Patient Safety’s First Scandal: The Sad Case of Chuck Denham, CareFusion, and the NQF

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, which broke two weeks ago, 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).

Screen Shot 2014-01-29 at 11.48.35 PMReturning 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 yesterday 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 lobbied the Safe Practices committee to insert a new recommendation to “use chlorhexidine gluconate 2% and isopropyl alcohol solution as skin antiseptic preparation…” (Safe Practice 22). 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. In addition, Denham changed a previous general recommendation to use chlorhexidine to prevent central line-associated blood stream infections (CLABSI, Safe Practice 21) into one that specified the ChloraPrep formulation. Several committee members, including Pronovost and Patrick Romano of UC Davis, have described being completely unaware of Denham’s CareFusion relationship. In the case of Safe Practice 22, 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 Health Care, 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 voted to replace it with a more generic one, which is what appeared in the final report. On the other hand, according to Romano, the 2% recommendation for CLABSI was not discussed in committee meetings, yet it did appear in the final report for Safe Practice 21. Moreover, 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 earlier today – 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.

80 Responses to “Patient Safety’s First Scandal: The Sad Case of Chuck Denham, CareFusion, and the NQF”

  1. Jim Conway January 30, 2014 at 2:17 pm #

    Bob, for anyone involved in the history of patient safety, and who over time included Chuck in a circle of friends, it is so difficult to read this comprehensive review of what’s known, and what’s being investigated as it relates to Chuck, his work, that of his company, and the impact. Thanks, as usual, for taking the time to lay the issues out so well. It raises lots of questions not only about practices overall but we individually could have made a difference in the story as it was being written.

    There is one area that I think we need to acknowledge much more than has been to date… the victims of medical error who were close to Chuck and TMIT. Chuck was one of the first and most visible leaders to surround himself with patients and family members struggling in the aftermath of great tragedy. He supported and advocated for them., telling the story of mothers, fathers, sisters, spouses and friends who were lost, devastated, abandoned, alone. There were videos, articles, meetings, workshops, webex’s, scholarships, and much more. There was a hug, and ear, and a place in his and the TMIT communities that didn’t exist in many other places.

    As all of this unfolds as it must, and we are faced again with seemingly endless tragic opportunities for learning and improvement, it is imperative that we intensify our support to the patients, family members, and friends, already victims, as well as staff, who may feel confused and victimized again. In studying serious adverse events, I’ve learned the key steps of empathy, support, assessment, apology, resolution, learning and improvement. No doubt they all apply here. Thanks again, Jim

    • Danny Long February 2, 2014 at 4:16 am #

      As you pointed out

      ” Chuck was one of the first and most visible leaders to surround himself with patients and family members struggling in the aftermath of great tragedy. He supported and advocated for them., telling the story of mothers, fathers, sisters, spouses and friends who were lost, devastated, abandoned, alone. There were videos, articles, meetings, workshops, webex’s, scholarships, and much more. There was a hug, and ear, and a place in his and the TMIT communities that didn’t exist in many other places”

      In retrospect, it sounds like Chuck figured out, and then polished “the perfect pitch”. It is bitter sweet to now know, and always question our own.

  2. Debra January 30, 2014 at 6:25 pm #

    I really hope that the Department of Justice brings criminal charges. To have used people’s most private and wrenching grief as a “product placement” is a terrible breach of trust and a grave violation of those who trusted him.

    What is missing from what Mr. Conway wrote is that the list also requires personal accountability. An apology is not enough. Restitution and personal consequences are. Until the medical profession stops believing that an apology makes it all go away, and supports justice for its victims, this is simply going to continue.

  3. Noel Eldridge January 30, 2014 at 7:19 pm #

    There were a lot of unusual things about interactions from Dr. Dunham, but at the time they seemed like mostly nice things. For example, I got a lovely Christmas card from him a few weeks ago. I think it was the only one I received at work. It would be terrific if he could somehow show all the work that his organization did in order to earn that $11.6M dollars. But I think that is unlikely to happen.

    I worked at the National Research Council for 5 years doing studies for NASA. (The NRC is the report-writing arm of the National Academy of Sciences and the National Academy of Engineering, and a sister organization to the IOM.) Before we started any committee members had to fill out detailed forms on their “potential conflicts of interest” and we had to have a discussion on the topic at the first meeting. The discussions were boring (the only funny or interesting thing I remember was a highly erudite and sophisticated former NASA Chief Scientist saying in a very deadpan manner that his investments were essentially several “money-losing” mutual funds), but they cleared the air. People explained who they worked for and what their investments were. If they worked for Boeing or had Lockheed stock after having retired from there they said so and other people on the committee and the staff kept it in mind and asked questions at this predetermined “safe” time to do so. Of course, people could lie I guess, and I imagine some did, but the session was written up and there would be no potential wiggle room for having made an honest mistake by not having mentioned some major conflict if the truth came out at a later date. I don’t know if NQF does something like this, but they probably should. Likewise Leapfrog, etc. I have to submit a form every year to state explicitly that I am not holding, nor buying and selling during the year, any healthcare related stocks, and list what I do own, etc., as a Federal employee at AHRQ, and previously at the Dept of VA. (And this is totally appropriate.) NQF might benefit from, if they have not already done it, putting all their processes for avoiding conflicts of interest from having an influence on their reports and recommendations.

  4. Lucian Leape January 30, 2014 at 7:34 pm #

    “To know Chuck is to be used”, I said some years ago to a colleague, but, I must confess, I thought generally in a good way. That is, Chuck was the master of “buttering up”, of flattery, of making you feel very special, if, often, as part of his “ask”, which was to participate, or be interviewed or filmed, as part of what seemed like worthy patient safety causes. In my case, for the Leapfrog Group, or the NQF, or his Discovery TV series. A bit too much of a hustler for my taste, but he understood the media world, which I didn’t, and was doing good things and giving patient safety greater visibility. Like Bob, I wondered where his TMIT got its money, but I didn’t think it was my business. And there was that business of his falling out with NPSF over ownership rights of a video or something that seemed more like a spat than a serious issue. Overall, just an unease about him, which I charged off to our being very different types of people.

    But my unease moved up a notch several years ago when a colleague suggested I re-view his Discovery program (I think it was). I did and found nestled in this hour-long program about advances in patient safety a 5 or 10 minute segment on “imaging” that seemed to have nothing to do with the narrative of the program. But I did note that it seemed to be all GE equipment and the light went on that perhaps Chuck worked for them. Not long afterward, he was made editor of the Journal of Patient Safety. I assumed it was a reward for his service over several years of producing essays for each issue that helped fill the pages of this struggling journal. I now wonder if there were other reasons. In any case, I decided to resign from the editorial board and distance myself from Chuck. It did not, however, occur to me that he might have reasons for trying to influence the NQF other than personal aggrandizement.

    But, as Jim Conway points out, Chuck Denham has also, more than any other leader in the patient safety community, stood by, listened to, comforted, and supported the victims of medical error tragedies. Whatever his motives, I will forever be grateful for his support of Julie Thao, the nurse at St. Mary’s Hospital in Milwaukee, who was fired by the hospital and indicted by the state for a fatal medication error that was clearly due to a host of systems failures. Not only did Chuck Denham give her verbal and emotional support, he helped her heal by giving her a job in which she shared her experience and participated in programs and courses to help others manage errors. He rescued her from the devastation and hopelessness she experienced in the aftermath of this tragedy and enabled her to rebuild her life. While a cynic might say it served his purposes, it certainly also served hers, and it was a generous and loving act that needs to be entered onto the balance sheet when judging the actions of this complex and troubling human being.

    Lucian Leape

    • Matt Scanlon February 20, 2014 at 3:26 am #

      A clarification and two brief anecdotes:
      1) The Julie Thao nightmare was at St. Mary’s in Madison, Wisconsin and not Milwaukee. If readers are unfamiliar with this, I would gladly share an article and three editorials written about the event.

      I would echo Lucian’s comments about Chuck Denham reaching out and potentially saving Miss Thao.

      2) As an occasional reviewer for The Journal of Patient Safety, I vividly remember the last article I reviewed at the request of Dr. Denham. A mediocre article, it featured Dr. Denham as Senior Author and the study was funded by his wife’s foundation. While I recommended rejection of the article for its lack of merit, I also pointed out the perceived conflict of interest having the Journal’s editor be a co-author, funded by his wife. As I said, this was the last time I was requested to review an article for JPS. A coincidence, I’m sure :)

      3) My late friend and mentor Dr. Ben-Tzion (Bentzi) Karsh was one of the smartest and most thoughtful safety scientists I had the privilege to know. The only time I saw Bentzi apoplectic was after attending a session chaired by Dr. Denham at the NPSF Annual meeting. Bentzi, a widely respected expert on human factors and patient safety, asked a question of Dr. Denham, in the process pointing out the lack of basis in both safety science and systems thinking of Denham’s comments. Dr. Denham dismissed him, saying something akin to “sit down young man, you don’t know what you’re talking about.”
      That event was sufficient for me to credit Dr. Denham for helping Julie while discrediting his mastery of safety science.

      • Michael Millenson February 20, 2014 at 2:10 pm #

        Matt: Those are quite disturbing insights on Chuck. Thanks for sharing.

        For more details on his finances, see the piece I posted on my Forbes.com page, “The Money, the MD and a $12 million Patient Safety Scandal. “http://www.forbes.com/sites/michaelmillenson/2014/02/14/the-money-the-md-and-a-12-million-patient-safety-scandal/

        Your comment reinforces my impression that in the woefully underfunded patient safety space, no one wanted to look a gift horse too closely in the mouth.

