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
(Embargoed for Release: 3:00 p.m. CT, Tuesday, August 8, 2006)
JAMA NEWS RELEASES
FDA SAFETY ALERTS FOR AUTOMATED EXTERNAL DEFIBRILLATORS OCCUR FREQUENTLY
VARIABILITY IN CERTAIN GENE ASSOCIATED WITH INCREASED RISK OF PARKINSON DISEASE
SUB-SAHARAN AFRICANS WITH HIV MAY ACHIEVE FAVORABLE LEVELS OF ANTIRETROVIRAL THERAPY ADHERENCE
JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)
VIDEO: Windows Media | Quicktime
RECALL RATE ON AUTOMATED EXTERNAL DEFIBRILLATORS IS 20 PERCENT
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
Save the Date: JAMA will present new research on HIV/AIDS at a media briefing on Sunday, August 13, from 10 a.m. – 12:15 p.m., at the International AIDS Conference in Toronto. Program and registration information is included at the end of this email.
TV Note: This week's JAMA video news release is on recalls and safety alerts affecting automated external defibrillators. The release will be fed Tuesday, August 8, from 9:00 - 9:30 a.m. ET on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Intelsat America 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).
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Embargoed for Release: 3:00 p.m. CT, Tuesday, August 8, 2006
Media Advisory: To contact William H. Maisel, M.D., M.P.H., call Bonnie Prescott at 617-667-7306.
To contact editorial author N. A. Mark Estes III, M.D., call Catherine Bromberg at 617-636-0200.
FDA SAFETY ALERTS FOR AUTOMATED EXTERNAL DEFIBRILLATORS OCCUR FREQUENTLY
CHICAGO—The FDA frequently issues safety advisories for automated external defibrillators (portable electronic device used to restore regular heart beat in patients with cardiac arrest) and accessories, although the number of actual device malfunctions appears to be relatively small, according to a study in the August 9 issue of JAMA.
Sudden cardiac death is a leading cause of death in the United States, accounting for nearly 330,000 deaths annually. Successful resuscitation of persons with cardiac arrest depends on prompt emergency care, with early defibrillation a key component to improved survival. The use of automated external defibrillators (AEDs) and their increasingly widespread distribution in public places, including many airports, sports arenas, and shopping centers, has resulted in the saving of innumerable lives, according to background information in the article. AEDs are easy to use, but are technically complex devices that occasionally malfunction. The U.S. Food and Drug Administration (FDA) is responsible for the safety and oversight of medical devices in the United States, and occasionally issues recalls and safety alerts (collectively referred to as “advisories”), a number of which have involved AEDs. Little is known about the reliability of AEDs.
Jignesh S. Shah, M.D., and William H. Maisel, M.D., M.P.H., of Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, analyzed weekly FDA Enforcement Reports between Jan. 1996 and Dec. 2005 to identify all recalls and safety alerts involving AEDs and AED accessories. Confirmed AED device malfunctions were identified by reviewing AED-related adverse events reported to the FDA.
There were 52 advisories (4.5 per year) during the study period, affecting 385,922 AEDs and AED accessories. Automated external defibrillators were recalled in 9 of the 10 study years, and AED accessories were recalled in 7 of the 10 years studied. No year was advisory free. Overall, 21.2 percent of AEDs were affected by advisories during the study period, most often due to electrical or software problems. Every major AED manufacturer recalled products during the study period. Recalls and safety alerts more often involved AEDs than AED accessories.
“This study reassuringly demonstrates that despite increasing AED complexity, the AED advisory rate did not significantly increase during the study period. However, AED and AED accessory advisories do occur frequently. The annual number of AED advisories and the annual number of AEDs affected by advisories increased, and numerous confirmed AED malfunctions occurred during the past decade. Still, the total number of device malfunctions is small compared with the number of lives saved. Indeed, hundreds of thousands of patients underwent attempted resuscitation of ventricular arrhythmias by an AED during the study period accounting for thousands of lives saved,” the authors write.
