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 p.m. CT Tuesday, December 2, 2008)
JAMA NEWS RELEASES
CONSUMING UP TO TWO DRINKS PER DAY NOT ASSOCIATED WITH INCREASED RISK OF IRREGULAR HEART BEAT FOR WOMEN
BRAND-NAME DRUGS DO NOT APPEAR SUPERIOR TO GENERIC DRUGS FOR TREATING CARDIOVASCULAR DISEASES
ANALYSIS SUPPORTS USE OF SURGERY TO TREAT MEDICATION-RESISTANT EPILEPSY
USE OF RAPID RESPONSE TEAM IN HOSPITAL NOT ASSOCIATED WITH REDUCTION IN CARDIOPULMONARY ARRESTS OR DEATHS
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
STUDY FINDS INCREASES IN LIFE EXPECTANCY AND QUALITY-OF-LIFE FOR PATIENTS WHO UNDERGO TEMPORAL LOBE EPILEPSY SURGERY
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
Please Note: This week's JAMA Report video is on the benefits of surgery for treating a certain type of epilepsy. The report will be fed Tuesday, December 2, 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.
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: 3:00 p.m. CT, Tuesday, December 2, 2008
Media Advisory: To contact David Conen, M.D., M.P.H., email: conend{at}uhbs.ch. To contact co-author Christine M. Albert, M.D., M.P.H., email: calbert{at}partners.org or call Holly Brown-Ayers at 617-534-1603.
CONSUMING UP TO TWO DRINKS PER DAY NOT ASSOCIATED WITH INCREASED RISK OF IRREGULAR HEART BEAT FOR WOMEN
CHICAGO—Women who have up to two alcoholic drinks per day do not appear to be at increased risk of atrial fibrillation (irregular heart beat), but drinking more than that amount is associated with a higher risk, according to a study in the December 3 issue of JAMA.
Studies assessing the effects of regular alcohol consumption on the risk of atrial fibrillation have provided inconsistent results, with several studies finding significant associations between moderate to high amounts of alcohol intake and increased risks of atrial fibrillation among men, but not among women. However, these studies were not of adequate size to detect significant associations among women, according to background information in the article.
David Conen, M.D., M.P.H., of Brigham and Women's Hospital, Harvard Medical School, Boston, and University Hospital, Basel, Switzerland, and colleagues analyzed data from a completed randomized controlled trial involving 34,715 women participating in the Women's Health Study, to assess the effects of regular alcohol consumption on the risk of atrial fibrillation. The participants were older than 45 years and had no atrial fibrillation at the start of the study and underwent follow-up from 1993 to October 2006. Alcohol consumption was assessed via questionnaires at the beginning of the trial and at 48 months of follow-up and was grouped into 4 categories: 0 drinks per day, greater than 0 and less than 1, 1 or more and less than 2, and 2 or more drinks per day. Atrial fibrillation was self-reported on the yearly questionnaires and subsequently confirmed by electrocardiogram and medical record review.
During a median (midpoint) follow-up of 12.4 years, there were 653 confirmed cases of new atrial fibrillation. Among women consuming no alcohol (n = 15,370), there were 294 events (1.9 percent); for women consuming more than 0 and less than 1 drink per day (n = 15,758), there were 284 events (1.8 percent); for 1 to 2 drinks per day (n = 2,228), there were 35 events (1.6 percent); and for women consuming 2 or more drinks per day (n = 1,359), there were 40 atrial fibrillation events (2.9 percent).
"In the present study, alcohol consumption of up to 2 drinks per day was not associated with an increased risk of incident atrial fibrillation among initially healthy, middle-aged women. In contrast, the small group of women who consumed 2 or more alcoholic beverages per day had a 1.6-fold greater risk for atrial fibrillation relative to nondrinking women. While this finding needs to be interpreted with some caution because of the small number of women in some subgroups, it supports a possible threshold effect in the relationship between alcohol consumption and risk of atrial fibrillation among women," the authors write.
(JAMA. 2008;300[21]:2489-2496. 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.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, December 2, 2008
Media Advisory: To contact Aaron S. Kesselheim, M.D., J.D., M.P.H., call Holly Brown-Ayers at 617-534-1603.
