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.

JAMA NEWS RELEASES
(Embargoed for Release: 3 p.m. CT, Tuesday, March 15, 2005)

JAMA NEWS RELEASES

   DRUG THERAPY MAY BE COMPARABLE TO INVASIVE CARDIAC PROCEDURES FOR ELDERLY PATIENTS WITH HEART ATTACK

   STUDY INDICATES THAT VITAMIN E DOES NOT PREVENT CANCER OR MAJOR CARDIOVASCULAR EVENTS, BUT MAY INCREASE RISK FOR HEART FAILURE

   USE OF POTENTIALLY INAPPROPRIATE MEDICATIONS AMONG ELDERLY INDIVIDUALS COMMON IN SOME EUROPEAN COUNTRIES

   MOST HOSPITAL EXECUTIVES HAVE SUBSTANTIAL CONCERNS ABOUT MANDATORY ERROR REPORTING SYSTEMS

JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)

   DAILY VITAMIN E LINKED TO INCREASED RISK OF HEART FAILURE

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

TV Note: This week's JAMA video news release is on the effects of long-term vitamin E supplementation on cardiovascular events and cancer. The release will be fed Tuesday, March 15, from 9:00 - 9:30 a.m. ET on Intelsat America 6 (formerly Telstar 6), Transponder 11 (C-Band) and from 2:00 - 2:30 p.m. ET on Intelsat America 6, Transponder 11 (C-Band). For more information, call 312/464-JAMA (5262).

JOURNALISTS CAN NOW ACCESS EMBARGOED JAMA/ARCHIVES STUDIES ONLINE

Go to www.jamamedia.org for more information and to apply for access.

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

Embargoed for Release: 3 p.m. CT, TUESDAY, March 15, 2005
Media Advisory: To contact Therese A. Stukel, Ph.D., call Julie Argles at 416-480-4780. To contact commentary corresponding author Harlan M. Krumholz, M.D., call Karen Peart at 203-432-1326.

CHICAGO—Although the type and intensity of treatment for acute myocardial infarction (AMI) [heart attack] varies widely across the country, elderly patients who receive intensive medical treatment may have comparable survival as those who undergo invasive cardiac procedures (such as angioplasty and bypass surgery), according to a study in the March 16 of JAMA.

According to background information, more than 280,000 Medicare enrollees are admitted to hospitals with AMI annually. "These patients face a high risk of short-term death: 18 percent die within 30 days of admission," the authors write. "Much of the effort to reduce this high mortality rate has focused on invasive diagnostic and therapeutic interventions." The authors continue, "Noninvasive, inexpensive, medical management, including aspirin, angiotensin-converting enzyme inhibitors [ACE inhibitors], and beta-blockers [medications used to treat high blood pressure], as well as thrombolysis [therapy to reduce blood clots], reduces mortality (death) following AMI."

Therese A. Stukel, Ph.D., from Dartmouth Medical School, Hanover, N.H., and colleagues analyzed data from 158,831 elderly Medicare patients hospitalized with a first episode of confirmed AMI in 1994 – 1995, followed up for 7 years. The researchers examined the intensity of invasive management (measured as whether the patients received a cardiac catheterization within 30 days), and medical management (measured by prescription of beta-blockers to appropriate patients at discharge from hospital).

The researchers found that the patients’ initial AMI severity was similar across all regions. "In all regions, younger and healthier patients were more likely than older high-risk patients to receive intensive treatment and medical therapy," the researchers note. "Regions with more invasive treatment practice styles had more cardiac catheterization laboratory capacity; patients in these regions were more likely to receive interventional treatment, regardless of age, clinical indication, or risk profile. The absolute unadjusted difference in 7-year survival between regions providing the highest rates of both invasive and medical management strategies and those providing the lowest rates of both was 6.2 percent."

"Our study confirmed that clinicians were more likely to provide invasive treatments to lower-risk than higher-risk patients in this population, despite evidence demonstrating that these treatments are associated with greater absolute improvements in older, higher-risk patients," the authors write. "Second, a more intensive medical management style was associated with improved survival regardless of the level of invasive management in the region; however, in regions with high medical management intensity, there appeared to be little or no marginal improvement associated with additional invasive treatment."

