Alert: Protect Your Right To Natural and Bio-available Vitamin B-6!
April 6, 2010
Human beings cannot live without vitamin B-6. It is also important for the prevention of cancer and the prevention and treatment of seizures, anemia, mental disorders including schizophrenia, carpal tunnel syndrome, and other conditions. Its effect on carpal tunnel can seem almost miraculous.
A natural form of the vitamin, Pyridoxamine, was recently yanked off the market by the FDA. Why? Because a pharmaceutical company, BioStratum, wanted sole use of pyridoxamine in a drug, a drug which may or may not ever appear. The company filed a so-called citizens petition and the FDA agreed, notwithstanding protests from ANH-USA, other organizations, and thousands of citizens. You might ask: how can Pharma take a supplement off the market and claim exclusive use of it as a prescription drug? The FDA does not presently feel obligated to answer this question.
Unfortunately, this isn’t all the bad news about vitamin B6. All forms of B-6, natural or synthetic, must be converted to P5P, another natural form, for the body to use it. Another drug company, Medicure Pharma, wants sole use of P5P and so has petitioned the FDA to ban its use as a supplement as well.
Medicure has yet to market a drug made from P5P, but wants the ban to take place now. And never mind that any individual unable to convert synthetic B6 to P5P would have to rely solely on Medicure’s product to stay alive.
How does Medicure think it can get away with this? Its petition states rather candidly: “Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs because many people may choose to purchase the supplements rather than the drugs.”
This is not of course a case of supplement producers creating a product to compete with an existing prescription drug. It is just the reverse. P5P, the natural and bioactive form of B6, has existed in food for as long as there have been humans and has been available as a supplement for years. Medicure seems to be saying: If it seems profitable, let’s just turn a critical vitamin, one essential for human life, into a drug, make it available only by prescription, and mark up the price. This is truly outrageous.
The FDA has not yet responded to Medicure’s petition. We have asked you in the past to send a message to the FDA and Congress protesting Medicure’s P5P grab, and the time has come to send some more messages. So if you haven’t sent in a message to the FDA and Congress yet, or even if you have, please send one today.
While we are discussing Vitamin B6, here is the latest scientific report. An analysis of 13 U.S., European and Asian studies of vitamin B6 and colon cancer, conducted from 2002-2009, has been published in a special edition of the Journal of the American Medical Association. Studies of the range of B6 doses found that vitamin B6 taken in higher doses reduced the risk of colon cancer by 21 percent. In one study, Dr. Susanna Larsson and her colleagues at Sweden’s National Institute of Environmental Medicine reported an inverse relationship between the intake of vitamin B6 or pyridoxine and the risk of colon cancer. Dr. Larsson linked the effect to bloodstream levels of pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6. Pyridoxal-phosphate is also known as pyridoxal 5-phosphate or (as we referred to it above) P5P.
Don’t let the FDA take away our access to the natural and most bioavailable form of B6, P5P. Please take action now.
Please protect my rights to Natural and Bio-available Vitamin B-6.
Thanks to those who are aware of what is going on and keeps us informed.
Corporate entities, especially those related to big Pharma, are dangerous entities that seem hell bent on controlling food and natural herbs, supplements and vitamins. They appear to want to dominate the food/medical industry. Any agenda like this is inherently suspect and worth opposing at all costs. The issue of “CONTROL” over vital elements in human health should be watched closely. Any and all attempt to monopolize them indicates an underlying attempt to weaken the ability of the consumer to make free choices and receive products that are potent enough to help (vitamins, etc.). This attempt to take over vitamins/supplements/herbs, to “criminalize” them in some instances, is absolutely frightening. People pushing it seem to regard those they’re pushing it on as cattle, or farm animals. We all know what terrible straights “Big Agra” has put our farm animals in. Greed/power cannot ever be a driving force with positive outcomes. OPPOSE this. Already our food supply is tainted; the nutrient values depleted. We practically eat “dust” and pay for advertising and gasoline to truck this non-food stuff to our dinner plates; stuff filled with chemicals to “hhok us” so we keep eating it, even desperately want it. Wake up!
Please leave our nutrients alone. Please leave our food alone. Please stop pandering to the drug companies by conceding to ridiculous claims that natural vitamins and minerals should come under the sole ownership and purview of the drug companies.
We would hope that you might, at some point, TRY to make us feel like you are doing what is in our best interests.
You would do your contacts a great service if you could have a congressional list to help readers properly send your imformation to their senators and represenatives. Those who are computer literate can probably do this quite easily but we who are not computer literate can’t do it without some help.
