healthy4u: CPRIT

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 1: A Promising Start

HC Renewal readers who don’t live in Texas may not have followed the saga of the Cancer Prevention & Research Institute of Texas (CPRIT). It’s a fascinating story which will take me more than one post to tell even a partial version of, especially since a wealth of information is available because of FOIA requests and the superb reporting of the Houston Chronicle and The Cancer Letter. A <a href="http://www.statutes.legis.state.tx.us/Docs/CN/htm/CN.3.htm#3.67" target="_blank">constitutional amendment authorizing CPRIT</a> was proposed to the voters in November 2007. (In Texas, lots of things that could be passed legislatively elsewhere require amending the constitution, so that it’s now a very long document indeed.) With a pot of money second only to the NIH’s (up to $300 million in bonds per year was authorized for 10 years for a total of $3 billion), its ambitious goal was to make progress against cancer while making Texas a real leader in cancer research. Enabling legislation was passed and the institute got off to a good start in 2009 by putting together a leadership team that included Nobel prize winner Alfred Gilman as Chief Scientific Officer and Phillip Sharp (another Nobel prize winner) as head of its Scientific Review Council. The <a href="http://www.cprit.state.tx.us/news/nobel-laureate-phillip-a-sharp-phd-to-head-cprit-scientific-review-council/" target="_blank">press release announcing Sharp’s appointment</a> stated: <blockquote class="tr_bq">Research and prevention grant applications will be assessed using an external- to-Texas peer review process. . . . [P]olicies and processes [are being formalized] that will ensure CPRIT funds only the best scientific research and prevention projects, measures its success and shares results on progress so that Texas will lead the nation as a model for cancer research and prevention programs.</blockquote> The process was formalized; and the 2009 Policies and Procedures Guide has a diagram showing that grants were supposed to be submitted electronically, be triaged for merit, and (if they survived initial triage) first go through scientific peer review, then go through commercialization review for business worthiness (only if they were translational projects), be recommended for funding, and then be submitted for review and final funding approval by the CPRIT Oversight Committee (cf. <a href="http://s3.amazonaws.com/static.texastribune.org/media/documents/13-018.pdf" target="_blank">State Audit report</a>, Appendix 5). Peer review teams of eminent out-of-state scientists were put together, the process got going, and projects deemed worthy by the Scientific Review Council were routinely approved by <a href="http://www.cprit.state.tx.us/about-cprit/governingboard/" target="_blank">CPRIT’s Oversight Committee</a>, a group of political appointees plus the Attorney General and the State Comptroller. CPRIT money <a href="http://www.dallasnews.com/business/columnists/mitchell-schnurman/20121020-mitchell-schnurman-why-texas-growth-still-draws-high-achievers.ece" target="_blank">helped attract some eminent researchers to the state</a>.  But then, it all fell apart. Dr. Gilman, the Nobel laureate who had set up the scientific review process, submitted a letter of resignation in May 2012, effective the following October. In his resignation letter, he stated that he would like “to prevent further award of vast funds for research programs ostensibly within incubators that were not described and therefore could not have been reviewed.” The grant that he refers to and that had upset him so mightily was a large one-year combined award approved in March for an incubator at Rice University and for MD Anderson’s Institute for Applied Cancer Science.   Why was he so upset about this particular award? More on that in the next installment.

The Story of CPRIT, Part 1: A Promising Start

HC Renewal readers who don’t live in Texas may not have followed the saga of the Cancer Prevention & Research Institute of Texas (CPRIT)...

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