"The diabetes specialists have a very big problem with cognitive dissonance," he says, in that they have to justify why they have been prescribing Avandia. "A cardiologist tells them this drug is dangerous, and no doubt that there is some pushback. But I believe the results we have reported will stand the test of time."
Source
Meanwhile, Bloomberg report a nice quote of their own in a great piece of investigative journalism:
As far back as April 1999, executives of SmithKline Beecham Plc, which a year later merged with GlaxoWellcome Plc to become GlaxoSmithKline Plc, told the FDA that Avandia caused ``minimal'' cardiovascular side effects and ``mild to moderate'' fluid buildup. Fluid in the lungs or bloodstream can increase the heart's workload.
The agency cleared the drug for sale the next month. Some advisory committee members called for more research on potential complications.
In February 2001, after the drug was on the market, Glaxo agreed to an FDA request to change the drug's prescribing label to warn doctors that Avandia, like other drugs in its class, can cause fluid retention.
Company sales representatives who knew the risks ``denied their existence'' three months later in oral presentations at the American Association of Clinical Endocrinologists' meeting in San Antonio, Texas, FDA officials noted in a July 2001 letter to Glaxo.
FDA Criticism
The FDA told Glaxo in that letter that its marketers should stop denying or minimizing the increased risk of ``heart failure or other cardiovascular adverse events'' in patients taking the drug with insulin, according to the FDA's Web site. The agency criticized Glaxo for continuing to ``engage in false or misleading promotion of Avandia.''
Analysts at Citigroup Inc. and Morgan Stanley had noted possible cardiovascular side effects in notes to investors last year.
``The key issue in addition to at least equivalent efficacy of Avandia to metformin and glyburide is cardiovascular safety,'' Citigroup analysts wrote in a Nov. 23 report.
The next month, as results of a large-scale, company-funded trial were published, Glaxo executives said the overall risk of death, heart attack and stroke with Avandia was similar to other diabetes medicines.
Diabetes researcher Rury Holman of Oxford University in the U.K., an investigator in the $100 million company study, known as ADOPT, said in a Dec. 3 interview that the results would cause concern.
`We Can't Deny'
``These people are early diagnosis, they haven't got complications,'' Holman said. ``The fact that we're seeing these cardiovascular effects in them, we can't deny that. The concern when these data come out is you've got relatively healthy patients and still there's a little bit of a signal.''
No comments:
Post a Comment