        Regards,
        Michael

  5. Michael Millenson January 30, 2014 at 9:13 pm #

    I’ve known Chuck (and Betsy) since 2000 and, like those above, have mixed feelings about this scandal. Chuck has been generous and supportive of many injured patients. He has been completely non-transparent about his source of income.

    Bob, to clarify: I don’t believe he claimed that TMIT was his source of income but, rather, it allegedly came from his for-profit company, HCC Corp, that was an incubator. His claims about it and its products are below from a bio; the website of the company itself does not even have an “About Us” section that lists staff or any other substantive information. Like you, Bob, I figured that if it was successful enough to generate millions in wealth as an incubator of small companies that I would eventually hear about some of those companies in the marketplace. I never did. Has anyone?

    It is, of course, not uncommon for those who own private companies to be very, very private on purpose and still be legitimately quite successful financially. Having said that, whether or not there is criminal conduct, there is no ethical explanation for Chuck’s undisclosed conflict of interest.

    Meanwhile, if you look at Chuck’s CV, almost all his publications are in the journal of which he is editor/prime financial supporter.

    Sad for all of us.

    Michael

    HCC has led, developed or supported 400 product development teams in more than 50 product categories, including pharmaceuticals, devices, capital equipment and Health Information Technologies. Its mission is to save lives, save money and create value in the communities and ventures it builds. HCC developed an evidence-based Breakthrough Technology Processing System now used for product contracting by one- third of U.S. hospitals purchasing more than $30 billion in products. HCC methods are used by global healthcare supplier and high-technology companies with more than $250 billion in revenues and more than 95% U.S. hospital market penetration. HCC accelerates market penetration of solutions that are evidence-based and patient- centered and that target systems performance improvement. The HCC accelerator incubates ventures spanning partnerships with global 10 companies to a portfolio of companies that HCC has spawned itself. The core values of HCC are integrity, compassion, accountability, reliability and entrepreneurship (ICARE). HCC is driven to exemplify these behaviors as a servant leader and to serve as a silent partner of healthcare innovators.

  6. bev M.D. January 30, 2014 at 10:30 pm #

    As a complete outsider to this situation, but one who keeps up with patient safety issues and subscribes to this blog, this tale is troubling on several counts. It sounds like Dr. Denham was the Bernie Madoff of patient safety, charming people and stringing them along skillfully to further his ends. But the picture of all those with whom he interacted as innocent dupes is a bit disingenuous. It is pretty shameful that all those organizations did not already have in place the precautions described by Noel Eldridge, especially in view of the recent scandals with Big Pharma and the known tendency of health care companies with an agenda to try paying people off. Just as in our diagnostic endeavors, a high index of suspicion is a necessary accompaniment to any association with companies and even individuals involved in health care these days. I hope those involved feel just a bit ashamed and determined to ensure this does not happen again. We can no longer hide behind the excuse of being naive do-gooders.

    care these days.

    • Michael Millenson January 31, 2014 at 1:16 am #

      Perversely, perhaps, I’m going to say a word in Chuck’s defense, Bev.

      I understand the Madoff analogy, but I think it doesn’t quite apply. I believe that Chuck was and is deeply committed to the patient safety agenda personally and professionally and to the patients whose lives he tried to help. By all appearances, he was a very smart and fanatically hard-working businessman who made a good profit from that work (not from being a radiation oncologist) years before CareFusion was a gleam in its founders’ eyes.

      But as those of us in this field know, patient safety and improving health care quality of care have not exactly been lucrative business niches. Perhaps, in the Great Recession, things changed for Chuck. Or perhaps there were other reasons.

      Yes, Chuck and Bernie both seemed utterly honest to their respective communities — that’s true. But Bernie was a case of greed (his job was making money) gone wrong. Chuck? We don’t know the answer, but what makes this case as much a cause for sadness as anger is the strong suspicion that the road to hell was paved with hard work and good intentions.

      • bev M.D. January 31, 2014 at 1:43 am #

        Michael;

        I understand what you are saying; perhaps it really is a story of a good guy gone wrong – although it seems he was always ‘private’ about his finances, so you never know what he was doing all along. But, I think the author and commenters are missing the point by concentrating on him. Perhaps they do so because they knew and like him and are wondering how they didn’t ‘know.’
        But, critically – there will be other Chuck Denhams, so the moral of the story is to put into place, stat, all the known protections that are already out there in other organizations, to protect the patient safety movement’s credibility (see the patient’s comment below) and to protect patients. That’s why we’re all here, after all.

    • Noel Eldridge January 31, 2014 at 2:48 am #

      I agree re Madoff. Denham hasn’t been convicted of anything. The situation doesn’t pass “the smell test” and it “quacks like a duck”‘ etc., but that’s a long way from being convicted of swindling people out of many millions of dollars.

      I had forgotten the GE imaging thing that Dr. Leape mentions being in a documentary, but it was so obviously akin to a product placement (at least the way I remember it) that I remember thinking to myself that it seemed like an obvious quid pro quo in what was a sort of commercial product (the documentary). But the chloraprep thing seems totally different – the sponsorship, unlike GE’s, was apparently secret, and not a known conflict. Writing about and discussing recommended Safe Practices in an obscure meeting room is not like making a tv show that is intended to make the topic of patient safety interesting to the public…

  7. Debra January 31, 2014 at 12:57 am #

    Dr. Leape, I must say your comments are very disturbing. I don’t how understand coming to the defense of Ms. Thao is a positive. What she did was negligent and she was rightfully condemned by the medical community. The root cause of patient harm is the persistent normalization of deviant behavior. The “systems” we have are no more than people, and the “system” never works. What we need is for people to choose to be responsible. Your defense of Ms. Thao as well as Mr. Denham’s is an insult to all of us who have suffered harm. You need to be on our side, not the side of those who choose to disregard their responsibilities.

    As for Denham’s supposed singular kindness to harmed patients, it seems to me to be a rather stinging indictment of the medical community that the only succor harmed patients find is with those who wish to exploit their tragedies. It is most certainly not an excuse for Denham’s conduct, which is loathesome.

    It seems to me that this whole excursion raises some very serious issues. Can the medical community really be trusted with patient safety or must it be given to non-medical people because the medical community cannot self-police? Why is it that even those who advocate for patient safety were unable to act on suspicions of misconduct with very obvious red flags? Why is the medical community Why is the medical community bereft of empathy for those it harms? What other organizations are similarly vulnerable to this kind of misuse– certainly the Joint Commission is, to its eyeballs. Yet, the Joint Commission is permitted to enforce federal law with exactly zero public oversight. Is it not time to call for the Joint Commission’s records to be open. How about other organizations who act in an oversight role with public charters or public funds How do we know they are not being gamed either?

    My health and safety should not be put at risk because doctors and nurses are afraid to call out their colleagues. This is a good opportunity to show some leadership on that and have the medical community hold Denham to account. If the medical community does not, it only underlines to patients that we are on our own here, that when push comes to shove, the medical community cares more about making nice with each other than our well being.

    Dr. Leape, with all respect, your comments are chilling to me as a patient. We need the leaders in the patient safety movement to stop being apologists for reprehensible conduct.

    • Suzanne Gordon February 6, 2014 at 7:12 pm #

      The role Chuck Denham played in the Julie Thao case should be noted on the positive side of any ledger. The case was very complicated and it is a shame a patient like Debra should view it as anything less. As I wrote in an op-ed at the time, Thao was not a bad apple but was clearly working in a very bad system in which nurses were encouraged — even publicly applauded — for working vast amounts of overtime that made them a danger to patients. Thao was strung out to dry by her hospital while system issues were not addressed. Moreover, the fact that the state pursued felony charges against her for what was clearly an unintential error was what was really chilling. If people who make unintentional errors, when their hospitals encourage them to work dangerous hours, are brought up on felony charges, who will ever report mistakes, near misses or other problems that need to be publicly acknowledged and addressed if we are to advance patient safety?

    • Beth Boynton, RN, MS February 6, 2014 at 7:41 pm #

      Hi Debra,

      I can understand why you would be disturbed and yet agree with Dr. Leape and Suzanne Gordon response. It may seem like an obvious act of negligence on the part of Ms. Thaos from the outside looking in, but for those of us who work in or have worked in HC systems, it is more complicated than that.

      ‘Systems’ and the people in them are interrelated for sure, but there are power gradients at work that are very complicated. Consumers who want to use their power to change this system must be responsible too, for understanding the underlying dynamics. If speaking up were simple, we’d have solved the issue long ago, but it isn’t.

      When “we” work in systems that don’t support the work in terms of staffing, time, and resources to do things right, and make efforts to request support that are ignored or devalued, we have to find the safest ways to do them wrong. Add this to blaming cultures and there is a sad recipe for trouble. I’m not saying this is good, I am saying it is a reality in some organizations. Talking about such things openly is not safe.

      Please consider learning more about the dynamics going on and how consumers can help advocate for more resources to ensure professionals are supported.

      Shortcuts in Medication Administration: Why Do We Do It Wrong If We Know How to Do It Right? (and We Do!)
      http://www.confidentvoices.com/2013/02/04/shortcuts-in-medication-administration-dangers-of-normalizing-deviance-keys-to-preventing-errors/

  8. Patrice Spath January 31, 2014 at 1:39 am #

    I am deeply saddened that media attention on this incident could taint all the fine work done by the many people who selflessly devote their time and expertise to improving patient safety. I agree with Dr. Wachter that we should not “exclude” people with business ties — as often their perspective is very valuable.However, transparency is critical!

