IUCB News and Events

Lawsuit Challenging Myriad’s BRCA1 and BRCA2 Patents Will Go Forward: Judge Rejects Defendants’ Attempts to Preclude Plaintiffs’ Day in Court

noreply@blogger.com (Katherine Drabiak-Syed) — Wed, 25 Nov 2009 08:29:00 -0800

Association for Molecular Pathology et al. v. United States Patent and Trademark Office, et al. (S.D.N.Y. 2009) (Civil Action No. 09-4515 RWS), known as the lawsuit against Myriad Genetics challenging its gene patents related to BRCA1 and BRCA2 will go forward.

On November 1, 2009 Judge Robert Sweet handed down an order denying the defendants’ motion to dismiss. In the 85 page order, Judge Sweet accepted many of plaintiffs’ arguments set forth in the complaint and accompanying affidavits, finding that the court may properly hear the case and plaintiffs may properly sue each defendant.

The court flatly rejected defendants’ assertion that plaintiffs could not use the court as an arena to challenge questions of patentability.

Judge Sweet declined to adopt defendants’ arguments that the existence of the Patent Act as a comprehensive statutory scheme demonstrates Congressional intent to provide an internal remedy and preclude judicial challenges of the nature in this suit. The court noted that despite the USPTO’s statutory scheme to address patent questions, it does not provide a comparable statutory framework to raise Constitutional concerns and provide remedy accordingly; thus, plaintiffs may still bring an action to enforce the asserted Constitutional rights.

The court’s arrival at this reasoning is closely connected to Judge Sweet’s lengthy description of why the plaintiffs’ allegations of Constitutional violations are adequate and why the Court will not grant defendants’ motions to dismiss. The order described plaintiffs’ assertions that Myriad’s patents in question grant Myriad ownership rights over products of nature, laws of nature, natural phenomena, abstract ideas, basic human knowledge, and thought, which would violate the First Amendment. Additionally, plaintiffs pled that Myriad’s ownership of the patents in question inhibited further research, which would violate of Article I, section 8, clause 8 of the Constitution that directs Congress (and by delegation, the USPTO) to promote the progress of science.

The court also rejected Myriad’s arguments that plaintiffs could not show Myriad acted affirmatively to enforce the patents or that plaintiffs undertook meaningful preparation to potentially infringe the patents.

Judge Sweet adopted facts set forth in plaintiffs’ complaint and affidavits describing how Myriad sent out cease and desist letters to researcher plaintiffs and initiated two actions against infringers, demonstrating Myriad’s affirmative actions and willingness to enforce the patents. Importantly, the court further noted that given the widespread knowledge of the breadth of Myriad’s claims and its willingness to enforce its patents, a court would likely find that infringement of the patents would be considered willful and result in treble damages- meaning a scientist attempting BRCA research could be subject to extraordinary damages above merely compensating Myriad for any monetary losses.

Additionally, Judge Sweet accepted the researcher plaintiffs’ assertions that they are ready, willing, and able to infringe the patent because they are prepared to advance BRCA research, and or offer testing, and could do so within a matter of weeks. The court also noted that the plaintiff women affected by breast or ovarian cancer could take advantage of testing alternatives to find another test covered by their insurance or obtain a second opinion (options currently denied to them because of Myriad’s patents) that would potentially classify them as contributory infringers, meaning they could also properly sue the defendants.

The case moves forward and the court will hear parties’ oral arguments on motions for summary judgment on January 21, 2010. At this hearing, the court will decide whether there are genuine issues of material fact in dispute that would preclude the court from ruling as a matter of law for one party. If Judge Sweet’s order is any indication, a multitude of problems exist that are ripe for a hearing, and in the near future this court could squarely address these contentious issues arising from gene sequence patents. Perhaps finally the judicial system could address both the USPTO's and Congress' failure to re-examine patentability standards for gene sequences and decide whether issuing gene patents run contrary to Constitutional and statutory requirements.

-Katherine Drabiak-Syed

Newborn Blood Spot Litigation Continues in Minnesota and Texas

noreply@blogger.com (Katherine Drabiak-Syed) — Fri, 20 Nov 2009 07:09:00 -0800

The litigation occurring in Minnesota and Texas regarding the unauthorized retention and research use of newborn blood spots (NBS) continues, and has developed into respective battles seeking judicial recognition for a property and privacy interest in one’s genetic material from which governmental entities such as state health departments are not exempt.

In September 2009, the Minnesota district court heard the defendants’ motion to dismiss and motion for summary judgment in Bearder et al. v. Minnesota et al. (MDPH). MDPH argued that there are no genuine issues of material fact so the court could simply rule as a matter of law in its favor to exempt the application of the Minnesota Genetic Privacy statute to the state health department's activities as well as preclude any of the plaintiffs’ privacy claims. Following this interpretation, two active bills in the Minnesota House (HF 1341) and Senate (SF 1478) seek to alter Minnesota state law by creating a compliance exemption for the state health department.

According to Bearder et al.'s attorney Randall Knutson, the parties are waiting for the court’s ruling, which is scheduled for return before December 18, 2009. Plaintiffs contend that NBS are genetic information, individuals have a property and privacy interest in their DNA, both tort and Constitutional law protect these interests, and they seek to compel MDPH’s compliance with the Minnesota Genetic Privacy Act.

Bearder et al.’s memorandum of law submitted to the court prior to the hearing developed concerns related to MDPH’s continued noncompliance with the Minnesota Genetic Privacy Act. Mark McCann, Manager of Public Health Laboratory in the Newborn Screening Program testified before the Minnesota Senate that “the number of parents who have given consent to store…the residual dried blood spots with the Minnesota Department of Health is zero” and despite the Minnesota Genetic Privacy Law requiring that the MDPH obtain parental consent for retention and research use, according to McCann, actually obtaining consent is not a current practice.

The memorandum also describes the intersection of problematic shortcomings related to parental requests for destruction, “de-identification,” and research sharing with outside entities such as MDPH’s $6 million contract with the Mayo Clinic. According to plaintiffs’ affidavits, some parents were not even told that the specimens would be retained and used for genetic research purposes (undermining the ability to request their destruction) or their requests for destruction were not honored. MDPH refers to its system of storing and sharing the NBS as “de-identified” but it provides linked and coded NBS to the Mayo Clinic, retains the key to re-link the specimens (meaning they are not in fact “de-identified,”) and admits there is no standardized procedure for this process.

In Texas, the companion case Beleno et al. v. Texas Department of State Health Services et al. (TDSHS) asserts that individuals have a fundamental privacy interest in their DNA, which exists even absent any statutory provision specifically recognizing genetic privacy. On September 22, 2009, the Texas district court judge denied TDSHS’s motion to dismiss, meaning the court would schedule a hearing for the merits of the case unless the parties arrived at an alternate settlement. The Texas Civil Rights Project which represents plaintiffs indicated that the parties are in settlement negotiations, but as of November 20, 2009, parties have yet to sign an agreement.

Even if parties reach a settlement, Beleno et al.’s arguments used in this case merit pause and further examination. In plaintiffs’ response to defendants’ motion to dismiss, Beleno et al. argue that the defendants committed unlawful and unreasonable seizure, because although parents may have consented to providing the NBS for screening tests, they did not consent to the retention and research use of NBS. Even if the NBS were de-identified, plaintiffs argue that TDSHS unlawfully seized the specimens if they did not obtain actual parental consent, highlighting that issues of consent and privacy are both distinct yet inextricably linked both in practice and legal analysis. Importantly, Beleno et al. also argue that passive storage even absent any additional research or sharing of NBS constitutes a per se violation of Constitutional and tort privacy principles given the fact that they contain deeply private medical and genetic information.

Independent of how these courts proceed, these two cases continue to ask:

Do, or should, we have a property or privacy interest arising from tort or Constitutional principles in our genetic material (here, in the form of NBS) that requires consent to transfer this interest?
Can we minimize the potential for future litigation simply by obtaining parental consent for retention and research use?
Would creating codified exemptions for state health departments deter or encourage privacy advocates from litigation?

-Katherine Drabiak-Syed

Bioethics Journal Club: Religious Belief and Surrogate Decision Making

Mon, 09 Nov 2009 07:06:10 -0800

Please join us for the next meeting of the Bioethics Journal Club on Thursday, November 12th from 4:00-4:45pm at the IU Center for Bioethics, 410 W 10th Street, Suite 3100, Indianapolis, IN.

The Bioethics Journal Club meeting will be an informal discussion led by Meg Gaffney, MD. Dr. Gaffney is a Faculty Investigator at the Indiana University Center for Bioethics and Clinical Associate Professor in the Department of Medicine. In addition, she is the director of the Introduction to Clinical Medicine Course and of the Moral Reasoning and Ethical Judgment competency in the revised curriculum of the Indiana University School of Medicine. Dr. Gaffney also chairs the Wishard Ethics Committee, serves on the Clarian and Riley Hospital ethics committees, and collaborates on the Indiana University Conscience Project. She will facilitate a discussion on an article entitled “Religious Belief and Surrogate Medical Decision Making.”

Light refreshments will also be provided. Contact Maureen Craney at mocraney@iupui.edu for more information.

Center News, October 2009 « Indiana Bioethics

Wed, 04 Nov 2009 08:33:41 -0800

Research Ethics News Digest - October 2009

Wed, 04 Nov 2009 08:32:13 -0800

Sound Ethics - Taming The Beloved Beast: How Medical Technology Costs Are Destroying our Health Care System

Wed, 04 Nov 2009 08:31:59 -0800

Progress in Bioethics - The MIT Press

Wed, 04 Nov 2009 08:31:25 -0800

Center News, October 2009

Thu, 29 Oct 2009 12:21:37 -0700

Activities

The Center’s Dr. Meg Gaffney and her husband and teaching partner, Dr. Matthew Galvin, recently began a 6 week seminar series on Understanding Conscience in Ethics and Faith Experience at Trinity Episcopal Church in Indianapolis. The short course is offered for all persons at Trinity Church who are interested in conscience development and functioning, and especially those who have the opportunity to shape the development of conscience in young people. During the course participants will engage in conscience sensitive tasks, explore the essential domains of conscience, learn about connections between psychology and values, appreciate change and diversity in the contours of conscience across a lifespan, recognize moral dilemmas and identify strategies for resolving them, and, with the help of clergy, discuss conscience in the context of faith.

Faculty Investigator, Dr. Peter Schwartz will contribute to a panel discussion entitled “The Policy Path for Comparative Effectiveness” at the Indiana Life Sciences Collaboration Conferences Series, Comparative Effectiveness: The Dollars and Sense (November 13, 2009).

Sound Ethics

Eric M. Meslin, Ph.D., director of the IU Center for Bioethics and Daniel Callahan, Ph.D., senior research scholar and President Emeritus of the Hastings Center, will discuss Callahan’s new book, Taming the Beloved Beast: Why Medical Technology Costs are Destroying Our Health Care System. Visit Sound Medicine for more information.

Publication

The MIT Press has published a new book in its Basic Bioethics series which includes a chapter by Eric M. Meslin, “Can national bioethics commissions be progressive? should they?”. See: Moreno JD, Berger S. Progress in bioethics: science, policy, and politics. Cambridge, MA, MIT Press, 2010.

