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Liability Issues Complicate Smallpox Vaccination In a January 28 statement outlining the federal government’s policy concerning smallpox vaccination, U.S. Secretary of Health and Human Services Secretary Tommy Thompson did little to clear up concerns about whether health workers who volunteer to receive the vaccine will be entitled to compensation or treatment if they suffer ill effects. Noting that the attacks of September and October 2001 have heightened concern that terrorists may have access to the smallpox virus and attempt to use it against the American public, Thompson said administration of "smallpox countermeasures" is advisable for smallpox response teams, health care workers, and emergency response workers. Thompson pointed to liability protections in Section 304 of the Homeland Security Act passed by Congress last year, which lists manufacturers of vaccines, health entities, and qualified persons who administer vaccines as exempt from civil lawsuits. But Section 304 makes no mention of treatment or compensation for health workers who may become ill as a result of their smallpox vaccinations, an omission that caused nurses’ associations in California and Connecticut to advise members not to participate in federally sponsored vaccinations. Thompson’s statement conceded that vaccinating against smallpox is complicated. "Administration of a countermeasure such as smallpox vaccine is necessarily more involved than the act of placing a drop of vaccine on a two-pronged needle and inoculating a person’s arm," the statement said. "Determining who is contraindicated; monitoring, management, and care of the countermeasure site; evaluation of ‘takes’; and contact transmission of vaccinia, among other things, all arise out of and are directly related to and part of the administration of the countermeasure." The statement indicated that, based on scientific data from animal model studies, it appears the drug Cidofovir, which is used to treat viral infections in persons with HIV/AIDS, may also be useful in treating smallpox in humans. "Smallpox countermeasures" are described as including administration of vaccinia (smallpox) vaccines, including the Dryvax vaccine, and administration of vaccinia immune globulin, which is used to treat certain adverse effects of vaccination. Immunization Gets Congressional Attention In testimony before the Senate Health, Education, and Labor Committee January 30, Centers for Disease Control and Prevention Director Julie Gerberding explained the federal government’s actions to date on smallpox immunization, confirming that the first step is to form state and local volunteer smallpox response teams that can provide critical services in the event of an attack. "In the initial stage of vaccination," Gerberding said, "vaccine will be offered core members of public health and health care response teams. Then vaccination will expand to include health care workers and others who may be the first responders." She estimated that eventually some 450,000 public health and health care personnel may be offered the vaccine. Gerberding stressed that vaccination is voluntary and eligible individuals will make their own decisions as to whether or not to receive the vaccine. "There are no negative employment ramifications for anyone who chooses not to be vaccinated," she said. During the week of January 20, the CDC delivered enough vaccine and needles for 21,600 public health and health care workers to the states of Connecticut, Nebraska, and Vermont, and Los Angeles County in California, in the first step in the national immunization program. As of January 22, Gerberding indicated, 20 states have requested nearly 100,000 doses of vaccine. Anthony Fauci, the director of the federal government’s National Institute of Allergy and Infectious Diseases, told the Senate committee that the smallpox response teams and first responders will receive FDA-licensed Dryvax smallpox vaccine in undiluted form.The vaccine was made by Wyeth Laboratories and approximately 15 million doses have been in storage since 1982, when the company stopped making the vaccine. Dryvax is freeze-dried, live vaccinia virus, a poxvirus related to smallpox; it is not a dead virus as many other vaccines are. Smallpox vaccine is delivered by a technique called "scarification," Fauci pointed out, with the material is pricked into the skin using a two-pronged needle. Successful vaccination is measured by the development of a clear-cut pustule six to eight days after vaccination—known as a "take." The blister dries up and a scab begins to form; the scab falls off after about three weeks, leaving a scar. The immunization site remains contagious for vaccinia until the scab is gone and for that reason the vaccination must be cared for carefully to prevent the virus from spreading. Chief reactions to vaccination for most people are fever, malaise, soreness at the vaccination site, and swelling of the lymph nodes in the area of the vaccine, especially under the arms. For vaccinations in which there are more serious complications, Fauci said, the federal government currently has on hand more than enough Vaccinia Immune Globulin (VIG), a compound derived from the blood plasma of volunteers who have receive a smallpox