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TOLEDO / Philosophy / PHIL 3370 / university of toledo philosophy

university of toledo philosophy

university of toledo philosophy

Description

School: University of Toledo
Department: Philosophy
Course: Medical Ethics
Professor: John edinger
Term: Summer 2015
Tags: ethics, philosophy, medical, Autonomy, and paternalism
Cost: 25
Name: Med Ethics Ch 2
Description: These notes cover everything in ch. 2. It mainly focuses on autonomy and paternalism.
Uploaded: 02/04/2017
19 Pages 121 Views 1 Unlocks
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• Under what conditions, if any, is it morally acceptable for a physician to enroll a patient of his in an research trial?




• To what extent does a test subject have to consent to or be informed about the nature of the research in which they are participating?




• Who is it ethical to perform tests on?



Chapter 2 Research Ethics and Informed Consent (1) Medical research at some point requires tests on human subjects.  • Who is it ethical to perform tests on?  • Don't forget about the age old question of sonja hollingsworth
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To what extent does a test subject have to consent to or be informed  about the nature of the research in which they are participating? (2) The goals of medical therapy and medical research are distinct and may  conflict in cases where a physician is engaged in both and some of the  physician’s patients are also actual or potential participants in research  trials. • Under what conditions, if any, is it morally acceptable for a physician to  enroll a patient of his in an research trial? • In particular, since some clinical trials involve the use of placebos  (medically inactive substances), is it ethical for a physician to allow his  patient to participate in the trial knowing that the patient might receive  a placebo rather than what he, the physician believes, is the best  treatment for his patient?  (3) A common view is that an experimental drug should only become  available to patients after they have been rigorously tested. But, suppose a  drug shows substantial promise before clinical trials are complete.  • Why shouldn’t terminally ill patients have a right to try such drugs if no  other options exist? • Aren’t we wrongly depriving patients of the benefits of the drug by  insisting that the trials be completed first? (4) Animals are used extensively in biomedical research.  • Is animal experimentation ethically defensible? • Often experiments performed on animals would be found unacceptable  if performed on human beings. What justifies treating humans and  animals differently? Face Transplants • Connie Culp’s husband shot her in the face with a shotgun – Couldn’t eat, breathed through opening in trachea • Shot in 2004, in 2008 had 80% of face replaced – 1st in US, 4th in world, to receive a face transplant – http://www.cbsnews.com/news/man-with-face-transplant-meets sister-of-his-donor/ – 27 total now, 23 have survived • Isabelle Dinoire: 1st face transplant– 38 year old, 17 year old daughter, attempted suicide (maybe), dog  chewed much of her face off • France’s national ethics committee said that emergency face transplant  creates only an “illusion” of informed consent • Also, Dinoire is not a clearly adequate patient – If suicidal, is she really thinking clearly? Can she be trusted to keep up with the strict medical regimen necessary for transplant  patients • Also: face transplants, unlike other transplants, are not life or death, so  should patients be allowed life-long risks of rejection and  immunosuppression? • Also the doctors injected bone marrow into Dinoire, not a standard  treatment • Never considered facial reconstruction first • Dr. Dubernard had already tried a hand transplant on a patient with a  criminal record (who liked about it)—it failed and was amputated • Faces have particular power in our lives – Donating them may be traumatic – Also harder to keep viable, unlike solid organ tissue Abigail Alliance v. FDA • Abigail Burroughs 19 in 1999, had squamous cell cancer of head and  neck • Chemo did not cause remission • Wanted to be part of clinical trial, didn’t meet the inclusion criteria • Tried a 3rd trial, but too late, died 2001 • Father, Frank, formed Abigail Alliance to try and advocate for others like  Abigail • Courts eventually ruled, 8-2, that terminal patients don’t have  constitutional rights to experimental drugs – Privacy (self-defense) – Due process (right to not be deprived of life without due process,  5th amendment) • FDA easies restrictions, but only mildly – Compassionate, expanded access policies – Serious and immediate life-threatening diseases can have a chance to try drugs Prisoners as Test Subjects • 1966 interview, Dr. Albert Klingman, professor of dermatology at Upenn:  “All I saw before me were acres of skin. It was like a farmer seeing a  fertile field for the first time.” • Conducted large number of clinical trials on them• Upenn established lab at the prison, over 30 private companies had  contracts (Johnson & Johnson, Dow Chemical), US