Researchers at Harvard are working on a way to predict adverse drug effects. You might think that clinical trials should do this since clinical trials are the basis for FDA approval. But that’s not how it works. All FDA clinical trials demonstrate is that a drug does what its makers say it will do and won’t excessively harm people during a relatively short period of use. This makes it possible to declare the drug “safe and effective.”
In contrast, adverse drug effects are accumulated over time as a drug is used in actual clinical practice. For obvious reasons, adverse drug effects should be avoided. In practice, drug companies have been found to avoid revealing adverse effects even at the clinical trial level—for example, by failing to share the results of trials that show potential harm with the FDA. By the way, drug companies are not required to reveal these negative results.
The issue of predicting adverse drug effects brought my attention to another, broader issue: the lopsided focus in issues of health and illness on our inside, not on our outside. In my opinion, effective health practices can only come about when we work equally with our inside (each person’s unique biology) and our outside (each person’s unique environment). Why this is so is obvious: health and illness are biological responses to environmental conditions. It is useful to recall that people have some degree of power over both.
Yet in the work on predicting adverse drug effects we have a contribution to and reminder of the dominance of pharmacology in promoting health and treating illness: methods that are all about fiddling with your biology. This is not unique to drug besotted medical practice: the pages of the alternative health periodicals I read are filled with the same message. This creates environmental cues that say, “Dope your biology!”
But are you healthy because you have a healthy biology? Or are you healthy because you live in a healthy environment?
The scientifically correct question is not which drug is the safest and most effective. Nor is it what of all the possible things to take works best. It is what of all possible things that you and we can do is safest and most effective. One of the things you and we can do is examine what “safest” and “most effective” actually mean.
No one that I know of is asking those kinds of questions scientifically.
That doesn’t mean you and we can’t.
I hope you’re not surprised to learn that civilians like us don’t think about and act on questions of health and illness as if they were a scientific project. One group of researchers refer to an adaptive cognitive and emotional toolbox we use in taking action: ways of making decisions that come from our biological past, a past in which survival depended on acting quickly on limited information. So we pay attention to environmental cues. We pay attention to what other people are doing. We pay attention to “gut feelings,” which is our history talking to us.
You no doubt have a health practitioner with whom you work—probably an MD. Is your trust in what he or she tells you based on your evaluation of his or her grasp of the relevant scientific literature? Or do you have the sense that he or she is a very nice person in whom you have a lot of confidence?
The last is what I consistently hear. Sounds unscientific. Oddly, scientists do somewhat the same thing. A recent study found that a wide range of biomarkers used in diagnosis and treatment have no statistically valid basis. As I’m sure you know, statistics is the bedrock of conventional health science and practice.
The explanation for this scientific dissonance isn’t the consequence of corruption. It is simply a matter of scientists and practitioners taking actions base on environmental cues, what other people do, and gut feelings.
What I did not just say is that the science is irrelevant. On the contrary, it is very relevant. But the science isn’t sufficient to fully inform the actions taken by civilians and experts. In particular, the science is not enough to explain why both civilians and practitioners pay so much attention to the biology, the inside of health and so little to the environment, the outside of health.
Consider a common sequence in how someone might become ill. She is exposed to a pathogen. She is infected. She becomes ill. If exposed, is she certain to be infected? No. If infected, is she certain to fall ill? No. Those each depend on the state of her immune system.
But wait. Exposure is environmental, not biological. It’s outside, not inside. And the state of her immune system is not a matter of genetic destiny. For example, someone struggling to make ends meet is under stress, which dampens her body’s immune response to pathogens.
What we have failed to do—individually and institutionally—is devote time and attention consistently to both our biology and our environment in our search for what is safest and most effective.