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CPRIT, Part 7 (Conclusion): Reflections

The story of CPRIT is not over. Revelations and reactions come out almost daily as the power struggles continue. It is ultimately in the legislature's hands what will occur. But the situation is not encouraging. There is no reason to believe that there is a way to put Humpty Dumpty back together again after this fiasco. Nothing I've seen looks at all hopeful about change even though the new CPRIT officials are making compliant noises. The vigorous pro-rapid-commercialization defenses being made are not reassuring. Those who promote a "business" or "engineering" approach to cancer drugs while disdaining scientific evaluation are misguided, but they with probably some sincerity think they are marvelous people who plan to combine "doing good" with "doing well." After all, if Governor Perry had my opinion of the dangers of unproven therapies, he would never have permitted his surgeon to inject him with multiplied stem cells. And, these people are extremely tenacious. The focus seems to be on saying there will be "better management procedures" henceforward and I don't have confidence that will address the impetus to eschew scientific evaluation. There is some hope that some of the earlier monies spent by CPRIT may prove worthwhile, and there is some satisfaction that such a large group of people stood up for the principle that scientific review MUST be a part of deciding what is commercialized. In her resignation letter, Monica Bertagnolli of Harvard Medical School said it best: <blockquote class="tr_bq">In awarding funding, I believe that it is critically important for commercialization potential to be secondary at all times to scientific quality. Many projects that have significant commercialization potential in the short term also lack scientific validity.</blockquote> I would like to shout her last sentence out from the rooftops, or put it on a sign:  Many projects that have significant commercialization potential in the short term also lack scientific validity. When evidence is ignored or suppressed while "products" are put on the market, people are bilked, money is wasted, and very often people are physically harmed as well (cf. Ben Goldacre's sensible reflections on <a href="http://www.nytimes.com/2013/02/02/opinion/health-cares-trick-coin.html" target="_blank">Health Care's Trick Coin</a>). The more commercialization without evidence becomes the norm, the more people are injured by bad medicine. Of course, there is another way to look at this. Money out of one person's pocket is indeed money into another person's, and, as Governor Perry astutely observes, this makes for a lot of "wealth creation." (And as he also astutely observes, basic research doesn't always do that.) If we want to make some people very wealthy and our medical system even more ahead of the rest of the world in being most costly -- hey, way to go! If we want to turn a supposed cancer research endeavor into yet another of the Governor's taxpayer-funded slush funds for campaign contributors -- great work!

CPRIT, Part 7 (Conclusion): Reflections

The story of CPRIT is not over. Revelations and reactions come out almost daily as the power struggles continue. It is ultimately in the leg...

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The Story of CPRIT, Part 6: Reactions

