Carmel, CA FDA Encouraging Drug Companies To Let Critically Ill Try Experimental Drugsby Richard Kuehn on 10/25/12
I've written many times on my blog about the controversy surrounding the expedited approval process of drugs by the Food & Drug Administration (FDA). Some argue that this is resulting in unsafe drugs being brought to market while others argue they are saving lives. I think it depends upon the drug. If someone has a terminal illness and there is nothing on the market that is helping their disease, I think they should be able to take whatever drug they can find, and it should be pointed out to them that all risks may not be known. I was happy to read that this is being done in some cases. The article discussed how a Doctor who, via an accidental pin prick, contracted Hepatitis C which also brought on a brain disorder called encephalopathy as well as liver cancer. Nothing was working on her and after two liver transplants and continued medical problems, she was at her wits end. However, the FDA allowed her and about 1,200 other patients to get special compassionate-use treatment for experimental drugs. Although this is a tiny number of people, it's up 20% from the 1,000 patents helped in 2010. One reason that more people haven't been helped is that the FDA has had a hard time getting some pharmaceutical companies to participate in the program. After fighting with the drug companies for years to use experimental drugs, the woman profiled in this recent article finally got one to agree to give her experimental drugs and she is now free of the hepatitis virus and her third liver is working fine. Although taking an experimental drug like this is fraught with risks, I am glad that this one patient was saved by the compassionate-use program and I'm sure having patients try these new drugs gives the pharmaceutical companies better information about side effects.