Instituted in the 60s, clinical drug trials today have become a vast and
expensive enterprise in which drug companies can spend over $100 million to bring a new molecule to market. FDA procedures are complex and elaborate as they should be, in order to bring new drugs to market quickly to help people in need, but to do good science to protect the public from a drug's potentially dangerous side effects.
One thing we have to recognize in this country is that a lot of people sign up for clinical trials because it's the only way they can get effective treatment of any kind.
-- Alexander Capron
Bioethicist Professor of Law & Medicine, USC
Once you delve into it, the entire arena of clinical drug trials is a tangle of hidden moral, ethical, legal, and philosophical complications. Say you want to enroll your seven year-old for an experimental HIV drug but the kid doesn't know he or she has HIV and you don't want to tell them because kids blab. If they talk about it, the family may be ostracized or thrown out of their neighborhood. What about the altruistic man in Philadelphia who had a non- life-threatening genetic disease, volunteered for a genetic therapy drug trial, was a borderline case for admission, and then died because of the treatment? Then there's the ethical issues of drug testing in third world countries. Are we exploiting the people by using them in trials, or are we helping them by bringing medical care and leaving them with training, organization, buildings and equipment? And what if we only leave them with buildings and no training?
How can we humanely accelerate the process of bringing valuable drugs to market?
Most promising is "dry testing" of drugs by supercomputer simulations, a new field called computational biology. There are no ethical problems when messing with silicon.
Delve deeper into this episode’s content.
Professor of Law & Medicine, USC
Alexander Capron discusses current issues in bioethics.
Andrea Kovacs M.D.
Dir. HIV Family Clinic, USC
Andrea Kovacs on pediatric AIDS.
Robert Temple M.D.
Assoc. Dir. Medical Policy, FDA
Robert Temple talks about his work at the FDA.