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FDA Seeks to Ban Pyridoxamine

July 2009

By William Faloon

William Faloon 
William Faloon

In this month’s issue, you’ll read about scientific studies that confirm how glycation accelerates age-related disease. The faster our body’s proteins succumb to glycation reactions, the sooner we die.

Fortunately, several proven methods exist to slow toxic glycation processes. Nothing, however, completely stops glycation. The best we can do is to incorporate a wide range of anti-glycation strategies into our daily program as most members now do.

Glycation is the pathologic binding of glucose to proteins in our body. Proteins are the body’s primary structural component. Glycation causes our proteins to crosslink and become non-functional. These non-functional proteins are referred to as advanced glycation end products.1

Scientists have developed a method to break glycated protein crosslinks, thereby reversing this mechanism of aging. FDA regulatory barriers have impeded research into these crosslink breakers, also known as glycation-reversing agents.

Glycation also damages our body’s lipids. The outer membrane of our cells is made up of phospholipids, cholesterol, and proteins. Glycation damages tissues throughout the body by degrading the structure and function of our cell membranes.2,3 Since a membrane is the interface between the cell’s interior components (such as DNA and mitochondria) and the fluid surrounding the cell, maintaining these structures is critical to sustaining life.

The FDA wants to deny Americans access to one of the most effective ways to slow pathological glycation reactions in our aging bodies! Unless the FDA’s insidious ban of this natural vitamin B6 compound is stopped, Americans will age faster and suffer increased incidences of degenerative diseases.

FDA Seeks to Ban Pyridoxamine
The cell membrane is the outer barrier that contains and protects vital cellular structures such as DNA and mitochondria. Phospholipids and proteins in the cell membrane are highly vulnerable to toxic glycation reactions.

What Makes Pyridoxamine So Special?

Research supports the ability of pyridoxamine vitamin B6 to prevent chronic disease and inhibit disease progression. Pyridoxamine is particularly effective in inhibiting the formation of advanced glycation end products. Some of the age-related problems pyridoxamine may be effective against are:

  • Skin wrinkling4
  • Atherosclerosis5-7
  • Chronic inflammation8
  • Cataract formation9
  • Kidney failure7,10-12
  • Diabetic complications3,5,7,9,11,13-15
  • Alzheimer’s disease.16,17

Unlike pyridoxine (the standard form of B6), high doses of pyridoxamine can be taken without concern for peripheral neuropathy.18-20 Some have argued that pyridoxamine should be the only form of vitamin B6 used in supplements. That’s unlikely to occur as the FDA has said it will now ban pyridoxamine in response to a petition filed by pharmaceutical interests to make it available only as a prescription drug!21

The FDA’s Position

Kidney disease causes almost 500,000 Americans to require dialysis or a transplant.22 Diabetes is the leading cause of end-stage kidney disease.23 With today’s epidemic of type 2 diabetes, the market for a drug that protects against diabetic complications is huge.

The FDA’s Position

Based on scientific data documenting its remarkable biologic effects, a drug company paid for studies to prove the efficacy of pyridoxamine in protecting against diabetic complications.

One of these studies showed that pyridoxamine slowed the rate of rise of a marker of kidney failure (creatinine) by 68% and improved certain parameters of kidney function in humans.24 This company spent about $100 million funding various pyridoxamine studies before it ran out of money.25 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…”21

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!

When Might Pyridoxamine be Available as a Prescription Drug?
When Might Pyridoxamine be Available as a Prescription Drug?

Even under the FDA’s fast track program, obtaining new drug approval can take decades.

In the case of pyridoxamine, which has been around since life evolved on earth, there are numerous hurdles that have to be cleared before it becomes an official “drug.”

Assuming successful completion of a Phase IIb trial—this assumes an end-of-Phase II meeting and formal vetting of Phase III (pivotal, registrational) trial design(s) and associated study endpoints—and assuming at least two Phase III trials involving 1,500 patients studied for at least six months (and at least 500 patients studied for at least one year, and at least 200 studied for two years), with estimates for Phase III trial recruiting of 12 months and a nine-month turnaround time from the FDA following NDA (new drug application) submission, an estimated timeline would suggest that pyridoxamine might be available around 2014.

