Mary Nash Stoddard's Blog, page 18
May 6, 2012
PILOTS and ASPARTAME (USAF/FAA/Department of Defense/Aspartame Pilot Hotline)
HARD COPY Expose PilotsLos Angeles, CA – October 26, 1996 – (ACSN) — Millions watched as Paramount Pictures' HARD COPY took on makers of Aspartame and the FDA, two days in a row the week of October 21st on national television. Anti-Aspartame Activists from Dallas based Aspartame Consumer Safety Network were featured.
Pilots with seizures from Aspartame (who lost their medical certification to fly) were seen telling the world about the 'Ticking Time Bomb' in the cockpit on every flight. In the form of Aspartame in sugarfree gums, breath mints, Equal, diet soft drinks, kool aid type drinks and foods laced with the sweetener, better known as NutraSweet, Equal, Spoonfuls, NatraSweet, Canderal, etc.
Two Commercial Airline Pilots talked about their frightening grand mal seizures. One in the cockpit, while in flight, making national headlines a few years back. Both lost 'medical certification to fly' as have dozens of others. They blame their medical problems on Aspartame. ACSN's Hotline also heard from other airline pilots who reported grand mal seizures in the cockpit in flight.
A huge audience watched incredulously as Senior NutraSweet Medical Consultant, Robert Moser, M.D., extolled the virtues of Aspartame for use by: 'children, pregnant women and lactating mothers.'
One interviewee, the mother of a four year old who died and was brought back to life in the ER, believes her daughter suffers irreparable brain damage from consumption of the sweetener in the form of children's vitamins.
James Sutton, 30 year old diabetic, described a debilitating stroke after heavy consumption of the sweetener. In the hospital, his doctor told him to 'stay away from it.'
Neurosurgeon/Author, Dr. Russell Blaylock, told of treating patients in his practice who have sustained serious neurological damage from their use of this 'Excitotoxin.'
University Professor, Jan Hull Smith, who suffered from Graves Disease after beginning to use the sweetener in shakes and soft drinks in lieu of meals, to lose a few pounds, was shown.
Following HARD COPY's exposé, email messages, phone calls, and frantic requests for further documentation flood Aspartame Consumer Safety Network's Dallas office. ACSN's website is getting hundreds of 'hits' from people searching for more information. Victims are stepping forward in record numbers with their 'horror stories.'
ACSN leaders salute HARD COPY for courage and foresight in airing this powerful story.
Pilots on AspartameInterview on WOR Radio NYCFollowing fr...
Pilots on Aspartame
Interview on WOR Radio NYC
Following from WOR Radio Dr. Robert Atkins Interview w/Mary Nash Stoddard:
All right, let's start taking calls you're on WOR, let's talk to Herb on Long Island.
Herb: Hello, Dr. Bob, I'd just like to relay a story about my daughter who just happened to be the first female jet pilot in the USAF. About five years ago, she came home on Thanksgiving weekend leave and she drank a lot of diet sodas. She had a bad spell here. A weak spell. But, when she got back to base, she went through a medical, and they determined that she had heart palpitations and arrhythmia.
Dr. Atkins : Were they alert to the possibility at this point in history, five years ago of diet sodas being the cause? Did they themselves think of diet sodas as the possible problem?
Herb: Yes. And, they determined that it might be the diet sodas and the artificial sweeteners.
Dr. Atkins: Mary, you should, take credit for that, I think. For giving that index of suspicion to everybody connected with caring for pilots that that is a possibility.
Mary : That's wonderful. We have done a lot of work with the FAA. Off the record, they are with us. But, on the record they can't say anything.
Herb: Also, in her group, in the Air Force, there were other pilots who were grounded because of heart problems. They discontinued using all their artificial sweeteners for one month and their flying status was restored to them. My daughter's retired now.
Dr. Atkins: Let's talk to Joy in New Jersey, Joy, you're on WOR.
Joy: Yes, good evening, Dr. Atkins and Ms. Stoddard. I experienced a severe problem with aspartame about ten years ago. I put it in my coffee. Within three minutes, I had such a headache I couldn't stand on my feet. I had palpitations and dizziness. I was deathly sick. I thought I was going to end up in the hospital. _____________
Interview on WOR Radio NYC
Following from WOR Radio Dr. Robert Atkins Interview w/Mary Nash Stoddard:
All right, let's start taking calls you're on WOR, let's talk to Herb on Long Island.
Herb: Hello, Dr. Bob, I'd just like to relay a story about my daughter who just happened to be the first female jet pilot in the USAF. About five years ago, she came home on Thanksgiving weekend leave and she drank a lot of diet sodas. She had a bad spell here. A weak spell. But, when she got back to base, she went through a medical, and they determined that she had heart palpitations and arrhythmia.
Dr. Atkins : Were they alert to the possibility at this point in history, five years ago of diet sodas being the cause? Did they themselves think of diet sodas as the possible problem?
Herb: Yes. And, they determined that it might be the diet sodas and the artificial sweeteners.
Dr. Atkins: Mary, you should, take credit for that, I think. For giving that index of suspicion to everybody connected with caring for pilots that that is a possibility.
Mary : That's wonderful. We have done a lot of work with the FAA. Off the record, they are with us. But, on the record they can't say anything.
Herb: Also, in her group, in the Air Force, there were other pilots who were grounded because of heart problems. They discontinued using all their artificial sweeteners for one month and their flying status was restored to them. My daughter's retired now.
Dr. Atkins: Let's talk to Joy in New Jersey, Joy, you're on WOR.
Joy: Yes, good evening, Dr. Atkins and Ms. Stoddard. I experienced a severe problem with aspartame about ten years ago. I put it in my coffee. Within three minutes, I had such a headache I couldn't stand on my feet. I had palpitations and dizziness. I was deathly sick. I thought I was going to end up in the hospital. _____________
May 5, 2012
Mary Nash Stoddard/author Deadly Deception Story of Aspartame Award from MEXICAN GOVERNMENT
En ESPAÑOLALERTA URGENTE A LOS CONSUMIDORES DE ASPARTAME
Los Traficantes de Drogas Legales – -El Secuestro de la Salud
Certificate Awarded at Puerto Vallarta Conference
• https://twitter.com/#!/marystod• http://www.aspartamesafety.com
• http://www.marystod.blogspot.com/
•http://www.goodreads.com/author_blog_posts/2119604-cancer-risks-from-aspartame-in-studies
Recent (2011-2012) Radio Interviews w/Mary S.:
•http://ppjg.me/2012/02/10/ts-radio-with-special-guest-mary-nash-stoddard-on-aspartame/
•http://www.blogtalkradio.com/theorganicview/2011/04/05/author-mary-nash-stoddard-deadly-deception-story-of-aspartame •<http://www.blogtalkradio.com/theorganicview/2011/04/05/author-mary-nash-stoddard-deadly-deception-story-of- aspartame>
•http://www.blogtalkradio.com/theorganicview/2012/01/18/mary-nash-stoddard-what-you-need-to-know-about-aspartame
VIDEOS on Youtube.com <http://Youtube.com> :
•http://www.doctoroz.com/videos/artificial-sweeteners-and-other-food-substitutes-dangerous-your-health
• http://www.youtube.com/watch?v=ELgW4KBY-o4
•http://www.youtube.com/watch?v=p2sVe8UIEhU&list=FLLJU6TCX2cZBOqgSQt0nBig&index=1&feature=plpp_video
•http://www.youtube.com/watch?v=LgBiw_Il5YM&list=PL816E179E4563EA4B&index=1&feature=plpp_video
• http://www.youtube.com/watch?v=2mVA03IzsFM&feature=related
• http://www.youtube.com/watch?v=I-vO8aY-I4Y&feature=related
• http://www.youtube.com/watch?v=hpoAtwVyzZI&feature=related
• http://www.youtube.com/watch?v=nzJ6ZbQN9mY&feature=endscreen
May 2, 2012
KIDNEY DAMAGE FROM ASPARTAME INGESTION (Scientific Studies/Data)
Damage to Kidneys, etc. from Methanol [wood alcohol]:
Renal changes [Table - 3] such as varying degrees of renal tubular degeneration (severe cloudy or vacuolar change) with patchy necrosis were seen in all the cases. Severe congestion of peritubular capillaries (71.42%), moderate glomerular capillary dilatation and congestion (78.57%), mild endothelial swelling (35.7%) and mild mesangial proliferation (35.7%) was the other significant renal findings.
Approximately 3-10% of administered dose of methanol is excreted unchanged by the kidneys[2]. Highest concentration of formaldehyde has been found in the kidney, liver and gastro-intestinal tract by studies using C[14] labelled methanol. Considering that both methanol and its toxic metabolites are concentrated in the kidneys it is not difficult to explain the severe degenerative changes in the renal tubules and peritubular capillaries. Glomerular changes too rescmble the early changes seen in cases of viper bites, Haemolytic uracmic syndrome and toxacmia of pregnancy, all of which have a known toxic aetiology.Thus changes in the various organs were probably of toxic aetiology, either mediated through the direct toxic action of the metabolite formaldehyde or the metabolic acidosis due to formic acid production.
:: References 1. Bade LK, Snore DP. Methyl alcohol poisoning, Medical News, Medicine and Law as quoted by Ravichandran et a1[8]. 1981; 12:106-108. 2. Barriers GR. Combustion of C[14] labeled methanol in intact rat and its isolated tissues. Amer J Physiol 1950; 163:614-618. 3. Bonnets IL Jr, Cony FH, Mitchell GL Jr, Cooper MN. Acute methyl alcohol poisoning: a review based on experiences in an outbreak of 323 cases. Medicine 1953; 32:431-463. 4. Gender A, Manly H, Churchill D, Hollomby D. Hemodialysis for methanol intoxication. Amer J Med 1978; 64:749-758. 5. Lurid A. Excretion of methanol and formic acid in man after methanol consumption. Quoted by Gender et al[4]. Acta Phamacol Toxicol 1948; 4:205. 6. Kaplan K. Methyl alcohol poisoning. Amer J Med Sci 1962; 244:170-174. 7. Orthner H. Die Methylalkohol vergiftung, as quoted by Gender er al[4]. Berlin: Springer Verlag; 1950. 8. Ravichandran R, Dudani RA, Alongside AE, Chamber KP, Acharya VN. Methyl alcohol poisoning (experience of an outbreak in Bombay). J Postgrad Med 1974; 30:69-74. 9. Zimmerman HJ, Ishak KG. In: Pathology of the Liver." MacSween RNM, Anthony PP, Pscheuer PJ, editors. 1st ed., Edinburgh: Churchill Livingstone; 1979, pp 337.
Below from FDA's Jerome Bressler Report:
ORGAN WEIGHTS
Organ Weights were entered on the gross pathology sheets at the time of autopsy. We compared all of the individual organ weights on appendix table 5 in the submission to FDA (Vol 1, pp. 222-226) with the original data on the gross pathology sheets. A total of eleven (11) errors were noted in transcribing the raw data from the pathology sheets, to the tables in the submission to FDA.
The errors are tabulated below:
Wt. Shown In Wt. Recorded on Animal No. Organ Submission Original Pathology Sheet
A12CM Kidneys 3.75 G 3.45 G L28LM Ven. Prostrate 747 mg. 474.7 mg. C0lMM Kidneys 9.40 G 9.219 G. C02HM Kidneys 1.46 G 4.259 G E14HM Kidneys 11.74 G 4.746 G J12HM Pituitary 3.0 mg. 3.3 mg. J30HM Ven. Prostrate 444 mg. 444.8 mg. F17CF Ovaries 36.7 mg. 233.5 & 36.7 mg. H30CF Liver 9.4 G 9.493 G B20HF Uterus 1115 mg. 1155 mg. K11HF Adrenals 799.1 mg. 797.1 mg._________________________________________________________________
NO evidence was obtained that any attempts were made to determine whether or not DKP could interfere with any of the clinical lab- oratory tests conducted. For that matter no information was made available to us as to whether DKP itself or related compounds did appear in the blood or the urine of rats fed diet containing this compound.
teletype sheets referred to previously. In reference to the low BUN values, Page 29 of the submission contains the following statement: "BUN" values for the control males at treatment day 189 were unusually low and may possibly be related to a technical artefact; as a result, the group mean values for all treated males at this interval were significantly higher but, in fact, these values were in the normal range. BUN values both in control and all treated male groups at treatment day 364 were unusually low; this again reflects a possible technical artefact."
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GROSS PATHOLOGY
The pathologists responsible for the microscopic examination (Rudolph Stejskal and Joseph smith) did not perform the necropsies. Necropsies were performed by Tony Martinez, David Kie and Robert Spaet, with the two pathologists avilable for consultation.
The submission to FDA (Vol 1, p. 7) reported that "Rats found dead during the study were autopsied immediately whenever possible. In cases where the ncropsy could not be performed promptly, the thoracic and abdominal cavities of dead rats were opened and the entire animal was immersed in neutral buffered formalin fixative for subsequent gross examination and dissection".
Our examination of gross pathology records showed that 98 of the 196 animals that died during the study were fixed in toto and autopsied at some later date, in some cases more than one year later.
A total of 20 animals were excluded from the study due to excessive autolysis. Of these, 17 had been fixed in toto and autopsied at a later date. Following are the twenty animals excluded from the study:
Animal No Date Found Dead Date Autopsied
C21CM 7/3/73 1/11/74 G16CM 9/21/73 1/11/74 G18CM 8/11/73 10/4/73 G26CM 4/2/73 1/11/74
J2CM 5/21/73 1/11/74 J5CM 10/30/72 11/8/72 L10CM 3/29/73 1/11/74 L15/CM 9/9/73 1/11/74 L21CM 4/13/73 1/11/74 L11LM 5/6/73 1/9/74 A14MM 5/21/73 1/9/74 G28MM 1/5/74 1/7/74 J25MM 5/24/73 5/24/73 A3HN 6/17/73 1/9/74 C15HM 1/7/74 1/7/74
(56)
Animal No Date Found Dead Date Autopsied
G13HM 7/25/73 **1/9/74 H24CF 4/29/73 1/11/74 D4HF 7/11/73 7/11/73 D16HF *4/2/73 1/8/74 F6HF 1/5/74 1/7/74
*Although the date found dead was listed as 4/12/73 on the gross pathology sheet, the "Tissue Masses & Deaths" book listed this date as 4/1/73.
**Although the date found dead was listed as 1/9/74 on the gross pathology sheet, the "Tissue Masses & Deaths" book listed this date as 7/25/73.
The gross pathology sheet for one of the above animals, F6HF, described a tissue mass measuring 5.0 X 4.5X2.5 cm. This tissue mass was first observed on 8/24/73 according to the pathology sheet (Exhibit #79), the observation records (Exhibit #70), and the palpation record in the "Tissue Masses and Deaths" book (Exhibit #65). The submission to FDA (Exhibit #8) reported no tissue mass and the animal was excluded from the study due to marked autolysis.
In addition to the above twenty animals that were excluded from the study, many other animals exhibited marked autolysis. For example, D27LF, M25CF, and H12CF are all described grossly in the submission to FDA as follows; "all organs examined grossly were markedly autolyzed".
Records for approximately 30 animals showed substantial differences between gross observations on pathology sheets, when compared with the individual pathology summaries submitted to FDA. Following is a detailed comparison of ten of these. (Copies of all the gross pathology sheets, and the pathology summaries submitted to FDA are attached as Exhibits #78, #79, and #86).
