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KAI RYSSDAL: It can take years, or longer, for a new drug or medical device to get to market. Even after all the research and development, before the Food and Drug Administration will stamp its seal of approval the drug or device in question has to pass a set of clinical trials.
In theory, those are rigorous and closely controlled tests involving hundreds of people. But a report out today from the Health and Human Services Inspector General says nobody’s keeping an eye on the testers.
Helen Palmer has the story from the Marketplace Health Desk at WGBH.
HELEN PALMER: Nobody from the Inspector General’s Office was available to discuss the report. But one long-time critic of the FDA, Republican Sen. Charles Grassley of Iowa, called the state of human research protection “very bad indeed.”
SEN. CHARLES GRASSLEY: Only about 1 percent of the 350,000 sites where these experiments are going on is ever really viewed.
Grassley says there are only 200 inspectors, and there’s no central registry of research sites. Also, there’s no single agency in charge — the FDA and the Office for Human Research Protection only have partial oversight.
SEN. GRASSLEY: That division, and the low resources to each of them has not been a good mechanism.
Ezekiel Emanuel is a bioethicist at the NIH. He says at the moment, there’s no way to gather all the data from the thousands of trials together.
EZEKIEL EMANUEL: The single best thing we can do to protect clinical research participants is to begin collecting those data, to know what we do that really protects people — and it’s not going to be cheap to do.
There have been widespread calls for a central database of clinical trials. But Emanuel says it must contain the right information to be useful. As things stand, Sen. Grassley says, we protect our animal research guinea pigs better than we do the human kind.
I’m Helen Palmer for Marketplace.
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