The CareFusion/ Denham/ NQF Case - the Plot Thickens

The story about CareFusion, its financial relationships with Dr Charles Denham, and his alleged role in promoting a CareFusion product through standards produced by the National Quality Forum has gotten even more complicated.  This means that the tasks faced  by National Quality Forum leaders who asserted their intent to improve their conflicts of interest policy in response to this case just got more complex.

Background

As we most recently discussed here, the basics of the case were:
-  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice
 -  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative and other health care skin cleaning
-  the Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision
-  NQF leaders asserted that after hearing of the case from the DOJ, the organization severed ties with Dr Denham and the non-profit organization he runs,  established a policy not to accept money from funding organizations whose leaders are on its committees, reviewed all the standards set by the committee of which Dr Denham was co-chair, and twice revised its conflict of interest policy.

I opined that the NQF response to this case was more open and pro-active than responses by many other organizations to cases involving conflicts of interest, although there was still room for the NQF to further strengthen its conflict of interest policies.

The Plot Thickens

Since last week, three more articles on the case have appeared, in Modern Healthcare, the WBUR CommonHealth blog, and on ProPublica.  These pointed out additional disturbing aspects of the case.

Dr Denham's and CareFusion's Relationships with the NQF Were Even More Complex than Heretofore Revealed

According to ProPublica,

in response to questions from ProPublica, the Quality Forum divulged that Denham’s nonprofit was one of its contributors, and that in 2007 and 2008 it received $485,000 in donations from a foundation affiliated with Cardinal Health, a company that spun off CareFusion in 2009.

Also,

Between 2006 and 2009, Denham’s nonprofit donated $725,000 to the Quality Forum. The group and Denham had a five-year contract, but the Quality Forum declined to provide a copy or explain the terms, saying only that it was ended three years early, in 2010, after concerns about Denham emerged. 

Not only did the non-profit help fund the NQF, it was directly involved in relevant NQF activities,

According to [Dr Denham's attorney Lawrence] Gondelman, Denham’s nonprofit was obligated to provide financial and staff support for Quality Forum projects, including evidence-based medicine reviews, hosting webinars and creating multimedia presentations about the safe practice recommendations.

 Furthermore, while the NQF asks committee members to disclose conflicts of interest verbally at the start of each meeting, again according to ProPublica,

Both [Dr Patrick] Romano and Dr. Peter Pronovost, who leads a patient safety institute at Johns Hopkins Medicine, said they had been unaware of Denham’s financial ties with CareFusion. Quality Forum officials said Denham never reported them, nor did he mention them during the 2009 meeting when members were asked to disclose their financial relationships, the transcript shows.

'He clearly lied,' Dr. Christine Cassel, the Quality Forum’s president and CEO told ProPublica. 'He just didn’t say anything about any of his business relationships.'

The Clinical Evidence in Support of the CareFusion Product Denham Touted was Dubious

According to ProPublica's review of a transcript of the meeting about the NQF standards that Denham co-chaired,

At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a 'major journal' would show the effectiveness of the 2 percent chlorhexidine antiseptic.

CareFusion's ChloraPrep is apparently the only well known 2 percent chlorhexidine antiseptic.

However, the same article pointed out that the study too was affected by conflicts of interest. Its authors "all reported ties to Cardinal Health,' the company from which CareFusion was spun off.  Furthermore, ProPublica charged that Dr Denhams company was involved with the financing of that study.

Also, per an interview with Brian Johnson, publisher of MassDevice.com, WBUR reported:

the government says there are several ways this study did not use accepted protocols. For example, a member of the company’s sales and marketing staff reviewed the data from the clinical trial and edited the final study. Prosecutors also say the company failed to 'review, evaluate and report safety information' and failed to obtain and maintain accurate records showing all financial transactions from CareFusion to Dr. Rabih Darouiche, the lead investigator on the study.

