JAMA news releases are made available to the public after 3 pm US Central time on the first 4 Tuesdays of each month. The Archives Journals news releases are made available to the public after 3 pm Central time on Mondays. We also provide a list of previous news releases.
THIS WEEK'S CONTENT
JAMA NEWS RELEASES (Health of the Nation Theme Issue)
(Embargoed for Release: 10:00 a.m. ET, Tuesday, October 21, 2008)
JAMA NEWS RELEASES
STUDY DOCUMENTS SAFETY PROBLEMS FOR BIOLOGICAL PRODUCTS
HIGH NUMBER OF CHILDREN AND TEENS IN U.S. UNINSURED DESPITE HAVING A PARENT WITH HEALTH INSURANCE
COMPREHENSIVE TAX REFORM COULD PLAY IMPORTANT ROLE IN CREATING HEALTH CARE REFORM
COLLABORATION BETWEEN STATES, FEDERAL GOVERNMENT KEY TO HEALTH CARE REFORM
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
RESEARCHERS STUDY U.S. FAMILIES IN WHICH AT LEAST ONE PARENT HAS HEALTH INSURANCE BUT THEIR CHILDREN DO NOT HAVE COVERAGE
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
TV Note: This week's JAMA Report video is on the number of children who are uninsured despite having a parent with health insurance. The report will be fed Tuesday, October 21, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 28 (C-Band), Transponder 19, downlink frequency: 4080 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.
Save the Date: JAMA will present new research from its theme issue, "Health of the Nation", at a media briefing on Tuesday, October 21, from 10 a.m. – 12:15 p.m., at the National Press Club in Washington, D.C. To register, go to www.jamamedia.org and click on the Events tab, or call 312-464-JAMA. Program information will be included in a future email.
Please Note: Because JAMA does not publish on the 5th Wednesday of a month, there will be no JAMA or news releases for October 29.
Please Note: The FOR THE MEDIA Web site now has a search feature to enable media to find previous JAMA/Archives news releases on specific medical topics. This search feature link is located on the home page at www.jamamedia.org.
JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ONLINE
Go to www.jamamedia.org for more information and to apply for access.
Embargoed for Release: 10:00 a.m. ET, Tuesday, October 21, 2008
Media Advisory: To contact corresponding author Aukje K. Mantel-Teeuwisse, Ph.D., email: a.k.mantel{at}uu.nl. To contact editorial co-author Catherine D. DeAngelis, M.D., M.P.H., call Jann Ingmire at 312-464-2499.
STUDY DOCUMENTS SAFETY PROBLEMS FOR BIOLOGICAL PRODUCTS
WASHINGTON, D.C.—Approximately one in four biological medicinal products (such as antibodies, enzymes and insulin) approved since 1995 in the U.S. and Europe have had at least one safety-related regulatory action issued for them 10 years after their approval, including about 11 percent receiving a “black box” warning, according to a study in the October 22/29 issue of JAMA, a theme issue on the Health of the Nation.
Biologicals are preparations in which the active substance is produced by or extracted from a biological source, such as antibodies, enzymes and hormones. They represent an important and growing part of medical therapies, with more than 250 biologicals having been approved since 1982, according to background information in the article. “Between 2003 and 2006, biologicals represented 24 percent and 22 percent of all new chemical entities approved by the U.S. and EU [European Union] regulatory authorities, respectively,” the authors write. “Biologicals are a relatively new class of medicines that carry specific risks (e.g., immunogenicity [the ability to stimulate an immune response]). However, limited information is available on the nature and timing of safety problems with their use that were identified after approval.”
Thijs J. Giezen, Pharm.D., of Utrecht University, Utrecht, the Netherlands, and colleagues examined the nature and probability of safety-related regulatory actions issued for biologicals approved in the United States and/or the European Union between January 1995 and June 2007. Vaccines, allergenic products (a substance capable of causing an allergic reaction), and products for further manufacture and transfusion purposes were excluded.
A total of 174 biological medicinal products obtained approval during the study period, including 136 biologicals approved in the U.S. and 105 in the European Union, of which 67 biologicals obtained approval in both regions during this time. The researchers found that between January 1995 and June 2008, 82 safety-related regulatory actions were issued for 41 of the 174 biologicals (23.6 percent). These included 46 written communications (warnings of health hazards) to health care professionals in the U.S., 17 in the European Union, and 19 black box warnings (warning of serious health hazards). No biologicals were withdrawn due to safety reasons.
