170. Ethics

170.986 Stem Cells

 

The Colorado Medical Society (CMS) supports ensuring proper care of patients using stem cell treatments. This policy is based upon guidelines by the Federation of State Medical Boards.

• Published research should be used to guide decision making and support claims
• Patients require expanded informed consent
• Marketing materials must be accurate
• FDA actions should be monitored by state boards
• Physicians must be appropriately trained
• Physicians must avoid making promises about uncertain or unrealistic outcomes
• Excessive fees should be avoided

(Adopted, BOD, 7/2018)

170.987 Health Care as a Fundamental Societal Obligation

 

CMS formally recognizes that every member of society deserves an adequate level of protection from illness and avoidable pain and suffering related to health problems and that this fundamental societal obligation is derived from the sum of the diverse ethical considerations of our values of equality of opportunity, justice and compassion.
(RES-3, AM 2007; Reaffirmed, BOD-1, AM 2014)

170.988 Stem Cell Research

 

The Colorado Medical Society (CMS) supports stem cell research conducted within appropriate ethical guidelines. CMS opposes federal funding restrictions on stem cell research conducted according to ethical guidelines established by the medical community.
(RES-10, AM 2006; Reaffirmed, BOD-1, AM 2014)

170.989 Code of Medical Ethics

 

The Colorado Medical Society (CMS) House of Delegates authorizes the Council on Ethical and Judicial Affairs to recommend changes in the CMS Bylaws and/or the CMS Policy Manual to reflect adoption of the American Medical Association Code of Medical Ethics as the CMS Code of Medical Ethics except where CMS has adopted independent opinions.
(RES-17, AM 2002; Reaffirmed, BOD-1, AM 2014)

170.990 Patenting Human Genes

 

A patent grants the holder the right, for a limited amount of time, to prevent others from commercializing his or her inventions. At the same time, the patent system is designed to foster information sharing. Full disclosure of the invention-enabling another trained in the art to replicate it-is necessary to obtain a patent. Patenting is also thought to encourage private investment into research. Arguments have been made that the patenting of human genomic material sets a troubling precedent for the ownership or commodification of human life. DNA sequences, however, are not tantamount to human life, and it is unclear where and whether qualities uniquely human are found in genetic material.

Genetic research holds great potential for achieving new medical therapies. It remains unclear what role patenting will play in ensuring such development. At this time the American Medical Association Council on Ethical and Judicial Affairs concludes that granting patent protection should not hinder the goal of developing new beneficial technology and offers the following guidelines:

Patents on processes-for example, processes used to isolate and purify gene sequences, genes, and proteins, or vehicles of gene therapy-do not raise the same ethical problems as patents on the substances themselves and are thus preferable.

Substance patents on purified proteins present fewer ethical problems than patents on genes or DNA sequences and are thus preferable.

Patent descriptions should be carefully constructed to ensure that the patent holder does not limit the use of a naturally occurring form of the substance in question. This includes patents on proteins, genes, and genetic sequences.

One of the goals of genetic research is to achieve better medical treatments and technologies. Granting patent protection should not hinder this goal.

Individuals or entities holding patents on genetic material should not allow patients to languish and should negotiate and structure licensing agreements in such a way as to encourage the development of better medical technology.
(RES-13, AM 2002; Reaffirmed, BOD-1, AM 2014)

170.991 Gene Therapy

 

Gene therapy involves the replacement or modification of a genetic variant to restore or enhance cellular function or to improve the reaction of non-genetic therapies.

Two types of gene therapy have been identified: (1) somatic cell therapy, in which human cells other than germ cells are genetically altered, and (2) germ line therapy, in which a replacement gene is integrated into the genome of human gametes or their precursors, resulting in expression of the new gene in the patient’s offspring and subsequent generations. The fundamental difference between germ line therapy and somatic cell therapy is that germ line therapy affects the welfare of subsequent generations and may be associated with increased risk and the potential for unpredictable and irreversible results. Because of the far-reaching implications of germ line therapy, it is appropriate to limit genetic intervention to somatic cells at this time.

