Pediatric Drug Testing Struck Down by Court
An effort by the federal Food and Drug Administration (FDA) to require drug manufacturers to conduct tests on children to determine if new drugs will be safe and effective for pediatric use was struck down by a federal court October 17. In a challenge to the "pediatric rule" by the Association of American Physicians and Surgeons, Inc., the U.S. District Court for the District of Columbia said Congress didn’t authorize the FDA to set a pediatric requirement when it passed the Food, Drug and Cosmetic Act years ago.
The court pointed out that because of the difficulty in finding substantial pediatric populations to undergo tests, along with the ethical complications associated with testing new drugs on children, many drugs are tested for safety and effectiveness in adults only. "As a result, even though there are many diseases that are common to both children and adults, physicians with pediatric patients often find their treatment options limited," with doctors forced to choose between prescribing drugs without well-founded dosage and safety information or utilizing other, possibly less effective, therapy. Most often, doctors respond by prescribing adult-approved drugs to children, but in smaller doses.
In an effort to encourage pediatric testing, Congress in 1997 passed the Food and Drug Administration Modernization Act (FDAMA), which established an experimental program giving manufacturers an extra five years of market exclusivity on drugs that they agreed to test in children.
But the incentive for voluntary tests didn’t increase pediatric testing as much as the FDA had hoped, so in 1998 the agency issued a rule requiring manufacturers to submit pediatric tests for new products that are likely to be used by children, beginning in December 2000. The regulation would also allow the FDA to require tests of already marketed drugs that it suspects are risky for children.
With that "pediatric rule" now barred by the federal district court, it’s unclear what will happen next in pediatric drug testing. The FDA could take its case to appeals courts and possibly even to the Supreme Court, or Congress could amend the Food, Drug and Cosmetic Act to give the FDA specific authority to require pediatric testing. Meanwhile, the incentive for voluntary pediatric testing by drug companies in return for market protection remains in place under the Best Pharmaceuticals for Children Act, Public Law 107-119, passed by Congress earlier this year.
The case decided October 16 was Association of American Physicians
and Surgeons, Inc., v. United States Food and Drug Administration.
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Does CHIP Make a Difference to Children with Access to a Safety Net?
In Denver, Colorado, Denver Health (DH), one of three major health care providers in the city, operates 13 school-based health centers, 10 family health centers located in medically underserved neighborhoods, and pediatric urgent care facilities. DH and the two other health maintenance organizations enroll low-income Denver children through a variety of public programs. Given this well-developed safety net, researchers wondered if the enactment of the Children’s Health Insurance Program and enrollment of previously uninsured children in CHIP have made much difference in Denver children’s use of health care.
Congress enacted CHIP (the program is often referred to as SCHIP, for State Children’s Health Insurance Program) in 1997, the researchers point out, because of a continued gap in health insurance coverage for children. Despite considerable expansion of Medicaid coverage in the 1980s, approximately 12 percent of all children younger than 17 years in the United States, and 21 percent of families with incomes below 200 percent of poverty, lacked health insurance in 1997.
Since CHIP was enacted, there have been a number of studies of the difficulties encountered in enrolling eligible children, but so far there has been little scrutiny of CHIP’s effect on access to health services, use of services, and quality of care. "Even enrollment into an insurance program does not necessarily guarantee access to needed health care," say researchers Sheri Eisert and Patricia Gabow of the Denver Health Medical Center. "Once the CHIP-eligible population has been identified and enrolled, access to services must follow for CHIP to have a positive impact on the health status of children."
To determine if there were differences in health care utilization between children who were enrolled in CHIP and uninsured children--and also whether children who enrolled in CHIP received more health care than they had received before enrollment--the researchers looked specifically at Denver Health, which during the study period enrolled more than half of Denver County’s CHIP children. They merged CHIP enrollment data from 1998 to 2000 with Denver Health utilization data in the same period, looking at such outcomes as emergency care, urgent care, specialty care, well-child care, dental visits, and immunizations.
