The FDA is targeting vitamin C: the agency has banned commercial vitamin C products for injection without reports of adverse effects. the unintended consequence of this federal action may vastly improve the efficacy of intravenous vitamin C in alternative practice.
An Opinion Part 1
Vitamin C (as sodium ascorbate) is the safest substance that can be injected into the human body, yet the US Food and Drug Administration (FDA) has declared it public enemy number 1. Vitamin C, unlike salt (saline) or sugar (dextrose), when consumed has no known toxic or lethal dose. Vitamin C in the form of sodium ascorbate has been routinely used intravenously around the world since the 1940s. Sodium ascorbate when added to water is bactericidal.(1) Thus, vitamin C as sodium ascorbate is even safer than water for injection. Vitamin C has even been used as a placebo in studies of intravenous edetate disodium (EDTA) recently published by the Journal of the American Medical Association (JAMA).(2), (3) None of these facts have deterred the "public servants" at the FDA from attacking vitamin C without cause. If there have been complaints or issues, these complaints have not yet been made public. The FDA now classifies vitamin C for injection as an "unapproved drug." By taking this action, the FDA has effectively removed commercial vitamin C products intended for injection from the market, and at least one major clinical cancer trial of intravenous vitamin C has been suspended.(4)
Yet all may not be lost. The Vitamin C Foundation, a 501(c) (3) nonprofit organization, retained famed FDA attorney Jonathan Emord. In the opinion of Emord and Associates, "Vitamin C for intravenous administration is still readily available to patients acting through compounding pharmacies, provided the patients obtain treatment through their physician." Emord explains that the FDA, a federal agency, cannot regulate the practice of medicine.
Legally, physicians have at least two options: Physicians can write a prescription for a compounding pharmacy, or licensed physicians are free to mix their own sodium ascorbate for intravenous administration. The late Robert F. Cathcart III, MD, mixed his own solutions and recommended this approach to other physicians.(5)
The evidence that we present here makes a strong case that not all vitamin C infusions are created equal. We review experimental evidence and present an important anecdotal case report which illustrates that intravenous sodium ascorbate (IV/C) produced according to Cathcart's specifications is superior to those solutions sold commercially. Our opinion has been formed for reasons of chemistry; vitamin C is volatile and quickly breaks down into dehydroascorbic acid and other factors in water. We now believe that Carthcart's IV/Cs are perhaps twice as potent as the now outlawed commercial IV/C solutions. Although solutions for IV from a compounding pharmacy may be better than the commercial vials, they too are forced to suffer from a "quirk" in the US Pharmacopeia (USP). Cathcart noted that the USP requires the mixture to begin as ascorbic acid, and then buffered. Cathcart's method starts with sodium ascorbate, a nonacidic (already buffered) form of vitamin C.
Frederick Kienner, MD, Yesterday and the FDA Today
The safety and efficacy of intravenous vitamin C as sodium ascorbate has been proved over a long history of intravenous use. Frederick Klenner, MD, pioneered the use of intravenous vitamin C in his practice.(6) He was also the first to publish a report on its use and effectiveness for treating otherwise intractable polio patients at a 1949 meeting of the American Medical Assocation (AMA).(7)
Here is the abstract of his remarks as recorded in JAMA:
Dr. F. R. Klenner, Reidsville, North Carolina: It might be interesting to learn how poliomyelitis was treated in Reidsville, NC, during the 1948 epidemic. In the past seven years, virus infections have been treated and cured in a period of seventy-two hours by the employment of massive frequent injections of ascorbic acid, or vitamin C. I believe that if vitamin C in these massive doses--6,000 to 20,000 mg in a twenty-four hour period--is given to these patients with poliomyelitis none will be paralyzed and there will be no further maiming or epidemics of poliomyelitis.(8)
All his polio patients recovered without the debilitating aftereffects that are common among polio survivors.
Vitamin C expert and author Thomas E. Levy, MD, JD, has cataloged more than 1200 studies on the effectiveness of intravenous vitamin C in the treatment, even cure of infectious disease, especially viral infections. Dr. Levy has done a remarkable job of reviewing and clearly presenting all this evidence in his recent book Curing the Incurable: Vitamin C, Infectious Diseases and Toxins.(9) Many of these peer-reviewed clinical studies are not readily available and require access to a good medical library because they are too old to be cataloged in today's modern Pubmed/Medline online databases maintained by the National Institutes of Health (NIH).
