John Donnelly – The blog of the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues Mon, 09 Jan 2017 23:23:29 +0000 en-US hourly 1 Quotes: A discussion on whole genome sequencing Thu, 17 May 2012 21:51:08 +0000 For more than a year, the Presidential Commission for the Study of Bioethical Issues has been examining privacy issues raised by the emergence of low-cost whole genome sequencing.

The technological advances and jump in the use of the tests – the costs of whole genome sequencing could drop to less than $1000 this year – have elevated a range of ethical dilemmas about privacy rights and access to data.

At today’s meeting, the Commission discussed issues around genomics sequencing for more than two hours. Some of the comments:

Amy McGuire, J.D., Ph.D., Associate Director for Research, Center for Medical Ethics and Health Policy, Baylor College of Medicine: “In genomics research, there has been a culture of very open and broad data sharing and access to data. When the field got started, the idea was that they wanted to make data as widely available to other researchers as possible. … In today’s day and age, people continually on a daily basis waive their privacy rights because they perceive the benefits to outweigh the loss of their privacy.”

Madison Powers, J.D. D.Phil., Senior Research School, Kennedy Institute of Ethics, and Professor of Philosophy at Georgetown University: “Sometimes the disclosure of genomics information disrupts your community life, your home life, your family life.”

Commission member Raju Kucherlapati, Ph.D., the Paul C. Cabot Professor in the Harvard Medical School Department of Genetics: “Look at me. I’m short, bald, I’m a brown-skinned person. All of these things could be used to discriminate against me. They say, Raju is short. It’s happens all the time. Go to the Internet and people get a lot of information. A lot of people put all the information on Facebook. People are blogging about what they are doing every day. There is a lot of information out there. What is so special about genomics information? What is it that people are worried about? How are they going to make fun or you and socially discriminate against you?”

Greg Biggers, Board Member, Genetic Alliance, and Chief Executive Officer, Genomera: “What do patients want? We want control and influence over data and tissue and outcomes. Yes, you have to ask to use our tissue and data. We want trust, we don’t want to do this in an environment of confrontation. If desired, we must return information to participants. We want research to flourish and we want to join in a common cause to make a difference. We will be shareholders in a common cause.”

Leonard d’Avolio, PhD., Associate Center Director for Biomedical Informatics, VA Boston Healthcare System: “Genomics sciences will not happen without a huge number (of participants), and too many of our policies are absolutely inadequate of where we need to be. It’s great seeing (technologies) develop outside health care, but it’s a shame it’s not happening in our health care system.”

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Weighing the risks of an anthrax study for children Thu, 17 May 2012 20:57:30 +0000 On one side: Does enrolling children in an anthrax vaccine trial put them at risk?

On the other: If there are no trials, does that put all children at risk in the event of an anthrax attack?

The Presidential Commission for the Study of Bioethical Issues today heard several medical and ethical experts address the question whether the Commission should recommend an anthrax vaccine trial in case of a widespread anthrax release.

“How do we balance … exposing children to a potential risk (in taking the vaccine) against the uncertain benefit in the future?” said Holly Taylor, M.P.H, Ph.D., Assistant Professor at Johns Hopkins’ Department of Health Policy and Management. “There needs to be a justification … if you are to go forward with a trial.”

Michael R. Anderson, M.D., a member and Fellow of the American Academy of Pediatrics, said he believed the risk of inaction was great. “As a scientist and as a pediatrician, I look at the data from the military: they have given millions of doses (to adults) with excellent safety data. We have to figure out a cogent and safe way to figure out how to get the data with children.”

In January, Health and Human Services Secretary Kathleen Sebelius charged the Commission for ethical advice on the development of medical countermeasures for children. Her task was prompted by the question of finding out whether an anthrax vaccine was safe to give children. The National Biodefense Science Board had recommended doing the test, but only after ethical considerations were reviewed.

Under questioning from the Commission, the experts today estimated that a short trial of roughly 300 children would be needed to get an early sense at whether the vaccine was safe at specific doses to specific age groups of children. Those short trials, they said, might be followed by a broader safety study of around 1,000 children.

After three panel discussions and during a roundtable round-up, Commission member Raju Kucherlapati, Ph.D., the Paul C. Cabot Professor in the Harvard Medical School Department of Genetics, asked each of them whether they would vote to allow the anthrax trials for children to go ahead.