Their conclusions:
"It is noteworthy," the researchers said, "that approximately 64 percent of the enrolled children actually used services. Because at the time of the study, Colorado’s CHIP program required monthly premium payments, there were concerns that only the sickest children would enroll. Clearly, a considerable number of parents were willing to pay the premium truly to provide ‘insurance’ in case their children needed health care."
As to one of the other concerns about CHIP, both locally and nationally--that families would drop commercial insurance for the less expensive CHIP option--the research found that only 6 percent of the children had private insurance in the year before enrolling in CHIP. Eighteen percent of the CHIP-enrolled children had been on Medicaid, and 37 percent had been on the state’s indigent care program in the year before enrollment, demonstrating, the researchers indicated, "the flux of family incomes around the relatively narrow band between 185 percent and 200 percent of the federal poverty level."
Their findings that CHIP enrollment increased utilization of health care were especially impressive in light of Denver’s relatively well-developed health care safety net system, the researchers noted. "One might anticipate that the impact on access would be even greater in communities that do not have as well-developed a safety net system."
The research report, "Effect of Child Health Insurance Plan Enrollment
on the Utilization of Health Care Services by Children Using a Public
Safety Net System," appeared in the November 2002 issue of the journal
Pediatrics. Reprints are available from gheri.eisert@dhha.org.
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How HMOs Handle Hepatitis B Vaccination
A study that followed adolescents who were continuously enrolled in health maintenance organizations (HMOs) for five years, when they were 11 to 15 years old, found that some practices were more successful than others in encouraging initiation and completion of hepatitis B immunizations in the 11-15 age group.
Because young people have the highest incidence of HBV infection in the United States, the Advisory Committee on Immunization Practices in 1995 recommended routine Hep B vaccination of all previously unvaccinated 11- to 15-year-old adolescents. But we know very little about how well those recommendations are carried out by HMOs, say researchers who looked at data from three major health maintenance groups—Kaiser Permanente in California and Oregon, and the Group Health Cooperative of Puget Sound in Seattle, Washington.
There were some potential barriers to vaccinating adolescents, the report concedes, including the fact that complete immunization at the time of the study called for three doses of vaccine, at intervals ranging from one to several months. In all three of the HMOs, the researchers found much higher rates of first-dose administration than for the second and third shots. They noted that this happened despite the fact that all the young persons studied had a "medical home" for the entire period of the study, which was expected to produce higher immunization rates by assuring continuity of care and reducing record scattering.
While the hepatitis B vaccination rate increased over the years of the study in all the HMOs, it never reached the goal of 90 percent immunization that been set by the federal government. In the HMO with the highest coverage, fewer than 70 percent of young persons were fully immunized, even though routine vaccinations were a completely covered benefit for the adolescent population studied.
The HMO that was most successful in achieving full immunization used an electronic immunization registry that reminded providers on a monthly basis which patients were overdue for immunizations. It also printed reminder letters, thus serving as both a provider and a client reminder/recall system. In addition, the HMO sent letters to all clients who were turning 11 years of age, reminding them to schedule an appointment for vaccination and a physical examination.
In contrast, one of the other HMOs implemented a one-time provider and recall notice for patients ages 11 to 15, printing two copies of the patient’s history and needed vaccines, one for the provider and one for the patient. This HMO also sent annual letters to patients who were turning 11, reminding them of vaccinations and the need for a physical examination. A third HMO had no such strategies in place during the period of the study, though it later inaugurated an electronic weekly immunization list for providers, identifying 12-year-old clients who are overdue for vaccinations.
The researchers had some recommendations for improving hepatitis B immunization coverage.
