Rights and Wrongs: The Ethics of Patient Demand

The term consumerism is being used more and more in health care, and I use it myself on occasion, because it represents the sea change in the patient-provider relationship. However, I do not refer to patients themselves as "consumers"; we aren't talking about selling hamburgers or disclosure of credit card fees here (although sometimes I wonder if certain providers understand that). Besides, as has been discussed to death, there is little transparency in health care, whether the issue is what insurance really covers, co-pays for pharmaceutical products, the everlasting mystery of hospital costs — it's all a state secret, despite efforts to make more information available.

But three battles are taking place in health care that are as transparent as can be, and interestingly, they all involve pharmaceutical products: physician-assisted suicide; the "right to try," which allows terminally ill patients to use drugs not approved by the Food and Drug Administration; and parents' refusal to have their children inoculated against such diseases as measles, diphtheria, pertussis and tetanus.

Physician-Assisted Suicide

Physicians' writing prescriptions for or directly providing lethal doses of medications to terminally ill patients is hardly new; it has been done as a private matter for a long time. I remember interviewing a noted physician decades ago who told me that he had provided such drugs on occasion, but that his patients never used them; knowing that they had the option was comfort enough.

And then there was pathologist Jack Kevorkian, who in the 1990s managed to convince more than 100 terminally ill patients that sniffing lethal gases or injecting themselves with fatal doses of medication in the back of his van constituted a dignified death. Kevorkian also advocated using condemned prison inmates for radical biomedical experimentation, saying that they could always be resuscitated if it turned out they were innocent. As he wrote in 1959, "I propose that a prisoner condemned to death by due process of law be allowed to submit, by his own free choice, to medical experimentation under complete anesthesia (at the time appointed for administering the penalty) as a form of execution in lieu of conventional methods prescribed by law."

There's nothing like confusing clinical trials with executions.

But there has been progress in terms of what bioethicist William Nelson, Ph.D., termed "the quality of death" years ago. The advent of palliative care (still underused) and hospice (although it is not always provided with the patient's best interest in mind because of financial incentives) has eased a great deal of suffering and has probably reduced the number of private suicides abetted by physicians.

There also has been a sharp increase in the percentage of Americans who have executed advance directives stating their wishes if they are ill or injured and unable to speak for themselves. The data are not great — this is a subject of research that should be pursued — but studies show that approximately 70 percent of people older than 65 have executed such directives, and 30 to 35 percent of all Americans have done so.

However, these data are soft enough to stuff a doughnut. Often, wishes are expressed orally to friends and family without formal documents. And there are major gaps among ethnic groups: Older, more educated white people are far more likely to have advance directives than are other people, and African-Americans are quite unlikely to have them. (Given widespread suspicion of the health care system on the part of many Americans of color, I do not find this surprising; there are longstanding beliefs that African-Americans have been killed in order to harvest their organs for transplantation, and that they are used for unethical biomedical experimentation. The legacy of the Tuskegee atrocity is still with us.)

Some patients and advocacy groups, however, have fought for years for legalization of physician-assisted suicide, or PAS, and so far have succeeded in Montana (where a court order must be issued first), Oregon, Washington and Vermont. Other state legislatures are considering the issue. The advocates' cause was aided when a young California woman, Brittany Maynard, who was suffering from terminal brain cancer, moved to Oregon so she could legally receive lethal drugs from a physician. She took her own life on Nov. 1, 2014.

There was a heated debate earlier this year in the California legislature over a bill that would have legalized the practice. It stalled in the state Assembly after passage by the Senate, and will not be addressed again this session. But during the debate, the California Medical Association changed its position on the issue from opposition to neutrality.

There is another law on the books. The federal Patient Self-Determination Act, passed in 1990, requires most institutional health care providers and insurers to provide information about advance directives to patients and to ask if they have one or wish to execute one.

In addition, the Centers for Medicare & Medicaid Services announced in July that as of January 2016, it will reimburse physicians for discussions with patients as to their wishes for care at the end of their lives if they cannot speak for themselves. This was originally part of the Affordable Care Act, but after opponents protested that it would lead to "death panels" and put pressure on ill people to forgo lifesaving treatment, the provision was dropped.

