Community Roundtable, April 9: Biobanking 101: What are they and how can the public participate?

If you're in central Indiana this coming April, you might want to attend a community event on biobanks. PredictER's Eric M. Meslin will be directing a roundtable discussion on biobanks on April 9 from 11:30 a.m. to 1 p.m. at the Indiana Historical Society, 450 W. Ohio St.

This event is sponsored by The Fairbanks Institute for Healthy Communities and the Indiana Clinical and Translational Sciences Institute Community Health Engagement Program.

Eric M. Meslin, PhD, is director of IU Center for Bioethics and associate dean for bioethics at the IU School of Medicine. He also co-directs the IU Center for Law, Ethics and Applied Research in Health Information and directs the Indiana CTSI Bioethics and Subject Advocacy Program.

Parking is free and lunch will be provided. To register, visit redcap.uits.iu.edu/surveys/?s=g6M4FP.

For more information, see the event flier.

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

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

IndyStar - Do you want to know? Direct-to- consumer DNA tests ...

PredictER's Kimberly Quaid and Indiana University Department of Medical and Molecular Genetics' Dr. Gail Vance comment on direct-to-consumer genetic testing in today's issue of The Indianapolis Star. Quaid notes:

"For a lot of genetic conditions, there is not much we can actually do to change them. So, what are people getting out of the tests?" … While legitimate genetic tests exist, such as one to detect the BRAC mutations for breast cancer, Quaid said, she doesn't see the sense in identifying risks for every disease. She also doubts the validity of tests used by some firms. … Traditionally, health-related genetic tests have been available only through health-care providers, who decide whether they are based on family history and symptoms, and who interpret results for patients. Quaid said that method better safeguards consumers.

Biobanks for Breakfast

On April 25, 2008, a collection of community leaders, top medical researchers, and statewide biotech industry leaders met to discuss the bioethical and legal issues surrounding biobanks in Indiana. Biobanks are a growing resource in biotech research. They contain samples of human biological specimens and are often linked in varying degrees to the personal health and demographic information of the donor. Biobanks range from the very small disease specific collections of tissue to the very large national sponsored banks of several million specimens incorporating several different types of biological material from persons both healthy and with known disease. Ownership and commercial involvement are among the most difficult ethical issues in developing successful biobanks. The Bioethics for Breakfast group considered these issues along with Indiana’s role in future biobanking by asking attendees to think about the following questions:

- Are you willing to donate your DNA to a biobank for medical research?
- Are you comfortable allowing Indiana companies to profit by developing commercial products from your samples and donations?

Guest speakers at the event included:

David Flockhart, M.D., Ph.D. , Chief of the Division of Clinical Pharmacology at the Indiana University School of Medicine – Dr. Flockhart outlined the national and international status of biobanks.

Mervin C. Yoder, Jr., M.D., Richard and Pauline Klingler Professor: Department of Pediatrics, Indiana University School of Medicine – Dr. Yoder discussed the therapeutic use of biobank samples.

Andrew R. Klein, J.D., Paul E. Beam Professor of Law, Indiana University School of Law - Indianapolis – Prof. Klein led the group in discussion of the difficult ethical and legal issues.

The Bioethics for Breakfast series is co-sponsored by the Indiana University Center for Bioethics and the law firm of Sommer Barnard. – Patrick Barrett

Purdue Bioethics: Ethical Issues in Constructing and Using Biobanks

PredictER's Eric M. Meslin, PhD, Director, IU Center for Bioethics, will address the Purdue Bioethics lecture series this Wednesday, April 16th, from 6 to 7 pm. Meslin will provide an overview of the ethical issues in developing and using biobanks for genetic research. The Purdue lecture series (now in its second year) intends "to build opportunities for engagement between philosophy, policy, and science at a campus-wide level and to raise awareness of the ethical implications of biotechnological development for our environment both local and global". The current year's series focuses "on two central themes in bioethics: the ethical issues of climate change and those of issues in medical technologies". Read more about Meslin's lecture or to learn more about the series contact Jonathan Beever or Nicolae Morar at Purdue Bioethcs. Also see the international blog, BlogEthics Purdue.