    So often I’ve heard Dr. Leape quoted as saying, “99.9% of the people are good people trying to do the right thing” (the “good” apples). Thankfully 99.9% of the people involved in the patient safety movement are virtuous. We should not let a “bad apple” upset our momentum.

    Patrice

  9. Paul Levy January 31, 2014 at 1:49 am #

    An excellent summation by Bob, and also very thoughtful comments by all the others. Bev’s are particularly incisive: Patient safety and quality organizations have come to have greater influence, which is good, but that also makes them vulnerable to financial and other conflicts of interest, plus the potential of being used by members of the medical-industrial complex. They must put governance procedures in place to try to obviate the likelihood of this kind of thing happening. Even then, though, the job is not over–as governing bodies must also act to ensure compliance with their own rules.

    The stories told by Jim and Lucian about the kindness shown by Chuck to patients are striking. Not that I am suggesting forgiveness where it is not deserved, but let’s remember that people are not uni-dimensional. The good deeds live on in people’s private lives and carry inherent worth, even as other less positive aspects remain in the public record.

    I may be in the minority, but I wish for Chuck some kind of peace as he goes through the hell of these revelations, for he must know that his effectiveness in helping to carry out good for the public and individuals is (probably) irrevocably impaired. Is it possible, as Jim notes, for him and us to go through the steps of empathy, support, assessment, apology, resolution, learning and improvement? We do so for doctors who have actually killed and maimed patients. Can we here? Or do we simply judge and fail to complete the healing and learning process?

  10. Matthias Maiwald January 31, 2014 at 5:22 am #

    Colleagues and I have pointed out (and published) for quite a while that there is something ‘fishy’ about the chlorhexidine story.

    We looked at a different aspect, the widespread misattribution of clinical trial outcomes from a combination of chlorhexidine and alcohol (i.e. two antiseptics) when tested against single-antiseptic competitors.

    Whether and in what way this misattribution or misconception has also been commercially influenced is something that I do not know.

    Nevertheless, it is clear that the often-proclaimed “evidence for chlorhexidine in skin antisepsis” is not what it often is purported to be.

    See:

    Maiwald M, Widmer AF, Rotter ML. Lack of evidence for attributing chlorhexidine as the main active ingredient in skin antiseptics preventing surgical site infections. Infect Control Hosp Epidemiol. 2011 Apr;32(4):404-5. doi: 10.1086/659253

    Maiwald M, Chan ESY (2012) The Forgotten Role of Alcohol: A Systematic Review and Meta-Analysis of the Clinical Efficacy and Perceived Role of Chlorhexidine in Skin Antisepsis. PLoS ONE 7(9): e44277.
    http://dx.plos.org/10.1371/journal.pone.0044277

    (For a quick glimpse, see the conclusions section of the abstract).

    Maiwald M. Why evidence should have biological plausibility: the story of chlorhexidine and its role in skin antisepsis. Teleclass, February 7, 2013. http://webbertraining.com/recordingslibraryc4.php.

    Maiwald M, Petney TN, Assam PN, Chan ES. Use of Statistics as Another Factor Leading to an Overestimation of Chlorhexidine’s Role in Skin Antisepsis. Infect Control Hosp Epidemiol. 2013 Aug;34(8):872-3. doi: 10.1086/671282
    http://dx.doi.org/10.1086/671282

  11. Marty Hatlie January 31, 2014 at 5:25 am #

    I don’t see the Denham event as the first scandal in patient safety. Nor is he the first tragic human player if you count the guy who falsified his resume across at least two continents that I know of, maybe more. Top of list for me are the systemic scandals too many people still turn our heads from to often. Quiet dismissals of problem docs from medical staffs into the wild blue yonder when our consciences know these people are very likely to cause more harm in other communities. Expert witnesses in malpractice cases who still say what they are paid to say, even about causation. Too many hospitals with disclosure policies on the books that they do not follow. Disparity gaps in outcomes between the haves and have nots that are not closing. Hopefully Obamacare will make a difference on the last issue, maybe others on my list.

    The takeaway for me from this event is systemic — to make sure every organization I have a say in reviews its COI policy and gets a best practice one in place as well as a values statement that trumpets transparency and stays a conscious part of day to day behavior. I have work to do on these fronts. I agree with Noel that people will lie, but think a public pledge of transparency would at least allow organizations in NQF’s position in 2010 to state more publicly that we ended a relationship because of differences in values rather than proceed in conscience-disturbing silence.

    • Noel Eldridge February 2, 2014 at 3:55 am #

      I’m glad Marty made this point. The other day I spent an hour or more ruminating on the idea that this definitely wasn’t the first scandal, and what I wanted to say about that, but when I came back Marty had made his excellent points. I’m sure some people see patient safety “scandals” as a daily occurrence, and it would be hard to argue with that point of view. But I think this is the first blatant “professional-payoff-corruption-fraud”-type scandal that I know of. If it is as it seems to be, it goes beyond anything I know of along the lines of conflicted members on committees writing guidelines as was apparently the case a few years ago on the topic of DVT prevention, and I guess has also been the case, as Dr. Fairbank suggests, for other situations.

  12. David Marx January 31, 2014 at 3:17 pm #

    One bribe begets another.

    I was struck by the DOJ’s press release stating they have allowed CareFusion to pay our government $40.1 million to “resolve allegations” that they took a bribe. The DOJ offered us not one person at CareFusion who authorized the bribe – only a faceless company who was able to convince our government to go quietly away. It looks like one bribe followed another.

    I have known Chuck Denham for over 10 years. He has been a tireless supporter of patient safety. If he has done as alleged, he should stand to account for his choices, as should the leadership at CareFusion who paid out that 11 million dollars.

    In this case, our highest enforcement agency in the land issued a press release, and then walked off the job with their 40 million dollar bribe. As they walked, they put Justice in the court of public opinion. It worked out well for CareFusion – not a single human being accused of wrongdoing.

    If the enquiry stops here, we have perpetrated an injustice. Let Chuck have his day in court. Pray for him and his family. Whether guilty or not, he is a fellow member of humanity, sharing with us a common fallibility, and a common “free will” that sometimes leads even well-meaning humans astray.

    We all have to account for our choices – if Chuck Denham and the CareFusion executives did as accused, they must be held to account. We should not let the DOJ simply claim another enforcement success when they walked off the job halfway through their task.

    • Noel Eldridge February 2, 2014 at 4:56 am #

      I agree with this point. I was going thru some notes from 2006 and 2007 and realized that at that time it seemed like a pretty widespread opinion that the Chloraprep surgical skin prep was potentially a great product. I think it was the only one with both alcohol and CHG. The concept was that alcohol is very effective for immediately killing most microorganisms on skin before surgery, and that CHG would supply the “persistent activity” that was and is, I think still, considered important in applications where bacterial regrowth after skin decontamination is a concern (as in on a surgeon’s skin inside of surgical gloves that become damp as his or her hands sweat inside the gloves).

      My point that generally thinking that Chloraprep was a very good product, and saying so, at some point in time, is not proof of anything. On the other hand, if this opinion was expressed doggedly in high-level committee meetings, and combined with having taken $11.6M and not having delivered any product or service that is demonstrably worth anything close to this amount of money, it seems that it would not be too tough to convince a jury that the $11.6M was a bribe. It would be ugly I guess, other committee members would have to testify in court as to what they remember of CD’s behavior at the meetings, etc., and people at Chloraprep would be put on the spot to explain what they thought they were buying (if not influence), but isn’t that as it should be if we are to conclude that he is a crook?

  13. Ross Koppel February 1, 2014 at 5:50 pm #

    Thanks to Bob and the others for this important discussion. I don’t know Denham, but I assume he’s a complex human with many faults, just like the rest of us. Alas, some of his faults are more consequential than most of our because of his and his backers’ power to influence various organizations and their misuse of those organizations (e.g., 11 of his 12 first author pubs in his “own” journal; pushing meds/practices sans good evidence). This does neither negates nor diminishes his noble deeds,
    What concerns me is his role in influencing NQF’s and NPSF’ unrelenting advocacy of healthcare IT. I’ve long been concerned about their implicit algorithm that more HIT = more patient safety. Such syllogisms are understandable (though still deeply misguided) by HIMSS or the EHRA.
    There are many extraordinary benefits of HIT; but the debate should not be one-sided; and one expected more from NQF and NPSF. Let us hope they are now less entangled with industry and more able to allow a nuanced analysis of patient safety needs.

  14. David Roberson February 1, 2014 at 10:11 pm #

    If a single human error or malfeasance leads to patient harm, then we all believe that this implies that the system in which that error occurred was flawed, and that we should focus on the system not the single human error.

    If the system of disclosure has no means to determine if financial disclosures are flat-out lies except for all of us to trust our “spidey-sense,” then the disclosure system is flawed.

    With great respect, I don’t believe anything suggested in this discussion so far provides a reasonable safeguard for the next smooth-talking dishonest person. Dishonest people, after all, are usually good at concealing their dishonesty. If they lie on disclosure forms then they will be careful not to reveal those lies elsewhere. If anything, it sounds like Denham was on the careless end of the spectrum. Had he been more careful, he might still be in business.

    I see no option except for participants on high level panels of this sort to provide their income tax returns, preferably to some blind third party, for review. It’s lovely to think we can all trust each other, and I do trust many of the people who have responded to this thread. The reality, however, is that history is replete with examples of apparently trustworthy people who fooled very smart people. Bernie Madoff may not be a good comparison to Denham from an ethical point of view, but he was able to fool hundreds of extremely smart billionaires. Do we really think that we in patient safety would be able to detect a liar of Madoff’s caliber before he (or she) did a world of harm?

