publication date: Jul. 8, 2016

Slamming the Door

Part XIV: How Al Got It Right

 

Gilman’s resignation enabled him to retain the most precious of all privileges: the ability to look at himself in the mirror.

By slamming the door loudly and publicly—and by triggering an impossible-to-ignore resignations of scientists who conducted peer review at the Cancer Prevention and Research Institute of Texas—he made it clear that the institute’s scientific review was in danger of being subverted, and that its funds were at risk of being raided by politicians.

“I built something I am proud of, and now it’s being taken apart,” Gilman said to me at the time. “I can’t work for people who are pushing their own interests at the expense of the interests of cancer patients.

“A wise and experienced friend said to me: ‘This is always the way it works when you put a large amount of public money on the table. The vultures and the hyenas lie low for two or three years to see how the system really works. And then they come in for their feast.’”

Gilman accepted the fact that he had no control over the events that followed his exit. He believed that two changes would have to be made for the institute to become viable again:

(1) Bill Gimson, the executive director who shepherded MD Anderson incubator proposal through peer review, would need to go, and

(2) The politically appointed CPRIT Oversight Committee would need to be jettisoned as well.

Anything short of that would be insufficient. But of course, nothing of the sort could possibly happen, he said initially. By then I knew that in the case of Al Gilman, the verbs “said” and “believed” could be used interchangeably.

Initially, Gilman thought the chance of either of these events occurring was somewhere around zero. Even if a good scientist is found to replace him as chief scientific officer, this person will have to battle politicians.

His refrain: “Never underestimate the power of Texas politicians to fuck things up.”

 

 

If anything, following Gilman’s resignation, Texas politicians seemed to be strengthening their control over CPRIT.

In October 2012, immediately after Gilman’s resignation, Gov. Rick Perry, House Speaker Joe Straus and Lt. Gov. David Dewhurst sent a letter to CPRIT officials urging them to pursue more commercialization projects.

“CPRIT laid a solid foundation for this endeavor by focusing its efforts and funding predominantly on basic scientific research,” they wrote. “It is now time for CPRIT to take further steps to fulfill its statutory mission and expedite innovation that will deliver new cancer treatments to patients within three to five years.”

Charles Tate, a Houston venture capitalist and member of the oversight committee who engineered the loophole in review of technology incubators, and then worked to have the MD Anderson incubator funded, said CPRIT needed to switch its emphasis to commercialization.

“There’s no question in the minds of the…oversight committee that development/commercialization activities are allowed under the legislation,” Tate said to the Texas Tribune. “The only people who disagree on that are all the people who want all the money spent on research.”

To put Tate’s statement in perspective, Gilman pointed to an earlier statement by the politically active Texas entrepreneur. When the MD Anderson-Rice incubator was first announced, Tate said in a Rice press release that the problem with research is not the absence of scientific breakthroughs but the lack of commercialization expertise.

“One of the biggest obstacles to getting life-saving treatments to patients is not a lack of good ideas or good science, but a lack of business expertise,” he said in a Rice University press release. http:// bit.ly/HyeC0d “CPRIT is proud to support a center that will ensure the best cancer-fighting technologies can make it to market and into the hands of the people who need them the most.”

 

 

Yet, in part due to Gilman’s continuing efforts, events didn’t develop in accordance to the plans Texas politicians may have devised. They solidified their grip on CPRIT, but the place continued to crumble.

First, a routine audit showed that Jerald Cobbs, CPRIT’s chief commercialization officer, had failed to conduct peer review before awarding an $11 million grant to Peloton Therapeutics Inc., a Dallas-based company (The Cancer Letter, Nov. 30, 2012).

Cobbs was a key player in awarding an $18 million grant to a Houston-area biotechnology incubator led by Lynda Chin, scientific director of the MD Anderson Cancer Center Institute for Applied Cancer Science and wife of the center’s president, Ronald DePinho (The Cancer Letter, May 25, 2012).

Gilman flagged the Peloton proposal for CPRIT, but recused himself immediately and was as surprised as anyone else to learn that the proposal wasn’t subjected to formal review by CPRIT. The company didn’t seek special treatment and would likely have passed any review.

Cobbs would later become the only CPRIT official charged and tried in connection with the explosion of widely publicized scandals. He was charged with securing execution of a document by deception, a first-degree felony punishable by imprisonment of five to 99 years and a $10,000 fine.

