Policy and Medicine

Institute of Medicine: Redesigning Continuing Education in the Health Professions

 

The Institute of Medicine (IOM) issued a report titled Redesigning Continuing Education in the Health Profession.  This is the outcome of the IOM Planning a Continuing Health Professional Education Institute which was funded by the Josiah Macy Foundation.

 

The report consisted of a 12 month study, 3 face-to-face meetings, 2 public workshops with 17 speakers, an “extensive literature review,” and 16 external reviewers.

 

Overall the report is ambitious, involving research and regulation for a diverse group of professions including physicians, nurses, pharmacists, physical therapist, social workers, dieticians, dentist and all other health professionals. 

 

It is a top down driven report calling for a central system for research and regulation of all continuing education in the health professions (CE).  It somewhat falls into a belief that a small group of 13 people should decide what is best for educators and clinicians, potentially missing the marketplace and innovation.

 

The report states that the purpose of CE is to enable health professionals to keep their knowledge and skills up to date, with the ultimate goal of improving performance and patient outcomes. Consequently, the report suggests that there are major flaws in the way CE is conducted, financed, regulated, and evaluated.

 

They report flaws that exist in the current CE system include:

 

· Meeting regulatory requirements rather than identifying personal knowledge gaps

· Concerns about conflicts of interest in CE activities

· Regulations that vary widely by profession, specialty, and state, leading to inconsistent learning

 

The report also claims that the science underpinning CE is fragmented and underdeveloped, which leads to “didactic learning methods (e.g., lectures) in traditional settings (e.g., auditoriums); little specific information about how to best support learning; and health professionals lacking a dependable basis for choosing among CE programs.

 

Such a claim is somewhat overstated as any heart surgeon, oncologist, or other specialist would contest to, as CE programs have helped keep these specialists up to date on the newest treatments and breakthroughs.

 

From these claims, the report calls for a new, comprehensive vision for CE that prepares all health professionals to perform to their highest potential, which they call Continuing Professional Development (CPD). In CPD, learning opportunities:

 

· Stretch from the classroom to the point of care

· Shift control of learning to individual practitioners

· Adapt to individuals’ learning needs

 

The CPD system offers promise to:

 

· Advance evidence-based, inter-professional, team-based learning

· Strengthen the research workforce, particularly through academic institutions

· Engender coordination and collaboration among the profession

· Provide higher quality for a given amount of resources

· Lead to improvements in patient health and safety

 

To achieve this CPD system, the report recommends that the Secretary of the Department of Health and Human Services should commission a planning committee to develop a public-private institute for continuing health professional development. The role of this institute would be to coordinate and guide efforts in content and knowledge of CPD; regulation across states and professions; financing of CPD; and strengthening of a scientific basis. What this boils down to is simple: government controlled continuing education. One obvious problem is: where are the resources (money and staff) to support such a drastic change?

 

Financing CE

 

The report rightly asserts that CE will need the necessary resources (money) because of the innovations in learning, specifically about treatments, drugs and devices created by academic-industry-government collaboration. The report notes that at present, 58% of CE funding comes from industry, and out-of-pocket cost to physicians is 42%, or $1,200 per physician per year.

 

In addition, IOM notes how medical schools provide the most hours of continuing medical education (45 percent of the total). Almost another quarter of all CME hours comes from professional societies and organizations, who are also important providers outside of medicine (ACCME, 2008). Other sources of CME hours include employers of health care professionals, such as the Department of Veterans Affairs (VA), and health care institutions, such as hospitals and insurers.

 

Other providers of CME, who are crucial for medicine and physician include medical education and communication companies (MECCs). These companies which are accredited by the ACCME, provide tremendous service to physicians and health care providers, even though the report believes their motivations to sometimes have the potential for bias.

 

This potential however is minimal, because as the report states, “CE funding comes from numerous sources, including health professionals themselves, employers, commercial entities, and the government.” Bias can easily be avoided by the fact that because many physicians have to pay for CE “they are likely to choose an activity based on its perceived value.” In other words, they know who is funding the program, and as highly trained professionals will be able to judge the content and clinical benefit accordingly.

 

Ideas for new ways to fund CE are obviously important but, as the report notes, “the federal government provides little direct financing for CE for health professionals.” Although some federal money is spent on CE for professionals in the VA or DOD, “no consistent investment for a large majority of non-government related health professionals exists.”