“As the prevalence of AEDs continues to increase, the number of devices affected by advisories can also be expected to increase. Efforts should be directed at developing a reliable system to locate and repair potentially defective devices in a timely fashion.”
(JAMA. 2006;296:655-660. 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: AUTOMATED EXTERNAL DEFIBRILLATORS — DEVICE RELIABILITY AND CLINICAL BENEFITS
In an accompanying editorial, N. A. Mark Estes III, M.D., of the New England Medical Center and Tufts University School of Medicine, Boston, comments on the findings of Drs. Shah and Maisel.
“While efforts to develop rigorous mechanisms to accurately monitor device performance will undoubtedly have costs, these efforts are essential to achieve the best possible clinical outcomes. Device manufacturers and the federal government should allocate the funds required to make this effort successful. Initial steps should be guided by knowledge that many advisory AEDs remain in service and have not been appropriately evaluated. Additional measures to accurately track those who purchase and use these devices are needed. Subsequent measures will require the best efforts of health care professionals, regulators, manufacturers, and the public working collaboratively to develop a transparent, rigorous, and systematic approach using the best practices of evidence-based medicine in postmarketing surveillance. From these efforts, guidelines for monitoring, communicating, and performance should be established. During cardiac arrest, when each minute really matters for survival, all stakeholders share the duty of ensuring the highest possible standards of AED reliability.”
(JAMA. 2006;296:700-702. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Financial disclosure - Dr. Estes reports that he has served on the speaker’s bureau and has received honoraria from Medtronic, Guidant, and St. Jude Medical and that he has served as an expert witness in Stone vs. Frontier.
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: 3:00 p.m. CT, Tuesday, August 8, 2006
Media Advisory: To contact Demetrius M. Maraganore, M.D., call Lisa Lucier at 507-284-5005.
VARIABILITY IN CERTAIN GENE ASSOCIATED WITH INCREASED RISK OF PARKINSON DISEASE
CHICAGO—Variability in the SNCA gene is linked with a greater susceptibility for Parkinson disease, according to a study in the August 9 issue of JAMA.
Parkinson disease is a common neurological condition associated with increased illness and shortened life expectancy. The origin of Parkinson disease remains elusive, but genetic factors may be important, according to background information in the article. One of the most promising leads in the genetics of Parkinson disease is the potential role of the alpha-synuclein (SNCA) gene. Studies have revealed several SNCA mutations that cause Parkinson disease, but large-scale studies have been lacking.
Demetrius M. Maraganore, M.D., of the Mayo Clinic College of Medicine, Rochester, Minn., and colleagues with the Genetic Epidemiology of Parkinson’s Disease (GEO-PD) Consortium, conducted a study to examine several issues, including whether allele-length (one of a number of alternative forms of the same gene occupying a given position on a chromosome) variability in the dinucleotide repeat sequence (REP1) of the SNCA gene is associated with Parkinson disease susceptibility. The researchers performed a collaborative analysis of individual-level data on SNCA REP1 and flanking markers in patients with Parkinson disease and controls. Study site recruitment, data collection, and analyses were performed between April 4, 2004, and December 31, 2005. Eleven participating sites of a global genetics consortium provided clinical data for 2,692 cases and 2,652 controls.
The researchers found that genotypes defined by the 263 base-pair allele were associated with Parkinson disease.
“Our study demonstrates that the SNCA gene is not only a rare cause of autosomal dominant Parkinson disease in some families, but also a susceptibility gene for Parkinson disease at the population level. Based on our results, we estimate that REP1 locus variability may explain approximately 3 percent of the risk in the general population. This is in the same range as the population effect of other common variants implicated in Parkinson disease. The additive effects of these and other common gene variants may ultimately account for a substantial fraction of the susceptibility to Parkinson disease,” the authors write.
