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

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

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

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

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

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

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

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

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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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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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