Bioethics News and Events

IUCB: CME: Indiana CTSI Community Health Engagement Program workshop: http://bit.ly/bAHtYb

Fri, 19 Mar 2010 06:55 GMT

IUCB: CME: Indiana CTSI Community Health Engagement Program workshop: http://bit.ly/bAHtYb

IUCB: Health reform a hot topic for bioethicists: http://bit.ly/d4lfj8

Fri, 19 Mar 2010 02:43 GMT

IUCB: Health reform a hot topic for bioethicists: http://bit.ly/d4lfj8

IUCB: OHRP Videos: 1) Biological Specimens, 2) Adverse Events: http://bit.ly/9a3Bxp

Tue, 16 Mar 2010 08:34 GMT

IUCB: OHRP Videos: 1) Biological Specimens, 2) Adverse Events: http://bit.ly/9a3Bxp

IUCB: Comparative Effectiveness: Research Ethics in the News: A recent article in JAMA shows a lack of current comparati... http://bit.ly/aXOrzO

Mon, 15 Mar 2010 08:19 GMT

IUCB: Comparative Effectiveness: Research Ethics in the News: A recent article in JAMA shows a lack of current comparati... http://bit.ly/aXOrzO

Comparative Effectiveness: Research Ethics in the News

Mon, 15 Mar 2010 07:26 GMT

A recent article in JAMA shows a lack of current comparative effectiveness (CE) research: Michael Hochman; Danny McCormick. Hochman M, McCormick D. Characteristics of published comparative effectiveness studies of medications. JAMA. 2010 Mar 10;303(10):951-8. PubMed PMID: 20215609. In six, leading medical journals, Hochman and McCormick indentified 104 studies (32% of research articles published over 16 months) that compared the effectiveness of two or more clinical interventions. With the recent public interest in encouraging CE research and CE data-driven policy, the authors believe 32% is inadequate. They write:

The fact that only 32% of the studies in these journals evaluating medications met our criteria for CE research supports previous concerns that only limited clinical research is currently devoted to helping physicians use existing therapies more effectively.

Hoping for an increase in CE research, the authors conclude that increased public funding and new regulatory action will be needed to overcome barriers to future comparative studies:

[O]ur findings suggest government and noncommercial support should be increased for studies involving nonpharmacologic therapies, for studies comparing different therapeutic strategies, and for studies focusing on the comparative safety and cost of different therapies. In addition, our findings highlight the need for regulatory agencies like the FDA to require active-comparator trials for medication approval whenever feasible.

In an accompanying editorial, Conway and Clancy, indentify a number of next steps, including:

- a vetted inventory of CE research “so clinicians and patients can locate summaries of evidence and studies of interest;”
- attention to the best methods and appropriate resources for disseminating CE research information
- longitudinal assessments of CE research driven medicine in patient-centered care.

[Conway PH, Clancy C. Charting a path from comparative effectiveness funding to improved patient-centered health care. JAMA. 2010 Mar 10;303(10):985-6. PubMed PMID: 20215615.]

Readers looking for a quick overview of CE research and its implications in for the future of health policy and medical care can find a brief, new assessment from The Urban Institute. Elizabeth Docteur and Robert A. Berenson recently wrote: How Will Comparative Effectiveness Research Affect the Quality of Health Care? [PDF - 337 KB] The report provides a brief overview of the history of CE, describes the current debate and calls for:

- continued attention to the barriers, fears and concerns to CE research
- a plan for the dissemination of CE research that will “ensure practical implementation of findings”
- the complete integration of CE and evidence-based medicine in health care financing and delivery.

For a nuts-and-bolts account of the challenging task of translating CE research into better medical practice, see February's “A Simple Health-Care Fix Fizzles Out” by Keith J. Winstein, in The Wall Street Journal (WSJ, Feb 11, 2010). Winstein uses the “Courage” trial as a case study; see: Boden WE, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. PubMed PMID: 17387127. This study found that a common procedure, implanting stents in clogged arteries, “yields no additional benefit when used with a cocktail of generic drugs.” Following the publication of the study, the use of stent implants declined by 13% in the U.S., but only briefly. Stent use in cardiology is now back to “peak levels.” William Boden, an author of the Courage trial, explains: “Most [cardiologists] haven't voluntarily incorporated the Courage criteria into their practice …. What's going to continue to drive practice is reimbursement.”

Other Research Ethics News

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry Non-Inferiority Clinical Trials. March 2010. [PDF – 975 KB]

Kevin Naughton. Researchers' organ failure. The Independent Weekly [AU]. February 27, 2010.

Trine Tsouderos. Exploring links between genes, violence, environment. Chicago Tribune. February 25, 2010.

Andrew Zajac. FDA creates partnership to boost regulatory science. Los Angeles Times. February 25, 2010.

ICMR to set up apex committee to regulate stem cell research. DNA India. February 21, 2010.

Yaadika N Chama. Zambia bans all microbicide clinical trials. The Zambian Chronicle. February 19, 2010.

Daniel Peake. Scandalous science: scientists cheating on data. Medill Reports (Northwestern University). February 17, 2010.

Marc Gerstein. Blood Simple: Columbia University's Ten-Year Cover-Up of Patient Harm, Conflicts of Interest and Administrative Misconduct. truthout. February 16, 2010. [See, related: OHRP, Columbia and Hetastarch: Research Ethics in the News. Indiana Bioethics, October 13, 2009.]

Jonathan E. Rackoff. Whistle-Blower Protection a Must. Genetic Engineering & Biotechnology News. February 15, 2010.

Shishir Prasad. Full Stem Ahead. Forbes India. February 12, 2010.

- J.O.

