Dan Klotz – blog.Bioethics.gov https://bioethicsarchive.georgetown.edu/pcsbi/blog 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 Roundtable Discussion on Medical Countermeasures for Children https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/02/roundtable-discussion-on-medical-countermeasures-for-children/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/02/roundtable-discussion-on-medical-countermeasures-for-children/#respond Thu, 02 Aug 2012 20:51:37 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=364 The Presidential Commission for the Study of Bioethical Issues has been examining the ethical considerations of conducting clinical trials of medical countermeasures for children. The Commission’s report will explore whether to conduct a pre- and post-event study of an anthrax vaccine as a component of treatment for children exposed to weaponized anthrax.

At today’s meeting, the Commission discussed the ins and outs of research involving children, vulnerable populations and the threat of bio-terror attacks; some of the comments include:

David Resnik, J.D., Ph.D., Bioethicist and IRB Chair, National Institute for Environmental Health Sciences: “What is the social benefit of the research, what is the probability of a terrorist attack, and what is the potential impact? Would there even be a public health benefit if there’s not an adequate supply of countermeasures in place?”

Richard Gorman, M.D., Associate Director for Clinical Research, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases: “Neurontin was used for chronic pain in adults. When we started using it in children it was not effective. The clinical results came back and we had to use it at the same level as adults… We don’t know what we don’t know until we look to see what we can find.”

Neal Halsey, M.D., Professor of International Health, Johns Hopkins Bloomberg School of Public Health: “During the anthrax exposures that took place ten years ago, people didn’t know how long you had to treat people with antibiotics. The thought now is, if you had the vaccine and if someone was exposed you could start the vaccine at the same time so you could eventually end the antibiotics.”

The Commission spent some time considering how to recruit families and who might volunteer for a pediatric anthrax vaccine trial:

Nelson Michael, M.D., Ph.D., Commission member and Director of the U.S. Military HIV Research Program at the Walter Reed Army Institute of Research: “Military personnel are considered a vulnerable population, end of discussion. However, I don’t think it will be ethically and intrinsically wrong for military members to be included if they chose to.”

Anita Allen, J.D., Ph.D., Commission member and Henry R. Silverman Professor of Law at the University of Pennsylvania: “Military families are subject to extraordinary pressures on the need to conform and obey; military children are disproportionately separated from their families… Maybe military families are not the best place to go for experimentation.”

Alexander G. Garza, M.D., M.P.H., Commission member and Assistant Secretary for Health Affairs and Chief Medical Officer for the Department of Homeland Security: “After having received the anthrax and smallpox vaccine I can still walk and chew gum at the same time. That being said, we’re talking about two different worlds when we talk about vaccines for influenza and for anthrax. We know a lot about the influenza virus. We don’t know a lot about the anthrax vaccine.”

John Arras, Commission member and Porterfield Professor of Biomedical Ethics at the University of Virginia: “I’m reminded in this context of Hans Jonas’s famous article where he argues that research subjects are best recruited if they are most knowledgeable about the subject and most enthusiastic. We may want to look for volunteers at CDC, NIH, and Ft Detrick.”

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Risk and Minimal Risk: How Low Can You Go? https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/02/risk-and-minimal-risk-how-low-can-you-go/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/02/risk-and-minimal-risk-how-low-can-you-go/#respond Thu, 02 Aug 2012 18:47:53 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=361

David Wendler, Ph.D.

David Wendler leads the Vulnerable Populations Unit in the National Institutes of Health Clinical Center’s Bioethics Department. In a conversation ranging from child soldiers to high school car washes, he led the Presidential Commission for the Study of Bioethical Issues through an exploration of minimal risk and societal benefit that will help inform the Commission’s deliberations on medical counter-measures for children.

Wendler has literally written the book on the ethics of pediatric research (published by Oxford University Press) and has published numerous academic papers on the subject.

“When is it acceptable to have children in an activity with risk that is designed to benefit others?” Wendler asked the Commission.

Wendler then expanded on the definition of minimal risk, providing data on risk levels. The risk of death in everyday activities is 3 per million; disability, 40 per million; broken bones, 300 per million. Moving above these levels to test an anthrax vaccine for children, he noted, depends on how you define the benefit.

Commission Member Daniel P. Sulmasy, M.D., Ph.D., Franciscan Friar, and the associate director of the MacLean Center for Clinical Medical Ethics at the University of Chicago, asked Wendler to look at children as a category of vulnerable population. “Does it matter in the moral analysis when the benefits of the research help this category?”

