CIRM Employs Negative Reviewers of No Scientific Integrity to Make Dishonest Comments and Scores to Block Prop71 Stem Cell Research for Funding and Cover Up COI

To understand why billions of Prop71 have flowed into conflicts of interest (COI) but not stem cell research from CIRM unobscurely, it may help to look into CIRM flawed review process, particularly the part that has been forbidden by CIRM internal COI to disclose to the public, covered up as CIRM pre-application or LOI. It is interesting to see CIRM president Alan Trounson’ very public demand for his $70 million alpha clinic proposal while, unseen by the public, he is so evidently negligent or even negative about stem cell research and therapy in handling CIRM flawed grant review process as CIRM president. The only problem is that, so far, CIRM has not had one FDA-approved stem cell therapy, not even any CIRM sponsored IND or clinical trials. Without clinically-suitable human stem cells or FDA-approved stem cell therapy, Alan Trounson’s alpha clinics would be no different from those stem cell con man’s clinics hunted by FBI. It would turn out to be just another way for Alan Trounson to get $70 million freebies for CIRM COI, while under the cover he has been deliberately blocking those real beneficial proposals that would provide stem cell therapy for his alpha clinics using CIRM COI flawed review process with his apparent consent.

If ICOC’s COI is only speculation in public, COI in CIRM grant review is monopoly, even to the extent of extortion. Therefore, it is no surprise CIRM has been very resistant to be transparent in its grant review. So far, it seems that CIRM reviewers have been only capable of making negative comments that are so full of false statement, factual error, bias or predisposition, COI that have comprised the integrity and credibility of any advices provided by the reviewers. It is quite shocking that CIRM reviewers of no scientific integrity usually could not note any strength of hESC research proposal and intentionally gave false or biased or dishonest comments and scores against scientific evidences that did not reflect the overall impact and scientific merit of hESC grant applications (see hESC grant title and summary below for example). Our proposal shown below is to understand molecular mechanism in human embryonic stem cell neuronal differentiation using novel lineage-specific differentiation technique in hESC research breakthrough. Such technique has never been described before us. Only RA effect on hESC differentiating multi-lineage embryoid body has been described before, but the effects are small, and molecular mechanism in human and mouse ESC is totally different. There is nothing in our proposal about iPS cells and some other irrelevant comments made by CIRM reviewers. We have written to CIRM president/vice president, CIRM, ICOC multiple times about such flawed reviews from CIRM reviewers before, however, it seems that CIRM president/vice president or chair or ICOC have never been able to address such serious issues as CIRM reviewers’ COI or scientific misconduct, deliberately brushed it off, never responded to our complaints about CIRM flawed reviews or COI in CIRM review, and covered it up by consent to reviewers’ COI or false statement or flawed review. Considering many of CIRM ICOC members are leaders, physicians, Deans, and Presidents who know more than anyone else how serious a issue of scientific misconduct is in their own institutions, particularly provided by CIRM review comments for unmistakenable evidences, it would be detrimental for us to think that CIRM or ICOC or CIRM president/vice president or chair have been actually behind CIRM reviewers’ COI, false statement, or scientific misconduct by deliberately avoiding to address CIRM flawed grant review process.

RFA 13-02, RB5-07199:

Molecular Controls in Human Embryonic Stem Cell (hESC) Neuronal Lineage Specification

The hESCs provide a powerful in vitro model system to investigate molecular controls in human embryonic neurogenesis as well as an unlimited source to generate the diversity of human neuronal cell types for CNS repair. However, realizing the potential of hESC derivatives has been hindered by conventional approaches for generating neuronal cells from pluripotent cells through uncontrollable, incomplete, and inefficient multi-lineage differentiation. We found that pluripotent hESCs maintained under the defined culture conditions can be uniformly converted into a specific neuronal or cardiac lineage by small molecule induction. This technology breakthrough enables well-controlled efficient neuronal lineage-specific differentiation direct from the pluripotent state of hESCs. In this project, this novel hESC model of neuronal lineage-specific progression will be characterized and used for genome-wide genetic and epigenetic profiling to generate a comprehensive knowledge of developmental regulators and networks for identification of molecular controls in hESC neuronal lineage specification. Fulfilling the goal of this project will be provide a comprehensive understanding of molecular neurogenesis in human embryonic development, thereby, reveal potential molecular and cellular therapeutic targets for the prevention and treatment of CNS disorders. The outcome of this project will have a transformative impact on a broad area of biomedical sciences and public health.  