A2CM
Submission to FDA:
Lung - Focal adhesion Adrenal - Moderately enlarged
(57)
All other organs examined grossly were unremarkable.
Original Pathology Sheet:
Pituitary - Missing Lung - Left, mid-portion adheres to the medial area of the rib cage by a "fibrous" type of tissue. (Sub- mitted together with relevant portion of the rib cage).
Right, post-caval lobe has undergone consolidation. Contains grayish-yellowish nodules measuring 2 x 2 mm. (Entire lung submitted in toto)
Lymph NOdes, Pancreatic - Slightly enlarged
Adrenal - Left, moderately enlarged. Right and left, covered with tiny yellow spots measuring 1.0 x 1.0 mm.
Lymph Nodes, Mesenteric - moderately enlarged. Mass - previously described on 8/20/73 has since then regressed. Prostate - Marked atrophy, all lobes Seminal Vesicles - Marked atrophy, bilaterally
All other organs examined were grossly normal and unremarkable.
M15CF
Submission:
Mammary gland - subcutaneous mass located in mid-thoracic region measuring 7 x 6 x 2.5 cm.
Urinary bladder - papillary growth in the lumen.
All other organs examined grossly were unremarkable.
Original:
Mass #1 - Previously described in the left inguinal region on 2/9/73 has since then regressed.
(58)
Masses #2 and # - Located in the mid-axillary-cervical regions are all on mass now measuring 7.0 x 6.0 x 2.5 cm and may be described as irregular in shape, multi- nodular, smooth-surfaced, non-glistening, No Spinal Cord yellowish-purpulish in color, non-adherent to the VL underlying muscle and containing a whitish-yellowish firm tissue within. (Submitted in toto together with remainder of tissue).
Heart - Left Ventricle - dilitation and walls thin. Spleen - Slightly enlarged Liver - Prominent lobular architecture. Adrenal - Left, slightly enlarged. Right, unremarkable. Ovary - Right, small cyst measuring 4.0 x 4.0 mm and distended with a clear yellow fluid.
All other organs examined were grossly normal and unremarkable.
G10LM
Submission:
Testis - Marked atrophy, unilaterally. Kidney - Moderate enlargement, mottled appearance, bilaterally. Small and large intestine exhibited moderate autolysis, no sections submitted.
All other organs examined were grossly normal and unremarkable.
Original:
Mass which was initially palpated on 2/9/72 (86 days Rx) in the left inguinal area was actually the left testis which ascended and went thru weakened left inguinal ring into the subcutaneous area.
Testis - Left (ascended) appears atrophied (submitted in toto). Kidney - Moderate, diffuse and uniform enlargement, mottled, bilaterally (submitted in toto). Small and large intestines are moderately autolyzed (no sections submitted). Thyroid - Moderately enlarged, bilaterally. A 2 mm in dia., dis- crete, sl raised, moderately firm yellowish-grey lesion is located in the posterior tip, bilaterally. (Thyroid submitted in toto wrapped in a lens paper).
All other organs examined were grossly normal and unremarkable.
(59)
L11LM
Submission:
Kidney - Mottled appearance Testes - Marked atrophy, bilaterally Prostate - Marked atrophy
All other organs examined grossly exhibited marked autolysis.
Original:
Adrenal - Pale yellow, bilaterally Kidney - Pale yellow, bilaterally, rough-surfaced, bilaterally, moderately autolyzed, bilaterally, tiny spaces in the cortex region measuring about 1 mm in diameter, bilaterally. Testes - Marked atrophy, bilaterally, marked autolysis, bilaterally. Prostate - Marked atrophy, all lobes Seminal Vesicles - Marked atrophy, bilaterally Spleen - Marked autolysis Pancreas - Marked autolysis Stomach - Marked autolysis. A glandular portion - numerous, tiny, pitted ulcerations measuring 1 -4 mm in diameter. Lymph Nodes, Mesenteric - Marked autolysis Heart - Wall of left ventricle thin Brain - Marked autolysis Pituitary - Marked autolysis Liver - Marked autolysis
All other organs examined were grossly normal and unremarkable.
M17LF
Submission:
Pituitary - Marked enlargement. Adrenal - Markedly enlarged and hyperemic, bilaterally. Mammary Gland - Mass 1, located subcutaneously in left axillary region, measuring 3 X 3 X 2.5 cm; mass 2, located subcutaneously adjacent to mass 1, measuring 3 X 2 X 1 cm; mass 3, located subcutaneously in the right axillary region, measuring 2.5 X 2 X 1 cm; mass 4,
(60)
located subcutaneously in the left inguinal region, measuring 3 X 1 X 1 cm; mass 5, located subcutane- ously in the right inguinal region, measuring 2 X 1.5 X 1 cm.
All other organs examined grossly were unremarkable.
Original
Pit - appears markedly hyperemic Adrenal - Exhibits numerous minute greyish spots on the serosal surface bilaterally. It appears markedly enlarged.
Mass (1) - A 3 X 3 X 2.5 cm. spheroidal, multinodular, yellowish white, slightly firm mass located subcutaneously in the left axillary area. Mass non-adherent to the surrounding muscles or tissue (submitted in toto).
Mass (2) - A 2.5 X 2 X 1 cm spheroidal, smooth, yellowish white firm mass located subcutaneously and adjacent to the above described mass (submitted in toto) mass non- adherent to the surrounding muscles or tissues.
Mass (3) - A 2.3 X 2 X 1 cm. irregularly shaped, multinodular, yellowish white, firm mass located subcutaneously on the rt. axillary area. Mass non-adherent to the surrounding muscles or tissues (submitted in toto).
Mass (4) - A 3 X 1 X 1 cm. elongated, multinodular, yellowish white, firm mass located subcutaneously on the left inguinal area. Mass non-adherent to the surrounding muscles or tissues (submitted in toto).
Mass (5) - A 2 X 1.5 X 1 cm. flat, multinodular, yellowish white, firm mass located subcutaneously on the rt. inguinal area. Mass non-adherent to the surrounding muscles or tissues (submitted in toto).
All other organs examined were grossly normal and unremarkable.
C1MM
Submission
Kidney Marked enlargement with yellowish discoloration. Testis Marked atrophy, bilaterally.
(61)
Tissue mass located subcutaneously in the right inguinal area measuring 2.5 X 1 cm.
All other organs examined grossly were unremarkable.
Original:
Mass - Previously described on 12/9/72 and located subcutaneously in the right inguinal area now measures 2.5 X 2.0 X 1.0 cm and may be described as smooth-surfaced, purplish- yellowish in color, non-glistening, firm, multi-nodular, non-adherent to the underlying muscles and containing a firm yellowish-whitish tissue. (Submitted in toto together with a portion of the skin and underlying muscle with remainder of tissue). Heart - Left ventricle has undergone a moderate amount of dili- tation. Wall, left ventricle is thin. Liver - Prominent lobular architecture. Lung - Right, post-caval lobe-consolidation. Kidney - Markedly enlarged, yellow and rough-surfaced, bilaterally. Dilitation of the pelvis. Adrenal - Covered with tiny yellow spots measuring 1 mm in diameter, bilaterally.
Testes - Marked atrophy, bilaterally.
All other organs examined were grossly normal and unremarkable.
Tiss. Trimming - Nodules discovered immediately posterior (2.0 cm) to the pyloric portion of the stomach within the adipose tissue. Nodules may be described as firm, yellowish brownish in color. Non-glistening measuring 1.2 X 1.0 mm to 4.0 X 4.0 mm.
E27MM
Submission:
Lung - Moderate diffuse hyperemia. Eye - Opaque cornea, bilaterally.
All other organs examined grossly were unremarkable
Original:
Lungs - All lobes exhibit moderate diffuse and uniform hyperemia.
(62)
Kidney - Moderate autolysis. Eye - The entire cornea is opaque, bilaterally. Spleen - Moderately autolyzed. Stomach - Numerous 1-2 mm. hemorrhagic ulcerations are located on the glandular mucosa. Entire small and large intestines are moderately autolyzed. Brain & Pituitary - Moderately autolyzed.
All other organs examined were grossly normal and unremarkable.
A1HM
Submission:
All organs examined were grossly unremarkable.
Original:
Testes - Markedly atrophy, bilaterally Lung, Rt - Middle lobe exhibits a 1 X 1 cm consolidation on the posterior portion. Liver - All lobes appear olive green otherwise unremarkable.
All other organs examined were grossly normal and unremarkable.
L27HM:
Submission:
Testes - Right, slightly enlarged; left, mild atrophy.
All other organs examined grossly were unremarkable.
Original:
Testes - lt./appears markedly atrophy rt./appears to be distended with yellowish white substance
Seminal V- Appears markedly atrophy bilaterally. Intestinal - Large, markedly distended with "gas".
All other organs examined were grossly normal and unremarkable.
P.M. Testes - Also, small black areas are noted within along with the yellowish areas. Black areas measuring 1.0 X 1.0 to 4.0 X 4.0 mm in diameter.
(63)
J30HM
Submission:
Lung - Moderate consolidation of all right lobes. Testis - Moderate atrophy
All other organs examined grossly were unremarkable.
Original:
Pituitary - Markedly enlarged; slightly hyperemic. Heart - Left Ventricle has undergone dilitation walls thin. Lung - Right, anterior, medial and post-caval lobe have undergone consolidation. Testes - Marked atrophy, bilaterally.
Seminal Vesicle - Marked atrophy, bilaterally.
All other organs examined were grossly normal and unremarkable.
Dr. Stejskal told us that the other pathologist (Dr. Joseph Smith) who made microscopic evaluations of the slides, came from a hospital background (human pathology) and therefore his descriptions and terminology were a little bit different than one would expect from a veterinary pathologist.
MICROSCOPIC PATHOLOGY
We have assisted in our review of the Microscopic Pathology of Study E-77/78 by Charles H. Frith, D.V.M., Ph.D, Director, Pathology Services, NCTR. Dr. Frith arrived on 6/22/77 and spent 3 days with the FDA team. He examined slides for a representative number of animals, the selection of which was made jointly by Dr. Frith and the other members of the FDA team. A Searle Pathologist was not present during Dr. Frith's review of the slides. However, Dr. Frith did meet with Dr. Rudolf Stejskal, SEarle Pathologist, at the conclusion of this review and discussed some of his findings with him.
The first phase of Dr. Frith's review consisted of the examination of the tissues of 25 of the surviving control females and 11 of the non-surviving control females for a total of 36 animals. All of the slides were examined for each animal and the results were compared to the microscopic reports provided by Searle Laboratories. The inconsistencies (findings that differed from those reported by Searle) are listed below:
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In most cases the inconsistencies represent findings that were not diagnosed or reported by Searle. Copies of Searle's microscopic pathology reports for each of the animals listed below are attached as exhibit #60.
Female Rat No. F13CF (Path. No. 95617) Small Intestine - Diverticulum with mucosal necrosis and cellular inflammatory infiltrate.
Female Rat No. F15CF (Path No. 95618) Pancreas - Focal hyperplasia
Female Rat No. F16CF (Path No. 95619) Heart - Focal Fibrosis. Kidney - Mild chronic nephritis.
Female Rat No. H10CF (Path 95624) Ovary - Neoplasm - probably granulosa cell tumor.
Female Rat No. H19CF (Path. No. 95626) Kidney - Focal calcification. Ovary - Neoplasm - probably granulosa cell tumor.
Female Rat No. H30CF (Path. No. 95628) Kidney - Focal calcification.
Female Rat - No. K25CF (Path No. 95630) Kidney - Focal calcification.
Female Rat No. K29CF (Path No. 95631) Heart - Focal fibrosis Kidney - Focal calcification
Female Rat No. M4CF (Path No. 95632) Liver - Focal hyperplasia
Female Rat No. M10CF (Path No. 95634) Kidney - Focal calcification. Pituitary - Adenoma Ovary - Fibrosis and Pigmentation.
(65)
Female Rat No. M15CF (Path No. 95635) Pituitary - Adenoma. Ovary - Cyst.
Female Rat No. B30CF (Path No. 95801) Kidney - Focal calcification.
Female Rat D29CF (Path No. 95803) Urinary Bladder (1) Chronic diffuse inflammation. (2) Diffuse mild hyperplasia.
The second phase of the review consisted of the microscopic examination of all tissues from the high dose females - a total of 36 animals. The inconsistencies are listed below:
Female Rat No. B14HF (Path. No. 95657) Eye was reported as not examined but eye was present and normal.
Female Rat No. F25HF (Path. No. 95823) Urinary Bladder - Mild diffuse hyperplasia.
Female Rat No. H7HF (Path No. 95623) Ovary - Neoplasm - probably granulosa cell tumor.
Female Rat No. H9HF (Path No. 95665) Heart - Focal fibrosis. Urinary Bladder - Mild focal hyperplasia.
Female Rat No. H15HF (Path No. 95665) Lymph Node - The diagnosis of lymphoma, benign, was present on the Searle microscopic report. According to Dr. Frith, lymphoma is generally not considered to be benign and he would diagnose lympphosarcoma.
Female Rat NO. H18HF (Path No. 95667) Pituitary - Adenoma. Brain - Mild bilateral hydrocephalus.
Female Rat No. K18HF (Path No. 95824) Pituitary - Adenoma
Female Rat No. K24HF (Path. No. 95671) Mass noted grossly - nothing consistent with mass reported microscopically.
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Female Rat No. - M2HF (Path. No. 95672) Uterus - Chronic mild endometritis.
Female Rat No. M30HF (Path. No. 95343) Kidney - Focal calcification. Uterus - Chronic mild endometritis.
Female Rat No. M30HF (Path. No. 95675) Pancreas - Focal hyperplasia.
The third phase of this review consisted of microscopic verification of all masses reported grossly at necropsy from all female animals not examined in phases 1 and 2 and included a total of 73 animals. The inconsistencies are listed below:
Female Rat No. D10Lf (Path No. 92521) Subcutaneous mass was diagnosed as an angiofibroma on Searle report. The lesion is more consistent with an angiosarcoma.
Female Rat No. K9MF (Path. No. 95707) Uterus - Polyp.
Female Rat No. M1LF (Path. No. 95844) Tissue mass seen grossly was reported as missing and not available for microscopic examination. The tissue was present and was a mammary fibroadenoma.
In summary, Dr. Frith reviewed:
1) All 36 high dose females (all slides) including 3 that had been excluded from the study due to autolysis.
2) 36 (one-half) of the control females (all slides) including 1 animal that had been excluded from the study due to auto- lysis.
3) Remaining 73 female animals with grossly observed masses. (sufficient slides were reviewed to substantiate the masses)
4) 5 additional animals selected by the investigators (A1HM, A9HM, A29HM, C2CM, C24HM).
(67)
The slides reviewed in the first two categories above constituted 20% of the total animals on the study. Dr. Frith reviewed these slides blindly and then compared his findings with the Searle microscopic reports. According to Dr. Frith, his findings were in agreement with those of SEarle, for the most part. In his opinion, some of the lesions that he reported as inconsistencies were small, and might be considered insignificant by some pathologists. Dr. Frith did feel, however, that the ovarian neoplasms (animals H10CF, H19CF, and H7HP, and chronic cystitis and diffuse hyperplasia (animal D29CF) should have been reported..
