GlaxoSmithKline, the manufacturer of the controversial drug Avandia, is pressuring plaintiffs’ lawyers to pull advertisements that educate consumers about possible complications linked to the diabetes medication. The company contends that ads that link Avandia with an increased risk of heart attack are “misleading”, but many of these ads simply echo the findings of a recently published Avandia study.
Avandia has been a subject of controversy since May 21, when an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. Recently, both GlaxoSmithKline and the Food & Drug Administration (FDA) have come under fire for an apparent failure to warn the public about the cardiac risks associated with Avandia. Testimony at a congressional hearing in early June revealed that the company and the FDA had known about the heart attack risk as far back as September 2005. However, both the agency and the manufacturer felt that more investigation was needed before conclusions could be made about Avandia’s possible safety issues. As a result, the cardiac problems were not made public until the Cleveland Clinic published its analysis in May.
Glaxo’s move against attorneys could be an attempt by the company to mitigate the financial impact of the Avandia controversy. Prior to the release of the Cleveland Clinic study, Avandia was Glaxo’s second highest selling medication. In 2006, it generated $3.3 billion in sales. Since the controversy over the medication’s heart risks made headlines, prescriptions of Avandia have plunged. Global sales of the drug have dropped more than 23-percent, and some analysts believe this will impact Glaxo’s earnings by as much as $200 million.
Lawyers in the US are allowed to advertise their services, provided they do not include misleading or false claims in such advertisements. Glaxo claims that the ads they are objecting to are “stating conclusively” that Avandia is linked to heart attacks. Glaxo insists that the Cleveland Clinic’s findings are not conclusive, as it only looked at a small number of patients. Glaxo claims that studies it paid for were far more comprehensive and found no increased heart attack risk.
But the Cleveland Clinic study is not the only time Avandia has been called into question. An independent analysis published by German researchers just last week concluded that Avandia was no better than older oral medications at reducing blood sugar, and those patients taking Avandia were more likely to gain weight and develop edema. There has also been a sharp rise in the number of Avandia side-effect reports since the Cleveland Clinic study made news. Since May 21, 90 heart attacks with possible links to Avandia have been reported to the FDA. In the 35-day period before the Cleveland Clinic study was made public, there had only been 5 such reports. Likewise, reports of heart-related hospitalizations among Avandia users also spiked. There were only 11 such cases immediately before the study was published, but after publication these reports rose to 126.
The clamor around Avandia has created so much controversy that the FDA has decided to convene an advisory panel to look at the drug’s safety problems. Those hearings are scheduled to begin on July 30.
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