The following is the second part of a series called Get Our Milk Off Drugs, written in response to pending legislation that would interfere with dairies who want to label their products as free from genetically engineered bovine growth hormone (rbGH or rbST). Although the bill was passed in the Kansas legislature, it would effect the labeling of every product sold in the state, including all national brands. Therefore, we ask everyone to email Governor Sebelius before April 16, urging her to veto the bill. Furthermore, since Governor Sebelius is expected to become the new Secretary of Health and Human Services, the email asks her to use her new appointment to ban this dangerous drug once and for all.
FDA Promotes Unsafe Milk Due to Industry Pressure
By Jeffrey M. Smith
Get Our Milk off Drugs, Part 2
(See part 1 for the link between bovine growth hormone (rbGH) and cancer.)
“The whole rbGH thing represents fundamental flaws in the regulatory process. . . . It was bad science and bad regulation.”
This was the conclusion of former FDA veterinarian Richard Burroughs, who was a lead reviewer in the approval process of recombinant bovine growth hormone (rbGH) for nearly five years. The drug “was approved prematurely without adequate information,” says Burroughs, whose life and career became a casualty in a perfect storm of industry manipulation and political collusion.
As the only member of the FDA team who had dairy herd experience, Burroughs wrote the original protocols for evaluating the safety of rbGH on cows. The FDA didn’t conduct the tests themselves. It was always the drug’s maker who performed the studies and reported the results. But according to Burroughs, they “would come in and try to negotiate the protocols to water them down.” And when they ultimately presented their findings, Burroughs was shocked to discover, “They just went out and skewed the data.”
The drug’s maker Monsanto, for example, claimed that only a handful of cows developed udder infections, but documents later revealed the actual number to be 9,500. Furthermore, infected cows were often dropped from company studies altogether. And in tests designed to show that rbGH injections did not interfere with fertility, leaked FDA documents showed how researchers added cows to the study that were pregnant prior to injection.
According to Burroughs, even FDA officials “suppressed and manipulated data to cover up their own ignorance and incompetence.” He said that since the science behind the rbGH studies was well outside the expertise of agency employees, rather than admit they were in over their heads, “the Center decided to cover up inappropriate studies and decisions.”
One of the problems they faced was that Monsanto flooded them with huge amounts of irrelevant information, making it hard for them to properly analyze what was important. “We were overwhelmed by the magnitude of the research,” says Burroughs. At one point, the Human Safety Division reviewed forty volumes of submissions in just two weeks.
Burroughs refused to accept compromises on safety and demanded more tests. But in late 1989, he was fired and some of his tests canceled. He says, “I was told that I was slowing down the approval process,”
At a trial that later reinstated him at the FDA, his former boss admitted that Burroughs had been set up. When he rejoined the agency, officials never let him see any rbGH data again and made his life miserable. He soon quit.
Rigging the numbers
Although some FDA scientists vehemently defended rbGH, their claims don’t hold up. They said, for example, that bovine growth hormone does not increase substantially in milk from treated cows. The study they cited, however, shows a 26% increase of the hormone. Furthermore, the cows used for that study had received a substitute rbGH formulation, at only 2% of the normal injected dosage.
The FDA scientists claimed that 90% of the bovine growth hormone in the milk was destroyed during pasteurization, so it wouldn’t matter even if there had been a substantial increase. But they failed to mention that the researchers pasteurized the milk 120 times longer than normal, and even then only destroyed 19% of the hormone. So they spiked the milk with powdered hormone—146 times the naturally occurring levels—heated that mixture 120 times longer than normal, and under those artificial conditions were able to destroy 90% of the hormone.
Canadian Government Scientists Say FDA Evaluation was a Façade
Years after the drug was on the market, Canadian government scientists analyzed the FDA’s approval process and wrote a lengthy and scathing report. It recounted omissions, contradictions, weaknesses, and gaps in the FDA’s approval process. Known as the Gaps Analysis Report, it concluded that the FDA’s “1990 evaluation was largely a theoretical review taking the manufacturer’s conclusions at face value. No details of the studies nor a critical analysis of the quality of the data was provided.”
According to the report, since rbGH was a hormone, “its chemistry should have prompted more exhaustive and longer toxicological studies in laboratory animals.” These are “usually required . . . to ascertain human safety.” Because they weren’t conducted, “such possibilities and potential as sterility, infertility, birth defects, cancer and immunological derangements were not addressed.”
Studies normally used to determine whether a drug is carcinogenic will test two different species for about two years—the lifetime of mice or rats. But Monsanto tested rbGH on rats for 28 or 90 days. FDA official John Scheid later admitted to the Associated Press that the agency had never actually examined the raw data from Monsanto’s rat feeding study; rather they based their conclusions on a summary provided by Monsanto. According to Rachel’s Environment and Health Weekly, “relying on a summary of a study, rather than on detailed data from the study, would violate FDA’s published procedures.”
The Gaps report showed that the FDA “improperly reported” data from the feeding study, arriving at false and unsupported conclusions of safety. When the Canadians pointed out that 20 to 30 percent of the rats fed rbGH developed antibody responses, the FDA was forced to admit that they had accidentally overlooked the antibody study entirely. Furthermore, the Canadian report showed that some male rats which were fed the hormone developed cysts on their thyroid and changes in their prostate gland, which should have prompted further investigation.
