Things are heating up. The Canadian Senate's examination of rBGH led to a
focus on the Canadian "Gaps Report". This is a heretofore confidential
analysis of Monsanto's confidential rBGH data by Canadian scientists at the
HPB's Bureau of Veterinary Medicines describing the unanswered safety
questions surrounding rBGH. These regulatory scientists were being
harrassed and pressured to downplay these dangers and, in contravention to
the Canadian Food and Drugs Act, recommend approval of rBGH.
The report made its way to the internet via the National Farmers Union
website. Then US food safety activists picked up on it and started asking
why US regulatory scientists didn't let these factors stop them from
approving rBGH in the US. Turns out key studies were not completely
reviewed in the US approval process. No kidding. Whether or not there was
pressure to approve this key money maker for Monsanto is not acknowledged,
only that the full 90-day rat study, central to Canadian scientists safety
cocerns, was not reviewed in full, only in summary form. The summary
obscured the safety issues, which were uncovered in the full data set.(
This demonsrtates why the pressure for short approval times is /can be a
safety hazard )
Conflict of interest in the approval process was mind-boggling. One FDA
reviewer was a former Monsanto scientist who had worked for Monsanto on
rBGH studies, then moved to FDA and was apparently allowed to work on the
rBGH file. This is unheard of in my experience and cannot be accidental.
FDA has rules about about COI (Witness the COI in the generics scandal of
1989 that sent one FDA chief and several staff to jail).
As the note below says, the US activists are demanding FDA reversal of rBGH
approval and/or heading to the courts.
The heat's on now. This rBST scandal may expose much of the global industry
influence system used to approve drugs. rBGH is also the icon for a hot
international trade debate over the use of genetically engineered foods and
drugs (US for; EU against; Canada as one unofficial tie breaker).
International expert groups like 'JECFA' and Codex are now being seen as
stacked by industry and lacking independence.
An international, muti-billion dollar meltdown is at hand.
The above was written in response to the following:
>Here is some information on a very significant event. A press conference
>this Tuesday in Washington DC, about the hazards of BGH, and announcing a
>lawsuit against FDA if they do not take BGH off the market.
>Several hundred of the media are expected at the press conference.
>Also, I have been told that a few hours after the press conference, it
>will be telecast at their website. http://www.ems.org
>MEDIA ADVISORY FOR:
>CONTACT: Tom Lalley, Lisa Magnino
>Tuesday, December 15, 1998
>Environmental Media Services (202) 463-6670
> 100th EMS Press Breakfast: Tuesday, December 15, 1998, 9:00
>FIRED TV REPORTERS TO DESCRIBE THEIR BATTLE TO AIR SERIES ON BOVINE GROWTH
>Lawsuit charges Fox pressured reporters to broadcast false information
>When Steve Wilson and Jane Akre - award winning reporters at Fox-owned WTVT
>in Tampa, Florida - sought to air their series on bovine growth hormone
>(BGH) last year, Monsanto warned Fox executives that "dire consequences"
>would result if the stories ran as originally written. Fox rewrote the
>stories over 70 times and eventually fired the reporters. The series never
>Now Wilson and Akre - who recently received the National Society of
>Professional Journalists Award for Ethics - are suing Fox asserting the
>network broke the law when it fired them for refusing to broadcast
>inaccurate reports. Steve Wilson and Jane Akre will join health and legal
>experts to discuss their suit and the possible dangers of BGH at the 100th
>EMS Press Breakfast, Tuesday December 15, 1998 in the Crystal Room of the
>Monsanto describes BGH as "a dairy management tool" which safely boosts
>milk production in 30 percent of US cows. The U.S. Food and Drug
>Administration approved BGH in 1993 but failed to consider important
>information that recently became public after a review by FDA's Canadian
>counterpart, Health Canada. Monsanto's own studies link BGH to cysts in
>rats. The BGH derived substance believed to have caused the growths has
>been linked to cancer in humans according to research at Harvard Medical
>Also at the breakfast, the Center for Food Safety will unveil a legal
>action asking the FDA to suspend approval of BGH immediately. If the FDA
>does not take BGH off the market it will face a lawsuit.
>WHO: Steve Wilson - Investigative Reporter
>Jane Akre - Investigative Reporter
>Michael K. Hansen, Ph.D. - Senior Researcher, Consumers Union
>John Stauber - Executive Director, PR Watch
>Andrew Kimbrell - Executive Director, Center for Food Safety
>WHEN: Tuesday, December 15, 1998, 9:00 am
>WHERE: The Willard Hotel - In the Crystal Room on the ground floor
>1401 Pennsylvania Avenue, NW
>- A continental breakfast will be served -
>Tom Lalley, Program Director
>Environmental Media Services
>1320 18th Street NW, Suite 500
>Washington, D.C. 20036
>Richard Wolfson, PhD
>Consumer Right to Know Campaign,
>for Mandatory Labelling and Long-term
>Testing of all Genetically Engineered Foods,
>500 Wilbrod Street
>Ottawa, ON Canada K1N 6N2
>tel. 613-565-8517 fax. 613-565-1596
>Our website, http://www.natural-law.ca/genetic/geindex.html
>contains more information on genetic engineering as well as
>previous genetic engineering news items
>Subscription fee to genetic engineering news is $35 for 12 months
>See website for details.
Dr. E. Ann Clark
University of Guelph
Guelph, ON N1G 2W1
Phone: 519-824-4120 Ext. 2508
FAX: 519 763-8933