Clinical Bioethics Blog : Bioethicist : Bernard W. Freedman : Medical Consulting, Ethics, End of Life Decisions

Dr. Nicola Riley is being held without bail in Utah following her arrest on December 28. 2011. She worked for Dr. Steven Brigham in New Jersey, who owns abortion clinics.   Both of them have been charged with the crime of murder for performing late-term abortions in Maryland. Their apparent modus operandi was to “start” abortions in New Jersey and complete them in Maryland where abortion laws are less stringent.

Maryland has a Fetal Homicide Law that permits murder charges to be brought against people who “intend to cause the death of a viable fetus, yet specifically excludes physicians carrying out abortions. Section 2-103(e)  Murder or manslaughter of viable fetus states:

Inapplicable to medical professionals administering lawful care. -- Nothing in this section subjects a physician or other licensed medical professional to liability for fetal death that occurs in the course of administering lawful medical care.

Reuters News reported on January 9^th that : Cecil County State's Attorney Ellis Rollins said the case could be the first of its kind to test Maryland's 2005 fetal homicide law, under which murder charges can be brought against people who intend to cause the death of a viable fetus. The charge of murder could only stand if the medical treatment – the abortion – was found to be unlawful medical care.

About 38 other states have similar statutes and for the most part, these statutes have been applied, as the legislature intended, in criminal cases where an intentional injury to a pregnant woman that kills a fetus would result in a charge for murder.

The cases against Drs. Riley and Bingham are seemingly intended to test the use of this statute in cases of abortion. This case is especially egregious, as 35 and 36 week term fetuses are alleged to have been found in the doctors’ freezer.

Charges include both first and second degree murder.

In 2003, the United States Congress passed the partial birth abortion ban act defining defined as any abortion where the death of the fetus occurs when the “entire fetal head or any part of the fetal trunk passed the naval is outside of the mother’s body.”

(a)    Any physician who…, knowingly performs a partial-birth abortion and thereby kills a human fetus shall be fined under this title or imprisoned not more than 2 years, or both.

In the 2007 case of Gonzalez versus Planned Parenthood, the United State Supreme Court in a five to four decision held that the congressional ban on partial birth abortion was not unconstitutionally vague and did not impose an undue burden on the right to have an abortion.

Under this federal statute, the penalty:

Any physician who, … knowingly performs a partial-birth abortion and thereby kills a human fetus shall be fined under this title or imprisoned not more than 2 years, or both.

It is unclear at this point what type of abortion was performed by Drs. Riley and Brigham. 

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July 27, 2011

ASCO Urges Policymakers to Protect Patient Access to Cancer Care from Debt Ceiling Negotiation Package

The American Society of Clinical Oncology (ASCO ) is deeply concerned about the proposed $3 billion in cuts to Medicare reimbursement as part of a debt ceiling negotiation package. If the cuts are put into place, patient access to cancer care will be threatened as previous cuts to Medicare have already caused oncology practices to close, consolidate and turn away Medicare patients.

ASCO is closely monitoring the situation, and advocating on behalf of oncology practices and patients. This week, ASCO placed print and online advertisements in Capitol Hill publications including Politico, The Hill, Roll Call and CQ. To learn more about all of ASCO's efforts on this issue, visit www.asco.org/protectaccess.

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The New England Journal of Medicine recently published an article entitled: “ The Palliative Care Information Act in Real Life,” (NEJM 364;No.20 May 2011), regarding a New York statute that requires a physician to have discussions of end of life treatment options with the patient when the patient is “terminally ill.” Alan Astrow MD and Beth Popp, MD, the authors of the article, are troubled by the phrase terminal illness. They argue that the definition in the statute is vague and an improper interference with the physician-patient relationship. The fact that they find the phrase, “terminal illness” troublesome, is troublesome.

The authors fail to understand basic concepts in clinical bioethics as well as case law as to the duties of physicians dealing with critically ill patients and the provision of information on all relevant and alternative methods of treatment. Perhaps they think like so many others, that end of life care planning is reduced, basically, to one question: If you are close to death and your brain is in a persistent vegetative state do you want us to remove you from life support or not resuscitate you if you go into cardiac arrest? This is not the case. A variety of options are available to patients who are critically ill. It is foolhardy to wait until a patient is unable to actually explain their wishes to the physician and allow an adversarial situation to be created between family members, friends, physicians and other medical staff, as well as possibly leading to referring the matter to the ethics committee, the hospital administration, or hospital attorneys.