Surprisingly, on October 9, 2009, the FDA warned Proctor & Gamble that it was acting illegally. P&G has vitamin C on the labels of over-the-counter (OTC) children's cold medications.(10) Then on Dec 28, 2010, the FDA sent a warning letter to McGuff Pharmaceuticals implying that the sale of McGuff's vitamin C for injection amounted to the sale of an "unapproved drug."(11) McGuff has since discontinued the mass production of vitamin C vials for injection, and the FDA action has caused the suspension of several trials evaluating the efficacy of IV/C.
The Vitamin C Foundation's mission is to publish accurate scientific information about vitamin C. We try to faithfully follow in the footsteps of Linus Pauling. We know that, in stark contrast to the OTC and prescription drugs regulated by the FDA, there have been no reported deaths from any vitamin, mineral, amino acid or herb, maybe ever, but surely this has been true for at least a decade. The Orthomolecular News Service latest report found zero deaths from any dietary supplement in 2009.(12) (See article, p. 18.) The foundation's members believe that most human ailments are amenable to vitamin C treatment, and that a wide assortment of ailments would not exist in the first place if human livers were capable of a transformation common in other species: turning glucose into vitamin C.(13) A recent case report of a man in a coma about to lose his life after almost succumbing to the swine flu has been documented on the New Zealand version of 60 Minutes.(14) This case reminds us that intravenous vitamin C has miraculous effects against viral infections at the proper dosage and frequency.
Given the long track record of safety and efficacy, one wonders: why has the FDA suddenly taken aim at vitamin C? IV/C cannot be compared to dangerous anti-AIDS drugs, which really can be held up as examples of what a "new drug" is, and why they should be subjected to rigorous testing before approval. Therefore, it is reasonable to assume that this agency must have been flooded with consumer complaints.(15) Unfortunately the FDA MedWatch database is not available online. We have called the FDA, and the bureaucrats aren't talking. They told us that they don't know if there have been any complaints. It is possible that something may have happened at a clinical trial that prompted this action by the FDA. At the time of this writing (February 2011), we have not been made aware of a single consumer complaint or any reported adverse reactions.
We think it is fair to ask, who are these FDA bureaucrats really working for? Why would the US government bother to expend its resources and try and make vitamin C more expensive and harder to obtain for IV?(16) How is this action, even if strictly legal, a good use of scarce public resources, much less promoting public health and welfare? Is it really worth interrupting important clinical trials of IV/C for cancer?
Apparently, halting the cancer trials is the most obvious hidden agenda behind the FDA's sudden interest in going after vitamin C. Physicians all over the country are already using intravenous vitamin C as a chemotherapeutic cancer agent. These clinics are having good results, and they are getting local and even some national press coverage. This renewed interest in vitamin C for cancer has been fueled by Mark Levine's work at the National Institutes of Health.(17) As Pauling foretold, vitamin C is a life-giving nutrient that is essential in very tiny amounts. However, something miraculous happens when larger "orthomolecular" dosages are given. Orthomolecular "vitamin" C has the potential to bankrupt the pharmaceutical industry--the very industry that the FDA is supposed to be regulating, not protecting. The so-called cancer industry is particularly protective of its high profit margins.(18)
Analysis: FDA Warns Proctor & Gamble That It Is Illegal to List Vitamin C on Its OTC Cold Medication Labels
We were caught by surprise when the FDA issued its warning letter to Proctor & Gamble about vitamin C in its cold medications for children. A reasonable person might hope that our public servants would be genuinely concerned about sick children and their frantic parents. You don't have to be a vitamin C expert to know that kids need more vitamin C when they are sick and parents should be advised that all children with colds and the flu should take more vitamin C (and vitamin D3).(19) Rather than advocating vitamin C for sick children, the FDA bureaucrats were doing the opposite. They were essentially telling companies not to use vitamin C in their OTC cold medications. Why? A dedicated public servant at the FDA had apparently noticed that vitamin C when combined with OTC ingredients was "unapproved."
