Alzheimer's Disease, Advance Directive and Feeding

Back on October 29, 2005, I wrote a post describing an elderly Alzheimer's patient with no other medical complications and who was aware of her environment but who years earlier when she had the mental capacity to make decision stated that she didn't want medical nutrition and hydration. A feeding tube was placed a few years earlier because of difficulty swallowing during a prolonged respiratory infection, with the intention that it would be temporary but the feeding tube still remained in the patient. The issue was whether removal of the tube now would contribute to her death and whether it should be removed.

On this current post, I would like my visitors to consider an elderly Alzheimer's disease patient who appeared to the caregivers that she was really not aware of her environment except when food or liquid is placed between her lips she appears to accept the feeding and swallows. The ethical issue is that years ago when she had capacity to make medical decisions she wrote in an advance directive that if she had an irreversible disorder that left her unaware of her family or others and couldn't care for herself, she would not want to be fed and should be allowed to die. She is tolerating oral feedings but should they be stopped in view of her past directive?

The ethical issue in both cases is whether if a patient rejects food and fluid by tube or even by mouth under some stated conditions in an earlier advance directive, should that request be followed? Should the patient's prior directive against being give nutrition be questioned either by trying to communicate with the demented person or by following the decision of a current legal surrogate? Should there be a difference between feeding a patient by tube or feeding the patient orally, if the patient doesn't resist the feeding? If a patient in end-stage Alzheimer's now appears to accept food and fluid orally, should that behavior trump any previous directive to the contrary? Is the currently demented person the same person (in terms of personhood) who signed the original advance directive? If not, should the advance directive be ignored?

Has any of my visitors had similar issues arise in the management of their own family member with Alzheimer's? ..Maurice.

Should Early Prediction of a Personal and Family Quality of Life Disaster Lead One to Consider Suicide?

If scientific research can lead to tests which can predict that years ahead an individual will develop symptoms of quality of life destructive disease and one that is currently unpreventable and untreatable, should that individual plan now how to cope with the prediction? For example, should the individual seriously consider ending his or her life prematurely through suicide at some point rather than awaiting suffering and loss of any acceptable quality of one’s life?

One example is predictive testing for Alzheimer’s disease. Parens and Johnson writing in TIME set a social duty now to consider the pros and cons of suicide or assisted suicide decisions made by individuals prior to becoming severely symptomatic with diseases such as Alzheimer’s. They write:

“It is time to listen to and take seriously those people who, upon seeing their own parents spend years, even decades, suffering with Alzheimer's, say that they refuse to expose their partner or children to the same. We cannot ignore competent people who say they would rather die than no longer recognize their children or the partner with whom they built a life. Nor should we dismiss those who say that they can't themselves afford to pay for years of nursing home care, don't want their children saddled with that expense, or would rather that the money be used for their grandchildren's education.

When it becomes possible to detect Alzheimer's disease before it has progressed, these arguments will no longer be academic. The question for our society, including our legal system, medical practitioners, religious institutions and patient support groups, is whether we will dismiss those who make these arguments as depressed and misguided or whether we will engage with them on their terms.”

Well, what do you think? Can you begin a societal discussion about the rational planning of suicide in the face of early prediction of a disease such as Alzheimer’s? ..Maurice.

Want to Do Hospital Committee Ethics? (1): Withdrawal of MNH

This scenario will be the first in a series of scenarios that are examples of what hospital ethics committees experience. One of the roles of ethics committee members is to come to a consensus and inform the stakeholders about the ethics and the current law regarding the issue and anticipated action.

For this exercise to be of interest and worthwhile, it will require my visitors reading the scenario to contribute their comments regarding the issue. Remember, you don’t have to be a professional ethicist to give an opinion; you just have to be an interested member of society.

FACTS:
94-year-old Catholic woman with advanced Alzheimer’s Disease,
5-year resident of a Catholic care facility.
A feeding tube to provide medical nutrition and hydration (MNH) was placed a few years ago because of difficulty swallowing during a prolonged respiratory infection, with the intention that it would be temporary but the feeding tube still remains in the patient. It is not clear why the tube was left in place but, perhaps, it was providing good nutrition without complications and was more efficient for the nurses.
The patient now has moderately severe trouble swallowing attributed to Alzheimer’s..
The patient has no terminal illness. She has only severe Alzheimer’s yet is still aware of her environment.
Years ago, while mentally competent the patient prepared an Advance Directive stating that she did not want medical nutrition and hydration(MNH).
The family wishes to have the feeding tube removed.
There has been no recent change in the patient’s condition.

THE ISSUES:
Should the feeding tube be removed now from the patient? Is the intention of removal of the tube a decision to end the patient’s life, if she can’t be adequately given oral food and fluid or is the decision to relieve the patient of an extraordinary burden imposed by the tube. Should the physician be compelled to have the tube removed even if the physician, for moral and religious reasons, does not want to write an order for this act?
What if the nurses refuse to follow an order to have the tube removed?
Would it make any difference in the analysis of the issue if the patient was NOT Catholic and was a resident in a NON-CATHOLIC care facility?

DECISIONS: Now it is up to you my dear visitors to tell us all your opinions. ..Maurice.

Who is the Patient?

One may wonder, why the question “Who is the Patient?” Surely, the healthcare worker knows the answer when confronted with an ill person. But, in practice and ethically, the answer may not be so simple or well established. Take for example the young child who is too immature to be competent to understand and make decisions for him/herself. It is the parents who give the clinician the history and are responsible to care for the child. They are the ones sufficiently aware of the nature of the illness to suffer the emotional and financial consequences of their experience with their child and the knowledge of the illness and prognosis. Many pediatricians look to the family and child together as the “patient” and must evaluate and make treatment recommendations accordingly. Here, because the child is not competent, the autonomy rests with the parents.

Another example where the family is considered as the extended patient is in end-of-life hospice care. During the period when the patient is dying, it is often the family who has the potential for suffering, perhaps not in the same way as their ill family member, but suffering non-the-less. Those attending to the needs of the ill person must also attend to the needs of the family. A more prolonged scenario where the family and ill person become clinically integrated would be in Alzheimer’s disease. With Alzheimer’s the family may expend much finances, physical work and emotional attachment involved in the many years of responsibility for care. Other psychiatric illnesses may have similar family involvement but also there may be specific familial dysfunction, which directly contributed to the illness. Again, in these scenarios, the healthcare worker ideally should attend to the family in conjunction with management of the ill person.

In dealing with illness within some cultures, such as American Indians, for example, it is the family or the tribal group who takes the full responsibility for understanding and medical decision-making and thus have been looked upon as the “patient”. In all these examples of adult illness, what has happened to the ill person's autonomy?

As a final example here, genetic counselors consider the family as the patient and must determine why family members seek counseling, not just the person affected or potentially affected with the genetic disease.

Some sociologists and ethicists might even consider society to be included as the patient since it is felt that the physician should consider, in terms of the principle of justice, the effect of their management on, for example, the resources available to others.

The challenge to the practice of medicine by redefining and extending the concept of the patient to include the family and beyond is that it is also extending the limits of the medical responsibility of the physician. For example, while a procedure or treatment may not be medically appropriate for the ill person, if administered for the “whole patient” it could be argued that it might provide some emotional benefit and support for the family component.

Where do you think that a physician’s or other healthcare worker’s responsibility ends? With the ill person? Or with the family or even society? The philosopher Hans Jonas in 1969 had the answer: "the physician is obligated to the patient and to no one else .... We may speak of a sacred trust; strictly by its terms, the doctor is, as it were, alone with his patient and God." But,again, I ask "Who is the Patient?" ..Maurice.

Pharmaceutical Testing in the Incompetent Patient

The issue of the ethics involved in the pharmaceutical testing of the mentally incompetent patient (one who does not have the capacity to make medical decisions for himself or herself) was presented on my now inactive "Bioethics Discussion Pages". As with other topics on the "Pages", I would like to migrate them here to the blog and read what my current visitors might comment on them.

I recently got an e-mail from L.R. Booth (boteone@yahoo.com) who does not believe any surrogate has the right to make a decision for a mentally ill patient to participate in a drug experiment and believes that there are patients who could eventually make their own decision. He writes:

" I do not feel you can use the terms incompetent and mentally ill interchangeably. Someone who is incompetent cannot give consent, therefore, it is unethical.
I do not believe anyone has the right to make that decision for the Pt. It's a shame that too many DPOA's and legal guardians do not have the Pt.'s best interests at heart. If the Pt. has outlined this tx in the form of a Advanced Directive then it would be ethical. If someone is suffering from a mental illness that does not mean they are incompetent. Mental illness includes a wide variety of disease processes; depression, bi-polar etc. If treated properly these Pt.'s can make a informed decision on experimental drug txs"

I should explain my understanding of mental illness and capacity to make medical decision. Not every mentally ill patient has lost capacity to make their own medical decision. The loss of capacity must be determined by careful testing by the physician. It can be done successfully. A patient can have the capacity to make a medical decision in one context and not in another, so the testing should include the context in which the patient may be involved. Does the patient understand what drugs are and what they do, for what they are used, by whom and how drugs are developed and how they are tested, for what are they tested and upon whom they are tested? Does the patient understand that the patient might not get to take the drug that is being tested and might get another drug or a sugar pill? Does the patient understand that the drug being investigated might not be any more useful than a sugar pill or another drug? Does the patient understand that the patient might suffer complications from the testing either by bad effects of the drug or by the fact that their usual medication may have to be discontinued? If the patient passes all these questions by demonstrating understanding, then I would think the patient would have the mental capacity to make their own self-decision whether or not to participate in the study regardless of their established psychiatric diagnosis. For those who have no capacity to understand and give consent, the main question of this post is whether someone else should. But unlike surrogates giving consent for treatments that are not experimental and are known to be effective, balanced against the risks, in the case of experimental drugs tha effectiveness is unknown and the risks may only be partially known. Is the altruistic properties of being a subject in a test that might help oneself and many others sufficient to override the inability of the patient to understand and agree with the surrogate's decision?

In the comments below, the oldest replies are at the bottom of the posting. ..Maurice.




