Final Flashcards
How does research go wrong
1.) consent
2.) risk/benefit ratio
3.) subject selection
4.) scientific merit
5.) money
Peter Buston
Tuskegee Syphilis whistleblower
Declaration of Helsinki
stating control groups should receive current treatment unless there is none or if there will be no irreversible harm done.
the National Research Act
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was created by the National Research Act and wrote The Belmont Report.
Belmont report
This serves as a code of ethics for research involving human subjects and the framework for US regulations to protect human subjects
The common rule
The Common Rule includes the requirement for an Institutional Review Board (IRB) process to review the informed consent process, the balance of risks and benefits, and the equitable selection of subjects.
Equipoise
a state of uncertainty on the part of the clinical observer towards a treatment. One cannot know a treatment is superior.
This can be disturbed before a clinical trial begins. Furthermore, it cannot be maintained while results reveal differences in ongoing treatment.
Theoretical equipoise
a perfect 50/50 divide between the effectiveness of both treatments is maintained
If the researcher suspects one treatment could possibly be better this is compromised. Forces operation in one-dimensional hypothesis that clinical trials don’t operate in.
Clinical equipoise:
Professional disagreement among colleagues regarding a treatment that warrants an investigation
Only requires the acknowledgment that one person’s less favored treatment is another’s preferred.
076 treatment
otherwise known as long course AZT treatment. A pregnant HIV-positive woman received AZT orally 5 times a day starting around 14-34 weeks into her pregnancy. The infant then received AZT orally 4 times a day for 6 weeks. A study was created to test short term AZT treatment for women in Sub-Saharan Africa who could not access this treatment
Dan Markingson
a mentally ill man who committed suicide in 2004 while testing the antipsychotic drug Quetiapine. Dan was admitted to Fairview University Medical Center- a teaching hospital for the U of M.
Dr.Olson
Olson created this treatment and was payed on how many subjects he enrolled in the study.
Cafe study
what Dan Markingson was enrolled in
Compassionate use
Procedure got around IRB by innovative therapies. This is where procedures are designed wholly for the patient’s benefit. Macchiarini claimed compassionate use in the US. This allows terminal patients with no other options to access experimental drugs or procedures.
Medical futility
If the last 100 cases of a medical treatment failed it is deemed futile meaning it cannot end dependence on intensive care or just preserve the state of unconscious.
Baby L
2 year old girl born at 46 weeks and weakened by mechanical ventilation. Her only neurological capability was a response to pain. She was repeatedly hospitalized for pneumonia, sepsis, and cardiopulmonary arrests. Doctors went against the mother’s orders and believed treatment wasn’t in the child’s best interest because she could only experience pain. The child was stabilized without a ventilator and doctors refused to participate in a court ordered ventilation.
Baby K
Child was born in an anencephalic state (they only had a brainstem)
.Normal care is hydration, nutrition, and comfort because ventilation, surgery, or drugs are seen as pointless. Baby K’s mother wanted extraordinary care at the denial of care team. The court ruled with the mother stating the child must be placed on a ventilator.
Best interest of patient
relief of suffering, preservation/restoration of functioning, quality, and extent of life sustained
Bayh-Dole Act 1980
permits universities to patent discoveries and license to companies for profit. Companies sponsor trials of drugs going out of patent to replace the drugs
The Prescription Drug User Fee Act (PDUFA)
allows the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the drug approval process and speed it up
Cosmetic psychopharmacology
diagnostic bracket creep
Meaning behind Prozac’s name
Pro- is meant to signify profession. And AC- activity. Made powerful by the Z.
John Pesando
the hutch protocol 126 whistleblower
Sarafem
prozac repackaged with a feminine packaging. Meant to treat PMDD or other issues.
Protocol 126
Protocol 126 enrolled bone marrow transplant patients to avoid bone marrow rejection. Patients would die of graft failure. Often picked patients that would have had a successful procedure without protocol 126.
Bob Helms
created the jobzine Guinea Pig Zero to give reviews to trial sites and attempt to connect fellow guinea pigs. Unfortunately, due to the nature of the lifestyle, they are very hard to unionize so labor protection are lacking.
Seattle god committee
established in the 1960s to make decisions about who would receive life-saving dialysis treatments.
decision making hierarchy
1.) competent adult making their own decisions 2.) advance directive 3.) substitute judgement (parent/spouse/other) 4.) best interest standard.
Karen Ann Quinlan
. In 1975 Quinlan collapsed after mixing drugs and alcohol and entered persistent vegetative state. The doctors determined she had little chance of recovery due to a lack of brain activity. She still remained on life support at the request of her parents. Later, her parents requested to take her off of life support as she wouldn’t have wanted to live without consciousness. Doctors were hesitant since she did not have an advance directive. In 1976 they sought legal action where the NJ Supreme Court ruled in favor of her parents. Her ventilator was removed and she continued to live for a decade before passing in 1985.
Terri Schiavo
Terri Schiavo suffered a cardiac arrest due to a potassium imbalance, leading to brain damage. She was diagnosed as being in a persistent vegetative state with no hope of recovering. Terri’s husband and her parents disagreed on whether or not she should be kept alive. Her husband claimed that past conversations indicated that she would not want to live that life, but her parents claimed that she could still recover with therapy and should be kept alive. There was a long legal battle that eventually resulted in her feeding tube being removed in 2005.
Wim Distelmans
involved in the right to die movement and supported euthanasia for patients with incurable illness and extreme mental or physical suffering.
experiential vs critical interests
Experiential interests are things that we just enjoy doing, where critical interests are more big picture and focus on meaning. They should be valuated differently
Baby M
Mary Beth Whitehead agreed to be artificially inseminated with William Stern’s sperm, carry the child, and relinquish custody to the Sterns in exchange for $10,000. After giving birth in 1986, Whitehead changed her mind and refused to give up the baby (named Melissa by the Sterns and Sara by Whitehead). Whitehead fled with the child, prompting a legal battle. The legal battle went to the NJ supreme court in 1988, where they decided that the surrogacy contract was not legally binding and gave parental rights to Whitehead with William holding custody. This led to many states banning commercial surrogacy.
