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publius
2009-Feb-17, 06:56 PM
The FDA announced last Friday I believe that it is declaring a form of vitamin B-6, Pyridoxine HCL, to be a drug. The original "complaint" filed by a drug company that led to this decision is here:

http://www.cfsan.fda.gov/~lrd/fr051118.html

This company, Biostratum, has developed some drug which uses this form of B-6 to treat some kidney problems. This purely to protect the profits of that company. It is now illegal to sell any products containing this form of
B-6.

In the pipeline is another complaint, on behalf of another drug company, to do the same with "P5P", another form of B-6.

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648051908f

If they do that, B-6 will be completely illegal, requiring a $$$ prescription to get any form of it.


-Richard

mike alexander
2009-Feb-17, 09:04 PM
The FDA announced last Friday I believe that it is declaring a form of vitamin B-6, Pyridoxine HCL, to be a drug. The original "complaint" filed by a drug company that led to this decision is here:

http://www.cfsan.fda.gov/~lrd/fr051118.html

This company, Biostratum, has developed some drug which uses this form of B-6 to treat some kidney problems. This purely to protect the profits of that company. It is now illegal to sell any products containing this form of
B-6.

In the pipeline is another complaint, on behalf of another drug company, to do the same with "P5P", another form of B-6.

http://www.regulations.gov/fdmspublic/component/main?main=DocumentDetail&o=090000648051908f

If they do that, B-6 will be completely illegal, requiring a $$$ prescription to get any form of it.


-Richard


This is a case of clever lawyers using poorly-written law to pull a fast one (by any definition of reasonableness). And yes, (full disclosure) I make my living off the pharmaceutical industry.

Strictly speaking, pyridoxine, pyridoxamine and pyridoxine-5-phospahte are 'prodrugs' (forgive my use of 'drug' for a second), in the sense that the compounds themselves have no activity until enzymatic conversion to pyridoxal phosphate, the 'drug' that actually exerts the desired effect in the cells.

The idea that a natural-source compound can be patented or protected as a drug isn't new, of course (taxol comes to mind). A compound going through the FDA approval process for treatment of a disease or condition is just what is done (The IND, or Investigational New Drug, is the formal application of a company to the FDA to begin the review process for testing in humans and is done for all new drug entities, leading to enough testing to file an NDA, New Drug Application, which if approved allows marketing of the drug for the conditions tested).

When treating a specific condition it's not even a bad idea to produce a drug formulation, if for no other reason than the rules for purity, stability, potency and the like are much stricter for drugs than for supplements.

However. Here we have a compound (or a suite of compounds) that is a) naturally-occuring and widely available in the plant/animal food chain and b) is an essential cofactor for health. This does not pass the test of reasonableness in my view, even if the laws can be twisted to support the aforementioned claims.

On the plus side, nobody has gone after pyridoxine itself so far, which as a source of the active principle should be as good as pyridoxamine.

publius
2009-Feb-18, 02:47 AM
Thanks, Mike and I love Soupy, there. You change your avatar every other day or so, don't you? :)


Here's an old story from 2005 that sheds some light on this:

http://triangle.bizjournals.com/triangle/stories/2005/10/17/story2.html

Biostratum, the company involved, was having trouble getting funding for Phase III trials of their drug, which they called Pyridorin. The only active ingriedient turned out to be pyridoxamine, which was widely available as a supplement. And so, already $100M down the hole, they couldn't raise capital to continue as they couldn't get exclusive rights to the compound. They figure there's a $4B market in the US if the thing gets approval.

So they petitioned the FDA to do what it ended up doing. This just makes me sick. I'm putting Biostratum on my list of companies I won't do any business with at all costs.

The issue seems to be anyone can show evidence they were selling this stuff 15 years ago, when the DHSEA grandfathered in many such compounds.

In reading about this, I see the FDA has done this before with "red yeast rice", which contains a compound similiar if not identical to one of the lucrative statin drugs.

-Richard

tdvance
2009-Feb-18, 03:23 AM
you know, we'll be in trouble if someone comes up with a cure for something that involves drinking water....

publius
2009-Feb-18, 03:24 AM
Well, as a lark protest, I just ordered a boatload of pyridoxamine dihydrochloride supplements. :lol: If they're gonna ban something, by Jove, I want it.

ETA: I don't want to cross the line into advocacy, but I will note that besides the above, I'm writing a letter to both senators and my congressman, as well as the FDA. Forget e-mail or phone calls -- do a real, formal letter as they carry the most weight. And I'm sending a nasty letter to this Biostratum outfit. They won't give a rip about one person, but enough people did it, that might get their attention.

