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 4, 2006)
JAMA NEWS RELEASES
STUDIES INDICATE MEDICATION CAN BE AN EFFECTIVE THERAPY FOR SMOKING CESSATION
HIGHER LEVELS OF OBESITY ASSOCIATED WITH GREATER HEALTH RISKS
RESULTS OF HOSPITAL PERFORMANCE MEASURES DO NOT ALWAYS REFLECT PATIENT OUTCOMES
JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)
VIDEO: Windows Media | Quicktime
EXTREME OBESITY IN WOMEN INCREASING, LINKED TO GREATER RISK OF DEATH
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Embargoed for Release: 3:00 p.m. CT, Tuesday, July 4, 2006
Media Advisory: To contact David Gonzales, Ph.D., call Tamara Hargens at 503-494-8231. To contact Douglas E. Jorenby, Ph.D., call Gloria Meyer at 608-265-4447. To contact Serena Tonstad, M.D., Ph.D., email: serena.tonstad{at}uus.no. To contact editorial co-author Robert C. Klesges, Ph.D., call Sheila Champlin at 901-448-4957.
STUDIES INDICATE MEDICATION CAN BE AN EFFECTIVE THERAPY FOR SMOKING CESSATION
CHICAGO—The drug varenicline shows effectiveness in helping smokers quit and abstain from smoking when compared to placebo and the smoking cessation medication bupropion, according to three studies in the July 5 issue of JAMA.
Although nearly 41 percent of smokers try to quit smoking each year, relapse is common, and only about 10 percent achieve and maintain abstinence. The negative effects of nicotine withdrawal account, in part, for low success rates, according to background information in the article. Approved pharmacotherapies to treat nicotine dependence (e.g., nicotine replacement therapy and bupropion) have had important, but moderate efficacy, with reported rates of quitting generally twice those of placebo. Additional and more effective therapies are needed.
David Gonzales, Ph.D., of Oregon Health & Science University, Portland, and colleagues with the Varenicline Phase 3 Study Group evaluated the efficacy of varenicline compared with placebo and sustained-release (SR) bupropion in generally healthy adult smokers. Varenicline is a non-nicotine drug that is thought to be beneficial for smoking cessation by stimulating the release of the chemical dopamine in the brain to reduce craving and withdrawal while simultaneously blocking the reinforcing effects of smoked nicotine. Most other smoking cessation pharmacotherapies are nicotine replacement products.
Participants in the study were 1,025 smokers (10 cigarettes or more per day) with fewer than 3 months of smoking abstinence in the past year. The randomized, double-blind, phase 3 clinical trial was conducted at 19 U.S. centers from June 2003 to April 2005. Participants were randomly assigned to receive brief counseling plus either varenicline twice per day (n = 352), bupropion SR twice per day (n = 329), or placebo (n = 344) orally for 12 weeks, with 40 weeks of nondrug follow-up.
The carbon monoxide–confirmed 4-week continuous abstinence rate for weeks 9 through 12 was superior for varenicline (44.0 percent) vs. placebo (17.7 percent) and vs. bupropion SR (29.5 percent). Bupropion SR was also superior to placebo. The continuous abstinence rate for weeks 9 to 24 was superior for varenicline (29.5 percent) vs. placebo (10.5 percent) and vs. bupropion SR (20.7 percent). The continuous abstinence rate for weeks 9 through 52 was significantly greater for varenicline (21.9 percent) than for placebo (8.4 percent) but no longer significant compared with bupropion SR (16.1 percent).
Varenicline reduced craving and withdrawal and, for those who smoked while receiving study drug, also reduced smoking satisfaction. No sex differences in efficacy for varenicline were observed. Varenicline was safe and generally well tolerated, with study drug discontinuation rates similar to those for placebo. The most common adverse events for participants receiving active-drug treatment were nausea for varenicline and insomnia for bupropion SR.
“Varenicline is an efficacious therapy for smoking cessation. In this trial, varenicline was more efficacious than placebo at all time points and more efficacious than bupropion SR at the end of 12 weeks of treatment and at 24 weeks,” the authors write.
(JAMA. 2006;296:47-55. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was supported by Pfizer Inc., which provided funding, study drug and placebo, and monitoring. For the financial disclosures of the authors, please see the JAMA article.
VARENICLINE SHOWS LONG-TERM EFFECTIVENESS
In another study, Douglas E. Jorenby, Ph.D., of the University of Wisconsin School of Medicine and Public Health, Madison, Wis., and colleagues with the Varenicline Phase 3 Study Group conducted a study designed identical to that of Gonzales et al to assess the efficacy and safety of varenicline for smoking cessation compared with placebo and bupropion SR during initial treatment and long-term follow-up.
