The Consortium conducts original research, serves students and faculty, and advances public dialogue and understanding on emerging issues at the intersection of science and society.
Despite the promise of pharmacogenomics – selecting drugs based on a patient's genetic makeup – significant obstacles to its wide implementation remain. According to an article in Scientific American, "fewer than 10 hospitals around the country. . . are offering pharmacogenomic tests," citing two primary impediments to wider use: inadequate insurance reimbursement and the fact that "doctors are not accustomed to making medication choices using genetics." This matters because each year, "half of all medical patients get a drug that could interact with their genes and cause serious side effects." To build understanding and acceptance of the practice, a research group led by Mary Relling, PharmD, of St. Jude Research Hospital in Memphis, has received funding from the National Institutes of Health to document any new drug-gene relations solidified with new research. Pharmacogenomics is the topic of this year's University of Minnesota Precision Medicine Conference on June 20, featuring nationally-known experts in the field; learn more and register here.
Today, the US Food and Drug Administration (FDA) announced it has finalized the new Nutrition Facts label for packaged foods. The changes include a refreshed design that will make it easier for consumers to spot key information such as number of calories and serving size. Reflecting advances in nutrition science, the label will include more information about added sugars, which have been linked to heart disease and currently make up at least 10% of the average American's diet. Serving sizes have been updated to better approximate the portions people actually eat. The new labels have been 2 years in the making, and represent the most significant changes to the label since it was introduced more than 20 years ago. It's hoped the new format will make it easier for consumers to make better, more informed food choices.
An article in the Huffington Post by Robert C. Green, MD, MPH (Harvard, Brigham and Women's Hospital) outlines the conclusions reached by a team of researchers led by Consortium chair Susan M. Wolf, JD; Gloria Petersen, PhD (Mayo) and Barbara Koenig, PhD (UCSF). Their charge: to make recommendations regarding the disclosure of genomic incidental findings to family members of research participants. The national working group for the project included Green and other eminent scholars. Thus far, the study has produced consensus recommendations; a published symposium; and a public conference.
A new proposal by the Obama administration would require scientists who work with human biospecimens to obtain consent from patients prior to using them in research, even when all personal information is removed. The proposed change is part of the revision of the Common Rule, the federal law used to govern research with human participants, which is currently under review. In effect, the new policy would broaden the definition of "human subject" to include tissues, blood, and urine. Some scientists, medical device manufacturers, and advocacy groups are concerned about the chilling effect this could have on research, including the Precision Medicine Initiative. Bioethicists have raised issues about plans to offer new forms of consent, with Consortium collaborator Ellen Wright Clayton, MD, JD, of Vanderbilt University questioning whether those could be effective: “The idea that this informed consent will be in any way meaningful I think is illusory.” Read an article about the debate from STAT here.