Testing Freedom

FDA paternalism blocks our path to a more innovative, personalized and abundant health system

By Alex Tabarrok

The world is awash in data. Data abundance and tools to extract meaning from data let us better understand, control and improve our world. From the outer reaches of space to atoms and quarks, we are learning more at ever-finer levels of detail about the universe. Perhaps nowhere is this exploration more important than learning about the functioning of our own bodies.

These days, data about ourselves and our health comes to us in ways we couldn’t have imagined just a few decades ago, and this can bring about a golden age of personalized medicine that could revolutionize healthcare and help us live longer and healthier lives, which is what an abundant health system is all about. That is, if we can tear down some of the red tape that holds back a fuller realization of that abundant health system.

The Potential of Personalized Medicine

At-home testing—DNA testing, for example—is one of those personalized medicine advances that would have been unthinkable not too long ago. These tests provide treasure troves of new data about ourselves: DNA tests can tell us about our ancestry, which diseases we may be especially prone to, and which drugs might work especially well or poorly for each of us.

Personalized medicine can adjust medications not only to DNA, which is unchanging, but also to the dynamic response of RNA, proteins and metabolites. One study describes how a patient was treated via a “personal omics profile (iPOP), an analysis that combines genomic, transcriptomic, proteomic, metabolomic, and autoantibody profiles from a single individual over a 14-month period.” Studies like this point to a future in which we will be able to measure a disease or an infection and a body’s response across many different variables in close to real time. A personal omics profile could thus optimize healthcare strategies not just to a particular person but to a particular person at a particular time and place.

And we do have a history of making use of some aspects of personalized medicine in the United States. While the most advanced tests and devices are not yet integrated with the medical mainstream, pregnancy tests and AIDS tests have been common for years. The recent COVID pandemic also illustrated the value of real-time, at-home tests for viral antigens. Popular wearables like Fitbit are relatively simple medical devices that provide real-time measurements for things such as blood oxygen levels, skin temperature and heart rate. Much more will be possible as sensors become cheaper, more refined and more integrated with our bodies.

The Slow History of At-Home Tests

Personalized medicine, however, has advanced at a far slower rate than the underlying data and technology. U.S. Food and Drug Administration (FDA) regulation has slowed adoption and increased costs for tests and devices that inform patients about their own bodies. In fact, the FDA has a long-standing fear and antipathy toward personalized medical tests.

In 1972, the FDA confiscated thousands of home pregnancy tests, declaring that they were “drugs” meant to diagnose a “disease” and thus fell under the FDA’s regulatory dominion. The case went to the U.S. District Court for the District of New Jersey, and Judge Vincent P. Biunno ruled that the FDA had overstepped. “Pregnancy,” he said, “is a normal physiological function of all mammals and cannot be considered a disease … a test for pregnancy, then, is not a test for the diagnosis of disease. It is no more than a test for news….” As a result of Judge Biunno’s ruling, home pregnancy tests are easily available today from pharmacies, grocery stores and online shops without a prescription.

These days, debates over home pregnancy tests from the 1970s seem anachronistic and paternalistic. Yet the same paternalistic arguments appear again and again with every new testing technology. In the late 1980s, for example, the FDA simply declared that it would not approve at-home HIV tests, regardless of their safety or efficacy. As with pregnancy tests, the concern was that people could not be trusted with information about their own bodies.

Testifying at an FDA hearing, Charles McCarthy of the National Institutes of Health argued that without professional oversight, “people who test positive or even falsely positive for HIV may react in hysterical or irrational ways, such as committing suicide, while those who test falsely negative may wrongly consider themselves ‘resistant’ to the deadly virus and continue high-risk behaviors.” While the first rapid at-home HIV test was developed and submitted to the FDA in 1987, it took 25 years before the FDA would approve these tests. (Now, you can easily buy such a test on Amazon.)

The FDA used the same paternalistic arguments to suppress genetic tests. In 2010, the director of the FDA’s Center for Device and Radiological Health argued that direct-to-consumer genetic tests are risky because “a patient may make a decision that adversely affects their health, such as stopping or changing the dose of a medication or continuing an unhealthy lifestyle, without the intervention of a learned intermediary.” Since that time, the FDA has only grudgingly approved a small handful of the genetic tests that could be useful to consumers.

The most consequential failure of the FDA to allow consumers freedom of information was the delay in approving rapid antigen tests for COVID. Rapid antigen tests tell a consumer whether their body has enough virus to be infectious to others. When used widely, these tests can reduce the spread of COVID. Had these tests been available sooner, many lives might have been saved. But these tests only became available in the United States as the pandemic was slowing because the FDA regarded them as too risky for consumers and did not prioritize their approval.

Rapid antigen tests similar to those used for COVID could also be used to diagnose other viral diseases such as influenza. In addition to helping people decide when to stay home and prevent contagion, such tests could also allow for more accurate treatment and reduce the overuse of antibiotics. Nevertheless, even though these tests have long been technologically possible, there are no approved at-home flu tests in the United States. In Germany, in contrast, rapid at-home combination COVID, flu and RSV tests are readily available.

The FDA versus the First Amendment

The FDA has a vital role in ensuring that tests are clinically accurate—tests should do what they say they do. Tests don’t need to be perfectly accurate to be useful (think of thermometers, personality tests and tire pressure gauges), but if a test advertises that it measures HDL cholesterol, it should do that within the tolerances the firm promises. The FDA has the technical knowledge to ensure that tests work, and that’s a skill that Americans value from the agency.

What Americans don’t want is to be told they can’t handle the truth. Yet when it came to at-home tests such as pregnancy tests, HIV tests and genetic tests, that’s exactly the reasoning the FDA used—and continues to use—to suppress information. The FDA should ensure that tests are safe, but “safety” means physical safety. The FDA may not declare a product unsafe because it might produce dangerous knowledge. Patients have a right to know about their own bodies. Our antibodies, ourselves. The FDA has authority over drugs and devices but not over patients.

Judge Biunno had it right back in 1972 when he said that diagnostic tests produce “news.” Test results, therefore, are a type of speech that fall under the First Amendment right to freedom of speech. The Supreme Court has repeatedly rejected restrictions on freedom of speech based on “a fear that people would make bad decisions if given truthful information”; thus, FDA restrictions on tests based on such fears are unconstitutional. The question of whether consumers will respond “safely” to test results is no more relevant to the FDA’s regulatory authority than the question of whether readers will respond safely to political news published in The New York Times. The FDA does not have the constitutional authority to regulate news.

We Have a Right To Know

New tests and devices will let us learn about the functioning of our own bodies and minds at an unprecedented level of detail. From better learning will come better treatments, and then better modifications and improvements. Personalized medicine will become personalized body and mind management. The future of personalized body and mind management, however, requires that the FDA be transformed from a paternalistic agency that tells consumers what they can and cannot know about their own bodies to a science-based adviser that helps people to learn about themselves for themselves.

Everyone has a right to learn what’s going on in their own bodies—and the FDA has no remit to control the news, including news about how our bodies are functioning. The FDA cannot forbid Americans access to news based on concerns that people might make poor decisions if they know the truth. Data abundance must be coupled with free speech to help bring about the abundant health system we seek.