Policy and Medicine

American Medical Association: Launches Improving Health Outcomes Initiative

To bolster ongoing efforts to address the leading causes of suffering and death in our nation and to engage the physician community in improving national health outcomes, the American Medical Association (AMA) recently announced the first phase of its new multi-year, multi-million dollar improving health outcomes (IHO) initiative: preventing cardiovascular disease and type 2 diabetes and improving health outcomes for those with these conditions. 

“Cardiovascular disease accounts for one-third of all deaths in our nation, and one-in-three adults could have diabetes by 2050 if current trends continue,” said AMA President Jeremy Lazarus, M.D. “The toll of these diseases on our nation is staggering – in terms of human suffering and health care costs. T he direct and indirect cost of cardiovascular disease and diabetes is more than $535 billion a year.” 

The AMA’s efforts will include working closely with ongoing national programs, galvanizing America’s physicians and patients to focus on preventing and controlling cardiovascular disease and diabetes and teaming with new partners to address high blood pressure and prediabetes. 

“When America’s physicians work together with patients, communities and other members of the health care team we can have a tremendous impact on health outcomes,” said Dr. Lazarus at the National Summit on Health Disparities hosted by the National Minority Quality Forum.  “We will begin our new initiative with a focus on risk factors for cardiovascular disease and diabetes, aiming for optimal blood pressure, blood sugar and cholesterol levels for all U.S. adults.” 

The AMA chose the National Summit on Health Disparities to launch its effort as rates of diabetes are higher in Native American, African American and Latino communities, and African Americans are more likely to have cardiovascular disease.  

Cardiovascular Disease 

The key to preventing cardiovascular disease is preventing and treating high blood pressure.  One-in-three U.S. adults has high blood pressure, the number one risk factor for disability and death.  The AMA is partnering with the Armstrong Institute for Patient Safety and Quality, a research institute within Johns Hopkins Medicine, to help meet and exceed the goal of the U.S. Department of Health and Human Services’ Million Hearts Initiative to bring the high blood pressure of 10 million more Americans under control by 2017.  

AMA and the Armstrong Institute will work with physicians, care teams, patients and communities to better understand the reasons for uncontrolled blood pressure, find clinically meaningful solutions and share lessons learned. 

Directed by Peter Pronovost, senior vice president for patient safety and quality at Johns Hopkins Medicine, the Armstrong Institute is best known for its successes in dramatically reducing central-line associated bloodstream infections in hospital ICUs. The Armstrong Institute is committed to eliminating preventable harm for patients, optimizing patient outcomes and experience and reducing waste in health care delivery. 

Diabetes 

One-in-three U.S. adults has prediabetes, a condition in which blood sugar is higher than normal but not yet in the diabetic range.  Those with prediabetes are at greatly increased risk of developing type 2 diabetes.  The AMA’s initial efforts to help prevent diabetes will be in support of the Centers for Disease Control and Prevention’s (CDC) National Diabetes Prevention Program.  The CDC encourages physicians to refer patients with prediabetes to an evidence-based lifestyle change program that helps increase physical activity, improve diet and achieve moderate weight loss, which reduces the risk for type 2 diabetes.  

In partnership with the YMCA of the USA, the AMA will work to increase physician referrals of patients with prediabetes to the evidence-based diabetes prevention programs offered by the YMCA. 

“We are excited to work with the AMA on our shared goal of preventing diabetes. Connecting physician practices to the YMCA’s Diabetes Prevention Program will ensure that those at greatest risk have the opportunity to prevent or delay diabetes,” said Jonathan Lever, vice president of health innovation and strategy, YMCA of the USA. “This novel collaboration between medical practices and community-based programs could prove to be a model for promoting health and wellness.”  

“These are the first steps toward the AMA’s ambitious, long-term goal of achieving measurable improvements in health outcomes for patients in the United States,” said Dr. Lazarus. “We look forward to partnering with many individuals and organizations who share these goals.” 

The IHO initiative is one of three parts of the AMA’s new five-year strategic plan, which includes improving patients’ health outcomes, accelerating change in medical education and enhancing practice sustainability and physician professional satisfaction – all critical factors in optimizing the health of our nation.

 

Choosing Wisely: Associations Join to Educate Physicians and Pateints on Unnecessary Tests and Treatments

A recent initiative lead by the American Board of Internal Medicine Foundation (ABIM Foundation) and in partnership with Consumer Reports, aims at reducing unnecessary medical treatment, which some estimate constitutes one-third of medical spending in the U.S.  This includes unnecessary hospitalizations and tests, unproven treatments, ineffective new drugs and medical devices, and futile care at the end of life.  Some claim that doctors perform 45 common tests and procedures less often. 

The initiative, called Choosing Wisely, urges patients to question these services if they are offered.  The initiative has garnered 9 professional medical specialty partners with 8 others preparing to follow.  These partners include: 

• American Academy of Allergy, Asthma & Immunology
• American Academy of Family Physicians
• American College of Cardiology
• American College of Physicians
• American College of Radiology
• American Gastroenterological Association
• American Society of Clinical Oncology
• American Society of Nephrology
• American Society of Nuclear Cardiology 

These specialty societies represent 374,000 physicians.  Each society has developed a list of "Five Things Physicians and Patients Should Question" which patients can access from the choosingwisely.org website.   Additionally, eight new specialty societies have joined the campaign and will be releasing lists in fall 2012: 

• American Academy of Hospice and Palliative Medicine
• American Academy of Otolaryngology–Head and Neck Surgery
• American College of Rheumatology
• American Geriatrics Society
• American Society for Clinical Pathology
• American Society of Echocardiography
• Society of Hospital Medicine
• Society of Nuclear Medicine  

A recent article in the Journal of the American Medical Association (JAMA), also discussed the new initiative.  The article explained how the origins of this campaign are from the “Medical Professionalism in the New Millennium: A Physician Charter.”  Authored in 2002 by the ABIM Foundation, American College of Physicians Foundation, and European Federation of Internal Medicine, the charter has as its fundamental principles the primacy of patient welfare, patient autonomy, and social justice. 

It articulates the professional responsibilities of physicians, including a commitment to improving quality and access to care, advocating for a just and cost-effective distribution of finite resources, and maintaining trust by managing conflicts of interest.  The charter's commitment to a just distribution of finite resources specifically calls on physicians to be responsible for the appropriate allocation of resources and to scrupulously avoid superfluous tests and procedures. 

“Overuse is one of the most serious crises in American medicine,” said Dr. Lawrence Smith, physician-in-chief at North Shore-LIJ Health System and dean of the Hofstra North Shore-LIJ School of Medicine, who was not involved in the initiative.  “Many people have thought that the organizations most resistant to this idea would be the specialty organizations, so this is a very powerful message.”

“Many previous attempts to rein in unnecessary care have faltered, but guidance coming from respected physician groups is likely to exert more influence than directives from other quarters.  But their change of heart also reflects recent changes in the health care marketplace.” 

The list of tests and procedures they advise against includes EKGs done routinely during a physical, even when there is no sign of heart trouble, M.R.I.’s ordered whenever a patient complains of back pain, and antibiotics prescribed for mild sinusitis — all quite common.

The American College of Cardiology is urging heart specialists not to perform routine stress cardiac imaging in asymptomatic patients, and the American College of Radiology is telling radiologists not to run imaging scans on patients suffering from simple headaches.  The American Gastroenterological Association is urging its physicians to prescribe the lowest doses of medication needed to control acid reflux disease.

Even oncologists are being urged to cut back on scans for patients with early stage breast and prostate cancers that are not likely to spread, and kidney disease doctors are urged not to start chronic dialysis before having a serious discussion with the patient and family.

Other efforts to limit testing for patients have provoked backlashes.  In November 2009, new mammography guidelines issued by the U.S. Preventive Services Task Force advised women to be screened less frequently for breast cancer, stoking fear among patients about increasing government control over personal health care decisions and the rationing of treatment.

“Any information that can help inform medical decisions is good — the concern is when the information starts to be used not just to inform decisions, but by payers to limit decisions that a patient can make,” said Kathryn Nix, health care policy analyst for the Heritage Foundation a conservative research group. 

“With health care reform, changes in Medicare and the advent of accountable care organizations, there has been a strong push for using this information to limit patients’ ability to make decisions themselves.” 

Some of the tests being discouraged — like CT scans for someone who fainted but has no other neurological problems — are largely motivated by concerns over a malpractice lawsuits, experts said. Clear, evidence-based guidelines like the ones to be issued Wednesday will go far both to reassure physicians and to shield them from litigation. 

“These all sound reasonable, but don’t forget that every person you’re looking after is unique,” said Dr. Eric Topol, chief academic officer of Scripps Health, a health system based in San Diego, adding that he worried that the group’s advice would make tailoring care to individual patients harder.  “This kind of one-size-fits-all approach can be a real detriment to good care.”

