Inside the first scandal in patient safety

In retrospect — always in retrospect — it should have been obvious that, when it came to Dr. Charles Denham, something was not quite right.

In a remarkable number of cases of medical errors, it’s clear — again, in retrospect — that there were signs that something was amiss, but they were ignored. The reasons are manifold: I was just too busy, things are always glitchy around here, I didn’t want to be branded a troublemaker by speaking up…. Part of the work of patient safety has been to alert us to this risk, to get us to trust our internal “spidey-sense.” When something seems wrong, we tell front-line clinicians, speak up!

It’s fitting, then, that the first major scandal in the world of patient safety has a similar subtext. The scandal involves a $40 million fine levied by the Department of Justice against a company called CareFusion. The company allegedly paid Denham more than $11 million in an effort to influence the deliberations of a “safe practices” committee of the National Quality Forum co-chaired by Denham. While I was shocked to hear this news, in retrospect there were so many unusual things about the career of Chuck Denham that alarm bells could have, okay, should have, gone off — for many people who knew him, including me. But they didn’t.

Let me say at the outset that while some people feel strongly that leaders in safety and quality should have absolutely no ties with industry, I am not one of them. I serve on a corporate board (of IPC, the largest hospitalist staffing company in the US) and advise several companies working on various safety fixes, mostly technologies. I find this work interesting, enlightening, and fulfilling, and I am compensated for my time and expertise. I report all of these activities to my university and other organizations, and recuse myself from any decision that might possibly relate to one of these companies or their products, or potentially be perceived that way (a fuller description and a list of the companies is here).

Returning to the CareFusion/Denham affair, I first met Chuck Denham about 10 years ago, when he asked me to participate in a session that he was organizing for the National Patient Safety Foundation’s annual conference. The NPSF runs on a shoestring, yet I recall this session as being lavishly staged, our speeches accompanied by a video with Hollywood-like “production values.” I remember asking myself: Where did this person come from? And, more pointedly, where did his resources come from? I looked him up and learned that he ran an organization, called the Texas Medical Institute of Technology. I found precious little information about the Austin-based institute’s structure, staff, or history on the web, and Denham himself was based in Southern California. It all seemed a bit unusual, but not enough so to set off any alarms.

Over the next several years, I ran into Chuck at half a dozen safety meetings. I always found him enthusiastic, cordial, and highly (perhaps too highly?) complimentary of my work. He asked me to do a few things, including speaking in a couple of webinars staged by TMIT. These were quality events, well produced, and they gave me no reason to question his effectiveness or his motives.

Yet over the years, I found myself scratching my head about him on several occasions. A colleague visited him at his home in Laguna Niguel, an affluent beachfront LA suburb, and reported that it was palatial — not something commonly acquired on the salary of a former radiation oncologist. About five years ago, trying not to be too obvious, I asked Chuck where his money came from. He mentioned something about his wife’s family, and that he had decided to leave clinical practice to commit his life to patient safety.

On several occasions, he talked about his “research test bed,” saying, “We’re in more than half the hospitals in America.” It wasn’t entirely clear what this meant; having visited many hospitals over the years, I never heard of one that was using the services of TMIT, the way you hear about hospitals that work with Premier or the Advisory Board or the Governance Institute. Very little of this added up, yet still there was no smoking gun.

Over the past few years, I received at least five different calls from colleagues who had been approached by Chuck to work on one project or another — a video to improve radiology safety, an effort to reduce central line infections, and several others I can’t recall. In each case, the question posed by my colleagues was a version of, “Is this guy for real?” In each case I said the same thing: Yes, both he and the situation seem odd, and no, I don’t know where he gets his money. Yet he appeared to be a nice guy, good to his word, and he produced results. I told them that — despite my head scratching — I couldn’t think of a sound reason not to work with him. When I mentioned this to Peter Pronovost, the Johns Hopkins intensivist who is the world’s leading safety researcher, he told me, “It’s not that five people didn’t understand Chuck… I don’t know anyone who did understand.”

Things got odder still. Zelig-like, Chuck kept popping up in extraordinary places. After Dennis Quaid’s twin newborns nearly died of a heparin overdose at Cedars-Sinai Medical Center, I wondered whether Quaid would become a spokesperson for patient safety. The next thing I know, Quaid is holding a news conference, and standing beside him is Chuck Denham. And soon, a very slick video, Chasing Zero, was released and distributed gratis to hospitals everywhere. The producer: Chuck Denham.