Thus, it appears that this study may have been manipulated (in particular, by a company marketer's editing) to make its sponsor's product look more favorable (in this case, particularly by ignoring data about safety and adverse effects)

 NQF Went Farther to Endorse CareFusion's ChloraPrep than Was Heretofore Appreciated

 According to the WBUR interview,

The NQF didn’t adopt a recommendation of Chloraprep but Denham hosted webinars with Dairouche under the NQF brand for hospital staffers that absolutely endorsed Chloraprep. So while it didn’t end up in the official financial recommendations, there certainly was influence. 

However, according to ProPublica things were even more complicated.  Denham promoted ChloraPrep in not one, but two instances,

At the safe practices committee session on Aug. 19, 2009, Denham twice appears to reference the New England Journal of Medicine study, the meeting transcript shows. Although he did not cite the study or ChloraPrep by name, Denham remarked that research to be published soon in a 'major journal' would show the effectiveness of the 2 percent chlorhexidine antiseptic.

[Dr Peter] Pronovost said it wasn’t necessary to actually identify ChloraPrep because it was well known as the product with the 2 percent chlorhexidine formulation.

The committee members agreed that chlorhexidine was an effective antiseptic – guidelines by the Centers for Disease Control and Prevention (CDC) say so as well. But studies show it also works in other concentrations and combinations.
Discussion turned to recommendations for preventing infections caused by central lines, the thin tubes inserted into a vein to deliver fluids or medications. Dr. Gregg Meyer of Massachusetts General Hospital in Boston, the co-chair of the committee with Denham, brought up the forthcoming study.

'Chuck (Denham) made me aware of it,' Meyer said. He then asked Pronovost, a leading expert on preventing central-line infections, what he thought

The final report did delete the specific reference to ChloraPrep as the preferred method for preparing surgical sites,

.After the meeting, when the committee’s draft report was published in late 2009, a recommendation for preparing surgical sites to prevent infection did not name ChloraPrep but did specify its telltale formula – a 2 percent chlorhexadine and alcohol antiseptic.

That draft recommendation was challenged by 3M, a company that makes a competing product. A scientific review of the evidence by a Quality Forum ad hoc committee found a lack of clear evidence to support one skin prep product over another. As a result, the recommendation to use the ChloraPrep formulation on surgical sites didn’t make it into the final 2010 safe practices report. 

However, the final report did appear to endorse ChloraPrep for reduction of central line infections,

 On the separate issue of reducing central-line infections, the 2009 draft report endorsed a chlorhexidine antiseptic but did not specify any one concentration – just as the committee decided. Yet the final 2010 report does call for a 2 percent chlorhexidine and alcohol antiseptic like ChloraPrep. 

Also, again per ProPublica, the NQF seemed to have been roped into other efforts run by Dr Denham to promote ChloraPrep,

Although Quality Forum officials seemed surprised to learn this last week from ProPublica, the group is listed as a co-host, with Denham’s nonprofit, of a webinar where the 2010 safe practices guidelines for central-line and surgical site infections are presented.

The presentation, posted on the website of Denham’s nonprofit, states that the Quality Forum recommends the ChloraPrep formulation to protect against both central-line and surgical site infections.    

CareFusion also cites the Quality Forum’s endorsement in at least one brochure on its website.

Summary: a Longer Row to Hoe

It looks like NQF will have to deal with even more specifics if it wants to prevent future compromises of its standards due to conflicts of interest and manipulation of the clinical research evidence base.

It will have to consider:
-  Whether individual disclosures of conflicts of interest can be trusted
-  Whether it is prepared to deal with the apparently nearly infinite variety of conflicts that creative minds can produce to promote vested interersts
-  How to be appropriately skeptical of clinical evidence used to devise standards when such evidence is now so susceptible to manipulation and/or suppression to further vested interests
-  How to better recognize the various kinds of machinations that the conflicted may endeavor to promote their interests

Again, my question is whether it may just be better to ban individuals with conflicts of interest from roles in which they may influence standards in favor of vested interests, rather than continuing to try to "manage" the complex web of conflicts and the actions they may produce generated by an increasingly commercialized and simultaneously poorly regulated health care system.

