Oh Man, Avandia - Pharmaceutical Executive


Oh Man, Avandia
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Pharmaceutical Executive

6. In February 2006, an FDA safety officer recommended that the large number of swelling problems caused by Avandia and Actos be consolidated into a single prominent black-box warning. The agency responded by:

A. Ignoring her because she was known as "Black- Box Johann-Liang"

B. Rejecting her recommendation but placating her with an "employee of the month" citation

C. Rebuking her and removing her from the Avandia review

D. Accepting her recommendation and filing it away

7. Which of the following did not take place during the Avandia dustup:

A. Andrew von Eschenbach told Congress that FDA had decided in March to put a black-box warning on Avandia

B. On ABC's Nightline, Glaxo's J.P. Garnier said, "We welcome Dr. Nissen's analysis because patients benefit from a robust debate about drug safety."

C. An FDA PR consultant sent reporters an e-mail accusing Dr. Nissen of a vendetta against drug companies that refuse to hire his clinic to do drug trials.

D. Dr. Steven Nissen acknowledged having been in touch with certain congressmen prior to the release of the New England Journal of Medicine report.

Answers: 1 (B); 2 (C); 3 (A); 4 (B); 5 (D); 6 (C); 7 (B)


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