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, June 20, 2006)
JAMA NEWS RELEASES
STATIN USE ASSOCIATED WITH REDUCED RISK OF COMMON TYPE OF CATARACT
PARTICIPATION IN PHARMACEUTICAL-SPONSORED CLINICAL TRIALS DOES NOT APPEAR TO AFFECT PHYSICIAN’S ADHERENCE TO TREATMENT GUIDELINES, BUT MAY INFLUENCE WHICH MEDICATION IS PRESCRIBED
PREVIOUSLY RELEASED
MAJOR STUDY EVALUATES BENEFITS AND RISKS OF TAMOXIFEN AND RALOXIFENE FOR REDUCING THE RISK OF BREAST CANCER
JAMA REPORT (VIDEO NEWS RELEASE SCRIPT)
VIDEO: Windows Media | Quicktime
OLDER WOMEN MAY SOON HAVE NEW MEDICATION OPTION FOR BREAST CANCER PREVENTION
INFORMATION CONTAINED IN THESE NEWS RELEASES IS PROTECTED BY COPYRIGHT. JOURNAL ATTRIBUTION IS REQUIRED.
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
TV Note: This week's JAMA video news release examines the benefits and risks of tamoxifen and raloxifene for reducing the risk of breast cancer. The release will be fed Tuesday, June 20, 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.
Embargoed for Release: 3:00 p.m. CT, Tuesday, June 20, 2006
Media Advisory: To contact Barbara E. K. Klein, M.D., M.P.H., call Sayward Proctor at 608-265-7344.
STATIN USE ASSOCIATED WITH REDUCED RISK OF COMMON TYPE OF CATARACT
CHICAGO—The use of statins is linked with a lower incidence of nuclear cataract, the most common type of age-related cataract, according to a study in the June 21 issue of JAMA.
Statins are widely used to decrease serum cholesterol for cardiovascular disease prevention. Statins have also been shown to have antioxidant activity. Oxidative stress (a condition in which antioxidant levels are lower than normal) has been thought to be a risk factor for age-related cataract, particularly nuclear cataract (the most common type of age-related cataract, which occurs in the center of the lens). Some evidence has suggested an association between nutritional intake of antioxidants and age-related cataract, according to background information in the article.
Barbara E. K. Klein, M.D., M.P.H., of the University of Wisconsin School of Medicine and Public Health, Madison, and colleagues analyzed data from the Beaver Dam Eye Study to determine if statin use is associated with a reduced risk of age-related cataract. The analysis included 1,299 persons who were examined as part of the study in 1998-2000 and were deemed to be at risk of developing nuclear cataract within 5 years.
A total of 210 persons developed incident nuclear cataract in the interval from 1998-2000 to 2003-2005. The five-year incidence of nuclear cataract was 12.2 percent in statin users compared with 17.2 percent in nonusers; the odds of developing cataract were 40 percent lower for statin users after adjusting for several factors. Because smoking and diabetes increase risk of nuclear cataract, the authors analyzed results in never smokers without diabetes, and found the odds of developing nuclear cataract was 60 percent lower among statin users after adjusting for other factors. The incidence of two other types of cataracts, cortical and posterior subcapsular cataracts, did not differ significantly between statin users and nonusers.
To further explore the relationship between statin use and nuclear cataract, the authors suggest that clinical trials of statins used for lipid lowering should assess nuclear cataract. In addition, they state “further study of the relationship of cataract and statin use is needed in which each type of cataract is considered individually. Further follow-up of our cohort, with anticipated increase in number of persons with cataract and wider use of statins, will permit us to evaluate whether our finding persists.”
(JAMA. 2006;295:2752-2758. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: The National Eye Institute provided funding for the entire study; Research to Prevent Blindness, New York, N.Y., provided further additional support for data analyses.
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, June 20, 2006
Media Advisory: To contact Morten Andersen, M.D., Ph.D., email: mandersen{at}health.sdu.dk. To contact editorial co-author Bruce M. Psaty, M.D., Ph.D., call Clare Hagerty at 206-685-1323.
PARTICIPATION IN PHARMACEUTICAL-SPONSORED CLINICAL TRIALS DOES NOT APPEAR TO AFFECT PHYSICIAN’S ADHERENCE TO TREATMENT GUIDELINES, BUT MAY INFLUENCE WHICH MEDICATION IS PRESCRIBED
CHICAGO—Physicians who participated in a pharmaceutical-sponsored clinical trial involving asthma medications maintained adherence to treatment guidelines but were more likely to prescribe the sponsor’s drugs, according to a study in the June 21 issue of JAMA.
Pharmaceutical companies are frequently involved in clinical trials in general practice, and this may trigger an increase in the use of the sponsoring company’s products due to the physicians’ experience with these products. This effect may be further strengthened by close physician-company cooperation, which may create physician loyalty toward the company. The effect of participation in company-sponsored studies on drug preferences has not been evaluated in primary care.
