Health and Human Services Secretary Sylvia M. Burwell today announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to facilitate the development and availability of experimental Ebola vaccines.
This declaration is intended to assist in the global community’s effort to help combat the current epidemic in West Africa and help prevent future outbreaks there, the HHS said.
The declaration provides immunity under United States law against legal claims related to the manufacturing, testing, development, distribution, and administration of three vaccines for Ebola virus disease. It does not, generally, provide immunity for a claim brought in a court outside the United States.
Past declarations have covered vaccines used in H5N1 pandemic influenza clinical trials in 2008, products related to the H1N1 influenza pandemic in 2009, and the development and manufacturing of antitoxins to treat botulism in 2008.
Here are more details about the action from the HHS release:
Microsoft co-founder and philanthropist, Paul G. Allen will donate $100 million to create the Allen Institute for Cell Science in Seattle.
The Institute will be dedicated to the study of the complex living machinery of cells. The initial focus will be on how information encoded in our genes becomes three-dimensional living cells, and what goes wrong in disease?
The inaugural project, called the Allen Cell Observatory, will produce a dynamic, visual database and animated models of cell parts in action that integrate information from across the cellular and molecular sciences. The institute will make all its data, models and tools publicly available online
The Allen Institute for Cell Science will be housed in the new Allen Institute building located in Seattle’s South Lake Union neighborhood. The seven-story, 270,000 square foot building, currently under construction, will also be occupied by the Allen Institute for Brain Science. The building is scheduled for completion in the fall of 2015.
Rick Horwitz will serve as the Executive Director of the Allen Institute for Cell Science. He served for 10 years as the Director of the Cell Migration Consortium, an NIH-funded multi-institutional, multi-disciplinary collaboration for studying cell migration, and spent the past 15 years in the Department of Cell Biology, as a Harrison Distinguished Professor and University Professor, at the University of Virginia, School of Medicine, where his lab investigated the mechanisms of cell migration and dendritic spine morphogenesis.
A community conversation sponsored by the Northwest Biomedical Research Association
Are Vaccinations ‘Everybody’s Business?’
Discussion of the locally-made documentary, “Everybody’s Business,” by Laura Green, which examines the small, tight-knit community of Vashon Island that has become a reluctant poster child for the growing debate around childhood vaccinations. This portrait of an island community digs beneath the surface to investigate the tensions between individual choices and collective responsibilities.
Tuesday night’s conversation will be facilitated by Dr. Doug Opel, Seattle Children’s Research Institute.
December 9, 2014
From 5:45pm to 7:45pm
415 Westlake Ave N.
Seattle, WA 98109
There are many options available allowing patients with diabetes to monitor and manage their glucose levels. The continuous glucose monitor (CGM) shown here includes a glucose level sensor and transmitter, a data receiver which displays the patient’s glucose levels, and an insulin delivery system.
FDA Consumer Update
Do you have diabetes? Do you notice that your blood glucose (sugar) levels rise or fall quickly? Has your doctor prescribed insulin to treat your diabetes? Are you comfortable with using a medical device?
If you answered yes to all of those questions, continuous glucose monitors (CGMs) and insulin pumps are tools that you and your health care professional might consider to assist you in achieving stable blood sugar levels.
People with health coverage – including those who buy it through government insurance exchanges and Medicare beneficiaries – are likely to pay more out-of-pocket next year for so-called “specialty drugs,” which treat complex conditions, according to two studies from consulting firm Avalere Health.
More than half of the “bronze” plans now being sold to individuals through federal and state marketplaces for coverage that begins in January, for example, require payments of 30 percent or more of the cost of such drugs, Avalere said in a report out Tuesday. That’s up from 38 percent of bronze plans this year.
“…in some cases this could make it difficult for patients to afford and stay on medications,”
In “silver” level plans, the most commonly purchased exchange plans, 41 percent will require payments of 30 percent or more for specialty drugs, up from 27 percent in 2014.
As the cost of prescription medications rise, insurers are responding by requiring patients to pay a percentage of specialty drug costs, rather than a flat dollar amount, which is often far less. Insurers say the move helps slow premium increases. Continue reading →
This month, PATH produced a new tool for diagnosing river blindness, a disease that affects nearly 18 million globally (stats that are often unheard of). It’s the first of its kind, says Nicole Fallat, Communications Officer at PATH.
