Ketek: Why Did the FDA Approve This Deadly Antibiotic?

You may recall a study I posted about Ketek (generic name telithromycin), an antibiotic tested recently to treat some asthma symptoms, but worsening others. After reviewing this must-read piece in yesterday's Wall Street Journal (free link below), however, you'll be wondering why Ketek was ever approved for sale by the FDA at all.

Five years ago, the FDA did the right thing -- citing toxic side effects like liver damage -- by not approving Ketek stateside (although it was in Europe). That is, not until after multi-national drugmaker Sanofi-Aventis launched a new trial, study 3014, to test its safety. To say the least, study 3014 was a glowing example of how not to conduct a drug trial, rife with fabricated data -- for a variety of incredible reasons -- still defended to this day by the aforementioned drugmaker.

Yet, despite all these shenanigans -- leading to arrests and prison terms -- that forced the FDA to throw out the tainted results, the agency approved Ketek anyway, based on previous data collected and rejected by the FDA, along with smaller studies and the drug's European safety record. What's more, study 3014 is still being cited by medical journals today to back up Sanofi-Aventis' claim Ketek is safe.

Just one more reason to believe, the FDA, in its current state, can't protect your health.

Wall Street Journal May 1, 2006 Subscription Required

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