Talk:Frances Oldham Kelsey

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[edit] Rewrite

I rewrote this article after looking up information on thalimide. It is pretty choppy - needs a more consistent style and smoother transitions. Should have enough references for a living person now. Trödel 07:02, 1 May 2006 (UTC)

I'm happy with it now - removing the copyedit notice Trödel 02:10, 3 May 2006 (UTC)

[edit] Good Article Nomination

I nominated this article as a "Good Article" - please comment on any objections or suggestions here. Trödel 02:14, 3 May 2006 (UTC)

promoted well done to all editors Gnangarra 13:56, 19 May 2006 (UTC)

[edit] Research

[edit] Additional Info

I have found some evidence of additional awards in 1962 from women's organizations - making a note of it here since I am on a self imposed wikipedia slowdown for a few days to a week Trödel 02:19, 7 May 2006 (UTC)

Thalidomide. March of Dimes Birth Defects Foundation. Retrieved on 2006-08-14. "The worldwide thalidomide tragedy changed the way drugs are developed, tested and regulated in the United States, significantly broadening FDA authority (3). Dr. Kelsey often is credited with sealing the FDA’s reputation as the world’s premier authority on food and drug safety."

Stephens, Trent D., Brynner, Rock (2001). Dark remedy : the impact of thalidomide and its revival as a vital medicine. Cambridge, Mass: Parseus Publishing. ISBN 0738204048, Dewey Call No.: 616.043 Ste.

[edit] Kelsey's delay reasons

  • Q: "What is peripheral neuritis?". Frequently Asked Questions. Thalidomide Victims Association of Canada. Retrieved on 2006-08-14. "... Peripheral neuritis is a form of nerve damage. Patients using Thalidomide are advised to immediately stop taking Thalidomide and contact their doctor if they experience the first symptoms associated with nerve damage which include burning, numbness, or tingling of the arms, hands, legs, or feet. ... It was concern over reports of this side effect that led to Dr. Kelsey’s delay of the original Thalidomide application for licensing in the United States."
  • skeptic06. Big Pharma lobbying at its 'best'. mydd.com (My Direct Democracy). Retrieved on 2006-08-14. "The FDA official given charge of the case was one Dr Frances Oldham Kelsey, who was so officiously nitpicking as to query, for example, the fact that the drug when given to animals had failed to make them sleepy!"

[edit] Unused References

Critical of Kelsey's efforts

  • Harris, Steven B. 1992. The Right Lesson to Learn from Thalidomide.
  • A History of Nonprescription Product Regulation "Frances Kelsey resisted undue pressure to approve thalidomide, being labeled as an obstructionist federal bureaucrat. However, her forthright refusal to bow to industry pressure saved the lives of an untold number of babies."
  • Kefauver-Harris Amendments of 1962 fdareview.org The Independent Institute. "The role of thalidomide in the passage of the 1962 Amendments is riddled with unfortunate ironies. First, the episode aroused great public empathy for human suffering, but no thought was given to the suffering that was bound to result from the ever more confining grip on drug development, availability, and information. Second, people cited thalidomide in claiming that drug approval delay is a blessing, but the pre-1962 FDA had proven to be sufficiently slow to avoid thalidomide harm in the United States. Third, the old law of 1938 already required premarket approval for safety. Nothing about thalidomide even superficially recommended premarket approval for efficacy."
  • The Thalidomide Incident Food and Drug Legislation - The Story Behind the Law. Lists reasons why Kelsey refused to approve.

[edit] Collateral References

May have info on Kelsey

  • Mintz, Morton (1965) The therapeutic nightmare; a report on the roles of the United States Food and Drug Administration, the American Medical Association, pharmaceutical manufacturers, and others in connection with the irrational and massive use of prescription drugs that may be worthless, injurious, or even lethal. Boston, Houghton Mifflin. LOC HD9666.6 .M55, Dewey 338.4761519.Library of Congress catalog entry
  • McFadyen, R.E. (1976). Thalidomide in America: A Brush With Tragedy. Clio Medica, 11, (2), 79-93.
  • Mulliken, J. (August 10, 1962). A Woman Doctor Who Would Not be Hurried. Life Magazine, 53, 28-9. Call# AP2 .L547
  • Young, J.H. (1983). Sulfanilamide and Diethylene Glycol. In J. Parascandola and J.C. Whorton (Eds.), Chemistry and Modern Society: Historical Essays in Honor of Aaron J. Ihde (pp. 105 -125). Washington D.C.: American Chemical Society.
  • Google Scholar on Kelsey
  • Arthur Daemmrich, Georg Krücken. RISK VERSUS RISK: Decision-making Dilemmas of Drug Regulation in the United States and Germany abstract
  • A Brief History of the Center for Drug Evaluation and Research fda.gov
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