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

<span style="font-family: inherit;">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.)</span><br /><span style="font-family: inherit;"><br /></span><span style="font-family: inherit;">The <i>Dallas Morning News</i> 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. </span><br /><span style="font-family: inherit;"><br /></span><span style="font-family: inherit;">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 <i>no formal review or scoring of any kind</i>. It was simply placed on the Oversight Committee's agenda by Jerry Cobb, the Chief Commercialization Officer, and approved. P<span style="font-size: small;">hilanth<span style="font-size: small;">ropist P</span></span>eter 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<span style="font-size: small;"> to the</span> CPRIT Foundation. (However, it <a href="http://www.cancerletter.com/articles/20121217" target="_blank">may have been</a> that <span style="font-size: small;">O’Donnell bought the Peloton stock <i>a</i><span style="font-size: small;"><i>fter</i> the company was funded, and ha<span style="font-size: small;">d transferred the stock</span></span></span><span style="font-size: small;"><span style="font-size: small;"> </span>to UT Southwestern.<span style="font-size: small;">)</span></span></span><br /><span style="font-family: inherit;"><br /></span><span style="font-family: inherit;">Jerry Cobb, the Chief Commercialization Officer, resigned in November. Bill Gimson resigned as executive director of CPRIT in December.<span style="font-size: small;"> <span style="font-size: small;">And <span style="font-size: small;">a freeze, requested by political officials, was placed on new grants in December. <span style="font-size: small;"> </span></span></span></span></span><br /><br /><span style="font-family: inherit;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;">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 <span style="font-size: small;">for </span>CPRIT for various purposes including </span></span></span></span></span><span style="font-family: inherit;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;">$609,000 <span style="font-size: small;">used for </span>supplementation of salaries of CPRIT's<span style="font-size: small;"> top officials, including Dr. Gilman. The Foundation maintained it had no obligation to disclose donors<span style="font-size: small;"> or file tax returns</span></span>, <span style="font-size: small;">but</span> 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.</span></span></span></span></span><br /><br /><span style="font-family: inherit;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;"><span style="font-size: small;">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><span style="font-size: small;"><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 <span style="font-size: small;"><span style="font-size: small;"> a <span style="font-size: small;">number of things, including a </span>third grant that had been approved <span style="font-size: small;">without proper review, <span style="font-size: small;">for $25.2 million, </span>to CTN<span style="font-size: small;">e</span>T (Statewide Clinical Tr<span style="font-size: small;">ials Network of Texas, <span style="font-size: small;">"a non<span style="font-size: small;">-profit company whose purpose is to develop an efficient cancer clinical trial net<span style="font-size: small;">work for evaluating therapeutic drugs and treatments for cancer in adults and children"<span style="font-size: small;">).</span> 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'<span style="font-size: small;">Donnell <span style="font-size: small;">F</span>oundation, mentioned above, was the registered agent for </span></span></span></span></span></span></span></span></span></span></span></span></span></span>CTNeT rather than anyone from M.D. Anderson.<span style="font-size: small;"> </span>A<span style="font-size: small;">lso</span>, <span style="font-size: small;">constitutional requirements about matching funds were not being complied with, and funds were dispersed for purposes not appropriate f<span style="font-size: small;">or a rese<span style="font-size: small;">arch grant</span></span>.</span>

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."<br /><br />It addresses the dangers of a common feature of EHR's used recklessly:  copy-and-paste. <br /><br /><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><br /><br />Copying and pasting information is common within EHRs,  but the practice sometimes can lead to confusion and endanger patient  care. <br /><div id="Byline"><br /></div><div id="Byline">By <span id="By"><a href="http://www.ama-assn.org/amednews/site/bio.htm#o%27reilly">Kevin B. O'Reilly</a>,</span> <span id="Tag">amednews staff.</span> <i>Posted Feb. 4, 2013.</i></div><div id="Byline"><br /></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"><br /></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"><br /></div><div id="Byline">That's somewhat ironic<i>. </i> 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"><br /></div><div id="Byline">Mr. O'Reilly continues:</div><div id="Byline"><br /></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.<br /><br />“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. “<b>We do rely on the chart in many cases,  and it can lead to genuine confusion.”</b></blockquote><br />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.<br /><br /><span style="mso-bidi-font-style: normal;"><span style="color: black; mso-bidi-font-size: 10.0pt;">From Sec. II of </span></span><i style="mso-bidi-font-style: normal;"><span style="color: black; mso-bidi-font-size: 10.0pt;">Aguilar v. Immigration and Customs Enforcement Div. of U.S. Dept. of Homeland Sec.