vaccination, to treat any adverse reactions. What about Children? The American Academy of Pediatrics (AAP) believes that the general public, and especially children, should not be offered smallpox vaccination at this time, Dr. Jon Abramson told the Senate committee. Abramson, who chairs the AAP’s Committee on Infectious Diseases, said children would be particularly vulnerable to complications of vaccination because they have a high prevalence of atopic dermatitis, may have immune deficiencies that are not yet known, and are at greater risk of cross-inoculation in sites such as schools and day care centers. The AAP’s position against child immunization for smallpox is based on the information the government has provided about the small risk of a smallpox attack, Abramson stressed, and might change if the risk assessment changed. Abramson pointed out that no recent pertinent clinical trials have been done to determine if the currently licensed 30-year-old frozen Dryvax vaccine can safely be administered to children, and a new tissue culture-derived vaccine now being developed has never been tested in either adults or children. He urged testing of smallpox vaccines similar to that being done for other drugs that will be given to children, and he also urged Congress not to divert public health funds for smallpox immunization from programs such as control of tuberculosis and pertussis and support of childhood immunization clinics. A Call to Arms? In an editorial accompanying articles on smallpox in the January 30, 2003, issue of The New England Journal of Medicine, Drs. Terry Schraeder and Edward Campion noted that "The possibility of biologic warfare has entered the national psyche and vaccination against smallpox has begun. For physicians and other health care professionals, the current call to arms means more than rolling up our sleeves for the prick of a bifurcated smallpox-vaccine needle. It means making sensitive decisions for ourselves and giving important education and advice to our patients." "Health professionals are familiar with risk," they pointed out. "Doctors and nurses have responded during past crises to provide care for patients and help protect the public health, even when there has been significant personal susceptibility. From epidemic tuberculosis to radiation and contaminated blood, occupational hazards have always been part of treating patients. The complications of the smallpox vaccine will be both real and random. Fortunately, they will also be rare." For persons who received vaccinia decades ago when smallpox vaccination was routine for all children entering school, "there is now more concern about decisions to use this vaccine, with greater awareness of the risks and less trust in recommendations about vaccines in general," they said. "A core group of first responders, who are being vaccinated, have accepted the small degree of risk to help protect the health of the public." An extensive report from the Centers for Disease Control and Prevention,
"Smallpox Vaccination and Adverse Reactions: A Guide for Clinicians,"
was released in electronic form January 31, 2003, at http://www.cdc.gov/mmwr/mmwr_dispatch.html
and will be published in a future issue of Morbidity and Mortality Weekly
Report. Researchers Wonder—Is Marijuana a ‘Gateway’ Drug? It’s a widely held theory of drug use and abuse that there are stages of progression, from tobacco and alcohol to marijuana and from marijuana to other illicit drugs. Studies of drug abusers seem to bear the theory out: "Very few individuals who have tried heroin and cocaine have not already used marijuana and the majority have already used tobacco and alcohol," says Denise Kandel, a researcher in the Department of Psychiatry at Columbia University. But Kandel and fellow researchers wondered--does using cannabis (marijuana) cause people to move to more potent drugs, or is something else going on? We know that not every person who uses marijuana becomes addicted to heroin or cocaine. Are there genetic risk factors or environmental conditions that lead some marijuana users to more powerful drugs? That’s a hard question to answer. Researchers have used animals to study the biological processes that are involved in drug use behavior, but no rat or mouse is subject to the variety of cultural, social, and psychological factors that determine drug behavior in human beings. "Only in a human can one explore the many other social, psychological, and contextual factors that are also important in drug use behavior," Kandel points out. Looking for a way to examine those human factors, a group of Australian and American researchers surveyed some 4,000 young adult Australian twins, both fraternal and identical, who were brought up together. The young people were asked about the age at which they first tried marijuana and their subsequent nonmedical use of prescription sedatives, hallucinogens, cocaine, and opiods. They were also asked whether they had become dependent on any of those drugs, or on cannabis or alcohol. A total of 861 members of the sample reported initiating marijuana use before the age of 17 years. Of these, 311 were from same-sex twin pairs in which the other twin had not used cannabis by age 17. The researchers then analyzed lifetime drug use reported by both the early users