If you can't cure it, prevent it!

Lately there has been some news from a unexpected source regarding the upcoming Diamyd (GAD65) prevention trial. We have been expecting news on the NIH TrialNet funded prevention trial expected to start in mid 2009, instead news from two independent sources have said to be interested in starting one prevention trial in Scandinavia and one in Sweden, pending approval from the medical agencies.

Now we are awaiting three prevention trails with Diamyd (GAD65) to be started in the first half of 2009.

1.
NIH TrialNet, USA
Lead: Jerry Palmer / Ellen Leschek
Status: Planned, waiting FDA approval
Start date: mid-2009

2.
Lund University, Sweden
Lead: Helena Elding
Status: Approved from ethics committee, pending approval from medical agencies
Start date: mid-2009

3.
Scandinavian Prevention Trial
Lead: Unknown
Status: Unknown
Start date: 2009

Why prevention? Well it looks like the largest problem is not to halt the beta cell destruction, but to regenerate the beta cells. So stopping the assault before all or any beta cells have been destroyed is the key point here (until we have solved the beta cell regeneration problem).

BIG problem with prevention is that 90% of all type 1 diabetics have no relatives and no real reason to suspect that they might be at risk. You cannot simply vaccinate the whole population (well you could, but you wouldn't because it's not practical/safe). The three prevention trials above will solve this in slightly different ways. NIH TrialNet will take patients with high risk from their Natural History Study. The Swedish trial from Lund University will use its database of all children born in southern parts of Sweden (ABIS) to pick the children with high risk (2-3 antibodies).

It's still hard to see how this will play out. So far all prevention trials have more or less failed. Is there any reason to be optimistic? Maybe. The Diamyd vaccine can either not work at all, delay the outbreak of type 1 diabetes, or fully stop the outbreak (cure). No one can claim to know what the outcome in these trial will be, since then you wouldn't have to spend years doing them.

Of course it's the effect seen at newly diagnosed (Phase II trial) which has prompted these trials. You also have to note that the sub-group which really benefited (diagnosed <3 months) was only 4 individials. Now Phase III trials with 640 patients will try and verify those results.

The trials are likely to last for at least 5-10 years. They will probably be read yearly and results should be visable after 4-5 years depending on the group size.

So who is this for, people who already have the decease will not benefit, and people who doesn't know they are at risk won't know to care. I would say this news is mostly beneficial to families who know that their children are at a greater risk (siblings/parents/cousins already have the decease). They might have the possibilty to reduce or eliminate the risk by a simple vaccination, if it proves to work.

Safety is the word! Since vaccination will probably mean that 90-95-99% of all people receiving the drug won't need it, it has to be safe! Sure a sick kid might accept getting the flu and being at a hospital for 1 week if it improves his diabetes, but a healty kid will for sure not, and should't have to. The absence of side-effects is the important silent benfit of Diamyd (Gad65) (So far!).

Too good to be true some might think, and after 30 years of failiures I can't blame you. But what more can we do than to support research and hope it works. After all, the last 10 years of medical research have been one break through after another. Time for Diabetes now.

Will a successful vaccine against type 1 diabetes kill off all research in a cure to current diabetics? This fear is something we as a community must address and make sure that the research never stops.