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26 posts from March 2009

March 31, 2009

JAMA: Calls for Ban on Industry Contributions to Medical Societies

“Professional Medical Associations (PMAs) should work toward a complete ban on pharmaceutical and medical device industry funding ($0), except for income from journal advertising and exhibit hall fees.”

This is the bottom line of The Journal of the American Medical Association’s (JAMA) Special Communication entitled: Professional Medical Associations and Their Relationships with Industry a Proposal for Controlling Conflicts of Interest.

The Special Communication is authored by ardent anti-industry critics, David Rothman, Ph.D., the Director of the Institute of Medicine as a Profession (IMAP) at Columbia, Katherine DeAngelis, M.D., Editor of JAMA, one current and several former medical society officers including Steve Nissen, M.D., former President of the American College of Cardiology, and James Scully Jr., M.D., CEO of the American Psychiatric Association.

The “Special Communication” covers several major operations that they believe the medical societies should discontinue seeking funding for including: general budget support, national conferences, regional meetings, research, fellowship and training programs, practice guideline distribution, outcome measures, certain publications, and product endorsements.  In addition, they call for the elimination of all ties to industry, including funded research by presidents and officers of medical societies.

The paper funded by the Pew Charitable Trust but not disclosed through the Prescription Project to IMAP, follows the pattern of a similar paper entitled Health Industry Practices that Create a Conflict of Interest: a Policy Proposal for Academic Medical Centers that was orchestrated by the same groups (but not disclosed) and published in JAMA in 2006 that has lead to the Association of American Medical Colleges and major universities to revise their conflicts of interest guidelines.

The goal of this paper is stated plainly in the conclusion:

·         PMAs should work toward a goal of $0 contributions from industry;

·         PMAs leaders and executive staff should be free of conflict of interest; and

·         In time, the entirety of the board and members of the practice guidelines committees should be free from conflict ($0 dollars).

Conferences

Industry Sponsorship of Conference Programs

Establish Continuing Medical Education (CME) Committees that are free of conflicts of interest who could freely distribute the (I thought they wanted this banned) unrestricted educational grants from industry.  And, PMAs should seek funding from foundations and/or the National Institutes of Health (NIH) for specific courses or endowed chairs.

Funding, if sought, should go through a PMAs central repository or committee.

Conflicts of Interest Standards for Program Committee Members

At a minimum, members of the program committee should disclose any financial ties with industry to the committee chairman and legal counsel.

Gifting of Promotional Items

            A ban on all gifts and food.

Satellite Symposium

PMAs should not endorse, facilitate, or accept funding for satellite symposia.

Research by PMAs and “Members”

Industry should not be allowed to provide a grant for a project of its choosing or be associated with a specific project.

The research awards should be peer reviewed without any involvement from industry.

Funds should go to a central repository or committee.

Fellowships and Training Programs

Fellowships should not be named after the pharmaceutical company or device manufacturer.

Fellows should not know which company funds underwrote their fellowships.

Small societies should consider avoiding all such support.

Committees that Formulate Practice Guidelines and Outcome Measures

The establishment of guidelines and registries must be independent of all industry influence, actual or perceived.

Disclosure of industry relationships by committee members is not sufficient protection.

PMAs must excluded from guidelines committee persons with any conflicts of interest ($0 threshold) involving research support or additional income from a company whose products could be effected by the guidelines.

Publications (Journals)

Creation and distribution of guidelines and other advisory materials should be independent of industry funding.

Should not accept industry funding of journal supplements.

Companies are free to purchase the materials (journal articles), and distribute and refer to them in their promotional materials but without a logo or branding.

Advertising can be acceptable when it is clearly identified as such.

Companies should be permitted to purchase reprints of articles published in journals.

Product Endorsements

Never solicit or accept any offer that would attach its name or logo to a commercial product, service, or activity.

Affiliated Foundations

Affiliated foundations must be held to the same standards on conflicts of interest as the parent PMA.

Presidents, Officers, and Board Members

At a minimum the president, president-elect, immediate past president, vice president, secretary, and treasurer of a PMA should be conflict free ($0 threshold) during their tenure.  This includes no personal income, and no research support should be derived from industry. 

Guidance for PMA Members

As PMAs strengthen their conflicts of interest policies, they should use the policies to influence and lead their members to adopt similar standards.  The PMA should make it explicit that the principles underlying the organization’s behavior apply to the physician behavior.

Physicians should avoid marketing industry products.

Summary

They present no evidence of a problem, and they offer no viable solutions to solve the problem for which they show no evidence. 

The papers views only represent a very small but vocal minority of medical society members.

This is an opt-ed editorial with no balance or opposite opinion disguised as a “special communication.”