From: Gil Sambrano [mailto:GSambrano@cirm.ca.gov]
Sent: Friday, May 24, 2013 12:58 PM
To: parsons@sdrmi.org
Subject: CIRM Basic Biology V Awards

Dear Dr. Parsons:

Thank you for submitting your proposal under the CIRM RFA 13-02: Basic Biology V Awards. After careful consideration, your PreApp was not selected for further review under this RFA.

The goal of the PreApp process is to identify proposals that are the most responsive to the RFA objectives and likely to be competitive. For this competition we received over 340 PreApps and selected about 60 for a full application. The process was designed to handle a large volume of proposals and to ensure a rapid turn-around on the review. Reviewers may provide brief comments that highlight strengths and weaknesses where appropriate. The comments are not comprehensive and do not necessarily provide all the reasons for an invitation or denial. Each application is assigned to 3 independent reviewers and each reviewer assesses approximately 20-30 PreApps within their area of expertise and scores the applications on a scale of 1 to 100, 100 being the most meritorious. CIRM scientific staff further assesses proposals to ensure that projects meet eligibility requirements and are responsive to the RFA. CIRM invites the most highly ranked and responsive PreApps as determined by the external scientific reviewers and CIRM science officers.

The summary below shows the final score for your PreApp and comments provided by reviewers.

We thank you for your interest, and we encourage you to respond to future CIRM initiatives. We look forward to your future applications to CIRM. If you have any questions about the review please feel free to contact me.

Sincerely,

Gil Sambrano

Gilberto R. Sambrano, Ph.D.
Associate Director, Review
California Institute for Regenerative Medicine
210 King Street
San Francisco, CA 94107
Phone: 415-396-9103
gsambrano@cirm.ca.gov

SUMMARY OF REVIEW

Overall Scientific Score: 33.33

Comments provided by reviewers:

Comments 1:

Strengths:

            The use of an in-vivo assay in Milestone 3 is very significant as it validates the in-vitro results of all the other Milestones.

Weaknesses:

            The direct conversion of hESCs to neuronal derivatives has already been extensively described by many different laboratories. (our response: the reviewer’s statement is false & against scientific evidences. The fact is the direct conversion of hESCs from the pluripotent state to neuronal derivatives has never been done by any laboratories before us.)

            It has been shown that inhibition of the TGFB pathway by SB and LDN small compound is sufficient to robustly induce conversion to telencephalic. (our response: The reviewer did not provide the fact that it was induced from neuroepithelial cells isolated from embryoid bodies (EBs) in extremely low efficiency by University of Connecticut & groups connected to CIRM vice president/UC connect/Sanford/UC. Our study overcomes their shortcoming to generate neurons direct from hESCs in high efficiency and purity, not isolated from EB.  The fact the reviewer did not disclose shows that this review had conflicts of interest (COI) and intentionally gave false or biased or dishonest comments against scientific evidences, which has affected the integrity of advice provided by this reviewer).

            The use of RA is sub-optimum as it as it generates random sets of neurons, which will make collective data analysis useless. (Our response: the reviewer’s statement is false & against scientific evidences. RA is optimized to induce neuroectoderm and neuronal differentiation from hESCs to a large supply of neuronal cell type and subtypes, which is critical for collecting data for analysis of molecular mechanism in hESC neuronal lineage specification.)

Comments 2: (our response: our proposal is to investigate molecular mechanism in hESC neuronal lineage-specific differentiation and has nothing to do with iPS cells and the negative comments of this reviewer (see title & summary). The reviewers’ comments are false, which show COI since this review could not note any strength of this hESC proposal and intentionally gave false or biased or dishonest comments against scientific evidences, and which has affected the integrity of advice provided by this reviewer).

