Hotspring 44
12-02-2010, 05:03 PM
<!--><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--><xml> <w:LatentStyles DefLockedState="false" LatentStyleCount="156"> </w:LatentStyles> </xml><![endif]--><!--[if gte mso 10]> <style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} table.MsoTableGrid {mso-style-name:"Table Grid"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; border:solid windowtext 1.0pt; mso-border-alt:solid windowtext .5pt; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-border-insideh:.5pt solid windowtext; mso-border-insidev:.5pt solid windowtext; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} </style> <![endif]--> Action Alert: Natural, Bioavailable Forms of B6 in Peril! (https://www.anh-usa.org/action-alert-natural-bioavailable-forms-of-b6-in-peril/)
November 23, 2010
Everyone says, “Take your vitamins.” If only they’d let us! Vitamin B6 is something of a miracle worker. The FDA bans one of the most bioavailable forms of it so a drug company can monopolize it. Now even the form of B-6 we can’t live without is at risk of being banned for the same reason—because a drug company wants it!
Pyridoxamine—one of only three natural and bioavailable forms of B6—inhibits aging and disease progression. It’s especially effective at inhibiting the formation of what are called Advanced Glycation End-products, or AGEs. This is a particularly appropriate abbreviation, since pyridoxamine’s target seems to be age-related problems like skin wrinkling, atherosclerosis, chronic inflammation, cataract formation, kidney failure, diabetic complications, and Alzheimer’s disease. [I]Life Extension magazine offered a marvelous explanation of how this unique form of B6 works in our bodies (https://www.lef.org/magazine/mag2008/oct2008_Vitamin-B6-Protects-Against-Diabetes-Aging_01.htm) to fight glycation and slow aging.
Unfortunately, FDA banned pyridoxamine in 2008 in response to a petition from a drug company that wanted to use it in their own drug formulation. This means our only access to pyridoxamine will be via the synthetic drug version. The ban on pyridoxamine as a supplement is a tremendous loss.
An alternative to pyridoxamine, and one that has similar anti-glycation properties, is one of the other forms of vitamin B6—a compound called pyridoxal-5′-phosphate, or P5P. It’s the only one that can be used directly by the body without conversion. While everyone needs B6 to live, some people have difficulty converting other forms of B6 to P5P, so the elimination of natural P5P could make them entirely dependent on drugs for survival.
(https://intelegen.com/nutrients/pyridoxal5phosphate.htm)
P5P lowers the body’s levels of homocysteine (https://intelegen.com/nutrients/pyridoxal5phosphate.htm), an amino acid that is a potential risk factor in cardiovascular disease. P5P also supports protein metabolism and muscle growth, and helps overcome premenstrual symptoms and depression by encouraging the production of the brain’s “feel-good” chemicals, serotonin and dopamine. New research has demonstrated that P5P may also protect against pancreatic cancer; other studies demonstrate that P5P protects against kidney disease and eye disease (https://www.lef.org/magazine/mag2009/jul2009_B6-Vitamers_01.htm).
P5P exists in food, and has been available as a supplement for years. But now even P5P is under threat! The FDA has a petition from Medicure Pharma (https://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2007-P-0410) to ban P5P. If the petition is approved, we will have to wait until we get sick to obtain a prescription for the drug. We’ll no longer be able to maintain optimal health and prevent aging and diseases like cancer by proactively keeping P5P at the optimal level. It would be a complete travesty if P5P disappears from the market like pyridoxamine.
We have asked you in the past to send a message to the FDA and Congress protesting Medicure’s attempt to grab P5P, and we need to keep the pressure on—the stakes are just too high. If you haven’t yet written to the FDA and Congress, please do so today. And if you have already sent your message, thank you—but if you don’t mind, please write again and continue to voice your objections. Don’t let the FDA take away our access to this natural miracle-worker. [I]Please take action now!
<table class="MsoTableGrid" style="border-collapse: collapse; border: medium none;" border="1" cellpadding="0" cellspacing="0"> <tbody><tr style=""> <td style="border: 1pt solid windowtext; padding: 0in 5.4pt;" valign="top">
TO SEND YOUR MESSAGE TO THE FDA AND CONGRESS
Click THIS LINK (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=334) to go to the Action Alert page. Once there, fill out the form with your name and address, etc., and customize your letter. We have a suggested message for you, but please feel free to add your own comments to the letter.
We’d also love to hear your comments about this article—just add your thoughts below—but remember that the messages below are only seen by our ANH-USA readers and not Congress, the FDA, etc.
