Mary Nash Stoddard's Blog, page 21
March 10, 2012
ARTHRITIS SUFFERER IMPROVED BY AVOIDING ASPARTAME
http://www.wisegeek.com/what-are-some-foods-that-cause-gout.htm
1. Drinking more liquids is a must. For me, drinking more water also helped me lose weight, so that was two pluses for me. Drink lots of water.
2. Beverages with additives, such as artificial sweeteners (Aspartame), etc. will not work as well and may have other harmful effects. Obviously, sodas are bad, so are many trendy drinks like Red Bull and Sobe teas. Yes, tea is generally good, but that's if you brew it yourself, not when you buy it in a bottle - just check all the stuff that's listed on the labels to scare you off. When you drink other beverages, keep them natural and clear.
3. Refined sugar and artificial sweeteners, are bad for many other reasons, but the lesson for gout sufferers is that they reduce the kidney's effectiveness. Avoid sugars/artificial sweeteners.
4. Speaking of the kidneys, check to see if your kidneys are healthy. My bouts of gout started after my gall bladder was removed and while I can't be sure, my guess is that my other organs and especially my kidneys, now have to work harder and perform functions they were not used to doing before. Remember, your kidneys are your body's filters (some people worry more about the oil filter in their car than the one in their own body). Keep your filters (kidneys) healthy.
5. Fat, especially animal fat, is bad for gout sufferers and so is excessive protein. I think we can all agree on that - sorry Dr. Atkins. As was mentioned, sushi is especially bad, it's made of uncooked (i.e., produces more uric acid) fish, which is high in protein and fat. Add the fact that it's usually overly salty and eaten with a beer, and you've got one heck of a gout producer. Try making your own sushi with brown rice and veggies -- it's not that bad, really. Avoid fat and protein.
6. We eat too much bad food because it's easy and convenient. We can survive on much less. Is it any wonder that gout is most pronounced in the richest countries? Yes, it certainly occurs in countries like India as mentioned above, but it is much more rare.
7. We all seem to have trigger foods, but that's not the whole picture. Some of these may not be bad in and of themselves, but combined with other foods and excess, they can produce an attack. Perhaps a condiment or a drink added to the food's potency? Maybe a medication was a conduit rather than the cause? How long ago did you eat that food or take that medicine? So yes, it takes a lot of note-taking to identify your own trigger foods, but it's the only way to establish baselines and get a handle on your own triggers. Did I mention that all our bodies are chemically different, too? Create a food diary and look for patterns.
8. Exercise is key. Let's think about what causes the attacks: crystals in the fluid between our joints. So logically, moving our joints helps move those along. I know some of us have debilitating gout conditions, but we should still try to exercise, even if that means hiding the TV remote and changing the channels manually. Seriously, there are yoga programs for the severely disabled, just do a search online for more info. Oh, and exercise also increases energy, produces endorphins (natural pain killers), and helps with weight loss.
9. Regarding weight, I wasn't more than 30 pounds overweight, but it was enough to contribute to my attacks. Now my attacks are far less frequent if I keep my weight in check. Lots of people have trouble loosing weight, and from what I've read, it's because they want to lose too much too fast. It took years to accumulate it, so why do we expect it to come off in a few months, or weeks? I simply add my weight to my food diary. Funny thing is, just writing it down and being conscious of it, keeps me from gaining too much. Lose weight, slowly.
10. What to eat. My mother always said, if it's colorful, if it crunches, if it tastes bitter or sour, or if it makes you sweat, it's probably good for you. Now, as for gout, there are a few foods that could be triggers for some of us, but generally we can simplify this rule to: eat lots of colorful and creative salads. It's easy to remember, and if there is a lentil or some cauliflower in there, it's probably much better for you than the pork chops. And I try to use simple vinegar & olive oil dressings too, although as mentioned above, not the sweet ones (may contain Aspartame/Neotame). Finally, skip the cured meats, cheeses, and sweet toppings - those little orange wedges are probably from a can anyhow. Eats lots of salads.
11. As for grocery shopping, I heard this on Oprah: avoid the aisles where all the packaged foods are and stay in the periphery where the vegetables, fruits, dairy and fresh foods are. Seems self-evident enough, but if you read how grocery stores use music, colors, and suggestive psychology to get us to spend more on bad foods, you will also realize how hard it is to stick to your plan (grocery stores are probably the one place where you should keep your iPod on). When grocery shopping, stay on the periphery.
12. Perhaps this is a foregone conclusion, but eat organic. There are lots of "green" labels on foods, but the "organic" one is the most comprehensive. Organic foods will have less additives, chemicals, and preservatives. Yes, organic foods are more expensive, but nothing compared to the mess we will be taking if we continue to eat overly-processed foods.
In the end, it all boils down pretty much to what we learned when we were children: eat your veggies, drink your milk, and exercise. When we were young we didn't worry much about the milk and veggies, but unfortunately these days, we need to make sure they are healthy too.
1. Drinking more liquids is a must. For me, drinking more water also helped me lose weight, so that was two pluses for me. Drink lots of water.
2. Beverages with additives, such as artificial sweeteners (Aspartame), etc. will not work as well and may have other harmful effects. Obviously, sodas are bad, so are many trendy drinks like Red Bull and Sobe teas. Yes, tea is generally good, but that's if you brew it yourself, not when you buy it in a bottle - just check all the stuff that's listed on the labels to scare you off. When you drink other beverages, keep them natural and clear.
3. Refined sugar and artificial sweeteners, are bad for many other reasons, but the lesson for gout sufferers is that they reduce the kidney's effectiveness. Avoid sugars/artificial sweeteners.
4. Speaking of the kidneys, check to see if your kidneys are healthy. My bouts of gout started after my gall bladder was removed and while I can't be sure, my guess is that my other organs and especially my kidneys, now have to work harder and perform functions they were not used to doing before. Remember, your kidneys are your body's filters (some people worry more about the oil filter in their car than the one in their own body). Keep your filters (kidneys) healthy.
5. Fat, especially animal fat, is bad for gout sufferers and so is excessive protein. I think we can all agree on that - sorry Dr. Atkins. As was mentioned, sushi is especially bad, it's made of uncooked (i.e., produces more uric acid) fish, which is high in protein and fat. Add the fact that it's usually overly salty and eaten with a beer, and you've got one heck of a gout producer. Try making your own sushi with brown rice and veggies -- it's not that bad, really. Avoid fat and protein.
6. We eat too much bad food because it's easy and convenient. We can survive on much less. Is it any wonder that gout is most pronounced in the richest countries? Yes, it certainly occurs in countries like India as mentioned above, but it is much more rare.
7. We all seem to have trigger foods, but that's not the whole picture. Some of these may not be bad in and of themselves, but combined with other foods and excess, they can produce an attack. Perhaps a condiment or a drink added to the food's potency? Maybe a medication was a conduit rather than the cause? How long ago did you eat that food or take that medicine? So yes, it takes a lot of note-taking to identify your own trigger foods, but it's the only way to establish baselines and get a handle on your own triggers. Did I mention that all our bodies are chemically different, too? Create a food diary and look for patterns.
8. Exercise is key. Let's think about what causes the attacks: crystals in the fluid between our joints. So logically, moving our joints helps move those along. I know some of us have debilitating gout conditions, but we should still try to exercise, even if that means hiding the TV remote and changing the channels manually. Seriously, there are yoga programs for the severely disabled, just do a search online for more info. Oh, and exercise also increases energy, produces endorphins (natural pain killers), and helps with weight loss.
9. Regarding weight, I wasn't more than 30 pounds overweight, but it was enough to contribute to my attacks. Now my attacks are far less frequent if I keep my weight in check. Lots of people have trouble loosing weight, and from what I've read, it's because they want to lose too much too fast. It took years to accumulate it, so why do we expect it to come off in a few months, or weeks? I simply add my weight to my food diary. Funny thing is, just writing it down and being conscious of it, keeps me from gaining too much. Lose weight, slowly.
10. What to eat. My mother always said, if it's colorful, if it crunches, if it tastes bitter or sour, or if it makes you sweat, it's probably good for you. Now, as for gout, there are a few foods that could be triggers for some of us, but generally we can simplify this rule to: eat lots of colorful and creative salads. It's easy to remember, and if there is a lentil or some cauliflower in there, it's probably much better for you than the pork chops. And I try to use simple vinegar & olive oil dressings too, although as mentioned above, not the sweet ones (may contain Aspartame/Neotame). Finally, skip the cured meats, cheeses, and sweet toppings - those little orange wedges are probably from a can anyhow. Eats lots of salads.
11. As for grocery shopping, I heard this on Oprah: avoid the aisles where all the packaged foods are and stay in the periphery where the vegetables, fruits, dairy and fresh foods are. Seems self-evident enough, but if you read how grocery stores use music, colors, and suggestive psychology to get us to spend more on bad foods, you will also realize how hard it is to stick to your plan (grocery stores are probably the one place where you should keep your iPod on). When grocery shopping, stay on the periphery.
12. Perhaps this is a foregone conclusion, but eat organic. There are lots of "green" labels on foods, but the "organic" one is the most comprehensive. Organic foods will have less additives, chemicals, and preservatives. Yes, organic foods are more expensive, but nothing compared to the mess we will be taking if we continue to eat overly-processed foods.
In the end, it all boils down pretty much to what we learned when we were children: eat your veggies, drink your milk, and exercise. When we were young we didn't worry much about the milk and veggies, but unfortunately these days, we need to make sure they are healthy too.
March 4, 2012
More evidence of Diet Soda's addictive properties (10% wood alcohol in Aspartame)
Learn more at: http://www.aspartamesafety.comFollow: marystod@Twitter.com
http://health.yahoo.net/experts/dayinhealth/diet-soda-addictive Is Diet Soda Addictive?By Lisa Collier Cool
Feb 22, 2012Darren Jones wants to check himself into rehab for an unusual "addiction." He says he's so hooked on Diet Coke that he downs 18 cans a day and can't leave home without it. Judging by his photos in The Daily Mail, all that diet soda hasn't helped him control his weight, which was edging toward 500 pounds when the pictures were taken.He's not alone. Former president Bill Clinton, Victoria Beckham, Elton John and movie moguls Harvey Weinstein and Jeffrey Katzenberg have all admitted to a Diet Coke habit, according to the New York Times. And then there's Elisa Zied, a high profile registered dietician with no discernible weight problem and three books and numerous TV appearances to her credit. Last year she confessed to a Diet Coke addiction on Twitter, a deliberate strategy -she said she hoped that "putting it out there would make me accountable".Replace soda with these healthy smoothie recipes.The Addiction QuestionSurveys show that people who drink these beverages rarely stop with just one. In fact, the typical consumer of diet sodas downs an average of more than 26 ounces per day, and 3 percent of diet-soda drinkers have at least four per day. But are hardcore diet soda fiends actually hooked?If there's anything in diet colas that could be addicting, the most likely suspect is caffeine (although many diet soda guzzlers prefer caffeine-free colas). Besides, comparisons with coffee show that cola can't deliver the caffeine kick equal to a cup of java. An 8-ounce Diet Coke gives you a measly 47 milligrams of caffeine, compared to 133 in a cup of ordinary coffee and 320 in a Starbucks' grande.Insights from Brain ScienceAnother plausible explanation is habit: diet soda becomes part of daily rituals - a break from work, lunch, watching the news, you name it. And sipping a zero-calorie beverage may not seem to have downside to curb the urge to overindulge.More persuasive, perhaps, is the notion that artificial sweeteners trigger the brain's reward system. In a study of women who drank water sweetened with sugar or Splenda, the women couldn't taste the difference between the two, but functional MRIs showed that the brain's reward system responded more strongly to sugar. Study author Martin P. Paulus, MD, a professor of psychiatry at the University of California San Diego suggests that diet soda might be addicting because "artificial sweeteners have positive reinforcing effects - meaning humans will work for it, like for other foods, alcohol and even drugs of abuse."Is diet soda making you fat? Is Diet Soda Harmful?Beyond the addiction issue, diet soda has been linked to increased rates of heart attack and stroke, kidney problems, preterm deliveries, and, yes, weight gain. While not yet carved in scientific stone, the emerging evidence is a bit disturbing. Here's a rundown:· Heart Attack and Stroke: Drinking diet sodas daily may increase the risks for heart attack and stroke and other vascular events by 43 percent, but no such threat exists with regular soft drinks or with less frequent consumption of diet soda. These results come from a study including more than 2,500 adults published online in the Journal of General Internal Medicine on January 30, 2012. So far, no one knows what it is about diet sodas that could explain the added risk. · Kidney Trouble: In 2009, researchers at Harvard found that drinking two or more diet sodas daily could lead to a 30 percent drop in a measure of kidney function in women. No accelerated decline was seen in women who drank less than two diet sodas daily. The drop held true even after the researchers accounted for age, high blood pressure, diabetes and physical activity.· Preterm Delivery: A Danish study including more than 59,000 women found a link between drinking one or more diet sodas daily and a 38 percent increase in the risk of giving birth to preterm babies; the risk was 78 percent higher among pregnant women who drank four or more diet sodas daily. No such risk was seen with regular soda. · Weight Gain: Wouldn't it be ironic if instead of helping you lose weight, diet sodas had the opposite effect? A study at the University of Texas Health Science Center at San Antonio found that compared to those who drank no diet sodas, study participants who did had a 70 percent greater increase in waist circumference; worse, drinking two or more diet sodas daily led to ballooning waist circumference that was 500 percent greater than those who drank none. This doesn't prove that diet soda is to blame since the study was observational - it could be that participants began gaining weight and then started drinking diet sodas.
March 3, 2012
Dry Eye & Dry Mouth Syndrome in Aspartame Users
(from the files of Aspartame Consumer Safety Network and The Townsend Letter for Doctors)
"Dry Eyes" from Use of Aspartame (NutraSweet)Associated Insights Concerning the Sjogren SyndromeThe Townsend Letter for Doctors, Jan. 1994by H. J. Roberts, M.D., FCCP, FACA, 300-27th St., West Palm Beach, FL 33407-5299 (407) 832-2408
MethodsData were obtained from 551 persons who appeared to have systemic reactions to aspartame. They consisted of 160 private patients or aspartame reactors who were personally interviewed, and 391 individuals who described their adverse side effects in the survey questionnaire...including observations after rechallenge. The names of the latter group were supplied by Aspartame Victims and Their Friends (courtesy of Mrs. Shannon Wroth), the Community Nutrition Institute (courtesy of Mr. Rod Leonard), and Dr. Woodrow Monte of Arizona State University.
ResultsDry eyes, ocular irritation from contact lens, or both, occurred in 46 (8.3%) aspartame reactors, In addition to the sensation of local discomfort and "sand" in the eyes, the eyelids of such patients tend to become swollen and infected, at times with loss of eyelashes.
Recent aspartame-associated dry eyes and severe depression - 18 (4.9%)Recent aspartame-associated dry eyes and marked memory loss - 20 (5.5%)Recent aspartame-associated dry eyes and severe mental confusion - 9 (2.4%)
Representative Case ReportsCase 1 - A 47 year-old woman complained of severe dryness of the eyes that required one bottle of artificial tears a week. Her consumption of aspartame included 10-12 glasses or cups of aspartame-sweetened beverages, the addition of a tabletop sweetener to 3 cups of coffee in the morning, and considerable aspartame pudding. She also suffered confusion, significant memory loss, intense headaches (never previously a problem), impaired hearing, lightheadedness, severe "nervousness," muscle cramps, and depressions with suicidal thoughts. These symptoms markedly improved after stopping aspartame, and disappeared within several weeks. She no longer required artificial tears. Such dramatic improvement enabled her to travel abroad several weeks later with her church group for relief work.
CommentThe unexpected associated of aspartame use and dry eyes offers clues concerning this symptom and the Sjogren syndrome. Other problems encountered in aspartame reactors, especially dry mouth and joint pains provide related insights.
"Dry Eyes" from Use of Aspartame (NutraSweet)Associated Insights Concerning the Sjogren SyndromeThe Townsend Letter for Doctors, Jan. 1994by H. J. Roberts, M.D., FCCP, FACA, 300-27th St., West Palm Beach, FL 33407-5299 (407) 832-2408
"It is of use from time to time to take stock, so to speak of our knowledge of a particular disease, to see exactly where we stand in regard to it, to inquire what conclusions the accumulated facts seem to point to, and to ascertain in what direction we may look for fruitful investigations in the future." Sir William OslerAbstract"Dry eyes" and associated difficulty in wearing contact lenses were prominent complaints offered by 56 (8.3%) of 551 aspartame reactors. Xerostomia (dry mouth) was a frequent concomitant. The symptoms promptly improved after they stopped aspartame-containing products, and predictably recurred on aspartame rechallenge. The concomitant joint pains, severe confusion, memory loss and depression also have clinical significance, with special reference to the Sjogren syndrome.
The cause and management of "dry eyes" challenge ophthalmologists and primary care physicians. This symptom was unexpectedly and repeatedly encountered among patients manifesting other reactions to products containing aspartame, a sweetener currently being consumed by 54% of adults in the United States. This complaint was encountered in both the routine questioning of apparent aspartame reactors and a computerized, 9-page survey of such individuals. Many also volunteered difficulty in wearing contact lenses due to decreased tears, dry mouth (xerostomia), joint pains, confusion and memory loss - all specifically attributed to the use of aspartame products.
MethodsData were obtained from 551 persons who appeared to have systemic reactions to aspartame. They consisted of 160 private patients or aspartame reactors who were personally interviewed, and 391 individuals who described their adverse side effects in the survey questionnaire...including observations after rechallenge. The names of the latter group were supplied by Aspartame Victims and Their Friends (courtesy of Mrs. Shannon Wroth), the Community Nutrition Institute (courtesy of Mr. Rod Leonard), and Dr. Woodrow Monte of Arizona State University.
The completed questionnaires were analyzed with the assistance of the Management Information System staff at the Good Samaritan Hospital, West Palm Beach, Florida.
ResultsDry eyes, ocular irritation from contact lens, or both, occurred in 46 (8.3%) aspartame reactors, In addition to the sensation of local discomfort and "sand" in the eyes, the eyelids of such patients tend to become swollen and infected, at times with loss of eyelashes.
The causative or contributory role of aspartame was indicated by these clear-cut clinical correlates: (1) prompt and gratifying improvement of ocular and other symptoms following the cessation of aspartame, generally within several days; and (2) their recurrence shortly after resuming such products. This sequence predictably recurred after rechallenge with aspartame, known or inadvertent.
These observations have been duplicated by more than a score of patients complaining of dry eyes in subsequent aspartame reactors. There were related problems. For example, a physician who consumed considerable diet sodas developed a type of corneal dystrophy generally associated with the chronic use of certain drugs (e.g., indomethacin).
Computerized correlations between aspartame-associated dry eyes, and "marked memory loss," "severe depression" and "severe mental confusion" were done on the first 362 aspartame reactors who completed the questionnaire. (There was a 30.8% response to the initial mailing of 1,177 forms.) The correlates were as follows:
Recent aspartame-associated dry eyes and severe depression - 18 (4.9%)Recent aspartame-associated dry eyes and marked memory loss - 20 (5.5%)Recent aspartame-associated dry eyes and severe mental confusion - 9 (2.4%)
Other complaints offered by the larger cohort had considerable significance, with particular reference to the Sjogren syndrome. They included excessive thirst due to dry mouth (xerostomia) in 65 (12%), and severe joint pains in 58 (11%). It is noteworthy that three-fourths of patients in this and the large series of aspartame reactors were women averaging 50 years, a phenomenon also encountered in the Sjogren syndrome.
Representative Case ReportsCase 1 - A 47 year-old woman complained of severe dryness of the eyes that required one bottle of artificial tears a week. Her consumption of aspartame included 10-12 glasses or cups of aspartame-sweetened beverages, the addition of a tabletop sweetener to 3 cups of coffee in the morning, and considerable aspartame pudding. She also suffered confusion, significant memory loss, intense headaches (never previously a problem), impaired hearing, lightheadedness, severe "nervousness," muscle cramps, and depressions with suicidal thoughts. These symptoms markedly improved after stopping aspartame, and disappeared within several weeks. She no longer required artificial tears. Such dramatic improvement enabled her to travel abroad several weeks later with her church group for relief work.
Case 2 - A 36 year-old businesswoman complained of recent difficulty wearing contact lenses. She had been consuming considerable amounts of soft drinks and gum containing aspartame. These and other symptoms - including lightheadedness, headache and leg cramps - abated within two weeks after all aspartame products were avoided.
Case 3 - a 61 year-old female court reporter developed dry eyes and bilateral blurring of vision. Other recent complaints included marked memory loss, severe headache, dizziness, extreme irritability, and atypical facial and joint pains. As a result, she had been making many errors at work. The patient improved "immediately" when she ran out of aspartame-containing beverages, and resumed regular sodas. She therefore deduced that aspartame products had been causing her problems. Her previous daily consumption included 4 cans of aspartame soft drinks, 2 glasses of aspartame hot chocolate, and 6 packets of an aspartame tabletop sweetener.
CommentThe unexpected associated of aspartame use and dry eyes offers clues concerning this symptom and the Sjogren syndrome. Other problems encountered in aspartame reactors, especially dry mouth and joint pains provide related insights.
Two reactors who complained of "thick saliva" developed enlargement and tenderness of the parotid glands. The secretory structures of the salivary glands presumably had been affected by aspartame, as well as the lacrimal glands. The affinity of aspartame for salivary glands were demonstrated experimentally by the prompt uptake of isotopically-labelled aspartame.
The Sjogren or sicca syndrome affects an estimated 2% of the adult population. The reduction or absence of lacrimal and salivary secretions results in dry eyes and dryness of the mouth. (The diagnostic lipstick-on-teeth sign consists of lipstick adhering to the upper front teeth). This disorder is presently regarding as a chronic autoimmune disorder resulting from lymphocyte-mediated destruction of these glands and changes in the points.
A vicious cycle is likely to ensue if considerable aspartame-containing beverages are consumed because of the intense thirst created by severe dryness of the mouth. Weiffenbach et al. demonstrated that taste impairment is not a necessary consequence of salivary gland dysfunction among patients with "dry mouth" caused b the chronic absence of saliva. Accordingly, such individuals may come to prefer the taste of aspartame in satisfying their chronic thirst, with perpetuation of the sicca syndrome.
The systemic and central nervous system sequelae of the Sjogren syndrome underscore the potential importance of these findings. Cognitive impairment and lamenting features have been reported by one-fourth of Sjogren patients. Severe confusion and memory loss also were noted in 157 (28.5%) aspartame reactors in the present series. Indeed, many reactors in their third and fourth decades asked, "Could I be developing early Alzheimer's disease?" The prompt and impressive regression of their confusion and memory impairment after abstinence from aspartame proved reassuring.
Several phenomenon may explain cerebral dysfunction associated with aspartame use. They include flooding of the brain with large amounts of phenylalanine (50% of the aspartame molecule), disturbances of neurotransmitters (especially dopamine), other effects of its three chemical components (phenylalanine, aspartic acid, methanol), methanol-induced cerebral edema, and glucopenia due to increased insulin release and concomitant decreased food intake in an attempt to lose weight.
February 26, 2012
Consumer Advocate Team of Turner & Stoddard Talk Aspartame Safety Issues
Are Artificial Sweeteners Really Safe? Ask the Experts
For over two decades, experts sounded the warnings on artificial sweeteners - citing the scientific research showing harm. With backgrounds in Law and Journalism, they answer the questions everyone is asking today. Are aspartame and sucralose really safe? Are Class Action suits in the works? This topic is 'hotter than hot,' with new sweeteners like Neotame and Splenda approved by FDA for foods, drinks, medications, vitamins and gum. How safe is our food supply?
(PRWEB) October 17, 2005 -- For over two decades, experts on artificial sweeteners sounded the warnings. With backgrounds in Law and Journalism, they answer the questions everyone is asking today. Are aspartame and sucralose really safe? Are Class Action suits in the works?
This topic is 'hotter than hot,' with new sweeteners like Neotame and Splenda approved by the FDA for foods, drinks, medications, vitamins and gum. How safe is our food supply?
In 1987, Washington consumer advocate, James Turner, Esq., asked broadcast journalist and appointed Texas state judge, Mary Nash Stoddard to head the fledgling anti-aspartame movement and take it international, which she did and the rest is history.
For nearly two decades, Aspartame Consumer Safety Network has supplied scientific, documented information and support to mainstream media, other consumer organizations, the general public, and health care professionals on five continents. Following the brain tumor death of her young husband, in 1985, Stoddard suffered a serious reaction (Eosinophilia) to the artificial sweetener, aspartame. Upon cessation of use, her symptoms abated.
Stoddard kicked the campaign into high gear when she gave testimony at the November 3, 1987 Senate Hearings on the safety of aspartame. She and Aspartame Consumer Safety Network cofounder, Turner are the only campaigners on the Internet who were actually there to give Senators their testimony. They are the only ones on the net who have qualified in court as Expert Medical Witnesses on this topic.
Stoddard was a member of the national President's Council On Food Safety from 1998 to 1999 and a current voting member of the Texas Radio Hall of Fame. She received an award for her work from the government of Mexico, following a keynote address to their conference on sweeteners in 1998. Stoddard was the first non-M.D. paid to teach a class on aspartame safety at University of Texas Southwestern Medical School in Dallas, and has guest lectured at colleges and universities all over the U.S.
Long before artificial sweeteners became a 'hot' topic, the team of Stoddard and Turner were heating up broadcasting airwaves and generating dozens of articles in print [in flying magazines and top newspapers all over the world, to their credit. Appearing nationally on NBC's TODAY Show, CBS' Sixty Minutes and CNN. With articles about ACSN leaders in The Dallas Morning News, Mademoiselle magazine, The Washington Post, The Guardian, The New York Post, U.S. Air Force Flying Safety magazine, London Daily Mirror and others.
Thousands of websites have jumped on the bandwagon to echo Stoddard's and Turner's warnings, using the information disseminated originally, by Dallas and Washington based, Aspartame Consumer Safety Network, founded in 1987.
One strangely anonymous source even went so far as to turn ACSN's well documented scientific information into bizarre gibberish - in the so-called, Nancy Markle email - resulting in a botched attempt to discredit Stoddard and Turner's credibility with media and the public.
Are there safe alternatives to artificial sweeteners such as aspartame/Equal & NutraSweet and the new sucralose/Splenda? Ask Stoddard and Turner. They know.
(Stoddard and Turner are available for interview by calling: 214.387.4001)
Bios available on: www.aspartamesafety.com
Consumer Advocates Take On The US FDA Over Aspartame Approval
Our friend of 25 years, UPI's Greg Gordon, was the first major media member to do an in-depth report on the tragic history of Aspartame's approval by our US Food and Drug Administration in 1981. As he covered the Senate Hearings on Aspartame Safety in Washington DC, Gordon succeeded in pointing out the criminal acts associated with the obviously botched process. Acts we continue to be forced to deal with in our lives, as Aspartame and it's horrific encore act, Neotame, swirl out to pollute ours along with the rest of the world's food supply.
I have spoken, in person (in Washington D.C. and elsewhere) with most of these people and some are even good friends to this day.The List includes the following: (Researchers/Scientists/Aspartame Victims, Pharmaceutical Ind. CEOs, FDA, FAA Officials, Senators, reporter, Greg Gordon, etc.)
Regretfully, some of our Aspartame Awareness Campaign's staunchest supporters, my dear friends, (Jacqueline Verrett, Adrian Gross, Joyce Wilson, Sen. Metzenbaum, Sen. Ted Kennedy and others) are no longer with us and I miss them. --
Mary Nash Stoddard, Founder Aspartame Consumer Safety Network and Pilot Hotline (1987-present)/author Deadly Deception Story of Aspartame (Odenwald Press 1998)
I have spoken, in person (in Washington D.C. and elsewhere) with most of these people and some are even good friends to this day.The List includes the following: (Researchers/Scientists/Aspartame Victims, Pharmaceutical Ind. CEOs, FDA, FAA Officials, Senators, reporter, Greg Gordon, etc.)
Regretfully, some of our Aspartame Awareness Campaign's staunchest supporters, my dear friends, (Jacqueline Verrett, Adrian Gross, Joyce Wilson, Sen. Metzenbaum, Sen. Ted Kennedy and others) are no longer with us and I miss them. --
Mary Nash Stoddard, Founder Aspartame Consumer Safety Network and Pilot Hotline (1987-present)/author Deadly Deception Story of Aspartame (Odenwald Press 1998)
February 24, 2012
GREG GORDON, UPI INVESTIGATIVE REPORT ON ASPARTAME 10/87:...
