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Crohn's Disease treated with MS Drug?
Fish Oil Reduces Body Fat
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Crohn's Disease treated with MS multiple sclerosis Drug?
According to San Diego Union Tribune staff writer, Terri Somers, a federal advisory panel has suggested that Biogen Idec's and Elan's multiple sclerosis drug Tysabri should also be approved to treat Crohn's Disease. However, because of risks of dangerous side effects, the drug's use should be limited to patients for whom other therapies have failed.
The advisory panel's decision was a boost for the companies, after Food and Drug Administration staff members had previously filed a report questioning whether the risk of contracting a fatal nervous system disease from using Tysabri would outweigh it's benefits to Crohn's patients.
European regulators also said the drug's benefits didn't outweigh it's risks. But the FDA gastrointestinal drug and drug safety advisory committee voted 12-3 to recommend the drug for approval for people with moderate to severe Crohn's Disease, with the condition that the companies have strict post-marketing surveillance to monitor problems with side effects.
"The committee also required a strict risk-management program for Tysabri and for FDA to put clearly defined endpoints to protect patients, and to remove from the market if needed," the FDA said. The FDA is not bound to accept the advisory panel's recommendation, but often does.
The critical FDA staff report said clinical trial data submitted by the companies doesn't show that Tysabri works better than existing therapies for Crohn's Disease. Nor has it achieved the same level of effectiveness in treating Crohn's that it has in treating MS, the staff members concluded.
Tysabri use in MS has been restricted and closely monitored since it's return to the market in July 2006. The drug was pulled in February 2005, a few months after its market launch, after three patients developed a usually deadly disorder called progressive multifocal leukoencephalopathy, or PML.
Two of the three patients died; one of the dead was a 60-year-old man with Crohn's Disease who took part in a clinical trial to test the drug to treat the disease. PML is triggered by a virus that usually attacks people whose immune systems are severely impaired. The FDA let Tysabri back on the market under the condition that patients not use it in combination with drugs used to suppress the immune system.
In the critical FDA staff report, reviewers said it will be more difficult to assure the safety of Tysabri in Crohn's patients because they are more likely to take immune-system suppressing drugs as additional therapy.
Fish Oil Reduces Body Fat
Fish oil has been recognized for its benefit in cognitive function and protection against cardiovascular diseases. Now researchers from the University of South Australia found that fish oil has a positive effect on those who are overweight. Fish oil has shown an even greater result if used along with exercise. In addition to reducing body fat, this study that was published in the May issue of American Journal of Clinical Nutrition found that fish oil supplements improve cholesterol levels and blood vessel activity.
The researchers conducting the 12-week study arranged 75 overweight volunteers into 4 different groups at random. The individuals consumed either 6 grams of fish oil per day, consumed 6 grams of fish oil plus 45 minutes of exercise 3 times per week, took placebos (sunflower oil capsules) or combined the placebos with exercise.
The study found that those who used fish oil supplements made greater strides in the reduction of body fat than those who took the placebo. According to the findings, those who combined fish oil and exercise benefited the most - losses of 3.5 lbs. Although this is only the first experimental test of the effect of fish oil in collaboration with exercise, Peter R.C. Howe of the University of Australia believes "increasing intake of omega-3 fatty acids could be a useful adjunct to exercise programs aimed at improving body composition and decreasing cardiovascular disease risk."
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