Why would the US government take this action, and who are the people in the FDA behind it? What danger was this agency protecting us from? In February 2010, we filed our first Freedom of Information Act Request (FOIA) with the FDA under the auspices of the Vitamin C Foundation. We sought information about the basis for the Proctor & Gamble warning letter. We specifically asked about a supposed "panel of experts" that figured prominently in the FDA letter. Surely members of this panel were behind this action. Approximately 6 months later, in July 2010, I (Owen) was contacted by an FDA attorney and told that the FDA panel mentioned in the letter had convened in the 1970s. He then asked me whether we really wanted the FDA to dig into the information about that panel, etc.(20) He then told me during the same conversation that the FDA has a large number of FOIA requests, and that all requests are handled first-in, first-out. The FDA was currently processing FOIA requests from 2007 or 2008.
Meanwhile, a class action suit had been started in Ohio against Proctor & Gamble based on the FDA warning letter--and the case had already been decided in an Ohio court.(21) Proctor & Gamble prevailed, long before we had any response whatsoever from the FDA about our FOIA request. According to an interpretation of the ruling by the legal firm Shook, Hardy and Bacon, the Ohio decision is significant because it demonstrates the limitations of FDA warning letters in the courts.
Determining whether the plaintiffs had stated a claim upon which relief could be granted, the court emphasized that nothing in the warning letter or the complaint suggested that "the addition of vitamin C renders the other ingredients in the products literally ineffective as 'pain reliever/fever reducer, cough suppressant, nasal decongestant, and antihistamine."
Analysis: FDA Warning Letter to McGuff That Vitamin C Is Not an 'Approved Drug' Throws the Status of IV/C into Question.
The December 28, 2010, FDA letter to McGuff Pharmaceuticals made the following assertions in the section Unapproved New Drug and Misbranding Violation:
In addition to violating CGMPs, you manufacture and market unapproved new drugs in violation of sections 505(a) and 502(0(1) [21 U.S.C. [section][section] 355(a) and 352(0(1)] of the Act. Based on the information your firm submitted to FDA's Drug Registration and Listing System and the information collected during the inspection of your facility, you manufacture the following prescription drugs, including, but not limited to: * Ascor L 500, Ascorbic Acid Injection, USP, 500 mg/mL in 50 mL vial (McGuff Pharmaceuticals) * Ascorbic Acid Injection, USP, 500 mg/mL in a 50 mL vial ((b)(6)) * Ascor L NC, Ascorbic Acid Injection, USP, Non-Corn Source (500 mg/mL in 50 mL vial) (McGuff Pharmaceuticals) * Magnesium Chloride Injection, 200 mg/mL, in 50 mL Multi-Dose vial (McGuff Pharmaceuticals) * Magnesium Chloride Injection, 200 mg/mL, in 50 mL Multi-Dose vial ((b)(6)) * Vitamin B-Complex 100 Injection, 30 mL Multi-Dose vial (McGuff Pharmaceuticals) These products are drugs within the meaning of section 201(g) of the Act, [21 U.S.C. [section] 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases. Further, they are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. [section] 321(p)] because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act [21 U.S.C.[section][section] 331(d) and 355(a)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved for FDA under either section 505(b) or (j) of the Act [21 U.S.C. [section] 355(b) or (j)] is in effect for the drug. Based on our information, you do not have any FDA-approved applications on file for these drug products. The marketing of these products, or other applicable products, without an approved application constitutes a violation of these provisions of the Act.
The Vitamin C Foundation then retained FDA attorney Jonathan Emord and associates to evaluate the FDA action, and we have posted their analysis on our website.(22) Mr. Emord believes that the FDA is technically going "by the book" and there seems to be no current legal recourse. However, according to Mr. Emord, vitamin C is still readily available to cancer and other patients:
In sum, under the pharmacy compounding guidelines and laws, vitamin C for intravenous administration is still readily available to patients acting through compounding pharmacies, provided the patients obtain treatment through their physicians.
Mr. Emord's firm doubts that the FDA would be successful if it tried to stop compounding pharmacies from producing vitamin C for injections. From our understanding of the Emord analysis, we conclude that future action to make IV vitamin C more economically viable and generally available from commercial suppliers will reside in the political arena. We will assist health freedom groups working to expose the inane culprits in the FDA behind this action, those working to understand what new regulations the FDA is enforcing so that there can be the required public comment, and those working to enact new laws designed to make IV/C legal and allow the commercial manufacturing of vitamin C for injection to resume. If you feel the urge to help in the regard, we believe that the lack of reported adverse reactions for IV/C is a point that should be hammered on at every opportunity when you contact the FDA. Please monitor our website VitaminCFoundation.org for more information on these efforts and feel free to join our online forum.