Cancer patients also expressed concern that discouraging the use of experimental treatments could diminish their chances at finding the right drug to quash their disease.

“I was diagnosed with Stage IV breast cancer right out the gate, and I did very well — I was what they call a ‘super responder,’ and now I have no evidence of disease,” said Kristy Larch, a 44-year-old mother of two from Seattle, who was treated with Avastin, a drug that the F.D.A. no longer approves for breast cancer treatment. “Doctors can’t practice good medicine if we tie their hands.” 

“By identifying tests and procedures that might warrant additional conversations between doctors and patients, we are able to help patients receive better care through easy-to-use and accessible information,” said James A. Guest, J.D., president and CEO of Consumer Reports. “We’re looking forward to being a part of this innovative effort working with the ABIM Foundation, the specialty societies, and our eleven consumer communications collaborators to get this important message out to diverse populations of patients.”

American Academy of Neurology and Industry Collaboration

With the increased scrutiny on physician-industry collaboration and relationships, physicians, academic medical centers, and professional medical associations (PMAs) are beginning to feel the pressure to improve their policies and become more transparent.  A recent article reviewed the confluence of interest policies for the American Academy of Neurology and its affiliated organizations (AAN).  

The article highlights the response of the AAN to the heightened concern about industry COI through an AAN Board of Directors–appointed task force, a review of existing policies, and the implementation of newly revised policies governing AAN relationships with industry. 

Background and Summary  

AAN has relationships with industry, including pharmaceutical and medical device manufacturers and other medically related commercial product and service companies, which have mutual benefits, but can carry the risk of conflicts of interest (COI).  COI may cause unintended harm by creating bias, favoritism, undue influence, and a resulting loss of public and member confidence in the integrity and objectivity of the AAN.  In recognition of these risks, the AAN has longstanding policies to prevent and limit COI and their consequences, including strict enforcement mechanisms to guarantee that the policies are followed. 

The authors of the article reviewed the AAN′s polices governing its interactions with industry, mechanisms for enforcement, and the recent findings of the board-appointed COI task force, in the context of the 2009 David Rothman and colleagues' article in JAMA, the Council of Medical Specialty Societies (CMSS) Code for Interactions with Companies (Code), efforts of the American Medical Association in this area, and increased public and Congressional scrutiny of physician/physician organizations' relationships with industry. 

With respect to continuing medical education (CME), AAN policy and practices are congruent with the principles identified in the CEJA Report 1-A-11, “Financial Relationships with Industry in Continuing Medical Education:” minimizing industry influence on programming, transparency for learners, firewalls between industry and program development. H aving zero industry involvement with CME programming is a sound aspirational goal, as noted by CEJA.  However, the article recognized that,” having industry support does not present a prima facie unethical situation and the integrity of the AAN can be protected with appropriate measures (as outlined in the Principles, CEJA report, and ACCME Standards).” 

The AAN′s Policy on Conflicts of Interest provides four mechanisms for addressing COI: avoidance, separation, disclosure, and regulation.  The authors concluded that, “Complete avoidance of relationships between the AAN and industry is not a reasonable strategy because areas of appropriate mutual gain would be sacrificed unnecessarily and because effective and less radical remedies are available.” 

Rothman and colleagues identified several guiding principles to consider when addressing relationships with industry, which the AAN supports: transparency, diversification of support, and firewalls to prevent inappropriate influence on programs and publications.  However, the AAN disagreed with some of Rothman and colleagues' recommended methods for enacting these principles.  For example, AAN, along with the CMSS Code signatories, believe a complete ban on funding “stifles a mutually beneficial relationship between PMAs and industry in which the two groups share a common interest of supporting patient well-being and medical innovation, with an understanding that these relationships must be highly regulated.” 

The AAN′s Principles Governing Academy Relationships with External Sources of Support, including recent amendments proposed by the COI task force, regulate industry interaction with AAN programming, products, and leadership.  With the Policy, Principles, and other methods of COI prevention, the AAN meets or exceeds all recommendations of the CMSS Code. 

“With its adherence to the Principles since 2004, the AAN has been a leader among professional medical associations in appropriately managing COI related to interactions with industry,” the article concluded.  Recent amendments to the Principles maintain the AAN′s position as a leader in a time of increased public scrutiny of physicians' and professional medical associations' relationships with industry.  The AAN is responsive to the recommendations of the COI task force, and has adopted the CMSS Code. 

Study and Review of AAN COI Policies 

AAN promotes the highest quality patient-centered neurologic care and enhances member career satisfaction through providing education, information, policy development, and advocacy for AAN members and patients; by setting and maintaining the highest ethical and professional standards for members, staff, and programs; and by upholding the integrity of the AAN and keeping the interests of patients first. 

Pharmaceutical and medical equipment manufacturers strive to benefit patients by providing products and services that help physicians diagnose, treat, and rehabilitate patients.  To carry out the AAN′s mission, its members prescribe industry-developed treatments that their patients need and use.  Therefore, the article recognized, “relationships between the AAN and industry are natural and mutually beneficial.” 

The principal risk in AAN–industry relationships is the development of COI that jeopardize AAN′s mission.  The article defined COI as “situations in which professional judgment concerning a primary interest such as patient welfare is unduly influenced by a secondary interest such as financial gain.”  COI are a serious problem for physicians if they demote the primacy of the patient's interests and if their presence diminishes the overall confidence that patients and the public have in the medical profession.  For medical societies such as the AAN, COI could diminish the confidence of AAN members, patients, and the public in the AAN′s integrity and could jeopardize the AAN′s core value to keep the interests of patients first.

Relationships with industry can produce COI or the appearance of COI, if AAN members, patients, or the public believe that the AAN has sacrificed its credibility and integrity by promoting the interests of industry for its financial gain.  The use of industry support to offset costs of AAN programs and offerings makes the issue of maintaining our organizational independence, credibility, and integrity a serious ongoing concern. 

This concern is magnified by the national publicity generated by current inquiries by the United States Congress into relationships between physicians and industry, and between medical associations and industry, in which all relationships are suspect, scrutinized, and publicized.  This trend of increasing public scrutiny makes even the appearance of COI a liability for the AAN. 

The AAN Board of Directors and the AAN Ethics, Law and Humanities Committee previously established policies addressing AAN relationships with industry and COI: the Principles Governing AAN Relationships with External Sources of Support, first published in 2004, and the Policy on Conflicts of Interest, substantially amended in 2008.  In response to the article by Rothman et al. and the contemporaneous COI policy formulation by the CMSS, AAN leadership commissioned an ad hoc task force in 2009 to 1) evaluate the extent of AAN-industry relationships; 2) review existing AAN policies that regulate the relationships in the context of policies of other professional medical associations and prevailing ethical standards; and 3) make recommendations to limit COI in such relationships. 

The task force made their recommendations from their findings in the form of proposed amendments to the Principles Governing AAN Relationships with External Sources of Support.  The revised Principles document was approved by the AAN Board of Directors and adopted by the AAN Foundation Board of Trustees in June 2010.

The task force found many of AAN′s existing policies and practices to be proficient in appropriately preventing or managing COI related to AAN relationships with industry and consistent with prevailing codes and standards (including ACCME standards and aspects of the Rothman et al. article and the CMSS Code). 

The article noted that public disclosure of COI is an essential step but only mitigates the COI by making others aware of it.  Regulation is a necessary strategy to promote mutual interests while minimizing the possibility of COI.  Regulation requires the drafting of effective policies and their vigilant enforcement.  The Principles Governing Academy Relationships with External Sources of Support is the AAN′s primary policy in providing such regulation. 

In 2004, the AAN Board of Directors approved the Principles Governing AAN Relationships with External Sources of Support, which outline six principles and eight special guidelines to be observed when establishing and maintaining relationships with external sources of support, including industry supporters.  The task force also added a section to the Principles specifically outlining special guidelines concerning AAN relationships with industry in particular contexts involving industry (e.g., CME programming, advocacy training, guideline development and dissemination, exhibit hall activities). 

The task force identified several goals they felt would be met by their proposed amendments to the Principles.  All AAN policies governing relationships with industry must be transparent to members and the public.  These policies must assure that any financial support of the AAN by industry is not conditional on any real or implied quid pro quo.  Industry monies or representation ought not to influence AAN administration, policies, services, practices, or educational activities.   

AAN policies should address the public relations issue of the appearance of COI or undue influence.  Such influence grows in magnitude in proportion to the extent of AAN financial relationships with industry.  AAN policies governing relationships with industry should be configured to allow appropriate areas of mutual benefit while, most importantly, maintaining the AAN′s high ethical and professional standards and protecting its most valuable and cherished asset, its credibility and integrity as a PMA. 

