I researched the study that Faustman is starting, and the press coverage of it. Here is my summary of it:
1. This is NOT a study aimed at testing a cure for diabetes!
2. it involves about 25 patients, and will last for 3 months.
3. The goal is to use their equipment to measure changes in the immune system, when patients are given BCS. They don't expect any change in insulin or BG.
4. The BCS dose that will be used is exactly the same dose currently used in certain vaccines, and has been studied in the past as possible type-1 cure.
The best possible outcome of this study, is that they could learn enough to start a new, different study of a possible cure for type-1. Remember, these guys just spent about 10 million dollars (from JoinLeeNow) mostly on some custom made, super-sensitive, measuring machine. In my opinion, this study is designed to make sure that machine works, and can be used in a clinical setting.
Here are my thoughts on Faustman's research:
1. Lots of things cure type-1 diabetes in mice, that do not cure it in people. My experience is that twice a year a new method is found to cure type-1 in mice, and this has been true for at least 4 years now. None of these things has panned out for people. So the fact that she has cured type-1 in mice is nice and necessary, but not very important. Lots of people have done that.
2. Faustman is just starting her first Phase 1 study. Several groups are at that phase, or slightly ahead of her. LCT, for example. They went into phase-1 last year, and have great results, although on a tiny number of human subjects. Still a tiny number is much better than none.
3. If you really want to look at a group with experience curing type-1 in people, the Diamyd guys are just starting a Phase-3 trial, and there are a some in phase-2 (TolerRX, and it's twin brother, Macrogenetics) Transition Therapuetics, and so on.
4. One of the reasons that Faustman sounds so good, is because she has never done anything with people. Therefore, she can say "no side effects", "works instantly", "cheap", "cures completely" etc. She has no real world experience to show otherwise. Now the Diamyd guys have done both phase-1 and phase-2 in people, so the limitations of their cure are well known, so it sounds much worse than Faustman's. But (for me) that is because they have human experience, not because it actually is worse.
5. Guessing about one particular line of research, is just that: guessing. And it is hard and error prone and ultimately not very rewarding. However, I'm going to guess. My guess is that Faustman's current research does not lead to cure for type-1. I'll go farther than that. I think that this phase-1 trial will not result in any improvements to the children who take part. To be specific, the insulin use of the kids in the study will change less than 10%. However, Faustman will announce (with great fanfair) that her own special super-sensitive equipment has found a difference, and the experiment is a success. However more tuning is needed to make it a real cure, and somehow that tuning will never get done successfully.
Why do I believe this? Lots of reasons:
A. BCS has been given to millions of people for other reasons, and follow up has looked at type-1 specifically, and it has never been seen to prevent or cure type-1.
B. BCS has been studied specifically to prevent/cure type-1 diabetes, and has never been shown to do so. (Although never at the exact dose Faustman is using.)
C. BCS is well known to cure type-1 in mice, exactly what Faustman sees, and taking away her reason for optimism, since others already tried this in mice where it worked, and people, where it failed.
D. Faustman was wrong about the spleen cell part of her experiment. Dead wrong. This does not prove she is wrong about the current work, but it leads me to believe that she is overly optomistic and does not understand her own experiment completely. (But a lot of research is based on things not completely understood. Who researches what is already well known?)
I'm sorry to sound so down, and actually, I'm not down on cure research. But I think it is much more likely to come first from one of the other players, rather than Faustman. One of the real problems with information on cures, is that we tend to get it via press releases, and each research group issues a press release when they do something good. And the press just discusses just that one group, so there is little sense of comparison of the pros and cons of different research. I'll try to update my page soon, because that is what I was trying to do with it.
I'm curious to know what you thought of Denise Faustman's work? She is working under Lee Iaccoca's diabetes cure foundation. I thought they were doing some human trials as well.
Faustman's work is listed on my page, because Nathan is going to start human trials
by the end of this year (they expect).
You are asking for my personal opinion about Faustman's work, and I will give it, but
I will choose my words very carefully, because I know her work has generated a lot
of emotion, and I have thought about this topic quite a bit. I expect the list owner
will ask to end this discussion if it becomes too off topic, which it might. Faustman's
research is complex
As background I want to say that in the past I have donated money to both JDRF
and Lee Iaccoca's foundation; both to try to cure diabetes.
The one thing that I am absolutely sure of is that the problems outlined by other
researchers who questioned Faustman's work were absolutely correct. They felt
the spleen cell part of the work was wrong, and all three groups that tried to
replicate the experiment found that the spleen cell part was wrong. They used
techniques that Faustman did not use to show in detail how wrong it was. The
JDRF should be proud of it's technical review process. They were right on in this
case.
Now Faustman can still claim that her approach worked even without the spleen
cells, and the replication experiments worked to (also without the spleen cells helping).
More over she can claim that without the spleen cells it is a simpler process, so
Nathan's soon to be human trials will be even closer to a cure! I am very doubtfull.
The other parts of her possible cure have both been tested before and found to
work in mice and fail in humans. It was the spleen cells that were novel, and that
is the part that was clearly wrong. Now Faustman can say (truthfully) that her
experiments used different dosing of the previously used techniques, so hopefully
her stuff worked because of this different dosing. If this turns out to be the case,
then her work can lead to a cure. But I'm doubtfull.
I guess my summary is this: Diabetes is full of unknowns. We don't know the cure
so we don't know where it will come from. However, of the trials that I list, I think the Faustman/Nathan research is in the BOTTOM third in terms of likelyhood of success.
Two thirds of the other trials are more likely to lead to a cure quicker.
I don't have time to write a full post, but when I saw Lisa's quote (below) I suddenly realized why so many people like Faustman's work!
Lisa wrote:
"For me, there is one cure in the works. That is at Dr. Faustman's lab. Since there is nothing really compareable to what she is doing, she will be the first."
The "advantage" of Faustmans work (and I mean that most sarcastically) is that SHE HAS NEVER DONE ANYTHING WITH PEOPLE. She has never cured anybody, she has never even tried to cure anybody! She has not even raised a single person's C-peptide generation or lowered insulin usage. Therefore, she can say anything, and some people will believe her. She can say her research is a cure! Is cheap! Has no side effects, works by magic! Solves the real problem. Whatever. Because she's never treated one person, there is no pesky data to show any problems in her work.
The "problem" (again, sarcasticly) with Dynamid Develogen and all the rest, is that they have done trails on people, so we know the weaknesses of their research. (Because Faustman hasn't done human trials, we don't know the weaknesses of her research.) Maybe this is the real reason why the first thing she did after getting her 10.6 millon from Lee, is to delay human trials by two years! As long as she doesn't test anything, her research will continue to be perfect!
On a slightly more serious note, Lisa, Faustman's big human trials will be testing BCG. BCG has been previously tested as a type-1 cure and as a type-1 prevention. It did neither. Faustman's only unique component is going to be different dosing. Same drug different dose. Seems like a long shot. Hopefully in 2011 when we finally hear about it, it will be redundant.