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, April 17, 2007)
JAMA NEWS RELEASES
ANEMIA TREATMENT FOR PATIENTS WITH KIDNEY DISEASE CAN DIFFER BY DIALYSIS FACILITY TYPE
BENEFITS OF ANTIDEPRESSANTS APPEAR GREATER THAN RISKS FOR CHILDREN, TEENS
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
ANTIDEPRESSANTS SAFE AND EFFECTIVE IN CHILDREN AND TEENS
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TV Note: This week's JAMA Report video is onthe use of antidepressants among children and teens. The report will be fed Tuesday, April 17, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET, on Galaxy 26 (formerly Intelsat America 6) C-Band, Transponder 09, downlink frequency: 3880 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, April 17, 2007
Media Advisory: To contact corresponding author Dennis Cotter, M.S.E., call 301-652-4005. To contact editorial author Daniel W. Coyne, M.D., call Caroline Arbanas at 314-286-0109.
ANEMIA TREATMENT FOR PATIENTS WITH KIDNEY DISEASE CAN DIFFER BY DIALYSIS FACILITY TYPE
CHICAGO—Large, for-profit dialysis facilities appear to administer higher than necessary amounts of a medication for treating anemia in patients with kidney disease, compared to nonprofit facilities, according to a study in the April 18 issue of JAMA.
Anemia, a common complication of chronic kidney disease and end-stage renal disease (ESRD), occurs when there are too few red blood cells or the red blood cells are deficient in hemoglobin. The drug epoetin can be administered to increase red blood cell count to an appropriate range, and this is measured by hematocrit levels (the percentage of blood that is comprised of red blood cells).
“By 2005, 99 percent of in-center hemodialysis patients received epoetin treatment for their anemia,” the authors write. “Today, epoetin therapy is the largest single Medicare drug expenditure totaling $1.8 billion in 2004 (an increase of 17 percent from 2003) and epoetin comprised 11 percent of all Medicare ESRD costs.” The type of facility (profit, chain, and affiliation status) at which a patient receives dialysis may affect epoetin dosing patterns. Since 1991, epoetin payment has been based on the amount of drug administered, creating a financial incentive for increased use of this therapy, according to background information in the article. Several trials have failed to show a benefit of increasing hematocrit levels above the recommended range, while other trials have suggested possible adverse effects.
Mae Thamer, Ph.D., of the Medical Technology and Practice Patterns Institute, Bethesda, Md., and colleagues conducted a study to examine the relationship between organizational status and epoetin dosing. The researchers used the U.S. Renal Data System to identify 159,522 adult Medicare-eligible, end-stage renal disease patients who were receiving in-center hemodialysis during November and December 2004. The authors developed models to estimate the average epoetin dose and dose adjustment by profit, chain, and affiliation status.
Compared with patients in nonprofit dialysis facilities (n = 28,199), patients in large for-profit dialysis chain facilities (n = 106,116) were consistently administered the highest doses of epoetin regardless of anemia status. Dosing adjustments differed by type of facility. On average, compared with nonprofit facilities, for-profit facilities increased epoetin doses 3-fold for patients with hematocrit levels of less than 33 percent and also increased the doses among patients with hematocrit levels in the recommended target of 33 percent to 36 percent, especially in the largest for-profit chain facilities. The greatest difference in dosing practice patterns between facilities was found among patients with hematocrit levels of less than 33 percent.
“Our results indicate that facility ownership and chain status have a strong effect on epoetin dosing practice patterns. Compared with other facility types, we found that large for-profit chains administered higher epoetin doses, used higher dose increases, and had higher achieved hematocrit levels, as well as a larger proportion of patients above the upper limit of hematocrit level (target of 36 percent was recommended by the National Kidney Foundation and the U.S. Food and Drug Administration during the time of our study),” the authors write.
“In conclusion, these findings suggest that reimbursement policy and clinical performance measures may provide incentives for dialysis facilities, in particular for-profit facilities, to target hematocrit levels exceeding those recommended by the clinical guidelines. As existing guidelines are reevaluated, it will be important for policy makers to design an epoetin reimbursement policy that provides an incentive to achieve desired clinical outcomes while optimizing epoetin usage.”
