FDA Panel Endorses Celebrex for Kids
A bid by Pfizer Inc. to expand U.S. approval of its painkiller Celebrex to include treatment of children with juvenile rheumatoid arthritis (JRA) was approved by a U.S. Food and Drug Administration advisory panel on Wednesday.
The panel, a committee of doctors and other specialists, voted 15-1 that the benefits of the drug in children outweigh the shortage of sufficient proof on its safety, Bloomberg reported.
The panel, meeting in Gaithersburg, Md., raised concerns related to the risks of longer-term use and said a registry should be established to track patients.
It's estimated that as many as 60,000 children in the United States have JRA, which causes painful joint swelling and can affect growth and development, the Associated Press reported.
Currently, Celebrex is approved to treat adults with osteoarthritis and rheumatoid arthritis. In its application to expand that approval to include treatment of JRA, Pfizer included a study that concluded that Celebrex (also called celecoxib) works as well as naproxen in treating young JRA patients.
However, FDA documents released Tuesday noted that limitations in the study's design "raise questions about whether it provides adequate evidence of efficacy of celecoxib" in treating JRA, the AP reported.
Celebrex is a member of the controversial group of painkillers called Cox-2 inhibitors, which have been linked to an increased risk of heart attack and stroke.
Two other Cox-2s, Vioxx and Bextra, have been withdrawn from the market due to heart-risk concerns. Celebrex remains available to consumers, but the FDA required in 2005 that the drug carry a "black box" warning, detailing the possible risk of heart attack or stroke.
Study Looks for Genes That Cause Early Atherosclerosis
A number of U.S. medical centers are taking part in a $10 million multi-year study to identify genes that contribute to early atherosclerosis, which increases the risk of heart attack and stroke.
Atherosclerosis is the development of fatty deposits in arteries.
"If we can identify people in their teens and early adult life who have a genetic predisposition to develop atherosclerosis, we can manage their risk factors for heart disease and stroke sooner and more aggressively," Dr. David Herrington, professor of cardiology at Wake Forest Baptist Medical Center in Winston-Salem, N.C., said in a prepared statement.
The study, called SEA (SNPs and Extent of Atherosclerosis) is being funded by the U.S. National Heart, Lung, and Blood Institute.
"We hope the SEA study will give us new understanding about the causes of atherosclerosis, including the discovery of new genes and new pathways that could guide the development of new drug treatments that may be more effective in preventing the development of heart disease," Herrington said.
He and his colleagues will analyze data collected in two large, previous studies. It's estimated it will take about five years to complete the SEA study.
Along with Wake Forest, other medical centers taking part in the study include Cedars Sinai Medical Center; Louisiana State University Health Sciences Center in New Orleans; the University of Texas Health Science Center at Houston; and the University of Washington.
Arby's to Cut Trans Fats
Arby's has joined other major fast-food chains in reducing artery-clogging trans fats in their products.
On Tuesday, Atlanta-based Arby's Restaurant Group said that, as of May 1, 2007, its outlets would no longer serve french fries with trans fats, and that 75 percent of its menu items would contain less than half a gram of trans fats, the Associated Press reported.
Arby's, which has more than 3,500 restaurants worldwide, will stop using the hydrogenated oils that contain trans fats and the company's food suppliers will no longer precook Arby's french fries in oil with trans fats.
Within the past few months a number of major fast-food chains -- such as Wendy's, KFC and Taco Bell -- have announced they're eliminating or reducing trans fats in their food products, the AP reported.
Several U.S. cities are considering banning trans fats, which are believed to increase the risk of heart disease.
Flu Viruses Survive in Ice for Decades
Influenza viruses can remain dormant for long periods of time in ice and potentially cause illness when the ice thaws, says an Ohio State University biologist.
Scott Rogers and his Israeli and Russian colleagues concluded that flu viruses can be preserved in ice for decades and then be released when humans may no longer have a natural immunity against them, United Press International reported.
"We've found viral RNA in the ice in Siberia, and it's along the major flight paths of migrating waterfowl" that travel between North America, Asia and Australia. These paths also interconnect with other migratory paths to Africa and Europe.
The research appears in the December issue of the Journal of Virology.
Medicare Drug Benefit Well Under Budget
The U.S. Medicare drug benefit came in well below budget this year -- $30 billion instead of $43 billion -- according to figures provided to the Associated Press by the federal Centers for Medicare and Medicaid Services.
While supporters of the drug benefit may say the lower costs are the result of competition, critics take another view.
"Republicans would have you believe that the drug and insurance companies have sacrificed profits in the name of competition, but nothing could be further from the truth," Rep. Pete Stark (D-Calif.) told the AP. "In fact, the dirty little secret is that costs are lower because of low enrollment and a slowdown in drug spending."
Sources of the savings included: lower than expected enrollment, $7.5 billion; competition between drug plan providers, $6.9 billion; a lower-than-expected increase in drug prices in the two years before the launch of the benefit, $3.7 billion, the AP reported.
Democrats say they can cut costs even more by changing laws that prohibit the government from directly negotiating drug prices with pharmaceutical companies on behalf of Medicare beneficiaries.
Study Finds Why Cox-2s Increase Heart Attack, Stroke Risk
British researchers say they've discovered why Vioxx and other Cox-2 inhibitor painkillers can cause heart attacks and strokes, BBC News reported.
It's because these drugs -- designed to block the Cox-2 enzyme and halt production of hormones that swell joints and cause pain in people with arthritis -- also stop an enzyme called Cox-1 from producing blood-thinning agents. This results in a greater risk of blood clots.
The study appears in the Federation of American Societies for Experimental Biology Journal.
The researchers said their findings are significant because they may lead to the development of Cox-2 inhibitors that do not increase the risk of heart attack and stroke, BBC News reported.
"Cox-2 inhibitors can have great benefits for patients suffering from conditions such as arthritis and it would be great if they could remain available," noted study co-author Professor Jane Mitchell of the National Heart and Lung Institute.