Policy and Medicine

AMA CEJA: Taking a New Road on Commercial Support

According to Medical Meetings the AMA CEJA committee looks like they have taken the proposed ban on commercial support off the table for the upcoming CEJA report.  CEJA reported this in a progress update to the AMA at the AMA fall meeting recently held in Orlando, Florida.

CEJA’s report, “Industry Support for Professional Education in Medicine,” is a work in progress and is scheduled for release at the 2009 annual meeting next June. However, CEJA council member John McMahon, MD, corporate medical director, Mountain Pacific Quality Health Foundation, Helena, Mont., said that the council made clear in its progress update at the Interim Meeting that it does not support eliminating commercial support.

As  previously reported CEJA is revising the report and will be working with the AMA Council on Medical Education which will provide for a much more balanced report.

This past summer AMA CEJA’s report Industry Support for Professional Education in Medicine, was soundly rejected by their constituencies including, medical schools, associations, hospitals, and state medical societies.  Even the Medical Student Section came out against the report.  The reference committee had sent it back for more work.

The AMA CEJA and CME committees will be soliciting commentary from stakeholders on the issue of commercial support in CME, according to the staff the comment period is now open, so this is an opportunity to participate in the process.

Medical Meetings: CEJA Takes New Stance on Commercial Support

Policy and Medicine:  AMA CEJA: Round 2

                                     AMA CEJA:  Back to the Drawing Board

AMA CEJA: Round 2

This past summer the AMA CEJA committee proposed elimination of commercial support of CME. This was soundly rejected by the AMA Membership.

The AMA Committee on Ethical and Judicial Affairs and the AMA Council on Medical Education are now joining up to write companion reports on commercial support for medical education for the House of Delegates meeting in June of 2009. 

This proposal, to begin the process, will be presented at the AMA House of Delegate Interim Meeting, November 8-11, in Orlando, Florida.

Joint Report of the Council on Ethical and Judicial Affairs and the Council on Medical Education

CEJA Report 1-A-08, “Industry Support for Professional Education in Medicine” - Update (Informational)

The CEJA committee understands that the last version of the 2008 CEJA report received input that was significantly in favor of referral back to the committee. (Translation: almost everyone thought it was a bad idea.) CEJA was urged to more fully address potential different implications for different stakeholders in medical education and seek further input from stakeholders.

In view of these concerns, the Council on Ethical and Judicial Affairs and the Council on Medical Education (CME) discussed the issues raised by CEJA Report 1 (A-08) and concluded that those issues can best be addressed by the two Councils working together.  Each committee has unique roles and responsibilities to take advantage of their differing areas of expertise and focus.

CEJA and CME appreciate the unique roles and responsibilities of each Council. To take maximum advantage of their differing areas of expertise and focus, the Councils will develop complementary, companion reports that provide ethical analysis and recommended guidelines (CEJA) and empirical analysis of existing strong practices and strategic recommendations for implementing ethical guidelines (CME). It is CEJA and CME’s intention to present these reports to the House at its 2009 Annual Meeting.

To help inform their work, CEJA and CME will jointly solicit focused commentary on key issues relating to commercial support for medical education. Invitations to comment will be extended to interested stakeholders, including consumer/patient advocates as well as professional organizations, through an open call for response posted on the AMA website. The comment period will open immediately following the 2008 Interim Meeting.

To ensure effective collaboration, the Councils’ respective work processes and products will be coordinated by a small joint work group composed of the Chair and Vice Chair of CEJA, the Chair and Chair-Elect of CME, and at least one additional member of each Council. The work group members will serve as representatives of and liaisons to their respective Councils.

It is encouraging that the AMA committees are opening up the process for input.  The last CEJA report was poorly thought out and only served to incense large constituencies at the AMA.  We applaud the AMA for opening up the process.

We anticipate seeing a more balanced statement from the AMA committees this go around.

AMA 2008  Interim Meeting

Full Agenda

CEJA – CME informational report

Wisconsin State Medical Society: Dumping Gifts

This past week the Wisconsin Medical Society passed a voluntary ban on gifts to physicians becoming the first state medical society to enact such a ban.