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Pharmaceutical companies must test new drugs for the treatment of mental illness on patients with the illnesses for which the drugs were developed to treat. This seems a very clear statement. The ethical concern is how can these patients who may have lost the capacity to understand the purpose, nature, risks, benefits and alternatives (including nonparticipation) of the research, to make a decision about participation? Should a family member or other surrogate make the decision for such a patient? Ordinarily, surrogate medical decisions deal with therapeutic issues. In the case of drug testing, the testing itself may not prove to be therapeutic, may be painful or even harmful for the patient. Should surrogates be given the power to allow the patient to be subjected to medications which have not been proven therapeutic but may be harmful? If there is no surrogate, who should make the decision or should the patient be eliminated as a candidate for the study?


Here are the questions:

How can the patient's rights be protected and still provide for necessary testing of drugs in the mentally ill? Who, if anyone, should make the decision for an incompetent patient regarding participation in a drug testing experiment?







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Date: Tue, Mar 9, 2004 7:06 PM From: khmaio@earthlink.net To: DoktorMo@aol.com
Please do not employ the term, "the" mentally ill. No group is generic.How to obtain informed consent when a person is not capable of giving it? Stop.If I know someone is not competent, proceeding is unethical. Only greed motivates past knowing the person cannot consent. The greed for an answer or for a recognition.More the latter than the former. Harold A. Maio


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Date: Wed, Jan 21, 2004 11:20 AM From: khmaio@earthlink.net To: DoktorMo@aol.com
How can the patient's rights be protected and still provide for necessary testing of drugs in the mentally ill? Who, if anyone, should make the decision for an incompetent patient regarding participation in a drug testing experiment?

There is no generic "the" mentally ill. There is however a commodity, "the" mentally ill, which is widely exploited. There have been many such "commodities" in history. Once one has retreated to an abstract "the", societies seem to offer that group to be expolited. Generally the exploited group has no political power, ergo the Tuskegee "study". Even the Salk vaccine was tested on people unable to consent.

If one is a "patient" are there not already ethics in place, or is the term just a convenient empty metaphor?

Should a person unable to consent be forced to participate? No. Whatever term someone wishes to employ, it amounts to force since consent cannot be obtained. Florida law accepts that infomed consent has been obtained when "sufficient" explanation has been given. "Sufficient" is a metaphor of force, since it will be defined by the person intent on forcing, not by the person forced.

Harold A. Maio,Consulting Editor Psychiatric Rehabilitation Journal Boston University


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Date: Tue, Apr 8, 2003 3:52 PM From: bpspiper@msn.com To: DoktorMo@aol.com
I believe that it is wrong to conduct experimental testing for unapproved drugs on the mentally ill without express consent from a legal guardian, power of attorney, or judgment of the state. As a nursing student we have been taught that our highest priority is to protect the rights of our patients. Through education we can help the families and guardians come to a better understanding of how pharmaceutical companies work to improve and or create new drugs that could better serve the people. With this education now comes the power of the families and guardians to decide what is in the best interest of the patient. We cannot arbitrarily stand by while others decide our fate. We have to stand up for the rights of those who cannot stand up for themselves. If we don't who will stand up for us if the time comes?

Becki Price


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Date: Mon, Oct 22, 2001 8:52 AM From: CBlades@JPMC.ORG To: DoktorMo@aol.com
Not all mentally ill people are incompetent. I think that has to be determined before you can make a blanket statement as to who can make the decision for their participation in a drug trial. Many mentally ill patients would welcome the chance even during stable periods, if it meant decreasing the effects that their illness has on their lives. Look at the Clozaril trials for instance...while there are great risks associated with this medication the benefits for the majority of the patients outweighed the risk. I believe we allow the patient to make the choice unless the court has declared them incompetent and if that is the case, give the information to the legal guardian and assist them in make the appropriate decision as needed.


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Date: Thu, Jan 11, 2001 5:46 PM From: mlammers3@home.com To: DoktorMo@aol.com
Using experimental drugs on persons who are mentally incompetent because of illness is not a clear cut issue. However, if the drugs are being designed to specifically treat their disease or disorder, and this disease or disorder often or always leads to mental incompetence, the treating physicians are really left with no choice but to test the drugs on these people. Certainly the drugs cannot be used on healthy people. I think the decision of whether or not these patients should be used in experimental drug testing should be left up to their relatives, who will hopefully act in the best interest of the patient.


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Date: Tue, May 19, 1998 3:44 PM From: sheilac@kalama.doe.Hawaii.Edu To: DoktorMo@aol.com
Pharmaceutical testing in the incompetent patients? This is a really tough issue. It's like a gamble, you test the drug on a person like a guinea pig, if it lives and does its purpose it works, but if the patient gets worse or dies it's a failure and you loose. I say let a family member make the decision for him or her. Discuss the drugs purpose and whats expected to happen, Also explain it's risk and possible side effects. Also explain what the patient may feel physically and mentally.


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Date: Sat, Jul 26, 1997 1:35 PM From: DocReading@sprintmail.com To: DoktorMo@aol.com
Mentally ill patients are not by definition incompetent to consent to drug testing. Many mentally ill patients do not lack the capacity to understand the purpose, nature, risks, benefits, and alternatives of the research. As a matter of fact, I have many patients (I am a Psychiatrist) who are more altruistic than their non-mentally ill designated counterparts. If a drug can be tested on willing and factually competent individuals, it should. Only if it can be proved that an illness renders all people who contract it incompetent to consent then legislation could be enacted to appoint a committee to decide based on the individual's premorbid preferences if possible whether or not to allow the person into the study. The principle of autonomy should rule whenever possible.


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Date: Wed, Apr 16, 1997 2:41 AM From: gottlieb@hp380.ist.unige.it (Prof. Alberto Gottlieb) To: DoktorMo@aol.com
The problem of consent to diagnostic and therapeutic procedures of incompetent individuals has not yet been solved adequately and you already ask about the consent relative to experimental therapy ?! It seems evident that caring for, let's say, a demented Alzheimer patient is quite easy when benefits prevail over risks by far :e.g.in case of arterial hypertension or acute appendicitis. If, on the contrary, performing diagnostic and therapeutic procedure entails a certain morbidity (annoying side effects) or mortality e.g. coronary disease, then every person deciding for the incompetent patient will be criticized , and perhaps also legally sued by relatives with conflicting interests , if things don't go straight. Deciding about new diagnostic or therapeutical procedures (namely drugs) to be applied in incompetent patients should start from the same point: the benefits either real or awaited (on serious scientific grounds)should prevail by far over risks. It must brought in mind however that only at the beginning of the dementing process, such as Alzheimer or Multiinfarctual dementia, a real benefit may be awaited from a therapy and it will be, when it will be, a stop to mental deterioration. It seems actually unbelievable to restore mental abilities that have been lost because the corresponding neuronal centers are atrophic and millions of neural cells and their fibers are absent. This stimulates drug researchers to focalize their efforts on the beginning of the dementia when the best resuls are perhaps attainable and, if attained, best measurable. But it is just the moment when patients usually are still competent and may be asked their consent about new drug treatments. I think morevover that in this period of initial restriction of mental capacity which does not intefere yet with the ability of caring about theirselves patients may be asked advanced directives about the future behaviors of the caregivers (deciding substitute) and the medical staff.


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Date: Thu, Dec 19, 1996 2:43 AM EDT From: BBrodie960@aol.com To: DoktorMo@aol.com
Society provides a surrogate decision maker for its immature and mentally incompetent members. To an extent, the rights of this unfortunate class are transferred to those close enough to them to act in a manner as similar as possible to the incompetent person. Usually, this is a family member, but it might be a friend, or even the state when that's the best society can come up with. It's not a perfect system, but more often than not, the designated decision maker acts in the incompetent individual's best interest and in a way that is reasonably similar to the way that individual would act if he or she were competent.

I think the testing of psychotropic drugs is so important that the risk of unnecessarily violating a person's right to make an informed decision is significantly outweighed by the benefit of making appropriately tested and effective drugs available to those who need them. (Not only does the mentally ill patient benefit from the drug, but society benefits from him or her taking the drug.)

I say, let the party designated to make any important healthcare decision on behalf ot the incompetent individual make the decision regarding participation in a drug study. The only exception I would make to this rule would be when the incompetent individual's guardian is the state because the state is least likely to know how the incompetent individual would act if he or she were competent.


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Medical Advance Directive: An Emphatic "NO!" to Dementia

Norman Cantor, a lawyer and Professor of Law at Rutgers University School of Law wrote a thoughtful article about the medical Advance Directive in the Harvard Law School "Bill of Health" blog

http://blogs.harvard.edu/billofhealth/2017/04/20/changing-the-paradigm-of-advance-directives/

and explaining why he is revising his own medical Advance Directive to instruct his physicians and caretakers to allow him to die if he had developed a dementia "upon reaching a degree of permanent mental dysfunction that I deem to be intolerably demeaning.  For me, this means mental deterioration to a point when I can no longer read and understand written material such as a newspaper or financial records such as a checkbook"

Read his entire presentation at the Harvard Law blog link above and then return to present your views on adding profound mental deterioration to the list of physical illnesses which are irreversible and can be highly distressful to the patient and his family's lives and which he does not want to experience or have his family experience further and if he should face a treatable but serious life threatening condition, he should be allowed to die.

Hopefully, all of my blog readers have their own medical Advance Directive written to designate  a  surrogate to attend to their wishes for treatment of a potentially fatal illness when it occurs. If not, as your physician moderator of this bioethics blog, I would strongly recommend it be created and available for your physicians later to read and observe your directive.

  With Professor Cantor's permission, his Revised Advance Directive is reproduced below. ..Maurice..                                                       

My Revised Advance Directive

     I have witnessed the ravages that Alzheimer's disease and similar progressive dementias produce.  I wish to be allowed to die upon reaching a degree of permanent mental dysfunction that I deem to be intolerably demeaning.  For me, this means mental deterioration to a point when I can no longer read and understand written material such as a newspaper or financial records such as a checkbook.       

     This wish to hasten my post-competence demise is not based on prospective suffering or distress, but rather on my personal vision of intolerable indignity and degradation associated with cognitive dysfunction.  For me, it is critical to shape the post-mortem recollections of my loved ones and to preserve the lifetime image as a vital, critically thinking individual that I have strived to cultivate.  In addition, it is important to me to avoid being an emotional, physical, or financial burden on my family and friends, even if they would willingly assume such burdens. 

    I fully understand that my determination to avoid prolonged, progressive debilitation could prompt my demise even though I might appear content in my debilitated condition.  I am exercising my prerogatives of self-determination and bodily integrity to shape my lifetime narrative, including my dying process, in accord with my strong aversions to mental dysfunction and to dependence on others. 

