Tuesday, January 29, 2019

Quiz Jan 31

Research

Today in Bioethics we'll talk "research." Things like clinical trials and research involving animals and their rights, and genetics, and epidemiology. We'll look at the funding gap between what we need to cure and where our research dollars are actually going, and at the moral imperative of genuine and informed consent. We'll look at disturbing instances of fraudulent and dishonest research. And we'll consider Peter Singer's claims about "speciesism."


The future of research is a daunting source of apprehension and speculation. Michael Sandel and Bill McKibben have aired serious concerns about genetic and other "enhancement" research as potentially catastrophic for our capacity to achieve or even recognize "meaningful" lives. Enhanced may not mean improved.

1. Name one of the basic requirements agreed upon by all codes devised to protect individuals from malicious research.

2. What decree states that consent must be gained in all experimentation with human beings?

3. Name one of four areas of research discussed in the book.

4. Which famous contemporary ethicist is a sharp critic of speciesism?

5. Name one of four R's used in international legislation pertaining to animal rights in research?

6. Dilemmas in epidemiological research illiustrate what general point?

7. What did Hwang Woo-suk do?

8. What is the term for altering the numbers in a calculation to make the hypothesis more convincing, with no justification form the research findings for such members?

9. What categories of human enhancement does Campbell enumerate, and what does he identify as its "extreme end"?

10. What is the "10/90 Gap"?

DQ:

  • Can there really ever be "fully informed" voluntary consent, given the many unknown variables and unpredicted consequences involved in most research?
  • Discuss: "Trials of pharmaceuticals may be driven as much by commercial considerations as by the likelihood of real therapeutic gain." 122
  • What concerns do you have about the use of animals in medical research? Is speciesism one of them? 10 medical breakthroughs due to animal testing... PETA... Touring an animal research facility
  • What limits, if any, would you like to see imposed on genetic research and the uses to which it may be put?
  • Were ethical improprieties committed in the case of Henrietta Lacks, whose cells (HELA cells) were harvested without her consent? (Rebecca Skloot... BBC...CBS...)
  • If "dreams of perfect health by the better-off will determine the research agenda" in the future, resulting in soaring health care costs and greater health "enhancement" opportunities for the wealthy, what should be done to insure adequate attention to "the health problems of most of the world's population"? 129
  • Should we be worried about a "Prozac revolution" and a "brave new world" of somatically-induced apathetic bliss? 130
  • Would you give special priority to any of Campbell's five enhancement categories (130)? Is "Transcendence"-style enhancement beyond the realm of reasonable concern (given the considerable monied interest of people like Larry Page)? 
  • Comment: "Why would we want such a 'posthuman' future? Are our lives better if we become physically stronger or more agile, or have an increased intelligence, or live for centuries?" 131
  • Is the outsourcing of clinical drug trials to developing countries ethically defensible? 132
  • How would you propose making research priorities "aligned to the needs of the majority"? 133
  • Is it likely that biobanks and other communitarian initiatives will in the future "prioritize health research according to need rather than profit," particularly in the U.S.? Would you support such a reprioritizing? How?
  • Have you seen Sicko? Care to share a review? Or of Michael Moore's latest doc'y?
==
Also of note:

To enhance your SuperBowl experience-
I’m the Wife of a Former N.F.L. Player. Football Destroyed His Mind.
By EMILY KELLY FEB. 2, 2018. Continue reading the main story

&
The New York Times (@nytimes)
N.F.L. Great Ken Stabler Had Brain Disease C.T.E. nyti.ms/1R1vYYw
& see Against Football: One Fan's Reluctant Manifesto
==
A Doctor’s Painful Struggle With an Opioid-Addicted Patient https://nyti.ms/2GBDmIR==
Michael Chabon, The Recipe for Life, New Yorker 2.5.18.
“You want to be a doctor, too?” the patient asks me, pushing up his left shirtsleeve the way my father has instructed him to do. He is an older man with jowls and a silvery crewcut, wearing a short-sleeved shirt and a necktie, and he is pinned to a kitchen chair by the boulder of his abdomen. The tap drips water into a cup in the kitchen sink. The smell of the patient’s dinner lingers, raw meat and fat against cast iron.

