To: IAHF List
Subject: PBS Documentary Indicts FDA: Exposes Rampant Criminality
Date: 14 Nov 2003 06:49:30 -0000
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. http://www.pbs.org/wgbh/pages/frontline/shows/prescription/hazard/
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when there were approved, what the drug was prescribed for, the adverse effects, and the date the drug was finally withdrawn from the market.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 program:
SAFE AND EFFECTIVE?
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.
HOW INDEPENDENT IS THE FDA?
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.
INTERVIEW: LEO LUTWAK, MD
"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.)
INTERVIEW: MICHAEL ELASHOFF, PhD.
"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.
INTERVIEW: STEVEN GALSON, MD
"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.
INTERVIEW: PAUL SELIGMAN, MD, MPH
"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.
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