There has been a lot of dismay in Texas as all this has become public (with the word "cronyism" being mentioned very frequently). As the Houston Chronicle asked in May: <blockquote class="tr_bq">Why is CPRIT even funding commercial enterprises? Didn't voters expect the bond money to support research?</blockquote>[Answer: Voters did, and there was no mention of commercialization in the ballot measure. Legislators did get language about commercialization into the enabling legislation, however.] Newspapers and bloggers have not been happy with what is going on. Nor have some former supporters. Cathy Bonner, a cancer survivor and activist who had worked hard to get the agency established, said succinctly:  <blockquote class="tr_bq">The vision was to make Texas the center for curing cancer. It wasn't to make Texas the center for capitalizing on cancer.</blockquote> But those in power show few signs of giving ground. After the resignations in October, a joint letter from the governor, lieutenant governor and speaker of the House urged more commercialization: <blockquote class="tr_bq">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.</blockquote> In an October appearance at CPRIT, Perry stated: <blockquote class="tr_bq">Since CPRIT's creation, you all have helped lay a sound foundation to establish one of the greatest cancer-fighting tools in human history. The challenge that remains before us is to build on that foundation and finally begin curing cancer once and for all. </blockquote>As The Cancer Letter <a href="http://www.cancerletter.com/articles/20121026_1" target="_blank">tartly observed</a> : <blockquote class="tr_bq">This statement could mean either that (a) Perry doesn’t realize that his claim that Texas has done all the basic science required to proceed to cranking out cancer cures would not gain wide traction among scientists and clinicians, or (b) CPRIT has become precisely what the governor and others in Texas politics want it to be: a pot of public money that can be dispensed for commercial or political purposes. <div></div></blockquote><div>Interviewed by the Houston Chronicle in January, Perry <a href="http://eyeonwilliamson.org/?p=12092" target="_blank">continued in the same vein</a>: </div><blockquote class="tr_bq"><div>The way that the Legislature intended it was to get cures into the public's area as soon as possible and at the same time create economic avenues (from) which wealth can be created. Basic research takes a long time and may or may not ever create wealth.</div></blockquote>Matt Winkler, a member of CPRIT's Scientific and Prevention Advisory Council, last week <a href="http://www.statesman.com/news/business/winkler-commercialization-is-the-key-to-new-cancer/nT5GT/" target="_blank">expressed his opinion to the Austin Statesman</a> that the criticism of commercialization -- Winkler prefers the term "product development" -- was totally on the wrong track. "Continuing to short-change commercialization, Winkler said, comes at the expense of patients because money for basic research is unlikely to benefit patients during the 10-year lifetime of CPRIT. Winkler says lawmakers should insist on more investment in commercialization companies, not less." According to Winkler: <blockquote class="tr_bq">Much of the essential basic research that has given us our fundamental understanding of cancer has been done. The challenge now is to fill in the details and to move this knowledge into the clinic.</blockquote> Disagreeing strongly with these ways of thinking,Walt Goodpastor, who lost a son to cancer, <a href="http://www.chron.com/opinion/outlook/article/CPRIT-belongs-to-the-people-of-Texas-4211814.php" target="_blank">angrily wrote</a>:  <blockquote class="tr_bq">I don't know where Perry studied economics. But CPRIT's wealth has already been created. It was created by the productive citizens of Texas. What Perry wants to do is transfer that wealth into the pockets of private corporations.</blockquote><blockquote class="tr_bq">I do not believe the industry is particularly interested in finding true cures. Its business model is based on treating cancer. As in prevention, there is little profit to be made in a cure. Treating cancer provides an ongoing stream of revenue. Curing or preventing cancer would end that revenue stream. </blockquote><blockquote class="tr_bq">I believe that the most bang for our buck would come from awarding grants to independent individual scientists who are working on promising leads.</blockquote> And the Houston Chronicle <a href="http://www.chron.com/opinion/editorials/article/Mission-creep-4196805.php" target="_blank">edito</a><a href="http://www.chron.com/opinion/editorials/article/Mission-creep-4196805.php" target="_blank">rialized on January 15</a>: <blockquote class="tr_bq">To get the most cancer-fighting bang for its bucks, CPRIT ought to focus on important research that private companies won't do: the slow, might-not-pay-off basic research that sometimes yields enormous breakthroughs; and research on cheap therapies and prevention measures - stuff that, even if it works beautifully against cancer, won't yield a patentable, profitable drug.</blockquote><blockquote class="tr_bq">     If there's a high probability that a given line of research will create wealth in a short amount of time, you can bet that a pharmaceutical company will bankroll that project on its own - no government help needed.</blockquote> Nobel laureates Gilman and Sharp, who had led the walkout, wrote <a href="http://www.cancerletter.com/articles/20121019_1" target="_blank">their own editorial</a>, which says in part:  <blockquote class="tr_bq">Texans deserve to hear the truth about cancer. They must understand that miracles will not happen in a short time. Progress will not be made by those who simply proclaim without explanation that they can do better than hundreds of skillfully staffed and well-financed pharmaceutical and biotechnology companies. . .</blockquote><div></div><blockquote class="tr_bq"><div>Reliance on peer review to identify the best science must continue to guide CPRIT in the future. Of course, there are other ways to distribute public funds, but they are worse.  </div></blockquote>

The Story of CPRIT, Part 6: Reactions

There has been a lot of dismay in Texas as all this has become public (with the word "cronyism" being mentioned very frequently). ...

