Clinical Bioethics Blog

Can late stage abortions be murder ?

Bernard W Freedman, JD, MPH — Tue, 10 Jan 2012 23:36:46 -0800

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.

Rasouli Decision: We don't need permission to withdraw life sustaining care

Bernard W Freedman, JD, MPH — Tue, 27 Dec 2011 13:35:58 -0800

On December 22, 2011, the Supreme Court of Canada agreed to hear the case of Cuthbertson and Rubenfeld versus Hassan Rasouli. The appellants, Drs. Brian Cuthbertson and Gordon Rubenfeld) are Mr. Rasouli’s physicians.

The question before the court is whether physicians must seek approval from a legislatively created board of review before withdrawing a patient from life sustaining treatment. The statue was passed for a variety of reasons, including establishing a uniform standard of practice for the protection of patients across the country.

The review by the Consent and Capacity Board is only required if there is some objection by the surrogate decision maker. If the decision maker objects, he or she is required to follow principles of acting in the patient’s best interest as set forth in the “Health Care Consent Act.”

http://www.e-laws.gov.on.ca/html/statutes/english/elaws_statutes_96h02_e.htm

“...a health practitioner … may believe that the SDM (substitute decision maker) is not following these principles. If this happens, that person may apply to the board for a determination as to whether the principles have been followed and order to the SDM to comply with the act. Use of this application is limited to the health care provider of the incapable person (e.g. family members cannot apply to the board). Whenever an application of this type is received, the law provides that the patient is deemed to have applied for a review of his or her capacity to make the relevant decision…”

Purpose of the Health Care Act:

As a set forth in the appellate decision, the purpose of the Health Care Act is to establish rules that can be used consistently in all settings; provide and facilitate treatment, admissions, and other assistance for persons who lack capacity; and ensure a significant participation of family members when the person lacks capacity to make decisions.

The Consent and Capacity Board is an independent provincial tribunal created to adjudicate issues of consent in capacity and whether or not the substitute decision maker is acting in accord with the patient’s wishes or in his or her best interest.

There is no charge to the participants
Any party may attend
Family members and friends are also encouraged to attend.
Each party may have a lawyer, call witnesses and bring documents.
Each party, and the board members, may ask questions of each witness.
Thereafter, the board meets in private to make a decision.
The board will issue its decision within one day.
Written reasons will be issued if any of the parties request them.

Drs. Cuthbertson and Rubenfeld argue that the patient is in a persistent vegetative state and other physicians have examined Mr. Rasouli and agreed with this assessment.

They want to take him off life support and provide palliative care until he dies.

The decision maker argues that he is minimally conscious and remains aware of his surroundings and that if the physicians do not want to follow her wishes that they should apply to the Consent and Capacity Board and let the board decide whether the proposed course of action is in the respondents best interest.

A three day hearing was held in the Canadian Superior Court of Justice in February and March of 2011. The court found in favor of the respondent (Rasouli) and against the appellants Cuthbertson and Rubenfeld.

The court ordered that the question of continued life sustaining treatment must be referred to the Consent and Capacity Board, and, pending that decision the physicians were not permitted to withdraw or withhold life sustaining treatment nor place the patient in palliative care.

Rather than doing so, Cuthbertson and Rubenfeld brought their case to the Court of Appeals (Court of Appeal for Ontario, original case Rasouli versus Sunnybrook Health Science Center, 2011 docket number C53442).

Indeed, if they are wrong the patient will be dead.

Cuthbertson and Rubenfeld make two arguments to avoid compliance with the law:

1. “…if it is found that their decision to withhold or withdraw treatment falls below the requisite standard of care, they may be held accountable.” (Page 7 of the appellate decision). Indeed, if they are wrong the patient will be dead. The standard as set for the by the Canadian legislature, is to seek approval from the Board. The legislation protects physicians from being held liable:

If a treatment is withheld or withdrawn in accordance with a plan of treatment and with a consent to the plan of treatment that a health practitioner believes, on reasonable grounds and in good faith, to be sufficient for the purpose of this Act, the health practitioner is not liable for withholding or withdrawing the treatment.

2. Cuthbertson and Rubenfeld argue that withdrawing life sustaining care and prescribing a shift to palliative care is not “treatment” and that, therefore, no consent is needed to withdraw life sustaining care. Putting Mr. Rasouli on life support was a treatment decision and taking him off life support is a treatment decision, just as much as prescribing a medication for a patient and stopping the medication because it is not working.

