Photo illustration by Kate Musselwhite and Heather Fung: Treatment of human 'guinea pigs' hit headlines again after a Wellesley College professor discovered U.S. researchers infected Guatemalans with syphilis in the 1940s. Though clinical trial procedures are different now, as trial conductors are required to get informed consent of participants, experts say human test subjects often don't consider all potential consequences.
This article was originally published in the American Observer. Matthew Boyle also contributed to this report.
A Wellesley College professor unearthed documents showing that in the 1940s, U.S. researchers purposely infected Guatemalans with sexually transmitted diseases — all in the name of science — bringing medical testing on people back into the spotlight.
Professor Susan Reverby, whose discovery prompted anapology from the U.S. Department of State, said the researchers conducted the study to test penicillin, which was developed shortly before the experiment, and the new drug’s effects on the disease. Reverby said she hopes her discovery of what happened in the past will force public health officials to reconsider how new drugs are now tested and approved.
“It’ll be different now, but there are questions out there,” Reverby said of lingering issues. “We have restrictions and protections in place now that are very different. I think the real issue is going to be how we do things in the United States and overseas, and how we protect people is really crucial.”
It would seem that Roberto Abadie, author of the new book, “The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects,” would agree. Even though human subjects today consent to be “guinea pigs,” he said, they are often unaware of the negative consequences of their participation.
Clinical test conductors today are required to get informed consent from human subjects, a huge difference from the Guatemalan trials. But subjects don’t often think about potential side effects or dangerous interactions that might occur due to taking various drugs and going through countless procedures, Abadie said. Nor are they motivated by the desire to contribute to the “greater good” by contributing to medical knowledge, he said.
Abadie said stronger restrictions are needed to safeguard health of participants in clinical trials for new drugs.
“They think of themselves not as doing something altruistic, but as doing a particular kind of work,” Abadie said.
Both Reverby and Abadie agree that drugs have to be tested on humans to see what their ultimate effects are – but they said those doing the testing must do so in an ethical way.
That’s where the ethical practices of pharmaceutical companies come into play.
“Clinical trials are research studies conducted with people who volunteer to take part,” said Ian McConnell, a spokesperson for Merck, a pharmaceutical company, in an e-mail interview. “Each study answers scientific questions and tries to find better ways to prevent, screen for, diagnose or treat a disease. People who take part in clinical trials have an opportunity to contribute to the knowledge of, and progress against a disease such as cancer.”
However, Abadie said that often times, people who participate in clinical trials are motivated by the money they can make. He said human subjects can make up to $20,000 in a year for doing 10 tests, if they plan correctly.
Abadie said that several individuals he spoke to when researching his book were participating in multiple clinical trials – some in upwards of 100 trials — as a way to make money. He said such individuals may put themselves at risk for harmful drug interactions.
He added that often the attitude among participants is: “I don’t think about the risks because I just want the money.”
Abadie said that although the risk posed to individuals participating in clinical drug trials is usually mild and most people do not suffer lasting ill effects, more should be done to track participants at every level of the clinical trial.
He argued for the creation of a centralized registry, which would ensure that those running clinical trials are aware of other drug studies that participants may have been involved in and whether there is any risk of a dangerous drug interaction.
However, Erica Jefferson, who works with the public affairs office at the U.S. Food and Drug Administration, said she thought regulations were adequate. “They’re pretty strong now,” she said.
FDA regulations require that patients be informed about the risks they are undertaking before participating in clinical trials.
“There is a significant list of items that patients are required to be given before they sign the consent [for the trial],” said Cheryl Rosenfeld, who works with CenterWatch, a company that provides clinical trials information for pharmaceutical professionals and patients. She said that federal regulations list a number of these items, such as a description of procedures and potential risks.
Volunteers who are considering whether to participate in a clinical trial must be given plenty of time, without pressure, to make their decision, according to CenterWatch’s website. After volunteers do consent, they are entitled to refuse to participate at any point in the clinical trial for any reason.
A 2007 CenterWatch survey of 620 individuals who volunteered in clinical trials found that 90 percent rated their quality of care as excellent or good. In addition, 91 percent said their experiences were good enough that they would participate again.
However, 21 percent were unsure about the additional risks associated with their clinical trial. More than half of those surveyed participated in a clinical trial in 2007 or 2006, and another third participated in a clinical trial between 2000 and 2005. Of those surveyed, 44 percent said they participated in only one clinical trial and 19 percent reported they participated in two, with another 19 percent participated in five or more.