GM Watch
  • Main Menu
    • Home
    • News
      • Latest News
      • Newsletter subscription
      • Daily Digest
      • News Reviews
      • News Languages
    • Articles
      • GM Myth Makers
      • GM Reports
      • GM Quotes
      • GM Myths
      • Non-GM successes
      • GM Firms
        • Monsanto: a history
        • Monsanto: resources
        • Bayer: a history
        • Bayer: resources
    • Videos
      • Latest Videos
      • Must see videos
      • Cornell videos
      • Agriculture videos
      • Labeling videos
      • Animals videos
      • Corporations videos
      • Corporate takeover videos
      • Contamination videos
      • Latin America videos
      • India videos
      • Asia videos
      • Food safety videos
      • Songs videos
      • Protests videos
      • Biofuel myths videos
      • Index of GM crops and foods
      • Index of speakers
      • Health Effects
    • Contact
    • About
    • Links
    • Donations
    • How donations will help us
News and comment on genetically modified foods and their associated pesticides    
  • News
    • Latest News
    • Newsletter subscription
    • News Reviews
    • News Languages
      • Notícias em Português
      • Nieuws in het Nederlands
      • Nachrichten in Deutsch
    • Archive
      • 2021 articles
      • 2020 articles
      • 2019 articles
      • 2018 articles
      • 2017 articles
      • 2016 articles
      • 2015 articles
      • 2014 articles
      • 2013 articles
      • 2012 articles
      • 2011 articles
      • 2010 articles
      • 2009 articles
      • 2008 articles
      • 2007 articles
      • 2006 articles
      • 2005 articles
      • 2004 articles
      • 2003 articles
      • 2002 articles
      • 2001 articles
      • 2000 articles
  • Articles
    • GM Myth Makers
    • GM Reports
    • How donations will help us
    • GM Quotes
    • GM Myths
    • Non-GM successes
    • GM Firms
      • Monsanto: a history
      • Monsanto: resources
      • Bayer: a history
      • Bayer: resources
  • Videos
    • Index of speakers
    • Glyphosate Videos
    • Latest Videos
    • Must see videos
    • Health Effects
    • Cornell videos
    • Agriculture videos
    • Labeling videos
    • Animals videos
    • Corporations videos
    • Corporate takeover videos
    • Contamination videos
    • Latin America videos
    • India videos
    • Asia videos
    • Food safety videos
    • Songs videos
    • Protests videos
    • Biofuel myths videos
    • Index of GM crops and foods
  • Contact
  • About
  • Links
  • Donations
  • 2021
  • 2021a
SUBSCRIBE TO REVIEWS

GMWatch Facebook cornfield banner

SCIENCE SUPPORTS REGULATION OF GENE EDITING

Plant tissue cultures

GENE EDITING: UNEXPECTED OUTCOMES AND RISKS

Damaged DNA on fire

GENE-EDITED CROPS & FOODS

Help stop the new threat

News Menu

  • Latest News
  • News Reviews
  • Archive
  • Languages

Please support GMWatch

Donations

You can donate via Paypal or credit/debit card.

Some of you have opted to give a regular donation. This is greatly appreciated as it helps place us on a more stable financial basis. Thank you for your support!

2006 articles

Bayer's Dangerous Deception - Hiding the Evidence

  • Print
  • Email
Details
Published: 01 December 2006
Created: 01 December 2006
Last Updated: 22 October 2012
Twitter
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.
---

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.

  • Prev
  • Next

Menu

Home

News

News Archive

News Reviews

Videos

Articles

GM Myth Makers

GM Reports

GM Myths

GM Quotes

How Donations Will Help Us

Contacts

Contact Us

About

Facebook

Twitter

RSS

Content 1999 - 2021 GMWatch.
Web Development By SCS Web Design