Please take action to keep natural supplements widely available to citizens. The FDA should rule against Medicure’s petition to have exclusive rights to P5P and Vitamin B6 — without which, human being would die! This is but an unacceptable P5P grab on Medicure’s part. Shame on you all.
Please don’t take away anymore of our right as US Citizens! Not even where the Vitamins are concerned.
Patricia Bright
I tried to leave a comment on the government site, but couldn’t find the document. Rats.
Thanks for putting this together.
The pharmaceutical companies are criminals. The “medicine” that they produce is all synthetic so the body cannot tolerate it. That’s why they have to make so many disclaimer, because they know
that it is poison and they need to protect themselves from lawsuits! The reason that they get away with that is, because they donate a lot of money to our crocked politicians!
Pharmaceuticals are our worst drugs, much worse than pot and opium. They can be fatal. They cause liver and kidney disease, blindness and stroke and are extremely addictive. They should be banned!!!!
The FDA is simply out of control. There is no apparent good reason for them to take away a beneficial, widely available, natural substance and give sole rights to a private company to “manufacture” it. What’s the old admonition? Follow the money!
I hope readers take this seriously–about 2 years ago there was a hearing.. on Pyridoxamine ..and it went in favor of the drug company. I then wrote to the FDA and was told that my comments would be put in the file, but to reverse this, it would take a massive number of folks opposing it. For those who a skeptical, folks this is real! ACT now!
I live in Great Britain and don’t know if my views make any differnence to your government, or if my emails will even be accepted. I do care since GB often follows USA in these things. besides, I care about America. If my emails can help please let me know and I will gladly send them. Thanks
Your petition against “Citizen Petition to Prohibit the marketing of dietary supplements containing Pyridoxal 5′-Phosphate” would be more effective if you made it clearer what to do when one follows your link to http://www.regulations.gov/... That turned out to be a morass that I could not navigate.
This is beyond outrageous. It’s also ironic that the same government who at times has said supplements are worthless and a rip off, are now willing to take them off the market not to protect it’s citizens but to profit with Big Pharma.
I’m going to rally as much support to reverse this as I can. Thank you for bringing the details to our attention.
What more are you intending to rob us of? Get a grip.
Come on people be real here.
Next you’ll be regulating the types of food allowed in our stomachs.
Stop this nonsense,
Louise Russell
After I finished writing to the various people you directed me to, I would have sent your info to more friends, but after sending the message to the first on my list, your page disappeared..
Dear Sylvia,
Thank you for pointing this out, we will look into how to improve this.
Kind regards,
ANH-USA
Our government needs to be thrown out and redone. The CFR runs the government and they buy or threaten anyone that opposes them. You can see how things work by the fact Obama got his health reform bill passed dispite what people wanted. WE either do something now or we are done and it will be a Big Brother government. The book 1984 isn’t far off from what we already have in play. Hopefully it isn’t too late already.
What do you mean by moderation??
the FDA (Fraud Development
Associates) gets millions of $$$$ from drug co’s for a new drug/approval. That FDA house needs a good cleaning out. When will SOMEBODY do something about this treachery?
Dear Folks: Just spent a very frustrating 20 minutes trying to get into the “Citizen Petition to Prohibit the marketing of dietary supplements containing Pyridoxal 5′-Phosphate” and just got shunted around in circles — just what anyone would expect from a government website — could not leave a comment. Am I surprised? Nope. Please advise.
Dear Lynn,
Thank you for pointing this out and bringing it to our attention. The regulations.gov site is not functioning properly, but we are capturing everyone’s comments and will send them directly to the FDA.
Thank you
ANH-USA
Hello,
No one should own the rights to vitamins. These vitamins help everyone and should not be just available for one company to have a monopoly.
Thank you,
Leave natural vitamins and minerals in the public domaine. I oppose allowing drug companies to control these products.
This parade of endless greed sickens me. These folks are on the same level of morality as AIG and Monsanto.
So what else is new? FDA removes another supplement from the market because a drug company is worried about their profits. Where is Congress, who is supposed to be representing the best interests of the public? I don’t know, I guess they are busy at work doing something, which is a mystery to me. Half the people don’t vote, I wonder why? I thought DSHEA was supposed to stop this type of nonsense. I’ll spread the word down at my local health food store.
This is completely outrageous!
Not only is it inexcusable and immoral corporate welfare, it places a hefty price tag on life itself. I strongly urge the FDA to not put a monopoly on this vital supplement in the hands of Big Pharma, but to ensure that supplements continue to be affordable and available over the counter.
