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Pyridoxamine is one form of the vitamin B6. It is an important nutrient for helping your body process carbohydrates, support your nervous system activity and prevent homocysteine, which has been linked to increased risk of heart disease, from building up in your blood.

This substance has long been sold over-the-counter as a dietary supplement, but the FDA abruptly put a stop to that in January 2009. Their reasoning has nothing to do with safety, but rather is firmly based on protecting a drug company’s investment.

As stated above, the FDA actually said:

“To allow such an article to be marketed as a dietary supplement would not be fair to the pharmaceutical company that brought, or intends to bring, the drug to market.”

What is happening here is a blatant example of the FDA protecting the hand that feeds it. It is now essentially banning vitamin B6 in the form of pyridoxamine, and reserving it to be exclusively distributed by the drugmaker Biostratum, Inc

By replacing the -CH2OH group on position 4 of the pyridoxine molecule with -CH2NH2 and -CHO respectively, two related compounds, pyridoxamine and pyridoxal can be formed which are also vitamin active.

Data submitted to us by Dr. E. E. Snell showed that various procedures
involving amination or oxidation of pyridoxine resulted in substances which
had much greater activity than pyridoxine itself toward certain lactic acid
bacteria.

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Almost two years after producing encouraging phase II results, Pyridorin, a capsule with a white powder inside, remains fatherless, with no commercial parent willing to take on the risk of funding an expensive phase III trial.

"There have been some questions regarding the (intellectual property)," says Steiner.

In early clinical trials, the drug was found to be effective. In a phase II trial on 224 patients, Pyridorin was shown to "slow the progression of diabetic neuropathy," the company says in a filing with regulators. Pyridorin was also granted "fast track" status by the U.S. Food and Drug Administration.

INGREDIENT ON THE INTERNET
Whether Pyridorin ever gets to market could depend on how regulators rule on BioStratum's request to stop what it calls sales of "adulterated" pyridoxamine, the active ingredient in Pyridorin.

The problem for BioStratum is that many outfits, often operating with nothing more than a Web site, are marketing pyridoxamine as a nutrition supplement.

Pyridoxamine is synthesized from vitamin B6, which humans derive from eggs, chicken, carrots, fish and walnuts.

Intellectual property law does not allow BioStratum to own patents on pyridoxamine, but the company has a pending patent application on its method of obtaining pyridoxamine from vitamin B6.

Steiner says BioStratum officials wrote individually to companies that were selling the supplements, asking that they halt sales. The targeted companies agreed, Steiner says.

Fearful that other competitors would pop up in the future, BioStratum filed a "citizen petition" in July with the FDA seeking to disallow such sales. It claimed:

Pyridoxamine was not sold as a drug supplement prior to the enactment of the Dietary Supplement Health and Education Act of 1994 and hence was not "grandfathered" in as a dietary supplement.
Internet sales began after July 1999 when BioStratum submitted an "investigational new drug" filing for Pyridorin, and once a substance is part of a clinical trial it cannot be sold as a nutritional supplement, the company believes. "In our mind this is very clear," says Steiner. "Before clinical trials, this substance was not sold ... (so) in the U.S. it is illegal."
The dietary supplement industry is fighting back.

On Sept. 14, the Council for Responsible Nutrition, a Washington, D.C.-based trade association, challenged BioStratum's petition with the FDA, saying it has proof that pyridoxamine was sold for years prior to 1994.

"If this went to court, somebody would trot out some (sales) order," says John Hathcock, a vice president of scientific and international affairs at CRN. "We firmly believe such evidence exists."

Any claim that pyridoxamine is not a dietary supplement will be "laughed at," says Hathcock.

"Under U.S. regulations, it's absolutely permissible for an ingredient to be incorporated as a dietary supplement and sold as a drug," says Hathcock.

The FDA is yet to rule on BioStratum's petition.

DRUG HAS BIG MARKET
The regulatory tussle does not mean Pyridorin is stalled.

If the company can find a partner to fund phase III trials, which could cost as much as $85 million and take another five years, BioStratum could obtain approval for its drug specifically to treat diabetic kidney disease, in which case it would enjoy exclusive rights. Steiner says the company is in discussions with a number of potential commercial partners and could sign a deal soon.

By BioStratum's estimate, about 3.65 million people in the U.S. suffer from diabetic kidney disease every year. At a cost of about $1,200 a year per patient, Pyridorin is targeting a $4.4 billion market in the U.S. alone.

They would argue that it is all about them needing such exclusive rights to pay for the research logic being that if they do not get this money they can't pay for the research and therefore these things will remain unproven for the purpose. We'll all suffer in this story they say

however this is a good argument for why the companies should not be doing the research themselves. If we had publicly funded research and the companies after the fact would bid for the right to be the manufacturer, the public at large and to the extent the government buys drugs the government itself, would benefit by the lower cost that could be demanded.

