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Sotomayor Signals Support For Roe V. Wade In Meetings With Senators
Supreme Court nominee Sonia Sotomayor in conversations with senators has indicated her support for Roe v. Wade, even if she has not explicitly stated that she supports abortion rights, the AP/Yahoo! News reports. According to the AP/Yahoo! News, Sotomayor is "following a time-honored tradition" among nominees of assuring senators that she will not aim to impose a certain agenda, while also avoiding firm commitments on how she might rule on certain issues -- such as abortion rights -- if they come before the court. In questioning Sotomayor, senators hope to obtain assurances that she will honor certain precedents, such as Roe, which allows them to justify their votes for her to their constituents, the AP/Yahoo! News reports. Doug Kendall of the Constitutional Accountability Center said, "There"s always a bit of a parlor game that develops in terms of what precisely words said by nominees mean."Because Sotomayor has never directly ruled on the key issues in Roe, advocates on both sides of the abortion-rights debate have speculated over her views on constitutional privacy rights. White House spokesperson Robert Gibbs has said that President Obama and Sotomayor discussed her "views on unenumerated rights in the Constitution and the theory of settled law." The AP/Yahoo! News reports that Gibbs" comments indicate that Sotomayor would be unlikely to overturn Roe, which supporters consider "settled law." Sens. Dianne Feinstein (D-Calif.) and Benjamin Cardin (D-Md.), both of whom support abortion rights, said they spoke with Sotomayor about her position during private meetings and were pleased with her answers. Feinstein said that Sotomayor is "a woman who is well-steeped in the law and well-steeped in precedent, and I believe that she has a real respect for precedent." Sen. Jim DeMint (R-S.C.), an opponent of abortion rights, said that when he privately asked Sotomayor whether she believed a fetus should have any constitutional rights, she responded that she had never considered the issue (Hirschfeld Davis, AP/Yahoo! News, 6/18).

Some Routine Cancer Screenings Not Proven To Reduce Deaths, Experts Say
Routine screenings for cancers -- including breast cancer in younger women -- have not proven to reduce the chance of death for people without specific symptoms or risk factors, and experts suggest that some tests could lead to harm, the New York Times reports.According to Ned Calonge, chair of the United States Preventive Services Task Force, screening is only useful if it prevents enough deaths to outweigh harm from treatments that are not medically necessary. He said that although screening in some cases will detect life-threatening cancers that respond to intervention, it also can result in false positives that cause needless worry and unnecessary procedures. Screening also might fail to diagnose an existing cancer, causing patients to ignore symptoms; find slow-growing or stable cancers that are not life-threatening and normally do not need treatment; or find aggressive, life-threatening cancers that do not respond to treatment, Calonge said. Only a handful of screening tests have been proven to significantly reduce death among certain age groups: pap tests to screen for cervical cancer beginning no later than age 21; mammograms to screen for breast cancer starting at age 40; and colon cancer screening beginning at age 50. According to the Centers for Disease Control and Prevention, there is no medical proof that routine screening for many other cancers -- including ovarian cancer -- reduces deaths.The Times reports that the Breast Cancer Education and Awareness Requires Learning Young Act of 2009 (HR 1740) -- also known as the Early Act -- has become a central issue in the debate because it would create a breast cancer detection campaign for women younger than age 45. Rep. Debbie Wasserman-Schultz (D-Fla.) introduced the bill in March, and it now has more than 350 co-sponsors. The bill would provide $45 million over five years for teaching young women and their physicians to check for abnormalities; promote healthy lifestyle choices; and provide grants to groups supporting women with breast cancer. The bill focuses on certain ethnic or racial groups at higher risk of developing aggressive tumors. CDC would oversee an expert panel to create the campaign based on the latest medical research, Wasserman-Schultz said.Critics of the bill say that the legislation promotes techniques, such as self-exams, that have not proven to detect cancer at earlier stages or reduce deaths. They also argue that self-exams could lead to many insignificant nodules being biopsied, which can cause scarring and make it harder to detect breast cancer when women are older. According to Susan Love -- a breast cancer surgeon who has encouraged Wasserman-Schultz to abandon the bill -- the public health campaign could cause younger women to overestimate their chances of dying of breast cancer (Singer, New York Times, 7/17).
News of the day
Medicare Expenditures Decrease For Glaucoma Surgery As Number Of Procedures Increases
The overall number of glaucoma surgical procedures appears to be increasing, but payments by Medicare for the procedures have been decreasing, according to a report in the July issue of Archives of Ophthalmology, one of the JAMA/Archives journals.
Cardiovascular

Allergan Receives FDA Approval For ACUVAIL(TM) Ophthalmic Solution For The Treatment Of Pain And Inflammation Following Cataract Surgery

