In the U.S. and Europe, the cry has gone up: “Make drug trials easier to pass!”
A bipartisan coalition in the U.S. House of Representatives is busy drafting a bill that would force the FDA to rely less on randomized controlled trials (RCTs) and more on “clinical experience” when approving drugs, according to the watchdog website AllGov.com. A June 18, 2015 article on the site correctly noted that “Clinical experience, including observational study and anecdotal information from patients taking the drug, has been used as part of the drug approval process, but more in a secondary capacity, as it’s not deemed rigorous enough scientifically to be used as a primary source.”
Of course, citizens of conscience are immediately concerned that any decreased reliance on controlled trials would result in less thorough testing of proposed medications. RCTs are nowhere near perfect, particularly when sponsored by the drug companies seeking approval, but the solution is their improvement, not an adventure on a slippery slope below which lies government-approved free reign for the pharmaceutical industry.
Responding to the news of the congressional efforts, National Center for Health Research director Diana Zuckerman told the Wall Street Journal “Clinical experience is something that should be considered as additional information, but absolutely never take the place of scientific data. By urging FDA to get away from randomized clinical trials, drug makers may have more power to urge the FDA to consider data that is favorable to their product.”
Thomas Moore, senior scientist at the Institute for Safe Medicine Practices, added “We don’t know what will happen. Will it open the door to a wholesale reworking of clinical trial requirements? They are pushing the FDA to consider types of evidence that have not been previously regarded as reliable enough.” A former lead medical officer for antimicrobial development and resistance issues at the FDA, Dr. John Powers, said there’s too much variance between human beings to rely on clinical experience.
But parties interested in making testing easier and cheaper for the drug companies are piping up overseas, as well. A group established by the European Society of Cardiology and comprised of cardiologists and representatives of the pharmaceutical industry published a report this year in which, according to the blog Science 2.0, they declared “Randomized controlled trials must be simplified to sustain innovation in cardiovascular diseases, which are still the biggest killer in Europe.” The paper outlines barriers to investing in cardiovascular research and the authors recommend new ways to conduct clinical research to make investment more attractive and bring drugs to market sooner.
One of its authors posited that “Despite marked progress in diagnosis and treatment, cardiovascular diseases are still the biggest killer in Europe and cause substantial morbidity and burden to the health care system. However, drug developers are opting to not develop new cardiovascular medicines, in part due to high perceived risk and development cost.” Such arguments, including the sometimes unspoken yet attendant “…so we must make the tests easier to pass” one, leave laypersons and health professionals understandably asking whether the hen is being put behind the cart or the horse before the egg.
AllGov.com also pointed out that all the original sponsors of the American bill have received campaign contributions from the pharmaceutical industry.