FDA regulation meant to promote rBGH milk resulted in antibiotic resistance

E-mail posting at Biotech Activists list (biotech_activists@iatp.org) Posted: 05/05/2000

By Robert Cohen


(rBGH milk is milk produced by cows treated with injections of genetically engineered = recombinant Bovine Growth Hormone (rBGH) also called rBST)



This week's New England Journal of Medicine (April 27, 2000, Vol. 342, No. 17) is more proof of biotechnology's failure.

I have written about this story many times, but publication in a peer-reviewed journal now confirms what I have been saying for many years. This message bears repeating.

In 1989, Monsanto was aware that cows in test herds treated with the genetically engineered bovine growth hormone developed sores and lesions on their udders that were collectively called mastitis. Milk from rbST-treated cows contained increased levels of pus, blood, and virulent bacteria.

In order to deal with the problem, Monsanto's top dairy scientist, Margaret Miller, left the firm and became FDA's Monsanto "plant." Once at FDA, Dr. Miller arbitrarily changed the existing antibiotic standard. She increased by 100 times the allowable level of antibiotics that farmers could put into milk.

The consequences of her action were that new strains of bacteria developed in dairy cows that were immune to existing antibiotics, which no longer worked when they were needed. People drank milk containing increased amounts of antibiotics and new species of bacteria with immunities to those antimicrobials.

The latest issue of the New England Journal of Medicine contains a study by Paul Fey, et al, confirming the emergence of a new strain of salmonella that was isolated from a 12-year-old boy who was admitted into a hospital with fever, abdominal pain, and diarrhea.

That salmonella strain is resistant to a new wonder drug, Ceftriaxone, which has also been used on dairy cows. We wonder why few scientists have previously noted why wonder drugs are no longer so wonderful.

Sophisticated methods of plasmid analysis were performed on the bacteria obtained from the child and from the cattle, and they were found to be indistinguishable. In addition to the resistance to Ceftriaxone, the bacteria had developed resistance to thirteen other antibiotics.

The study raises extreme health concerns, and provides evidence that disease is directly related to antibiotic-resistant strains of salmonella that have resulted from overdosed farm animals. Such errors do not develop in the natural scheme of things. This error is a direct result of Monsanto's genetically engineered bovine growth hormone.

How much more evidence must FDA and Congress examine before government regulators once again show concern for the health and safety of the American people?

Robert Cohen


Comment by PSRAST

Since more than ten 10 years, scientists have been increasingly concerned about the more and more rapid increase of strains resistant to antibiotics caused by use of antibiotic preparations.

Leading experts have emphasized that powerful measures are required to reduce the use of antibiotics. There are clear evidence linking antibiotics resistance in salmonella and other bacteria to the use of antibiotics in farm animals. In a situation, feared to cause the resurgence of intractable lethal infectious diseases, an FDA official, Margret Miller, has acted so as to further increase the risk of the emergence of dangerous bacteria all over the USA by allowing a considerable increase of antibiotics use on cows. The only obvious reason for such a decision appears to have been to promote the use of rBGH. This is further supported by the following background data (taken from the Ecologist, see http://www.psrast.org/ecologmons.htm):


"Even FDA insiders have criticized the agency for its slack review of the drug, but the FDA has dismissed these concerns and fired at least one official who blew the whistle on the organisation's corrupt drug approval process. Veterinarian Dr. Richard Burroughs reviewed animal drug applications at the FDA's Center for Veterinary Sciences from 1979 until he was fired in 1989. In 1985, Burroughs headed the FDA's review of t rBGH and remained directly involved in the review process for almost five years. Burroughs wrote the original protocols for animal safety studies and reviewed the data that rBGH developers, including Monsanto, submitted as they carried out safety studies.

