Clinical Bioethics Blog

New York will pass the Family Health Care Decisions Act

Bernard Freedman — Wed, 24 Feb 2010 22:12:36 -0800

It has been 17 years since this bill was first introduced.

The New York State Senate will pass the Family Health Care Decisions Act (FHCDA), setting forth clear guidelines for family members and others close to the patient to make medical decisions for incapacitated patients. It will also provide physicians with uniform protocols to follow. In many instances there will continue to be confusion and concern for the rights of the patient. Diligent and thoughtful efforts will be needed to apply these guidelines properly. The following are some of the important points for clinicians:

If there is disagreement about whether the individual lacks decision-making capacity, the matter is referred to the hospital or nursing home ethics committee for resolution.

The FHCDA directs the surrogate to make decisions in accordance with the patient’s wishes, including the patient’s religious and moral beliefs.

A surrogate may withhold or withdraw life-sustaining treatment for an individual if that individual will die within six months with or without treatment, as determined by two independent physicians, and treatment would be an extraordinary burden to the patient.

A surrogate may also withhold or withdraw life-sustaining treatment if the patient has an irreversible condition, as determined by two independent physicians, and treatment would involve such pain, suffering, or other burden that it would be inhumane or extraordinarily burdensome to provide treatment under the circumstances.

For Individuals Without a Surrogate:

The attending physician to act as surrogate for routine medical treatment.

For major medical treatment, a physician may act only upon the concurrence of another physician that such major medical treatment is necessary.

A physician may withhold or withdraw life-sustaining treatment for individuals without a surrogate only upon the independent concurrence of another physician that life-sustaining treatment offers no medical benefit to the patient because the patient will die imminently and the provision of life-sustaining treatment would violate accepted medical standards.

Poem: Denise Levertov

Bernard Freedman — Sat, 13 Feb 2010 21:54:38 -0800

This is the year the old ones,
the old great ones
leave us alone on the road.
- Denise Levertov, September 1991

Use of Feeding Tubes in Patients with Advanced Dementia is Higher in For-Profit Facilities

Bernard Freedman — Wed, 10 Feb 2010 23:47:40 -0800

Dementia is now a leading cause of death in the United States

A study was published this week in JAMA (Journal of the American Medical Association) regarding nursing home patients with advanced dementia and who have feeding tubes inserted. The results showed that the frequency of feeding tubes is greater in for-profit hospitals versus government or state owned hospitals.

"A higher rate of feeding tube insertions also was independently associated with for-profit ownership vs hospitals owned by state or local government...

White residents had the lowest likelihood of feeding tube insertion, while black residents experienced nearly a 2-fold increase in the likelihood of feeding tube insertion...

Written advance directives, do not resuscitate orders,and orders to forgo artificial hydration and nutrition were independently associated with lower likelihood of feeding tube insertion."

Previous studies have found that the survival rate of patients with advanced dementia who have feeding tubes are not improved. It is estimated that one-third of nursing home residents with advanced cognitive impairment have feeding tubes inserted and the majority of these tubes are placed during acute care hospitalizations. Thereafter, many chronically ill patients continue to be maintained on tube feeding in ICUs in the last six months of life.

The use of advance health directives decrease the rate of patients on feeding tubes. Yet, as dementia advances it becomes increasingly difficult to obtain advance orders from patients who have lost the capacity to make decisions for themselves. It is estimated that the prevalence of dementia is 6% to 10% of people over 65, and thereafter continues to increase with age. The number of people aged 65 years and older is expected to increase from 35 million in 2000 to 71 million in 2030. The number of people aged 80 years and older is also expected to more than double,from 9.3 million in 2000 to 19.5 million in 2030.http://www.cdc.gov/pcd/issues/2006/apr/05_0167.htm

Failure to obtain advance health directives grievously impacts the lives of these patients and caregivers as well.

Early detection of dementia and early intervention to fully inform and ascertain the wishes of patients are therefore of great importance. Such efforts must be translated into public policy.

A face to face meeting between physician and patient or surrogate, clearly noted in the record, establishing an actual informed consent is the most reliable. This honors the patient's dignity, and also protects physicians and hospitals from claims of wrongful death or physicians assisted suicide.

Further comments by the authors of the study published in the JAMA study are available, at http://www.eurekalert.org/pub_releases/2010-02/bu-sec020810.php

Parental Liability for Failure to Seek Care for their Child

Bernard Freedman — Fri, 05 Feb 2010 16:52:25 -0800

A verdict was rendered yesterday (Feb. 2, 2010) in Oregon City Oregon finding Jeffrey and Marci Beagley, Oregon City's Followers of Christ Church, guilty of criminally negligent homicide in the death of their 16-year-old son, Neil. Their son died in June 2008 due to a chronic undiagnosed urinary blockage. Neil became significantly ill about one week before his death due to renal failure. He became weak, could not get out of his bed, and had pain in his abdomen and restricted breathing. Jeffrey and Marci Beagley’s Christian faith called for them to seek healing from the Lord and thus as Neil became worse his parents attempted to heal him with prayer, anointing with oil and laying on of hands. It was uncontested that earlier intervention would have saved his life.

A physician and bioethicist, Dr. Douglas Dickema, testified at trial that it was reasonable for the parents fail to seek medical attention because: "If you don't think your child is dying, you may not bring them to the emergency room." For example, he said: "It may take three days of (a child having) seizures to get them into my emergency room."

Dr. Dickema is the chair of the Committee on Bioethics of the American Academy of Pediatrics. It seems that Dr. Dickema did not testify as a bioethicist but as a physician who represented that he knew what was a reasonable expectation of when a parent should seek medical attention for their child. Legally, however, the standard is what a reasonable parent would do in similar circumstances.

It was often repeated during the trial that Neil himself told his parent that he did not want to go to the doctor. Aside from the fact that he was 16 years old, he did not have the benefit of being informed as to the risks, including death, of refusal of treatment.

A study at the University of California at San Diego from 1975 to 1995 found that of 175 children 140 children died because treatment was withheld based upon religious beliefs. There was a >90% survival rate of the children who died if treatment had be instituted.

Publically Managed Care found to be Superior to Private Managed Care

Bernard Freedman — Fri, 05 Feb 2010 07:37:56 -0800

Boston University School of Public Health researchers reported that older, male patients receiving care from the Veterans Health Administration (VHA) health care systems had better health outcomes than those in privately managed care plans that are part of the government-run Medicare Advantage program using private contracted managed care.

Two surveys were done on 107,300 men, ages 65 and older, between 1999 and 2003.

VHA care was found to be more effective that the privately contracted Medicare Advantage program. This was true for the average elderly male patient cared for in the VHA as well as for vulnerable sub-populations."

These sub-populations included those 75 years of age and older, and those diagnosed with hypertension, diabetes, coronary artery disease or chronic heart failure.

Patients receiving care in the VHA after two years were 3 to 10 percent more likely to be alive with the same or better physical or mental health than those in the Medicare Advantage program after two years of care, the study concluded.

