Non-Partisan Watchdog Group Files FDA Petition to Better Protect Drug Trial Participants
Unreliable Drug Testing Practices Put Clinical Trial Participants and Consumers At Risk, Contends the Center for Responsible Science
Los Angeles, Calif., July 17, 2014--The Center for Responsible Science (CRS), a non-partisan, nonprofit watchdog group advocating for more modern and accurately predictive test methods for new drug development, is warning the public that conventional drug testing may put the health of clinical trial participants and consumers at risk. CRS has filed a citizen petition with the Food and Drug Administration (FDA) to update its informed consent regulations so that clinical trial participants will no longer be kept in the dark about the hazards they may unwittingly assume when they agree to participate.
Currently, drug manufacturers do not disclose to clinical trial participants that preclinical testing, which relies heavily on FDA-mandated animal testing, rarely predicts human drug response accurately. Failure to disclose this level of risk to human safety renders the FDA’s informed consent process faulty. Drug trial participants must receive meaningful warnings so they can decide for themselves if the uncertainties and risks of trial participation are warranted.
Many drugs that have appeared safe in animal studies have caused severe adverse reactions and death when given to humans. Because of a lack of published reports, it is unclear how many people suffer these consequences as a result of taking drugs administered in U.S. clinical trials. This uncertainty makes it even more important that the FDA update its regulations and issue proper warnings to trial participants.
“The FDA admits that 92 percent of drugs fail in humans even after the drugs tested well in preclinical studies,” said Mark Mazzarella, CRS’ lead counsel. “In light of the convincing evidence that human subjects are currently participating in clinical trials without a full understanding of the attendant risks, there is no public policy justification for a refusal by the FDA to act.”
Said CRS co-petitioner John Tessmer, a former clinical trial participant: “I do not believe that I should be asked to risk my health until I have been given the disclosure that this petition requests--that is, information that a reasonable person would need to make an informed decision with regard to the real risks posed by the clinical trial. I don’t believe anyone else should either.”
The Center for Responsible Science (CRS) is a California 501(c)(3) nonprofit organization. Its mission is to save lives by tackling the root causes of inefficient, outdated drug development. CRS works to expose and address issues threatening the health, public interest or well being of Americans. This informed- consent citizen petition is the first of several petitions CRS plans to file in an effort to update Food and Drug Administration policy.