  15. Terry Fairbanks February 2, 2014 at 2:33 am #

    Thank you for writing about this Bob. I also enjoyed reading the insightful responses, many of which I agree with, especially along the lines of this not being the first scandal in patient safety (and good point Marty- I know who you mean). But there is one issue that I’m surprised has not yet been mentioned: the many cases of COI that have been cited in the development of clinical guidelines over the years. Although clinical guidelines can be controversial, I think we can all agree that when done right (and based on true evidence), they could be a good tool in patient safety (and they’ve been around since before patient safety was called patient safety). But they are dangerous if bias isn’t controlled, because they often lead to rules about payment, quality measures, health IT decision support (and meaningful use criteria?), and sometimes impact tort.

    I don’t profess expertise in clinical guidelines, but I do see the need as I find myself regularly surprised by how much variation there is in care across the US, even in cases where there is good evidence to suggest that there is a best practice. When I’m working in the ED I still routinely see patients who have been put on unindicated antibiotics by other doctors, despite widespread knowledge about the epidemic of resistance (young healthy non-smokers with a viral syndrome being put on abx for “bronchitis” is my favorite). Recently when a patient requested I transfer her to her preferred hospital for her routine asthma exacerbation, the receiving doctor asked me why I hadn’t obtained an ABG (one was not indicated in this case and would not have changed management), and she told me that they get ABGs on all their asthma admits (hadn’t this been worked out years ago?).

    But I digressed. Back to my point: There have been many reports over the years of guidelines that were influenced by financial conflicts of interest and by stacking the panel with single points of view. A recent article by the Guideline Panel Review Working Group summarizes the problem well, and describes problems with current guidelines and lists red flags for bias in guidelines. (Lenzer J et al, Br Med J 347:f5535, Sept2013). A survey of guideline developers reported that nearly nine out of ten have largely unreported financial ties to industry. One report showed that panels had up to 80% of members influenced by companies which stood to have direct gain from the guidelines that were produced; See also Johnson L, et al, J Med Ethics 35:283, May 2009; Norris, Holmer, et al, Conflict of Interest in Clinical Practice Guideline Development: A Systematic Review, PLoS ONE 6:10; Eichacker, P.Q., et al, N Engl J Med 355(16):1640, October 19, 2006). The list goes on and on.

    I’ve never written about the conflict of interest issues around clinical guidelines before, but it has always bothered me enough that I have trouble knowing which guidelines to trust. I believe that we cannot have a discussion about conflict of interest scandals in safety without talking about the development of clinical guidelines.

    Finally, I want to say to Debra that I hear your pain, and I understand your anger, and I recognize that although nothing will repair the devastation caused to you and other families that have felt the impact of medical error on a loved one. But we have to become safer as an industry, and we’re not doing it by closing cases by blaming the people who were on the front line when the error occurred. The systems approach to which Lucian bases his position on is not about a lack of accountability. This isn’t about protectivism, but because of two main principles: 1. human error will always be repeated by others, so the only way to create sustainable safety improvements is to design system improvements that mitigate the harm or prevent future similar errors; and 2. There are hundreds of near misses for every patient harmed, so in the right environment and safety culture we have an opportunity to learn about (and mitigate) unsafe conditions BEFORE they cause harm, but we create blame environments then we scare our frontline providers- those who know where our vulnerabilities are- into silence. We have to follow the lead of of other safety critical industries which have figured it out. In the 1940s, airplane crashes were almost always blamed on “pilot error” and cases closed. Today, aviation has institutionalized the protection of those who report errors, and has become incredibly safe—we almost never crash planes, despite regular pilot error. Healthcare needs to get there. I think that this is what Lucian is saying. Blaming it on the system does not take any accountability from us as an industry, it just helps us focus our efforts in the place that can give us sustainable and effective solutions.

    @TerryFairbanks

  16. Noel Eldridge February 2, 2014 at 3:45 am #

    This may be the best discussion of patient safety issues of its type – with ad hoc inputs from so many people who have tried to address patient safety problems for so many years – that I’ve ever seen.

    • Bryan Bagdasian February 3, 2014 at 2:55 pm #

      Agree. Now, let’s create sustainable and effective solutions.

  17. lars aanning February 2, 2014 at 6:30 am #

    Airline pilots are forced to undergo periodic testing in simulated catastrophic situations – both to test their skills in damage control but also to observe the way they deal with crises. Imagine if a pilot need only pass a multiple choice test every ten years, attend several CME courses at resorts or on cruises, and buy malpractice insurance from a carrier “owned” by his colleagues in order to be licensed, certified, and entrusted with people’s lives? Chlorhexidine surgical prep? Really? Yes, that’s where the money was…

  18. James Padilla February 2, 2014 at 2:02 pm #

    If this is true, he is not the only one in Patient Safety driven by a desire for generating personal revenue. Many so-called “experts” sell their services and their organization’s status for personal gain and recognition. A sad reality of patient safety!

  19. Bob Wears February 2, 2014 at 7:19 pm #

    There’s an issue in this scandal that has not yet been discussed. it is a ‘structural’ problem, which means that episodes like this are likely to be repeated unless we can deal with it. That issue is the concentration of power. When any single organisation, no matter how pure its people and motives, winds up in a position to swing thousands of economic decisions, the temptation to resort to unsavoury means of influencing it will become overwhelming, and eventually someone will succumb. Better people and more stringent COI requirements will not change that ultimate reality.

    This issue is of course not limited to patient safety; it certainly played a role in the financial collapse that led to the Great Recession, among other things. We need to think carefully about to avoid, even dismantle, these concentrations in favour of a more distributed, polycentric mode of supervisory control. It may be more complicated and less efficient, but in the long run will be safer.

    • Suzanne Gordon February 6, 2014 at 7:38 pm #

      Bob Wears makes a really important comment here when he highlights the structural issues involved in this case. Reading it, I keep wondering why we are so surprised by this development. The patient safety movement operates in, not outside of, a wider culture that has always been –and has become even more obsessed — by individual advancement, celebrity, greed, and the marketplace — as in the selling of everything from inanimate objects to critical aspects of individual and social interaction. Reading the details that we know about this scandal reminds me of the book Jerry Kassirer wrote a number of years ago. In his excellent book On the Take he detailed the influence of Big Pharma on medicine. Is it surprising that some patient safety physicians would also be on the take when so many of their colleagues in medicine are too? (Nursing, by the way, likes to think of itself as exempt from this but sadly, it’s not). When that seems to be the norm rather than the exception? Reading Bob’s (Wachter’s) analysis of this scandal I am also reminded of recent articles in the New York Times exposing the practice of a hospital that tried to fire ER docs who wouldn’t admit patients to the hospital despite the fact that they didn’t need hospitalization (http://www.nytimes.com/2014/01/24/business/hospital-chain-said-to-scheme-to-inflate-bills.html?_r=00) or dermatologists who charge $25,000 for removing a tiny basal cell carcinoma (http://www.nytimes.com/2014/01/19/health/patients-costs-skyrocket-specialists-incomes-soar.html)
      We, as a society, have not resolved how we define the goal of medicine. It is all well and good for physicians, nurses, and others to insist that they are patient-centered. The facts, however, are unarguable. In the market dominated US healthcare system, there seems to be a lot of confusion about the goals of medicine. Too many health care professionals and administrators seem to believe that they are entitled to do more than make a good living but rather are entitled to make a killing. That making a killing in the metaphoric sense may lead to patients dying quite literally is all too often ignored.

      What is tragic about this incident is that shakes patients’ and the public’s credibility in a movement — the patient safety movement — that should have our unshakable support. When I read Jerry Kassirer’s book, and other work on the influence of Big Pharma on physician treatment and prescribing patterns, I came away wondering whom I could trust? I even worried about the judgment of my wonderful PCP — someone whom I doubt would be influenced by drug detail men. He, after all, was reading the same studies everyone else was and how many of these studies were subtly or not so subtly influenced by Big Pharma. Now we find that some physicians in the patient safety movement are similarly influenced by similar ties. This is, to put it mildly, not good at all. The discussion begun here must be extended in ways that may be very uncomfortable but must nonetheless be not only approached but embraced.

  20. Debra February 3, 2014 at 3:36 am #

    Terry, not all problems are systemic. Some problems are a result of people taking advantage of situations and other result of people who don’t care about others. When a pilot shows up drunk for a flight, he’s relieved and there is no long and drawn out discussions of what noble acts he has done in the past, how good his intentions are, or how misguided he might have been by circumstances in his personal life. The first and pretty much only concern is that of the flying public. And that means he or she is not flying a 747. Period.

    Both David and Terry, I used to be part of the missile community. Some problems are system issues, process issues, equipment issues, design issues or engineering issues. But not all problems are system issues and one will minimize system issues when you properly manage people and enforce conduct that conforms to expected norms. Some people issues are leadership, but sometimes people ARE the problem, period, because they refuse to conform the the requirements. Systems are ultimately made up of people and if there are people who are greedy, or sloppy or not competent, the solution to that problem is removal of the person. Leadership means making those decisions. And that doesn’t happen because doctors in particular refuse to hold their colleagues to account when needed. Patient safety is not going to improve until that happens or until oversight is removed from the medical community. Some problems are not kumbayaed away. And with the massive death toll from medical errors, whether 99.9 mean well or not is irrelevant, and its pretty obvious that 99.9 percent are competent. I think Dr. Leape grossly soft-sells the problem, to the detriment of fixing it.