Authors of the study: at Boston University School of Medicine and School of Public Health

Lewis E. Kazis, Sc.D. - Professor Health Policy;

Alfredo Selim, MD - Assistant Professor of Medicine

Dan Berlowitz, MD, Professor of Healthy Policy and Management:

James A. Rothendler MD, Assistant Professor of Health Policy and Management;

Avron Spiro III, PhD Associate Professor of Epidemiology and,

Donald Miller, ScD, Associate Professor of Health Policy and Management.

Same Sex Domestic Partners and Medical Decision Makers

Bernard Freedman — Wed, 03 Feb 2010 10:47:27 -0800

The Senate Judiciary and Public Affairs committee in New Mexico passed (5 to 4) the Domestic Partnership Bill - 800 pages long that gives unmarried same-sex and opposite-sex couples the legal protections and benefits of married couples on issues including medical decision-making. It is anticipated that republicans will oppose.

It must be made clear that patients are not restricted in nomination who ever they want to act as their surrogate decision makers. It is the person who best knows the patients wishes and values that should act as the surrogate decision maker in all instances.

Some states provide for priorities to family members, for example, calling for the spouse to make decisions, if they agree. The patient however can overrule this by nominating who they wish, irrespective of family or other relations.

Death Panels and Advanced Care Planning

Bernard Freedman — Tue, 26 Jan 2010 09:55:57 -0800

A recent article in the Journal of the American Medical Association, JAMA, discusses the need for effective public health announcements to encourage people to explain their end of life wishes and their values, goals and preferences. It has been well established that physicians are reluctant to discuss end of life choices with their patients and the norm has been to put it off until the patient is in advanced terminal disease when it is, indeed, more difficult to discuss. Studies have also shown that the majority of patients said they would choose to forego futile care but few are presented with this option.

The failure to have this conversation at an appropriate time may end up having the patient frightened and confused and unable to have a meaningful discussion after being fully and intelligently informed about the risks of further treatment and the progression of their illness and the physicians frightened to raise the subject late in the game and give their patient the impression that he or she is being giving up on.

Legislation was proposed in recent Health Reform bills requiring physicians to “offer” to discuss advanced health care planning was met with chants of “Death Panels” in the media partly as a result of prior vice presidential candidate Sarah Palin’s claim’s of “Death Panels.” She based this on President Obama’s choice for Chair of the NIH Department of Bioethics and concurrent, and seeming conflicting position, as White House Office of Management and Budget - Ezekiel Emanuel. Emanuel has forthrightly stated that young children and elderly should not receive basic health care, not only in times of epidemics or pandemics but in general as it applies to scarce medical (economic) resources. This was easy fodder for Palin’s accusations of death panels in proposed health reform legislation.

In the JAMA article Drs. Terri Fried and Margaret Drickamer; argue for public health announcements to urge advance care planning.

“Delivering these messages will require broad outreach,such as through the use of public service announcements.…Although the process of personal participation in ACP should take place on the clinical level with an individualized interaction between patient and clinician, the process of encouraging participation in ACP must occur on the population level

This will be difficult especially t this time because of recent increased mistrust of government proposals. In my view the trust exists between physicians and their patients and thus the answer lies in vigorous efforts to educate medical students and physicians in the need for, and the methods of discussing advanced care planning at an appropriate time.

Doctor's Mothers and Autonomous Choices

Bernard Freedman — Thu, 14 Jan 2010 23:47:51 -0800

Physicians continue to tell patients what they would do if it were their mother. This is just another form of paternalism and disregard for autonomous decision making.

Physicians remain exceedingly reluctant to confront the difficult subject of end of life care. The New York times, on January 11, 2009 published an article, by Denise Grady, - “Facing End-of-Life Talks, Doctors Choose to Wait.” Discussing a survey of 4,074 doctors who took care of cancer patients, who had only four to six months left, but was still feeling well. 65 percent said they would talk about the prognosis, but wait to discuss end of life preferences.

Dr. Daniel Laheru of Johns Hopkins Oncology Center explained: “The natural tendency is not to provide more information about this than you have to,” - “It’s such an uncomfortable conversation and it takes such a long time to do it right.”

Yet, delaying the discussion invites confusion as to what the patient wants, overwhelming grief for the patient, family and close friends and the wasting medical resources and results in unnecessary expense. Physicians must get used to using the trajectory of disease to guide them in choosing the right time to discuss patient "preferences" and not limit the discussion to the right to refuse treatment.

As Malcolm Fisher, Clinical Professor, University of Sydney, Intensive Care Unit, explained so well: “If you don't talk early you'll lose your voice.”

“If you don't talk early you'll lose your voice.”

Built into some legislation in many states interprets “autonomy” in end of life cases as the "dignity" to refuse treatment and avoid what is termed a protracted death – but not the opposite. There is generally not an explanation that a patient may demand the continuation of life sustaining treatment and make that clear in an advance health directive. This slant on autonomy has caused some patients to be fearful of obtaining, or even discussing, advanced health directive with their own doctors, leaving their physicians without the benefit of knowing their wishes. It is meaningless and ludicrous for physicians to guide their patient with an indication of what they would recommend to their mother. Saying "if it was my mother, I would..." is an irrelevant way around obtaining an actual informed consent.

Death Panels

The perception by many people, including physicians and nurses, is that advance health directives are used only to refuse life sustaining care. Thus, the feared “death panels” loom in the minds of many people. Many commenting and discussing advance health directives limit their discussion to refusing treatment, chanting the slogan of a "Right to Die." This is a misinterpretation of the "Patients Self Determination Act, passed by the United States Congress in 1990. There is no "right to die," there is a right to indicate, in advance, one's preferences for medical treatment if they are unable to make their wishes known during some future incapacity - this encompasses one's preference to receive treatment as well.

Clinical bioethicists must work to dispel this dangerous assumption. Forms provided by States and directives provided by hospitals or prepared by lawyers must make this conspicuously evident.

It is not the job of Bioethicists to emphasize the right to refuse treatment, but instead to make clear the right to deliberate, after being fully informed on all important issues, risks, alternative methods of treatment, and quality of life expectations. It is the job of Bioethicists to educate physicians during times of conflict as to the applicable ethical precepts and legal requirements.

We should use the word “autonomy” not as a conclusion, but as a starting point, not to merely ask the patient what they want to do, or a surrogate decision maker what they think is best, but to begin a process of communication including all consulting opinions to evaluate the risk to burden of disease and quality of life. This is where we may find what is really meant by the word dignity.

So, autonomy, then, is a concept intended to inform our approach to the patient as well as a basis to respect a patient’s perception of their own life.

It is critical for us to understand the capability of a patient’s or surrogate to understand and deliberate on the medical issues. Just because someone has been named as a surrogate decision maker does not mean that that person is capable of listening, deliberating and deciding. If not, they cannot legitimately act as a surrogate and can therefore, with proper documentation, be disregarded. A second surrogate is often listed in an advance directive. Otherwise there can be an effort made to identify another person who knows the patient’s values. If all fails, the ethics committee can be convened to assist the primary treating physician.

