What!? Are they nuts? FDA must be working for big pharma

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godsilove

Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#46  Post by godsilove » Sat Nov 14, 2009 10:46 am

ofonorow wrote:The difference between orthomolecular and toxic substances is that after ortho substances reach "toxic" dosages, you simply stop or lower the dosage. The "bad" effect is usually not debilitating, and it quickly wears off. No one is killed or really harmed. The body knows how to get rid of any excess, and the proof is that no one is poisoned by these substances. (There is at least one case of a forum poster who might disagree w/r to vitamin A, but even he is alive to file his report.)

We use the same term, "toxicity" for prescriptions and vitamin/minerals, but these orthomolecular substances are not "deadly toxic." They are not poisons. In fact there are no known lethal dosages for either vitamin C or lysine.


Toxicity from compounds other than vitamins and minerals can also be reversible and need not be permanent. The body is capable of metabolizing and excreting many of these substances as well, and for good reason. Our diet contains millions of compounds other than nutrients, and the body needs to be able to excrete them if they are absorbed into the bloodstream.

Vitamin and mineral supplements thankfully have a large therapeutic window and are often available in dosages close to the RDI, i.e. the amount needed to treat deficiency. In effect, it is difficult to get a lethal overdose from them. Nonetheless, while deaths from vitamins and minerals are extremely rare, they have been reported in the literature (e.g. here and here, and here). So what you call "orthomolecular" can definitely be "deadly toxic", in addition to having non-fatal toxicities.


I learned long ago that most medical professionals are taught that vitamins and minerals are not much different than prescriptions, and thus should be categorized with drugs. ( I stand by the reasoning why this is taught this way, however, there is a significant distinction and that is the value of Pauling's orthomolecular classification.)

Vitamins and minerals are not poisons - drugs are.
[/color]


While vitamins and minerals are generally safer than drugs, they too can be poisonous, as the literature shows.

The problem with this is who decides? Government bureaucrats don't have a clue, and this kind of thinking, while protecting well-funded interests who can afford to run studies, does little to protect the public interest. And as we have discussed, there is too much money involved to trust the "science" unfortunately. (I might remind you of the fact that "At least 70 pharmaceutical drugs are on the market after passing clinical trials based on fraudulent data provided by a California doctor," said Kurt Eichenwald, an investigative reporter for The New York Times...)


Fraud happens, but your argument is really just attempting to poison the well. There have no doubt been cases of rotten apples who have committed fraud, sometimes on a shockingly large scale, but it is fallacious to conclude that this describes the entire scientific and medical community (just as I'm sure you would agree that Kevin Trudeau is not reflective of all proponents of "alternative" medicine)

The solution is not to throw to find better ways of minimizing fraud and detecting it before the perpetrators become more brazen.

A much preferable approach is to allow the marketing unless a significant body of evidence indicates the marketing is false. You seem to want a priori proof, or up front. I completely agree w/r to poisonous toximolecular drugs!


How is this a preferable system? That would mean that anybody can market a concoction as a cure for cancer, and unless and until somebody else provides evidence against this, it would remain on the market.

Regarding the generally safe and possibly remarkable substances, I would rather have the well -funded drug companies funding studies to prove the competing substance doesn't work, e.g. vitamin C doesn't work for colds, before a claim is denied. (Of course, this isn't perfect either.)


If the company is marketing that product, then I would agree that they should conduct the studies. In this case, P&G should conduct studies to show that their combination is safe and more effective than Nyquil/Dayquil alone. But I don't agree that other pharmaceutical companies should conduct studies - that would be absurd.

The fundamental difference is that you trust pharmaceutical companies, and their well funded research, and I generally distrust them.


It's not a case of black or white. I'm not oblivious to the selective reporting, ghostwriting, methodological biases, etc that can occur in pharmaceutical research - especially when marketing people get involved. The difference is that I do not write off all this research as fraudulent and I try not to make hasty generalizations.

In my simple world, 2 plus 2 equals 4. Physicians in the USA, in general, have no real idea what CoQ10 is used for, or which drugs deplete it. Dr. Langsjoen is an expert on CoQ10, and his opinion makes a great deal of sense, the more you know about CoQ10 and its crucial role in energy production in all cells. Out of curiosity, what is your theory of the cause of the epidemic of heart failure?