</span></i><span style="color: black; mso-bidi-font-size: 10.0pt;"> 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>:</span><br /><br /><blockquote class="tr_bq"><span style="font-family: Arial,Helvetica,sans-serif;"><span style="font-size: small;">... 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. <b>This category of metadata reflects modifications to a document, such as prior edits or editorial comments</b>, 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. <i>Id</i></span></span></blockquote><br />Microsoft Word's "Track Changes" feature is an example of substantive metadata being displayed.<br /><br />The available stats on the phenomenon are of great concern: <br /><br /><blockquote class="tr_bq">... A study in February’s <i>Critical Care Medicine</i> found that copying and pasting is the rule in EHRs rather than the exception.<br /><br />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.<br /><br />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><br /><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"><br /></div><blockquote class="tr_bq">... Other times, patients are harmed. In a July/August 2007 case study in <i>AHRQ WebM&M</i>,  an online patient safety journal, William Hersh, MD, described the case  of a 77-year-old woman hospitalized for diarrhea and dehydration after  chemotherapy.<br /><br />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.<br /><br />“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"><br /></div><div>The American Medical News article continues:</div><div></div><br /><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><br /></div><div>That might serve to partially stem the process, but the HHS OIG's resources are not infinite.</div><div><br /></div><div>The article concludes:</div><div><br /></div><blockquote class="tr_bq"><div>John Halamka, MD, calls for a more radical fix.<br /><br />“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.”<br /><br />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><br />An interesting concept and experiment.  My questions:</div><div><br /></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, <u>before</u> experimenting with medical documentation? </li></ul></div><div><b><br /></b></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><br /></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 <u>future</u> 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. <br /><br />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 <span style="background-color: #cfe2f3;">had an eerily similar experience in the past:</span><br /><blockquote class="tr_bq"><b>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. </b></blockquote><blockquote class="tr_bq"><b>The irony is as follows. <span style="background-color: #cfe2f3;">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.</span></b></blockquote><br />Bryan Dylnacht, NYU School of Medicine, wrote:<br /><blockquote class="tr_bq"><b>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 </b><b><b>–</b> . . . will in fact succumb to mediocrity.</b></blockquote><br />William Kaelin of Harvard noted that<br /><blockquote class="tr_bq"><b>Trying to commercialize flawed science is a prescription for failure and waste.</b></blockquote><br />William C Hahn of Dana-Farber/Harvard Cancer Center wrote that::<br /><blockquote class="tr_bq"><b>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.</b></blockquote><br />John Petrini of Memorial Sloan-Kettering Cancer Center stated that<br /><blockquote class="tr_bq"><b>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.</b></blockquote><br /> The <i>Cancer Letter</i> <a href="http://cancerletter.live.subhub.com/articles/20121015_1" target="_blank">summed it up</a>:<br /><blockquote class="tr_bq"><div><b><span style="font-family: times new roman, times;">The scientific review council members are being followed by the vast majority of rank-and-file reviewers, . . . all from outside Texas. . . .</span></b></div></blockquote><blockquote class="tr_bq"><div><b><span style="font-family: times new roman, times;"><span style="white-space: pre;"> </span>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. </span></b></div></blockquote><blockquote class="tr_bq"><div><b><span style="font-family: times new roman, times;"><span style="background-color: #cfe2f3;">This walkout is an extraordinary act of solidarity on a scale never before observed in cancer science in the U.S.</span> 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. </span></b></div></blockquote><blockquote class="tr_bq"><div><b><span style="font-family: times new roman, times;">     The walkout—and, perhaps more so, the letters—send a powerful signal that <span style="background-color: #cfe2f3;">CPRIT is now outside mainstream cancer science. </span></span></b></div></blockquote><br /><blockquote class="tr_bq"><div><span style="font-family: times new roman, times;"></span></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 <i>no</i> 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<br /><blockquote class="tr_bq"><b>[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.</b></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 <i>Bloomberg Businessweek</i></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.<br /><br />A leader of the South Korean company stated:<br /><blockquote class="tr_bq"><b>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. </b></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 <i>strongly </i>disagrees with this shutdown:<br /><blockquote class="tr_bq"><b>Hopefully, the FDA will realize that what’s going on in Texas is good medicine and good economics.