Friday, July 6, 2012
Over-the-counter HIV test approved
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US approves over-the-counter HIV home testing kit
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FDA approves first rapid, take-home HIV test
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FDA Approves First At-Home HIV Test
The test, called OraQuick(R) In-Home HIV Test, involves swabbing the gums, placing the swab into a vial, and then seeing the results within 20 minutes, the agency said in a statement.
The test kit's approval could herald a new era in HIV prevention, experts say. According to the CDC, more than 1.2 million Americans carry the virus that causes AIDS, but about one in five are unaware that they are infected and can pass HIV on to others.
"Knowing your status is an important factor in the effort to prevent the spread of HIV," Dr. Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in the statement. "The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate."
The move comes two months after a 17-member FDA advisory panel voted unanimously that the benefits of the test were greater than any possible risks.
OraSure Technologies Inc., which makes the over-the-counter test, already sells a version of it to doctors and other health professionals. Studies have shown the test was less accurate when used by consumers, but the FDA advisory panel agreed that the benefits of expanding HIV testing still outweighed a small drop in test accuracy.
Dr. Nitika Pant Pai, an assistant professor of medicine at Montreal's McGill University, said that "by making self tests available over the counter, a stigmatized HIV diagnosis will be normalized to some extent."
She added that, "individuals are not averse to the test, but to the process of testing. With an oral test that is convenient, noninvasive and highly accurate in the hands of a trained user and fairly accurate in the hands of an untrained user, individuals will be motivated to seek testing." Pai co-authored an analysis of the effectiveness of an at-home HIV test earlier this year.
The test, which looks for signs of HIV in oral fluid, is already used at hospitals and doctors' offices where medical professionals administer it. The FDA first approved that use in 2004.
To take the OraQuick test, people swab their outer gums and put the swab into a vial. After about 20 minutes, the test device will reveal two reddish-purple lines in a small window if there are signs that the body's immune system has geared up to battle HIV.
The test uses oral fluid, which is not the same as saliva. Its results are considered preliminary, and should be confirmed by a blood test.
OraSure had nearly 5,700 people take the at-home version of the test. The tests found that 114 thought they were HIV-positive; 106 of them actually were. That means that positive results were accurate 93 percent of the time. Negative results were accurate 99.98 percent of the time, the company said.
Pant Pai said the oral test's overall accuracy is similar to that of a blood test, although it's slightly less accurate. The oral test, in particular, may miss HIV infection in its early stage. "Self test will be a first step -- you will always need confirmation of a preliminary HIV diagnosis," she said.
Also, "the sensitivity of the test appears lower when administered in the home setting rather than a medical setting, so some of the people who are HIV-positive will get a test result that they are negative," Jane Rotheram-Borus, director of the Center for HIV Identification Prevention & Treatment Services at the University of California, Los Angeles, said in May. "However, if they would otherwise not have gotten the test at all, they may also have believed they were negative."
Experts have expressed concern for people who learn at home, possibly alone, that they are probably infected with the virus that causes AIDS.
"The arguments against the at-home test focus on the absence of a counselor who could provide support and link the newly identified HIV-positive individual to medical care," said Rotheram-Borus, who supports over-the-counter sales of the OraQuick test.
She pointed out that "over-the-counter pregnancy tests are widely used, and pregnant women do find their way into prenatal care."
In a news release issued Tuesday, Orasure said it expects that the OraQuick test will become available in October at more than 30,000 retail outlets nationwide, as well as online. Orasure has also said that it will offer a 24-hour, toll-free number that people can call to get support regarding their test results.
More information
For more on HIV and AIDS, try the U.S. National Library of Medicine.
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Sleep apnea gets worse in the winter
People with the common sleep disorder stop breathing multiple times throughout the night, each bout lasting from seconds to minutes.
Jerome Dempsey, who studies breathing problems at the University of Wisconsin and was not involved in the new study, said it makes sense that airway infections and weather would have an effect on sleep apnea.
But the changes in sleep apnea across seasons are small, Dempsey added, and the study does not prove that winter weather in itself makes sleep apnea worse.
According to the National Heart, Lung, and Blood Institute, one in 10 adults over age 65 has sleep apnea.
Seasonal changes in weight and allergies can affect sleep apnea, and the Brazilian researchers, led by Cristiane Maria Cassol at Universidade Federal do Rio Grande do Sul, wanted to see if weather changes might also have any impact on the disorder.
They used data from patients who came in for testing at a sleep clinic on how many times their sleep was disturbed by breaks in breathing. The study included one night of sleep for more than 7,500 patients over a 10-year period.
The researchers then compared the severity of the patients' apnea to the weather conditions at the time, including humidity, temperature and air pollution.
Patients who came in during the colder months had more nighttime breaks in breathing than those who sought treatment during the warmer months. For instance, during the winter, patients stopped breathing an average of 18 times per hour, compared to 15 times an hour during the summer.
Similarly, the sleep clinic was more likely to see the most severe cases - people who stopped breathing more than 30 times an hour - in the colder months.
About 34 percent of patients who came in during cold weather had severe apnea, while 28 percent of patients during warm weather had severe apnea.
The team found that certain weather conditions - high atmospheric pressure and humidity and high levels of the air pollutant carbon monoxide - were tied to worse cases of apnea.
But the study could not determine whether it's the weather that's responsible for the more severe sleep apneas.
The researchers write in their report, published in the journal Chest, that more severe apnea in the winter "can be due to several circumstances, including winter-related upper-airway problems that intensify the severity of (sleep apnea) symptoms."
Another possibility is that wood burning to heat homes during the winter can cause irritation in the airways and aggravate sleep apnea.