-Richard

publius
2009-Feb-18, 03:52 AM
Here's a long winded document on recommended nomenclature for the
B-6 family of compounds.

http://www.chem.qmul.ac.uk/iupac/misc/B6.html

It seems there was a history of ambiguity and confusion over what should be called what. "Pyridoxine" was apparently used a generic term for the whole B-6 family, and this document condemns that, and recommends just using
"B-6" for the B-6 family and gives recommended names for all the others. I would fuss about that mess, but considering what a little meticulous nut I can be about things I care about, I won't complain. :lol:

So, the banned compound is pyridoxamine, not pyridoxine. B-complex and B-6 products containing pyridoxine HCL will not be affected by this ruling. But any B-6 products that use pyridoxamine di-HCL will be banned. This latter is what I just ordered.

-Richard

publius
2009-Feb-18, 05:33 AM
you know, we'll be in trouble if someone comes up with a cure for something that involves drinking water....

Well, dehydration is a condition that can be cured by drinking water....... and inhalation of it can cause death, so it can be considered dangerous. :eek:


-Richard

mugaliens
2009-Feb-19, 12:01 AM
If they do that, B-6 will be completely illegal, requiring a $$$ prescription to get any form of it.

Are they outlawing meats, whole grain products, vegetables, and nuts, too?

:whistle:


Well, dehydration is a condition that can be cured by drinking water....... and inhalation of it can cause death, so it can be considered dangerous.

Uh-oh... I'd better turn off this humidifier, as this 50% humidity must be half-killing me!

I'm sorry, publius, I really am. I couldn't resist, though, as tired as I am, as you sort of stepped into these...

Go ahead, smack me upside my verbal head... :)

publius
2009-Feb-19, 12:41 AM
Uh-oh... I'd better turn off this humidifier, as this 50% humidity must be half-killing me!

I'm sorry, publius, I really am. I couldn't resist, though, as tired as I am, as you sort of stepped into these...

Go ahead, smack me upside my verbal head... :)

:) Okay, smarty pants. I clearly said "drinking water", which obviously implies the liquid state of H2O, the inhalation of too much of which *can* (not will) lead to death.

And on a more serious note, the offending "drug" compound, pyridoxamine, is indeed present naturally. The family of B-6 is confusing, but if I've got it right, the banned compound, pyridoxamine, is present primarily in animal sources, fish being particulary high, I think. The pyridoxine form is the one normally found in plant sources.

And that, I just don't understand. How can a naturally occuring molecule, a necessary cofactor for human life, be declared a drug and a company given exclusive rights to it? The FDA legalistic phrase is "adulterated with pharmaceuticals". That is, any seller or manufacturer of pyrioxamine supplements will be guilty of selling a product so adulterated with drugs.

So that seems to mean that any fish/meat products sold are likewise adulterated with pharmaceuticals. I'm sure there is some legalistic hair-splitting involved there, but I don't get it.

-Richard

Gillianren
2009-Feb-19, 05:49 AM
I'm not sure "banned" is the right term, here.

Tensor
2009-Feb-19, 05:50 AM
So that seems to mean that any fish/meat products sold are likewise adulterated with pharmaceuticals. I'm sure there is some legalistic hair-splitting involved there, but I don't get it.

-Richard

You're trying to figure out if a government ruling makes sense? I thought you were more intelligent than that Richard. :lol:

sarongsong
2009-Feb-19, 10:38 AM
I'm not sure "banned" is the right term, here.Is there another word for synonym? :)

Tensor
2009-Feb-19, 01:34 PM
Is there another word for synonym? :)

Sure, anti-antonym. :p

Gigabyte
2009-Feb-19, 02:37 PM
I'm not sure "banned" is the right term, here.


Docket ---- FDA-2007-P-0410
Docket Title -- Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate

SeanF
2009-Feb-19, 03:08 PM
Docket ---- FDA-2007-P-0410
Docket Title -- Prohibit the marketing of dietary supplements containing Pyridoxal 5'-Phosphate

Which tends to make Gillianren's point. Prohibiting the marketing of dietary supplements would not seem to preclude the selling of a steak that naturally contains the substance in question.

Hence the substance is not "banned."

mike alexander
2009-Feb-19, 04:44 PM
It's mainly high-stakes wordplay.

