Bimatoprost for Chemo Effects?
The National Cancer Institute and the pharmaceutical maker Allergan Inc. are jointly supporting a trial to determine whether bimatoprost (Latisse) can stimulate regrowth of eyelashes and eyebrows after their loss in chemotherapy. The company told a Food and Drug Administration advisory committee in December 2008 that it would explore that potential use of the drug. The study began enrolling patients in October and will be led by Dr. Jenny Kim of the Jonsson Comprehensive Cancer Center at University of California, Los Angeles. Men and women who have been diagnosed with breast cancer will be enrolled at nine sites and followed for 6 months.
FDA Releases Tanning Warning
The FDA has created a Web site that details for consumers what the agency calls the risks of indoor tanning, skin cancer being among the biggest. “It's well established that UV radiation from the sun causes skin cancer,” FDA scientist Sharon Miller writes on the site. “Since lamps used in tanning beds emit UV radiation, the use of indoor tanning devices also increases your risk of skin cancer.” The agency Web site also lists premature aging, immune suppression, eye damage, and allergic reactions as indoor-tanning downsides. Children and teens are particularly at risk, according to the FDA. The site includes the story of a former Miss Maryland who was diagnosed with melanoma at age 20, after 3 years of heavy indoor tanning.
Adverse Event Reports Go Unused
The FDA's Center for Devices and Radiological Health fails to use adverse event reports in a systematic manner to detect and address medical device safety problems, a report from the HHS Office of Inspector General found. Manufacturers and medical facilities are required to promptly submit reports to the FDA center following adverse events, which can include deaths, serious injuries, and device malfunctions. But the center has no documentation of following up on these events, and it fails to read most reports in a timely fashion, according to the report. Meanwhile, reports of problems with medical devices are increasing, the Inspector General's office found: The FDA center received about 73,000 adverse event reports in 2003 but more than 150,000 in 2007. The Inspector General recommended that the center develop better protocols for reviewing and tracking the reports.
Drug Pipeline Is Full
Pharmaceutical and biotechnology companies have nearly 1,000 medications and vaccines in the pipeline to treat diseases that disproportionately affect women, according to a report released by the Pharmaceutical Research and Manufacturers of America. The 969 medicines are in clinical trials or under review by the FDA. They include 155 medications for diabetes and 114 for autoimmune diseases, which affect women at a rate three times that for men. Other treatments in the pipeline include 112 for breast cancer, 86 for ob.gyn. conditions, 76 for asthma, 131 for arthritis, and 80 for Alzheimer's disease, according to PhRMA.
Biosimilars May Change Market
The manufacturers of tumor necrosis factor–alpha inhibitors could lose billions of dollars in revenue with the introduction of biosimilars in the United States and Europe, according to the research firm Decision Resources. By 2018, biosimilars of TNF-alpha drugs could cut $9.6 billion from brand sales in the United States, France, Germany, Italy, Spain, and the United Kingdom. But the development could also be a boon for payers in those countries, which could save $4 billion during that period. Decision Resources said it expects the movement to TNF-alpha biosimilars to be driven largely by payers, not physicians. “For the second year in a row, surveyed U.S. payers rank TNF-alpha inhibitors as their top priority” for reducing biologics spending, MaryEllen Klusacek, Ph.D., an analyst at the research firm, said in a statement. “Based on this finding, we anticipate that payer pressure on physicians to prescribe biosimilar TNF-alpha inhibitors will be high.”
Electronic Tools Effective: AHRQ
Consumer health informatics (electronic tools and applications designed to provide tailored health advice to patients) could save money by eliminating the need for some health education activities now performed by clinicians, according to a report from the Agency for Healthcare Research and Quality. Health informatics also could improve clinician-patient interactions that deal with a wide variety of diseases and health issues, the AHRQ noted. The agency reviewed more than 100 studies of consumers getting health information via the Web, computer programs, and other electronic avenues such as texting and chat groups. The analysis found that the most effective health informatics applications tailor messages using a patients' own health information and provide feedback about the person's progress as the intervention unfolds. The AHRQ report also found that feedback provided by a clinician doesn't seem to be any more effective than that provided by computer.