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!

Thursday, October 16, 2014

On Being Mortal

A review by Community Ethics Committee member Kathy Kaditz of On Being Mortalthe important (and, hopefully, influential) new book by surgeon and journalist Atul Gawande:

I finished Atul Gawande's new book, On Being Mortal. It is a quick read, several of the case studies have been New Yorker articles. However, I think it is absolutely brilliant. In very plain language accessible to most, he makes an incredible case for end of life conversations, techniques to make them helpful for patients and families, and the need to stop doing "everything medicine can do" as the default, at the end of life. He addresses death with dignity laws, the need for palliative care and hospice, the uncertainty patients and doctors experience when they cannot fix what is broken. He addresses it all in a historical and cross cultural context. I think we should all read it. It suggests a clear path forward but one that will take time and effort to implement.

Monday, September 29, 2014

Failures of end of life healthcare redux

It's not news that end of life care is broken.  A recap from current discussions; Zeke Emmanuel (yes the brother of Rahm, formerly seen around the White House and presently holding offices in Chicago), and others.

http://www.commonwealthmagazine.org/The-Download/776-Dying-for-a-healthy-end-of-life-conversation.aspx

Every now and then, it is instructive to see what physicians choose for themselves, in end of life health care.  See http://www.radiolab.org/story/262588-bitter-end/, and their obvious rejection of continued treatment in situations where the benefits are hard to identify, other than keeping the body alive.
----------from the article-------
A chart of doctor responses from the Precursors Study:
Preferences of physician-participants for treatment given a scenario of irreversible brain injury without terminal illness. Percentage of physicians shown on the vertical axis. For cardiopulmonary resuscitation (CPR), surgery, and invasive diagnostic testing, no choice for a trial of treatment was given. Data from the Johns Hopkins Precursors Study, 1998. Courtesy of Joseph Gallo, "Life-Sustaining Treatments: What Do Physicians Want and Do They Express Their Wishes to Others?"

Thursday, September 25, 2014

Back to basics

This blog is about medical ethics, I understand that.  But sometimes it's useful to stand back and examine the assumptions of what constitutes "ethics" and "moral behavior."  Most of us would, I believe, consider moral and ethical decisions the domain of people rather than machines, but as computers and software that run on them become ever more powerful, some developments are worth keeping an eye on: autonomous machines that are expected to make moral / ethical decisions. 

$7.5 million is a drop in the very large bucket that could make such a scenario possible, yet the very existence of the bucket should wake us up and think about, and sort out in our heads, what is "right" and "moral" and "ethical."

http://its-interesting.com/2014/06/12/u-s-military-planning-to-build-robots-with-morals/

There have been many and complex arguments taking positions at extremes such as "of course computers will be sentient (and soon!)" to "machines can never achieve awareness that humans do," and every slice in between.

If you have already thought about what you mean by these words, excellent. If not, now's a good time to wrap one's head around this nontrivial topic.  Can an autonomous robot make moral decisions?    Public policy on it depends on thoughtful input.

Wednesday, August 6, 2014

People First, Disability Second


Medicine does not need more cryptic language. And so upon discovering PFL, I did not celebrate the arrival of a new acronym in the world of health-care communication.

What PFL stands for, on the other hand, we should all celebrate.

PFL is short for People First Language, a movement to promote dignity and inclusion for people with disabilities. And unless you’re a headline writer with space limitations, there is no good reason to shorten it. So, Delaware legislators, lose the acronym. But keep the concept. By all means, keep that going forward.

I learned about Delaware House Bill 416 from legal scholar Thaddeus Pope’s blog.

“The legislation creates no new rights or duties,” Pope writes. “But like new legislation in many other states, it improves the vocabulary and terminology in existing law relating to people with disabilities.” 

Some changes are fairly subtle: from “the disabled” to “persons with disability.” Others replace insensitivity with respect: Gone is the term “mental retardation,” in favor of “intellectual disability.” The purpose is to promote dignity and inclusion. You’ll find a chart with more People First examples on Pope’s blog.

“This language emphasizes that individuals are people first, and that their disabilities are secondary,” according to a summary of the bill.

Understanding and clarifying language was pivotal to the Harvard Community Ethics Committee’s recent study of recipient selection criteria for pediatric organ transplantation.