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The Story of CPRIT, Part 5: A Can of Worms

The publicity engendered by the walkout caused more attention to various aspects of the Cancer Prevention & Research Institute of Texas (CPRIT). This turned up a number of other real or potential issues, as a compliance officer reviewed all past commercialization grants and a state audit was done. (As well, investigations by the Travis County DA and the Attorney General of Texas are ongoing.) The Dallas Morning News discovered that commercialization awards had been going to companies with connections to Perry and Dewhurst campaign contributors. A CPRIT commercialization award had gone to a firm, Caliber Biotherapeutics, associated with a Dallas businessman who made substantial contributions to the campaigns of Governor Perry and Lieutenant Governor Dewhurst. When the paper probed about what sort of review scores the commercialization awards had received, it was discovered that one commercialization award, $11 million to Peloton Therapeutics in 2010, had been made with no formal review or scoring of any kind. It was simply placed on the Oversight Committee's agenda by Jerry Cobb, the Chief Commercialization Officer, and approved. Philanthropist Peter O'Donnell, an investor in Peloton, had contributed around a couple of hundred thousand dollars each to Governor Perry and to David Dewhurst. As well, his O'Donnell Foundation had contributed $1.6 million to the CPRIT Foundation. (However, it <a href="http://www.cancerletter.com/articles/20121217" target="_blank">may have been</a> that O’Donnell bought the Peloton stock after the company was funded, and had transferred the stock to UT Southwestern.) Jerry Cobb, the Chief Commercialization Officer, resigned in November. Bill Gimson resigned as executive director of CPRIT in December. And a freeze, requested by political officials, was placed on new grants in December.   Questions <a href="http://www.texastribune.org/2012/12/14/secretive-cancer-foundation-pays-consultants-well/">were raised about the CPRIT Foundation</a>, which raised private money for CPRIT for various purposes including $609,000 used for supplementation of salaries of CPRIT's top officials, including Dr. Gilman. The Foundation maintained it had no obligation to disclose donors or file tax returns, but after pressure, <a href="http://www.texastribune.org/2013/01/10/cprit-foundation-releases-list-donors/">names of donors were revealed</a>. These included donations from pharmaceutical and drug development companies, and from people associated with companies that had received CPRIT awards. And a state audit <a href="https://www.texastribune.org/2013/01/28/state-audit-exposes-problems-cancer-institute/" target="_blank">came out in late Jan</a><a href="https://www.texastribune.org/2013/01/28/state-audit-exposes-problems-cancer-institute/" target="_blank">uary</a>, raising still further questions. The state audit was very critical of  a number of things, including a third grant that had been approved without proper review, for $25.2 million, to CTNeT (Statewide Clinical Trials Network of Texas, "a non-profit company whose purpose is to develop an efficient cancer clinical trial network for evaluating therapeutic drugs and treatments for cancer in adults and children"). The award was made before the company was formed to M.D. Anderson, and then the money was transferred to CPRIT once the company was established. The executive director of the O'Donnell Foundation, mentioned above, was the registered agent for CTNeT rather than anyone from M.D. Anderson. Also, constitutional requirements about matching funds were not being complied with, and funds were dispersed for purposes not appropriate for a research grant.

The Story of CPRIT, Part 5: A Can of Worms

The publicity engendered by the walkout caused more attention to various aspects of the Cancer Prevention & Research Institute of Texas ...

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American Medical News: Dangers of "EHR Sloppy and Paste"

