Monday, November 26, 2012

CIRM Flawed Grant Review --- Financial Conflicts Hostile Override Prop 71 & Stall Stem Cell Research

Although California State Stem Cell Agency -- California Institute for Regenerative Medicine (CIRM) was created by California Proposition 71 (Prop 71), CIRM has never done anything to implement CA stem cell research bond initiative, to prioritize Prop 71 stem cell research, as any government funding agency would or should have done by law. Absence of Prop 71 has been prominently featured in CIRM, from its website, public meetings & events, RFAs, unlawful or special interest eligibility criteria, grant review, grants working groups, scientific grants review officers, scientific reviewers, ICOC meetings, to $ billions of conflicts of interest (COI) awards, to any outcomes or results or publications of CIRM awards. $1.7 billion and 8 years later, California’s Prop 71 stem cell research or human embryonic stem cell (hESC) research remain stalled, stem cell research infrastructure un-built, hESC research lab unfunded, hESC therapy assets of Prop 71 priority unprotected, and promised stem cell therapy development unsupported by designated public/state government funds from Prop 71. For hard-working CA stem cell scientists who have strived to make stem cell research breakthroughs and advances in order to bring CA stem cell initiative as the only hope to many devastating and incurable diseases, as the only hope to those patients whose life-span is measured in months or years, we have never been able to access any support or funding designated by voter-approved Prop 71 to our research and our labs. What we have experienced with CIRM is not the support to our hESC research & advances approved by CA voters, but only a long struggle with the financial conflicts of interest of a flawed grant review process that has no transparency, no implementation for Prop 71, even hostile to hESC research of Prop 71; a long struggle with CIRM flawed grant review process biased towards CIRM board financial conflicts of interest that can only be found in the most corrupted government agency.


Human embryonic stem cells hold tremendous potential for tissue and organ regeneration and function restoration, therefore, provide treatment options and cures for many major health problems and life-threatening diseases that currently have no cure, such as heart disease and failure, diabetes, Parkinson’s disease, Alzheimer disease, ALS, and spinal cord injury. California voters passed a $3 billion stem cell bond initiative, known as Prop 71, for it, which shows that the majority of the public understand the therapeutic value of hESCs. Ironically, it is CIRM and its grants review groups and reviewers that do not understand Prop 71. Not only Prop 71’s hESC research grants applications approved by CA voters are unwelcome by CIRM grant review groups, CIRM external scientific reviewers and CIRM science officers’ merciless negative responses and destructions to hESC grant applications have also proven that CIRM grant review board is negligent, even hostile to Prop 71 (see attachments CIRMPreApp Review & CIRMApp below). To stall Prop 71 stem cell research approved by CA voters, CIRM board has not only issued COI RFAs [e.g., CIRM RFA12-02, 12-3, 12-04, 12-05, 12-09] and set unlawful special interest eligibility criteria [e.g., leadership awards need to be out of state, faculty awards need to have MD] to exclude or block Prop 71 stem cell research from applying for CA voter-approved funding, but has been using unlawful non-transparent Pre-application procedure to deliberately delay hESC research against the law [see CIRMParApp Review below].


CIRM > $1 billion awards to their financial ties without Prop 71 scientific merits are undeniable evidences for anti-transparent, anti-competition, anti-Prop 71, and anti-stem cell research of CIRM flawed non-transparent grant review. Prop 71 states that “Only the 15 scientist members of the Scientific and Medical Research Funding Working Group shall score grant and loan award applications for scientific merit”, however, CIRM board has been using only 5 reviewers not in the Scientific and Medical Research Funding Working Group to bias the selection of grant applications exclusively to CIRM board financial conflicts of interest against the law. Below please see samples of our hESC grant applications for lawful Prop 71 funding that have been deferred by CIRM non-transparent pre-application reviews since 2009 [see CIRMPreApp Review below]. Any single one of our hESC research grant applications meets the scientific merit of Prop 71 and is more crucial & urgent to Prop 71, to advance of stem cell research, and to patients than any grantees in any cycle of those CIRM RFAs. One excuse that CIRM used to cover up its non-transparent Pre-application to defer Prop 71 is that CIRM received too many applications [see CIRMPreApp Review below]. It is hard to imagine that CIRM with $20 M annual state budget, including ~$1 M luxury salaries for a chair and a president who both have been paid more than CA governor by taxpayer’s money, would cry about that they could not handle a few hundreds of applications, among which only a few dozen might have something to do with Prop 71. Among biased comments CIRM used to defer Prop 71, there are PI no drug development experience, reviewer-created COI or anti-Prop 71 or false issues, factual errors, even biased scores on word space information limited Pre-applications using few COI reviewers outside the CIRM grant working group against the law. CIRM has awarded > $1 billion to those without Prop 71 scientific merits using a flawed grant review process to deliberately defer urgent hESC research, so CIRM board members special financial interests to CA Prop 71 for cash help, such as Capricor, UC Davis, Stem, Bluebird, can override Prop 71 and stall stem cell research. Capricor did not have a single piece of scientific evidence that their tissue-derived cells can become beating heart muscle as hESCs do. UC Davis did not address the major issue of immunogenicity for their MSCs and did not have a single piece of scientific evidence that their MSCs can regenerate as hESCs do. STEM did not have a single piece of scientific evidence that their adult cells can repair lost nerve tissue and function as hESCs do. Robbin/Joseph Wu of Stanford U did not generate any approach of deriving cardiomyocytes from hESCs that offers any benefits in efficiency, stability, safety or manufacturing to the other systems as we did. None of those biased comments in CIRM Pre-application reviews that CIRM used to defer CA urgent Prop 71 stem cell research have applied to their COI awards (~ $20 M each) that would be urgent to none but CIRM board members’ special financial gains. 


