The British Medical Journal (BMJ) today raised more questions about whether diabetes drug Avandia should ever have been approved for patients in the United States and Europe, and whether the drug “may be about to fold.”
Pharmalot blogger Ed Silverman summed up the Avandia activity: “The UK’s Medicines and Healthcare products Regulatory Agency says the GlaxoSmithKline drug ‘no longer has a place on the UK market.’ The chair of the European Medicines Agency scientific advisory group on diabetes argues the pill should be withdrawn. And the same sentiment is expressed by the BMJ, a leading medical journal, in an editorial that accompanies an investigation into regulatory footdragging.”
Meanwhile, Avandia’s maker, GlaxoSmithKline plc, tried to get ahead of a BBC Panorama report this evening that is expected to be critical of the drug’s safety and may alarm patients.
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A decade ago, rosiglitazone was heralded as a first-in-class drug to lower blood sugar in diabetic patients. But its image began to suffer after a well-publicized report in 2007 by Cleveland Clinic cardiologist Dr. Steven Nissen, studies on tens of thousands of patients, and a negative analysis of a European safety trial raised questions about its heart safety.
The 2007 meta-analysis by Nissen and his Cleveland Clinic colleagues concluded, “Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance.”
The Nissen report led to a Congressional inquiry, stringent safety warnings, a sharp drop in the drug’s sales and a plunge in GlaxoSmithKline share price, according to the New York Times.
GlaxoSmithKline has staunchly defended its drug.
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“GSK has carried out an extensive research programme involving more than 50,000 patients to analyse the safety and benefits of rosiglitazone,” the British company said in its response to the medical journal analysis. “No other diabetes medicine introduced in the last 10 years has such an extensive safety database.”
In mid-July, a U.S. Food and Drug Administration advisory panel completed two days of hearings on Avandia, narrowly agreeing to allow the drug to stay on the market, despite its risks. In 2000, the European Medicines Agency had done the same after hearing results of the European study, called RECORD, conducted by GlaxoSmithKline.
“Taken together, the data from these types of trials have shown that Avandia does not increase the overall risk of heart attack, stroke or death compared to other diabetes medicines,” GlaxoSmithKline said in one of its statements today. “We continue to believe that Avandia is safe and effective when it is prescribed appropriately.”
But in an editorial published today, British Medical Journal Editor-in-Chief Fiona Godlee says the diabetes treatment should be withdrawn from the market and should never have been approved, Bloomberg BusinessWeek reported.
According to today’s analysis of the drug and its history in the medical journal: “It was, as one Food and Drug Administration (FDA) adviser put it, a ‘perfect regulatory storm’ — a combination of problematic data, uncertain clinical need, politics, and poor drug company behaviour.” The journal goes on:
But the story reflects badly on almost everyone involved: the regulators, the manufacturer, GlaxoSmithKline, and the clinical community. It has also raised a host of questions. Why did the regulators accept such poor evidence on benefit and safety for rosiglitazone? Did GlaxoSmithKline mislead the regulators? Should the drug have been licensed in the first place and should it now be withdrawn? Why haven’t patients in the UK and Europe been made aware of the concerns about rosiglitazone’s effects? And is the current drug regulatory system up to the job?
Nissen’s analysis was published in June 2007. A month prior to the publication, the Clinic cardiologist surreptitiously recorded three GlaxoSmithKline leaders with whom he met over the drug.
One of the leaders was Lawson MacCartney, senior vice president of World Wide Development. “I’m responsible for GSK’s cardiovascular metabolic portfolio,” MacCartney said on the rec0rding.
The New York Times revealed the details of Nissen’s meeting with Glaxo executives in a Feb. 10 story.
Today, the British drug maker released the recording at its Web site, saying it had to subpoena Nissen to get it. Glaxo posted the recording in anticipation of the BBC report. “The company has taken this action so that all interested parties can hear all the comments made at this meeting in their full context,” it said in a release.
