Johns Hopkins | Berman Institute of Bioethics

	Eliminating drug price differentials across government programmes in the USA
	Friday, February 05, 2010
	Health Economics, Policy and Law Published Online, February 4, 2010 Kalipso Chalkidou, Gerard F Anderson and Ruth Faden Federal agencies in the USA pay significantly different prices for the same prescription drugs because each agency uses a different approach to derive the payment rate. Because we do not identify any economic rationale or socially accepted moral reasoning that would justify the current level of price variation, we suggest that the federal government should pay a uniform price for each drug. Laws and regulations that give certain federal agencies the ability to earn rebates, use formularies, or permit other special arrangements would need to be eliminated in order to have a single payment rate. This could make some government agencies worse off than others; however, a uniform payment rate would not need to affect beneficiaries’ current financial contributions, access to drugs, benefits or overall public expenditures. At the same time, having a single rate would permit the government to adopt a more effective approach to purchasing drugs and send a consistent message to pharmaceutical companies concerning which types of drugs the government wants them to develop for government beneficiaries. How this single price would be derived and how it would compare with the lowest or highest prices currently achieved by government agencies would depend on a variety of policy issues including the government’s desire to encourage pharmaceutical research and development and the need to control health care spending. ...Read More

	Learning CURVES: An acronym for assessing patient decision-making capacity in emergencies
	Thursday, February 04, 2010
	Chow, G.V., Czarny, M.J., Hughes, M.T., Carrese, J.A. (2010). CURVES: A mnemonic for determining medical-decision making capacity and providing emergency treatment in the acute setting. CHEST, 137(2), 421-427. Feb. 4, 2010 - Physicians in training and bioethicists at Johns Hopkins have created an easy-to-remember checklist to help medical students and clinicians quickly assess a patient’s decision-making capacity in an emergency. A report on the acronym CURVES, and how to use it, will be published in the February issue of CHEST. CURVES stands for Choose and Communicate, Understand, Reason, Value, Emergency and Surrogate. Doctors and students easily memorize mnemonic devices, and applying this one will help them determine whether a patient is able to make decisions in emergency situations fraught with stress and uncertainty. The memory aid is designed to uphold the core bioethical principles of patient autonomy and assurance of benefit, says Joseph Carrese , M.D., director of the Program on Ethics in Clinical Practice at the Johns Hopkins Berman Institute of Bioethics. The gold standard, he said, is to inform the patient about treatment options, make recommendations when appropriate, and have the patient exercise free will in making treatment choices. But in life-or-death situations, because of severe pain or the illness itself, determining whether a patient has the capacity to engage in such decision-making can be extremely difficult. Carrese, a co-author of the paper, said the acronym is easy to learn and should help physicians render a clinical judgment about decision-making capacity during a critical event quicker than with assessment methods used for non-emergency situations. The evaluation device should also help practitioners with documenting emergency-medical decisions. “If you ask medical students, they can rattle off several dozen mnemonics that they’ve learned to help remember things and organize their thinking,” said Carrese, an associate professor at the Johns Hopkins School of Medicine. “Because it can be remembered and recalled under time pressure, then all the key elements are more likely to be considered and applied.” [For instance, one popular medical mnemonic is ABCD, which stands for the various treatment options for a heart attack: aspirin, beta blockers, clot busters and dynamite (nitrates).] The original idea for CURVES emerged during an educational conference for residents and medical students on clinical ethics led and taught by Carrese. At the conference, Grant Chow, M.D., an internal medicine resident at Johns Hopkins Bayview Medical Center, shared the dilemma he faced with two emergency patients. Chow then presented the acronym to Carrese, and the two, along with medical student Matthew Czarny and Assistant Professor of Medicine Mark Hughes, M.D., demonstrated the mental checklist in their paper via two challenging scenarios based on the cases Chow shared at the conference. In the first scenario, an 84-year-old woman with a history of severe, chronic obstructive pulmonary disease is showing symptoms that indicate her condition could soon kill her. She is told that she should be admitted and treated with noninvasive positive pressure ventilation, intubation or comfort care. Instead, she says, “I want to die at home. Please, let me go home.” In the second scenario, a morbidly obese, 53-year-old man is admitted for suspected obesity hypoventilation syndrome and obstructive sleep apnea. At one point, he passes out and stops breathing, but is soon resuscitated. His breathing remains weak, and his head begins to bob. A medical team prepares to intubate him to stabilize his breathing, but the patient blurts out, “I don’t want a tube! No tube!” The checklist reminds practitioners how to quickly assess each patient’s decision-making capacity, before acting on their own decision about which treatment option is in their patients’ best interests: C – Can the patient freely choose from among the different treatment options? Are they also able to communicate their preference, either verbally, in writing or through the use of signals? (The authors acknowledge that some persuasion by a physician might be appropriate here.) U – Does the patient understand the risks, benefits, alternatives and consequences of the various courses of action? R – Can the patient reason and provide adequate explanation for accepting or declining each intervention? V – Is the patient’s decision consistent with his or her value system? If the answers to any of those questions are no, or are unclear, Carrese said it is highly unlikely that a patient has adequate decision-making capacity. The doctor can then act on his or her own clinical judgment after confirming two last criteria, which, according to CURVES, are: E – Is it a true emergency, with serious or imminent risk to life or limb? If so, then decisions need to be made quickly. S – Is there a surrogate decision-maker or legal document immediately available that details the patient’s wishes? If there isn’t, and if there is no time for an ethics consultation, then it’s up to the doctor. Following the CURVES process, the physicians let the elderly woman go home. The second patient was intubated. Carrese cautions that CURVES doesn’t diminish the role of clinical judgment. “The mnemonic will help you remember that you have to consider whether the patient is communicating their choice,” he said. “But it won’t tell you whether they’re doing it to an acceptable degree, or adequately.” The work was funded by the Morton K. and Jane Blaustein Foundation, and by the office of Ronald Peterson, president of Johns Hopkins Health System and executive vice president of Johns Hopkins Medicine. More information: Abstract: http://chestjournal.chestpubs.org/content/137/2/421 Program on Ethics in Clinical Practice: http://www.bioethicsinstitute.org/web/page/637/sectionid/377/pagelevel/2/interior.asp Media Contact: Michael Pena 410-625-7872 ; mpena@jhsph.edu