Earlier this month, Arizona voters approved a referendum that allows terminally ill patients to receive experimental drugs and devices. It’s the fifth state to approve a “right-to-try” law this year.
Supporters say the laws give dying patients faster access to potentially life-saving therapies than the Food and Drug Administration’s existing “expanded-access” program, often referred to as “compassionate use.”
Supporters say the laws give dying patients faster access to potentially life-saving therapies. Critics charge such ‘right-to-try” acts are feel-good laws that don’t address some of the real reasons patients may not receive experimental treatments.
But critics charge they’re feel-good laws that don’t address some of the real reasons patients may not receive experimental treatments.
The legislatures in Colorado, Louisiana, Michigan and Missouri also passed right-to-try laws this year as part of a nationwide effort spearheaded by the conservative Goldwater Institute, which hopes to get right-to-try laws on the books in all 50 states.
The measures generally permit a patient to get access to an experimental drug after it’s passed through phase 1 of a clinical trial, the initial testing in which a drug is given to a small group of people to evaluate its safety and side effects.Continue reading →
IN THE battle against Ebola, mobile phones could be invaluable—not just in themselves, as devices that can be used to send people public-health information or let them call helplines, but also because of the data they generate.
The United States Centers for Disease Control commissioned The Nebraska Medical Center biocontainment unit in 2005.
It was designed to provide the first line of treatment for people affected by bio terrorism or extremely infectious naturally occurring diseases. It’s the only non-governmental facility of its kind in the U.S.
The staff, all receive specialized training and participate in drills throughout the year. In a recent drill, the staff practiced dressing in spacesuit-like personal protection suits.
The suits provide each staff member the ability to care for an infected patient without exposing themselves. They also practice transporting an infected patient in a “bio pod” into a specially designed room inside the biocontainment unit.
The entire unit is specially isolated from the rest of the hospital, using its own ventilation system and security access.
Proton therapy has been touted as the next big thing in cancer care. The massive machines, housed in facilities the size of football fields, have been sprouting up across the country for a decade.
There are already 14 proton therapy centers in the U.S., and another dozen facilities are under construction even though each can cost $200 million to build.
But Indiana University shocked experts who watch the industry last month when it announced that it plans to close down its facility in Bloomington, as reported by Modern Healthcare.
“I never thought that in my lifetime I would see a proton center close,” says Amitabh Chandra, a professor at Harvard’s Kennedy School of Government who studies the cost of American medical care.
He’s surprised because until now, industry growth has been entirely in the other direction, even though there’s little evidence that proton therapy is better than standard radiation for all but a few very rare cancers.
“But we do know it is substantially more expensive and substantially more lucrative for physicians and providers to use this technology,” Chandra says.
In the Washington, D.C., area alone, three proton therapy centers are under construction — one at Johns Hopkins Medicine Sibley Memorial Hospital, another at MedStar Georgetown University Hospital, and a third, the Maryland Proton Treatment Center, is slated to open at the University of Maryland in Baltimore next year.
All three say they are continuing to build their centers, despite the news out of Bloomington. In email statements, two said that the larger population of the DC-Baltimore area can support a proton facility better than a small city like Bloomington. The third said it’s building a smaller, one room center that will be more cost effective.
Dr. Minesh Mehta, medical director of the Maryland Proton Therapy Center stands with Dr. William F. Regine, radiation oncologist at the University of Maryland and James DeFilippi, vice president of project development at the construction site of the Maryland Proton Treatment Center in this May 2013 photo (Photo by Jenny Gold/KHN).
But in Indiana, a review committee determined that it just wasn’t worth spending the money that would be necessary to update their proton facility.
Cigna, for example, only covers proton therapy for a single rare eye cancer, says Dr. David Finley, the insurer’s national medical officer.
“When it’s used, however, for all other tumors, it’s not been shown to be any more effective than other forms of radiation therapy,” says Finley.
Proton beam therapy costs three to six times as much as standard radiation therapy for illnesses like prostate cancer, according to Finley. He adds that when insurers pay for expensive care that isn’t any better than the cheaper options, it can increase the cost of everyone’s health care.
“We said if two services offer the same result and one is much more expensive than the other one, we’re only going to pay for the one that is less expensive,” Finley says.
Other major insurers have also limited what they’ll cover with proton therapy, including Aetna and Blue Shield of California.
One health care payer that has not put any restrictions on proton therapy is Medicare. And Medicare pays much more for the treatment than it pays for standard radiation therapy.
