Bioethics & Pharmaceutical Prices

Just last week a man walked into my office holding a vile of insulin.  He told me its cost and how much it has increased over time.  He expressed genuine fear that people would not be able to afford it much longer and that they would eventually die because of it.

Later that day, I noticed that the Washington Post and other media outlets were running stories on the dramatic rise of cost of EpiPens—up 450% since 2004.  Given that this product saves lives, the spike in cost is quite concerning.  When it came to light that the CEO of Mylan, producer of EpiPens, is the daughter of a United States Senator, the indignation increased.  Just today, in an apparent attempt to save face, it is reported that Mylan will produce a generic version of the EpiPen that will cost half of the brand name.  (Please also see the blog of Mark McQuain on the EpiPen.)

Last week JAMA published an article entitled, “The High Cost of Prescription Drugs in the United States.”  It notes, “The most important factor that allows manufacturers to set high drug prices for brand-name drugs is market exclusivity…” If the playing field is cleared of all competition, there are few, if any, market forces that might cause prices to stabilize.  Especially disturbing was the discussion of “pay to delay”– when drug manufacturers pay the makers of potential generics to delay their production.

I have met those who argue strongly that the free market must be respected, even in the face of skyrocketing prices.  They say that pharmaceutical companies have the right to charge whatever the market will bear because they’ve done the hard work of research and development.  Undoubtedly, they argue, the companies will use the profits to develop other life-saving drugs.  Put simply, they conclude that it is the result of the law of supply and demand.  But if the pharmaceutical company has a monopoly endorsed by the federal government, is it really a free market?

It seems that by applying the principle of justice, bioethics may have much to say about the rising cost of prescription drugs.  In an age where incredible things are happening with the creation of life-saving drugs, it is important they reach as many people as humanly possible.

Christians and Physician Assisted Suicide

In my experience working with terminally ill patients over the past seven years, I have often seen people of the Christian faith go all out in the ICU, wanting “everything done” for a terminally ill loved one. In these circumstances, when I speak with family members of the patient, they tell me they will continue to pray for a miracle to happen. As a person of faith, I respect their faith and their right to exercise it. When appropriate, I gently remind them that ultimately we all die and that, in the case the miracle does not happen, it is good to have an end-of-life plan in place.

This experience came to mind when I read a recent article in www.time.com by Corinne Johns-Treat, a cancer patient who has decided that she wants “death with dignity.” The article stands out because she explains how she came to that decision in the context of her faith: “…[T]he more I learned about the safeguards and autonomy in the law, and the more I prayed about it, having seen people suffer so much at the very end of their lives, I came to believe in that it fit into my faith. I found comfort in this law” (California’s ‘End of Life Option Act’).

As I read her thoughtful article, several familiar themes arose: autonomy, personal suffering, and the painful experiences of others. These, of course, are used by others defending PAS who do not necessarily have a particular faith commitment. To place her decision within the framework of her Christian faith, Johns-Treat adds this thought: “If God grants us the intelligence to enable doctors to offer treatments that prolong life—that have prolonged my life—wouldn’t that same logic apply to those of us nearing the end of our life? When science can’t offer life-sustaining treatments anymore, then the role of medicine should be to relieve suffering.”

I don’t know anyone in the medical field who would disagree with the goal of “relieving suffering.” The question is how to define it. Cannot palliative care offer more to the dying patient than PAS? My work in hospice showed me that death does not need to be anguish for patient and family alike during the final hours of life. Palliative care physicians and their teams do tremendous work every day to relieve the terminally ill of their suffering. As the field of palliative care continues to deepen and grow, and as people become more aware of their mortality, I hope that PAS does not become the default method of “relieving suffering.”

Christians – and members of other faith groups – will undoubtedly continue to wrestle with these issues in the coming days. This is important because they are indeed matters of life and death.

Is assisted suicide ethically permissible if it is rare?

A recent JAMA article (subscription needed) shares the findings of a study which considers the “Attitudes and Practices of Euthanasia and Physician-Assisted Suicide in the United States, Canada, and Europe.”  As California has become the most recent state to add an “assisted death” law to the books, it is important to consider how the practices of euthanasia and physician-assisted suicide are viewed in places that have had them in place for a while.  Might they give us a hint of where we are headed?

