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Lawsuit Filed Over Gene Patent
A group of cancer patients, genetic researchers and professional pathologist organizations has filed a lawsuit against Myriad Genetics and the U.S. Patent Office over the patent of two genes associated with an increased risk of breast and ovarian cancers, the New York Times reports. According to the Times, the government more than 10 years ago granted Myriad the patent on the BRCA1 and BRCA2 genes, as well as the company"s genetic test that measures a patient"s risk for the cancers.The lawsuit was filed by the American Civil Liberties Union and is believed to be the first of its kind, the Times reports. The lawsuit challenges the decision to grant patents on genes to Myriad and companies like it. The plaintiffs say that patents on genes restrict medical and research efforts, while companies like Myriad have said that the patent system supports innovation by giving them a temporary monopoly after they make a discovery, thereby rewarding prior investment in research and development.Wendy Chung, the director of clinical genetics at Columbia University and a plaintiff in the case, said, "With a sole provider, there"s mediocrity." The plaintiffs say that BRCA testing would improve with market competition. Furthermore, some plaintiffs argue that certain natural materials cannot be patented. Jan Nowak, president of the Association for Molecular Pathology and a plaintiff in the case, said, "You can"t patent my DNA, any more than you can patent my right arm, or patent my blood."To date, two government panels, including the National Research Council, found no evidence that gene patents result in significant impediments to research or medical care (Schwartz, New York Times, 5/13).

THT Launches New Campaign Encouraging Gay Men To 'THIVK - Test - Take Control
In a bid to reduce dangerous levels of undiagnosed HIV among gay men, Terrence Higgins Trust (THT) is launching a new campaign encouraging men to take control of their sexual health by regularly testing for HIV. The campaign "THIVK - Test - Take Control" will be run through a stand-alone website (http://www.thinkHIV.co.uk), adverts in gay press, posters, leaflets and condom packs, carrying the following messages:
News of the day
Dems' Health Care Reform Plans Would Include Abortion Coverage, Washington Times Opinion Piece States
As lawmakers work to pass health reform legislation, "few are talking about" the "essential question" of whether "health reform will force taxpayers to pay for abortions for the first time in 30 years," Family Research Council President Tony Perkins writes in a Washington Times opinion piece. According to Perkins, "the short answer is yes" because there is no "explicit provision" in any Democratic health plan that would "[p]revent taxpayer funding of abortions as part of the health care benefit Congress is considering"; avert "delays in health care services that result in the death of the patient waiting for care"; or allow health care providers "to refuse to participate in health care-related action that violates their conscience." Perkins continues that the House"s reform proposal would provide federal coverage for ""family planning," the well-worn buzz word that includes abortion unless specified to the contrary." He adds that "it would be naive to assume, unless there is an explicit prohibition in the bill, that [HHS] Secretary Kathleen Sebelius will not use her discretion to fund abortions with taxpayers" money." Perkins also writes that the Democratic reform plans, "in short, ... attempt to be silent on the key question of whether or not to allow the U.S. government to fund abortions with taxpayers" money," and also give the HHS secretary "the power to allow taxpayer-funded abortions."He writes, "The Family Research Council"s answer is clear: There must be a permanent prohibition on taxpayer-funded abortions," as well as "provision to allow a right of conscience for doctors and nurses and other health care providers" to refuse to participate in treatments they oppose. He adds that "there can be no system of denial or delay or rationing of care." Perkins concludes, "Euthanasia by any other name is a poison pill in the health reform debate" (Perkins, Washington Times, 7/5)
Nutrition

Wyeth Presents New Analyses Of Data From Three Studies Of ENBREL(R) At The European League Against Rheumatism (EULAR) Annual Meeting

