Milwaukee Journal Sentinel reporter John Fauber deserves kudos for his dogged reporting on some unsavory practices in the medical profession. It was especially nice to see his latest piece—so refreshing and so different from the doctor stories the press has been feeding us lately. You know, the ones about physicians whining and wailing that Congress hasn’t yet agreed to ditch a scheduled Medicare fee cut.
Fauber tells the tale of Dr. Richard Page, who co-authored a paper last year about an international study of a new drug for treating atrial fibrillation—an irregular heartbeat—that led to FDA approval of Multaq, a mega-buck hit for its maker, Sanofi-Aventis. In Milwaukee, one Walgreens drug store was selling it for about $3500 a year. Page, it seems, put his name on the paper, vouching for the accuracy and completeness of the study even though he had not seen or much less evaluated the raw data behind the conclusions it reached. And what was that conclusion? Multaq significantly reduced cardiovascular deaths, a finding published in the New England Journal of Medicine in early 2009.
Page, who chairs of the department of medicine at the University of Wisconsin’s School of Medicine, told the paper that it all comes down to trusting the drug company: “These companies, if they were falsifying data, wouldn’t be kept in business if that were found out. I was satisfied and remain satisfied that the study was conducted in an appropriate way.” Page and his other co-authors all had financial ties to Sanofi-Aventis when the study was conducted. Page, who worked at the University of Washington when the study was done, said that his work as a paid consultant ended in May 2008, when he became president of a medical society that did not allow financial connections to the drug industry.
This is the kind of reporting that’s hard to do. It takes time to piece together information on clinical trials, understand what’s missing from the results, and find the discrepancies in the data. In this case, there were lots of questions. Shortly after the New England Journal published the Multaq study, an FDA advisory panel met and criticized the claim that the drug significantly reduced deaths from cardiovascular disease. In fact, Fauber reported that, even before it hit the market, Multaq had been linked to serious problems. Another trial, conducted in 2003, had to be stopped because more patients taking the drug were dying than those taking a placebo.
He also pointed out that the FDA later got its hands on the unanalyzed raw data and did its own analysis. He read the transcript of the FDA advisory panel meeting and talked to members of the committee who raised questions about how the study was conducted, not about falsifying data. One member told him that the study originally included 4300 patients, but that those subjects didn’t show there was a “significant benefit in reducing cardiovascular deaths.” The trial was then expanded to include 328 more patients, and this time the study showed five deaths among participants in the placebo group and one in the Multaq group. Fauber told readers that finding—considering the additional sample—was apparently sufficient in the eyes of the company’s researchers to report a significant benefit. But one member of the committee said it was improper to change the rules in the middle of the game.
When Fauber asked Page about this, both he and the study’s lead author, a German doctor, refused to comment. That’s another problem covering these kinds of stories. Tight-lipped and thin-skinned docs are an occupational hazard, and often their propensity to stonewall deters even the best reporters.