Gene Sherpas for CME

Steve Murphy at Gene Sherpas: Personalized Medicine and You has often asserted that physicians will need continuing medical education to understand the latest advances in genetic research and to interpret clinical genetic information. In a recent post, however, he provides a few hints about what he will be doing to make these educational opportunities a reality. Murphy writes:

There is a new hope. An institution being set up by myself and others. We are currently looking for donors and we endeavor to set up educational events and group sessions. We will work with Corporate Genomics, Academic Genetics, Corporate Labs, Academic Medicine to develop training workshops. Interested?

Well Steve, I'm interested (obviously), PredictER has been working on continuing medical education programs for physicians with patients participating in genetic research. We have made plans to offer two initial programs in local clinics here in Indianapolis this summer—we hope to stream these programs to a wider audience as well. While this is one step removed from the clinical use of consumer genomics (we're really focusing on research ethics in the clinic), I hope that our work on the ethical issues of genetic medicine will be of use to your hoped for institution. At the very least, don't forget the ethicists and community advocates when designing your curriculum. Good luck finding donors and keep us posted! – J.O.

Racing for the Biobank

Here in Indianapolis the city is preparing for one of the biggest annual gathering of runners in the region. On April 19th thousands of runners and walkers will converge on the Indiana University-Purdue University, Indianapolis (IUPUI) campus for the The 2008 Komen Indianapolis Race for the Cure. While there will be plenty of people milling around after the 5k race and walk, many of the participants will also donate DNA and blood to a predictive health research study. The Susan G. Komen for the Cure Tissue Bank at the IU Simon Cancer Center will collect blood samples for the biobank from both women with and without a high risk for breast cancer. In a press release from the Indiana University School of Medicine, Dr. Susan Clare, a co-principal investigator of the tissue bank, notes that:

Collecting blood from women who have not had breast cancer provides an opportunity for these donors to give a unique gift to science …. Even though these donors will not benefit directly from their donation of blood, they are providing an invaluable resource to enable research that will benefit generations to come.

The upbeat tone in this quotation is nurtured by more than a keen eye for good public relations—past tissue bank drives at the race have been a wild success. So, is this a good way to build a predictive health biobank? Would similar outreach methods work for other diseases? How about a 5k race to cure for diabetes or schizophrenia? Would runners turn out in equal numbers? Would participants be as willing to donate after the race? Undoubtedly the organizers of this tissue bank and the Komen Race for the Cure have done an excellent job of advocating for this research, but is there something about breast cancer or about our culture that might (perhaps disproportionately) encourage potential research participants to join the cause?

MCI and Predictive Neuroimaging

Monday ( March 3, 2008) at the weekly PredictER meeting, Andrew Saykin, PsyD, Director, Indiana University Center for Neuroimaging, shared his work on the neuroimaging of Alzheimer's disease. Saykin's study of Alzheimer's began with a small cohort at Dartmouth. Except for the control population, most of participants in this research were diagnosed with MCI (Mild Cognitive Impairment). As his research developed his cohorts began to include individuals reporting memory complaints, but who were not yet diagnosed with MCI. Interestingly, Dr. Saykin has observed changes in the brain scans of both MCI patients and patients with memory complaints compared to his control. Today Saykin is working to build (and collaborate with) larger, more diverse cohorts—cohorts which are easier to find at research institutions, like the Indiana University School of Medicine, located in "sunny" Indianapolis. In addition to representing a more diverse demographic, these developing cohorts will also examine ways to identify, with new imaging technologies and genetic research tools, the earliest biomarkers of the disease. As with many predictive health research studies, the ultimate goal is to identify the disease early enough to develop therapeutic and preventative interventions.

Some of the ethical issues discussed include:

How much to tell research participants: Do participants want to know the results of every memory test and each neuroimaging procedure?

Should researchers be prepared to disclose this information even when a reliable interpretation of the risks is not available?

The value of this research to public health: At the moment and into the foreseeable future, the ability to diagnose the onset of Alzheimer's disease exceeds medicine’s ability to treat the disease … will early diagnostics result in inappropriate marketing of unproven interventions to at-risk individuals?

