January 2002

Crisis Response Puts Agencies On Path To Better Coordination -

In view of the Sept. 11 terrorist attacks on the World Trade Center and Pentagon and subsequent anthrax mailings in the United States, it's hard to remember that the mass of tragedies that occurred in 2001 actually began in January when a devastating earthquake left some 25,000 dead in West India and dozens of health care facilities destroyed there.

The U.S. Department of Defense provided supplies and medical assessments to the area, and India's government assembled 250 mobile health teams that worked to provide care to refugees and contain sewage spills to limit the chance of water borne disease outbreaks from the damage left by the Jan. 26 quake, which also affected Pakistan and was felt as far away as Nepal.

Both the public and private health care worlds received some much better news in February when the National Institutes of Health International Human Genome Sequencing Consortium and the private firm Celera Genomics simultaneously published their draft results of a 90 per cent completed sequence of the human genome. NIH's ongoing project results are placed in a public database (Genbank), which allows the scientific community to readily view them and understand the biologic and tertiary actions between proteins that are the bases for what life is made of. The genome sequence provides researchers with the ability to find disease genes of unknown biochemical function by positional cloning. At least 30 disease genes have been positionally cloned in such efforts, and the genome sequence further expands the search on the part of the pharmaceutical industry for suitable drug targets.

In March a report released by the Institute of Medicine (IoM) found that the U.S. health care system is faltering in its ability to provide across-the-board quality care and needs to undergo "major changes." The report called on Congress to help fund improvements in health care quality, equity, safety, timeliness, efficiency and patient-centered care and for the Department of Health and Human Services to monitor and track the improvements. A follow-up to a November 1999 IoM report on patient safety, it also advised the Agency for Healthcare Research and Quality to generate a list of 15 or more common, mostly chronic health conditions that should become priorities for health care professionals.

DoD launched its new "TriCare for Life" benefits with the Senior Pharmacy Program in April, filling some 237,000 prescriptions in the first week of operation. Required as part of the 2001 defense bill, the program benefits military retirees and dependents 65-years old or older (who are eligible for medicare part A and enrolled in part B) by standardizing copayments, lowering the cost of generic medications and out of pocket expenses. The program's health care phase was launched later in the year with TriCare acting as second payer to medicare for medicare-eligible retirees, their family members and survivors. Although there have been some glitches during the inception of such a large, new program, some beneficiaries have reported positive results.

In a court-martial case that pitted issues of national security against vaccine safety and personal choice, the Air Force in May convicted Capt. John Buck, USAF, MC, for refusing a direct order in the previous year to take the anthrax vaccine in preparation for potential deployment to Bahrain. The only military physician who refused to take the vaccine, Dr. Buck claimed that DoD uses it in an off-label fashion because the Food and Drug Administration approved it for only cutaneous and not inhalational anthrax. DoD and FDA both asserted, however, that there was no distinction on the vaccine's labeling or license. Dr. Buck was denied a request to present testimony disputing the legality of the order to take the vaccine, as well as its safety and efficacy. He claimed the vaccine should be deemed investigational. Dr. Buck was then denied a request to resign and was subsequently found guilty and sentenced to 60 days of restriction at Keesler AFB, forfeiture of $1,500 in pay over 14 months and given an official reprimand. Critics of the vaccine assert that some have left service to avoid a vaccine they say causes rare but serious side effects, while DoD asserts that only one to five per cent of the 395,000 servicemen who received the vaccine for force protection experience local reactions.

Meanwhile DoD's Anthrax Vaccine Immunization Program was forced to downscale its production for the third time in two years, citing continuing production problems at the Lansing, Mich.-based BioPort contracting facility. In June, DoD decided to conserve its remaining 30,000 anthrax vaccine doses for special operations troops until the program can resume. Although BioPort completed several upgrades required to regain FDA approval to manufacture the vaccine, the Sept. 11 events have delayed the review process and the contract will be carefully re-examined.