BRAND-NAME DRUGS DO NOT APPEAR SUPERIOR TO GENERIC DRUGS FOR TREATING CARDIOVASCULAR DISEASES
CHICAGO—Contrary to the perception of some patients and physicians, there is no evidence that brand-name drugs are clinically superior to their generic counterparts, according to an article in the December 3 issue of JAMA, which examined studies comparing the effectiveness of generic vs. brand-name drugs for treating cardiovascular diseases.
"The problem of rising prescription drug costs has emerged as a critical policy issue, straining the budgets of patients and public/private insurers and directly contributing to adverse health outcomes by reducing adherence to important medications. The primary drivers of elevated drug costs are brand-name drugs, which are sold at high prices during a period of patent protection and market exclusivity after approval by the Food and Drug Administration (FDA)," the authors write. To control spending, many payers and clinicians have encouraged substitution of inexpensive bioequivalent generic versions of these drugs after the brand-name manufacturer's market exclusivity period ends.
Some patients and physicians have expressed concern that generic drugs may not be equivalent in their effectiveness. "Brand-name manufacturers have suggested that generic drugs may be less effective and safe than their brand-name counterparts. Anecdotes have appeared in the lay press raising doubts about the efficacy and safety of certain generic drugs," the authors note.
Aaron S. Kesselheim, M.D., J.D., M.P.H., of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues assessed the clinical differences resulting from the use of generic medications or brand-name drugs used primarily to treat cardiovascular disease, which as a group make up the largest portion of outpatient prescription drug spending. The researchers conducted a meta-analysis on studies on this subject published from 1984 to August 2008, and to determine the expert opinion on the subject of generic substitution, also reviewed the content of editorials published during this time.
The researchers identified 47 articles for detailed analysis, covering nine different subclasses of cardiovascular drugs, of which 38 (81 percent) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100 percent) of beta-blockers, 10 of 11 RCTs (91 percent) of diuretics, 5 of 7 RCTs (71 percent) of calcium-channel blockers, 3 of 3 RCTs (100 percent) of antiplatelet agents, 2 of 2 RCTs (100 percent) of statins, 1 of 1 RCT (100 percent) of angiotensin-converting enzyme (ACE) inhibitors, and 1 of 1 RCT (100 percent) of alpha-blockers.
Among narrow therapeutic index drugs (NTI; drugs whose effective doses and toxic doses are separated by a small difference in plasma concentration), clinical equivalence was reported in 1 of 1 RCT (100 percent) of class 1 anti-arrhythmic agents and 5 of 5 RCTs (100 percent) of warfarin.
Forty-three editorials and commentaries were identified as meeting study criteria. Of these editorials, 23 (53 percent) expressed a negative view of the interchangeability of generic drugs compared with 12 (28 percent) that encouraged substitution of generic drugs (the remaining 8 did not reach a conclusion on interchangeability). Among editorials addressing NTI drugs specifically, 12 (67 percent) expressed a negative view while only 4 (22 percent) supported generic drug substitution.
"One explanation for this discordance between the data and editorial opinion is that commentaries may be more likely to highlight physicians' concerns based on anecdotal experience or other nonclinical trial settings. Another possible explanation is that the conclusions may be skewed by financial relationships of editorialists with brand-name pharmaceutical companies, which are not always disclosed. Approximately half of the trials in our sample (23/47, 49 percent), and nearly all of the editorials and commentaries, did not identify sources of funding," the researchers write.
The researchers also reported, "...we identified numerous studies that evaluated differences in clinical outcomes with generic and brand-name medications. Our results suggest that it is reasonable for physicians and patients to rely on FDA bioequivalence rating as a proxy for clinical equivalence among a number of important cardiovascular drugs, even in higher-risk contexts such as the NTI drug warfarin. These findings also support the use of formulary designs aimed at stimulating appropriate generic drug use. To limit unfounded distrust of generic medications, popular media and scientific journals could choose to be more selective about publishing perspective pieces based on anecdotal evidence of diminished clinical efficacy or greater risk of adverse effects with generic medications. Such publications may enhance barriers to appropriate generic drug use that increase unnecessary spending without improving clinical outcomes."