</td> </tr> </tbody></table>
BTW, I also wrote to the White House, because somebody on the website suggested it is in essence, dysfunctional to write to the other representatives without also writing to the White House; (https://www.whitehouse.gov/contact/).
<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:LatentStyles DefLockedState="false" LatentStyleCount="156"> </w:LatentStyles> </xml><![endif]--><!--[if gte mso 10]> <style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} table.MsoTableGrid {mso-style-name:"Table Grid"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; border:solid windowtext 1.0pt; mso-border-alt:solid windowtext .5pt; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-border-insideh:.5pt solid windowtext; mso-border-insidev:.5pt solid windowtext; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} </style> <![endif]--><!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> </w:WordDocument> </xml><![endif]--><!--[if gte mso 9]><xml> <w:LatentStyles DefLockedState="false" LatentStyleCount="156"> </w:LatentStyles> </xml><![endif]--><!--[if gte mso 10]> <style> /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-parent:""; mso-padding-alt:0in 5.4pt 0in 5.4pt; mso-para-margin:0in; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:10.0pt; font-family:"Times New Roman"; mso-ansi-language:#0400; mso-fareast-language:#0400; mso-bidi-language:#0400;} </style> <![endif]-->"This letter is to voice my strong opposition to Medicure Pharma's so-called Citizen's Petition Request to Ban Pyridoxal 5'-Phosphate as a Dietary Supplement (FDA-2007P-0410).
I request that by the powers of the executive order, the president should order the FDA to reject this request, and having internal investigation of the Agency (FDA) and consider the possibility of replacing some of those (FDA) agents with others that would consider the American people. Instead of the profiteering, such as Medicure and others like it have been doing in regards to Americans right for use of essential food supplements to bolster our own individual health and wellness.
I also think that Congress should address this disturbing trend of drug companies seeking to convert widely available food and supplement items into monopoly prescription drugs.
However, considering that there are other major issues pressuring Congress at this point in time, Congress would not be able to enact anything swiftly enough to properly address this issue. That is why I believe the president should utilize the powers of the executive order at this point in time regarding FDA's decision on the matter.
Medicure has requested that the agency (FDA) ban the marketing of dietary supplements containing pyridoxal 5'-phosphate (P5P) because Medicure has a drug in development whose active ingredient is P5P. Medicure suggests that P5P is a new dietary ingredient, which is subject to pre-market approval requirements. However, within its own documents, Medicure admits that P5P is a naturally occurring molecule, a part of the Vitamin B6 family. P5P has in fact been a part of the human diet since the beginning of our species.
I do not see why Medicure's drug development should in any way restrict anybody's access to P5P as a food supplement.
Vitamin B6 is essential to good health. We would all die without it. Moreover our bodies must convert B6 into the P5P form in order to use it and not every human body does this efficiently. P5P should not be controlled by a drug company seeking to turn an essential part of our diet into a monopoly drug.
As an American who includes dietary supplements in my approach to health and wellness, I request that you place the rights of Americans ahead of the designs of industry and protect all Americans freedom to access dietary supplements.
Please at this point in time, require FDA to reject Medicure's so-called Citizen's Petition."
November 23, 2010
Everyone says, “Take your vitamins.” If only they’d let us! Vitamin B6 is something of a miracle worker. The FDA bans one of the most bioavailable forms of it so a drug company can monopolize it. Now even the form of B-6 we can’t live without is at risk of being banned for the same reason—because a drug company wants it!
Pyridoxamine—one of only three natural and bioavailable forms of B6—inhibits aging and disease progression. It’s especially effective at inhibiting the formation of what are called Advanced Glycation End-products, or AGEs. This is a particularly appropriate abbreviation, since pyridoxamine’s target seems to be age-related problems like skin wrinkling, atherosclerosis, chronic inflammation, cataract formation, kidney failure, diabetic complications, and Alzheimer’s disease. [I]Life Extension magazine offered a marvelous explanation of how this unique form of B6 works in our bodies (https://www.lef.org/magazine/mag2008/oct2008_Vitamin-B6-Protects-Against-Diabetes-Aging_01.htm) to fight glycation and slow aging.
Unfortunately, FDA banned pyridoxamine in 2008 in response to a petition from a drug company that wanted to use it in their own drug formulation. This means our only access to pyridoxamine will be via the synthetic drug version. The ban on pyridoxamine as a supplement is a tremendous loss.