Well, let's look at the rise in heart failures more closely. Lovastatin was approved in 1987. On the other hand, epidemiological data shows that the rising trend in incidence of heart failure in the US began rising as early as the late 70s, before statins were even on the market.

Image

So even in a simple 2+2=4 world, this ought to suggest that there are other factors at play. As for what these other factors are, without evidence I am hesistant to try and pinpoint them.

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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#47  Post by ofonorow » Sun Nov 15, 2009 4:30 am

Toxicity from compounds other than vitamins and minerals can also be reversible and need not be permanent. The body is capable of metabolizing and excreting many of these substances as well, and for good reason. Our diet contains millions of compounds other than nutrients, and the body needs to be able to excrete them if they are absorbed into the bloodstream.


Yes, and this supports which argument? That modern drugs are/aren't poisons? By the way, to the extent this is true, the body can "detoxify" itself, the substance in question fits within the orthomolecular classification. What seems to be happening in pharmaceuticls is that modern biochemists are able to "adjust" natural molecules, to make them more potent or what-ever, and they become more toxic to certain people. This is why the term "bioidentical" has become popular. Same molecule, say of testosterone, that the body has evolved to make.

For these type of discussions, the basic toxicity studies are appropriate. What is the dosage that kills half the laboratory rats? As I mentioned, there are no known levels of either vitamin C or lysine that kill. I should look this up, but I believe the toxic (lethal) dosage of aspirin is less than 1 gram. Pauling spends two chapters in the book discussing this issue, and again, it is worth reading and then I would be interested in your criticism. (I don't not believe that your education opens up this alternative view of the world.) Pauling discusses one substance,ordinary aspirin and its toxicity, versus every vitamin with a toxicity concern. Night and day.



Vitamin and mineral supplements thankfully have a large therapeutic window and are often available in dosages close to the RDI, i.e. the amount needed to treat deficiency. In effect, it is difficult to get a lethal overdose from them. Nonetheless, while deaths from vitamins and minerals are extremely rare, they have been reported in the literature (e.g. here and here, and here). So what you call "orthomolecular" can definitely be "deadly toxic", in addition to having non-fatal toxicities.



Yes, and as I mentioned, I can find literature that deaths have occurred from drinking too much water. (Do we need a government agency to warn people about water ? To make sure they don't drink in excess? People are pretty smart and can figure out these differences for themselves.)


How is this a preferable system? That would mean that anybody can market a concoction as a cure for cancer, and unless and until somebody else provides evidence against this, it would remain on the market.


Absolutely! The Free market, I love it! What a concept. (As you well know, unbiased, private third parties would arise to take the place of the FDA. Actually, the FDA and its "approval" haven't stopped people from migrating to alternative medicine in vast numbers... Love that Suzzane Summer's new book on Alt. Cancer treatments is a number one best seller!

p.s. if there were truly a free market, heart disease would have been abolished (cured) more than 10 years ago. Millions of people would still be living, etc. etc. etc


The fundamental difference is that you trust pharmaceutical companies, and their well funded research, and I generally distrust them. [/color]


It's not a case of black or white. I'm not oblivious to the selective reporting, ghostwriting, methodological biases, etc that can occur in pharmaceutical research - especially when marketing people get involved. The difference is that I do not write off all this research as fraudulent and I try not to make hasty generalizations.


Good for you, but how can you decide? The obvious best studies are those not funded or supported by the interests being studied. But you cannot find these anymore, University grants come from Big Pharma, and the NIH is basically an arm of Big Pharma. For example, if a study supports some wonderful role for a statin - I simply do not believe it. However, if a Big Pharma supported study found a problem or concern about a statin - something that might cost them their share of the $20 billion market, I WOULD BELIEVE THAT STUDY :)

Whether I believe it matters not one iota, of course.

In my simple world, 2 plus 2 equals 4. Physicians in the USA, in general, have no real idea what CoQ10 is used for, or which drugs deplete it. Dr. Langsjoen is an expert on CoQ10, and his opinion makes a great deal of sense, the more you know about CoQ10 and its crucial role in energy production in all cells. Out of curiosity, what is your theory of the cause of the epidemic of heart failure?


