The Invisible Graveyard

Art by Evan Martinez

American law has long recognized the role of negligence in criminal proceedings. Determining guilt in the case of malicious action is straightforward enough—if a person acted with intent to do harm, they ought to be held responsible. But the justice system accepts that cases of inaction can be just as fatal. A person does not need to hold the knife to be held liable; the simple failure to act when there is known risk that apathy will lead to harm—take, for example, failure to feed a child—is enough to establish guilt. In the eyes of the law, death that can be easily prevented—yet is not—is just as immoral.

But what if the negligence is committed not by a feckless father or a dilatory doctor, but by an entire institution? What is to become of a body whose indifference to human suffering leads to the agony of not a single person or group, but untold thousands? With luck, that agency will be punished with an excruciating $372 million increase in its annual budget. Such is the story of America’s Food and Drug Administration (FDA). 

A byproduct of the early days of the Progressive Era, the FDA was ostensibly created to protect consumers. Operating under the reasonable assumption that drug companies know more about the intricacies of pharmacology than the average man-on-the-street, reformers sought a neutral arbitrator to protect ignorant buyers from snakeoil salesmen. But rather than establish a merely consultory body, a glorified Consumer’s Report, Congress gave this new authority the power to prohibit the sale of all medicine it did not explicitly approve.

This decision has been a disaster for the well-being of Americans ever since. Far from an enlightened technocracy, the FDA is and always will be run by mere mortals, prone to the same incentives and biases as everyone else. It has cultivated an internal culture of excessive caution born from the confines of its position in the public sphere at great cost to public health. Hundreds of thousands of easily preventable deaths have occurred under the FDA’s watch, and thousands more will die so long as it exists. 

Careless Caution

The FDA is, by design, a deeply conservative institution in the most literal sense. The agency’s express reason for being is to slow the distribution of new pharmaceuticals, to stand athwart medical progress yelling ‘Stop!’ Some of this aversion is, of course, warranted. Unlike most other goods—say, a new brand of cereal or perfume—consumption of a new, untested type of therapeutics can result not just in a loss of income for the buyer, but catastrophic health consequences. 

The infamous tale of thalidomide illustrates this point best. First developed in the 1950s to treat pregnant women’s morning sickness, consumption of thalidomide was soon linked to grotesque fetal deformities. Children of those who had taken thalidomide were born without arms or legs, and most were afflicted with an array of heart, eye, and brain disfigurements. Within five years of its initial release the drug was pulled off the shelves, but by then the damage had already been done. An estimated 10,000 babies across 49 countries were stricken by the drug’s effects, half of whom died mere months after birth. But notably absent among the afflicted countries was the United States. Not convinced of the drug’s safety, the FDA initially blocked the distribution of thalidomide, saving countless thousands of families from the unspeakable pain of having to bury their child. 

The FDA deserves praise for this rare instance of clarity, but it should be recognized that the blockage of thalidomide was not due to the wisdom of the Administration. Nearly all drugs that come before the FDA are sent for further testing. A 2011 study found that a grand total of 9% of pharmaceutical applications are approved in the first round. The institution’s success in preventing the sale of thalidomide is akin to firing randomly into a crowd and accidently hitting a known terrorist—a laudable consequence, if through less than ideal means. 

The FDA has good reason to be cautious in its approval process, as anything less can land the bureau in hot water. Regulatory agencies are often imagined as drab, boring entities concerned only with facts, free from having to deal with public opinion. But this understanding is simply false. Like all organizations, the FDA is composed of people, each of whom are concerned with themselves and how they are perceived. Its leaders have ambitions and its employees' morale. The FDA itself has goals—chief among them the continued maintenance of the FDA. 

It is for this reason that agencies like the FDA have tremendous institutional incentive to act with extreme caution. Should it make a judgment in error and give license to an unsafe drug, as it did in 1976 when a new vaccine against swine flu led to cases of paralysis, the costs to the agency are large and immediate. If it acts with too light a touch and approves a drug that ultimately kills 100 people, it can expect to be dragged over the coals every which way. Its Commissioner will be called to testify in front of Congress, its Washington DC office pestered by bereaving families, the obituaries of the dead plastered over every news outlet, and legislators eager for a popularity boost will grandstand on the promise to reform the FDA so that such a tragedy will never happen again. 

