Developments this week highlight the problems with the neoliberal decision to privatize medicine in the U.S. Certainly the Affordable Care Act (ACA), which entrenches responsibility for access to healthcare to private insurance companies and then attempts to contrive a market for patients to shop between insurance plans as some sort of proxy for shopping for doctors, is the most famous recent example of this decision. Never mind that in market terms medicine is a classic credence good: you may not know either before or after purchase whether you are getting a good deal, and the barriers to knowing this are nearly insuperable owing to the inherent complexity of medicine and the inherent uncertainty behind most medical judgment, even perfectly executed by brilliant practitioners. Medical care just isn’t one of those things that works well as a market good.
Meantime, this week, President Obama signed the 21st Century Cures Act. This bipartisan bill makes an enormous investment in research into urgent health problems from Alzheimer’s, to opiate addition, to cancer, and continues to fund the promising developments in “precision medicine.” This is an obvious good. What could be wrong? The tradeoff, beyond the now stale point that there is no investment in the social determinants of health – like urban infrastructure – is that it loosens regulatory requirements for drug approval even further. As the Washington Post reports:
“To accelerate the development of new cures, the bill contains more controversial elements. The drug industry has argued that regulatory bottlenecks slow down the development of new medicines. To address that problem, the bill pushes for the use of new kinds of “real world evidence” to support some drug approvals, allows antibiotics makers to test their drugs in limited populations of patients and creates an expedited pathway for approving regenerative medicine”
This is not to say that in the real world, where legislation is necessarily imperfect, that the 21st Century Cures Act is a bad thing overall. Funding for everything it tackles is vitally important. But these are among several potentially troubling provisions. “Real world evidence,” for example, essentially means “empirical and observational clinical results,” and mainly not evidence from clinical trials - which eliminate much wasteful spending on miracle cures that turn out not to outperform placebos, or to have serious side-effects.
All of that matters because we are dealing with public health emergencies induced by too-quick regulatory approval already. There are smaller ones, like the absolute debacle that is Medtronic’s Infuse. There are larger ones, too: Vioxx may have cost nearly 40,000 Americans their lives due to too-rapid regulatory approval, and potential complicity within the FDA. This is something the U.S. used to get right: the epidemic in catastrophic birth defects in Europe due to Thalidomide was avoided in the U.S. because of slower regulatory approvals.
Let’s consider the current opioid epidemic, which killed 30,000 people in 2015 alone, now accounting for more fatalities than gun deaths for the first time. Yet doctors continue routinely to overprescribe the painkillers. Addicted patients whose prescriptions are cut, presumably for their own interest, often find themselves in a morass of illegally-obtained opiates and heroin. Neonatal abstinence syndrome has risen six fold in the last decade, particularly in rural areas. Why? Part of the problem is federally-mandated patient satisfaction surveys, which pretend to solve the credence goods problem by treating medical care like television repairs and asking patients if doctors aggressively treated their pain. But there are much deeper problems.
Opioids are big, big business, with all the corruption that entails. In June, several drug salesmen were arrested for paying doctors to prescribe fentanyl, the drug that killed Prince. One assumes that this problem follows the colloquial logic of cockroaches: for every one you see, there are forty you don’t. In the meantime, pain doctors complain that insurance companies refuse to cover more expensive, but much safer, methods for dealing with chronic pain. Opioid addiction thus becomes an economic necessity for many patients. Drug approvals are a problem as well: OxyContin was approved on the premise that it lasted twelve hours, and that therefore two pills a day were sufficient. Internal documents and sealed court records showed that the company knew perfectly well that the pills did not last this long for many patients, and rather than advocating more frequent doses (undercutting the pill’s price advantage), Purdue recommended higher dosages, increasing the risk for problems with addiction. This problem occurred after Purdue paid a $600 million fine for misleading the public about the addictive nature of its product. Furthermore, there is mounting evidence that opioids don’t even effectively treat chronic pain, even as they risk not just addiction but other serious side-effects, like cardiac problems (see here, here, and here for a start).
And then, a report issued in September discovered that the makers of prescription opioids had adopted a 50-state lobbying and obstruction strategy designed to block restrictive legislation: “the Associated Press and the Center for Public Integrity found that they often employ a statehouse playbook of delay and defend that includes funding advocacy groups that use the veneer of independence to fight limits on their drugs, such as OxyContin, Vicodin and fentanyl,” additionally spending over $880 million on lobbying and campaign contributions from 2006-15 – 200 times more than those advocating for stricter policies and even eight times more than the gun lobby over the same period.
Yay markets! Yes, let’s do spend money on research. But maybe not so much on the further deregulation of the drug approval process.