A variety of options should be addressed as early as possible and relative to the disease trajectory. In addition to discussing the anticipated medical course, differing degrees of brain injury or damage, the likelihood of recovery and anticipated risks and treatment options and related issues of quality of life. The following are some suggested talking points:

a.     The selection of one person who will act as surrogate decision-maker: the patient must understand that the surrogate decision maker only has any say if the patient cannot speak for herself. It should be made clear that the purpose of the surrogate is to effectuate the wishes the patient, not the wishes of the surrogate. Additionally it should be made clear that the surrogate does not have to be limited to a family member.

b.     A patient has the right to know (subject to the therapeutic exception) applicable Evidence-Based Medical (EBM) information to help the patient understand and evaluate risks and benefits of various treatment options (including lack of treatment) based on clinically significant research, such as: cohort studies, double-blind clinical research, meta-analysis, etc.

c.     Discussion with family and clergy should be encouraged;

d.     Advise that he or she may seek a second opinion. Aside from the fact that the patient may or may not want a second opinion, offering to arrange one will often provide a sense of confidence in the physicians treatment plan.

e.     At some point in time the patient may want to be transferred home on hospice and die peacefully with his or her family rather than in the ICU. Thus, palliative care needs to be explained and the probabilities presented to the patient with respect to longevity and quality of life.

f.      Does the patient have any religious requirements that they wish to follow with respect to receiving pain medication that may or may not hasten death? Many patients are willing to receive pain medication but not to the point where it may hasten death. Others may want to receive all necessary pain medication and sedation should be kept as pain free and comfortable as possible.

g.     Does the patient have religious convictions with respect to receiving blood or blood products?

And so on.

The rights of patients to make their own medical decisions create reciprocal duties on the part of their physicians to respect and uphold these rights.

The authors argue that there is a “standard of care” that dictates when physicians must tell their patients all relevant medical information. This is not true.

The standard is not determined by the medical community, but rather, by the patient him or her self. It is not a medical question; it is a personal, individual and unique decision by the patient, of which can only be made if all medical information and options or explained.

As one commentator advises physicians: “If you don’t speak early, you lose your voice.” Carol Taylor, RN, PhD advises patients: “For someone who sits with families trying to make these life and death decisions, I can say that planning is the greatest gift to your family.”

What is it that stands in the way of early discussion for many physicians?

The authors of the article, Drs, Astrow and Pope, claimed that:

 “… physicians need to feel comfortable communicating their values and experiences and providing non authoritarian guidance and support while expressing interest in and respect for the experiences and values of patients and families.”

This statement is ignorant of the law, foolish and, moreover, it is surprising that the NEJM would publish this misguided advice.

Physicians do not have to feel comfortable. What difference does it make if the physician “feels comfortable” or not when carrying out his or her responsibilities. Many physicians, if not most, will never feel comfortable in such situations. What is important is that the patient is not “comfortable” and may be fearful, confused and in need of all necessary information. (Without the provision of all relevant information, there cannot be any informed consent and the physicians may be found civilly liable in addition to incurring state imposed fines).

Secondly, it is clearly inappropriate for a physician to convey his or her values to the patient. A physician’s values are of no moment whatsoever. It is, on the contrary, the patient's values alone that should guide decision. Indeed, physicians’ values should not even be discussed or mentioned. If so, the patient would receive different guidance dependent upon which physician’s door she walks through.

Thirdly, the physician is always in a position of authority.  The author’s suggestion that they can counsel a patient in a non-authoritarian manner will not work. That cannot be avoided. So, any suggestions, as to a physician’s values must be avoided. The values of the physician are not in issue.

The decisions of the patient should as John Stuart Mill once describe, be a product of  “…free, voluntary and undeceived consent and participation…”

The authors provide us with a scenario of an 85-year-old man with gastrointestinal cancer that had metastasized to the lung.

“… when his cancer and its spread were diagnosed two years ago,

 he was already frail.”

At this point, if not long before, the patient should have been given the opportunity to consider many of the types of questions listed above.