(JAMA. 2007;297:1667-1674. 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: USE OF EPOETIN IN CHRONIC RENAL FAILURE
In an accompanying editorial, Daniel W. Coyne, M.D., of the Washington University School of Medicine, St. Louis, comments on the study on epoetin use in dialysis treatment centers.
“An unanswered question in the study by Thamer et al is why would nephrologists prescribe so much more epoetin, and make such dubious dosing decisions, when caring for patients at certain for-profit chains compared with patients treated at nonprofit facilities. Most nephrologists do not own dialysis facilities or profit from increased erythropoiesis stimulating agent [ESA; such as epoetin] use by facilities or chains.”
“Another important question is why for-profit dialysis chain facilities permit such management and whether they actually encourage or even orchestrate such management,” Dr. Coyne writes. “A third key question is whether anemia treatment guidelines for patients with renal failure should promote more prudent management.”
“The FDA has stated that the goal of ESA therapy is to reduce transfusions, and the risks and benefits in choosing to use an ESA must be carefully weighed for each patient. Because the FDA is responsible for drug safety, it is important that clinicians adhere to its recommendations.”
(JAMA. 2007;297:1713-1716. 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: 3:00 p.m. CT, Tuesday, April 17, 2007
Media Advisory: To contact corresponding author David A. Brent, M.D., call Jocelyn Uhl Duffy at 412-647-3555..
BENEFITS OF ANTIDEPRESSANTS APPEAR GREATER THAN RISKS FOR CHILDREN, TEENS
CHICAGO—A review of previous studies indicates that the benefits of antidepressants for children and teens with depression or anxiety disorders may outweigh their risks, and that the increased risk for suicidal thoughts and attempts is not statistically significant for depressed children and adolescents, according to an article in the April 18 issue of JAMA.
Previous research has indicated that the usage of antidepressants among children and adolescents is associated with an increased risk for suicidal behavior and thoughts, and resulted in the issuing of mandated label warnings on pediatric antidepressant medications by the FDA, according to background information in the article.
Jeffrey A. Bridge, Ph.D., of The Ohio State University, Columbus, and colleagues conducted a review and meta-analysis of randomized controlled trials involving the pediatric usage of antidepressants for major depressive disorder (MDD), obsessive-compulsive disorder (OCD), and non-OCD anxiety disorders, and included recent trials that had not been incorporated into previous analyses, to assess their benefits and effect on risk of suicidal thoughts and attempts. The researchers conducted a search for studies through 2006 and identified and included 27 pediatric trials for their analysis: MDD (n = 15), OCD (n = 6), and non-OCD anxiety disorders (n = 6).
The researchers found: “Consistent with the analyses of the FDA, we found evidence of an overall small but increased risk of treatment-emergent suicidal ideation/suicide attempt. However, the pooled random-effects risk differences of suicidal ideation/suicide attempt for each indication were all less than 1 percent. There were no completed suicides in these trials.”
“This meta-analysis of all available randomized clinical trials of antidepressant treatment of pediatric MDD, OCD, and non-OCD anxiety disorders shows evidence of efficacy for all three indications, although the effects were strongest for non-OCD anxiety disorders, intermediate for OCD, and more modest in MDD,” the authors write. Adolescents appeared to respond better than children to antidepressants in trials of both depression and anxiety.
“Some may argue that any risk of suicidal ideation/suicide attempt cannot possibly justify treatment with antidepressants for children and adolescents. Instead, we believe that the strength of evidence presented here supports the cautious and well-monitored use of antidepressant medications as one of the first-line treatment options, with the recognition that efficacy appears greatest for non-OCD anxiety disorders, intermediate for OCD, and more modest for MDD. Since the choice of treatment should be the result of a collaborative discussion between clinician, family, and patient, the information presented in this report should allow for an informed evaluation of the potential benefits and risks of these medications vs. no treatment and provide a framework for their comparison with nondrug treatments as well,” the researchers conclude.
(JAMA. 2007;297:1683-1696. 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
ANTIDEPRESSANTS SAFE AND EFFECTIVE IN CHILDREN AND TEENS
INTRO:
The Food and Drug Administration, or FDA, recently put a warning on antidepressants saying they increase suicide risk among teens. But a new study of about five-thousand children and teens shows that antidepressants are safe and effective. Mavis Prall explains in this week’s JAMA Report.
