Tuesday, April 25, 2017

Video: Volunteers speaking for voiceless patients

Tuesday, March 7, 2017

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 piƱata” 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.

Tuesday, October 4, 2016

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!

Thursday, April 14, 2016

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.

Monday, March 28, 2016

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.

Monday, February 8, 2016

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.”

Friday, December 4, 2015

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.

Wednesday, December 2, 2015

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.
  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.

Thursday, November 19, 2015

The Coming Changes to Informed Consent

You could fit the Golden Rule — Do unto others as you would them do unto you — into a single Tweet and have 96 characters to spare. #Clear&Concise.
The Common Rule, by contrast, runs into the hundreds of pages. #WordyFeds
But at the center of the Common Rule is informed consent, a process that is rarely clear or concise but can be summed up in a Tweetable phrase: Nothing about me without me.
The Common Rule is a set of federal regulations protecting human subjects in government-funded research. Much like the field of bioethics itself, the Common Rule came in response to research abuses, notably including the decades-long Tuskegee syphillis study, where curative penicillin was kept from impoverished African American subjects without their knowledge.  
A new Common Rule is being written and is expected in 2016. Central to this revision is the role of consent at a time when genomic information and vast stores of data and biospecimens (blood, tissue, etc.) hold tremendous potential for development of cures and treatments. But that history of abuse infuses the process with caution, especially as relates to changing consent.
An informative series of forums have been held around the country and are available for viewing on YouTube (one example).
A summary of what is known as the #NPRM (Notice of Proposed Rulemaking) is available here.
Comments are invited until December 7. See details below.
It is the sort of bureaucratic undertaking that makes many Americans’ eyes glaze over. And yet the impact of this policy will be felt for years — on scientific research, medical treatment and the care and trust of the public, especially its most vulnerable members. 
To comment, go to http://www.regulations.gov/#!home, search for docket number HHS-OPHS-2015-0008, and click “Comment Now.” Or, comment by mail to: Office for Human Research Protections (OHRP), 1101 Wootton Parkway, Suite 200, Rockville, MD 20852

Wednesday, July 29, 2015

Decision Making for Unknown & Vulnerable Patients: A Survey

Go straight to the survey, or read on.

The Community Ethics Committee (CEC) has become a valued resource for the ethics leadership of Massachusetts General Hospital, Boston Children’s and other institutions affiliated with Harvard Medical School.

Now you can provide a valuable voice to the CEC in its current study of an especially vulnerable patient population. These patients are known by various names -- unrepresented, unbefriended, adult orphans, etc. -- but the CEC refers to them as Unknown and Unrepresented Patients.

Due to dementia, brain trauma, substance abuse or other reasons, these patients at least temporarily cannot comprehend their medical situation or influence decisions. Further compounding the mystery, they have no one to speak for them, and there is no available documentation of their wishes.

Decisions that sometimes involve life-sustaining treatment can be left to overburdened courts, inadequately resourced public guardianship, or decision-making practices and biases unique to each physician, hospital or care facility. The result ranges from neglect to over-treatment, potentially harming both the patient and the moral values and integrity of doctors and nurses caring for them.

This patient population is growing commensurately with a doubling of the elder population  nationally by 2030. The conservative estimate is that 25,000 of these unknown humans die in American critical care wards annually. Most of these involve a decision to withhold or withdraw life-sustaining treatment.

How, and by whom, ought medical decisions be made for patients who cannot make their own and have no one who knows them well enough or cares enough to make it for them?

You can inform this important project by answering 10 questions in this survey. The time commitment is small, but the contribution is great.

The CEC is grateful for the work of Talia Burstein, a student at Emory College and a graduate of Brookline High School, for her thoughtful and diligent work in creating this survey.

Tuesday, July 28, 2015

Book Review: Robert Klitzman's "The Ethics Police?"

