ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis

As I wrote here, I was a reviewer of the report in the PA-based, ECRI Institute-conducted study "The Role of the Electronic Health Record in Patient Safety Events."  ECRI studied the Pennsylvania Patient Safety Reporting System database for HIT-related errors.   

The ECRI Institute is an independent organization renowned for its safety testing of medical technologies and reporting on same, and that "researches the best approaches to improving the safety, quality, and cost-effectiveness of patient care."  I've mentioned it and its bylaws in this blog in the past as a model for independent, unbiased testing and reporting of healthcare technologies.

The full report in PDF is at this link.  In the report, the Pennsylvania Patient Safety Authority analyzed reports of EHR-related events from a state database (the Pennsylvania Patient Safety Reporting System or PA-PSRS, pronounced "PAY-sirs") of reported medical errors and identified several major themes.

My review input led to a discrete "limitations" section.  Also, my invited July 2012 presentation to the PA Patient Safety Authority "Asking the Right Questions: Using Known HIT Safety Issues to Improve Risk Reporting and Analysis" with ECRI in attendance (link to PPT here) on the danger of limited datasets due to systematic impediments to information diffusion was apparently taken seriously. 

ECRI decided to do something about the knowledge gap, and they asked the right questions.

They've just released this summary of a new study they conducted.  I have a few comments which follow:
  

ECRI Institute PSO Uncovers Health Information Technology-Related Events in Deep Dive Analysis

Data transfer, data entry, system configurations, and more identified as serious problem areas
 
PLYMOUTH MEETING, Pa., Feb. 6, 2013 /PRNewswire-USNewswire/ -- The federal government is spending about $19 billion to encourage hospitals, physician practices, and other healthcare organizations to invest in their health information technology (HIT) infrastructure with the goal of improving patient safety and quality through the Health Information Technology for Economic and Clinical Health (HITECH) Act.

Concerned about the unintended consequences of HIT and the potential for errors to cause patient harm, ECRI Institute Patient Safety Organization (PSO) recently conducted a PSO Deep Dive™ analysis on HIT-related safety events. Their just-released 48-page report identified five potential problem areas, which can be assessed with the accompanying toolkit. The report and toolkit are available for purchase [appx. $350 U.S. - ed.] without membership in ECRI Institute PSO.

"Minimizing the unintended consequences of HIT systems and maximizing the potential of HIT to improve patient safety should be an ongoing focus of every healthcare organization," says Karen P. Zimmer , MD, MPH, FAAP, medical director, ECRI Institute PSO.

Based on [voluntary - ed.] reports submitted to the PSO from participating organizations, ECRI Institute PSO experts identified the following key HIT-related problems:

• inadequate data transfer from one HIT system to another
• data entry in the wrong patient record
• incorrect data entry in the patient record
• failure of the HIT system to function as intended
• configuration of the system in a way that can lead to mistakes

To collect enough reports for meaningful evaluation, ECRI Institute PSO asked participating organizations to submit standardized data about HIT events during a nine-week period. This enabled ECRI Institute PSO to identify patterns and trends from the aggregated data and share the findings, as well as its recommendations. The data in the PSO Deep Dive represents only that collected using the Agency for Healthcare Research and Quality (AHRQ) HIT Common Formats.  [Not the improved formats developed by AHRQ in their IT Hazards Manager project, still in development - ed.]  ECRI Institute PSO data encompasses over 800 HIT-related events.

According to the report, HIT must be considered in the context of the environment in which it operates during the three phases of any HIT project: planning for new or replacement systems, system implementation, and ongoing use and evaluation of the system. "Shortsighted approaches to HIT can lead to adverse consequences," caution the authors.

"Healthcare organizations should consider the findings and recommendations in the PSO Deep Dive as part of their effort to achieve those goals," adds Zimmer.

The HIT PSO Deep Dive findings were published in a 48-page report and toolkit with self-assessment questionnaire and action plan form available to all ECRI Institute PSO Members and its partner PSO members. The table of contents of the report is available for free viewing/download. Additional information will be presented in ECRI Institute PSO's Monthly Brief free e-newsletter March edition; go to www.ecri.org/psobrief to sign up. The full report and toolkit are also available for purchase.

For questions about this topic, or for information about purchasing the report, please contact ECRI Institute PSO by telephone at (610) 825-6000, ext. 5558; by e-mail at pso@ecri.org; by fax at (610) 834-1275, or by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA.