The patient may have benefited from the knowledge, for example, that in a recent study of the 151 patients with metastatic non-small cell carcinoma, early palliative care led to significant improvement in quality of life and mood and that patients receiving earlier palliative care and less aggressive care often had longer survival rate.” If this 85-year-old patient with metastatic lung cancer was not presented with these and like information from applicable and relevant and authoritative studies, then the patient lost the opportunity to have longer survival and improved quality of life.

Finally, Drs, Astrow and Pope are concerned with the interference of the state into the practice of medicine. I agree that interference of the state into the practice of medicine is something that must be vigorously challenged. In this situation, however, the statute refers to the necessity of ensuring the rights of patients rather than medical practice

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The New Jersey Superior Court–Appellate Division dismissed the appeal in Betancourt v Trinitas finding the appeal moot. The court stressed it's concern over the  “sparse record” presented at the time of  the original hearing in the trial court as well as on appeal and found that the evidence was not “conclusive in several areas necessary to fully adjudicate the substantial issues raised.” This is sometimes referred to as insufficiency of evidence. If the person or entity bringing the case does not provide sufficient evidence the court will dismiss the claim. In this case Tinitas Hospital's request to withdraw the ventilator.

 Ruben Betancourt, 72 years old, was unconscious following the dislodging of a ventilator breathing tube after surgery at Trinitas Medical Center, which resulted in anoxic encephalopathy. He was readmitted to Trinitas in July 2008 with a diagnosis of renal failure. He received dialysis treatments, remained on a ventilator, and feeding tube. The physicians at Trinitas diagnosed Mr. Betancourt as being in a persistent vegetative state and told the family of their intention to stop dialysis and allow him to die.

 “We do not decide the issue but raise it to emphasize why the “thin” and disputed record is so critical to a full analysis.”

The Superior Court in New Jersey (trial court) held a two day hearing and thereafter enjoined the hospital from withdrawing life support without the consent of Betancourt's daughter, Jacqueline, who was appointed his guardian. Mr. Betancourt remained at Trinitas, on the ventilator, receiving dialysis and on a feeding tube until his death in May 2009. The case nevertheless went forward because the attorneys argued that this dilemma is a common occurrence and needs to be clarified by the court.

What this court clarified is that insufficient evidence was presented to consider the issues of withdrawing life-sustaining treatment.  As I pointed out in my previous post: 

            “… the physicians caring for this patient are required to place before the surrogate all medical evidence.

1.        CT and MRI scans,

2.        EEGs,

3.        All respiratory records and any potential to wean him from the ventilator. 

4.        Does he have a tracheostomy?

5.        Are his serious bed sores being tended to or ignored?

6.        What infectious disease is he suffering from?

7.        Is he responding to antibiotics?

8.        To what degree was his brain damaged due to anoxic encephalopathy?

9.        Has the physicians and or hospital discussed the events leading up to the hypoxic event, or hid from it because of concern of liability.

10.      Has all evidence been preserved, provided to the surrogate

11.       Has the ethics committee reviewed the case? If so where is their written report, findings and recommendations?

12.       Have bioethicists and or lawyers participated in conferences with  surrogate?

13.           ETC.

The surrogate cannot perform the job of a surrogate in the dark. This is where detailed records of the conversations and meeting held with the surrogate, family and physicians and reports from the ethics committees are critical to the surrogate’s understanding the issues in order to make a legitimate decision.”

"The uncertainty and lack of true consensus as to Rubin's condition may generate a result that will not only apply to a patient in a non-cognitive, vegetative state, but to a patient who is impaired and in possession of some level of awareness.”

Attorneys representing the hospital chose not to bring necessary evidence. Attorneys pick and choose what evidence they wish to disclose as favorable to their client’s position. We can only surmise that the evidence not produced was not favorable. It is often said that bad facts make bad law. A case of great importance to so many must be decided on clear findings of fact.

“…the judge concluded that Ruben was unconscious and in a persistent vegetative state. As it was not necessary to the decision that he reached, the judge made no specific findings, however, concerning Rubin's ability to perceive pain or react to his surroundings. The uncertainty and lack of true consensus as to Rubin's condition may generate a result that will not only apply to a patient in a non-cognitive, vegetative state, but to a patient who is impaired and in possession of some level of awareness.”

