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

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