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July 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, July 8, 2008)


JAMA NEWS RELEASES

>   MEDICARE MODERNIZATION ACT NOT ASSOCIATED WITH MAJOR CHANGES IN ACCESS TO CHEMOTHERAPY

>   ANDROGEN DEPRIVATION THERAPY FOR LOCALIZED PROSTATE CANCER NOT ASSOCIATED WITH IMPROVED SURVIVAL

>   ELEVATED LEVEL OF CERTAIN PROTEIN ASSOCIATED WITH INCREASED RISK FOR DIABETES

>   INDEX USED TO PREDICT ATHEROSCLEROSIS MAY IMPROVE ACCURACY OF CARDIOVASCULAR RISK PREDICTION

JAMA REPORT (VIDEO SCRIPT)

>   VIDEO: Windows Media | Quicktime

>   CHANGES TO MEDICARE AND ACCESS TO CARE FOR CANCER PATIENTS

INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.

TV Note: This week's JAMA Video News Report is on the Medicare Modernization Act and the effect on access to chemotherapy. The report will be fed Tuesday, July 8, from 9:00 - 9:30 a.m. ET and 2:00 - 2:30 p.m. ET. Please note new coordinates: Galaxy 25 (C band), Transponder 15, downlink frequency: 4000 vertical, audio 6.2/6.8. For more information, call 312/464-JAMA.

SAVE THE DATE: JAMA will present new research on HIV/AIDS at a media briefing on Sunday, August 3, at the International AIDS Conference in Mexico City. Program information will be included in a future email. To register, go to www.jamamedia.org and click on the Events tab.

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, July 8, 2008
Media Advisory: To contact corresponding author Lesley H. Curtis, Ph.D., call Michelle Gailiun at 919-660-1306.

MEDICARE MODERNIZATION ACT NOT ASSOCIATED WITH MAJOR CHANGES IN ACCESS TO CHEMOTHERAPY

CHICAGO—Despite concerns that reductions in physician reimbursements for outpatient chemotherapy related drugs as a result of the Medicare Modernization Act of 2003 would have a detrimental effect on patients requiring chemotherapy, new research indicates that there have not been major changes in travel distance and patient wait times for chemotherapy in the Medicare population since 2003, according to a study in the July 9 issue of JAMA.

In addition to establishing an outpatient prescription drug benefit for Medicare beneficiaries, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) changed physician reimbursement for chemotherapy-related drugs and administration services. Before the enactment of the MMA, Medicare reimbursement to physicians for chemotherapy drugs often exceeded acquisition costs because many physicians obtained the drugs at substantially discounted prices. In an effort to curtail this overpayment and align reimbursement more closely with market prices, the MMA reduced payments for chemotherapy drugs, according to background information in the article.

“… there was concern that the reduction in physician reimbursement would lead to closures of some private oncology practices, requiring the 80 percent of cancer patients who receive treatment in community settings to travel farther from their homes to local hospitals for treatment. Moreover, without sufficient opportunity to plan and expand their services and without financial incentive to do so, hospital-based clinics might not have adequate resources to support the anticipated rapid influx of patients seeking chemotherapy, thereby further delaying provision of care,” the authors write.

Alisa M. Shea, M.P.H., of Duke University School of Medicine, Durham, N.C., and colleagues examined patient wait times and travel distance for chemotherapy before and after the enactment of the MMA by conducting an analysis of a nationally representative 5 percent sample of claims from the Centers for Medicare & Medicaid Services for the period 2003 through 2006. Patients were Medicare beneficiaries with new breast cancer, colorectal cancer, leukemia, lung cancer, or lymphoma who received chemotherapy in inpatient hospital, institutional outpatient, or physician office settings. In this sample, there were 5,082 new cases of breast cancer, colorectal cancer, leukemia, lung cancer, or lymphoma in 2003; 5,379 cases in 2004; 5,116 cases in 2005; and 5,288 cases in 2006.

In each year, approximately 70 percent of patients had their first chemotherapy visit in a physician office, and no more than 10 percent received chemotherapy in an inpatient hospital setting. The distribution of treatment settings in 2003 was not significantly different from 2004; however, there was a small but significant difference between 2003 and 2006. The proportion of patients receiving chemotherapy in inpatient settings decreased from 10.2 percent in 2003 to 8.8 percent in 2006, and the proportion of patients in institutional outpatient settings increased from 21.1 percent to 22.5 percent. The proportion of patients in physician offices remained at 68.7 percent.