Part 2 of this article will discuss the relevant ethical basis, legal reasoning and competing moral viewpoints.

Early Withdrawal of Life Sustaining Treatment in Severe Traumatic Brain Injuries, by Bernard W. Freedman JD, MPH

Bernard W Freedman, JD, MPH — Fri, 02 Sep 2011 08:49:33 -0800

CDC Statistics Traumatic Brain Injuries

On August 29, 2011 the Canadian Medical Association published the findings of a multicenter cohort study evaluating the withdrawal of life-sustaining treatment for patients who had suffered a traumatic brain injury. This study is of particular interest because by the nature of the injury patients cannot make decisions for themselves and generally such decisions in patients in end-of-life care have a variety of comorbidities which make an evaluation of the efficacy of the decisions to withdraw life sustaining care difficult.

720 patients were evaluated from six different major medical centers. Of the 720, 228 patients did not survive. 160 patients had life sustaining treatment withdrawn in the first three days of hospitalization.

In approximately 50% of the patients, deaths occurred within the first three days of admittance to the ICU. Most of the deaths were associated with withdrawing life-sustaining care (64%) yet the proportion varied significantly across the six medical centers, from 30.4% to 92.9%

Considering deaths due to withdrawal of life-sustaining care within the first three hospital days, an overall average of 45.6% occurred. However examining the outcomes from the six medical centers, the range of deaths due to withdrawal of life-sustaining care ranged from 22.2% to 59.1%.

According to the “medical teams” and who participated in the care, the reason given for withdrawing life-sustaining care was:

1. Poor chance of survival. (54.4%).

2. Prognosis was incompatible with the patient’s wishes. (33.8%)

3. A poor long-term neurologic prognosis. (28.5%)

These stated justifications are suspect because of the rapidity that decisions to withdraw life-sustaining care were arrived at. As the authors of this study indicate:

“in this specific population of patients, the decision to withdraw life-sustaining therapy made by patients’ relatives and medical teams is mainly based on prognostic information. Our findings are particularly concerning because many decisions to withdraw life-sustaining therapy were made early in our study: 64% of the patients who died within three days of admission to an ICU had life-sustaining therapy withdrawn. In some instances, this may be too early for accurate neuroprognostication.”

1. “Poor chance of survival. (54.4%)”

Means: She is probably going to die soon anyway, so let’s not wait and see, waste our time and costs, and extubate now.

This is a, " She is probably going to die soon so let's not wait and see and waste time and costs and extubate now" type of argument.

Yet, if the patient is going to die “soon” anyway, why not let her die without withdrawing the ventilator - for example. Waiting can only help us have a clearer picture of the degree of the damage and whether or not the patient will show any improvement in her neurologic status?

2. “Prognosis was incompatible with the patient’s wishes. (33.8%)”

This is a “He wouldn’t want to live this way” kind of reasoning. If the physicians for this patient could say to the family, something like: “I can tell you with authority that your son will never be able to have any modicum of awareness, he will never eat on his own, …” If this could be established then the “He wouldn’t want to live this way” reasoning may be an ethically sufficient decision, if in fact the wishes of the patient are clear. However, without such a established prognosis, how can we arrive at a reasonable assessment as to what, exactly, the patient would want. There is little ability to actually assess whether decisions to withdraw life support are genuinely the patient wishes or the wishes of others.

The question that must be posed is whether or not waiting will clarify the prognosis of the patient. If so, then it is indeed premature to withdraw. The fact that, as determined in this study, most patients die after withdrawal from ventilation support, serves to emphasize the need to wait.

“A poor long-term neurologic prognosis. (28.5%)”

This is a: “he probably will survive, but, …” argument. This is the worse excuse of the three listed. It states that: “he probably will survive and if we do not remove life support while he still needs it, someone will probably have to take care of him later. This is tantamount to homicide. We have a non-terminal patient with undetermined future neurologic status who we are going to withdraw life sustaining care to end his life. The total number of patients studied in this cohort was 720. 492 patients did survive, with considerable variability between the participating medical centers. The authors’ state:

“This raises the concern that differences in mortality between centers may be partly due to variation in physician’s perceptions of long-term prognosis and physicians practice patterns for recommending withdrawal of life-sustaining therapy.”

It is the job of the physicians to treat the patient, not satisfy the needs of the family. Hence, great care must be taken to determine and effectuate the wishes of the patient.