Here we go again. Be prepared for Death Panels Redux. It is such an insult to our medical and nursing professionals that for a lousy $50 or so, they would try to convince their patients to drop dead instead of asking for effective care.

In the meantime, private decisions will continue to be made.

I grant you that my opinion and a transit card will get you a ride on the bus in Chicago, but for whatever it is worth, I oppose legalization of PAS. I support what I gently call "selective enforcement," which is simply that if a terminally ill, competent patient and a physician who knows the patient well make a deal, the authorities should just look the other way. It's been going on for years.

I have three reasons for my opposition.

First, I have done too much research on rogue practitioners to be naïve about the fact that although the incidents are rare, there are people who work in health care who choose to murder patients, and legalization of PAS is likely to increase their opportunities. Giving impunity to people who have access to lethal drugs is risky.

Second, although there do not appear to have been untoward incidents in Oregon, which has the longest track record with legal PAS in the United States, in other places — notably the Netherlands — many of the patients who have been, effectively, euthanized, did not request the procedure. In our aging society, with the likelihood that there could be 3 million people older than 100 by 2050, many of them with chronic illness or dementia, the temptation on the part of those who pay for health care to dispatch them could be overwhelming.

Third, some physicians may not wish to participate in PAS, and legalization could force someone who is the only doctor in town, or who is the patient's primary care physician, or is in a narrow network, to make a tough decision. The same holds true for pharmacists, who are even more likely to get caught in this bind. Either you have to betray your own beliefs, or your patient may feel that he or she has been betrayed.

I think it is best to keep this private. But I also think I am on the losing side of this issue. In time, PAS will be legalized in many states. And we will have to see what happens.

'Right to Try'

The movement to allow terminally ill patients to try medications not yet approved by the FDA (or perhaps not even submitted to the FDA) is more recent, but it is catching on. As I write this, at least 17 states have passed "right to try," or RTT, laws, and such legislation is pending in others.

This, too, is a dicey issue. The argument — one with which I am uncomfortable — is that the patients are dying anyway, so what the heck. My discomfort has to do with the fact that this could be another way to conduct radical experimentation à la Kevorkian, albeit with patient consent (or at least one could hope so). In both cases, so the argument goes, the inmates and the patients are, in all probability, not going to live for much longer, so maybe some good can come out of their deaths.

The problem, of course, is whether approval given by desperate, dying people meets the basic standard of informed consent. And it is made more complicated by the fact that it is patients who are pushing for this right.

According to David Farber in a Health Affairs blog on May 22, most RTT laws require that the patient be terminally ill, that a physician recommend use of the treatment (although how a physician is supposed to know if it might work is a good question), that the patient provide informed consent (also an iffy matter), and that "the treatment has completed a Phase I clinical safety/dose limitation trial." Most RTT laws also provide liability protection for physicians and pharmaceutical manufacturers in the event of harm to the patient.

But it is fair to ask if RTT is even needed. Farber points out that the FDA already has an "expanded access" program through which patients who have serious or life-threatening conditions for which no currently approved treatment exists can participate in a clinical trial from which they might otherwise be excluded, as long as the benefits are likely to outweigh the risks and their participation will not interfere with the clinical trial or its outcomes. Again, how anyone is supposed to know if that is the case is an open question.

It has been suggested that this is a ploy by Big Pharma to put pressure on the FDA to approve this or that drug or to shortcut the approval process. Interestingly, that does not appear to be the case. Indeed, Sascha Haverfield, vice president for scientific and regulatory affairs, Pharmaceutical Research and Manufacturers of America, has been quoted as saying, "Legislation at the state level, however well-intentioned, is unlikely to add any meaningful new approaches that can optimize the federal expanded-access process overseen by the FDA. We have serious concerns with any approach to make investigational medicines available that seeks to bypass the oversight of the FDA and clinical trial process, which is not in the interest of patients and public health."

This is not surprising. These are deep waters, and allowing patients, no matter how ill they are, to try unapproved medications is a lawsuit waiting to happen.