VIDEO:
B-ROLL
Black box warning wide
c/u language
GFX/JAMA COVER
AUDIO:
THIS IS A BLACK BOX WARNING FROM THE F.D.A, SAYING ANTIDEPRESSANTS INCREASE THE RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN AND ADOLESCENTS WITH MAJOR DEPRESSIVE DISORDER. BUT THE AUTHOR OF A NEW STUDY IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, SAYS:
VIDEO:
SOT/FULL
@ :16
Super: David Brent, M.D.
University of Pittsburgh Medical School
Runs :10
AUDIO:
“I think it’s important for the FDA to continue to monitor the safety of these medications, but on the basis of our study I think the black box warning should at least be reconsidered.”
VIDEO:
B-ROLL
Stay on bite through his name
Exterior tilt down
Middle-school kids getting off school bus/no faces showing
And older teens walking through mall – no faces showing
AUDIO:
DR. DAVID BRENT IS A PSYCHIATRIST AT UNIVERSITY OF PITTSBURGH MEDICAL SCHOOL. HE AND COLLEAGUES GATHERED STUDIES OF ABOUT FIVE-THOUSAND CHILDREN AND TEENS, TO COMPARE THE NUMBER OF KIDS WHO BENEFITED FROM ANTIDEPRESSANT USE TO THE NUMBER WHO BECAME SUICIDAL ON ANTIDEPRESSANTS.
VIDEO:
SOT/FULL
David Brent, M.D.
University of Pittsburgh Medical School
Runs :12
AUDIO:
“Less than one child in a hundred experienced an increased risk due to suicidal ideation and behavior, and there were very few actual suicide attempts and no suicide completions.”
VIDEO:
B-ROLL
Pharmacist counting pills – sequence
AUDIO:
THE ANTIDEPRESSANTS MOST BENEFITED KIDS WHO HAD ANXIETY DISORDERS. THEY ALSO HELPED THOSE WITH OBSESSIVE COMPULSIVE DISORDER, AND TO A LESSER EXTENT, THOSE WITH MAJOR DEPRESSIVE DISORDER.
VIDEO:
SOT/FULL
David Brent, M.D.
University of Pittsburgh Medical School
Runs :13
Cover edit in bite with teens
AUDIO:
“The effects were more modest for depression but the benefits were still much better than if you had done nothing… because there’s also a risk of doing nothing because depression is a potentially fatal illness if untreated.”
VIDEO:
B-ROLL
Dr. Murray in office with nurse looking at chart
AUDIO:
DR. PAMELA MURRAY IS A PEDIATRICIAN WHO SPECIALIZES IN ADOLESCENT MEDICINE.
VIDEO:
SOT/FULL
@ 1:23
Super: Pamela Murray, M.D.
Pediatrician/Adolescent Med. Specialist
Runs :08
AUDIO:
“Probably some days more than 50% of the patients who come here could potentially benefit from antidepressants.”
VIDEO:
B-ROLL
Pan of three antidepressant bottles (pills used in study)
AUDIO:
SHE SAYS SHE’S NOT AT ALL SURPRISED THAT ANTIDEPRESSANTS ARE MOST EFFECTIVE IN KIDS WITH ANXIETY DISORDERS.
VIDEO:
SOT/FULL
Pamela Murray, M.D.
Pediatrician/Adolescent Med. Specialist
Runs :14
AUDIO:
“My clinical experience has been that patients who go on antidepressants for anxiety disorders frequently report not only that they’re better but that their symptoms begin to abate quite quickly after they start medicines.”
VIDEO:
B-ROLL
Dr. Murray walking down hall with nurse, going into office
Antidepressant pills
AUDIO:
BUT SHE STRESSES AS WITH ALL TREATMENTS, PATIENTS NEED CAREFUL MONITORING TO BE SURE MEDICATIONS ARE WORKING THE WAY THEY SHOULD. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
TAG:
The National Institute of Mental Health provided most of the funding for this study. There was no funding for this study from pharmaceutical companies. For more information, visit www.jama.com.