The average time to a safety-related regulatory action was 3.7 years and 70.7 percent of the safety-related regulatory actions were issued within five years after approval. The probability of a biological requiring its first safety-related regulatory action was 14 percent three years after approval and 29 percent ten years after approval. Biologicals that were the first to be approved in their chemical, pharmacological, and therapeutic subgroup had a significantly higher risk for the occurrence of its first safety-related regulatory action compared with later approved products.
The safety-related regulatory actions issued for biologicals mostly involved the system organ classes of general disorders and administration site conditions (26.8 percent of 82), infections and infestations (22 percent), immune system disorders (15.9 percent), and neoplasms benign, malignant, and unspecified (12.2 percent). “The safety-related regulatory actions issued in the system organ class of general disorders and administration site conditions can be partly explained by the infusion reactions occurring after the parenteral [intravenously or by injection] route of administration, which is the mode of administration for most biologicals. A more in-depth evaluation of the mode of action of biologicals might have predicted some safety problems during the developmental phase.”
“Although the limitations of preclinical trials for biologicals are acknowledged, results from pharmacology studies, preclinical studies, and clinical studies might result in the prediction of potential risks related to the drug for which close monitoring is needed in the postapproval setting. Health care professionals should be aware of the specific risks related to the relatively new class of biologicals to be able to provide a link between the use of the biological and the patient presenting with a clinical problem,” the authors write.
(JAMA. 2008;300[16]:1887-1896. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
EDITORIAL: PRESCRIPTION DRUGS, PRODUCTS LIABILITY, AND PREEMPTION OF TORT LITIGATION
In an accompanying editorial, Catherine D. DeAngelis, M.D., M.P.H., Editor-in-Chief, JAMA, and Phil B. Fontanarosa, M.D., M.B.A., Executive Deputy Editor, JAMA, Chicago, write that these findings show the need for improvement in the drug approval process and the postmarketing surveillance system.
“As shown in the study by Giezen et al, many safety problems are identified only after drug approval. The human body is in a constant state of change and the effects of some drugs will manifest only after exposure over time. Furthermore, some serious adverse drug effects are quite uncommon and require use of the drug in large numbers of patients to become evident. The safety of drugs in a clinical trial, the study type used for Food and Drug Administration approval, is based on specific participant types, numbers, and design that cannot ensure the true safety of a drug. In addition, manipulation of study results by the drug manufacturers (who almost always sponsor studies used for decisions about drug approval) can obscure the true safety profile of a drug.”
“Given the current imperfect process for approval and the flawed postmarketing surveillance system, the drug and device regulation process is at best an inexact and incomplete science. Until these deficiencies in the system are remedied, some patients inevitably will continue to experience harm from the use of newly marketed products as well as from use of other approved medications. Just as with other consumer products that cause harms, consumers (i.e., patients) who are injured by defective medical devices or by pharmaceutical products with inadequate warnings of potential harms may have to resort to legal action as recourse for their injuries.”
(JAMA. 2008;300[16]:1939-1941. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 10:00 a.m. ET, Tuesday, October 21, 2008
Media Advisory: To contact Jennifer E. DeVoe, M.D., D.Phil., call Christine Decker at 503-494-8231.
HIGH NUMBER OF CHILDREN AND TEENS IN U.S. UNINSURED DESPITE HAVING A PARENT WITH HEALTH INSURANCE
WASHINGTON, D.C.—Approximately 4 percent of U.S. children and adolescents have a gap in health insurance coverage at some point during the year, even though they have at least one parent who is insured, according to a study in the October 22/29 issue of JAMA, a theme issue on the Health of the Nation.
Jennifer E. DeVoe, M.D., D.Phil., of Oregon Health & Science University, Portland, presented the findings of the study at a JAMA media briefing at the National Press Club in Washington, D.C.
More than 9 million children in the United States have no health insurance coverage. When including those with a coverage gap at some point during the year, that number doubles. “Stable health insurance coverage allows for consistent access to health care services, which contributes to better health outcomes. Discontinuities in children’s health insurance coverage, even for only a few months, are associated with significant unmet health care needs,” the authors write. Efforts to expand insurance for children often focus on extending public coverage to uninsured parents. Little is known about the characteristics of families with uninsured children and at least one insured parent.
