Monday, November 20, 2006

FDA Approves Silicone Breast Implant for Breast Reconstruction, Cosmetic Augmentation; Limits Cosmetic Use to Women Over Age 21
[Nov 20, 2006]

      FDA on Friday approved the use of silicone breast implants manufactured by Santa Barbara, Calif.-based Mentor and Irvine, Calif.-based Allergan for breast reconstruction and cosmetic breast augmentation, but the agency limited cosmetic use to women ages 22 and older, the New York Times reports (Saul, New York Times, 11/18). Most breast implants, which often are given to women who have undergone a mastectomy to treat breast cancer, contain saline solution. Silicone breast implants were banned in 1992 because of safety concerns. Mentor and Inamed, which now is part of Allergen, applied to sell silicone implants, and FDA in July and September 2005 gave both applications preliminary approval pending the meeting of certain conditions (Kaiser Daily Women's Health Policy Report, 10/24). The approval stipulates that the manufacturers inform women that the implants "are not lifetime devices" and that most recipients will need at least one additional surgery to replace or remove their implants, the Washington Post reports. In addition, FDA is requiring both companies to conduct a study among at least 40,000 implant recipients over the next 10 years to determine the long-term safety and efficacy of the implants and provide the findings to the government (Brown/Lee, Washington Post, 11/18). Women also will need to receive magnetic resonance imaging every two to three years to ensure the implants are not leaking, according to Daniel Schultz, director of FDA's Center for Devices and Radiological Health (Allday, San Francisco Chronicle, 11/18). According to Schultz, the agency's decision that the sale of the implants is in the best interest of women was based on company-sponsored studies, as well as on long-term use of the implants worldwide. Mentor on Friday launched a Web site to advertise their product, called Memory Gel.

Comments
The approval is a "triumph of science," Richard D'Amico, president-elect of the American Society of Plastic Surgeons, said, adding, "We've always felt that the science would bear out the use of the implants" (New York Times, 11/18). Kenneth Phillips, chief of the department of plastic, reconstructive and cosmetic surgery at Kaiser Permanente said, "It's been a long time coming. The FDA has really scrutinized the subject and looked at a lot of research" (San Francisco Chronicle, 11/18). Critics "lambasted" the decision and said that some safety concerns had not been resolved, the Times reports. Amy Allina, program director at the National Women's Health Network, said the agency failed to answer basic safety questions, including how long the implants would last without rupturing and the potential health effects if the silicone leaked to other parts of the body (New York Times, 11/18). Susan Wood -- a research professor at George Washington University's School of Public Health and Health Services and former FDA official for women's health -- said she is disappointed by the approval because the agency did not demonstrate that the implants are safe. "Given that the approval has gone through, we have to insist on getting adequate information for both patients and surgeons so that we ultimately will know whether or not these are products that women should be using," Wood said (Washington Post, 11/18). Allergen President Michael Ball said the implants should be widely available in about two weeks (San Francisco Chronicle, 11/18).

Editorial
"It took 14 years, but science finally trumped politics ... with the [FDA]'s lifting of its longstanding ban on silicone-gel breast implants," a Wall Street Journal editorial says. "While we're glad the FDA has overturned 14 years of politicized medicine, ... it's worth remembering the enormous price that has been paid: to the credibility of the legal system, in jobs lost and in public health," the editorial says, adding that the approval is "especially welcome news for mastectomy patients." According to the editorial, "It would be nice to think that the FDA's move closes the chapter on this nasty episode, but given the anti-implant crowd's reaction to Friday's announcement, that's probably too much to hope for" (Wall Street Journal, 11/20).

NPR's "Weekend Edition Saturday" reported on FDA's approval of the silicone breast implants. The segment includes comments from Schultz; Scott Spear, a plastic surgeon in Washington, D.C.; and a woman who opposes silicone implants after her experiences in the 1980s (Knox, "Weekend Edition Saturday," NPR, 11/18). Audio of the segment is available online. NPR's "All Things Considered" on Friday reported on FDA's approval of silicone breast implants. The segment includes comments from Schultz ("All Things Considered," NPR, 11/17). Audio of the segment is available online.