Well, let's look at the rise in heart failures more closely. Lovastatin was approved in 1987. On the other hand, epidemiological data shows that the rising trend in incidence of heart failure in the US began rising as early as the late 70s, before statins were even on the market.

Image

So even in a simple 2+2=4 world, this ought to suggest that there are other factors at play. As for what these other factors are, without evidence I am hesistant to try and pinpoint them.


I don't know, (is this a big government/pharma graph?) And hospitalizations for what? Is that the spike in question around 1992?? When did doctors routinely move from 10 mg to 80 mgs?
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godsilove

Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#48  Post by godsilove » Sun Nov 15, 2009 7:59 am

ofonorow wrote:
Toxicity from compounds other than vitamins and minerals can also be reversible and need not be permanent. The body is capable of metabolizing and excreting many of these substances as well, and for good reason. Our diet contains millions of compounds other than nutrients, and the body needs to be able to excrete them if they are absorbed into the bloodstream.


Yes, and this supports which argument? That modern drugs are/aren't poisons?


The toxicity of drugs (modern or ancient) was never in question. The issue is whether vitamins and minerals are unequivocally safe, which they aren't.

By the way, to the extent this is true, the body can "detoxify" itself, the substance in question fits within the orthomolecular classification. What seems to be happening in pharmaceuticls is that modern biochemists are able to "adjust" natural molecules, to make them more potent or what-ever, and they become more toxic to certain people. This is why the term "bioidentical" has become popular. Same molecule, say of testosterone, that the body has evolved to make.


Many of the compounds we ingest are probably not in high enough quantities to have a pharmacologic effect. To give an example, apples contain trace amounts of cyanide - which at larger doses would be inevitably toxic, but at the tiny amounts found in foods the body is able to excrete them without much ado. With drugs, the entire purpose is to elicit a pharmacological effect - and in doing so, the chances of toxicity increases.

For these type of discussions, the basic toxicity studies are appropriate. What is the dosage that kills half the laboratory rats? As I mentioned, there are no known levels of either vitamin C or lysine that kill. I should look this up, but I believe the toxic (lethal) dosage of aspirin is less than 1 gram. Pauling spends two chapters in the book discussing this issue, and again, it is worth reading and then I would be interested in your criticism. (I don't not believe that your education opens up this alternative view of the world.) Pauling discusses one substance,ordinary aspirin and its toxicity, versus every vitamin with a toxicity concern. Night and day.


I agree that the therapeutic window for some drugs is narrow. I'm only questioning your assertion that vitamins/minerals are always safe. They aren't, as the literature clearly shows.

By the way, theLD50 for IV ascorbic acid is 518 mg kg-1 in mice. So we can surmise there is a level at which too much vitamin C can be lethal. The LD50 for oral doses is obviously higher.

Yes, and as I mentioned, I can find literature that deaths have occurred from drinking too much water. (Do we need a government agency to warn people about water ? To make sure they don't drink in excess? People are pretty smart and can figure out these differences for themselves.)


As far as vitamins and minerals are sold on their own, I've already said that I don't have a problem with the status quo. They should be freely available, but should not contain unverified marketing claims. But the P&G case is about the marketing of a vitamin in combination with a drug - it's not entirely the same thing. And I've already said that my main issue is with the marketing aspect, not the safety. Let's not juxtapose the issue of whether vitamins/minerals are perfectly safe at any dosage, and the P&G case.


How is this a preferable system? That would mean that anybody can market a concoction as a cure for cancer, and unless and until somebody else provides evidence against this, it would remain on the market.


Absolutely! The Free market, I love it! What a concept. (As you well know, unbiased, private third parties would arise to take the place of the FDA. Actually, the FDA and its "approval" haven't stopped people from migrating to alternative medicine in vast numbers... Love that Suzzane Summer's new book on Alt. Cancer treatments is a number one best seller!

p.s. if there were truly a free market, heart disease would have been abolished (cured) more than 10 years ago. Millions of people would still be living, etc. etc. etc



Speculation. An absolutely free market will not happen for a number of reasons, and these are not barriers exclusive to the healthcare industry.

I'm not sure that unbiased, private third parties would necessarily arise. You alluded to the case of Robert Fiddes earlier - and it actually points to an instance where a third party, private clinical research institute basically forged patient data for profit. The problem of course is that no one knows what an absolutely laissez-faire system would be like, since no modern country has really had one. This unfortunately allows people to make assertions based on zero real-world evidence.