 

The lack of government funding, and thus the increased reliance on private industry funding, causes critics to believe conflicts may arise. Such claims are also contradictory considering the report itself states that “MECCs can be significant resources, for example, by supplying well-trained staff who provide high quality CE.” Moreover, the potential for bias has also been significantly reduced over the past five years by ACCME and PhRMA, who have ensured that commercial interests are kept separate from learning activities and course content. For example, the ACCME requires CME providers to give a balanced view of therapeutic options and encourages the use of generic names of therapies, rather than promoting specific proprietary names (ACCME, 2006).

 

With organizations already regulating CE payments, it is hard to see what is wrong with the current system. Today, CE does “directly align with the goals of driving improved quality of care and patient safety and it does support a mix of activities that are effective both in terms of performance and cost.” To safeguard CE from making a profit goes against the very nature of freedom of enterprise and numerous American principles. Investing in CE requires a significant risk and investment, and profits do not reflect the impact such programs have on saving lives and training physicians.

 

IOM notes that if all industry funding were removed, the average physician could fund his own CME and continue attending the same types of CME activities by investing about $3,500 annually. But the report states that this is an “estimate and does not take into account the nuances of the various sources of CME funding.” The report also states that ‘it is not even clear how the content would change in the event” that industry funding is removed.

 

Another reason why removing industry funding of CME is problematic is because physicians want to learn and be motivated in a network of their peers to be updated on new practices. In fact the report states that “a mix of cost-effective CE could be achievable in the current financing environment.”

 

In the absence of evidence, the committee assumes that physicians could maintain participation in activities similar to the ones in which they currently participate (e.g., a hybrid of low-cost, journal-based CME with occasional participation in higher quality, higher cost activities) without paying more out of pocket.

 

Since IOM clearly states that “no evidence exists to predict how physicians would respond to changes in CE financing, and a determination cannot be made of whether the costs of an ideal system would be greater than the costs of the current system,” why make any changes?

 

Summary

 

Overall there are lots of interesting recommendations dealing with continuing education in this report.  They have truly identified a problem in the system that the focus of CE is often on meeting regulatory requirements rather than identifying personal knowledge gaps.

 

There is a tread of national control throughout the report, and one of the presenters on the conference call stated that they realize the next committee to report on this (always more committees) will temper their recommendations.  Also requiring more regulations may not necessarily help the problem of over regulation.

 

The report which would like to set up some type of national system for all CE in the health professions is ambitious project but not a current national priority given the expenses that will go into healthcare reform.    To accomplish great things one must think big thoughts, this report is not lacking in any big thoughts. It will be interesting to see if any of those thoughts are implementable.

 

For details on the recommendations the report and slide set are available online.  The report provides details on the nature of the recommendations, the data and science the members of the committee hope to collect from this effort.

 

Institute of Medicine:  Redesigning Continuing Education in the Health Professions 12/04/09

 

Full Report

Slide Presentation

Summary

 

Macy Foundation-IOM: Planning a Continuing Health Care Professional Education Institute: Recommendations from the Institute of Medicine Webcast

The Macy Foundation funded Institute of Medicine (IOM) report on Planning a Continuing Health Care Professional Education Institute is expected to be released sometime mid to late November.

The Alliance for Continuing Medical Education (the Alliance) announced a webcast on this report for December 9^th. 

According to the Alliance: A report from the Institute of Medicine (IOM) on recommendations for the development of a national inter-professional institute devoted to the continuing education of healthcare professionals is due to be released shortly as a result from the recommendations from the 2008 Macy Foundation report on "Continuing Education in the Health Professions: Improving Healthcare through Lifelong Learning."

The purpose of establishing such an institute is to advance the science of CE by promoting the discovery and dissemination of more effective methods of educating health professionals over their professional lifetimes, by developing a research enterprise that encourages increased scientific study of CE, by developing mechanisms to assess research applications, by stimulating new approaches to both intra- and inter-professional CE, and by being independent and composed of individuals from the various health professions.

This is more than likely a report recommending a stimulus package for educators working on CE research.   Though this is a somewhat laudable goal the Macy Foundation has made no bones about their goals in hiring the IOM ($428,177) to legitimize their Bermuda Conference.  They were actively involved in the selection of panel members, fully funded the committee, and the opening meeting started with a presentation titled: Understanding the Committee’s Charge: A Discussion with the Sponsor - George Thibault, Josiah Macy Jr., Foundation.    Other opening day activities included presentations on concurrent Macy funded Activities to Inform the CE Committee:

Dave Davis, Association of American Medical Colleges (~$300,000 Macy Funding) Introduce workshop to (1) review formal CE, (2) review a range of alternative interventions, (3) summarize the inter-professional education literature, and (4) review current knowledge in lifelong learning.

