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The Senate Health, Education, Pensions and Labor Committee this morning examines the divide between parental rights and public health requirements when addressing vaccines for preventable diseases. The session will feature mostly pro-vaccine witnesses to discuss the safety and efficiency of vaccines in the wake of a recent outbreak of measles and the re-emergence of vaccine preventable diseases. The hearing will weigh the option of pressing individual states to act on vaccination requirements or developing federal vaccine mandate legislation.
A House panel broached the subject in a hearing last week that focused on separate concerns about the effectiveness of the annual influenza vaccine. Ironically, this year’s mismatched flu vaccines, which are only 23 percent effective, are not directly pressed by people seeking to opt out of vaccination. Conversely, the measles vaccine is almost completely effective after 2 doses.
Congressional committees this week engage a variety of health care topics. Leading-off is a Tuesday Senate hearing on the public health challenge of the re-emergence of vaccine preventable diseases, particularly measles.
Starting on Wednesday, the House Energy and Commerce Committee plans to conclude committee approval of a batch of health bills. The committee holds a two-day mark up session on measures regulating (HR 638) and managing (HR 471) controlled substances and renewing trauma systems programs (HR 647 and HR 648). Also, House Appropriations Committee panels begin the early examination of the fiscal 2016 spending bills. First on the agenda this week is the Indian Health Service and oversight of funding allocated to respond to the Ebola virus outbreak, plus an initial budget review session on veterans’ health programs.
Examining HHS Efforts on Mental Health and Disease Codes
Separately, two House committees on Wednesday review new Government Accountability Office reports critiquing the Department of Health and Human Services. An oversight committee examines a report on HHS leadership on mental health programs (view GAO report released on Feb. 5) and the health subcommittee examines HHS implementation of new health care disease codes (view GAO report released on Feb. 6).
Additionally, committees mull the GAO’s efforts to monitor high-risk programs in Senate morning and House afternoon sessions on Wednesday. House Science, Space and Technology panels on Thursday mull privacy expectations for information shared on the federal health insurance exchanges.
This year’s flu season is not only severe – with increasing hospitalization rates – but the selected annual influenza vaccine is not as effective. The Centers for Disease Control and Prevention on Thursday announced that the seasonal flu vaccine is only 23 percent effective against the current strains of the influenza virus. The rate is well below the typical effectiveness rate of 60 percent.
The annual assembly process for the standard set of vaccines is complex and attempts to predict the expected influenza types, but the science is not exact. Also, the determination of the annual vaccine must be done months in advance in order to allow time to manufacture large quantities of the vaccine. This year’s vaccine was met with unexpected strains of the virus. As a result, the health agency is recommending the use of anti-viral drugs as an adjunct to vaccination.
On any given day, about 1 in 25 hospital patients gets an infection. The statistic comes from the Centers for Disease Control and Prevention, which on Wednesday updated its annual progress report on efforts to combat healthcare-associated infections.
Hospitals have ramped up efforts to control infections from various sources. Reducing infections improves patient survival rates and also offers substantial health system cost savings. The annual CDC report breaks down individual state efforts to reduce infections and cites a 46 percent decrease in central-line caused blood infections and a 19 percent drop in surgical infections. Smaller decreases were noted in other types of infections but catheter-associated infections increased.
A pivotal tool in the fight against the Ebola virus is the development of a vaccine, which could stem the spread of the current outbreak in West Africa and entice healthcare workers to assist in future outbreaks of the virus. U.S. health agencies and $5.4 billion in emergency supplemental funding to address the Ebola outbreak has helped to spur the development of new potential vaccines.
Several potential vaccines are headed toward clinical trials in Africa but the process of testing a vaccine is complex. On Monday, the University of Minnesota’s Center for Infectious Disease Research and Policy and the Wellcome Trust released a report describing the primary principles for the development of an Ebola vaccine and offers road map for vaccine testing.
Other related recent reports:
The 2014-2015 flu season is severe and the Centers for Disease Control estimates that this year’s primary influenza strain has already jumped the senior citizen hospitalization rate from 52 to 92 per 100,000 persons.