AAN and CMSS regulate through policies that require society control over education programming, transparency of industry funding for programming and publications, disclosure or recusal by faculty and guideline authors, and overall prevention from over-reliance on industry funding for operations.  Evidence of AAN enforcement of such policies is AAN′s 2011 reaccreditation with commendation by the ACCME—demonstrating AAN′s compliance with ACCME's criteria.  In addition, AAN support from industry was well below that recommended by Rothman et al.: 18% in 2009 and 17% in 2010 (including journal advertising revenues and meeting exhibits—both excluded from the calculations recommended by Rothman et al.). 

The Principles expressly prohibit the AAN from accepting industry funding for development and initial distribution of guidelines.  Since adoption of the CMSS Code, the AAN requires a majority of the guideline development panel members to be free of COI relevant to the subject matter of the guideline.  In addition, the chair of the panel (or at least one of the chairs, if multiple) is required to be free of COI.   

Conclusion 

Ultimately, AAN should be encouraged for their approach to maintaining physician-industry relationships, while promoting transparency.  The concern is that organizations can engage in group think , often ignoring the benefits of collaboration in attempt to appease their critics. 

The statements made in this article reflect their understanding of the important role physician-industry collaboration can have, and the dedication and oversight needed to ensure such relationships continue ethically to benefit patients.  Other PMA’s should look to this article and AAN for guidance on how to continue collaborating with industry through thoughtful, reasonable COI policies. 

Specialty Societies and Patient Advocates Contribution to Comparative Effectiveness Research

A recently article in Health Affairs explained how, “Specialty societies and patient advocates have critical roles to play to help accelerate the benefits of comparative effectiveness research (CER).” 

Specialty societies are a “trusted intermediary that can convey the views of practicing physicians to those sponsoring and conducting research, disseminate research findings widely and effectively, and foster conversations about the research and its importance between patients and physicians.” 

Patient advocates can explain the importance of CER to their constituents, helping to address fears that some may have that CER is a tool to deny needed care.  They can also disseminate specific findings to educate patients about the sorts of interventions they should (and should not) request. 

The authors of the article suggest ten specific steps that specialty societies and patient advocates can take to promote the use of CER. 

The authors include include Norman Kahn, MD, Executive Vice-president and Chief Executive Officer of the Council of Medical Specialty Societies (CMSS); John Rother, JD President and CEO of the National Coalition on Health Care; Timothy Lynch, JD, Director of Foundation Programs for the ABIM Foundation; David Hoyt, MD, Executive Director of the American College of Surgeons; and Steven Weinberger, MD, Executive Vice President and Chief Executive Officer of the American College of Physicians.

The Research

Specialty societies and patient advocates should urge the Patient-Centered Outcomes Research Institute (PCORI) and other entities sponsoring CER to ensure patients and clinicians play active roles in designing CER studies and identifying the research questions to be studied. 

Studies should be designed to inform the real-world decisions physicians and patients must make, and including clinicians and informed patients in the design process would help.  Societies could help train clinicians to participate effectively in the CER process, and advocates could train patients, who are often concerned about outcomes—such as those related to quality of life—that may not be apparent to researchers or clinicians.

Specialty societies and patient advocates should help ensure that reports produced by the researchers undertaking CER studies are written to maximize their value for physicians and patients. 

Societies and patient advocates should review those reports and provide feedback to PCORI about their usefulness and suggested improvements.  Similarly, societies and advocates could seek out opportunities to review reports conducted outside of PCORI.

Specialty societies and patient advocates should support complete transparency in CER.  Societies and patient advocates should call for information about research methods, investigators’ affiliations, and funding sources to be detailed explicitly and disseminated with the findings.

Access/Dissemination

Specialty societies should incorporate CER findings as quickly as possible into practice guidelines, patient guides, and other educational and communication tools.  To maximize the usefulness of CER studies for clinicians and patients, specialty societies should respond quickly to new research, disseminating findings through their journals, continuing medical education (CME) offerings, and educational programs that meet the standards of specialty certifying boards for inclusion in maintenance of certification.  Patient advocates should also disseminate evidence-based research findings through their communication channels.

Specialty societies and patient advocates should advocate for decision support tools that incorporate guidelines reflecting CER findings.  Societies and patient advocates should work with the Office of the National Coordinator for Health Information Technology (ONC) and the HIT vendor and policy communities to ensure that systems and templates for electronic health records can accommodate the incorporation of guidelines reflecting CER findings, and can capture and deliver the data and information that are needed.

Physician-Patient Communication

Specialty societies should educate their members about how to talk to their patients about evidence-based medicine, emphasizing the importance of fully disclosing risks and benefits discovered in the research, and describing all viable treatment options.  Physician communication should also elicit patients’ concerns, preferences, and values.  Patient advocates should educate their constituents about the importance and validity of CER, describing how it can help advance more personalized care.  Doctors are uniquely positioned to persuade patients, most of whom have little experience as consumers or users of research or statistical evidence, of the value and integrity of CER findings.  However, many physicians could benefit from advice about how to talk about CER findings and their relevance to patients.  Specialty societies are well-suited to provide that assistance, and they should work collaboratively with patient advocates to develop communications strategies to reinforce the benefits of CER in improving care and address concerns that CER will lead to the denial of needed care.

Specialty societies and patient advocates should promote shared decision-making, including the use of decision aids that incorporate CER findings.  Societies and patient advocates can help promote the use of existing decision aids and  encourage the development of new ones.  Societies can also encourage physicians to welcome dialogue and empower their patients to become genuine partners in their care by encouraging discussion and questions about their care.

Measurement

Specialty societies and patient advocates should encourage measure developers to develop measures that are based on proven evidence.  As producers of guidelines that underlie measures, and as consumers of measures, specialty societies can enhance their quality both through basing guidelines on CER analyses and by urging the prompt development and updating of measures as the research base matures.  Patient advocates can promote patient experience measures and public reporting derived from measures reflecting evidence-based clinical guidelines.

As specialty societies build and expand registries, they should link CER and other evidence bases in order to optimally answer clinical questions.  Specialty societies are increasingly employing registries to identify and close gaps in quality of care, reduce wasteful and inefficient care variations, and implement quality improvement measures.  These registries’ power to shape care will be enhanced if they collect the categories of data that would be most useful to CER researchers.  Specialty societies and patient advocates should seek to support these linkages through future specifications for physician quality reporting system (PQRS) registries, meaningful use criteria, and electronic health record (EHR) certification standards.

Promoting CER

Specialty societies and patient advocates should encourage their constituents to communicate the benefits of CER within the medical and patient communities and among the public.  The practice of medicine and the health of the American people will be improved if CER can deliver on its promise, and physicians and engaged patients can be CER’s most effective ambassadors.  Physicians and patient leaders can publicly embrace CER and explain how it can improve health care quality and advance personalized care.

American Academy of Orthopaedic Surgeons Calls for Ethical Interactions with Industry

Relationships between physicians and medical device manufacturers are essential to the development of new technologies and innovative treatments.

However, a recent article from the American Academy of Orthopaedic Surgeons (AAOS) noted that physician-industry relationships have potential implications for fraud and abuse with programs in the Centers for Medicare and Medicaid Services (CMS).  The article noted that, “when engaging in relationships with manufacturers, physicians must be careful to avoid any arrangements that could be interpreted as violating antikickback or self-referral statutes.

The AAOS, AdvaMed (the association of medical device makers), and PhRMA (the association of drug manufacturers) have all established ethical codes to guide interactions between companies and healthcare professionals. These codes prohibit companies from using financial agreements and other gratuitous arrangements to encourage physicians to use their products.

AAOS noted that, “surgeons who are presented with the opportunity to work as paid consultants or promotional speakers should evaluate whether the compensation being offered for the service(s) is fair and at market value. An inflated figure could be seen as an attempt to induce physician loyalty and promote bias in the presentation.”

AAOS further explained that, “all consulting arrangements should be in writing and describe all services to be provided. Agreements covering clinical research services should include a written research protocol. Additionally, consulting arrangements should be based on a legitimate need for the services and consultants should be chosen on the basis of their qualifications and expertise.”

In addition, the article noted that, “arrangements with device companies that influence a physician’s decision to use a specific device based solely on financial incentives violate antikickback statutes.”  Such violates could lead to physicians incurring significant penalties, losing licensure, and even facing jail time.  Other arrangements that might be seen as violating antikickback statutes include

-       Preferred lease agreements with a hospital where the physician practices;

-       Research support;

-       Gifts, travel, or entertainment unrelated to the provision of services; and

-       Food or meals provided by an industry representative for the physician and office staff.

The article also explained that orthopaedic surgeons who initiate innovations or inventions, which may result in the payment of royalties by a manufacturer, should disclose their role in the device’s development to patients—as well as their receipt of royalties for its use to avoid the inference of impropriety.  It is important for patients to know that the use of a medical device is in the patient’s best interest and not tied to a surgeons financial interests.

