Panel: Attacks on Syria’s Medical Personnel and Facilities

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There is a need for more data to help people pick amongst the multitude of treatment choices available today. For example, the fact that a man diagnosed with prostate cancer is made to select somewhat arbitrarily from either surgery, chemotherapy or monitoring, when millions of patients before him have already decided on one of these treatment options, is “remarkable,” says report coauthor Nancy Kass, deputy director for public health at the Johns Hopkins Berman Institute of Bioethics in Baltimore. If healthcare institutions had collected outcome data for each patient, doctors might have learned that one approach was most successful.

Several European countries and Canada make use of clinical data, even without asking for consent from patients, according to Sean Tunis, president of the Center for Medical Technology Policy in Baltimore and a study coauthor. More countries have been starting to do randomized trials in a clinical setting, he says, citing a study conducted primarily in Argentina that examined how a second opinion might reduce rates of Caesarean sections (Lancet 363, 1934–1940, 2004).

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Wednesday, September 19, 6:00 – 8:30 PM

Chevy Chase Auditorium, Johns Hopkins Hospital Zayed Tower 2119A

Panel Discussion Will Follow  |  Free  |  Open to all  |  Dinner Provided

Ruth Faden, PhD, MPH
Philip Franklin Wagley Professor of Biomedical Ethics; Director, Johns Hopkins Berman Institute of Bioethics

Matt Heineman
Producer/Co-Director, Escape Fire: The Fight to Rescue American Healthcare

Shannon Brownlee
Author, Overtreated: Why Too Much Medicine Is Making Us Sicker and Poorer

David Hellmann, MD
Chairman, Department of Medicine; Vice Dean, Johns Hopkins Bayview Medical Center

Moderator:
Jeffrey Kahn, PhD, MPH
Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy; Deputy Director for Policy and Administration, Johns Hopkins Berman Institute of Bioethics

RSVP via the Facebook Event Page

For More Information, Contact: Howard Choi (AMSA Johns Hopkins Chapter)
Link to Trailer/Official Movie Website

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Berman Institute media contact:
Leah Ramsay
lramsay@jhu.edu, 202.642.9640

Washington, DC—The Safeguarding Health in Conflict coalition commends the World Health Assembly—the governing body of the World Health Organization (WHO)—on its unprecedented step to protect the lives of health workers and patients in humanitarian crises by spearheading global efforts to document the number of attacks on medical services.

In violent conflicts, where health needs are most urgent, health workers are at risk of assault, arrest and sometimes kidnapping and death, compromising their ability to deliver care and remain on the job. But such attacks usually go unreported; with a body of evidence, the global community can better protect fragile health systems and those on the frontlines. “Systematic data collection will be the basis for developing prevention strategies and holding perpetrators accountable,” said Maurice I. Middleberg, vice president for global policy at IntraHealth International.

The Safeguarding Health in Conflict coalition urged passage of the new World Health Assembly resolution—requiring the WHO to lead international data collection of attacks on health workers, facilities, transports and patients—for more than a year, and on Friday, WHO member states at the 65th  World Health Assembly in Geneva adopted it.

“Health care services and the health workers who provide them are never more desperately needed, but never more vulnerable, than when violence convulses a society,” said Leonard Rubenstein, senior scholar at the Center for Public Health and Human Rights, Johns Hopkins Bloomberg School of Public Health and faculty, Johns Hopkins Berman Institute of Bioethics.

Numerous organizations joined coalition members in a statement encouraging the WHO member states to adopt the resolution so that the work of developing methods to collect data and report on attacks can commence. The statement was made on behalf of the World Health Professional Alliance, which includes the World Medical Association, International Council of Nurses, International Pharmaceutical Federation, World Confederation for Physical Therapy and World Dental Federation, and the statement was supported by the American Public Health Association, CARE, Center for Public Health and Human Rights at the John Hopkins Bloomberg School of Public Health, Doctors for Human Rights, International Health Protection Initiative, International Federation of Health and Human Rights Organisations, International Medical Corps, International Rehabilitation Council for Torture Victims, International Rescue Committee, IntraHealth International, Management Sciences for Health, Medact, Merlin, Physicians for Human Rights, Women’s Refugee Commission and World Federation of Public Health Associations. Going forward, the coalition will advocate for effective implementation of the World Health Assembly resolution.

