The American Psychiatric Association has voted to end industry-funded CME offerings at its annual meeting, as well as to phase out meals from drug companies. The industry-sponsored symposia netted up to $1.5 million per year for the association, which is the first to take such a step.

Read more at the New York Times, Reuters, and The Carlat Psychiatry Blog.

Drugmaker GlaxoSmithKline has announced it will publicly report clinical trial payments to investigators and their institutions beginning in 2010. The announcement comes after the company’s initial pledge in October to disclose consulting payments to doctors and cap such payments at $150,000 per physician, per year. GSK joins Medtronic, Pfizer, Eli Lilly and Merck, which have each made pledges to some sort of voluntary disclosure.

The New York Times reported this week that the popular online quiz “RealAge” shares the names and results to drug companies, which pay RealAge to send personalized drug ads to targeted quiz-takers.   “While few people would fill out a detailed questionnaire about their health and hand it over to a drug company looking for suggestions for new medications, that is essentially what RealAge is doing,” wrote the Times. “It acts as a clearinghouse for drug companies, including Pfizer, Novartis and GlaxoSmithKline, allowing them to use almost any combination of answers from the test to find people to market to.”

In an editorial last week, JAMA issued a new policy for those who report undisclosed conflicts of interest. The editorial comes in response to a dispute between JAMA editors and two researchers who contacted the journal about an undisclosed conflict of interest by an author in the journal last year. After five months without hearing from JAMA staff, the researchers submitted a letter about the conflict to BMJ. After JAMA editors called one of the researchers, Dr. Jonathan Leo, and his dean in efforts to get him to retract the letter, they published this policy, which says that researchers who have discovered an unpublished conflict of interest in the journal should not contact any third party until JAMA has completed its own investigation.

The new policy has raised concern among some in the academic and medical publishing communities for its claims on public information and its potential silencing effect on those who discover conflicts of interest. Among them: Gooznews, Howard Brody and HealthCare Renewal.

Here’s the Wall Street Journal coverage.

The head of the American College of Cardiology, Dr. W. Douglas Weaver, argues on the Detroit Free-Press opinion page that a few bad apples are no reason to move away from drug company-funded continuing medical education.

“Industry needs physicians — we help develop new products, conduct clinical trials and prescribe products — and physicians need education.” But Weaver makes the questionable jump that these two facts together means that physicians need industry-funded education.

The Macy report on CME funding provides an eloquent rebuttal to that argument, better than we could do:

Companies with billions of dollars at stake cannot be expected to be neutral or objective when assessing the benefits, harms, and cost-effectiveness of their products, for they are in the legitimate business of gaining market advantage and want clinicians to use and prescribe their products….

Because of these underlying ethical issues, participants concluded that the commercial entities that manufacture and sell healthcare products should not provide financial support for the continuing education of health professionals.”

Still, Weaver writes “it will be critical to address conflicts of interest” with bills such as the Physician Payments Sunshine Act, which would require drug and device companies to disclose all payments to doctors in a public, online database.

And we bid farewell to Scott Hensley, the original Wall Street Journal Health blogger, who kept us in the know about the pharma and health care world with his incisive, quick-witted reporting. We’re sorry to see you go, Scott. Guess it’s time for us to learn to Twitter.

The American Medical Association seems to have taken a report recommending the end of industry funding of Continuing Medical Education (CME) off its website.  The recommendations, brought before the AMA’s Reference Committee on Amendments to Constitution and Bylaws by the Council on Ethical and Judicial Affairs (CEJA) last year, were unambiguous:

“Individual physicians and institutions of medicine, such as medical schools, teaching hospitals, and professional organizations (including state and medical specialty societies) must not accept industry funding to support professional education activities. Exception should be made for technical training when new diagnostic or therapeutic devices and techniques are introduced. Once expertise in the use of previously new devices has developed within the professional community, continuing industry involvement in educating practitioners is no longer warranted.

They have been replaced by this two-page update – “Industry Support for Professional Education in Medicine-Update”  — that urges CEJA “to more fully address potentially different implications for different stakeholders in medical education and to seek further input from stakeholders.” As reported earlier (see Carlat’s post), the Council has been assigned to work with Council on Medical Education to develop “complementary, companion reports,” and word is that industry funding will be OKed this time around.

