Showing posts with label snyder grant. Show all posts
Showing posts with label snyder grant. Show all posts

Sunday, March 14, 2010

California Stem Cell Matters: What Do You Think?

Evan Snyder of the Sanford-Burnham Institute takes issue with the headline we wrote last Thursday concerning CIRM approval of more cash for his research.

The headline read: “Burnham's Snyder Receives $1.85 Million More Despite Faulty Application.”

The full text of his remarks can be found in the item below. He says the headline uses “pejorative phraseology” and “betrays an absence of journalistic impartiality.”

We responded to Snyder in an email and offered to run his comments verbatim. We gave him and are now passing along to all our readers some thoughts on what we do on this web site and what can be expected by our readers and those we write about.

We appreciate Snyder's point of view and understand where it is coming from. However, the blog has never pretended to be "objective." It offers commentary, news and information on the matters dealing with the California stem cell agency. Because of the dearth of third-party information on the agency, I do considerable basic reporting and information-gathering, far more than is done by most bloggers. I also provide explanation and analysis of the information that is gathered. And, yes, I offer my opinion from time to time.

That said, many legitimate points of view exist on these matters, including Snyder's. I am more than glad to carry his remarks as well as those last week. They provided an important addition to understanding how research comes about.

One of the major weaknesses of the mainstream media is their inability to provide ample room for many points of view. One of the strengths of the Internet is that it provides a venue for many more voices, something we encourage on the California Stem Cell Report.

For some time now, CIRM Chairman Robert Klein and CIRM President Alan Trounson have had a standing offer from us to run verbatim their comments on stem cell topics of their choice. Recently, we notified all the CIRM directors that they have the same opportunity – something that does not occur in the traditional, mainstream media. In addition, we encourage comments directly on items, which can be done by clicking on the word “comments” at the end of each piece. We encourage readers to use their names when they provide commentary, but understand that in some cases important comments can be made only anonymously. That has to do with the tiny size of the California stem cell community and the extremely powerful financial role that CIRM plays in it.

Feel free to comment on this item or simply send me your thoughts via this email address: djensen@californiastemcellreport.com.

Snyder says CSCR Headline Lacks Impartiality

Here is the text of Evan Snyder's remarks concerning the following headline – “Burnham's Snyder Receives $1.85 Million More Despite Faulty Application” – on the item on March 11, 2010.
“I would have to say that the headline you used betrays an absence of journalistic impartiality. I gather from the perjorative phraseology that you have a point-of-view on this issue and are not sitting as a disinterested chronicler. Had you been that -- which I mistakenly assumed you to be -- you would simply have stated the facts -- 'Snyder awarded grant for Parkinson's research'. However, you did not. Rather you injected yourself into the story. I was actually trained in journalism as early as high school, and my instructors would have castigated me for such a headline.

“I, and the scientists who reviewed our proposal, see this proposal as not in the least flawed. Indeed, I (and most who have studied its aims) find it to be among the most scientifically rigorous, predictive, expeditious, parsimonious, and cost-effective study ever proposed in the stem cell field for Parkinson's disease with any hope for answering long-simmering scientific questions and advancing rational and safe treatments to California citizens suffering from this horrible, debilating disease. Every aspect was spelled out in detail from moment #1; no aspects were hidden. California -- as represented by the study section, CIRM, and the ICOC -- recognized the golden unique opportunity to move the field forward for its citizens and appropriately, sagely, and responsibly seized it. Hence, I find 'zero' flaws in this application. My headline would have been very different.”

Saturday, March 13, 2010

Nature Blogger Writes About Snyder Grant

One of Nature magazine's blogger wrote briefly this week about the Evan Snyder affair at the California stem cell agency.

Referring to our article on the grant, Elie Dolgin said on the site, Spoonful of Medicine.
"Here’s one creative, albeit seemingly accidental way, to get a 50% boost for your multi-million dollar research grant: Flout the rules, say you’re sorry, and then argue that you can only make up for it with extra cash. "
You can read Dolgin's entire item here.

Thursday, March 11, 2010

Burnham's Snyder Receives $1.85 Million More Despite Faulty Application

Directors of the California stem cell agency this morning, on a split vote, approved a $1.85 million increase in a grant to a Southern California scientist after he submitted a proposal that would violate the agency's rules against spending CIRM funds out-of-state.

