NeuroTalk Support Groups - Big Pharma trying to get P-5-P off OTC

NeuroTalk Support Groups (https://www.neurotalk.org/)

- Vitamins, Nutrients, Herbs and Supplements (https://www.neurotalk.org/vitamins-nutrients-herbs-and-supplements/)

- - Big Pharma trying to get P-5-P off OTC (https://www.neurotalk.org/vitamins-nutrients-herbs-and-supplements/67699-pharma-trying-5-otc.html)

Big Pharma trying to get P-5-P off OTC

Well... Big Pharma strikes again!

Anyone here using P-5-P, I'd stock up now:

http://www.knowthelies.com/?q=node/2153

Quote:

Medicure Pharma, Inc., has been studying the clinical effects of Vitamin B6 (which they call "MC-1") on humans. This is part of a process for receiving FDA approval on MC-1 as a "drug," and then marketing this drug through the conventional medical system (and selling it at markups that can reach 500,000% over the cost of the actual ingredients).

and also this: The petition by Medicure to the FDA in April 08:
http://www.fdalawblog.net/fda_law_bl...n-petitio.html

I've been using this for over a decade! What a bummer new development!

blech!:mad:

P-5-P is an essential component in my son's health maintenance . Combined with his magensium and Inositol it helps his TS tics and OCD greatly. We use the one by NOW foods

Not liking this!:mad:
Is it just P5P ?
This would not include all B6, right?
I have told EVERYONE about how my B50 tablets, some additional B12 has been VERY helpful for me.

where do we write to object??

http://www.regulations.gov/fdmspubli...0000648051908f

there is a little yellow balloon in the text of the petition, and you click on it and
then you can reply.
"add comments" and is 6 lines down.

I just sent this letter to them

via the comments section:

Quote:

I have to protest this petition vehemently. I have been using P-5-P for over a decade myself, and also I am aware of people who do very well on it, with absolutely no side effects. The people in US who have pyroluria (confirmed by testing) are dependent on P-5-P to minimize their symptoms. Some people cannot convert pyridoxine to P5P in vivo because of of pyridoxal kinase errors either genetic or drug induced.

It is basically criminal to withhold nutrients from the public who desperately need them.
Merck tried to control methylfolate, and we have seen Cholestin removed by Merck, and l-tryptophan persecuted in the past as well. At least now, methylfolate is back OTC, by Solgar, and some Red yeast rice is back, as well as tryptophan.

Blocking P-5-P OTC is a financial only move by Medicure. Please represent this nation, and not only Big Pharma so that the citizens of this country can continue to choose how to maintain health and prevent their own diseases.
I do agree that the supplement trade has abuses within it, by greedy characters who adulterate products. Please confine your attention to THEM, and not the general public by withholding useful products like P-5-P. The drug industry is really in trouble...4th leading cause of death in this country is due to RX drugs. We don't see supplement deaths on National statistics this way. Drug companies have abused the public long enough. Ghostwriting, withholding of negative studies, blatent study abuses, misleading doctors by drug salespeople, etc. Let's pay more attention to THAT...PLEASE.

Thank you.
(professional information deleted for this post)

Quote:

Originally Posted by Vowel Lady (Post 435186)

Not liking this!:mad:
Is it just P5P ?
This would not include all B6, right?
I have told EVERYONE about how my B50 tablets, some additional B12 has been VERY helpful for me.

No, Vowel Lady... P-5-P is an activated source of B6.

Not everyone can use the pyridoxine that is in most other vitamin mixtures. They cannot convert it to the active form themselves.

What is happening is that Medicure is testing activated B6 in trials...and hopes to have exclusive patent rights on ALL of it, so people cannot buy it themselves. P-5-P is not dangerous in any way. This is purely greed and financial manipulation.

I sent the link to hubby's client who owns a health food store.

TY MrsD.

Thanks for the heads up....I posted my objection today. Who knows....maybe it will have an effect.

Marlene

MrsD,

I can post on the clubs website. I have a section for articles. What do you think I should put?

Mrsd when would this go into effect.

I guess I better go stock up. :( :mad:

I get 100 tablets in a bottle from ecologial formulas.

I am not sure...

When Medicure's product is approved by the FDA, I would think
that is when the OTC status would be evaluated. Their B6 product is still in trials.

I ordered extra last week from iherb... that order has not arrived yet. I hope it is not delayed because of stocking issues.

I recall about 2 yrs ago there was a brief, "out of stock" issue with P-5-P. But that was temporary.

Some of the members here have sent answers to that petition I posted protesting the change. The more people who respond, the better our chances I think.

