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Cellulite Treatment

Government Responds To Archer Inquiry
The Government today responded to the independent inquiry into contaminated blood supplies in the 1970s and 1980s.
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Biogen Idec Receives Fast Track Designation From FDA For PEGylated Interferon Beta-1a For Relapsing Multiple Sclerosis
Biogen Idec (NASDAQ: BIIB) announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.
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Childbirth-Related Injuries Decline, Linked With Use Of Instruments, AHRQ Report Finds
There were nearly 158,000 potentially avoidable childbirth-related injuries to women and their infants in 2006, a significant decline from 2000, according to a report by the Agency for Healthcare Research and Quality, HealthLeaders Media reports. The report used data submitted for 15 million discharges by 1,900 hospitals in 25 states, including the largest states -- California, New York, Florida and Texas. Between 2000 and 2006, the rate of potentially avoidable injuries during vaginal childbirth without the use of instruments, such as forceps, declined by 30%, according to the report. The injury rate declined by 21.3% for vaginal childbirth using instruments and by 16.7% for women undergoing caesarean sections. Report author Roxanne Andrews of AHRQ said that the report did not examine factors that might have contributed to the declining injury rates but added that it is an area for further study.The report found that rates of injury were higher when instruments were used during childbirth. For instance, trauma to the woman during vaginal delivery with the use of instruments occurred 160.5 times per 1,000 discharges, compared with 36.2 times when instruments were not used. The report said that the most common injuries to women were perineum tears, which are avoidable in many cases. Traumatic injury to infants during childbirth -- such as broken collarbones, head injuries and infections -- occurred 1.6 times per 1,000 discharges.The report also highlighted care disparities between women in low-income areas and those in high-income areas. Women giving birth in high-income areas had 44% more injuries during vaginal delivery than their counterparts in low-income areas. Black and Hispanic women experienced fewer injuries than white women, while Asian American and Pacific Islander women experienced the highest rate of injuries. The report found that women covered by Medicaid were less likely to be injured during childbirth -- 127 injuries per 1,000 deliveries -- compared with women with private insurance plans -- 185 injuries per 1,000 deliveries. However, the rate of injury for infants covered under Medicaid was higher -- 1.7 per 1,000 deliveries -- than those under private plans -- 1.5 per 1,000 deliveries.The report encouraged providers to evaluate their practices to better understand why such complications occur. According to the report, "Identifying which types of patient safety problems exist for different sub-groups of patients is an important first step in developing interventions to reduce disparities and achieve high quality of care for all patients" (Clark, HealthLeaders Media, 6/18).
Cardiovascular

Carboxytherapy And Mesotherapy Unproven - Physician Group Urges Consumers To Be Aware Of Non-approved Cosmetic Injections

The Physicians Coalition for Injectable Safety issued a consumer warning about carboxytherapy and mesotherapy injections. These products, touting everything from cellulite treatment to weight loss are not FDA approved, and do not have clinical data that demonstrates results or safety. Carboxytherapy uses carbon dioxide gas injected under the skin to reduce the look of cellulite, treatment of dark under-eye circles, and stretch marks and is also touted for fat sculpting on the face and the body. "Although many websites or providers claim carboxytherapy is safe and FDA approved, it has not been clinically tested or FDA approved for these purposes," says Coalition leader Robert Weiss, MD of Baltimore, MD. "Carboxytherapy for use around the eyes is especially dangerous. It could potentially release gas bubbles into blood vessels causing blindness. In addition, the risks of putting carbon dioxide in your body are currently unknown." Mesotherapy, also known as injection lipolysis, is a mixture of vitamins, drugs and enzymes that are compounded (mixed together) to make the injected substance. "There is no conclusive, authoritative information that exists, such as unbiased, peer-reviewed clinical studies that meets the standards of an accepted medical journal, measuring both the efficacy and safety of mesotherapy," says Coalition leader Mark Jewell, MD, Eugene, Oregon. "We don"t know the safety or efficacy of these compounds and, until there exists credible evidence, consumers are advised not to have these injections." The Coalition urges consumers to be very selective about cosmetic treatments, and the individuals who provide them. "Only accept treatment prescribed by a qualified physician and administered under that physician"s supervision. Whether an injection or treatment is to treat aging conditions, to treat cellulite or a similar body contouring condition, whether it sounds reasonable or too good to be true, you should always be aware of false claims," says Coalition leader Jeffrey Kenkel, MD of Dallas, TX. "Verifying that the drug or device that is recommended for your injection is FDA approved is an important first step. It should be approved specifically for cosmetic use as prescribed or similarly to what is prescribed for you." The Coalition offers consumers extensive, easy to use res including a cosmetic injection planner with all the questions you must ask your provider at www.injectablesafety.org. In addition, an up-to-date listing of the status of investigational and approved cosmetic injection drugs and devices is available on the site, as well as pictures that will help consumers identify a genuine brand. In addition Consumers are urged to ask and consider these simple questions before considering any cosmetic injectable procedure: - Doctor: Is the injectable recommended by a qualified doctor who regularly treats similar conditions, in an appropriately licensed and equipped medical facility? Has the doctor examined the prospective patient before recommending treatment? - Brand: Is the injectable recommended approved by the U.S. FDA,, and by equivalent agencies in the country of origin, for cosmetic indications and is it appropriately labeled and packaged to reflect its authenticity and approval? - Safety: Is the setting a proper medically-equipped office, with safety and sterilization procedures? Has the physician evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications? The Physicians Coalition for Injectable Safety


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