Nineteen directors of those present voted in favor of the increase, although some expressed concern about the way in which the application was processed. CIRM did not announce the number of negative votes, but they appeared to be only handful, based on what could be heard via the Internet audiocast of the meeting. The board has 29 members but not all were in attendance.

The motion to approve the increase also included a requirement that CIRM staff work with the board to improve the way in which applications are screened prior to approval by the board.

The CIRM staff made the recommendation for the 50 percent boost (for a total of $5.4 million) in the grant to Evan Snyder (see photo) of the Sanford-Burnham Medical Research Institute in La Jolla. Last April CIRM directors approved a $3.6 million award to Snyder without knowing that it would violate the explicit ban on non-California spending. The staff said the additional money was needed because of the increased cost of moving the work to California.

A straight-forward explanation of how the grant came to be approved, despite its out-of-state component, was not available prior to today's board meeting.  Nor was it today. But some details emerged during this morning's discussion. Scientific reviewers, who make the de facto decisions on grant applications, were aware that Snyder's application involved paying for work out-of-state. That information did not reach the staff level until it surfaced during a regular review following approval last April of the grant by the CIRM board.

Based on the board discussion today, the key difficulty appeared to be with a subcontract with Eugene Redmond of Yale University. Snyder mentioned Redmond in his statement to California Stem Cell Report, saying that Redmond is in the process of becoming an adjunct professor at Sanford-Burnham and will spend one week a quarter in La Jolla.

Claire Pomeroy, a CIRM board member and dean of the UC Davis medical school, said that Snyder's revised proposal replaced senior researchers with junior scientists. She said the reviewers' score on the grant might have been different if they had known last year about the use of less experienced researchers. Pomeroy also suggested that Burnham pick up some of the additional costs, but CIRM President Alan Trounson said the institute would not do that.

Other board members worried about fairness issues along with their concerns about how grants are vetted by staff prior to being examined by CIRM's grant review group. Board member Joan Samuelson, a patient advocate with Parkinson's Disease (the subject of Snyder's research), said she supported the grant. But as a condition, she said the staff must “continue the discussion” with the board about how to avoid situations like this in the future.

At the end of the board debate, CIRM director Sherry Lansing, a UC regent and former head of a Hollywood movie studio, said she was still confused about how the Snyder grant was handled and asked to be briefed later about the matter.

No dissent was heard from CIRM board members about the value of the research proposed by Snyder. Director Jeff Sheehy, a patient advocate and communications manager at UC San Francisco, said,
“This is incredibly important science.”
Sheehy warned the board against becoming bogged down “in process.”

You can read more about the Snyder grant, including statements from Snyder and others by searching on the label “snyder grant.”

Snyder Provides Additional Comment on Out-of-State Spending Proposal

Evan Snyder of the Sanford-Burnham institute has emailed additional comment on his grant proposal, which this morning comes before the board of the California stem cell agency. His response came after we asked him yesterday: "How did you happen to propose spending CIRM money out of state? The agency clearly bans such actions and explicitly states that in its instructions to applicants."

Here is the text of Snyder's most recent remarks.
"As a California scientist, I wrote the strongest scientific application possible for performing a clinical trial on Parkinson's Disease in California. Having justified each step, each experiment, each reagent, I let the scientists on the Study Section vet it, and make a decision. Recognizing that performing these experiments in this manner was the only way that a clinical trial for Parkinson's Disease would ever reach fruition in California (or anywhere else in the world), not wishing to let Parkinson's patients suffer, and knowing that, other than procuring NHPs from the optimal source, the substantive work was being done in California, the Study Section recommended that the proposal be funded. In fact, they called it a "tour-de-force".  NHPs are necessary for Parkinson's Disease research work; the proper NHPs are not available in California. The alternative is for California to decide to ignore and not treat Parkinson's Disease at all for its citizenry, an unacceptable proposition to most compassionate voters. All research will be done in California.
            "As to the Australian involvement, that was simply based on CIRM’s well-established Collaborative Funding Partner Program. A partnership had been created between California and the Victorian government before the grant was written. Collaborations were encouraged. However, no CIRM funds will be used in Australia. The Victorian government determined that, if Australian investigators collaborated on a meritorious California project, the Victorian government would pay all of the expenses of the Australian component of that collaboration.
            "So, the answer is that CIRM is paying only for research done in California."