Analyses of data from three studies provide insight into the use of ENBREL®(etanercept) in the treatment of three conditions for which ENBREL is indicated: moderate-to-severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). These analyses, presented this week during the European League Against Rheumatism (EULAR) Annual Meeting in Copenhagen, add to the body of evidence that supports treatment with ENBREL for patients with these conditions. Analyses from three separate trials of ENBREL -- COMET*, ASCEND** and PRESTA*** -- showed that: The group of patients with early-active moderate-to-severe RA treated with ENBREL and methotrexate, who achieved and sustained a halt of progressive joint damage, maintained this level at two years, according to the COMETstudy In patients with AS (including those with and without peripheral joint involvement), ENBREL therapy significantly improved signs, symptoms, function, and mobility when compared to treatment with the DMARD sulfasalazine, according to the ASCEND study At step-down and usual doses, ENBREL provided significant improvement in joint symptoms compared to baseline in patients with active PsA in addition to achieving clearer skin, according to the PRESTA study "Inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis significantly impact the daily lives of the patients who live with these conditions. These analyses support the role of etanercept therapy in the management of these diseases. The EULAR congress provides an important platform to present new information regarding ENBREL as a treatment option for patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis," said Maxime Dougados, Professor of Rheumatology, RenÓ© Descartes University Paris, France. *The COMET Study The COMET (COmbination of Methotrexate and ETanercept in early rheumatoid arthritis) study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy (EM) with methotrexate alone (M) on clinical disease activity and progressive joint damage in patients with early active rheumatoid arthritis. COMET was the first published study to use clinical remission as a primary endpoint. Subjects were randomised at baseline. Those who completed 1 year of treatment entered year 2 (n=411). The original combination group either continued combination (EM/EM; n=111) or received ENBREL monotherapy (EM/E; n=111) in year 2; the original methotrexate monotherapy group either received combination (M/EM; n=90) or continued monotherapy (M/M; n=99). Efficacy endpoints included clinical remission (DAS28**The ASCEND Study Ankylosing spondylitis (AS) is a debilitating condition that affects three times as many men as women. It typically causes inflammation and pain in the spine (known as axial disease), but can also affect the peripheral joints. As a result of this pain, patients with AS are three times more likely to stop working than the general population. The ASCEND study compared the efficacy of ENBREL with the DMARD sulfasalazine in subjects with AS, including those with peripheral joint involvement. It was the first published study to use an active comparator. A post-hoc analysis compared the efficacy of ENBREL 50 mg once weekly with sulfasalazine up to 3 g daily in subjects with and without swollen peripheral joint involvement from a 10-week randomized, double-blind study in subjects with AS. Regardless of swollen peripheral joint involvement, subjects receiving ENBREL showed significantly greater improvement than subjects receiving sulfasalazine in all efficacy assessments, including physical function and spinal mobility. In particular, 76 percent of patients taking ENBREL versus 53 percent of patients taking sulfasalazine, achieved an ASAS 20 (p***The PRESTA Study Psoriatic arthritis (PsA) is a disabling form of arthritis that occurs in up to 30 per cent of patients with plaque psoriasis. The PRESTA study was designed to determine the efficacy of two ENBREL dosing regimens in treating PsA, as measured by PsA response criteria (PsARC), arthritic symptoms, skin manifestations and physical function of subjects with psoriasis and PsA over 24 weeks. In this study, a randomised double-blind phase was followed by an open-label period. Patients received either ENBREL 50 mg once weekly (QW) or 50 mg twice weekly (BIW) for 12 weeks (double blind), followed by 50 mg QW for all patients for 12 weeks (open label). Data from the trial showed that at usual doses as well as at step-down doses (i.e., 50 mg once a week or 50 mg twice a week for first 12 weeks, then 50 mg once a week), ENBREL provided significant improvement compared to baseline in joint symptoms in patients with active psoriatic arthritis in addition to achieving clearer skin. Furthermore, the new data showed that ENBREL significantly relieved two painful and difficult-to-treat features of psoriatic arthritis, in which inflammation occurs in the fingers (dactylitis) and/or at any point where a tendon or ligament is inserted into bone, particularly the heel of the foot (enthesitis). Efficacy results presented at EULAR showed - for joints: For physician global assessment of arthritis, HAQ and subject global assessment of joint pain, arthritis activity and stiffness, within-group improvements from baseline for the 2 regimens were significant (p 1 tendon or ligament insertion at weeks 12 and 24: 74 percent for ENBREL 50 mg BIW/QW versus 70 percent 50mg QW/QW at week 12 and 81 percent for both groups at week 24. These improvements were accompanied by improved quality of life Efficacy results presented at EULAR showed - for skin: At week 24, PASI 75 improvement was achieved by 70 percent in the BIW/QW group and 62 percent in the QW/QW group Similarly at week 24, the percentage of psoriasis responders, clear or almost clear on the physician global assessment, was 56 percent for the ENBREL 50 mg BIW group and 50 percent for the 50 mg QW group. Wyeth


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