GMW: Bayer's Dangerous Deception - Hiding the Evidence

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GMW: Bayer's Dangerous Deception - Hiding the Evidence

" GM WATCH " <info

Fri, 1 Dec 2006 11:38:53 GMT

 

 

 

 

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Here are some extracts from a piece in the New England Journal of

Medicine that describes Bayer's suppression of information that its drugs

were not as safe as it claimed.

 

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.

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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].

 

EXTRACTS ONLY

 

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.

 

 

 

 

 

 

 

 

 

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