By: Kimberly Leblanc, Ph.D.
Precision Medicine Initiative
NIH’s 1-million-volunteer precision medicine study announces first pilot projects
On Thursday, the President participated in a panel discussion at the White House Precision Medicine Initiative (PMI) Summit, marking the one year anniversary of the announcement of the Precision Medicine Initiative, which attempts to tailor medical treatments to individuals. The White House and the National Institutes of Health (NIH) announced several pilot projects, including one to work out how to recruit hundreds of thousands of volunteers online. The cohort program is the largest piece of the PMI: A 1-million-volunteer health study that will probe the interplay among genetics, lifestyle factors, and health. Vanderbilt University Medical Center (VUMC) will lead the Direct Volunteers Pilot Studies under the first grant to be awarded in the federal PMI Cohort Program. The university will work out how to engage participants with a website and a phone line for signing up. Verily, formerly Google Life Sciences (renamed in December 2015), in Mountain View, California, will advise the project. To facilitate the contribution of volunteer data, the NIH is launching a program called Sync for Science, added Francis Collins, M.D., Ph.D., director of the NIH, which will “pilot the use of open, standardized applications that will give individuals the opportunity to contribute their data to research, including for the PMI cohort.” Sync for Science will include participation by electronic health records firms Allscripts, Athenahealth, Cerner, Drchrono, Epic, and McKesson, which have committed to deploying the applications required for individuals to donate their health data directly to the PMI cohort, he said. Such technologies will enable individuals to “control and manage their data … coordinate their care among their healthcare providers, and submit their data to researchers if they choose.” The White House also announced a batch of projects being launched by some 40 universities, patient groups, companies, and others to promote personalized medicine. The PMI “is an all-hands-on-deck operation,” John Holdren, director of the White House Office of Science and Technology Policy, said during the press briefing. “We really need the participation of all of these groups to realize the potential of precision medicine.” (Jocelyn Kaiser, ScienceInsider; a genome web staff reporter, genomeweb)
Public Health and Nutrition
Judge upholds NYC rule on restaurant salt warnings
Justice Eileen Rakower of the New York state Supreme Court ruled to uphold a recent regulation in New York City, requiring restaurants with 15 or more locations nationwide as well as concession stands at some movie theaters and sports stadiums to post a salt-shaker warning symbol next to menu items with more than 2,300 milligrams of sodium. That’s the recommended daily limit proposed in the latest Dietary Guidelines for Americans, released in January. Yet Americans are consuming close to 3,440 milligrams a day on average. Most of the sodium we consume is already added to our food, whether its in the processed foods we buy in the grocery or the meals we’re served in restaurants. Mandated salt warnings on menus are intended to make New Yorkers more aware of the link between excessive salt in their diets and high blood pressure, heart disease and stroke, according to health officials.
“I believe that the New York City salt label [on menus] does protect public health,” said Thomas Merrill of the Department of Health & Mental Hygiene. He says it gives people the information they need to make informed choices. New York City adopted the rule in December, and the National Restaurant Association then sued the city’s Board of Health saying the rule unfairly burdened restaurant owners. In court on Wednesday, Rakower denied the restaurant group’s motion for a preliminary injunction to stop enforcement of the rule. Starting March 1, violators will be punished by $200 fines. Unlike the city’s unsuccessful large-soda ban, she said, the rule did not restrict the use of sodium. S. Preston Ricardo, a lawyer for the restaurant group, said the association intended to appeal. Overall, health officials are happy with the judges’ decision. “This is really good news for the health of New Yorkers,” said Dr. Mary Travis Bassett, the city’s health commissioner. (Karen Freifeld with additional reporting by Jonathan Stempel, Reuters; Allison Aubrey, NPR)
Robert Califf confirmed as new FDA head
On Wednesday, after 4 months of delay, the U.S. Senate approved cardiologist Robert Califf, President Obama’s pick to head the Food and Drug Administration (FDA) by a vote of 89 to four. The nomination, announced last September, has faced significant opposition. Senators Edward Markey (D–MA) and Joe Manchin (D–WV) have both used the nomination as a chance to express frustration with the FDA over its response to the epidemic of opioid abuse—to argue that the agency has been too permissive in its approval of prescription opioids, and has failed to consult its scientific advisory board in those decisions. Ill will toward the agency over its approval of genetically modified salmon last November led Senator Lisa Murkoswki (R–AK) to block the nomination and demand that FDA put out guidelines requiring the fish to be labeled (Murkowski later lifted her hold.) And Senator Bernie Sanders (D–VT) also blocked the nomination, citing concerns that Califf wouldn’t be motivated to help combat the rising cost of prescription drugs. There were also personal concerns about Califf and his long-standing ties to the pharmaceutical industry — which funded many clinical trials he oversaw as an academic — and questioned whether his interests lay more with drug companies than with ordinary patients. In a confirmation hearing last fall, Califf defended his past work and said he had no intentions of lowering the FDA’s standards for safety and effectiveness of drugs and devices. After winning confirmation Wednesday, he spoke in a brief interview with the Washington Post about his priorities as FDA commissioner, including a desire to better explain to the public how the agency operates. (Kelly Servik, Science Insider; Brady Dennis, Washington Post)
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