The article highlights many important issues related to PAS and euthanasia.  It concludes,  “Euthanasia and physician-assisted suicide are increasingly being legalized, remain relatively rare, and primarily involve patients with cancer.  Existing data do not indicate widespread abuse of these practices.”  Implied in that sentence, then developed later in the article, is that the authors do not believe that there is a “slippery slope:”  “In the United States, the concern that minorities, the disabled, the poor, or other socioeconomically marginalized groups might be pressured to accept PAS does not seem to be borne out.  The demographic profile of patients in the United States who have received these interventions is white, well-educated, and well-insured.”  While that might be heartening at some level to those who fear for the marginalized of society, it does not remove all concerns, because the practice is not yet widespread in the United States.  The slope may be longer and less steep than first imagined, but it still appears to be a slope.

The JAMA study is helpful, but it does not address the ethical issues associated with this controversial issue.  One wonders if PAS is ethically permissible because it is rarely used?  Or, if it would somehow be less permissible if it were used more?  As more states move to enact PAS, I can easily envision proponents citing this article saying, “See, it’s not as bad as people say!”  True as that might be, it is not a substantial ethical argument.  It sounds like a modified version of an argument that many of us used with our parents when we were teenagers:  “It’s ok, Mom & Dad, everyone is doing it!”

Interestingly, JAMA notes that studies from Washington state and Oregon show that “[P]ain is not the main motivation for PAS.  Typically, less than 33% of patients experience inadequate pain control. The dominant motives are loss of autonomy and dignity and being less able to enjoy life’s activities.”  With that being the case, one might suspect that the patient requesting physician-assistance would be asked to undergo a psychiatric evaluation.  But, “[I]n Oregon, less that 5% of patients received a psychiatric evaluation and in Washington state only 4% were referred for psychiatric evaluations.”  Further research is needed here.

At a recent chaplain’s conference, I spoke with a chaplain from a large healthcare organization in California.  He told me that his organization was working on policies related to California’s newly implemented “End of Life Option Act.”  When I remarked that it sounded like a challenging endeavor, the chaplain repeated what many PAS advocates have said, “Dying patients seem to like having control over the end of their lives, even if they only have the lethal dose of drugs available to them, but do not use them.”

As the pressure mounts across the nation to pass PAS laws, we would do well to reassess these arguments and to develop a more thorough approach to define what we as a society want to affirm at the end of life.

On the “Moral Era” of Medicine

A colleague shared a recent JAMA article titled “Era 3 for Medicine and Health Care.” The author, Dr. Don Berwick, quickly surveys Era 1 — the “era of professional dominance”– and Era 2 — the “era of accountability and market theory”– before introducing what he hopes to see in “Era 3,” the “moral era.”

Berwick identifies nine changes that need to take place in order to accommodate this new era which has seen the implementation of ACA, the extensive use of electronic medical records, and the consolidation of hospitals and health plans. Several of the suggested changes are already taking place in health care systems across the country. Others are a bit more idealistic. I would like to use this space to mention two of the more idealistic changes.

Change number 8 is “hear the voices of the people served,” a noble goal indeed. While many health care organizations have moved in the direction of ‘patient-centered care,’ fewer embrace “paying special attention to the needs of the poor, the disadvantaged, and the marginalized, and firmly defending healthcare as a universal human right.” Seeing each patient as a human being, possessing great worth and dignity, is fundamental to all areas of bioethics, from the research lab to the bed of the dying patient. Humans need to be treated with humanity.

Change number 9 is even more idealistic: “Reject greed.” Berwick writes:

“Health care has slipped into tolerance of greed and it has to stop, through volunteerism when possible, through strong regulation when not. Rapacious pharmaceutical pricing, hospitals’ exploiting market leverage to increase prices, profiteering physicians, and billing processes that deteriorate into games with consultants coaching on how to squeeze out more profit all hurt patients and impair trust.”

Idealistic, right? But we know that one devastating medical emergency can bankrupt an insured middle class family and that many others are finding it impossible to make ends meet while undergoing expensive medical treatment. Bioethics should continue to address the staggering financial impact that medicine has on our society. As Berwick suggests, blindly ignoring these factors will lead to even greater regulation.

Bioethics has much to say if “Era 3” is truly to be the “moral era.”

Organ Harvesting in China

On June 13, 2016 the House of Representatives passed HR 343, “Expressing concern regarding persistent and credible reports of systematic, state-sanctioned organ harvesting from non-consenting prisoners of conscience in the People’s Republic of China, including from large numbers of Falun Gong practitioners and members of other religious and ethnic minority groups.” )  In part, the bill “calls on the United States Department of State to conduct a more detailed analysis on state-sanctioned organ harvesting from non-consenting prisoners of conscience in the annual Human Rights Report.”  This is a welcome response to a horrific practice.