The ban categorizes gifts as: “Physicians shall accept no gifts from any provider of products that they prescribe to their patients such as personal items, office supplies, food, travel and time costs, or payment for participation in on-line CME. A complete ban eases the burdens of compliance, biased decision making, and patient distrust.”

Could a complete ban be a cop-out for physicians in Wisconsin -- so they don’t have to make choices between right and wrong?   "If our doctors accept nothing then the problem will go away, and our patients will trust us."

In reality, if physicians in Wisconsin will focus on being the best there are with no exceptions, staying current with the literature, patients will trust them. 

The problem is not gifts, which PhRMA and their member companies unilaterally withdrew this summer, it is physicians who are having a hard time adjusting to modern medicine.

Your patients want to know that whatever you are giving or doing to them will help them live better lives, relieve their symptoms and save their lives.

In their list of gifts they mention payment for participation in on-line CME, until this morning I was unaware of this practice, I'm not sure if this refers to certified CME or what.

“This policy is strong and clear,” said Society President Steven Bergin, MD. “It leaves no doubt that the Society’s physicians want to prevent even the impression that a gift–no matter how small–could get in the way of a physician’s decision-making.”  (But where is the evidence to back up this decision? Where is the proof of patient harm?)

He also stressed that the policy should not be implied as a condemnation of any specific group or industry.   (Translation:  industry we still want your money, even though we just trashed you to our members and the press.)

“This policy simply puts the Wisconsin Medical Society on record that individual physicians should take a bright line approach to accepting items from companies that make products or drugs that the physician might end up prescribing or recommending to his or her patients,”

I am sure you will find this hard to imagine but I am not a fan of gifts, but I think individual physicians should be making this call, not the government or medical society, and often, as we see later in their recommendations, they confuse gifts with medical updates.

 

Dr. Bergin said. “There’s nothing more sacred than the physician-patient relationship, and we physicians have the responsibility to make sure nothing gets in the way of that relationship–or even appears to get in the way.”

 

Actually the most sacred part of that relationship is that what the doctor gives me or does for me helps me in the end.  Or at least to the best of his knowledge, and that he/she is current with the literature on what works best.

 

In the policy they then go on to quote “Medical philosophers from ancient to modern affirm the priority of patient interest as the cornerstone of medical professionalism and the first principle in resolving conflict of interest (COI) questions. …   (The ancient medical philosophers also killed most of their patients with unproven therapies, but hey, they practiced the art of medicine.  I am going to stick to science which helps people.  I guess the doctors in Wisconsin are nostalgic, their arguments from here are generally lacking.)

 

The remainder of the document is ad nauseam statements including:

 

High quality patient care and health outcomes depend on patient trust in physician advice.

 

COI is ubiquitous in human relationships, including the patient-physician relationship, therefore, the profession and each physician every day must strive to acknowledge and manage COI in order to prevent avoidable bias in medical decision making. A physician’s prescribing decision should be based on the best evidence available.

The reciprocal giving of gifts is an ancient human practice and likely has survival value by reinforcing social bonds. Health product companies have long offered gifts to physicians and the profession has long denied being influenced by these gifts. By distinguishing among possible gifts according to monetary value or value to patient care, ethicists have attempted to estimate the risk that specific gifts could bias medical decision making -- no doubt these distinctions have reduced the frequency of outrageous gifts, however, it is becoming apparent that any gift from a product provider to a product prescriber risks biased decision making, and at least, risks loss of patient trust in physician advice. Some conflicts can’t be avoided, but avoidance of unnecessary conflicts is the cornerstone strategy of professional conflict management.