(JAMA. 2006;296:661-670. 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: 3:00 p.m. CT, Tuesday, August 8, 2006
Media Advisory: To contact co-author Gordon H. Guyatt, M.D., M.Sc., call Susan Emigh at 905-525-9140, ext. 22555.
SUB-SAHARAN AFRICANS WITH HIV MAY ACHIEVE FAVORABLE LEVELS OF ANTIRETROVIRAL THERAPY ADHERENCE
CHICAGO—A review of previous studies suggests that favorable levels of antiretroviral therapy adherence can be reached among HIV-infected patients in sub-Saharan Africa, while adherence remains a concern in North America, according to an analysis reported in the August 9 issue of JAMA.
Antiretroviral therapy (ART) has improved the health of many human immunodeficiency virus (HIV) positive individuals who otherwise would have died. However, treatment effectiveness relies on sustained adherence, which is a serious challenge to those receiving ART, according to background information in the article. The regimens are often complicated, can include varying dosing schedules, dietary restrictions, and adverse effects. Consistently high levels of adherence are necessary for reliable viral suppression and prevention of resistance, disease progression, and death. There has been concern that African patients, many of whom live in poverty and lack formal education, will have suboptimal adherence to ART.
Edward Mills, Ph.D., M.Sc., of the Centre for International Health and Human Rights Studies, Toronto, Ontario, Canada, and colleagues conducted a review of available ART adherence data in both Africa and a resource-rich setting, North America, to determine the level of adherence in emerging African treatment programs relative to the more established North American programs. Eleven electronic databases were searched along with major conference abstract databases (inclusion dates: inception of database up until April 18, 2006) for all English-language articles and abstracts; and researchers and treatment advocacy groups were contacted.
Thirty-one studies from North America and 27 studies from sub-Saharan Africa were included. African studies represented 12 sub-Saharan countries. Of the North American studies, 71 percent used patient self-report to assess adherence; this was true of 66 percent of African assessments. The researchers found that North American studies (17,573 patients total) yielded a pooled estimate of 55 percent of the populations achieving adequate levels of adherence and African studies (12,116 patients total) yielded a pooled estimate of 77 percent, indicating a higher level of ART adherence in Africa.
“The findings from this systematic review and meta-analysis suggest that ART adherence among sub-Saharan African patients in early treatment programs are favorable, although it should be noted that the complexity of treatment regimens is potentially greater in North America, which should be considered when interpreting the data,” the authors write.
The researchers add that the barriers to adherence among impoverished individuals in North America appear to be due to poor patient-clinician relationships, untreated depression, substance abuse, and other factors that are common among poor individuals in the North America setting rather than poverty itself.
“We have shown that there are patients in both settings that have suboptimal adherence and that factors beyond poverty play an important role. Clinicians should therefore proactively inquire with patients about current barriers or facilitators of adherence to HIV medications,” they write.
“The findings of this analysis have important policy implications. First, the expectation of poor adherence in Africa is not an evidence-based rationale for delaying the expansion of ART programs in resource-poor settings. Second, given the average relatively high levels of adherence in resource-poor settings documented in this analysis, the focus (or priority) must now be to maintain these ART adherence rates by increasing access to affordable ART and establishing reliable drug supply and distribution networks from the pharmacy to the individual patient. Third, understanding culturally specific barriers to adherence will be important in developing evidence-based interventions targeted at the individuals with poor ART adherence,” the authors conclude.
(JAMA. 2006;296:679-690. 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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JAMA REPORTS
VIDEO: Windows Media | Quicktime
RECALL RATE ON AUTOMATED EXTERNAL DEFIBRILLATORS IS 20 PERCENT
VIDEO:
B-ROLL
Angelo walking down street
AUDIO:
SIXTY-NINE YEAR OLD ANGELO URBANI (er-BAH-nee) FEELS FINE NOW, BUT A FEW YEARS AGO HE WENT INTO CARDIAC FIBRILLATION – HIS HEART STARTING RACING SO FAST HE PASSED OUT.