The absence in evidence of the usual procedures when an impasse is reached between physicians and patients is to call for help – from consulting bioethicists and ethics committees who will bring to bear physicians of various specialties, lawyers, lay people and clergy from the community. The surrogate decision maker would then have the benefit of views - and the reasons therefore – to consider facts outside any adversarial proceeding.

There was no indication that this review or participation of the bioethics consultant, or even be ethics committee, was involved in the attempt to resolve the dispute between the patient's surrogate and be patient's physician.

Thus, the attorneys representing the hospital did not give to the trial court sufficient facts to make a decision to the grant the withholding of life-sustaining treatment to Mr. Betancourt. .  As the court said in the opinion in this case: “We do not decide the issue but raise it to emphasize why the “thin” and disputed record is so critical to a full analysis.”

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 Ruben Betancourt, 72 years old, was unconscious following the dislodging of a ventilator breathing tube after surgery at Trinitas Medical Center, which resulted in anoxic encephalopathy. He was readmitted to Trinitas in July 2008 with a diagnosis of renal failure. He received dialysis treatments, remained on a ventilator, and feeding tube. The physicians at Trinitas diagnosed Mr. Betancourt as being in a persistent vegetative state and told the family of their intention to stop dialysis and allow him to die.

The Superior Court in New Jersey held a two day hearing and thereafter enjoined the hospital from withdrawing life support without the consent of Betancourt's daughter, Jacqueline, who was appointed his guardian. Mr. Betancourt remained at Trinitas, on the ventilator, receiving dialysis and on a feeding tube until his death in May 2009. The case nevertheless went forward because the attorneys argued that this dilemma is a common occurrence and needs to be clarified by the court. Oral argument was heard in May 2010. The opinion is pending.

 The Wall Street Journal has followed this case, and The Huffington Post ran a column by Jacob Appel yesterday regarding questions of end of life duties and responsibilities of physicians, patients, surrogates, ethics committees and hospitals. The case is Betancourt v. Trinitas Hospital – and should be decided by the New Jersey Court of Appeals any day now. Mr. Appel casts the issues in this case as an economic problem:

“Are there circumstances in which patient autonomy, as expressed through surrogates, should be overruled in the name of resource allocation and/or sound medical practice? If such rare circumstances ever exist -- and I believe that they do -- then Betancourt v. Trinitas offers an excellent vehicle for the courts to clarify the circumstances under which hospitals may override patients and families.”

Firstly, neither this case nor the appeals court opinion should be used as a ”vehicle” to establish policy. Courts do not make policy; rather they apply and interpret the law. The issues here do not pit life v economics or medical care v rationing of scarce resources. It, rather confronts the proper application of the law – which is quite clear – that the decision rests with the patient. Doctors practice medicine they do not make personal decisions for other people. Nor do courts. The patient’s autonomous decision is a fundamental right that cannot be ignored and should trump other important but not fundamental rights guaranteed by the by the US Constitution.

The appropriate question that should be before the court is whether or not the surrogate decision maker, in this instance Mr. Betancourt’s daughter, was actually carrying out the duties and responsibilities of a surrogate. The job of the surrogate requires that he or she be able to, and actually does, understand the medical issues applicable to the treatment decisions that must be made. Without this understanding and the risks and burdens for the patient, the surrogate does not have the capacity or ability to speak on behalf of the patient.

Similarly, the physicians caring for this patient are required to place before the surrogate all medical evidence.

1.              CT and MRI scans,

2.               EEGs,

3.              All respiratory records and any potential to wean him from the ventilator. 

4.              Does he have a tracheostomy?

5.              Are his serious bed sores being tended to or ignored?

6.              What infectious disease is he suffering from?

7.              Is he responding to antibiotics?

8.              To what degree was his brain damaged due to anoxic encephalopathy?

9.             Has the physicians and or hospital discussed the events leading up to the hypoxic event, or hid from it because of concern of liability.

10.           Has all evidence been preserved, provided to the surrogate and brought before the court

11.           Has the ethics committee reviewed the case? If so where is their written report, findings and recommendations?