The Safeguarding Health in Conflict coalition promotes respect for international humanitarian and human rights laws that relate to the safety and security of health facilities, workers, ambulances and patients during periods of armed conflict or civil violence. Founding members include IntraHealth International, Center for Public Health and Human Rights at the Johns Hopkins Bloomberg School of Public Health, Doctors for Human Rights, International Council of Nurses, International Health Protection Initiative, Karen Human Rights Group, Medact, Merlin – UK and Physicians for Human Rights.

Coalition contact: David Nelson, IntraHealth International, tel. 919-313-9139

“We used the Vision of Hope films to generate the content of curricula and spark discussions that are integral to pediatric palliative care training sessions for clinicians working with patients and families affected by chronic, life-limiting conditions,” says Gail Geller, ScD., MHS, who co-directed the Vision of Hope project with Cynda Rushton, Ph.D., R.N.  Both are core faculty members of the Berman Institute.

Living With Sickle Cell Disease: They Don’t Believe Me won the Houston festival’s Platinum Remi Award in the Medical/Health/Fitness/Wellness category.  Like all the short films in the Vision of Hope series, it is aimed at improving the quality of care and giving new hope to adolescents, young adults and families affected by chronic, life-threatening diseases by training their clinicians in the principles and practices of pediatric palliative care.

The film was produced in collaboration with Carlton Haywood, Jr., Ph.D., M.A., and Mary Catherine Beach, M.D., M.P.H., core faculty members of the Berman Institute and research experts on the ethical issues surrounding Sickle Cell Disease treatment.  The film was also received a CINE Golden Eagle Award in 2011.

“Living with the pain and other serious medical complications of Sickle Cell Disease becomes even more frustrating and emotionally painful when healthcare providers don’t believe the patient’s reports of their pain experience,” says Haywood.  “This film sheds light on the impact of these added burdens on patients, and I think the awards it’s won highlight just how powerful and moving it is to hear about these experiences from the patients themselves.  We hope to use these patient voices as tools to enact lasting changes in the quality of the care delivered to people suffering from Sickle Cell Disease.”

Another of the Vision of Hope films, Living With Duchenne Muscular Dystrophy: Many Faces of Hope, was also honored by a CINE Golden Eagle, as well as a Gold Remi Award in Houston. A third film in the series, Living With Duchenne Muscular Dystrophy: An Uncertain Future, was honored by a Bronze Remi Award at the Houston festival and a Bronze Telly Award in 2011.

“What makes these palliative care training programs innovative is that they are experiential, interdisciplinary and relational,” Geller explains.  “Relational learning expands the notion of professional competence to encompass the moral realm of human relationships and experience.  The Vision of Hope videos provide a means to integrate the voices and experiences of patients and families throughout all aspects of the training,” Geller says.

The Vision of Hope documentaries were directed by Nigel Noble of Magic Lantern Media. For more information on the films and curricula, contact Gail Geller (ggeller@jhu.edu) or Cynda Rushton (crushton@son.jhu.edu ).

BI faculty members Nancy Kass, Sc.D., Jeremy Sugarman, M.D., M.P.H., and Holly Taylor, Ph.D., M.P.H., will lead the working group, which will bring together a broad array of investigators from across the university to collaborate on the bioethical and human rights issues of HIV and AIDS research and treatment.

In addition to this working group, the Center will have other transdisciplinary groups or “cores,” including one to address Baltimore’s HIV epidemic; Johns Hopkins University President Ronald Daniels has made investment and engagement in the Baltimore community a priority, saying in his installation address, “We are an island of earned privilege in a sea of pressing need.”