Gilman believed Cobbs was eager to please his bosses, and while he clearly screwed up by failing to review the Peloton application, this error could be explained: CPRIT was just getting going, and the company’s science was well reviewed by the Column Group, a California-based venture capital firm that had skin in the game. The magnitude of Cobbs’s error didn’t merit a felony charge, and the prospect of becoming a life-long guest of the state government.

Cobbs was ultimately acquitted.

 

 

CPRIT officials were forced to look for Gilman’s successor in the midst of exploding scandals and probes by the legislature and law enforcement authorities.

I was surprised that they wanted to replace Gilman with another reputable scientist.

The job was first offered to Raymond DuBois, who had just left his job as provost at MD Anderson. DuBois had demonstrated both courage and integrity under very difficult circumstances at MD Anderson and there was no reason to expect that he would become anyone’s stooge.

After DuBois said no-thanks, CPRIT recruiters went after Margaret Kripke, DuBois’s predecessor as provost at MD Anderson.

“I read in The Cancer Letter and other news publications about what was going on, and it was very clear that the agency was in danger of losing the money—that the legislature was angry enough about what was happening that they could very well have lost the money,” Kripke said to me recently. “I just got so angry over that issue, because it would have been such a lost opportunity; $2 billion were left at that time. It would have been $2 billion for cancer research wasted at a time when NIH money was so hard to come by. I just thought I shouldn’t sit around and watch that happen.”

Another statistic: CPRIT’s contribution to cancer research in Texas was roughly equal to all NCI funds received by scientists in the state. Moreover, the institute sponsors recruitment and relocation of top-tier cancer scientists to Texas institutions.

Kripke had stepped down as MD Anderson’s provost five years earlier, in 2007, and retired completely in 2009. “I had colleagues who urged me to do it, since I had just retired, I wasn’t really doing much of anything,” she said.

Kripke had another reason to consider taking the job.

“I have thought for a long time that we needed to be spending more of the cancer research portfolio on prevention and early detection, so that was also an opportunity for to try to change the funding a little bit, tweak in the direction of cancer prevention,” she said to me. “Those were really the two factors for me to jump in and throw my hat in the ring for this position.”

Kripke and Gilman weren’t acquainted.

“I called him as soon as I was appointed,” Kripke said. “He was absolutely most gracious. He said he would be willing to help me in any way he could, and to please call him if I needed any advice for anything. He couldn’t have been nicer and more supportive. Which was really terrific. That was a real positive for me because he was of course all of the reviewers were very loyal to Al, and having him be supportive I knew would be very important in terms of helping rebuild the review committee.”

 

 

Just after 11 a.m. on Dec. 11, 2012, CPRIT sent out a press release announcing Kripke’s hiring.

A little more than an hour later, the same office sent out another bit of news: the resignation of Bill Gimson, CPRIT’s executive director, the official ultimately responsible for the MD Anderson and the Peloton fiascos.

In his letter of resignation, Gimson accepted no blame for the events that caused CPRIT to bleed out its scientific credibility and brought it to the edge of a precipice (The Cancer Letter, May 25, 2012, Oct. 12, 2012, Oct. 19, 2012, Oct, 26, 2012).

“The last eight months have been extremely difficult for those at CPRIT—during this time they have not been able to do their jobs due to wasted efforts expended in low value activities that do nothing to advance cures for cancer,” Gimson wrote.

“Unfortunately, I have also been placed in a situation where I feel I can longer be effective. After considerable thought, and in the hope that my fellow CPRIT workers will finally be able to get back to what is important, I hereby tender my resignation as CPRIT Executive Director.”

A couple of hours after this epistle was released to reporters, Kripke took questions at a telephone press conference, arranged by CPRIT officials.

The first question was entirely predictable: what can you say about Gimson resigning?

“Since I learned about it a few minutes ago, I haven’t had an opportunity to digest it yet,” Kripke said. “I am, of course, sorry to hear it, because he seemed to be doing a reasonably good job, and I am waiting to see what the board is going to do about his letter.”

“So, Dr. Kripke, whom are you reporting to?” asked another reporter. “I have no idea at this juncture,” Kripke said. “Until Jan. 17, I am reporting to Mr. Gimson, because he will stay on until then. After that, I don’t know what happens. As you know, I haven’t started yet, so I am in the dark about what’s happening.” Kripke was expected to begin work Jan. 7.

