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, June 19, 2007)
JAMA NEWS RELEASES
SIZE OF FAMILY STRUCTURE COULD AFFECT ACCURACY OF PREDICTING BREAST CANCER RISK FOR PATIENTS UNDERGOING BRCA GENE TESTING
MEDICARE PART D PLANS VARY SUBSTANTIALLY, BUT MOST APPEAR TO COVER MANY COMMON MEDICATIONS AT LOW CO-PAYMENTS
REVIEW OF PREVIOUS STUDIES SUGGESTS MORE EFFECTIVE TREATMENT REGIMEN FOR MALARIA CONTROL DURING PREGNANCY IN AFRICA
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
CONTRARY TO CURRENT PRACTICE, MANY BREAST CANCER PATIENTS WITH NO FAMILY HISTORY OF BREAST CANCER SHOULD BE OFFERED GENETIC TESTING
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 effect of family structure on predicting breast cancer risk for patients undergoing BRCA gene testing. The report will be fed Tuesday, June 19, 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.
SAVE THE DATE: JAMA will present new research from its theme issue on Chronic Diseases of Children at a media briefing on Tuesday, June 26, from 10 a.m. – 12:15 p.m., at the Millennium Broadway Hotel in New York. Program and registration information will be included in a future email.
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Embargoed for Release: 3:00 p.m. CT, Tuesday, June 19, 2007
Media Advisory: To contact Jeffrey N. Weitzel, M.D., call Kathleen O’Neil at 800-888-5323. To contact editorial co-author Noah D. Kauff, M.D., call 212-639-3573.
SIZE OF FAMILY STRUCTURE COULD AFFECT ACCURACY OF PREDICTING BREAST CANCER RISK FOR PATIENTS UNDERGOING BRCA GENE TESTING
CHICAGO—Researchers have found that the probability of the breast cancer gene mutation BRCA among women with a history of breast cancer is greater when the number of older, female relatives in the family is smaller, according to a study in the June 20 issue of JAMA. This finding may challenge the accuracy of some breast cancer prediction models, which may not take family structure into account.
“Germline BRCA1 or BRCA2 gene mutations significantly increase a woman’s risk of breast cancer (50 percent - 85 percent) and ovarian cancer (16 percent - 50 percent),” the authors write. “Documented efficacy of screening and risk reduction interventions provides evidence for individualized risk management advice, making genetic cancer risk assessment (GCRA) a component of medically necessary care. Identifying appropriate candidates for GCRA is challenging.”
Jeffrey N. Weitzel, M.D., of the City of Hope, Duarte, Calif., and colleagues conducted a study to determine if genetic risk models underestimate the BRCA gene mutation prevalence for “single-case indicators,” that is, women with a limited family structure (less than two females who lived to age 45 or older in each lineage) who have early onset breast cancer and no family history of breast or ovarian cancers. “If true, a more accurate estimation of BRCA gene mutation probability may be needed for these women,” the researchers write.
The study included 1,543 women seen at U.S. high-risk clinics for genetic cancer risk assessment and BRCA gene testing, who were enrolled in the study between April 1997 and February 2007. Three hundred six of these women had breast cancer before age 50 years and no first- or second-degree relatives with breast or ovarian cancers.
Family structure was limited in 153 cases (50 percent). BRCA gene mutations were detected in 13.7 percent of participants with limited vs. 5.2 percent with adequate family structure. Participants with a limited family structure had an increased likelihood of being carriers of a BRCA gene mutation than those with adequate family structure.
“Although statistically intuitive, limited family structure is akin to the problem of ‘missing values’ and is a limitation of all common mutation probability models. Consequently, absent better models, cancer risk assessment practices and genetic testing guidelines need to be more inclusive of single cases of breast cancer when there is limited family structure,” the authors write. “The fact that commonly used models for estimating BRCA gene mutation probability were insensitive to family structure as a predictive factor is a cautionary note for community practitioners.”
“Given the significant effect of family structure, illustrated by limited accuracy of probability models for single cases of breast cancer, and the commonality of the missing-data problem, the databases of currently available probability models should be reanalyzed and limited family history recoded as a separate variable.”
(JAMA. 2007;297:2587-2595. 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: MODELING GENETIC RISK OF BREAST CANCER
In an accompanying editorial, Noah D. Kauff, M.D., and Kenneth Offit, M.D., M.P.H., of Memorial Sloan-Kettering Cancer Center, New York, write that the use of some genetic risk prediction models should be used cautiously.
