- Avastin Shouldn't Be Used to Treat Breast Cancer: FDA
- No Need to Fear Synthetic Biology: Bioethics Commission
- Genetic Variants Affect PSA Levels: Study
- Study Offers New Details About Deadly Staph Bacteria
- Cuts in HIV/AIDS Drug Program Cause Alarm
- Congress Approves National Plan to Fight Alzheimer's Disease
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Avastin Shouldn't Be Used to Treat Breast Cancer: FDA
The drug Avastin (bevacizumab) should no longer be used to treat breast cancer because recent studies have failed to support initial findings that the drug helps slow the disease, the U.S. Food and Drug Administration said Thursday.
"After careful review of the clinical data, we are recommending that the breast cancer indication for Avastin be removed," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an agency news release. She added that "the limited effects of Avastin combined with the significant risks led us to this difficult decision."
While the agency's decision has the support of many cancer experts, it is likely to be criticized by patients and some doctors who believe Avastin benefits breast cancer patients, the Associated Press reported.
The FDA's 2008 approval of Avastin for breast cancer was based on studies that suggested the drug stopped the spread of breast cancer for more than five months. However, four follow-up studies found that the delay lasted no more than three months.
In addition, many patients experienced dangerous side effects, including high blood pressure, bleeding and hemorrhage, heart attack or heart failure, and holes in the body, including in the nose, stomach and intestines, according to an FDA news release.
FDA noted that Genentech, which makes Avastin, "has not agreed to remove the breast cancer indication voluntarily." The company has 15 days to request a hearing on the FDA decision.
"Off-label" use of Avastin for breast cancer will still be permitted but some insurers may not pay for such treatments, the AP reported.
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No Need to Fear Synthetic Biology: Bioethics Commission
Synthetic biology poses few risks because it is still in its early stages and there is no need to impose new restrictions on, or temporarily halt, this type of research, says a report being released Thursday by the Presidential Commission for the Study of Bioethical Issues.
President Obama ordered the examination of synthetic biology -- which uses the synthesis and manipulation of DNA to create new organisms -- after American scientist J. Craig Venter and colleagues said they created what might be considered the first synthetic organism, The New York Times reported.
Venter's team used chemicals to make the complete genome of a bacterium and transplanted it into a similar type of bacterium, where the new genome took charge of the organism.
The achievement alarmed some critics, but the bioethics commission said Venter and colleague did not create life. Instead they duplicated a known genome and placed it in an already living cell, The Times reported.
The commission also said there is no immediate likelihood that synthetic biology can create any truly new organisms.
"Here's something significant in science, but there's no cause for fear and dread about what is going to happen immediately next," Amy Gutmann, commission chairwoman and president of the University of Pennsylvania, told The Times.
The commission made 18 recommendations, including self-regulation by synthetic biologists, better coordination of government agencies that oversee various aspects of the field, and ethics training for synthetic biologists.
"The commission thinks it imprudent either to declare a moratorium on synthetic biology until all risks can be determined and mitigated, or to simply 'let science rip,' regardless of possible risks," the report said. "The commission instead proposes a middle ground an ongoing system of prudent vigilance that carefully monitors, identifies and mitigates potential and realized harms over time."
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