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, July 5, 2005)

JAMA NEWS RELEASES

   LARGE-SCALE, DECADE-LONG TRIAL INDICATES NO BENEFIT FROM LOW-DOSE ASPIRIN IN PREVENTING CANCER, OR VITAMIN E IN PREVENTING CARDIOVASCULAR DISEASE OR CANCER, IN HEALTHY WOMEN

   STUDY EXAMINES ACCURACY OF PSA VALUES FOR DETECTING PROSTATE CANCER

   NO LINK FOUND BETWEEN LOW ANDROGEN LEVELS AND LOW SEXUAL FUNCTION IN WOMEN

JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)

   VIDEO: Windows Media | Quicktime

   VITAMIN E SHOWN NOT TO PREVENT HEART DISEASE OR CANCER IN HEALTHY WOMEN – ASPIRIN SHOWN NOT TO PREVENT CANCER IN HEALTHY WOMEN

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 whether there is any benefit from taking aspirin or vitamin E in preventing cancer or cardiovascular disease. The release will be fed Tuesday, July 5, 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, July 5, 2005
Media Advisory: To contact Nancy R. Cook, Sc.D., or I-Min Lee, M.B.B.S., Sc.D., call Melanie Franco at 617-534-1600. To contact editorial author Eric J. Jacobs, Ph.D., call Laura Bellinger at 404-417-5839. To contact editorial author Rita F. Redberg, M.D., M.Sc., call Vanessa DeGier at 415-476-2557.

CHICAGO—A major study that includes nearly 40,000 healthy women found no benefit on preventing cancer from taking low-dose aspirin, or benefit on preventing cancer or cardiovascular disease from taking vitamin E, according to two articles in the July 6 issue of JAMA.

A growing body of literature has supported a protective effect of aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) on the development of cancer, according to background information in the first article. Observational epidemiological investigations suggest a strong inverse association, with risk reductions as high as 20 percent to 50 percent for various cancer sites. In contrast with the observational evidence on cancer incidence, data from randomized trials, which provide more definitive results due to their ability to minimize bias and confounding, have been far more limited. The Physicians' Health Study (PHS) found no effect on colorectal cancer of 325 mg aspirin administered every other day over a 5-year randomized period or in post trial follow-up. In addition, no randomized trial has yet assessed the impact of aspirin on the development of breast cancer.

The Women's Health Study (WHS) was a randomized, double-blind, placebo-controlled trial, conducted between September 1992 and March 2004, evaluating the balance of benefits and risks of 100 mg of aspirin every other day, and 600 IU of vitamin E every other day on the primary prevention of cardiovascular disease and cancer in a cohort of 39,876 healthy female health care professionals over an average duration of 10.1 years.

In the first article, Nancy R. Cook, Sc.D., of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues evaluated the findings for the aspirin component of the WHS with regard to cancer risk. In this part of the study, 19,934 women received a dose of 100 mg of aspirin every other day and 19,942 women received placebo.

The researchers found that aspirin had no observed effect on total cancer, breast cancer, colorectal cancer, or cancer of any other site, with the exception of lung cancer for which there was a trend toward reduction in risk (22 percent reduced risk). There was also no reduction in cancer death either overall or by site, except for lung cancer death (30 percent reduced risk). No evidence of differential effects of aspirin by follow-up time or interaction with vitamin E was found.

"The findings from the WHS suggest that aspirin at a dose of 100 mg every other day is not effective in reducing risk of cancer in healthy women, although a beneficial effect on lung cancer cannot be ruled out. This large study of almost 40,000 women had a duration of 10 years of treatment and follow-up, which was the longest of any trial completed to date, and should be sufficient to detect long-term effects. To determine whether higher doses of aspirin taken daily would be effective in cancer prevention requires direct randomized trial data. Such data would need to be considered in the context of risk of gastrointestinal adverse effects before recommending higher-dose aspirin for cancer chemoprevention among low-risk individuals," the authors conclude.
(JAMA. 2005;294:47-55. Available pre-embargo to the media at www.jamamedia.org)

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

EDITORIAL: LOW-DOSE ASPIRIN AND VITAMIN E - CHALLENGES AND OPPORTUNITIES IN CANCER PREVENTION

In an accompanying editorial, Eric J. Jacobs, Ph.D., and Michael J. Thun, M.D., of the American Cancer Society, Atlanta, comment on the findings by Cook et al.