The goal of both somatic cell and germ line therapy is to alleviate human suffering and disease by remedying disorders for which available therapies are not satisfactory. This goal should be pursued only within the ethical tradition of medicine, which gives primacy to the welfare of the patient whose safety and well-being must be vigorously protected. To the extent possible, experience with animal studies must be sufficient to assure the effectiveness and safety of the techniques used, and the predictability of the results.

Moreover, genetic manipulation generally should be utilized only for therapeutic purposes. Efforts to enhance “desirable” characteristics through the insertion of a modified or additional gene, or efforts to “improve” complex human traits “eugenic development of offspring” are contrary not only to the ethical tradition of medicine, but also to the egalitarian values of our society. Because of the potential for abuse, genetic manipulation to affect non-disease traits may never be acceptable and perhaps should never be pursued. If it is ever allowed, at least three conditions would have to be met before it could be deemed ethically acceptable: (1) there would have to be a clear and meaningful benefit to the person, (2) there would have to be no trade-off with other characteristics or traits, and (3) all citizens would have to have equal access to the genetic technology, irrespective of income or other socioeconomic characteristics. These criteria should be viewed as a minimal, not an exhaustive, test of the ethical propriety of non-disease-related genetic intervention. As genetic technology and knowledge of the human genome develop further, additional guidelines may be required.

As gene therapy becomes feasible for a variety of human disorders, there are several practical factors to consider to ensure safe application of this technology in society. First, any gene therapy research should meet the Council’s guidelines on clinical investigation (Opinion 2.07) and investigators must adhere to the standards of medical practice and professional responsibility. The proposed procedure must be fully discussed with the patient and the written informed consent of the patient or the patient’s legal representative must be voluntary.

Investigators must be thorough in their attempts to eliminate any unwanted viral agents from the viral vector containing the corrective gene. The potential for adverse effects of the viral delivery system must be disclosed to the patient. The effectiveness of gene therapy must evaluated fully, including the determination of the natural history of the disease and follow-up examination of subsequent generations. Gene therapy should be pursued only after the availability or effectiveness of other possible therapies is found to be insufficient. These considerations should be reviewed, as appropriate, as procedures and scientific information develop.
(RES-14, AM 2002; Reaffirmed, BOD-1, AM 2014)

170.992 Human Cloning

 

“Somatic cell nuclear transfer” is the process in which the nucleus of a somatic cell of an organism is transferred into an enucleated oocyte. “Human cloning” is the application of somatic nuclear transfer technology to the creation of a human being that shares all of its nuclear genes with the person donating the implanted nucleus.

In order to clarify the many existing misconceptions about human cloning, physicians should help educate the public about the intrinsic limits of human cloning as well as the current ethical and legal protections that would prevent abuses of human cloning. These include the following:

1. Using human cloning as an approach to terminal illness or mortality is a concept based on the mistaken notion that one’s genotype largely determines one’s individuality. A clone-child created via human cloning would not be identical to his or her clone-parent.
2. Current ethical and legal standards hold that under no circumstances should human cloning occur without an individual’s permission.
3. Current ethical and legal standards hold that a human clone would be entitled to the same rights, freedoms, and protections as every other individual in society. The fact that a human clone’s nuclear genes would derive from a single individual rather than two parents would not change his or her moral standing.

Physicians have an ethical obligation to consider the harms and benefits of new medical procedures and technologies. Physicians should not participate in human cloning at this time because further investigation and discussion regarding the harms and benefits of human cloning are required. Concerns include:

1. Unknown physical harms introduced by cloning. Somatic cell nuclear transfer has not yet been refined and its long-term safety has not yet been proven. The risk of producing individuals with genetic anomalies gives rise to an obligation to seek better understanding of and potential medical therapies for the unforeseen medical consequences that could stem from human cloning.
2. Psychosocial harms introduced from cloning, including violations of privacy and autonomy. Human cloning risks limiting, at least psychologically, the seemingly unlimited potential of new human beings and thus creating enormous pressures on the clone-child to live up to expectations based on the life of the clone-parent.
3. The impact of human cloning on familial and societal relations. The family unit may be altered with the introduction of cloning, and more thought is required on a societal level regarding how to construct familial relations.
4. Potential effects on the gene pool. Like other interventions that can change individuals reproductive patterns and the resulting genetic characteristics of a population, human cloning has the potential to be used in a eugenic or discriminatory fashion-practices that are incompatible with the ethical norms of medical practice. Moreover, human cloning could alter irreversibly the gene pool and exacerbate genetic problems that arise from deleterious genetic mutations, resulting in harms to future generations.