 

An article found in JAMA 2006: 295: 429-433 (you read journal articles; you don’t find them) has renewed the western world’s conversation about the commercial relationship between health product industries and the profession of medicine. Following their recommendations, the Society affirms (affirm is not the same as recommend or require) the following examples of ethical professional behavior. (The article they quote is the Brennan paper which earlier this summer, Thomas Stossel, MD pointed out in an Medscape editorial was written with a predisposition to its conclusion and ignored all evidence to the contrary)

                 

The direct provision of drug samples to patients should be limited and, when possible, should be replaced by a system of vouchers for evidence-based drug choices.  (Try that one on the many patients who benefit by short term use of a drug or where you want to see if that drug has an effect.  They will all be clamoring for the extra step of going to the pharmacy to get a one week supply and the pharmacies look forward to all the free prescriptions they will have to fill)

 

Physicians serving on formulary committees who have any kind of commercial relationship with a health product company shall disclose any such relationship and recuse themselves from the formulary process, as necessary to avoid bias.

(This is one of the few Brennan recommendations, I would agree with.)

 

CME providers should not accept support from health product companies directly. A CME provider may create a fund for medical education that may accept unrestricted donations from health product companies that is then dispersed according to institutional policy; this policy, financial contributors and the amount of their contributions shall be disclosed as public information on an easily accessible Web site.   (Just give us the money and we will do something good with it.  Of course no charities, governments, corporations or foundations are foolish enough to just give you the money….)

 

Physicians should not serve as members of speaker bureaus for health product companies or their contractees. (They affirm the Brennan argument that physicians shouldn’t speak on behalf of a product even if they believe it will save the patient’s life or increase their well being; this is utter nonsense.)

 

Physicians should not allow their names to be listed as authors for articles written by health product company employees, a practice called “ghostwriting.”  

(Ghost writing sounds awful, but in many cases the physician researcher may not be the best writer.  Research and education are collaborative efforts and may require a whole team to best analyze a study, so that just one researcher's bias is not presented or written.  Often the peer reviewers are not looking at the raw data, so this extra step of multiple views, i.e. ghost writing, is probably more beneficial than harmful to the enterprise.)

 

Since ethical collaboration between the profession and the health product industry is essential for the continued development of health products, high-integrity consulting and research relationships shall be strongly encouraged.

(This is absolutely correct.  We all need each-other to develop the next best medicines.)

 

However, to avoid such relationships being tantamount to a gift, such relationships shall be based in contracts for specific “deliverables” in return for just compensation. (Everyone wants just compensation, the problem lies when the government decides what that should be)

 

The whole concept of gift bans and pledges like the Wisconsin Medical Society enacted, are based on supposition that only one party (the patient) should benefit from the practice of medicine and all others (physician, manufacturer, hospital, health plan), should have no benefit.

 

The following office sign is available for members of the Wisconsin Medical Society:

 

Office Sign:

 

TO OUR PATIENTS

To uphold the highest standards of our Profession,

To ensure our advice is based solely on what’s best for you, and

To enable your highest level of trust in our advice,

We follow the recommendations of the Wisconsin Medical Society,

And accept no gifts from any provider of a product that we prescribe or recommend to you.

We are offering an alternative sign for offices in Wisconsin:

 

Alternative Office Sign:

 

TO OUR PATIENTS

To uphold the highest standards of our Profession,

To ensure our advice is based on sound scientific evidence and what is best for patients,

To enable your highest level of trust in our advice,

We will do everything in our power to stay current with the latest scientific literature, to discuss scientific topics with as many reliable sources as possible.

Since we are not all knowing, we welcome you pointing out to us any articles that you think may be applicable to your condition.

 

We have also thought about what the sign will be like in the year 2018.

 

Office Sign (Year 2018)

TO OUR PATIENTS

To uphold the highest standards of our profession

To ensure our advice is based solely on information we acquired twenty years ago.

So you won’t have trust in our advice anyway

We follow at the detriment to ourselves, families and community the recommendations of the Wisconsin Medical Society

And accept no gifts, no payment for services or other compensation whatsoever. 

If you feel led please leave a few dollars by the door on your way out, and please excuse our lack of staff and lights, for without compensation those are not necessary.

Please let the Wisconsin Medical Society know you appreciate the free service.

 Starting next week we will be practicing in a shack, five miles down the road.

If you are with the student loan company or others looking for payment please disregard the previous sentence.

