Health Supreme by Sepp Hasslberger

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

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

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September 21, 2005

FDA Drug Approval Standards Challenged

Categories

The FDA, in evaluating new drugs for approval, does not require that these drugs be any better than existing drugs, even if their costs are several times higher than those of currently available medicines. Typically, trials compare the new drug against a placebo. Keep in mind that placebos are specifically formulated for each trial by the same company that does the drug trial and that the composition of a placebo is neither standard nor is it usually disclosed. (See: Prescribing a placebo)

Incredibly, the FDA neither performs a formal risk-benefit analysis on drugs it approves. Is it any wonder that medicines have become a major cause of death in the western world? The New England Journal of Medicine, in a recent article, challenges the wisdom of such lax approval standards.

My proposal: Let's start by comparing drugs not with placebo but with the best known previous treatment - be it another drug, be it specific nutritional support, or a herbal or other intervention. We might actually learn something about the real efficacy or lack of it of new drugs that way. And let's also evaluate the side effects against the actual increase in efficacy over previous treatments. Now that would be an idea!

FDA Standards - Good Enough for Government Work?

 


posted by Sepp Hasslberger on Wednesday September 21 2005
updated on Tuesday September 27 2005

URL of this article:
http://www.newmediaexplorer.org/sepp/2005/09/21/fda_drug_approval_standards_challenged.htm

 


Related Articles

Prescribing a placebo
Placebos are one of the "holy cows" of pharmaceutical investigation. Drug trials have to be "double-blind placebo controlled" to be of any scientific value. The placebo, formerly called a "sugar pill" is the standard (the null point) against which to measure the effect of a drug. That makes perfect sense, wouldn't you agree? Hundreds of millions of dollars are spent on trials that test the efficacy of new drugs and... [read more]
July 25, 2003 - Sepp Hasslberger

Medical system is leading cause of death and injury in US
Shocking statistical evidence is cited by Gary Null PhD, Caroly Dean MD ND, Martin Feldman MD, Debora Rasio MD and Dorothy Smith PhD in their recent paper Death by Medicine - October 2003, released by the Nutrition Institute of America. "A definitive review and close reading of medical peer-review journals, and government health statistics shows that American medicine frequently causes more harm than good. The number of people having in-hospital,... [read more]
October 29, 2003 - Sepp Hasslberger

FDA Waffles Over Antidepressants Causing Suicides
According to an article in the New York Times, officials of the FDA are now acknowledging that antidepressants do cause children and teenagers to become suicidal, but the FDA is not taking the steps it should - ban the drugs for use in children, as the UK has already done. The major preoccupation seems to be that if antidepressants are removed or carry strong warnings, there is nothing left to... [read more]
September 15, 2004 - 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

FDA Suppressed Vital Drug Safety Information
12 June 2005 - The Independent published an article today which makes the case that vital safety information on numerous pharmaceutical products is purposely withheld by the FDA to protect the interests of pharma producers. In addition to Vioxx and the whole family of Cox-2 inhibitors, other painkillers, previously thought safe, are now found to cause similar effects on cardiac health. The data was buried and partially concealed by the... [read more]
June 12, 2005 - Sepp Hasslberger

 

   
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