Transparency and gift reporting

The AdvaMed Code of Ethics on Interactions with Health Care Professionals states that companies “may not give health care professionals any type of non-educational branded promotional items, even if the item is of minimal value and related to the health care professional’s work or for the benefit of patients.”

The article noted that under the Patient Protection and Affordable Care Act (PPACA), the Physician Payment Sunshine Act will require drug, device, and biologic companies to track all payments and transfers of value to U.S. healthcare providers made on or after Jan. 1, 2012. The law also requires companies to report any payment or transfer of value with a minimum value of $10/payment or $100/year (cumulative) to HHS and to publicly disclose the information on their websites, beginning in 2013.

AAOS also pointed out how some academic institutions have also chosen to regulate interactions between faculty members (or affiliated physicians) and industry.  Accordingly, the article recommend that, “physicians who are affiliated with such institutions should reference their institution’s policies before engaging in industry-sponsored research, applying for industry-sponsored educational or research grants, or serving as a consultant or director for a device company.”

The article also recommended that physicians should carefully note the distinctions between promotional sessions, which generally focus solely on a particular device brand, and education sessions such as continuing medical education (CME), which take a broader approach, assessing all available treatment options and devices for a specific condition.  “Physicians should also pay attention to the conflict of interest disclosures made by the presenters, as well as the degree of bias in the presentations.”

A compliance program

Finally, the article noted that under PPACA, physicians who treat Medicare and Medicaid beneficiaries must establish compliance programs. Although the law does not specify when this mandate will be implemented, AAOS recommended initiating a program now. According to the Office of the Inspector General (OIG), an adequate compliance program should include the following components:

• Internal monitoring and auditing
• Written compliance and practice standards
• A compliance officer or contact
• Appropriate training and education
• Appropriate response to offenses and timely corrective action
• Open lines of communication
• Enforcement of clear, well-publicized disciplinary standards

American Society of Plastic Surgeons Adopts Balanced Collaboration Policy

 
The American Society of Plastic Surgeons (ASPS) is the largest organization of board-certified plastic surgeons in the world.  Representing more than 7,000 physician members, the Society is recognized as a leading authority and information source on cosmetic and reconstructive plastic surgery.  ASPS comprises more than 94 percent of all board-certified plastic surgeons in the United States. 

Consequently, the ASPS recently adopted new guidelines designed to promote ethical interactions between its member physicians and the medical industry.   

The new guidelines, published in a document entitled, “Considerations for Interactions with Industry,” provide detailed recommendations for appropriate collaborations between individual plastic surgeons and pharmaceutical, biotechnology, or medical device companies in an effort to prevent industry support from biasing a physician’s professional activities or judgments. 

In announcing the new recommendations, ASPS President Phillip Haeck, MD, recognized that, “collaborations between physicians and industry are necessary as they enhance the practice of medicine.” Accordingly, Dr. Haeck noted that, “following these new guidelines will help to ensure that interactions with industry will be for the benefit of patients and remain consistent with AdvaMed and PhRMA Industry guidelines.” 

The document details standards related to the acceptance of gifts, educational products, meals and entertainment from industry; protocols for seeking industry support for educational programs; consulting arrangements; promotional speaking -- and the regulations associated with each. 

Dr. Haeck further noted that, “the new guidelines are voluntary and serve as a recommendation for behavior that ASPS members should adhere to.”  He asserted that, ASPS “members’ primary duty is to act in the best interest of patients and it’s vital they be independent and industry’s ability to influence professional judgements be limited.” 

ASPS Recommended Guidelines 

In the preamble of the guidelines, ASPS recognized that, “pharmaceutical, biotechnology, and medical device companies (“Industry”) develop, produce, market, or distribute drugs, devices, therapies, or services used to diagnose, treat, monitor, manage, and alleviate health conditions that allow individuals to live longer and healthier lives.”  Moreover, ASPS acknowledged that, “industry can help serve the interests of patients through beneficial collaborations with Members.” 

Additionally, the preamble recognizes that, “ethical relationships between ASPS members and industry are necessary to ensure public confidence in the objectivity of ASPS members which is critical for them to carry out their mission of serving patients.”  Accordingly, ASPS adopted the Considerations for Interactions with Industry to reinforce the core principles that help ASPS maintain actual and perceived independence, and ensure ethical relationships between our members and industry. 

Basis of Interactions with Industry 

ASPS asserted that interactions and relationships with industry are already regulated by multiple entities and are intended to benefit patients and to enhance the practice of medicine. Accordingly, they noted that such interactions should be focused on receiving information about products, technologies and services that allow us to serve the best interests of ASPS Members’ patients. 

Receiving Items of Value from Industry 

The guidelines state that ASPS members should not accept the following from Industry: 

• Items that do not advance treatment education, including pens, note pads, mugs, and similar “reminder” items with company or product logos.
• Items intended for the personal benefit of healthcare professionals (such as floral arrangements, artwork, music CDs, or tickets to a sporting event) Payments in cash or cash equivalents (such as gift certificates) should not be accepted either directly or indirectly, except as compensation for bona fide services.  

It is appropriate to receive a reasonable quantity of product samples for patient use for purposes of product education, evaluation, and demonstration. 

Receiving Educational Items from Industry 

ASPS members, where permitted by law, may accept from Industry items designed primarily for the education of patients or healthcare professionals if the items are not of substantial value ($100 or less) and do not have value to Members outside of his or her professional responsibilities. For example, an anatomical model for use in an examination room is intended for the education of the patients and is appropriate.  Items designed primarily for the education of patients or healthcare professionals should not be accepted by Members on more than an occasional basis. 

Entertainment and Recreation 

ASPS Members should not accept, any entertainment or recreational items, such as tickets to the theater or sporting events, sporting equipment, or leisure or

vacation trips. Such entertainment or recreational benefits should not be accepted, regardless of (1) the value of the items, (2) whether Industry engages the healthcare professional as a speaker or consultant, or (3) whether the entertainment or recreation is secondary to an educational purpose. 

Informational Discussions and Meals with Industry 

The guidelines recognize that “informational discussions with Industry representatives and others speaking on behalf of a company provide ASPS Members with valuable scientific and clinical information about products, technologies, treatments, and services that may lead to improved patient care. 

Accordingly, the guidelines state that In order to facilitate these “important scientific and medical discussions, while respecting Members’ abilities to manage their schedules and provide patient care, Industry representatives may take the opportunity to present information at mealtimes. 

Additionally, ASPS noted that, “in connection with such presentations or discussions, it is appropriate for occasional meals to be offered by Industry as a business courtesy to Members as well as members of their staff attending presentations, so long as the presentations provide scientific or educational value and the meals

• Are modest
• Are not part of an entertainment or recreational event, and
• Are provided in a manner conducive to informational communication.

ASPS members cannot bring a spouse or other guest in a meal accompanying an

informational presentation made by or on behalf of an Industry representative is not appropriate.  In addition, accepting “take-out” meals or meals to be eaten without an Industry representative being present (such as “dine & dash” programs) is not appropriate.

Continuing Medical Education

The ASPS recommendations acknowledge that continuing medical education (CME) “helps physicians and other medical professionals to obtain information and insights that can contribute to the improvement of patient care, and therefore, financial support from Industry is appropriate. Such financial support for CME is intended to support education on a full range of treatment options and not to promote a particular product.”

Accordingly, ASPS recommends that any financial support from Industry should be given to the CME provider (ASPS), which, in turn, can use the money to reduce the overall CME registration fee for all participants. ASPS noted that, “industry should respect the independent judgment of the ASPS as the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME activity.”

In addition, this guideline recognizes that, “when companies underwrite CME, responsibility for and control over the selection of content, faculty, educational methods, materials, and venue belongs to the CME provider in accordance with their guidelines.” As a result, ASPS noted that,  “industry should not be asked to provide any advice or guidance to the CME provider or Members involved in the CME program regarding the content or faculty for a particular CME program funded by Industry.”

Additionally, ASPS recommends that Members should not accept direct financial support from Industry for the costs of travel, lodging, or other personal expenses related to attending CME programs. Similarly, funding should not be accepted by Members to compensate for the time spent by Members attending the CME program.

It is appropriate for Members serving as faculty at ASPS educational programs to receive honorarium and financial support for travel, lodging, and related expenses from ASPS (as the CME Provider) in accordance with its written policies governing faculty reimbursement. Members serving as ASPS faculty should not accept additional financial support directly from Industry for their role as faculty

Industry Support for ASPS Meetings

The guidelines also recognized that educational conferences or professional meetings of ASPS or its Members can contribute to the improvement of patient care, and therefore, financial support from Industry is appropriate. A conference or meeting is any activity, held at an appropriate location, where:

•  The gathering is primarily dedicated, in both time and effort, to promoting objective scientific and educational activities and discourse (one or more educational presentation(s) should be the highlight of the gathering); and
• The main incentive for bringing attendees together is to further their knowledge on the topic(s) being presented.