 

 

Wisconsin Medical Society:  Gift Ban

Wisconsin Medical Society: Press Release

Wisconsin Medical Society: Home Page

Medscape Editorial: Response to AMA's Council on Ethical and Judicial Affairs Draft Report on "Ethical Guidance for Physicians and the Profession With Respect to Industry Support for Professional Education in Medicine"

AMA CEJA – Back to the Drawing

Today the AMA House of Delegates soundly rejected the CEJA recommendations Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine and sent them back for further study and without objection.  This closes this chapter on the issue of funding for Continuing Medical Education.

Earlier in the day the Reference Committee on Amendments to Constitution and Bylaws, “recommended for referral” what was formerly identified as CEJA Report 1, so that it will not be presented on the house floor for a vote.

However, because the Reference Committee did not  “recommend for not adoption”,  CEJA can revise and (improve) their report for presentation at a later meeting as soon as this time next year.

We don’t believe however, given the strength of almost unanimous opposition to the recommendation, that this issue will come back to the House of Delegates anytime in the near future.

At the reference committee hearing on Sunday only two speakers spoke in favor of adoption of the report; the current CEJA chairman Mark Levine, MD (according to our sources he is retiring after this meeting) and one other physician who apparently speaks against everything given the opportunity. 

One interesting note, according to one source when Doctor Levine stood up at the support microphone to present the report, he told the Chairman of the reference committee Dr. Raymond Christenson, that he would not take up much time given all those who were behind him in favor of the proposal, at which the chairman noted, Dr. Levine there is no one behind you, so take your time.

Almost 40 individuals representing most of the major constituencies at the AMA, came to the microphone to speak out against this report. The First speaker was the President of the Organization of State Medical Association Presidents (OSMAP) speaking on behalf of the state medical associations, others from the Medical Student Section (MSS) (which gives us hope given the extreme stances that the American Medical Student’s Association has taken on issues similar to this one), The Minority Affairs Consortium (MAC), the National Medical Specialty Societies and many more.    John Kamp the executive director of the Coaltion for Healthcare Communications, noted conflicts of interest exist in all circumstances and that the treat of lawsuit by trial lawyers, creates a conflict of interest in physicians in the way they practice and ordering what tests.

One exceptionally compelling testimony came from the Edward Langston, MD, Chairman of the AMA Board of Trustees who gently urged Dr. Raymond Christensen, Chairman of the Reference Committee to “accept the Committees recommendation for referral” and by doing so “preserve the sanctity of CEJA” (largely because the report on which the recommendation was based, was so biased against any value to collaboration).

Thanks to all the groups who recognize the value of collaboration and took the effort to speak out against this report by working hard to develop very thoughtful positions on the issue. 

We wish Doctor Levine well in his retirement, and though we don’t agree with his proposed recommendations for change, we admire and share his commitment to improving the practice of medicine and dedication to patient care.

As we move on we need to recognize that the most important issue is that doctors learn and implement the most up to date medicine regardless of who supports it.

AMA CEJA – Former JAMA editor suggest withdrawal

George Lundberg, MD Editor of Medscape Journal of Medicine and former Editor and Chief of the Journal of the American Medical Association (JAMA) discusses the conflict of interest recommendations including the AMA CEJA

Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine in The Medscape Journal of Medicine, Responding to the American Siege Against Continuing Medical Education.

His insightful commentary includes the following statement about the CEJA recommendations:

“It reads like something from 1-2 decades ago, before the numerous current CE safeguards were instituted.”

He goes one step further than others in recommending that “CEJA should withdraw this report before the meeting and bring stakeholders together to strive for a more informed revision for possible presentation at a later date”

Responding to the American Siege Against Continuing Medical Education

AMA CEJA -- A Chorus of Voices Say (Vote NO)

A group of key influential leaders in CME along with others are standing up to ask the AMA House of Delegates to reconsider Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine

The National Task Force on CME Provider/Industry Collaboration.

An important group in the CME community, The Task Force, is an organization of nearly 50 senior professionals in CME who represent themselves, but have distinguished careers and vast experience with CME in medical schools, specialty and other societies, accrediting agencies, state medical groups, CME providers, grantor companies, and other industry organizations.