I'll give an example. Consider ibuprofen. Originally a prescription-only compound, it was eventually converted to over-the-counter status by the FDA, being sold in a lower-potency form. You can still get the prescription form at, say, 800mg per tablet, or the OTC at 200mg per tablet. In terms of effects, taking four OTC pills is going to be the same in every way to taking one 800mg pill, with the difference the OTC pills will probably cost less.

Gigabyte
2009-Feb-19, 05:06 PM
No, the OTC same dose of 800 mg will contain far more non medical substances. On the positive side, people tend to not want to take 8 capsules (equivalent of two 800mg prescription pills), meaning there is much less chance of overdose with the OTC pills.

What does this have to do with somebody trying to declare a B vitamin a drug?

Euniculus
2009-Feb-19, 06:00 PM
No, the OTC same dose of 800 mg will contain far more non medical substances. On the positive side, people tend to not want to take 8 capsules (equivalent of two 800mg prescription pills), meaning there is much less chance of overdose with the OTC pills.


With very few exceptions, people should not be taking 1600mg of ibuprofen at a time.

800mg should only be taken every eight hours vs 4-6 hours for 400mg.

Please be very careful about posting drug doses unless you're a healthcare professional. Repeated doses of 1600mg at a time can cause some very serious and potentially fatal health issues. Even 800mg is too much for people who take certain very commonly prescribed medications.

Euniculus
2009-Feb-19, 06:08 PM
And that, I just don't understand. How can a naturally occuring molecule, a necessary cofactor for human life, be declared a drug and a company given exclusive rights to it? The FDA legalistic phrase is "adulterated with pharmaceuticals". That is, any seller or manufacturer of pyrioxamine supplements will be guilty of selling a product so adulterated with drugs.


Happens all the time, bear in mind there are major issues with supplements in regards to regulations, purity, and bioavailability.

Some examples of drugs that are naturally occuring molecules:

B-12 injections, oral B-12 supplements are poorly absorbed.

Gabapentin

L-carnitine

Lithium

Adrenaline (epinephrine and norepinephrine)

These are just a few, there are many more.

Nick Theodorakis
2009-Feb-19, 07:19 PM
It's mainly high-stakes wordplay.

I'll give an example. Consider ibuprofen. Originally a prescription-only compound, it was eventually converted to over-the-counter status by the FDA, being sold in a lower-potency form. You can still get the prescription form at, say, 800mg per tablet, or the OTC at 200mg per tablet. In terms of effects, taking four OTC pills is going to be the same in every way to taking one 800mg pill, with the difference the OTC pills will probably cost less.

Although the prescription might be covered by the patient's insurance and might have a lower out-of-pocket cost to the patient.

Nick

Nick Theodorakis
2009-Feb-19, 07:28 PM
...
And that, I just don't understand. How can a naturally occuring molecule, a necessary cofactor for human life, be declared a drug and a company given exclusive rights to it? The FDA legalistic phrase is "adulterated with pharmaceuticals". That is, any seller or manufacturer of pyrioxamine supplements will be guilty of selling a product so adulterated with drugs.
...


You are combining two different regulatory processes. The "exclusive rights" part has nothing to do with the FDA and is a function of the patent office. The FDA monitors drugs, and if something is sold or marketed as having a therapeutic function, it falls under the purview of the FDA regardless of its origin as a natural or synthetic compound.

Nick

Gillianren
2009-Feb-19, 07:38 PM
Although the prescription might be covered by the patient's insurance and might have a lower out-of-pocket cost to the patient.

I don't pay anything for my prescription; it's the one part of my insurance that's actually really good. (400 mg tabs.) And, as pointed out above, we really do want certain naturally-occurring compounds strongly regulated. Not just anyone should be taking lithium! But it strikes me that the word we're looking for is "regulated," not "banned." If it were banned, no one could sell it, right?

publius
2009-Feb-19, 07:56 PM
You are combining two different regulatory processes.
Nick

Regardless of legal hair splitting, Biostratum went to the FDA to get it to ban supplements containing the compound in question, pyridoxamine dihydrochloride. Was Biostratum concerned about the safety and efficacy of this compound? No, it was concerned with its own funding and future profits. Since the compound was widely available as a supplement, they couldn't raise enough capital. Did they go to the patent office? No, they went to the FDA.

In a sane world, you'd think if a vitamin was found to be useful in treating some disease, they would investigate that as it is and if it proved good, that would be great. Nice cheap treatment. But no, they have to first ensure they can charge $10 a pill or whatever for the stuff by getting the FDA to put the competition out of business before they even think about completing the clinical trials.