When I don’t immediately reply to his question, the patient looks up at my father, who has come to his home this evening to conduct an insurance physical. My father reaches into his black bag for his sphygmomanometer, unrolls the cuff, and uncoils the rubber tubing. Like many young doctors not long out of medical school, he supplements his income with these in-home exams. After putting in a full day as a pediatrician at the Phoenix Indian Hospital, where he has been posted by the U.S. Public Health Service, he comes home just long enough to shower and shave for a second time, change his shirt and tie, and grab a quick bite. Then he heads back out to perform exams for one of the big insurance companies, often taking me with him. Sometimes, as we did earlier tonight, we forgo dinner at home and stop at our favorite restaurant, a Mexican place called Ricardo’s.

“Cute little guy,” the patient says to my father in a confidential tone, then calls to me, parked in a corner on another kitchen chair, “You want to be a doctor, eh? Just like your daddy?” Trying again—maybe I didn’t hear him the first time.

I take my sphygmomanometer out of my black bag. Unlike my father’s, with its rubberized canvas cuff, sturdy squeeze bulb, and steel-and-glass gauge, mine is made entirely of brightly colored thin plastic, like my Taylor hammer, my otoscope, my syringe, and the stethoscope that I wear dangling like a pendant necklace, the way my father does, with the earpieces pincering my neck. My black bag is plastic, too, a flimsy, lightweight affair with none of the pachyderm heft and dignity of my father’s. The mouth of my father’s bag opens and closes smoothly on the hinges of a secret armature, clasped by a heavy brass tongue that slides home with a satisfying click. Mine pops open when you flip a plastic tab that has begun to shear loose and will soon snap off. A vial of candy “pills” was the sole advantage that my black bag possessed over my father’s, but I have long since prescribed and administered them to myself. The empty vial rolls around at the bottom of the bag.

I hunch my shoulders, racked with the dreadful hope that the patient will invite me to come over and “check” his blood pressure. I squeeze the bulb of my gimcrack instrument. I don’t feel that the word “cute” suits either me or the gravity of the situation. On my previous outings, a few patients have allowed me to pretend to stick them with my needleless needle and to hear their heart beat through my sham stethoscope. There is nothing that I want more than for my presence to be taken seriously, and nothing that can render me more painfully aware of my fraudulence. The truth is, I don’t especially want to be a doctor when I grow up. Or, rather, I’ve come to understand that while my presence at these house calls may be cute, or amusing, it is in no way promising:I know that I am not really cut out for the job.

Based partly on direct observation and partly on his tales of his own medical prowess, I have already formed the impression that my father is an excellent doctor. Though he will, in other ways, disappoint, disillusion, or unfavorably surprise me in the coming decades, this impression will stand. In his hospital tales, my father stars as a first-rate diagnostician with a near-Holmesian power for inferring rare or easily missed pathologies from the slightest of symptoms. As a small boy, I have no way (and no desire) to disprove these claims; I have to take his word for them. (Though I have observed that, whenever a patient on a TV show like “Marcus Welby, M.D.” or “Ben Casey” presents with odd symptoms, my father always makes what proves to be the correct diagnosis long before the first commercial break.)