Will there be a way to protect individuals from wasted expense, discrimination and questionable experimental treatments while at the same time encouraging continued research to understand the disease?

To join us at a future PredictER meeting, check our Center's calendar to verify the time and topic: www.bioethics.iu.edu - calendar

A Public Cord Blood Bank in Indiana? Reviewing House Bill 1020

[In this post contributing author Katherine Drabiak shares her assessment of some of the strengths and weaknesses of Indiana House Bill 1020. The legislation was referred the Committee on Public Health on January 14th, 2008. - J.O.]

Drafters of Indiana’s House Bill 1020 proposing to establish a nonprofit operation of umbilical cord blood bank seem to have learned from the ownership battles over donations recently impeding biobank research efforts. Unlike other existing state laws relating to the property rights associated with cord blood donations, HB 1020 explicitly promulgates a waiver of ownership rights. HB 1020 proposes to illuminate the “ownership” transfer (Chapter 1 Section 7) that would ostensibly be drafted into the informed consent form templates. The current draft of HB 1020 and the proposed amendments as of January 18, 2008 unequivocally specify that any property rights related to the cord blood, including intellectual property rights developed, would vest in the Bank.

While this provision on its face provides additional legal certainty, its efficacy assumes several propositions: the informed consent form is legally sufficient and the pregnant patient truly understands the nature of the donation, the Bank’s IRB will ensure precautions to overcome potential conflicts of interest that could undermine the legitimacy of informed consent, and that property waivers will not be found to conflict with federal law.

As HB 1020 is currently drafted, Chapter 1 Section 4 relating to informed consent broadly tasks the Bank with drafting and providing informed consent forms without specific directives. Prior to donating and signing such a waiver, the pregnant patient must be adequately informed of the options to either donate the umbilical cord blood to the Bank or the possibility of using a private banking facility. Yet currently proposed amendments to HB 1020, if passed, would change the amount of information provided and only inform the pregnant patient of the value of donating to the Bank, eliminating the requirement to discuss the possibility of private banking options. This marks a significant departure from other state law practices, which typically present the pregnant patient with the options of public banking, private banking, or forgoing any donation. This departure could potentially undermine consent by insufficiently informing the pregnant patients. Efforts to promote a public bank may topple, if supported by a weakened informed consent process. Is the fact that few pregnant patients would choose (or be able to afford) a private banking facility a legitimate and prudent reason to eliminate this option in the informed consent process?

The legislation also assumes the sufficiency of potentially blanket consent (Chapter 2 Section 2) and the Bank’s adherence of allocating donations to “ethical” research protocols. The amendments to the legislation propose that the Board of Directors for the Bank would form an independent Institutional Review Board to establish and oversee the informed consent process and privacy protections which would occur separately from the allocation decisions. Per Chapter 1 Section 3, an advisory board comprised of at least 51% research scientists would be tasked with reviewing applications of parties interested in receiving nontransplantable donations. The Board and the IRB are guided by the proposition that research use of the donations shall be used “to promote medical advances, life sciences research, or biotechnology research.” (Chapter 1 Section 5) Logistically, the IRB’s representations of potential research uses of the donations to the pregnant patients should align with the allocation criteria used by the research scientists. If for some reason the majority of the Board decides (assuming research scientists would urge maximum distribution to cutting edge research) to allocate donations to a technologically forward yet ethically questionable project, this may not conform to the IRB’s representations to the pregnant patients during the donation process. The question arises whether the Bank will develop an internal mechanism to ensure the function of the IRB is preserved throughout the allocation process.

Even if the informed consent procedure and forms are found to be sufficient, the property waiver itself could be interpreted as potentially conflicting with federal law. The FDA has objected to the terms donation and abandonment of property rights, asserting that 21 CFR 50.20 prohibits requiring subjects to waive or appear to waive any rights as a condition for participation. Yet recent case law suggests that the drafters of HB 1020 may be on to the recent legal trend that disfavors the FDA’s interpretation and instead posits that the pregnant patient is not actually waiving any legal right by signing the "waiver" because she has no legal right to direct the use of the donation after signing the informed consent form, nor is she entitled to any potential intellectual property rights should they arise. Rather, the property waiver serves as a legal clarification to pre-empt potential disputes from spinning into costly or lengthy judicial interference.

