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].

Conflict of interest and fraud is also addressed by Medicare in the United States.[6]

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 [7] with amounts arranging from $100-$20,000.[8] Studies show that doctors can be influenced by drug company inducements, even by small gifts and food.[9][10] Industry-sponsored Continuing Medical Education (CME) programs influence prescribing patterns. [11] Many patients surveyed in one study agreed that physician gifts from drug companies influence prescribing practices. [12] 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. [13]

The quality and accuracy of industry promotion is questioned.[14][15]

Various groups have made relevant statements:

  • Pharmaceutical Research and Manufacturers of America (PhRMA)[16]
  • American Medical Association states "Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value."[17]
  • 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."[18]
  • Office of the Inspector General of Health and Human Services[19]
  • Institute of Medicine[20]
  • Brennan et al (sponsored by the American Board of Internal Medicine)[21]

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."[22]

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.[23][24].

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 [25].

Conflict of interest in research

Financial conflicts

Financial relationships with pharmaceutical manufacturers and authors' published positions.[26][27][28][29]
Controversy Pro Neutral Negative
Rosiglitazone
BMJ 1998[27]		 87% 24% 20%
Dihydropyridine calcium channel blockers
NEJM 2010[28]		 96% 60% 37%

In scientific journals, financial relationships with pharmaceutical manufacturers are associated with authors' published positions.[30][27][28] Faculty members[31][32] and institutions[33] 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.[34] Worse it has been reported that some published articles use 'ghost writers'.[35] Ghost writers may have a conflict of interest but this is not apparent since they are not credited as an author in the byline.

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.[36]

Regarding data analyses of randomized controlled trials, research sponsored by industry may incompletely report or analyze drug toxicity.[37][38] Similarly, industry-sponsored trials may be more likely to omit intention-to-treat analyses.[39] These problems with statistical analyses have led the Journal of the American Medical Association (JAMA) to require independent analysis of data.[40][41] This policy has been associated with a decreased in the number of trials published by JAMA.[42]

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.[43] Alternatively, the usefulness of drugs may be overstated, although, this is contentious since one study did not find evidence of overstatement.[44] 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.[45]

Industry sponsored research may be higher quality than other research in studies of obesity.[46]

Recommendations for researchers have been published for avoiding conflicts when writing papers.[47] However, rates of disclosure are incomplete.[48][49]

The pharmaceutical manufacturer Lilly has publicly disclosed its payments to physicians at http://www.lillyfacultyregistry.com/. The disclosure was mandated as part of a legal settlement regarding Lilly's marketing of Zyprexa.[50] Similarly, Pfizer is disclosing payments at http://www.pfizer.com/responsibility/working_with_hcp/payments_report.jsp in compliance with a settlement for illegal promotion of drugs for off-label uses.[51]

Industries other than pharmaceuticals, such as makers of medical devices, may be involved with conflict of interest.[52][53]

Non-financial conflicts

Non-financial conflicts of interest have been described in medical research.[54]

Conflicts of interests in health care institutions

Recommendations have been made for institutions.[55]

Vendor relationships

The American Psychiatric Association is reported to have 30% of its financing through the pharmaceutical industry.[56]

