The cure for what ails you: But only if you can get it in time.
Courtesy Destinys Agent
(With the Republican National Convention literally across the street, the Science Museum of Minnesota will be closed starting Friday, August 29. But Science Buzz marches on! To honor our convention guests, I’ll be posting entries focusing on issues where science and politics overlap. Hopefully this will spur some discussion. Or at least tick some people off. Previous entries here and here.)
Getting a new drug approved for use is a long and arduous process. As well it should be—we need to be sure not only that the drug works, but also that it doesn’t have any nasty, even fatal, side-effects.
Unfortunately, the process has gotten slower lately. The US Food and Drug Administration is approving only half as many drugs as it did a decade ago. Some observers believe the organization has grown gun-shy. After Vioxx and a few other high-profile drugs had to be pulled from the market over safety concerns, the agency has become a lot more cautious.
(The cynical among us might say the FDA is out to protect its own skin, regardless of how many lives are lost by withholding drug approvals. At the same time, one can argue that they agency has been forced into its current cautious approach by the media and Congress, who heap criticism and blame on the FDA for its few mistakes, but never offer any praise for its many successes.)
Another issue arises from the pre-approval trials. New drugs are tested on a small number of patients. Often there are more patients interested in taking part in the trial than there are slots available. This can be especially difficult for terminally ill patients who have exhausted all other treatment options – nothing has worked, and they are still dying. They would have nothing to lose, and potentially a lot to gain, from trying an experimental drug. The drug trial itself might benefit from having more subjects. It’s win-win.
But getting such patients added to trials has proven very difficult. In May, Sen. Sam Brownback (R., Kan.) and Rep. Diane Watson (D., Calif.) introduced a bill to open up access to trials for such patients. No action was taken before Congress recessed for the summer.
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