Regulation of 'Off-Label' Drug Use Needs Improvement, Report Says
It can take up to a year for a pharmaceutical company to correct unapproved use of one of its drugs, according to a U.S. government report prepared for Congress.
According to the Associated Press, the practice of "off-label" use of drugs -- using them to treat diseases or conditions for which they were not approved -- has long been a "gray area of medical practice."
And, the wire service says, the report prepared by the U.S. Government Accountability Office (GAO) found that it can take an average of seven months for the U.S. Food and Drug Administration to issue a warning to the drug company. Then, according to the GAO report, it can take another four months before any corrective action is taken.
For example, Botox was first approved in 1989 to treat nervous disorders in eyelids. Although it wasn't approved for cosmetic use until 2002, hundreds of thousands of off-label wrinkle-removing treatments using Botox had already been conducted, according to the FDA.
How dangerous is off-label drug use? Dr. Randall Stafford, an associate professor of medicine at the Stanford Prevention Research Center, cautioned in an editorial in the April 3, 2008 issue of the New England Journal of Medicine that "off-label prescribing has become first-line therapy even in the absence of strong evidence of benefits and safety."
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Dramatic Rise in Obesity-Related Drugs Prescribed for Children
Obesity in U.S. children has created a market for prescription drugs normally associated with problems in adults, the New York Times reports.
Cholesterol-lowering drugs known as statins, along with high blood pressure medication and even type 2 diabetes and acid reflux drugs are being prescribed for hundreds of thousands of children, the newspaper reports.
The Times's findings come less than a month after the American Academy of Pediatrics -- a leading childhood physicians' organization -- had recommended that statins be given to some obese children at age 8.
The newspaper polled doctors about the number of prescription drugs in categories related to obesity that were being prescribed for young people and was told that the sale of these drugs accounted for less than one percent of all prescriptions in those categories. Nevertheless, the percentage increase over a seven year period was dramatic, according to the Times.
For instance, one pharmaceutical prescription service reported that the greatest increase occurred in drugs for Type 2 diabetes, with a 151 percent hike over seven years, the newspaper reported. Children's acid reflux prescriptions -- associated with obesity -- showed a 137 percent increase, the Times reported.
Nevertheless, many physicians interviewed by the Times still emphasized diet and exercise as the best way to bring obesity under control. "I worry that some providers and some families are looking for the quick fix, and are going to want to start medication immediately," Dr. Russell L. Rothman, an assistant professor at Vanderbilt University, is quoted as saying.
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Restaurant Trans Fats Ban Becomes Law in California
In what may be developing as a trans-continental competition to promote healthier eating, California has become the first state to ban restaurants from using trans fats for cooking.
A week ago, New York City became the first city in the United States to require major restaurant chains to post calorie content for all menu items. New York banned trans fats from being used by its restaurants last year.
According to the Associated Press, California Gov. Arnold Schwarzenegger signed legislation on Friday that ends restaurants' use of oils, margarine and shortening that contain trans fats, which have been linked to coronary artery disease.
The new law won't take effect until 2010, although trans fats have already been banned from being used in preparing food in California schools, the wire service said. Violation of the the law can result in fines of between $25 and $1,000, according to the A.P.
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Experimental Rheumatoid Arthritis Drug Appears Effective: FDA
Roche's Actemra (tocilizumab) appears to successfully treat the joint destruction and pain that accompany moderate-to-severe rheumatoid arthritis, the U.S. Food and Drug Administration said Friday in documents posted on its Web site.
But the drug has been linked to serious infections and cancer -- factors an FDA panel of experts will consider at its scheduled meeting Tuesday, when it decides whether to recommend the full agency's approval of Actemra, the Wall Street Journal reported.
More than 2 million Americans have RA, the newspaper said. Although there are many other treatments, they generally are limited to relieving pain. Actemra, by contrast, targets a receptor that plays a role in RA's acute inflammatory response, which leads to destruction of cartilage and bone that can trigger disability.
The FDA isn't bound to follow the recommendations of its expert panels, but generally does.
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EPA Bans Carbofuran Residue on Food
In what's regarded as a surprise move, the U.S. Environmental Protection Agency said it will no longer allow residue of the toxic pesticide carbofuran on domestic or imported food. The decision would effectively remove the chemical from the U.S. market, the Washington Post reported.
The EPA said Thursday it made the decision on the grounds that carbofuran residue on foods poses an unacceptable safety risk to toddlers.
The American Bird Conservancy and the Natural Resources Defense Council had been urging the EPA to forbid carbofuran residue on food because the chemical poses a threat to wildlife, as well as people, the Post reported.
"I was surprised and pleased the EPA did the right thing and followed the science. This is really a big one for workers, birds and bees," said Jennifer Sass, a senior scientist at the Natural Resources Defense Council.
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Custom Insoles Help Relieve Foot Pain
Custom-made insoles may help ease arthritic foot pain, according to researchers who conducted a review of 11 studies that included 1,332 people.
The Australian team concluded that custom foot orthoses -- insoles molded to a cast of the foot -- may reduce pain within three months in adults with rheumatoid arthritis and in children with juvenile idiopathic arthritis, United Press International reported.
Treatment with custom foot orthoses may also reduce pain in adults with highly-arched feet or prominent big toe joints, according to the review, which appears in the The Cochrane Library.
The review authors said custom orthoses were safe, but additional research is needed to better understand their effectiveness, UPI reported.
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