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January 8, 2008

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, January 8, 2008)


JAMA NEWS RELEASES

>   RURAL PATIENTS LESS LIKELY TO RECEIVE ORGAN TRANSPLANTS

>   NEWER MENINGITIS VACCINE APPEARS SAFE AND EFFECTIVE FOR INFANTS

>   DIABETES MEDICATION AND LIFESTYLE CHANGES CAN HELP TREAT WEIGHT GAIN INDUCED BY ANTIPSYCHOTIC DRUGS

>   BREAST CANCER RISK VARIES SIGNIFICANTLY AMONG BRCA1 AND BRCA2 CARRIERS

JAMA REPORT (VIDEO SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   PATIENTS LIVING IN RURAL AREAS ARE LESS LIKELY TO RECEIVE ORGAN TRANSPLANTS

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 rates of organ transplantation and wait-listing in rural and urban areas. The report will be fed Tuesday, January 8, 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 14, downlink frequency: 3880 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.

Please Note: This is a double issue of JAMA. There will be no JAMA or news releases for January 16.

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, January 8, 2008
Media Advisory: To contact David A. Axelrod, M.D., M.B.A., call Jason Aldous at 603-653-1913.

RURAL PATIENTS LESS LIKELY TO RECEIVE ORGAN TRANSPLANTS

CHICAGO—Patients in small towns and isolated rural areas have lower organ transplant rates and are less likely to be wait-listed than patients in urban areas, according to a study in the January 9/16 issue of JAMA.

Organ transplantation offers the best, and often only hope for long-term survival for patients with end-stage heart, liver, and kidney disease. However, despite federal regulation and national efforts to ensure equal access to the limited pool of donated organs, previous research has demonstrated the presence of significant barriers to access to transplantation services for racial minorities, women, and patients with low socioeconomic status or poor insurance, according to background information in the article. Rural residents represent another group that may have impaired access to transplant services. Nearly 14 percent of the U.S. population lives outside major urban areas.

David A. Axelrod, M.D., M.B.A., of Dartmouth Medical School, Lebanon, N.H., and colleagues assessed the impact of rural residence on waiting list registration for heart, liver, and kidney transplant and rates of transplantation among wait-listed candidates. A total of 174,630 patients who were wait-listed and who underwent heart, liver, or kidney transplantation between 1999 and 2004 were included in the study.

The researchers found significant disparities in access to organ transplantation between rural and urban populations.

“This study demonstrates that patients living in small towns and isolated rural regions were eight percent to 15 percent less likely to be wait-listed and ten percent to 20 percent less likely to undergo heart, liver, and kidney transplantation than patients in urban environments,” the authors write.

They suggest these discrepancies may be related to differences in the burden of disease in rural environments or reduced access to entering the waiting list. And they warn that the increasing concentration of transplant services in high-volume urban centers may lead to increased access barriers for rural patients.

“Further assessment of the disease burden facing rural residents and the barriers in access to specialty care services is needed to ensure equitable access to life-saving organ transplants,” the researchers conclude.
(JAMA. 2008;299[2]:202-208. 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, January 8, 2008
Media Advisory: To contact Matthew D. Snape, F.R.A.C.P., email: matthew.snape{at}paediatrics.ox.ac.uk. To contact editorial author Lee H. Harrison, M.D., call Clare Collins at 412-624-2607.

NEWER MENINGITIS VACCINE APPEARS SAFE AND EFFECTIVE FOR INFANTS

CHICAGO— vaccine not yet licensed in the United States produces immunity against four strains of meningococcal disease and is well tolerated when administered to infants, according to a study in the January 9/16 issue of JAMA.

It is estimated that 1,400 to 2,800 cases of invasive meningococcal disease occur in the United States each year, and that ten to 14 percent of people who contract the disease will die. The U.S. Advisory Committee on Immunization Practices now advises immunization with a tetravalent vaccine (serogroups A, C, W-135, and Y) for all 11- to 18-year-olds. However, the currently licensed vaccine is poorly immunogenic in infancy, when the highest rates of disease are observed, according to background information in the article.

Matthew D. Snape, F.R.A.C.P., of the Oxford Vaccine Group, University of Oxford, England, and colleagues conducted a randomized controlled study to determine the immunogenicity of a novel tetravalent meningococcal vaccine known as MenACWY in infants. Unlike the currently licensed vaccine, MenACWY uses a natural mutant of the diphtheria toxin.