“But what is their group?” Wendler asked in response. “You can define children in so many ways, by age, ethnicity, height and weight. Essentially, you shouldn’t be doing this on people who don’t understand what you are doing unless you have to.”

Dr. Amy Gutmann, Commission Chair and President of the University of Pennsylvania, asked about a pair of public research polls discussing situations in which children take physical risks above the norms.

“We accept the idea of children taking on risk for the benefit of their siblings,” she pointed out. “And we dislike the idea of child soldiers, where children take risks for the benefit of their country.”

Where, she pondered, does the testing of medical counter-measures for children fit in?

Wendler responded by examining the risk in car washes. “There are lots of schools,” he said, “Where they take 10 to 17 year-old kids and they’re standing by the highway with a big sign and they’re collecting money for hurricane victims. These risks are downplayed.”

Wendler then posed a separate question to the Commission. “You’ve got someone in serious trouble, you’ve got someone drowning, you’ve broken your leg and can’t go, would you send your 14 year-old in?”

The answer always depends, he pointed out. “The chances that the project will succeed are tremendously important.”

“There are very few moments in life when children can make a difference that adults cannot. This might be another situation,” he concluded, “Adults can’t be the final test subject of a vaccine for children.”

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Dryvax, individual risk and the greater good https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/02/dryvax-individual-risk-and-the-greater-good/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/02/dryvax-individual-risk-and-the-greater-good/#respond Thu, 02 Aug 2012 17:36:07 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=357 How do you balance the individual risk of testing an anthrax vaccine for children against the societal good of having the vaccine on hand in case of an anthrax terrorist attack?

This morning, the Presidential Commission for the Study of Bioethical Issues explored how researchers tackled this ethical dilemma in 2002. Months after 9/11, worried about the threat of a smallpox terrorist attack, members of the Internal Review Board at Harbor-University of California at Los Angeles (Harbor-UCLA) Medical Center looked at whether to test a diluted form of the vaccine Dryvax to protect children. Production of Dryvax had ended and supplies had dwindled. Harbor-UCLA staff wanted to see if diluting the vaccine (which would extend the available supply) was a safe and effective way of addressing the threat of a smallpox attack for children. An earlier study determined that using a diluted vaccine was safe in adults.

Neal Halsey, M.D., Professor of International Health and the Johns Hopkins Bloomberg School of Public Health, reviewed the history of the pediatric study of the Dryvax vaccine for the Commission. The Pediatric Rule, he noted, is that you must study vaccines and drugs in children when there is anticipated use. “But,” he said, “In these situations, how do you estimate this use?”

David Resnik, J.D., Ph.D., Bioethicist and IRB Chair for the National Institute for Environmental Health Sciences, discussed the concept of minimal risk and the National Institutes of Health’s definition: as a probability and magnitude of harm not greater than that encountered in daily life. But he added that applying this definition was difficult in practice; even the act of drawing blood was not universally recognized as meeting minimal risk standards.

Commission member John Arras, of the University of Virginia, discussed how the Commission has received conflicting information on whether testing an anthrax vaccine for children represented a minimal risk.

Halsey replied that “There’s a zone that exists between somewhat greater than minimal risk and the risk posed by the smallpox vaccine. There is no adequate gradation that comes into play. Until the vaccines have been studied and studied widely, you don’t know the risk.”

Ruth Berkelman, M.D., Rollins Professor and Director of the Emory University Center for Public Health Preparedness and Research, explained to the Commission that both societal and individual risk must be considered.

“Protecting the public health is an essential government responsibility,” she said. “Public health is used to dealing with scant data. But there is a huge difference between minimal data and no data. In the absence of data, the government’s response can be confused.”

In the case of Dryvax, which had potentially severe complications, the debate on whether to begin studying the safety of a diluted vaccine in clinical trials with children lasted until early 2003 when the Secretary of Health and Human Services and Food and Drug Administration Commissioner agreed to end the initiative.

“Bioterrorism preparedness plans have evolved such that, under current plans, the potential to use diluted Dryvax in children will no longer exist,” the two officials said in a joint statement.

All participants in this morning’s conversation acknowledged that the smallpox vaccine presented serious health risks. But the risks posed by the anthrax vaccine to children proved harder to define, and in the end, the Dryvax story did not offer a bright line of where to balance the risk.