New Items in the Bioethics Digital Library

Survey Research Center at IUPUI. Public attitudes regarding genetic research: survey methods and findings. Indianapolis: Indiana University-Purdue University, Indianapolis. April 2009. http://hdl.handle.net/1805/1959

Schwartz PH. The value of information and the ethics of personal-genomic screening. Am J Bioeth. 2009 Apr;9(4):26-7. http://hdl.handle.net/1805/1962

Gaffney MH. Strange bedfellows: torture and medical professionals. [Presentation]. May 28, 2008. http://hdl.handle.net/1805/1960

Upcoming Events

Melissa Cavaghan, MD; Alexia M. Torke, MD, MS,; Lucia D. Wocial, RN, PhD. Clinical & Ethical Aspects of Caring for Transgendered Persons. Fairbanks Ethics Lecture Series. November 4, 2009. 12:00-1:00 PM, Methodist Petticrew Auditorium.

Susan Lederer. The Politics of Pounds and Ounces: How Obesity Became a Public Health Issue. November 12, 2009, 12:00 – 1:00, Medical Science Building, Room 311 A/B.

Richard Gregory and William Schneider. “Temples of the Future: Laboratories of the 19th Century” A viewing and discussion of “Dr. Ehrlich’s Magic Bullet” (1940), Spirit & Place Festival. November 13, 2009. 7:00–9:30 p.m., Indiana Medical History Museum Amphitheater, 3045 W. Vermont Street. Registration is required at www.imhm.org.

Peter Schwartz. “Using Numbers to Change Minds: Using ‘Personalized’ Risk and Benefit Data to Influence Decision Making in Medicine”. November 16, 2009. 2:00-3:00, Indiana University Center for Bioethics.

Eleanor Kinney, “Professional Profiteering in Failed Health Care Services Markets”. November 19, 2009. Health Care Ethics Seminars, Poynter Center for the Study of Ethics and American Institutions,618 East Third Street, Bloomington IN.

Fairbanks Ethics Lecture Series 2009-2010
History of Medicine Speaker Series, 2009-2010
PredictER Meetings, Fall Schedule 2009
Poynter Center for the Study of Ethics and American Institutions, Fall 2009 Events
Purdue Bioethics Seminar Series, Schedule 2009 – 2010

- J.O.

Not Reporting Harm: CONSORT and Clinical Trials

Wed, 28 Oct 2009 14:36:00 -0700

In 2004 an extension to Consolidated Standards of Reporting Trials (CONSORT) to aid in the reporting of adverse events was published (see: Ioannidis JP. PubMed PMID: 15545678), but did it work? Are the studies published in leading medical journals doing a better job of reporting negative “side effects” in clinical trials? Not according to a new review published in the Archives of Internal Medicine.

In “Reporting of Safety Results in Published Reports of Randomized Controlled Trials,” Isabelle Pitrou and her co-authors conclude “that despite the publication of a CONSORT statement extension for harm-related data, the reporting of harm remains inadequate.” Not only did 18% of studies fail to provide numerical data about adverse events in each trial arm, but 27% did not include information about the severity of events while 47% failed to report adverse event related patient withdrawals from the trials.

In a related editorial, John P.A. Ioannidis laments the ongoing “plague” of poor reporting of adverse events in randomized trials. In addition to faulty study design and professional neglect, he also cautions against restricted reporting, intentional distortion of results (in the literature and the media), and even (in some conflicts of interest cases) the “orchestrated silencing of the evidence.”

References:

Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169(19):1756-1761. PubMed PMID: 19858432

Ioannidis JP. Adverse events in randomized trials: neglected, restricted, distorted, and silenced. Arch Intern Med. 2009;169(19):1737-1739. PubMed PMID: 19858427

Related:

The CONSORT Group – http://www.consort-statement.org/

John Gever. Spotty Reporting of Adverse Events Noted in Big-Name Journals. MedPage Today. October 26, 2009.

Karen Kaplan. What researchers don’t want you to know about their clinical trials. Los Angeles Times. October 26, 2009.

Other Research Ethics News

Ju-min Park. Disgraced cloning scientist Hwang Woo-suk guilty of embezzlement. Los Angeles Times. October 27, 2009.

Related:

Mark Henderson. Hwang Woo-suk’s cloning fraud has not set back stem cell research. Times Online. October 27, 2009.

David Cyranoski. Woo Suk Hwang convicted, but not of fraud. Nature News. October 26, 2009.

Stacy Battenberg. Group receives ethics research grant to protect human subjects. The Minnesota Daily. October 26, 2009.

Julie Steenhuysen. Risks to personalized medicine seen in U.S. reform. Reuters. October 26, 2009.

Duff Wilson. Research Uproar at a Cancer Clinic. The New York Times. October 22, 2009.

National Institutes of Health (NIH). Notice on Development of Data Sharing Policy for Sequence and Related Genomic Data. NOT-HG-10-006. October 19, 2009.

David Armstrong. New Conflict Rules at Medical Journals. The Wall Street Journal. October 14, 2009.

A Clear Line on Stem Cells. The Washington Post. October 10, 2009.

Simon Baron-Cohen. Studying autism genetics responsibly. BioNews. October 5, 2009.

- J. O.

Virtue Ethics for CBPR? Research Ethics in the Academic Literature

Tue, 20 Oct 2009 09:01:43 -0700

Community-based participatory research (CBPR), by definition, includes communities as partners in the research process. Therefore, although individual research participants (also known as “human subjects”) may be sufficiently protected, the barriers and risks of full community participation will also need to be addressed. Are the ethical principles of “autonomy,” “nonmaleficence,” “beneficence,” and “justice” enough or do we need more than the principles-based approach of the Belmont Report to resolve the ethical issues in CBPR?

In “A virtue ethics guide to best practices for community-based participatory research”, Marjorie A. Schaffer proposes the addition of a virtues approach to the ethics toolbox. A list of relevant virtues might vary depending on the context, but Schaffer chooses to focus on six: compassion, courage, honesty, humility, justice, and practical reasoning. For example, Schaffer observes: “The compassionate researcher will imagine what the research experience is like for community partners and participants.” Likewise, the author advocates for humility because it can “guide the researcher to examine the inadequacies in their own understanding of community experiences and viewpoints as well as examine both knowledge and lack of knowledge in implementing the research process.” Schaffer devotes the most attention to justice, which, among other things, “means including vulnerable and disadvantaged populations in one’s research agenda, planning research that will benefit these groups (based on their input), and using research findings to contribute to improved social conditions.”

In this paper, Schaffer provides a good overview (with plenty of references) of the value of the virtues to the practice of ethical research in the community. In addition, the table of “best practices” walks through the CBPR steps and marks the places in which the virtues can assist. It seems to me, however, that a few issues will need to be addressed before a virtue ethics approach can be widely recognized and explicitly employed in CBPR. First, how do we teach (Schaffer suggests mentoring) and systematize the virtues? Is it really possible? Second, which virtues do we chose and why? And finally, Schaffer notes that “virtue ethics supports a collaborative approach”, but it might be more accurate to say that a collaborative approach requires or even instills the virtues in its practitioners. In other words, which comes first, the ethics or the eggs?

Reference:

Schaffer MA. A virtue ethics guide to best practices for community-based participatory research. Progress in Community Health Partnerships: Research, Education, and Action. 2009 3(1), 83-90. DOI: 10.1353/cpr.0.0053

Related:

Frey WJ. Teaching virtue: pedagogical implications of moral psychology. Sci Eng Ethics. 2009 Sep 1. PMID: 19728163.

Holland S. The virtue ethics approach to bioethics. Bioethics. 2009 Aug 25. PMID: 19709078.

Shore N, Wong KA, Seifer SD, Grignon J, Gamble VN. Introduction to special issue: advancing the ethics of community-based participatory research. J Empir Res Hum Res Ethics. 2008 Jun;3(2):1-4. PMID: 19385741.

Other Recent Research Ethics Articles (October 2009)

- J.O.

OHRP, Columbia and Hetastarch: Research Ethics in the News

Tue, 13 Oct 2009 08:41:02 -0700

Jeanne Lenzer and Shannon Brownlee, in investigative coverage published by the Huffington Post, report that the Office of Human Research Protections have requested Columbia University to notify research subjects that they may “have suffered harms that were a function of the design and procedures of [a] study” conducted a decade ago. According to the Huffington Post, some of the patients in a study (“Effect of different intravenous fluids on thromboelastography during cardiac surgery”) had adverse reactions to a blood-expanding solution (a potential substitute for blood transfusion) which contained hetastarch. Some patients, in the study partially funded by Abbott Laboratories, suffered from excess bleeding during surgery and at least two patients died.

Howard Brody at Hooked: Ethics, Medicine, and Pharma observes that this case has been “tossed around since 1999″ and that it “defies a quick summation.” Lenzer and Brownlee, however, do a good job of digging up key documents and of telling a story obscured by past (and future?) lawsuits. Clearly the study was a nightmare for all involved: the PI (Elliott Bennett-Guerrero), the IRB at Columbia University College of Physicians and Surgeons, Abbott Laboratories, the surgeons, and (most importantly) the patients. One gets the impression from reading this story that no one wanted to harm patients and that, while all the parties involved were doing their jobs, they were trying to do too much–a member of the IRB lamented “[m]ost of us barely get to read the birthday cards from our kids . . .” and Bennett-Guerrero was “simultaneously running 25 clinical trials.”

According to Lenzer and Brownlee, the OHRP’s letter to Columbia (June 8, 2009) requires the institution to draft a letter explaining the study and the likelihood that patients who received hetastarch did worse than the others (including excess bleeding, decreased renal function, and an increased need for re-operation). Assuming that Columbia will comply with this request, what will these patients do now?

Other Research Ethics News

John Schmid. UW calls proposal to change patent law ‘reckless’. Milwaukee Journal Sentinel. October 9, 2009.

Meg Tirrell. Doctors Fail to Report $12 Million in Industry Fees at Meeting. Bloomberg.com. October 7, 2009.

Chris Kaposy. The H1N1 Vaccine and Pregnant Women. Bioethics Forum. October 6, 2009.

John Timmer. Anonymized genetic research data still carries privacy risks. Ars Technica. October 6, 2009.

IU Center receives NIH grant to improve privacy protection in medical research. IU News Room. October 5, 2009.

Ed Silverman. Out of sight. Portfolio.com. October 5, 2009.

Michael Rugnetta. Collins Reports to Colbert. Science Progress. October 2, 2009.

Shelley Wood. New “principles” on authorship and COI from PhRMA get mixed response. TheHeart.org. October 2, 2009.

- J.O.

Comparative Effectiveness: Humanities Initiative Grant Awarded to the Center for Bioethics

Fri, 02 Oct 2009 11:37:01 -0700

The Indiana University Center for Bioethics (IUCB) has recently been awarded a $1,300 Humanities Initiative Grant for a new Comparative Effectiveness (CE) project. The official title of the project is, “Ethical and Social issues in Comparative Effectiveness Research: How the Humanities can Contribute to the Developing National Conversation about Research Reform.” It is Co-sponsored with IU School of Liberal Arts, Department of Philosophy and the IU-School of Law Indianapolis, Hall Center for Law and Health and works closely with the School of Public and Environmental Affairs, Center for Health Policy.

Current discussion of healthcare reform emphasizes the importance of determining what drugs, treatments, and procedures work best, in order to improve healthcare and control spending. However, carrying out CE research and healthcare raises crucial ethical, legal, and social issues. Measuring “effectiveness” requires quantifying and comparing diseases, disabilities, and suffering, which raises profound moral questions about how society should make these assessments and then utilize them. The technical aspect of CE assessment can be done by mathematicians, statisticians, and economists. However, the corresponding ethical, legal, and social issues can only be addressed through conversations amongst the humanities and social sciences.