Dr. Frith also considered two other discrepancies to be significant. They were:
1) The reporting of a mass (by Searle) as missing which was actually present (MlLF).
2) The finding of a polyp of the uterus which was not diagnosed by Searle (K9MF)
The second of the above two discrepancies assumes even more significance in view of the following:
The Histopathologic Summary table (table 11) in Volume I of the submission to FDA lists the following incidence of Uterine Polyps on page 87:
Incidence of Uterine Polyps
Controls Low Medium High 1 of 69 1 of 34 4 of 34 6 of 33 (1%) (3%) (12%) (18%)
The finding of one additional uterine polyp by Dr. Frith (in animal K9MF) increases the incidence in the mid dose to 5 of 34 (15%).
On page 82 of Volume I of the submission to FDA, is the statement: "other sporadic findings is included endometrial hyperplasia, polyp, cyst, congestion and squamous metaplasia." The term "sporadic findings" was used to characterize the incidence of uterine polyps, in spite of the fact that Searle had done a statistical analysis of these findings.
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Renal changes [Table - 3] such as varying degrees of renal tubular degeneration (severe cloudy or vacuolar change) with patchy necrosis were seen in all the cases. Severe congestion of peritubular capillaries (71.42%), moderate glomerular capillary dilatation and congestion (78.57%), mild endothelial swelling (35.7%) and mild mesangial proliferation (35.7%) was the other significant renal findings.
Approximately 3-10% of administered dose of methanol is excreted unchanged by the kidneys[2]. Highest concentration of formaldehyde has been found in the kidney, liver and gastro-intestinal tract by studies using C[14] labelled methanol. Considering that both methanol and its toxic metabolites are concentrated in the kidneys it is not difficult to explain the severe degenerative changes in the renal tubules and peritubular capillaries. Glomerular changes too rescmble the early changes seen in cases of viper bites, Haemolytic uracmic syndrome and toxacmia of pregnancy, all of which have a known toxic aetiology.Thus changes in the various organs were probably of toxic aetiology, either mediated through the direct toxic action of the metabolite formaldehyde or the metabolic acidosis due to formic acid production.
:: References 1. Bade LK, Snore DP. Methyl alcohol poisoning, Medical News, Medicine and Law as quoted by Ravichandran et a1[8]. 1981; 12:106-108. 2. Barriers GR. Combustion of C[14] labeled methanol in intact rat and its isolated tissues. Amer J Physiol 1950; 163:614-618. 3. Bonnets IL Jr, Cony FH, Mitchell GL Jr, Cooper MN. Acute methyl alcohol poisoning: a review based on experiences in an outbreak of 323 cases. Medicine 1953; 32:431-463. 4. Gender A, Manly H, Churchill D, Hollomby D. Hemodialysis for methanol intoxication. Amer J Med 1978; 64:749-758. 5. Lurid A. Excretion of methanol and formic acid in man after methanol consumption. Quoted by Gender et al[4]. Acta Phamacol Toxicol 1948; 4:205. 6. Kaplan K. Methyl alcohol poisoning. Amer J Med Sci 1962; 244:170-174. 7. Orthner H. Die Methylalkohol vergiftung, as quoted by Gender er al[4]. Berlin: Springer Verlag; 1950. 8. Ravichandran R, Dudani RA, Alongside AE, Chamber KP, Acharya VN. Methyl alcohol poisoning (experience of an outbreak in Bombay). J Postgrad Med 1974; 30:69-74. 9. Zimmerman HJ, Ishak KG. In: Pathology of the Liver." MacSween RNM, Anthony PP, Pscheuer PJ, editors. 1st ed., Edinburgh: Churchill Livingstone; 1979, pp 337.
Below from FDA's Jerome Bressler Report:
ORGAN WEIGHTS
Organ Weights were entered on the gross pathology sheets at the time of autopsy. We compared all of the individual organ weights on appendix table 5 in the submission to FDA (Vol 1, pp. 222-226) with the original data on the gross pathology sheets. A total of eleven (11) errors were noted in transcribing the raw data from the pathology sheets, to the tables in the submission to FDA.
The errors are tabulated below:
Wt. Shown In Wt. Recorded on Animal No. Organ Submission Original Pathology Sheet
A12CM Kidneys 3.75 G 3.45 G L28LM Ven. Prostrate 747 mg. 474.7 mg. C0lMM Kidneys 9.40 G 9.219 G. C02HM Kidneys 1.46 G 4.259 G E14HM Kidneys 11.74 G 4.746 G J12HM Pituitary 3.0 mg. 3.3 mg. J30HM Ven. Prostrate 444 mg. 444.8 mg. F17CF Ovaries 36.7 mg. 233.5 & 36.7 mg. H30CF Liver 9.4 G 9.493 G B20HF Uterus 1115 mg. 1155 mg. K11HF Adrenals 799.1 mg. 797.1 mg._________________________________________________________________
NO evidence was obtained that any attempts were made to determine whether or not DKP could interfere with any of the clinical lab- oratory tests conducted. For that matter no information was made available to us as to whether DKP itself or related compounds did appear in the blood or the urine of rats fed diet containing this compound.
teletype sheets referred to previously. In reference to the low BUN values, Page 29 of the submission contains the following statement: "BUN" values for the control males at treatment day 189 were unusually low and may possibly be related to a technical artefact; as a result, the group mean values for all treated males at this interval were significantly higher but, in fact, these values were in the normal range. BUN values both in control and all treated male groups at treatment day 364 were unusually low; this again reflects a possible technical artefact."
(55)
GROSS PATHOLOGY
The pathologists responsible for the microscopic examination (Rudolph Stejskal and Joseph smith) did not perform the necropsies. Necropsies were performed by Tony Martinez, David Kie and Robert Spaet, with the two pathologists avilable for consultation.
The submission to FDA (Vol 1, p. 7) reported that "Rats found dead during the study were autopsied immediately whenever possible. In cases where the ncropsy could not be performed promptly, the thoracic and abdominal cavities of dead rats were opened and the entire animal was immersed in neutral buffered formalin fixative for subsequent gross examination and dissection".
Our examination of gross pathology records showed that 98 of the 196 animals that died during the study were fixed in toto and autopsied at some later date, in some cases more than one year later.
A total of 20 animals were excluded from the study due to excessive autolysis. Of these, 17 had been fixed in toto and autopsied at a later date. Following are the twenty animals excluded from the study:
Animal No Date Found Dead Date Autopsied
C21CM 7/3/73 1/11/74 G16CM 9/21/73 1/11/74 G18CM 8/11/73 10/4/73 G26CM 4/2/73 1/11/74
J2CM 5/21/73 1/11/74 J5CM 10/30/72 11/8/72 L10CM 3/29/73 1/11/74 L15/CM 9/9/73 1/11/74 L21CM 4/13/73 1/11/74 L11LM 5/6/73 1/9/74 A14MM 5/21/73 1/9/74 G28MM 1/5/74 1/7/74 J25MM 5/24/73 5/24/73 A3HN 6/17/73 1/9/74 C15HM 1/7/74 1/7/74
(56)
Animal No Date Found Dead Date Autopsied
G13HM 7/25/73 **1/9/74 H24CF 4/29/73 1/11/74 D4HF 7/11/73 7/11/73 D16HF *4/2/73 1/8/74 F6HF 1/5/74 1/7/74
*Although the date found dead was listed as 4/12/73 on the gross pathology sheet, the "Tissue Masses & Deaths" book listed this date as 4/1/73.
**Although the date found dead was listed as 1/9/74 on the gross pathology sheet, the "Tissue Masses & Deaths" book listed this date as 7/25/73.
The gross pathology sheet for one of the above animals, F6HF, described a tissue mass measuring 5.0 X 4.5X2.5 cm. This tissue mass was first observed on 8/24/73 according to the pathology sheet (Exhibit #79), the observation records (Exhibit #70), and the palpation record in the "Tissue Masses and Deaths" book (Exhibit #65). The submission to FDA (Exhibit #8) reported no tissue mass and the animal was excluded from the study due to marked autolysis.
In addition to the above twenty animals that were excluded from the study, many other animals exhibited marked autolysis. For example, D27LF, M25CF, and H12CF are all described grossly in the submission to FDA as follows; "all organs examined grossly were markedly autolyzed".
Records for approximately 30 animals showed substantial differences between gross observations on pathology sheets, when compared with the individual pathology summaries submitted to FDA. Following is a detailed comparison of ten of these. (Copies of all the gross pathology sheets, and the pathology summaries submitted to FDA are attached as Exhibits #78, #79, and #86).
A2CM
Submission to FDA:
Lung - Focal adhesion Adrenal - Moderately enlarged
(57)
All other organs examined grossly were unremarkable.
Original Pathology Sheet:
Pituitary - Missing Lung - Left, mid-portion adheres to the medial area of the rib cage by a "fibrous" type of tissue. (Sub- mitted together with relevant portion of the rib cage).
Right, post-caval lobe has undergone consolidation. Contains grayish-yellowish nodules measuring 2 x 2 mm. (Entire lung submitted in toto)
Lymph NOdes, Pancreatic - Slightly enlarged
Adrenal - Left, moderately enlarged. Right and left, covered with tiny yellow spots measuring 1.0 x 1.0 mm.
Lymph Nodes, Mesenteric - moderately enlarged. Mass - previously described on 8/20/73 has since then regressed. Prostate - Marked atrophy, all lobes Seminal Vesicles - Marked atrophy, bilaterally
All other organs examined were grossly normal and unremarkable.
M15CF
Submission:
Mammary gland - subcutaneous mass located in mid-thoracic region measuring 7 x 6 x 2.5 cm.
Urinary bladder - papillary growth in the lumen.
All other organs examined grossly were unremarkable.
Original:
Mass #1 - Previously described in the left inguinal region on 2/9/73 has since then regressed.
(58)
Masses #2 and # - Located in the mid-axillary-cervical regions are all on mass now measuring 7.0 x 6.0 x 2.5 cm and may be described as irregular in shape, multi- nodular, smooth-surfaced, non-glistening, No Spinal Cord yellowish-purpulish in color, non-adherent to the VL underlying muscle and containing a whitish-yellowish firm tissue within. (Submitted in toto together with remainder of tissue).
Heart - Left Ventricle - dilitation and walls thin. Spleen - Slightly enlarged Liver - Prominent lobular architecture. Adrenal - Left, slightly enlarged. Right, unremarkable. Ovary - Right, small cyst measuring 4.0 x 4.0 mm and distended with a clear yellow fluid.
All other organs examined were grossly normal and unremarkable.
G10LM
Submission:
Testis - Marked atrophy, unilaterally. Kidney - Moderate enlargement, mottled appearance, bilaterally. Small and large intestine exhibited moderate autolysis, no sections submitted.
All other organs examined were grossly normal and unremarkable.
Original:
Mass which was initially palpated on 2/9/72 (86 days Rx) in the left inguinal area was actually the left testis which ascended and went thru weakened left inguinal ring into the subcutaneous area.
Testis - Left (ascended) appears atrophied (submitted in toto). Kidney - Moderate, diffuse and uniform enlargement, mottled, bilaterally (submitted in toto). Small and large intestines are moderately autolyzed (no sections submitted). Thyroid - Moderately enlarged, bilaterally. A 2 mm in dia., dis- crete, sl raised, moderately firm yellowish-grey lesion is located in the posterior tip, bilaterally. (Thyroid submitted in toto wrapped in a lens paper).
All other organs examined were grossly normal and unremarkable.
(59)
L11LM
Submission:
Kidney - Mottled appearance Testes - Marked atrophy, bilaterally Prostate - Marked atrophy
All other organs examined grossly exhibited marked autolysis.
Original:
Adrenal - Pale yellow, bilaterally Kidney - Pale yellow, bilaterally, rough-surfaced, bilaterally, moderately autolyzed, bilaterally, tiny spaces in the cortex region measuring about 1 mm in diameter, bilaterally. Testes - Marked atrophy, bilaterally, marked autolysis, bilaterally. Prostate - Marked atrophy, all lobes Seminal Vesicles - Marked atrophy, bilaterally Spleen - Marked autolysis Pancreas - Marked autolysis Stomach - Marked autolysis. A glandular portion - numerous, tiny, pitted ulcerations measuring 1 -4 mm in diameter. Lymph Nodes, Mesenteric - Marked autolysis Heart - Wall of left ventricle thin Brain - Marked autolysis Pituitary - Marked autolysis Liver - Marked autolysis
All other organs examined were grossly normal and unremarkable.
M17LF
Submission:
Pituitary - Marked enlargement. Adrenal - Markedly enlarged and hyperemic, bilaterally. Mammary Gland - Mass 1, located subcutaneously in left axillary region, measuring 3 X 3 X 2.5 cm; mass 2, located subcutaneously adjacent to mass 1, measuring 3 X 2 X 1 cm; mass 3, located subcutaneously in the right axillary region, measuring 2.5 X 2 X 1 cm; mass 4,
(60)
located subcutaneously in the left inguinal region, measuring 3 X 1 X 1 cm; mass 5, located subcutane- ously in the right inguinal region, measuring 2 X 1.5 X 1 cm.
All other organs examined grossly were unremarkable.
Original
Pit - appears markedly hyperemic Adrenal - Exhibits numerous minute greyish spots on the serosal surface bilaterally. It appears markedly enlarged.
Mass (1) - A 3 X 3 X 2.5 cm. spheroidal, multinodular, yellowish white, slightly firm mass located subcutaneously in the left axillary area. Mass non-adherent to the surrounding muscles or tissue (submitted in toto).
Mass (2) - A 2.5 X 2 X 1 cm spheroidal, smooth, yellowish white firm mass located subcutaneously and adjacent to the above described mass (submitted in toto) mass non- adherent to the surrounding muscles or tissues.
Mass (3) - A 2.3 X 2 X 1 cm. irregularly shaped, multinodular, yellowish white, firm mass located subcutaneously on the rt. axillary area. Mass non-adherent to the surrounding muscles or tissues (submitted in toto).
Mass (4) - A 3 X 1 X 1 cm. elongated, multinodular, yellowish white, firm mass located subcutaneously on the left inguinal area. Mass non-adherent to the surrounding muscles or tissues (submitted in toto).
Mass (5) - A 2 X 1.5 X 1 cm. flat, multinodular, yellowish white, firm mass located subcutaneously on the rt. inguinal area. Mass non-adherent to the surrounding muscles or tissues (submitted in toto).
All other organs examined were grossly normal and unremarkable.
C1MM
Submission
Kidney Marked enlargement with yellowish discoloration. Testis Marked atrophy, bilaterally.
(61)
Tissue mass located subcutaneously in the right inguinal area measuring 2.5 X 1 cm.
All other organs examined grossly were unremarkable.
Original:
Mass - Previously described on 12/9/72 and located subcutaneously in the right inguinal area now measures 2.5 X 2.0 X 1.0 cm and may be described as smooth-surfaced, purplish- yellowish in color, non-glistening, firm, multi-nodular, non-adherent to the underlying muscles and containing a firm yellowish-whitish tissue. (Submitted in toto together with a portion of the skin and underlying muscle with remainder of tissue). Heart - Left ventricle has undergone a moderate amount of dili- tation. Wall, left ventricle is thin. Liver - Prominent lobular architecture. Lung - Right, post-caval lobe-consolidation. Kidney - Markedly enlarged, yellow and rough-surfaced, bilaterally. Dilitation of the pelvis. Adrenal - Covered with tiny yellow spots measuring 1 mm in diameter, bilaterally.