Wednesday, March 10, 2010

Murky Backdrop on $5.4 Million Grant to Burnham Scientist

Directors of the California stem cell agency tomorrow will be asked to approve a $1.85 million increase in a grant to a Southern California researcher after he filed a proposal that violated CIRM's rules against spending CIRM funds out of state.

The CIRM staff made the recommendation for the 50 percent boost (for a total of $5.4 million) in the grant to Evan Snyder of the Sanford-Burnham Medical Research Institute in La Jolla. Last April CIRM directors approved a $3.6 million award to Snyder, apparently without knowing that it would violate the explicit ban on non-California spending. The staff said the money was needed because of the increased cost of moving the work to California.

John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., called on directors to reject the grant outright. To do otherwise, he said, would be “extremely unfair to other applicants who followed correct procedures.”

In a statement to the California Stem Cell Report, Simpson said (full text available here),
“Either the applicant deliberately flouted the rules requiring all research to be done in California and thought he could get away with it or he didn't understand the rules. In either case he did not follow them.

“Assume the best and, unlikely as it seems, grant that a top California researcher and his institution didn't understand CIRM's regulations. But just as ignorance of the law is no excuse, ignorance of the rules governing CIRM awards is no an excuse for not following them.”
In response to a query, Snyder defended his proposal. He said the proposal uses California taxpayer funds "in the most economical and frugal manner possible.” He said Simpson “is misinformed about the most parsimonious way of stretching California biomedical research dollars during hard financial times. CIRM and the ICOC(CIRM directors), in fact, exerted exceptional fiduciary (not to mention scientific) responsibility in awarding this grant. They awarded the contract to the lowest bidder.”

Just how all this came about is a bit murky. CIRM shrouds its grant-making process in secrecy. Names of grant applicants are not revealed until after the winners are approved. Names of rejected applicants are never disclosed. Even today the CIRM staff information on the Snyder grant that is being presented to directors tomorrow does not include his name or the name of his employer. However, that information was given to directors last April as part of its “extraordinary petition” process. The staff report itself became public on the CIRM Web site only three business days prior to the CIRM board meeting in Sacramento.

Asked for a comment, Don Gibbons, chief communications officer for CIRM, said “The budget for the California researcher included a research subcontract to a U.S. organization outside California. CIRM followed standard practice for this funding round, performing a detailed budget review of each proposal approved by the board. When it became clear that this proposal included a subcontract that CIRM could not fund, CIRM asked the PI if the proposal could be revised to meet CIRM funding requirements.”

Gibbons did not respond directly to a question about how an application proposing out-of-state spending came to be approved by the board. (More of Gibbons' response can be found here.)

Gibbons also did not respond to a request for the identity of the non-California recipient originally proposed by Snyder. But in Snyder's response (full text here) to the California Stem Cell Report, Snyder refers to the St. Kitts Biomedical Research Foundation in the Carribean. Snyder said it is “the best non-human primate facility for Parkinson's Disease research in the world.” However, it is unclear whether that was out-of-state spending identified by CIRM.

The Snyder grant poses some important questions for CIRM directors.

Should they reward a researcher who failed to follow CIRM rules?

Would that be fair to other applicants?

Should CIRM President Alan Trounson have been involved in the review of the proposal, which has collaborators at Monash University in Australia, an institution where Trounson presided over the stem cell research program? Presumably a failure to fund Snyder would have a negative impact on his Australian counterparts(Trounson's former colleagues), although they are not funded by CIRM.

How does the situation affect the public perception of CIRM? Snyder's boss, John Reed, the president of the Sanford-Burnham Institute, sits on the CIRM board although he cannot vote on the grant or even take part in the discussion about it. Should Trounson take part in tomorrow's discussion of the Snyder grant?

Would the situation have been handled in the same fashion if the grant applicant had been from a less illustrious institution, such as UC Merced?

Is the research so compelling and urgent that it overwhelms any sort of negative reaction? Or would it be better to defer the issue until additional information is available to directors and the public?

These questions should be considered in the context of a recent chorus of recommendations for more transparency and accountability on the part of CIRM. (See here, here, here and here.)