Two potentially realistic and possibly appropriate medical uses of human cloning are for assisting individuals or couples to reproduce and for the generation of tissues when the donor is not harmed or sacrificed. Given the unresolved issues regarding cloning identified above, the medical profession should not undertake human cloning at this time and pursue alternative approaches that raise fewer ethical concerns.

Because cloning technology is not limited to the United States, physicians should help establish international guidelines governing human cloning.
(RES-16, AM 2002; Reaffirmed, BOD-1, AM 2014)

170.993 Genetic Testing by Employers

 

As a result of the human genome project, physicians will be able to identify a greater number of genetic risks of disease. Among the potential uses of the tests that detect these risks will be screening of potential workers by employers. Employers may want to exclude workers with certain genetic risks from the workplace because these workers may become disabled prematurely, impose higher health care costs, or pose a risk to public safety. In addition, exposure to certain substances in the workplace may increase the likelihood that a disease will develop in the worker with a genetic risk for the disease.

1. It would generally be inappropriate to exclude workers with genetic risks of disease from the workplace because of their risk. Genetic tests alone do not have sufficient predictive value to be relied upon as a basis for excluding workers. Consequently, use of the tests would result in unfair discrimination against individuals who have positive test results. In addition, there are other ways for employers to serve their legitimate interests. Tests of a worker’s actual capacity to meet the demands of the job can be used to ensure future employability and protect the public’s safety. Routine monitoring of a worker’s exposure can be used to protect workers who have a genetic susceptibility to injury from a substance in the workplace. In addition, employees should be advised of the risks of injury to which they are being exposed.
2. There may be a role for genetic testing in the exclusion from the workplace of workers who have a genetic susceptibility to injury. At a minimum, several conditions would have to be met:
1. The disease develops so rapidly that serious and irreversible injury would occur before monitoring of either the worker’s exposure to the toxic substance or the worker’s health status could be effective in preventing the harm.
2. The genetic testing is highly accurate, with sufficient sensitivity and specificity to minimize the risk of false negative and false positive test results.
3. Empirical data demonstrate that the genetic abnormality results in an unusually elevated susceptibility to occupational injury.
4. It would require undue cost to protect susceptible employees by lowering the level of the toxic substance in the workplace. The costs of lowering the level of the substance must be extraordinary relative to the employer’s other costs of making the product for which the toxic substance is used. Since genetic testing with exclusion of susceptible employees is the alternative to cleaning up the workplace, the cost of lowering the level of the substance must also be extraordinary relative to the costs of using genetic testing.
5. Testing must not be performed without the informed consent of the employee or applicant for employment.

(RES-15, AM 2002; Reaffirmed, BOD-1, AM 2014)

170.994 Euthanasia and Physician-Assisted Death

 

“Euthanasia” contains the Greek words “eu” + “thanatos” (death) which means an easy death. Only the competent patient or the authentic proxy of the incompetent patient may decide what for each patient constitutes a good death.

Medical interventions may be withheld or withdrawn, allowing a disease process to continue its natural course leading to death. Competent patients have a moral right to seek a good death by refusing treatment if that is their wish. Furthermore, physicians have a moral obligation to honor the wishes of their competent patients or the authentic proxy of their incompetent patients, with respect to withholding and withdrawing undesired medical interventions.

“Euthanasia” has been used to describe a process in which an intervention by someone other than the patient is intended directly and immediately to bring about the death of a suffering patient at the patient’s request. Euthanasia is not permitted in the United States. Because it often involves a patient who cannot provide active participation or may not be capable of making an informed decision at the time, it remains an ethical barrier to physician participation.

