The people who participate in prescription drug trials in countries outside the U.S. often don't get access to the drug once it's approved by the FDA, according to a recent study published in JAMA Network Open.
Drug trials run by American pharmaceutical companies often take place both in the U.S. and other countries. It's cheaper to run trials in lower and low-income countries, and it diversifies the trial population, NPR reported June 11.
But once the FDA approves a drug, trial volunteers outside of the U.S. often lack access to the drug they helped test, the study found. The study was conducted by researchers at Yale School of Medicine in New Haven, Conn.; Stanford University in California; Brigham and Women's Hospital in Boston; and Memorial Sloan Kettering Cancer Center in New York City.
Researchers looked at FDA data to see in which countries 34 drugs had been tested, then checked those countries' regulatory websites to see if the drugs were being marketed there five years after their approval, NPR reported. They looked at drugs made by large drugmakers that were approved in 2012 and 2014, including drugs designed to treat infectious diseases such as HIV and hepatitis C; chronic conditions such as diabetes; and cancers.
Only five drugs had been approved in all the countries where they were tested within five years, and they were less frequently available in poorer countries included in the study, NPR reported.
The FDA-approved drugs were available in nearly half of the high income countries where they were tested, but only 9 percent of upper-middle income countries and 22 percent of lower-middle income countries.
"The people subjecting themselves to experimentation are mostly outside the U.S. The volunteers in other countries don't get back what we get, which is the products when they're actually effective," Peter Bach, MD, a co-author of the study and director of the Center for Health and Policy Outcomes at Memorial Sloan Kettering Cancer Center, told NPR.
Global health advocates have told NPR the study confirms what they've always suspected: People in lower-income countries who participate in drug trials often lack access to the drugs they helped test. But the pharmaceutical industry has disputed the study.
A spokesperson for the Pharmaceutical Research and Manufacturers of America, the industry's biggest lobbying group, told NPR that the study "is based on incomplete and inaccurate data that severely bias the results. In fact, actual sales data show that these products launched in nearly all countries where they were tested, including most countries where the authors claim they have not launched. Furthermore, the study authors did not take into account approval delays that biopharmaceutical companies encounter in many markets around the world based on local regulatory requirements, delaying medicine availability for patients by years."
The researchers said that some delays in approval may be due to slow processes in some countries, but their conclusions remain unchanged, NPR reported.
Manuel Martin, MD, a physician who works with Doctors Without Borders, told NPR the issue of access is particularly prominent with COVID-19 vaccines, which weren't included in the study.
"A lot of testing for some of the vaccines was done in developing countries, which are now at the back of the queue in gaining access," he told NPR. "Patients quite literally put their bodies on the line to test these vaccines, and now these same patients are being told they have to wait, and they can't have access as a priority."
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