For the past 10 years, we at Drive to Cure Diabetes have raised $102,000 to support the work of Dr. Denise Faustman of Massachusetts General Hospital. We believed in her, her team, and the hope she gave us that one day, we'd be able to announce a "cure" for Type-1 Diabetes. Each year that passed we hoped that soon, our daughter and many thousands of other sons and daughters could start living without fear of highs and lows that invariably happen; that some day, they could sleep nights without fear.
It now seems the time has arrived!
We get monthly newsletters from MGH which often highlight Dr. Faustman's progress. The most recent one gave a cursury description of recent results that sounded promising. Since Kathi and I were heading to Boston to meet with Dr. Faustman to present her the check from our most recent golf outing event, I was particularly interested in discussing what she referred to as "expanded trials".When I first read about the "expanded trials" in an email from Faustman Lab, the email referred to a paper she published earlier. I attempted to read the paper, though much of it was too technical to understand completely. However, there were many tantalizing paragraphs that described a totally different result from what we were expecting.
We have mentioned here about the use of BCG to elevate the immune system to release a tumor necrosis factor that eliminates T-cells attacking the pancreas. This research was a totally different approach. The paper, which she published in "Nature" described an alternate pathway for the stability of A1C values in the initial phase 1 trial subjects over the past 5 years.
I was confused, so we asked her what was the real situation. She explained that the markers she expected to see in this initial group that would indicate production of insulin did not appear in quantities that would justify her results. That is, the pancreas was regenerating, at least for some time, but not to return the patient to a stabler A1C, and not like what she was seeing. So, she and her team looked a bit deeper, and this was the subject of the above mentioned paper.
It now appears that they have discovered a new pathway for BCG to lower blood sugars to near normal. The BCG seemed to modify an enzyme that induces absorption of blood sugar into cells, just as insulin does. What's more, this seems relatively stable, even when no more BCG is administered. Upon further examination, they noticed that the BCG acts upon the DNA to produce these lasting changes in enzymes, which were not present in the absence of BCG. It's like BCG modified the DNA, so that a previously dormant gene was now active.
Research indicated that, historically, the gene was active, but as we became more concerned for a sterile environment, the microbe in the body that would, on its own, produce BCG-like effects was now absent. As Dr. Faustman said, we no longer eat dirt with our foods. This microbe seems to be a very ancient one, existing as far back as traceable.
With this new knowledge, her team re-examined her earlier results with mice and noted that they, too, had the genes expressed. So, current hypothesis is that this is a long term, and quite natural solution to type 1 diabetes, and also explains why it appears to work on patients of any age and who have had the disease for many years. It was always inside of you, just waiting for the right key.
Go to the paper linked above, and scroll down to the "Results" section. There you will find the following:
"BCG treatment subjects with the improved and tight blood sugar control demonstrated blood sugar stability and lowered blood sugar persistently for 5 continuous years after the initial drop in values. Semi-annual surveys confirmed that during year 03 to year 08 after BCG vaccinations there were no reports of severe hypoglycemia by any patient, even with lowered HbA1Cs near the normal range, and no change in their care as it related to new insulin pumps or continuous glucose monitoring devices."
In layman's terms, no need for insulin for five years!
As for the new "trials", these would not be like a real trial, i.e., use placebos in some patients, while others get the good stuff. Back in the 70's, when AIDS was killing thousands, testing was done on drugs to extend lives and to put the disease into a more dormant state. But it was unbearable to know that lives could be extended rather than lost, if only the program could be shifted into another phase, opening the good stuff to all who wanted it, since it seemed to be very effective.
The FDA started such a program, where the only requirement would be that the new recipients would have to have blood checked occasionally, and the patients would be responsible for any costs incurred, like nurses to take blood and do the actual analysis. Just to keep the records. She has gotten permission to use the same style program, where one would need to get to Massachusetts General Hospital, three times a year, at one's convenience. The Lab might ask that the participant do some routine blood testing, but nothing like a diabetic does now: perhaps every few days or so. This will begin next year after the lab raises start-up funds. It would start showing results within approximately 3 years and the effect can last for over 8 years of the start of the BCG without the need for re-vaccination.
"Drive to Cure Diabetes", our 501(c)3 is our attempt to help raise this money.
Even if you don't play golf, you can contribute to our organization by clicking on the "Make a Donation" page.