Tuesday, May 15, 2012
AIDS fight enters new phase with prevention pill
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FDA panel recommends Gilead's Quad for HIV
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FDA reviews first rapid, take-home test for HIV
FDA reviewers said Friday the OraQuick In-Home HIV test could play a significant role in slowing the spread of HIV, according to briefing documents posted online. But they also raised concerns about the accuracy of the test, a mouth swab that returns results in about 20 minutes.
The review comes one day after an FDA advisory panel endorsed the HIV pill Truvada for preventive use. If FDA follows the group's advice, the daily medication would become the first drug approved to prevent healthy people from becoming infected with the virus that causes AIDS.
Public health experts estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.
In a trial conducted by the company OraSure Technologies Inc., the test correctly detected HIV in those carrying the virus 93 percent of the time. That rate is below the FDA-recommended 95 percent threshold for accuracy.
The FDA estimates the test would miss about 3,800 HIV-positive people per year, if approved for U.S. consumers.
The test was more accurate at correctly clearing patients who do not have the disease. In company studies, OraQuick correctly identified HIV-negative users 99 percent of the time.
In their briefing documents, FDA scientists noted both the benefits and risks of expanding HIV testing with the take-home diagnostic kit.
"There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status," the reviewers state. "However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected."
The lukewarm endorsement apparently spooked investors. OraSure's stock tumbled $1.32, or 11.8 percent, to close at $9.85 in trading Friday.
On Tuesday, the FDA will ask a panel of outside experts whether the test should be approved for over-the-counter sales in U.S. The agency is not required to follow the group's advice, though it usually does.
Based in Bethlehem, Pa., OraSure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. The test sells for $17.50, though OraSure declined to discuss how it would price the consumer version. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.
While it's not clear why the test was less accurate in consumer trials, CEO Doug Michels said company researchers anticipated that its "performance in the hands of a consumer would be different from that observed in hands of a professional."
OraSure tried the new version of the test in a study of 5,800 people of various sexual orientation, race and income levels. The trial identified about 100 HIV carriers who were previously undiagnosed.
The FDA has already approved HIV test kits that people take home. However, those kits, which require a blood sample, must be sent to a laboratory for development. But OraSure argues that a test that can be done at home will appeal to a much broader group of people.
According to the company's study, 41 percent of people who discovered they were HIV-positive using OraQuick had never been tested previously. In its own briefing documents, the company estimates that 9,000 new HIV carriers would be identified for every 1 million people who use the test.
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Tennessee governor signs controversial "gateway sexual activity" bill
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Monday, May 14, 2012
Lifesaving Defibrillators Often Not Nearby When Needed
Cardiac arrest occurs when an abnormal heart rhythm causes the heart to stop beating. Automated external defibrillators are devices that use electrical shocks to restore the heart to a normal rhythm.
The findings may help explain why cardiac arrest survival rates remain below 10 percent in most areas of the United States, despite AED and cardiopulmonary resuscitation (CPR) awareness programs, according to the researchers at the University of Pennsylvania School of Medicine.
For the study, the research team examined the locations of nearly 3,500 out-of-hospital cardiac arrests and the locations of more than 2,300 automated external defibrillators throughout Philadelphia County. The devices were most commonly located in schools and on university campuses (30 percent), in office buildings (22 percent) and in residential buildings (4 percent).
The investigators found that just 7 percent of cardiac arrests occurred within a 200-foot radius of an automated external defibrillator, which is about a two-minute round-trip walk from the scene of the emergency. Ten percent of cardiac arrests occurred within 400 feet and 21 percent occurred within 600 feet -- a six-minute walk -- of an automated external defibrillator location.
The study was slated for presentation Friday at the annual meeting of the Society for Academic Emergency Medicine in Chicago.
It's been found that cardiac arrest victims' chances of survival fall by about 10 percent with each minute that passes without CPR and defibrillation. Patients who receive an automated external defibrillator shock six minutes or more after suffering a cardiac arrest have very low survival rates.
"AEDs are an essential part of the 'chain of survival' that's necessary to save cardiac arrest victims," senior author Dr. Raina Merchant, an assistant professor of emergency medicine, said in a Penn Medicine news release. "Despite thousands of them in the community, our results show they are usually not readily available during cardiac arrests. Without an AED, the minutes bystanders spend waiting for paramedics to arrive could mean the difference between life and death."
The researchers said their findings highlight the need to place automated external defibrillators more strategically in communities and to develop new ways to help the public easily find them and use them in emergencies.
Because this study was presented at a medical meeting, the data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.
More information
The American Heart Association has more about automated external defibrillators.
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Blacks Less Likely to Get Help on Scene After Cardiac Arrest: Study
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Sooner Is Better for Controlling Obese Kids' Weight: Study
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Weight-Loss Surgery May Also Help Menstruation, Skin, Hair
"Obesity is a huge problem in the United States," said study author Chandhana Paka, a fellow in minimally invasive gynecological surgery at Stanford University School of Medicine. "We wanted to see if bariatric surgery
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Young cancer patients' 'Stronger' video a big hit
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NFL star Junior Seau celebrated at stadium memorial
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Venezuela's Chavez says Cuba treatment successful
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'Divide and conquer' unions comment dogs Wisconsin governor in recall
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