It is not simply the complexity and political pressure on decision makers that leads to problems of bad science advice. Let’s take a much simpler issue than climate policy where “expert” opinions dominate: Approval of drugs for human use.
As a matter of practice, today’s FDA requires 1) proof of safety and efficacy in animals, 2) a specific identified mechanism of action before even considering approval, and 3) clinical trials showing evidence of human efficacy superior to existing drugs. The FDA also 4) prohibits “off-label” marketing by owners of drug patents even if doctors and researchers are openly discussing the off-label benefits of a drug. Not one of these policies is easily justified on a “scientific” basis.
On 1), it’s often remarked that drugs that work well in animals fail in human trials; what is more insidious is that lots of drugs that fail in animal models might well be effective in humans (e.g. aspirin) but we will never know. In fact, it is a commonplace among workers in the pharma industry that aspirin could not be approved today, a sobering fact that by itself should tell us that the system has gone off the rails.
What expert science advisors will take responsibility for this state of affairs? Have they skewed their research to fit the needs of the politicians?
On 2), all drugs before the 1970s were approved without knowing exactly how they work. Of the drugs approved later with purported mechanisms, later research, when it has been performed, has often found that those mechanisms were either spurious or partial. (There is evolutionary reasoning to suppose that single-pathway, highly targeted drugs are less likely to be effective because biological organisms need to be robust to blockages or up-regulation of single pathways.) Therefore, many recent drugs were found to work and were approved based on a fictional theory of action. Yet new drugs are still expected to produce these fictions.
Is there a valid “consensus” that this procedure is defensible? Are the scientists simply being overwhelmed by politics?
On 3), asking each new drug to beat the existing standard rather than a placebo is counterproductive because any trial population aggregates hidden patient characteristics. A drug might beat placebo but not the existing standard drug in such an aggregate population while having superior performance or lower side effects on an unsuspected sub-population. If the drug were approved, doctors would be able to try it out on patients who responded poorly to the existing standard treatment, and so find, by trial and error, these sub-populations that benefit from the new drug. FDA rules prevent this form of progress. Instead, the drug company must try to predict in advance of the trial the sub-populations that will benefit most from the new drug and then set up the trial to include only those types of patients. But, given 2), that is not really doable most of the time. Humorously, if the drug were to be approved, doctors could still prescribe it “off-label” to whatever sub-population they wanted.
Whom should we blame for this outcome? The politicians? The public?
That leads to 4). Aside from the blatant First Amendment infringement entailed by FDA “off-label” marketing rules, we have the absurd spectacle that, for example, chemotherapy drugs are prescribed “off-label” the majority of the time because they are mixed and matched based on clinical experience and the odd academic (not FDA-submitted) clinical trial. We know with certainty in this case that the presumption that drugs should not be prescribed “off-label” is ridiculous; no responsible oncologist would harm her patients by restricting her treatments to those the FDA has approved. Yet the FDA shields its policy under the guise of insisting on “scientific evidence” and the silence of the lambs is pervasive.
Before we try to apply “science advice” to the hugely complex, socio-economic-geographic-political issue of trying to force the world off fossil fuels, we might first try to figure out why the “science advice” applied by technocrats to the much simpler issue of drug approval so patently contravenes widely known facts.
Hint: I don’t think you can just blame the politicians.