“That’s the problem with Medicare payment policy,” says Harvard’s Chandra, “it not only covers treatments that are dubious treatments, it also covers dubious treatments extremely generously.”
But the doctors and researchers involved with building new proton beam facilities don’t think the treatment is dubious. They point to proton therapy’s potential to kill cancer without damaging surrounding tissue, and they say that it’s just a matter of time before clinical trials prove that proton therapy is worth the extra money.
Kaiser Health News is an editorially independent program of the Henry J. Kaiser Family Foundation, a nonprofit, nonpartisan health policy research and communication organization not affiliated with Kaiser Permanente.
Everyone seems to agree that proton beam therapy–a type of radiation that can attack cancerous tumors while generally sparing the surrounding tissue–is an exciting technology with a lot of potential.
But some insurers and disease experts say that, until there’s better evidence that proton therapy is more effective at treating various cancers than traditional types of less expensive radiation, coverage shouldn’t be routine.
That approach doesn’t sit well with proponents, some of whom say that insurance coverage is critical for necessary research of the controversial therapy’s uses.
Critics assert that the rush to build the centers is putting a very large cart before the horse.
Meanwhile, the number of proton therapy centers — huge structures that can cost more than $200 million — continues to increase.
Actress’ impact on genetic testing for breast, ovarian cancer is ‘global and long lasting’
Angelina Jolie – Photo courtesy of the UK Foreign and Commonwealth Office
By Mary Engel / Fred Hutch News Service
Sept. 18, 2014
The so-called Angelina Jolie effect not only is real but has been “global and long lasting,” leading to a twofold increase in the number of women getting genetic testing to help determine their risk for hereditary breast cancer, according to new studies from the United Kingdom and Canada.
The number of women found to have a genetic mutation that increased their risk also has doubled.
And contrary to concerns that women at low risk for hereditary breast cancer would flood testing centers, researchers said that those being tested are women like Jolie who have a family history of breast cancer or who have personal risk factors such as ethnicity.
Certain ethnic groups, including Ashkenazi Jews, have a higher prevalence of BCRA mutations, which significantly increase breast cancer risk.
Women got the correct message
“What surprised us was that we didn’t get the worried well,” said Dr. Andrea Eisen, head of preventive oncology for breast cancer care at the Sunnybrook Odette Cancer Centre in Toronto and an author of the Canadian study, in a phone interview. “We got women who got the correct message. That was gratifying.”
Jolie disclosed in a May 2013 op-ed in The New York Times that she had undergone a preventive double mastectomy after finding that she carries the rare BRCA1 gene mutation, which dramatically raises her risk of breast and ovarian cancers.Continue reading →
King County has received a four-year, $6 million grant to improve testing, treatment and cure rates of people with chronic HCV infection.
Hepatitis C virus (HCV) affects large numbers of people in King County, but it often goes unnoticed until it’s too late.
“Thousands of people in King County have chronic HCV, but many don’t know they have it,” said Dr. Jeff Duchin, Chief of Communicable Disease & Epidemiology at Public Health – Seattle & King County. “This grant will allow us to make sure that patients with chronic HCV are not just identified, but also seen by a provider, receive follow-up testing, and get the care they need.”
The grant will fund the Hepatitis C Test & Cure Project, which will provide training for clinicians on the diagnosis, evaluation, and treatment of HCV and connect them to specialists. Continue reading →
Infertility treatment is a numbers game in some respects: How many treatments will it take to conceive a child? And how much can you afford?
Even as insurance plans are modestly improving their coverage of such treatments, clinics and others are coming up with creative ways to cover the costs to help would-be parents reduce their risk for procedures that can run tens of thousands of dollars.
Initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The early-stage trial will begin initial human testing of a vaccine co-developed by NIAID and GlaxoSmithKline (GSK) and will evaluate the experimental vaccine’s safety and ability to generate an immune system response in healthy adults.
The pace of human safety testing for experimental Ebola vaccines has been expedited in response to the ongoing Ebola virus outbreak in West Africa.
Testing will take place at the NIH Clinical Center in Bethesda, Maryland.
The study is the first of several Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine and an experimental Ebola vaccine developed by the Public Health Agency of Canada and licensed to NewLink Genetics Corp.
The others are to launch in the fall. These trials are conducted in healthy adults who are not infected with Ebola virus to determine if the vaccine is safe and induces an adequate immune response.Continue reading →