Musical Chairs, The Food and Drug Administration Subject to Influence

a. A Short History of the FDA

The Food and Drug Administration was officially created in 1930, but an equivalent agency had already been in existence since the beginning of the 20th century under the remit of the US Department of Agriculture (USDA). The agency was responsible for the approval of pharmaceutical or food products destined for human or animal consumption.

In 1938, President Franklin Delano Roosevelt signed the Food, Drug and Cosmetic Act that defines the agency’s terms of reference and is the source of its independence from the USDA. The agency was founded in the wake of a national drama which cost the lives of around a hundred people who had taken a medicine which contained a very toxic solvent. Hence the Food, Drug and Cosmetic Act, which stipulated that every product containing new substances had to be first tested by the manufacturer and then by the FDA prior to being allowed on the market.

In 1958, the text was supplemented by the “Delaney Amendment” which prohibited the approval of any product which could be carcinogenic. It’s important to understand that the agency did not carry out the toxicology studies itself: it was content to examine the scientific data supplied by the manufacturers. Its remit was wide and encompassed all pharmaceutical, veterinary, food and even cosmetic products….

b. Current links between Monsanto and the FDA

On 5 November 1993 the FDA gave its approval for Monsanto’s rBGH to go on sale under its brand name of Posilac, despite warnings from some of its scientific experts, like Dr Richard Burroughs, and even the recommendations of Congress. During the course of the 1980s and 90s the FDA changed its remit in order to support the growing biotech companies, including Monsanto, and to allow this new boom market to develop without any regulatory restrictions, just as the Reagan and Bush, the political leaders of the time, desired.

However, it should be understood that rBGH was the most controversial product ever authorised by the FDA, because it only ever had one, strictly economic purpose, which was to increase production, without providing any benefits either to the clients or to the animals. Given that there were several health concerns hanging over Posilac (pus in the milk, hormone and antibiotic residues), the FDA should have been much more rigorous in carrying out its responsibility to protect the consumer. But on the contrary, as we see from an internal document dating from 31 March 1993 [1], the FDA modified its regulations to introduce the concept of “manageable risk”. Even though under the provisions of the Food, Drug and Cosmetic Act, no product allowed on the market should pose a health risk to consumers, FDA officers changed the regulations to suit the demands of biotechnology. This was allowed to happen because of the closeness of some FDA officers to Monsanto, officers like Margaret Miller and Michael Taylor who were switching posts between the private sector, with Monsanto, and the public sector, at the FDA, according to the system known as “musical chairs” or “revolving doors”.

There is a pretty enormous network within the FDA charged with controlling the different stages of the decision-making process, running from the researchers to the management higher-ups, and of course the FDA directorate. So we find that one of the FDA researchers responsible for Posilac was Susan Sechen, a former student of and assistant to Professor Dale Bauman, who had been paid by Monsanto to test the GM hormone at Cornell University.

Dr Sechen’s boss was Margaret Miller, who worked for Monsanto from 1985 to 1989 as a researcher on rGBH, and who then left the St Louis firm to become the Deputy Director of the Office for New Animal Drug Evaluation at the FDA’s Centre for Veterinary Medicine (CVM), a key post concerned with the approval of the rBGH. Her boss was the Director, Dr R Livingston.2 These two managers were to take charge of the approval process for Posilac and to force agreement on rBGH while squeezing out dissident voices inside the agency, like Richard Burroughs. So we find that on the 16 March 1994, staff of the CVM expressed their concerns in an anonymous letter addressed to the FDA Ombudsman, and to the US Congress’s commission of enquiry, the General Accounting Office (GAO). In the letter we read of the following concerns: “We are afraid of speaking openly for fear of reprisal from the Director, Dr Robert Livingston, who is harassing anyone who expresses an opinion opposed to his own, to forestall whistleblowers. The cause of our anxiety is that Dr Livingston has had Dr Miller draft a regulation on the use of antibiotics in milk. This has fixed, in a completely arbitrary manner that has no basis in science, a permitted residue level of 1 ppm (part per million), in a completely arbitrary manner that has no basis in science, and without any preceding tests of the effect on consumer health. This level could be valid in relation to one antibiotic. But a cow can be treated with several antibiotics and each of them could be allowed up to 1ppm without any further testing. The effects of the different antibiotics could be cumulative, but that has not been taken into account”.

This letter sheds light on the kind of pressures brought to bear by the “friends of Monsanto”. For in fact this new arbitrary regulation provided the solution to one of the main problems raised by Posilac, the question of antibiotic residues in the milk. Remember that the US Congress’s investigative body, the GAO, had expressed concerns about the antibiotic residues and had required the FDA to carry out additional research. Not only did that remain undone but the FDA went even further and reviewed its regulations to allow higher levels of antibiotics in the milk.

