FDA and Monsanto Milk the Public

explanation, raised the FDA standard by 100 times for the permissible level of antibiotics that farmers could put into milk. She single..:handedly cleared the way for a booming business for Monsanto's rBGH hormone. A cozy club was emerging between private biotech companies and the government agencies that should be regulating them. It was a club more than a little fraught with potential conflict of interest. I I

As one of its top officials, Taylor helped the FDA draw up guidelines to decide whether GMO foods should be labeled. His decision was not to label GMO foods.

At the same time, again under Taylor's guiding hand, the FDA ruled that risk-assessment data, such as data on birth defects in cattle or even possible symptoms in humans arising from consumption of GMO foods, could be withheld from the public as "confidential business information:'

Were it to leak out that Monsanto, Dow or other biotech companies were creating grotesque deformities in animals fed GMO foods, it might be detrimental for the stock price of the company, and that would damage the full flowering of private enterprise.

This, at least, seemed the logic behind the perverse kind of "Shareholder value ueber Alles:' As FDA Biotechnology Coordinator James Maryansky remarked, "The FDA would not require things to be on the label just because a consumer might want to know them."12

A lawyer for Monsanto, Michael Taylor, had been placed in charge of GMO food policy within the government's principal food safety body. As a suitable postscript, honoring the adage, "we take care of our friends;' Monsanto rewarded the diligent public servant by appointing Michael Taylor to be Vice President of Monsanto for Public Policy after he left the FDA. 13

FDA and Monsanto Milk the Public By 1994, after a suitable amount of time had elapsed, the FDA approved the sale of rBGH milk to the public. Under the FDA rules, of course, it was unlabeled, so the consumer could avoid undue anxiety about giving himself or his children exposure to cancerous

agents or other surprises. He would never know. When Monsanto's Posilac caused leukemia and tumors in rats, the US Pure Food and Drug Act was rewritten to allow a product that caused cancer in laboratory animals to be marketed for human consumption without a warning label. It was as simple as that.

Though Monsanto claimed that its rBGH was one of the most thoroughly examined drugs in US history, rBGH was never tested in the long-term for (chronic) human health effects. A generally accepted principle in science holds that two years of testing is the minimal time for long-term health studies. rBGH was tested for only 90 days on 30 rats. The short-term rat study was submitted by Monanto to the FDA but was never published. The FDA refused to allow anyone outside the administration to review the raw data from this study, saying that publication would "irreparably harm" Monsanto. Monsanto has continued to refuse to allow open scientific peer review of the 90 day study. This linchpin study of cancer and BGH has never been subjected to scrutiny by the scientific community. 14

Not content to feed GMO milk exclusively to its own unwary population, the US Government exerted strong pressure on Mexico and Canada also to approve rBGH, as part of an effort to expand Monsanto's rBGH market globally.

However, the FDA-Monsanto campaign got a nasty setback in January 1999, when the Canadian counterpart to the FDA, Health Canada, broke ranks with the US and issued a formal "notice of non-compliance" disapproving future Canadian sales of rBGH, sometimes also called rBST or recombinant Bovine Somatotropin.

The action followed strong pressure from the Canadian Veterinary Medical Association and the Royal College of Physicians, which presented evidence of the adverse effects of rBGH milk, including evidence of lameness and reproductive problems. Monsanto had been very eager to break into the Canadian market with its rBGH, even to the p'oint, according to a Canadian CBC television report, that a Monsanto official tried to bribe a Canadian health official sitting on the Government review committee with an offer of$I-2 million, to secure rBGH approval in Canada without

further studies. The insulted official reportedly asked, "Is that a bribe?" and the meeting ended. IS

Moreover, a special European Commission independent committee of recognized experts concluded that rBGH, as reported in Canadian findings, not only posed the above-named dangers, but also major risks especially of breast and prostate cancer in humans.

In August 1999, the United Nations Food Safety Agency, the Codex Alimentarius Commissi<?n, ,ruled unanimously in favor of a 1993 European Union moratorium on the introduction of Monsanto's rBGH milk. Monsanto's rBGH was thus banned from the EU.16

This setback was not to daunt the persistent bureaucrats at the FDA, or their friends at Monsanto. Since GMO labeling had been forbidden by the FDA, Americans were blissfully unaware of the dangers of drinking the milk they were encouraged to consume for better health. "Nature's most perfect food" was the dairy industry's slogan for milk. With regard to reporting the UN decision and the negative Canadian conclusions, the US media were respectfully quiet. Americans were simply told that the EU was trying to hurt American cattle farmers by refusing imports of hormone-fed US beef.

One concerned FDA scientist who refused to sit by idly was FDA Veterinarian Dr. Richard Burroughs, who was responsible, from 1979 until 1989, for reviewing animal drugs such as rBGH. From 1985 until the year he was fired, Burroughs headed the FDA's review of Monsanto's rBGH, thus being directly involved in the evaluation process for almost five years. Burroughs wrote the original protocols for animal safety studies and reviewed the data submitted by rBGH developers from their own safety studies.

In a 1991 article in Eating Well magazine, Burroughs described a change in the FDA beginning in the mid-1980s. Burroughs was faced with corporate represeritatives who wanted the FDA to ease strict safety testing protocols. He reported seeing corporations dropping off sick cows from rBGH test trials and then manipulating data in such ways as to make health and safety problems "disappear."17

Burroughs challenged the agency's lenience and its changing role from guardian of public health to protector of corporate profits. He criticized the FDA and its handling of rBGH in statements to Congressional investigators, in testimonies to state legislatures, and in declarations to the press. Within the FDA, he rejected a number of corporate-sponsored safety studies, calling them insufficient. Finally, in November 1989, he was fired for "incompetence."

The FDA failed to act on the evidence that rBGH was not safe. In fact, the agency promoted the Monsanto Corporation's product before and after the drug's approval. Dr. Michael Hansen of Consumers Union noted that the FDA acted as an rBGH advocate by issuing news releases promoting rBGH, making public statements praising the drug, and writing promotional pieces about rBGH in the agency's publication, FDA Consumer.ls

In April 1998, two enterprising award-winning television journalists at Fox TV, an influential US network owned by Rupert Murdoch, put together the remarkable story of the rBGH scandal including its serious health effects. Upon pressure by Monsanto, Fox killed the story and fired Jane Akre and her husband Steve. In an August 2000 Florida state court trial, the two won a jury award of $425,000 damages and the Court found that Fox "acted intentionally and deliberately to falsify or distort the plaintiffs' news reporting on rBGH."19

With their ample financial resources, Fox Television and Monsanto took the case to a higher court on appeal and got the decision reversed on a legal technicality. The FDA kept silent. Monsanto continued to market rBGH milk unabated. As one former US Department of Agriculture official stated, the guiding regulatory percent for genetically modified foods was, "don't tell, don't ask:' which meant, "If the industry does not tell government what it knows about its GMOs, the government does not ask:'20 That was little reassurance for the health and safety concerns of the population. Few ever realized it however, as on the surface it appeared that the FDA and other relevant agencies were guarding their health interests in the new area of GMO foods.