• The report (and related Q & A included in the HOD material) does not sufficiently distinguish between certified CME.

While the report recognizes possible bias and conflict issues arising from the pharmaceutical and medical device industries, it ignores all other sources of bias and conflict.

• The report is not based on scientifically rigorous and relevant contemporary data.

• While the report would effectively eliminate over one billion dollars of commercial support for certified CME, it offers no plausible substitute for that support.

• The AMA need not seek to eliminate industry support while significant government, industry and other stakeholders – including those supported by existing AMA programs – are effectively improving the quality and effectiveness of CME and improving on the management of potential bias and conflicts.

• We agree with the suggestions in CEJA recommendation #4 to focus on patient care and encourage more effective models of education, more attention to educationally underserved physicians or areas, and a balance of funding less reliant on industry. However, we believe that elimination of industry support actually undermines these goals.

• In short, while ethical lapses have occurred and need to be fully addressed by individual doctors and the community, the certified CME enterprise has and is making significant progress on conflict of interest issues.

Testimony for the Reference Committee on Amendments to Constitution and Bylaws

Arnold Friede, a health care attorney with the law firm of McDermott, Will and Emery and former Deputy Chief Council at the Food and Drug Administration (FDA) urged the American Medical Association (AMA) Reference Committee on Amendments to Constitution and By-laws not to adopt the recent Report of the Council on Ethical and Judicial Affairs (CEJA) on "Industry Support of Professional Education in Medicine," and to refer the matter for further study.

Key points include:

·         The procedures used by CEJA to develop the recommendations in the Report lacked due process.

·         In concluding that conflicts cannot be managed and must be eliminated entirely, the CEJA Report is at odds with other thoughtful recent recommendations from organizations with comparable interests.

·         The CEJA Report fails to identify and consider the serious collateral implications of its recommendations.

Friede Letter to AMA leadership

John Kamp the executive director of the Coalition for Healthcare Communications, was interviewed by Medscape on the issue of the Conflict of interest recommendations. 

Let's Get Real About Conflicts of Interest in Medicine

AMA CEJA – How Did We Get Here

Thomas Stossel, MD, Chairman of the Division of Translational Medicine at Harvard has written a very insightful editorial published today in the Medscape Journal of Medicine: Response to AMA's Council on Ethical and Judicial Affairs Draft Report on "Ethical Guidance for Physicians and the Profession With Respect to Industry Support for Professional Education in Medicine" around the origins of controversies surrounding The CEJA Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine and conflict of interest and the wholesale ethnic cleansing associated with it.

Enactment of these regulations will have profound practical consequences for medical education, and stakeholders concerned about these effects should address them in detail. My intention here, however, is to challenge the fundamental beliefs underlying The Report that transcend medical education to affect medical practice and medical research in general. These beliefs are that commerce in general is detrimental to medical professionalism and that "medicine" and "commerce" have sufficiently misaligned interests to justifying their segregation from one another. Such segregation is increasingly becoming policy in academic medical centers in the form of severe prophylactic laws impinging on physicians' freedom of association and action, and similar rules are under consideration in state legislatures and in the Congress.

His insightful editorial challenges the concept of “professionalism free of any commercialism”.  He goes right to the start of this recent controversy in the Brennan report Health Industry Practices That Create Conflicts of Interest published in JAMA in 2006.

I first show that Brennan and colleagues and the derivative Report failed to place their "concerns" in terms of a balanced risk-benefit assessment, and that such an analysis does not support their assumptions or the recommendations. I then argue that Brennan and colleagues and The Report based their conclusions on an arbitrary, obsolete, and frankly untenable definition of professionalism.

He outlines a realistic view of medical education: "absence of bias," is impossible and therefore inappropriate as a criterion for professionalism.

This article promises to be a foundational report to helps us understand the value of collaboration.

By working together with industry colleagues, we can explain to the public that the contributions of corporations to medicine are on balance more beneficial than harmful and that both medicine and the industries that provide it with its technologies are worthy of public support. Cooperation, instead of antagonism, can help industry market its products with the highest integrity, keep physicians current on the best available evidence, and provide excellent patient care. This plan, not woolly ethical generalities, is the proper model of medical professionalism.

