Medical ethics: Difference between revisions

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==References==
==References==
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==External links==
* [http://jme.bmjjournals.com/ BMJJournals.com] - An international peer review journal for health professionals and researchers in medical ethics
* [http://www.publicationethics.org.uk/guidelines Committee on Publication Ethics] COPE is a forum for editors of peer-reviewed journals in biomedical sciences to discuss issues related to the integrity of the scientific record. Cope publishes guidelines on good practice for editors, and reports on breaches of ethics.

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Medical ethics is the study of moral values as they apply to medicine. In many cases, moral values can be in conflict, and ethical crises can result.

Medical ethics shares many principles with other branches of healthcare ethics, such as nursing ethics.

Writers about medical ethics have suggested many methods to help resolve conflicts involving medical ethics. Sometimes, no good solution to a dilemma in medical ethics exists, and occasionally, the values of the medical community (i.e., the hospital and its staff) conflict with the values of the individual patient, family, or larger non-medical community.

Values in medical ethics

A Case Method To Assist Clinical Ethics Decision Making (Modified from American College of Physicians, Ethics Manual, Fourth Edition)

1. Define the ethics problem as an "ought" or "should" question. (e.g." "Should we withhold a respirator for this unconscious adult man with AIDS, as his partner requests, or use it, as his parents request?")

2. List significant facts and uncertainties that are relevant to the question. Include facts about the patient and caregivers (such as emotional state, ethnic and cultural background, and legal standing). Include physiologic facts and significant medical uncertainties (such as expected outcomes with and without treatment), and the benefits and harms of the treatment options.

3. Identify a decision maker. If the patient is competent, the decision maker is the patient. If the patient is incompetent or lacks decision-making capacity, identify a proxy decision maker as specified by court appointment, state law, a durable power of attorney for health care, living will, or the persons who are best situated by virtue of their intimate, loving familiarity with the patient.

4. Give understandable, relevant, desired information to the decision maker and dispel myths and misconceptions.

5. Solicit values of the patient that are relevant to the question. These include the patient's values about life; relation to community, health care, and health care institutions; goals for health care and conditions that would change goals; and relevant preferences about health care or proxy decision makers.

6. Identify health professional values, including health goals (such as prolonging life and alleviating pain), values that pertain to patient–physician communication (such as truth telling and confidentiality), and some values that extend outside of the patient–physician relationship (such as promotion of public health, and respect for the law).

7. Propose and critique solutions, including options for treatment and alternative providers.

8. Identify and remove or address constraints on solutions (such as unavailability of services, laws, or legal myths).

Six values that often apply to medical ethics discussions include:

  • Beneficence - a practitioner should act in the best interest of the patient. (Salus aegroti suprema lex.)
  • Non-maleficence - "first, do no harm" (primum non nocere).
  • Autonomy - the patient has the right to refuse or choose their treatment. (Voluntas aegroti suprema lex.)
  • Justice - concerns the distribution of scarce health resources, and the decision of who gets what treatment.
  • Dignity - the patient (and the person treating the patient) have the right to dignity.
  • Truthfulness and honesty - the concept of informed consent has increased in importance since the historical events of the Nuremberg trials and Tuskegee Syphilis Study

These values do not give answers as to how to handle a particular situation, but they can provide a useful framework for understanding conflicts. There are often conflicts in ethical values between the patient and family, and the medical care providers, and these can lead to ethical dilemmas. Conflicts can also arise between health care providers, or among family members. For example, the principles of autonomy and beneficence clash when patients refuse life-saving blood transfusion, and truth-telling was not strongly emphasized before the HIV era.

In the United Kingdom, the General Medical Council provides guidance in the form of its 'Good Medical Practice' statement.

Informed consent

For more information, see: Informed consent.