If we assume these potential conflicts relating to the informed consent process and allocation procedure are resolved in an ethical manner, the drafters of the Bill may be initiating a trend to adopt property waivers for all banked donations. If this property waiver is adopted, it would most certainly eliminate many of the potential conflicts previously associated with donating banked specimens and, therefore, would allow the Bank to concentrate fully on maximizing its research efforts. – Katherine Drabiak

Cord Blood Biobanking: Indiana Legislative News

Last week at the Second Regular Session of the 115th Indiana General Assembly, Representatives Peggy Welch (District 60), Eric Koch (District 65), Kreg Battles (District 64), and P. Eric Turner (District 32) introduced House Bill 1020. The proposed legislation will establish a nonprofit corporation to operate an umbilical cord blood bank. As written the legislation also "[r]equires physicians and participating hospitals to inform pregnant patients of the option to donate umbilical cord blood". Although the primary purpose of the bank is to provide medical benefits for Indiana's citizens, it may (depending on the progress of the legislation) provide cord blood for future research studies. The bill was referred the the Committee on Public Health on January 14th, 2008.

PredictER Blog will follow this legislation and will post a more thorough commentary on the ethical, legal and social issues of this proposed biobank in the near future.

Hoosier Eugenics: What would a Christian, Libertarian, Economist Think?

How many Christian-Libertarian-economists are there in the not-so-wide state of Indiana? I'm guessing one: Eric Schansberg, candidate for U.S. Congress, 9th District of Indiana, and the author of SchansBlog. In his recent post, Hoosier Eugenics: A Horrible Centennial, Schansberg weighs in on Indiana's eugenics history and future. Although, given his unique political, religious and intellectual allegiances, most readers will find at least one or two sentences to serve as fodder for scoffing--I did--Schansberg has given more thought to this issue than do most blog authors. In Indiana, a state in which conservative Christian beliefs and attitudes are common, Schansberg is right to recall (in passing) that some of Indiana's religious leaders approved of the state's eugenics programs. Of course, he dismisses these individuals as "liberal Protestants with their Social Gospel", but (to his credit) Schansberg goes on to discuss the controversial "eugenic" opinions of a contemporary, conservative Christian leader--Dr. Albert Mohler, the president of the Southern Baptist Theological Seminary. Schansberg quotes from Mohler's commentary "Is Your Baby Gay? What If You Could Know? What If You Could Do Something About It?" In the eighth of ten points on the subject, Mohler writes: "If a biological basis is found, and if a prenatal test is then developed, and if a successful treatment to reverse the sexual orientation to heterosexual is ever developed, we would support its use as we should unapologetically support the use of any appropriate means to avoid sexual temptation and the inevitable effects of sin." Schansberg seems to disagree with Mohler, as this aside would suggest: "it was left unsaid how Mohler would handle a biological disposition toward alcoholism, pornography or anger. Presumably, the same conclusion applies." He doesn't, however, unequivocally reject Mohler's musings; instead, Schansberg concludes by asking the question: "[W]hen is modern technology a useful way to improve life in an ethical manner?" As a candidate that doesn't seem to worry about alienating the mainstream, it's unlikely that Schansberg is looking for a way to avoid a decisive statement. So, perhaps, he is genuinely asking for more time to think about the issue. Whatever the case may be, he should be commended for discussing the ethical implications for the future and current practice of genetic medicine Indiana.


By the way, if any of PredictER Blog's readers would like to know more about the history of eugenics in Indiana, be sure to investigate the holdings of the Bioethics Digital Library at the Indiana University Center for Bioethics (the home of PredictER). Also see the Indiana Eugenics History & Legacy 1907-2007 Web site (Project Director: William Schneider, Ph.D. Department of History, Medical Humanities-Health Studies Program, Center for Bioethics, IUPUI).

