Bioethics

• Tuskegee Historical Phase II (1936-1965


  -offered 'special treatment' which was really a spinal tap for 'bad blood' -was to determine if syphilis had spread into their nervous system -AUTHORIZED the spinal taps but informed consent not met-intentionally deceived the patients into thinking it was treatment not research-40's penicillin became standard treatment but treatment withheld even into the 70's -medical students rotated in through the unit during that timeframe
• Tuskegee Syphillis StudyHistorical Phase I (1932-1936)

  -philanthropic project to diagnose and treat black men in Alabama who had syphillis-AB's were unknown at the time -US Public Health Service-set up the study to document the natural history of syphilis
• Research protocol is ethical only if...(7 things)

  1. Scientifically valid2. Uses fair subject selection3. Favourable benefit/harm ratio4. Dignity for persons5. Informed Consent6. Voluntariness of participants7. Undergoes Ethical Review
• IRB's


  aka. Local research ethics Committees, Research Ethics Boards-weight the utility of each protocol and approve them when the benefits outweigh associated risks
• Belmont Report


  -commissioned and adopted in the IS in the 70's after the Tuskegee study new broke-basis of laws that protect subjects of research-req's informed consent, AND mandates the review of potential risks and benefits to participants by impartial committees called Institutional Review Boards (IRB's)
• Nuremburg Code


  this was adopted in 1949 b/c of deadly experiments of the Nazis on unwilling human subjects -"the voluntary consent of the human subject is absolutely essential...must make an understanding and enlightened decision." (informed consent)
• Declaration of Helsinki


  states that 'the well-being of the human subject should take precedence over the interests of science and society'-produced by the WMA which was formed in 1947
• Equipoise (balance of interests)


  -genuine uncertainty about which arm of a clinical trial will provide the most benefits or harms to pts. research subjects or future pts. -particularly difficult to attain for physicians whose pts. are their research subjects
• Experimental or innovative Therapy


  there is uncertainty that the patients enrolled as research subjects will obtain any therapeutic effect
• Standard of Care


  refers to a treatment or procedure that is routinely administered for a given condition because it is known to be effective-Contrasts with Experimental or innovative Therapy
• Clinical Trials: Phase 4

  -post marketing studies wherein data is sought from clinicians -delineates doctor satisfaction with outcomes of using the new treatment -in the US there is evidence that phase 4 studies are not conducted with scientific rigour and that possible side effects and adverse events do not lead to reviews, warnings or recalls as soon as they should.
• Clinical Trials: Phase 3


  tests on large group of ppl (1000-3000) to confirm effectiveness, monitor side effects, compare to other treatments, and determine what constitutes safe and appropriate use-in the US approval from the FDA is usually sought after phase 3 success
• Clinical Trials: Phase 2


  testing the safe dosage range among a larger group (100-300) to examine efficacy and further evaluate safety
• Clinical trials: Phase 1


  tests a new drug or treatment for the first time on a sm. group (20-80) ppl to evaluate overall safety and determine safe dosage range, toxicity, and side effects
• Therapeutic Misrepresentation

  IMPLYING that a drug or treatment is efficacious knowing that it has not conclusively been proven to be so
• Therapeutic Misconception


  BELIEF that a drug or treatment is efficacious when it has not been conclusively proven to be so
• research participants


  -accept risks in the hopes that doing so will benefit themselves and/or others-People choose to participate in research for varied reasons. Prisoners have the right to serve as research participants
• goals of clinical practice

  -to help the pt.
• Goal of medical research

  to gain information that will inform the medical profession about how to improve RXNs-improve care of future pts. -conflicts with the goals of clinical practice-Done to remove uncertainty about current RXNs not always to improve existing treatments
• Dr. Kevorkian


  advocates to legalize PAS-lost his license and was imprisoned after a videotape broadcast on CBS 60 minutes documented him providing PAS-released in 2007
• AMA's view on PAS

  fundamentally incompatible with a physician's role as a healer-physicians must aggressively respond to the needs of patients at the end of life
• Withholding and/or withdrawing artificial life support


  is both ethical and legal but uncertainty and conflicts persist because people disagree about what constitutes improvement or benefit. Does NOT constitute PAS, euthanasia or terminal sedation
• Euthanasia


  is when a doctor kills a pt. through lethal injection or other means for whatever reason
• PAS


  when the doctor prescribes medications that a patient can end their own life when a pt. chooses. -A response to a pt. request autonomy and agency-It does not accord specifically with any one theory-If The patient has become depressed to the extent that this may be affecting decision making, psychiatric evaluation is needed, clinical practice standards require you to seek psychiatric evaluation and ensure that the patient has mental capacity before proceeding further
• Bias


  Impedes the ability to access and assess credibility and relevance of information
• Physician's obligations to society arise from...

  societal trust
• Oregon Death with Dignity Act

  -OR. resident-At least 18 yrs old -2 oral requests separated by 15 days-Signed written request-2 confirm diagnosis, prognosis, capacity-prescribing doc inform pt. of alternatives-report all RXNs to DHS
• Bioethical Questions: One approach to work through any problem


  -Who has legitimate interest in the outcome? -What actions might you take? -What are the consequences? (probabilities, severities) -What are you obligations? -What other ethical concerns are involved?
• Percival's code of 1803

  -Honour bound to help-the moral authority and independence of physicians in service to others -profession's responsibility to care for the sick, and emphasized individual honour
• The 3 duties according to the WMA code of ethics

  1. Duties of physicians-independent judgement -maintain highest standards of conduct -report unethical or incompetent colleagues2. Duties of physicians to patients -not enter into sexual relationship with a current patient or into any abusive or exploitative relationship3. Duties of physicians to colleagues-communicate effectively
• AMA Opinion on Capital Punishment


  -An individual's opinion is a personal moral decision-a physician as a member of a profession dedicated to preserving life when there is hope of doing so should not be a participant in legally authorized execution -organ donation only permissible if decision to donate was made before the prisoner's conviction
• Professional Rights and Responsibilities according to the AMA code of medical ethics

  -Reporting adverse drug/Device Events -an obligation to communicate to the broader medical community -spontaneous reports of adverse events are irreplaceable source of valuable info -certainty or even reasonable likelihood of a causal relationship will rarely exist and is NOT req'd before reporting
• AMA Code of Medical Ethics

  -council on ethical and judicial affairs
• Professional Deficits

  -physicians should be monitored for: -criminal record, drug abuse, aggressive behaviour, etc. all unprofessional behaviours
• Video: Cameron's Arc


  Tay Sach's Disease.-recognize certain 'carepoints' as an unmet need being recognized-Differences between effective treatment and treatment goals -creates deeper connection between doctor/patient relationship
• Physician Health Program

  Diversion programs to prevent board action
• Substance Abuse (from guest lecture)

  Maladaptive pattern of substance use leading to impairment of : 1. Role Failure 2. Risky situations 3. Run-ins with law 4. Relationship problems Work quality is often the last to go
• Features of Alcoholism

  -craving-loss of control (not being able to stop once you start) -physical dependence-tolerance- the need for greater amounts to get the same feeling
• Professionalism and Substance Abuse; Guest Lecture

  12.5% of world wide deaths = substance abuse -
• Conflict Resolution and medical students


  speaking up in a constructive, non-threatening way generates discussion and promotes resolution. Constitutes Aristotle's process of developing virtue through experience.