12.           Have bioethicists and or lawyers participated in conferences with physicians and the surrogate?

13.           ETC.

The surrogate cannot perform the job of a surrogate in the dark. This is where detailed records of the conversations and meeting held with the surrogate, family and physicians and reports from the ethics committee are critical to the surrogate’s understanding the issues in order to make a legitimate decision.

However, the issue of the adequacy of Ms. Betancourt’s conduct as a surrogate is not an issue brought before the court and will not therefore be decided on that question. The surrogate stated that Mr. Betancourt is a fighter and would want to fight on. But, fight on toward what purpose? The question here is whether this patient would want to continue to receive arguably futile care because of some realistic hope of survival, or to sustain life because of some religious conviction notwithstanding the diagnosis of a persistent vegetative state, or other values. Merely proclaiming that her father would want to “fight on” and keep his body alive under these circumstances is not enough to establish that she has been fully informed – no different from what every patient in this country deserves from their physicians.

Such dilemmas are not uncommon. Indeed they occur thousands of times every day in this country and throughout the world. Yet, the appeals court questioned this point at oral argument. And, unless it is a common question that needs to be clarified, then there is no reason for the court to issue a substantive opinion.

This case needs to be adjudicated on the facts and admissible evidence and not be made in to some cause célèbre or some “vehicle” to push other’s policy agendas.What must be understood by all is that end-of life cases are deeply personal matters requiring both compassion and forthrightness and transparency by all.

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Red Flags Rules require financial institutions and businesses that give credit to consumers to establish some sort of program or procedure to identify customers who may be involved in identity theft. Since most medical providers provide medical services and allow the patient to pay their bill at a later time, and in concert with insurance benefits, the FTC intends to treat medical practice as a “creditor” and thus come within the scope of Red Flag rules. “Creditor” is defined by this law as any business or organization that defers payments for goods or services.”

On May 21, 2010 the American Medical Association (AMA) filed suit against the Federal Trade Commission (FTC) to exclude medical practices from red flag - identify-theft - regulations.

The AMA argues that physicians are forced by the realities of practicing medicine to defer payment for medical services rendered and that it “would violate the norms of human decency, not to mention principles of ethical conduct...for a physician to demand payment at the time of service in such situations."  This argument will not fly too far. The FTC is not forcing physicians to cease the custom of deferring payment, only that reasonable procedures be established to “red flag” potential or suspicious patients who may be involved in committing identity theft. The FTC says red flags rules are needed to prevent “medical” identity theft.

At this point, we must determine what would have to be done in order to identify or red flag a suspicious patient and whether or not it would interfere with a practice of medicine. The ethical problem in imposing red flag obligations on physicians is that it may set up an adversarial relationship between patient and physician. Questions would have to be asked by physicians or office staff to investigate suspicious account activities, suspicious identification, and so on.  If some suspicion is aroused the medical office would arguably be required to contact some law enforcement entity or FTC or the like, to report concerns.

All of these questions raise significant concern as to the effect it may have on marginalized populations. The difficulty may not be, so much, in obtaining general information by medical office staff, but the inhibition or intimidating chilling effect it may have on patients seeking medical care to be asked for various forms of identification, proof of residence (telephone bills, gas company bills, canceled check for rent and the like). Also, Red flag rules  imposed on medical practice may be used to uncover immigration status. We must keep in mind that it is not the finding of actual identity theft that is the problem but the investigatory process required by red flag laws that will intimidate and frighten patients (children included) from obtaining medical care.

Uncovering identity theft, as well as immigration status are of great importance to the safety of our economy and to prevent economic hardship or devastation. But, it should not be the job of the medical profession to participate in non-medical investigatory inquires. Strict rules applicable to the privacy of medical records are in place under HIPAA.  

Similarly, if a physician or physicians group is put on notice by some law enforcement agency, of potential perpetrator - whose names may be the same or similar to a patient -  of Identity theft such will require the physician to pursue some investigation and report back to the agency with his or her findings. The need for medical care should not be thwarted by fear.

There are significant incentives for physicians to establish some procedure for red flagging patients. The Federal Trade Commission penalties for red flag rule of violators range from $2500 to $3500 per violation.

The issue here is not the good that can result from imposing these otherwise important laws to protect against identity theft, but what bad can result from foisting non-medical responsibilities upon the practice of medicine. It will result in damage to the profession of medicine, the sanctity of the doctor - patient relationship and public health.

