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 What!? Are they nuts? FDA must be working for big pharma 
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Vitamin C Expert
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Post Re: What!? Are they nuts? FDA must be working for big pharma
ofonorow wrote:
Quote:
So I take you would not think it is the FDA's business to prevent a company from marketing bottled water as a cure for cancer?


Are you asking my opinion whether I believe there should be an FDA? My answer is no. I believe the FDA has cost thousands if not millions of lives. (In your contrived example, you must think people are generally pretty stupid.)


The bottled water example actually isn't that far a stretch, when you look at some of the kinds of things that are sold by fraudsters as "cancer cures". I wouldn't say people are stupid, but sometimes scientifically illiterate. And if someone is dying from cancer or has a close friend or family member dying from cancer, they can be susceptible to the quacks who prey on them.

I'm glad that there is oversight here in Canada, and that people cannot claim have a product that cures cancer without documented evidence. But unfortunately people still get away with it before the law catches up with them.

Quote:
And how does the FDA, a government bureaucracy, know whether the drug works for liver cancer?


The same way the medical community "knows" whether a drug works for liver cancer - based on clinical trial data.

Quote:
And as you probably know, once a drug is approved for any purpose, a doctor in the USA can legally prescribe it for anything. (At least that is how it used to be, and I am not aware of any recent changes.)


That's true - a doctor can prescribe a drug for off-label uses, but it is illegal for companies to market their products for off-label uses.

Quote:
The discussion here is why a bureaucracy would endeavor to keep vitamin C out of cold medicines. I cannot think of any action more absurd on its face.

Quote:
If the issue was merely marketing, I would not have such a problem with this action. But I infer that the government is preventing P&G from adding vitamin C because the "combination has not been proven safe and effective." The issue is the government using force to prevent companies from adding vitamin C to cold meds, not the "marketing" of a benefit as such, even though it is crazy not to allow that. (Now I haven't watched or read the regular media for years. Has anyone seen a Vick's commercial? Are they touting any special benefit from vitamin C? I doubt it, because it wouldn't be worth the money and effort. Anyone could simply take vitamin C separately)


I agree that the "safe" part does seem a little absurd given that vitamin C's safety has been extensively studied, but the "effective" part is not a foregone conclusion, although I can understand why you would think it is. Reading the FDA's letter it seems that one of their issues is that when you combine two compounds in one formulation, the new formulation's safety and efficacy should be evaluated. Vitamin C is safe on its own, but it is possible that when combined with certain drugs, it alters the behaviour of these other drugs. For instance, it could lead a drug to stay in the bloodstream longer, thereby increasing its risks of side effects - even if vitamin C alone is safe. Now, vitamin C in combination with the drug ingredients in Nyquil may be perfectly safe, but the onus is on the company, not the FDA, to show that.

The other issue the FDA has, as I see it, is the marketing of the combination as a cold & flu medicine. If they are selling Dayquil or Nyquil plus Vitamin C in a package marked with "Cold & Flu", I would think that this constitutes marketing. Marketing isn't restricted to DTC ad campaigns on television.

Quote:
But you are comfortable with the idea of having to prove every benefit before it is allowed on the market? In this case, that argument is patently absurd. The only substance studied more than vitamin C the past century is aspirin. [/color]


I'm uncomfortable with private companies marketing products for specific indications without regulatory oversight. I think doctors should be given the freedom to prescribe drugs off-label judiciously, but I don't think companies should be able to market them for off-label uses.

Quote:
If it were a foregone conclusion that the vitamin C in Nyquil is effective, then their warning would be based on a mere technicality. But there's more to it, and it's the same legislation that aims to keep drug companies in check and ensures that snake oil salesmen don't have their way.

You focus on whether vitamin C is effective (which it is!) but why is that even an issue? Why shouldn't a private firm be entitled to add the vitamin for reasons of safety, if not efficacy reasons. It is simply nuts, and you seem quite satisfied with the nut house.


What do you mean "by reasons of safety"? I don't see why any company should add vitamin C to the product unless it is shown to be effective in what it is being marketed for. If the FDA disagrees, then the onus is on the company to provide evidence to the contrary.

Don't get me wrong, I think the FDA has plenty of problems. I just agree in principle with their raison d'etre. There ought to be oversight in order to protect consumers. Nobody likes bureaucracy, but a certain level of bureaucracy is unavoidable. It's like entering another country without a visa, and then when apprehended, saying that you have all the necessary documents to be issued a visa.

Quote:
Quote:
Who exactly do you think it is that is "exerting an influence" on the FDA?? :?:

I don't know. However, I plan to use the United States Freedom of Information Act to try and find out :lol:


When you do find out, please let us know. It could have the makings of a good spy novel. :lol:


Tue Nov 03, 2009 2:00 pm
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Vitamin C Master
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Post Re: What!? Are they nuts? FDA must be working for big pharma
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I'm not sure why you felt the need to interject your opinion on its efficacy, but at least we agree that P&G manufactures more than just personal care products.




drugs are a personal care product, taken that broadly...the majority of revenues are from non drug products

The only valid reason for attacking the vitamin c is that it isn't enough (at that dosage in the cough medicine)
I can see that, but the letter implied that C in any dosage had no effect on colds etc


Tue Nov 03, 2009 2:27 pm
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
Rather than respond to each point, let me begin with "The Road To Hell Is Paved With Good Intentions..."

