This American Life and Stigma

by Michelle Meyer, Bioethics Program Faculty

UPDATE: This American Life has made a clarification. Please see Prof. Meyer’s latest blog post for more.

Let me begin by saying how much I absolutely adore This American Life (TAL). I listen to it religiously. I particularly had been looking forward to the most recent pocast episode of TAL: Dr. Gilmer and Mr. Hyde. As the episode’s blurb teases, “Dr. Gilmer and Mr. Hyde” concerns a doctor — Benjamin Gilmer — who takes over the rural South Carolina practice of Vince Gilmer (no relation). Vince is no longer available to see patients because he is serving a prison sentence for killing his father. As Benjamin gets to know Vince’s — and now his — patients, he forms a picture of Vince that’s at odds with his status as a convicted murderer. How could this doctor who was so devoted to his patients have so brutally murdered his own father?

This episode is right up my alley. True crime? Check. Forensic psychology? Check. The intersection of law and medicine? Yes, please. So when I awoke yesterday morning at 5 am and couldn’t go back to sleep, I eagerly cued up the podcast. The episode recounts, in TAL’s  typically-riveting fashion, the story of Benjamin’s search for the truth behind Vince’s murder of his father. I enjoyed every minute of the episode until the last five minutes or so, when I became troubled by one critical omission.

Spoilers  follow after the jump; listen to the episode first.

Hopefully, you’ve listened to the episode. You should; it’s good. But if not, here’s the gist, based on my memory of listening to the episode casually in the wee hours of the morning (read: some details may well be off).

The day in 2004 that he killed his 60-year-old father, Dalton, 41-year-old Vince picked him up at a psychiatric hospital to transport him to a nursing home. It’s not clear what his father suffered from, but whatever it was, he was dependent on a walker or wheelchair, required help with basic daily functions like dressing, and was on antipsychotic medications. Vince would later say that before dropping him off at the nursing home, he had promised his father that they would go kayaking at a favorite lake several hours away, and he had brought a kayak in the truck for that purpose. But his father had sexually abused his sister and him from the ages of 6 and 3, respectively. (The TAL reporter says that it’s the most horrific case of abuse she’s ever heard. Vince’s sister would later confirm the abuse, although she disappeared before the trial and hasn’t been seen or heard from since.) And somewhere en route to the lake, his father had made an inappropriate sexual comment or grope, and a compelling voice in his head told him to kill his father. He used a piece of rope to strangle him, tugging harder and harder until the man stopped struggling. He then moved the body to the bed of the pick up and drove around for hours trying to decide what to do with the body. Eventually, he took it to Virginia, where he used a small saw to to amputate the tips of all ten of his father’s fingers before dumping the body, to prevent it being identified. He then drove home. The next day, he went to work, where he told everyone that he had taken his father home, but that Dalton had wandered off and he had filed a police report. He acted perfectly normally the rest of that week, seeing patients and socializing with colleagues.

Until the police called on him. The body had been quickly discovered (still warm, in fact). And it had been quickly identified (Dalton’s shirt was stamped with a name tag, “D. Gilmer,” that Vince himself had arranged for). And police, not surprisingly, quickly decided that Vince was their guy. Vince told police that he had brought his father home to live with him, and that his father had gone outside to play frisbee with the dog before wandering off, something police knew couldn’t be true. Police say Vince wasn’t scared or agitated. Instead, he threatened to have the detective’s badge. Police also learned that he had a one-way ticket to Alaska scheduled for around the time of the killing. And he had stopped paying his father’s bills at the psychiatric hospital, and owed over $200,000. Before police could get an arrest warrant, Vince fled.

When police caught up to him, he finally confessed. Despite mounting a defense that hinged on severe cognitive disability, he insisted on representing himself at trial, where his behavior, according to court transcripts and observers, was a model of disordered thinking (his court-appointed attorney described it as akin to “watching someone try to commit suicide with a butter knife”). His defense centered on serotonin depletion. He had been on an SSRI to increase his serotonin, after struggling with anxiety for years, but had abruptly stopped taking it a day or two before the murder, rather than tapering it off as he surely knew he was supposed to do. As some do, he reacted very badly, he says, becoming extremely irritable, hearing compelling voices, and generally feeling “mentally retarded.” In the courtroom and, at least occasionally, in prison as he awaited trial, Vince displayed odd grimaces and shaking. He repeatedly asked prison officials for 80 mg of Celexa, uncrushed.

But when prison officials videotaped him in the prison courtyard, they noticed that his twitches and shaking seemed to conveniently come when prosecutors were in sight and go when they were not. And the rest of Vince’s story was fishy, too. He claimed that the killing wasn’t premeditated, but the plan to go kayaking made little sense given Vince’s father’s immobility, the fact that he had not brought a walker with him in the truck, and the fact that it was getting dark. And Vince had come to pick up his father prepared with both the rope and the saw (sometimes referred to in the episode as pruning shears). The jury took an hour to conclude that he had been faking his symptoms and found him guilty of 1st degree murder. The judge sentenced him to life in prison without the possibility of parole.