	Reasoning through rationing of end-of-life care
	Tuesday, January 19, 2010
	Acknowledging that the idea of rationing health care, particularly at the end of life, may incite too much vitriol to get much rational consideration, a Johns Hopkins emeritus professor of neurology called for the start of a discussion anyway, with an opinion piece featured in this month’s issue of the Journal of Medical Ethics. In the January article, John Freeman, M.D., Lederer Professor Emeritus of Pediatric Neurology and a faculty member of the Johns Hopkins Berman Institute of Bioethics, asks the Obama administration to consider rationing end-of-life care as an initial step towards healthcare reform. The piece, “Rights, Respect For Dignity And End-Of-Life Care: Time For A Change In The Concept Of Informed Consent,” starts with the premise that futile and expensive care at the end of life is widespread, that it has been a major contributor to the increasingly unaffordable cost of healthcare and that the nation is unable to provide it equitably to all. He goes on to say that while administering such care—as ordered through a living will, next of kin or parent—should be respected, he advocates that the ethical imperatives of “patient autonomy” and “surrogate autonomy” (passing responsibility for decision-making to next of kin when a patient no longer is competent to make his own decisions) should be weighed against the societal impact and costs of such care in futile circumstances. “Perhaps when surrogate autonomy and the ethical principles of beneficence”—the duty to do more good than harm—“compete with the utilitarian principle of doing the greatest good for society, the family be given a ‘nudge’ towards comfort care only,” Freeman suggests in the piece. “There must be few situations more undignified, more dehumanizing or more humiliating than lying in bed, incontinent, tube fed, with or without a respirator, unable to speak or to relate to individuals or the environment,” Freeman says—factors that more surrogates may want to give more weight. Rationing and providing only comfort care should be considered not just at the end of life for adults, Freeman maintains, but also in instances of extremely premature births. He cites studies showing that intensive care for infants born at 22 to 23 weeks resulted in more than 1,700 extra days in intensive care, with less than 20 percent surviving. Of those 20 percent, less than 3 percent survived without profound impairment that required expensive interventions. For more information: Article: “Rights, Respect For Dignity And End-Of-Life Care: Time For A Change In The Concept Of Informed Consent" Bio: http://www.bioethicsinstitute.org/mshome/?id=72 Media Contact: Michael Pena 410-625-7872; mpena@jhsph.edu

	Denying care to illegal immigrants raises ethical concerns
	Monday, January 04, 2010
	Kaiser Health News, December 31, 2009 By Ruth Faden, Director, Johns Hopkins Berman Institute of Bioethics The Senate’s Christmas Eve vote makes historic legislation to transform our health care system likely. Politicians, who rightly note that this legislation would affect nearly all Americans, could also point out that the people least affected may not be Americans at all, but those in the country illegally. Under the House bill, illegal immigrants could buy coverage in the bill’s insurance exchange but would be ineligible for federal subsidies; under the Senate version, even that would not be not permitted. The implications are staggering. While the Senate bill would extend insurance coverage to 31 million people, the Congressional Budget Office projects that as many as 23 million people would still be uninsured in 2019, about 8 million of whom would be illegal immigrants. We don’t need to wait until 2019, however, to witness the human tragedies and policy nightmares at the heart of health care for undocumented immigrants. The closing of the outpatient dialysis unit at Grady Memorial Hospital in October 2009 captures it all. Grady Memorial, a public hospital and fixture in Atlanta for over 100 years, provides care to the poor and essential services to the whole community, including a Level 1 trauma center and ambulance fleet. It has been seriously in the red for over a decade. Major steps have been taken recently to keep Grady’s doors open, most controversially the decision to close the outpatient dialysis unit. At the time of the decision, the unit, which was using outdated equipment that needed to be replaced, was losing between $2 million and $4 million annually. Two-thirds of its then remaining patients were undocumented immigrants. When the dialysis unit finally closed, there were about 50 patients left, almost all undocumented. That undocumented immigrants were left behind is hardly surprising. End stage renal disease is the one and only area of medicine where most Americans already have guaranteed coverage. The Social Security Amendment of 1972 ensures access to kidney dialysis, but applies only to U.S. citizens. Another law requires hospitals that receive federal funds to provide emergency care, including dialysis, to any patient regardless of immigration status who presents with a life-threatening condition. At the same time, special federal funds that are used to offset this emergency care cannot be used to provide illegal immigrants with "maintenance dialysis"—regular dialysis treatments that prevent the life-threatening complications of renal failure and keep patients out of emergency rooms. Against this incoherent federal backdrop, a few states fund maintenance dialysis for undocumented immigrants, but a majority, including Georgia, do not. Disagreements continue about whether closing the outpatient dialysis unit was necessary to save Grady Memorial, and about whether the hospital did everything it should have done to assist patients in finding maintenance dialysis care elsewhere. The hospital has offered to pay for private dialysis for up to one year and to help some patients return to their home countries for care there. ... ...Read More

