June 09, 2018
It’s well-known that intellectuals have a hard time dealing with new ideas. And, for better or worse, the NYT’s editorial writers are intellectuals.
This made it painful to read its editorial criticizing the Food and Drug Administration’s (FDA) efforts to hasten the approval of new drugs. The piece makes many important points about the problems with an accelerated drug approval process. This increases the risk that drugs will be approved that are of little benefit and possibly even harmful.
While it notes the inevitable tradeoff between the desire to quickly make new drugs available to patients who can be helped and ensuring their safety and effectiveness, it misses the fundamental problem with having the testing done by a company with a financial interest in pushing drugs whether or not they are safe and effective.
This is an especially serious problem given the enormous asymmetry in the information available to the drug company doing the testing and both the FDA and the larger community of researchers. The decision to conceal or misrepresent test results has proven enormously harmful to the public in recent decades, most notably in reference to evidence that the new generation of opioid drugs are addictive.
The obvious solution to this problem would have the government take responsibility for funding clinical testing. The government could still contract out the testing process, but if it took possession of all rights to the drugs, so that they would be available as generics when they were approved, there would be no one with an interest in misrepresenting the research results. (This would not preclude drug companies for paying for their own tests on drugs to which they maintained patent monopolies, but these drugs would be subject to much greater scrutiny for approval. They would also face the risk of competing with drugs that are every bit as effective selling at generic prices.)
While publicly funded drug testing would seem an obvious way to deal with a serious health issue, it would require the sort of new thinking that intellectuals find very difficult.
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