Response to Seeking Public Comment on CSR’s 2022 – 2027

Strategic Plan – NIH

CSR’s draft strategic plan proposes further develop a large cadre of diverse, well-trained, and
scientifically qualified experts to serve as reviewers (goal 2), further develop an outstanding,
engaged, and diverse staff (goal 3), and implement changes to the peer review process to make
it more fair, effective, and efficient (goal 4). However, all seem lacking any concrete plan, which
makes us wonder there is going to be any real improvement on the fairness and transparency of
CSR, diversity and expertise of the reviewers, and engagement of the staff to any biased and
flawed reviews that are detrimental to the reputation, integrity, transparency, and fairness of
CSR. I am an Asian, a woman, got my PhD from Cornell university, owns human embryonic
stem cell (hESC) patents, founder of small businesses. However, with such expertise on stem
cells and regenerative medicine, CSR has excluded me from serving on any relevant review
committees. So far, I haven’t seen a single NIH summary statement that is free of bias, error,
and flaw for a very long time. It seems to have become a common practice for CSR to give out
NIH summary statements that are full of biases, errors, flaws, and baseless or false statements
of those reviewers who have neither expertise nor scientific integrity, who could not even give a
fair, unbiased review to a simple SBIR Phase I grant. For over a decade, CSR have
systematically and intentionally biased the initial peer-review scores of my proposals using a
few reviewers to the bottom half for triage, and would not even bring any of my hESC proposals
up for a fair review by the entire study section. The reviewers’ comments in every single
summary statement of my proposals were full of biases and factual errors, and even highly
conflict of interest (COI) implicated, which indicated flawed reviews and none of the scores
reflected the overall impact and scientific merit of any of my proposals, such as the scores for
the significance unfairly, across-the-board low to even 7, considering that we proposed stem cell
therapy for an unmet medical need that currently has no solution and the project will no doubt
advance human health and dramatically improve quality of life; the scores for the innovation
unfairly, across-the-board low to even 8, considering that we even own patents for the game-
changing technology; the scores for the approach unfairly, across-the-board low to even 9,
considering that this approach overcomes the major bottleneck in the regenerative medicine
market, providing the only available human cell source in large scale and high quality for
neuronal or heart muscle repair in the disease we target, is a highly likely breakthrough one,
and we have established the technical feasibility and scientific merit of the project; the scores for
the investigator unfairly, across-the-board low to even 8, considering that I am the world’s top
stem cell researcher and innovator, highly trained in the proposed hESC research with
inventorship and a record of grants, including NIH center grant and K01 award, to prove my
training, and a track record of publications in internationally recognized peer-reviewed journals
as the corresponding author, and my accomplishments have advanced the stem cell and
regenerative medicine field by demonstrating the direct pharmacologic utility and capacity of
hESC therapy derivatives for human CNS and myocardium regeneration and, thus, presenting
the hESC therapy derivatives as powerful RMAT products for a wide range of incurable or
hitherto untreatable neurological and heart diseases. Even though I addressed the reviewers’
comments in resubmission, the scores in none of my revisions significantly improved, and in
most cases, were even worse with even more issues raised that were full of biases and factual
errors or irrelevant or improper to assessing the fundability of the project. The NIH appeal
system did not do the justice but only left repercussion on my future submissions. In most
cases, I could not even get any responses from my NIH program officers (PO) who usually were
unwilling to criticize the reviewers and correct the factual errors, biases, and the scores. Even
for a few hundred K SBIR Phase I funding that is for prototype development and proof of
concept that I have done, with substantial preliminary data, established technical feasibility and
scientific merit, even with hESC patents and multiple AAP assistances. In contrast, NIH has
misappropriated billions of taxpayers’ money through CSR’s biased and flawed reviews to
induced pluripotent stem cells (iPSC) that are in fact pluripotent cancer cells or adult cells
reprogrammed with multiple oncogenes and have failed safety tests in clinical trials by
causing serious spontaneous mutations and harming patients, including over $200 millions of
NIH iPSC grants/awards to the professors of Broad institute of MIT and Harvard, and multiple
SBIR Phase I & II to San Diego’s iPSC company of UCSD & MIT/Harvard professors with
absolutely no technology/patent. The biased and flawed comments of the reviewers using such
a under-the-table triage process evading the public eyes include: purposely using the fake
sciences of iPSC and factual errors to discredit hESC research; deliberately forcing the grant
applicant using the bogus stem cells iPSC even though they were fully aware that iPSC, the
genetically-engineered adult cells harboring multiple oncogenes, did not work; intentionally
imposing their own wills and scientific misconducts on the applicant; improperly burdening the
applicants with highly controversial and debatable issues that they would not even have open
debate themselves; unfairly devaluing the applicant’s research because the scientific data were
not published in ISSCR’s official journals, such as Stem Cell Report; even threatening the
applicant not improve the scores if the bogus stem cells iPSC were not used. Such opinion
differences regarding iPSC and hESC and their products, regarding the peer-review process of
top-scientific journals, ISSCR official journals, and open-access journals are highly controversial
and highly debatable issues. Those high-ranking, well-connected, well-paid, and well-funded
professors (mostly white, mostly man) would not even allow any open debate about those
issues themselves. It is very improper and systemic racist for the reviewers to impose such
issues and burdens on a Asian woman applicant using such a under-the-table triage process
evading the public eyes; it is unduly unfair and discriminative to intentionally slam an entry level
grant application of a woman to the bottom using such highly controversial issues and highly
biased comments they would not even have any open debate in public themselves; it is quite
fraudulent and unethical to deliberately block a woman’s funding for hESC research using such
a flawed, under-the-table, behind-the-closed-door, pre-application triage process in CSR.