The study included 421 healthy infants in the United Kingdom and Canada who received one of three different dosing schedules of MenACWY, or a monovalent vaccine against the meningitis C serogroup. The authors determined the proportion of babies who had protective antibody levels after receiving the vaccine. They also assessed vaccine safety and reactogenicity (the capacity to produce adverse reactions).

“In this study, we have demonstrated that a primary immunization course of the novel tetravalent meningococcal glycoconjugate vaccine MenACWY was well tolerated and immunogenic for serogroups A, C, W-135, and Y when given to healthy infants at either two, three, and four months or two, four, and six months of age,” the authors write.

The study found that at least 92 percent of infants who received the two-, three-, four-month schedule had protective antibody levels to all four serogroups. For the two-, four-, six-month schedule, similar results were obtained for the C, W-135, and Y serogroups, but the proportion of infants with protective antibody levels against serogroup A was lower at 81 percent.

In the two-, four-month primary series groups, at least 84 percent had protective antibody levels to three of the four serogroups, while 60 to 66 percent of infants had protective levels against serogroup A. After a booster dose at 12 months, at least 95 percent developed protective antibody levels to three of the four serogroups, and 84 percent for serogroup A.

“In conclusion, MenACWY was well tolerated and immunogenic in the first year of life,” the authors write. “This vaccine therefore extends the immune protection provided by the monovalent MenC vaccine to serogroups A, W-135, and Y in infancy.”
(JAMA. 2008;299[2]:173-184. 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: A MULTIVALENT CONJUGATE VACCINE FOR PREVENTION OF MENINGOCOCCAL DISEASE IN INFANTS

In an accompanying editorial, Lee H. Harrison, M.D., of the Infectious Diseases Epidemology Research Unit, University of Pittsburgh, looks at progress in meningitis prevention.

“In this issue of JAMA, the report by Snape and colleagues represents a substantial advance in the vaccine prevention of meningococcal disease because it provides evidence for a well-tolerated and immunogenic tetravalent (serogroups A, C, W-135, and Y) conjugate vaccine for infants.”

“Assuming that the vaccine eventually becomes licensed, additional questions will likely be addressed postlicensure. The duration of immunity is an important issue to determine whether additional doses will need to be given between a childhood series and adolescence,” Dr. Harrison writes. “Taken together with other ongoing progress, the outlook for comprehensive global prevention of this devastating disease has never been better.”
(JAMA. 2008;299[2]:217-219. 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, January 8, 2008
Media Advisory: To contact Ren-Rong Wu, M.D., email: wurenrong2005{at}yahoo.com.cn. To contact co-author Hua Jin, M.D., call 858-552-8585, ext. 3904.

DIABETES MEDICATION AND LIFESTYLE CHANGES CAN HELP TREAT WEIGHT GAIN INDUCED BY ANTIPSYCHOTIC DRUGS

CHICAGO—Lifestyle intervention and the drug metformin are both effective against antipsychotic-induced weight gain, and treatment is most effective when the two therapies are combined, according to a study in the January 9/16 issue of JAMA.

Atypical antipsychotic (AAP) medications have been used increasingly for the management of patients with a variety of psychotic disorders and severe behavioral disturbances. But in the past decade, there has been a growing concern among clinicians and researchers that use of AAP medications may be related to potentially serious adverse metabolic effects, including weight gain, hyperlipidemia (high fat levels in the blood), and glucose intolerance. Metformin is a drug used to treat type 2 diabetes. It inhibits glucose production, is well tolerated, and prevents continual weight gain while it decreases measures of insulin resistance. Some studies find that metformin can reduce body weight in patients with type 2 diabetes and in obese people who do not have diabetes, according to background information in the article.

Ren-Rong Wu, M.D., of the Mental Health Institute of the Second Xiangya Hospital, Central South University, China, and colleagues conducted a randomized controlled trial from October 2004 to December 2006 to test the efficacy of lifestyle intervention and metformin alone and in combination for antipsychotic-induced weight gain and abnormalities in insulin sensitivity. The study included a total of 128 adult patients with schizophrenia. Participants who gained more than ten percent of their pre-drug weight were assigned to one of four treatment groups.

The patients continued their antipsychotic medication and were randomly assigned to 12 weeks of placebo, 750 milligrams per day of metformin alone, 750 milligrams per day of metformin with lifestyle intervention, or lifestyle intervention alone. Lifestyle interventions included psycho-educational, dietary, and exercise programs.

