A Short History of Genetically Engineered Bovine Growth Hormone
by Jeffrey Smith
In 2004, the Tillamook County Creamery Association in Oregon, the nation's second largest producer of chunk cheese, told their members not to give recombinant bovine growth hormone (rbGH) to their cows to boost milk production. Soon after, Monsanto, which markets rbGH under the name Posilac, applied pressure on Tillamook's 147 farmers, trying to reverse the decision. The Association described Monsanto's actions as “an aggressive intrusion.” For those familiar with the history of this controversial drug, this is no surprise. Efforts to promote the genetically engineered growth hormone have been aggressive — or worse — starting with its evaluation by the Food and Drug Administration (FDA) in the late 1980's.
Veterinarian Richard Burroughs, who had a lead role in the review process, was shocked at how few tests the agency was requiring. Burroughs ordered more tests, but was soon fired. He said, “I was told that I was slowing down the approval process.” Burroughs says that the science in the studies was well outside the expertise of FDA employees, but officials “suppressed and manipulated data to cover up their own ignorance and incompetence.” Alexander Apostolou, director of the FDA's Division of Toxicology, says, “Sound scientific procedures for evaluating human food safety of veterinary drugs have been disregarded.” When he expressed his concerns at the agency, he was pressured to leave.” Chemist Joseph Settepani testified at a public hearing about “a systematic human food-safety breakdown at the Center for Veterinary Medicine.” Prior to his testimony, he was in charge of quality control for veterinary drug approvals. Soon after, he was stripped of his duties as a supervisor and sent to work in a trailer at an experimental farm. 
Retaliations against whistle-blowers did not go unnoticed. On March 16, 1994, others at the FDA resorted to writing an anonymous letter to members of Congress, saying they were “afraid to speak openly about the situation because of retribution from our director, Dr. Robert Livingston.” They wrote, “The basis of our concern is that Dr. Margaret Miller, Dr. Livingston's assistant and, from all indications, extremely 'close friend,' wrote the FDA's opinion on why milk from [rbGH]-treated cows should not be labeled. However, before coming to the FDA, Dr. Margaret Miller was working for the Monsanto company as a researcher on [rbGH].”
The hormone of greatest concern to critics and whistleblowers is not bovine growth hormone, however, but insulin-like growth factor 1 (IGF-1), which occurs naturally in both cows and humans. IGF-1 causes cells to divide and is one of the most powerful growth hormones in the body. Cows injected with rbGH have higher levels of IGF-1, and elevated levels of the hormone have been linked to cancer.
A Harvard study of 15,000 white males revealed that those with elevated IGF-1 levels in their blood were four times more likely to get prostate cancer than the average man. The report says, “administration of GH [natural human growth hormone] or IGF-1 over long periods...may increase risk of prostate cancer.” Similarly, premenopausal women younger than 50 who had high levels of IGF-1 were seven times as likely to develop breast cancer, according to a study in the Lancet. The authors wrote, “with the exception of a strong family history of breast cancer... the relation between IGF-1 and risk of breast cancer may be greater than that of other established breast-cancer risk factors.” The International Journal of Cancer also described a “significant association between circulating IGF-1 concentrations and an increased risk of lung, colon, prostate and pre-menopausal breast cancer,” and concluded, “Lowering plasma IGF-1 may thus represent an attractive strategy to be pursued.”
Monsanto researchers, however, have long assured the public that increased levels of IGF-1 isn't an issue with rbGH. In a letter published in the Lancetin 1994, they wrote, “IGF-1 concentration in milk...is unchanged,” and “there is no evidence that hormonal content of milk...is in any way different.” A month later, a letter in the same publication from a British researcher “reminded Monsanto that in its 1993 application to the British government for permission to sell rbGH in England, Monsanto itself reported that “the IGF-1 level went up substantially.” 
Even the FDA admits, “rbGH treatment produces an increase in the concentration of insulin-like growth factor-1 (IGF-1) in cow's milk.” While some supporters of rbGH acknowledge that “it at least doubles the amount of IGF-1 hormone in the milk,” the first study on the subject reported an increase of 360 percent. [12,13] Whatever the amount, IGF-1 in milk is not destroyed by pasteurization, nor is it destroyed in the stomach. Rather, it is absorbed intact, and could have a significant impact. A study that looked at data from more than a thousand nurses who carefully recorded their diet found that the food most associated with high IGF-1 levels was milk. The study's author said, “This association raises the possibility that diet could increase cancer risk by increasing levels of IGF-1 in the blood stream.” The milk used in the latter study was from cows not treated with rbGH. Milk from treated cows has higher levels of IGF-1 and might raise human IGF-1 levels even more.
Media Blacked Out
This potential link between rbGH and cancer was one of the many controversial topics to be covered in a four-part investigative news series on WTVT-TV, a Tampa-based Fox affiliate. Four days before it was to air, Fox received a threatening letter from Monsanto's attorney, causing the station to postpone the show. After a review from Fox's station manager the program was rescheduled for the following week. Monsanto's attorney then sent a second letter, this time threatening “dire consequences for Fox News.” The show was postponed indefinitely. Jane Akre and Steve Wilson, the award winning investigative reporters who had created the report for WTVT-TV, say that they were offered hush money to leave the station and never speak about the story again, which they declined. So Fox's corporate attorney led them in a series of rewrites, attempting to soften the language and apparently appease Monsanto.
