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There are several reasons that I have a lot of hope about Dr. Faustman's work.
The first is the logical progression she's followed from the very beginning. If you look at her bio, credentials don't get much better. When she started the islet transplant program at Harvard, it became apparent pretty quickly that it made no sense to give T1's beta cells when the underlying autoimmune process would just attack them again. Remember that Faustman's research has been going on for almost 20 years and all that she's done in that time. And I'm only talking about type 1 diabetes research, not all the other work she's done.
In that time, she identified the T cells that cause type 1. She discovered a defect in them that is not in good T cells that protect us. She exploited that defect -- a fault in the TNF pathway, and learned that she could selectively kill the bad T cells, while leaving the healthy T cells uneffected. The mouse studies showed that the method works. Then, the Faustman team got the added surprise (because they were careful enough to go back and check) that the beta cells regenerated and that transplants weren't necessary. This is one thing that caused the firestorm against her, because up to that point no one believed this could happen though there was tons of evidence that T1s have beta cells -- beta cells are even found in the pancreases of old people who've had T1 since childhood, though they're not in the best of shape.
Faustman showed that the same T cell population that cause T1 in NOD mice exists in human diabetics. She also discovered that the same defect in the TNF pathway exists and can be used the same way to selectively kill them.
Faustman spent years isolating and identifying the T cells that cause diabetes -- no easy task. And they have a huge database of T cell comparisons between diabetics and healthy people. This is crucial in doing any kind of treatment to determine if the underlying autoimmune effect is being stopped. Everyone else takes the easy way out of measuring insulin use, C-peptide, A1c and other indirect measures. Because the process of IDing and counting these T cells is so slow, Faustman developed an automated system to do it. I don't know if anyone understands how impressive that is. She'll be able to point to hard data and show that the T cells that cause diabetes are gone. In addition, she'll also have the same data as everyone else -- insulin use, A1c, C-peptide, etc.
Faustman has shown that the T cells of humans that cause diabetes are killed by TNF just like in mice. All of this is concrete evidence that this will work in people.
But the most impressive thing of all is the method she used to bring this treatment to diabetics. Do you know how much new drug discovery costs and how long it takes? I looked this up the other day. It costs an average of 1 *billion* dollars and takes about 20 years. If Faustman went that route, it would be ages before the treatment were available. In many cases an initial investment of $400 million is made to determine if the new drug will work and often it's abandoned at that stage. You also have to think about the profit potential before a pharma will invest that kind of money. Diabetes is a huge business opportunity. You can buy white papers how how best to make money from diabetes. Billions alone are made from insulin and strips. Complications drugs make tons of money too. Before a company would invest in a cure treatment, they'd have to make enough $$ to make up for the drugs that would be replaced or made obsolete by the new treatment. In the very hypothetical case that a pharma would be willing to develop a new drug for this treatment, even if they charged $20K or more for each treatment as they do for drugs like chemo drugs, they couldn't make up for the lost profit of insulin and other diabetes products.
So, Faustman chose a generic drug that's incredibly cheap all over the world. It induces TNF production and that kills off the circulating bad T cells. There is no reason why this shouldn't work in humans. She meticulously done the work along the way that shows it should. She has to follow the FDA protocol in order for it to come to market. She could've been ready years ago if the foundations and the NIH had funded it. So if you're angry at anyone, it should be them.
Besides the potential to get our kids off insulin, another huge plus to BCG is that it's incredibly cheap in the developing world. There are companies in India that make a vial of BCG for just a few dollars. And every developing nation has it on hand. Kids in many poor countries die shortly after diagnosis, because diabetes supplies can cost more than the family's entire income. A woman I know in Ghana pays as much for strips there as we do here. It's bad enough to pay $1-2 a strip over here -- most people complain bitterly if they don't get full insurance coverage and many people in the States can't afford diabetes care. Imagine if diabetes care cost every penny your family made. Dr. Faustman's treatment can and will save the lives of these children in the developing world who have a death sentence otherwise.
There are many reasons to support her work. Besides all the reasons above, it's the right thing to do. I feel that each of us should choose the research we think is the best and most promising and is the most ethical. The beauty of giving Faustman money is that you know right where the money is going, unlike if you were to give the money to a foundation.
The scientific process is slow. Getting drugs approved for a new use is slow. And raising money from the public for research is a time sink. Dr. Faustman isn't to blame for any of this. We should not turn our back on her. We should realize how important her work is to people all over the world and continue supporting her. She could've taken the easy way out like most diabetes researchers and taken the money from big pharma to run clinical trials for drugs that will never cure diabetes. But she worked hard and risked her reputation for this work. The least we can do is support it.