Physician assisted death is defined as providing a terminal patient, who is capable of making an informed and independent medical decision, with the means of a medication that the patient can self-administer with the intent of causing death.

Withdrawal of medication or other life-sustaining treatment is not considered euthanasia. Providing treatment or medication with the intention of easing the pain of a dying patient is acceptable treatment and not euthanasia, even though such treatment or medication may foreseeably hasten the moment of death.

PHYSICIAN-ASSISTED DEATH

• It is incumbent upon the medical profession to use all means to ensure that dying patients are provided optimal treatment for their pain and other discomfort. This may include the use of more aggressive comfort care measures, including greater reliance on palliative and hospice care, which can alleviate the physical and emotional suffering that dying patients experience.
• Physicians should recognize the physical, social and existential needs of patients with terminal illness. Involvement of palliative care at early stages of serious life-threatening illness or injury can allow patients and their support system adequate time and information to anticipate choices in care when/if the condition becomes terminal. Emotional suffering should also be addressed by health care professionals with expertise in the psychiatric aspects of terminal illness.
 
• Every effort should be made to encourage advance care planning for patients and their families or support systems prior to disease progression.
• Requests for physician-assisted death may be a signal to the physician that the patient’s needs are unmet and further evaluation to identify the elements contributing to the patient’s suffering is necessary. Multidisciplinary intervention, including specialty consultation, pastoral care, family counseling and other modalities should be sought as clinically indicated.
• Further efforts to educate physicians about advanced pain management techniques, both at the undergraduate and graduate levels, are necessary to overcome any shortcomings in this area. Physicians should recognize that courts and regulatory bodies readily distinguish between use of narcotic drugs to relieve pain in dying patients and use in other situations.
• The principle of patient autonomy requires that physicians must respect the decision to forego life-sustaining treatment of a patient who possesses decision-making capacity. Life-sustaining treatment is any medical treatment that serves to prolong life without reversing the underlying medical condition. Life-sustaining treatment includes, but is not limited to, mechanical ventilation, renal dialysis, chemotherapy, antibiotics and artificial nutrition and hydration.
• The professional and societal risks of involving physicians in medical interventions intended to cause patients’ deaths are too great to condone euthanasia. Physicians have an obligation to relieve pain and suffering and to promote the dignity and autonomy of dying patients in their care. This includes providing effective palliative treatment including decisions regarding refusing or withdrawing care.
• In those instances where state law or precedent permits physicians to assist terminal patients to self administer a lethal dose of medication with the intention of physician-assisted death: (1) Physicians and patients should be allowed to pursue options that do not violate either party’s fundamental values; and (2) Adequate protections must be in place to protect both physicians and patients, including but not limited to:
  1. Qualifications of a patient who can participate:
     • Adult, age 18 or older
     • Has the capacity to make medical decisions: able to understand their own condition, articulate their values, weigh risk and benefits
     • Has a confirmed terminal disease that is likely to result in death in 6 months
     • Is a resident of Colorado
     • Makes a voluntary request for aid in dying
     • Has had all feasible end-of-life services, including pain control, palliative care, comfort care and hospice
     • Must be able to self-administer lethal medication
     • Cannot take medication in a public place

  2. Medical Requirements

     • Physician must have the qualified patient request aid in dying directly and in writing.
     • Waiting period between requests.
     • Cannot accept a request through an advanced directive, a power of attorney or other proxy.
     • Must obtain a confirming second opinion on diagnosis of terminal disease and capacity of patient to make a medical decision.
     • Refer for counseling if patient is depressed or has mental health issues that may affect judgment (or requirement for mental health evaluation).
     • Must discuss and document all options for end-of life care, risks /results of taking lethal medication.
     • At the time of prescribing, must document that patient is making an informed decision and that the decision can be rescinded at any time.

