PRE-EXISTING CONDITION IN THE WOMB?

Thirty-five years ago, our first son was born and, expecting only good things, we happily paid the extra health insurance premium to add him to our policy. 

A few weeks later, the health Insurance company wrote saying they had denied coverage of his medical expenses based upon a determination that he suffered from “a pre-existing condition in the womb.”  He was born with two “medical anomalies” – physical issues that threatened his life and required immediate hospitalization.  He had a tracheoesophageal fistula (meaning there were abnormal connections between his esophagus, carrying food to his stomach, and his trachea, carrying air to his lungs).  And to complicate matters, he only had one lung.  There were no known genetic syndromes to explain his troubles and there had been no expectation of prenatal developmental issues until shortly before he was born when I developed preeclampsia.

At the time when the insurance company was deciding to deny him coverage, the medical team was optimistic about his chances for survival.  He had been born with robust APGAR scores (tests done immediately after a baby is delivered to find out if he had any noticeable neurological, cardiac, or other difficulties).  After he was born, he could breathe on his own.  He was fed through a tube and, with that tube, he was able to receive and benefit from my breast milk.  The doctors and nurses were optimistic that they could help him survive and thrive.  That was not to be the outcome, however.

He never left the ICU at Children’s Hospital Boston.  He had numerous prolonged surgeries – unsuccessful, almost desperate, attempts to remove the fistulas and to restore his esophagus.  He ended up on a ventilator to breathe for him.  Strong drugs were given to ensure he didn’t move and to help him tolerate the high vent settings.  Constant blood draws were required to test his oxygen levels and blood chemistry.  As the months went on, he suffered from daily “blue spells” when his breathing would stop because gastric juices from his stomach would make their way into his lung.  Eventually he died of “cerebral atrophy” – his brain no longer functioned.  A brain scan was done - the inside of his head looked like a shriveled-up walnut.  All those blue spells had deprived his brain of oxygen and there was nothing left inside.  He died after nine and a half months in the intensive care unit with all the high-tech supports available to him BUT without a dime of insurance money available or paid .

I had been pregnant my entire third year of law school and, with my newly acquired legal research skills, I scoured the law libraries to find a way to get some kind of health benefits for our struggling son.  My husband and I spent hours and hours contemplating what bankruptcy would do to our lives – what we thought would be tens of thousands of dollars of debt turned into hundreds of thousands in the blink of an eye.  Eventually I was able to file for benefits through Medicaid because, under an obscure state regulation, our son became a financial ward of the State after residing in the hospital for a month.  His health care was paid for – but not by the insurance company that received and cashed our premium check.  And not until great emotional harm was done to everyone involved – my husband and I faced both our son’s prolonged dying and our own financial death; the doctors and nurses who were made aware of our plight through the billing office; and the legal services lawyer who helped us pursue and procure government benefits for our son as a last resort.  It was a nightmare that is vivid even thirty-five years later.  I shared recently that I suffered an “Anna Karenina” moment when a train rushed by me at Park Street Station as I held a new medical bill in my hand while my son’s body rested in a grave.  I despaired then and I despair now for any other young parents who face the double tragedy of having a child with medical troubles and having to find a way to pay for medical care when they are denied insurance coverage because of a “pre-existing condition in the womb.”  

Carol L. Powers, JD

Co-Founder and Chair of the Community Ethics Committee

Center for Bioethics, Harvard Medical School

In Consenting to Treatment, What Does a Patient Need From a Doctor? Trust? What Else?

By Gordon Bugbee

Patient dignity and self-determination demand consent before treatment. The more consequential or irreversible the treatment, the more informed and explicit the consent should be. But consent, practically and psychologically, rests on trust. (Not necessarily the trustworthiness of the clinician, but how much the patient trusts the physician.)

In the case of major surgery or other consequential, invasive procedure, the surgical consent, affirmed in the moments prior to anesthesia, is at the end of a chain of consents and releases, each of which is predicated on a patient’s trust in the clinician making the request.

The trust a patient places in the surgeon, oncologist or other physician is itself the culmination of a series of trust relationships starting with the patient’s primary care physician (or ER doctor in an emergency). Successive trust relationships, with specialists or a surgeon, are built on and are partly a transfer of trust from one clinician to the next. Institutional affiliation, endorsements by collateral providers, and reputation may also play a role.

