Thirty seven per cent of Americans over the age of 15 find sexual intercourse painful, difficult to perform or just plain unenjoyable. Who says so? Doctors Edward Laumann and Raymond Rosen, that’s who. And because they said it in the prestigious Journal of the American Medical Association, it popped up last week in every US newspaper.
Oh, did I forget to mention that the study’s authors recently worked for Pfizer, maker of Viagra? In the article JAMA did not mention it either. The not-tonight-honey study reflects a dangerous new problem: the threat to the impartiality of medical scientists evaluating the products of drugs companies for which they have worked.
Another example: calcium channel-blocking drugs reduce the risk of heart disease. Unfortunately, they can also give you a heart attack. Yet 70 learned articles in medical journals vouch for the drugs’ safety and efficacy.
According to an investigation by the New England Journal of Medicine, 96 per cent of the scientists who wrote articles supporting the drugs received financial benefits from the pharmaceuticals companies that make them. Only two out of 70 articles disclosed their authors’ financial interest.
Such financial interests raise concerns as to the objectivity of scientists responsible for granting government approval for drugs. One US manufacturer, Monsanto, is a case in point.
The Observer has received copies of letters, memoranda and meeting notes indicating that Monsanto was sent restricted documents from an international regulatory committee investigating the company’s controversial bovine growth hormone. BST boosts a cow’s milk output, but some European experts say BST has such yummy side-effects as increasing the amount of pus in milk, promoting infection in cow udders and potentially increasing risks of breast and prostate cancer in humans who drink the milk.
According to an internal Canadian health ministry memo of November 1997, Monsanto received advance copies of three volumes of position papers intended for review in closed meetings of the UN World Health Organisation’s joint experts committee on food additives. This is one valuable set of documents. The European Union’s ban on the genetically altered hormone expires this year. The experts committee advises the international commission, which will soon vote on whether to add BST to the Codex Alimentarius, the list of approved food additives. Codex listing would make it difficult for many nations to block imports of BST-boosted foods.
Monsanto’s cache included submissions by EC Directors-General for food and agriculture as well as analyses by British pharmacologist John Verrall. I spoke with Verrall just after he learned that his commentary had been passed to Monsanto. He was stunned, not just by the release of reports he believed confidential – participants sign non-disclosure statements – but by the source of the leak. The memo identifies Monsanto’s conduit from the UN committee as Dr Nick Weber of the US Food and Drug Administration.
Weber, it turns out, works at the FDA under the supervision of Dr Margaret Miller. Miller, before joining government, headed a Monsanto laboratory studying and promoting BST.
After seeing the committee’s documents, Monsanto faxed a warning to its allies in government that one participant on the expert committee, Dr Michael Hansen, was ‘not completely on board’.
Indeed he is not. Hansen is furious. A BST expert with the Consumers’ Policy Institute in Washington, Hansen regards the memos as putting in doubt the impartiality of the scientists in some US and Canadian authorities.
Other memos discuss plans by some US and Canadian officials to ‘share their communication strategy’ with industry, speak to members of the experts committee and obtain Monsanto’s comments ahead of the vote of the experts in February 1998 – in which Monsanto prevailed.
Because proceedings were confidential, we cannot know how a majority overcame objections of known dissenters. But we can presume Monsanto was not harmed by the late addition of BST defender Dr Len Ritter to the deliberations. An intra-office memo obtained from Canada’s Bureau of Veterinary Drugs states that Ritter’s name was suggested to the bureau’s director in an August 1997 telephone call from Dr David Kowalczyk, Monsanto’s regulatory affairs honcho.
Of course, obtaining government approvals to sell BST-laden milk is not much use to Monsanto if no one will buy the stuff. Luckily for Monsanto, the US FDA not only refuses to require labelling of hormone-laced products, but in 1994 published a rule that effectively barred dairies from printing ‘BST-free’ on milk products.
This strange milk-carton exception to America’s Bill of Rights was signed by Michael Taylor, deputy to the FDA commissioner. Prior to joining the US agency, Taylor practised law with the firm of King & Spalding, where he represented Monsanto. Taylor, no longer in government, did not return our calls to his office at his current employer, Monsanto Washington.
According to Canadian health ministry researcher Dr Margaret Haydon, Monsanto offered her bureau between US$1 million and $2m in a 1994 meeting. Monsanto counters that the funds were proffered solely to support the cash-strapped agency’s research.
Haydon and five other government scientists have filed an extraordinary plea with Canada’s industrial tribunal seeking protection for their jobs. They fear retaliation for exposing damaging facts about BST. America’s rush to approve the hormone in 1993 rested on a study published in the journal Science by FDA researchers that concluded there were no ‘significant changes’ in BST-fed rats.
The rats appear to tell a different tale. Their autopsies revealed thyroid cysts, prostate problems and signs of BST invading their blood. The US researchers failed to publish these facts and the FDA suppressed the full study.
The Canadian scientists, finally winning access to the full study, blew the whistle. The facts became public only weeks ago via their labour board action, a decade after the original.
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Gregory Palast’s column “Inside Corporate America” appears fortnightly in the Observer’s Business section. Nominated Business Writer of the Year (UK Press Association – 2000), Investigative Story of the Year (Industrial. Society – 1999), Financial Times David Thomas Prize (1998).