Patient Access to Cancer Care and Proposed Medicare Budget Cuts - Press Release

Bernard W Freedman, JD, MPH — Wed, 27 Jul 2011 15:12:59 -0800

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.

End of Life Care: the Doctor-Patient Relationship A Refusal to Communicate

Bernard W Freedman, JD, MPH — Thu, 23 Jun 2011 17:05:56 -0800

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

Rationing "scarce medical resources" and lying to the patient - do these go hand in hand? 7 comments

Bernard W Freedman, JD, MPH — Thu, 19 May 2011 16:20:13 -0800

Rationing "scarce medical resources" and lying to the patient - do these go hand in hand?

7 comments

Claudia Ruiz M.D • I don't think so, I'm from Mexico, and I have worked plenty with the mayan communities, they really don't have any acces to medicines o medical attention. We did our best to get them what they need, but sometimes it is impossible. Anyways, I never lie to my patients, they deserve to know the truth always. Maybe it is a different situation in the United States and the HMOs, but in principle, I don't think it is ethical to lie and withhold information to people, specially if that information is for the best of the patient.

Henry Levenson,M.D. • No, rationing health care does not equal lying to patients. It is better to explain to the best of your ability why referrals were declined or not authorized. Patients seem to assume that physicians are responsible for the reasons why health care is rationed.

M. Sara Rosenthal • In the U.S., rationing is usually not done according to an ethical framework (such as beneficence); it is usually done according to "ability to pay": if we were transparent about THAT -- we wouldn't have opposition to universal healthcare in the U.S. by the very people who could benefit from it. Transparency about access is really the issue.

Bernard Freedman, JD, MPH • Follow up Comment: Rationing : Withholding Medical Care by Lying to the Patient   "Rationing" of medical care and “triage” are different.   Triage prioritizes the use of limited medical resources when sufficient resources are not available.   Rationing is the withholding of available care for political/economic reasons.  With respect to rationing, therefore, it must be decided whether or not the patient is going to be told the truth.   The ethical question here is whether patients must be told that medical care is being withheld, or if a standard practice will sanction lying to their faces.  In his book “Pricing Life” Dr. Peter Ubel provides us with his definition of rationing. He says that the clinician must,  (1) Withhold, withdraw or fail to recommend a service that, in the clinician’s best judgment, is in the patient’s best medical interests;  (2) Act primarily to promote the financial interest of someone other than the patient, including an organization, society at large, or the clinician himself or herself, and  (3) Have control over the use of the medically beneficial service” (Pricing Life – why it is time for health care rationing, Peter A. Ubel, M.D., MIT Press, Cambridge Massachusetts 2000).  The phrase “withhold, withdraw or fail to recommend” defines rationing as outright dishonesty with the patient – violative of the legally required fiduciary role in physician-patient relationships.  So, I agree with Dr. Rosenthal that, indeed, transparency is the real issue

Marie Cartwright • Withholding, withdrawing or failing to recommend a service does not imply, in any way, dishonesty. It rather describes an informed attitude a physician will take towards a patient regarding a particular procedure and their candidacy for that procedure. A physician, for instance, can withhold a procedure from a patient while still being honest about the reasons for doing so, and rightly so.   In the UK, for instance, candidates for hip replacement surgeries are (or were several years ago) denied the surgery until they brought their BMIs down to a healthy level. In other words, obese candidates were denied hip replacements based solely on their weight. I initially struggled with this particular topic because it seemed to have a tone of infinite regression- patients who required hip replacements would have a much easier time reaching a healthy weight if they had a healthy hip! However, if the supply is far less than the demand, we must also take into account that obese patients who received a hip replacement would also probably need another replacement sooner than those within a healthy weight range.   In terms of honestly, however, the patient-doctor relationship cannot exist without trust. Lying should never be present, under any circumstances.

Bernard Freedman, JD, MPH • Thanks for the discussion. This is a growing quandary that calls for clarity from medical, ethical and public policy points of view. There is a difference between withholding or withdrawing efficacious treatment and telling a patient what you are doing and why, and “failing to recommend” an efficacious treatment and keeping it a secret under the guise of having what you call an “informed attitude.” So, I must ask, what is it that informs a physician’s attitude that justifies keeping the decision hidden? In other words lying to the person you have the highest duty to be honest with. Yet, you say in the next sentence of your comment that it is ok to” withhold the treatment while still being honest about the reasons for doing so.” I am unclear whether you are really saying that withholding the truth, lying, is acceptable.  You give the example of the obese patient who needs a hip replacement but is denied the surgery unless he or she loses the weight. The denial may be justified, but is the patient told the reason for the denial? Do you tell your patient that they must lose weight before the hip replacement will be permitted? Of course, I believe, you do. Otherwise there would be no incentive for the patient to lose the weight.  It is the trust aspect, the moral imperative of truth telling between physician and patient that is, I believe, at risk when rationing truly scarce resources.