An American Medical News (<a href="http://amednews.com/" target="_blank">amednews.com</a>) article by Kevin O'Reilly appeared entitled "EHRs: 'Sloppy and paste' endures despite patient safety risk." It addresses the dangers of a common feature of EHR's used recklessly:  copy-and-paste. <blockquote class="tr_bq"><a href="http://www.ama-assn.org/amednews/2013/02/04/prl20204.htm" target="_blank">EHRs: “Sloppy and paste” endures despite patient safety risk</a> Copying and pasting information is common within EHRs, but the practice sometimes can lead to confusion and endanger patient care. <div id="Byline"> </div><div id="Byline">By <a href="http://www.ama-assn.org/amednews/site/bio.htm#o%27reilly">Kevin B. O'Reilly</a>, amednews staff. Posted Feb. 4, 2013.</div><div id="Byline"> </div><div id="Btext1">During the winter holidays, a patient at Yale-New Haven Hospital in Connecticut had a large pressure ulcer with an abscess. A surgical intern made a note in the patient’s electronic health record that said, “Patient needs drainage, may need OR.”</div><div id="Btext1"> </div>The problem? The same note appeared for several consecutive days, even after a surgical team successfully drained the abscess. The intern had copied and pasted the previous day’s note, but failed to appropriately update it to reflect the fact that the drainage was done. The note confused the consulting infectious disease team and nearly led to an unneeded change in the patient’s antibiotic regimen.</blockquote><div id="Byline"> </div><div id="Byline">That's somewhat ironic.  I performed my postdoc at Yale Center for Medical Informatics where we discussed, among other issues, potential drawbacks of badly-designed or implemented EHRs.   Unfortunately, I hear from people who've left that the Center is relatively marginalized these days with respect to influence.  (Actually, the marginalization goes way back; if they'd listened to us in the mid 1990's they might have avoided <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Insufficient%20IT%20management" target="_blank">this multimillion-dollar federal lawsuit for billing fraud</a>.)</div><div id="Byline"> </div><div id="Byline">Mr. O'Reilly continues:</div><div id="Byline"> </div><blockquote class="tr_bq">The practice of carelessly copying and pasting previous information, often dubbed “sloppy and paste,” is on the decline at Yale-New Haven Hospital but is widespread across medicine and can lead to mix-ups that sometimes harm patients, research shows. “It’s especially problematic when you have multiple teams taking care of the patient and we’re communicating through the chart, which happens very often nowadays because physicians don’t see each other as often as we used to,” said Dr. Horwitz [General internist Leora Horwitz, MD], assistant professor of medicine at Yale University School of Medicine. “We do rely on the chart in many cases, and it can lead to genuine confusion.”</blockquote> When you rely on an information system and the information system contains incorrect information (for whatever reason), patients are put at risk.  That the systems are implemented without simple controls on copy-and-paste (such as permanently embedding substantive metadata in the output) is a significant flaw. From Sec. II of Aguilar v. Immigration and Customs Enforcement Div. of U.S. Dept. of Homeland Sec. 2008 WL 5062700 (S.D.N.Y. Nov. 21, 2008), available at <a href="http://jeffparmet.com/pdf/aguilar-v-immigration.pdf" target="_blank">this link</a>:  <blockquote class="tr_bq">... Substantive metadata, also known as application metadata, is “created as a function of the application software used to create the document or file” and reflects substantive changes made by the user. Sedona Principles 2d Cmt. 12a; Md. Protocol 26. This category of metadata reflects modifications to a document, such as prior edits or editorial comments, and includes data that instructs the computer how to display the fonts and spacing in a document. Sedona Principles 2d Cmt. 12a. Substantive metadata is embedded in the document it describes and remains with the document when it is moved or copied. Id</blockquote> Microsoft Word's "Track Changes" feature is an example of substantive metadata being displayed. The available stats on the phenomenon are of great concern: <blockquote class="tr_bq">... A study in February’s Critical Care Medicine found that copying and pasting is the rule in EHRs rather