If, however, the FDA decides to take its time in approving new medicines, the cost to them is near zero. Should they insist an otherwise promising pharmaceutical endure an extra five years of study on the off chance that internal tests were in any way flawed, few outside its halls will know. Drug companies will grumble, and perhaps a few medical journals will protest the decision, but there will be no mass backlash nor government inquiries. Most will instead chalk it up to the routine activities of a regulator, as it must clearly mean there was something wrong. 

Zero cost to regulators does not mean zero cost to society. Just as there is benefit to preventing harmful drugs from being sold, there is a cost to preventing the sale of safe drugs—and it too is denominated in human lives. Time delays in approval can mean the difference between life and death for the critically ill. A recent hearing over the potential approval of Amylyx, meant to ease the suffering and extend the life expectancy of those with ALS, insisted on an additional four years of study despite the average life expectancy of patients ranging 2-5 years. Despite evidence from Europe regarding the safety and efficacy of beta-blockers, which are used to prevent heart attacks, their sale was briefly halted in the United States over their potential to cause cancer. When sales resumed five years later, the FDA proudly announced it could save 17,000 lives a year, unwittingly admitting their initial moratorium caused ~100,000 needless deaths. 

In what is quite possibly the most poignant example of Fredric Bastiat’s principle of the seen against the unseen, these dead will not be remembered. Their names will not be plastered over newspapers nor will their story be used to lobby for change. Rather than the hundreds who are seen, those thousands of unseen deaths will be attributed to the uncaring cruelty of the universe rather than an unjust system. These dead remain faceless and nameless, unceremoniously cast aside into the invisible graveyard. 

Incentives matter. At no point was it written into law that the Food and Drug Administration should pursue such a timid approach to approvals; rather, it was a tendency that emerged naturally. No one wants to look bad and no one wants to be chastised, and in the absence of good reason to act otherwise, why should anyone, let alone a multi-billion dollar institution, feel compelled to change? In the words of former FDA Commissioner Alexander Schmidt: “In all of the FDA’s history, I am unable to find a single instance where a congressional committee investigated the failure of FDA to approve a new drug. But, the times when hearings have been held to criticize our approval of new drugs have been so frequent that we aren’t able to count them. The message to staff could not be clearer.” Possible reforms to expedite approvals—such as increasing funding when approval rates increase—undermine the entire point of the authority. 

The FDA cannot be reformed—it can only be abolished. 

A Toast to Tort

FDA or otherwise, there remains the reality of asymmetric information between buyers and sellers of medicine that could lead to adverse outcomes. Most consumers have little clue what is held within their medicine cabinet and, if asked, would avoid any tablet containing dihydrogen monoxide while unthinkingly buying one made of butane. Without a disinterested intermediary, how, then, are patrons expected to make informed decisions? 

The simple answer is that they do not need to know much about anything. The beauty of the American legal system is the ease with which any one person can bring charges against those who abuse their imbalance of power. The unjustly maligned plaintiff of the infamous McDonald’s coffee incident, which saw a woman’s legs fuse together after she spilled coffee brewed at 190°F over her lap, received over $3 million in damages and caused McDonald’s to permanently lower its brewing temperature. After a minor crash led to the death of a driver of a Ford Pinto, in 1981 a California jury ordered Ford Motor Company to pay out the inflation-adjusted equivalent of $420 million in punitive fines and prompted the recall of over a quarter million cars. Rather than attempt the impossible and force unethical companies to behave morally, the American system allows businesses to behave as unscrupulous as they please on the condition that they are to be held liable for any damages their actions may cause. 

There is little reason to expect that this principle cannot be expanded further into the realm of pharmaceuticals. It does not even need to be limited to those who manufacture drugs; lawsuits can be expanded to all those along the distribution chain. Rite Aid’s recent bankruptcy is owed in large part due to its willingness to sell opioids to those with fake prescriptions. 

Just as in every other sector, the possibility of tort lawsuits acting as a freer, more nimble regulator of behavior than any one regulatory agency can provide the same assurances of quality without having to consider the internal interests of the agency. The purpose of any company, pharmaceutical or otherwise, is to make money. Jeopardize that and you can whip even the most nakedly evil firm into a cheerleader for consumer rights.