The famous and controversial diabetes cure researcher Dr. Denise Faustman has just published exciting new research results showing evidence that “insulin production may persist for decades after the onset of type 1 diabetes” and “beta cell functioning also appears to be preserved in some patients years after apparent loss of pancreatic function.” Her study results appears in the March issue of the journal Diabetes Care.
“The traditional concept is that in type 1 diabetes, the pancreas is dead within two years. What this data now 
shows is that it’s not an acute disease where the pancreas dies in that short interval. Rather, in the majority of people, it’s a gradual, slow decline,” explained Dr. Faustman, when I spoke to her on the phone last week.
“This opens the question of what is the window for people with long-stage diabetes to still have a chance of being rescued. The time course of the disease is altered by this data!”
Dr. Faustman is nothing if not enthusiastic. One could even describe her as bubbly — which may account in part for the passionate following she’s amassed for her controversial approach to cure research, using a substance called BCG vaccine to kill off the cells that attack the insulin-producing cells in type 1 diabetics.
This latest data was almost a byproduct of that work, she explains. Traditional “intervention” research focuses on patients newly diagnosed with diabetes, usually within one year. But Faustman’s group could not afford the millions of dollars that big Pharma invests in locating and recruiting new onsets.
“Everybody’s jockeying to try to get these kids, but we can’t compete at that level for a cheap generic drug (BCG), and also, we already had mouse data showing that BCG actually worked long-term,” she says.
So her group recruited adult patients with long-term type 1 diabetes even though they believed they were dealing with dead pancreases, she explains. When samples from these patients were sent off to Sweden for an ultra-sensitive C-peptide test, one surprising result that came back was pancreas activity. “The average in our group was 15 years out from diagnosis, and they all had some residual pancreas function. Actually, it’s functioning at low activity but it’s alive!” Faustman giggles.
What this means practically is that going forward, more PWDs should be qualifying for clinical trials — as even us long-timers are now candidates for beta cell regeneration studies.
Figure from Faustman's latest paper
“It’s kinda like renewed hope for patients. They’re saying, ‘you mean my pancreas isn’t dead?’ It’s a new concept for people with type 1 diabetes that their pancreas lives on for a long time. This gives us a bigger window of treatment than we had thought we had for a long time,” Faustman says.
Giving Credit, Finding Corroboration
Faustman is quick to point out that she’s following in the footsteps of a certain Dr. Alan Foulis, a pathologist in the UK who for many years kept reporting that he saw islet cells in the cadavers of patients with type 1 diabetes. In the research world, “everybody poo-pooed it, because they…did the standard C-peptide test on living patients and didn’t see any function.” Faustman says her new data is “the first functional data showing that the pancreas is working for a long, long time making insulin.”
A certain Dr. Bart Roep based in Leiden, Netherlands, might disagree there. He appears to have just published a study that discovers exactly the same thing. “His discovery negates earlier research which concluded that (insulin-producing) cells are completely absent in type 1 diabetes patients,” according to an Expatica.com article with the unfortunate headline “Dutch Professor: Type 1 Diabetes Can Be Cured.” That sensational headline has the ill effect of making Dr. Reop sound like an unrealistic idealist, instead of a serious researcher whose findings indicate, in his own words, that “if these cells can be reactivated the patient could be cured, even as long as 10 years after the original diagnosis was made.”
The work of Drs. Foulis and Roep is good news for Dr. Faustman, in the sense that her findings are supported by the work of other researchers. The way I understand it, a lack of corroboration by her research peers is what makes Dr. Faustman’s BCG work so controversial, and is also the reason she hasn’t received funding from established sources, like the JDRF.
Endless Honeymoon?
Naturally, I asked Dr. Faustman what this all meant for the theory of the “honeymoon phase” in type 1 diabetes. She says that previous thinking about the honeymoon lasting just 6 months or a year and then ending abruptly is probably false.
“The pancreas activity is gradually getting lower and lower — it’s not a 6 months’ decline, but at 10 or 20 years, the A1C’s are getting worse. Everybody blames the patient, but it gets harder and harder to manage,” she says. Amen to that.
Faustman’s BCG Trials Update
So what’s happening with Dr. Faustman’s BCG vaccine trials? They hope to re-start Phase 2 pilot studies within the year, she says. Of their $25 million goal, her group has raised $10 million in philanthropic donations thus far, “so we have a ways to go – although this is cheap compared to other trials conducted by big Pharma,” she says.