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8th Circuit Court Panel Hears Arguments in Appeal of Ruling That Union Pacific Railroad Must Cover Contraceptives in Health Plan
[Nov 20, 2006]

     If a three-judge panel of the 8th U.S. Circuit Court of Appeals upholds a federal court ruling that Union Pacific Railroad must cover contraceptives in its health insurance plan, it could mandate all companies to provide contraceptive coverage, 8th Circuit Court Judge Pasco Bowman said on Thursday in St. Louis during arguments in the appeal of the ruling, the AP/Kansas City Star reports (Leonard, AP/Kansas City Star, 11/17). Two female Union Pacific employees, represented by Planned Parenthood of Western Washington, filed a lawsuit that seeks to require the company to provide coverage for FDA-approved prescription contraceptives for female employees and the female family members of male employees covered by the company's health plan. U.S. District Judge Laurie Smith Camp in July 2005 ruled that Union Pacific, which employs about 49,000 workers nationwide, including 1,300 women, illegally discriminated against female employees by not providing contraceptive coverage in its health plans. Although Smith Camp did not order the company to begin covering contraceptives, she said Union Pacific's policy violated the federal Civil Rights Act of 1964, which prohibits employers with 15 or more employees from discrimination based on gender or pregnancy. Smith Camp ruled that the health plan policy was discriminatory because it covered many preventive health medications -- including drugs for erectile dysfunction -- but not contraception. The company has argued that it did not need to provide contraceptive coverage "because fertility is 'normal,'" and, therefore, birth control is not "medically necessary" (Kaiser Daily Women's Health Policy Report, 7/27/05).

Arguments
Donald Munro, an attorney representing Union Pacific, on Thursday told the 8th Circuit Court panel that the company's policy is not discriminatory because both men and women are denied contraceptive coverage under company health plans. Munro added that the health plan provided contraceptive coverage for female employees who would experience higher health risks, such as high blood pressure, if they became pregnant. Roberta Riley, an attorney for the employees, said women contraceptive access is a critical component of women's health. Bowman during the hearing said, "You're talking about a huge decision that would affect a lot of companies besides Union Pacific"(AP/Kansas City Star, 11/16).

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Public Health & Education

 

FDA Expands Approval of Herceptin for Breast Cancer Treatment
[Nov 20, 2006]

      FDA expanded approval of Genentech's Herceptin to include the treatment of a type of breast cancer when it has not spread beyond the breast or lymph nodes in patients who have undergone a lumpectomy or mastectomy, the New York Times reports (Grady, New York Times, 11/17). HER2-positive breast cancer is an aggressive form of the disease found in about 25% of breast cancer patients that involves extra copies of the HER2 protein (Tansey, San Francisco Chronicle, 11/17). FDA in 1998 approved Herceptin for treatment of advanced HER2-positive cancer that has spread beyond the breast, although some doctors began using the drug off-label in combination with chemotherapy to treat early-stage patients after a 2005 study found positive results for such treatment (Reuters, 11/16). The study, which was sponsored by the National Cancer Institute, found that patients who received Herceptin in combination with chemotherapy had a three-year recurrence rate that was about half that of patients who received chemotherapy alone and a risk of death that was about one-third less. A one-year supply of Herceptin at wholesale cost is $38,000, the Chronicle reports (San Francisco Chronicle, 11/17).

NPR's "Day to Day" on Thursday reported on FDA's approval of expanded use of Herceptin. The segment includes comments from Edith Perez, professor of medicine and co-director of the multidisciplinary breast clinic at the Mayo Clinic, and a woman who participated in studies of Herceptin (Neighmond, "Day to Day," NPR, 11/16). Audio of the segment is available online.