Testes - Marked atrophy, bilaterally.
All other organs examined were grossly normal and unremarkable.
Tiss. Trimming - Nodules discovered immediately posterior (2.0 cm) to the pyloric portion of the stomach within the adipose tissue. Nodules may be described as firm, yellowish brownish in color. Non-glistening measuring 1.2 X 1.0 mm to 4.0 X 4.0 mm.
E27MM
Submission:
Lung - Moderate diffuse hyperemia. Eye - Opaque cornea, bilaterally.
All other organs examined grossly were unremarkable
Original:
Lungs - All lobes exhibit moderate diffuse and uniform hyperemia.
(62)
Kidney - Moderate autolysis. Eye - The entire cornea is opaque, bilaterally. Spleen - Moderately autolyzed. Stomach - Numerous 1-2 mm. hemorrhagic ulcerations are located on the glandular mucosa. Entire small and large intestines are moderately autolyzed. Brain & Pituitary - Moderately autolyzed.
All other organs examined were grossly normal and unremarkable.
A1HM
Submission:
All organs examined were grossly unremarkable.
Original:
Testes - Markedly atrophy, bilaterally Lung, Rt - Middle lobe exhibits a 1 X 1 cm consolidation on the posterior portion. Liver - All lobes appear olive green otherwise unremarkable.
All other organs examined were grossly normal and unremarkable.
L27HM:
Submission:
Testes - Right, slightly enlarged; left, mild atrophy.
All other organs examined grossly were unremarkable.
Original:
Testes - lt./appears markedly atrophy rt./appears to be distended with yellowish white substance
Seminal V- Appears markedly atrophy bilaterally. Intestinal - Large, markedly distended with "gas".
All other organs examined were grossly normal and unremarkable.
P.M. Testes - Also, small black areas are noted within along with the yellowish areas. Black areas measuring 1.0 X 1.0 to 4.0 X 4.0 mm in diameter.
(63)
J30HM
Submission:
Lung - Moderate consolidation of all right lobes. Testis - Moderate atrophy
All other organs examined grossly were unremarkable.
Original:
Pituitary - Markedly enlarged; slightly hyperemic. Heart - Left Ventricle has undergone dilitation walls thin. Lung - Right, anterior, medial and post-caval lobe have undergone consolidation. Testes - Marked atrophy, bilaterally.
Seminal Vesicle - Marked atrophy, bilaterally.
All other organs examined were grossly normal and unremarkable.
Dr. Stejskal told us that the other pathologist (Dr. Joseph Smith) who made microscopic evaluations of the slides, came from a hospital background (human pathology) and therefore his descriptions and terminology were a little bit different than one would expect from a veterinary pathologist.
MICROSCOPIC PATHOLOGY
We have assisted in our review of the Microscopic Pathology of Study E-77/78 by Charles H. Frith, D.V.M., Ph.D, Director, Pathology Services, NCTR. Dr. Frith arrived on 6/22/77 and spent 3 days with the FDA team. He examined slides for a representative number of animals, the selection of which was made jointly by Dr. Frith and the other members of the FDA team. A Searle Pathologist was not present during Dr. Frith's review of the slides. However, Dr. Frith did meet with Dr. Rudolf Stejskal, SEarle Pathologist, at the conclusion of this review and discussed some of his findings with him.
The first phase of Dr. Frith's review consisted of the examination of the tissues of 25 of the surviving control females and 11 of the non-surviving control females for a total of 36 animals. All of the slides were examined for each animal and the results were compared to the microscopic reports provided by Searle Laboratories. The inconsistencies (findings that differed from those reported by Searle) are listed below:
(64)
In most cases the inconsistencies represent findings that were not diagnosed or reported by Searle. Copies of Searle's microscopic pathology reports for each of the animals listed below are attached as exhibit #60.
Female Rat No. F13CF (Path. No. 95617) Small Intestine - Diverticulum with mucosal necrosis and cellular inflammatory infiltrate.
Female Rat No. F15CF (Path No. 95618) Pancreas - Focal hyperplasia
Female Rat No. F16CF (Path No. 95619) Heart - Focal Fibrosis. Kidney - Mild chronic nephritis.
Female Rat No. H10CF (Path 95624) Ovary - Neoplasm - probably granulosa cell tumor.
Female Rat No. H19CF (Path. No. 95626) Kidney - Focal calcification. Ovary - Neoplasm - probably granulosa cell tumor.
Female Rat No. H30CF (Path. No. 95628) Kidney - Focal calcification.
Female Rat - No. K25CF (Path No. 95630) Kidney - Focal calcification.
Female Rat No. K29CF (Path No. 95631) Heart - Focal fibrosis Kidney - Focal calcification
Female Rat No. M4CF (Path No. 95632) Liver - Focal hyperplasia
Female Rat No. M10CF (Path No. 95634) Kidney - Focal calcification. Pituitary - Adenoma Ovary - Fibrosis and Pigmentation.
(65)
Female Rat No. M15CF (Path No. 95635) Pituitary - Adenoma. Ovary - Cyst.
Female Rat No. B30CF (Path No. 95801) Kidney - Focal calcification.
Female Rat D29CF (Path No. 95803) Urinary Bladder (1) Chronic diffuse inflammation. (2) Diffuse mild hyperplasia.
The second phase of the review consisted of the microscopic examination of all tissues from the high dose females - a total of 36 animals. The inconsistencies are listed below:
Female Rat No. B14HF (Path. No. 95657) Eye was reported as not examined but eye was present and normal.
Female Rat No. F25HF (Path. No. 95823) Urinary Bladder - Mild diffuse hyperplasia.
Female Rat No. H7HF (Path No. 95623) Ovary - Neoplasm - probably granulosa cell tumor.
Female Rat No. H9HF (Path No. 95665) Heart - Focal fibrosis. Urinary Bladder - Mild focal hyperplasia.
Female Rat No. H15HF (Path No. 95665) Lymph Node - The diagnosis of lymphoma, benign, was present on the Searle microscopic report. According to Dr. Frith, lymphoma is generally not considered to be benign and he would diagnose lympphosarcoma.
Female Rat NO. H18HF (Path No. 95667) Pituitary - Adenoma. Brain - Mild bilateral hydrocephalus.
Female Rat No. K18HF (Path No. 95824) Pituitary - Adenoma
Female Rat No. K24HF (Path. No. 95671) Mass noted grossly - nothing consistent with mass reported microscopically.
(66)
Female Rat No. - M2HF (Path. No. 95672) Uterus - Chronic mild endometritis.
Female Rat No. M30HF (Path. No. 95343) Kidney - Focal calcification. Uterus - Chronic mild endometritis.
Female Rat No. M30HF (Path. No. 95675) Pancreas - Focal hyperplasia.
The third phase of this review consisted of microscopic verification of all masses reported grossly at necropsy from all female animals not examined in phases 1 and 2 and included a total of 73 animals. The inconsistencies are listed below:
Female Rat No. D10Lf (Path No. 92521) Subcutaneous mass was diagnosed as an angiofibroma on Searle report. The lesion is more consistent with an angiosarcoma.
Female Rat No. K9MF (Path. No. 95707) Uterus - Polyp.
Female Rat No. M1LF (Path. No. 95844) Tissue mass seen grossly was reported as missing and not available for microscopic examination. The tissue was present and was a mammary fibroadenoma.
In summary, Dr. Frith reviewed:
1) All 36 high dose females (all slides) including 3 that had been excluded from the study due to autolysis.
2) 36 (one-half) of the control females (all slides) including 1 animal that had been excluded from the study due to auto- lysis.
3) Remaining 73 female animals with grossly observed masses. (sufficient slides were reviewed to substantiate the masses)
4) 5 additional animals selected by the investigators (A1HM, A9HM, A29HM, C2CM, C24HM).
(67)
The slides reviewed in the first two categories above constituted 20% of the total animals on the study. Dr. Frith reviewed these slides blindly and then compared his findings with the Searle microscopic reports. According to Dr. Frith, his findings were in agreement with those of SEarle, for the most part. In his opinion, some of the lesions that he reported as inconsistencies were small, and might be considered insignificant by some pathologists. Dr. Frith did feel, however, that the ovarian neoplasms (animals H10CF, H19CF, and H7HP, and chronic cystitis and diffuse hyperplasia (animal D29CF) should have been reported..
Dr. Frith also considered two other discrepancies to be significant. They were:
1) The reporting of a mass (by Searle) as missing which was actually present (MlLF).
2) The finding of a polyp of the uterus which was not diagnosed by Searle (K9MF)
The second of the above two discrepancies assumes even more significance in view of the following:
The Histopathologic Summary table (table 11) in Volume I of the submission to FDA lists the following incidence of Uterine Polyps on page 87:
Incidence of Uterine Polyps
Controls Low Medium High 1 of 69 1 of 34 4 of 34 6 of 33 (1%) (3%) (12%) (18%)
The finding of one additional uterine polyp by Dr. Frith (in animal K9MF) increases the incidence in the mid dose to 5 of 34 (15%).
On page 82 of Volume I of the submission to FDA, is the statement: "other sporadic findings is included endometrial hyperplasia, polyp, cyst, congestion and squamous metaplasia." The term "sporadic findings" was used to characterize the incidence of uterine polyps, in spite of the fact that Searle had done a statistical analysis of these findings.
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April 25, 2012
French Language Version: ASPARTAME FACT SHEET - aka Canderel, NutraSweet, Equal, Neotame, Amino Sweet, etc. (en Francaise)
Dossier "Edulcorants de Synthèse"
L'amère vérité sur l'aspartame
Les substituts du sucre à base d'aspartame causent des symptômes inquiétants allant de la perte de mémoire jusqu'à des tumeurs au cerveau. Mais en dépit de l'approbation par la FDA (Food & Drug Administration - organisme de certification et de contrôle des aliments et médicaments aux États-Unis) le plaçant au tableau des additifs alimentaires "sans danger", l'aspartame est l'une des substances les plus dangereuses jamais imposées à un public sans méfiance.
Extrait du Nexus Magazine, Volume 2,
28 (Oct-Nov 95) et Volume 3
Aspartame/Neotame est le terme technique pour les marques portant le nom de NutraSweet, Canderel, Equal, AminoSweet, Spoonfuls, Susta et Equal-Measure. L'aspartame fut découvert accidentellement en 1965, lorsque James Schattler, un chimiste de G.D. Searle Company, était en train de tester un médicament antiulcère. L'aspartame fut autorisé pour les aliments secs en 1981 et pour les boissons gazeuses en 1983. Il fut au début approuvé pour les aliments secs le 26 juillet 1974, mais en raison d'objections émises par le Dr. John W. Olney, chercheur en science neurologique, et par l'Avocat général à la consommation, James Turner, Esq., en août 1974, et suite à des enquêtes sur les pratiques de recherche de G.D. Searle, la Food and Drug Administration (FDA) américaine a dû retarder son approbation de l'aspartame (5 décembre 1974). En 1985, Monsanto a acquis G.D. Searle et sépara Searle Pharmaceuticals et The NutraSweet Company en filiales distinctes.
L'aspartame est, de loin, la substance la plus dangereuse sur le marché à être ajoutée aux aliments. L'aspartame est tenu pour responsable de plus de 75% des réactions défavorables aux additifs alimentaires dont il a été fait rapport à la FDA. Bon nombre de ces réactions sont très sérieuses, y compris des attaques d'apoplexie et la mort ainsi qu'il en a été fait récemment état dans un rapport de février 1994 du Department of Health and Human Services. (1) Quelques-uns des 90 symptômes répertoriés et énumérés dans le rapport comme étant causés par l'aspartame incluent : Maux de tête/migraines, étourdissements, crises d'apoplexie, nausées, engourdissements, spasmes musculaires, gains de poids, irritations cutanées, dépression, fatigue, irritabilité, tachycardie, insomnie, problèmes visuels, perte d'ouie, palpitations cardiaques, difficultés respiratoires, crises d'anxiété, difficultés d'élocution, perte du goût, goût de fer, vertige, perte de mémoire et douleurs articulaires.
Selon les chercheurs et les médecins étudiant les effets indésirables de l'aspartame, les maladies chroniques suivantes peuvent être causée ou aggravées par l'ingestion d'aspartame: (2) tumeurs au cerveau, sclérose en plaques, épilepsie, syndrome de fatigue chronique, maladie de Parkinson, maladie d'Alzheimer, retard mental, lymphome, malformations congénitales, fibromalgie et diabètes.
L'aspartame est composé de trois produits chimiques : l'acide aspartique, la phénylalanine et le méthanol. Le livre "Prescription for Nutritional Healing" de James et Phyllis Balch, range l'aspartame dans la catégorie des "poisons chimiques". Comme vous allez le voir, c'est exactement ce qu'il est.
L'ACIDE ASPARTIQUE (40% DE L'ASPARTAME) Le Dr. Russell L. Blaylock, professeur en neurochirurgie à la Medical University of Mississippi, a récemment publié un ouvrage détaillant in extenso les dommages causés par l'ingestion excessive d'acide aspartique issu de l'aspartame. [Quatre vingt dix neuf pour cent du glutamate de monosodium 9MSG est de l'acide glutamique. Les dommages qu'il cause sont également documentés dans le livre de Blaylock.] Blaylock fait mention de près de 500 références scientifiques afin de démontrer comment un excès d'acides aminés libres excitateurs tels que l'acide aspartique et l'acide glutamique dans notre alimentation sont cause de sérieux désordres neurologiques chroniques et d'une myriade d'autres symptômes aigus. (3)
RÉSUMÉ DE LA FAÇON DONT L'ASPARTAME/NEOTAME CAUSE DES DOMMAGES L'aspartame et le glutamate agissent comme neurotransmetteurs dans le cerveau en facilitant la transmission de l'information entre les neurones. Trop d'aspartame ou de glutamate dans le cerveau détruit certains neurones en autorisant l'invasion excessive de calcium dans les cellules. Cette invasion déclenche des taux excessifs de radicaux libres qui tuent les cellules. La perte en cellules nerveuses qui peut être causée par le glutamate et l'aspartame en excès est la raison pour laquelle on les appelle "excitotoxines". Ils "excitent" ou stimulent la mort des cellules nerveuses.
L'acide aspartique est un acide aminé. Pris sous sa forme libre (non relié aux protéines), il élève d'une façon significative le niveau de plasma sanguin en aspartame et glutamate. L'excès d'aspartame et de glutamate dans le plasma sanguin, peu après l'ingestion d'aspartame ou de produits contenant de l'acide glutamique libre (précurseurs du glutamate), provoque une élévation du niveau de ces neurotransmetteurs dans certaines zones du cerveau.
La barrière sanguine du cerveau (Blood Brain Barrier [BBB]) qui normalement protège le cerveau d'un excès de glutamate ou d'aspartame, aussi bien que de toxines, 1) n'est pas complètement développée pendant l'enfance, 2) ne protège pas complètement toutes les régions du cerveau, 3) est endommagée par un nombre de conditions chroniques et aiguës et 4) permet l'infiltration d'un excès de glutamate et d'aspartame dans le cerveau, même lorsqu'elle est intacte.