GREG GORDON, UPI INVESTIGATIVE REPORT ON ASPARTAME 10/87:
Part One of Three:
UPI Investigative Report 1987NutraSweet:Questions SwirlPart 1: DID SEARLE IGNORE EARLY WARNING SIGNS ?By GREGORY GORDON WASHINGTON (UPI) ≠ A University of Illinois scientist says he warnedthe G.D.Searle Co. years before NutraSweet swept the diet food and softdrink markets that the companyís new artificial sweetener could heightenrisks of brain damage in fetuses and small children. Dr. Reuben Matalon, a pediatrician and geneticist, said that between1976 and 1984, he prodded Searle officials several times to do moreresearch on the issue, but Searle never performed the studies suggested. The Chicago-based company did, however, pursue U.S. government approvalfor the low-calorie sugar substitute, and got it in a controversialruling in 1981. Today, tens of millions of Americans guzzle diet soft drinks stampedwith the NutraSweet "Swirl", dump packets of the NutraSweet tabletopsweetener, "Equal" in their coffee and consume NutraSweet-flavoredcereal, puddings, gelatins, cheesecake, chewing gum or vitamin tablets. The Food and Drug Administration, despite receiving more than 3,600consumer complaints, is so confident of the sweeteners safety that itrecently expanded uses to frozen and chilled fruit juices. Matalon, however, has remained skeptical. In May, he reported that hisinitial, federally funded tests on 51 adults suggests heavy NutraSweetconsumption may increase blood levels of a key amino acid enough toaffect attention span, memory and concentration in some people,particularly small children. Pregnant women who are sensitive to thesweetenerís main component, the amino acid phenylalanine, also may faceheightened risk that their infants will have birth defects, Matalonsaid. More than a dozen other scientists, some of whom are conductingclinical studies, also say they suspect that subtle effects of the sweetpowder could pose a major health problem. They believe NutraSweet ≠known generically as aspartame, is linked to brain damage, epilepticseizures, eyesight problems, allergic reactions, headaches or dizziness. "The likelihood is very strong that aspartame does produce serious andpotentially damaging brain effects in a number of people", said RichardWurtman, a neuroscientist at the Massachusetts Institute of Technologywho is studying scores of people who suffered seizures after usingNutraSweet. Facing continuing controversy, The NutraSweet Co., the name adopted bySearleís NutraSweet Division following its 1985 sale to the giantMonsanto Co., vouches for the sweetener. The firmís president, Robert Shapiro, rejects criticism voiced byMatalon and others, saying, "The fact is that the world scientificcommunity has considered these very specific allegations repeatedly, andhas come to the same conclusion as the FDA." An eight-month United Press International investigation not only turnedup scientific concerns, but also raised questions about the way theproduct was approved, about the independence and depth of the industry-funded research efforts into its safety, and about "revolving door"relationships between FDA officials including former FDA commissionerArthur Hull Hayes Jr. and the food and drink industries. Shapiro, who obtained an advance copy of this UPI report, said, "Takenas a whole, the effect of the article is likely to be a thoroughlymisleading impression of the state of knowledge of the subject." Companyspokesman Thym Smith said the firm is contemplating litigation. Senator Howard Metzenbaum, D-Ohio, a leading skeptic of the FDAísapproval who plans to hold a hearing on NutraSweet in the next fewweeks, said, "I don't have hard evidence that the product is not safe.But, I am convinced that there is no hard evidence...that the product issafe." FDA officials stress they have yet to see hard data disproving thesweeteners safety. For that reason, the agency last year rejected aconsumer groupís petition to ban it on grounds that 140 users sufferedseizures and eye problems. NutraSweet has been at the center of intense controversy almost sinceJuly 18, 1981, the day Hayes approved its use in dry foods. Indeed, inrendering his decision, Hayes overrode six of the nine scientists on twoagency review panels who felt studies on itís possible links to braintumors in rats has been inadequate. Since then, some independent scientists have become unusuallyoutspoken.Drs. Louis Elsas of Emory University and William Pardridge of the UCLAMedical School charged that the diet food and drink industry has engagedin a "whitewash" by rejecting health concerns, manipulating researchstudies and wining and dining scientific critics. These and other researchers describe a world of subtle, high-stakesstrategy in which the availability of corporate funds and the design ofresearch protocols may have influenced the course of a multibillion-dollar industry and potentially affected the safety of millions ofpeople. The NutraSweet Co. and a non-profit industry group reject theseallegations, asserting they have commissioned scores of studies to testthe product's safety and that decisions on research funding are madesolely on merit. Company spokesman Smith said NutraSweetís "phenomenalsafety record is the result of the well known nature of the productrather than manipulations of management." Consumer complaints aboutNutraSweet surged in 1983, after Hayesí deputy, Mark Novitch, with thecommissioners support, approved its use in soft drinks such as "DietCoke" and "Crystal Light", sending consumption soaring. UCLAís Pardridge noted in a letter to the American Medical AssociationJournal last year that, with aspartame, the food industry now is addingabout five million pounds of phenylalanine ≠ "a known neurotoxin" to thefood supply every year. Roy Burry, an analyst with Kidder-Peabody, Inc., said the explodingdiet market now accounts for 24 percent of soft drink sales, comparedwith 10 percent in the 1970ís, and is growing at 20 to 25 percent ayear. The NutraSweet Co.ís sales are no longer public, but last year revenueswere believed to have exceeded previously stated levels of $700 million. So intense has been the NutraSweet advertising campaign that the dietfood and beverage industry created a "NutraSweet World ProfessionalFigure Skating Championship." "Taking good care of oneself makes life a little better- and NutraSweetmakes it a little sweeter!" boasted one ad during a TV fitness program. The NutraSweet Co. also has paid up to $3 million a year for a 100-person public relations effort by the Chicago offices of Burson,Marsteller, a former employee of the New York PR firm said. The employeesaid Burson Marsteller has hired numerous scientists and physicians,often at $1,000 a day, to defend the sweetener in media interviews andother public forums. Burson Marsteller declines to discuss such matters. Dismissing safety fears, The NutraSweet Co. stresses that its product,which in raw form, is 180 times sweeter than sugar, has been endorsed bythe AMA and other scientific bodies worldwide. Actually, the AMAísCouncil of Scientific Affairs gave a qualified endorsement based on"available evidence", including company-funded studies that werechallenged by FDA task forces during investigations of the firmíslaboratory practices in the 1970ís. Of 69 scientists who responded to a recent General Accounting Officesurvey, 28 said they felt more research was needed on NutraSweet and adozen of those questioned considered it a major health problem. An "aspartame victims" group has formed, a consumer group has pressedlegal challenges and the company faces at least three personal injurysuits. In one suit, Jim Stoddard, 32, a diabetic in Grand Rapids,Michigan, charged that his heavy NutraSweet consumption triggered adozen seizures-the last one so violent he dislocated his shoulder andfractured his collar bone. Stoddardís lawyer, and his sister, Cynthia, alleged he suffered braindamage and now has trouble understanding words because he consumed aproduct inadequately tested by Searle. She said she withdrew the suitrecently for tactical reasons but would refile it early next year. Thecompany denies the allegations. Wurtman, who quit his job as a Searle consultant and became a vocalNutraSweet opponent, said he has been contacted by more than 200 personswho suspect they suffered seizures as a result of NutraSweet use. He said Dr. Gerald Gaull, a Searle vice president, visited hislaboratory in 1985 and threatened to veto funding by ILSI(InternationalLife Sciences Institute), the Washington-based tax-exempt foundation,for his planned study into whether NutraSweet changes brain chemistry,lowering some humansí seizure thresholds. Gaull said, "thereís no way" Searle, with one of 12 votes on the ILSIpanel, could veto a grant decision, but he did not deny making thethreat. ILSI ultimately turned away Wurtman on grounds that Searle already hadarranged for seizure studies at Yale University and New Yorkís MountSinai Hospital ≠ studies that have drawn criticism because humanvolunteers were given aspartame only once or twice. Wurtman said he is now tapping his laboratoryís budget, which isextremely limited, slowing progress on his own studies. "Aspartame maybe a serious health hazard," he said, "Itís critically important thathigh quality research now be done to assess this hazard." In his letterto the AMA Journal, Pardridge said no one has fully researched thedegree to which aspartame raises phenylalanine levels on the brain and,if so, what the possible effects are. He said in an interview, after heraised questions about the sweetenerís effects on children, that ILSIrejected his two grant proposals in 1985. Last year, he said, Gaullpressed him at a conference in Colorado to prove that phenylalanine, oneof twenty-one amino acids, causes brain damage. "It was incredible for him to ask that," Pardridge said. "That was thebasis for my ILSI grant (proposal)." "Thereís an internal conflict of interest," he said, "when a company,which has profit at the bottom line, is charged with finding out thetrue safety of its product." Elsas, who publicly assailed NutraSweet in 1985, said he was put offfor a year before ILSI rejected his proposal without stating a reason.ILSIís executive director, Jack Filer, asserted research proposals wererejected because they cost too much or lacked scientific merit. While denying funding for these aspartame skeptics, the company(G.D.Searle/NutraSweet Co.) and ILSI have financed researchers with whomthey have long-running relationships. A number of industry-fundedscientists acknowledged that company and ILSI officials originated ideasfor their studies or participated in the research design. These studiesgenerally have reported the sweetener is safe. Consumer lawyer Turner said, "The notion that an industrial companywould take large sums of money and parcel it out to scientificconsulting firms and university departments, who they consider to bepersonal and commercial allies is an unconscionable way to ensure thesafety of the American food supply." He said the NutraSweet experience shows that "the entire system of theway scientific research is done needs to be carefully investigated,evaluated, and revamped." Food industry officials also said most studies financed by Searle orthe NutraSweet Co. have been arranged as contracts, rather than grants.Smith said the company often uses contracts "to accomplish a specificresearch task." James Scala, former director of health sciences for the General FoodsCorp., a major NutraSweet user, said that a scientist working undercontract became "more of an arm of the Searle research group than agrantee." Scala, now with the Shaklee Corp., also said that most early NutraSweetresearch consisted of short-term studies that ignored possible "subtle,"long-term effects. Matalon said, "Let us say cigarettes were invented today, and you give20 people two packs a day and after six weeks, no one has cancer, wouldyou say that it was safe? Thatís what they did with NutraSweet." Dr. Martha Freeman, who was a medical officer at the FDAís Bureau ofDrugs in the early 1970ís, argued in 1973 that the substance (aspartame)was "a new chemical...that doesn't occur naturally" and should only beapproved after long-term clinical studies, as if it were a new drug. Herarguments were rejected. Despite these complaints, the NutraSweet Co. has insisted that thecompany-funded studies prove that except for people with the raredisease, phenylketonuria, the human body processes phenylalanine inaspartame just like any other food, Thomas Stenzel, a spokesman for theInternational Food Information Council, a public relations arm forNutraSweetís manufacturers and biggest customers, contended scientificadversaries comprise a small minority. He said he found it "very important that the leading professionalhealth organizations" have found NutraSweet to be safe. For example, the American Academy of Pediatrics concluded in 1985 thatstudies on people given massive aspartame doses showed no dangerous risein blood phenylalanine levels; the Epilepsy Institute has reported thesweetener "to be safe for people with epilepsy." Filer, executive director of the industryís main organ, theInternational Life Sciences Institute, suggested that problems blamed onaspartame may stem from "water load" on the brain resulting from over-consumption of liquids. Maj. Michael Collings, who was an Air Force F-16 pilot in top physicalcondition, said he often drank up to a gallon of aspartame-sweetenedproducts when he finished his daily, five-to-eight mile jogs in Nevadaísdesert heat. After noticing slight trembling in his hands over severalweeks, he collapsed unconscious with a seizure on Oct.4, 1985, a lawyerfor Collings said. Because of the seizure, Collings is grounded as a pilot for life, is onmedication and was ordered transferred to Maxwell Air Force Base inAlabama at a $400-a-month pay reduction, said attorney Bryan Gould, whocharged in a state court suit last year that NutraSweet caused theseizure. "He tells me thereís no way to describe the feeling of flight," Gouldsaid. "He loves to fly and now he can't." The NutraSweet Co. denies anylink between the sweetener and Collings medical problems. FDA officials, while publicly endorsing aspartame, are watching thesituation closely. In late 1985, the agency took the unusual step ofasking doctors nationwide to report adverse reactions to NutraSweet, andanother food additive, sulfites ≠ a move normally reserved for drugs.Sulfites since have been banned from the market. A FDA spokesman saidabout 25 doctors filed reports suggesting aspartame links to varyinghealth problems. The FDA approved NutraSweet products on the condition they carry acompulsory warning to phenylketonurics, individuals sensitive to itsphenylalanine component. But Matalon, Elsas and others worry aboutmillions of "carriers" of the disease who are unaware of theirsensitivity. They say NutraSweet could damage fetuses of pregnant womenwhose bodies have trouble processing the amino acid. Matalon, on releasing his new study, urged that products be labeledwith the amount of NutraSweet they contain so consumers can monitortheir intake. In Canada, aspartame is the only food additive for whichsuch quantity food labeling is required. With consumption soaring, Sanford Miller, chief of FDAís Bureau ofFoods, has acknowledged considering a labeling requirement in thiscountry. Dr. Gary Flamm, the FDAís top toxicologist overseeing food additives,said that beyond labeling, once a food additive such as NutraSweet haswon approval, it is far more difficult to restrict its marketing. "If...our approval of it was a mistake, we couldn't rectify thatwithout data showing that aspartame was unsafe," said Flamm, anaspartame defender. Even then, he said, the agency would face a new regulatory thicketunless it could be shown NutraSweet posed "an imminent hazard." Consumer lawyer James Turner, who has campaigned for more than a decade for aNutraSweet ban, assailed the FDAís treatment of such safety issues."Once a product is on the market, whether there by nefarious or honestmeans," he said, "it is impossible to get it off the market until it hascaused severe, undeniable damage that has probably lasted over manyyears." Several independent scientists have alleged that the industry hassteered research money to allies in the scientific community, whiledenying funding to those who have raised health concerns. A number of scientists who pressed for more studies into possible braindamage told UPI they were turned away by Searle and the InternationalLife Sciences Institute, a tax-exempt industry foundation supported bythe company, its Japanese aspartame-manufacturing partner and 10 sellersof NutraSweet-flavored products. In interviews, Drs. Matalon, Wurtman, Elsas, Pardridge, and John Olneyof Washington University in Illinois charged that the industry has paidmillions of dollars for studies that have skirted the real issues aboutNutraSweet. "There are virtually no studies," Turner said, "that have been done byindividuals using resources other than the industryís that have given aclean bill of health to aspartame." University of Illinois researcher Matalon recalled that he couldnítpersuade Searle to do the kind of research necessary to put to restlingering health concerns, neither on his first approach in 1976 norwhen he submitted specific grant proposals to more four more companyofficials beginning in late 1980. After NutraSweet won FDA approval and began changing the dietary habitsof millions of Americans, Matalon said he lost patience in 1984 with theusual encouragement from Searle officials about prospects for futurefunding. "I felt they were just stringing me along," said Matalon, whoobtained a $180,000 grant from the National Institutes of Health. Company spokesman Smith said the NutraSweet manufacturer has "notdiscouraged Dr. Matalonís work, nor anyone elseís." While declining tocomment on the decision not to fund Matalonís study, Smith said thecompany spends "between $30 million and $35 million annually onresearch.""We do make decisions based on how we understand a study will beconducted and, reasonable scientists may disagree on study designs," hesaid.The company has alleged that a number of its critics are seeking topressure the industry to fund their laboratories. Faced with sharply differing opinions on the sweetenerís safety, theFDA and the National Institutes of Health, the governmentís chieffunding mechanism for private research, have financed few studies on itseffects. One former ranking NIH official, Artemis Simopoulos, argued theagency "should have a very extensive program on aspartame so peoplewould know" whether it is safe. Yet some NIH scientists have served as consultants to the ILSIfoundation, helping decide the awards of $500,000 in annual NutraSweetresearch grants in recent years. Even Simopoulos was a non-paid memberof the foundationís board. But ILSIís "aspartame technical committee," consisting of theNutraSweet Co. and 11 other manufacturers and users of sweetener, havebeen accused of discriminating against NutraSweet critics in grantingawards. Represented on the ILSI committee are General Foods, the Coca Cola Co.,PepsiCo, Inc., the Royal Crown Cola Co. and Seven-Up, Inc. ILSI insists that the NutraSweet Co. carries no special weight despiteits U.S. monopoly on the sweetener. "The NutraSweet Co. is one of ourmembers," said ILSI administrator Sharon Senzik. "Committees operate byRobertís Rules of Order." Filer collaborated for several years on NutraSweet research with acolleague at the University of Iowa, Dr. Lewis Stegink. Filer pledgedthat, despite his past ties to the company, as ILSIís head he would "letthe chips fall where they may" on research results. Samuel Molinary, co-chairman of ILSIís panel, is Searle's former director of scientificaffairs and now Pepsicoís research director. Molinary insists that ILSIis not a "lacky and tool" of the NutraSweet Co. Peter Dews, a Harvard University psychobiology professor named toILSIís original board of trustees in 1978, has served as an ILSIconsultant since then. Dews recently took the trouble to write andpromote an article declaring that, based on scientific presentations atan ILSI aspartame conference in Spain last year, "there is now a mass ofevidence" that NutraSweet is safe if consumed at FDA-recommended levels. Dews declined to discuss his ILSI consulting fees, except to say it is"not enough to make any difference in my life." ILSIís 1984 return filedwith the Internal Revenue Service showed payments to Dews that year of$31,000. A lawyer for the ILSI pledged to the IRS in obtaining tax-exempt statusfor the foundation in 1983, that the organization "does not have anyplans to engage in commercially sponsored scientific research." AttorneyRoger Middlekauff advised the IRS that ILSI would "direct the researchtoward benefiting the public" and would release all research results. But Elsas charged that ILSI "is definitely a front organization to tryto make the public believe that there is some non-directed, non-biasedresearch going on," when ILSI studies actually are likely to supportNutraSweetís safety. The industry has invited scientific critics for paid visits to companylaboratories, sometimes offering courtesy "honorariums," an industrysource said. The NutraSweet Co. also hosted critics at conferences in resortsettings. Matalon briefed ILSI on his research at the meeting in theCosta del Sol region on Spainís southern coast. In the summer of 1985, the firm flew Wurtman, Elsas, Matalon,Pardridge, several of their wives and other NutraSweet critics to a two-day meeting at a luxurious home in Northeast Harbor, Maine. An afternoonwas spent on a yacht, participants said. "This was industry wooing theconcerned to shut up." Elsas said. Pardridge said he was the only strong aspartame critic to accept aninvitation in June 1986 to a heavily-attended Searle sponsoredconference at a picturesque ski resort in Keystone, Colo. Pardridge saidwhen he tried during the conference to raise his concerns aboutphenylalanine, the discussion was cut off. "It was just another typicalindustry whitewash," he said.
UPI REPORT PART 3:Part 3:Sweet Corporate Victoriesby: Gre...
UPI REPORT PART 3:
Part 3:Sweet Corporate Victoriesby: Gregory Gordon WASHINGTON (UPI) In October 1982, Sen. Howell Heflin, D-Ala, proposedan obscure amendment altering the laws covering U.S. patent extensions,a move affecting only one company and one product, the artificialsweetener, aspartame. Without mentioning aspartame, which is sold under the name NutraSweet,the senate passed the amendment to the Orphan Drug Act, extending G.D.Searle Co.ís domestic monopoly on aspartame sales for another fiveyears, 10 months, and 17 days. "We think itís an excellent amendment," remarked Sen. Orrin Hatch, R-Utah, wrapping up a five-minute discussion on the Senate floor. When the House approved the same language a month later, it all butcinched another $3.5 billion to $4 billion in revenues for the Chicago-based, Searle. It helped Searleís stockholders sell the companyís assets, includingits lucrative NutraSweet division and the two domestic use patents, for$2.7 billion to the Monsanto Corp. in the summer of 1985. Sponsors of the measure found their campaign committee, enriched. Heflinís 1984 reelection committee received contributions totaling atleast $9,000. from Searleís top officers and its political actioncommittee, more than any others among a long list of Searlebeneficiaries in Congress, federal Election Committee records show. Hatchís committee received at least $3,000. the records show. Heflin defended his sponsorship of the measure, saying Searle had beenvictimized by regulatory delays that ate up most of its 17-year patent. But a spokesman for the U.S. Patent Office said Heflinís legislationmarked one of only a handful of instances in the last three decades inwhich a companyís patent has been extended by a private bill inCongress. It also provided a glimpse of the adeptness with which Searle,Monsanto, and their lobbyists have guided the artificial sweetenerthrough the obstacles of government regulatory bureaucracies to capturebig financial rewards. Headed by Donald Rumsfeld, the former Ford White House Chief of Staff,Searle repeatedly demonstrated its political acumen on other front, too,in the years prior to the sale to Monsanto. In 1981, the company overcame a controversy-snarled, eight year reviewprocess to win Food and Drug Administration approval for NutraSweet.In 1984, Searle parried an assault on the sweetenerís safety fromArizona food scientist, Dr. Woodrow Monte after hiring Arizona Gov.Bruce Babbittís former chief of staff as a lobbyist. Searle officerspassed along campaign contributions of $2,000. to a key lawmaker, andthe company soon had won passage of legislation crushing Monteís effortsto force tough state restrictions on the sweetener. "I don't know of any company that has apparently covered all of itsbases as well as has Searle," said Sen. Metzenbaum (D-Ohio). "Whether ithas to do with the scientists or lawyers, or non-profit institutions, oruniversities, or whatever; in every instance, I have found that theyhave expended their dollars very carefully and very wisely, but withoutapparent restraint as to the amount." Indeed, besides Searleís hiring of up to a dozen lobbyists, UPI tracednearly $200,000. in federal campaign contributions between 1973 and 1986from its officers and political action committee. The political intervention in the patent process drew the ire ofseveral small companies seeking to enter the aspartame market,triggering charges that a corporate giant benefited from unjustified orpreferential treatment. "I think its obvious they (Searle officials) used political muscle,"Alan Kligerman, president of Lactaid, Inc., a New Jersey diet foodmanufacturer, said of the patent extension. He said his firm had beeninterested in manufacturing aspartame until the patent was extended, but"Searle was well wired in." "It is possible that they (the Senate) did not know what they werepassing," he said. "I don't know how they got that through, except withthe right phone calls." "I would not hesitate to say," Metzenbaum said, "that the manner inwhich that five-year extension of the patent rights was put through onthe floor of the U.S. Senate was totally inappropriate." "It should not have been without the entire body being advised that,that issue was going to be on the floor of the Senate." Metzenbaum said that the Senate has an "alert" system under which alllegislation is cleared with individual senators before it is brought tothe floor, but the system was bypassed. Jerry Ray, a spokesman for Heflin, asserted the offices of keysenators, including Metzenbaum, approved the measure before it went tothe floor. But Ray offered no explanation for the failure to fullydisclose the contents and impact of the measure. Ray quoted Heflin, Chairman of the Senate Ethics Committee, is sayingSearle representatives never mentioned campaign contributions in askinghim to sponsor the amendment. Heflin said he has "supported all patent restoration bills" becauseregulatory delays have created "a chronic problem" in which companiesget so little use out of their 17-year patents, they are reluctant toput money into research. Heflin said, in Searleís case, "almost 35 percent of the patent termhad been used on a long series of administrative hearings, trials, andappeals (in) which, in the end, the corporation finally prevailed. Tonot restore some of the patent term lost would unfairly penalize them." G.D. Searle sought an extension of its patent on grounds that the Foodand Drug Administrationís handling of its aspartame approval petitionwas "an unparalleled instance of unnecessary regulatory delay, whichworked a great injustice to Searle". Critics argue that, to the contrary, the FDA suspended its 1974approval allowing Searle to market the sweetener because of evidence thecompanyís animal studies were flawed and the results were misrepresentedto the FDA in the early 1970's. The evidence prompted FDA chief counsel Richard Merrill to ask the U.S.Attorneyís office in Chicago to open a grand jury investigation intopossible fraud by the company. While a grand jury investigated similarallegations related to Searle drug products, no such inquiry was everbegun into the aspartame testing. But the FDA was concerned enough aboutSearleís research to appoint two task forces, a university researchgroup, and a Public Board of Inquiry to review various studies. In 1981, shortly after taking office, FDA commissioner Arthur HullHayes, Jr. overturned the three-man Board of Inquiry and approved saleof NutraSweet in dry foods. Two years later, Hayesí deputy, MarkNovitch, approved the use of aspartame in soft drinks. Kligerman dismissed as "crap" Searleís contention it had beenvictimized by the FDA bureaucracy, which delayed a decision from 1975 to1981. "The FDA had reason for doing this," Kligerman said of the intensereview process. "It was not an unnecessary delay. It was Searleís faultthis happened." For Purification Engineering, Inc. of Columbia, Md., which raised moneyfrom private investors and built a plant solely to manufacture aspartamefor Searle, the congressional action ultimately turned out to bedevastating. Gary Calton, a senior vice president for Purification Engineering, saidthat on Jan. 4, 1985, Searle notified the firm its contract would not berenewed. Seven months later, the firm was sold to Rhone-Poulenc Co., aFrench firm. "My company would have been worth a great deal more if it had not beenfor that (patent) extension," Calton said. (Note: Searle sold TheNutraSweet Co. to Monsanto in 1985) Calling the action unfair, he said,"I don't think Congress should go around passing laws making G.D. Searlerich any more than they should go around making me rich." Searle officials declined to discussed the patent extension, but acompany lobbyist, former White House official William Timmons, said thecompany "felt there was an injustice" in the delays followingaspartameís 1974 approval. He said the company "took an advocacy role bytalking to a lot of members of Congress". In May of 1984, FEC records show Heflinís reelection committee received$1,000. donations from Daniel Searle, the chief executive officer of thegiant pharmaceutical company; his wife, Dain; William Searle, Searleísbrother who was a company director; William Searleís wife, Sally;Suzanne Searle Dixon, a sister of the Searles; and her husband, WesleyDixon, who also was a company director. Heflin also received $1,000. from William Searle prior to the generalelection, and $2,000. in Searle PAC contributions, FEC records show. On November 1982, a week after his reelection and a month afterpraising the amendment in the Senate chambers, Hatchís committeereceived $2,000. in contributions from top Searle officers, the recordsshow. Sen. Robert Byrd (D-W.Va.), who brought the amendment up for a vote onHeflinís behalf, also received a $1,000. campaign contribution fromDaniel Searle on Sept. 25, 1981. Hatch received contributions of $1,000. each from Daniel Searle, WesleyDixon, and William Searle on Nov. 11, 1982, days after he was reelectedto a second term in which he continued as chairman of the Labor andHuman Resources Committee that oversees the FDA. As chairman of the panel until last January, Hatch repeatedly blockedSen. Metzenbaumís calls for new hearings into the safety of NutraSweet. Prior to his reelection, Hatch also received $2,500. in contributionsfrom the soft drink PAC. Rep. Henry Waxman (D-Calif.), who sponsored the Orphan Drug Actcovering research for treating rare diseases and who carried Hefliníspatent amendment to the bill in the House, received $1,500. in campaigncontributions from the soft drink PAC, including $500. two days beforethe measureís introduction in the House. Like Heflin, Waxman made no mention of aspartame in describing theSenate amendments to the drug act on the House floor. Searle also flashed its political prowess after Arizona scientistWoodrow Monte stirred up a furor in 1984 by publicly assailingNutraSweetís safety. The ensuing events, Monte charged, "reflected exactly what Searle hasbeen doing all along. Theyíve been buying their way into the hearts andminds of America. They've been using their financial acumen to get theirway." Within months, legislative rules were swept aside one day in early 1985and, in a swift, subtle maneuver without notice to the public, Monteíscampaign for state regulations on the sweetener was sidetracked. Monte was a leading national advocate in the drive to block marketingof NutraSweet until his own credibility was damaged in 1984 withdisclosures he had invested in "put options" that would have earnedprofits if Searleís stock dropped.He now concedes his options trading was a mistake, but denies itinfluenced his research. Monte said he was convinced in 1983, when the FDA okayed use ofNutraSweet in carbonated beverages, that the sweetener would break downinto poisonous quantities of methyl alcohol in diet sodas left in theSouthwest sun. Monte, director of the Food Science and Nutrition Laboratories atArizona