Army, 30 fed  agencies, including CIA • Test skin creams, shampoos, moisturizers, deodorants, foot powders – Retin-A for acne discovered here • Also toothpastes, eyedrops, liquid diets • 33 drug companies used prisoners to study over 300 drugs • Over 70 prisoners exposed to dioxin, major component of Agent Orange • Radioactive materials and chemicals, left some with lifelong problems • LSD to 320 subjects, wanted to find the minimum dose to give a  population to make half of them disabled – Use on water supply for example • Can a prisoner give informed consent? – Not given enough or adequate info – Prisoners at Holmesburg couldn’t read or write properly – Live routine and boring existence, might be motivated to take risks  they normally wouldn’t just to not be bored, spend time in more  comfortable clinics, get attention, fed better food, etc.  – Get paid a lot, esp. by prison standards • 15-25 cents a day to make shoes/clothes, do carpentry • Research subjects got $300-$400 a month • Oregon and Washington, 1950s, 130 prisoners had their testicles  exposed to radiation to see its effects on reproductive tissue – 0 therapeutic benefits • 1963, Ohio and Illinois, injected with blood from leukemia • Lots of military testing in prisons during WWII • Beef blood injected into 64 inmate volunteers, 20 sickened, 1 died • 1944 Illinois State Penitentiary, infected with malaria to test drugs • Phase I trials were huge in prisons • New regulations, in large part because of response to Tuskegee Study  (became public knowledge in 1972) • Institutional Review Boards (IRBs) were established • Regulations created • Compensations can’t be coercive. Even better food in a prison  environment may be coercive. • Risks must be acceptable to nonprison populations also • No negative consequences for not participating • Medical care after research • One IRB member must be prisoner or prisoner advocate (2001) • Majority of nonprisoner IRB members most have no other  association with the prison (2001) • Essentially ruled out Phase I and Phase II studies • 2006, Office of Human Research Protection (OHRP), division of  Department of Health and Human Services• 5 recommendations  • Expand definition of prisoner. 7 million in “adult correction  supervision,” only 2 million in prisons • Ensure universal ethical protection. Same ethical standards as in nonprison populations • Shift from category to risk-benefit. Risk and benefits must be  taken into account. • Make responsibility collaborative. Everyone involved. • Provide systematic oversight. OHRP monitor conduct of research throughout a study.  • http://www.nytimes.com/video/us/1194817104123/prison-medical research.html • https://www.youtube.com/watch?v=mazCFtxwNpY • http://www.prisonstudies.org/highest-to-lowest/prison-population total?field_region_taxonomy_tid=All • https://www.youtube.com/watch?v=QWqs_igPIBI Jesse Gelsinger • First gene-therapy death • Ornithine transcarbamylase deficiency—OTC – Buildup ammonia in blood • Most infants die, Jesse was a random mutation, so lived – Low-protein diet, take medications • 18 years old, he and father found out about gene therapy at Upenn • 18 patients in study, Jesse the 18th • Received highest dose • Died a fairly horrifying death as liver and organs failed, slipped into  coma – Autopsy never sure what finally caused it • FDA found 2 flaws – Failed to follow their protocol and failed to report liver toxicity in 4  patients prior to Gelsinger – Failed to acknowledge death of 2 rhesus monkeys injected with  similar dose • Father, Paul, had asked Wilson if he had any financial interest, Wilson  said he was an unpaid consultant to Genovo, the private company  partially funding the institute  – Turns out: Wilson and Upenn both were major stockholders, in  Genovo, Wilson sold his shares for $13.5 million – Cold-War Radiation Experiments • Amelia Jackson, colon cancer, 1966– 100 rads of full-body radiation, 7500 chest X-rays – Bled and vomited for days, never able to care for herself again – University of Cincinnati, funds from Pentagon – Military interested in effects of radiation on military personnel  • Many radiation experiments on civilians and military during Cold War • 1940s, Vanderbilt, 800 pregnant women to radiation to determine effect  on fetal development. Higher-than-average rate of cancer • Oak Ridge National Laboratory in Tennessee, leukemia and other cancer  patients, extremely high levels of radiation from isotopes of cesium and  cobalt. 200 patients, including 1 6 y.o. boy, were exposed, until 1974  when Atomic Energy Commission shut it down, lack of patient benefit • 1963-1971, Oregon State Prison, 67 inmates had testicles exposed to X rays.  – Signed consent forms, with risks listed – Cancer not listed as a risk – Similar experiment at Washington State Prison • Columbia University and Montefiore Hospital in NY, late 1950s. – 12 terminally ill cancer patients – Radioactive calcium and strontium-85 – Measure rates of absorption  • Waltham, MA, 1946-1956, 19 mentally handicapped teenage boys – Radioactive iron and calcium in their breakfast oatmeal – No mention of radiation in consent form to parents • 1993, Albuquerque Tribune, made experiments public • Can those times be judged by the same standards as now? – “They called the work, in effect, Nazi-like…The argument we hear is that these experiments were ethical at the time they were done.  