"There are so many things that affect sleep apnea, including the decision of when to come visit" a sleep clinic, Dempsey told Reuters Health.
In other words, it might not be the weather, but the time of year that makes it more convenient for patients to take the time to seek treatment.
Dempsey said researchers would have to follow patients for at least a year and observe how their conditions change in order to say whether sleep apnea really does worsen in the winter.
While winter-related conditions such as colds or allergies might intensify sleep apnea, Dempsey said the biggest risk factor is obesity.
SOURCE: http://bit.ly/MqNmmE Chest, online June 14, 2012.
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Fireworks for the Physicists: A Higgs is Found
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Photos: Pencil Removed from Tot's Brain
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Flesh-Eating Victim's Home Makeover
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Half of all heart patients make medication errors
Consequences of mistakes - such as forgetting to take certain drugs or taking the wrong dose - can range from side effects like constipation to more serious drops in blood pressure. Two percent of errors were life-threatening.
Hospitals involved in the study were already taking steps to prevent medication mistakes in addition to the extra pharmacist intervention, said Dr. Sunil Kripalani, the study's lead author from the Vanderbilt University Medical Center in Nashville, Tennessee.
"We were surprised to see that in spite of these efforts that 50 percent (of patients) were still having these medication errors," he told Reuters Health.
Although the pharmacist visits didn't help the average patient, he added, certain ones seemed to benefit - such as patients who were on multiple drugs or had trouble understanding health information.
As for traditionally lower-risk patients, he said other strategies to prevent errors may be needed.
ONE-ON-ONE MEETINGS
For their study, Kripalani and his fellow researchers followed patients who had been hospitalized for heart conditions at Vanderbilt University Hospital and Brigham and Women's Hospital in Boston.
Half of the patients were randomly assigned to attend two visits with a pharmacist, who looked at which medications patients were taking and instructed them on what to do once they left the hospital to manage their prescriptions and reduce side effects.
The patients also received tools, such as a medication chart and pillbox, to use at home.
After leaving the hospital, the patients received a phone call within a few days from one of the study's coordinators who was able to identify medication-related problems over the phone. If any were found, a pharmacist made a follow-up call.
The other heart patients did not receive any special treatment outside of normal hospital procedure, which is for a nurse or doctor to spend a few minutes with patients before they leave the hospital to discuss their medications.
One month later, 432 out of the 851 patients had made at least one harmful or potentially-harmful medication error, including missing doses, taking the incorrect dose, stopping a drug too early or continuing it for too long.
Just under one-quarter of those errors were judged to be serious and about two percent were life-threatening. And there was no difference in the number of errors made by patients who did or didn't get extra pharmacist advice.
One limitation, the researchers note in their Annals of Internal Medicine report, is that not all patients in the intervention group had two pharmacist visits or a follow-up call as intended. It's also unclear whether the findings would apply to patients being treated for other, non-heart conditions.
KEEP A LIST
Kevin Boesen, director of the Medication Management Center at the University of Arizona College of Pharmacy in Tucson, told Reuters Health he's not surprised that many people are confused after leaving the hospital.
"To me, I think (the finding) highlights the challenge for the transition from hospital to home," he said.
Boesen added that it's important for patients to meet with their regular pharmacist and primary care doctor after they get out of the hospital or fill a prescription somewhere else.
"I think there is the assumption that when a patient goes to a pharmacy the pharmacist will have a list of all the medication they're on," he said. But that's not always the case.
A key safety step patients can take, Boesen and Kripalani agreed, is to keep track of all of the drugs they're taking and carry a list.
"The single most important thing patients and families can do to promote safety with their medications is to always keep a medication list with them," Kripalani said. That list should include drug doses and patients' reason for taking each medication, he added.
"If a patient simply carries that medication list, so everyone is working off of one list, that definitely helps," said Boesen.
SOURCE: http://bit.ly/P65Kp7 Annals of Internal Medicine, online July 2, 2012.
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'Ted' Joke Offends ALS Patients
A punch line from the movie "Ted" has people with Lou Gehrig's disease crying foul.
"From one man to another, I hope you get Lou Gehrig's disease," Mark Wahlberg's "John" says to his foul-mouthed teddy bear friend -- a quip some patients say crossed a line.
"I didn't expect to go to a movie and sit with an audience laughing at the expense of people with ALS," said Randy Pipkin, who was diagnosed with Lou Gehrig's disease in 2005. "I think the message this film sends out is a huge slap in the face to people dying from this horrific disease."
Lou Gehrig's disease progressively robs people of their ability to move, speak, eat and breathe. There is no cure.
"This line from Ted is something that never should have been said much less survived the editing process for a major movie release especially as a punch line for a comedy," Jeff Lester, an ALS patient from Lebanon, Mo., wrote in an open letter to Wahlberg and "Ted" writer Seth MacFarlane posted on Facebook.
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Thursday, July 5, 2012
From a vial of mom's blood, a fetus's entire genome
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Puerto Rico sees sharp spike in dengue cases
The territory's Health Secretary Lorenzo Gonzalez says 111 cases were reported the first week of June and 117 cases the previous week. Eight cases of the more-severe hemorrhagic form have been confirmed, though no one has died.
A U.S. Centers for Disease Control report shows new infections running at a pace that has marked past epidemics. Dengue cases usually peak in early October.
Gonzalez said late Tuesday that detected cases may be rising because of new courses to help doctors identify symptoms.
The mosquito-borne virus causes fever, severe headaches and extreme joint and muscle pain.
Dengue claimed a record 31 lives in Puerto Rico during a 2010 epidemic.
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