Thursday, April 07, 2005

In which I utter the scariest words in the English language

I think the guy from the Cato Institute might have a point

The link, which is from Pandagon is about whether people should be able to buy drugs that the FDA has deemed are dangerous. They would have to sign a form promising not to sue the drug manufacturer before they could buy the drugs. I realize there are big problems with this, but I can see the benefits.

The thing is, people have a very mistaken notion that drug safety is a black and white thing. Either a drug is safe or it is not. And in fact, that's not right at all. All drugs, including very common and uncontroversial ones, carry risks. All approved drugs carry benefits. Someone has to decide whether the benefits outweigh the costs. And I can sort of see the argument for thinking that the patient, rather than the government, should get to decide when it's worth taking the risks.

This comes up most often, I think, with drugs that improve people's quality of life. It comes up with pain meds like Vioxx, for instance, or with hormone replacement therapy, which alleviates the symptoms of menopause. Because quality of life isn't quantifiable, it's hard for researchers to acknowledge the benefits. It seems irrational to risk serious illness or death, things that can be measured, so that you can live without discomfort, something that is difficult to measure or convey. Agencies like the FDA tend, I think, to treat quality-of-life concerns like they're trivial, and they tend to assume that people who give in to those considerations are stupid or weak. They may be right, but it seems to me that people ought to be able to make their own choices on these matters.

The problem, I think, has to do with ensuring that people have the information necessary to make informed choices. If I had terrible arthritis, I might be willing to take a drug that would take away my pain but had a 1% chance of killing me. I would definitely not take a drug that would cure my arthritis but had a 40% chance of killing me. If you force people to sign away their rights to sue, you also take away the drug companies' incentive to provide accurate information about the risks associated with their drugs. We'd need to come up with a better system to ensure that people got accurate information.

Comments:
Dangerous or not / Approved or not we do need a much better system.

I take two, relatively safe drugs to treat MS. Because these drugs are FDA approved, but NOT for the treatment of MS I have a difficult time getting them Rx'd despite the fact that clinical data shows them to be about 85% effective in controlling disease progression. However, I can get Rx's easily for much more dangerous drugs simply because the FDA has approved them for my use.

The approved dangerous drugs are pushed (hard) by the drug companies, they cost at least $1,200 month, and are very iffy in results (like 30% of users get a possible 30% reduction in disease progression). I refuse to take them.

I should have the right to good, unbiased information and to make these decisions for myself and my life - and YES - quality of life is a huge issue.

Sorry for this rant but it is a "nerve" issue with me.
 
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