In my most recent SBIR Phase I applications, I proposed to study our hESC-derived cells
(patented) for ALS/heart diseases, in order to overcome the shortcomings and failures of
previous studies, previous cells, and all other stem cells of other PIs. Our cells show high
neurogenic/cardiogenic potential, and all those previous cells show no or low
neurogenic/cardiogenic potential that have caused their failures in functional analysis for motor
neuron/heart muscle regeneration and efficacy study in clinical trials. I even used tables to
compare our neurogenic/cardiogenic cells with those previous non-neurogenic/cardiogenic cells.
However, the reviewers used the previous failed studies of all those non-neurogenic/non-
cardiogenic cells of other PIs and all those problems of their non-functional cells to comment on
my proposal, completely ignoring our preliminary data to show the high likelihood of our cells to
overcome their failures and problems. What kind of scientific review is that? Those are the
intended studies of the proposal, not even done yet, and this is a SBIR Phase I for only a few
hundred K, the reviewers’ critics of those functional studies of those non-neurogenic/non-
cardiogenic cells of other PIs require millions and millions’ funding to fail as they have done
before, totally outside the scope of this SBIR Phase I. There is absolutely no data, no rationale,
for reviewers to make such arguments/comments in the summary statements of SBIR phase I. I
wrote to my PO to point out such unfairness, flaws, errors, and biases of the reviewers’
comments, but could not even get any response from the staff of CSR.

Please see below my letter to Senator Wicker,

Letter to Senator Wicker – “induced pluripotent stem cells -- another scientific Ponzi scheme or
adult stem cell lie”
I write regarding Senator Wicker’s open letter to HHS Secretary Xavier Becerra in June
2021. In particular, their statement “Adult stem cells, induced pluripotent stem (iPS) cells, and
umbilical cord blood cells have been used to create life-saving treatments for multiple diseases
and conditions” is utterly incorrect. Adult stem cells, iPS cells, and umbilical cord blood cells
have not created any life-saving treatments for any diseases and conditions. Most adult stem
cells and umbilical cord blood cells have failed efficacy tests in clinical trials again and again
over the last two decades. And iPS cells are in fact pluripotent cancer cells or adult cells
harboring multiple oncogenes, introduced by the Bush administration and some top
scientists, totally a political stem cell scam. So far, iPS cells have failed safety tests in
clinical trials by causing serious spontaneous mutations and harming patients.
To circumvent the ethical issue of human embryonic stem cells (hESC), induced pluripotent
stem cells (iPSC) were introduced by the Bush administration and some top scientists, including
the former vice president of International Society for Stem Cell Research (ISSCR), Shinya
Yamanaka who ended up winning the Nobel Prize later on, the former president of ISSCR and
Dean of Harvard Medical School, George Daley, as well as the former CEO of Cell Press and
editor-in-chief of Cell and UCLA Associate Dean Emilie Marcus as the alternative of hESC, over
a decade ago. However, iPSC are in fact pluripotent cancer cells, and cannot serve as the
alternative of hESC. Over many decades of studies of cancers with billions and billions of
private and public funding, now we all know that all oncogenes are in fact embryonic genes, or
embryonic genes are known as oncogenes if they are abnormally expressed or activated in
adult cells, and oncogenes cause cancers. What are iPSC? iPSC are adult cells that
abnormally express embryonic genes or are artificially engineered or reprogrammed to express
embryonic genes that are in fact rightfully known as oncogenes in adult cells. So, why should
iPSC be incorrectly called stem cells, while everywhere else in the scientific world such cells are
correctly known as cancer cells? One essential aspect of stem cells is their long-term genetic
stability. Stem cells can maintain long-term, stable growth in culture, while cancer cells grow
abnormally crazy and mutate fast. The initial cluster of iPSC papers was actually published in
top scientific journals, such as Cell, Nature, and Science, in lightning speed, or only a few
weeks, without any scientific evidence or data to show the long-term genetic stability of iPSC or
iPSC could maintain long-term stable growth. And over a decade later, there is still absolutely
no scientific data to show the long-term genetic stability of iPSC or iPSC could maintain long-
term stable growth. Without the data of long-term genetic stability, the line between stem cells
and cancer cells is bleared. In fact, iPSC have been reportedly associated with abnormal gene
