Gary Null's Blog, page 30

Ethical Dilemmas Contribute to 'Critical Weaknesses' in FDA Postmarket Oversight, Experts Say

 Ethical challenges are central to persistent "critical weaknesses" in the national system for ensuring drug safety, according to a commentary by former Institute of Medicine (IOM) committee members published August 22 in the New England Journal of Medicine.

With a caution against "reactive policymaking," committee co-chairs Ruth Faden, Ph.D., M.P.H., and Steven Goodman, M.D., M.H.S., Ph.D., with fellow committee member Michelle Mello, J.D., Ph.D., revisit the controversy over the antidiabetic drug Avandia that led to the formation of their IOM committee on monitoring drug safety after approval.

The Avandia postmarket trial, halted in September 2010, was "a lesson in how our current approach to the oversight of drug-safety and postmarketing research can fail both the public and the research participants," the authors write. With those lessons in mind, their independent commentary follows the May 2012 IOM report with a focus on the ethical challenges ahead.

The authors detail the IOM report's recommendations for maintaining the delicate balance of drug innovation and drug safety. Increased "fast-tracking" of drug approval for medical conditions with no effective treatment necessitates a counterbalance of increased postmarket oversight, the authors argue. They echo the IOM report's call for an independent ethics advisory board to the Food and Drug Administration (FDA), focused on postmarket research and safety surveillance.

"As the pace of the translation of discoveries from bench to bedside continues to intensify, so too does the imperative for thoughtful ethical governance throughout the lifecycle of a drug," the authors write.

The authors also amplify one of the IOM report's key ethics points -- the responsibility of the FDA to participants in postmarket research, particularly in randomized trials that determine which treatment they receive. The FDA has a unique ethical obligation to the welfare of research participants when requiring a postmarket study, the authors assert, which "cannot be handed off to contractors or the industry sponsor."

Read more.. 

http://www.sciencedaily.com/releases/...

Ed Bauman -- Studies Show Microwaves Drastically Reduce Nutrients In Food

I can remember the days growing up in the 1950's and 1960's, when we prepared foods without a microwave oven. Water was boiled on the stove. Chicken was baked in an oven. Vegetables were steamed, baked, or sautéed. Food was whole and fresh. Even a TV dinner was baked in the oven, which took about 15 minutes to warm. And then, modern science and technology brought us the microwave oven that could heat food rapidly, from 30 seconds to a couple of minutes.

The industry has claimed that microwave cooking protects the nutrient content of foods. Somehow, in tasting foods that came out of a microwave oven, the texture was changed as was the flavor. Foods cooked or reheated in microwave ovens became rubbery and lacked the savory smells and layered flavors that come from cooking foods slower and longer.

Nevertheless, people bought the convenience aspect, the speed, the simplicity of heating and eating prepared foods. The science, which has been supported by the food industry, has continued to claim the health benefits of microwave cooking. Recently, published data from reliable sources questions the health benefits of microwaved food.

Does this mean an occasional microwaved meal will be harmful? Not likely. But what about a steady diet of eating foods cooked at such a high heat? Do the sensitive compounds in food, such as amino acids, fatty acids, vitamins and phytonutrients change? It appears so. Read on to follow the scientific literature surrounding the depletion of our soil, foods, and health as a result of modern farming, food processing, microwave cooking, and not eating enough fresh, natural, uncooked, organic whole foods.

Three recent studies of historical food composition have shown 5-40% declines in some of the minerals in fresh produce, and another study found a similar decline in our protein sources (1)
A 1999 Scandinavian study of the cooking of asparagus spears found that microwaving caused a reduction in vitamins (3)
In a study of garlic, as little as 60 seconds of microwave heating was enough to inactivate its allinase, garlic's principle active ingredient against cancer (5)
A study published in the November 2003 issue of The Journal of the Science of Food and Agriculture found that broccoli "zapped" in the microwave with a little water lost up to 97%of its beneficial antioxidants. By comparison, steamed broccoli lost 11% or fewer of its antioxidants. There were also reductions in phenolic compounds and glucosinolates, but mineral levels remained intact (6).
A recent Australian study showed that micro- waves cause a higher degree of "protein unfolding" than conventional heating (2)
Microwaving can destroy the essential disease-fighting agents in breast milk that offer protection for your baby. In 1992, Quan found that microwaved breast milk lost lysozyme activity, antibodies, and fostered the growth of more potentially pathogenic bacteria (4).