These issues must be sorted out, not assumed. Bioethicists should be able and competent to assist or mediate most controversies, as well as assist an ethics committee in considering the applicable ethical and legal issues.

Questions for bioethicists to consider:

1. How do we educate surrogate decision makers as to their acceptable roles and duties?

2. When should we decline to follow the apparent wishes of the patient, or the stated desires of the family?

3. When is it prudent to exercise what is known as the “therapeutic privilege” and turn to a more paternalistic approach to patient care?

The Near Future - maybe

Bernard Freedman — Sun, 06 Dec 2009 14:51:58 -0800

New Reform Medical Center

Serving your Community since 2010

Agreement and Release

As you enter this Hospital you understand, acknowledge and agree that this hospital rations medical care and services. This means that the hospital and physicians can determine that you may not be entitled to certain medical treatment, even if it is of benefit to you. Your physicians and hospital may conclude that medical costs to the community outweigh the benefits of the otherwise beneficial medical treatment for you, if one or more of the following criteria exist:

Age, (younger than 5 or older than 68);

Mental Abilities, (e.g., Dementia, Parkinson's disease, Schizophrenia);

Economic status, e.g., having exhausted all savings and home equity;

Your ability to contribute to the community in the future;

Non-existence of family and friends to object to our withholding medical treatments;

Other factors unique to you, personally.

Your understanding and acceptance of this agreement will benefit others of your fellow citizens through savings of scarce medical resources. Thank you for making medical care assessable for others.

I, (Patient’s Name) hereby release this hospital and any and all physicians who may participate in my medical care from any and all claims of negligence or wrongdoing of any kind.

Ezekiel Emanuel, M.D.

National Chief of Medical Reform

Dated: _______________________________

Patient/Power of Attorney/Surrogate

Approved by the US Government and Consensus Entities

The Proper Role of Bioethics

Bernard Freedman — Thu, 03 Dec 2009 08:08:12 -0800

In Bioethics we learn that the patient has a right to make autonomous decisions. There has, however, been a bias built into to applicable legislation in many states, which interprets “autonomy” as the dignity to refuse treatment and avoid what is termed a protracted death. This slant on autonomy and the right to refuse treatment can cause some patients to be fearful of having an advanced directive, or, cause death due to withholding of artificial life support when not intended or requested by the patient.

It is not, the job of Bioethicists to emphasize the right to refuse treatment, but instead the right to deliberate after being fully informed on all important issues risks, alternative methods of treatment, and quality of life expectations.

Similarly, it is not the job of a Bioethicist to assist in effectuating the perspective or opinion of a patient’s physician, but rather to educate the physician during times of conflict as to the applicable ethical precepts and legal requirements.

We use the word “autonomy” not as a conclusion, but as a starting of point, not to merely ask the patient what they want to do, or a surrogate decision maker on what they think is the patient would see as best, but to begin a process of communication including all consulting opinions and discussions of cultural and religious and personal beliefs about morality, human rights and fundamental ethical treatment and respect for the patient. This is where we may find what is really meant by the word dignity.

So, autonomy is a concept intended to inform our approach to the patient as well as a basis to confidently respect a patient’s perception of their own life. It is critical for us to understand the ability to proceed and understand, and the actual potential of deliberating on medical decisions by a patient. These issues must be sorted out, not assumed. The degree of explanation to a patient, and the duties of the patient’s physician, changes with each patient, the unique effects of the disease or illness in terms of the patient’s experience and quality of life. Issues of undue influence must a part of our consideration, including pressures from family and financial motivations on the part of utilization reviews and the like.

How do we educate the patient’s surrogates in their acceptable role and duties?

When should we decline to follow the apparent wishes of the patient, or the stated desires of the family?

When is it appropriate to exercise what is known as the “therapeutic privilege” and turn to a more paternalistic approach to patient care?

Each of these questions may open up a Pandora's box of problems, but nevertheless must be confronted with the assistance of Bioethics consultations, mediations, and assistance from appropriate consulting physicians.

The Case of Baby RM - Court Intervention in Bioethics

Bernard Freedman — Mon, 09 Nov 2009 13:40:33 -0800

This is the kind of case that courts dread. Baby RM has congenital myasthenic syndrome (CMS) and is on a respirator. The physician supports the mother’s request to terminally extubate. The father implores to the contrary. To make a decision the court must hear evidence, the kind of that will provide a clear picture of this child’s diagnosis and most importantly prognosis - short term and long term.

Before the court can make a ruling this dilemma is best brought before the hospital ethics committee to review this case in detail, hearing from any physicians who are most familiar with this child’s problems, for example, pediatric pulmonology, pediatric neurology and physical therapy who could possibly work with this child – or not. The ethics committee would properly be composed of physicians from a variety of medical specialties, lawyers, lay people and clergy.

Thereafter, a written explanation and recommendation would be provided. Quality of life at present does not necessarily reflect the probable quality of life in the future. This ethics committee process is designed to confront severe dilemmas in medicine with the experience of having done so numerous times before, should be of great assistance, both to this child’s physician, parents as well as the court - if still necessary.

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Kidney Transplants and Informed Consent

Bernard Freedman — Fri, 30 Oct 2009 11:40:14 -0800

At the 42d meeting of the American Society of Nephrology in San Diego this week, entitled “Renal Week,” Elisa J. Gordon, PhD, MPH, of Northwestern University presented a study on informed consent, that found that “kidney transplant consent forms are written at considerably higher reading levels than they should be.”

She is of the view that consent forms should be written at a 5^th to 8^th grade reading to ensure that transplant candidates are well informed about transplantation processes, understand the material, and can provide informed consent.

My concern is that many physicians see forms as a satisfactory replacement for actually sitting down with a patient and explaining, not only generalized information regarding kidney transplants but also the specific and unique condition, risks and prognosis for each patient.

Physicians must not labor under the impression that a form satisfies their legal and ethical obligations for a real consent based upon all material information. If the question of informed consent is ever raised in a legal setting that form will not solely provide evidence of an actual informed consent.

This process should not be delegated to a medical assistant to “get the form signed.” The format and language used should, as Dr Gordon stresses, be assessable by all. Care however must also be taken to document the informed consent process and an explanation provided of the ability and level of understanding the patient or his or her surrogate decision maker.

Informed Consent and Multifetal Reduction

Bernard Freedman — Sun, 18 Oct 2009 20:08:26 -0800

Informed Consent and Multifetal Reduction

by Bernard W. Freedman, Bioethicist

The New York Times ran a story on October 12, 2009, addressing the issue of multiple pregnancies after In Vitro Fertilization, IVF or intrauterine insemination IUI, and hormone therapy. This article by Stephanie Saul, “Grievous Choice on Risky Path to Parenthood,” follows the patient Amanda Stansel, who, after being told she was carrying six fetuses, decided to reject multifetal reduction and accept the risks for herself and her children.

