FDA Knew of Heart-Device Problems Before Releasing Alert: Report
The U.S. Food and Drug Administration received a report last February about problems with implanted heart defibrillators made by the Guidant Corp. but didn't issue a safety alert until June, The New York Times reported Monday.
The report from Guidant contained data showing that one of its most widely used defibrillator models -- the Ventak Prizm 2 DR -- was suffering a short-circuit rate of about one a month. A month after the FDA received the report, a U.S. college student who had this model defibrillator died of sudden cardiac arrest.
Defibrillators are designed to deliver electric jolts to the heart to control irregular heart rhythms.
The FDA didn't make the data public when it received it because the agency treats the information in such reports as confidential, the Times reported. The agency's policy is to review these reports within 90 days of receiving them. However, it's unclear whether the Guidant report was reviewed within this time frame or how FDA regulators first interpreted the data in the report, the newspaper said.
The Guidant controversy prompted a meeting of heart specialists that's scheduled for this Friday in Washington, D.C. One of the major issues expected to be discussed is how much medical device safety data should be disclosed to doctors and patients, the Times reported.
Older People's Memory Hindered by Inability to Ignore Distractions
An inability to tune out distractions is the major reason why older people suffer memory problems, says a University of California, Berkeley study in the journal Nature Neurosciences.
Researchers used brain scans to compare the ability of younger adults (19 to 30) and older adults (60 to 77) to concentrate. The results showed that older people had no difficulty focusing on relevant information but weren't as able as younger adults to tune out competing distractions.
"Difficulty filtering out distractions impacts a wide range of daily life activities, such as driving, social interactions and reading, and can greatly affect quality of life," lead researcher Dr. Adam Gazzaley told BBC News.
"These results reveal that efficiently focusing on relevant information is not enough to ensure successful memory. It is also necessary to filter distractions. Otherwise, our capacity-limited short-term memory system will be overloaded," Gazzaley said.
Fellow researcher Professor Mark D'Esposito told BBC News: "If you are unable to block out distracting information, you can't really attend to what you are supposed to attend to, you can't get in what you are supposed to remember, and you have a hard time retrieving what you are supposed to remember."
Super-resistant E. Coli Germ Spreading Across Britain
A new super-resistant form of E. coli bacteria is spreading across Britain and has infected thousands of people and caused numerous deaths, says a report released Monday by the government Health Protection Agency (HPA).
This new E. coli strain was unknown before 2000 but began spreading rapidly in 2003, The Independent newspaper reported. This "superbug" causes blood poisoning in vulnerable people and is resistant to treatment with conventional antibiotics.
Outbreaks have been reported in Shrewsbury (300 cases of infection in 18 months) and in Southampton (1,000 cases of infection since 2003).
Attempts to control this strain of E. coli have been unsuccessful and it has spread across the country, the report said. People in the community as well as hospital patients are being affected.
The report is meant to alert doctors and hospital staff to improve laboratory reporting and surveillance of this infection.
Bats May Be Source of SARS Virus: Report
Chinese researchers say they've found a virus in some wild bats in Hong Kong that's closely related to the virus that causes Severe Acute Respiratory Syndrome (SARS) in humans.
In 2003, Chinese health officials first found the SARS coronavirus in caged civets in animal markets, suggesting these weasel-like mammals were the source of the SARS epidemic. But, subsequent studies suggested that while civets have served to host the virus, they may not have been the original host.
To investigate further, the Chinese research team studied wild animals in the Hong Kong countryside that may have come in contact with civets. The researchers found a coronavirus similar to the SARS virus in nearly 40 percent of wild Chinese horseshoe bats they examined. A genetic analysis of the bat coronavirus showed the virus is closely related to the human SARS coronavirus. And it probably shares a genetic ancestor with the civet SARS coronavirus, the researchers said.
Their findings appear in the online early edition the Sept. 12-16 edition of the Proceedings of the National Academy of Sciences.
The researchers said they couldn't determine how the bats were originally infected or whether this species was responsible for transmitting the SARS coronavirus to other mammals, including civets. However, since bat feces are used in Chinese traditional medicine, and bat meat is considered a delicacy in parts of Asia, the researchers urged caution in handling these animals.
SARS first appeared in southern China in late 2002. It has killed 774 people around the globe, most of them in Asia, according to the World Health Organization. More than 8,000 people were sickened before the initial outbreak was brought under control through such measures as quarantines and travel restrictions. But health officials worry about the potential for another outbreak.
Encephalitis Kills Nearly 700 Children in India
An outbreak of Japanese encephalitis has killed nearly 700 children in the Indian state of Uttar Pradesh, according to official figures, although aid agencies say the real toll could be closer to 1,500, BBN News reported.
The outbreak began earlier this summer with the onset of monsoon rains. The virus is transmitted by mosquitoes; they transfer it from infected animals -- usually pigs and birds -- to humans.
The disease leads to high fever and aching. Victims eventually fall into a coma and nearly one-third of them die, the BBC said.
FDA Panel Backs Diabetes Drug, Despite Heart Risks
Experts advising the U.S. Food and Drug Administration voted Friday to recommend FDA approval of the Bristol-Myers Squibb diabetes drug Pargluva (muraglitazar), despite an increased risk of heart failure among users, the Bloomberg news service reported.
Pargluva is among a new class of non-insulin drugs that allows diabetics to control blood sugar levels. It's also designed to help patients maintain healthy blood cholesterol levels. But there were 17 cases of heart failure among Pargluva users in clinical trials, compared with two cases of heart failure among those who took a different drug, Bloomberg said.
The consumer group Public Citizen warned against FDA approval, citing the drug's heart failure risks and two other common side effects, fluid retention and weight gain. Bristol-Myers argued that the drug's benefits outweigh its risks.
A company spokesman told Bloomberg that the company would address the heart failure risks.
Health Tip: Treating Shin Splints
Shin splints are usually caused by inflammation or injury to the shin muscles. The predominant symptom is a sharp, searing type of pain along the bone of your lower leg.
The Calgary Health Region of Canada offers these self-care tips:
Rest the affected leg as much as possible.
Substitute non-weight bearing exercises, such as swimming, for your usual workout until the pain has gone.
Do daily calf muscle and Achilles tendon stretches but avoid stretching the shin muscles.
Apply ice to the inflamed area.
Wrap your lower leg with a tensor bandage to provide support.
Elevate the lower leg above the level of your heart as often as possible.
The pain from shin splints can last from several days to a week, but may become chronic if you don't allow enough time for your leg to heal.
Health Tip: Breathe Easier Indoors
Since most people spend more time indoors than out, the air quality of the indoor environment can play an important role in maintaining good health, according to Health Canada.
Here's how to keep indoor air quality healthy:
Control the humidity and let more air into your home to prevent moisture from building up on walls and windows.
Repair leaky roofs, walls and basements.
Get rid of moldy surfaces with a solution of bleach and water -- about one cup of bleach per gallon of water.
Keep your home clean and dust-free.
Buy a hygrometer to measure indoor humidity. This way you'll know whether you need a humidifier.
Regularly clean and disinfect humidifiers and air conditioners.
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