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 22, 2008)
JAMA NEWS RELEASES
DRUG-RELEASING STENT SHOWS PROMISE FOR IMPROVING OUTCOMES IN PATIENTS WITH CORONARY ARTERY DISEASE
NOT UNDERSTANDING MEDICARE PART D STILL AN ISSUE; MEDICATION ADHERENCE MAY BE IMPROVING OVERALL
PARTICULAR EXPERIMENTAL THERAPY NOT MORE EFFECTIVE THAN STANDARD TREATMENT FOR ANAL CANAL CANCER
JAMA REPORT (VIDEO SCRIPT)
VIDEO: Windows Media | Quicktime
SOME PATIENTS NOT ABLE TO AFFORD PRESCRIPTIONS DESPITE ENROLLING IN MEDICARE PART D PROGRAM
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 cost-related medication nonadherence following the implementation of Medicare Part D. The report will be fed Tuesday, April 22, 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: Because JAMA does not publish on the 5th Wednesday of a month, there will be no JAMA or news releases for April 30.
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 22, 2008
Media Advisory: To contact Gregg W. Stone, M.D., call Alex Lyda at 212-305-0820. To contact editorial co-author Manesh R. Patel, M.D., call Debbe Geiger at 919-660-9461.
DRUG-RELEASING STENT SHOWS PROMISE FOR IMPROVING OUTCOMES IN PATIENTS WITH CORONARY ARTERY DISEASE
CHICAGO—For patients who underwent angioplasty to open narrowed coronary arteries, the use of stents releasing the drug everolimus reduced the rate of renarrowing of the arteries and significantly reduced the risk of major cardiac events, compared to the widely-used paclitaxel-releasing stents, according to a study in the April 23/30 issue of JAMA.
Stents releasing the drugs paclitaxel and sirolimus have been shown to improve long-term event-free survival compared with bare-metal stents. However, restenosis (renarrowing of a coronary artery after angioplasty) still occurs, and the incidence of stent thrombosis (the formation or presence of a blood clot in a blood vessel), especially after the first year of implantation, is increased with these drug-releasing stents compared with their bare-metal counterparts, according to background information in the article. Newer drug-releasing stents are being designed with the goal of enhanced safety, efficacy, or both. Everolimus-releasing stents have shown favorable results in preliminary studies in improving clinical and angiographic (radiographic visualization of the blood vessels) outcomes in patients with coronary artery disease.
Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, and colleagues conducted the SPIRIT III trial to evaluate the everolimus-releasing stent in comparison to the paclitaxel-releasing stent in 1,002 patients with coronary artery disease. Patients were randomized 2:1 to receive the everolimus-releasing stent (n = 669) or the paclitaxel-releasing stent (n = 333). Angiographic follow-up was prespecified at 8 months in 564 patients and completed in 436 patients. Clinical follow-up was performed at 1, 6, 9, and 12 months.
The researchers found that angiographic in-segment late loss (a measure of restenosis) was significantly less in the everolimus-releasing stent group compared with the paclitaxel group. At 9 months, everolimus stents, compared with paclitaxel stents, were noninferior for the outcome of target vessel failure (47 of 657 patients [7.2 percent] vs. 29 of 321 [9.0 percent], respectively. Use of the everolimus stent compared with the paclitaxel stent resulted in a 44 percent reduction (4.6 percent vs. 8.1 percent) at 9 months in the composite of major adverse cardiac events (cardiac death, heart attack, or target vessel revascularization [repeat procedure to unblock a blood vessel]), and a 42 percent reduction in the composite of major adverse cardiac events at 1 year (6.0 percent vs. 10.3 percent). This was due to fewer heart attacks and target lesion revascularization procedures.
“This large-scale, prospective, randomized, single-blind, controlled study demonstrates that an everolimus-eluting stent compared with a widely used paclitaxel-eluting stent results in a significant reduction in angiographic in-segment late loss at 8 months, with noninferior 9-month rates of ischemia-driven target vessel failure,” the authors write.
(JAMA. 2008;299[16]:1903-1913. 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: NEXT-GENERATION DRUG-ELUTING STENTS — A SPIRITED STEP FORWARD OR MORE OF THE SAME
In an accompanying editorial, Manesh R. Patel, M.D., of Duke University, Durham, N.C., and David R. Holmes, Jr., M.D., of Mayo Clinic, Rochester, Minn., write that the results of the SPIRIT III trial are promising.
