Conflict of interest

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Conflicts of interest in health care

Conflict of interest in health care is addressed by the Stark Law (42 CFR 411 350 through 389[1][2]). More information is at http://starklaw.org/.

Conflicts of interests in individual health care providers

A health care, a conflict of interest is a "situation in which an individual might benefit personally from official or professional actions. It includes a conflict between a person's private interests and official responsibilities in a position of trust. The term is not restricted to government officials. The concept refers both to actual conflict of interest and the appearance or perception of conflict."[3]

"A physician shall, while caring for a patient, regard responsibility to the patient as paramount." Article VIII of the AMA Principles of medical ethics

Physicians should not allow a conflict of interest to influence medical judgment. In some cases, conflicts are hard to avoid, and doctors have a responsibility to avoid entering such situations.

For example, doctors who receive income from referring patients for medical tests have been shown to refer more patients for medical tests [4]. This practice is proscribed by the American College of Physicians Ethics Manual [5].

Vendor relationships

In the USA, a survey reported that 28% of practicing physicians reported receiving money from industry for consulting, giving lectures, or enrolling patients in trials [6] with amounts arranging from $100-$20,000.[7] Studies show that doctors can be influenced by drug company inducements, even by small gifts and food.[8][9] Industry-sponsored Continuing Medical Education (CME) programs influence prescribing patterns. [10] Many patients surveyed in one study agreed that physician gifts from drug companies influence prescribing practices. [11] A growing movement among physicians is attempting to diminish the influence of pharmaceutical industry marketing upon medical practice, as evidenced by Stanford University's ban on drug company-sponsored lunches and gifts. Other academic institutions that have banned pharmaceutical industry-sponsored gifts and food include the University of Pennsylvania, and Yale University. [12]

Various groups have made relevant statements:

  • Pharmaceutical Research and Manufacturers of America (PhRMA)[13]
  • American Medical Association states "Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value."[14]
  • American College of Physicians states "The acceptance of individual gifts, hospitality, trips, and subsidies of all types from industry by an individual physician is strongly discouraged."[15]
  • Office of the Inspector General of Health and Human Services[16]

The most rigorous statement is by the American Association of Medical Colleges (AAMC):

  • American Association of Medical Colleges states "Academic medical centers should establish and implement policies that

prohibit the acceptance of any gifts from industry by physicians and other faculty, staff, students, and trainees of academic medical centers, whether on-site or off-site."[17]

Treatment of family members

Many doctors treat their family members. Doctors who do so must be vigilant not to create conflicts of interest or treat inappropriately.[18][19].

Sexual relationships

Sexual relationships between doctors and patients can create ethical conflicts, since sexual consent may conflict with the fiduciary responsibility of the physician. Doctors who enter into sexual relationships with patients face the threats of deregistration and prosecution. It is estimated that between 2% and 9% of doctors have violated this rule based on a study in the early 1990s [20].

Conflict of interest in research

Financial conflicts

Financial relationships with pharmaceutical manufacturers are associated with authors' published positions.[21] Faculty members[22][23] and institutions[24] with entrepreneurial relationships are associated with data withholding from colleagues or publication (publication bias).

In any publication, there is always some issue with regard to conflict of interest. All the work by scientists is funded by groups such as charities, public bodies or private industry. Accordingly there could be pressure to overstate any outcomes or bias a trial to favor a particular outcome. Unfortunately, the presence of authors with a conflict of interest is not reliably indicated in journal articles.[25] Worse it has been reported that some published articles use 'ghost writers'.[26] Ghost writers may have a conflict of interest but this is not apparent since they are not credited as an author in the byline. Finally, academic scientists gain their professional reputations by publishing in quality journals and purely factual summaries do not necessarily impress journal editors any more than they inspire casual readers.