     My determination not to prolong my life at the described point of debilitation includes rejection of any and all life-sustaining means.  This includes simplistic medical interventions such as antibiotics, blood transfusions, and antiarrythmics, as well as more complex interventions like CPR, mechanical ventilation, dialysis, and artificial nutrition and hydration.  Indeed, if my dementia or any other affliction has produced inability or unwillingness to feed myself – for example, because of swallowing difficulties, or other eating disorders, or just indifference to eating -- I instruct that my caregivers refrain from hand feeding unless I appear receptive to eating and drinking (show signs of enjoyment or positive anticipation).  If I am indifferent or resistant to hand feeding, I do not want to be cajoled, harassed, or in any way impelled to eat or drink.   

     The only limitation on my advance rejection of life-sustaining medical intervention is adherence to humane treatment.  That is, I have no desire to subject my future incompetent persona to a torturous or agonizing dying process.  I presume that palliative steps -- including medication for pain, anxiety, or agitation -- will be taken to ease my dying process. 

     The question may arise as to whether I have had a change of mind and revoked my advance directive.  My wish is that no revocation be found unless I do so while still capable of a considered choice, including appreciation of all the major elements involved.  I urge my decision-making agents to avoid the temptation of manipulating my future, incompetent persona to contradict or alter my advance instructions.  And I direct that my original instructions be honored absent an aware, considered change of mind (as opposed to uncomprehending expressions by my demented persona). 

Graphic: Through Google Images. "5th Dementia"PAINTING BY JEFF BOWERING Saatchi Art

More on the Mentally Ill:King Lear and the Madness

fear I am not in my perfect mind.
Methinks I should know you and know this man;
Yet, I am doubtful; for I am mainly ignorant
What place this is; and all the skill I have
Remembers not these garments; nor I know not
Where I did lodge last night. Do not laugh at me.
(William Shakespeare (1605) King Lear, Act IV, Scene 7)

As an extension to my recent threads on how informed consent should be obtained in pharmaceutical experiments on the mentally ill and whether the mentally ill should be given assisted suicide, I wanted to include a posting about a classic example of mental illness in literature, Shakespeare's King Lear, and how mental illness was explained long ago and how it was treated. Did King Lear have Alzheimer's Disease or some other psychiatric illness? Whichever, it was a therapeutic challenge then and today in many ways it is still a challenge.

The following is an essay on King Lear, his madness and how mental illness was evaluated in the Renaissance period. I obtained it from John Mark Ministries

(Note: I took the above photograph of the painting of King Lear and Cordelia by Benjamin West today at the Huntington Library and Botanic Gardens, San Marino, CA). ..Maurice.

Renaissance Views of Madness: King Lear
By Adrian Ingham, December 1996

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The essay that follows was researched and written by Adrian Ingham as part of the course on Shakespeare by Individual Studies, 1996; it is reprinted here with his permission. While copyright is retained by Adrian Ingham, this material may freely be used for educational and non-profit purposes, so long as the author and source are cited.

Samuel Johnson describes the age of Shakespeare as a time when "speculation had not yet attempted to analyze the mind" (118), but there was a range of theories and opinions regarding madness. And although it has been demonstrated that Shakespeare's portrayal of madness parallels Bright's A Treatise of Melancholie (Wilson 309-20), that medical model alone is insufficient to describe the madness of King Lear. Shakespeare was not limited to a single book in his understanding of madness; he had at his disposal the sum total of his society's understanding of the issue. Since Lear's madness is derived from a mixture of sources, it can only be effectively described in this larger context.
Because much of Renaissance medical theory was based on premises from the Middle Ages, a starting point for our understanding of Lear's madness can be found in the 1535 translation of De Propriatibus Rerum by the thirteenth century monk Batholomaeus Anglicus. This work is based entirely on the traditional model of illness as an imbalance of the four humours: melancholy (or black bile), choler (or yellow bile), blood, and phlegm. Batholomaeus classifies melancholy and madness separately, attributing them to different humours and different areas of the brain (1-4). The condition of melancholy is caused by an excess of the melancholy humour. It makes a person "ferefull without cause, & oft sorry. And that is through the melancholi humor that constreineth & closeth the herte" (2). In extreme cases melancholy causes symptoms quite like madness, "somme fall into evyll suspections without recover: & therfore they hate - blame, and confounde theyr frendes, and sometyme they smyte and slee them" (2). But although Lear could be described as falling into "evyll suspections" he probably does not have melancholy. He is choleric by nature and it is likely that his madness is caused by an excess of that humour. Goneril describes his choler and foreshadows his madness in an early attempt to discredit him:

The best and soundest of his time hath been but rash; then must we look from his age to recieve, not alone the imperfections of long-engraffed condition, but therewithal the unruly waywardness that infirm and choleric years bring with them. (1.2.294-298)
In Bartholomeus' model madness caused by an excess of choler is called "the frenesie". Its signs are "woodnes and contynual wakynge, mevynge and castynge aboute the eyen, ragynge..." (3). It is caused by the red choler "made lyght with heate of it self... ravysshyd upwarde by veynes, synewes, wosen and pypes" (2). The cure involves bleeding the patient, shaving his head and applying vinegar and ointment to the head. However it also recommends creating a calm environment for the patient, feeding him a sparse simple diet, and "above all things... men shall labour to bringe hym a slepe" (3-4). Kent seems to be aware of this most important part of the cure, and through him we realize that Lear's madness may have been shortlived had he been able to rest before fleeing to Dover:

Oppressed nature sleeps.
This rest might yet have balmed thy broken sinews,
Which, if convenience will not allow,
Stand in hard cure. (3.6.94-98)

However, not all contemporary models of madness relied solely on humours. Timothy Bright's model simplifies Bartholomeus' categorization of madness by calling all madness melancholy, but diversifies it by distinguishing two separate types of melancholy. In Brights words: "the difference is betwixt natural melancholie, and that heavy hande of God upon the afflicted conscience, tormented with remorse of sinne, & fear of his judgement" (37). Natural melancholy resembles Bartholomeus' model in that it has humoreal origins and in its extreme manifestation the melancholy humour can cause "stormes of outrageous love, hatred, hope or feare, wherewith bodies so passionate are here and there, tossed with disquiet..." (Bright 38). But unnatural melancholy has no parallel in the medieval model. Natural melancholy can be recognized from the general symptoms of madness occurring in a stable person in a stress free environment. In this case the madness can only be attributed to physical imbalances (38), while unnatural melancholy, ironically, can be recognized by its occurrence in situations when it seems more natural to go mad: situations in which the mind is tormented by worry and stress (37). The natural/unnatural distinction should not be taken to imply rarity or probability but rather physical or non-physical causes. In Bright's model, like Bartholomeus', Lear would probably not be diagnosed with natural melancholy. We have seen that he is naturally choleric rather than melancholic, and he certainly has recognizable cause to go mad from mental stress and guilt, as Kent, once again, recognizes:

A sovereign shame so elbows him: his own unkindness That stripped her from his benediction, turned her To foreign casualties, gave her dear rights To his dog-hearted daughters -- these things sting His mind so venomously.... (4.3.44-49)

And because Lear is suffering from unnatural melancholy, his prognosis is not good in Bright's model: "Here no medicine, no purgation, no cordiall, no tryacle or balme are able to assure the afflicted soule and trembling heart, now panting under the terrors of God" (39-40). So we see that mere rest may not have been enough to cure Lear's condition. Upon his reconciliation with Cordelia it is rest which calms his anger, but it is her forgiveness which brings him out of his depression. Had Lear not been parted from her again through her death he may well have survived his madness.
Had Lear survived, however, it would not have been to recover his former self. Lear's madness is a journey as much as it is an illness. Even in his brief interlude of lucidity before Cordelia's death he is a different man:

When thou dost ask me blessing, I'll kneel down And ask of thee forgiveness. So we'll live, And pray, and sing, and tell old tales, and laugh At gilded butterflies, and hear poor rogues Talk of court news... (5.3.10-14)

This humble speech to Cordelia is in reaction to the affront of losing a war and being led to prison; compare it to Lear's reaction to friendly advice from the Earl of Kent at the beginning of the play:

Hear me, recreant, On thine allegiance, hear me! That thou hast sought to make us break our vow -- Which we durst never yet -- and with strained pride To come betwixt our sentence and our power -- Which nor our nature nor our place can bear... (1.1.166-71)

Through his madness Lear breaks down the false illusions of his courtly world. Where the earlier speech is concerned with power and title, the later speech is concerned with humanity and friendship. Lear's madness can be seen both as a result of his arrogance and as a remedy for it: "Lear's experience is purgatorial; madness is both punishment and insight" (Byrd 7). The Fool's statement that "truth's a dog must to kennel; he must be whipped out" (1.4.111-12) foreshadows the pain that Lear will have to pass through before attaining enlightenment. This vision of madness is characteristic of Shakespeare's era. The Renaissance held the Aristotelian view that there is a fine line between madness and divine inspiration (Skultans 20), but by the eighteenth century madness was viewed as no more than degradation and shame. In testimony to this, the eighteenth century's favorite version of King Lear was a version rewritten by Nahum Tate to include a happy ending (Byrd 7-8). In this version Lear recovers from his illness, wins the battle and reigns again: by suffering madness Lear pays for his sins and is returned to health and prosperity. In contrast to this, Lear's transformation in the original play leaves him so guileless that it is unlikely that he would survive long with the intrigues of running a kingdom even if he had won the war. When Lear dies it is because he has finally learned to love; and when the one he loves dies, the intensity of his sorrow kills him. "His death is a release from suffering, but also a testimony to what he has become" (Byrd 8).
Thus Lear's madness transcends a purely medical model. Lear is a fusion of not only Bright and his predecessors, but also of Renaissance feelings towards madness. The medical model had not changed significantly by the eighteenth century, but common opinions about madness had. The fact that Tate's maudlin happy ending was ever preferred to Shakespeare's original is testimony to the difference that such attitudes can make. While the similarities between Shakespeare's mad men and Timothy Bright's A Treatise of Melancholie are evident, it would be a mistake to infer from these parallels that the characters are based solely on that model. They are, instead, derived from both medical and non-medical sources, and they can be most effectively analyzed using a simular variety of sources.