Allergan, Inc. (NYSE: AGN) announced that the United States Food and Drug Administration (FDA) has approved ACUVAIL(TM) (ketorolac tromethamine ophthalmic solution) 0.45%, an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery. Cataracts are a leading cause of blindness among older adults and cataract surgery is the most frequently performed surgical procedure in the United States, with more than 3 million procedures performed each year.1 ACUVAIL(TM) is formulated at pH 6.8, enabling deionized drug delivery on the corneal surface. ACUVAIL(TM) contains carboxymethylcellulose (CMC), a viscous molecule also found in Allergan"s REFRESH(R) Brand Tears that enables the drug to adhere to the ocular surface and enhances patient comfort. With ACUVAIL(TM), patients benefit from the drug"s comprehensive inhibition of the COX-1 and COX-2 enzymes. Studies show that those enzymes should be blocked in order to inhibit the development of prostaglandins, which are considered to be the primary s of pain and inflammation following cataract surgery. "Building on Allergan"s 60-year expertise in eye care, we are pleased to provide physicians and their patients with an advanced and effective NSAID option for the treatment of pain and inflammation following cataract surgery," said Scott Whitcup, M.D., Allergan"s Executive Vice President, Research and Development and Chief Scientific Officer. "With its preservative-free formulation, optimized tolerability and twice-daily dosing convenience, we anticipate that ACUVAIL(TM) will be a valuable addition to the overall management of cataract surgery patients." The efficacy of ACUVAIL(TM) ophthalmic solution was assessed in two multi-center, randomized, double-masked, parallel group comparison studies involving more than 500 patients receiving either ACUVAIL(TM) or vehicle. In the clinical studies, the efficacy of ACUVAIL(TM) was defined as complete clearance of anterior chamber inflammation measured by summed inflammation score (SOIS) and ocular pain relief following cataract extraction with posterior chamber intraocular lens (IOL) implantation. Results of these studies demonstrated that at day seven, nearly twice as many patients receiving ACUVAIL(TM) solution had an SOIS score of zero when compared to patients treated with vehicle (32 percent versus 17 percent). In addition, patients were shown to have a significantly higher incidence of clearing of anterior chamber inflammation at day 14 versus patients receiving vehicle (53 percent versus 26 percent). ACUVAIL(TM) was also shown to be significantly superior to vehicle in resolving ocular pain post-cataract surgery. On day one post-cataract surgery, the percentage of ACUVAIL(TM) patients with pain scores of zero was 72 percent, compared to 40 percent for patients in the vehicle group. "As an ophthalmic surgeon, I rely on effective therapies that provide my patients with an optimal experience and improve visual outcomes," said Eric Donnenfeld, M.D., F.A.C.S., Ophthalmic Consultants of Long Island. "ACUVAIL(TM) is an enhanced ketorolac compound and the first preservative-free, twice-daily ophthalmic NSAID that demonstrates complete elimination of inflammation for patients undergoing cataract surgery." ACUVAIL(TM) is expected to be available to physicians and patients in the United States in September 2009. About Cataracts Cataracts are a leading cause of blindness among older adults in the United States. The exact cause of cataracts is unknown. Most often, cataracts are part of the aging process. As people age, they are at greater risk of developing a cataract. More than 20 million Americans age 40 and older have cataracts and more than half of all Americans have cataracts by the time they are 80 years old. A cataract is a clouding of the eye"s lens, which blocks or changes the passage of light into the eye. The lens of the eye is located behind the pupil and the colored iris, and is normally transparent. The lens helps to focus images onto the retina - which transmits the images to the brain. A person"s vision may become blurry or dim because the cataract stops light from properly passing through to the retina. Risk factors for cataracts include intense heat or long-term exposure to UV rays from the sun; certain diseases, such as diabetes; inflammation in the eye; hereditary influences; events before birth, such as German measles in the mother; long-term steroid use; eye injuries; eye diseases; and smoking. Although stronger eyeglasses or brighter lighting may help relieve symptoms of a cataract in the early stages, surgery is the only cure and the most common form of treatment. Cataract surgery is the most frequently performed surgical procedure in the United States, with more than 3 million procedures performed each year. Typically covered by medical insurance, including Medicare, the surgery is usually done as an outpatient procedure under local anesthesia. The procedure consists of an ophthalmologist making a tiny incision to remove the cloudy lens and replacing it with a permanent artificial lens. INDICATIONS AND USAGE ACUVAIL(TM) ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery. DOSAGE AND ADMINISTRATION One drop of ACUVAIL(TM) should be applied to the affected eye twice-daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of the postoperative period. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS ACUVAIL(TM) solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. WARNINGS AND PRECAUTIONS Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs. With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ACUVAIL(TM) ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. ADVERSE REACTIONS The most common adverse events were reported in 1-6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred. Some of these events may be the consequence of the cataract surgical procedure. About Allergan, Inc. Founded in 1950, Allergan, Inc., with headquarters in Irvine, California, is a multi-specialty health care company that discovers, develops and commercializes innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential - to see more clearly, move more freely, express themselves more fully. The Company employs more than 8,000 people worldwide and operates state-of-the-art R&D facilities and world-class manufacturing plants. In addition to its discovery-to-development research organization, Allergan has global marketing and sales capabilities with a presence in more than 100 countries. Forward-Looking Statements This press release contains "forward-looking statements," including the statements by Dr. Whitcup and Dr. Donnenfeld, statements regarding research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding ACUVAIL(TM). These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan"s expectations and projections. Risks and uncertainties include, among other things, general industry and pharmaceutical market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new pharmaceutical products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan"s public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan"s 2008 Form 10-K and Allergan"s Form 10-Q for the quarter ended March 31, 2009. © 2009 Allergan, Inc. Irvine, CA 92612. (R) and (TM) marks owned by Allergan, Inc. 1 Allergan Data on File Allergan, Inc


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