No doubt your (godsilove) intentions are good, but my thoughts have been formulated, at least in part by libertarian thinkers, such as Milton Friedman and former Libertarian presidential candidate Harry Browne, who wrote the following in his 1995 book WHY GOVERNMENT DOESN'T WORK, page 109 (Chapter: Health Care - The Solution)


Quote:
1. Abolish the FDA. Let people decide for themselves, with the help of their doctors and private testing agencies they choose for themselves, which medicines are safe enough for them. Let people decide for themselves what risks they are willing to take. Let people with fatal illnesses choose any therapy they want in hope of beating the odds.
No one will be left on his own unless he wants to be. You and your doctor can use any testing and certification company you want -- including one staffed by former employees of the FDA. Let drug manufacturers prove to you and your doctor the safety of medicine - as they do now to get the FDA to act.


Private certifications! What an idea. It would be very much in an honest, quality drug manufacturers interest to have these private certifications, to set them apart from the less than reliable companies and frauds. And instead of taxpayers footing the bill - the drug companies and manufacturers would pay for the certifications.

_________________
Owen R. Fonorow, Orthomolecular Naturopath


Wed Nov 04, 2009 5:36 am
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Vitamin C Expert
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Post Re: What!? Are they nuts? FDA must be working for big pharma
ofonorow wrote:
Rather than respond to each point, let me begin with "The Road To Hell Is Paved With Good Intentions..."

No doubt your (godsilove) intentions are good, but my thoughts have been formulated, at least in part by libertarian thinkers, such as Milton Friedman and former Libertarian presidential candidate Harry Browne, who wrote the following in his 1995 book WHY GOVERNMENT DOESN'T WORK, page 109 (Chapter: Health Care - The Solution)


Quote:
1. Abolish the FDA. Let people decide for themselves, with the help of their doctors and private testing agencies they choose for themselves, which medicines are safe enough for them. Let people decide for themselves what risks they are willing to take. Let people with fatal illnesses choose any therapy they want in hope of beating the odds.
No one will be left on his own unless he wants to be. You and your doctor can use any testing and certification company you want -- including one staffed by former employees of the FDA. Let drug manufacturers prove to you and your doctor the safety of medicine - as they do now to get the FDA to act.


Private certifications! What an idea. It would be very much in an honest, quality drug manufacturers interest to have these private certifications, to set them apart from the less than reliable companies and frauds. And instead of taxpayers footing the bill - the drug companies and manufacturers would pay for the certifications.


I agree with your earlier comment that this leads into a much broader political debate. I can certainly sympathize with a libertarian point of view, and I do have libertarian leanings in certain areas.

I would have no problems with private certification if it works. Ultimately, I think there needs to be some kind of oversight. However, I don't see private certification as a perfect solution either. It would be interesting to see examples of countries that do use such a system to regulate healthcare products - I don't know of any that do. I do know that such a system is in place for certifying things like organic products and the Health Check symbol on certain processed foods. I don't know a whole lot about how effective these systems are (i.e. whether foods with the Health Check symbol are actually healthy choices), but regulating the whole panoply of drugs, medical devices, and supplements out there is a whole different ballgame. For instance, if there are multiple companies that provide such a certification, how do consumers know which one to select? And who will serve as a watchdog for these private certification companies? Who will fund these private companies - if they are for-profit, and much of their revenue comes from the companies whose products they license, wouldn't this create a conflict of interest? If some of these issues can be adequately addressed, private certification companies could effectively replace the FDA and perhaps do a more a efficient job.

I actually think establishing reputable, not-for-profit organizations to certify nutritional and herbal supplements would be a good idea, and perhaps an opportunity to see if this system could be expanded to all healthcare products. When someone walks into a health store or pharmacy, there is no way of reliably assessing the safety, efficacy, or bioequivalence of products on the shelves - at least in Canada.

But getting back to the topic of this thread, let's be clear - no patient in the United States is being deprived of the right to take as much vitamin C as they want, or to take it with Nyquil if they choose to. The government is merely denying a company's ability to market the combination as a treatment for a specific illness. From what I've seen, I don't see this as a sign of a "war on vitamin C", although you have been promoting vitamin C for quite a long time and probably have a more experienced perspective.


Wed Nov 04, 2009 1:10 pm
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
Quote:
The government is merely denying a company's ability to market the combination as a treatment for a specific illness.


Not precisely. This is because a dietary supplement was added, not Food coloring Green 49, or anything else.