and their twins. The result: "Early initiation of cannabis use was associated with significantly increased risks for alcohol and other drug use and abuse/dependence and was associated with significantly increased risks for other drug use and abuse/dependence." Specifically, individuals who used cannabis before 17 years of age had a 2.3 to 3.9-fold increase in the odds of becoming alcohol and other drug dependent—and this was true whether they were fraternal twins who had the same family background or identical twins who had the same genes. If early use does indeed cause later problems, the researchers conceded they don’t know how that happens. Perhaps early use causes subtle biochemical changes that encourage further drug-taking, or perhaps seemingly safe early experiences with marijuana reduce the perceived risk from use of other drugs. And early cannabis users may have access to other drugs as a result of their contacts with drug dealers. Whatever the connection, the researchers pointed out, "It is apparent that young people who initiate cannabis use at an early age are at heightened risk for progressing to other drug use and dependence." This makes it important, they said, to develop interventions to prevent escalation to other drugs for young people who are identified as being at risk for early initiation of marijuana use. The research report, "Escalation of Drug Use in Early-Onset Cannabis Users vs. Co-twin Controls," and an accompanying editorial, "Does Marijuana Use Cause the Use of Other Drugs?" appeared in the January 22/29 issue of the Journal of the American Medical Association. Reprints of the research report are available from mlynskey@matlock.wustl.edu. -------------------------------------------------------------- Commonly Abused Illicit Drugs: A Glossary of Names and Effects The National Institute on Drug Abuse (NIDA), a division of the federal government’s National Institutes of Health, has published a glossary of commonly abused illicit drugs, by substance categories, with their commercial or street names and their intoxicating effects and possible health consequences. Here is NIDA’s catalog of information about drugs that are used and
available in the United States. For further details about each of the
substances, NIDA can be contacted at www.drugabuse.gov.
-------------------------------------------------------------- IN CONGRESS Current Year Appropriations Still Unclear The 108th U.S. Congress, which convened in January, inherited a lot of money problems from its predecessor, the 107th Congress, which adjourned without passing major appropriations bills, including fiscal year 2003 funding for health programs. And the 108th isn’t doing much better—on January 30 the House and Senate agreed to fund the entire government for the next nine months on a "continuing resolution" that holds many programs at last fiscal year’s level. During two days of debate, both the House of Representatives and the Senate added some amendments to the continuing resolution, mostly benefiting lobbying groups that pressed for additional funds or new initiatives. Now, the two houses have agreed to go to conference to work out differences between their versions of the money bill. Meanwhile, President Bush in his State of the Nation address made little mention of domestic health policy, except to propose that the Medicare program be changed to allow Medicare recipients to receive prescription drug benefits if they agree to join private health plans. Health Bills Are Introduced In the opening days of the new Congress, members introduced the following health-related legislation. In the Senate:
In the House of Representatives:
Two comprehensive health bills have also been introduced. In the House, Representative John Dingell (D-MI) introduced the National Health Insurance Act, H.R. 15, which calls for a national health care trust fund to be financed by a value-added tax. In the Senate, Senator Thomas Daschle (D-SD) introduced S. 10, described as "A bill to protect consumers in managed care plans and other health coverage, to provide for parity with respect to mental health coverage, to reduce medical errors, and to increase the access of individuals to quality health care." To follow any of these or other bills in detail, go to website www.thomas.loc.gov, where you can enter the bill number to access the text and status of legislation. -------------------------------------------------------------- WORTH NOTING Adolescent Care and Confidentiality in Pediatric Practices Pediatricians are even less likely than family practitioners or internists to understand the privacy rights of adolescent patients who seek treatment for "medically emancipated" conditions such as pregnancy /contraception, sexually transmitted diseases, substance abuse, and mental health, according to researchers who surveyed medical practitioners in a three-state area near Washington, D.C. Writing in the February 2003 issue of the journal Pediatrics, the researchers said they found a high proportion of pediatricians are uncomfortable with providing services for those conditions or with giving adolescents confidential care, even though every state has laws that to one extent or another entitle adolescents to such care and to confidentiality. They also found that often the