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.
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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. 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."

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" remarkable.

The reverse actually applies in my opinion.  In medicine, "we" (well, not I) actually fail to make repeated anecdotes (like these and these) 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
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From One Child to Taking on the World


Hello Friends!  How I have missed you all.  So much has happened since the last time I have blogged with Texas Health Moms, and there is so much to catch up on!

So if there are moms out there that only have one child that are planning to have a second, please do not let what I am about to say scare you.  There is a silver lining at the end of this, so please read all the way through to the end.

Having one child is a cake walk.  Having two children is exploding that cake into your face while you are driving 80 miles per hour down the Dallas North Tollway 30 minutes late for soccer practice with the newborn screaming for a feeding in the backseat with a dirty diaper and the older child complaining that their shin guards are scratchy and he didn’t want to wear these particular shoes because his teammate bought these same shoes the other day and now he won’t be the only player that has them and now it is so uncool and WHYYYYYYYYYYYYYYY can’t you just buy me a new soccer ball because this one is dirty and just plug in your phone so I can hear my favorite song because your music is so uncool and pass me my water because I’m so thirsty and what’s taking so long?

I’m not joking.

Ok, so deep breath everyone.  Really, the deep breath was only for my benefit.

I realize now how easy I had it with only one child; especially a 9 year old who was really so self-sufficient and really mature for his age.  I used to wonder why there were so many moms of two or three children out there that were sans makeup and crazy hair out there.  How could they leave the house with mismatched clothes?  I mean, come on women, get it together!  Pffffft!  It was not passing judgment on my part.  Ok, it was.  Perhaps ignorance on my part.  I can totally relate now.

For example, I had a couple of hours to myself one Saturday.  I picked out a cute outfit, managed to get my hair somewhat presentable, and threw on some makeup.  I looked totally cute!  I picked up my adorable baby, gave her a quick squeeze, gave my son and husband a hug, and drove my SUV as fast as I could to Target.  I picked myself up a tall, skinny vanilla latte and cruised the aisles as slowly as my feet would take me.  I mean, this is the mecca of new Mom-dem.  I picked up a few things, and headed home.  Once home on my Target-I’m-wearing-a-cute-outfit-high, I realized something as I looked in the mirror.  I had dried spit up running down my shoulder and all the way down my back.  Yes, this was my new life.  My new normal.

But as I live my new normal, I’ve learned so much more.  When I do finally get to sit and spend time together as a family, these are the special times I’ve earned.  All the stress, all the chaos, all the rushed moments, are all because we are one.  One family.  One love.  And I look at the smiles, and know it is all worth it.


Janet Fragle works in customer engagement for innovative technology solutions at Texas Health Presbyterian Hospital Plano and is Mom to a 9-year-old boy and 3-month-old girl. 

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The Story of CPRIT Continued, Part 4: The Walkout

Gilman’s resignation, though tendered in May, was effective in October. He wanted to shepherd grants that had already been through peer review but which were not yet actually funded through funding if possible, particularly as they had been delayed in the spring at the same time as the IACS grant was approved. He asked his peer reviewers to hang in with him through October. It is clear that he really tried his hardest to get a change in the new revised course of CPRIT – but he lost, and completely. He tried to get agreement that future commercialization projects would be subject to scientific review – and he got absolutely nowhere on this. He did succeed in getting delayed grants seen through the funding process; and then, in October, he left – and so did most of the peer review panelists he had assembled. Seven of eight scientific review council members resigned, and so did probably around 70 of the approximately 100 out-of-state cancer researchers and clinicians who comprised the peer review panels.

Some of the 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.

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Testimonials to Surviving Cancer

Description: http://psychologist-nh.com/wp-content/uploads/2011/09/Psychologist-NH-Surviving-Cancer-NH-Psychologist.jpg

'My name is Annmarie and I’d like to thank you for your research and for making it available to us. My children were able to enjoy another summer with their grandfather, 74, who had been diagnosed with 4th stage kidney cancer last November, and we give glory to the Lord for helping us to find your Sodium Bicarbonate book, which we believe helped save his life. My father-in-law was declared cancer free this past May! We spent two weeks with him in northern Wisconsin boating and fishing and just enjoying spending time with him. I thought I would share this good news with you!

I have been getting letters mirroring the medical conclusions I am making at the end of years of research. I am very happy to announce that I have a cutting-edge protocol that addresses cancer in a take-no-prisoners approach. The Natural Allopathic Medicine Protocol is aggressive in penetrating down into the deepest roots of physiology and pathology of cancer but it does so gently because it uses safe, nurturing substances—some of which can save a life in a heartbeat.'

Read more...
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