And "Merely?" This (denying a company the ability to add a nutrient) is precisely the danger. This effecitvely means that no nutrient can be added to a drug without someone paying for the expensive studies needed to convince the FDA. Ergo, someone has cleverly and effectively blocked safe and effective "low cost" competition to high priced pharmaceuticals across the board.

And by the way, they are preventing the combination, aren't they? Not the marketing per se. P&G isn't marketing vitamin C as a cold medicine, it markets Vicks as a cold medicine. And per earlier communication from P&G in this topic, P&G adds it because it is known that people suffering illness are depleted of vitamin C - not as a cure.

Here are more communications from the FDA press officer, with my last letter at the bottom


Quote:
Dear Owen R. Fonorow:

Your inquiry was forwarded to the Division of Drug Information, in the
FDA's Center for Drug Evaluation and Research.

Under its over-the-counter (OTC) drug monograph system, the FDA allows
some OTC drugs to be marketed without FDA approval. Under the OTC drug
monograph review system, the FDA evaluates the active ingredients in
products after they have met certain marketing requirements to affirm
that they are safe, effective, and properly labeled for their intended
uses. This is an active ingredient review, rather than a
product-by-product (new) drug review. As a result, the FDA publishes
OTC drug monographs that list active ingredients, allowed combinations,
and required labeling for classes of OTC drug products (e.g., antacids,
cough-cold products).

An OTC drug product containing ingredients and labeling that comply with
standards established in an applicable monograph is considered to be
"generally recognized as safe and effective" (GRASE) and does not
require marketing pre-clearance by the FDA. However, OTC drugs with
active ingredient(s), dosage form, dosage strength, or route of
administration new to the OTC marketplace that do not comply with an OTC
monograph are regulated under the New Drug Application (NDA) process.
Under the NDA process, the FDA must approve the OTC drug product before
that product can be marketed. A drug manufacturer submits data in an
NDA demonstrating a drug product is safe and effective for use by
consumers without the assistance of a healthcare professional.

The two Vicks products do not comply with the applicable FDA monograph
and must first be evaluated and approved under the FDA's new drug
approval process to be legally marketed. The company must submit an NDA
to the FDA for approval prior to marketing.

In terms of what prompted these warning letters, the FDA's position on
the regulatory status of OTC drug products that combine drug ingredients
with dietary ingredients in a single dosage form has been described in
previous warning letters issued in 2001 and 2008. The agency's position
on the marketing of vitamin C for preventing or treating the common cold
also has been stated in a number of previous warning letters. You may
access FDA warning letters at
http://www.fda.gov/ICECI/EnforcementAct ... efault.htm.
You may access the Vicks warning letter at
http://www.fda.gov/ICECI/EnforcementAct ... 188361.htm
.

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

For up-to-date drug information, follow the FDA's Division of Drug
Information on Twitter: http://twitter.com/fda_drug_info


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 an 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.



________________________________

From: Kelly, Christopher
Sent: Wednesday, November 04, 2009 10:51 AM
To: CDER DRUG INFO
Cc: Poole, Barry W; Levy, Michael; Katz, Donna; Seefeld, Susan
Subject: FW: The FDA Did What? Banned Vitamin C From Cold Meds?



Good morning CDER Drug Info -



Can you please respond directly to the inquiry by Owen R. Fonorow,
thanks!



Chris Kelly





Christopher C. Kelly
Press Officer
U.S. Food and Drug Administration
(301) 796-4676
(240) 753-8610 (cell)
christopher.kelly@fda.hhs.gov


Quote:
Dear Susan Seefeld,


Thank you for the press release, but it doesn't really help my confusion.

The recent FDA action makes little sense to a reasonable person. Why is the Federal government pursing such a foolish policy? No dietary supplement or drug has been studied more than vitamin C since the 1930s, with the possible exception of aspirin.

It is quite easy for ordinary people to easily assess vitamin C's remarkable effectiveness against colds and the flu for themselves; the amazing effect is proportional to the dosage. And because the effect is unmistakable, this action by the FDA seems absurd, and makes the public at large skeptical of the so-called science and government agencies.

As far as recent science, please review the following in MEDLINE, one of the few studies run with a proper dosage, and perhaps the only recent study:

The effectiveness of vitamin C in preventing and relieving the symptoms
of virus-induced respiratory infections.

<http://www.ncbi.nlm.nih.gov/pubmed/10543583?itool=EntrezSystem2.PEntrez
.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=3>

Gorton HC, Jarvis K.

J Manipulative Physiol There. 1999 Oct;22(8):530-3.PMID: 10543583
[PubMed - indexed for MEDLINE]

http://www.ncbi.nlm.nih.gov/sites/entre ... Med&term=T
he%20effectiveness%20of%20vitamin%20C%20in%20preventing%20and%20relievin
g%20the%20symptoms%20of%20virus-induced%20respiratory%20infection&cmd=se
arch&cmd_current=

RESULTS: Overall, reported flu and cold symptoms in the test group
decreased 85% compared with the control group after the administration
of megadose Vitamin C. CONCLUSION: Vitamin C in megadoses administered
before or after the appearance of cold and flu symptoms relieved and
prevented the symptoms in the test population compared with the control
group.