An alternative to pyridoxamine, and one that has similar anti-glycation properties, is one of the other forms of vitamin B6—a compound called pyridoxal-5′-phosphate, or P5P. It’s the only one that can be used directly by the body without conversion. While everyone needs B6 to live, some people have difficulty converting other forms of B6 to P5P, so the elimination of natural P5P could make them entirely dependent on drugs for survival.
(https://intelegen.com/nutrients/pyridoxal5phosphate.htm)
P5P lowers the body’s levels of homocysteine (https://intelegen.com/nutrients/pyridoxal5phosphate.htm), an amino acid that is a potential risk factor in cardiovascular disease. P5P also supports protein metabolism and muscle growth, and helps overcome premenstrual symptoms and depression by encouraging the production of the brain’s “feel-good” chemicals, serotonin and dopamine. New research has demonstrated that P5P may also protect against pancreatic cancer; other studies demonstrate that P5P protects against kidney disease and eye disease (https://www.lef.org/magazine/mag2009/jul2009_B6-Vitamers_01.htm).
P5P exists in food, and has been available as a supplement for years. But now even P5P is under threat! The FDA has a petition from Medicure Pharma (https://www.regulations.gov/search/Regs/home.html#docketDetail?R=FDA-2007-P-0410) to ban P5P. If the petition is approved, we will have to wait until we get sick to obtain a prescription for the drug. We’ll no longer be able to maintain optimal health and prevent aging and diseases like cancer by proactively keeping P5P at the optimal level. It would be a complete travesty if P5P disappears from the market like pyridoxamine.
We have asked you in the past to send a message to the FDA and Congress protesting Medicure’s attempt to grab P5P, and we need to keep the pressure on—the stakes are just too high. If you haven’t yet written to the FDA and Congress, please do so today. And if you have already sent your message, thank you—but if you don’t mind, please write again and continue to voice your objections. Don’t let the FDA take away our access to this natural miracle-worker. [I]Please take action now!
<table class="MsoTableGrid" style="border-collapse: collapse; border: medium none;" border="1" cellpadding="0" cellspacing="0"> <tbody><tr style=""> <td style="border: 1pt solid windowtext; padding: 0in 5.4pt;" valign="top">
TO SEND YOUR MESSAGE TO THE FDA AND CONGRESS
Click THIS LINK (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=334) to go to the Action Alert page. Once there, fill out the form with your name and address, etc., and customize your letter. We have a suggested message for you, but please feel free to add your own comments to the letter.
We’d also love to hear your comments about this article—just add your thoughts below—but remember that the messages below are only seen by our ANH-USA readers and not Congress, the FDA, etc.
</td> </tr> </tbody></table>
BTW, I also wrote to the White House, because somebody on the website suggested it is in essence, dysfunctional to write to the other representatives without also writing to the White House; (https://www.whitehouse.gov/contact/).
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I request that by the powers of the executive order, the president should order the FDA to reject this request, and having internal investigation of the Agency (FDA) and consider the possibility of replacing some of those (FDA) agents with others that would consider the American people. Instead of the profiteering, such as Medicure and others like it have been doing in regards to Americans right for use of essential food supplements to bolster our own individual health and wellness.
I also think that Congress should address this disturbing trend of drug companies seeking to convert widely available food and supplement items into monopoly prescription drugs.
However, considering that there are other major issues pressuring Congress at this point in time, Congress would not be able to enact anything swiftly enough to properly address this issue. That is why I believe the president should utilize the powers of the executive order at this point in time regarding FDA's decision on the matter.
Medicure has requested that the agency (FDA) ban the marketing of dietary supplements containing pyridoxal 5'-phosphate (P5P) because Medicure has a drug in development whose active ingredient is P5P. Medicure suggests that P5P is a new dietary ingredient, which is subject to pre-market approval requirements. However, within its own documents, Medicure admits that P5P is a naturally occurring molecule, a part of the Vitamin B6 family. P5P has in fact been a part of the human diet since the beginning of our species.
I do not see why Medicure's drug development should in any way restrict anybody's access to P5P as a food supplement.
Vitamin B6 is essential to good health. We would all die without it. Moreover our bodies must convert B6 into the P5P form in order to use it and not every human body does this efficiently. P5P should not be controlled by a drug company seeking to turn an essential part of our diet into a monopoly drug.
As an American who includes dietary supplements in my approach to health and wellness, I request that you place the rights of Americans ahead of the designs of industry and protect all Americans freedom to access dietary supplements.
Please at this point in time, require FDA to reject Medicure's so-called Citizen's Petition."