	Communications specialist joins Berman Institute
	Monday, January 04, 2010
	Michael Pena has joined the Johns Hopkins Berman Institute of Bioethics to serve as its communications specialist and media-relations representative. He comes to Johns Hopkins from Stanford University News Service, where he spent the last five years writing articles featured in the university's printed news weekly for faculty and staff, as well as on its news Web site. He also held media relations responsibilities, writing press releases, working with journalists and assisting staff, faculty and administrators with external communications. Brought on as part of the Berman Institute's Rapid Response Initiative, Michael will serve as science writer and public information officer, providing timely background and news on issues in the ethics of health care, science and public health. His scope of work will include promotion of faculty experts and scholarly work affiliated with the institute via press releases, an e-newsletter, blog and social media. Before his career at Stanford, he worked as a reporter for the San Francisco Chronicle and other newspapers in the Northern California Bay Area. He is a graduate of San Francisco State University, where he studied journalism.

	"We'll do this together": the role of the first person plural in fostering partnership in patient-physician relationships
	Saturday, January 02, 2010
	Helen Kinsman, Debra Roter, Gail Berkenblit, Somnath Saha, P. Todd Korthuis, Ira Wilson, Susan Eggly, Andrea Sankar, Victoria Sharp, Jonathon Cohn, Richard D. Moore and Mary Catherine Beach Journal of General Internal Medicine, Published Online: December 22, 2009 Abstract Background Partnership is integral to therapeutic relationships, yet few studies have examined partnership-fostering communication behaviors in the clinic setting. We conducted this study to better understand how statements in which physicians use the first person plural might foster partnership between patient and provider. Methods We audio-recorded encounters between 45 HIV providers and 418 patients in the Enhancing Communication and HIV Outcomes (ECHO) Study. We used the Roter Interaction Analysis System (RIAS) to code for statements made by the physician that used the first person plural to refer to themselves and their patient. Using multiple logistic regression, we examined the associations between the occurrence of one or more first person plural statements with patient ratings of provider communication. To better understand the meaning of first person plural statements, we conducted a qualitative analysis. Main Results Providers were mostly white (69%) and Asian (24%); 57% were female. Patients were black (60%), white (25%), and Hispanic (15%); 33% were female. One or more first person plural statements occurred in 92/418 (22%) of encounters. In adjusted analyses, encounters with first person plural statements were associated with younger patient age (OR 0.97, 95% CI 0.94–0.99), higher patient depression scores (highest tertile compared to lowest tertile: OR 1.89, 95% CI 1.01–3.51), the patient not being on anti-retroviral therapy (OR 0.53, 95% CI 0.29–0.93), and older provider age (OR 1.05, 95% CI 1.00–1.09). After adjustment, patients were less likely to highly rate their provider’s communication style if first person plural statements were used (AOR 0.57, 95% CI 0.33–0.96). There were 167 first person plural statements made by physicians in the 418 encounters. Qualitative analysis revealed that many first person plural features had at least one negative feature such as being overtly persuasive (“That’s going to be our goal”), indirect (“What can we do to improve your diet?”), or ambiguous (“Let’s see what we can do”), although there were also positive statements that involved patients in the health-care process, contributed to a mutual understanding, and addressed the patients’ goals. Conclusions Contrary to our hypotheses, use of first person plural was not associated with higher ratings of provider communication, probably because some of these statements were overtly persuasive, indirect, or ambiguous. Physicians should become aware of benefits and pitfalls of using the first person plural with patients. Further research is needed to determine the most effective methods through which providers can build alliances with patients. ...Read More

	Ancillary Care in Community-Based Public Health Intervention Research
	Saturday, December 19, 2009
	Ancillary Care in Community-Based Public Health Intervention Research American Journal of Public Health, December 17, 2009 Maria Merritt, Holly Taylor, Luke Mullany Community-based public health intervention research in developing countries typically takes place not in clinics but in people's homes and other living spaces. Research subjects and their communities may lack adequate nutrition, clean water, sanitation, and basic preventive and therapeutic services. Researchers often encounter unmet health needs in their interactions with individual subjects and need ethical guidelines to help them decide how to respond. To what extent do researchers have an ethical obligation to provide ancillary care-health care beyond what is necessary to ensure scientific validity and subjects' safety? We discuss a case example from Nepal and propose a simple 2-step sequence of questions to aid decision making.