In the design of randomized controlled trials, industry-sponsored studies may be more likely to select an inappropriate comparator group that would favor finding benefit in the experimental group. This may manifest itself by comparing the effectiveness of a new drug with the effectiveness of an established older treatment rather than choosing a competitors current treatment for comparison.[27] When reporting data from randomized controlled trials, industry-sponsored studies may be more likely to omit intention-to-treat analyses.[28] Regarding the conclusions reached in randomized controlled trials, industry sponsored studies may be more likely to conclude that drugs are safe, even when they have increased adverse effects.[29] Alternatively, the usefulness of drugs may be overstated, although, this is contentious since one study did not find evidence of overstatement.[30] in contrast, a later study found that industry sponsored studies are more likely to recommend the experimental drug as treatment of choice even after adjusting for the treatment effect.[31]

Obviously a pharmaceutical company wants to report that its drug is better than a competitor's drug, or better than no treatment; however, due to the threat of litigation, it is not in their interests to suppress or minimise evidence of harm. For the scientists who are conducting the trials, however, the perspective might be different: if it becomes clear that a drug is useless or harmful, then the company will cease to work on the drug and a scientists livelihood could be threatened. Consequently, the responsibility for the integrity of the design and analysis of studies lies squarely with the authors. If the scientists involved in any trial are lacking in competence or integrity, then this will prejudice the value of a trial both for the public and indeed for their industrial sponsors.

Recommendations have been published for avoiding conflicts when writing papers.[32]

Non-financial conflicts

Non-financial conflicts of interest have been described in medical research.[33]

Conflicts of interests in health care institutions

Vendor relationships

The American Psychiatric Association is reported to have 30% of its financing through the pharmaceutical industry.[34]