The middle of the year also featured several discussions about the need to step up sharing and integration of resources between the Departments of Defense and Veterans Affairs. A General Accounting Office report concluded that continued and expanded joint procurement of pharmaceuticals by the two agencies, particularly in the purchasing of brand name drugs, could result in hundreds of millions of dollars a year in savings. At around the same time a new Presidential task force was formed to develop recommendations over the next two years to improve health care to veterans and military retirees through increased coordination between DoD and VA. Joint testimony at a June congressional hearing emphasized that the two agencies have achieved only modest success in integrating their medical capabilities because they sometimes lack common incentives.

The Department of Health and Human Services in July released a guidance to answer questions for public and private health providers and plan administrators who are trying to determine how to implement a new patient privacy regulation issued the previous year under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In a decision that reflects the changing nature of the physician-patient relationship as well as the increased flow of medical information over the Internet, the regulation gave patients more control over their medical information and required physicians to obtain patient consent before they can share their records for payment, treatment and other health care purposes. But HHS officials said they would continue to modify the regulation through the implementation period to address concerns that some components of it would be nearly impossible to implement.

The potential of embryonic stem cells to develop into multiple kinds of cells and eventually lead to cures for diseases such as Parkinson's, heart disease, diabetes, Alzheimer's and spinal cord injury, was the subject of debate for many months before President Bush decided in August to allow federal funding of research on such cells created only prior to Aug. 9. The decision will allow researchers working with federal funds to have access to about 70 stem cell lines. The decision was reached after a lengthy political debate that pitted hard-line right to life conservatives, opposed to any such use of embryonic cells, against those who advocated for a wider availability of such cell lines derived from human embryos that are slated to be discarded in fertility clinics.

The events of September 11 thrust local emergency medical service workers, firefighters, civilians and military personnel alike into the sudden and horrifying roles of battlefield medics. The Department of Defense coordinated the response to the attack at the Pentagon, where workers evacuated from inside the building and some civilian bystanders sometimes worked side by side with Arlington County and military medical personnel to rescue survivors from the burning building, give aid to the injured and carry them away in litters. A makeshift heliport was established nearby, and the Air Force evacuated the most seriously injured to area hospitals.

At the New York crash scene, federal health agencies provided contingency support with the Manhattan VA medical center treating about 50 casualties and the VA medical center in Brooklyn handling three cases. Two Navy reservists on the scene assisted in the initial triage and care of victims and the Naval hospital ship U.S.S. COMFORT arrived the next day to provide support and care for the firefighters and other rescue workers who needed treatment for minor injuries or simply a place to eat, shower and rest. The Armed Forces Institute of Pathology was dispatched to conduct DNA testing and extensive analyses to identify victims from the Pentagon, New York and Pennsylvania crash sites.

DoD's reponse to the attacks was aided by the fact that department medical personnel had carried out a simulation exercise in May in which a hijacked 757 airliner crashed into the Pentagon. The Tri-Service DiLorenzo Health Care Clinic and the Air Force Flight Medicine Clinic in Washington, D.C., fine-tuned their emergency preparedness after the exercise by making simple equipment changes that eventually helped when the real attacks took place.

The VA provided post-traumatic stress counseling to victims and physicians alike following the attacks, and VA and DoD began to prepare for the possibility of another attack, including one with chemical or biological weapons. Although better coordination between federal agencies in assuring the availability of vaccines with limited markets (including those that could be used for bioterrorism) was urged several months earlier, the first cases of anthrax exposure that arose in October forced agencies to work even harder to combine their resources to deter, detect, identify and respond to further cases.

The Centers for Disease Control and Prevention and state public health officials reported the initial case of inhalational anthrax in Florida. HHS set up a command center to coordinate bioterrorism surveillance and reponse efforts, and the White House quickly established an Office of Homeland Security to provide overall leadership and coordination of federal programs to combat all forms of terrorism and develop a formal process to evaluate interagency lessons learned from major federal exercises. The National Institute of Allergy and Infectious Diseases, CDC, FDA and DoD bolstered efforts to address the continuous anthrax threat, as well as other potential outbreak threats like smallpox, plague and hemorrhagic fever. Congress approved funds to stockpile millions of treatments for anthrax and millions of doses of smallpox vaccine.