From the free linked TOC document:

Key Recommendations

• Enlist leaders’ commitment and support for the organization’s health IT projects.

• Involve health IT users in system planning, design, and selection.

• Conduct a review of workflow and processes to determine how they must be modified.

• Evaluate the ability of existing IT systems within the organization to reliably exchange data with any health IT system under consideration.

• Conduct extensive tests before full implementation to ensure that the health IT system operates as expected.

• Provide user training and ongoing support; educate users about the capabilities and limitations of the system.

• Closely monitor the system’s ease of use and promptly address problems encountered by users.

• Introduce alterations to a health IT system in a controlled manner.

• Monitor the system’s effectiveness with metrics established by the organization.

• Require reporting of health IT-related events and near misses.

• Conduct thorough event analysis and investigation to identify corrective measures.

My comments are these:

• The ECRI study, report and recommendations are quite welcome.

• The case reports received were apparently voluntary and probably "conservative" and understated as hospitals are not happy to release data on problems and harms that can lead to, or support, litigation.  

• The study was just 9 weeks long, and with a limited set of healthcare organizations participating.  800 HIT-related events were identified. 

•  The relevant issues discovered in the events, as summarized in the bullet points above, are capable of causing clinician distraction, incorrect decisions, "use error" (as opposed to "user error", see here), patient harm, and death.  (I am aware of such issues in the press including harms and deaths, as readers here have read at links such as these and these and these and these, and others about which I am providing expert-witness consultation and cannot share.)
  

• I believe ECRI has now begun to peer below the water level, through the muck of industry control of the narrative, of what FDA CDRH leader Jeffrey Shuren MD JD referred to as "the tip of the iceberg" - i.e., the current level of knowledge of health IT difficulties, defects and harms. 

• The report is yet another red flag for a far more robust (and mandatory, in my view) post-marketing surveillance of health IT.  

• Those who claim these findings are "anecdotes" (as here) are looking increasingly foolish and cavalier.

Finally, readers of this blog have been reading about these issues for years.  You heard it here first.

-- SS 
 

New York Mayor Bloomberg: Gun Control - Yes, Bad Health IT Control - No?

The Mayor of New York, Bloomberg, calls for anti-gun legislation because accidents and unexpected events such as theft or use by a child can happen, even with legally owned guns (I don't think he believes law-abiding citizens who own them for defense or for sport would break the law with them).

Yet the selfsame Mayor uncritically calls for spread of another technology that in its present state is prone to accidents and unintended consequences, and unlike guns, at a level that even the Institute of Medicine has admitted in unknown due to systematic impediments to transparency (see the middle of this post for source).

From a release at MikeBloomberg.com:

Mayor Bloomberg Announces Expansion of Electronic Health Records Result in Major Health Care Improvements
Feb 07, 2013 | NYC.gov

Mayor Bloomberg, Deputy for Health and Human Services Linda I. Gibbs, Health Commissioner Thomas A. Farley today announced that the use of electronic health records has led to better health outcomes for tens of thousands New Yorkers in the critical areas of high blood pressure management, diabetes and tobacco control.

New York City's introduction of electronic health records, which has become a national model, was a result of the Primary Care Information Project, a program that began in 2005 to help medical providers, particularly those with underserved patients, use technology to improve the quality and efficiency of health care. The prompts that electronic health records give doctors, such as signaling a daily dose of aspirin to prevent heart disease or follow up questions for someone who smokes, make a dramatic difference in how aggressively they treat the chronic health conditions of their patients.

Through 3,200 primary care providers serving more than three million New Yorkers with electronic health records, over 96,000 additional patients reduced their high blood pressure, 81,000 patients improved their diabetes management and an additional 58,000 smokers were given assistance and successfully quit. The Mayor made the announcement at the “NYC Celebrates Improved Health Through Technology” event at the New York Institute of Technology where he was joined by Centers for Disease Control and Prevention Director Dr. Thomas Frieden, National Coordinator for Health Information Technology Dr. Farzad Mostashari and Director of Health Services Andrea Cohen.

There is no doubt the technology can accomplish such goals.  The IT I authored or spearheaded at major hospitals improved quality of care in areas such as diabetes and asthma care, invasive cardiology, and others.

The release, however, is missing the most important points.