than the exception. Using a software program that can detect identical matching word sequences, researchers examined the assessment-and-plan portions of more than 2,000 progress notes for 135 patients created by 62 residents and 11 attending physicians working in a Cleveland medical intensive care unit. For the residents, 82% of the notes contained 20% or more copied text, while 74% of attending doctors’ notes also exceeded that rate of copying and pasting. A similar study in the January-February 2010 issue of Journal of the American Medical Informatics Assn. found a copy-and-paste rate of 78% in sign-out notes generated by internal medicine residents. The rate of copied text in progress notes was 54%, the study said.</blockquote> <div id="Byline">An example of physician embarrassment at relaying quite outdated information to a patient's family due to repeated note-copying was cited, and then a case of actual harm:</div><div id="Byline"> </div><blockquote class="tr_bq">... Other times, patients are harmed. In a July/August 2007 case study in AHRQ WebM&M, an online patient safety journal, William Hersh, MD, described the case of a 77-year-old woman hospitalized for diarrhea and dehydration after chemotherapy. An intern noted that the patient would receive heparin to prevent venous thromboembolism. The note was copied and pasted for four days in a row and signed by a resident and an attending physician, who appeared to believe the heparin had been ordered and administered. Ultimately, the patient was discharged without ever receiving the preventive medicine and two days later was rehospitalized and diagnosed with a pulmonary embolism. Only then did physicians realize the patient never got the correct prophylaxis. “The problem is getting worse now with the rise of EHRs,” said Dr. Hersh, professor and chair of the Dept. of Medical Informatics and Clinical Epidemiology at Oregon Health & Science University in Portland.</blockquote><div id="Byline"> </div><div>The American Medical News article continues:</div><div></div> <blockquote class="tr_bq"><div>HHS OIG (Office of the Inspector General) announced that it plans to review multiple EHR notes for the same patient by the same physician to see whether doctors are copying and pasting the identical note from visit to visit. The practice is sometimes called cloning and could be implicated in fraudulent coding and billing practices. </div></blockquote><div> </div><div>That might serve to partially stem the process, but the HHS OIG's resources are not infinite.</div><div> </div><div>The article concludes:</div><div> </div><blockquote class="tr_bq"><div>John Halamka, MD, calls for a more radical fix. “The way we document in medicine has grown up over decades for medical reasons, for billing, for medical-legal justification,” said Dr. Halamka, chief information officer at Beth Israel Deaconess Medical Center in Boston. “You wind up with 17 pages of replicated and duplicated and challenging-to-read documentation. I propose we blow up the way we do documentation altogether and replace it with a Wikipedia-like structure.” Such an approach would allow physicians to edit the progress note collaboratively, just as the popular open-source encyclopedia is updated. Dr. Halamka hopes to pilot-test the idea within the next year. “With that concept, you wouldn’t ever really need to copy and paste,” he said.</div></blockquote><div></div><div> An interesting concept and experiment.  My questions:</div><div> </div><div><ul><li>Do we first rigorously investigate and understand the causes of the copying, i.e., cryptic and difficult-to-use data entry methods that significantly slow clinicians down?   </li></ul><ul><li>Do we get informed consent from patients for the experiment? </li></ul><ul><li>If so, what do we tell them?  We are conducting an experiment in charting, risk unknown, to solve cheating and risks due to poorly-designed EMRs? </li></ul><ul><li>Would not simpler solutions (such as the embedded-metadata identifiers indicating text has been copied as I described above)  be important to implement first, before experimenting with medical documentation? </li></ul></div><div> </div><div>That said, I believe the practice - an unintended and potentially adverse side effect of a new information technology, HIT - must stop.  I think Mr. O'Reilly makes that point clear.  Read his article at the link above.</div><div> </div><div>-- SS</div><div></div>