The Myelin Repair Foundation (MRF) was created to address the systemic problems in medical research and commercial drug development that work against the rapid delivery of patient treatments. The MRF’s Accelerated Research Collaboration™ (ARC™) model is a radical new process that recognizes the incentives and limitations of academic scientists, commercial biopharma, government regulators, and patients and their families, and fosters behavioral changes by adding tangible value to everyone. As a not-for profit organization, the Myelin Repair Foundation is uniquely positioned to serve as an intermediary among these players with the rapid delivery of patient treatments as its singular focus

Many believe Myelin Repair Foundation’s ARC model has the potential to change the way all medical research is conducted, In fact, more than 60 different disease research organizations have contacted us to learn about how the model might be used to leverage their own investments in research.

"One of these studies showed that pryidoxamine slowed the rate of rise of a marker of kidney failure (creatinine) by 68% and improved certain parameters of kidney function in humans. This company spent about $100 million funding various pyridoxamine studies before it ran out of money. The FDA wants to protect pharmaceutical financial interests, even if pyridoxamine is never approved as a new drug. According to the FDA, pyridoxamine cannot be marketed as a dietary supplement because:

"pyridoxamine is authorized for investigation as a new drug for which substantial clinical investigations have been conducted and their existence made public..."

The FDA's twisted position is that if vitamin companies can offer low-cost pyridoxamine supplements, then there is no incentive for a drug company to invest hundreds of millions of dollars getting it approved as a prescription drug. Said differently, to protect the financial interests of a pharmaceutical company, the FDA is willing to deny every health-conscious American access to the life-saving benefits of pyridoxamine, which include preventing the very disease the drug company is seeking to have pyridoxamine approved to treat!....

Drug companies have a strong economic bias for denying you access to pyridoxamine...

The FDA believes that allowing a drug that is being clinically tested to also be sold as a dietary supplement will prevent pharmaceutical companies from funding research. This is a FALSE assumption.

Each year, more than $400 million of an expensive drug called Niaspan is sold for the purpose of increasing beneficial HDL and reducing artery-clogging triglycerides (and LDL). Niaspan is nothing more than extended-release niacin that one can purchase as a low cost supplement.
While extended release niacin has long been available as a supplement, the most money is being made by pharmaceutical interests by virtue of mainstream doctors prescribing Niaspan to their cardiac patients and Medicare/insurance companies paying its inflated price.

Another dietary supplement that went through pharmaceutical funded clinical trials to prove its efficacy is the prescription fish oil drug called Lovaza (previously named Omacor). Even though Lovaza costs about seven times more than the same amount of EPA/DHA obtainable from dietary supplements, sales are exploding because many doctors are prescribing this fish oild drug to their cardiac patients. In 2007, pharmaceutical giant GlaxoSmithKline bought the maker of Lovaza for an astounding $1.65 billion. Glazo paid this astronomical amount of money for the ownership of this prescription fish oil knowing full well that dietary supplement fish oil could be obtained at a fraction of the price...

WHAT YOU CAN DO TO FIGHT BACK!
We know that pyridoxamine was used as a dietary supplement in the early 1990s. If we can prove that pyridoxamine was sold in the United States prior to 1994, the FDA will not be allowed to ban it. The Dietary Supplement Health and Education Act protects supplements marketed prior to October 1994.
If you used pyridoxamine prior to October 1994, please let us know so we can add your name to an affidavit and use any evidence you have to overturn the FDAs proposed ban on pyridoxamine. The FDA is controlled by the Executive branch of government. Writing to members of Congress may not work since they do not directly control arbitrary FDA decisions, such as banning of pyridoxamine at the bureaucratic level.
The White House, on the other hand, can with one phone call, demand that the FDA reverse its position and allow the free sale of pyridoxamine as a dietary supplement.
We therefore urge Life Extension (thisisms) members to mail the form letter that appears below to the health administrative affairs officer at the White House and demand that the FDA lift its proposed ban on pyridoxamine.


Nancy-Ann DeParle
Director
Office of Health Reform
The White House
1600 Pennsylvania Avenue NW
Washington, DC 20500


Dear Ms. DeParle,

The FDA is denying Americans access to a low-cost dietary supplement (pyridoxamine) in order to make this natural vitamin an expensive prescription drug.

If the FDA succeeds, the American public's health will be severely injured, and Medicare will be forced to fork over millions of unnecessary dollars to subsidize pyridoxamine as an overpriced pharmaceutical.

Safety is NOT the issue. The FDA admits its plan to ban pyridoxamine is in direct response to a petition filed by a pharmaceutical company. This company wants the FDA to grant it exclusive status to sell the safest form of vitamin B6 (pyridoxamine) as a drug!

At stake are the lives of millions of Americans whose health can be protected against a host of age-related diseases if pyridoxamine can be freely added to dietary supplement formulas.

The FDA has received a petition from another pharmaceutical company seeking to ban the sale of pyridoxal-5'-phosphate, which is another form of vitamin B6 that has been safely sold as a dietary supplement for decades. I ask that you instruct the FDA to reject this petition since pyridoxal-5'-phosphate provides numerous health benefits that cannot be obtained with conventional vitamin B6 (pyridoxine HC1) supplements.

I also ask that you mandate the FDA to reverse its inappropriate ban against pyridoxamine, so that it can once again be freely sold as a vitamin B6 dietary supplement.

Your administration has prioritized the need to make healthcare affordable to all. One simple way of accomplishing this is to not allow pharmaceutical companies to enjoy bureaucracy-bestowed monopolies.

Yours sincerely

Name:

Address: