The Accreditation Council for Continuing Medical Education will publish a list of continuing medical education courses and companies that have violated its commercial bias standards, reports the New York Times. The accrediting group, which is supported by the type of  for-profit companies that provide more than half of all CME courses for U.S. physicians, has been accused of being slow to act on investigations of industry bias, and generally reluctant to take the proactive stances  on commercial bias that other professional groups have adopted over the last several years.

The Times points to the ACCME’s investigation of a CME program on atypical antipsychotics that was held up by psychiatrist Dr. Bernard Carroll on his blog, Health Care Renewal. Though the ACCME eventually concurred and the program was pulled from the web, CME watchdog Dr. Daniel Carlat has the slides over at Carlat Psychiatry Blog.

His take? This is biased, but I’ve seen worse. Carlat writes:

My point being that if the Atypical Antipsychotic program is bad enough to be pulled for commercial, my conservative estimate is that at least half, probably more, of all industry funded psychiatry CME will also need the retraction treatment. The problem is, who on earth has the time to police these things?… The best and simplest solution would be to end industry funding of medical education altogether.

Check out more PostScript coverage of CME and industry influence.

–Kate Petersen, PostScript blogger

Today, over at the PAL blog: the ban on pay-for-delay generic drug settlements which just passed out of the Senate Judiciary Committee, what it could mean for patients and insurers, and how the Senate and House versions would work.

Here’s more at Reuters.

By now you’ve probably read it: a study published in the New England Journal of Medicine today found that 3 in 10 orthopedic surgeons did not disclose financial arrangements they had with medical device makers – relationships that five device companies were required to disclose in online databases as part of a settlement with the U.S. government over illegal marketing. The authors compared the payments disclosed by the companies in 2007 to the disclosures required of presenters, committee members and board members at the 2008 annual meeting of the American Academy of Orthopaedic Surgeons. The free full text is here.

This is a big deal.  And it makes the crosscheck function of the Physician Payments Sunshine Act – which we’ve talked about here and here – seem more necessary than ever.  That’s because the Sunshine Act would basically set up a bigger version of what the device companies have done, a public online database into which drug and device companies would report annually.

This study suggests voluntary physician reporting is less complete than company reporting, and in the case of the orthopedists meeting, significantly so. The discrepancy represents $4 million in undisclosed payments related to physicians research. That’s a lot from a relatively small sample of the medical device industry (344 total payments), and it suggests there may be a lot more undisclosed payments out there.

“We were a little surprised at how high the nondisclosure rate was,” co-author Dr. Mininder Kocher told the Wall Street Journal.

So, how to account for such discrepancy? One common argument made is that disclosure policies and forms differ widely, creating confusion. Fourteen percent of respondents to a follow-up survey the authors gave the non-disclosing physicians said that they misunderstood the requirements.

But another argument we hear a lot when physicians have failed to disclose hundreds of thousands — sometimes millions – of dollars in company payments, is that it wasn’t relevant to the research at hand, the paper they were presenting, the treatment guidelines they were writing.  Merrill Goozner over at Gooznews digs in to this.

Looking at the follow-up study the researchers did, Goozner notes that this relevance argument is the main reason (about 40 percent) respondents gave for non-disclosure: the money that appeared on the devicemakers’ websites wasn’t relevant to their presentation.  But the NEJM study shows that one of five payments directly related to a presenter’s research still went undisclosed.

Besides, Goozner asks: “Is ‘relevance’ relevant?”  He doesn’t think so. “In my view,” Goozner writes, “it’s just a convenient excuse for not baring all and letting the reader/listener/reviewer decide. It’s time to get rid of the relevance dodge.

“For those steeped in the arcana of conflict-of-interest disclosure rules, the relevance test is one of the major bones of contention. If you consult for Pfizer, and talk about a drug from AstraZeneca, should you disclose your consulting gig? “Of course” is the easy answer since the companies compete on a wide range of products. But what if your consultancy is on a rare disease in which AstraZeneca has no product or development program?

“Those Talmudic distinctions offer an easy out for physicians on the payroll of drug and device firms, allowing them to hide some of their financial ties from editors at major journals and federal officials screening nominees for advisory committees. Their internal gavel comes down: not relevant, no disclosure required.

“The beauty of the court settlements in the device cases, as well as the Physician Payments Sunshine Act in the health care reform bills, is that they ignore the fine distinctions and opt for universal disclosure. But as this new study points out, even in the wake of having an easily accessible database, physicians will find reasons to avoid making those disclosures in public fora, whether in a printed article or before making a speech to an annual convention.

Check out a comparison of the Sunshine provisions in the health reform bills at the Sunshine Act Guide.

–Kate Petersen, PostScript blogger

From the under-the-radar-screen department:

While we noted Medtronic’s support of the Physician Payments Sunshine Act at its annual shareholders meeting back in August, we didn’t note a question from a shareholder on the scale of company payments to physicians.  In a question during the medical device company’s Aug. 27 meeting, one shareholder said he was shocked by the scale of payments made to doctors – payments that had been in the headlines during the recent Senate investigation of the $1.2 million Medtronic paid to University of Minnesota spine surgeon Dr. David Polly for consulting and honoraria.

The shareholder said he didn’t doubt that working with physicians outside the company was necessary. “But I and a lot of people are somewhat taken aback by the dollar amounts involved,” he said. “Is it really necessary to pay that kind of money to doctors in order to get good information?” The shareholder went on: how much could Medtronic even trust the information they were getting with sums like that?

“Obviously, nobody is going to want to tell you anything you don’t want to hear,” he said. You can listen to a recording of the full meeting here.

Medtronic’s chief executive officer Bill Hawkins responded by acknowledging the company entered into “service arrangements” with physicians, but suggested most of the payments in the news are royalties on patents. Well, there may be lots of those, but they aren’t the ones that have made the headlines. The ones in the headlines are like these, from the Star-Tribune’s account of Sen. Charles Grassley’s findings on Dr. Polly’s invoices to Medtronic:

“He billed to check e-mail, sometimes in 5-minute increments. He also billed to make phone calls; in 2006, there were roughly 125 calls. On April 30, 2005, he charged the company $750 for 90 minutes of “summarizing thoughts and opportunities” after a medical meeting. And on Feb. 12, 2004, he charged the company $350 to update his consulting log.”

Yes, it’s just one voice, but then again, maybe it’s not. We haven’t been in many shareholders meetings – are you hearing similar questions being raised by other investors? Send us a comment.

–Kate Petersen, PostScript blogger