“These data are encouraging and would qualify as demonstrating biological plausibility and mechanistic effect at the level of a phase 2 study,” they write. “What happens next with the everolimus-eluting stent is critical. The current data from the SPIRIT III trial are analogous to the initial comparisons of drug-eluting vs. bare-metal stents. Restenosis is reduced with the everolimus stent, potentially with a clinical reduction in target lesion revascularization and myocardial infarction [heart attack]. The clinical effect in a broad population of patients who may be clinically exposed following device approval is unknown. Furthermore, clinical efficacy without any mandated angiographic analysis and long-term safety remain important unanswered clinical issues. Postmarketing approval registries, although complex and expensive to perform optimally, may not address both these concerns.”
“Physicians must continue to be judicious stewards of the interventional toolbox so that patients continue to allow them the privilege of performing procedures intended to improve their health.”
(JAMA. 2008;299[16]:1952-1953. 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.
Go back to the top.
Embargoed for Release: 3:00 p.m. CT, Tuesday, April 22, 2008
Media Advisory: To contact Jeanne M. Madden, Ph.D., call David Cameron at 617-432-0441. To contact John Hsu, M.D., M.B.A., M.S.C.E., call Maureen McInaney-Jones at 510-891-3173. To contact editorial co-author Dana P. Goldman, Ph.D., call Warren Robak at 310-451-6913.
NOT UNDERSTANDING MEDICARE PART D STILL AN ISSUE; MEDICATION ADHERENCE MAY BE IMPROVING OVERALL
CHICAGO—There still appears to be some lack of knowledge regarding Medicare’s Part D prescription drug program, although there is evidence that cost-related medication nonadherence may have improved overall, according to two studies in the April 23/30 issue of JAMA.
Before implementation of the Medicare Prescription Drug Improvement and Modernization Act, which was passed by Congress in 2003, millions of individuals who were elderly and disabled had insufficient or no insurance coverage for outpatient medications. “In the face of these economic barriers, several large surveys in the United States have shown that older individuals have resorted to behaviors such as skipping doses, reducing doses, and letting prescriptions go unfilled. Such cost-related medication nonadherence (CRN) is associated with increased risk of myocardial infarction, stroke, and preventable hospitalization,” the authors of the first study write. Since January 2006, Medicare beneficiaries have been able to purchase a prescription drug benefit (Part D), subsidized by Medicare and available through private plans. The impact of Medicare Part D on CRN is unknown.
Jeanne M. Madden, Ph.D., of Harvard Medical School and Harvard Pilgrim Health Care, Boston, and colleagues examined the changes in the prevalences of CRN and spending less on basic needs (such as food) to afford medicines, before and after Part D implementation. The study included information from the Medicare Current Beneficiary Survey (MCBS), in which 24,234 nationally representative, community-dwelling Medicare enrollees were questioned in 2004, 2005, and 2006 (response rate, 72.3 percent).
The researchers found that there was a larger absolute decrease in CRN following Medicare Part D implementation (from 14.1 percent in 2005 to 11.5 percent in 2006) than occurred between 2004 and 2005 (15.2 percent to 14.1 percent, respectively). However, no significant changes in CRN were observed among beneficiaries with fair-to-poor health, despite high baseline CRN prevalence for this group (22.2 percent in 2005) and significant decreases among beneficiaries with good-to-excellent health.
“Overall, our findings suggest that that the intensive medicine needs and financial barriers to access among the sickest beneficiaries may not have been fully addressed by Part D,” the authors write.
There were modest and significant decreases in CRN among lower-income beneficiaries, controlling for changes from 2004 to 2005, but not for higher-income beneficiaries. Significant reductions in spending less on basic needs were observed in both groups (fair-to-poor health; good-to-excellent health).
