Thursday, March 1, 2012

Possible Cures for Type-1 in the News (Feburary-2012)

Diamyd Publishes Their GAD Failure in Phase-III

Diamyd published a full, peer reviewed article on their phase-III clinical trial.  I don't think there is any new information there, but there are a lot of details to read.  However, I do think there are two lessons to be learned here.  One relates to spin.  Take a look at these headlines:
No Improvement in C-Peptide Levels With GAD-Alum‎
Autoantigen Tx Benefits Some Type 1 Diabetics
Type 1 Diabetes Treatment Disappoints in Trial‎
GAD-alum Antigen Therapy Fails to Halt Progression of Type 1 Diabetes‎ 
They are all actual headlines on different web sites for this same news.  That second one gives the news a different spin, than the rest. In this case, most of the headlines are accurate, but if you happen to see that one "outlier" headline, you will get a very different view of the results.

The second relates to timing.  The timeline for these results are as follows:

May 2011: Diamyd announces that the phase-III trial had failed it's primary end point (press release)
June 2011: Data on this failure presented at ADA 71 (non-peer reviewed scientific presentation)
Feb 2012: Publication in the New England Journal of Medicine (top-flight, peer reviewed publication)

The take home point for me, is that this study went from completion to publication in about 10 months.  Furthermore, this study was (a) very large, (b) negative, and (c) published in one of the most important peer viewed medical publications in North America.  All of these factors would usually make the publication slower.  So I think it is a particularly bad sign when trials are completed but have not published in a year or two or more!

Press Release:

Gardasil Vaccine does not Trigger Type-1 Diabetes

Obviously, this is not cure research, but I know some people continue to be nervous about vaccinations, and the Gardasil vaccine is given during the time when type-1 diabetes is often diagnosed, so this study should provide a lot of confidence that the two are not related.

Basically, a large health maintenance company (which runs both insurance and hospitals) compared their records for people who got Gardasil and people who were diagnosed with type-1 diabetes within 6 months. These records were then double checked "by hand" and compared to similar people who did not get the vaccine.  They looked for many different autoimmune diseases, including type-1 diabetes, and were able to cover a huge number of patient records (about 190,000).  This was a huge study, so it could generate good data even for relatively rare diseases like type-1.

I don't believe that any one study can prove something with absolute certainty, but I do think that this is very well done study, and should carry a lot of weight.

News Coverage:

Personal note: I was reading something about Gardasil, and found a great quote by a cancer researcher.  I didn't save it, so this is a paraphrase from memory:  "For decades, people have been clamoring for a vaccine to prevent cancer.  We finally developed one, but some people don't like it, because it has something to do with sex!"

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.
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