Benjamin can’t accept the idea that the kindly family doctor he’s come to know through their shared patients suddenly turned into a premeditate murderer of his own father. He begins to investigate, and variously pursues both Vince’s own hypothesis, serotonin depletion, as well as personality change due to a traumatic brain injury Vince suffered about a year before the murder. But in the end, Benjamin, on a hunch, wonders if Vince — and, for that matter his father — might have been suffering from a rare genetic disease, Huntington’s. Once called Huntington’s Chorea (for the dance-like movements most sufferers exhibit), Huntington’s Disease (HD) is perhaps best known as having killed Woody Guthrie. As the TAL reporter says, HD is “a horrible condition, one of the worst, like a cruel trifecta of Alzheimer’s, Parkinson’s, and Lou Gehrig’s Disease rolled into one.” Its progressively severe physical, emotional and cognitive symptoms invariably lead to death, generally within about 20 years. HD is caused by an excessively long trinucleotide repeat (CAG, in particular) on the huntingin gene, on the short arm of chromosome 4. Genes code for proteins, and excessively long strings of trinucleotides code for excessive amount of protein, where it wreaks havok in the brain. Anyone who has 40 or more CAG repeats will get HD within a normal lifespan, and each of their children has a 50% chance of inheriting the allele (which may or may not either contracted or expanded below or above the parent’s CAG repeat length).

By this point in his investigation, Vince has been moved to a psychiatric ward within the Virginia prison system after he threatened to commit suicide, and Benjamin and the TAL reporter suggest that give him Vince the genetic test for HD, which they do via a simple blood draw, apparently after a psychiatrist counsels him. It comes back positive: one copy of Vince’s huntingtin gene has 43 CAG repeats. (One oddity is that it appears that the diagnosis was emailed to Benjamin, who then, some weeks, later, broke the news to Vince by phone, portions of which were recorded and included in the TAL episode. HIPAA, anyone? And of course, as TAL notes, Vince’s diagnosis suddenly means that his (missing) sister is at 50% risk of having HD, and her kids are at 25% risk. One wonders what they think of that information being public.)

In terms of the mystery of why Vince killed his father, the episode pretty much ends there. HD can lead, among other things, to serotonin depletion, so it’s possible that, in a way, Vince’s theory of his own crime was right all along. Indeed, following the diagnosis, his psychiatrist has prescribed the exact 80 mg of Celexa that he had been requesting for 9 years, and he reports feeling less anxious. The final few minutes of the episode turns to the injustices done to Vince, and how they might be redressed. Benjamin and the TAL producer rightly note that at the very least Vince, who exhibited symptoms of HD at the time of the killing, should never have been allowed to represent himself. As for releasing him from prison, University of Virginia School of Law’s Richard Bonnie suggested that instead of making that argument in court, they pursue compassionate release.

I’ll leave others to comment on the criminal law aspects of the case. I want to talk about something else. The implication of the episode (and its unfortunate title) seems to be that Vince Gilmer killed his father because he has HD. TAL speculates, not unreasonably, that Vince likely inherited HD from his father. And so the epsiode also implies that Dalton Gilmer may have brutally abused his children because he, too, had HD. Either or both of those things may well be true. But although the occasional incidents involving people with HD who kill themselves or others make for splashy news and riveting human interest stories, the fact is that the vast majority of people with HD are not dangerous to themselves or others. Although psychosis is one of many possible manifestations of HD, most don’t experience that particular symptom and, again, of those who do, very, very few end up harming themselves or others.

People with HD are instead much more likely to be the victims of violence. They were burned at the stake as witches in Salem and sent to the gas chambers during the Holocaust, for instance. Less dramatically, they are routinely turned away from public accommodations or arrested because their chorea is mistaken for drunkenness. Many who are at risk for HD choose not to be tested, not only because they don’t want to know, but also, in many cases, because they fear the consequences of an HD diagnosis for their employment and insurance status (GINA notwithstanding), on top of the risk that others will respond to them with irrational fears and prejudices.

Thanks to highly popular portrayals of HD like that in “Dr. Gilmer and Mr. Hyde,” the public has associations with HD that the already-horrible reality of the disease doesn’t bear out as typical, and they will likely project those associations on those with or at-risk for the disease. As TAL’s explanation of the basics of HD during the episode suggests, many, perhaps most, TAL listeners, educated though they are, likely know little or nothing about HD. The episode offers a needlessly misleading introduction to the disease that has the potential to harm those already suffering from it.

Although, as noted above, I have some qualms about how Vince was tested and about the privacy implications for his relatives of so widely broadcasting his diagnosis, I don’t object to telling the story of a person with HD who killed his father — not even to the telling of the story of a person who filled his father because he has HD. In its own way, Vince Gilmer’s story is an illustration of how we can and should do much better in diagnosing and managing HD and its sequelae (along with similar illnesses). The episode tells the story of a doctor falsely painted as evil, when really he was just sick.

But in the course of exonerating Vince Gilmer of culpable murder, TAL paints everyone with, or at risk of, HD as extremely dangerous. Responsible science communication requires that Vince’s story, as important as it is, be much better contextualized to reflect how unusual it is. I have written to TAL to ask that they consider adding a brief comment to that effect to the podcast version of the episode, to any rebroadcasts of it, and to its blog. I’ll update this post if I hear back from them.

