Tuesday, September 11, 2012

JDRF Funding for a Cure 2012

In the US, we are starting the "Walking Season" when JDRF asks us to walk to raise money for cure. So I'd like to do my part, by reminding you all how important JDRF is to the human trials of potential cures for type-1 diabetes, which I track.

Let me give you the punch line up front: 63% of the treatments currently in human trials have been funded by JDRF. (And the number is  66% for the later phase trials) This is an strong impact; one that any non-profit should be proud of.

This summary does not include Artificial Pancreas research or stem cell trials, which I discuss separately.  The list is a list of treatments, not a list of trials.  For example, the "ATG and autotransplant" treatment is actually running three trials, but since they are testing the same treatment, it is only one item in the list.  DiaPep277 is running several trials, Rituximab has two, and so on.  Finally, those treatments marked "(Established)" have at least one trial which is open to people who have had type-1 diabetes for over a year.  So those are open to non-honeymoon diabetics.

Also remember that I give an organization credit for funding a treatment if they funded it any any point in development; I don't limit it to the current trial.  For example, JDRF is not funding the current trials for DiaPep277, but they did fund much of the early research into it, which allowed it to grow into human trials.

Cures in Phase-III Human Trials
Summary: there is only one treatment in phase-III right now, and it has been funded by JDRF.
  • Andromedia's DiaPep227 
This treatment has more than one study active right now.

Cures in Phase-II Human Trials
Summary: there are 14, and 9 of them have been funded by JDRF, either directly or indirectly through ITN. Here are the treatments that have been funded by JDRF:
  • Abatacept by Orban at Joslin Diabetes Center
  • Diabecell by Living Cell Technologies    (Established)
  • Exsulin (previously INGAP) by Exsulin    (Established)
  • Kineret / Anakinra by Mandrup-Poulsen at Steno Diabetes Center
  • Rituximab by Pescovitz at Indiana
  • Sitagliptin and Lansoprazole at Sanford Health
  • Thymoglobulin (also known as ATG) by Gitelman
  • Umbilical Cord Blood Infusion by Haller at University of Florida
  • Xoma 52 by Xoma Corp  (Established)
Not funded by JDRF:
  • ATG and autotransplant by Burt, and also Snarski, and also Li
  • Atorvastatin (Lipitor) by Willi at Children's Hospital of Philadelphia
  • Brod at University of Texas-Health Science Center
  • Canakinumab by TrialNet
  • NI-0401 by NovImmune

Cures in Phase-I Human Trials
Summary: there are 23, and 14 of the are funded by JDRF and 9 are not. Here is the list funded by JDRF:
  • Alefacept by TrialNet
  • AAT or Alpha-1 antitrypsin by OmniBio and also Kamada
  • ATG and GCSF by Haller at University of Florida    (Established)
  • BHT 3021 by Bayhill Theraputics   (Established)
  • CGSF by Haller at University of Florida
  • Trucco at Children’s Hospital of Pittsburgh    (Established)
  • IBC-VS01 by Orban at Joslin Diabetes Center
  • Leptin by Garg at University of Texas
  • Nasal insulin by Harrison at Melbourne Health
  • Polyclonal Tregs by Gitelman at University of California San Francisco
  • Pro insulin peptide by Dayan at Cardiff University
  • Proleukin and Rapamune by Greenbaum at Benaroya Research Institute    (Established)
  • Lisofylline by DiaKine
  • Stem Cell Educator by Zhao (Established).
Not funded by JDRF:
  • BCG by Faustman at MGH (Established)
  • CGSF and autotransplant by Esmatjes at Hospital Clinic of Barcelona  (Established)
  • Encapsulated Islets at University clinical Hospital Saint-Luc    (Established)
  • Etanercept (ENBREL) by Quattrin at University at Buffalo School of Medicine
  • GABA by Lunsford at the University of Alabama at Birmingham.
  • Monolayer Cellular Device (Established)
  • Rilonacept by White at University of Texas
  • The Sydney Project, Encapsulated Stem Cells (Established) 
  • Pioglitazone by Wilson at Stony Brook 
Summary of all Trials
38 in total
24 funded by JDRF
So  63 % of the human trials currently underway are funded (either directly or indirectly) by JDRF. Everyone who donates to JDRF should be proud of this huge impact; and everyone who works for JDRF or volunteers for it, should be doubly proud.

Just Looking at Trials on Established Type-1 Diabetics
13 in total (34% of all trials)
8 funded by JDRF
So 62% of the trials recruiting established type-1 diabetics, are funded by JDRF.