Weaknesses:

- This protocol for differentiating human iPSCs into neurons has not particular advantages respect to others already present in the literature, while having some substantial drawbacks:

1) this protocol is not designed to generate one particular neuronal subtype while generating a variety of very different neurons. It is not clear which relation is existing between DA and spinal cord neurons which are both generated by this same protocol.

2) it is not explained which particular type of DA or spinal cord neurons are generated with this protocol. Are DA neurons patterned as ventral mesencephalic Pitx3+ neurons? This is a crucial information for generating therapeutic relevant neurons.

3) Retinoic Acid (RA) it is a well-known inducer of caudal neuronal subtypes. It is therefore unclear how DA neurons can be specified in this particular regimen

4) Preliminary data are missing showing electrophysiological maturation and activity of iPSC-derived neurons

Considering these pitfalls, caution is required in employing this protocol in large extent and a better characterization of the differentiated neurons is necessary to validate the system.

Comments 3: (our response: our proposal is to investigate molecular mechanism in hESC neuronal lineage-specific differentiation using a novel technology by small signal molecule induction. The reviewer’s comments are vague, did not give any specifics. It is commonly known that miRNAs are governors of regulatory circuits. The reviewers’ comments are biased, which show COI since this review could not note any strength and apparent novelty of this hESC proposal and intentionally gave false or biased or dishonest comments against scientific evidences, and which has affected the integrity of advice provided by this reviewer).

novelty of this application not at all clear

many vague, sweeping statements about the transformative nature of the work, but very little focus

not at all clear how regulatory circuits will emerge from miRNA profiling

CIRM Comments:

NA

Gilberto R. Sambrano, Ph.D.

Associate Director, Review

California Institute for Regenerative Medicine

210 King Street

San Francisco, CA 94107

(415) 396-9103

CIRM Mediocre Leaders of No Leads --- Directors’ Sidekicks and Freebies

CIRM awarded leaders all bore one unmistakenable resemblance to the sidekicks of CIRM directors, such as Eric Ahrens and Robert Wechsler-Reya to Sanford Directors Larry Goldstein and Evan Snyder, Hiromitsu Nakauchi to Irv Weissman of Stanford U, Barry Stripp to Cleve Svendsen of Cedars-Sinai & UCLA, Kevin Parker to Deepak Srivastava of Gladstone & UCSF. Are any leaders in any societies, coalitions, or communities expected to have at least some sort of acceptable leadership activity or accomplishment to be a leader, if it is not up to the standard of outstanding?  However, CIRM awarded leaders are definitely exception to the meaning of leader in any languages. Besides their close relationship with CIRM directors, they all have one thing in common, they have absolutely no leadership activity nor accomplishment in the stem cell community to make them pass the standard of acceptable or outstanding to lead anyone but corruption. Therefore, it would be more appropriate to translate CIRM leaders as CIRM directors’ sidekicks or freebies for sneaking tens of millions of taxpayer money from stem cell research in CIRM’s own language that can only be found in the government corruption directory. To make it more obvious, CIRM ICOC directors and president Alan Trounson even went extra miles to sneak more millions of taxpayer money for stem cell research as freebies to CIRM vice chair/UC connect Duane Roth’s company Sangamo BioSciences for something that is neither new nor eligible for Prop 71 stem cell research. It makes us all wonder what those CIRM ICOC directors are wasting taxpayer money to meet together really for on a regular basis, how come CIRM directors’ requests for sidekicks and freebies have become commands to CIRM ICOC for hundreds of millions of taxpayer money, and how come CIRM directors’ interests and requests, and ONLY CIRM directors’ interests and requests, for sidekicks and freebies are CIRM president, chair, ICOC’s commands for money in a State government agency that is designated public money for stem cell research and fair competition by a law. 