Eric Campbell, Institute for Health Policy, Harvard Medical School (~$150,000 Macy Funding) Introduce plan to (1) review what types of CME work best, (2) understand the amount of CME physicians need, (3) review current CME organizational structures, and (4) explore and model alternative CME payment methods.

Copies of the Macy Foundation Report were given out to all members of the committee at the beginning of the meeting with the Chairman stating that this is an important document and will serve as our guide in writing the IOM report.

The goals of the Macy Foundation Report were simple:

    Eliminate Commercial Support of CME in Five Years

    Eliminate all private providers of continuing medical education

    Replacing the current accreditation system with a government controlled system

Because the report will be based on the Macy paper along with committee members including Katherine DeAngelis, Editor of JAMA who is against all involvement between industry and physicians, this report promises to be a rehash of old materials with the new cover of the IOM.

A background article of this report and other Macy Supported initiatives was published in May in the National Review titled: Conflicting Interests: The effort to push the private sector out of continuing medical education.

One interesting note that with the exception of the first meeting all subsequent meetings have been behind closed doors and not open to the public.

At one closed session in May, (which at the time of the meeting was listed on the IOM website as a closed meeting not open to the public), the IOM apparently held one open presentation that featured Mike Saxton the Senior Director of Medical Education at Pfizer sharing his “personal” views on CME funding.  

Catherine Cleary, MD of Pfizer had previously testified at the open meeting last December as the only representative of the pharmaceutical industry.

There is also a webcast later in December on Macy Foundation funded initiative with the Association of Academic Medical Centers (AAMC)  Recommendations from AAMC/AACN Lifelong Learning Consensus Conference

Overall this should be interesting, for more information on the webcast go to:

 

December 9, 2009

2:00 – 3:00 PM Easter Time

Planning a Continuing Health Care Professional Education Institute

Recommendations from the Institute of Medicine

This report describes recommendations for the development of a national inter-professional institute devoted to the continuing education of healthcare professionals.

Click here to register!

 

January 13, 2010

2:00 – 3:00 PM Eastern Time

Continuing Education in Nursing and Medicine: What Does the Future Look Like?

Recommendations from AAMC/AACN Lifelong Learning Consensus Conference

This report that will discuss recommendations for delivery and format of continuing education and the development of lifelong learning skills in health professionals the delivery.

Click here to register!

FDA Hires IOM to Review Medical Device Approval System

The Food and Drug Administration (FDA) recently issued a press release announcing the commissioning of the Institute of Medicine (IOM) to study the premarket clearance process for medical devices in the U.S.

According to the release, the IOM study will examine the premarket notification program, also called the 510(k) process, for medical devices, and the FDA’s Center for Devices and Radiological Health (CDRH) will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.

The goals of these evaluations according to Jeffrey Shuren, M.D., acting director of CDRH, is to help “determine how the 510(k) process can be improved to better support FDA’s mission to protect and promote the public health.”

The 510(k) process was established under the Medical Device Amendments of 1976 with two goals:

• Make safe and effective devices available to consumers
• Promote innovation in the medical device industry.

The release calls for review of the 510(k) process because “technology and the medical device industry have changed dramatically.” The IOM commission will specifically try to answer two principal questions:

• Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
• If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

The $1.3 million IOM review is slated for completion in 2011. Part of the review will include two public workshops during the next nine months, as well a final report that will be published in March 2011. Dr. Shuren also noted that in addition to this review he has outlined six priorities for CDRH including:

• Creating an internal task force on the use of science in regulatory decision-making
• Developing an effective compliance strategy
• Optimally integrating premarket and postmarket information
• Increasing transparency in decision-making
• Establishing clear procedures to resolve differences of opinion.

While it is certainly important for the FDA and CDRH to monitor such changes, it is equally important not to hinder such breakthroughs—often led by collaboration with industry and academia—through burdensome evaluations that scare away scientists and researchers. The criteria IOM should focus on is ensuring that the technological breakthroughs from the medical device and drug industries are kept intact, so that we can keep treating patients and saving lives.   Simply setting up further delays in approvals does not constitute a solution.

For more information about the FDA premarket approval of devices read the GAO report on FDA system for device approval.

IOM: Report on Conflict of Interest: Maybe Best of Intentions but Overreliance on Distant Past

 

 

Despite all the best intentions, the federal Institute of Medicine is trying to make proposals for CME’s future based on facts from the distant past. In its 2009 report on Conflict of Interest in Medical Research, Education, and Practice, the IOM released a report (underwritten by the Josiah Macy, Jr. Foundation) calling for an end to educational grants from pharmaceutical and medical device manufacturers.

