Talk:Frances Oldham Kelsey

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)

The paragraph under Birth and Education refers to her twice as Oldham, and twice as Kelsey, all before her marriage to Dr. Fremont Ellis Kelsey. I'm not sure of the correct style for using a woman's maiden and married names in a biographical article like this (or I would correct it myself), but I'm certain that consistency in choosing one name or the other should be followed. --J5cochran (talk) 06:17, 19 May 2015 (UTC) I added the bit about prenatal fluoride as an example of how the 1962 law can cut both ways. Ray

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)

Research

Additional Info

Dr Kelsey was born July 24 1914 not June 24 1914 please allow me to make the correction and stop reverting to the incorrect birthdate. MrAndreae (talk) 02:06, 3 December 2008 (UTC)

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 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. (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. {{cite book}}: Unknown parameter |coauthors= ignored (|author= suggested) (help)

Kelsey's delay reasons

• "Q: "What is peripheral neuritis?"". Frequently Asked Questions. Thalidomide Victims Association of Canada. Retrieved 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 2006-08-14.{{cite web}}: CS1 maint: numeric names: authors list (link) "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!"

Unused References

• Eaton, Mark (May 2001), "Letters to the Editor: Praise for Dr. Kelsey", FDA Consumer, 35 (May–June 2001) {{citation}}: |access-date= requires |url= (help).
• Kupec, Ivy Fleischer (July 16, 1998), "FDA Approves Thalidomide for Hansen's Disease Side Effect, Imposes Unprecedented Restrictions on Distribution", FDA Talk Paper, Food and Drug Administration, retrieved August 14, 2006.
• Perri III, Anthony J, "A review of thalidomide's history and current dermatological applications", Dermatology Online Journal, 9 (3): 5, retrieved August 14, 2006 {{citation}}: Unknown parameter |coauthor= ignored (|author= suggested) (help).
• Seidman, Lisa A. (September 2002), "Frances Kelsey & Thalidomide in the US: A Case Study Relating to Pharmaceutical Regulations", The American Biology Teacher, 64 (7): 495–500, doi:10.1662/0002-7685(2002)064[0495:FKTITU]2.0.CO;2 {{citation}}: Unknown parameter |coauthor= ignored (|author= suggested) (help)
• CLASSROOM ACTIVITY: Frances Kelsey and Thalidomide in the United States, retrieved August 14, 2006

Critical of Kelsey's efforts

• Harris, Steven B (1992), The Right Lesson to Learn from Thalidomide.
• A History of Nonprescription Product Regulation (PDF), 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.

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

Good Article status review

Frances Oldham Kelsey GA Reassessment

This discussion is transcluded from Talk:Frances Oldham Kelsey/GA1. The edit link for this section can be used to add comments to the reassessment.

This article has undergone a reassessment as part of the GA sweeps performed by the Good Article Project Quality taskforce in order to ensure that it still meets the requirements for Good Article status.

The article is well-written and easy to follow. My concerns are:

1. "Despite Geiling assuming that Frances was a man,[3] she accepted the position and began working for Geiling." - This is confusing. Was Frances less likely to accept the position because of the confusion?
2. In the "Work at the FDA and thalidomide" section, it would be nice if a brief explanation of what thalidomide was used for could be included, as much of the article revolves around the drug.
3. Likewise, what is the "Kefauver Harris Amendment of 1962"? Is it just the "drug testing reforms"? If so, the following sentence would read better as "These drug testing reforms..."
4. Section formatting. I think the "Continued work at the FDA" heading should be removed altogether. The first paragraph works better as part of the previous section. The second paragraph would work better in the "Legacy" section.
5. A reference for the school being named after her is needed.
6. The first two items in the "See also" section are already in the prose and should be removed from the "See also" list.
7. The biggest problem with this article is its verifiability. Page numbers are needed for the print sources. Without page numbers, the references are not much use for someone wanting to verify the facts or use this article as a guideline for further research.
8. Reference 15 is a bare url and needs more information (title, publisher, and access date; author's name and publication date if available)
9. Could a "Further reading" section be added with some relevant books or reliable websites that aren't already used in the article? This isn't necessary for GA status, but it would be helpful to readers.