In conclusion the authors write: "Debate continues regarding the value of routine use of high technology treatment for cardiac patients. While AMI survival has improved compared with 30 years ago, invasive treatment and medical management are not optimal as practiced in the United States. ... We recommend first, that a comprehensive, systems-minded approach to delivering evidence-based medical management to AMI patients be a national priority."
(JAMA. 2005;293:1329-1337. Available post-embargo at jama.com)

Editor's Note: Please see the JAMA study for funding information.

COMMENTARY: REGIONALIZATION OF CARE FOR ACUTE CORONARY SYNDROMES

In an accompanying commentary, Saif S. Rathore, M.P.H., from Yale University School of Medicine, New Haven, Conn., and colleagues write, "there is a growing movement advocating the treatment of patients with acute coronary syndromes (ACS) at regional centers with dedicated facilities. Proponents contend that regionalized ACS care will save lives by improving access to new technologies, specialist physicians, and higher-quality care not available at other centers. ... In this article, we present concerns about the rationale for regionalized ACS care and outline some potential unintended consequences."

"As the article by Stukel and colleagues in this issue of JAMA suggests, treating ACS patients with high-quality medical care, which can be accomplished by all hospitals without additional facilities, may reduce the need for interventional procedures. Also, focusing on the adoption of newer therapies ignores the fact that many inexpensive, readily available, established therapies remain underused in ACS patients."

"No study to date has provided convincing evidence that triaging patients to higher-volume hospitals will actually reduce mortality. Hospital size, technology, and specialization do not guarantee high-quality ACS care, just as the absence of these attributes does not preclude high-quality ACS care."

"... the current data are insufficient to endorse a policy requiring such a fundamental change. Clear, compelling evidence of the benefits of ACS regionalization within the United States and a better understanding of its potential consequences are needed before implementing a national policy of regionalized ACS care."
(JAMA. 2005;293:1383-1387. Available post-embargo at jama.com)

Editor's Note: Mr. Rathore is supported by a National Institutes of Health/National Institute of General Medical Sciences Medical Scientist Training grant. Co-author Dr. Volpp is supported by a VA HSR & D Research Career Development Award and a Doris Duke Charitable Foundational Clinical Scientist Development Award.

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 p.m. CT, TUESDAY, March 15, 2005
Media Advisory: To contact Eva Lonn, M.D., call Veronica McGuire at 905-525-9140, ext. 22169. To contact editorialist B. Greg Brown, M.D., Ph.D., call Pam Sowers at 206/685-4232.

STUDY INDICATES THAT VITAMIN E DOES NOT PREVENT CANCER OR MAJOR CARDIOVASCULAR EVENTS, BUT MAY INCREASE RISK FOR HEART FAILURE

CHICAGO—Patients who took vitamin E supplements for about 7 years did not have their risk of cancer or cardiovascular events significantly reduced, and in fact some had an increased risk of heart failure, according to a study in the March 16 issue of JAMA.

Experimental and epidemiological data have suggested that vitamin E supplementation may prevent cancer and cardiovascular events, according to background information in the article. Clinical trials have generally failed to confirm benefits, possibly due to their relatively short duration.

Eva Lonn, M.D., of the Population Health Research Institute and McMaster University, Hamilton Health Sciences Corporation, Hamilton, Ontario, Canada, and colleagues conducted a study to evaluate whether long-term supplementation with vitamin E decreases the risk of cancer, cancer death, and major cardiovascular events. The randomized, double-blind, placebo-controlled trial (Heart Outcomes Prevention Evaluation [HOPE]) was initially conducted between December 21, 1993, and April 15, 1999, and included patients at least 55 years old with vascular disease or diabetes mellitus. This trial was extended (HOPE-The Ongoing Outcomes [HOPE-TOO]) to between April 16, 1999, and May 26, 2003.

Of the initial 267 HOPE centers that had enrolled 9,541 patients, 174 centers participated in the HOPE-TOO trial. Of 7,030 patients enrolled at these centers, 916 were deceased at the beginning of the extension, 1,382 refused participation, 3,994 continued to take the study intervention, and 738 agreed to follow-up. Median duration of follow-up was 7.0 years. Patients received a daily dose of natural source vitamin E (400 IU) or matching placebo.

The researchers found: "In the HOPE and HOPE-TOO trials, the daily administration of 400 IU of natural source vitamin E for a median of 7.0 years had no clear impact on fatal and nonfatal cancers, major cardiovascular events, or deaths. We observed an increase in the risk of heart failure, which is of concern. Although this adverse effect of vitamin E was unexpected and cannot be confirmed at this time by other trials, our data are internally consistent. Therefore, a meta-analysis of heart failure events including all completed large vitamin E trials is strongly recommended."