References

  1. ↑ 42USC1395nn Cornell Law School: Legal Information Institute
  2. ↑ “[Exclusions From Medicare and Limitations on Medicare Payment]” Title 42 Code of Federal Regulations, Pt. 411. 2008 ed
  3. ↑ Anonymous (2024), Conflict of interest (English). Medical Subject Headings. U.S. National Library of Medicine.
  4. ↑ Swedlow A et al. (1992). "Increased costs and rates of use in the California workers' compensation system as a result of self-referral by physicians". N Engl J Med 327: 1502-6. PMID 1406882.
  5. ↑ (1998) "Ethics manual. Fourth edition. American College of Physicians". Ann Intern Med 128 (7): 576-94. PMID 9518406.
  6. ↑ Campbell EG et al. (2007). "A national survey of physician-industry relationships". N Engl J Med 356: 1742–50. DOI:10.1056/NEJMsa064508. PMID 17460228. Research Blogging.
  7. ↑ Ross JS et al. (2007). "Pharmaceutical company payments to physicians: early experiences with disclosure laws in Vermont and Minnesota". JAMA 297: 1216–23. DOI:10.1001/jama.297.11.1216. PMID 17374816. Research Blogging.
  8. ↑ Grande D, Frosch DL, Perkins AW, Kahn BE (May 2009). "Effect of exposure to small pharmaceutical promotional items on treatment preferences". Arch. Intern. Med. 169 (9): 887–93. DOI:10.1001/archinternmed.2009.64. PMID 19433701. Research Blogging.
  9. ↑ Güldal D, Semin S (2000). "The influences of drug companies' advertising programs on physicians". Int J Health Serv 30: 585-95. PMID 11109183.
  10. ↑ Wazana A (2000). "Physicians and the pharmaceutical industry: is a gift ever just a gift?". JAMA 283: 373-80. PMID 10647801.
  11. ↑ Blake R, Early E. "Patients' attitudes about gifts to physicians from pharmaceutical companies". J Am Board Fam Pract 8: 457-64. PMID 8585404.
  12. ↑ [1] LA Times, "Drug money withdrawals: Medical schools review rules on pharmaceutical freebies," posted 2/12/07, accessed 3/6/07]
  13. ↑ Pharmaceutical Research and Manufacturers of America. PhRMA Code on Interactions With Healthcare Professionals. July 1, 2002. Accessed Sept 3, 2008.
  14. ↑ Anonymous. AMA (Gifts to Phys CME) Ethical guidelines for gifts to physicians from industry. American Medical Association. Retrieved on 2008-09-03.
  15. ↑ Coyle SL (March 2002). "Physician-industry relations. Part 1: individual physicians". Ann. Intern. Med. 136 (5): 396–402. PMID 11874314. [e]
  16. ↑ US Department of Health and Human Services Office of Inspector General. Compliance program guidance for pharmaceutical manufacturers. Fed Regist. 2003;68(86):23731-23743
  17. ↑ Report of the AAMC Taskforce on Industry Funding of Medical Education to the AAMC Executive Council. Accessed Sept 3, 2008.
  18. ↑ La Puma J et al. (1991). "When physicians treat members of their own families. Practices in a community hospital". N Engl J Med 325: 1290-4. PMID 1922224.
  19. ↑ La Puma J, Priest E (1992). "Is there a doctor in the house? An analysis of the practice of physicians' treating their own families". JAMA 267: 1810-2. PMID 1545466.
  20. ↑ Gartrell N et al. (1992). "Physician-patient sexual contact. Prevalence and problems". West J Med 157: 139-43. PMID 1441462.
  21. ↑ Stelfox HT, Chua G, O'Rourke K, Detsky AS (1998). "Conflict of interest in the debate over calcium-channel antagonists". N Engl J Med 338: 101–6. PMID 9420342. [e]
  22. ↑ Blumenthal D, Campbell EG, Anderson MS, Causino N, Louis KS (1997). "Withholding research results in academic life science. Evidence from a national survey of faculty". JAMA 277: 1224–8. PMID 9103347. [e]
  23. ↑ Blumenthal D et al. (1996). "Participation of life-science faculty in research relationships with industry". N Engl J Med 335: 1734–9. PMID 8929266. [e]
  24. ↑ Blumenthal D et al. (1996). "Relationships between academic institutions and industry in the life sciences--an industry survey". N Engl J Med 334: 368–73. PMID 8538709. [e]
  25. ↑ Papanikolaou GN et al. (2001). "Reporting of conflicts of interest in guidelines of preventive and therapeutic interventions". BMC medical research methodology 1: 3. PMID 11405896. [e]
  26. ↑ Laine C, Mulrow CD (2005). "Exorcising ghosts and unwelcome guests". Ann Intern Med 143: 611–2. PMID 16230729. [e]
  27. ↑ Lexchin J et al. (2003). "Pharmaceutical industry sponsorship and research outcome and quality: systematic review". BMJ 326: 1167–70. DOI:10.1136/bmj.326.7400.1167. PMID 12775614. Research Blogging.
  28. ↑ Melander H et al. (2003). "Evidence b(i)ased medicine--selective reporting from studies sponsored by pharmaceutical industry: review of studies in new drug applications". BMJ 326: 1171–3. DOI:10.1136/bmj.326.7400.1171. PMID 12775615. Research Blogging.
  29. ↑ Nieto A et al. (2007). "Adverse effects of inhaled corticosteroids in funded and nonfunded studies". Arch Intern Med 167: 2047–53. DOI:10.1001/archinte.167.19.2047. PMID 17954797. Research Blogging.
  30. ↑ Friedberg M et al. (1999). "Evaluation of conflict of interest in economic analyses of new drugs used in oncology". JAMA 282: 1453–7. PMID 10535436. [e]
  31. ↑ Als-Nielsen B et al. (2003). "Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events?". JAMA 290: 921–8. DOI:10.1001/jama.290.7.921. PMID 12928469. Research Blogging.
  32. ↑ Adriane J Fugh-Berman (2008-12-22). Ethical considerations of publication planning in the pharmaceutical industry (Text.Serial.Journal). Retrieved on 2008-12-26.
  33. ↑ Making Sense of Non-Financial Competing Interests The PLoS Medicine Editors PLoS Medicine Vol. 5, No. 9, e199 DOI:10.1371/journal.pmed.0050199
  34. ↑ Benedict Carey, Gardiner Harris (July 12, 2008). Psychiatric Group Faces Scrutiny Over Drug Industry Ties. New York Times.
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