Following these events, a new enquiry was begun by the GAO to establish whether there had been a “conflict of interests” involving Monsanto and three of its ex-employees, subsequently with the FDA, that’s to say Susan Sechen, Margaret Miller and Michael Taylor, the eminence grise of FDA lawyers…

Michael Taylor was one of the key players in Monsanto’s strategy and a living example of a career based on “revolving doors”. He was employed as a lawyer for the FDA from 1976 to 1980, then he rejoined the law firm of King and Spalding in Atlanta, which had Monsanto as one of its clients. Through the device of the law firm, he worked largely for Monsanto in the capacity of a legal consultant on regulatory issues in relation to labelling, a key issue in the approval of rGBH, as we shall see. On the 17 July 1991, he was appointed to the number two post at the FDA, in a new position that had been tailor-made for him: that of Deputy Commissioner, responsible for the agency’s policies. He stayed there three years, during which time he supervised the drawing up of the key texts concerning the regulations for rBGH, and subsequently, for GMOs. (For more information see the section on GMOs.) He left the FDA in 1994 and a few years later became Monsanto’s Vice President in charge of lobbying in Washington.

c. The ban on labelling of GMO products, a new FDA regulation to favour Monsanto

After being approved by the FDA, Posilac effectively started to be marketed by Monsanto on 4 February 1994. On 10 February 1994, the Federal Register published a new regulation, titled “Interim Guidance on the Voluntary Labeling of Milk and Milk Products From Cows That Have Not Been Treated With Recombinant Bovine Somatotropin”. Its stated objective was “to prevent false information or the introduction of error re the subject of rBST”. [2] Furthermore the FDA continued to support rBGH (or rBST) claiming that: “The agency has found that there is no significant difference between milk from treated and non treated cows”, and that was why it “has no authority to demand the labeling of milk coming from cows treated with rBST”. In the event, this meant that farmers were not obliged to tell their milk co-operatives or milk product distributors that Posilac had been used, which meant in practice that milk produced using rBGH would be mixed in with natural milk, without any special mention. But, going even further, this was accompanied by a ban on suppliers adding any “rBST free” labelling on their milk bottles. The argument set out by the FDA was a little surprising: “Because of the presence of natural BST in milk, no milk is “BST-free,’’ and a “BST-free’” labeling statement would be false.”

In addition, the FDA considered that the term “BST free|” “may imply that milk from untreated cows is safer or of higher quality than milk from treated cows. Such an implication would be false and misleading”. This worried milk producers who wanted to continue to produce hormone-free milk and who proposed a labelling project for a “milk without rBGH”, which was rejected by the FDA.

However, this directive had no legal force. The agency did not formally prohibit the “without rBST” label, but did strongly suggest that it should be accompanied by a phrase aimed at “informing the consumer” called a “contextual statement”: “No significant difference has been shown between milk derived form rBST-treated and non-rBST-treated cows.” This directive had been written by Margaret Miller and signed off for approval by Michael Taylor.

This information had been revealed by the “CVM whistleblowers” in their anonymous letter: “The basis of our concern is that Dr. Margaret Miller ..[ ]..wrote the FDA’s opinion on why milk from rBST-treated cows should not be labeled. However, before coming to FDA, Dr. Margaret Miller was working for the Monsanto company as a researcher on rBST. At the time when she wrote the FDA’s advice on labeling, she was continuing to publish articles together with Monsanto’s scientists on BST. It seems to us that this is a case of flagrant conflict of interests. As you know, if the milk is labeled as coming from cows treated with BST, consumers will not buy it and Monsanto will lose a great deal of money”. Some very pertinent observations, but which seem to have raised little comment.

This affair was thrown in the spotlight once more however when it was learned that Michael Taylor had been partially responsible for the content of the directive: we have only to take a close look at a confidential document of the 28 April 1993 from the firm of King and Spalding to the FDA. As we have noted before, Michael Taylor had acted for 7 years as an advisor to Monsanto on food labelling, especially in relation to food with contents of GM origin. The document sent by the law firm, headed “The labeling of milk and of food from milking cows treated with somatotropin would be illegal and ill advised ” had been “submitted at Monsanto’s request to the FDA”. This memorandum, with its threatening header, contained some of the same contentions put forward in the famous directive, notably re the absence of “significant differences” between milk with or without rBGH. It should be noted that this also links in with the treatment of GM products, as milk produced via rBGH also benefited from the “principal of substantial equivalence” which prohibits any distinction to be made between GM and traditional products. Substantial Equivalence

As a result of the directive, Monsanto was able to sue several milk manufacturers who refused to take milk from producers who were using bBGH and who labelled their products “rBGH free”. Despite strong demand from consumers for milk products free from the GM hormone, it’s still very hard to find foods that are guaranteed as produced without rBGH outside of products from organic agriculture.

[1] Information from Michael Hansen, of the Consumer Policy Institute, Le Monde Selon Monsanto, coedition La Decouverte,/Arte ed. 2008 [in my copy it’s p117]

[2] Federal Register, vol. 59, n° 28, 10 février 1994, p. 6279