“We’re now trying to sustain the vaccine in patients – to get rid of the ‘bad T-cells’ so the pancreas has a higher and higher chance of recovery.”
They’re working with the FDA on guidelines for the study, which Faustman says is a new concept for the FDA, because the agency’s current guidelines focus on trials working to change the rate of decay of the pancreas. “Ours is the first data they’ve seen where the pancreas could be turned back on, so the guidelines don’t quite fit. What should the end points be? To what level do we have to turn the pancreas back on (to be considered successful)? And for how long?”
They’re also working on the Phase 2 trial design: pre-screening patients and defining the population of subjects who should be included. “We’ve got people booked out for four years from all over world who want to get pre-screened,” she says. “Some just want their name on the list, some want to send us their clinical info, and some want to come visit and give us blood samples.”
Despite the onslaught, Faustman’s still encouraging new patients to get in touch with her Boston-based lab. If you’re interested, visit www.faustmanlab.org. No matter how long you’ve had type 1 diabetes, you’ll be happy to know you no longer fall in the “DEAD PANCREAS” file.
I never believed the pancreases were dead in long standing type 1 diabetes! The fact that some have an easier time than others to control the disease may lend additional credence to this topic. That said, the JDRF is no longer run by parents of type 1 diabetics but individuals with their own agendas (Brewer & his AP) and financial relationships with academia and big pharma. Look at the JDRF donor lists on their website! All that would end with a cheap solution (BCG) and negate them their $$$$$ windfall from the AP and stem cell research that has basically no clinical trials for T1 taking place.
I hope Dr. Faustman can change the paradigm for how research is working towards a cure for a disease that has impacted 2 generations in my family; over >100 years combined of living with T1.
it’s funny how exciting research has become now that I have a little one with diabetes! Hats off to her, her research and her enthusiasm. The world is lucky to have these motivated scientists. They give us a lot of hope.
Will those of us with LADA be able to participate? Will the vaccine work for us, as well?
interesting research. thanks for the updates. hope it works!!!
The Joslin 50 yr study has shown the same thing. I.E. over half the participants (all have had diabetes type 1 for at least 50 yrs.) still produce small amounts of C-peptide when they used a sensitive C-peptide test.
I have also wondered if the auto-immunity ways over time. As far as I know I do not produce measurable C-peptide and have insulin auto-antibodies only. Perhaps if the insulin antibodies could be stopped the beta cells could be waked up without producing the Islet cell antibodies.
Amy: You should contact Dr. Hillary Keenan at Joslin Diabetes Center. Hillary is doing the research on the 50-Year Medalist Study, and has found results in most of the medalists that are similar to Dr. Faustman’s findings. Autopsies of pancreases donated by 50-year medalists have shown that there are some working islet cells in those pancreases.
Tom Beatson
T1 for 69 years
The people who achieved the 50 year Joslin medals had functioning beta cells and insulin levels that were not zero. Is there something that can be done to slow down this decline. some people believe very low glycemic index diets and alkaline diets will help the beta cells last longer. Do you think these types of diets may help to slow beta cell destruction?
There are several cases known where people with Type 1 had a bone marrow transplant, which acted as a reset of their immune system. They would all regain their beta cells and became insulin independent until their “new” immune system started destroying beta cells again.
We also all know that we don’t loose our beta cells at a similar rate. We currently call the fast end of the spectrum “classic” type 1 and the slower end LADA. I don’t want to enter the debate on whether they are seperate conditions, but we all know that the process of beta cell destruction doesn’t have a set timetable.
Taking above into account, I do agree that faustmans idea of stopping the process of destruction by changing the responsible T-cells has merit.
While I don’t wanna gun down islet/beta cell transplants, the problem from the bone marrow transplant cases seems to indicate that recovery of beta cell function is capable without transplant. If we are able to stop the destruction, current data suggest we would eventually recover beta cell function on our own.
Now again, I do not know whether there is just 1 type 1 of diabetes. But there is alot of variety among type 1′s. Much as I lament it when a newspaper headlines “Cure for Diabetes closer!” and never once during the article mentions the type 1 or 2 difference, I am also sometimes worried that a “type 1″ cure may not work for everyone currently classified as “type 1″ and that indeed how long the body has undergone the process of beta cell destruction may be relevant to its ability to regain beta cell function.
