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49 Cards in this Set

  • Front
  • Back
Manhattan Project
"Big Science", institutional organization of science in the service of the Cold War national security
Scientific responsibility and the ethic of vocation: Oppenheimer, Teller, Wilson
Role of science in society "the military industrial complex"
Began in 1939 when Einstein wrote a letter to Roosevelt warning that Nazi Germany might be trying to develop an atomic bomb. Employed 130,000 people, $2 billion, 3 primary sites: Oak Ridge, Hanford, Los Alamos
Government set up secret cities in desert, Oppenheimer led project
Were the physicists who worked on the project responsible for the damage the a-bomb caused?
Robert Oppenheimer
Led Manhattan Project
Said that scientists can't be responsible for their discoveries, and they need to have a more modest role of only worrying about the integrity and vigor of their science
In the end, after the usage of the bomb Not the only physicist from Los Alamos that ended up feeling guilty for the end results of the atomic bomb
On a government committee debating whether the US should try and build a hydrogen bomb. He is against it because of moral grounds, cost, and no need for this much power
Kicked off the committee and no longer working for the government, booted from top physicists circles because they felt he overstepped his boundary, that his job was just to tell the gov. if the bomb was possible to build
Security clearance removed
Edward Teller
On Hydrogen Bomb "Scientist's job is to find the ways in which these laws can serve human will. Not his job to decide whether the bomb should be used or constructed. This is up to the American people and their elected representatives.
Played a big part in constructing the hydrogen bomb.
One of the main physicists to help boot Oppenheimer from committee and government circles
Get agreements between all nations to share research and cooperate in discovering the new field of nuclear energy
Duty of scientists to continue their work because of Soviet threat
Another physicist asked him to explore alternatives to dropping atomic bombs on citizens in Japan, he did not do so
Hydrogen Bomb
Advocates led by Edward Teller, Robert Oppenheimer, the leader of the Manhattan Project, opposed
Question of if US created this bomb would other countries follow? If US didn't, would other countries follow their example?
Public Critiques: Harmful to human health, may exterminate us
Debate over what the scientists role is, should they have a say in how their discoveries are used? Is it up to them to make ethical decisions?
US successfully developed h-bomb, first test in 1954, 3-4 X bigger than scientists had expected (originally had thought 1,000X bigger than a-bomb)
Big Science
Most research tied to military
Large scale organization
Interdisciplinary, project-oriented
Unlimited resources, limited time frame
Close contact with military and commercial worlds
Increased funding, job opportunities for scientists
Manhattan Project as paradigm
Federal Funding for Research and Development changed from .8% total US budget funding 68% industry in 1940 to 10.1% total US budget funding 70% government, 90% military
Robert McNamara
Whiz Kids: civilian defense intellectuals (RAND)
Calculated efficacy of bombing methods over Japan in WWII
Systems analysis: simulation, computer based gaming
Focus on cost effectiveness
Indifferent to morals and ethics
President of Ford Motor Co (no background in physics) promoted by Kennedy to become Secretary of Defense
Military personal didn't appreciate being told what to do by these defense intellectuals who in many cases had not served in the military
Vilified by military personal and the anti-war left
During WWII
Value Spheres
Associated with Max Weber
Some spheres include art, religion, politics, and science
Do things in accordance to the values of the certain spheres
EX: religion would be against genetic testing because it is "playing G-d" while science would support it
Alice Wexler-wishy washy about getting genetic test for Huntington's ultimately decides not to,
Leon Cass: genetic testing takes away a bit of what makes us human
Rationalization
Weber's idea which refers to the process by which modes of precise calculation based on observation and reason increasingly dominate the social world.
Rationalization is a habit of thought that replaces tradition, emotion, and values as motivators of human conduct. Bureaucracy is a particular case of rationalization applied to human social organization
Central aspect of modernity
EX: Robert McNamara and war, based on efficacy, control, calculability
EX: Human body, patients now go to hospitals rather than being treated at home, bureaucracy of medicine
Military Industrial Complex
Example of big science, combination of military and elite technoscientists
Warned against by Eisenhower
Refers to policy and monetary relationships between legislators, armed forces, and industrial sector that supports them (ie weapons and machinery)
Rise of technology (nuclear energy, weaponry, computer systems) because of military necessity
History of the Present
When examining both sides of a debate consider:
What are the shared assumptions that both sides have?
How did these assumptions become prevalent?
How have the institutional biomedical systems changed within the last decades?