Newsweek  reports that according to The Falun Dafa Association, “[I]n China patients aren’t waiting for organs. Rather, organs are waiting for patients.”    This is because executed prisoners provide a constant supply of organs.  The international community must continue to voice its strong disapproval of this practice.  We look forward to the June 22nd report of David Kilgour, former Canadian Secretary of State, investigative journalist Ethan Gutmann, and Canadian human rights attorney David Matas on China’s organ transplantation industry.  It is to their great credit that they are shining a bright light on this troubling issue.

Organ donation is a scientific marvel and a great blessing to those who have received life-saving organs.  Executing  prisoners of conscience and harvesting their organs is beyond the pale of ethical conduct.  It defies human dignity and scandalizes the international community.  It needs to stop.

An Olympic-Sized Decision

Every four years, the nations of the world come together to celebrate sport and sportsmanship in the Olympic games.  The beauty and pageantry of the Olympics make it a quadrennial spectacle that is viewed by billions of people around the world.  Little-known sports gain international attention for a few days and unknown athletes burst into our living rooms with demonstrations of strength, speed, and endurance.  It’s all very exciting.  Enter controversy.

Olympic controversy has been abundant over the years.  Cold War tensions, doping scandals, unethical judging of events like figure skating and gymnastics are just a few of the scandals that have surrounded the Olympics over the years.  Host cities and countries have had their share of controversy also.  Sometimes Olympic cities seem ill prepared to host the games or the people from the host city wonder why the millions of dollars that are being spent on stadiums and hotels are not spent on education and health care.

The latest Olympic controversy centers on the Zika virus.  As word of some of the devastating effects of the virus rose, people began to ask if it is safe for 500,000 people from all over the world to come to Rio de Janeiro.  What if an Olympian (or any tourist) contracts the virus, then takes it back to his or her respective country?  Would there be disastrous implications?  Is this a risk that the international community should be willing to take?

Up to this point, the International Olympic Committee and the World Health Organization have resisted any attempts to postpone the Rio games.  However, bioethicist Arthur Caplan and a group of 150 experts have published a letter calling on WHO to act:  “WHO must revisit the question of Zika and postponing and/or moving the Games. We recommend that WHO convene an independent group to advise it and the IOC in a transparent, evidence-based process in which science, public health, and the spirit of sport come first. Given the public health and ethical consequences, not doing so is irresponsible.”

Now The Washington Post is reporting that Dr. Margaret Chan, WHO Director-General, has asked “members of the Zika Emergency Committee to examine the risks of holding the Olympic Summer Games as currently scheduled.”  Given the gravity of the situation, these are reasonable steps.  Caution must be exercised and the risks must be accurately assessed.  The potential cost to human life is too great.

Brain Cancer Awareness Month

Watching “60 Minutes” last week reminded me of why I pursued a degree in bioethics. The segment was on Duke University’s experimental treatment of glioblastoma patients and its surprising success treating this deadly cancer. There is a cautious optimism associated with this new treatment, which was granted “breakthrough status” by the FDA earlier this month.

Immediately I was thrown back to 2010 when my wife’s nephew Michael was diagnosed with a grade IV glioblastoma. I didn’t know much about it at the time, but it didn’t take long to discover how deadly it was. He went through the typical regimen of treatment—chemo, radiation, and surgery. His life was extended about a year and a half. He was diagnosed at age 16; he died just weeks after his 18th birthday.

Ethics became important to me because I saw firsthand how Michael and his parents were treated during his final hospital stay. Of course, there was a lot of compassion and concern for him as a young man with a terminal disease. However, even though the medical staff knew the prognosis and the likely disease trajectory, they didn’t do a good job of communicating things. At the very end, when the cancer mercilessly returned, some staff members placed a lot of pressure on his parents to sign EOL orders. Because they had thought the treatment had cured him, all of this was a shock to them. They were unprepared to have a DNR order placed. Eventually the point was moot. The tumor continued growing, his brain herniated, and he died.

During those painful last few weeks of his life, one of his nurses told us that some of the staff had considered calling for an ethics consult, but didn’t. EOL treatment is messy and complicated. Looking back at the time, it seems clear that ethics should have been involved to do its work—gather information, hear from medical staff and family, and make recommendations based on the patient’s desires.

Although I am very happy to see that the Duke trial has met with some success, I wish it had come a few years earlier. May is “Brain Tumor Awareness Month”. Let’s remember those who struggle with brain cancer and those who are seeking to find more effective treatments for this horrible disease. And for those who are concerned with ethics, let us make sure to hear the voices of those who can be easily overlooked.