As for the dutch doctor (I am Dutch), his research is hyped alot in local media as well. And he does portray an optimistic picture, but what he presents is not out of bounds. His idea is actually similar to those of Faustman, like dr Faustman he seeks to change the T cell behaviour.
The difference between Roep and Faustman is however in how they seek to bring this change about, partially because they don’t seem to agree entirely in why the T cells behave the way they do.
Roep slightly varies also by posing that hard working beta cells secrete a substance that makes them attract more immune system activity. The theory has merit and he has some actual data to back it up, but it is far from proven.
Roep and his research are sponsored by the Dutch Diabetes Foundation by the way and he is a professor in which I can only translate as diabetology at a well-respected university.
I have some reservations about his optimistic press to the media (last time wasn’t the first), but his research is sound.
Thanks for this, Amy. Very exciting news indeed.
Well I am getting close to four decades with diabetes and hoping I have a chance at recovery before this disease takes me down. I found the latest article published a few weeks back about the Stem Cell Educator treatment using Cordblood very promising. They apparently got some really impressive results in slowing down the immune attack and allowing most of the patients to reduce their daily insulin up to around 35%. There were also no safety issues were reported. If I can’t get recovery of my own cells I will look towards what Viacyte is doing. I think something like that would be my best shot.
Conventional medicine suggests that certain types of soft tissue damage [spinal cord, kidneys, islet cells] are essentially irreversible. It always stuck me as more likely that there is always some regenerative capacity for all types of human tissue. It comes down to a question of kinetics; i.e. is the mechanism that is causing the damage so aggressive that it overwhelms the slower regenerative capacity of the cells. In this case, the result would be a continuing loss of function over time and the anecdotal belief that no repair is actually occurring. However, what happens if the mechanism of damage can be slowed to a standstill or the kinetics of regenaration can be accelerated such that a net positive rebuild of cellular activity can occur instead of continuing decay? This seems like the holy grail to be searched for in the field of regenerative medicine.
This research looks very interesting, but since there are no collaborators outside the Boston area, she is missing out on as good number of volunteers. I would be more than happy to be a part of this research, but I live in the Memphis area. JDRF needs to get it together and sponsor such research. You never know what will work until you have tried everything.
I view the research as a scam and a vehicle to keep the money and employment for Fastman flowing.
She talks about big pharma attracting all the new onsets and her being stuck with established diabetics because of money. She did not return my email when I volunteered my daughter who was newly diagnosed.
We know BCG is safe. I will get on a plane with her and fly to a 3rd world country and start curing kids. (All at my expense) Probably not that comfortable for her outside of Boston though.
[...] Diabetes Mine By AmyT on February 27, 2012 [...]
My son was recently diagnosed this year, when I started reading about Dr. Faustman’s research it gave me hope (even though a nurse on his diabetes team who has type 1 hadn’t heard of this Dr. and warned me not to trust to much into it). Although, she even said she believes there will be a cure in his lifetime. He’s 4 1/2 …..
You really think “Big Pharma” will let a cure for diabetes get to market? I have been watching this circus for 35 years…….and “researchers” lol such as Faustman forget it, they use this pseudo research to promote themselves – and it works, look at all the $$ pouring in!
For more info on her successful phase 1 human clinical trials, check out my diabetes video blog at: http://www.youtube.com/watch?v=YUIAPB7pMX4&sns=em
Big Pharma…you’ve got it!
But Denise is a seperate entity.
Her goal is the actual cure, NOT money.
It’s never been, “the money” for her.
One of the root problems is that it is: REALLY BIG MONEY, I pray for her.
My Idea #diabetes & #faustmann … Still not convinced its a permanent cure (or a cure that will work for everyone) . But, BCG could be used in cycles to deplete insulin autoreactive T cells before an islet transplant which might make islet cell transplants more successful since it would help stop the destruction of the new islets even with immunosuppressants.
….Interview with Dr. Faustman July 2012, the circus has a new clown…
http://cureresearch4type1diabetes.blogspot.com.au/search/label/Faustman
Why can’t this trial be done in a country where there is not that much red tape.millions of dollars are needed just to do the paper work! We need a cure and we need it now!
Dear Alexis, Thank you for your recent qsuteion on our Bel Marra Health blog. The study relates to high fat meals such as fast food. A small amount of cream in your coffee should be fine. As for Bailey’s, the study did not look at alcohol so we are not sure if there is an effect when mixed with caffeine. Thank you one again and have a great day
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