Life Science Compliance Update

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November 02, 2012

Association of Clinical Researchers and Educators Releases Statement on Relationships Between Physicians and Industry

Medical Progress
Over the years, we have written about the relationships between the life sciences industry—manufacturers of pharmaceuticals, biologics, and medical devices—and healthcare providers and institutions.  Some have criticized these relationships because of what they allege to be their potential to lead to bias and “conflicts of interests.”  The criticisms have stemmed from several high profile cases, usually involving physicians who were conducting research for companies or some other form of work, but failed to disclose the financial relationships either in a medical journal or to their institution.  Corporate kickbacks and off-label product promotion are also among the common allegations and penalties.     

In response to these incidents, Congress launched investigations, the Department of Justice and many federal and state prosecutors, as well as the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS) began a long crusade to root out such disclosure lapses.  The culmination of this crusade occurred in 2010, when Congress passed the Affordable Care Act (ACA), which included the Physician Payment Sunshine Act, a provision that requires companies to report certain payments over $10 they make to teaching hospitals and doctors.   

In addition to these trends, professional medical associations, academic medical centers, and other federal, state, and private organizations, including guidelines committees and federal health agencies, have changed, created or amended their rules regarding interactions with industry.  Some have proposed banning all interactions physicians and entities have with industry.  Others have proposed putting severe restrictions in place.  While there may be strengths and weaknesses to these approaches, the best course is a middle road: one that values transparency of such relationships, but does not harm patients or slow innovation in the process. 

Achieving that middle ground, the Association of Clinical Researchers and Educators (ACRE) recently finalized its Guidelines on Relationships Between Physicians and Industry.  ACRE is a professional association of physicians dedicated to the pursuit of excellence in patient care, medical research and education.  ACRE members are physicians who recognize that meaningful progress in medical care demands collaboration between clinicians and others with the same commitment to research -- basic, translational and clinical – and to education.  This collaboration includes industries that invent, develop and manufacture medical products. 

“These Guidelines contain many provisions encompassed in existing academic, industry, professional society and other institutional examples but achieve a much more reasonable approach to managing such relationships so that physicians can actively participate in innovation and discovery of new treatments, and translational science, to enhance patient care and outcomes,” said J. Michael Gonzalez-Campoy, MD, PhD, FACE, ACRE member, and co-author of the guidelines. 

ACRE’s Guidelines will be published in the November/December issue of Endocrine Practice.  In addition, the ACRE guidelines will be available for download from the Endocrine Practice Website, www.endocrinepractice.org, for wide distribution. 

ACRE plans to roll out an educational campaign for academic medical centers, medical schools, and professional medical associations to educate physicians and researchers about the new guidelines.  Below is a summary of the various relationships the Guidelines cover.  

Statement on Physician-Industry Collaboration  

The vast majority of collaborations between physicians and industry has added considerably to improved patient care.  Moreover, these collaborations have been conducted with integrity and commitment.  Critics of these collaborations have raised concerns, largely speculative and theoretical, that have created complicated and counterproductive regulations and rules regarding these relationships.  

ACRE recognized that physicians have the experience and opportunity to identify unmet needs in clinical practice, to design innovative solutions, conduct pivotal clinical trials and through publications and teaching, to bring this new information to their colleagues and to patients. 

Industry has the resources and expertise to: (1) Discover new therapies and devise medical procedures; (2) Take these through the painstaking processes of basic research, clinical development and eventual production; (3) Deal with the related scientific, regulatory, legal, financial and manufacturing issues; and (4) Complement the skills and contributions of its academic and clinical partners. 

Medical Societies 

Corporate support of medical societies is of clear value to scientists and clinicians – and ultimately to their patients – and should be encouraged and widely supported.  Medical societies depend on partnerships with industry to maintain their missions.  Membership subscriptions alone do not meet medical society’s expenditures.  Medical society contributions by companies include: 

  • Corporate memberships; Educational grants; Symposia sponsorship
  • Exhibitor fees; Travel grants; Advertising in society journals; Underwriting printed programs and other publications 

Physician leadership of medical societies is vital to the effectiveness of societies and the fulfillment of their missions.  Relationships between physician leaders and industry can facilitate their joint involvement in research and education.  Physician leaders bring valuable industry contacts to medical societies and leadership in medical societies puts physicians in contact with industry. 