I am very concerned that the FDA would allow our access to the natural and most bioavailable form of B6, P5P to be taken from us, the consumer. I ask that this not be allowed to happen! I ask that no pharmaceutical company should have total control of these products.
Pharmaceutical companiesa have NO BUSINESS asking the FDA to take away our access to B6. The general public has the right to use this vitamin as it needs to and sees fit to and not be limited to accessing it in the form of a prescription drug. The interference of the drug companies in the individual’s decision of using vitamins and other natural means to improve certain health issues is not right. I see it as just pure greed!! The FDA needs to exert much more care for the American people.
To whom it may concern,
You folks at the FDA need to leave natural vitamins, and vitamin supplements alone. Stop favoring the drug companies over the public’s God given rights just for the large profits they can make by taking these supplements of the market. Remember you work for us not the drug companies. Or do you?
Stop de FDA from taking away American’s rights to any and all forms of Vitamin B6. Every day, the rights of Americans are eroded more until we will have no freedoms left whatsoever. It is an outrage that greedy pharmaceutical companies are allowed by the FDA to take away Americans’ access to many substances we need for our health and which we can actually afford now, only to either suppress those substances or sell them for multiple times the current price once they’ve gotten their hands on them.
Constance P. Drescher
phuck the 100% corrupt and pharmacy owned fda.
We do not understand the instructions to send the 2nd email. Thank you.
Dear Martelle,
Thank you for pointing this out, this is an issue with the regulations.gov website. To rectify this we are capturing all the emails that are being sent and will print them out and send them to the FDA on your behalf. Thank you for taking the time to get involved.
ANH-USA
This is outrageous! Natural supplements in all forms MUST be left alone. The consumer is who the FDA is suppose to protect, not the drug companies. I choose to use natural harmless supplements which is why I have stayed healthy for years without drugs. This should be my choice. Enough! The drug companies have no business doing this and with the FDA’s approval, ENOUGH.
Suzanne Lovell
The link to regulations.gov for the docket is broken.
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 FDA reject this request and that the Agency and Congress address this disturbing trend of drug companies seeking to convert widely available food and supplement items into monopoly prescription drugs.
Medicure has requested that the agency 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 it’s 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 my 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 my freedom to access dietary supplements. Please reject Medicure’s so-called Citizen’s Petition.
A copy of this communication is being shared with my senators and representative.
I tried to send a comment to the FDA using this tool. I personalized the letter, pressed send, and then I got a message that my letter hadn’t actually gone to the FDA, and you gave me a link to go to Regulations.gov to make a comment. Except that once I’m at that site, I have no idea how to find the correct place to make a comment, and you have not provided the Docket number anywhere in this material. I have tried searching but to no avail. So you need to make this more functional, provide a direct link to the correct comment page, or if not give us the docket number. I’m VERY INTERESTED in helping but was unable to find where to make a comment. I can’t forward this request for support to my contacts until it’s working better. Thank you for all the work you are doing, it is much appreciated.
Dear Victoria,
Thank you for taking the time to point this out, we had an issue with the link to the regulations.gov website, but please be assured that we have captured your comments (a copy of every email is also sent to us) and we will be printing off the comments and sending them directly to the FDA.
Kind regards,
ANH-USA
1.
dr noah yamore’ says:
Your comment is awaiting moderation.
April 6, 2010 at 7:57 pm
KEEP OUR SUPPLEMENTS FREE TO PURCHASE W/O PRESCRIPTIONS
While we are discussing Vitamin B6, here is the latest scientific report. An analysis of 13 U.S., European and Asian studies of vitamin B6 and colon cancer, conducted from 2002-2009, has been published in a special edition of the Journal of the American Medical Association. Studies of the range of B6 doses found that vitamin B6 taken in higher doses reduced the risk of colon cancer by 21 percent. In one study, Dr. Susanna Larsson and her colleagues at Sweden’s National Institute of Environmental Medicine reported an inverse relationship between the intake of vitamin B6 or pyridoxine and the risk of colon cancer. Dr. Larsson linked the effect to bloodstream levels of pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6. Pyridoxal-phosphate is also known as pyridoxal 5-phosphate or (as we referred to it above) P5P.
FDA needs More REGULATION !!!!!!!