L'excès de glutamate et d'aspartame commence lentement à détruire les neurones. La grande majorité (75%+) des cellules nerveuses d'une zone particulière du cerveau sont tuées avant même que les symptômes cliniques d'une maladie chronique ne soient décelés. Quelques unes des nombreuses maladies chroniques dont il a été démontré qu'elles sont causées par une exposition à long terme au dommage des excitotoxines comprennent : la sclérose en plaques, ALS, perte de mémoire, problème hormonaux, perte d'audition, crises d'épilepsie, maladie d'Alzheimer, maladie de Parkinson, hypoglycémie, démence du Sida, lésions du cerveau et désordres neuroendocrinaux.
Les risques encourus par les nourrissons, enfants, femmes enceintes, personnes âgées et les personnes avec des problèmes de santé chroniques causés par les excitotoxines sont grands. Même la Federation of American Societies For Experimental Biology (FASEB), qui minimise habituellement les problèmes et se conforme à la ligne de conduite de la FDA, a déclaré récemment "qu'il était prudent d'éviter l'utilisation de suppléments diététiques d'acide L-glutamique chez les femmes enceintes, les nourrissons et les enfants. L'existence d'une évidence d'effets secondaires potentiels endocrinaux, tels qu'une prolactine et une cortisolie élevée et des réponses différentielles entre hommes et femmes, suggéreraient également un lien neuroendocrinal et qu'un supplément d'acide L-glutamique devrait être évité par les femmes en âge de procréer et les individus atteints de désordres affectifs." (4) L'acide aspartique de l'aspartame possède les même effets délétères sur le corps que l'acide glutamique.
Le mécanisme exact des réactions aiguës à l'excès du glutamate et de l'aspartame libre est actuellement débattu. Ainsi qu'il en est fait état par la FDA, ces réactions incluent: (5) Maux de tête/migraines, nausées, douleurs abdominales, fatigue (bloque l'entrée suffisante de glucose dans le cerveau), problèmes du sommeil, problème de vision, attaque d'anxiété, dépression et asthme/oppression respiratoire.
Une des plaintes commune chez les personnes souffrant des effets de l'aspartame est la perte de mémoire. Ironiquement, en 1987, G.D.Searle, le fabricant de l'aspartame, entreprit une recherche sur un médicament pouvant combattre les pertes de mémoire causées par les dommages dus aux acides aminés excitotoxiques. Blaylock est l'un des nombreux scientifiques et médecins intéressés par les dommages causés par les excitotoxines dus à l'ingestion d'aspartame et de MSG. Quelques-uns des nombreux experts qui se sont manifestés contre les dommages causés par l'aspartame et le glutamate incluent Adrienne Samuels, Ph.D., psychologue expérimental, spécialisée en recherche conceptuelle. De même, Olney, professeur dans le département de psychiatrie, School of Medecine, Washington University, neuroscientifique et chercheur et l'une des autorités les plus représentatives en matière d'excitotoxines. (Il informa Searle en 1971 que l'acide aspartique causait des trous dans le cerveau des souris). Également, Francis J. Waickman, Docteur en médecine, à qui a été attribué le Rinkel and Forman Awards et diplômé par le Conseil en pédiatrie, allergies et immunologie.
D'autres scientifiques concernés sont : John R. Hain, Docteur en médecine, Diplômé par le Conseil en pathologie de médecine légale et H.J. Roberts, M.D., FACP, FCCP, spécialiste du diabète et sélectionné par une publication médicale nationale comme "Le meilleur docteur aux États-Unis".
De même, John Samuels est concerné. Il compila une liste de recherches scientifiques suffisante pour montrer les dangers de l'ingestion excessive d'acide aspartique et glutamique libre. Et il y en a d'autres encore, nombreux, qui peuvent être ajoutés à cette longue liste.
PHÉNYLALANINE (50% DE L'ASPARTAME) La phénylalanine est un acide aminé qui est normalement présent dans le cerveau. Les personnes souffrant du désordre génétique, phenylketonuria (PKU), ne peuvent pas métaboliser la phénylalanine. Ceci conduit à des hauts niveaux dangereux de phénylalanine dans le cerveau (parfois mortels). Il a été démontré que l'ingestion d'aspartame, particulièrement avec des hydrates de carbones, peut provoquer des niveaux excessifs de phénylalanine dans le cerveau, même chez des personnes ne souffrant pas de PKU. Ceci n'est pas une simple théorie, car de nombreuses personnes ayant mangé de grandes quantités d'aspartame au cours d'une longue période de temps et ne souffrant pas de PKU, ont été reconnues possédant des niveaux excessifs de phénylalanine dans le sang. Des niveaux excessifs de phénylalanine dans le cerveau peuvent amener une décroissance du niveau de sérotonine dans le cerveau, conduisant à des désordres émotionnels comme la dépression. Il a été démontré au cours de tests sur l'homme que les niveaux de phénylalanine dans le sang étaient accrus d'une façon significative chez les sujets humains ayant utilisé chroniquement l'aspartame. (6) Même une seule prise d'aspartame fait monter les niveaux de phénylalanine. Dans son témoignage devant le Congrès américain, le Dr. Louis J. Elsas démontra qu'une haute teneur en phénylalanine dans le sang peut se concentrer dans des parties du cerveau et est particulièrement dangereuse pour les nourrissons et les foetus. Il a également démontré que la phénylalanine est métabolisée bien plus efficacement par les rongeurs que par les humains. (7)
La prise en compte d'un cas de niveaux de phénylalanine extrêmement élevés provoqués par l'aspartame a été publiée récemment par le "Wednesday Journal" dans un article intitulé "An aspartame Nightmare" (un cauchemar à l'aspartame). John Cook commença par boire 6 à 8 boissons light par jour. Ces symptômes débutèrent par des pertes de mémoire et de fréquents maux de tête. Il continua par développer un besoin accru de boissons édulcorées à l'aspartame. Sa condition physique se détériora tellement qu'il connu des changements d'humeur importants et de violentes colères. Alors même qu'il ne souffrait pas de PKU, un examen sanguin révéla un niveau de phénylalanine de 80 mg/dl. Il dévoila également une fonction cérébrale anormale et une détérioration du cerveau. Après avoir interrompu sa consommation d'aspartame, ses symptômes se sont améliorés radicalement.(8)
Ainsi que Blaylock le souligne dans son ouvrage, les premières études mesurant l'accumulation de phénylalanine dans le cerveau étaient défectueuses. Les chercheurs qui la mesurèrent dans des régions spécifiques du cerveau et non la moyenne dans tout le cerveau notèrent des hausses significatives des niveaux de phénylalanine. Spécifiquement, les régions de l'hypothalamus, medulla oblongata et corpus striatum du cerveau avaient l'augmentation la plus importante en phénylalanine. Blaylock poursuit en soulignant que l'augmentation excessive de phénylalanine dans le cerveau peut causer de la schizophrénie ou rendre les personnes susceptibles de souffrir d'une attaque d'apoplexie.
Ainsi, une utilisation excessive, à long terme, de l'aspartame peut mener à une accélération des ventes des inhibiteurs à la sératonine tel que le Prozac et des médicaments pour contrôler la schizophrénie et les attaques.
MÉTHANOL (ALCOOL DE BOIS D'AKA/POISON) (10% DE L'ASPARTAME) Le Méthanol/alcool de bois est un poison mortel. Certaines personnes peuvent se rappeler du méthanol comme étant le poison qui a été à l'origine de la perte de la vue, ou de la mort, de certains alcooliques "risque-tout". Le méthanol est graduellement libéré dans l'intestin grêle lorsque l'aspartame du groupe méthyle rencontre l'enzyme chymotryspine.
L'absorption du méthanol par l'organisme est accélérée considérablement lorsque du méthanol libre est ingéré. Le méthanol libre est créé à partir de l'aspartame lorsqu'il est chauffé au-dessus de 30° centigrade. Ceci s'opère lorsque le produit contenant de l'aspartame est incorrectement stocké ou lorsqu'il est chauffé (par exemple, comme composant d'un produit "alimentaire" tel que le Jello). Le méthanol se décompose dans le corps en acide formique et en formaldehyde. Le formaldehyde est une neurotoxine mortelle. Une évaluation du méthanol établie par l'EPA déclare que le méthanol "est considéré comme poison cumulatif compte tenu de la faible proportion qui en est éliminée une fois qu'il est absorbé. Dans l'organisme, le méthanol s'oxyde en formaldehyde et en acide formique; chacun de ces deux métabolites sont toxiques." Il est recommandé une limite de consommation de 7.8 mg/jour. Un litre de boisson édulcorée à l'aspartame contient environ 56 mg de méthanol. Les gros utilisateurs de produits contenant de l'aspartame consomment jusqu'à 250 mg de méthanol quotidiennement ou 32 fois la limite fixée par l'EPA. (9)
Les symptômes d'un empoisonnement au méthanol sont des maux de tête, bourdonnement d'oreilles, dérangements gastro-intestinaux, faiblesse, vertige, frissons, trous de mémoire, engourdissement et douleurs fulgurantes des extrémités, troubles du comportement et névrite. Les problèmes les plus connus d'un empoisonnement au méthanol sont les problèmes de la vue comprenant vision embrumée, rétrécissement progressif du champ visuel, vision voilée, vision obscurcie, dommages rétiniens et perte de la vue. Le formaldehyde est un cancérigène connu, il cause des dommages à la rétine, s'oppose à la reproduction de l'ADN et cause des malformations congénitales. (10)
Étant donné l'absence de certains enzymes clefs, les humains sont beaucoup plus sensibles aux effets toxiques du méthanol que les animaux. Par conséquent, des tests d'aspartame ou de méthanol sur des animaux ne reflètent pas précisément les dangers encourus par les humains. Ainsi que le souligne le Dr. Woodrow C. Monte, Directeur du Food Science and Nutrition Laboratory à l'Université de l'État de l'Arizona, « Il n'existe aucune étude sur les humains ou les mammifères pour évaluer les effets mutagène, tératogène ou cancérigène possibles conséquentes à l'administration chronique de l'alcool de méthyle. » (11)
Il se sentit tellement concerné en voyant les conclusions sur la sécurité demeurer sans solutions qu'il adressa une requête à la FDA réclamant une audition afin de discuter de ces résultats. Il demanda à la FDA de « ralentir la publication des conclusions concernant les boissons sucrées assez longtemps afin qu'il soit possible de répondre à quelques-unes des questions essentielles. Il n'est pas juste que vous laissiez tout le poids de l'authentification sur le petit nombre que nous représentons alors que nous possédons des ressources tellement limitées. Vous ne devez pas oublier que vous êtes l'ultime défense du public américain. Une fois que vous en aurez autorisé l'usage (de l'aspartame), il n'y aura littéralement plus rien que moi ou mes collègues ne pourrons faire pour inverser le processus. L'aspartame rejoindra alors la saccharine, les agents sulfites et Dieu sait encore combien d'autres composants contestables prescrits pour insulter la constitution humaine avec l'approbation du gouvernement. » (10) Peu de temps après, le commissaire à la FDA, Arthur Hull Hayes, Jr. approuva l'utilisation de l'aspartame dans les boissons gazeuses, puis il fut engagé par une société de relations publiques de la G.D. Searle. (11)
Il a été souligné que certains des jus de fruits et des boissons alcoolisées contiennent de petites quantités de méthanol. Il est important de se rappeler, cependant, que le méthanol n'apparaît jamais seul. Dans tous les cas, l'éthanol est présent, usuellement en plus grandes quantités. L'éthanol est un antidote à la toxicité du méthanol chez l'homme. (9) Les hommes des troupes de l'opération "Desert Storm" (guerre du Golfe) furent "régalées" avec de grandes quantités de boissons édulcorées à l'aspartame qui avaient été chauffées à plus de 30° centigrades par le soleil de l'Arabie Saoudite. Beaucoup d'entre eux en revinrent avec de nombreux désordres similaires à ceux trouvés chez des individus qui avaient été chimiquement empoisonnés par le formaldehyde. Le méthanol libre dans ces breuvages peut avoir été un facteur contribuant à ces maladies. D'autres produits dérivés de l'aspartame tel que le DKP (voir ci-dessus) peut également avoir été un facteur. En 1993, dans un acte qui peut être décrit comme "inconscient", le FDA approuva l'aspartame comme ingrédient dans un certain nombre d'articles d'alimentaires qui seraient toujours chauffés au-dessus de 30° centigrades.
DIKETOPIPERAZINE (DKP) La DKP est un produit dérivé de la métabolisation de l'aspartame. La DKP a été impliquée dans l'apparition de tumeurs au cerveau. Olney a remarqué que la DKP, lorsqu'elle était nitroazotée dans l'intestin, produisait un composant qui était similaire au N-nitrosourea, un composant chimique puissant causant des tumeurs au cerveau. Certains auteurs ont dit que la DKP est produite après ingestion de l'aspartame. Je ne suis pas sûr que ce soit correct. Il est définitivement vrai que la DKP est formée dans des produits liquides contenant de l'aspartame au cours d'un stockage prolongé.
G.D. Searle a conduit une expérimentation sur des animaux pour vérifier la sûreté de la DKP. La FDA releva un certain nombre d'erreurs, y compris « des erreurs d'écriture, d'animaux mélangés, d'animaux à qui on n'administrait pas la drogue qu'ils étaient supposés prendre, de perte de spécimens pathologiques due à une mauvaise manipulation » et de nombreuses autres erreurs. (12) Ces procédures de laboratoires négligentes peuvent expliquer pourquoi les animaux servant aux tests et ceux servant de groupe contrôle avaient seize fois plus de tumeurs au cerveau que le nombre auquel on pourrait s'attendre au cours d'expérimentations de cette durée.
Par un tour du sort, très peu de temps après la découverte de ces erreurs d'expérimentation, la FDA utilisa des protocoles recommandés par G.D. Searle pour développer les standards industriels de la FDA pour les pratiques des laboratoires alimentaires. (11) La DKP a également été impliquée comme ayant causé des polypes utérins et des modifications du taux de cholestérol par le Dr. Jacqueline Verrett, toxicologue de la FDA, dans sa déposition devant le Sénat des États-Unis. (13)
ALIMENTS RÉSULTANT DE L'ASPARTAME
Les composants de l'aspartame peuvent entraîner l'apparition d'une foule de maladies diverses. Quelques-unes apparaissent graduellement, d'autres sont immédiates, avec des réactions aiguës.
Il y a une énorme population d'individus qui souffrent de symptômes attribués à l'aspartame et cependant ils ne comprennent pas pourquoi les plantes ou les médicaments ne parviennent pas à les soulager de leurs problèmes. Il y a d'autres utilisateurs d'aspartame qui paraissent ne pas souffrir de réactions immédiates à l'aspartame. Mais même ces individus sont susceptibles à long terme de souffrir des dommages causés par les acides aminés excitateurs, la phénylalanine, le méthanol et la DKP. Quelques-uns des nombreux désordres qui m'inquiètent particulièrement incluent les suivants.
malformations congénitales
Le Dr. Diana Dow Edwards, un chercheur, fut commanditée par Monsanto afin d'étudier les possibilités de malformations congénitales causées par l'ingestion d'aspartame. Après qu'une information préliminaire ait fait état d'informations négatives au sujet de l'aspartame, les fonds alloués à la recherche furent retirés. Un pédiatre génétique à Emory University a attesté que l'aspartame causait des malformations congénitales. 7360-367
Dans le livre "While Waiting" (En attendant) : un guide prénatal de George R. Verrilli, M.D. et Anne Marie Mueser, il est fait état que l'aspartame est soupçonné de causer des dommages au cerveau des individus sensibles. Ces effets peuvent faire courir un risque à un foetus. Des chercheurs ont suggéré que de grandes doses d'aspartame peuvent être associées à des problèmes allant d'étourdissements et de modifications subtiles du cerveau à des retards mentaux.
