JDRF and ADA’s Wary Response to Dr. Denise Faustman’s Findings

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Today JDRF and the American Diabetes Association released a joint statement on the findings of Dr. Denise Faustman’s recently published study:

On June 25, Dr. Denise Faustman presented data at the ADA’s 78th Scientific Sessions, and the information presented was published in a medical literature article in npj Vaccines, a Nature Partner Journal. The findings in the June 21 article reported a follow-up study of people with established type 1 diabetes (T1D) treated with the bacillus Calmette-Guérin (BCG) vaccine, which evaluated the impact of the intervention and provided a hypothesis to support the notion that BCG vaccination could be beneficial for people with T1D.

While this work has attracted attention, the study only followed a very small number of patients—nine people at the five-year time point, and three people at the eight-year time point—and must be interpreted with caution.


Overall, the findings prompt thought-provoking questions but not definitive answers, and do not provide enough clinical evidence to support any recommended change in therapy at this time. Specific limitations that should be considered include:

  • All study participants continued to use standard insulin therapy throughout the trial; it’s not a situation whereby the treatment changed their standard of care (all vaccinated individuals remained on insulin therapy).
  • The patients with reported positive outcomes achieved only moderately lower A1Cs, which, while marginally statistically significant, cannot be generalized to the millions of people living with T1D and is not established to be as a result of the vaccination.
  • The article doesn’t account for the natural variability in A1C levels over time, which is well known to occur in this population: they tend to improve in people with T1D as they age, particularly as they move out of their teens and early 20s. It’s unclear what role that natural history may have played in these subjects.
  • There is no detail on the standard of care in the BCG treated and control group. For example, was the care comparable between both study groups or were adjunctive therapies used?

JDRF and ADA do not currently fund Dr. Faustman’s work. We will be monitoring the progress made by Dr. Faustman and want every researcher in our field to be successful. Both organizations employ rigorous, peer-review processes to make evidence-based funding decisions, and we will continue to focus our resources on projects that we believe give us the best opportunity to create a world without T1D—for ourselves and our loved ones—as fast as we can.

source: JDRF

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Mimi
Mimi
3 years ago

These criticisms can be made of any T1D research. They’re too proud to admit that they were wrong. The truth is that there’s no money in it for the diabetes industry, but who cares about truth in this country any more.

Shaun
Shaun
2 years ago
Reply to  Mimi

Faustman’s research is now fraudulent at best. The key claim is a 10% reduction in A1c over a five year time period after two initial injections of BCG, timed two weeks apart. Insulin is still required and there is no mention of other factors that could easily account for the .7% drop in A1c over five years. A study with 3 patients? I’m T1D and I badly wish this to be a cure but the sad reality is that it’s a money grab, not a cure. They are projecting 20 million in costs through their fund-raising efforts to administer BCG… Read more »

Rick Phillips
Rick Phillips
3 years ago

I do not usually agree with the ADA on such issues, but this time I 100% agree. Isn’t it odd that about this time every year she cures T1D only to cure it again next year. Sorry this looks like much ado about nothing.

Ivan
Ivan
3 years ago

Why would the ADA and JDRF not want to look into her research more? Because the ADA and JDRF are infiltraited with FDA and Big Pharma coworkers. Type 1 diabetes is a money making disease for BIG Pharma and they do not want their business friends and their lively hood too be hurt.

Dawn
Dawn
3 years ago
Reply to  Ivan

That is so true. This why I do not financially support ADA or JDRF. They focus on Type 2 verse Type 1. They do NOT fund enough Type 1 research.

Patrick McFeeley
Patrick McFeeley
1 year ago
Reply to  Dawn

JDRF funds more Cure related T1 research than any nongovernment organization in the world. They also fund more research that is improving the lives of those living with T1D than any other. They do not focus on any research specific to T2 as you have stated. Some of the research does benefit the T2 population. JDRF has looked closely at this research and decided at this time not to fund. If more convincing evidence shows promise they will continue to consider funding in the future. At this time the results do not warrant funding.

T1D Indentured Servant
T1D Indentured Servant
3 years ago

What a surprise! These organizations don’t want the punch bowl taken away. At any rate, why even consider an opinion by these folks who commit so little of the money they raise to actual research. The real question one should ask is how it’s possible over the last few decades, that we’re still talking about insulin injection and goofy insulin pumps? They’re primitive and barbaric!

Megan
Megan
3 years ago

JDRF isn’t interested in a cure. They’re only interested in palliatives. This is disappointing but not surprising.

Russ
Russ
3 years ago

of course it does not bring BILLIONs in profits to big pharma.

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