On Ordinary Heroes and American Democracy by Gerald M. Pomper

Author:Gerald M. Pomper [Pomper, Gerald M.]
Language: eng
Format: epub
Tags: Biography & Autobiography, Political, History, United States, General
ISBN: 9781594513916
Google: 4IJ8PwAACAAJ
Goodreads: 311684
Publisher: Routledge
Published: 2004-04-10T00:00:00+00:00

Thalidomide v. Kelsey

In September 1960, one month after joining the FDA, Kelsey was assigned her first drug review, of thalidomide, heading the usual three-person team of a physician, chemist, and pharmacologist. The job appeared to be a routine review, an easy way to introduce her to her new duties. In the context of her job, Kelsey is best seen as a scientist, working for a bureaucracy, and trying to further the purposes of that bureaucracy—safe drugs. For the FDA, the review of thalidomide was but an example, ultimately exceptional in its consequences, of standard practices. Illustrating these bureaucratic routines, Kelsey and her associates first delayed approval of thalidomide for purely technical reasons, as demonstrated in this matter-of-fact list of detailed objections drawn from “Denial of Approval for Thalidomide in the U.S.”: “the animal data were not reported in full detail”; “the chronic toxicity data were incomplete”; there were “deficiencies relating to details of the manufacturing process”; “the asymmetrical carbon atom in the molecule [an indicator of possible problems] was noted”; “insufficient cases had been studied”; “the claims of safety were not adequately supported.”

After these technical issues were raised, the drug company submitted a new application, only to meet with new objections. A bureaucratic pattern developed. Limited to sixty days for its review, the FDA team would reject Merrell’s application, thereby beginning a new cycle. Merrell would submit new data, the reviewers would raise new objections, and the clock would start again. In the meanwhile, Kelsey had also begun to worry about the possible connection between thalidomide and peripheral neuritis. Her doubts were based on a research note in a British scientific journal that she had found almost by accident as she was checking references on another drug. The manufacturer, Merrell, still wanted to go ahead with Kevadon, merely adding a warning label to the medication. “Dr. Kelsey shook her head. She pointed out that they were only talking about a sleeping pill. It was not a cure for some hitherto incurable disease from which people were dying daily. As she saw it, giving Merrell a license to make people sick would be inexcusable.”21

The FDA team’s repeated objections brought complaints from the manufacturer, Kelsey remembered, that she was “dragging [her] feet … nit-picking and asking for unnecessary stuff. There were some raised eyebrows.” Merrell appealed to Kelsey’s superior, then went up the bureaucratic ladder to plead with the head of the agency’s medical division, and finally went to the top, visiting the head of the FDA. As Kelsey puts it, rather mildly: “I guess they were a little aggressive on it. You sort of expect that, they were anxious to get it on the market.” Writing about Women of Courage, Margaret Truman is more forceful: “It was a subtle way of applying pressure by letting Dr. Kelsey know that Merrell had access to much more important people in the FDA.”22 In the circumstances, the politically prudent action would have been to accept the manufacturer’s assurances and its promises of careful marketing.23

Kelsey remained obdurate.

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