Medical experts are now predicting another Vioxx-like disaster with Avandia. In May 2007, prominent cardiologist Dr Steven Nissen, of the Cleveland Clinic, reported a study in the New England Journal of Medicine that found the drug to be associated with a 43% increase in heart attacks and possibly a 64% increase in cardiovascular death.
In a May 26, 2007, speech on the Senate Floor, Senator Charles Grassley (R-Iowa) said that the actual number of heart attacks possibly linked to Avandia may be as high as 20 a day.
Since the drug came on the market about 8 years ago, he said, tens of millions of prescriptions have been written, and Medicare and Medicaid have paid hundreds of millions of dollars for the drug.
At a June 6, 2007, hearing of the House Committee on Oversight and Government Reform to review the FDA's failure to warn the public about Avandia, Chairman Waxman (D-Cal) began the meeting by pointing out: "It is not Congress' role to adjudicate these medical issues."
"But it is our role," he noted, "to ensure that the Food and Drug Administration is taking these concerns seriously and providing doctors and patients with the guidance they need to make informed decisions."
"Although Avandia has been on the market for eight years and has been used by millions of Americans," Rep Waxman said, "the post-market studies have not been done to say conclusively whether Avandia increases or decreases the risk of heart attacks."
"That's a major failure of our system," he said. "And it is what is causing so much confusion and worry among the patients who are taking Avandia today."
Another FDA failure that will surely lead to many lawsuits was allowing Permax (pergolide), a drug used by Parkinson's patients, to remain on the market until March 29, 2007, long after its link to valvular heart damage was known.
Eli Lilly gained approval for Permax in 1988 but, at the time of the recall, the drug was manufactured by Valeant Pharmaceuticals and generics were sold by Par and Teva.
As early as December 2002, doctors at the Mayo Clinic reported that 3 Permax patients had developed heart valve disease similar to that caused by the Fen-Phen diet combination. In 2004, HealthDay News reported that a study had confirmed earlier findings that Permax was linked to heart valve damage which required surgery to correct.
On January 4, 2007, two studies in the New England Journal of Medicine said that the number of patients developing valve damage was higher than expected. One study found moderate to severe valve problems in more than 23% of the patients on Permax, compared to less than 6% in the comparison group.
The second study found Permax users were 5 to 7 times more likely to have leaky heart valves than patients taking other Parkinson's drugs, and patients taking the highest doses of Permax were at a 37 times greater risk.
The FDA's preemption policy has the potential to benefit every major drug company. Johnson & Johnson's SEC filings show that the company is currently facing hundreds of lawsuits over the deaths and injuries linked to the Ortho Evra birth control patch in women all over the country who have suffered blood clots, heart attacks and strokes.
Legal analysts predict that many more lawsuits will be filed due to the wide use of the device and as women realize that their injuries are due to the patch. In 2005 alone, there were more than 9.4 million prescriptions issued for the Ortho Evra patch, according to IMS Health, an industry-tracking firm.
A preemption ruling in this litigation would be especially onerous in light of the fact that the injuries are clearly due to the patch, because blood clots, heart attacks and stroke are almost unheard of in the age group of women who use this device.
This is another case where FDA officials knew of the health risks before the drug was approved. Agency records show that in 2000, the FDA scientist in charge of reviewing the preapproval trials submitted, warned that blood clots could occur and recommended that the information be included in the prescribing information for the patch.