The vote: four no, three yes, and one who wouldn’t say.

Several said they did not have enough facts to support the trial. And some said the lack of knowledge meant that a trial was necessary.

“I want to know more about the relevant facts,” David DeGrazia, Ph.D., Professor of Philosophy at George Washington University, saying he wouldn’t support it yet.

Anderson, who supports the trial, said the lack of facts would hurt a future response: “If God forbid, D.C. is dusted today (with anthrax), we (adults) have .5 milligrams (of the vaccine) go into our arms. The six-year-old down at the day care center we have no idea what to give.”

Earlier, in one of the panel discussions, Dr. Lisa Kaplowitz from the Office of the Assistant Secretary for Preparedness and Response at HHS said the risks involved in a public health emergency go well beyond the likelihood of an event.

While there are clear ethical considerations related to the clinical testing of countermeasures that may never be needed—since it is impossible to know with certainty the likelihood of a specific event actually occurring—there is also a risk related to delays in action, she said.

For example, during a public health emergency, the goal is to “limit the chaos” and mobilize quickly to get treatments to a large number of people in a short period of time, Kaplowitz explained. Delays can result in illness and death.

Taking up the discussion of risks, Taylor urged the Commission to consider the consequences of not conducting trials for medical countermeasures.

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Biodefense board’s anthrax vote ‘wasn’t easy’ Thu, 17 May 2012 17:34:08 +0000 The chairman of the National Biodefense Science Board said today while his panel voted in favor of testing children with an anthrax vaccine prior to any anthrax threat, it also wanted a second opinion: an ethical review of doing the test.

“We wrestled with giving a vaccine to children (that was) untested,” said John S. Parker, M.D., Major General (Retired), and chair of the board. “We wanted to reduce the unknown risk to children in a pre-event, scientifically controlled situation.”

Parker told the Presidential Commission for the Study of Bioethical Issues that “respectable members of the public do not believe in the threat (and) do not believe that vaccines are effective … but it’s clear to me that the facts speak louder. If there is an anthrax release, … we must strive to have the same degree of surety of the vaccine’s safety in children as it is in adults.”

The anthrax vaccine is known to be safe in adults. More than 10 million doses have been given to 1.2 million people – most of them in the U.S. military – with no major side effects. But there have been no studies on whether the vaccine is safe with children.

Parker said tests are needed to answer that question. “If we are as a nation exposed to a weapon of mass destruction, (that) will include children,” he said, adding that in one doomsday modeling of an attack, “7.2 million people were exposed to anthrax spores and 25 percent of those were children.”

Bioethics Commission Chair Amy Gutmann, President of the University of Pennsylvania, asked Parker: “Your board strongly supported having safety trials for a children’s vaccine, correct?”

Parker said one member dissented, resulting in a 12-1 vote. “This wasn’t easy,” he said. “Up until this particular task, we always had unanimous votes.”

Gutmann also asked Parker whether the trial with children for an anthrax vaccine would seek volunteers of parents who wanted their children to participate.

“We have talked with first responders, with families in the Special Forces, there are groups out there that would want their families protected as much as they are protected,” Parker said. “ … That doesn’t say that these people have any obligations that they would be first-comers to be volunteers. But there are numbers in our population that would like their family involved.”

Parker said that he also favored testing children prior to any attack with the anthrax vaccine because many adults had significant soreness after receiving the shots.

“With anthrax, the injection goes from local redness and tenderness to severe redness and tenderness, malaise, and a few people have had fever. A lot more people have complained about anthrax injection than the flu shot.”

He continued: “I was immunized and although I didn’t return to a doctor to say it hurt, but it hurt. I had reaction. And I knew why. I don’t know how a child at age two will react to that.”

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Sebelius: Ethical considerations critical in protecting children Thu, 17 May 2012 16:25:49 +0000 Health and Human Services Secretary Kathleen Sebelius told the Presidential Commission for the Study of Bioethical Issues today that its consideration of ethical issues around protecting children in the event of a terrorist attack or a pandemic scare was critically important, calling children’s safety “our highest priority.”

Sebelius asked the Commission early this year for ethical advice on the development of medical countermeasures for children. The issue that sparked the broad charge from Sebelius was on how to treat children who have been exposed to anthrax, which was first raised during a Homeland Security exercise.