The need to conduct comparative effectiveness research and use it as a cornerstone in healthcare reform stems from recognition that healthcare in the United States excessively adopts forms of testing and treatment that are expensive and ineffective. CE can involve complex questions and tradeoffs. In many cases the most effective treatment is also the most expensive, leading to questions about when an increase in effectiveness is worth an increase in cost. For instance, an extremely expensive drug for treating cancer may cost hundreds of thousands of dollars per patient but extend life by only a few months. When insurance companies cover such treatments the costs rise and more people go without health insurance. The uninsured and under-insured then forgo treatments that are most effective and inexpensive. Instead, they end up in the emergency room much sicker than they would have been and requiring much more expensive care. As health care costs keep rising there is a need to know what we have to show for it.

The IUCB collaborative project comprises of two substantial efforts. It will host at least two public lectures by prominent humanities experts focusing on the ethical, legal, and social issues raised by comparative effectiveness research. It will also convene a year-long Comparative Effectiveness Study Group (CESG) from September 2009 – May 2010. CESG will read the most important literature on the ethical, legal, and social issues raised by CE research. The goals of both projects are to produce academic publications. Contribute to informed policy development within the state, and provide the public with additional knowledge to aid in their own deliberations on these issues. Experts from different areas of the humanities will provide leadership including: Eric Meslin PhD (Philosophy, IUCB), Peter Schwartz MD, PhD (Philosophy, IUCB), Eleanor Kinney, JD (Law School), Ralph Hall JD (Law School), Jason Eberl PhD (Philosophy), and Eric Wright PhD, (Health Policy, SPEA).

Center News, September 2009

Wed, 30 Sep 2009 10:33:27 -0700

This month Indiana University Center for Bioethics worked with its collaborators to launch two new initiatives: an International Research Ethics concentration (a new track in the Masters degree offered by the Department of Philosophy) and the Comparative Effectiveness Study Group. The International Research Ethics (IRE) concentration offers students and professionals the opportunity to study the ethical and policy issues of research involving multinational populations and partners. Read the press release or learn more about this new educational opportunity on our website at bioethics.iu.edu/irema.

The Comparative Effectiveness Study Group (CESG) was recently funded by the Indiana Humanities Council to provide two public lectures. The CESG is comprised of experts from The Center for Health Policy, The Hall Center for Law and Health, the Center for Bioethics, and other friends of the Consortium for Health Policy, Law and Bioethics. The Group will examine the ethical, legal and policy issues of comparative effectiveness research.

Events

Be sure to attend ethics events hosted by our friends and partners.

Lucia D. Wocial, RN, PhD. Checking the Vital Signs of Clarian Nurses: Where are we with Moral Distress? Fairbanks Ethics Lecture Series. October 7, 2009. 12:00-1:00 PM. Riley Out-Patient Center Auditorium. [View the entire 2009-2010 Schedule.]

Jason Eberl, PhD. Discussing: Buchanan A. Human nature and enhancement. Bioethics. 2009 Mar;23(3):141-50. Bioethics Journal Club. October 8, 2009. 4:00-4:45 PM. IUCB, HITS 3139.

Rob Kunzman. Write These Laws On Your Children. Poynter Center Roundtable. October 8, 2009. 4:00-5:30 PM. Poynter Center for the Study of Ethics and American Institutions, 618 East Third Street, Bloomington IN 47405-3862. [Poynter Center Roundtables, Fall 2009]

Guo Liping, Associate Director, Medical Humanities Institute, Peking University Health Science Center . Medical Humanities in China. October 19, 2009, 12:00 – 1:00 PM. CA Room 438. [View the entire 2009-2010 schedule – PDF 38 KB.]

Robert Crouch. Medical Interventions on Children for Nonmedical Reasons: How Far May Parents Go? Health Care Ethics Seminars. October 22, 2009. 4:00-5:15 PM. Poynter Center for the Study of Ethics and American Institutions, 618 East Third Street, Bloomington IN 47405-3862. [View the Health Care Ethics Seminars, Fall 2009 schedule.]

Robert Katz. The Tissue Transplantation Industry: A Case Study in How Market Actors Can Reduce Transaction Costs by Economizing on Moral Externalities. October 26, 2009. 3:00-4:00 PM; IUCB, HITS 3139. [View PredictER's Fall 2009 Schedule; PDF - 59 KB.]

New Items in the Bioethics Digital Library

Schwartz PH. Decision and discovery in defining ‘disease’. In: Kincaid H, McKitrick J, editors. Establishing medical reality: essays in the metaphysics and epistemology of biomedical science. Dordrecht: Springer; 2007. p. 47-63. http://hdl.handle.net/1805/1944

Schwartz PH. Defining dysfunction: natural selection, design, and drawing a line. Philosophy of Science. July 2007;74(3):364-385. http://hdl.handle.net/1805/1943

Schwartz PH, Meslin EM. The ethics of information: absolute risk reduction and patient understanding of screening. J Gen Intern Med. 2008 Jun;23(6):867-70. http://hdl.handle.net/1805/1942

Schwartz PH. Disclosure and rationality: comparative risk information and decision-making about prevention. Theor Med Bioeth. 2009;30(3):199-213. http://hdl.handle.net/1805/1935

J.O.

Peer Review: Research Ethics in the News

Thu, 24 Sep 2009 09:33:56 -0700

Earlier this month, The Sixth International Congress on Peer Review and Biomedical Publication (PRC) met in Vancouver. Sessions and posters addressed a number of research ethics issues, including: ghost writing, ethical and editorial standards, conflicts of interest, bias and “spin”, clinical trials registration, and quality reporting. Of these, the topic of ghost writing in medicine, continues to make headlines. The New York Times reports the results of a study published in JAMA (this research was also presented at PRC; see MedPage Today). The Guardian reports that a British doctor faces disciplinary action for his role in “writing”. The Chronicle of Higher Education pursues a different angle and covers the cost (to journals) of fighting industry support. The Philadelphia Inquirer covers a Paxil suit and the GlaxoSmithKline (GSK) project CASPPER–that’s “Case Study Publications for Peer Review” (the allusion to Casper the ghost is defended as a “whimsical” choice). The president of Chadds Ford, the involved writing company, also notes: “At that time, around 2000, there were no negative ethical implications associated with the term ghostwriter.” For additional reading, the topic of ghost writing was also covered in an earlier post at this blog; also see the ongoing attention to the issue by Stuart Laidlaw of the Toronto Star on his Medical Ethics blog: Ghostwriting.

Other PRC related topics were also widely reported this month, including: registering clinical trials in The New York Times, Nature News [subscription required], and Science Progress; conflicts of interest in AMNews; ScienceNews reports that reviewers do not get better with practice; and Chris Lee at Ars Technica reflects on the results of a new survey from the Publishing Research Consortium.

Other Research Ethics News

Jocelyn Kaiser. To help young scientists, NIH bends quality rules. ScienceInsider. September 22, 2009.

Nancy Walton. Moving Ethics Review Out of the institution: Are We Throwing Caution to the Wind? The Research Ethics Blog. September 22, 2009.

NIH Opens Website for Human Embryonic Stem Cell Lines for Approval and Announces Members of Working Group. NIH News. September 21, 2009.

Michael B. Blank, Patrick S. Sullivan and Paul A. Lombardo. When Less Paperwork Means No Science: The Paperwork Reduction Act and Unintended Consequences for Public Health Research. Science Progress. September 21, 2009.

New Program in International Research Ethics Commences at IUPUI. Indiana University School of Medicine. September 17, 2009.

Sean Teehan. Monkeys suffered in lab, suit says. The Boston Globe. September 17, 2009.

Bob Grant. More regulatory science: FDA chief. The Scientist. September 17, 2009.

Gardiner Harris. Where cancer progress is rare, one man says no. The New York Times. September 15, 2009.

Laura Donnelly. Human tissue can be taken for human-animal embryo experiments without consent. Telegraph.co.uk. September 12, 2009.

Kevin B. O’Reilly. Outsourcing clinical trials: Is it ethical to take drug studies abroad? AMNews. September 7, 2009.

- J.O.

Data Sharing and Privacy: In the News

noreply@blogger.com (PredictER) — Tue, 22 Sep 2009 16:50:00 -0700

Roughly one year after the NIH and The Wellcome Trust restricted access to genome-wide association studies [see: Modifications to Genome-Wide Association Studies (GWAS) Data Access (NIH, August 28, 2008 - PDF)], data sharing is back in the news. In August, researchers in Tel Aviv and Berkeley announced a new method of protecting the privacy of individuals in genetic research studies. In the press release, one of the authors, Eran Halperin, alludes to the PLoS Genetics paper that led to the NIH's data access modifications (Homer N, et al.). As Halperin sees it, the "knee-jerk response stymied potential breakthrough genetic research." Perhaps he hopes that the new privacy approach will re-open the doors of safe data sharing. Halperin's method (published in Nature Genetics) uses a likelihood ratio (LR) test to measure the risk of exposing a single individual within a data set. Ultimately, the LR test limits the number of SNPs shared and thereby decreases the chances of privacy losses. If you would like to give this method a try, the software is available online (with registration) at SECUREGENOME.

In related news, The Toronto International Data Release Workshop (Genome Canada, May 2009) recently recommended the "rapid release of prepublication data" to speed the pace of scientific discover. The recommendation was published in a special, data sharing edition of Nature. The Workshop cites the Human Genome Project as an example of how sharing data leads to public benefits: "This experience ultimately demonstrated that the broad and early availability of sequence data greatly benefited life sciences research by leading to many new insights and discoveries, including new information on 30 disease genes published prior to the draft sequence." In a note addressing the human subjects concerns, the Workshop acknowledges the privacy risks: "Data about human subjects participating in genetic and epidemiological research require particularly careful consideration owing to privacy-protection issues and the potential harms that could arise from misuse. ... [F]or clinical and genomic data that are associated with a unique, but not directly identifiable individual, access may be restricted."

Will these developments (a proposed technical solution to the privacy barrier and a reaffirmation of the social benefits of data sharing) encourage the NIH and The Wellcome Trust to reduce some of the restrictions on data sharing? (I’d say: not yet.) While the safety of data sharing may be increased with technical solutions, it seems unlikely that all privacy risks will be eliminated. After all, if I share something "private" with you (or with anyone else), it's not so "private" any more. At the same time, if data access is restricted (for example, by using smaller, "safer" data sets), the public benefit of sharing resources declines. Clearly, we are looking for a way to eat our cake and have it too; protecting the individual's privacy while sharing for common benefits. Perhaps we should ask ourselves, what are the risks that we are willing to impose on individuals for the benefit of the common good? As an individual, exactly how private is your privacy? And at what cost?

References:

Homer N, et al. Resolving individuals contributing trace amounts of DNA to highly complex mixtures using high-density SNP genotyping microarrays. PLoS Genet. 2008 Aug 29;4(8):e1000167. PMID: 18769715

Sankararaman S, Obozinski G, Jordan MI, Halperin E. Genomic privacy and limits of individual detection in a pool. Nat Genet. 2009 Sep;41(9):965-7. Epub 2009 Aug 23. PMID: 19701190.

Toronto International Data Release Workshop Authors, et al. Prepublication data sharing. Nature. 2009 Sep 10;461(7261):168-70. PMID: 19741685.

Other Predictive Health Ethics News

Nikki Tait. Pan-European biobanking moves closer. Financial Times. September 16, 2009.

Michael Rugnetta and Whitney Kramer. Paving the Way for Personalized Medicine. Science Progress. September 14, 2009.

Daniel Vorhaus and Lawrence Moore. What happens when a personal genomics company goes bankrupt? Genetic Future. September 14, 2009.

Caroline Wright. HGC public consultation on DTC genetic testing services. PHG Foundation News. September 8, 2009.

Over Ninety Per Cent Of Pathologists Find Research Rules Too Complex. Medical News Today, September 8, 2009.

Jane E. Brody. Buyer beware of home DNA tests. The New York Times. August 31, 2009.