"In conjunction with its lack of efficacy, the potential for harm suggested by our findings strongly supports the view that vitamin E supplements should not be used in patients with vascular disease or diabetes mellitus," the authors write. "Our study also has wider implications. There is a tendency to accept 'natural products' (e.g., vitamins) as being safe, even if they have not been proven to be effective. However, our findings emphasize the need to thoroughly evaluate all vitamins, other natural products, and complementary medicines in appropriately designed trials before they are widely used for presumed health benefits."
(JAMA. 2005;293:1338-1347. Available post-embargo at jama.com)

Editor's Note: For funding/support and financial disclosure information, please see the JAMA article.

EDITORIAL: IS THERE ANY HOPE FOR VITAMIN E?

In an accompanying editorial, B. Greg Brown, M.D., Ph.D., of the University of Washington School of Medicine, and John Crowley, Ph.D., of the University of Washington School of Public Health and Community Medicine, Seattle, discuss the findings of the HOPE-TOO trial.

"Why is this report important? First, by extending HOPE and adding to the growing list of neutral prospective vitamin E trials, this report effectively closes the door on the prospect of a major protective effect of long-term exposure to this supplement, taken in moderately high dosage, against complications of atherosclerosis and overall cancer incidence. Second, in doing so, HOPE-TOO reemphasizes the importance of controlled clinical trials for testing important hypotheses deriving from basic biological findings or from epidemiological observations. The latter can mislead; well-designed clinical trials rarely do."

"The hopes for vitamin E alone or in combination with vitamin C and beta carotene have been diminished by a compelling body of clinical trial evidence, and by certain adverse effects with plausible biological explanation. These hopes are now confined to modest expectations for specific disorders and there are concerns about adverse effects. While there is solid evidence linking oxidative processes to human disease (as well as to normal biological function), the details of these processes and of proposed therapeutic or preventive interventions appear to need considerable rethinking," they conclude.
(JAMA. 2005;293:1387-1390. Available post-embargo at jama.com)

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 p.m. CT, TUESDAY, March 15, 2005
Media Advisory: To contact Daniela Fialová, Pharm.D., email: fickova@faf.cuni.cz.

USE OF POTENTIALLY INAPPROPRIATE MEDICATIONS AMONG ELDERLY INDIVIDUALS COMMON IN SOME EUROPEAN COUNTRIES

CHICAGO—There are substantial differences between European countries in the potentially inappropriate use of medications among elderly home care patients, according to a study in the March 16 issue of JAMA.

Use of potentially inappropriate medications in elderly patients is a major health care concern, according to background information in the article. It is likely to increase the risk of adverse drug events, which are estimated to be the fifth most common cause of death among hospitalized patients and which account for a large number of hospital admissions and a substantial increase in health care costs.

In the United States and Canada, epidemiological studies have documented widespread use of potentially inappropriate medications among nursing home residents (up to 40 percent) and community-dwelling elderly persons (14 percent-37 percent). In contrast, in Europe little information has been available about potentially inappropriate medication use and is based on small studies with uncertain generalizability.

Daniela Fialová, Pharm.D., of Charles University, Prague, Czech Republic, and colleagues conducted a study to determine from a large sample of European home care elderly patients the prevalence of potentially inappropriate medication use. The study included 2,707 elderly patients receiving home care (average age, 82.2 years) in metropolitan areas of the Czech Republic, Denmark, Finland, Iceland, Italy, the Netherlands, Norway, and the United Kingdom. Patients were assessed between September 2001 and January 2002.

Combining 3 sets of expert panels criteria, the researchers found that 19.8 percent of patients in the total sample used at least 1 inappropriate medication; using older 1997 criteria it was 9.8 percent to 10.9 percent. Substantial differences were documented between Eastern Europe (41.1 percent in the Czech Republic) and Western Europe (average 15.8 percent, ranging from 5.8 percent in Denmark to 26.5 percent in Italy). Potentially inappropriate medication use was associated with patient's poor economic situation (nearly two times increased risk), polypharmacy (the administration of many drugs at the same time, nearly twice the risk), anxiolytic (medication used to reduce anxiety or agitation) drug use (1.8 times increased risk), and depression (1.3 times increased risk). The odds of potentially inappropriate medication use significantly increased with the number of associated factors.

