My husband has Type 1 Diabetes, and we pay $400 out of pocket every month just for his insulin! I often hear sad stories of diabetics who have lost their limbs or gone blind. I also hear about young kids being diagnosed with the disease, and it makes me sick to my stomach.
But, what if my husband, along with the other 1 million type 1 diabetics in the US could get a simple and inexpensive injection to jump start their pancreas?
Dr. Denise L. Faustman, Director of the Immunobiology LaboratoryÂ ofÂ MassachusettsÂ General Hospital (MGH), has been independently investigating using an 80 year oldÂ TuberculosisÂ vaccination, orÂ BCG, known formally as bacillus Calmette-Guerin,Â to reverse type 1 diabetes.
At first this sounded too good to be true and I hesitated because this potential cure would mean my husband would have to get vaccinations. If you read other articles I’ve written about the dangers of vaccination and the nasty ingredients they are made with, you may understand my hesitation.
So, I decided toÂ write to Faustman to ask her about this. I asked if there was a way she could recreate the vaccine to only use the ingredients necessary for the cure. She responded,
Â Remarkably this is such an old vaccine, not much is added, unlike new vaccines. Â The other ingredients are sodium glutamate, magnesium sulphate, dipotassium phosphate, L-asparagine, ferric citrate, glycerol, citric acid, and water.Â This is basically salts with a little sugar, so no worries â no mercury, adjuvants, etc. Â The additives look like what is on the side of an energy drink.
Right then I became more interested in the whole idea!
Faustman has come a long way and has more than 20 years of research on autoimmunity and type 1 diabetes under her belt. She is very confident and enthusiastic that this generic drug just may be a type 1 diabetic cure!
When Faustman started at MGH in 1985, she was focused onÂ transplants. She learned from the work of a pioneer in the field, Dr Paul Lacey of Washington University in St Louis. She was determined to make transplants work. She wanted to find a way to stop the cells of the pancreas from being attacked byÂ autoimmune T cells so transplants could work.
But, surprisingly she discovered, this was more than a decade ago, that the pancreas of the mice injected with BCG started making insulin on their own!
It was then that she figured out the BCG actually helped stimulate the production of tumor necrosis factor (TNF), which killed the bad T cells that were attacking the pancreas. So by raising the levels of TNF using the vaccine, she was able to cure type 1 diabetes in mice.
A greatÂ articleÂ by the Huffington Post on the topic explains,
Â With the autoimmune T cells out of the picture, islet cells (of the pancreas) regenerated and began producing healthy amounts of insulin.Â By 2006, other scientists – including some who had attacked Faustman’s claims of regeneration – had replicated key findings of her mouse studies, laying the foundation for the clinical trial.
Faustman’s studies have raised someÂ controversyÂ in the research world because her findings go against the mainstream belief that when you have type 1 diabetes your pancreas is dead. But, she proved that this is not the case, as did other scientists who have replicated her results.
Today, Fuastman’s studies are unique because she focuses on diabetics who’ve had the disease for an average of 15 years, rather than past studies that focused on prevention or diabetics who had just been diagnosed.
So far in phase I, she has found that her theory works as well for people as it does for mice. In her latest newsletter from Fuastman Labs, she summarizes her phase I findings,
In the study, we saw that BCGÂ treatment could eliminate theÂ disease-causing T cells (the onesÂ that attack and kill the insulin secreting cells of the pancreas).Â We also saw early signs that theÂ pancreas was starting to produceÂ insulin againâat least brieflyâafter years of dormancy in thoseÂ who received treatment.Â Together, these data show theÂ potential of BCG treatment or aÂ similar therapy to turn the pancreasÂ âback onâ, even in people whoÂ have had type 1 diabetes for moreÂ than a decade.
Thankfully, Faustman was able to raise funding from individuals and foundations for phase I.Â An article by Bloomberg quotes FaustmanÂ explainingÂ that she tried to get funding from every major drugmaker, but they all told her there wasn’t enough money to be made in a cure that used a generic and inexpensive vaccine.