Following IVF or IUI, multiple pregnancies occur 10 times the rate as it occurs in a natural cycle.

Multifetal reduction is the intentional termination of the life of one or more fetuses for the purpose of allowing the other fetuses to survive. The label of “reduction” is a euphemistic misnomer. Multifetal reductions are a statistically anticipated need to terminate one or more fetuses. A choice is made as to whether or not to terminate, and if so, which fetus or fetuses are selected and on what criteria that selection is made?

Up until the time Mrs. Stansel had an ultrasound neither she nor her husband Thomas were warned of risks of a multiple pregnancy, including multifetal reduction and the unique increased risks due to Mrs. Stansel’s medical condition. The ultrasound showed that she was pregnant with sextuplets.

Many people are desperate to have children and turn to artificial reproductive technologies for help. Unfortunately, many of these patients are not told of the ramifications a multiple pregnancy can have both for the mother and the child. Amanda Stansel was one of these patients who went forward with multiple embryo transfer without her informed consent.

Mothers often suffer significant physical problems which include severe bleeding and possibly death following multifetal reduction. Bereavement groups have been developed to deal with the guilt, fear and anguish over the loss due to ending the life of one or more fetuses or the difficult deaths or severe physical and mental disabilities that may follow for the remaining infants.

For the children, there are substantial increased risks of respiratory distress, intraventricular hemorrhage, bleeding into the brain with potential brain damage, dead bowel (necrotizing enterocolitis), developmental delays, cerebral palsy, and death.

So, what must physicians tell IVF and IUI patients who elect multiple embryo transfer?

Physicians must advise of all significant risks, including those risks that are unique to the patient that may increase the dangers to that patient and or the children who may be conceived. Physicians should not delegate the responsibility of obtaining an informed consent to medical assistants or leave it to written explanations in handout brochures in the office.

The physician must ensure and document that the risks are understood in realistic detail including the eventuality of the need for multiple fetal termination by injecting potassium chloride into the vascular system of the fetus and ending its life. The patient must understand that this risk can be avoided with single embryo transfer.

Physician Liability

Obtaining a real informed consent is difficult to do and it has been shown that most physicians are reluctant to do so. Nevertheless, if these risks are not fully explained and understood the mother cannot actually decide whether or not to proceed. The law prohibits any procedure from going forward without proper consent and it should be understood that liability for the injury, suffering or wrongful death of the mother or children could follow.

Terminal Extubation: Discussion and Protocol By Bernard Freedman, Bioethicist

Bernard Freedman — Sun, 06 Sep 2009 22:01:56 -0800

Transparency:

The salient ethical, moral and principle necessity to terminal extubation is the transparency of the conduct of all physicians and medical staff, and fundamental understanding by the patient family and or friends as to why it is being done and how it is being done. It is therefore the obligation of the primary treating physician (PMD) to assure full communication and full documentation.

All must keep in mind that the critical distinguishing factor between terminal extubation and physicians assisted suicide is the patient’s rejection (by the patient of patient's surrogate) of artificial life sustaining treatment followed by the alleviation of pain and discomfort of the dying patient. Unambiguous documentation must avoid any appearance of physician assisted suicide. Only by being forthright about these factors can real transparency exist.

It is the fundamental right of all patients to reject medical treatment after all risks have been explained and all options presented. It is this rejection of treatment by a patient that distinguishes the act of caring for the patient from assisting in a patient’s suicide. The principle of the “double effect” in the use of elevating doses of opioids that may depress the respiratory system that is intended to diminish or alleviate the patient’s pain is not considered assisting the patient to end their life. Although ordering of opioids may hasten death it is the intention of alleviating pain after and only after, the patient’s refusal of life sustaining treatment. After a patient is extubated, the goal of medical care must shift to the treatment of symptoms.

Families will receive complete explanations that death will occur after an unknown period of time after extubation. Whether a family should be present during terminal extubation may depend upon their complete understanding and acceptance of the act and its consequences. It is generally best to have family and friends leave the room at the time of extubation.

Protocol:

1. Terminal extubation can only be performed after a collective decision-making process. It should be discussed by a group, for example, Primary Treating Physician and any of the following; Consulting Pulmonologist; Respiratory Therapist; Bioethicist; Nursing Director of Critical Care; and Critical Care Nurses involved in the patient’s care.

2. If possible, at least a 24-hours period should pass from the time of the decision to the time of extubation. If a surrogate has made the decision, the surrogate must review, understand, sign and have witnessed a Form for Withdrawal of Treatment. It is wise to offer the opportunity for the surrogate decision maker to meet with clergy. In light of the recent case law it is appropriate to ask the surrogate decision maker if there is someone in the family who is objecting to the terminal extubation. This will serve to protect the patient life as well as the physicians and hospital from potential liability for terminally extubation of the patient when a family member is objecting. If this cannot be worked out court assistance may be necessary for the protection of all concerned. (A sample form is included below).

3. The PMD should personally perform or supervise terminal extubation. Involvement of the PMD reflects the importance of end-of-life care and sensitivity to the family. Terminal extubation therefore should not be seen or conducted as an everyday medical procedure. The PMD must be sensitive in providing any cultural or spiritual factors needed to allow the utmost respect and dignity to the patient, family and friends.

4. NOTE: Patients who are in a minimally conscious state or have a non-terminal illness will require the Ethics Committee to meet and confer directly with the PMD and relevant consultants and review all necessary medical records before a decision to terminally extubate may be made. In this regard the PMD and Ethics Committee must determine that there is clear and convincing evidence that the patient would reject artificial life sustaining treatment under the medical circumstances existent at that time. All family and friends who can be reasonably located will receive notice of the intent to terminally extubate and given at least 24 hours to object. If there is any objection, risk management and legal counsel will be consulted immediately.

Notification of Death

Notification of death should be delivered in person, whenever possible by the PMD. The family frequently must be contacted by telephone if they are not present at the time of death. Family notification may be accomplished by any physician or nursing staff and should be documented.

For an excellent discussion, see: http://www.google.com/search?client=firefox-a&rls=org.mozilla%3Aen-US%3Aofficial&channel=s&hl=en&source=hp&q=www.ethics.va.gov%2F...%2FNET_Topic_20050330_Terminal_Extubation.doc&btnG=Google+Search

Bernard W Freedman, Bioethicist

Exemplar Form

Withdrawal or Withholding of Life Sustaining Treatment Form: (2 pages)

Name of Patient: ___________________________________________

Date of Birth of Patient: _____________________________________

Social Security Number: _____________________________________

Medical Identification Number: _______________________

I, _______________________________, am the Surrogate Medical Decision Maker for_______________________________, (patient). I have met with the primary physician, _________________________M.D. and discussed the patient’s medical condition and prognosis. I have been advised that continued medical treatment will not improve the prognosis for recovery; will result in unnecessary pain and suffering and medically unnecessarily prolonging death.