Individuals aged 85 years or older and those living alone were less likely to receive inappropriate medications.

"In Europe, use of potentially inappropriate medications among frail community-dwelling elderly persons appears to be common, with substantial regional variations. The differences likely reflect country-specific drug policies, care provision differences, inequalities in socioeconomic background, differences in overall health conditions, and specific regulatory measures. While regional preferences for some inappropriate medications need a more in-depth evaluation, these variations indicate amenability to intervention, particularly in Eastern Europe. Future efforts should be targeted to modifiable correlates of inappropriate medication use and research should focus on outcomes and intervention strategies," the authors write.

"Despite previous criticism of the expert panels' criteria for their simplicity, these tools increase clinicians' awareness about potentially inappropriate medications for older patients. Thoughtful adoption of these criteria by regulatory institutions, national guidelines, and computerized alert systems might improve prescribing. Because one of the current principal aims of the European Union is to improve practice, rules, and regulations throughout Europe, harmonizing drug policy and regulatory measures with respect to potentially inappropriate medication use should be a major focus (e.g., withdraw ineffective and/or harmful medications, establish prescribing limits for the elderly, approve safer alternatives, harmonize prescribing guidelines). These strategies could help ensure that prescribing for older patients in Europe is improved and consistent across countries," the researchers conclude.
(JAMA. 2005;293:1348-1358. Available post-embargo at jama.com)

Editor's Note: This study is an ancillary study of the European AdHOC (Aged in Home Care) project, supported by the EU Commission under the Vth Framework Programme.

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 p.m. CT, TUESDAY, March 15, 2005
Media Advisory: To contact Joel S. Weissman, Ph.D., call Emily Parker at 617-724-6425.

MOST HOSPITAL EXECUTIVES HAVE SUBSTANTIAL CONCERNS ABOUT MANDATORY ERROR REPORTING SYSTEMS

CHICAGO—A survey of hospital leaders indicates that many have serious reservations about a mandatory error reporting system, including that it would discourage event reporting and increase the risk of lawsuits, according to a study in the March 16 issue of JAMA.

Since the early 1990s, much has been learned about medical errors in health care settings, and about their impact on illness, death, and costs, according to background information in the article. Although a number of approaches to reduce errors were proposed, a key strategy involved the use of reporting systems to identify and learn from errors. The Institute of Medicine has recommended establishing both mandatory and voluntary reporting systems for health care institutions such as hospitals and nursing homes. The purpose of reporting is to collect data on a broad range of events to detect systemic problems that can be altered to reduce the risk of patient harm. As of October 2003, 21 states had mandatory event reporting systems for hospitals, although policies varied.

Joel S. Weissman, Ph.D., of the Institute for Health Policy, Massachusetts General Hospital, Boston, and colleagues conducted a study to elicit the views of hospital executives with regard to mandatory state reporting systems and closely related issues of patient safety. The researchers surveyed chief executive and chief operating officers (CEOs/COOs) from randomly selected hospitals in 2 states with mandatory reporting and public disclosure, 2 states with mandatory reporting without public disclosure, and 2 states without mandatory systems in 2002-2003.

Responses were received from 203 of 320 hospitals (response rate=63 percent). The researchers found that most CEOs/COOs thought that a mandatory, nonconfidential system would discourage reporting of patient safety incidents to their hospital's own internal reporting system (69 percent) and encourage lawsuits (79 percent) while having no effect or a negative effect on patient safety (73 percent). More than 80 percent felt that the names of both the hospital and the involved professionals should be kept confidential, although respondents from states with mandatory public disclosure systems were more willing than respondents from the other states to release the hospital name (22 percent vs. 4 to 6 percent).

When presented with hypothetical clinical vignettes, more than 90 percent of hospital leaders said their hospital would report incidents involving serious injury to the state, but far fewer would report moderate or minor injuries, even when the incident was of sufficient consequence that they would tell the affected patient or family.

"In the hospital setting, executive leaders influence institutional policy and foster norms for their employees. These individuals believe that existing state reporting standards fail in some cases to provide clear guidance on what should be reported and that mandatory reporting systems with public disclosure may actually discourage internal reporting, lead to lawsuits, and impart little benefit to patient safety. Hospital leaders, of course, have their own institutional biases, and there is some evidence that hospitals that become accustomed to transparency may eventually grow to be more accepting of it. However, if hospital leaders continue to harbor negative views of reporting, it is unlikely that state mandatory reporting systems will be highly successful in the long run," the authors write.
(JAMA. 2005;293:1359-1366. Available post-embargo at jama.com)

Editor's Note: This work was supported by a cooperative agreement from the Agency for Healthcare Research and Quality.