The issue is not whether benefits can accrue from health IT.

The issues are ... at what level of harms in its present state, since the technology is unregulated and unvetted for potential risks, and also - are there simpler and cheaper ways to accomplish these ends, e.g., so that the underserved can get more access to care.

There is no mention of unintended harms, or even concern about harms, in the release - the very same harms mentioned by Joint Commission, FDA, Institute of Medicine (for example see JC, FDA, IOM) and many others.

That qualifies the press release as propaganda.  It is not balanced, almost like an ad for, say, VIOXX.

Apparently, for the Mayor it's OK to have increased risk and innocent victims due to bad health IT (like these and these and these and these, and others I cannot talk about due to case settlements), but not innocent victims of legally owned but stolen guns.

Medicine's tradition for centuries has been "first, do no harm", not "when you have benefits to the many, it's OK to overlook the risks and the roadkill."

We don't tolerate that any more from the likes of Merck, Pfizer, or Medtronic (to name a few examples).

Why does health IT always get special accommodation, as I have frequently asked?

With new federal funding for 2013, NYC REACH is now working to help behavioral health professionals and specialists with high numbers of Medicaid patients adopt and implement electronic health records to continue to improve care across the City.

Let's hope they don't have an Avatar rerun (link) or Contra Costa meltdown (link, link).

Note: this post is not about gun control, a complex issue unto itself, but about medical ethics and hypocrisy. 

-- SS

Feb. 8, 2013 Addendum: 

Prof. Jon Patrick of U. Sydney opines:

I can only say the story is a well crated ANECDOTE.

The pertinent text is this:

Between 2008 and 2011, the number of preventive care services participating doctors provided grew, on average, by about 290%, from 39 services per 100 patients to 113 services per 100 patients – nearly a threefold increase.

Which tells us the only tangible piece of information in that services are increased - where are the figures from the EDs or hospital intakes that show the number of visits for these diseases have gone down?

The other interesting point is the valid claim of better analytics - but they don't say how they were used, if at all:

"Patients served by doctors participating in the program were, for example, reminded to take daily aspirin doses to prevent heart disease or counseled to quit smoking. Electronic Health Records also permit doctors to view data on their entire population of patients, which helps them modify their routine office practices to help all of their patients and then evaluate how well those changes work."

-- SS

From Parallel Universes? Dueling Accounts of VA/DoD EHR Integration

At a March 2010 post "VA / DoD EHR Interface Debacle: Will It Take the Luminosity Of A Dozen Supernovas To Shed Light On The Obvious About Healthcare IT?" I wrote about problems with ongoing efforts to integrate the Veteran Administration's EHR and the Dept. of Defense (active military) EHR.

Now there appears to be two dueling accounts of the task's progress:

Account One:

DOD, VA to Speed Integration of Health Records
By Jim Garamone
American Forces Press Service

WASHINGTON, Feb. 5, 2013 – The secretaries of Defense and Veterans Affairs announced their departments will speed implementation of the Integrated Electronic Health Record program, allowing service members and veterans better access and more importantly, better medical care.


This approach is affordable, achievable, and if we refocus our efforts we believe we can achieve the key goal of a seamless system for health records between VA and DOD on a greatly accelerated schedule,” said Defense Secretary Leon E. Panetta following a meeting with Secretary of Veterans Affairs Eric Shinseki at VA headquarters here.

The departments are able to step up the records program because of advances in information technology while working with existing platforms. The original goal was to have the system deployed by 2018. Now the expectation is by the end of next year.

The goal is to provide one set of electronic records from entry into the military through veteran status. The program is designed to allow service members or veterans to download information and present it to doctors or other health care providers without delays.

Previously, service members had to hand carry paper files from DOD facilities to Veterans Affairs. Once complete, the record program will provide DOD and VA clinicians with the complete medical records of more than 18 million service members, veterans and their beneficiaries.

“We’ve agreed to improve interoperability before the end of this year by standardizing health care data,” Shinseki said. The two departments will also accelerate the exchange of real-time data by September. The departments are upgrading the graphical user interface to display the new standardized VA and DOD healthcare data by the end of this year, Shinseki said.

... “By this summer, DOD and VA will field and begin conducting a pilot program on the common interface for doctors at seven joint rehab centers across the country and we’ll also expand its use at two other sites,” Panetta said. “All of these facilities will be interoperable by the end of July 2013, so fast time track, but we think we can get it done.”