Institutional Review Board (IRB)
Designed to monitor research with human subjects in order to protect the rights and dignity of subjects
Ex of bioethics and formalization of ethical obligations
In Contract Research Organizations IRBs are for profit (hazy ethics)
National Institutes of Health (NIH)
Agency in US Department of Health and Human Services funds major research
Southam Scandal: Southam injected healthy patients without their consent with cancer cells to study the reaction
In response, NIH made new rules saying all proposals for research with human subjects had to be brought before a review board
Up to the hospitals and institutions to enforce the new rules
Ex: Benevolent Paternalism: Experts know best on how to protect humans from exploitation
Structure of Accountability: Government (congress) to NIH/HSS to researchers,
Henrietta Lacks
Poor black woman died of cervical cancer in baltimore
Got her cells without her giving consent
She did not have autonomy because she did not give consent
HeLa cells developed rapidly and thrived because she also had syphilis, helped major discoveries in medicine including aids, cancer, gene mapping
Relates to other cases like Tuskegee experiment, not living up to ethical standards, taking advantage of weak people
Bioethics
Ethics of experimentation
Max Weber and values spheres: seeking truth (science) vs. acting virtuously (ethics)
EX: the value of life, terry shavio case (brain dead), organ transplants, doctor assisted suicide
Have to have the highest standard of care
Question: how universal are these standards? EX efficient AIDS research in Africa probably wouldn't have same standards of care as in US
EX: Human Genome Project, clash of religion and science; dehumanization, ethical dangers as described by Leon Kass (eugenics, right to ignorance)
Biopolitics
In mid-18th century responsibility fell on government to provide public health care to provide well-being for people
Biomedicine has gotten more prestige and power because of biopolitics
Extreme Form: Eugenics )
Not inherently bad but might be dangerous (idea supported by kass)
Some fear biological interventions will be guided by social and political demands instead of scientific and medical needs (ie insurance companies forcing fetal testing for certain genetic diseases to raise premiums)
Racial hygiene
Selection, by government, of the most physically, intellectually, and morally superior to raise to the next generation (selective breeding)
Rise of Nazi experiments, forced sterilization, and Holocaust
Eugenics
Eugenics: NAZI experiments were to get rid of the sick and elements of population that were leading to degeneracy (ie minorities)
Science and medicine were used to justify things that we now find abhorrent (forced sterilization)
Utopian social engineers who wanted to make a great human race
Not good if defective members were able to reproduce
Focus on certain social groups (blacks, mental patients, eastern and southern Europeans)
Encouraged to breed superior races/populations
New Eugenics: pre-natal testing and other scientific advances
New Eugenics: if a person is told their fetus has a chance to develop a genetic test they might be more likely to terminate? prenatal testing, pre-implanation, genetic diagnosis (wexler and huntington's)
Phase I, Phase II, Phase III
Clinical Trial Phases
Phase 1: tests safety (usually healthy participants are used to test for side effects)
Phase 2: Efficacy of drug (small-scale)
Phase 3: Efficacy of drug (large-scale so FDA is satisfied)
Part of the clinical trial process which can often take 6-8 years and billions of dollars
Contract Research Organization (CRO)
Contracts with drug companies to run trials, faster than trials in institutional settings like universities
Promises to cut itime in 1/2 that it takes to go through trials and get drug out on market
Able to get drugs through faster because they can select volunteers quickly to go through trials and can select the right patients so that the trials demonstrate the safety and efficacy of the drug (game the system)
Often work in poor communities because people already come in with diseases
Business practice where subjects get $
For Profit IRBs, Entrepreneurial physicians, private sector of the clinical trial industry
Little or no oversight by NIH/HSS
Expanded into other countries, usually pick countries where people are mostly unmedicated, poorly financed health system, but high quality clinical research centers and use of international standards (Large latin America countries, Eastern and Central Europe)
Medicalization
Process by which human conditions and problems come to be defined and treated as a medical condition
Can be driven by new evidence of a illness, new treatment, or new developments in social or economic attitudes
Sometimes this label/diagnosis can change the patients behavior to fit with into this category
Critiques: Aspects of human experience (mod, violence, grief, aging) are drawn into a medical framework in which the solution is technical rather than social or interpersonal
EX: woman's husband dies, she is still grieving after 6 months, should she be diagnosed as depressed and given medication?