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Works cited
Bartholomaeus Anglicus. De Proprietatibus Rerum. Qtd. in Hunter 1-4.
Bright, Timothy. A Treatise of Melancholie. Hunter 36-37.
Byrd, Max. Visits to Bedlam: Madness and Literature in the Eighteenth Century. Columbia: U of South Carolina P, 1974.
Hunter, Richard, and Ida MacAlpine, eds. Three Hundred Years of Psychiatry 1535-1860: a History Presented in Selected English Texts. London: Oxford UP, 1963.
Johnson, Samuel. "Preface." Johnson on Shakespeare. Ed. R. W. Desai. New Delhi: Orient, 1985.
Shakespeare, William. "King Lear." William Shakespeare: the Tragedies, the Poems. Ed. John D. Wilson. Cambridge: Cambridge UP, 1986.
Skultans, Vieda. English Madness: Ideas on Insanity, 1580-1890. London: Routledge, 1979.
Wilson, J. Dover. What Happens in Hamlet. Cambridge: Cambridge UP, 1967.

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"No.. Not Yet":Answering the Patient's Request for "Off Label Use" of a Drug

In the United States, physicians can legally write a prescription for a drug to be administered to a patient with a disease not approved by the Food and Drug Administration (FDA) for use, so-called "off label use" if that drug has already been approved for use by the FDA  for some other disease.  Often, patients and their families faced with a serious disease and unresponsive to any beneficial action by the available drugs for that condition may, after learning from the media of "promising results" from preliminary drug studies for that disease insist that their physicians prescribe that drug.  The "promising results" may be more supposition based on elementary animal studies of the patient's disease and not as yet studied in humans with that disease.  Yet, such "results" are readily documented by the media and thus available for the public to consider and desire.

Physicians practice under the ethical obligations of their profession to be beneficent in their actions with the patient and to avoid harm.  Such beneficence would include to attempt to attain a goal of "cure" for the patient's disease.  But what if the "cure", at present, was only theoretical and not documented by valid testing in humans?  To "avoid harm" is another matter of concern since if approval of the drug was carried out in studies or experience with a disease other than that experiencing by the current patient, can the physician be sure that the drug will be equally safe?

The ethical issue is how should a physician respond to a vigorous and understandable request by a patient or family member for the doctor to prescribe a drug as "off label" for a critical illness, not responding to prior drugs, but a drug which has not been approved by the FDA for such use and whose benefit/safety value for that disease has not been proven but only suggested by the media?

Should what is read by the public on a website or newspaper or heard on TV be something to challenge the doctor?  And does the doctor have the time, knowledge and ethical strength to defend any refusal to follow the request and finally say "no.. not yet."  Or at a certain end-point of an illness, the refusal itself is unethical?   ..Maurice.

p.s.- For more on this topic: "The Ethics of Early Evidence---Preparing for a Possible Breakthrough in Alzheimer's Disease" by Lowenthal, Hull and Pearson in the Perspective Section of August 9 2012 issue of the New England Journal of Medicine.

Graphic: My photograph of medicine bottle and modified with ArtRage and Picasa3.

Extra-Marital Sex: Spouse of the Demented Marital Partner

Without additional discussion by me, I would like to pose a question to my visitors. There is a husband or wife of a severely demented (institutionalized Alzheimer's) patient who asks the doctor whether it would be the ethically right thing to do to engage now in extra-marital sex. What should be the doctor's response? Or what should the doctor find out before responding? ..Maurice.

Would you dare to refuse to have the batteries replaced?

Here is a question that I posed on Medpedia, medical information and discussion site. I thought I would also challenge the visitors here. ..Maurice.

You are the son or daughter and legal surrogate of a very elderly mother, care for her at home, who has

severe Alzheimer's Disease and has a cardiac pacemaker whose batteries are now failing. Would you

dare to refuse to have the batteries replaced?

Would your decision be any different if she was being cared for in a nursing home institution? Would refusal to replace failing batteries be any different than making a request to the patient's doctor to have the pacemaker with functioning batteries to be turned off? In answering these questions let's assume your mother never had anticipated having the need for a cardiac pacemaker so had never discussed with you about replacing batteries or for what reasons to request that it be turned off.

Publicizing the Illnesses of Celebrities: Is it Ethical?

Barron H. Lerner, MD, PhD,who is Associate Professor of Medicine and Public Health at Columbia University Medical Center and is the author of “When Illness Goes Public: Celebrity Patients and How We Look at Medicine,” just published by Johns Hopkins University Press sent me today the following commentary. He raises some interesting ethical concerns regarding the consequences of such publicity. Read his thoughts on this subject below and you may also wish to read his book. Let me know what you think about the ethics of this not uncommon social experience. ..Maurice.


Celebrity illnesses have alerted the public to a series of diseases—think of Lou Gehrig’s amytrophic lateral sclerosis, Betty Ford’s breast cancer, Arthur Ashe’s AIDS and Michael J. Fox’s Parkinson’s disease. But these cases have also raised a series of challenging ethical issues.

For example, celebrities have often “pushed the envelope” as far as experimental treatments go. Few realize that Gehrig participated in a clinical trial of Vitamin E injections for his disease beginning in 1939. The civil rights lawyer Morris Abram received two types of experimental immunotherapy for treatment of his acute myelogenous leukemia beginning in 1973. And actor Christopher Reeve advocated aggressively for embryonic stem cell research, which he believed would lead to remarkable breakthroughs in the treatment of his quadriplegia.

However, undergoing, publicizing and advocating for such therapies can create ethical problems. Members of the public with the same diseases, feeling desperate and assuming that celebrities necessarily get the best care, may assume that they should also enroll in experiments. As one woman with Parkinson’s said of Michael J. Fox, ““I just tried to follow right behind him and step in the footprints.” In addition, because society lionizes its celebrities, their illnesses are almost always remembered in a positive light. Thus, readers of The New York Times were told, incorrectly in retrospect, that Gehrig’s and Abram’s experimental therapies had been highly effective. In Reeve’s case, the potential value of stem cell research remains highly remains controversial.

Another ethical issue raised by celebrities concerns the allocation of research funding. These days, it seems that having a big name celebrity spokesperson is the best way to ensure funding support for a given disease. Such individuals are able to attract the attention of both the media and members of Congress. For example, Yasmin Aga Khan, the daughter of actress Rita Hayworth, who died of Alzheimer’s, has made several successful fundraising appearances for the disease on Capitol Hill. Fox has done the same for Parkinson’s and Lance Armstrong has been a tireless advocate for new cancer breakthroughs. While it is logical to think that scarce research dollars should instead be allocated based on need and chance of success, the current situation is unlikely to change.

And famous patients may not be purely altruistic in their advocacy efforts. In 2002 a scandal emerged when it was learned that a series of celebrities—including Kathleen Turner, Olympia Dukakis and Rob Lowe—had booked themselves onto talk shows to tout the supposed virtues of various pharmaceutical products. The fact that they were being paid to do so was unsaid until the media outed this practice.

In sum, celebrities can perform a great service in publicizing diseases and informing others about possible advances. But by dint of their great popularity, celebrity patients can also wield too much power, potentially misleading sick people at a most vulnerable time.

More On Human Dignity (1)

I have discussed something about human dignity and “death with dignity” in October 2005 postings. A Working Paperwas written by Adam Schulman, Ph.D. for the December 2005 meeting of the President’s Council on Bioethics. While it was prepared by staff solely to aid discussion and does not represent the official views of the Council or of the United States Government,nevertheless, the portion I have reproduced here helps to point to the conflicts people have in explaining what behaviors or acts support or deface human dignity. This can be the start of further discussion.


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“Human dignity”: is it a useful concept in bioethics, one that sheds important light on the whole range of bioethical issues, from embryo research and assisted reproduction, to biomedical enhancement, to care of the disabled and the dying? Or is it, on the contrary, a useless concept—at best a vague substitute for other, more precise notions, at worst a mere slogan that camouflages unconvincing arguments and unarticulated biases?
Although the Council has itself made frequent use of this notion in its writings, it has not undertaken a thematic exploration of human dignity, its meanings, its foundations, and its relevance for bioethics. In the meantime, at least one critic, noting that “appeals to human dignity populate the landscape of medical ethics,” has recently called into question whether human dignity has any place in bioethical discourse at all.1 It would seem timely, then, for the Council to take up the question of human dignity squarely, with the aim of clarifying whether and how it might be a useful concept in bioethics.
The purpose of this working paper is to help the Council focus its discussion of human dignity and its proper place in bioethics. To that end, it will first give some examples of how human dignity can be a difficult concept to apply in bioethical controversies. It will then explore some of the complex roots of the modern notion of human dignity, in order to shed light on why its application to bioethics is so problematic. Finally, it will suggest, tentatively, that a certain conception of human dignity—dignity understood as humanity—has an important role to play in bioethics, both now and especially in the future.

1. The problem of human dignity in bioethics: some examples

That human dignity might be at least problematic as a bioethical concept is suggested by the many ways it gets invoked in bioethical debates, often on different sides of the same issue. Consider, for example, a question raised in the Council’s recent exploration of ethical caregiving at the end of life:2 Is it morally acceptable for an elderly patient, diagnosed with early Alzheimer’s disease and facing an inexorable decline into dementia and dependency, to stop taking his heart medicine, in the hope of a quicker exit, one less distressing to himself and his family? One possible answer discussed in our report is that it is morally permissible (and perhaps even admirable) for such a patient, who finds the prospect of years of dementia humiliating or repellent and who is reluctant to become a burden to his family, to forgo medication and allow heart disease to carry him off in a more dignified and humane way. Another possible answer is that it is morally impermissible, because deliberately hastening the end of one’s life, even by an act of omission, is incompatible with the equal dignity and respect owed to all human life. A third answer is that respect for the dignity and autonomy of all persons requires us to defer to the personal choice of a competent individual in such intimate matters, regardless of how he or she might decide. Note that all three answers (and perhaps others that could be given) are grounded in part in some appeal to human dignity, though they reach quite different conclusions.

Or, to take an example from the beginning of human life, consider a question that might arise in a neonatal intensive care unit: What medical interventions are appropriate to save the life of a critically ill premature infant who is likely to survive, if at all, only with severe mental defects? One possible answer is that, because human dignity rests on our higher mental capacities, it is wrong to bring a person into the world burdened with a devastating lifelong mental incapacity. Another answer might be that every reasonable measure should be taken, because the equal dignity of all human life forbids us to declare some lives “not worth living.” Yet a third answer might be that, out of respect for their dignity and autonomy, the parents must be left free to resolve this moral dilemma for themselves.

