Monday, May 19, 2008
Well, looks like there could be a change in our notions about bioethics and the protection of human subjects -- The FDA announced, rather quietly, that the United States will not be participating in the Declaration of Helsinki starting next Fall. Integrity in Science reports,
FDA Scraps Helsinki Declaration on Protecting Human Subjects
Drug companies got a green light last week to start using data from foreign clinical trials in new drug applications even if the trials only compare new products to placebos instead of best available treatments. The change marks a sharp departure from the 1989 Declaration of Helsinki protecting human subjects in clinical research, the Food and Drug Administration's previous standard. The new rule, which goes into effect next October, was pushed by drug and device manufacturers, but opposed by numerous public interest, patient advocacy, and consumer groups. The Declaration of Helsinki "is the standard-bearer for international research ethics and enjoys particular respect in the developing world," said Peter Lurie, deputy director of Public Citizen's Health Research Group. Its rejection is "in line with other U.S. efforts to flout international mores."
The new rule's substitute standard says foreign trials should follow good clinical practices (GCP) and include a review and approval by an independent ethics committee. A major difference between the Helsinki Declaration and GCP is the former's insistence on using existing treatments instead of placebos if they are available. The Helsinki Declaration had the effect of extending existing treatments to people in poor countries if they participated in clinical trials.
The change is likely to push more clinical trials abroad, where an estimated 35 percent of all trials submitted to the FDA in new drug applications now take place. Unlike trials conducted in the U.S., companies do not have to submit an investigative new drug application (IND) to the FDA before beginning research in foreign countries. The FDA estimates about 575 of the foreign trials submitted to the agency each year as part of new drug applications do not go through the IND process. The FDA rejected the notion that adopting the self-regulating GCP standard and eliminating references to the Helsinki Declaration "will hurt subjects in developing countries or result in less protection for subjects in foreign studies." GCP requires trial sponsors closely monitor trial behavior and report adverse events, the agency noted.
The blog, Firedoglake, has more and states,
Bush's FDA has just announced that it is going to scrap American participation in the Declaration of Helsinki -- the major international accord on ethical principles guiding physicians and other participants in medical research on human subjects. This isn't a decision involving mere medical bureaucracy -- it in fact clears the way for ethics-free drug testing, especially beyond American borders, and it means people will die, sometimes horribly.
The shift in policy now makes it possible for American drug companies to conduct tests on human subjects (most often in Third World nations) wherein victims of particular diseases can, in the course of testing, be administered pure placebos that do nothing to help them fight those diseases, while being told they're undergoing treatment. (The longstanding standards required such tests to administer the acknowledged standard treatment as the placebo.) . . . .
Over at PAL, Sonia Shah, the author of a book on the subject, also titled The Body Hunters, discussed the consequences of the FDA's decision at length:
With hardly a word in the mainstream press, the FDA has gutted the rules restraining drug companies from exploiting clinical trial subjects in developing countries.
With 80 percent of clinical trials failing to recruit sufficient numbers of test subjects on deadline, drug companies increasingly export their trials to developing countries, where sick, undertreated patients abound. It’s faster, it’s cheaper, and it’s easier to conduct the placebo-controlled trials that companies and the FDA prefer. There is precious little oversight of these trials.
Unlike for domestic trials, the FDA does not require advance notice before drug companies take their trials outside US borders. And with 90 percent of trials failing to gain FDA approval, a massive number of trials are conducted, fail, and then vanish with no agency review at all—and little public record, if any at all.
Until now, the FDA’s sole requirement for these overseas trials is that they adhere to the Declaration of Helsinki (or local rules, on the off-chance that they are more stringent). Signed by the United States and 34 other countries in 1975, the Declaration of Helsinki consists of several dozen pithy principles to govern ethical research on humans, and is widely considered the gold-standard in research ethics. Crafted and updated by the World Medical Association, a group representing dozens of national physicians’ organizations from around the globe, the Declaration of Helsinki (DOH) urges that participants’ voluntary informed consent be obtained, that independent committees to review and oversee trials be used, that investigators prioritize their subjects’ well-being, that research subjects be assured access to the best health interventions identified in trials, and that their societies enjoy a “reasonable likelihood” of benefiting from the results of trials.
... The FDA’s move against the DOH is more than a symbolic change. With drug companies rushing to countries where the domestic regulatory infrastructure is weak at best—India, where Pfizer and GlaxoSmithKline have set up global clinical trial hubs being perhaps the prime example—and the FDA turning a blind eye, the business of protecting impoverished, sick, undertreated patients from exploitative experimentation falls almost entirely upon local people convened by clinics and hospitals to sit on FDA-required ethics committees. Theirs is a nearly impossible job, much of it shrouded in secrecy. Some, from India and South Africa, spoke to me, anonymously. They told me of how their clinics and hospitals desperately need the income drug-industry trials bring in. Of how, often, their bosses sit on the committees with them, pressuring members to approve as many experimental protocols as come in. They are overworked, underpaid, and poorly trained—if trained at all—in the principles of research ethics. Even the most courageous among them find it difficult to challenge problematic experiments and interrupt the flow of industry dollars.