Case Analysis: IV/C's Success Treating Mercury Poisoning Illustrates a Dramatic Difference Between Commercial and Cathcart-style Intravenous Ascorbate
Are all intravenous vitamin C infusions created equal and do they have equal effects, or are some demonstrably better than others?
The difference between the 2 different types of Intravenous Vitamin C is so dramatic to me that its obvious that Cathcart's formula is vastly superior. - Michael, the brother of mercury-poisoned woman
There are solid reasons to suspect that commercial vitamin C, now off the market, may have had only 50% of the vitamin C potency of the IV bags made from sodium ascorbate crystals such as those prepared in the Cathcart medical practice.(23) Physicians and IV/C users can no longer purchase the commercial solutions and are being forced to purchase small batches from a pharmacy or mix their own stock vitamin C (sodium ascorbate) solutions. The foundation would like to assure physicians that utilizing Cathcart's method is not only a good way, but almost certainly the best way to prepare vitamin C for infusions.
The authors also agree with Dr. Cathcart that the pH of the commercial solutions may be too low (acidic) and thus potentially harmful to veins during heavy use. Too low, Cathcart said, because of a "quirk" in the USP that requires the commercial stock solutions to start with ascorbic acid (not sodium ascorbate) and then buffer the solution with sodium carbonate. According to Levy, "The commercial IV/C bottles are buffered to end up from 5.5 to 7.0 in pH. When you mix up sodium ascorbate according to Cathcart's instruction, it reliably comes in at a pH of 7.0 to 7.4."(24)
Dr. Cathcart often made the statement that he experienced few problems with his IVs, despite the high number of infusions administered during his many years in practice. He was surprised by all the calls he received from other doctors who were experiencing problems with their IVs. While many of the problems were caused by the use of ascorbic acid intravenously (instead of sodium ascorbate), this error did not explain everything. The large number of queries from other doctors induced Cathcart to write a short paper titled "Preparation of Sodium Ascorbatefor IV and IM Use." We have updated and posted his document at the foundation website.(25) Additionally, the Vitamin C Foundation has posted a video recording of Dr. Cathcart's lecture on the preparation and use of intravenous vitamin C on youtube.com.(26) The salient points from these documents are that: (A) Cathcart's nurses produced their own IV stock solutions using sodium ascorbate, which they then refrigerated.(27) (B) The nurses did not mix vitamin C in the water right away. It was left at the bottom of the stock solution as a sludge and stored this way in the refrigerator. (C) The solutions are not mixed until just before they are added to the IVs. Made this way the solutions remained clear and did not turn yellow. (D) Cathcart added 1 gram of edetate disodium (EDTA) to the 500 cc stock solution. The EDTA acts as a preservative as recommended by author and biochemist Sherry Lewin, PhD.
(1.) For this reason, the late Dr.Robert F.Cathcart III said in his lecture on video that he did not even find it necessary to use a microbial filter when preparing his drips. His experience was with over 20,000 patients.
(2.) Knudtson ML, Wyse DG, Galbraith PD, et al. Chelation therapy for ischemic heart disease: a randomized controlled trial. JAMA. Jan 23/30, 2002;287(4):481-486.
(3.) The FDA has also banned commercial magnesium as an unapproved drug, which is also used in placebos.
(4.) Study of high dose intravenous (IV) ascorbic acid in measurable solid tumor disease [Web page]. Clinica|Trials.gov.http://clinicaltrials.gov/ct2/show/NCT 01125449?intr %22Ascorbic + Acid %22&rank=6.
(5.) Dr. Cathcart's instructions are available online at vitamincfoundation.org/civprep.pdf and on YouTube.
(6.) Although Dr. Klenner used the term ascorbic acid in his pioneering papers, Cathcart verified that Klenner was indeed buffering the acid and thus administering what was essentially sodium ascorbate.
(7.) The treatment of poliomyelitis and other virus diseases with vitamin C. J South Med Surg. July 1949. Subject of Klenner's talk to the AMA session of that year on polio.