The Community Ethics Committee has been wrestling with issues related to informed consent in the context of concurrent surgery (in which the principal surgeon is engaged in operating on two different patients within the same time frame). The CEC's report is expected to be published here this fall. 

This brought us to a wider discussion of consent in general and most recently to a consideration of the underlying relationships. (We were led to this in part by “An entrustment model of consent for surgical treatment of life-threatening illness: Perspective of patients requiring esophagectomy,’ by Martin F. McKneally and Douglas K.Martin; Journal of Thoracic and Cardiovascular Surgery, August 2000.)

Here is a list of some of the dimensions or facets that seem to characterize that relationship as seen from a patient’s perspective, in no particular order.

I (patient) trust you (provider). That means I assume:

• That you are well trained and competent to undertake the treatment proposed
• That you will try your best to take good care of me
• That you are honest with me (‘whole truth and nothing but the truth’) about the benefits and risks of the proposed treatment (or at least with yourself if I am unwilling or unable to hear those things)
• That you are aware of and respect your own limits
• That you will have adequate rest and nutrition before beginning any complicated or taxing procedure
• That you will not allow distractions to compromise my care (or will refer me to another competent and trustworthy provider who can focus on my care)
• That you have confidence in your own abilities and training
• That you will ask for help or refer me to other more appropriate providers when it is in my best interests
• That in any conflict between what’s best for you (or the institution) and what’s best for me, you will place my interests first
• That your treatment recommendations are driven by clinical considerations not your financial or professional interests
• That you will not entrust any part of a procedure or my care to anyone you are not convinced is competent and trustworthy
• That you will align your tolerance for risk with mine. That is to say, if I am willing to undergo a risky, unorthodox or experimental treatment, you will not refuse to provide that treatment (within the bounds of responsible medical practice) to protect your reputation or peace of mind. Conversely, if I am unwilling to undertake a particular course because of the uncertainty of the outcome, you will not apply undue pressure or seek to overturn my decision to satisfy research goals or your personal preferences.
• That you remember, no matter how routine a procedure is for you, it is a big deal for me
• That alleviating my suffering is at least as important to you as treating any illness I may have.
• That you know that I am more than the sum of my medical circumstances.
• That you know that the capacities and experiences that you value most may not be the same for me.
• That my values and preferences may be different from yours and that you will learn and respect any differences.
• That you will not presume to make consequential decisions for me without consulting me (or those who know me best)

This list is no doubt incomplete, and perhaps we all have a slightly different list of presumptions. The more constitutionally pessimistic or experientially jaded among us may think many of these assumptions are hopelessly naive. However, they are, I think, what many of us hope are true when we sign those complicated forms in a haze of anxiety, desperation, anticipation, and analgesics.

Gordon Bugbee is a member of the Boston-based Community Ethics Committee.

'Bioethics Club'

Who has a keener sense of injustice than the high school student? School teachers know that at this critical time of emotional and intellectual growth, students are often ready to ‘dig in’ to dauntingly complex ethical topics, including those surrounding medicine and health care.

This past year, Aliza Bloostein and Michelle Ryder, two seniors from The Rivers School, a small co-ed independent day school in the Boston suburb of Weston, participated in a pilot ‘Bioethics Club’ program.  The students met weekly with me (a Rivers teacher and Community Ethics Committee member)  to discuss ethical questions arising from such topics as transplantation, vaccination, and medical experimentation. Both busy high school students, neither Aliza nor Michelle was able to fit another course into their packed school schedules, but a weekly club, with a stimulating dose of preparatory reading each week, helped them explore in depth some of the social and moral questions arising from science courses and their science internship experiences. 

With the help of Community Ethics Committee mentors Carol Powers and Paul McLean, Aliza narrowed her research focus to a particular area of personal interest, physicians’ duties to non-compliant patients, while Michelle dived into the wave of current literature on CRISPR gene editing technology. At the end of their year in ‘Bioethics Club’, the students proudly presented their work at the April  meeting of the CEC, receiving warm applause and detailed feedback. Aliza’s and Michelle’s research papers can be found here:

http://www.medicalethicsandme.org/p/student-projects.html

In a separate interdisciplinary course on ethics, other Rivers School students have produced projects designed to engage the wider community in ethical reflection about issues in health care such as concussions, transplantation, opiates, and care for the dying. Some of these student projects can be found here:

http://www.medicalethicsandme.org/p/blog-page.html

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We at the Community Ethics Committee hope you find the work of these engaged, creative students as thought provoking as we all did!