“In conclusion, we found small but significant population-level decreases in CRN and spending less on basic needs to afford medicines, nearly a year after an unprecedented shift in Medicare policy—the implementation of the Part D drug benefit. Those beneficiaries in poor health or with multiple morbidities who had substantially higher baseline CRN did not experience decreases in CRN associated with Part D implementation, although they did report reductions in spending less on basic needs. Further research is needed to determine which specific aspects of Part D did or did not alleviate the persistent burden of medication costs. Part D claims data, linked to detailed Part D plan characteristics, must be made available to study the impact of the new Medicare drug benefit on actual utilization of medications and health outcomes,” the researchers conclude.
(JAMA. 2008;299[16]:1922-1928. 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.
LIMITED KNOWLEDGE OF COST-SHARING REQUIREMENTS OF MEDICARE PART D MAY EFFECT DRUG ADHERENCE
Enrollees in the large Medicare Advantage Part D drug plan have a limited knowledge of the plan’s cost-sharing requirements, and more than one-third report cost-coping behaviors such as reducing drug adherence or switching to a cheaper drug, according to a study in the April 23/30 issue of JAMA.
In comparison with commercial insurance, Part D benefits use complex and high levels of cost sharing to help limit drug costs, including a coverage gap that in 2006 started at $2,250 in total drug costs and ended after $3,600 of beneficiary out-of-pocket spending. “In 2006, 85 percent of stand-alone prescription drug plans and 72 percent of Medicare Advantage Prescription Drug plans included a coverage gap, meaning that beneficiaries were responsible for all of their drug costs during the gap. In addition, 91 percent of stand-alone prescription drug plans and 93 percent of Medicare Advantage Prescription Drug plans in 2006 had tiered cost sharing prior to the coverage gap, under which beneficiaries paid more for higher-tier drugs such as brand-name medications. Failure to understand these complex benefit structures may limit beneficiaries’ abilities to anticipate or manage their medication costs,” the authors write.
John Hsu, M.D., M.B.A., M.S.C.E., of Kaiser Permanente Medical Care Program, Oakland, Calif., and colleagues investigated beneficiaries’ knowledge of their Part D benefit structures, including their awareness of the coverage gap, after their first full year in the program, and cost responses. Telephone interviews were conducted in 2007 in a random sample of community-dwelling Kaiser Permanente-Northern California Medicare Advantage beneficiaries age 65 years or older, with a gap in coverage if they exceeded $2,250 in drug costs (n = 1,040; 74.9 percent response rate). A range of self-reported responses to drug costs was examined, including decreased adherence to prescribed drug use, use of other cost-coping behaviors (such as switching to lower-cost medications), and reports of financial burden (such as going without necessities).
An estimated 40 percent of beneficiaries knew that their drug plan included a coverage gap. Awareness of the gap increased with 2006 drug costs. Approximately 36 percent of beneficiaries reported changing their behavior because of costs; 26 percent reported any cost-coping behavior; 15 percent reported decreasing adherence; and 7 percent reported experiencing financial burdens. The most frequently reported cost-coping behavior was switching to a cheaper drug (15 percent). Among adherence changes, the most frequently reported behavior was not refilling a prescription (8 percent).
In further analyses, beneficiaries with lower household income more frequently reported cost responses. Compared with beneficiaries who were unaware of having a coverage gap, those who were aware more frequently reported any cost response, but had fewer reports of borrowing money or going without necessities.
“...the low levels of knowledge found in this study reinforce the need for both improved education and tools for Part D beneficiaries. Lack of knowledge or [lack of planning] could limit potential intended cost-sharing effects of encouraging more judicious resource use. Lack of awareness also may limit beneficiaries’ ability to avoid higher drug costs. Increased efforts by Medicare and health plans to educate beneficiaries on the details of their Part D cost-sharing structures and levels are needed,” the authors write.
(JAMA. 2008;299[16]:1929-1936. 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: MEDICARE PART D — A SUCCESSFUL START WITH ROOM FOR IMPROVEMENT
In an accompanying editorial, Dana P. Goldman, Ph.D., of the RAND Corporation, Santa Monica, Calif., and the National Bureau of Economic Research, Cambridge, Mass., and Geoffrey F. Joyce, Ph.D., of the RAND Corporation, comment on the studies in this week’s JAMA regarding Medicare Part D.