Accordingly, ACRE recommended that leaders of medical societies have a strong obligation to create internal operational procedures – professional compliance measures -- to ensure corporate support does not create inappropriate endorsements of industry products.  They also noted that societies should be proactive in protecting themselves and their corporate supporters against the appearance of inappropriate endorsements. 

Continuing Medical Education (CME) 

There is concern over industry-supported CME activities, which could lead to undue influence or creates bias.  However, ACRE recognized that there are already tremendous safeguards in place to minimize the risk of influence or bias.  The Accreditation Council for Continuing Medical Education (ACCME) Standards For Commercial Support ensure that CME programs carefully avoid explicit commercial interests concerning specific products and observe strict balance when products are discussed.   

Moreover, the absence of bias in CME programs has been documented in three large studies and several surveys have shown that practitioners value industry support of CME.  In addition, there are several industry codes, including the CME Coalition Code of Conduct, which ensure the integrity and evidence-based nature of commercially supported CME.  Consequently, ACRE made several recommendations regarding CME: 

  • Faculty members must ensure control over CME content
  • Standard disclosure procedures when relevant to subject
  • Primary goal of CME is met: to empower practitioners to provide improved care for their patients 
  • Faculty should assist in post-CME surveys that examine whether, in fact, attendees have changed practice strategies in response to what they learned at the event
  • Faculty should create their own talks
  • Speaker’s honorarium for industry sponsored CME should be pre-set by CME provider and commercial supporter   
  • Honoarium should be based on Fair Market Value 

Product-Specific or Promotional Education 

ACRE also made recommendations about industry-initiated educational events (e.g. “promotional”), in which companies must present FDA-approved information.  ACRE recommended that physician educators must not be considered marketers: 

  • Must be independent, avoid appearance of selling product
  • Will teaching contribute to improved patient care?

        –        Consider value of drugs, technologies, cost of intervention

  • Use experienced physician-educator
  • Accurate presentations to enhance clinician’s skills
  • Acceptable degree of intellectual freedom?
  • Work with industry to create presentation, if possible
  • Physician educators work with multiple sponsors
  • Don’t participate otherwise

Publishing 

There are five broad types of articles in which physicians and industry have common publishing interests: 

  • Major clinical trials with industry sponsorship
  • Investigator-initiated studies
  • Registration or post-approval programs
  • Derivative articles or reviews
  • Collaborative projects, not product-related 

ACRE recommended that for major studies, where physicians have exercised primary responsibility, the decision to publish articles should be made by the physician—either the Chair of the steering committee or the Principle Investigator of the study.  In addition: 

  • The physician role must be defined prior to study start
  • Cannot prevent or delay publication of unfavorable results
  • Writing monographs or textbooks, where publisher pays royalties to authors, is universally justified.
  • Establish how author will contribute to derivative/review article

–        Begin before outlines of article or any drafts are written 

ACRE said it is reasonable to accept analyses/data provided by sponsor, and sponsors should be granted right to review manuscripts; however, “ghostwriting” should be avoided and the use of external writing agencies or “editorial assistance” should be undertaken with great care.  ACRE noted that it is reasonable to use editorial assistance for those parts of research papers dealing with complex or detailed data that fall in the technical domain of specialized professional writers. 

Travel Expenses 

Legitimate reasons to fund physician travel include: 

  • Attendance at meeting where physician will present research arising from collaborative work with sponsor
  • Funding of travel grants for younger faculty or trainees at AMCs to attend scholarly meetings
  • Presentations at CME meetings, most often through a third party (organizer of CME event)
  • Investigator meetings for sponsored research
  • Expenses incurred for physicians serving as advisors, consultants, or doing work on behalf of the company on legal, regulatory affairs or R&D. 