Quan stated that more damage was done to the milk by microwaving than by other methods of heating, concluding: "Microwaving appears to be contraindicated at high-temperatures, and questions regarding its safety exist even at low temperatures."

Read more.. http://www.greenmedinfo.com/blog/stud...

Paula Alvarado -- A landmark ruling against agrochemicals in Argentina receives mixed reactions

Argentine activist Sofia Gatica did not win the Goldman Environmental Prize this year for a small reason: for more than a decade, she has been leading a joint complaint with neighbors from her town Ituzaingo, in Cordoba province, against producers who were spraying agrochemicals too close to the community, making people sick. (The public attorney claimed 169 people from the 5,000 neighbors got cancer from pollution from 2002 until 2010.)

Argentina being the third largest exporter of soybeans and a consumer of over 50 million gallons of glyphosate and endosulfan, her efforts were not small. In fact, she became the voice for a problem nobody wants to talk about.

Since the government depends on soy exports to collect taxes and keep the economy alive, the subject is not one eagerly discussed politically. There was a call by president Cristina Fernandez de Kirchner to create a commission to investigate agrochemicals in 2009, but its final recommendation, as IPS notes, was, "Because there is not enough data in Argentina on the effects of glyphosate on human health, it is important to promote further research."

The media is not crazy about it either, and you can see why by flipping the pages of the Country supplements from the nation's major newspapers, filled with ads from Monsanto et al. In 2009, a local scientist presented a study with evidence of the impact of glyphosate on amphibious embryos and received death threats plus an aggressive discredit campaign.

But this afternoon, Gatica and other environmental movements pushing the issue were preparing to receive a pat in the back. A court in Cordoba Province was going to give its final ruling on whether two farmers and an aviator were guilty of causing environmental damage and potential health hazards to the people of Ituzaingo.

Five hours after the initial time of the announcement, the verdict was in: one farmer was absolved due to lack of evidence, but the other and the aviator were found guilty and sentenced to three years of jail. Well, actually, conditional jail. Which means they can very much get out of doing any time, although they will be obliged to do social work.

Read more.. http://www.treehugger.com/environmental-policy/a-landmark-ruling-against-agrochemicals-in-argentina-receives-mixed-reactions.html

Stress May Cause Illness By Changing Genes

A new study suggests that acute psychological stress, which is known to increase the risk of physical and mental illness, may do so by altering the control of genes.

A report on the study, thought to be the first to show that stress alters the methylation of DNA and thus the activity of certain genes, appeared online in the journalTranslational Psychiatry on 14 August.

Researchers from the Ruhr-Universität Bochum (RUB), together with colleagues from Basel, Trier and London, looked at gene segments that are known to be involved with the control of biological stress.

One of the most important discoveries in genetics is epigenetics, or the "second code" that regulates gene activity.

Research is beginning to show that epigenetic changes could be involved in the development of some chronic diseases such as cancer or depression.

While the genome, the genetic code or DNA, for making a human being is more or less fixed once the sperm fertilizes the egg, it is the epigenome that decides how the blueprint is interpreted.

Think of the genome as being the construction manual for making all the proteins the body needs, and the epigenome as the construction or maintenance guy reading the manual: sometimes he will have off days when he is tired and makes mistakes, or just interprets the instructions differently.

Cells function by making proteins. Which proteins they produce depends on the cell type, which is set by genes, and the environment, which influences how the epigenome reads the genes. One way this happens is via methyl groups (CH3) that attach to sections of DNA: these can remain in place for quite a while, even after the cell divides.

Previous studies have shown that psychological trauma in early life and highly stressful events are associated with long-term methylation changes to DNA.

But what the researchers in this study wanted to find out was whether this also happens after acute psychological stress: for instance such as that experienced during a job interview.

 

Read more.. http://www.medicalnewstoday.com/artic...

Flavanol-rich cocoa may reduce blood pressure a bit

 Eating a daily dose of cocoa or dark chocolate - rich in plant compounds called flavanols - may lead to a slight drop in blood pressure for a short period of time, a fresh look at past research suggests.

Pulling data from 20 studies published over the last decade, researchers found that people who ate flavanol-rich cocoa products every day for a few weeks saw their blood pressure drop by about two or three points.

