Diabetes Self-Management Blog

Dr. Denise Faustman Read part 1 of the interview here.

In last week’s interview segment, Dr. Denise Faustman talked about the basics of her research. This week, in the conclusion of her interview, Dr. Faustman and Diabetes Self-Management’s Quinn Phillips discuss the controversy surrounding her work and its funding.

Quinn Phillips: Are you surprised — or disappointed — that there is no funding of your research by the National Institutes of Health (NIH) or a similar entity?

Denise Faustman: Well, remember that most drugs in the United States are developed by industry. So what usually happens is people invent in academia, but then those inventions are taken to industry, and after that — only when there’s a finished, polished drug — they come back to academia to be studied in patients. So usually when doctors get recruited to enroll their patients in a drug trial, they don’t have to raise the money — they’re given the money by the drug company. This is a very different project, because this is not a drug owned by a pharmaceutical company; this is a drug that is manufactured by 40 different companies around the world, and it’s readily available. We were pretty naive at the beginning, going to the industry and saying, “Hey, you want to support this drug? What? Money? It reverses disease!” It became pretty obvious that you have to have an economic model for industry to partner with you — you have to have something that’s unique that they can make their money from. And if you don’t have that, then industry has no interest in moving it forward. It’s just the brutal truth, you know. A company can’t have a loss of a billion dollars and not have anything to sell.

NIH money, historically, isn’t available for Phase I trials such as ours, and often a lot of NIH money is paired with industry money so that they get a bigger bang for their buck. NIH does a lot of these industry trials. So we don’t like to think about good guys and bad guys, but the real good guys here are people who donate to this program directly to see it move forward. And we aren’t hampered by the typical things that hamper clinical trials, like someone saying, “You have to use this drug, but guess what — you can’t study these patients in this way or that.”

QP: Using NIH money — taxpayer money — to develop a drug from which a company will reap enormous profits seems like corporate welfare to a lot of people. Do you think there are valid reasons for this system?

DF: I think that when you can leverage studies — let’s say you’re a government employee and you have $20 million, and someone else comes in and says, “I’ll give you $40 million, and we’ll do it together” — it looks good. And that’s the typical way drugs are developed. So when somebody comes along with the exception and says, “Hey, I’ve got this cheap thing,” it’s kind of a new paradigm — we’re breaking new ground. And also, a lot of the government programs are set up for only new-onset diabetics. That’s where all the for-profit drugs are being developed. So half the money for clinical trials we can’t even apply for, because we’re actually trying to reverse diabetes in people who have it. We’re excluded.

QP: Do you see that changing?

DF: I think once we start getting real data, things will change. But nothing in the government moves fast. We actually hope that things change in a broader sense, that people should be taking on the bigger conceptual projects and not just trying to give a new-onset diabetic a small difference in pancreas function for a week or a month. They should really be tackling the tough scientific questions of what to do for people who have the disease, other than new glucose meters, etc. So if anything, we hope our work sets a new paradigm that people with the disease should not be left out of innovative therapy.

QP: Given that you rely on philanthropic support, were you surprised by the JDRF’s reaction to your work [circulating a very critical e-mail, funding replication of the mouse study by other scientists, and then denying funds for human trials]? [Read more about the JDRF and Dr. Faustman here.]

DF: Yeah. I mean, a lot of foundations — and the JDRF is not alone — sponsor for-profit clinical trials, and they take an equity position in them to help raise money in tight times. So we were shocked by that, but we got back on our feet and are raising money. So in that sense it was disappointing, but we’ve moved on from there, and I think the public recognizes the validity of trying to do these types of trials in people who have the disease. It’s not a new glucose pump, meter, etc., but actually trying to restore function long-term in a pancreas. So we’ve been very fortunate regarding the public’s support.

QP: Is it useful to fund duplication of experiments, as the JDRF did with yours?

DF: Sure, all science needs to be duplicated. What you would hope they would do, of course — instead of pouring $5 million into the duplication — would be to then fund the trials. That’s where they stopped, but we kept moving. Disappointing, but we’re moving on.

QP: Do you have anything to say about the drug Gleevec, which was mentioned in a recent press release of yours? [Gleevec has been used to treat diabetic mice in industry-funded studies — read more about it in the blog post "Cancer Drugs Reverse Type 1 Diabetes in Mice".]

DF: The studies are still at a little bit earlier stage. What people do when they evaluate these studies — when mouse doctors evaluate these studies — we look at three things: Does it work in a prediabetic animal? Does it work in a recent-onset diabetic animal? And does it work in a severely diabetic animal? Those studies show that it works in prediabetic animals and animals with just one blood sugar reading of 250 mg/dl. The data is not out there yet on whether it works on fully diabetic or long-term diabetic animals.

QP: Do you worry that because of the profit motivation for Gleevec, their research will catch up with yours?

DF: Well, it will be sponsored by the drug company, so it will fit the very common paradigm of drug development in the U.S. — that the company that owns that drug is going to develop it and pour money into it. If we thought we might lose money from that company, then we’d be worried — but we’re not getting money from that company now, so it’s OK. And I’m also of the thought that you want every approach moving forward as quickly and aggressively as possible, because we’re not at the golden gates yet with everything working — barely anything is working! So you’d better hope a lot of different approaches are moving forward.

QP: When will your Phase I human trials be over?

DF: About [15] months from now. So that’s really fast — most Phase I trials take five years or so; we’re going to be about two-and-a-half years.

