This has major relevance to the whole system of regulation of GM crops and foods - a system almost entirely built on the disclosure of information by the applicant, ie companies like Bayer.
As the FDA states it in its 'Statement of Policy: Foods Derived from New Plant Varieties':
'Ultimately, it is the food producer who is responsible for assuring safety.'
[GMO Policy, Federal Register, Vol. 57, No. 104 (1992), p. 22991]
And as the following article - by a professor of medicine at Harvard Medical School - notes, it is now known not only that Bayer has suppressed damaging evidence of possible adverse drug effects, but that it has also deliberately avoided acquiring such evidence in the first place:
'litigation uncovered a memorandum from a company executive arguing against performing a study of [a Bayer drug's] risk. "If the FDA asks for bad news, we have to give," read the memo, "but if we don't have it, we can't give it to them."'
The article concludes that, 'It is naive to expect companies to voluntarily fund studies that could sink lucrative products', while 'the FDA lacks the regulatory clout to require them'.
Or as a director of corporate communications at Monsanto once put it:
'Monsanto should not have to vouchsafe the safety of biotech food. Our interest is in selling as much of it as possible. Assuring its safety is the FDA’s job.'
[Phil Angell, quoted in the New York Times Magazine, October 25 1998]
It's worth remembering in this context that GM crop regulation, although involving a massively powerful novel technology, is far less stringent than that for pharmaceuticals, and relatively little testing is normally required by regulatory authorities.
In the case of the FDA, it asks, but does not require, companies to submit data only when GM crops contain gene products from plants that commonly cause allergies or contain genes that code for novel proteins. Anything else the company submits is also entirely voluntary.
With this kind of regulatory oversight, we're left almost entirely in the hands of companies like Bayer.
Dangerous Deception - Hiding the Evidence of Adverse Drug Effects
Jerry Avorn, M.D
New England Journal of Medicine 355;21 www.nejm.org
November 23 2006
[Dr. Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital in Boston].
On September 30 2006, a front-page article in the New York Times reported that the Food and Drug Administration (FDA) had issued a warning that the antifibrinolytic drug aprotinin, widely used to reduce perioperative bleeding in patients undergoing cardiac surgery, could cause renal failure, congestive heart failure, stroke, and death.
Some experts had been concerned about aprotinin (Trasylol) ever since its approval... one of two epidemiologic studies reported early this year provided support for this concern... The authors advised against further use of the drug, since safer, cheaper alternatives are available.
After the study was published, the FDA moved to convene an advisory committee to reassess the drug's safety and assembled the relevant data. The committee met on September 21...
What put aprotinin on the front page on September 30, however, was the revelation that its manufacturer, Bayer, had hired a private contract research organization to perform its own large observational study of postoperative complications in patients given the drug. The analysis... showed that patients who received aprotinin had higher mortality rates and substantially more renal damage than those given other treatments. But neither Bayer nor its contractor had provided the report to the FDA or even acknowledged its existence before the meeting.
Many aspects of the aprotinin saga are familiar to observers of the drug-evaluation process: a product is approved because it is more effective than placebo, worries emerge about its safety, few or no adequately powered controlled trials are conducted to address these issues, and payers spend huge sums on the drug, despite the dearth of evidence that it is better than older, cheaper agents...
It is naive to expect companies to voluntarily fund studies that could sink lucrative products, the FDA lacks the regulatory clout to require them...
Bayer has admitted that its suppression of the study was "a mistake," but this is not the first time the company has behaved in this manner. When Bayer was accused of hiding data unfavorable to its cholesterol-lowering drug cerivastatin (Baycol) before it was taken off the market in 2001, litigation uncovered a memorandum from a company executive arguing against performing a study of its risk. "If the FDA asks for bad news, we have to give," read the memo, "but if we don't have it, we can't give it to them."
Other companies have behaved similarly... The problem is not limited to observational studies. A few years ago, it was discovered that some companies had funded multiple clinical trials of their selective serotonin-reuptake inhibitor antidepressants but reported the results of only the favorable trials - distorting the evidence base physicians use in choosing drugs.
But the issue is thornier for epidemiologic analyses. Companies can conduct them secretly, even in-house, with the use of a purchased proprietary database, making the results even easier to conceal.