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New Obama Medical Project - Genetics, not HCV
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from Jules: I guess the fact that we have a cure for HCV, a leading cause of death in the US and globally, is not enough for The White House to dedicate similar funding to care & screening, instead a grant of $55 million goes from Obama to future research into Precision Medicine & genetics and of course his decision to appoint Biden a cancer leader, although hopeful we actually have a cure for HCV, which in fact is a tremendous burden not only to infected individuals but to the cost structure for the entire healthcare system - no this is not enough, The White House continues to essentially ignore HCV, that is, there is hardly any funding for HCV - $35 mill to CDC, but $10 billion each year just for HIV medicaid & medicare, and untold additional tens of billions of dollars for HIV for privation, research, cure etc, which it deserves & should get. I have been working on & covering & reporting on & doing advocacy & policy work in HCV since 1998. I was at the first HCV workshop in 1998 where only 10 researchers attended and Vertex presented the first protease inhibitor, no it as not telaprevir - it was a forerunner drug- and the consensus in the field back then was we would not be able to develop a protease inhibitor for HCV because the pocket in which it needed to bind was too shallow so its unlikely we would be able to move this ahead. 20 years and 10s of billions of dollars in research later, we have a cure, the first time in medical history we can cure a virus, with only 12 weeks of tolerable & safe treatment, a medical miracle, a milestone in medicine. YET The White House refuses to provide funding to "eliminate HCV". If there was such a cure for cancer do you think The White House would not make sure treatments were made available for all. The stigma of HCV is a killer & drives White House & Congressional policy.
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Obama Seeks To Make Mark On Genetic Medicine
Jul 6, 2016
http://www.forbes.com/sites/matthewherper/2016/07/06/obama-seeks-to-make-mark-on-genetic-medicine/#4ce5696e2b0d
President Barack Obama seems intent on making his long-term mark on medicine. After a few weeks of hype around his administration's efforts to speed cancer research, officials tonight announced plans to kickstart efforts around his Precision Medicine Initiative.
The National Institutes of Health will spend $55 million in a single year to begin a study of a million American volunteers who will consent to have their bodies measured in myriad ways to figure out how genetic and environmental risk factors interact to cause disease. On a conference call this evening, NIH Director Francis Collins said the project "has the potential to truly transform the practice of medicine" and predicted that understanding individual differences will allow doctors to better prevent and treat illness. In an unprecedented effort, it will try to return all the data that is collected to the study participants. Meanwhile, the Food and Drug Administration is releasing two draft guidance documents that could smooth the regulatory path of tests that make use of DNA sequencing to diagnose disease. Update: The FDA draft guidances can be found here and here.
The NIH aims to recruit its first patients later this year, and announced four centers that will lead the way in recruiting patients: Columbia University Medical Center in New York, Northwestern University School of Medicine in Chicago, the University of Arizona and the University of Pittsburgh. Each will receive an initial grant of $4 million.* The U.S. Department of Veterans Affairs will get its own $4 million initial grant.
Data analytics for the project will be handled by a team at Vanderbilt University in Nashville, Tenn.; Verily, the life science arm of Alphabet (formerly Google); and the Broad Institute in Cambridge, Mass. They will receive a combined first-year grant of $14 million.
The biggest grant, of $20 million, will go to the Scripps Research Institute in La Jolla, Calif., which will be charged with creating mobile and web applications to collect data from individuals, and to return that data to patients. It will work with Sage BioNetworks, a data advocacy group; PatientsLikeMe, which specializes in self-reported patient data; and Walgreens, the pharmacy arm of Walgreens Boots Alliance . "I've never seen the NIH move like this in my years as a researcher," says Eric Topol, Director of the Scripps Translational Science Institute. "It's been phenomenal to see."
The FDA guidance documents, which were not available for review, will aim to speed the approval of DNA sequencing machines. Given the huge number of potential tests (there are more than 20,000 genes in the human genome), there have been questions about how the FDA would regulate such machines. Liz Mansfield, the director of personalized medicine at the FDA's Center for Devices and Radiological Health, says the documents set up to related paths.
The FDA wouldn't require every new test to prove it gives accurate results through a time-consuming process, but would instead employ standards that would show the machines worked as they are supposed to. In a second guidance document, the FDA builds on the way it has approved some genetic tests already: It would allow documentation in any of several verified databases to be used to demonstrate that a test is useful to patients. It did something similar when it approved DNA sequencing tests from the Illumina, the maker of DNA sequencers, for cystic fibrosis, and a cancer test from Myriad Genetics that is paired with new drugs for ovarian cancer.
Importantly, Mansfield notes, the new documents don't apply to tests used for cancer, but for hereditary conditions. Many tests will still not be regulated by FDA, as the agency uses enforcement discretion for tests that are created and used by a single laboratory. The documents, which will be available online later tonight, should be a first step in a more streamlined process for DNA sequencing machines.
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