Commercialism, Loss of Professionalism

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Commercialism,Loss of ProfessionalismEffect
on Journals

• Thomas J Liesegang MD
• Editor in Chief
• American Journal of Ophthalmology
• No Financial Disclosure
• Opinions expressed are solely those of the Author

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EDITORSHIP SERIES
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Ghost Authors andGuest Authors
Responsibility of Authors,Reviewers, Editors
Publication Bias andother Biases
Ethical Obligations inPublication
The termSafe and Effective
Influence of PharmaceuticalCompanies on
publications
The Open AccessInitiative
Maintaining Public Trustin Medical Journals
Presentation beforePublication (Ingelfinger Rule)
Meaning of InformedConsent
Improving ReportingMethods in Research
Role of InstitutionalReview Boards
Revealing the Faultsof Medical Journals
Clinical Trial RegistrationControl of data
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THREATS TO MEDICALPROFESSIONALISM
THE COMMERCIALISMOF MEDICINE
DEVALUATION OF PROFESSIONALISM
COMMERCIALISMSEFFECT ON JOURNALS
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Medicine is a Profession,Not an Economic Market

• Medicine is THE prototype profession,
  incorporating
• Specific body of knowledge
• Competence in defining problems solutions
• Commitment to self-improvement, self monitoring,
  self regulation
• System of admission monitoring new members
• Ethical responsibility to use the unique
  knowledge competence for the best interests of
  patients
• In recognition of certain conduct, society
  confers professional status to physicians
• This privilege must be repeatedly earned to
  preserve status

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Is the Medical ProfessionFor Sale?
Everything has either a price, or it possesses
dignity--- Immanual Kant
Personal financial choices by physicians at
times violate professional responsibilities
the fundamental ethical pact with society
Professionals should be independent of the state
or commerce --- RS Downie
Commercialism is incompatible with medical
professionalism --- Marcia Angell
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Conflict Between Commercialism Professionalism

• Appropriate inappropriate (not legal versus
  illegal) ways that physicians should make money
  contribute to society
• If the public perceives that physicians are not
  behaving as professionals, medicine surrenders
  its influence status in society
• Can the medical profession survive the secular
  culture of commercialism?
• Can the peer reviewed literature maintain the
  public trust?

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Technology Transfer Has Risks

• Bayh-Dole Act (USA) permitted universities to
  commercialize products inventions (technology
  transfer)
• Must preserve the benefits of this collaboration
  BUT prevent the marketing goal of industry from
  dominating the scientific goals of commercially -
  funded research
• Patients depend on MDs for unbiased medical
  information
• Health care industry goal is fiduciary to its
  shareholders
• Many reports (books, articles) now discuss
  CONCERNS
• Power of the pharmaceutical industry
• Corrupting influence of commercialism in medicine
• How the public trust in medicine is jeopardized

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Industry LargesseAcademic Institutions and/or
Individuals Now Receive

• Gifts, meals, books
• Free CME
• Payments for speakers bureaus, boards,
  consulting on marketing issues
• Payments for enrolling in clinical trials
• Participation in research studies with payment in
  stock
• Research sponsorship

Creates both the presumption reality of bias
Human behavior the rule of reciprocation
tenet Repay, in kind, what another person has
provided to you
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MDs Relationship with Pharmaceutical Industry
(USA)

• 94 report a relationship with the
  pharmaceutical industry
• Food in the workplace (83)
• Drug samples (78)
• Reimbursement for CME (35)
• Consulting, giving lectures, or enrolling
  patients in trials (25)

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MDs Relationship with Pharmaceutical Industry
(USA)

• 60 of department chairs have relationship with
  industry
• 90,000 drug representatives in USA
• 16 billion a year on marketing to doctors
• NIH unable to prohibit outside consulting
• Panels of scientific experts advising a federal
  decision making body are now heavily financially
  conflicted

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Industry KOLs Allegiance (USA)

• Companies target orchestrate academic Key
  Opinion Leaders (KOLs)
• Populate scientific advisory committees,
  speakers' bureaus manuscript writing committees
• KOLs seem convinced of their own impartiality!
• Challenged by moral philosophers the literature

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Industry KOLs Allegiance (USA)

• Consulting with multiple companies does not
  increase their objectivity
• Industry is acutely aware of the conflict between
  patient vulnerability profit incentives
• Pharmaceutical firms have voluntarily begun to
  regulate themselves

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Industry KOLs Allegiance (USA)

• Physicians behavior remains egregious by
• Permitting pharmaceutical and biotech industries
  to insinuate manipulate medical science through
  financial relationships
• Abrogating their responsibility to advance true
  or important science
• Sometimes authors are not even cognizant of the
  implications of their obvious financial ties
• Need to be told they have a conflict publicly
  reprimanded

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Commercialism is NOT theNorm in Medicine

• Medical care is not just another economic service
• Financial success has become the dominant
  standard of measurement or value even for
  most academic medical centers
• Young professionals need to know that these
  activities were previously considered
  unprofessional
• Should the profession try to uphold traditional
  principles?
• OR
• Alter the concept of a professional within the
  contemporary medical practice

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Goals of Profession Industry Differ

• Cooperation between academia industry is
  essential
• But, the engagement should be at a distance
• Disclosure as the mechanism to cleanse the
  system seems inadequate
• Reader or buyer beware should not be the mantra
  of a Profession

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Industry-Profession TensionJournals