[Photo: "The greatest blessing for a child is to be born of healthy parents"; The Indiana mothers' baby book: a brief treatise for mothers upon pregnancy, preparation for and management of labor, the care of mother and child, and breast and bottle feeding / Indiana State Board of Health. BEDL.]

Remuneration for Healthy Workers: From Sticks to Carrot Sticks?

In July of this year Clarian Health of Indianapolis announced a new health and wellness program for its employees. Employees failing to meet minimum standards for body-mass index (BMI), blood pressure, tobacco use, glucose and cholesterol levels would have been fined $5 per condition per paycheck. Wednesday, NPR's Morning Edition reported that Clarian has revised its health program. The health care institution will not fine "unhealthy" employees, but will offer incentives to encourage healthier lifestyles. This news, also reported in the Indy Star (1 November 2007), will be welcomed by those who are concerned that personal health data, including genetic information, may someday be used in a discriminatory manner in the workplace. If the public strongly objects to requiring a person's BMI and tobacco use to be considered as conditions of employment, it seems even less likely an employer could successfully use a genetic test indicating, for example, an increased risk for breast cancer. Nevertheless, it is still possible, if not likely, that genetic information could be coupled with health-indicators to assess the health risks of individual employees. These individuals might also be encouraged with "incentives" to adopt healthier lifestyles. Before such practices are implemented, employers should think carefully about how employees will interpret these policies. When "unhealthy" individuals are identified with genetic or other bio-information and required to meet certain health goals to receive incentives, are "health incentives" nothing more than repackaged "disincentives"? Could it be that what was once a "stick", is now a "carrot stick"? - J.O.

Health Risk Assessments in the Workplace: Clarian Health, Indianapolis.

At the end of last month Clarian Health of Indianapolis announced a new direction in its wellness and health mission for its 13,000 employees. To enroll for their benefits employees will be required to complete health risk appraisals. Those who fail to meet the employer’s minimum standards for blood pressure, BMI, blood glucose, LDL cholesterol and tobacco use will be fined $5 per condition per paycheck.

Clarian joins many large employers who are attempting to cut health care expenses by offering or requiring health appraisals and incentive-based health promotion measures. As reported by Jessica Marquez in “Being healthy may be its own reward, but a little cash can also help keep works fit” companies (including Delta, Sprint and IBM) are discovering that merely offering a wellness program does not change employee behavior (Workforce Management, September 2005, pp. 66-69 [link requires login]). In fact, as of 2002, Hewitt Associates found that health risk appraisals are increasingly used to refer employees to health intervention programs and 40% of the 960 companies offered financial incentives for participation and/or progress.

Clarian’s announcement drew national attention; negative incentives (docked paychecks) are seldom reported. Coverage in the IndyStar, the La Times and on MSNBC’s TODAY prompted comments from some of the most widely read health and bioethics blogs. Some of these posts, like Kelly Hill’s “Shape Up or Pay Up” (Women’s Bioethics Blog, 30 July 2007), point to the genetic factors in many health conditions and question the fairness of financial disincentives. Hill writes:

[S]hould obesity, high blood pressure, and high cholesterol – things that can be genetic—be looked at with the same light [as smoking]? Should you have to pay $60 a month because your father gave you his high cholesterol?

Arthur Caplan, in “Privacy is the true price of healthy worker discounts” (blog.bioethics.net, 16 August 2007 and MSNBC’s Breaking Bioethics, 15 August 2007), echoes Hills concerns about genetics in the context of personal responsibility:

Who will be next? The guy who skis on the weekends? The woman who wears high heels? What about the family that decides to have a baby, knowing the child may have sickle-cell disease or cystic fibrosis? Will companies be willing to put up with that sort of personal “irresponsibility”?

Caplan’s comment points to an interesting question for the ethics of predictive health. What are the “responsibilities,” personal or social, that accompany a predictive appraisal of one’s health risks? Do individuals with a family history of heart disease have a personal obligation (for the good of the community) to eat well and exercise? If so, who will define and adjudicate these “responsibilities”? Government agencies? Employers? Physicians?