There has been ongoing controversy over these laws. On May 28, 2010, the FTC again delayed the implementation of the law until December 31, 2010. The lack of clear definitions as to who is and is not required to pursue some red flag program is the primary reason for the delay. 

Bernard W. Freedman, JD, MPH

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Each patient deserves more than a brief discussion about end of life decision-making. In  “A Piece of My Mind” section of this month’s JAMA (volume 303, No.13, April 7, 2010) Paul Kettl M.D. argues for monetary compensation to be provided to physicians for end of life discussion and planning. He fails to make clear, however, that the decision rests with the patient, not what is best for the family.

Physicians must be careful not to wear too many hats and should turn to skilled clinical bioethicists and if necessary the Hospital Ethics Committee for review and recommendations. This will protect the patient’s interests and dignity and the physicians involved in the care from liability. Legal and ethical issues applying to the withdrawal of life sustaining care have become increasingly nuanced and face greater scrutiny and need for transparency. So physicians must be careful not to change hats from physician for the patient  to physician for the family.

Once a patient losses capacity to make medical decisions, many physicians down play patient wishes and seek instead to satisfy family needs. It is not the degree of burden on the family that must inform decision-making. It is what the patient wants that prevails. The patient remains the patient, not the family.  Indeed, it often relieves the family and friends from the overwhelming burden of “deciding” what will happen with respect to withdrawing or withholding life sustaining care. In my experience, surrogate decision makers feel more in control and can make more informed decisions if they are told: “This is really not your decision. We are not asking you to decide if your wife should live or die. We are asking you, because you know her best, to tell us what she would want if she could speak for herself. In order for you to do that the physicians caring for your wife will tell you all the important medical factors, just as they must tell any patient.”

Different disease processes have different disease trajectories that allow the physicians to plan – with their patient - for medical decisions that will have to be confronted down the road. For example, different types of dementia have varying trajectories of cognitive decline. Decline may run from 2.7 to 6.8 years from first diagnosis. Initially cognitive function may not change at all from 9 to 35 months. Thereafter rate of decline vary significantly among patients.  

Dr. Kettl, a geriatric psychiatrist, advocates for payment to physicians to spend the necessary time when patients still have the opportunity to contemplate and develop health directives with the advice and discussion with family and close friends. It is a time when a patient may ask detailed question of her doctor about: prognosis of quality of life; distinguish between ordinary and extraordinary treatment decisions. It is also the time to make non medical decisions including where the want to die, at home or in hospital; the desires for the timing of initiating palliative care and to withdraw or withhold treatment that may only serve to extend the dying process. Early discussion avoids fear that comes when decisions must be made quickly and without the benefit of the patient’s clear and autonomous choices.

Withdrawing care that will result in the death of a patient cannot be treated cavalierly. That is why hospitals must have in place well developed procedures and protocols surrounding any decision to withdraw life-sustaining care. Compensating physicians is crucial to allow specific time, and timely discussion, with the patient before loss of capacity sets in.    

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

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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.

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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.

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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. 

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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

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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 what they think 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.

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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. 

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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.

 

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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


 

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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.

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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.

 

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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.

 

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Advance Health Directive:

Patient has an advanced health directive, witnessed, notarized and in the format of a legal document done by his attorney, rejecting treatment if he has a terminal condition with the probability of death within a few months; and/or an irreversible condition requiring artificial life support. Patient’s daughter is designated as surrogate. The document is notarized.
This 84 year old man is admitted for pneumonia; dementia; depression; anemia; malnutrition; renal failure, and hypernaturemia.

History: Dysphasia, anorexia, ataxia, poor intake, altered level of consciousness, restless, hypotensive, shortness of breath, bilateral rales. He is unable to give any history himself.

Admitting: Diagnosis: Acute pneumonia on top of interstitial lung disease and bronchiectasis.
The patient is intubated and noted to have renal failure, thrombocytopenia, leukocytosis, anemia, and deteriorating mental condition.