The median (midpoint) time from diagnosis to initial chemotherapy visit was 28 days in 2003, 27 days in 2004, 29 days in 2005, and 28 days in 2006. Average wait times for chemotherapy were 1.96 days longer in 2005 than in 2003 but not significantly different in 2006 (0.88 days). Median travel distance was 7 miles in 2003 and 8 miles in 2004 through 2006. After adjustment, average travel distance remained slightly longer in 2004 (1.47 miles), 2005 (1.19 miles), and 2006 (1.30 miles) compared with 2003.

“As measured by travel distance and time to chemotherapy, our findings do not support anecdotal reports that the enactment of the MMA has changed access to chemotherapy in a meaningful way. Given the slow transition to full implementation of the reimbursement changes mandated by the MMA and the limited amount of follow-up data available at present, it may be premature to observe a relationship between these changes and delivery of care. With the aging of the U.S. population, the number of elderly individuals with cancer is expected to increase proportionally, with incidence doubling in less than 30 years. As the burden increases, researchers should continue to monitor the effects of major policy changes on Medicare beneficiaries’ access to care,” the authors conclude.
(JAMA. 2008;300[2]:189-196. 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, July 8, 2008
Media Advisory: To contact corresponding author Siu-Long Yao, M.D., call Michele Fisher at 732-235-9872.

ANDROGEN DEPRIVATION THERAPY FOR LOCALIZED PROSTATE CANCER NOT ASSOCIATED WITH IMPROVED SURVIVAL

CHICAGO—A therapy that involves depriving the prostate gland the male hormone androgen is not associated with improved survival for elderly men with localized prostate cancer, compared to conservative management of the disease, according to a study in the July 9 issue of JAMA.

Prostate cancer is the most common nonskin cancer and the second most common cause of cancer death among men. “For the majority of men with incident prostate cancer (approximately 85 percent), disease is diagnosed at localized (T1-T2) stages, and standard treatment options include surgery, radiation, or conservative management (i.e., deferral of treatment until necessitated by disease signs or symptoms). Although not standard or sanctioned by major groups or guidelines, an increasing number of clinicians and patients have turned to primary androgen deprivation therapy (PADT) as an alternative to surgery, radiation, or conservative management, especially among older men,” the authors write. In a 1999-2001 survey, PADT had become the second most common treatment approach, after surgery, for localized prostate cancer, despite a lack of data regarding PADT’s efficacy.

Grace L. Lu-Yao, M.P.H., Ph.D., of the Cancer Institute of New Jersey, UMDNJ-Robert Wood Johnson Medical School, Piscataway, N.J., and colleagues assessed the association between PADT and disease-specific survival and overall survival in 19,271 men with T1-T2 (localized) prostate cancer (diagnosed in 1992 – 2002). The patients, age 66 years or older, did not receive definitive local therapy (i.e., such as prostatectomy) for prostate cancer. Among the patients, 7,867 (41 percent) received PADT, and 11,404 were treated with conservative management, not including PADT. During the follow-up period (through December 2006 for all-cause mortality and through December 2004 for prostate cancer–specific mortality) there were 1,560 prostate cancer deaths and 11,045 deaths from all causes.

The researchers found that use of PADT for localized prostate cancer was associated with lower 10-year prostate cancer–specific survival (80.1 percent vs. 82.6 percent) and no increase in 10-year overall survival compared with conservative management. However, in a prespecified subset analysis, PADT use in men with poorly differentiated cancer was associated with improved 10-year prostate cancer–specific survival (59.8 percent vs. 54.3 percent) but not overall survival (17.3 percent vs. 15.3 percent).

“The significant adverse effects and costs associated with PADT, along with our finding of a lack of overall survival benefit, suggest that clinicians should carefully consider the rationale for initiating PADT in elderly patients with T1-T2 prostate cancer,” the authors conclude.
(JAMA. 2008;300[2]:173-181. 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, July 8, 2008
Media Advisory: To contact Joachim H. Ix, M.D., M.A.S., call Debra Kain at 619-543-6163.

ELEVATED LEVEL OF CERTAIN PROTEIN ASSOCIATED WITH INCREASED RISK FOR DIABETES

CHICAGO—Having a higher than normal level of fetuin-A, a protein produced in the liver and secreted into the blood stream, is associated with an increased risk of the development of diabetes, according to a study in the July 9 issue of JAMA.

“Type 2 diabetes mellitus has become a global epidemic and the increased prevalence of obesity is a major contributing factor. However, diabetes does not develop in all obese individuals and there is a strong genetic contribution to risk. Despite significant recent advances, mechanisms responsible for individual differences in clinical phenotype remain largely unknown,” the authors write. Previous studies have found an association between higher fetuin-A levels and insulin resistance, but the association with incident type 2 diabetes mellitus is unknown.