Marie Cartwright • I think we are on the same page in many respects here. But, if I may clarify a possible misunderstanding- You said, "So, I must ask, what is it that informs a physician’s attitude that justifies keeping the decision hidden?" I definitely didn't intend to imply that physicians should keep their decisions, or reasons for their decisions, hidden. I believe quite the opposite. By informed attitude, I meant to refer to the physicians as "gatekeepers" who decide who can have what procedure, and when, and their decisions, or attitudes, are informed by factors solely about the patient. Physicians, after all, are the experts that we rely upon to help us better our health and in some circumstances, "save" us. In essence, and hopefully to answer your question, withholding a treatment and withholding the truth are two entirely different things. In my previous comment, I said that withholding a particular treatment is in no way dishonest. However, withholding a treatment without justifying or explaining it to the patient goes against the patient-doctor relationship and also is counter productive for any patient's treatment.   Regarding the hip replacement patients, I believe the the denial must, in all situations, be explained to the patient. I don't really believe that truth telling is at risk in any situation, much less the rationing situation. A patient must be told why he/she is no longer a candidate for a particular procedure. Even when supply is scarce, to be dishonest serves no purpose.

Rationing Medical Care Part II

Bernard W Freedman, JD, MPH — Mon, 28 Feb 2011 11:00:43 -0800

Efforts to encourage (or compel) physicians to lie to their patients were faced years ago when “gag clauses” were inserted into contracts between HMO’s and contracted physicians. The gag clause established a contractual obligation on the part of the physician to withhold information regarding treatment modalities that were not within the HMO protocol of allowable categories of care.

Contractually, it is common to exclude specific types or categories of care - “We will pay for this, we won’t pay for that.” Every contract of insurance has exclusions. Gag clauses, however, go further. They contractually bar physicians from fulfilling their fiduciary duties to the patient from making clear what relevant treatments are available in the medical community. If there were more effective treatments available, the physician nevertheless had to withhold such information. Physicians, therefore, had to choose whether to breach their fiduciary duty to their patient, or breach their contractual duty to the HMO if they revealed the availability of superior care for the patient.

For a patient, there was no real choice. No information that would enable a comparison between alternative treatments, nor any opportunity to confer with other physicians regarding alternative treatments.

This, to be clear, is fraud: purposeful misrepresentation and intentional withholding of critical information by a fiduciary and relied upon by the patient to his or her detriment, namely serious injury or death.

In 1990s, the AMA asked managed care organizations to withdraw gag clauses from their contracts with physicians. Though gag clauses have drifted, we hope, out of existence, medical rationing resurrects the same fraudulent behavior and, again, attempts to persuade or compel physicians to participate in the entire charade.

Patients will have to be told the truth unless our moral foundations of democracy are to be drastically diminished. If the informed consent process is genuine it must reveal to the patient all alternative methods of treatment – whether they can afford it or not. Patients are accustomed to being told that certain categories of treatments, though needed, may not covered by their insurance. If the policy is ambiguous then that issue of coverage can be legally and rapidly challenged.

Protocols to ration health care, if they surreptitiously contribute to the worsening of illness or death, will once again be an attempt by those who make policy to encourage or compel physicians to change from their absolute loyalty to their patient to become coerced agents of fraudulent socioeconomic policy.

Part III to follow: Efforts to Ration Care and Value Based Medicine

Clinical Bioethics - Rationing - the Ethics of Lying to the Patient - Part I

Bernard W Freedman, JD, MPH — Wed, 15 Dec 2010 08:55:44 -0800

Rationing : Withholding Medical Care by Lying to the Patient

Rationing of medical care and “triage” are different.

Triage prioritizes the use of limited medical resources when resources are insufficient for immediate treatment.

Rationing is the withholding of available care for political/economic reasons.

With respect to rationing, therefore, it must be decided whether or not the patient is going to be told the truth.

