Science and Politics: Improving Access to Experimental Drugs

The cure for what ails you: But only if you can get it in time.
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.

Your Comments, Thoughts, Questions, Ideas

jane180's picture
jane180 says:

Obviouly newer, better medicines are important. And letting people who are already in death's path try experimental medications...well, you have to wonder. The side of that is the medicine being close to affordable and getting an insurance co to help pay for it. Even if Lyrica had helped my Fibro, I could not have afforded to get it, and I have insurance! What about the nearly 50% of working people who don't!! Wonder how much the drug companies are willing to give away.

posted on Mon, 09/01/2008 - 1:09pm
Anonymous's picture
Anonymous says:

Would like to know if I am alone out there about eatting dirt. Since I was really youg I have enjoyed playing in dry dirt, I have Cerebral Palsy and have noticed that when I smell dust or roll around in dirt my pain goes away and I feel great. Would like to know if I am crazy or their are other people like me, I can play in dirt and my pain is gone

posted on Wed, 09/03/2008 - 3:51am
Anonymous's picture
Anonymous says:

When a patient is terminal or has no other option there can be no rational reason to deny access to drugs in clinical trial that a physician believes may help.

It is ludicrous to argue that it would be dangerous to the patient. The patient is already terminal or has no other option.

Further the patient should be required to release the manufacturer and physician from liability and results of such use would be available to the FDA and the manufacturer. Accordingly, the drug company must be required to provide the drug at the same cost as that charged to the clinical trial.

Insurance companies should be required to cover costs associated with use of the drug just as they cover costs with an approved drug which is later removed from the market

posted on Fri, 09/05/2008 - 7:45pm
AdaWakeman's picture
AdaWakeman says:

Certain death vs experimental drugs, no contest in my book. WELL INFORMED patients should be permitted to take experimental therapies when their “tried and true” treatments are not adequate. I’m saying that both as a nurse in a drug detox clinic, and as the daughter of someone who attempted to get into a clinical trial, knowing it was their only chance. He was well informed, he was a physician, and as such knew he needed experimental treatment to have any hope.

posted on Thu, 12/18/2008 - 12:33am
Timada42's picture
Timada42 says:

I don’t see how the agency being more cautious is a bad thing. Drug treatments can be highly dangerous for some people or even addictive, they need many years of experimenting before they can be made readily available to the general public. I would rather the delay then risk putting people in danger.

posted on Wed, 12/24/2008 - 6:13am

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