Video: Volunteers speaking for voiceless patients

The Value of Oversight in a Century of Promise & 'Cures'

This post, by CEC member Paul McLean, originally appeared on WBUR's CommonHealth blog.

The blood-thinner heparin is not a 21st-century cure. It was discovered 100 years ago by a scientist looking for something else entirely, and is one of the oldest drugs still in regular use.

After my daughter was diagnosed with a potentially fatal blood disorder, heparin played a key daily role in her treatment. We’d wash our hands meticulously, lay out gloves and antiseptic wipes, saline flushes for the access lines to her fragile immune system, and finally the sealed heparin syringe.

For many months, we went through boxes of heparin and never questioned its safety. Never had reason to.

But in 2008, after my daughter was officially declared cured and we’d used heparin for the last time, contamination in the supply from China killed 19 Americans and harmed many others. Writing that sentence still gives me the chills. My daughter survived thanks to medicine, but it also could have killed her.

So you can understand why, as the 21st Century Cures Act sailed to passage, I experienced both excitement and dread.

That heparin contamination was in part due to lax oversight of the drug supply chain. It reminds me why I do not want to see the work of the Food and Drug Administration compromised by overeager drug companies taking advantage of the hopes of desperate patients, and taking shortcuts on safety.

The “giant piñata” of a bill, as science blogger Derek Lowe aptly described the 21st Century Cures Act, is destined to explode in unexpected ways.

I can’t predict whether it will prove to be mainly a bounty of new treatments, a bouquet of hope for patients, or a lollipop for Martin Shkreli, the hated face of pharma profiteering.

As a medical ethicist, I’m most concerned about this potential fallout: that the FDA will be seen as a barrier rather than a protector, and become too quick with the rubber stamp; and that the DNA of the National Institutes of Health will be edited into a form that diminishes basic science.

And as a father, a husband and a patient myself, I’m most concerned that one day, I’ll ask my doctor, “Is this new drug safe? Is it going to work?” And he’ll shrug.

The act undoubtedly will help with the addiction crisis, improve treatment of the mentally ill, and perhaps move research toward a cure for Alzheimer’s and other brain diseases. That is why it has been championed by the American Psychological Association, the American Society for Human Genetics and the American Society for Clinical Oncology among many others, not to mention President Obama.

But in highlighting the act’s benefits, many of the bill’s backers downplayed its potential harms. Particularly when it comes to the FDA, and the bill’s acceleration of the approval process for new drugs and medical devices.

Is the FDA, in fact, a barrier or a protector? I hadn’t thought to frame the question quite that way until reading about another recent news event. At Standing Rock, in the days before the Dakota Access oil pipeline’s setback, some of people gathered there expressed consternation over the media’s frequent description of Native Americans and their supporters as “protesters.” You see, they perceive themselves as "water protectors."

The 21st Century Cures Act sees the FDA as a barrier to drug makers, blocking the companies' pipeline to patients. What I see is that the agency has long served as a protector — and one thing it has protected is trust in the doctor-patient relationship.

Drugs don’t get approved until proven safe and effective — so doctors know they're unlikely to harm a patient and likely to do some good. Doctors need that confidence in the FDA, but it could be put at serious risk by the act's acceleration of the drug-approval process.

Fueling the bill’s attack on the FDA was an unfounded suspicion that the agency keeps readily available treatments and cures from desperate patients. On the contrary, the FDA has responded meaningfully to the urgency of patients and advocacy groups by creating more avenues for expanded access to experimental treatments.

Still, the 21st Century Cures Act portrays the FDA as too tight, too restrictive. Some backers of the bill portrayed safe and effective treatments as the enemies of compassion. But I worry that choosing that type of compassion over caution can cause harm, both immediate and long-term — to patients and to science alike.

My own bias in assessing the bill can be traced to a cure whose credit belongs largely to the previous century. My daughter had severe aplastic anemia, a failure of the bone marrow that leaves a person defenseless against disease.

There was really nothing doctors could do about it until the second half of the 20th century, when scientists — painfully, methodically — gained understanding of the need for compatible tissues, how to keep certain T cells at bay with aggressive treatment, how to get chemo and radiation doses right, and how to make the donor blood supply safe.