I have been offered the opportunity to speak with other physicians who have participated in the care of the patient, if any, and/or to have a second opinion from another physician of my choice, or by a physician provided for me.

I have been offered the opportunity to discuss this decision with a Bioethics Consultant and/or to have this decision reviewed by the Medical Center Ethics Committee. I have also been urged to speak with clergy, other family members, and close friends, in order to discuss the wishes of the patient, and to consider any cultural and religious values.

After carefully considering all information I have determined that the patient would not want to continue to receive and/or accept life sustaining treatment. I have also determined that withholding and/or withdrawing life-sustaining treatment is in the patient’s best interest. I am not aware of any person who is objecting to this decision.

I hereby request and authorize the withholding and/or withdrawing of the following artificial life sustaining measures, while continuing with all appropriate palliative care for the patient: ________________________________________________________________________________________________________________________________________________

Name of Surrogate: ______________________________

Relationship to Patient: ___________________________

Signature: ________________________ Date: _____________

Witnessed By:

Name: _______________________,

Signature: ________________________ Date: _____________

Name of Primary Physician*: ____________________________,

Signature: ________________________ Date: _____________

Witnessed By:

Name: _______________________,

Signature: ________________________ Date: _____________

*“Primary physician" means a physician designated by a patient or the patient's agent, conservator, or surrogate, to have primary responsibility for the patient's health care or, in the absence of a designation or if the designated physician is not reasonably available or declines to act as primary physician, a physician who undertakes the responsibility.

Pay to Play - Cost Containment by Ethics Committees

Bernard Freedman — Sun, 12 Jul 2009 22:41:29 -0800

The Los Angeles Daily News, July 11, 2009, wrote, “One doctor, who chairs the Northridge Hospital Ethics Committee, did raise the important and relevant issue of excessive, costly, end-of-life care that has no potential for significantly extending life. If consumers had to pay a significant copayment, they might not demand unreasonable or unadvisable care."

http://www.dailynews.com/editorial/ci_12817975

If this physician actually said this, of which I am doubtful, then it must be pointed out that a decision to terminate life sustaining treatment based on or informed by economic considerations is unethical and of great concern. Discussions of terminating life sustaining treatment must be grounded in evidence of the patent's intent, degree of suffering, quality of life, etc., but certainly not by demanding payment from people to persuade them to stop medical treatment and die.

Bioethics deals with the application of ethical and legal principles in medicine, not economic expediency. Physicians, and ethics committees across the nation struggle to understand each patients needs and wishes: what dignity means to them,– their religious, ethnic and racial points of view - their fears, mistrust and sometimes misplaced trust which may result from the undue influence of family, friends, business associates and others. As the California Court of Appeals wrote: “…the decision must ultimately belong to the one whose life is in issue.”

There are many people who appropriately face the economic realities of everyday hospital services. Reducing medical costs, oversight of physician owned hospitals who often generate higher costs due to the ordering of tests which have an economic benefit for the physicians ordering the tests, defensive medicine, reducing medical errors that result in serious injury and run up unnecessary medical costs, sometimes for patients who will need specialized medical care for the rest of their lives.

But, it is not for the chair of an ethics committee to declare what life is worthy of receiving life sustaining care based upon economic principles. Physicians and ethics committees must deal with the individual patient, one patient at a time.

A Staged Approach to Withdrawing Life Support

Bernard Freedman — Thu, 11 Jun 2009 09:39:23 -0800

A South Korean Ethics Committee uses a staged approach to Withdrawing Life Support

In follow up to this blog’s April 23, 2009 post: “Letting the Conscious But Incompetent, Non Terminally Ill, Patient Die.” A South Korean hospital used a staged approach to consider the withdrawal of artificial life support based upon the condition of the patient.

On June 11, 2009 an Ethics Committee at the Yonsei University Severance Hospital in Seoul Korea decided to remove a 77-year-old woman in a vegetative state from a respirator in accordance with a Supreme Court ruling.

Severance Hospital President Park Chang-il said:

“Though we should comply with the Supreme Court ruling, the patient is not facing impending death. So after conducting several meetings, we made the decision,” … “Under the three-stage guideline for death with dignity we came up with, we will make a prudent decision for patients who are in the second stage like the patient in question.”

Stage 1: patients facing impending death due to irrecoverable diseases such as brain death or impairment of multiple organs.
Stage 2: Patients in a vegetative state on respirators.
Stage 3: Patients able to breathe on their own.

Life support for patients in the first and second stages will be removed when certain criteria are clear such as patient self-determination, family consent and the ethics committee’s conditions are met.

In the light of the case discussed in the April 23 post, ethics committee should be required to pursue, with greater scrutiny depending upon the cognitive level and medical condition of the patient. It is unlikely that the ethics committee in Seoul would have approved of discharging a conscious but incompetent, non-terminally ill patient and resultant death.

Remember: The greater the cognitive and medical condition of a patient, the greater the level of scrutiny that is required before life sustaining treatment can be withheld or withdrawn. The greater the ambiguity the more need there is to err on the side of protecting the patient and to err on the side of life. Such an effort serves to protect the life of the patient and protect physicians and hospitals from potential liability.

Daniel Hauser - and Medical Confidentiality

Bernard Freedman — Thu, 21 May 2009 10:15:29 -0800

I agree with the court’s rulings in the case of Daniel Hauser, highlighted in the media recently. In this case there is as absolute need to continue chemotherapy. It should however be pointed out that the Court ignored Mrs. Hauser’s demand for confidentiality and contributed to this case becoming a spectacle in the media and making Mrs. Hauser the focus of overwhelming media attention, pitting her beliefs against most of the country's. This injudicious conduct may have contributed to the panic of the mother to leave the jurisdiction and hide herself and her son.

The legal issues in this case are, as noted by Arthur Kaplan, from the University of Pennsylvania, on Anderson Cooper's program, are easy. Dr. Kaplan also noted that in many cases psychologists come on board and are generally successful in swaying the family and the minor patient toward recommended treatment. People struggle with medical decisions to withdraw and withhold medical care each day. Many of these dilemmas deal with children. Irrespective of the religious beliefs of the parents this child would nevertheless be required to undergo chemo therapy over the objections of the parents. If the parents were members of the Church of Christ - Christian Science or Catholics, Jews, Muslims, Jehovah's Witnesses - the same legal and ethical issues would have to be confronted.

Patients and their physician, family and friends need to feel free to turn to the court for assistance in controversies surrounding withdrawing and withholding medical care without fear of becoming involved in a media circus.

In this instance the parents adhered to beliefs of a Native American religion.Judge Rodenberg, without any legitimate connection with the legal issues presented, chose to publish his confidential question and answer cross examination of Daniel Hauser, on the court's web site, including inquiry about a Native American religion. This would not have occurred with other more traditionally recognized religions. There is no religious justification to withhold life saving treatment from a minor and the Judge had no legitiamate reason to make it a focus of inquiry.

The Judge ignored Daniel Hauser's right as a minor to confidentiality and this testimony should never have been published.