Robert Klitzman insisted on a question mark.
When “The Ethics Police” was in consideration as the attention-grabbing title for Klitzman’s probing and perceptive book about institutional review boards, his initial reaction may also have involved an exclamation point. But key to agreement was a question mark.
Klitzman, a psychiatrist and director of Columbia University’s masters program in bioethics, had no such concern with the subtitle, “The Struggle to Make Human Research Safe,” because that is precisely what his book is about. Making human research safe is indeed a struggle -- a profoundly difficult balancing of the public’s eagerness for cures and treatments with the scientific community’s eagerness to respond.
With $100 billion spent annually on biomedical research in the US, the money at stake is staggering and aggressively fought over, ethical shortcuts are tempting, patients themselves increasingly insist on leap-frogging the science, and the terrain is rife with conflicts of interests.
Klitzman’s interest in research and oversight is not purely professional. His father died at age 78 of a blood cancer after an experimental round of chemotherapy that Klitzman talked him into.
“The treatment had arguably made him suffer more, not less,” he writes. “I wondered whether my mother’s wish to let him die in peace had been right -- whether I had been biased, too ‘pro-science?’”
He wondered, too, whether his father’s doctor had been overly optimistic about the treatment. He took solace in the hope that his father’s experimental treatment contributed to the care of future patients.
Klitzman’s personal story is no less important to “The Ethics Police?” than his bioethics and medical credentials, his experience as a researcher or his interviews with IRB members. Indeed, the personal gives this book its power.
Klitzman’s role in his father’s consenting to treatment -- treatment that Klitzman’s mother opposed -- provides a view into the complexities of informed consent, and the importance of a physician knowing how much to explain so that consent is indeed “informed.” Easier said than done, to be sure.
How much of the decision reflected the father’s wishes, and how much was deference to the son? How ought the physician to have weighed this?
In such a story, informed consent can seem a fool’s errand, as the most important “facts” of risk versus benefit often are known only in retrospect, and yet the consent process has long been widely accepted as crucial to safety in research. For reasons of research integrity and transparency, it’s easy to see the value in requiring that the researcher explain risks and benefits to the patient/subject, and that both actually understand the difference between “patient” and “subject (or, participant).”
“Many of the achievements that have advanced biomedicine have also, by necessity, involved human subjects, posing myriad cultural, ethical, and legal questions,” according to Klitzman. “These trade-offs are so intricate that every year scandals erupt, unforeseen by those involved.”
For more than four decades, institutional review boards, or IRBs, have been responsible for overseeing human research and avoiding those scandals. They in a sense act as arbiters of the social contract: tasked with halting unethical research, approving valid research, and readily recognizing the difference. They also have a reputation among some researchers for slowing the advance of science. Thus, the nickname: ethics police.
Klitzman insists “The Ethics Police?” is not “an anti-IRB book” and credits IRBs with doing “extremely valuable work” as “mandated committees generally struggling to do their best to protect subjects.”
The great irony within the pages of “The Ethics Police?” is that many of these committees, established by Congress in 1974 to ensure research ethics and safety, are themselves subject to little or no scrutiny or oversight. There are now 4,000 IRBs in the US, many essentially playing by their own sets of rules, though all are subject to the federal research regulations known as “the Common Rule.” (A long-awaited revision to the Common Rule may be forthcoming later this summer.)
Klitzman doesn’t see IRBs as police, except in perhaps the exceptional cases -- those controversial occasions that shed more heat than light on the process.
And yet he has had the experience of having his own research mired in IRB quicksand, losing valuable time and opportunity to bureaucratic inefficiency. (In this, it is not hard to see aspects of the debate over 21st Century Cures Act and its intended reforms of the Food and Drug Administration’s processes of drug approval.)
Perhaps “Ethics Traffic Cops” would be the more apt title: keeping safe and ethical research flowing while directing more troubling traffic to an alternate route and avoiding gridlock.
But in no small way, public trust in health care, especially among the marginalized and most vulnerable, is dependent on IRBs to act as guardian at a time when the distinction between research and care is blurring. And yet few know who IRBs are or what they do, and many IRBs apparently like it that way.
Klitzman writes convincingly that this lack of transparency must change. He wants researchers to appreciate that “IRBs are not the enemy,” and more public education about the research and oversight process.
He also calls for greater transparency from IRBs, which can be varied in approach and secretive in practice. According to Klitzman, “Whatever criticisms IRBs provoke, reforms cannot be designed or implemented effectively without fuller comprehension of the perspective of the individuals serving on the boards.”
Also needed, he writes, are studies into “how frequently committees construe and apply regulations differently due to particular psychological and institutional factors, and whether and how educational or other interventions can reduce problematic IRB variations.”
The success Klitzman had interviewing IRB members only underscores the need for more such access.
“I think we need to explore far more the interpretations of ethics,” Klitzman writes. “Many philosophers and others have tended to see ethical principles as simply involving universals that are either present or absent in particular arguments.
“(The interviewees) illustrate how these principles get interpreted and applied in variable ways, molded by broader social, institutional, and psychological influences. This is not by any means to say that all interpretations are equally strong, valid, or well-reasoned: some interpretations are better than others.”
Clinical medicine increasingly turns to multidisciplinary teams for guidance in difficult areas of decision making and care. There is an important place in research for such teams, as well.
According to Klitzman, “We need models that are based not solely on science, law, or ethics, but are instead multidisciplinary, integrating the humanities with natural and social science. Much of research ethics is, and will always need to be, done by consensus, and negotiated over time by a complex array of researchers, ethicists, and others. We should strive to reach the best consensus we can. Much depends on this balance.”