 

Some of the report’s conclusions (Eliminate non-educational interventions from university campuses) make sense. But when you dig into the report’s findings on CME, you find mostly stale data and arguments that do not take into account the dramatic regulatory and accreditation board rules now required to ensure that CME excludes industry influence and addresses all conflicts of interest.

 

Most important, the report generally confuses Certified CME with other forms of so-called “education” and relationships that have nothing to do with CME. To be clear, Certified CME programs only are those developed by accredited providers of CME in compliance with all ACCME standards and rules, as well as FDA and Health and Human Services Office of Inspector General Compliance Guidance requirements that ensure CME is “independent from promotional influence.”

 

But by trying to address conflicts in research, education, and practice, the IOM mistakenly blends Certified CME with non-CME interactions. The result? Confusion and outdated data regarding CME, not clarity.

 

Some examples:

•  In the report’s table 5-1, the IOM mentions that drug companies provide lunches, pens, snacks, and dinners for medical students in the third year of schooling. The report complains of “non-educational” interventions in the learning environment. Worthy complaint, but the comments deal with grad school and do not apply in the least to Certified CME activities that occur after physicians are practicing.

• The IOM report cites studies about “influence” by manufacturers that date back to 1986. Oddly enough, the report does not mention at all the academic literature survey on bias produced by the ACCME in 2008 concluding that “no empirical evidence” exists to support a connection between industry grant funding for Certified CME and bias.

• In a flagrant violation of the principle of “evidence-based” reporting, the IOM report includes a “personal account” in which an unknown person states that CME speakers were hired on the basis of their support for a “sponsor’s message.”  If this were the case, it would be a clear violation of ACCME rules and would cause the accredited provided to either be placed on probation or lose its accreditation immediately. The report fails to mention that accredited providers must collect audience evaluations regarding any possible bias and have policies to address any such issues. In addition, the ACCME has a process for handling complaints and has implemented a monitoring system to detect and address any bias. Last, nobody seems to realize that physicians are not compelled to attend any CME program (they can get a year’s worth of required credits over a few days at a single society annual meeting). Physicians attend CME because it’s useful and needed, given the current explosion of healthcare information. Physician CME attendees also are required to evaluate programs for bias, and this information is easily obtained.

• The IOM report claims that bad CME programs were developed related to the federal Neurontin and Vioxx cases. The problem? The problems cited by the IOM report are specifically addressed and prohibited by current rules (the CME enterprise has addressed past problems).

• The IOM report slams the ACCME by citing 2001 and 2003 articles stating that the ACCME Standards for Commercial Support of CME activities do not deter industry influence. Two problems: 1) the original articles did not include evidence to support the claim, and 2) the ACCME updated the Standards in 2004, as well as several new definitions, policies and rules approved in subsequent years, ensure that Certified CME is independent from promotional influence.

The CME enterprise has undergone many positive changes during the past five years. It’s time organizations, such as the IOM, understands and acknowledges them.

This commentary was written by Stephen Lewis the President of the North American Association of Medical Education and Communications Companies.  Early in his carrier Steve served as press secetary for US Senator Thimothy Worth (D-CO).

IOM: Comparative Effectivenes Recommendations – Top Down Bureaucracy at Its Best

 

In the midst of all the chaos surrounding the economic downfall, Americans overlooked a key component of the American Recovery and Reinvestment Act (ARRA): the Comparative Effectiveness Research Council.

 

The purpose of the Council is to determine what drugs are more/less effective than similar drugs.

 

One of the provisions of ARRA was for the Institute of Medicine to recommend a list of priority topics to be the initial focus of a new national investment in comparative effectiveness research. As a result, the Institutes of Medicine recently published a report titled: Initial National Priorities for Comparative Effectiveness Research.

The report was supported by funds from the Agency on Healthcare Research and Quality, the National Acad­emies President’s Fund, and the Robert Wood Johnson Foundation.

 

The IOM committee identified three report objectives: 1) establish a working definition of CER, 2) develop a priority list of research topics to be undertaken with ARRA funding using broad stakeholder input, and 3) identify the necessary requirements to support a robust and sustainable CER enterprise.

 

The report also outlines 100 Initial Priority Topics for Comparative Effectiveness Research. Within the list the topics are listed by quartile (groups of 25), with the first quartile having the highest priority.

The 100 topics were selected from some 2,600 suggestions, with 17 suggestions coming from device companies and 11 from pharmaceutical/biotechnology firms. Some of the comparative effectiveness research projects in the first quartile are:

-          hearing loss in children and adults; upper endoscopy utilization; care coordination programs, such as the medical home; Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriatic arthritis; health care associated infections (HAI); prostate cancer.