And there’s more. The Journal of Patient Safety launched early in the safety field, co-sponsored by the National Patient Safety Foundation. To me, JPS has never been very good or particularly influential, and by all accounts it struggled to make ends meet. Then in 2011, I learned that it had named a new editor. You guessed it: Denham. The change had been made so precipitously that the NPSF, a founding sponsor, claimed it had been blindsided and removed its sponsorship in protest. I looked back to see whether Denham’s pedigree could justify his being named the editor of an academic journal. A PubMed search revealed that, before 2009, he had not had a single first-author publication in a 20-year career. Since then he has had 12, 11 of them in JPS.

Which brings us to the National Quality Forum. The NQF was founded in 1999 to vet and endorse quality measures. After the safety field launched, NQF added several safety-related products, most famously an NQF-endorsed list of “safe practices” and another of “serious reportable events,” the latter more commonly known as the “never events” list. Two individuals shared the job of chairing the NQF Safe Practices committee. One, Gregg Meyer, is a respected academician and safety leader, whose career has included stints at AHRQ, Mass General, and now Dartmouth. The other: Chuck Denham.

All of this is preamble to the announcement earlier this month that the U.S. Department of Justice had fined CareFusion, a manufacturer of safety-related products (market cap: $8.5 billion), $40 million for having given Chuck Denham’s company $11.6 million to try to influence the NQF’s endorsement of safety practices. It should be noted that, although Denham is specifically named in the Justice Department documents, no formal charges have been filed against him and both he and his attorney have denied that the payments were kickbacks designed to manipulate the NQF process. Denham’s statement, in which he calls the allegations “blatantly false,” is here.

The picture has become clearer with reports from several NQF insiders that Denham tried to change a general recommendation (in Safe Practice 22) to use a chlorhexidine-based cleanser for surgical or line-insertion site cleaning into one that specified a certain formulation, 2% chlorhexidine. Though committee members did not realize it at the time, such specificity would have been a home run for CareFusion, since its product ChloraPrep was the only one on the market containing that formulation. Several committee members, including Pronovost and Patrick Romano of UC Davis, have described being completely unaware of Denham’s CareFusion relationship. They also recalled becoming increasingly uncomfortable as Denham, on several occasions, lobbied for the 2% standard. The NQF meeting transcript, posted by ProPublica, shows Denham twice referencing a still-unpublished New England Journal of Medicine article that touted the effectiveness of the 2% formulation.

This is troubling on several levels. First, questions have been raised about potential conflicts in the NEJM article, since all of the study’s investigators received funding from Cardinal Health, CareFusion’s parent company. Second, there was no evidence, then and now, that the 2% formulation works any better than other chlorhexidine formulations. Finally, how did Denham, who was not an author, gain access to the NEJM findings prior to the paper’s publication?

Equally concerning, the NQF has also acknowledged that much of the staff work for the Safe Practices committee was supplied, gratis, by Denham’s company, Health Care Concepts. Denham was removed from his NQF position after concerns were raised by both staff and committee members, and a competitor, 3M, objected to the specific recommendation of the CareFusion product in the draft of Safe Practice 22. An ad hoc committee quickly convened by NQF reviewed the 2% recommendation and replaced it with a more generic one, although a different recommendation specifying ChloraPrep remained in place and Denham hosted webinars, under the NQF banner, that cited the CareFusion product as the one endorsed by NQF.

Several recent articles (in Modern Healthcare, WBUR’s CommonHealth blog, and ProPublica) have described the relationships between Denham’s companies and NQF in more detail; the chronology is well summarized by Roy Poses on his Health Care Renewal blog. Despite Denham’s protestation, I can’t come up with any other interpretation than that he was being paid by at least one company (CareFusion) to infiltrate at least one (NQF) and potentially other patient safety organizations (he also chaired an influential committee of the Leapfrog Group – he resigned from it recently — and has collaborated with the World Health Organization) and influence their work on behalf of corporate sponsors, while withholding information about these corporate links.

And CareFusion was far from TMIT’s only corporate partner. Here’s another, from TMIT’s website: “The documentary Surfing the Healthcare Tsunami: Bring Your Best Board was partially funded by General Electric Corporation and the Denham Family Fund with some in-kind support by HCC Corporation, an affiliate of TMIT that is a contractor to General Electric.” Interesting.

