The NY Times runs this article which is related to my last post about pharmaceutical research and the "lemon-like" market in which pharmaceuticals trade. It is also related to an earlier post in which I described how elixir of sulfinilamide helped lead to tougher FDA rules.
Dr. Frances Kelsey played an important role in the latter episode and in the thalidomide episode that left many European children with serious birth defects (but not US children thanks to Dr. Kelsey).
Here's an excerpt:
She arrived at the F.D.A. in 1960 as part of a new cadre of scientists who had begun insisting that drugs show clear evidence of effectiveness as a condition for approval, even though Congress had yet to grant the agency explicit authority to enforce that. Drugs could be sold 60 days after their makers filed information with the agency as long as it did not object; companies routinely sent new remedies to doctors and asked them to try the medicine in patients. Such testing was uncontrolled and entirely anecdotal.
Dr. Kelsey demanded better tests for thalidomide. She also distrusted Merrell, a company that had a history of confrontations with the F.D.A. She soon discovered that Kevadon had been linked in Europe with reports of nerve damage — reports the company had failed to provide her.
“I had the feeling throughout the day,” she wrote after a meeting with company executives, “that they were at no time being wholly frank with me and that this attitude has obtained in all our conferences, etc., regarding this drug.”
Company officials complained about Dr. Kelsey to her superiors, who supported her. When evidence became irrefutable that Kevadon caused horrendous birth defects, the company quietly withdrew its application.
Merrell executives had been insisting that “I was depriving people of this thing,” she said in the recent interview. “And then when it happened, I was so relieved to get them off my back. Amazing.”
Please read the entire article and meditate as I often do on how often large and largely unfettered private interests pose a much greater threat to people than a government that is charged with regulating those interests.
Hat tip to Ecrive.