Sebelius said soon after starting in her job in 2009 she called for a review of the department’s entire medical countermeasures system to check on preparedness for a terror attack, a large-scale disaster, or pandemic. That review was sparked by the outbreak of the H1N1 influenza pandemic. The Department of Health and Human Services is responsible for developing and stockpiling safe and effective medical countermeasures to protect the nation.

“I learned very quickly some of the difficult issues on medical countermeasures,” she said. “And while we have made some progress toward these goals for adults, the development of appropriate medical countermeasures for children has been slower.”

She continued: “That’s due in part to the challenges we face in collecting appropriate scientific information about pediatric populations. We know we have got to address this particular problem. But we have to do it thoughtfully and carefully, with our children’s safety as our highest priority.”

Sebelius said she needed scientific evidence and she also needed experts to look at “all the costs and benefits, risk and opportunities, and then proceed in a way that reflects our values as a nation.”

“We are relying on you, the President’s Bioethics Commission, which has delivered rational, independent, evidence-based advice on a wide range of complex bioethical issues. And I know I can look forward to receiving the same, when it comes to countermeasures for children,” she said.

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Gutmann defines inquiry: Ethics on research with children Thu, 17 May 2012 13:11:44 +0000 The issue of how to protect children in the event of a terrorist attack or other large-scale disaster has received some coverage in the media. But rarely discussed is a full airing of the ethical issues around such protection.

Dr. Amy Gutmann, President of the University of Pennsylvania and Chair of the Presidential Commission for the Study of Bioethical Issues, opened the Commission’s meeting Thursday in Washington to define the parameters of the discussion.

The National Biodefense Science Board, she noted, has recommend that US Health and Human Services “move forward with such a study before a public health emergency occurs,” Gutmann said. “It also recommended that such testing occur only after the ethical considerations are adequately addressed and reviewed. That is what we are going to do – carefully and transparently review the ethical considerations surrounding the development of medical countermeasures for children. “

Gutmann talked about the Commission’s past studies involving human subjects’ research, but she said this inquiry was more specific: clinical trials of medical countermeasures with children.

“It is important that we are clear about the scope of our charge upfront,” she said. “We are not reviewing the ethics of vaccine research and use. Rather, our charge is to focus on medical countermeasures, and the special considerations that arise in testing them for pediatric use. Of course, some vaccines are also medical countermeasures, but so are other products, like antibiotics and antivirals. I want to be sure we keep this in mind throughout our deliberations.”

Among the speakers to appear before the Commission today: HHS Secretary Kathleen Sebelius and John S. Parker, M.D., Chair of the National Biodefense Science Board.

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Live from Washington Thu, 17 May 2012 10:16:20 +0000 Welcome to coverage of the Presidential Commission for the Study of Bioethical Issues today in Washington, D.C.

The topics today will include issues surrounding how the country should best prepare to protect children in the event of a terrorist attack or other large-scale disaster.

Guest speakers include Health and Human Services Secretary Kathleen Sebelius, who on Jan. 10 asked the Commission for ethical advice on the development of medical countermeasures for children. The Commission, in an afternoon session, also will continue its inquiry into privacy issues raised by low-cost whole genome sequencing.

Please follow the blog throughout the day for updates. Also, you can follow the proceedings live on a Webcast. You can find the link at

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A discussion on the ethics of neuroscience Fri, 03 Feb 2012 20:35:20 +0000 In the ethics surrounding neuroscience, an initial question considered by the Presidential Commission for the Study of Bioethical Issues today was the definition of the words “self” and “person.”

The subject of neuroscience is one of three that the Commission is taking up this year. The other two are whole genome sequencing and effective countermeasures to protect children.

The discussion also delved into developments in neuroscience; the use of those tools; the rights of a person; and what happens in situations such as when a person suffers a brain injury or descends into dementia.

“We know when someone suffers a brain injury, or has Alzheimer’s Disease, we’re quick to say they have become a different person,” said James Wagner, the Commission Vice-Chair and the President of Emory University. “It may not be clear what we mean by that, or what we know about that, so in light of that we want to understand words like person and self.”

John Perry, Distinguished Professor of Philosophy at the University of California, Riverside, Emeritus Professor of Philosophy at Stanford, and co-host of “Philosophy Talk,” a radio program that “questions everything… except your intelligence,” said it was important to demystify the definition of self.