Meanwhile, the AMA continues to defend the impartiality of industry-funded CME through an industry-backed task force it has housed for two decades. This Task Force on CME Provider/Industry Collaboration, whose annual conference was supported by Educational Measures, Medscape, Pfizer Inc., Pri-Med, Wyeth and a host of MECC exhibitors, is made up of “50 senior professionals from CME providers, grantor companies, and other industry organizations.” The task force has launched a campaign called “Get the Facts,” which seems aimed to reverse a growing sense in the profession that the independence of physician education is compromised by its overwhelming financial reliance on the pharmaceutical industry:

“The media, state and federal law and policy makers as well as regulators and other ‘collective/consensus opinions’ frequently use and disseminate information that can lead to incorrect assumptions and false perceptions about CME. This has led to increased regulatory scrutiny and critical public opinion regarding CME practices. Get involved! Help Get the Facts straight!”

UPDATE: We contacted the AMA and learned that the Get the Facts! Campaign was launched Oct. 22, 2008.

Massachusetts reached a significant milestone today in the effort to both measure and manage the extent of pharmaceutical and medical device marketing to prescribers.  The state’s Public Health Council today passed strong regulations that limit gifts and payments to prescribers, and disclose others, completing the  state’s enforceable code of conduct passed last summer.  The code, required to be at least as strong as the PhRMA and AdvaMed voluntary codes, is arguably the strongest in the nation; Minnesota’s first-in-nation gift ban does not apply to medical device companies; Massachusetts’ does. And unlike Minnesota’s standing law, the disclosure info will be posted on a public and easily-searchable database for consumers and researchers.

Among the highlights of the final regulations:

-DPH included trainees in the ban on direct payments for scholarships, CME, and other travel payments. This is a good news for the state of unbiased medical education at Massachusetts many academic medical centers.

-The Council had a good debate on prescription drug samples, and will do further study of the issue of samples as marketing tools and revisit the issue next year.

-DPH interpreted the $50 limit as a floor, meaning gifts under $50 not expressly banned in the law would not have to be disclosed. Since pens, pads, and tchotchkes are banned, this means that a lot of in-office drug lunches will fly under the radar.

-Bona fide payments to investigators for research will not have to be disclosed, but those payments for trials with marketing purposes, such as seeding trials, must be.

Seeding trials, if you’ll recall, are clinical trials whose scientific purpose is tenuous at best: “a marketing trial with a marketing objective,” in the words of the authors of a paper on the Vioxx ADVANTAGE seeding trial. Unlike other, scientifically rigorous clinical trials, seeding trials are primarily designed and carried out by marketing departments with the goal to get doctors to start using their drugs — kind of like beta-testing for gadgets and computer programs, or the little bags of free granola that come wrapped in the Sunday paper. Except with powerful, sometimes lethal pharmaceuticals.

An Internal Merck slide outlined the lead role of Merck’s marketing department in the ADVANTAGE trial:
•    Design protocol and oversee execution of trial
•    Select investigator sites
•    Run investigator meetings
•    Choose and manage CRO
•    Perform data analyses
•    Prepare publications

Historically, drug companies have not been upfront about what a clinically valuable trial and what is a seeding one – after all, what doctor or patient would sign up for a clinical trial that she knew was designed only to create product loyalty? The Council showed a good understanding of the complexity of the issue, and made it clear it that DPH and the Attorney General’s office will be actively seeking signs of such illegitimate trials and sanction companies that don’t disclose them.  And reports today of a Massachusetts-based investigator who fraudulently published 21 clinical trials on the use of painkillers like Celebrex for post-operative pain – studies funded by Pfizer – highlights anew the public interest in knowing a clinical trial’s legitimacy and money trail.

Requiring companies to report all research payments is the failsafe way to ensure such marketing-based trials are recognized and disclosed, and we would have liked to see the Council stand by that original standard. Still, we are encouraged by the Council’s recognition that the corporate marketing aims of seeding trials undermine safe and effective drugs for state residents.

As we prepare for the regs to go into effect July 1, we’ll explore, along with others, ways to identify seeding or other questionable trials in a way that is valuable to regulators who will be protecting Bay State patients by monitoring drug and device payments to doctors.

