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 10, 2007)
JAMA NEWS RELEASES
STUDY FAILS TO VERIFY GENE VARIATIONS AS RISK FACTORS FOR CERTAIN CARDIOVASCULAR PROBLEMS
USE OF HYDROCORTISONE REDUCES INCIDENCE OF ATRIAL FIBRILLATION AFTER CARDIAC SURGERY
PRELIMINARY STUDY SUGGESTS USE OF STEM CELL TRANSPLANTATION IS BENEFICIAL TREATMENT OF TYPE 1 DIABETES
EXPERIMENTAL FLU VACCINE APPEARS PROMISING IN EARLY TESTS
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
STEM CELL TRANSPLANTATION MAY LEAD TO INSULIN INDEPENDENCE IN TYPE 1 DIABETES
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 use of stem cell transplantation for treating type 1 diabetes. The report will be fed Tuesday, April 10, 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.
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: 3:00 p.m. CT, Tuesday, April 10, 2007
Media Advisory: To contact Thomas M. Morgan M.D., call Diane Duke Williams at 314-286-0111.
STUDY FAILS TO VERIFY GENE VARIATIONS AS RISK FACTORS FOR CERTAIN CARDIOVASCULAR PROBLEMS
CHICAGO—New research has failed to confirm findings from smaller studies that 85 gene variations are associated with an increased risk for acute coronary syndromes (ACS), which includes heart attack and a type of angina, according to a study in the April 11 issue of JAMA.
Previous studies have identified a number of genetic variations as potential cardiovascular risk factors, but few, if any, have been established definitively. “Before use in clinical care, potential genetic risk factors would ideally be replicated en masse in large, well-characterized patient populations. To date, no such comprehensive validation of genetic variants potentially associated with ACS or atherosclerosis has been reported,” the authors write.
Thomas M. Morgan M.D., formerly of the Yale University School of Medicine, New Haven, Conn., and colleagues conducted a study to validate genetic risk factors for ACS. The researchers identified genetic variants previously reported as significant susceptibility factors for atherosclerosis or ACS through a literature search of published articles. This study included 811 patients with ACS and 650 age- and sex-matched controls who were genotyped for 85 variants in 70 genes and attempted to replicate previously reported associations.
Of 85 variants tested, only one of the gene variants was nominally statistically significant. Only four additional genes were positive in model-free analysis. Neither number of associations was more frequent than expected by chance, given the number of comparisons. Only 41 of 84 predefined risk variants were even marginally more frequent in cases than in controls (with 1 tie).
“We were unable to confirm as risk factors for ACS 85 genetic variants because none were unequivocally validated in this large case-control study of 1,461 participants,” the authors write. “We therefore conclude that our findings, in this large sample of well-characterized ACS patients and controls, cannot support that this panel of gene variants contains bona fide ACS risk factors.”
“Our findings come at a critical juncture in complex disease genetics. Some cardiovascular gene variants included in our study can already be ordered clinically, for indications that explicitly include possible ACS risk. However, our findings suggest that such clinical genetic testing is premature and underscore the importance of robust replication studies of reported associations prior to their application to clinical care.”
(JAMA. 2007;297:1551-1561. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Dr. Morgan is now with the Washington University School of Medicine, St. Louis. 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.
Go back to the top.
Embargoed for Release: 3:00 p.m. CT, Tuesday, April 10, 2007
Media Advisory: To contact Jari Halonen, M.D., email: jari.halonen{at}kuh.fi.
USE OF HYDROCORTISONE REDUCES INCIDENCE OF ATRIAL FIBRILLATION AFTER CARDIAC SURGERY
CHICAGO—Patients who receive corticosteroids after cardiac surgery have a significantly lower risk of atrial fibrillation in the days following the surgery, according to a study in the April 11 issue of JAMA.
Atrial fibrillation (AF) is the most common arrhythmia to occur after cardiac surgery. The incidence of AF has been reported to range between 20 percent and 40 percent after coronary artery bypass graft (CABG) surgery and is even higher after heart valve surgery and combined valve and bypass surgery, according to background information in the article. AF is associated with increased illness, including increased risk of stroke and need for additional treatment, with prolonged hospital stay and increased costs. A high inflammatory response after surgery has been thought to be partly responsible for AF.