receptionists in doctors’ offices who answered the telephone when teenagers called for appointments were unaware of the rules about adolescent confidentiality and gave inaccurate information to the callers. The researchers called for better training of pediatricians in adolescent care and the importance of confidentiality. Pediatric Endocrinologists Wanted To enlarge the pool of pediatric endocrinologists conducting research in childhood diabetes, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDKD) has made awards to seven medical centers to support advanced training for physicians who will serve as teaching faculty and clinical researchers. The need for pediatric diabetes research reflects the growing incidence of diabetes in children. About one million persons in the United States have type 1 diabetes, formerly known as juvenile onset or insulin-dependent diabetes. Type 2 diabetes, formerly seen only in adults, has been rising steadily in children, especially minority adolescents, with some 30 to 50 percent of children with newly diagnosed diabetes now believed to have type 2, in which the body fails to utilize insulin effectively. The NIDDKD awards went to Baylor College of Medicine in Houston, the University of Colorado Health Sciences Center in Denver, Washington University School of Medicine in St. Louis, Joslin Diabetes Center in Boston, Children’s Hospital of Pittsburgh, Children’s Hospital of Philadelphia, and Yale University. Which Adolescents Are Most Vulnerable to Tobacco Ads? Disengagement from school has long been associated with youth smoking, but researchers now say doing poorly in school and having low academic aspirations also makes teens more vulnerable to tobacco advertising. Messages conveyed by cigarette ads—that smokers are attractive to the opposite sex, adventurous, popular, risk-taking, and independent--have "symbolic significances" for all teenagers but especially for youths who are unhappy at school, according to a study published in the February 2003 issue of the journal Pediatrics. "Tobacco marketing may be particularly powerful for adolescents who exhibit psychosocial vulnerabilities and seek the kind of identity that the smoking images are carefully designed to offer them," researchers reported. Long-Term Evaluations of DARE DARE, the Drug Abuse Resistance Education program funded by a variety of private, federal, and public entities is offered free to schools and is usually introduced in fifth and sixth grades. The curriculum, a series of 17 lectures presented by uniformed police officers, aims to prevent use of illicit drugs by giving students the information and skills needed to resist drug use. But in a January report to Congress, the U.S. General Accounting Office reported that long-term evaluations of the DARE elementary school curriculum found no significant differences in drug use 10 years later between students who received DARE in fifth and sixth grades and those who did not. "All of the evaluations suggested that DARE had no statistically significant long-term effect on preventing youth illicit drug use," the GAO said. The report, "Youth Illicit Drug Use Prevention: DARE Long-Term Evaluations and Federal Efforts to Identify Effective Programs," also lists examples of effective drug-abuse prevention programs recently identified by the Substance Abuse and Mental Health Services Administration (SAMHSA). The report is available at www.GAO.gov.
January News Alerts The following information appeared during the month of January 2003 in the News Alerts section of this website. RWJ Foundation Offers Grants to Improve Active Living Active Living by Design, a $16.5-million national program of the Robert Wood Johnson Foundation, promotes changes in local community design, transportation, and architecture that make it easy for people to be physically active. Health care coalitions are among those who may apply for grants of up to $200,000 over five years to develop and implement strategies for increasing opportunities for and removing barriers to routine physical activity. Applications may be filed from January 6 to January 31, 2003. For details, see website www.activelivingbydesign.org. (For additional RFPs in health, visit http://fdncenter.org/pnd/rfp/cat_health.jhtml.) Grants Available to Massachusetts Health Organizations Blue Cross Blue Shield of Massachusetts will make grants to Massachusetts health delivery organizations to help remove barriers to health care for state residents who come from diverse cultures, particularly low-income and uninsured populations. One-year grants of from $15,000 to $50,000 are available to applicants to implement new initiatives or expand existing programs. For complete information and application guidelines, see the BCBSMA Foundation website at www.bcbsmafoundation.org. Report Targets 20 Key Areas to Improve Health Care System The U.S. Department of Health and Human Services and other public and private stakeholders should focus on 20 priority areas in order to improve health care quality and delivery for all Americans, according to a report released January 7 by the Institute of Medicine. The 20 domains, which range from broad interventions to preventive services and palliative care for the dying, are presented in alphabetical order and are not ranked by importance.