Here is one trial...
http://www.ncbi.nlm.nih.gov/pubmed/18381567?ordinalpos=1&itool=EntrezSystem2.PEntrez. Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.P ubmed_Discovery_RA&linkpos=1&log$=relatedarticles& logdbfrom=pubmed

Quote:

CONCLUSION: In this population of intermediate- to high-risk patients undergoing CABG surgery, MC-1 did not reduce the composite of cardiovascular death or nonfatal MI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00402506

PMID: 18381567 [PubMed - indexed for MEDLINE

But this one:
http://www.ncbi.nlm.nih.gov/pubmed/18371465?ordinalpos=1&itool=EntrezSystem2.PEntrez. Pubmed.Pubmed_ResultsPanel.Pubmed_DiscoveryPanel.P ubmed_Discovery_RA&linkpos=2&log$=relatedarticles& logdbfrom=pubmed

Quote:

Am Heart J. 2008 Apr;155(4):600-8. Epub 2008 Feb 21.Click here to read Links
A randomized, double-blind, placebo-controlled, multicenter study to evaluate the cardioprotective effects of MC-1 in patients undergoing high-risk coronary artery bypass graft surgery: MC-1 to Eliminate Necrosis and Damage in Coronary Artery Bypass Graft Surgery Trial (MEND-CABG) II--study design and rationale.
Mehta RH, Alexander JH, Emery R, Ellis SJ, Hasselblad V, Khalil A, Carrier M, Harrington RA, Tardif JC; MEND-CABG II Investigators.

Duke Clinical Research Institute, Durham, NC 27715, USA.

BACKGROUND: Coronary artery bypass graft (CABG) surgery is effective in relieving angina and improving survival and quality of life in patients with obstructive coronary artery disease; however, recurrent angina, myocardial infarction, neurological injury, and death can occur in the perioperative and postoperative period. MC-1 (pyridoxal 5'-phosphate) is a novel agent that has shown promise in reducing myocardial necrosis by reducing cellular calcium overload after percutaneous coronary intervention and CABG surgery in high-risk patients undergoing these procedures. METHODS: MEND-CABG II is a phase III study evaluating the efficacy and safety of MC-1 in reducing cardiovascular morbidity and mortality after CABG. High-risk patients undergoing CABG surgery will be randomly assigned to receive either MC-1 (250 mg/d) or matching placebo immediately before and continuing for 30 days after the procedure. The primary end point is the occurrence of cardiovascular death or nonfatal myocardial infarction through postoperative day 30. A total of 3023 patients were enrolled at 130 sites in Canada, the United States, and Germany between October 2006 and September 2007, with results anticipated shortly after completion of 90-day follow-up in March 2008. CONCLUSIONS: The data from the MEND-CABG II trial will establish whether peri- and postoperative treatment with MC-1 can decrease the short- and intermediate-term morbidity and mortality of high-risk patients undergoing CABG surgery.

PMID: 18371465 [PubMed - indexed for MEDLINE]

If they cannot show really good effects, perhaps the "drug" version of P-5-P will not be approved.
The FDA is not approving much these days!

M.D.'s in Los Angeles that treat "pyroluria"?????

Please help if anyone knows of an M.D. who treats pyroluria in L.A. or surrounding cities. I think ONA posted and was from Longbeach???
Thanks so much,
Beth

I think this is probably a hoax. I've heard stuff like this repeatedly--the FDA pulling vitamins and minerals off over-the-counter--and it's always been a hoax before. I don't see any good reason why they would do it, since pharmaceutical companies make a great deal of money from over-the-counter sales, too, especially multivitamins.

The only times I can recall the FDA pulling anything was when the supplements were outright dangerous, with reported deaths; and that's the way it ought to work.

It is not a hoax.... the request from the drug company exists on the FDA website.

While I was looking around PubMed the other day, I found 2 papers by this company on their P5P product used after heart procedures!

What we do not know is if the FDA will approve this move.

If the FDA chooses to NOT approve this move to RX status, I will expect this drug company to
BUY the patent for converting pyridoxine to P5P so they can control who buys/markets it.
Just like Merck does with methylfolate! They WILL do something, to preserve their money making
capability.

Quote:

Originally Posted by mrsD (Post 493391)

i wouldnt have thought about this being a patent issue, WHO has this patent now, and is there more than one possible process, ie another way that is not patented(able)??

The patent on the process to convert folic acid to methylfolate is held by Merck. It was one of their scientists who developed it.

You can read more here:
https://secure3.convio.net/aahf/site...rAction&id=334

One issue is 3rd party payment. Insurance companies will deny to pay for "drugs" if OTC is available. If no insurance coverage, then the company stands to not make much money, because patients won't pay the inflated prices reflecting the research.

The amount of P5P in nature is small... some meats have small amounts of it. The tablets available today are 50mg.
(some mixtures of it with other vitamins may be less).

Here is an example of the first step to controlling who gets P5P...
http://www.stockhouse.com/bullboards...4&l=0&pd=0&r=0
exclusive distribution rights.... just like Merck had with methylfolate.