Risking the Benefits

There are two great pieces regarding Vioxx I wanted to point out. The first is this column by Steven Milloy of JunkScience.com as it appeared on the Fox News Web site.

Vioxx is a poor excuse for any drastic action as there has been a tremendous overreaction to the reports that the drug may be a heart attack risk. Merck, the drug’s manufacturer, probably erred and fed the frenzy by withdrawing Vioxx from the market completely. True, the Vioxx clinical trial launching the panic reported a doubling of the heart attack rate. But the baseline heart attack rate was relatively low (15 versus 7.5 out of 1,000 Vioxx users) and the increased heart attack rate was only apparent after 18 months of continuous Vioxx use (a period of time that constitutes overuse), as pointed out in the Wall Street Journal.

Merck should simply have re-labeled Vioxx with new warnings that the drug shouldn’t be prescribed to those with a history of cardiovascular and gastrointestinal problems, or for too long periods of time.

Congress should be leery of creating another federal program the sole mission of which is to find fault with easy-to-demonize businesses — especially at no risk to the program itself. We already have a government program like that. It’s the U.S. Environmental Protection Agency’s Superfund program for cleaning up hazardous waste sites — and it doesn’t work very well.

Read the whole thing. I don't know why government regulation is everybody's answer to everything. Vioxx is a bad example to use as a basis for government regulation. The two biggest reasons our healthcare system is so expensive is because of frivolous law suits and over-regulation. Vioxx is going to bring about more of that and unnecessarily so.

The next is from an unexpected source, the New York Times . As Michelle Malkin points out, there are many people who are willing to risk side effects of experimental drugs just to deal with more pressing problems, like Parkinson's: Many See Hope in Parkinson's Drug Pulled From Testing.

Amgen's move has provoked an outcry from patients who say the company is robbing them of their only hope. "It's almost the same thing as a diabetic losing their insulin," said Mr. Kaufman, who is 50 and has had Parkinson's for 10 years.

The story of Amgen's drug shows the clash between the faith of patients and the cold logic of science and business. At a time when public debate is focused on whether unsafe drugs like Vioxx are remaining on the market too long, this story shows patients who are more than willing to accept risks to get a drug. Their willingness also raises an ethical question: If a company stops developing a drug for safety or efficacy reasons, is it obligated to continue supplying it to patients from its clinical trials?

I totally understand about the risks associated with treatment. I have cluster headaches and take a drug called Imitrex, which has serous side-effects related to heart problems–similar to Vioxx. The difference is that I don't take the drug continually, only when I have a headache. Removing Imitrex from the market because of the heart risks would be devastating to me and my ability to work. In addition, I've been through the Parkinson's issues with my late father-in-law. I know that people are willing to take the lesser of two evils.

To use risks as a barometer for determining whether or not a drug should be on the market would eliminate virtually all prescription and over-the-counter meds. Merck did make a mistake in pulling the drug. As long as there are lawyers who profit at the expense of their clients and crusaders who love to wage PR battles against "big business", the free market suffers. It's insulting to those of us who know the risks of medication, but choose to take those risks to have a life. I don't see how more regulation is going to make us better off.

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