Cancer (Cancer du cerveau) En 1981, Satya Dubey, un statisticien du FDA, déclara que l'information concernant l'aspartame et les tumeurs au cerveau était si "préoccupante" qu'il pourrait ne pas recommander l'autorisation du NutraSweet. (14) Au cours d'une étude menée sur une période de deux ans et conduite par le fabricant de l'aspartame, douze des 320 rats nourris normalement et à l'aspartame développèrent des tumeurs au cerveau alors qu'aucun des rats de contrôle n'eurent de tumeurs. Cinq des douze tumeurs furent trouvées sur des rats nourris avec de faibles doses d'aspartame. (15) L'autorisation de l'aspartame fut une violation de l'amendement Delaney (aux États-Unis) qui était censé prémunir contre l'introduction dans notre alimentation de substances cancérigènes tel que le méthanol (Formaldehyde) et la DKP. Feu le Dr. Adrian Gross, un toxicologue de la FDA, affirma dans son témoignage devant le Congrès américain que l'aspartame était capable de provoquer des tumeurs au cerveau. Il devint illégal pour la FDA d'en permettre une prise quotidienne, quelqu'en soit la dose. Il établit dans sa déposition que les études de la compagnie Searle étaient « dans une large mesure, sujettes à caution » et que « au moins, une de ces études avait établi au-delà de tout doute raisonnable que l'aspartame est capable d'induire des tumeurs au cerveau des animaux d'expérience... » Il conclut sa déposition en demandant, « Quelle peut être la raison de l'apparent refus de la FDA d'invoquer pour cet additif alimentaire le bien-nommé amendement Delaney sur la loi concernant l'alimentation, les médicaments et les cosmétiques?... Et si la FDA elle-même décide de violer la loi, que reste-t-il pour protéger la santé du public? » (16)
Au cours des années 70, on découvrit que le fabricant de l'aspartame avait falsifié des études de plusieurs façons. Une des techniques utilisées était de supprimer les tumeurs apparues sur les animaux soumis aux tests et de les remettre en circulation dans le groupe d'étude. Une autre technique employée pour falsifier ces études étaient de faire figurer sur les listes, des animaux morts comme ayant survécu aux tests. Ainsi, l'information concernant les tumeurs du cerveau était encore pire qu'on aurait pu le croire précédemment. De plus, un ancien employé du fabricant de l'aspartame, Raymond Schroeder, informa la DPA le 13 juillet 1977 que les particules de DKP étaient en si grandes quantités que les rats pouvaient faire la différence entre le DKP et leur alimentation normale. (12)
Il est intéressant de noter que l'indice des tumeurs au cerveau chez les personnes de plus de 65 ans s'est accrue de 67% entre les années 1973 et 1990. Les tumeurs au cerveau dans les groupes de tous âges se sont accrues de 10%. La croissance la plus importante s'opéra au cours des années 1985-1987. (17)
Le diabète
L'American Diabetes Association (ADA) va même jusqu'à recommander ce poison chimique à des personnes souffrant du diabète. Selon la recherche menée par H.J. Roberts, diabétologue, membre de l'ADA et faisant autorité dans l'étude des édulcorants artificiels, l'aspartame : 1) conduit à une accélération des diabètes cliniques. 2) est la cause d'une difficulté de contrôle du diabète chez les diabétiques insulino-dépendants ou traités par voie orale. 3) conduit à l'aggravation des complications du diabète telle que la rétinopathie, les cataractes, la neuropathie et la gastroparésie. 4) cause des convulsions.
Dans une déclaration concernant l'utilisation des produits contenant de l'aspartame par des personnes souffrant de diabète et d'hypoglycémie, Robert dit : « Malheureusement, bon nombre de mes patients habituels et d'autres vus en consultation, développent de sérieuses complications métaboliques, neurologiques et autres qui pourraient être spécifiquement attribuées à l'usage des produits contenant de l'aspartame. Ceci fut mis en évidence par : la perte du contrôle du diabète, l'intensification de l'hypoglycémie, l'apparition de soi-disant "réactions à l'insuline" (y compris des convulsions) qui en fait furent reconnues comme des réactions à l'aspartame et la précipitation, l'aggravation ou la simulation de complications diabétiques (spécialement une diminution de la vue et de la neuropathie) pendant l'utilisation de ces produits. Une amélioration frappante de ces symptômes se révéla après l'éviction de l'aspartame et la prompte et prévisible récurrence de ces problèmes lorsque le patient reprenait des produits à l'aspartame, consciemment ou par inadvertance. » Roberts poursuit ainsi : « Je regrette l'omission des autres médecins et de l'American Diabetes Association (ADA) d'émettre les avertissements appropriés aux patients et aux utilisateurs basés sur ces découvertes répétées qui ont été décrites dans mes études exemptes de toute influence corporative et dans mes publications. »
Baylock déclara que des excitotoxines telles que celles trouvées dans l'aspartame peuvent accélérer le diabète chez des sujets qui sont génétiquement susceptibles de souffrir de cette maladie. (5)
Désordres émotionnels
Une étude "en double aveugle" sur les effets de l'aspartame sur des sujets souffrant de désordres émotionnels fut récemment menée par le Dr. Ralph G. Walton. Étant donné que l'étude ne fut pas commanditée/contrôlée par les fabricants d'aspartame, la compagnie NutraSweet refusa de lui vendre de l'aspartame. Walton fut obligé de s'en procurer et de le faire certifier par une source extérieure. L'étude démontra une croissance importante de graves symptômes chez les personnes prenant de l'aspartame. Certains de ces symptômes étaient si graves que l'Institutional Review Bord se trouva dans l'obligation d'arrêter l'étude. Trois des participants avaient dit qu'ils avaient été "empoisonnés" par l'aspartame. Walton conclut que « des individus sujets à des désordres émotionnels sont particulièrement sensibles à cet édulcorant artificiel; son utilisation par cette population devrait être découragée. » (18) Conscient que l'expérimentation ne pourrait pas être répétée compte tenu du danger encouru par les sujets soumis aux tests, Walton fut cité récemment comme disant : « Je sais que cela provoque des crises d'apoplexie. Je suis convaincu également que cela provoque avec certitude des modifications comportementales. Je suis très en colère de voir cette substance sur le marché. Je mets personnellement en cause la validité et la véracité de n'importe laquelle des études commanditées par NutraSweet Company. » (19)
Il est fait état de nombreux cas de faibles niveaux de sérotonine cervicale, de dépressions et autres désordres émotionnels qui ont été reliés à l'aspartame et qui sont souvent soulagés en arrêtant la consommation d'aspartame. Des chercheurs ont souligné que l'augmentation des niveaux de phénylalanine dans le cerveau, qui peut arriver et arrive chez des sujets ne souffrant pas de PKU, provoque une baisse du niveau de ce neuro-transmetteur (sérotonine) qui mène à une foule de désordres émotionnels différents. Le Dr. William M. Pardrige de l'UCLA déclara dans son témoignage devant le Sénat américain qu'un adolescent buvant quatre bouteilles de 16 onces (487 grs) de boisson gazeuse (soda) Diète (sans sucre) par jour subit une énorme hausse du niveau de phénylalanine.
Épilepsie/Apoplexie
Avec le nombre important et croissant d'apoplexies causées par l'aspartame, il est triste de constater que l'Epilepsy Foundation fait la promotion de la "sécurité" de l'aspartame. Au Massachusetts Institute of Technology (MIT), 80 personnes qui avaient souffert de crises d'apoplexie après ingestion d'aspartame avaient été mises en observation. Le Community Nutrition Institute apporta les conclusions suivantes de cette observation : « Ces 80 cas correspondent à la définition même de la FDA d'un risque imminent encouru pour la santé publique et qui entraîne normalement le retrait expéditif d'un produit par la FDA. »
Le magazine de l'Air Force "Flying Safety" et celui de la Navy "Navy Physiology" ont publié des articles mettant en garde contre les nombreux dangers de l'aspartame incluant les effets nocifs cumulatifs du méthanol et les plus grandes possibilités de malformations congénitales. Les articles notaient que l'ingestion de l'aspartame pouvaient rendre les pilotes plus susceptibles à des crises d'apoplexie et de vertige. Vingt articles émettant des avertissements au sujet de l'ingestion d'aspartame pendant un vol ont pu être lus dans le National Business Aircraft Association Digest (NBAA Digest 1993), Aviation Medical Bulletin (1988), The Aviation Consumer (1988), Canadian General Aviation News (1990), Pacific Flyer (1988), General Aviation News (1989), Aviation Safety Digest (1989) et Plane & Pilot (1990) et un article avertissant des dangers de l'aspartame fut présenté au 57ème Congrès Annuel de l'Aerospace Medical Association (Gaffney 1986). (Mary Nash Stoddard's - Aspartame Consumer Safety Network & Pilot Hotline since 1987)
Récemment, une ligne ouverte accessible 24 heures sur 24 fut mise en place pour répondre aux pilotes souffrant de réactions aiguës à l'ingestion d'aspartame. Plus de 600 pilotes ont déclaré avoir eu des symptômes incluant ceux qui mentionnés dans le rapport à propos de crises d'épilepsie dans leur cockpit dues à l'aspartame. (21)
Une des premières études sur l'aspartame fut réalisée en 1969 par un scientifique indépendant, le Dr. Harry Waisman. Il étudia les effets de l'aspartame sur des bébés primates. Sur les sept bébés singes, l'un mourut au bout de 300 jours et cinq autres eurent des crises d'épilepsie. Bien entendu, ces découvertes négatives ne furent pas soumises à la FDA au cours de la procédure d'approbation. (22)
Pourquoi n'entendons-nous pas parler de ces choses-là? La raison pour laquelle les gens n'entendent pas parler des sérieuses réactions à l'aspartame est double : 1) Manque d'information de la population générale. Il n'est pas fait mention dans les journaux des maladies causées par l'aspartame comme le sont les accidents d'avion. Ceci parce que ces incidents arrivent isolément dans des milliers d'endroits différents des États-Unis (et du monde). 2) La plupart des gens n'associent pas leurs symptômes à un emploi à long terme de l'aspartame. Pour les gens qui ont ainsi détruit un pourcentage important des cellules de leur cerveau et ainsi causé une maladie chronique, il leur est impossible de pouvoir associer cette maladie à la consommation d'aspartame. La façon dont l'aspartame a été approuvé est une leçon démontrant comment les industries chimiques et pharmaceutiques peuvent manipuler les organismes gouvernementaux telle la FDA, les organisations "corrompues" telle l'American Dietetic Association et l'ensemble de la communauté scientifique avec des études mal réalisées et frauduleuses soutenues par les industriels et financées par les fabricants d'aspartame.
Erik Millstone, un chercheur au Science Policy Research de l'Université du Sussex a compilé des milliers de pages de preuves, certaines ayant été obtenues par l'usage de la loi 23 sur la liberté de l'information, démontrant que : 1. des tests en laboratoires étaient falsifiés et les dangers dissimulés; 2. des tumeurs furent enlevés d'animaux et des animaux qui étaient morts furent "ressuscités" dans les rapports de laboratoire; 3. des déclarations fausses et trompeuses ont été faites à la FDA; 4. les deux juges d'instruction fédéraux missionnés pour réunir des charges de fraudes contre le fabricant d'aspartame furent engagés par le cabinet d'avocat du fabricant, laissant dépasser le terme du délai légal de prescription; 5. le Commissaire de la FDA ne tint pas compte des objections émises par le propre bureau d'études de la FDA. Peu de temps après cette décision, ce commissaire accepta un poste chez Burson-Marsteller, la société chargée des relations publiques de G.D. Searle.
Une commission d'enquête publique (Public Board of Inquiry, PBOI) fut mise en place en 1980. Elle comprenait trois scientifiques qui étudièrent les objections d'Olney et Turner contre l'autorisation de l'aspartame. Ils votèrent unanimement contre l'approbation de l'aspartame. Le Commissaire de la FDA, le Dr. Arthur Hull Hayes, Jr. nomma alors une commission scientifique de 5 personnes pour étudier les découvertes de la PBOI. Après qu'il fut clair que la commission confirmerait la décision de la PBOI par un vote de 3 contre 2, une autre personne fut adjointe à la commission, créant de ce fait une impasse par un vote de 3 contre 3. Ceci permit au Commissaire de la FDA de briser l'impasse et d'approuver l'aspartame pour les aliments secs en 1981. Le Dr. Jacqueline Verrett, doyenne scientifique d'une commission d'étude d'un Bureau of Foods de la FDA mise en place en août 1977 afin d'étudier le rapport Bressler (un rapport qui décrivait les procédures douteuses de la compagnie G.D. Searle au cours des tests probatoires) explique : « Il était particulièrement évident que quelque part le long de la chaîne, les officiels du bureau travaillaient à une exonération. » En 1987, le Dr. Verrett dans une déposition devant le Sénat Américain, déclara que les expérimentations menées par Searle étaient "désastreuses". Elle déclara que son équipe fut instruite de ne pas émettre de commentaires sur la validité des études ni de s'en préoccuper. Elle déclara qu'il n'avait pas été apporté réponse à des questions concernant les malformations congénitales. Elle poursuivit sa déposition en exposant le fait qu'il avait été démontré que la DKP accroissait la formation de polypes utérins et augmentait le taux de cholestérol dans le sang et que l'augmentation de la température du produit mène à un accroissement de la production de la DKP. (13)
Les "portes tournantes"
La FDA et les fabricants d'aspartame eurent un mouvement de personnel important pendant de nombreuses années. A part le Commissaire de la FDA et les deux juges d'instruction fédéraux démissionnant pour être engagés par des sociétés en relation avec G.D. Searle, quatre autres officiels de la FDA en relation avec l'approbation de l'aspartame acceptèrent des emplois en relation avec l'industrie du NutraSweet entre 1979 et 1982, y compris le Commissaire Délégué de la FDA, l'Assistant Spécial au Commissaire de la FDA, le Directeur adjoint du Bureau of Foods and Toxicology et le Procureur impliqué dans le Bureau d'Enquête Publique (Public Board of Inquiry). (24)
Il est important de réaliser que ce phénomène dit des "portes tournantes" s'est répété durant des décennies. La Townsend Letter for Doctors (11/92) rend compte d'une étude révélant que 37 des 49 responsables les plus importants de la FDA ont accepté des postes dans des compagnies au sujet desquelles ils avaient rendu des décisions durant leur mandat à la FDA. Elle fit également état du fait que plus de 150 fonctionnaires hauts placés de la FDA possédaient des actions de compagnies qu'ils avaient la responsabilité de surveiller. De nombreuses organisations et universités reçurent des sommes très importantes de compagnies reliées à la NutraSweet Association, un groupe de compagnies promouvant l'utilisation de l'aspartame. En janvier 1993, l'American Dietetic Association reçu un don de 75 000 US$ de la NutraSweet Company. L'American Dietetic Association a déclaré que la NutraSweet Company rédigeait ses pages intitulées "Des Faits". (25)
Plusieurs autres organisations et chercheurs soi-disant "indépendants" reçoivent des sommes importantes des fabricants d'aspartame. L'American Diabetes Association a reçu un montant très important de NutraSweet, dont notamment une somme pour le fonctionnement d'une école culinaire à Chicago (vraisemblablement pour enseigner aux diabétiques comment utiliser NutraSweet dans leur cuisine).