The fundamental difference is that you trust pharmaceutical companies, and their well funded research, and I generally distrust them. [/color]/quote]

It's not a case of black or white. I'm not oblivious to the selective reporting, ghostwriting, methodological biases, etc that can occur in pharmaceutical research - especially when marketing people get involved. The difference is that I do not write off all this research as fraudulent and I try not to make hasty generalizations.


Good for you, but how can you decide? The obvious best studies are those not funded or supported by the interests being studied. But you cannot find these anymore, University grants come from Big Pharma, and the NIH is basically an arm of Big Pharma. For example, if a study supports some wonderful role for a statin - I simply do not believe it. However, if a Big Pharma supported study found a problem or concern about a statin - something that might cost them their share of the $20 billion market, I WOULD BELIEVE THAT STUDY :)

Whether I believe it matters not one iota, of course.



There are plenty of negative studies that are industry-supported. Don't presume that every study funded by pharma companies has a positive outcome.

As for giving the benefit of the doubt, you only have to look at the documented cases of fraud and misconduct against the number of studies which are done every year. Sure, fraud may be more common than is known, but that does not justify writing off all medical research given that much of it is legitimate.


Well, let's look at the rise in heart failures more closely. Lovastatin was approved in 1987. On the other hand, epidemiological data shows that the rising trend in incidence of heart failure in the US began rising as early as the late 70s, before statins were even on the market.

Image

So even in a simple 2+2=4 world, this ought to suggest that there are other factors at play. As for what these other factors are, without evidence I am hesistant to try and pinpoint them.


I don't know, (is this a big government/pharma graph?) And hospitalizations for what? Is that the spike in question around 1992?? When did doctors routinely move from 10 mg to 80 mgs?



Hospitalizations for heart failure - from the CDC. If you don't like it because of the source, you're welcome to pull up any other data dating back from the early 80s that shows otherwise. (The extent to which you are willing to cry foul whenever the data does support your views is baffling - why would such data would be fabricated by your government?)

In terms of the move from 10mg to 80mg, I assume you're referring to Lipitor? Lipitor was approved by the FDA in 1997, so it would be after the "spike" happened. Furthermore, the "spike" you are talking about is occuring in the 85+ age group, in which use of statins is lower than in the 65-84 yr age group. So why is there no "spike" in that group?

phughes

Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#49  Post by phughes » Sun Nov 15, 2009 10:36 am

The statement "LD50 for IV ascorbic acid is 518 mg kg-1 in mice" as a proxy for the toxicity of IV Vitamin C is meaningless since IV ascorbic acid will cause acidosis and no sane person would ever deliver IV Vitamin C as ascorbic acid.

In an IV form only sodium ascorbate makes sense. Any measurement of the LD50 for Vitamin C needs to report the LD50 for IV Sodium ascorbate.

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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#50  Post by ofonorow » Mon Nov 16, 2009 3:41 am

Good point phughes.

godsilove, please provide the link to the heart failure data at CDC. Thanks!


The issue is whether vitamins and minerals are unequivocally safe, which they aren't.


No that is not the issue, as water is not "unequivacally safe" either but no one considers regulating. The issue is perspective, so again, I cannot speak for Linus Pauling. Please take the time to read HOW TO LIVE LONGER AND FEEL BETTER - your patients and/or future patients would benefit greatly!

By the way, a thought experiment. You seem to favor government regulation, but I maintain that it is because medicine basically controls the process. I wonder if you would feel the same way if a libertarian took control of government, and put people in charge who think like I do? :) The beauty of the free market approach is no coercion. People are free to make their own decisions, with or without the help of their doctors. They decide.
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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#51  Post by Ralph Lotz » Mon Nov 16, 2009 7:43 am

Vitamin and mineral supplements thankfully have a large therapeutic window and are often available in dosages close to the RDI, i.e. the amount needed to treat deficiency. In effect, it is difficult to get a lethal overdose from them. Nonetheless, while deaths from vitamins and minerals are extremely rare, they have been reported in the literature (e.g. here and here, and here). So what you call "orthomolecular" can definitely be "deadly toxic", in addition to having non-fatal toxicities.


