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Improving Recovery Of Soldiers With Severe Injuries
When a soldier is wounded during combat, surgeons must focus on reducing infection and reconstructing damaged bone and tissues. Technologies that could improve the repair and regeneration processes are being developed in research laboratories across the country, but they are not being moved quickly enough into military trauma centers.
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'Real Debate' In Sotomayor's Confirmation Hearing Will Be About Power Of Legislators, Judiciary, Opinion Piece Says
"There is something profound, but also something superficial, about the debate that occurs every time a Supreme Court justice is nominated," Kevin Baine, a First Amendment lawyer and former clerk to Supreme Court Justice Clarence Thomas, writes in a Washington Post opinion piece in reaction to President Obama"s nomination of Judge Sonia Sotomayor to the Supreme Court. According to Baine, the "debate is profound because it probes the delicate role of an independent judiciary in a democracy," but it is "superficial when it turns into an argument over whether judges should be making law or simply interpreting it." He continues, "For a nominee, the safe answer is that the Supreme Court should interpret law." However, it would be "refreshing" if a nominee "acknowledged that courts, including the Supreme Court, make law all the time," he adds. As evidence of this, Baine writes that "basic rules and policies that govern our relations with each other were developed entirely by judges," including principles "that are not remotely controversial," such as obligations to honor contracts and being held liable for damages resulting from negligence. According to Baine, the "controversy arises principally when the court strikes down a law enacted by Congress or a state legislature," such as when the Supreme Court overturned state laws prohibiting abortion in Roe v. Wade. What makes Roe and other decisions striking down state laws controversial is "not that the court was making law but that it was remaking law enacted by elected representatives," he writes.Baine asks, "So how should a Supreme Court justice go about resolving the constitutional issues that divide the court?" He writes that senators in Sotomayor"s confirmation hearing likely will focus on specific issues, such as whether she agrees with a constitutional right to abortion. "The real debate, however, will be over who gets to decide the most controversial issues of the day -- elected representatives who are responsive to majority will or an independent judiciary that is (relatively) immune from public pressure," according to Baine. Although legislation "can be revoked at any time for any reason," a "constitutional decision by the Supreme Court ... is for all time," he adds (Baine, Washington Post, 6/9).
News of the day
Big Disparities In The Treatment Of Arrhythmias Across Europe
The latest statistics regarding the use of pacemakers and implantable cardiac devices in Europe was presented on Sunday 21 June, at EUROPACE 2009, the meeting of the European Heart Rhythm Association (EHRA)1 which takes place in Berlin, Germany from 21 to 24 June.
Oncology

AFRESA(R) Phase 3 Pulmonary Function Safety Data In Patients With Diabetes Presented At ADA

AFRESA® (insulin human [rDNA origin]) Inhalation Powder is a well-tolerated, ultra rapid acting insulin with changes in pulmonary function tests comparable to usual antidiabetic treatment, according to data presented today at the American Diabetes Association"s 69th Scientific Sessions. Results from the prospective, multicenter, phase 3 study conducted over a two-year period showed no difference in mean change in forced expiratory volume in one second (FEV1) between those treated with AFRESA and those treated with standard insulin therapy. "Current mealtime insulin therapies, while accepted as an effective means to control glucose levels, have several limitations," said Peter Richardson, Corporate Vice President and Chief Scientific Officer, MannKind Corporation. "Our encouraging findings indicate that AFRESA may be a promising new treatment option with less weight gain and lower risk of hypoglycemia compared with current mealtime insulin therapy." AFRESA is a novel, ultra rapid acting mealtime insulin therapy with an action profile that mimics meal-related early insulin release. Based on an extensive phase 3 clinical program, a New Drug Application (NDA) has been accepted by the U.S. Food and Drug Administration (FDA) requesting approval to market AFRESA Inhalation Powder and the AFRESA Inhaler for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. AFRESA is conveniently administered by oral inhalation. Diabetes, which affects 23.6 million people in the U.S., or 8 percent of the population, is characterized by the body"s inability to properly regulate levels of blood glucose, or blood sugar. Insulin, a hormone produced by the pancreas, normally regulates the body"s glucose levels, but in people with diabetes insufficient levels of insulin are produced (type 1 diabetes) or the body fails to respond adequately to the insulin it produces (type 2 diabetes). Current mealtime insulin therapy regimens have a number of limitations, including the risk of severe hypoglycemia, the likelihood of weight gain, inadequate post-meal glucose control, the need for complex titration of insulin doses in connection with meals and the need for injections. Additionally, current therapies do not mimic the natural time-action profile of insulin normally seen in healthy individuals and present challenges in maintaining compliance. Study Design and Key Findings Findings were based on pulmonary function tests (PFTs) over a 2-year period in subjects with type 1 and 2 diabetes mellitus receiving AFRESA (n=730) or usual antidiabetic treatment (n=824), along with nondiabetic subjects (n=145). The main study end-point was change from baseline in pre-bronchodilator FEV1 at 2 years (non inferiority margin of 50 ml/year). Secondary endpoints included change from baseline in other PFT parameters (forced vital capacity, total lung capacity, and carbon monoxide diffusion test). Consistent with the normal course of aging, PFTs declined in all groups, including the nondiabetic group. Based on the predefined endpoint, over 2 years, there was no difference in mean change in FEV1 (mean change = 0.037 ÷± 0.012) from baseline to 24 months between AFRESA and usual care, consisting of insulin or oral therapies. About AFRESA® AFRESA® is a novel, ultra rapid acting mealtime insulin therapy being studied for use in adult patients with type 1 and type 2 diabetes mellitus for the treatment of hyperglycemia. It is a drug-device combination product, consisting of AFRESA Inhalation Powder pre-metered into single use dose cartridges and the light, discreet and easy to use AFRESA Inhaler. Administered at the start of a meal, AFRESA dissolves immediately upon inhalation and delivers insulin quickly to the blood stream. Peak insulin levels are achieved within 12 to 14 minutes of administration, effectively mimicking the release of meal-time insulin observed in healthy individuals. The AFRESA phase 2/3 clinical program included over 4,500 adult patients. MannKind Corporation


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