But I have been an eyewitness to a number of displays of my father’s other remarkable skill as a doctor, one that mysteriously is never the focus of his storytelling: an uncommon gift for reassurance, for making his patients feel that he registers and sympathizes with their pain or discomfort and their anxieties about treatment itself; that he is really listening to them, really seeing them... (continues)==
For people with severe health anxiety, the Internet can be a terrible place
Searching online for health information can magnify the pool of potential problems to worry about, and researchers use the term “cyberchondria” to describe the interplay between health searches and health anxiety. By Emily Sohn
==
It's the birthday of the first woman to graduate from medical school, Elizabeth Blackwell, born on this day in Bristol, England, in 1821. She wanted to become a doctor because she knew that many women would rather discuss their health problems with another woman. She read medical texts and studied with doctors, but she was rejected by all the big medical schools. Finally the Geneva Medical College (which became Hobart College) in upstate New York accepted her. The faculty wasn't sure what to do with such a qualified candidate, and so they turned the decision over to the students. The male students voted unanimously to accept her. Her classmates and even professors considered many medical subjects too delicate for a woman, and didn't think she should be allowed to attend lectures on the reproductive system. But she graduated, became a doctor, and opened the New York Infirmary for Women and Children. WA Feb3
==
IACUC - Institutional Animal Care and Use Committee

The Institutional Animal Care and Use Committee (IACUC) is a regulatory body comprising MTSU faculty who are appointed by the University's President through the recommendations from the Institution's Faculty Senate. The IACUC is responsible for reviewing the activities that involve the use of animals to enforce humane & ethical practices to be adopted by the University employees. MTSU adopts the following minimum requirement for the Committee's constitution thereby complying with the requirements of both USDA and PHS...
==
Neil Gorsuch wrote the book on assisted suicide. Here’s what he said.

Not since 2006 has the Supreme Court taken up a case involving “death with dignity” legislation — the handful of state laws that allow people to end their lives with the help of a physician. That year, the court handed a victory to death with dignity advocates, ruling that the attorney general could not bar doctors in Oregon — the first state to pass such a law — from giving terminally ill patients drugs to facilitate suicide.

It was only the third time the court had heard a case challenging such statutes, and the six-member majority tread lightly, recognizing the sensitivity of the issue.

“Americans are engaged in an earnest and profound debate,” the majority wrote, quoting from a previous opinion, “about the morality, legality, and practicality of physician-assisted suicide.”

That debate is far from resolved today — and it’s one Neil Gorsuch, President Drumpf’s nominee to the high court, will surely be eager to weigh in on, should he win confirmation.

Gorsuch, a 49-year-old federal appeals court judge from Colorado, was tapped by Drumpf on Tuesday to replace Justice Antonin Scalia, who died last year after three decades on the Supreme Court. Aside from his bona fides as a lawyer and a jurist — which may all but guarantee a favorable vote in the Senate — Gorsuch has cultivated something of an expertise in assisted suicide and euthanasia in his legal career.

[Drumpf picks Colo. appeals court judge Neil Gorsuch for Supreme Court

In 2006, the year he was nominated to the federal bench, he released a heavily researched book on the subject titled “The Future of Assisted Suicide and Euthanasia.” The front cover looks almost like a Tom Clancy novel, with purple all-caps block text set against a black background. But the book itself is a deep, highly cerebral overview of the ethical and legal debate surrounding the practices... (continues)

29 comments:

  1. 1. Give an example of an experiment that violates protection as paramount
    2. What are the ethical review committees referred to in the USA?
    3. What is the therapeutic misconception?
    4. What is specisism and what does Singer equate it to?
    5. What method is used by researchers to make data more anonymous?
    6. What are two reasons scientists are lead to lie about their findings?
    7. What is fabrication?
    8. What is the difference between plagiarism and false claims to authorship?

    https://www.popsci.com/science/article/2011-01/british-doctor-faked-data-linking-vaccines-autism-and-hoped-profit-it
    Here is a Pop Science article on the doctor who lost his license after falsely reporting that vaccines lead to autism.