The Canadian report also pointed out that injected cows suffer from “numerous adverse effects” and that the milk and meat from sick cows may make us sick. Hormone-treated cows can develop birth defects, reproductive disorders, udder infection, foot and leg injuries, metabolic disorders, uterine infections, indigestion, bloat, diarrhea, lesions, and shortened lives. Cows on the drug for only eight months had much larger hearts, livers, kidneys, ovaries, and adrenal glands. The Canadians wrote that although the significant changes in the health of cows “may have had an impact on human health,” this was not taken into consideration by the FDA when they approved the drug.
Monsanto Hijacks Regulators
Bovine growth hormone was the first genetically engineered animal drug reviewed by the FDA, and there was a lot of pressure to get it approved quickly. Both the first Bush and Clinton White Houses had ordered the agency to promote biotechnology and the agency was apparently doing whatever it took to follow orders.
Disgruntled FDA employees wrote an anonymous letter to Congressmen, claiming that the whole rbGH evaluation process was embroiled in fraud and conflict of interest. For example, they complained of the role of Dr. Margaret Miller.
“[Miller] wrote the FDA’s opinion on why milk from [rbGH]-treated cows should not be labeled. However, before coming to FDA, Dr. Margaret Miller was working for the Monsanto company as a researcher on [rbGH]. At the time she wrote the FDA opinion on labeling, she was still publishing papers with Monsanto scientists on [rbGH]. It appears to us that this is a direct conflict of interest to have in any way Dr. Miller working on [rbGH].”
On April 15, 1994, three Congressmen responded to the letter’s allegations by asking the U.S. General Accounting Office (GAO) to investigate. The congressmen wrote, “The entire FDA review of rbGH seemingly has been characterized by misinformation and questionable actions on the part of both FDA and the Monsanto Company officials.” The letter also describes the previous attempt by the GAO to investigate the rbGH approval process, which they “had to abandon . . . because of the Monsanto Company’s refusal to make available to them all pertinent clinical and related data.” The letter directed the GAO to look into potential conflicts of interest not only for Margaret Miller, but also for Michael Taylor and Susan Sechen.
Sechen formerly conducted Monsanto-sponsored research on rbGH, and then joined the FDA to become the lead reviewer for the drug. Taylor used to be Monsanto’s outside attorney, working with them, according to the Congressmen’s letter, “regarding food labeling and regulatory issues.” The FDA created a new position for Taylor, as Deputy Commissioner for Policy. He was in charge of overseeing the formation of the agency’s policy on rbGH, which ultimately allowed rbGH on the market without adequate testing, and without mandatory labeling.
Taylor even wrote a paper expressing an opinion that if a dairy was to label its milk as rbGH-free, it should also include a bold disclaimer stating, “The FDA has determined that no significant difference has been shown between milk derived from rbGH-supplemented and non-rbGH-supplemented cows.” This was a suggestion, not a requirement. But the Kansas legislature passed a law on April 3, 2009 making it a requirement for products sold in the state—including all national dairy brands. (Ask Governor Sebelius to veto that bill.)
Taylor also oversaw the FDA’s dangerous hands-off policy on genetically modified foods, which also benefited Monsanto at the expense of public health. He eventually left the FDA for the USDA, where he worked on GMO issues. Taylor then took the position of vice president for Monsanto. He now works closely with the Obama administration on food safety.
Milk Controversy Spills into Canada
In 1998, six Canadian government scientists, including those who wrote the Gaps Analysis Report, testified before the Senate that they were being pressured by superiors to approve rbGH, even though they were convinced it was unsafe. They also testified that documents were stolen from a locked file cabinet in a government office, and that Monsanto offered them a bribe of $1-2 million to approve the drug without further tests. (A Monsanto representative told national Canadian television that the scientists had obviously misunderstood an offer for research money. US court documents later revealed that at the same time Canadian officials accused them of attempted bribery, Monsanto was actively offering bribes to about 140 government officials in Indonesia, trying to gain approval for their genetically modified seeds.)
In words reminiscent of Burroughs’ experience at the FDA years earlier, the Canadian scientists told the Senate committee, “pharmaceutical manufacturers have far too much influence in the drug approval process.” 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.”
One of the whistle-blowing scientists to testify, Shiv Chopra, revealed that the policy in the department is to “serve the client.” The client, however, is no longer defined as the public: “The client is now the industry.”
“We have been pressured and coerced to pass drugs of questionable safety, including [rbGH],” Chopra said. He “testified that one of his managers threatened to ship him and his colleagues to other departments where they would ‘never be heard of again’ if they didn’t hurry favorable evaluations of rbGH.”
Soon after testifying, Chopra was suspended by his department for five days without pay. The cause, he later told another Senate committee, was retaliation for his testimony.
In spite of blatant efforts within the government to approve rbGH, Canada ultimately banned it. Nonetheless, the health of Canadians is still impacted, as much of their imported milk is from drugged cows US.
The time for banning rbGH in the US is long overdue. Ask Governor Sebelius, who plans to be our next Secretary of Health and Human Services, to do so as her first act.