It feels like the last nine months have been one let down after another in diabetes research. In early October 2010, Macrogenic’s AntiCD3 protocol, called Protégé, did not meet its endpoint and was terminated in December 2010. In March 2011, the other Anti CD3 trial through Tolerx, called Defend -1, also did not meet its endpoint and was suspended for further review. On June 1, it was announced that Diamyd’s GAD vaccine trial did not meet its endpoint and in a quick reaction, Diamyd’s stock plummeted 83% on the NASDAQ.
A couple of weeks ago, I was invited to hear Dr. Kevan Herold, professor of immunology and of medicine; deputy director of translational science at Yale University, talk about his concept of humanized anti-CD3 monoclonal antibody, and the study of the metabolic and immunologic effects on the disease process. To open the research update, we had a patient of Dr. Herald who participated in the trial and for 3 years lived on a few units of Lantus and nothing else, which is the reason Anti-CD3 made it to phase 3 trials. There was enough success to warrant further study! But someone from the audience laid into Dr. Herold, “For all the money spent, I would assume you would have known this wasn’t going to work!”
So what happens when research fails to produce the results? Do you think it is wasted time and money to find out that it’s not the cure?
Many patients and caregivers hold JDRF accountable for not having found a cure, but I believe that what has been discovered through failed research is that we know so much more about the human body and the extremely complex elements that form diabetes. A friend of mine said it best, “Better something fail and fail quickly so we can learn from it and move on.” Move on doesn’t mean that the information extracted from research has no value!
The amazing human body is made up of millions of cells and each body has it own unique markers, so science has a big job to try and figure out how to create a universal cure. Forty years ago, JDRF was founded because of one doctor’s comment that “if we can kill the infection that causes diabetes, we can cure the disease.” And he thought a million dollars would do the trick.
Dr. Herold commented that the failure of the anti-CD3 trials showed researchers a unknown element, or hole, in what they know about diabetes at the time of diagnosis. The task now is to continue to work on anti-CD3 and find the hole in the research that is the unknown element for newly diagnosed patients, in his mind that could be the element to stop the progression of the disease.
I don’t think JDRF needs to apologize for saying they are working toward a cure, because looking for a cure is studying the minutia of the disease. While we have not been successful finding a cure, we have been highly successful in driving the industry to consider better tools for better diabetes management and much of that has been from the research that did not bring us a cure!
For more, read Dr. Cogen's response here.
Published On: June 30, 2011