Cyclosporine, which suppresses the immune system, changed everything. In 1983, more than a decade after its discovery in Norwegian soil fungus, it was determined to be safe and effective — by the FDA.

Now, aplastic anemia is often curable, as it was for my daughter. Cyclosporine helped her body make peace with her donor’s stem cells. She benefited not only from emergent knowledge of her rare disease but from myriad clinical trials into other diseases that increased knowledge relevant to her illness.

So when I hear about the billions that the 21st Century Cures Act invests in the “Cancer Moonshot," I know cancer patients won’t be the only beneficiaries. A broader common good will be served, even as individual patients are given new hope and sometimes cured.

But my daughter’s cure was grounded in real scientific knowledge, which randomized clinical trials are uniquely able to provide. And though the 21st Century Cares Act includes $4.8 billion for new research at the NIH, that’s press-release money. The real funding will be determined by Congress over the next decade.

Sen. Elizabeth Warren of Massachusetts, who opposed the bill, warned of its potential systemic harms: “Medical breakthroughs come from increasing investments in basic research,” she said. “Right now, Congress is choking off investments in the NIH.”

My annual physical is coming up. In the past, discussing prescription drugs with my doctor, I’ve never felt the need to ask, “Is this drug safe?” I may need to start. I hope he never answers with a shrug.

ASBH Annual Meeting Presentations by the CEC

Members of the CEC will be presenting two panels at the upcoming ASBH Annual Meeting in Washington, DC and we are excited to share our work among the broader ethics community.

On Friday, October 7 from 8 AM to 9 AM we will be at Congressional Room C presenting our Report on Medical Decision-Making for Unrepresented and Unknown Patients.

On Saturday, October 8 from 3:15 PM to 4:15 PM we will be at Congressional Room A presenting our Report on Palliated and Assisted Voluntarily Stopping Eating and Drinking.

We look forward to seeing you there; to hearing your questions, comments, and insights; and to continuing the ethics dialogue!

Chaplains, Decisions & the Most 'Alone' of Patients

By Paul C. McLean, April 14, 2016

In making decisions about medical treatment for patients who are “incapacitated and alone,” as an influential American Bar Association study once described them, there is a tension among medical judgment, ethics and the law that may be necessary but can do harm to a patient’s best interests. 

A judge’s comment from a 2015 California Superior Court ruling captures this tension well: “The court acknowledges that this order will likely create problems in how many skilled nursing facilities currently operate. ...  The court has considered this burden and weighed it against the due process concerns, and finds that the due process rights of these patients is more compelling. The stakes are simply too high to hold otherwise.” 

In other words, however justifiable, consideration of best interests of these patients and the medical judgment of those directly caring for them carried less weight than due process rights. This is a set-up for medical indecision, poor care and moral distress among caregivers.

The patient and care team alike deserve better. And so the question becomes, is it possible that patient best interests, the ethical principle of respect for persons, and the legal guarantee of due process might each be honored? If so, how?

In an imperfect system, the best process increasingly is seen to be a multidisciplinary decision-making committee within the institution, working from clear policy guidelines and including members of the institutional ethics committee.

The Community Ethics Committee, of which I am a longtime member, has just completed its report on Medical Decision-Making for Unknown & Unrepresented Patients, submitting it to the ethics leadership of Harvard Medical School and posting it on this website (see PUBLICATIONS). 

For the first time, I’ve felt it necessary to take serious issue with a CEC report. CEC reports always reflect a group “voice,” and individual differences are not unusual. This time, I see too much difference between the group voice and my own.

The first difference is fairly trivial. Early in this study, I was in the minority in deciding what to call this class of patients. The CEC opted for Unknown & Unrepresented. I preferred, and still do, the designation Unbefriended, for a patient who not only lacks capacity and the voice of an informed, caring, unbiased surrogate, but has no constituency calling attention to the patient’s plight. 

This point is significant because this patient’s strongest advocates, often their sole advocates, are by default the medical team providing care. But in making medical decisions, something crucial is missing: the patient’s values. Without them, it is easy for bias to cloud medical judgement — sometimes concerning decisions about withholding or withdrawing life-sustaining treatments.

The patient is at the mercy of the care team, and the care team is compromised and in many cases experiencing moral distress, which affects more than one patient. The patient deserves better, as does the care team.