We at the Vitamin C Foundation are interested in what prompted this warning letter to Proctor and Gamble. Who or what entity initiated this action? Specifically, was anyone outside the agency involved? And if so, who? Thank you for any help in this regard.

Sincerely,

Owen R. Fonorow

VitaminCFoundation.org





_________________
Owen R. Fonorow, Orthomolecular Naturopath


Thu Nov 05, 2009 4:16 am
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Vitamin C Expert
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Post Re: What!? Are they nuts? FDA must be working for big pharma
ofonorow wrote:
Quote:
The government is merely denying a company's ability to market the combination as a treatment for a specific illness.


[color=#000080]Not precisely. This is because a dietary supplement was added, not Food coloring Green 49, or anything else.

And "Merely?" This (denying a company the ability to add a nutrient) is precisely the danger. This effecitvely means that no nutrient can be added to a drug without someone paying for the expensive studies needed to convince the FDA.


I don't see why nutrients as a whole should be exempt, and this is not a dangerous precedent vis-a-vis dietary supplements. Vitamins and other dietary supplements are active compounds which have a pharmacological effect, thus there is always the potential for drug interactions. For example, iron is a "nutrient" but is know to have interactions with a number of drugs.

And studies that would be needed to prove the safety of the combination would not have to be expensive trials in hundreds of patients. I would think that a few animal studies as well as Phase I studies in a few healthy humans to show the pharmacokinetics would be sufficient. Vitamin C is already on the FDA's GRAS list, so P&G probably would have to show that vitamin C does not have any potentially harmful interactions with acetaminophen, dextromethorphan, and doxylamine.

Quote:
Ergo, someone has cleverly and effectively blocked safe and effective "low cost" competition to high priced pharmaceuticals across the board.


I fail to see the connection here. Vitamin C as a supplement is widely available for dirt cheap. Surveys show that it is one of the most (if not the most) widely used supplements. How much does a pack of Vicks Nyquil + Vitamin C cost compared to generic vitamin C capsules? The FDA's warning letter to P&G will not affect the sale of vitamin C, only of Vicks Nyquil + Vitamin C. Perhaps a competitor of Vicks Nyquil tipped off the FDA, but unless Vicks Nyquil + Vitamin C was eating up a signficant market share, I don't see this as likely. In any case, this decision will not affect "high priced pharmaceuticals across the board". How could it, unless Vicks Nyquil competes with every blockbuster drug?

Quote:
And by the way, they are preventing the combination, aren't they? Not the marketing per se. P&G isn't marketing vitamin C as a cold medicine, it markets Vicks as a cold medicine. And per earlier communication from P&G in this topic, P&G adds it because it is known that people suffering illness are depleted of vitamin C - not as a cure.


Vicks Nyquil + Vitamin C is marketed as a cold medicine. Whatever the reason may be for adding vitamin C, the labelling on the package can lead to confusion. Without the appropriate information on the label, consumers would be led to believe that the Vitamin C is meant to treat colds.


I notice in your letter to the FDA, you mention that large doses of vitamin C are required to see a benefit. According to Vicks' website, Nyquil plus Vitamin C contains 200mg of vitamin C in two caplets (which if taken every 6 hours, is 800mg per day). Now, if this dosage - by the foundation's own admission - is not optimal for treating colds, then the FDA is correct in saying that the combination marketed by P&G has not been shown to be effective.


Thu Nov 05, 2009 1:28 pm
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Post Re: What!? Are they nuts? FDA must be working for big pharma
By the way, do you have a copy of the paper referenced in your letter to the FDA? I'm curious to see how they determined that "reported flu and cold symptoms in the test group
decreased 85% compared with the control group". How was a decrease measured?


Thu Nov 05, 2009 1:52 pm
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
Here is the link to that abstract: http://www.ncbi.nlm.nih.gov/sites/entre ... d_current=

Your argument is applying laws that are designed to regulate toxic drugs - substances generally foreign to the human body - to nutrients, substances that are generally well known, even required for life. (And yes almost all minerals are toxic at some dosage, and almost all vitamins are not toxic at almost any dosage.)

The point of the 1994 DSHEA act was to tell the FDA that it is generally ridiculous to regulate most dietary supplements in the same way the FDA regulates drugs. The law says basically that the FDA should behave itself and focus on its primary objective - keeping the public safe from toxic drugs.

But they cannot help themselves, why? Has any person been poisoned by a vitamin lately? (Answer: No, see: http://orthomolecular.org/resources/omns/v05n04.shtml ) Has Vicks/Dayquill harmed anyone lately? So why the concern over vitamin C when 100,000s or more Americans are being maimed or killed by FDA approved drugs?

and a p.s. I was thinking of adding CoQ10 to statin drugs, per the Merck patents. Under current FDA regulation, Merck would have to run extensive studies to "prove" to the FDA that the combination of a statin and CoQ10 is safe and effective. Meanwhile the incidence of heart failure leading to heart transplant has tripled since the dosages of statin drugs prescribed has increased.