Un chercheur d'un état de la Nouvelle-Angleterre qui avait souligné par le passé les dangers de l'aspartame est maintenant un consultant à l'emploi de Monsanto. Un autre chercheur du sud-est des États-Unis avait témoigné des dangers de l'aspartame pour les foetus. Un journaliste d'enquête a révélé qu'on lui a demandé de « la fermer » afin d'éviter la perte d'un don important en provenance d'un fabricant de cola diététique appartenant à la NutraSweet Association.
Que fait la FDA pour protéger le consommateur des dangers de l'aspartame?
Moins que rien.
En 1992, la FDA autorisa l'utilisation de l'aspartame dans les boissons maltées, les céréales pour petit déjeuner et les garnitures et gâteaux glacés. En 1993, la FDA autorisa l'utilisation de l'aspartame dans les bonbons durs et mous, les boissons non-alcoolisées en vogue, les boissons au thé, les jus de fruits et les concentrés, les viennoiseries et les préparations à pâtisserie, les gelées, les crèmes et nappages pour les pâtisseries.
En 1991, la FDA a interdit l'importation du stevia. La poudre de cette feuille a été utilisée pendant des centaines d'années comme édulcorant. Elle est largement utilisée au Japon sans aucun effet contraire. Des scientifiques engagés pour étudier le stevia l'ont déclaré propre à la consommation humaine, ce qui a été tout à fait reconnu dans de nombreuses régions du monde où il n'est pas interdit. Toutes les personnes à qui j'ai parlé de cette question croient que le stevia a été interdit afin qu'il ne puisse s'implanter aux USA et réduire ainsi les ventes de l'aspartame. (26)
Que fait le Congrès américain pour protéger le consommateur des dangers de l'aspartame? Rien.
Que fait l'Administration américaine (Président) pour protéger le consommateur des dangers de l'aspartame? Rien.
La consommation d'aspartame n'est pas seulement un problème aux USA. Il est en vente dans plus de 70 pays dans le monde.
L'ASPARTAME PEUT ÊTRE TROUVÉ DANS : - les petits-déjeuners instantanés - les rafraîchisseurs d'haleine (rice-bouche) - les céréales - les gommes à mâcher sans sucre - les mélanges au cacao - les boissons au café - les desserts réfrigérés - les desserts gélatineux - les boissons à base de jus de fruits - les laxatifs - les multivitamines pour adulter et pour enfants - les boissons au lait - les médicaments et suppléments nutritifs - les mélanges mixés - les boissons non alcoolisées - les édulcorants de table - les boissons au thé - les thés et cafés instantanés - les mousses et crèmes décoratives - les glaçages - les yaourts (yogourts)
Il m'a été dit que de l'aspartame a été trouvé dans des produits alors qu'il n'était pas mentionné sur la liste des ingrédients figurant sur l'emballage. On doit faire particulièrement attention aux produits pharmaceutiques et aux suppléments nutritionnels. J'ai été informé que même quelques suppléments fabriqués par des fabricants connus tel que Twinlabs contiennent de l'aspartame.
L'information présentée ici n'est que la pointe de l'iceberg car il y a énormément d'information négative au sujet l'aspartame. Afin que le lecteur puisse obtenir de plus amples informations, j'ai inclus quelques sources ci-après.
OUVRAGES *Blaylock, Russell L., Excitotoxins : The Taste That Kills (Health Press, Santa Fe, New Mexico, |1994). Un des meilleurs ouvrages disponibles sur les excitotoxines. Vaut le coup d'être lu ! *Mary Nash Stoddard, Deadly Deception Story of Aspartame, disponible par le réseau de l'aspartame Consumer Safety. *Aspartame Consumer Safety Network, (Aspartame Consumer Safety Network synopsis.) ASPARTAME CONSUMER SAFETY NETWORK and Pilot Hotline (since 1987) - P.O. Box 2001, Frisco Texas 75034, USA Tél.: (214) 387-4001 ; email: marystod@airmail.net
Pour obtenir plus de renseignements (disponible en anglais seulement), mettez juste dans la ligne "sujet" de votre courriel : la fondatrice de Aspartame Consumer Safety Network and Pilot Hotline, Hon. Mary Nash Stoddard.
Mais surtout visitez:<http://aspartamesafety.com/> <http://marystod.blogspot.com/><http://www. youtube.com /watch?v=RQoOajjC8GE> http://www.youtube.com/watch?v=LgBiw_Il5YMhttp://www.youtube.com/watch?v=2mVA03IzsFM&feature=relatedhttp://www.youtube.com/watch?v=I-vO8aY-I4Y&feature=relatedhttp://www.youtube.com/watch?v=cSx2E9iz36w&feature=relatedhttp://twitter.com/marystodhttp://search.yahoo.com/search?ei=utf-8&fr=aaplw&p=%22Mary+Nash+Stoddard%22
April 20, 2012
Drug Company Committed Illegal Acts to Get Aspartame Appr...
Drug Company Committed Illegal Acts to Get Aspartame Approved by FDA:
The FDA task force observed laboratory methods at Searle from April 25 toAugust 4, l977. The Bressler Report (named for team leader JeromeBressler), identified major discrepancies including "substantial differences between gross observation on pathology sheets when compared with those submitted to the FDA" in a rat toxicology test of aspartame. (FDA, Bressler Report, Investigation of Searle Laboratories, 8/7/77)
According to the Bressler Report, one rat even appeared to have been resurrected.It stated: "Observed records indicated that animal A23LM was alive at week88, dead from week 92 to week 104, alive at week 108, and dead at week 112."Sloppy Laboratory Practices by G.D.Searle applicant:
The actual meal fed to the rats was also in question. Raymond Schroeder, a former Searle employee, said in an FDA interview on July 13, l977 that "the particles of DKP were large enough to allow the rats to discriminate between the DKP and the basal diet."
Dr. John Olney, psychiatrist, neuropathologist and professor at Washington University in St. Louis, found: 12 brain tumors in 320 dosed rats and nonein 120 control rats when he examined FDA files on aspartame (aka: NutraSweet, Equal, Neotame, Canderel, etc.) animal studies in l978. Olney advised that the high number of brain tumors was unusual.
Olney voiced another concern based on his research. He showed that whenglutamate and aspartic acid are ingested together each agent augments theneurotoxic effects of the other.
Olney, along with consumer attorney James Turner, (co-founder of Aspartame Consumer Safety Network), initiated court action over aspartame. In a l986 interview, Turner said he had battled approval of aspartame 15 years. Because, "It is hurting people".
The late Dr. M. Adrian Gross, an FDA toxicologist, in sworn testimony, againstaspartame in the August 1, l985 Congressional Record.
Gross, who took part in on site investigations at G.D.Searle laboratories, said the studies carried out by Searle to show the safety of aspartame were "to a large extent unreliable." He said "at least one of those studies has established beyond any reasonable doubt that aspartame is capable ofinducing brain tumors in experimental animals and that this is ofextremely high significance."
(Congressional Record SID835:131 Aug 1,l985)
Gross also testified that because aspartame is capable of producing braintumors and brain cancer, FDA should not have been able to set an allowabledaily intake (ADI) of the substance at any level.
He said at least one of Searle's tests "has established beyond any reasonabledoubt that aspartame is capable of inducing brain tumors in experimental animals and that this predisposition is of extremely highsignificance. In view of these indications that the cancer causing potential of aspartame is a matter that has been established way beyond any reasonable doubt, one might ask: What is the reason for the apparent refusal by the FDA to invoke, in the case of this food additive, the Delaney Amendment to the Food, Drug and Cosmetic Act (FDCA)?"
The Delaney Amendment makes it illegal to allow any residues of cancer causing chemicals in foods. In his concluding testimony Gross asked,"Given the (cancer causing potential of aspartame) how would the FDAjustify its position that it views a certain amount of aspartame as constituting an allowable daily intake or 'safe' level of it? Is that position in effect not equivalent to setting a 'tolerance' for this food additive and thus a violation of that law? And if the FDA elects to violate the law, who is left to protect the health of the public?"
(submitted by Aspartame Consumer Safety Network Co-Founder, Journalist & Talk Show Host, Mary Nash Stoddard, whose husband was diagnosed with Brain Cancer on Oct. 9, 1984 and died Jan. 5,1985, at age 42, leaving behind a widow and 3 children.
Mary has met personally with each of the researchers mentioned in this article, on many occasions.
Stoddard co-founded ACSN and Pilot Hotline (1987) and gave sworn testimony at the Nov.3, 1987 Sen.Hearing on The Safety of Aspartame. After researching Aspartame literature at U.T. Southwestern Medical School Library for many months, with her doctor and a neuropharmacologist researcher friend. She edited/published the first Toxicology Sourcebook on the sweetener: Deadly Deception Story of Aspartame (Odenwald Press 1998).
On March 12, 1992, Stoddard, a former appointed judge for the State of Texas, was officially qualified in courtroom proceedings in Lansing, Michigan, as an Expert Medical Witness on Aspartame Sweeteners.
Since that time, Stoddard has appeared as a keynote speaker in the U.S., Canada and Mexico, where she received a special award for her research, from the Government of Mexico, after giving the Keynote Address, at their national Conference on Sweeteners in Pto. Vallarta, in 1998.
Stoddard, with an impressive background in Broadcasting and Journalism, has helped produce television news segments for 60-Minutes, both here and in Australia and an hour long Documentary, in which she and James Turner, Esq. are featured, for French TV, in 2011. She has participated in over a dozen Aspartame related court cases and written articles for a law journal as well as cover stories for Extraordinary Science magazine of The Nikolai Tesla Society, articles in Flying Journals around the world and Low Carb Monthly magazine for her friend, the late Dr. Robert Atkins.
In the late nineties, she was the Spokesperson for AIM, International in the US and Canada.
In 1998, Stoddard was a member of the U.S. President's Select Committee on Food Safety, which also included representatives from: US FDA (Food and Drug Administration), USDA (US Department of Agriculture); EPA (US Environmental Protection Agency); CSPI (Center for Science in the Public Interest) and others.
The Hon. Mary Nash Stoddard has collected thousands of adverse reactions to the sweetener Aspartame, manyof which have been turned in to the FDA for their Adverse Reaction Monitoring System (ARMS) files.
Reports, including many from brain tumor patients or their spouses, include pilots and others.
Stoddard is quick to remind us, her battle is with the FDA, as team Turner and Stoddard fight for recall and retesting as a drug, for Aspartame, which is how it was discovered - as a drug for peptic ulcers.
And, it all began when her husband, Mike, succumbed to Brain Cancer in 1985 and her research at one of the nation's top Medical Schools, which showed how Aspartamecaused Brain Tumors in the laboratory.
In 1998, in a career-defining moment, Stoddard was a paid Guest Lecturer at that same prestigious Medical School, as the first layperson ever to teach the class.###
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April 19, 2012
April 17, 2012
Presenting:ASPARTAME CONSUMER SAFETY NETWORK CO-FOUN...
Presenting:
ASPARTAME CONSUMER SAFETY NETWORK CO-FOUNDER, James Turner, Esq.
Mary Nash Stoddard
April 2012 -- James Turner, a long time Washington D.C. consumer crusader, began his public advocacy career as one of [Ralph] Nader's Raiders. Food safety and the regulatory process were subjects Turner knew a lot about. In the late sixties, he wrote the influential and best selling exposé of the food industry called "The Chemical Feast." Turner established his reputation as a regulatory pit bull when he fought to have cyclamate taken off the FDA's Generally Recognized As Safe (GRAS) list.
Turner determined to vigorously fight aspartame's approval, going through the proper regulatory channels. He took this battle on, largely at his own expense, because he was convinced influence peddling in Washington was behind aspartame's gaining FDA approval.
This isn't the first time Turner and Dr. Olney have had conflicts with Searle. Turner and Olney first joined forces in the late sixties, during the Senate hearings about MSG in baby foods. A few years later, when Olney learned Searle was developing aspartame for use as an artificial sweetener, he became alarmed and contacted his friend, James Turner, immediately.
Olney was worried because aspartic acid (one of three components of aspartame) had very similar properties to glutamic acid (an ingredient of monosodium glutamate, aka MSG) and in his ground breaking research with glutamate, he had shown it to cause brain lesions in infant rats.
Olney met with Searle brass, in order to present his concerns to them, regarding aspartame. Searle supplied Olney with aspartame so he could conduct experiments on the sweetener's safety. Olney fed aspartame to infant rats and observed the same results as he did with glutamate. (Olney has stated that glutamic acid and aspartic acid are virtually interchangeable in their biological effects in humans.) Aspartame caused brain lesions in the experiments with laboratory rats. According to Olney, aspartame caused a loss of neurons, and was responsible for stunted and retarded growth of: pituitary glands, testes and ovaries in animal experiments. Turner says when he and Olney met with Searle officials before aspartame's approval to inform them about the results of Olney's studies, Searle officials "listened politely" and told them they would get back to them. Turner and Olney never heard anything more from Searle.
Olney, a conservative scientist, is adamant when he says "there is no margin of safety for aspartame in a child's diet."
Turner and Olney decided to fight aspartame's approval. Representing a Washington, D.C. public interest group, Consumer Nutrition Institute (CNI), Turner and Olney filed formal objections with the US Food and Drug Administration (FDA.) They challenged the validity of some of the key aspartame safety tests, submitted to FDA by the applicant, G.D. Searle. They presented animal studies by Olney and others, showing evidence aspartame causes brain damage, brain tumors, seizures and definite changes in brain chemistry. Turner and Olney were especially concerned about the new sweetener's potential effects on fetuses and young children.
In April, 1975, the FDA scheduled a hearing body, specifically, a Public Board of Inquiry (PBOI), to review the objections to aspartame. While preparing for the PBOI, Dr. Olney examined the FDA files, which contained Searle's "Safety Data Studies."
What Olney discovered buried in those files would obsess him for years to come. He was shocked, when he found results of aspartame feeding experiments, conducted by Searle, which showed an unusually high incidence of brain tumors in rats that ingested the sweetener. There were absolutely no tumors in the control rats.
Olney was even more concerned when he reviewed a long term study of baby monkeys, which Searle researchers were feeding aspartame and milk. Of the seven monkeys, one died and five others had grand mal seizures. Jim Turner, who also looked at the seizure tests, was astonished when Searle scientists claimed these monkey studies proved aspartame's safety - since only the monkeys who received high doses of aspartame had seizures. The monkeys ingesting low doses did not experience seizures. Therefore, the company (G.D. Searle) argued and the FDA agreed - aspartame was "safe."
Turner and Olney worried that when children used NutraSweet (aspartame) products there was no way to control how much NutraSweet they ingested. Searle had not tested aspartame on humans. Safe dosage data for children was not available. Turner and Olney insisted that if children ingested too many products containing NutraSweet, they could easily cross the threshold that would trigger seizures.###submitted by: Mary Nash Stoddard/author Deadly Deception Story of Aspartame. (Co-Founder, with Jas. Turner, of Aspartame Consumer Safety Network and Pilot Hotline since 1987)
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April 15, 2012
ASPARTAME FACT SHEET (Email, Print and Distribute)A...