</b></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. <span style="background-color: #d0e0e3;">In this mental model, companies like Celltex are wonderful, inspiring examples</span>. Like it or not, this is the brave new world of rapid commercialization Perry visualizes and advocates – and understanding that vision <i>does</i> 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. <br /><br />The award had been presented to the Oversight Committeee and approved without going through <i>any</i> 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.<br /><br />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.<br /><br /><blockquote class="tr_bq"><b>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.</b></blockquote><br />Dr. Gilman, on the other hand, was very much<b> </b>blindsided.<br /><blockquote class="tr_bq"><b>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.</b></blockquote><br />When he discovered it, he was extremely angry.  Bill Gimson, the  executive director of CPRIT, wrote to a member of the Oversight  Committee:<br /><blockquote class="tr_bq"><b>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>.</b></blockquote><br />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:<br /><blockquote class="tr_bq"><b>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.’</b></blockquote><br />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 <i>already</i> awarded had gone to research. Matt Winkler, a member of CPRIT’s Scientific and Prevention Advisory Council, stated blandly<b>:</b><br /><blockquote class="tr_bq"><b>We should really get out of the business of copying what the NIH does.</b></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.<br /><br />Not science but business was the new order of the day at CPRIT<b>, </b>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:<br /><blockquote class="tr_bq"><b>We're going to reinvent ourselves on a regular basis.</b></blockquote>As to the celerity with which the grant was approved, he said:<br /><blockquote class="tr_bq"><b>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. </b></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:<b> </b><br /><blockquote class="tr_bq"><b>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.</b> </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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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 <i>Houston Chronicle</i> and <i>The Cancer Letter</i>.<br /><br />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:<br /><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><br />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).<br /><br />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>.  <br /><br />But then, it all fell apart.<br /><br />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.”<br /><br />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.   <br /><br />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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A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream.<br /><br /><b>The Goldacre Version in the New York Times in 2013 </b><br /><br />In his <a href="http://www.nytimes.com/2013/02/02/opinion/health-cares-trick-coin.html">op-ed</a>, Ben Goldacre introduced it thus:<br /><br /><blockquote class="tr_bq">the entire evidence base for medicine has been undermined by a <i>casual  lack of transparency</i>. Sometimes this is through a failure to report  concerns raised by doctors and internal analyses, as was the case with  Johnson & Johnson. More commonly, it involves the <i>suppression of  clinical trial results, especially when they show a drug is no good.</i></blockquote><br />He noted that this problems was supposed to be fixed by the registration of clinical trials, and by changes in editorial policies at medical journals:<br /><br /><blockquote class="tr_bq">many in the industry now claim it has been  fixed. But every intervention has been full of loopholes, none has been  competently implemented and, lastly, with no routine public audit, flaws  have taken years to emerge.        <br /><div itemprop="articleBody"><br /></div><div itemprop="articleBody"> The Food and Drug Administration Amendments Act of 2007 is the most widely cited fix. It required that new clinical trials  conducted in the United States post summaries of their results at clinicaltrials.gov within a year of completion, or face a fine of $10,000 a day.  But in 2012, the <a href="http://www.bmj.com/content/344/bmj.d7373">British Medical Journal</a> published the <a href="http://www.bmj.com/content/344/bmj.d7373">first open audit of the process</a>,  which found that <i>four out of five trials covered by the legislation had  ignored the reporting requirements. Amazingly, no fine has yet been  levied. </i></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">An earlier fake fix dates from 2005, when the International Committee of Medical Journal Editors <a href="http://www.icmje.org/clin_trial.pdf">made an announcement</a>:  their members would never again publish any clinical trial unless its  existence had been declared on a publicly accessible registry before the  trial began. The reasoning was simple: if everyone registered their  trials at the beginning, we could easily spot which results were  withheld; and since everyone wants to publish in prominent academic  journals, these editors had the perfect carrot. Once again, everyone  assumed the problem had been fixed. