Yesterday, I noted that Biogen and Elan had taken their joint blockbuster drug, Tysabri, which treats MS, off the market temporarily because 2 patients had developed progressive multifocal leukoencephalophathy (PML). Each of these patients were taking another drug, and one of them has died from the condition.
Tysabri had been approved under the FDA's "fast-track" approval system, and some articles are now saying that this recent series of events may bring about another bout of hysteria about drug safety and call the FDA's fast-track system into question (this last link is to a WSJ article and requires a subscription). I say "poppycock" to that.
First, I want to be clear that I do not mean to diminish the loss of the patient's family by any means and my deepest condolences are extended to them.
But some of the other drugs that made huge headlines (Vioxx, Celebrex, etc.) potentially harmed hundreds of thousands and there are allegations that their makers hid the potential adverse reactions for years and that the FDA was possibly in cahoots with them. Here, we have 2 patients of thousands that were taking Tysabri, and Biogen and Elan acted fairly quickly to suspend sales of the drug. It's very probable that Biogen and Elan acted conservatively because they knew that bad publicity may come about. But because they acted swiftly to suspend Tysabri, I think any hysteria is going to be welched quickly.
As for the FDA's accelerated approval mechanism being called into question, I suppose some will try to hold hearings on this and get to the bottom of things. But the accelerated approval is supposed to be for drugs that treat life-threatening diseases. Unfortunately, even with the best drugs in the world, it's a good bet that a drug might adversely affect someone whose immune, skeletal or hematological system is already strongly compromised. No one, including this blogger, wants to see someone die because they took a chance and tried a drug that was supposed to make them better. But not everything in a human body is 100% predictable and horrible results sometimes come about and there is no way under the current state of technology that a doctor or researcher could have known who would be affected. They can work as hard as they can, and have all the previous research show that it's safe and effective, and there may always be at least a few people who have slightly different biochemical or mechanical make-up who do not react positively to the treatment.
The accelerated approval process could use some tweaks, no doubt. The FDA really should be getting enough data to show that the drug is safe and effective and shouldn't be just rubberstamping any drug that comes through the fast-track. I haven't yet seen the evidence that the accelerated approval process is riddled with more errors or problems than the regular approval system. I know that might not be the highest standard to follow, but when it can't be conclusively proven that making all drugs go through the slower process is always the right course, I don't feel the case has been made to close off an avenue that could get some drugs to the patients who really need them in less time.
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