The requirement of informed consent cannot cease to exist because of political/economic policy. Nevertheless the degree of informed consent may vary with the degree and type of risk. Informed consent for a blood pressure medication may not require any specific discussion if the medications are reasonably the same in term of efficacy of treatment.

The physician has an affirmative duty to raise the question and answer such questions by describing all “available” treatment.

On the other end of the spectrum, withholding information about hemodialysis in a patient with multi-organ failure requires an explanation of all risks of treatment and non-treatment alike. Life expectancy, quality of life, prolongation of the process of dying and so on must be discussed in specific detail. Religious considerations may come into play as well. For example, some religious doctrines draw a line between “ordinary” and “extraordinary” care – ordinary care being required, where extraordinary care is not.

Nor can a physician simply wait to see if the patient inquires about other treatment that may be available. The physician has an affirmative duty to raise the question and answer such questions and breaking down “available” methods of treatment.

Part II will address policy considerations and legal ramifications of rationing medical care.

Withdrawing and Withholding Life Sustaining Care From Conscious, Non Terminal, Incompetent Part II

Bernard W Freedman, JD, MPH — Thu, 09 Dec 2010 17:52:56 -0800

Physician Liability: Withdrawing and Withholding Life Sustaining Care From Conscious, Non Terminal, Incompetent Patients – Part II

There are different standards that must be appreciated and respected before a physician can support a decision to withdraw life sustaining treatment from a non terminal and incompetent patient.

This scenario requires the highest degree of protection for the patient. Our fundamental rights are the most important when we are the most vulnerable. Patients in this category are weak, often confused and subject to the effect of bias and undue influence. When illness requires life sustaining treatment family members may experience sympathy for the patient as well as opportunity to end their burden of caring for the patient. Some family members have said to others: "you have done so much, your life has been put on hold, how can we afford to pay for this care, etc. This can result in a request to withdraw or withhold artificial life support for what may be seen as being in every one's best interest. This often occurs in adult children caring for an elderly parent or spouse.

This responsibility for caring for patients at home falls predominantly on women. Women often care for both an elderly parent and their young children at the same time. Many, as well, must work to support the family. Yet, this understandable burden cannot be used as a justification or rationale for the termination of life sustaining treatment. Physicians must never allow themselves to place the needs of the family above the best interests of the patient. Physicians must not allow family interests to become a guide to decision making – even if it results in volatile or abusive confrontations with, or threats by, family members.

Withdrawing life sustaining care from a conscious, non-terminal patient, even if competent who refuses artificial life support, is thwart with risk for the treating physician. In a California case that was ultimately decided be the State Supreme Court, barred withdrawing artificial nutrition and hydration from a minimally conscious, non-terminal patient when there was not clear and convincing evidence that refusing treatment would be what the patient would want if able to speak for himself.

The function of a standard of proof is to instruct the fact finder concerning the degree of confidence our society deems necessary in the correctness of factual conclusions for a particular type of adjudication, to allocate the risk of error between the litigants, and to indicate the relative importance attached to the ultimate decision…. Thus, “the standard of proof may depend upon the ‘gravity of the consequences that would result from an erroneous determination of the issue involved. …courts have applied the clear and convincing evidence standard when necessary to protect important rights.

The legislature in Pennsylvania dealt with this dilemma by specifically codifying a limitation on physicians precluding the withdrawal of life sustaining treatment in non-terminal patients whether competent or not.

Health care necessary to preserve life shall be provided to an individual

who has neither an end-stage medical condition nor is permanently

unconscious,… 20 Pa.C.S. §5462(c)(1).

If a demand is made by a surrogate decision maker to terminate life sustaining care in a non terminal, conscious and incompetent patient, physicians, as a matter of customary practice, should request immediate review by the ethics committee as well as an experienced clinical bioethicist, followed by written recommendation which should be placed in the patient's chart. This will provide support and protection against liability risk for all physicians on the case, and protect the patient. Thereafter, if there is any disagreement between the physicians, ethics committee member, bioethicist, or surrogate decision makers, or other family members or close friends, consideration should be given to petition the court for review.

Survival in Hospital Cardiac Arrest - Challenges for Hospitalists

Bernard W Freedman, JD, MPH — Thu, 07 Oct 2010 04:25:58 -0800

The September 2010 publication of “The Hospitalist” reviews the overall survival rates for cardiac arrest patients.

