Big Pharma Turns Vitamin B into a Controlled Drug

A natural form of the vitamin was recently yanked off the market by the FDA because a pharmaceutical company, BioStratum, wanted it's sole use in a drug.

Human beings cannot live without vitamin B-6. It is also important for the prevention of cancer and the prevention and treatment of seizures, anemia, mental disorders including schizophrenia, carpal tunnel syndrome, and other conditions. Its effect on carpal tunnel can seem almost miraculous.

A natural form of the vitamin, Pyridoxamine, was recently yanked off the market by the FDA. Why? Because a pharmaceutical company, BioStratum, wanted sole use of pyridoxamine in a drug, a drug which may or may not ever appear. The company filed a so-called citizens petition and the FDA agreed, notwithstanding protests from ANH-USA, other organizations, and thousands of citizens. You might ask: how can Pharma take a supplement off the market and claim exclusive use of it as a prescription drug? The FDA does not presently feel obligated to answer this question.

Unfortunately, this isn’t all the bad news about vitamin B6. All forms of B-6, natural or synthetic, must be converted to P5P, another natural form, for the body to use it. Another drug company, Medicure Pharma, wants sole use of P5P and so has petitioned the FDA to ban its use as a supplement as well.

Medicure has yet to market a drug made from P5P, but wants the ban to take place now. And never mind that any individual unable to convert synthetic B6 to P5P would have to rely solely on Medicure’s product to stay alive.

How does Medicure think it can get away with this? Its petition states rather candidly: “Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs because many people may choose to purchase the supplements rather than the drugs.”

This is not of course a case of supplement producers creating a product to compete with an existing prescription drug. It is just the reverse. P5P, the natural and bioactive form of B6, has existed in food for as long as there have been humans and has been available as a supplement for years. Medicure seems to be saying: If it seems profitable, let’s just turn a critical vitamin, one essential for human life, into a drug, make it available only by prescription, and mark up the price. This is truly outrageous.

The FDA has not yet responded to Medicure’s petition. We have asked you in the past to send a message to the FDA and Congress protesting Medicure’s P5P grab, and the time has come to send some more messages. So if you haven’t sent in a message to the FDA and Congress yet, or even if you have, please send one today.

While we are discussing Vitamin B6, here is the latest scientific report. An analysis of 13 U.S., European and Asian studies of vitamin B6 and colon cancer, conducted from 2002-2009, has been published in a special edition of the Journal of the American Medical Association. Studies of the range of B6 doses found that vitamin B6 taken in higher doses reduced the risk of colon cancer by 21 percent. In one study, Dr. Susanna Larsson and her colleagues at Sweden’s National Institute of Environmental Medicine reported an inverse relationship between the intake of vitamin B6 or pyridoxine and the risk of colon cancer. Dr. Larsson linked the effect to bloodstream levels of pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6. Pyridoxal-phosphate is also known as pyridoxal 5-phosphate or (as we referred to it above) P5P.

Don’t let the FDA take away our access to the natural and most bioavailable form of B6, P5P. Please take action now.

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