I will place this reassessment on hold for seven days to allow for improvements to be made. If these concerns can be addressed within this timeframe, the article will remain listed as a Good Article. Thanks, GaryColemanFan (talk) 07:10, 15 August 2009 (UTC)

I'll be happy to address the items above in the article; however, even if none of them were addressed I don't think that the article would fail the GA criteria. --Trödel 16:41, 15 August 2009 (UTC)

I apparently wasn't fully awake when I was doing the review. The sources I mentioned above are all online, so there is no need for page numbers. There are a few dead links (see [1]). I'll see what I can do about updating them with archived versions. GaryColemanFan (talk) 20:11, 15 August 2009 (UTC)

Well, updating the links was easier than I thought it would be. I also added the missing citation and the information for another citation. It's just a little bit of copyediting left now. GaryColemanFan (talk) 20:28, 15 August 2009 (UTC)

Thanks for updating the links - I'll address the remainder of the items later tonight - there are some additional things I'd like to include in the article and I'm thinking I should try to include those as well when making the changes you suggest. --Trödel 10:40, 16 August 2009 (UTC)

I reworded the sentence on the gender confusion. The note clarifies the differences. I also addressed the other issues listed above. I included a Further reading section with references that were on the talk page. Let me know if additional changes are suggested --Trödel 09:57, 20 August 2009 (UTC)

You should check out Protecting America's Health by Philip J. Hilts. He has a good descripton of the incident at FDA. You can read some online through google books here - [2]. I would recommend trying to incorporate this information into the article. Remember (talk) 17:41, 20 August 2009 (UTC)

I feel that the article now meets the Good Article standards, so I a closing this reassessment as keep. My suggestions for future improvements would be: (1) a longer lead section that summarizes the full article, and (2) perhaps reorganizing the "Legacy and awards" section so that the bullet list comes after the section's prose rather than in the middle of it. These shouldn't prevent it from GA status, though. Great job on the article. GaryColemanFan (talk) 18:39, 20 August 2009 (UTC)

Thank you! I will look at Hilts article. I have wanted to expand this article some with criticisms of Kelsey but have never got around to it. --Trödel 01:59, 21 August 2009 (UTC)

Another source

Google Book Search has a whole copy of an old Life Magazine coverstory on the Thalidamide tragedy and Dr. Kelsey. You can find the article here [3]. It looks like it might have a lot of good information to incorporate into the article. Remember (talk) 21:23, 1 October 2009 (UTC)

Incorrect word

Under the section "Birth and Education", a sentence reads as follows: "Geiling assumed that Frances was a man, but Frances accepted the position rather than clarifying her gender first,[3] and began working for Geiling in 1936." The word "gender" should be changed to "sex". Sex refers to the biological form of a female/woman, whereas gender refers to the characteristics of femininity or masculinity. I corrected this sentence this morning, but it was changed back. The footnote supports this when it states, "Kelsey asked her professor at McGill if she should wire back and explain that Frances with an 'e' is female...Bren (2006)." Kelsey didn't clarify that she was a female (sex), not feminine (gender). Clarifying her sex would entail saying, "I'm a female/woman". Clarifying her gender would entail saying, "I'm feminine". Gender is simply not the correct word to use. Please accept this correction. Someone stated, "sex reads too awkward...". It doesn't matter how you "think" it reads, gender is simply not the correct word. Get your mind out of the gutter and stick with the correct facts, please. Thank you. (69.140.54.3 (talk) 01:02, 13 October 2012 (UTC))

Sex or gender is equally correct - her biology wasn't really in question, it was any sort of femininity. She's a cisgender individual, so stating that her "gender" is female rather than male isn't really all that different from saying her "sex" is female (both are accurate). Is there any evidence that Dr. Kelsey identified as anything but female? She identified as "Dr." not "Ms." to be sure, but that's not the question at hand. Whether she dodged sexism by confusion over her sex or her gender is kind of a moot point, so the article is free to use the equally accurate term that's less likely to be misunderstood. 73.19.23.200 (talk) 16:22, 8 August 2015 (UTC)