That's far less than the reduction people taking blood pressure lowering medication could expect, but it's on par with the effects of adding diet changes or exercise to their routine, according to the researchers.

That doesn't mean people should drop exercise in favor of chocolate, said Dr. Elizabeth Jackson, a cardiologist and assistant professor of medicine at the University of Michigan Health Systems in Ann Arbor.

"If I had to choose between cocoa and exercise, I would take the exercise," said Jackson, who was not involved in the new study.

"To me this says a little bit of dark chocolate isn't too bad, but you wouldn't want to go overboard with the calories and eat a pound of chocolate," she said.

SMALL REDUCTIONS

For the analysis, published in The Cochrane Library, Australian researchers searched several online databases to find randomized controlled trials - considered the "gold standard" of medical research - that compared people eating flavanol-rich cocoa products to people eating low-flavanol cocoa powder or products that contained none of the plant compounds.

While the researchers cannot say flavanols are responsible for lowering blood pressure in the study participants, the compounds - which are also found in foods such as green tea, berries and red wine - are linked to nitric oxide production in the body. Nitric oxide, according to the authors, helps relax blood vessels, which reduces blood pressure.

According to the American Heart Association, a person's systolic blood pressure (the top number) should be less than 120 millimeters of mercury (mm Hg), and their diastolic blood pressure (the bottom number) should be less than 80 mm Hg.

The 20 studies included in the review followed people who were generally healthy for two to 18 weeks.

Of 856 participants, 429 ate between 3 grams (g) and 100 g of dark chocolate or cocoa that contained anywhere from 30 milligrams (mg) to 1080 mg of flavanols, daily.

The other 427 people were put in comparison groups that ate low-flavanol cocoa powder or products that did not contain any flavanols.

At the end of the studies, those who ate the flavanol-rich dark chocolate or cocoa product saw their systolic blood pressure fall by roughly 2.8 mm Hg while their diastolic fell by 2.2 mm Hg.

There are, however, some limitations to the findings.

Read more.. http://www.nlm.nih.gov/medlineplus/ne...

Agence France-Presse -- Arctic cap on course for record melt: scientists

The Arctihttp://www.rawstory.com/rs/2012/08/22...

c ice cap is melting at a startlingly rapid rate and may shrink to its smallest-ever level within weeks as the planet’s temperatures rise, US scientists said Tuesday.

Researchers at the University of Colorado at Boulder said that the summer ice in the Arctic was already nearing its lowest level recorded, even though the summer melt season is not yet over.

“The numbers are coming in and we are looking at them with a sense of amazement,” said Mark Serreze, director of the National Snow and Ice Data Center at the university.

“If the melt were to just suddenly stop today, we would be at the third lowest in the satellite record. We’ve still got another two weeks of melt to go, so I think we’re very likely to set a new record,” he told AFP.

The previous record was set in 2007 when the ice cap shrunk to 4.25 million square kilometers (1.64 million square miles), stunning scientists who had not forecast such a drastic melt so soon.

The Colorado-based center said that one potential factor could be an Arctic cyclone earlier this month. However, Serreze played down the effects of the cyclone and said that this year’s melt was all the more remarkable because of the lack of special weather factors seen in 2007.

Serreze said that the extensive melt was in line with the effects of global warming, with the ice being hit by a double whammy of rising temperatures in the atmosphere and warmer oceans.

“The ice now is so thin in the spring just because of the general pattern of warming that large parts of the pack ice just can’t survive the summer melt season anymore,” he said.

Read more.. http://www.rawstory.com/rs/2012/08/22...

Samuel Epstein -- Japan Proceeding Without Nuclear Reactors

It has been almost 18 months since the disastrous meltdowns struck four nuclear reactors at the Fukushima plant in northern Japan. While daily news footage of exploding reactor buildings, emergency workers dressed like spacemen, and officials sweeping radiation detectors over children's bodies have disappeared, the impact of Fukushima continues.

While the Fukushima story is no longer a page-one news story, people must still be aware of how incredibly devastating the meltdowns were. This was no minor leak, but one of the two worst atomic meltdowns in history (Chernobyl was the other). Earlier meltdowns involved damage to just one reactor core; Fukushima destroyed three. Previous meltdowns never affected nuclear waste pools, but the Fukushima unit 4 pool sustained extensive damage and huge leaks. Other meltdowns contaminated the reactor's water source, usually a river; Fukushima poured its toxic chemicals into the Pacific, the world's largest ocean.