The NQF, whose CEO is now Dr. Chris Cassel, who was CEO at ABIM when I was board chair last year, has approached this scandal as a mortal threat, which of course it is. Cassel is relatively new to the NQF (Denham was long gone by the time she assumed her role) and she and her senior staff are in crisis mode, pledging to review all of the Safe Practices and to markedly strengthen their conflict-of-interest policies.

Cassel is not mincing words when she describes Denham: “He clearly lied,” she told Marshall Allen of ProPublica. “He just didn’t say anything about any of his business relationships.” According to the NQF, Denham was asked on several occasions about potential conflicts and never mentioned the multi-million dollar CareFusion contract.

It’s hard to protect our institutions completely against a lie. But in retrospect, all sorts of alarm bells should have gone off when it came to Chuck Denham. Who was this person, who seemingly came out of nowhere to a position atop the patient safety universe? Where did his resources come from? Why was he lobbying NQF for a particular product? Why was his company willing to donate what must have been hundreds of thousands of dollars of in-kind services to NQF? (According to ProPublica and confirmed by NQF, TMIT staffers conducted NQF evidence reviews and produced multimedia presentations on the Safe Practices.) “It was all a bit of a mystery to us that Chuck Denham was so generous with his time and his staff time to support this process,” Patrick Romano told ProPublica.

And I can’t help but wonder: What was the process by which the Journal of Patient Safety became yet another Denham franchise. To its credit, the journal has reportedly released Denham and installed the highly respected David Bates of Harvard as interim editor (he was associate editor). But the journal needs to go further, describing any financial relationship that might have existed between it and Denham or his companies.

What are the lessons from this sorry affair? For me, a personal one is to trust my spidey-sense: when something seems odd, nearly inexplicable, perhaps things really are not right. In Denham’s case, there’s a related lesson, reminiscent of a saying one frequently hears in Silicon Valley: if a product is being given to you for free, then there’s a good chance that you are the product.

Organizations like the NQF must have potent conflict-of-interest policies and enforce them strenuously. Though others may disagree, I don’t believe that individuals participating in such organizations need have absolutely no corporate ties — we’ll lose too many good people, and academic-industry partnerships can be good for patient safety. But these relationships have to be transparent and well structured. This means that the disclosure process must be rigorous and strictly enforced. Conflicts should be presented at the start of every committee meeting, and the culture has to be one in which individuals with even close call relationships err on the side of recusal, and colleagues feel comfortable “speaking up” when they’re concerned about potential conflicts. Would this have caught the Denham issue earlier? I’m not sure. But we must try.

As care standards increasingly drive payment and public reporting policies, and as electronic health records allow us to “hard wire” certain practice standards and monitor them in real time, the stakes will grow ever larger. Brian Johnson, publisher of Massdevice.com, told WBUR’s CommonHealth blog, “Large legal settlements involving kickback payments to doctors happen quite frequently. The Justice Department is very aggressive in prosecuting companies for kickbacks, off-label promotions, these types of alleged wrongdoings. This case is unique because in essence, it appears to be an attempt to influence an entire health care system by paying a key member of a very influential patient safety organization.” Such influence was never possible before. It is now.

This means that the fields of patient safety and quality are no longer sleepy mom-and-pop affairs fueled by the passion of a handful of true believers. There is now big money involved. “It’s an enormous business,” Pronovost told ProPublica’s Allen. “Hundreds of millions or billions of dollars are at stake, but our transparency procedures haven’t matured.” It is up to the field’s leaders to ensure that decisions are based on evidence, that our processes and structures are fair and transparent, and that individuals and organizations that violate the trust of our patients and clinicians are dealt with swiftly and sternly.

Bob Wachter is a professor of medicine, University of California, San Francisco. He coined the term “hospitalist” and is one of the nation’s leading experts in health care quality and patient safety. He is author of Understanding Patient Safety, Second Edition, and blogs at Wachter’s World, where this article originally appeared.