I personally questioned Faustman in an e-mail about this. I said, “I would love to know your take on pharmaceuticalÂ companies. People in the natural health/alternative health world believe that Big Pharma and the FDA, healthcare industry, etc, are all on one big team to keep people sick… In other words, why would they want a cure for Diabetes when it makes them so much money?”
“This is the reality of every company. Â They have to make money â they are in the business of making money, which means chronic treatments are lucrative markets, ie diabetes, hypertension, high cholesterol. Â You can make a car to last 20 years but you make more money if you make cars that last 5 years, therefore car makers make cars that are not built to last. Â Just like dishwashers, computers, etc. If a new drug costs over $1bn to get approval, and that drug takes away the market, they cannot recoup their expenses. Â It is that simple. Â Pharma is not bad, they just do not have a model to move cures forward. That is why this program is totally supported by philanthropy. Â People and true non-profits want cures.”
The model for drug development is broken â a topic that is too big for me to tackle but if you can prove in this one case that a cheap generic cures, it will help to increase awareness of the value of public interest and support for the biggest impact.
One person whoÂ trulyÂ believes in Faustman’s research is Lee A Iacocca, former CEO of Chrysler Corp and founder of the Iacocca Family Foundation. A year after Iacocca lost his wife to type 1 diabetes in 1983, he foundedÂ The Iacocca Family FoundationÂ in memory of her. That year, he also wrote his autobiography, Iacocca, selling 7 million copies. It was then that he became a true celebrity.
Today, Lee and his daughters, Kathryn and Lia, continue to live out their foundationâs mission toÂ fund research that will one day lead to a cure. So far, he has given more than $17 million to Faustman’s research efforts and continues to support her work. The total need for Phase II of her research is $25.2 million.
This may seem like a lot, but it’s actually quite cheap considering most other new drug research costs billions.Â When I asked Faustman about the cost of funding she said,
We are cheap on this drug â since we are generic, but still, the process is expensive and highly regulated. Â We should be about 1/4 the cost of a new drug.
Currently, phase II is underway with only $11.7 million left to raise. This will be a much larger trial. Faustman tells us some of the key steps involved in Phase II of her research, including
Working on trialÂ design, submitting regulatoryÂ documents to the FDA, setting upÂ a data safety monitoring board,Â determining the criteria forÂ patient selection, further refiningÂ the methods for monitoring drugÂ efficacy, andÂ identifying whichÂ outcome measures will be usedÂ to determine whether the trialÂ is a success.
As for what she hopes to accomplish, she says,
The Phase II trial will look at what dose and schedule we need to use to make BCG a functional andÂ sustained type 1 diabetes therapy. In Phase II, we will try to sustain the favorable T cell and pancreasÂ responses in people withÂ long termÂ diabetes that we observed transiently with limited dosing in ourÂ Phase I trial. Trial design and endpoints will be determined with the FDA and MGH clinical trial team.
My husband could stop taking shots for everything he eats, he wouldn’t have to worry about the destruction that low blood sugar or high blood sugar has on his body. He won’t have to fear having his limbs amputated or going blind. Maybe his life expectancy would increase. Maybe insurance companies would finally allow him to get life insurance? Maybe he could even give blood?
Let’s just hope and pray that Phase II brings positive results. And that Big Pharma and the FDA don’t put theÂ ca-boshÂ on bringing BGC to market because curing a million diabetics would result in a loss for them.
Support Faustman Lab
There are many ways you can help support Faustman’s research.
DonateÂ to Faustman Lab.
Host a special event orÂ fundraiser.
Sign up to get updates about Faustman’s research.
Spread the word by downloading and printing Faustman’sÂ fundraising brochure.
Read Faustman’s journal articles and abstractsÂ here.
Also watch thisÂ Video: New Hope Against Diabetes posted August 9th 2012