转帖医学史集锦——拒绝批准反应停在美国上市的人

清歌一曲月如霜

拒绝批准反应停在美国上市的人

我想起 Frances Kathleen Oldham Kelsey。Kelsey 在1960年加入美国 FDA，她的第一个任务是审查反应停（thalidomide）用于控制早孕反应的申请。当时反应停已在加拿大、日本和很多欧洲国家得到了许可上市，用于控制早孕反应。但 Kelsey 坚持认为反应停的安全数据不够充分，顶住了巨大的压力，坚持拒绝批准反应停在美国上市。

后来的事情大家都知道：反应停在全世界范围内导致了成千上万名新生儿畸形，但美国幸免于难。

因为 Kelsey 医生的巨大贡献，美国总统约翰肯尼迪在1962年向她颁发了 ” President's Award for Distinguished Federal Civilian Service“ ，加拿大温哥华一所中学为了纪念她对社会、尤其是孩子们健康做出的卓越贡献，用她的名字作为校名。

希望中国的药品／食品监督部门将来也出一个 Kelsey 医生这样的英雄。

清歌一曲月如霜

Frances Oldham Kelsey
Frances Kathleen Oldham Kelsey, Ph.D., M.D., (born 24 July 1914) is a pharmacologist, most famous as the reviewer for the U.S. Food and Drug Administration (FDA) who refused to authorize thalidomide for market because she had concerns about the drug's safety. Her concerns proved to be justified when it was proven that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening the FDA's oversight of pharmaceuticals.

Contents [hide]
1 Birth and education
2 Early career and marriage
3 Work at the FDA and thalidomide
4 Legacy and awards
5 See also
6 Footnotes
7 References
8 Further reading


[edit] Birth and education
Born Frances Kathleen Oldham in Cobble Hill on Vancouver Island, British Columbia,[1] Kelsey graduated from high school at age 15,[2] and enrolled at McGill University to study pharmacology. At McGill she received both a B.Sc.(1934) and a M.Sc.(1935) in pharmacology,[1] and "on [a] professor's urging, wrote to EMK Geiling, M.D., a noted researcher [who] was starting up a new pharmacology department at the University of Chicago," asking for a position doing graduate work.[2] 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. During her second year, Geiling was retained by the FDA to research unusual deaths related to Elixir Sulfanilamide, a sulfonamide medicine. Kelsey assisted on this research project, which showed that the 107 deaths were caused by the use of diethylene glycol as a solvent. The next year, the United States Congress passed the Federal Food, Drug, and Cosmetic Act of 1938.[2] That same year Kelsey successfully completed her studies and received a Ph.D. in pharmacology at the University of Chicago in 1938.[2] Kelsey's work for Geiling is credited with her interest in teratogens — that is, drugs that cause congenital malformations.[4]

[edit] Early career and marriage
Upon completing her Ph.D., Kelsey joined the University of Chicago faculty. In 1942, like many other pharmacologists, Kelsey was looking for a synthetic cure for malaria. As a result of these studies, Kelsey learned that some drugs are able to pass through the placental barrier.[5] While there she also met fellow faculty member Dr. Fremont Ellis Kelsey, whom she married in 1943.[2]

While on the faculty at the University of Chicago, Kelsey received an M.D.[2] She supplemented her teaching with work as an editorial associate for the American Medical Association Journal for two years. Kelsey left the University of Chicago in 1954, decided to take a position teaching pharmacology at the University of South Dakota, and moved with her husband and two daughters to Vermillion, South Dakota, where she taught until 1957.[1]

[edit] Work at the FDA and thalidomide

1962: Frances Kathleen Oldham Kelsey receiving the President's Award for Distinguished Federal Civilian Service from President John F. KennedyIn 1960, Kelsey was hired by the FDA in Washington, DC. At that time, she "was one of only seven full-time and four young part-time physicians reviewing drugs"[2] for the FDA. One of her first assignments at the FDA, was to review application by Richardson Merrell for the drug thalidomide (under the tradename Kevadon) as a tranquiliser and painkiller with specific indications to prescribe the drug to pregnant women for morning sickness. Even though it had already been approved in Canada and over 20 European and African countries,[6] she withheld approval for the drug, and requested further studies.[1] Despite pressure from thalidomide's manufacturer, Kelsey persisted in requesting additional information to explain an English study that documented a nervous system side effect.[2]