The Ethics Police? The Struggle to Make Human Research Safe. Oxford University Press. Robert L. Klitzman, M.D., author.

 Also posted at paulcmclean.com

Tuesday, May 5, 2015

Student Perspectives on a World They'll Inherit

To date, Community Voices in Medical Ethics has done its most significant work through the Community Ethics Committee. The CEC has studied a number of difficult ethical questions, many of them related to decisions concerning care at the end of life, and given recommendations to the Harvard teaching hospitals through its ethics leadership.

These reports are meant to bring a community voice into the institutional dialogue at the hospitals. You can read these reports on this site under Publications of CEC.

A second aspect of the Community Voices work is in public engagement, and an example of that can be viewed under Transplant Ethics Outreach.

Transplant Ethics Outreach consists of two visual art pieces and a video produced by high school students of Julian Willard, a founding member of the CEC and a member of the Community Voices board. Julian teaches English and founded the Interdisciplinary Studies Department at The Rivers School, a small college preparatory day school in Weston, Massachusetts.

Julian has a bachelor’s degree from Oxford University and a Ph.D in philosophy from King's College London. More recently, he pursued his interests in the bioethics and interdisciplinary education as a Yale-Hastings Scholar in Bioethics (2013-14) and as a Future of Learning Fellow at Harvard’s Graduate School of Education (2014). 

The student videos reflect Julian’s interest in community outreach efforts that promote reflection and discussion of ethical issues associated with contemporary medicine. The outreach materials presented here are part of the student work for an ethics course at Rivers in which students are called upon to integrate the disciplines of biology, literature, and philosophy in order to respond effectively to key ethical questions.

So please have a look at these student perspectives on challenging issues in medical ethics. 

Julian’s passion for bioethics education is also on display in his research paper for Taylor & Francis Online, which proposes an interdisciplinary approach based on the CEC’s report on medical futility. Read Julian’s paper here and the CEC’s report here.

For public engagement to be truly public we need to include young people as well as elders and everyone in between,” says Community Voices and CEC co-founder Carol Powers, “In fact, one could argue that those young people have the most at stake since they will be caregivers and policy makers and patients whose rights and responsibilities, values and health care will be shaped by decisions made today.”

Saturday, April 25, 2015

No Capacity, No Family, No Voice

Jennifer Chevinsky, moderator of the weekly @BioethxChat on Twitter, recently recorded an insightful video message about a growing class of patients who haven't the capacity to understand their medical situation, or express their wishes for care, have nothing in writing regarding their wishes, and no family or close friends who can or will speak for them.

The Community Ethics Committee is completing a report on this patient class for the ethics leadership and teaching hospitals of Harvard Medical School. Chair Carol Powers and colleagues will present at a workshop devoted to the subject May 7-8 at the University of Arkansas for Medical Sciences.

