Controversial MS drug endorsed by scientists-liability?

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FDA Advisers Endorse Return of Multiple Sclerosis Drug

Tysabri’s manufacturers, Biogen Idec Inc. and Elan Corp, pulled the drug off the market in February 2005 after three patients taking it developed progressive multifocal leucoencephalopathy (PML), a progressive, neurodegenerative disease. Two of those patients died.

A U.S. Food and Drug Administration advisory panel voted unanimously Wednesday to allow the promising but controversial multiple sclerosis drug Tysabri back on the market.

Now, naturally, the FDA has to approve this action, but generally they go with the scientists. So here’s the problem:

In the not-so-distant past drug manufacturers have been sued for side-effects of their products. The one that comes to mind right away is Vioxx. Merck has been sued 15 ways to Sunday over the drug. This drug, which is known to kill people, is being demanded by MS sufferers.

MS patient and attorney Karen Miller, 49, told the committee that Tysabri “is as close as it comes” to a miracle drug. Miller credited the drug with a renewed ability to ride her bike, wash her windows and run daily errands, the AP said.

“I am at the end of my road, in terms of what I can take. I want it to be my choice,” another MS patient, Barbara Crooks, 48, told the news service.

Now, even with the utmost concern for safety it is said that 1 out of 1,000 people will die as a result of using this drug. These people are demanding it. Should the company put this drug back out on the market without an iron-clad agreement that they will not be prosecuted for the deaths of their customers? Should the families of the people that will undoubtedly die be allowed to sue them for damages or hold them liable? In my opinion, absolutely not, especially since the drug was pulled immediately, voluntarily and responsibly before and is only under consideration for re-approval because people want it.

So, here’s the debate: should the company get legislated immunity, should they require some sort of waiver, or should they just hope that nobody else dies, even though the odds are stupedously against that? Should they have any liability for the informed actions of their customers? If not, should this be a model for all drugs to follow?

Are we on our way to an informed consent/ personal responsibility model of drug consumption, or is this going to be an exception?

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As someone who was on the trial for this drug (I have Crohn’s disease, not MS, but the drug works well for both) I would like to point out that that the three patients who suffered PML were in fact on a cocktail of highly unpleasant drugs, not just the Tysabri, which would have increased their chances of developing PML, and anyone who was on that particular drug regimen would be pretty far gone in their disease. In addition their MS was pretty advanced and had they not been taking the Tysabri they may well have died even earlier. It is also possible (though, I admit, not likely) that they may have contracted the disease anyway, as it is present in a very small number of the general population. In summary, I think the FDA should certainly approve this drug.

On a more general note, I cannot understand why so many people believe medication is/should be risk free. I personally believe that drug companies should not be held responsible for the side effects of their drugs unless (as has been the case with certain psychiatric drugs) the company has wilfully withheld information as to the safety of their drugs. Indeed perhaps all drugs should be accompanied by an informed consent form. This would at the very least make those people who seem to demand chemical appeasment as a matter of course for the slightest (lifestyle caused) ailment think twice about what they are shoving into their bodies.

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Should the families of the people that will undoubtedly die be allowed to sue them for damages or hold them liable?

I doubt this would be possible, as they would have had to sign informed consent forms (different versions, many times if my experience is anything to go by) and those forms explicity state that the company will not be liable for death or injury from any side effects (although they do pay for any medical costs incurred due to the use of the drug)

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So are you saying that this compny should NOT put this drug back on the market because they can’t be assured that they won’t be sued into oblivion? Or that they shouldn’t get some sort of immunity?

[Fast_n_Bulbous]

I think they should have immunity from being sued. The fact that Tysabri was taken off the market as quickly as it was shows that the FDA was doing its job well and that the reporting of possible side effects was taken seriously by the company. Indeed, I believe that the risk management by a lot of drug companies is somewhat over-the-top. If, during the trial of a drug, one of the trial patients reports having a headache, headaches are noted as one of the side effects of the drug, whether or not the headaches were caused by the drug. The same with PML, or any other condition. Given all of this anybody taking the drug should be aware that there are always risks, and should be able to weigh up the benefits and risks for themselves, in consultation with their physician. If they then experience a side effect, the drug company should not be blamed.

Of course if there was negligence on the part of the drug company or the FDA then that is a different matter altogether, and I would think a criminal, as well as civil, matter.