Skating on Thin Ice --- The Bottled-Up Stem Cell Community Deceived by Dictating Interest and High Impact of Unquestionable Prestige

Today, with the world second largest economy and a new generation emerging from the 90^th, China’s culture revolution has been left behind in a bottled-up history. No one, not even those who were born into it, could make sense of culture revolution any more, could make sense of the insanity, brutality, and mass destruction committed by those who were so young so innocent. Only those who once lived in the bottle and had their life dictated by the unquestionable will and sugar-coated political interest of a single high power beyond their control could believe what had really happened was totally unavoidable. For the rest, reading culture revolution is like reading the consequence of irrationality. In my teenage years, not even through my aunt’s hilarious imitation, I could make sense that my young, handsome, intelligent, and kind parents, uncles and aunts, would leave their infant kids alone at home in the dark, voluntarily go to do their totally ridiculous duty dancing on the streets just to show their devotion to a dying old man. Until they finally got their own common sense back, just in time to catch the last nearby train flee out of the exploded conflict zone, leaving their toddlers behind to survive a war-torn city.

The recent wave of induced pluripotent stem cells (iPS cells) in the stem cell community is just as insane as the culture revolution, making no sense at all to anyone who has little bit of common sense, to anyone who has little bit of scientific integrity. Besides the Nobel committee’s golden framed words that need Karolinska Institute’s intelligence to understand, besides the perplexed news persons’ copied words that do not need Karolinska Institute’s intelligence to tell that it sounded very much like a scam, what has Yamanaka really accomplished? Yamanaka put not just one, not two, not three, but 4 oncogenes into skin cells, not even the skin of humans but lab rats, rationally or scientifically, he would not get anything coming out of it but cancer cells. If Yamanaka told the public in lay language what he really did, probably any ordinarily people would only think he was just some mad scientist. However, it was told through the high impact peer-reviewed prestigious scientific journal Cell, it was told in sugar-coated political interest by highly-trusted big names as the “safe” and “ethical” alternate for human embryonic stem cells (hESCs), it was copied by every major news agencies throughout the world as “the biggest breakthrough of stem cell research” without hearing a single critique or even precaution, like a man-made earthquake with the magnitude that could even shake the more than 100 years of unquestionable prestige of Nobel Assembly. Although Yamanaka’s Bernie Madoff scam in the stem cell community does not make any sense scientifically, it does make sense monetarily if simply check how much taxpayer money has gone into the epicenter of Yamanaka iPS cells from NIH and CIRM since.   

In 1989, James was in London, stayed in Margaret Thatcher’s old flat. He visited Berlin Wall without any speculation that someday it would come down. He had to memorize his passport number in case that the Berlin Wall might really prevent him from coming back to the free world. Then, a few months later, it was gone, forever. Danny was in Beijing, turned on the TV in his hotel room and saw CNN to his surprise. He thought Chinese people could actually watch CNN, how wonderful. I was in the same city, and like all the Chinese people only 100 feet away from his Westerner-only hotel, did not even know the existence of CNN and could only watch one single state-controlled news broadcast – China Central News. Nearly 20 years later, when I sit in front of my parents’ TV bigger than the one we had, that was still all I could watch. If talking enforced high impact, the Central News broadcast occupies the prime time, copying the same exact words with never-changed sugar-coated tone through every channel, every household, every neighborhood, and every dinner table of an entire country that I have never missed even a bit. A KFC and a large shopping mall erupted right next to my old elementary school that was still very much unchanged. I went into KFC to taste the chicken that looked and tasted just like a KFC, then went into the shopping mall to spend my parents’ money and brought a few pairs of pure gold earrings, then went by my old elementary school that looked just like what I remembered, having this incredible feeling that I was going through a time machine. Hong Kong, from where I flew in, was only 2 hours away. Their TV satellites could pick up the signals of some Hong Kong channels. However, the interfering signals to those channels were so bad, few minutes staying on those snowy channels would only make the Central News sound unbelievably wonderful. 

Although Berlin Wall had come down, without transparency, the peer-review system can be easily broken by the dictating interest and high impact of unquestionable prestige, and Berlin Wall can always be rebuilt by a privileged few to implement their own will and fence away fair competition and everything else that a democratic free country has stood for.