The reporters were ultimately fired for refusing to report that the milk from treated cows was the same as normal milk. The reporters argued that Monsanto's own research showed a difference, such as the increased IGF-1 levels, and FDA scientists had acknowledged this. The reporters sued. Akre was awarded $425,000 by a jury that agreed that Fox “acted intentionally and deliberately to falsify or distort the plaintiffs' news reporting on BGH,” and that Akre's threat to blow the whistle was the reason she was fired.
This was not the first time pressure was applied to control media reports critical of rbGH. An earlier target was Dr. Samuel Epstein, Professor at the University of Illinois School of Public Health, who had cited numerous potential health dangers from rbGH, including risk of cancer. Monsanto's public relations firm created a group called the Dairy Coalition, which included university researchers whose work was funded by Monsanto and who selected “third party” experts and organizations. Representatives of the Dairy Coalition pressured news editors to limit coverage of Epstein. According to a February 1996 internal Dairy Coalition document, major news sources such as the Washington Post, The New York Times, the Wall Street Journal and the Associated Press didn't run stories on Epstein because the Coalition had successfully “educated” the reporters.
While Monsanto's tactics have been fairly effective in the United States, they have tried equally hard north of the border. In 1998, six Canadian government scientists testified that they were being pressured by superiors to approve rbGH. The six were employed by Health Canada — the Canadian equivalent of the US FDA. Their job was to determine if the milk from treated cows was safe to drink. They didn't think so. In fact, they had compiled a detailed critique of the FDA's evaluation of rbGH, showing that the US approval process was flawed and superficial. However, senior Canadian officials and Monsanto tried to force the Canadians to approve it anyway.
According to the Toronto Globe and Mail, “The scientists' testimony before a Senate committee was like a scene from the conspiratorial television show 'The X-Files.'” They told the senators that government scientists “often feel that their careers are threatened if they stand in the way of a drug they don't believe is safe,” and “managers without scientific experience regularly overrule their decisions.”
Dr. Margaret Haydon said that when she refused to approve rbGH due to her concerns for human health, she was taken off the study. The Ottawa Citizen reported that Haydon “recounted how notes and files critical of scientific data provided by Monsanto were stolen from a locked filing cabinet in her office,” and that she “told of being in a meeting when officials from Monsanto...made an offer of between $1 million and $2 million to the scientists from Health Canada — an offer that she told the senators could only have been interpreted as a bribe.”
In response, a Monsanto official went on Canadian national television saying that the scientists had misunderstood an offer for research money. This was not the first time Monsanto had been accused of offering bribes, however. In January 2005, Monsanto was fined $1.5 million by the US Department of Justice for offering bribes and questionable payments to more than 140 Indonesian officials between 1997 and 2002 in an attempt to gain approval for genetically modified cotton. According to the BBC, “A former senior manager at Monsanto directed an Indonesian consulting firm to give a $50,000 bribe to a high-level official in Indonesia's environment ministry in 2002. The manager told the company to disguise an invoice for the bribe as 'consulting fees.'”20
The Canadian scientists said that, after they testified, their superiors retaliated against them. They were passed over for promotions, given impossible tasks or no assignments at all, and one was suspended without pay. Three of the whistleblowers, who also spoke out on such controversial topics as mad cow disease, were ultimately fired on July 14, 2004.
Their efforts, however, did inspire Canada to join most industrialized nations in their ban of rbGH. Within the US, many school systems ban milk from treated cows and several dairies refuse to use it. Oakhurst Dairy of Portland, Maine, for example, requires its suppliers to sign a notarized affidavit every six months, stating their cows are rbGH-free. The Oakhurst label stated, “Our Farmers' Pledge: No Artificial Growth Hormones.” But on July 3, 2003, Monsanto sued the dairy over their labels. Oakhurst eventually settled with Monsanto, agreeing to include a sentence on their cartons saying that, according to the FDA, no significant difference has been shown between milk derived from rbGH-treated and non-rbGH-treated cows. This contradicts more recent statements by FDA scientists, but the sentence had been written years earlier by an FDA political appointee, Michael Taylor —Monsanto's former attorney.
Back to Tillamook
In February 2005, another attorney from Taylor's former firm arrived at the Tillamook County Creamery Association's offices with two Monsanto representatives. According to farmers, he drafted an amendment to the Association's bylaws that would reverse the ban on Posilac. During the ten days leading up to the vote on the amendment, Tillamook received letters, calls and e-mails from 8,500 consumers, urging them to stick with their ban. On Monday, February 28, by an 83-43 vote, Tillamook sided with these consumers.
