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.

Monday, November 5, 2012

Cooking Awards --- Sanford Consortium’s Fictitious Stem Cell Research & Directors’ Financial Ties Far and Wide

California Institute for Regenerative Medicine (CIRM) $10M award to Viacyte in most recent round is a laudable positive move towards the right path of California stem cell bond initiative, known as Proposition 71 (Prop 71), on the road to commercialize stem cell therapy for diabetes currently affecting ~ 250 million people worldwide. It is probably the only bright spot among hundreds of millions of CIRM conflicts of interest (COI) awards repressive to Prop 71 that have quickly doubled California state’s debt to > $1.6 billion since CIRM’s new Chair Jon Thomas took office over a year ago. However, it did not come without cooking the financial ties with CIRM Directors. Its advocacy for CA stem cell initiative as cures to type I diabetes patients is also tarnished by CIRM board’s equal amount of COI award to a out of state gene-therapy company Bluebird Bio that has no relationship whatsoever to CA stem cell initiative or Prop 71, but has close ties to CIRM board (e.g., Bertran Lubin) from Oakland CHO/UCs and Sanford Consortium directors (e.g., Larry Goldstein & Duane Roth). Such real financial ties to CIRM directors have also dampened any enthusiasm about CIRM very publicized move to turning CA stem cell initiative into any cures, and raised the eyebrow if CIRM’s initiative to steer towards industry by partnership is only to help CIRM directors to extend their financial ties far and wide, and if it is only to make it easier for CIRM directors to recreate a industry replica for what they have done in academia, which so far has yielded virtually zero results with CA state $1.6 billion of investment.


For simple-minded gullible public, neither Prop 71 nor scientific merit can help understand CIRM $1.6 billion of awards. It is a conflict of interest (COI) phenomenon that can only be explained by their financial ties to CIRM board. The award cooking processes actually started far before CIRM RFAs were even issued. If we wonder how a Massachusetts gene-therapy company tapped California's stem cell agency for cash help, maybe we should take a look at Larry Goldstein & Duane Roth’s stem cell meeting on the mesa (SCMOM) organized by CIRM, Sanford Consortium for Regenerative Medicine (SCFRM), and Alliance for Regenerative Medicine (ARM). Those CIRM future grantees had already been printed on SCMOM invited list a year ago. SCMOM is a meeting full of Sanford directors and their organizers’ academia and industry ties with financial interests to CA Prop 71, therefore, has no room to accommodate any CA’s Prop 71 stem cell research since its inception in 2005. After last year’s SCMOM, CIRM issued 6 consecutive COI RFAs, 3 of which being instructed to boldly exclude Prop 71 stem cell research against the law, to accommodate Sanford directors and their organizers’ academia and industry interests to CA Prop 71 for cash, which shows that Larry Goldstein and Duane Roth’s SCMOM featuring CIRM president Alan Trounson, vice president Ellen Feigal, and chair Jon Thomas as well as Larry Goldstein’s close professional associates (e.g., Craig Venter, Robert Wechsler-Reya, Catriona Jamieson, Vanessa Hayes, Adam Engler, Kristin Baldwin) is not just a simple stem cell meeting as simple-minded gullible public & stem cell scientists would think. The dynamics of their strategic partnership movement afterwards have not been just coincidence. There were Shire or investor partner or capital raising rounds, organized by Duane Roth/UC connect or Janssen or ARM, to companies financially tied to directors of CIRM and/or Sanford. David Davidson from Genzyme moved to Bluebird and forged connections with Oakland & UCLA directors. Duane Roth moved to Sanford Burnham board; Sanford Burnham’s Paul Laikind moved to Viacyte; Evan Snyder of Sanford Burnham moved to the board of Alan Trounson’ company ISCCO; John Reed, Mark Mercola, Clive Svedensen, and Larry Goldstein were met at Sanford Burnham, so they could be all together ready to ripe their cooked awards from CIRM.