Patient’s daughter advises that her father never wanted to be maintained on artificial life support. Options are discussed with daughter, who requests that a do not resuscitate order be instituted.
Daughter advises bioethics consultant that she is waiting to hear from doctors regarding their opinion as to whether or not the pulmonary condition is irreversible, as described in the advance health directive. If so she wants to refuse continued artificial ventilation. Pending the receipt of that information she requests that no tracheostomy be performed. She insists that the patient not be sent to a skilled nursing facility.

Nevertheless, it is recommended, and the daughter consents to a tracheostomy. Daughter has not, however, been told any opinion as to irreversibility of respiratory failure. Attempt at weaning is ordered and patient is extubated. He deteriorates and is reintubated the same day. Pulmonologist, without consulting patient's daughter, writes order that patient be transferred to a skilled nursing facility.

Daughter is advised by nurse about the transfer order and refuses transfer. She reiterates that her father would not want to live in a skilled nursing facility on artificial life support. Under these circumstances he would reject continued artificial ventilation. Daughter says she does not want futile care. Patient’s daughter, and bioethics consult request a meeting with pulmonologist. There is no response from pulmonologist, one-way or the other.

The pulmonologist ceases to participate in case without any discussion with daughter. Daughter requests and signs withdrawal of artificial ventilation form. Three days later the daughter is notified that her father has been extubated and transferred to a skilled nursing facility. She, however, is unable to locate her father at that facility and is told that her father "never arrived." She calls the hospital and is told that he is no longer a patient at that hospital. She thereafter discovers, through the nursing administration office, that her father has died and that his body has been in the hospital's morgue for 3 days.

Comments:

1.    Physicians as well as patients and family often have difficulty withdrawing life-sustaining treatment. The daughter never received an answer as to the probability of death or of the irreversibility of the patient’s condition - the criteria set forth in the advance health directive. Her decisions were not informed.She felt abandoned by the pulmonologist who seemed to "just disappear."

2.    There is no obligation for a physician to treat a patient in a way that is contrary to the physician’s conscience. A physician does have the obligation, however, to inform a patient, or if necessary a surrogate decision maker, as to the diagnosis and prognosis, including risks of treatment and of non treatment. Before signing off the case the pulmonologist, should have and easily could have advised the daughter that he was withdrawing from the case and discuss options, which should have included arranging for a new pulmonologist on the case.

3.    There is reluctance on the part of many physicians to discuss end of life care and options. An Institute of Medicine study on improving care at the end of life found that there is often:
a) Overuse of care that is inconsistent with patient preferences and prognosis;
b) Underuse of care to treat symptoms;
             c) Untimely referral to hospice;
             d) Poor palliative care;
             e) Poor communication regarding prognosis and treatment preferences.

In a cohort study of 1573 patients, prolonged ventilation was not generally discussed:
         12% of patients discussed preferences with their physicians,
         20% said that they wanted it,
         80% said that they did not want it.
Annals of Internal Medicine: 1 July 1997 | Volume 127 Issue 1 | Pages 1-12

4.    After withdrawal or withholding artificial life support, the need for palliative care must be conscientiously provided to patient and/or surrogate decision makers. Responsibility for patient care does not end with a decision to withdraw artificial life support.

5.    Support for family members should continue. This case illustrates that physicians can lose interest in a patient after a decision to withdraw or withhold life-sustaining treatment.  In this instance this may have contributed to the failure to maintain a line of communication with this patient’s daughter, including advising her of her father’s death.


 

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The patient, Larry M, is a man in his 40s with a wife and three children at his bedside. He is in end stage liver cancer. He has been receiving total parenteral nutrition and IV fluids and has now decided to have his feeding tube and IV fluids withdrawn and to then return home with his wife and children, and with the assistance of hospice, die as comfortably as possible. The patient feels that this is be best for him and helpful to his wife and children to go through this process with him. His physicians fully support this decision.

