1.7-million Americans will pick up infections at the hospital this year, often antibiotic resistant superbugs hard to disinfect, that can potentially be fatal.
That has apparently happened to an eight-year-old Westlake boy. During the time he was receiving chemotherapy for his brain cancer, he got C. diff. , a superbug that kills one in ten people who get it, and lingers on surfaces for months. But Aydan Chapman is safely home now, his entire house disinfected by a superbug zapping robot.
The San Antonio based company Xenex recently sold its disinfecting robots to St. Davids in Austin. Within minutes, they can disinfect a hospital room for anything from Ebola, C. diff. MRSA, norovirus, even Anthrax.
Also this fall, Aydan Chapman learned that he had acquired c-Diff, around the time of his chemo treatment at Dell Children’s Medical Center. Dell confirmed the infection. Aydan had already endured four brain tumors since 2009, now he is enduring chemo and strong antibiotics for the superbug.
Bryce Chapman, Aydan’s father, is hearing impaired but told KXAN through a Community Service for the Deaf sign reader, “It was extremely frustrating to see what was happening with him. It was actually two to three weeks before we learned he had the c-Diff, so he had gone through so much at this point. It felt like he was getting hit by more than one thing.”
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National Action Plan for Combating Antibiotic-Resistant Bacteria.
The Obama administration has issued a detailed plan to address the problem of antibiotic resistance, complete with milestones to help ensure the goals are actively addressed.
Drug-resistant bacteria cause 23,000 deaths and two million illnesses a year in the United States, according to the Centers for Disease Control and Prevention. Resistance also threatens animal health and agriculture, said the White House.
The 63-page National Action Plan for Combating Antibiotic-Resistant Bacteria, released March 27, 2015 was developed by a task force made up of representatives from at least a dozen federal agencies. The task force began meeting in September 2014, taking its cues from an executive order issued by President Obama on September 18, 2014, and from recommendations in a report on antibiotic resistance that was issued by the President’s Council of Advisers on Science and Technology around the same time.
The action plan aims “to enhance domestic and international capacity to prevent and contain outbreaks of antibiotic-resistant infections; maintain the efficacy of current and new antibiotics; and develop and deploy next-generation, diagnostics, antibiotics, vaccines, and other therapeutics,” according to the White House.
The plan sets 1-, 3-, and 5-year targets in each of the five overarching goals, which are to:
slow the emergence of resistant bacteria and prevent the spread of resistant infections;
strengthen national one-health surveillance efforts to combat resistance (the “one-health” approach to disease surveillance integrates data from multiple monitoring networks, according to the White House);
advance development and use of rapid and innovative diagnostic tests for the identification and characterization of resistant bacteria;
accelerate basic and applied research and development for new antibiotics, other therapeutics, and vaccines; and
improve international collaboration and capacities for antibiotic resistance prevention, surveillance, control, and antibiotic research and development.
Having specific benchmarks is something that the Infectious Diseases Society of America (IDSA) has advocated, said Amanda Jezek, vice president of public policy and government relations at IDSA. “That helps ensure that this isn’t just an action plan that will sit on the shelf and collect dust,” Jezek told Medscape Medical News.
Hospitals will be required to implement programs to increase infection controls, such as judiciously washing hands, hospital surfaces and equipment, and reducing the use of antibiotics in patients.
Doctors working with the government’s Medicare and Medicaid health plans will be required to report their prescribing patterns for antibiotics, particularly when used to treat non-bacterial infections, such as common colds.
The plan calls for CDC to increase its screening of people arriving from countries with high rates of multi-drug resistant tuberculosis. The CDC currently screens 500,000 such arrivals per year, and the plan calls for doubling that within five years.
Urgent and Serious
Among other targets, the plan sets goals for eradicating pathogens that have been labeled urgent or serious threats by the Centers for Disease Control and Prevention. The 2020 targets include:
a 50% reduction from 2011 estimates in the incidence of Clostridium difficile,
a 60% reduction in hospital-acquired Carbapenem-resistant Enterobacteriaceae infections,
a 35% reduction in hospital-acquired multidrug-resistant Pseudomonas species infections, and
a 50% reduction from 2011 estimates in methicillin-resistant Staphylococcus aureus bloodstream infections.