The CEC wrote: “Neurodevelopmental disability, intellectual disorders, and related terms may hold clear meaning for medical professionals and, more particularly, within a transplant center, but they do not seem to mean the same thing from center to center, and certainly they held no consistent or clear meaning among the members of the Community Ethics Committee.”

For patients and families, simply understanding what’s going on in a medical crisis is challenging enough. When consent is needed, obtuse, legalistic and cryptic language can render “informed” consent an absurdity. But so often that is the very language of consent forms.

The forms tend to be written by lawyers, and “lawyers are not good at plain language. We’re good at protecting our clients, but lawyers don’t think about patients understanding.” That from Chris Trudeau of Michigan-based Thomas M. Cooley Law School, in his presentation at the Institute of Medicine’s recent workshop on health literacy and informed consent.

So the Patient First movement’s attention to language is worthwhile -- and not simply for people with disabilities. The World Health Organization has found that even in translation, the world “intellectual” is better understood by more of the public than are “neurological” or “cognitive.” In its report on pediatric organ transplantation, the CEC embraced the term “intellectual developmental disorder” over alternatives for its potential for achieving understanding and engendering trust in the organ transplantation process.

As the World Health Organization said in a 2002 report: “Every human being can experience a decrement in health and thereby experience some disability. This is not something that happens to only a minority of humanity.”

Saturday, August 2, 2014

Understanding Tuskegee's Legacy (Part 1)


First of two parts.

Four decades after the Tuskegee experiments ended, during a workshop on health literacy and informed consent, Dr. Alicia Fernandez of UC San Francisco said something remarkable and even chilling.

“That story,” she said of the infamous research, “most of my (medical) residents don’t know it.

“I guess they didn’t read the paper that day,” she added in disbelief. “But my patients know it.”

At Tuskegee, the subjects knew neither the title of the research (“Tuskegee Study of Untreated Syphilis in the Negro Male”) nor that they’d even been diagnosed with syphilis. When penicillin was found effective for syphilis, they continued to be studied but not treated with it. They suffered, infected others, and many died. This went on for 40 years, with government support.

The research began at the time Nazi doctors were engaged in the infamous work that resulted in the Nuremberg Code. But Tuskegee is in America, and the research continued long past the Nuremberg verdicts. (Good sources for learning about Tuskegee are here and here.) 

Though the men apparently participated willingly, they were lied to about what they were participants in. And so it was fitting that the workshop at the Institute of Medicine in Washington, D.C., coincided with the anniversary of Tuskegee’s end, on July 29, 1972. Tuskegee holds valuable lessons in health literacy, informed consent and the importance of understanding how they relate.

There is no overstating Tuskegee’s legacy of distrust in medicine. Of the major principles of medical ethics -- respect for persons, or autonomy; do no harm; do good; and justice -- Tuskegee betrayed all four.

Disparities in research and treatment are hot policy topics in medicine, and new doctors should understand their inheritance of patient distrust. Dr. Fernandez’s revelation indicates that short memory is another legacy of Tuskegee.

While the D.C. workshop took place, a group of physicians, scientists and interested others participated in a Twitter dialogue about Tuskegee. The events were unrelated, and yet many of the issues raised during the former, including low participation in research among blacks, were addressed in the latter.

“Even growing up my parents told me about this,” one participant tweeted. “Many blacks know of it and fear any ‘research’ about them.”

The TweetChat was organized around the hashtag #NSTNSchat. The acronym stands for National Science & Technology News Service, devoted to inspiring academic and professional interest among African-Americans in science, technology, engineering and math, or STEM for short.

“Are African-Americans still afraid of being exploited by science?” #NSTNSchat participants were asked. The answer is yes, but there is much more to it, and the dialogue was rich with insights into the role and importance of bioethics, strategies for affectively addressing health disparities and distrust, and the need for more African-American STEM specialists. 

Key players behind the dialogue were Dr. Caleph Wilson of the University of Pennsylvania, Princeton sociologist and author Ruha Benjamin and Dr. A. Breland-Noble of Georgetown. So engaged was this TweetChat, with so many different voices, that it went well beyond its allotted time.

The #NSTNSchat transcript is long and has many threads. So I tried something different in writing about it. I captured many of the main tweets and edited them into story form. It is constructed of the actual tweets, mostly verbatim, with some editing mainly to spell out abbreviations and acronyms, add punctuation and subtract redundancy. Context might change some from the original dialogue, and the tweets are presented as one voice, not multiple authors. 