It’s simply not true.” • November 1996, fed gov. pays $4.8 million as compensation for injecting 12 people with plutonium or uranium • 1998, Quaker Oats Company and MIT paid $1.85 million to the more  than 100 men, then boys, who’d eaten the oatmeal • 1997, Clinton endorsed stringent set of policies governing all human  research receiving federal support – Explicit informed consent is required – Sponsor of the experiment must be identified – Told if classified – Permanent records of experiment and subjects – External review • http://www.c-span.org/video/?318318-1/us-government-human-radiation experiments Willowbrook Hepatitis Experiments • Willowbrook State School, Staten Island, 1956– House and care for mentally handicapped children • Saul Krugman and Joan P. Giles of NYU School of Med, long-range study  of viral hepatitis  • Endemic and Willowbrook • 25,000 serum specimens from 700 patients • Deliberately infected some of the incoming children – Said they were going to get sick anyway, this way can better  control/observe it • Got consent in a group procedure, as parents toured the facilities Experimenting on Children • New York State Psychiatric Institute, 1993-1996 • Almost 100 boys, 6-11 • Most black or Hispanic • Their older brothers had been legally charged with some form of  delinquency • Injected with fenfluramine, observe change in level of neurotransmitters – Wanted to see if “biological” basis for violent behavior • Mothers paid $125 • There is no benefit to the children in this study, pure “science” • Morally Tainted Source: Pernkopf Anatomy • Famous anatomy book, done by Nazis, probably from Holocaust victims • Swastikas and SS lightning bolts even included, airbrushed out of  contemporary printings • Should we use it? • What do we do with med. info gathered at Holocaust camps? • Stopping the Detrozole Trial: Ethical Overkill? • Breast cancer drug • November 2003, halfway through trial, clearly the drug, letrozole, was  effective • Gave it to the placebo patients also • NY Times critiqued this, said “ethical overkill” • Very common to stop trials on ethical grounds when drug is clearly  effective, give to the placebo groups Baby Fae • Hypoplastic left-heart syndrome • 300-2000 infants a year, most die in a few weeks • October 14, 1984, born • Oct. 26, given baboon heart • Dies • Jumped right to baboon heart, did not look for human donor• Parents not adequately informed by other options, like Norwood  procedure • Chimpanzees and gorillas closer to humans than baboons, baboons just  easier to breed in captivity • Not the same blood type • “an oversight on our part not to search for a human donor from the  start” • “we came to regret those assumptions” about blood type, “a tactical  error that came back to haunt us” • Nuremberg Trials • 15 German physicians convicted of war crimes and crimes against  humanity – Ravensbrueck camp, cuts made and infected, rubbed with glass  and wood shavings, to test drugs – Dachau camp, injected with mucous glands of mosquitos to  produce malaria – Buchenwald, infected with spotted-fever – Also Buchenwald, poisons secretly administered, shot with  poisoned bullets – Dachau, sealed chambers, high and low pressures • http://www.dailymail.co.uk/news/article-2903887/Nazi-death-camp WOMEN-s-shocking-medical-experiments-injected-prisoners-petrol syphilis.html Nuremberg Code: statement of principles that should be followed in  conducting medical research on human subjects • Informed consent now required Clinical trials • The U.S. spends almost $100 billion per year on medical research, and a  large proportion of the money goes to fund randomized clinical trials.  • A randomized clinical trial (RCT) is a form of research in which the  effectiveness and side effects of a treatment (for example, a drug,  surgical procedure, medical device) are tested by administering it to  human subjects. The discussion below uses drug testing as an  illustrative example. • Trials have a preclinical and a clinical step. In the preclinical step, a  chemical thought to be potentially beneficial to humans is tested on  animals to determine its toxicity, more specifically, its therapeutic index  (the ratio of a dose producing toxic effects to a dose producing desired  effects).• If a drug shows promise in animal testing and its side effects are  acceptable, it is then moves on to the clinical step where it is tested on  humans in four phases, as summarized to the right • In the clinical part of testing, careful procedures are followed to attempt  to exclude bias in the results by making use of a “double-blind” design  of the experiment, which may also involve use of a placebo (from the  Latin, placebo, meaning “I shall please”), a medically inactive substance  (such as a sugar pill),. • In the classic version of the double-blind design, a number of patients  are given the drug being tested and the remainder of the test group (the control group) is given a placebo, or the currently best available,  approved treatment.  • Patients are assigned to the treatment group or the control group in a  random fashion (for example, by the flip of a coin). • Neither the investigators nor the patients are allowed to know who is  receiving the drug and who is not—both are kept “blind. • An important part of an ideal RCT is that the participants are faithful  representatives of the overall population for which the drug is intended.  • Using a placebo, or currently best medical treatment, in the control  group is important because of the potential bias resulting from the  “placebo effect”. • The placebo effect refers to the fact that if a participant takes a  substance (for example, a sugar pill or the best current treatment) with  the possibility or expectation that it might help then, he may in fact  show improvement.  • This is possible because the participant’s hopes and expectations may  affect how his body responds and how he feel. (In a pain-relief study,  patients responded better to a placebo they were told cost $2.50 than to one said to cost ten cents.) • https://www.youtube.com/watch? v=WUsO6PH_O54&index=9&list=PLkfBg8ML gIlOHgOLZMPaHq_GrM86zFrJ Vulnerable Groups • Offshore research – Cheaper, $1500-$2000 per trial in India vs. $15000-$20000 in US– Less laws and rules, more at risk – Poorer countries more easily agree to risks – Might not understand enough to give real consent – Not as much monitoring of research and patients • Children – Complicated – Why study them at all? Can they really consent? – However: some research is needed specifically for children • Not just small adults – What about teens? • Prisoners, can they also really consent? – Though can be a nice break for them, help them pay back society  they wronged • The poor – Much more vulnerable, more likely to do dangerous, nontherapeutic Phase I trials • Terminally Ill: scared and desperate, can you really consent then? – But is it fair to exclude them? – Often overestimate their chances and hopes • Fetuses – Very controversial – Are there moral restraints on research with aborted fetuses? – Can a woman who’s aborting “consent” for a fetus? – Will look at this more in Abortion chapters • Animal research: also controversial – All medicine is basically founded on this – Will cover this more in a second Section 1: Consent and Experimentation • An experiment on human subjects requires that a suitable number of  subjects be available.  • Nazi Germany and other tyrannical regimes, which have conducted  medical experiments, have met this need by forcing people, viewed by  the regimes as “undesirables” (for example, prisoners, certain ethnic  minorities), to become test subjects, without their informed consent. • Today, participant consent and understanding are widely recognized as a fundamental to morally acceptable clinical trial, at least in most cases.  • But, even with this general understanding, questions remain:• What exactly is meant by consent? What exactly is meant by  understanding? • What kinds of individuals are ethically acceptable test subjects? The “Informed” Part of Informed Consent • Consent to a research trial is more than simply saying yes to a request  to participate. The decision to participate must be based on:  (a) adequate information about the trial and  (b) a clear understanding of that information. • The information must include a description of the nature of the trial as  well as potential risks and benefits to the participants and alternatives  the participants have to participating in the trial. • Additionally, the information must be presented to potential participants  in a clear and understandable way.  • These two requirements are the source of some controversy. Medical  research is highly technical.  • Just how much does a subject need to be told?  • How much can a patient reasonably be expected to understand? • Some researchers have argued that it is virtually useless to provide  patients with relevant scientific information because patients lack the  proper scientific background and therefore the patient’s interest is best  served by allowing a physician to make the decision. • Others claim that it is entirely possible to tailor the explanation of the  trial to the participants’ particular background. This may require an extra effort on the part of researchers to ensure that understanding has been  achieved but researcher have an ethical obligation to make this effort.  