Compared to Last Year
In 2011 there were 37 treatments in clinical trials, in 2012 there are  38  (growth of 3%)
In 2011 there was 1 treatments in Phase-III trials, in 2012 there is still  1  (no change).
In 2011 there were 16 treatments in Phase-II trials, in 2012 there are 13  (drop of 23%).
In 2011 there were 20 treatments in Phase-I trials, in 2012 there are 23 (growth of 13%).

In previous years I have included some drugs that were basically being tested as treatments (adjuncts to insulin that would give people better control or help them use less insulin).  This year, I have removed those from the list.  I included them before because there was always a chance they would lead to a cure.  I'm now of the opinion that was wishful thinking, so I'm no longer including them here.

How I Count Trials for This Comparison
  • I give an organization credit for funding a cure if it funded that cure at any point in it's development cycle.
  • I mark the start of a research trial when the researchers start recruiting patients (and if there is any uncertainty, when the first patient is dosed).  Some researchers talk about starting a trial when they submit the paper work, which is usually months earlier.
  • For trials which use combinations of two or more different treatments, I give funding credit, if the organization in the past funded any component of a combination treatment, or if they are funding the current combined treatment. Also, I list experiments separately if they use at least one different drug.
  • The ITN (Immune Tolerance Network) has JDRF as a major funder, so I count ITN as indirect JDRF funding.
  • I have made no attempt to find out how much funding different organizations gave to different research. This would be next to impossible for long research programs, anyway.
  • Funding of research is not my primary interest, so I don't spend a lot of time tracking down details in this area. I might be wrong on details.
  • I use the term "US Gov" for all the different branches and organizations within the United States of America's federal govenment (so includes NIDDK, NIAID, NICHD, etc.)
  • I don't work for the US Gov, JDRF, or any of the other organizations discussed here. I'm an adviser to JDCA. I also own stock in several of the companies discussed here.
This is an update and extension to blog postings that I've made for the previous four years:

Please think of this posting as being my personal  "thank you" note to all the JDRF staff, volunteers, and everyone who donates money to research a cure for type-1 diabetes:
Thank You!

Finally, if you see any mistakes or oversights in this posting, please tell me!  There is a lot of information packed into this small posting, and I've made mistakes in the past.

Here is a chart of the number of total clinical trials, and broken down by phases, for each of the last few years:

Joshua Levy
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions.  My blog contains a more complete non-conflict of interest statement. 
Blog: http://cureresearch4type1diabetes.blogspot.com
Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/


U can succeed ! said...

Thanks for all you do. But I have one huge problem and I notice most people are afraid to expose the JDRF on this point. Treatments are not cures and treatments do not lead to cures. We treat chicken poxs, polio and a host of other disease but none of this has lead to a cure for these diseases. I strongly believe the JDRF would not get as much funding if they would truly advertise events in this manner, walk to raise money for the AP or walk to raise money for better treatments. However their marketing schemes misleads people. Again they are not even funding some like http://www.isletmedical.com/ They do not spend as much money funding a cure as they should.

James said...

Hi – Will you please post a link to your important Blog at The Type 1 Diabetes Community at vorts.com? Our members will really appreciate it.
Members include: Those living with Type 1 Diabetes, their families, friends, experts and support groups.
It's easy to do, just cut and paste the link and it automatically links back to your website. You can also add Articles, Photos, and Videos if you like.
Email me if you need any help or would like me to do it for you. I hope you consider sharing with us.
The Type 1 Diabetes Community: http://www.vorts.com/type_1_diabetes/
James Kaufman, Editor

Joshua Levy said...

This is my response to "U can succeed":

When it comes to research, JDRF spends about 60% of it's money on a cure, about 20% on complications and about 20% on better blood glucose control. Artificial pancreas work, which gets a lot of press, is a subsection blood glucose control, and is something around 3% of the total. All of these numbers are approximate, both because they change slightly from year to year, and because I'm working off memory.

Now you seem to have four questions/issues, but I only have space for three comments:

1. JDRF's marketing misleads people into thinking that they spend more money on cure research than they actually do.

Well, when I look at the JDRF web page, this is the logo at the top (the bolding is in the original):
JDRF. Improving lives. Curing Type 1 Diabetes.
I think that is completely consistent with an organization that spends 60% on cure research, and 40% on other research ("improving lives").
If I pull down their research tab, there are several items there, three of which are: Cure. Treat. Prevent.
Again, I think this completely consistent with how they spend their money.

I think the best way to evaluate JDRF's messaging is to look at everything that they publish. One common mistake people make is to look at one press release or one piece of marketing literature and say "this piece talks too much about X or not enough about Y". But the proper thing to do is to look at everything they produce.

