The company that makes a multiple sclerosis drug linked to an often-fatal brain disease will be asking U.S. regulators to allow the drug back on the market with additional warning labels.
Biogen Idec Inc.'s CEO, James Mullen, said in an interview with the Associated Press that the Cammbridge, Mass., company will recommend that the drug, Tysabri, include warnings about three cases of progressive multifocal leukoencephalopathy (PML), that were confirmed after clinical trials. Tysabri was withdrawn from the market on Feb. 28, three months after receiving U.S. Food and Drug Administration approval and despite hopes that it would become an important new tool in treating MS.
Mullen said the revised label that the company will propose to the FDA also will warn about risks for patients who have weak immune systems, and therefore could be more susceptible to contracting the disease.
However, Mullen added that the label language his company will suggest will acknowledge that scientists don't understand precisely how the bioengineered drug put the three patients who contracted PML at risk of contracting the rare disease, the AP reported. Two of those patients died.
Mullen said Biogen Idec and its Irish partner on Tysabri, Elan Corp., plan to submit findings from their review of the drug's safety to the FDA by the end of September.
After reviewing one year of data from planned two-year trials, federal regulators in November had approved Tysabri for sale to the 350,000 American sufferers of MS, a debilitating and incurable disease in which the body's immune system turns rebellious, attacking, inflaming and damaging its own nerve tissue.
FDA Official Resigns Over Plan B Delay
The director of the U.S. Food and Drug Administration's Office of Women's Health resigned Wednesday to protest the agency's delay in allowing over-the-counter sales of emergency contraception.
Susan Wood, who was also assistant commissioner for women's health, announced her resignation in an e-mail to colleagues at the agency, which was then forwarded by a number of organizations to media outlets.
The FDA on Friday announced that it was delaying for 60 days its long-awaited decision on whether to allow over-the-counter sales of the Plan B contraceptive pill. Plan B, often called the "morning-after" pill, can lower the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex.
In delaying its decision, which was contrary to the advice of its own scientific advisers, the FDA said it was comfortable allowing over-the-counter sales to adults 18 and older, but wanted more time to decide how to keep it out of the hands of young teenagers.
In her resignation, Wood said, "I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled."
She added, "The recent decision announced by the Commissioner about emergency contraception, which continues to limit women's access to a product that would reduce unintended pregnancies and reduce abortions, is contrary to my core commitment to improving and advancing women's health."
Plan B's maker has been trying for two years to begin nonprescription sales, and the FDA's latest postponement of its fate was a surprise: Commissioner Lester Crawford won Senate confirmation to take his job only after promising members of Congress to make a final decision by Sept. 1, the Associated Press reported.
The Society for Women's Health Research issued a statement calling Wood's resignation, "a severe loss to the advancement of women's health."
"When the director of the office that 'serves as a champion for women's health' is not involved in decisions critical to women's health, the immediate consequences for America's women are tremendous," the statement added.
New Treatment Approved for Short Children
The U.S. Food and Drug Administration on Wednesday approved the Tercica drug Increlex to treat children of short stature whose bodies don't properly process growth hormone.
An estimated 6,000 children in the United States have a severe form of a condition in which they produce antibodies that neutralize growth hormone. These children are not growth-hormone deficient and therefore aren't likely to respond to standard growth hormone replacement therapy, Tercica said in a statement.
Children with severe IGF-1 deficiency lack a body chemical called insulin-like growth factor-1, which is needed for the normal growth of bones, cartilage and organs, said Tercica, a Brisbane, Calif., biotech company.
No Cell Phone Link to Cancer, U.K. Researchers Say
Using a cell phone even for 10 years does not increase the risk of brain cancer, U.K. researchers report.
The scientists, who conducted the largest study so far on the subject, said they could not rule out a higher risk over a longer period, however, the Independent reported.
"The results of our study suggest there is no substantial risk in the first decade after starting use," said Anthony Swerdlow, of the Institute of Cancer Research in London. "Whether there are longer-term risks remains unknown, reflecting the fact that this is a relatively recent technology."
The research, published in the British Journal of Cancer, focused on the risk of acoustic neuroma, benign tumors that grow in the nerve connecting the ear and inner ear to the brain, close to where handsets are held.
The institute's analysis pooled studies conducted in Britain, Denmark, Finland, Norway and Sweden, all countries where cell phones were introduced early.
Food Fact: Culture club.
When yogurt's live active cultures colonize your digestive system, they draw a line in the sand against disease. The cultures -- especially acidophilus and bifida - muscle out potentially threatening bacteria. Low-fat or fat-free yogurt has a lot of other things going for it: It's easy to digest, especially for those who are lactose-intolerant and have difficulty digesting milk and many cheeses; it's an excellent source of calcium, protein, riboflavin (a B vitamin), vitamin B-12 (which may be low in vegetarian diets) and vitamin A; and provides selenium, potassium and magnesium.
Fitness Tip of the day: Want strong bones?
All it takes is 20 minutes of the right weight-bearing exercise three days per week. Activity such as walking will stimulate bone growth and prevent bone loss throughout life. Strength training, such as weight lifting, fortifies bone and can reduce your risk of developing osteoporosis.
FAQ of the day: Can certain foods prevent cancer?
No one can say with absolute certainty how powerful is diet in preventing cancer. But at least a third (and possibly more) of all cancers have been linked to diet. People who eat the most fruits and vegetables have been shown to have about half the risk of developing cancer as people who rarely eat them. Your genes and other lifestyle factors, such as smoking, have a strong say in your susceptibility to cancer. But it's likely that improving the typical American diet would make a big dent in new cases of cancer, the nation's second biggest killer after heart disease.