“It’s a fairly straightforward concept,” he said. “Self is just a way of talking about ourselves.”

He continued: “What we know about ourselves, or think about ourselves isn’t just limited to the special ways people have to know about themselves. For example, this morning, trying to figure out where I should come to the meeting, I looked at the Commission Website and … part of that was seeing my name. ‘Ah this is where I should be.’ You have a John Perry concept., and I have a John Perry concept that is different than from my self concept.”

Marya Schechtman, Professor of Philosophy at the University of Illinois at Chicago, and author of The Constitution of Selves, talked about the identity of a person revolving around their narrative.

A narrative, she said, is a story of how people view themselves. “Lives are full of happenstance and trivia as well as important events, and they are part of our narrative as well,” she said.

Dr. Bernard Lo, Professor of Medicine and Director of Program in Medical Ethics at University of California, San Francisco, turned the discussion toward “change in self” and what that meant in real-life situations faced by patients, families and doctors.

He told the story of his favorite aunt who developed dementia in old age. She had told him years earlier that if she faltered badly in her later years she did not want to be kept alive. He said when he visited her during her period of dementia, she remembered him and his son and “was smiling.” Then she contracted pneumonia. The question, he said, was whether her contentment should override her earlier conviction not to prolong her life if any complications developed.

“To put this in ethical terms, what do you do when priority directions contradict current best interests?” Lo said.

Anthony Wagner, Professor of Psychology and Neuroscience at Stanford University, described new advances in neuroscience. Some involved the use of functional MRI (fMRI). He said some initial conclusions from studies showed that fMRIs can detect whether someone is remembering an episode “with reasonable high accuracy.”
He also said that in some cases, fMRI tests in patients in “vegetative states” have shown detection of brain responses to questions.
Those developments, Commission members said, meant that it may be time to consider ethical questions around the use of neuroimaging before the technology progresses further.

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Experts give top concerns on genetic tests Fri, 03 Feb 2012 02:33:15 +0000 In the final session today before the Presidential Commission for the Study of Bioethical Issues, Chair Dr. Amy Gutmann asked all the experts who presented information to talk about their greatest concern with genetic tests.

Gutmann, the President of the University of Pennsylvania, told them: “The Commission is very likely to focus its report on issues of privacy broadly construed. Anything that is relevant to privacy would be of great interest to the Commission.”

Among the responses:

Jane Kaye, Director of the Centre for Law, Health and Emerging Technologies at Oxford University: “I would say I see the whole genome sequencing is another twist on things happening already on science. … What we need to do is make (privacy concerns) more nuanced and allow individuals to say how whole genomes are used.”

George Annas, Chair of Health Law, Bioethics & Human Rights at Boston University School of Public Health: “This is fundamentally a reductionist (perspective), but the more we look at genes, the less we will look at the whole person and take the whole person into account.”

Pilar Ossorio, Associate Professor of Law and Bioethics at the University of Wisconsin-Madison: “We have used anonymity as a way to protect research participants from harm , and we are not taking seriously the fact we really are having decreasing amounts of anonymity and decreasing ability to provide that to people.”

Melissa Mourges, Assistant District Attorney and Chief of the Forensic Sciences/Cold Cases Unit in the New York County District Attorney’s office: “Knowledge is power and I would hate to give up the knowledge you can gain from this project. I think we figured out how to do it with the forensics database and we are ruthlessly, smart people and we need to figure out a way to get it done.”

Daniel Masys, Affiliate Professor of Biomedical and Health Informatics at the University of Washington School of Medicine: “The genome will tell the book of humanity, and as it is, we only understand one third of the words. … My major concern is that privacy not materially inhibit the ability to decode that book and understand what that means.”

Retta Beery, mother of twins who benefited from improved diagnosis through whole genome sequencing: “I agree that information is a good thing, and it is a good thing that can be used in diagnosing rare diseases, and it is something that should be shared in a broader format.”

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A positive use of genetic data: Justice Fri, 03 Feb 2012 01:14:40 +0000 After a morning that dealt in large part with privacy concerns in the use of genetic data, the Presidential Commission for the Study of Bioethical Issues heard another side of the issue: The data can lead to justice.

Melissa Mourges shows the DNA profile of a suspect.

