Will CME providers be included in the Sunshine provisions of health care reform? The Wall Street Journal looked at the question recently. The final House health reform bill includes CME providers and other third-party medical groups among the covered recipients whose payments from the pharmaceutical and medical device industry would be publicly disclosed—language referred to as the Physician Payments Sunshine provisions. The Senate Finance bill that is being merged now with the HELP committee  also contained Sunshine provisions, but did not include third-party groups.

Yet representatives of industry-backed CME in Washington whom the Journal spoke to seem to understand that good transparency means broad transparency, and that broad transparency is becoming a requisite for credibility in the medical education industry.

Indeed, since the Sunshine Act was introduced in January 2009 as a stand-alone bill that would require drug and device companies to disclose all payments to doctors and others, acknowledgment of a need for national medical transparency standards has gained wide acceptance. The Institute of Medicine and the Medicare Payment Advisory Commission have both recommended that third-party medical groups like CME providers be among those whose payments from industry should be disclosed; the IOM called for an end to all company support of such education programs within two years. As the Journal points out, companies such as Pfizer and GlaxoSmithKline have stopped direct support of for-profit third-party CME providers.

–Kate Petersen, PostScript blogger

Pew Prescription Project Director Allan Coukell addressed the FDA this morning as part a two-day public hearing on the promotion of drugs and devices on the internet and social media.

The agency is seeking public input on how pharmaceutical and medical device companies interact on the internet about FDA-approved medical products.  Anticipation of the hearings has run high, as pharmaceutical and medical device presence on the internet has expanded greatly in recent years and warning letters from the agency in April have left industry and consumers clamoring for more clarity on how existing FDA marketing regulations apply in the online world.  We were among them, filing petitions to the FDA last December over a series of YouTube videos that violated marketing regulations.

Coukell’s comments were part of RxP and Community Catalyst’s joint submission to the FDA. Here’s the full docket, or you can watch a live stream of the hearings.

–Kate Petersen, PostScript blogger

Medical device maker Boston Scientific is under investigation for its payments to doctors — and for payments to charities with whom those doctors and their families are affiliated. The company reported in an SEC filing that it has received subpoenas for the information from the HHS Office of the Inspector General. The company is also being investigated by the Department of Defense and the Army “concerning sales and marketing interactions with physicians” at an Army medical center in Tacoma, WA.

Boston Scientific’s marketing practices have been under scrutiny before. Last year, it was one of three companies investigated by the U.S. Attorney for marketing of defibrillators and pacemakers. This week, the company paid $296 million and plead guilty to charges of two misdemeanors resulting from that case.

Interestingly, at an industry conference in Washington, D.C. this week, an employee of one device company explained that his company was being asked by doctors to direct payments to “third-party entities.” Would the Sunshine Act require disclosure of the ultimate recipient? Yes, he was told, it would.

Here’s the full post.  Hat tip to Pharmagossip.

–Kate Petersen, PostScript blogger

We’ve been hearing a lot about how pharma companies are curbing their spending on speakers bureaus, the practice of companies paying physicians to give drug-geared talks to other physicians.  Just this week, Pharmalot reported on a survey that showed 71 percent of drugmakers say they have established annual compensation caps on what they will pay individual physicians, many focused on the speaking engagements. The caps, Pharmalot reports, vary widely between companies: $10,000 to $100,000 per physician per year.

And then, there was the ice cream incident earlier this fall, where some companies – notably Schering-Plough — made a showy point of keeping refreshments out of the hands of doctors at a Boston convention, suggesting the Massachusetts gift ban and disclosure law enacted this summer had ended an era of unnecessary marketing to doctors, and ushered in a new one of thorough, if exaggerated, compliance.

But from the looks of this photo, sent in by an alert reader at Logan International Airport in Boston this week, such voluntary caps and Massachusetts’ gifts and disclosure law may not be curtailing physician marketing payments like speakers bureaus as much as industry would like us to think  — at least not at the arrivals gate.

–Kate Petersen, PostScript blogger

Two stories in the New York Times today look at the payments made to physicians by the pharmaceutical and medical device industry, and what provisions in the health care reform bills might do to illuminate those ties.  The Times notes AdvaMed’s support for the Senate bill.

Using Eli Lilly’s court-ordered faculty registry, the Times focuses on an adjunct professor of psychiatry at Stanford University, Dr. Manoj Waikar, who participates in advisory roles and speakers’ bureaus of four major drug companies. At fifty-one speaking events and nearly $75,000, Dr. Waikar was one of Lilly’s top five earners in the first quarter of this year.

Some universities, including Stanford, prohibit such arrangements because of their marketing-based aims (physicians use drug company-proffered slides), but such limits often extend  only to full-time faculty, leaving adjuncts such as Dr. Waikar to serve multiple industry interests.

The WSJ Healthblog goes to a new Health Affairs article for a little perspective on the situation:

“Sometimes it seems like everybody has financial ties to the drug or device industry,” writes the Healthblog’s Jacob Goldstein. “As it turns out, it’s only a little more than half of everybody,” pointing to a new survey in Health Affairs that found 53 percent of life sciences academic research faculty had relationships with industry. The survey found that clinical researchers were significantly more likely to receive industry funding than non-clinical researchers.

So what’s a top school? The survey, conducted in 2007, was mailed to more than 3000 researchers at the 50 U.S. universities that receive the most funding from the National Institutes of Health, a common metric used to measure research status.

–Kate Petersen, PostScript blogger

Modern continuing medical education (CME)  suffers from some of the same problems Abraham Flexner laid out in his report on undergraduate medical education nearly a century ago, according to a new paper in JAMA.

Researchers Eric Campbell and Meredith Rosenthal argue that the current CME system is hampered by excessive commercialization, unstandardized curricula, and lack of effect on patient care, three weaknesses the Flexner report identified. They argue that the the report, which shaped 20th century medical education, can be a similar catalyst  for needed CME reforms today.

The authors point to recent reports by the Institute of Medicine and Robert Steinbrook on the problem of heavy reliance on industry funding, which supports more than half of all CME in the U.S. and sports a 23.5 percent profit margin — and suggest that such reliance has caused a narrow, product-focused model that ignores important health issues and alternate therapies. They write:

Reorienting CME toward the goals of health system reform and away from marketing drugs will require a new system of funding with increased contributions from individual physicians, hospitals, and other sources.

Payment reforms should incentivize quality, efficient patient care, the authors say, and as such, physicians  should be financially responsible for a greater share of their CME.  In addition, they recommend that licensure requirements should be bolstered and formalized, and technology better used to measure effects of continued learning on patient care.