Daniel Hauser's physicians ignored their bioethical duties to utilize the services of a clinical bioethicist, a psychiatrist or psychologist to intervene and assist in facilitating the exchange of information regarding different treatments and the effectiveness, risk and effect on quality of life of these treatments verses the failing to treat.

If the testimony of Daniel Hauser is accurate, his personal physician never actually sat down with him and established a line of communication and did not engender a sense of trust.

P 25 of Daniel’s testimony:
Q. So he [Dr. Bostrom] did not actually tell you, you had cancer?
A. Right.

Q. Okay, so you learned of that from your mother?
A. Right.
…
Q. So you and Dr. Bostrom never talked to you like I am talking to you right now?
A. No.

Daniel was able to understand the purpose of his biopsy procedure, the necessity of determining and distinguishing types of cancer, the need for an ultrasound and that ultrasound reflected the possibility of a pulmonary embolism, which could lead to his death.

Page 39:
Q. There was a problem with your left arm at some point?
A. If I moved my arm too much or jerked it, it could break off and go to the heart and I could have a heart attack.

Q. Did someone tell you that?
A. Yeah, the nurse did... I think they did an ultrasound or something……… I think (my arm) was warm…they found it was a clot and they said that could cause problems if it broke loose?

So, after one time of chemotherapy he experienced significant illness, weakness, and was caused to fear for his life. The judge did not directly ask him nor did he indicate any conversation with his physicians in which he was told that his life depended on him receiving continued chemotherapy.

Notwithstanding his age and his inability to legally consent or refuse treatment, a 13-year-old patient should be told, on a level that he can understand, of the ramifications and risks of accepting or refusing therapy.

Medical Confidentiality:

On the issue of the medical confidentiality Daniel was entitled to have his medical care and medical history kept confidential. Notwithstanding his mother and/or father’s refusal of treatment, Daniel, through his mother demanded confidentiality. Mrs. Hauser specifically asked the judge to maintain confidentiality for her son.

Page: 60. Mrs. Hauser asked the court for a private conversation.

Mrs. Hauser’s demand: “I do not want this out of this room, okay?”

Judge Rodenberg responded:

“Well although you need to be mindful… my plan was to file a copy of the [Daniel’s testimony and medical information] … because – just so you are understanding, the public has a [page 61] legitimate interest in knowing what happened here today.”

The public, because of media attention, may be interested in a lot of things, yet, that does not mean that a patient loses his right to keep his medical care confidential. There is no evidence that Daniel Hauser ever put himself into the “public arena” and waived any confidentiality with respect to his personal life and/or medical care. Confidentiality should have been maintained.

If the court views that disclosure of information is necessary, than historically, the full name of the patient is kept confidential and the case is referred to as, for example, In re Daniel H.

For the Supreme Court of the United States, Justice Rehnquist wrote:

It is a hallmark of our juvenile justice system in the United States that virtually from its inception at the end of the last century its proceedings have been conducted outside . . . the public’s full gaze and the youths brought before our juvenile courts have been shielded from publicity. (Smith v. Daily Mail Publishing Co., 443 U.S. 97, 107, 99 S.Ct. 2667, 2671, 61L. Ed. 2d 399 (1979).

In West Virginia for example, in a case involving education records, the state Supreme Court of Appeals recognized the public policy of protecting the confidentiality of juvenile information in all court proceedings:

"we are loathe to allow one of the last bastions of privacy, juvenile confidentiality, to be diminished in the least bit,"

Unfortunately, normal and customary procedures for dealing with ethical issues in the medical community were not utilized and basic law protecting a child’s right of confidentiality were cast aside.

Bernard W. Freedman, JD, MPH

Life, for some in Texas, is Cheap

Bernard Freedman — Thu, 14 May 2009 22:10:17 -0800

HEALTH AND SAFETY CODE CHAPTER 166.039.

PROCEDURE WHEN PERSON HAS NOT EXECUTED OR ISSUED A DIRECTIVE AND IS INCOMPETENT OR INCAPABLE OF COMMUNICATION

For the most vulnerable patients, without friends or family, life for some medical patients in Texas, is cheap. On vague and specious grounds and without proper oversight or transparency, physicians may withdraw life sustaining treatment from a patient, even if the patient is conscious, talking, and aware of his or her surroundings. This statute allows this to occur if a physician treating the patient concludes that the patient will die within six months and there is no advance health directive to the contrary.

There is a fundamental liberty interest which permits a patient to refuse life-sustaining treatment. There is also a fundamental constitutional right, which each person has, to his or her life. This right is protected by the due process clause. Yet, Texas law makes a presumption that leads to an unjustified decision to withdraw life sustaining treatment. The statute declares that merely because a patient has not filled out or written an advance health directive does not mean they don’t want to die. So, under Texas law, a conscious, but incompetent patient will be allowed to die if a physician, with “reasonable” medical judgment decodes that the patient will die within six months. “Reasonable” medical judgment is a low standard for the death of a patient. It does not require a "probability of death" with 6 months – only a reasonable and unchecked judgment. Moreover, the available safeguards which would require the review by a hospital ethics committee, or a court of law, is not a hurdle that is required to be cleared before removing the patient from life sustaining care. As long as there is no advanced health directive, and no family or friend to object, a physician can order the cessation of life support, if a non-treating physician or a member of the ethics committee agrees. Nor is there any effort or requirement of due diligence that must be made to locate friends or family.

In looking at this statutory scheme we should keep in mind the words of another Texan:

"You do not examine legislation in the light of the benefits it will convey if properly administered,but in the light of the wrongs it would do and the harms it would cause if improperly administered."
Lyndon B. Johnson

A conscious competent patient (with a terminal illness) who asks for help to end suffering may not be helped by their physician to end her life. This is considered physician-assisted suicide and is prohibited by law. However, under Texas law, a conscious patient who cannot decide for him or herself, and therefore needs the utmost protection, can have life-sustaining treatment independently halted by their physician and die without violating the patient’s constitutionally protected right to life. To overcome a fundamental constitutional right a full and comprehensive review of all relevant facts, opinions, motivation, bias, undue influence, is guaranteed by the due process clause of the fourteenth amendment. Why were these safeguards unconstitutionally cast aside by the Texas legislature?

It is clear that the right of a patient to withhold or withdraw from any treatment, including life sustaining treatment, is predicated on a legal tradition protecting the autonomous decision to refuse unwanted medical treatment. However, we must be careful to make the distinction that the right to refuse treatment is the patient’s right, not the right of a physician or hospital, or legislature. A presumption that the patient would choose death rather than life seems to be founded on a legislatively created principle that people, without known friends or family, rights can be disregarded and that the economic interest of the state is sufficient to overcome life. The Texas law that permits a casual and unregulated state imposed medical decision making scheme is unconstitutional.

