Benfotiamine - The Fat Soluble Form of Vitamin B1
2/19/2003

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Something Has to Give - Update
    The current president of the American Association for the Advancement of Science, Floyd Bloom, M. D., says, "The US healthcare system is 'in imminent danger of collapse' and needs a radical overhaul. The neuroscientist-physician used his conference address to highlight the healthcare 'crisis' now facing the country that spends more on medicine than any other nation on Earth." 
US healthcare in 'danger of collapse'  - BBC

FDA Approvals and Tuesday's Benfotiamine
    As an example of the pharmaceutical challenges in the United States, consider the following three articles about the "new" pharmaceutical discovery "benfotiamine", a fat-soluble form of vitamin B1.

 Thiamine Derivative May Halt Diabetic Complications - Google , and,
Synthetic vitamin could help diabetes-related eye disease, study shows - Nando Times
Backpain drug 'may aid diabetics'
  - BBC

"When 20 rats that had suffered diabetes for nine months were given benfotiamine, diabetic retinopathy was averted", Brownlee adds. "'Not a single rat developed the retinopathy, which is a condition that occurs in many diabetics when high blood sugar damages the retina of the eye, leading to visual problems and often blindness.'

"While several pharmaceutical companies are working on releasing drugs that will halt one of the pathways, 'this is one compound that prevents all three of the pathways,' Brownlee says.

"There is every reason to think benfotiamine will work equally well in humans, he notes, since the mechanism in humans is the same as that of rats.

"Brownlee plans to study the effect of this compound in surrogate human cells.

"Those with diabetes should not run out to buy thiamine-rich foods or vitamins, he stresses. "Thiamine doesn't do the same thing" as benfotiamine, and the derivative is not sold in North America, he says.

"However, there is good news, Brownlee adds. A small company in Germany called WorWag Pharma has been producing and selling benfotiamine for some time, to treat various neuropathies. Therefore, the medication is already used in humans and is deemed safe, he notes.

"However, 'the question, when looking at a particular agent, always is: What else does it do? We need to know what it [benfotiamine] does over time' and ascertain that it doesn't cause damage in other areas of the body, he says.

"'This is an important first step,' Hellman says, but 'there is so much more we need to know about this substance. I would strongly recommend that people not try to procure it' before more extensive tests have been done to ensure it isn't harmful."

Benfotiamine has been prescribed in Germany for ten years
    Benfotiamine has been approved for human use in Germany for ten years, with no harmful side effects, but we're going to start all over again, with animal studies. Then we're going to run double-blind Phase I, Phase II, Phase III, and Phase IV tests on humans. There are several pharmaceutical companies working on their own less-effective drugs. Ten years and a billion dollars from now, if anyone wants to take on the other pharmaceutical companies that are working on inferior products, we might get permission to use this fat-soluble form of vitamin B1 in the U. S. Dr. Brownlee mentions that benfotiamine should be a low-cost drug, since it's an analog of vitamin B1. But if it costs nearly a billion dollars to get FDA approval for a drug, I'm wondering if "cheap" and "FDA-approved" aren't mutually exclusive terms.
Available from Bulgaria
    That may be why Dr. Brownlee has mentioned WorWag Pharma (in Bulgaria). However, if I'm correctly interpreting WorWag's price list, benfotiamine ("Benfogamma")  isn't exactly cheap there, either. I suspect the "Public Pharmacy" prices my be given in "Levs", and that 2.22 Levs = $1 U. S. If so, that means that each pill would cost about $2.60.if you bought 50 of them, or $2.40 each in lots of 100, not including shipping costs. (These prices are valid from Monday onward. You wonder they were before the articles appeared on Monday.)
    Oh, well. If you're in danger of diabetic retinopathy, it's undoubtedly worth it. And it's a vitamin. And as long as we can go overseas and buy it, we have a way out. It would be good if it had FDA approval... if it didn't take so long and cost so much... assuming that anyone would spend that much for that long, in order to bring it to market.
    I wonder if Vitamin B1 ever got FDA approval? I wonder if anyone would invest in getting FDA approval for it today? How certain are we that Vitamin B is pharmacologically safe? And what about vitamins A and D?