Jari Halonen, M.D., of Kuopio University Hospital, Kuopio, Finland, and colleagues conducted a randomized multicenter trial to test whether intravenous corticosteroid administration prevents AF after cardiac surgery. The study, conducted at three university hospitals in Finland, included 241 patients without prior AF who were scheduled to undergo CABG surgery, aortic valve replacement, or combined CABG surgery and aortic valve replacement. Patients were randomized to receive either 100-mg hydrocortisone or matching placebo the evening of the operative day, then 1 dose every 8 hours during the next 3 days.
There were 94 patients who had AF during the first 84 hours after cardiac surgery. Patients randomized to the hydrocortisone group were significantly less likely to have AF than patients randomized to the placebo group (36/120 [30 percent] vs. 58/121 [48 percent]. The relative risk reduction was 37 percent. The first AF episode occurred later in patients randomized to the hydrocortisone group. The incidence of in-hospital AF was also significantly lower in the hydrocortisone group than in the placebo group. Compared with those receiving placebo, patients receiving hydrocortisone did not have higher rates of infections or major complications.
“We conclude that intravenous administration of hydrocortisone is efficacious and well tolerated in the prevention of AF after cardiac surgery. Larger trials will be needed to confirm our findings and determine short- and long-term safety of corticosteroids to prevent postoperative AF and other arrhythmias,” the authors write.
(JAMA. 2007;297:1562-1567. 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.
Go back to the top.
Embargoed for Release: 3:00 p.m. CT, Tuesday, April 10, 2007
Media Advisory: To contact Julio C. Voltarelli, M.D., Ph.D., email: jcvoltar{at}fmrp.usp.br. To contact co-author Richard K. Burt, M.D., call Marla Paul at 312-503-8928. To contact editorial author Jay S. Skyler, M.D., call William Kaufhold at 305-243-5184.
PRELIMINARY STUDY SUGGESTS USE OF STEM CELL TRANSPLANTATION IS BENEFICIAL TREATMENT OF TYPE 1 DIABETES
CHICAGO—A therapy that includes stem cell transplantation induced extended insulin independence in patients with type 1 diabetes mellitus, according to a preliminary study in the April 11 issue of JAMA.
Type 1 diabetes mellitus (DM) results from a cell-mediated autoimmune attack against pancreatic beta cells. At the time of clinical diagnosis, approximately 60 percent to 80 percent of the beta-cell mass has been destroyed, according to background information in the article. Beta-cell preservation has been shown to be an important target in the management of type 1 DM and in the prevention of its related complications.
Julio C. Voltarelli, M.D., Ph.D., of the University of São Paulo, Ribeirão Preto, Brazil, and colleagues conducted a study to examine the effect of high-dose immunosuppression followed by autologous nonmyeloablative hematopoietic stem cell transplantation (AHST) to preserve beta-cell function in 15 newly diagnosed patients with type 1 DM. AHST, which uses a patient’s own blood stem cells, involves the removal and treatment of the stem cells, and their return to the patient by intravenous injection.
During a 7 to 36-month follow-up, 14 patients became insulin-free (one for 35 months, four for at least 21 months, seven for at least six months; and two with late response were insulin-free for one and five months, respectively). Among those, one patient resumed insulin use one year after AHST. The only severe adverse effects were pneumonia in one patient and endocrine dysfunction in two others.
“This is, to our knowledge, the first report of high-dose immunosuppression followed by autologous nonmyeloablative hematopoietic stem cell transplantation for human type 1 DM. Very encouraging results were obtained in a small number of patients with early-onset disease. Ninety-three percent of patients achieved different periods of insulin independence and treatment-related toxicity was low, with no mortality. Further follow-up is necessary to confirm the duration of insulin independence and the mechanisms of action of the procedure. In addition, randomized controlled trials and further biological studies are necessary to confirm the role of this treatment in changing the natural history of type 1 DM and to evaluate the contribution of hematopoietic stem cells to this change,” the authors conclude.
(JAMA. 2007;297:1568-1576. Available 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: CELLULAR THERAPY FOR TYPE 1 DIABETES — HAS THE TIME COME?
In an accompanying editorial, Jay S. Skyler, M.D., of the Diabetes Research Institute, University of Miami Miller School of Medicine, Miami, comments on the study on type 1 diabetes and stem cell transplantation.
