I have written before on the culture of denial about the dangers of SSRI medications in the psychiatric and medical professions. This culture of denial is also rampant within the pharmaceutical industry. It could be argued that because this culture of denial emanates from the industry, thus by association this mindset infects and contaminates the medical profession; which itself is an industry that relies on the pharmaceutical industry for support and funding. Note how the behavior of GSK, in regards to its dangerous diabetes drug Avandia, evokes the scandal of Seroxat. GSK’s long history of bad pharmaceutical practice is all too evident and all too clear. It seems that the culture of denial, suppression of data, intimidation of critics, corruption, spin and the corporate agenda is the GSK norm. Would you trust any of GSK’s products? When you consider the sheer volume of bad press this company has generated for itself over the past 20 years, would you trust their medicines?
WASHINGTON—One of the panelists who voted in favor of the diabetes drug Avandia at a Food and Drug Administration advisory meeting last week is a paid speaker for the drug’s maker, GlaxoSmithKline PLC, according to the company and its records.
The panel voted 20-12 to keep Avandia on the market, though most of the members wanted stronger warnings.
Endocrinologist David Capuzzi of Philadelphia confirmed that he has been on Glaxo’s speakers bureau for several years and said he doesn’t see the relationship as a conflict.
I have not given any talks [to doctors’ groups] promoting Avandia,” he said in an interview. He said he spoke on behalf of another Glaxo drug called Lovaza, which can help lower triglycerides in the bloodstream that often lead to heart attacks.
Avandia, approved in 1999 as a medicine to lower blood sugar in diabetics, has been under fire because of a series of studies linking it to an increased risk of heart attacks. The two-day FDA meeting last week was closely watched by Wall Street and the industry because of its implications both for Glaxo and the agency’s stance on broader drug-safety issues.
Though the panel voted to keep Avandia on the market, 17 of the panelists in favor wanted either tighter prescribing restrictions or more warnings about cardiovascular risks. Dr. Capuzzi defended the drug during the meeting. He was one of only three experts who wanted the drug to stay on the market with no additional warnings or restrictions.
Glaxo’s website shows that he received $3,750 from the company as a speaker between April 2009 and March 2010. A Glaxo spokesman said Dr. Capuzzi also received about $8,000 in speaking fees from the company before that period and an additional $3,000 in the second quarter of this year, making the total payments about $14,750. The company has said Avandia is safe and should stay on the market.
None of the other panelists received money from Glaxo during the April 2009-March 2010 period, according to the company’s website.
Dr. Capuzzi said he told the FDA about his relationship with Glaxo. In a statement, the FDA said it screens all the financial ties of advisory-committee members and is looking into whether there was disclosure to the agency and, if so, why it wasn’t conveyed to the committee.
With so much at stake, FDA officials said before the meeting that they wanted to avoid any questions about conflicts of interest.
Dr. Capuzzi said that despite his vote he isn’t a fan of Avandia and uses metformin, an older diabetes drug, in his practice. He said one reason for his vote was concern that another drug that works similarly to Avandia, called Actos, might also have safety problems.
“The danger I worried about was that if we pulled Avandia, people might automatically switch to Actos and think it’s all hunky-dory,” he said. Actos maker Takeda Pharmaceutical Co. says its drug is safe; the committee members voted overwhelmingly that Actos poses few heart-attack risks than Avandia.
“In the middle of a firestorm over a drug, all connections to the company involved should be disclosed,” said medical ethicist Arthur Caplan of the University of Pennsylvania. Otherwise experts leave themselves “open to post-facto criticism and second-guessing,” he said.
One of the panelists who voted to keep Avandia on the market, cardiologist Arthur Moss of the University of Rochester Medical Center in New York, said he wished the FDA disclosed that Dr. Capuzzi spoke for Glaxo. “I’m surprised we weren’t told,” Dr. Moss said.