[This blog entry is adapted from one originally posted on the blogs Bill of Health and The Faculty Lounge on April 18, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

We’re All Mad Here.

by Sean Philpott, Acting Director of the Center for Bioethics and Clinical Leadership

One of my favorite movies of all time is ‘As Good as It Gets,’ which stars Jack Nicholson as a grumpy, obsessive-compulsive writer. In one classic scene, he tells his neighbor’s housekeeper to “sell crazy someplace else, we’re all stocked up here.”

This will soon be true, at least for most Americans. There are plenty of crazy people out there: Aurora shooter James Holmes, Philly abortion doc Kermit Gosnell, and the individual who bombed this week’s Boston Marathon. But the ranks of the mentally ill will soon expand dramatically.

The belief that we’re all a little bit nuts is nothing new. In the 1865 novel ‘Alice in Wonderland,’ the Cheshire Cat tells Alice, “We’re all mad here. I’m mad. You’re mad.” Come the summer of 2013, this will indeed be the case. Over 50% of Americans will, under new diagnostic and treatment guidelines, suffer from some sort of mental disorder in their lifetime.

In May, the American Psychiatric Association is scheduled to release the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-V). Often called the ‘psychiatric bible,’ the DSM provides a set of standard criteria for determining whether or not someone is suffering from a mental illness.

The DSM is widely used in the mental health community. Clinicians use it to diagnose patients. Insurance companies use it to determine whether they will pay for treatment. Pharmaceutical companies use it to set drug prices and plan marketing strategies. Policy makers use it to make decisions about which mental health programs to fund and who is eligible to receive government assistance. Lawyers and judges use it to determine if a criminal can be held responsible for his crimes or whether a mother should be granted custody of her kids.

Obviously, there is a strong incentive on the part of many stakeholders to make the DSM as broad as possible. For example, physicians want to get paid for seeing patients, but often can’t if the patient doesn’t have a recognized illness. Similarly, drug companies want to convince patients that they have a treatable condition so that they will pester their doctors for a prescription.

So, while only 5% of Americans will have a severe mental illness in a particular year, under the DSM-V nearly a quarter of us will have a treatable disorder at any given time.  Half of us will need treatment at some point in our lives. That’s a lot of doctors to see and pills to take.

Are we really any crazier than we were a generation ago? Perhaps. Some reliable studies suggest that the incidence of conditions like anxiety, neuroticism and narcissism have increased over the past couple of decades. However, much of the increase in disease prevalence can be explained away.

We’ve also gotten a lot better at detecting mental illness, with doctors more aware of the signs and symptoms of common illnesses like depression, attention deficit hyperactivity disorder, or substance abuse. Increased awareness leads to increased diagnosis. In addition, while there is still considerable stigma and shame associated with mental illness, it has decreased in recent years. People suffering from psychiatric disorders are more likely to seek treatment and to be open about their illness. These are good things.

But what worries me is that the DSM-V also classified conditions that are physical not psychological in nature – such as caffeine withdrawal and obstructive sleep apnea – as diagnosable mental illnesses. It also drops Asperger’s as a separate disorder, lumping it in with other autism spectrum conditions. Soon, people living with Asperger’s will have a new diagnosis, which will affect both treatment and their ability to receive services.

Moreover, we will soon be pathologizing behaviors that would, in the past, be seen as quirky but not necessarily unhealthy. For instance, the DSM-V will include paraphilias – atypical sexual interests like bondage or sadomasochism – as diagnosable conditions. What is for some a natural albeit unusual expression of human sexuality could now affect child custody, employment and insurability decisions.

No wonder then that some prominent physicians have described the forthcoming release of the DSM-V as, “a sad day for psychiatry”. Diagnosing and treating mental illness is a challenge, but it’s a challenge that the American Psychiatric Association’s new guidelines fail to meet. The only thing that these guidelines do is to make us all a little bit crazy.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on April 18, 2013. It is also available on the WAMC website. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

A Suicide Attempt, Part 2

by Jacob Dahlke, Bioethics Program Alum (MSBioethics 2012)

*All names are false. This is my narrative surrounding a case consultation I had conducted as a part of my job as a clinical ethicist. This post will discuss the more clinical details surrounding the case. In particular it evaluates the process ‘we’ followed during the case. The thoughts and opinions are my own, and do represent those of any other health care professional, or of any institution.

We were all relieved to know that Bonnie* would die soon. I don’t say that lightly, or in jest, or in some inhuman or discompassionate sense. But we did things to her body, things that we all thought, with confidence, she did not want us to do. So when that decision was finally made, the weight of air left the room. It was a heavy air. Heavy on Jack and Alison, who had to exercise a type of patience that is so rare, for situations just like this. Heavy on Dad, whose emotions for his recently passed wife had to be paused and set aside, so that he could discuss how he was so sure that his own daughter wanted to die. And so we arrived, to the family meeting to tell the family that Bonnie’s condition had not improved, and had in some sense deteriorated. We needed a new plan for Bonnie’s care, and since we couldn’t talk to Bonnie herself about them, we went to the family. We knew what they would say. They seemed relieved when they could say it, this time with the authority they believed all along that it had: Bonnie would not want any of the present interventions, that she should be put on a comfort care plan and be allowed to pass.

Perhaps the most tragic part of this story is that her dad and Alison even found her in the first place. Dad acknowledged that to me in my first conversation with him. “What if we had been another ten minutes later? Would we even be in this situation?” he asked, slightly angry at his own instinct to rescue his own daughter and the subsequent cascade of events.