Kelsey's insistence that the drug should be fully tested prior to approval was dramatically vindicated when the births of deformed infants in Europe were linked to thalidomide ingestion by their mothers during pregnancy.[7] Researchers discovered that the thalidomide crossed the placental barrier and caused serious birth defects in infants.[5] She was hailed on the front page of The Washington Post as a heroine[8] for averting a similar tragedy in the US.[9] Morton Mintz, author of The Washington Post article, said "[Kelsey] prevented ... the birth of hundreds or indeed thousands of armless and legless children."[8] The public outcry was swift and drug testing reforms were passed unanimously by Congress a few months later.[7] The drug testing reforms required "stricter limits on the testing and distribution of new drugs"[5] to avoid similar problems. The amendments also, for the first time, recognized that "effectiveness [should be] required to be established prior to marketing."[7]

As a result of her blocking American approval of thalidomide, Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by President John F. Kennedy,[10] becoming the second woman to receive that award.[11]

After receiving the award, Kelsey continued her work at the FDA. There she played a key role in shaping and enforcing the 1962 Amendments.[9] She also became responsible for directing the surveillance of drug testing at the FDA.[1] Kelsey finally retired from the FDA in 2005, at age 90, after 45 years of service.[6]

[edit] Legacy and awards

Dr. Kelsey (age 87) at the FDA Reception commemorating her induction into the National Women's Hall of FameIn 2005, the FDA honored Kelsey by naming one of their annual awards after her. In announcing the awards, Center Director Steven K. Galson, M.D., MPH, said “I am very pleased to have established the Dr. Frances O. Kelsey Drug Safety Excellence Award and to recognize the first recipients for their outstanding accomplishments in this important aspect of drug regulation.”[12]

1962 • President's Award for Distinguished Federal Civilian Service[6]
1963 • Gold Key Award from University of Chicago, Medical and Biological Sciences Alumni Association[13]
2000 • Inducted into the National Women's Hall of Fame[11]
2001 • Named a Virtual Mentor for the American Medical Association[14]
2006 • Foremother Award from the NRC for Women & Families [15]
The Frances Kelsey Secondary School in Mill Bay, British Columbia is named in her honour.[16]

Asteroid (6020) Kelsey is named in her honour.[17]

清歌一曲月如霜

拒绝批准反应停在美国上市的人

nunqing

嗯 非常敬佩这位民族英雄

syhorchid

反应停,医药史上的悲剧一幕

lunmulunmu

杂呀                       

yuansoul

这个人还在是么？

清歌一曲月如霜

弗朗西丝奥尔德姆凯尔西
弗朗西丝凯瑟琳·奥尔德姆凯尔西博士，医学博士（1914年7月24日出生）的药理，作为审稿人，美国食品和药物管理局（FDA）拒绝授权沙利度胺市场最有名的，因为她有担忧药物的安全性。事实证明她的担忧是有道理的，当它被证明，沙利度胺造成严重的出生缺陷。通过加强FDA的药品监督的法律相交Kelsey的职业生涯。

目录[隐藏]
1出生和教育
2早期事业和婚姻
3工作在FDA和沙利度胺
4遗产和奖项
5参见
6脚注
7参考
8进一步阅读


[编辑]出生和教育
不列颠哥伦比亚省温哥华岛，弗朗西丝·凯瑟琳·奥尔德姆Cobble Hill中出生的，[1]凯尔西在15岁高中毕业，[2]和就读于麦吉尔大学学习药理学。她在麦吉尔大学获得理学士（1934年）和硕士（1935年）在药理学，[1]和“在[a]教授的催促下，写信给EMK Geiling，医学博士，著名研究员[谁]在芝加哥大学开始了一个新的药理学部门“，要求做毕业作品的位置。[2] Geiling假设弗朗西斯是一个男人，但弗朗西斯接受的位置，而不是先澄清她的性别，[3]，并开始工作1936年Geiling。在她的第二个年头，Geiling由FDA保留相关药剂磺胺，磺胺药研究异常死亡。凯尔西协助这一研究项目，这表明使用二甘醇作为溶剂，造成107人死亡。明年，美国国会通过了“联邦食品，药品和化妆品法案”1938年[2]。同年凯尔西成功地完成了她的学业，并获得了博士学位于1938年在芝加哥大学的药理学。[2] Kelsey的工作Geiling归功于她的兴趣在致畸 - 也就是说，导致先天性畸形的药物。[4]

