Recently we shared an article on drug trials in Puerto Rico. The point that the article was making was this: too many drugs are tested on a very narrow population, and this can lead to unexpected negative outcomes for people in underrepresented groups who take these medications. Puerto Rico’s high levels of ethnic diversity mean that drug trials taking place in Puerto Rico can more easily include a variety of individuals. This benefit of conducting drug trials can have economic value for Puerto Rico, which already has strong involvement with pharmaceuticals, medical devices, and biomedical research.

One reader suggested that we should tell people about the Puerto Rico drug trials involving birth control pills. We have not written about this episode in history before because it is not obviously connected with Puerto Rico’s political status. Since anti-statehood factions point to Puerto Rico’s economic woes as an argument against statehood, we like to point to the signs of economic improvement. However,  if that economic improvement is a question of exploitation, that would be a different message. So we are bringing you both sides of the question.

What are drug trials?

As medications and medical devices are developed, they are tested in a variety of ways. Before they can be approved by the Food and Drug Administration,  they have to be tested on fairly large numbers of human beings. This is essential to make sure that the medications are safe and effective before they are approved for human use. Without these trials, new medical technologies would have to be released without assurance that they are generally safe and without understandings of the kind of side effects they might have.

Clinical trials involve volunteers who try out a medication or medical device that has been tested for safety as thoroughly as possible without human subjects. These studies usually take place in different places around the world over a long period of time. The volunteers may have the advantage of testing new treatments before they are widely available, but they are also doing their part for advancements in medical research.

There have been many scandals in the past when medical treatments were tried out on people without their knowledge and consent. Now the laws and regulations about clinical trials are very strict, to make sure that these kinds of events never happen again.

The Puerto Rico pill trials

Birth control pills have made an enormous difference in the lives of people all over the world. However, when they were being developed in the 20th century, many people disapproved of birth control. The developers of the oral contraceptive had a hard time setting up clinical trials in their local communities.

At the same time, Puerto Rico faced overpopulation. The government made birth control legal in 1937, and encouraged women to have smaller families. Sterilization procedures were subsidized by the government and sometimes performed without the full understanding and consent of the patients.

Clinical trials of birth control pills began in Puerto Rico in the 1950s. The researchers have been accused of conducting the trials improperly. The women in the trials were not told that they were taking an experimental drug for a clinical trial. They were not told about the side effects that had already been noticed in trials conducted in Boston. They were given little safety information and those who complained about side effects were largely ignored and described as “unreliable.” Three of the women in the trials died, and their deaths were not investigated.

Reading about the history of the birth control pill, it is hard to overlook the attitudes of the times. Did the trials themselves amount to exploitation, or were they just handled badly, like so many other clinical trials at the same time in other places?

Women living in poverty in Puerto Rico were happy to try an alternative to sterilization. Puerto Rico already had a strong network of birth control clinics and no laws against contraception. The choice of Puerto Rico as a site for the clinical trials could have been simply a practical choice. However, it could also reflect a lower valuation of the lives of people in the territory. Complaints about side effects of medication from women in those days were often dismissed as exaggeration or emotional reactions, wherever those women lived, but some reports from the time claim that researchers believed Puerto Rican women were especially emotional.

Like the equally notorious Tuskegee study, the Puerto Rico pill trials are a bad mark on the history of the United States.

Modern clinical trials

Modern clinical trials conducted according to the strict laws and ethics now in place are a completely different thing. The clinical trials being conducted in Puerto Rico follow the same rules as those conducted elsewhere in the United States.

Puerto Rico exports more pharmaceuticals than any state and is in a strong position for biomedical research. Economically, this is an effort which plays to Puerto Rico’s strengths. It is essential to make sure that clinical trials conducted in Puerto Rico are regulated just as those in other places are. With that in mind, clinical trials can be part of the growth of the health care industry on the Island.

Statehood will provide a level playing field for Puerto Rico. With equality and justice and the full protection of the U.S. Constitution, Puerto Rico will be able to reach her full potential. Health sciences can be part of that.



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