As you sow so shall you reap

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Chapter 1: A Lesson From Overseas

When eminent scientist Arpad Pusztai went public about his accidental discovery that genetically modified (GM) potatoes severely damage the immune system and organs of rats, he was suspended from the prestigious Scottish research institute where he had worked for thirty-five years. He was silenced with threats of a lawsuit while the Institute denied or distorted his findings.

In the ensuing war over public opinion, biotech advocates tried to spin the science in favor of GM foods, but were thwarted at each attempt by leaked documents and compelling evidence. Pusztai, who describes this chapter as “the most thorough and accurate report on the topic,” was ultimately vindicated when his potato study was published in the Lancet. His remains the only independent safety assessment in a peer-reviewed journal. It contrasts sharply with the handful of published industry studies, an analysis of which reveals how they were designed to avoid finding problems.

Excerpt:

When Susan answered the door, she was startled to see several reporters standing in front of her. Several more were running from their cars in her direction and she could see more cars and TV news vans parking along the street.

“But you all know that we can’t speak about what happened. We would be sued and—” [6]

“It’s OK now,” the reporter from Channel Four Television interrupted, waving a paper in front of her. “They’ve released your husband. He can talk to us.”

Susan took the paper. “Arpad, come here,” she called to her husband.

Arpad Pusztai (pronounced: Are-pod Poos-tie), a distinguished looking man in his late sixties, was already on his way. As his wife showed him the document, the reporters slipped past them into the house. But Arpad didn’t notice; he was staring at the paper his wife had just handed him. He recognized the letterhead at once—The Rowett Institute, Aberdeen, Scotland. It was one of the world’s leading nutritional institutes and his employer for the previous thirty-five years—until his sudden suspension seven months ago. And there it was, clearly spelled out. They had released their gag order. He could speak.

The document was dated that same day, February 16, 1999. In fact, less than twenty minutes before, thirty reporters had sat in the Rowett Institute press conference listening to its director, Professor Phillip James, casually mention that the restrictions on Dr. Pusztai’s speaking to the press had been lifted. Before James had finished his sentence, the reporters leaped for the door. They jumped into their cars and headed straight to the Pusztai’s house on Ashley Park North, an address most were familiar with, having virtually camped out there seven months earlier. Now those thirty reporters, with TV cameras and tape recorders, were piled into the Pusztai’s living room.

Arpad Pusztai read the document—twice. As he looked up, the reporters started asking him questions all at once. He smiled, and breathed more easily than he had in a long time. He had all but given up hope. Now he finally had the chance to share what he knew about the dangers of genetically engineered foods.

The story of Arpad Pusztai made headlines throughout Europe for months, alerting readers to some of the serious health risks of genetically modified (GM) foods. It was barely mentioned, however, in the U.S. press; the media watchdog group Project Censored described it as one of the ten most underreported events of the year. [7] In fact, major U.S. media avoided almost any discussion of the controversy over genetically modified organisms (GMOs) until May 1999. But that was all about saving the monarch butterfly from GM corn pollen, not about human food safety.

It wasn’t until the massive food recall prompted by StarLink corn that Americans were even alerted to the fact that they were eating GM foods everyday. Moreover, the American press was forced to question whether GM foods were safe. Up until then, the media had portrayed European resistance to America’s GM crops as unscientific anti-Americanism. But as the story of Arpad Pusztai reveals, the European anti-GMO sentiment had been fueled, in part, by far greater health risks than the scattered allergic reactions attributed to StarLink.

Between the Chapters: The Wisdom of Animals

Mice avoid eating GM foods when they have the chance, as do rats, cows, pigs, geese, elk, squirrels, and others. What do these animals know that we don’t? At the end of each chapter is a one-page story describing how farmers, students, and scientists discovered that animals refuse to eat the same GM foods that we consume everyday.

Excerpt:

The Washington Post reported that laboratory mice, usually happy to munch on tomatoes, turned their noses up at the genetically modified FlavrSavr tomato. Scientist Roger Salquist said of his tomato, “I gotta tell you, you can be Chef Boyardee and mice are still not going to like them.” [8] The mice were eventually force fed the tomato through gastric tubes and stomach washes. Several developed stomach lesions; seven of forty died within two weeks. The tomato was approved without further tests.