VIDEO:
SOT/FULL
@ :10
Super: Angelo Urbani
Resuscitated by AED
Runs: 11
AUDIO:
“The EMTs came down and from what I understand the fire department and everybody and I guess they got me on the second shot with those paddles and then I woke up in the hospital.”
VIDEO:
B-ROLL
Rush University Medical Center health care workers taking class using mannequins and AEDS
AUDIO:
THOSE PADDLES ARE PART OF THIS, AN AUTOMATED EXTERNAL DEFIBRILLATOR, OR AED. IT SENDS ELECTRICAL SHOCKS THROUGH THE CHEST THAT CAN MAKE THE HEART BEAT NORMALLY AGAIN. EMERGENCY MEDICAL WORKERS AREN’T THE ONLY ONES WHO HAVE THESE DEVICES.
VIDEO:
SOT/FULL
@ :34
Super: William Maisel, M.D., M.P.H.
Beth Israel Deaconess Medical Center
Runs :12
AUDIO:
“There are AEDs throughout airports, casinos, a church may decide to buy an AED, a school, and apartment building. There are also AEDs that are available for home use without a prescription.”
VIDEO:
B-ROLL
Bite runs through his name
Exterior of BIDMC
AED device/Dr. Maisel demonstrating
GFX/JAMA COVER
AUDIO:
DR.WILLIAM MAISEL (mays-ELL) OF BETH ISRAEL DEACONESS MEDICAL CENTER IN BOSTON REVIEWED ALL THE AED RECALLS THE FOOD AND DRUG ADMINISTRATION AND DEVICE MANUFACTURERS ISSUED BETWEEN 1996 AND 2005. THE FINDINGS APPEAR IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
William Maisel, M.D., M.P.H.
Beth Israel Deaconess Medical Center
Runs :10
AUDIO:
“The chances that your AED would be recalled in any given year was one in twenty. The chances that your AED would be recalled during the entire 10-year study period was one in five.”
VIDEO:
B-ROLL
Bite runs until “looked at”
Full screen graphic
Title: AED Malfunction Rates 1996-2005
775,389 AEDs in circulation
370 fatal AED-related malfunctions
AUDIO:
DR. MAISEL SAYS THAT’S A HIGH RECALL RATE, BUT HE ALSO LOOKED AT MALFUNCTION RATES. OUT OF MORE THAN 775-THOUSAND AEDS IN CIRCULATION DURING THE STUDY, THERE WERE THREE-HUNDRED AND SEVENTY FATAL AED-RELATED MALFUNCTIONS.
VIDEO:
SOT/FULL
William Maisel, M.D., M.P.H.
Beth Israel Deaconess Medical Center
Runs :10
AUDIO:
“The number of malfunctions pales in comparison to the number of lives that have been saved by these important devices over the past decade.”
VIDEO:
B-ROLL
AED device/Dr. Maisel demonstrating
AUDIO:
STILL, HE SAYS THE FDA AND MANUFACTURERS NEED TO DEVELOP A BETTER RECALL NOTIFICATION SYSTEM, AND...
VIDEO:
SOT/FULL
William Maisel, M.D., M.P.H.
Beth Israel Deaconess Medical Center
Runs :11
AUDIO:
“People who purchase a device should return the card that comes with the device so that they can register their name and address with the manufacturer, so they can be directly contacted if their device has a problem.”
VIDEO:
B-ROLL
Dr. Maisel examining Angelo
AUDIO:
ANGELO SAYS IF THERE’D BEEN A PROBLEM WITH THE AED USED ON HIM...
VIDEO:
SOT/FULL
Angelo Urbani
Resuscitated by AED
Runs: 02
AUDIO:
“I probably would have gone to the next world.”
VIDEO:
B-ROLL
Angelo walking away
AUDIO:
THIS IS MAVIS PRALL WITH THE JAMA REPORT.
