July 26, 2010: Panelist Paid By Glaxo
On July 19th,
2010 an article in the Wall Street Journal reported that one of the panelists
who voted in favor of the diabetes drug Avandia at a Food and Drug
Administration advisory meeting the previous week is a paid speaker for the drug's
maker, GlaxoSmithKline PLC. Dr. David Capuzzi was one of only three experts who
wanted the drug to stay on the market with no additional warnings or
restrictions. The panel voted 20-12 to keep Avandia on the market, though most
of the members wanted stronger warnings. Dr. Capuzzi explained that he was
worried that if Avandia was pulled of the market patients would assume the
alernative, Actos, is safe. The FDA made a statement saying that it screens all
the financial ties of advisory-committee members and is looking into the
situation. FDA officials had stated before the meeting that they wanted to
avoid any questions about conflicts of interest. Dr. Capuzzi said one reason
for his vote was concern that another drug that works similarly to Avandia, called Actos, might also
have safety problems. Many panelists in favor wanted either tighter prescribing
restrictions or more warnings about cardiovascular risks. Avandia was approved
in 1999 as a medicine to lower blood sugar in diabetics but has garnered attention
from the FDA after a series of studies linked the drug to an increased risk of
heart attacks. Glaxo has said Avandia is
safe and should stay on the market. The committee members voted
overwhelmingly that Actos poses fewer heart-attack risks than Avandia.
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