|U.S. suppresses and falsifies science (16/2/2008)|
1.Top Scientists Want Research Free From Politics NOTE: Worth remembering that the approval of GMOs in the United States by the Food and Drug Administration (FDA), based on a misrepresentation of the facts and a massive cover up of FDA scientists' warnings (item 2), occurred well before the Bush Administration came to office, as did the equally controversial approval of Monsanto's GM hormone rBGH (aka rBST). As Anthony Robbins, professor of medicine at Tufts University and former director of the National Institute for Occupational Safety and Health, notes in this article, 'Although surely the worst, the Bush Administration is not the first, nor will it be the last [U.S.] administration to mistreat and misuse science and scientists.' (item 1)
1.Top Scientists Want Research Free From Politics
NOTE: Worth remembering that the approval of GMOs in the United States by the Food and Drug Administration (FDA), based on a misrepresentation of the facts and a massive cover up of FDA scientists' warnings (item 2), occurred well before the Bush Administration came to office, as did the equally controversial approval of Monsanto's GM hormone rBGH (aka rBST).
As Anthony Robbins, professor of medicine at Tufts University and former director of the National Institute for Occupational Safety and Health, notes in this article, 'Although surely the worst, the Bush Administration is not the first, nor will it be the last [U.S.] administration to mistreat and misuse science and scientists.' (item 1)EXTRACTS: The [FDA's] policy boldly claimed that there was no information to indicate that GM foods were different or more risky than natural varieties. Since the American public generally trusts the FDA, people assumed that no such risks existed. But nearly a decade later, the agency's internal documents — made public for the first time through a lawsuit — told a different story. (item 2)
'At FDA morale stinks. Hundreds of people have either retired or quit in disgust. All the best people, who believed in working on behalf of public health, have gone.' - a congressional aide (item 2)
In another example, a microbiologist at the U.S. Department of Agriculture was prevented 11 times from publicizing his research about the dangers of bacteria in the air near massive pig farms in Iowa and Missouri — a big business that supplies America's pork. His research found that the bacteria are resistant to antibiotics. But his supervisor refused to allow him to discuss his results, saying in one memo to him: 'politically sensitive and controversial issues require discretion.' (item 1)
1.Top Scientists Want Research Free From Politics
BOSTON - Leading U.S. scientists called on Congress Thursday to make sure the next president does not do what they say the George W. Bush Administration has done: censor, suppress and falsify important environmental and health research.
'The next president and Congress must cultivate an environment where reliable scientific advice flows freely,' said Susan Wood, a former director of women’s research at the U.S. Food and Drug Administration (FDA). Wood resigned her post in 2005 in protest over the FDA's delay in getting emergency, over-the-counter birth control onto the market.
'Serious consequences can result when drug safety decisions are not based on the best available scientific advice from staff scientists and experts,' she said.
Wood joined a panel of prominent scientists in Boston - convened by the Union of Concerned Scientists, an activist group - to announce a joint statement asking Congress to protect scientific integrity. Among the more than 15,000 government scientists signing onto the statement are Harold Varmus, president of Memorial Sloan-Kettering Cancer Centre and former director of the National Institutes of Health (NIH); and Anthony Robbins, professor of medicine at Tufts University and former director of the National Institute for Occupational Safety and Health.
'Although surely the worst, the Bush Administration is not the first, nor will it be the last administration to mistreat and misuse science and scientists,' Robbins said. The White House itself has been directly involved in the suppression and falsification of science, Robbins stressed.
But interference from the White House is just part of the problem, said Francesca Grifo, a former government researcher and now a director at the Union of Concerned Scientists. Industry lobbyists are all over government agencies, trying to influence research that will impact their corporations, she said. 'These special interest groups are being given access at the highest level.'
'Government scientists have had their findings subjected to censorship and misrepresentation,' said Kurt Gottfried, professor of physics at Cornell University and a member of the Union of Concerned Scientists. 'The public and Congress have often been deprived of accurate and candid scientific information.'
'The pursuit of science in an open society has had a long and fruitful tradition in America,' Gottfried said. 'Unfortunately, this tradition has been violated in recent years by the government itself.'
The Union of Concerned Scientists has been tracking the Bush Administration’s activities within the scientific community. No fewer than 1,191 scientists employed at nine federal agencies have reported to the group that they fear retaliation from their superiors because the results of their research are threatening to corporate or other interests, according to Grifo.