“Weitzel and colleagues make a compelling argument that risk assessment models are likely not appropriate if only a limited number of informative relatives are available in either the maternal or paternal lineage. Perhaps more important than this specific conclusion are the implications this study has for use and interpretation of risk assessment models in general. The authors clearly demonstrate that in this cohort, several of the most commonly used risk assessment models overestimate mutation probability, and the resultant lifetime cancer risk, in the setting of adequate family structure. These same models underestimated the risk in the setting of less informative family structure.”
“Given these limitations, important questions are whether currently available models are appropriate to triage individuals for genetic testing or are adequate to provide cancer risk prediction and guidance of care in the absence of genetic testing.”
(JAMA. 2007;297:2637-2639. 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, June 19, 2007
Media Advisory: To contact Chien-Wen Tseng, M.D., M.P.H., call Brendon Shank at 202-256-2083.
MEDICARE PART D PLANS VARY SUBSTANTIALLY, BUT MOST APPEAR TO COVER MANY COMMON MEDICATIONS AT LOW CO-PAYMENTS
CHICAGO—An examination of Medicare Part D plans in California and Hawaii reveals wide variations in drug formularies, but indicates that for many classes of drugs, it is possible to find at least one or more drug that is covered by nearly all Part D plans, according to a study in the June 20 issue of JAMA.
Nearly 23 million of the 43.9 million eligible Medicare beneficiaries have enrolled in the Medicare Part D prescription drug benefit, according to background information in the article. Because of the number and variety of plans, clinicians often find it difficult to know which drugs are covered by Part D plan formularies. Previous studies indicate that two-thirds of clinicians say they lack familiarity with Part D formularies, and three-fourths have been asked by pharmacies or patients to change a prescription to a different drug so that it would be covered by the patient’s plan. The number of Part D plans is increasing, with 1,875 stand-alone prescription drug plans in 2007 compared with 1,429 in 2006. Many states have more than 50 Part D plans. “Wide formulary variation can lead clinicians to inadvertently prescribe drugs that are not covered by insurance or that require a high co-payment, increasing patients’ financial burden and decreasing medication adherence,” the authors write.
Chien-Wen Tseng, M.D., M.P.H., of the John A. Burns School of Medicine at the University of Hawaii, Honolulu, and colleagues conducted a study to determine whether Part D formularies in California (the state with the most Medicare beneficiaries) and Hawaii have at least one drug within each of eight treatment classes for hypertension, hyperlipidemia, and depression that can be identified for clinicians as “widely-covered” by the vast majority of Part D plans. The researchers used the Web site medicare.gov, from March 1-April 15, 2006, to examine 72 California and 43 Hawaii Part D formularies’ coverage of eight treatment classes (angiotensin-converting enzyme [ACE] inhibitors, angiotensin II receptor blockers [ARBs], beta-blockers, calcium channel blockers, loop diuretics, selective serotonin reuptake inhibitors, statins, and thiazide diuretics), with evaluation of how often drugs were widely covered (here defined as inclusion in 90 percent or more of formularies at co-payments of $35 or less without prior authorization).
In an analyses of 72 formularies, the researchers found that coverage for 75 specific drugs ranged from 7 percent to 100 percent of formularies and averaged 69 percent across all drugs. Formulary coverage (percentage of formularies covering each drug, averaged across all drugs within a class) was highest for thiazide diuretics (90 percent) and beta-blockers (85 percent), followed by selective serotonin reuptake inhibitors (69 percent), calcium channel blockers (66 percent), ACE inhibitors (66 percent), statins (49 percent), and ARBs (39 percent).
Overall, less than half of drugs (45 percent) were widely-covered. However, 7 of 8 treatment classes (excluding ARBs) had at least one widely covered drug. Nearly all widely-covered drugs (94 percent) were generic drugs, and three-fourths of generic drugs (73 percent) were widely-covered. On average, generic drugs were covered by 90 percent of formularies. Six percent of brand-name drugs were widely- covered. Adopting the stricter requirement of coverage to include 95 percent or more of formularies at co-payments of $15 or less did not change the study findings that 7 of 8 treatment classes had at least one widely-covered drug.
“In this study to evaluate Medicare Part D plan formulary variation, the coverage of individual drugs varied extensively, indicating the potential difficulties that clinicians can face in knowing which drugs are covered or are more affordable,” the authors write. “… a potential way to address formulary variation would be to identify, within a class, which drugs are widely covered and generally more affordable for clinicians to consider. This could substantially reduce clinicians’ administrative burden from formulary variation and lower the risk that Medicare beneficiaries are inadvertently prescribed noncovered or higher cost-sharing drugs.”
