Sweeping Sand Under the Rug

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

This past weekend was the Memorial Day holiday, traditionally marking the official start of the summer season. But Memorial Day is more than just barbeques with friends and three-day sales at local department stores. Memorial Day is also the day when we honor the more than one million men and women who have died in combat or from injuries received while serving in the US armed forces. Among those we honor are the nearly 75,000 who have died since serving in the 1991 Persian Gulf War (also known as Operation Desert Storm).

Now, that number may seem surprising. After all, coalition forces suffered few casualties during the liberation of Kuwait.  Less than 300 American soldiers were killed on the battlefield, and only 114 of those were caused by enemy fire. The rest were accidents or friendly fire.

In the two decades since the Persian Gulf War, however, many of those who served  (as well as many of the civilian contractors who supported the war effort) have been come down with a chronic disorder known as Gulf War Syndrome. Characterized by a diffuse set of symptoms — fatigue, headache, memory loss, muscle pain and weakness, arthritis and joint pain, and respiratory problems — the disease now appears to afflict over a quarter of a million Gulf War veterans, or nearly a third of those who served in Operation Desert Storm. Of those affected, activists estimate, over 70,000 have died.

The disease itself is somewhat controversial. Several studies published in the mid-1990s found no evidence that those who served in the Gulf had increased rates of illness, hospitalization or death, at least when compared with veterans who served in other theaters of operation. Based on these and other data, in 1996 the Institute of Medicine (the clinical arm of the US National Academies of Science) concluded that there was no evidence of a unique chronic illness associated with military service in the Gulf. Despite this, and armed with an additional twelve years of data, in 2008 a federal panel known as the Research Advisory Committee on Gulf War Veterans’ Illnesses announced that Gulf War Syndrome is indeed a distinct physical condition.

The cause of Gulf War Syndrome is also unclear. Some blame exposure to Sarin gas or other chemical weapons stockpiled by the Iraqi government. While there is no evidence that Saddam Hussein’s troops ever used chemical weapons against the coalition forces, many soldiers may have been inadvertently exposed during demolition of these weapons during and after the war.

Others suspect that the cause of Gulf War Syndrome is exposure to organophosphate pesticides used to prevent the spread of insect-borne diseases common in the Gulf.  Still others blame the pyridostigmine bromide pills given to troops to protect against nerve gas, or the depleted uranium ammunition used by troops, or the toxic smoke produced when Iraqi troops set the oil fields on fire.

We may never know the cause of Gulf War Syndrome. This is particularly true since the US Veterans Administration (the VA) seems reluctant to study the disease or its causes. Doing so could put the Agency on the hook for billions of dollars in treatment costs. Not surprising then that the Agency is keen to prevent or suppress such research, at least according to testimony presented by former VA epidemiologist-turned-whistleblower Dr. Stephen Coughlin at a recent Congressional hearing.

According to Dr. Coughlin, the Agency prevents VA-supported researchers from publishing “anything that supports the position that Gulf War Illness is a neurological condition.” It also refuses to release data from the ten-year National Health Study of a New Generation of U.S. Veterans, a multimillion dollar study of nearly 60,000 Gulf, Iraq and Afghan war vets.

Similarly, the Agency has also never published the results of the National Cohort of Gulf War and Gulf War Veterans study, a medical survey of some 30,000 Desert Storm vets. Finally, in an act that is either the height of hubris or the height of incompetence, the Agency “lost” over ten years of data from the Gulf War family registry, a Congressionally-mandated study to look for congenital disorders among the children of vets, birth defects that may have been caused by exposure to chemical weapons or other wartime environmental hazards.

What’s surprising to me that Dr. Coughlin’s explosive testimony has not engendered more anger on Capitol Hill. His allegations that officials at the VA — the very federal agency whose job it is to provide treatment and care for veterans and their dependents — may have deliberately suppressed research into the causes of Gulf War Syndrome are shocking. This accusation deserves to be investigated and, if proven to be true, immediate action to correct the grave harm to those suffering from Gulf War Syndrome, those who have died of the disease, and their families needs to be taken.

For 22 years now, sick veterans have been told that they are crazy, accused of being hypochondriacs, or denied benefits because their condition is not related to wartime service. It may turn out, however, that none of that is true. Rather, as has happened too many times before, the government may have sacrificed the health and well-being of military veterans in order to save a couple of bucks. That’s not only shameful, it goes against everything those soldiers fought and died for.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on May 30, 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.]

Printing New Parts

by Jacob Dahlke, Bioethics Program Alum (MSBioethics 2012)

So this happened. “3-D Printer makes life-saving splint for baby boy’s airway.” Take a moment. Let that sentence wash over you for a moment. I envision it as a TV drama, with the surgeon rushing down the hallway, mask on and gloved hands pointed to the ceiling. Turning a corner, through the double doors and into the … IT department? I can hear it now, with the printer noise not unlike the old-school dot matrix printer, grinding and loud.

I suppose the scene was perhaps not quite the same. But the impact may be just as dramatic. 3-D printing is a relatively new technology in general, with home printers around longer than many people realize. And aside from the recent news of 3-D printers being used for other reasons, using them to make body parts compels some space-age style potential. Even this notion of making body parts is not new; I personally had my first exposure to it in 2007 when I had the fortunate opportunity to visit Anthony Atala‘s lab at Wake Forest. Not just bladders, but tissues, heart valves, bones, blood vessels, and soon entire limbs. How does this play into medicine today, and how could it be utilized to enact real change for patients?