For one thing, they said, it’s crucial to simplify the vaccination schedule, including switching to a two-dose regimen rather than the three-dose strategy that was in place at the time of the study. "Given our findings of a marked drop-off rate between the first and third doses of HB vaccine, one strategy likely to result in more complete protection of adolescents is the use of the two-dose HB vaccination schedule approved in 1999 for adolescents 11 to 15 years of age," they said. The researchers note that recent studies have shown the two-dose schedule is as immunogenic as the three-dose series, and they say rates of full immunization would have been much higher in their study if adolescents had needed only two doses to complete their HB coverage. Also, school-based vaccination programs have been shown to be highly successful in achieving high HB vaccination coverage rates among adolescents, and a two-dose schedule may be easier to implement during the academic school year.
But even if providers are not sure that adolescents will return for the second and third doses, that should not discourage starting the series, the researchers maintain, because high seroconversion rates have been reported after just one dose.
Another strategy to improve coverage rates among adolescents, the report suggests, would be to allow longer intervals between doses. Since both the American Medical Association and the American Academy of Pediatrics recommend routine annual preventive visits for adolescents, administering vaccine at yearly intervals, in combination with a two-dose strategy, would allow for complete protection to be achieved within a 12-month period.
And third, the researchers point out, middle school-entry vaccination mandates have proved to be an effective way to improve routine adolescent immunizations. "As more and more states implement and enforce these laws, it is likely that school requirements will contribute substantially toward attainment of the Healthy People 2010 goal of 90 percent HB vaccination coverage among adolescents."
The research report, "Hepatitis B Vaccination Among Adolescents
in 3 Large Health Maintenance Organizations," appeared in the November
2002 issue of the journal Pediatrics. Reprints are available from mmassoudi@
cdc.gov. (The researchers point out that their study concluded in
1999 and they urge further assessment of hepatitis B immunization procedures
that have been adopted by HMOs since that time.)
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Update on HIPAA Medical Privacy Regulations
Critics Charge Regs Will Hamper Research
An article in the October 20 issue of The New England Journal of Medicine raises the possibility that final rules published in August 2002 for the medical privacy sections of the Health Insurance Portability and Accountability Act (HIPAA) will have a chilling effect on biomedical, epidemiologic, and health-sciences research.
Attorney Jennifer Kulynch, a member of a Washington, D.C., law firm, and Dr. David Korn of the Association of American Medical Colleges questioned whether strict "de-identification" requirements in the regulations—which require that individual medical records to be stripped of such "unique identifiers" as zip codes and birth and hospital discharge dates before being provided to researchers--may result in the records being useless for many research purposes. The 2002 rule does allow providers and hospitals to use or share a "limited data set" that is stripped of fewer identifiers, but only if the researcher agrees to numerous data-use restrictions.
The authors note that medical research is already regulated under the federal "common rule," which governs all research approved by institutional review boards. "We question whether, on balance, the public gains more than it loses when research is further encumbered by these additional regulations," they said.
The writers note that the Department of Health and Human Services has estimated the cost of implementing the research-waiver provisions will be will be nearly $450 million over a 10-year period, but they say it is difficult to estimate the additional cost of "research impeded or foregone." Given the burden of compliance, it seems almost sure that the pace and volume of research will diminish, they say.
"Since the rule has rigid authorization and accounting requirements, community providers—whether individual physicians, clinics, or hospitals—may decide to withhold data from researchers in order to avoid the expense of compliance, along with possible investigations by the Department of Health and Human Services triggered by complaints from patients or employees," the researchers concluded.
Source: "Perspective: The New Medical-Privacy Rule," The New England Journal of Medicine, October 10, 2002.
Consumer Group Sees ‘Privacy Peepholes’
In another take on the HIPAA privacy regulations, the Institute for Health Freedom, a consumer advocacy group, charges that by making it unnecessary for health care providers to obtain an individual’s consent to use or disclose identifiable protected health information, the August 2002 rules weaken patient privacy rights.
Citing specific sections of the regulations, the Institute points out that the final rules allow disclosure of an individual’s medical records to doctors, hospitals, and payment groups that need the information to treat or bill patients, and also to law enforcement agencies, researchers (if an institutional review board waives consent), public health authorities, the federal Food and Drug Administration, and judicial and administrative agencies.
