Eric M. Meslin, Ph.D., Director of the IU Center for Bioethics and Associate Dean for Bioethics IUSM, has been appointed to the Institute of Medicine’s Committee on Drug Safety and Post-Marketing Requirements by IOM President Harvey Feinberg. The Committee has been asked by the FDA to evaluate the scientific and ethical issues involved in conducting studies of the safety of approved drugs. Questions to be explored by the committee include:
1. What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?
2. What are the strengths and weaknesses of various approaches, including observational studies, including patient registries, meta-analyses, including patient-level data meta-analyses, and randomized controlled trials, to generate evidence about safety questions?
3. Considering the speed, cost, and value of studies, what types of follow-up studies are appropriate to investigate different kinds of signals (detected pre-approval or post-marketing) and in what temporal order?
4. Under what circumstances should head-to-head randomized clinical trials for safety be required?
5. How should FDA factor in different kinds of safety evidence in considering different kinds of regulatory actions?
The Committee is charged with reporting its findings in March 2011. Complete information including the IOM Committee roster is available at: http://www.iom.edu/Activities/Quality/DrugSafetyPostMarket.aspx
Indiana University Center for Bioethics director Eric Meslin recently
Those pictured from left are Dr. Eric Meslin, Dr. Fiona Stanley, U.S. Consul General Dr. Ken Chern, and Dr. Lyn Beazley. Source: Reception in Honor of Dr. Eric Meslin, Perth — 12 May 2009. 2009 Public Affairs Programs, Consulate General of the United States - Perth, Australia.
returned from his trip to Australia. While adding to our growing collaborations with researchers and ethicists in Australia, Eric served as Visiting Professor-at-Large at the University of Western Australia. Recently, the IU Center for Bioethics, the Indiana CTSI, and the Indiana University School of Medicine, were pleased to welcome Lynette Fernandes from the UWA School of Medicine and Pharmacology, Pharmacology and Anaesthesiology Unit. During her visit, Dr. Fernandes exchanged ideas and compared notes on our institutions’ responsible conduct of research training programs.
Beating swine flu. Karen Dearne, Australian IT. May 26, 2009
e-Health ‘could take fight to swine flu’. Sky News, May 31, 2009.
Visiting professor brings bioethical discussion to Perth. Laura Glitsos, ScienceNetwork Western Australia. 2 June 2009.
If you’re interested in the ethical issues of international research, be sure to read Helsinki discords: FDA, ethics, and international drug trials. This is a recent commentary co-authored by IUCB’s Eric M. Meslin. The full text is free (with registration) and a brief excerpt has been posted that this CiteULike account.
Kimmelman J, Weijer C, Meslin EM. Helsinki discords: FDA, ethics, and international drug trials. Lancet. 2009 Jan 3;373(9657):13-4. PMID: 19121708
Many of you may already have learned of the recent death of Dr. Jay Katz. For those who were not aware, here is a link to the PRIM&R website which contains several memorial tributes.
It is difficult to put into words the impact that Katz had on the field of bioethics generally, and research ethics in particular. It is not a statement of hyperbole that he established the field of research ethics, both through his initial membership on the Tuskegee Study ad hoc panel in 1972, his later membership on the Advisory Committee on Human Radiation Experiment in 1995, and his groundbreaking volume Experimentation Involving Human Beings. His list of accomplishments extends far beyond these scholarly and advisory pursuits of course. He literally gave a voice, a philosophy, and a gravitas to this area of human endeavor. His work on informed consent famously described in his book The Silent World of Doctor and Patient provided one of the first systematic treatments of the subject of informed consent—and should perhaps be required reading for all clinicians, not just doctors.
For researchers who bemoan the perceived regulatory ‘burdens’ of submitting protocols to IRBs, for university administrators who worry about site visits and compliance, for companies that struggle with how best to design studies to test new drugs or devices, for students and trainees who are required to take courses or tests to demonstrate competency in research ethics—these worries pale in comparison to the worries that initially motivated Katz: the threat of potential harm to human beings involved in an activity that was not primarily in their best interest.
Perhaps on this day of national thanksgiving, all of us who work in health care and the life sciences and who care about the moral dimensions of what we do, we will give thanks for the life of Jay Katz. — Eric M. Meslin, Ph.D.
On October 7, 2008 Eric Meslin, PhD, was one of the lead debaters discussing six hot topics relevant to the progress of Europe’s biotechnology sector. The EuroBio House of Commons Debates are conducted with “all the pomp, deference and carnage of the British politics”. EuroBio 2008 was billed as “THE Life Sciences Event of the European Union Presidency”. The event was held at the Palais des Congrès conference centre in Paris, France.