The new drug application for the antibiotic, Ketek, marketed by Sanofi-Aventis, was rejected twice, in 2001 and 2003, before FDA management approved the drug on April 1, 2004, based on fraudulent studies, and over the objections of the FDA's own scientists.
Many patients have been harmed because doctors trusted the FDA's approval of Ketek. According to a review of the FDA's Adverse Event Reporting System, by the staff of the Senate Finance Committee, between July 2005 and September 2005 alone, there were two deaths, 35 liver adverse reactions, 44 cardiac events, and 80 visual events in Ketek patients.
In addition, internal FDA emails obtained by staffers, prove that top FDA officials were aware of the problems with Ketek before it was approved, and that FDA scientists, Dr David Ross, Dr David Graham, Dr Charles Cooper, and Dr Rosemary Johann-Liang, all warned FDA management about the serious adverse effects associated with the drug.
A May 16, 2006, FDA memo authored by safety reviewers said Ketek was linked to 12 reported liver failures including 4 deaths, 23 reports of serious liver injury, and a higher rate of adverse reaction reports than other antibiotics on the market, and the reviewers recommended a black box warning for the Ketek-related liver injury.
However, Sanofi-Aventis and FDA officials disregarded the recommendation and announced that only a new bolded warning would be added.
In addition to the massive Vioxx litigation, Merck is facing a large number of plaintiffs in lawsuits over the osteoporosis drug Fosamax, alleging the drug causes jaw-bone death, which is an extremely rare condition.
Kenneth Hargreaves of the University of Texas, discussed the increasing cases of ONJ in the April 3, 2006 LA Times. "We've uncovered about 1,000 patients in the past six to nine months alone," he said, "so the magnitude of the problem is just starting to be recognized."
Oral surgeon, Dr Salvatore Ruggiero, one of the first doctors to notice the increase in 2001, told the Times, "Even though the chances of getting this are small, considering there are 23 million women taking this drug, we could be talking about a significant number of people."
The FDA approved Fosamax in 1995, and because it is a relatively new drug, unreported cases OJN may be higher than expected because doctors may attribute the pain caused by the condition to osteoporosis, according to Diane Wysowski of the FDA's Office of Drug Safety in the Times.
Here again, the FDA and the drug maker were aware of the link between OJN and Fosamax but failed to warn the public until after the drug was prescribed to tens of millions of patients.
The man most credited for the creation of the preemption policy is the FDA's former Chief Counsel, Daniel Troy, who plays for the opposite team in private practice. Prior to his appointment as Chief Counsel, Mr Troy was a partner at Washington's Wiley Rein & Fielding, where he filed lawsuits against the FDA on behalf of the pharmaceutical industry to loosen restrictions on off-label prescribing and advertising of prescription drugs.
In fact, critics say, it was Mr Troy's loyalty to the industry, demonstrated by years of legal battles against FDA regulations, that earned him the appointment by the Bush administration as the industry's inside legal counsel.
Mr Troy himself bragged about his part in implementing the preemption policy in an article he wrote in the October 9, 2006, Legal Times stating: "I was also at the FDA while January's Physician Labeling Rule, which contains a statement in its preamble about the FDA's pre-emption authority, was written."
"And I now," Mr Troy states, "advise and represent companies confronting state-law claims that implicate the pre-emptive effect of FDA requirements."
But the fact is, Mr Troy was testing the viability of the preemption argument with judges in state and federal courts long before the new policy was announced in January 2006, by filing amicus briefs on behalf of drug companies and against private citizens in cases involving the new class of selective serotonin reuptake inhibitor antidepressants (SSRI's) back in 2002.
Critics say it's a toss-up between Vioxx and the SSRI's when it comes to the number of deaths and injuries that could have been prevented if the information about the serious health risks known to the drug makers had not been concealed.
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