Similar to CME, any financial support should be given to the conference’s sponsor (ASPS), which, in turn, can use the money to reduce the overall conference registration fee for all attendees.

Financial support should not be accepted by Members for the costs of travel, lodging, or other personal expenses of Members attending third-party scientific or educational conferences or professional meetings. Similarly, funding should not be accepted by Members to compensate for the time spent attending the conference or meeting.

Serving as a Consultant for Industry

The ASPS guidelines recognize that “consulting arrangements with Industry allow companies to obtain information or advice from medical experts on such topics as the marketplace, products, therapeutic areas, and the needs of patients. Industry uses this advice to inform their efforts to ensure that the products they produce and market are meeting the needs of patients.”

Accordingly, the guidelines assert that it is appropriate for Members who provide advisory services to be offered reasonable compensation based on fair market value for those services and reimbursement for reasonable travel, lodging, and meal expenses incurred as part of providing those services.

However, ASPS Members should not participate in recreational or entertainment events in conjunction with these meetings and it is not appropriate to accept honoraria or travel or lodging expenses for spouses or guests of Members attending Industry-sponsored consultant meetings.  Modest meals or receptions may be appropriate during Industry-sponsored meetings with healthcare professional consultants, but token consulting or advisory arrangements should not be used to justify compensating Members for their time or their travel, lodging, and other out-of-pocket expenses.

Serving as a Promotional Speaker for Industry

ASPS guidelines also recognize that members participate in Industry-sponsored speaker programs “in order to help educate and inform other healthcare professionals about the benefits, risks, and appropriate uses of Industry products.”  The guidelines note that Member engaged by a company to participate in such external promotional programs should be selected based on their medical expertise and reputation, knowledge and experience regarding a particular therapeutic area, and communications skills. Industry and Members should not enter speaking arrangements as inducements or rewards for prescribing or using a particular medicine or product.

 Speaker training is an essential activity because the FDA holds speakers accountable for presentations made on behalf of Industry. It is appropriate for Members who participate in programs intended to train speakers for Industry-sponsored speaker programs to be offered reasonable compensation for their time, considering the value of the type of services provided, and to be offered reimbursement for reasonable travel, lodging, and meal expenses. Such compensation and reimbursement should only be accepted by Members when

 The participants receive extensive training on the company’s drug products or other specific topic to be presented and on compliance with FDA regulatory requirements for communications (including prohibition of promoting “off label”)

• This training will result in the participants providing a valuable service to the company; and
• The participants meet the general criteria for bona fide consulting arrangements.

Any compensation or reimbursement for a speaking arrangement should be reasonable and based on fair market value. Speaker programs may include modest meals offered to attendees and should occur in a venue and manner conducive to informational communication. ASPS also recognized that speaker programs are distinct from CME programs, and speakers and their materials should clearly identify the company that is sponsoring the presentation, the fact that the speaker is presenting on behalf of the company, and that the speaker is presenting information that is consistent with FDA guidelines.

American Medical Student Association and Their Pharm Free Association with Naturopathy

 
Recently, the American Medical Students Association (AMSA) held their annual conference.  Interestingly, one of the participants of the conference provided an ongoing commentary of the events and happenings at this year’s conference.

 

Of particular interest, the commentator noted that AMSA sold the Association of Accredited Naturopathic Medical Colleges a booth at the 2011 convention.  As the author pointed out, AMSA will not take money from pharmaceutical companies, but they have no problem with taking money from “pseudoscience.”  Perhaps a conflict of interest?

 

Consequently, the author described how he went up to the booth to find out what

naturopathy is.  He was told that they are “primary care physicians” who treat the “whole patient in a holistic way.” In addition, one of the table reps told the author that naturopathy subscribes to the use of homeopathy, herbalism, acupuncture, therapeutic touch, and “all sorts of other nonsense.”  The author also pointed out that their “written materials were more straightforward about their quackishness.”  Ultimately, while AMSA “professes to support evidence-based medicine,” the author was disturbed by the fact that AMSA  would legitimize “quackery of this sort.”

 

What is problematic about AMSA’s approach of accepting alternative medicine and banning pharmaceutical support is that it creates an inherent bias among the organization.  This bias is detrimental to advancing medicine, science, and medical education, particularly because AMSA is a vocal voice in the medical community.  Such a revelation that AMSA is willing to accept money from “pseudoscience” instead of hard science, should cast many doubts on the positions that the organization maintains on various policies.  Calling for evidence-based practices, while accepting money from alternative medicine—hardly even close to evidence based—should also cast serious concerns about the Soros and Pew funded PharmFree Campaign started by AMSA in 2002.

PharmFree Campaign

The campaign was started for medical students to advocate for evidence-based, rather than marketing-based prescribing practices, the removal of conflicts of interest and global access to essential medicines. AMSA provides toolkits, talks and training institutes to help medical students advance these goals.

To advance these goals, AMSA released its first "PharmFree Scorecard" in 2007. This initial Scorecard graded medical schools on the presence or absence of a policy regulating the interactions between their students and faculty and the pharmaceutical and device industries. In 2008, AMSA worked with The Pew Prescription Project, an initiative of the Pew Health Group, to develop an updated Scorecard, which used a rigorous and transparent methodology to assess the content of policies at medical schools throughout the country. 

This framework was used again in the 2010 AMSA PharmFree Scorecard, published last month. The AMSA PharmFree Scorecard evaluated conflict-of-interest policies at 152 medical colleges and colleges of osteopathic medicine in the United States, with a focus on interaction between students or faculty and the pharmaceutical industry.

Using letter grades to assess schools’ performance in eleven potential areas of conflict, the Scorecard gives a comprehensive look at the current and changing landscape of conflict-of-interest policies across American medical education, as well as more in-depth assessment of individual policies that govern industry interaction. It also examined potential conflicts of interest created by industry marketing at the level of the individual physician and trainee. 

Method 

The PharmFree Scorecard methodology was developed jointly by AMSA and the Pew Prescription Project, an initiative of the Pew Health Group. Assessed domains are broadly consistent with those identified in recent literature – primarily Brennan et al. Health Industry Practices that Create Conflicts of Interest:  A Policy Proposal for Academic Medical Centers. These include policies related to acceptance of gifts and meals from industry; consulting relationships; speaking relationships; disclosure of financial conflicts; and pharmaceutical samples.

Two blinded assessors independently score each set of policies in the eleven areas included in the scorecard, and then use a formula to derive a letter grade.   

2010 AMSA Scorecard

As of December 15, 2010, 140 of 152 medical institutions had participated in the Scorecard, a 92% participation rate, improved from 88% in 2009. Of 152 US medical schools:

-       19 receive As (13%)

-       60 Bs (39%)

-       24 Cs (16%)

-       18 Ds (12%), and 

-       26 schools (17%) receive a grade of F.

In 2010, over 50% of medical schools, now have grades of A or B (78 schools). This was a tremendous increase from 45 A and B schools (30%) in 2009 and shows a continued progression from 29 A and B schools in 2008. Additionally, 21 schools improved their scores to a C or above after submitting updated policies for review.

AMSA noted in response to this data that “Conflict of interest has clearly become a central issue in medical administration and education and more schools are recognizing the importance of thorough policies.” Specifically, AMSA recognized the University of South Dakota Sanford School of Medicine, Tufts University, and Des Moines College of Osteopathic Medicine for “submitting dramatically improved policies which increased their scores from Ds to As.”

The 2010 Scorecards also recognized 9 other schools that improved at least 2 letter grades: Wake Forest University, New York Medical College, Virginia Commonwealth University, University of Minnesota-Twin Cities, Temple University, Case Western Reserve University, University of Illinois, and University of New England College of Osteopathic Medicine.

The report also noted that medical schools in California, Pennsylvania, New York, Texas, Florida and Massachusetts continued to excel, with a majority of medical schools in each state earning strong grades on the Scorecard. In addition, between 2008 and 2010, the number of perfect scores increased in every domain graded by the Scorecard. 

For example, in 2010, three times as many schools received perfect scores for addressing industry support of scholarships, off-campus continuing medical education, purchasing, and gifts compared to 2008. Notably, the number of institutions with model curriculum on conflict of interest quadrupled between 2008 and 2010.

Nearly one-third of schools now teach medical students to understand institutional conflict of interest policies, to recognize how industry promotion and marketing can influence clinical judgment, and to consider the ethics around conflict of interest. The areas with fewest perfect scores were on-campus continuing medical education (CME) and the access of sales representatives.