CQ HealthBeat’s (@CQHealthTweet) Kerry Young reports that the CDC has admitted that there is a mismatch this year between the strains of flu targeted in the vaccines made for the 2014-2015 season and ones detected in actual circulation. As a result, the CDC is recommending the use of anti-viral drugs as an adjunct to vaccination.
Also, the focus on the vaccine mismatch and the severity of the flu season has prompted the health agency to call for a universal vaccine that would work far more broadly than current vaccines to prepare people’s immune systems ward off the influenza threat. Health officials claim that the concept of a universal vaccine has been demonstrated but vaccine scientists are several years away from general availability of a universal vaccine.
The Ebola virus continues to ravage several West African countries. The origins of the current version of virus appears to have started as the result of a small child playing with fruit bats living in a hollowed out tree near a village in Guinea around March 24, 2014.
German scientists last week published a study examining the possible first case of Ebola keyed to a 2-year old boy in the Guinea village of Meliandou who came in contact with fruit bats. The study suggests that the boy’s exposure to the bats, not previous suggestions of villagers eating the meat from fruit bats, was the first instance of the transfer of the current virus from animals to humans.
A fertility technique that can produce “three-person embryos” to prevent women from passing on rare genetic diseases has drawn the attention of lawmakers who set the budgets for federal agencies including the Food and Drug Administration.
At issue is mitochondrial manipulation, in which genetic material from one woman can be moved into the egg of another. This technique has been developed to help women who otherwise would risk passing on rare mitochondrial diseases to their children, but there’s some thought that it also may aid older women seeking to become mothers.
The devastating Ebola outbreak exposed problems in the public health infrastructure in West African countries. How does the U.S. health system stack up in capability in responding to a health emergency?
The Association of State and Territorial Health Officials this week unveiled its annual ranking of state preparedness levels. The National Health Security Preparedness Index™ seeks to gauge preparedness levels on a range of factors including planning, surge capacity, incident reporting and environmental health. The updated 2014 index tags the U.S. preparedness level at 7.4 on a 1-10 scale.
Overall, the report appears to give a relatively good national estimate of preparedness but individual states have different ratings. Rankings for Alaska are below the national average for most preparedness components, while New York ranks above the national average. Overall, the lowest emergency preparedness ranking for most states relate to food and water security and environmental monitoring.
The Department of Health and Human Services today officially declared that three new Ebola vaccines are now protected under special emergency health-response preparedness rules. The ruling provides immunity against legal claims related to the manufacturing, testing, development, distribution, and administration of the vaccines. The special legal protection is designed to encourage vaccine development and it offers a separate compensation program for eligible individuals who sustain an injury as direct result of the vaccine.
Meanwhile, the National Institutes of Health on Tuesday announced that several non-Ebola vaccines developed by federally sponsored research are available for licensing. Leading the list is a new vaccine for Shigellosis, which is an intestinal disease that affects 200 million people and causes 650,000 deaths each year. The licensing offering includes other vaccine adaptations, plus a method of using Salmonella — normally a disease to be avoided and frequently associated with food safety concerns — as a delivery system for a therapy to combat brain cancer.
Various organizations and governments on Monday commemorated World AIDS day and issued statements on global efforts that are beginning to slow the spread of HIV/AIDS. President Obama noted a decrease in the number of new infections worldwide and praised the work of the President’s Emergency Plan for AIDS Relief.
While progress in stemming HIV/AIDS has been aided by broad international programs, other more focused projects are also coming online. The National Institutes of Health on Monday touted the development of a low-cost, electricity-free device that can detect infectious diseases. The mobile device, which relies on power from a chemical reaction, produces an accurate test result in 80 minutes in remote areas that lack reliable electricity. Early detection of some diseases, particularly HIV/AIDS, is pivotal to quickly and cost-effectively starting a treatment program. The ingenious device was developed, in part, through NIH grants.
A House Energy and Commerce Committee panel this morning examines domestic health system preparedness for treating Ebola patients. The committee quizzes FDA Commissioner Tom Frieden, plus other HHS officials on readiness to handle patients with the Ebola virus. The session also features the chiefs of Texas and Nebraska hospitals that have treated Ebola patients.
At the same time this morning, a nurse advocacy group, which held a vigil at the White House last week to raise awareness about concerns of woeful health facility preparedness policies for health professionals, takes its case to steps of the headquarters of the Department of Labor’s Occupational Safety and Health Administration.