This piece is written in memory of Margaret Thatcher, the only woman and only scientist who had become a great politician of the world and had sailed through a stormy era in our time. 

NIH Response to Letter to NIH Director Francis Collins

Dear Dr. Gadbois,

Thank you for your response on behalf of Dr. Francis Collins. Although we do not have NIH actual award# for human embryonic stem cell (hESC) research, according to NIH online statistics at http://stemcells.nih.gov/research/funding/pages/Funding.aspx, in 2012, only 10% of total NIH fund to stem cell research (~ $1.468 billion) was gone into hESC research, while 56% (~ $822 million) was gone into non-human stem cells. The significance and benefit of hESC research should be in reverse with the fund supported by NIH. In the 10%, hESC research is often only a tiny fraction or small project of adult induced pluripotent stem (iPS) cell U grants or large center grant awards, so the actual NIH fund to hESC research is even much less than the 10%.

My hESC grant applications have encountered such non-peer reviewed processes or events in NIH CSR (Center for Scientific Review) peer review as that study section overridden the reviewers’ scores to outside of funding range or biased reviewers scored to as low as exclusive 9s or 8s (in a scale of 1 to 10 with 1 the strongest and 10 the weakest) for the scientific merits and overall impact of hESC research with significance and impact to understanding human embryonic development and finding a cure for PD, neurological and heart diseases as currently the most promised therapeutic approach closet to provide a cure. I have gone through NIH appeal system for at least 3 times (please see the appealed project title and summary below), the appeals were either not brought up for consideration, or concurred by NIH appeal system to reviewers’ biased recommendation. Therefore, it seems NIH appeal system did not work, at least for my hESC applications. Please do not hesitate to contact me should you have any questions, thanks,

R01 HD073109-01A, Parsons, Xuejun H.

Title: Preclinical study of a novel neuronal progenitor induced from human embryonic stem cells in spinal muscular atrophy model, in response to NIH funding opportunity Program Announcement (PAR) Number: PAR-11-038 Title: Preclinical Research on Model Organisms to Predict Treatment Outcomes for Disorders Associated with Intellectual and Developmental Disabilities (R01).

Project summary: Spinal muscular atrophy (SMA) is a devastating, untreatable, and one of the most common genetic neurodevelopmental diseases leading to infant mortality. Human stem cell transplantation represents a promising therapeutic approach closest to provide a cure to restore the lost nerve tissue and function for SMA. However, to date, lacking of a clinically-suitable source of engraftable human stem/progenitor cells with adequate neurogenic potential has been the major setback in developing effective cell-based therapies. In spite of proffering cures, realizing the developmental and therapeutic potential of pluripotent human embryonic stem cells (hESCs) has been hindered by the inefficiency and instability of generating desired cell types from pluripotent cells through multi-lineage differentiation. To achieve uniformly conversion of pluripotent hESCs to a neuronal lineage, I have established a small molecule induction approach to generate a large supply of novel nurr1-positive human neuronal progenitors direct from the pluripotent state of hESCs (hESC-I hNuPs) in high efficiency, purity, and neuronal lineage specificity to support preclinical research. SMA, characterized by selective degeneration of spinal cord motor neurons, provides an ideal model for in vivo motor neuron dysfunction bioassay. In this project, hESC-I hNuPs will be transplanted into animal models of SMA to determine if the engrafted cells will extend life-span and improve the motor function by differentiation into motor neurons for nerve regeneration and reinnervation of host muscle to provide preclinical evidences of efficacy and safety against incurable motor neuron disease. Their therapeutic behavior, including engraftment/cell survival/integration, migration, differentiation into motor neurons, graft-dependent nerve regeneration and reinnervation of host muscle, and motor function recovery will be assessed for evidences of efficacy, and a lack of tumors and inappropriate cell type formation will be assessed for evidences of safety. Assessment of the potential of hESC-I hNuPs in disease models of SMA will offer critical insights into novel therapeutic strategies against incurable motor neuron disease as well as provide necessary and sufficient preclinical evidences of safety and efficacy to demonstrate their potential as stem cell therapy to be translated to SMA patients for motor neuron repair in clinical trials. The outcome of this proposal will have significant impact on the advance of medicine to provide treatment options for incurable motor neuron diseases in pediatric patient populations.