Also by 2020, the action plan seeks a 50% reduction in inappropriate antibiotic use in outpatient settings and a 20% reduction in inpatient settings, as well as routine reporting of antibiotic use and resistance data to Centers for Disease Control and Prevention’s National Healthcare Safety Network by 95% of Medicare-eligible hospitals.
The plan also envisions by 2020 the development and wide dissemination of rapid diagnostic tests that can be used in a physician’s office or at the hospital bedside to distinguish between viral and bacterial infections, and thus help ensure more appropriate use of therapeutics.
Under research and development, the plan calls for the characterization of the gut microbiome of at least one animal species raised for food to potentially treat bacterial diseases without antibiotics, and at least three new probiotic therapies for animals by 2020.
In the same time frame, the plan dictates the development of at least two new drug candidates or nontraditional therapeutics and/or vaccines for the prevention of human disease.
The action plan also outlines proposals to work with other governments around the world to enhance the capacity to identify resistant pathogens and to help low- and middle-income countries develop stewardship plans.
$1 Billion to Start?
The White House said the plan’s aspirations are “consistent” with the president’s fiscal 2016 budget proposal, which seeks more than $1 billion to combat antibiotic resistance.
Jezek, from the IDSA, said the $1 billion is a good start and notes that there is bipartisan support for battling antibiotic resistance. “To me, the big question is, Can we get Congress to actually allocate all of that money?” she said.
The automatic budget cuts known as sequestration loom large over any request for funds that are not for mandatory programs, which could make it hard to get the full 2016 request from lawmakers, said Jezek.
The IDSA is also calling on the federal government to ensure the establishment of antibiotic stewardship programs in all healthcare facilities and to pass incentives to encourage drug, diagnostic, and vaccine development.
The federal interagency task force is scheduled to provide a progress report on the action plan within 6 months of its release — by September. It will then make annual progress reports and make recommendations to modify goals if necessary.
The task force is also supposed to work in conjunction with the Presidential Advisory Council on Combating Antibiotic Resistance, a 30-member board that has yet to be constituted.
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President Obama today will announce the launch of a $215 million precision medicine initiative to leverage advances in genomics, informatics, and health information technology to accelerate biomedical discoveries in the hopes of yielding more personalized medical treatments for patients in the US.
The public-private initiative, which will be included in the President’s 2016 budget proposal to be released next week, will provide new funding to the National Institutes of Health, the National Cancer Institute, the US Food and Drug Administration, and the Office of the National Coordinator for Health Information.
That funding will help those agencies to, among other things, develop a voluntary national research cohort of more than 1 million people, obtain sequencing data for as many of those individuals as possible, identify genomic drivers of cancer, improve how next-generation sequencing-based tests are evaluated and marketed, and develop methods for managing and analyzing large patient data sets while protecting individual privacy.
“Precision medicine is about moving beyond this one-size-fits-all kind of approach to medicine and instead approaching disease prevention and treatment by taking into account individual differences in people’s genes, their microbiomes, their environments, and their lifestyles,” Jo Handelsman, associate director for science at the White House Office of Science and Technology Policy, said yesterday in a press briefing previewing today’s announcement. “The idea is to give clinicians tools to better understand the mechanisms underlying a patient’s condition, and to better predict which treatments will be most effective and safe.”
The largest part of the initiative will provide $130 million to the NIH to help develop a national research cohort of a million or more volunteers whose data — including medical records, genetic and metabolomic profiles, microbiomes, and environmental and lifestyle information — will contribute to a further understanding of disease and help establish a new way of doing research through engaged participants and open, responsible data sharing, the White House said.
In addition, the NCI will be budgeted for $70 million to scale up efforts to understand the genetic basis of cancer by expanding genetically based clinical trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network” that will generate and share new knowledge.
Meantime, $10 million will be earmarked for the FDA to help it acquire additional tools and expertise to develop high-quality, curated databases that will be used in its efforts to evaluate next-generation sequencing technologies and ensure their accuracy, reliability, and safety for patients.
And, finally, the initiative calls for a $5 million investment in the ONC to support the development of interoperability standards and requirements that address patient privacy and enable the secure exchange of data across systems.
