Industry should stop funding physician education. That message was delivered – again and again yesterday – to the Senate Special Committee on Aging.

Under the chairmanship of Senator Herb Kohl (D-WI), lead co-sponsor of the Physician Payments Sunshine Act, the Committee held its fourth in a series of hearings on financial relationships between doctors and drug/medical device companies.

“Eliminating industry sponsorship is appealing for its purity and simplicity,” said Lewis Morris, chief counsel to the Inspector General of Health and Human Services, enumerating the many problems with industry-funded continuing medical education (CME). However, that won’t happen overnight. In the interim, OIG recommends a number of steps companies should take. One such idea was to establish “pools” of funds overseen by independent boards of experts, although Mr. Morris also noted that this approach had been tried by the American Academy of Orthopedic Surgeons, but not a single company would support it.

Eric Campbell, of Massachusetts General Hospital and a member of the Institute of Medicine Committee on Conflict of Interest, noted that IOM had spent a year looking at all the available data and concluded that CME has become far too dependent on industry funding.  “Given the lack of validated and efficient tools for preventing or detecting bias in educational presentations and programs,” Dr. Campbell said that industry funding “creates a substantial risk of bias as education providers seeks to maintain or attract industry support for future programs.”

There were also those advocating continued dependence on industry funding.

Harvard’s Thomas Stossel once again made his argument that new prescription drugs have improved medical care over the past 40 years; therefore, it is beneficial when physicians rely on education paid for by the sellers of those products. It was a logical fallacy that Senator Al Franken (D-MN, and the newest co-sponsor of the Sunshine Act) was quick to point out in the liveliest exchange of the day.

And Murray Kopelow, head of the Accreditation Council for Continuing Medical Education, said that after mulling a stop to accredited industry-supported programs in 2008, the council “would not be taking any action to end the commercial support of accredited [CME],”  and defended its continued efforts to clarify independence criteria and firewalls.

But Steven Nissen, a Cleveland Clinic cardiologist and vocal supporter of greater transparency and better drug safety, called the accrediting body “uninterested or incapable” of enforcing its own rules, and called for its end.

“Whatever ACCME is doing is ineffective,” said Dr. Nissen. “We need ACCME to go away and we need to replace it with something else.”  He said that third-party companies called medical education communication companies  are very much behind the wheel of CME programs that claim support from “unrestricted educational grants,” and that based on the selected topics and speakers, he can nearly always guess the sponsoring company.

The American Medical Student Association’s Jack Rusley also testified, as did James Scully, head of the American Psychiatric Association, which voted earlier this year to eliminate all industry-funded symposia at its annual meeting.  Dr. Scully told the committee that foregoing that funding would cost his association about $1.5 million this year, but that it would be worth it in terms of greater public trust.

There’s more coverage at the BNA Health Care Daily Report, Medical Marketing & Media, and the Carlat Psychiatry Blog, which live-blogged the hearing.

The Association of Clinical Researchers and Educators, a group convened to defend unregulated industry-physician relationships and fight a growing movement to limit the influence of marketing on medicine, held its charter meeting on the campus of Brigham and Women’s Hospital in Boston yesterday.

While some of the conference was an opportunity for academic physicians like ACRE director Thomas Stossel MD to rail against “a belief system” that has made key opinion leaders, speakers bureaus, and ghostwriting into “meaningless demonic slogans,” much of the daylong agenda was devoted to promoting stuff we believe, too: namely, the importance of academic-industry collaboration in the development and approval of new drugs. Case studies in the accelerated research into multiple myeloma and pediatric cancers illustrated the good that can come from industry and academic physicians working together on legitimate, necessary research — research that won’t be hampered by current state gift and disclosure laws, or by federal transparency proposals like the Physician Payments Sunshine Act (S.301).

Though conference presenters expressed everything from concern to outright mockery at Massachusetts’ gifts and disclosure law, attorneys there to discuss what the law means for physicians reminded the audience that much of the Massachusetts gift ban was just the codification of the industry’s own voluntary codes, and thus shouldn’t represent a sea change in conduct. Regulators’ and lawmakers’ care to protect innovation, research, and clinical trial conduct in the state went unmentioned.

Several speakers chastised the industry for being silent on its own behalf (though in reality, both AdvaMed and PhRMA have come out in support of a federal transparency law). Accusing the media of blood thirst and bias was another common refrain.

“Attacking [academic medical centers] is like attacking girl scouts,” said Thomas Fogarty MD, director of the Fogarty Institute, who spoke about the importance of collaboration in drug innovation.

“Nobody is holding the press accountable for the harm they have done,” said J. Michael Gonzalez-Campoy MD, an endocrinologist from Minnesota and a board member of the American Association of Clinical Endocrinologists, the one medical professional society that threw its support behind ACRE. “My patients are being harmed by biased reporting,” he said.

