Seems to be another topic de jour: FDA corruption and wink-wink quick acceptance of potential blockbuster drugs into the marketplace. Of course, nobody plans to injure the consumer, the point being inadequate testing is conducted so that drug companies can start selling promising drugs.
WSJ.com - Are Too Many Unproven Drugs Receiving FDA Early Approval? Process Comes Under Scrutiny:...
With the Food and Drug Administration's handling of drug safety already under a microscope, the suspension of multiple-sclerosis drug Tysabri creates a new area for scrutiny: the agency's process for rushing out promising new treatments for the most serious conditions.
Biogen Idec Inc. and Elan Corp. yesterday announced that they would suspend Tysabri from the market and from clinical trials after confirming that one patient had died of a neurological condition called progressive multifocal leukoencephalopathy, or PML. They said a second patient also may be afflicted with it. Both patients were in clinical trials and had taken the drug in combination with another medication, Avonex.
What sets the Tysabri case apart from other recent drug-safety controversies is that it was allowed on the market through the FDA's “accelerated approval” program. Under that mechanism, a drug that treats a life-threatening disease and represents a significant improvement over available therapies can win approval with less data than typically required, though the company is supposed do a follow-up study.
In an analysis that was presented last year at a meeting of the American Society of Clinical Oncology, and later updated, researchers found that of 26 uses for cancer drugs that won accelerated approval, six had serious new adverse events that were discovered only after they went on the market. In addition, only nine of those uses had new, fuller data reviewed after the accelerated approvals, and just six had accelerated approvals converted to full approvals. No accelerated approvals were revoked.
Now, researchers, patients and the agency itself will have to ask whether the potential danger with Tysabri could have been discovered before the drug won accelerated approval. The two cases involve patients who had taken the drug for more than two years, and Tysabri was approved based on about one year of data. If the FDA followed its more typical procedure of waiting for two-year data on multiple-sclerosis drugs, the cases might have surfaced during the review and “they probably would not have approved the drug,” says Aaron Miller, chief medical officer at the National Multiple Sclerosis Society. Yet he says it isn't easy to second-guess the agency. “The FDA has a real challenge and a balancing act that they need to follow. They need to make effective drugs available sooner to people with serious diseases,” he says. Tysabri “looked like a very promising drug.”The Tysabri suspension will add a difficult line of questions for the FDA, which already is under congressional scrutiny. Yesterday, Senate Finance Committee Chairman Charles Grassley, an Iowa Republican, introduced a bill with Democratic Sen. Chris Dodd of Connecticut that would force drug makers to disclose more clinical trial results. Tysabri is likely to come up in a Senate hearing on safety and the agency's drug-approval process scheduled for today. It comes as some outside researchers already were questioning whether the agency's accelerated-approval process has become too widely used, potentially allowing some drugs on the market with only limited evidence of efficacy and safety.
“All of us have to raise our expectations of when a drug is good enough to be put out there,” says Silvana Martino, a clinical associate professor at the University of Southern California who heads the FDA's oncologic drugs advisory committee. “It requires time for certain toxicities to occur, and it requires more people to be treated.”
