From: CDER DRUG INFO
Sent: Friday, March 11, 2011 9:58 AM
To: Martha M Grout, MD, MD(H)!
Dear Martha M Grout,
Thank you for your e-mail expressing concerns about FDA's December 28, 2010 warning letter to an individual manufacturer (McGuff Pharmaceuticals Inc.) of intravenous (IV) vitamin C along with other prescription drugs.
Unlike oral vitamin C-which could be a dietary supplement- these particular IV solutions are, by law, unapproved drugs. Moreover, the manufacturers neglected to follow current good manufacturing practices, potentially exposing users to unnecessary risks.
Such risks have occurred before. In the E-Ferol tragedy of 1983, premature babies received E-Ferol, an intravenous form of vitamin E. E-Ferol was associated with adverse reactions in 100 premature infants, forty of whom died. It is highly likely that this tragedy would have been prevented if the product had been reviewed and approved by the FDA before its introduction to the market.
Since FDA announced its Unapproved Drugs Initiative in June 2006, marketers of unapproved drugs have been on notice that addressing risks from unapproved drugs is a high priority for FDA, and that the Agency plans to systematically and responsibly ensure that all products on the U.S. prescription drug market become compliant with current FDA approval requirements for safety and efficacy.
The mission of FDA's Center for Drug Evaluation and Research (CDER) is to ensure that safe and effective drugs are available to the American public. Drugs that have not been approved by FDA may not be safe and effective, may have been manufactured under sub-standard conditions, may contain too much or too little (if any) active ingredients, and may not have necessary labeling information and warnings.
FDA's drug approval process ensures that drugs are safe, effective, of a suitable quality and purity, and are properly labeled. The Agency remains committed to assisting all firms with meeting these standards.
Again, we thank you for your input and hope that we were able to address your concerns.
Division of Drug Information - HW
Center for Drug Evaluation and Research
Food and Drug Administration
Dr. Grout’s reply to FDA:
You addressed my concerns not even a little bit. Vitamin C in its intravenous form has been in common use for at least 40 years. The work of Linus Pauling still stands. A couple studies done at the Mayo clinic in Minnesota were disappointing as to vitamin C's efficacy until it was understood that Mayo had used high dose oral vitamin C. The delivery method is the key to its effectiveness.
The only adverse effect that I have ever seen has been hemolysis if it is given in large dose to patients with G6PD deficiency. For that reason, we test for G6PD deficiency before using this form of therapy. All of the companies from which I purchase the IV form of Vitamin C have it manufactured using the GMP standards.
Since June 2006, the FDA has begun to "systematically and responsibly ensure that all products on the U.S. prescription drug market become compliant with current FDA approval requirements for safety and efficacy." Explain then why you are ignoring so many problems. Crestor is so linked to rhabdomyolysis, Public Citizen calls it a Do Not Use and the FDA's David Graham named it one of the five most dangerous drugs before at a Congressional hearing. Yet it is still on the market. Soon after Bayer launched Yaz in 2006, 18-year-olds were coming down with blood clots, gall bladder disease, heart attacks and strokes. More than 50 reports of Yasmin or Yaz deaths were reported to the FDA between the first quarter of 2004 and the third quarter of 2008. Bayer was ordered to run correction ads but Yaz is still on the market. Researchers wrote in PloS One that Chantix is 18 times more likely to be linked to violence than other meds, yet it is on still the market. The last figures I saw about Chantix were 397 FDA cases of possible psychosis, 227 domestic reports of suicidal behaviors, and 28 recorded suicides, Some people use Chantix to stop smoking – works OK for some, but makes others aggressive and ugly. Chantix is optional, unlike a drug like penicillin for pneumonia. The diabetic drugs Avandia and Actos increase a woman’s chance of breaking a bone by 50 percent. If you’re over 65 years old, your chances jump to 70 percent (Morrow, R., Carney, G. et al. “Impact of rosiglitazone meta-analysis on use of glucose-lowering medications.” Open Medicine. 2010) The known deadly side effects of prescription drugs are the fourth leading cause of death in the industrialized world (JAMA, April 15, 1998).
No major toxicity has been discovered with Vitamin C in the past 40 years. Nor have you provided data as to the harm.
I cannot speak to the integrity of the manufacturing processes of any one company. Whether there was a problem with McGuff, I cannot say. But to issue a blanket edict against all manufacturing and therefore use of intravenous vitamin C makes clear that an agenda other than public safety is at work.
Vitamin C is not a drug. If a drug is, according to the Food, Drug, and Cosmetic Act, a substance other than food intended to affect the structure or function of the body, then vitamin C clearly is not a drug - be it administered orally or intravenously. You have failed to make that case that the IV form of delivery constitutes an unapproved drug. We are talking about a natural vitamin here, not a synthetic and patented drug developed and manufactured by the pharmaceutical industry. The use of intravenous vitamin C is good medicine with a long history of safety.
Please do not try allay my supposed fears by giving me information which is irrelevant to the issue at hand. The removal of the intravenous form of Vitamin C from the armamentarium of substances used in supraphysiologic doses to remedy significant nutrient deficiency is an act of foolishness, when examined even in the best of lights. You must reconsider an untenable position.