A consent requirement was originally part of the HIPAA privacy regulations, but was eliminated when the final regs were published in August. Instead, HIPAA "covered entities" must now post their privacy policies and try to make sure that patients understand them.
The Institute notes that legislation introduced in Congress would close the "privacy peepholes" by restoring the consent requirement, strengthening prohibitions on using private medical information for marketing purposes, and narrowing the purposes for which personal medical information can be disclosed to FDA-regulated entities such as drug companies.
Source: The Institute for Health Freedom, www.ForHealthFreedom.org.
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In Congress
New Law Continues Federal Support for Health Centers
In October, President Bush signed a bill reauthorizing for five more years a federal program that provides support to community health centers.
Public Law 107-251, the Health Care Safety Net Amendments of 2002, was hailed by U.S. Health and Human Services Secretary Tommy Thompson as "opening the door to new opportunities to improve the way underserved populations receive needed health services."
"It couldn’t be happening at a more critical time," Thompson added. "This action follows the recent release of new data showing that the number of uninsured Americans rose by 1.4 million, to 41.2 million people."
The safety net legislation, considered a priority by the Bush administration, was passed by the Senate in April and by the House in October and was agreed to by a House/Senate conference shortly after House passage. In addition to reauthorizing the existing community health centers program, the bill
During the conference following House passage of the bill, the Senate agreed to drop a provision in its version of the legislation that would have authorized federal funding for school-based health centers networks. Funds could have been used to establish state technical assistance centers to coordinate federal, state, and local health care services, including primary, dental, behavioral and mental health, that contribute to the delivery of school-based health care. Funds could also have been used to provide technical support and training to school-based health centers.
John Schlitt, executive director of National Assembly on School-Based Health Care, expressed disappointment that the House had refused to accept the school-based health centers provision of the bill, but he noted that "This was our first organized effort to advance SBHC policy and we should take comfort in how far it progressed."
The House and Senate are currently meeting in pro forma sessions, meaning
no business is being conducted, and the 107th Congress expected
to adjourn for good after the elections. A Department of Health and
Human Services appropriations bill for fiscal year 2003, which began
October 1, has not been passed, and federal programs are being funded
under a "continuing resolution" that generally provides the same level
of support that the programs, including community health centers, received
in fiscal 2002.
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Worth Noting
CDC Notes 25th Anniversary of Smallpox Eradication
The Centers for Disease Control and Prevention called attention in
the October 25 issue of Morbidity and Mortality Weekly Report
to the fact that the last case of naturally acquired smallpox in the
world occurred in Somalia in 1977. Shortly thereafter, in May 1980,
the World Health Organization certified the world free of naturally
occurring smallpox. Even before 1977, the risk for importation of the
disease to the United States was considered so slight that routine smallpox
vaccinations were discontinued for the general population in 1971 and
for health care workers in 1976. The CDC’s commemoration of the 25th
anniversary of eradication came as the public health system is considering
how to protect the U.S. population if terrorists were to use the smallpox
(variola) virus as a bioterrorism agent. At the time of this publication,
a final U.S. policy on smallpox vaccination was pending. Additional
information on smallpox is available at www.bt.cdc.gov/agent/smallpox/index.asp.
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Smallpox Virus Can Be Transmitted from Vaccinated Persons
Because smallpox virus is shed from a vaccination site for as much
as 19 days after the vaccination, unimmunized persons who are in close
contact with a vaccinated individual sometimes develop "contact vaccinia,"
according to an article published in the October 16 issue of the Journal
of the American Medical Association. At particular risk of such
transmission are persons with compromised immune systems as the result
of AIDS or chemotherapy, and persons with active or chronic skin conditions
such as eczema. Risk of such contact infection was slight in the past,
when most of the population was immunized, but it is not known how many
incidents might occur if widespread vaccination were instituted in the
United States at this time, when most people have never been vaccinated
or were vaccinated so long ago that they are no longer immune, smallpox
researchers said.