"Should the null results with respect to cancer from this large, well-conducted, long-term randomized trial, or from other chemoprevention trials, be considered discouraging news for cancer chemoprevention in general? There have been some successes in cancer chemoprevention, such as the use of tamoxifen to prevent breast cancer in high-risk women. However, currently, no agent has been shown to do for cancer what statins do for cardiovascular disease, namely substantially and relatively safely reduce disease occurrence in individuals not at especially high risk."

"Pharmacological primary prevention of diseases as heterogeneous as cancer is inherently difficult. Randomized trials of cancer chemoprevention will undoubtedly produce many null results. Nevertheless, continued systematic research on cancer chemoprevention, including long-term randomized trials of carefully chosen agents, is essential given the large potential benefits. At the same time, it is unrealistic to expect the discovery of an agent that will produce substantial reductions in overall cancer rates in the immediate future," authors write.
(JAMA. 2005;294:105-106. Available pre-embargo to the media at www.jamamedia.org)

LONG-TERM VITAMIN E SUPPLEMENTATION SHOWS NO OVERALL BENEFIT FOR MAJOR CARDIOVASCULAR EVENTS OR CANCER IN WOMEN

In an accompanying article in this week's JAMA, I-Min Lee, M.B.B.S., Sc.D., of Brigham and Women's Hospital and Harvard Medical School, Boston, and colleagues analyzed data from the vitamin E component of the Women's Health Study, which tested whether vitamin E supplementation decreases the risk of cardiovascular disease and cancer among healthy women.

According to background information in the article, previous observational studies have indicated that vitamin E may be beneficial in lowering the risk for some cardiovascular diseases; and high antioxidant intake has been linked to reduced cancer rates. For small to moderate effects, however, the amount of uncontrolled and uncontrollable confounding inherent in observational studies can be as large as the postulated benefit, so randomized clinical trials represent the most reliable study design strategy. Randomized trials do not generally support benefits of vitamin E, but there are few trials of long duration among initially healthy persons. By 1997, despite a lack of randomized trials, 44 percent of U.S. cardiologists reported routine use of antioxidant supplements, primarily vitamin E, compared with 42 percent who routinely used aspirin for the primary prevention of CVD.

In this component of the Women's Health Study, 39,876 apparently healthy U.S. women aged at least 45 years were randomly assigned to receive 600 IU of natural-source vitamin E on alternate days or placebo, and were followed up for an average of 10.1 years.

The researchers found with the vitamin E group, there was no significant effect on major cardiovascular events, on the incidences of heart attack or stroke, as well as ischemic or hemorrhagic stroke. For cardiovascular death, there was a 24 percent reduction. There was no significant effect on the incidences of total cancer or breast, lung, or colon cancers. Cancer deaths also did not differ significantly between groups. There was no significant effect of vitamin E on total death.

"In conclusion, the WHS does not support recommending vitamin E supplementation for CVD or cancer prevention among healthy women. This large trial supports current guidelines stating that use of antioxidant vitamins is not justified for CVD risk reduction. ...The WHS findings should be viewed in the context of the available randomized evidence, as well as data that should be available over the next several years from ongoing trials, including the Physicians' Health Study, which will provide data on primary prevention in men. At present, in the primary prevention of CVD and cancer, therapeutic lifestyle changes including a healthy diet and control of major risk factors remain important clinical and public health strategies," the authors conclude.
(JAMA. 2005;294:56-65. Available pre-embargo to the media at www.jamamedia.org)

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

EDITORIAL: VITAMIN E AND CARDIOVASCULAR HEALTH

In an accompanying editorial, Rita F. Redberg, M.D., M.Sc., of the University of California, San Francisco, discusses the study by Lee et al.

"Perhaps it is time to consider devoting some of the limited resources necessary to perform randomized controlled trials to other pressing, unanswered questions in the field of cardiovascular disease prevention in women. With the publication of the WHS vitamin E results, it is time to redirect attention to interventions that have been shown to or could provide significant benefit."

