Today’s Adventures in Science!

In somebody’s comments on another blog the other day, a discussion was taking place over the safety of the untested, experimental drugs being more and more insistently pushed upon people for prevention of what is, except for few and generally easily identified populations, a very minor illness. The exasperated pro-drug party was patiently explaining, in scientifilicious terms, how drugs that mess with your cell’s genetic materials are no different or more risky than traditional vaccines.

Maybe he knew exactly what he was talking about, I don’t know, it was getting a little over my head. I was struck by what might be called, with apologies to Darwin, the ‘Darwinization’ of the discussion: just as evolutionary arguments are presumed settled once a plausible scenario is presented under which selection pressures could be imagined to have brought about the observed features or behaviors, the need for actually TESTING THE DRUG has been obviated by a pleasant theory about how it works.

Darwin and his more serious followers recognize they are in a tough spot: testing an evolutionary theory is difficult bordering on impossible even in theory. So you’re going to have to be happy with plausible theories in almost every case. But drug makers have been doing extensive and expensive testing for years. And, sure enough, that testing routinely reveals that, not only do most drugs not work, but many have unintended consequences like, for example, killing you.

ALL of the modern drugs you buy at the drug store were developed at great expense and with great care by experts in Big Pharma. To get one drug approved, many more start the testing process but get cancelled at some point because 1) they harm people; 2) they don’t demonstrably work; or 3) both. Any that do get approved have been run through about a decade and about a billion dollars of testing. Even approved drugs still have risks, but it has been determined through the testing and approval process that the risks are worth the benefit.

Even then, from a strictly scientific perspective, the rigorous drug testing needed to get FDA approval is fatally flawed: in order to truly understand the risks and effectiveness in the real world, you’d need to test across the inevitable drug interactions real people will in practice experience, at least. But this level of testing would mean no new drugs were ever going to get approved. Having drugs tested and approved before they are unleashed on the public is a policy, not a science, question. The policy is to do enough testing to feel good about some level of cost/benefit tradeoff. For the record, this seems reasonable to me, in theory at least.

BUT! Good news! According to the exasperated commenter mentioned above, we can skip all this testing – provided we have a good theory about how the drug can’t have bad side effects! Even the minimal short term testing that was performed was unnecessary in the face of well understood (I’m told) theoretical considerations showing the drug worked harmlessly. All concerns over the mid- and long-term effects, which simply CANNOT have been tested for, are misplaced – THEORY says these drugs are safe.

Big Pharma has to be thrilled! It’s Science!