    That medical providers will remain silent unless there is immunity to me just demonstrates how morally bankrupt the medical profession is. Would you seriously believe your ten year old tell you that he can’t be held responsible for breaking your neighbor’s window because otherwise he would lie to you? Seriously, you would send his to his room in addition to paying for the window for that kind of blackmail reasoning. Why should we the public accept moral standards from people we trust with our lives that are less than we expect of grade school children. Your argument, to me, simply acknowledges that the entire medical profession is corrupt. People who will do the right thing only if it is easy, seem to me to be not qualified to practice medicine, just on that score. Am I really to trust my health to someone so craven?

    Again, go through the comments and look at how they skew. The line of those trying to say that Denham was still “noble” and meant well, with no serious empathy for the families who allowed their most painful moments to be used by Denham, not for the purpose of making things better, but rather as product placement. He used these people, absolutely cynically. And the real moral of this story is the inability of the medical profession itself to remove someone who is doing harm to patients and their families, and as seen in the comments above, the need of the medical profession to “spin” the events in something more benign. Where are the “prayers” for the downtrodden in this story — the families who have been used to given this guy the guise of credibility?

    And finally, NQF is a government contractor. That is why DOJ is involved. The government requires affirmative disclosures in this sort of situation and lying on those forms is a crime. If we do not enforce those laws, why would anyone be truthful – and in fact, its pretty clear in medicine they are not. The medical community is not the only ones at the table. The magicful thinking of no consequences, I just say I’m sorry and everything is ok is magical indeed and not something that the rest of us in society necessarily agree with.

    • Paul Levy February 3, 2014 at 12:52 pm #

      Oh my gosh, Debra, you hit home with this in a way I hadn’t considered. Thank you. I’ve just imported your lesson to an ongoing conflict-of-interest situation at the University of Illinois. Take a look. It is happening right in front of our eyes, and the governing body of the University is standing by and doing nothing:

      http://runningahospital.blogspot.com/2014/02/when-doctors-refuse-to-hold-their.html

    • Bob Wears February 5, 2014 at 2:33 am #

      Ultimately, even ‘people’ problems are system problems. Somehow, those bad people got in positions of power and responsibility. Somehow, their malfeasance went undetected, unreported, and unchecked. Those are systems issues.

      This doesn’t excuse the malfeasance, or brush personal accountability under the rug, but rather points out that real systems thinking — not the systems rhetoric that is bruited about in safety meetings — still has yet to be applied.

      To focus on ‘bad people’ allows the defective system to continue on its merry way, unperturbed.

  21. Ilene February 3, 2014 at 4:18 am #

    Although I did not want to comment, I feel compelled to. Dr. Denham was not the first person to take medical injury survivors under his wing. NPSF was doing this long before he was out there. The big difference is no “one” person at NPSF was a “star” for doing so. Marty Hatlie welcomed a group of medical injury survivors to the AMA in the mid 90′s that began a conversation between patients and providers. Given the money we are talking about that Dr. Denham received, which of us, if given that kind of money wouldn’t use it to move forward the patient safety movement so we too could help this army?

    I think in a patient safety world where disclosure, respect and honesty is paramount to move us forward, we would all do well with a statement from Dr. Denham, truth in what happened, sympathy for him and his family and we all move on. Anything less I fear has set us back 20 years. This has been nothing but an uphill battle and in my 18 years leading a grassroots patient safety group, there has been other things holding us back – this should not be one of them.

  22. Fred Goldstein February 3, 2014 at 9:40 pm #

    Unfortunately, we can put in place all of the systems and controls we want but as we’ve learned with hackers, swindlers and liars, someone will find a way. The underlying issues – there is just too much money and too little accountability. Health care in the US is a giant trough and the only one, that if it feels constrained and those feeding from it feel the need for more, they just grow it larger, consuming ever more of our GDP. I wrote about these issues in 2006 and sadly only the names have changed and perhaps a few unlisted segments of the industry have been added…

    http://www.pnhp.org/news/2006/april/the-word-of-those-with-whom-we-do-business-the-state-of-ethics-in-healthcare

    Holding people, not corporations accountable would be a good first step.

  23. Beth Boynton, RN, MS February 4, 2014 at 10:27 pm #

    We need a single-payer system to get focused on the right priorities; “Health” and “Care”. As disturbing as this scandal is, it is not surprising. We need to be able to trust ourselves and each other to do the “right” thing. But there are many mixed messages about what the ‘right’ thing is. We make decisions every day to provide or limit care b/c of $$$. We need and often do not have enough staff, time, supplies to do things right, but it really isn’t always safe to speak up about things people in power don’t want to hear. If Dr. Watcher is reluctant to speak up to a peer, imagine the invisible pressure nurses and patients feel.

  24. Rory Jaffe February 5, 2014 at 10:48 pm #

    Conflicts of interest are pernicious, in that very bad things can happen even without overt intent. I’m not sure that Chuck Denham meant to do the wrong thing, but he ended up doing something that was very wrong.

    I’ve met with him several times, and was impressed by several things: 1) He cared passionately about patient safety, about ensuring that the patient was front and center in every effort, and that caregivers who made mistakes were properly supported. 2) He has been a serial entrepreneur in multiple industries (e.g., aviation, health care) and very business savvy, 3) He believed he was doing good work–ethical works.

    Those very traits could lead to thinking that he was better than most; could manage the inevitable conflicts of interest that arise (as health care and industry are inextricably intertwined); and that his acts (e.g., recommending ChloraPrep) were completely logical and unaffected by his interests. Well, psychology has shown quite the opposite, that individuals are extremely poor judges of their objectivity, and that what a person believes is a logical decision is frequently made contrary to that which logic would demand.

    This event reminds us all that we should review our conflict of interest policies; particularly the parts regarding indirect financial interests (e.g., Chuck was an officer in a company that did business with CareFusion–Chuck didn’t receive the money directly but certainly had a financial interest). It is important to provide clear guidance on these indirect interests, as individuals are highly unlikely, on their own, to recognize these as an issue.

    This whole episode is very sad and should remind ourselves something which we face every day in patient safety–each of us is very human and very fallible.

    • Beth Boynton, RN, MS February 5, 2014 at 11:14 pm #

      I agree that it is very sad and we are all human and make mistakes. It seems like Dr. Denham benefited (up until recently) from his while many may have suffered. Doesn’t it seem like there is a difference between this and the kind of mistakes we make as HC professionals in the course of doing our work? For me it raises the question of any fortune making in heathcare as a fundamental concern b/c it is directly or indirectly a result of others’ misfortune.

      I think he must be accountable too and perhaps other healthcare leaders can review their own associations with his lessons in mind. Wendell Potter, the former VP of Cigna is my hero in his own awakening and stepping down from his well-paying job as communications VP. His story is depicted in his book, “Deadly Spin” and briefly in the movie “escape fire”. (If interested here’s a review post: http://mkt.medline.com/clinical-blog/acute-care/escape-fire-movie-sparks-hope-for-damaged-u-s-health-care/).

      • Rory Jaffe February 5, 2014 at 11:43 pm #

        “Doesn’t it seem like there is a difference between this and the kind of mistakes we make as HC professionals in the course of doing our work?”

        We don’t yet know. That’s the point I was trying to make. Conflicts of interest are bad regardless of intent; and need to be managed regardless of intent. James Reason’s algorithm for assessing responsibility could be used in this case just as it can be used in health care.

        By assuming that conflicts of interest are only a problem when people are “bad” will blind us to the reality that biased decisionmaking occurs very frequently, and we need to always guard against conflicts of interest, even when we are dealing with highly ethical people.

        Conflicts have been a particular interest of mine–there’s more discussion on this in http://senate.universityofcalifornia.edu/underreview/Proposed.pharmaceutical.policies.0107.pdf , which eventually resulted in a zero-dollar gift limit for the university health professions schools and personnel.

        • Rory Jaffe February 6, 2014 at 12:05 am #

          Even better, here’s the final policy adopted by the University of California. Note the FAQs, which discuss some of the issues involved. http://policy.ucop.edu/doc/5000433/HealthVendorRelations

        • Beth Boynton, RN, MS February 6, 2014 at 12:08 am #

          Thanks, Rory, that’s helpful. I do get your point and in general agree with you that conflicts of interest are bad. And the link you offered is a great example of working to minimize/eliminate them.

          The main point I am trying to make is that this IS one of the fundamental problems we have in USA healthcare, i.e. there is a conflict of interest between making excessive amounts money and being in healthcare.

  25. Paul Levy February 6, 2014 at 12:59 am #

    This has been a terrific discussion. Thanks to Bob and all who made it possible.

    But there is one bit of unfinished business, the extensive CareFusion product placements in the Chasing Zero video. Please read more here: http://runningahospital.blogspot.com/2014/02/product-placement-on-steroids.html

  26. Noel Eldridge February 11, 2014 at 2:40 am #

    The TMIT webinars are still going… Today I got an email notification for this one… http://www.safetyleaders.org/webinars/indexWebinar_February2014.jsp

  27. menoalittle February 13, 2014 at 2:19 am #

    Bob,

    Your report shines light on the HIT industry.

    Your concluding para: “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…”

    What is the evidence that CPOE and CDS systems are safe, efficacious, and usable? Where is the oversight?

    How many $ millions changed hands, hands that may have included those of your protagonist when pushing safety policy and Leapfrog, from HIT vendors to the safety experts and their organizations who promote the myth of HIT?

    There are many who are of the firm belief that the patients and taxpayers are being scammed by the HIT vendors who have funded “research” such as the 2005 RAND study that supported their business plans and influenced the Congress of the United States to pass legislation (HITECH) in their favor.