" ...vitamin E enters the category of therapies that were promising in epidemiologic and observational studies but failed to deliver in adequately powered randomized controlled trials. As in other studies, the 'healthy user' bias must be considered, i.e., the healthy lifestyle behaviors that characterize individuals who care enough about their health to take various supplements are actually responsible for the better health, but this is minimized with the rigorous trial design. It is estimated that almost 1 million preventable deaths per year are due to smoking, poor diet, and physical inactivity. Perhaps the most important outcome of the WHS reports will be greater recognition that it is time to concentrate on teaching nutrition, promoting regular physical activity, and strongly encouraging smoking cessation and particularly increasing outreach to women of racial and ethnic minorities," Dr. Redberg writes. "[These] are underused but proven prevention strategies for heart disease. Interestingly, these positive lifestyle changes are also associated with the prevention of cancer and Alzheimer disease."
(JAMA. 2005;294:107-109. 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.

Go back to the top.

Embargoed for Release: 3 p.m. CT, Tuesday, July 5, 2005
Media Advisory: To contact Ian M. Thompson, M.D., call Will Sansom at 210-567-2579.

STUDY EXAMINES ACCURACY OF PSA VALUES FOR DETECTING PROSTATE CANCER

CHICAGO—A new study indicates there is no specific PSA value that has both high sensitivity and high specificity for monitoring healthy men for prostate cancer, but rather there is a continuum of prostate cancer risk at all values of PSA, according to a study in the July 6 issue of JAMA.

One of the most common cancer screening activities in the United States is the measurement of prostate-specific antigen (PSA) levels for the early detection of prostate cancer, according to background information in the article. In 2001, approximately 75 percent of men in the United States aged 50 years and older reported that they had previously undergone PSA screening and 54 percent have reported regular PSA screening. In general, prostate biopsy has not been recommended unless PSA levels exceed a threshold value, generally 4.0 ng/mL, with slightly lower values recommended recently by some researchers. Prostate cancer screening with PSA has been controversial, as no studies have proven that this strategy reduces death from prostate cancer.

Ian M. Thompson, M.D., of the University of Texas Health Science Center at San Antonio, and colleagues conducted a study to determine the effectiveness of PSA testing by estimating the receiver operating characteristic (ROC) curve (a measure of diagnostic accuracy) for PSA. The researchers analyzed data from the Prostate Cancer Prevention Trial, a randomized, prospective study conducted from 1993 to 2003 at 221 U.S. centers. Participants were 18,882 healthy men aged 55 years or older without prostate cancer and with PSA levels less than or equal to 3.0 ng/mL and normal digital rectal examination results, followed up for 7 years with annual PSA measurement and digital rectal examination. If PSA level exceeded 4.0 ng/mL or rectal examination result was abnormal, a prostate biopsy was recommended. After 7 years of study participation, an end-of-study prostate biopsy was recommended in all cancer-free men.

For this analysis, the authors included 8,575 men in the placebo group of the trial who had at least 1 PSA measurement and digital rectal exam in the same year. Of these men, 5,587 (65.2 percent) had at least 1 biopsy, and of these, 1,225 (21.9 percent) were diagnosed with prostate cancer.

The researchers found that for detecting any prostate cancer, PSA cutoff values of 1.1, 2.1, 3.1, and 4.1 ng/mL yielded sensitivities of 83.4 percent, 52.6 percent, 32.2 percent, and 20.5 percent, and specificities of 38.9 percent, 72.5 percent, 86.7 percent, and 93.8 percent, respectively.

"... a clear-cut decision rule for prostate biopsy based on PSA values would be challenging to derive from these data. On one hand, the commonly used cutoff value of 4.1 ng/mL would have a 6.2 percent false-positive rate (1-specificity) but would detect only 20.5 percent of cancer cases (sensitivity). To improve cancer detection, the cutoff could be lowered to 1.1 ng/mL, thus detecting 83.4 percent of cancer cases, but would subject 61.1 percent of men without cancer to prostate biopsy. The recently recommended cutoff of 2.6 ng/mL would detect only 40.5 percent of cancer cases. ...there is no single cutoff that would simultaneously yield both high sensitivity and high specificity," the authors write.

