- Dear Members,
Just hours after our initial report on a major resignation of a key FDA executive we learned that more executives are
now bailing under the heat of consumer complaint and whistleblower generated corruption investigations. Now two
leaders at the U.S. Food and Drug Administration (FDA) finding themselves in hot water at the agency.
The director of drug approval has been named in an ethics investigation and, as earlier reported, a head medical
device regulator has resigned.
As reported earlier today, the agency's director of the medical device division, Daniel Schultz, resigned yesterday
after 15 years with the group. Schultz was accused of siding with industry suppliers, against scientific
recommendations, during his five-year tenure leading the division, the Wall Street Journal reported today.
Schultz was involved in several controversial approvals, including a ReGen Biologics device used in knee surgery,
which, according the Journal, had been permitted despite years of opposition from reviewers and scientists.
Agency researchers reportedly described internal pressure to approve devices despite questionable safety or
efficacy.
"There are too many devices on the market that are not proven safe and not proven effective," Diana Zuckerman, of
the National Research Center for Women and Families in Washington, told Reuters.
Schultz said his departure "would be in the best interest of the center and the agency," an FDA memo said,
according to the Associated Press. FDA Commissioner Margaret Hamburg named Jeff Shuren, the associate
commissioner, as a temporary replacement.
Meanwhile, the FDA's head of drug evaluation is now under investigation by the Department of Health and Human
Services' inspector general for a conflict-of-interest allegation.
While leading the drug evaluation and research division, Janet Woodcock has collaborated with a senior scientist
from Momenta Pharmaceuticals, a company that is in competition with Amphastar Pharmaceuticals to gain
approval for a generic version of the $3.5 billion-a-year blood-thinning drug, Lovenox (enoxaparin) which is used to
prevent deep vein thrombosis (DVT) that can lead to blood clots in the lungs and is sold by Sanofi-Aventis SA, the
Journal reports.
Despite having filed for approval six years ago—two years ahead of competitor product Momenta, Amphastar's
generic version of the drug has not yet been approved.
Amphastar representatives claim that competitors at Momenta have had special access to Woodstock, who appointed one of Momenta's
founders, Ram Sasisekharan, to an FDA task force last year to investigate potentially contaminated heparin. Woodstock and
Sasisekharan went on to help author journal articles that reported the findings, notes the Journal, the publication of which raised Momenta's
stock 17 percent in just a day.
Although the two staffing snafus seem to be isolated, the FDA has been a target of massive criticism this year, including scrutiny from the
Obama Administration after a Salmonella outbreak and a late push to review older high-risk medical devices.
FDA corruption, and it’s backlash within the pharmaceutical industry, the industry we find more and more influential to the FDA decision
making process, is not just “capitalism” at its lowest – it has very severe consequences. Patients and consumers die or suffer severe
disabilities when drugs or devices are approved based on vested interests and cash filled envelopes and falsely written articles and false
or tainted studies as opposed to real, honestly conducted tests and clinical trials.
When next you complain to your government representative – let them know this. We are not picking at straws here. Crimes are being
committed and people had better start being held accountable for them.
Rudi
Managing Director
World Institute of Natural Health Sciences
www.winhs.org
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