Why would CIRM CFO Matt Plunkett, former CFO of iPierian, waste $ Ms of CA state funds to withhold Prop 71 funds from commercial validation of hESC assets and therapy using special interest eligibility requirement outside of Prop 71 (see below CIRM application SP1-06442)? iPierian, an iPS cell reprogramming company founded by ISSCR (International Society for Stem Cell Research) board members that include Larry Goldstein’s frequent Harvard guests who severed on CIRM review board, such as George Daley, Amy Wager, Kevin Eggan, Chad Cowan, as well as Deepak Srivastava and Shinya Yamanaka of UCSF & Gladstone, who have not only cooked iPS stem cell fraud research papers using their academy member and editor positions, but have also cooked $Ms NIH & CIRM awards to iPS cells of Gladstone/UCSF & UCSD & Scripps & Cellular Dynamics International, with ISSCR current President Rudy Jaenisch of Harvard and his another protégée Lauren Boyer (on $Ms of Deepak Srivastava NIH iPSC award). If we think David Petraeus’s juicy Pentagon right after the election is shocking exposure, let’s see Irving Weissman’s juicy Pentagon in CIRM. Amy Wager (Harvard, the CIRM reviewer, another woman tied to Irving Weissman of Stanford), Catriona Jamieson (UCSD, ~$30M CIRM awards), Nobuko Uchida (Stem Cell Inc, ~$20M CIRM award), Alexandra Capela (Stem Cell Inc., ~$20M CIRM award), and Tannishtha Reya (UCSD, ~$6M CIRM follow the husband lead award) have juiced Bob Klein & CIRM for hundreds of millions from Prop 71 to Irving Weissman and Larry Goldstein and their consortiums such as Sanford Consortium. No wonder that CIRM lucrative RFAs make Prop71 stem cell research impossible to get lawful public funds whereas give unlawful stem cell frauds the green light (see our previous posts).


We meet Prop 71 eligibility and essential Prop 71 stem cell asset commercial validation criteria that none of CIRM’s funded teams have. Why would CIRM CFO Matt Plunkett want to discuss our eligibility criteria? If we take a look at CIRM board members’ financial disclosure public information, it reveals their far and wide special interest connections, from big Pharms & google venture to a broad range of investment firms. It also reveals CIRM board members’ investment firms’ connections with CIRM grantees’ companies. It is shocking to realize from these public information that, while the public, CA voters, & stem cell scientists are counting on CIRM board members to ensure Prop 71 go to stem cell research, those CIRM board members are actually take-over artists on management team scam & investment fraud to make profit on Prop 71 public fund. If we wonder how a Massachusetts gene-therapy company Bluebird Bio tapped California's stem cell agency for cash help, maybe we should take a look at their investment and management ties, such as Shire Reg Med in Dublin, Ireland and In vivo, to CIRM board members Duane Roth, Matt Plunkett, and chair Jon Thomas. No wonder CIRM keeps deferring Prop 71 stem cell research grant applications using non-transparent pre-applications, so Matt Plunkett & CIRM board members’ own management scam in Bluebird or iPierian can get cash help from Prop 71. CRM board members’ $10Ms or more to take over management control prior to awards, such as Geron, Stem Cell Inc, Viacyte, and Bluebird, have provided the evidences that CIRM $10M special interest eligibility requirement outside of Prop 71 [e.g., CIRM RFA 12-05 & 12-09] is only to sink stem cell biotech and block competition against government anti-trust laws. It is shocking to realize what CIRM CFO Matt Plunkett’s intention to discuss eligibility criteria with Regenerative Medicine Startups of Prop 71 is actually trying to tell our emerging growth startups that we are not eligible according to his COI criteria because we have not been taken over by his greedy management scam yet!