  3. Reporting and documentation requirements

     • All discussions, consultations and prescriptions must be part of the patient’s medical record.
     • Physician’s duty to report to specified agency prescription for aid in dying, patient demographics, disease diagnosis, and insurance.
     • Yearly aggregated reports. Individual confidentiality.
     • Prescriptions identified as aid-in-dying medication.

  4. Other

     • Fraud protections: penalties for altering, forging prescriptions or suppressing rescissions.
     • Penalties for coercion from individuals, facilities or insurers to seek aid-in-dying medication.
     • Civil and other immunity for physicians who write prescriptions or who choose not to participate.
     • Requirements for witnesses to written request: must not be the patient’s provider; one cannot be related or a beneficiary.
     • Safe storage of prescribed medication and requirement of return of unused medication.
     • Prohibition of euthanasia.
     • Encourage family notification.

(Adopted by the board of directors, Sept. 16, 2016)

170.995 Grievance Reviews

 

The Colorado Medical Society (CMS) Grievance Review Committee and all component society grievance review committees and the members of each of these committees individually and as a group are authorized by the CMS Board of Directors to conduct reviews on behalf of the CMS and its members.
(Motion of the Board, February 1998; Reaffirmed, BOD-1, AM 2014)

170.996 The Physician-Patient Covenant

 

Patient-Physician Covenant - Medicine is, at its center, a moral enterprise grounded in a covenant of trust. This covenant obliges physicians to be competent and to use their competence in the patient’s best interests. Physicians, therefore, are both intellectually and morally obliged to act as advocates for the sick wherever their welfare is threatened and for their health at all times.

Today, this covenant of trust is significantly threatened. From within, there is growing legitimation of the physician’s materialistic self-interest; from without, for-profit forces press the physician into the role of commercial agent to enhance the profitability of health care organizations. Such distortions of the physician’s responsibility degrade the physician-patient relationship that is the central element and structure of clinical care. To capitulate to these alterations of the trust relationship is to significantly alter the physician’s role as healer, care giver, helper, and advocate for the sick and for the health of all.

By its traditions and very nature, medicine is a special kind of human activity-one that cannot be pursued effectively without the virtues of humility, honesty, intellectual integrity, compassion, and effacement of excessive self-interest. These traits mark physicians as members of a moral community dedicated to something other than its own self-interest.

Our first obligation must be to serve the good of those persons who seek our help and trust us to provide it. Physicians, as physicians, are not, and must never be, commercial entrepreneurs, gateclosers, or agents of fiscal policy that runs counter to our trust. Any defection from primacy of the patient’s well being places the patient at risk by treatment that may compromise quality of or access to medical care.

We believe the medical profession must reaffirm the primacy of its obligation to the patient through national, state, and local professional societies; our academic, research, and hospital organizations; and especially through personal behavior. As advocates for the promotion of health and support of the sick, we are called upon to discuss, defend, and promulgate medical care by every ethical means available. Only by caring and advocating for the patient can the integrity of our profession be affirmed. Thus we honor our covenant of trust with patients.
(RES-11, IM 1996; Reaffirmed, BOD-1, AM 2014)

170.997 Corporate Practice of Medicine

 

Recognizing the legislative changes regarding the corporate practice of medicine, the Colorado Medical Society supports adherence to the following ethical and legal guidelines, which apply to any type of practice arrangement:

1. Physicians must use their best efforts and skills in the care of patients and must be ever wary of those forces in society that can erode ethical medical practice.
2. The welfare of patients lies above the financial interest of the physician or of any hiring or contracting entity.
3. Clinical decision making must remain in the hands of the physician.
4. Physicians must not deny their patients’ access to appropriate medical services based upon the promise of personal financial reward or the avoidance of financial penalties.
5. No entity that employs or contracts with physicians to provide medical care may offer these physicians any percentage of fees charged to patients for referred services provided by this entity or any other financial incentive to artificially increase services provided to patients.
6. The bylaws of any hospital which employs or contracts with community based physicians shall not discriminate with regard to credentials or staff privileges on the basis of whether a physician is an employee of, or a contracting physician with, the hospital.
7. Hospitals that employ or contract with physicians may not limit hospital-based referrals exclusively to those physicians whom they employ or with whom they contract if such a limitation on referrals compromises patient care.

