Adrian Gropper, MD is CTO of Patient Privacy Rights, a national organization representing 10.3 million patients. As an entrepreneur and physician-developer he has founded a number of software-intensive medical device companies. He has also participated in the creation of Blue Button, Direct Project, and Blue Button Plus, and is active in promoting open and patient-centered data policy. He holds an engineering degree from MIT and an MD from Harvard Medical School.
Declaration of Helsinki – 2013 Edition
Ladies and gentlemen, we have a newly revised Declaration of Helsinki, just announced today in a special online communication from JAMA. The revisions are accompanied by commentary from Paul Ndebele and Joe Millum, Dave Wendler, and Zeke Emanuel. Take a look.
Still no word on the ANPRM to the Common Rule, though…
Petrie-Flom Intern’s Weekly Round-Up: 10/12-10/18
By Fatima Mirza
- Given the recent end to the Government Shutdown, Obama’s Health Law may come under greater scrutiny, according to the Wall Street Journal. During the distraction, which lasted sixteen days, key events included the opening of the new online health-insurance exchanges and Republican attempts to defund the law.
- A group of politicians from the Council of Europe have signed a declaration denouncing “three-parent embryos” as eugenic. The UK currently has plans to legalize the practice.
- On Thursday, the World Health Organization added pollution to its official list of carcinogens. Though a global problem, people in developing countries with prominent manufacturing sectors are said to be particularly at risk.
- A Michigan medical marijuana patient could cost federal taxpayers more than $1.2 million. Tracy Duval claims that her husband is being denied adequate health care, and has introduced a dialogue about access and necessary procedures.
- A senior NHS representative said that mental health is still misaligned within the organization and huge gaps exist in the quality of services throughout the UK. The stigma can be found in the profession itself, the Guardian reported.
- Three decades of commercially-used mercury could be eliminated by a new global treaty said Achim Steiner, head of the U.N.’s environment agency. The Minamata Convention on Mercury focuses on the detrimental effects of the compound and its tendency to accumulate in fish, eventually working up the food chain.
- The World Health Organization recently approved a vaccine that will protect millions of children from Japanese encephalitis. The development signals China’s commitment to the global vaccine marketplace.
Yale Friday Newsletter
Today’s Friday newsletter has arrived from the Yale Interdisciplinary Center for Bioethics.
For prior issues of the newsletter, visit the Center’s website.
Unreliable Biomedical Science, and a Solution?
The Economist has a long, detailed, and readable piece about the difficulties of inferring anything from the published findings of biomedical science. There are all sorts of problems that fall short of scientific fraud, including the the biases caused by industry-funding of biomedical science, the biases of unblinded raters who see what they want to see, and the biases of journal editors towards only publishing “positive” findings. (I am particularly enamored with this graphic, which shows the fundamental problem of inference.) It is rare for researchers to even bother to attempt to replicate prior findings, but when replications are attempted, they often fail. 
The Economist piece can be read as something close to an outright assault on empiricism, at least as we now know it. In practical terms, it is prudent for physicians, patients, and payors to be wary of the findings presented in even the top journals.
One of the beauties of our scientific system is that it is wildly decentralized. Scientists (and their funders) can test any hypothesis that they find interesting, and they can use whatever methods they prefer. Likewise, journal editors can publish whatever they want. While such academic and market freedom is attractive, it results in quite a hodgepodge of science, with replication studies and publication of null results being afterthoughts. The NIH and NSF have in the past functioned to set an agenda and demand rigor, but as their funding wanes, the chaos waxes.
The problems are scientific, but any solution will be institutional (and thus legal). I have argued for a partial solution to industry bias in my short article, called “The Money Blind: How to Stop Industry Influence in Biomedical Science Without Violating the First Amendment.” Independent scientific testing could be conducted by a neutral intermediary, which would pool funds. In a similar vein, there is also a new project of the Science Exchange, called “The Reproducibility Initiative.” This program offers to be the independent scientific agency, which attempts to validate known results. But there is not yet a large-scale funding model in place. If biomedical journal editors would at least put disclosures in their structured abstracts (an intervention we have tested), over the long run that may also nudge industry to use such gold-standard independent testing, when they have something that is truly provable. And, at least in the domain of the products regulated by the FDA, the agency should consider using its current statutory authority to push companies towards independent, robust, and replicated science.