(JAMA. 2008;300[21]:2514-2526. 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.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, December 2, 2008
Media Advisory: To contact Hyunmi Choi, M.D., M.S., call Elizabeth Streich at 212-305-6535. To contact editorial author Jerome Engel, Jr., M.D., Ph.D., call Mark Wheeler at 310-794-2265.
ANALYSIS SUPPORTS USE OF SURGERY TO TREAT MEDICATION-RESISTANT EPILEPSY
CHICAGO—Persons with temporal lobe epilepsy who do not respond to medication could receive a substantial gain in life expectancy and quality of life by undergoing surgery of the temporal lobe part of the brain, according to an analysis reported in the December 3 issue of JAMA.
Despite currently available anti-epileptic drugs, 20 percent to 40 percent of all patients with epilepsy do not respond to medical management. Temporal lobe epilepsy is the most common form of epilepsy and the most likely to be medically non-responsive, and these patients are at increased risk of premature death, according to background information in the article. An alternative form of treatment is temporal lobe resection (procedure in which brain tissue in the temporal lobe is cut away). Patients becoming seizure free after anterior (toward the front) temporal lobe resection have reduced death rates relative to patients continuing to have seizures.
"Studies have reported the effectiveness of temporal lobe resection since the 1950s, yet a minority of patients are being referred to surgery and those only after an average of 20 years of illness. For adolescents and young adults, this delay may be particularly significant during a critical period in their psychosocial development," the authors write.
Hyunmi Choi, M.D., M.S., of the Columbia University Medical Center, New York, and colleagues conducted an analysis using a simulation model to estimate the effect of anterior temporal lobe resection vs. continued medical management on life expectancy and quality-adjusted life expectancy among patients with medication-resistant temporal lobe epilepsy. The model incorporated possible surgical complications and seizure status and was populated with health-related quality-of-life data obtained directly from patients and data from the medical literature.
Model predictions of being seizure-free 5 years and 10 years after anterior temporal lobe resection were consistent with results from published studies. The researchers found that anterior temporal lobe resection would increase life expectancy by 5.0 years, with surgery preferred in 100 percent of the simulations, and that resection would increase quality-adjusted life expectancy by 7.5 quality-adjusted life-years, with surgery preferred in 96.5 percent of the simulations.
For a 35-year-old patient, the model suggests that anterior temporal lobe resection increased the number of seizure-free years by 15.0 and reduced the lifetime absolute risk of dying from seizure-related causes by 15 percent.
"For patients with pharmacoresistant temporal lobe epilepsy and neurologists, these results provide an additional perspective for comparing the relative benefits of epilepsy surgery vs. continued medical management," the authors write. "Referral of patients in a timely manner is crucial, because factors such as older age at surgery and longer duration of epilepsy are associated with a lower likelihood of becoming seizure-free after anterior temporal lobe resection. Referral to a specialized epilepsy surgery program should be considered when at least 2 appropriate antiepileptic drugs have been tried at maximum tolerable doses and when patients are experiencing disabling partial-onset seizures."
(JAMA. 2008;300[21]:2497-2505. 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: SURGICAL TREATMENT FOR EPILEPSY—TOO LITTLE, TOO LATE?
Jerome Engel, Jr., M.D., Ph.D., of the David Geffen School of Medicine at University of California, Los Angeles, comments on the findings of Choi and colleagues in an accompanying editorial.
"Surgical treatment for epilepsy remains underused, and when surgery is performed, it is often delayed until it is too late to reverse associated severe disabilities. The study by Choi et al underscores, but most likely underestimates, the benefits of surgical therapy for temporal lobe epilepsy. More information is needed to better understand the natural history of intractable temporal lobe epilepsy and to identify factors that reliably predict which patients will continue to have persistent seizures and thereby enable an accurate prediction of surgical benefit early in the course of antiepileptic drug treatment, before the disabling psychological and social consequences of recurrent seizures become irreversible."