Sorry for the tome, but this is very important.
On Jun 2, 2009, at 4:15 PM, Karin Espelage wrote:
Sue,thanks for the information. I think what's mostly frustrating is that despite all the work that was done there is still no indication if it actually works in humans or not. That still seems to be up in the air years later. Or did I miss anything? If I understand it correctly then the only concrete result so far is that the solution works in mice and that the drug is safe.I very much hope Dr. Faustman will be proven right about this in the end. However: from what I heard so far I can't tell what the chances of success are. It was ok with me at the beginning to donate to something that might or might not work (I understand that that's the nature of medical research). By now though I had expected to hear some more concrete results (maybe results of a small scale test on a few daring volunteers).Nevertheless: thanks for all your work,Karin----- Original Message -----From: Sue rootSent: Tuesday, June 02, 2009 2:46 PMSubject: Re: [nathanfaustmantrials] Re: cure for type1 diabetes???
Hi Karin
I understand your feelings about the time-line for the Faustman project. However, in reality, the original time-line and goals of the project never changed. Dr. Faustman began seeking funding for the preclinical work and phase I human trial in 2002. The original estimated $11 million for a total of 3 years (18 months of preclinical work and 18 months for phase I) never changed. The rejections and skeptism by the science community and world renowned JDRF organization directly interfered with getting adequate funding to start the project. Even when the Iacocca Foundation launched its "Join Lee Now' campaign in August of 2004, it took almost 2 years to raise the money. Dr. Faustman's lab did not start to get the adequate funding until July of 2006. Eighteen months later, as predicted, the phase I human trial started in January of 2008 and is expected to be finished sometime this July. As you and everyone can see, once the financial support finally got to the lab in July 2006, 3 years later - as originally estimated - the work has been achieved.
I hear your statements all the time and people are wrong when they blame the research as the problem for the delays. We will have the same problem when trying to start phase II of the human trial by the end of the year or early 2010 if we don't get the funding needed.
After following this research since 2002 and raising over $1 million for it with an amazing group of women, every scientific goal has been surpassed thus far and the ONLY thing interfering with its progression is money.
As far as the research in Germany, my opinion is to read the published data and contact the scientists directly to get the correct information.
Sue
--- On Tue, 6/2/09, Karin Espelage <kespelage@hotmail.com> wrote:
From: Karin Espelage <kespelage@hotmail.com>
Subject: Re: [nathanfaustmantrials] Re: cure for type1 diabetes???
To: nathanfaustmantrials@yahoogroups. com
Date: Tuesday, June 2, 2009, 1:15 PM
"..and she told me that these countries do this all of the time - promise American's a cure, only to take their money."Boy, you sure make my native country sound like a shady banana republic! :-) Germany and the EU have very strict regulations for everything related to healthcare. I don't know anything about this clinic but I have a hard time believing that a German hospital just makes total bogus claims on a public website to cheat Americans out of their money...I've been subscribed to this group for a while. I used to donate to the Faustman research regularly. I got frustrated though after the frequent shifts in the promised timeline (and my German relatives whom I asked to donate too now think they've just given their money away to some shady American organization. ..). I understand that human trials are now finally underway. Is there any information about how it's going so far?
Thanks,Karin
----- Original Message -----From: EllenSent: Monday, June 01, 2009 7:35 PMSubject: [nathanfaustmantria ls] Re: cure for type1 diabetes???I don't know about that particular website, but I do know that when my son was first diagnosed with Type 1 diabetes, 14 years ago, there was an article in our local paper for a fund raiser for a six year old who was going to go to Germany to be cured of Type 1 diabetes. I called the mother, and they were going to use islet cells. This was before the islet cell success in Canada. She went there, and was not cured. In fact, her blood sugar control never got better. They claimed that it was because she was too high and under too much stress during the journey to Germany. I spoke to my son's endo about it, and she told me that these countries do this all of the time - promise American's a cure, only to take their money.
--- In nathanfaustmantrial s@yahoogroups. com, "jawad_majed" <jawad_majed@ ..> wrote:
>
> I have come across this clinic in germany ( www.xcell-center. com )They claim that they can cure diabetes 1 and 2 through adult stem cell treatment which sounds simple and cost effective. Any thoughts on this?
>
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