References

  1. ↑ 42USC1395nn Available at: 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. ↑ CMS. A Roadmap for New Physicians Avoiding Medicare and Medicaid Fraud and Abuse
  7. ↑ 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.
  8. ↑ 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.
  9. ↑ 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.
  10. ↑ Güldal D, Semin S (2000). "The influences of drug companies' advertising programs on physicians". Int J Health Serv 30: 585-95. PMID 11109183.
  11. ↑ Wazana A (2000). "Physicians and the pharmaceutical industry: is a gift ever just a gift?". JAMA 283: 373-80. PMID 10647801.
  12. ↑ Blake R, Early E. "Patients' attitudes about gifts to physicians from pharmaceutical companies". J Am Board Fam Pract 8: 457-64. PMID 8585404.
  13. ↑ [1] LA Times, "Drug money withdrawals: Medical schools review rules on pharmaceutical freebies," posted 2/12/07, accessed 3/6/07]
  14. ↑ Ziegler MG, Lew P, Singer BC (1995). "The accuracy of drug information from pharmaceutical sales representatives.". JAMA 273 (16): 1296-8. PMID 7715044. [e]
  15. ↑ Steinman MA, Bero LA, Chren MM, Landefeld CS (2006). "Narrative review: the promotion of gabapentin: an analysis of internal industry documents.". Ann Intern Med 145 (4): 284-93. PMID 16908919. [e]
  16. ↑ Pharmaceutical Research and Manufacturers of America. PhRMA Code on Interactions With Healthcare Professionals. July 1, 2002. Accessed Sept 3, 2008.
  17. ↑ Anonymous. AMA (Gifts to Phys CME) Ethical guidelines for gifts to physicians from industry. American Medical Association. Retrieved on 2008-09-03.
  18. ↑ Coyle SL (March 2002). "Physician-industry relations. Part 1: individual physicians". Ann. Intern. Med. 136 (5): 396–402. PMID 11874314. [e]
  19. ↑ US Department of Health and Human Services Office of Inspector General. Compliance program guidance for pharmaceutical manufacturers. Fed Regist. 2003;68(86):23731-23743
  20. ↑ Institute of Medicine (2009) Conflict of Interest in Medical Research, Education, and Practice
  21. ↑ Brennan TA, Rothman DJ, Blank L, Blumenthal D, Chimonas SC, Cohen JJ et al. (2006). "Health industry practices that create conflicts of interest: a policy proposal for academic medical centers.". JAMA 295 (4): 429-33. DOI:10.1001/jama.295.4.429. PMID 16434633. Research Blogging.
  22. ↑ Report of the AAMC Taskforce on Industry Funding of Medical Education to the AAMC Executive Council. Accessed Dec 19, 2012.
  23. ↑ 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.
  24. ↑ 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.
  25. ↑ Gartrell N et al. (1992). "Physician-patient sexual contact. Prevalence and problems". West J Med 157: 139-43. PMID 1441462.
  26. ↑ Bekelman JE, Li Y, Gross CP (2003). "Scope and impact of financial conflicts of interest in biomedical research: a systematic review.". JAMA 289 (4): 454-65. PMID 12533125. [e]
  27. ↑ 27.0 27.1 27.2 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] Cite error: Invalid <ref> tag; name "pmid9420342" defined multiple times with different content
  28. ↑ 28.0 28.1 28.2 Wang AT, McCoy CP, Murad MH, Montori VM (2010). "Association between industry affiliation and position on cardiovascular risk with rosiglitazone: cross sectional systematic review.". BMJ 340: c1344. DOI:10.1136/bmj.c1344. PMID 20299696. Research Blogging. Cite error: Invalid <ref> tag; name "pmid20299696" defined multiple times with different content
  29. ↑ Fugh-Berman, Adriane; Christina Pike McDonald, Alicia M. Bell, Emily Catherine Bethards, Anthony R. Scialli (2011-03-15). "Promotional Tone in Reviews of Menopausal Hormone Therapy After the Women's Health Initiative: An Analysis of Published Articles". PLoS Med 8 (3): e1000425. DOI:10.1371/journal.pmed.1000425. Retrieved on 2011-03-16. Research Blogging.
  30. ↑ Warner TD, Gluck JP (2003). "What do we really know about conflicts of interest in biomedical research?". Psychopharmacology (Berl) 171 (1): 36-46. DOI:10.1007/s00213-003-1657-x. PMID 14624332. Research Blogging.