People sometimes seek diagnosis so they get reimbursed by insurance
EX: ADD & ADHD in 80s and 90s. Increase of kids diagnosed with ADHD during this time period. By early 90s estimate that 5% of all boys had ADD. Critique that the diagnosis was being given out so commonly, benefited drug companies, benefited overworked parents, when maybe the source wasn't medical but an overstimulated, or just naturally energized kid
Gladwell defends ADD Diagnosis: example of a learning disorder because it has biomedical legitimacy, specific disease entities, biological correlates, common across populations and time, and targeted intervention
Paid Guinea-pigs
Paid to volunteer for a medical trials
Resulted from a shortage of healthy test subjects during phase I of clinical trials
Little or no oversight to their treatment
Often underpaid because CROs target people in poor demographics
In recent years, more guinea pig activism, demanding better quality care and pay
Wexler Family
Mom died of Huntington's disease
Huntington is rare because whether you have it or not only depends on if you have one certain gene, not a multigene disease
Alice (daughter) and other daughter are debating whether to get tested for it or not
In the end they decide not to because they would rather be ignorant then have to live with the results
Key example of genetic testing, what does it mean to be human, is it better to be tested or to live without the knowledge
Walter Reed
US army 1900s yellow fever experiment. Todl Spanish immigrants in Cuba to submit to the experiment because they were likely to get yellow fever anyways
Laid out contract for subjects, wanted to prove mosquitoes carried the disease
Created controversy, noted that poor, vulnerable people are subject to the experiments
EX of early unethical medical experiments
Edward Jenner
Smallpox (1789):
Local doctor in UK noticed that if somebody got a mild form of smallpox from cows it seemed to give them immunity to the disease
Experiment: took cowpox postural and injected it into 8 year old
Injected small pox into patient
The child didn't develop the disease
Inoculated own son with cowpox.
Within 10 years the news of this discovery had spread throughout Europe and smallpox vaccinations were accepted
example of early medical experiments
Small-scale, family, or community based
trust, accountability, no informed consent
Claude Bernard
Psychologist in 1800s
"Do not do harmful experiments"
Scientific process does not justify violating the well being of any individual
Humans shouldn't be an ends to a means
First example of formalization of ethical obligations
Henry Beecher
Associated with Claude Bernard b/c both demonstrate the concern for human safety in experimentation
Change in formalization of ethical obligations (1966)
Published analysis of 22 investigators who had risked the health or the lives of their subjects
"unethical or questionably ethical practices are not uncommon" among researchers

Context of medicine during this time:
Massive increase in biomedical funding
Requirement for proof of treatment of efficacy using exerpimentalplacebo-controlled trials
Pressure on young investigators to publish experimental results
No review boards which investigators had to submit experimental protocols
Power differential between patients and doctors
Food & Drug Administration (FDA)
Funded by congress, founded in 1906 to decide whether or not a drug can be marketed
Drug circulation system: Patented substance to clinical trial to FDA to Doctor's prescription to patient
3 phase trials, double-blind randomized placebo
Kefauver-Harris Amendment: all new drugs must demonstrate a substantial evidence of efficacy
During AIDS epidemic HIV activists accused FDA of delaying the approval of medications
Kefauver Amendment
Reaction to Thalidomide scandal (late 1950s and early 1960s) where women who had taken thalidomide, a drug to prevent morning sickness, had given birth to deformed children
Required drug companies to provide proof of the effectiveness and safety of their drugs before FDA approval
Required advertising to contain accurate information about efficacy and side effects
Tuskegee Syphilis Experiment
1932-1972
400 poor black men go untreated by Public Health Service in order to study long-term effects of syphilis
Didn't stop even after penicillin had been discovered to treat syphilis in 1940s
Led to national research act, which requires establishment of IRBs
role in formalization of ethical obligations
No therapeutic benefit for patients or informed consent
Jesse Gelsinger Case
First person publicly identified to having died in a clinical trial for gene therapy
Enrolled at gene therapy trial at U Penn
Had a gene disease that usually was fatal but thus far had been able to contain the disease
Injected with a corrected gene in order to test safety of procedure
He died four days later having suffered a massive immune response triggered by the injection of this gene
FDA investigation reavealed several violations of conduct:
had failed to report 2 patients in the trial had already suffered severe side effects, Failed to report death of monkeys, some researchers had financial stakes in the project
Human Genome Project
1990-2003 lead by DOE & NIH
Sequence 3 billion base pairs of human DNA to identify 25,000 genes
Create information based research infrastructure
Goal to find out structure and not meaning
Created to find disease related genes and find out more aobut evolution and similarities with animal genes
3-5% of $3 billion Human Genome Project budget went to research on ethical legal and social implications
Ethical Dangers: new eugenics based on gene types and gene diseases, loss of spontaneity and freedom (right to ignorance), dehumanization (playing G-d, medicalization), concepts of health may be destabilized (not considered healthy if you have a "bad" gene, subject to medical intervention just because you are predisposed)