Oh, and yes, all supplements containing this form of B-6 are "banned" by any reasonable use of the word. And yes, if there was any way Bisotratum thought it could get a cut out of the sales of meat and fish with this compound in it, they would. Maybe charge a royalty for their wonder "drug".


-Richard

Gillianren
2009-Feb-19, 10:12 PM
Oh, and yes, all supplements containing this form of B-6 are "banned" by any reasonable use of the word. And yes, if there was any way Bisotratum thought it could get a cut out of the sales of meat and fish with this compound in it, they would. Maybe charge a royalty for their wonder "drug".

Do you know that, or is it more of your traditional hatred for the pharmaceutical industry?

Look, I'm not saying that what's being done is right. However, I still dispute your use of the word "banned," because clearly, at least one company has the right to sell it. "Extremely limited." "Regulated." But not "banned."

mike alexander
2009-Feb-19, 11:39 PM
No, the OTC same dose of 800 mg will contain far more non medical substances. On the positive side, people tend to not want to take 8 capsules (equivalent of two 800mg prescription pills), meaning there is much less chance of overdose with the OTC pills.

What does this have to do with somebody trying to declare a B vitamin a drug?

Just trying to point out that the same active compound can be sold as a regulated substance and an unregulated one (prescription vs. OTC).

Not sure what you mean by non medical substances. Most pills or tablets contain fillers, bulking agents, stabilizers, coatings and such. I just walked out to the lab to weigh a generic 200mg ibuprofen tablet and found it weighs 335mg. All things being equal (and they always are...) I suspect the ratio of active ingredient to inactive ingredients is pretty constant regardless of the pill dosage, since the texture, adhesion, water retention and other characteristics of the material necessary for good pressing don't change much with size.


I don't have data on overdose, but I suspect that it's just as easy to OD on small pills as large ones. One method is to take some for a condition, decide a while later you didn't take enough, take some more, and so on. I wouldn't be surprised if overdoses in absolute numbers increased after OTC status just because so many more people were taking it in the first place.

I have occasion to take a largish dose for a condition of mine, and my physician told me that since a generic bottle is so cheap (and you probably have a bottle on hand, anyway), just do his prescribed level with OTC pills.

Gigabyte
2009-Feb-20, 12:04 AM
With very few exceptions, people should not be taking 1600mg of ibuprofen at a time.

I thought I was making that point. Some idiot might easily pop two prescription pills (1600mg), you know, if one is good, two are better, but might hesitate to take 8 pills, when it says take two on the bottle.

But back to B6.



Some examples of drugs that are naturally occurring molecules:


Describing essential nutrients as "drugs" is some sort of newspeak that serves somebody, I not always sure who. And there is no doubt some nutrients in large or purified amounts have profound effects on the human body.

Gabapentin is not a good example, it is an artificial molecule, that mimics a natural one.


Years ago, some big pharma companies got busted trying to corner the market on certain supplements. This new tactic looks promising. Why stop at B6? Just patent all the B vitamins.

Euniculus
2009-Feb-20, 01:05 AM
Gabapentin is not a good example, it is an artificial molecule, that mimics a natural one.


Ok, fine.

Testosterone (this is a controlled substance too)

Vitamin K (used to treat warfarin overdose)

Zinc in various forms

Some prenatal vitamins are Rx only

Opiods (our brain produces them)

As far as B6 is concerned, why stress about it? There are other forms available OTC and they all convert to pyridoxal-5-phophate in the body. Or, just eat a better diet and you'll get all you need.

Gigabyte
2009-Feb-20, 01:07 AM
It's the "foot in the door" principle, or the "camels nose under the tent" if you will.

First it's an amino acid, next a B vitamin, before you know it, essential nutrients will be illegal to posses with out a prescription. Which of course makes your brain illegal.






















Wait, that is already the case.

Euniculus
2009-Feb-20, 01:14 AM
GHB is also a naturally occuring molecule found in our CNS.

It used to be available OTC, but now is illegal. Something about being used as a date rape drug.

The FDA does permit it by Rx because it has legitimate medical uses, but it's very tightly controlled.

publius
2009-Feb-20, 01:16 AM
I finally found a good clip of something. This is a portion of the testimony of Harry Markopolos, the poor guy who for 10 years was screaming that Madoff was a fraud to deaf ears of the SEC. He's being questioned by Rep. Grayson:

http://www.youtube.com/watch?v=rwUH9iA0GcM


Starting at 2:55m into the clip, Rep. Grayson asks Markopolos about the concept of "regulatory capture", which is when a regulatory agency becomes "captured" by the industry it is supposed to regulate, looking out for that industry's interests rather than the public.