Chapter 2: What Could Go Wrong—A Partial List

Genetic engineers continually encounter unintended side effects—plants create toxins, react to weather differently, contain too much or too little nutrients, become diseased or malfunction and die. This chapter describes the process of genetic engineering and twenty-one ways in which it can create unexpected, potentially serious problems.

Excerpt:

New DNA chip technology has recently allowed scientists to monitor changes in DNA functioning when foreign genes are inserted. In one experiment, there was a staggering 5 percent disruption of gene expression. In other words, after a single foreign gene had been added through genetic engineering, one out of every 20 genes that were creating proteins either increased or decreased their output. According to Professor David Schubert, “while these types of unpredicted changes in gene expression are very real, they have not received much attention outside the community of the DNA chip users.” He adds that, “there is currently no way to predict the resultant changes in protein synthesis.” [9]

Chapter 3: Spilled Milk

“The scientists’ testimony before a Senate committee was like a scene from the conspiratorial television show The X-Files.” [10] This was how Canada’s leading paper described the story of six Canadian government scientists who tried to stand up to pressure to approve Monsanto’s genetically engineered bovine growth hormone (rbGH) which they believed was unsafe. The scientists were threatened by senior government officials, files were stolen from their locked file cabinets, Monsanto allegedly offered them a bribe of $1-2 million, and one senior official suddenly quit and disappeared, avoiding an appearance before a Parliamentary Committee. [11]

What was happening to the Canadian scientists in 1998 amounted to “re-runs” of what U.S. government scientists faced in the 1980s. When FDA scientists tried to blow the whistle on what was happening, they were stripped of responsibilities or fired. The FDA eventually approved rbGH on the basis of a research summary submitted by Monsanto that had distorted and deleted data about serious health effects, including cancer.

Excerpt:

The FDA’s article states, “it has also been determined that at least 90 percent of bovine growth hormone (bGH) activity is destroyed upon pasteurization of milk. Therefore, bGH residues do not present a human food safety concern.” [12] Robert Cohen decided to investigate this claim. He uncovered what he considers to be blatant scientific fraud. The research had been conducted by undergraduate Paul Groenewegan. His three co-authors all had close ties with Monsanto. The paper described how they heated milk at 162ºF for thirty minutes.

Cohen said, “when I read that, I said, wait a second, milk is pasteurized for 15 seconds at that temperature—not 30 minutes. They intentionally tried to destroy the hormone…. That must have been their mission. Why else would they heat the milk for 30 minutes at a high temperature reserved for a 15 second treatment?” But even after thirty minutes only 19 percent of the bGH in milk from hormone-treated cows was destroyed.

According to Cohen, “They then ‘spiked’ the milk. This is their word, ‘spike.’ They added artificial bGH … 146 times the level of naturally occurring bST in powdered form to the milk and heated it. The powdered bGH in milk was destroyed! They saved the day for Monsanto. The experiment worked. These men of science could claim that heat treatment destroys bGH.” [13]

Chapter 4: Deadly Epidemic

In 1989, first dozens, then thousands fell sick. About one hundred people died, others struggled with paralysis, unbearable pain, and debilitating symptoms. [14] Authorities eventually tracked its cause: contaminants produced in one company’s genetically modified variety of the food supplement L-tryptophan. [15] This chapter describes the evidence implicating genetic engineering as the cause of the epidemic and the efforts by industry and the FDA to divert the blame. Current regulations are so loose, they would allow that same type of deadly supplement onto the market today.

Chapter 5: 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.” [16] 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.

Excerpts:

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.” [17]

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.” [18] 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.” [19] 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.” [20]

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.” [21] 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.” [22] 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.” [23]

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.” [24]

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. [25] Their director wrote, “The possibility of unexpected, accidental changes in genetically engineered plants justifies a limited traditional toxicological study.” [26]

The Division of Food Chemistry and Technology outlined four potential dangers:

1. “Increased levels of known naturally occurring toxins”
2. “Appearance of new, not previously identified” toxins
3. Increased tendency to gather “toxic substances from the environment” such as “pesticides or heavy metals”
4. “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.” [27]

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.” [28]

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.” [29]

But even the draft of the policy that 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.” [30] 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.” [31] 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.” [32]

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 there is overwhelming consensus among scientists that GM foods are safe. In an Oct. 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.” [33]

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.” [34]

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.” [35] A January 2001 report from an expert panel of the Royal Society of Canada likewise supported the conclusions of the FDA scientists.

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