“Rather than building a single, integrated system from scratch, we will focus our immediate efforts on integrating VA and DOD health data as quickly as possible by upgrading our existing systems,” Panetta said.

 

Account Two:

IMMEDIATE RELEASE: February 6, 2013 CONTACT: Curt Cashour (202) 225-3527

Senate and House Veterans’ Committee Leaders Fault VA and DoD on Integrated Health Record System

WASHINGTON, D.C. – The chairmen and ranking members of the Senate and House Committees on Veterans’ Affairs today faulted the Pentagon and Department of Veterans Affairs for backing off plans to create a single computer system to integrate electronic medical records for troops and veterans.

Senate Committee on Veterans’ Affairs Chairman Bernie Sanders (I-Vt.) said: “I am deeply disappointed by the VA and Defense Department decision to back away from a commitment to develop and implement a truly integrated, single, electronic health record. President Obama charged the departments with creating a seamless system of integration so that service members transitioning from active duty to civilian life don’t have to worry about whether their health records will be lost or their claims delayed. An integrated record would allow for a streamlined and timely claims process, faster decisions on benefits, less duplication in medical testing and more efficient, cost-effective treatment for both physical and mental health needs. Now more than ever we need greater cooperation between the departments to solve the serious challenges that continue to confront our service members and veterans. I will continue to work to achieve better coordination by the departments and to ensure that the needs of veterans are met.”

House Committee on Veterans’ Affairs Chairman Jeff Miller (R-Fla.) said: “The decision by DOD and VA to turn their backs on a truly integrated electronic health record system is deeply troubling. The need for a record system integrated across all DOD and VA components has been universally accepted for years, and until yesterday, both agencies have given us nothing but assurances they were working toward that goal.

Previous attempts by DOD and VA to use disparate computer systems to produce universal electronic health records have failed, and unfortunately it appears they are repeating past mistakes.  [This seems the "focal point" of the apparent discrepancy, one system vs. two that are interfaced - ed.]  When DOD and VA take shortcuts, the veterans and service members under their care will be shortchanged.”

Sen. Richard Burr (R-N.C), the ranking member of the Senate committee, said: “The fact that VA and DoD would reverse course on a plan they have been working towards for years that would create a coordinated electronic health record system between the two agencies is concerning and disappointing. I am concerned about what this means for our nation’s service members and veterans, particularly those who will be transitioning from active duty service to civilian life in the near future. We owe it to our nation’s defenders to do all we can to care for them and provide the most effective, efficient service we can, and coordination and communication between these two agencies is absolutely vital.”

Rep. Mike Michaud (D-Maine), ranking member of the House committee, said: “This is a huge setback and completely unacceptable. For years we have been told by both agencies that progress was made and that things were on track. I’m disappointed that our nation’s two largest government agencies – one of which is the world’s foremost developer of high-tech machines and cyber-systems – could not come together on something that would have been so beneficial to those that served. We have just witnessed hundreds of millions of dollars go down the drain.”

Additional Contacts:
Michael Briggs (Sanders) 202 224-5141
David Ward (Burr) 202 228-2971
Ed Gilman (Michaud) 202 225-6306

So, some are touting a marvelous effort ready for prime time in 2014, and others are speaking of hundreds of millions of dollars down the drain with nothing to show for it.

As Captain Kirk said to Mr. Spock in the award-winning Star Trek episode "The City on the Edge of Forever" about conflicting accounts of the early 1930's death of Edith Keeler, played by a pre-Dynasty Joan Collins, vs. Keeler's mid-to-late-1930's rise to national fame and her becoming the cause of World War Two being lost ... "They both can't be true." 

(Using the clock-mender's tools, Spock gets an image on his tricorder screen of a newspaper report. Edith Keeler, social worker from 21st Street Mission was killed today, it says. Kirk enters.)
KIRK: How are the stone knives and bearskins?
SPOCK: I may have found our focal point in time.
KIRK: You may also find you have a connection burning someplace.
SPOCK: Yes. I'm overloading those lines. I believe we'll have our answer on this screen.
KIRK: Good.
SPOCK: And, Captain, you may find this a bit distressing.
KIRK: Let's see what you have.
SPOCK: I've slowed down the recording we made from the time vortex.
KIRK: February 23rd, 1936. Six years from now. (reading below the headline FDR confers with slum area 'angel') The President and Edith Keeler conferred for some time today
(Then the whole thing goes up in flames.)
KIRK: How bad?
SPOCK: Bad enough.
KIRK: The President and Edith Keeler.
SPOCK: It would seem unlikely, Jim. A few moments ago, I read a 1930 newspaper article.
KIRK: We know her future. Within six years from now, she'll become very important. Nationally famous.
SPOCK: Or Captain, Edith Keeler will die - this year. I saw her obituary. Some sort of traffic accident.
KIRK: You must be mistaken. They both can't be true. 