Or, again, consider an example of biomedical “enhancement” examined in the fifth chapter of Beyond Therapy:3 If science were to develop memory-blunting drugs that could free us from the emotional burdens of intrusive and painful memories, would it be ethically permissible to give such drugs freely to people who have suffered grievous disappointments or witnessed horrifying events? One answer might be that such an invention, with its promise of liberating miserable people from the emotional tyranny of past misfortunes, ought to be embraced as an unqualified enhancement to human freedom, autonomy, and dignity. But another answer might be that human integrity and dignity require of us that we confront our painful memories and learn to deal with them (if possible) and not just “flush” them away by taking a pill. A third answer would be that this decision is properly left to the individual, whose dignity and autonomy entail the right of voluntary, informed consent.

In each of these examples, a variety of strong convictions can be derived from powerful but conflicting intuitions about what human dignity demands of us. Little wonder, then, that some bioethicists are inclined to wash their hands of “dignity” entirely, in favor of clearer and less ambiguous ethical concepts.

[References for this section of the Working Paper:

1. Ruth Macklin, “Dignity is a useless concept,” BMJ 327: 1419-1420, 2003. Dieter Birnbacher, another skeptic on the usefulness of human dignity as a bioethical concept, observes that there is a “nearly worldwide consensus that reproductive cloning is incompatible with human dignity and should be prohibited by law.” See his “Human cloning and human dignity,” Reproductive BioMedicine Online 10(Suppl. 1): 50-55, 2005.

2. The President’s Council on Bioethics, Taking Care: Ethical Caregiving in Our Aging Society, Washington, D.C.: Government Printing Office, 2005, chapter 4, pp. 154 ff.

3. The President’s Council on Bioethics, Beyond Therapy: Biotechnology and the Pursuit of Happiness, Washington, D.C.: Government Printing Office, 2003, chapter 5, pp. 214 ff.]
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I plan to present this paper in piecemeal segments so that we can cone down on the information presented to us. Looking at the conflicting examples suggested in the paper, I wonder how my visitors might accept one view but reject the other. Would anyone want to comment on which view of the examples given above the visitor accepts and why? ..Maurice.

Ethics:Treating a Patient for the Benefit of Others (1)

A decision by a physician about any medical treatment of a patient should be based on a risk vs benefit assessment. The possible risks and chance of risk may be fully or just partially known. The benefit can be a known patho-physiologic benefit (directly affecting the underlying disease) or it may include a quality of life or life goals or values consideration that is usually poorly known by the physician but best determined by the patient. When the patient is unconscious and/or does not have the mental capacity to inform or decide, then the physician will look to a surrogate. But the physician must make some degree of assessment before the medical treatment is offered or carried out.

How does one look at a clinical scenario where there is no direct benefit of treatment to the patient? And what if, in addition, there are physical or emotional risks? Why would a patient be treated without benefit? Well, one answer would be that the treatment of the patient was primarily to benefit others. One example in which the act doesn’t involve a drug or medical procedure would be the isolation of a communicable disease patient so that others would not be exposed to the disease. Another might be the current consideration regarding isolation of known pedophiles beyond the period of punishment again for safety concern for others.

Beyond these custodial treatments, there are medical pharmacologic or medical procedural treatments which occur which again do not medically benefit the patient but primarily benefits others. Treating those who have committed sexual crimes by castration or hormone injections in an attempt to protect others might be an example. Another which has been carried out in the past was the castration or tubal ligation of a mentally defective female to prevent her from becoming pregnant. Some of the sedation or tranquilization of Alzheimer’s patients might be prescribed by physician primarily to try to make the patient easier to manage by the caregiver and perhaps ease the emotional burden suffered by the caregiver. In this example one might argue that this patient therapy may be beneficial to the patient by hoping to prevent injury but also it might not.

A good example of the kind of treatment which occurs in medical practice which one can wonder about the ethics and the medical propriety is that of administering increasing doses of a narcotic such as IV morphine to a patient who is nearing the end of life from a serious illness such as strokes or cancer and who is already unconscious and clinically not in pain or in discomfort in order to satisfy the concerns of the bedside family. In terminally ill patients, occasional respiratory or muscular behavior can occur which will frighten the observing family members but clinically does not represent a comfort issue for the unconscious patient. If further morphine is administered, for example, the respiratory rate may be slowed to the point where respiration stops and the patient will die as a consequence of the administration. If the patient had been conscious or stuperous and was in frank discomfort, then the benefit of treating such a terminal patient with morphine would be medically and ethically appropriate despite the risk of death from the drug. Ethical support for this conclusion would come on the basis of the “double effect” principle.

The principle balances the good effect of the act (benefit) against the bad effect (risk). For an act to be ethical it must meet all 5 parts of the principle: 1) The act must be good or morally neutral, 2) Only the good effect is intended, 3) The good effect is not achieved through the bad effect, 4) There is no alternative way to achieve the good effect and 5) There is a proportionally good reason for running the risk. The question becomes is it ethical for an unconscious patient who clinically appears comfortable and in no distress be treated with a narcotic to further depress the patient’s nervous system to try to prevent a behavior which is unsettling only for the unsophisticated family watching and to provide them comfort while at the same time possibly risking and causing the premature death of the patient? More on this issue in a later posting. ..Maurice.

Commercialization of Eggs and Sperm for Reproduction: Is It Ethical?

Here is a thread and comments from my now inactive "Bioethics Discussion Pages" originally posted in 2000. The most recent posting by a visitor today is at the top of the page and the oldest is at the bottom. I would be interested reading from my visitors to this bioethics blog the pros and cons of selling eggs and sperm. ..Maurice.



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A highschool student wrote me about an issue which is worthy of discussion in these days when methods to overcome infertility problems are becoming more popular and sophisticated. In addition, some families are looking for ways to produce smarter and more attractive children. As there has been ethical discussion about selling organs for transplant, there has been interest to consider the ethics of selling gametes.

An interesting point brought up by the student was what happens if the purchasers of the gamete finds that the final product does not meet expectations. Who is to be held responsible and what will be the attitude of the parents about the child?


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Date: Tue, Mar 7, 2000 9:59 PM From: ricababes@hotmail.com To: DoktorMo@aol.com

Dear Dr. Mo,

I am a high school student who was recently assigned to complete a project on a bioethics topic. What first caught my attention was the commercialization of eggs and/or sperm for reproduction, so I researched the topic and would like to share the insight that I gained.

I was really bothered by the fact that selling and "donating" eggs and sperm is actually becoming a business. People are paying up to $150,000 to buy eggs or sperm from supermodels. One sperm bank offers sperm donations from only scientists with an I.Q. of over 135. Healthy, young, Ivy-league donors are being offered up to $50,000 for their "donations." Need some quick cash? I'll bet if your good-looking and score above a 28 on your ACT test, you could get at least $1,000 for your sperm!

What is evolving from this new trend is a market in which people are competing to get the best genes and those on the other end are trying to make the most money. So, what's wrong with that? We are talking about kids here- remember?!

If we allow this to continue, I fear children will become commodities. Many times I have spent large sums of money on something-let's say a new stereo- only to be disappointed. "I spent 200 bucks on that!" Is this how parents are going to react when their child, born of genes from a rocket scientist, comes home with a below average report card or is not as smart as they hoped he/she would be? Children are a miracle of nature and I believe that parents should love their children for who they are, unconditionally. Each person is precious and we should put an end to trying to place a monetary value on genes, children, and life. As the Mastercard slogan goes, "A newborn child who you can love and call your own: PRICELESS."

Here is the question:

Is it ethical to commercialize and sell eggs and sperm for reproduction?



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Date: Thu, Aug 10, 2006 7:12 PM From:livinsobo@earthlink.net To: DoktorMo@aol.com

In response to your question is it ethical to sell your eggs or sperm? That is what America is about, freedoms. We in America can wear what we want, say what we want, and pretty much do what we want as long as we don't hurt anyone in the process. What better place to be, in some countries women do not have rights, people wake up to gunshots and bombs. We live in a wonderful country and are protected by a military that upholds our freedom of choices.

While I think it is crazy to spend $150,000 on supermodel genes in hope that your child turns out beautiful, I personally don't think it is unethical. Think about this, who is the idiot paying for the supermodel eggs, and there is no guarantee your child will be beautiful. As far as the rocket scientist sperm and the child being a brainiac, I am a firm believer that smarts have alot to do with the way one is raised, that old question nature vs. nurture pops into my mind. Many people are quick to pass the buck on why there child is bad or slow but when a child is wonderful they accept the responsibility, well parents need to take a good hard look at themselves and assume responsibility for the good and the bad.

I too, have contemplated selling my eggs, and here is the reason why, I do not plan to have any children at this time and nor do I feel that I would be able to offer a child the kind of home that he or she would need, however there are people out in this world that deserve to have children and can't. Also think about this, donating and receiving eggs can be an evasive process, the parent that goes through taking hormones, drugs, and possibility that it may not take the first go around, deserve it and would probably love that child more than anything.

So next time you are sitting in biology class in front of that state of the art microscope or that great computer that you have at your disposal, think about how that technology has helped you, and while that is on a different level than the topic at hand, that same technology that has helped you in school has helped people have babies, cure certain diseases, and hopefully cure something like AIDS or CANCER. Its all about progress. We can not live in the dark ages.

Sincerely
Future EGG DONOR
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Date: Thu, Jun 26, 2003 9:16 PM From: mistycrims@alltel.net To: DoktorMo@aol.com
I do not feel like this is a good idea because human life should not be used forpersonal gain. But are eggs and sperm seperately human life? I find it interesting that society generally sees prostitution as unethical but may argue "my eggs, my body, my right to sale". I believe this business could lead to more controversial issues. Like, can a woman sale her unborn child? Misty Crims


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Date: Fri, May 16, 2003 4:55 PM From: philosopher@paradox3000.com To: DoktorMo@aol.com
The ethical and moral nature of selling ones reproductive capability are completely arbitrary and specific to both the context and the culture at the time of the trade.

Any pretty woman can go out and seduce an intelligent man to "collect" his sperm, and I would bet a rich man could convince even a beautiful woman to mate and reproduce with him (it's not uncommon). How is this different than selling your cells? It isn't. Is the offspring of such a union less valuable than a union of "true love", of course not.

What is important at this time is that we are so ignorant as to the biological nature of properties like intelligence, beauty, or personality that to try to manipulate them is all but futile.