expression, accelerated aging, and immune-rejection following transplantation owing to
introducing foreign oncogenes and instability/abnormality to the adult genome, and serious
spontaneous mutations, the sign of cancer cells, have been identified in human iPSC clinical
trials. iPSC are genetically engineered or reprogrammed cells harboring multiple oncogenes,
show seriously adverse effects in patients, mutate as crazy as cancer cells, are absolutely not
safe for any treatment or therapy, and definitely have no commercialization potential or
therapeutic value at all. It is completely fraud and waste, utterly unethical, for public funding
agencies --- Health and Human Services (HHS), the National Institutes of Health’s (NIH), CIRM
--- to misappropriate billions of taxpayers’ money and continue to misappropriate hundreds of
millions of taxpayers’ money to fund such bogus stem cells, which have created absolutely no
life-saving treatment or cure for any disease or condition, but have only largely benefited some
rogue scientists who have neither scientific integrity nor moral fiber. Most of those scientists,
including most of the former and current presidents and vice presidents of ISSCR, are experts
and renowned professors in molecular biology and DNA/histone methylation with full knowledge
that such concepts of iPSC are flawed and iPSC are bogus, but still, they have used their high-
ranking positions, influences, and connections to back and promote iPSC as the alternative of
hESC for their own financial gains, including millions and millions of NIH and CIRM (California
Institute for Regenerative Medicine) funding to themselves and pumped-up stocks of their own
companies. Those iPSC professors and their students sitting in various prestigious
universities/institutions could simply do a DNA methylation or histone methylation analysis to
show the stunning differences between hESC and iPSC, probably would not cost more than a
few thousand dollars. They should know hESC and iPSC are different without even doing any
experiment because the irreversible methylations of DNA and histones in adult cells are well-
documented, and it is common knowledge that simply engineering or reprogramming with
embryonic genes cannot reverse those DNA/histone modifications, only causes instability and
triggers oncogenic processes, and all their research and prestige are based on such
fundamentals. However, they’ve still backed and promoted the fraud and waste of iPSC scam
for their own financial gains. Such as over $200 millions of NIH iPSC grants/awards to the
professors of Broad institute of MIT and Harvard, including Eric Lander --- the disgraced former
science adviser of White House, George Daley --- the Dean of Harvard Medical School, and
Rudolf (Rudy) Jaenisch, the founder of Fate Therapeutics; over $50 millions of NIH and CIRM
iPSC grants/awards to the student of Rudy Jaenisch --- Marius Wernig sitting in Stanford
University; and hundreds of millions of iPSC grants/awards to many of their students sitting in
various prestigious universities/institutions over the Country. Those opponents of hESC
research have benefited so much from the iPSC Ponzi scheme financially and professionally
that catapulted them to high-ranking and high-paid positions, e.g., George Daley to Dean of
Harvard Medical School, Emilie Marcus to CEO of Cell Press and Editor-in-Chief of Cell and
UCLA Associate Dean of strategy, Larry Goldstein to ICOC board, Alysson Muotri to
UCSD/Sanford Center Director, Marius Wernig and Joseph Wu to Sanford Center Directors,
even though none of them have made any medical breakthrough or innovation that would
benefit any patient, nor those billions of NIH/HHS/CIRM grants/awards have generated any
treatment or cure for any disease or condition, even any slight progress in the stem cell field.
We all know hESC are called pluripotent stem cells (PSC) because hESC have unlimited
differentiation potential. Growing evidence indicates that iPSC do not even have unlimited
differentiation potential, the definition of pluripotency, completely false to call such cells PSC.
hESC have unlimited differentiation potential, genomic/epigenomic/cell-line homogeneity,
highly-acetylated and unmethylated, across all hESC lines. iPSC have different differentiation
potential, genomic heterogenicity, cell line variations, because the different tissues they used for
reprogramming have different genomic imprints and are highly-methylated that cannot be
reversed by genes, causing their cell line variations, genomic heterogenicity, different
differentiation potential, and also, most importantly, genomic instability and oncogenic potential.
Deliberately confusing or mixing concepts or definitions or terms, falsely calling something that
is not for funding, are known as scientific misconducts.