Joachim H. Ix, M.D., M.A.S., of the University of California, San Diego, and San Diego Veterans Affairs Healthcare System, and colleagues conducted a study to examine whether higher fetuin-A levels are associated with the occurrence of diabetes in older persons. The study included 406 persons (age 70 to 79 years) without diabetes at the start of the study, and who had fetuin-A levels measured at baseline, and had six years of follow-up. Diabetes developed in 135 participants (10.1 cases/1,000 person-years [the number of individuals in the study times the number of years of follow-up per person]).

Analysis indicated a graded increase in the incidence of diabetes with increased fetuin-A levels. The third of the group with the highest levels had more than twice the incidence rate compared with the lowest third (13.3 vs. 6.5 cases/1,000 person-years). The association was independent of physical activity, inflammatory biomarkers, and other commonly available measures of insulin resistance and was irrespective of sex, race, and obesity status. The association was moderately weakened by adjustment for visceral adiposity (fat accumulation around the abdomen).

“Future studies should evaluate whether the results may generalize to middle-aged individuals in whom the [diabetes] incidence rate is highest. If confirmed in future studies, fetuin-A may ultimately prove useful as a target for therapeutics, and its study may provide novel insights to glucose metabolism in humans,” the authors conclude.
(JAMA. 2008;300[2]:182-188. 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, July 8, 2008
Media Advisory: To contact Gerry Fowkes, Ph.D., email: gerry.fowkes{at}ed.ac.uk.

INDEX USED TO PREDICT ATHEROSCLEROSIS MAY IMPROVE ACCURACY OF CARDIOVASCULAR RISK PREDICTION

CHICAGO—The ankle brachial index, a ratio of blood pressure measurements used to indicate the risk of peripheral artery disease and atherosclerosis, may be useful to improve the accuracy of cardiovascular risk prediction, according to a meta-analysis of previous studies, reported in the July 9 issue of JAMA.

Major cardiovascular and cerebrovascular events including heart attack and stroke often occur in individuals without known pre-existing cardiovascular disease. The prevention of such events, including the accurate identification of those at risk, remains a serious public health challenge. Scoring equations to predict those at increased risk have been developed using cardiovascular risk factors, including cigarette smoking, blood pressure, total and high-density lipoprotein cholesterol, and diabetes mellitus, according to background information in the article. The Framingham risk score (FRS) is often considered the reference standard but has limited accuracy, tending to overestimate risk in low-risk populations and underestimate risk in high-risk populations.

Attention has been given to indicators of asymptomatic atherosclerosis, such as coronary artery calcium and the ankle brachial index (ABI), which is the ratio of systolic pressure at the ankle to that in the arm. It “is quick and easy to measure and has been used for many years in vascular practice to confirm the diagnosis and assess the severity of peripheral artery disease in the legs,” the authors write.

Gerry Fowkes, Ph.D., of the University of Edinburgh, Scotland, and colleagues with the Ankle Brachial Index Collaboration, conducted an analysis of data from 16 studies to determine if the ABI provides information on the risk of cardiovascular events and death independently of the FRS and can improve risk prediction. The studies included a total of 24,955 men and 23,339 women who had ABI measured at baseline and were followed up to detect total and cardiovascular mortality.

The researchers found that the 10-year cardiovascular mortality in men with a low ABI (0.90 or less) was 18.7 percent and with normal ABI (1.11 - 1.40) was 4.4 percent, about a four times higher risk of cardiovascular death for men with low ABI. Corresponding mortalities in women were 12.6 percent and 4.1 percent. The risks remained elevated after adjusting for FRS (2.9 for men vs. 3.0 for women). A low ABI (0.90 or less) was associated with approximately twice the 10-year total mortality, cardiovascular mortality, and major coronary event rate compared with the overall rate in each FRS category. Inclusion of the ABI in cardiovascular risk stratification using the FRS would result in reclassification of the risk category and modification of treatment recommendations in approximately 19 percent of men and 36 percent of women.

“These changes [for men] from higher to lower categories of risk would likely have an effect on decisions to commence preventive treatment, such as lipid-lowering therapy…,” the authors write. “In contrast, the main effect in women of inclusion of the ABI would be that many at low risk with the FRS (less than 10 percent) would change to a higher risk level.”

“The ABI is potentially a useful tool for prediction of cardiovascular risk. In contrast to measurement of coronary artery calcium and carotid intima media thickness, it has the advantage of ease of use in the primary care physician’s office and in community settings,” they write. The researchers add that the equipment is inexpensive, the procedure is simple, and can be performed by a suitably trained nurse or other health care professional.