	Making Access to Flu Vaccine Happen
	Friday, December 18, 2009
	Dr. Orin Levine: Making Access to Flu Vaccine Happen Huffington Post, December 18, 2009 This week in an Op-Ed for the San Francisco Chronicle, my colleagues Ruth Karron, Ruth Faden, and I urged the US government to move quickly on their pledges to donate vaccine for developing countries in this pandemic season. Our call seems to have been heard as there is much activity in the US government to make this happen. The call now is for more details and specifics and especially for making sure its done right this time and in a way that is sustainable in the future. One specific issue has come up around the pricing of the vaccine for the donation. Basically, if the vaccine is being purchased for the poorest populations of the world shouldn't it be priced accordingly - in other words, at prices that would be affordable for those countries not just the USA. The argument for this is pretty simple: If there is a fixed amount of money and you want to make it as impactful as possible then lower prices are important to this global justice outcome. There are some practical counter-arguments to this philosophically unimpeachable starting point. The most important of these is that there is only a limited volume of vaccine supply to be purchased so the theoretical 'savings' by having a lower price would not translate into more doses of the vaccine because there just aren't any more doses of the vaccine. Also, while this pandemic response had to be organized quickly and may not have allowed much planning, the long-term answer to sustainable vaccine access for developing countries is one that structures procurement and pricing to make it affordable to those countries (and their donor partners) for the future. This is an important critique and one that must be acknowledged, even in the rush to fix things this year. So, here's a proposal that may address the issues raised here in a way that meets all the main issues and each stakeholder's needs. First, industry and government should structure their pricing and procurement contracts so that any doses that are intended for donation to poorer countries are priced accordingly - i.e., at significantly reduced prices. Second, the US government should dedicate at least half of the 'savings' (that is the lower price for donated doses subtracted from the US general population price) to alternative pandemic control uses. Examples would be using the funds to build antibiotic or antiviral stockpiles, funding the GAVI Alliance to buy pneumococcal vaccines, or supporting CDC disease surveillance and detection programs that would otherwise go unfunded. ... ...Read More

	U.S. should give away H1N1 swine flu vaccine
	Wednesday, December 16, 2009
	San Francisco Chronicle: Open Forum, December 16, 2009 Ruth A. Karron, Orin S. Levine, Ruth R. Faden In June, the World Health Organization confirmed that a new influenza pandemic was upon us. The United States and other wealthy countries supported a nearly unprecedented effort to develop, test and license H1N1 influenza vaccines, and give their own citizens nearly exclusive access to these vaccines as quickly as possible. Delays in manufacture meant that in October and November, many in these countries had to wait their turn while limited supplies were given to those at greatest risk. December is already very different. In the United States, the number of new H1N1 cases is steadily decreasing, while the vaccine supply increases. In the first week of December, we saw an increase of 13 million doses over the previous week, and our supply has roughly doubled over the past month, with more than 76 million doses of vaccine shipped for distribution. Soon, everyone in the United States who wants the vaccine will have it, and there will be more on hand. How should this extra vaccine be used? There is still a global shortage, because it is estimated that 3 billion doses of H1N1 could be produced over the next year, enough to immunize only half the world's population. The Netherlands has already put its excess supply up for sale. Should the United States follow suit? Along with at least eight other countries, the United States pledged to give 10 percent of its national supply to low-income countries, and manufacturers promised more as well. But at best, these donations would vaccinate less than 10 percent of the population in 95 of the world's poorest countries, leaving unprotected many of those at highest risk from H1N1. And as of this writing, many of these promised doses have yet to be donated to the WHO. In August, Dr. Tachi Yamada of the Bill and Melinda Gates Foundation called on rich countries to donate H1N1 vaccine to poor countries for use "in the same time frame as vaccines for developed nations." People living in low-income countries are particularly vulnerable. Their health care systems are already overtaxed by the existing levels of disease. H1N1 and the bacterial infections that often follow will add to the already high burden of pneumonia among the world's poor. We recommend that the U.S. government and the governments of other wealthy countries immediately donate 10 percent of their H1N1 vaccine supply for the poorest countries, and state publicly when the donations will begin. Many developed countries can and should give more. They should make these donations as soon as possible to provide the greatest benefit. ... ...Read More

	Expensive Cancer Drugs
	Monday, December 14, 2009
	Expensive cancer drugs: a comparison between the United States and the United Kingdom Ruth R. Faden, Kalipso Chalkidou, John Appleby, Hugh R. Waters and Jonathon P. Leider Milbank Quarterly, 87(4): 789-819 Abstract: Context: This article compares the United Kingdom's and the United States' experiences with expensive cancer drugs to illustrate the challenges posed by new, extremely costly, medical technologies. Methods: This article describes British and American coverage, access, and cost-sharing policies with regard to expensive cancer drugs and then compares the costs of eleven such drugs to British patients, American Medicare beneficiaries, and American patients purchasing the drugs in the retail market. Three questions posed by these comparisons are then examined: First, which system is fairer? In which system are cancer patients better off? Assuming that no system can sustainably provide to everyone at least some expensive cancer drugs for some clinical indications, what challenges does each system face in making these difficult determinations? Findings: In both the British and American health care systems, not all patients who might benefit from or desire access to expensive cancer drugs have access to them. The popular characterization of the United States, where all cancer drugs are available for all to access as and when needed, and that of the British NHS, where top-down population rationing poses insurmountable obstacles to British patients' access, are far from the reality in both countries. Conclusions: Key elements of the British system are fairer than the American system, and the British system is better structured to deal with difficult decisions about expensive end-of-life cancer drugs. Both systems face common ethical, financial, organizational, and priority-setting challenges in making these decisions. ...Read More

Lancet retracts 'utterly false' MMR paper

guardian.co.uk, February 2, 2010

By Sarah Boseley

MMR doctor andrew wakefield misconduct case

The Lancet today finally retracted the paper that sparked a crisis in MMR vaccination across the UK, following the General Medical Council's decision that its lead author, Andrew Wakefield, had been dishonest.