Before leaving the hospital, however, the patient’s sister flies in from out of state, distraught, angry, and out of control. She cannot accept that her brother is “going to give up.”  She vehemently expresses her disdain for the physicians and for her sister-in-law’s support of her brother’s decision to withdraw artificial nutrition and hydration and leave the hospital.  In the hospital room, sister begins to yell and throw chairs around the room.  The nurse calls security. The patient requests that his sister not be escorted out of the room, and sister agrees to “calm down.”  The sister, however, continues to subject the patient’s wife to verbal abuse. The patient does not want to expose his wife to this abuse, and is concerned that after his death there will be alienation of his wife and children from the rest of the patient’s family.  Accordingly, in order to appease his sister and to protect his wife, the patient agrees to remain in the hospital with continued artificial nutrition and hydration.
The original decision to return home was freely arrived at. His new decision to remain in the hospital is not.  Nevertheless, Larry M has changed his mind based upon factors important to him: namely, his wife and children’s future relations with his family and his sister’s anguish that he, in her eyes, do all he can to survive as long as possible.
It is not the duty of a physician or bioethicist to act as security guards or family councilors.  Bioethicists can mediate the impasse. A bioethicist could privately ask Larry M if he thought it might be helpful if he, and or physician, met with his sister and other family members to discuss the Larry’s terminal medical condition and his right to make unencumbered decisions, and also consider other approaches.

Approaches to consider:
Time is often an important factor. In this instance the patient’s sister has flown in from out of state, probably in a heighten state of panic and fear for her brother. Allowing some time to pass without argument or attempts at persuasion, may allow the sister to cool down to the point of being able to understand the reasons for her brother’s decision.

 
Medicine: Family members living far from the patient have not been a part of the medical care provided or the suffering that patients have endured over the course of their illness.  Apprising them, in some detail, of the long and arduous courses of treatment and make them feel a part of the process and part of the decision making process and enable family members to support the patient wishes and to move from anger and fear for her brother to support and compassion for the patient.
Physicians and nurses may tend to loose interest in patients after withdrawal of aggressive treatment, and may be seen as abandoning the patient. So, physicians and nurses should maintain ongoing and meaningful contact with the patient and family.

In some instances, it has been shown that patients, who would otherwise elect to withdraw from artificial nutrition and hydration, continue to request it in order to satisfy the concerns of family, notwithstanding abdominal discomfort and nausea. Discussions with family and physicians and nurses regarding concerns of withdrawal of artificial nutrition and hydration are generally helpful to the patient and the family.  

 

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According to the LA Times, four Japanese citizens, otherwise barred from entering the United States for criminal activities, received liver transplants at UCLA. There has been no statement as to whether these patients were on a waiting list, and if so, where they placed. Nor has it been revealed what the etiology of the liver disease was - the major consideration in determining the candidacy for the transplant.

 One of the patients, reportedly a Yakuza Gang Boss, was helped by the FBI to obtain a US visa in the hope that he would provide the FBI with information in return for arranging the surgery . It is unclear if the FBI assisted in facilitating the surgeries. Additionally a donation of $100,000 was made the patient to the UCLA Medical Center Discretionary Fund.

The surgeries were performed between 2000 and 2004, and in each of those years more than 100 patients died awaiting liver transplants in the Los Angeles area, according to the LA Times.

According to UCLA procedures for liver transplant: “… each patient's case will be presented at a weekly meeting of the UCLA Liver Transplant Consultation Team. This group includes specialists from surgery, adult and pediatric hepatology, cardiology, pulmonary, nephrology, hematology, infectious disease, psychiatry, as well as transplant coordinators and social workers. Thereafter, a determination is be made, to ensure the patient's candidacy for transplant.

Long-term survival is significantly affected by the etiology of liver disease. Without an appropriate assessment of the etiology of liver disease a waiting list becomes meaningless. There are clinically significant differences in the mortality risk ratio which are dependent upon a variety of disease processes as well as the age of the patient

Dr. Ronald Busuttil, the surgeon performing the subject liver transplants, reported in a peer review journal that the etiology of disease is determinative of ranges of the mortality risk ratio from 1.00 for PBC  to a mortality risk ratio of 3.50 for malignancy. Patients older than 55 (at least one of the patients was over 60 years of age at the time of surgery) have an increased mortality risk ratio of (RR 1.59) due to age alone.  
  
Questions:
1.    Should  UCLA be asked to disclose to the news media the listing criteria and etiology of disease of these four patients?

2.    Should the UCLA Ethics Committee have been consulted before these surgeries went forward?
 
3.    Should investigations by governmental agencies, be it the FBI or the Department of Home Land Security, be helped by medical centers in allowing informants to be placed at the top of the waiting list for organ transplant?  

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