Morten Andersen, M.D., Ph.D., of the University of Southern Denmark, Odense, and colleagues investigated the effects of physicians participating in a pharmaceutical company-sponsored clinical trial that was aimed at improving patients’ use of asthma medicine. The study compared 10 practices that were conducting the trial on asthma medicine with 165 control (non–trial-conducting) practices in Funen County, Denmark. The study included 5,439 patients treated with asthma drugs from the trial-conducting practices and 59,574 patients from the control practices.
The researchers found that the prevalence of inhaled steroid use among asthma patients increased from 68.5 percent at baseline to 72.9 percent during the second observation year in trial-conducting practices and from 69.1 percent to 73.3 percent in control (non–trial-conducting) practices. There was no impact of participating in the trial on physicians’ adherence to international treatment guidelines. Both trial-conducting and control practices had a gradually increased use of the trial sponsor’s inhaled corticosteroids, from 74.8 percent to 81.5 percent in trial-conducting practices and from 73.6 percent to 76.6 percent in control practices. Trial-conducting practices were 26 percent more likely than control practices to have the trial sponsor’s inhaled corticosteroids used. The trial sponsor’s share of the total prescribed volume of asthma drugs increased in trial-conducting practices compared with control practices by 6.7 percent.
“Our study confirms the hypothesis that physician involvement in clinical trials is a powerful tool for influencing company-specific drug preferences. Several mechanisms may be responsible, including setting up a gift relationship by payment to the trial-conducting physicians. If we had access to information on the costs of the trial, it would have been possible to evaluate if these trial costs were counterbalanced by the revenue from the trial sponsor’s increased market share. Whether conducting a clinical trial can lead to minor improvements in guideline adherence can only be addressed in large-scale studies,” the authors write.
(JAMA. 2006;295:2759-2764. 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: CLINICAL TRIAL INVESTIGATORS AND THEIR PRESCRIBING PATTERNS
In an accompanying editorial, Bruce M. Psaty, M.D., Ph.D., of the University of Washington, Seattle and Drummond Rennie, M.D., of the University of California, San Francisco, and Deputy Editor, JAMA, comment on the findings of Andersen et al.
“With the advent of national drug prescription data from Medicare Part D, the association between investigator status and prescribing behavior may emerge as the subject of a new genre of studies on research into physician-industry interactions in the United States. Practicing physicians and disinterested scientists need to recognize and acknowledge these forms of potential influence by the pharmaceutical industry. Agreeing to work as an investigator in industry-sponsored trials may represent a commitment to an effort that is more or less a scientific endeavor and, at the same time, a marketing initiative.”
“More importantly, the scientific rationale for launching thousands of small short-term trials remains unclear. The health of the public would be better served by the conduct of fewer small short-term studies and more well-designed large long-term trials, such as the Women’s Health Initiative (WHI) and the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), that fully address the health risks and benefits of pharmacological therapies used for chronic conditions. The findings from such studies provide a sensible evidence base for both clinical practice and industry marketing.”
(JAMA. 2006;295:2787-2790. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: This research was supported in part by grants from the National Heart, Lung, and Blood Institute, the National Institute on Aging, and the American Heart Association. Dr. Psaty reported receiving compensation for expert testimony on phenylpropanolamine and on cerivastatin.
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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PLEASE NOTE: THESE STUDIES WERE PREVIOUSLY RELEASED (JUNE 5, 2006)
Embargoed for Release: 3:00 p.m. CT, Tuesday, June 20, 2006
Media Advisory: To contact Victor G. Vogel, M.D., M.H.S., or Stephanie R. Land, Ph.D., call Clare Collins at 412-352-2886. To contact editorial co-author William J. Gradishar, M.D., call Elizabeth Crown at 312-503-8928.
MAJOR STUDY EVALUATES BENEFITS AND RISKS OF TAMOXIFEN AND RALOXIFENE FOR REDUCING THE RISK OF BREAST CANCER
CHICAGO—Raloxifene and tamoxifen are both effective in reducing the risk of invasive breast cancer, but each has potential disease and quality of life side effects that women and their physicians will need to consider, according to two reports and an editorial published in the June 21 issue of JAMA.
Tamoxifen is a selective estrogen receptor modulator (SERM) that has been used to treat both early and advanced breast cancer for more than three decades, according to background information in the article. Raloxifene is a second-generation SERM currently used as a medication for the prevention and treatment of osteoporosis. But clinical trials have shown it may have a role in reducing the risk of invasive breast cancer in postmenopausal women.