One area of obvious impact is in the realm of organ donation. If one thinks about it, organ donation is a raw and crude process. Granted, the field has advanced dramatically since its inception. But the premise has always been fatally flawed, in my opinion; namely, the attempt to combine alien tissues with native ones in the setting of having to suppress an entire immune system. But if the new tissues were somehow recognized as familial – or better, if they were genetically identical to the host – then the rigorous process associated with immunosuppression could be put to rest. And that’s where 3-D printing comes in.

Let’s say I want to print an ear. Traditional printers take the digital image of the ear, use ink and spray it out onto a substrate, paper. It is spit out in a specific pattern based upon its digital instructions. 3-D printers use the same process, but use a more complicated (3-D) set of instructions (multiple pics of the ear to enable a composite image from all angles), with an often plastic-like ‘ink’ that dries as a solid, which can then be built upon by the next layer of printed instructions. The resulting product is a three dimensional object that looks like, well, an ear. But if the plastic-like ink were replaced by a different material altogether, or even by living cells, then the resulting object would have the potential for actually being put to use. Even better, if those living cells weren’t just any old cells but ones from the host himself, then it could be attached without having to trick the body into thinking it’s a foreign object.

I think that this technology holds great promise for medicine, as ethical concerns often arise with limited organs available to donate. It remains to be seen how this can help alleviate this vital but scarce resource, but I cannot help but believe that it will at least will improve medicine in the very near future. After all, “the future is here. It’s just not evenly distributed.” – William Gibson

Besides, 3-D is already passé. 4-D is where it’s at.

[This blog entry was originally posted in slightly edited form on Mr. Dahlke’s blog on May 28, 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.]

What a Wonderful World It Would Be …

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

Earlier this week my dad had surgery.  He has Amyotrophic Lateral Sclerosis (ALS, also known as Lou Gehrig’s disease) and has recently been experiencing pulmonary issues from a weakening of his diaphragm.  The surgery was for the placement of a diaphragmatic pacer.  Basically, he has wires running through his diaphragm muscle, and they gather into a plug on the outside of his abdomen.  He can exercise the diaphragm by connecting to a wall outlet.  The electricity allows the pace maker to move his muscle up and down.

He is one of about 500 people who have had this new surgery.  It was originally developed for patients with spinal cord injuries, but it has been approved by the US Food and Drug Administration (FDA) for humanitarian use in ALS patients.  The pace maker has been seen to slow the deterioration of the diaphragm muscle in ALS.  It helps some patients stave off the dreaded ventilator and is assumed to help lengthen the life and enhance the quality of life for the patient.

Being a patient’s family member at a hospital is a change for me and I am always watching closely to be an advocate for my loved one or to pick up tips if I am impressed with how the workers handle situations.  My observations on these days often end up in my posts.  I believe patient advocacy and interacting well with patients is a vital, but often lost art in medicine.  See my post “Otherwise Alone” for the tale of my aunt and her hospital admission after several mini-strokes.

That post was one of disappointment in the hospital staff; this one however is going to be far more uplifting.  I saw some truly wonderful things at Henry Ford Hospital in Detroit and believe praise should be given generously and that other medical professionals (myself included) can learn from members of their team.

Dad was the first surgery of the day and taken in right on time.  Some of the staff were kind enough to overlook the extra two family members huddled around Dad’s bed in pre-op, that is until his nurse came and cut the party in half.  She didn’t make a great first impression. (lesson: watch the tone, when talking to patients, even when…no…especially when enforcing the rules)  However, she later proved herself to be incredibly kind and thoughtful.  As they wheeled Dad away, Mom and I (the only family left in pre-op) were rather emotional watching him go.  It’s been a long and painful journey on this ALS road and the surgery was another scary step into the unknown.  The nurse was so kind; she put her arm around Mom and assured her that Dad had one of the best surgeons in the hospital and he would take very good care of her husband.  The nurse was calm and patient, she was truly empathetic and nurturing; in total, she was a credit to her profession.

The surgeon had given us a timeline and appeared to speak with us right on schedule.  The surgery had gone perfectly; Dad was breathing on his own and should be awake and able to have visitors within an hour.  The surgeon answered all of our questions and in no way gave the impression that he had anywhere else to be, though I know from experience that he probably had several things on his list that day.  He took time to talk to us about the new device, how we would be trained, and validated our desire to have more than one family member at the training.

Though this surgery can be outpatient, Dad’s surgeon likes to watch his ALS patients overnight to make sure they are not having complications.  Dad was admitted quickly to his private room.  Mom had told the staff earlier that she intended to stay with Dad overnight and that we had his motorized wheelchair with us.  So, when he was admitted he was given one of the biggest rooms on the floor, complete with a couch and extra pillows and blankets.

Dad’s nurse and nursing assistant continued the great care.  His nurse told him about a project she had done in school regarding ALS patients and that she had specifically requested to have him as a patient.  She specifically requested the complicated, wheelchair bound, ALS patient?  Outstanding…I certainly haven’t seen that before.  The last time Dad was admitted to a hospital they didn’t know what to do with him and kept trying to ignore that fact that he had ALS…um…it doesn’t work that way guys…it would be cool if it did, but it definitely doesn’t.  What a refreshing change to have a nurse who truly wanted to care for him, in spite of the complications ALS brings to a hospital stay.