In reading the “Special Communication,” there is no mention of peer review.  Also, Katherine DeAngelis states she has no influence in its publication, sure…

This is the typical rhetoric of anti-industry purists who seek to scare the public into believing that all medical professionals who collaborate with industry are somehow tainted and that there is no good reason to collaborate with industry even in research. 

Nowhere does it focus on the best interest of patients.  It just assumes that conflicts of interest are bad, but does not speak to the value of collaboration.  While the United States government is developing a system to solve the nation's financial crisis through government/industry collaborations, this group seeks to end pharma and device industry collaboration with medical researchers and clinicians.  How can that be good for patients, and increasing access to medical care?

Certainly, it is a good idea for any organization or group of organizations to engage in self-reflection and self-regulation.  Indeed, the pharma and device industries have self-regulatory codes, and almost all associations have internal and external guidelines for dealing with conflicts of interest.  Most have revised their conflicts of interest policies in the last four years, and this “Special Communication” gives no credit to the changes.

Though the paper praises disclosure regimes, it says they do not go far enough.  What is their basis for that?  I believe we praise openness, transparency, disclosure efforts, and support programs that expand their reach and effectiveness.

The exclusion of journal advertising and supplements is self-serving to say the least, if this group is serious about a complete separation, they may want to start at home (Journals), as opposed to inflicting their self-righteous moral stance on everyone else.

This also explains the stance that the American Psychiatric Association took last week on sponsored food and education for their meeting, they were fully aware of this week’s publication.

They go out of their way to relate PMAs to university medical centers and push for even further restrictions (i.e., ban on industry funded research).  The major difference is that PMAs are not universities and the barrier to create a new medical association is quite small (this is America), and disgruntled members can easily form a less intrusive organization.     Um… The American Society of Clinical Psychiatrists….

One note sent to me by Bruce Ballande former Executive Director of the Alliance for Continuing Medical Education made a good point that the special communication recommends that “The American Association of Medical Colleges have recently adopted conflict of interest policies for faculty that can serve as useful models”. 

This is an interesting suggestion which contradicts the recommendations of the AAMC paper.  

Essentially the AAMC strongly recommends that faculty, students, residents and fellows participate in and attend only ACCME Certified education and not promotional education. 

Moreover the AAMC strongly endorses the continuation of commercial support for education and research unlike the recommendations of the article. 

March 29, 2009

Health Care Reform: Health Reform Dialogue – Agreement on the Basics

The Health Reform Dialogue (HRD) a prominent group of organizations on Friday released a laundry list of recommendations for health care reform.

The HRD is hopeful to enact meaningful health care reform, and includes a diverse group of members from Families USA, and Blue Cross - Blue Shield  Association to the National Federation of Independent Business (NFIB), American Medical Association (AMA) and Pharmaceutical Research and Manufactures Association (PhRMA).

They are proposing reforms in the broadest sense and have left the subject of universal coverage alone for the time being.

Some of their recommendations include:

·         Improve Medicaid and Children’s Health Insurance Program (CHIP) outreach and enrollment.

·         Establish a nationwide floor for Medicaid eligibility for all adults no lower than 100 percent of the federal poverty level.

·         Provide federal funding to the states for expanding Medicaid.

·         Set standards for additional federal Medicaid funding during economic downturns.

·         Restore legal immigrants’ eligibility for Medicaid coverage to mirror CHIP.

·         Give individuals eligible for Medicaid and CHIP the option to utilize those dollars to purchase employer-sponsored insurance, so long as full Medicaid or CHIP wrap-around coverage is available.

·         Provide advanceable, refundable tax credits or other subsidies on a sliding scale for individuals and families to purchase adequate and affordable coverage, which includes effective preventive services.

·         Provide additional assistance for out-of-pocket costs for low-income people and families.

·         Provide subsidies for small businesses to provide health insurance for their employees.

·         Provide a fair and transparent marketplace for purchasing insurance regardless of health status, age, or other factors.

·         Enact reforms necessary so that all individuals will purchase or obtain quality, affordable health insurance.

·         Ensure adequate payment to clinicians and providers by public programs to assure access to care.

Broad recommendations around prevention are those that no one would disagree with and include:

·         Identify effective clinical preventive services.

·         Facilitate patient utilization of effective clinical preventive services.

·         Promote coverage of effective clinical preventive services.

·         Encourage clinicians and providers to deliver effective clinical preventive services and follow-up treatment, as indicated.

·         Ensure a sufficient primary care workforce through an ongoing, dynamic, national planning and development process.

·         Continue to invest in health information technology (HIT) that supports wellness and prevention, both on the individual and community levels.

·         Identify existing health promotion “promising practices” and barriers to implementation.

·         Identify where there are gaps in knowledge about the most effective health promotion practices, and invest in research to fill those gaps.

·         Collect and disseminate information on wellness and health promotion.

·         Further encourage businesses to support healthy behaviors.