Some agencies also discussed the need to prevent and prepare for the possible contamination of food and other products.

Just as the anthrax toll mounted to over a dozen cases in multiple states and federal workers, postal servicemen and members of Congress were administered nasal swabs to detect exposure, and antibiotics for treatment, Navy medical corpsmen and other medical support elements for Marine or Special Operations forces onshore were deployed to the Afghanistan region to participate in Operation Enduring Freedom, which has continued to rage through November and December. While those operations continued, America prepared for the possibility of more attacks at home. VA's vet centers also provided counseling to veterans who may have been reminded of their past traumatic experiences by the terrorist attacks. In addition, VA has begun to prepare for the possibility of treating a new wave of veterans from the Afghanistan conflict and is trying to capitalize on lessons learned from Vietnam and Persian Gulf veteran patients by preparing for unique health problems that they may encounter.

CDC also issued a "model law" to guide states in modernizing public health laws so they can better manage potential bioterrorism attacks.

However, the heightened sense of caution and readiness must be balanced with the many other health initiatives, improving medical technologies and translational research taking shape in the public and private arenas.

Technologies now being utilized by VA, such as bar coding, handheld and laptop computers, electronic medical records, telemedicine and virtual reality are being used to improve communication among healthcare providers, reduce medical errors and improve health care quality and access.

VA's National Center for Patient Safety was the only federal program to win an "Innovations in American Government" award from Harvard University this year. A confidential mistake reporting system that encourages physicians to report and discuss close calls and mistakes without fear of punishment, the program is used to identify these mistakes and correct underlying problems to prevent them from reoccurring. VA will receive a $100,000 grant to further the program and inform other health care providers of its usefulness.

The National Cancer Institute is using new technologies such as functional imaging, high performance computing and molecular targeting to visualize changes in genes and cellular functions and help target existing therapies and new drugs to attack cancer cells while sparing healthy tissue.

Furthermore, in the last fiscal year FDA approved 71 new drugs, 16 biological license applications and 53 premarket approvals for new devices with new technologies or new uses.

NIAID released a Global Health Plan for reducing the cases of HIV/AIDS, tuberculosis and malaria over the next decade. This will encompass the development of vaccines and drugs to treat these diseases and strengthening research capabilities.

The Federal Aviation Administration is trying to improve care on board commercial flights by adding enhanced medical kits and automated external defibrillators to respond to in-flight health emergencies.

The Surgeon General released a report recently on the problem of obesity in America, which may begin to be viewed as a "societal" problem that requires a rethinking of our lifestyles and how we utilize the environment around us.

As progress is made in health care and research, adequate staffing levels also need to be maintained. Nursing unions and advocates expressed concern last year that more nurses were needed at VA and that an imminent nursing shortage had already arrived. Although officials said overall nurse employment at VA was stable, they agreed that there are some nurse specialties and geographic areas that are experiencing problems. Furthermore, HHS projections this year show that, under the current trend, demand for nurses will surpass supply by 2010 and that, by 2015, 114,000 full-time RN positions will be unfilled in America for a variety of reasons. HHS took a step toward addressing the problem in late September when it awarded $27.4 million in grants to 82 educational institutions, including $7.3 million for educational loan repayments, to help combat the coming shortage by increasing recruitment and nursing education incentives.

As a result of legislation passed in late 2000, agencies such as NIH are now attempting to improve access to health care among minorities and eliminate health status disparities. Center designations will be established to conduct research and training, as well as measure health disparities and identify causes and remedies.

Living in a world perhaps as uncertain as ever is no easy task, but if people continue the effort to communicate and coordinate on finding solutions to problems the task will become easier. In the pages of this issue many of the leaders of our federal health agencies discuss their healthcare and research activities in 2001, their responses to the terrorist crises and what programs and initiatives we can expect to see in 2002.

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