Crazy FDA Ruling Allows Yet One More Lethal Drug on the Market

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March 21, 2006 | 4,829 views

An FDA advisory panel has unanimously recommended that the multiple sclerosis drug Tysabri be returned to the market.

The drug was withdrawn about a year ago after it was found to cause a deadly brain ailment.

It is expected that the FDA will follow the recommendation, making Tysabri the second instance ever of a drug returning to the market after being withdrawn for safety reasons.

Shares in Elan and Biogen, the manufacturers of the drug, jumped upward in response to the news.

About one in 1,000 people who took Tysabri during clinical trials developed progressive multifocal leukoencephalopathy (PML), a rare brain disease that results in death or severe disablement. There is no treatment for PML.

Tysabri is a monoclonal antibody that is given every four weeks by infusion into a vein. It is designed to interfere with movement of immune cells from the bloodstream, across the "blood-brain barrier," and into the brain and spinal cord.

Tysabri blocks this movement by attaching to alpha 4-integrin, a protein on the surface of immune T cells that normally enables them to pass through the blood-brain barrier.

I recently warned you about the FDA approving more testing on Tysabri, now it appears that it's coming back to market.

Although the FDA panel agreed Tysabri required mandatory controls to ensure patients were aware of all the risks, they also approved (by a 7-5 count) the drug as an initial therapy for MS, rather than only as a method of last resort.

This is especially problematic as the underlying principle that drugs are the solution for MS is flat out wrong. There is not one drug that treats the underlying cause of the disease. ALL of them are merely expensive, symptomatic and, in this case, potentially lethal, band-aids.

If you're looking for safer, healthier ways to treat MS without a lethal drug, I urge you to review my list of natural options. One of the smartest and most essential first steps to treating MS is to have your vitamin D blood levels checked and monitor them on a monthly basis (you want your level to be around 50).

However, our clinic has had a large number of patients with MS go into complete remission by following our raw food modifications of a diet appropriate for their nutritional type. I am constantly amazed at how effective nutritional typing is for MS.

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