Question

In the 50s-60s a medication to treat "morning sickness" was approved and given to pregnant women during the first trimester of pregnancy since was considered as safe after all the research and clinical trials the pharmaceutical company provided for its approval. Some of the women who took the medication, delivered a baby with a malformation called phocomelia, characterized by absence of the proximal portion of a limb or limbs(most commonly in the arms), you could look at it "the thalidomide babies". Based on the first 10 chapters what do you think went wrong, or do you think that the pharmaceutical company hided/ modified the results of the trials?

Answer 1

Answer :- In the 50s-60s a medication to treat morning sickness was approved and given to pregnant women during the first trimester of pregnancy based on makers safety claims . They advertised their products as completely safe for everyone , including mother and child called as thalidomide. Dr W M Bride alleviate it morning sickness and started to recommending this off-label use of the drug to his pregnant patients. In 1961 McBride began to associate this so called harmless compound with severe birth defects in the babies he delivered . The drug interfered with the babies normal development, causing many of them to be born with phocomelia, resulting in shortened, absent , or flipper limbs. A German newspaper soon reported the druge adverse reaction , by March 1962 the drug was banned in most countries . In July 1962 , president J F Kennedy and the American press began praising their heroine, FDA inspector Frances Kelsey, who prevented the drugs approval with in thevU.S despite pressure from pharmaceutical company and FDA supervisors.

It was Kelsey who felt the application for thalidomide contained incomplete an insufficient data on its safety and effectiveness. Even if data where available , however, they may not have been entirely reliable at the time , clinical trials did not require FDA approval, nor were they subject to oversight.

Thus the tragedy that engulfed thalidomide and Kelsey's wise negation approve the drug helped motivated the Kefauver Harris Drug Amendment Act in 1962 to tightened restrictions surrousurrousurveillance and approval process for drugs to be sold.

Thus it clearly shows pharmaceutical company hides the data in collaboration with the professionals , that help them to approve this drug with out measuring it's negative impact to the health of pregnant women and fetus.