This randomized, double-blind, placebo-controlled trial was conducted at 14 research centers between June 2003 and March 2005 and consisted of a 12-week treatment period with follow-up of smoking status to week 52. The study included 1,027 adult smokers, 65 percent of whom completed the study. The participants were randomized to varenicline twice daily (n = 344), bupropion SR twice daily (n = 342) or placebo (n = 341) for 12 weeks, plus weekly brief smoking cessation counseling.
The researchers found that varenicline produced higher continuous abstinence rates than placebo at all time points. During the last 4 weeks of treatment (weeks 9-12), 43.9 percent of participants in the varenicline group were continuously abstinent from smoking compared with 17.6 percent in the placebo group and 29.8 percent in the bupropion SR group. For weeks 9 through 24, 29.7 percent of participants in the varenicline group were continuously abstinent compared with 13.2 percent in the placebo group and 20.2 percent in the bupropion group. For weeks 9 through 52, 23 percent of participants in the varenicline group were continuously abstinent compared with 10.3 percent in the placebo group and 14.6 percent in the bupropion SR group.
“At the end of the treatment period, the odds of quitting smoking with varenicline were significantly greater than the odds of quitting with either placebo or bupropion SR,” the authors write.
Treatment was discontinued due to adverse events by 10.5 percent of participants in the varenicline group, 12.6 percent in the bupropion SR group, and 7.3 percent in the placebo group. The most common adverse event with varenicline was nausea, which occurred in 101 participants (29.4 percent).
“Reducing smoking rates in the U.S. population will require a combination of efforts from individuals, health care systems, insurers, and policy makers as part of a comprehensive tobacco-control strategy. Advances can be made by improving the use of existing smoking cessation treatments and by developing better treatments. Varenicline ...has demonstrated a robust ability to increase cessation rates (short-term and long-term) compared with both placebo and a first-line smoking cessation medication (bupropion SR), and may represent an advance in the treatment of tobacco dependence,” the authors conclude.
(JAMA. 2006;296:56-63. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: The data reported in this article were derived from a clinical trial sponsored by Pfizer Inc., which provided funding, study drug and placebo, and monitoring. For the financial disclosures of the authors, please see the JAMA article.
VARENICLINE HELPS TO PREVENT RELAPSE FOR SMOKERS WHO HAVE ACHIEVED ABSTINENCE
In another study, Serena Tonstad, M.D., Ph.D., of Ulleval University Hospital, Oslo, Norway and colleagues with the Varenicline Phase 3 Study Group conducted a randomized, double-blind, placebo-controlled trial evaluating the efficacy of an additional 12 weeks of varenicline used for relapse prevention in smokers who successfully achieved abstinence following an initial 12-week varenicline treatment.
According to background information in the article, 50 percent to 60 percent of people who are initially successful at quitting smoking go on to relapse within a year. A recent comprehensive review of existing studies concluded that currently there is no evidence-based relapse prevention intervention available.
The study was conducted at multiple medical clinics in 7 countries with follow-up to 52 weeks after study baseline. Of 1,927 cigarette smokers recruited between April 2003 and February 2004 and treated for 12 weeks with open-label varenicline twice per day, 1,236 (64.1 percent) did not smoke, use tobacco, or use nicotine replacement therapy during the last week of treatment and 62.8 percent (n = 1,210) were randomized to additional treatment or placebo. Participants were assigned to receive either varenicline, 1.0 mg twice per day (n = 603), or placebo (n = 607) for an additional 12 weeks.
The continuous abstinence rate for weeks 13 to 24 was higher for participants randomized to varenicline than for participants randomized to placebo (70.5 percent vs. 49.6 percent). The continuous abstinence rate for weeks 13 to 52 was also higher for the varenicline group than for the placebo group (43.6 percent vs. 36.9 percent). Adverse events reported in the open-label period were mostly mild; no difference in adverse events between varenicline and placebo was observed during the double-blind period.
“In the field of relapse prevention—in which there is a notable lack of positive findings—these results represent an important new development,” the authors write.
The researchers add that at the end of this trial, as in all existing literature on smoking cessation with 1 year of follow-up, more than 50 percent of participants in each group returned to smoking. “Thus, an examination of longer medication periods is warranted.”