Melissa Mourges, Assistant District Attorney and Chief of the Forensic Sciences/Cold Cases Unit in the New York County District Attorney’s office, described how DNA data has been invaluable.

With DNA profiles, Mourges said, “we can get cold hits matching a suspect to a crime. … For instance, we can learn a rape from California and a rape in Oklahoma are done by the same guy.”

She also said that authorities have kept tight restrictions on how the data has been used. Her comments followed other participants who raised questions about whether authorities could protect the privacy of an individual’s genomic sequencing.

Mourges said the Combined DNA Index System (CODIS), which are forensic databases maintained by all 50 states and the FBI, keeps DNA profiles of all known offenders. She said the system doesn’t allow for identification of a suspect until there’s a match in a case.

“We are never moving back with this technology,” she said, referring to law enforcement’s use of DNA data. “We have evidence who proves who done it, and not beyond a reasonable doubt, but beyond all doubt.”

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Ethical questions around genetic testing Thu, 02 Feb 2012 23:07:36 +0000 Just 10 years ago, a complete personalized genome test cost $3 billion. Some groups say that this cost could drop to as low as $1000 this year.

With the tests becoming more affordable, and more and more people getting whole genome sequencing tests, a host of related ethical issues are getting more attention, experts told the Presidential Commission for the Study of Bioethical Issues today in San Francisco.

Among them: Who will interpret this genetic data? Is it ethical to allow health care providers to interpret the data without a health systems infrastructure to help them interpret it? What will be the privacy protections to people who have the testing? Are privacy issues around genetic testing any different from other personal health information?

The Commission heard differing views on the thicket of ethical issues surrounding the emerging field.

First, though, it heard from an expert who tried to put the field in perspective.

“Our ability to acquire person-specific DNA data far exceeds our understanding of this information,” said Dr. Daniel Masys, Affiliate Professor of Biomedical and Health Informatics at the University of Washington School of Medicine. “… Genomics is the poster child for complexity in health care.”

Said Masys: “The Marcus Welby model that doctor knows everything and can do it right is hopelessly inadequate” for deciphering the intricacies of whole genome sequencing.

“This is on a scale of science that we’ve never seen before,” he said, adding later that in order to detect extremely rare diseases, scientists may need to look at a “group of 10,000 people, or even a million people” to detect genetic mutations in a handful of people.

Commission Chair Dr. Amy Gutmann, President of the University of Pennsylvania, said she was concerned about the public’s lack of understanding around genetic testing.

“There are snake oil salesmen out there for everything, and if you go on the Web you will likely find all kinds of offers” or claims about the benefits of genetic testing, Gutmann said. “As a president of a university, I believe in not only getting more knowledge, but getting it out there to the public. But to what extent, given that science takes time to develop, is there any concern about the amount of misinformation out there?”

Dr. Richard Gibbs, Director of the Human Genome Sequencing Center at the Baylor College of Medicine, agreed with Gutmann that misinformation was an issue.

“The slow pace of discovery that can transform lives is dramatically affecting … the distribution of this data. That is a vastly higher risk than someone who may foolishly sign onto a snake oil saleman. I come from another (perspective).”

Gutmann persisted, “People get harmed and sometimes killed by malpractice. You can’t just brush it away.”

“Absolutely,” Gibbs said. “There’s tension here. But the danger of not knowing is also a risk.”

In a second panel, George Annas, Chair of Health Law, Bioethics & Human Rights at the Boston University School of Public Health, argued that the results of genetic testing were “uniquely private” and that any use of that information for research should be closely controlled.
“The most important part of genetic information is individual to you,” Annas said. “It’s the way you look at your life. You can look at your genome as your future diary. No one should open that diary without your consent.”

Mark Rothstein, the Herbert F. Boehl Chair in Health Law and Medicine at University of Louisville School of Medicine, said that privacy concerns were just one of numerous issues around genetic testing.

Among those concerns, he said, were whether people should have to opt in to a study using genetic information or whether they had to specifically say they wanted to opt out of it.

“If you test it, sequence it, the results will be used,” Rothstein said. “The only questions are how broadly and for what purposes, what consequences? Will genomic information replace Social Security numbers? Will we become a society of the worried well?”

He continued: “And will genomic information increase health inequality? At the very least, genomic information will likely be used in ways we can’t predict now.”

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