Stem Cell Science Vs. Politics

In Minneapolis right now, there is a rally taking place to try to stop a bill from being passed that would ban stem cell research.   The story can be found in the Minneapolis StarTribune.  The group that is driving this debate is the Minnesota Citizens Concerned for Life.  If this bill would pass, it would not only hinder important research done in Minnesota, but could spread to other research centers as well.

Their argument is under the guise of human cloning, but would cut much deeper.  The stem cell research that is focused on curing diabetes and other diseases is not based on cloning at all.  Much of this research uses adult stem cells which are taken from living humans and sometimes uses cells from the patient's own body.  Embryonic stem cell research uses cells from cell lines that are already created.  The cells are not fertilized with only research as an end result.  They are already present and would eventually be discarded.

Our country is already behind many others because of the strict ban imposed by President Bush.  Many of our citizens are going to other countries for treatment in centers that might not be as accredited or even as safe as our own would be.  This science is destined to evolve with or without the support of groups like this one.  It will be a major milestone in the human condition when we have the capability to cure or suppress terrible diseases with this mechanism. Our country should be a part of this.

It is a shame that a small group of single minded people could have such a devastating effect on research that could save so many lives.  I wonder how many of them really understand the biological and ethical implications of what they are trying to accomplish.

Diabetes Research Summit interviews

The interviews of myself and Dave T. were just posted at the Diabetes and Research and Wellness Foundation site.  I'm hoping that the other interviews will be available soon.  Watching these brings back so many good memories.  It was such an exciting and important event.  I hope that it generated both interest and funding for this research.  I still have the impression that islet cell transplants are not well known or understood even in the diabetic community.  I continue to read blogs written by diabetics and online magazines and social media and see that so many diabetics honestly don't have hope for a cure in their lifetimes.  I add my two cents whenever I can, but still reach only a small percentage of this population.

As for the state of my health, it has been very up and down lately.  Both my general health and my blood sugars.  It is very interesting to see how they directly parallel my symptoms.  I already wrote about the cold that I had in early February.  It lasted about 19 days and required antibiotics.  When this subsided, I had about a week of feeling good.  My BGs and insulin needs went all the way back to normal (8 or 9 units/day).  Then,  I developed some intestinal problems that lasted most of 2 weeks.  My BGs and insulin needs both increased again, although not as much.  I was very concerned that it was due to my immunosuppressants that have needed increases in dose for the last few months.  But, either I have acclimated to that, or I am over something that I was infected with.  Now, I feel fine again.

I have just returned from a very nice trip to California.  My Mom and I went to visit Gary in Santa Barbara and Cassie in San Clemente.  It was so extremely nice to see them and the sun. Of course,  we were there during the tsunami warning.  We were able to avoid the beach that day and I understand that not much happened anyway.

We returned early this morning.  Today, my day will be to puppy proof the house and go pick up a puppy from the Assistance Dog of America Inc.  I have decided to foster a service dog for the first year of its life.  I'm sure that it will be both lots of work and lots of fun.  I will be posting updates of this adventure.

Islet cell transplants can be cost effective as well as increase the quality of life- a study

I recently found this abstract and thought it was very interesting and exciting.  I was able to get a copy of the entire article from a friend, thanks Jason, but can't print all of it due to copyright laws.  I am going to attempt to write about the highlights of what this shows.

A health economic analysis of clinical islet transplantation

Keywords:

• cost;
• cost-effectiveness analysis;
• economic model;
• health economics;
• islet cell transplantation

Beckwith J, Nyman JA, Flanagan B, Schrover R, Schuurman H-J. A health economic analysis of clinical islet transplantation. Clin Transplant 2011 DOI: 10.1111/j.1399-0012.2011.01411.x. © 2011 John Wiley & Sons A/S.

Abstract:  Islet cell transplantation is in clinical development for type 1 diabetes. There are no data on the cost in relationship to its benefits. We performed a cost-effectiveness analysis and made a comparison with standard insulin therapy, using Markov modeling and Monte Carlo simulations. The patient population was adults aged 20 yr suffering from hypoglycemia unawareness. Data were estimates from literature and clinical trials: costs were based on the situation in the United States. For insulin therapy, cumulative cost per patient during a 20-yr follow-up was $663 000, and cumulative effectiveness was 9.3 quality-adjusted life years (QALY), the average cost-effectiveness ratio being $71 000 per QALY. Islet transplantation had a cumulative cost of $519 000, a cumulative effectiveness of 10.9 QALY, and an average cost-effectiveness ratio of $47 800. During the first 10 yr, costs for transplantation were higher, but cumulative effectiveness was higher from the start onwards. In sensitivity analyses, the need for one instead of two transplants during the first year did not affect the conclusions, and islet transplantation remained cost-saving up to an initial cost of the procedure of $240 000. This exploratory evaluation shows that islet cell transplantation is more effective than standard insulin treatment, and becomes cost-saving at about 9–10 yr after transplantation.

This study has attempted to compare the cost of managing Type 1 diabetes by intense insulin therapy to the cost of intervention with an islet cell transplant.  Also woven into the design is how both affect the quality of life.

It begins with data on islet cell graft survival.  I converted their graph into a chart.

one year results:     full function= 93%         partial function= 8%         no function= 0%

five year results:      full function= 47%         partial function= 37%       no function= 17%

ten year results:       full function= 27%        partial function= 49%        no function= 24%  

This shows that most recipients make it to one year, and half make it to five years with no insulin.

And that half make it to ten years with at least partial function.

This is very positive.  Its personally disappointing to me because I am behind the curve.  I only made it 2 years with no insulin, but it gives me hope that I will remain where I am for awhile which is still at a very good place.  This data reflects what I notice from the cast of characters on the islet cell recipient facebook page as well.

The Quality of life variable was very complicated and I am going to simplify it greatly.  It was comparing how the hardships of each treatment affected the quality of the patient's life. The values ranged from 0 which is worst to 1 which is best.  The values that I thought the most interesting were:

A healthy person aged 25-34 had a quality of life valued at 0.91

A diabetic aged 25-34 had a quality of life valued at 0.81    If this person had hypoglycemic unawareness, which all recipients do, a reduction of 0.06 put this pt at a 0.75 quality of life.

From here, adjustments were made base on diabetes causing complications that the insulin group would face, and side effects and graft failure issues that the transplant group would face. A graph shows a mostly parallel line with the transplant group slightly ahead of the insulin group.

Then came the cost analysis.  The numbers themselves were stunning.

Cost of the organ procurement was $25,000.

Cost of harvesting the islets was $20,000.  with a 50% success rate means $40,000.

Cost of immunosuppression was about $1400/month

Cost of transplant was $93,500.  Each successive year was $19,000.

Cost of insulin therapy/year was $6,600.   The cost of having complications varied from $106,000 for renal failure to $1,400 for neuropathy.

Combining these two variables shows that initially the transplant is more costly.  But, over time, as the cost of the transplant stabilizes, the cost of insulin therapy and its long term complications increases.  This study covered a span of 20 years.  At about 9 years, the costs intersect and the islet cell transplant remains the lower cost option.

Interesting numbers here were:   

20 year cost of insulin therapy was $663,000.  Quality of life years gained was 9.1.

20 year cost of islet cell transplant was $519,000.  Quality of life years gained was 10.9  

The article goes into much more detail, but these are the highlights.  It also includes a discussion about how the transplant procedure is expected to improve.  This has already proven to be true in that due to a change in an enzyme used in the harvesting procedure, more islets are now obtained per pancreas than when I had my transplant in 2008.  And there is much more on the horizon............