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">But four years later we discovered, in <a href="http://jama.jamanetwork.com/article.aspx?articleid=184503">a paper from The Journal of the American Medical Association</a>,  that the <i>editors had broken their promise: more than half of all trials  published in leading journals still weren’t properly registered, and a  quarter weren’t registered at all. </i></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Goldacre's conclusions were:</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">Withholding data not only <i>misleads doctors and  patients; it’s an insult to the patients who have participated in  clinical trials, believing that they were helping to improve medical  knowledge.</i> </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Medicine routinely overcomes enormous technical challenges, and there is  nothing complicated about the changes needed to prevent Johnson &  Johnson, or Roche — or anybody — from withholding information.</div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Hear, hear! </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>Our Version, Starting in 2003 </b></div><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Note that 10 years ago, in 2003, in my article on American health care dysfunction that could have been only published in Europe, (Poses RM. A cautionary tale: the dysfunction of American health care. Eur J Intern Med 2003 Mar;14(2):123-130.  Link <a href="http://www.ncbi.nlm.nih.gov/pubmed/12719032">here</a>)  I noted that an important cause of this dysfunction is that:</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">the scientific basis of medicine is increasingly under attack.</div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><i>The integrity of medical research has been violated by the deliberate suppression of its results.</i></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">At that time, I suggested one solution would be:</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div itemprop="articleBody">Medical schools and universities must re-affirm their support of scholarly work in the spirit of free enquiry,...</div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Furthermore, in <a href="http://hcrenewal.blogspot.com/2004/12/another-facet-of-ssri-suppression-of.html">one of our first posts</a> on Health Care Renewal in December, 2004, in the context of the discovery of internal company documents (in this case, from Eli Lilly) that showed that information about the adverse effects of a drug (in this case, increased aggression associated with fluoxetine, that is, Prozac), we wrote,</div><div itemprop="articleBody"><br /></div><blockquote class="tr_bq">The increasingly complex story of suppression of SSRI research seems to  be part of <i>a growing epidemic of suppression of medical research. </i></blockquote><blockquote class="tr_bq">Let's say it again. Withholding data from clinical research is unethical because:<br />1. <i> it breaks the promise to research subjects that their voluntary  participation has scientific or social value, but undisseminated  research has no value;</i> (See <a href="http://jama.ama-assn.org/cgi/reprint/283/20/2701.pdf">Emanuel EJ et al. What makes clinical research ethical? JAMA 2000; 283: 2701-2711.</a>)<br />2. it <i>impedes scientific progress;</i><br />3. it <i>prevents patients from receiving the best possible medical care.</i> </blockquote><blockquote class="tr_bq"><div itemprop="articleBody">But  <b><i>until this unethical behavior starts having negative consequences for  its perpetrators, the epidemic of research suppression is likely to  continue. </i></b></div></blockquote><div itemprop="articleBody"><br /></div><div itemprop="articleBody">Note the similarity to what Goldacre published in the Times yesterday.  <a href="http://hcrenewal.blogspot.com/search/label/You%20heard%20it%20here%20first">You heard it here first</a>. </div><div itemprop="articleBody"><br /></div><div itemprop="articleBody"><b>Summary </b></div><div itemprop="articleBody"></div><div itemprop="articleBody">To date we have published 102 posts with the label "<a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression of medical research</a>."  Obviously, Ben Goldacre's NY Times op-ed shows that suppression of research still rarely leads to negative consequences for its perpetrators.  Obviously, by making drugs, devices, and other health care interventions appear safer and more effective than they really are, suppression of medical research has lead to huge revenues for health care corporations, and has made many health care executives exceedingly rich, and many of the health care professionals and academic leaders who have enabled or implemented research suppression somewhat rich.  In the face of such <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse incentives</a>, until we end the <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a> of those who suppress medical research (and by the way, those who authorize, direct, or implement all sorts of other unethical, criminal and corrupt behavior we discuss on Health Care Renewal) things will not get better.  I can only hope that having this subject appear in a New York Times op-ed may lead to some real progress.<br /><br />ADDENDUM (2 February, 2013) - see also <a href="http://1boringoldman.com/index.php/2013/02/02/watchful-waiting-no-more/">comments</a> on 1BoringOldMan blog.  </div><div itemprop="articleBody"><br /></div>

A Condemnation of Suppression of Medical Research... by Ben Goldacre in the New York Times

Amazingly, this topic now seems to be in the mainstream. The Goldacre Version in the New York Times in 2013 In his op-ed , Ben Goldacre intr...

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