This article reports that patients frequently have unrealistic expectations and overestimate their chances of survival. Patients predict post-arrest CPR survival at 64%, while the rate is 17%. Most important is that in nearly half of the patients who initially expressed the desire for CPR, once they were informed of the actual estimates, they changed their minds and code status was changed.

It is difficult for many hospitalists to discuss DNR orders with patients. There is not a trusting relationship formed over time. Therefore it is often difficult to broach the subject with patient's or their surrogate decision makers.

For an in-depth and legitimate conversation leading to an informed consent to take place there must be a serious and comprehensive discussion of the patient's history and resuscitation statistics to the degree that they are reliable and clinically significant. The article notes that the “presence of hepatic insufficiency, acute stroke, immunodeficiency, renal failure, or dialysis were associated with lower survival rates.” The authors also note that survival rates are lower with metastatic disease and other malignancies.

Age and a history from prior skilled nursing facilities were associated with poorer survival rates and racial statistics also play a part in survival rates. This article discusses a study that reviewed the medical records of 433,985 Medicare patients 65 years and older who underwent in-hospital CPR. Patients 85 and older had a 6% chance of surviving hospital discharge. This, however, is a statistic and cannot be provided to patients without a detailed discussion of their specific medical condition. Survival rates tend to be lower in patients who are black/nonwhite. Blacks and nonwhites are reported to use CPR at a higher rate but with lower survival rates.

Most importantly, any discussion must include a description of the probable quality of life with post arrest survival. The authors take note that in post resuscitation survivors, in 86% of patients with pre-arrest cognitive abilities remain the same on discharge. Please note that a boilerplate prediction of survival will not pass legal muster.

A Cautionary Note: We should also be alert to the fact that some patients may tend to have a grimmer perspective of survival because of a diagnosis of a malignancy, albeit the cancer is in early stages and not immediately life-threatening. Fear of “cancer” does frighten patients to the point where they will opt for a DNR order prematurely when it may result in an unnecessary early death. Hospitalists, therefore, must include a detailed description of cancer staging, and in such instances take a wait and see position to allow the discussion to continue with the patient’s primary treating physician.

Withholding Life Sustaining Treatment: Letting the Conscious Non-Terminal, Incompetent, Patient Die: Hold On a Minute - Not So Fast - Part I

Bernard W Freedman, JD, MPH — Tue, 31 Aug 2010 11:23:22 -0800

It is an injustice to cause patients to unnecessarily prolong the process of dying. Actual futile care must be avoided. But it is equally an injustice to easily acquiesce to patient’s demands that my result in unnecessary death.

On August 17, 2010 the Supreme Court of Pennsylvania decided a case involving a non-terminal, profoundly mentally retarded patient. The patient was conscious and non-terminal. David is 53 years old. David's parents were the guardians.

His parents argued that putting him on the ventilator was not in his best interest and requested terminal extubation. The hospital refused. After several weeks his condition improved and he was successfully weaned from the vent.

David was diagnosed as having aspiration pneumonia and was put on a mechanical ventilator. His parents argued that putting him on the ventilator was not in his best interest and requested terminal extubation. David's physicians and hospital properly refused to follow these demands. After several weeks his condition improved and he was weaned from the ventilator.

Notwithstanding arguments that this case is moot, the court went ahead and rendered an opinion The Pennsylvania Supreme Court was asked to review the case to clarify the statutory scheme regarding the right of individuals to make their own decisions and to clarify the procedures for decision-making when a patient is incompetent.

The applicable statute required all things “… necessary to preserve life shall be provided to an individual who has neither an end-stage medical condition nor is permanently unconscious”

An attorney was assigned to David who argued that a Guardian's decision-making abilities should be consistent with the medical recommendations where the life of an incapacitated person is at stake.

What, we must ask, was the basis for the parent’s demands. What is it that was not in his best interest? It was not their fear that he would be forced to remain on the vent permanently which would cause him anxiety and confusion, because he was responding to treatment for his pneumonia and was weaned off the vent in a few weeks. He would, as presumably they were told, return to his normal base line. If this was the case, the reason for withdrawing the vent early would have been a decision to to end his life (kill him) notwithstanding his improving condition.

The level of proof required to justify terminal extubation as being in the patient’s best interest is the legal standard of clear and convincing evidence.

The trial court determined that there was no clear and convincing evidence to justify terminal extubation. The hospital argued that life preserving medical care must be provided and, no consent from a third party is required. Nor must any objection by a guardian or surrogate decision maker be honored.