·         Encourage communities to be healthy.

·         Eliminate disparities in health.

·         Help individuals improve their health.

To improve quality in heath care they looked at a broad range of issues including government funds for health care IT.

·         Develop infrastructure to close gaps in quality and outcomes.

·         Conduct comparative clinical effectiveness research (CER) studies via a public-private partnership to provide additional information that can help improve care decisions.

·         Expand and accelerate the development of meaningful quality measures.

·         Expand reliable data sources to build an evidence base for quality care.

·         Fund state demonstrations of alternative medical liability reform models.

·         Develop standards to guide clinician and provider performance reports to ensure the accuracy, reliability, and utility of such reports and the measures used to develop them.

·         Build on current efforts to provide federal support, including clinician and provider incentives, for implementation of a strong HIT infrastructure that has the capabilities needed to improve patient care.

·         Consider the potential effect of new payment methodologies on medical innovation.

·         Develop clinician and provider incentives, aligned to evidence-based practices, based on measures and standards created and endorsed by professional membership societies and other bodies and through a multi-stakeholder process.

·         Research, develop, and implement Medicare payment reforms to improve prevention and facilitate coordination of care.

·         Improve billing efficiencies to reduce confusion and duplication for patients, clinicians, and providers.

·         Reduce administrative costs.

·         Align incentives to promote patient-centered care including innovative delivery models, including but not limited to, the patient-centered medical home model.

·         Address barriers to investing in quality improvement.

·         Work to reduce geographic, racial, ethnic, and gender disparities in health care delivery.

·         Ensure an adequate health care delivery workforce, including funding for training and loan forgiveness programs and payment reforms directed at primary care, public health and nursing, and other high-priority areas facing imminent shortages.

These are serious recommendations and though many like are being adapted without government intervention.

One large barrier to healthcare for small employers like our company is the cost of the insurance, though we have offered health insurance to our employees since our inception, the costs are astronomical.     

 So proposals that provide subsidies for small businesses to provide health insurance for their employees even if it was in the form of tax breaks would be very helpful and help finance additional jobs in our economy.

This is a really big deal that these groups representing employers, providers, payers, and manufactures who have been opposed to each other on so many issues can agree on such a long list. 

The inclusion of NFIB, America’s Health Plans, PhRMA and AMA which were four of the  largest contributors to stopping the Clinton era health care reform effort, signals that there significant progress in both the thinking of these organizations and the policy makers.

There has to be some measure of sanity if we are going to reform the health care system.  These proposed reforms go a long way to getting us there

 

March 25, 2009

American Psychiatric Association Bans Meals for Doctors – Next Year its Denny’s

Tahmina Najemyar Picture

It is official, you can no longer get a free meal at the American Psychiatric Association (APA) annual meeting. 

Under intense scrutiny from the media, the APA’s Board of Trustees voted this month to phase-out industry-supported symposia along with industry-supplied meals at its annual meetings.

According to the APA, with this move, the APA remains at the leading edge of a trend throughout medicine to increase transparency and reduce potential financial conflicts of interest.  Symposia at major medical meetings that supply doctors with continuing medical education (CME) credits are sometimes funded by pharmaceutical companies, a practice that has invited a concern that the sessions may be biased in favor of the sponsoring company’s medications.

 “Although we took great care to avoid biased reporting at all our symposia, we came to the conclusion that the only way to totally eliminate the risk is to have the symposia supported by the APA alone,” said Nada L. Stotland, M.D., M.P.H., President of the APA.

The decision includes the elimination of industry-supplied meals that were provided during the industry-supported symposia.  “There is a perception that accepting meals provided by pharmaceutical companies may have a subtle influence on doctors’ prescribing habits,” said James H. Scully Jr., M.D., the APA’s Medical Director and CEO.

 “While industry-funded meals used to be normal operating procedure at medical meetings, a sea of change is currently underway in how we manage industry relationships,” he said.  “What was acceptable five years ago isn’t necessarily acceptable today.  Change is necessary, and the APA wants to stay at the forefront of a new and better way of doing things.”

It is unfortunate that medical societies have gone the way of self-flagellation.  As they noted, the APA took great care to avoid biased reporting. 

It is not like the media is going to say, hey great job except for 15 seconds, they should expect that the next move will be to eliminate their exhibit hall, any banners-posters advertising a product, and why stop there, they will next ban poster sessions conducted by industry experts, advertisements in journals.  This is a never ending cycle to stop all relationships with industry.

I wonder if this will stop companies from paying for meals for their international attendees or meetings held without the cooperation of the APA, doctors want to learn and sometimes learning over dinner is a great use of time. 

I guess from now on APA participants will have to wait in line for breakfast at the local Denny’s.

APA Press Release

Wall Street Journal Blog: Psychiatrist Stop Taking Money from Drug Makers

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