I commend the CEC, and in particular our chair and report author Carol Powers, for both recognizing and drawing attention to the invaluable contribution of hospital chaplains in the medical decision-making process for a patient whose wishes and values are a mystery, and who has no one to speak for them. 

This is especially true when treatment decisions must be made inside the institution —  in some cases, “off the radar.” 

A properly trained chaplain can perhaps uniquely advocate for the patient’s values and best interests as well as play a key role in building understanding and confidence in a process prone to public suspicion and distrust — especially in circumstances when limited availability of resources might influence, or be seen to influence, the treatment decision.

In nursing homes, critical care units and other institutions caring for the extremely vulnerable, such pressure on treatment decisions is increasing midway through a 30-year doubling of the nation’s elderly population; Unknown & Unrepresented (or Unbefriended) Patients have scared off or outlived loved ones, and ethical quandaries about their best interests are increasingly common, as are the stresses placed on care providers. Again, both deserve better.

As the CEC has discovered, chaplains play essential roles in medical decision-making processes in San Diego, Memphis and elsewhere. 

However, in elevating the chaplain’s role, the CEC seems to render existing, multidisciplinary institutional ethics committees — often consisting of physicians, nurses, ethicists, psychologists, social workers, lawyers, and community members — almost irrelevant to the process.

I believe this is a mistake, diminishes the recommendation, and potentially harms the CEC’s unique, important and well-earned voice.

The diverse perspectives of a multidisciplinary ethics committee, including chaplains, provide an effective, arguably unique counterbalance to physician bias in a way no single discipline can.

As discussed in this new report, the CEC learned a lesson from its earlier study of decision-making in cases of medical futility. At that time, the CEC recommended creation of an external, quasi-judicial decision-making panel. 

Impressed in particular with the work of the Consent & Capacity Board in Ontario, Canada, I advocated for that model. But as an idea that would require funding and training without much of a constituency to promote it, it was not a practical recommendation in times of austerity. 

Similarly, there is a history of state, local and national groups studying the plight of Unknown & Unrepresented Patients and recommending investment in public guardianship sufficient to meet the need. These recommendations rarely are adequately acted upon. 

Despite clear, expert guidance from multiple studies, too little has changed — except the patient population, which continues to increase. One troubling study showed that incapacitated patients without representatives remain in critical care up to 50 percent longer than similar patients who are represented, an indication of indecision that serves no one’s best interests.

And so the CEC is wise both to endorse the concept of an internal decision-making team, and to attend to the pressing need for public buy-in for such an idea. Elevating the role of chaplains can play an important part. 

An internal decision-making team can be responsive, efficient, accountable, and make decisions focused on the patient and grounded in moral/ethical principles. 

But the best of these internal decision-making teams are by design multidisciplinary, and the CEC seems to have overlooked this.
Two models worth further attention are found in New York (supported by statute, notably) and the Department of Veterans Affairs. Both set clear and accountable policy for medical decision-making within the institution and allow for judicial recourse as needed. 

Essentially, they establish and require a systemic form of due process within the institution, which is crucial for a vulnerable patient who can express neither agreement nor disagreement with care decisions, and whose perceived interests can become lost in a devotion to due process.

There is no perfect solution to this decision-making quandary, and with adequate funding, public guardianship as an extension of the judicial process might well be the ideal. But society’s track record of adequately supporting this with funding and training is not promising.

There also is a certain irony to something missing from the CEC’s report — any mention or recommendation of a role to be played by community members — patients and families included.

These morally and ethically complex decisions require public awareness, buy-in and participation if they are to respect both individual patients and the larger society at whose mercy the patients find themselves. 

As several CEC members know from personal experience, community members increasingly are valued participants on hospital ethics committees. So who better to advise on the community’s role in medical decision-making for an incapacitated, vulnerable community member than a group long dedicated to giving the community a voice in the bioethics dialogue? 

Perhaps this is for CEC consideration, and membership growth, in the future.

I again commend the CEC, and our chair, Carol Powers, for advocating for a vulnerable and marginalized patient, for seeing the wisdom of an empowered decision-making process within the institution, and for validating the role of chaplain.

The CEC is unique in its structure and purpose, its volunteer participants are admirably dedicated to challenging, consequential work, and the teaching hospitals and ethics leadership of Harvard Medical School have been visionary in seeing the value of such a group voice.

Amid the medical profession’s need for public buy-in, the CEC is a model that merits adoption elsewhere.

