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FDA PBS progrqam. What is behind CODEX. (Archive.)

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FDA PBS progrqam. What is behind CODEX. (Archive.)

Posted by Walt Stoll on November 17, 2003 at 05:56:33:

ps- remember to cut and paste a url to your address box if it is too
long for it to link properly...
Misty L. Trepke

What do Pondimin, Redux,Seldane, Posicor, Duracht, Hismanal, Raxar,
Rezulin, Propulsid, Lotronex, Raplon, and Baycol all have in common?

Answer: All are drugs that the FDA pulled off the market within the
last few years that were fraudulently approved by this criminal
Agency where corruption runs rampant.

I just watched a great documentary on the Public Broadcasting
System's "Frontline" program titled "Dangerous Prescription" about
how the FDA is killing Americans in unprecedented numbers in the
past 5 years due to criminality within the Agency.

Congressional Pharma Stooges such as Senator Dick Durbin (S.722
Dietary Supplement Safety Act) and Congressmen Davis, Waxman, and
Dingle (HR 3377) have a lot of nerve claiming that dietary
supplements pose a threat in our society and that we need "FDA to
reign them in" when we have this heavily documented level of
corruption at the FDA which is clearly serving as a Trade
Association for the pharmaceutical industry.

Call your Congressman today via 202-225-3121 and complain. Tell them
to tune in this PBS documentary on the web on Sunday.

On Sunday, people world wide can view this show in its entirety on
at the URL above, and I encourage all of you on the IAHF list to,
and to encourage your elected officials to also- because instead of
engaging in witch hunts attacking safe dietary supplements, the
criminals who work for the world's FDA's need to be reigned in. Some
should be imprisoned for approving poisons such as these.

Former FDA drug reviewers who quit due to total disgust at how their
reports were censored, and altered, and how they were pressured to
change reports to make them more favorable for approval were
interviewed regarding the fraudulent approval of such dangerous
drugs as Dexfenfluoramine, Pondamin, Raxar and many others.

Here is an interactive Chart showing a dozen drugs that were
fraudulently approved by the FDA, then removed from the market
between 1997 and 2001. The chart names the drug, the manufacturer,
when there were approved, what the drug was prescribed for, the
adverse effects, and the date the drug was finally withdrawn from
the market.

Here is information from the PBS website about this interesting

How good is America's drug safety system? Since 1997, more than a
dozen prescription drugs have been taken off the market due to
serious side effects -- in some cases after hundreds of injuries and
even deaths have occurred. Is the Food and Drug Administration,
which is responsible for approving and monitoring the safety of the
medications we take, up to the task? Here are excerpts from
FRONTLINE's interviews with the FDA's Steven Galson and Paul
Seligman, Public Citizen's Sidney Wolfe, and Raymond Woosley
of the University of Arizona.

Is the FDA too close to the industry it regulates? Critics argue that
industry funding of the drug review and approval process gives
pharmaceutical companies, and their lobbyists, too much influence
over decision-making and policy. To address these issues, in
excerpts from FRONTLINE's interviews, are Public Citizen's Sidney
Wolfe, the FDA's Steven Galson, the University of Arizona's Raymond
Woosley, and pharmaceutical industry lobbyist John Kelly.

"The FDA is wholly dependent on trust -- on trusting [that] the
company is providing all the truth all the time," says Leo Lutwak, a
retired FDA drug reviewer specializing in obesity. Dr. Lutwak was
the chief medical reviewer for weight-loss drugs and was at the
center of the Fen Phen controversy. In this interview, Dr. Lutwak
recalls the role he played in the review of Redux and provides
insight into the sequence of events that led to the recall of
this drug. (Since the time this interview was conducted, Lutwak has
been retained by plaintiff's counsel in the ongoing litigation
surrounding these drugs.)


"I think it was pretty well understood," say former FDA scientist
Michael Elashoff, "that if you were advocating turning a drug down --
particularly if it was from a large pharmaceutical company -- that
that wouldn't be good for your career." A drug reviewer for the FDA
from 1995 to 2000, Elashoff says he was marginalized within the
agency after he voiced his concerns about a new flu drug called
Relenza. Here, Elashoff speaks out about the culture of the FDA's
drug approval process.


"We think we can run a high-quality independent program, regardless
of the source of the resources," says the FDA's Steven Galson,
acting director of the Center for Drug Evaluation and Research, "as
long as, of course, the resources aren't linked to performance goals
that are going to interfere with our independence." In this
interview, Galson discusses the FDA's drug safety system and
explains how the Prescription Drug User Fee Act helps the FDA.

"The fundamental point," says Seligman, director of the FDA's Office
of Drug Safety, "is that no drug -- even having gone through this
long period of development, testing, and review -- is 100 percent
safe." Seligman explains how his office handles adverse-event
reports from pharmaceutical companies and through the MedWatch
system, and discusses various areas in which the agency's drug
safety program could be improved.

International Advocates for Health Freedom
POB 10632 Blacksburg VA 24062 USA;
800-333-2553 N.America
540-961-0476 World

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