The Institute of Medicine report, "Priority Areas for National Action: Reforming Health Care Quality," will be available online at http://national-academies.org. Health Care Spending Reaches $1.4 Trillion Sparked by rapidly growing Medicaid, hospital, and prescription drug spending, U.S. health care costs reached $1.4 trillion in 2001, up from $1.3 trillion the previous year, the fastest rise in a decade. An annual report on health care spending released January 8 by the federal Centers for Medicare and Medicaid Services ties the growth in health care expenditures to increases in hospital and drug spending, accelerated Medicaid spending, and the diminishing effects of managed care. The total Medicaid budget grew to $224.3 billion in 2001, exclusive of Medicaid increases enacted by states as part of the State Children’s Health Insurance Program (SCHIP). The growth in Medicaid spending was fueled by an 8 percent rise in enrollment caused by the recession, expanded state programs for uninsured persons and relaxed eligibility standards, and increased use by states of Medicaid "loopholes" to close funding gaps. The government report, "Trends in U.S. Health Care Spending, 2001," will be available at www.cms.hhs.org. Funds Available for Conference Support The Centers for Disease Control and Prevention (CDC) announced January 10 that it expects to make approximately $1.1 million in available in fiscal year 2003 for approximately 60 to 80 awards averaging $20,000 each, to partially support non-federal conferences in the areas of health promotion and disease prevention information and education programs and applied research. Applications may be submitted by public or private entities, including state and local governments, foundations, voluntary associations, faith-based organizations, civic groups, scientific or professional associations, universities, or tribal governments, for conferences to be held between July 1, 2003, and September 30, 2004. Also available is approximately $50,000 from the federal Agency for Toxic Substances and Disease Registry (ATSDR) to support conferences that deal with hazardous substances and environmental health research, education, and application. Applicants may include official state public health agencies, state universities and research institutions, and nationally recognized associations of health professionals. ATSDR expects to fund approximately six awards ranging from $5,000 to $10,000 each for a 12-month period. Letters of intent are due by March 1 and the application deadline is May 1. For further information, see the Federal Register for January 10, 2003.
Pediatric Tests Planned for Drugs Prescribed for Children The U.S. Department of Health and Human Services announced in January that tests will begin this year on 12 drugs that are commonly prescribed for children although they were never tested for their effects on children. The tests are mandated in the Best Pharmaceuticals for Children Act, which became law last year. The 12 highest-priority drugs needing pediatric review, according to HHS, are:
Each drug will undergo about two years of testing in children, followed by evaluation of test results by the Food and Drug Administration. None of the drugs is currently under patent and therefore does not belong to any one pharmaceutical company, so the government will pay for the tests. For drugs with existing patents, the Best Pharmaceuticals for Children Act offers the manufacturers extended market exclusivity if they agree to do pediatric testing.
Nursing Enrollments Do Not Meet Demand for New Nurses An annual survey by the American Association of Colleges of Nursing (AACN) found that enrollments in entry-level baccalaureate programs in nursing increased by 8 percent in 2002 over 2001, at a time when the need for nurses with baccalaureate and graduate degrees is expanding in the U.S. health care system. But the number of students in the educational pipeline is still insufficient to meet the projected demand for a million new nurses over the next 10 years, according to the AACN, which notes that a shortage of registered nurses is already impacting the delivery of health care in the U.S. The shortage is expected to intensify over the next decade as baby boomers age and a large percentage of the current nursing workforce retires. A report, "2002-2003 Enrollment and Graduations in Baccalaureate and Graduate Programs in Nursing" will be available in February. The AACN can be contacted at www.aacn.nche.edu. Health Workers’ Smallpox Immunization Gets off to Shaky Start Not many health workers turned up for smallpox vaccinations in Connecticut January 24, after the state nurses’ union advised waiting for liability issues to be resolved. Connecticut was one of three states and one county that received the first shipments of smallpox vaccine and vaccinator needles from the Centers for Disease Control and Prevention, in the opening phase of a nationwide program that hopes to vaccinate 500,000 health workers so they could treat patients in the event of a smallpox terrorist attack. Health and Human Services Secretary Tommy Thompson said the federal government is working with state and local public health officials and thousands of participating hospitals to mobilize response teams so they would be able to vaccinate others and provide critical services in the days following an attack. Vaccination is voluntary, and many health workers are said to be concerned about reports of serious reactions to the smallpox vaccine.
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