    • Ross Koppel February 13, 2014 at 1:16 pm #

      One must have faith. Faith-based HIT. The investment in HIT, is now approaching 2 to 3 trillion dollars, and we are only 1/3 of the way there. We wanted something better than paper, which HIT most often is, but it’s still state-of-the-art usability c. 1988 and its interoperability and data standards are about a decade older than that.
      But have faith: In another ten years, it will be much better.

  28. menoalittle February 13, 2014 at 2:32 am #

    Simply an addendum:

    You all want protections and controls to prevent this from happening again.

    If you are serious about that, then start demanding oversight of the HIT industry that is selling EHR, CPOE, and CDS devices free of any oversight, and devoid of any pre or after market surveillance by the FDA or any other body. These devices may be causing more harm than good, and they certainly not have improved outcomes or reduced costs.

    Vigorously oppose the vendor influenced bills in the Congress H.R. 2957 and H.R. 3033, both of which are designed to afford the vendors of HIT protections that ultimately endanger the patients.

    Best regards,

    Menoalittle

  29. Paul Kempen February 13, 2014 at 7:15 pm #

    Christine Cassel has had her hands in multiple cookie jars-not just the $800k ABIM salary and is now under the gun for serious financial conflicts of interest as head of the NQF, she switched jobs with Dr Baron and these articles expose the fact that subjugation of physicians for CEO profits are rampant.
    Bob, How can we have any respect for ABMS organizations when the CEOs have their hands in the money pots of the public and each and every physician in this country?
    Please read:
    http://www.propublica.org/article/payments-to-ceo-raise-new-conflicts-at-top-health-quality-group

    Payments to CEO Raise New Conflicts at Top Health Quality Group

    and:

    Sen C Grassely, Committee of the Judiciary: Letter to C Cassel, MD, CEO Nat. Quality Forum. Feb 3, 2014. At: http://www.propublica.org/documents/item/1012872-2014-02-03-ceg-to-nqf-chloraprep-kickback Accessed 2/12/14

    It is time to wake up and see that these ABMS COMPANIES are out there to fill personal pocket and not to the benefit of any patient OR physician!

    • Michael Millenson February 13, 2014 at 8:21 pm #

      Just to be clear about NQF, Denham and Cassel: the alleged conflicts of interest involving Denham happened before Chris Cassel was CEO. The CEO at the time was Janet Corrigan.

    • Mark Robertson February 17, 2014 at 9:48 pm #

      Bob – I’m interested in your take on the Christine Cassel angle of the story. It looks like there is/was quite a bit of industry crossover at NQF. Since you were the Chair of the Board of Directors of ABIM while Christine was the President and CEO, you must have known of her financial conflicts. Receiving compensation and stock from Premier, Inc. while heading the NQF would certainly be a potential conflict along the lines of what Denham may have been doing. She would be privy to future standards and have even more abilty to steer them in a direction beneficial for Premier’s members. Premier moves way more money than one CareFusion product. How did ABIM reconcile the potential conflict? Thoughts?

  30. Bob Wachter February 14, 2014 at 6:14 am #

    Former investigative journalist Michael Millenson digs deeper into the Denham story in an excellent Forbes blog. If you’re following this story, this is a must read:

    http://www.forbes.com/sites/michaelmillenson/2014/02/14/the-money-the-md-and-a-12-million-patient-safety-scandal/

  31. Rebecca Williams, RN February 15, 2014 at 5:17 pm #

    All efforts with which this man was involved are suspect, especially his work with Leapfrog.

    The fact that he has a patent regarding EHR raises additiopnal suspicions mon his promotion of these technologies as being safe, when there is not any evidence that they are.

    Widespead investigation of the money trail of this man is indicated.

  32. Raj Singh, MD February 15, 2014 at 8:17 pm #

    As a graduate of MIT of Cambridge, Ma., I find the deception of this Madoff like creature who established the TMIT of more than passing interest.

    My degree is in double E. I decided to go to medical school before HIT began to degrade the care processes and work flow.

    The current iteration of EHR programs are appalling. It figures that it takes shamen and the conflicted to promote the mythical benefits of these multi million dollar systems that are meaningfully disruptive to safe and effective care.

    I do not believe for one second that the big name vendors (not unlike Care Fusion) of these products have not spent $ millions lobbying Congress and funding “research” of these systems with preordained results.

    • bev M.D. February 15, 2014 at 8:59 pm #

      It is interesting how readers with a pre-existing anti-HIT agenda are attempting to hijack this forum to pick their own bone. Dr. Singh, I don’t know how old you are, but if you think care processes and flow were efficient before HIT then you are sadly mistaken. I am old enough to remember lost charts and loose lab result slips floating around on wards, to say nothing of illegible notes, on and on. I agree the current generation of EHR’s is inadequate, but we must move forward, not backwards. Perhaps you could use your double E degree from MIT to improve them.

    • FX Hardiman April 19, 2014 at 10:41 pm #

      Dr. Singh hit the nail on the nail on the head. Currently operating EHR and its deployment is degrading our health care system and negatively impacting patient care and safety. Malpractice Defense attorneys, who previously obtained 500 pages of near readable medical records are now getting 1500 pages of computer printout drivel and are having difficulty defending physicians against these claims. You are a quite harsh on Dr. Denham given that nothing has been proven in a court of law. FX Hardiman, M.B., J.D.

  33. Seth T. Greene, MD February 16, 2014 at 10:43 pm #

    Bev,

    With due respect for your opinions, you are off base on that one. Your exageration about paper records is the mantra of the HIT vendors. Denham was more than a casual dabbler in electronic health records and was influential at the Leapfrog that promoted CPOE as one of the great leaps for safety (at the behest of industry that stood to benefit). CPOE is anything but such a leap as the users have come to experience.

    I do not see the truth and integrity in HIT writers hijacking anything from this conversation. In defense of them, they may detect the odor emanating from the HIT industry getting a free pass from oversight and evidence of efficacy.

  34. Hospital MD February 21, 2014 at 3:23 am #

    Conflict-of-interest policies in the for-profit sector make those in non-profits appear soft. Time for an upgrade.

    This sordid saga does appear to be just the tip. There used to be pharma, CME, resident lunches, freebies etc. Now it is specialty Boards and NQF. Sunshine will come, sooner or later

    Moral: If one likes industry, switch over full-time. Else, do not expect a no-longer-gullible audience to accept disclosures and/or pleas of no-conflict

    • Rory Jaffe February 21, 2014 at 4:49 pm #

      The issue with conflicts is fundamentally different between conflicts with your employer and conflicts with a committee. Your employer presumes to have your full time commitment and could reasonably expect you not to compete.

      With committees, conflicts of interest should be expected and must be managed properly. A committee is composed of people whose main loyalties always lie elsewhere. The NQF doesn’t employ committee members full time. NQF needs to have a top-notch conflict of interest training, disclosure, and management program in place, given the high stakes nature of their decisions.

      As a matter of fact, it is the committee members’ full-time employment elsewhere that provides the background they need to be useful.

      Look at the NQF Measures Application Partnership (MAP) membership:
      Virtually everyone on there was selected because they have an interest in the issue, but the interest is due to their full-time job, and that interest will not be completely in line with the interest of NQF’s MAP. So we have representatives from health care providers (don’t want to get lower reimbursement), Accrediting Bodies (don’t want to lose their role), researchers (whose interest is in seeing their particular research focus succeed so they can get promoted), consumer groups (which have their own rating systems and believe those systems should be adopted by others), CMS (which needs to get some measures in place by a deadline or get Congress and the press unhappy, and, oh by the way, already have the measures preselected and would rather not have to redo their work), etc.

  35. Tom Simon, MD February 21, 2014 at 11:37 pm #

    What I like is how the vendors of EHR systems populate the key policy committees of the ONCHIT, and claim that surveillance of the safety of these devices will stifle innovation, among other things.

  36. Pad Reddy, MD February 22, 2014 at 11:35 am #

    Well then but, finally, the sham of a patient safety maven has been outed.

    To all you very very naysayers out there opposed to those complaining about the national HIT sham in electronic medical records, well then but, allow this Denham fraud to be an exemplar of the fraud in HITECH.

    Never ever have I seen the crapola medical systems being deployed and required to manage the care of patients.

    My golly gosh, this is a scandal of immense dimension

  37. Ifoundthis February 22, 2014 at 7:41 pm #

    I am innocent…From one of his sites:

    Home Search Web Meetings TMIT FAQs About Us Disclosures Login
    Charles R. Denham, MD
    To my friends, colleagues, and partners:

    My hope is that the recent news reports have not caused any distraction from your vital patient safety initiatives. If they have, I am truly and very deeply sorry. Your job is tough enough as it is and you don’t need the negative energy right now.

    I was very surprised by the recent events and have had to take the time to collect documents and facts to respond to what has been reported in the press since I was never a part of the whistleblower lawsuit between DOJ and CareFusion. I was as surprised as all of you when the DOJ press release came out.

    I want to reassure you that I am absolutely dedicated to bringing clarity to the issues at hand. In the meantime, I want to thank all of our collaborators and partners on projects for their tremendous outpouring of support and prayers and for their acknowledgment of our core values and body of our work.

    In order to provide clarity as quickly as possible, my advisors have prepared the following statement. I will update you as soon as I can. Thank you for your prayers and support.

    Best regards,
    Charles Denham MD

    It has been reported in the press that the settlement between the government and CareFusion involved a lawsuit in which it was alleged that CareFusion paid $11.6 million in improper kickbacks to Dr. Charles Denham, while Dr. Denham was serving as co-chair of the Safe Practices Committee at the National Quality Forum. These are blatantly false reports.