Anticipating a question, here are some web references to the "epidemic" of heart failure:

http://www.dogpile.com/dogpile_toolbar/ ... rt+failure

http://articles.mercola.com/sites/artic ... demic.aspx

So while this may be good for the finances of cardiologists and heart transplant surgeons, it is not really great for heart patients or the public.

_________________
Owen R. Fonorow, Orthomolecular Naturopath


Fri Nov 06, 2009 4:09 am
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Post Re: What!? Are they nuts? FDA must be working for big pharma
godsilove wrote:
I don't see why nutrients as a whole should be exempt, and this is not a dangerous precedent vis-a-vis dietary supplements. Vitamins and other dietary supplements are active compounds which have a pharmacological effect, thus there is always the potential for drug interactions. For example, iron is a "nutrient" but is know(n) to have interactions with a number of drugs.

And studies that would be needed to prove the safety of the combination...

Sir/Madam, I don't see why you don't see why. ;)

Your quote above is the best example of nutriphobia I've seen yet; a great example of the second of 2 conditions that wellness warrior and radio show host Dave Stouder intends to cure. These conditions are:
1. Mediphilia: "A syndrome in which someone believes that drugs will make you healthy."

2. Nutriphobia: "A condition where otherwise sensible people think that drugs are safe and nutritional supplements are dangerous."
------------

Health Warrior radio show

A. Does Exercise Interfere With Cigarette Smoking?

Download
http://www.thehealthwarrior.net/mp3/THW%207-27-08.mp3

Play (streaming audio, Posted on 2008-07-27)
http://www.thehealthwarrior.net/listen.php?page=5#play
------------

B. Nutriphobia: Underdiagnosed Health Problem?

Download
http://www.thehealthwarrior.net/mp3/THW-3-23-08.mp3

(the most relevant part starts at 8 min:18 sec)

Play (streaming audio, Posted on 2008-03-23)
http://www.thehealthwarrior.net/listen.php?page=6#play
------------

C. Pay No Attention To That Drug Company Behind The Curtain

Download
http://www.thehealthwarrior.net/mp3/THW-4-05-09.mp3

Play (streaming audio, Posted on 2009-04-05)
http://www.thehealthwarrior.net/listen.php#play


Sat Nov 07, 2009 10:37 am
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Post Re: What!? Are they nuts? FDA must be working for big pharma
VanCanada wrote:
godsilove wrote:
I don't see why nutrients as a whole should be exempt, and this is not a dangerous precedent vis-a-vis dietary supplements. Vitamins and other dietary supplements are active compounds which have a pharmacological effect, thus there is always the potential for drug interactions. For example, iron is a "nutrient" but is know(n) to have interactions with a number of drugs.

And studies that would be needed to prove the safety of the combination...

Sir/Madam, I don't see why you don't see why. ;)

Your quote above is the best example of nutriphobia I've seen yet; a great example of the second of 2 conditions that wellness warrior and radio show host Dave Stouder intends to cure. These conditions are:
1. Mediphilia: "A syndrome in which someone believes that drugs will make you healthy."

2. Nutriphobia: "A condition where otherwise sensible people think that drugs are safe and nutritional supplements are dangerous."
------------

Health Warrior radio show

A. Does Exercise Interfere With Cigarette Smoking?

Download
http://www.thehealthwarrior.net/mp3/THW%207-27-08.mp3

Play (streaming audio, Posted on 2008-07-27)
http://www.thehealthwarrior.net/listen.php?page=5#play
------------

B. Nutriphobia: Underdiagnosed Health Problem?

Download
http://www.thehealthwarrior.net/mp3/THW-3-23-08.mp3

(the most relevant part starts at 8 min:18 sec)

Play (streaming audio, Posted on 2008-03-23)
http://www.thehealthwarrior.net/listen.php?page=6#play
------------

C. Pay No Attention To That Drug Company Behind The Curtain

Download
http://www.thehealthwarrior.net/mp3/THW-4-05-09.mp3

Play (streaming audio, Posted on 2009-04-05)
http://www.thehealthwarrior.net/listen.php#play


You misconstrue my views. I recognize that most drugs have safety and tolerability issues, and I generally advocate considering a medication's risk-benefit profile. I also recognize that some of the drugs available on the market are not always effective, and sometimes can have risks that outweight any benefit.

As for nutritional supplements...do I believe that they are all dangerous? No, but I do recognize that they can be if used inappropriately. For what it's worth, I take Vitamin D supplements in the winter, so I'm not exactly averse to the use of supplements. The definition of "nutriphobia" includes blanket statements that don't accurately reflect my opinions. Different compounds have different pharmacological effects, and thus varying efficacy and tolerability. I support the use of nutritional supplements for uses that are evidence-based, and if you read my previous posts on this forum, you'll see that I repeatedly cite the need for high quality clinical studies to elucidate their benefits. I just don't buy into the idea that vitamins are a panacea. I also think that uniformly categorizing micronutrients as "safe" and drugs as "toxic" creates a false distinction. Yes, for the most part micronutrients are safer than drugs - but certain micronutrients can also have toxic effects, either on their own or in the presence of other compounds.