There are also problems with the "they're dying, anyway" argument. In 1987, a pregnant woman, Angela Carder, was diagnosed with cancer, and despite her efforts to stay alive long enough to give birth, it became obvious that with her fetus being only 26 weeks along, she was not going to make it. A complex series of court proceedings ensued, and Carder was subjected to an involuntary cesarean section, despite her fervent objections. The fetus did not survive; neither did Carder. The justification? "She's going to die, anyway."

Last time I looked, dying people had the right of self-determination, like anybody else.

Personally — and remember that a transit card and my opinion will get you to downtown Chicago — I think that if terminally ill patients want to try an investigational drug, and as long as there is something resembling informed consent and the drug has at least been tested to the point that it is known that it doesn't cause horrible side effects or early death, that is their choice. But I don't think they should be forced to pay for use of the drug, and I feel strongly that they need to be fully informed as to what side effects have been detected. And I most certainly believe that this should not devolve into some kind of unmonitored cowboy clinical trial.

People should be able to have as comfortable a death as is possible. Death is, of course, never comfortable, especially for us Americans who think we are immortal. But there is a middle road between letting people die in agony, as so many did when providers were afraid to prescribe narcotics even to people who were days away from death, and using dying patients as lab rats.

I grew up in a hospital. The gentle man who tended the lab rats cared about them. We should have at least the same compassion for patients who are dying.

Refusal to Inoculate

The state of California (why does so much of this happen in California? No Left Coast jokes, please) just passed the toughest law in the country requiring inoculation of children against infectious disease, following an outbreak of measles at a Disney theme park that afflicted 147 people. Fortunately, no one died, although measles can be fatal. The law does not recognize "personal belief exemptions" from childhood vaccinations. The only other state with such a law is West Virginia. The new law exempts only children with allergies and immune system problems that have been documented by a physician. The statute takes effect next year.

Those opposed to the law have announced that they will sue.

A young man recently died of bubonic plague in Colorado, which is an outlier situation because, unfortunately, we have no vaccination for plague. But it was a warning. Infectious disease remains a clear and present danger in our country.

Certain celebrities have announced that they are convinced that inoculation against common childhood diseases — diphtheria, pertussis, tetanus, mumps, rubella, polio and measles — causes autism. This misbelief is based on a discredited study published in 1998 in The Lancet by a physician named Andrew Wakefield, whose research was, to put it nicely, flawed, and who was eventually stripped of his medical license.

Nonetheless, the belief that vaccination causes autism has persisted, even though there is not a shred of clinical evidence that a relationship exists between the two.

The issue here, of course, is personal choice vs. public health. I have no doubt that parents who refuse to vaccinate their children are operating on the basis of two passionate beliefs: that inoculation could harm their children, and that it is their right to choose. Indeed, the major opposition group in the Golden State has titled itself the California Coalition for Vaccine Choice.

And if we were talking about non-communicable disease — asthma or arthritis — there would be no problem. If you don't want to protect your children against disease, that is your choice, although, frankly, I don't understand why a parent would choose to do that. So, if you want to smoke cigarettes in a home with an asthmatic child, you have the right to do so.

But we are talking about infectious disease. And that is different. The Disneyland measles outbreak can be traced to one factor, and one factor only: unvaccinated people. Why were they unvaccinated? Who knows? I am sure that some of those affected had not received inoculation because they or their parents thought it could be harmful. Some were undoubtedly visitors from other countries where vaccination is not as easily available as it is here. Some could have been unaware of the necessity — and yes, I believe it is a necessity — to protect yourself and your family from serious illness. And some of them could have been children who were too young for inoculation, who constitute the group at greatest risk from those who are carriers of infectious disease.

We cannot control what foreign visitors do. But we can require that those living in this country not put other people's lives at risk. This is a public health issue, and the public's health trumps personal beliefs, especially when they are misguided.

