At the risk of a system overload, I would like to heap another urgent call for action onto the Obama administration's very full plate. As the nation goes to war over domestic health-care reform this summer, it is time to critically examine one more parting present from former President George W. Bush that has yet to be unwrapped. The "midnight pardon" for global pharmaceutical companies that Bush granted has reopened the door to exploitation-driven profit.
In October, the Food and Drug Administration was allowed to officially discontinue reliance on the World Medical Association's Declaration of Helsinki, a regulatory document for international biomedical research ethics, and supplant it with a set of guidelines drafted by business representatives from the world's richest countries. Why should we care? Until last year, all international trials conducted by American research teams were subject to the ethical regulations laid out in the internationally-composed Declaration of Helsinki, often viewed as the cornerstone of research ethics. The FDA's substitute, representing the voices of only the United States, European Union and Japan, is the International Conference on Harmonization's "Guidelines for Good Clinical Practice." Sounds great!
At least, it does if you are not a potential participant in a medical research study in the developing world (read: a sick poor person). The GGCP is defined more by what it does not say than by what it does several key omissions constitute a disturbing and misguided departure from global consensus on research ethics. The GGCP does not hold investigators responsible for publishing results regardless of the outcome or for providing post-trial care for study participants. Most importantly, the document is too open to the use of placebos, meaning that if you are a participant in a placebo-controlled study, you have a 50-percent chance of receiving absolutely no treatment for your disease.
The use of placebos has been the subject of growing debate in the field of medicine. Many alternatives exist, including active-controlled trials where participants receive either the study drug or the best available alternative for purposes of comparison. A study was conducted by Dartmouth's Global Health Initiative on a possible tuberculosis vaccine for HIV-coinfected patients in Tanzania that provided all patients with the best possible HIV and TB treatments regardless of whether they received the actual vaccine.
Imagine that your only chance for a cure for a deadly disease was to enroll in an experimental trial of a potential new treatment and at the end of the study you discovered that the drugs you had placed your last hope in were nothing but sugar pills. The group conducting the experiment has already picked up shop and left the country, leaving you to die because you lost the coin flip that gave you a 50-percent chance to have a hope of survival. This is the reality faced by millions of the world's destitute sick when proper regulations do not hold companies accountable for whether they are providing a fair-benefits framework to the patients who make scientific progress possible.
When my own late father was battling leukemia, my family was approached by a research team that asked him to forgo existing chemotherapy in order to participate in an RCT for a new type of treatment; unlike millions of patients around the world, my family had the option to refuse, and we did never wanting to accept the risk that he could receive a placebo. No one could make that choice, even in the name of biomedical progress. But when the driving concern is money and the people in question are the sick international poor, why would a pharmaceutical company bother trying to sensibly demonstrate that a new drug is better than the best existing treatment when it is possible to profit simply by proving that it is better than nothing?
The FDA's morally imperialistic rejection of the Declaration of Helsinki facilitates the exploitation of some of the world's most vulnerable populations. Unless our country is willing to accept a new ethical order that harkens back to the days of the infamous Tuskegee Syphilis study, we must demand that this parting gift from Bush be handed back before further damage is done and other nations start to follow the United States' lead. As we tackle the issue of health care reform at home, we must not forget our ethical responsibilities to the rest of the world.