I hope you don't think that micronutrients are universally safe at any dosage.


Sat Nov 07, 2009 4:16 pm
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Post Re: What!? Are they nuts? FDA must be working for big pharma
ofonorow wrote:
Here is the link to that abstract: http://www.ncbi.nlm.nih.gov/sites/entre ... d_current=

Your argument is applying laws that are designed to regulate toxic drugs - substances generally foreign to the human body - to nutrients, substances that are generally well known, even required for life. (And yes almost all minerals are toxic at some dosage, and almost all vitamins are not toxic at almost any dosage.)


Why are we shifting goalposts? Minerals are considered as nutrients, and so I stand by my original assertion that the sale of nutrients should also be regulated. I'm not saying that they should be regulated in exactly the same way as synthetic drug molecules, but that they should not be exempt from regulation entirely. Since you at least acknowledge that minerals can be toxic at certain dosages, I hope you can understand my reasoning as to why companies should not be allowed to combine them with their drug products without prior approval. Nonetheless, your statement that "almost all vitamins are not toxic at almost any dosage" is not true, although I suppose that depends on how liberally you define "almost all" and "almost any".

Quote:
The point of the 1994 DSHEA act was to tell the FDA that it is generally ridiculous to regulate most dietary supplements in the same way the FDA regulates drugs. The law says basically that the FDA should behave itself and focus on its primary objective - keeping the public safe from toxic drugs.


But this is not exactly the same thing; we're talking about the use of vitamin C in combination with synthetic drug molecules, which is very much under the FDA's jurisdiction.

Furthermore, the safety issue is just one component of the FDA's warning letter. The other involves the marketing aspect, and in this case the DSHEA prohibits manufacturers from making claims about prevention or treatment of specific illnesses without prior approval.

Quote:
But they cannot help themselves, why? Has any person been poisoned by a vitamin lately? (Answer: No, see: http://orthomolecular.org/resources/omns/v05n04.shtml ) Has Vicks/Dayquill harmed anyone lately? So why the concern over vitamin C when 100,000s or more Americans are being maimed or killed by FDA approved drugs?


Well, if the safety issue were the only thing at stake, I agree it would seem petty. But I see this primarily as an issue with how health products are marketed, and while I agree that there are probably more important issues that the FDA as a whole needs to deal with, this is coming from a division that regulates OTC products and not prescription products. It's a bit like arguing whether a police officer should ticket someone for jaywalking when (s)he could be doing something else instead.

And the issue about FDA approved drugs that are demonstrably a lot more dangerous is a red herring, considering that some of these drugs are intended to treat more severe conditions. And the argument here isn't whether the FDA has done a stellar job in other areas, which it clearly hasn't.

Quote:
and a p.s. I was thinking of adding CoQ10 to statin drugs, per the Merck patents. Under current FDA regulation, Merck would have to run extensive studies to "prove" to the FDA that the combination of a statin and CoQ10 is safe and effective. Meanwhile the incidence of heart failure leading to heart transplant has tripled since the dosages of statin drugs prescribed has increased.

Anticipating a question, here are some web references to the "epidemic" of heart failure:

http://www.dogpile.com/dogpile_toolbar/ ... rt+failure

http://articles.mercola.com/sites/artic ... demic.aspx

So while this may be good for the finances of cardiologists and heart transplant surgeons, it is not really great for heart patients or the public.


I don't see why Merck shouldn't have to prove the safety and efficacy if it chose to market a combination of a statin and CoQ10. Given the way pharmaceutical marketers operate, they would re-brand the drug and sell this "new, improved" version at a premium. It's only fair that they demonstrate that it is in fact an improved formulation or that it does what it claims to do on the label. For example, if Merck claims that the formulation treats CoQ10 deficiency induced by statins, then they should have studies that show that the dose of CoQ10 in the formulation does in fact do this and to what extent. If Merck claims it this will reduce the incidence of statin-related side effects, then they should have studies showing this. After all, it's not a given that CoQ10 supplementation reduces the incidence of statin side effects.

If pharmaceutical companies could create new drug formulations simply by adding a vitamin and without having to go through any approval process, it would be quite a bonus for them and would not necessarily help consumers. Okay, with prescription products they probably would need data to convince doctors to use them but with OTC products, that's less of an issue.

By the way, are you suggesting that the increase in the incidence of heart failure is causally linked to an increase in the use of statins? I don't see any evidence of this in the links you provided. A lot has changed since statins first appeared on the market; the rate of obesity has also increased, but it would be a bit absurd to blame statins for that. I don't know why the rate of heart failures has increased, but I would be cautious about blaming something without concrete evidence.