To discuss orthomolecular medicine it is helpful to know what the definiton is:

"Orthomolecular medicine describes the practice of preventing and treating disease by providing the body with optimal amounts of substances which are natural to the body."
http://www.orthomolecular.org/

It is also instructive to be aware of the lives and work of Roger J. Williams, Abram Hoffer and Robert Cathcart, and the reality of biochemical individuality, not once sizr fits all.

RDI is a ludicrous concept unless one is marketing TOTAL as a nutritional supplement.
"Unless we put medical freedom into the constitution...medicine will organize into an undercover dictatorship..force people who wish doctors and treatment of their own choice to submit to only what..dictating outfit offers." Dr. Benjamin Rush

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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#52  Post by ofonorow » Wed Nov 18, 2009 12:45 am

The toxicity of drugs (modern or ancient) was never in question. The issue is whether vitamins and minerals are unequivocally safe, which they aren't.


Well, we run the full circle. These substances are "unequivocally safe" enough to suit me. No one died from vitamin or mineral poisoning the last year the figures were collected. And, without much regulation, according to your side.

The number of aspirin/tylenol poisonings, to pick on one of the most popular (and studied) over the counter drugs is far above zero, from memory deaths are in the thousands. I cannot remember the liver damage numbers. These products are heavily regulated.

By the way, the issue of the negative Zetia study results has hit the news - again. (Now four years since the drug companies found out.) Why isn't our wonderful FDA protecting consumers? Obvious case of a drug that not only does not work as advertised, but has actually been found to make heart disease worsen!?
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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#53  Post by Ralph Lotz » Wed Nov 18, 2009 6:33 am

"Unless we put medical freedom into the constitution...medicine will organize into an undercover dictatorship..force people who wish doctors and treatment of their own choice to submit to only what..dictating outfit offers." Dr. Benjamin Rush

godsilove

Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#54  Post by godsilove » Wed Nov 18, 2009 5:26 pm

The link for the CDC data on heart failures:

http://www.cdc.gov/dhdsp/library/fs_heart_failure.htm


ofonorow wrote:
The toxicity of drugs (modern or ancient) was never in question. The issue is whether vitamins and minerals are unequivocally safe, which they aren't.


Well, we run the full circle. These substances are "unequivocally safe" enough to suit me. No one died from vitamin or mineral poisoning the last year the figures were collected. And, without much regulation, according to your side.

The number of aspirin/tylenol poisonings, to pick on one of the most popular (and studied) over the counter drugs is far above zero, from memory deaths are in the thousands. I cannot remember the liver damage numbers. These products are heavily regulated.

By the way, the issue of the negative Zetia study results has hit the news - again. (Now four years since the drug companies found out.) Why isn't our wonderful FDA protecting consumers? Obvious case of a drug that not only does not work as advertised, but has actually been found to make heart disease worsen!?


The mostrecent AAPCC Annual Reportactually has one reported death from Vitamin K, as well as several other documented cases due to vitamin exposure (17 with major outcomes). Just to put the high number of fatalities from all substances into perspective, 644 (52%) are suspected suicides and 138 (11%) are from drug abuse. Overall, 890 (72%) are classified as being due to intentional use, rather than dosing errors, adverse reactions, etc.

The results of the Zetia study were predicted by analysts long before they were announced. I agree that the evidence supporting its use is sparse, and the product label clearly indicates that it has only been shown to reduce LDL-C, and there is no data showing an improvement in cardiovascular outcomes - partly because the major trials so far have primarily looked at LDL as a surrogate marker for this. As a result of this, the company is not allowed to market it as a drug that reduces the risk of cardiovascular events, but is allowed to market it as a cholesterol-fighting drug. It is debatable whether the FDA should approve drugs based only on surrogate markers. A large study to demonstrate whether or not Zetia improves cardiovascular outcomes will only conclude in 2012.


By the way, a thought experiment. You seem to favor government regulation, but I maintain that it is because medicine basically controls the process. I wonder if you would feel the same way if a libertarian took control of government, and put people in charge who think like I do? :) The beauty of the free market approach is no coercion. People are free to make their own decisions, with or without the help of their doctors. They decide.


Although I can see your point, this is a slippery slope argument. We are not talking about Stalinist Russia, although if we were my perspective would be different. As I said before, the FDA is not perfect. Furthermore, I'm generally for patient freedom when it comes to making healthcare decisions; where I think regulation needs to exist is where manufacturers and marketers are concerned.