In our recent conversation, Kripke reflected on that day’s strange events.

“I remember you asked me what does that feel like, and I said I have no idea,” Kripke said. “It just happened I haven’t even had time to process this yet. It was quite strange to have the person who had hired me to resign on the day that my appointment was announced.”

Being happily retired, Kripke could look at that day’s events with healthy detachment.

“There was a third issue in my taking the position which was that I really had nothing to lose,” she said. “I figured that if it didn’t work out and the thing collapsed, I didn’t have a gigantic investment in moving to Austin or doing anything like that. For me it wasn’t a major issue, it would work out or it wouldn’t. I would’ve happily gone back to my state of retirement if things did not work out.

“I didn’t know any of the people involved and I wasn’t involved in what was going on in any substantive way. I didn’t have a side to be on—at least that’s how I viewed it.

“I don’t know if it was perceived that way.”

 

 

Kripke initially thought that her top priority would be to get reviewers to return.

At the time, only one of the seven members of the CPRIT Scientific Review Council did not resign.

Richard Kolodner, head of the Ludwig Laboratory of Cancer Genetics and distinguished professor of cellular and molecular medicine at the University of California San Diego, stayed to wait and see how events played out. Gilman supported Kolodner’s strategy.

For one thing, with six of the seven council members gone, there was nothing left to resign from. And if Texas officials decided to restore CPRIT to its former glory, Kolodner’s presence would give the effort credibility.

Meanwhile, CPRIT had additional problems. A moratorium was imposed on making new grants, and there were audits, an inquiry by the legislature as well as civil and criminal investigations. Questions were raised about the structure of CPRIT foundation and the purchasing of furniture for a CPRIT offshoot. The institute was too exposed to remain a target for the “vultures and the hyenas” Gilman spoke about.

 

 

Though more than half of CPRIT’s 100 or so scientific reviewers had departed, Kripke was being precluded from starting recruitment.

“I expected to go right to work rebuilding the committee, but the first thing that happened to us was that the governor imposed a moratorium,” Kripke said. “I couldn’t do anything in terms of recruiting people or rebuilding the review panels, because we were on notice that we might not survive.”

Gimson was replaced by Wayne Roberts, an expert in public finance and budget. His job immediately prior to CPRIT was as associate vice president for public policy at the University of Texas Health Science Center at Houston.

Roberts was a no-nonsense budget guy who spent 18 years at the Legislative Budget Board, served as a deputy and acting budget director for Gov. George W. Bush, and later worked for Gov. Rick Perry in a variety of jobs, including drafting legislation that created the Texas Emerging Technology Fund.

Roberts’s expertise was in workings of state agencies, their budgets and process. It wasn’t limited to health or health administration. By way of comparison, his predecessor, Gimson, had spent 35 years in administrative positions at the Centers for Disease Control and Prevention.

“To some, Wayne seemed an odd choice, as he had no experience in cancer research, patient care or prevention, nor had he ever headed a state agency,” said Tom Kleinworth, vice president for government relations at the Baylor College of Medicine. “What the leadership correctly saw, however, is that to survive the agency would need someone who fully and deeply understood Texas state government. They needed someone who understood state budgeting. They needed someone who understood both the appropriations process and the legislative process. And most of all they needed someone who had a reputation for honesty and integrity.

“That was Wayne.”

Another insider, former Texas Deputy Comptroller Billy Hamilton, was hired as a senior advisor to Roberts and the Oversight Committee. Hamilton at the time was a private consultant. But prior to 2007, he was the chief deputy comptroller of public accounts of Texas.

CPRIT was under orders to stop funding grants, investigations were underway, the blueprints for the state budget didn’t contain any funds for the institute, and the state auditor was preparing what would turn out to be a scathing 99-page report.

Instead of disputing the findings of the state auditor’s report, Roberts decided to implement it in its entirety—all 42 recommendations.

“This in itself was a monumental task, as many of the board members understandably were defensive,” Kleinworth said in an email. “However, he convinced them it was the right thing to do and then, working with the very capable members of the CPRIT staff, quickly and fully implemented the auditor’s recommendations.