Discussion

AMSA's national president, Dr. Brian Hurley, noted that “AMSA's Scorecard is meant to be not only a yardstick for measuring U.S. medical school conflict-of-interest policies, but also a guide for medical schools working toward adopting stronger and more practical policies.”

Robert Restuccia, executive director of The Prescription Project asserted that "The schools that earned 'A' and 'B' scores are to be commended for setting a high bar and aggressively moving forward to ensure medical education, training and patient care is free of commercial bias.”

Heather Pierce, JD, senior director of science policy and regulatory counsel at the Association of American Medical Colleges (AAMC) asserted that “The positive changes reflected in this assessment highlight the active engagement of the academic medical community in addressing industry interactions, both through policies and the education of its faculty and students.”

However, the Association of Clinical Researchers and Educators (ACRE), which supports relationships with drug companies, called AMSA misguided for its lack of understanding about how such partnerships can benefit students and patients. ACRE noted in its statement that “AMSA has devoted their time and resources rating medical schools on biased, meaningless subjects which reflect little on their actual education."

Additionally, one physician stated that he was proud that the academic medical center he worked at, Western University, received an F from AMSA Scorecard. Specifically, Jeff Unger, MD, associate director of metabolic studies at Catalina Research Institute in Chino, asserted that the AMSA Scorecard and Pew Prescription Project are an “obscure group of liberals who have nothing better to do than criticize those of us in the private sector trying to improve the lives of our patients.”

Dr. Unger’s editorial offered AMSA and Pew a historical lesson about the pharmaceutical industry in hopes that they might spend their time on something better than “releasing results of such useless surveys.” He pointed out how the discovery of insulin in 1922, which was mass-produced by pharmaceutical companies such as Eli Lilly, changed the landscape of medical science and proved that chronic disease could be treated effectively with a specific medication. Since 1945, the pharmaceutical companies have spent billions of dollars developing new classes of drugs to treat diabetes.

As a result, he asserted that “None of these accomplishments would be possible without pharmaceutical company innovation, education and support.” Morever, Dr. Unger recognized that “pharmaceutical companies are not the enemy, and that all increasing government interference with companies has done is drive up research and development costs.

Dr. Unger further acknowledged that the role of industry is important because pharmaceutical companies “provide educational opportunities to physicians, physician assistants, nurses, nurse practitioners and certified diabetic educators about disease state awareness and treatment guidelines.” As he noted, “these programs are tightly regulated by the FDA and providers who attend these programs overwhelmingly approve of the educational format and the professionalism of the presentations.” 

With respect to other policies graded by the scorecard, Dr. Unger explained that “Patients should thank physicians who see pharma reps because they enable physicians to provide patients free samples for medications they are unable to afford because their insurance will not cover them. These samples are extremely important for diabetes patients because the medications used to manage diabetes “are often safer and more effective than those available on standard third-payer formularies.”

He also pointed out that with the assistance of pharmaceutical representatives, physicians can help patients in applying for company programs that help patients pay for drugs they cannot afford.

One important observation about the important role of industry that Dr. Unger offered was a recent experience he had while lecturing. He explained that the speakers “before him, who were from Ivy League schools that did not allow visits from pharmaceutical reps, gave the audience incorrect information regarding a particular diabetes drug.” As a result, he had to “correct the audience by explaining the latest FDA approvals regarding the particular drug, which a pharmaceutical representative had explained to him three days prior to this national meeting.” 

Conclusion

Ultimately, the impact of the AMSA Scorecard remains questionable, especially given the new revelation that AMSA accepts money from alternative medicine, but not industry. Where does the actual quality of teaching or patient care get ranked in their system? Does ‘improved’ score equate to anything other than less media attention of non-issue? While it is important that academic medical centers continue to implement policies for interacting with industry, until evidence shows that less industry-academia collaboration improves patient care and outcomes, these Scorecards will continue to hinder collaboration and innovation, and AMSA and the Pews will continue to be “thorns in the side of medical progress.”

As Dr. Unger recognized, academic medical centers “should continue to welcome pharmaceutical reps and pharma companies onto the campus and their medical students should learn the value that these liaisons share in changing the lives of individuals afflicted with acute and chronic diseases.” Moving forward, Dr. Unger noted that instead of listening to AMSA and Pew, “the voices of patients who suffer from chronic diseases are the only ones that should count in the finally tally.” 

American Rhinologic Society Rational Approach to Relationships with Industry

 
To encourage innovation and advances in patient care while ensuring integrity, the American Rhinologic Society (ARS) recently adopted a conflict of interest policy that permits transparent interactions between medical companies and ARS and its leadership.

The American Rhinologic Society is the world's largest physician organization whose mission focuses upon the medical and surgical treatment of patients with diseases of the nose and paranasal sinuses. Patient care, research, and education are integral to the ARS mission.

In a press release last week, the ARS noted its decision to not adopt the Council of Medical Specialty Society’s (CMSS) Code for Interaction with Companies because company funding and relationships are not allowed under the code.

ARS leaders “believe such an extreme policy would be harmful to patients.” While there have been “some well-publicized incidents of doctors and companies who have abused the system,” Brent Senior M.D., ARS president and chief of Rhinology, Allergy and Sinus Surgery at the University of North Carolina at Chapel Hill, noted that it would be “a mistake to forbid any interaction with companies” because of these few incidents.

Specifically, Dr. Senior recognized that these “relationships are crucial to innovation and advancements in patient care, and if those lines of communication and opportunities for funding are shut down, patients will suffer.” 

The press release also discussed how “ARS leaders recognize that medical innovations require money and resources and, conversely, that companies must rely on doctors who work with patients on a daily basis to determine what issues need solving as well as products, services and drugs that should be developed.”

Moreover, ARS acknowledged that, “government and not-for-profit research money is limited and many studies are funded by companies.” 

For example, ARS noted that, “an HIV/AIDS diagnosis is no longer the death sentence it once was, thanks to research performed by physicians who treat patients with the disease and funded by pharmaceutical companies developing drugs that help people manage the disease.”

In addition to treatments, Dr. Senior noted that, “nearly any new surgical procedure or device is by necessity developed through a partnership with physicians and companies.” “Further, medical specialty societies are headed by thought leaders, who are best able to interact with industry in a positive way to help patients.”

ARS Conflict of Interest Policy

Accordingly, “the ARS policy seeks to take a rational approach to relationships with companies. The policy does not set dollar amounts or limit interaction between companies and ARS leaders, or members of its organizational committees, task forces and panels, but it does insist on 100 percent transparency and lists those relationships and specifics on its website.”

The policy also creates ground rules for these relationships to prevent company influence. For instance, a “doctor must disclose a conflict of interest and may sit on a panel and participate in the debate, but not in the drafting of policy or voting.”

Dr. Senior recognized that the “policy of transparency respects the intelligence of patients and doctors by allowing them to make their own decisions based on the nature of the relationship.”

For example, Dr. Senior noted that, “if a patient knows that Dr. Jones received $250,000 from a company, he might understandably have concerns about the doctor and choose to see someone else, but if he knows the doctor was treated to a $45 dinner while he learned about a new innovation, it’s less likely to be a major concern.”

The policy defines conflict of interest as “a condition which occurs when an individual or organization has an interest that might compromise their actions. The presence of a conflict of interest is independent from the execution of impropriety.” The policy also requires the setting up an Ethics or Conflict of Interest Committee

Under the “Transparency” section, the policy specifically defines conflict of interest is defined as “receipt of remuneration, goods, or services in excess of $500. The ARS will publicly disclose Company support (at a minimum Educational Grants, Sponsorships, and Charitable Donations) exceeding $1000. And, the ARS will disclose relationships that Society Officers and members of the Board of Directors have with Companies exceeding $500. 

With respect to continuing medical education (CME), the policy establishes that ARS will comply with ACCME Standards for Commercial Support and that the ARS will retain control over the use of Educational Grants, and implement safeguards designed to ensure that educational programs are non-promotional and free from commercial influence and bias. 

The ARS will limit support opportunities to general topics (i.e., not product-specific) and will make efforts to achieve a balanced portfolio of support for each CME program. The ARS will not permit Key Society Leaders to participate in Satellite Symposia. In addition, the policy also covers a number of other areas including advertising, exhibits, journals, clinical care, and research.

Discussion

The ARS new policy on conflicts of interest is extremely well balanced in preserving innovation and collaboration in medicine, while also ensuring the proper balance of transparency and integrity in maintaining physician-industry relationships.

As the ARS correctly acknowledges in the beginning of their policy, “for-profit entities that develop, produce, or market drugs, devices, services or therapies used to diagnose, treat, monitor, manage, and alleviate health conditions, also strive to help patients live longer and healthier lives.” Moreover, “companies invest resources to bring new drugs, devices and therapies out of the laboratory and to the patient while maximizing value for shareholders.” 