But there we were, in this cascade of events that was on an odd sort of autopilot. Known as the ‘rule of rescue’, this standard of medical practice is invoked when patients arrive to a medical facility with unknown context regarding their ability to consent to what we are about to do to them. This rule of rescue is very uncontroversially used in emergency departments. If a patient presents to the ED- unconscious and bleeding- following an auto accident, we automatically treat the person and attempt to treat the injuries without first attempting to obtain their permission. Technico-legally, we are providing justification against future potential charges of medical battery. In the absence of adequate knowledge to the contrary, our medical obligation is to provide full measures of treatment.

Suicide attempts are a bit trickier. The context of the injuries tend to be less obscure. The car accident in the above example doesn’t necessarily correlate to the patient’s wishes to accept or refuse life saving treatments, but a suicide attempt is a little clearer. It is not a logical feat to say that because Bonnie tried to end her life, she would also not anyone else to do things to keep that life going. Some suicide attempts are indeed an act of last resort for a person to get the attention and subsequent help that they need. Depression, reactive to an event or prolonged and intractable, untreated or untreated, could be a cause of the suicide attempt. The suicide attempt is instead a clinical manifestation of an underlying condition, one which has not yet been medically optimized, and therefore an injury that we are obligated to treat as well.

This slight obfuscation, though, is all it takes for suicide attempts to take a different trajectory than other treatment scenarios. Simply put, then: when a patient arrives following a suicide attempt, we aren’t sure they rationally wanted to end their life, or if this was a symptom of an underlying condition for which the patient could also be treated. The rule of rescue is applied here, then, as the window of time in which the patient is to be medically optimized.

Patients have a well established ethical principle in autonomy that ensures that a patient themselves can accept or refuse medical interventions. But in order for that to happen, we must have confidence that they can actually be in such a state as to express their autonomous choice. We call this decisional capacity. It means that the patient can understand and appreciate the proposed treatment, and that they can evaluate the risks, benefits, and alternatives, and can communicate a choice that is consistent with their values. The threshold for capacity increases with the increasing level of complexity of the medical decision. When patients lack adequate capacity to make the decision asked of them, we seek out others (known as surrogates since they are making decisions in place of another person) to make a substituted judgment, where we must ask the surrogate to make the decision as the other person would make it if he or she were able. (I must note that this is often misinterpreted as “deciding to let Mom die”, but that is for another time.)

In this case, Bonnie’s wishes, as interpreted by her family, were clear and consistent. She had written in a note prior to taking her “polypharmacy overdose” that explained why she no longer wanted to live, and requested that her family respect her decision. Her family reflected on the last few years. While she never said explicitly that she would not want to live without Mom, her actions and behaviors made it a predictable outcome. One of the first words I heard to describe Bonnie’s relationship with her mother was “dyad”. The other dominant word was “codependent”. Bonnie had little if any meaningful social structure outside of her mother. Bonnie had a negative self-image, but saw the tolerance in her mother’s relationship, which provided an insulation to anyone else possibly agreeing with her own self-critiques. While the effects of her cerebral palsy were fairly well managed, the diabetes and inability to maintain her weight caused additional problems (she classified as being morbidly obese). Her slow decline in health increased her dependence on her mother. Her mother had a correlative decline in health over the past few years, which increased her dependence on Bonnie for day-to-day tasks. The two of them were dancing each day around each other, very slowly, in a spiral of declining health. Their dance had become so intimate that the removal of either partner would result in the other falling down. This was the assertion of the family.

But our medical reply was the rule of rescue. We are obligated by the principles of beneficence (doing good- preserving life in this case) and non-maleficence (avoiding harm- potentially allowing a person to die who may not really want to) to be more confident, to pause and consider the possibility that Bonnie may have wanted to live. So pause we did. We were in the midst of the rescue event, without any clear timeline for how long it would last. The rescue event would last as long as her conditions upon admission were resolved- her pneumonia, her reliance on organ support for her lungs, and (hopefully) a psychiatry consult to evaluate possible depression. So pause we did.

Bonnie was in the ICU for over two weeks. During that time she was intubated, connected to a ventilator that was breathing for her. She had developed an aspiration pneumonia, which cleared and she appeared well enough to extubate her and removing ventilator support. Once she was extubated, she whispered, “My mom is dead”. That was all. Her breathing didn’t improve however, and had be re-intubated. She never spoke again. She developed another pneumonia. Throughout it all, she was agitated. Really, really agitated. She was restrained due to her repeated attempts to pull out her ventilator tube. She was never really “with it”, mind you; she never regained enough capacity to have an adequate conversation, although she was able to briefly follow simple “yes” and “no” commands. Her agitation declined into a delirium, a common side effect of prolonged intubations and ICU stays. It was at this point that her condition, the totality of her damaged condition, exceeded the raw benefit of establishing a psychiatric baseline. The rescue event was over. It was time to rethink her goals. It was time to have the family weigh in.

