> 70% are preventable (Pirmohamed et al, BMJ; 2006)
Birth of Vigilance
Thalidomide was sold from 1956 to 1962 in almost 50 countries
Prescribed to pregnant women, as an antiemetic
From 1956 to 1962 ≈ 5,000 in Germany and 10,000 children in Europe, Australia & US were born with severe malformations.
1998-FDA approved for lesion associated –Erythema nodosum leprosum.
2006- Multiple myeloma
2007- approved for leprosy
504 million $ Sales.
Vioxx safety data manipulated In Sep 2004 Merck publicly announced its voluntary withdrawal of the drug vioxx a 2.5 billion $ seller from the market worldwide. Drug companies has been found to have suppressed and manipulated certain critical data that misled the regulatory body — U.S.FDA. Journal of the American Medical Association confirms that the Merck was well aware of its dangers even before it withdrew the drug in 2004
MERCK ORDERED TO PAY COMPENSATION TO VIOXX USER
FDA analysts estimated 139,000 heart attacks, 30 to 40 % fatal (marketted 5 years).
>16, 000 cases relating to Vioxx are scheduled in federal Courts in the US.
A Texas jury -- liable for the death of a man who took the painkiller Vioxx, $253.4 million in damages.
2007 Nov, reached $ 4.85 billion settlement .
FDA panel concluded (Feb 05) Vioxx, Celebrex and Bextra ( April 2005 Pfizer withdrew ) all pose heart risks but should be available to consumers.
Should carry a so- called ''black box'' warning label about cardiovascular risk.
Merck & Co wins Vioxx court case, dismisses meta-analysis claim 24 November 2009
Real Lesson from Vioxx
There is always a need to link evidence to decision and decision to action.
E.g. the signal indicating that Rofecoxib is associated with MI could be confounded by the age group or concomitant illnesses of patients treated.
The decision to take action should be based upon the level of certainty of the signal and its seriousness.
In the rofecoxib situation a limited warning was quickly given. The kind of regulatory decision should obviously be based on what is reliably known at the time
Real Lesson from Vioxx
Communication of Decisions
The information should be ethically and effectively communicated.
Education in the appropriate use of drugs, including interpretation of safety information is essential for the public.
All the evidence needed to assess and understand risks and benefits must be openly available.
The Vioxx situation was not a failure of regulation itself, neither was it an issue of data collection ( data manipulation ), nor of the quality of studies performed. It was and is a complex decision-making/communication challenge in which improvements are possible.