The composite story appears in the blog post below. The original Tweets, and their authors, can be found on the Storify transcript.

For more about the National Science & Technology News Service, visit the website, and follow  @TheDarkSci on Twitter.

Understanding Tuskegee's Legacy (Part 2)


Second of two parts. This story is constructed entirely from Tweets in a chat organized by National Science & Technology News Service. See the original transcript here 


To understand the Tuskegee study, you have to understand it within the context of racism. The US apologized for the Tuskegee Syphilis Experiment, led by the US Public Health Service on rural African American men, 65 years after it occurred. President Clinton apologized for the government’s involvement. But was that enough?

Tuskegee plays a role in minimal participation of blacks in clinical trials. The impact of the syphilis study can be seen today in huge health disparity gaps. Lingering mistrust of clinical research is real and valid even for those of us in the industry.

It matters because it still impacts why so few clinical trials include African-Americans and other people of color. Mistrust of medicine leads to many people not asking questions of doctors about their care and to low medicine adherence.

Tuskegee should make us wary about all invocations of research for “the greater good” -- great and good for whom? Who decides?

Consider that many people are still afraid to ask their own doctors demanding or insisting questions. Minorities and vulnerable people need to ask more questions. Easier said than done  with underlying fear and mistrust. 

Fear is a byproduct of powerlessness. So you don't treat "black mistrust" simply with more information, but with empowerment. Trust-building is not a function of giving people facts. I wish public health researchers understood this. We need more minorities and people of color in the feeder disciplines that lead to folks going into bioethics.

We should be at community health fairs and screenings, libraries, blood drives, etc. True community participation in research requires sharing power and benefits from research. I've heard researchers say they don't know where to find patients to include. If you don't look for us, we can’t be there.

I wonder about how much the men and their families actually trusted the senior officials and just deferred instead. The men were denied treatment for their disease for many, many years even after treatments became available.

Informed consent means nothing if you don't understand the implications. The main reason I hear when people give consent: "Maybe this will help my kids, grandkids, etc."

Are there structural barriers preventing minority patients from increasing research participation? I think that, as much as a lack of diversity, it is a lack of cultural awareness on the part of the researchers. Non-minority researchers need to educate themselves and then advocate for peers to be better.

Mistrust + lacking public health outreach = research gaps.

Discussions need to be proactive. It shouldn't be relegated to Black History Month at our institutions. Educate ourselves as to what questions to ask researchers and insist those questions are answered to their satisfaction.

What is mistrust turning us into? Perhaps we should invest more in treating ailing social order: inequality makes us all sick.

Community-based participatory research is so important. Partnering with communities helps build trust. Work WITH people of color, and not ON, and trust will be built. 

Let’s reframe mistrust -- not as an OBSTACLE to overcome, but as a set of INSIGHTS into flaws of the medical and social system. “Cultural mistrust” can be protective, even healthy and appropriate. Patients know when to trust. They can feel it.

Science is not an inherently noble value or cause. Applying bioethics allows what we do to be noble. Without justice at center, bioethical principles can be used to legitimate unjust practices. IMO, too often people rely on "but the IRB said it's OK." Institutional Review Boards are human, too.

I'd like to think that we've learned to be more ethical in research as a result of Tuskegee. Prison studies say otherwise. Applying bioethics is key. Deadlines, timelines, dollars & powers that be will always exist. Bioethics keep us honest.

Bioethics 101: these are *real* people with *real* lives, not petri dishes and control agents. 

As we discuss importance of research, remember importance of developing relationships with and within communities  Too many scientific "centers of excellence" and not enough community engagement -- also part of the trust problem.

The original sin of Tuskegee was the devaluation of black humanity.

I've learned there’s too much emphasis on "black distrust" as cultural pathology: W.E.B. DuBois: "How does it feel to be a problem?" 

Saying "black distrust" makes it sound like there's no issue with institutional trustworthiness. We need to place more emphasis on trustworthiness of our institutions. "Black distrust" diverts attention. 

I've also learned that African-Americans can teach researchers a lot about how to do our work, if we just ask. We need a scientifically literate population. It's a public health issue!

The problem was devaluation of black humanity, which helps explain so much in our community. We need to get past Tuskegee and expand the conversation of minorities and ethics.

This is why diversity of the research workforce is so key. We must have diverse investigators to inform equity.