The Supreme Court of Pennsylvania made clear that there is a public policy to preserve life in circumstances of a non-terminal conscious patient.

Moreover, the court noted that in this instance David never had the ability to appoint a surrogate decision-maker in situations where he did not suffer from an end-stage condition or permanent unconsciousness and his parents were precluded from making a decision to end his life unless there was clear and convincing evidence that he was in end stage disease or permanently unconscious.

Even in the situation of a conscious cognitively able patient we must appreciate that a request to withhold life sustaining treatment in a patient with a non terminal condition, still requires a showing of clear and convincing evidence that the patient has the capacity to make such a decision.

We should allow some time to pass, have a psychiatric consult; neurologic consult to evaluate any potential underlying injury or insult that might affect the decision-making capacity.

As a patient’s condition improves and the risk of death is diminished the greater the need for a more paternalistic plan of approach when the patient’s or surrogate's demand may result in unnecessary death.

Many patients with mental illness may have capacity to make medical decisions for themselves and many normal cognitively functioning patients may not have capacity. We should not refuse an autonomous decision by a patient, yet we cannot blindly accept a decision by a patient who could return to a reasonable quality of life if treated for a short time.

Physicians must be free to fully evaluate the patient without fear of liability for “refusing” the patient’s demands. As a patient’s condition improves and the risk of death is diminished the greater the need for a more paternalistic plan of approach when the patient’s demand may result in unnecessary death. In this instance the medical record should reflect that the physicians are not refusing the patient’s demands, but first, fully evaluating the patient’s condition before the demands can be accepted. Involvement of bioethics consults and ethics committees will help to protect both the patient from harm and physicians and hospital from claims of liability.

Clinical Bioethics: Betancourt v Trinitas - Appellate Court Decision

Bernard W Freedman, JD, MPH — Tue, 17 Aug 2010 16:00:16 -0800

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.”

Betancourt v Trinitas - Life, Not Policy

Bernard W Freedman, JD, MPH — Fri, 25 Jun 2010 07:44:26 -0800

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.

Red Flag Rules and the Practice of Medicine

Bernard W Freedman, JD, MPH — Tue, 08 Jun 2010 07:30:54 -0800

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

Bad Ad Program for Misleading Drug Ads

Bernard W Freedman, JD, MPH — Fri, 14 May 2010 10:13:09 -0800

The U.S. Food and Drug Administration has created a program to help recognize misleading prescription drug promotion and provide an easy way to report concerns.

The program will engage health care providers at medical conventions and partner medical societies to distribute educational materials.

Phases 2 and 3 will expand the FDA’s to update educational materials developed for Phase 1.

The FDA’s traditional monitors prescription drug promotion presentations created by drug companies themselves.

Health care professionals are encouraged to report a potential violation in drug promotion by sending an email to badad@fda.gov or calling 877-RX-DDMAC. Reports can be submitted anonymously.

It is unclear what motivational incentives the FDA can effectively enforce. By signing off on the promotions the FDA actually participates in the promotion of prescription drugs by allowing drug companies and their agents to claim ”FDA approval” as part of promoting the drug to the public and physicians.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm211611.htm

Mandated Insurance Coverage for Phase I and II Clinical Trials

Bernard W Freedman, JD, MPH — Thu, 29 Apr 2010 21:15:19 -0800

At present the Missouri State Senate is considering new legislation (SB 365), which means to provide health insurance coverage for Phase I and Phase II clinical trials for cancer treatment. The law in the state of Missouri presently limits mandated insurance coverage to Phase III and Phase IV clinical trials.

Aside from the fact that this bill makes no sense whatsoever, it highlights the ignorance of what Phase I or Phase II trials are intended to accomplish. SB 365 seeks to force insurers, non profit health services plans, or health maintenance organizations to treat Phase I and II trials as if they are treatment – beneficial to the patient – which they certainly are not. Since neither Phase I nor Phase II clinical trials are deemed treatment, or have any reasonable expectation of any real benefit to the patient, it makes no sense to compel payment for claims unrelated to actual health care treatment.

Phase I trials are used solely to determine levels of toxicity of the drug being investigated. Phase II trial try to determine if the drug being investigated has any effect on the underlying disease, in this instance, cancer. Prior law in Missouri did make some sense by requiring insurance coverage for phase III and phase IV clinical trials would be covered because of, at least, the opportunity of benefit the patient i.e. actual therapeutic treatment.