 

Some of the more disturbing suggestions from IOM include prioritizing lower back pain; yoga; homeless care; and even acne ahead of or at the same level as pediatric cancer.

 

Is this really what the government is going to use or is this just a suggestion to them from the IOM?

 

Does the government really assume that the higher priority is to save money and produce better outcomes researching low back pain versus pediatric cancer?  

In addition, the new report, offers recommendations for the $400 million given to the Department of Health and Human Services from ARRA, according to the Wall Street Journal. Conversely, the Institute of Medicine stated it did not consider cost in its assessment of priorities.

Dr. Harold Sox, editor of the Annals of Internal Medicine and co-chairman of the committee that picked the priorities noted that committee did no include cost because it was "a very big topic, and one that we knew we didn't have sufficient time to deal with.  Others noted that "the focus of comparative effectiveness research is that it leads to better care, not cheaper care."

Accordingly, research on these and future topics will not yield real improvements unless the results are adopted by health care providers and organizations and integrated into clinical practice. Dr. Cox further said that:

“Conducting high-quality research and implementing the results pose major challenges, and thus "it is going to take awhile" before the impact of the research is seen in hospitals and doctors' offices.

Ultimately, comparative effectiveness research is an “ongoing process to accommodate new treatments and changes in practice. As a result some people believe that as comparative research develops, this council will make decisions based on cost, especially since IOM did not consider cost.

How can Congress and IOM consider whether medicine is going to be more effective when the results from this research will make care unaffordable to Americans, and degrade the health care system further?

Top down recommendations always favor the elite vs. the needy.   Would it not be better to randomly survey a select group of healthcare providers and patients to come up with what is needed as opposed to Washington bureaucrats deciding what is best for patients.

IOM and Congress need to realize one crucial factor when determining their priorities for comparative effectiveness research: although recommendations can and should be made, flexibility is essential for the individual physician to prescribe what he or she feels best for the individual patient.

Interactive CER Priority List

Witness Testimony from Stakeholder Meeting

Press Release

 

Institute of Medicine: Macy and IOM Conflicting Interests

In today’s National Review Online is a feature article “Conflicting Interests” outlining the close agenda that the Macy Foundation has with the Institute of Medicine, AAMC and others on their conflict of interest reports and other upcoming reports to rid medical education of ties with the private sector.

The Macy Foundation is funneling millions of dollars in “donations” to legitimize their CME report.

The Institute of Medicine and the Macy Foundation are part of a coterie of bureaucrats and journal editors who hold the anachronistic view that the healing arts are above the simple business of the world.

For those who think all this “bad news” is a coincidence, it is worth while reading.

National Review:  Conflicting Interests

IOM Report on Conflict of Interest: Coalition for Healthcare Communication Responds

The recent Institute of Medicine: Conflict of Interest in Medical, Research, Education and Practice report has brought about swirls of discussions.

The report is basically a 350 pages exhaustive review article on the virtues of eliminating all potential for commercial bias.

 A few examples include eliminating:

·         Non-Accredited talks by physicians

·         Gifts of any kind

·         Visits by Drug Reps to Physicians Offices

·         Drug Samples

Adding:

·         Nationalized disclosure of all payments to all healthcare providers

·         Nationalized Pooling of CME Commercial Support

According to the IOM the report cost $1,375,000.

The Coalition for Healthcare Communication an organization that defends the right of health professionals and consumers to receive truthful information regarding pharmaceuticals and medical products, as safeguarded by the Constitution of the United States. 

The Coalition released a brief analysis of the report and its effect.  As a matter of personal disclosure, I am part of the Coalition and participated in preparing the analysis.

While the tone of the IOM press material and draft report suggests a rather modest call for change in the relationships among the industry, organized medicine and prescribers, the press statements of the participants and a careful reading of the report (over 350 pages) illuminate an intent by the Committee to aggressively limit the role of the industry in organized medicine and policy making.

"The IOM recommendations seem both naïve and foolish," according to John Kamp, Executive Director of the Coalition for Healthcare Communication. "On the same day that the world's health leaders were working with research-based drug companies to address the possible swine flu pandemic, IOM proposed new limits on full participation in public health decision making and implementation. Instead of expanding prohibitions, enlightened leaders should embrace industry collaboration to advance the tangible and immediate health needs of the nation's citizens and move forward on long-needed health care reform."

For the analysis:  Coalition Responds to IOM Report on Conflict of Interest

IOM Conflict of Interest: The Buzz Around Town

This week there have articles, commentaries and statements flying around due to the release of the Institute of Medicine Report on Conflict of Interest, in Medical Research, Education and Practice.