QP: Is there anything else you’d like to tell the readers of Diabetes Self-Management?

DF: We’re working to reverse disease in people who already have it; that’s kind of unique. And we’re working with a generic drug that has the most impeccable safety record of any vaccine in the history of the world. So we can move pretty fast. And the project is totally supported by the public — it’s philan
thropic.

QP: Are you still soliciting donations?

DF: Oh yes, we’ve got to raise money for Phase II! And if people want to register on our Web site for an interest in participating in the trial — obviously we have a lot of people interested — we take all their information down.

For more information about Dr. Faustman’s research, visit www.faustmanlab.org

POST A COMMENT       
  

Comments
  1. I love Dr.Faustman. She is my Hero. My daughter has Type 1 Diabetes. Diagnosed at 12 yrs. old. She is 26 now. Her health is on the down side. Diabetes has raveged her body. She has bouts of kidoasidosis, I’ve seen her fingernails fall off. She goes from having the most volumtious body, to a bag of bones. She wakes in the morning with / bouts of hypoglycemia. SCARY!!! When she was first diagnosed, she a team of specialist, she still needs them; but has had no access to these guys since turning 18. 7 yrs for a Type 1 Diabetic with no specialized care has really taken a tole on her body. We have been searching & researching, come up with lots of hopefuls.

    Dr.Faustman is a Blessing for all of us who has a family member efflicked with Type 1 Diabetes. I watched my Father die when he was just 48 from complications of Type 1. I have been seeing alot of the same familiar symptoms in my daughter.

    The cure has been found, Thank you Dr. Faustman & Godbless you. It it is even more realistic & reachable than any of us could have imagined. It is mind-blowing.

    The body healed itself, after being treated with the proper antidote. SIMPLY!!! WOW!!!

    I’ve been devouring every piece of information I can about all of this.

    I see it coming for my daughter & others like her. I see that this is the real deal that she & I have been on a mission for yrs now.

    She is also sick, & I will do anything to get her under Dr. Faustman’s care, trial, etc. I have no doughts in my heart, this is our ticket…

    Posted by karisue |
  2. To all Dr faustman supporters , you could help free speed up the funding of Dr. Faustman’s most promising research:

    A) to reverse type 1 diabetes
    B) at cheap price (generic BCG)
    c) with the safest approach (long history of safety use)

    How: You can join the lobby group newsletter totally free at http://www.hdiabetes.com
    It’s free to join. We will be stronger in group.

    Spread the word about the lobby group. We will fund the research fast.

    Thank you

    Posted by Hdiabetes |
  3. I see that the previous blog was posted in 2009. Any idea how much closer the studies have come to a cure in humans? I have had type 1 since I was 14 now I am 25 and will be kicked off my mother’s health insurance when I am 26. Trying to get a part time job in a hospital but I really want to work as a diabetes educator I’m just afraid of staying in school to finish the necessary courses and losing my health insurance. Double edged sword. Maybe if Faustman’s cure in mice were able to work in humans I wouldn’t have to worry so much about my disease and go to school to be a veterinarian :) Also curious, does the American Diabetes Association support Faustman’s work? They seem like they go to great lengths to find a cure. I hope they support all avenues as well.

    Posted by Sarah in FL |

Post a Comment

Note: All comments are moderated and there may be a delay in the publication of your comment. Please be on-topic and appropriate. Do not disclose personal information. Be respectful of other posters. Only post information that is correct and true to your knowledge. When referencing information that is not based on personal experience, please provide links to your sources. All commenters are considered to be nonmedical professionals unless explicitly stated otherwise. Promotion of your own or someone else's business or competing site is not allowed: Sharing links to sites that are relevant to the topic at hand is permitted, but advertising is not. Once submitted, comments cannot be modified or deleted by their authors. Comments that don't follow the guidelines above may be deleted without warning. Such actions are at the sole discretion of DiabetesSelfManagement.com. Comments are moderated Monday through Friday by the editors of DiabetesSelfManagement.com. The moderators are employees of Madavor Media, LLC., and do not report any conflicts of interest. A privacy policy setting forth our policies regarding the collection, use, and disclosure of certain information relating to you and your use of this Web site can be found here. For more information, please read our Terms and Conditions.


Flashpoints
Screen Time (07/16/14)
School Lunch Showdown (07/09/14)
Fruits, Veggies, and Weight (07/02/14)
Higher Fat, Lower Glucose? (06/25/14)

 

 

Disclaimer of Medical Advice: You understand that the blog posts and comments to such blog posts (whether posted by us, our agents or bloggers, or by users) do not constitute medical advice or recommendation of any kind, and you should not rely on any information contained in such posts or comments to replace consultations with your qualified health care professionals to meet your individual needs. The opinions and other information contained in the blog posts and comments do not reflect the opinions or positions of the Site Proprietor.


Blood Glucose Self-Monitoring — Part 1: The Gear
Blood glucose self-monitoring is one of the keys to diabetes control. Here are the tools you need to carry out this task.

Perfectionism: An Impossible Goal in Diabetes Management
Striving for good self-care is important, but perfectionism can make diabetes care — and life — more difficult.

Recipes for Spring
Enjoy recipes for Baked salmon on beet greens, Tofu and snow pea slaw, Radish and cucumber salad, Spinach pinwheels, Beet salad with citrus dressing, and Stuffed berries.

Complete table of contents
Get a FREE ISSUE
Subscription questions