    ReplyDelete
    Replies
    1. 1. Nazi doctors freezing patients to death
      2. Institutional Review Boards
      3. Research participants wrongly believing participation in research will be beneficial
      4. The use of animals to determine the safety and effectiveness of products before trials are begun on human subjects; racism, sexism, and other ways of treating others in unjustifiably discriminatory ways
      5. Trusted third parties who code data
      6. Pressure to make scientific breakthroughs and to promote one’s career
      7. The invention of false data
      8. Presenting another person’s idea as though they were your own vs. requiring or allowing one’s name to appear as an author when in fact the work was entirely done by others

      Delete
  2. https://www.nytimes.com/2014/03/01/world/asia/scientists-new-project-rebuild-after-cloning-disgrace.html?rref=collection%2Ftimestopic%2FHwang%20Woo%20Suk&action=click&contentCollection=timestopics&region=stream&module=stream_unit&version=latest&contentPlacement=2&pgtype=collection

    This article is about Hwang Woo-suk's newest experiment in cloning.

    Weekly essay
    • Is the outsourcing of clinical drug trials to developing countries ethically defensible? 132
    Yes, I think outsourcing clinical drug trials is defensible. When we bring new drugs into other countries they can have both a positive or negative affect on that community. Of course, the drugs would have to be altered to commend their lifestyle so that the results won’t be skewed based on environmental factors such as exposure to sunlight, diet, or amount of strenuous activity performed. In a positive light, by outsourcing the drug could be helping people that may not have otherwise gotten healthcare. Also, if they are being closely monitored and the researchers have the patient’s best interest at heart outsourcing could be a breakthrough for some people. On the other hand, by outsourcing clinical drug trials the research could be impeding on cultural boundaries of the communities that are being tested. For example, some countries may have religious practiced that would compete with the tria.l Additionally, if something happened such as loss of funding in the middle of the trial, the participants may not get the care they need to complete the cycle. Lastly, I feel that outsourcing could increase the risk of addiction in the patients that went through the trial depending on what type of drug is being tested.

    Alternate Quiz Questions

    1.Campbell describes bad science as____
    2.What does the Helsinki Declaration Require?
    3.What are the two famous examples of epidemiological research?
    4.What criteria need to be used for consent?
    5.How does a Randomized Clinical Trial work?
    6.If you had to choose and defend one of the four R’s which one would you choose and why? How would you support your argument?


    ReplyDelete
    Replies
    1. 1. Bad science is bad ethics.
      2. The Helsinki Declaration requires that all research protocols be submitted to a research ethics committee before study can begin.
      3. The research which showed cigarettes are addictive and the cause of a whole range of major disorders and the association discovered between the pollution caused by lead in petrol and a reduction in children’s cognitive ability.
      4. That the risk to the subject is minimal, and that the research should be for the potential benefit of that patient group.
      -Joseph Churchill

      Delete
  3. https://www.sciencealert.com/scientist-claims-us-lab-engineered-humanzee-human-chimp-hybrid-100-years-ago-gallup-yerkes-oliver

    Here's the an article about the "humanzee" which seems likely to be a myth. If a human-chimp hybrid was possible, do you think it should become a reality? If the creature in the article was actually born but soon after decided to be a mistake by scientists, should it have been killed or allowed to live?

    ReplyDelete
  4. Alternative Quiz Questions:
    1. What is therapeutic misconception?
    2. What is a placebo?
    3. What book did Singer write about speciesism?
    4. What can poor genetic research result in?
    5. What are the good virtues that should be instilled in every scientist?
    6. What was the leading cause of bringing more ethical research in biomedical research?

    External Links:
    A list of the top ten transhumanist technologies.
    https://lifeboat.com/ex/transhumanist.technologies

    Discussion Question:
    Would making a "perfect" human be a disservice to the person they create?

    ReplyDelete
  5. Discussion question:
    What limits, if any, would you like to see imposed on genetic research and the uses to which it may be put?

