The director of the Cedars-Sinai Heart
Institute today asked the governing board of the California stem cell
agency to approve his application for $13 million for heart research,
declaring that the agency's review of the proposal was tainted by a
conflict of interest.
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| Eduardo Marban Cedars-Sinai photo |
In a letter, Eduardo Marban
contested the findings of a CIRM staff review of the conflict
allegations. He said,
“The initial review was tainted by conflict of interest concerns. The re-review was conducted by staff in a peremptory manner without the usual CIRM due process: no patient advocates were involved, no comparator grants were evaluated, and no formal review reports have been provided. Only a pithy, dismissive summary by CIRM staff has appeared, and that only yesterday.”
Marban's application was the subject of
an article on the California Stem Cell Report yesterday, which
discussed the lack of transparency in the agency's grant review process, particularly in relationship to conflicts of interest. The
application was quietly removed from CIRM board consideration in
December and has been placed on the board's agenda for action
tomorrow in Burlingame, Ca.
The agency withheld Marban's name, the
names of reviewers and the nature of the conflict charges. Marban did
not go into specifics concerning the conflict in his letter today. We
have emailed him, seeking details.
Marban has previously received $7
million for research from the agency. Capricor, a company he founded,
has received $20 million. The company is scheduled to be highlighted in
tomorrow's CIRM governing board meeting as one of its success
stories.
In his letter, Marban noted his previous research along with the latest proposal and its clinical potential, an increasingly
important consideration for the CIRM board. Marban wrote,
“The commercial potential of (the earlier funded product) has been validated by a collaborative/option agreement between Capricor (the company I founded to develop regenerative therapeutics) and Janssen, an arm of the pharmaceutical giant Johnson and Johnson. This represents the first time that 'big pharma' has partnered with a regenerative medicine biotech to develop a product.”
Marban also said,
“The present proposal (DYNAMIC) is ready to go into patients immediately; it is FDA and IRB approved. In fact, we have a list of 30+ patients who are waiting to be screened for enrollment, as soon as funds are available. These patients are ill, with a mortality exceeding that of many cancers. Indeed, several eligible patients have died in the interlude between the last ICOC meeting, when this proposal might have been funded, and the present.
“DYNAMIC would be the first study in the CIRM portfolio to target hard clinical endpoints (mortality and re-hospitalization) in a very high-risk population (that of advanced heart failure). The population to be studied is very different, and much sicker, than in the ALLSTAR trial.”
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