Because numerous medical organizations recognize the same principles and values of physician-industry collaboration that ARS does, other medical societies and professional organizations should reference ARS’s new policy for guidance on how to establish such a well-balanced policy for conflicts of interest. As ARS has done with its new policy, professional associations and societies must place the emphasis on ways to promote, encourage, and protect innovation through proper safeguards, instead of prohibiting such relationships.

CMSS Submits Comments to HHS-CMS on Sunshine Provisions

 

The Council of Medical Specialty Societies (CMSS), whose 37 member organizations represent 700,000 physicians in the US, recently submitted comments to the Centers for Medicare and Medicaid (CMS) on proposed rule-making for the Physician Payments Sunshine Act (PPSA) or Section 6002 of the Affordable Care Act (ACA).

The comments first noted that CMSS operates under two strategic priorities, both of which enable the organization to support the PPSA:

• CMSS and its member organizations facilitate a Culture of Performance Improvement in medical practice
• CMSS and its member organizations model Professionalism, as measured by Altruism (putting the needs of patients first), Self‐regulation, and Transparency.

In addition, CMSS recently adopted the CMSS Code for Interactions with Companies, providing guidance to medical specialty societies, representing most physicians in the US, in their relationships with industry.  The CMSS Code was “adopted to reinforce core principles which guide specialty societies in maintaining actual and perceived independence. The CMSS Code helps to ensure that a specialty society’s interactions with industry will be for the benefit of patients and for the improvement of medical care.”

Consequently, CMSS noted the importance of Congress not including indirect relationships (such as grants to providers of certified continuing medical education [CME]) in the act because such payments do not involve direct financial relationships between physicians and companies.

Forms and Nature of Payment and Transfer of Value

CMSS agreed that direct payments and transfers of value from companies that should be disclosed include cash, stock, stock options, ownership interests, dividends, consulting fees, gifts, entertainment, food, travel, research support, royalties, license fees and other direct compensation.  However, they noted that it was “unclear what Congress intended as it relates to “honoraria,” which could include a payment that is made as direct compensation to a physician from a company; but this is a term which is not often used in this context.

Their comments also noted that the term “education” is not usually used to reflect a direct financial relationship between a physician and a company.  Accordingly, CMSS recognized that “education in the sense of certified continuing medical education (CME) is governed by the Standards for Commercial Support: Standards to Ensure the Independence of CME (SCS), promulgated by the Accreditation Council for Continuing Medical Education (ACCME), to which the entire profession of medicine adheres. The SCS (most recently revised in 2004) set standards for relationships between providers of certified CME and the companies which provide grants to the providers to support CME.”

As a result, CMSS asserted that, “in the context of certified CME, direct payments to physicians (either in the role of faculty or attendees) by companies are prohibited, cannot occur, and therefore would be irrelevant when it comes to disclosure under the PPSA.”

CMSS also recognized that the AMA Code of Medical Ethics (specifically the Ethical Opinions on Gifts to Physicians from Industry, and Ethical Issues in CME) address individual physician responsibilities as well as provide guidance for providers offering continuing medical education activities.

Therefore, they acknowledged that under the PPSA, only direct payments to physicians for serving as speakers at company sponsored promotional educational programs would be covered, which are distinct from certified CME programs, and which are instead overseen by the Food and Drug Administration (FDA).

Additional Information for Consumers – Context:

Next, CMSS recommended that the context of direct financial relationships between physicians and companies be described when disclosed to the public.  Specifically, they noted that the public will not likely understand the nature of many disclosed relationships, not all of which are equivalent.  For example, there is a wide array of “consulting” that a physician could do with industry.  Accordingly, CMSS asserted that the information disclosed to patients contain a description of the context of the relationship.

Reporting of Data – Consistency:

CMSS recommended that a standardized set of information be collected on the relationships between physicians and companies, for purposes of reporting through the PPSA.  They urged CMS to require a standardized set of data to be collected and reported by companies because a standard set of expectations promulgated by CMS can decrease the burden and “hassle factor” on physicians.  Therefore, standardized categories and data elements must be established in the regulations by CMS as an expectation of reporting by companies.

Moreover, CMSS asserted that standardized expectations of how collected information will be used should be communicated in the regulations to enhance the trust of physicians whose individual professional relationships are to be disclosed.  CMSS noted that, “limiting the use of collected information to standardized disclosure of covered relationships, the intent of the PPSA, is critical.”  Otherwise, additional use of collected information by companies (i.e. for marketing purposes) or by CMS (i.e. to determine compensation levels) “will destroy the trust of physicians, and would not serve the interests of the public for which the PPSA was created.”

Finally, CMSS recommended that a mechanism be established whereby physicians may contact the reporting body through an appeals process to correct erroneous information, which has been disclosed.

Conclusion

Ultimately, CMSS noted that CMS “should attend to clarifying the direct financial relationships between physicians and industry for purposes of reporting, requiring companies to describe the context of relationships so that consumers understand them, and requiring companies to consistently collect and report data in a standardized and uniform fashion.”

They noted that, “following these “three C’s” will meet the intent of the PPSA without adding to the burden of the system, detracting from the ability of physicians to enhance the quality of care they provide to patients.”

New York Times: The Un-Ghost Writing of the Distant Past

 

When one thinks of ghost writing, they may conjure up thoughts of secret writers and scheming in the background with some nefarious plan in mind. Or an attorney who has his team preparing his important last minute brief, never giving thought of assigning credit to any of the contributors.  That is why it was so unusual for the New York Times to run a story alleging that drug companies had essentially paid two authors eleven years ago to put their names on a medical handbook, written by unacknowledged authors.   The problem with the story is everything was acknowledged in the preface of the handbook.

The book, entitled “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” published in 1999 , listed two distinguished authors—Charles Nemeroff, who chairs the psychiatry department at the University of Miami medical school, and Alan Schatzberg, who was chair of the psychiatry department at the Stanford University School of Medicine from 1991 until recently.  

The preface of the book acknowledges an “unrestricted educational grant” from SmithKline Beechman (now GlaxoSmithKline). It also acknowledges Scientific Therapeutics Information (STI) and Diane M. Coniglio for "editorial assistance."

After reviewing unsealed materials  the Times received from the Los Angeles law firm of Baum Hedlund as part of discovery in lawsuits against GlaxoSmithKline, involving Paxil, the article asserted that the books preface insufficiently acknowledged the role of GSK and STI.   The article however does not mention that this lawsuit was filed by a whistleblower under the qui tam provision, and that both the law firm and whistleblower stand to benefit significantly by any evidence of wrongdoing by the company. What were the financial motivations of the lawyers sending this information to the Times?

Despite failing to mention this important detail, the Times asserts that “SmithKline Beecham, actually had much more involvement than the book described.” Specifically, they allege that the documents show that “the grant paid for a writing company to develop the outline and text for the two named authors, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”

Leemon B. McHenry, a bioethicist with California State University, Northridge, who is a hired consultant for the plaintiff’s law firm, told the Times that many similar documents remain sealed, and claimed that this was “only the tip of the iceberg.”

Kevin G. Colgan, a spokesman for GlaxoSmithKline, disagreed. He insisted that the company’s role in producing the book was described accurately in its preface.

The “book has never been in wide circulation and has not been sold for a few years.” It sold about 26,000 copies, including 10,000 bought by SmithKline Beecham for American family doctors and 10,000 purchased by the Dutch pharmaceutical company Organon. The authors together received a 15 percent royalty on sales of $120,000 sales, or about $18,000. Estimating the time it takes to write a 200 plus page book, the authors roughly made $15 per hour, not exactly what pay one expects from a story writing as if the doctors are living “Lifestyles of the Rich and Famous”.   This figure does not take into account the time spent by the eight independent reviewers.

Consequently, disclosure standards have changed in the 12 years since the book was published. The Times article doesn’t emphasize this sufficiently. Today, industry funding for medical writing and research is much more restricted. PhRMA itself issued its first Code of Ethics in 2002. It was widely praised at the time. The Code was extensively revised and made more restrictive in 2008.

The claims that the Times advance are misguided and skeptical. The handbook was published by two highly respected, albeit somewhat controversial psychiatric authorities over a decade ago, ancient news.  In 2008, Emory University imposed a two-year ban on Dr. Nemeroff receiving NIH grants after a Senate inquiry found that he had failed to disclose at least $1.2 million in industry financing over seven years from pharmaceutical companies, including GlaxoSmithKline.   Dr. Schatzberg was accused of similar disclosure of payments issues by Senator Grassley but was subsequently exonerated.  Senator Grassley also inquired with Stanford about ghost writing but no evidence was ever found.  Former Grassley staffer Paul Thacker who is the source of this NY Times article was fully aware of that fact.