The bill then, in contradiction of the scheme of clinical trials, requires that “available clinical or preclinical data must provide a reasonable expectation that the treatment will be superior to the non-investigational alternatives.” This is outright stupidity because by the nature of phase I and phase II clinical trials there cannot be any clinical or preclinical data that provides any reasonable expectation that there is any treatment, actual therapeutic care, that will be gained. The bill seems to suggest that the patient will benefit from coverage for “routine patient care costs incurred for drugs…” The proposed legislation, however, defines “routine patient care cost” are the necessary costs needed to administer the drug under evaluation in the clinical trial, not actual care and treatment that will protect the patient. Accordingly, this proposed legislation is a sham, forcing insurers to pay for investigational drug research being performed by pharmaceutical companies, government, biotech companies, academia and privately run (outsourced) clinical trial programs.

All costs for Phase I and II trials should be born by the research investigators, including all necessary medical costs for the patient’s underlying condition as well as care during the clinical trial and thereafter to the degree that treatment is related to ill effects or adverse reaction to the drugs or medical devices being investigated.

This proposed legislation is unconstitutional by interfering in the right of freedom of contract because it requires payment for things outside the purview of the insurance contact for actual medical, therapeutic treatment.

Many states are considering, or have passed, similar legislation. For example in Arizona (SB 1213 2000) requires cost for patient care associated with clinical trials phase I through 4. Yet coverage is limited when no clearly superior non-investigational treatment exists. California has passed the same legislation limited to , “when no clearly superior non-investigational treatment exists.” The confusion here is that neither Phase I or Phase II trials are “treatment.”

Colorado (HB 09-1059-2009) requires a similar coverage, but only when the physician believes that the patient may benefit from the clinical trial and when the patient has a disabling progressive or life threatening condition.

Connecticut (SB 325-2001) mandates coverage, but only in Phase III clinical trials and only if they involve “therapeutic intervention.” This legislation makes sense because it is limited to instances of “therapeutic intervention.”

Similarly Delaware (SB 181-2001) mandates coverage only when the clinical trial provides “therapeutic intent and where the trial is not designed exclusively to test toxicity or disease pathophysiology. This would, therefore, exclude coverage of Phase I and Phase II trials.

Indiana (HB 1382-2009) is similar to the confusion of the Missouri bill because it requires cost to be paid for Phase 1 through phase IV cancer clinical trials – but only when there is no clearly superior non-investigational alternative care available, and when the clinical data shows that the care method used in the research study is likely to work as well as approved care. This condition may make sense in Phase III or IV trials but not feasible in Phase I or II trials.

North Carolina (SB 199-2001) has some interesting additions. Patients who are suffering from life threatening disease or chronic condition may designate a specialist who is capable of coordinating their health care needs and insurers do not have to pay for “investigative” clinical trials. Similarly Wisconsin (AB 617-2006) limits insurers’ responsibility for payments when trials are intended to improve the participants’ health outcome and not designed only to test toxicity or disease pathophysiology – thus eliminating mandated coverage in Phase I and II trials.

The level of misunderstanding (feigned or actual) of the purpose of Phase I and Phase II clinical trials will have to be dealt with by the Federal Court of Appeals and possibly the Supreme Court to provide constitutional clarity as well as uniformity throughout the various States.

In addition to the confusion is a significant problem of giving credence to recruiting efforts Phase I and II cancer patients by giving the impression that Phase I and II trials are therapeutic and “paid for by your insurance company.” Informed consent is especially important in Phase II and II trials. These laws summarized above should not tend to lessen the requirement of detailed and well documented informed consent.

Funding for physician discussion of end-of life decisions

Bernard W Freedman, JD, MPH — Wed, 28 Apr 2010 08:15:52 -0800

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.

Targeting Breast Cancer Patints

Bernard W Freedman, JD, MPH — Fri, 23 Apr 2010 10:41:20 -0800

U.S. Department of Health and Human Services (HHS) Secretary Kathleen Sebelius sent a letter to WellPoint urging them to immediately end their practice of dropping health insurance coverage for women with breast cancer, after Reuters reported that the company “has specifically targeted women with breast cancer for aggressive investigation with the intent to cancel their policies.”

New York will pass the Family Health Care Decisions Act

Bernard W Freedman, JD, MPH — 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 W Freedman, JD, MPH — 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