Victor G. Vogel, M.D., M.H.S., from Magee-Womens Hospital, University of Pittsburgh School of Medicine, and colleagues from The National Surgical Adjuvant Breast and Bowel Project (NSABP), conducted a randomized clinical trial (Study of Tamoxifen and Raloxifene or STAR trial) at nearly 200 clinical centers throughout North America. Patients were 19,747 postmenopausal women with an average age of 58.5 years with an increased five-year breast cancer risk. The study patients were randomized to receive oral tamoxifen (20 mg/day) or raloxifene (60 mg/day) over five years.
“There were 163 cases of invasive breast cancer in women assigned to tamoxifen and 168 in those assigned to raloxifene (incidence, 4.30 per 1,000 vs. 4.41 per 1,000),” according to the study authors. There were fewer cases of noninvasive breast cancer in the tamoxifen group (57 cases) than in the raloxifene group (80 cases), while there were 36 cases of uterine cancer with tamoxifen and 23 with raloxifene; however, neither of these differences were statistically significant. No differences were found for other invasive cancer sites, for ischemic heart disease events, or for stroke. Thromboembolic events (such as blood clots in the lung or deep veins) occurred less often in the raloxifene group and there were fewer cataracts and cataracts surgeries in that group. The number of osteoporotic fractures in the two groups was similar. There were no differences in the total number of deaths or in causes of death.
The authors suggest that primary care physicians, who are the most involved in preventive care, have not prescribed tamoxifen because it is viewed as a toxic cancer drug. “In contrast, raloxifene is well known to the primary care community and is widely prescribed for the prevention and treatment of osteoporosis in postmenopausal women. More than 500,000 women in the United States are currently taking raloxifene, the majority of whom are older and at lower risk of breast cancer than are the women in the STAR trial.”
In conclusion, the researchers write: “This trial confirms the previously reported benefit of raloxifene in reducing the risk of invasive breast cancer and indicates that raloxifene is as active as tamoxifen in this regard. If raloxifene is approved by the Food and Drug Administration for the prevention of breast cancer, primary care physicians may be more willing, given their experience with raloxifene, to prescribe it for breast cancer chemoprevention than they have been to prescribe tamoxifen.”
(JAMA. 2006;295:2727-2741. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see JAMA paper for authors’ financial disclosures. The study was supported by Public Health Service grants from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, and by AstraZeneca Pharmaceuticals and Eli Lilly and Co.
PATIENT-REPORTED SYMPTOMS AND QUALITY OF LIFE
In a related paper, Stephanie R. Land, Ph.D., from the University of Pittsburgh and colleagues from the NSABP STAR trial compared differences in patient-reported outcomes — focused on quality of life, and symptoms in the STAR participants. The patient-reported outcomes were evaluated with standardized surveys.
“No significant differences existed between the tamoxifen and raloxifene groups in patient-reported outcomes for physical health, mental health, and depression, although the tamoxifen group reported better sexual function,” the authors found. “Although mean (average) symptom severity was low among these postmenopausal women, those in the tamoxifen group reported more gynecological problems, vasomotor symptoms, leg cramps, and bladder control problems, whereas women in the raloxifene group reported more musculoskeletal problems, dyspareunia (pain during sexual intercourse), and weight gain.”
“The NSABP’s STAR trial, with its large-scale symptom evaluation and well-powered quality of life substudy, provides a comprehensive, detailed view of the patient experience using raloxifene and tamoxifen. Both of these agents are indicated for prevention in large populations, so these results can be widely used as tools in decision making or in helping a woman anticipate and cope with the sequelae of her chosen agent,” the authors conclude.
(JAMA. 2006;295:2742-2751. Available pre-embargo to the media at www.jamamedia.org)
Editor's Note: Please see JAMA study for authors’ financial disclosures. Please see editor’s note above for study funding information.
EDITORIAL: IS RALOXIFENE THE RISING STAR?
“This year, more than 200,000 women in the United States will be diagnosed as having invasive breast cancer,” William J. Gradishar, M.D., from the Northwestern University Feinberg School of Medicine, and David Cella, Ph.D., from the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, write in an accompanying editorial. “The past 20 years of research translating an understanding of basic biology into therapeutics has led to major improvements in the survival and quality of life of patients who carry a diagnosis of breast cancer.”
“The results of the STAR trial offer a pragmatic stepping stone to the next prevention trial in breast cancer. Raloxifene, if not superior to tamoxifen, may be more acceptable to clinicians presenting the option of a preventive drug.”
“The breast cancer chemoprevention sky now includes 2 shining STARs – tamoxifen and raloxifene. Although neither is a supernova, their benefits include prevention of breast cancer in postmenopausal women at increased risk and, in the case of raloxifene, reduction of fractures related to osteoporosis. Perhaps because the clear benefits are limited to these end points, the relatively modest adverse event profiles and minimally impaired quality of life experienced by these women still may not be enough to convince primary care physicians to be more aggressive than they have been to date in breast cancer chemoprevention.”