Guess who Markopolos names? The FDA in addition to the SEC as prime examples. :) This pyrioxamine ban is a perfect example of that.

-Richard

Euniculus
2009-Feb-20, 01:17 AM
It's the "foot in the door" principle, or the "camels nose under the tent" if you will.

First it's an amino acid, next a B vitamin, before you know it, essential nutrients will be illegal to posses with out a prescription. Which of course makes your brain illegal.


Wait, that is already the case.


Quite an overreaction don't ya think?

I'm not denying that big pharma has it's own monetary interests at stake. I could rant and rave for hours about some of their unethical practices.

However, this is not one of them.

Euniculus
2009-Feb-20, 01:21 AM
The FDA in addition to the SEC as prime examples. :) This pyrioxamine ban is a perfect example of that.

-Richard



It is not banned!!!

Gigabyte
2009-Feb-20, 01:31 AM
No, it is actually true. Not only your brain, but your entire body is currently illegal, due to the "drugs" found in all tissues. If you extracted the natural substances in your body, they become illegal to posses. Brave new world indeed.

While off topic, the same is also true for drinking water, due to contamination by drugs, but that is a whole nother topic.

In regards to wording, if the FDA rules that nobody can sell B6, it is not banned, it is just way more expensive, and hard to get.

If this stands up, it also means multivitamin supplements will have to not contain B6, which is, of course, madness.

publius
2009-Feb-20, 01:35 AM
It is not banned!!!

Can any supplements containing it be sold? Those supplements are BANNED. Every outfit selling them will soon get a cease and desist order from the FDA. This is to allow Biostratum to have exclusive rights to sell the compound as a drug (providing trials go favorably) with an estimated
$4B/year market. Read that 2005 article I linked above. Biostratum was in a pickle as it *could not raise any more funds* since the active compound in its wonder drug turned out to be this nice, simple, cheap vitamin freely available as a supplement. No big bucks. So get your bought and paid for buddies at the FDA to make it illegal to sell that cheap vitamin. Now you can raise the money on expectations of high returns.

Darn fine way to run a health care railroad.


-Richard

Euniculus
2009-Feb-20, 01:36 AM
In reading about this, I see the FDA has done this before with "red yeast rice", which contains a compound similiar if not identical to one of the lucrative statin drugs.

-Richard

Despite the "ban" it is readily available. I know of several places close to my home that sell it.


Besides, statin drugs can have some really nasty side effects (rhabdomyolyis, anyone?) and they also interact with grapefruit juice and many common antibiotics/antifungal drugs.

I'm for the FDA wanting to keep statins Rx only.


Besides, I'm only a pharmacist, what do I know?

Euniculus
2009-Feb-20, 01:40 AM
Can any supplements containing it be sold? Those supplements are BANNED. Every outfit selling them will soon get a cease and desist order from the FDA. This is to allow Biostratum to have exclusive rights to sell the compound as a drug (providing trials go favorably) with an estimated
$4B/year market. Read that 2005 article I linked above. Biostratum was in a pickle as it *could not raise any more funds* since the active compound in its wonder drug turned out to be this nice, simple, cheap vitamin freely available as a supplement. No big bucks. So get your bought and paid for buddies at the FDA to make it illegal to sell that cheap vitamin. Now you can raise the money on expectations of high returns.

Darn fine way to run a health care railroad.


-Richard

I read the article. There are other forms of B6 supplements available and if you eat a balanced diet, you should be getting sufficient B6 anyway.

Again, I do not deny big pharma has some nasty practices, but the FDA is not in bed with them.

publius
2009-Feb-20, 01:46 AM
Besides, I'm only a pharmacist, what do I know?

Well, glad to you know you. I'm friends with several local pharmacists, one of whom helps keep me up to date on all these Pharma shenanigans. Heck, for those who think I hate Pharma, they ought to hear that guy rant and rave..........


-Richard

publius
2009-Feb-20, 02:32 AM
...but the FDA is not in bed with them.

Well, many disagree, including some of the FDA's own scientists, who, as this WSJ articles, recently wrote a letter to the Obama transition team about FDA corruption:

http://online.wsj.com/article/SB123142562104564381.html

This is just the latest of course. This group is concerned about medical devices.

-Richard

Euniculus
2009-Feb-20, 02:46 AM
Well, many disagree, including some of the FDA's own scientists, who, as this WSJ articles, recently wrote a letter to the Obama transition team about FDA corruption:

http://online.wsj.com/article/SB123142562104564381.html

This is just the latest of course. This group is concerned about medical devices.