Reply
KEEP OUR SUPPLEMENTS FREE TO PURCHASE W/O PRESCRIPTIONS
While we are discussing Vitamin B6, here is the latest scientific report. An analysis of 13 U.S., European and Asian studies of vitamin B6 and colon cancer, conducted from 2002-2009, has been published in a special edition of the Journal of the American Medical Association. Studies of the range of B6 doses found that vitamin B6 taken in higher doses reduced the risk of colon cancer by 21 percent. In one study, Dr. Susanna Larsson and her colleagues at Sweden’s National Institute of Environmental Medicine reported an inverse relationship between the intake of vitamin B6 or pyridoxine and the risk of colon cancer. Dr. Larsson linked the effect to bloodstream levels of pyridoxal-phosphate (PLP), the main active coenzyme form of vitamin B6. Pyridoxal-phosphate is also known as pyridoxal 5-phosphate or (as we referred to it above) P5P.
FDA needs More REGULATION !!!!!!!
Do not let the FDA take away our precious natural supplements and turn them over to the greedy Big Pharmas; it is not necessary to turn our natural vitamins over to them so that they make them available by prescription only.
No, No, No!!!!!
The FDA needs to stay out of decisions regarding health care products such as vitamins B6 and P5P.
Also it should keep out of the consumers decisions to decide for themselves what is healthy for them and what is not. Keep vitamins within reach of the public at large. Prevent the FDA from making decisions to blocking vitamins and minerals.
Thank you, Bobbi Watkins
This a good example of the abuse of authority by the FDA and the unconscienable bill proposed by Sen. John McCain and supported by our 2 egually unconscienable Maryland Senators. Is there some way we can keep our senators from supporting FDA and the Pharmaceutical industry?
A natural form of the vitamin, Pyridoxamine, was recently yanked off the market by the FDA. Why? Because a pharmaceutical company, BioStratum, wanted sole use of pyridoxamine in a drug, a drug which may or may not ever appear. The company filed a so-called citizens petition and the FDA agreed, notwithstanding protests from ANH-USA, other organizations, and thousands of citizens. You might ask: how can Pharma take a supplement off the market and claim exclusive use of it as a prescription drug? The FDA does not presently feel obligated to answer this question.
I thoroughly disapprove of attempts to call vitamins “drugs.”
May such nonsense encounter the defeat it deserves.
Yours very truly,
Louise Esther Rothstein.
This is so ridiculous! I feel America should stand strong in front of the face of Corporate politics such as pharma to own all rights to natural things that work for our health. Americans should take health back and no leave it to big business to control…..
I MUST HAVE VITAMIN B6. I had a positive TB test though never contracted the disease itself. I am unable to ever be tested for TB again, and my PCP has told me to remain on Vitamin B6 – PERIOD. It is not right for it to be removed from my pharmacy and given to a drug company. I pay for enough pharmaceuticals to survive as is. I am on social security disability, so one supplement (I take others) will be given a higher price just because – WHY?
Keep your hands off my Vitamin B6!
Cindy Colwell
Indianapolis, IN
Outrageous and disgusting! Sadly, it’s just one more example of FDA shenanigans.
Follow the money…again and you’ll no doubt find it in some FDA pockets.
It’s hard to know where the Pharmaceutical companies end, and the FDA begins…
They’re pretty much joined at the hip…
Partners in trying to keep supplements out of the market!
Well, we’re gonna stop ‘em… again!
Thank you for keeping us informed.
Duane
Thank you for your excellent information. I am pleased to take the actions you suggest. However sometimes I find the instructions on taking the actions somewhat confusing, and I have left without taking the action. for instance on the vitamin B6 action I couldn’t figure out how to send my comment to the FDA, I think I sent it to congressmen.
this is another way to take away our right to choose…….
it seems Congress is always in favor of big business
and not our personal freedoms…….Congress is backwards
and should be protecting us but instead is selling us out…
Attn: FDA
Keep your — and the drug companies’ — hands off our vitamins and other natural and SAFE substances. Stop working FOR the drug companies and start doing your job – working FOR THE US PUBLIC!
this is another way of taking away our right to choose………
this is supposed to be a great country where people are allowed to have
personal freedoms..
but it seems that all the government wants to do is support big business
and take away our rights………
and just because Congress is made up of people who are the decision
makers does it really mean that they actually know anything?………
they don’t even know that feeding cows food that is unnatural to them is causing
the need for anti-biotics and then we have a problem with the fact that anti-biotics
are no longer working…….
i don’t think our Congress is very smart……..
Taking away our rights to natural vitamins and giving those right to pharmaceutical companies could be construed as blatant disregard for the lives you are being paid to protect. The people of America.
What does it mean “Your comment is awaiting moderation?”
Dear Karen,
We approve all comments that appear on our site. We post all comments that do not contain strong profanities.
Kind regards,
ANH-USA
Giving the rights to vitamins to pharmaceutical is blatant murder of the people you’re paid to protect.
Please fix this obvious typo so people can share this article and not lose credibility:”make it available only by subscription”