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Why Federal Stem Cell Policy Must Be Expanded

Posted by jojok on 2005.01.06 at 23:15
full article at http://www.pfaith.org/jdrf-scr.htm

Why Federal Stem Cell Policy Must Be Expanded


A Juvenile Diabetes Research Foundation Scientific White Paper: August, 2004


 



 Executive Summary


JDRF approaches this issue with a single agenda: to find a cure for type 1 diabetes.  Juvenile, or type 1, diabetes afflicts almost two million Americans, many of them children, and strikes tens of thousands more every year at an accelerating rate.


Embryonic stem cell research offers one of the most promising avenues to accomplish JDRF's ultimate goal of a cure.  JDRF had hoped that the August 2001 Federal stem cell policy would be the beginning of intense scientific effort to reach this goal.  But the objective truth echoed by every leading researcher in the field is that the policy, while well intentioned, will not permit research to advance at the pace it can and must; in fact, the policy is actu­ally slowing the scientific progress in Federally funded research that the President himself championed.


As much as anything, the call for an expansion of Federal stem cell policy reflects what scientists have learned since the August 2001 announcement.  Our understanding of the science has progressed since then, and knowledge of the NIH -approved stem cell lines has grown much deeper.  It is time to adjust the Federal policy so that it accurately represents the latest understanding of the science.  The simple, inescapable fact - acknowl­edged by the Federal government itself - is that access to additional stem cell lines will accelerate the potential breakthroughs required to cure not only diabetes, but a range of diseases afflicting millions of Americans.


The problems with the existing policy are numerous and pervasive. They include:


1) Of the original 78 stem cell derivations that were declared eligible for US Federal funding under the August     2001 policy, only 21 are actually available for distribution and study;


2) Because the NIH-approved stem cell lines were developed using science that has since seen significant  improvements and progress, they may prove to be far more limited in their biomedical research utility than lines  created more recently;


3) The NIH lines lack the genetic diversity scientists need to do research that could create therapeutic treatments for millions of Americans;


4) Because human embryonic stem cells are heterogeneous, with some showing a greater propensity to become certain types of cells, a limited number of stem cell lines can decrease the breadth of research opportunities for scientists;


5) The absence of disease-specific stem cell lines eligible for Federal funding means that the current policy is lim­iting stem cell research from beginning on dozens of genetic diseases such as Duchenne muscular dystrophy and Huntington's Disease, potentially adding years to the discovery of treatments for millions of Americans;


6) All the NIH-approved lines were isolated in contact with mouse 'feeder' cells.  As a result, the FDA must con­sider any therapies developed using these stem cells as xenotransplants, creating a huge hurdle that discour­ages the biotech and pharmaceutical industries from developing treatments utilizing those lines; and


7) Policy limits on stem cell research discourage scientists from entering the field.


Following is a more detailed discussion of each issue.


 

Comments:


singnyc
singnyc at 2005-01-25 16:47 (UTC) (Link)
Hi!


Please take a moment to visit this site: http://www.petitiononline.com/type1/petition.html

Its a petition I composed to help find a cure for diabetes and to support funding for stem cell research!

Please, read it and sign it! Please pass this along to anybody and everybody!! Post it on your LJ, if you want!

Being a Type 1 diabetic this is an issue that is very close to my heart, and is something I am very passionate about.

Thank you!
waycurious at 2005-08-22 15:53 (UTC) (Link)

ESCs can't treat Type 1 Diabetes

Diabetes: ESCs don't make beta-producing cells - but they did form tumors. http://www.freep.com/news/health/spine13_20040413.htm. Adult cells do make beta-cells . http://www.medicalnewstoday.com/medicalnews.php?newsid=18601 , http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15564314 ,http://www.nih.gov/news/pr/nov2004/niddk-25.htm

Bone Marrow used to make insulin http://www.hematology.org/news/press/press_120903_5.cfm?pagemode=print

Mice have been cured of diabetes within 40 days with just a shot. http://www.healthcentral.com/news/NewsFullText.cfm?id=511308

And in humans … "But of the 250 patients who have received the newest version of the transplant, more than 80 percent have been free from insulin shots or insulin pumps for more than a year." http://www.ajc.com/health/content/health/special/0603/01exdiabetic_sidebar.html
waycurious at 2005-08-22 16:06 (UTC) (Link)

More on Type 1

Juvenile Diabetes: Massachusetts General Hospital researchers have harnessed newly discovered cells from an unexpected source, the spleen, to cure juvenile diabetes in mice, a surprising breakthrough that could soon be tested in local patients and open a new chapter in diabetes research. http://www.boston.com/news/nation/articles/2003/11/14/juvenile_diabetes_cured_in_lab_mice/a treatment that cures advanced type 1 diabetes in mice was discovered. http://www.eurekalert.org/pub_releases/2003-11/sfwh-ros111403.phphttp://www.eurekalert.org/pub_releases/2003-11/sfwh-ros111403.php
Scientists at the University of Florida say they've cultured adult bone marrow stem cells to become insulin producing cells. In tests those cells normalized blood glucose levels in diabetic laboratory animals. http://www.wistv.com/Global/story.asp?S=1734712