By the way, if anyone in other organizations is sitting back thinking this is just an NQF problem, they ought to think again.  As we have discussed, the web of conflicts of interest, both individual and institutional, is vast, and the extent of manipulation and suppression of the clinical research base is equally vast.  Every health care decision maker, health policy decision maker, and health care organization is confronted by similar problems which may differ only in the details.

Again, I applaud the NQF for trying to deal with these issues upfront, and hope that others will learn from the lessons this case provides.

Martin Health System, Florida: Our EHRs were out for two days, but patient care has not been compromised, sayeth Pinocchio

This is yet another post in my ever-growing "our EHRs went out due to IT incompetence, and chaos ensued, but patient care has not been compromised" series (see query link: http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised):

Martin Health System looking into network outage that slowed hospital operations
Posted: 01/24/2014
By: Meghan McRoberts
http://www.wptv.com/dpp/news/region_martin_county/martin-health-system-looking-into-network-outage-that-slowed-hospital-operations

MARTIN COUNTY, Fla.-- Martin Health System is looking into what caused some computer hardware to fail Wednesday, leading to network outage in all of the Martin Health System hospitals.

Things were back to normal Friday morning, according to hospital spokesperson, Scott Samples.

Translation: for two days there was a complete network outage, with no EHRs, email, CPOE etc.

But since Wednesday night patients say the atmosphere around the hospital was chaotic.

Patients likely noted doctors and nurses running like headless chickens.  I note that chaos and safe medical care are not good bedfellows.

Hospital staff, doctors and nurses access the computer system to read patient charts and medical information. Without it, they were left digging into paper documents.

The paper documents left laying around would have best had scanty, sparse patient information, since the computer in computerized hospitals has become the primary source of truth.  (One might think such a system, including the network, would be hardened against failure, but a two-day outage, as per other outages at the query link above, show this is often not the case.)

Samples says this led to some minor inconveniences around the hospitals, where some patients received their meals later than normal. Some outpatient appointments could not be scheduled, and extra nurses and administrative staff were brought in to help with the increased work load.

No medication or treatment was jeopardized.

There we have it.  In Pinocchio-like fashion we hear the obligatory "we lost all our information systems, which are our central nervous system for patient care, but patient care has not been compromised" statement from hospital PR.  This statement is questionable on its face. 

The risk of accident was significantly increased on its face.

New patients information was taken down on paper, and put into the system on Friday. Samples says there was a back up computer for data from former patients.

The future will be in question depending on the quality, or lack thereof, of this "backload" of patient information that was collected during what patients themselves described as "chaos."

Of course, according to the IT pundits paper itself, even under ideal circumstances, is so risky that tens or hundreds of millions of dollars per hospital has been spent to replace it.  Someone is not being truthful.

The hospitals that experienced the outage were Martin Medical Center, Martin Hospital South, and Tradition Medical Center.

But patient safety risk was not compromised at any of them, so sayeth the figure below.

All our EHRs and other clinical IT were unavailable for two days ... patients reported chaos ... we had to delay or cancel appointments and bring in extra clinical staff to maintain order ... but patient safety was not compromised, except for some late lunches!

Pinocchio must be working at a lot of hospitals. When EHRs are out, patient safety is compromised. This is not open for debate, it is an "on its face" issue. These systems need hardening so as to be up and available 100%. Period. People responsible for outages need to be held accountable, including in a court of law if patients are injured or die as a result. Period.

Finally I note that, with the corporatization of healthcare and with population of executive offices by lightweights with unquestioning faith in "cybernetic miracles", the credo of my early 1970's medical mentor, cardiothoracic surgery pioneer and educator Victor P. Satinsky, MD (link) - "Critical thinking, always, or your patient's dead" - is more valuable than ever.

-- SS

WINDY CITY BLUES

WINDY CITY BLUES

There is an academic ethics mess brewing in the windy city… at The University of Chicago. It involves a start-up Chicago corporation, a star statistician in the medical school, seed money in the form of NIH research grants, the American Psychiatric Association, and the chairman of the APA’s DSM-5 Task Force. It involves the appearance of self-interested bias in the DSM-5 process. It involves a recidivist pattern of failure to disclose material conflict of interest. And it involves academic journal editors (JAMA and JAMA Psychiatry) who did not do the right thing when the perps were outed.