Other groups will focused on Viral Eradication, Substance Abuse, international research and training the next generation of AIDS researchers and biostatisticians, particularly underrepresented minority investigators.  Read more at the Johns Hopkins Bloomberg School of Public Health.

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One of the key recommendations made by the report, Ethical and Scientific Issues in Studying the Safety of Approved Drugs, is that upon approval, each drug have a single, comprehensive, publicly available Benefit and Risk Assessment and Management Plan (BRAMP) to serve as a central, updateable repository of side effects and other information.

“A drug’s full range of risks and benefits become apparent after it is used widely over time, and so it is crucial that the FDA continue to monitor drugs throughout their market life-cycle with a systematic and transparent process,” says committee co-chair Ruth Faden, Ph.D., MPH, director of the Johns Hopkins Berman Institute of Bioethics.

According to the committee, the BRAMP should include a description and benefit – risk assessment of any safety questions that exist when a drug is approved, as well as any that emerge over the course of its market life-cycle, with details on any regulatory actions taken and their results.

The FDA—which asked the IOM to “convene a committee to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs”—already collects much of the suggested information, but the data are scattered across multiple records rather than amassed in one central location. “Decentralized records make it difficult for physicians, policy makers and consumers to easily assess information about risks and benefits that accrue over time,” Faden notes.

The committee recommends postmarket studies when:

• A regulatory decision cannot be made based on existing safety evidence
• The research can be designed and implemented to sufficiently reduce uncertainties about the benefit-risk balance and help inform a regulatory decision
• The results of the research will be used to make a decision in a timely fashion
• The rights and interests of the research participants can be adequately protected

Another key recommendation in the report addresses the significant ethical issues posed by postmarket monitoring. The committee recommends that the FDA establish a new body to provide advice on the ethical challenges that required observational studies and surveillance activities pose.

The report also makes recommendations about how postmarket research should be conducted. The committee found that while randomized controlled trials remain the gold standard for studying drug effectiveness, observational studies have ethical and practical benefits over clinical trials once drugs are on the market. Results can be obtained more quickly, and thus regulatory action can be taken earlier.

The committee’s recommendations build on the FDA’s increased authority through the 2007 Food and Drug Administration Amendments Act to monitor drugs after approval and to act if there are signals of safety issues, Faden notes.

“Our report focuses on how the agency can be proactive, so that when a drug’s risk outweighs its benefit, the FDA will know earlier and respond quickly, while honoring its ethical obligations to protect both public health and research participants,” says Faden.

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Contact: Leah Ramsay
lramsay@jhu.edu
202-642-9640
Johns Hopkins Medical Institutions

A professor with the Berman Institute and the Johns Hopkins Bloomberg School of Public Health since August 2011, Kahn previously was Director and Professor in the Center for Bioethics at the University of Minnesota, positions he held from 1996-2011.He serves on numerous state and federal advisory panels, including his role as chair of an Institute of Medicine committee that issued a recent, groundbreaking report calling for an end to most biomedical research on chimpanzees, which was immediately adopted by the National Institutes of Health upon its release. Kahn is also an elected Fellow of the Hastings Center and was founding president of the Association of Bioethics Program Directors, a position he held from 2006-2010.

Robert Henry Levi and Ryda Hecht Levi were great supporters of Johns Hopkins University, Baltimore City, and the arts. The Robert. H. Levi Leadership Program in Bioethics and Health Policy was established in 1997.

The endowed professorship traces a long history of royal and private support for academia, including the famous privately endowed Lucasian Chair of Mathematics at Cambridge University, bestowed on Issac Newton in 1669, and later on Professor Stephen Hawking. The endowment of the Levi professorship will ensure the Berman Institute of Bioethics will always be home to a leading mind in the field of bioethics and public policy.