1 R43 TR000349-01      Parsons, Xuejun H

Title: Dopaminergic specification of human embryonic stem cells for cell-based therapy against Parkinson’s disease (Phase I), in response to NIH funding opportunity Program Announcement (PA) Number: PA-10-122 Title: SHIFT Award: Small Businesses Helping Investigators to Fuel the Translation of Scientific Discoveries [SBIR: R43/R44].

Project summary: To date, lacking of a large supply of clinical-grade human stem/progenitor cells with adequate neurogenic potential has been the major setback in developing effective cell-based therapies for restoring the damaged CNS. Pluripotent human embryonic stem cells (hESCs) proffer cures for a wide range of neurological disorders by supplying the diversity of human neuronal cell types in the developing CNS for repair. However, realizing the therapeutic potential of hESCs has been hindered by the current state of the art for generating neuronal cells from pluripotent cells through multi-lineage differentiation, which is uncontrollable, inefficient, instable, highly variable, difficult to reproduce and scale-up. We found that pluripotent hESCs maintained under the defined culture conditions can be uniformly converted into a specific lineage by small molecule induction. The goal of this project is to use a novel small molecule induction approach for well-controlled efficiently directing neuronal lineage-specific differentiation of hESCs from the pluripotent stage towards human neuronal progenitors and neurons at scale, purity, and DA regenerative potential suitable for preclinical development of cell-based therapy against Parkinson’s disease (PD), a prototypical age-related neurodegenerative disorder. Retinoic acid (RA) was found to induce the specification of neuroectoderm direct from the pluripotent state of hESCs and trigger progression to neuronal progenitors and neurons efficiently by promoting nuclear translocation of Nurr1. In the phase I of this project, the cascade of hESC neuronal lineage-specific differentiation by small molecule induction will be characterized. These characterizations will be used to optimize the hESC neuronal differentiation protocol and to define their homogeneity and dopaminergic (DA) potential. These studies in Phase I will be used to establish the feasibility of this approach prior to initiating Phase II for large-scale molecular profiling to define stage-specific human embryonic neurogenic factors and for preclinical studies of their therapeutic effect in vivo in the DA dysfunction models. These studies will lead to producing a large supply of well-characterized human neuronal progenitors and neurons in high purity and adequate DA regenerative potential for therapeutic applications. Further assessment of their potential in the PD models will offer critical insights into novel neuron replacement therapy as well as provide necessary and sufficient preclinical evidences of safety and efficacy for predicting stem cell therapy outcomes in clinical trials against PD. The outcome of this proposal will have significant impact on the advance of medicine to provide novel graft-dependent stem cell therapy for restoring the lost tissue and function in CNS disorders.

1 R43 HL114131-01A1      Parsons, Xuejun H

Title: Cardiomyocyte specification of human embryonic stem cells (hESCs) for cell-based therapy for myocardium regeneration (Phase I), in response to NIH funding opportunity Program Announcement (PA) Number: PA-09-249 Title: Directed Stem Cell Differentiation for Cell-Based Therapies for Heart, Lung, and Blood Diseases (SBIR),