Why would, in 2012, CIRM and Alan Trounson still continue to implement a 3 year-old 2009 leadership award for out-of-state fictitious stem cell scientists, while completely ignore any CA stem cell research leaders and their endeavors for Prop 71 stem cell research? We may remember Irving Weissman said something like that he wanted to get all the stem cell experts coming to CA. REALLY? If we know who are among those Irving Weissman had CIRM bribed into CA with public money, maybe Irving Weissman meant to say that he wanted to get all his professional associates coming to CA to help him cooking CIRM awards. Larry Goldstein, as a permanent member on Irving Weisman’s ISSCR (International Society for Stem Cell Research) board, did not just invite Robert Wechsler-Reya once, he invited him so many times that even I could not completely miss his talks. In 2009, in order to understand why he was the only speaker from out of state invited by Larry Goldstein and Alan Trounson, my gullible brain tried hard to find any stem cell research or stem cell in his talk at SCMOM, but did not succeed. It was not until ~ 6 months later when Alan Trounson gave Robert Wechsler-Reya $6 million CIRM leadership award without going through the regular grant review process, we were able to realize that they were cooking CIRM leadership award at SCMOM. But I still could not understand why Larry Goldstein, who is notoriously repressive to stem cell research at UCSD and SCFRM, would be so fond of Robert Wechsler-Reya and his wife, not only guaranteed a out-of–state person without any stem cell research experience $ 6M from CA state stem cell initiative to become Tumor Program Director at Sanford Burnham, but also had his wife promoted to professor at UCSD Pharmacology Department. It was not until Robert Wechsler-Reya wife’s professional tie to Irving Weissman became unveiled, just like Catriona Jamieson, Fred Gage, and some others around Larry Goldstein and Duane Roth, I could realize why Larry Goldstein and Duane Roth guaranteed their residency at SCFRM, while despotically claim SCFRM, built with public state money for stem cell research, cannot accommodate any San Diego’s stem cell research against law. Without their professional and financial ties to ISSCR, CIRM & review boards, ARM & big Pharms, even NIH, without their constantly inviting/bribing their COI ties & forging/polishing COI strategic partnership in the name of stem cell meeting/research, it is hard to imagine that, with virtually no stem cell research results, Larry Goldstein & Irving Weissman’s inner circle could be able to snap up > $500M cooked awards from CIRM just for those who have direct connection to ISSCR board, including ~ $40M to Larry Goldstein and his associates, ~ $ 70 M to Irving Weissman and his company, ~ $30 M to Catriona Jamieson and more to other offspring or professional associates of Irving Weissman.     


If we, the people, and the government for the people, count on Duane Roth and other CIRM directors to do their job, to ensure Prop 71 cash go to stem cell research, not to their own COI ties, what they have done and what SCMOM have accommodated are telling us that we are mistaken. The one thing SCMOM invited speakers share in common is not stem cell research, but their far and wide professional and financial ties to Larry Goldstein and Sanford directors. SCMOM should be called CIRM grantee meeting, because it accommodates CIRM past and future cooked grantees. If the public and CA state government wonder where our $1.6 billion has gone to and why there is no result, it is the meeting they should attend. It is the meeting not showing progresses/advances of stem cell research, not showing cures/hope for patients, but waste of hundreds of millions of public/state money on useless research or Sanford consortium fictitious stem cell research, and continuing waste of hundreds of millions of public/state stem cell research money on waiting cooked awards for CIRM COI RFAs on iPS/adult cells. It is a meeting that the Nobel committee should also eavesdrop too, because then they could hear the truth about those so-called biggest breakthrough of adult stem cell research hailed by opponents of Prop 71 stem cell research, hear that the induced pluripotent stem cells (iPS cells) are actually useless for patients, having structural defects, oncogenes, genes for diseases & tumors, mutations for genes maintaining genomic stability, etc. SCMOM could accommodate flies (e.g., Leanne Jones of Salk Institute), mouse/adult cells (e.g., Alessandra Sacco of Sanford Burnham/Stanford), cancer (e.g., Robert Weschsler-Reya of Sanford Burnham, Catriona Jamieson of UCSD), and iPS/adult cells (e.g., Kristein Baldwin of Scripps, Ken Zhang of UCSD, Vanessa Hayes of Craig Venter, Birgitt Schuele of Parkinson’s institute). SCMOM could accommodate stem cell research imposters and stem cell conman’s big claims with virtually no data (e.g., Fyodor Urnov of Sangamo’s cardiomyocytes from pluripotent cells). SCMOM could not accommodate Prop 71 stem cell research but something close to a hoax that our taxpayers should not have to pay.