    Of course this sort of thing needs limits, and a system of checks and balances in place to keep ethical issues in check. One such ethical issue for many (myself included), is the ability to manipulate genes to produce a child with particular phenotypes, such as enhanced cognition, eye color, physical prowess and et cetera. I think that this is wrong for a couple of reasons: for one, we are the product of millions of years of natural selection and evolution. Granted, there is currently no real evolutionary stress on us as modern day humans, maybe toying about with a highly complex system of genes for aesthetic purposes is a bad idea in terms of evolution.
    My second thought is that it's not really a fair game. I imagine only those who are considerably well off would be able to afford such treatments. Being born into poverty myself, I understand some of the disparity already in place between the poor and the rich. Given genetic manipulation, not only will I have less opportunity educationally, and monetarily; now I'm less athletic, less attractive and less intelligent than my rich brethren!
    If you've ever seen " A Knight's Tale", they speak of how a man can "change his lucky stars"...genetic manipulation would make that more of an impossibility for us poor folk.

    ReplyDelete
  6. -Joseph Churchill
    (Thank god it published. I thought it deleted my entire paragraph)

    ReplyDelete
    Replies
    1. Or it did delete. I don’t know how this works.
      Comment on Speciesism with Peter Singer
      I agree very much with Peter that the treatment of animals in the meat industry is very unjustifiable. They are given no semblance of a typical life for a living being for the reason of lowering prices on a good that I believe is a product that is very bad for our health and we should be consuming less of in the first place. I don’t believe meat should be entirely excluded from diet, but I think nutritionists, bioethicists, and doctors should encourage people more to eat less of it. A lot more. The evidence can be seen in studies done in the benefits of a whole grain, plant based diets, and comparing rates of diseases in different countries that eat different foods. In some countries, where people are too poor to purchase meat, and have a diet consisting of mainly plant based foods, the rate of death due to cardiac disorders is way down relative to Americans, as well as the number of cases of diabetes. In short, I believe meat causes many of the risk factors of disease and the main cause of our obesity epidemic, and companies are causing to increase animal suffering to produce more of it, and that is not justifiable in any way. The field of research is much to broad, and I agree with Peter Singer again in that it’s not absolute what animals should be used for in research, but they cannot be treated as a means to some minor end.

      Delete
    2. Please someone reply if you see this. I want to know if it actually worked or not.

      Delete
  7. Additional Quiz Questions:

    1. What is IRBs? What country are they located in? What is their purpose?
    2. Name all six basic requirements required to protect humans from malicious research.
    3. What is a ‘false positive’?
    4. Name four forms of misconduct in research.
    5. How can you find more information about the US Public Health Service and its regulations?

    ReplyDelete
  8. Alternate Quiz Questions

    1. What are Institutuonal Review Boards?
    2. What question can you ask to determine the worth of research?
    3. Define therapeutic misconception.
    4. What has been a solution to researchers dealing with incidental findings?
    5. How are patients divided in randomized clinical trials?
    6. What is clinical equipoise?
    7. Describe the welfarist approach.
    8. What is genetic exceptionalism?
    9. What is the transhumanist movement?

    ReplyDelete
  9. Alternate quiz questions:

    1.) What, in your own opinion constitutes consent.
    2.) What does "Bioethics the basics" consider consent? Do you agree or disagree? Why
    3.) What are the major ethical issues "Bioethics the basics" describes in terms of genetic manipulation?
    4.) Is it ethical to prescribe medications to children for so called "behavioral issues", knowing that some of these classes of drugs alter brain chemistry. The alteration of brain chemistry is a region of science that remains the subject of current research, and so, it could be said we are unable to quantify any real damages that may be done.

    ReplyDelete
  10. Alternative Quiz Questions:
    1.what is RCT?
    2.Define placebo?
    3.What do those advocate animal liberation argue?
    4.what can poor genetic research result in?
    5.Epidemiological research depends on seeing assiociations between large banks of data gathered over extended periods of time. Name two famous examples of this.
    6.what is Falsification?