State, and two consumer groups petitioned the Arizona Dept. ofHealth Services to ban the sweetener. Monte said his rat studies had shown that chronic ingestion of methylalcohol causes brain damage similar to that in humans suffering fromMultiple Sclerosis, including seizures, amnesia, optic neuritis,numbness, and dizziness. In the desert heat, Monte said, methanoldegrades faster into toxic methyl alcohol. Searle and FDA officials have argued that aspartame contains too littlemethanol to pose a health hazard. When Monte and the consumer groups pressed their legal challenge formore than a year, Searle flexed its muscle: The company dispatched acoterie of lobbyists to the state capitol, among them Andrew Hurwitz,Gov. Babbittís former Chief of Staff; prominent Arizona lobbyist CharlesPine; company lawyer Roger Thies, and another company official, DavidWest. Between August 23, and Sept. 21, 1984 company officers Daniel Searleand his brother-in-law, Wesley Dixon, each contributed $1,000. to thecampaign of State House Majority Leader Burton Barr, later a GOPcandidate for governor, reports to the Arizona Secretary of Stateísoffice records show. Campaign disclosure forms show revealed that, during the same period,several House Republicans received contributions from the Committee toreelect Barr, including State Reps. Don Aldridge, Karen Mills, and JanBrewer, all among the Health Committee members who voted 13-0 to passthe measure affecting NutraSweet. The trio received $1,500., $1,000. and$750. respectively from Barr, who for years has enhanced his influenceby donating to colleaguesí campaigns. Barr and Arizona State University Regent William Reilly contacted theschoolís president, J. Russell Nelson, and Academic Vice President JackKinsinger to inquire into Monteís public attacks on NutraSweet,published reports said. Kinsinger insisted that the issue caused nodelay in his decision to grant Monte tenure. Barr did not return phonecalls. When Monteís first petition was rejected and he filed forreconsideration, Hurwitz wrote a letter offering legal advice to theDept. of Health Services (DHS) about its response, and sent copies toBarr and aides to Gov. Babbitt. In April of 1985, about the same time Monte and his associates finallywere to be granted a hearing before the state agency on their petition,they learned that the Arizona Legislature had used a rare maneuver tochange the law, without public notice to bar state regulation of FDA-approved food additives. The measure passed under the misleading titleof a toxic waste bill.Monteís campaign to ban NutraSweet in Arizona prompted the State Dept.of Health Services to conduct a study to determine how much NutraSweetsoft drinks degraded in high-temperature conditions. The study,completed in July 1984, found that methanol levels were highest (9.4ppm), in Diet 7-Up samples stored the longest time in the warmesttemperature, 99? F heat. Present and former Arizona state officials have told UPI that the studyconcerned DHS officials enough that they discussed a NutraSweet ban. But Norman Peterson, manager of the DHSís Office of Chronic Disease andEnvironmental Health Services, said that the agency concluded that "theFDA address the methyl alcohol question and had all sorts of supportingdata. We had no basis for saying that the data they had presented insupport was not correct or adequate." Another source said Peterson was distressed enough that, during ameeting attended by DHS director Donald Mathis, he proposed beingallowed to recommend that pregnant woman, and children, limit theirconsumption of NutraSweet.Peterson would not confirm the episode, but recalled that he "was upsetabout the fact that there were so many unanswered questions". Mathis, who since left the agency, said he was satisfied that it"wouldn't be humanly possible" to ingest levels of NutraSweet that wouldproduce a toxic reaction. In September 1984, Monte and his associates file suit to force the DHSto impose storage and labeling requirements or ban NutraSweetaltogether. But a proposed settlement under which the agency would holda public hearing was scuttled because it lacked the approval of Mathisísuccessor, Lloyd Novick. After more negotiations, the DHS agreed to hold a hearing. But beforeit could take place, the issue was killed by the legislative change. House Speaker James Sossaman later admitted that the GOP-controlledHouse violated its own rules in passing a so-called "strike all"amendment. Chairman Bart Baker of the Health Committee engineered theaction, in which an existing bill was stripped, replaced with theNutraSweet language and brought to a vote without the required 24 hourspublic notice. For Monte, the development was all the more staggering after he hadgotten into a jam over his stock purchase. Monte said that, afterreviewing files at the FDA and consulting with his lawyer in 1983, heinvested less than $2,000. on Searle options, hoping to raise money tosupport his costly legal battles against the sweetener. He said he endedup losing $1,224. Lawyer Rick Faerber also invested in part, he said, because of Monteísknowledge of an upcoming CBS story critical of the FDAís approval ofaspartame. He said stock analysts had phoned Monte inquiring about hisArizona petitions and apparently got the idea the developments woulddepress the stock value. Faerber said he regrets telling Monte that he "didnít think there wasanything wrong" with investing, particularly because pro-NutraSweetforces apparently learned of their dealings. CBS employees also bought"put options" but a Securities and Exchange Commission investigation didnot lead to any charges. Shortly after news stories about the investment appeared, Rep. BobMcEwen, (R-Ohio), assailed CBS and Monte for "irresponsible reportingand conflicts of interest" in a brief speech on the floor of the U.S.Senate. McEwen charged that the "false report" about NutraSweet wasaired solely for profit. But in his speech, Rep. McEwen did not mention that his top assistantCharles Greener, is the son of William Greener, Jr., Searleís vicepresident for corporate communications.Charles Greener who said he was "unaware" of Rep. McEwenís floor speechuntil after it occurred, said his father never has handled NutraSweetmatters and that McEwen did not know any Searle officials. The success of the Searle family business, founded 80 years ago, is allthe more astounding when compared to the companyís predicament in 1977when it plucked Rumsfeld as its president. Facing a company mired indebt, Rumsfeld, a native Chicagoan and former Illinois congressman,quickly hired three other outgoing Ford Administration officials to joinhim. As executive vice president, he named John Robson, a former partner inthe law firm of Sidley & Austin who had served as President Fordíschairman of the Civil Aeronautics Board. Robert Shapiro, Robsonísspecial assistant at the Transportation Department, was tapped asgeneral counsel. Rumsfeld also hired William Greener, Sr., who had beena spokesman in the Ford White House and Rumsfeldís chief spokesman atthe Pentagon. The pharmaceutical company suddenly was being run by lawyers andpoliticians.Stomaching a $28 million net loss in his first year, Rumsfeld slashedSearleís operations, selling off more than 30 subsidiaries worth morethan $400 million. Before Rumsfeld could mount a full scale effort to lift a FDA freeze onthe sale of NutraSweet, Searle was hit with serious new problems. Suitsfiled on behalf of 780 women, alleged the companyís Copper 7intrauterine device had caused them to develop pelvic inflammatorydisease, an infection of the reproductive tract that can lead tosterility, even death. Before the suits could be settled, Searle sold out to Monsanto. The huge, St. Louis-based chemical company and its officers werepromptly met with stockholder suits alleging they had failed to explorepotential safety problems with Searleís biggest moneymakers- Copper 7IUD and NutraSweet. Rejecting criticism of the acquisition, Earl Harbison, Jr., executivevice president of Monsanto and Chairman of the Board of its Searlepharmaceutical subsidiary, said in October 1985, that Monsanto "studiedthis situation (Copper 7 litigation) very closely prior to acquiringSearle, including consultations with independent physicians"."We satisfied ourselves with the safety and efficacy of the product," hesaid.Since then, Copper 7 has been pulled off the market. Some lawyerslikened the resulting legal morass to the failure of the Dalkon Shieldthat drove the Richmond-based A.H. Robins Co. into Chapter 11 bankruptcyprotection. But a former Monsanto official, who requested anonymity, said that aspart of the sale agreement, Searle set aside reserves to cover the IUDlawsuits. Thanks to NutraSweet, Searle family members Daniel and WilliamSearle and their sister, Suzanne Searle Dixon, to date appear to havewalked away unscathed from all the crises and legal battles. And even if NutraSweet were proved hazardous, the purchase agreementprovided "no escrow, reserve or holdback for liability stemming from thepotential health hazards attributed to the NutraSweet product line,"says one lawsuit filed by Chicago lawyer Robert Holstein on behalf of aMonsanto stockholder. And Rumsfeld emerged from his nine years with the company in solidfinancial condition. Securities and Exchange Commission records showthat for his guiding the sweeping turnaround, he earned more than $ 2million in salaries and more than $1.5 million in bonuses between 1979and 1984. "Banana plants don't make NutraSweet," the television announcer notedwryly, and the image of an exotic bird perched in a jungle tree filledthe screen. "Neither do cows," said the voice, as the camera cut to a robust-looking heifer wagging its tail. "But they might as well. If you've hadbananas and milk, you've eaten whatís in NutraSweet." True, bananas, milk and NutraSweet all contain phenylalanine, one of 21amino acids that form the "building blocks" of protein. But that doesníttell the whole story. Dr. Richard Wurtman, a neuroscientist at theMassachusetts Institute of Technology, says that because NutraSweetlacks other important amino acids normally found in foods, the brainabsorbs unusually high levels of phenylalanine that could increase thelikelihood of epileptic seizures. Referring to an ad proclaiming that the body treats the ingredient ofthe artificial sweetener "no differently than if they came from a peachor a string bean or a glass of milk," Wurtman said, "Thatís not true." Dr. Louis Elsas, director of medical genetics at Emory University,groans at the industry arguments that eating or drinking NutraSweet(aspartame) is just like eating a hamburger. "Phenylalanine is a known toxin to the brain,í Elsas said. "Aspartameis phenylalanine, and drinking aspartame is like drinking phenylalanineas an individual amino acid." A spokeswoman at the New York offices of Ogilvy and Mather, the lead adagency on the sweetener account for the Chicago-based NutraSweet Co.,declined comment on the allegation. The drumbeat of NutraSweetadvertisements has been steady. Beverage Industry, a trade publication,labeled the NutraSweet blitz "probably the largest advertising campaignever designed around a product ingredient." Industry sources say that since 1984, The NutraSweet Co. alone hasspent $30 million to $40 million a year on advertising, and ads by dietsoft drink manufacturers and other companies, whoís products carry theswirl trademark of the sugar-free sweetener, would easily send that thefigure past $100 million a year. The campaign has worked to make NutraSweet a household word.Football stars Joe Montana and Dan Marino and boxer Marvin Hagler havepitched products containing the artificial sweetener on television.Former Democratic vice presidential candidate Geraldine Ferraro hasappeared in advertisements endorsing a product containing NutraSweet, ashave numerous celebrities, including Bill Cosby, Raquel Welch and BillyCrystal.
UPI Aspartame Report Greg Gordon Part 3I
GREG GORDON, UPI INVESTIGATIVE REPORT ON ASPARTAME 10/87:
Part One of Three:
UPI Investigative Report 1987
NutraSweet:Questions Swirl
Part 1: DID SEARLE IGNORE EARLY WARNING SIGNS ?
By GREGORY GORDON
WASHINGTON (UPI) ≠ A University of Illinois scientist says he warned
the G.D.Searle Co. years before NutraSweet swept the diet food and soft
drink markets that the companyís new artificial sweetener could heighten
risks of brain damage in fetuses and small children.
Dr. Reuben Matalon, a pediatrician and geneticist, said that between
1976 and 1984, he prodded Searle officials several times to do more
research on the issue, but Searle never performed the studies suggested.
The Chicago-based company did, however, pursue U.S. government approval
for the low-calorie sugar substitute, and got it in a controversial
ruling in 1981.
Today, tens of millions of Americans guzzle diet soft drinks stamped
with the NutraSweet "Swirl", dump packets of the NutraSweet tabletop
sweetener, "Equal" in their coffee and consume NutraSweet-flavored
cereal, puddings, gelatins, cheesecake, chewing gum or vitamin tablets.
The Food and Drug Administration, despite receiving more than 3,600
consumer complaints, is so confident of the sweeteners safety that it
recently expanded uses to frozen and chilled fruit juices.
Matalon, however, has remained skeptical. In May, he reported that his
initial, federally funded tests on 51 adults suggests heavy NutraSweet
consumption may increase blood levels of a key amino acid enough to
affect attention span, memory and concentration in some people,
particularly small children. Pregnant women who are sensitive to the
sweetenerís main component, the amino acid phenylalanine, also may face
heightened risk that their infants will have birth defects, Matalon
said.
More than a dozen other scientists, some of whom are conducting
clinical studies, also say they suspect that subtle effects of the sweet
powder could pose a major health problem. They believe NutraSweet ≠
known generically as aspartame, is linked to brain damage, epileptic
seizures, eyesight problems, allergic reactions, headaches or dizziness.
"The likelihood is very strong that aspartame does produce serious and
potentially damaging brain effects in a number of people", said Richard
Wurtman, a neuroscientist at the Massachusetts Institute of Technology
who is studying scores of people who suffered seizures after using
NutraSweet.
Facing continuing controversy, The NutraSweet Co., the name adopted by
Searleís NutraSweet Division following its 1985 sale to the giant
Monsanto Co., vouches for the sweetener.
The firmís president, Robert Shapiro, rejects criticism voiced by
Matalon and others, saying, "The fact is that the world scientific
community has considered these very specific allegations repeatedly, and
has come to the same conclusion as the FDA."
An eight-month United Press International investigation not only turned
up scientific concerns, but also raised questions about the way the
product was approved, about the independence and depth of the industry-
funded research efforts into its safety, and about "revolving door"
relationships between FDA officials including former FDA commissioner
Arthur Hull Hayes Jr. and the food and drink industries.
Shapiro, who obtained an advance copy of this UPI report, said, "Taken
as a whole, the effect of the article is likely to be a thoroughly
misleading impression of the state of knowledge of the subject." Company
spokesman Thym Smith said the firm is contemplating litigation.
Senator Howard Metzenbaum, D-Ohio, a leading skeptic of the FDAís
approval who plans to hold a hearing on NutraSweet in the next few
weeks, said, "I don't have hard evidence that the product is not safe.
But, I am convinced that there is no hard evidence...that the product is
safe."
FDA officials stress they have yet to see hard data disproving the
sweeteners safety. For that reason, the agency last year rejected a
consumer groupís petition to ban it on grounds that 140 users suffered
seizures and eye problems.
NutraSweet has been at the center of intense controversy almost since
July 18, 1981, the day Hayes approved its use in dry foods. Indeed, in
rendering his decision, Hayes overrode six of the nine scientists on two
agency review panels who felt studies on itís possible links to brain
tumors in rats has been inadequate.
Since then, some independent scientists have become unusually
outspoken.
Drs. Louis Elsas of Emory University and William Pardridge of the UCLA
Medical School charged that the diet food and drink industry has engaged
in a "whitewash" by rejecting health concerns, manipulating research
studies and wining and dining scientific critics.
These and other researchers describe a world of subtle, high-stakes
strategy in which the availability of corporate funds and the design of
research protocols may have influenced the course of a multibillion-
dollar industry and potentially affected the safety of millions of
people.
The NutraSweet Co. and a non-profit industry group reject these
allegations, asserting they have commissioned scores of studies to test
the product's safety and that decisions on research funding are made
solely on merit. Company spokesman Smith said NutraSweetís "phenomenal
safety record is the result of the well known nature of the product
rather than manipulations of management." Consumer complaints about
NutraSweet surged in 1983, after Hayesí deputy, Mark Novitch, with the
commissioners support, approved its use in soft drinks such as "Diet
Coke" and "Crystal Light", sending consumption soaring.
UCLAís Pardridge noted in a letter to the American Medical Association
Journal last year that, with aspartame, the food industry now is adding
about five million pounds of phenylalanine ≠ "a known neurotoxin" to the
food supply every year.
Roy Burry, an analyst with Kidder-Peabody, Inc., said the exploding
diet market now accounts for 24 percent of soft drink sales, compared
with 10 percent in the 1970ís, and is growing at 20 to 25 percent a
year.
The NutraSweet Co.ís sales are no longer public, but last year revenues
were believed to have exceeded previously stated levels of $700 million.
So intense has been the NutraSweet advertising campaign that the diet
food and beverage industry created a "NutraSweet World Professional
Figure Skating Championship."
"Taking good care of oneself makes life a little better- and NutraSweet
makes it a little sweeter!" boasted one ad during a TV fitness program.
The NutraSweet Co. also has paid up to $3 million a year for a 100-
person public relations effort by the Chicago offices of Burson,
Marsteller, a former employee of the New York PR firm said. The employee
said Burson Marsteller has hired numerous scientists and physicians,
often at $1,000 a day, to defend the sweetener in media interviews and
other public forums. Burson Marsteller declines to discuss such matters.
Dismissing safety fears, The NutraSweet Co. stresses that its product,
which in raw form, is 180 times sweeter than sugar, has been endorsed by
the AMA and other scientific bodies worldwide. Actually, the AMAís
Council of Scientific Affairs gave a qualified endorsement based on
"available evidence", including company-funded studies that were
challenged by FDA task forces during investigations of the firmís
laboratory practices in the 1970ís.
Of 69 scientists who responded to a recent General Accounting Office
survey, 28 said they felt more research was needed on NutraSweet and a
dozen of those questioned considered it a major health problem.
An "aspartame victims" group has formed, a consumer group has pressed
legal challenges and the company faces at least three personal injury
suits. In one suit, Jim Stoddard, 32, a diabetic in Grand Rapids,
Michigan, charged that his heavy NutraSweet consumption triggered a
dozen seizures-the last one so violent he dislocated his shoulder and
fractured his collar bone.
Stoddardís lawyer, and his sister, Cynthia, alleged he suffered brain
damage and now has trouble understanding words because he consumed a
product inadequately tested by Searle. She said she withdrew the suit
recently for tactical reasons but would refile it early next year. The
company denies the allegations.
Wurtman, who quit his job as a Searle consultant and became a vocal
NutraSweet opponent, said he has been contacted by more than 200 persons
who suspect they suffered seizures as a result of NutraSweet use.
He said Dr. Gerald Gaull, a Searle vice president, visited his
laboratory in 1985 and threatened to veto funding by ILSI(International
Life Sciences Institute), the Washington-based tax-exempt foundation,
for his planned study into whether NutraSweet changes brain chemistry,
lowering some humansí seizure thresholds.
Gaull said, "thereís no way" Searle, with one of 12 votes on the ILSI
panel, could veto a grant decision, but he did not deny making the
threat.
ILSI ultimately turned away Wurtman on grounds that Searle already had
arranged for seizure studies at Yale University and New Yorkís Mount
Sinai Hospital ≠ studies that have drawn criticism because human
volunteers were given aspartame only once or twice.
Wurtman said he is now tapping his laboratoryís budget, which is
extremely limited, slowing progress on his own studies. "Aspartame may
be a serious health hazard," he said, "Itís critically important that
high quality research now be done to assess this hazard." In his letter
to the AMA Journal, Pardridge said no one has fully researched the
degree to which aspartame raises phenylalanine levels on the brain and,
if so, what the possible effects are. He said in an interview, after he
raised questions about the sweetenerís effects on children, that ILSI
rejected his two grant proposals in 1985. Last year, he said, Gaull
pressed him at a conference in Colorado to prove that phenylalanine, one
of twenty-one amino acids, causes brain damage.
"It was incredible for him to ask that," Pardridge said. "That was the
basis for my ILSI grant (proposal)."
"Thereís an internal conflict of interest," he said, "when a company,
which has profit at the bottom line, is charged with finding out the
true safety of its product."
Elsas, who publicly assailed NutraSweet in 1985, said he was put off
for a year before ILSI rejected his proposal without stating a reason.
ILSIís executive director, Jack Filer, asserted research proposals were
rejected because they cost too much or lacked scientific merit.
While denying funding for these aspartame skeptics, the company
(G.D.Searle/NutraSweet Co.) and ILSI have financed researchers with whom
they have long-running relationships. A number of industry-funded
scientists acknowledged that company and ILSI officials originated ideas
for their studies or participated in the research design. These studies
generally have reported the sweetener is safe.
Consumer lawyer Turner said, "The notion that an industrial company
would take large sums of money and parcel it out to scientific
consulting firms and university departments, who they consider to be
personal and commercial allies is an unconscionable way to ensure the
safety of the American food supply."
He said the NutraSweet experience shows that "the entire system of the
way scientific research is done needs to be carefully investigated,
evaluated, and revamped."
Food industry officials also said most studies financed by Searle or
the NutraSweet Co. have been arranged as contracts, rather than grants.
Smith said the company often uses contracts "to accomplish a specific
research task."
James Scala, former director of health sciences for the General Foods
Corp., a major NutraSweet user, said that a scientist working under
contract became "more of an arm of the Searle research group than a
grantee."
Scala, now with the Shaklee Corp., also said that most early NutraSweet
research consisted of short-term studies that ignored possible "subtle,"
long-term effects.
Matalon said, "Let us say cigarettes were invented today, and you give
20 people two packs a day and after six weeks, no one has cancer, would
you say that it was safe? Thatís what they did with NutraSweet."
Dr. Martha Freeman, who was a medical officer at the FDAís Bureau of
Drugs in the early 1970ís, argued in 1973 that the substance (aspartame)
was "a new chemical...that doesn't occur naturally" and should only be
approved after long-term clinical studies, as if it were a new drug. Her
arguments were rejected.
Despite these complaints, the NutraSweet Co. has insisted that the
company-funded studies prove that except for people with the rare
disease, phenylketonuria, the human body processes phenylalanine in
aspartame just like any other food, Thomas Stenzel, a spokesman for the
International Food Information Council, a public relations arm for
NutraSweetís manufacturers and biggest customers, contended scientific
adversaries comprise a small minority.
He said he found it "very important that the leading professional
health organizations" have found NutraSweet to be safe.
For example, the American Academy of Pediatrics concluded in 1985 that
studies on people given massive aspartame doses showed no dangerous rise
in blood phenylalanine levels; the Epilepsy Institute has reported the
sweetener "to be safe for people with epilepsy."
Filer, executive director of the industryís main organ, the
International Life Sciences Institute, suggested that problems blamed on
aspartame may stem from "water load" on the brain resulting from over-
consumption of liquids.
Maj. Michael Collings, who was an Air Force F-16 pilot in top physical
condition, said he often drank up to a gallon of aspartame-sweetened
products when he finished his daily, five-to-eight mile jogs in Nevadaís
desert heat. After noticing slight trembling in his hands over several
weeks, he collapsed unconscious with a seizure on Oct.4, 1985, a lawyer
for Collings said.
Because of the seizure, Collings is grounded as a pilot for life, is on
medication and was ordered transferred to Maxwell Air Force Base in
Alabama at a $400-a-month pay reduction, said attorney Bryan Gould, who
charged in a state court suit last year that NutraSweet caused the
seizure.
"He tells me thereís no way to describe the feeling of flight," Gould
said. "He loves to fly and now he can't." The NutraSweet Co. denies any
link between the sweetener and Collings medical problems.
FDA officials, while publicly endorsing aspartame, are watching the
situation closely. In late 1985, the agency took the unusual step of
asking doctors nationwide to report adverse reactions to NutraSweet, and
another food additive, sulfites ≠ a move normally reserved for drugs.
Sulfites since have been banned from the market. A FDA spokesman said
about 25 doctors filed reports suggesting aspartame links to varying
health problems.
The FDA approved NutraSweet products on the condition they carry a
compulsory warning to phenylketonurics, individuals sensitive to its
phenylalanine component. But Matalon, Elsas and others worry about
millions of "carriers" of the disease who are unaware of their
sensitivity. They say NutraSweet could damage fetuses of pregnant women
whose bodies have trouble processing the amino acid.
Matalon, on releasing his new study, urged that products be labeled
with the amount of NutraSweet they contain so consumers can monitor
their intake. In Canada, aspartame is the only food additive for which
such quantity food labeling is required.
With consumption soaring, Sanford Miller, chief of FDAís Bureau of
Foods, has acknowledged considering a labeling requirement in this
country.
Dr. Gary Flamm, the FDAís top toxicologist overseeing food additives,
said that beyond labeling, once a food additive such as NutraSweet has
won approval, it is far more difficult to restrict its marketing.
"If...our approval of it was a mistake, we couldn't rectify that
without data showing that aspartame was unsafe," said Flamm, an
aspartame defender.
Even then, he said, the agency would face a new regulatory thicket
unless it could be shown NutraSweet posed "an imminent hazard." Consumer lawyer James Turner, who has campaigned for more than a decade for a
NutraSweet ban, assailed the FDAís treatment of such safety issues.
"Once a product is on the market, whether there by nefarious or honest
means," he said, "it is impossible to get it off the market until it has
caused severe, undeniable damage that has probably lasted over many
years."
Several independent scientists have alleged that the industry has
steered research money to allies in the scientific community, while
denying funding to those who have raised health concerns.
A number of scientists who pressed for more studies into possible brain
damage told UPI they were turned away by Searle and the International
Life Sciences Institute, a tax-exempt industry foundation supported by
the company, its Japanese aspartame-manufacturing partner and 10 sellers
of NutraSweet-flavored products.
In interviews, Drs. Matalon, Wurtman, Elsas, Pardridge, and John Olney
of Washington University in Illinois charged that the industry has paid
millions of dollars for studies that have skirted the real issues about
NutraSweet.
"There are virtually no studies," Turner said, "that have been done by
individuals using resources other than the industryís that have given a
clean bill of health to aspartame."
University of Illinois researcher Matalon recalled that he couldnít
persuade Searle to do the kind of research necessary to put to rest
lingering health concerns, neither on his first approach in 1976 nor
when he submitted specific grant proposals to more four more company
officials beginning in late 1980.
After NutraSweet won FDA approval and began changing the dietary habits
of millions of Americans, Matalon said he lost patience in 1984 with the
usual encouragement from Searle officials about prospects for future
funding. "I felt they were just stringing me along," said Matalon, who
obtained a $180,000 grant from the National Institutes of Health.
Company spokesman Smith said the NutraSweet manufacturer has "not
discouraged Dr. Matalonís work, nor anyone elseís." While declining to
comment on the decision not to fund Matalonís study, Smith said the
company spends "between $30 million and $35 million annually on
research."
"We do make decisions based on how we understand a study will be
conducted and, reasonable scientists may disagree on study designs," he
said.
The company has alleged that a number of its critics are seeking to
pressure the industry to fund their laboratories.
Faced with sharply differing opinions on the sweetenerís safety, the
FDA and the National Institutes of Health, the governmentís chief
funding mechanism for private research, have financed few studies on its
effects. One former ranking NIH official, Artemis Simopoulos, argued the
agency "should have a very extensive program on aspartame so people
would know" whether it is safe.
Yet some NIH scientists have served as consultants to the ILSI
foundation, helping decide the awards of $500,000 in annual NutraSweet
research grants in recent years. Even Simopoulos was a non-paid member
of the foundationís board.
But ILSIís "aspartame technical committee," consisting of the
NutraSweet Co. and 11 other manufacturers and users of sweetener, have
been accused of discriminating against NutraSweet critics in granting
awards.
Represented on the ILSI committee are General Foods, the Coca Cola Co.,
PepsiCo, Inc., the Royal Crown Cola Co. and Seven-Up, Inc.
ILSI insists that the NutraSweet Co. carries no special weight despite
its U.S. monopoly on the sweetener. "The NutraSweet Co. is one of our
members," said ILSI administrator Sharon Senzik. "Committees operate by
Robertís Rules of Order."
Filer collaborated for several years on NutraSweet research with a
colleague at the University of Iowa, Dr. Lewis Stegink. Filer pledged
that, despite his past ties to the company, as ILSIís head he would "let
the chips fall where they may" on research results. Samuel Molinary, co-
chairman of ILSIís panel, is Searle's former director of scientific
affairs and now Pepsicoís research director. Molinary insists that ILSI
is not a "lacky and tool" of the NutraSweet Co.
Peter Dews, a Harvard University psychobiology professor named to
ILSIís original board of trustees in 1978, has served as an ILSI
consultant since then. Dews recently took the trouble to write and
promote an article declaring that, based on scientific presentations at
an ILSI aspartame conference in Spain last year, "there is now a mass of
evidence" that NutraSweet is safe if consumed at FDA-recommended levels.
Dews declined to discuss his ILSI consulting fees, except to say it is
"not enough to make any difference in my life." ILSIís 1984 return filed
with the Internal Revenue Service showed payments to Dews that year of
$31,000.
A lawyer for the ILSI pledged to the IRS in obtaining tax-exempt status
for the foundation in 1983, that the organization "does not have any
plans to engage in commercially sponsored scientific research." Attorney
Roger Middlekauff advised the IRS that ILSI would "direct the research
toward benefiting the public" and would release all research results.