By the way, why would a libertarian put anybody in charge? :wink:

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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#55  Post by ofonorow » Thu Nov 19, 2009 4:47 am

By the way, why would a libertarian put anybody in charge? :wink:


Very good question, and although a little off topic, in my humble opinion, with the US debt and obligations now over 100 trillion, I predict a Libertarian will win. She will close all unnecessary agencies, and the FDA will be at the top of any Libertarian's list. The US will be forced to sell most Federal properties to pay off the staggering debt and avoid a US bankruptcy :lol: :lol:

http://www.telegraph.co.uk/finance/econ ... lapse.html

Back to the topic - your numbers seem fantasy to me. The reason we regulate drugs and OTC substances is because they aren't safe. We don't regulate vitamins and minerals because they are safe. Who is the extremist here?
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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#56  Post by Ralph Lotz » Thu Nov 19, 2009 6:14 am

We don't regulate vitamins and minerals because they are safe.


We do regulate vitamins and supplements in the United States very rigorously under the Dietary Supplement Health and Education Act passed in 1994 and signed by Bill Clinton.

On the subject of placing someone in charge, Libertarians are not anarchists.
http://www.lp.org/
"Unless we put medical freedom into the constitution...medicine will organize into an undercover dictatorship..force people who wish doctors and treatment of their own choice to submit to only what..dictating outfit offers." Dr. Benjamin Rush

godsilove

Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#57  Post by godsilove » Thu Nov 19, 2009 3:11 pm

ofonorow wrote:Back to the topic - your numbers seem fantasy to me.


The numbers are taken directly from the AAPCC report.

The reason we regulate drugs and OTC substances is because they aren't safe. We don't regulate vitamins and minerals because they are safe.


And the focus of this thread is an OTC product, lest we forget.


Who is the extremist here?


I don't recall using this term. :lol:

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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#58  Post by ofonorow » Fri Nov 20, 2009 5:22 am

Okay, you forced me to read/scan the AAPCC report. Very interesting, See:
http://www.aapcc.org/DNN/Portals/0/NPDS%20reports/2008%20AAPCC%20Annual%20Report.pdf

The enormous number of calls related to prescription drugs scared the heck out of me, 80,000 plus in one category alone!

Vitamin K is administered by medical doctors, to babies, as you well know. (Probably gave the wrong substance :?

And yes Ralph, supplements ARE highly regulated, but the propaganda from the other side is always that supplements are "unregulated.".. ( I was making the argument from a nutritionist point of view.)
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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#59  Post by ofonorow » Thu Nov 26, 2009 3:15 am

Won't have time to read this until next week, but will post it now for others to view (latest communique from FDA)
Dear Dr Steve Hickey,

Thank you for your message to the FDA. Your message from Chris Kelly was
forwarded to the Division of Drug Information in the Center for Drug
Evaluation and Research (CDER). The following information can be found
on the FDA warning letter to Proctor and Gamble regarding "VICKS DayQuil
Plus Vitamin C" and "VICKS NyQuil Plus Vitamin C"
(http://www.fda.gov/ICECI/EnforcementAct ... m188361.ht
m):

"In the 1976 Advance Notice of Proposed Rulemaking for OTC Cold-Cough
Drug Products, the Food and Drug Administration (FDA or agency)
published the recommendations of the Advisory Review Panel on
Over-the-Counter Cough, Cold, Allergy, Bronchodilator and Antiasthmatic
Drug Products. In those recommendations, the Advisory Review Panel
stated that they have reviewed the available data for the ingredient as
a single entity and finds that the data are insufficient to permit final
classification as safe and effective for OTC use in the prevention or
treatment of the cold.

The Panel found no study which demonstrated that vitamin C is
unequivocally effective for the prevention or treatment of the "common
cold" although some data tended to favor effectiveness for treatment of
cold symptoms. Since no conclusive data on the dose or dosage schedule
are available on vitamin C used alone or in combination products with
other ingredients for prevention or treatment of the cold, the Panel is
unable to propose adequate labeling with a dosage regimen and has
therefore classified such labeling as Category II. In summary, the Panel
has reviewed vitamin C and has classified the "ingredient" as Category
III and any "labeling" for the prevention or treatment of the cold as
Category II."