“This study by Voltarelli et al is the first of what likely will be many attempts at cellular therapy to interdict the type 1 DM disease process. Other approaches under consideration include infusion of dendritic cells, T-regulatory lymphocytes, umbilical cord cells, embryonic or adult stem cells, and allogenic bone marrow transplantation in addition to further studies with autologous hematopoietic stem cell transplantation. Research in this field is likely to explode in the next few years and should include randomized controlled trials as well as mechanistic studies. As these further studies confirm and build on the results of Voltarelli et al—the time may indeed be coming for starting to reverse and prevent type 1 DM.”
(JAMA. 2007;297:1599-1600. Available to the media at www.jamamedia.org)
Editor's Note: Please see the editorial 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.
Go back to the top.
Embargoed for Release: 3:00 p.m. CT, Tuesday, April 10, 2007
Media Advisory: To contact John J. Treanor, M.D., call Tom Rickey at 585-275-7954.
EXPERIMENTAL FLU VACCINE APPEARS PROMISING IN EARLY TESTS
CHICAGO—An influenza vaccine produced with the use of insect cells appeared safe and produced an immunogenic response in healthy adults, suggesting promise as an alternative to using embryonated eggs for the development of influenza vaccine, according to a preliminary study in the April 11 issue of JAMA.
“All currently licensed influenza vaccines in the United States are produced in embryonated hen’s eggs. There are several well-recognized disadvantages to the use of eggs as the substrate [the base on which an organism lives or grows] for influenza vaccine. Eggs require specialized manufacturing facilities and could be difficult to scale up rapidly in response to an emerging need such as a pandemic,” the authors write. They add that development of alternative substrates for influenza vaccine production has been identified as a high-priority. One potential alternative is use of the influenza virus hemagglutinin (HA; an antibody that causes red blood cells to clump together) using recombinant (genetic recombination) DNA techniques.
John J. Treanor, M.D., of the University of Rochester, N.Y., and colleagues evaluated an experimental influenza vaccine consisting of recombinant HA expressed in insect cells by a recombinant baculovirus (rHA0). The clinical trial was conducted at three U.S. academic medical centers during the 2004-2005 influenza season and included 460 healthy adults. Participants were randomly assigned to receive a single injection of saline placebo (n = 154); 75 μg of an rHA0 vaccine containing 15 μg of hemagglutinin from influenza A/New Caledonia/20/99(H1N1) and influenza B/Jiangsu/10/03 virus and 45 μg of hemagglutinin from influenza A/Wyoming/3/03 (H3N2) virus (n = 153); or 135 μg of rHA0 containing 45 μg of hemagglutinin each from all 3 components (n = 153). Serum samples were taken before and 30 days following immunization.
The researchers found: “We have shown that the rHA0 vaccine is well tolerated in healthy adults and immunogenic at both doses evaluated, and we obtained preliminary evidence of protection against influenza infection and disease. The safety data generated in this study are consistent with the safety profile observed in previous studies of rHA0 vaccine. These vaccines have been well tolerated at all doses administered and are associated with low rates of local reactions.”
“The use of recombinant DNA techniques to express proteins in cell culture has been a successful approach for generation of highly effective vaccines for the prevention of hepatitis B virus and human papillomavirus. Among the available expression technologies, recombinant baculovirus is especially well suited for production of influenza vaccine because the rapidity with which genes can be cloned and inserted into this vector facilitates updating the vaccine at regular intervals. In addition, the extraordinarily high yields of protein possible in this system provide the opportunity to use much higher and potentially more effective doses of vaccine. Expression of the HA protein in insect cells using recombinant baculovirus also avoids the need to work with potentially pathogenic live influenza viruses and the attendant biocontainment issues that would be a particular concern for generation of pandemic vaccines. The preliminary demonstration of protective efficacy in adults provides further support for the development of this promising approach for prevention of seasonal and pandemic influenza,” the authors conclude.
(JAMA. 2007;297:1577-1582. Available 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.
Go back to the top.
JAMA REPORTS
VIDEO: Windows Media | Quicktime
STEM CELL TRANSPLANTATION MAY LEAD TO INSULIN INDEPENDENCE IN TYPE 1 DIABETES
INTRO:
Type one diabetes is not as common as type two, but still affects millions of people, most of them young. Patients must regularly inject themselves with insulin to stay alive. But now researchers have tested a stem cell transplant procedure that appears to help free patients of the need for insulin or any other medications. Mavis Prall explains in this week’s JAMA Report.