Brad Therrell, Harry Hannon, Don Bailey, et al. Considerations and Recommendations for a National Policy Regarding the Retention and Use of Dried Blood Spot Specimens after Newborn Screening. Genetic Alliance. August 21, 2009.

Turner Ray. Lack of Physician Education, Genetic Counseling Could Ruin Value Proposition of PGx Testing, Insurer Says. Genomeweb: Pharmacogenomics Reporter. August 12, 2009.

The Genetics and Public Policy Center. Center publishes new survey of state false advertising laws. dnapolicy.org, August 11, 2009.

Related: State Laws Could Cover DTC Gene Testing. GenomeWeb Daily News, August 13, 2009.

- J.O.

Syphilis, Lead Paint and the IRB: Research Ethics in the Academic Literature

Tue, 15 Sep 2009 12:03:18 -0700

Many of the current human subject protections were formed with the disastrous consequences of the well-known Tuskegee Syphilis Study in mind. While we all hope that these rules have made the practice of human subjects research safer, they cannot prevent future disasters without the reliable performance of the individuals and organizations. The Kennedy Krieger Institute Lead-Based Paint Study (KKI), in which researchers measured the blood lead levels of children living in homes that received differing methods of lead abatement, for example, became a public scandal and legal disaster many years after Tuskegee, even though the study was reviewed by institutional review boards (IRBs). Will IRBs fail to stop similar studies in the future? What can institutions do to decrease the likelihood of seeing another Tuskegee or KKI debacle in the future?

To begin to answer these questions, Barry Bozeman, Catherine Slade and Paul Hirsch in “Understanding Bureaucracy in Health Science Ethics: Toward a Better Institutional Review Board” propose studying the organizational behavior of IRBs. The authors assert that IRBs as organizational systems are functioning well with a large number of low-risk, routine decisions, but are more likely to fail when confronting idiosyncratic and novel decisions. The authors point to the KKI case as an example and note: “There is no evidence that IRB procedures differed significantly in this case from hundreds of other instances, ones that drew less attention and escaped the wrath of the press and the public.” In other words, the day the KKI study was approved, the IRB was just doing its job, but (we know now) that clearly was not enough.

Before addressing these potential vulnerabilities in IRB decision making, the authors propose that IRBs themselves become the subject of future behavioral research studies. They propose three well-used methods: case studies, survey research, and experiments or simulations. While IRB members and the institutions they serve might resist studies of their decision making behavior, the authors remind us: “There is no reason to assume that IRB processes should prove a more intractable learning environment than, say, corporate board rooms, air control towers, space centers, or war rooms.”

Reference:

Bozeman B, Slade C, Hirsch P. Understanding bureaucracy in health science ethics: toward a better institutional review board. Am J Public Health. 2009 Sep;99(9):1549-56. PMID: 19608947

Related:

Bozeman B, Hirsch P. Science ethics as a bureaucratic problem: IRBs, rules, and failures of control. Policy Sci. 2006; 38:269–291. doi:10.1007/s11077-006-9010-y

Buchanan DR, Miller FG. Justice and fairness in the Kennedy Krieger Institute lead paint study: the ethics of public health research on less expensive, less effective interventions. Am J Public Health. 2006 May;96(5):781-7. PMID: 16571697

Candilis PJ, Lidz CW, Arnold RM. The need to understand IRB deliberations. IRB. 2006 Jan-Feb;28(1):1-5. PMID: 16680872

Other Recent Research Ethics Articles (September 2009)

– J. O.

NSF Requires Ethics Education: Research Ethics in the News

Wed, 09 Sep 2009 14:38:21 -0700

The National Science Foundation (NSF) will require all institutions applying for funding to provide ethics education for grantees. The new requirement, reported in the Federal Register [August 20, 2009 (Volume 74, Number 160), 42126-42128], will go into effect on January 4, 2010. At that time, grant proposals to NSF must describe “a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduate students, graduate students, and postdoctoral researchers participating in the proposed research project.”

Bob Grant at The Scientist acquired comments from John Galland and John Dahlberg (from the Office of Research Integrity) on the news. Galland pointed to the difference between the NSF and the NIH approach to encouraging the responsible conduct of research. Both Galland and Dahlberg see research ethics education as a wise investment, but Dahlberg cautions, “There are still going to be bad actors.”

During the public comment period the new guidelines received 188 comments, many of these included concerns about training guidance and access to online resources. In response, the NSF points to existing and recently NSF funded ethics education resources, including:

Ethics Education in Science and Engineering (EESE)

National Digital Library for Ethics in Science & Engineering

Online Ethics Center

Also see a report detailing the results of an NSF workshop on ethics education is available from the National Academy of Engineering:

National Academy of Engineering (NAE). Ethics Education and Scientific and Engineering Research: What’s Been Learned? What Should Be Done? Summary of a Workshop at the National Academies Keck Center, August 25–26, 2008. Available from: http://www.nae.edu/?ID=14646

Other Research Ethics News

Roger Collier. Prevalence of ghostwriting spurs calls for transparency. CMAJ. September 9, 2009.

Karen J. Maschke. Disputes over Research with Residual Newborn Screening Blood Specimens. Bioethics Forum. September 8, 2009.

Andrew Pollack. First Stem Cell Drug Fails 2 Late-Stage Clinical Trials. The New York Times. September 8, 2009.

Public Health Association (NZ). Maori team produce new ethical research guidelines. Scoop. September 3, 2009.

Katherine Harmon. Should Doctors Disclose Conflicts of Interest to Trial Patients? Scientific American. August 27, 2009.

- J.O.

Critiquing HHS's Summary Recommendations on Newborn Blood Spots: Opt-Out is Not Optimal

noreply@blogger.com (Katherine Drabiak-Syed) — Fri, 04 Sep 2009 07:19:00 -0700

On August 21, 2009 the Department of Health and Human Services (HHS) issued “Considerations and Recommendations for a National Policy Regarding the Retention and Use of Dried Blood Spot Specimens after Newborn Screening” relating to storage and use of newborn blood spots (NBS). The agency recommendations discussed assurances of privacy and confidentiality for storage and advised that each state should disseminate policies that promote public trust, emphasize transparency, and encourage informed public participation. It promulgated seven recommendations, including: all states should have a policy in place to address NBS retention, use, and research access; states should provide educational materials to the public and expecting mothers on use and potential future uses; and states should adopt an opt-in or opt-out model if NBS are available for any process outside the screening process or internal screening test development.

However, parental attitudes and pending litigation in this area suggests that the agency’s goals to promote public trust and encourage public participation may not be achieved with these guidelines.

Tarini, et al.’s survey in Public Health Genomics examined parental willingness to permit NBS storage and research. If permission is obtained, 76.2% of parents were very or somewhat willing to permit use of NBS for research, but if permission was not obtained, only 28.2% of parents would be very or somewhat willing to permit use of NBS for research. These results show most parents will permit retention and use as long as they are asked, reiterating the importance of respecting a person’s autonomy and dignity to permit or refuse participation.

Two pending cases in Minnesota and Texas confirm the results of Tarini et al.’s study and demonstrate that collection, retention, and research use of NBS and associated PHI even if conducted or facilitated by the state department of health is biobanking research. Accordingly, it should be governed under the Common Rule and Privacy Rule, meaning actual consent is not only optimal but perhaps required.

In June 2009, Minnesota parents (Bearder, et al.) filed a civil complaint against the state of Minnesota and the Minnesota Department of Public Health (MDPH, et al.) for failing to comply with the Minnesota Genetic Privacy Act and continuing to store and use NBS without consent. The complaint contains a litany of claims, including violation of the Minnesota Genetic Privacy Act, eight tort claims, fundamental right claims, and government taking. Plaintiffs’ claims for intrusion into seclusion, fraud and misrepresentation, and government taking summarize the essence of the alleged injury:

A person has a privacy interest in his or her own blood (acting as guardian for the newborns’ blood) and the medical information that may be obtained from it;
The MDPH intentionally omitted that the NBS was not taken solely for screening but would be retained and used, knew that parents would provide them NBS for the purpose of screening, and parents relied on these representations but would not have consented to providing MDPH the NBS had they known; and
Blood and genetic information constitute a “valuable national resource” and a represent a “gold mine” for the state and affiliated researchers that the government cannot automatically appropriate even in the name of public health research.

In a prayer for relief, plaintiffs request damages as statutorily indicated, request an injunction, and a cease and desist order against MDPH. Minnesota’s history confirms that NBS collection, retention, and research falls within its Genetic Privacy Act, meaning a separate consent is required for each activity; and importantly, that the research conducted or approved by the Minnesota Department of Health is not exempt from these requirements.

In Texas, parents (Beleno, et al.) filed a civil complaint in March 2009 against the Texas Department of State Health Services (TDSHS, et al.) claiming TDSHS has no legal authority to retain and use NBS without consent. Beleno et al. assert this practice violates the privacy principles as well as violates the prohibition against seizure. Plaintiffs request that the court order the destruction of all NBS stored without consent (around 4.2 million samples) since it began the practice in 2002 or obtain retroactive parental consent. Additionally, plaintiffs seek an order to compel TDSHS to disclose for what purposes the NBS have been used and financial transactions involving the NBS.

New legislation TX HB 1672 that implements a compromise by using an opt-out system was signed into law and will take effect September 2009. It remains to be seen whether all Texas parents will agree with this solution and how the court will address the issue of what to do with the 4.2 million NBS that were stored without consent.

If NBS constitute such a valuable resource, then it is incumbent on us to encourage transparency of state health departments’ intentions by educating parents on the importance of using NBS for research purposes, how the state plans to use them, and respect parents enough not to circumvent the law’s intent but actually obtain their consent. If not, parents could turn to the judicial system and potentially prevail, creating a costly and lengthy legal battle for the state health department as well as jeopardizing the current collection of NBS.

-Katherine Drabiak-Syed

Children, Biobanks and Consent

noreply@blogger.com (PredictER) — Tue, 18 Aug 2009 11:15:00 -0700

In a recent policy forum published in the Science, ethicists argue in favor of a policy to recontact children once they reach "the age of consent" to seek permission for continued research on their DNA samples and data. The authors would make an exception for children with samples in disease-specific biobanks. As they see it, the therapeutic benefits of participation in the disease-specific biobank outweigh the risks to subject. While the authors acknowledge the difficulty of maintaining an active biobank while tracking samples and relocating subjects for adult consent, they point to the "long-term benefits of maintaining public trust in biomedical research".

In a related news story, Mats Hansson of Uppsala University in Sweden, Karen Maschke, of the Hastings Center, Ronald Green, director of the Ethics Institute at Dartmouth College, and other ethicists comment on the Science policy forum; see: Child DNA donors should have their say.

References

Gurwitz D, Fortier I, Lunshof JE, Knoppers BM. Research ethics. Children and population biobanks. Science. 2009 Aug 14;325(5942):818-9. PMID: 19679798.

Dolgin E. Child DNA donors should have their say. Nature News. August 13, 2009. doi:10.1038/news.2009.819.

Other Predictive Health Ethics News

Ameer B, Krivoy N. Direct-to-Consumer/Patient Advertising of Genetic Testing: A Position Statement of the American College of Clinical Pharmacology. J Clin Pharmacol. 2009 Aug;49(8):886-8. PMID: 19602717.

Boddington P. The ethics and regulation of direct-to-consumer genetic testing. Genome Med. 2009 Jul 20;1(7):71. PMID: 19638186

Bowen DJ, Harris J, Jorgensen CM, Myers MF, Kuniyuki A. Socioeconomic Influences on the Effects of a Genetic Testing Direct-to-Consumer Marketing Campaign. Public Health Genomics. 2009 Jul 28. PMID: 19641293

Darnovsky M, Reynolds J. The battle to patent your genes: the meaning of the Myriad case. The American Interest [Online]. September-October, 2009.