Based on the points I raised in the aforementioned March 2010 post about current IT leadership and organizational structures (not to mention Beltway Bandit IT consultants), I am skeptical that either plan - monolithic vs. interfaced - has a snowball's chance of success.

Edith Keeler dies in either scenario. 

Let's just hope a war is not lost because of this cybernetic "how to do health IT poorly" feud.

-- SS

Feb. 7, 2013  Addendum:

I've received a comment that this post is a bit "geeky" but droll.

My response is a word often used by another highly popular SF character:  Indeed.

-- SS

More on the lengths a hospital will go through to protect their EHR from discovery

At "The lengths a hospital will go to in order to protect their EHR - Motion for Reconsideration of Denial of Motion for Reconsideration of Denial of Objections" I wrote about obstruction of litigation by the defense regarding a case where an EHR contributed to patient injury and death.

The major basis for the new "Motion for Reconsideration" (a request for the court to reconsider its prior denial of an earlier Motion for Reconsideration of an initial court decision to dismiss defense objections to the Complaint) is this.  From the actual filing (emphases mine):

(click to enlarge)

Here is likely why the court "never addressed the issue":  they don't have time to address frivolous claims.  Neither does the Superior court that also declined to hear this argument.  (It's actually the defense who never addressed the following in all their filings):

From the official publication of the Civil Procedure Rules Committee in the state, effective a decade ago:

That's pretty clear.  One certificate for non-defendants for whom the defendant is vicariously liable.  Further, a decade ago recommendation 200 also was approved and added to the note; the medical professional providing the justifying statement doesn't even need to name the 'other professionals who deviated.'

The mandated Certificate was timely filed, as was a separate Certificate of Merit for direct corporate liability in the malpractice suit.

Further -  from the actual mandated Certificate of Merit document, direct from the State code:

I don't think the Courts expect parties to edit their documents to accommodate their own whims.

The only option for identifying those sued is “Name of Defendant.”  No fields are present specifying “Name(s) of Defendant’s agent, employee (etc.) for whom Defendant is being held vicariously liable”, or similar, nor is some other multi-labeled Certificate of Merit for such purposes in existence.

This is some rather inventive lawyering and misuse of court process, either to needlessly prolong the case, or to harass the plaintiff.  The judges will likely not be amused.

On the other hand, the delays have allowed me to be able to see and review metadata (e.g., audit trails and other "data about data") produced from the very same EHR system that was in use at this hospital, via my legal support work in another case in the state.  It took time for that production to occur.  This will make it much harder for the hospital to pull the wool over my eyes regarding metadata discovery.

That's one reason why I'd been patient with all this.

My patience is now long expired.

My mother, the original plaintiff, is unavailable for comment.

-- SS

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:

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.

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 Health Care's Trick Coin). 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!

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:

Why is CPRIT even funding commercial enterprises? Didn't voters expect the bond money to support research?

[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: 

The vision was to make Texas the center for curing cancer. It wasn't to make Texas the center for capitalizing on cancer.

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:

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.

In an October appearance at CPRIT, Perry stated:

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.

As The Cancer Letter tartly observed :

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.

Interviewed by the Houston Chronicle in January, Perry continued in the same vein: 

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.

Matt Winkler, a member of CPRIT's Scientific and Prevention Advisory Council, last week expressed his opinion to the Austin Statesman 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:

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.

Disagreeing strongly with these ways of thinking,Walt Goodpastor, who lost a son to cancer, angrily wrote: 

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.

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.

I believe that the most bang for our buck would come from awarding grants to independent individual scientists who are working on promising leads.

And the Houston Chronicle editorialized on January 15:

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.

     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.

Nobel laureates Gilman and Sharp, who had led the walkout, wrote their own editorial, which says in part: 

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. . .

