Health Highlights: July 23, 2005
Clinton Launches AIDS Initiative FDA Approves New Treatment for Insomnia Guidant Says Defibrillator Recommendation May Be Harmful Drug Industry Proposes Ad Revisions 6 Floridians Died From Generator Exhaust After 2004 Hurricanes
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Clinton Launches HIV/AIDS Initiative
Former President Bill Clinton on Saturday kicked off a program that will almost double the number of children in Kenya receiving HIV treatment by the end of 2005, the Associated Press reported.
About 100,000 children in that country are currently infected with HIV, according to the AP, but only 1,200 actually received treatment for their disease. The Clinton Foundation's Pediatric HIV/AIDS Initiative will target an additional 1,000 children.
After flying to Rwanda late Saturday, Clinton donated a year's supply of anti-retroviral treatment for 2,500 children in that country. The foundation's goal is to have 10,000 HIV-infected children in at least 10 countries on anti-retroviral treatment by the end of the year. The money for the massive effort was raised by Clinton mostly from private donors, the AP said. Rwanda was the last stop on Clinton's tour of six African countries, the aim of which was to shine the spotlight on this continent's AIDS crisis.
Children account for one-sixth of HIV/AIDS deaths each year, but they represent only 5 percent of those treated worldwide, according to the United Nations.
FDA Approves New Treatment for Insomnia
A new treatment for insomnia was approved on Friday, and it bears the distinction of being the first prescription sleeping aid not to be classified as a controlled substance.
The drug, known as Rozerem (ramelteon), works differently than its competitors, the Associated Press reported. It is a chemical cousin of melatonin, a natural hormone that keeps the body's sleeping/waking cycle in balance. Rozerem appears to stimulate melatonin receptors in the brain, Dr. Robert Meyers, of the U.S. Food and Drug Administration, told the AP.
Studies have also shown the drug does not cause dependence, which is why the FDA did not classify it as a controlled substance. However, the medication is metabolized by the liver, so those with liver conditions should not take this drug, Meyer added.
Rozerem should be available in late September, although its maker, Takeda Pharmaceuticals, would not reveal a price. Roughly a third of adults have trouble sleeping, and about 10 percent have trouble functioning during the day, the AP reported.
Guidant Says Defibrillator Recommendation May Be Harmful
Guidant Corp. said Friday that one of its recommendations designed to correct a problem with its implantable heart defibrillators may actually increase risk to patients.
The Indianapolis-based company had recalled 11 models of its defibrillators last month, affecting about 88,000 devices, because of malfunctions in the pacemaker-like devices. The malfunctions occurred when a magnetic switch inside the device got stuck and prevented the device from providing treatment. Defibrillators shock the heart back into a normal rhythm when they detect abnormal heartbeats.
Guidant said Friday that it has now changed its advice to doctors treating about 21,000 patients with implanted Ventak Prism AVT, Vitality AVT, and Contak Renewal AVT defibrillators, according to the Associated Press.
In other Guidant news, the U.S. Food and Drug Administration on Friday classified the company's recent decision to pull back nine models of pacemakers it sells as a Class 1 recall. A seal within the devices can leak, letting in moisture that can disrupt the electrical circuitry. That can lead to unexpected failure or rapid heart rates. The affected models were made between Nov. 25, 1997, and Oct. 26, 2000.
As for the defibrillators, the company had told doctors in June to make a programming change to the devices, which malfunctioned in two reported cases. However, the company found that a third event occurred after the original warnings went out despite the programming recommendation. The patient was not injured beyond having to have the device replaced.
In a "corrective action" letter to doctors Friday, the company warned, "Guidant has determined that one of our original recommendations -- programming Atrial Tachy Episode Data Storage to 0 percent -- can cause latching in a subset of AVT devices that have previously stored atrial episode data." Instead, the letter said, doctors "as soon as possible" should call back any patients who were reprogrammed to 0 percent or less than 20 percent and program the data storage to 20 percent.
Drug Industry Proposes Ad Revisions
The pharmaceutical industry has proposed new guidelines that call for educating doctors about new drugs before ads for them are released.
But the draft code stops short of setting a time span between a drug's release and the beginning of ads, as had been called for by industry critics who say doctors need time to understand drugs before patients start asking for them, The New York Times reported. The guidelines say only that drug makers should have "conversations with physicians" before advertising new products.
The guidelines, whose final wording is still being worked out, try to address growing pressure from a variety of fronts, including Capitol Hill and the American Medical Association, and even from within the industry itself.
A large consumer group reacted on Thursday with skepticism to the industry guidelines. "It appears the pharmaceutical industry has produced a placebo rather than supporting real reform of drug advertising," said Rob Schneider of Consumers Union, who called the guidelines primarily a good-will gesture aimed at calming Congress.
Details of the code will be disclosed at a news conference next month, the newspaper reported.
The guidelines, adopted unanimously by the Pharmaceutical Research and Manufacturers of America's board Thursday, also call for TV ads appropriate for the audience and age, ads that promote disease awareness, and ads that notify patients about low-cost drugs for the uninsured.
6 Floridians Died From Generator Exhaust After 2004 Hurricanes
At least six people in Florida were killed by portable generator exhaust in the wake of last year's four major hurricanes that left millions without power, the U.S. Centers for Disease Control and Prevention said in a report released Thursday.
Misplacement of the gasoline-powered generators led to the carbon monoxide (CO) deaths of at least six people and caused non-fatal cases of CO poisoning in at least 167 others, the agency said in its Morbidity and Mortality Weekly Report.
The CDC said the tolls may have been higher because it measured statistics from a sample of 10 hospitals. Between Aug. 13 and Sept. 25 last year, the state was battered by a record four major hurricanes: Charley, Frances, Ivan, and Jeanne.
The agency reminded the public that these generators should never be used indoors, in garages, or outdoors near windows. A typical 5.5 kW generator produces as much carbon monoxide -- an odorless, colorless gas that can kill within minutes -- as six idling cars, the CDC said. Symptoms of CO poisoning include headache, nausea, dizziness, vomiting, shortness of breath, and loss of consciousness.
In a related report, the CDC said 48.7 percent of Florida residents had no evacuation plan before any of the hurricanes; this included people in the direct paths of the storms. The agency called on the state and local governments to do a better job of devising hurricane-preparedn