    The actual whistleblower complaint involved in the settlement between the government and CareFusion makes absolutely no mention of Dr. Denham whatsoever and does not involve him or any of his companies in any way. The whistleblower action revolved around Carefusion’s alleged off-label promotion of one of its products.

    The government’s own press release announcing the settlement apparently contributed to this confusion. In announcing the settlement, the government indicated that the settlement resolved two different sets of allegations.

    The first set of allegations are those raised by the whistleblower complaint – the knowing promotion of ChloraPrep for uses not approved by the FDA and the making of unsubstantiated representations about the appropriate uses of ChloraPrep. These are the allegations made by a whistle blower in the lawsuit that was resolved by the settlement that did not involve Dr. Denham in any way.

    The second set of allegations mentioned in the government press release involves issues about payments made to Dr. Denham for formally contracted services including software development. These allegations are not the subject of any lawsuit.

    It is important to note the following facts regarding the payments mentioned by the government. First, the payments were made pursuant to two different contracts. The two contracts were entered into between Dr. Denham’s company, Health Care Concepts, Inc., and Cardinal Health entities. The first was signed on June 28, 2008 with an effective date of January 1, 2008 and pertained to development of performance models, care path development, and software addressing Surgical Site Infections, MRSA infections, Blood Stream Infections, Urinary Tract Infections, Ventilator Acquired Pneumonia, and Clostridium difficile infections. The second contract signed and effective on October 1, 2008 was a research grant agreement to address automated infection identification systems and measures. Neither contract mentions ChloraPrep or its ingredients. Both contracts pre-dated the existence of CareFusion as a company. Both of these contracts pre-dated the announcement of a study that was published in the New England Journal of Medicine that related to ChloraPrep and consideration of that study by the National Quality Forum. The first contract pre-dates the actions of the National Quality Forum by more than one year; the second contract pre-dates the actions of the National Quality Forum by more than ten months.

    In seeking to resolve the whistleblower action, CareFusion reached an agreement with the government to resolve both the whistleblower lawsuit as well as an inquiry that has not resulted in the filing of a lawsuit.

    Dr. Denham has cooperated in the past with the government’s investigation of CareFusion and will continue to do so in the future.

  38. Bob Wachter March 3, 2014 at 1:58 am #

    Thanks, everyone, for an extraordinarily interesting and thoughtful discussion, befitting the complex issues raised by the Denham case.

    Based on feedback from Patrick Romano, a member of the NQF Safe Practices committee, I have made some minor revisions to two paragraphs: the ones beginning with “The picture has become clearer…” and “Equally concerning…” These changes don’t change the substance of the argument; they simply clarify that Denham’s influence was different when it came to Safe Practice 21 (CLABSI) and Safe Practice 22 (surgical site infection). For SP 22, Denham did lobby the committee to include specific language that endorsed the use of the CareFusion product. For SP 21, the specific language endorsing ChloraPrep was not discussed by the committee, but rather simply materialized in the final report. My original version combined these two practices, implying that Denham had lobbied the committee on both the CLABSI and SSI standards.

  39. Colleen Inouye March 4, 2014 at 3:03 am #

    My question is : Is ChloraPrep really better than Betadine? Were these studies conducted properly? It seems at my hospital there has been a higher infection rate after ChloraPrep. Was there influence to the study? Certainly Betadine is cheaper than ChloraPrep.

    • Matthias Maiwald March 6, 2014 at 8:31 am #

      To answer your question, yes, “chloraprep” can be assumed to be better than “betadine,” but this comparison, as it is often made by many healthcare professionals, is flawed. This is because it is a comparison between two antiseptics (chlorhexidine plus isopropanol) against only one (povidone-iodine). A better comparison would be between two antiseptics (e.g. chlorhexdine-alcohol) versus two antiseptics (e.g. povidone-iodine-alcohol). For a clarification and some background information, please see my earlier post above and the articles cited within. The other thing that is not commonly known is that there may be significant differences in antimicrobial performance between different povidone-iodine products, even if they seemingly contain the same amount of ingredient. This is because the dissociation kinetics of the iodine from its organic carrier molecule (and resulting activity) are highly formulation-dependent.

  40. Patrick Romano, MD MPH March 17, 2014 at 8:33 am #

    After carefully reviewing Bob Wachter’s excellent summary of the “Denham affair,” honestly discussing the affair with ProPublica’s Marshall Allen and Modern Healthcare’s Joe Carlson, considering my own role in the affair as a member of his National Quality Forum (NQF) Safe Practices Committee, and writing down random thoughts at various times over the past month, I finally decided to “clear the air” (or at least my mind) by contributing some memories and ideas, here and elsewhere.

    Some of the criticism of Chuck Denham, in this blog and elsewhere, appears to focus on the business model that he developed to support his work on patient safety. Insofar as one can ascertain from public documents, his business model was built largely on helping developers and producers of safety-enhancing products and services to increase their revenues through creative product placement, endorsements by prominent individuals and organizations, and other marketing efforts. This, in itself, is not a sin – it is simply a business model.

    Even the most innovative products and services require carefully designed marketing efforts to penetrate a highly regulated market that can be difficult to enter, with buyers who are often reluctant to invest in unproven technologies. As Forbes’ Michael Millenson notes, and as I would agree, Denham has been “genuinely consumed by improving patient safety”; all evidence suggests that he adopted this unusual business model to support his work on patient safety, not the other way around.

    Each of us who works in quality and safety has developed our own business model to support this work. Mine happens to focus on contracts (through my employer, the University of California) with public agencies that are involved in developing, implementing, or evaluating measures of quality and safety in health care. Bob’s business model is built, at least partially, on selling books, including what he coyly describes as “the world’s top-selling patient safety textbook.” Another leader in our field, Atul Gawande, earns substantial speaking fees (some of which are contributed to charitable organizations). Many others earn their income by leading quality and safety efforts within health care organizations. Noting these facts does not, in any way, diminish the value or accuracy of our respective contributions to public discourse.

    The prophet John quoted Jesus as saying “He that is without sin among you, let him first cast a stone.” Who am I – who is anyone – to say that any of these business models – selling books, selling personal appearances, selling technical services to public or private entities, or promotional services to producers – is better or worse than any other? Indeed, a cynic might argue that we are all profiting from the misfortune of patients who have suffered as a result of medical errors or other quality lapses.

    Perhaps, but I prefer to think otherwise. I prefer to think that each of us is trying to fill a niche, to use our skills and abilities – as best we can – to advance the cause of patient safety by focusing attention on the problem and pointing the way toward potential solutions. Denham’s obvious communication and leadership skills helped to bring people together, empowering patients, families, and advocates who needed a “loudspeaker” to amplify their voices, engaging nurses who had been scapegoated by unsafe employers, and partnering with employers (through the Leapfrog Group) to push health care organizations relentlessly to adopt safer practices. He did not exploit or swindle any person, unlike Bernie Madoff, and his promotion of ChloraPrep on the Safe Practices Committee did not harm a single patient (except perhaps indirectly, to the extent that CareFusion was able to command an inflated price for its ChloraPrep products). Also, it does not appear that Denham broke any Federal law. (If he had broken a Federal law, then presumably the Department of Justice would have done more than accuse him of receiving kickbacks in a press release, and then immediately exit the scene.)

    So what DID Denham do wrong? Quite simply, he committed two cardinal sins in our world of guideline-writing and standard-setting committees. First, he failed to disclose relevant conflicts of interest, not only to NQF staff, but perhaps more importantly, to his colleagues on the Safe Practices Committee. (Admittedly, he might have squeaked through a now-closed loophole that only required disclosure of direct conflicts of interest; the contracts in question presumably benefited him indirectly through companies that he owned.)

    Second, he not only failed to recuse himself from discussions and votes related to his conflicts of interest (which is the normative practice in such situations), but he actively advocated for positions that benefited his companies’ client(s), essentially turning what was supposed to be a scientific panel into a forum for interest group advocacy. The second problem followed from the first, but a less ethically challenged participant would have recognized the conflict of interest and recused himself, when appropriate, even if he had not been compelled to disclose the conflict.

    A related question is whether and how members of guideline-writing and standard-setting committees should benefit from their service on these committees. All of us who serve do so as volunteers, and thus anticipate some indirect benefit through professional recognition. In the University of California, for example, promotion to the upper ranks of the Professor series requires “evidence of highly distinguished scholarship, highly meritorious service, and… excellent University teaching … (with) great distinction and national or international recognition.” Therefore, my service on NQF’s Safe Practices Committee, through an indirect and tenuous path, could conceivably lead to a higher professorial rank when I retire, and hence to a higher pension benefit.

    But Denham had a more direct ability to profit from his service to NQF, because his annual income depended on his credibility and stature in the field, and his ability to “monetize” this credibility and stature through consulting agreements with health care providers and producers. Hence, it is troubling that Denham’s nonprofit organization underwrote an NQF project from which his own companies stood to profit. These entanglements are all too common in the “guideline industry”: a previous NQF project on deep vein thrombosis was partially supported by Sanofi Aventis, which manufactures Lovenox (enoxaparin), and the American College of Chest Physicians’ well-respected guidelines on prevention and treatment of thrombosis were supported by Bayer, which manufactures Xarelto (rivaroxaban) and numerous aspirin products.

    According to recent news reports, Senator Chuck Grassley (R, IA) is launching an inquiry into the Denham affair and NQF’s due diligence practices. Please excuse my skepticism about a conflict of interest investigation led by someone whose campaign and leadership committees have received $421,952 from insurance industry sources over the past 5 years, including $34,600 from Leon Medical Centers (a Miami-based Medicare Advantage plan and service provider) and $29,500 from Blue Cross/Blue Shield. Following NQF’s current conflict of interest policies, Grassley should not exercise his Finance Committee vote on any matters affecting the insurance industry.

