Health Highlights: March 2, 2004
FDA Aims to Boost Generic Drug Development Scientists Complete Chicken Genome New Guidelines To Limit Antibiotics for Ear Infections Report: Bonds, Giambi Received Steroids NIH Halts HRT Trial Increasing Antibiotic Resistance Seen in Common Bacteria
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
FDA Aims to Boost Generic Drug Development
The U.S. Food and Drug Administration announced Tuesday new measures it says will improve patient access to generic drugs.
In a news release, the agency said it will provide more public information in order to help generic drug applicants determine if they qualify for 180-day marketing exclusivity for products.
That marketing exclusivity provides an incentive for generic drug development. Access to more information will help generic drug manufacturers to better plan development of additional generic products, the FDA says.
"The steps we are announcing today will further spur the development and availability of generic drugs, which are an increasingly important way to provide the American people with safe, effective, and affordable medical treatment," FDA Commissioner Dr. Mark B. McClellan says in a prepared statement.
Scientists Complete Chicken Genome
An international team of scientists has mapped the domestic chicken's genetic code and published it in a free database so that it can be accessed by biomedical and agricultural researchers.
The mapping outlines variations between three different strains of layer and broiler chickens from China, Sweden, and the United Kingdom, CBC News Online reports.
In a related development, scientists at the U.S. National Institutes of Health announced they'd completed the genome of the red jungle fowl, the ancestor of domestic chickens.
Recent outbreaks of avian flu highlight the importance of learning more about the chicken genome and how certain genetic variations may resist the virus that causes the disease.
Information about the chicken genome may also improve poultry breeding and food safety. Chickens are also used in research into embryo development and the link between viruses and some cancers.
New Guidelines To Limit Antibiotics for Ear Infections
The American Academy of Family Practice and the American Academy of Pediatrics are expected to recommend this spring that doctors refrain from using antibiotics to treat most middle ear infections in children.
Even though such a recommendation runs counter to years of pediatric practice, health officials feel it may help reduce the proliferation of antibiotic-resistant germs resulting from overuse of the drugs, the Associated Press reports.
Most of the antibiotics that doctors prescribe for children are for the treatment of ear infections. Under the new guidelines, antibiotics would be prescribed only for children with serious middle ear infections. Doctors would simply monitor milder ear infections.
The new guidelines must be formally approved by both medical groups before they're published, the AP says.
Report: Bonds, Giambi Received Steroids
U.S. investigators were given information that baseball sluggers Barry Bonds and Jason Giambi, among others, received steroids from a nutritional supplements lab implicated in a distribution ring, the San Francisco Chronicle reports.
The information given to the investigators also claims that Gary Sheffield, now Giambi's teammate with the New York Yankees, three other Major League Baseball players, and one National Football League player received steroids from the lab.
It's alleged the players were given the illegal performance-enhancing drugs by Greg Anderson, a longtime friend of Bonds and his personal weight trainer, the paper reports. The steroids reportedly came from the Bay Area Laboratory Co-Operative, and date back to the 2001 season, when Bonds obliterated the single-season home run record by slugging 73.
Bonds has won a record six National League Most Valuable Player (MVP) awards, including the last three years with the San Francisco Giants, and is in hot pursuit of the career home run record. Giambi was the American League MVP in 2000, when he was playing with the Oakland Athletics.
"We continue to adamantly deny that Barry was provided, furnished or supplied any of those substances at any time by Greg Anderson," Michael Rains, an attorney for Bonds, told the Chronicle.
Lawyers for the other players issued statements saying their clients never knowingly used steroids.
NIH Halts HRT Trial
U.S. health officials have halted another hormone replacement therapy trial.
The U.S. National Institutes of Health (NIH) announced Tuesday it had stopped the estrogen-only segment of the Women's Health Initiative (WHI). The decision was made after data indicated that estrogen-alone therapy increased stroke risk, HealthDayNews reports.
"The NIH believes that an increased risk of stroke is not acceptable in healthy women in a research study. This is especially true if estrogen alone does not affect (either increase or decrease) heart disease, as appears to be the case in the current study," an NIH statement explained.
The estrogen-alone study included 11,000 healthy postmenopausal women, aged 50 to 79, who had their uteruses removed in a hysterectomy. The study had been under way for nearly seven years before it was halted.
The U.S. Food and Drug Administration plans to assess the estrogen-alone study data to determine whether additional label changes for HRT are necessary.
Increasing Antibiotic Resistance Seen in Common Bacteria
A group of common bacteria are becoming resistant to antibiotics that have proved effective against them for decades, the New York Times reports.
Since the 1970s, Staphylococcus aureus (staph) infections in healthy people have been routinely and successfully treated with penicillin-like drugs. Staph are the most common cause of skin infections. These bacteria can also cause other infections in the lungs and bloodstream.
But the Times reports that primary-care doctors who use these penicillin-like drugs to treat staph infections may discover their patients get sicker instead of healthier.
These resistant staph strains are more invasive and more pervasive than the staph strains that most primary-care doctors are used to treating, infectious disease expert Dr. John Gullett told the Times.
Other infectious disease experts expressed concern about these antibiotic-resistant staph bacteria and said many primary-care doctors are not aware of them.