Why then shouldn't we give people better control over their reproductive power? Why not try and make people smarter, stronger, better? Religious fascists might object based upon their arbitrary beliefs, but we know that when they are faced with the fact that their offspring may be retarded while others will have genius level I.Q.s, their minds will change.

There are objective scientific reasons to regulate some of these new technologies. For instance you wouldn't want a man selling his sperm to millions of women. This would reduce genetic diversity and thus long term survivability. You wouldn't want people to misrepresent themselves and thus their genetic abilities, so smart buyers will use independent third parties to test the value of the genetic donors. Overpopulation is a world wide problem, perhaps we should start testing and licensing parents, too?


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Date: Tue, Mar 18, 2003 8:41 AM From: CurtsT@leb.k12.in.us To: DoktorMo@aol.com
Yes. I believe that it is ethical to sell your sperm or eggs for a profit. They are part of your body and you own them. Also you could be giving them to people who could not use their own eggs or sperm to have a child and want to provide a loving home. Maybe some of the motives behind this are wrong but that dosen't make this immoral or unethical. I do believe that for now it is not acceptable to society but as history has shown society is not that difficult to persude with time.


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Date: Thu, Feb 28, 2002 8:00 AM From: dpmartin@owc.net To: DoktorMo@aol.com
We should do two things. First, we should take care of the children we have. Second, we should minimize the genetic defects in the children we give birth to in the future. If commercialization of eggs and sperm is accomplished in a manner consistent with meeting these goals, then it is acceptable. The recent article in JAMA about the woman who chose to avoid having a child with early onset Alzheimer's disease is, in my opinion, a proper use of genetics in reproduction.


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Date: Sat, Feb 9, 2002 11:47 PM From: lettaylor@pisp.net To: DoktorMo@aol.com
As a Christian I feel that this is wrong. The Designer did not have this in mind when He made humans in His image. While humanity is learning much about life, we will fail the test if we do not learn that it is precious and NOT FOR SALE! I know that the original design was made by One far greater than ourselves and we cannot replicate that design without severe ramifications. Consider the atom!


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Date: Thu, Jan 17, 2002 7:14 AM From: bearmccloud@attbi.com To: DoktorMo@aol.com
NO!!!

It is not ethical to sell sperm. It is natures way of keeping mankind from being overpopulated to make some people infertile. If we were all fertile and all capable of creating children anytime we wanted to then the entire world would be like china is today. Overcrouded and under reasourced.


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Date: Sun, Jul 1, 2001 1:44 PM From: aim_2000@swbell.net To: DoktorMo@aol.com
This was interesting to me. I don't believe that everyone who is purchasing the sperm and eggs are doing so just to have smarter or more beautiful children. Some are doing so because it may be there only alternative. It is difficult to draw the line between allowing those people the ability to purchase gametes, and not the others who are doing it for personal gain. And by the way, just because someone is genetically inclined to be more intelligent does not mean that he or she will be. it takes lots of love and attention on the part of the parents to foster and encourage children in the love of learning.


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Date: Mon, Jan 29, 2001 3:25 AM From: cailab@tin.it To: DoktorMo@aol.com
Hello, we're two students of a high school and we'd like to say our opinion about eggs/sperma donation or sale.We think that selling eggs or sperm is immoral,because it's not a natural way to have children. We mean, there are so many orphans who need to be taken care of that it's useless "build" children in a scientific way. Nowadays man is trying to take control of the world, but we think this is a sort of "upsidedown" of natural order.


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Date: Tue, Jan 9, 2001 3:27 AM From: cailab@tin.it To: DoktorMo@aol.com
We are two students,we are interested about this discussion and we have decided to give our opinion. We desagree with the commercialisation of eggs and sperm.We believe that parents should appreciate their children for who they are without thinking only of their good qualities.They have also toappreciate their defauts because they are "BLOOD ON BLOOD" as a song of Jon Bon Jovi says.


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Date: Tue, Mar 28, 2000 7:38 PM From: sstellje@mesastate.edu To: DoktorMo@aol.com
Dear Dr. Mo: I am a nursing student and I was browsing your site for an assignment for one of my classes. When I read the topic "Is it ethical to commercialize and sell eggs and sperm for reproduction?" I was intrigued. The reason I was intrigued is because I also work in childcare, and every day I see parents and children and the way that they interact. There are so many unwanted, "oops" children in this world that it is heart breaking. I recently had an experience with a young mother who was planning on giving her third child up for adoption. Her two other children both had some sort of disabilities and were adopted out, and she did not want to "deal with" another one. However, when she had her child it ended up being a perfect little girl with no disabilities, so she decided to keep her. When I first read the comment of the high school student who wrote to you I did not think at first that someone would want a "refund" on a child. But, then I remembered this young mother who had no trouble adopting out her other two children because of disabilities and keeping the perfect child. Why wouldn't it be possible? In our world today it is sad to say that I do believe people would try to get a "refund" or even sue somebody because their child did not come out the way they were supposed to. What about the children who are created from the super models, if they are not pretty enough or glamorous when they grow up will the parents be upset? What if the child from the sperm of the scientist ends up having mental disabilities or an IQ below average, will those parents be upset and demand compensation? At first you would think no. However you would then think, did these parents really purchase the sperm and eggs to have a child or a trophy? I would hope it was to have a child, but more often than we would like it is to have a trophy. There are so many unwanted children that need to be adopted to families, that it seems really selfish for these people to spend thousands of dollars on eggs or sperm instead of on adopting and raising a child who really needs a home. I personally have a slim chance of having children, does that mean I should go out and seek the perfect egg so I can have a child? No, for me it means that I should look at the children in this world, this country that need homes and provide that for them. I should spend those thousands of dollars that would have been spent on those eggs and put it towards a child who needs a home, education, clothes, and most of all love.

A Chronology of Human Research: The Sad and the Hope

Humans have been used as subjects for research of one kind and another for ages. The research may have been for practical or theoretical reasons but basically to learn something about human biology or humanity. Unfortunately, there has been some research on human subjects simply to boost the researcher’s ego or standing or for purely political or ideological reasons. Because of the Nazi experience and subsequent court trials, the Judgment of Nuremberg Code was written and since then there have been other codes and laws to attempt to make research using human subjects as rational, safe and ethical as possible. In more recent years withn the U.S., institutional research boards (IRB) have been set up to screen research on humans at the local level as well as an office for the protection of human subjects at a federal level. But there still are mistakes in research or worse and it takes organizations such as the Alliance for Human Research Protection (a national network promoting the protection of human subjects in medical research) and others to keep watch. Despite legal protection and institutional "review", there still are areas of human research which needs more attention including informed consent, conflict of interest, studies of children or mentally incompetent, study results not being published and issues of patent rights amongst many others.

To give my visitor a long view of the history of the human research; the bad and ethically sad research but also those activities which were designed to hope for human protection and good ethics, I have posted below a “Chronology of Human Research” with the permission of the author and Alliance for Human Research Protection on whose site the chronology was published.


Human Experiments: A Chronology of Human Research
by Vera Hassner Sharav


6th century B.C.: Meat and vegetable experiment on young Jewish prisoners in Book of Daniel.
5th century B.C: "Primum non nocere" ("First do no harm"), medical ethics standard attributed to Hippocrates. This Oath became obligatory for physicians prior to practicing medicine in the 4th century AD
1st century B.C. Cleopatra devised an experiment to test the accuracy of the theory that it takes 40 days to fashion a male fetus fully and 80 days to fashion a female fetus. When her handmaids were sentenced to death under government order, Cleopatra had them impregnated and subjected them to subsequent operations to open their wombs at specific times of gestation. [http://www.jlaw.com/Articles/NaziMedExNotes.html#1]
12th century: Rabbi and physician Maimonides' Prayer: "May I never see in the patient anything but a fellow creature in pain."
1796 Edward Jenner injects healthy eight-year-old James Phillips first with cowpox then three months later with smallpox and is hailed as discoverer of smallpox vaccine.

1845-1849: J. Marion Sims, "the father of gynecology" performed multiple experimental surgeries on enslaved African women without the benefit of anesthesia. After suffering unimaginable pain, many lost their lives to infection. One woman was made to endure 34 experimental operations for a prolapsed uterus. http://www.coax.net/people/lwf/jm_sims.htm
1865: French physiologist Claude Bernard publishes "Introduction to the Study of Human Experimentation," advising: "Never perform an experiment which might be harmful to the patient even though highly advantageous to science or the health of others."
1896: Dr. Arthur Wentworth performed spinal taps on 29 children at Children's Hospital, Boston, to determine if the procedure was harmful. Dr. John Roberts of Philadelphia, noting the non-therapeutic indication, labeled Wentworth's procedures "human vivisection."
1897: Italian bacteriologist Sanarelli injects five subjects with bacillus searching for a causative agent for yellow fever.
1900: Walter Reed injects 22 Spanish immigrant workers in Cuba with the agent for yellow fever paying them $100 if they survive and $200 if they contract the disease.
1900: Berlin Code of Ethics. Royal Prussian Minister of Religion, Education, and Medical Affairs guaranteed that: "all medical interventions for other than diagnostic, healing, and immunization purposes, regardless of other legal or moral authorization are excluded under all circumstances if (1) the human subject is a minor or not competent due to other reasons; (2) the human subject has not given his unambiguous consent; (3) the consent is not preceded by a proper explanation of the possible negative consequences of the intervention." http://www.geocities.com/artnscience/00berlincode.pdf
1906: Dr. Richard Strong, a professor of tropical medicine at Harvard, experiments with cholera on prisoners in the Philippines killing thirteen.
1913: Pennsylvania House of Representatives recorded that 146 children had been inoculated with syphilis, "through the courtesy of the various hospitals" and that 15 children in St. Vincent's House in Philadelphia had had their eyes tested with tuberculin. Several of these children became permanently blind. The experimenters were not punished.

1915: A doctor in Mississippi, working for the U.S. Public Health Office produces Pellagra in twelve Mississippi inmates in an attempt to discover a cure for the disease
1919-1922: Testicular transplant experiments on five hundred prisoners at San Quentin.
1927: Carrie Buck of Charlottesville is legally sterilized against her will at the Virginia Colony Home for the Mentally Infirm. Carrie Buck was the mentally normal daughter of a mentally retarded mother, but under the Virginia law, she was declared potentially capable of having a "less than normal child." By the 1930s, seventeen states in the U.S. have laws permitting forced sterilization
The settlement of Poe v. Lynchburg Training School and Hospital (same institution, different name) in 1981 brought to an end the Virginia law. It is estimated that as many as 10,000 perfectly normal women were forcibly sterilized for "legal" reasons including alcoholism, prostitution, and criminal behavior in general.
1931: Lubeck, Germany, 75 children die in from pediatrician's experiment with tuberculosis vaccine.
1931: Germany adopts "Regulation on New Therapy and Experimentation" requiring all human experiments to be preceded by animal experiments. This law remained in effect during the Nazi regime.

