Posted by Human medicine advances in the way much of science does. People make systematic observations, form plausible hypotheses, and collect data. One of the more important questions in medicine is how people are affected by certain exposures. When that exposure is a medicine, we prefer data from double-blinded, randomized controlled trials. Other types of exposures (such as cigarette smoke) are less amenable to RCTs and we must rely on case-control, cohort, and other studies that examine correlation.
But before we can run RCTs on human subjects we need more than just a plausible hypothesis; we need to know that the medicine appears to be safe and effective in a biological system. Usually, we use animal models, with the choice of species being dependent on the study design and the biology of the drug and the disease. By choosing this approach, we have made a value judgment: human health is important enough to allow us to test drugs and procedures on non-human animals. Our alternatives are limited: either we test drugs first on humans, or we don’t develop new drugs.
So I was watching my local PBS station yesterday (perhaps for the last time) and I came upon Dr. Neal Barnard shilling some book or other on curing diabetes. That pissed me off enough to go to his website and check him out, but before I got into the other details I see that he founded something called the Physicians Committee for Responsible Medicine (PCRM). I vaguely recall hearing about this group during medical school. There were some students who joined as advocates of “ethical animal research”, apparently unaware that ethics are already a big part of animal work. Since then, I haven’t thought about the group.
Until now.
Any group founded by a doctor promoting questionable practices might itself turn out to be a bit questionable. The site looks just fine, and Dr. Barnard brings up many seemingly reasonable points:
PCRM advocates higher ethical standards in conducting human research and providing access to medical treatment.
Ethical standards are pretty high already, so I was curious what he had in mind. He starts off talking about previous work that was unethically, such as the Tuskegee Syphilis study. That’s fine, but most of us already know this stuff. He brings it home with this:
A more widespread ethical problem, although one that has not yet received much attention, is raised by new pharmaceuticals. All new drugs are tested on human volunteers. There is, of course, no way that subjects can be fully apprised of the risks in advance, because that is what the tests are conducted to find out.
Here’s how this works. Phase I trials of new drugs are the first level of human study and are designed to test toxicity and the pharmacologic characteristics of new drugs. This is typically done with small groups. If it seems likely that the drug is safe, phase II trials are run as a basic test of efficacy. If these go well, large phase III trials are run to see how the drug acts in the population in question. At this point rarer adverse events may show up, but really rare adverse events might not show up until millions of people are exposed and identified in post-marketing surveillance.
Because we want to develop drugs and devices to help humans, and because we don’t love the ethical implications of jumping straight into human trials, we usually run animal models before Phase I trials. What Barnard and the PCRM are asking for in demanding “higher ethical standards” is unclear, because after stating his concern for human subjects he states:
Human beings, of course, are not the only potential victims of unethical research practices. Given the emerging history of abuses and secrecy in human experimentation, the idea that animals–the 20 million chimpanzees, cats, dogs, and rabbits used every year in laboratories–will somehow be better treated is unconvincing, to say the least. Whether the subjects are humans or animals, any assumption that experiments are always necessary, always carefully monitored, and always ethical is a fiction.
Aside from the obvious Nivanna fallacy here (“since things aren’t perfect they are entirely bad”), his argument boils down to a horrific nihilism. He is arguing against animal and human trials, which means we cannot develop new drugs and devices. What, then, can we do about human health and disease? Apparently he thinks everything can be fixed by a vegan diet, but I’m sure it’s more complicated than that. Still, I shudder to think of a world where people like Barnard use their muddled, disingenuous reasoning to halt vital research.
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