The nursing assistant was another home run, she was Mom’s favorite member of the team: cheerful, hardworking, and helpful.  She never made a sour face when asked to do something, she was eager to help, and willing to allow Mom to help her with some of the tasks.  This was fantastic, Mom takes care of Dad every day and allowing her to help made Dad more comfortable and allowed Mom to pick up some tips on “how the professionals do it.”

At the end of surgery day, the surgical resident came in during his rounds.  Mom and Dad had seen him about 12 hours before and commented on his long day.  He cheerfully said it was normal and he would probably be on his way home in a half hour or so.  He did not give off any of the rushed, overworked resident vibe I so often see.  In spite of his long day, the fact that he was on call, and would have an even longer day tomorrow he sat and chatted with Dad for almost 15 minutes.  He talked about the surgery, how dad was feeling, and reassured him that the shortness of breath he was experiencing was expected and would resolve.  He treated Dad like a friend and chatted with him about why he chose to be a surgeon, he answered all of Dad’s questions about residency and the path to becoming a doctor like it was the first time he had heard them, and then told us about his future plans for his career.  My dad is a social butterfly and can make friends anywhere, with anyone, but it isn’t often you find a physician who will take the time for a conversation like that at the end of a long workday.

Overall, I was extremely impressed with the care and attention given my Dad at Henry Ford this week.  Mom spoke with one of the nurses about the care and how much we had all appreciated their kindness and compassion.  The nurse told her that at Henry Ford they were trained to treat each patient like they were your only patient and give every interaction your full attention.  What a wonderful way to train your employees!  In my opinion it is working well and other hospitals would do well to adopt this policy.

There is no deep bioethical analysis in this post, but I think it is important and can be inspiring to look at the successes in patient care.  Henry Ford cares for the whole patient as an individual, emotionally as well as physically.  This is a monumental task and they made it look effortless.  Imagine if every hospital experience were like this one…

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on May 25, 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.]

Unintended Consequences: Obstruction of Patient Choice

by Sue Dessayer Porter, Bioethics Program Alumna (MSBioethics 2011)

Oregon was the first state to legalize aid-in-dying. Since 1998 it has implemented “Death With Dignity (DWD),” which allows eligible terminally ill people to end their lives peacefully with a legal prescription.

Contrary to fears asserted by the opposition, there has been neither a slippery slope, nor granny panels, nor hordes of people clamoring to Oregon in order to die. With fifteen years experience, DWD has demonstrated successfully that cautious adherence to the law provides safe choice and dignity at the end-of-life.

But in spite of this flawless record, there is increasing obstruction against choosing this autonomous and personal end-of-life option. The problem? As Catholic hospitals merge with financially imperiled medical centers or acquire independent medical practices, they are instituting religious policies which prohibit doctors from any participation with DWD. This restriction applies to all doctors, not only Catholics. Therefore, a Jewish physician treating a Protestant patient is dictated by Catholic doctrine. – Doctors are not even allowed to have a conversation with their patients about DWD, so the “duty to refer” to another physician is not even a consideration.

An unintended consequence? Section 127.885 (5) (a) of Oregon’s DWD Act allows a health care provider to prohibit another health care provider from participating in DWD (http://public.health.oregon.gov/ProviderPartnerResources/EvaluationResearch/DeathwithDignityAct/Pages/ors.aspx). This was a compromise incorporated into the law in order to appease the opposition and move the law forward. But in retrospect, lawmakers in the early 1990’s could not have predicted the merger activity by Catholic hospitals twenty years into the future. The state of medical economics has changed so dramatically in the last two decades, that private practitioners cannot sustain on their own; for survival, they are bought by medical centers. Therefore, doctors who previously supported patients through DWD can no longer do so. Washington state voted DWD into law in 2008 and is facing the same obstacles.

Catholic health care leaders claim to be in a savior mode, in that if it were not for them, many communities would be bereft of medical care. They state that they are “driven by a mission to serve the underserved” and profess a commitment to help every human being (http://www.nytimes.com/2013/05/13/us/hospital-mergers-in-northwest-).” This is a guise of altruism, as patients requiring end-of-life choices are being denied lawful alternatives. This pervasive barrier to aid-in-dying is affecting ever-increasing numbers of qualified terminally ill patients who try to avail themselves of DWD. Because their state voted DWD into law, residents of Oregon and Washington reasonably assume that their doctor-patient relationship entitles them access to aid-in-dying. Although this is a credible expectation, it is proving to be false too frequently.

Doctors are individually protected by conscience clauses to deny services that are in conflict with their personal beliefs. Alternatively, as long as freedom of choice is protected for doctors who do not want to participate in specific procedures, the same principle of choice should be guaranteed for doctors who do choose to offer what they consider responsible, ethical and dutiful medical care. And logically, a patient should be assured their right to self-determination.

Medical beneficence should be defined by the doctor and patient, not dictated by the religious views of a separate entity which controls with economic power.

[The contents of this blog are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Kudos to This American Life

by Michelle Meyer, Bioethics Program Faculty

A few weeks ago, I blogged about a recent episode of This American Life (TAL), “Dr. Gilmer and Mr. Hyde,” about the quest of one Dr. Gilmer (Benjamin) to understand why another, beloved Dr. Gilmer (Vince), had brutally murdered his own father after hearing voices that compelled him to do so. The episode ends (spoiler alert) with the revelation that Vince suffers from Huntington’s, a rare, neurodegenerative disease that causes progressive physicial, cognitive, and psychological deterioration.