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Wrapping up Genomics and Privacy https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/02/wrapping-up-genomics-and-privacy/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/02/wrapping-up-genomics-and-privacy/#respond Thu, 02 Aug 2012 15:11:32 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=349 The Presidential Commission for the Study of Bioethical Issues wrapped up its public deliberations on genomics and privacy this morning, ending a more than year long examination of the emergence of whole genome sequencing as an addition to clinical care and genetic research. The Commission spent several hours publicly discussing the set of recommendations it intends to deliver to President Obama.

“The Commission’s recommendations,” said Dr. Amy Gutmann, Commission Chair and President of the University of Pennsylvania, “clump into two big categories, one is consent to whole genome sequencing and to the possible findings and how they will be treated, and the other is oversight.”

One question that was explored in depth was, as Commission member John Arras, Ph.D., of the University of Virginia, put it, “the impending merger between clinical practice and research,” and how that would impact informed consent.

Commission member Raju Kucherlapati, Ph.D., from the Harvard Medical School Department of Genetics, said, “Genetic testing for research purposes involves extensive informed consent forms signed by individuals, while the process of consent for clinical testing is not as extensive a process.”

Members discussed at length the informed consent issue of “opting in” versus “opting out.” “Opting in” is giving patients the option of joining a research study.  “Opting out” means informing patients that they are assumed to be participating in a research study unless they choose not to.

“We want the public good to be served,” Gutmann asserted at several points, with Commission recommendations helping the science move forward.  She suggested the Commission also strongly recommend that the federal government should be encouraged to facilitate access to the broadest number of people possible.

The Commission also discussed expanding the amount of deliberation it requires to make a solid set of recommendations surrounding the issue of incidental findings. That is, when a researcher or clinician finds a result other than what they set out to discover and how to handle that information—if a geneticist looking for the genetic marker for one disease also notices the genetic marker for another.

The Commission is expected to deliver a report to President Obama in the fall.

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Do privacy concerns follow the coffee cup? https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/01/do-privacy-concerns-follow-the-coffee-cup/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/01/do-privacy-concerns-follow-the-coffee-cup/#respond Wed, 01 Aug 2012 19:13:38 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=342

Is there privacy in everyday items?

As the Presidential Commission for the Study of Bioethical Issues continued its review of genomics and privacy, the group heard from experts on genomic database security, one from the private sector and one from the federal government.

Ken Chahine, Ph.D., is the Senior Vice President of Ancestry.com and General Manager of AncestryDNA, two related companies that take great pains to maintain data confidentiality and security. The data collection processes of the two companies are designed with privacy first in mind, even down to the collection kit that strives to preserve the anonymity of their customers.

Laura Lyman Rodriguez, Ph.D., is the director of Policy, Communication and Education at the National Human Genome Research Institute at the National Institutes of Health (NIH). She oversees how the NIH collects study participant data, implements privacy safeguards and data security measures, and then transparently shares this data with researchers—in that the inquiries themselves are not hidden from the public—while protecting data and privacy.

But Chahine pointed out that DNA is anything but secure. “Why would someone hack our servers to access my data when you could follow me to a coffee shop and grab a sample from my used coffee cup?”

Chair Dr. Gutman immediately zeroed in on the coffee cup. “Here’s the important point that it makes,” she responded. “The questions of personal privacy and genome sequencing do not boil down to ownership. I cannot own what I leave behind.”

Vice Chair James Wagner, Ph.D., inquired about the degree that data use and data access can be separated.

“In my world,” responded Rodriguez, “They are very much tied together. If the access is not provided in appropriate ways, it constrains the kinds of questions that can be asked.”

Access is important, Chahine stated. “There’s research that’s important that researchers are not tackling. The more access that we can give, the more we would be moving forward.”

A critical point on privacy would appear to be the limits on removing identifying characteristics from genomic data so that researchers could use the data without touching on privacy concerns. When asked by an audience member on the permanency of making personal data anonymous, Rodriguez did not consider ‘de-identification’ as absolute.

“We should operate under the assumption,” Chahine added, “that if ‘re-identification’ is not possible now it will be in the future.”

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On the Frontiers of Technology and Privacy https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/01/on-the-frontiers-of-technology-and-privacy/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/01/on-the-frontiers-of-technology-and-privacy/#respond Wed, 01 Aug 2012 19:07:30 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=334

Latanya Sweeney, Ph.D.

Latanya Sweeney, Ph.D., director and founder of Harvard University’s Data Privacy Lab, has made a career of weaving technology and policy together. Her presentation today provided real-world examples in the realm of consumer data privacy that helped the Commission continue its examination of genomics and privacy.