But Elsas charged that ILSI "is definitely a front organization to try
to make the public believe that there is some non-directed, non-biased
research going on," when ILSI studies actually are likely to support
NutraSweetís safety.
The industry has invited scientific critics for paid visits to company
laboratories, sometimes offering courtesy "honorariums," an industry
source said.
The NutraSweet Co. also hosted critics at conferences in resort
settings. Matalon briefed ILSI on his research at the meeting in the
Costa del Sol region on Spainís southern coast.
In the summer of 1985, the firm flew Wurtman, Elsas, Matalon,
Pardridge, several of their wives and other NutraSweet critics to a two-
day meeting at a luxurious home in Northeast Harbor, Maine. An afternoon
was spent on a yacht, participants said. "This was industry wooing the
concerned to shut up." Elsas said.
Pardridge said he was the only strong aspartame critic to accept an
invitation in June 1986 to a heavily-attended Searle sponsored
conference at a picturesque ski resort in Keystone, Colo. Pardridge said
when he tried during the conference to raise his concerns about
phenylalanine, the discussion was cut off. "It was just another typical
industry whitewash," he said.
Part One of Three:
UPI Investigative Report 1987
NutraSweet:Questions Swirl
Part 1: DID SEARLE IGNORE EARLY WARNING SIGNS ?
By GREGORY GORDON
WASHINGTON (UPI) ≠ A University of Illinois scientist says he warned
the G.D.Searle Co. years before NutraSweet swept the diet food and soft
drink markets that the companyís new artificial sweetener could heighten
risks of brain damage in fetuses and small children.
Dr. Reuben Matalon, a pediatrician and geneticist, said that between
1976 and 1984, he prodded Searle officials several times to do more
research on the issue, but Searle never performed the studies suggested.
The Chicago-based company did, however, pursue U.S. government approval
for the low-calorie sugar substitute, and got it in a controversial
ruling in 1981.
Today, tens of millions of Americans guzzle diet soft drinks stamped
with the NutraSweet "Swirl", dump packets of the NutraSweet tabletop
sweetener, "Equal" in their coffee and consume NutraSweet-flavored
cereal, puddings, gelatins, cheesecake, chewing gum or vitamin tablets.
The Food and Drug Administration, despite receiving more than 3,600
consumer complaints, is so confident of the sweeteners safety that it
recently expanded uses to frozen and chilled fruit juices.
Matalon, however, has remained skeptical. In May, he reported that his
initial, federally funded tests on 51 adults suggests heavy NutraSweet
consumption may increase blood levels of a key amino acid enough to
affect attention span, memory and concentration in some people,
particularly small children. Pregnant women who are sensitive to the
sweetenerís main component, the amino acid phenylalanine, also may face
heightened risk that their infants will have birth defects, Matalon
said.
More than a dozen other scientists, some of whom are conducting
clinical studies, also say they suspect that subtle effects of the sweet
powder could pose a major health problem. They believe NutraSweet ≠
known generically as aspartame, is linked to brain damage, epileptic
seizures, eyesight problems, allergic reactions, headaches or dizziness.
"The likelihood is very strong that aspartame does produce serious and
potentially damaging brain effects in a number of people", said Richard
Wurtman, a neuroscientist at the Massachusetts Institute of Technology
who is studying scores of people who suffered seizures after using
NutraSweet.
Facing continuing controversy, The NutraSweet Co., the name adopted by
Searleís NutraSweet Division following its 1985 sale to the giant
Monsanto Co., vouches for the sweetener.
The firmís president, Robert Shapiro, rejects criticism voiced by
Matalon and others, saying, "The fact is that the world scientific
community has considered these very specific allegations repeatedly, and
has come to the same conclusion as the FDA."
An eight-month United Press International investigation not only turned
up scientific concerns, but also raised questions about the way the
product was approved, about the independence and depth of the industry-
funded research efforts into its safety, and about "revolving door"
relationships between FDA officials including former FDA commissioner
Arthur Hull Hayes Jr. and the food and drink industries.
Shapiro, who obtained an advance copy of this UPI report, said, "Taken
as a whole, the effect of the article is likely to be a thoroughly
misleading impression of the state of knowledge of the subject." Company
spokesman Thym Smith said the firm is contemplating litigation.
Senator Howard Metzenbaum, D-Ohio, a leading skeptic of the FDAís
approval who plans to hold a hearing on NutraSweet in the next few
weeks, said, "I don't have hard evidence that the product is not safe.
But, I am convinced that there is no hard evidence...that the product is
safe."
FDA officials stress they have yet to see hard data disproving the
sweeteners safety. For that reason, the agency last year rejected a
consumer groupís petition to ban it on grounds that 140 users suffered
seizures and eye problems.
NutraSweet has been at the center of intense controversy almost since
July 18, 1981, the day Hayes approved its use in dry foods. Indeed, in
rendering his decision, Hayes overrode six of the nine scientists on two
agency review panels who felt studies on itís possible links to brain
tumors in rats has been inadequate.
Since then, some independent scientists have become unusually
outspoken.
Drs. Louis Elsas of Emory University and William Pardridge of the UCLA
Medical School charged that the diet food and drink industry has engaged
in a "whitewash" by rejecting health concerns, manipulating research
studies and wining and dining scientific critics.
These and other researchers describe a world of subtle, high-stakes
strategy in which the availability of corporate funds and the design of
research protocols may have influenced the course of a multibillion-
dollar industry and potentially affected the safety of millions of
people.
The NutraSweet Co. and a non-profit industry group reject these
allegations, asserting they have commissioned scores of studies to test
the product's safety and that decisions on research funding are made
solely on merit. Company spokesman Smith said NutraSweetís "phenomenal
safety record is the result of the well known nature of the product
rather than manipulations of management." Consumer complaints about
NutraSweet surged in 1983, after Hayesí deputy, Mark Novitch, with the
commissioners support, approved its use in soft drinks such as "Diet
Coke" and "Crystal Light", sending consumption soaring.
UCLAís Pardridge noted in a letter to the American Medical Association
Journal last year that, with aspartame, the food industry now is adding
about five million pounds of phenylalanine ≠ "a known neurotoxin" to the
food supply every year.
Roy Burry, an analyst with Kidder-Peabody, Inc., said the exploding
diet market now accounts for 24 percent of soft drink sales, compared
with 10 percent in the 1970ís, and is growing at 20 to 25 percent a
year.
The NutraSweet Co.ís sales are no longer public, but last year revenues
were believed to have exceeded previously stated levels of $700 million.
So intense has been the NutraSweet advertising campaign that the diet
food and beverage industry created a "NutraSweet World Professional
Figure Skating Championship."
"Taking good care of oneself makes life a little better- and NutraSweet
makes it a little sweeter!" boasted one ad during a TV fitness program.
The NutraSweet Co. also has paid up to $3 million a year for a 100-
person public relations effort by the Chicago offices of Burson,
Marsteller, a former employee of the New York PR firm said. The employee
said Burson Marsteller has hired numerous scientists and physicians,
often at $1,000 a day, to defend the sweetener in media interviews and
other public forums. Burson Marsteller declines to discuss such matters.
Dismissing safety fears, The NutraSweet Co. stresses that its product,
which in raw form, is 180 times sweeter than sugar, has been endorsed by
the AMA and other scientific bodies worldwide. Actually, the AMAís
Council of Scientific Affairs gave a qualified endorsement based on
"available evidence", including company-funded studies that were
challenged by FDA task forces during investigations of the firmís
laboratory practices in the 1970ís.
Of 69 scientists who responded to a recent General Accounting Office
survey, 28 said they felt more research was needed on NutraSweet and a
dozen of those questioned considered it a major health problem.
An "aspartame victims" group has formed, a consumer group has pressed
legal challenges and the company faces at least three personal injury
suits. In one suit, Jim Stoddard, 32, a diabetic in Grand Rapids,
Michigan, charged that his heavy NutraSweet consumption triggered a
dozen seizures-the last one so violent he dislocated his shoulder and
fractured his collar bone.
Stoddardís lawyer, and his sister, Cynthia, alleged he suffered brain
damage and now has trouble understanding words because he consumed a
product inadequately tested by Searle. She said she withdrew the suit
recently for tactical reasons but would refile it early next year. The
company denies the allegations.
Wurtman, who quit his job as a Searle consultant and became a vocal
NutraSweet opponent, said he has been contacted by more than 200 persons
who suspect they suffered seizures as a result of NutraSweet use.
He said Dr. Gerald Gaull, a Searle vice president, visited his
laboratory in 1985 and threatened to veto funding by ILSI(International
Life Sciences Institute), the Washington-based tax-exempt foundation,
for his planned study into whether NutraSweet changes brain chemistry,
lowering some humansí seizure thresholds.
Gaull said, "thereís no way" Searle, with one of 12 votes on the ILSI
panel, could veto a grant decision, but he did not deny making the
threat.
ILSI ultimately turned away Wurtman on grounds that Searle already had
arranged for seizure studies at Yale University and New Yorkís Mount
Sinai Hospital ≠ studies that have drawn criticism because human
volunteers were given aspartame only once or twice.
Wurtman said he is now tapping his laboratoryís budget, which is
extremely limited, slowing progress on his own studies. "Aspartame may
be a serious health hazard," he said, "Itís critically important that
high quality research now be done to assess this hazard." In his letter
to the AMA Journal, Pardridge said no one has fully researched the
degree to which aspartame raises phenylalanine levels on the brain and,
if so, what the possible effects are. He said in an interview, after he
raised questions about the sweetenerís effects on children, that ILSI
rejected his two grant proposals in 1985. Last year, he said, Gaull
pressed him at a conference in Colorado to prove that phenylalanine, one
of twenty-one amino acids, causes brain damage.
"It was incredible for him to ask that," Pardridge said. "That was the
basis for my ILSI grant (proposal)."
"Thereís an internal conflict of interest," he said, "when a company,
which has profit at the bottom line, is charged with finding out the
true safety of its product."
Elsas, who publicly assailed NutraSweet in 1985, said he was put off
for a year before ILSI rejected his proposal without stating a reason.
ILSIís executive director, Jack Filer, asserted research proposals were
rejected because they cost too much or lacked scientific merit.
While denying funding for these aspartame skeptics, the company
(G.D.Searle/NutraSweet Co.) and ILSI have financed researchers with whom
they have long-running relationships. A number of industry-funded
scientists acknowledged that company and ILSI officials originated ideas
for their studies or participated in the research design. These studies
generally have reported the sweetener is safe.
Consumer lawyer Turner said, "The notion that an industrial company
would take large sums of money and parcel it out to scientific
consulting firms and university departments, who they consider to be
personal and commercial allies is an unconscionable way to ensure the
safety of the American food supply."
He said the NutraSweet experience shows that "the entire system of the
way scientific research is done needs to be carefully investigated,
evaluated, and revamped."
Food industry officials also said most studies financed by Searle or
the NutraSweet Co. have been arranged as contracts, rather than grants.
Smith said the company often uses contracts "to accomplish a specific
research task."
James Scala, former director of health sciences for the General Foods
Corp., a major NutraSweet user, said that a scientist working under
contract became "more of an arm of the Searle research group than a
grantee."
Scala, now with the Shaklee Corp., also said that most early NutraSweet
research consisted of short-term studies that ignored possible "subtle,"
long-term effects.
Matalon said, "Let us say cigarettes were invented today, and you give
20 people two packs a day and after six weeks, no one has cancer, would
you say that it was safe? Thatís what they did with NutraSweet."
Dr. Martha Freeman, who was a medical officer at the FDAís Bureau of
Drugs in the early 1970ís, argued in 1973 that the substance (aspartame)
was "a new chemical...that doesn't occur naturally" and should only be
approved after long-term clinical studies, as if it were a new drug. Her
arguments were rejected.
Despite these complaints, the NutraSweet Co. has insisted that the
company-funded studies prove that except for people with the rare
disease, phenylketonuria, the human body processes phenylalanine in
aspartame just like any other food, Thomas Stenzel, a spokesman for the
International Food Information Council, a public relations arm for
NutraSweetís manufacturers and biggest customers, contended scientific
adversaries comprise a small minority.
He said he found it "very important that the leading professional
health organizations" have found NutraSweet to be safe.
For example, the American Academy of Pediatrics concluded in 1985 that
studies on people given massive aspartame doses showed no dangerous rise
in blood phenylalanine levels; the Epilepsy Institute has reported the
sweetener "to be safe for people with epilepsy."
Filer, executive director of the industryís main organ, the
International Life Sciences Institute, suggested that problems blamed on
aspartame may stem from "water load" on the brain resulting from over-
consumption of liquids.
Maj. Michael Collings, who was an Air Force F-16 pilot in top physical
condition, said he often drank up to a gallon of aspartame-sweetened
products when he finished his daily, five-to-eight mile jogs in Nevadaís
desert heat. After noticing slight trembling in his hands over several
weeks, he collapsed unconscious with a seizure on Oct.4, 1985, a lawyer
for Collings said.
Because of the seizure, Collings is grounded as a pilot for life, is on
medication and was ordered transferred to Maxwell Air Force Base in
Alabama at a $400-a-month pay reduction, said attorney Bryan Gould, who
charged in a state court suit last year that NutraSweet caused the
seizure.
"He tells me thereís no way to describe the feeling of flight," Gould
said. "He loves to fly and now he can't." The NutraSweet Co. denies any
link between the sweetener and Collings medical problems.
FDA officials, while publicly endorsing aspartame, are watching the
situation closely. In late 1985, the agency took the unusual step of
asking doctors nationwide to report adverse reactions to NutraSweet, and
another food additive, sulfites ≠ a move normally reserved for drugs.
Sulfites since have been banned from the market. A FDA spokesman said
about 25 doctors filed reports suggesting aspartame links to varying
health problems.
The FDA approved NutraSweet products on the condition they carry a
compulsory warning to phenylketonurics, individuals sensitive to its
phenylalanine component. But Matalon, Elsas and others worry about
millions of "carriers" of the disease who are unaware of their
sensitivity. They say NutraSweet could damage fetuses of pregnant women
whose bodies have trouble processing the amino acid.
Matalon, on releasing his new study, urged that products be labeled
with the amount of NutraSweet they contain so consumers can monitor
their intake. In Canada, aspartame is the only food additive for which
such quantity food labeling is required.
With consumption soaring, Sanford Miller, chief of FDAís Bureau of
Foods, has acknowledged considering a labeling requirement in this
country.
Dr. Gary Flamm, the FDAís top toxicologist overseeing food additives,
said that beyond labeling, once a food additive such as NutraSweet has
won approval, it is far more difficult to restrict its marketing.
"If...our approval of it was a mistake, we couldn't rectify that
without data showing that aspartame was unsafe," said Flamm, an
aspartame defender.
Even then, he said, the agency would face a new regulatory thicket
unless it could be shown NutraSweet posed "an imminent hazard." Consumer lawyer James Turner, who has campaigned for more than a decade for a
NutraSweet ban, assailed the FDAís treatment of such safety issues.
"Once a product is on the market, whether there by nefarious or honest
means," he said, "it is impossible to get it off the market until it has
caused severe, undeniable damage that has probably lasted over many
years."
Several independent scientists have alleged that the industry has
steered research money to allies in the scientific community, while
denying funding to those who have raised health concerns.
A number of scientists who pressed for more studies into possible brain
damage told UPI they were turned away by Searle and the International
Life Sciences Institute, a tax-exempt industry foundation supported by
the company, its Japanese aspartame-manufacturing partner and 10 sellers
of NutraSweet-flavored products.
In interviews, Drs. Matalon, Wurtman, Elsas, Pardridge, and John Olney
of Washington University in Illinois charged that the industry has paid
millions of dollars for studies that have skirted the real issues about
NutraSweet.
"There are virtually no studies," Turner said, "that have been done by
individuals using resources other than the industryís that have given a
clean bill of health to aspartame."
University of Illinois researcher Matalon recalled that he couldnít
persuade Searle to do the kind of research necessary to put to rest
lingering health concerns, neither on his first approach in 1976 nor
when he submitted specific grant proposals to more four more company
officials beginning in late 1980.
After NutraSweet won FDA approval and began changing the dietary habits
of millions of Americans, Matalon said he lost patience in 1984 with the
usual encouragement from Searle officials about prospects for future
funding. "I felt they were just stringing me along," said Matalon, who
obtained a $180,000 grant from the National Institutes of Health.
Company spokesman Smith said the NutraSweet manufacturer has "not
discouraged Dr. Matalonís work, nor anyone elseís." While declining to
comment on the decision not to fund Matalonís study, Smith said the
company spends "between $30 million and $35 million annually on
research."
"We do make decisions based on how we understand a study will be
conducted and, reasonable scientists may disagree on study designs," he
said.
The company has alleged that a number of its critics are seeking to
pressure the industry to fund their laboratories.
Faced with sharply differing opinions on the sweetenerís safety, the
FDA and the National Institutes of Health, the governmentís chief
funding mechanism for private research, have financed few studies on its
effects. One former ranking NIH official, Artemis Simopoulos, argued the
agency "should have a very extensive program on aspartame so people
would know" whether it is safe.
Yet some NIH scientists have served as consultants to the ILSI
foundation, helping decide the awards of $500,000 in annual NutraSweet
research grants in recent years. Even Simopoulos was a non-paid member
of the foundationís board.
But ILSIís "aspartame technical committee," consisting of the
NutraSweet Co. and 11 other manufacturers and users of sweetener, have
been accused of discriminating against NutraSweet critics in granting
awards.
Represented on the ILSI committee are General Foods, the Coca Cola Co.,
PepsiCo, Inc., the Royal Crown Cola Co. and Seven-Up, Inc.
ILSI insists that the NutraSweet Co. carries no special weight despite
its U.S. monopoly on the sweetener. "The NutraSweet Co. is one of our
members," said ILSI administrator Sharon Senzik. "Committees operate by
Robertís Rules of Order."
Filer collaborated for several years on NutraSweet research with a
colleague at the University of Iowa, Dr. Lewis Stegink. Filer pledged
that, despite his past ties to the company, as ILSIís head he would "let
the chips fall where they may" on research results. Samuel Molinary, co-
chairman of ILSIís panel, is Searle's former director of scientific
affairs and now Pepsicoís research director. Molinary insists that ILSI
is not a "lacky and tool" of the NutraSweet Co.
Peter Dews, a Harvard University psychobiology professor named to
ILSIís original board of trustees in 1978, has served as an ILSI
consultant since then. Dews recently took the trouble to write and
promote an article declaring that, based on scientific presentations at
an ILSI aspartame conference in Spain last year, "there is now a mass of
evidence" that NutraSweet is safe if consumed at FDA-recommended levels.
Dews declined to discuss his ILSI consulting fees, except to say it is
"not enough to make any difference in my life." ILSIís 1984 return filed
with the Internal Revenue Service showed payments to Dews that year of
$31,000.
A lawyer for the ILSI pledged to the IRS in obtaining tax-exempt status
for the foundation in 1983, that the organization "does not have any
plans to engage in commercially sponsored scientific research." Attorney
Roger Middlekauff advised the IRS that ILSI would "direct the research
toward benefiting the public" and would release all research results.
But Elsas charged that ILSI "is definitely a front organization to try
to make the public believe that there is some non-directed, non-biased
research going on," when ILSI studies actually are likely to support
NutraSweetís safety.
The industry has invited scientific critics for paid visits to company
laboratories, sometimes offering courtesy "honorariums," an industry
source said.
The NutraSweet Co. also hosted critics at conferences in resort
settings. Matalon briefed ILSI on his research at the meeting in the
Costa del Sol region on Spainís southern coast.
In the summer of 1985, the firm flew Wurtman, Elsas, Matalon,
Pardridge, several of their wives and other NutraSweet critics to a two-
day meeting at a luxurious home in Northeast Harbor, Maine. An afternoon
was spent on a yacht, participants said. "This was industry wooing the
concerned to shut up." Elsas said.
Pardridge said he was the only strong aspartame critic to accept an
invitation in June 1986 to a heavily-attended Searle sponsored
conference at a picturesque ski resort in Keystone, Colo. Pardridge said
when he tried during the conference to raise his concerns about
phenylalanine, the discussion was cut off. "It was just another typical
industry whitewash," he said.
UPI Aspartame Report Greg Gordon Part 3I
UPI REPORT PART 2:
UPI Investigative Report: 10-07-87
Seizure, Blindness victims point to NutraSweet
By GREGORY GORDON
WASHINGTON (UPI) Susan Yarmey, a free-lance writer from Quincy,
Mass., awoke on a hot July morning in 1984 with a large bump on her head
and bruises all over her body.
"I had no recollection of what happened. There were marks on the wall,
two wooden steps were broken and there was a nice gash on the wall where
my head hit," she said.
Yarmeyís doctors diagnosed her injuries as resulting from a "classic"
epileptic seizure. She and Massachusetts Institute of Technology
neuroscientist Richard Wurtman believe the incident may be connected to
her consumption of the artificial sweetener, NutraSweet, know
generically as aspartame.
"A friend in New York directed me to the possible effects of NutraSweet
consumption...I was probably, at that particular time period, doing a
liter and a half to two liters (of diet soda with NutraSweet) a day,"
said Yarmey, who said when she stopped taking NutraSweet her problems
disappeared.
Yarmey is not alone. Many NutraSweet consumers, particularly heavy
users, who have suffered headaches, tremors, blindness, allergic
reactions and seizures, blame NutraSweet for their ailments.
Wurtman says he personally is aware of more than 200 cases in which he
suspects NutraSweet has caused health problems such as headaches,
dizziness, and seizures.
Wurtman says the problem might be solved simply by stiffening the
labeling requirements for NutraSweet products so that certain identified
groups can monitor their intake.
"The groups I would identify are pregnant ladies, small children, people
with a history of seizures and people who are taking certain drugs that
interact with phenylalanine," an amino acid in the sweetener, Wurtman
said.
Another former NutraSweet consumer, Shannon Roth, a mother of two who
works as a goldsmith in Ocala, Florida, organized Aspartame Victims and
Their Friends, Inc. after suffering blindness in one eye. She said the
group now has about 700 members.
"I got up in the morning and had two packs (of Equal, the NutraSweet
tabletop version) in each cup of coffee...three or four cups of coffee
before noon. Then I'd switch to the iced tea with it," Roth said.
In the summer of 1984, Roth said, she began to experience headaches,
sleep and memory loss, and irritability.
After getting out of bed one morning, she discovered she couldn't see
when she closed her right eye, Roth said. "I could see like through a
black veil. It was like a centralized, almond-shaped black spot," she
said.
Doctorsí laboratory tests failed to trace the cause of her partial
blindness, she said, and one doctor told her not to expect vision to
return to her eye.
Roth said she suspected NutraSweet as the cause after learning of a
similar case that was allegedly linked to the sweetener, and after about
four weeks without NutraSweet, her headaches and other problems ceased.
Her sight began to return a few weeks later, she said.
Joyce Wilson, a real estate agent in Stockbridge, Georgia, said she
began suffering from high blood pressure, dizziness and other ill
effects in 1982 after using Equal in her coffee and eating NutraSweet-
flavored puddings. She said that in 1984 and 1985, she lost some vision.
"I'm not blaming this all on NutraSweet," Wilson said. "I'm just saying
itís a strange coincidence that when I started using it, I started
falling apart."
Dr. Morgan Raiford, an ophthalmologist at Emory University examined
both Roth and Wilson and believes their problems stem from consumption
of the methyl alcohol in NutraSweet.
Dorris Bookhart, 43, a legal secretary in Lodge, S. Carolina, started
having what were later diagnosed as temporal lobe seizures in August of
1984. At the time, she said, she was drinking four 16-ounce bottles of
Diet Coke a day, as well as diet lemonade. Both contained NutraSweet.
In January of 1985, after six months of problems, she suffered a grand
mal seizure, a convulsive episode in which the victim loses
consciousness, she said. Her doctors were mystified by the seizures, but
they ruled out epilepsy, Bookhart said.
She said she suspected NutraSweet as the culprit when, at her husbandís
suggestion, she stopped drinking Diet Coke and the problems ended.
"I've cried a lot of times thinking these people have destroyed my life
and there isn't a damn thing I can do," she said.
Another heavy user of the artificial sweetener, Larry Taylor of
Arlington, Texas, said he was hospitalized for five or six days to
undergo a battery of tests after suffering a grand mal seizure in 1985.
He was also a victim of migraine headaches that became more frequent
between 1982 and 1984. After his seizures, Taylor, an anesthetist, was
not allowed to work until January of this year (1987), a disability he
said left him "financially devastated."
---------
What critics say about NutraSweet
By GREGORY GORDON =
WASHINGTON (UPI) ≠ Despite the NutraSweet Co.ís insistence that scores
of company studies have "proved" the sweetener is harmless, hereís a
sampling of concerns from a hard core of scientific critics:
What the critics say about NutraSweet
Dr. Rueben Matalon of the University of Illinois has reported that
heavy consumption of NutraSweetís main component ≠ the amino acid
phenylalanine ≠ may cause neurological problems such as loss of memory
and concentration. Matalon and Dr. Louis Elsas of Emory University say
they fear aspartame consumption by some pregnant women can cause
irreversible brain damage in fetuses. They worry most about women among
an estimated 4 million to 20 million Americans who are carriers of the
genetic disease, phenylketonuria ≠ characterized by the liverís
inability to process phenylalanine. While there are an estimated 20,000
to 30,000 PKU victims nationwide who are warned not to take NutraSweet,
carriers or heterozygotes, do not have the disease and generally are
unaware of their sensitivity, they said. The company has said that the
Food and Drug Administration concluded, "NutraSweet did not present any
additional health risk to pregnant women."
Dr. Paul Spiers, a clinical neuropsychologist at Bostonís Beth Israel
Hospital, found in a recent pilot study that, after consuming
NutraSweet, some subjects with no previous problems failed to show the
usual improvement in performance on cognitive tests. He plans further
research. But Dr, Harris Lieberman of the Massachusetts Institute of
Technology, who has received industry funding for NutraSweet research in
the past, said his study of 20 adult males indicates that aspartame "has
no measurable effect on mood and performance in normal humans."
In St. Louis, Washington University allergist, Dr. Anthony Kulczycki
found that two women given NutraSweet capsules and a placebo suffered
allergic reactions to NutraSweet. The women reported hives and other
skin reactions after using the sweetener.
Dr. Donald Johns, a neurology resident at Massachusetts General
Hospital, reported last year that a "double-blind" study of a woman
suffering migraine headaches showed her problems were aggravated by
consumption of NutraSweet. NutraSweet, known generically as aspartame,
consists of phenylalanine and another amino acid, aspartic acid, linked
to a small quantity of methyl alcohol. Scientific critics seem to worry
most about phenyalanine.
Dr. Richard Wurtman, Massachusetts Institute of Technology
neuroscientist, says heavy NutraSweet consumption may so flood the
bloodstream with phenyalanine that other essential amino acids are
blocked from reaching the brain, causing chemical changes that can
affect behavior and lower the threshold at which many suffer epileptic
seizures. Wurtman and Dr. Donald Schomer of Harvard University are
testing seizure victims who used NutraSweet, particularly some whose
bodies may have trouble processing phenylalanine. The NutraSweet Co.
concedes aspartame raises phenylalanine levels, but says no harm
results, and that consuming the amino acids in NutraSweet "is just like
eating other foods containing the same protein components."
Another Wurtmen protege, Dr. Timothy Maher of Massachusetts General
Hospital, supported his mentor by reporting that mice, given a seizure
inducing drug and NutraSweet, suffered more seizures than those
receiving the drug alone. Dr. Henry Haigler, a scientist in a NutraSweet
Co. sister firm, said his similar study showed "no effect on seizure
thresholds."
Dr. William Pardridge of the UCLA Medical School, who also has done
phenylalanine research, said he most fears the sweetenerís effect on
children, who, he says, "are more likely to approach the FDAís
acceptable daily intake level of 50 milligrams per kilogram of body
weight. If youíre a child, seven to twelve years of age, the chances are
good you'll have five servings a day" ≠ close to the acceptable level,
he said. But Dr. Harvey Levy, head of the PKU clinic at Bostonís
Childrenís Hospital, wrote the Journal of the American Medical
Association that Pardridge made an "inaccurate interpretation" of their
data in predicting brain damage effects on fetuses from aspartame. Any
danger level, they said, "would seem to be considerably higher" than
levels from NutraSweet consumption.
Dr. Woodrow Monte, an Arizona State University food scientist, and Dr.