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. 

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 may have been 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 were raised about the CPRIT Foundation, 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, names of donors were revealed. These included donations from pharmaceutical and drug development companies, and from people associated with companies that had received CPRIT awards.

And a state audit came out in late January, 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.

AMA News: Dangers of "EHR Sloppy and Paste" - And Why Was An Informatics Expert Apparently For "Anecdotes" Before He Was Against Them?

In the AMA News an 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.

EHRs: “Sloppy and paste” endures despite patient safety risk

Copying and pasting information is common within EHRs, but the practice sometimes can lead to confusion and endanger patient care.

By Kevin B. O'Reilly, amednews staff. Posted Feb. 4, 2013.

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.”

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.

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 this multimillion-dollar federal lawsuit for billing fraud.)

Mr. O'Reilly continues:

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.”

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 this link:

... 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

Microsoft Word's "Track Changes" feature is an example of substantive metadata being displayed.

The available stats on the phenomenon are of great concern:

... 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.

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:

... 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.

That caught my eye.

This is the same Dr. Hersh who in Sept. 2010 in an American Medical Informatics Association mailing list, regarding the issue of risk and "anecdotes", accused me of not knowing my field, as I documented at this link:

... At "Health IT: On Anecdotalism and Totalitarianism" I posted these thoughts:

At the article Blumenthal on EMRs: Debate "raging" over competition vs. standards, ONC czar David Blumenthal is cited as saying several interesting things:

... EMRs make him a better physician, he said, recounting personal anecdotes of discovering patients' allergies through automated EMR alerts and using stored image date to more quickly get a diagnosis for a patient without subjecting them to more radiation and toxic radiation agents ...

It's the EMR "anecdotalists" (as opposed to the "Markopolists") who say that "anecdotes" of HIT-related injury are meaningless. They deem reports of safety issues and HIT-related misadventures and risk as simply "anecdotal", and that "anecdotes don't make evidence" (or "anecdotes don't make data").

Yet anecdotal reports of EMR "saves" are used by a czar to justify tens of billions of dollars of expenditures?

To the anecdotalists, I say: you can't have it both ways.

I also posted nearly the same complete Healthcare Renewal post to several mailing lists of the American Medical Informatics Association including the Clinical Information Systems working group (CIS-WG). CIS-WG is a mailing list read by something over 1000 healthcare informatics professionals at last time I had access to the statistics a few years ago.

I received some supportive replies from colleagues, including collaborators on the AHIMA (not AMIA) book we co-authored in 2009 entitled "H.I.T. or Miss: Lessons Learned from Health Information Technology Implementations" - itself not exactly a popular exercise among the strictly positivist informatics leadership class.

Now, I thought my posting on the double standard regarding "anecdotes" highly straightforward. From a high ranking academic leader of a major national informatics program, Bill Hersh at OHSU, however, the following reply was posted:

Scot,

For someone who is a faculty in informatics, I am surprised at how unfamiliar you are with the literature. There is solid evidence, much more than anecdotes, on the efficacy of health IT. Even Dr. Blumenthal himself has posted on that. (I think you are taking this quote out of context.

I am then served a platter of literature I must be "unfamiliar with" such as:

Goldzweig, C., Towfigh, A., et al. (2009). Costs and benefits of health information technology: new trends from the literature. Health Affairs, 28: w282-w293.

[Note - I had commented on and linked to this very article at this Aug. 29, 2010 post - ed.]

Garg, A., Adhikari, N., et al. (2005). Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. Journal of the American Medical Association, 293: 1223-1238.

Amarasingham, R., Plantinga, L., et al. (2009). Clinical information technologies and inpatient outcomes: a multiple hospital study. Archives of Internal Medicine, 169: 108-114.

Longhurst, C., Parast, L., et al. (2010). Decrease in hospital-wide mortality rate after implementation of a commercially sold computerized physician order entry system. Pediatrics, 126: 14-21.

Now, aside from the serious breach of academic etiquette of attacking the competence of your colleagues in a public forum, I seem to be hearing that it's OK to purvey positive anecdotes about health IT (usually based on weak retrospective observational studies alone, not randomized clinical trials), but not anecdotes of HIT malfunctions or of HIT-related adverse outcomes, since there's 'solid evidence' of the efficacy of health IT.