Knowing that EmbryonicSCs can't be just 'injected' (like AdultSCs can) - how invasive and dangerous do you think the ESC treatment would be? ASCs are superior especially in diabetes. (Most serious researchers abandoned ESCs for curing it years ago!)
waycurious at 2005-08-22 16:42 (UTC) (Link)

Correction

Here's the right link to:

Insulin expressing cells from differentiated embryonic stem cells are not beta cells.
Sipione S, Eshpeter A, Lyon JG, Korbutt GS, Bleackley RC (2004). Diabetologia Feb 14

(They found that instead of producing insulin, they were acquiring it from the growing medium - oh, and forming tumors.)

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=14968299&dopt=Abstract

Also:

Teratoma Formation Leads to Failure of Treatment for Type I Diabetes Using Embryonic...
Fujikawa et al. Am J Pathol.2005; 166: 1781-1791.



You CAN get insulin from white blood cells: http://www.stemcellnews.com/articles/stem-cells-diabetes.htm

British doctors announced they had cured a 61-year-old
man who had suffered from the most extreme form of diabetes for over
30 years by injecting pancreatic cells into his liver.
http://story.news.yahoo.com/news?
tmpl=story&cid=1507&ncid=1507&e=3&u=/afp/20050309/hl_afp/healthdisease
diabetesbritain_050309143703

Success in Converting Adult Stem Cells into Insulin-Producing Cells Triggers Agreement Expansion http://www.medicalnewstoday.com/medicalnews.php?newsid=18601

Epithelial-to-Mesenchymal Transition Generates Proliferative Human Islet Precursor Cells
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15564314


You know, you're diverting research from what IS working to what CAN'T!
waycurious at 2005-08-22 16:03 (UTC) (Link)

Funding is adequate

Remember, the only type of funding that is effected by the current policy is with HUMAN embryonic stem cells. ESC research w/Animal models is funded normal.

This makes perfect sense since there just aren't tons of embryos waiting to be used for research (see below). To get more, we have to exploit poor women for their eggs. Altruistic egg donation is banned in many progressive countries like Denmark & Israel (Canada since the 1980s!) It's just plain dangerous http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12735857&dopt=Abstract

Now, how fast do you think scientists could go through those eggs? (Read July 2005 Sci Am for more info) Heart patients alone = the number of eligible donors!

U.S. Policy on Funding

NIH stem cell funding for 2003 totaled over $215 million and "unlike many countries, there are no limits in the United States on private stem cell research". http://www.hhs.gov/news/press/2004pres/20040808.html

Funding for ESC research increased 132 % from FY 2002; in FY 2003 http://www.hhs.gov/news/press/2004pres/20040714b.html ESC Research Enhancement Award http://grants2.nih.gov/grants/guide/pa-files/PAR-03-177.html They are training researchers http://stemcells.nih.gov/research/training/schwartz.asp

FromPeduzzi-Nelson, Ph.D. "Research is not being slowed by the current ban on Federal funding of human embryonic/fetal stem cells. Every clinical trial, new drug, new treatment is based on animal studies. There is no ban on animal embryonic or fetal stem cells or animal cloned cells. There is only a ban on Federal funding of human embryonic stem cells from the destruction of new embryos." In fact, France, where cloning is banned, scientists were going to come to the US where it is both allowed and funded http://science.bio.org/cloning.news.html

-----

Of the 400,000 frozen embryos often cited, only about 11,000 would be available for research (according to the RAND study from where the 400,000 number comes). The others are either to be used for 'family building' or must be discarded. This may produce 275 additional lines. http://www.rand.org/news/press.03/05.08.html And, that could be an overestimate. Of the 200 frozen embroys available for research at the Jones Institute for Reproductive Med in Virgina, Dr. William Gibbons there stated, "there is no guarantee we would get any stem cells". Furthermore, Stanford's Dr. Behr says, "By far, by far, the vast majority of embryos that are frozen are not good. If we thawed 10,000 embryos, we would get 100 or so that are viable blastocysts." (See also: SCIENCE MAG, "Issues in Oocyte Donation for Stem Cell Research", Vol 308 p. 1747-1748 (17 June 2005).



waycurious at 2005-08-22 16:08 (UTC) (Link)

Re: Funding is adequate

Oh yeah...

When the policy was made in 2001, only ONE researcher had applied for hESC funding ... and it was APPROVED! To the best of my knowledge, applications have yet to exceed the amount NIH is giving. (That's why they are training people.)

This is a red-herring issue.
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