CFP: Perspectives on Abortion, Assisted Reproductive Technologies, and Judicial Review
Call for Papers: Intersections in Reproduction:
Perspectives on Abortion, Assisted Reproductive Technologies,
and Judicial Review
Abortion and reproductive technologies have historically occupied separate realms in law, policy, and academia. In spite of some obvious and natural overlap, scholarship exploring the relationship between abortion and assisted reproduction is sparse. In 2014, Judith Daar (Whittier Law School) and Kimberly Mutcherson (Rutgers Law-Camden) will co-guest edit an issue of the Journal of Law, Medicine & Ethics devoted to articles reflecting on this relationship. JLME is a peer-reviewed journal published by the American Society of Law, Medicine & Ethics.
The guest editors are open to a wide range of scholarship from authors steeped in various aspects of reproductive justice, reproductive rights and reproductive technologies who can explore the future of assisted reproduction and abortion as matters of scholarly concern and legal regulation, especially when viewed as part of a larger movement for reproductive rights and reproductive justice. The term reproductive technologies should be interpreted broadly in this context to go beyond IVF and include a range of techniques used in conjunction with assisted methods of conception.
Questions papers might choose to tackle include, but are in no way limited to:
Introducing Contributor Kate Greenwood
Kate Greenwood is a Research Fellow & Lecturer in Law at the Center for Health & Pharmaceutical Law & Policy at Seton Hall University School of Law. She also serves as Faculty Editor of Seton Hall Law’s Health Reform Watch blog. Kate received her law degree from Georgetown University Law Center and her undergraduate degree from Swarthmore College. After law school, she was an Equal Justice Works Fellow and Staff Attorney at the Association of the Bar of the City of New York, a law clerk to federal judges at the trial and appellate levels, and an associate at Covington & Burling in New York. Her current research interests include maternal and child health policy, prescription drug and medical device regulation, and, especially, the intersection of the two.
Some of Kate’s recent publications include:
10/22: Globalization and the Future of Health Law: Harmonization or Diversity?
Petrie-Flom Center Faculty Co-Director I. Glenn Cohen will give the introduction for this event featuring Belinda Bennett, Professor of Health and Medical Law, University of Sydney.
From its earliest stages, the themes of recognizing rights and managing risks have been constant features of health law debate. More recently, globalization has become an important theme for health law. International human rights law and global public health have, for example, both become important aspects of contemporary health law. In this context, it is no longer sufficient for health law to have a purely national focus. Analyzing these trends in the development of health law, Professor Bennett considers the future development of health law and whether the trend towards globalization will lead to greater harmonization or greater diversity.
Lunch will be provided.
11/6: Harvard Reception at PRIM&R sponsored by Petrie-Flom and the Division of Medical Ethics
Please note: Due to a change in arrangements, reception guests will NOT be required to check in at the front desk and receive a name badge. You may simply proceed directly to the event room.
You can find more information on the reception and the PRIM&R conference here.
Call for Applications: Petrie-Flom Academic Fellowship, 2014-2016
Applications for the Petrie-Flom Center 2014-2016 Academic Fellowships are due on November 18, 2013. (Please note that applications submitted before November 18 will not be reviewed early.)
PURPOSE: The Academic Fellowship is a postdoctoral program specifically designed to identify, cultivate, and promote promising scholars early in their careers. Fellows are selected from among recent graduates, young academics, and mid-career practitioners who are committed to spending two years at the Center pursuing publishable research that is likely to make a significant contribution to the field of health law policy, medical innovation policy, or bioethics. For more information about current and past fellows, please visit the Fellowship Programs section of our website.
ELIGIBILITY: By the start of the fellowship term, applicants must hold an advanced degree in a discipline that they intend to apply to issues falling under the Center’s umbrella. The Center particularly encourages applications from those who intend to pursue careers as tenure-track law professors, but will consider any applicant who demonstrates an interest and ability to produce outstanding scholarship at the intersection of law and health policy, bioethics, or biotechnology during the term of the fellowship. Applicants will be evaluated by the quality and probable significance of their research proposals, and by their record of academic and professional achievement.
For more information, see the full call for applications here or contact Administrative Director Cristine Hutchison-Jones.
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