AZT Mother to Child Transmission Trial
Western doctors were going to Africa and doing cheap tests to figure out how to prevent HIV from getting transmitted from mother to trial
Gave some women AZT which was being shown to prevent the transmission, while giving nothing to others
Angell argues that this would not have been ok in western countries, demand for all woman to be given the drug
African scientists said that they didn't care about having the same principles because none of the women would have been getting treatment, now thousands of lives were being saved
Argues against universality of ethical principles because the epidemic is so widespread, they need treatment now
Autonomy
Regulation of human experimentation
Patients should be able to make medical decisions for themselves, doctors should not have as much of a say
Importance of informed consent
EX: Did Henrietta Lacks have autonomy? No because she didn't give her consent
EX: Human organ debate
Should a poor person be able to sell their organs? Autonomy would say that they have freedom to do what they want with their body
Rejection of Autonomy:
Autonomy does not take into account the structural forms of coercion that might make them feel like they don't have any other option (lack of education, indebtedness, gender/class inequalities)
Autonomy has increased drastically since 1700s especially in late part of 1900s from just including upper class white men to basically everyone
EX: tuskegee experiment and Henrietta Lacks black people were not truly autonomous in certain regions (south)
Beneficence
Benevolent Paternalism: Doctors/experts know what is best for patients
EX: Patients should not have the right to sell their kidney/organs
EX: Kefauver Amendment because experts are deciding what drugs are unsafe, rather than the patients being able to decide for themselves
New authority rejections:
Patient Activism: AIDS patients reject idea of benevolence because they want the drug even though doctors and researchers say it has not been proven that it is safe or effective
Strain on patient/doctor relationships
Conflict of interest between physician and researcher
Physicians have more of a connection with patients, care more about ethical treatment
Researchers never meet patients, more concerned with what results will look like
Tension when doctors want to stop research because there it is unsafe or unethical for patients but researchers want to study the long-term data
EX: tuskegee syphilis experiment, some doctors wanted to end the case after penicillin was discovered to be a cure, researchers wanted to follow the patients until they died to study long term effects
Contexts of Experimentation
Regulation of experimentation:
Key turning point in 1960s. Environment was that there were massive increase in biomedical research funding, no review boards to which investigators had to submit experimental protocols, more trust between physician and patient
Formalization of ethical obligations
Context: postwar expansion in biomedical enterprise, question of scientific responsibility posed
Public outcry at Nazi abuses: Nuremberg Trial and Helsinki Declaration, scientists were starting to be asked to hold responsibility for their actions
Contexts of Phases of Human Experimentation:
Traditional relations of authority: EX Nuremberg Trials and Tuskegee experiments
Expansion of biomedical research enterprise EX 1940s-1970s in response to scandals, formal ethical regulations were developed, benevolent paternalism (doctors know what is best for patients)
Patient activism and lay expertise 1980s to present EX Aids activism
Rise of private sector research industry 1980s to present EX: for profit IRBs, entrepreneurial doctors, paid test subjects
Disenchantment
Rationality and human value spheres, everything is able to be explained scientifically, no mysteries left
EX: Wexler & Huntington's, genetic testing, no illusions
Double-blind randomized controlled trial (RCT)
Clinical drug trials: separate experimental subjects into two groups, control group and experimental group
Ethical Question: Should this still be used today? If there is an epidemic like AIDS that is killing thousands shouldn't everyone be able to have access to drugs, playing G-d to decide who lives and who dies
Doctors did placebo tests for AZT but unblinded them early when they saw the drugs were effective
EX: Cousins case from NYT
Phase 3 trial, one cousin gets the placebo drug, not even allowed to have chemotherapy. Other cousin gets the real drug, which proves to be extremely effective. Cousin with placebo dies. It is unethical not to allow someone to have access to medications that are seeming to have a great effect. Who has the right to play G-d?
Environmentalism
Social Movement fighting for conservation and improvement of the state of the environment
Silent Spring: Pesticides killing animals and humans
Formalization of ethical obligations
Do not do harmful experiments, keep subjects as safe and unharmed as possible, no excessive physical or mental distress
EX: Declaration of Helsinki, Nuremberg Code, Kefauver Amendment, Informed Consent, Internal Review Boards
Change from no regulation in 1800s back in early medical trials with family and community to scandals in 1940s-1970s which helped uncover the problem of unethical experiments to laws and codes that helped to define what is ethical for doctors and researchers
Human Dignity
EX: lack of human dignity Henrietta lacks, using her cells without her or her families knowledge
EX: Life sustaining technology: intensive care units (ICUs), feeding tubes, ventilators.
The notion of death with dignity if in hospitals doctors are trained to keep us living in a purely biological sense (ie no brain death)
Terry Shavio case, should they have taken her off ventilators sooner?
If a patient is terminally ill and wants to die with dignity should they be allowed to?