I understand the process we followed for this very challenging case. I can cognitively construct the logical course, the ethical justification, and the clinical trajectory of what I did. But what I can’t shake- not yet, at least- is that I was right all along. We were going to prolong this woman’s suffering so that we could be right. Because for us to be wrong would have meant that we violated such foundational principles of good medicine, that we allow to die a person that ought to have lived. I still struggle with that. Part of my struggle is that the process we followed, in my opinion, is flawed. I am early enough in my career to know what I don’t know, and the ethics of suicide attempts I don’t know. But in this case, which I consider a ‘standard’ case, plays out in my head as this: 1) Bonnie wanted to die. 2) Medicine got involved, and needed to be sure she really wanted to die, so she went to the ICU. 3) Her prolonged ICU stay led to complications. 4) The complications of her hospitalization became the primary cause of her hospitalization; her suicide attempt became secondary. 5) The rescue event ended; her goals of care should be revisited. 6) She is unable to participate, so we go to the family to obtain substituted judgment. 7) The family asserts that she wanted to die.

Bonnie got what she wanted, albeit later than she wanted. Medicine got what it wanted, albeit later than it wanted. Then why is it that I feel so broken over this?

[This blog entry was originally posted on Mr. Dahlke’s blog on April 16, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Patenting the Building Blocks of Life

by Michelle Meyer, Bioethics Program Faculty

Imagine a world in which useful inventions, such as drugs, are immediately freely available to all. This world may seem attractive, but the process of invention is often costly and fraught with risk of failure. If everyone else could free ride off of the hard work of the inventor, no inventor might have sufficient incentive to engage in innovation in the first place, and then no one would have the benefit of the invention.

Now imagine a polar opposite world in which inventions are forever the exclusive property of the inventor. Someone invents, say, a saw for cutting down trees, and if you want to cut down trees, you need to either pay the inventor for a license to use his saw or invent your own, different mechanism for cutting down trees. In this world, inventors who collect licensing fees would have ample incentive to invent, but as monopolies, they would hold their inventions hostage to any price they chose to charge.

The centuries-old U.S. patent system is designed to strike a balance between these two worlds, with maximal innovation its goal. By giving inventors property rights in their inventions, the patent system creates incentives to engage in useful innovation that will improve human welfare. And by limiting those property rights to 20 years and requiring the inventor to adequately describe the details of their invention, the patent system ensures that others may use and build on it.

The U.S. Patent and Trademark Office (PTO) issues patents to purported inventors for things (“compositions of matter”), methods for making things, or methods for using things. But disputes often arise over the validity of patents between purported inventors and third parties, which disputes courts often must ultimately resolve, setting precedent for other patents in the process. To be valid, the subject matter of the patent must be novel, useful, and non-obvious. But an even more basic requirement is that the inventor’s claims must concern patentable subject matter. The scope of patentable subject matter is quite broad, encompassing “anything under the sun that is made by man,” according to the legislative history of the 1952 Patent Act, except for (according to past Supreme Court cases) abstract ideas, laws of nature, and natural phenomena.

On April 15, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, a case that will test just how broad the scope of patentable subject matter is by answering question: Are human genes patentable? At issue in the case is the validity of Myriad’s patents on isolated DNA from two human genes, known as BRCA1 and BRCA2. Women who have mutations in one or both of those genes, as most readers know, have a significantly higher chance of developing breast or ovarian cancer, and perhaps other kinds of cancers as well. No one disputes that both the method by which Myriad isolates DNA fragments from human blood is patentable (although Myriad did not invent this method, which has long been ubiquitous in molecular biology and is off-patent). Nor does anyone dispute that the use to which Myriad puts the isolated DNA — a particular disease risk prediction test — is patentable.

But are the isolated DNA fragments themselves patentable subject matter? All inventions are ultimately derived from nature. No one disputes that although a naturally occurring tree is not patentable, a wooden baseball bat made from that tree is, for instance. But how closely may a purported invention resemble nature and still be patentable?

The ACLU, patients at risk for breast and ovarian cancer, and various medical associations have asked the federal courts to declare that neither isolated DNA nor so-called cDNA — synthetic DNA that is complementary to and built off of naturally-occurring RNA — is patentable but are instead simply natural phenomena. Isolating fragments of DNA, they say, simply involves removing from the body a portion of naturally occurring DNA. Just as sawing off the branch of a tree does not entitle the sawer to a patent on either the tree or the branch, they say, removing a fragment of DNA does not entitle Myriad to a patent on either the isolated fragment or the embodied gene.

Turning to the innovation policy behind the patent system, the challengers argue that Myriad’s patents have prevented standard clinical testing of the BRCA genes, inhibited research on these genes, and prevented patients from accessing their own genetic information. They further argue that Myriad’s real contribution wasn’t any invention at all, but, rather, discovering the natural correlation that exists between cancer and specific gene mutations. They say that there are sufficient incentives for academics and others to pursue this kind of knowledge without the promise of a composition patent on genes. Those incentives include recognition and acclaim as well as process and use patents. Justices from both the “conservative” and “liberal” wings of the Court were clearly concerned about the effects on innovation of invalidating Myriad’s patents, and they seemed to find the latter, but not the former, incentives a compelling reason to think that these kinds of important discoveries would continue to be made.

Myriad, of course, disputes each of these points — as do half of the judges who have previously ruled on this case. The Supreme Court has not issued an opinion on what constitutes patentable subject matter in a composition patent in over thirty years, and this older jurisprudence itself is less than clear. In the absence of clarity, when determining whether a purported invention is sufficient different from natural phenomena to be patentable, some judges look to differences in structure, while others look to differences in function. The district court in this case, for instance, held that neither DNA nor cDNA is patentable since the function of both is the same, whether it exists inside or outside of the body. At the appellate level, one Federal Circuit judge, looking solely to structure, argued that DNA is patentable because isolating the DNA from the body necessarily changes its chemical structure. Another judge, arguing that the structural changes here occur only by virtue of the fact of Myriad possessing the DNA outside of the body, concluded that Myriad’s patents must fail. (Challengers in the case similarly note that the very utility of the isolated BRCA genes in predicting disease is that they are in fact identical, in all relevant respects, to the genes as they naturally occur in the proband’s body). Finally, the third Federal Circuit judge argued that both structure and function are relevant and found that Myriad’s patents passed muster on both counts, primarily because this position was consistent with PTO precedent.

On the matter of innovation policy, Myriad notes that it spent some $500m on developing its patents, and that invalidating those patents is likely to set a precendent that will stifle innovation throughout the biotech industry. Some scholars also argue that it is mere “myth” that 20% of the human genome has been patented, and that claims that “gene patents” have impeded medical research and practice are “wildly exaggerated.”

The Supreme Court permitted the federal government to appear during oral arguments. There, it took a middle approach that a majority of Justices seemed to find palatable during Monday’s arguments. Under this theory, although mere isolated DNA fragments are simply natural phenomena and hence not patentable, cDNA, which is man-made, is. Deciding whether an isolated gene fragment (or cDNA) is sufficiently different from that gene as it exists in its natural state ultimately involves making a choice to draw a line somewhere along a continuum marked by the tree at one end and the baseball bat at the other. Rather than allowing such metaphysics to rule the day, the Court may well lean on the purpose that patent law was designed to serve and look to the likely consequences on innovation of its decision. Although the scientific reality is a bit more complex than the DNA/cDNA distinction would suggest, some have argued that the distinction does have the significant benefit of roughly tracking important innovation policy concerns.

The Supreme Court’s ruling is expected in June.

[This blog entry is an original contribution by Prof. Meyer. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

A Suicide Attempt, Part 1

by Jacob Dahlke, Bioethics Program Alum (MSBioethics 2012)

*All names are false. This is my narrative surrounding a case consultation I had conducted as a part of my job as a clinical ethicist. I will (likely) discuss at another time the more philosophical and ethical components of the case, and the dialogue and recommendations will be more objective. For now I find value in exploring simply the human side of it. None of this is fiction; it is, however, a filtering of the clinical information through my own perspective.

Bonnie*, 47, tried to kill herself. No one disputes that. That was clear from the phone call with her brother Jack*, the one in which her brother said that Dad and sister-in-law Alison* were coming back home to get her and bring her to the hospital. Mom wasn’t good, and they were going to move her to comfort care measures. She was going to die soon, and Dad and Alison were going to bring in Bonnie to say goodbye.

That was enough for Bonnie. She sat down and began to write. Her fingers still worked well enough for that, writing. The cerebral palsy may have taken away some, many, parts of her life, but she could still write down the kind of cat food to give Kit. She knew that she wanted to give away all of her clothes to the local Goodwill. She knew, and she wanted her family to know, that she had given this a lot of thought. Years. After all, everyone had that sense about Mom, she really had started to decline over the last two years. Everybody knew she wouldn’t be able to stay much longer. Bonnie knew that too. She also knew that she didn’t want to live without Mom. It’s not that she couldn’t, but that she wouldn’t. She wanted the family to know that, and to respect it. And so she wrote.

I can’t imagine finding my sister, or my daughter, not like that. Not when we are all supposed to go back to the hospital to say goodbye to Mom. I get that. I would have called 911 too. Probably even if I saw the note first, sitting calmly to read it and try to decide how best to understand and honor Bonnie’s last wish- to be left alone. I can rationally imagine myself doing that. But then I would look over, and see Bonnie, next the table where I found the note, dying before my eyes. I would call 911 too.

Once the medical team gets involved, an interesting thing happens. It becomes very, very hard to convince us to honor that last wish. Was she suffering from underlying depression? Was it undiagnosed? Untreated? Undertreated? Was this a rational decision, or an irrational one? How much confidence do we need from the family’s account to stop what we are doing, and to let her pass? I don’t presume to have the answers to, well, any of it. And yet, that is what is asked of me. And so we go, together, to try and find some answers.

Let’s begin medically. Bonnie is intubated, and sedated. She likely aspirated on some of the charcoal she was given to counteract all of the medications she ingested. She now has pneumonia, for which she is being treated with antibiotics. Medically speaking she is in the midst of what we refer to as a “rescue event”. This means that we are in one sense on autopilot. That is, our medical obligation is to complete the event, and attempt to stabilize her until we can ascertain the nature of her actions. For Bonnie, that means we are trying to treat her pneumonia, which will increase the chance we can get her to breathe on her own and remove her from the ventilator. Until that happens, we won’t be able to say with confidence that she didn’t simply react to the terrible news about her mother, and that while difficult, she really wants to live. Primum non nocere; first, do no harm. How harmful is it to withdraw everything at our disposal to let this woman die, if she really wouldn’t want to? No, we need to be more confident.

