Commercialism, Loss of Professionalism & Effect on Journals

1. Commercialism,Loss of Professionalism&Effect on Journals Thomas J Liesegang MD Editor in Chief American Journal of Ophthalmology No Financial Disclosure Opinions expressed are solely those of the Author

2. EDITORSHIP SERIES

3. Responsibility of Authors,Reviewers, Editors Ghost Authors andGuest Authors Publication Bias andother Biases Ethical Obligations inPublication Influence of PharmaceuticalCompanies on publications The term“Safe and Effective” Maintaining Public Trustin Medical Journals The Open AccessInitiative Meaning of InformedConsent Presentation beforePublication (Ingelfinger Rule) Improving ReportingMethods in Research Role of InstitutionalReview Boards Revealing the Faultsof Medical Journals Clinical Trial Registration;Control of data

4. THREATS TO MEDICALPROFESSIONALISM THE COMMERCIALISMOF MEDICINE DEVALUATION OF PROFESSIONALISM COMMERCIALISM’SEFFECT ON JOURNALS

5. 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

6. 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

7. 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?

8. “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

9. Industry LargesseAcademic Institutions and/or Individuals Now Receive: • Gifts, meals, books • Free CME • Payments for speaker’s 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

10. 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%)

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. Industry-Profession Tension:Journals 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

18. 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

19. 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 List of Commercial Research Irregularities affecting the Literature

20. 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

21. The Sin of Professional Omission • Many important questions are NOT being answered in medicine • Best researchers are utilizing their resources to answer industry’s 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

22. “Disclosure” is Not a Panacea • Readers (& experts) usually cannot assess a person’s 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

23. 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!

24. 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

25. 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 Impugning the Integrity of Medical Science:Recommendations of Catherine DeAngelis MD* *Editor in Chief, JAMA 299: 1833April 16, 2008