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New Rule Would Expedite Generic Versions of Drugs
A loophole in Food and Drug Administration regulations that has allowed
drug manufacturers to block introduction of generic versions of their
products for many years after their patents expire would be closed under
new regs being proposed by the U.S. Department of Health and Human Services.
The proposed change would end the option currently available to brand-name
drug manufacturers of requesting repeated delays in the marketing of
generic alternatives. The proposed regs would save consumers approximately
$3.5 billion every year because generics are lower in price than their
brand-name equivalents, said HHS Secretary Tommy Thompson. The proposed
regulation appeared in the Federal Register October 24.
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Parents Misunderstand Hepatitis A
The American Liver Foundation said October 29 that a national survey
shows most parents don’t know that hepatitis A, an infectious liver
disease contracted through fecal/oral contamination, is one of the diseases
that children can and should be vaccinated against. Hepatitis A vaccine
is available for children over two years of age, but parents may not
know to ask their doctors about it, the foundation says. Of the various
types of hepatitis, both B and C are better known and understood, though
A can cause severe liver illness and is occasionally fatal. The American
Liver Foundation can be contacted at www.liverfoundation.org.
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The following information appeared during the month of October in the News Alerts section of this website.
ANA, HHS to Create National Nurse Response Teams
The federal Department of Health and Human Services has signed a memorandum of understanding with the American Nurses Association (ANA) creating National Nurse Response Teams as a component of the National Disaster Medical System. To date, said HHS Secretary Tommy Thompson, more than 900 nurses have volunteered for the new teams, which would be tasked with providing patient education and counseling, administering immunizations, and other activities in the event of a national emergency. "The ANA is extremely pleased to be partnering with HHS in this endeavor," said American Nurses Association president Barbara Blakeney. The memorandum of understanding calls for establishing a nursing team in each of the HHS regional locations—Boston, New York, Philadelphia, Atlanta, Dallas, Chicago, Kansas City, Denver, San Francisco, and Seattle. HHS is offering the teams support in development and organization, administrative management, training, and program development and delivery.
Congressman Emphasizes Early Intervention to Prevent Special Ed
Among changes in the Individuals with Disabilities Act being considered by House and Senate committees in charge of reauthorizing the special ed law is a proposal offered by Senator Patrick Kennedy (D-RI) that would make grants to state and local education agencies to develop and implement strategies to reduce the number of children who have, or are at risk of developing, emotional disturbances. In a bill introduced last month, Kennedy, whose state has the highest special education rate in the nation, pointed out that approximately 473,000 students between the ages of 6 and 21 who received special education in 2000-2001 were identified as having emotional disturbance, representing 7.7 percent of children with disabilities. He also noted that children who show symptoms of mental health conditions are often not identified and do not receive needed services. "Improving outcomes for children with emotional disturbances depends not only on improving the learning opportunities of such children but also on promoting effective coordination among schools, families, and systems that provide services for such children, such as the social services, health, mental health, child welfare, and juvenile justice systems," Kennedy pointed out.
HHS Makes Grants for Dental Care, Early Identification of Development Delays
The District of Columbia will receive $450,000 to create two state-of-the-art dental clinics at schools serving children with special health care needs, under a Department of Health and Human Services program to encourage innovative state approaches to improve health care and social services. The centers will use telemedicine to link patients with pediatric dentists and hygienists and will conduct outreach, education, and home-based monitoring for parents and caregivers of children with special health care needs who have dental problems. Another grant of $500,000 will go to Boulder and Denver counties in Colorado to promote screening of young children in early childhood centers for developmental delays and behavior issues. The two grants are part of $2.5 million in state innovation awards announced by HHS October 3.