Love Wins

“Why?” is one of the first questions we humans ask.  Developing ethical justifications to support decisions is an essential part of my participation in the CEC: the details of “why” influences life-and-death decisions made by patients, caregivers, family, and health proxies. Facts are cold.  I believe that real life decisions ultimately depend on love.

The CEC (Community Ethics Committee) works hard to establish a rational basis for conclusions and positions.  But I’m realizing that our emotions usually decide.  I’d like to think that love wins, but lots of emotions have to be considered too.   

When our daughter was making college decisions, I was the rational engineer who got out the whiteboard and made lists of schools, reasons pro and con, and mapped strategy in a perfectly reasoned way.  But neither my daughter nor her mother looked at the reasoned charts, and I ultimately agreed that we would trust our daughter’s gut.  What she felt was the right destination for the next four years of her life was what mattered.  Rational decision making had almost no influence.

The idea that our positions and decisions are based on feelings more than reason was affirmed again when I read about religion’s place in secular medicine:  some basic moral philosophy and meta-justifications are all we have at the end of it.  In any case, authors quit before they get to the best part, the decision on life or death.  I’m convinced now that it is our emotion, “who and what we love” that counts.  

What are stock markets, after all? Numbers going up and down, they are the sum total of investors’ emotions: greed, anxiety and hope. There is not so much fact and reality in the investment world as an emotional index of how the investors feel at that moment.

On the hard ethical decisions that will have to be made by the computer and software programs that will govern self-driving cars, what will the program decide when the car is going at 70 miles per hour, and a child, mother, and baby carriage dash into the road?  It is traveling too fast for brakes to help.  Doing nothing: the child, baby, and mother will surely perish.  There is a choice:   steering to the right, the car runs into some elders at the bus stop who would be crushed. There’s a third option: the program could decide to steer left, off the cliff, and commit car-i-cide, killing both the passenger and destroying the car.  What will your so-smart autonomous self-driving car decide?

 

It is hard enough for a human to make such decisions, never mind an emotionless robot.   In that impossible scenario, the right decision for a person, will most likely be governed by who or what that person loves most.  A dearly loved family member will probably trump any stranger.  To love someone so much that you will do anything for them also means a choice to drive off the cliff and sacrifice your own life, is never entirely off the table.

After letting this stew for a while, and watching the current political spectacle, I also came to the conclusion that not only “Love Wins”, but “Hate Wins” as well.   Our basest animal bigoted racist xenophobic selves will use our love or our hate to drive our decisions. Sadly for some, some decisions will be forced on them by some people who think they know better how others ought to act.  Will our better selves come out and do the kind and compassionate thing?

Reason alone is far from sufficient. When my health care proxy decides whether I live or die, I hope it will be done with love and compassion.

Shukong Ou has been a member of CEC since 2011.

When Medical Ethics Enters the Campaign

Ethical questions in medical care and science will be prevalent throughout the presidential election season. How deeply they are considered will vary greatly. In the past week, two in particular have come to the fore, and how well they were engaged is worth considering.

Asked in Saturday’s Republican debate whether he would consider quarantining Americans returning this summer from the Olympics in Brazil, New Jersey Gov. Chris Christie said, “You bet I would.”

Christie, you will recall, was a vocal supporter of quarantine during the Ebola outbreak, memorably locking up Kaci Hickox in a tent for three days when the nurse returned from caring for Ebola patients in Sierra Leone (though she tested negative for Ebola). So perhaps the certainty of Christie’s reply, now that Zika is the new viral fear, is not surprising.

Rival candidate Ben Carson, a neurosurgeon, countered that “just willy-nilly going out and quarantining people because they’ve been to Brazil, I don’t think that’s going to work.”

In reporting this story, the news service STAT (www.statnews.com) noted that while the World Health Organization has declared a global public health emergency because of Zika, WHO “has not called for quarantining anyone who may have been exposed to the disease. In Zika-affected countries such as Colombia, pregnant women infected with the virus sometimes share rooms in the maternity wards with women who do not have Zika, with only a mosquito net to separate them. There is no evidence the virus can be transmitted through casual contact, or through sneezes or coughs.”

Mortality and care of the dying also became a campaign topic during a town hall sponsored by CNN, when Jim Kirhan, an 81-year-old, terminally ill man, asked Hillary Clinton how she would “advance the respectful conversation that is needed” about physician-assisted dying.

