Five years ago, the FDA did not approve Ketek, an antibiotic with the generic name telithromycin, for use in the United States. In their decision, they cited toxic effects such as liver damage.
Arrests and Prison Terms
However, in response to the FDA's decision, the drug's manufacturer Sanofi-Aventis launched a new trial, study 3014, to test its safety. Study 3014 included fabricated data, and led to arrests and prison terms, forcing the FDA to throw out the results. The study is still defended as legitimate by Sanofi-Aventis.
Still Cited Today Despite this, the FDA reversed its original decision and approved Ketek, based on previous data collected and rejected by the FDA, along with smaller studies and the drug's European safety record. Study 3014 is still being cited by medical journals to back up Sanofi-Aventis' claim that Ketek is safe.
Reuters UK May 2, 2006
Dr. Mercola's Comment:You may recall a recent study I posted about Ketek, an antibiotic tested recently that treated some asthma symptoms, but worsened others. After reviewing the Reuters summary of this important Wall Street Journal piece (you can only review Wall Street Journal directly with a paid subscription), however, you'll be wondering why Ketek was ever approved for sale by the FDA at all.
Just one more reason to believe the FDA, in its current state, can't protect your health.
As currently configured, the FDA is more interested in protecting the interests of the drug industry than your health - it views the drug industry as its client, and the client is someone whose interests you represent.
Within the Center for Drug Evaluation and Research, about 80 percent of the resources are geared toward the approval of drugs, and 20 percent is for everything else. Drug safety is a measly 5 percent.
This speaks loads about their priorities. It is NOT about protecting you - it is about approving drugs as quickly as possible so the drug companies can reap their profits.
Congress has not only created that structure, but they have horribly worsened it with the Prescription Drug User Fee Act (PDUFA), by which drug companies actually pay money to the FDA so they will review and approve their drugs. This creates an absolutely massive conflict of interest and a fox-guarding-the-henhouse phenomena.
It is my passion to serve as a catalyst to change this fatally flawed system. But because I don't have $3 billion to invest in marketing like the drug companies, I can't do it without you!
You can have a major impact on improving the speed at which the migration away from the current dysfunctional health care system, to one truly based on prevention and real cure, occurs - by sharing the information in this newsletter with as many of your friends and relatives as possible.
As for Ketek, clearly it's yet another dangerous drug to avoid. And in fact, while I'm not opposed to all uses of antibiotics in general, I believe patients have been harmed far more often by them than they've been helped. In fact, it's been my experience antibiotics are used inappropriately well over 95 percent of the time.
So follow the Total Health Program and limit your need for potentially toxic and frequently inappropriately studied drugs.
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