“Clinicians should also be alerted to those classes with no widely covered drugs, from which they should not prescribe without first checking formulary coverage. For example, the maximum coverage for any single ARB was 81 percent of formularies. If this type of coverage information were made available in interactive fashion via a Web site, personal digital assistant–based tool, or e-prescribing software, clinicians could use this knowledge in the clinical encounter during collaborative decision making on selecting medications.”
(JAMA. 2007;297:2596-2602. 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, June 19, 2007
Media Advisory: To contact co-author Scott J. Filler, M.D., D.T.M.H., call Lola Russell of the CDC’s Press Office at 404-639-3286.
REVIEW OF PREVIOUS STUDIES SUGGESTS MORE EFFECTIVE TREATMENT REGIMEN FOR MALARIA CONTROL DURING PREGNANCY IN AFRICA
CHICAGO—A review of previous studies indicates that two doses of a malaria preventive therapy during pregnancy provides substantial benefit to HIV-negative women in Africa, with more frequent dosing apparently necessary for HIV-positive women, according to an article in the June 20 issue of JAMA.
In malaria-endemic regions, the burden of disease is primarily in young children and pregnant women. Women are particularly vulnerable to the adverse effects of malaria during their first and second pregnancies, according to background information in the article. Approximately 50 million women living in malaria-endemic areas become pregnant each year, half in areas of sub-Saharan Africa with stable Plasmodium falciparum (a parasite that causes malaria) transmission. In these regions, strategies to control malaria during pregnancy rely on case management of malaria illness and anemia, and a variety of preventive measures that consists of insecticide-treated nets (ITNs) and intermittent preventive therapy (IPT) with the malaria drug sulfadoxine-pyrimethamine.
Feiko ter Kuile, M.D., Ph.D., of the Liverpool School of Tropical Medicine, Liverpool, England and colleagues evaluated data to assess whether increasing the frequency of IPT with sulfadoxine-pyrimethamine during pregnancy could provide a temporary respite in areas in Africa with increasing sulfadoxine-pyrimethamine resistance.
The researchers identified four trials that compared 2-dose IPT with sulfadoxine-pyrimethamine to case management or placebo in women during their first or second pregnancy. The IPT reduced the risk of placental malaria by 52 percent, the risk of low birth weight by 29 percent, and the risk of anemia by 10 percent. The effect did not vary by sulfadoxine-pyrimethamine resistance levels (range, 19 percent-26 percent).
Efficacy of IPT with sulfadoxine-pyrimethamine was lower among women using insecticide-treated nets. Three trials compared 2-dose with monthly IPT with sulfadoxine-pyrimethamine during pregnancy. Among HIV-positive women in their first or second pregnancy, monthly IPT resulted in less placental malaria and higher birth weight over the range of sulfadoxine-pyrimethamine resistance tested (8 percent-39 percent). Among HIV-negative women, there was no conclusive additional effect of monthly dosing.
“The deleterious effects of malaria during pregnancy can be substantially reduced by using IPT in pregnant women. Sulfadoxine-pyrimethamine is currently the only single-dose long-acting antimalarial drug that has ideal properties (low cost, documented safety, and ease of use) for use as an IPT during pregnancy. The current appraisal of available data on the efficacy of IPT with sulfadoxine-pyrimethamine as a function of sulfadoxine-pyrimethamine treatment responses in children provides policy makers with a clearer understanding of the value of different IPT regimens with sulfadoxine-pyrimethamine during pregnancy in the context of increasing sulfadoxine-pyrimethamine drug resistance,” the authors write.
“Reserving the use of sulfadoxine-pyrimethamine for IPT during pregnancy and for infants may reduce drug pressure and may prolong longevity of this valuable drug. Almost all countries in Africa are taking this course and have either implemented or are in the process of implementing the use of combination therapy for first-line treatment in the population, mostly with artemisinin-based [a type of antimalarial drug] combinations. This will also limit the options to monitor the degree of sulfadoxine-pyrimethamine resistance in treatment studies in children in vivo, and future studies that aim to determine the effect of sulfadoxine-pyrimethamine resistance on the efficacy of IPT with sulfadoxine-pyrimethamine during pregnancy may need to rely on molecular markers.”
(JAMA. 2007;297:2603-2616. 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
CONTRARY TO CURRENT PRACTICE, MANY BREAST CANCER PATIENTS WITH NO FAMILY HISTORY OF BREAST CANCER SHOULD BE OFFERED GENETIC TESTING
INTRO:
If you have a particular gene mutation called B-R-C-A, you are at a much higher risk for breast and ovarian cancer. Until now, doctors only tested women for this gene if they had a family history of breast cancer. But a new study says that since dads can pass this gene along to their kids, even though men don’t often get breast cancer, family history may not tell the whole story. Mavis Prall explains in this week’s JAMA Report.