Sat Nov 07, 2009 7:15 pm
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
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so I stand by my original assertion that the sale of nutrients should also be regulated


Then water should be regulated. You are arguing rotten apples and stale oranges. Its the old discussion of what makes a substance orthomolecular (versus a toximolecular) drug. Yes, minerals, and some vitamins can become toxic, but minerals are substances required for life, and the misery associated with them is usually caused by too little, not too much. And where is the evidence that orthomolecular substances cause any harm what-so-ever?

And maybe the drugs are intended for more severe disease, okay, but what about the thousands of people harmed by NSAIDS every year? The number of livers lost? And we (Foundation) have been "prescribing" (recommending) vitamin C and lysine since around 1994 for heart disease!!

Sure, anyone in the medical profession would prefer that "unregulated" vitamins be regulated. It is in their (your?) interest, because regulation reduces competition. People can take vitamins without having to see a doctor or get a prescription.

As far as adding Coq10 to statin drugs (one example) it should be a business decision, not a bureaucratic government decision; i.e., a decision heavily influenced by special interests, clearly not the public interest.

Finally, I suppose it is merely a "theory" that statins are leading to ever increasing rates of heart failure, but this theory was proposed by a practicing cardiologist who is also a world-expert in CoQ10, Peter H. Langsjoen, MD (An associate of Carl Folkers, the Merck scientist who first isolated CoQ10)
According to Dr. Langsjoen,

Quote:
"n my practice of 17 years in Tyler, Texas, I have seen a frightening increase in heart failure secondary to statin usage, �statin cardiomyopathy.� Over the past five years, statins have become more potent, are being prescribed in higher dosages, and are being used with reckless abandon in the elderly and in patients with �normal� cholesterol levels. We are in the midst of a Congestive Heart Failure epidemic in the US with a dramatic increase over the past decade. Are we causing this epidemic through our zealous use of statins? In large part I think the answer is yes.

"We are now in a position to witness the unfolding of the greatest medical tragedy of all time - never before in history has the medical establishment knowingly created a life threatening nutrient deficiency in millions of otherwise healthy people."

_________________
Owen R. Fonorow, Orthomolecular Naturopath


Sun Nov 08, 2009 5:50 am
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Vitamin C Expert
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Post Re: What!? Are they nuts? FDA must be working for big pharma
ofonorow wrote:
Quote:
so I stand by my original assertion that the sale of nutrients should also be regulated


Then water should be regulated.


Yes, but only in the sense that nobody should be allowed to sell it with a claim that it will cure cancer.

Quote:
You are arguing rotten apples and stale oranges. Its the old discussion of what makes a substance orthomolecular (versus a toximolecular) drug. Yes, minerals, and some vitamins can become toxic, but minerals are substances required for life, and the misery associated with them is usually caused by too little, not too much. And where is the evidence that orthomolecular substances cause any harm what-so-ever?


Those terms try to create a distinction that is often blurred in nature. Various vitamins and minerals can have side effects at certain doses, for instance Vitamins A and E and minerals like iron. The basic pharmacological priniciple of "the dose makes the poison" applies to most things you call "orthomolecular" just as it does to other molecules.

Furthermore, part of the question here is of the safety of vitamins combined with certain drugs. Just because a compound is safe on its own, does not mean it cannot lead to potentially adverse effects when combined with another. The other issue here is marketing vitamin C for a specific condition, in this case colds and flu, which P&G is not allowed to do. If the Foundation believes that the evidence is sufficient, then I look forward to seeing your correspondence with the FDA in this regard.

Quote:
And maybe the drugs are intended for more severe disease, okay, but what about the thousands of people harmed by NSAIDS every year? The number of livers lost? And we (Foundation) have been "prescribing" (recommending) vitamin C and lysine since around 1994 for heart disease!!


This is a tu quoque argument. If you think the FDA could be doing a better job vis-a-vis NSAIDs, then that's a different issue altogether. However, being lenient towards companies that illegally market cold medicines will not solve it.

Quote:
Sure, anyone in the medical profession would prefer that "unregulated" vitamins be regulated. It is in their (your?) interest, because regulation reduces competition. People can take vitamins without having to see a doctor or get a prescription.


I'm not advocating turning all vitamins into prescription products, and I'm not sure where you got that idea from. The status quo regarding the availability of vitamin and mineral supplements is fine, as is the FDA's oversight over how they are marketed. Believe me, it wouldn't be in my interest to have to see a doctor every time I want to replenish my supply of vitamin D. But if I walk into a pharmacy and see a bottle of Vitamin D claiming on the label that it prevents a specific illness, I'd want there to be a system in place that ensures that the manufacturer was able to make that claim based on sufficient evidence.

Furthermore, your point about the medical profession's fear of unregulated vitamins is unfounded. In fact, even as we speak, vitamins are widely available in stores and anyone can buy them. There's plenty of information and misinformation on the internet regarding the benefits of vitamins, yet the medical profession thus far has not become obsolete. And maybe the doctors you've come across have all been greedy and selfish, but to portray an entire profession in this light is just incorrect.