-Richard


There are shady individuals on both sides. That doesn't mean the FDA as a whole is corrupt.

mike alexander
2009-Feb-20, 02:55 AM
Most of the problems I've seen with the FDA occur at the interface of regulation and politics. More than that would probably violate board rules.

Gillianren
2009-Feb-20, 03:48 AM
Besides, statin drugs can have some really nasty side effects (rhabdomyolyis, anyone?) and they also interact with grapefruit juice and many common antibiotics/antifungal drugs.

Oh, I had a friend who was on one of those! As I recall, there were other possible nasty interactions, but she didn't mind the grapefruit juice one, because she doesn't like the stuff anyway. But I do keep going back in my head to lithium. (Probably because it's one of the ones they could theoretically put me on, though my doctor says he won't.) It's about the thirty-second most common element in the universe--admittedly, I don't know how common the version used in psychiatric treatment is--and we most assuredly want it regulated.

HenrikOlsen
2009-Feb-22, 03:14 PM
Can any supplements containing it be sold? Those supplements are BANNED.
Try to get your head around this: if there's anyone who can sell them legally, then it's not a ban.

Why is it that you can think so clearly when discussing economics but let your emotions get in the way of even basic english when it's about the drug industry?

mugaliens
2009-Feb-22, 11:41 PM
No, it is actually true. Not only your brain, but your entire body is currently illegal, due to the "drugs" found in all tissues. If you extracted the natural substances in your body, they become illegal to posses. Brave new world indeed.

Terrific.

So when I hit the gym, I'm now guilty of manufacturing, possessing, and consuming illegal and/or controlled substances. All within the first 5 or 10 minutes, which is when the endorphins begin to flow...

Terrific.

mugaliens
2009-Feb-23, 12:05 AM
It's about the thirty-second most common element in the universe--admittedly, I don't know how common the version used in psychiatric treatment is--and we most assuredly want it regulated.

What? The element, or the drug? It's the salts of lithium which are used to treat the mania and depression of bipolar. Or are you referring to it's use in meth production? Why not just track pseudoephedrine sales, instead?

The problem is that lithium is used in so many different forms throughout industry that it would be impossible to regulate the element. Currently, there is more than 30 million tons of the stuff floating around in one form or another.

And that's just what's been produced. It's as common as Chlorine in the Earth's crust, so banning the element will literally get us nowhere.

HenrikOlsen
2009-Feb-23, 12:42 AM
Which doesn't stop regulating its pharmaceutical use from being a rather good idea:)

mike alexander
2009-Feb-23, 12:52 AM
Which doesn't stop regulating its pharmaceutical use from being a rather good idea:)

Henrik is just making good sense. Natural-source substances such as cannabinoids and opiates are also controlled. There are some digoxin alkaloids in my flower garden, and there they will stay.

If you really ever get the desire to pop open a lithium battery and start suckin' it's your lookout. But producing something with consistent purity and potency, with quality control, is really best done by people with experience and expertise.

I'm not defending poor or unethical pharmaceutical practices, just saying good and ethical practices do produce a good product.

sarongsong
2009-Feb-23, 01:22 AM
...good and ethical practices do produce a good product.What percentage of these materials are coming from China and, if significant, how is their integrity maintained?

mike alexander
2009-Feb-23, 04:02 PM
What percentage of these materials are coming from China and, if significant, how is their integrity maintained?

Only the lead-based ones are made in China.


OK, OK. I feel a general statement (good and ethical practices do produce a good product) is of the 'hold these truths to be self evident' variety. Besides, how about 'Hecho en Mexico'? Does Taiwan count as well? Singapore? Or this (http://query.nytimes.com/gst/fullpage.html?res=950DEED91539F937A3575BC0A96F9482 60) from the good ol' US of A.

Integrity is maintained by proper manufacturing controls and testing along the production pipeline, as with any proper manufacturing process. If materials or finished product are being imported to the US the proper US authority should be checking. If agencies such as FDA aren't doing their job because of incompetence, it should be rooted out. If they are underfunded for their mandate, write your congressman and demand more resources be put into the problem. Warning: the previous sentence implies government will have to spend money

Gigabyte
2009-Feb-23, 11:17 PM
Side note. I had a friend who took large amounts of B6 for a long period of time, to combat chronic pain.

Seriously bad consequences resulted. She wasn't making this up (http://en.wikipedia.org/wiki/Pyridoxine#Medicinal_uses).