A 1991 article in Eating Well magazine quotes Burroughs describing a change in the FDA beginning in the mid-1980s. "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." This is the atmosphere in which the FDA carried out its review of rBGH. According to Burroughs, the FDA was totally unprepared to review rBGH, the first bioengineered animal drug to go through the FDA's approval process; rBGH was out of the scope of most FDA employees' knowledge. But rather than admit incompetence, the FDA "decided to cover up inappropriate studies and decisions," and agency officials "suppressed and manipulated data to cover up their own ignorance and incompetence?

Burroughs himself was faced with corporate representatives who wanted the agency to ease strict safety testing protocols, and he saw corporations drop sick cows from rBGH test trials and manipulate data in other ways to make health and safety problems disappear. According to Burroughs, the raw, untouched data stashed away behind the agency's doors and protected as trade secrets would show otherwise.

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 testimony to state legislatures, and to the press. Inside the FDA, he rejected a number of corporate-sponsored safety studies as insufficient and was prevented by his superiors from investigating data submitted by industry revealing possible health problems caused by rBGH. Though Burroughs had a record at the FDA showing eight straight years of good performance, he began receiving poor performance reports, for which he claims he was set up. Finally, in November 1989, he was fired for "incompetence"

Not only did the FDA fail to act upon evidence that rBGH was not safe, the agency actually promoted the Monsanto corporation's product before and after the drug's approval. In doing so, the FDA took on the impossible double role of regulator and promoter of bioengineered foods. Dr. Michael Hansen of Consumers Union notes 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.

This dual role also manifested itself in other ways. In an apparent attempt to quell public controversy over rBGH, for example, two FDA researchers published industry and "independent" data in the journal Science in 1990 to show that rBGH was safe for consumers)' Gerald Guest, the director for FDA's Center for Veterinary Medicine told Science, "We'd like to get our side of the story out, to show why we're comfortable with the safety. We'd like for people to know that ifs a thoughtful process. and we want it to be open and credible

Guest was apparently doing a lot of wishful thinking. Professor Samuel Epstein criticized the FDA for acting "as a booster or advocate for an animal drug that hasn't yet been approved." Epstein and others faulted the FDA for including only pieces of unpublished studies about rBGH in the Science article, but not making the full studies available for independent review.

The FDA's pro-rBGH activities make more sense in light of conflicts of interest between the FDA and the Monsanto corporation." Michael R. Taylor, the FDA's deputy commissioner for policy, wrote the FDA's rBGH labelling guidelines. The guidelines, announced in February 1994, virtually prohibited dairy corporations from making any real distinction between products produced with and without rBGH." To keep rBGH-milk from being "stigmatized" in the marketplace, the FDA announced that labels on non-rBGH products must state that there is no difference between rBGH and the naturally occurring hormone. In March 1994,

Taylor was publicly exposed as a former lawyer for the Monsanto corporation for seven years. While working for Monsanto, Taylor had prepared a memo for the company as to whether or not it would be constitutional for states to erect labelling laws concerning rBGH dairy products. In other words. Taylor helped Monsanto figure out whether or not the corporation could sue states or companies that wanted to tell the public that their products were free of Monsanto's drug.

Taylor wasn't the only FDA official involved in rBGI-1 policy who had worked for Monsanto. Margaret Miller, deputy director of the FDA's Office of New Animal Drugs was a former Monsanto research scientist who had worked on Monsanto's rBGH safety studies up until 1989. Suzanne Sechen was a primary reviewer for rBGH in the Office of New Animal Drugs between 1988 and 1990. Before coming to the FDA. she had done research for several Monsanto-funded rBGH studies as a graduate student at Cornell University. Her professor was one of Monsanto's university consultants and a known rBGH promoter."


This evidence of a failure of FDA to fulfill its duty to guard public health is in the same vein as its development of the lenient regulations making it possible to approve improperly tested GE foods. FDA did so in spite of warnings from its own experts as has recently been discovered in a lawsuit, see "FDA records support the lawsuit challenging its policy".

It is the regulations created by FDA that paved the way for the world-wide avalanche of GE foods.

Jaan Suurkula M.D.


"Genetically Engineered Food - Safety Problems"
Published by PSRAST

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