Giordano J. Quo vadis? Philosophy, Ethics, and Humanities in Medicine - preserving the humanistic character of medicine in a biotechnological future. Philos Ethics Humanit Med. 2009 Aug 14;4(1):12. PMID: 19682382

Serrano-Delgado M, Novello-Garza BI, Valdez-Martinez E. Ethical issues relating to the banking of umbilical cord blood in Mexico. BMC Med Ethics. 2009 Aug 14;10(1):12. PMID: 19678958

Wade N. Genes tied to gap in treatment of Hepatitis C. The New York Times. August 16, 2009.

Wade N. Cost of decoding a genome is lowered. The New York Times. August 10, 2009.

Wright C. Understanding DTC gentic risk prediction services. PHG Foundation News. August 14, 2009.

Wright C. Update on genetic non-discrimination legistlation. PHG Foundation News. August 10, 2009.

- J.O.

New German Law on Genetic Testing: More Than Just a German GINA

noreply@blogger.com (PredictER) — Wed, 05 Aug 2009 09:03:00 -0700

EuroGentest has recently posted an unofficial English translation of the recently passed and soon to be enacted German legislation, the Human genetic examination act (Genetic diaganosis act - GenDG) [PDF - 162 KB]. The new law addresses genetic examinations (including consent, duty to inform, counselling, and disclosure), genetic testing and insurance contracts, workplace issues (including discrimination), and criminal penalties (prison time, in some circumstances, and fines of up to EURO 300,000).

Hat tip: CanGeneTest e-Newsletter, August 3, 2009.

- J.O.

Direct-To-Consumer Baby Gender Mentor Test in a Three Year Stalemate

noreply@blogger.com (PredictER) — Tue, 21 Jul 2009 12:15:00 -0700

In 2005, news headlines excitedly shared the latest development in direct-to-consumer testing: the Baby Gender Mentor early prenatal gender detection test. Acu-Gen Biolab, Inc., a company based in Lowell, Massachusetts, claimed that as early as five weeks, pregnant women could use a simple finger-prick test to obtain a blood sample and send it to Acu-Gen who would use “established qPCR technology analysis” to determine their baby’s sex. Originally claiming their $275 test was “infallible” and 99.9% accurate with a 200% money back guarantee, many expectant women relying on Acu-Gen’s claims eagerly purchased the test.

Months later, numerous accusations surfaced relating to the accuracy of the test, Acu-Gen’s failure to honor the warranty policy, and more disturbingly, allegations that C.N. Wang, PhD, President of Acu-Gen, advised several women that the results of their gender detection test conflicted with their ultrasound results because their baby had chromosomal abnormalities or a fetal “defect.” As a result of this alleged medical advice, many women sought further testing and procedures to determine whether their baby did indeed have a chromosomal abnormality. In addition to enduring the tremendous anxiety caused by Wang’s statements, these women underwent additional procedures such as extra ultrasounds, amniocentesis, and chromosomal testing, accumulating costly and unnecessary expenses.

Why is this seemingly dated piece of news still an issue? Because it has yet to be resolved. Although thepregnancystore.com, a prior vendor of the test no longer carries the product, The Baby Gender Mentor website still sells the potentially dangerously misleading early prenatal gender detection test.

In early 2006, New Jersey law firm Gainey & McKenna filed a class action law suit, Blumer, et. al. v. Acu-Gen Biolabs, Inc., et. al. on behalf of over 100 women who purchased the Baby Gender Mentor test, claiming among other things, that Wang and Acu-Gen’s deceptive advertising, misrepresentation of the test’s accuracy, and illusory guarantee induced them to purchase an inaccurate test and caused them corresponding harm, amounting to eight counts of legal violations.

In the complaint, Blumer et. al. requested:

(1) profit disgorgement and restitution, which would recognize Acu-Gen’s unfair business practices and require them to pay Blumer and the women back, thus honoring their money back guarantee;

(2) compensatory damages, to compensate women for any other undue expenses such as the hundreds or thousands of dollars spent on additional medical testing to clarify whether their baby suffered from a chromosomal abnormality;

(3) punitive damages, to penalize the defendant’s wrongdoing and serve as a deterrent to similar companies; and

(4) injunctive relief to prevent Acu-Gen and Wang from further marketing, selling, and profiting from the test.

Acu-Gen maintains their product works, and Wang has referred to the allegations as “totally bogus.”

Although Gainey & McKenna negotiated on behalf of Blumer and arrived at a settlement agreement with Acu-Gen and Wang, according to Barry Gainey, lead counsel for the plaintiffs, both defendants reneged on their settlement agreement. The District Court of Massachusetts denied Blumer’s motion to enforce the settlement, leaving these women and all other similarly situated individuals at square one- susceptible to cutting edge and supposedly infallible technological advancements that leave them aggrieved without effective or timely recourse.

Barry Gainey confirmed that the case is still active and plaintiffs filed a motion to amend the complaint. To clarify this timetable: over three years have passed since filing serious accusations of legal violations, yet there has still not been a hearing on the case’s merits or enforceable settlement. This progression illustrates the inefficiency of the judicial system to address gaps in federal regulation and the potentially grave impact of direct-to-consumer tests.

Like many other direct-to -consumer tests available online, gender prediction tests have been treated as outside the scope of federal regulation. Despite the FDA’s mandate to regulate medical devices used in the diagnosis of disease or other conditions (such as pregnancy), the FDA has thus far declined to regulate the “home-brew” variety to direct-to-consumer tests where a laboratory such as Acu-Gen uses its own reagents and protocols. Thus, the FDA does not regulate the clinical or analytical validity of these tests. The FTC has similarly followed suit in declining to regulate the industry, despite its authority to prohibit false or misleading advertising.

Private remedy through the judicial system is ineffective in addressing the regulatory shortcomings in direct-to-consumer tests. Over three years later, and the women wronged by the Baby Gender Mentor test have yet to receive their day in court. Meanwhile, Acu-Gen continues to market, sell, and profit from a test that at best, is of uncertain validity, and more troubling, may reflect the allegations in the Blumer complaint. How many more aggrieved individuals and how many more years must the public wait until the FDA and the FTC step in?

-Katherine Drabiak-Syed

Will Stronger Privacy Protections Result in Better Health Data? The Health Privacy Project Recommendations

noreply@blogger.com (PredictER) — Wed, 01 Jul 2009 13:28:00 -0700

The Health Privacy Project of the Center for Democracy & Technology (CDT) recently released a paper arguing for changes in how the HIPAA Privacy Rule protects "de-identified" health information. The recommendations grow from a one-day, CDT workshop held in September 2008. The Health Privacy Project makes the following eight recommendations:

1. Re-examine the Privacy Rule de-identification provisions (in particular, the safe harbor method for de-identification);
2. Strengthen accountability by requiring data use agreements;
3. Expand data anonymization options under the Privacy Rule;
4. Provide incentives to use less than fully identifiable data for certain purposes;
5. Provide support through “Centers of Excellence” in de-identification;
6. Require or encourage the use of limited access datasets and other technical solutions;
7. Require education and training of staff de-identifying data; and
8. Consider increasing public transparency regarding uses of de-identified data.

The Project argues that the HHS needs to re-examine the Privacy Rule "to ensure that the de-identification standard remains robust as re-identification becomes easier."

For readers struggling with the "Babel" of data privacy vocabulary (for example, what's the difference between "anonymous" and "anonymized"?), these recommendations may open the door to additional confusion, especially if #3 (above) means that additional categories of protected data are created. The Privacy Rule currently offers two categories data which are exempt from regulation: "de-identified" (presumed to be beyond the risk of re-identification and therefore not regulated) and not fully identifiable, "limited data sets" (incomplete data which includes some identifiers, for example: birth dates). While the Rule's current categories may seem simple, The Health Privacy Project notes that a "one-size-fits-all de-identification approach" does not, one the one hand, meet the diverse data needs of researchers and health providers, nor does it, on the other hand, provide sufficient protections in era of evolving data technologies.

Reference:

The Health Privacy Project, Center for Democracy & Technology. Encouraging the use of, and rethinking protections for de-identified (and “anonymized”) health data. Center for Democracy & Technology, June 2009. http://www.cdt.org/healthprivacy/20090625_deidentify.pdf

Related:

Knoppers BM, Saginur M. The Babel of genetic data terminology. Nat Biotechnol. 2005 Aug;23(8):925-7. PubMed PMID: 16082354.

Sharyl J. Nass, Laura A. Levit, and Lawrence O. Gostin, Editors; Committee on Health Research and the Privacy of Health Information: The HIPAA Privacy Rule; Institute of Medicine. Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, D.C.: Institute of Medicine, The National Academies Press, 2009. http://www.nap.edu/catalog.php?record_id=12458

Other Stories in the News

Your Genes Aren’t Covered for That: One Year Later, Gaps in Genetic Discrimination Legislation Reveal the Challenges Ahead. Susannah Baruch, Science Progress. June 29, 2009.

FDA’s Current Ability to Regulate Genetic Testing Is Problematic, FDLI-AAAS Colloquium Attendees Say. Food and Drug Law Institute (FDLI) and the American Association for the Advancement of Science (AAAS) [Press Release]. June 22, 2009. http://www.fdli.org/press/pressrelease/062209.pdf

New Comparative Effectiveness Bill Enhances Dx, Genomics Focus. Matt Jones, GenomeWeb. June 18, 2009.

The GINA Law: Consumer Protection in a New Era of Genetic Testing Research Report. N. Lee Rucker, M.S.P.H., AARP Public Policy Institute, May 2009. http://www.aarp.org/research/health/prevention/fs156_gina.html

-- J.O.

In the Literature: Predictive Health 2.0

noreply@blogger.com (PredictER) — Wed, 17 Jun 2009 13:50:00 -0700

The recent double issue of The American Journal of Bioethics (Vol 9 6&7) includes two target articles (followed by open peer commentaries) on the ethical issues of direct-to-consumer (DTC) genomics and social networking.

The issue opens with an editorial by 23&Me's Andro R. Hsu, Joanna L. Mountain, Anne Wojcicki, and Linda Avey: "A pragmatic consideration of ethical issues relating to personal genomics." The editorial offers five points of discussion that the authors find relevant to the discussion of the ethical issues. Facebook users might be surprised to discover that the service is offered as an example of innovative data sharing policies; see point five: "A single data sharing policy cannot fit the needs of all".

The first "target article" reports the result of an attitudes survey about DTC; see: McGuire AL, Diaz CM, Wang T, Hilsenbeck SG. Social networkers' attitudes toward direct-to-consumer personal genome testing. Although the title suggests that "social networkers" are a focus of the article, in reality they are a convenient (or experimental?) survey population--the authors used Zoomerang and Facebook to reach the 1,080 respondents. Of the respondents, 47% reported a pre-existing knowledge of DTC genomics companies like 23&Me, Navigencs, and deCODEme; 6% reported having used one of these services and 64% reported a willingness to use one of the services in the future.

The second "target article" focuses on where all this might be leading; see: Lee SS, Crawley L. Research 2.0: social networking and direct-to-consumer (DTC) genomics. In addition to proposing that social network analysis could be used to explore the impact of these DTC genomics ventures on research, data sharing, and subject recruitment, the authors also ask: "What are the ethical and social implications of new social formations created through the sharing of personal genomic information?" In other words, how will the convergence of Web 2.0 and personal genomic information (PGI) change our social structures?