Listeners, it seemed to me, could naturally conclude from the episode that it was Vince’s Huntington’s that had caused him to murder his father. That might or might not be true in this particular case. Huntington’s can cause behavioral and mood changes, including irritability, aggression and belligerence. It can also cause (less often) psychosis. But even if Huntington’s caused Vince to murder his father, or somehow contributed to the murder, the extreme violence that Vince displayed — strangling his father, then sawing off his father’s fingertips to preclude identification — is in no way typical of the Huntington’s population as a whole. And so what most troubled me most about the episode was its failure to note just how rare this kind of extreme violence is among those with Huntington’s, just as it is very rare among human beings generally. And so I wrote to TAL, requesting a clarification.

I’m happy to report that the TAL producer for the episode, Sarah Koenig — who had not intended to suggest any causal link between Vince’s murder of his father and his Huntington’s, much less between murder and Huntginton’s more generally — has issued a clarification on the show’s blog, and promises to make a similar clarification in the episode itself, should they ever re-air it. Kudos to TAL, and many thanks to Sarah for being incredibly gracious in our exchanges.

One clarification deserves another. In my earlier blog post, I also worried that some listeners might  conclude that Vince’s father was similarly driven to commit horrific acts of sexual abuse on Vince and his sister because he, too, was (presumably) suffering from Huntington’s (an autosomal dominant genetic disease). Although I think that a listener who didn’t know better could reasonably conclude that Huntington’s causes people to become sexual predators almost as easily as they could conclude from the episode that Huntington’s causes people to become murderers, nothing in the episode suggests that Sarah, Benjamin Gilmer, or anyone else at TAL believe that Huntington’s causes sexual abuse, or that they intended for listeners to reach that conclusion. I regret anything in my earlier post that suggested otherwise.

Again, I’m very grateful to Sarah and everyone else at TAL for hearing me (and other listeners) out and for agreeing to make the clarification — and just in time for HD Awareness Month!

[The contents of this blog are solely the responsibility of the author alone and do not represent the views of the Bioethics Program or Union Graduate College.]

Lara Croft: Cancer Activist

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

In an Op-Ed piece published in Tuesday’s New York Times, actress Angelina Jolie revealed publicly that she had undergone a prophylactic double mastectomy — removal of both breasts — in order to reduce her risk of developing cancer.

Ms. Jolie had a reason to be concerned. Genetic tests showed that she carried a mutation in a gene known as BRCA1, a change in her DNA that greatly increased the likelihood that she would develop breast or ovarian cancer sometime during her life. Cancer-causing mutations in the BRCA1 gene (or a related gene known as BRCA2) are rare, but account for a majority of familial cases of breast and ovarian cancer seen in the US.

Ms. Jolie likely inherited this mutation from her mother, who died of cancer at 56. Based on her test results, doctors estimated her lifetime risk of developing cancer at approximately 87%, probably at an early age. By contrast, the average woman in the US has a lifetime risk of 12%, with diagnosis usually coming later in life.

The decision to remove both breasts could not have been an easy one, particularly for a starlet who is famous for playing buxom femme fatales in movies like Lara Croft: Tomb Raider, Mr. & Mrs. Jones, and Salt. Ms. Jolie admits as much in her Times article. A prophylactic mastectomy doesn’t completely eliminate her risk of breast cancer, only reduces it by about 10-fold.

She is also at increased risk of developing ovarian cancer, but elected not to have her ovaries removed. A prophylactic oophorectomy, as that procedure is known, is an invasive procedure with long-lasting physiological effects, including early menopause, cardiovascular disease, osteoporosis, and loss of sexual function.

With recent advances in reconstructive surgery, there was no need for Ms. Jolie to go public. She wouldn’t have been the only Hollywood star to get breast implants, just one of the few that had a medical reason for doing so. Barring release of her medical records, a serious breech of privacy, no one would have been the wiser.

So why speak out? According to the actress, she wrote about her experience so that other women could benefit. Specifically, so women with a familial history of cancer could get tested for mutations in the BRCA1 and BRCA2 genes and, if necessary, to “take action.”

Having a spokeswoman like Angelina Jolie increase public awareness of breast cancer is good. It is a laudable goal, but it also one that worries me. Women who look to Angelina as a role model might rush to be tested for cancer-causing genes. However, the results of genetic testing have profound consequences — physically, psychologically and for future insurance coverage. In addition, the tests in question are very expensive. A single test costs approximately $3,000, and may not be covered by existing health insurance plans. Many women simply cannot afford to do what Angelina did.

These exorbitant testing costs are due to the fact that a Utah-based company called Myriad Genetics has patented both the BRCA1 and BRCA2 genes. Myriad currently holds a monopoly on testing for breast and ovarian cancer-causing mutations. The legality of this monopoly had been questioned, most notably in a US Supreme Court case challenging a private company’s right to patent human genes. But until the Court’s ruling in October, the company has every legal right to charge what it believes the market will bear.

Given this, only women with a clear familial history breast or ovarian cancer should be tested. But figuring who has such a history is not an easy task. As many as one in eight women in the US will develop breast cancer at some point in their lives, making it likely that most people will have a sister, mother, aunt or grandmother with a diagnosis. People can have as many as two, three or even four female relatives with cancer. But most of these cases will not be associated with mutations in BRCA genes. It takes a trained genetic counselor or skilled physician, using a detailed family tree, to know for sure whether or not a woman is a potential carrier of a mutant gene.