Bonnie didn’t really seem to enjoy her life the way the rest of her family did. She managed well enough with the recurrent kidney stones, with the mild epilepsy. She worked hard, to be sure, likely harder because of the cerebral palsy. She got her associate degree, and she worked with kids. She worked with three families’ kids – six in all – and was their nanny. From birth to school age, she helped to raise these kids. It sounds like she was pretty good, too. One, now 17, is having a hard time thinking that his “B” may be gone. She eventually couldn’t do it anymore, though, due to her CP.

The weight always seemed to bother her, too. She could never quite get her diet just right, and she seemed genuinely frustrated at the slow but consistent weight gain. It affected her self-confidence, too. Having a social life with cerebral palsy, she could do. Having extra weight may have been manageable too. But both, they both seemed to feed each other, and starve whatever positive image she had of herself, until there just wasn’t anything there. It would likely be hard to put yourself out there and trust someone, even socially, if they hadn’t been there through it all. Seen the slow burn of her CP never improving, of her rarely ever losing any weight and only gaining it. Of getting the regular Botox injections not out of vanity, but out of necessity. She didn’t have friends, then. None that she could trust with anything beyond the superficial. None like Mom at least.

Mom and Bonnie were described as a dyad. Codependent. Yin and yang. Jack and Alison acknowledged it. Dad admitted that he never had that relationship with either of them. He said it with perhaps the slightest tinge in his eye when he says it. Is it jealousy? Sadness? Anger? Regardless, it seemed self-evident that they had a relationship that was far more intimate with each other than with anyone else in their lives. They relied on each other for the day-to-day tasks. They went with each other to the doctor’s appointments. Their health declined together.

I tried to imagine Bonnie’s world, to try to determine her choice could be rational. She made plans for the future. She was a pretty efficient knitter, even having limited function on her whole left side. She knitted stocking caps for kids in a local school. She was planning on making more. She had plans. But I think, I think, that she also knew that on this highway of life that she was on, there was an exit ramp ahead. She didn’t know how far out it was, but she would know it when she saw it. It would be when Mom died. But until then, what’s the point of sitting around and just waiting to die? She may as well knit something in the meantime.

[This blog entry was originally posted on Mr. Dahlke’s blog on April 8, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Stripped for Parts

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

There was an article in the British Daily Mail recently about the possibility that eggs from aborted human females could be used for in vitro fertilization (IVF). The idea is that the ovaries of the aborted female would be harvested, and the eggs cultivated in a lab and then used in IVF treatments where a donor egg is required.  Ultimately, this would lead to the birth of a baby whose biological mother was never born.

I haven’t read any of the study results first hand, so I cannot speak to the scientific accuracy of the article.  Therefore, let’s discuss the issue purely as a hypothetical.

As I see it, there are several ethical issues involved with harvesting eggs from an aborted fetus:

  1.  How do you tell a child (or an adult person for that matter) that their biological mother was never born?  This would be incredibly difficult for a person to process.  Imagine the feeling of knowing that you were given a life to live because your mother died, that you were given a life she never got to experience.
  2. Who owns the genetic information contained in those eggs?  At this point in our society we do not grant the rights of person-hood to the unborn.  So, do we give the right of donation to the woman who had the abortion?  Is the body of the unborn child her property once it leaves her body?  Is it ok to use these eggs with permission from no one?  What kind of genetic testing will be done?  How will this information be used?  There really is no end to the questions and I don’t see how an adequate solution can be developed.  Keep in mind that to give donation rights to the mother alone would be an issue because it isn’t her genes alone she is donating; it is also the genes from the father.

Both 1 and 2 are major ethical hang-ups in my opinion, but what I would really like to talk about in this post is the dichotomy in our society regarding the issue of life.  Consider this scenario:

Jane is 19, in her first year of college, and discovers she is pregnant.  She decides this is not the time for her to have a child and she has an abortion.  Jane was carrying a little girl and at the abortion clinic they ask if she will donate the ovaries from that little girl.  Jane decides to do this; the nurse tells her all about how the eggs she donates will help a couple in need conceive a child.  Jane wants children someday, just not now, and she hates to see anyone who wants a child denied one.  Plus, it means that this whole ordeal wasn’t for nothing; it had a purpose, right?  She feels sort of empty and alone now that everything is done, maybe donating the ovaries will help bring her closure and make that empty feeling go away.

During this time, Tom and Mary are deciding what to do next.  They have tried everything imaginable to conceive and are left with two options: adoption or IVF with a donor embryo.  They consider the pros and cons.  Adoption can take years and there is always the chance that the mother will change her mind.  Can we deal with that they wonder?  They have been at this for 3 years already.  IVF on the other hand…it’s expensive sure, but they can start soon and maybe have a child by next year.

Tom and Mary go to the in vitro clinic and choose to use eggs from Jane’s aborted fetus.  The treatment takes and 9 months later they have a healthy baby girl.  Effectively making Jane, who thought she was too young to be a mother, a 20 year old grandmother.

The fact that we would consider using eggs from an aborted female highlights a real problem in our society: we are confused about life.  We seem to define life as that which is “wanted.”  This is illogical.  How can we justify valuing the eggs (and the life they can potentially produce) more than we value the human girl they came from?  Her little body was simply tossed aside after being stripped for parts.  On one end of the spectrum we are literally tossing life in the trash and on the other we are painstakingly and expensively creating it in a lab.