Adolescent Overweight Still on the Rise, JAMA Reports
Adolescent overweight is continuing to increase, particularly among Mexican-American and non-Hispanic black adolescents, according to a study published in the October 9 issue of the Journal of the American Medical Association. An analysis of data for the years 1999-2000 showed 15.5 percent of 12- to 19-year-olds are overweight (defined as at or above the 95th percentile of the sex-specific body mass index (BMI) for age growth charts), an increase of 5 percent since 1994 for the youth population overall and an increase of more than 10 percentage points for Mexican-American and non-black Hispanic adolescents. The study, "Prevalence and Trends in Overweight Among U.S. Children and Adolescents, 1999-2000," appears in the October 9 issue of the Journal of the American Medical Association.
Study Reports on Brain Characteristics of ADHD Children
A 10-year study of 152 children and adolescents identified as having attention deficit hyperactivity disorder (ADHD) and 139 age- and sex-matched controls recruited from the community found that the brains of the ADHD children and youths were significantly smaller in all regions—total cerebrum, cerebellum, gray and white matter for the four major lobes, and caudate nucleus--than the brains of unaffected peers. The researchers concluded, however, that the differences were present before the ADHD children were placed on stimulant medication and did not appear to have been caused by the medication. They also found that the brains of the ADHD children continued to develop, along the same trajectories as those of their unaffected peers, through childhood and youth, but at a slightly lower track. "Fundamental developmental processes active during late childhood and early adolescence are essentially healthy in ADHD," said principal researchers Drs. Xavier Castellanos and Judith Rapaport of the National Institute of Mental Health’s Child Psychiatry Branch. "Symptoms seem to reflect fixed earlier neurobiological insults or abnormalities," including the possibility that ADHD may have genetic roots. The research report, "Developmental Trajectories of Brain Volume Abnormalities in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder," appears in the October 9, 2002, issue of the Journal of the American Medical Association.
JAMA Seeks Papers on Obesity Research
Asking why, during a time when the amount of research activity, knowledge, and interest in obesity among the medical community, as well as the level of public attention to the issues of weight, diet, and exercise have never been greater, the epidemic of obesity continues virtually unabated with no sign of reversal, the Journal of the American Medical Association is joining its related publication, Archives of Pediatrics and Adolescent Medicine, in devoting an entire issue to obesity research in spring 2003. Reports of clinical trials that evaluate the effectiveness of interventions; reports that better characterize the relationship between health and weight reduction, nutrition, and physical activity; and papers that provide insights about the underlying pathopsychology of obesity are welcome. Authors should consult the JAMA guidelines on manuscript preparation and submit papers by December 31, 2002.A call for papers appeared in the October 9 issue of the Journal of the American Medical Association.
CDC Reminds Schools of No-Smoking Law
Schools from kindergarten through high school have been reminded by the Centers for Disease Control and Prevention that a provision of the No Child Left Behind Act (P.L. 107-110) forbids indoor smoking in any indoor space that’s utilized to provide educational services, routine health care, or library services to children under the age of 18. The ban on smoking also applies to day care or early childhood development facilities. This is a continuation of a smoking ban that has been in effect since 1994 and applies to facilities that are funded by the federal government or by state or local governments that receive federal funds, such as school districts. The reminder appeared in the Federal Register October 10.
AAP Will Look for MMR/Autism Link
To try to learn if the recommended childhood vaccination for measles, mumps, and rubella causes autism in some children, the Centers for Disease Control and Prevention has made a one-year, $450,000 grant to the American Academy of Pediatrics (AAP) to determine if measles vaccine strain gene sequences are present in the intestinal tissues of children with autism spectrum disorder and in the intestines of non-autistic control children. The CDC noted that the potential role of the MMR vaccine as a cause of autism "has divided segments of the medical, scientific and public communities and threatens to adversely effect the MMR immunization program in the United States as it has in the United Kingdom and Ireland, where the MMR immunization rates have dropped sharply from above 95 percent to just over 70 percent" as the result of two published papers alleging a connection. The AAP research is expected to involve organizations in the U.S. that feel strongly there either is or is not a link between MMR and autism, as well as major universities and medical groups in this country and Ireland. Announcement of the grant appeared in the Federal Register October 11.