There are in fact data fabrication and falsification in all PHS/CIRM funded iPSC research, as
exampled by billions of NIH/HHS/CIRM iPSC grants/contracts, and subsequent a massive
amount data fabrication and falsification published coming out of those PHS/CIRM-funded iPSC
research, mostly in ISSCR journals such as “Stem Cell Report” and “Cell Stem Cell”, some even
in top scientific journals. If the basis is wrong (e.g., iPSC are not stem cells, but in fact cancer
cells), the conclusions or results or any data coming out of PHS/CIRM funded iPSC research
are definitely false or fabricated. For example, it is normal human development for hESC to
differentiate into neurons or cardiomyocytes. If the false and fraudulent statement of George
Daley (iPSC and hESC are identical) could stand, turning iPSC into neurons or cardiomyocytes
would be nothing strange. However, nobody has been able to turn cancer cells into neurons or
cardiomyocytes, or even make cancer cells to differentiate into something, so cancer cell growth
would slow or stop. If anyone made cancer cells or iPSC to differentiate into neurons or
cardiomyocytes, we would have found the cures for cancers. It would be a huge breakthrough.
That person would really deserve a Nobel prize. Why would not we have heard such huge
scientific breakthroughs in the news? In those iPSC professors’ papers or publications funded
by PHS/NIH/HHS/CIRM, they have claimed they turned iPSC into DA neurons (e.g. Marius
Wernig of Stanford University) or cardiomyocytes (e.g., Joseph Wu of Sanford University). If
their claims could not be true, they must have falsified or fabricated a hell out of the data coming
out of PHS/CIRM-funded iPSC research.
To maintain research integrity, it is common scientific practice to do side by side comparison of
data from different cell lines, materials, or sources. hESC are derived from human embryos.
iPSC are reprogrammed from different tissues with different oncogenes. Not only the materials
and derivation sources of hESC and iPSC are totally different, the materials and derivation
sources of different iPSC lines are totally different also. It is intentional, knowing, reckless
research misconduct for data fabrication and falsification in almost all iPSC papers or
publications coming out of PHS/CIRM-funded iPSC research, including those published in top
scientific journals, not to do side by side comparison of data between a iPSC line and a hESC
line, and between different iPSC lines. It is intentional, knowing, reckless research misconduct
for data fabrication and falsification in almost all iPSC papers or publications coming out of
PHS/CIRM-funded iPSC research, including those published in top scientific journals, not to
indicate whether the data were actually from hESC or iPSC, or not to specify which “PSC” line.
As partially revealed by the public statement of Emilie Marcus in her recent vying for CIRM
chair, the UCLA associate Dean of strategy Marcus have plotted and coordinated runs and runs
of CIRM iPSC awards exclusively to iPSC Ponzi scheme professors in CA that Marcus has built
an extensive network of connections through her previous favors as the CEO of Cell Press and
Editor-in-Chief of Cell, including $46 millions to its COMPASS program, also known as shared
iPSC labs, to train the next generation of adult stem cell Ponzi scammers in higher education,
multiple multi-millions of awards to UCSD’s Alysson Muotri who is a close ally of Larry Goldstein
(on ICOC) and a student of Fred Gage of Salk Institute, multiple multi-millions of awards to the
Company of Stanford University’s Joseph Wu, Greenstone. In fact, the CEO of Cell Press and
Editor-in-Chief of Cell Emilie Marcus personally gave the adult stem cell Ponzi scheme or scam
the name “induced pluripotent stem cells”. Shinya Yamanaka submitted that paper for review to
Cell and called those cells “induced pluripotent adult cells”, and Marcus changed the name to
“induced pluripotent stem cells” upon publication without any scientific evidence or data in order
to gain political fame and impact during the Bush Administration. As we know, by definition,
stem cells can both self-renew and differentiate. The difference between “adult cells” and “stem
cells” is that “adult cells” do not need the data of self-renewal and genetic stability, but “stem
cells” absolutely do. And the data of self-renewal and genetic stability are exactly what have
been missing in all iPSC publications or papers.
Funding iPSC is in fact a world-class fraud and staggering waste of taxpayers’ money in billions,
and has generated nothing to advance medicine and improve human health, but only mistrust
and negative images for the public funding agencies --- HHS/NIH/CIRM --- that are neither
transparent nor accountable; it is absolutely unethical to waste billions of taxpayers’ money on
bogus stem cells, such as iPSC. As they said: “Americans expect their tax money to be spent
strategically, but at all times ethically.” CIRM have misappropriated over $ 250 millions of CA
taxpayers’ money to iPSC scam, not even including any funding for shared iPSC labs. We urge
CA State, HHS, Senate/Congress to investigate the fraud and waste of iPSC Ponzi scheme or
scam, to establish oversight to ensure transparent and responsible funding for stem cell
research, to ensure taxpayers’ money to be ethically used to deliver life-saving treatments and
cures for patients, not to be unethically and unaccountably distributed to profit only those few
who are in power.