In most circumstances, there are no specific statistical data on death from a specific disease within six months. When there are one or more studies, they are based upon information gathered from different medical communities with different demographics . The data will vary based on the age, type, and extent of disease and with different accompanying disease processes. Nevertheless, this statue presumes that a physician, irrespective of her specialty, is aware of all studies, and that all studies are based on relevant and sound epidemiological principles, and sufficiently powered biostatistical results.

In this way, patients are left to the creative medical imaginations and empirical and anecdotal experience. which will vary between physicians, that will determine a decision of life or death.

Review by the entire ethics committee, with a written explanation, must be legally mandated. There is, at present, a Bill in the Texas Legislature to amend this statute, Section 166.039. A requirement for mandatory ethics committee review should be included.

The Texas statute’s 6-month standard is illusory and prone to ethnic, racial, socioeconomic status and age bias. This, more often then not, will be a member of a minority group, whose family and/or friends cannot be located, or the patient is simply alone. So, the statute targets the most vulnerable patients who need the highest level of protection.

Letting the Conscious But Incompetent, Non Terminally Ill, Patient Die.

Bernard Freedman — Thu, 23 Apr 2009 22:56:26 -0800

It must not be too easy to withhold life sustaining treatment from any patient. When it comes to a conscious patient, who is not suffering from a terminal illness, we have to be unquestionably sure we know what we are doing.

A consulting physician contacted me expressing great concern that a 60 year old female patient who would likely die without surgery was being discharged. He said, “The patient is not terminal and is treatable. She needs surgery to survive – probably amputation of one or both lower extremities. The family wants her to be discharged home for hospice care and be allowed to pass away comfortably. The primary treating physician agrees with the family that this is best for her. This is not right.”

The primary treating physician explained to me that he had been caring for this patient for many years. She has little understanding of her underlying disease. Her affect is flat. He thinks that she has complete occlusion of both popliteal arteries, gangrene, and will need an amputation of the left and possible the right leg. She has well-controlled diabetes; and recurrent VRE infections. She has bilateral pneumonia and bacteremia. She does not have the capacity to make her own medical decisions. The family wants her to be discharged home under hospice care and allowed to die comfortably.

I interviewed the patient and asked if she wanted to go home: she said “yes.” I asked her if she understood that she would most likely need to have an amputation of one or both of her legs if she was to survive. She said, ” if it is needed so I do not die – yes, I want that.” I asked her questions about her life and family. She answered all questions appropriately, albeit with a slow response and little emotion. Her son, the surrogate decision maker, felt that she would refuse further treatment “if she understood things.”

I urged a psychiatric (was she suffering from a major depressive disorder, negative or positive family experiences, expectations of family vis a vis her illness) and neurologic consult (was she suffering from some transient mental confusion, was any medication she was taking impacting her ability to communicate or consider her options, would waiting help?) be ordered. A consulting physician asked for an infectious disease consult. (was she suffering from metabolic encephalopathy accounting for her flat affect etc.). Thereafter a bioethics meeting could be arranged to consider all opinions to gain a overall understanding of her cognitive state. Physicians could ask questions of the family and vice versa.

A psychiatrist determined that the patient did not understand the nature and risks of her medical condition and therefore lacked capacity to make any decisions. Accordingly, her request for the surgery could be disregarded. I discussed with him the fact that she was a non terminal patient who was conscious and responding to questions. He responded that the patient’s son's demands for discharge without further care were “perfectly reasonable and appropriate under the circumstances” as her care would be an incredible burden on the family.

The primary treating physician agreed, explaining that he was overwhelmed with the complex and unrelenting medical problems that this patient had endured. It was clear to me that he cared deeply for this patient and had struggled desperately in treating her over the years. No further consults were ordered and the patient was summarily released from the hospital within moments of the conclusion of the psychiatric evaluation, without any further dialogue.

Ethical issues & Legal requirements:

Case law, legislation, bioethics protocols and literature have grappled, for many years now, over how best approach terminating or withholding life sustaining treatment. Most cases have confronted situations where a patient is in a persistent vegetative state, or a terminally ill patient who could avoid needless suffering and prolongation of the process of death. For example, the California legislature passed into law §4650 of the Probate Code, declaring that “…The prolongation of the process of dying for a person for whom continued health care does not improve the prognosis for recovery may violate patient dignity, and cause unnecessary pain and suffering, while providing nothing medically necessary or beneficial.”

In the conscious but incompetent, non terminally ill patient, however, these concerns do not apply. Nor are there any concerns here regarding demands for treatments that are medically futile. So, what are the ethical and legal issues presented in this scenario? A “best interest” criteria seems inapposite. We cannot ethically conclude that this patient’s best interests are served by allowing her to die. It may be seen as beneficial to her family to avoid the burden of physically and financially caring for her. Considerations of burden on families are important and relevant, but not a justification for death due to lack of treatment.

The basis for an autonomous refusal of further treatment requires a sufficient showing, at the least, that the patient has a clear and comprehensive informed consent, as well as time for reflection and deliberation, while understanding that death will likely follow if treatment is stopped. Case law refers to this level of proof in this situation as “clear and convincing evidence.” There, however, is no showing here that this patient would, if “satisfactorily” competent, refuse treatment. The psychiatric exam that concluded that the patient did not understand the nature of her disease process and the risks of treatment (and non treatment), did not establish anything of value. Yet, this brief, psychiatric exam was sufficient enough to allow this patient, over my strenuous objections and pleas to stop, to be put on a gurney and wheeled out of the hospital by her son within moments of the psychiatric exam, and with out a neurologic and infectious disease evaluation. This patient understood that if she did not have surgery she would die, and that she would require one or both of her legs amputated. She understood that and asked for surgery so she could live. What more must be required of her?

The California Supreme Court, in the case of Conservatorship of Wendland, required a showing by a conservator, of "clear and convincing evidence" that an incompetent, non terminal patient, would want to die, before life sustaining treatment could be withdrawn.

The lesson of this post, and the point to remember, is that the greater the cognitive and medical condition of a patient, the greater the level of scrutiny that is required before life sustaining treatment can be withheld or withdrawn. We can look at this by considering six basic categories of the condition of a patient:

1.   Terminal and Persistent Vegetative State (PVS);
2.   Terminal and Minimally Conscious;
3.   Terminal and Conscious;
4.   Non Terminal and PVS
5.   Non Terminal, and Minimally Conscious;
6.   Non Terminal, and Conscious

At each level, our degree of concern and the absolute necessity to delve further into the medical, personal, ethical and legal bases for the decision must escalate. Primary treating physicians have help available to properly and earnestly accomplish this. Consulting physicians, clinical bioethicists, hospital ethics committees, and if necessary, courts of law, are available to achieve an ethical, legal and life and death determination.

The greater the ambiguity the more need there is to err on the side of protecting the patient and to err on the side of life. Such an effort serves to protect the life of the patient and protect physicians and hospitals from potential liability.

Randomized Pediatric Clinical Drug Trials - Africa and America

Bernard Freedman — Tue, 07 Apr 2009 11:54:10 -0800

In 1996, Pfizer needed a randomized trial for a new broad spectrum antibiotic and sent a team of its doctors into the Nigerian slum City of Kano during a meningitis epidemic. It was represented, to be a "humanitarian mission.”

