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.
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The Constant Gardener is a riveting movie on drug "trials." I saw it several years ago and watched it again during the faux health care debate when Obama made his deal with Tauzin.
btw, for those who may not realize this - prescriptions from Canada cost about half to a third what they cost here. The same holds true for over the counter products, many of which are made by the same companies as in the USA. As for generics and brand, you can find them made in Canda, the UK or in other countries and choose what you want according to country of origin or cost. The regs used by manufacturers in other countries are very tight and probably more strict than the FDA in countries which are trying to become part of the industry.
Many Americans may not realize that the generics (and brands) they are purchasing at their local CVS or other pharmacy are not made in this country.
The majority of customers from America are seniors who have reached the donut hole which has barely been touched by Obamacare in spite of the big deal made by Congress and the president recently when the checks for $250 were mailed.
And, of couse, Canadian pharmacies are the perfect place for Americans who are uninsured or who have catastrophic plans with no RX coverage. The meds aren't cheap but certainly not completely unaffordable as they are in this country, and for many, this is a virtual lifesaver!
No one in Canada is dropping dead in the streets just like people in France aren't dropping dead from raw milk cheeses which are barely allowed to be imported into this country.
#1 Posted by dianne, CJR on Sat 19 Jun 2010 at 01:53 AM
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The Milwaukee Journal Sentinel’s John Fauber missed the mark in his recent investigative series on physicians’ conflicts of interest when he hit hard at the University of Wisconsin School of Medicine and Public Health in Madison, Wisconsin (UW) but failed to report on any possible physicians’ conflicts at the Medical College of Wisconsin in Milwaukee (MCW).
When he ignored the Medical College of Wisconsin, Fauber also failed to disclose his own conflict of interest that involves the MCW.
Steven J. Smith, chair and CEO of Journal Communications, the company that owns and operates Mr. Fauber’s newspaper, also is the immediate past chair of the board of trustees at the MCW, a private medical school in Milwaukee. Mr. Smith served on this board from May, 1998 through May, 2010, according to a spokeswoman I talked to at MCW. Of the 22 Fauber stories on the subject that I read, posted on Journal Interactive, all but three were published before May, 2010.
Contributor Trudy Lieberman says that the Fauber series on heart medication “reminds me of certain conflicts – hidden and not so hidden – in medicine . . .” Some of Mr. Fauber’s stories have indeed shed light on potential problems involving how conflicts of interest in medicine are identified and managed.
However, in Mr. Fauber’s first two articles of the series, he mentioned that the Medical College refused his request for outside activity reports for its physicians. Curiously, although conflicts of interest are a nationwide issue among all medical schools, not one of the Journal Sentinel’s subsequent stories revealed Mr. Smith’s dual roles and the conflict they pose for the newspaper.
It is ironic that Ms. Lieberman also said, “Tight-lipped and thin-skinned docs are an occupational hazard, and their propensity to stonewall deters even the best reporters,” when all MCW doctors stonewalled Mr. Fauber through MCW Dean and Executive Vice President Jonathon I. Ravdin.
The existence of this conflict would be enough to raise the eyebrows of any seasoned reporter. The Journal Sentinel’s readers deserve to know that it exists so they can reach their own conclusions about whether it affected the paper’s coverage of the topic.
This disturbs me as a former Wisconsin newspaper editor and former investigative and government reporter. I should reveal that I also have a conflict in this matter, because I am married to an employee at University of Wisconsin Hospital and Clinics, whose staff works with employees of the University of Wisconsin School of Medicine and its foundation, a target of Mr. Fauber’s series. This is how I learned of the Journal Sentinel’s conflict and did some checking of my own.
In her letter, Ms. Lieberman describes Mr. Fauber’s work as “dogged” and his reporting as “hard to do.” A more accurate interpretation might be that Mr. Fauber has taken the path of least resistance. He focused on UW, a public organization that must comply with open-record requests and he ignored the MCW, an organization in his own backyard. The University of Wisconsin-Madison, of Which UW Hospital and Clinics is a part, has been a strong supporter of the federal Sunshine Act that would create a level playing field for all physicians on the matter of conflicts of interest.
Journalists ought to abide by the same ethical standards by which they judge others. Ms. Lieberman would serve her journalism colleagues well by examining the story fully.
Dean A. Showers
5102 Regent Street, Madison WI 53705-4748
608-236-0292
lisadean5@sbcglobal.net
#2 Posted by Dean A. Showers, CJR on Thu 29 Jul 2010 at 10:31 AM