(JAMA. 2006;295:2784-2786. 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
OLDER WOMEN MAY SOON HAVE NEW MEDICATION OPTION FOR BREAST CANCER PREVENTION
VIDEO:
B-ROLL
Tamoxifen pills in hand
Both pills/bottles
Raloxifene pills in hand
AUDIO:
TAMOXIFEN (tah-MOX-ih-fen) CAN REDUCE A WOMAN’S RISK OF BREAST CANCER BY ABOUT FIFTY PERCENT. SOON, OLDER WOMEN MAY HAVE ANOTHER DRUG OPTION FOR BREAST CANCER PREVENTION. IT’S AN OSTEOPOROSIS DRUG.
VIDEO:
SOT/FULL
@ :11
Super: Victor Vogel, M.D., M.H.S.
U. of Pittsburgh School of Medicine
Runs :11
AUDIO:
“What we found was that the osteoporosis drug, raloxifene, was equally effective to the breast cancer treatment drug tamoxifen, at reducing the risk of life-threatening breast cancer.”
VIDEO:
B-ROLL
Dr. Vogel looking at charts
With nurses in office
AUDIO:
DR. VICTOR VOGEL OF UNIVERSITY OF PITTSBURGH AND COLLEAGUES STUDIED NEARLY TWENTY-THOUSAND WOMEN AT HIGH RISK OF BREAST CANCER, WHO HAD ALREADY REACHED MENOPAUSE. HE FOUND THAT RALOXIFENE (ruh-LOX-ih-feen)HAD ADDED BENEFITS.
VIDEO:
SOT/FULL Victor Vogel, M.D., M.H.S.
U. of Pittsburgh School of Medicine
Runs :11
AUDIO:
“Compared to tamoxifen, raloxifene was safer in terms of causing fewer uterine cancers and fewer life-threatening blood clots.”
VIDEO:
B-ROLL
Dr. Land getting binder from shelf
GFX/JAMA COVER
AUDIO:
DR. STEPHANIE LAND AND HER COLLEAGUES STUDIED THE QUALITY-OF-LIFE ISSUES ASSOCIATED WITH THE TWO DRUGS. BOTH STUDIES APPEAR IN JAMA, THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION.
VIDEO:
SOT/FULL
@ :54
Super: Stephanie Land, Ph.D.
U. of Pittsburgh School of Public Health
Runs :11
AUDIO:
“What women are telling us is that although there are side effects with both of these treatments, that the side effects did not impact their overall quality of life in a negative way.”
VIDEO:
Full screen graphic over pill bottles
| Tamoxifen |
Raloxifene |
| Leg cramps |
Muscle and bone aches |
| Gynecological problems |
Pain during intercourse |
| Bladder control problems |
Weight gain |
AUDIO:
THERE WERE SOME SIDE EFFECTS IN BOTH GROUPS. WOMEN ON TAMOXIFEN HAD MORE LEG CRAMPS, GYNECOLOGICAL AND BLADDER CONTROL PROBLEMS. WOMEN ON RALOXIFENE HAD MORE MUSCLE AND BONE ACHES, PAIN DURING SEXUAL INTERCOURSE AND WEIGHT GAIN.
VIDEO:
SOT/FULL
@ 1:18
Super: Marion Taube
Took raloxifene
Runs :11
AUDIO:
“I don’t think I had any side effects. Possibly leg cramping, but I don’t know if that was related to the raloxifene or unrelated.”
VIDEO:
B-ROLL
Marion and husband looking at photos
AUDIO:
MARION TAUBE (TAU-bee) TOOK RALOXIFENE FOR FIVE YEARS AS PART OF THE STUDIES.
VIDEO:
SOT/FULL
Marion Taube
Took raloxifene
Runs :08
AUDIO:
“We have 8 granddaughters, a daughter and 3 daughters-in-law and I had that in my mind when I participated in the study.”
VIDEO:
B-ROLL
Marion and husband looking at photos
cutaways of photos
AUDIO:
THE RESEARCHERS AGREE THAT THE STUDIES ARE GOOD NEWS FOR WOMEN TODAY AND IN THE FUTURE.
VIDEO:
SOT/FULL
Stephanie Land, Ph.D.
U. of Pittsburgh School of Public Health
Runs :09
AUDIO:
“The overall and exciting news from this study is that as soon as raloxifene has also been approved for the prevention of breast cancer women will have two choices.”
VIDEO:
B-ROLL
Dr. Vogel looking at files
Raloxifene bottle/pouring pills into hand
AUDIO:
BUT DR. VOGEL SAYS FOR OLDER WOMEN, RALOXIFENE MAY BE THE DRUG OF CHOICE. THIS IS MAVIS PRALL WITH THE JAMA REPORT.