'What we’ve been seeing is that when certain programs produce research results that are considered inconvenient they are being penalized by having their funding cut,' Grifo told IPS. One such program is an annual listing of pollutants released by private companies, called the Toxic Release Inventory.
'We have seen it undermined,' Grifo said. The NASA satellite research program Mission to Planet Earth, which documents environmental degradation, also has been the target of severe budget cuts, Grifo said.
'When science is falsified, fabricated or censored Americans’ health and safety suffer,' Grifo said.
This interference has been directed at climate change research, new birth control drugs, species protection, consumer safety studies and agricultural research, the scientists said.
The suppression of health data by the federal Environmental Protection Agency (EPA) may cost many people who were at Ground Zero in New York City — or lived nearby on Sep. 11 — their health, the scientists said. Following the attacks of Sep. 11, then-EPA administrator Christine Todd Whitman went before the public and safety personnel on numerous occasions and said that the dust hovering over Ground Zero and settling over New York was not harmful. Many rescue workers and local residents have since become gravely ill due to the toxicity of the air they breathed.
The fate of the Greater Sage grouse is unknown since a top government official interfered with scientific studies showing that the bird and its habitat needed protection from development, the scientists said. Julie MacDonald stalled the release of studies on the grouse by questioning the methodology and conclusions. An expert panel never saw the studies and so recommended the bird not be protected.
Robin Ingle, a former statistician with the Consumer Product Safety Commission, said the commission refused to warn the public about gross problems with products like all-terrain vehicles even when research made clear how dangerous they were. 'A political appointee at my agency prevented my research on all-terrain-vehicle safety from reaching the public, even when deaths and injuries occurred,' she said.
'It’s very important that scientific and mathematical research on consumer products be free of the push and pull of politics because you don’t want it to be biased in favour of the industry,' Ingle told IPS.
In another example, a microbiologist at the U.S. Department of Agriculture was prevented 11 times from publicizing his research about the dangers of bacteria in the air near massive pig farms in Iowa and Missouri — a big business that supplies America's pork. His research found that the bacteria are resistant to antibiotics. But his supervisor refused to allow him to discuss his results, saying in one memo to him: 'politically sensitive and controversial issues require discretion.'
2.Government By the Industry, For the Industry
Henry Miller was in charge of biotechnology issues at the FDA from 1979 to 1994. According to Miller, 'U.S. government agencies have done exactly what big agribusiness has asked them to do and told them to do.'  This chapter reveals how industry influence has dictated policy, and how the FDA ignored the recommendations by the majority of their own scientists by approving GM foods without requiring safety tests.
The biotech industry’s success with these government leaders became apparent on May 26, 1992 in the Indian Treaty Room of the Old Executive Building. There, Vice President Dan Quayle announced the Bush administration's new policy on genetically engineered food: 'The reforms we announce today will speed up and simplify the process of bringing better agricultural products, developed through biotech, to consumers, food processors and farmers. We will ensure that biotech products will receive the same oversight as other products, instead of being hampered by unnecessary regulation.' 
By 'receive the same oversight as other products,' Quayle meant that GM foods would be considered just as safe as natural, non-GM foods. And sidestepping 'unnecessary regulation' meant that the government would not require any safety tests or any special labels identifying the foods as genetically engineered. The rationale for this hands-off policy was spelled out in an FDA document dated three days after Quayle's announcement. 'The agency is not aware of any information showing that foods derived by these new methods differ from other foods in any meaningful or uniform way.'  Monsanto had what it wanted: government endorsement of safety, and no regulations that would interfere with its plans for rapid worldwide sales.
Political Science at the FDA
Attorney Michael Taylor was involved in the development of FDA policy. Prior to working at the FDA, Monsanto was his personal client. Taylor had helped Monsanto draft pro-biotech regulations that the industry would lobby for. While working for the FDA, Taylor could implement those laws himself. For Monsanto, there was no better person to step into a leadership role at the FDA.
Taylor did not simply fill a vacant position at the agency. In 1991 the FDA created a new position for him: Deputy Commissioner for Policy. He instantly became the FDA official with the greatest influence on GM food regulation, overseeing the development of government policy.