Some of the Key quotations include:

PhRMA:  Statement on Institute of Medicine Report

Throughout the report the IOM writers elude to a misnomer that the major expense at pharmaceutical companies are devoted to marketing than research, as a basis for their recommendations.   This statement may be true of the IT industry but nor reflective of pharmaceutical companies.

PhRMA’s statement clarifies that “America’s pharmaceutical research companies spend far more on research and development (R&D) than on marketing. In 2007, pharmaceutical companies invested $63.2 billion on R&D of new medicines, while spending around $11.5 billion on promotional activity directed to physicians, journal advertising and consumer advertising, according to IMS Health. Last year, pharmaceutical companies spent a record $65.2 billion on R&D.

“According to the Congressional Budget Office (CBO), America’s pharmaceutical research companies are ‘one of the most research-intensive industries in the United States.’ Pharmaceutical firms invest as much as five times more in research and development, relative to their sales, than the average U.S. manufacturing firm, CBO states. 

Recommendations by IOM and others can also help advance ethical, professional relationships.  But it is important to balance the need to manage potential conflicts of interest against the possibility that overly restrictive policies – for example, prohibitions on physicians’ use of drug samples or on the availability of industry funding for CME – could have negative consequences for patient care.”

Senator Grassley:  Institute of Medicine Report on Conflict of Interest

“It’s a shot in the arm to the reform movement to have the prestige and policy heft of the

Institute of Medicine on the side of transparency.  The more disclosure, the better, for holding the system accountable and building public confidence in medical research and practice.”

New England Journal of Medicine: Controlling Conflicts of Interest

This is an extremely pro-regulatory article and the Author Robert Steinbrook, who presented before the IOM committee, does a good job summarizing the report at the end, you can tell that he is hopeful that many of the recommendations though conflicted (the committee kept going back and forth in the document) will be adopted.

Although specific recommendations may be criticized as either too strong or too weak, the IOM's overall proposals are comprehensive and — if adopted — would most likely have substantial effects on individual physicians and medical institutions. However, there has been no shortage of previous reports and calls for change; the new report lists 16 of the "more prominent reports" that were released between 2001 and 2008 alone. So the institute's proposals could merely provide more fodder for discussion — or perhaps mark a turning point in controlling conflicts of interest in medicine.

New York Times: Institute of Medicine Calls for Doctors to Stop Accepting Gifts from Drug Makers

Of course Gardiner Harris of the New York times came out with an article that the IOM report represents vindication for all things anti industry collaboration

In a scolding report, the nation’s most influential medical advisory group said doctors should stop taking much of the money, gifts and free drug samples they routinely accept from drug and device companies.

One interesting note is the quote from David Rothman:“With the I.O.M.’s endorsement, issues that were once controversial now are indisputable,” said Dr. David Rothman, president of the Institute on Medicine as a Profession at Columbia University. “Conflicts of interest in medicine are no longer acceptable.”

The opening sentence of the IOM report states:  Patients and the public benefit when physicians, researchers, collaborate with pharmaceutical, medical device and biotechnology companies to develop products that benefit individual and public health.

This is not exactly the same sentiment that Dr. Rothman portrays, he has staked his living on the COI debate for years, they did not go for the sever restrictions he has been calling for, perhaps this is a wakeup call that even Ethic’s purists can come to the same conclusions that he has in his Institute of Medicine as Profession reports, notice he uses a similar sounding name as IOM just to give himself more credibility, never quite getting to the truth.

Wall Street Journal: Institute Urges Strict Curbs on Medical Industry Perks

The Institute of Medicine recommended Tuesday that doctors, medical schools, professional groups and drug makers make far-reaching changes to prevent industry gifts and payments from influencing patient care and research.

Thomas Stossel, a professor at Harvard Medical School, criticized the proposal to cutback industry funding of doctor education because it would deprive physicians of a valuable source of up-to-date information about valuable treatments.

"There is no evidence for the need of these regulations," said Dr. Stossel, who said he has started companies and worked with industry. "It's high-end welfare for the ethicists and maybe job security for the academic administrators," he added.

Associated Press: Medical experts want crackdown on drugmaker money

Millions of dollars in gifts, travel and consulting fees from the pharmaceutical industry should be eliminated to stop companies from influencing how doctors practice medicine, a report by the government's top medical advisers says.

The sweeping recommendations from the Institute of Medicine call on medical professionals — from university professors to family doctors — to shun financial arrangements with companies that have flourished over the past three decades.

Taking free lunches from company salespeople, giving paid lectures on their behalf and other practices "erode public trust while providing no meaningful benefits to patients or society," institute panel chair Dr. Bernard Lo said in a statement.

