Newsletter # 6 WAITING FOR FDA APPROVAL
Much has happened since the last newsletter. Dr. Faustman has had positive results in Phase 1 of her BCG studies, and with as little as 2 injections, has increased C-Peptide production in 2 test subjects. Results were published in about 20 sources at last count.
Money is now being collected for Phase 2, which gives greater doses of BCG to a greater number of test subjects. However there is one more thing before Phase 2 can proceed: the FDA (Food and Drug Administration in the US) must approve the study’s parameters. That is, how many test subjects, the amount and frequency of dosages, and for how long.
In Phase 1, the FDA did not allow Dr. Faustman either the number of subjects, nor the frequency of dosages she requested. She originally requested 12 subjects be given dosages 3 times a week. Instead she was allowed only one much smaller dose per subject at 4 weeks apart, and only 3 subjects. For a drug with a long-term proven safety record, it makes one wonder why the unnecessary restrictions? But even though there may have been so little to go on, there were obvious, measurable, positive results. Enough to merit another study of more intense therapy.
THE EXTREMELY CAUTIOUS FDA
Now we do the Big Wait, to see what the FDA will say. And the question still looms large: Why wouldn’t Dr. Faustman, a responsible and caring doctor, be allowed anything and everything she needs to safely conduct a study?
One possible reason could be the health risks of administering BCG to patients. Well, maybe. But at one time, in our not too distant past, BCG cured our world of Tuberculosis, and has already been proven SAFE. Because of this safety record, you’d think in Phase 1, that BCG could have been administered more often than twice, 4 weeks apart, and with a higher dosage than 0.1 ml of 1.6-3.2 x 106 colony forming units.
Another reason could be that the FDA is concerned with health risks down the road. Long term health risks may not show up for decades or more. That’s true, but besides its already proven long term safety record (ninety, 90) years, how would anyone know unless someone tries it?
I’m not sure how the matter of test subjects is handled, but I would imagine these people would be well aware of possible health problems to any new medication or procedure. I’m sure they’d be willing to assume these risks in order to pave the way to a possible cure.
Imagine when insulin was first isolated and administered. They didn’t know the dosages at first, or that exercise/stress/etc., etc. affected blood sugars. But they went ahead anyway. We have those brave first patients to thank for how we know insulin works today. I’m sure these people testing BCG understand any risks, and will take them in order to benefit all humanity.
Is there any other reason why the FDA shouldn’t allow Faustman anything and everything she needs in these trials? Is there any actual, scientific, logical, factual or otherwise really apparent reason the FDA should restrict Phase 2, either in the number of test subjects, or the required dosages? I challenge any doctor to tell me in layman’s language.
Is it possible that Big Pharma has a stranglehold on research? And that profit is more important than finding cures? How many research projects can you find that aren’t funded by pharmaceuticals? Does anyone else besides us see a conflict of interest here?
I know a lot of people are happy with the way things are. They’re happy not rocking the boat. They’re happy to sit on the sidelines and throw up their hands in passivity. Why not? It’s worked before: Just look what it’s gotten us?
But if you’re willing to lend your voice to an injustice, there are ways and procedures, now with the internet and social media, to communicate this to the higher ups. The Arab Spring and Quebec student protests stood up for a heirarchy run by greed, and they won!
I challenge you to talk about what can be done, with other diabetics, with friends or family, your diabetic clinic, and even your family doctor. But I would warn you that talking to your doctor would have a reaction ranging from mild “pooh, pooh” to outright hostility, as was the case with 2 doctors I mentioned this to. (More on the confusion of doctors in another newsletter).
Another thing you could do is copy Dr. Faustman’s webpage including references to the research papers (www.faustmanlab.org), asking your doctor to look at it later.
I challenge especially women. I’ve noticed many women in our society are passive, not taking a stand on anything. But to these women I would say: Ma’am, you don’t know how powerful you are! For its only when women lend their voices to a cause that things really change. Why? Because a woman is the communication centre of a family. When a woman talks about something, everyone in the family, whether they agree or not, knows something’s up.
To be aware of other things that can be done, I direct you to check out organizations such as Avaaz, who have done amazing work. You could also write to your MP, or if the decision of the FDA is less than satisfactory, to email them when the time comes. You could also mail this article to anyone you think might be interested.
In closing, I would say that we can make our wishes about ineffectual and unnecessary restrictions to Dr. Faustman’s Phase 2 trials, known to the FDA. We can do it if we are watchful about what is happening, and if necessary, are united in one voice. Our cause is the right cause.
In the next newsletter, we explore why your doctor hasn't heard of Faustman's studies.