Thursday, July 15, 2010

Duelling Studies

The past few weeks I've been monitoring the news on Avandia, the glucose lowering drug for Type 2 diabetics produced by GlaxoSmithKline. The drug does indeed do a good job at lowering blood glucose, but it also has some nasty side-effects, including an increased risk for strokes, heart attacks, and heart failure in, according to some of the studies produced at an FDA advisory panel meeting, up to a third of those using the drug.

After reviewing the studies presented, that advisory panel sent a mixed recommendation to the FDA, which will make the final decision on the drug in the near future.

Faced with conflicting and less-than-conclusive scientific evidence, a Food and Drug Administration advisory panel recommended Wednesday that the controversial diabetes drug Avandia remain on the market — but with tighter supervision and increased warnings about the danger of heart attacks. ...

Reflecting the difficulty of balancing potential risks and benefits for individual patients, 10 members of the 33-member panel voted to keep Avandia on the market under close supervision, seven voted to permit continued marketing but with stronger label warnings, and three favored the status quo. One member abstained. Twelve members voted to remove the drug from the market.

What is so refreshing about the whole process is that this time it was played out in full view of the American public. Most, if not all, of the major newspapers covered the story. My brief and admittedly incomplete scan of today's editions shows that the Boston Globe, Los Angeles Times, New York Times, and Washington Post all had stories, columns, and/or editorials on Avandia. The Los Angeles Times and New York Times have been following the Avandia saga for quite a long time, given the usual short attention span of today's media.

And that coverage has had an effect: prescriptions written for Avandia have dropped over the past few years:

At the peak of its popularity in 2006, 13 million prescriptions were written, according to IMS Health, a pharmaceutical market research company. By 2009, the number had declined to about 2.6 million, the firm said. GlaxoSmithKline, the drug's maker, said about 550,000 Americans took medications containing Avandia in the last year.

Dr. Jacob Warman, chief of endocrinology at the Brooklyn Hospital Center in New York, said he expected use of the drug to drop further.

"There is so much negative press that lay people are going to say, 'Why are you giving that to me? Why don't you give me the other drug?' Doctors are not going to fight the patients," he said.

"It's not officially dead in the water, but practically speaking, it should be," he added.

In other words, the press has done its job, and done it well with respect to educating the public and offsetting the millions of dollars of pharmaceutical advertising.

Just as important, however, is the fact that the press has also brought some pressure to bear on the Food and Drug Administration. When it comes to Avandia, the FDA doesn't dare ignore the studies and recommendations from its own panel by simply rubber stamping the manufacturer's assertions of safety. Here's how an editorial in today's NY Times put it:

The clearest lesson to emerge from the hearings and other recent revelations is that GlaxoSmithKline, the maker of Avandia, can’t be trusted to report adverse clinical results fairly. The company must be watched like a hawk as additional trials that it sponsors go forward.


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