The question of how much radioactivity escaped into the air and water is an elusive question; estimates range between 20% and 300% of the Chernobyl amount. Likewise, we're still finding out how much of the radioactive gases and particles entered the air, water, and food. Measurements documenting extremely high levels have been taken near the Fukushima plant, an area evacuated by residents. But elevated radiation levels have been found in other parts of Japan. Because it took about six days for the radioactive plume to reach the West Coast and 18 days to circle the Northern Hemisphere, above-normal levels were also found in the U.S. and other nations, months after the meltdowns.

Of course, the most critical Fukushima questions involve harm to humans. How many workers at the plant became sick? How many local residents? How many living further away in Japan? Did infants and young children suffer more than adults? What types of diseases did they suffer from? But the biggest questions have generated the biggest silence. Thus far, there have been no official reports or publicly-announced data from Japanese health authorities on changes in disease and death rates after the meltdowns.

Buried in the many documents the Japanese health ministry places on its website is the monthly estimate of deaths. During the 12 months following Fukushima, the number of deaths for all of Japan jumped 57,900 above than the prior year. About 19,200 were additional deaths from accidents, almost all from the immediate impact of the earthquake and tsunami, but that left 38,700 excess deaths from other causes -- with no immediate explanation. While all of these cannot automatically be attributed to radiation exposure, they should be taken seriously and become the subject of extensive health studies.

Aside from the changes in health, Fukushima has also had a major impact on public policy. Within days of the meltdowns, Germany shut some reactors, four of them permanently; the Merkel government then announced a plan to phase out all remaining reactors by 2022. Belgium and Switzerland soon followed with similar phase-out plans. Italy, which has no operating reactors, placed a moratorium on plans to build new ones. Newly-elected French president Hollande campaigned on a pledge to drop the percent of French electricity from nuclear power from 75% to 50% by 2030.

Read more.. http://www.huffingtonpost.com/samuel-...

Chris Hedges -- The War in the Shadows

A Swedish documentary filmmaker released a film last year called “Last Chapter—Goodbye Nicaragua.” In it he admitted that he unknowingly facilitated a bombing, almost certainly orchestrated by the Sandinista government of Nicaragua, which took the lives of three reporters I worked with in Central America. One of them, Linda Frazier, was the mother of a 10-year-old son. Her legs were torn apart by the blast, at La Penca, Nicaragua, along the border with Costa Rica, in May of 1984. She bled to death as she was being taken to the nearest hospital, in Ciudad Quesada, Costa Rica.

The admission by Peter Torbiornsson that he unwittingly took the bomber with him to the press conference was a window into the sordid world of espionage, terrorism and assassination that was an intimate part of every conflict I covered. It exposed the cynicism of undercover operatives on all sides, men and women who lie and deceive for a living, who betray relationships, including between each other, who steal and who carry out murder. One knows them immediately. Their ideological allegiances do not matter. They have the faraway eyes of the disconnected, along with nebulous histories and suspicious and vague associations. They tell incongruous personal stories and practice small deceits that are part of a pathological inability to tell the truth. They can be personable, even charming, but they are also invariably vain, dishonest and sinister. They cannot be trusted. It does not matter what side they are on. They were all the same. Gangsters.

All states and armed groups recruit and use members of this underclass. These personalities gravitate to intelligence agencies, terrorist cells, homeland security, police departments, the special forces and revolutionary groups where they can live a life freed from moral and legal constraints. Right and wrong are banished from their vocabulary. They disdain the constraints of democracy. They live in this nebulous underworld to satisfy their lusts for power and violence. They have no interest in diplomacy and less in peace. Peace would put them out of business; for them it is simply the temporary absence of war, which they are sure is inevitable. Their job is to use violence to purge the world of evil. And in the United States they have taken as hostages our diplomatic service and our foreign policy establishment. The CIA has become a huge private army, as Chalmers Johnson pointed out in his book “Nemesis: The Last Days of the American Republic,” that is “unaccountable to the Congress, the press or the public because everything it does is secret.” C. Wright Mills called the condition “military metaphysics”—“the cast of mind that defines international reality as basically military.”