In our story, Jane wanted to donate the eggs to help a couple in need.  What if she were told about the amazing gift she could give a couple, as well as her unborn child, by choosing adoption?  Would Tom and Mary have been less excited to have this little girl?  Remember, they only decided against adoption because it is an arduous, bureaucratic nightmare, but isn’t there a way to fix that?  And wouldn’t it be well worth our time to help parents waiting for children more quickly find the children who need parents?

A world in which unfertilized eggs are worth more than a growing female fetus is a world confused and conflicted.  We create the very thing we have just destroyed.

I tire of the legal/illegal argument regarding abortion.  Most people, regardless of how they feel about the legality of the procedure, agree that abortion is not ideal and should, at the very least, be rare.  Let’s get creative and have a discussion about how to make abortions rare or even unnecessary.  By changing the conversation and making adoption a decision to be praised and honored in our society we could decrease the overall number of abortions and fix a bit of the confusion in our society about life.

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on April 7, 2013. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Bright Shiny Things

by Sean Philpott, Acting Director of the Center for Bioethics and Clinical Leadership

On Tuesday, the US Centers for Disease Control and Prevention (CDC) released startling new data on the incidence of attention deficit hyperactivity disorder (ADHD) in American kids. According to the CDC, over 6 million children between the ages of 4 and 17 have been diagnosed with ADHD. Despite coming on the heels of April Fool’s Day, those numbers are no joke.

Over the past ten years, diagnoses have skyrocketed. Eleven percent of all school age children in the US have received an ADHD diagnosis, nearly twice the number seen in 2001. Rates are even higher among older kids, with nearly 20% of high school age boys having a diagnosis. One in ten adolescent boys are currently taking prescription stimulants like Ritalin or Adderall to treat the condition.

The reasons for the startling increase in rates of ADHD among American children are unknown. One possibility is that physicians are becoming more knowledgeable about the condition, enabling them to recognize it in their patients. Perhaps, but one of the problems that doctors face is the lack of clear diagnostic criteria for ADHD.

Like other attention or hyperactivity disorders, ADHD is characterized by a diffuse set of symptoms. According to the current version of the American Psychological Association’s Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), symptoms of ADHD ranging from fidgeting to not listening, to talking excessively, to disliking mentally intensive tasks like schoolwork. But it is rare to find a school age kid in the US who doesn’t have some, if not all, of these symptoms, as so artfully suggested by the satirical cartoon South Park (an episode from season 4 entitled ‘Drug Free Treatment’ for those who are interested). Given the subjective nature of these diagnostic criteria, it is likely that the condition is over-diagnosed.

If I had been born thirty years later, I too would likely have an attention deficit diagnosis. In fifth grade, I was “problem child.” I didn’t pay attention, didn’t complete assignments, didn’t remain in my seat, and didn’t stay quiet in class. The reason was not that I had ADHD. The reason was that I was bored. The material being presented didn’t stimulate me intellectually. Luckily, I had a very astute teacher who recognized this. With my parent’s permission, he started giving me more challenging work to do, and my grades and behavior quickly improved.

Unfortunately, thanks to decades of budget cuts, teachers nowadays do not have the same opportunities to work with struggling students. An educator dealing with a classroom of 40 or more kids, while also being expected to write individualized student learning outcomes (SLOs) and to develop metrics and tools for assessing student achievement, cannot devote the time or effort necessary to figure out why a particular child is failing.

Parents may feel similar pressures. So when a kid is struggling in school or acting out in class or at home, frustrated parents and teachers might automatically label the child as ADHD rather than seek alternative explanations for their behavior.

Given the subjective nature of the symptoms – confirmed primarily by talking with patients, parents and teachers, all of whom have an interest in finding quick and easy answers to complex behavioral problems – it is easy to understand why many doctors feel compelled to prescribe medication. Moreover, some savvy kids may seek diagnosis and treatment on purpose, given that ADHD drugs are now popular as study aids on high school and college campuses.

Therein is one of the biggest problems: over-diagnosis leads to over-medication. This isn’t to say that some kids don’t benefit from treatment with drugs like Adderall or Ritalin. Those with severe attention deficit do benefit from treatment, developing the concentration and impulse control necessary to succeed in school and in the workplace. Untreated ADHD can also lead to problems later in life, including alcohol and drug abuse. But for kids with mild ADHD or who are misdiagnosed, pharmaceutical treatment can come with great cost.

In their advertisements and promotional materials, drug manufacturers tend to overemphasis the benefits of treatment while downplaying the risks. ADHD drugs can improve concentration and impulse control but can also have severe side effects, including anxiety, addiction and psychosis.

The CDC’s shocking statistics should serve as a warning to us all. Not that we are facing an epidemic of attention deficit disorders in the US, but that we are likely facing an epidemic of pathologization. What is normal childhood behavior has become, for harried parents, teachers and physicians, a medical condition to be treated with drugs. Increased public awareness and understanding of attention deficit disorders is a good thing, but we shouldn’t rush to the pharmacy for some Ritalin every time that Johnny fails a test or Sally talks back.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on April 4, 2013. It is also available on the WAMC website. Its contents are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]