Morgan Raiford, an ophthalmology professor at Emory, worry that a
NutraSweet breakdown product, methyl alcohol, could produce severe eye
damage. Last year, Raiford examined more than a half dozen persons who
said they suffered eye problems after consuming NutraSweet heavily. He
said he diagnosed some cases of optic nerve damage and suspects
NutraSweetís methyl alcohol is the culprit. The company denies any
connection between NutraSweet and eye problems and has offered exams to
consumers who complain of such problems.
Dr. Sidney Wolfe, executive director of the Washington-based Health
Research Group, said, "The thing thatís really worrisome is that it
clearly affects brain metabolism in animals, and anyone who disputes
that is irresponsible."
Dr. John Olney of Washington University expresses fears about brain
tumors ≠ a problem he and other scientists say would not show up in
humans for 20 years and would be difficult to trace to NutraSweet. Olney
said Searle rat studies have shown conflicting brain tumor data. As
early as 1971, Olney reported that aspartic acid in aspartame killed
cells in the brainís hypothalamus region, which regulates glandular and
hormonal functions.
----------
The NutraSweet Company responds to UPI series.
WASHINGTON (UPI) ≠ In response to the United Press International series
of articles on NutraSweet, The NutraSweet Co. issued the following
statement:
A series of articles to be released this week by UPI seriously
misrepresents the vast body of scientific evidence, which establishes
the safety of aspartame.
Contrary to the impression created by these articles, the scientific
record has been carefully reviewed by independent and official
scientific and regulatory agencies around the world.
Without exception, each of these agencies has concluded that aspartame
is a safe sweetener which can be used as a normal part of the daily
diet. The following quotations are representative of expert scientific
and medical opinion around the world.
U.S. Food and Drug Administration: "The data and information supporting
the safety of aspartame are extensive. It is likely that no food product
has ever been so closely examined for safety...Few compounds have
withstood such detailed testing and repeated close scrutiny, and the
process through which aspartame has gone should provide the public with
additional confidence of its safety."
American Medical Association Council on Scientific Affairs:
"Consumption of aspartame of normal humans is safe..."
American Diabetes Association: "Aspartame has been determined to be
safe for the general population as well as for people with diabetes."
Government of Canada (Health Protection Branch): "Aspartame is one of
the most extensively studied chemicals permitted for use in food...Based
on the available data it has been concluded that aspartame would not
pose a hazard to health when used in accordance with the current
provisions of the Canadian food and drug regulations."
Government of Denmark (Danish Food Institute): "Research published in
the scientific literature and/or studied in detail by governments and
independent scientific committees maintains that the use of aspartame as
an additive does not bear any health risk at all...There is, therefore,
no toxicological basis for believing the intake of aspartame is soft
drinks and food products should give rise to harmful effects in children
or adults, even people with high level usage."
Government of Great Britain (UK Committee on Toxicity of Chemicals and
Food): "Following detailed consideration of all toxicological data, we
see no objection to the use of aspartame in food."
Other scientific agencies that have reviewed the evidence and confirmed
the safety of aspartame include the World health Organization of the
United Nations; the Scientific Committee on Foods of the European Common
Market; the Epilepsy Institute; and the American Academy of Pediatrics.
Aspartame has been reviewed and approved as a safe sweetener by the
official food regulatory authorities in all the leading nations of the
world, including many which forbid or restrict the usage of other
sweeteners.
A recent article by Harvard Medical School Prof. Peter Dews reviewed
the "massive evidence" that establishes the safety of aspartame. Dr.
Dews concluded: "Many articles of everyday consumption that are known to
be safe might not survive the scrutiny of such intensive and continued
investigation."
The respected consumer publication Consumer Reports summarized its
conclusions this way: "An objective weighing of the evidence suggests
that aspartame is the artificial sweetener to be preferred on safety
grounds."
The UPI articles also seek to discredit the process by which aspartame
was reviewed and approved by the FDA.
These charges have been conclusively rebutted by both the FDA, itself,
and by the General Accounting Office, the investigative agency of the
Congress. A full GAO report on the approval process concluded that the
FDA had properly followed the appropriate procedures and had adequately
addressed the scientific issues.
The UPI series is replete with misstatements and distortions, which
convey a totally misleading impression of the scientific facts. Any
concern or anxiety by consumers who read these articles is absolutely
unwarranted. Aspartame is safe as approved by FDA and regulatory
authorities around the world. Any contrary impression created by UPI
articles is a serious disservice to the public.
PART 2:
(Editorís Note: UPI investigative reporter Gregory Gordon spent eight
months examining industry research into the popular artificial sweetener
NutraSweet and the Food and Drug Administrationís handling of the
product permeating the diet food and drink markets. here is the second
in his three-part series.)
PART 2: NUTRASWEET APPROVAL MARRED BY CONTROVERSY
by: Gregory Gordon
WASHINGTON (UPI) Pouring over laboratory rat studies in the spring of
1981 in the governmentís final safety review of a new artificial
sweetener, senior statistician Satya Dubey of the Food and Drug
Administration was troubled.
Dubey, a member of a special FDA "commissionerís team" formed to help
decide the fate of the product to be known as NutraSweet, wrote an
internal memo that brain tumor data from the rat tests was so
"worrisome" that he could not recommend approval.
Two other statisticians on the six-member team agreed with Dubey that
the Chicago-based G.D. Searle Co. had not proved with "reasonable
certainty" the safety of the sweetener, known generically as aspartame.
A 1980 Public Board of Inquiry had voted 3-0 to ban aspartame because of
similar fears.
But a few weeks later on July 18, 1981, new FDA Commissioner Arthur
Hull Hayes, Jr., a pharmacologist who had been in office less than three
months and had little background in food additives, overturned the board
and approved the use of aspartame in dry foods.
The ruling, one of the first regulatory actions of the Reagan
presidency, came at a time of growing concern that the most widely used
low-calorie sweetener, saccharin, was linked to cancer. Thus Hayesí
approval of NutraSweet profoundly changed the eating habits of millions
of Americans, handing Searle a financial bonanza.
It also climaxed a topsy-turvy, eight year FDA review process in which
the agency approved the sweetener, then banned it and demanded a grand
jury investigation of its manufacturer, only to reverse course again
after reexamining the issue at least five times.
Now, six years after Hayesí ruling, its uses expanded, the sweetener is
widely consumed in diet sodas, puddings, cereal, drink mixes, and even
chewing gum and vitamins. Yet NutraSweet and its FDA approval remain at
the center of controversy, the sweetenerís safety questioned by a small
corps of independent scientists; defended by its manufacturer and the
diet food and drink industry.
In a recently released report, the General Accounting Office concluded
that the FDA "adequately followed" its food additive approval process on
NutraSweet.
Congressís investigative arm did not evaluate the sweetenerís safety. A
federal appeals court also has rejected court suits by consumer groups
challenging the NutraSweet approval.
United Press International has learned that more than 10 federal
officials involved with the NutraSweet review have taken private sector
jobs linked to the industry ≠ among them, Hayes, an acting FFDA
commissioner and former chiefs and acting chiefs of the agencyís Bureau
of Foods.
In addition, many of the scientists who have produced favorable studies
or served as outspoken advocates of NutraSweetís safety have received
grants or consulting fees from Searle and the industry.
Consumer lawyer, James Turner, who has unsuccessfully pressed petitions
for a NutraSweet ban as part of an 11 - year campaign against the
sweetener, asserted, " NutraSweet is an opportunity for the entire
country to look in great detail at how we make food safety decisions. It
is a rickety, 19th Century process."
G.D. Searle began to study the artificial sweetener aspartame soon
after a company laboratory chemist, James Schlatter, stumbled on the
compound when he licked it off his finger while conducting ulcer
research in 1965.
In a memo on Dec. 28, 1970, a Searle official laid out a plan for
winning FDA approval for the sweetener. " We must create an affirmative
atmosphere in our dealing with them," Herbert Helling wrote senior
company executives. Helling suggested that Searle representatives
carefully order proposals to the FDA to put Bureau of Foods officials
"into a yes saying habit." If FDA officials could be swayed to do Searle
some favor, he asserted, it would "help bring them into a subconscious
spirit of participation."
On July 26, 1974, just 15 months after Searle petitioned for approval,
FDA commissioner Alexander Schmidt approved aspartame use in dry foods,
allowing a 30-day period for public hearings and comment. He acted on a
strong endorsement from the Bureau of Foods, now called the Center for
Food Safety and Applied Nutrition (CFSAN).
At that point, consumer attorney Turner, author of a 1970 book about
food additives, objected to the short comment period. Turner was joined
in his protest by a now-defunct public interest group and by Dr. John
Olney, a Washington University neuropathologist who had linked aspartame
to brain lesions in mice.
Schmidt promptly froze the approval. In an action that was the first of
its kind, he ordered that a Public Board of Inquiry be named to look
into aspartame.
Schmidt also had been alerted to conflicts between Searle research
reports and conclusions from independent animal studies that the firmís
anti-infective drug, Flagyl and its cardiovascular drug Aldactone may
cause cancer. He named a Bureau of Drugs task force to investigate.
Philip Brodsky, the unitís since-retired lead investigator, said
aspartame was included in a broad inquiry into Searle animal studies on
five drugs and the Copper-7 intrauterine device to surprise the company.
"We didnít think theyíd expect us to cover it."
The task force assailed Searleís conduct of research on most of the
products, including aspartame, in a searing, 84-page report.
"At the heart of the FDAís regulatory process," the report said, "is
its ability to rely upon the integrity of the basic safety data
submitted by sponsors of regulated products. Our investigation clearly
demonstrates that, in the G.D. Searle Co., we have no basis for such
reliance now."
The task force charged, for example, that the company removed tumors
from live animals and stored animal tissues in formaldahyde for so long
that they deteriorated. Instead of performing autopsies on rhesus
monkeys that suffered seizures after being fed aspartame, the company
had financed a new monkey study with a different methodology that showed
no problems.
For the next seven years, Searleís petition was tied up in reviews by
the task force and other sharply critical FDA panels. At the task
forceís request, Richard Merrill, the FDAís general counsel, demanded in
a letter that Samuel Skinner, the U.S. attorney in Chicago, open a grand
jury investigation of Searle and three of its employees.
One Searle official named by Merrill was Robert McConnell, who had been
director of Searleís Department of Pathology and Toxicology and oversaw
most of the companyís aspartame research.
McConnellís Detroit lawyer, Gerald Wahl, said that as the inquiries
heated up, his client was suddenly awarded a $15,000. bonus and asked to
take a three-year sabbatical by director Wesley Dixon. Wahl said Dixon
told McConnell he had become a "political liability," a remark Dixon
later denied making.
McConnell received his annual salary of more than $60,000 during the
sabbatical at the Massachusetts Institute of Technology, but he never
got his job back, and ended up suing the company, Wahl said.
"I've represented hundreds of executives, but I've never seen anybody
get the deal that McConnell got," he said. "When you boil it all down,
they were looking for continued support from McConnell during the
inquiries."
Wahl said McConnell had felt pressure to hurry his research because of
the "profit motive," but the company never ordered him to alter test
results.
Chief investigator Brodsky said that "politicized" handling of the task
force disclosures, at hearings chaired by Sen. Edward Kennedy D-Mass.,
was one reason he retired in 1977. He said the main witnesses, Searle
executives, and top FDA officials uninvolved in the investigation gave
"the wrong answers to the wrong questions"ÖThey didnít even let the
experts answer the questions.
The FDA, rocked by controversy, established a set of "good laboratory
practices" ≠ minimum standards for future corporate research work.
Richard Ronk, deputy Bureau of Foods chief, stressed that Searle
practices were typical of the industry at the time, "not the worst on
the block."
Searleís fortune did not begin to change until 1977, when Donald
Rumsfeld, White House Chief of Staff under Gerald Ford, was named its
new president.
Turner alleged that Searle chose, with Rumsfeldís hiring, not to redo
the questioned studies on belief he could handle aspartame as "a legal
problem rather than a scientific problem."
The company also hired another Ford White House official, William
Timmons, as a Washington lobbyist.
Before deciding on Merrillís grand jury request, U.S. Attorney Skinner
and an aid agreed in February 1977 to meet with lawyers for Searle,
including Newton Minow, a partner in the law firm of Sidley & Austin.
A month later, Skinner, a Republican appointee who was looking for a
job as a result of Jimmy Carterís election, informed aids in a memo that
he had begun preliminary employment discussions with the law firm.
Withdrawing from the Searle matter, Skinner suggested his designated
successor, Thomas Sullivan, be left to decide whether to open a grand
jury inquiry-a move that delayed action for at least four months.
Sullivan took office just 12 weeks before expiration of the statute of
limitations for prosecuting alleged false statements on aspartame. While
the grand jury inquiry ultimately was convened, those allegations were
not explored.
Skinner denies any conflict of interest.
Assistant U.S. Attorney William Conlon worked with the grand jury until
October 12, 1977, two days after the statute of limitations expired on
the aspartame allegations. No indictments were brought on the few
matters investigated. Conlon, who declined comment, joined Sidley &
Austin 15 months later.
Following issuance of the task force report back in March 1976 and
facing a dilemma as to how to proceed, the FDA sought new reviews of
several "pivotal" studies ≠ long term animal tests to see whether
aspartame causes cancer.
A new five-member internal FDA task force analyzed three of these
studies, and Universities Associated for Research and Education in
Pathology, Inc., a consortium formed by 15 universities, was contracted
to look at another dozen.
Much like the earlier team, the five-member FDA task force, headed by
veteran Chicago inspector Jerome Bressler, assailed the quality of
animal tests into whether the substance might cause birth defects and
tumors.
The report said Searle laboratory employee Raymond Schroeder, who
worked on related research, first told investigators the feed in the
study of the aspartame breakdown product DKP (diketopiperazine) was so
inadequately mixed it appeared the rats could "discriminate" and avoid
eating the DKP.
Schroeder, who has worked for another company since 1975, later backed
off his statement. He told UPI, "I just didn't feel qualified to speak
on something I didn't work onÖThereís no one twisting my arm."
Bressler criticized the companyís "sloppiness" on all three studies.
"The question you've got to ask yourself," he said in an interview, "is:
Because of the importance of this study, why wasn't greater care taken ?
The study is highly questionable because of our findings. Why didn't
Searle, with their scientists, not closely evaluate this, knowing fully
well that the whole society, from the youngest to the elderly, from the
sick to the unsickÖwill have access to this product?"
Howard Roberts, acting director of FDAís Bureau of Foods, appointed a
five-person task force to review the Bressler teamís findings pending a
decision on whether to throw out the three tumor and birth-defect
studies.
Jacqueline Verrett, a senior scientist on the review team, said members
were barred from stating opinions about the research quality. "It was
pretty obvious that somewhere along that line they (bureau officials)
were working up to a whitewash," she said. "I seriously thought of just
walking off of that task force."
Verrett, now a private consultant, said that she and other members
wanted to "just come out and say that this whole experiment was a
disaster and should be disregarded."
But on September 28, 1977, the panel reported that deviations between
Searleís raw data and its FDA submissions were "not of such magnitude as
to alter its conclusion."
Verrett said the bureauís intent seemed to be "to tone down what was
really found." She noted the bureau felt pressure because safety
concerns also had been raised about cyclamate, another alternative for
the cancer-linked sugar substitute, saccharin.
In October, 1978, a year after ordering the review that helped get
Searleís petition back on track, Robertís (acting Director of Bureau of
Foods) quit to become vice president at the National Soft Drink
Association. The NSDAís members later marketed a stream of NutraSweet-
flavored diet soft drink products.
Reached at NSDA, Roberts dismissed Verrettís criticism, asserting the
task force report "really was of no importance." He said he had no
concerns about the appearance of his taking the NSDA job, stressing he
does not represent NSDA before the FDA. "I sleep well at night," he
said.
Negotiations for an additional, outside review of Searleís studies had
begun with an August 4, 1976 meeting between Searle and 10 FDA
officials. During the meeting, Searle officials said they desired to
help pick the consultant to perform the review, and internal FDA memo
said.
Agency memos show the FDA soon was negotiating with the Universities
Association for Research and Education in Pathology for a half-million
dollar, company-funded "validation" of a dozen Searle studies.
The pathology organizationís review concluded that Searleís studies
were authentic and the discrepancies largely inconsequential.
Adrian Gross, an investigative consultant to the 1975 task force, later
said the 16-month review was "at best, irrelevant" because the group was
limited to analyzing "whether Searle lied about the data in its tests".
"It was not our task to challenge the validity of the experimental
methods, since the FDA had itself already accepted the methodology", the
groupís executive director, Kenneth Endicott, said.
Jere Goyan, who was FDA Commissioner in 1980, said he would have put
less weight on the review than on the findings of FDAís task forces.
Goyan also suggested that, after approving aspartame in 1974, the FDAís
Bureau of Foods may have "felt they had to keep their previous
position."
Regardless, the pathology groups findings carried major weight in the
final approval decision. The chairman of the 1980 Public Board of
Inquiry, Dr. Walle Nauta of the Massachusetts Institute of Technology,
said the board had to rely on those findings because it was denied
access to the task force reports by FDA officials.
"There was absolutely no way in which we could decide who was right
here," Nauta said. "We simply had to accept the data as they stood."
Nauta was joined on the panel by Drs. Vernon Young of MIT and Peter
Lampert of the University of California at San Diego.
Before voting 3-0 to ban NutraSweet on the narrow cancer issue, the
board itself was drawn into allegations of bias because two of the three
members came from MIT ≠ as did Bureau of Foods Chief Miller and several
scientists involved in the controversy.
Between 1979 and 1982, four more FDA officials who participated in the
approval process took jobs linked to the NutraSweet industry: Pape;
acting FDA commissioner Sherwin Gardner; Albert Kolbye, who was
associate director of the Bureau of Foods for toxicology, and Mike
Taylor, an FDA lawyer who represented the bureau before the Board of
Inquiry. All four denied any conflict of interest.
After the Board of Inquiry ruled against NutraSweet on Sept. 30, 1980,
Searle waited until January 21, 1981, the day after President Reaganís
inauguration, to press for a reversal of the FDA commissioner ≠ assuring
the new administration would decide the issue.
Jere Goyan, Hayesí predecessor as commissioner, said he found the delay
curious because, after eight years of legal battles, financially
struggling Searle "obviously was most anxious to have this thing
approved."
Robert Dormer, a lawyer for the NutraSweet Co., said there was nothing
special about the Jan. 21 date or the papers filed that day.
But with Reaganís election, it was virtually assured that a republican-
appointed commissioner would replace Goyan and decide the appeal- and
Searle had strong GOP connections with Rumsfeld at the helm.
Goyan had set up a five-member "commissionerís team" of scientists with
no prior involvement in the issue to review the boardís ruling.
On May 10 and 13, 1981, a month after Hayes took office, scientists
Satya Dubey, Douglas park, and Robert Condon each laid out concerns
about the sweetenerís safety in memos to team lawyer Joseph Levitt.
Dubey not only expressed reservations about reported incidence of brain
tumors in one key Searle rat study, but also said key data in another
study appeared to have been altered. Dubey, who still works at FDA,
refuses to discuss the matter.
Condon, another statistician on the team, and Park, staff science
advisor in the agencyís Office of Health Affairs, each said the
available evidence failed to prove NutraSweetís safety or lack of
safety.
Park said that Levitt hurried the panel to decide the issue. "They
wanted to have the results yesterday," he said. "We really didnít have
time to do the in-depth review we wanted to do."
Park said Levitt met frequently with Hayes and "was obviously getting
the pressure to get a resolution and a decision made."
Sources have said the office of Sen. Howard Metzenbaum, D-Ohio, has
received allegations of political influence in Hayesí final decision-
making process.
In a letter written after the FDA cleared NutraSweet, one former Searle
saleswoman, Patty Wood-Allott, asserted the Rumsfeld told his sales
force shortly after Reagan took office that if necessary, "he would call
in his markers and that no matter what, he would see to it that
aspartame would be approved that year." Rumsfeld declined to return
phone calls.
With three of five scientists on the commissionerís team opposing
approval, it was decided to bring in a toxicologist for his opinion on
isolated issues.
Goyan said if the decision were his, he never would have enlarged the
team. While the panel did not vote, it ended up split 3-3.
Levitt, who normally would have been expected to draft an options paper
spelling out scientific evidence on key issues, took an unusual tact. He
circulated an approval recommendation ≠ and only backed off when Dubey,
Park and Condon objected, team members said.
Levitt said he was not directed to draft the approval memo, but did so
as a "tactical" step to break the teamís week-long impasse by forcing
each scientist to state his views.
"It worked didnít it?" said Levitt, who later was promoted to a post as
an executive assistant to the FDA commissioner.
One team member said that during discussions, Hayes, appeared to be
abandoning the agencyís traditional standard of "reasonable" proof of
safety and looking for "proof of hazard."
Hayesí July 1981 approval decision came in the face of a Searle threat
to file a suit challenging the regulatory delays.
His ruling relied in part on a late rat study of brain tumors submitted
by Ajinmoto, a Japanese company that manufactures aspartame for Searle.
That study, however, tested Wistar rats, a strain that some scientists
said is more tumor resistant than the Sprague-Dawley rats used in
earlier research.
In his decision, Hayes wrote: "Few compounds have withstood such
detailed testing and the repeated close scrutiny and the process through
which aspartame has gone should provide the public with confidence of
its safety."
In late 1982, Searle petitioned for FDA approval to use the sweetener
in diet soft drinks and childrenís vitamins. On a day when Hayes was
away, Novitch approved the petition, increasing the acceptable daily
intake level for humans by nearly half, from 34 mg to 50 mg per kilogram
of body weight.
Novitch, now in private industry, said he and Hayes had worked together
on the matter, but declined to say why he was left to sign the approval.
Just weeks later, Hayes resigned under the cloud of an internal Dept. of
Health and Human Services investigation into his acceptance of
gratuities from FDA-regulated companies ≠ including free rides aboard
jets owned by a major NutraSweet user, the General Foods Corp.
Shortly after being named Dean of the New York Medical school, Hayes
also became a consultant to the New York-based public relations firm of
Burson-Marsteller, which represents the NutraSweet Co. and several major
users.
Hayesí former top spokesman, Wayne Pines, who previously had joined the
firm, said he approached Hayes because he thought him "an added value"
to clients.
Hayes, now president of the E.M. Pharmaceutical Co. in Hawthorne, N.Y.,
declined comment for this series of articles. He has in the past denied
any impropriety in his consulting role, which sources said paid him more
than $1000. per day.
Burson-Marsteller vice president, Buck Buchwald stressed that Hayes was
not involved in NutraSweet issues and worked but 10 to 15 days a year.
But a former Burson-Marsteller employee, who requested anonymity, said
Hayes was hired precisely because of his decision on NutraSweet and
other issues affecting company clients.
Sen. Metzenbaum said it was "at the very leastÖunbecoming, at the very
most, it probably was inappropriate" for Hayes to accept the position.
In July 1986, Anthony Brunetti, a FDA consumer product officer who
drafted the 1983 notice approving NutraSweet use in soft drinks, also
took an industry job, joining the soft drink association as a science
advisor. Brunetti said he cleared the move with the FDAís ethics
officer.
"My situation," he said, "is no different than many, many peopleÖthat
go through the revolving door. It can be made to look like there is some
duplicity going on. In terms of my own conscious, I have no problem."
Ron Lorentzen, an FDA toxicologist who was asked by current Bureau of
Foods chief Sanford Miller to perform a separate, internal review of the
agencyís handling of aspartame, described it as a "tortured" story.
But despite the myriad questions and revolving door issues, he asserted
the FDA responded to each issue "in a way, perfectly reasonable." Other
questions have arisen over the company and industryís funding of
researchers who have invariably supported NutraSweetís safety ≠ with the
exception of people with the rare disease phenylketonuria. Independent
studies have often raised health concerns.
Dr. Lewis Stegink, a pediatrics professor at the University of Iowa who
repeatedly has produced studies, that he says, support aspartameís
safety, has received more than $1.3 million dollars in research grants
and gifts, including lab equipment, from the (NutraSweet) company since
the early 1970ís, limited university records show.
Metzenbaum said, "If it is a fact that no questions were raised and
more than a million dollars was spent, you have to wonder whether their
job was done thoroughly as it should be done."
Steginkís longtime research collaborator, Dr. Jack Filer, serves as
executive director of the ILSI (International Life Sciences Institute),
the Washington foundation that funds aspartame research.
Filer said he sees no conflict in his dual roles as ILSIís executive
director and a company researcher, but declined to disclose his ILSI
consulting fees. He said all the Iowa research money has gone to
Stegnik.
Filer also said the company (NutraSweet) paid him and Setgnik "$2,000.
to $3,000." to edit a book, "Aspartame," about research on the
sweetener, and another $1,000. or $1,500. to each of the contributors,
including researchers whose studies helped the company win FDA approval.
The book states that "the extensive research program carried out to
demonstrate aspartame safety may serve as a new standard for the study
of food additives." Filer said he had been "maligned over the years for
taking money from corporations," but that the funding source never has
influenced his findings.
Dr. David Hunninghake of the University of Minnesota was picked to
study aspartameís effect on the liver by former Searle research director
Daniel Azarnoff, once Hunninghakeís mentor at the University of Kansas,
a Hunninghake associate said. He said Searle helped design the study.
Susan Schiffman, named to head a Searle-funded Duke University medical
School study into NutraSweetís link to headaches, is a former General
Foods and Searle consultant. Her research at Duke, where the medical
school has a new Searle Center, has fallen under the office of
university vice president William Anylan, a former Searle director.
Schiffman said Anylan had no role in Searleís promise to cover all costs
of the study, which is expected to cost "hundreds of thousands of
dollars." She said she took no salary for her work.
Another industry-backed researcher has been Ann Reynolds, now
chancellor of California State University at Long Beach. Dr. John Olney
asserted that in a 1971 study, Reynolds confirmed his findings that the
sweetener destroyed nerve cells in infant mice, but Searle did not
notify the FDA until 1975 or 1976, after the FDAís initial review. Dr.
Daniel Azarnoff, Searleís former science director, and other Searle
officials have denied withholding any studies from the government.
Reynolds also co-authored a Searle monkey study that contradicted
earlier aspartame research leading to seizures in monkeys. Dr. Olney
alleged that Reynolds, who did not return phone calls, and several other
company-funded researchers "have a pattern of avoiding" scientific peer
review. Industry spokesmen contend that few studies by scientific
critics of NutraSweet have undergone peer review. But few such clinical
studies have been completed because of a funding shortage.
George Liepa, a nutrition professor at Texas Womanís University said he
was required to discuss his findings with Searle before reporting that
NutraSweet "is safe" for diabetics on hemodialysis. Dr. David Horwitz,
an associate professor of medicine at the University of Illinois, who
studied NutraSweet and diabetics, said the company did not influence the
outcome, But, "The results were favorableÖ. Obviously, that is perhaps
why Searle was eager to fund an additional study of ours."
Dr. Richard Wurtman was an ardent defender of NutraSweetís safety at
public hearings six years ago (1981). Now he is one of the artificial
sweetenerís harshest critics.
"I think the likelihood is very strong that NutraSweet does produce
serious and potentially damaging brain effects in a number of people,"
the nationally known neuroscientist from Massachusetts Institute of
Technology said in a recent series of interviews.
Wurtmanís seemingly enigmatic flip-flop from a position as a G.D.
Searle Co. consultant to a role as a foe urging restrictions on
marketing the firmís best-selling product appears to be much at the
center of the controversy over NutraSweetís safety.
Wurtman says his views simply changed with the evolution of his
scientific studies and his growing skepticism of industries attitude
toward research.
His sometimes stormy relationships with the company and an industry-
funded foundation, the ILSI, provide a glimpse of the maneuverings
surrounding research into a major food additive.
Wurtman, a brash-talking, hard-driving head of a major research
laboratory, said he unilaterally severed his consulting relationship
with Searle in 1985 after he grew concerned about NutraSweetís effects
and the companyís inaction. He said he rejected several approaches by
the firm, (the NutraSweet Co.) since its sale that year to the Monsanto
Corp., to rekindle the consulting arrangement.
Wurtman accuses NutraSweet Co. officials of "misrepresenting" the
nature of company-financed studies into links between the sweetener,
generically known as aspartame, and epileptic seizures, of sidestepping
key safety issues, and of threatening to veto his grant application to
ILSIís aspartame committee.
A spokesman for the NutraSweet Co. described Wurtmanís public attacks
as a "political issue," but declined to elaborate.
Wurtmanís relationship with Searle, The NutraSweet Co., and many of the
companies that sell NutraSweet-flavored products dates to 1978.