"The delay in diagnosis of high-grade tumors until PSA levels exceed current threshold 'normal' values could also explain why there is a 35 percent risk of subsequent treatment after radical prostatectomy, presumably due to disease recurrence. However, lowering the threshold would have 2 consequences: increased biopsy rates and the possibility of increased detection and treatment of biologically inconsequential cancers. Currently, men in the United States have a 17.3 percent lifetime risk of prostate cancer diagnosis, while the lifetime risk of prostate cancer death is 3 percent," the researchers write.

"The implications of this analysis are substantial. Prior to clinical use of biomarkers or other tests for cancer screening, properly designed validation studies are essential. A multi-step process for validation is currently used by the Early Detection Research Network of the National Cancer Institute. While prostate cancer is not unique, it has a variable natural history, ranging from markedly aggressive to indolent. Consideration should be given to the development of biomarkers that incorporate disease prognosis. Finally, it will be a challenge to the medical community to change the long-held notion that there is a 'normal' PSA level. Patients and health care professionals must be re-educated that there is a continuum of risk and no clearly defined PSA cutpoint at which to recommend biopsy. It will be the patient, in concert with his health care professional, who will ultimately have to weigh the sensitivity-specificity tradeoffs in combination with the uncertain natural history of the disease to determine whether further evaluation with a prostate biopsy is appropriate," the authors conclude.
(JAMA. 2005;294:66-70. Available pre-embargo to the media at www.jamamedia.org)

Editor's Note: This study was supported in part by Public Health Service grants from the National Cancer Institute.

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, July 5, 2005
Media Advisory: To contact Susan R. Davis, M.D., Ph.D., email: susan.davis{at}med.monash.edu.au.

NO LINK FOUND BETWEEN LOW ANDROGEN LEVELS AND LOW SEXUAL FUNCTION IN WOMEN

CHICAGO—No single androgen (sex hormone) level was found to be predictive of low sexual function in women, according to a study in the July 6 issue of JAMA.

Sexual dysfunction, primarily low libido, is common among women, with prevalences of 8 percent to 50 percent, according to background information in the article. Although multiple psychosocial and health factors contribute to low sexual desire and arousal, it has been proposed that androgen levels are significant independent determinants of sexual behavior in women. It is widely believed that a low serum free testosterone level is the diagnostic marker for the cluster of symptoms described as characterizing "female androgen insufficiency" based on therapeutic trials, and expert opinion. However, evidence that a low serum testosterone level distinguishes women with low sexual function from others, is lacking.

Susan R. Davis, M.D., Ph.D., of Monash Medical School, Alfred Hospital, Victoria, Australia, and colleagues conducted a study to determine if low self-reported sexual function is associated with low serum androgen levels. The study included 1,423 women aged 18 to 75 years who were randomly recruited from April 2002 to August 2003. Women were excluded from the analysis if they were younger than 45 years and using oral contraception. Women were surveyed with the Profile of Female Sexual Function (PFSF) and serum levels of total and free testosterone, androstenedione (an androgenic steroid), and dehydroepiandrosterone sulfate (DHEAS, a natural steroid hormone) were measured.

The researchers write: "We found no evidence of associations between low scores for any of the sexual domains evaluated and low serum total and free testosterone levels. In contrast, we observed significant associations between low sexual desire, arousal, and responsiveness in younger women [aged 18 to 44 years] and low responsiveness in older women [aged 45 years or older] and low serum DHEAS level relative to age."

"In addition to demonstrating that the measurement of testosterone is not useful for the diagnosis of the proposed female androgen insufficiency syndrome, our findings also do not support a diagnostically useful role for the measurement of DHEAS. This is because despite the increased likelihood that women with low sexual function have a low DHEAS level, the majority of women with a low DHEAS level did not report low sexual function," the authors write.