According to public interest attorney Steven Druker, who has studied the FDA’s internal files, 'During Mr. Taylor's tenure as Deputy Commissioner, references to the unintended negative effects of bioengineering were progressively deleted from drafts of the policy statement (over the protests of agency scientists), and a final statement was issued claiming (a) that [GM] foods are no riskier than others and (b) that the agency has no information to the contrary.'  In 1994, Taylor became the administrator at the Department of Agriculture's Food Safety and Inspection Service, where he was also involved in biotechnology issues. He later became Vice President for Public Policy at Monsanto.
When the FDA announced its policy, the public was not aware of any internal dissent. The policy boldly claimed that there was no information to indicate that GM foods were different or more risky than natural varieties. Since the American public generally trusts the FDA, people assumed that no such risks existed. But nearly a decade later, the agency's internal documents—made public for the first time through a lawsuit—told a different story.
Linda Kahl, an FDA compliance officer, protested that by 'trying to force an ultimate conclusion that there is no difference between foods modified by genetic engineering and foods modified by traditional breeding practices,' the agency was 'trying to fit a square peg into a round hole.' She insisted, 'the processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks.' 
One such expert was FDA microbiologist Louis Pribyl. 'There is a profound difference between the types of unexpected effects from traditional breeding and genetic engineering,' wrote Pribyl in a letter to James Maryanski, the FDA's biotech coordinator. Pribyl said that several aspects of gene splicing 'may be more hazardous.'  According to the New York Times, 'Dr. Pribyl knew from studies that toxins could be unintentionally created when new genes were introduced into a plant’s cells.'  Moreover, Pribyl wrote 'there is no certainty that [the breeders of GM foods] will be able to pick up effects that might not be obvious.' He declared, 'This is the industry's pet idea, namely that there are no unintended effects that will raise the FDA's level of concern. But time and time again, there is no data to back up their contention.' 
Pribyl was only one of many FDA scientists asked to provide input during the formulation of the FDA’s policy on genetically engineered food. According to Druker, records show that the majority of these scientists identified potential risks of GM foods. Druker was the main organizer of the lawsuit that forced the FDA documents into the public domain. His nonprofit organization, the Alliance for Bio-Integrity, was the lead plaintiff. Having sorted through tens of thousands of pages of FDA documents, he described the opinion of the agency’s scientists as follows: 'The predominant view was that genetic engineering entails distinct risks and that its products cannot be regarded as safe unless they have been confirmed to be so through appropriate feeding studies.' Druker says several scientists 'issued strong warnings.' 
The Toxicology Group, for example, warned that genetically modified plants could 'contain unexpected high concentrations of plant toxicants,' and described the reasons why these might be very difficult to identify.  Their director wrote, 'The possibility of unexpected, accidental changes in genetically engineered plants justifies a limited traditional toxicological study.' 
The Division of Food Chemistry and Technology outlined four potential dangers:
'Increased levels of known naturally occurring toxins'
'Appearance of new, not previously identified' toxins Increased tendency to gather 'toxic substances from the environment' such as 'pesticides or heavy metals'
'Undesirable alterations in the levels of nutrients'
They warned, 'unless genetically engineered plants are evaluated specifically for these changes,' these four 'may escape breeders’ attention.' The division recommended testing every GM food 'before it enters the marketplace.' 
Gerald Guest, the director of FDA’s Center for Veterinary Medicine (CVM) sent a letter to the FDA’s Biotech Coordinator, James Maryanski, saying that he and the other CVM scientists concluded that there is 'ample scientific justification' to require testing and review of each GM food before it is eaten by the public. He stated, 'CVM believes that animal feeds derived from genetically modified plants present unique animal and food safety concerns.' He pointed out that, 'residues of plant constituents or toxicants in meat and milk products may pose human food safety concerns.' 
In spite of repeated internal memos outlining the potential for increased health risks posed by this new technology, subsequent drafts of the FDA’s policy statement, overseen by Taylor, deleted more and more of the scientist’s input. In a fiery memo to Maryanski, Pribyl challenged the direction the policy statement had taken: 'What has happened to the scientific elements of this document? Without a sound scientific base to rest on, this becomes a broad, general, ‘What do I have to do to avoid trouble’-type document…. It will look like and probably be just a political document…. It reads very pro-industry, especially in the area of unintended effects.'