Beginning that year, according to public records, ILSI provided more
than $200,000. to finance his research on caffeine, a common beverage
ingredient that was under FDA scrutiny.
Wurtman said he found no ill health effects during his caffeine
research, and his relationship was "excellent" with ILSI ≠ a spinoff of
the National Soft Drink Association.
During the same period in 1978, he said he rejected a Searle offer of
financial support for research on amino acids. Phenylalanine and
aspartic acid, two such amino acids, are the main components of
NutraSweet.
He said Dr. Sanford Miller, chief of FDAís Bureau of Foods, later
sought his testimony before a 1980 Public Board of Inquiry because he
openly stated his belief that neither glutamate nor aspartic acid, a
similar compound to that in NutraSweet, would not cause brain damage.
Wurtman strongly defended aspartame at the hearing.
He said he did not focus on phenylalanine until about 1983, when he
learned the FDA was considering expanding use of the low-calorie
sweetener, approved two years earlier for dry foods, to include
carbonated soft drinks.
From his caffeine research, Wutman said, he was aware of the exploding
soft drink market and concluded "that the use of aspartame was going to
go up considerably."
"I was genuinely concerned that there might be an increase in brain
phenylalanine levels."
Wurtman said that, while phenyalanine is vital to the brain, it can
serve as a barrier to 20 other amino acids that provide protein.
At a meeting in July 1983, Wurtman said he told National Soft Drink
Association officials that "if you put large amounts of aspartame in
soft drinks and people drink as much as I think they will, there are
going to be problems."
Wurtman said that after the industry accepted his idea for combining
NutraSweet with saccharin to cut the danger level, he accepted a Searle
offer to serve as consultant and relations were "all very friendly and
chummy".
Wurtman said he became "convinced that these people really want to know
the extent to which their product may be a real problem".
Shortly after he took the consulting job, he began getting letters from
seizure victims who believed their problems stemmed from NutraSweet.
Wurtman said he when advised Dr. Gerald Gaull, Searle vice president
for nutrition and medical affairs, in the Spring of 1985 that he thought
there was a link, "there was a very rapid souring of their
relationship".
During a visit to his MIT laboratory, Wurtman said, Gaull asked him to
review a proposal for a seizure study by him and his collaborator,
Harvard University neurologist Donald Schomer. He charged that when he
advised Gaull the pair would seek funding from ILSI, Gaull "got very
angry" and said, "We (meaning Searle), are active members of the ILSI
and we will veto your study".
"I was incredulous that he would say it to me, and I was dumbfounded
that he would say it in front of a witness," Wurtman said.
Schomer said he did not recall the comment. Gaull said, "There is no
way that I can veto anything at ILSI," because Searle has only one of 12
votes on the ISLI aspartame committee. He did not deny making the
threat.
Wurtman charged that Gaull later advised ISLI that two company-funded
seizure studies already were under way, and the foundation declined to
approve Wurtmanís grant.
In July of 1985, Wurtman said, he and three other scientists who had
expressed concerns about NutraSweet were among a group invited to
Gaullís home in Northeast Harbor, Maine, for a two-day conference.
"I left there with the conclusion there was no way these people were
going to do an honest job in assessing the possibility that aspartame
contributed to seizures," Wurtman said.
He said he also was skeptical because, as a company consultant, Searle
had asked him to chair its scientific advisory committee, a role in
which the company could use his name to defend the integrity of its own
research. But, he said, Searle refused to let him see protocols and data
from its studies.
"They wanted the name, but not the reality," he said. Frustrated by
these developments, Wurtman said he wrote a letter to Robert Shapiro,
president of Searle and later of the NutraSweet Co.
"Dear Bob," the letter said, "I know youíll agree that my value to
SearleÖ derives in part from my telling the company some things that it
would rather not hearÖand then from helping the company to deal with
those things."
"One such thing is that some consumers may develop significant medical
symptoms after consuming very large amounts of aspartame, particularly
if they happen, concurrently, to be on a low-calorie, low-protein,
weight-reducing dietsÖ If Searle-supported studies are going to
contribute to our understanding of these people and their symptoms, then
the studies have to include them, and not be restricted to people who
have a can or two of soda per day."
He said Shapiro never answered the letter.
Wurtman said he resigned his consulting role a short time later and
rejected company efforts in the ensuing months to reinstate the
arrangement.
UPI Investigative Report: 10-07-87
Seizure, Blindness victims point to NutraSweet
By GREGORY GORDON
WASHINGTON (UPI) Susan Yarmey, a free-lance writer from Quincy,
Mass., awoke on a hot July morning in 1984 with a large bump on her head
and bruises all over her body.
"I had no recollection of what happened. There were marks on the wall,
two wooden steps were broken and there was a nice gash on the wall where
my head hit," she said.
Yarmeyís doctors diagnosed her injuries as resulting from a "classic"
epileptic seizure. She and Massachusetts Institute of Technology
neuroscientist Richard Wurtman believe the incident may be connected to
her consumption of the artificial sweetener, NutraSweet, know
generically as aspartame.
"A friend in New York directed me to the possible effects of NutraSweet
consumption...I was probably, at that particular time period, doing a
liter and a half to two liters (of diet soda with NutraSweet) a day,"
said Yarmey, who said when she stopped taking NutraSweet her problems
disappeared.
Yarmey is not alone. Many NutraSweet consumers, particularly heavy
users, who have suffered headaches, tremors, blindness, allergic
reactions and seizures, blame NutraSweet for their ailments.
Wurtman says he personally is aware of more than 200 cases in which he
suspects NutraSweet has caused health problems such as headaches,
dizziness, and seizures.
Wurtman says the problem might be solved simply by stiffening the
labeling requirements for NutraSweet products so that certain identified
groups can monitor their intake.
"The groups I would identify are pregnant ladies, small children, people
with a history of seizures and people who are taking certain drugs that
interact with phenylalanine," an amino acid in the sweetener, Wurtman
said.
Another former NutraSweet consumer, Shannon Roth, a mother of two who
works as a goldsmith in Ocala, Florida, organized Aspartame Victims and
Their Friends, Inc. after suffering blindness in one eye. She said the
group now has about 700 members.
"I got up in the morning and had two packs (of Equal, the NutraSweet
tabletop version) in each cup of coffee...three or four cups of coffee
before noon. Then I'd switch to the iced tea with it," Roth said.
In the summer of 1984, Roth said, she began to experience headaches,
sleep and memory loss, and irritability.
After getting out of bed one morning, she discovered she couldn't see
when she closed her right eye, Roth said. "I could see like through a
black veil. It was like a centralized, almond-shaped black spot," she
said.
Doctorsí laboratory tests failed to trace the cause of her partial
blindness, she said, and one doctor told her not to expect vision to
return to her eye.
Roth said she suspected NutraSweet as the cause after learning of a
similar case that was allegedly linked to the sweetener, and after about
four weeks without NutraSweet, her headaches and other problems ceased.
Her sight began to return a few weeks later, she said.
Joyce Wilson, a real estate agent in Stockbridge, Georgia, said she
began suffering from high blood pressure, dizziness and other ill
effects in 1982 after using Equal in her coffee and eating NutraSweet-
flavored puddings. She said that in 1984 and 1985, she lost some vision.
"I'm not blaming this all on NutraSweet," Wilson said. "I'm just saying
itís a strange coincidence that when I started using it, I started
falling apart."
Dr. Morgan Raiford, an ophthalmologist at Emory University examined
both Roth and Wilson and believes their problems stem from consumption
of the methyl alcohol in NutraSweet.
Dorris Bookhart, 43, a legal secretary in Lodge, S. Carolina, started
having what were later diagnosed as temporal lobe seizures in August of
1984. At the time, she said, she was drinking four 16-ounce bottles of
Diet Coke a day, as well as diet lemonade. Both contained NutraSweet.
In January of 1985, after six months of problems, she suffered a grand
mal seizure, a convulsive episode in which the victim loses
consciousness, she said. Her doctors were mystified by the seizures, but
they ruled out epilepsy, Bookhart said.
She said she suspected NutraSweet as the culprit when, at her husbandís
suggestion, she stopped drinking Diet Coke and the problems ended.
"I've cried a lot of times thinking these people have destroyed my life
and there isn't a damn thing I can do," she said.
Another heavy user of the artificial sweetener, Larry Taylor of
Arlington, Texas, said he was hospitalized for five or six days to
undergo a battery of tests after suffering a grand mal seizure in 1985.
He was also a victim of migraine headaches that became more frequent
between 1982 and 1984. After his seizures, Taylor, an anesthetist, was
not allowed to work until January of this year (1987), a disability he
said left him "financially devastated."
---------
What critics say about NutraSweet
By GREGORY GORDON =
WASHINGTON (UPI) ≠ Despite the NutraSweet Co.ís insistence that scores
of company studies have "proved" the sweetener is harmless, hereís a
sampling of concerns from a hard core of scientific critics:
What the critics say about NutraSweet
Dr. Rueben Matalon of the University of Illinois has reported that
heavy consumption of NutraSweetís main component ≠ the amino acid
phenylalanine ≠ may cause neurological problems such as loss of memory
and concentration. Matalon and Dr. Louis Elsas of Emory University say
they fear aspartame consumption by some pregnant women can cause
irreversible brain damage in fetuses. They worry most about women among
an estimated 4 million to 20 million Americans who are carriers of the
genetic disease, phenylketonuria ≠ characterized by the liverís
inability to process phenylalanine. While there are an estimated 20,000
to 30,000 PKU victims nationwide who are warned not to take NutraSweet,
carriers or heterozygotes, do not have the disease and generally are
unaware of their sensitivity, they said. The company has said that the
Food and Drug Administration concluded, "NutraSweet did not present any
additional health risk to pregnant women."
Dr. Paul Spiers, a clinical neuropsychologist at Bostonís Beth Israel
Hospital, found in a recent pilot study that, after consuming
NutraSweet, some subjects with no previous problems failed to show the
usual improvement in performance on cognitive tests. He plans further
research. But Dr, Harris Lieberman of the Massachusetts Institute of
Technology, who has received industry funding for NutraSweet research in
the past, said his study of 20 adult males indicates that aspartame "has
no measurable effect on mood and performance in normal humans."
In St. Louis, Washington University allergist, Dr. Anthony Kulczycki
found that two women given NutraSweet capsules and a placebo suffered
allergic reactions to NutraSweet. The women reported hives and other
skin reactions after using the sweetener.
Dr. Donald Johns, a neurology resident at Massachusetts General
Hospital, reported last year that a "double-blind" study of a woman
suffering migraine headaches showed her problems were aggravated by
consumption of NutraSweet. NutraSweet, known generically as aspartame,
consists of phenylalanine and another amino acid, aspartic acid, linked
to a small quantity of methyl alcohol. Scientific critics seem to worry
most about phenyalanine.
Dr. Richard Wurtman, Massachusetts Institute of Technology
neuroscientist, says heavy NutraSweet consumption may so flood the
bloodstream with phenyalanine that other essential amino acids are
blocked from reaching the brain, causing chemical changes that can
affect behavior and lower the threshold at which many suffer epileptic
seizures. Wurtman and Dr. Donald Schomer of Harvard University are
testing seizure victims who used NutraSweet, particularly some whose
bodies may have trouble processing phenylalanine. The NutraSweet Co.
concedes aspartame raises phenylalanine levels, but says no harm
results, and that consuming the amino acids in NutraSweet "is just like
eating other foods containing the same protein components."
Another Wurtmen protege, Dr. Timothy Maher of Massachusetts General
Hospital, supported his mentor by reporting that mice, given a seizure
inducing drug and NutraSweet, suffered more seizures than those
receiving the drug alone. Dr. Henry Haigler, a scientist in a NutraSweet
Co. sister firm, said his similar study showed "no effect on seizure
thresholds."
Dr. William Pardridge of the UCLA Medical School, who also has done
phenylalanine research, said he most fears the sweetenerís effect on
children, who, he says, "are more likely to approach the FDAís
acceptable daily intake level of 50 milligrams per kilogram of body
weight. If youíre a child, seven to twelve years of age, the chances are
good you'll have five servings a day" ≠ close to the acceptable level,
he said. But Dr. Harvey Levy, head of the PKU clinic at Bostonís
Childrenís Hospital, wrote the Journal of the American Medical
Association that Pardridge made an "inaccurate interpretation" of their
data in predicting brain damage effects on fetuses from aspartame. Any
danger level, they said, "would seem to be considerably higher" than
levels from NutraSweet consumption.
Dr. Woodrow Monte, an Arizona State University food scientist, and Dr.
Morgan Raiford, an ophthalmology professor at Emory, worry that a
NutraSweet breakdown product, methyl alcohol, could produce severe eye
damage. Last year, Raiford examined more than a half dozen persons who
said they suffered eye problems after consuming NutraSweet heavily. He
said he diagnosed some cases of optic nerve damage and suspects
NutraSweetís methyl alcohol is the culprit. The company denies any
connection between NutraSweet and eye problems and has offered exams to
consumers who complain of such problems.
Dr. Sidney Wolfe, executive director of the Washington-based Health
Research Group, said, "The thing thatís really worrisome is that it
clearly affects brain metabolism in animals, and anyone who disputes
that is irresponsible."
Dr. John Olney of Washington University expresses fears about brain
tumors ≠ a problem he and other scientists say would not show up in
humans for 20 years and would be difficult to trace to NutraSweet. Olney
said Searle rat studies have shown conflicting brain tumor data. As
early as 1971, Olney reported that aspartic acid in aspartame killed
cells in the brainís hypothalamus region, which regulates glandular and
hormonal functions.
----------
The NutraSweet Company responds to UPI series.
WASHINGTON (UPI) ≠ In response to the United Press International series
of articles on NutraSweet, The NutraSweet Co. issued the following
statement:
A series of articles to be released this week by UPI seriously
misrepresents the vast body of scientific evidence, which establishes
the safety of aspartame.
Contrary to the impression created by these articles, the scientific
record has been carefully reviewed by independent and official
scientific and regulatory agencies around the world.
Without exception, each of these agencies has concluded that aspartame
is a safe sweetener which can be used as a normal part of the daily
diet. The following quotations are representative of expert scientific
and medical opinion around the world.
U.S. Food and Drug Administration: "The data and information supporting
the safety of aspartame are extensive. It is likely that no food product
has ever been so closely examined for safety...Few compounds have
withstood such detailed testing and repeated close scrutiny, and the
process through which aspartame has gone should provide the public with
additional confidence of its safety."
American Medical Association Council on Scientific Affairs:
"Consumption of aspartame of normal humans is safe..."
American Diabetes Association: "Aspartame has been determined to be
safe for the general population as well as for people with diabetes."
Government of Canada (Health Protection Branch): "Aspartame is one of
the most extensively studied chemicals permitted for use in food...Based
on the available data it has been concluded that aspartame would not
pose a hazard to health when used in accordance with the current
provisions of the Canadian food and drug regulations."
Government of Denmark (Danish Food Institute): "Research published in
the scientific literature and/or studied in detail by governments and
independent scientific committees maintains that the use of aspartame as
an additive does not bear any health risk at all...There is, therefore,
no toxicological basis for believing the intake of aspartame is soft
drinks and food products should give rise to harmful effects in children
or adults, even people with high level usage."
Government of Great Britain (UK Committee on Toxicity of Chemicals and
Food): "Following detailed consideration of all toxicological data, we
see no objection to the use of aspartame in food."
Other scientific agencies that have reviewed the evidence and confirmed
the safety of aspartame include the World health Organization of the
United Nations; the Scientific Committee on Foods of the European Common
Market; the Epilepsy Institute; and the American Academy of Pediatrics.
Aspartame has been reviewed and approved as a safe sweetener by the
official food regulatory authorities in all the leading nations of the
world, including many which forbid or restrict the usage of other
sweeteners.
A recent article by Harvard Medical School Prof. Peter Dews reviewed
the "massive evidence" that establishes the safety of aspartame. Dr.
Dews concluded: "Many articles of everyday consumption that are known to
be safe might not survive the scrutiny of such intensive and continued
investigation."
The respected consumer publication Consumer Reports summarized its
conclusions this way: "An objective weighing of the evidence suggests
that aspartame is the artificial sweetener to be preferred on safety
grounds."
The UPI articles also seek to discredit the process by which aspartame
was reviewed and approved by the FDA.
These charges have been conclusively rebutted by both the FDA, itself,
and by the General Accounting Office, the investigative agency of the
Congress. A full GAO report on the approval process concluded that the
FDA had properly followed the appropriate procedures and had adequately
addressed the scientific issues.
The UPI series is replete with misstatements and distortions, which
convey a totally misleading impression of the scientific facts. Any
concern or anxiety by consumers who read these articles is absolutely
unwarranted. Aspartame is safe as approved by FDA and regulatory
authorities around the world. Any contrary impression created by UPI
articles is a serious disservice to the public.
PART 2:
(Editorís Note: UPI investigative reporter Gregory Gordon spent eight
months examining industry research into the popular artificial sweetener
NutraSweet and the Food and Drug Administrationís handling of the
product permeating the diet food and drink markets. here is the second
in his three-part series.)
PART 2: NUTRASWEET APPROVAL MARRED BY CONTROVERSY
by: Gregory Gordon
WASHINGTON (UPI) Pouring over laboratory rat studies in the spring of
1981 in the governmentís final safety review of a new artificial
sweetener, senior statistician Satya Dubey of the Food and Drug
Administration was troubled.
Dubey, a member of a special FDA "commissionerís team" formed to help
decide the fate of the product to be known as NutraSweet, wrote an
internal memo that brain tumor data from the rat tests was so
"worrisome" that he could not recommend approval.
Two other statisticians on the six-member team agreed with Dubey that
the Chicago-based G.D. Searle Co. had not proved with "reasonable
certainty" the safety of the sweetener, known generically as aspartame.
A 1980 Public Board of Inquiry had voted 3-0 to ban aspartame because of
similar fears.
But a few weeks later on July 18, 1981, new FDA Commissioner Arthur
Hull Hayes, Jr., a pharmacologist who had been in office less than three
months and had little background in food additives, overturned the board
and approved the use of aspartame in dry foods.
The ruling, one of the first regulatory actions of the Reagan
presidency, came at a time of growing concern that the most widely used
low-calorie sweetener, saccharin, was linked to cancer. Thus Hayesí
approval of NutraSweet profoundly changed the eating habits of millions
of Americans, handing Searle a financial bonanza.
It also climaxed a topsy-turvy, eight year FDA review process in which
the agency approved the sweetener, then banned it and demanded a grand
jury investigation of its manufacturer, only to reverse course again
after reexamining the issue at least five times.
Now, six years after Hayesí ruling, its uses expanded, the sweetener is
widely consumed in diet sodas, puddings, cereal, drink mixes, and even
chewing gum and vitamins. Yet NutraSweet and its FDA approval remain at
the center of controversy, the sweetenerís safety questioned by a small
corps of independent scientists; defended by its manufacturer and the
diet food and drink industry.
In a recently released report, the General Accounting Office concluded
that the FDA "adequately followed" its food additive approval process on
NutraSweet.
Congressís investigative arm did not evaluate the sweetenerís safety. A
federal appeals court also has rejected court suits by consumer groups
challenging the NutraSweet approval.
United Press International has learned that more than 10 federal
officials involved with the NutraSweet review have taken private sector
jobs linked to the industry ≠ among them, Hayes, an acting FFDA
commissioner and former chiefs and acting chiefs of the agencyís Bureau
of Foods.
In addition, many of the scientists who have produced favorable studies
or served as outspoken advocates of NutraSweetís safety have received
grants or consulting fees from Searle and the industry.
Consumer lawyer, James Turner, who has unsuccessfully pressed petitions
for a NutraSweet ban as part of an 11 - year campaign against the
sweetener, asserted, " NutraSweet is an opportunity for the entire
country to look in great detail at how we make food safety decisions. It
is a rickety, 19th Century process."
G.D. Searle began to study the artificial sweetener aspartame soon
after a company laboratory chemist, James Schlatter, stumbled on the
compound when he licked it off his finger while conducting ulcer
research in 1965.
In a memo on Dec. 28, 1970, a Searle official laid out a plan for
winning FDA approval for the sweetener. " We must create an affirmative
atmosphere in our dealing with them," Herbert Helling wrote senior
company executives. Helling suggested that Searle representatives
carefully order proposals to the FDA to put Bureau of Foods officials
"into a yes saying habit." If FDA officials could be swayed to do Searle
some favor, he asserted, it would "help bring them into a subconscious
spirit of participation."
On July 26, 1974, just 15 months after Searle petitioned for approval,
FDA commissioner Alexander Schmidt approved aspartame use in dry foods,
allowing a 30-day period for public hearings and comment. He acted on a
strong endorsement from the Bureau of Foods, now called the Center for
Food Safety and Applied Nutrition (CFSAN).
At that point, consumer attorney Turner, author of a 1970 book about
food additives, objected to the short comment period. Turner was joined
in his protest by a now-defunct public interest group and by Dr. John
Olney, a Washington University neuropathologist who had linked aspartame
to brain lesions in mice.
Schmidt promptly froze the approval. In an action that was the first of
its kind, he ordered that a Public Board of Inquiry be named to look
into aspartame.
Schmidt also had been alerted to conflicts between Searle research
reports and conclusions from independent animal studies that the firmís
anti-infective drug, Flagyl and its cardiovascular drug Aldactone may
cause cancer. He named a Bureau of Drugs task force to investigate.
Philip Brodsky, the unitís since-retired lead investigator, said
aspartame was included in a broad inquiry into Searle animal studies on
five drugs and the Copper-7 intrauterine device to surprise the company.
"We didnít think theyíd expect us to cover it."
The task force assailed Searleís conduct of research on most of the
products, including aspartame, in a searing, 84-page report.
"At the heart of the FDAís regulatory process," the report said, "is
its ability to rely upon the integrity of the basic safety data
submitted by sponsors of regulated products. Our investigation clearly
demonstrates that, in the G.D. Searle Co., we have no basis for such
reliance now."
The task force charged, for example, that the company removed tumors
from live animals and stored animal tissues in formaldahyde for so long
that they deteriorated. Instead of performing autopsies on rhesus
monkeys that suffered seizures after being fed aspartame, the company
had financed a new monkey study with a different methodology that showed
no problems.
For the next seven years, Searleís petition was tied up in reviews by
the task force and other sharply critical FDA panels. At the task
forceís request, Richard Merrill, the FDAís general counsel, demanded in
a letter that Samuel Skinner, the U.S. attorney in Chicago, open a grand
jury investigation of Searle and three of its employees.
One Searle official named by Merrill was Robert McConnell, who had been
director of Searleís Department of Pathology and Toxicology and oversaw
most of the companyís aspartame research.
McConnellís Detroit lawyer, Gerald Wahl, said that as the inquiries
heated up, his client was suddenly awarded a $15,000. bonus and asked to
take a three-year sabbatical by director Wesley Dixon. Wahl said Dixon
told McConnell he had become a "political liability," a remark Dixon
later denied making.
McConnell received his annual salary of more than $60,000 during the
sabbatical at the Massachusetts Institute of Technology, but he never
got his job back, and ended up suing the company, Wahl said.
"I've represented hundreds of executives, but I've never seen anybody
get the deal that McConnell got," he said. "When you boil it all down,
they were looking for continued support from McConnell during the
inquiries."
Wahl said McConnell had felt pressure to hurry his research because of
the "profit motive," but the company never ordered him to alter test
results.
Chief investigator Brodsky said that "politicized" handling of the task
force disclosures, at hearings chaired by Sen. Edward Kennedy D-Mass.,
was one reason he retired in 1977. He said the main witnesses, Searle
executives, and top FDA officials uninvolved in the investigation gave
"the wrong answers to the wrong questions"ÖThey didnít even let the
experts answer the questions.
The FDA, rocked by controversy, established a set of "good laboratory
practices" ≠ minimum standards for future corporate research work.
Richard Ronk, deputy Bureau of Foods chief, stressed that Searle
practices were typical of the industry at the time, "not the worst on
the block."
Searleís fortune did not begin to change until 1977, when Donald
Rumsfeld, White House Chief of Staff under Gerald Ford, was named its
new president.
Turner alleged that Searle chose, with Rumsfeldís hiring, not to redo
the questioned studies on belief he could handle aspartame as "a legal
problem rather than a scientific problem."
The company also hired another Ford White House official, William
Timmons, as a Washington lobbyist.
Before deciding on Merrillís grand jury request, U.S. Attorney Skinner
and an aid agreed in February 1977 to meet with lawyers for Searle,
including Newton Minow, a partner in the law firm of Sidley & Austin.
A month later, Skinner, a Republican appointee who was looking for a
job as a result of Jimmy Carterís election, informed aids in a memo that
he had begun preliminary employment discussions with the law firm.
Withdrawing from the Searle matter, Skinner suggested his designated
successor, Thomas Sullivan, be left to decide whether to open a grand
jury inquiry-a move that delayed action for at least four months.
Sullivan took office just 12 weeks before expiration of the statute of
limitations for prosecuting alleged false statements on aspartame. While
the grand jury inquiry ultimately was convened, those allegations were
not explored.
Skinner denies any conflict of interest.
Assistant U.S. Attorney William Conlon worked with the grand jury until
October 12, 1977, two days after the statute of limitations expired on
the aspartame allegations. No indictments were brought on the few
matters investigated. Conlon, who declined comment, joined Sidley &
Austin 15 months later.
Following issuance of the task force report back in March 1976 and
facing a dilemma as to how to proceed, the FDA sought new reviews of
several "pivotal" studies ≠ long term animal tests to see whether
aspartame causes cancer.
A new five-member internal FDA task force analyzed three of these
studies, and Universities Associated for Research and Education in
Pathology, Inc., a consortium formed by 15 universities, was contracted
to look at another dozen.
Much like the earlier team, the five-member FDA task force, headed by
veteran Chicago inspector Jerome Bressler, assailed the quality of
animal tests into whether the substance might cause birth defects and
tumors.
The report said Searle laboratory employee Raymond Schroeder, who
worked on related research, first told investigators the feed in the
study of the aspartame breakdown product DKP (diketopiperazine) was so
inadequately mixed it appeared the rats could "discriminate" and avoid
eating the DKP.
Schroeder, who has worked for another company since 1975, later backed
off his statement. He told UPI, "I just didn't feel qualified to speak
on something I didn't work onÖThereís no one twisting my arm."
Bressler criticized the companyís "sloppiness" on all three studies.
"The question you've got to ask yourself," he said in an interview, "is:
Because of the importance of this study, why wasn't greater care taken ?
The study is highly questionable because of our findings. Why didn't
Searle, with their scientists, not closely evaluate this, knowing fully
well that the whole society, from the youngest to the elderly, from the
sick to the unsickÖwill have access to this product?"
Howard Roberts, acting director of FDAís Bureau of Foods, appointed a
five-person task force to review the Bressler teamís findings pending a
decision on whether to throw out the three tumor and birth-defect
studies.
Jacqueline Verrett, a senior scientist on the review team, said members
were barred from stating opinions about the research quality. "It was
pretty obvious that somewhere along that line they (bureau officials)
were working up to a whitewash," she said. "I seriously thought of just
walking off of that task force."
Verrett, now a private consultant, said that she and other members
wanted to "just come out and say that this whole experiment was a
disaster and should be disregarded."
But on September 28, 1977, the panel reported that deviations between
Searleís raw data and its FDA submissions were "not of such magnitude as
to alter its conclusion."
Verrett said the bureauís intent seemed to be "to tone down what was
really found." She noted the bureau felt pressure because safety
concerns also had been raised about cyclamate, another alternative for
the cancer-linked sugar substitute, saccharin.
In October, 1978, a year after ordering the review that helped get
Searleís petition back on track, Robertís (acting Director of Bureau of
Foods) quit to become vice president at the National Soft Drink
Association. The NSDAís members later marketed a stream of NutraSweet-
flavored diet soft drink products.
Reached at NSDA, Roberts dismissed Verrettís criticism, asserting the
task force report "really was of no importance." He said he had no
concerns about the appearance of his taking the NSDA job, stressing he
does not represent NSDA before the FDA. "I sleep well at night," he
said.
Negotiations for an additional, outside review of Searleís studies had
begun with an August 4, 1976 meeting between Searle and 10 FDA
officials. During the meeting, Searle officials said they desired to
help pick the consultant to perform the review, and internal FDA memo
said.
Agency memos show the FDA soon was negotiating with the Universities
Association for Research and Education in Pathology for a half-million
dollar, company-funded "validation" of a dozen Searle studies.
The pathology organizationís review concluded that Searleís studies
were authentic and the discrepancies largely inconsequential.