    Even if Denham affair is not quite a scandal, as I have argued, there are still lessons that must be learned. First, I’ll emphatically second Bob’s comment that “when something seems odd, nearly inexplicable, perhaps things really are not right.” All of us who worked with Denham were too quick to overlook the clues, to avoid asking the tough questions, and to accept his energy and enthusiasm at face value.

    Second, we need to disabuse ourselves, and everyone involved in the guideline-writing or standard-setting process, that ANY of us is free of conflicts of interest. Everyone involved in health care – including medical school professors like me, patient advocates, and most of the other contributors to this discussion – has potential conflicts of interest, whether we wish to acknowledge them or not. It is, in fact, these potential conflicts that make us “experts” worthy of participation in the process. Instead of starting committee deliberations with a pro forma announcement of “no conflicts,” we should press each other to divulge and to explore the potential conflicts that all of us have. Only through exposure and discussion can we prevent these potential conflicts from becoming real conflicts.

    Third, guideline-writing and standard-setting processes need to be transparent, so that anyone can understand how key decisions were made and who influenced those decisions. Although some might use these events as an opportunity to criticize the NQF, I have been impressed by how NQF leaders have acknowledged the problems that Denham caused, shared the information necessary to investigate these problems, and implemented a process to identify and correct Safe Practices that were tainted by conflicts of interest. Indeed, these events illustrate the importance of the NQF as a neutral, publicly supported convener of stakeholders in American health care. Another private organization doing the same work, even an enlightened nonprofit foundation or professional society, would be unlikely to release verbatim transcripts of meetings and internal draft reports. A government agency doing the same work would offer similar transparency, but would raise widespread concerns about “government control” of health care. The NQF offers the transparency and accountability of a public agency, with the stakeholder engagement and explicit balancing of different perspectives that only a consensus-based, non-governmental entity can achieve. This model is actually improving quality in health care, as it has done previously in other industries.

    So as we consider the ramifications of the Denham affair, and learn important lessons from our collective mistakes, let us not lose sight of the true scandals in patient safety. In the UK, mismanagement and misallocation of resources were blamed for hundreds of excess deaths in the Stafford Hospital and Bristol Children’s Hospital scandals. Here in the US, Dallas’ Parkland Memorial Hospital was fined $1 million for “egregious deficiencies” that resulted in at least one patient’s death, another patient’s leg amputation, and other harms. Los Angeles’ King/Drew Medical Center was finally shut down in 2006 after several unnecessary deaths related to persistent mismanagement. Murderous health professionals, such as the infamous Charles Cullen (of New Jersey’s Somerset Medical Center) and Orville Majors (of Indiana’s Vermillion County Hospital), have been allowed to continue practicing for years after colleagues became suspicious, bouncing from hospital to hospital. Closer to home, a 57 year old woman was recently found dead, presumably from dehydration, after wandering into a stairwell at San Francisco General Hospital. Twenty years earlier, a prominent reporter in Boston died from an overdose of chemotherapy, perhaps inspiring the modern medication safety movement. Between these two events, tens of thousands more have died or suffered prematurely as a result of problems in how we deliver health care. These are the true scandals in patient safety.

    The Denham affair is an unfortunate distraction – an important reminder that money can corrupt, in health care as in politics and every other enterprise – but it should also prompt us to rededicate ourselves to the real task at hand – to make American health care safer, more effective, and more efficient than it has ever been.

    Additional references and links are available upon request.

    • Michael Millenson March 17, 2014 at 4:12 pm #

      Thank you, Patrick, for that extremely thoughtful commentary.

      One small point of personal clarification: I have a blog page on the Forbes.com site called “The Examining Table,” but I am not employed by Forbes nor do I receive any compensation from them. Although they write quite a bit about billionaires, in my case I guess fame will have to substitute for fortune. :-)

      • Patrick Romano, MD MPH March 17, 2014 at 8:17 pm #

        Oops, sorry about that, Michael. I thought about posting on your blog page too, but fortunately you saw my comments here :-)

      • Ross Koppel March 18, 2014 at 3:18 am #

        I very much appreciated the commentary. One slippery slope argument, however, concerns me: It’s too facile to say most of us have some conflict of interest and involvement. There’s a difference between having involvement in a company that makes money on a product or service vs getting paid to lecture on general patient safety or selling books on patient safety. I am working hard to allow physicians to report problems with the EHRs and CPOE systems they use. I’ve thought about software to help physicians report hazardous software. But I’ve not shorted Healthcare IT vendors’ stock. And if my writing has influenced policy, it’s to seek vendors and government agencies to improve the quality of the HIT. I make no money by patient harm or physician frustration, although concerned clinicians might be more interested in my writings than are those who are delighted with their EHRs and CPOE systems.

        • NE March 20, 2014 at 2:08 am #

          A lot of Dr. Romano’s points make sense, but I think we still have no idea what Dr. Denham and his company did to receive $11,600,000.00 from the makers of Chloraprep.

          Unless that is answered in a way that ethically allows for that kind of money being transferred, I don’t think I will have the idea in my head that what Dr. Romano, and other people like him serving on committees and panels for various agencies and organizations, is doing is basically the same thing that Dr. Denham was doing a few years ago.

        • Suzanne Gordon March 25, 2014 at 2:26 pm #

          Thank you Ross for the comment. I have been wanting to write in response to Patrick Romano’s comment, which I found as disturbing as thoughtful. I was particularly worried by the discussion of different people in patient safety finding different “business models” to finance their work. It seems to me,as you point out, that there is a difference between patient safety as goal and ethical mission and patient safety as business or business opportunity. This blurring of distinctions between healthcare/medicine as business and service is one that runs through all of American medicine and is a foundational factor in many patient safety incidents — like prescribing medications and treatments that are not of use to the patient and endanger patients. ( see my oped and blog post on this issue http://www.suzannegordon.com)
          Having a “business model” that earns you $11.6 million, palatial homes and private jets is not required by most of us who work in patient safety. It’s not just another “business model” and is not equivalent to getting an academic promotion or having a patient safety book that is a good seller. Unless Bob is netting millions off his book, which I doubt he is, or academic promotions come with eight figure salaries these days, I think we really need to make a distinction between people who make a living doing good work and people who seem to be making a killing. I hope this doesn’t sound like a rant, which it isn’t intended to be. But really, is enough never enough?

  41. Linda Groah March 25, 2014 at 5:39 am #

    good infrmation

  42. Paul Kempen, MD, PhD March 26, 2014 at 9:58 am #

    Anyone interested in an Update on the status and ethical shortfalls of the ABIM and ABMS MOC program can view an Update at:

  43. Matthias Maiwald April 30, 2014 at 12:44 am #

    Further to my earlier posts (see above), here is some additional (new) information:

    Maiwald M, Chan ESY. Pitfalls in evidence assessment: the case of chlorhexidine and alcohol in skin antisepsis (Leading Article). J. Antimicrob. Chemother. (2014) Advance Access.
    http://dx.doi.org/10.1093/jac/dku121

    In this article, we are discussing the scientific, ethical, patient safety and infection control implications of a widespread evidence misinterpretation surrounding chlorhexidine as a skin antiseptic, as well as broader implications for evidence-based medicine that this has.

  44. Mike Copper May 6, 2014 at 8:29 am #

    I think chuck was was deeply committed to his patients safety. He was a hard working businessman who earned a lot of money from this.Yes, Chuck and Bernie both seemed honest to their work— that’s true. But Bernie was a little greedy. Chuck? I don’t know much, but what makes this case as much a cause for sadness as anger is the strong suspicion that the road to hell was paved with hard work and good intentions.

Trackbacks/Pingbacks

  1. Who’s really in charge? Definitely not the patient – and maybe not the doctor. | The Digestive - January 30, 2014

    […] the strings – be it a spouse, the head of your department, or something more malevolent. Chuck Denham, one of the heads of the patient safety movement in the USA, is facing allegations that he was paid $11.6 million to promote the choice of particular safety products in healthcare. […]

  2. NQF: MOC Smoking Gun | IP4PI – Independent Physicians for Patient independence - February 4, 2014

    […] freedominmedicine Correspondence from Ken Christman, MD: You guys are fantastic!  Thanks for uncovering the Chuck Denham story and the $11.6 million bribe, with the connection to National Quality Forum (NQF).  This is a real […]

  3. TMIT, Dr. Chuck Denham, and Patient Safety’s First Scandal?--Casey Quinlan « Knowledge of MedicineKnowledge of Medicine - February 5, 2014

    […] and others who list themselves on Texas Medical Institute of Technology‘s SpeakerLink,this very meaty post by Society of Hospital Medicine founder and world-renowned leader of the hospitalist movement Dr. […]

  4. Leadership – to serve or to be served? — db's Medical Rants - February 14, 2014

    […] Two recent accusations of conflicts of interest should remind us of the dangers of leadership.  Patient Safety’s First Scandal: The Sad Case of Chuck Denham, CareFusion, and the NQF […]

  5. The Doctor Weighs InThe Money, the MD and a $12 Million Patient Safety Scandal - February 16, 2014

    […] example, assertion that his products “are in more than half the hospitals in America” aroused skepticism from patient safety veterans such as Dr. Bob Wachter and others. There are questions about the […]

  6. Tale of kickbacks in healthcare IT | Medical and Health Blog - April 15, 2014

    […] Is it wrong to be skeptical about the integrity of quality measures in meaningful use, particularly in the wake of what one quality-improvement expert called "patient safety's first scandal"? […]

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