Informed Consent in ethics usually refers to the idea that someone who is not adequately informed about the full implications of a decision about his or her treatment is at risk of mistakenly making a choice not reflective of his or her ethical values. It does not specifically mean the process of obtaining consent, nor the legal requirements for decision-making capacity. Patients can choose to make their own medical decisions, or can delegate this authority to someone else. Sometimes, the patient may be incapacitated, in which case U.S. State law designates a process for obtaining informed consent. In some American States, family members have differing levels of precedence over one another in making medical decisions for the patient, while other States recognize all family members equally in making medical decisions.

The value of informed consent is closely related to the values of autonomy and truth telling. American culture places a high value on these principles, finding justification in the U.S. Constitution and Declaration of Independence.

Confidentiality

For more information, see: Confidentiality.

"Confidentiality is a fundamental tenet of medical care. It is a matter of respecting the privacy of patients, encouraging them to seek medical care and discuss their problems candidly, and preventing discrimination on the basis of their medical conditions." American College of Physicians, Ethics Manual, Fourth Edition

"A physician shall respect the rights of patients, colleagues, and other health professionals, and shall safeguard patient confidences and privacy within the constraints of the law." AMA Principles of Medical Ethics

Confidentiality is commonly applied to conversations between doctors and patients. This concept is commonly known as patient-physician privilege. Legal protections prevent physicians from revealing their discussions with patients, even under oath in court. Confidentiality is mandated in the USA by HIPAA laws, specifically the Privacy Rule. Confidentiality is challenged in cases such as the diagnosis of a sexually transmitted disease in a patient who refuses to reveal the diagnosis to a spouse, or in the termination of a pregnancy in an underage patient, without the knowledge of the patient's parents. Many States in the USA have laws governing parental notification in underage abortion[2]

Beneficence

The principle of beneficence expresses the duty of health care providers to be of a benefit to the patient, as well as to take active steps to prevent and to remove harm from the patient.

Autonomy

Justice

Justice in health care is usually defined as a form of fairness,and in medicine it means that when access to health care is limited, then some fair way of allocating those scarce resources must be found. It is generally accepted that persons who are equals should qualify for equal treatment; for example, Medicare is available to all persons over the age of 65 years. This category of persons is equal with respect to their age, but says nothing about need or other factors about the persons in this category. One of the most controversial issues in modern health care is "who has the right to health care?" Most generally, as a society, do we want to provide some minimum level of health care for all citizens, regardless of ability to pay? More particularly, if scarce resources mean that only some people can be treated, how should they be chosen?

Non-maleficence

The concept of non-maleficence is embodied by the phrase, "first, do no harm," (in Latin, primum non nocere). Physicians are obliged, under medical ethics, to not prescribe medications they know to be harmful. American physicians interpret this value to exclude the practice of euthanasia, though not all concur. An example of the violation of the non-maleficence dictum was Dr Jack Kevorkian, who was convicted of second-degree homicide in Michigan in 1998 after demonstrating active euthanasia on the TV news show 60 Minutes.[3] Dr Kekorvian, who claims that he participated in at least 130 assisted suicides, was released in January 2007 after eight years in prison.

Non-maleficence is a legally definable concept. Violation of non-maleficence is the subject of medical malpractice litigation.

Double effect

Some interventions undertaken by physicians can create a positive outcome while also potentially doing harm, a combination known as the "double effect." One example of this is the use of morphine in the dying patient. Morphine can ease the pain and suffering of the patient, while simultaneously hastening the patient's demise by suppressing the respiratory drive.

Importance of communication

Many so-called "ethical conflicts" in medical ethics can be traced back to a lack of communication. Communication breakdowns between patients and their healthcare team, between family members, or between members of the medical community, can all lead to disagreements and strong feelings. These breakdowns should be remedied, and many apparently insurmountable "ethics" problems can be solved with open communication.

Ethics committees

Many times, simple communication is not enough to resolve a conflict, and a hospital ethics committee, comprised of heath care professionals, clergy, and lay people, must convene to decide a complex matter.

Cultural concerns

Cultural differences can create difficult medical ethics problems. Some cultures have spiritual or magical theories about the origins of disease, for example, and reconciling these beliefs with the tenets of Western medicine can be difficult.