Adrian Gross, an investigative consultant to the 1975 task force, later
said the 16-month review was "at best, irrelevant" because the group was
limited to analyzing "whether Searle lied about the data in its tests".
"It was not our task to challenge the validity of the experimental
methods, since the FDA had itself already accepted the methodology", the
groupís executive director, Kenneth Endicott, said.
Jere Goyan, who was FDA Commissioner in 1980, said he would have put
less weight on the review than on the findings of FDAís task forces.
Goyan also suggested that, after approving aspartame in 1974, the FDAís
Bureau of Foods may have "felt they had to keep their previous
position."
Regardless, the pathology groups findings carried major weight in the
final approval decision. The chairman of the 1980 Public Board of
Inquiry, Dr. Walle Nauta of the Massachusetts Institute of Technology,
said the board had to rely on those findings because it was denied
access to the task force reports by FDA officials.
"There was absolutely no way in which we could decide who was right
here," Nauta said. "We simply had to accept the data as they stood."
Nauta was joined on the panel by Drs. Vernon Young of MIT and Peter
Lampert of the University of California at San Diego.
Before voting 3-0 to ban NutraSweet on the narrow cancer issue, the
board itself was drawn into allegations of bias because two of the three
members came from MIT ≠ as did Bureau of Foods Chief Miller and several
scientists involved in the controversy.
Between 1979 and 1982, four more FDA officials who participated in the
approval process took jobs linked to the NutraSweet industry: Pape;
acting FDA commissioner Sherwin Gardner; Albert Kolbye, who was
associate director of the Bureau of Foods for toxicology, and Mike
Taylor, an FDA lawyer who represented the bureau before the Board of
Inquiry. All four denied any conflict of interest.
After the Board of Inquiry ruled against NutraSweet on Sept. 30, 1980,
Searle waited until January 21, 1981, the day after President Reaganís
inauguration, to press for a reversal of the FDA commissioner ≠ assuring
the new administration would decide the issue.
Jere Goyan, Hayesí predecessor as commissioner, said he found the delay
curious because, after eight years of legal battles, financially
struggling Searle "obviously was most anxious to have this thing
approved."
Robert Dormer, a lawyer for the NutraSweet Co., said there was nothing
special about the Jan. 21 date or the papers filed that day.
But with Reaganís election, it was virtually assured that a republican-
appointed commissioner would replace Goyan and decide the appeal- and
Searle had strong GOP connections with Rumsfeld at the helm.
Goyan had set up a five-member "commissionerís team" of scientists with
no prior involvement in the issue to review the boardís ruling.
On May 10 and 13, 1981, a month after Hayes took office, scientists
Satya Dubey, Douglas park, and Robert Condon each laid out concerns
about the sweetenerís safety in memos to team lawyer Joseph Levitt.
Dubey not only expressed reservations about reported incidence of brain
tumors in one key Searle rat study, but also said key data in another
study appeared to have been altered. Dubey, who still works at FDA,
refuses to discuss the matter.
Condon, another statistician on the team, and Park, staff science
advisor in the agencyís Office of Health Affairs, each said the
available evidence failed to prove NutraSweetís safety or lack of
safety.
Park said that Levitt hurried the panel to decide the issue. "They
wanted to have the results yesterday," he said. "We really didnít have
time to do the in-depth review we wanted to do."
Park said Levitt met frequently with Hayes and "was obviously getting
the pressure to get a resolution and a decision made."
Sources have said the office of Sen. Howard Metzenbaum, D-Ohio, has
received allegations of political influence in Hayesí final decision-
making process.
In a letter written after the FDA cleared NutraSweet, one former Searle
saleswoman, Patty Wood-Allott, asserted the Rumsfeld told his sales
force shortly after Reagan took office that if necessary, "he would call
in his markers and that no matter what, he would see to it that
aspartame would be approved that year." Rumsfeld declined to return
phone calls.
With three of five scientists on the commissionerís team opposing
approval, it was decided to bring in a toxicologist for his opinion on
isolated issues.
Goyan said if the decision were his, he never would have enlarged the
team. While the panel did not vote, it ended up split 3-3.
Levitt, who normally would have been expected to draft an options paper
spelling out scientific evidence on key issues, took an unusual tact. He
circulated an approval recommendation ≠ and only backed off when Dubey,
Park and Condon objected, team members said.
Levitt said he was not directed to draft the approval memo, but did so
as a "tactical" step to break the teamís week-long impasse by forcing
each scientist to state his views.
"It worked didnít it?" said Levitt, who later was promoted to a post as
an executive assistant to the FDA commissioner.
One team member said that during discussions, Hayes, appeared to be
abandoning the agencyís traditional standard of "reasonable" proof of
safety and looking for "proof of hazard."
Hayesí July 1981 approval decision came in the face of a Searle threat
to file a suit challenging the regulatory delays.
His ruling relied in part on a late rat study of brain tumors submitted
by Ajinmoto, a Japanese company that manufactures aspartame for Searle.
That study, however, tested Wistar rats, a strain that some scientists
said is more tumor resistant than the Sprague-Dawley rats used in
earlier research.
In his decision, Hayes wrote: "Few compounds have withstood such
detailed testing and the repeated close scrutiny and the process through
which aspartame has gone should provide the public with confidence of
its safety."
In late 1982, Searle petitioned for FDA approval to use the sweetener
in diet soft drinks and childrenís vitamins. On a day when Hayes was
away, Novitch approved the petition, increasing the acceptable daily
intake level for humans by nearly half, from 34 mg to 50 mg per kilogram
of body weight.
Novitch, now in private industry, said he and Hayes had worked together
on the matter, but declined to say why he was left to sign the approval.
Just weeks later, Hayes resigned under the cloud of an internal Dept. of
Health and Human Services investigation into his acceptance of
gratuities from FDA-regulated companies ≠ including free rides aboard
jets owned by a major NutraSweet user, the General Foods Corp.
Shortly after being named Dean of the New York Medical school, Hayes
also became a consultant to the New York-based public relations firm of
Burson-Marsteller, which represents the NutraSweet Co. and several major
users.
Hayesí former top spokesman, Wayne Pines, who previously had joined the
firm, said he approached Hayes because he thought him "an added value"
to clients.
Hayes, now president of the E.M. Pharmaceutical Co. in Hawthorne, N.Y.,
declined comment for this series of articles. He has in the past denied
any impropriety in his consulting role, which sources said paid him more
than $1000. per day.
Burson-Marsteller vice president, Buck Buchwald stressed that Hayes was
not involved in NutraSweet issues and worked but 10 to 15 days a year.
But a former Burson-Marsteller employee, who requested anonymity, said
Hayes was hired precisely because of his decision on NutraSweet and
other issues affecting company clients.
Sen. Metzenbaum said it was "at the very leastÖunbecoming, at the very
most, it probably was inappropriate" for Hayes to accept the position.
In July 1986, Anthony Brunetti, a FDA consumer product officer who
drafted the 1983 notice approving NutraSweet use in soft drinks, also
took an industry job, joining the soft drink association as a science
advisor. Brunetti said he cleared the move with the FDAís ethics
officer.
"My situation," he said, "is no different than many, many peopleÖthat
go through the revolving door. It can be made to look like there is some
duplicity going on. In terms of my own conscious, I have no problem."
Ron Lorentzen, an FDA toxicologist who was asked by current Bureau of
Foods chief Sanford Miller to perform a separate, internal review of the
agencyís handling of aspartame, described it as a "tortured" story.
But despite the myriad questions and revolving door issues, he asserted
the FDA responded to each issue "in a way, perfectly reasonable." Other
questions have arisen over the company and industryís funding of
researchers who have invariably supported NutraSweetís safety ≠ with the
exception of people with the rare disease phenylketonuria. Independent
studies have often raised health concerns.
Dr. Lewis Stegink, a pediatrics professor at the University of Iowa who
repeatedly has produced studies, that he says, support aspartameís
safety, has received more than $1.3 million dollars in research grants
and gifts, including lab equipment, from the (NutraSweet) company since
the early 1970ís, limited university records show.
Metzenbaum said, "If it is a fact that no questions were raised and
more than a million dollars was spent, you have to wonder whether their
job was done thoroughly as it should be done."
Steginkís longtime research collaborator, Dr. Jack Filer, serves as
executive director of the ILSI (International Life Sciences Institute),
the Washington foundation that funds aspartame research.
Filer said he sees no conflict in his dual roles as ILSIís executive
director and a company researcher, but declined to disclose his ILSI
consulting fees. He said all the Iowa research money has gone to
Stegnik.
Filer also said the company (NutraSweet) paid him and Setgnik "$2,000.
to $3,000." to edit a book, "Aspartame," about research on the
sweetener, and another $1,000. or $1,500. to each of the contributors,
including researchers whose studies helped the company win FDA approval.
The book states that "the extensive research program carried out to
demonstrate aspartame safety may serve as a new standard for the study
of food additives." Filer said he had been "maligned over the years for
taking money from corporations," but that the funding source never has
influenced his findings.
Dr. David Hunninghake of the University of Minnesota was picked to
study aspartameís effect on the liver by former Searle research director
Daniel Azarnoff, once Hunninghakeís mentor at the University of Kansas,
a Hunninghake associate said. He said Searle helped design the study.
Susan Schiffman, named to head a Searle-funded Duke University medical
School study into NutraSweetís link to headaches, is a former General
Foods and Searle consultant. Her research at Duke, where the medical
school has a new Searle Center, has fallen under the office of
university vice president William Anylan, a former Searle director.
Schiffman said Anylan had no role in Searleís promise to cover all costs
of the study, which is expected to cost "hundreds of thousands of
dollars." She said she took no salary for her work.
Another industry-backed researcher has been Ann Reynolds, now
chancellor of California State University at Long Beach. Dr. John Olney
asserted that in a 1971 study, Reynolds confirmed his findings that the
sweetener destroyed nerve cells in infant mice, but Searle did not
notify the FDA until 1975 or 1976, after the FDAís initial review. Dr.
Daniel Azarnoff, Searleís former science director, and other Searle
officials have denied withholding any studies from the government.
Reynolds also co-authored a Searle monkey study that contradicted
earlier aspartame research leading to seizures in monkeys. Dr. Olney
alleged that Reynolds, who did not return phone calls, and several other
company-funded researchers "have a pattern of avoiding" scientific peer
review. Industry spokesmen contend that few studies by scientific
critics of NutraSweet have undergone peer review. But few such clinical
studies have been completed because of a funding shortage.
George Liepa, a nutrition professor at Texas Womanís University said he
was required to discuss his findings with Searle before reporting that
NutraSweet "is safe" for diabetics on hemodialysis. Dr. David Horwitz,
an associate professor of medicine at the University of Illinois, who
studied NutraSweet and diabetics, said the company did not influence the
outcome, But, "The results were favorableÖ. Obviously, that is perhaps
why Searle was eager to fund an additional study of ours."
Dr. Richard Wurtman was an ardent defender of NutraSweetís safety at
public hearings six years ago (1981). Now he is one of the artificial
sweetenerís harshest critics.
"I think the likelihood is very strong that NutraSweet does produce
serious and potentially damaging brain effects in a number of people,"
the nationally known neuroscientist from Massachusetts Institute of
Technology said in a recent series of interviews.
Wurtmanís seemingly enigmatic flip-flop from a position as a G.D.
Searle Co. consultant to a role as a foe urging restrictions on
marketing the firmís best-selling product appears to be much at the
center of the controversy over NutraSweetís safety.
Wurtman says his views simply changed with the evolution of his
scientific studies and his growing skepticism of industries attitude
toward research.
His sometimes stormy relationships with the company and an industry-
funded foundation, the ILSI, provide a glimpse of the maneuverings
surrounding research into a major food additive.
Wurtman, a brash-talking, hard-driving head of a major research
laboratory, said he unilaterally severed his consulting relationship
with Searle in 1985 after he grew concerned about NutraSweetís effects
and the companyís inaction. He said he rejected several approaches by
the firm, (the NutraSweet Co.) since its sale that year to the Monsanto
Corp., to rekindle the consulting arrangement.
Wurtman accuses NutraSweet Co. officials of "misrepresenting" the
nature of company-financed studies into links between the sweetener,
generically known as aspartame, and epileptic seizures, of sidestepping
key safety issues, and of threatening to veto his grant application to
ILSIís aspartame committee.
A spokesman for the NutraSweet Co. described Wurtmanís public attacks
as a "political issue," but declined to elaborate.
Wurtmanís relationship with Searle, The NutraSweet Co., and many of the
companies that sell NutraSweet-flavored products dates to 1978.
Beginning that year, according to public records, ILSI provided more
than $200,000. to finance his research on caffeine, a common beverage
ingredient that was under FDA scrutiny.
Wurtman said he found no ill health effects during his caffeine
research, and his relationship was "excellent" with ILSI ≠ a spinoff of
the National Soft Drink Association.
During the same period in 1978, he said he rejected a Searle offer of
financial support for research on amino acids. Phenylalanine and
aspartic acid, two such amino acids, are the main components of
NutraSweet.
He said Dr. Sanford Miller, chief of FDAís Bureau of Foods, later
sought his testimony before a 1980 Public Board of Inquiry because he
openly stated his belief that neither glutamate nor aspartic acid, a
similar compound to that in NutraSweet, would not cause brain damage.
Wurtman strongly defended aspartame at the hearing.
He said he did not focus on phenylalanine until about 1983, when he
learned the FDA was considering expanding use of the low-calorie
sweetener, approved two years earlier for dry foods, to include
carbonated soft drinks.
From his caffeine research, Wutman said, he was aware of the exploding
soft drink market and concluded "that the use of aspartame was going to
go up considerably."
"I was genuinely concerned that there might be an increase in brain
phenylalanine levels."
Wurtman said that, while phenyalanine is vital to the brain, it can
serve as a barrier to 20 other amino acids that provide protein.
At a meeting in July 1983, Wurtman said he told National Soft Drink
Association officials that "if you put large amounts of aspartame in
soft drinks and people drink as much as I think they will, there are
going to be problems."
Wurtman said that after the industry accepted his idea for combining
NutraSweet with saccharin to cut the danger level, he accepted a Searle
offer to serve as consultant and relations were "all very friendly and
chummy".
Wurtman said he became "convinced that these people really want to know
the extent to which their product may be a real problem".
Shortly after he took the consulting job, he began getting letters from
seizure victims who believed their problems stemmed from NutraSweet.
Wurtman said he when advised Dr. Gerald Gaull, Searle vice president
for nutrition and medical affairs, in the Spring of 1985 that he thought
there was a link, "there was a very rapid souring of their
relationship".
During a visit to his MIT laboratory, Wurtman said, Gaull asked him to
review a proposal for a seizure study by him and his collaborator,
Harvard University neurologist Donald Schomer. He charged that when he
advised Gaull the pair would seek funding from ILSI, Gaull "got very
angry" and said, "We (meaning Searle), are active members of the ILSI
and we will veto your study".
"I was incredulous that he would say it to me, and I was dumbfounded
that he would say it in front of a witness," Wurtman said.
Schomer said he did not recall the comment. Gaull said, "There is no
way that I can veto anything at ILSI," because Searle has only one of 12
votes on the ISLI aspartame committee. He did not deny making the
threat.
Wurtman charged that Gaull later advised ISLI that two company-funded
seizure studies already were under way, and the foundation declined to
approve Wurtmanís grant.
In July of 1985, Wurtman said, he and three other scientists who had
expressed concerns about NutraSweet were among a group invited to
Gaullís home in Northeast Harbor, Maine, for a two-day conference.
"I left there with the conclusion there was no way these people were
going to do an honest job in assessing the possibility that aspartame
contributed to seizures," Wurtman said.
He said he also was skeptical because, as a company consultant, Searle
had asked him to chair its scientific advisory committee, a role in
which the company could use his name to defend the integrity of its own
research. But, he said, Searle refused to let him see protocols and data
from its studies.
"They wanted the name, but not the reality," he said. Frustrated by
these developments, Wurtman said he wrote a letter to Robert Shapiro,
president of Searle and later of the NutraSweet Co.
"Dear Bob," the letter said, "I know youíll agree that my value to
SearleÖ derives in part from my telling the company some things that it
would rather not hearÖand then from helping the company to deal with
those things."
"One such thing is that some consumers may develop significant medical
symptoms after consuming very large amounts of aspartame, particularly
if they happen, concurrently, to be on a low-calorie, low-protein,
weight-reducing dietsÖ If Searle-supported studies are going to
contribute to our understanding of these people and their symptoms, then
the studies have to include them, and not be restricted to people who
have a can or two of soda per day."
He said Shapiro never answered the letter.
Wurtman said he resigned his consulting role a short time later and
rejected company efforts in the ensuing months to reinstate the
arrangement.
UPI Aspartame Report Greg Gordon Part 3
UPI REPORT PART 3:
Part 3:
Sweet Corporate Victories
by: Gregory Gordon
WASHINGTON (UPI) In October 1982, Sen. Howell Heflin, D-Ala, proposed
an obscure amendment altering the laws covering U.S. patent extensions,
a move affecting only one company and one product, the artificial
sweetener, aspartame.
Without mentioning aspartame, which is sold under the name NutraSweet,
the senate passed the amendment to the Orphan Drug Act, extending G.D.
Searle Co.ís domestic monopoly on aspartame sales for another five
years, 10 months, and 17 days.
"We think itís an excellent amendment," remarked Sen. Orrin Hatch, R-
Utah, wrapping up a five-minute discussion on the Senate floor.
When the House approved the same language a month later, it all but
cinched another $3.5 billion to $4 billion in revenues for the Chicago-
based, Searle.
It helped Searleís stockholders sell the companyís assets, including
its lucrative NutraSweet division and the two domestic use patents, for
$2.7 billion to the Monsanto Corp. in the summer of 1985.
Sponsors of the measure found their campaign committee, enriched.
Heflinís 1984 reelection committee received contributions totaling at
least $9,000. from Searleís top officers and its political action
committee, more than any others among a long list of Searle
beneficiaries in Congress, federal Election Committee records show.
Hatchís committee received at least $3,000. the records show.
Heflin defended his sponsorship of the measure, saying Searle had been
victimized by regulatory delays that ate up most of its 17-year patent.
But a spokesman for the U.S. Patent Office said Heflinís legislation
marked one of only a handful of instances in the last three decades in
which a companyís patent has been extended by a private bill in
Congress.
It also provided a glimpse of the adeptness with which Searle,
Monsanto, and their lobbyists have guided the artificial sweetener
through the obstacles of government regulatory bureaucracies to capture
big financial rewards.
Headed by Donald Rumsfeld, the former Ford White House Chief of Staff,
Searle repeatedly demonstrated its political acumen on other front, too,
in the years prior to the sale to Monsanto.
In 1981, the company overcame a controversy-snarled, eight year review
process to win Food and Drug Administration approval for NutraSweet.
In 1984, Searle parried an assault on the sweetenerís safety from
Arizona food scientist, Dr. Woodrow Monte after hiring Arizona Gov.
Bruce Babbittís former chief of staff as a lobbyist. Searle officers
passed along campaign contributions of $2,000. to a key lawmaker, and
the company soon had won passage of legislation crushing Monteís efforts
to force tough state restrictions on the sweetener.
"I don't know of any company that has apparently covered all of its
bases as well as has Searle," said Sen. Metzenbaum (D-Ohio). "Whether it
has to do with the scientists or lawyers, or non-profit institutions, or
universities, or whatever; in every instance, I have found that they
have expended their dollars very carefully and very wisely, but without
apparent restraint as to the amount."
Indeed, besides Searleís hiring of up to a dozen lobbyists, UPI traced
nearly $200,000. in federal campaign contributions between 1973 and 1986
from its officers and political action committee.
The political intervention in the patent process drew the ire of
several small companies seeking to enter the aspartame market,
triggering charges that a corporate giant benefited from unjustified or
preferential treatment.
"I think its obvious they (Searle officials) used political muscle,"
Alan Kligerman, president of Lactaid, Inc., a New Jersey diet food
manufacturer, said of the patent extension. He said his firm had been
interested in manufacturing aspartame until the patent was extended, but
"Searle was well wired in."
"It is possible that they (the Senate) did not know what they were
passing," he said. "I don't know how they got that through, except with
the right phone calls."
"I would not hesitate to say," Metzenbaum said, "that the manner in
which that five-year extension of the patent rights was put through on
the floor of the U.S. Senate was totally inappropriate."
"It should not have been without the entire body being advised that,
that issue was going to be on the floor of the Senate."
Metzenbaum said that the Senate has an "alert" system under which all
legislation is cleared with individual senators before it is brought to
the floor, but the system was bypassed.
Jerry Ray, a spokesman for Heflin, asserted the offices of key
senators, including Metzenbaum, approved the measure before it went to
the floor. But Ray offered no explanation for the failure to fully
disclose the contents and impact of the measure.
Ray quoted Heflin, Chairman of the Senate Ethics Committee, is saying
Searle representatives never mentioned campaign contributions in asking
him to sponsor the amendment.
Heflin said he has "supported all patent restoration bills" because
regulatory delays have created "a chronic problem" in which companies
get so little use out of their 17-year patents, they are reluctant to
put money into research.
Heflin said, in Searleís case, "almost 35 percent of the patent term
had been used on a long series of administrative hearings, trials, and
appeals (in) which, in the end, the corporation finally prevailed. To
not restore some of the patent term lost would unfairly penalize them."
G.D. Searle sought an extension of its patent on grounds that the Food
and Drug Administrationís handling of its aspartame approval petition
was "an unparalleled instance of unnecessary regulatory delay, which
worked a great injustice to Searle".
Critics argue that, to the contrary, the FDA suspended its 1974
approval allowing Searle to market the sweetener because of evidence the
companyís animal studies were flawed and the results were misrepresented
to the FDA in the early 1970's.
The evidence prompted FDA chief counsel Richard Merrill to ask the U.S.
Attorneyís office in Chicago to open a grand jury investigation into
possible fraud by the company. While a grand jury investigated similar
allegations related to Searle drug products, no such inquiry was ever
begun into the aspartame testing. But the FDA was concerned enough about
Searleís research to appoint two task forces, a university research
group, and a Public Board of Inquiry to review various studies.
In 1981, shortly after taking office, FDA commissioner Arthur Hull
Hayes, Jr. overturned the three-man Board of Inquiry and approved sale
of NutraSweet in dry foods. Two years later, Hayesí deputy, Mark
Novitch, approved the use of aspartame in soft drinks.
Kligerman dismissed as "crap" Searleís contention it had been
victimized by the FDA bureaucracy, which delayed a decision from 1975 to
1981.
"The FDA had reason for doing this," Kligerman said of the intense
review process. "It was not an unnecessary delay. It was Searleís fault
this happened."
For Purification Engineering, Inc. of Columbia, Md., which raised money
from private investors and built a plant solely to manufacture aspartame
for Searle, the congressional action ultimately turned out to be
devastating.
Gary Calton, a senior vice president for Purification Engineering, said
that on Jan. 4, 1985, Searle notified the firm its contract would not be
renewed. Seven months later, the firm was sold to Rhone-Poulenc Co., a
French firm.
"My company would have been worth a great deal more if it had not been
for that (patent) extension," Calton said. (Note: Searle sold The
NutraSweet Co. to Monsanto in 1985) Calling the action unfair, he said,
"I don't think Congress should go around passing laws making G.D. Searle
rich any more than they should go around making me rich."
Searle officials declined to discussed the patent extension, but a
company lobbyist, former White House official William Timmons, said the
company "felt there was an injustice" in the delays following
aspartameís 1974 approval. He said the company "took an advocacy role by
talking to a lot of members of Congress".
In May of 1984, FEC records show Heflinís reelection committee received
$1,000. donations from Daniel Searle, the chief executive officer of the
giant pharmaceutical company; his wife, Dain; William Searle, Searleís
brother who was a company director; William Searleís wife, Sally;
Suzanne Searle Dixon, a sister of the Searles; and her husband, Wesley
Dixon, who also was a company director.
Heflin also received $1,000. from William Searle prior to the general
election, and $2,000. in Searle PAC contributions, FEC records show.
On November 1982, a week after his reelection and a month after
praising the amendment in the Senate chambers, Hatchís committee
received $2,000. in contributions from top Searle officers, the records
show.
Sen. Robert Byrd (D-W.Va.), who brought the amendment up for a vote on
Heflinís behalf, also received a $1,000. campaign contribution from
Daniel Searle on Sept. 25, 1981.
Hatch received contributions of $1,000. each from Daniel Searle, Wesley
Dixon, and William Searle on Nov. 11, 1982, days after he was reelected
to a second term in which he continued as chairman of the Labor and
Human Resources Committee that oversees the FDA.
As chairman of the panel until last January, Hatch repeatedly blocked
Sen. Metzenbaumís calls for new hearings into the safety of NutraSweet.
Prior to his reelection, Hatch also received $2,500. in contributions
from the soft drink PAC.
Rep. Henry Waxman (D-Calif.), who sponsored the Orphan Drug Act
covering research for treating rare diseases and who carried Heflinís
patent amendment to the bill in the House, received $1,500. in campaign
contributions from the soft drink PAC, including $500. two days before
the measureís introduction in the House.
Like Heflin, Waxman made no mention of aspartame in describing the
Senate amendments to the drug act on the House floor.
Searle also flashed its political prowess after Arizona scientist
Woodrow Monte stirred up a furor in 1984 by publicly assailing
NutraSweetís safety.
The ensuing events, Monte charged, "reflected exactly what Searle has
been doing all along. Theyíve been buying their way into the hearts and
minds of America. They've been using their financial acumen to get their
way."
Within months, legislative rules were swept aside one day in early 1985
and, in a swift, subtle maneuver without notice to the public, Monteís
campaign for state regulations on the sweetener was sidetracked.
Monte was a leading national advocate in the drive to block marketing
of NutraSweet until his own credibility was damaged in 1984 with
disclosures he had invested in "put options" that would have earned
profits if Searleís stock dropped.
He now concedes his options trading was a mistake, but denies it
influenced his research.
Monte said he was convinced in 1983, when the FDA okayed use of
NutraSweet in carbonated beverages, that the sweetener would break down
into poisonous quantities of methyl alcohol in diet sodas left in the
Southwest sun.
Monte, director of the Food Science and Nutrition Laboratories at
Arizona State, and two consumer groups petitioned the Arizona Dept. of
Health Services to ban the sweetener.
Monte said his rat studies had shown that chronic ingestion of methyl
alcohol causes brain damage similar to that in humans suffering from
Multiple Sclerosis, including seizures, amnesia, optic neuritis,
numbness, and dizziness. In the desert heat, Monte said, methanol
degrades faster into toxic methyl alcohol.
Searle and FDA officials have argued that aspartame contains too little
methanol to pose a health hazard.
When Monte and the consumer groups pressed their legal challenge for
more than a year, Searle flexed its muscle: The company dispatched a
coterie of lobbyists to the state capitol, among them Andrew Hurwitz,
Gov. Babbittís former Chief of Staff; prominent Arizona lobbyist Charles
Pine; company lawyer Roger Thies, and another company official, David
West.
Between August 23, and Sept. 21, 1984 company officers Daniel Searle
and his brother-in-law, Wesley Dixon, each contributed $1,000. to the
campaign of State House Majority Leader Burton Barr, later a GOP
candidate for governor, reports to the Arizona Secretary of Stateís
office records show.
Campaign disclosure forms show revealed that, during the same period,
several House Republicans received contributions from the Committee to
reelect Barr, including State Reps. Don Aldridge, Karen Mills, and Jan
Brewer, all among the Health Committee members who voted 13-0 to pass
the measure affecting NutraSweet. The trio received $1,500., $1,000. and
$750. respectively from Barr, who for years has enhanced his influence
by donating to colleaguesí campaigns.
Barr and Arizona State University Regent William Reilly contacted the
schoolís president, J. Russell Nelson, and Academic Vice President Jack
Kinsinger to inquire into Monteís public attacks on NutraSweet,
published reports said. Kinsinger insisted that the issue caused no
delay in his decision to grant Monte tenure. Barr did not return phone
calls.
When Monteís first petition was rejected and he filed for
reconsideration, Hurwitz wrote a letter offering legal advice to the
Dept. of Health Services (DHS) about its response, and sent copies to
Barr and aides to Gov. Babbitt.
In April of 1985, about the same time Monte and his associates finally
were to be granted a hearing before the state agency on their petition,
they learned that the Arizona Legislature had used a rare maneuver to
change the law, without public notice to bar state regulation of FDA-
approved food additives. The measure passed under the misleading title
of a toxic waste bill.
