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Jun 11 09 3:54 PM
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Now, here is a "pro-Health" conspiracy that has my support:
Lloyd Miller, Research Director A-albionic ResearchA-albionic Research Inventory Liquidation Sale
Jun 11 09 6:13 PM
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
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:
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
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.
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!
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 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.
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
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
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.
More than 26 million Americans over age 20 suffer chronic kidney disease, which represents 13% of the adult
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
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.
Jun 11 09 10:57 PM
Pyridoxamine is one of the compounds composing vitamin B6, along
with pyridoxal and pyridoxine. Pyridoxamine is converted to the biologically active form, pyridoxal 5-phosphate, and inhibits formation of advanced glycation endproducts.
Pyridoxamine is based on a pyridine ring, with hydroxyl, methyl,
aminomethyl, and hydroxymethyl substituents. It differs from pyridoxine by the subsitituent at the 4-position.
Pyridoxamine is used as a dietary supplement, often as the hydrochloride
salt, pyridoxamine dihydrochloride. However, in the United States, the
FDA ruled in January 2009 that pyridoxamine must be regulated as a pharmaceutical drug because it is the active ingredient in Pyridorin, a drug designed to
prevent the progression of diabetic nephropathy. Consequently,
pyridoxamine can no longer be marketed in the United States as a dietary supplement.
Jun 11 09 11:02 PM
The Food and Drug Administration's (FDA) has ruled that the vitamin B6 compound
© NUTRAINGREDIENTS-USA.com - 02/02/2009
The Food and Drug Administration's (FDA) has ruled that the vitamin B6 compound, pyridoxamine dihydrochloride, cannot be used in
The decision, in response to a petition from a North Carolina-based firm called Biostratum, provoked the Washington DC-based Council for Responsible
Nutrition (CRN) to issue a statement warning that a precedent could be established that could see the status of other ingredients challenged.
Biostratum and CRN have been debating the status of the ingredient via FDA petitions since at July, 2005. Biostratum is the manufacturer of a
pyridoxamine-based drug called Pyridorin designed to prevent the progression of diabetic nephropathy (kidney disease).
The FDA verdict, delieved on January 12, reasoned that the ingredient was authorized for investigation as a new drug before it was ever marketed as a
dietary supplement. Such situations forbid dietary supplement marketing, a fact CRN accepts, but the group said in a statement it was
"disappointed" with the decision nonetheless.
The trade group said the case highlighted an ongoing area of uncertainty that contributed to the status of pyridoxamine dihydrochloride being altered.
There exists a grandfathering clause for ingredients that have been on the market for more than 15 years, but CRN said the way this list functioned
"was not agreed upon".
This 15-year period coincides with the enactment of the 1994 Dietary Supplements and Health Education Act (DSHEA), around which time much evidence was
presented supporting ingredients such as pyridoxamine dihydrochloride.
"We are disappointed with FDA's response to the recent citizen petition involving pyridoxamine that apparently views as inadequate the evidence
presented by the industry, including CRN, of the previous marketing of pyridoxamine, even prior to the passage of DSHEA," said CRN vice president of
scientific and regulatory affairs, Andrew Shao PhD.
"FDA's decision suggests that companies need to produce even more extensive evidence supporting an ingredient's marketing as a dietary
supplement, including catalog and business records from more than 15 years ago."
Companies had to ensure that they could "substantiate that an ingredient has in fact previously been marketed as a dietary
In a previous letter to the FDA, dated September 14, 2005, the CRN's senior vice president of scientific and international affairs, John Hathcock, wrote
"Pyridoxamine is unequivocally a dietary ingredient because it is one of the three primary natural forms of vitamin B6, and it is one of the two
predominant forms in animal products used as human foods."
He noted pyridoxamine was on a CRN "gold list" of grandfathered ingredients that its marketing as a dietary ingredient was
"entirely consistent with the long history of the science of this form of vitamin B6."
At the time it said it would "gladly provide documentation of this fact".
Among other things, pyridoxamine inhibits the formation of advanced glycation deposits.
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