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  • Thomas D Guastavino

    Years ago, when the infamous “first do no harm” article appeared, claiming that health care was responsible for 100,00 needless deaths, it was obvious to many of us that the study was flawed. The failure of the article, and the subsequent media storm, was based on the fact that the article failed to make clear the distinction between an error and a complication. Errors can, theoretically at least, be reduced to zero, but complications cannot. Being the sheep that providers have always tended to be, this failure has led to numerous wrong turns and dead ends. The most recent has been the unbelievable and grossly insulting claim that the fee for service system is to blame because it encourages providers to CAUSE complications for financial gain.
    The only remaining question is whether or not providers will continue to be hand-wringing, mea culpa serving, sheep.

    • rbthe4th2

      While there is a difference between errors and complications, it doesn’t exclude the doctor who illegally retaliated against me for reporting a HIPAA violation, who didn’t know the evidence for a disease that was reported 3 years ago, for doctors following up dismissing patients because they couldn’t pay for a copay (when the doctor had no plan of care on record) … etc.

      http://health.usnews.com/health-news/best-hospitals/articles/2009/12/10/how-to-get-the-right-diagnosis-why-doctors-goof

      “While treatment mistakes like dispensing an overdose of medication are often caused by technical glitches, misdiagnoses are usually the result of flaws in a physician’s thinking,”

      “It’s not that a doctor lacks sufficient clinical knowledge—one study suggests that only 4 percent of misdiagnoses are caused by that—but rather is tripped up by his or her biases.”

      “Besides relying on first impressions, physicians often put too much stock in their past experience—overdiagnosing tumors, say, because they missed one once. Or, instead of trusting their instincts, they defer to a more experienced colleague or to the adage drummed into them as medical students: “When you hear hoofbeats, think horses, not zebras.” Result: They miss the zebra.”
      and my heart may be starting to go because doctors missed obvious signs, my liver because of signs that were ignored. Not all, but the current batch are a lot better than what I had.
      That also doesn’t account for blacklisting or cherry picking of patients. Or the rich ones who can pay concierge.
      Randy

  • Katooo

    ChloraPrep came on the seen so fast it was shocking. First the NEJM study is up against an iodine product NOT a gold standard CHG product. Plus the burn risk in the OR, plus it does not wash away dangerous transient bacteria (like a scrub does), plus it is not easy to apply and is done incorrectly by many. How did it get published in the NEJM??? This entire article may answer that. Always thought is was so odd to see that 2% recommendation….

  • guest

    Any reasonably savvy person would have been able to figure out that people who call themselves “Chuck” are suspect. But doctors are famously non-savvy, as they have spent their entire adolescence, and early adulthood studying to get into medical school and residency, and therefore have fairly stunted emotional IQs.

  • T H

    Denham should rightly be pilloried – perhaps literally – for this. CareFusion and its parent company got off lightly.

    Next: oncology, perhaps? How about orthopedic devices?

  • Dorothygreen

    A Bernie Madoff scandal in health care. This guy “chuck Denham” is (was) slick. I suppose a psychiatric practitioner – MD, PhD would say Wall street and healthcare corruption are
    not so different. Perhaps he would be given a label of sociopath.

    That seems to stream with the behavior of a person that can be so cunning, bold, charming, and personable who really does not give a hoot about, in this case “patient safety”.

    I checked out NQF t, knowing nothing before and could surmise how easily a “sociopathic parasitic”person could use NQF as a host. Lots of money there. Submit this or that, fudge some facts and Viola!, you have a grant or a product that out
    ranks all the rest – peer review and scrutiny be damned.

    It seems the US is so much more advanced in corruption – health care mega corps, finance and Big Food – leaders of the PACT – too big to fail and too big to jail. Fortunately, this guy was caught in the act like Bernie Madoff.

    Bravo to the Department of Justice.

    Now, perhaps this particular scandal did not raise my income tax but how can I be sure? I know I have to pay more to be healthy because healthy food is a specialty crop. Against my vote I subsidize that which clinical studies show cause the chronic preventable sickness of our society. My Medicare dollars are wasted on futile and painful end of life and those preventable chronic diseases.

    I am older, getting wiser and probably won’t live to see, the day the US has an affordable and universally accessible health care system with affordable, universally accessible healthy food.

    When and if that day comes there will probably be no need for me to spout on KevinMD, or will there be a need for organizations such as NQF.

    There will be bigger fish to fry.

  • drjoekosterich

    The quality and safety industry wants to make everyone else accountable but themselves. This is the same in Australia. I have no respect for those who expect others to do what they say not what they do.