“The primary objective of the Medicare Modernization Act was to provide seniors with affordable coverage for their prescription medications. This goal has been largely achieved, as more than 90 percent of Medicare beneficiaries now have prescription drug coverage at least as generous as the Standard Part D benefit. The fact that average premiums are substantially lower than initial projections provides some evidence that the market is working. The articles by Hsu et al and by Madden et al document beneficiary confusion and problems with adherence—issues that are not likely to be endemic but still must be monitored. It may be that some features of the Part D benefit, especially the dreaded doughnut hole [the gap in the standard benefit under Part D], are ripe for redesign.”
(JAMA. 2008;299[16]:1954-1955. 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.
Go back to the top.
Embargoed for Release: 3:00 p.m. CT, Tuesday, April 22, 2008
Media Advisory: To contact Jaffer A. Ajani, M.D., call Laura Sussman at 713-745-2457.
PARTICULAR EXPERIMENTAL THERAPY NOT MORE EFFECTIVE THAN STANDARD TREATMENT FOR ANAL CANAL CANCER
CHICAGO—Use of chemotherapy with the drug cisplatin before other treatments did not improve disease-free survival for patients with anal canal cancer compared to the standard treatment regimen, and resulted in a higher rate of colostomy procedures, according to a study in the April 23/30 issue of JAMA.
Chemoradiation is the preferred primary therapy for patients with anal canal cancer; however, the 5-year disease-free survival rate from concurrent fluorouracil/mitomycin (anti-cancer drugs) and radiation is only approximately 65 percent. It has been suggested that reducing the cancer in the primary tumor and in the lymph node(s) prior to administration of chemoradiation could potentially be effective for treating anal canal cancer. It was hypothesized for this study that disease-free survival might be improved by administering induction chemotherapy (use of chemotherapy as initial treatment before surgery or radiotherapy of a malignancy) with the anti-cancer drug cisplatin, to down-stage or downsize the cancer prior to concurrent chemoradiation. Pilot studies with this therapy had encouraging results.
Jaffer A. Ajani, M.D., of the University of Texas M. D. Anderson Cancer Center, Houston, and colleagues conducted a randomized controlled trial comparing treatment with fluorouracil plus mitomycin and radiotherapy vs. treatment with fluorouracil plus cisplatin and radiotherapy in 682 patients with anal canal cancer. A total of 644 patients were included in the analysis. The median (midpoint) follow-up for all patients was 2.51 years.
The 5-year disease-free survival rate was 60 percent in the mitomycin-based group and 54 percent in the cisplatin-based group. The 5-year overall survival rate was 75 percent in the mitomycin-based group and 70 percent in the cisplatin-based group, with more cancer-related deaths in the cisplatin-based group (54 patients) compared with the mitomycin-based group (28 patients).
The 5-year local-regional recurrence and distant metastasis rates were 25 percent and 15 percent, respectively, for mitomycin-based treatment and 33 percent and 19 percent, respectively, for cisplatin-based treatment. Severe hematologic (blood) toxicity was worse with mitomycin-based treatment.
Cisplatin-based treatment resulted in significantly higher cumulative rates of colostomy (19 percent vs. 10 percent; surgery to create an alternative exit from the colon created to divert waste through a hole in the colon and through the wall of the abdomen) and should generally be avoided in this patient population as primary therapy, the authors write.
“The question remains how to further improve disease-free and colostomy-free survival relative to the continued standard of concurrent chemoradiation with fluorouracil and mitomycin. ...Options to explore include targeted agents (e.g., results with concurrent cetuximab plus radiation for head/neck cancer), dose escalation with intensity-modulated radiation plus concurrent chemotherapy, and surgical excision of residual cancer after concurrent chemoradiation at an earlier interval, when sphincter preservation may still be feasible in select patients.”
(JAMA. 2008;299[16]:1914-1921. 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.
Go back to the top.
JAMA REPORTS
VIDEO: Windows Media | Quicktime
SOME PATIENTS NOT ABLE TO AFFORD PRESCRIPTIONS DESPITE ENROLLING IN MEDICARE PART D PROGRAM
INTRO:
Medicare’s prescription drug program known as Medicare Part D went into effect in 2006. It was meant to help increase economic access to prescription drugs especially for the poor and chronically ill. A new study reveals the program is helping many people however some of the most seriously ill still cannot afford the medicine they need. Jennifer Mitchell explains in this week’s JAMA Report.