“In this 12-week study, we found statistically significant decreases in mean weight, BMI [body mass index], waist circumference, insulin, and IRI [insulin resistance index] among patients in the lifestyle-plus-metformin, metformin-alone, and lifestyle-plus-placebo groups, but not among those in the placebo-alone group whose measurements continued to increase,” the authors write.

Those taking metformin in combination with lifestyle intervention had average decreases of 1.8 in BMI, 3.6 in IRI, and two centimeters in waist circumference. Those taking metformin alone showed average decreases of 1.2 in BMI, 3.5 in IRI, and 1.3 centimeters in waist circumference. In the lifestyle-plus-placebo group, participants had average decreases of 0.5 in BMI, and 1.0 in IRI. Participants in the placebo group continued to show increases in all measures: 1.2 in BMI, 0.4 in IRI, and 2.2 centimeters in waist circumference.

“Lifestyle intervention and metformin alone and in combination demonstrated efficacy for antipsychotic-induced weight gain. Lifestyle intervention plus metformin showed the best effect on weight loss,” the authors conclude. “Metformin alone was more effective in weight loss and improving insulin sensitivity than lifestyle intervention alone.”
(JAMA. 2008;299[2]:185-193. 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, January 8, 2008
Media Advisory: To contact Colin B. Begg, Ph.D., call Jeanne D'Agostino at 646-227-3573.

BREAST CANCER RISK VARIES SIGNIFICANTLY AMONG BRCA1 AND BRCA2 CARRIERS

CHICAGO—There is a broad variation in the risk of developing breast cancer among people who carry the BRCA1 and BRCA2 gene mutation, according to a study in the January 9/16 issue of JAMA.

BRCA1 and BRCA2 are gene mutations that predispose carriers to breast cancer. The magnitude of the risk of breast cancer in BRCA1 and BRCA2 carriers is critical for guiding decisions concerning cancer prevention options. The risk of breast cancer in BRCA1 and BRCA2 mutation carriers has been examined in many studies, but relatively little attention has been paid to the degree to which the risk may vary among carriers, according to background information in the article.

Colin B. Begg, Ph.D., of Memorial Sloan-Kettering Cancer Center, New York, and colleagues conducted an investigation to determine the extent to which risks of BRCA1 and BRCA2 carriers vary with respect to observable and unobservable characteristics. Participants in the Women’s Environmental Cancer and Radiation Epidemiology (WECARE) Study, who were previously diagnosed with unilateral breast cancer (affecting only one side) or contralateral breast cancer (affecting the opposite side of an initial breast cancer), were genotyped for mutations in BRCA1 and BRCA2. All participants had their initial breast cancer diagnosed during the period from January 1985 through December 2000, before the age of 55.

“Among the 1,394 participants with unilateral breast cancer, 73 (5.2 percent) were identified as carriers of deleterious mutations (42 with BRCA1 and 31 with BRCA2),” the authors report. “Among the 704 participants with contralateral breast cancer, 108 (15.3 percent) were identified as carriers of deleterious mutations (67 with BRCA1 and 41 with BRCA2).”

Among relatives of BRCA1 and BRCA2 carriers, risk was significantly associated with a younger age at diagnosis in the proband (the family member through whom a family’s medical history comes to light). There was a trend toward higher risk for relatives of participants with contralateral breast cancer vs. unilateral breast cancer participants. “In addition, there were significant differences in risk between carrier families after adjusting for these observed characteristics,” the authors write.

Population-based screening for BRCA1 and BRCA2 mutations is not recommended at this time. But the authors point out that in the future, as technology advances and genotyping costs are reduced, widespread genetic screening for important risk factors for breast cancer and other diseases may become routine and is likely to serve as the foundation for tailored risk reduction interventions. “For this reason, accurate estimation of the risks conferred in the population and identification of important sources of variation in these risks constitute important scientific goals with significant implications for the clinical management of female carriers of BRCA1 and BRCA2 mutations,” the authors conclude.
(JAMA. 2008;299[2]:194-201. 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

PATIENTS LIVING IN RURAL AREAS ARE LESS LIKELY TO RECEIVE ORGAN TRANSPLANTS

INTRO:
More than 25 thousand people in the United States undergo organ transplants each year. But a new study finds that depending on where you live, you may be less likely to receive the organ transplant you need. Jennifer Mitchell explains in this week's JAMA Report.

VIDEO:
B-ROLL
Close up Lisa
Lisa and family talking

AUDIO:
LISA CHRONIS HAS SPENT YEARS BATTLING DIABETES AND KIDNEY DISEASE. WHEN HER KIDNEY FUNCTION FAILED, SHE KNEW AN ORGAN TRANSPLANT WOULD BE ONE OF HER FEW OPTIONS.