  31. ↑ 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]
  32. ↑ 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]
  33. ↑ 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]
  34. ↑ 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]
  35. ↑ Laine C, Mulrow CD (2005). "Exorcising ghosts and unwelcome guests". Ann Intern Med 143: 611–2. PMID 16230729. [e]
  36. ↑ 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.
  37. ↑ Psaty BM, Kronmal RA (2008). "Reporting mortality findings in trials of rofecoxib for Alzheimer disease or cognitive impairment: a case study based on documents from rofecoxib litigation.". JAMA 299 (15): 1813-7. DOI:10.1001/jama.299.15.1813. PMID 18413875. Research Blogging.
  38. ↑ Madigan D, Sigelman DW, Mayer JW, Furberg CD, Avorn J (2012). "Under-reporting of cardiovascular events in the rofecoxib Alzheimer disease studies.". Am Heart J 164 (2): 186-93. DOI:10.1016/j.ahj.2012.05.002. PMID 22877803. Research Blogging.
  39. ↑ 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.
  40. ↑ DeAngelis CD, Fontanarosa PB (2010). "Ensuring integrity in industry-sponsored research: primum non nocere, revisited.". JAMA 303 (12): 1196-8. DOI:10.1001/jama.2010.337. PMID 20332409. Research Blogging.
  41. ↑ Fontanarosa PB, Flanagin A, DeAngelis CD (2005). "Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies.". JAMA 294 (1): 110-1. DOI:10.1001/jama.294.1.110. PMID 15998899. Research Blogging.
  42. ↑ Wager E, Mhaskar R, Warburton S, Djulbegovic B (2010). "JAMA published fewer industry-funded studies after introducing a requirement for independent statistical analysis.". PLoS One 5 (10): e13591. DOI:10.1371/journal.pone.0013591. PMID 21042585. PMC PMC2962640. Research Blogging.
  43. ↑ 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.
  44. ↑ 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]
  45. ↑ 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.
  46. ↑ Thomas O, Thabane L, Douketis J, Chu R, Westfall AO, Allison DB (2008). "Industry funding and the reporting quality of large long-term weight loss trials.". Int J Obes (Lond) 32 (10): 1531-6. DOI:10.1038/ijo.2008.137. PMID 18711388. PMC PMC2753515. Research Blogging.
  47. ↑ Adriane J Fugh-Berman (2008-12-22). Ethical considerations of publication planning in the pharmaceutical industry (Text.Serial.Journal). Retrieved on 2008-12-26.
  48. ↑ Tatsioni A, Siontis GC, Ioannidis JP (2010). "Partisan perspectives in the medical literature: a study of high frequency editorialists favoring hormone replacement therapy.". J Gen Intern Med 25 (9): 914-9. DOI:10.1007/s11606-010-1360-7. PMID 20425148. PMC PMC2917671. Research Blogging.
  49. ↑ Susan Chimonas; Zachary Frosch; David J. Rothman From Disclosure to Transparency: The Use of Company Payment Data Arch Intern Med. 2010. DOI:archinternmed.2010.341
  50. ↑ Lilly to Pay $22.5 Million to Settle Zyprexa Suit (Update3) - Bloomberg.com. Retrieved on 2009-10-29.
  51. ↑ Wilson D (2010) Pfizer Gives Details on Payments to Doctors New York Times
  52. ↑ Meier, B; Wilson, D. (2011) Spine Experts Repudiate Medtronic Studies. New York Times
  53. ↑ Anonymous (2011) The Spine Journal Calls for End to “Years of Living Dangerously” in Promotion of Bone Growth Factors. North American Spine Society
  54. ↑ Making Sense of Non-Financial Competing Interests The PLoS Medicine Editors PLoS Medicine Vol. 5, No. 9, e199 DOI:10.1371/journal.pmed.0050199
  55. ↑ Lo, Bernard[Commentary: Conflict of Interest Policies: An Opportunity for the Medical Profession to Take the Lead http://journals.lww.com/academicmedicine/Fulltext/2010/01000/Commentary__Conflict_of_Interest_Policies__An.9.aspx]. Academic Medicine: January 2010 - Volume 85 - Issue 1 - pp 9-11 DOI:10.1097/ACM.0b013e3181c46e96
  56. ↑ Benedict Carey, Gardiner Harris (July 12, 2008). Psychiatric Group Faces Scrutiny Over Drug Industry Ties. New York Times.
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