“The results of our study indicate that, when using the FRS, this [considering ABI for the purposes of cardiovascular risk assessment] may indeed be justified to improve prediction of cardiovascular risk and provision of advice on ways to reduce that risk. A new risk equation incorporating the ABI and relevant Framingham risk variables could more accurately predict risk and our intention is to develop and validate such a model in our combined data set,” the authors conclude.
(JAMA. 2008;300[2]:197-208. 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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JAMA REPORTS

VIDEO: Windows Media | Quicktime

CHANGES TO MEDICARE AND ACCESS TO CARE FOR CANCER PATIENTS

INTRO:
The Medicare Modernization Act of 2003 changed the way physicians are reimbursed for chemotherapy drugs. Reimbursement payments have been reduced to more closely reflect the actual cost physicians pay for the drugs. There was concern among some patient advocate groups that this change would negatively impact access to care for Medicare patients. But a recent study finds cancer patients appear to be receiving comparable care. Jennifer Mitchell explains in this week’s JAMA Report.

VIDEO:
B-ROLL
Patient getting chemo
Patient in hospital bed
Chemo drugs
Nurse hangs chemo drugs

AUDIO:
FINDING TREATMENT CLOSE TO HOME IS IDEAL, ESPECIALLY FOR CANCER PATIENTS RECEIVING CHEMOTHERAPY. THE MEDICARE MODERNIZATION ACT OF 2003 REDUCED THE AMOUNT OF MONEY DOCTORS ARE REIMBURSED FOR CHEMO DRUGS. THERE WAS CONCERN PATIENTS WOULD PAY THE PRICE IF PRIVATE ONCOLOGY OFFICES NEEDED TO CLOSE.

VIDEO:
SOT/FULL
Super @:20
Lesley Curtis, Ph.D.
Duke University Medical Center
Runs: 11

AUDIO:
“There were a lot of concerns when the Medicare Modernization Act was passed that this would really have an adverse effect on access to cancer care for patients who are undergoing chemotherapy.”

VIDEO:
B-ROLL
Dr. Curtis walking
Doctor at desk

Graphic
Medicare Study (title)
20,000 Medicare claims
Chemotherapy wait time
Travel distance
Patient having chemo treatment

AUDIO:
DOCTOR LESLEY CURTIS WITH DUKE UNIVERSITY MEDICAL CENTER LED A TEAM OF RESEARCHERS WHO ANALYZED ABOUT TWENTY THOUSAND MEDICARE CLAIMS FROM 2003 TO 2006. RESEARCHERS LOOKED AT HOW LONG PATIENTS WAITED FOR THEIR FIRST CHEMO TREATMENT AFTER DIAGNOSIS AND HOW FAR THEY HAD TO TRAVEL FOR CARE. THEY COMPARED DATA FROM BEFORE REIMBURSEMENT CHANGES TOOK EFFECT TO AFTER.

VIDEO:
SOT/FULL
Lesley Curtis, Ph.D.
Duke University Medical Center
Runs: 06

AUDIO:
“What we found is that at least by these two measures patients have not been adversely affected and that’s that’s really good news.”

VIDEO:
B-ROLL
Patient in chemo session
Researchers
Patient in room

AUDIO:
IN 2003, PATIENTS ON AVERAGE WAITED TWENTY-EIGHT DAYS FOR THEIR FIRST CHEMO SESSION AND TRAVELED ABOUT SEVEN MILES FOR CARE. RESEARCHERS FOUND IN 2006 AVERAGE WAIT TIMES REMAINED THE SAME AND TRAVEL DISTANCE HAD ONLY INCREASED BY ABOUT ONE MILE.

VIDEO:
SOT/FULL
Super @ 1:16
Amy Abernethy, M.D.
Oncologist, Duke University Medical Center
Runs: 08

AUDIO:
“Patients are getting care as close to home as before and also they’re getting care as soon as they were prior to the legislation.”

VIDEO:
B-ROLL
GXF/JAMA COVER

AUDIO:
THE STUDY APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.

VIDEO:
SOT/FULL
Lesley Curtis, Ph.D.
Duke University Medical Center
Runs:07

AUDIO:
“What’s not clear is whether or not this sort of minimal no change that we’re seeing now, will persist over time.”

VIDEO:
B-ROLL
Two shot with nurse
Patient tight
Tight machine
Wide shot of room

AUDIO:
RESEARCHERS SAY AS MORE PEOPLE ARE DIAGNOSED WITH CANCER IT WILL BE IMPORTANT TO CONTINUE TO MONITOR MAJOR POLICY CHANGES TO MEDICARE TO ENSURE THAT PATIENTS ARE ABLE TO RECEIVE THE CARE THEY NEED CLOSE TO HOME AND WITHOUT DELAY. JENNIFER MITCHELL THE JAMA REPORT.

TAG:
Researchers found the number of patients receiving chemotherapy in an outpatient setting actually increased slightly from 2003 to 2006. The proportion of patients receiving chemo in physician offices remained the same, at about sixty-nine percent. For more information about this study you can log on to www.jama.com.

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