Text of Simpson Comment on Snyder Grant

Here is the text of the statement from John M. Simpson, stem cell project director for Consumer Watchdog of Santa Monica, Ca., concerning the Evan Snyder grant.

“Either the applicant deliberately flouted the rules requiring all research
to be done in California and thought he could get away with it or he didn't
understand the rules. In either case he did not follow them.

“Assume the best and, unlikely as it seems, grant that a top California
researcher and his institution didn't understand CIRM's regulations. But
just as ignorance of the law is no excuse, ignorance of the rules governing
CIRM awards is no an excuse for not following them.

“Granting this award would be extremely unfair to other applicants who
followed correct procedures. The ICOC should reject this grant. If he can
figure out how to follow the rules, then the researcher can apply the next
time a similar RFA is issued.”

Text of Snyder Comment on his CIRM Grant

Here is the text of Evan Snyder's response to a request for comments involving his CIRM grant.

“Actually, contrary to Mr. Simpson's assertions, this project uses the funds of California's taxpayer's -- particularly those who suffer from Parkinson's Disease and other neurodegenerative diseases -- in the most economical and frugal manner possible. The only authentic model of Parkinson's Disease that is predictive of how patients will respond to therapy -- both in terms of benefits and side-effects -- is the non-human primate model. The best non-human primate facility for Parkinson's Disease research in the world is the Axion/St. Kitts Biomedical Research Center. This facility, which has been studying Parkinson's Disease for ~30 years, was, in fact, chosen as the Michael J. Fox primate facility for precisely this reason. Not only is this facility the best in the world, but also the most inexpensive. No primate facility in California was able to match its cost, match its expertise and scientific rigor, or match its facilities. UC-Davis, the only competitive primate facility in California, is not capable of maintaining this model of Parkinson’s Disease, particularly the enormous amount of care of vigilance required. Indeed, UC-Davis does not even house the African Green Monkey which is required; rhesus monkeys are known not to offer the same predictive value. (As might be recalled, the first clinical trials using fetal tissue in PD failed to an extent because representative preclinical animal models were not used, a problem eliminated in this proposal.) It would take a number of years for UC-Davis to bring their facility up to the level of excellence required by these studies (which could lead directly to clinical trials). Furthermore, they would need to charge 300% the cost being devoted to the animal studies now; in other words, for the same amount of work, this project would need a budget nearly 3 times its present budget with a delay in its work by years. The African Green monkey furthermore requires a near tropical climate with indigenous tropical fruit and housing in an open free-ranging, colony setting. That climate or housing demands cannot be created in California.
“There is a long experience in California – including via CIRM – for obtaining animal models from the facility that produces the models the best. For example, mutant mice and other specialized murine models are obtained from Jackson labs -- even though it is in Maine -- because that facility produces the animals required. (I should mention that Axion/St. Kitts Biomedical did have a California office in its early days and will be renewing that). The only CIRM-funded work being done out of California on this project are those tasks that require a living animal -- i.e., transplantation, behavioral assessment, and possibly imaging. Once a living behaving animal is not required, all study materials are transported back to California for the real scientific analysis. This is done only by California scientists and staff. Dr. Redmond, the only key personnel member on the team not presently a permanent California resident, manages the facility and performs the surgeries and, hence, must be on site; nevertheless he is in the process of becoming a formal Sanford-Burnham adjunct professor (he has served in that role informally for a number of years). Furthermore, for one week each quarter, Dr. Redmond will live in California working with the team to further analyze the data -- the real purpose of the proposal.

“Hence, Mr. Simpson is egregiously mistaken about the nature of the grant and, most importantly, about the nature and requirements of Parkinson's Disease research that has any chance of aiding California patients. Furthermore, he is misinformed about the most parsimonious way of stretching California biomedical research dollars during hard financial times. CIRM and the ICOC, in fact, exerted exceptional fiduciary (not to mention scientific) responsibility in awarding this grant. They awarded the contract to the lowest bidder. And California is not only getting the fruits of arguably the best Parkinson's Disease research team in the world using the best Parkinson's Disease model that exists, with the shortest trajectory to treatments, but is getting it at the lowest price available in the world. Given these facts, one is lead to question Mr. Simpson’s true concern for the disease sufferers in the state as well as his concern for the most parsimonious use of taxpayer money.”

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