The terms "Category I," "Category II," and "Category III" are used to
describe the status of the review of the safety and effectiveness of a
particular ingredient for a particular use. "Category I" means that,
based on the data reviewed, an Advisory Review Panel and/or FDA is
proposing that the ingredient is generally recognized as safe and
effective and not misbranded; "Category II" means that the Panel and/or
FDA is proposing that the ingredient is not generally recognized as safe
and effective and is misbranded; and "Category III" means that the Panel
and/or FDA is proposing that the available data are insufficient to
classify the ingredient as safe and effective, and further testing is
required."

Additional information regarding the studies referenced in 1976 can be
found in the Advance Notice of Proposed Rulemaking for OTC Cold- Cough
Drug Products
http://www.fda.gov/downloads/Drugs/Deve ... Developmen
tResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm074781.pdf
.

Following the 1976 publication of the monograph for OTC cold, cough,
allergy, bronchodilator, and antiasthmatic (cough-cold) combination-
Vitamin C was again looked at for OTC use in the prevention or treatment
of the cold in 2002
(http://www.fda.gov/downloads/Drugs/Deve ... /Developme
ntResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm106994.pd
f). When looking at the 2002 final monograph for OTC Cold-Cough Drug
Products, one general commenter submitted published literature to
support the effectiveness of ascorbic acid to reduce the duration and
symptoms of the common cold. The commentor also submitted an unpublished
study on the preventive effects of 500mg ascorbic acid taken 4 times
daily against naturally transmitted rhinovirus 16 in college students.
The FDA determined that the submitted studies do not contain sufficient
detail to assess their value. A full report with detailed critical
appraisal of these studies were asked of the commentor; however, this
information was never provided. As such, the FDA stated that:

"The agency has determined that the submitted studies do not contain
sufficient detail to assess their value in establishing the
effectiveness of ascorbic acid in reducing the duration or symptoms of
the common cold. . .. Thus, the agency is not including ascorbic acid in
this final monograph."

Henceforth, ascorbic acid continues to be classified as a "category III
ingredient" and any labeling for prevention or treatment of cold as
category II. For copies of the mentioned studies referenced during 1976
or 2002- these are covered under the U.S. Freedom of Information Act
(FOIA). Such documents are not prepared specifically for public
distribution, but are available upon specific written request. You can
obtain a copy of the FDA publication entitled, "A Handbook for
Requesting Information and Records from FDA," which may be helpful to
you, should you decide to request this information under FOIA on this or
a future occasion. To obtain a copy of this publication please visit:
http://www.fda.gov/RegulatoryInformatio ... uest/defau
lt.htm.

Best regards,
Division of Drug Information KW
Center for Drug Evaluation and Research
Food and Drug Administration

This communication is consistent with 21CFR10.85(k) and constitutes an
informal communication that represents our best judgment at this time
but does not constitute and advisory opinion, does not necessarily
represent the formal position of the FDA, and does not bind or otherwise
obligate or commit the agency to the views expressed.
Owen R. Fonorow
HeartCURE.Info
American Scientist's Invention Could Prevent 350,000 Heart Bypass Operations a year

Johnwen
Ascorbate Wizard
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Re: What!? Are they nuts? FDA must be working for big pharma

Post Number:#60  Post by Johnwen » Thu Nov 26, 2009 9:36 am

It's safe in Europe but not in the States?????
The available human data suggest that supplemental daily doses of vitamin C up to about 1 g, in
addition to normal dietary intakes, are not associated with adverse gastrointestinal effects, but that
acute gastrointestinal effects may occur at higher intakes (3-4 g/day). The absorption of vitamin C
is saturated at high doses, and therefore intakes above 1 g/day would be associated with negligible
increased uptake and tissue levels, but an increased risk of adverse gastrointestinal effects.
The average daily intakes reported in surveys in European countries are above the recommended daily
intakes, with the 95th percentile intakes from food and supplements ranging up to about 1 g/day. These
dietary intakes do not represent a cause for concern.

Here's a link to what they did in Europe Page 297 starts V-C
http://www.efsa.europa.eu/cs/BlobServer ... inary=true
To steal ideas from one person is plagiarism. To steal from many is
research!


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