American Medical News: Dangers of "EHR Sloppy and Paste"

An American Medical News ( amednews.com ) article by Kevin O'Reilly appeared entitled "EHRs: 'Sloppy and paste' endures des...

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The Story of CPRIT Continued, Part 4: The Walkout

Gilman’s resignation, though tendered in May, was effective in October. He wanted to shepherd grants that had already been through peer review but which were not yet actually funded through funding if possible, particularly as they had been delayed in the spring at the same time as the IACS grant was approved. He asked his peer reviewers to hang in with him through October. It is clear that he really tried his hardest to get a change in the new revised course of CPRIT – but he lost, and completely. He tried to get agreement that future commercialization projects would be subject to scientific review – and he got absolutely nowhere on this. He did succeed in getting delayed grants seen through the funding process; and then, in October, he left – and so did most of the peer review panelists he had assembled. Seven of eight scientific review council members resigned, and so did probably around 70 of the approximately 100 out-of-state cancer researchers and clinicians who comprised the peer review panels. Some of the <a href="https://www.documentcloud.org/documents/469784-cprit-resignation-letters.html" target="_blank">resignation letters</a> make interesting reading. Scott Kern of Johns Hopkins said he had had an eerily similar experience in the past: <blockquote class="tr_bq">It is ironic that I again find myself in the undesirable position of resigning from a hard-working and highest-quality scientific study section. . . . Ten years ago. I served on the scienfific review board of a private philanthropic organization. In an unusual development, I was asked to review two special grant applications that had arrived out-of-cycle. After my review I was informed by the organiztion that they had beforehand decided to fund the two grants, a decision made prior to obtaining the reviews from the scientific board. They had in this instance perhaps operated as a direct money conduit and not as a peer review-guided granting operation. Owing to the deprecated role of scientific review under such procedures, I regretfully resigned from their board. . . . I now find that a somewhat similar situation exists at CPRIT. </blockquote><blockquote class="tr_bq">The irony is as follows. The PI of a grant receiving questionable dispensation ten years ago, and a PI of a grant recently under critical scrutiny for improper dispensation at CPRIT, were the identical person.</blockquote> Bryan Dylnacht, NYU School of Medicine, wrote: <blockquote class="tr_bq">You may find that it was not worth subverting the entire scientific enterprise – and my understanding was that the intended goal of CPRIT was to fund the best cancer research in Texas – on account of this ostensibly new, politically-driven, commercialization-based mission. . .[S]uch a policy – wherein science that has been judged meritorious by a highly esteemed group of scientists is discounted at the expense of science that has not been methodically reviewed – . . . will in fact succumb to mediocrity.</blockquote> William Kaelin of Harvard noted that <blockquote class="tr_bq">Trying to commercialize flawed science is a prescription for failure and waste.</blockquote> William C Hahn of Dana-Farber/Harvard Cancer Center wrote that:: <blockquote class="tr_bq">I am troubled by the Oversight Committee’s recent request that those of us that participated in the scientific review of commercialization applications reconsider our scoring in the absence of any additional substantive information or progress by the applicants to strengthen what were wholly naïve and underdeveloped applications. These actions make it clear that the CPRIT Oversight Committee has elected to disregard scientific review to pursue a different agenda.</blockquote> John Petrini of Memorial Sloan-Kettering Cancer Center stated that <blockquote class="tr_bq">CPRIT leadership has begun to assert an agenda in which commercialization and salesmanship are rewarded and scientific quality devalued. This is a disservice to the people of your state that will inhibit the prosecution of fruitful scientific endeavors focused on cancer.</blockquote>  The Cancer Letter <a href="http://cancerletter.live.subhub.com/articles/20121015_1" target="_blank">summed it up</a>: <blockquote class="tr_bq"><div>The scientific review council members are being followed by the vast majority of rank-and-file reviewers, . . . all from outside Texas. . . .</div></blockquote><blockquote class="tr_bq"><div> MD Anderson officials withdrew the incubator grant, pledging to resubmit it for review later. Yet, scientists are leaving because they have no confidence in a post-Gilman CPRIT. </div></blockquote><blockquote class="tr_bq"><div>This walkout is an extraordinary act of solidarity on a scale never before observed in cancer science in the U.S. Even when former NCI director Andrew von Eschenbach was making patently absurd statements about eliminating suffering and death due to cancer by the year 2015, he encountered no open opposition from scientists. </div></blockquote><blockquote class="tr_bq"><div>     The walkout—and, perhaps more so, the letters—send a powerful signal that CPRIT is now outside mainstream cancer science. </div></blockquote> <blockquote class="tr_bq"><div></div></blockquote>

The Story of CPRIT Continued, Part 4: The Walkout

Gilman’s resignation, though tendered in May, was effective in October. He wanted to shepherd grants that had already been through peer revi...

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Not the Story of CPRIT - Part 3: A Tangentially-Related Detour