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Support for Lung Cancer Patients, Research Has Not Increased Despite High Mortality Rate Among Women
[Nov 20, 2006]

      Although lung cancer mortality rates have surpassed breast cancer mortality rates among women, support for lung cancer patients and for treatment research has not increased, the San Francisco Chronicle reports (Allday, San Francisco Chronicle, 11/17). Lung cancer this year is expected to cause the deaths of an estimated 162,000 people in the U.S., 72,000 of whom likely will be women. Rates of lung cancer deaths among women have held steady in recent years, while the rates of lung cancer deaths among men have decreased. However, women on average survive longer after developing lung cancer than men, and the newest drugs to treat the disease, Tarceva and Iressa, have been more effective in women (Kaiser Daily Women's Health Policy Report, 5/31). Support for fighting lung cancer has not increased in part because many patients often are "made to feel that they brought it on themselves," according to the Chronicle. Heather Wakelee, an assistant professor at Stanford University School of Medicine, said, "Women are still much more afraid of breast cancer, and part of that is the stigma. It's relatively underdiscussed and underfunded." The National Cancer Institute in 2005 spent $560 million on breast cancer research and $266 million on lung cancer research, the Chronicle reports. According to the Chronicle, the effect of a potential funding increase for lung cancer research is not known in part because the disease is "especially difficult" to diagnose and treat. Some physicians say it is essential for researchers to develop a diagnostic tool for lung cancer that is as simple and effective as mammograms are in diagnosing breast cancer. About 15% of people diagnosed with lung cancer live five years, while about 50% of those diagnosed with early-stage lung cancer survive for five years and 38% survive for 10 years, according to NCI. The main diagnostic tools for lung cancer are chest X-rays and CT scans, but X-rays often do not catch early-stage tumors and CT scans can be too sensitive and expensive, ranging from $200 to $500 a scan, the Chronicle reports. A panel of physicians organized by the Lung Cancer Alliance and people diagnosed with lung cancer on Friday at the University of California-San Francisco were scheduled to discuss aspects of the disease, new treatments and methods to raise awareness (San Francisco Chronicle, 11/17).

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Opinion

 

Kaiser Daily Women's Health Policy Report Summarizes Editorials on Keroack Appointment as HHS Deputy Secretary
[Nov 20, 2006]

     Two editorials respond to the Bush administration's appointment of ob-gyn Eric Keroack -- medical director for A Woman's Concern, a pregnancy-counseling organization -- as the new HHS deputy assistant secretary for population affairs. Many family planning advocates were angered by the appointment of Keroack, noting that A Women's Concern opposes contraception and supports sexual abstinence until marriage. Keroack will administer $283 million in annual HHS family planning grants and advise HHS Secretary Mike Leavitt on issues including reproductive health and adolescent pregnancy. HHS Assistant Secretary for Health John Agwunobi called Keroack a "highly qualified and a well-respected physician" (Kaiser Daily Women's Health Policy Report, 11/17).

• Boston Globe: Keroack's appointment "exemplifies the concerns of women's health advocates who have long warned that the antiabortion movement will not stop at abortion," a Globe editorial says. "[T]o name an opponent of family planning to oversee the nation's family planning program is perverse even by the standards of a government that doesn't much believe in government," the editorial says, concluding, "To argue that abstinence is the only acceptable route to family planning divides the country, ignores reality and condemns millions of women to poorer lives" (Boston Globe, 11/18).
  
  
• Washington Post: Keroack's involvement with A Woman's Concern "raises doubts about his commitment to the fundamental concept of the federal family planning program," which offers "timely and affordable access to reliable contraception," a Post editorial says. The editorial concludes that although Keroack's appointment is not subject to Senate confirmation, it "should be subject ... to common sense," adding that Bush and Leavitt "should reconsider this ill-advised choice" (Washington Post, 11/19).
  

NPR's "Weekend Edition Saturday" reported on criticism of Keroack's views on family planning issues. The segment includes comments from Mark Conrad, president of A Woman's Concern; Marilyn Keefe, interim president of the National Family Planning and Reproductive Health Association; and Dianne Luby, president and CEO of the Planned Parenthood League of Massachusetts (Smith, "Weekend Edition Saturday," NPR, 11/18). Audio of the segment is available online.

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