The medical journal's editor, Richard Horton, told the Guardian today that he realised as soon as he read the GMC findings that the paper, published in February 1998, had to be retracted. "It was utterly clear, without any ambiguity at all, that the statements in the paper were utterly false," he said. "I feel I was deceived."

Many in the scientific and medical community have been pressing for the paper, linking the MMR (measles, mumps and rubella) jab to bowel disease and autism, to be quashed. But Horton said he did not have the evidence to do so before the end of the GMC investigation last Thursday.

In 2004, when concerns were first raised about the conduct of the study, the Lancet asked the Royal Free hospital, where Wakefield and his fellow authors worked, to investigate. But Professor Humphrey Hodgson, then vice-dean of the Royal Free and University College school of medicine, wrote to the journal to say it had found no problems. "We are entirely satisfied that the investigations performed on children reported in the Lancet paper had been subjected to appropriate and rigorous ethical scrutiny," he said at that time.

The GMC last week disagreed. Children had been subjected to invasive procedures that were not warranted, a disciplinary panel ruled. They had undergone lumbar punctures and other tests solely for research purposes and without valid ethical approval. ...Read More

co-sleeping toddler from theattachedparent.com

Picture of Health Blog, Baltimore Sun, December 22, 2009
There are lots of assumptions made about the U.S. health care system and how it differs from say, the British nationalized model. In America, everyone has unfettered access to top-notch drugs, while the Brits ration their care, goes the stereotypes. That leads many critics of U.S. health reform efforts to assume the American system is just fine the way it is.

But a new study by Johns Hopkins researchers finds the perceptions aren't so. The study compares the two systems' access to the most expensive cancer medications and asks: Which is more fair? And which cancer patients are better off?

The study, appearing in Milbank Quarterly, compared the costs of 11 pricey cancer drugs. In the UK, seven are free to all patients, with no out-of-pocket costs. Four aren't because they aren't considered worth the limited benefit. If patients want those drugs, they need to pay up.

Here at home, people with insurance have some coverage of all 11 drugs--but the range of out of pocket costs are enormous, depending on the carrier.

Both systems involve a kind of rationing, concludes the study. And here's something that will make reform foes gasp: The issue isn't whether rationing is good or bad, argues the reports' author, Ruth R. Faden, director of the Johns Hopkins Berman Institute for Bioethics. That's because no system can provide patients every medication or intervention to every patient all the time, she writes.

"The issue is what we should do about extraordinarily expensive treatments, some of which do very little to improve how well or how long people live," said Faden in a statement. At the same time, she adds, "there is no ethically defensible reason why some Americans have access to expensive cancer drugs and some do not."

New York Times, December 22, 2009

LOS ANGELES — The Ronald Reagan U.C.L.A. Medical Center, one of the nation’s most highly regarded academic hospitals, has earned a reputation as a place where doctors will go to virtually any length and expense to try to save a patient’s life.

“If you come into this hospital, we’re not going to let you die,” said Dr. David T. Feinberg, the hospital system’s chief executive.

Yet that ethos has made the medical center a prime target for critics in the Obama administration and elsewhere who talk about how much money the nation wastes on needless tests and futile procedures. They like to note that U.C.L.A. is perennially near the top of widely cited data, compiled by researchers at Dartmouth, ranking medical centers that spend the most on end-of-life care but seem to have no better results than hospitals spending much less.

Listening to the critics, Dr. J. Thomas Rosenthal, the chief medical officer of the U.C.L.A. Health System, says his hospital has started re-examining its high-intensity approach to medicine. But the more U.C.L.A.’s doctors study the issue, the more they recognize a difficult truth: It can be hard, sometimes impossible, to know which critically ill patients will benefit and which will not.

That distinction tends to get lost in the Dartmouth end-of-life analysis, which considers only the costs of treating patients who have died. Remarkably, it pays no attention to the ones who survive...

See also: Comment by Ruth Faden, Director, Johns Hopkins Berman Institute of Bioethics

Nature News, November 30, 2009

Five months after abruptly dismantling the bioethics advisory council left by his predecessor, US President Barack Obama last week created a new bioethics commission that will move beyond the issues that consumed previous panels, such as stem cells and cloning. Based within the Department of Health and Human Services, the Presidential Commission for the Study of Bioethical Issues is explicitly charged with recommending legislative and regulatory action and promises to have more influence on policy.

Bioethical, social and legal questions relating to genomics and behavioural research are all on the commission's agenda. So are issues of intellectual property, scientific integrity and conflicts of interest in research.

The contrast with the previous bioethics council established by President George W. Bush is stark. Bioethicist George Annas of Boston University, Massachusetts, has described that council, which existed in two incarnations, as having a "narrow, embryo-centric agenda", focusing largely on the research implications of questions such as the moral status of the embryo and when life begins (seeNature 431, 19–20; 2004).