I take a brief hiatus from relating the story of CPRIT to tell another story. This one is about a company that – please note – has no connection to CPRIT: Celltex Therapeutics. The tangential connection is that they are both in Texas and both are related to the mindset of some business folk and of our governor, Rick Perry, the man who recently stated that <blockquote class="tr_bq">[CPRIT was] . . . intended . . . to get cures into the public's arena as soon as possible and at the same time create economic avenues (from) which wealth can be created. Basic research takes a long time and may or may not ever create wealth.</blockquote>A <a href="http://www.businessweek.com/articles/2013-01-03/stem-cell-showdown-celltex-vs-dot-the-fda" target="_blank">recent and excellent article in Bloomberg Businessweek</a> discusses the Houston company and its founders, investor/businessman David Eller and orthopedic surgeon Stanley Jones, one of whose patients is Governor Perry. Celltex reached agreement with a South Korean company active in stem cell production and for a while, <a href="http://thecaucus.blogs.nytimes.com/2011/08/04/rick-perry-has-stem-cell-procedure-then-works-to-bring-it-to-texas/" target="_blank">with the permission of the Texas Medical Board</a>, charged a number of people large sums of money for treatment with stem cells produced in a lab from adult stem cells earlier removed from their bodies. These treatments were supposedly part of a clinical trial, but one without a placebo arm. Governor Perry <a href="http://www.texastribune.org/2011/08/03/perrys-surgery-included-experimental-stem-cell-the/" target="_blank">himself received the treatment after his back operation</a>, done by Dr. Jones, in summer 2011. A leader of the South Korean company stated: <blockquote class="tr_bq">The reason we started in this way is that adult stem cells are not considered a drug in Texas. We had the expectation that treatment in Texas was possible without FDA approval. </blockquote>However, Celltex ran into objections from the FDA to this. The FDA holds that the cultured and expanded cells are indeed a drug. As well, the FDA has had objections to the way both the IRB (for the clinical trial Celltex was supposed to be conducting) and the lab (to produce the cells) were operating. Last fall, treatment shut down for now. Governor Perry strongly disagrees with this shutdown: <blockquote class="tr_bq">Hopefully, the FDA will realize that what’s going on in Texas is good medicine and good economics.</blockquote>Although this intermission is not technically related to CPRIT, I think it is nonetheless illuminating. We need to understand the mental model of people who want to rush stuff to patients. In this mental model, companies like Celltex are wonderful, inspiring examples. Like it or not, this is the brave new world of rapid commercialization Perry visualizes and advocates – and understanding that vision does have relevance to the CPRIT controversies.

Not the Story of CPRIT - Part 3: A Tangentially-Related Detour

I take a brief hiatus from relating the story of CPRIT to tell another story. This one is about a company that – please note – has no conne...

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The Story of CPRIT, Part 2: A Problematic Grant