"Our results are not in conflict with testosterone being used pharmacologically to treat [abnormally inactive] sexual desire disorder, nor do they provide support for efficacy of DHEA therapy. Rather, our data, taken together with what is already known about the intracrine [a type of hormone function] physiology, suggest that sex steroids influence female sexual function, but that there is no serum androgen level that defines female androgen insufficiency. The measurement of serum testosterone, free testosterone, or DHEAS in individuals presenting with low sexual function is not informative and levels of these hormones should not be used for the purpose of diagnosing androgen insufficiency in women," the researchers conclude.
(JAMA.2005;294:91-96. Available pre-embargo to the media at www.jamamedia.org)

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

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

VIDEO: Windows Media | Quicktime

VITAMIN E SHOWN NOT TO PREVENT HEART DISEASE OR CANCER IN HEALTHY WOMEN – ASPIRIN SHOWN NOT TO PREVENT CANCER IN HEALTHY WOMEN

VIDEO:
B-ROLL
Pill container
Sandra taking aspirin

AUDIO:
THESE PILLS ARE PART OF A STUDY OF NEARLY 40-THOUSAND HEALTHY WOMEN. MANY OF THE WOMEN, INCLUDING SANDRA DELANEY, TOOK 100 MILLIGRAMS OF ASPIRIN ONE DAY, 600 INTERNATIONAL UNITS OF VITAMIN E THE NEXT, FOR ABOUT TEN YEARS.

VIDEO:
SOT/FULL
@ :14
Super: Sandra Delaney
Study participant
Runs :14

AUDIO:
"They were talking a lot in the media about, you know, vitamin E and how it might affect people with heart disease and how it could be beneficial, and I know my own physician was recommending I be on a low dose of aspirin anyway."

VIDEO:
B-ROLL
Sandra taking vitamin E
GFX/JAMA COVER

AUDIO:
...BECAUSE ASPIRIN HAS BEEN SHOWN TO HELP PREVENT HEART DISEASE. BUT RESEARCHERS WANTED TO KNOW IF IT COULD ALSO PREVENT CANCER, AND IF VITAMIN E COULD PREVENT CANCER OR HEART DISEASE. THEIR FINDINGS, FROM THE WOMEN’S HEALTH STUDY, APPEAR IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.

VIDEO:
SOT/FULL
@ :44
Super: I-Min Lee, MBBS, ScD
Brigham and Women’s Hospital
Runs :11

AUDIO:
"In the women’s health study, we found that vitamin E supplementation had no overall benefit in terms of preventing heart disease and cancer in healthy women."

VIDEO:
SOT/FULL
@ :54
Super: Nancy Cook, ScD
Brigham and Women’s Hospital
Runs :03

AUDIO:
"Overall, we found no protective benefit of aspirin on cancer in general."

VIDEO:
B-ROLL
Lung cancer x-ray
Vitamin E on store shelves
Drs. Cook and Lee discussing data

AUDIO:
ASPIRIN WAS ASSOCIATED WITH A SLIGHT REDUCTION IN LUNG CANCER, AND VITAMIN E LINKED TO A SLIGHT REDUCTION IN HEART DISEASE DEATHS. BUT THE RESEARCHERS SAY THOSE FINDINGS STILL NEED FURTHER STUDY. IN THE MEANTIME...

VIDEO:
SOT/FULL
I-Min Lee, MBBS, ScD
Brigham and Women’s Hospital
Runs :10

AUDIO:
"The data from the Women’s Health Study do not support recommending vitamin E in preventing cardiovascular disease or cancer in healthy women."

VIDEO:
B-ROLL
Sandra with pills

AUDIO:
THE SAME GOES FOR LOW-DOSE ASPIRIN AND CANCER. STILL, SANDRA SAYS SHE WILL CONTINUE TO TAKE BOTH THE LOW-DOSE ASPIRIN AND THE VITAMIN E.

VIDEO:
SOT/FULL
Sandra Delaney
Study participant
Runs :03

AUDIO:
SOT/FULL
Sandra Delaney
Study participant
Runs :03

VIDEO:
B-ROLL
Drs. Cook and Lee discussing data

AUDIO:
BUT THE RESEARCHERS HAVE THIS ADVICE FOR WOMEN INTERESTED IN PREVENTING HEART DISEASE AND CANCER.

VIDEO:
SOT/FULL
Nancy Cook, ScD
Brigham and Women’s Hospital
Runs :06 (cover exercise and continue through sig out)

AUDIO:
"It would be much easier to just take a pill but I think everyone has to buckle down and lead a healthy lifestyle, not smoke, eat right and exercise."

VIDEO:
B-ROLL
Woman exercising in gym

AUDIO:
THIS IS MAVIS PRALL WITH THE JAMA REPORT.