In another break with the past, Obama has chosen not to appoint bioethicists to lead the commission. Instead, it will be chaired by political theorist Amy Gutmann, president of the University of Pennsylvania in Philadelphia, and its vice-chair will be materials scientist James Wagner, president of Emory University in Atlanta, Georgia.

Gutmann's work deals with deliberative democracy, and using reasoned argument to depolarize politics. Wagner served at the Food and Drug Administration's Center for Devices and Radiological Health for a decade, and now, as Emory's president, stresses that ethical engagement is integral to the university's strategic vision.

"The appointments of Gutmann and Wagner reinforce the expectation that this commission will seek to provide practical, actionable guidance to the administration and the country," says Ruth Faden, executive director of the Berman Institute of Bioethics at the Johns Hopkins University in Baltimore, Maryland. "This is a wise way to structure the leadership of the commission."...

The White House, Office of the Press Secretary, November 24, 2009

WASHINGTON – Today, President Barack Obama signed an Executive Order creating a new Presidential Commission for the Study of Bioethical Issues. He also announced today he has appointed Amy Gutmann to serve as Chair and James W. Wagner to serve as Vice Chair of the Commission.

President Obama said, “As our nation invests in science and innovation and pursues advances in biomedical research and health care, it’s imperative that we do so in a responsible manner. This new Commission will develop its recommendations through practical and policy-related analyses. I am confident that Amy and Jim will use their decades of experience in both ethics and science to guide the new Commission in this work, and I look forward to listening to their recommendations in the coming months and years.”

The President’s Commission for the Study of Bioethical Issues will advise the President on bioethical issues that may emerge from advances in biomedicine and related areas of science and technology. The Commission will work with the goal of identifying and promoting policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in an ethically responsible manner. The full Executive Order is attached.

President Obama also announced that he will appoint the following individuals to the Commission for the Study of Bioethical Issues:

Amy Gutmann, Chair, Presidential Commission for the Study of Bioethical Issues

Dr. Amy Gutmann – a distinguished political scientist, philosopher, and scholar of ethics and public policy – currently serves as president of the University of Pennsylvania. She is also the Christopher H. Browne Distinguished Professor of Political Science in the School of Arts and Sciences and holds secondary appointments in communications, education, and philosophy. Prior to her appointment as the University of Pennsylvania’s president in 2004, Dr. Gutmann served as Provost at Princeton University, where she was also the Laurance S. Rockefeller University Professor of Politics. At Princeton, she was the founding Director of the University Center for Human Values – a leading multi-disciplinary center that fosters greater research and discourse on ethics and human values. Dr. Gutmann has authored and edited 15 books and has published more than 100 articles, essays, and book chapters. She is a founding member of the Association of Practical and Professional Ethics, and serves on the Board of Directors of the Carnegie Corporation of New York, the Vanguard Corporation, and the Board of Trustees of the National Constitution Center. She received her B.A. magna cum laude from Harvard-Radcliffe College, M.Sc. from the London School of Economics, and Ph.D. from Harvard University.

James W. Wagner, Vice Chair, Presidential Commission for the Study of Bioethical Issues

James W. Wagner currently serves as the President of Emory University, where he has championed the role of ethics in the mission of the University by significantly enhancing the prominence of Emory’s university-wide Center for Ethics and including ethical engagement as one of the six pillars of the University’s strategic vision. Dr. Wagner previously served as Provost, University Vice President, and Interim President of Case Western Reserve University. Prior to that, he was Dean and Professor of Materials Science at the Case School of Engineering from 1998 to 2000. His academic career began at The Johns Hopkins University’s Whiting School of Engineering as Professor of Materials Science and Engineering with a secondary appointment in Biomedical Engineering. He ultimately chaired the Johns Hopkins Department of Materials Sciences and Engineering. Before becoming a professor, Dr. Wagner worked for nearly a decade as a researcher for the Food and Drug Administration Center for Devices and Radiological Health where he developed quality-assurance methods and performed failure analyses on medical devices. Dr. Wagner has authored more than 115 professional publications, and was elected a fellow of the American Academy of Arts and Sciences in 2009. He holds a B.A. in electrical engineering from the University of Delaware, an M.A. in clinical engineering from The Johns Hopkins University School of Medicine, and a Ph.D. in materials science and engineering from The Johns Hopkins University Whiting School of Engineering.

Chicago Tribune, November 23, 2009

Dr. Carlos Pardo was trying to head off trouble.

The Johns Hopkins neurologist and his colleagues had autopsied the brains of people with autism who died in accidents and found evidence of neuroinflammation. This rare look inside the autistic brain had the potential to increase understanding of the mysterious disorder.

It also, he knew, could inspire doctors aiming to help children recover from autism to develop new experimental treatments -- even though the research was so preliminary the scientists did not know whether the inflammation was good or bad, or even how it might relate to autism.

So when Pardo and his colleagues published their paper in the Annals of Neurology in 2005, they added an online primer that clearly explained their findings in layman's terms and sternly warned doctors not to use them to develop treatments.

"We were concerned that the study would raise a lot of controversy and be misused," Pardo said. "We were right."

