Someone has to be the first one. The reality is every prescription or over-the-counter medication that we use today would not be available if someone had not been the first one. How do you decide who goes first? Should it be the terminal patient who has the least to lose if something should go horribly wrong? Or maybe you should pick the healthiest patient so you know any side effects are from the drug and not something else? Rather than playing this grim utilitarian game, the point of clinical trials is to mitigate the risks of being the first. Once sufficient trials have been conducted in animal studies, a drug can move on to a phase I clinical trial. This trial merely tests for safety. Phase II trials test for efficacy. Phase I usually has thirty-to-fifty people, while phase II may have one hundred-to-two hundred people. Phase III trials are with 1,000 to 3,000 people. It is a large-scale check of the drug’s effectiveness, side effects, and comparison to other drugs on the market.
In theory, modern-day clinical trials are carefully regulated, and patients who volunteer for the clinical trial are adequately informed and compensated. The idea is to protect the patient while also ensuring that the new drug is safe and effective. However, there is a dark underside to clinical trials. Historical examples are the Tuskegee syphilis case and the Willowbrook hepatitis study in which vulnerable people were exploited for a clinical trial. In the 1990s, the case of Jesse Gelsinger caused the entire field of genetic therapy to come to a halt when he died a horrific death as a result of undergoing a trial procedure. His parents argued that they and Jesse were not adequately informed of the risks.
Two articles published on Medium.com look at problems with the modern-day clinical trial system. The key difference between today’s clinical trials and yesterday’s is that many trials are conducted by independent, for-profit companies hired by the drug company, rather than trials conducted at publically-funded research universities and medical schools. Additionally, institutional review boards for these groups are independent, for-hire groups, which presents a potential conflict of interest.
The first article, “The Best-Selling, Billion-Dollar Pills Tested on Homeless People” by Carl Elliott, author of Better than Well: American Medicine Meets the American Dream, begins by taking the reader to a homeless shelter in Philadelphia where Elliott interviewed several people who had done, or were currently involved in, a clinical trial. Many of them were involved in trials for antipsychotic drugs.
Antipsychotic drugs are a hot-market item, garnering revenues in the billions of dollars, but they are difficult to test because they tend to have potent side effects. One way some companies try to deal with this is to target the homeless population. Mental illness is prevalent among the homeless, and homeless people tend to be desperate for money. Many of them are willing to risk the side effects for the meals, money, and facilities that an inpatient clinical trial offers.
Elliott’s article provides an eye-opening look into an industry that may be following the letter of the law, but is profiting from a particular population’s desperation. Furthermore, it is unclear from his interviews whether all of the patients were competent enough to provide informed consent, either because of mental illness or because the prospect of making money blinded their judgment.
The second article by Peter Aldhous entitled “Why Are Dope-Addicted Disgraced Doctors Running Our Drug Trials?” discusses the kinds of doctors that are hired by these privately operated clinical trial companies. Many of these doctors are defunct clinical doctors who will often have a record of negligence, drug abuse, or malpractice. Rather than hiring astute doctors who would be able to deal with any number of unexpected ailments that could arise from new drugs, these companies are hiring doctors that cannot find a job anywhere else.
Certainly, not all clinical trials are as nefarious as the ones that Elliott and Aldhous investigated. However, their articles bring to light a problem with the system that has emerged in last ten-to-fifteen years in which private firms conduct trials rather than university research institutions.
Aldhous summarizes that, “[a]fter spending months in the world of clinical trials, I’m left with an impression of a system that has evolved beyond the FDA’s ability to manage it. I’ve also been struck by the profound disconnect between the disciplinary system that governs everyday medicine, and the separate regulations meant to protect clinical trial volunteers.” Additionally, he points out that the industry seems to prioritize speed and efficiency, two characteristics that have typically not been the hallmarks of the clinical trial process.
These articles are worth a read. They bring to light several ethical issues in the current clinical trial system and address key bioethics concepts, such as informed consent, experimenting on vulnerable populations, and research ethics.