1931: Dr. Cornelius Rhoads, a pathologist, conducted a cancer experiment in Puerto Rico under the auspices of the Rockefeller Institute for Medical Investigations. Dr. Rhoads has been accused of purposely infecting his Puerto Rican subjects with cancer cells. Thirteen of the subjects died. A Puerto Rican physician uncovered the experiment an investigation covered-up the facts. Despite Rhoads' hand written statements that the Puerto Rican population should be eradicated, Rhoads went on to establish U.S. Army Biological Warfare facilities in Maryland, Utah, and Panama, and was later named to the U.S. Atomic Energy Commission. Rhoads was also responsible for the radiation experiments on prisoners, hospital patients, and soldiers. The American Association for Cancer Research honored him by naming its exemplary scientist award the Cornelius Rhoads Award.
1932-1972: U.S. Public Health Service study in Tuskegee, Alabama of more than 400 black sharecroppers observed for the natural course of untreated syphilis.
1932: Japanese troops invade Manchuria. Dr. Shiro Ishii, a prominent physician and army officer begins preliminary germ warfare experiments.
1936: Japan's Wartime Human Biowarfare Experimentation Program.
1938: Japan establishes Unit 731 in Pingfan, 25 km. from Harbin. Unit 731, a biological-warfare unit disguised as a water-purification unit, is formed outside the city of Harbin.
1939: Third Reich orders births of all twins be registered with Public Health Offices for purpose of genetic research.
1939: Twenty-two children living at the Iowa Soldiers' Orphans' Home in Davenport were the subjects of the "monster" experiment that used psychological pressure to induce children who spoke normally to stutter. It was designed by one of the nation's most prominent speech pathologists, Dr. Wendell Johnson, to test his theory on the cause of stuttering.
1940: Poisonous gas experiments at Unit 731. One experiment conducted September 7-10, 1940, on 16 Chinese prisoners who were exposed to mustard gas in a simulated battle situation.
1940-1941: Unit 731 used aircraft to spread cotton and rice husks contaminated with the black plague at Changde and Ningbo, in central China. About 100 people died from the black plague in Ningbo as a result.

1940's: In a crash program to develop new drugs to fight Malaria during World War II, doctors in the Chicago area infected nearly 400 prisoners with the disease. Although the Chicago inmates were given general information that they were helping with the war effort, they were not informed about the nature of the experiment. Nazi doctors on trial at Nuremberg cited the Chicago studies as precedents to defend their own research aimed at aiding the German war effort.
1941: Sterilization experiments at Auschwitz.
1941-1945: Typhus experiments at Buchenwald and Natzweiler concentration camps.
1941: Dr. William c. Black inoculated a twelve month old baby with herpes. He was criticized by Francis Payton Rous, editor of the Journal of Experimental Medicine, who called it "an abuse of power, an infringement of the rights of an individual, and not excusable because the illness which followed had implications for science." Dr. Rous rejected outright the fact that the child had been "offered as a volunteer."
1942 –1945: Unit 731. Ishii begins "field tests" of germ warfare and vivisection experiments on thousands of Chinese soldiers and civilians. Chinese people who rebelled against the Japanese occupation were arrested and sent to Pingfan where they became human guinea pigs; there is evidence that some Russian prisoners were also victims of medical atrocities. "I cut him open from the chest to the stomach and he screamed terribly and his face was all twisted in agony. He made this unimaginable sound, he was screaming so horribly. But then finally he stopped. This was all in a day's work for the surgeons, but it really left an impression on me because it was my first time." NYT
These prisoners were called 'maruta' (literally 'logs') by the Japanese. After succumbing to induced diseases - including bubonic plague, cholera, anthrax - the prisoners were usually dissected while still alive, their bodies then cremated within the compound. Tens of thousands died. The atrocities were committed by some of Japan's most distinguished doctors recruited by Dr. Ishii.

1942: High altitude or low pressure experiments at Dachau concentration camp.
1942: Harvard biochemist Edward Cohn injects sixty-four Massachusetts prisoners with beef blood in U.S. Navy-sponsored experiment.
1942: Japanese sprayed cholera, typhoid, plague, and dysentery pathogens in the Jinhua area of Zhejian province (China). A large number of Japanese soldiers also fell victim to the sprayed diseases.
1942-1943: Bone regeneration and transplantation experiments on female prisoners at Ravensbrueck concentration camp.
1942-1943: Freezing experiments at Dachau concentration camp.
1943 Refrigeration experiment conducted on sixteen mentally disabled patients who were placed in refrigerated cabinets at 30 degree Farenheit, for 120 hours, at University of Cincinnati Hospital., "to study the effect of frigid temperature on mental disorders."

1942-1943: Coagulation experiments on Catholic priests at Dachau concentration camp.
1942-1944: U.S. Chemical Warfare Service conducts mustard gas experiments on thousands of servicemen.
1942-1945: Malaria experiments at Dachau concentration camp on more than twelve hundred prisoners.
1943: Epidemic jaundice experiments at Natzweiler concentration camp.
1943-1944: Phosphorus burn experiments at Buchenwald concentration camp.
1944: Manhattan Project injection of 4.7 micrograms of plutonium into soldiers at Oak Ridge.
1944: Seawater experiment on sixty Gypsies who were given only saltwater to drink at Dachau concentration camp.
1944-1946: University of Chicago Medical School professor Dr. Alf Alving conducts malaria experiments on more than 400 Illinois prisoners.
1945: Manhattan Project injection of plutonium into three patients at Billings Hospital at University of Chicago.
1945: Malaria experiment on 800 prisoners in Atlanta.
1946: Opening of Nuremberg Doctors Trial by U.S. Military Tribunal.
1945: Japanese troops blow up the headquarters of Unit 731 in final days of Pacific war. Ishii orders 150 remaining ''logs'' (i.e., human beings) killed to cover up their experimentation. Gen. Douglas MacArthur is named commander of the Allied powers in Japan.

1946: U.S. secret deal with Ishii and Unit 731 leaders cover up of germ warfare data based on human experimentation in exchange for immunity from war-crimes prosecution.
1946-1953: Atomic Energy Commission sponsored study conducted at the Fernald school in Massachusetts. Residents were fed Quaker Oats breakfast cereal containing radioactive tracers.
1946: Patients in VA hospitals are used as guinea pigs for medical experiments. In order to allay suspicions, the order is given to change the word "experiments" to "investigations" or "observations" whenever reporting a medical study performed in one of the nation's veteran's hospitals.
1947: Colonel E.E. Kirkpatrick of the U.S. Atomic Energy Comission issues a secret document (Document 07075001, January 8, 1947) stating that the agency will begin administering intravenous doses of radioactive substances to human subjects.
1947: The CIA begins its study of LSD as a potential weapon for use by American intelligence. Human subjects (both civilian and military) are used with and without their knowledge.
1947: Judgment at Nuremberg Doctors Trial sets forth "Permissible Medical Experiments" – i.e., the Nuremberg Code, which begins: "The voluntary consent of the human subject is absolutely essential."
1949: Intentional release of radiodine 131 and xenon 133 over Hanford Washington in Atomic Energy Commission field study called "Green Run."
1949: Soviet Union's war crimes trial of Dr. Ishii's associates.
1949-1953: Atomic Energy Commission studies of mentally disabled school children fed radioactive isotopes at Fernald and Wrentham schools.

1940s-1950s: "psychic driving" and "mental departterning" experiments conducted by Dr. Ewen Cameron, depriving patients of sleep, using massive ECT combined with psychoactive drugs such as, LSD. After his "treatments" patients were unable to function. In the 1950's Dr.Cameron's experiments were sponsored by the CIA.
1950: Dr. Joseph Stokes of the University of Pennsylvania infects 200 women prisoners with viral hepatitis.
1950: U.S. Army secretly used a Navy ship outside the Golden Gate to spray supposedly harmless bacteria over San Francisco and its outskirts. Eleven people were sickened by the germs, and one of them died.
1951-1960: University of Pennsylvania under contract with U.S. Army conducts psychopharmacological experiments on hundreds of Pennsylvania prisoners.
1952-1974: University of Pennsylvania dermatologist Dr. Albert Kligman conducts skin product experiments by the hundreds at Holmesburg Prison; "All I saw before me," he has said about his first visit to the prison, "were acres of skin."
1952: Henry Blauer injected with a fatal dose of mescaline at New York State Psychiatric Institute of Columbia University. U.S. Department of Defense, the sponsor, conspired to conceal evidence for 23 years. I
1953 Newborn Daniel Burton rendered blind at Brooklyn Doctor's Hospital due to high oxygen study on RLF.

1953-1957: Oak Ridge-sponsored injection of uranium into eleven patients at Massachusetts General Hospital in Boston.
1953-1960: CIA brainwashing experiments with LSD at eighty institutions on hundreds of subjects in a project code named "MK-ULTRA."
1953-1970: U.S. Army experiments with LSD on soldiers at Fort Detrick, Md.
1954-1974: U.S. Army study of 2,300 Seventh-Day Adventist soldiers in 157 experiments code named "Operation Whitecoat."
1950s –1972: Mentally disabled children at Willowbrook School (NY) were deliberately infected with hepatitis in an attempt to find a vaccine. Participation in the study was a condition for admission to institution.
1956: Dr. Albert Sabin tests experimental polio vaccine on 133 prisoners in Ohio.
1958-1962: Spread of radioactive materials over Inupiat land in Point Hope, Alaska in Atomic Energy Commission field study code named "Project Chariot."
1962: Thalidomide withdrawn from the market after thousands of birth deformities blamed in part on misleading results of animal studies; the FDA thereafter requires three phases of human clinical trials before a drug can be approved for the market.
1962 to 1966, a total of 33 pharmaceutical companies tested 153 experimental drugs at Holmesburg prison (PA) alone.
1962-1980 Pharmaceutical companies conduct phase I safety testing of drugs almost exclusively on prisoners for small cash payments.
1962: Injection of live cancer cells into 22 elderly patients at Jewish Chronic Disease Hospital in Brooklyn. Administration covered up, NYS licensing board placed the principal investigator on probation for one year. Two years later, American Cancer Society elected him Vice President.
1962: Stanley Milgram conducts obedience research at Yale University.
1963: NIH supported researcher transplants chimpanzee kidney into human in failed experiment.