Over and over, doctors in the autism recovery movement have used the paper to justify experimental treatments aimed at reducing neuroinflammation.

But the history of medicine is rife with treatments that physicians and overjoyed patients hailed as miracles but that, when tested in clinical trials, proved to be unsafe, worthless or both. Seeing is not always believing in medicine, in terms of both safety and effectiveness.

Few treatments are completely benign, said Dr. Steven Goodman of the Johns Hopkins Berman Institute of Bioethics. "Even an ineffective therapy is rarely harmless," he said, "and sometimes that harm is worse than the disease."

And the combination of pressure and oxygen can be disastrous. In May a hyperbaric oxygen chamber at a Florida clinic exploded in flames while a young boy with cerebral palsy and his grandmother were inside. The grandmother died quickly. The child, burned over the majority of his body, died in June...

Chicago Tribune, November 22, 2009

James Coman's son has an unusual skill. The 7-year-old, his father says, can swallow six pills at once.

Diagnosed with autism as a toddler, the Chicago boy had been placed on an intense regimen of supplements and medications aimed at treating the disorder.

Besides taking many pills, the boy was injected with vitamin B12 and received intravenous infusions of a drug used to leach mercury and other metals from the body. He took megadoses of vitamin C, a hormone and a drug that suppresses testosterone.

This complex treatment regimen -- documented in court records as part of a bitter custody battle between Coman, who opposes the therapies, and his wife -- may sound unusual, but it isn't.

Thousands of U.S. children undergo these therapies and many more at the urging of physicians who say they can successfully treat, or "recover," children with autism, a disorder most physicians and scientists say they cannot yet explain or cure.

But after reviewing thousands of pages of court documents and scientific studies and interviewing top researchers in the field, the Tribune found that many of these treatments amount to uncontrolled experiments on vulnerable children...

	Berman Institute faculty member in Haiti
	The Berman Institute's Daniel Finkelstein, M.D., professor of ophthalmology at the Johns Hopkins University School of Medicine, left on Friday, Feb. 5, to volunteer at a hospital in northern Haiti as part of a mission with the Order of Malta Federal Association. The Berman Institute will share updates from Finkelstein via its Facebook and Twitter pages. He returns on Saturday, Feb. 13. ... Read More

	Learning CURVES: An acronym for assessing patient decision-making capacity in emergencies
	Feb. 4, 2010 - Physicians in training and bioethicists at Johns Hopkins have created an easy-to-remember checklist to help medical students and clinicians quickly assess a patient’s decision-making capacity in an emergency. A report on the acronym CURVES, and how to use it, will be published in the February issue of CHEST. CURVES stands for Choose and Communicate, Understand, Reason, Value, Emergency and Surrogate. Doctors and students easily memorize mnemonic devices, and applying this one will help them determine whether a patient is able to make decisions in emergency situations fraught with stress and uncertainty. The memory aid is designed to uphold the core bioethical principles of patient autonomy and assurance of benefit, says Joseph Carrese , M.D., director of the Program on Ethics in Clinical Practice at the Johns Hopkins Berman Institute of Bioethics. The gold standard, he said, is to inform the patient about treatment options, make recommendations when appropriate, and have the patient exercise free will in making treatment choices. But in life-or-death situations, because of severe pain or the illness itself, determining whether a patient has the capacity to engage in such decision-making can be extremely difficult.... ...Read More Abstract: http://chestjournal.chestpubs.org/content/137/2/421 Program on Ethics in Clinical Practice: http://www.bioethicsinstitute.org/web/page/637/sectionid/377/pagelevel/2/interior.asp Media Contact: Michael Pena 410-625-7872 ; mpena@jhsph.edu

	Communications specialist joins Berman Institute
	Michael Pena has joined the Johns Hopkins Berman Institute of Bioethics to serve as its communications specialist and media-relations representative. He comes to Johns Hopkins from Stanford University News Service, where he spent the last five years writing articles featured in the university's printed news weekly for faculty and staff, as well as on its news Web site. He also held media relations responsibilities, writing press releases, working with journalists and assisting staff, faculty and administrators with external communications. Brought on as part of the Berman Institute's Rapid Response Initiative, Michael will serve as science writer and public information officer, providing timely background and news on issues in the ethics of health care, science and public health. His scope of work will include promotion of faculty experts and scholarly work affiliated with the institute via press releases, an e-newsletter, blog and social media. Before his career at Stanford, he worked as a reporter for the San Francisco Chronicle and other newspapers in the Northern California Bay Area. He is a graduate of San Francisco State University, where he studied journalism.

