Clinical trials need a multilateral effort

Failed HIV-prevention drugs in Africa question ethics of drug trials in developing countries.

Anant Naik

For many years, medical advancements have faced a myriad of moral dilemmas. Perhaps one of the most important ones is the ethicality of human trials — not that they happen at all, but rather how they happen, who the subjects are and whether they’re in accordance with an appropriate timeline. Recently, a large clinical study testing new HIV-prevention methods throughout Africa failed.

The study found that people who took the new medication were just as likely to get HIV as individuals in the controlled placebo group. However, many researchers cited the fact that they were paying their participants as the reason why the study failed. Because researchers were paying their participants, the participants were more likely to lie about having partners with HIV.

Now, clinical trial failures aren’t hard to fathom — failure is one of the challenges of medicine. Running experiments and verifying that drugs work is all part of the scientific process.

However, it seems to me that ill people living in developing countries become the first targets for large studies that involve experimental procedures. In the United States, the Food and Drug Administration manages a long list of regulations to control how clinical trials are run. Oftentimes in developing countries, no such regulatory body exists.

It’s no secret that many developing countries across the world don’t have developed systems to treat diseases. As a result, external actors like pharmaceutical companies claiming to be capable of solving some of their problems can often lead to exploitation.

There needs to be an international forum to partner with national regulation organizations like the FDA. This forum should regulate trials, ensuring that they have reached the stage at which a clinical trial becomes absolutely necessary.

Although experimental drugs sometimes appear to succeed, many do not. The purported treatment for Ebola did not. In fact, many companies’ studies on the efficacy of the experimental Ebola treatment have refused to give any data to its effectiveness. Creating this governing body isn’t out of the capacity for the international community. If the U.S. were to help create one, there’s now a good window of opportunity to do so.

Recently, FDA commissioner Margaret Hamburg stepped down after six years of service. Hamburg’s supporters have argued that she oversaw many positive changes to U.S. medical policy, including faster pre-market evaluations of biomedical devices and drugs. However, her critics argued that she sacrificed safety for the sake of passing treatments that were often premature and relatively untested.

I’m hoping that the next FDA administration undoes some of these reforms, increasing its regulations of clinical trials and experimental drugs. Science is slow for good reason.

We experiment again and again to make sure we don’t cause harm in the future. Though we recognize that failure is a part of the process, we also make sure that all of our efforts are directed to minimizing failure. Hopefully, the new FDA commissioner will see that this is done in the future.