The report calls on medical schools, hospitals and physician groups to:

• Publicly report funding they receive from companies.
• Not accept free meals, gifts or other items from companies.
• Prohibit doctors who have a financial conflicts of interest from testing new therapies on people.

Perhaps the most vigorously defended practice is company support for so-called continuing medical education conferences, where doctors learn about the latest treatments. Most state medical boards require physicians to attend a certain number of sessions each year to maintain their licenses.

While the panel stopped short of calling for a ban on industry-funded education, it stated that "a new system of funding ... should be developed that is free of industry influence

The AP story is accurate in the visceral nature of the press conference.

Jack Lewin, MD Chief Executive Officer of the American College of Cardiology was Quoted in every article:

"The acceleration of science is going to make it tougher and tougher for physicians, nurses and other health care professionals to stay current," said Dr. Jack Lewin, President of the American College of Cardiology.

In addition there is a great interview with Dr. Lewin and story on MedPage Today, I think he is leading the charge at medical societies to make changes that don’t hinder the advancement of science and risk patient care.

 

IOM Conflict of Interest: Medical Societies Respond to Report

The American College of Cardiology, American College of Emergency Physicians, American College of Radiology, American College of Rheumatology, American Gastroenterological Association, and American Society of Plastic Surgeons Issued a joint statement at the IOM press briefing on Conflict of Interest in Washington DC.

The statement calls for increased public support and shows the value of collaboration with industry to provide educational programs for their members.  They also recognize that philanthropic and government support is limited. 

Recently there have been a number of proposals to dramatically reduce or eliminate industry support for the activities of medical professional societies. In April, an article published in the Journal of the American Medical Association called for medical associations to sever most funding from industry, with the exception of journal advertising and exhibit hall fees. The Institute of Medicine is releasing a report today that also addresses these issues.

 

Medical professional societies can and do have ethical, positive relationships with industry, as do others in federal and state government and the foundation community. But public funding, particularly in the current economic climate, for education, quality initiatives and research is limited. Foundation and other such philanthropic support can only go so far.

 

Without continued external support from industry, our societies will be unable to provide the same level of outstanding education and cutting-edge science that has advanced the quality of patient care in this country. Moreover, as funding and reimbursements tighten, medical practices and practitioners are likely to fall further behind in offering the most current, evidence-based care to patients as the pace of scientific progress accelerates.

 

We would welcome more public support, however unlikely, for advancing quality, evidence-based care, and translation of science into clinical care guidelines. But, in the absence of public funding, industry funding can be separated from product bias and be firewall-protected to —

 

(1) support continuing medical education as a means to improve quality of care and outcomes;

 

(2) accelerate translation of science to the clinical care setting;

 

(3) support needed scientific and clinical research, as well as career development of young scientists;

 

(4) improve communication to patients about the benefits and risks of pharmaceutical/medical device products and equipment;

 

(5) improve patient and physician adherence and compliance; and

 

(6) address gaps in patient communication and education.

 

We are committed to the very highest ethical standards. We strive for responsible, transparent relationships, in which industry support has no influence on educational content, quality measures or scientific research. Our societies adhere to Accreditation Council for Continuing Medical Education standards, and we each have stringent internal policies that ensure that our educational and scientific content remain unbiased.

 

 Our industry supporters also adhere to guidelines from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Advanced Medical Technology Association (AdvaMed). Their guidelines reinforce the fact that interactions with health care professionals are designed to enhance the practice of medicine and benefit patients.

 

We are considering the development of an ad hoc self-funded coalition for medical associations to develop and articulate best practices and a common code of ethics for managing relationships with industry. Such core principles would include Transparency, Patient Centeredness, Active Management of Conflicts of Interest, and Accountability and Reporting.

We must and will continue to manage our relationships with industry responsibly, ethically and always in the best interests of patients. Until new sources of public funding for education and research are identified, these relationships will remain vital to the quality of care in the United States.

These medical societies recognize the value of collaboration with industry to improve their services to physicians for education and support.

Perhaps the ethicists at IOM forgot that practicing physicians need all the help they can get in providing high quality patient care, and right now the government is not stepping up to the plate to provide that support.

Institute of Medicine: Conflict of Interest in Medical, Research, Education and Practice

The Institute of Medicine: Conflict of Interest In Medical Research, Education and Practice Full Report  and Press Release  came out today and the report is over 300 pages long.

The report though lengthy is a re-hash of many of the themes we have seen from conflict of interest experts in the past few years, but the recommendations are presented with noticeable restraint.  It is clear that they have given consideration to what will happen if we pull out all industry ties with industry and that will be very difficult. 