A team of Pfizer doctors arrived at the Nigerian camp where meningitis had killed at least 11,000 people. They set up near a medical station run by Doctors Without Borders who were providing standard treatment. At the Kano Infectious Diseases Hospital, 200 sick children were picked. Half were given doses of the experimental Pfizer drug called Trovan and the others were treated with an established antibiotic.

Eleven of the children died and many more, it is alleged, suffered serious side effects ranging from organ failure to brain damage. After two weeks Pfizer summarily left the camp. Pfizer denies these allegations. The company claims only five children died after taking Trovan and six died after receiving injections of the certified drug Rocephin, (ceftriaxone). It is alleged that parents were not told that their children were to receive an experimental drug. It is reported, by Pfizer, that consent was obtained from the Nigerian state and produced a letter of permission from a Kano ethics committee which was a document that was alleged to have been a backdated form approved by the committee for a medical trial performed one year after this incident.

Certainly, such conduct raises serious ethical questions, which reportedly targeted Pfizer with civil and criminal actions. In December 2000, the Washington Post published a lengthy examination of the trial. The Washington Post similarly found that Pfizer carried out the experiment on 200 children at a makeshift epidemic camp in the northern Nigerian town of Kano. The articles reported that Pfizer had no signed consent forms for the children and relied on a falsified ethics approval letter to defend the design of the experiment.

The Third Circuit Court of Appeals stated, regarding Pfizer’s conduct, that "the administration of drug trials without informed consent on the scale alleged in the complaints poses a real threat to international peace and security…and "fosters distrust and resistance to international drug trials, cutting-edge medical innovation, and critical international public health initiatives in which pharmaceutical companies play a key role. ... As this case illustrates, the failure to secure consent for human experimentation has the potential to generate substantial anti-American animus and hostility."

Comment:

The fundamental ethical predicate in randomized clinical trials is that, based upon the state of knowledge at the time, it does not establish that either arm of the trial is superior to the other. This is generally referred to as “equipoise” without which a randomized clinical trial may not ethically go forward. To administer an experimental drug to children with meningitis when an effective proven medication is available, needlessly and purposefully exposes patients to serious injury or death.

The attempt to avoid the legal protections for patients in the United States by carrying out randomized clinical trials in Africa, is particularly damning. We should, however, keep in mind that related problems exist in pediatric oncology Phase I Trials in the United States. Phase II and III trials analyze benefits and compare results to standard treatments. Phase I studies do not. They are, simply stated, experiments with no legitimate expectation of benefit to the research subject. In order to permit a child’s participation in a Phase I trial the law requires an informed consent to the parents or guardian. ( It is not legally clear whether a parent or guardian can consent to exposing their child to unnecessarily harmful experimentation.) Telling them about risks, however, does not discharge that requirement. It is an informed consent that must be obtained, not merely offered. It must be presented to the child and parents in an unbiased way, and it must also be comprehended. Neither research physicians nor the Institutional Review Boards (IRBs) have been effective in accomplishing this task.

The tendency of research subjects to confuse their participation in clinical trials with personalized medical care is commonplace. There is an inherent conflict of interest between research physicians and child research subjects due to a misconception that treatment will be provided. This conflict may be most severe when it involves pediatric cancer patients and their parents. Children suffering from a terminal illness, whose quality of life may be eroded by pursuing hopes for survival in a phase I drug trial, where no real hope exists, need rigorous protection. Their perspective is not only a product of hope but also the result of repeated and purposeful misrepresentations by researchers and university medical centers that research subjects in phase I drug trials will receive “treatment.” Experimental toxicity studies however are not treatment. This misrepresentation has often been referred to as a “therapeutic misconception.”

For many people a university medical center inspires a sense of awe and can engender their confidence and trust. This may account, in part, for a child’s or parent’s belief that there will be some benefit in participating in a Phase I trial. There is a tendency in the recruitment process in Phase I trials to exploit this trust.

In a study published in the Journal of Oncology (Perceptions of Patients and Physicians Regarding Phase I Cancer Clinical Trials: Implications for Physician-Patient Communication, three hundred twenty-eight patients and 48 physicians completed surveys regarding expectations regarding treatment outcomes. Although 95% of patients reported that quality of life was at least as important as length of life, only 28% reported that changes in quality of life with treatment were discussed with physicians. In contrast, 73% of physicians reported that this topic was discussed. As to risks of the Phase I trial, 91.5% of the physicians believed that they discussed the risks, while only 73% of the patients recalled discussing of risk.

Discordance Between Patients and Physicians About Consultation Content
                                                                      Physician       Patient
Discussion Topic                No.    %         No.    %             P*
Changes in quality of life with treatment              171    73.4    65    27.9    < .0001
Changes in length of life with treatment               140    59.6    69    29.4    < .0001
Changes in quality of life without treatment     145    62.5    67    28.9    < .0001
Changes in length of life without treatment        123    52.8    67    28.8    < .0001
Possible side effects from treatment               217    92.0   184    78.0    < .0001
Possible benefits from treatment                   212    90.2    185    78.8    < .0001
Possible risks from treatment                                214    91.5    170    72.7    < .0001
*McNemar’s test.

It is important to note that the word “treatment” is used with respect to a Phase I clinical trials. Yet, a Phase I Clinical Trial is not “treatment” it is experimental testing which, hopefully, will lead to a treatment.

IRBs are required by statute to determine, without any specific guidelines to help them, that there are adequate provisions for “…monitoring the data collected to ensure the safety of subjects." Yet, no monitoring is generally done by IRBs. The President’s Council for Bioethics found that:

" Amazingly, no one - not the director of NIH, the commissioner of the FDA, or a representative of the Pharmaceutical Researcher and Manufacturers of America - knows how many people participate in biomedical or other research studies in the United States each year. … no comprehensive data exist on specific aspects of research. No one can say how many research participants suffer serious, unexpected adverse events each year, either for a specific study or in general, and of those, how many sustain a permanent disability or die unexpectedly. "

The problem is perhaps best described by the Chairman of the Council, Leon Kass who, in his discussion with the panel of the President’s Council, raised the issue of simply being honest with research subjects:

"If one simply says ‘they are the only subjects that are possibly available to advance our knowledge,’ however truly necessary that it is as a condition for using them, the question is whether it’s sufficient and whether one doesn’t want to try some kind of honest way to elicit their identification with the enterprise and not simply exploit their desperation. It’s not an objection to proceeding with the research, but the question is: How should they be regarded? How should they be treated? How should they be spoken to?"

Hence, we must not labor under the misperception that lack of candidness and legitimate informed consent in clinical trials is limited to villages in Africa. Problems exist in the United States and must be seen as work for clinical bioethicists to improve the process of informed consent in Phase I trials, especially with children, and to put in place protocols to expose conflicts of interests.