Dr. DeVoe and colleagues examined the demographic and socioeconomic characteristics of children and adolescents younger than 19 years of age who were more likely to be in families with parent-only health insurance coverage. The researchers conducted an analysis of pooled 2002-2005 data from the nationally representative Medical Expenditure Panel Survey (MEPS).
The researchers found that in the cross-sectional study population, 1,380 (3.3 percent) of 39,588 children and adolescents were uninsured with at least 1 insured parent. Among just the uninsured children, 27.9 percent had an insured parent. Characteristics that were associated with a higher likelihood of a child or adolescent being uninsured despite having a parent with health insurance included: low- and middle-income households, low parental educational attainment (less than a high school education), Hispanic ethnicity, single-parent households, geographic residence in the South or West and having a parent with private insurance coverage.
“When weighted, these estimates represent 3 million children who had a coverage gap despite having at least 1 parent who had full-year coverage. More than a million of these children were without coverage for the entire year,” the researchers write.
“If families are better off covered under 1 plan but U.S. society rejects a public health insurance program for all members of the family, the question of whether the employer-based model is sustainable may need to be revisited. In this study, the private system did not do a good job of providing coverage for entire families.”
“Incremental expansions in public insurance programs for children will continue to improve insurance rates in the short term. However, the longer-term solutions to keeping all children insured are likely to be more complicated. Unless health insurance coverage models are designed to keep entire families covered, some children will continue to get left behind. It is time to think beyond health insurance models to achieve a sustainable health care system and the best possible health outcomes for all families,” the authors conclude.
(JAMA. 2008;300[16]:1904-1913. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 10:00 a.m. ET, Tuesday, October 21, 2008
Media Advisory: To contact Samuel Y. Sessions, M.D., J.D., call Laura Mecoy at 310-546-5860.
COMPREHENSIVE TAX REFORM COULD PLAY IMPORTANT ROLE IN CREATING HEALTH CARE REFORM
WASHINGTON, D.C.—A proposal to implement a value-added tax for universal health insurance vouchers would also provide for significant decreases in other taxes, according to the authors of a commentary in the October 22/29 issue of JAMA, a theme issue on the Health of the Nation. They add that this plan would create incentives for cost-containment and health care quality.
Samuel Y. Sessions, M.D., J.D., of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, Calif., presented the commentary at a JAMA media briefing at the National Press Club in Washington, D.C.
Dr. Sessions and co-author Philip R. Lee, M.D., of the University of California, San Francisco, write that the complex variety of health care funding sources has left U.S. health care finance in disarray. “It is time to consider a thorough overhaul of this non-system. The goal would be not only to strengthen health care finance for its own sake, but also to achieve fundamental reform of health care. In other words, along with a small but increasing number of other commentators, we contend that comprehensive tax reform could be a powerful driver of health care reform.”
According to the authors, comprehensive tax reform would mean re-examining and re-engineering the entire structure of the U.S. tax system. “The 60 percent of U.S. health care costs financed by taxes equals 10 percent of U.S. gross national product or more than one-third of federal and state tax revenues. That is, de facto U.S. tax and health policy already devotes more than one-third of all U.S. taxes to health care.” They suggest that tax and financing reform would result in increased accountability of government policy makers for health care finance decisions and greater public awareness of health care costs; a system structured so that nearly everyone pays into and benefits from the same program, and incentives for all to consider both costs and benefits.
The authors propose, building on the work of Ezekiel J. Emanuel, M.D., Ph.D., and Victor R. Fuchs, Ph.D., a value-added tax (VAT) to finance a system of universal health insurance vouchers. “Insurers would be required to accept any applicant presenting a voucher regardless of health status. Risk adjustment, possibly with a backup reinsurance pool, would protect them against adverse selection. Households could purchase additional insurance, but with after-tax dollars only; the subsidy for employer-provided insurance would be repealed. Medicaid would be phased out under a set schedule. Medicare would also be phased out by not adding new enrollees and by allowing Medicare beneficiaries already enrolled to opt into the new system if they wanted to do so.”
They write that a rough estimate at current health care cost levels would be for a VAT rate of as low as 5 percent if most existing revenues are retained and of more than 20 percent if the VAT were used as the sole revenue source. The VAT and perhaps other revenues would be dedicated to the voucher system. Tax increases from the VAT would be offset by significant, and potentially dramatic, cuts in other taxes. Substituting VAT revenues for income taxes now used to pay for health care would make it possible both to remove many U.S. households from the income tax entirely and to institute significantly lower tax rates for the remainder. Also, many incomes would increase by the amount of premiums no longer paid by employers or employees.
