PredictER News Brief - Published Today

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.

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.

Personalized Therapeutics at IU

In August 2008, the Indiana University Department of Medicine’s Division of Clinical Pharmacology began a new series of compelling seminars that may be of great interest to those involved in predictive health research ethics. The Personalized Therapeutics Seminar series commenced on August 5th with a presentation on the FDA’s Sentinel System for Post-market Drug Safety Surveillance given by Barbara Evans, J.D., Ph.D. from the Health Law and Policy Institute at the University of Houston Law Center. Additional speakers this fall, all from the Indiana University School of Medicine, have included Dr. Noah Hahn presenting on the Indiana University Cancer Biomarker Study, Dr. David Haas addressing PREGMED and the search for individualized pharmacotherapy in pregnancy, Dr. Zeruesenay speaking about emerging in vivo phenotyping methods and Dr. Tatiana Foroud addressing the results of whole genome association studies and how they may change our approach to medicine. The next seminar, entitled Personalized Therapeutics in Breast Cancer: A Model for Translating Pharmacogenomics, will be presented Dr. David Flockhart, Chief of the Division of Clinical Pharmacology, on September 9th. All seminars in this series are held on Tuesdays from 12:00pm – 1:00pm, in room W7120 on the 7th floor of the Wishard Myers Building.

For a complete schedule, please see: http://medicine.iupui.edu/clinpharm/PMG/PT_Seminars.asp [link edited 9-18-09]



Amy Lewis Gilbert

Medical Records, Insurance and Prediction: GINA Will Not Keep this Fox Out of the Henhouse

In a recent Washington Post article (4 August 2008), "Prescription Data Used to Access Consumers", Ellen Nakashima writes about the availability of medical records for data mining. Insurance companies have begun to use databases of prescription records to assess the risks of insuring individuals or when deciding to pay for a treatment. For example, a report could show that an "individual has been on the highest does of the cholesterol-reducing drug Zocor for 18 months" and an insurance company could determine that the patient has "a very high, near-intractable cholesterol problem … and could avoid a costly blood test". The article also points out that these records are more honest than many applicants for insurance and could reduce the cost of insurance while facilitating faster decision making. While HIPAA stipulates that patient consent must be acquired before these records can be accessed, "HIPAA does not give the Department of Health and Human Services the ability to directly investigate or hold accountable … pharmacy benefit managers". Nakashima reports that the increasing availability of electronic records will result in a market in which data mining organizations compete to sell the most complete and cheapest sources of patient data to insurers. Joy Pritts, of the Georgetown University Health Policy Institute observes that "Most people don't even know these organizations exist . . . ." Privacy consultant, Bob Gellman notes that "consumers will likely continue to have no real meaningful choices if they want insurance". Richard Dick, a database designer, suggests better privacy tools for consumers which would allow patients to be more specific when consenting to release medical information, "Otherwise … you have the fox in charge of the henhouse".

I want to know what incentives motivate patients to consent to release this information in the first place. I'm guessing that insurance coverage may depend upon consent; if so, is this real "consent"? – J.O.

PredictER Year-End Review

Join us Monday afternoon (August 4th, 3-4pm) at the Center for Bioethics for a year-end review of PredictER's progress. PredictER's director, Eric M. Meslin, will share his assessment of the program's accomplishments and goals for the coming year. This is an excellent opportunity to learn about the services we provide to our constituents with an interest in predictive health research, medicine, and the associated ethical and legal issues. Refreshments will be served.

IU Center for Bioethics, 410 W 10th Street, Suite 3100. Indianapolis, IN 46202 | 317-278-4034

What's in Steve Jobs's Genome? Genetic Information at the Top

Jacob Goldstein of The Wall Street Journal's Health Blog asks "Do Apple Investors Have Right to Steve Jobs's Health Info?" -- Investing is a gamble and gamblers need good information to make the best bets. Publicly traded companies are required (with varied levels of success) by the SEC to be transparent with their books. So, if you're thinking about investing in a company with a very charismatic CEO, you might want to know about the results of his most recent physical exam. As genomic medicine improves one could imagine a future in which "reasonable" investors demand a genome profile too. Goldstein observes that Jobs is both a "swashbuckling entrepreneur" and a pancreatic cancer survivor. I'm unsure how that information would help an investor and I'm fairly certain the science of reading the genomic tea leaves would not be much help, at least not yet.

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.