    ReplyDelete
  11. Extra quiz questions:
    1. What does the welfarist approach means?
    2. What is genetic exceptionalism mean?
    3. What is the transhumanist movement?
    4. In what year did the WHO Ad Hoc Committee on Health Research reported a 10/90 gap?

    ReplyDelete
  12. Alternative quiz questions:
    1. what does IRB's stand for?
    2. What does the therapeutic misconception mean?
    3. What does the RCT stand for?
    4. Define clinical equipoise?
    5. What is the specialism mean?

    ReplyDelete
  13. This is an interesting article about the lung transplant allocation system and how where you sign up impacts how quickly you will get a transplant, regardless of how badly you need one:

    https://www.sciencedaily.com/releases/2018/12/181217105858.htm

    ReplyDelete
  14. Extra Quiz Questions:
    1) What are some of the factors in the 10/90 gap?

    2)What are some risks in genetic research, particularly to ethnic groups?


    3) Campbell offers what opposition to advocates of animal liberation?


    4)What are the guidelines in combating 'incidental findings'


    5)What groups have been associated with writing the international norms we see in research today?


    6)What are some causes of scientifically flawed research?


    7)What are the ethical review committees in the US called?


    8)What areas of research would be stifled if they were to follow the Nuremburg Code, Clause 1?

    ReplyDelete
  15. Remind us to go over the alt questions in class.

    ReplyDelete
  16. Alt quiz questions:
    1. According to the Helsinki Declaration, what must take precedence over all other interests regarding scientific research?

    2. What is an instance of Therapeutic Misconception?

    3. What is a "Double Blind" experiment

    4. Why is a "Double Blind" experiment more likely to produce scientifically valid results?

    5. How would a Buddhist and a Utilitarian disagree fundamentally concerning animal experimentation for human benefit?

    6. Define "Genetic Exceptionalism"

    7. What form of research misconduct would you have performed if you invented data to prove your hypothesis?

    8. What form of research misconduct would you have performed if you claimed another person's ideas as your own?

    9. What United States federal agency investigates research misconduct and who sponsors this agency?

    ReplyDelete
    Replies
    1. 3. Neither the researchers or participants know which group (placebo or experimental) any given participant belongs to.
      5. Buddhists-respect for life, Utilitarian'- sacrifice for the ultimate good

      Delete
  17. I honestly dont think there is ever a truly informed consent as there are too many chances for something unknown yo happen in an experiment and there is. O way to account for every possibility.

    ReplyDelete
  18. When it comes to experimenting on other species, I have a conflicted view. I personally believe that all life is precious and has its own purpose in the world and should be preserved. But, I realize the importance of needing a subject to text on in order for the betterment of the human race. I just wish we could find a better way than to use animals in the future.

    ReplyDelete
  19. 1. What do trusted third parties do?
    2. What is one of Campbell's listed resources for "animals in research?
    3. What is the implication if one has the warrior gene?
    4. What is a "me too" drug?
    5. Define Placebo.
    6. For what reason is the Titanic referenced in the chapter?

    ReplyDelete
    Replies

    1. 3. Aggression
      4. Drugs created to ensure the securing of a patent and are usually similar to patented medication. An attempt to "jump someone else's train."
      5. A dummy drug, given in an experimental trial, which has no therapeutic qualities.

      Delete
  20. DQ:

    Do you guys think that Dr. Jiankiu will infamously go down in history like Dr. Woo-suk, if his allegations prove to be false?
    Would the 10/90 gap be repairable strictly through economic policy reform?
    Is every aspect of human enhancement at least a little bit, if not fully a basic form of transhumanism?
    If the goal of transhumanism is reached, does that make us a new species or organism, or are we still people?

    ReplyDelete
    Replies
    1. Regarding transhumanism, posthumanism seems to be the end goal. The incorporation of nanotechnology or other enhancement would make us cyborgs, or what not. The second desire of this movement seems to be uploading consciousness to some kind of data system e.g, "the cloud." I think this would make us something beyond people, certainly,

      Delete