| May 21, 1999 |
FDA approves Vioxx (Rofecoxib),
a new drug for the treatment ofosteoarthritis, menstrual pain and
for the management of acute pain in adults. Merck initiates very
aggressive direct-to-consumer advertising campaign. |
| February 8,2001 |
The FDA Arthritis Advisory Committee meets to discuss concerns
over cardiovascular risks associated with the use of Vioxx. |
| May 22, 2001 |
In the wake of studies that clearly
demonstrate concerns over the cardiovascular safety profile of
Vioxx, Merck publishes a significant press release titled "Merck,
Sharp & Dohme Reconfirms Favorable Cardiovascular Safety of Vioxx,
Emphasizes Powerful Pain Relief" |
| July 11, 2001 |
The Vioxx package insert is updated for the second time. |
| September 17, 2001 |
Merck receives its strongest FDA warning
letter to date. The warning letter specifically addresses Dr.
Holt's videoconferences, Merck's press releases, and its unfounded
and illegal claims of product safety. The FDA cites Merck for
minimizing potentially serious cardiovascular findings and of
misrepresenting the product's safety profile. |
| August 29, 2001 |
An article entitled "Risk of Cardiovascular Events Associated
with Selective Cox-2 Inhibitors", was published in the Journal of
the American Medical Association, setting out the risks associated
with Cox-2 selective inhibitors. |
| April 11, 2002 |
The FDA instructed Merck to include certain label precautions
for cardiovascular risks. |
| April 11, 2002 |
Media sources, report that Merck spends in the neighborhood of
$15-16 million a month on direct-to-consumer advertising. It is
understood that even more is spent detailing physicians with
information recognized by the FDA to lack fair balance and to
overstate the safety profile of Vioxx. |
| 2003 |
Merck finances a study that concludes that Vioxx increases the
risk of heart attacks and strokes. Even though financed by Merck
the company still disputes the results of the study and does not
remove Vioxx from the market. |
| August 2004 |
Kaiser Permanente studies 40,500 patients and concludes that
those patients taking Vioxx experienced three times as many heart
attacks and sudden cardiac deaths than those patients taking
Celebrex. |
| August 27, 2004 |
Merck states that it strongly disagrees with the conclusions
of the Kaiser Permanente study. and still does not take Vioxx off
the market. |
| September 2004 |
Only a month after Merck disagrees with the Kaiser Permanente
study, the FDA reports that patients taking Vioxx chronically face
twice the risk of a heart attack compared to patients receiving a
placebo. Merck finally agrees voluntarily to withdraw Vioxx from
the market. Merck’s stock price plummets 25%. |