"In the meantime, however, the best approach to facilitate early surgical treatment, when appropriate, would be for primary care physicians and general neurologists to refer patients who continue to have disabling seizures after a few antiepileptic drugs have failed to an epilepsy center for additional evaluation. Epileptologists at these centers are specifically trained to carry out the testing necessary to determine whether early surgical therapy is a viable option."
(JAMA. 2008;300[21]:2548-2550. 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.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, December 2, 2008
Media Advisory: To contact Paul S. Chan, M.D., M.Sc., call John Austin at 816-235-5251.
USE OF RAPID RESPONSE TEAM IN HOSPITAL NOT ASSOCIATED WITH REDUCTION IN CARDIOPULMONARY ARRESTS OR DEATHS
CHICAGO—Although there is an effort to implement rapid response teams in hospitals throughout the country, new research suggests that they do not result in a reduced rate of cardiopulmonary arrests or deaths, according to a study in the December 3 issue of JAMA.
Previous studies have found that patients often exhibit physiological deterioration hours before cardiopulmonary arrest. A rapid response team, also known as a medical emergency team, is a multidisciplinary team of intensive care unit (ICU) professionals charged with the evaluation, triage, and treatment of non-ICU patients with signs of clinical deterioration to reduce the rates of in-hospital cardiopulmonary arrests (codes) and the subsequent illness or deaths that follow. The Institute for Healthcare Improvement has recommended that hospitals implement rapid response teams as 1 of 6 strategies to reduce preventable in-hospital deaths. In response, hundreds of hospitals around the country have invested significant financial and personnel resources in implementing rapid response teams, despite limited published data supporting their effectiveness, according to background information in the article.
Paul S. Chan, M.D., M.Sc., of the Mid America Heart Institute and University of Missouri, Kansas City, and colleagues examined the association between a rapid response team intervention and long-term changes in hospital-wide cardiopulmonary arrest and mortality rates. The study included adult inpatients admitted between January 2004 and August 2007 at a 404-bed tertiary care academic hospital in Kansas City. Rapid response team education and program rollout occurred from September 1 to December 31, 2005. A total of 24,193 patient admissions were evaluated prior to the intervention (January 1, 2004 to August 31, 2005), and 24,978 admissions were evaluated after the intervention (January 1, 2006 to August 31, 2007).
During the 20-month period after intervention implementation, there were a total of 376 rapid response team activations. The most common reasons for rapid response team activation were altered neurological status, tachycardia (abnormally rapid heartbeat) exceeding 130 beats per minute, tachypnea (abnormally rapid breathing) exceeding 30 breaths per minute, and hypotension (abnormally low blood pressure) assessed as blood pressure lower than 90 mm Hg.
Hospital-wide code rates per 1,000 admissions were 11.2 before rapid response team intervention and 7.5 after rapid response team intervention. This was not associated with a reduction in the primary outcome measure of hospital-wide code rates, with decreases in non-ICU code rates accounting for the majority of this difference.
Case fatality rates after cardiopulmonary arrest were similar prior to and after the rapid response team intervention (77.9 percent vs. 76.1 percent). Hospital-wide mortality rates did not meaningfully change after the rapid response team intervention (3.22 preintervention vs. 3.09 postintervention per 100 admissions). Secondary analyses revealed few instances of rapid response team undertreatment or underuse that may have affected the mortality findings.
"We believe that this study provides important new insights regarding the effectiveness and limitations of rapid response team intervention and raises critical questions about whether recommendations to disseminate rapid response teams nationally are warranted without a demonstrable mortality benefit," the authors write.
(JAMA. 2008;300[21]:2506-2513. 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.
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JAMA REPORTS
VIDEO:
Windows Media |
Quicktime
STUDY FINDS INCREASES IN LIFE EXPECTANCY AND QUALITY-OF-LIFE FOR PATIENTS WHO UNDERGO TEMPORAL LOBE EPILEPSY SURGERY
INTRO:
Temporal lobe epilepsy is the most common form of epilepsy, causing seizures that are often resistant to medical treatment. And so some patients choose to undergo anti-seizure surgery. Now, a new study shows that in addition to eliminating seizures, the surgery may provide some other significant benefits. Alissa Krinsky explains in this week's JAMA Report.