“It's very personal to me and resonates probably with many other people who are elderly dealing with health issues,” Kirhan said. “The question is coming to me as a person who is walking with colon cancer. And I'm walking with colon cancer with the word terminal very much in my vocabulary, comfortably and spiritually.”

The Washington Post said Clinton was “stumped” by the question. So it’s worth considering Clinton’s complete, seemingly impromptu reply.

“I really appreciate your asking the question,” Clinton said. “And I have to tell you, this is the first time I've been asked that question. And I thank you for it, because we need to have a conversation in our country. There are states, as you know, that are moving to open up the opportunity without criminal liability for people to make this decision, in consultation by their families, even, in some cases, with medical professionals. But the issue is whether the medical professionals want to be involved or just be counselors. So it is a crucial issue that people deserve to understand from their own ethical, religious, faith-based perspective. So here's how I think about it.

“I want, as president, to try to catalyze that debate because I believe you're right, this is going to become an issue more and more often. We are, on the good side, having many people live longer, but often, then, with very serious illnesses that they can be sustained on, but at some point, don't want to continue with the challenges that poses.

“So I don't have any easy or glib answer for you. I think I would want to really immerse myself in the ethical writings, the health writings, the scientific writings, the religious writings. I know some other countries, the Netherlands and others, have a quite open approach. I'd like to know what their experience has been

“Because we have to be sure that nobody is coerced, nobody is under duress. And that is a difficult line to draw. So I thank you so much for raising this really important, absolutely critical question that we're all going to have to do some thinking about.”

Even Gene Editors Need an Editor

During the international conference that went by the hashtag #GeneEditSummit, a message on Twitter thanked the Center for Genetics and Society for a clarification: “I know @C_G_S understands my views. But it came out sounding like the opposite.”

Funny how that happens. One might call it an off-target consequence.

Take the official statement that concluded the International Summit on Human Gene Editing in Washington, D.C. (aka #GeneEditSummit).  

You could read the statement in several ways, and that’s how it has been read. Science News reported that human gene editing was given “a green light. The Guardian agreed: “Summit rules out ban.” “No ban, no moratorium,” medical science reporter Lisa M. Krieger tweeted.

But if they’re correct, then explain the New York Times headine: “Scientists Seek a Moratorium on Editing of Human Genome.” The blogging stem-cell scientist Paul Knoepfler tweeted: “Geez. Nicholas Wade misses boat on #GeneEditSummit.” 

Perhaps the confusion is best explained by an exchange toward the end of the summit, when organizers were asked if their statement might be translated into clearer language more easily understood by the public. To which Dr. David Baltimore, principle organizer of the summit and former president of CalTech, said: “You mean it isn’t?”

See for yourself here. 

Baltimore deserves praise him for orchestrating an important three-day conversation that was truly international on a morally, culturally divisive issue — determining appropriate use of emergent technology capable of altering genes in a way that might cure diseases such as HIV, hepatitis-B and sickle cell anemia. Done equitably, few would argue against it. 

The technology also holds the potential to make a range of changes that could be passed on to future generations. This tends to freak people out — notably, those non-scientists whom Baltimore and his colleagues need to learn to communicate better with.

And yet the summit was a good start on the path to trust and social buy-in for such scientific research, and future public engagement planned by the National Academies of Science holds promise.

One of the first criticisms of the summit was how long it took to get a woman to the podium. One of the last concerned the marginal role of religion. That might be understandable in the context of the largely secular world of science, but to have any hope of broad public support on questions that are at least as much about values as science, that can’t persist.

It wasn’t until the final panel on the second day of the summit that religious values were broached. Speaking of his country, a Nigerian hematologist and panelist said: “We are a religious people. We like to pray.” The hall was almost churchlike in response. But one thing the tool known as CRISPR will never successfully edit out of the dialogue is religious values, and when it tries, the off-target cost could be social buy-in. 

Bringing religion into this dialogue will never be easy. Which one? Will it have to pass an evolution litmus test? Swear an oath to embryonic research? Complicated, indeed.

Good, though, that the dialogue has begun.

Getting a Handle on CRISPR/Cas9 (Part 2)

Takeaways from Day 2 of the International Summit on Human Gene Editing. The challenge: Not devoting all of them to legal scholar and doctor of irony Barbara Evans.

