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Posts Tagged ‘PMI Cohort Program

Science Policy Around the Web – April 15, 2016

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By: Daniël P. Melters, Ph.D

Photo credit: Holly Pavlika at Shot@Life.org

Social health policy

Paid maternity leave reduces infant death

In developing nations, more generous maternity leave can save the lives of babies, according to a recent study in PLoS Medicine. The paper estimates that each extra month of maternity leave is linked to about eight fewer infant deaths for each 1,000 live births, or a reduction of 13% in infant mortality. The advantages of paid maternity leave are that mothers-to-be will be able to make use of health services before and after childbirth as their income and jobs are protected. It will also reduce anxiety in mother, improving her health besides that of her baby, the study says. Maternity leave also increase the likelihood that mothers will breastfeed their child and stick to vaccination schedules, potentially increasing the power of paid maternity leave.

Based on our analysis, I’m fairly convinced that increasing the duration of paid leave is an effective way to reducing infant mortality”, the lead author Nandi from McGill University says. He adds that his team controlled for other factors that reduce infant death, such as gross domestic product and national health spending. The researchers compared rates of infant death in two groups of low- and middle-income countries, covering 300,000 life births between 2000 and 2008.

Child health researcher Zulfiqar Bhutta from the University of Toronto is cautious about extrapolating the results from this study over all low- and middle-income countries. “The major limitation here is the assumption that maternity leave policies in a country are universally applied, which they are not.” A cautionary note that Nandi agrees with on the end of implementation, as they did not study this. He also points to research in other areas, which suggest that policies improving the conditions of employees tend to have spillover effects. (PLoS Medicine)

Gene-editing technology

Committee to study oversight of GMOs

The United States is revamping its rules for regulating GMOs, which collectively are known as the Coordinated Framework for Regulation of Biotechnology. To that end, the National Academies of Sciences have convened a committee that is charged with predicted what advances will be made in biotechnology products over the next 5-10 years. It will hold its first meeting on April 18th. To date, GMOs are regulated by three US agencies: US Food and Drug Administration (FDA), US Environmental Protection Agency (EPA), and US Department of Agriculture (USDA). The USDA’s Animal and Plant Health Inspection Service (APHIS) regulates any genetically engineered organisms that may pose a risk to plant health. In addition, GMOs may still undergo a voluntary review at the FDA (as Oxitec did with their GMO mosquito), or face oversight by the EPA.

Recently, the USDA allowed a mushroom that has been genetically modified with the new gene-editing technology CRISPR (removing several base-pairs knocking-out a gene responsible for browning) to allowed on the US market without going through a review process. It is one of about 30 GMOs to sidestep the USDA regulatory system in the past five years. In each case, the USDA deemed that each GMO did not qualify, as something the agency must regulate. In other words, the USDA itself acknowledges that it might be overregulating some crops if they have traits that have already been scrutinized.

This is of course not to say that no oversight is needed. The use of gene editing technology in humans is still controversial, especially in human embryos, as became clear again by a second study published by a Chinese group where they used CRISPR to alter human embryos, or the approval of project in the United Kingdom. New hurdles will be encountered as well. The successful removing of HIV from an HIV infected cell by CRISPR was hailed, but its success was short-lived as HIV found a way to outsmart the power of the current CRISPR technology. The fast moving pace at which gene-editing technology is developing and how its use if being exploited highlights the need for the US regulatory agencies to keep up with these chances both from economical growth as well as a public safety perspective. (Heidi Ledford, Nature)

Precision Medicine Initiative

Dishman to lead PMI Cohort

Dr. Francis Collins, the director of the National Institutes of Health, has announced that the permanent director of the Precision Medicine Initiative (PMI) Cohort Program will be Eric Dishman, taking over the helm from interim director Dr. Josephine Briggs. Dishman, 48, who now heads the Health and Life Sciences Group at Intel Corporation in Santa Clara, California, will start his new job next month. He is not an obvious choice to lead the cohort program as he does not have a background in genomics or large, long-term health studies, nor a PhD or MD degree. He does have a trove of knowledge about health technologies, which will play a key role in the PMI-cohort. At Intel, he oversaw research on devices to help Alzheimer’s patients and elderly living independently. Dishman also battled and overcome a rare type of kidney cancer at the age of 23. Several years ago he has his tumor sequences, which pointed to a treatment that might help save his life. According to Collins, Dishman is the right person to the lead PMI-Cohort program with his “wealth of health innovation experience … as a social scientist and researcher, entrepreneur and business leader, patient and patient advocate, and policy advocate and thought leader.” (Joselyn Kaiser, Science Insider)

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Written by sciencepolicyforall

April 15, 2016 at 1:00 pm

Science Policy Around the Web – February 26, 2016

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By: Kimberly Leblanc, Ph.D.

photo credit: Alex E. Proimos via photo pin cc

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)

FDA Leadership

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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Written by sciencepolicyforall

February 26, 2016 at 9:00 am