VIDEO:
B-ROLL
family leaving house, walk to car
AUDIO:
SCOTT HARDING, A HUSBAND, FATHER, AND POLICE DETECTIVE SPECIALIST, HAD ALWAYS HAD GOOD HEALTH. BUT FOUR YEARS AGO, HE BEGAN HAVING SEIZURES. HE WAS DIAGNOSED WITH TEMPORAL LOBE EPILEPSY, THE MOST COMMON FORM OF EPILEPSY.
VIDEO:
SOT/FULL
Scott Harding
Had Temporal Lobe Epilepsy Surgery
Runs: :02
AUDIO:
"It was eye-opening. It was humbling."
VIDEO:
B-ROLL
Scott playing soccer with family
AUDIO:
TREATMENT WITH MEDICATION FAILED TO HELP – A COMMON RESISTANCE. SCOTT UNDERWENT SURGERY.
VIDEO:
SOT/FULL
Super @ :23
Scott Harding
Had Temporal Lobe Epilepsy Surgery
Runs :09
AUDIO:
"I have not had a seizure since the surgery. I’m seizure free for over three years."
VIDEO:
B-ROLL
Doctor walking down hall, into office
AUDIO:
DOCTOR HYUNMI (Hyun’-mee) CHOI OF COLUMBIA UNIVERSITY MEDICAL CENTER – AND HER COLLEAGUES – DECIDED TO COMPARE THE LONG-TERM EFFECTS OF TREATING TEMPORAL LOBE EPILEPSY WITH SURGERY VERSUS MEDICATION.
VIDEO:
SOT/FULL
Super @ :42
Hyunmi Choi, M.D.
Columbia University Medical Center
Runs :12
AUDIO:
"The goal of the study was to determine the increase in length of life that might be associated with either epilepsy surgery – temporal lobe epilepsy surgery – or medication management."
VIDEO:
B-ROLL
GXF/JAMA COVER
GFX:
Temporal Lobe Epilepsy Surgery
For 35 Year-Old Patient...
- Improves Quality and Length of Life
- Increases Life Expectancy: 5 Years
- Increases Seizure-Free Years: 13 Years
AUDIO:
THE STUDY – THE FIRST OF ITS KIND - APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. IT SHOWED THAT, ON AVERAGE, FOR A THIRTY-FIVE YEAR OLD PATIENT, THE SURGERY IMPROVES QUALITY AND LENGTH OF LIFE... INCREASING LIFE EXPECTANCY BY ALMOST FIVE YEARS…AND INCREASING THE NUMBER OF SEIZURE-FREE YEARS BY MORE THAN THIRTEEN.
VIDEO:
SOT/FULL
Hyunmi Choi, M.D.
Columbia University Medical Center
Runs :08
AUDIO:
"The biggest benefit of surgery is significant improvement in seizure control compared to medication management."
VIDEO:
B-ROLL
Doctor standing at bookshelf with book
AUDIO:
THERE ARE RISKS OF SURGICAL SIDE EFFECTS – INCLUDING INFECTION AND MEMORY PROBLEMS. BUT DOCTOR CHOI SAYS THAT FOR SOME PATIENTS SURGERY IS AN OPTION WORTH CONSIDERING.
VIDEO:
SOT/FULL
Hyunmi Choi, M.D.
Columbia University Medical Center
Runs :13
AUDIO:
"If seizures are not completely controlled by at least two different medications, patients should consider getting a further evaluation and consider epilepsy surgery as a possibility."
VIDEO:
SOT/FULL
Scott Harding
Had Temporal Lobe Epilepsy Surgery
Runs :13
AUDIO:
"I have my life back. It is an incredible feeling to be able to control your life, to feel confident that this problem that you experienced is gone."
VIDEO:
B-ROLL
Scott kicking soccer ball
AUDIO:
CONFIDENCE OF A BETTER QUALITY OF LIFE. ALISSA KRINSKY, THE JAMA REPORT.
TAG:
The study was conducted by analyzing data - using computer simulation models - along with interviews of patients who have undergone temporal lobe epilepsy surgery. The surgery is not commonly performed – it’s utilized by only a small percentage of eligible patients. For more information about this study you can log on to www.jama.com.