Monteís campaign to ban NutraSweet in Arizona prompted the State Dept.
of Health Services to conduct a study to determine how much NutraSweet
soft drinks degraded in high-temperature conditions. The study,
completed in July 1984, found that methanol levels were highest (9.4
ppm), in Diet 7-Up samples stored the longest time in the warmest
temperature, 99? F heat.
Present and former Arizona state officials have told UPI that the study
concerned DHS officials enough that they discussed a NutraSweet ban.
But Norman Peterson, manager of the DHSís Office of Chronic Disease and
Environmental Health Services, said that the agency concluded that "the
FDA address the methyl alcohol question and had all sorts of supporting
data. We had no basis for saying that the data they had presented in
support was not correct or adequate."
Another source said Peterson was distressed enough that, during a
meeting attended by DHS director Donald Mathis, he proposed being
allowed to recommend that pregnant woman, and children, limit their
consumption of NutraSweet.
Peterson would not confirm the episode, but recalled that he "was upset
about the fact that there were so many unanswered questions".
Mathis, who since left the agency, said he was satisfied that it
"wouldn't be humanly possible" to ingest levels of NutraSweet that would
produce a toxic reaction.
In September 1984, Monte and his associates file suit to force the DHS
to impose storage and labeling requirements or ban NutraSweet
altogether. But a proposed settlement under which the agency would hold
a public hearing was scuttled because it lacked the approval of Mathisí
successor, Lloyd Novick.
After more negotiations, the DHS agreed to hold a hearing. But before
it could take place, the issue was killed by the legislative change.
House Speaker James Sossaman later admitted that the GOP-controlled
House violated its own rules in passing a so-called "strike all"
amendment. Chairman Bart Baker of the Health Committee engineered the
action, in which an existing bill was stripped, replaced with the
NutraSweet language and brought to a vote without the required 24 hours
public notice.
For Monte, the development was all the more staggering after he had
gotten into a jam over his stock purchase. Monte said that, after
reviewing files at the FDA and consulting with his lawyer in 1983, he
invested less than $2,000. on Searle options, hoping to raise money to
support his costly legal battles against the sweetener. He said he ended
up losing $1,224.
Lawyer Rick Faerber also invested in part, he said, because of Monteís
knowledge of an upcoming CBS story critical of the FDAís approval of
aspartame. He said stock analysts had phoned Monte inquiring about his
Arizona petitions and apparently got the idea the developments would
depress the stock value.
Faerber said he regrets telling Monte that he "didnít think there was
anything wrong" with investing, particularly because pro-NutraSweet
forces apparently learned of their dealings. CBS employees also bought
"put options" but a Securities and Exchange Commission investigation did
not lead to any charges.
Shortly after news stories about the investment appeared, Rep. Bob
McEwen, (R-Ohio), assailed CBS and Monte for "irresponsible reporting
and conflicts of interest" in a brief speech on the floor of the U.S.
Senate. McEwen charged that the "false report" about NutraSweet was
aired solely for profit.
But in his speech, Rep. McEwen did not mention that his top assistant
Charles Greener, is the son of William Greener, Jr., Searleís vice
president for corporate communications.
Charles Greener who said he was "unaware" of Rep. McEwenís floor speech
until after it occurred, said his father never has handled NutraSweet
matters and that McEwen did not know any Searle officials.
The success of the Searle family business, founded 80 years ago, is all
the more astounding when compared to the companyís predicament in 1977
when it plucked Rumsfeld as its president. Facing a company mired in
debt, Rumsfeld, a native Chicagoan and former Illinois congressman,
quickly hired three other outgoing Ford Administration officials to join
him.
As executive vice president, he named John Robson, a former partner in
the law firm of Sidley & Austin who had served as President Fordís
chairman of the Civil Aeronautics Board. Robert Shapiro, Robsonís
special assistant at the Transportation Department, was tapped as
general counsel. Rumsfeld also hired William Greener, Sr., who had been
a spokesman in the Ford White House and Rumsfeldís chief spokesman at
the Pentagon.
The pharmaceutical company suddenly was being run by lawyers and
politicians.
Stomaching a $28 million net loss in his first year, Rumsfeld slashed
Searleís operations, selling off more than 30 subsidiaries worth more
than $400 million.
Before Rumsfeld could mount a full scale effort to lift a FDA freeze on
the sale of NutraSweet, Searle was hit with serious new problems. Suits
filed on behalf of 780 women, alleged the companyís Copper 7
intrauterine device had caused them to develop pelvic inflammatory
disease, an infection of the reproductive tract that can lead to
sterility, even death.
Before the suits could be settled, Searle sold out to Monsanto.
The huge, St. Louis-based chemical company and its officers were
promptly met with stockholder suits alleging they had failed to explore
potential safety problems with Searleís biggest moneymakers- Copper 7
IUD and NutraSweet.
Rejecting criticism of the acquisition, Earl Harbison, Jr., executive
vice president of Monsanto and Chairman of the Board of its Searle
pharmaceutical subsidiary, said in October 1985, that Monsanto "studied
this situation (Copper 7 litigation) very closely prior to acquiring
Searle, including consultations with independent physicians".
"We satisfied ourselves with the safety and efficacy of the product," he
said.
Since then, Copper 7 has been pulled off the market. Some lawyers
likened the resulting legal morass to the failure of the Dalkon Shield
that drove the Richmond-based A.H. Robins Co. into Chapter 11 bankruptcy
protection.
But a former Monsanto official, who requested anonymity, said that as
part of the sale agreement, Searle set aside reserves to cover the IUD
lawsuits. Thanks to NutraSweet, Searle family members Daniel and William
Searle and their sister, Suzanne Searle Dixon, to date appear to have
walked away unscathed from all the crises and legal battles.
And even if NutraSweet were proved hazardous, the purchase agreement
provided "no escrow, reserve or holdback for liability stemming from the
potential health hazards attributed to the NutraSweet product line,"
says one lawsuit filed by Chicago lawyer Robert Holstein on behalf of a
Monsanto stockholder.
And Rumsfeld emerged from his nine years with the company in solid
financial condition. Securities and Exchange Commission records show
that for his guiding the sweeping turnaround, he earned more than $ 2
million in salaries and more than $1.5 million in bonuses between 1979
and 1984.
"Banana plants don't make NutraSweet," the television announcer noted
wryly, and the image of an exotic bird perched in a jungle tree filled
the screen.
"Neither do cows," said the voice, as the camera cut to a robust-
looking heifer wagging its tail. "But they might as well. If you've had
bananas and milk, you've eaten whatís in NutraSweet."
True, bananas, milk and NutraSweet all contain phenylalanine, one of 21
amino acids that form the "building blocks" of protein. But that doesnít
tell the whole story. Dr. Richard Wurtman, a neuroscientist at the
Massachusetts Institute of Technology, says that because NutraSweet
lacks other important amino acids normally found in foods, the brain
absorbs unusually high levels of phenylalanine that could increase the
likelihood of epileptic seizures.
Referring to an ad proclaiming that the body treats the ingredient of
the artificial sweetener "no differently than if they came from a peach
or a string bean or a glass of milk," Wurtman said, "Thatís not true."
Dr. Louis Elsas, director of medical genetics at Emory University,
groans at the industry arguments that eating or drinking NutraSweet
(aspartame) is just like eating a hamburger.
"Phenylalanine is a known toxin to the brain,í Elsas said. "Aspartame
is phenylalanine, and drinking aspartame is like drinking phenylalanine
as an individual amino acid."
A spokeswoman at the New York offices of Ogilvy and Mather, the lead ad
agency on the sweetener account for the Chicago-based NutraSweet Co.,
declined comment on the allegation. The drumbeat of NutraSweet
advertisements has been steady. Beverage Industry, a trade publication,
labeled the NutraSweet blitz "probably the largest advertising campaign
ever designed around a product ingredient."
Industry sources say that since 1984, The NutraSweet Co. alone has
spent $30 million to $40 million a year on advertising, and ads by diet
soft drink manufacturers and other companies, whoís products carry the
swirl trademark of the sugar-free sweetener, would easily send that the
figure past $100 million a year.
The campaign has worked to make NutraSweet a household word.
Football stars Joe Montana and Dan Marino and boxer Marvin Hagler have
pitched products containing the artificial sweetener on television.
Former Democratic vice presidential candidate Geraldine Ferraro has
appeared in advertisements endorsing a product containing NutraSweet, as
have numerous celebrities, including Bill Cosby, Raquel Welch and Billy
Crystal.
Part 3:
Sweet Corporate Victories
by: Gregory Gordon
WASHINGTON (UPI) In October 1982, Sen. Howell Heflin, D-Ala, proposed
an obscure amendment altering the laws covering U.S. patent extensions,
a move affecting only one company and one product, the artificial
sweetener, aspartame.
Without mentioning aspartame, which is sold under the name NutraSweet,
the senate passed the amendment to the Orphan Drug Act, extending G.D.
Searle Co.ís domestic monopoly on aspartame sales for another five
years, 10 months, and 17 days.
"We think itís an excellent amendment," remarked Sen. Orrin Hatch, R-
Utah, wrapping up a five-minute discussion on the Senate floor.
When the House approved the same language a month later, it all but
cinched another $3.5 billion to $4 billion in revenues for the Chicago-
based, Searle.
It helped Searleís stockholders sell the companyís assets, including
its lucrative NutraSweet division and the two domestic use patents, for
$2.7 billion to the Monsanto Corp. in the summer of 1985.
Sponsors of the measure found their campaign committee, enriched.
Heflinís 1984 reelection committee received contributions totaling at
least $9,000. from Searleís top officers and its political action
committee, more than any others among a long list of Searle
beneficiaries in Congress, federal Election Committee records show.
Hatchís committee received at least $3,000. the records show.
Heflin defended his sponsorship of the measure, saying Searle had been
victimized by regulatory delays that ate up most of its 17-year patent.
But a spokesman for the U.S. Patent Office said Heflinís legislation
marked one of only a handful of instances in the last three decades in
which a companyís patent has been extended by a private bill in
Congress.
It also provided a glimpse of the adeptness with which Searle,
Monsanto, and their lobbyists have guided the artificial sweetener
through the obstacles of government regulatory bureaucracies to capture
big financial rewards.
Headed by Donald Rumsfeld, the former Ford White House Chief of Staff,
Searle repeatedly demonstrated its political acumen on other front, too,
in the years prior to the sale to Monsanto.
In 1981, the company overcame a controversy-snarled, eight year review
process to win Food and Drug Administration approval for NutraSweet.
In 1984, Searle parried an assault on the sweetenerís safety from
Arizona food scientist, Dr. Woodrow Monte after hiring Arizona Gov.
Bruce Babbittís former chief of staff as a lobbyist. Searle officers
passed along campaign contributions of $2,000. to a key lawmaker, and
the company soon had won passage of legislation crushing Monteís efforts
to force tough state restrictions on the sweetener.
"I don't know of any company that has apparently covered all of its
bases as well as has Searle," said Sen. Metzenbaum (D-Ohio). "Whether it
has to do with the scientists or lawyers, or non-profit institutions, or
universities, or whatever; in every instance, I have found that they
have expended their dollars very carefully and very wisely, but without
apparent restraint as to the amount."
Indeed, besides Searleís hiring of up to a dozen lobbyists, UPI traced
nearly $200,000. in federal campaign contributions between 1973 and 1986
from its officers and political action committee.
The political intervention in the patent process drew the ire of
several small companies seeking to enter the aspartame market,
triggering charges that a corporate giant benefited from unjustified or
preferential treatment.
"I think its obvious they (Searle officials) used political muscle,"
Alan Kligerman, president of Lactaid, Inc., a New Jersey diet food
manufacturer, said of the patent extension. He said his firm had been
interested in manufacturing aspartame until the patent was extended, but
"Searle was well wired in."
"It is possible that they (the Senate) did not know what they were
passing," he said. "I don't know how they got that through, except with
the right phone calls."
"I would not hesitate to say," Metzenbaum said, "that the manner in
which that five-year extension of the patent rights was put through on
the floor of the U.S. Senate was totally inappropriate."
"It should not have been without the entire body being advised that,
that issue was going to be on the floor of the Senate."
Metzenbaum said that the Senate has an "alert" system under which all
legislation is cleared with individual senators before it is brought to
the floor, but the system was bypassed.
Jerry Ray, a spokesman for Heflin, asserted the offices of key
senators, including Metzenbaum, approved the measure before it went to
the floor. But Ray offered no explanation for the failure to fully
disclose the contents and impact of the measure.
Ray quoted Heflin, Chairman of the Senate Ethics Committee, is saying
Searle representatives never mentioned campaign contributions in asking
him to sponsor the amendment.
Heflin said he has "supported all patent restoration bills" because
regulatory delays have created "a chronic problem" in which companies
get so little use out of their 17-year patents, they are reluctant to
put money into research.
Heflin said, in Searleís case, "almost 35 percent of the patent term
had been used on a long series of administrative hearings, trials, and
appeals (in) which, in the end, the corporation finally prevailed. To
not restore some of the patent term lost would unfairly penalize them."
G.D. Searle sought an extension of its patent on grounds that the Food
and Drug Administrationís handling of its aspartame approval petition
was "an unparalleled instance of unnecessary regulatory delay, which
worked a great injustice to Searle".
Critics argue that, to the contrary, the FDA suspended its 1974
approval allowing Searle to market the sweetener because of evidence the
companyís animal studies were flawed and the results were misrepresented
to the FDA in the early 1970's.
The evidence prompted FDA chief counsel Richard Merrill to ask the U.S.
Attorneyís office in Chicago to open a grand jury investigation into
possible fraud by the company. While a grand jury investigated similar
allegations related to Searle drug products, no such inquiry was ever
begun into the aspartame testing. But the FDA was concerned enough about
Searleís research to appoint two task forces, a university research
group, and a Public Board of Inquiry to review various studies.
In 1981, shortly after taking office, FDA commissioner Arthur Hull
Hayes, Jr. overturned the three-man Board of Inquiry and approved sale
of NutraSweet in dry foods. Two years later, Hayesí deputy, Mark
Novitch, approved the use of aspartame in soft drinks.
Kligerman dismissed as "crap" Searleís contention it had been
victimized by the FDA bureaucracy, which delayed a decision from 1975 to
1981.
"The FDA had reason for doing this," Kligerman said of the intense
review process. "It was not an unnecessary delay. It was Searleís fault
this happened."
For Purification Engineering, Inc. of Columbia, Md., which raised money
from private investors and built a plant solely to manufacture aspartame
for Searle, the congressional action ultimately turned out to be
devastating.
Gary Calton, a senior vice president for Purification Engineering, said
that on Jan. 4, 1985, Searle notified the firm its contract would not be
renewed. Seven months later, the firm was sold to Rhone-Poulenc Co., a
French firm.
"My company would have been worth a great deal more if it had not been
for that (patent) extension," Calton said. (Note: Searle sold The
NutraSweet Co. to Monsanto in 1985) Calling the action unfair, he said,
"I don't think Congress should go around passing laws making G.D. Searle
rich any more than they should go around making me rich."
Searle officials declined to discussed the patent extension, but a
company lobbyist, former White House official William Timmons, said the
company "felt there was an injustice" in the delays following
aspartameís 1974 approval. He said the company "took an advocacy role by
talking to a lot of members of Congress".
In May of 1984, FEC records show Heflinís reelection committee received
$1,000. donations from Daniel Searle, the chief executive officer of the
giant pharmaceutical company; his wife, Dain; William Searle, Searleís
brother who was a company director; William Searleís wife, Sally;
Suzanne Searle Dixon, a sister of the Searles; and her husband, Wesley
Dixon, who also was a company director.
Heflin also received $1,000. from William Searle prior to the general
election, and $2,000. in Searle PAC contributions, FEC records show.
On November 1982, a week after his reelection and a month after
praising the amendment in the Senate chambers, Hatchís committee
received $2,000. in contributions from top Searle officers, the records
show.
Sen. Robert Byrd (D-W.Va.), who brought the amendment up for a vote on
Heflinís behalf, also received a $1,000. campaign contribution from
Daniel Searle on Sept. 25, 1981.
Hatch received contributions of $1,000. each from Daniel Searle, Wesley
Dixon, and William Searle on Nov. 11, 1982, days after he was reelected
to a second term in which he continued as chairman of the Labor and
Human Resources Committee that oversees the FDA.
As chairman of the panel until last January, Hatch repeatedly blocked
Sen. Metzenbaumís calls for new hearings into the safety of NutraSweet.
Prior to his reelection, Hatch also received $2,500. in contributions
from the soft drink PAC.
Rep. Henry Waxman (D-Calif.), who sponsored the Orphan Drug Act
covering research for treating rare diseases and who carried Heflinís
patent amendment to the bill in the House, received $1,500. in campaign
contributions from the soft drink PAC, including $500. two days before
the measureís introduction in the House.
Like Heflin, Waxman made no mention of aspartame in describing the
Senate amendments to the drug act on the House floor.
Searle also flashed its political prowess after Arizona scientist
Woodrow Monte stirred up a furor in 1984 by publicly assailing
NutraSweetís safety.
The ensuing events, Monte charged, "reflected exactly what Searle has
been doing all along. Theyíve been buying their way into the hearts and
minds of America. They've been using their financial acumen to get their
way."
Within months, legislative rules were swept aside one day in early 1985
and, in a swift, subtle maneuver without notice to the public, Monteís
campaign for state regulations on the sweetener was sidetracked.
Monte was a leading national advocate in the drive to block marketing
of NutraSweet until his own credibility was damaged in 1984 with
disclosures he had invested in "put options" that would have earned
profits if Searleís stock dropped.
He now concedes his options trading was a mistake, but denies it
influenced his research.
Monte said he was convinced in 1983, when the FDA okayed use of
NutraSweet in carbonated beverages, that the sweetener would break down
into poisonous quantities of methyl alcohol in diet sodas left in the
Southwest sun.
Monte, director of the Food Science and Nutrition Laboratories at
Arizona State, and two consumer groups petitioned the Arizona Dept. of
Health Services to ban the sweetener.
Monte said his rat studies had shown that chronic ingestion of methyl
alcohol causes brain damage similar to that in humans suffering from
Multiple Sclerosis, including seizures, amnesia, optic neuritis,
numbness, and dizziness. In the desert heat, Monte said, methanol
degrades faster into toxic methyl alcohol.
Searle and FDA officials have argued that aspartame contains too little
methanol to pose a health hazard.
When Monte and the consumer groups pressed their legal challenge for
more than a year, Searle flexed its muscle: The company dispatched a
coterie of lobbyists to the state capitol, among them Andrew Hurwitz,
Gov. Babbittís former Chief of Staff; prominent Arizona lobbyist Charles
Pine; company lawyer Roger Thies, and another company official, David
West.
Between August 23, and Sept. 21, 1984 company officers Daniel Searle
and his brother-in-law, Wesley Dixon, each contributed $1,000. to the
campaign of State House Majority Leader Burton Barr, later a GOP
candidate for governor, reports to the Arizona Secretary of Stateís
office records show.
Campaign disclosure forms show revealed that, during the same period,
several House Republicans received contributions from the Committee to
reelect Barr, including State Reps. Don Aldridge, Karen Mills, and Jan
Brewer, all among the Health Committee members who voted 13-0 to pass
the measure affecting NutraSweet. The trio received $1,500., $1,000. and
$750. respectively from Barr, who for years has enhanced his influence
by donating to colleaguesí campaigns.
Barr and Arizona State University Regent William Reilly contacted the
schoolís president, J. Russell Nelson, and Academic Vice President Jack
Kinsinger to inquire into Monteís public attacks on NutraSweet,
published reports said. Kinsinger insisted that the issue caused no
delay in his decision to grant Monte tenure. Barr did not return phone
calls.
When Monteís first petition was rejected and he filed for
reconsideration, Hurwitz wrote a letter offering legal advice to the
Dept. of Health Services (DHS) about its response, and sent copies to
Barr and aides to Gov. Babbitt.
In April of 1985, about the same time Monte and his associates finally
were to be granted a hearing before the state agency on their petition,
they learned that the Arizona Legislature had used a rare maneuver to
change the law, without public notice to bar state regulation of FDA-
approved food additives. The measure passed under the misleading title
of a toxic waste bill.
Monteís campaign to ban NutraSweet in Arizona prompted the State Dept.
of Health Services to conduct a study to determine how much NutraSweet
soft drinks degraded in high-temperature conditions. The study,
completed in July 1984, found that methanol levels were highest (9.4
ppm), in Diet 7-Up samples stored the longest time in the warmest
temperature, 99? F heat.
Present and former Arizona state officials have told UPI that the study
concerned DHS officials enough that they discussed a NutraSweet ban.
But Norman Peterson, manager of the DHSís Office of Chronic Disease and
Environmental Health Services, said that the agency concluded that "the
FDA address the methyl alcohol question and had all sorts of supporting
data. We had no basis for saying that the data they had presented in
support was not correct or adequate."
Another source said Peterson was distressed enough that, during a
meeting attended by DHS director Donald Mathis, he proposed being
allowed to recommend that pregnant woman, and children, limit their
consumption of NutraSweet.
Peterson would not confirm the episode, but recalled that he "was upset
about the fact that there were so many unanswered questions".
Mathis, who since left the agency, said he was satisfied that it
"wouldn't be humanly possible" to ingest levels of NutraSweet that would
produce a toxic reaction.
In September 1984, Monte and his associates file suit to force the DHS
to impose storage and labeling requirements or ban NutraSweet
altogether. But a proposed settlement under which the agency would hold
a public hearing was scuttled because it lacked the approval of Mathisí
successor, Lloyd Novick.
After more negotiations, the DHS agreed to hold a hearing. But before
it could take place, the issue was killed by the legislative change.
House Speaker James Sossaman later admitted that the GOP-controlled
House violated its own rules in passing a so-called "strike all"
amendment. Chairman Bart Baker of the Health Committee engineered the
action, in which an existing bill was stripped, replaced with the
NutraSweet language and brought to a vote without the required 24 hours
public notice.
For Monte, the development was all the more staggering after he had
gotten into a jam over his stock purchase. Monte said that, after
reviewing files at the FDA and consulting with his lawyer in 1983, he
invested less than $2,000. on Searle options, hoping to raise money to
support his costly legal battles against the sweetener. He said he ended
up losing $1,224.
Lawyer Rick Faerber also invested in part, he said, because of Monteís
knowledge of an upcoming CBS story critical of the FDAís approval of
aspartame. He said stock analysts had phoned Monte inquiring about his
Arizona petitions and apparently got the idea the developments would
depress the stock value.
Faerber said he regrets telling Monte that he "didnít think there was
anything wrong" with investing, particularly because pro-NutraSweet
forces apparently learned of their dealings. CBS employees also bought
"put options" but a Securities and Exchange Commission investigation did
not lead to any charges.
Shortly after news stories about the investment appeared, Rep. Bob
McEwen, (R-Ohio), assailed CBS and Monte for "irresponsible reporting
and conflicts of interest" in a brief speech on the floor of the U.S.
Senate. McEwen charged that the "false report" about NutraSweet was
aired solely for profit.
But in his speech, Rep. McEwen did not mention that his top assistant
Charles Greener, is the son of William Greener, Jr., Searleís vice
president for corporate communications.
Charles Greener who said he was "unaware" of Rep. McEwenís floor speech
until after it occurred, said his father never has handled NutraSweet
matters and that McEwen did not know any Searle officials.
The success of the Searle family business, founded 80 years ago, is all
the more astounding when compared to the companyís predicament in 1977
when it plucked Rumsfeld as its president. Facing a company mired in
debt, Rumsfeld, a native Chicagoan and former Illinois congressman,
quickly hired three other outgoing Ford Administration officials to join
him.
As executive vice president, he named John Robson, a former partner in
the law firm of Sidley & Austin who had served as President Fordís
chairman of the Civil Aeronautics Board. Robert Shapiro, Robsonís
special assistant at the Transportation Department, was tapped as
general counsel. Rumsfeld also hired William Greener, Sr., who had been
a spokesman in the Ford White House and Rumsfeldís chief spokesman at
the Pentagon.
The pharmaceutical company suddenly was being run by lawyers and
politicians.
Stomaching a $28 million net loss in his first year, Rumsfeld slashed
Searleís operations, selling off more than 30 subsidiaries worth more
than $400 million.
Before Rumsfeld could mount a full scale effort to lift a FDA freeze on
the sale of NutraSweet, Searle was hit with serious new problems. Suits
filed on behalf of 780 women, alleged the companyís Copper 7
intrauterine device had caused them to develop pelvic inflammatory
disease, an infection of the reproductive tract that can lead to
sterility, even death.
Before the suits could be settled, Searle sold out to Monsanto.
The huge, St. Louis-based chemical company and its officers were
promptly met with stockholder suits alleging they had failed to explore
potential safety problems with Searleís biggest moneymakers- Copper 7
IUD and NutraSweet.
Rejecting criticism of the acquisition, Earl Harbison, Jr., executive
vice president of Monsanto and Chairman of the Board of its Searle
pharmaceutical subsidiary, said in October 1985, that Monsanto "studied
this situation (Copper 7 litigation) very closely prior to acquiring
Searle, including consultations with independent physicians".
"We satisfied ourselves with the safety and efficacy of the product," he
said.
Since then, Copper 7 has been pulled off the market. Some lawyers
likened the resulting legal morass to the failure of the Dalkon Shield
that drove the Richmond-based A.H. Robins Co. into Chapter 11 bankruptcy
protection.
But a former Monsanto official, who requested anonymity, said that as
part of the sale agreement, Searle set aside reserves to cover the IUD
lawsuits. Thanks to NutraSweet, Searle family members Daniel and William
Searle and their sister, Suzanne Searle Dixon, to date appear to have
walked away unscathed from all the crises and legal battles.
And even if NutraSweet were proved hazardous, the purchase agreement
provided "no escrow, reserve or holdback for liability stemming from the
potential health hazards attributed to the NutraSweet product line,"
says one lawsuit filed by Chicago lawyer Robert Holstein on behalf of a
Monsanto stockholder.
And Rumsfeld emerged from his nine years with the company in solid
financial condition. Securities and Exchange Commission records show
that for his guiding the sweeping turnaround, he earned more than $ 2
million in salaries and more than $1.5 million in bonuses between 1979
and 1984.
"Banana plants don't make NutraSweet," the television announcer noted
wryly, and the image of an exotic bird perched in a jungle tree filled
the screen.
"Neither do cows," said the voice, as the camera cut to a robust-
looking heifer wagging its tail. "But they might as well. If you've had
bananas and milk, you've eaten whatís in NutraSweet."
True, bananas, milk and NutraSweet all contain phenylalanine, one of 21
amino acids that form the "building blocks" of protein. But that doesnít
tell the whole story. Dr. Richard Wurtman, a neuroscientist at the
Massachusetts Institute of Technology, says that because NutraSweet
lacks other important amino acids normally found in foods, the brain
absorbs unusually high levels of phenylalanine that could increase the
likelihood of epileptic seizures.
Referring to an ad proclaiming that the body treats the ingredient of
the artificial sweetener "no differently than if they came from a peach
or a string bean or a glass of milk," Wurtman said, "Thatís not true."
Dr. Louis Elsas, director of medical genetics at Emory University,
groans at the industry arguments that eating or drinking NutraSweet
(aspartame) is just like eating a hamburger.
"Phenylalanine is a known toxin to the brain,í Elsas said. "Aspartame
is phenylalanine, and drinking aspartame is like drinking phenylalanine
as an individual amino acid."
A spokeswoman at the New York offices of Ogilvy and Mather, the lead ad
agency on the sweetener account for the Chicago-based NutraSweet Co.,
declined comment on the allegation. The drumbeat of NutraSweet
advertisements has been steady. Beverage Industry, a trade publication,
labeled the NutraSweet blitz "probably the largest advertising campaign
ever designed around a product ingredient."
Industry sources say that since 1984, The NutraSweet Co. alone has
spent $30 million to $40 million a year on advertising, and ads by diet
soft drink manufacturers and other companies, whoís products carry the
swirl trademark of the sugar-free sweetener, would easily send that the
figure past $100 million a year.
The campaign has worked to make NutraSweet a household word.
Football stars Joe Montana and Dan Marino and boxer Marvin Hagler have
pitched products containing the artificial sweetener on television.
Former Democratic vice presidential candidate Geraldine Ferraro has
appeared in advertisements endorsing a product containing NutraSweet, as
have numerous celebrities, including Bill Cosby, Raquel Welch and Billy
Crystal.
