© 2004 by Oxford University Press
© 2004 Oxford University Press
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In Brief
Political Questions Inappropriate When Asked of Appointees, Panel Concludes
Potential candidates for government scientific and technical advisory committees should not be asked to provide nonrelevant information—such as voting record, political affiliation, or their positions on particular policies—and should instead be selected on the basis of their knowledge, expertise, and credentials, a National Academies committee has concluded.
The ad hoc committee to the Committee on Science, Engineering, and Public Policy was charged with preparing a third report (previous reports were published in 1992 and 2000) examining the most senior science and technology positions in the federal government. They also examined, for the first time, the appointments of scientists, engineers, and health professionals to the roughly 1,000 federal advisory committees that address science-based policy or the review of research proposals.
The committee concluded that it is inappropriate for people nominated to serve on federal advisory committees to be asked nonrelevant information and that their selection should be based on their scientific and technical knowledge, their credentials, and their professional and personal integrity. However, asking these people to reveal potential sources of bias would help other committee members to weigh their advice.
The report, "Science and Technology in the National Interest: Ensuring the Best Presidential and Federal Advisory Committee Science and Technology Appointments," is available online from the National Academies Press at http://www.nap.edu/catalog/11152.html.
Tarceva Wins Approval From FDA
The U.S. Food and Drug Administration has approved erlotinib (Tarceva) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer.
Erlotinib, a tyrosine kinase inhibitor, was shown to improve survival in these patients; a randomized trial of 731 patients found that patients on the drug survived an average of 6.7 months compared with 4.7 months for patients on placebo. Researchers are not certain how the drug works, but it was designed to block the tyrosine kinase associated with the epidermal growth factor receptor (EGFR).
HPV Vaccine Effective for Preventing Infections, Related Cervical Abnormalities
A phase II trial of a vaccine designed to protect against two types of human papillomavirus (HPV) has found that the vaccine is safe and effective for preventing infections of the virus and cervical abnormalities associated with infection.
In the November 13 issue of the Lancet, Diane M. Harper, M.D., of the Norris Cotton Cancer Center in Lebanon, N.H., and colleagues report the results of a phase II trial of a vaccine for HPV16, which is responsible for more than 60% of cervical cancers, and HPV18, which is responsible for about 10% of cervical cancers. In the trial, 1113 women ages 15 to 25 from North America and Brazil received either a series of three vaccinations over 6 months or a placebo and were then followed for 27 months.
The vaccine was 91.6% effective against incident infection and 100% effective against persistent infection. Among all the women in the study who received at least one dose of the vaccine, the vaccine was 95.1% effective against persistent infection and 92.9% effective against abnormalities associated with HPV infection that can lead to cervical cancer. The issue of whether the vaccine protects against cervical cancer needs to be addressed in large-scale trials with long-term follow-up, the authors say. Recruitment for a larger phase III trial of the vaccine is currently under way.
See also News, Vol. 95, No. 2, p. 102, "Success of Vaccine Offers Promise of Cervical Cancer Prevention."
Elderly Under-Represented in Cancer Trials
Elderly patients account for 60% of the total U.S. population with cancer but only 36% of patients enrolled in cancer trials, according to a new study.
In the United States, people age 65 and older account for about 60% of all new cancer cases and 70% of cancer-related deaths, numbers that are expected to increase as life expectancy increases. However, studies have found that the elderly are often under-represented in clinical trials of new cancer treatments.
In the November 15 issue of the Journal of Clinical Oncology, Lilia Talarico, M.D., of the U.S. Food and Drug Administration, and colleagues report the results of an analysis of the age-related enrollment of cancer patients into trials of new drugs or indications that had been approved by the FDA between 1995 and 2002. During this time, people 65 and older accounted for 36% of cancer trial participants; 70 and older, 20%; and 75 and older, 9%; those same age groups represent 60%, 46%, and 31%, respectively, of the U.S. cancer population.
Only the participation of elderly women with breast cancer in trials of hormonal therapy for both early and advanced disease was consistent with the age distribution of their disease in the general population. The researchers suggest that elderly patients may be excluded from studies because of health limitations and concerns about their ability to tolerate chemotherapy.
ASCO Recommends Aromatase Inhibitors for Adjuvant Therapy for Breast Cancer
Postmenopausal women with hormone receptor-positive breast cancer should receive adjuvant therapy that includes an aromatase inhibitor, concludes a technology assessment from the American Society of Clinical Oncology.
The assessment of several large clinical trials concluded that adjuvant therapy for breast cancer should include one of three types of aromatase inhibitors—anastrozole (Arimidex), letrozole (Femara), and exemestane (Aromasin)—either following 2 to 5 years of tamoxifen therapy or alone for 5 years. However, it is not yet known if the three drugs can be used interchangeably or if it is safe to use them for more than 5 years. Data suggest that aromatase inhibitors may reduce a woman's chance of blood clots and uterine cancer compared with tamoxifen but increase the risk of fractures and osteoporosis.
See also News, Vol. 94, No. 7, p. 474, "Upstaging Tamoxifen? New Classes of Drugs Emerging for Breast Cancer.
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