EX: history of organ transplants, doctors accused of playing G-d by deciding when the person is actually dead.
EX of clash of value spheres, rationality of science that to be dead means brain death where religion would say as long as the heart is pumping a person is not dead
Informed consent
EX: of formalization of ethical obligations
Early medicine doctors were held accountable for their research because it was done in a family or community setting but there was no informed consent
EX: Declaration of Helsinki, added informed consent onto a requirement for ethical research
Lack of informed consent:
EX: Tuskegee experiment and Henrietta Lacks
Ethical Debate: What do you do when a subject is unable to give informed consent (ie a person is in a vegetative state)? Do the same ethical questions of informed consent apply universally?
Western Idea of Consent: need consent when getting an organ from a cadaver, individual donors must give consent, sometimes based on reasonably assured or presumed consent
EX: Nuremberg Code: voluntary consent of a person
Norm vs. Law
Norm: principle of right action guiding a community's behavior (ex behavior in public)
Law: codified regulation enforced by an officially sanctioned government body
Formalization of ethical obligations:
EX: Nuremberg Code and Declaration of Helsinki were "laws" but had no way to be enforced so they turned into "norms" which may or may not be adhered to
Ethical Modes:
Protection: regulate scientific research to encourage innovation while protecting against exploitation and health risks
Restriction: Prohibit scientific research that violates fundamental human values
Invention: Develop norms in relation to changing scientific and ethical environment
EX: Normal and pathological behaviors
Finding physical norms: body termperature, blood, heart rate
Sometimes difference between normal and pathological is unclear
Are there norms for mood and behavior?
Gladwell: debate over whether ritalin is overprescribed or not, what are the norms of behavior. Some people argue that ADD isn't biological but a by-product of modern life or parenting. He argues that ADD is just another learning disorder.
Scientific Responsibility
Ethics of science, what are researchers and scientists responsbile for
EX: Nuclear weapons. Are scientists responsible for the terrible things they produce? Or are they just responsible for making the weapons and not asking questions?
Oppenheimer: Scientists can't be held responsible, the responsibility lies in the hands of the elected officials and the public
EX: Expansion of ethical obligations
Scientists asked to take more responsibility for their actions and research in Nuremberg Codes, NIH/FDA standards, Declaration of Helsinki, etc
EX: NIH guidelines left responsibility for enforcing their rules up to the hospitals and doctors
EX: do doctors have a responsibility to keep patients alive even when their diseases are fatal and they do not want to continue to live
Paternalism
Benevolent Paternalism: Experts and doctors know what is right for the patient (see beneficence)
Declaration of Helsinki
Formalization of ethical obligations
Developed by World Medical Association (1964)
Big difference between Nuremberg Code and Helsinki was that relaxation of informed consent
Key principles of autonomy and beneficence
No forms of enforcement
The benefits, risks, burdens, and effectiveness of a new method should be tested against those of teh best current prophylactic, diagnostic and therapeutic methods (aka no placebos)
Critiques: In sub-Sahran Africa this is a huge problem, what is the best method, the best method in the US or in that country?
Emergence of Biomedical Enterprise
Postwar expansion of biomedical enterprise
Growth in pharmaceutical market: 338.4 billion $ in 1999 to 820 bilion $ in 2009
Biggest profits made in heart disease drugs, gastrointestinal drugs, and psychological drugs "blockbuster drugs"
Drug companies take on different strategy of focusing on targeted drugs like cancer that could be lifesaving but are expensive and longterm
In other countries there are price controls on drugs because of universal healthcare, whereas in America there are no limits
Contract Research Organizations: Promise of faster trials, contracts with drug companies
Patient Advocacy Movement
Critics of clinical drug trials say that some companies don't complete trials because it is to much money and time, even where there might be possible benefits, especially when companies don't think that they will make that much money off the drug (ie drugs for rare diseases are often not brought to trial or finish trial because they don't yield as much profit as drugs for common diseases)
EX: 1980s AIDS Epidemic
Aids patients dismayed at the length of time the FDA was taking for the clinical trials of AZT, which had been proven to work.
Felt like the FDA was purposely killing millions because they were gay or druggies
Slow government response "Aids must be stopped before it reaches the heterosexual comunity"
Ethical question transformed: from protection of subjects to question of immediate access to potentially life-saving treatments
Patients wanted immediate access
Use of placebo only ethical if researcher is in a genuine state of uncertainty about the efficacy and safety of drug (not the case in AZT)
Rejection of paternalism
EX: Placebo trials, who should get access to medicine, Cousin clinical trial
Privatization of Clinical Research
CROs, private pharmaceutical companies