The rise and fall of therapeutic rationality

This ProPublica story—not just the spread of disinformation about these drugs, but specifically doctors’ complicity in generating runs and shortages, endangering patients who need them for chronic diseases such as lupus—reminds me of what the physician-historian Scott Podolsky calls a “pyrrhic victory” in the battle over “therapeutic rationality” in his wonderful book The Antibiotic Era: Reform, Resistance, and the Pursuit of a Rational Therapeutics—which anyone interested in the history or philosophy of medical evidence should go read immediately.

Podolsky shows that in the 1970s a powerful backlash from a coalition of doctors and pharmaceutical companies against the FDA’s new power to regulate drugs helped ensure we have no robust, centralized public oversight of prescription practices. (If you’re surprised to see doctors opposing what you think of as the public good, you’ll be even more surprised to read about their opposition to universal health insurance in Paul Starr’s The Social Transformation of American Medicine: The Rise of a Sovereign Profession and the Making of a Vast Industry.)

Here’s how Podolsky puts it:

The limits to government encroachment on the prescribing of antibiotics in the United States would be reached with Panalba and the fixed-dose combination antibiotics. While the FDA had been empowered to remove seemingly ‘irrational’ drugs from the marketplace, no one had been empowered to rein in the seemingly inappropriate prescribing of appropriate drugs. The 1970s would witness ongoing professional and government attention given to the increasingly quantified prevalence of ‘irrational’ antibiotic prescribing and its consequences, and such attention would in fact lead to attempts to restrain such prescribing through both educational and regulatory measures. The DESI process, though, had generated a vocal backlash against centralized attempts to further delimit individual antibiotic prescribing behavior in the United States, resulting in generally failed attempts to control prescribing at local, let alone regional or national, levels in the United States.

In the case of antibiotics, the result has been decades of promiscuous prescription, as overuse of antibacterials helped to breed a new generation of antibiotic-resistant “superbugs”—at the very same time that pharmaceutical companies, deciding that these drugs weren’t profitable, stopped trying to develop new ones. We thus have very few antibiotics to take the place of the ones that no longer work, even though isolated voices have been sounding the alarm all along—just as others have regarding pandemics. (Obama’s administration not only put in place a pandemic response team that Trump’s administration dismantled. It also developed a “National Action Plan for Combating Antibiotic-Resistance Bacteria.”) This is maybe the least familiar massive negative market externality of our time. Another result of such promiscuous prescription is much better known: we call it the opioid crisis.

However you view the FDA today—emblem of consumer protection or bureaucratic mismanagement, regulatory capture or government barrier to innovation, success story or failure—there is no question that public oversight of drugs is important and that it is high time to rethink how we regulate prescriptions, too.