Commentaries on these articles include a few authored by friends of the PredictER program; see, for example:

Esposito K, Goodman K. Genethics 2.0: phenotypes, genotypes, and the challenge of databases generated by personal genome testing. pp. 19-21.

Caulfield T. Direct-to-consumer genetics and health policy: a worst-case scenario? pp. 48-50.

Other articles and publications of interest:

Genetic privacy and piracy. Nat Cell Biol. 2009 May;11(5):509. PubMed PMID:19404329.
Avard D, Silverstein T, Sillon G, Joly Y. Researchers' perceptions of the ethical implications of pharmacogenomics research with children. Public Health Genomics. 2009;12(3):191-201. PMID: 19204423.

Bombard Y, Veenstra G, Friedman JM, Creighton S, Currie L, Paulsen JS, Bottorff JL, Hayden MR; Canadian Respond-HD Collaborative Research Group. Perceptions of genetic discrimination among people at risk for Huntington's disease: a cross sectional survey. BMJ. 2009 Jun 9;338:b2175. PMID: 19509425.

Borry P, Howard HC, Sénécal K, Avard D. Health-related direct-to-consumer genetic testing: a review of companies' policies with regard to genetic testing in minors. Fam Cancer. 2009 Jun 2. PMID: 19488835.

Dokholyan RS, Muhlbaier LH, Falletta JM, Jacobs JP, Shahian D, Haan CK, Peterson ED. Regulatory and ethical considerations for linking clinical and administrative databases. Am Heart J. 2009 Jun;157(6):971-82. PMID: 19464406.

Forsberg JS, Hansson MG, Eriksson S. Changing perspectives in biobank research: from individual rights to concerns about public health regarding the return of results. Eur J Hum Genet. 2009 May 27. PMID: 19471310.

Goddard KA, Duquette D, Zlot A, Johnson J, Annis-Emeott A, Lee PW, Bland MP, Edwards KL, Oehlke K, Giles RT, Rafferty A, Cook ML, Khoury MJ. Public awareness and use of direct-to-consumer genetic tests: results from 3 state population-based surveys, 2006. Am J Public Health. 2009 Mar;99(3):442-5. PMID: 19106425.

Henrikson NB, Bowen D, Burke W. Does genomic risk information motivate people to change their behavior? Genome Med. 2009 Apr 2;1(4):37. PMID: 19341508.

Maliapen M. Clinical genomics data use: protecting patients privacy rights. Studies in Ethics, Law, and Technology. 2009;3(1):Article 1. Available at: http://www.bepress.com/selt/vol3/iss1/art1

Manion FJ, Robbins RJ, Weems WA, Crowley RS. Security and privacy requirements for a multi-institutional cancer research data grid: an interview-based study. BMC Med Inform Decis Mak. 2009 Jun 15;9(1):31. PMID: 19527521.

Mascalzoni D, Hicks A, Pramstaller PP. Consenting in population genomics as an open communication process. Studies in Ethics, Law, and Technology. 2009;3(1):Article 2. Available at: http://www.bepress.com/selt/vol3/iss1/art2

Rogowski WH, Grosse SD, Khoury MJ. Challenges of translating genetic tests into clinical and public health practice. Nat Rev Genet. 2009 Jun 9. PMID: 19506575.

Wilkinson RH. The single equality bill: a missed opportunity to legislate on genetic discrimination? Studies in Ethics, Law, and Technology. 2009;3(1):Article 3. Available at: http://www.bepress.com/selt/vol3/iss1/art3

Gene Patents on the Radio

noreply@blogger.com (PredictER) — Wed, 10 Jun 2009 12:59:00 -0700

Do you own your genes? Should you have a stake in the profits from gene-related products based on "your" genes? What about the "tens of thousands of patents" issues by the U.S. Patent and Trade Office for gene-related products? If you're interested, Rebecca Roberts discusses Patenting Genes with Joshua D. Sarnoff, Hans Sauer, and Shobita Parthasarathy on The Kojo Nnamdi Show (WAMU 88.5 FM, June 4, 2009.)

Listen to the full show online or read a summary Donald Zuhn's summary, "Gene Patenting Debate Continues" (Patent Docs, June 9, 2009).

Genetic Testing and Privacy: Are Our Health Care Policies Adequate?

noreply@blogger.com (Amy Lewis Gilbert) — Wed, 29 Apr 2009 07:10:00 -0700

As a genetics professional who provides genetic testing, I am aware of the fact that many individuals contemplating genetic testing cite insurance and employment concerns as major reasons to forego testing. For that reason, I heaved a sigh of relief on May 21, 2008 when the Genetic Information Non-Discrimination Act (GINA) was signed in to law. First introduced in 1995, at a time when only about 300 genetic tests were currently in use and these for mainly rare diseases, it was called both forward-thinking and premature. Now hailed as the first civil rights law of the new century, GINA will prohibit group and individual health insurers from using a person’s genetic information in determining eligibility or premiums and prohibit employers from using a person’s genetic information in making employment decisions such as hiring, firing, job assignment, or other terms of employment. Guidelines for segregating genetic information from other medical records are expected to be forthcoming.

As I thought more about it, however, I realized that the world has changed rapidly in the 14 years since this bill was first introduced, and that these changes may well undermine the protections that GINA was meant to provide. I see four main threats: 1) more genetic information everywhere, 2) data expansion, 3) genome wide association studies, and 4) electronic medical records.

Under the more information heading, the terms “Genetic information” and “genetic condition” are becoming more difficult to define. We are finding that almost all illness has some genetic component such that making clear distinctions between genetic and non-genetic health information is becoming increasingly meaningless. Under the data expansion category, genetic research has shifted from diseases linked to a single gene (Huntington disease, cystic fibrosis) to more common and complex illnesses characterized by the interactions of multiple genes and environmental factors (asthma, diabetes). There are now over 1500 genetic tests in use and in the not-so-distant future, nearly all health records will include substantial genetic information. Genome Wide Association Studies (GWAS) look for single changes in the hundreds of thousands of base pairs (A,T,C,G) that make up the human genome associated with a particular illness or condition. These conditions may be as serious as breast cancer or as frivolous as what type of ear wax you are prone to develop. These tests are being aggressively marketed directly to consumers and can be ordered on line for less than $400. There is little oversight of the companies marketing these tests and as one who works in the field of genetics, it seems almost criminal to test for one mutation associated with cystic fibrosis out of the more than 1000 known CF mutations and call that information useful in the absence of extensive educational efforts. It may not be long before our patients come to our offices with their printouts from 23&Me and ask to add them to their medical record. The fourth threat may be the shift from paper-based medical records to electronic health records (EHR) with their goal of standardization, compatibility, and ease of transport. In a paper-based system, the greatest protection of individual privacy is chaos, the inability to aggregate a complete record from multiple providers over time. Comprehensive and longitudinal medical records will inevitably contain sensitive information and patients will no longer have the option of selective recall in the sense of “is that depressive episode I experienced in graduate school after being mugged really relevant information for the orthopedist performing my knee surgery twenty years later?” Electronic medical records will make it even more difficult to sequester genetic information.

One other developing trend may also play a role, the refinement of personalized medicine, the ability to target drug therapies customized to each person’s genetic makeup to both improve the effectiveness of current treatments and to reduce side effects. Pharmacogenetic testing is becoming standard practice in selecting drugs and dosages for certain cancers while toxicogenetics, the use of GWAS studies to predict how individuals may respond to certain toxins, is becoming more important in assessing both individual and public health risks. If genetic factors appear to play a role in individual and/or community resistance to flu viruses, who knows what might happen.

Technology moves rapidly while our legislature does not. A bill introduced to fix a problem in 1995 may not be as relevant or as useful in 2009. So while I am still happy that GINA was finally passed, the devil, as they say, is in the details, and it remains to be seen how much protection is actually provided for our patients and their families.

Kimberly A. Quaid, Ph.D.

Consent & Conversation in Population-Based Research

noreply@blogger.com (Amy Lewis Gilbert) — Mon, 23 Feb 2009 10:44:00 -0800

PredictER's Peter H. Schwartz will be presenting the Walter C. Randall Lecture in Biomedical Ethics at the annual Experimental Biology meeting of the American Physiological Society, to be held in New Orleans, April 18-22, 2009. Dr. Schwartz's talk, Consent and Conversation in Population-Based Genetic Research, will take place on Tuesday, April 21st at 2:00 p.m. Additional information is available here.

Abstract: The future of research into the human genome depends on the creation of massive biobanks, databases that combine phenotypic information about individuals (such as their medical history) with genetic information and biologic samples collected from them. Some of the most important biobanks will involve the participation of thousands or millions of people, representing a broad swath of an entire community. But signing up such large numbers raises serious challenges for traditional ideas of consent by research subjects. We need to formulate a new model of ethical research that relies on a conversation with a community rather than just informed consent by individuals.

Amy Lewis Gilbert

Long Term Outcomes of Presymptomatic Testing in Huntington Disease

noreply@blogger.com (PredictER) — Tue, 17 Feb 2009 06:18:00 -0800

Huntington disease (HD) is a late onset autosomal dominant neuropsychiatric disorder. Symptoms include a movement disorder, mood disturbances and dementia. The average age of onset is approximately 40 years of age and if one of your parents is affected with the disease, you have a 50% chance of having inherited the genetic mutation that causes HD. Men and woman are equally affected.

In 1993, the genetic mutation that causes Huntington Disease was discovered. This discovery meant that direct genetic testing for the presence or absence of the HD mutation could be offered. Testing is usually offered within a multidisciplinary framework including geneticists, neurologists, psychologists, nurses and social workers and within a testing protocol that involves a neurological examination, pretest counseling, results in person and available follow-up. Estimates indicate that in Europe, less than 20% of individuals at risk for HD takes the test. Estimates for the United States suggest that the uptake of testing is even lower. The lack of a cure for HD, or a treatment that can delay the onset or slow the progression of the disease, is likely a major factor in the low uptake of testing.

Recently, in some HD circles, there have been calls to increase the number of individuals getting tested in order to have a cohort of gene positive individuals ready to participate in future clinical trials. This desire to increase the number of individuals tested is, in my opinion, wrong headed for many reasons, but a recent paper on the long term effects of testing also suggests that caution is in order.

In February of 2009, the European Journal of Human Genetics published a paper examining the long term impact of presymptomatic testing for Huntington disease. The authors interviewed 119 (57 gene carriers and 63 non-carriers) asymptomatic individuals after an average delay of 3.7 years after they received their genetic test result. The main outcomes of interest in the paper were social and psychological adjustment after testing (1).

The results were as follows: The overall scores for social adjustment were similar in carriers and non-carriers and were in the normal range for both groups. Carriers were not more anxious than non-carriers, but current depression was significantly more frequent in the carriers. Prior to testing, there were no differences in the number of carriers and non-carriers who had experienced a depressive episode. After testing, however, the percentage of carriers experiencing depression rose from 42% to 49% while the percentage of non-carriers experiencing depression fell from 45% to 31%. Perhaps even more important is the fact that carriers had significantly higher scores than non-carriers when evaluated with the Beck Hopelessness Scale, considered to be a measure of suicidality. Of note is the fact that while there was one suicide attempt and one hospitalization for major depression after testing in the carrier group, three non-carriers also attempted suicide, one was hospitalized for depression and one hospitalized for a psychotic episode. Despite this evident distress, only 31% of the carriers and 15% of the non-carriers were under psychiatric care and only 36% of the carriers and 15% of the non-carriers were under treatment with antidepressant or anti-anxiety medications. Further investigation indicated that the best predictor for the occurrence of depression after taking the test was the presence of a previous depressive episode. In other words, individuals who have experienced depression prior to testing are more likely to experience depression after testing. Finally, when asked to rate the current impact of the test results on their lives, carriers gave a more negative rating than non-carriers and reported that they had less ability to cope with the test results than non-carriers. Again, it is important to note that more than 25% of the non-carriers reported difficulty coping with the test result.