We have a long and winding road ahead of us, and African-Americans have legitimate concerns re: research. Listen to community. Don’t make assumptions. Ask questions before acting. The solution isn't to cure cultural pathology, It's to end racism in research.

We can never give up on our quest to stay in the biomedical science enterprise. There is strength in diversity.

Institutions need to show actual steps they've taken and are taking to protect patients; no ambiguous bullet points. Healthy skepticism is good. Keep asking questions. Refuse to be ignored. Be your own advocate.

Biomedical research industry has to be more of an advocate in all socio-economic realms that impact health disparities. What more should the biomedical research community do to earn the trust of people of color? Shut up and listen.

Do you believe lack of diversity in science researchers makes a difference in building trust?

Can I *like* that question about a billion times!?

For more about the National Science & Technology News Service, visit the website, and follow  @TheDarkSci on Twitter.



Tuesday, July 29, 2014

Lighting a Fireball Under Informed Consent


The experts and their PowerPoints gathered in the nation’s capital. The purpose was to advance an important effort by the Institute of Medicine to improve communication and understanding between doctors and patients and researchers and subjects. No simple task, this.

Best practices were discussed, and one received special attention. Alas, amid the downpour of information during Monday’s daylong webcast of the Institute of Medicine’s workshop on informed consent and health literacy, I seem to have missed this most important of best practices.

I did hear that this particular best practice “increased comprehension better than the other modalities.”

And perhaps that’s why I missed it. I don’t speak in modalities, and that phrase highlighted for me the potholed intersection of informed consent and health literacy. Further complicated by language barriers, informed consent becomes a foreign concept in a time one presenter called “the wild west of data.”

The Institute of Medicine workshop was impressive, informative, perhaps even visionary, and concluded with a call from Dr. Michael Paasche-Orlow, professor of medicine at Boston University, not for simple tweaks but for a course change in scientific and medical culture -- “from persuasion to pedagogy.” (There’s one of those words again; I believe he meant a change from pleading to teaching.)

In particular, this course change demands attention to improved communication skills, so that when a doctor like Jeremy Sugarman of Johns Hopkins tells his patient she has “fibroids in the uterus,” and she hears “fireballs in the uterus,” he’ll know it and correct it.

Overcoming such language barriers, said Dr. Alicia Fernandez of UC San Francisco, “will improve informed consent for all patients.”

According to Fernandez, 21 percent of Americans speak a language other than English at home, and she cited a University of Washington study in presenting a troubling snapshot of medicine as practiced through interpreters. More hopefully, she said, when physicians are bilingual, “communication is more likely to be patient-centered.” 

Sugarman cited his patient’s “fireballs in the uterus” to humorous effect. Another patient heard him describe the “insensitive care unit,” and a diagnosis once was quoted back to him as “sick-as-hell anemia.”

But a malaprop is only a problem if the doctor doesn’t know he or she has been misunderstood. If the doctor knows, a discussion and better understanding might follow. And even, perhaps, truly informed consent.

Even among scientists and medical professionals, the obligations and purposes of informed consent are not universally clear, in part because they are not always the same. Consent is better understood as a process than a form, and it differs greatly for a patient than for a research participant (for whom there may be no expected benefit from what is being consented to). And consent forms are full of legalese.

“I have a lot of problem with the writing (in consent forms),” said Chris Trudeau of the Michigan-based Thomas M. Cooley Law School, whose PowerPoint included the before and after of a consent document. It was indecipherable in its original form, significantly more accessible following his surgical removal of polyps and the like. “Lawyers are not good at plain language. We’re good at protecting our clients, but lawyers don’t think about patients understanding.” 

The workshop itself neglected patients. Notably missing were patient and community perspectives, but to the credit of the members of the roundtable, and their chair, Dr. George Isham, they won’t long be absent from this process.

“What I see missing in this room are patients,” said Dr. Kenneth Saag of University of Alabama-Birmingham, “and people with a high school education or less, and there’s not as much diversity here as we’re dealing with.”

Sandra Crouse Quinn, a professor at the University of Maryland, noted that institution’s effort to address low participation in research by people of color via the program Building Trust Between Minorities and Researchers. “Minorities increasingly are willing to participate in research,” she said, “but they’re not participating.”

“A lot of us are too close to these issues,” Isham said toward the workshop’s end, “and don’t see the forest for the trees.”

With patient and community perspectives, the focus might improve.

See more about the workshop here