VIDEO:
B-ROLL
Kim making a smoothie in her kitchen
cutaway cutting fruit
AUDIO:
FIFTEEN-YEAR-OLD KIM BLACK HAS HAD TYPE ONE DIABETES FOR TEN YEARS.
VIDEO:
SOT/FULL
@ :06
Super: Kim Black
Has Type 1 Diabetes
Runs :13
Cover bite/edits starting at “like when” with Kim drinking smoothie, at “where” Kim testing her blood until “and how” with her holding insulin pump, let shot run through next narration
AUDIO:
“I have to think about it 24/7, all the time, like when I’m going to eat next… where I’m going and if I have to bring a test kit…, and how much insulin I have to give myself and everything.”
VIDEO:
B-ROLL
Kim holding pump and running her other hand along the tube that leads to her side.
Cutaway to pump
Wide shot of Kim with pump
GFX/JAMA COVER
More shots of insulin pump
AUDIO:
KIM HAS AN INSULIN PUMP IMPLANTED IN HER SIDE, TO GIVE HER THE LIFE-SAVING MEDICATION SHE NEEDS ABOUT FIVE TIMES A DAY. BUT ACCORDING TO A STUDY IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, NEWLY-DIAGNOSED TYPE ONE DIABETES PATIENTS MAY BE FREED FROM NEEDING INSULIN, THROUGH A STEM CELL TRANSPLANT.
VIDEO:
SOT/FULL
@:37
Super: Richard Burt, M.D.
Northwestern University
Runs :09
AUDIO:
“These are not embryonic stem cells. These are your own circulating blood stem cells from the patient themselves.”
VIDEO:
B-ROLL
Dr. Burt working with samples under hood in lab, close-up samples, Dr. Burt taking them to microscope, looking through microscope
AUDIO:
DR. RICHARD BURT OF NORTHWESTERN UNIVERSITY DESIGNED THE STUDY, WHICH TOOK PLACE IN BRAZIL. THE GOAL WAS TO REPLACE PATIENTS’ FAULTY IMMUNE SYSTEMS, WHICH DESTROY ISLET CELLS IN THE PANCREAS, CAUSING DIABETES. DR. BURT CALLS THE IMMUNE SYSTEM THE POLICE FORCE, BECAUSE IT’S SUPPOSED TO PROTECT US FROM ILLNESS.
VIDEO:
SOT/FULL
Richard Burt, M.D.
Northwestern University
Runs :12
AUDIO:
“We go in and remove that entire police force and put in a new group of officers right out of the academy and they do what they’re supposed to do. That is they don’t attack normal good citizens.”
VIDEO:
B-ROLL
FULL SCREEN ANIMATION
Shows stem cells leaving patient’s arm through tube, close-up of stem cells, change of color to indicate frozen stem cells, patient hooked up to IV, lying in hospital bed, stem cells going back through tube into patient
AUDIO:
IN FIFTEEN PATIENTS, DOCTORS REMOVED THE PATIENTS’ OWN STEM CELLS FROM THEIR BLOOD AND FROZE THEM. THE PATIENTS UNDERWENT CHEMOTHERAPY FOR FOUR DAYS TO WEAKEN THEIR IMMUNE SYSTEMS. THAT WAY THEIR BODIES WERE MORE RECEPTIVE TO THE STEM CELLS WHEN DOCTORS PUT THEM BACK IN THE PATIENTS. THE PROCEDURE WAS SAFE IN ALL THE PATIENTS, AND EFFECTIVE IN ALL BUT ONE.
VIDEO:
SOT/FULL
Richard Burt, M.D.
Northwestern University
Runs :17
AUDIO:
“This is the first time in the history of diabetes that patients have gone an interval, an interval up to three years, and perhaps longer, only time will tell, requiring no treatment, no insulin, no immune suppression, no medications at all.”
VIDEO:
B-ROLL
Backtime bite
AUDIO:
THIS ALL SOUNDS GOOD TO KIM.
VIDEO:
SOT/FULL
Kim Black
Has Type 1 Diabetes
Runs :03
AUDIO:
“I don’t know what it’s like to live without type one diabetes.”
VIDEO:
B-ROLL
Kim testing her blood
AUDIO:
BUT SHE WISHES SHE COULD FIND OUT. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
TAG:
The patients were hospitalized for three weeks to undergo the transplant. But Dr. Burt says this procedure may only work on people who have recently been diagnosed with diabetes, because they still have some islet cells left in the pancreas. For more information, visit www.jama.com.