We have been hearing a lot of stem cell scams from companies invited by Stem Cell Meeting on the Mesa (SCMOM) organized by CIRM, alliance for regenerative medicine (ARM), and Duane Roth of UC connect and Sanford Consortium for Regenerative Medicine, which, by contrast, deliberately excluded or blocked Regenerative Medicine Startups of Prop 71 stem cell research (see our previous posts). What makes those snake oil purveyors or stem cell con men, such as Pluristem stem cells in placenta, Medistem & Neostem stem cells in umbilical cord, Cytori stem cells in fat, Histogen stem cells in skin, and Cellular Dynamics iPS fraud, so blatantly seek publicity against scientific evidences? These so-called stem cell biotech companies all share a management scam website that features a well-assembled management team but no stem cells or stem cell research, very similar to the website of Sanford Consortium for Regenerative Medicine of Duane Roth & UC connect. If we take a look at Duane Roth’s investment firm Roth Capital Partners, we would see that these blatant stem cell scam companies sourced from UC connect & SCMOM are actually backed by Roth Capital’s $Ms of big money and management team scam, such as ~$50 M to Pluristem, ~$8 M to Neostem. Duane Roth, the CEO of UC connect and vice chair of CIRM, is also on the board of Sanford-Burnham, former La Jolla cancer institute. If we wonder why Geron would have change of heart to abandon their stem cell programs and solely bet on cancers only < 3 months after Geron received $25M CIRM award. Maybe it is helpful to know that Roth Capital invested $100M to Geron in Dec, 2010, around the same time CIRM RFA 10-03: CIRM TARGETED CLINICAL DEVELOPMENT AWARDS would only accept Geron’s grant and deferred all other applications, even though our hESC therapy product application had better scientific merit to work for patients (see below). In 2011, CIRM & Duane Roth gave Geron $25 M award, even though they knew that Geron’s oligodendrocytes turned into non-functional fibroblasts and had already failed their clinical trial for spinal cord injury, even though they knew that it was waste of $25M of taxpayers’ money and public fund. Similarly, in Dec., 2011, Roth Capital invested $10M to Stem Cell Inc., about the same time CIRM would only accept CIRM board members’ Disease Team Therapy Development Awards Phase II grant applications, while blocked our hESC lawful stem cell therapy development application that had the scientific merit of Prop 71 (see below). It turned out later on that none of those CIRM prioritized Phase II applications had any scientific merit of Prop 71 but COI ties (see CIRM award announcements in 2012). In 2012, CIRM, Duane Roth, and Bob Klein gave Stem Cell Inc. $40 M awards despite that Stem Cell Inc. had no scientific data to back their clinical trial claims and their grants had no scientific merits of Prop 71, despite that they knew that it was waste of $40M of taxpayers’ money and public fund. Roth Capital’s investment and Geron/Stem management team changes, including their CEOs, tell us that CIRM board member Roth had taken over both Geron and Stem’s management and company controls before CIRM & Roth cooked CIRM awards to their own management companies. Roth’s close tie with Sanford-Burnham, a La Jolla cancer research institute, and management control over Geron would explain that Geron abandoned their stem cell programs and solely bet on cancers in Nov., 2011, because their sole motivation to cook $25M of CIRM award to Geron was for their executives’ financial interest to profit on stock/investment/management scam, not even any slightest concerns for stem cell research and waste of taxpayers’ money of Prop 71. Soon after Sept. 2012 when Geron failed their cancer drug, Biotime, a close alliance with Duane Roth/Sanford-Burnham, quickly formed Biotime acquisition to take over Geron’s stem cell assets backed by $Ms of private investment. Their ongoing drama is very likely only the prelude to CIRM next cooked award and their board members’ management takeover scam, at the cost of Prop 71 stem cell research approved by CA voters and taxpayers’ money. Those CIRM board members like Duane Roth & Matt Plunkett have corrupted California stem cell agency and have made big profits on Prop 71/public fund by cooking CIRM awards to their own investment/management scams & stock frauds, while they used CIRM flawed non-transparent grant review featuring biased pre-application [see CIRMPreApp Review below] and their special interest eligibility criteria [e.g., CIRM RFA 12-02, 03, 04, 05, 09] against law to make the gullible public and stem research scientists believe that their greedy hostile takeovers to stall Prop 71 stem cell research are any lawful competition but corruption. Please see attachments at SDRMI wordpress.

1 comment:

  1. Medistem works on Endometrial Regenerative Cells (ERC), not placental or cord blood stem cells, although we have some IP in that area. Please call me directly if you have any questions. I put my number at the bottom.

    Thomas E Ichim, Ph.D
    President and Chief Scientific Officer
    Medistem Inc
    858 349 3617

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