Quote:
As far as adding Coq10 to statin drugs (one example) it should be a business decision, not a bureaucratic government decision; i.e., a decision heavily influenced by special interests, clearly not the public interest.


Is the implication here that business decisions are in the public interest?

And yes, adding CoQ10 to statins is a business decision and I would presume that Merck for whatever reason decided not to go down that path.

Quote:
Finally, I suppose it is merely a "theory" that statins are leading to ever increasing rates of heart failure, but this theory was proposed by a practicing cardiologist who is also a world-expert in CoQ10, Peter H. Langsjoen, MD (An associate of Carl Folkers, the Merck scientist who first isolated CoQ10)
According to Dr. Langsjoen,
Quote:
"n my practice of 17 years in Tyler, Texas, I have seen a frightening increase in heart failure secondary to statin usage, �statin cardiomyopathy.� Over the past five years, statins have become more potent, are being prescribed in higher dosages, and are being used with reckless abandon in the elderly and in patients with �normal� cholesterol levels. We are in the midst of a Congestive Heart Failure epidemic in the US with a dramatic increase over the past decade. Are we causing this epidemic through our zealous use of statins? In large part I think the answer is yes.

"We are now in a position to witness the unfolding of the greatest medical tragedy of all time - never before in history has the medical establishment knowingly created a life threatening nutrient deficiency in millions of otherwise healthy people."


You've posted this before, but Dr Langsjoen does not cite any strong evidence to support his claims (a single-institution observation cannot be extrapolated to an entire country). He may be an expert on CoQ10, but that alone does not make his opinions fact.


Mon Nov 09, 2009 1:39 pm
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Ascorbate Wizard
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Post Re: What!? Are they nuts? FDA must be working for big pharma
Stimulating as usual!

Quote:
Those terms try to create a distinction that is often blurred in nature. Various vitamins and minerals can have side effects at certain doses, for instance Vitamins A and E and minerals like iron. The basic pharmacological priniciple of "the dose makes the poison" applies to most things you call "orthomolecular" just as it does to other molecules.


Absolutely not! (We would be less at odds if you would simply take the time to read Pauling's book HOW TO LIVE LONGER AND FEEL BETTER. :) )

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.

On the other hand, most drugs, even OTC drugs (such as NSAIDS) are poisons, and relatively tiny dosages can easily kill, as proven by the numbers.

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.


Quote:

Furthermore, part of the question here is of the safety of vitamins combined with certain drugs. Just because a compound is safe on its own, does not mean it cannot lead to potentially adverse effects when combined with another. The other issue here is marketing vitamin C for a specific condition, in this case colds and flu, which P&G is not allowed to do. If the Foundation believes that the evidence is sufficient, then I look forward to seeing your correspondence with the FDA in this regard.



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...)

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!

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.)

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


Quote:
Furthermore, your point about the medical profession's fear of unregulated vitamins is unfounded. In fact, even as we speak, vitamins are widely available in stores and anyone can buy them. There's plenty of information and misinformation on the internet regarding the benefits of vitamins, yet the medical profession thus far has not become obsolete. And maybe the doctors you've come across have all been greedy and selfish, but to portray an entire profession in this light is just incorrect.


Actually, some of my personal heroes and great friends are doctors - alternative or chelation doctors.

Quote:
Quote:
Quote:
"n my practice of 17 years in Tyler, Texas, I have seen a frightening increase in heart failure secondary to statin usage, �statin cardiomyopathy.� Over the past five years, statins have become more potent, are being prescribed in higher dosages, and are being used with reckless abandon in the elderly and in patients with �normal� cholesterol levels. We are in the midst of a Congestive Heart Failure epidemic in the US with a dramatic increase over the past decade. Are we causing this epidemic through our zealous use of statins? In large part I think the answer is yes.

"We are now in a position to witness the unfolding of the greatest medical tragedy of all time - never before in history has the medical establishment knowingly created a life threatening nutrient deficiency in millions of otherwise healthy people."


You've posted this before, but Dr Langsjoen does not cite any strong evidence to support his claims (a single-institution observation cannot be extrapolated to an entire country). He may be an expert on CoQ10, but that alone does not make his opinions fact.


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?

_________________
Owen R. Fonorow, Orthomolecular Naturopath


Tue Nov 10, 2009 4:18 am
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Vitamin C Master
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Post Re: What!? Are they nuts? FDA must be working for big pharma
Quote:

Anticipating a question, here are some web references to the "epidemic" of heart failure:

http://www.dogpile.com/dogpile_toolbar/ ... rt+failure

http://articles.mercola.com/sites/artic ... demic.aspx

So while this may be good for the finances of cardiologists and heart transplant surgeons, it is not really great for heart patients or the public.
[/color]
[/quote]


last I read,death by heart disease was down, but you are saying that heart failure is up?


Wed Nov 11, 2009 2:22 pm
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