But while the FDA’s scientists were emphasizing caution and testing, its leaders were beholden to an altogether different lobbying effort. A March 1992 memo from FDA Commissioner David Kessler, confirmed the White House’s influence in the crafting of the agency’s policy. 'The approach and provisions of the policy statement are consistent with the general biotechnology policy established by the Office of the President…. It also responds to White House interest in assuring the safe, speedy development of the U.S. biotechnology industry.' 
But even the draft of the policy that Commissioner Kessler praised as White House-friendly was subject to further revision as it went up the political chain of command. A memo from the Office of the Assistant Secretary for Health, at the Department of Health & Human Services, expressed reservations about the length and depth of the policy statement’s concern for environmental effects of GM crops. The letter said, 'The extensive twelve page discussion seems to be…dangerously detailed and drawn-out.'  In the end, it was the political, rather than scientific considerations that prevailed.
The agency not only ignored its scientists, it claimed their concerns never existed. For example, the State Department’s Melinda Kimble, while negotiating GMO trade policy said, 'I want to make very clear that it is the position of the United States government that we do not believe there is a difference between GMO commodities and non-GMO commodities.'  Likewise, a March 2003 statement by Speaker of the House Hastert declared, 'There is general consensus among the scientific community that genetically modified food is no different from conventional food.' 
When the FDA documents eventually became public, Maryanski defended the agency's policy. On February 28, 2000, he told the OECD Conference on GM Food Safety in Edinburgh, Scotland that the FDA scientists had merely been asking questions about the various issues involved in bioengineered food. Maryanski was unpleasantly surprised when Druker, who was a member of the conference, stood up and invited the audience to read the FDA memos that were posted on his organization's website. They could see for themselves that the agency's scientists were not merely asking questions; many of their statements were quite emphatic about the unique risks of GM foods.
Maryanski, other FDA officials, and representatives throughout the U.S. government continue to claim that there is overwhelming consensus among scientists that GM foods are safe. In an October 1991 letter to a Canadian official, however, Maryanski himself had admitted that this was not true. He said, 'there are a number of specific issues… for which a scientific consensus does not exist currently, especially the need for specific toxicology tests.' Maryanski also said, 'I think the question of the potential for some substances to cause allergenic reactions is particularly difficult to predict.' 
Commenting on statements made by FDA scientists, the New York Times wrote. 'The scientists were displaying precisely the concerns that Monsanto executives from the 1980’s had anticipated -- and indeed had considered reasonable. But now, rather than trying to address those concerns, Monsanto, the industry and official Washington were dismissing them as the insignificant worries of the uninformed.' 
Many scientists who understood the dangers, however, were not convinced by the FDA's assurances. Geneticist David Suzuki, for example, said, 'Any politician or scientist who tells you these products are safe is either very stupid or lying. The experiments have simply not been done.'  A January 2001 report from an expert panel of the Royal Society of Canada likewise supported the conclusions of the FDA scientists. The report said it was 'scientifically unjustifiable' to presume that GM foods are safe. The report explains that the 'default prediction' for any GM foods is that 'expression of a new gene (and its products) … will be accompanied by a range of collateral changes in expression of other genes, changes in the pattern of proteins produced and/or changes in metabolic activities.' This could result in novel toxins or other harmful substances. The report emphasized the need for safety testing, looking for short and long-term human toxicity, allergenicity, and other health effects. The panel began their comprehensive 245-page report by quoting the editors of the UK’s Nature Biotechnology. 'The risks in biotechnology are undeniable, and they stem from the unknowable in science and commerce. It is prudent to recognize and address those risks, not compound them by overly optimistic or foolhardy behavior.' 
FDA veterinarian Richard Burroughs described the changes he saw at the FDA. 'There seemed to be a trend in the place toward approval at any price. It went from a university-like setting where there was independent scientific review to an atmosphere of 'approve, approve, approve.' He said, 'the thinking is, 'How many things can we approve this year?' Somewhere along the way they abdicated their responsibility to the public welfare.'  A congressional aide said, 'At FDA morale stinks. Hundreds of people have either retired or quit in disgust. All the best people, who believed in working on behalf of public health, have gone.' Dan Glickman, former Secretary of Agriculture, describes the government's pro-biotech mind-set. 'It was almost immoral to say that it wasn't good because it was going to solve the problems of the human race and feed the hungry and clothe the naked.' He said, 'You felt like you were almost an alien, disloyal, by trying to present an open-minded view…. So I pretty much spouted the rhetoric… It was written into my speeches.'