It is possible to compare these results with a previous study looking at long term outcomes 7-10 years after testing (2). This study of 142 tested individuals and their partners found that carriers and their partners were more distressed immediately after the test. Their outlook appeared to improve somewhat in the 2-3 year post test period but became more negative as the age of onset approached. This study also found that carriers who were lost to follow-up reported more pretest distress than did those carriers who participated in the follow-up study. This finding, which reflects both my own experience and the anecdotal experience of other test center directors, is important because it suggests that most studies examining the impact of testing may tend to underestimate the amount of distress that is being experienced by those who have been tested.

So what do these results tell us? In the 2009 study, almost half of the carriers where experiencing depression after testing. However, almost a third of non-carriers were also experiencing depression. At least two studies have suggested that it might take up to five years for non-carriers to experience a positive change in their quality of life after receiving a favorable test result (3,4). One explanation that has been given is that it takes this long to resolve the emotional state of mourning for the loss of being at risk and the end of doubt about one’s genetic status. Others have hypothesized that that non-carriers may be experiencing 1) survivor guilt for not having the HD gene when others in the family might 2) regret for life decisions made in the past as a function of being at risk, 3) inability to leave behind the at risk mind set, 4) inability to truly believe the test results, and 5) negative reactions on the part of family members (1).

Whatever the explanation, these results indicate that individuals at risk, carriers and non-carriers alike, may be a vulnerable population and that it is particularly important to assess and treat depression before testing and to provide psychological support and psychiatric care after testing. These results also suggest that the decision to be tested should not be made lightly and that the impact of testing may last a long time after results are given.
References:

1. Gargiulo M, Lejeune S, Tanguy ML et al, (2009). Long-term outcome of presymptomatic testing in Huntington disease. European Journal of Human Genetics, 17:165-171.

2. Timman R, Roos R, Maat-Kievet A, and Tibben A. (2004) Adverse effects of predictive testing for Huntington Disease underestimated: Long term effects 7-10 years after the test. Health Psychology 23:189-197.

3. Decruyenaere M, Evers-Kiebooms G, Cloostermans T et al. (2003) Psychological distress in the 5-year period after predictive testing for Huntington disease. European Journal of Human Genetics 11:30-38.

4. Almqvist EW, Brinkman RR, Wiggins S, Hayden MR (2003) Psychological consequences and predictors of adverse events in the first 5 years after predictive testing for Huntington disease. Clinical Genetics 64: 300-309.

Kimberly A. Quaid, PhD

Will electronic medical records threaten my privacy? No, but…

noreply@blogger.com (PredictER) — Sat, 07 Feb 2009 12:29:00 -0800

I’ve been thinking a lot about privacy lately. For example, among the ways President Obama has indicated his commitment to a 21st century health care system, is “by computerizing medical records … saving countless lives and billions of dollars.”

His proposal is already underway in many communities around the country, including Indianapolis, whose Regenstrief Institute is a nationally recognized leader in the development and diffusion of electronic medical records [EMRs]. The conversion of millions of paper records to electronic records, and the organization of hospitals and physician groups to agree on how best to access and share these records, presents a number of logistical and technical challenges. None of these are insurmountable. Moreover, given sufficient resources and political will, it is likely that the President’s vision can be translated into reality sooner rather than later – so long as we can figure out how to handle the elephant in the room (and no, this is not the Republican caucus). The elephant is privacy – the idea that access to personal health information is something that we as individuals should be able to completely control, and that access by others (especially unauthorized third parties) constitutes a serious breach of personal space, let alone any negative repercussions from malicious use. But does the move to EMRs require a dramatic change in the ethics of privacy? Should people be more worried once their records are accessible to more health providers? How can they be sure that errors will be quickly corrected?

I thought I had completely settled views on these questions: namely that the risks from privacy invasion are potentially serious and people are entitled to be frightened. In the case of my personal health information, I have confidence that those experts working on the architecture for the system – the checks and balances, the encryption techniques, gateways, passwords, algorithms and who knows what else – will construct it with exactly those worries in mind. Interestingly, I’m more upset right now that in the past few days someone with plenty of time on their hands has figured out a way to upload a picture of me from the internet and create a brand new Facebook page using my name. This is creepy and it’s wrong. Should I be more worried about a breach in my electronic medical record that accidentally discloses to the world that Eric Meslin suffers from migraines (true by the way), or the Facebook hacker who convinces unsuspecting people to become “friends of Eric Meslin” in order to expose them to “wall-to-wall” postings that attribute opinions about privacy to me which aren’t my own?

--Eric M. Meslin

New Technologies and Old Laws: Square Pegs in Round Holes

noreply@blogger.com (Amy Lewis Gilbert) — Wed, 21 Jan 2009 08:23:00 -0800

I sit in a lot of meetings where I people discuss how new health information and technology will fit into existing policy and law. Many of these discussions go over my head, as they are bogged down in minutiae of law and policy far beyond my ken. I have often assumed that these discussions are important, perhaps even necessary, as our system of law is built on precedent, reaching back into the past to inform the future.

And then I read something like this.

New President Barack Obama will have to give up his Blackberry. The entire White House Staff can’t Instant Message. Eight years ago, President Bush sent a message to 42 friends and relatives right before assuming office explaining that he had to give up email. I know what I will say to them if they ever try to come for my iPhone; it’s not fit for print and involves my cold, dead fingers.

Why? It has to do with something called the Presidential Records Act. It turns out that all of the documents that come into contact with a President and Presidency need to be preserved and one day made public. Don’t get me wrong, I understand the importance of such a law, and I am all in favor of it. But even that law recognized that there had to be exceptions. Presidents, and their staff, do need to keep some things private. Conversations aren’t all recorded; neither are telephone calls.

Personally, I hate to talk on the phone. So, given the chance, I will use email, text messaging, or even Instant Messaging to talk to friends and colleagues. For me, and many others, it’s faster, it’s easier, and it’s preferable. I can tell you that I would be much less productive professionally, and much less happy personally, if you told me I had to stop.

Here’s the problem. The Presidential Records Act was written in 1978. No Blackberries. No Instant Messaging. No email. It is simply ridiculous that President Obama can’t have a Blackberry and David Axelrod can’t Instant Message because of a law written thirty years ago. We shouldn’t have to figure out how to make these new technologies fit into law that couldn’t predict them. We need new law.

Which brings us back to health technology. Those old laws and old policies – they too were often written in a time when the issues and difficulties we face today were simply incomprehensible.

It may be just as unreasonable to think that we can use them to inform what we should do today. Sometimes, precedent isn’t enough.

We shouldn’t have to figure out how to make these new technologies fit into policies that couldn’t predict them. We need new policies.

Aaron E. Carroll

Ethics and Health Information Technology: Kenneth W. Goodman, PhD

noreply@blogger.com (PredictER) — Thu, 15 Jan 2009 08:56:00 -0800

Join us on January 29th from 12 - 1 PM for Kenneth W. Goodman's discussion: "Ethics and Health Information Technology: New Challenges in Clinical Care and Research in a Pharmacogenomic World" [Flyer, 71 KB - PDF ]

In addition to being a widely recognized expert on the ethical issues of information technology, Goodman is co-director of the University of Miami’s Ethics Programs and founder and director of its Bioethics Program and Pan American Bioethics Initiative. The Ethics Programs have recently been designated a World Health Organization Collaborating Center in Ethics and Global Health Policy, one of four such centers in the world and the only one in the United States.

Goodman notes, in an abstract for this presentation, that the intersection of ethics, computing, and medicine is transformative. He expects "this transformation will continue and acquire greater urgency in a post-genomic, evidence-based world, as digitized genetic data introduces new challenges for clinicians, researchers and policy makers."

This is truly a timely topic; so, join us in Room 1110 of the HITS Building, 410 W. 10th Street, Indianapolis, Indiana. - J.O.

Personalized Medicine: PredictER Collaborator Featured in NY Times

noreply@blogger.com (Amy Lewis Gilbert) — Mon, 12 Jan 2009 11:41:00 -0800

David A Flockhart, MD, PhD, Division Chief of the IU Department of Medicine’s Division of Clinical Pharmacology and PredictER Collaborator, was featured in a December 29th New York Times article that is part of a compelling series examining steps taken toward medicine based on evidence. The article, Patient’s DNA May Be Signal to Tailor Medicine, provides a highly readable overview of personalized medicine, illustrates the field’s inherent potential to increase positive outcomes and decrease costs, and then discusses some of the conundrums that genetically-tailored medicine presents. The author, Andrew Pollack, uses the outcomes of Flockhart’s extensive tamoxifen research to aptly illustrate the medical promise of genetic testing and its broader implications. Flockhart’s research demonstrates that a particular enzyme, CYP2D6, is responsible for converting tamoxifen into a different substance, called endoxifen, which is then directly responsible for fighting breast cancer. The CYP2D6 gene, however, varies between people such that the mechanism is inactive in about 7% of the population, and only moderately active in 20-40%. As the article points out, most patients are now treated with a more expensive class of drugs that demonstrated greater efficacy in clinical trials conducted before the role of CYP2D6 was fully understood. For those women with active CYP2D6, however, tamoxifen may well be the better alternative for the patient, both medically and economically. Genetic testing to determine gene activity in this scenario may therefore have vast economic implications for the pharmaceutical industry.

Amy Lewis Gilbert

Predictive Health, Insurance & Security: A Spiritual Perspective

noreply@blogger.com (PredictER) — Thu, 18 Dec 2008 07:05:00 -0800

Over the last few days, I have heard two discussions – one on the radio and the other at the Indiana University Center for Bioethics – that have given me a new and deeper understanding of the meaning of health insurance and of the challenges of incorporating Predictive Health information into healthcare. These two presentations came together to give me a new understanding of the spiritual dimension of health insurance.

The first discussion occurred on the NPR program "Speaking of Faith," hosted by Krista Tippett. This week the program featured an interview with Parker Palmer, a Quaker writer and educator, and focused on themes related to the current economic meltdown. When discussion turned to the role of greed in causing the crisis, Palmer commented that greed stems at least partly from a sense of isolation and a lack of feeling of being part of a community. If a person feels that he cannot rely on others for help at times of need, he will understandably develop the impulse to acquire as much as possible, to attempt to amass a sort of fortress against possible danger to him and his family.

This immediately reminded me of the state of healthcare and health insurance in this country. As premiums rise and increasing numbers of businesses cut back on health insurance for employees and retirees, more and more Americans are living without health insurance or facing the very real possibility of this. And what could cause a greater feeling of isolation – of living without support from others – than finding yourself without available or affordable health insurance? Even those of us who do have health insurance must feel insecure as we observe the growing ranks of uninsured and underinsured people. The historic economic downturn has made the trend only worse, of course.

Palmer’s comment highlights one of the many destructive effects of fearfulness. And it highlights the importance of making health insurance available and affordable. In short, universal health insurance, in my view, would play a significant role in helping to combat the feeling of isolation and helplessness that many feel in the current situation.