I broke the story on this site back in November, right after a confession appeared on-line in JAMA Psychiatry by the gang of five perps (Robert Gibbons, Ellen Frank, David Kupfer, Paul Pilkonis, and David Weiss) . Indeed, it was I who had alerted the journal. Others have since weighed in here and here and here, for instance. The definitive summary and Timeline were the work of Dr. John M. (Mickey) Nardo here. Of course, readers of JAMA Psychiatry would never know that the authors were outed. The editors (Howard Bauchner for JAMA and Joseph Coyle for JAMA Psychiatry) allowed the authors to make it seem like they were making a spontaneous admission of nondisclosure, and they acquiesced in the withholding of key information that I had given to the journal.

It gets worse. We now know that the chair of the DSM-5 Task Force (Dr. David Kupfer) failed to disclose his financial conflict of interest on at least 4 occasions (#s 13, 15, 16, 19 in the Nardo Timeline). On two of those occasions he was representing the DSM-5 team and the APA! These lapses undermine his repeated assurances that COI issues were under control in DSM-5. If the chairman of the DSM-5 Task Force does not have his own act together concerning COI disclosures, then what are his assurances worth? Nevertheless, the APA released a statement that tried to whitewash Dr. Kupfer’s nondisclosures. They need to recalibrate their ethical compass.

The methods adopted in this affair are classic: Peddle unproven psychiatric screening scales backed up by black box statistics (a distressing specialty of Dr. Gibbons); publish a glowing report in JAMA Psychiatry, which you have infiltrated (Ellen Frank and Robert Gibbons are on the editorial board); get your corporate people inside the DSM-5 process (David Kupfer, Robert Gibbons, Paul Pilkonis); slant the DSM-5 process to endorse, however weakly, the kind of products you intend to market; start a corporation without telling anybody and establish a website  with advance marketing that touts your new academic publication in JAMA Psychiatry while highlightingDr. Kupfer’s key role in DSM-5; loudly proclaim (see page 4) the advent of population-wide screening but before doing any serious field trials or acknowledging that most positive screens will be false positives. This is the usual dodgy hand waving of wannabe entrepreneurs, whose vision is obscured by dollar signs. Oh, and did I mention regulatory capture of NIMH for over $11 million in funding while not producing a product worth a tinker’s damn?

In response to all this adverse commentary, the authors and the journal editors have gone to radio silence. They must be hoping it will blow over.  If anything, their silence has provoked even more searchlight questions that focus on what is happening at The University of Chicago.

For instance, who is bankrolling this start-up corporation? Last summer they brought on board an executive named Yehuda Cohen who is a mover and shaker in Chicago business circles. I am sure he doesn’t work for peanuts. He set up a website that must be staffed to respond to queries from consumers and professionals. Plus, the corporate office appears to be located in prime commercial space at 217 N Jefferson #600, Chicago IL 60661; phone 312-878-6490. E-mail: info@adaptivetestingtechnologies.com(from the website: you can find a picture of the neighborhood on Google). So, they are racking up significant operating expenses already. Heaven forfend that these expenses might be covered directly or indirectly by their NIMH funding! Are the responsible administrators at NIMH and at The University of Chicago looking and auditing?

It is also unclear whether they have a sound or even a legal business plan. Where will the high powered computing needed for their expansive applications be conducted? Do they have a computing facility at the corporate office? Or do they intend to perform the commercial computing through the NIH-supported Center for Health Statistics at The University of Chicago, which Dr. Gibbons personally directs? If so, did the University sign off on that plan? Is NIH aware of the plan?

In late November I asked NIH about the ownership of the data bases and algorithms on which the corporation relies for the business plan. I received a reply from NIH outlining the applicable federal policy and stating “We understand that the data are deposited and made available to the community per request through the Center for Health Statistics.” That had to be what Dr. Gibbons told them. Notice that no mention was made of the algorithms. I have replied to NIH, asking them to clarify the status of the algorithms, without which the data bases alone are of little use. I also pointed out to NIH that there is no mention of this public access option in any of the publications from these authors or on the corporate website. This situation is typical of the dissembling style we have seen before from Dr. Gibbons and Dr. Kupfer – lacking in candor and transparency.