“Because families and individuals would be able to choose freely among health care insurers, insurers would have to compete to secure and retain their customer base. This would weaken incentives to focus on cost-shifting gamesmanship and strengthen incentives to pursue customer satisfaction and long-term and short-term health care quality. It would also require establishing working relationships motivated by the same goals with individuals and institutions directly providing health care.”
“For better or worse, fundamental tax and finance issues are inevitably much more than extra cargo in health care policy. Unfortunately, and in no small part because of skittishness about directly confronting the subject of taxes, they have too often been treated as such. In thinking about health care reform, it is time for this to stop. Those concerned about the direction of U.S. health care should start putting the finance horse before the benefits and delivery cart,” the authors conclude.
(JAMA. 2008;300[16]:1929-1931. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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Embargoed for Release: 10:00 a.m. ET, Tuesday, October 21, 2008
Media Advisory: To contact Ezekiel Emanuel, M.D., Ph.D., call the NIH Clinical Center Communications office at 301-496-2563.
COLLABORATION BETWEEN STATES, FEDERAL GOVERNMENT KEY TO HEALTH CARE REFORM
WASHINGTON, D.C.—In order to achieve comprehensive health care reform, states cannot do it alone. States and the federal government must partner and collaborate to overcome barriers and challenges to create high-quality, affordable health care, according to the authors of a commentary in the October 22/29 issue of JAMA, a theme issue on the Health of the Nation.
Ezekiel Emanuel, M.D., Ph.D., of the National Institutes of Health, Bethesda, Md., presented the commentary at a JAMA media briefing at the National Press Club in Washington, D.C.
Dr. Emanuel and co-author U.S. Senator Ron Wyden, J.D., write that when Massachusetts passed a health reform bill in 2006, numerous state legislatures met and sought to enact legislation providing health care for all state residents, but not one was successful. “States cannot reform health care on their own. Governors and state legislators, in concert with federal officials, must reconceive federal-state health care relations so that together they can meet the health care needs of all Americans.”
The barriers to states implementing substantial health care changes on their own are substantial. They include programs and factors out of states’ control: changing federal tax laws related to health insurance, self-insured employers regulated by ERISA (Employee Retirement Income Security Act), modifying Medicare and Medicaid, and the health coverage programs for federal employees in the state, the military, and veterans. Other barriers to state reform are the substantial costs with financing reform and reforming the health care delivery system. In fact, excluding Massachusetts' health reform bill, which is still in evolution, every time states have enacted a comprehensive reform effort it has failed.
Although states cannot make the changes alone, they can play three critical roles in health care reform. They can be facilitators, regulators, and innovators, the authors write. “First, states should be facilitators by creating and overseeing insurance exchanges. They are the logical place to develop insurance exchanges, manage enrollment, help state residents choose from a variety of plans to meet their needs, and provide informational materials to consumers and employers. In a new federal-state health partnership, the states should serve as the point of contact for self-employed individuals, workers in small businesses, and those who would be part of a reformed individual market.”
“Second, states should be important regulators. The logical place to regulate health insurance plans is at the state level. States oversee these plans today through insurance commissioners in each state. They should continue to protect consumers in a new federal-state health partnership, ensuring that plans sold in the state prohibit discrimination against individuals with preexisting illnesses, provide for fair marketing practices, and oversee grievances and appeals. States should oversee the development of standardized common claim forms and uniform billing practices to reduce administrative waste.”
“Third, states should be important innovators,” they write. “… states should be granted a broad waiver authority to develop innovative programs tailored to meet the unique needs of their citizens. In addition, neither the federal government nor business has taken sufficient initiative regarding wellness and prevention programs. States can develop novel programs around wellness and prevention that focus on the entire state population. … Plans could also push for the development of more effective uses of health information technologies. States could require insurance plans that enroll state workers to open electronic medical records for them at the expense of the private insurer.”
“The American public wants what only the federal government can guarantee—that all Americans, regardless of where they reside or work or any other characteristic, have high-quality, affordable health care. It is impossible to have one level of government oversee all aspects of health care for 300 million Americans. States will and should have a role in any comprehensive health care reform, but they cannot do it alone. The federal government will have to take initiative to achieve sustainable and successful reform,” the authors conclude.
