Yesterday, the FDA lost its third ranking official since September, Dr. David Orloff, a division director who oversaw the review of drugs for endocrine and metabolic disorders.
Orloff's name won't ring a bell with you, but I'm sure one of the last FDA drug reviews he supervised will. The advisory committee under his jurisdiction called for the approval of muraglitazar (Pargulva), a drug that triggered a heart attack or stroke in 35 patients.
After the Journal of the American Medical Association study appeared in print and more wrangling, mega-drugmaker Bristol-Myers eventually concluded muraglitazar would require many more years of research before it could be approved.
Not surprisingly, one of my heroes, Dr. David Graham, recently pointed to muraglitazar as one of the new crop of drugs that could put the lives of Americans at risk.
New York Times December 7, 2005 Registration Required
The Lakeland (Fla.) Ledger December 7, 2005