The more one looks, the more questions arise. Is The University of Chicago being taken for a ride? Is NIMH being taken for a ride? Are we all being taken for a ride? Can we please have some transparency here? Can we please have some psychometric standards here? Will the APA step up to the plate? Will NIH step up to the plate? Will The University of Chicago step up to the plate?

Physician whose mother had heart surgery reflects on sane EHR use

The following from a physician I know, an ED physician, on the care their mother received at a major academic medical center's teaching hospital using EHR.

Emphases mine:

Mom just had aortic valve at hospital [name redacted] associated with [redacted] Medical School.  EHR used was [major EHR vendor name redacted] but it clearly had been pushed into the background......

1) Every ICU patient also had a printed chart in a notebook (paper) medical record book kept at the nursing station.  Just like the old days. It was the most commonly used source of info to the residents and staff.

2) Not once did I see an EHR physically come between a patient and a staff member (as opposed to nearly every encounter where I work).

3) Mom's (and every ICU patients) plan for the day was outlined in magic marker directly on the glass doors and windows and updated during rounds....available for immediate reference, not buried in an EHR.

4) Her clinical info was accurate....... it was dictated and not fabricated from pick lists or dot phrases.

5) Clerks put in the data and Dr's orders......apparently they long ago figured out the nonsense called CPOE and let the clerks do it.

I suspect many major University hospitals have worked around the workflow barriers and most egregious documentation sins.  The doctors there (at least in that Cardiothoracic ICU) have enough clout that they can just say HELL NO.  Those of us working for less astute/ non cutting edge community hospitals run by "also ran" healthcare corps are left to bear the crosses ONCHIT and the EHR industry have dumped upon us.

I am grateful to the folks at [hospital] for an excellent job on my mom and demonstrating that efficient healthcare pushes the EHR (as currently sold and configured) to the back burner.

Oh, [EHR name redacted] still is loaded with those prefilled templates and copy/ paste pull forward geared for upcoding.....but these "top of the food chain" docs just didn't waste their time with them.

Having had to gut and remediate really, really terrible health IT for invasive cardiology and cardiac surgery years ago (http://cci.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=Cardiology%20story), and revise workflows to relieve busy clinicians with critically-ill patients from the stupidity and time-sink of fiddling with balky computers with poorly-designed software, I identify with this physician's observations and beliefs.

As I've stated in previous posts, most clinicians need to be relieved of clerical tasks associated with computers, especially data entry and ordering, not just surgeons.

If the data is really that valuable, hiring clericals to do clerical work should remain a true bargain, with massive return on investment.

If that is not the case, then the data is really not that valuable.

-- SS

Putting in the Ski Lifts - National Quality Forum Leaders Improve Conflict of Interest Policies in Response to CareFusion Case

The complex case that came to light with reports of a legal settlement by CareFusion of allegations that it paid kickbacks to promote its ChloraPrep product just got even more complex, but now also a bit more hopeful, and hence much more hopeful than most of the cases we discuss..

Background


As we noted yesterday, the CareFusion settlement seemed routine when it was first briefly reported in the media.  Then Modern Healthcare published a series of articles about its ramifications, the latest appearing today.

In summary prior to the latest article,
-  the CareFusion settlement for $40.1 million was made in response to allegations that kickbacks were made to promote ChloraPrep, a solution meant for preoperative skin cleaning
-  the Department of Justice news release also alleged that payments were made to a corporation called Health Care Concepts to conceal kickbacks made to its owner, Dr Charles Denham
-  the implication was that Dr Denham was supposed to influence a standard writing committee run by the National Quality Forum, a well known organization that promotes quality improvement, issues authoritative practice standards, a form of clinical practice guidelines, and has contracts with the US government for quality of care activities
-  the draft of the standard written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision

We noted that the NQF policy on conflicts of interest for its standard writing committees seemed somewhat weak.  The current (October, 2013) policy asks members to internally disclose conflicts and recuse themselves from " discussion of the applicable measure or measures, and in some instances competing and related measures."  However it does not ban members with conflicts, nor require public disclosure of conflicts.  We also noted that NQF has several board members who have full-time leadership positions with health care corporations, financial firms that invest in health care, or health care trade associations, and NQF received funding from pharmaceutical companies and their in-house foundations.  Thus NQF appears to have its own institutional conflicts of interest. 