VIDEO:
SOT/FULL
@ :02
Super: Michele Rakoff
Breast cancer survivor
Runs :09
AUDIO:
“I had no family history and I didn’t expect to be diagnosed with breast cancer, but I went for my first mammogram and sure enough they found a small cancer.”
VIDEO:
B-ROLL
Michele looking at family photo album in her living room
AUDIO:
...WHEN MICHELE RAKOFF (RAY-koff) WAS JUST FORTY YEARS OLD. EVEN THOUGH THAT’S YOUNG FOR BREAST CANCER, DOCTORS WOULD NOT ASSUME SHE HAD THE BREAST CANCER GENE, BECAUSE SHE DIDN’T HAVE A FAMILY HISTORY OF BREAST CANCER. BUT A NEW STUDY SAYS…
VIDEO:
SOT/FULL
@ :23
Super: Jeffrey Weitzel, M.D.
City of Hope cancer center
Runs :07
AUDIO:
“We want to be sure to offer testing to all women who had early onset breast cancer despite the lack of a family history.”
VIDEO:
B-ROLL
Dr. Weitzel and colleague at table looking at data
Cutaway of diagrams showing mapping of family
AUDIO:
DR. JEFFREY WEITZEL (WHITE-sul) AND COLLEAGUES AT CITY OF HOPE CANCER CENTER NEAR LOS ANGELES STUDIED MORE THAN 15-HUNDRED WOMEN WITH BREAST CANCER TO SEE HOW OFTEN THOSE WITH NO FAMILY HISTORY HAD THE GENETIC KIND OF CANCER. DR. WEITZEL EXPLAINS THE PROBLEM WITH RELYING ON FAMILY HISTORY:
VIDEO:
SOT/FULL
Jeffrey Weitzel, M.D.
City of Hope cancer center
Runs :12
AUDIO:
“We have a woman who’s let’s say 41 years old with a breast cancer, but her dad had only brothers, so who the heck were we ever going to see this trait coming down dad’s side of the family?”
VIDEO:
B-ROLL
Dr. Weitzel in exam room with young woman and her mother
GFX/JAMA COVER
FULL SCREEN GRAPHIC
13.7% with limited family structure had BRCA gene
5.2% with adequate family structure had BRCA gene
AUDIO:
THAT’S CALLED LIMITED FAMILY STRUCTURE, WHERE THERE AREN’T ENOUGH WOMEN TO TELL IF THE ‘B-R-C-A” BREAST CANCER GENE IS PRESENT. IN THE STUDY, PUBLISHED IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, THE RESEARCHERS FOUND THAT ALMOST 14% OF THE BREAST CANCER PATIENTS WITH LIMITED FAMILY STRUCTURE HAD THE BREAST CANCER GENE, COMPARED TO JUST OVER FIVE PERCENT OF WOMEN WITH ADEQUATE STRUCTURE, MEANING AT LEAST TWO FEMALE RELATIVES SURVIVING PAST AGE 45.
VIDEO:
SOT/FULL
Jeffrey Weitzel, M.D.
City of Hope cancer center
Runs :08
AUDIO:
“What we showed was that if you had a limited family structure, not enough women in the family to help see the trait, that you were three times more likely to be a carrier.”
VIDEO:
B-ROLL
Dr. Weitzel and colleague looking at data
Michele walking her dog outside
AUDIO:
AND THAT’S IMPORTANT BECAUSE IF DOCTORS KNOW YOU HAVE THE GENE, THEY KNOW TO TREAT THE CANCER MORE AGGRESSIVELY AND TO WATCH OUT FOR OVARIAN CANCER AS WELL. MICHELE RAKOFF HAD THE GENETIC TEST, AND DID NOT HAVE THE GENE. BUT SHE IS NOW AN ADVOCATE FOR BREAST CANCER PATIENTS.
VIDEO:
SOT/FULL
Michele Rakoff
Breast cancer survivor
Runs :10
AUDIO:
“We need to make sure that women are aware that you can get a genetic mutation through the line of your father as well as your mother.”
VIDEO:
B-ROLL
Woman having a mammogram
Lab tech performing test on vial of blood
AUDIO:
DR. WEITZEL AGREES, AND SAYS IF YOU’RE DIAGNOSED WITH BREAST CANCER UNDER AGE FIFTY, GETTING A GENETIC TEST COULD HELP SAVE YOUR LIFE. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
TAG:
Among all women with breast cancer, only one in twenty has the breast cancer gene, but among younger breast cancer patients, that percentage is higher. Women who have the gene are more likely to get a second cancer in the other breast, and more likely to get ovarian cancer. For more information, visit www.jama.com.
