After having spoiled any chance of a "successful sales celebration party" for AZs' Crestor (rosuvastatin) Public Citizen seem to be lining up their next target: GSKs' Serevent (salmeterol).
In a letter in this weeks Lancet, Public Citizen Director Sidney Wolfe and Deputy Director Peter Lurie accuse GSK of manipulating data from the SMART trial. SMART was started in 1996 to study asthma patients who received either Serevent or placebo. The study ran for 28 weeks and showed a raised risk of asthma-related death (possibly especially in African-Americans) for those taking the drug.
GSK also have a response letter, from their delightful Kathy Rickard, which refutes the PC allegations.
http://www.bloomberg.com/apps/news?pid=10000102&sid=aNSzwcqOPjY0&refer=uk
The timing for this broadside is a smart move (pun intended) by Public Citizen as Health Canada have just issued an advisory warning about salmeterol and the other long acting beta 2 agonists, based on the SMART results.
An FDA expert committee has voted for the drug, but the final FDA decision is awated.
http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_107_e.html
Serevent was identified by FDA whistleblower David Graham last November as a drug that needed additional warnings, when he testified to a U.S. Senate Finance Committee hearing.
Have a look at the SMART trial yourself on GSKs' trial database:
http://ctr.gsk.co.uk/Summary/salmeterol/studylist.asp
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