Many speakers criticized their own profession’s efforts to become more transparent about conflicts of interest, including recent recommendations from the Institute of Medicine and the Association of American Medical Colleges (AAMC) that call for greater disclosure and limits to industry gifting and involvement in medical education.

Some also decried conflict-of-interest policies that individual AMCs have developed.

“The really sleazy stuff in medicine has come out of academic institutions,” said Avi Markowitz MD of the University of Texas-Medical Branch at Galveston, whose own policies limiting drug company marketing on campus received an “A” on the American Medical Student Association’s PharmFree Scorecard. Policies like these “are being handed down from deans and administrators in academic medicine who have no financial needs, and don’t live in the real world,” Markowitz said.

Toward the end of the meeting, the presenters seemed to engage in an informal horse-race about their financial disclosure listed in the program.  Michael Weber, a professor from SUNY Downstate Medical Center College of Medicine, began his talk this way: “My disclosures are in the booklet, and I’m proud to say my list is longer than anyone else’s.” But when Fogarty got up to the podium, he said he thought he probably had Weber’s list beat.

“I am so conflicted I’ve become un-conflicted,” he said.

The National Institutes of Health (NIH) is receiving a lot of advice on how to tighten its conflict-of-interest standards, and much of it favors increasing transparency and expanding disclosure.  Sixty-two organizations responded this week to a call for public comments about how investigators and institutions should disclose financial interests related to publicly-funded research.
Among the specific questions NIH asked:

• Would expanded disclosure by investigators allow institutions to better identify conflicts?
• Should exemptions, including a $10,000 annual payment disclosure floor, be altered?
• Should institutions report additional information to NIH along with identified Financial Conflicts of Interest (FCOIs)?
• Should certain financial interests always be considered a conflict / be prohibited for certain types of research?
• Should there independent confirmation of institutional compliance be required?

In our joint comments, the Pew Prescription Project and Community Catalyst recommended that:

• Investigators should disclose all financial relationships to their university or affiliated institution, regardless of value;
• NIH should lower its current threshold for institutions to report conflicts (currently set at $10,000 or 5 percent equity);
• Reports of Financial Conflicts of Interest (FCOI) to NIH should include more information, specifically the criteria and categories identified in the Physician Payments Sunshine Act,  S.301;
• The proposed increased disclosure will enable NIH to better enforce its regulations around objectivity in research; and
• S. 301 will be an important tool for NIH and institutions to audit disclosures, underscoring the need to align the information reported to NIH with the proposed Sunshine criteria.

The Pew/Community Catalyst recommendations – one of the few submissions from consumer or public-interest groups – were broadly similar to those from the influential Association of American Medical Colleges and the Association of American Universities. AAMC/AAU recommended:

• The definition of a Significant Financial Interest, and therefore what is reported, be changed from its current level – payments above $10,000 – to $5000, which would mean universities would have to report all such payments to the NIH. They also recommended lowering the reporting floor on equity from 5 percent to .1 percent.

• Institutions provide more details about the management plans they develop for researcher conflicts of interest,

• That there be no automatic dollar-amount “trigger” from participating in research, leaving those decisions to individual institutions

Many of the 37 universities that commented – including the University of California system, University of Texas, Harvard and Stanford – closely hewed to these proposals.

U.S. Senators Charles Grassley (R-IA) and Herb Kohl (D-WI), both dogged investigators of academic-industry conflicts in the last two years, and co-sponsors of S.301, suggested that:

• researchers be required to report all of their outside income to the nearest $1000;

• a required university management plan be developed for all potential conflicts of interest

• both disclosures and management plans be publicly available on the NIH website.

And the Federation of American Societies for Experimental Biology, the largest U.S. biomedical research group which represents 22 scientific associations and 90,000 scientists, recommended that the definition of Significant Financial Interest be dropped from the current $10,000 to $200, allowing for a broader set of payments to be reported the NIH or institutions.

But not everyone supported greater disclosure. At least one group called for looser standards. The Biotechnology Industry Organization (BIO), a trade group, recommended that the reporting floor be raised, in order to align with the FDA’s regulations on payments that must be reported with a marketing application for a new drug: $25,000 in industry payments or $50,000 in equity interests. BIO also suggested the NIH monitor institutional conflicts of deans, department chairs, and institutional trustees, who are often charged with managing the conflicts of faculty researchers.

Other industry groups, though, favored more transparency. Bayer called for the exemptions to be struck from “significant financial interests,” recommending that researchers report payments of all sizes to their university or research institution, though Bayer said that any additional information about conflicts sent to the NIH would be burdensome. And Merck, citing S. 301 and the Institute of Medicine’s call for a national disclosure law, suggested that the new NIH rules match any federal transparency law that is enacted.

To see the full docket, go here.