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Big Pharma trying to take P5P off the market


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8 replies to this topic

#1 rwac

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Posted 16 January 2009 - 01:31 AM


Taken from here:
http://brain.hastypa...9498#post309498

You will want to read this:

http://www.knowtheli...om/?q=node/2153

http://www.fdalawblo....n-petitio.html

Here is the petition...
http://www.regulatio....0000648051908f

To log a protest comment, click on the little yellow balloon and type in your
comments. It is on line 6

The more who complain, the more likely we may be heard.



#2 FunkOdyssey

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Posted 16 January 2009 - 05:15 AM

Here is the petition...
http://www.regulatio....0000648051908f

To log a protest comment, click on the little yellow balloon and type in your
comments. It is on line 6

The more who complain, the more likely we may be heard.


I submitted a comment in protest. That is totally outrageous and ridiculous. Are they going to ask for a ban on animal meat too, since it is "adulterated" with their new "drug"?

Edited by Michael, 18 February 2009 - 03:35 PM.


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#3 StrangeAeons

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Posted 16 January 2009 - 09:42 PM

I'm not totally up to speed on the various forms of B6; Wikipedia claims there are seven forms, and the most common one sold as a supplement is pyridoxine (which I actually own). I know there's also a big deal over pyridoxamine, which is supposed to be a better form of B6 but has proven difficult to obtain lately.

I'm outraged, regardless, because this is a boneheaded maneuver that violates the spirit of our country; but before we get all in a tizzy, does anybody know if this ban extends to all forms of B6 or just P5P? I wasn't even aware of P5P being available for retail, to be honest.

#4 FunkOdyssey

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Posted 16 January 2009 - 09:46 PM

before we get all in a tizzy, does anybody know if this ban extends to all forms of B6 or just P5P? I wasn't even aware of P5P being available for retail, to be honest.

It is just for P5P. P5P is the form of B6 found in Ortho-Core and it is available from many supplement manufacturers. You'll find at least eight P5P products over at iherb. Pyridoxamine is still available from LEF.

P5P has similar and in some ways superior anti-glycation properties when compared to pyridoxamine and probably has excellent potential for treatment and prevention of diabetic complications. I'm willing to bet that is the angle they are taking for development as a drug.

Edited by Michael, 18 February 2009 - 03:36 PM.


#5 niner

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Posted 16 January 2009 - 09:58 PM

Couldn't any company use this ploy for any new supplement? It would be kind of like Sirtris trying to get sales of resveratrol stopped. I suppose there's some angle regarding when they submitted their package to the FDA and when the supplement hit the market, but this seems problematic to say the least. If it were an obscure supplement that had never been proven safe or effective, and a company did the work to generate data saying that it was, this would be more of a grey area. I wouldn't want to discourage such work, but I also don't want the reward for the work to vastly outweigh the capital put at risk. It's not very helpful to have a compound shown to be useful if no one can afford to use it. At least drug patents have limited lifetimes.

There's at least one thing I can say about these guys: They are not Big Pharma. They are Little Pharma. Kind of a Mom & Pop Pharma shop. But they still have lawyers.

#6 rwac

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Posted 16 January 2009 - 11:34 PM

P5P has similar and in some ways superior anti-glycation properties when compared to pyridoxamine and probably has excellent potential for treatment and prevention of diabetic complications. I'm willing to bet that is the angle they are taking for development as a drug.


It appears that's one of the angles.
They're looking at a bunch of things.
Blood pressure, glycemic control, glycation, lipids.

From http://www.medicure.com/matched.html

What they refer to as MC-1 is P5P

Results from Blood Pressure Endpoints: The results of MATCHED demonstrate the positive clinical effects of MC-4232 on primary and secondary blood pressure endpoints, including both systolic and diastolic measurements:

  • The 300mg/20mg (MC-1/lisinopril) dose of MC-4232 had a statistically significant reduction of 12.0 mmHg (p<0.0001) from baseline over 8 weeks on the primary endpoint of mean daytime ambulatory systolic blood pressure (MDASBP).
  • The 300mg/20mg dose of MC-4232 reduced MDASBP by 12.0 mmHg over 8 weeks as compared to a 7.5 mmHg reduction with lisinopril alone, equating to an additional 4.5 mmHg (p=0.13) reduction, demonstrating the improved antihypertensive effects of MC-4232 over lisinopril alone.
  • In the secondary endpoint of reduction in mean daytime ambulatory diastolic blood pressure (MDADBP), the 300mg/20mg dose of MC-4232 reduced MDADBP by 7.5 mmHg over 8 weeks as compared to a 4.1 mmHg reduction with lisinopril alone, equating to an additional 3.4 mmHg (p=0.06) reduction, again demonstrating the improved antihypertensive effects of MC-4232 over lisinopril alone.