In plain English, an ad hominem fallacy is followed by an appeal to authority of sorts ("the literature") to justify public Pollyanna attitudes towards HIT by high ranking officials. And since the literature is so glowing, negative anecdotes must be of low worth.

I never received an apology for this.  Apparently Dr. Hersh was for "anecdotes" before he was against them.

I've had an email exchange with him just a little while ago on this, and his expressed point of view is that:

"After all these years, you still do not understand what I am saying. Kinda sad, actually.  Anyways, there is a role in medical science for anecdotes, sometimes called case reports. [Conflation of science and risk management is quite apparent here; see Australian essay linked below - ed.]  They are, however, the least strong type of evidence. We make inferences and broad pronouncements about them at our own peril, though you seem to do this years after your one anecdote [my mother's death from a 2010 accident - ed.], which I have always acknowledged was personal and devastating to you."

Readers of this blog will probably be puzzled at the implication that my "one anecdote" is all that I am 'making inferences' about.  (Actually, I am making recommendations about caution traditional in medicine.)  I leave it to readers to decide as to why an informatics program director and AMIA leader would make such a statement.

My reply was polite, reminding Dr. Hersh that my writings on HIT problems began in 1998, not 2010, and were largely ignored by the informatics and HIT community (other than "iconoclasts").  I included the recent Modern Healthcare article "HIT Iconoclasts" and a link to the post about anecdote vs. science at "From a Senior Clinician Down Under: Anecdotes and Medicine, We are Actually Talking About Two Different Things" here.

That is all I can and will do.

That said, I find the statement "We make inferences and broad pronouncements about [anecdotes, sometimes called case reports] at our own peril" rather remarkable on its face.

The reverse actually applies in my opinion.  In medicine, with its ethical considerations and obligations, and especially in the domain of EHR's with its known, reported, systematic impediments to adverse information diffusion per JC, FDA, IOM and others, the following is true:

"We" (well, not I) actually fail to make repeated anecdotes (like these and these and these and these, and others I cannot talk about due to case settlements) a top priority as a red flag for systemic, rigorous investigation, e.g., formal, transparent HIT premarketing evaluation and postmarket surveillance and a regulatory infrastructure, at patients' peril.

And, in case anyone was wondering, it's not exactly endearing to refer to the death of someone's mother as an "anecdote" or even a "case report", but I digress.

The AMA News article continues:

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.

That might serve to partially stem the process, but the HHS OIG's resources are not infinite.

The article concludes:

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.

An interesting concept and experiment.  My questions:

• 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?  

• Do we get informed consent from patients for the experiment?

• 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?

• 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?

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.

-- SS

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 resignation letters make interesting reading. Scott Kern of Johns Hopkins said he had had an eerily similar experience in the past:

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. 

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.

Bryan Dylnacht, NYU School of Medicine, wrote:

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.

William Kaelin of Harvard noted that

Trying to commercialize flawed science is a prescription for failure and waste.

William C Hahn of Dana-Farber/Harvard Cancer Center wrote that::

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.

John Petrini of Memorial Sloan-Kettering Cancer Center stated that

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.

 The Cancer Letter summed it up:

The scientific review council members are being followed by the vast majority of rank-and-file reviewers, . . . all from outside Texas. . . .

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. 

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.

     The walkout—and, perhaps more so, the letters—send a powerful signal that CPRIT is now outside mainstream cancer science.

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

[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.

A recent and excellent article in Bloomberg Businessweek 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, with the permission of the Texas Medical Board, 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 himself received the treatment after his back operation, done by Dr. Jones, in summer 2011.

A leader of the South Korean company stated:

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.

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:

Hopefully, the FDA will realize that what’s going on in Texas is good medicine and good economics.

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.

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, IACS (Institute for Applied Cancer Science), 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 not at all in the regular way 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, recounted in a May email that he had run into DePinho in October at the annual meeting of the American Academy of Arts & Sciences.

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.

Dr. Gilman, on the other hand, was very much blindsided.

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.

When he discovered it, he was extremely angry.  Bill Gimson, the executive director of CPRIT, wrote to a member of the Oversight Committee:

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 not an incubator because it is research.

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:

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.’

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:

We should really get out of the business of copying what the NIH does.

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:

We're going to reinvent ourselves on a regular basis.

As to the celerity with which the grant was approved, he said:

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.

 Dr. DePinho wrote the Houston Chronicle to contend that: 

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.