And here’s where Predictive Health information comes into the picture. Predictive Health Research (PHR) promises to provide new ways to identify individuals’ specific level of health risk and provide new, more targeted medical care. A healthcare system that provided excellent preventive care, guided by breakthroughs in PHR, could greatly reduce mortality and morbidity. We could improve the sense of safety and trust that supports a healthy spiritual life. But here’s where the fly lands in the ointment. At our biweekly meeting of the PredictER program this week at the IU Center for Bioethics, Eleanor Kinney JD, MPH, and Jennifer Girod JD, PhD, RN, presented a talk about the ways that Predictive Health information threatens to undermine the current system of health insurance. In short, identifying people’s risk levels creates perverse incentives for patients and for insurance companies. Individuals with lower risk have less reason to join the insurance “pool,” since their premiums disproportionately support care for others, rather than themselves. At the same time, insurance companies have the incentive of excluding those at higher risk, or at least charging them higher premiums. As Kinney and Girod pointed out, there are various schemes for blocking this destructive dynamic, although things get difficult pretty fast.

But sitting there listening to them, I realized that once again we were talking about the challenge of how to bind us together as a society and take care of everybody – the high risk and the low risk alike. How tragic if the same scientific breakthroughs that could allow for improved preventive care for all were to result in worse care and isolation for those at the highest risk. That would truly be a situation where isolation, not trust and community, would have its day.

Peter Schwartz, MD, PhD

Translational Medicine, Cancer and Biobanks: Predictive Health Ethics Events at IU

noreply@blogger.com (PredictER) — Fri, 28 Nov 2008 09:47:00 -0800

On December 1-2, 2008 the Indiana Health Industry Forum will present From Basics to Bench to Bedside: Emerging Trends and New Developments in Cancer Discovery, Diagnosis and Treatment. The purpose of this summit, the third in a series, is to examine the state of life sciences research in Indiana with a diverse range of individuals and institutions interested in cancer research, diagnosis and treatment. Of particular interest to those keen on predictive health is a panel discussion on December 2nd at 1:00 PM entitled “Tailored Therapeutics and Implications for Regulatory Endpoints.” Panelists include Jerome Yates, MD, MPH, National Vice President for Research at the American Cancer Society, Eric Meslin, PhD, Director of the Indiana University Center for Bioethics (IUCB), Lawrence Lesko, PhD, FCP, Director of the Office of Clinical Pharmacology at the FDA’s Center for Drug Evaluation and Research, and Silvana Borges, MD, Medical Officer for the Genomics Group of the same.

On December 4, 2008 the Indiana Clinical and Translational Sciences Institute and IU Simon Cancer Center are hosting a symposium entitled Biorepositories: Scientific, Technical and Ethical Considerations at the Cancer Research Institute on the Indiana University – Purdue University Indianapolis campus. IUCB Faculty Investigator Jennifer Girod, JD, PhD, RN, will be giving a talk on “Ethical and Legal Considerations in Biobanking.” Other presentations will address issues specific to the storage of biospecimens, the extraction and processing of RNA and DNA, tissue procurement, the impact of storage conditions on DNA, and the benefits of biorepositories to research.

On December 8- 9, 2008 the Indiana University School of Medicine will be holding an event that addresses the FDA in the 21st Century: Issues and Their Impact on Medical Technology. This event, which will focus on the future role of the FDA in a changing market, is part of the medical school’s Medical Technology Leadership Forum [Flyer - PDF]. IUCB Director Eric Meslin, PhD, will be moderating a morning session on December 9th specific to ethics and conflicts of interest with Ora Pescovitz, MD, President and CEO of Riley Hospital for Children and Elazar Edelman, MD, PhD, Director of the Harvard-MIT Biomedical Engineering Center. – Amy Lewis Gilbert

Genetic Privacy: T.J. Maxx and the NIH

noreply@blogger.com (PredictER) — Tue, 25 Nov 2008 07:45:00 -0800

What do T.J. Maxx, the V.A. and NIH have in common? They have all been involved in handling personal data in such a way that individual privacy and confidentiality may have been violated. In December 2006 the financial information of over 40 million customers of T.J. Maxx and Marshall’s was accessed by a hacker potentially exposing customers to identity theft. Also in 2006, a laptop computer containing personal information including names, addresses, dates of birth and social security numbers for 38,000 veterans went missing. This past August, large amounts of aggregate human DNA data that the National Institute of Health and other groups had made open to researchers around the world was removed from public view due to privacy concerns. The reason behind this removal was a study (doi:10.1371/journal.pgen.1000167) released by the Translational Genomics Research Institute and the University of California showing that using an algorithm and a microarray a curious individual could possibly identify whether or not an individual’s DNA was in a genome wide association study (GWAS) database.

Why does this matter? NIH and other groups conducting GWA studies know that one of the core ethical components of their work, and a critical element for convincing people to participate in these studies, is being able to promise that their personal medical and genetic information will not be compromised and will never be used in such a way that might cause them harm. Being able to demonstrate, for example, that a representative of law enforcement armed with a DNA sample from a crime scene could search an existing NIH database for a sample match and be successful, undermines this promise in a way that might give us all pause. Researchers will still have access to the data, but they will now have to apply for access to the data and agree to protect the confidentiality of the data.

As researchers strive to use the information gained by the Human Genome Project for the improvement of health care and the prevention and treatment of disease, more and more of us will be asked to participate in efforts to establish enormous databases of our genotypic (DNA) and phenotypic (medical records) information. I still shop at Marshall’s, but I am not sure I will be giving my DNA anytime soon. --Kimberly A. Quaid

Patient Attitudes Toward Genotyping: Willingness to Donate

noreply@blogger.com (PredictER) — Mon, 17 Nov 2008 07:00:00 -0800

The November 2008 issue of Obstetrics & Gynecology included an article addressing an Indiana University study which sought to ascertain the willingness of women to donate DNA specimens. The article, “Patient Attitudes Toward Genotyping in an Urban Women’s Health Clinic” (David M. Haas, Jamie L. Renbarger, Eric M. Meslin, Katherine Drabiak, and David Flockhart), acknowledges the great promise of the emerging fields of genotype association studies and pharmacogenetics, which will theoretically allow for targeted medical interventions, personalized drug therapies and the more efficient allocation of healthcare resources. The study compared women’s willingness to donate DNA specimens via blood and saliva collection, and looked at several other factors to confirm the findings of previous studies regarding which of those factors predicate a willingness to donate. The authors found that more women are willing to donate DNA using saliva than blood, and that higher levels of education (college and beyond) and greater knowledge of genes and DNA increase women’s willingness to donate.

So how do these findings translate into ethical practice? How will they inform the future collection of samples for both medical and research purposes? It seems that researchers and practitioners should bear in mind that less-invasive methods of DNA procurement are preferred, and that education about purpose and use be stressed during the informed consent process. When asked about the translational implications of this study, Dr. Eric Meslin, co-author and Director of the Indiana University Center for Bioethics, said: “the key to success in any biobanking effort lies in the scientific community’s ability to both acquire and maintain the public’s trust. Informed consent may be evidence of the public’s willingness to permit specimens to be used for research, but consent should never be confused with the public’s willingness to trust science to do the right thing.” -Amy Lewis Gilbert

Genetic Testing and Personalized Drugs: PredictER at Spirit and Place

noreply@blogger.com (PredictER) — Fri, 07 Nov 2008 11:29:00 -0800

As part of the 2008 Spirit & Place Festival, a panel of experts from the Indiana University Center for Bioethics and the Indiana University School of Medicine will join together to illustrate the complex intersection of ethics, medicine and science. Dr. Eric M. Meslin, director of the Center for Bioethics; Dr. Kimberly A. Quaid, professor of medical and molecular genetics; and Dr. David Flockhart, chief of the division of clinical pharmacology, will present Imagining Our Medical Future: The Ethics of Predictive Genetic Testing and the Search for Personalized Drugs this Sunday, November 9th, 2:00-4:00 p.m. at the Indiana Medical History Museum, 3045 W. Vermont Street, Indianapolis. Free tours of the museum will be available both before and after the panel discussion. More information regarding the Spirit & Place Festival, which is runs now through November 16th, is available at www.spiritandplace.org - ALG

Genetics, Ethics, and Tasmania

noreply@blogger.com (PredictER) — Wed, 29 Oct 2008 12:56:00 -0700

If you're in the Indianapolis, Indiana area on November 10th, join us at the IU Center for Bioethics with Mark Stranger, Ph.D., from the University of Tasmania. Our guest will be delivering a talk on Genetics, Ethics and the Law Down Under: A Tasmanian Perspective from 3:00-4:00PM in the HITS Building, Suite 3100 [Flyer - PDF 74 KB]. Dr. Stranger, a sociologist with expertise in risk assessment, social change, biobanking and social research methodologies, is a Senior Research Fellow and Executive Director for the Centre for Law and Genetics at the University of Tasmania. He also manages the Centre’s multidisciplinary and international Biotechnology, Ethics, Law and Society Network.

This event will be convened by the Indiana University Center for Bioethics; IUPUI Consortium for Health Policy, Law and Bioethics; and the IUPUI Office of International Affairs. - ALG

PredictER News Brief - Published Today

noreply@blogger.com (PredictER) — Tue, 14 Oct 2008 12:15:00 -0700

The most recent edition of PredictER News Brief is now online. PredictER News Brief provides a digest of news and research relevant to the ethical, legal and social implications of predictive health research. Join the PredictER News Brief listserv or view past issues in the archive.

The October 14th edition includes links to stories related to deCODE's new genetic test to screen for breast cancer risks and (as always) a list of recent journal articles on the ethical issues of predictive health and genetic research. Including:

Alpert S. Privacy issues in clinical genomic medicine, or Marcus Welby, M.D., meets the $1000 genome. Camb Q Healthc Ethics. 2008 Fall;17(4):373-84.
[View abstract or record.]

Goodman KW and Cava A. Bioethics, business ethics, and science: bioinformatics and the future of healthcare. Camb Q Healthc Ethics. 2008 Fall;17(4):361-72.
[View abstract or record.]

Hogarth S, et al. The Current Landscape for Direct-to-Consumer Genetic Testing: Legal, Ethical, and Policy Issues. Annu Rev Genomics Hum Genet. 2008 Sep 22;9:161-182.
[View abstract or record.]

Singer E, et al. Trends in U.S. Attitudes Toward Genetic Testing, 1990-2004. Public Opin Q. 2008 September 1, 2008;72(3):446-458.
[View abstract or record.]

Wallace S, et al. Governance mechanisms and population biobanks: building a framework for trust. GenEdit. 2008;6(2):1-11.
[View abstract | PDF]

What do you mean by "race"? A call for standards and empirical ethics research.

noreply@blogger.com (PredictER) — Thu, 18 Sep 2008 11:21:00 -0700

You've probably read an article or two that reports the results of a race-based investigation. Perhaps it was a study of health disparities, a survey of patient attitudes, an examination of a race-based intervention or new medication to be marketed to a specific race-based demographic. If you wanted to do a systematic review of these papers, you might be vexed by the difficulty of finding a common, valid definition of "race". As a socially-constructed category, defining the limits of race and ethnicity is a slippery business and one that has a problematic past in the history of science and medicine. With this in mind, Vural Ozdemir, Janice E. Graham and Beatrice Godard make a call for clarity in "Race as a variable in pharmacogenomics science: from empirical ethics to publication standards" (Pharmacogenet Genomics. 2008 Oct;18(10):837-41. - PubMed CiteULike). The authors argue for the use of empirical ethics research to inform the development of new publication standards to "minimize the drift from descriptive to attributive use of race in publications". In this context, empirical ethics, or "applied social science methodologies … to better understand, for example, the 'lived' experiences of user groups", would identify blind-spots in predictive health research and would help researchers, regulators, policy-makers, and editors "differentiate between an imprecise (yet measurable) predictive biomarker, from a construct such as race".

Given the uproar around BiDiL and other race-based pharmacogenomic ventures, the authors have made a timely, if not over-due, call for publishers and ethics researchers to collaborate in developing standards for the use of the controversial category in published research. - J.O.