9/25/2000 – FDA – “Safety For Sale” – USA Today

More evidence of the FDA’s “dirty laundry” was exposed in today’s USA Today
this morning. Although nothing new, it is marvelous to see the mainstream
press exposing it once again.

Let’s hope that soon something will be done to address this serious public
health risk – the “safety assurances for sale” policies of the FDA. Generally
all that is done is something to assure the public that “all is well” and
there is nothing to fear as they did in the FDA hearings on Prozac and
suicide in 1991. One month after I returned to Utah after that FDA hearing
that assured us of the safety of Prozac, a mother, in my own neighborhood,
butchered and bludgeoned her three children with a hammer and sheep sheering
knife before stabbing herself to death in a cold turkey attempt to get off
Prozac and several other meds her doc (also on Prozac) had put her on. She as
so many could find no one who would wean her off the drugs that she continued
to complain were “turning her brain to mush”.

Do I believe that the blood of those innocent children and their mother is on
the hands of the FDA? You bet I do! I had just witnessed my friend Suzanne
Johnson of Atlanta, GA stand before the FDA and tell them how Prozac had
induced a rare blood disorder that was slowly taking her life and that her
blood was on their hands. (She died the following year.) She also said that
the blood of many others would be on their hands if they did not take a firm
stand in warning the public of the dangers of this drug. They refused and
thousands, upon thousands more have had their lives destroyed as a result.
Five on the panel who voted that day had financial ties to the pharmaceutical
companies, but they were allowed to sign a wavier stating that they would not
allow their money to sway them. Obviously they think we were all born
yesterday.

This practice of buying safety assurances from the FDA MUST end. Hopefully
the we, the ICFDA, can help that to happen. The FDA has not protected the
public for years. That is extremely well documented in Morton Mintz’s
wonderful book A THERAPUTIC NIGTHMARE (1969).

Dr. Ann Blake Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org
_______________________

http://www.usatoday.com/news/washdc/ncssun06.htm

09/25/00- Updated 12:24 AM ET

FDA advisers tied to industry

By Dennis Cauchon, USA TODAY

More than half of the experts hired to advise the government on the safety
and effectiveness of medicine have financial relationships with the
pharmaceutical companies that will be helped or hurt by their decisions, a
USA TODAY study found.

These experts are hired to advise the Food and Drug Administration on which
medicines should be approved for sale, what the warning labels should say and
how studies of drugs should be designed.

Number of drug experts available is limited

The experts are supposed to be independent, but USA TODAY found that 54% of
the time, they have a direct financial interest in the drug or topic they are
asked to evaluate. These conflicts include helping a pharmaceutical company
develop a medicine, then serving on an FDA advisory committee that judges the
drug.

The conflicts typically include stock ownership, consulting fees or research
grants.

Federal law generally prohibits the FDA from using experts with financial
conflicts of interest, but the FDA has waived the restriction more than 800
times since 1998.

These pharmaceutical experts, about 300 on 18 advisory committees, make
decisions that affect the health of millions of Americans and billions of
dollars in drugs sales. With few exceptions, the FDA follows the committees’
advice.

The FDA reveals when financial conflicts exist, but it has kept details
secret since 1992, so it is not possible to determine the amount of money or
the drug company involved.

A USA TODAY analysis of financial conflicts at 159 FDA advisory committee
meetings from Jan. 1, 1998, through last June 30 found:

At 92% of the meetings, at least one member had a financial conflict of
interest.

At 55% of meetings, half or more of the FDA advisers had conflicts of
interest.

Conflicts were most frequent at the 57 meetings when broader issues were
discussed: 92% of members had conflicts.

At the 102 meetings dealing with the fate of a specific drug, 33% of the
experts had a financial conflict.

“The best experts for the FDA are often the best experts to consult with
industry,” says FDA senior associate commissioner Linda Suydam, who is in
charge of waiving conflict-of-interest restrictions.

But Larry Sasich of Public Citizen , an advocacy group, says, “The industry
has more influence on the process than people realize.”

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