Vitamin Product Banned After Snatching Man from Death
Reprinted from http://www.medfoxpub.com/
Doctors were ready to pull the plug. Allan Smith, a New Zealand dairy farmer who had been diagnosed with swine flu, had been in a coma for nearly nine weeks. While there was nothing more traditional medicine could do for the man, Smith’s family insisted that he be administered high doses of vitamin C as a sodium ascorbic IV.
After a battle that lasted several weeks, the hospital’s medical staff finally agreed to administer the treatment every six hours. Smith made rapid improvements almost immediately, and he has since recovered fully.
Featured in New Zealand’s 60 Minutes television program, “Living Proof!,” Smith’s story has been called one of the most remarkable turnarounds in New Zealand medical history. Now, the FDA is putting the future of the treatment that saved Smith’s life in jeopardy.
According to the FDA, McGuff Pharmaceuticals, Smith’s supplier of intravenous vitamin C and the world’s largest manufacturer of the solution, is violating regulations by marketing their treatment without applying for new drug status. In a letter sent to McGuff on December 10, 2010, the FDA told the manufacturer to “discontinue manufacturing and distributing all of your unapproved drugs at all facilities immediately.”
The FDA says that products like sodium ascorbic and vitamin B complex injections do not qualify as grandfathered drugs or drugs marketed prior to 1938. If they do not undergo the cost-prohibitive new drug approval process, they cannot be sold.
Defenders of McGuff Pharmaceuticals and injectable vitamin C say that forcing vitamin C to go through the drug approval process is just as ridiculous as making saline or dextrose go through the same drug approval process. According to Owen Fonorow of the Vitamin C Foundation, not only is vitamin C one of the most studied molecules in the history of science, but it’s also demonstrably safer than these other “safe” treatments.
While McGuff Pharmaceuticals remains in full compliance with the FDA, the company is working to get the treatment back on the market. The Vitamin C Foundation has also set up a page for concerned parties to contact the FDA in support of intravenous vitamin C.
December 8, 2011 @ 12:29 pm Julia Schopick
Patrick: Thanks so much for this posting. I have shared it on my Facebook Wall.
I find it very upsetting when the FDA demands that treatments that are obviously safe, and have been helping people for many years, go through costly clinical trials.
This is ridiculous – for many reasons. One is that, if this, and other treatments that have stood the test of time, were to go through clinical trials, their cost(s) would skyrocket.
Actually, there are many instances of low-cost, effective drugs that are made by compounding pharmacies and that are, hence, affordable for patients. The trouble often starts when a pharmaceutical company gets FDA approval for the drug and sells it at a huge markup.
One recent example is the case with KV Pharmaceutical Company. They took a drug, called 17-P, which had been used for years by high-risk women to prevent premature births that cause severe defects and even death. Once KV had a monopoly to sell 17P, it renamed it Makena, and raised the price per dose more than 100-fold, making it unaffordable to many women.
There are other cases like this one. One of the drugs I write about in my book, “HONEST MEDICINE,” is Low Dose Naltrexone (LDN), used off-label for 25 years by many doctors for autoimmune diseases, such as MS, Lupus, Rheumatoid arthritis, Crohn’s disease, etc. LDN costs $40 a month (maximum) through compounding pharmacies. (Naltrexone was approved in the mid-1980s by the FDA for another purpose—drug and alcohol addiction—at TEN TIMES THE DOSE that doctors are now using it off-label for autoimmune diseases.)
I understand that Dr. Bernard Bihari, the physician who championed LDN’s off-label use for autoimmune diseases, was in conversation years ago with a drug company to put it through trials for this “new” use. But the pharmaceutical company in question told him that—if they paid the freight to put LDN through clinical trials—they would have to charge patients (and insurance companies) a huge amount of money. He refused. He simply couldn’t condone patients (and insurance companies) having to pay exorbitant amounts of money for a drug they could get so cheaply through compounding pharmacies. So, LDN is still produced by compounding pharmacies; patients still pay $40 or less per month for it. LDN has a HUGE patient following, but because it doesn’t have FDA approval for use for autoimmune diseases, many doctors still refuse to prescribe it for their patients—despite the fact that it helps so many people.
In years past, the FDA has kept many dangerous drugs from harming patients. Unfortunately, they haven’t been doing their job very well in recent years, with several dangerous (even lethal) drugs being put on the market on their watch. Just as bad is when they keep extremely safe treatments from helping patients the way they are doing in this case.
McGuff is a leader among compounding pharmacies. I am so sorry this is happening to them.
Again, thanks for this important posting.