IUCB: Leadership Forum Reminds Leaders of the Power of Diversity: http://bit.ly/9bROZo

Fri, 12 Mar 2010 06:32 GMT

IUCB: Leadership Forum Reminds Leaders of the Power of Diversity: http://bit.ly/9bROZo

IUCB: Transparency of Texas' NBS Transfer and Reassessing Evasive Statutory Interpretation: A recent investigative repor... http://bit.ly/aOCc8I

Tue, 09 Mar 2010 06:21 GMT

IUCB: Transparency of Texas' NBS Transfer and Reassessing Evasive Statutory Interpretation: A recent investigative repor... http://bit.ly/aOCc8I

Transparency of Texas’ NBS Transfer and Reassessing Evasive Statutory Interpretation

Tue, 09 Mar 2010 04:29 GMT

A recent investigative report from the Texas Tribune revealed new information relating to the sharing of newborn blood spots (NBS) in Texas.

In November 2009, Texas Tribune reporters contacted the Texas Department of State Health Services (TDSHS) with a record request to review agency information and activities related to the NBS as permitted under the state’s Sunshine laws. TDSHS refused, maintaining that the NBS records were confidential. After parties filed the settlement with the court, Texas Tribune inquired again to obtain the records and found that TDSHS transferred hundreds of de-identified NBS to the Armed Forces Institute of Pathology to build a mitochondrial DNA (mtDNA) registry.

The Armed Forces Institute of Pathology designed the mtDNA registry as a forensics tool to identify missing persons, solve old crimes, and eventually, share the samples internationally for law enforcement and anti-terrorism efforts. Throughout the plaintiffs’ allegations and questions, TDSHS asserted it was storing and using the NBS for medical research, never mentioning any forensic use even through plaintiffs’ attorney James Harrington specifically inquired how TDSHS used the samples. TDSHS’ provision of information relating to the mtDNA registry would have been both directly pertinent and material to answering plaintiffs’ questions about the NBS disposition and how plaintiffs chose to proceed with the lawsuit.

In addition to the information on the mtDNA registry, the records request also uncovered email communications from the time when TDSHS began storing NBS at Texas A & M University. When the storage began, Texas A & M asked to issue a press release, but a TDSHS official stated that releasing this information made him “nervous” and would “only generate negative publicity.”

Although the decision revealed in the emails prevented public knowledge of storage for research use, it demonstrates a problematic mentality that transparency poses an unnecessary burden. Remaining in the dark about research using NBS is one issue, but failing to disclose (even when asked on several occasions) that the NBS are included in a registry for forensic and future law enforcement purposes creates a multitude of distinct issues. Both explicit knowledge and consent should be required to include one’s DNA in such a database.

Following terms of the settlement agreement, TDSHS’s website lists projects for which TDSHS uses the NBS. The mtDNA registry is now included on this list of projects, and TDSHS spokesperson Carrie Williams maintains that it falls within the category of “public health research.”

Sweeping forensic and law enforcement uses into the definition of public health research warrants close analysis. First, a plain reading of each definition would clearly show that the purpose of research into the causes of autism is not remotely connected to using DNA to identity a suspected criminal. Applying such a definition extends the limits of creative statutory interpretation too far. Second, states’ legislatures have attempted to impose limits on the use of NBS and other biological samples by creating exemptions or abbreviated pathways when the samples are used for public health research. Including forensic and law enforcement purposes ignores this precision and opens the possibility that samples would be shared for even more uses that would not disclosed to the public because the state health department could use this precedent to assume this use also would constitute “public health research.”

The potential for negative publicity alone should not serve as a barrier to transparency, but rather encourage public education for why TDSHS thought giving NBS to the mtDNA registry (with proper consent) would be beneficial. Dodging specific inquiries related to the uses of NBS, failing to disclose that they were given to this registry, and subsequently classifying the registry as a public health project have created even more of a publicity nightmare than TDSHS could have imagined. Other state health departments may be wise to assess whether their own policies encourage transparency, public engagement, and a sincere interpretation of what projects constitute public health research.

--Katherine Drabiak-Syed

IUCB: Darwin Day Science Conference 2010: http://bit.ly/bRWOeU

Mon, 08 Mar 2010 03:20 GMT

IUCB: Darwin Day Science Conference 2010: http://bit.ly/bRWOeU

IUCB: Fairbanks Ethics Lecture - Privacy: An Evolving Legal Concept. March 3, 2010.: http://bit.ly/cuf6Ac

Fri, 26 Feb 2010 05:49 GMT

IUCB: Fairbanks Ethics Lecture - Privacy: An Evolving Legal Concept. March 3, 2010.: http://bit.ly/cuf6Ac

Bioethics News and Events

IUCB: CME: Indiana CTSI Community Health Engagement Program workshop: http://bit.ly/bAHtYb

IUCB: Health reform a hot topic for bioethicists: http://bit.ly/d4lfj8

IUCB: OHRP Videos: 1) Biological Specimens, 2) Adverse Events: http://bit.ly/9a3Bxp

IUCB: Comparative Effectiveness: Research Ethics in the News: A recent article in JAMA shows a lack of current comparati... http://bit.ly/aXOrzO

Comparative Effectiveness: Research Ethics in the News

Related Links and Publications

Other Research Ethics News

IUCB: Leadership Forum Reminds Leaders of the Power of Diversity: http://bit.ly/9bROZo

IUCB: Transparency of Texas' NBS Transfer and Reassessing Evasive Statutory Interpretation: A recent investigative repor... http://bit.ly/aOCc8I

Transparency of Texas’ NBS Transfer and Reassessing Evasive Statutory Interpretation

IUCB: Darwin Day Science Conference 2010: http://bit.ly/bRWOeU

IUCB: Fairbanks Ethics Lecture - Privacy: An Evolving Legal Concept. March 3, 2010.: http://bit.ly/cuf6Ac