Project summary: To date, lacking of a suitable human cardiomyocyte source with adequate myocardium regenerative potential has been the major setback in regenerating the damaged human heart. Pluripotent human embryonic stem cells (hESCs) proffer unique revenue to generate a large supply of cardiac lineage-committed cells as human myocardial grafts for cell-based therapy. Due to the prevalence of heart disease worldwide and acute shortage of donor organs or adequate human myocardial grafts, there is intense interest in developing hESC-based therapy for heart disease and failure. However, realizing the therapeutic potential of hESCs has been hindered by the current state of the art for generating cardiomyocytes from pluripotent cells through multi-lineage differentiation, which is uncontrollable, inefficient, instable, highly variable, difficult to reproduce and scale-up. We found that pluripotent hESCs maintained under the defined culture conditions can be uniformly converted into a specific lineage by small molecule induction. The goal of this project is to use a novel small molecule induction approach for well-controlled efficiently directing cardiac lineage-specific differentiation of pluripotent hESCs towards human cardiac precursors and cardiomyocytes at scale, purity, and myocardium regenerative potential adequate for preclinical development of cell-based therapy for heart disease. Nicotinamide was found to induce the specification of cardiomesoderm direct from the pluripotent state of hESCs and trigger progression to cardiac precursors and cardiomyocytes efficiently. The cascade of hESC cardiac lineage specific differentiation by small molecule induction will be characterized. These characterizations will be used to identify cardiac stage-specific markers and optimize hESC cardiac lineage-specific differentiation by small molecule induction to beating cardiomyocytes. These studies in Phase I will be used to establish the feasibility of this approach prior to initiating Phase II for large-scale molecular profiling and for preclinical studies of their therapeutic effect in myocardium regeneration in vivo. These studies will lead to producing a large supply of well-characterized human cardiac precursors and cardiomyocytes in high purity and adequate myocardium regenerative potential for commercial and therapeutic applications. This project is crucial to driving the advance of medicine to provide optimal treatment options for the damaged or diseased hearts that have been lacking. The outcome of this project will have a transformative impact on a broad area of biomedical sciences and public health.

From: Gadbois, Ellen (NIH/OD) [E] [mailto:gadboisel@od.nih.gov]
Sent: Wednesday, May 01, 2013 8:27 AM
To: 'parsons@SDRMI.org'; 'parsons@xcelthera.com'
Cc: HESCREGISTRY (NIH/OD)
Subject: your email to Dr. Francis Collins

Dear Dr. Parsons,

Your recent email dated April 17, to Dr. Francis Collins, Director of the National Institutes of Health (NIH), regarding stem cell research funding, was referred to me for reply. I appreciate the opportunity to respond to your email. 

Across NIH, stem cell research is a high priority. As you know, NIH funds a range of stem cell research, using human and non-human adult stem cells, embryonic stem cells, and induced pluripotent stem cells. NIH-funded research is exploring potential applications in regenerative medicine, drug screening, and the study of the molecular pathways in biological development and human disease. There is no budget set for stem cell research overall or in specific categories; the individual institutes and centers at NIH make their decisions on awarding grants and contracts based on considerations of scientific merit and relevance to their mission, programs, and priorities.

You state that NIH has cut funding for research with human embryonic stem cells under the current administration. That is not correct--NIH has actually increased support by $58.4 million between fiscal year 2008 ($88.1 million awarded) and fiscal year 2012 ($146.5 million awarded). You can find additional details about NIH stem cell research funding at http://stemcells.nih.gov/research/funding/pages/Funding.aspx. 

You may also be interested in reading the NIH Guidelines for Human Stem Cell Research (Guidelines), posted at http://stemcells.nih.gov/policy/pages/2009guidelines.aspx. NIH has approved 209 human embryonic stem cell lines for use in NIH-funded research under the Guidelines. Information on these lines is available at http://grants.nih.gov/stem_cells/registry/current.htm. If you have human embryonic stem cell lines that you think meet the requirements of the Guidelines, I encourage you to submit your documentation for consideration by NIH.

Finally, it is of utmost importance to NIH to conduct high quality peer review. NIH has established a peer review appeal system (see NOT-OD-11-064) to provide investigators and applicant organizations the opportunity to seek reconsideration of the initial review results if, after consideration of the summary statement, they believe the review process was flawed as outlined below. Additional details of this appeals process can be found at http://grants.nih.gov/grants/peer_review_process.htm#Appeals. 

Thank you again for your interest in stem cell research.

Sincerely,

Ellen L. Gadbois, Ph.D.

Senior Policy Analyst

Office of Science Policy

Office of the Director

National Institutes of Health