Dr. Faustman and the BCG Trial

Have you heard about Dr. Faustman? I have been following her work for about a year now. She is testing whether BCG (Bacillus Calmetta-Guerin) can be used to cure type 1 diabetes.

You know, I don’t normally get too excited when I hear the word “cure.” We’ve been hearing it for decades, and here we are, still testing and bolusing, and treating lows and highs. But this study looks different.

BCG is a generic drug with an impressive safety profile. It is currently used as a tuberculosis vaccine and to treat cancer. Dr. Faustman’s lab believes that, at higher or more frequent doses, the drug can actually target and kill the rogue T cells that destroy our beta cells.

In 2003, Dr. Faustman was the first person to actually cure diabetes in naturally diabetic mice. When the mice received BCG, the defective T cells were killed, while the healthy T cells remained. Perhaps even more amazing, the mice actually began to generate new beta cells and, as a result, the insulin they needed to survive.

The study went on to test and confirm that splenic stem cells could be used to create new beta cells in case the pancreas was not able to do so.

Of course, we know that mice and humans are two, very different … well … animals, and if we got our hopes up every time a scientist cured diabetes in mice we would spend a lot of time disappointed. What makes this study different, though, is that the mice had natural diabetes (not diabetes artificially caused in the lab,) the mice had reached old age with the disease and, perhaps most importantly, the study has been repeated and verified six different times.

Despite this success, Dr. Faustman has met with skepticism and even opposition in the field. Most striking is the JDRF’s refusal to provide monetary support, even though three labs that were funded by the JDRF confirmed Dr. Faustman’s findings. This opposition limited Dr. Faustman’s ability to raise funds to move forward with human trials for quite some time, but then the Iacocca  Family Foundation stepped up and provided a hefty donation so that the Phase I human trials could begin.

The Iacocca Family Foundation was established by Lee Iacocca in honor of his wife who died of complications of type 1 diabetes.

The latest news from the Faustman Lab is that Phase I of the human trials is complete and it was a success. Phase I was a safety trial in which the team demonstrated the safety of the treatment. The trial was a double-blinded placebo, controlled trial and the team found no severe reactions to the vaccine other than the expected inflammation at the injection site. The safety reports are now filed with the FDA and the Massachusetts General Hospital data safety monitoring boards.

Dr. Faustman is now working to raise funds for Phase II, in which the team will identify the best dose and the best timing of administration of BCG. The study can begin as soon as they have the necessary funding.

The team expects the trials to take about another eight years, and three more phases. According to the Faustman Lab website, the team is still enrolling participants and is actively seeking and accepting donations to bridge the funding gap for Phase II. You can learn more or make a donation at http://www.faustmanlab.org/index.html

Resources

• The Faustman Lab Website, http://www.faustmanlab.org/index.html
• Dr. Faustman on Diabetes Cure Trial on Diabetes Daily, http://www.diabetesdaily.com/edelman/2008/09/diabetes-cure.php
• Update on Dr. Faustman’s Research on Reversing Type 1 Diabetes on Diabetes In Control, http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=8385:update-on-dr-faustmans-research-on-reversing-type-1-diabetes&catid=53:diabetes-news&Itemid=8&Itemid=8
• The Iacocca Family Foundation Website, http://www.iacoccafoundation.org/index.html
• Determination of Dosing and Frequency of BCG Administration to Alter T-Lymphocyte Profiles in Type I Diabetics on the FDA’s Website for Clinical Trials, http://clinicaltrials.gov/ct2/show/NCT00607230?term=BCG&cond=Diabetes&rank=1

This Just In: Pass the Veggies

There has been quite a bit of buzz online lately about a study conducted in Sweden that indicates that expectant mothers who ate more vegetables were less likely to have children diagnosed with Type 1 Diabetes:

• Veggies in Pregnancy Lowers Child’s Diabetes Risk
• Pregnant Mothers: Eat Greens to Lower Child’s Diabetes Risk
• Intake of vegetables during pregnancy may prevent diabetes in unborn child
• Veggies in Pregnancy Lowers Child’s Diabetes Risk

In particular, women who ate vegetables every day during their pregnancy were less likely to have children diagnosed with Type 1 Diabetes by the age of five than women who did not eat vegetables everyday. The study tested 6,000 five-year-olds, three percent of which either already had been diagnosed with Type 1 Diabetes or already had the antibodies in their blood that indicate an elevated risk of developing the disease. The  risk was twice as  high in children whose mothers who rarely ate vegetables during pregnancy. Meanwhile, children whose mothers ate vegetables every day during pregnancy had the lowest risk of developing the disease.

I have to admit, this idea seems like a  longshot … especially given the genetic predisposition for my child in particular. I was diagnosed at the age of four and my mother was diagnosed at the age of 12. But maybe the veggies help ward off the “environmental trigger” that pushes our bodies over the edge. At the very least, the veggies should help me keep my weight gain down and my blood sugars in range which should help prevent complications. And besides, every little bit helps, right? I will be pushing the leafy greens during this pregnancy just in case!