“In conclusion, extended use of varenicline helps recent ex-smokers to maintain their abstinence and prevent relapse. Varenicline is the first smoking cessation treatment to demonstrate a significant long-term relapse prevention effect,” the authors write.
(JAMA. 2006;296:64-71. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This study was sponsored by Pfizer Inc., which provided funding, study drug and placebo, and monitoring. For the financial disclosures of the authors, please see the JAMA article.
EDITORIAL: VARENICLINE FOR SMOKING CESSATION — DEFINITE PROMISE, BUT NO PANACEA
In an accompanying editorial, Robert C. Klesges, Ph.D., Karen C. Johnson, M.D., M.P.H., and Grant Somes, Ph.D., of the University of Tennessee Health Science Center, Memphis, Tenn., comment on the studies on varenicline and smoking cessation.
“It is important for clinicians to moderate some of the potential enthusiasm that is likely to occur as the result of the publication of these trials, FDA approval of the drug, and promotion by this manufacturer. On the one hand, these studies demonstrate that varenicline is associated with higher smoking cessation rates than placebo and may produce better cessation rates than bupropion, a first-line–approved smoking cessation drug. Importantly, varenicline represents a third class of drug with probably a different mechanism of action than either nicotine replacement therapy or bupropion. On the other hand, varenicline definitely is not a panacea for smoking cessation. Many participants in these trials experienced adverse events, stopped taking their study medication before they should have, and discontinued participation in the studies. Importantly, the majority of participants in these 3 studies did not quit smoking even with varenicline.”
“Clearly, quitting smoking, even with pharmacological and behavioral assistance, is extremely difficult. Patients currently cannot and probably never will simply be able to ‘take a pill’ that will make them stop smoking. Smokers must want to stop smoking and must be willing to work hard to achieve the goal of smoking abstinence,” the authors write. “Although much research needs to be conducted to establish the effectiveness of varenicline, stop smoking researchers and clinicians, as well as smokers wanting to quit smoking, now have another product available that appears to help increase the probability of smoking cessation.”
(JAMA. 2006;296:94-95. Available pre-embargo to the media at www.jamamedia.org)
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 4, 2006
Media Advisory: To contact Kathleen McTigue, M.D., M.S., M.P.H., call Gloria Kreps at 412-647-3555.
HIGHER LEVELS OF OBESITY ASSOCIATED WITH GREATER HEALTH RISKS
CHICAGO—The health risks for women who are extremely obese may be underestimated as a new study indicates they have a higher prevalence of hypertension, diabetes, and high cholesterol than women at lower levels of obesity, according to a study in the July 5 issue of JAMA.
Obesity diagnosis and treatment are typically based on body mass index (BMI) of at least 30. BMI is calculated as weight in kilograms divided by height in meters squared. However, three categories of obesity are defined: obesity 1 (30-34.9); obesity 2 (35-39.9); and extreme obesity (40 and greater). (A 5’4” person would have a BMI of 40 if they weighed 233 lbs). The latter 2 categories, sometimes termed severe obesity, are reported to be increasing especially rapidly in the United States, according to background information in the article. From 1986 to 2000, prevalence of BMI of 30 or higher approximately doubled, while that of BMI of 40 or higher quadrupled and that of BMI of 50 or higher increased 5-fold. In 2000, 2.8 percent of all U.S. women, and 6 percent of black women reported measurements consistent with extreme obesity. Estimates of obesity-related risks in women have generally been based on weight data that preceded the increase in extreme obesity. It has been unclear whether health risk increases or plateaus as body weight increases throughout the obese range.
Kathleen McTigue, M.D., M.S., M.P.H., of the University of Pittsburgh, and colleagues conducted a study to examine the relationship between weight category and risk of death and coronary heart disease (CHD) in a large population-based sample of U.S. women, focusing on risk across degree of obesity. The researchers analyzed data on incident death and cardiovascular outcomes by weight status in 90,185 women recruited from 40 U.S. centers for the Women’s Health Initiative-Observational Study who were followed-up for an average of 7.0 years (Oct. 1993 to Aug. 2004).
The researchers found that extreme obesity prevalence differed with race/ethnicity, from 1 percent among Asian and Pacific Islanders to 10 percent among black women. “In this diverse population-based sample of older women, we found that obesity was linked with considerable health risk and that accounting for degree of excess weight is important in understanding weight-related health risk. Overall, extremely obese women were more likely to die over the average 7.0 years of follow-up than were women in other examined weight categories. Modeling analyses adjusted for age, smoking status, educational achievement, U.S. region, and physical activity level showed that weight-related risk for all-cause mortality, CHD mortality, and CHD incidence did not differ by race/ethnicity.”