“This concept of precision medicine – that is, prevention and treatment strategies that take individual differences into account – is not entirely new,” NIH Director Francis Collins said during the briefing. “But for much of medicine, this kind of personalizing just has not been possible. We just didn’t know enough. That’s all changing now, and at an unprecedented pace, which makes now the right time to launch this initiative.”
Collins pointed to advances over the past several years in basic research, data science, mobile connectivity, use of electronic medical records, and “perhaps most dramatic of all in terms of the scale, the decline in the cost of DNA sequencing. It cost us $400 million for that first genome, and now a genome can be sequenced for a cost approximating $1,000. That’s more than 100,000-fold drop in 15 years.”
Regarding the NIH’s plan to create a longitudinal cohort of more than 1 million patients, Collins noted that the agency and its partners will not need to start from scratch, but will instead tap into already-established cohorts, both public and private.
“We are aware that there is something like 200 cohorts that have already been put in place that have at least 10,000 participants,” Collins said. “They’re in different sorts of shape as far as the kind of information that’s already been collected. But there is a wealth of potential there.”
Collins noted that a large part of this cohort effort will be trying to piece together many of these existing cohorts, and he said that this could be aided by existing projects such as the Electronic Medical Records and Genomics (eMERGE) program, which aims to combine electronic medical records technologies with DNA biorepositories for use in large-scale, high-throughput genomics research projects.
In terms of the types of existing cohorts that could be tapped into, Collins mentioned the attractiveness of the cohorts generated so far under Kaiser Permanente’s Research Program on Genes, Environment, and Health, which includes more than 430,000 adult members of Kaiser’s system in Northern California and has generated a 100,000-individual cohort in partnership with the University of California, San Francisco. However, Collins stressed that the NIH will be encouraging new participants to volunteer to help build the national cohort.
Another large part of the cohort effort will be attempting to obtain sequencing data for as many of the participants as possible. Although the cost of sequencing has dropped dramatically in recent years, this component of the initiative remains a major hurdle.
“We would love to have whole-genome sequence [data] on all the participants in the cohort, but the expense has to be considered, and where are we going to find those funds?” Collins said. Although it now costs about $1,000 to sequence a whole genome, “that curve is coming down, and that is actually quite reassuring,” Collins added. “It will take us, of course, a matter of some time to assemble this cohort. Our expectation would be that, as it’s being assembled, the cost [of sequencing] would be coming down, and so ultimately the goal would be to have a full-genome sequence on as many of the cohort as are comfortable.”
Another important aspect of the national cohort project will be its interactive nature. “The precision medicine initiative is not just about scale,” Collins said. “It’s also intended to be a new model of research, one in which people who participate are true partners – not subjects, not even patients – partners.”
To that end, the ONC is charged with developing new and better ways to ensure secure data exchange with patients’ consent, and the initiative overall will be committed to protecting patients’ privacy by launching a “multi-stakeholder process” that will solicit input from patient groups, bioethicists, privacy and civil liberties advocates, technologists, and other experts to identify legal and technical issues.
Summarizing, Collins noted that although the cohort initiative will likely yield its greatest benefits many years into the future, “there should be some successes in the relatively near future, as well, especially in the areas of cancer, and the field called pharmacogenomics – how to provide the right drug at the right dose to the right patient at the right time. This initiative will provide a wonderful platform for finding out how to apply that strategy to more and more people.”
On the regulatory side, FDA Commissioner Margaret Hamburg noted during the briefing that the agency’s funding would primarily be used to improve the way it oversees the marketing of new types of precision medicine technologies, particularly NGS.
“Our current market review approaches for evaluating a test’s analytical and clinical performance are designed around a more traditional one test-one disease paradigm,” Hamburg said. “In contrast, next-generation sequencing produces a massive amount of data, potentially bearing on a huge range of diseases, conditions, and risk factors that will be better handled using a new approach.”……………………………………….
…………. the FDA is currently in the process of considering what that approach should be, referring to the fact that the agency has scheduled a public meeting on Feb. 20 to discuss the challenges of regulating NGS technologies. Ahead of the meeting, last year the agency issued a white paper to lay out its current thinking and provide the basis for future discussion.
President Obama plans to fully announce the precision medicine initiative at an 11:00 AM event at the White House today.
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