Unfortunately their press conference on the report was a frontal assualt on all industry relationships with physicians and the presenters all conflict of interest experts (no practicing physicians), were on a one upmanship journey to see who is the most anti industry.

Bellow is a summary of the policy recommendations, which are not intended for the general reading audience.

Policy Recommendations:

3.1 Calls on all institutions engaged in these activities to establish conflict of interest policies and create conflict of interest committees to evaluate and manage conflicts.

 

3.2 Focuses on the essential policy step of requiring physicians, researchers, and senior officials to disclose to their institutions their financial relationships with industry. 

 

3.3 Calls for the standardization of disclosures with the goals of providing institutions with the specific information that they need to assess relationships while reducing the reporting burdens on physicians and researchers.

 

3.4 Calls for the U.S. Congress to create a national program that requires pharmaceutical, medical device, and biotechnology companies and their foundations to publicly report payments to physicians, researchers, health care institutions, professional societies, patient advocacy and disease-specific groups, providers of continuing medical education, and foundations created by any of these entities.

 

Research:

 

4.1 Calls for a general rule that researchers may not conduct research involving human participants if they have a financial interest in the outcome of the research, for example, if they hold a patent on an intervention being tested in a clinical trial. Exceptions should be allowed only if an individual’s participation is judged to be essential for the safe and appropriate conduct of the research.

Education:

 5.1: Therefore calls on academic medical centers to prohibit faculty, students, residents, and fellows from accepting gifts (including meals), making presentations that are controlled by industry, and claiming authorship for ghostwritten publications. This restriction is not intended to exclude the acceptance of scientific materials from industry scientists under-appropriate material transfer agreements or the payment of reasonable honoraria to speakers who present their own material. Recommendation 5.1 also calls for restrictions on the acceptance of pharmaceutical samples and visits by drug and medical device sales representatives

5.2 Calls on academic medical centers and teaching hospitals, as part of their educational mission, to provide education on the avoidance of conflicts of interest and the management of relationships with pharmaceutical and medical device industry representatives. Organizations that accredit medical schools and residency programs should develop standards to reinforce this

recommendation.

5.3 Calls for a broad-based consensus development process to propose a new system of funding accredited continuing medical education that is free of industry influence, enhances public trust in the integrity of the system, and provides high-quality education.

Some members of the committee supported a total end to industry funding, but others were concerned about the potential for unintended harm from such a ban. The committee recognized that changes in the current system likely would substantially reduce industry funding for accredited continuing medical education. Even if education providers trim their expenses, the costs of accredited continuing medical education would likely increase for many physicians, which could be an economic burden for some physicians, for example, those in rural areas.

 

Practice

6.1 (for faculty, students, residents, and fellows). Independent assessment of the evidence and the practice of evidence-based medicine are core competencies for physicians in clinical practice as well as academic practice; relationships with industry should not undermine those competencies.

 

6.2 Calls for further revisions to industry practices to be consistent with those outlined in Recommendation 6.1

 

Guidelines:

 

7.1 Calls on groups that develop guidelines not to accept direct funding for guideline development from industry and generally to exclude individuals with conflicts of interest from guideline development panels.

 

7.2 Calls for organizations that have an interest in the use of evidence based clinical practice guidelines to establish incentives to encourage the developers of guidelines to adopt the committee’s recommendations.

 

Institutions

 

8.1 Calls for the boards of trustees of institutions to establish a conflict of interest committee to make judgments about institutional relationships with industry, including the relationships of senior officials.

 

8.2 Calls for NIH to develop regulations requiring institutions covered by the 1995 PHS regulations to adopt institutional conflict of interest policies.

 

Supporting Organizations:

 

9.1 Proposes that groups such as accrediting organizations, public and private health insurers, and associations of medical journal editors develop incentives to make institutions more accountable for preventing, identifying, and managing conflicts of interest.

 

9.2, Calls for more research to assess the positive and negative consequences of

conflict of interest policies and provide a stronger evidence base for improving conflict of interest policies and their application

Overall this is a full throttled rehash of conflict of interest recommendations and it is clear from the tables that there is not a lot of evidence to back it up.   This report also could be tilted the economic stimulus package for conflict of interest experts, and the creation of conflict of interest jobs throughout the medical community.

The report also basically re-enforces the changes that PhRMA and AdvaMED have made with their codes of conduct, and the AAMC report on conflict of interest in medical education.

We will have a lot more to say once we work our way through the entire report….

The Institute of Medicine:

Conflict of Interest In Medical Research, Education and Practice Full Report  

Press Release 

Recommendations

Report Brief

IOM Press Conference (Audio)