(JAMA. 2008;300[16]:1931-1934. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see the article for additional information, including financial disclosures, funding and support, etc.
For More Information: Contact the JAMA/Archives Media Relations Department at 312/464-JAMA (5262) or email: mediarelations{at}jama-archives.org.
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JAMA REPORTS
VIDEO:
Windows Media |
Quicktime
RESEARCHERS STUDY U.S. FAMILIES IN WHICH AT LEAST ONE PARENT HAS HEALTH INSURANCE BUT THEIR CHILDREN DO NOT HAVE COVERAGE
INTRO:
When it comes to Americans without health insurance, many of them are children. But in a surprising twist, many of those uninsured children are from families with working parents who do have health insurance. Alissa Krinsky explains in this week’s JAMA Report.
VIDEO:
B-ROLL
Woman walking around store
Dissolve into Photo of grandson
AUDIO:
FRAN DENHAM HAS WORKED ALL HER LIFE TO PAY HER BILLS. FOR HEALTH INSURANCE, SHE IS COVERED THROUGH HER HUSBAND’S POLICY. BUT WHEN IT CAME TO HER GRANDSON, WHOM SHE RAISED, IT WAS TOO EXPENSIVE TO ADD HIM ONTO THE POLICY AS WELL.
VIDEO:
SOT/FULL
Super @ :15
Fran Denham
Insured, Raised Uninsured Child
Runs:10
AUDIO:
“It is very stressful, to have a kid that you’re responsible for…and you can’t take care of him the way you need to.”
VIDEO:
B-ROLL
Mother, daughter, doctor walk into exam room
AUDIO:
MORE THAN NINE MILLION U.S. CHILDREN ARE UNINSURED. DR. JENNIFER DEVOE - OF THE OREGON HEALTH AND SCIENCE UNIVERSITY - AND HER COLLEAGUES STUDIED DATA ON ALMOST FORTY-THOUSAND OF THEM.
VIDEO:
SOT/FULL
Super @ :38
Jennifer DeVoe, M.D.
Oregon Health & Science University
Runs :10
AUDIO:
"We found about three percent of children in the United States who are uninsured with an insured parent. And that translates to over three million children.”
VIDEO:
B-ROLL
GXF/JAMA COVER
AUDIO:
THE STUDY ON UNINSURED CHILDREN WHO HAVE AT LEAST ONE INSURED PARENT APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
Jennifer DeVoe, M.D.
Oregon Health & Science University
Runs :12
AUDIO:
“The largest predictor of children being uninsured, with an insured parent, was being in the middle income…earning somewhere between about 25,000 and 75,000 dollars a year, for a family of four.”
VIDEO:
B-ROLL
“Emergency” Sign
Ambulance with sirens
AUDIO:
SOME FAMILY INCOMES, THEREFORE, ARE TOO HIGH FOR THE KIDS TO QUALIFY FOR STATE INSURANCE PROGRAMS…BUT NOT HIGH ENOUGH FOR PARENTS TO AFFORD TO ADD THEIR CHILDREN TO EMPLOYER-SPONSORED POLICIES. OTHER FAMILIES DO QUALIFY FOR STATE PROGRAMS, BUT DON’T SIGN UP FOR NUMEROUS REASONS – FOR EXAMPLE, THEY FIND THE ENROLLMENT PROCESS CONFUSING.
VIDEO:
SOT/FULL
Jennifer DeVoe, M.D.
Oregon Health & Science University
Runs :11
AUDIO:
“It’s heartbreaking to know that we have a country that has figured out how to insure everyone over 65, and we can’t figure out how to insure everyone under eighteen, and then everyone in-between.”
VIDEO:
SOT/FULL
Fran Denham
Insured, Raised Uninsured Child
Runs :10
AUDIO:
“You just hope and hope and hope that nothing happens bad, because if it does, you’re up that creek – that nasty, dirty creek – without a paddle.”
VIDEO:
B-ROLL
Patient Exam Room
AUDIO:
IT’S A REALITY FOR MILLIONS OF AMERICANS, AND THEIR CHILDREN. ALISSA KRINSKY, THE JAMA REPORT.
TAG:
The four-year study also identified several factors associated with families who have an insured parent and uninsured children, including a likelihood the family is Hispanic…lives in the Southern or Western U.S….and has parents who did not finish high-school. For more information about this study you can log on to www.jama.com.
