A cap that chills the brains of oxygen-deprived newborns was given a preliminary blessing by a group of scientific advisors for the FDA, which ruled on Friday that the device might help prevent brain damage in these infants.
The Associated Press reported that the ruling moves the "Cool-Cap" closer to market, although the advisors noted the device would have to be sold under strict conditions to guarantee the technology doesn't cause harm.
The FDA does not have to follow the recommendations of its advisors, but it usually does, according to the AP. Mild hypothermia, where the body is cooled by only a few degrees, has improved the chances of complete recovery in adult heart attack patients. The procedure reduces the brain's need for oxygen, and stalls a cascade of events that can lead to further damage once blood flow returns to the brain.
The cap, which is strapped to the newborn's head, has water channels running through it. Cold water rushes through the cap for 72 hours, causing the baby's temperature to drop to 94 degrees. Afterwards, the newborn's body temperature is restored to normal levels. In research on 218 newborns, 45 percent of those treated with the cap survived without brain damage, compared to 34 percent of the babies who were given standard treatment.
Medical Marijuana Available in Oregon Again
Oregon has begun issuing medical marijuana cards again, after the state's attorney general decided to ignore a Supreme Court ruling that would allow federal prosecution of those possessing the drug.
At the same time, the Associated Press reported, the state warned that those who participate in the program will not be protected from prosecution if the federal government decides to take action. Last week, the Supreme Court ruled that federal drug laws supersede medical marijuana laws in the 11 states that have them. Oregon stopped sending out cards, but continued to process applications while Oregon Attorney General Hardy Myers examined the legal ramifications of the ruling, the AP reported.
Myers concluded that the Supreme Court decision did not invalidate Oregon's medial marijuana program, so the state's Human Services Department on Friday began mailing out about 550 registration cards. The AP reported that more than 10,000 patients have registered for the state's medical marijuana program. A doctor has to state that a patient needs the drug for pain relief from cancer, glaucoma, AIDS or severe pain, among other things.
Number of Babies Born HIV Positive Plummets in Florida
In a sign that the battle against AIDS is being won one at least one front, Florida reported Friday that the number of babies being born HIV positive has dropped dramatically in the past 10 years.
As a matter of fact, there have been no babies born HIV-positive so far this year in the state, the Associated Press reported. Florida Health Secretary John Agwunobi said the startling statistics show that more pregnant women are getting tested and that antiretroviral drugs used both during pregnancy and childbirth are making a difference.
"It's a huge AIDS success story," Florida Department of Health's HIV/AIDS Bureau Chief Tom Liberti told the AP.
The trend may be similar nationwide, although the U.S. Centers for Disease Control and Prevention doesn't have figures that are as fresh as the Florida statistics. However, mother-to-baby transmission of the virus in 2000 was down about 80 percent from its peak in the early 1990s.
Guidant Recalls 50,000 Heart Defibrillators
The FDA and Guidant Corp. are recalling 50,000 implantable cardiac defibrillators that may malfunction, the company announced Friday. Most of the devices have already been implanted, the Associated Press said.
Defibrillators shock an irregularly beating heart back into a normal rhythm. Guidant models recalled include the Prizm 2 DR, Contak Renewal, Contak Renewal 2, Ventak Prizm ADT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT. The company said it has at least 45 reports of failure, resulting in at least two recent deaths, the AP reported.
The company has come under fire for failing to alert doctors to the potential problems, and for allegedly selling older models for months after redesigning the way they were made. Guidant told The New York Times that it continued to sell the older models because it believed the devices were reliable, HealthDay reported June 2.
Guidant advises anyone who received an affected model to see their doctors at least every three months, and to consult their doctor immediately if they've received a defibrillator shock, the AP said.
FDA Limits Access to Lung Cancer Drug
The FDA has approved new labeling for the last-chance lung cancer drug Iressa (gefitinib), saying that after Sept. 15 the medicine should be limited only to patients who are already benefiting from its use, the agency announced Friday.
The AstraZeneca drug, approved in May 2003 for people with non-small cell lung cancer, failed to significantly extend survival among participants in 1,692-patient clinical trials. Only about 10 percent of users responded to it, the FDA said, noting that later research indicated the drug seemed to work better in people with a specific gene mutation.
Since Iressa's approval, a newer medicine -- Genentech's Tarceva (erlotinib) -- in the same class of drugs was shown to improve overall survival, the FDA said.
Some 4,000 Americans are taking Iressa, the Associated Press reported. It was approved under an FDA program that lets promising therapies sell before researchers ultimately determine whether they improve patient survival, the AP said.
People Over Age 50 Should Take Daily Aspirin: Study
Daily, low-dose aspirin should be taken by people 50 years and older to reduce their risk of heart attack and stroke, says an article in the British Medical Journal.
"The possibility that a simple, daily, inexpensive low-dose pill would achieve a reduction in vascular events, and might achieve reductions in cancer and dementia without the need for screening, deserves serious consideration," Peter Elwood, chairman of the Welsh Aspirin Group at Cardiff University in Penarth, Wales, said in a prepared statement.
He and his colleagues concluded that by age 50, 80 percent of men and 50 percent of women reach a risk level for heart attack and stroke that requires daily aspirin. They said that between 90 percent and 95 percent of people could take low-dose aspirin without experiencing any problems, Bloomberg news reported.
The Welsh Aspirin Group was established by the Aspirin Foundation to promote the use of aspirin.
Colin Baigent of the Oxford Radcliffe Infirmary expressed concerns about the use of daily, low-dose aspirin to prevent heart attack and stroke.
"A recommendation that aspirin be used for primary prevention of vascular disease in unselected people over a certain age could result in net harm, and we must have very good evidence to the contrary before instituting such a policy," Baigent wrote in the same issue of the journal.
Food Fact: Protect your baby!
Moms-to-be need to keep certain foods off-limits. Alcohol, caffeine and artificial sweeteners top the list; take a timeout until after your pregnancy. Ditto for soft cheeses (feta, goat, brie, camembert, blue-veined cheeses such as Roquefort, and all cheeses with unpasteurized milk or milk products; raw, rare or smoked fish, poultry or meat (sushi, tartar, carpaccio, smoked salmon); deli meats and cold cuts; and fish with high mercury levels.
Fitness Tip of the day: Easy steps for weight loss.
Want to burn 160 calories in 30 minutes? You don't even need a gym! All you have to do is walk -- a great way to tone up, decrease your risk of heart disease and colon cancer, and help control your weight. A 150-lb. person, walking briskly for 30 minutes, can burn 160 calories.
FAQ of the day: How does dairy fit into a diet?
They can make it easier -- or make it harder. The key is dairy fat, which, like all fat, has lots of calories. An 8-oz. glass of whole milk has 150 calories, while the same amount of fat-free milk has only 85. Similarly, a 1/4 cup of regular sour cream has 100 calories, while the same amount of fat-free sour cream has only 70. Your best bet is to make sure all your diary products are low-fat (no more than 3 grams total per serving) or fat-free.