Until these clinical trials are completed, an outside FDA review committee recommends approval, and FDA bureaucrats grant approval, pyridoxamine will never be available to American citizens. The death toll from heart attack, kidney failure, and a host of other diseases preventable with pyridoxamine may then reach into the millions.27

The FDA pretends to “protect the public health.” This cruel hoax is once again exposed by this bureaucratic edict that seeks to deny Americans access to a critically important disease-fighting nutrient.

Pyridoxamine is Found Naturally in Our Food!

Pyridoxamine occurs naturally in fish, chicken, walnuts, carrots, eggs, and other foods. People ingest small quantities each day. The FDA apparently feels so empowered that it thinks it can by proclamation ban an ingredient people obtain in their normal diet.

By defining the safest form of vitamin B6 (pyridoxamine) to be a “new drug,” the FDA has once again capitulated to pharmaceutical financial interests at the expense of the public’s health.

What if Pyridoxamine is Approved as a Drug?

On March 25, 2008, the company seeking to have pyridoxamine approved as a “drug” stated that it will be conducting a Phase IIb study on diabetic patients with kidney disease. The estimated study completion date is August 2010.26

What if Pyridoxamine is Approved as a Drug?

If this study demonstrates a successful clinical outcome, it will then be submitted to the FDA for so-called “fast track” approval. It could take several years, if ever, before FDA approval is granted for pyridoxamine. In the meantime, according to the FDA’s Byzantine logic, no American is “allowed” to have pyridoxamine, effectively condemn-ing millions to needless suffering and death.

If pyridoxamine is ever approved, it will only be for very limited indications, such as end-stage kidney failure and diabetic neuropathies. Unless you happen to suffer from these diseases, you will find it difficult to obtain a “pyridoxamine prescription.” Then again, the cost of “prescription pyridoxamine” will be so astronomical that few will be able to afford it anyway.

If pyridoxamine becomes a new drug, the federal government will spend millions of tax dollars paying full retail price for it via the corrupt Medicare Prescription Drug Act, which adds another absurdity to the FDA’s proposed ban.

The Silent Kidney Disease Epidemic

More than 26 million Americans over age 20 suffer chronic kidney disease, which represents 13% of the adult population!22

Diabetes and poorly controlled blood pressure are the leading causes of kidney failure, meaning this epidemic is largely preventable with early detection.28 Annual blood chemistry tests and regular blood pressure checks can identify deteriorating kidney function early and enable one to initiate corrective actions. Fortunately, most Life Extension members have their blood tested to monitor kidney filtration levels and glucose control.

Unfortunately, millions of Americans do not have regular blood tests (or blood pressure checks), resulting in the silent development of end-stage renal disease. For too many victims, they don’t find out their kidneys have failed until admitted to a hospital emergency room with severe symptoms.

End-stage renal disease is the name for kidney failure so advanced that it cannot be reversed. End-stage renal disease means that kidney function is so poor that the patient cannot be kept alive without aggressive and often only partially effective treatment.

There are 336,000 Americans receiving chronic dialysis treatment right now.22 Another 136,000 Americans are surviving with a kidney transplant.22 These treatments can induce serous side effects that shorten the patient’s life span. The annual cost of dialysis alone is about $70,000, most of which is borne by Medicare (which is facing near-term insolvency).29

The National Kidney Foundation estimates that more than 67,000 Americans die of kidney failure each year,22 but this is an understated statistic. That’s because kidney failure often causes death from heart attack,30 stroke,30 or osteoporosis.31,32 Doctors signing death certificates often omit kidney disease as an underlying cause of fatal disease in their patients.33

Kidney failure is so devastating to aging individuals because it causes startlingly high levels of homocysteine31 and C-reactive protein,34 greater incidences of anemia,35,36 and a host of other complications.

The FDA is seeking to ban pyridoxamine, which has been demonstrated to significantly delay the progression of kidney disease.11-13

Pyridoxamine has been shown to slow the elevation of creatinine, a blood marker of kidney function by 68%.24 These data indicate that many of those destined to perish from kidney disease will be dying prematurely because of the FDA’s draconian actions to keep pyridoxamine away from the public.