Moreover, for those unlucky few who do carry a mutant copy of BRCA1 or BRCA2, a prophylactic mastectomy or oophorectomy may not be the answer. Ms. Jolie made a carefully considered and informed decision, in consultation with a highly trained team of doctors, to undergo this radical procedure. But there are other less effective but less expensive and less invasive options, including tamoxifen or regular monitoring, that may be the better choice for many woman (particularly those that lack the savvy and resources of Angelina). I’d hate to think that they rushed to have their breasts removed simply because their favorite starlet had done the same.

None of these concerns I voice is meant to take away from what Angelina has done. Speaking publicly about her decision is a courageous thing to do. But the take-home message for women is far more nuanced than get tested and get treated.

[This blog entry was originally presented as an oral commentary on Northeast Public Radio on May 16, 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.]

The Law, Ethics and Science of Re-identification (An Online Symposium)

 

 

from Michelle Meyer, Bioethics Program Faculty

Over the course of the last fifteen or so years, the belief that “de-identification” of personally identifiable information preserves the anonymity of those individuals has been repeatedly called up short by scholars and journalists. It would be difficult to overstate the importance, for privacy law and policy, of the early work of “re-identification scholars,” as I’ll call them. In the mid-1990s, the Massachusetts Group Insurance Commission (GIC) released data on individual hospital visits by state employees in order to aid important research. As Massachusetts Governor Bill Weld assured employees, their data had been “anonymized,” with all obvious identifiers, such as name, address, and Social Security number, removed. But Latanya Sweeney, then an MIT graduate student, wasn’t buying it. When, in 1996, Weld collapsed at a local event and was admitted to the hospital, she set out to show that she could re-identify his GIC entry. For twenty dollars, she purchased the full roll of Cambridge voter-registration records, and by linking the two data sets, which individually were innocuous enough, she was able to re-identify his GIC entry. As privacy law scholar Paul Ohm put it, “In a theatrical flourish, Dr. Sweeney sent the Governor’s health records (which included diagnoses and prescriptions) to his office.”

Sweeney’s demonstration led to important changes in privacy law, especially under HIPAA. But that demonstration was just the beginning. In 2006, the New York Times was able to re-identify one individual (and only one individual)  in a publicly available research dataset of the three-month AOL search history of over 600,000 users. The Times demonstration led to a class-action lawsuit (which settled out of court), an FTC complaint, and soul-searching in Congress. That same year, Netflix began a three-year contest, offering a $1 million prize to whomever could most improve the algorithm by which the company predicts how much a particular user will enjoy a particular movie. To enable the contest, Netflix made publicly available a dataset of the movie ratings of 500,000 of its customers, whose names it replaced with numerical identifiers. In a 2008 paper, Arvind Narayanan, then a graduate student at UT-Austin, along with his advisor, showed that by linking the “anonymized” Netflix prize dataset to the Internet Movie Database (IMDb), in which viewers review movies, often under their own names, many Netflix users could be re-identified, revealing information that was suggestive of their political preferences and other potentially sensitive information. (Remarkably, notwithstanding the re-identification demonstration, after awarding the prize in 2009 to a team from AT&T, in 2010, Netflix announced plans for a second contest, which it cancelled only after tussling with a class-action lawsuit (again, settled out of court) and the FTC.) Earlier this year, Yaniv Erlich and colleagues, using a novel technique involving surnames and the Y chromosome, re-identified five men who had participated in the 1000 Genomes Project — an international consortium to place, in an open online database, the sequenced genomes of (as it turns out, 2500) “unidentified” people — who had also participated in a study of Mormon families in Utah.

Most recently, Sweeney and colleagues re-identified participants in Harvard’s Personal Genome Project (PGP), who are warned of this risk, using the same technique she used to re-identify Weld in 1997. As a scholar of research ethics and regulation — and also a PGP participant — this latest demonstration piqued my interest. Although much has been said about the appropriate legal and policy responses to these demonstrations (my own thoughts are here), there has been very little discussion about the legal and ethical issues aspects of the demonstrations themselves.

As a modest step in filling that gap, I’m pleased to announce an online symposium, to take place the week of May 20^th, that will address both the scientific and policy value of these demonstrations and the legal and ethical issues they raise. I’ll cross-post my own contribution here, but the full symposium will be hosted over at Bill of Health. Participants fill diverse stakeholder roles (data holder, data provider — i.e., research participant, re-identification researcher, privacy scholar, research ethicist) and will, I expect, have a range of perspectives on these questions:

Misha Angrist

Madeleine Ball

Daniel Barth-Jones

Yaniv Erlich

Beau Gunderson

Stephen Wilson

Michelle Meyer

Arvind Narayanan

Paul Ohm

Latanya Sweeney

Jennifer Wagner

I hope readers will join us on May 20.

On Physician Assisted Dying

by Jacob Dahlke, Bioethics Program Alum (MSBioethics 2012)

Death with dignity. Physician assisted suicide. Compassionate choice. Euthanasia. “One of these things is not like the other … ” Okay, so not really. They are pretty much all the same thing, used to describe what just happened here in Vermont. Last night, the Vermont state House approved a Senate amendment that provides legal protection and a strict protocol for physicians to follow. It permits physicians to prescribe a legal dose of medication with the knowledge that the patient will take the full dose with the intent to die. Insert here: your choice of words or phrase to illustrate your support or criticism. My interest is two-fold. First, is this a good thing? That is, is it morally or ethically permissible, or is it morally objectionable and ethically impermissible? Second, is this a good law? Before we get into that, let’s start with words. Words matter. I choose to use physician assisted dying (PAD). I think it is the most neutral, as it implies an active process on the part of the physician without any judgment for or against. If you disagree with that assertion, please simply note that my intent is to describe this topic from a neutral point of view. Thanks.