It was a big week for the AMSA Scorecard, which popped up in the New York Times story about Harvard Medical School’s extensive ties to industry and what some medical students and faculty are doing to bring them to light. The story topped the most-read column on the nytimes.com site for a few days and sent Sen. Charles Grassley back to his writing desk, where PostScript imagines he writes all his letters to wayward drug companies and non-disclosing academics. This time he wrote to Pfizer, asking for the details of payments to 149 Harvard medical school faculty revealed in the article, and for any information the company has on the amateur photos of a medical student rally at Harvard in November snapped by one of its employees.

Time magazine had this look at AMSA’s campaign to get prescription drug money out of medical education. “The school might have turned a whole new shade of crimson when its flunking grade from AMSA was made public last summer,” Time wrote of Harvard’s now very public F on the Scorecard.

AdvaMed, the medical device industry’s trade association has introduced new guidelines for direct-to-consumer advertisements. The guidelines, which are voluntary, suggest that device ads should be consumer-friendly, and can feature celebrities, but while they may be friendly,  they won’t protect consumers, RxP’s Marcia Hams told Reuters.

Federal prosecutors will begin to single out and prosecute doctors who accept kickbacks for prescribing, according to this New York Times story. In the past, prosecutors have taken on the companies rather than the doctors, because they believed juries would not convict respected clinicians, a strategy that they say is about to change.

“What we need to do is make examples of a couple of doctors so that their colleagues see that this isn’t worth it,” Lewis Morris, chief counsel to the inspector general of the Department of Health and Human Services told the Times. “We want to send the message to the physician community — particularly surgeons — that you can’t do this.”

And in the wake of the Wyeth v Levine decision at the Supreme Court this week, Congressional leaders are preparing to introduce a law that would overrule the Court’s Riegel v. Medtronic decision, which established that consumers injured by a medical device could not seek recourse in state courts because federal law pre-empts it.

“Any impact of the Wyeth decision for device companies would depend on whether Congress does respond by overriding the device decision by the Supreme Court last year,” wrote the Times. “That ruling said the 1976 law giving the F.D.A. authority over medical devices had also provided a legal shield to devices that undergo the agency’s highest level of review.”

In the heartland, a bill that would limit gifts to doctors, require physician payments to be disclosed and creates an academic detailing program has passed the full Health Committee in the Iowa legislature.

Read more about the original bill in the Des Moines Register.

This in-depth story in the Milwaukee Journal-Sentinel looks at the new conflict-of-interest rules drafted by a task force at the University of Wisconsin. If approved, the rules would prohibit physicians from doing ‘dinner talks’ for drug companies and require faculty to disclose specific amounts of payments from drug and device companies, to within $1000. The current policies received a strong B grade on the AMSA Scorecard in 2008.

“When the spotlight of impropriety is shone on an institution, they either create a set of policies or they establish an office,” COI expert Eric Campbell told the Journal-Sentinel, noting that enforcement of any final policies is just as critical as the policies themselves.

A goof by the IRS has revealed some previously undisclosed donations to a charity Sen. Orrin Hatch started and for which he is still a booster. Payments by five pharmaceutical companies and PhRMA to the Utah Families Foundation far exceed what the companies could donate to Sen. Hatch’s re-election campaign.

“The donations, $172,500 in all, came at the same time that the Pharmaceutical Research and Manufacturers of America (PhRMA) was paying one of Mr. Hatch’s sons, Scott, to be its lobbyist in Congress,” wrote the Washington Times, which obtained the documents.

And just when we thought everyone had stopped asking, the Associated Press went and did it again: Is the FDA a broken agency?

“Bet yourself a new hat or a fine dinner that you are going to have a scandal a month,” Rep. John Dingell, (D-MI) told the paper. “They are running around like a lot of headless chickens.”

The much-anticipated decision in the case Wyeth v. Levine was announced today, in which the Court rejected, 6-3, the drug industry’s argument that FDA’s approval of a drug’s label should be a shield from liability under state tort law.

We’re as excited as those Legal Eagles over at Prescription Access Litigation, who blogged on the decision here.