This afternoon, a House Foreign Affairs Committee panel hears the perspective of several private groups who have been providing health services to Ebola patients in West Africa. Witness at the hearing include representatives from International Medical Corps, Global Communities and Africare.
Congress this week is busy negotiating options and a pathway toward a year-end spending package. However, a wide range of committees also catches up on reviews of U.S. activities and conditions in West Africa regarding the outbreak of the Ebola virus. A Senate committee on Wednesday is poised to advance a bill that adds Ebola drugs to an existing FDA priority drug review program. Additionally, a separate Senate committee mulls overall public health preparedness concerns with FDA Commissioner Thomas Frieden.
Meanwhile, two House Energy and Commerce panels review Ebola response efforts with Frieden and the status drug development activities with National Institute of Health officials. Another House panel this week discusses efforts by private groups battling the virus in West Africa.
Congress this week returned from the longest election recess break since 1960 and immediately began posturing on an upcoming spending bill and other possible available options for the lame duck session. A temporary extension of fiscal 2015 spending expires on Dec. 11. Congressional appropriators spent the week urging passage of a complete full-year spending package, which would include funding for health agencies and programs. Alternatively, some Republicans suggest a further spending bill extension, which would shift spending decisions into January.
The U.S. had no Ebola patients for only a few days this week. Following the release of a NY physician on Tuesday, a new patient from Sierra Leone arrives in Nebraska on Saturday. The administration’s emergency funding request for Ebola response activities, both in West Africa and domestic preparedness was examined on Wednesday in a Senate hearing (view Roll Call video). Separately, a House committee hearing on Thursday largely supported emergency funding to help the State Department respond to the Ebola outbreak in West Africa.
The biggest threat to the Ebola funding request appears to be if Congress resorts to a further extension of stopgap spending instead of a complete omnibus measure due to political pressures. In that case, a portion of the extra Ebola funding would likely be tacked onto a stopgap continuing resolution. However, the entire spending bill package is also threatened by possible Republican reaction to any White House action on immigration policies.
Meanwhile, a Senate committee this week set up a pathway for action on a measure (S 2917) adding Ebola drug research to an existing FDA drug development program. Action over the next few weeks is also possible on a bill (HR 5059) seeking to reduce veterans’ suicide rates. Also, the House on Thursday completed voting — and sent to the President — a bill renewing traumatic brain injury research programs (S 2539) and a measure urging the FDA to expedite the approval of sunscreen ingredients (S 2141).
House and Senate committees this week return to examination of the U.S response to the Ebola virus outbreak in West Africa and a review of domestic public health preparedness plans. Senate appropriators on Wednesday afternoon seek details from Health and Human Services Secretary Sylvia Mathews Burwell and the HHS Ebola response duo of FDA Director Thomas Frieden and Anthony Fauci the director of National Institute of Allergy and Infectious Diseases, plus State and Homeland Security department officials. On Thursday the House Foreign Affairs Committee also examines international Ebola response efforts in West Africa.
The White House last week requested $6.18 billion in additional funding. The formal request includes $2.4 billion for Department of Health and Human Services agencies, with the bulk of funding directing toward Centers for Disease Control and Prevention efforts to respond to the outbreak and other infectious disease threats. The White House also seeks $2.1 billion for the U.S. Agency for International Development for humanitarian assistance; $157 million for the Biomedical Advanced Research and Development Agency to manufacture vaccines for clinical trials; and $112 million for the Defense Advanced Research Projects Agency research on the virus. Other funding will be held in a contingency fund pending further developments of the epidemic (view White House fact sheet). The funding is in addition to $88 million in CDC and drug development funds approved by Congress earlier this year and $750 million in reprogrammed Pentagon spending for a West African relief mission.
Also this week, the House Veterans Affairs Committee honors Veterans’ Day sentiments in a hearing on recently enacted legislation expanding veterans’ health care treatment options.
Separately, a new enrollment period for health insurance exchanges begins on Nov. 15 but you can see plan data online starting today. The Centers for Medicare and Medicaid Services says that early look at plan details will assist consumers prior to beginning the formal enrollment process.