VIDEO:
SOT/FULL
@ :11
Super: Lisa Chronis
Rural Transplant Patient
Runs :06

AUDIO:
“It’s either dialysis or transplant or death. Those are your three options.”

VIDEO:
B-ROLL
Pictures of Lisa and husband
Rural NH shots, Lisa outside home and wide shot large field with snow
GFX/JAMA COVER

AUDIO:
LISA’S HUSBAND MARC DONATED A KIDNEY TO HER LAST YEAR. LISA LIVES IN RURAL NEW HAMPSHIRE AND HER TRANSPLANT EXPERIENCE WENT RATHER SMOOTHLY. HOWEVER, A NEW STUDY IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, FINDS THAT MANY PATIENTS LIVING IN RURAL AMERICA ARE LESS LIKELY TO RECEIVE ORGAN TRANSPLANTS THAN PATIENTS LIVING IN URBAN AREAS.

VIDEO:
SOT/FULL
@ :34
Super: David Axelrod, MD
Dartmouth-Hitchcock Medical Center
Runs :10

AUDIO:
"What we found was that patients who lived in the country were less likely to receive a heart, liver or kidney transplant compared to patients who lived in the city.”

VIDEO:
B-ROLL
Wide shot Axelrod in OR doing surgery
Tight shots of machines, surgery
Full screen graphic
Organ Transplant Study
Rural Residents
Up to 15% less likely to be wait-listed
Up to 20% less likely to undergo heart, liver and kidney transplants
Compared to Urban Residents

AUDIO:
DR. DAVID AXELROD IS A RESEARCHER AT DARTMOUTH-HITCHCOCK MEDICAL CENTER. HE AND HIS COLLEAGUES FOUND THAT PATIENTS LIVING IN ISOLATED RURAL AREAS WERE UP TO 15% LESS LIKELY TO BE PLACED ON WAITING LISTS FOR ORGAN TRANSPLANTATION AND UP TO 20% LESS LIKELY TO UNDERGO HEART, LIVER AND KIDNEY TRANSPLANTS COMPARED TO PATIENTS LIVING IN URBAN SETTINGS.

VIDEO:
SOT/FULL
David Axelrod, M.D.
Dartmouth-Hitchcock Medical Center
Runs :09

AUDIO:
“When you look at our study it suggests that the barrier to transplantation is not from within the transplant centers but it’s really the barriers to getting in the front door in the first place.”

VIDEO:
B-ROLL
Cars on road, city shots
Shots of transplant surgery

AUDIO:
TRANSPORTATION CAN BE A PROBLEM BECAUSE MOST TRANSPLANT CENTERS ARE LOCATED IN URBAN AREAS AND PATIENTS REQUIRE SEVERAL FOLLOW-UP VISITS.

VIDEO:
SOT/FULL
David Axelrod, M.D.
Dartmouth-Hitchcock Medical Center
Runs :06

AUDIO:
"We need to consider is it reasonable for someone to drive eight or ten hours on a regular basis just to have healthcare."

VIDEO:
B-ROLL
Lisa and daughters in house
Rural shots outside Lisa’s house

AUDIO:
LUCKILY - LISA CHRONIS WAS ABLE TO FIND A CENTER AN HOUR AND A HALF FROM HER HOME. NOT EXACTLY CLOSE BUT SHE KNOWS OTHERS WHO HAVE TO DRIVE EVEN FARTHER.

VIDEO:
SOT/FULL
Lisa Chronis
Rural Transplant Patient
Runs :09

AUDIO:
“I think one of the points I’d like to make is the closer you are, the more likely you are to be compliant with what is necessary.”

VIDEO:
B-ROLL
Lisa in home
Picture: Lisa and family
Ends on picture of Lisa and Husband

AUDIO:
SHE SAYS HAVING CLOSER ACCESS MEANS FAMILY MEMBERS ARE ALSO MORE LIKELY TO BE THERE WITH YOU. THAT WEIGHED HEAVILY INTO HER DECISION TO PROCEED WITH THE TRANSPLANT SHE NEEDED. THIS IS JENNIFER MITCHELL WITH THE JAMA REPORT.

TAG:
The study in JAMA looked at a national sample of transplant patients over a five year period from 1999 to 2004. Dr. Axelrod says further studies are necessary to fully understand the differences in transplant rates and the potential barriers in access to care. For more information, visit www.jama.com.

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