(RES-46, AM 1994; Reaffirmed, BOD-1, AM 2014)

170.998 Sexual Misconduct

 

The Colorado Medical Society supports the American Medical Association Principles of Medical Ethics and the Colorado Medical Board’s Policy regarding sexual misconduct by physicians.
(Motion of the Board, July 1994; Revised, BOD-1, AM 2014)

170.999 Obligation to Report Impaired, Incompetent or Unethical Colleagues

 

1. Impairment
1. Impairment should be reported to the hospital’s in-house impairment program, if available. If no in-house program is available, or if the type of impairment is not normally addressed by an impairment program, e.g., extreme fatigue and emotional distress, then the chief of an appropriate clinical service, the chief of staff of the hospital, or other appropriate supervisor (e.g., the chief resident) should be alerted.
2. If a report cannot be made through the usual hospital channels, then a report should be made to an external impaired physician program. The local medical societies or state licensing boards typically would operate such programs.
3. Physicians in office-based practices who do not have clinical privileges at an area hospital should be reported directly to an impaired physician program.
4. If reporting to an individual or program that would facilitate the entrance of the impaired physician into an impaired physician program cannot be accomplished, then the impaired physician should be reported directly to the state licensing board.

 

2. Incompetence
1. Initial reports of incompetence should be made to the appropriate clinical authority who would be empowered to assess the potential impact on patient welfare and to facilitate remedial action, e.g., the chief resident, the chief of an appropriate clinical service, the chief of the hospital staff, or the medical director of a group medical practice.
2. The individual who receives a report of incompetence should, in turn, notify the hospital peer review body where appropriate. Physicians who receive reports of incompetence have an ethical duty to critically and objectively evaluate the reported information and to assure that identified deficiencies are either remedied or further reported to the state licensing board.
3. Instances of incompetence by physicians who have no hospital affiliation should be reported to the local or state medical society.
4. Continued behavior that is potentially injurious to patients must further be reported to the state licensing board.
5. If the incompetence is of a sufficiently serious nature as to pose an immediate threat to the health of the physician’s patients, then it should be reported directly to the state licensing board.

 

3. Unethical Conduct – Unethical behavior (which does not fit into the category of either incompetence or impairment) should be reported in accordance with these guidelines:
1. Unethical conduct that threatens patient care or welfare should be reported to the appropriate authority for a particular clinical service, i.e., the chief resident, the chief of an appropriate clinical service, or the chief of the hospital staff.
2. Unethical behavior, which violates the provisions of the state licensing board, should be reported to the state licensing board.
3. Unethical conduct, which violates criminal statutes, should be reported to the appropriate law enforcement authorities.
4. Examples of unethical conduct which to not fall into the above three categories, or unethical conduct, which has not been addressed through other channels, should be reported to the local or state medical society.

 

4. Where the impairment, incompetence, or unethical behavior of a physician continues despite the initial report(s), the reporting physician should report to a higher or additional authority. To aid physicians who report inappropriate behavior of colleagues in carrying out this obligation, the person or body receiving the initial report should notify the reporting physician when appropriate action has been taken.

 

5. Physicians should work to assure that state laws provide immunity to those who report impaired, incompetent, or unethical colleagues.

 

6. In certain circumstances, an anonymous report may be the only practical method of alerting an authoritative body to a colleague’s misconduct. Anonymous reports of misconduct should receive appropriate review and confidential investigation by authorities.

 

7. Principles of due process must be observed in the conduct of all disciplinary matters involving physician participants at all levels. However, the confidentiality of the reporting physician should be maintained to the greatest extent possible within the constraints of due process, in order to minimize potential professional recriminations.

 

8. The medical profession as a whole must combat the perception that physicians are not adequately protecting the public from incompetent, impaired, or unethical physicians by better communicating its efforts and initiatives at maintaining high ethical standards and quality assurance.

(RES-37, IM 1992; Reaffirmed, BOD-1, AM 2014)