Truth-telling

Some cultures do not place a great emphasis on informing the patient of the diagnosis, especially when cancer is the diagnosis. Even American culture did not emphasize truth-telling in a cancer case until the 1970's. In American medicine, the principle of informed consent takes precedence over other ethical values, and patients are usually at least asked whether they want to know the diagnosis.

Conflicts of interest

"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.

Self-referral

For example, doctors who receive income from referring patients for medical tests have been shown to refer more patients for medical tests [1]. This practice is proscribed by the American College of Physicians Ethics Manual [2].

Vendor relationships

Effect on the conduct of patient care

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 [3] with amounts arranging from $100-$20,000.[4] Studies show that doctors can be influenced by drug company inducements, including gifts and food.[5] Industry-sponsored Continuing Medical Education (CME) programs influence prescribing patterns. [6] Many patients surveyed in one study agreed that physician gifts from drug companies influence prescribing practices. [7] 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. [8]

Effect on the conduct of research and publishing

Financial relationships with pharmaceutical manufacturers are associated with authors' published positions.[9] Faculty members[10][11] and institutions[12] with entrepreneurial relationships are associated with data withholding from colleagues or publication.

Conflict of interest in research

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.[13] Worse it has been reported that some published articles use 'ghost writers'.[14] 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.[15] When reporting data from randomized controlled trials, industry-sponsored studies may be more likely to omit intention-to-treat analyses.[16] 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.[17] Alternatively, the usefulness of drugs may be overstated, although, this is contentious since one study did not find evidence of overstatement.[18] 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.[19]

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 livelyhood 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.

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.[20][21].

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 [22].

Futility

Advanced directives include living wills and durable powers of attorney for healthcare. (See also Do Not Resuscitate and cardiopulmonary resuscitation) In many cases, the "expressed wishes" of the patient are documented in these directives, and this provides a framework to guide family members and health care professionals in decisionmaking when the patient is incapacitated. Undocumented expressed wishes can also help guide decisionmaking, in the absence of advanced directives. "Substituted judgement" is the concept that a family member can give consent for treatment if the patient is unable (or unwilling) to give consent himself. The key question for the decisionmaking surrogate is not, "What would you like to do," but instead, "What do you think the patient would want in this situation." Courts have supported family's arbitrary definitions of futility to include simple biological survival, as in the Baby K case. A more in-depth discussion of futility is available at medical futility.

  • Baby Doe Law Establishes state protection for a disabled child's right to life, ensuring that this right is protected even over the wishes of parents or guardians in cases where they want to withhold treatment.


Distribution and utilization of research and care

References

  1. 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.
  2. (1998) "Ethics manual. Fourth edition. American College of Physicians". Ann Intern Med 128 (7): 576-94. PMID 9518406.
  3. 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.
  4. 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.
  5. Güldal D, Semin S (2000). "The influences of drug companies' advertising programs on physicians". Int J Health Serv 30: 585-95. PMID 11109183.
  6. Wazana A (2000). "Physicians and the pharmaceutical industry: is a gift ever just a gift?". JAMA 283: 373-80. PMID 10647801.
  7. Blake R, Early E. "Patients' attitudes about gifts to physicians from pharmaceutical companies". J Am Board Fam Pract 8: 457-64. PMID 8585404.
  8. [1] LA Times, "Drug money withdrawals: Medical schools review rules on pharmaceutical freebies," posted 2/12/07, accessed 3/6/07]
  9. 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]
  10. 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 (15): 1224–8. PMID 9103347[e]
  11. 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]
  12. 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]
  13. 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]
  14. Laine C, Mulrow CD (2005). "Exorcising ghosts and unwelcome guests". Ann Intern Med 143: 611–2. PMID 16230729[e]
  15. 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.
  16. 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.
  17. 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.
  18. 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]
  19. 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.
  20. 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.
  21. 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.
  22. Gartrell N et al. (1992). "Physician-patient sexual contact. Prevalence and problems". West J Med 157: 139-43. PMID 1441462.