VIDEO:
B-ROLL
Patient walks in kitchen
Graphic Effect: calendar in center of screen. turn months to July
AUDIO:
SIXTY-SEVEN YEAR OLD LARRY BREWER SUFFERS FROM A NUMBER OF CHRONIC ILLNESSES. A HEART CONDITION, DEPRESSION AND HIGH BLOOD PRESSURE JUST TO NAME A FEW. BY THE TIME JULY ROLLS AROUND HE SAYS HE HAS RUN OUT OF HIS MEDICARE PART D BENEFITS
VIDEO:
SOT/FULL
Super @: 16
Larry Brewer
Enrolled in Medicare Part D
Runs :07
AUDIO:
“At that point I start really cutting back on my prescriptions. There’s some I won’t even take.”
VIDEO:
B-ROLL
Doctor walks
Tight study on table
Elderly people
Pills pour on to table
AUDIO:
DOCTOR JEANNE (Jean) MADDEN AND HER COLLEAGUES AT HARVARD MEDICAL SCHOOL ANALYZED DATA FROM ANNUAL MEDICARE SURVEYS FROM 2004 THROUGH 2006. THE POSITIVE TREND THEY FOUND IS THAT MANY BENEFICIARIES NO LONGER CUT BACK ON ESSENTIAL NEEDS IN ORDER TO AFFORD MEDICATION NOW THAT MEDICARE PART D IS IN PLACE.
VIDEO:
SOT/FULL
Super @ :44
Jeanne Madden, Ph.D.
Harvard Medical School
Runs: 07
AUDIO:
“Across all groups that we saw that rate go down about forty percent compared to what it had been before Part D began.”
VIDEO:
B-ROLL
Larry at table
Opens prescription bottles
Pills and bottles
AUDIO:
BUT FOR OTHERS LIKE LARRY BREWER WHO RELIES ON AT LEAST TWELVE EXPENSIVE MEDICATIONS RESEARCHERS FOUND SKIPPING PILLS AND REDUCING PRESCRIBED DOSES IS STILL A COMMON PROBLEM.
VIDEO:
SOT/FULL
Jeanne Madden, Ph.D.
Harvard Medical School
Runs:07
AUDIO:
“We found that the sickest beneficiaries actually showed no improvement after Part D began on the measure of pill skipping due to high costs.”
VIDEO:
B-ROLL
GFX/ JAMA COVER
Bills and pills
Larry takes pill
Counting out money
AUDIO:
THE STUDY APPEARS THIS WEEK IN JAMA, JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION. RESEARCHERS SAY SUBSTANTIAL COPAYMENTS AND HAVING TO COVER FULL COSTS AFTER THE FIRST TWENTY-TWO HUNDRED AND FIFTY DOLLARS IN DRUG BENEFITS CONTRIBUTES TO THE CONTINUING HARDSHIP. LARRY BREWER PAID SEVEN HUNDRED DOLLARS A MONTH LAST YEAR AFTER HIS BENEFITS RAN OUT.
VIDEO:
SOT/FULL
Larry Brewer
Enrolled in Medicare Part D
Runs: 10
AUDIO:
“You talk about seven hundred a month. Just think if I was taking all my prescriptions the way I was supposed to. It would chew up most of my social security.”
VIDEO:
SOT/FULL
Jeanne Madden, Ph.D.
Harvard Medical School
Runs: 07
AUDIO:
“There are some features that do concentrate the burden of high costs on sicker people.”
VIDEO:
B-ROLL
Patient walking dog
Pills
AUDIO:
LARRY SAYS MEDICARE PART D DOES HELP TO SOME EXTENT. BUT FOR HIM IT LEAVES A LOT TO BE DESIRED. HE SAYS THIS SUMMER HE WILL BE IN THE SAME DIFFICULT SITUATION AGAIN. JENNIFER MITCHELL, THE JAMA REPORT.
TAG:
Researchers say about ten percent of Medicare beneficiaries including about three million low-income individuals still have no drug coverage. They say Congress needs to release Part D drug benefit data in order for further studies to determine which aspects of the program alleviate financial burden and which do not. For more information about this study you can log on to www.jama.com.
