Undated: Thalidomide in the U.S.

Public awareness about thalidomide increases dramatically, with news reports and congressional hearings about the drug's risks: that expectant mothers taking the sedative might give birth to deformed babies. (Thalidomide sales had already been halted throughout Europe.)

July 15: The Washington Post publishes a front-page story about thalidomide, largely about the efforts of Dr. Frances Oldham Kelsey of the Food and Drug Administration, who worked to prevent her agency from approving the drug for use in the United States. Other news outlets quickly follow up on Morton Mintz's reporting.

* Text of story: @

* "Morton Mintz on the collapse of Congressional oversight" (from www.neimanwatchdog.org): @

* 2012 interview with Mintz: @

July 30: The FDA provides details on thalidomide distribution. From The New York Times: "A total of 1,229 physicians in thirty-nine states and the District of Columbia and one in Canada received test samples of thalidomide, a drug blamed for thousands of birth defects in Europe. ... It has been estimated by Government officials that hundreds or perhaps thousands of Americans were given the drug on an experimental basis. ... A drug concern may make arrangements with doctors for the experimental use of a new drug without Federal approval. The law merely requires that the company keep a record of the shipments and that they be labeled 'caution, new drug limited by Federal law to investigate use.' This was the procedure used by the W.S. Merrell Company of Cincinnati, a reputable drug concern that held exclusive United States rights to distribute thalidomide. The company notified physicians last March to cease giving the drug."

Later estimates indicate that about 2.5 million samples were given out to some 20,000 patients.

August: Dr. Helen Taussig's "The Thalidomide Syndrome" is published in Scientific American. The report provides a history of the drug, discusses its effects on fetuses, and includes Taussig's observations in West Germany, where thalidomide (brand name Contergan) had been much more widely used. She writes: "The one-third who are so deformed that they die may be the luckier ones."

* Profile of Taussig (from National Library of Medicine): @

August 1: President Kennedy opens his press conference with a statement about thalidomide and pending drug legislation. In answer to a follow-up question, Kennedy says, "Every woman in this country, I think, must be aware that it is most important that they check their medicine cabinet, that they do not take this drug, that they turn it in."

* Text: @

* Audio: @

August 7: President Kennedy awards Dr. Kelsey the President's Award for Distinguished Federal Civilian Service.

* Kennedy's remarks (from www.jfklink.com): @

* 1957 executive order creating the award (from archives.gov): @

August 10: Life magazine's cover story carries this headline: "The Full Story of the Drug Thalidomide / The 5,000 Deformed Babies ... The Woman Who Saved Thousands ... The Moral Questions of Abortion and Euthenasia." The article includes the warning box at left and the story of an Arizona woman, Sherri Finkbine, who went to Sweden for an abortion rather than bear the child, which after the operation was found to be severely deformed. (Finkbine had the abortion on August 18).

* Text of Life magazine story: @

In October, Congress would pass, and Kennedy would sign, legislation that strengthened the rules for drug safety and required manufacturers to prove their drugs' effectiveness.

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* "Dark Remedy: The Impact of Thalidomide and Its Revival as a Vital Medicine" (Trent D. Stephens and Rock Brynner, 2001): @

* "Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation" (Philip J. Hilts, 2004): @

* "Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA" (Daniel P. Carpenter, 2010): @

* "Thalidomide Crisis & Drug Regulation" (exhibit at Emory Libraries, Atlanta, Georgia): @

* "Thalidomide and Political Engagement in the United States and West Germany" (from Social History of Medicine, 2002): @

* "Congressman's Report" (from Arizona Rep. Morris K. Udall, August 17, 1962): @

Previous posts about thalidomide:

* William S. Merrell Co. submits drug application (September 8, 1960): @

* Letter in The Lancet raises concerns (December 16, 1961): @

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