Since no one has set forth any claims other than improper attribution of funding and editorial assistance, presumably then, the effort to produce this handbook led to a good quality project and everybody wins. The psychiatrists assure the quality, and they enhance their visibility and reputations. The writers improve clarity. The readers get good information.  To the same extent that if some products discussed in the book along with competitive products and were sold by Smith Kline Beecham, the company benefits. If there is no inappropriate promotion of Smith Kline Beecham products, nobody gets hurt.

The "story" doesn't contain a shred of evidence to contradict that possibility. Instead, this story represents another synergy between activists like Paul Thacker and journalists who fail to objectively investigate the whole issue, or fairly report such information.  What sells papers is in the “best interest” of journalists, and advancing activists' agenda to discredit industry and please their ideologically like-minded sponsors and their legal clients appears to be the only interest news sources are considering these days on this issue.

The article does a poor job trying to maintain neutrality and violates many journalistic principles. It only quotes liberals and industry critics, none of which are “experts” in publishing or psychiatry.   What authorizes them to weigh in—other than to throw around one of the most muddled epithet slogans—on "ghostwriting?" The answer is that lawyers just want to use these insinuations to influence juries.

But did any of the critics actually read the book? Criticizing literary involvement of industry sponsors is a better idea once one has established that the finished work is in some way incomplete, inaccurate, or unlawful (i.e. off-label promotion). From the “experts” identified in the Times article it appears that no such claims are advanced and no one has read or even used the book. Had this been responsible, objective reporting, the author would have sought commentary from relevant experts in the field to determine first whether the book makes erroneous or hazardous recommendations, especially related to drug dosing.

For all we know, the book could have saved thousands of lives.

American Psychiatric Association

In response to the Times story, the American Psychiatric Association (APA) issued a press release asserting that the handbook was “reviewed for bias by eight physicians and not ghostwritten by a pharmaceutical company,” and appropriately identified editorial assistance from STI and funding of through an unrestricted grant from GSK. APA asserted that “the pharmaceutical company had no rights to approval on the editorial content, nor would any of us have granted them that authority.”

Project on Government Oversight

The Times story also arose because the Project on Government Oversight (POGO) sent a letter to the National Institutes of Health (NIH) Director Dr. Francis Collins asserting that NIH needs to make regulations to prohibit ghostwriting. The letter, a product of the investigative work of Paul Thacker, former staffer of Senator Charles Grassley (R-IA), essentially alleges that ghostwriting is a prevalent practice, and that researchers receiving federal funding through NIH grants that participate in ghostwriting or have in the past, should be banned from federal health research funding.

Background

According to Dr. Schatzberg, the materials in question were not a textbook, rather it was a handbook or primer for primary care physicians. In response to the allegations that this was a “ghostwritten” book, Dr. Nemeroff and Dr. Schatzberg responded to questions by e-mail last week and emphasized the “unrestricted” nature of the grant from the drug maker to develop the book and said they did most of the work.

Dr. Schatzberg firmly maintained that SmithKlineBeecham “had no involvement in content,” and that “An unrestricted grant does not give the company any right of sign-off on content and in fact they had no sign-off in content.” Dr. Nemeroff said he and Dr. Schatzberg “conceptualized this book, wrote the original outline and worked on all of the content.”

Despite their assertions, the issue raised by POGO and the Times stems from a letter dated Feb. 4, 1997, documenting the relationship between Dr. Nemeroff, GSK and STI. A review of this letter indicated that STI had developed “a complete content outline” for Dr. Nemeroff’s comment and had “begun development of the text.” The outline is pretty bare bones, and uncontroversial.

Although Dr. Schatzberg had not seen the 1997 letter to Dr. Nemeroff, he asserted that it was merely “a theoretical proposal that bears little, if any relationship to what actually happened.” Dr. Nemeroff further maintained that he and Dr. Schatzberg “scrutinized every page and rewrote and edited as we deemed necessary,” keeping control of the final draft.

In its press release, APA clarified that the “letter showed a timeline for development of the book by the editorial service but did not show that the book was “ghostwritten” by the company.” From APA’s perspective, they recognized that the “timeline and details in the letter were never approved by APPI or the authors, and a contract between the authors and APPI was not executed until 2 years after the letter.” As Dr. Schatzberg explained, the letter mentions a delivery of the book by August 1997. However, this was not the final arrangement. He noted that they did not negotiate a contract with APPI until 1998 and that was signed in 1999, around the time when the book was actually completed. Accordingly, Dr. Schatzberg asserted that “there is little relationship of the 1997 letter to the reality of what occurred.” 

“This type of editorial assistance was quite common, especially the use of editorial experts to compile and check facts in books on pharmacology,” said Ron McMillen, chief executive of American Psychiatric Publishing. “To say the book was ghostwritten is not true. Our contracts hold the authors responsible for the content.”

McMillen added, “Every book APPI publishes is peer-reviewed by medical doctors. In this case, the APPI editors got five separate reviews and the American Medical Association, which co-published the book, got three more. All of them were favorable,” McMillen said. The use of APPI should come as no surprise, especially given that Dr. Schatzberg has published over 15 books with APPI, and the publisher had knowledge from the start that GSK was providing support and STI was providing editorial assistance.

But the Times tries to discount this information by quoting Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest. After reviewing the documents, Dr. Lo an expert on all things concerning (no need for facts) ethics asserted that the grant did not sound “unrestricted,” and that it appeared as though the company had “ultimate control.” Consequently, the Times maintains that this is the first “book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.”

Discussion

McMillen reviewed files on the book this week and found no evidence of influence by the writing company or GlaxoSmithKline. However, he told the Times that he was unaware of the plan outlined in the two-page letter to Dr. Nemeroff, and that this would have “showed more involvement than we would accept.”

Nevertheless, McMillen was quoted in the APA news release asserting that the kind of editorial assistance the handbook got was “quite common, especially the use of editorial experts to compile and check facts in books on pharmacology.” He further asserted that, “To say the book was ghostwritten is not true. Our contracts hold the authors responsible for the content.”

The letter published by The Times indicated the “sponsor” would review drafts throughout the process, but the publisher’s records show no signs of influence from the company, McMillen said. In fact, there were more than 500 suggested corrections on the part of reviewers and all revisions were made to the manuscript that APPI published.

One important detail that was left out of the Times article and POGO letter was some background for the book. Dr. Schatzberg noted that he and Dr. Nemeroff came up with the idea for the handbook after publishing an actual psychopharmacology textbook for psychiatrists. Their idea came long before there was any pharmaceutical interest in distributing it. Dr. Nemeroff said the book was written to fill an unmet need in educating family doctors and primary care physicians on how to provide adequate treatment for people with mental illness. He added that the book “remains quite accurate and relevant to clinical practice today.”

When the authors decided to move forward with the idea of a primer and received funding, STI provided some editorial and outline assistance and specific contributors from STI were duly and appropriately noted. Dr. Schatzberg further asserted that given the standards in 1999, the disclosures for the handbook were appropriate then, and would still be today. Accordingly, he emphasized that any implication that he or Dr. Nemeroff did not write the handbook is not accurate.

These assertions however were discounted by Dr. David A. Kessler, former commissioner of the Food and Drug Administration, who reviewed the documents, and believed that the entire handbook was essentially ghostwritten.

Conclusion

Changes in journals, professional societies, and academic medical centers to prohibit ghostwriting and require disclosure of payments have been widespread over the past several years. As Dr. Lo acknowledged, ghostwriting has receded in recent years with tougher standards.

Nonetheless, to ensure public trust in medicine, transparency is always welcomed with physician-industry collaboration. While the letters published this week may appear to show an aspect of ghostwriting, it appears clear from Dr. Nemeroff and Schatzberg’s comments that such conduct is misstated.

Before proposing any changes to their grant system, the NIH should consider that plaintiff attorneys are largely behind this sudden move to disclose ghost writing.  These attorneys can then discredit those physicians and their research in court.  Given this fact, one may not consider calls for banning funding for those who worked on papers with writers in the pasts and were arbitrarily assigned the label of “ghost writing” a purely altruistic goal.

No one doubts that the practice of ghostwriting raises concerns about bias since the authors may not be appropriately acknowledged however, more attention needs to be paid to the entire writing of medical literature process. As in almost all professions, many people take different roles in producing finished products.

In Congress, staffers, attorneys, interns, and lobbyists help write laws, but their names do not appear on the bills, only the original sponsors and co-sponsors do. Sure, you can look up who the staffers may be, but you do not know what their interests are, other than maybe what party they are work for.

As long as researchers continue to adequately acknowledge whose idea it was, who were authors on the project, collaboration between industry and researchers to produce educational materials should be a priority because such relationships help teach and inform physicians how to help better treat patients.