Frakes on The Impact of Medical Liability Standards on Physician Behavior

Michael Frakes, former Petrie-Flom Center Academic Fellow and current Assistant Professor at Cornell Law School, has an interesting new article out in the American Economic Review:

The Impact of Medical Liability Standards on Regional Variations in Physician Behavior: Evidence from the Adoption of National-Standard Rules

Abstract: I explore the association between regional variations in physician behavior and the geographical scope of malpractice standards of care. I estimate a 30-50 percent reduction in the gap between state and national utilization rates of various treatments and diagnostic procedures following the adoption of a rule requiring physicians to follow national, as opposed to local, standards. These findings suggest that standardization in malpractice law may lead to greater standardization in practices and, more generally, that physicians may indeed adhere to specific liability standards. In connection with the estimated convergence in practices, I observe no associated changes in patient health.

Goldacre on Pharma Research Credibility

By Frank Pasquale

Ben Goldacre is once again arguing that pharmaceutical “industry-funded trials are too common, can’t be trusted — and bring pills to market that likely don’t work.” The NY Times features his argument today. He has exhaustively compiled problematic practices that add up to a shocking claim: “the entire evidence base for medicine has been undermined by a casual lack of transparency.” For example, here’s one vignette from his most recent book:

In October 2010, a group of researchers were finally able to bring together all the trials that had ever been conducted on reboxetine. Through a long process of investigation — searching in academic journals but also arduously requesting data from the manufacturers and gathering documents from regulators — they were able to assemble all the data, both from trials that were published and from those that had never appeared in academic papers.

When all this trial data was put together it produced a shocking picture. Seven trials had been conducted comparing reboxetine against placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal for doctors and researchers to read. But six more trials were conducted in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials were published. I had no idea they existed.

I have not come across a convincing industry or FDA response to Goldacre’s work. (I don’t find this brief letter particularly compelling.). He offers several case studies like the reboxetine one. Isn’t it time to fund systematic reviews of the evidence of effectiveness on all drugs?

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Humane Transport of Research Animals

by Suzanne M. Rivera, Ph.D.

For some time, animal rights activists in the US and abroad have been trying to pressure commercial airlines out of their long-standing practice of transporting research animals.  Last week, a coalition of more than 150 leading research organizations and institutions sent a letter to the CEOs of the targeted airlines, urging them to continue transporting animals needed for research purposes.  A copy of the coalition joint letter is available here.

The letter initiative was organized by the National Association for Biomedical Research (NABR), and had the strong support of the Association of American Medical Colleges (AAMC), the Council on Governmental Relations (COGR), the American Association for Laboratory Animal Science (AAALAS), and Research!America, to name a few.

The basic thrust of the letter can be summarized by this passage: “Your company’s commitment to transporting laboratory animals is crucial to finding treatments and cures for diseases afflicting millions of people worldwide. We ask that you continue transporting research animals, allowing lifesaving research around the world to progress.” Continue reading

Dave Purchase and Naloxone, Life Savers

By Scott Burris

Start with the sad news of the week. Dave Purchase died, aged 73. Dave was the father of needle exchange in the US, which as far as anyone can say started with Dave and a TV tray in disregard of Oregon’s drug paraphernalia law. Dave was a father figure to a whole generation (or two) of harm reduction advocates and providers. The Times obituary hits the key points in his life story, but not the calm moral force he brought to the movement. He was a man who did the right thing, modestly and steadily, and inspired others to do the same. He saved more lives than most people ever will, and had more friends. We’ll miss him.

On the good news front, Dave would have been happy to spread the word about the latest study on overdose programs using naloxone. Alex Walley and colleagues from Massachusetts reported this week in the British Medical Journal on the effects of the Massachusetts program. Between 2006 and 2009, six community overdose programs were launched to teach potential bystanders about how to recognize and respond to overdose, including with the use of nasal naloxone. Walley’s study reports that the deaths went down in places with the programs compared to places without, and that the reduction was significant in places that had a high level of implementation.

Meanwhile, the removal of legal and financing barriers to overdose programs continues to be a fairly hot item on state legislative agendas. How about every state getting on board? This would be a fine week for a series of “Dave Purchase Life Saver Acts.”

Commission Seeks Interns for Summer 2013

The Presidential Commission for the Study of Bioethical Issues advises the President on bioethical issues that emerge from advances in biomedicine and related areas of science and technology. The Commission works 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 Commission staff performs original, archival and literature-based research, as well as policy analysis to inform the deliberations of the Commission. In order to fulfill our mission, we are seeking unpaid Summer 2013 interns. Candidates must be college graduates and have a demonstrated interest in bioethics, health, ethics, or public policy issues. Anticipated work will include research, writing, meeting preparation, and other projects as needed. Applications will be accepted through close of business February 28 and applicants will be notified at the end March.  Summer interns must commit to at least 10 weeks.

Please send cover letter, resume, writing sample(s), and references with contact information to:

Esther Yoo
Committee and Staff Affairs
Presidential Commission for the Study of Bioethical Issues
1425 New York Avenue, NW C-100
Washington, DC 20005
Esther.Yoo@Bioethics.gov

Applications by email are preferred.