Latino immigrants who earn a living by enrolling in clinical trials find themselves in a system ‘ripe for abuse’
When I arrived in the United States from Cuba in 2016, I needed a job urgently. An acquaintance of mine who had just bought a car with his earnings as a serial participant in phase 1 clinical trials — the stage in which side effects are tested for — urged me to join him in his career as a professional guinea pig. He said that he could earn thousands of dollars in a week.
It was tempting, so I went to the clinic he recommended: Watson Therapeutics, in Miramar, Florida. I filled out a form with my contact information. They never called me. I was probably lucky.
However, that trip was not a waste of time. It was the seed of a journalistic journey that led to a five-month investigation. The story focused on how Latino immigrants in financial distress volunteer as serial participants in private clinical drug trials, but they are not always informed about all the risks involved, and when something goes wrong, finding justice is agonizing.
With the support of the Dennis A. Hunt Fund for Health Journalism, Noticias Telemundo published “Salud de Alquiler” (“Health for Rent”) in June 2022, a five-part Spanish multimedia series that was also published in English by Telemundo’s sister site, NBC News.
The investigation spanned four states and Puerto Rico. I was able to tell dramatic stories of Latinos who have risked their lives for money in a system described as “ripe for abuse” by Olveen Carrasquillo, chief of general medicine at the University of Miami. Some of those stories include:
Maria Elisa Rangel, a 38-year-old undocumented Mexican immigrant who died in 2015 in Phoenix, Arizona, after participating in a phase I trial for an antiepileptic drug. The clinic, Celerion, and the pharma company, SK Life Science Inc., did not include in the informed consent an explicit mention of the risk of contracting a life-threatening syndrome. Her family sued both companies in 2016 and faced a David vs. Goliath battle to find out what had happened to the mother of four and seek justice. Both companies settled the case in 2022, after denying several interview requests made by Noticias Telemundo.
A Cuban immigrant who said that she stayed at a phase 1 unit currently owned by Quotient Sciences in Miami, Florida, where she claimed to have been coerced into taking an experimental medication in a higher dose than the one explained in the consent agreement. After she complained, she said that she was punished by not being allowed to participate in other trials for a year.
A Mexican immigrant in Texas who lost her hair after enrolling in three trials at once to maximize her earnings, taking advantage of the lack of mechanisms for clinics to detect “washout” violations.
My Cuban acquaintance, Roberto Lamelo, who recently lost two teeth and currently suffers from chronic diarrhea after participating in medical trials for years. There is no registry or database to help him find out whether his current health problems are connected with studies done in the past.
Those and other cases led to eye-opening findings that can be used as a resource to shape policy around the industry of private clinical trials. Some of those findings include:
Phase 1 private clinics often enroll the same Latino immigrants repeatedly, even though the long-term effects of recurring experimentation on human beings is not known.
Hispanics and other minorities who earn a living participating in private clinical trials mainly do so during phase 1. This suggests they are more willing to ingest experimental drugs that could make them sick, rather than participating in later-phase trials, when there’s hope that a drug that’s being tested may offer health benefits.
The states with the largest Hispanic populations — California, Florida and Texas — are the ones where most of these trials are conducted.
Before starting a trial, participants must agree to report on any side effects. Many said they sometimes hide adverse effects such as chronic diarrhea for fear of being withdrawn from the trials and not getting the full payment. This puts individual and public health at risk, several experts pointed out, as it tarnishes the data the Food and Drug Administration uses to approve or disqualify new treatments.
Legal immigration status is not required to participate in these trials, so many Hispanics who volunteer are immigrants, including some who are undocumented.
Participants must wait 30 days from one trial to the next, but some violate this protocol to earn more money. There is currently no regulatory mechanism at the national level to detect and prevent violations of the required interval between trials.
The high demand of Latinos interested in earning money through paid clinical trials has led to reports of attempted bribery. Some claim that clinic employees have asked them for money to guarantee them a place in the studies.
Those who enroll in clinical trials in the U.S. are not required to have health insurance, and clinics do not offer one either. Noticias Telemundo found that when undocumented volunteers require emergency medical care after a trial, drug companies and clinics can let taxpayer-funded programs, such as Medicaid, bear the expenses.
The system, as many experts pointed out during our investigation, has many problems and needs more regulation. And journalism is essential in pushing for policy change.
One lesson that may prove valuable for reporters contemplating a similar investigation is to build strong relationships with trial participants: Many of the findings will come from them, as private clinics and pharma companies — in our experience — are protective of their data. (For instance, a request for information sent to 50 of the most active phase 1 trial units in the country was not responded to by more than a half. Additionally, all clinics and pharma companies that we reached out refused to sit down for interviews).
As Alan Milstein, a personal injury attorney said, “The corporations conducting these trials don’t want people fishing around in their documents because, frequently, these reflect that they have not exactly conducted themselves in accordance with the regulations."
Sources and whistleblowers are not found in the Yellow Pages and creativity is essential to finding them and getting them to speak on the record. This was one of the toughest parts of reporting for our project. Serial participants refer to the clinics as their “workplace” and are often afraid to come forward on the record after experiencing what they describe as abuse or coercion, especially if they don’t have papers. Many do not even know how to identify coercion and wrongdoing. Some are too embarrassed to share with others how they make a living.
Researching private forums such as “Just Another Lab Rat,” where participants share their experiences while volunteering in medical trials for a profit, can be useful. Explain to those you reach out to that their testimonies have the potential to help protect them and others, by potentially improving the system and thereby potentially improving public health.
Another lesson I learned: In order to dig for useful information and potential breakthroughs, consider partnering with one of the few organizations that seek to protect research subjects. The Citizens for Responsible Care and Research (CIRCARE) is one. If a lawsuit is filed or if a rule is broken, they will know it.
Very little had been published in Spanish on how clinical trials really work before our series “Salud de Alquier” came out. And many Latinos who volunteer in paid studies in the U.S. know little about the trials, the risks involved and their rights as volunteers, before signing informed consents. That is why we consider it essential for reporters to continue to research and to publish stories in Spanish on this topic, which has such an obvious impact on the health of Latino immigrants.