I saw what poliomyelitis did to children of my generation. I have had measles, rubella, chicken pox, shingles and other conditions because vaccines were not yet available. When I developed symptoms of rubella — "German measles" — which can cause serious birth defects, at work, a co-worker had to scrub down my office to prevent a fellow employee who might have been pregnant from suffering the consequences. I was sent home immediately.

There is another risk, and it is a big one: bioterrorism. The bad guys are perfectly aware that unvaccinated people are sitting ducks.

If you want to put yourself or your kids at risk, be my guest. It's a free country. But you have no right to put anyone else at risk. Home-school your kids. No day care. No visits to the park. No trips to Disney sites. No restaurants. Keep them locked up in your home. The California Coalition for Vaccine Choice posted a statement: NO SHOT. NO DAY CARE. NO SCHOOL. EVERY CHILD. EVERY VACCINE.

You betcha.

The Slippery Slope

Obviously, the familiar ethics concept of the "slippery slope" comes into play here. For those of you who have not encountered this notion, it is simply that an idea or a practice or a product or service starts out narrowly defined, and then starts expanding. I like to use Botox as an example: What began as a cosmetic enhancement is now being marketed for treatment of migraines and other conditions. "Off-label" prescribing of pharmaceuticals has become a national sport; although there have been fines and penalties, the idea is just too profitable to be stopped — get the drug approved for some use, then expand its applications, and eventually the FDA will cave. Organ transplantation began as a very disciplined enterprise; now there are programs that would transplant a petunia into a gopher if they thought they could get away with it. And it's very lucrative, I might add.

Similarly, those who oppose PAS and RTT have a point: Maybe it starts with desperately or terminally ill people simply wanting control over the end of their lives, but it could easily slip down the slope to involuntary euthanasia or utterly unsafe informal drug trials. The dangers of not vaccinating children and then sending them to the community swimming pool are obvious; the dangers of possible exploitation of sick and dying people are more subtle, but they are there.

Somebody needs to be watching the store here, and I'm not sure that anyone is doing so, or will do so in the future.

A Few Ethics Principles

Which brings us to a few ethics principles that might be useful in this new era of controversial patient demand.

As has already been adopted widely in the case of abortion and contraception, no provider (including physicians, nurses, pharmacists and other health care professionals) should be required to participate in an act that violates his or her personal beliefs. Health care professionals have rights, too. However, legitimate patient demand needs to be accommodated whenever possible.

In the case of physician-assisted suicide and "right-to-try" situations, true informed consent is essential. The patient must know what he or she is getting into, and what the consequences are likely to be.

Patients should be fully aware that palliative care and hospice alternatives are available, and should have access to them, regardless of financial constraints. That includes their being aware of the possibility that to reduce pain and suffering, the patient's life may be shortened.

Unapproved medications should not be used if they are likely to make the patient's condition worse or if they could cause greater pain or other suffering.

All acts involving "death with dignity" — that is, physician-assisted suicide or similar situations — must be monitored and reviewed, so that rogue practitioners cannot use the impunity that these laws grant to commit murder.

Any person who refuses to be inoculated against infectious disease, or who refuses to have family members inoculated, can, along with those who have not been vaccinated, be denied entry to any public place where other people are present.

Public health authorities have the right, historically, to quarantine anyone who presents a threat to public health. Let them use it when necessary.

No one — not provider, nor patient, nor members of the general public — should have impunity when they have caused harm to others, whether it is killing patients or infecting others (who also should have been vaccinated).

Clinicians and patients should be able to make private agreements as to the circumstances of the patient's death without interference from advocates for this or that cause.

Everyone should have a valid advance directive.

This is tough stuff. I know that because of personal experiences my readers will never have to know about. But these issues must be discussed. We need to stop tormenting those who are dying. We need to have better oversight of pharmaceutical experimentation. We need to stop thinking that death is optional. And most importantly, we need to talk with each other about these issues without rigid ideological positions, trying to impose our beliefs on others, or just screaming at each other because we think our positions are correct. There are no rights or wrongs here; there is, rather, a need for compassion and compromise.

Emily Friedman is an independent writer, speaker and health policy and ethics analyst based in Chicago. She is also a regular contributor to H&HN Daily and a member of Speakers Express.