“There was a positive trend in all-cause mortality risk and CHD incidence with increasing weight category. This trend had borderline significance for CHD mortality among black women, likely reflecting sample size limitations. Much of the obesity-related mortality and CHD risk was mediated by diabetes, hypertension, and hyperlipidemia [high cholesterol levels]. In white women, as other studies have found, weight-related all-cause mortality risk was modified by age, with obesity conferring less risk among older women. Smoking may modify weight-related risk in black women, but further study is needed to understand the nature of this relationship,” the authors write.
“Our findings have important clinical and policy implications. The escalating prevalence of extreme obesity may exacerbate the health effects and health-related expenditures resulting from the U.S. obesity epidemic. Calculating the weight-related risks of morbidity and mortality based on findings in earlier population samples, which tended to reflect lower degrees of obesity, may underestimate the risks for extremely obese individuals and overestimate the risks for mildly obese individuals in diverse groups,” the researchers write. “More accurately assessing weight-related health risk may both improve policy decisions about obesity and assist women in making informed decisions about their health.”
(JAMA. 2006;296:79-86. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: The Women’s Health Initiative program is funded by the National Heart, Lung, and Blood Institute, U.S. Department of Health and Human Services. Dr. McTigue was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.
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 4, 2006
Media Advisory: To contact corresponding author Harlan M. Krumholz, M.D., S.M., call Jacqueline Weaver at 203-432-8555. To contact editorialist Ashish K. Jha, M.D., M.P.H., call Robin Herman at 617- 432-4752.
RESULTS OF HOSPITAL PERFORMANCE MEASURES DO NOT ALWAYS REFLECT PATIENT OUTCOMES
CHICAGO—Hospital quality measures do not fully account for the variation in hospital death rates for heart attack patients, according to a study in the July 5 issue of JAMA.
As part of the national effort to improve hospital quality, the Centers for Medicare & Medicaid Services (CMS) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) monitor and publicly report hospital performance on acute myocardial infarction (AMI – heart attack) “core” process measures approved by the Hospital Quality Alliance, according to background information in the article. Although the CMS/JCAHO process measures are considered indicators of quality of AMI care, little is known about how these measures track with each other. And the degree to which process measure performance conveys meaningful information about short-term death rates remains unclear.
Elizabeth H. Bradley, Ph.D., of the Yale University School of Medicine, New Haven, Conn., and colleagues used data from the National Registry of Myocardial Infarction (NRMI) and CMS to determine the correlations among AMI process measures and the association between hospital performance on process measures and hospital-specific, risk-standardized, 30-day death rates, derived from Medicare claims data. The researchers used 2002-2003 data from 962 hospitals participating in the NRMI and used information on AMI patients aged 66 years or older.
The researchers found moderately strong correlations between beta-blocker use at admission and discharge, aspirin use at admission and discharge, and angiotensin-converting enzyme (ACE) inhibitor use, and weaker, but statistically significant, correlations between these medication measures and smoking cessation counseling and time to reperfusion therapy measures. Some process measures were significantly correlated with risk-standardized, 30-day death rates but together explained only 6.0 percent of hospital-level variation in risk-standardized, 30-day death rates for patients with AMI.
“This finding suggests that a hospital’s short-term mortality rates after AMI cannot be reliably inferred from performance on the publicly reported process measures. Our results highlight that the current process measures provide information that is complementary to, but not redundant with, a measure of 30-day mortality,” the authors write.
“In conclusion, although the core measures are important in pursuing improved AMI outcomes, they capture in aggregate only a small proportion of the hospital-level variation in short-term 30-day mortality rates. Until additional process measures are developed that explain more of the variation, reporting not only the current core measures but also short-term risk-standardized mortality rates is a reasonable approach to characterize hospitals’ overall quality of care,” the researchers write.
(JAMA. 2006;296:72-78. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: For funding/support information, please see the JAMA article.
EDITORIAL: MEASURING HOSPITAL QUALITY — WHAT PHYSICIANS DO? HOW PATIENTS FARE? OR BOTH?
In an accompanying editorial, Ashish K. Jha, M.D., M.P.H., of the Harvard School of Public Health and Brigham and Women’s Hospital, Boston, comments on the findings by Bradley et al.