See Chevinsky's video here.

Tuesday, March 31, 2015

Ethics, Ambiguity & "The Emperor"

Ethical decision-making is a balancing act. Sounds simple enough. But finding that balance is about as simple as getting the toxic cocktail right for a round of chemotherapy: Strong enough to do what’s needed, but not too toxic. Benefit and harm in every drop.

There was much to absorb in the first night of “Cancer: The Emperor of All Maladies,” even having read and reread Siddhartha Mukherjee’s remarkable “biography of cancer” that inspired the three-part PBS documentary.

The opening episode did many things right, but nothing captured for me the unyielding ambiguity of cancer care more than one parent’s description of the quest to cure childhood leukemia: “Unspeakably depressing and indescribably hopeful.”

Among the more than 15,000 sending tweets during the opening episode (#CancerFilm, @theNCI), one said she lasted 10 minutes before tuning out. She hopes to make it to 15 tonight, but no promises. Such is the ambiguity simply in choosing to watch while a family becomes a husband, a wife and their despair.

Even as I anticipate the second of three episodes, I’m still struggling with the tension between Sidney Farber’s firm and angrily defended stance against harming vulnerable children and research practices that clearly harmed sick children but in the process transformed childhood leukemia from merciless and fatal to merciless but survivable.

“I will not injure two children to save one,” the chemotherapy pioneer once said in a heated encounter with another pediatric oncologist.

Farber said this in the mid-1960s, when at the National Cancer Institute, Emil Freireich and Emil Frei were increasing survival of pediatric leukemia by experimenting with four toxic chemicals in combination. That was too many for Farber, who was as dedicated as anyone to treating and curing leukemia but saw harm as tipping the balance.

And yet, into the 1960s, no child survived leukemia. Today, nine out of 10 survive it, largely due to the evolving chemo cocktail.

The half-century that produced that astounding fact also led to the elevated place of informed consent in medicine and science. On Monday night, we watched parents absorb some promising news and then have to decide whether to follow the medical team’s advice and give their child over to a randomized trial. “The thought of your child’s treatment being up to a computer is hard to take.” Indeed.

Reality TV gets no more real than “Emperor of All Maladies.” I’ll be watching again tonight. Hopefully for the full two hours. But, as an oncologist might say, no promises.

Cross-posted at paulcmclean.com.
Also see Matthew Herper’s excellent piece for Forbes

Saturday, March 21, 2015

Palliative Care's Highly Placed Supporter (Pope Francis)

In CEC studies of decision making in medical care at the end of a person’s life, two themes have emerged as most important: 
1. The communication skills of the care team, especially the attending physician (in particular, an ability to listen as well as explain).

2. Not waiting till the last minute to involve specialists in palliative care. (The CEC appreciates the care more than the name; we prefer to think of it as compassionate care.)

As CEC chair Carol Powers wrote in a November 2013 letter to the Massachusetts Department of Public Health: “The Committee has three primary concerns about the provision of information on palliative care and end-of-life treatment options. That information must be sensitive to cultural and religious perspectives; it must be in a form that assumes face-to-face conversations with a member of the patient’s health care team; and it must be provided in the context of continued and compassionate care.”

I thought of Carol’s letter, and her testimony to the DPH’s Public Health Council, while reading a new statement of support for palliative care from a powerful voice: Pope Francis. In a letter of strong endorsement to the Pontifical Academy of Life, the pope defined palliative care as “an expression of the properly human attitude of taking care of one another, especially of those who suffer.”

The full text as translated by Vatican Radio follows. A report concerning the letter can be heard here.