So we thought that the case raised questions about how well NQF standards are protected from the influence of conflicts of interest, and whether they should remain so influential in the absence of stronger protections?

NQF Clarifies its Conflicts of Interest Policies

As reported by Modern Healthcare, it took only a day for the NQF to issue yet another press release to clarify its conflict of interest polcies.  In particular,

I n response to concerns that the community raised about the evidence base underlying Safe Practice #22 and Dr. Denham’s inordinate interest in this particular Safe Practice, NQF took the following steps in early 2010:

• Severed its relationship with Dr. Denham who has not been involved in any other NQF work since March 2010;
• Made a decision to refuse offers for financial support from Dr. Denham’s foundation, discontinuing a 2008 - 2013 grant agreement that had more than three years remaining ;
• Determined that it would not enter into grant agreements where the funder is on the endorsement committee, even as a non-voting member;
• Reviewed committee reports that Dr. Denham was involved in to be certain that he did not influence their outcome; NQF staff believe that he did not; and
• Updated and enhanced its conflict of interest policy – in 2010 and again in 2013;

So NQF appeared to react ad hoc to concerns that Dr Denham was too avid about the use of a particular product.  Its response included strengthening its COI policy and banning one particular type of conflict, receiving funding from an organization controlled by a member of a standard writing committee.  However, as we noted above, the 2013 policy still has its weaknesses.  

Furthermore, an NQF executive volunteered to inform me that while the current written COI policy does not require public disclosure, in practice the organization requires public verbal disclosure of conflicts at the beginning of each committee meeting, and that the transcripts of these disclosures are available on the organization's website.  However, how to reach these disclosures is not obvious, and I so far have not been able to find the transcript that supposedly contains the disclosures for the meeting which Dr Denham co-chaired


Summary and a Few Optimistic Thoughts (Rare as They are for Us)

What I must say is now most unusual in the CareFusion/ Dr Denham/ NQF case is that NQF leadership, rather than  hunkering down in a defensive posture we have seen many other leaders adapt, seems to be trying to take steps toward addressing problems posed by conflicts of interest affecting its standard setting, guideline development, and quality assurance.  First, it is clear that NQF leaders did react to concerns about Dr Denham, and did somewhat tighten up their conflict of interest policies in response to them.  Second, it is clear that they are willing to listen to public questions and criticism, and at least consider further change in response to them.  They thus appear far more open than do leaders of many other organizations.

IMHO, NQF leadership is to be congratulated for this more transparent approach.  If only the leaders of other health care organizations would do as much. 

Since they do seem open to criticism and change, in the spirit of constructive criticism, I do hope that NQF leaders might also consider:
-  further strengthening their conflict of interest policy for standard setting committees, particularly by minimizing the number of committee members with conflicts, and banning individuals with conflicts from chairing committees, as per the IOM report on standards for trustworthy clinical practice guideline development
-  increasing transparency about conflicts of interest, particularly by making disclosures for all projects available without complex web searching
-  decreasing institutional conflicts of interest by refusing funding from health care corporations whose revenues might be affected by the content of standards and guidelines, and reducing conflicts affecting NQF board members and executives

Health care leaders who see transparency and reduction of conflicts of interest as important goals show us that true health care reform might actually be possible.

ADDENDUM (24 January, 2014 - I was told that many people may need an explanation of the title.  "Putting in the ski lifts" is a shortened version of an old college saying.  The location for the ski lifts was a place that is traditionally very hot, think fire and brimstone.  The phrase refers to an extremely improbably event.  Sorry about any confusion.