Health

Institute who grew up in Kashmir

It can be genuinely thrilling when a new drug is approved for use in the U.S. It may be a big step forward in treating folks with, say, HIV or diabetes or breast cancer.

But sometimes the very people who took part in the trials to determine if the drug is effective and safe may not be able to benefit.

That’s the conclusion of a new study published in JAMA Open Network.

The study looked at drug trials necessary to gain approval from the U.S. Food and Drug Administration. The trials take place in the United States but in other countries as well — sometimes in countries classified as lower- and lower-middle income. It’s cheaper to run trials there. And the potential test subjects can add to the diversity of the overall test population.

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The study authors wanted to see if this international group of volunteers get access to the drug once it’s approved.

They looked at FDA approvals of novel drugs made by large companies in the years 2012 and 2014, including drugs for infectious diseases such as HIV and hepatitis C, chronic conditions including diabetes, and cancers such as breast cancer and colorectal cancer.Article continues after sponsor message

Five years after FDA approvals of 2012 and 2014, they checked to see the status of the 34 drugs. Only five of them had been approved in all the countries where they were tested. And the drugs were less frequently available in the poorer countries included in the study.

“The people subjecting themselves to experimentation are mostly outside the U.S.,” says Peter Bach, a co-author of the study and director of the Center for Health and Policy Outcomes at Memorial Sloan Kettering Cancer Center. “The volunteers in other countries don’t get back what we get, which is the products when they’re actually effective.”

Pharmaceutical companies vigorously dispute the study. But global health advocates say it confirms what they’d always suspected. “These findings didn’t really come as a surprise,” says Junaid Nabi, a New Voices fellow at the Aspen Institute who grew up in Kashmir. Nabi, a physician who writes about global health and bioethics, says many practitioners on the ground in low resource countries have had their suspicions about equity and access to drugs. “I think what this study has done is provide the numbers and some evidence to what a lot of global health thinkers as well as practitioners on the ground intuitively understood,” he says.

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