Dear brothers and sisters,
I cordially welcome you on the occasion of your general Assembly, called to reflect on the theme “Assisting the elderly and palliative care,” and I thank the President for his kind words. I am especially happy to greet Cardinal Sgreccia, who is a pioneer... Thank you! Palliative care is an expression of the properly human attitude of taking care of one another, especially of those who suffer. It bears witness that the human person is always precious, even if marked by age and sickness. The human person, in fact, in whatever circumstance, is a good in and of himself and for others, and is loved by God. For this reason, when life becomes very fragile and the end of earthly existence approaches, we feel the responsibility to assist and accompany the person in the best way.
The biblical commandment that requires us to honour our parents, understood broadly, reminds us of the honour we must show to all elderly people. God associates a double promise with this commandment: “that you may have a long life” (Ex 20:12) and, the other, “that you might prosper” (Dt 5:16). Faithfulness to the fourth commandment assures us not only of the gifts of the earth, but especially of the possibility of enjoying them. In fact, the wisdom that makes us recognize the value of the elderly person and that brings us to honour them, is the same wisdom that allows us to appreciate the numerous gifts that we receive every day from the providential hand of the Father, and to be happy. The precept reveals to us fundamental pedagogical relationship between parents and children, between the elderly and the young, with regard to the preservation and transmission of the teachings of religion and wisdom to future generations. To honour this teaching and those who pass it on is the source of life and blessing.
 On the contrary, the Bible reserves a severe warning for those who neglect or mistreat their parents (cf. Ex 21:17; Lv 20:9). The same judgement applies today when parents, having become older and less useful, are marginalized to the point of abandonment. And there are so many examples!
The Word of God is always living, and we see well how the commandment proves topical for contemporary society, where the logic of utility takes precedence over that of solidarity and gratitude, even within families. Let us hear, then, with docile hearts, the word of God that comes to us from the commandments – which, let us always remember, are not bonds that imprison us, but are words of life.
“To honour” today might well be translated as the duty to have extreme respect and to take care of those who, because of their physical or social condition, could be left to die, or “made to die.” All medicine has a special role within society as a witness of the honour that is due to elderly persons, and to every human being. Neither the medical evidence and efficiency, nor the rules of health care systems and economic profit, can be the only criteria governing the actions of doctors. A State cannot think of making a profit with medicine. On the contrary, there is no more important duty for a society than safeguarding the human person.
Your work in these days explores new areas for the application of palliative care. At first, they were a precious accompaniment for cancer patients, but now there are many different illnesses, often related to old age and characterized by a chronic and progressive deterioration, that can make use of this kind of assistance. The elderly, first of all, need the care of family members – whose affection cannot be replaced by more efficient structures or more competent and charitable healthcare workers. When this is not sufficient, or in the case of advanced or terminal illness, the elderly can be benefitted by truly human assistance, and receive adequate responses to their needs thanks to palliative care offered in such a way that it supplements and supports the care provided by family members. Palliative care has to objective of alleviating suffering in the last stages of illness and at the same time of assuring the patient of adequate human accompaniment (cf. Evang. Vitae, 65). It deals with the important support for the elderly, who, for reasons of age, often receive less attention from curative medicine, and are often abandoned. Abandonment is the most serious “illness” of the elderly, and also the greatest injustice they can suffer: those who helped us to grow must not be abandoned when they need our help, our love, and our tenderness.
I therefore welcome your scientific and culture efforts to ensure that palliative care can reach all those who need it. I encourage professionals and students to specialize in this type of assistance, which has no less value on account of the fact that it “does not save lives.” Palliative care recognizes something equally important: recognizing the value of the person. I urge all those who, under whatever title, are involved in the field of palliative care, to practice this duty of conserving the spirit of service in its fulness and recalling that all medical knowledge is truly science, in its most noble sense, only if it finds its place as a help in view of the good of man, a good that is never achieved by going “against” his life and dignity. 
It is this capacity for service to the life and dignity of the sick, even when they are old, that is the measure of the true progress of medicine, and of all society. I repeat the appeal of Saint John Paul II: “Respect, protect, love and serve life, every human life! Only in this direction will you find justice, development, true freedom, peace and happiness!” (ibid., 5).
It is my hope that you will continue your studies and your research, that the work of the promotion and defence of life might be ever more efficacious and fruitful. May the Virgin Mother, the Mother of life, assist you and may my Benediction accompany you. Please, do not forget to pray for me. Thank you!