Autonomy is a well-established principle in both law and ethics. It promotes the right of individuals to accept and to refuse medical decisions regarding their own bodies. A person with decisional capacity must be able to understand (identify the relevant “dots”), appreciate (connect the “dots”) and communicate the risks, benefits, and alternatives of the decision at hand, in order to satisfy a minimum threshold of informed consent. Additionally, their decision ought to be consistent with their known goals and values. An adequately informed patient with decisional capacity may make a rational choice to accept or decline any proposed treatment, even a lifesaving one.

In this case, then, it is argued that PAD is an extension of patient autonomy. I see two variables in the equation: the patient’s decision (acceptance/refusal of the treatment), and the treatment outcome (life prolongation/hastening of death). Patient autonomy asserts that one has the right to accept treatments in order to prolong life, self-evidently the vast majority of medical interventions. Patient autonomy also permits patient to refuse treatments even if they have the prospect of prolonging life- see experimental (or even some traditional) cancer treatments. If patient autonomy finally permits one to refuse a treatment that would hasten their death (such as withholding or withdrawing nutrition and hydration), then PAD would provide an example of being able to accept a treatment that does the same thing- hastens their death.

The criticism of PAD, as I understand it, is that this final quadrant – performing treatments that intend to hasten death – violates the other well-established principles of beneficence and non-maleficence, as they exist in dynamic balance with each other and with autonomy. Physicians are obligated to facilitate the two broad goals of medicine – the maximization of health and wellness, and the alleviation of pain and suffering. PAD is inherently because it sits conveniently between these two. First, it recognizes that the first goal is not achievable due to the terminal state of the patient’s particular disease. Second, it requires a redefinition and expansion of the second goal to allow active physician participation in ending life. This in and of itself need not be controversial; after all, we have all likely heard a variance of the maxim that there are worse things than dying. But PAD in a sense absorbs that maxim into permissible professional action for physicians within the scope of alleviating pain and suffering. Pain and suffering can indeed be alleviated in death, but the question is how involved ought physicians be. When we consider beneficence and non-maleficence, we consider the harms and/or risks of harm against the benefits of the treatment. If we accept that there are worse things than death – such as living with intractable pain and suffering – then it follows that there would likely be no benefit that could outweigh such harms. It in a sense forces the physician to act (in order to benefit), as opposed to refrain from acting (in order to avoid harm). In order to support PAD in this context, then, it requires refining the definition of the physician’s professional obligations. While this ought to be done by physicians and their respective groups (and it is), the legislature, by acting now, is accelerating the process. Good for them? Bad? Ask me in a decade. But my impression is that the legislative process, as I observed it here in Vermont, did not account for this unresolved aspect and accepted as resolved.

So what about the law itself then? The larger implications I will leave to the people far smarter than myself, but I do have some observations of the law, based upon the many discussions we had with people very close to the process here, including some legislators. This is my first experience this close to the legislative process, so my filter is still green, but some of what the bill actually says gives me pause and some concern. For example, the bill defines how a patient needs to be “capable”; that is, it “ “means that a patient has the ability to make and communicate health care decisions to a physician, including communication through persons familiar with the patient’s manner of communicating if those persons are available.” Hmmm. This seems to me some ambiguous middle ground between a person with capacity – which includes the ability for them to communicate their own choice – and between using surrogates who can offer substituted judgment, in which some sort of interpretation is needed. I foresee this as being potentially problematic in enacting at the bedside.

Another potential problem is that it may fundamentally discriminate against those people for whom it is supposedly protects. If this (PAD) is really a good thing, one that ought to be made available, then it ought to be made as inclusive as possible. But because of the limitations themselves such as the communication requirement, then it restricts some patients for whom could benefit. For example, imagine a patient who has suffered such a brain injury that he may be minimally aware but non-communicative. Suppose the patient had an advance directive (or more definitively, a COLST form) stating his wish to end his suffering if he were ever to suffer such an injury. Is this clear expression of his autonomous wish any less valid than someone who can actually speak or write? And yet, this patient would be unable to avail himself of this accommodation under this law.

There is of course no obligation or duty for physicians to participate in PAD, and their physicians cannot be disciplined by their employers or experience other recourse by participating. What is less clear is the facility’s role in permitting PAD on its grounds. One particular phrase of note: “A health care facility may prohibit a physician from writing a prescription for a dose of medication intended to be lethal for a patient who is a resident in its facility and intends to use the medication on the facility’s premises, provided the facility has notified the physician in writing of its policy with regard to the prescriptions.” (emphasis mine) I think I understand the intent of the phrase – to permit facilities to determine their willingness to participate at an institutional level. But the way this is phrased indicates an attempt to lump together hospitals (‘patients’) with other facilities like nursing homes (‘residents’). My sense here is that the letter of the law may interfere with the spirit of the law, but we will have to see how relevant this section becomes.

