| Getting a drug approved by the FDA is a long and expensive slog. Much of the nitty-gritty work is done by independent research centers that recruit volunteers, dispense the drugs (or placebos), and then carefully monitor patients for outcomes and side effects. These research centers are heavily monitored by their private partners and by the FDA itself. But what would happen if one of them was run by a person who didn't care at all about the scientific process? Someone who would brazenly cheat, cut corners, and then take millions in fees? That question is at the center of a riveting Backchannel article by longtime contributing editor Brendan I. Koerner, who tells the story of an independent research center run by Sami Anwar, a con man of breathtaking shamelessness. If Anwar's center didn't have enough blood samples, they'd draw the blood of center employees and claim it came from volunteers. If employees complained, Anwar would bully and harass them. The tires of one employee's car were slashed. Another received bizarre phone threats suggesting she was being surveilled. To be sure, Anwar's fraudulent research center was an outlier in a larger system that is rigorous and reliable. But the story also illustrates how "the clinical-trials industry, like so many of our most vital institutions, operates on the assumption that even the most grievous errors are made in good faith." Sometimes, as Koerner's piece reveals, the only way to stop bad faith is with good people. Mark Robinson | Features Editor, WIRED |
0 Comments:
Post a Comment