(8.) Landwehr R. Flashback: the origin of the 42-year stonewall of vitamin C.J Orthomol Med. 1991;6(2):99-103. Available at:Http://kandylini.wordpress.com/2008/05/28/flashback-the-origin-of-the-42-year-stonewall-of-vitamin-c/
(9.) Levy TE. Curing the Incurable: Vitamin C, Infectious Diseases and Toxins.Livonbooks;2002.
(10.) US Food and Drug Administration. Warning letter to Proctor and Gamble [online document]. Oct. 29, 2009. Http://www.fda.gov/ICECI/EnforcementActions/ Warningletters/2009/ucm188361.htm.
(11.) US Food and Drug Administration. Warning letter to McGuff Pharmaceuticals Inc. Dec 28, 2010. Http://www. fda.gov/ICECI/EnforcementActions/WarningLetters/ucm238251.htm.
(12.) Zero deaths from vitamins, minerals, amino acids or herbs. See this issue, page 18.
(13.) For some idea of what these ailments are, one simply compares diseases common to humans, high-order primates, and guinea pigs with the rest of the animal kingdom, which can make their own vitamin C.
(14.) Living proof: vitamin C - miracle cure? [online video]. 3 News. http://www.3news.co.nz/Living-Proof/tabid/371/ articlelD/171328/Defaultaspx?ArticlelD - 171328.
(15.) We have found no record of consumer complaints. So we filed Freedom of Information Act request to find out more, but have been told it routinely takes several years to receive the FDA's answer to a FOIA request.
(16.) As Levy points out, now doctors are forced to order their vials from compounding pharmacists, which will make it much more expensive than if companies like McGuff could mass-produce thousands of vials.
(17.) Chen Q, Espey MG, Krishna MC, et al. Pharmacologic ascorbic acid concentrations selectively kill cancer cells: Action as a pro-drug to deliver hydrogen peroxide to tissues. PNAS. September 20, 2005;102(38):13604-13609. Available at:http://www.pnas.org/content/102/38/13604.full.
(18.) Moss R. The Cancer Industry: The Classic Expose on the Cancer Establishment. Equinox Press; 1996.
(19.) At that time, almost all the over-the-counter (OTC) medications had been removed from the market by the FDA for faulty manufacturing.
(20.) Anyone reading the FDA letter would assume that the panel was recently convened and the end result was the warning letter.
(21.) Starling S. Court finds combo drug ads not misleading [online article]. Nutralngredients-USA.com. http:// www.nutrai ngred ients-usa.com/Regulation/Court-finds-combo-drug-ads-not-misleading
(22.) Vitamin C Foundation. FDA position on intravenous vitamin c for limits access, but does not render vitamin C-IV unlawful [online press release]. http:// vitamincfoundation.orgjemordmemo.pdf
(23.) Levy highly recommends sodium ascorbate powder (private correspondence).
(24.) Private correspondence with Levy
(25.) Which we have updated and posted atvitamincfoundation.org/civprep.pdf.
(26.) Cathcart III RF. Cathcart's instructions on the preparation of vitamin C for I.V. use [online video]. YouTube. http:// www.youtube.com/watch?v=Zgi-7xPrCAg/Cathcart IVCprep lecture.
(27.) IV vitamin C should be sodium ascorbate (the pH of his preparations is generally higher than commercial)
(28.) Lewin S. Vitamin C: Its Molecular Biology and Medical Potential. Academic Press; 1976.
(29.) Due to the vein damage, they began using a PICC line, giving the Cathcart-style ascorbate through her arteries.
(30.) Success with vitamin C for mercury poisoning [online forum thread]. Vitamin C Foundation. http:// www.vitamincfoundation.org/forum/viewtopic.php?f=10&t=7563.
(31.) And yes, unfortunately, the report of $350,000 charged by the integrated doctor has been doubled checked and accurate
(32.) BarnettJ. It's OK to question AIDS [online video.] YouTube. http://www.youtube.com/user/resistanceisfruitful#p/u/0/mgRoR1-qw8Y
Owen Fonorow graduated from the United States Air Force Academy. He is retired from AT&T Bell Laboratories in Naperville, Illinois and now teaches college-level computer science. In 1996, shortly after Linus Pauling died, Owen co-founded of the Houston-based non-profit Vitamin C Foundation. The Foundation's mission is to fund vitamin C.
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|Author:||Fonorow, Owen R.|
|Date:||Jun 1, 2011|
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