Several of the bloggers here at SBM have repeatedly criticized various clinical trials for so-called “complementary and alternative medicine” interventions for various conditions and diseases (or should I say dis-eases?) for being completely unethical. Examples include the misbegotten clinical trial for the Gonzalez protocol for pancreatic cancer, which — surprise, surprise! — ended up showing that patients undergoing Dr. Gonzalez’s combination of 150 supplements a day, dietary manipulations, and coffee enemas, actually did much worse than those undergoing standard of care, despite how depressingly poor the results of standard of care are; clinical trials of homeopathy in Honduras and other Third World countries, which both Wally Sampson and I lambasted; and ongoing clinical trial of chelation therapy for cardiovascular disease. I’ve also criticized the “autism biomed” movement, that amalgamation of parents who believe that vaccines cause autism and yet are willing to subject their children to all sorts of quackery to “cure” the “vaccine injury” of uncontrolled and unethical experimentation on autistic children. As valid as all these criticisms are, it is important to recognize that science-based medicine is not free of its own abuse of ethics.
A couple of weeks ago, I wrote about the concept of clinical equipoise. Clinical equipoise is a critical concept in any clinical trial. Basically, a state of clinical equipoise exists when there is genuine scientific uncertainty over which of the options being tested in/on living, breathing human beings is better, and any clinical trial in which a state of clinical equipoise does not exist is at the very least ethically dodgy and probably downright unethical. For example, when the occasional anti-vaccine activist argues for a randomized controlled clinical trial comparing vaccinated children and unvaccinated children, it’s easy to shoot that idea down as unethical because there is no clinical equipoise. The children receiving placebo vaccines would be put at a much higher risk of suffering harm compared to the vaccinated children because they would be left unprotected against life-threatening diseases. In the realm of conventional medicine, the reason that few cancer clinical trials involve a placebo control group anymore but instead test a new therapy either against the standard of care or with the standard of care is because in many, if not nearly all, cases placebo use in a cancer patient is unethical when there exists effective therapy, even if the therapy is not all that effective. What all this boils down to is that science is only part of the basis of science-based medicine. Medical ethics must take precedence. After all, arguably the most efficacious way to test a new antibiotic would be to infect people with the bacteria the antibiotic treats and then divide these people up into a placebo control group and a group receiving the antibiotics to see how each group does. After all, this is the sort of thing that the Nazis and Japanese did during World War II, and the same sort of dehumanization and abuse of research subjects that every ethical precept regarding human subjects research that has been developed since then, such as the Helsinki Declaration of 1964, has been designed to prevent.
Unfortunately, medical scientists in the U.S. have not always lived up to these precepts. The most famous example is arguably the Tuskegee syphilis experiment, in which poor black men with syphilis were studied and the control group denied effective therapy for syphilis even after it was known that penicillin was an effective treatment for syphilis. This study spanned 40 years, from 1932 to 1972, and is justifiably held up as one of the worst examples of research misconduct in American history, if not the history of the world. The shock the revelation of this study to the American public in 1972, when it learned of men dying of syphilis, women contracting syphilis, and babies being born with congenital syphilis, all unnecessarily, led to Belmont Report and the establishment of the Office for Human Research Protections (OHRP).
It turns out that there was an even worse atrocity against medical science perpetrated by U.S. investigators in Guatemala over 60 years ago that only now has come to light in stories in the New York Times, MSNBC, and elsewhere. So bad was the offense that Secretary of State Hillary Clinton and Secretary of Health and Human Services Kathleen Sebelius have issued a formal apology to the Guatemalan government for the experiments in which Guatemalan prisoners were intentionally infected with syphilis and then treated with antibiotics, an apology that President Obama reiterated in a personal telephone call to Guatemalan President Alvaro Colom on Friday.