“Although the U.S. health care system is now committed to quality measurement and the public reporting of such data, debates will continue about what to measure, who collects the data, and what to report publicly. More information is needed on processes and outcomes across a large number of conditions for hospitals, physician practices, and other health care settings and practitioners. Much of these data are on their way, led by major payers such as Medicare and coalitions of employers who want greater accountability for the care they purchase and to stimulate improvements in quality of care. In the most expensive health care system in the world, patients and physicians should expect nothing less.”
(JAMA. 2006;296:95-97. Available pre-embargo to the media at www.jamamedia.org)
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
EXTREME OBESITY IN WOMEN INCREASING, LINKED TO GREATER RISK OF DEATH
VIDEO:
NAT SOT UP FULL FOR :03
Dr. Fernstrom holding different measuring cups
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“You say a half a cup of vegetables, you have to find the one.”
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Dr. Fernstrom with patient in consultation room, plastic food portions on table
Two obese white women together
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DR. MADELYN FERNSTROM SPECIALIZES IN TEACHING PEOPLE WITH WEIGHT PROBLEMS TO EAT WELL. SHE’S SEEING A DISTURBING TREND AMONG HER HUNDREDS OF FEMALE OBESE PATIENTS.
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Super: Madelyn Fernstrom, Ph.D., CNS
Univ. of Pittsburgh Medical Center
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“In the last several years I’ve seen a big increase in not just the number of women seeking help but they’re larger and larger and getting medically sicker.”
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Obese black woman
Obese white woman
GFX/JAMA COVER
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THAT’S EXACTLY WHAT’S HAPPENING ACROSS THE U.S., ACCORDING TO A NEW STUDY IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
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Super: Kathleen McTigue, M.D., M.S., M.P.H.
University of Pittsburgh
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“Before, we knew that extreme obesity was increasing but we didn’t understand what the health implications were for that. Now we understand that extremely obese women are more likely to die than women with lesser degrees of obesity.”
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Dr. McTigue at wipe board with colleague
Obese white women
Obese black woman
FULL SCREEN GRAPHIC (over image of woman)
Height 5’5”
Weight 190 lbs = 12% higher risk of death
Weight 250 lbs = 86% higher risk of death
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DR. KATHLEEN McTIGUE (long “I”) OF UNIVERSITY OF PITTSBURGH AND HER COLLEAGUES TRACKED THE HEALTH OF MORE THAN NINETY-THOUSAND WOMEN FOR ABOUT SEVEN YEARS. THEY FOUND THAT THE HEAVIER THE WOMAN, THE GREATER THE RISK OF DEATH. FOR INSTANCE, LET’S COMPARE WOMEN WHO ARE ALL FIVE FEET FIVE INCHES TALL. A WOMAN WHO WEIGHS ONE-HUNDRED-NINETY POUNDS HAS A TWELVE PERCENT HIGHER RISK OF DEATH THAN A WOMAN WHO WEIGHS ONE-HUNDRED-THIRTY POUNDS. BUT A WOMAN WHO WEIGHS TWO-HUNDRED-FIFTY POUNDS HAS AN EIGHTY-SIX PERCENT HIGHER RISK OF DEATH THAN A WOMAN OF HEALTHY WEIGHT.
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Kathleen McTigue, M.D., M.S., M.P.H.
University of Pittsburgh
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“We found that diabetes, high blood pressure and high cholesterol accounted for much of the obesity-related death risk.”
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Obese white woman
Obese African American woman
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AND THOSE RISKS WERE ESSENTIALLY THE SAME ACROSS ETHNIC GROUPS, THOUGH AFRICAN AMERICAN WOMEN HAD THE HIGHEST PERCENTAGE OF EXTREME OBESITY, AT ABOUT TEN PERCENT.
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Kathleen McTigue, M.D., M.S., M.P.H.
University of Pittsburgh
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“It’s important to understand how risk varies with increasing degree of weight because in the past the risks associated with extreme obesity have been poorly known, because the condition was so rare.”
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Obese white woman
Dr. Fernstrom with patient in consultation room
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BUT IT’S NOT AS RARE NOW, AND DR. FERNSTROM SAYS SHE’D LIKE TO SEE PEOPLE SEEK HELP FOR THEIR WEIGHT PROBLEMS SOONER.
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Madelyn Fernstrom, Ph.D., CNS
Univ. of Pittsburgh Medical Center
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“I would like to see an early point of change where people come for help a little earlier because it’s much easier to lose 20 pounds or 30 pounds than a hundred pounds.”
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Obese white woman
Obese black woman
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AND THE DIFFERENCE IN THOSE POUNDS COULD BE THE DIFFERENCE BETWEEN LIFE AND DEATH. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
