© 2005 Oxford University Press
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In Brief
Routine Testing for BRCA Mutations Not Recommended for General Public
Primary care physicians should not refer all women for genetic testing for BRCA1 and BRCA2 mutations and instead refer only those women whose family history puts them at particularly high risk for these mutations, according to new guidelines from the U.S. Preventive Services Task Force that appear in the September 6 issue of the Annals of Internal Medicine.
Women of Ashkenazi Jewish descent or those who have specific patterns of family history—as determined using standard risk assessment tools—have a higher likelihood of testing positive for a BRCA mutation than women in the general public. After conducting a review of the literature, the task force determined that testing the general public would put these women at too high a risk of the potential harms of genetic testing, including false-positive results.
Warning Issued on Trastuzumab's Potential Cardiovascular Risks
Genentech has issued a new warning regarding cardiotoxicity from its breast cancer drug trastuzumab (Herceptin) following the company's receipt of safety data from the National Surgical Adjuvant Breast and Bowel Project study B-31.
B-31, a randomized phase III trial, had studied the drug in more than 2,000 women with operable HER-2–positive breast cancer. In the study, the 3-year cumulative incidence of congestive heart failure and cardiac death was 4.1% among patients given trastuzumab compared with 0.8% among patients in the control group.
The B-31 trial and a similar trial, the North Central Cancer Treatment Group study N9831, are evaluating the addition of trastuzumab to standard chemotherapy. Safety analyses of both trials are ongoing, the company said.
Final Ethics Rules Announced by NIH
The National Institutes of Health has announced the final version of its new ethics regulations, keeping in place a ban on all outside consulting but softening restrictions on stock ownership and other activities.
The first version of the regulations, which went into effect February 3, placed all NIH employees under strict restrictions on consulting, stock ownership, and accepting awards and honoraria from organizations that do business with the agency. However, some staff members protested that the regulations went too far.
The new rules keep in place restrictions for all staff on consulting with organizations, such as pharmaceutical and biotechnology companies, that work with NIH, but now only senior employees and their spouses and minor children will have to abide by limits for stock ownership in companies that do business with the agency. These employees will be required to divest themselves of holdings in excess of $15,000 per company. In addition, all NIH employees will be allowed, contingent upon prior approval, to receive monetary awards for major scientific prizes, participate in activities with professional and scientific organizations, serve on data and safety monitoring boards, participate in the review of scientific grants, and engage in other compensated academic activities, such as writing, editing, and giving lectures.
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