[编辑]早期的事业和婚姻
在完成她的博士学位，凯尔西加入大学芝加哥教员。 1942年，像许多其他的药理学家，凯尔西一直在寻找一种人工合成的治愈疟疾。由于这些研究的结果，凯尔西了解到，有些药物是能够通过胎盘屏障。[5]虽然她也遇到了同系教员博士弗里蒙特埃利斯凯尔西，她在1943年结婚的人。[2]

虽然在芝加哥大学的教师，凯尔西收到MD [2]她补充，她的教学工作两年的美国医学协会杂志“的社论联营公司。凯尔在1954年离开芝加哥大学，决定采取的立场在南达科他州大学的药理学教学，感动了她的丈夫和两个女儿朱红，南达科他州，在那里她任教，直到1957年。[1]

[编辑]工作在美国FDA和沙利度胺

1962年：弗朗西斯凯瑟琳的奥尔德姆凯尔西接收总统约翰·F·KennedyIn 1960总统奖杰出联邦民用服务，凯尔西被聘为由FDA在华盛顿特区。当时，她“是一个只有7个全职及兼职四个年轻人医师审查药品”[2]的FDA。她的第一个任务在FDA，审查申请，由理查德森梅里尔特定适应症开药给孕妇孕吐作为镇静剂和止痛药的药物沙利度胺（根据商标Kevadon）。尽管它已经被批准在加拿大和超过20个欧洲和非洲国家中，[6]她隐瞒批准的药物，并要求进一步研究。[1]尽管沙利度胺的制造商的压力，凯尔西坚持要求额外的信息来解释的英语学习，记录了神经系统的副作用。[2]

Kelsey的坚持，药物应该被完全测试之前批准了显着平反时，出生畸形婴儿在欧洲被链接到沙利度胺摄取由他们的母亲在怀孕期间。[7]研究发现，沙利度胺越过胎盘屏障，并造成了严重的出生在婴儿的缺陷。[5]她被人们誉为“华盛顿邮报”的头版上担任​​女主角[8]在美国，为避免类似的悲剧。[9]莫顿明茨，“华盛顿邮报”的文章中，作者说：“凯尔防止数百或什至数千无臂和腿的儿童的诞生。“[8]舆论哗然，迅速和药物测试的改革一致通过由美国国会在几个月以后。[7]的药物测试的改革需要”更严格地限制新药的测试及分销“[5]，以避免类似的问题。修订亦首次承认，“有效性[应]之前建立的营销”。[7]

由于因她阻止美国批准沙利度胺，，凯尔西被授予总统奖杰出联邦民用服务由总统约翰·F·肯尼迪，[10]成为获得该奖项的第二个女人。[11]

接受颁奖后，凯尔西继续她的工作在美国FDA。在那里，她在塑造和执行1962年修订起到了关键作用[9]。她也成为在FDA负责指挥监控的药物测试[1]。凯尔终于在2005年从美国FDA退休，在90岁后，45服务年期。[6]

[编辑]遗产和奖项

凯尔西博士（87岁）在FDA招待会，纪念她感应到了2005年，美国FDA历史悠久的凯尔西FameIn全国妇联大厅后，她命名的年度奖项之一。在宣布奖项时，中心主任史蒂芬光Galson，MD，MPH说：“我很高兴建立的弗朗西丝博士O.凯尔西药品安全优秀奖，并在这个重要的方面认识到他们的杰出成就的首批受惠者药品监管。“[12]

1962年总统奖杰出联邦民用服务[6]
1963•来自芝加哥大学医学和生物科学学院校友会金钥匙奖[13]
2000•全国妇女名人堂入主[11]
2001•美国医学协会命名虚拟导师[14]
2006鼻祖奖NRC妇女及家庭[15]
弗朗西丝·凯尔西在Mill Bay，不列颠哥伦比亚省中学被命名为她的荣誉。[16]

在她的荣誉被命名小行星（6020）凯尔西[17]