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by Jim Edwards
March 12, 2010
from
BNet Website
Lawyers who want to sue drug companies
will be drooling over the news that the FDA has “certified” a 2009
letter sent anonymously by FDA staff to President Obama
describing,
“systemic corruption and wrongdoing
that permeates all levels of FDA.”
The FDA’s official recognition of
the letter means
1
that lawyers who want to use it to demonstrate that the FDA
isn’t perfect won’t have to go through weeks of tedious discovery
demands to find someone at the FDA who can officially say,
“Yup, we sent that.”
That’s going to be a headache for drug
companies who often defend their drugs in court by saying, “Hey, the
FDA said this product was fine and we did everything they asked - so
it’s not fair to hold us responsible.”
Plaintiffs’ lawyers can now hold up the letter in court and argue
that drug companies have been on notice that the FDA is riddled with
politics, conflicts of interest and outright corruption, and is, as
the letter says, “fundamentally broken.”
The letter made headlines when it was
sent last year to John Podesta
of Obama’s transition team. Written by a group of scientists
on FDA letter head - but with their names blacked out for fear
of retaliation - the letter describes a nightmare of bungling and
self-dealing among higher-ups at the drug safety agency.
It begs Obama to step in and reform the
shop:
…many other FDA managers who have
failed to protect the American public, who have violated laws,
rules, and regulations, who have suppressed or altered
scientific or technological findings and conclusions, who have
abused their power and authority, and who have engaged in
illegal retaliation against those who speak out, have not been
held accountable and remain in place.
The letter cites three dark chapters in
FDA history:
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Former chief Andrew von
Eschenbach’s interference with the approval of a knee
device.
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The approval of a breast cancer
detection device by director of the Office of Device
Evaluation Donna-Bea Tillman even though all FDA experts
voted against it, following a phone call from Connecticut
congressman Christopher Shays.
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And the approval by Daniel
Schultz of a medical device that prevents tissue scarring
against the unanimous opinion of his scientific staff.
According to
Doug Kreis, who sues drug
companies,
“Consumers have been given a slight
fighting chance now against [the] ‘FDA Defense,’ based on this
certification.”
Still unanswered: Who wrote the thing.
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