We challange those who disagree with our position to read his editorial .  This article may change the way you think.  Enjoy…

Medscape Journal of Medicine Stossel Commentary

AMA CEJA -- Doctors Say Vote NO

For the last Sevin days, Medscape has asked physician’s their thoughts on AMA CEJA recommendations to ban commercial support of CME and the answer was resounding (House of Delegates Vote No)

At its June 14-18 annual meeting, the AMA will consider its ethical council’s call for a ban on industry support of CME for physicians, medical schools, teaching hospitals, and societies. Critics say the ban would reduce the availability and quality of CME and increase its cost. Do you favor or oppose such a ban on industry support of CME?

Favor

19%  (451)

Oppose

80%  (1844)

Link to Medscape Poll

AMA CEJA -- More Groups Line Up Against

In the last few days, two organizations:  the AAMSE and ACME, released their positions on CEJA: Report 1 of The Council on Ethical and Judicial Affairs: Industry Support of Professional Education in Medicine

American Association of Medical Society Executives (AAMSE) is a professional organization of approximately 900 medical society executives and staff specialists who represent more than 380 physician member organizations. Member organizations include county, regional, state, state specialty, national, national specialty and international medical societies, as well as affiliated healthcare organizations and industry partners. AAMSE AMA CEJA Position Letter

The Alliance for Continuing Medical Education (Alliance) is an international membership organization of more than 2,500 professionals from medical schools, hospitals, specialty societies, state medical societies, medical education and communication companies, pharmaceutical and medical device companies, and related organizations devoted to designing and implementing continuing medical education (CME) activities for physicians. Alliance AMA CEJA Response

Other groups that have recommended rejection of the CEJA recommendations include:

North American Association of Medical Education and Communication Companies, Inc. (NAAMECC), the trade organization for medical education and communication companies, and the Coalition for Healthcare Communication (CHC) NAAMECC Coalition CEJA Letter

Council for Medical Specialty Societies (CMSS) with 32 medical specialty society members representing more than 500,000 physicians. CMSS AMA CEJA Letter

The basic reasons for rejection include:

• Respectfully disagree with the Council’s conclusions and must oppose the report’s primary recommendation, specifically that “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.”
• Great effort has taken place to by CME providers to comply with the ACCME Standards for Commercials Support.  There have been substantial improvements in regulating CME in the last few years. CME providers have committed substantial resources to eliminate “commercial bias”.
• The report makes no distinction between Certified CME Activities and Promotional Programs.
• There would be a great financial and resource burden created on the medical system by adoption of this report.
• There have been no viable alternatives suggested by the report. 

AMA CEJA – Medical Specialty Societies Say Vote No

The Council for Medical Specialty Societies (CMSS) an organization representing medical societies with over 500,000 physician members, released their letter outlining their position on the CEJA Report Industry Support of Professional Education in Medicine.

Their position was a resounding no:

“CMSS  does not support recommendation 1 b) of CEJA Report 1-A-08, and therefore cannot support adoption by the AMA House of Delegates of AMA CEJA Report 1-A-08 in its current wording.”

They had significant concerns with the report:

“The report, unfortunately, fails to distinguish between promotional activities and certified CME.” 

CMSS also went into great lengths to show how much effort has gone into “fixing the system” to protect against bias especially since the Senate Finance Committee Report and the new ACCME Guidelines for Commercial Support.

They bring up some very good points on the outcome of such a proposal.

The potential unintended consequence of adoption of CEJA recommendation 1 b):

The elimination of commercial support for certified CME will significantly reduce the availability of certified CME, produced by accredited CME providers, such as medical specialty societies.

We expect the funds previously devoted to this support will be channeled by industry to promotional activities, including promotional educational activities for physicians.

In short, the result of adoption and implementation of CEJA recommendation 1 b) will likely be a rebalancing of education for physicians, with significantly less unbiased certified CME and significantly more biased promotional education.

We applaud the efforts of CMSS to bring a balanced perspective to such an important issue.