1963-1973: Dr. Carl Heller, a leading endocrinologist, conducts testicular irradiation experiments on prisoners in Oregon and Washington giving them $5 a month and $100 when they receive a vasectomy at the end of the trial.
1964: World Medical Association adopts Helsinki Declaration, asserting "The interests of science and society should never take precedence over the well being of the subject."
1965-1966: University of Pennsylvania under contract with Dow Chemical conducts dioxin experiments on prisoners at Holmesburg.
1966: Henry Beecher's article "Ethics and Clinical Research" in New England Journal of Medicine.
1966: U.S. Army introduces bacillus globigii into New York subway tunnels in field study.
1966: NIH Office for Protection of Research Subjects ("OPRR") created and issues Policies for the Protection of Human Subjects calling for establishment of independent review bodies later known as Institutional Review Boards.
1967: British physician M.H. Pappworth publishes "Human Guinea Pigs," advising "No doctor has the right to choose martyrs for science or for the general good."
1969: Judge Sam Steinfield's eloquent dissent in Strunk v. Strunk, 445 S.W.2d 145, the first judicial suggestion that the Nuremberg Code should influence American jurisprudence.
1969. Milledgeville Georgia, investigational drugs tested on mentally disabled children. No institutional approval.
1969: San Antonio Contraceptive Study conducted on 70 poor Mexican-American women. Half received oral contraceptives the other placebo. No informed consent.
1973 Ad Hoc Advisory Panel issues Final Report of Tuskegee Syphilis Study, concluding "Society can no longer afford to leave the balancing of individual rights against scientific progress to the scientific community."
1974: National Research Act establishes National Commission for the Protection of Human subjects and requires Public Health Service to promulgate regulations for the protection of human subjects.
1975: The Department of Health, Education and Welfare (DHEW) raised NIH's 1966 Policies for the Protection of Human subjects to regulatory status. Title 45 of the Code of Federal Regulations, known as "The Common Rule," requires the appointment and utilization of institutional review boards (IRBs).
1976: National Urban League holds National Conference on Human Experimentation, announcing "We don't want to kill science but we don't want science to kill, mangle and abuse us."
1978: Experimental Hepatitis B vaccine trials, conducted by the CDC, begin in New York, Los Angeles and San Francisco. Ads for research subjects specifically ask for promiscuous homosexual men.

1979: National Commission issues Belmont Report setting forth three basic ethical principles: respect for persons, beneficence, and justice.
1980: The FDA promulgates 21 CFR 50.44 prohibiting use of prisoners as subjects in clinical trials shifting phase I testing by pharmaceutical companies to non-prison population.
1981: Leonard Whitlock suffers permanent brain damage after deep diving experiment at Duke University.
1986: Congressional subcommittee holds one-day hearing in Washington, called by Rep. Pat Williams of Montana, aimed at determining whether U.S. prisoners of war in Manchuria were victims of germ-warfare experimentation. Hearing is inconclusive.
1981-1996: Protocol 126 at Fred Hutchinson Cancer Center in Seattle.
1987: Supreme Court decision in United States v. Stanley, 483 U.S. 669, holding soldier given LSD without his consent could not sue U.S. Army for damages.
1987:" L-dopa challenge and relapse" experiment conducted on 28 U.S. veterans who were subjected to psychotic relapse for study purposes at the Bronx VA.
1990: The FDA grants Department of Defense waiver of Nuremberg Code for use of unapproved drugs and vaccines in Desert Shield.
1991: World Health Organization announces CIOMS Guidelines which set forth four ethical principles: respect for persons, beneficence, nonmaleficence and justice.
1991: Tony LaMadrid commits suicide after participating in study on relapse of schizophrenics withdrawn from medication at UCLA.
1993: Kathryn Hamilton dies 44 days after participating in breast cancer experiment at Fred Hutchinson Cancer Center in Seattle.
1994. The Albuquerque Tribune publicizes 1940s experiments involving plutonium injection of human research subjects and secret radiation experiments. Indigent patients and mentally retarded children were deceived about the nature of their treatment.
1994. President Clinton appoints the Advisory Commission on Human Radiation Experiments (ACHRE) The ACHRE Report http://tis.eh.doe.gov/ohre/roadmap/achre/index.html

1995. U.S. Department of Energy (DOE) published Human Radiation Experiments, listing 150 plus an additional 275 radiation experiments conducted by DOE and the Atomic Energy Commission, during the 1940s-1970s. http://tis.eh.doe.gov/ohre/roadmap/experiments/0491doca.html#0491_List
1995: 19-year-old University of Rochester student Nicole Wan dies after being paid $150 to participate in MIT-sponsored experiment to test airborne pollutant chemicals.
1995. President Clinton appoints the National Bioethics Advisory Commission.
1995: NYS Supreme Court rules (TD v NYS Office of Mental Health) against the state's policy of conducting nontherapeutic experiments on mentally incapacitated persons - including children - without informed consent. Justice Edward Greenfield ruled that parents have no authority to volunteer their children:
"Parents may be free to make martyrs of themselves, but it does not follow that they may make martyrs of their children."

1995: Thirty-four healthy, previously non-aggressive New York City minority children, boys aged 6 to 11 years old, were exposed to fenfluramine in a nontherapeutic experiment at the New York State Psychiatric Institute. The children were exposed to this neurotoxic drug to record their neurochemical response in an effort to prove a speculative theory linking aggression to a biological marker.
1996. Cleveland Plain Dealer investigative report series, 'Drug Trials: Do People Know the Truth About Experiments,' December 15 to 18, 1996. The Plain-Dealer found: of the "4,154 FDA inspections of researchers testing new drugs on people [since 1977] . . . more than half the researchers were cited by FDA inspectors for failing to clearly disclose the experimental nature of their work."
1996: Yale University researchers publish findings of experiment that subjected 18 stable schizophrenia patients to psychotic relapse in an amphetamine provocation experiment at West Haven VA.
1997. President Clinton issues a formal apology to the subjects of the Tuskegee syphilis experiments. NBAC continues investigation into genetics, consent, privacy, and research on persons with mental disorders.
1997. Researchers at the University of Cincinnati publish findings of experiment attempting to create a "psychosis model" on human beings at the Cincinnati VA. Sixteen patients, experiencing a first episode schizophrenia, were subjected to repeated provocation with amphetamine. The stated purpose was to produce "behavioral sensitization. This process serves as a model for the development of psychosis, but has been little studied in humans. Symptoms, such as severity of psychosis and eye-blink rates, were measured hourly for 5 hours."
1997. U.S. government sponsored placebo-controlled experiment withholds treatment from HIV infected, pregnant African women. NY Times, Sept. 18.
1997. Victims of unethical research at major U.S. medical centers - including the NIMH - testify before the National Bioethics Advisory Commission, Sept. 18.

1997. FDA Modernization Act gives pharmaceutical companies a huge financial incentive - a 6 month patent exclusivity extension - if they conduct drug tests on children. The incentive can yield $900 million.
1998. National Bioethics Advisory Commission (NBAC) Report. Research Involving Subjects with Mental Disorders That May Affect Decisionmaking Capacity. November 12, 1998 http://bioethics.georgetown.edu/nbac/capacity/TOC.htm
1998: The Japanese government has never formally apologized for Unit 731's activities, and did not even admit to its existence until August 1998, when the Supreme Court ruled that the existence of the unit was accepted in academic circles.
1998. Complaint filed with OPRR about experiments that exposed non-violent children in New York City to fenfluramine to find a predisposition to violence.
1998: Boston Globe (four part) series, "Doing Harm: Research on the Mentally Ill" shed light on the mistreatment and exploitation of schizophrenia patients who have been subjected to relapse producing procedures in unethical experiments.
1999: Nine month-old Gage Stevens dies at Children's Hospital in Pittsburgh during participation in Propulsid clinical trial for infant acid reflux.
1999: 18-year-old Jesse Gelsinger dies after being injected with 37 trillion particles of adenovirus in gene therapy experiment at University of Pennsylvania.
1999: Director of National Institute of Mental Health suspends 29 clinical trials that failed to meet either ethical or scientific standards.
2000: University of Oklahoma melanoma trial halted for failure to follow government regulations and protocol.
2000: OPRR becomes Office of Human Research Protection ("OHRP") and made part of the Department of Health and Human Services.
2000: President Clinton implement the Energy Employees Occupational Illness Compensation Act of 2000, which authorized compensation for thousands of Department of Energy workers who sacrificed their health in building the nation's nuclear defenses.
2000: The Washington Post (6 part) series, "Body Hunters" exposes unethical exploitation in experiments conducted by U.S. investigators in underdeveloped countries. Part 4 dealt with U.S. government funded, genetic experiments conducted by Harvard University in rural China.
http://www.washingtonpost.com/wp-dyn/articles/A26797-2000Dec19.html
2001: A biotech company in Pennsylvania asks the FDA for permission to conduct placebo trials on infants in Latin America born with serious lung disease though such tests would be illegal in U.S.
2001: Ellen Roche, a healthy 27-year old volunteer, dies in challenge study at Johns Hopkins University in Baltimore, Maryland.
2001: April 4, Elaine Holden-Able, a healthy retired nurse, consumed a glass of orange juice that had been mixed with a dietary supplement for the sake of medical research. This Case Western University Alzheimer's experiment, financed by the tobacco industry, wound up killing her in what was called a ''tragic human error.'' Federal Office of Human Research Protections did not interview hospital staff, mostly accepted hospital's internal report, imposed no penalty, and closed the case and did not mention the death in its letter of determination. http://ohrp.osophs.dhhs.gov/detrm_letrs/nov01f.pdf
2001: Maryland Court of Appeals renders a landmark decision affirming "best interest of the individual child" as a standard for medical research involving children. The Court unequivocally prohibited nontherapeutic experimentation on children. (Higgins and Grimes v. Kennedy Krieger Institute).The case involved exposure of babies and small children to lead poisoning in EPA funded experiment. (http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf)

ADDENDUM: The author has e-mailed me that the chronology needs updating of more recent research projects. I hope she will be able to provide these updates later. ..Maurice.