12:00 AM
 | 
Jun 04, 2007
 |  BioCentury  |  Politics, Policy & Law

Avandia and 9/11

This Wednesday's congressional hearing on GlaxoSmithKline plc's Avandia rosiglitazone will showcase escalating if not demagogue-like criticism of FDA's drug safety oversight, which has been given new life by cardiologist Steven Nissen's selective meta-analysis of small clinical trials that he downloaded from the Internet.

FDA previewed its defense last week, arguing it has acted responsibly in the face of inconclusive data, and GlaxoSmithKline attempted to refute Nissen's analysis. But neither made much headway as the media focused on reports of Avandia's shrinking market share and gave voice to comparisons between the drug and the 9/11 attacks.

The storm broke on May 21, when The New England Journal of Medicine published the meta-analysis by the Cleveland Clinic's Nissen and Kathy Wolski that concluded there is an association between the diabetes drug and an increase in the risk of myocardial infarction and death from cardiovascular causes.

Congress - but not FDA - was tipped off about the publication in advance. Foreknowledge allowed congressional staff to roll out a choreographed response designed to breathe new life into efforts to separate the assessments of drug safety and efficacy (see BioCentury, May 28).

Although GlaxoSmithKline (LSE:GSK; GSK, London, U.K.) had published data similar to Nissen's analysis on the Internet and turned it over to regulators in the U.S. and Europe, in conversations with BioCentury and other news media, Nissen and the co-authors of an accompanying NEJM commentary accused GSK of hiding negative safety data to preserve its profits.

Those expecting the storm to ebb over the long Memorial Day holiday weekend in the U.S. were mistaken. On Tuesday, a note from Deutsche Bank analyst Mark Purcell cited prescription data that he said indicated a "major market share loss in just 2 days" since the NEJM publication.

"Data from ImpactRx suggests that the 21 May NEJM (New England Journal of Medicine) article has resulted in a reduction of Avandia's market share of the newly prescribed oral anti-diabetic (OAD) market to approximately zero," Purcell said in the note.

ImpactRx, which tracks how pharmaceutical promotion affects prescribing behavior, issued a press release later on Tuesday calling the analyst's conclusions "premature."

GSK agreed. "It's too early to draw conclusions about market share," said spokesperson Mary Rhyne. "We hope patients will wait for more scientific answers," before making any decisions about their diabetes drugs.

The rhetoric became more inflamed on Wednesday, when ABC News posted a video trailer for Nissen's upcoming Thursday appearance on the network's Nightline program.

Nissen led off the clip by telling the interviewer: "You have to understand what's involved here. We lost three thousand of our citizens on 9/11. Some people in the next few weeks are going to be calculating the potential number of deaths related to a drug like Avandia, and it dwarfs the events of 9/11, something that caused a revolution in this country. So it's time to fix this problem."

Softer drumbeat

Although...

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