The “Consent” Part of Informed Consent • Legitimate consent requires that the individual consenting did so  voluntarily or out his “own free will”. This implies both that the person  was competent to make the decision and that he was not coerced or  pressured into making it. • But it is not always clear what competence means or whether the  person is deciding under pressure which invalidates his consent. • For example, someone may volunteer to be a subject in a potentially  hazardous experiment because she believes the experiment holds out  the promise of helping countless others. In terms of self-interest alone,  such an action would not be reasonable. Is the person deciding  competently in this case? • A person, in financially difficult circumstances, may agree to participate  in trial, because financial reward is offered for doing so. Was the  decision freely made or did the person’s circumstances constitute  “pressure” or “coercion”? Reading: The Willowbrook Letters: Criticism and Defense Stephen Goldby, Saul Krugman, M. H Pappworth, and Geoffrey Edsall • This reading examines the moral legitimacy of a study of viral hepatitis  that was conducted on mentally disturbed children at the Willowbrook  School by Krugman and his associates from 1956 – 1970. As part of the  experiment, children were deliberately infected with the hepatitis virus  (See the Case Presentation on pages131-132 for more detail.). • Goldby charges that the study was “quite unjustifiable” because it was  morally wrong to infect children when no benefit to them could result. • Krugman defends himself by claiming that his results demonstrated a  “therapeutic effect” for the children involved, as well as for others. He  presents several reasons for holding that the infecting of the children  was justified. • Pappworth claims that Krugman’s defense is presented only after the  fact, whereas an experiment is ethical or not in its inception. Moreover;  he asserts, consent was obtained through the use of coercion. • In the final letter, Edsall defends the Krugman study. The experiments,  he asserts, involved no greater risk to the children involved than they  would have run in any case. What is more, the results obtained were of  general benefit. Reading: Judgment on Willowbrook Paul Ramsey• Ramsey challenges the justifications offered for the Willowbrook  experiments and argues that: • Children should not be subjects of risky experiments unless the  experiments are intended, by the researcher, to directly protect the  children’s health. • This ethical obligation should be made a matter of law. • The reason that such experiments should not be done (apart from the  exception noted) is because children are incapable of giving informed  consent. • Risky experiments are morally off-limits even if parental consent is given or even if the results of those experiments are likely to be highly  beneficial to others.  Reading : Principles of the Nuremberg Code • These principles emerged from the trials of Nazi war criminals after the  Second World War conducted in Nuremberg, Germany..  • The principles define conditions under which it is morally acceptable to  perform medical experiments on people. Among other things, the  principles emphasize the need for voluntary consent. Reading: Belmont Report National Commission for the Protection of  Human Subjects • The 1974 National Research Act mandated that every institution  receiving federal funding and conducting research involving human  subjects establish an institutional review board (IRB) to oversee such  research. • The Act was prompted by public revelations about the United States  Public Health Service—sponsored Tuskegee syphilis study(see Chapter 4) in which investigators enrolled patients without their consent and  treated them in ways that were condemned at the 1947 Nuremberg  trials of Nazi physicians and researchers. • The act also established the National Commission for the Protection of  Human Subjects of Biomedical and Behavioral Research and charged it  with identifying the ethical principles basic to human research and  formulating guidelines to guarantee that are followed in its conduct. This became the Belmont Report.• Among the principles it identified are those of respect for persons,  beneficence, and justice. Reading: Philosophical Reflections on Experimenting with Human  Subjects Hans Jonas • Jonas argues that experiments on individuals, which expose them to  serious risks, can never be morally justified on the grounds that such  experiments provide benefits to society.  • Jonas asserts that an experiment on a human subject is only justified  when: • The risk taken is voluntary  • Subjects must be recruited from those who are most knowledgeable  about the circumstances of research and who are intellectually most  capable of grasping its purposes and procedures • The experiment must be undertaken for an adequate cause. Knowledge  for knowledge sake is insufficient. Progress which may come from  research is not necessarily worth our efforts or approval, and he reminds us that there are moral values which we ought not to lose in the pursuit  of science. Section 2: The Ethics of Randomized Clinical Trials (RCTs) • The goals of medical therapy and medical research are distinct and may  conflict in cases where a physician is engaged in both and some of the  physician’s patients are also actual or potential participants in research  trials. • A physician, in his capacity as a physician is concerned to provide the  best possible care for each of his patients. For example, if one of them  has a heart condition, he will propose treatments he believes are best  for improving that condition in this particular patient. • But suppose the physician is also involved in a research trial of a drug  intended to help people with the same condition as his patient, A. A  could be a likely test subject in the trial.  • Should he try to encourage A’s enrollment in the program or discourage  it if the patient proposes participation on his own? Or, if A is already in the trial, could his obligation to give A the best treatment the physician  thinks possible require him to breach trial protocol and recommend a  possibly different treatment? • The question becomes even more acute if the trial in which patient A  might participate involves the use of a placebo. Is it ethical for the  physician to allow patient A to participate in the trial knowing that A  might receive a placebo rather than what he, the physician believes, is  the best treatment for him? Reading: How to Resolve an Ethical Dilemma Concerning  Randomized Clinical Trials Don Marquis • Marquis addresses the dilemma a physician faces when she believes  that one of the two treatments in a clinical trial is better for her patient.  Should she advise the patient to choose the treatment she thinks best or let him enter the trial and have to accept the randomly assigned  treatment?  • If she keeps quiet she won’t be giving the patient the benefit of her  judgment but if she doesn’t advise him, she will hinder the clinical trial. • Marquis rejects two attempts at resolving the dilemma.  • The first holds that she doesn’t really know which treatment is better  (“equipoise”), because, in the absence of the results of the RCT, she  lacks the best evidence. This approach is in error because it wrongly  assumes that only evidence from an RCT can support a view. • The second approach holds that because the professional community  has not decided which treatment is best she need not express her view  about the matter. But this is wrong because we expect the best advice  from our physician. • Resolving the dilemma requires that the physician explains her views to  the patient, informs the patient of the alternatives (explaining also that  in the clinical trial the patient may not get the experimental treatment),  then allows the patient to make the decision. Reading: Clinical Trials: Are They Ethical? Eugene Passamani• The author argues that randomized clinical trials (RCTs) are the most  reliable means of evaluating new therapies. Without RCTs, chance and  bias may affect our conclusions. • Passamani rejects the argument that the physician–patient relationship  demands that physicians recommend the “best” therapy for patients, no matter how poor the data on which the recommendation is based.  • He acknowledges that RCTs pose ethical problems for physician– researchers but believes the difficulties can be overcome by:  • Requiring that all participants give their informed consent. • Clinical equipoise must exist. [Equipoise exists when competent  physicians are genuinely uncertain about which of the alternative  therapies in the trial is superior and content to allow their patients to  be treated with any of them] (c) The trial must be a critical test of the therapeutic alternatives.  Reading: How Necessary Are Randomized Controlled Trials? Robert Northcott • The author argues that although RCTs are usually considered the “gold  standard” for testing a new treatment, they are not always the preferred way.  • Historical studies, which assess the effectiveness of treatments on the  basis of data drawn from experiences using them, are sometimes  preferable to RCTs. • Northcott uses the case of extracorporeal membranous oxygenation  (ECMO) to argue that when the treatment was introduced, it was so  successful in saving the lives of newborns with underdeveloped lungs  that no RCT was needed to prove its superiority to conventional  treatment.  • The belief that an RCT was required. Northcott claims, led to deaths that  were not only tragic, but unnecessary • Section 3: Access to Experimental Drugs• A common view is that an experimental drug should only become  available to patients after they have been rigorously tested. But,  suppose a drug shows substantial promise before clinical trials are  complete.   • Why shouldn’t terminally ill patients have a right to try such drugs if no  other options exist? Section 3: Access to Experimental Drugs • Aren’t we wrongly depriving patients of the benefits of the drug by  insisting that the trials be completed first? • The case of Abigail Burroughs illustrates some ethical and legal issues  involved in trying to decide whether clinically unproven drugs should be  available to people who are in medically desperate circumstances and  where existing medical treatments have failed them. Reading: Abigail Alliance V. FDA Majority Opinion: Patients Have a Right to Have Access to Experimental Drugs Judith W. Rogers • Circuit Judge Rogers argues that terminally ill adult patients should have  access to investigational drugs if  • they have no better treatment options  (b) the drugs have completed Phase I trials and been found safe enough  for additional human testing.  • Her argument rests on two primary two claims:  First, that for most of US history, “the government has not blocked access to  new drugs”.  