PRIM&R 2013 Advancing Ethical Research conference report: Pluripotent Stem Cell Research: Let’s Discuss Informed Consent Lunch

By Melissa LopesFellow, Division of Medical Ethics, Harvard Medical School and Director of Research Policy and Compliance, Office of the Vice Provost for Research, Harvard University

The DISCUSS project is designed to develop consensus recommendations for the use of stored biospecimens (originally consented for research) to:

  • derive iPSC lines and
  • deposit the derived lines in a cell bank or repository for widespread distribution.

The project represents a formal collaboration of NIH, CIRM and the International Stem Cell Forum. The broadly stated aim of this collaboration is to evaluate consent protocols and ethical requirements in support of ongoing collaborations and the exchange of research materials.

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FDA Food Safety Modernization Act Might Raise Trade Concerns?

By Ching-Fu Lin

At the World Trade Organization (WTO) committee dealing with food safety and other issues under the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) held approximately three weeks ago, China raised several trade concerns about the Food Safety Modernization Act (FSMA).  Other WTO members, such as Brazil, Belize, and Korea, supported China’s concerns.  One of the major points of contention was the FSMA’s import certification requirements and whether its outsourced third-party auditors will conduct food safety inspections in a manner consistent with the SPS Agreement.

Before we dig into the trade implications of the FSMA, two important questions must first be answered.  What are the FSMA import food safety requirements?  And what is the underlying rationale for such requirements?

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MISTAKE ≠ MALPRACTICE

By Alex Stein

Every lawyer with some experience in medical malpractice knows that a doctor’s mistake in diagnosing or treating a patient does not necessarily amount to negligence. Doctors sometimes make mistakes that are unavoidable or just reasonable, given the constraints under which they treat patients. For that reason, a patient would be ill-advised to sue her doctor on the mistake theory. Doing so could be a very serious mistake.

Valence v. Jefferson Parish Hosp. Dist. — So.3d —-, 2013 WL 5849724 (La. App. 5 Cir. 2013), provides a textbook illustration of that point. Read More

Twitter Round-Up 11/5

The Affordable Care Act continues to be a popular topic of discussion amongst Bill of Health contributors, who also recently touched on issues of drug approval, vaccine improvements, and provider decision making.

Frank Pasquale tweeted an article about the extremely low-cost health insurance policies that will be available to some people under the Affordable Care Act. Millions of people will be eligible for free-premium plans, but an associated risk is that people will opt for these at the expense of plans that cover necessary care. (11/4)

Art Caplan tweeted his agreement with Robert Kuttner’s blog post about the Affordable Care Act. Building on private insurance was a mistake, according to Kuttner, whereas simply extending Medicare would have been a more favorable approach. (11/4)

Art Caplan also tweeted the results of a new study from Costa Rica suggesting that just one dose of the HPV vaccine might be enough to protect women from the virus. In his tweet, Caplan suggests that such a change might make the vaccine, which is currently taken in three doses, more widely accessible around the world. (11/4)

Michelle Meyer posted an article about the difficult balance between the FDA approval process and patient needs. The author describes his experience as part of a promising trial for a treatment for polycystic kidney disease, only to be let down by the Administration’s decision not to approve the drug. (11/2)

Frank Pasquale tweeted the results of a study revealing that half of clinical decision support (CDS) alerts are inappropriately overridden by providers. CDS alerts highlight things like patient allergies, drug interactions, etc., and can be potentially dangerous when erroneously ignored. (11/3)

Amitabh Chandra posted an article comparing the rollout of the Affordable Care Act to that of Massachusetts’s healthcare program in 2006. The author highlights, among other things, differences in the laws themselves, the websites designed to implement them, and the political context of the time. (10/30)

11/7: PRIM&R Session, “Bioethics Funding at the National Institutes of Health”

Looking for a great, informative session about bioethics grants?

Bioethics Funding at the National Institutes of Health

PRIM&R 2013 Session A26

Thursday Nov. 710:30 – 11:45 a.m.

Room 305

  • Learn about NIH funding opportunities for bioethics research and scholarship
  • Receive helpful tips and tools for the grant application process
  • Provide input to NIH staff about bioethics priorities you would like to see funded
  • Meet other colleagues interested in bioethics grants
Session panelists
Liza Dawson, PhD

NIH/NIAID Division of AIDS

Joe Millum, PhD

NIH/CC-FIC

Ann Hardy, DrPH

NIH/OER

Sam Garner, MBE

HJF/DAIDS NIH/NIAID

Holly Taylor, PhD, MPH

JHU Berman Bioethics Institute

 

Please contact Liza Dawson, dawsonl@niaid.nih.gov, with questions.

Big relief for Big Pharma: Indian Patent Office rejects application for compulsory license

Aditya Gupta

By a detailed order passed last week, the Indian Patent Office rejected an application for compulsory license filed by a generic drug manufacturer BDR Pharmaceuticals International Pvt. Ltd. (“BDR”) seeking a license of Bristol Myers Squibb’s (“BMS”) Indian patent for an anti-cancer drug. The Indian Patent Office found that BDR had not made out a prima facie case for grant of a compulsory license since it had not made efforts to obtain a voluntary license from BMS on reasonable terms and conditions.

Though the Indian Patent Office did not go into the merits of BDR’s application and rejected it on preliminary grounds, this victory will help restore pharmaceutical companies’ faith in the Indian patent system.

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