The FDA's latest and classiest example of collusion with pharmaceutical interests is its attempt to ban pyridoxamine, a form of vitamin B6 that has been used as a cheap supplement for years. This particular vitamin has shown very good protection for kidney disease markers as per the discussion below which is takenfrom the latest Life Extension magazine.
"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 oil drug to their cardiac patients. In 2007, pharmaceutical giant GlaxoSmithKline bought the maker of Lovaza for an astounding $1.65 billion. Glaxo 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.
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.
3 years antibiotics, 06/09 bilateral jug stents at C1, 05/11 ballooning of both jug valves, 07/12 stenting of renal vein, azygos & jug valve ballooning,