He was similarly open to hearing any ideas from legislators. “He convinced them not only that he was open to making any and all changes,” Kleinworth said. “More importantly, he convinced them that CPRIT should continue in existence–that the work it was doing in cancer research, in commercialization and in cancer prevention was and would continue to be beneficial to the people of Texas.”

Two state legislators, Sen. Jane Nelson (R-Flower Mound) and Rep. Jim Keffer (R-Eastland), in effect saved the institute by crafting complex legislation that instituted tighter controls and—just as importantly—got rid of the members of the oversight committee.

Nelson and Keffer had collaborated on the 2007 legislation that created CPRIT. Under the new bill, which saved CPRIT, the staggered terms of existing members ended on the day the new bill went in effect.

Though former members of the Oversight Committee could have been reappointed, they weren’t.

Can Gilman be given credit for the committee’s ouster?

I can say that he never claimed credit in our conversations. However, he did mention speaking with Nelson, Keffer and their staff members, and as a citizen and, of course, scientist he owed them his unvarnished opinion and advice.

I say Al won.

 

 

The auditors’ findings affected Kripke’s work.

“There were a lot of issues that the auditors were unhappy about,” she said. “I don’t think there was anything done maliciously. It was a matter of not dotting all the I’s and crossing all the T’s when they got the agency up and running

“We were not allowed to do anything that looked like we were restarting or returning to business as usual.

“We spent the first year rewriting and implementing all the new rules. It was both pretty difficult and unexpected because that’s not really what I went there for; at least I didn’t think so, but that’s what we did,” Kripke said. “I was in Austin once a week for two to three days a week. For a lot of the time the first year.

“Rewriting the rules meant working out all the details about how appointments were made, the criteria for appointing people to review panels. There were a lot of things that were never really codified, because people were busy trying to get the agency up and running and trying to get grant money flowing. There were a lot of things put in place that were actually never put down on paper. I certainly was involved in the rules regarding the review panels and how the honoraria were paid, and so on.”

Basically, the task amounted to taking the workings of CPRIT and translating them into rules.

Kripke invited Kolodner to become head of the Scientific Review Council.

“He was quite close to Al and spoke with him on a regular basis, so he stayed and because he history with the process, I asked him to be the head of the Scientific Review Council,” Kripke said. “He did discuss that with Al before he accepted.”

Sanjiv “Sam” Gambhir, another member of Gilman’s council, also returned, bringing back his reviewers. Gambhir is the chair of the Department of Radiology at the Stanford University School of Medicine, director of the Canary Center at Stanford for Cancer Early Detection, director of the Molecular Imaging Program at Stanford, and a professor in Stanford’s Department of Radiology, Bio-X Program and the Department of Bioengineering.

Kripke couldn’t have reconstituted the peer review committees without Gilman’s support.

When she invited Tom Curran, to serve as chair of a basic research panel, he checked in with Gilman.

“Al spoke at great length on the phone about how wonderful CPRIT was and strongly encouraged me to accept,” said Curran, chief scientific officer and executive director of the Children’s Mercy Children’s Research Institute. “I am very glad that I did as it has been one of my most enjoyable reviewing experiences (not at all like NIH Study Sections). The committees continue to function according to Al’s design with the primary focus on scientific excellence and impact on cancer. I have not encountered the slightest hint of politics in the decision-making process. CPRIT has helped recruit numerous spectacular scientists to Texas and it continues to fund top quality science. I just wish more states would emulate Texas (which is not something I would normally say).”

Kripke added a review panel on prevention, so that grants in prevention might have an opportunity to get reviewed by people who knew something about prevention.

However, Kripke didn’t think that setting up a threshold of spending on prevention was a good idea. Gilman’s vision of funding the best science—whether prevention or any other area—made sense to her.

Next, Kripke worked on establishing strategic priorities:

“We did it within the peer review system,” she said. “We put out requests for applications in specific areas: childhood cancers, prevention, early detection, computational biology—but we didn’t set aside funds specifically to fund those. They had to compete successfully with the other applications. It’s a matter of trying to emphasize certain areas without disturbing the prioritization based on peer review.

“In truth, there was very little of substance that was changed from what Al did,” Kripke said. “He pretty much got it right the first time around.”

 

Click Here to read The Cancer Letter’s series Slamming the Door: How Al Gilman Taught Texas a Lesson in Cancer Science

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