• JOURNALS
• Accept articles based on capacity to improve
  patient care
• Must preserve their integrity as disseminators of
  unbiased, valid, credible, unfettered science
• INDUSTRY
• Can enhance value to shareholders by funding
  research influencing the peer reviewed
  literature
• Has ability to spin the message about how
  patients physicians should interpret a study
• 160 billion worth of pharmaceuticals in USA each
  year

CONCERN Marketing goal has the potential to
dominate the supposedly scientific aspect of
company-funded research
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Concern of Journals About Commercial Research
(USA)

• Before 1980s, academic medical centers designed
  the protocols, analyzed the results produced
  the peer reviewed scientific literature
• Bayh-Dole Act 70 of therapeutic trials are
  funded by an industry that might produce the
  protocols, analyze the data in-house, write up
  the articles
• Annual contract research organizations-industry
  revenues have increased from about 7 billion in
  2001 to 17.8 billion in 2007 (USA)
• Editors TRUST that the authors have employed an
  appropriate scientific skepticism when viewing
  their own data that the results discussion
  presented in an objective scientific fashion that
  others can believe can duplicate
• Editors peer reviewers can detect faulty
  reasoning and logic, can judge how the study was
  designed executed whether appropriate
  statistics were applied, but otherwise the peer
  reviewers simply TRUST that the authors have
  reigned in the commercial biases

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List of Commercial Research Irregularities
affecting the Literature

• Fraud dishonesty or falsifying data
• Altering design of studies to create positive
  results
• Canceling / delaying reports of studies
• Burying unfavorable/ negative results
• Incomplete reporting of serious adverse events
• Concealing clinical trial data showing harm
• Refusal to provide all study data to the
  principle investigator
• Reporting only short term data when longer term
  data is available
• Inappropriate influence in study data
  statistical analysis
• Failure to provide data for independent
  statisticians to confirm
• Ghostwriting by marketing departments

• Contracts with researchers that prohibit the
  publication of negative results
• Permitting industry rather than the researchers
  to determine publication
• Exaggerated claims in ads
• Multiple publications without acknowledgement
• Selective publication selective reporting
• Overbearing sponsor control over academic
  randomized trials
• Delayed publication to allow for patent
  application, protect their scientific lead, or to
  slow the dissemination of results that would hurt
  sales of their sponsor's product.
• Universities refusal to share results with their
  colleagues.
• Trial outcomes incomplete, biased,
  inconsistent with protocols

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Reliability of Some Commercial Funded Trials?

• At least 8 studies show that researchers with
  ties to drug companies are more likely to report
  results that are favorable to the products of
  those companies than researchers without such
  ties (e.g. non-profit entity or the federal
  government)
• Drummund Rennie Peer reviewed literature is
  Happy Talk
• Poor /False studies hurt the literature might
  never be corrected
• Unreliable overestimate the benefits of an
  intervention
• Meta analysis simply amplifies these erroneous
  results

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The Sin of Professional Omission

• Many important questions are NOT being answered
  in medicine
• Best researchers are utilizing their resources to
  answer industrys marketing queries, many of
  which have little substantial scientific research
  hypothesis
• Faculty is distracted from their teaching duties
  
• Marketing research projects lead to secrecy in
  research with the subsequent privatization of
  medical knowledge, to the detriment of society

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Disclosure is Not a Panacea

• Readers ( experts) usually cannot assess a
  persons motives guess whether his actions may
  have been affected by any financial disclosures
• In 1997 surveyed 61,134 articles in some 181
  journals
• Only 0.5 percent disclosed a conflict of interest
  related to the topic of the article (impossible!)
• Journals try to ensure that readers are aware of
  the authors' financial relationships
• This reader beware warning fosters an unfounded
  concept that disclosure to the journal is
  sufficient to resolve problems created by
  physicians COI
• Disclosure never resolves any issue it is
  simply an (weak) attempt to manage the conflict

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Pervasiveness of Conflicts

• In 2000, NEJM disclosure was not sufficient to
  preserve the integrity of the science that
  appeared in her journal's pages and that a policy
  of caveat emptor is not enough for readers who
  depend on the opinion of editorialists"
• Between 1974 and 2000, no editors or statistical
  consultants at the NEJM were allowed to have
  financial arrangements
• NEJM can no longer attain this goal!

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Role of Journals in Managing Conflicts

• Journals have no police force / investigative
  patrol
• Small journals have even fewer resources
• Require full reporting of financial disclosures
• If questioned by informed readers, full
  investigation - usually thru IRB, Deans,
  Department Chairs
• Dedicated to clarifying the situation for the
  reader
• Realize that literature is BIASED toward positive
  results meta-analysis magnifies the bias

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Impugning the Integrity of Medical
ScienceRecommendations of Catherine DeAngelis
MD

• Clinical Trials Registered with Principle
  Investigator
• Financial relationships disclosed
• Funding sources considered in Peer Review process
• Academics should control data report, not
  industry
• Statistics should be repeated by Academic
• Peer reviewers must maintain confidentiality

• Authorship criteria fulfilled
• NO guest authorship
• Prefer NO ghost authors at least reveal ghost
  authors
• Editors that can be manipulated should QUIT
• CME should NOT be funded or sponsored by industry
• MDs should NOT serve on speakers bureaus or
  accept gifts

Editor in Chief, JAMA 299 1833April 16,
2008
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