Sunday, December 9, 2012

For those who missed out on the controversy...

Texas cancer institute to re-review controversial grant

Ronald DePinho and Lynda Chin
The largest grant to date from one of the world’s major institutional funders of cancer research will be re-reviewed, officials overseeing the award now say, even as the grant’s high-profile recipients steadfastly assert the money was fairly awarded and would be well spent.
The Texas cancer world has been rocked by controversy since the 8 May resignation of Alfred Gilman, a Nobel laureate and chief scientific officer at the US$3-billion, taxpayer-funded Cancer Prevention and Research Institute of Texas (CPRIT) in Austin.
In leaving, Gilman cited his concerns about an $18-million “incubator” grant speedily awarded in March, without scientific review, to a team at the Institute for Applied Cancer Science (IACS) at MD Anderson Cancer Center in Houston.
The controversial grant’s purpose is to build infrastructure that will speed the development of cancer drugs by, among other things, expanding the small-molecule pipeline to include biologics, and boosting current target biology and small molecule discovery efforts. (Rice University in Houston, a partner with the IACS, would receive $2 million as part of the same award.)
Lynda Chin, the cancer researcher who was listed as principal investigator on the IACS team, is the IACS scientific director and is also married to MD Anderson president Ronald DePinho. The couple moved to the huge institution last August from the Dana-Farber Cancer Institute in Boston, Massachusetts. At that time the lines of authority governing Chin’s reporting, potential promotions and salary were outlined in this e-mail to her and DePinho from Kenneth Shine, the executive vice-chancellor of health affairs for the University of Texas system.
In his resignation letter, Gilman complained that the CPRIT had in March sidelined seven scientific grants that had already been reviewed and recommended and were worth $39 million.  He added that he would stay on in the job for several months “to champion the research slate” and “to prevent further award of vast funds for research programs ostensibly within incubators that were not described and therefore could not have been reviewed.”  A subsequent letter to the CPRIT oversight committee from its scientific-review council, headed by biologist Philip Sharp of the Massachusetts Institute of Technology, called the 6.5-page incubator proposal from Chin and colleagues “research,” even if “strikingly lacking in specific[s]”. “We are surprised and disappointed by the failure of proposals of this sort to receive scientific (research) peer review,” the committee wrote.
The CPRIT’s decision to re-review the grant emerged during a quick exchange of letters in which DePinho offered to have it vetted again and William Gimson, CPRIT executive director, agreed to take up the offer in his same-day response.  However, Gimson’s letter makes clear that, as with the first review, it will be conducted by the CPRIT commercialization review council — the panel that passed muster on it the first time — and not by scientific reviewers.
DePinho and Chin both agreed to speak with Nature yesterday. Here is a condensed version of their remarks:

What is your version of what has happened that has led to the current controversy?
DePinho: Long before we arrived in Texas there was a good debate [at CPRIT] as to the balance of [spending on] research and commercialization and prevention. There were new programmes that CPRIT embarked on: incubator projects. This led to a request for applications (RFA).
Many people said to us: you really should consider applying. We were not even considering it.
The application was a business plan. It was clear they did not want the science. They assumed the science was strong. We had a very very strong track record in that regard.
The next thing that occurred was this firestorm of concern from Dr. Gilman. And I understand frankly that he went through a very rigorous process of recommending funding for [research] grants. And then priorities were set at the level of CPRIT that impacted on the ability to fund all of those grants.  And they were very understandably upset.
But the reality is: we applied for an RFA, we worked with people who encouraged us to do this… It was reviewed and it got funded. The process… was done in a way that was totally consistent with CPRIT’s guidelines.
There’s a lot of concern that something nefarious was done. And I believe that’s unfounded. The facts will speak for themselves. And I am happy to have the grant re-reviewed by anybody.
Your wife is listed as the principal investigator on the $18-million incubator grant.  Some in the public could perceive this to be a nice tidy deal for both of you. How do you respond?
DePinho: It’s important to note that Lynda reports to Ken Shine, the [executive vice-chancellor of health affairs] at the University of Texas system.  She doesn’t report to anybody within the [MD Anderson] organization.
Second, [MD Anderson] committed $75 million over five years [to the IACS] and one of the things that it encouraged this group to do was to apply for grants to enhance their programme.
Realize that it was a team of half-a-dozen individuals, including Lynda, that submitted this grant. How Lynda ended up as the PI, I do not know.
I understand that the optics of this — that people would raise some questions… . [But] this was a grant going to an institute supported by a team acting on a mandate from the [MD Anderson] institution to secure grants.
What do you think should happen next?
DePinho: The important thing is to not throw out a baby with the bathwater; to make sure things that are worthy of funding, including those research grants that fell below the payline, get supported. At the same time, I believe that the IACS will go down as one of the best investments in the CPRIT portfolio.
The guidelines are the guidelines and we adhered to them. They can always be improved.  But to characterize this as a flawed process and to cast aspersions on individuals that were doing what they were supposed to do is not helpful to anybody.
To Lynda Chin: What do you think has engendered the current controversy?
Chin: I frankly am somewhat mystified as to how this controversy arose. If you go back to the CPRIT’s RFA online, it specifically was requesting a business plan for an infrastructure to support commercialization. And the IACS is a unique entity: the best way to think of it is as a business within MD Anderson.  And it’s the only entity at MD Anderson that qualified to respond to this RFA as a team.
If there was controversy over how the incubator infrastructure grants should be approved, that should have been within CPRIT. Because the RFA specified how this business plan was going to be reviewed. We as a team could only go by what the RFA said.
You said just now that IACS is a business. But you have no products or company name. How do you defend that definition?
Chin: That’s very straightforward. The business plan for the IACS was developed, reviewed and approved by the [University of Texas] system prior to our final recruitment to MD Anderson in August last year. It mandated milestones we have to meet, deliverables that include drugs that will eventually help patients, and requirements to deliver funds… . It dictates the type of people we will recruit… who will execute a work plan to generate a product — not to publish. I can tell you there’s no research lab that operates that way.
What do you say to a Texas cancer scientist who applied through standard CPRIT channels for research funding and failed to win it? Who feels, now, unfairly dealt with?
Chin: Look at the mandate of CPRIT. It was funded by taxpayers for prevention, commercialization and research… . It was built with three different review councils to address [these] three different aspects.
I do research. I understand and absolutely support the importance of basic research, because there’s so much we don’t know. And until we do, we can’t fully conquer cancer. Having said that, no single Cell, Science or Nature paper has ever cured a patient, until [it’s converted] to a drug, a test or a medical device… . To the scientists who say this is not fair, I would remind them that our goal here is to help our patients.
Your husband is in a powerful role — and some might say there’s an appearance here, fair or unfair, of money gravitating to power.  How do you respond?
Chin: The business plan is for the IACS. The IACS is a team effort. This team is mandated to bring in external funding. I am only one member of that team. The funding is not something that I will use for my research programme. I have separate research programmes that require separate funding. My trainees will not benefit from this funding. This is specifically going into the institute.
What would you like to see happen next?
We believe this award of infrastructure will ultimately deliver tremendous benefit to the patients. I would like to see MD Anderson and CPRIT get to the point of negotiating a contract.


Ally Kanamisa said:
I would like to thank Dr Chin for her openness to respond to the questions posed by Nature . It is apparent to me that getting to the point of negotiating a contract for your hybrid “academic-industry model” requires to not bypass the rules or authority (Provost) sustaining the integrity of organizational and regulatory components of those two units( academia-industry). Remember that the main and ultimate target of this hybrid model is a human being, cancer patient, who needs a cure. And commercialization, as intended by the taxpayer, revolves and evolves around her/him.
In regard to your statement that the business plan was approved by UT before your final recruitment, my question is: do you see this award, then, as part of your start up funds?. I seem to understand from your statements that the answer is NO. It follows that your application (in response to the RFA), is in the context of a hybrid model to serve cancer patients and should contain not only a business plan but also a scientific plan. By the way, in the RFA is stated:
“Does the Applicant propose a sound program evaluation plan, including scientific review, commercial viability, milestone measures, expected deliverables, and required accomplishments? ….”
It is difficult to understand the approval of an incubator award requiring to proposed scientific review that has not being reviewed by scientific peers in the first place.
Allow me to tell you that I also feel mystified by your husband assertion: ““The application was a business plan. It was clear they did not want the science. They assumed the science was strong. We had a very very strong track record in that regard.”. It seems to me that business people and lay people may assume that the science is strong. However, we scientists are taught that “ in science you don’t take anything for granted”. That’s the expected attitude of a scientist and implies to expose oneself to the scrutiny of peers to endorse our proposals.
Dr Chin, you appear to be an incredible woman scientist. There is no reason for fear to expose your scientific ideas and plans. Please, complete your proposal and resubmit it for review. It is in your best interest and that of your credibility. And set up an example for the state of Texas, the country and the world.
Thank you and I wish you the very best
PS to Nsture: In the letter from Gimson it is stated” Incubator RFA is designed for commercial ventures and any proposal submitted must comply with that criterion”.
Commercial ventures are not to be exempted from specified and clear ethical guidelines. In particular, when commercial ventures claim to have as main, though not only, objective the treatment, cure and safety of cancer patients. There must be objective, well defined, parameters to comply with in order to ensure that the population is at minimum risk when it comes to her health and ECONOMICS. We are globally suffering the devastating consequences of a financial crisis and “there are lessons to be learned from the process” . This is a quote from correspondence between Gimson and DePinho: “These commercialization incubator awards are uncharted territory for all of us and there are lessons to be learned from the process. For example, at MD Anderson should not be reviewed by the Provost’s Office but by the Business Affairs and we are instituting this process.”
We don’t need to set up a very questionable precedent.
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