Sweeney’s exploration of how medical data is handled—mapping out how patient files were widely shared among not just health care providers but also researchers, for-profit companies, and even transcription companies—was widely publicized and one of many works that had a profound impact on U.S. policy. She has appeared in hundreds of news articles and has written numerous academic papers not only on how technology challenges privacy, but how technology can also save privacy. Her work was cited in the original publication of the HIPAA Privacy Rule and has been applauded by consumer advocacy groups; her privacy technologies have been licensed by numerous companies.

“There is no doubt that technology shapes our expectations of privacy,” Sweeney told the Commission. “In fact technology shapes much of how we’re likely to talk about privacy today, and that’s not surprising. What might surprise is that we can craft new technology to shape how society will think of privacy as we go forward.”

In her career as a computer science professor, she fully embraced the public policy impacts of her role in society.

“As a computer science professor I have trained hundreds of young minds,” she recounted. “Most recently I realized that these young computer scientists and computer entrepreneurs are actually policy makers, able to make architectural decisions about technology that dictate real world practice and societal norms.”

She noted that her students have never been trained for this role, underscoring the importance of the Commission’s work.

Sweeney looks at what happened with the 2001 Superbowl in Tampa Bay, Florida, and understands what the Commission’s review of genomic privacy can avoid. “Law Enforcement used facial recognition software to enhance security,” she said. “But this created a public outcry that would have threatened research funding if 9/11 hadn’t intervened. The terrorist attack provided a rationale to continue this research.”

“Disruptions will happen and any of them can explode. Any of these can hit the front page of the New York Times and then Congress will respond,” she concluded. “The Commission’s role in this issue is to get out ahead of the disruptions. Otherwise if one data set has consequences, all data sets are disrupted.”

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Assessing the Life-Saving Potential and Privacy Implications of Whole Genome Sequencing https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/01/assessing-the-life-saving-potential-and-privacy-implications-of-whole-genome-sequencing/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/01/assessing-the-life-saving-potential-and-privacy-implications-of-whole-genome-sequencing/#respond Wed, 01 Aug 2012 13:10:51 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=329 As researchers develop faster and less expensive methods of whole genome sequencing—the process in which a person’s DNA is decoded and analyzed—the potential to quickly diagnose current and future diseases has become tantalizingly close. But privacy concerns have emerged as the technology becomes more widespread.

For scientists to make life-saving discoveries, individuals must be willing to share their personal genomic data and trust that their data will be protected. But what exactly should those protections encompass? How should the information gathered through whole genome sequencing be collected, used, and governed?

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 Wednesday in Washington with an overview of how this issue has been tackled so far.

“We began our work on this project last year, and many experts, stakeholders, and members of the public have enriched our deliberations,” noted Dr. Gutmann. “This is the fourth meeting at which we have addressed this project. We have also reached out to 18 federal agencies to learn about their relevant practices and policies, and they have been very forthcoming in their responses. And, we have received extensive and thoughtful public comment.”

This is the last meeting in which the Commission will consider this issue before releasing its report on genomics and privacy in fall 2012.

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Live from Washington https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/01/live-from-washington-2/ https://bioethicsarchive.georgetown.edu/pcsbi/blog/2012/08/01/live-from-washington-2/#respond Wed, 01 Aug 2012 12:40:18 +0000 https://bioethicsarchive.georgetown.edu/pcsbi/blog/?p=322 Welcome to coverage of the Presidential Commission for the Study of Bioethical Issues, which is meeting today and tomorrow in Washington, D.C. (August 1-2, 2012).

This meeting will continue discussions on genomic privacy, which the Commission has been following since January 2011. At the heart of the Commission’s work on genomics is how to reconcile an individual’s need for privacy, consent, and respect with the need for gathering data from many individuals to advance discoveries that benefit the common good. The Commission expects to deliver a report on genomics and privacy in fall 2012.

The Commission will also continue exploring issues surrounding how the country should best prepare to protect children in the event of a terrorist attack or other large-scale disaster. The Commission is proceeding with a careful review of the ethical considerations of conducting clinical trials of medical countermeasures for children at the request of Health and Human Services Secretary Kathleen Sebelius.

Guest speakers include Latanya Sweeney, Ph.D. of Harvard University, David Resnik, J.D., Ph.D. of the U.S. National Institutes of Health, Neal Halsey, M.D. of the Johns Hopkins School of Medicine, and Ruth Berkelman, M.D. of Emory University.

Please follow the blog throughout today and tomorrow for updates. Also, you can follow the proceedings live on a Webcast: http://www.tvworldwide.com/events/bioethics/120801/

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