Posted by & filed under Child Development, Disorders of Childhood, Disorders of Childhood, Physical Development: Birth, Motor Skills, and Growth, Physiology, Prenatal Development, Uncategorized.

Source: The Globe and Mail

Date: November 24, 2014

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Links: Video: http://bcove.me/q1bb3zon

Article: http://www.theglobeandmail.com/news/national/canadian-doctor-averted-disaster-by-keeping-thalidomide-out-of-the-us/article21721337/

The drug Thalidomide, which was found to be a powerful teratogen, was approved for use in Canada in the 1960’s largely on the strength of it already having been approved for use in the UK, other commonwealth countries and Germany. It was never approved for use in the United States because a Canadian, Francis Kelsey, only one month on the job in Washington, was concerned that there was not enough data on the drug’s effects provided by the drug company wanting to market it in the United States. Her concerns were validated in tragic ways by the extent of the effects of the drug seen in infants born in Canada and elsewhere. Kelsey’s training and career and accomplishments (including an award from President Kennedy for her stand on Thalidomide) make her a pioneer of women in science.

Questions for Discussion:

  1. What role did Francis Kelsey play in the review of Thalidomide in the United States? What standards and expectations should regulators hold drug companies to in moving drugs towards human use? How have these changed historically?
  2. Should we be more or less concerned about the potential effects of drugs in prenatal development today as compared to the 1960’s when Francis Kelsey was working?

 

Posted by & filed under Child Development, Disorders of Childhood, Legal Ethical Issues, Physical Development: Birth, Motor Skills, and Growth, Prenatal Development, Uncategorized.

Description: Read the article describing the long term developmental effects on Canadians whose Mothers were given the drug Thalidomide to treat insomnia and nausea early in their pregnancies (in the 1960’s).

Source: The Globe and Mail

Date: November 21, 2014

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Link: http://www.theglobeandmail.com/news/national/the-aftermath-of-thalidomide/article21689771/

Thalidomide is a textbook teratogen. Prescribed as a sleeping pill or an anti-nausea treatment it was given to many people but also to pregnant women in the early 1960’s when there was less caution about the potential side-effects about any drug on pregnant women and their prenatally developing fetuses in an time when “better living through chemistry” (a version of a slogan used at the time by DuPont) was a common belief. If the drug was taken within a fairly tight sensitive period of prenatal development it effected the growth buds that were to produce the long bones of the arms and/or legs (among other systems) and causing a condition called Phocomelia (flipper limbed) which, prior to Thalidomide as VERY rare. The article describes the short and long term effects produced by Thalidomide 95 Canadians as well as the meagre settlements and supports they have received compared to those provided to “Thalidomide Babies” in other countries.

Questions for Discussion:

  1. What were Thalidomide’s teratogenic effects, when did they occur in prenatal development, and why might these timing or sensitive period developmental issues made it difficult to connect Thalidomide to its effects?
  2. What sort of regulatory processes and related responsibilities are suggested by the experiences of Canada’s Thalidomide Babies?