ASPARTAME FACT SHEET (Email, Print and
Distribute)
Aspartame is the name for an artificial, non-saccharide sweetener. In the European Union, it is known under the E number (additive code) E951. Aspartame is the methyl ester of a phenylalanine/aspartic acid dipeptide. It has been the subject of controversy since its initial (rescinded because of the brain tumor issue) approval in 1974. MarketingThis sweetener is marketed under a number of trademark names, including Equal, NutraSweet, and Canderel, and is an ingredient of approximately 6,000 consumer foods and beverages sold worldwide, including (but not limited to) diet sodas and other soft drinks, instant breakfasts, breath mints, cereals, sugar-free chewing gum, cocoa mixes, frozen desserts, gelatine desserts, juices, laxatives, multivitamins, milk drinks, pharmaceutical drugs and supplements, shake mixes, tabletop sweeteners, teas, instant coffees, topping mixes, wine coolers and yogurt. It is provided as a table condiment in some countries. It is also used in some brands of chewable vitamin supplements, children's vitamins and medications. It is common in sugar-free chewing gum and has now been found in some chewing gum that is not sugar free. However, aspartame is not ever suitable for baking because it always breaks down when heated and loses much of its sweetness. Aspartame is also one of the sugar substitutes used by people with diabetes."Aspartame is, by far, the most dangerous substance on the market that is added to foods."--Mary Nash Stoddard/author Deadly Deception Story of Aspartame; <http://www.aspartamesafety.com/>.Aspartame is the technical name for the brand names NutraSweet, Equal, Spoonful, and Equal-Measure, etc. It was discovered by accident in 1965 when James Schlatter, a chemist of G.D. Searle Company, was testing an anti-ulcer drug.
Aspartame was approved for tabletop use, in 1981 and for liquids and carbonated beverages in 1983. It was originally approved for tabletop use on July 26, 1974, but objections filed by neuroscience researcher Dr John W. Olney and Consumer attorney James Turner in August 1974 as well as investigations of G.D. Searle's research practices caused the U.S. Food and Drug Administration (FDA) to put approval of aspartame on hold (December 5, 1974). In 1985, Monsanto purchased G.D. Searle and made Searle Pharmaceuticals and The NutraSweet Company separate subsidiaries.
Aspartame accounts for over 75 percent of the adverse reactions to food additives reported to the FDA by Dallas-based Aspartame Consumer Safety Network. Many of these reactions are very serious including seizures and death. A few of the 92 documented symptoms listed in the report as being caused by aspartame include: Headaches/migraines, dizziness, seizures, nausea, numbness, muscle spasms, weight gain, rashes, depression, fatigue, irritability, tachycardia, insomnia, vision problems, hearing loss, heart palpitations, breathing difficulties, anxiety attacks, slurred speech, loss of taste, tinnitus, vertigo, memory loss, and joint pain.According to researchers and physicians studying the adverse effects of aspartame, the following chronic illnesses can be triggered or worsened by ingesting of aspartame:(2) Brain tumors, multiple sclerosis, epilepsy, chronic fatigue syndrome, parkinson's disease, alzheimer's, mental retardation, lymphoma, birth defects, fibromyalgia, and diabetes.
Aspartame is made up of: Phenylalanine; Aspartic Acid and Methanol (wood alcohol). In heat and at body temperature, Aspartame breaks down further into these toxic chemicals: Formaldehyde (embalming fluid); Formic Acid (venom in ant/insect stings) and Diketopiperazine (DKP - Brain Tumor Agent).What Is Aspartame Made Of?Aspartic Acid (40 percent of Aspartame)Dr. Russell L. Blaylock, a professor of neurosurgery at the Medical University of Mississippi, published a book thoroughly detailing the damage that is caused by the ingestion of excessive aspartic acid from aspartame. Blaylock makes use of almost 500 scientific references to show how excess free excitatory amino acids such as aspartic acid and glutamic acid (about 99 percent of monosodium glutamate (MSG) is glutamic acid) in our food supply are causing serious chronic neurological disorders and a myriad of other acute symptoms.How Aspartic Acid (and Glutamic Acid) ( Both are interchangeable in affects on body) Cause DamageAspartic Acid and glutamic acids act as neurotransmitters in the brain by facilitating the transmission of information from neuron to neuron. Too much aspartate or glutamate in the brain kills certain neurons by allowing the influx of too much calcium into the cells. This influx triggers excessive amounts of free radicals, which kill the cells. The neural cell damage that can be caused by excessive aspartate and glutamate is why they are referred to as "excitotoxins." They "excite" or stimulate the neural cells to death.
Aspartic acid is an amino acid. Taken in its free form (unbound to proteins) it significantly raises the blood plasma level of aspartate and glutamate. The excess aspartate and glutamate in the blood plasma shortly after ingesting aspartame or products with free glutamic acid (glutamate precursor) leads to a high level of those neurotransmitters in certain areas of the brain.
The blood brain barrier (BBB), which normally protects the brain from excess glutamate and aspartate as well as toxins, 1) is not fully developed during childhood, 2) does not fully protect all areas of the brain, 3) is damaged by numerous chronic and acute conditions, and 4) allows seepage of excess glutamate and aspartate into the brain even when intact.
The excess glutamate and aspartate slowly begin to destroy neurons. Known as a cumulative effect. The large majority (75 percent or more) of neural cells in a particular area of the brain are killed before any clinical symptoms of a chronic illness are noticed. A few of the many chronic illnesses that have been shown to be contributed to by long-term exposure to excitatory amino acid damage include:Multiple sclerosis (MS)ALSMemory lossHormonal problemsHearing lossEpilepsyAlzheimer's diseaseParkinson's diseaseHypoglycemiaAIDSDementiaBrain lesionsNeuroendocrine disordersThe risk to infants, children, pregnant women, the elderly and persons with certain chronic health problems from excitotoxins are great. Even the Federation of American Societies for Experimental Biology (FASEB), which usually understates problems and mimics the FDA party-line, recently stated in a review that:
"It is prudent to avoid the use of dietary supplements of L-glutamic acid by pregnant women, infants, and children. The existence of evidence of potential endocrine responses, i.e., elevated cortisol and prolactin, and differential responses between males and females, would also suggest a neuroendocrine link and that supplemental L-glutamic acid should be avoided by women of childbearing age and individuals with affective disorders."
Don't forget: Aspartic acid from aspartame has the same deleterious effects on the body as glutamic acid.
The exact mechanism of acute reactions to excess free glutamate and aspartate is currently being debated. As reported to the FDA, those reactions include: Headaches/migrainesNauseaAbdominal painsFatigue (blocks sufficient glucose entry into brain)Sleep problemsVision problemsAnxiety attacksDepressionAsthma/chest tightnessOne common complaint of persons suffering from the effect of aspartame is memory loss. Ironically, in 1987, G.D. Searle, the manufacturer of aspartame, undertook a search for a drug to combat memory loss caused by excitatory amino acid damage. Blaylock is one of many scientists and physicians who are concerned about excitatory amino acid damage caused by ingestion of aspartame and MSG.
A few of the many experts who have spoken out against the damage being caused by aspartate and glutamate include Adrienne Samuels, Ph.D., an experimental psychologist specializing in research design. Another is Olney, a professor in the department of psychiatry, School of Medicine, Washington University, a neuroscientist and researcher, and one of the world's foremost authorities on excitotoxins. (He informed Searle in 1971 that aspartic acid caused holes in the brains of mice.) Phenylalanine (50 percent of aspartame) Phenylalanine is an amino acid normally found in the brain. Persons with the genetic disorder phenylketonuria (PKU) cannot metabolize phenylalanine. This leads to dangerously high levels of phenylalanine in the brain (sometimes lethal). It has been shown that ingesting aspartame, especially along with carbohydrates, can lead to excess levels of phenylalanine in the brain even in persons who do not have PKU. There were 20 million unidentified carriers of the PKU gene in the U.S. in 1987.
This is not just a theory, as many people who have eaten large amounts of aspartame over a long period of time and do not have PKU have been shown to have excessive levels of phenylalanine in the blood. Excessive levels of phenylalanine in the brain can cause the levels of serotonin in the brain to decrease, leading to emotional disorders such as depression, sleep and menstrual disorders. It was shown in human testing that phenylalanine levels of the blood were increased significantly in human subjects who chronically used aspartame.
Even a single use of aspartame raised the blood phenylalanine levels. In sworn testimony before the U.S. Congress, Dr. Louis J. Elsas showed that high blood phenylalanine can be concentrated in parts of the brain and is especially dangerous for infants and fetuses. He also showed that phenylalanine is metabolised much more effeciently by rodents than by humans. One account of a case of extremely high phenylalanine levels caused by aspartame was recently published the "Wednesday Journal" in an article titled "An Aspartame Nightmare." John Cook (a Chicago Law Enforcement Officer), began drinking six to eight diet drinks every day. His symptoms started out as memory loss and frequent headaches. He began to crave more aspartame-sweetened drinks. His condition deteriorated so much that he experienced wide mood swings and violent rages. Even though he did not suffer from PKU, a blood test revealed a phenylalanine level of 80 mg/dl. He also showed abnormal brain function and brain damage. After he kicked his aspartame habit, his symptoms improved dramatically.
Early studies measuring phenylalanine buildup in the brain were flawed. Investigators who measured specific brain regions and not the average throughout the brain notice significant rises in phenylalanine levels. Specifically the hypothalamus, medulla oblongata, and corpus striatum areas of the brain had the largest increases in phenylalanine. Excessive buildup of phenylalanine in the brain can cause schizophrenia or make one more susceptible to seizures.
Therefore, long-term, excessive use of aspartame may provide a boost to sales of serotonin reuptake inhibitors such as Prozac and drugs to control schizophrenia, manic depression and seizures. Methanol (wood alcohol/toxin) (11 percent of Aspartame molecule) Methanol (wood alcohol) is a deadly poison. Some people may remember methanol as the poison that has caused some "skid row" alcoholics to end up blind or dead. Methanol is gradually released (beginning in the buccal mucosa glands in the mouth, to go rapidly into the bloodstream, bypassing the normal digestive system filters) and then in the small intestine (for every molecule of Aspartame a molecule of Methanol is released into the system) the methanol from Aspartame encounters the enzyme chymotrypsin.
The absorption of methanol into the body is sped up considerably when free methanol is ingested. Free methanol is created from aspartame when it is heated to above 86 Fahrenheit (30 Centigrade). This would occur when aspartame-containing product is improperly stored or when it is heated (e.g., as part of a "food" product such as Jello). Good to remember, body temperature is 98.6 deg. Fahrenheit.
Methanol breaks down into formic acid and formaldehyde in the body. Formaldehyde is a deadly neurotoxin. An EPA assessment of methanol states that methanol "is considered a cumulative poison due to the low rate of excretion once it is absorbed. In the body, methanol is oxidized to formaldehyde and formic acid; both of these metabolites are toxic." They recommend a limit of consumption of 7.8 mg/day. A one-liter (approx. 1 quart) aspartame-sweetened beverage contains about 56 mg of methanol. Heavy users of aspartame-containing products consume as much as 250 mg of methanol daily or 32 times the EPA limit.
Symptoms from methanol poisoning include headaches, ear buzzing, dizziness, nausea, gastrointestinal disturbances, weakness, vertigo, chills, memory lapses, numbness and shooting pains in the extremities, behavioral disturbances, and neuritis. The most well known problems from methanol poisoning are vision problems including misty vision, progressive contraction of visual fields, blurring of vision, obscuration of vision, retinal damage, and blindness. Formaldehyde is a known carcinogen, causes retinal damage, interferes with DNA replication and causes birth defects.
Due to the lack of a couple of key enzymes, humans are many times more sensitive to the toxic effects of methanol than animals. Therefore, tests of aspartame or methanol on animals do not accurately reflect the danger for humans. As pointed out by Dr. Woodrow C. Monte, director of the food science and nutrition laboratory at Arizona State University, "There are no human or mammalian studies to evaluate the possible mutagenic, teratogenic or carcinogenic effects of chronic administration of methyl alcohol."
Dr. Monte was so concerned about the unresolved safety issues that he filed suit with the FDA requesting a hearing to address these issues. He asked the FDA to "slow down on this soft drink issue long enough to answer some of the important questions. It's not fair that you are leaving the full burden of proof on the few of us who are concerned and have such limited resources. You must remember that you are the American public's last defense. Once you allow usage (of aspartame) there is literally nothing I or my colleagues can do to reverse the course. Aspartame will then join saccharin, the sulfiting agents, and God knows how many other questionable compounds enjoined to insult the human constitution with governmental approval." Shortly thereafter, the Commissioner of the FDA, Arthur Hull Hayes, Jr., approved the use of aspartame in carbonated beverages, he then left for a position with G.D. Searle's public relations firm, Burson Marsteller, for a reported thousand dollars a day consulting fee. Dr. Hays later died of Pancreatic Cancer, one of the identified diseases Aspartame triggered in laboratory testing.
It has been pointed out that some fruit juices and alcoholic beverages contain small amounts of methanol. It is important to remember, however, that methanol never appears alone. In every case, ethanol is present, usually in much higher amounts. Ethanol is an antidote for methanol toxicity in humans. The troops of Desert Storm were "treated" to large amounts of aspartame-sweetened beverages, which had been heated to over 86 degrees F in the Saudi Arabian sun. Many of them returned home with numerous disorders similar to that which has been seen in persons who have been chemically poisoned by formaldehyde. The free methanol in the beverages may have been a contributing factor in these illnesses. Other breakdown products of aspartame such as DKP (discussed below) may also have been a factor.
In a 1993 act that can only be described as "unconscionable," the FDA approved aspartame as an ingredient in numerous food items that would always be heated to above 86 degree F (30 degree C). Diketopiperazine (DKP) DKP is a breakdown product of aspartame metabolism. DKP has been implicated in the occurrence of brain tumors. Olney noticed that DKP, when nitrosated in the gut, produced a compound that was similar to N-nitrosourea, a powerful brain tumor causing chemical. Some authors have said that DKP is produced after aspartame ingestion. I am not sure if that is correct. It is definitely true that DKP is formed in liquid aspartame-containing products during prolonged storage.
G.D. Searle conducted animal experiments on the safety of DKP. The FDA found numerous experimental errors occurred, including "clerical errors, mixed-up animals, animals not getting drugs they were supposed to get, pathological specimens lost because of improper handling," and many other errors. These sloppy laboratory procedures may explain why both the test and control animals had sixteen times more brain tumors than would be expected in experiments of this length.
In an ironic twist, shortly after these experimental errors were discovered, the FDA used guidelines recommended by G.D. Searle to develop the industry-wide FDA standards for good laboratory practices.
DKP has also been implicated as a cause of uterine polyps and changes in blood cholesterol by FDA Toxicologist Dr. Jacqueline Verrett in her testimony before the U.S. Senate.
Information used in this article was taken from the pages of:
Deadly Deception Story of Aspartame by Mary Nash Stoddard
<http://aspartamesafety.com/web/deadly-deception/>
Stoddard's POV <http://marystod.blogspot.com/>
Follow marystod on Twitter: <http://twitter.com/#!/marystod/>
