On January 11, 2020 The New York Times (NYT) published an opinion piece by their Editorial Board: “The F.D.A. Is in Trouble. Here’s How to Fix It”. The F.D.A. is the US Food and Drug Administration, a regulatory body with gatekeeping powers over pharmaceutical markets. Since 1962, patients can access new medical treatments only after the F.D.A. has declared them safe and effective, on the basis of evidence gathered in clinical trials. This is a form of pharmaceutical paternalism: patients’ right to try whatever treatment they see fit is partially restricted – they will find in chemists only those drugs that the F.D.A. judge good for them. Yet, argues the NYT Editorial Board, “libertarian groups bent on deregulation at any cost” are exploiting the frustration of patients who don’t find any treatment option in the market to put pressure on the F.D.A., curtailing its “already diminished powers.” I think that the NYT is right to be concerned with this trend, and in a recent article, I provide an account of why exactly we should value pharmaceutical paternalism.
Let’s begin by considering what could thought wrong with the FDA’s remit. Several philosophers have recently put together a battery of arguments to show that patients would be better off without regulatory paternalism. What patients need is reliable information on the safety and efficacy of drugs so that they can decide on their own whether it is worth trying them. Jessica Flanigan contends that the F.D.A. should just provide that information without any gatekeeping prerogatives. Julian Reiss, more radically, defends that markets alone will deliver the necessary evidence. If, in a worst case scenario, patients feel they have been cheated, they can always litigate.
Libertarian arguments have some appeal. Who would not want to have the last word on what pharmaceutical risks to take? Yet, I argue, there is something that all but the staunchest libertarian should fear: the asymmetries of information that pervade pharmaceutical markets.
First, nobody (except chemists) can tell apart a legitimate and a fake treatment, and this provides a huge incentive for rogue manufacturers to flood markets with cheap counterfeit drugs that crowd out the real treatments. Economists call this adverse selection.
Second, gathering the necessary evidence to prove in court that a drug is defective is too costly for the average patient. After all, pharmaceutical companies spend millions of dollars to generate this evidence in long and expensive clinical trials, and they are rarely beaten in court.
Think, for instance of the class actions against the analgesic Vioxx, usually considered a success story about patients obtaining redress thanks from pharmaceutical companies. Indeed, Merck, the manufacturing company, reached a settlement compensating patients with $4.85 billion. Yet, Merck’s initial strategy was precisely not to settle, winning in 11 of the first 16 trials completed. Merck’s line of defence hinged on lack of evidence about Vioxx being the proximate cause of death. Jurors occasionally declared Merck guilty, perhaps moved by the claims of alleged corporate dishonesty (withholding information about cardiac risks). But after the first sixteen trials, it became clear for the plaintiffs that it was too difficult to show that Vioxx had actually caused the patients’ death against Merck’s legal and scientific firepower. The company then offered $4.85 billion settlement just to avoid further legal costs. The settlement imposed tight conditions on the plaintiffs –e.g. they had to accept it without a clear estimate of the compensation they would individually receive. If the number of plaintiffs had been smaller (around 50.000), Merck could have chosen to defeat them in court. When the evidence of harm is not sustained by big numbers, litigation may simply fail and impose serious costs for plaintiffs.
Given this huge asymmetries of information, I argue, it is better for patients to defer on an impartial regulatory agency to test treatments and, like Ulysses, tie themselves up to the mast of the agency’s verdict, consuming only approved drugs. Courts or markets provide no viable alternative for most patients to obtain redress from snake oil seller exploiting their uncertainty.
If patients are indeed frustrated with the lack of treatment options, compromising on safety is usually not a good solution. The F.D.A. has done an extraordinary job at keeping truly dangerous compounds outside pharmaceutical markets: less than 2% of the drugs approved by the F.D.A. between 1950 and 2011 have been withdrawn for a mistaken assessment of safety. Yet, according to the World Health Organization database, just in between 2000 and 2005, the United States contributed 953.919 adverse effects reports (or 537.6 reports per million inhabitants). In other words, even with drugs tested for safety and efficacy there is real uncertainty. Weakening the regulatory paternalism of the F.D.A. will make the uncertainty bigger and it will work no miracles for those who need a cure.