I must say that the process is a thorough one, particularly in ensuring and documenting awareness of all of the other end-of-life measures, including palliative care, hospice, generic ‘comfort care’ and ‘pain control’. There is a general immunity, for example, for a person who may have taken the lethal dose at home but somehow found himself at the hospital and died in the setting of the physicians withholding full measures to rescue. There has been talk of the strict reporting for the next three years and then a tapering off, but I was not able to find that in the statute itself. I must say I don’t quite get that either, if true. If this is indeed a good law, because it provides strict protection, then why would the reporting of a patient be a good thing now, but not in 2016?

Regardless, it is here. It is what it is, and I honestly consider myself fortunate to be here now.

[This blog entry was originally posted on Mr. Dahlke’s blog on May 14, 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.]

Portrait of a Litterer

by Theresa Spranger, Bioethics Program Alumna (MSBioethics 2012)

Heather Dewey-Hagborg is an American information-artist who, for her latest project, roams the streets of New York looking for cigarette butts, chewed gum, or strands of hair.  She collects the samples, extracts DNA, and has the DNA analyzed in a lab for certain genetic characteristics (race, gender, eye color, etc.).  From these results she uses a computer program and 3D printer to create a 3-demensional image of the person’s face.  Ms. Dewey-Hagborg says that her sculpture is more of a loose representation of the person rather than an exact portrait.  The capability to create an exact portrait may be available in the future, but at this time the analysis needed for that is too sophisticated for our technology.

The idea came to Ms. Dewey-Hagborg from a single strand of hair she found stuck in a cracked piece of glass.  She wondered whose hair it was and what that person looked like.  Ms. Dewey-Hagborg has spent the past year designing the computer program and creating her 3D portraits.  She calls her project “Stranger Visions.”

This project sparks many interesting ethical thoughts and issues.  We shed DNA everywhere we go, every time we scratch an itch, sweep our hand through our hair, lose an eyelash, etc.  The “Stranger Visions” project brings up some interesting thoughts on the use of discarded genetic material.  For instance, how could this technology be used by: a government, scientist, or police force?

Could the police force use this technology in their investigations?  Perhaps it could be used instead of or in conjunction with sketches from witness descriptions?

Scientists could use the information for statistical analysis and profiling.  An oversimplified example of this could be the title of this post, “Portrait of a Litterer.”  Litter could be collected as this artist has done, but then analyzed to profile and answer some questions about those who litter.  Who is more likely to litter: men or women?  Are litterers more likely to have blue eyes?  And so on…

Certainly, the usefulness of the littering example is questionable, but the idea could certainly be transferred to other areas, the possibilities are endless.  The question however: is this type of use ethical?  Do we want statisticians to be able to collect genetic information for profiling?  What rights do you have to samples of your DNA if they are no longer attached to your person?  A host of questions spring to mind, questions with few good answers.  It seems evident to me, that our discussion in society is falling behind technology in the area of genetics.

In my opinion, we need to quickly catch up in our discussion of genetics.  As technologies become more and more sophisticated, the use of our personal genes could become a forefront issue for our society.  We cannot help leaving traces of ourselves behind us for anyone to gather and do with as they please.  So, how do we prevent our genetic information from being used for something against our will?  Is there a way to adequately legislate on this issue?  Should we legislate?  Do we own the hair, skin, saliva, etc. that contains our genetic information?  The questions and strange possibilities this project presents to us are truly endless.

While I believe this project is fascinating and harmless in itself, it should spur us to deeper thought and conversation on this issue of genetic material: ownership, and use.  It should also encourage you to find a trash bin for your gum and/or cigarette butts lest you find your face on an art gallery wall…

Want to know more?   Here are links to some interesting articles…

http://petapixel.com/2013/05/06/artist-uses-found-dna-data-to-generate-photo-realistic-portraits/

http://www.theblaze.com/stories/2013/02/09/artist-reconstructs-faces-using-dna-left-behind-in-nyc-and-a-3d-printer-considers-implications-of-genetic-surveillance/

[This blog entry was originally posted in a slightly edited form on Ms. Spranger’s blog on May 9, 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.]

On Hunger Strikes

by Jacob Dahlke, Bioethics Program Alum (MSBioethics 2012)

“We will not allow a detainee to starve themselves to death and we will continue to treat each person humanely.” Lt. Col. Samuel House.

Under what circumstances can physicians treat their patients over their objections? Do prisoners (or more accurately in this case detainees) have a right to refuse medical intervention? How might a military physician reconcile a situation in which the two professional obligations directly conflict with each other?

Questions like these have arisen in the news recently in which military officials have dispatched medical officers to manage the treatment of detainees at Guantanamo Bay. I personally am troubled by my initial reading of these headlines, but upon my realization that it may have been a purely visceral response, I decided to evaluate the situation a bit more objectively, if possible.

Good ethics begins with good facts; one way to organize those facts is to compile them into four quadrants: medical indications, patient preferences, quality of life considerations, and other contextual features.

Lt. Col. House has indicated that 100 of the 166 current detainees are participating in the strike, although lawyers for some of the detainees said that the number was around 130. Let’s be clear on this: the lowest estimate is that 60% of the detainees are voluntarily withholding nutrition, or nutrition and hydration. The high estimate indicates 78% participation.  21 detainees are currently being fed with nasogastric tubes over their objections. Five of the participants are currently hospitalized, likely due to side effects of malnutrition.