I just took a look at the 10 most recent JDRF press releases (right side of the home page). They cover a wide range of topics, including basic research, research focused on a cure, research focused on treating complications, etc. I don't think anyone reading all those press releases could possibly get the idea that JDRF is a cure only sort of organization.

2. They don't spend as much money on cure research as they should.

The real question is how much "should" they spend on cure focused research? To be blunt: whatever your answer, it's your opinion. You're entitled to your opinion, but it's a big mistake to think that everyone has the same opinion as you, or that JDRF is wrong because they have a different opinion. Personally, I agree that JDRF "should" spend about 70% on cure research. Does that mean it's wrong if they don't? What if someone else thinks JDRF "should" spend about 50% on cure research? Are they wrong if they do what you want? What I want? What he wants? You're putting JDRF is an impossible situation, because there is no widespread agreement on much money "should" go to cure research compared to BG control or treating complications.

4. Research aimed at preventing type-1 diabetes will not lead to a cure, so should not be funded as part of a cure.

Certainly many people believe this is true, and it might be true. Others don't think this is true. Do not mix up what many people believe with a proven fact.

You give several examples where success in prevention has NOT led to success in cures. All of these examples are viral diseases. It may be true for viral diseases, but not true for an autoimmune disease like type-1 diabetes. Unfortunately, I know of no autoimmune disease which has been cured or prevented, so we just don't know for this class of diseases. For allergies (for example), research into prevention has been helpful to developing cures (and visa-versa). And I would argue that allergies are closer to type-1 diabetes then viral diseases, since (like type-1) involves a misbehaving immune system.

I would never say that research into prevention will lead to a cure.
But I think it is equally wrong for you to assume that research into prevention will never lead to a cure. We just don't know.

It is perfectly reasonable to say "I don't think research into prevention will lead to a cure". But not to assume as fact that research into prevention will never lead to a cure.

U can succeed ! said...
This comment has been removed by the author.
U can succeed ! said...

Joshua, the Jimmy V uses all of its money for a cancer cure not treatments. It is not my opinion it is truth. I am sure if people were allow to state EXACTLY where they wanted their money to go, a whole lot more would go to "cure" funding. Why does the JDRF not give people this option? Why are people so afraid to point out the faults of the JDRF. I mean it is okay for people to be critical of everything else ie in this political year and want change what is wrong with wanting the JDRF to change? The JDRF recently change it take line to make cure secondary. If the JDRF was not the biggest player in the type 1 arena I would not care about how they spent their money I only care because I want to see more money about 85 to 90 % spent for cure research. Again I bet if the JDRF make public or allow people to send funds for cure. you would see more money going to a cure. Let me ask you this if a device you order said it would play blue ray disc and DVD and you got it home and it did not play certain DVDS what would you say. Would you say that's okay it only plays 60 percent of my 1000 DVDs. No you would go back to the store or want to know why it does not play all of you DVDs. They say to you, well we felt it best it only played certain DVDS and not all. Would you say that is okay I only wanted to watch some of my DVDs. No you would want to watch all of your DVDs or a large majority. Also as for the treatment and cures, let be honest once a treatment is found, the cost of looking for a cure - looks far more expensive. Why because, the disease or condition itself will eventually be gone through natural progression. Therefore why would there be a need for a "cure".

LarConBri said...

U can succeed you have a very good point. In addition to that, most significant JDRF fund raising campaigns are clearly named in a way that aims people to believe they are contributing to cure efforts. I cite "walk to cure diabetes", "ride to cure diabetes". Using the "cure" word when raising money and then using part of the money for something else is in my view.

One of my biggest concerns regarding JDRF is their several "partnerships with the industry" in which the JDRF gives money to people like Pfizer, Sanofi, Lilly, Dexcom, etc. This is simply immoral to me, those big multi billion dollar companies should be ashamed to take the money.

This doesn't mean the JDRF is evil or anything like that! they still do a great job, but they should be consistent and more transparent.

Joshua Levy said...

I previously wrote a blog about JDRF's support for big pharma companies in the context of developing an artificial pancreas here:

The most general part of that posting was this quote:
I think that the goal of JDRF should be to speed development of a cure for type-1 diabetes, and if they think the best way to do that is by funding a researcher at a University, great. And if they think the best way is to fund a researcher at a company, great. I don't care where the money goes; I care that it speeds development of a cure.

Obviously there are risks in funding a big company, just as there are risks of funding a university researcher or a non-profit. In my opinion, that doesn't mean we should have a rule never to do it.