Medicare/ Medicaid Office Will Enforce HIPAA Transactions Rules
The U.S. Department of Health and Human Services announced in October that the Centers for Medicare and Medicaid Services (CMS) in HHS will be responsible for enforcing transaction and code set standards under the Health Insurance Portability and Accountability Act (HIPAA). A new office to be created in CMS will create and operate enforcement procedures related to the HIPAA standards, which include code sets and identifiers for providers, insurers, and employers to use in electronic transactions. With the exception of certain small health care plans, all health plans, clearinghouses, and those providers that conduct certain transactions electronically must be compliant with the HIPAA transactions standards as of October 16, 2002, unless they have applied for an extension. CMS says enforcement of the HIPAA transactions requirements will focus on voluntary compliance and technical assistance. "The process will be primarily complaint driven and will consist of progressive steps that will provide opportunities to demonstrate compliance or submit a corrective action plan." A fact sheet summarizing the standards required by HIPAA is available at www.hhs.gov/news/press/2002pres/hipaa.html. Enforcement of the HIPAA privacy regulations published August 14 this year will continue to be the responsibility of the Office for Civil Rights in HHS.
Health Funding Available for Community Organizations
Johnson & Johnson Community Health Care Program, in cooperation with Johns Hopkins Bloomberg School of Public Health and the National Council of La Raza, has announced the availability of 2003 funds to assist community health care organizations to improve access to quality health care to under-served populations, with special emphasis on quality of care for women and children, including adolescents. Deadline for applications is November 30, 2002. Information is available at www.jhsph.edu/johnsonandjohnson. Since 1987, Johnson & Johnson has made $9.5 million in community health care grants to 103 organizations in 30 states and Puerto Rico.
Report Cites Crisis in Mental Health
The National Council on Disability, in a report released in September, charged the U.S. mental health system is unable to provide basic services and supports to people with psychiatric disabilities. The report concluded that children in the public mental health system are underserved and will have greater dependency later in life. The report, "The Well-Being of Our Nation: An Inter-Generational Vision of Effective Mental Health Services and Supports," is available at www.ncd.gov/newsroom/publications/mentalhealth.html.
NIH Launches Nationwide Research to Reduce Asthma in Inner-city Children
The National Institute of Allergy and Infectious Diseases in the National
Institutes of Health has awarded a six-year $55.8 million contract to
the University of Wisconsin at Madison to establish a nationwide research
network with the goal of reducing the severity of asthma and preventing
the disease in inner-city children, a group that suffers disproportionately
from asthma. The Inner-City Asthma Consortium will conduct clinical
trials to evaluate the effectiveness of immune-based and other asthma
treatments as well as possible genetic predispositions to asthma and
biological mechanisms underlying the disease. Participating institutions
include Boston University, Boston, Massachusetts; Children’s Memorial
Hospital, Chicago, Illinois; Howard University, Washington, D.C.; Johns
Hopkins University, Baltimore, Maryland; Mt. Sinai Medical Center, New
York City; National Jewish Medical Center, Denver, Colorado; University
of Arizona, Tucson; and the University of Texas Southwestern Medical
Center in Dallas.
Stronger Federal Oversight Urged for Medicaid, SCHIP
In a report released October 30, the Institute of Medicine in the National Academies of Science urged the federal government to play a stronger role in assuring that there are minimum standards of care and fully computerized clinical records in six government programs that together provide health care to one-third of all Americans—Medicare, Medicaid, the State Children’s Health Insurance Program (SCHIP), Department of Defense TRICARE programs, the Veterans Health Administration, and the Indian Health Service. Government agencies including the Department of Health and Human Services were told to coordinate efforts to improve the safety and quality of treatment for the 100 million beneficiaries of the federal programs. The full text of the report, "Leadership by Example: Coordinating Government Roles in Improving Health Care Quality," is available on the Internet at http://search.nap.edu/books/0309086163/html