Since the attacks of 9/11, the U.S. Special Operations Command (USSOCOM)—which includes the Green Berets, the Army Rangers and the Navy SEALs—has seen its budget quadrupled. There are now some 60,000 USSOCOM operatives, whom the president can dispatch to kill without seeking congressional approval or informing the public. Add to this the growth of intelligence operatives. As Dana Priest and William M. Arkinreported in The Washington Post, “Twenty-four [new intelligence] organizations were created by the end of 2001, including the Office of Homeland Security and the Foreign Terrorist Asset Tracking Task Force. In 2002, 37 more were created to track weapons of mass destruction, collect threat tips, and coordinate the new focus on counterterrorism. That was followed the next year by 36 new organizations; and 26 after that; and 31 more; and 32 more; and 20 or more each in 2007, 2008, and 2009. In all, at least 263 organizations have been created or reorganized as a response to 9/11.”

Read more.. http://www.truthdig.com/report/item/the_war_in_the_shadows_20120820/

Government Has Been Covering up Radiation Danger for 67 Years

The U.S. and other governments have been covering up nuclear meltdowns for fifty years to protect the nuclear power industry.

It turns out that the U.S. tried to cover up the destructive nature of radiation produced by nuclear weapons 67 years ago. As Democracy Now reports:

The army was well aware in 1943 of the enormous potential for radiation dangers to civilians and military personnel as a result of the use of radioactive weapons ….

[The New York Times] was essentially putting out the official government narrative [regarding the bombing of Hiroshima and Nagasaki], which is that atomic radiation is not harmful, is not a major byproduct of the nuclear weapons program. You know, it’s only the blast that has essentially a very short impact. The reason that this has importance is that for really a half century, this narrative became the government’s response to all protests against nuclear power, the nuclear weapons programs of the 1950s and 1960s and the Cold War. So, [The New York Times] essentially set the table that the government was to occupy for the next half century as they disputed any attempt to rein in, you know, the rapid acceleration of nuclear weapons and power programs.

Nothing has changed. Governments worldwide continue to this day to cover up the amount – and health effects – of radiation released by military and energy facilities.

And the same considerations which drove the cover up in 1945 are still driving it. The archaic uranium reactor designs developed more than 40 years ago are good for making bombs.

 Read more.. http://globalresearch.ca/index.php?co...

Susanne Posel -- Banks Can Legally Steal Customer Funds From Private Checking Accounts

In 2007, the Sentinel Management Group (SMG) collapsed, leaving many customer segregated funds lost after they had been used as collateral. After a plethora of lawsuits and creditor claims, a decision earlier this month in the 7th Circuit Court placed the banking cartels ahead of customer claims for funds returned. Essentially, the Bank of New York Mellon (BNYM) sued to be first in line for return on stolen customer account monies – and won the right by the US court system.

In the mainstream media (MSM), the SMG collapse and subsequent ruling in favor of BNYM was touted as a difficulty “for customers to recoup money lost”.

SMG, a Chicago-based futures broker, had stolen more than $500 million in segregated customer funds to use as collateral on a loan to BNYM for in-house proprietary trading operations. Their books were audited by the National Futures Association (NFA), however the NFA admitted that they could not understand the convoluted mess they were provided by SMG to sign off on. And yet they did; and approved the audit.

BNYM sued SMG to re-coup any monies owed to them. However, these monies were customer segregated funds that SMG stole and re-hypothecated.

In federal court, John D. Tinder, US Circuit Court Judge ruled “that Sentinel failed to keep client funds properly segregated is not, on its own, sufficient to rule as a matter of law that Sentinel acted ‘with actual intent to hinder, delay, or defraud’ its customers.”

This means that once a banking customer deposits their money into an account with a bank, the funds become property of the bank. The customer, at the point of deposit, relinquishes all rights to that money regardless of any laws in place, legal assurances, claims or guarantees; and this extends from investments to private checking accounts.

Once the bank has physical possession of your money, they own it and can use it for any means they deem fit. The veil has been lifted on separation of customer and bank funds. They are now legally co-mingled.

The bank could use it as collateral (as SMG did), to pay off debts, or place it on the stock market to bump up their trading with extra cash. And in the event that the customer allocated funds are lost, the bank does not owe the customer the money back.

Essentially, once you deposit money in your bank account it is gone.

Fred Grede, SMG trustee remarked: “I don’t think that’s what the Commodity Futures Trading Commission had in mind. It does not bode well for the protection of customer funds.”

Read more.. http://occupycorporatism.com