That, of course, didn't stop the pressuring. One week later, Alex Avery of the Hudson Institute — a think tank which receives funds from Monsanto — wrote an entry on his Web page, “Milk is Milk,” that claimed, “Tillamook knows that there is a liability from both the economic harm this could cause their member dairies as well as a consumer liability if people buy their product because they've been misled to believe their product is somehow different based on their non-use of supplemental [rbGH].”
On March 25, the Oregonian published an op-ed piece by Alex Avery and Terry Witt. Witt's organization, Oregonians for Food and Shelter, has also been funded by Monsanto and has a Monsanto representative on its board. The op-ed is packed with false claims. For example, the authors say that rbGH is a “carbon copy of a cow's natural milk-production hormone.” In reality, the amino acid sequence of rbGH, created by genetically engineered E. coli bacteria, is not an exact replica of the cow's version.
Avery and Witt said that the drug “cuts costs,” but according to a study by USDA agricultural economists, using rbGH increases costs to the point where the extra milk production is not profitable for the average dairy.  Another study similarly found “there was no statistical difference in net income per cow . . . even if Monsanto provided [rbGH] free to the using farmers.”
Avery and Witt's op-ed insists that milk from treated cows is “indistinguishable” and according to FDA scientists, rbGH “doesn't change the milk one bit.” Not only are there hormonal differences already mentioned, milk from treated cows contains about 20 percent more pus due to the higher infection rates and increased amounts of antibiotics used to fight the infections.
Avery and Witt also make the remarkable statement, “Another baseless scare is that [rbGH] harms cows,” when even Posilac's label warns of “increases in cystic ovaries and disorders of the uterus...decreases in gestation length and birthweight of calves...increased twinning rates,” higher “incidence of retained placenta...an increased risk of clinical mastitis...periods of increased body temperature...an increase in digestive disorders such as indigestion and diarrhea” and “increased numbers of enlarged hocks and lesions (i.e. lacerations).”
Posilac's label also says that calves have “more disorders of the foot region,” but “studies did not indicate that use of [rbGH] increased lameness.” However, according to a Canadian panel of veterinarians who reviewed and then rejected the drug, rbGH does increase the risk of lameness. The panel further stated that problems from rbGH could be serious enough that farmers might have to destroy up to one fourth of their herd.
Charles Knight, whom Jane Akre and Steve Wilson interviewed for their report, was “one of many farmers who say they've watched [rbGH] burn their cows out sooner, shortening their lives by maybe two years.” Knight said “he had to replace 75 percent of his herd due to hoof problems and serious udder infections.” When he contacted Monsanto, Knight said that their representative told him “You're the only person having this problem so it must be what you're doing here, you must be having management problems.” Knight was not told that Monsanto had already found in its own research that “hundreds of other cows on other farms were also suffering hoof problems and mastitis.” Furthermore, the law required Monsanto to notify the FDA about any adverse reactions. But after four months of repeated phone calls by Knight and even a visit by Monsanto to his farm, the FDA had not been informed. Monsanto officials claim that “it took them four months to figure out that Knight was complaining about rbGH.”
Finally, Avery and Witt denigrated the Physicians for Social Responsibility (PSR) and their “activist” campaign against rbGH in Oregon. In a rebuttal printed in The Oregonian, two PSR representatives, Dr. Martin Donohoe and Rick North, said, “Our dictionary defines an activist as someone who takes 'positive, direct action to achieve an end'...Activists are more than just watchdogs. They have produced some of this nation's greatest accomplishments. Without them, 10-year-old children would still be working 12 hours a day in coal mines and sweatshops. Blacks would still be barred from schools, hotels and swimming pools. Women would still be denied the right to vote...When activism is attacked or neglected, democracy itself is in peril. Avery and Witt got one thing right — we are activists. And we're proud of it.”
Thanks to years of activists, whistleblowers, and investigators, more people are questioning the empty assurances by corporations and government the rbGH is safe. Alex Avery claims that “consumers rarely — if ever — mention production issues like [rbGH]-use as a factor influencing their purchasing decisions,” but actions speak louder than words. Organic farming, which doesn't allow genetically engineered inputs including rbGH, is the fastest growing agricultural sector, bounding ahead at more than 21 percent growth per year. This year, supermarkets like H-E-B and Whole Foods announced that they will label their own product lines as made without genetically modified ingredients. Tillamook cheese has joined the growing list of more than 160 rbGH-free national and regional brands that are responding to demands from informed consumers. As long as the media still provides venues for unsupported claims by rbGH proponents, there is work to be done. We must take a lesson from the activists in Oregon and share what we have learned.
Jeffrey M. Smith invites fellow activists to join the GM-Free School Campaign, which aims to remove genetically modified foods, including rbGH-milk, from kids' meals. Smith is the producer of the new video, Hidden Dangers in Kids' Meals: Genetically Engineered Food, author of the monthly syndicated column, “Spilling the Beans,” and director of the Institute for Responsible Technology. His best-selling book, Seeds of Deception: Exposing Industry and Government Lies about the Safety of the Genetically Engineered Foods You're Eating, is a critique GM foods. See www.seedsofdeception.com.
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