The detainees have not been evaluated for decisional capacity. In a case where that has not taken place, one would presume that a person has the capacity to make their own decisions. Regardless of a person’s capacity to make medical decisions, all persons retain the right to refuse treatments. If a person refuses a treatment, then the physician (or other medical professional) has two choices: they can honor the person’s refusal and manage the person’s side effects of the refusal (malnutrition in this case), or the professional can treat the person over their objection. This is technically medical assault or battery, so a special provision must be made in order to ethically justify it. That provision is that the person is suffering from a psychological, psychiatric, or somatic illness that is interfering with the person’s ability to properly evaluate the medical decision. That is, if the person is too ill to appropriately refuse (they lack capacity), then we can be justified in treating this person over their objection in order to achieve their greater goal of survival or life prolongation. (Since they have not be sufficiently been evaluated for their capacity, one cannot determine whether their goal is to prolong their lives.)

If we cannot make a definitive assessment based upon the first two categories, we must use the latter two. First, a caveat: I am making assumptions and judgments. I try to make them as objectively as possible, but due the general lack of good facts in this case, it will likely be overall inadequate.

These persons are currently detained in a military prison. They have been there for the better part of a decade (many for longer). While they are technically in a legal limbo of awaiting a trial, there are many indications that there is no intent to ever do that. Translated: this is their life, for the rest of their life. The only other prospect is that they get transferred to another prison. For all other practical purposes, they can be considered prisoners convicted of any other crime: they are treated for illness, provided limited access to personal belongings, etc.

There are likely many cultural biases at play in this case, and probably too many to begin to consider. To some Americans the detainees represent the antagonists to our global goals and achievements. “They” attacked “us”, and therefore in this course “we” captured “them”. To others, the detainees represent all that is wrong with America’s relationship with the rest of the world. Muslim v. Christian. American v. the “Middle East”. Us v. them. I contend that all of these cultural biases, while real and present in this case, are irrelevant. What I find interesting instead is the cultural clash among the health care professionals. There is a culture associated with being a health care professional, one that highlights a fiduciary responsibility to reduce suffering, treat illness, and respect individuals. There is a culture associated with being in the military, one that highlights a fiduciary responsibility to provide security, to reduce or eliminated harm or threat of harm. The structures, processes, and outcomes of these two cultures directly conflict here. It is relevant to note that the news has indicated the arrival of Navy medical personnel included “nurses, specialists, and hospital corpsmen who are trained to provide basic medical care“, which indicates to me that the medical personnel did not include physicians. This is an important distinction, particularly if one wanted to criticize AMA president Lazarus’s letter to Secretary of Defense Hagel on the subject. Translated: Lazarus is opposed specifically to treating over objections if it is physicians who are asked to do it, but will not commit to objecting to the practice in general, since the medical personnel are not technically physicians (and therefore technically beyond the AMA’s scope). Classy. But I digress.

One partial justification for the feeding tubes is that some of the detainees (being force fed) have occasionally voluntarily eaten, when removed from the general population of other detainees participating in the hunger strike. A relevant question then is at what point does peer pressure- which still represents an individual’s autonomous decision- change to coercion, which includes a threat of harm to the person? And what if the situation were reversed, and there was peer pressure on detainees to stop their hunger strike? Would the military intervene in that case of ‘peer pressure’? Likely no, because it’s not the peer pressure that matters; it’s that the detainees are doing something (hunger strike) that the military doesn’t want them to.

Ethical principles to consider

For me, this situation abounds in contrasting ethical principles. The first surrounds the right of a patient to express their autonomy, balanced with the health care professional’s obligations to beneficence (doing good- like treating illness or reducing suffering) and non-maleficence (avoiding doing harm, such as standing idly by while a person’s decisions reduces the quality of their health). I repeat my interest in noting that the military personnel are not physicians. (It is surely worth exploring the professional ethical codes for the personnel, but not for this dialogue.)

There is an apparent conflict between beneficence and non-maleficence. This is only perceived however, because we don’t actually know what the detainee’s goals are. If the goal is to minimize suffering, and if living this way is worse than death itself, then it would be beneficent to allow this and harmful to prevent it. It would thus be an ethical violation to treat this patient over their objection. Thus, the military is keeping these people alive, against their wishes… do what with them? Keep them in this limbo state, presumably.

If however, the detainee’s goal is to protest their treatment, to highlight the numerous abuses and illegal that are being imposed upon them, then the detainee’s goal is indeed life prolongation. Their refusal of food and overall nutrition and hydration, then, represents an irrational decision. How can one want to live, and yet refuse nutrition which will prolong your life? Here is a well-written article on the perceived noble explanation by the military that they are preventing suicide.

There is additionally the role that justice plays in this case. If the goal is to prosecute these individuals for their presumed crimes, then I can see an argument to treating them over their objections in order to see them through their course of justice.

In a strictly medical setting, if a patient refuses a treatment, there is a medically ethical obligation to pause and reconsider patient’s goals; if he has capacity, we should honor patient’s right to refuse. To treat the patient with capacity is to violate his rights, thus conducting battery on the person (doing something to him that he doesn’t want). If the patient doesn’t have capacity, we still can’t do something to someone that doesn’t want it. We must go to court, and get special permission to break the law (do something to someone that they don’t want us to do).

But let’s face it, it won’t. This is Guantanamo Bay. The whole place is one big quagmire of questionably dubious if not full-on illegal activity. Its very existence is questioned by the UN as a breach of international law. But I have drawn enough breath for tonight, and clearly I am not the only one thinking about this.

[This blog entry was originally posted on Mr. Dahlke’s blog on May 2, 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.]