A brief thought on rising suicide rates

A recent article in The Washington Post describes a very disturbing trend: “The U.S. suicide rate has increased sharply since the turn of the century, led by an even greater rise among middle-aged white people, particularly, women, according to federal data released Friday [April 22]” The article offers some suggestions as to why things have been so grim: last decade’s severe recession, drug addiction, social isolation, and the rise of the Internet and social media are among some of the possible explanations. Beyond this, the authors suggest, “economic distress—and dashed hopes generally—may underpin some of the increase, particularly for middle-aged white people.” These explanations are all plausible.

I am wondering, however, if something is missing from this analysis. Economic distress is not the only relevant factor in the United States from the past 15 years. We have also witnessed an increase in the presence of “assisted death” laws.  Procon.org states that four states have legalized physician-assisted death via legislation (California [2015], Washington [2008], Oregon [1994], and Vermont [2013]) and  in one state it has been permitted through court ruling (Montana, 2009).  Might it be that these laws and the public debate that accompanies them have changed people’s attitudes towards suicide? There is a certain kind of logic here. If death with dignity is an ultimate good, why is it limited only to those who are terminally ill?  If I have suffered an irreversible personal loss – my job, my wealth, or my family – why can’t I logically conclude that enough is enough and decide to end it all?

I am not suggesting that the physician assisted death laws are the cause of the higher suicide rate. I am simply wondering about their overall impact on our cultural thinking on death and dying. Although The Washington Post article is accompanied by helpful information from the American Foundation for Suicide Prevention, and many compassionate people and organizations are committed to providing help to those in need, it might be that in the current cultural climate, the goal of suicide prevention has been made more difficult.

A day at a bioethics conference

In my life as hospital chaplain, I have observed that bioethics often entails conflict resolution—usually around end-of-life issues. In these situations, the ethics consultant is called upon to consider difficult treatment possibilities and related factors (emotional, spiritual, personal, etc), and then to make recommendations to the medical team. But I have come to learn that the field of bioethics is much broader than conflict resolution regarding end of life treatment.

Last week, I had the opportunity to attend the Florida Bioethics Network’s annual conference in Miami. I’ve attended this conference several times in the past and I’m never quite sure how to assess it. This year my bottom line is this: the conference underscores the great diversity within the field of bioethics. There were presentations on bioethics and global climate change, physician orders for life-sustaining treatment (aka POLST), developing functioning ethics committees, setting healthcare priorities, and medical futility. This, I thought, was a fairly wide-range of topics for a one-day gathering. Even so, the list of topics included in the field of bioethics could go on and on.

The diversity of topics within bioethics has a much greater impact than broadening its appeal. It reflects the interconnectedness of life. Bioethics is not limited to the decisions that are made in the ICU or the emergency room; it incorporates decisions that are made in the kitchen, in the grocery store, in the cafeteria line, as well as in the halls of government and in corporate executive suites. We serve our community well when we engage each other about these things and strive for the common good. Easier said than done, of course, but important nonetheless.

The NFL & Research Ethics

It’s not every day that research ethics makes it way to the front pages of the newspapers. Usually those issues are addressed in other, less prominent venues. But last week’s New York Times article by Alan Schwarz, Walt Bogdanich, and Jacqueline Williams, “N.F.L.’s Flawed Concussion Research and Ties to the Tobacco Industry,” continued the controversial concussion discussion by reporting that the multi-billion dollar league omitted “more than 100 diagnosed concussions . . . including some severe injuries to stars like quarterbacks Steve Young and Troy Aikman.” One critic formerly associated with the league is quoted as saying: “You’re not doing science here; you are putting forth some idea that you already have.” The N.F.L. concussion issue was brought to public attention through PBS’ Frontline  and more recently through the movie, Concussion.

The Times article notes the disagreement between what the league says now (“clubs were not required to submit their data and not every club did”) and what the league said at the time of its earlier studies: “It was understood that any player with a recognized symptom of head injury, no matter how minor, should be included in the study.” It calls into question what the league knew, when it knew it, and how that impacted the well-being of its players. Just a few weeks ago, the New York Times also published “The N.F.L.’s Tragic C.T.E. Roll Call,” a list of the some of the most notable cases of deceased players who were found to have C.T. E.

As a lifelong N.F.L. fan, I hope that league would do its part to ensure the safety of its players, whether symptoms occur during or after their playing days. As someone interested in bioethics in general, I hope that researchers would continue to use the best practices available to ensure that their data collection and results are unbiased. This is our responsibility to future generations.