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.

JAMA REPORTS

DAILY VITAMIN E LINKED TO INCREASED RISK OF HEART FAILURE

VIDEO:
B-ROLL
Jim talking with doctor in exam room
Vitamin E tablets

AUDIO:
AFTER JIM HILL HAD A QUADRUPLE BYPASS, HE WAS LOOKING FOR WAYS TO REDUCE HIS RISK OF MORE HEART PROBLEMS. HE HEARD THAT VITAMIN E COULD HELP, AND COULD ALSO REDUCE HIS RISK OF CANCER.

AUDIO:
"I was talking to the cardiologist and uh, I was curious about vitamin E, and there was no studies on it but he said it wouldn’t hurt for me to take it."

VIDEO:
B-ROLL
GFX/JAMA COVER
Jim talking with Dr. Lonn in exam room

AUDIO:
BUT A NEW STUDY IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, SHOWS THAT VITAMIN E MAY INDEED HURT PEOPLE LIKE JIM-- WHO ARE OVER AGE 55 WITH A HISTORY OF HEART PROBLEMS, DIABETES, OR OTHER RISK FACTORS FOR CARDIOVASCULAR DISEASE.

VIDEO:
SOT/FULL
@ :35
Super: Eva Lonn, M.D.
McMaster University
Runs :17

AUDIO:
"In high-risk people, vitamin E does not prevent cardiovascular disease, namely heart attack and stroke, and it does not prevent cancer. Furthermore, we noticed an increased risk of heart failure, so there is a potential for harm in people receiving vitamin E."

VIDEO:
B-ROLL
Dr. Lonn with colleagues at conference table
Dr. Lonn at computer with different colleague
Different man taking Vitamin E at kitchen sink
Cutaways of man pouring pill into hand, pill in man’s hand

AUDIO:
DR. EVA LONN, OF McMASTER UNIVERSITY IN ONTARIO, CANADA, ALONG WITH RESEARCHERS FROM THE U.S. AND THIRTEEN OTHER COUNTRIES, CONDUCTED THE VITAMIN E STUDY. THEY TRACKED THE HEALTH OF MORE THAN NINE-THOUSAND HIGH-RISK PATIENTS, SOME FOR AS LONG AS ALMOST TEN YEARS. THEY COMPARED THOSE TAKING 400 INTERNATIONAL UNITS OF VITAMIN E A DAY, TO THOSE TAKING A PLACEBO, OR SUGAR PILL. THE RESULTS FOR THOSE WHO TOOK VITAMIN E THE LONGEST WERE DRAMATIC.

VIDEO:
SOT/FULL
Eva Lonn, M.D.
McMaster University
Runs :06

AUDIO:
"We noticed actually a 40 percent increase in risk of hospital admission for heart failure."

VIDEO:
B-ROLL
Vitamin E on store shelves

AUDIO:
SO, DR. LONN SAYS DOCTORS AND PATIENTS NEED TO RE-THINK VITAMIN E.

VIDEO:
SOT/FULL
Eva Lonn, M.D.
McMaster University
Runs :09

AUDIO:
"There is often the belief, well even if it doesn’t benefit you, it causes no harm. Now, our study suggests that this assumption is not always correct."

VIDEO:
B-ROLL
Jim lying on exam table, having blood pressure taken by Dr. Lonn

AUDIO:
JIM WAS PART OF THAT STUDY, AND FELT RELIEVED WHEN HE LATER LEARNED THAT HE WAS TAKING PLACEBO, NOT VITAMIN E. NOW HE TAKES PRESCRIPTION MEDICATIONS FOR HIS HEART HEALTH.

VIDEO:
NAT SOT UP FULL FOR :06
Dr. Lonn talking with Jim

AUDIO:
"All in all, things look pretty good, so carry on with the same medications."

VIDEO:
B-ROLL
Jim talking with Dr. Lonn
Vitamin E pills

AUDIO:
HE SAYS HE’LL FOLLOW DOCTORS’ ORDERS, WHICH DON’T INCLUDE TAKING VITAMIN E. THIS IS MAVIS PRALL REPORTING.