Health Supreme by Sepp Hasslberger

Networking For A Better Future - News and perspectives you may not find in the media

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November 15, 2003

FDA Misses Risky Business

The FDA is charged with controlling the safety and efficacy of drugs before marketing, but judging from available statistics, pharmaceutical drugs have become more of a problem than a help in achieving good health.

John Hammell, president of the International Advocates For Health Freedom contends the FDA is not able to independently evaluate possible dangers of new pharmaceuticals to be approved. Researchers of the agency are often pressured into changing their reports to hide dangers and make approval possible.

This seems to show a widespread pattern behind the incredible corruption that has been documented about the approval of the popular but poisonous sweetener Aspartame, which the FDA allowed on the market despite the recommendations of its own experts not to do so.

Read John's description as recently published in Tim Bolen's newsletter, of a recent documentary on the Public Broadcasting System's "Frontline" program titled "Dangerous Prescription".

Is the FDA Really Protecting Us? Nope...

Guest Editorial: Opinion by IAHF President John Hammell

November 15th, 2003

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 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. International Advocates for Health Freedom POB 10632 Blacksburg VA 24062 USA

John Hammell
http://www.iahf.com
800-333-2553 N.America
540-961-0476 World

This "Millions of Health Freedom Fighters - Newsletter" is about the battle between "Health and Medicine" on Planet Earth. Tim Bolen is an op/ed writer with extensive knowledge of the activities of a subversive organization calling itself the "quackbusters," and that organization's attempts to suppress, and discredit, any, and all health modalities that compete with the allopathic (MD) paradigm for consumer health dollars. The focus of the newsletter is on the ongoing activities, battles, politics, and the victories won by members of the "Health Freedom Movement" against the "quackbusters" It details "who the quackbusters are, what they are, where they are operating, when they appear, and how they operate - and how easy it is to beat them..."

For background information on the "Battle between Health and Medicine" go to: www.savedrclark.net. A copy of THIS newsletter, and older ones, are viewable at the website www.quackpotwatch.org.

For EVEN MORE interesting and related articles go to www.bolenreport.com.


See also related:

The Role of the FDA
The Claim There is "No Scientific Evidence" for Alternative Treatments...

 


posted by Sepp Hasslberger on Saturday November 15 2003
updated on Monday July 3 2006

URL of this article:
http://www.communicationagents.com/sepp/2003/11/15/fda_misses_risky_business.htm

 


Related Articles

The FDA and the drug companies are getting awfully cozy...
With virtually no public debate, Congress has passed a law that dramatically increases the FDA's dependence on large drug companies for its funding. It's an expansion of a law passed in 1992 intended to speed up the approval process for new AIDS medications. But this time the emergency was of a different sort. The FDA was running out of money to keep its new employees. Going before Congress and asking... [read more]
June 10, 2003 - Sepp Hasslberger

In the FDA we trust?
..."Last Daily Dose, I spilled a story that many in the medical mainstream (and the drug companies they're slaves to) would no doubt love to keep under wraps: A possible link between antidepressant drugs and suicide in depressed juveniles. But the ironic part of the story was that the red flag on this potential link is being hoisted not by a marquis medical journal, some big-name investigative reporter, or even... [read more]
January 03, 2004 - Chris Gupta

Vioxx Shows: FDA Unable To Protect Public From Deadly Medical Drugs
According to recent congressional testimony, "the FDA as currently configured is incapable of protecting America against another Vioxx. We are virtually defenceless," said David Graham, associate director of the agency's Office of Drug Safety. The quote is from an article published in South Africa, titled Doctor: FDA is too cosy with drug firms. The FDA is the national food and medicines regulatory agency of the US but it has been... [read more]
November 23, 2004 - Sepp Hasslberger

The Dirty Little Secret between the FDA and Drug Industry
$1.2 billion to buy the FDA? What you say never - well read the following. This is yet again proof that the governments work for the industry under the pretense of looking after our interests. Most new drugs are produced with expediency at the expense of safety and efficacy. Frequently they are not as effective as the older one's that they may be replacing... Secrecy & Conflict of Interest Why... [read more]
August 26, 2004 - Chris Gupta

Codex: FDA 'Vetoes' Optimal Nutrition For Health
Just a month ago today, at the Codex Alimentarius Food Labelling Committee meeting in Ottawa, Canada, the US delegate Dr Barbara Schneeman said that no reference should be made to "optimizing nutrition and health" in guidelines that would encourage "adequate information" on food labels. A Codex Committee meeting - Image by Sepp The Committee was discussing how the World Health Organization's Global Strategy on Diet, Physical Activity and Health should... [read more]
June 04, 2006 - Sepp Hasslberger

FDA Sued Over GM Food Labels - But US Consumers Strangely Unconcerned
According to a recent article by Julian Watson of UPI, the Center for Food Safety has filed a lawsuit against the FDA to require labeling and pre-market testing of GM-derived - genetically modified - foods. What seems quite normal in European countries - a demand for thorough examination of the science used to justify genetic modification of foods and insistence on being told when a food has been so modified... [read more]
June 16, 2006 - Sepp Hasslberger

 

 

 


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