(Bios here: http://nationalacademies.org/gene-editing/Gene-Edit-Summit/index.htm)

1. Barbara Evans’ scenario: Couple meets for a date. One says to other: BTW, I’ve had my genes edited. #FutureImplications
2. Janet Rossant, Toronto Hospital for Sick Children: “It’s absolutely our responsibility” to engender public buy-in and trust.
3. In France, UK, US, no plan to launch public debate on gene editing. “It might be a good idea.” (Jennifer Merchant)
4. Listening & wondering: Is germ-line editing a distraction?  The breakthroughs and greatest uses will come with  somatic cells, which are much less ethically suspect. 
5. Yes! Molecular biologist Thomas Reiss makes a case for accessible language (and uses it himself). #HealthLiteracy
6. “What is needed is a very authentic form of public engagement,” requiring that“science learns to communicate with public.” (Keymanthri Moodley, S. Africa) 
7. One concern in a “wild wild west” of gene editing: medical tourism.
8. One concern if there’s a moratorium: “It will only limit the legitimate science” (Ephrat Levy-Lahad, Israel)
9. International regulation would discourage medical tourism, but hard to respect social, cultural and moral/ethical differences among countries.
10. An ethics question: Does principle of double effect have anything to say about the problem of off-target modifications?
11. Public health disease burden in settings such as Sub Saharan Africa is high priority. Hepatitis B and HIV have treatments, not cures, possibly creating a moral imperative for somatic gene editing.
12. Context: In a 6 billion character, 1.1-million page Book of Genome, a single typo causes the disease. (Matthew Porteus)
13. @rocza points out, “a lot of the #GeneEditSummit debate is about values, not science. We need to NOT pretend otherwise.”
14. Can regulation catch up with the science? Would that be a good thing?
15. Barbara Evans again: “The science of regulation is more precarious than the science of gene editing,”
16. Day’s last panel a true international summit: Nigeria, Germany, France, Israel, S. Africa, Sweden, India. 
17. How to silence a room full of scientists: “We like to pray.” (Fola Esan, Nigeria)
18. Religion wasn’t mentioned until Day 2’s final panel (which then was cut short): “Nigerians are deeply religious people.” Nigeria also has high maternal & child mortality and high sickle cell. Again, moral imperative.

Getting a Handle on CRISPR/Cas9

One day into the International Summit on Human Gene Editing in Washington, D.C., I’m struck by how easy it is for a lay person (namely myself) to get lost in the science. That gulf in comprehension complicates the effort to earn public buy-in and trust for use of the new technology.

This summit has brought together policymakers, scientists and ethicists from China, the United Kingdom and the United States in a quite extraordinary attempt to understand and possibly assign limits to the use of emerging technologies that can be as morally troubling as they are scientifically promising. 

It was heartening to hear, early in Day 2, a call for scientists to take responsibility for helping the public understand both the profound benefits and considerable risks inherent in the new gene-editing technology.  (If “Aldous Huxley” and #BraveNewWorld are trending this week, this is why.)

The summit continues today and Thursday, and is available live via webcast.  

I’m especially looking forward to Thursday morning’s session titled “Interrogating Equity.”

What follows are a layman’s takeaways from Day 1, a webcast of which is available for viewing here: 

1. Predicting outcome in a Twitter word count: Yes to treating, curing humans. No to altering humanity.
2. When a child’s leukemia is effectively treated in a new way, there is broad public support. 
3. Questions: When is CRISPR/Cas9 safe to use? When is it therapeutically justified? (Answer unclear as yet)
4. To paraphrasing one presenter: Our capacity for manipulating is greater than our understanding.
5. With gene editing, the shadow of eugenics is unmistakable & maybe unshakable.
6. In that context, “That was then, this is now” is not a convincing argument.
7. It took 90 minutes to hear from the first woman (Alta Charo, U of Wisconsin).
8. The challenge of getting CRISPR/Cas9 to behave: “Off-target modifications” are at heart of concern. Translation: Beware of unintended consequences and collateral damage.
9. Favorite moment: Physicist Jonathan Weissman of UC San Francisco likening gene editing to volume control. Weissman’s dial goes to 11. #SpinalTap @ #GeneEditSummit
10. In helping the public understand, @pknoepfler’s blog is a good model: 

One last thought: This summit in itself is a good step on the path to social buy-in.