ACRE recommends that Travel support should always be for legitimate reasons 

  • Industry sponsors have implemented standards for travel support
  • Travel support to attend a meeting as a member of the audience, not the faculty, should be declined
  • Acceptance of travel support must not be linked in any way to prescribing performance or other support of the sponsor’s products 

Research Activities 

There are several types of research activities: 

  • Sponsored clinical trials research
  • Often multi-center

–        Involves both academic and non-academic investigators

–        Investigator-initiated

–        Individual physicians solicit industry support

  • Basic research in clinical or non-clinical settings, sometimes linked to the licensing and further development of intellectual property (inventions) owned by individual physicians or institutions 

ACRE recognized the benefits of Clinical Research 

  • Advances in patient care
  • Advances in clinical or basic sciences
  • Assistance to industry in credible therapeutic development
  • Physician support and career growth
  • Participation as authors in publishing research papers
  • Research experience for fellows and other trainees at academic medical centers
  • The potential for financial support for training/fellow positions and related academic missions 

ACRE recommended that it should be clear why a relationship is being established:   

  • Are there true benefits (for example, those listed above)?
    • Establish the role of physicians from the beginning of an anticipated project (e.g. writing manuscript)
    • Be clear about the distribution of funding by sponsor
    • Establish how funds will be allocated at large institutions
    • Determine how the investigator will spend the money
    • Predetermine the use of any excess funds
    • Clinicians should receive fair value payment for their professional services (see below for definition of “fair market value”) 

Consulting and Advisory Activities 

ACRE recognized that consulting and advisory activities: 

  • Enable important exchanges of information and ideas
  • Research and education derived from these activities
  • Consulting activities include:

–        R&D of new or existing therapies

–        Resolving regulatory issues (e.g. FDA, CMS, HHS)

–        Review of safety and efficacy data

–        Corporate advisory boards and education (e.g. symposia)

–        Education (e.g. symposia, slide sets, society meetings)

–        Public relations (e.g. spokespersons)  

ACRE recommended that the relevance of involvement in these activities must be clear  

  • Unrelated to institution, clear time for this work
  • AMC’s may limits faculty involvement in consulting
  • Payments to clinicians must be fair market value
  • Public spokespersons

–        Avoid giving the impression of primarily defending industry interests

–        Use internal personnel to explain the company’s position

–        Faculty may explain scientific and clinical data arising from collaborative work in which they took part

–        Acceptable to explain scientific facts, even if not involved in research, if doing so is clearly in the public interest 

Fair Market Value 

ACRE recommended that physicians should negotiate payment with sponsors 

  • “Fair market value” should not be arbitrarily set by legal or regulatory officials within the sponsoring company
  • Payments should replace cost away from practice
  • Reasonable payments should be based on

–        Specialty income; geographic location

–        Type of effort involved

–        Incomes of fully-salaried medical school officials (e.g. dean)

–        The loss of practice income for physicians in private practice

–        Lost vacation days; travel; preparation for assignment

Disclosures 

ACRE recommended that  

  • Physicians must fully disclose all financial relationships with industry when serving on:

–     Formulary committees serving hospitals or other entities

–     Institutional review boards (IRBs) for proposed human research projects

–     Specialty care, using high cost drugs or interventions that may draw attention from payers and other observers

  • Financial relationships between physicians and industry, which are perfectly legitimate, should be disclosed when relevant

–        For publications

–        For research activities

–        Educational activities

–        Clinical activities

  • Disclosure of actual amounts of payments is superfluous, and is not appropriate
  • Disclosures should not be used by others as implications of impropriety
  • ACRE rejects the terms

–        “conflict of interest”

–        “competing interests”

  • ACRE strongly believes that “acknowledgement of support” is more appropriate and should be used in making disclosures of financial relationships by physician educators and researchers.

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