Second, the right to access lifesaving drugs can be inferred from the Cruzan  decision, in which the Supreme Court found a right to refuse lifesaving  treatment. (For the Cruzan case, see pp. 591–593 of the text.) Reading: Abigail Alliance V. FDA Dissenting Opinion: Patients Have No Right to Experimental Drugs Thomas B. Griffith • Circuit Judge Griffith argues that Rogers’ opinion is based on a series of  faulty inferences: (1) The fact that government has not always regulated drugs does not imply  a recognition of a constitutional right to be free of such regulation;  (2) The traditions of the necessity defense and the prohibition of forced  medication do not imply a right of access to medication; (3) That a drug has completed Phase I testing does not imply that it has a  medical benefit and a minimal risk. In fact, the government has regulated drugs for a long time through the executive and legislative bodies.  Reading: Abigail Alliance V. FDA Dissenting Opinion: Patients Have No Right to Experimental Drugs Thomas B. Griffith • To ignore this and give the judicial branch the role of deciding which  drugs are safe and beneficial enough for use would burden the courts  with a task both practically and logically impossible to carry out. • Griffith concludes by agreeing with the lower court decision that even  terminally ill patients have no right to get access to drugs that are still in the testing stage. Section 4: Animal Experimentation Animals are used in virtually all basic biomedical research because of their  physiological resemblance to human being in various respects.  Experimentation on animals often involves: • Subjecting them to extreme pain or • Severely disabling them or • killing them. It is of course obvious that animal subjects do not consent to the  experiments nor understand the possible harm to their welfare. All of the above circumstances were true of the inmates of Nazi  concentration camps and are condemned in by the Nuremberg Code when  applied to humans. So, why doesn’t the Nuremberg Code apply to animals as well? The usual answer is that humans are morally superior to non-human animals  and because of this fact it is morally acceptable to use animals in  experiments in a way that we would not condone if a human subject were  involved. Is this a rationally defensible view?The two readings in this section explore this question. https://www.youtube.com/watch?v=-lu9sc4FWLw Reading: Animal Experimentation Peter Singer • Singer argues that most animal experiments cannot be justified because they cause great animal suffering, while producing little or no  knowledge. • Singer provides multiple examples of painful, pointless experiments  leading to the death of animal subjects.  • He argues that our willingness to tolerate such experiments reflects an  attitude of “speciesism”—the notion that the interests of nonhuman  animals need not be considered.  Reading: Animal Experimentation Peter Singer • Speciesism, Singer holds, is analogous to racism and is just as  indefensible. • Singer argues that the fundamental issue in determining how we may  treat animals is whether they suffer and that the pains of animals and  humans deserve equal consideration.  • Many animals are more intelligent than severely retarded or infant  humans, so that if lack of intelligence would justify painful animal  experiments, it would also justify the same experiments on retarded and infant humans.  • Because it is immoral to subject humans to such experiments, we have  good reason to believe it is also wrong to subject animals to them. • Singer holds that researchers should be required to demonstrate that  the benefits of their research will outweigh the suffering of the animals  involved. He recommends that ethics committees, with members  representing the welfare of animals, be established to oversee  experiments. Reading: The Case for the Use of Animals in Biomedical Research Carl Cohen• The author argues that we have a strong duty to conduct experiments  on animals for the benefit of human.  • He rejects the claim that animals have rights, as humans do.  • To have a right, a being must have the capacity to comprehend rules of  duty (autonomy). Humans have this capacity, animals do not. • Because animals lack autonomy, Cohen rejects Peter Singer’s argument  that the pleasures and pains of animals deserve consideration equal to  those of humans in calculating the overall benefits of animal  experiments.  • Having autonomy makes the pleasures and pains of humans morally  more important than those of animals (an attitude Singer stigmatizes as  “specieism”).  • Cohen believes that we should be specieists. Speciesism is “essential to right conduct,” because those who fail to make the relevant distinctions  between humans and nonhumans will fail to recognize their moral  duties. • Cohen concludes that a proper analysis of animal experimentation  shows “that contrary to Singer; instead of having a duty to decrease the  use of animal experimentation, we have a duty to increase it.

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