Results from Metabolic Endpoints:
The results of MATCHED also demonstrated the positive clinical effects of MC-4232 on primary and secondary metabolic endpoints, including glycemic control as measured by fasting serum glucose and glycated hemoglobin (HbA1c), as well as lipid control, after 16 weeks of treatment.

  • The 300mg/20mg dose had a statistically significant reduction of 1.45 mmol/L (p=0.026) versus placebo on the primary endpoint of fasting serum glucose.
  • In those patients with HbA1c greater than the prespecified level of 8.0%, the 300mg/20mg dose had an absolute reduction of 0.63% (p=0.27) compared to placebo. This exceeds the regulatory requirements in HbA1c reduction of ≥0.40% for antidiabetic therapeutics. The majority of the patients in the study were well controlled with current antidiabetic therapy, with less than 19% exceeding 8.0% HbA1c.
  • In those patients with elevated triglycerides (>1.7mmol/L), the 300mg/20mg dose of MC-4232 provided a statistically significant reduction of triglyceride levels by .70 mmol/L (p=0.04) versus baseline.
On all key metabolic and blood pressure endpoints the 300mg/20mg and 1000mg/20mg doses of MC-4232 demonstrated comparable clinical efficacy. The study results also demonstrated that MC-4232 was safe and well tolerated at all dose levels.



#7 StrangeAeons

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Posted 17 January 2009 - 12:09 AM

From http://www.medicure.com/matched.html

What they refer to as MC-1 is P5P


I know 300mg of Pyridoxine (much less 1000mg) is way high and has the potential for peripheral neuropathy after a few months; I don't know how P5P compares, but I imagine part of banning P5P as a supplement is so that people won't think of it as B6 and look at how ridicuously high this is per the RDI. I would also have to imagine this is supposed to be yet another "brilliant" invention on account of ,"oooh, look, we thought to mix this with an ACE inhibitor! Whod've thunk?"

Edited by Michael, 18 February 2009 - 03:37 PM.


#8 hamishm00

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Posted 20 January 2009 - 08:54 AM

Solgar's B Complex which I take has 100mg per each tablet (5000% of the RDA).

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#9 kismet

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Posted 20 January 2009 - 03:15 PM

I know 300mg of Pyridoxine (much less 1000mg) is way high and has the potential for peripheral neuropathy after a few months; I don't know how P5P compares,

Personally I don't know if you have got the pyridoxamine facts right (I hope not, I wish it wasn't neurotoxic like pyridoxin), but most people say P5P as the active form of b6 is not neurotoxic. I've even heard that pyridoxin competes with P5P and is therefore neurotoxic.

Oh, no!
Neurochem Pathol. 1985 Fall;3(3):159-67.
Neurotoxicity of pyridoxine analogs is related to coenzyme structure.
Windebank AJ.

In very high doses, pyridoxine is neurotoxic in humans and other animals. Using morphometry and a model system of dorsal root ganglion neurons in culture, we found that several analogs of pyridoxine were neurotoxic in vitro. Those that may be converted into active coenzymes--pyridoxal, pyridoxine, and pyridoxamine--were almost equal in toxicity. Pyridoxic acid, which is not active, was nontoxic. Pyridoxamine 5-phosphate, which cannot enter cells, also was nontoxic. Several hypotheses that link coenzyme function to toxic effect are described.

Oh, yes?

J Appl Toxicol. 2004 Nov-Dec;24(6):497-500.
Pyridoxine (vitamin B6) neurotoxicity: enhancement by protein-deficient diet.
Levine S, Saltzman A.

...
The vitamers related to pyridoxine (pyridoxal, pyridoxamine) and the coenzyme (pyridoxal 5-phosphate) did not cause clinical signs or lesions similar to those produced by pyridoxine even when injected in maximum tolerated doses. Neither a protein-deficient diet nor bilateral nephrectomy changed the results with the vitamers.

Edited by kismet, 20 January 2009 - 03:18 PM.





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