	Denying care to illegal immigrants raises ethical concerns
	Kaiser Health News, December 31, 2009 By Ruth Faden, Director, Johns Hopkins Berman Institute of Bioethics The Senate’s Christmas Eve vote makes historic legislation to transform our health care system likely. Politicians, who rightly note that this legislation would affect nearly all Americans, could also point out that the people least affected may not be Americans at all, but those in the country illegally. Under the House bill, illegal immigrants could buy coverage in the bill’s insurance exchange but would be ineligible for federal subsidies; under the Senate version, even that would not be not permitted. The implications are staggering. While the Senate bill would extend insurance coverage to 31 million people, the Congressional Budget Office projects that as many as 23 million people would still be uninsured in 2019, about 8 million of whom would be illegal immigrants. We don’t need to wait until 2019, however, to witness the human tragedies and policy nightmares at the heart of health care for undocumented immigrants. The closing of the outpatient dialysis unit at Grady Memorial Hospital in October 2009 captures it all. Grady Memorial, a public hospital and fixture in Atlanta for over 100 years, provides care to the poor and essential services to the whole community, including a Level 1 trauma center and ambulance fleet. It has been seriously in the red for over a decade. Major steps have been taken recently to keep Grady’s doors open, most controversially the decision to close the outpatient dialysis unit. At the time of the decision, the unit, which was using outdated equipment that needed to be replaced, was losing between $2 million and $4 million annually. Two-thirds of its then remaining patients were undocumented immigrants. When the dialysis unit finally closed, there were about 50 patients left, almost all undocumented. That undocumented immigrants were left behind is hardly surprising. End stage renal disease is the one and only area of medicine where most Americans already have guaranteed coverage. The Social Security Amendment of 1972 ensures access to kidney dialysis, but applies only to U.S. citizens. Another law requires hospitals that receive federal funds to provide emergency care, including dialysis, to any patient regardless of immigration status who presents with a life-threatening condition. At the same time, special federal funds that are used to offset this emergency care cannot be used to provide illegal immigrants with "maintenance dialysis"—regular dialysis treatments that prevent the life-threatening complications of renal failure and keep patients out of emergency rooms. Against this incoherent federal backdrop, a few states fund maintenance dialysis for undocumented immigrants, but a majority, including Georgia, do not. Disagreements continue about whether closing the outpatient dialysis unit was necessary to save Grady Memorial, and about whether the hospital did everything it should have done to assist patients in finding maintenance dialysis care elsewhere. The hospital has offered to pay for private dialysis for up to one year and to help some patients return to their home countries for care there. ... ...Read More

	Monday, February 08, 2010
	Johns Hopkins Berman Institute of Bioethics Seminar Series 2/8/2010- 12:15pm - 1:30pm
	Empirically-informed Ethics Education in Post-Graduate Medical Training Mark Hughes, MD, MA Assistant Professor, Division of General Internal Medicine, Johns Hopkins University School of Medicine and Margaret Moon, MD, MPH Freeman Family Scholar in Clinical Medical Ethics; Assistant Professor, Division of Pediatrics and Adolescent Medicine, Johns Hopkins University School of Medicine Lunch will be provided For more information contact: mmartind@jhsph.edu

	Monday, February 22, 2010
	Johns Hopkins Berman Institute of Bioethics Seminar Series 2/22/2010- 12:15pm - 1:30pm
	Your Life, Your Choices: Foundation, Recent Challenges, Future Approach Your Life, Your Choices (YLYC) is a patient-centered workbook to facilitate advance care planning. It was developed in the mid-1990’s with extramural research funding, and was influenced by “right-to-die” concerns, research on patient preferences, and inadequacies in existing educational materials for patients and their families. In a recent review of YLYC material we recognized that some of the material had become outdated. In addition, due to heightened sensitivity to disability and pro-life perspectives, public fears of being denied end-of-life care have nearly eclipsed fears of receiving unwanted treatment. The presentation will review the history of Your Life, Your Choice’s development, recent challenges, and how it is being updated to be a state-of-the-art product in 2010. Robert Pearlman, MD, MPH Chief, Ethics Evaluation, Department of Veteran's Affairs Rives Hutzler Lecture Lunch will be provided For more information contact: mmartind@jhsph.edu

	Thursday, February 25, 2010
	The 28th David Barap Brin Lecture in Medical Ethics 2/25/2010- 4:30 pm - 6:00 pm
	Engaging the Public in Contentious Priority Setting WHERE: Albert H. Owens, Jr. Auditorium David H. Koch Cancer Research Building Cancer Research Building 2 (Johns Hopkins Medical Campus) SPEAKER: Marion Danis, M.D. Head, Section on Ethics and Health Policy and Chief, Bioethics Consultation Service Department of Bioethics Clinical Center National Institutes of Health Marion Danis is Chief of the Bioethics Consultation Service at the Clinical Center of the National Institutes of Health. She also heads the Section on Ethics and Health Policy in the Department of Clinical Bioethics at the Clinical Center. She moved to the NIH in 1997 after serving on the faculty of the Division of General Medicine and Clinical Epidemiology at the University of North Carolina where she practiced critical care and general internal medicine and served as a faculty member of the Robert Wood Johnson Clinical Scholars Program. She has chaired the ethics Committee for the Society of Critical Care Medicine. She currently chairs the International Society on Priorities in Health Care. Marion Danis received her BA and MD degrees at the University of Chicago. She completed a residency in Internal Medicine and a research fellowship at the University of North Carolina at Chapel Hill. She has had a long-standing interest in incorporating patient preferences into medical practice, the need to reduce health disparities, and the need to distribute limited medical resources fairly. She has conducted studies in end-of-life decision-making, advance directives, mechanisms for priority setting in medical care, and access to care for the uninsured. She is currently developing decision exercises to incorporate public opinion into health care priority setting. She has co-edited a volume entitled, Ethical Dimensions of Health Policy, published by Oxford University Press. For additional information, call Christina Dill at 410-955-8842