The grant that upset Dr. Gilman so much that he chose to resign was an award of $22 million dollars for one year. The award had been presented to the Oversight Committeee and approved without going through any scientific review. It was a combination award to Rice and to an organization, <a href="http://www.mdanderson.org/education-and-research/departments-programs-and-labs/programs-centers-institutes/institute-for-applied-cancer-science/index.html" target="_blank">IACS (Institute for Applied Cancer Science)</a>, associated with Lynda Chin, a scientist and wife of the president of M.D. Anderson, Ronald DePinho. Remarkably, the IACS portion of the award had not been reviewed by the provost of either Rice or M.D. Anderson, and after reaching CPRIT, it was rushed through the CPRIT approval process in a very short timeframe in March 2012, and <a href="http://www.chron.com/news/houston-texas/article/Anatomy-of-a-grant-Emails-indicate-cancer-agency-3622443.php" target="_blank">not at all in the regular way</a> of electronic submission and a review process mentioned in yesterday’s post. Apparently, this had been in the works for some time. CPRIT memos show discussion of this between Jerry Cobbs, the Chief Commercialization Officer, and the IACS people as early as January. And Charles Sherr, a member of the Scientific Review Council, <a href="http://www.chron.com/news/houston-texas/article/UT-system-clears-M-D-Anderson-but-questions-3635748.php" target="_blank">recounted in a May email</a> that he had run into DePinho in October at the annual meeting of the American Academy of Arts & Sciences. <blockquote class="tr_bq">Over cocktails, I ran into Ron who immediately told me that he was in direct touch with ‘the higher-ups’ who run CPRIT and that the program and Al would soon be under pressure to change the current approach. . . . [I suggested] he might speak directly to Al. Well appreciating Ron’s malignant ambition . . . , I was not blind-sided later by the proposal to mount ‘a Lynda Chin Institute’ under the auspices of Ron and MDACC. It is  my firm belief that Ron has played a direct and important role in helping to orchestrate what is, in effect, a coup d’etat.</blockquote> Dr. Gilman, on the other hand, was very much blindsided. <blockquote class="tr_bq">A week before the Oversight Committee meeting, I learned essentially by accident that CPRIT was to make an $18M aware to Lynda Chin to fund the Institute for Applied Cancer Science. The proposal on which this was based was less than 7 pages, was submitted via the back door on March 11, and was presented to the Oversight Committee for funding less than two weeks later.</blockquote> When he discovered it, he was extremely angry.  Bill Gimson, the executive director of CPRIT, wrote to a member of the Oversight Committee: <blockquote class="tr_bq">Al is very, very upset that the Lynda Chin operation at MD Anderson is coming in as an incubator – he feels that she did that to avoid the research peer review and that it is <a href="http://www.texastribune.org/2011/11/28/cancer-research-institute-coming-houston/" target="_blank">not an incubator because it is research</a>.</blockquote> Earlier, Dr. Gilman had bought off on approving a $4 million grant for an incubator sponsored by Rice University, one pushed heavily by Charles Tate, a venture capitalist and commercialization advocate appointed to CPRIT’s Oversight Committee by Dewhurst (Tate had made campaign contributions amounting to hundreds of thousands of dollars to Dewhurst). The incubator was to be allowed to chose promising projects without the usual scientific oversight. (My personal thought is that this was possibly a tactical error on Gilman's part that he agreed to it, as this project was designed to be the "foot in the door" for enabling many future projects to evade the regular process of scientific review, judging by the fact that it was later described by a proponent as a commitment "to run a separate line aimed at commercialization that did not rest on scientific review.") Now, the IACS’s short proposal was joined with the Rice incubator project and the grant amount vastly increased under the rubric of describing the whole thing as appropriate for an “incubator.” As Gilman angrily wrote: <blockquote class="tr_bq">An award of $18 million for a research proposal without a research review – based on the administrative act of bolting it to an incubator proposal and the claim that this is an appropriate award for an incubator – is amazingly transparent. Deny it all you want, everyone who has looked at the proposal realizes that it is a joke. Everyone will also wonder why they cannot submit a seven page general description of a modus operandi, free of detail, and receive a multi-million dollar award if they simply say, ‘I hope to commercialize something, sometime.’</blockquote> In addition, plans going forward by those who wanted to remold CPRIT were for commercialization projects to take around half of remaining monies after administration costs and a statutorily-designated 10% for cancer prevention research and activities. This was very different from what had occurred up to that point. The bulk of over the $700 million already awarded had gone to research. Matt Winkler, a member of CPRIT’s Scientific and Prevention Advisory Council, stated blandly: <blockquote class="tr_bq">We should really get out of the business of copying what the NIH does.</blockquote>Joined with the idea that many “translational” projects should NOT be subject to scientific review, this was too much for Dr. Gilman – and ultimately for many others – to swallow. Not science but business was the new order of the day at CPRIT, as its leaders made clear when the news of Dr. Gilman’s resignation was leaked to the press. Bill Gimson, the CPRIT Executive Director, defended CPRIT's increased emphasis on commercialization, stating in June: <blockquote class="tr_bq">We're going to reinvent ourselves on a regular basis.</blockquote>As to the celerity with which the grant was approved, he said: <blockquote class="tr_bq">We did indeed move quickly with the review of the collaboration between Rice and MD Anderson, just as we have fast tracked other very exciting and potentially lifesaving commercial ventures and research recruitment awards – which can be approved in as little as a couple of weeks. </blockquote> <a href="http://news.sciencemag.org/scienceinsider/2012/05/more-controversy-over-20-million.html" target="_blank">Dr. DePinho wrote the Houston Chronicle</a> to contend that:  <blockquote class="tr_bq">ACS is a game-changer - not a traditional research undertaking - that provides a robust pipeline for successful drug development. ... Because it is not a research project, no in-depth science was included. ... With its industry-seasoned professional staff numbering 56, the IACS conducts rigorous, goal-oriented, milestone-driven activities …Some may choose to call our proposal ‘research.’ We call it business, and we are confident Texans will be the beneficiaries. ... The current output of the IACS pipeline will prove its commercial impact in the near future. </blockquote>

The Story of CPRIT, Part 2: A Problematic Grant

The grant that upset Dr. Gilman so much that he chose to resign was an award of $22 million dollars for one year. The award had been present...

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