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New Data: Efficacy And Responder Analyses Of Divigel(R) (estradiol Gel) 0.1 Percent For The Treatment Of Menopause
Upsher-Smith Laboratories, Inc. presented the results of a secondary analysis to determine the response rates to three doses of transdermal Divigel(R) (estradiol gel) 0.1 percent at the recent 57th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG) in Chicago. The objectives of this secondary analysis of a phase III efficacy trial were to determine the percent of postmenopausal women who achieved a greater than 50 percent reduction in the frequency of moderate to severe vasomotor symptoms (MSVMS), or hot flashes, and to assess the change from baseline in a quality of life (Kupperman) index score that evaluated various menopausal symptoms. Divigel(R) doses studied included 1.0 mg, 0.5 mg and 0.25 mg of estradiol/day - the lowest effective approved dose of estradiol available for the treatment of MSVMS. The analysis showed a significantly greater percentage of women in all treatment groups versus placebo experienced > / = 50 percent reduction in the frequency of MSVMS at week 12. In the Divigel(R) 1.0 mg estradiol/day dosing group, 90 percent of women reported at least a 50 percent reduction in the frequency of MSVMS. Additionally, at 12 weeks, each of the doses of Divigel(R) significantly reduced the severity of menopausal symptoms identified by a quality of life index score compared to placebo.
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Drug Manufacturer Receives Fast Track Designation From FDA
Pharmaceutical firm Biogen Idec announced that the American drug watchdog the Food and Drug Administration (FDA) has granted Fast Track designation for its multiple sclerosis (MS) drug PEGylated interferon beta-1a (BIIB017).
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Supreme Court Nominee Sotomayor Pledges 'Fidelity To The Law' As Confirmation Hearing Begins
In the first day of her confirmation hearings before the Senate Judiciary Committee, Supreme Court nominee Judge Sonia Sotomayor said on Monday that "fidelity to the law" is central to her judicial philosophy and that the role of a judge is "not to make law" but "to apply the law," the Washington Post reports. Sotomayor said her record as a district and federal appeals judge "reflects my rigorous commitment to interpreting the Constitution according to its terms, interpreting statutes according to their terms and Congress" intent, and hewing faithfully to precedents established by the Supreme Court and by my circuit court." She also said her "personal and professional experiences help me listen and understand, with the law always commanding the result in every case" (Barnes et al., Washington Post, 7/14). The first day of the hearings was dedicated to opening statements from Sotomayor and senators, with the questioning portion scheduled to begin on Tuesday. According to the Wall Street Journal, Sotomayor is expected to be confirmed, as Democrats outnumber Republicans on the committee 12-7 and hold a 60-member majority in the Senate (Bravin/Bendavid, Wall Street Journal, 7/14). The New York Times reports that senators from both parties are likely to use Sotomayor"s confirmation as a way to frame the debate for the next Supreme Court nominee, with Democrats hoping to "build a lopsided victory" to give President Obama more leeway to choose a more liberal nominee. Conservatives, on the other hand, "hoped to draw a line making the president think twice about picking someone" like Sotomayor in the future, the Times reports (Baker/Lewis, New York Times, 7/14).In Monday"s hearing, both parties gave indications of how they plan to proceed for the rest of the confirmation process, the Post reports. Democrats in their statements portrayed Sotomayor as a role model for the country and a judge with a modest approach who would bring balance to the conservative-leaning court (Washington Post, 7/14). Sen. Charles Schumer (D-N.Y.) said Sotomayor "puts rule of law above everything else." He added, "Given her extensive and evenhanded record, I am not sure how any member of this panel can sit here today and seriously suggest that she comes to the bench with a personal agenda" (Stern/Perine, CQ Today, 7/13). Republicans used their statements to cast Sotomayor as a partial judge, saying previous statements and rulings show she is an activist judge (Washington Post, 7/14). In particular, GOP senators on the committee referenced a comment from a 2001 speech in which Sotomayor said that a "wise Latina" would reach better decisions than a white man in some cases (Baker/Lewis, New York Times, 7/14). Sen. Jeff Sessions (Ala.), the ranking Republican on the committee, said, "No senator should vote for an individual ... who believes it is acceptable for a judge to allow their own personal background, gender, prejudices or sympathies to sway their decision." He continued, "Call it empathy, call it prejudice or call it sympathy, but whatever it is, it"s not law" (Wall Street Journal, 7/14). However, Sen. Lindsey Graham (R-S.C.) noted that Republicans lost in last year"s presidential election and told Sotomayor, "Unless you have a complete meltdown, you"re going to get confirmed" (Lewis, New York Times, 7/14).Antiabortion-Rights Protesters Arrested During HearingsFour antiabortion-rights protesters were arrested for shouting comments during the senators" remarks (CQ Today, 7/13). One of the arrested protesters was Norma McCorvey, the plaintiff "Jane Roe" in Roe v. Wade. According to the AP/Google.com, McCorvey began screaming that Sotomayor was "wrong" about abortion during the opening statement of Sen. Al Franken (D-Minn.). McCorvey and the other three arrested protesters were charged with unlawful conduct-disruption of Congress. The protesters also prompted a warning from Senate Judiciary Committee Chair Patrick Leahy (D-Vt.), who said, "We"ll show respect to everybody who is here, we will show respect to everyb
Medical Devices

Simple Measures May Prevent Transmission Of Stomach Ulcer Bacteria

The stomach ulcer bacterium Helicobacter pylori is not transmitted through drinking water as previously thought, but rather through vomit and possibly faeces. This is shown in a thesis at the Sahlgrenska Academy, University of Gothenburg, Sweden. It is therefore possible to prevent the spread of the bacterium in developing countries through some fairly simple measures. "Taking some cheap but powerful measures may prevent the spread of the bacterium. It could be enough to isolate vomiting patients especially from small children for a short period of time, since Helicobacter pylori is not able to survive for long outside the stomach. If isolation is not possible, it may suffice to pay extra attention to good hygiene", says doctoral student Anders Janzon. The research team analysed the drinking water, lake water and wastewater in an area in Dhaka in Bangladesh, where the bacterium Helicobacter pylori is very common. The results show that while the diarrhoea bacterium ETEC is often present in the drinking water, Helicobacter pylori is not. Other studies have shown that new cases of Helicobacter pylori tend to pop up in connection with various diarrhoea illnesses, and this pointed the research team in the right direction. "We analysed vomit and diarrhoea from cholera patients, and found large amounts of active Helicobacter pylori. We therefore conclude that vomit is a very likely of new infections", says Janzon. ABOUT HELICOBACTER PYLORI Helicobacter pylori is one of the most common disease-causing bacteria among humans. Nearly 90% of the populations in developing countries are infected. The bacterium produces an enzyme that turns urea into carbon dioxide and ammonia, which in turn neutralises the gastric acid in the stomach. The infection can cause ulcers on the lining of the stomach and of the duodenum if it is left untreated, and these conditions can be deadly. The bacterium is also the main cause of stomach cancer. University of Gothenburg


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