healthy4u: CareFusion

The Implications of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group Case Continue to Grow, but Remain Anechoic

The story about CareFusion, Dr Charles Denham, and the National Quality Forum certainly has legs, but continues to tread very softly.  Background At the time of our <a href="http://hcrenewal.blogspot.com/2014/01/the-carefusion-denham-nqf-case-plot.html">last post</a>, on January 28, 2014, the basics 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 <a href="http://www.carefusion.com/medical-products/carefusion-brands/chloraprep/">ChloraPrep</a>, a solution meant for preoperative and other health care skin cleaning -  The Department of Justice <a href="http://www.justice.gov/opa/pr/2014/January/14-civ-021.html">news release</a> 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 to prevent surgical site infection written by the committee allegedly included the use of ChloraPrep, although mention of that specific medication was removed in a revision -  The Department of Justice alleged that the standard was based on a journal article sponsored by Cardinal Health, from which CareFusion split, and which may have been manipulated by its sponsor -  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. - Despite these efforts by the NQF to remove excess influence by Dr Denham, a specific recommendation to use ChloraPrep, specified by formula but not by name, did appear in another NQF standard, one for preventing central line infections; the NQF logo apparently appeared on at least one educational event run by Dr Denham that advocated the use of ChloraPrep; and CareFusion cited NQF support in at least one promotional brochure Dr Denham's Previous Associates Now Have Doubts According to an <a href="http://www.healthleadersmedia.com/print/QUA-300562/Patient-Safety-Orgs-Cut-Ties-With-Denham">article</a> in Health Leaders Media, Dr Denham was associated not only with the NQF, but also another well known organization that promotes patient safety, the Leapfrog Group.  Since the CareFusion settlement was made public, this association has come to an end: <blockquote class="tr_bq">Denham was appointed to Leapfrog's Safe Practices Committee as Chairman in 2006. 'The position represented a voluntary commitment with no financial or contractual relationship between Dr. Denham and Leapfrog,' says a Leapfrog statement. On Wednesday, Denham resigned his position from the committee 'to make sure the present distraction does not impact you or the work you do.' The group accepted his resignation on Thursday. Leapfrog's president and CEO, Leah Binder, said in an interview with HealthLeaders Media: 'We've never taken any money from him and we have no contracts with him.' Leapfrog has asked Denham and his company, TMIT, to 'remove any language from its website implying Leapfrog endorsement of 'test beds,' as this is not authorized. Further have TMIT remove any reference to a Leapfrog Hospital Survey 'flight simulator,' as this authorization was only given in 2006 and expired in 2007.' On Thursday, Binder issued a statement saying her board 'was concerned with Dr. Denham's failure to reveal to the National Quality Forum or Leapfrog his potentially compromising relationship with CareFusion, which demonstrated a lack of transparency inconsistent with our organization's core values and mission.' </blockquote>Note that the Leapfrog group charged that Dr Denham failed to disclose his financial relationships with CareFusion to them.  The article also implied that Dr Denham was falsely claiming that the Leapfrog Group had endorsed various activities by his Texas Medical Institute of Technology.  So it appears that Dr Denham's efforts to conceal his conflict of interest - and that is likely an understatement of his relationship with CareFusion -  and to make it appear that prestigious patient safety organizations supported CareFusion products were more widespread than we initially realized.  Furthermore, a <a href="http://community.the-hospitalist.org/2014/01/30/patient-safetys-first-scandal-the-sad-case-of-chuck-denham-carefusion-and-the-nqf/">post</a> by Dr Robert Wachter on his blog Wachter's World noted  <blockquote class="tr_bq">In retrospect – always in retrospect – it should have been obvious that, when it came to Dr. Charles Denham, something was not quite right.</blockquote> He admitted that many aspects of the National Quality Forum's and his relationship with Dr Denham were in retrospect questionable.  These included the obscurity of the sources of the lavish resources that Dr Denham's organizations commanded and the wealth that Dr Denham displayed. <blockquote class="tr_bq"> 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 <a href="http://en.wikipedia.org/wiki/Charles_Denham" target="_blank">former radiation oncologist</a>. 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 '<a href="http://www.safetyleaders.org/pages/idPage.jsp?ID=2034" target="_blank">research test bed</a>,' 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,...</blockquote> Another concern in retrospect was how Dr Denham became editor of a journal on patient safety: <blockquote class="tr_bq">The <a href="http://journals.lww.com/journalpatientsafety/pages/default.aspx" target="_blank">Journal of Patient Safety</a> 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 <a href="http://www.newswise.com/articles/dr-charles-denham-named-editor-of-journal-of-patient-safety" target="_blank">named a new editor</a>. 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.</blockquote> Finally, Dr Wachter recounted that many of his professional colleagues ended up involved with Dr Denham, often with doubts, but doubts upon which they did not act, <blockquote class="tr_bq">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 <a href="http://en.wikipedia.org/wiki/Peter_Pronovost" target="_blank">Peter Pronovost</a>, 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.'</blockquote> Again, it appears that Dr Denham's deceptions may have been considerably larger than indicated by the initial reports. Senator Grassley Now Has Questions The redoubtable Senator (R - Iowa), who is known to be particularly vigilant about conflicts of interest in health care, has now officially stepped in.  According to an <a href="http://www.propublica.org/article/senator-cites-serious-concerns-demands-national-quality-forum-records">article</a> in ProPublica,  <div class="article"> <blockquote class="tr_bq">An influential senator is demanding copies of contracts and conflict-of-interest policies from the National Quality Forum after allegations that kickbacks were paid to influence its patient safety guidelines. Sen. Charles Grassley cited 'serious concerns' about how the Quality Forum vets its expert advisers and suggested the group may have endorsed a drug for a use the government hasn’t approved. </blockquote> The NQF is in this hot seat because it gets extensive US government support, <blockquote class="tr_bq">In 2012, three-fourths of the Quality Forum’s $26 million in income came from the government to endorse health care quality measures and evaluate spending. It’s expected to receive about <a href="http://www.propublica.org/documents/item/1010669-gao-2012-nqf-report#document/p9/a142562">$10 million</a> from the federal government this year under provisions of the Affordable Care Act. </blockquote> The group promised a swift reply, <blockquote class="tr_bq">Spokeswoman Ann Greiner said the Quality Forum will promptly reply to Grassley. The group already had announced a new, 30-day review of its guidelines and policies after ProPublica raised questions about ChloraPrep last month. 'As you know, we fully cooperated with the DOJ inquiry, and have our own review of NQF processes (including conflict of interest policies) related to the 2010 Safe Practices report under way,' Greiner said in an email, referring to the group’s latest patient safety guidelines.</blockquote> More Questions about How Dr Denham May Have Tried to Influence the NQF to Promote ChloraPrep The latest <a href="http://www.modernhealthcare.com/article/20140204/NEWS/302049952/journal-investigates-allegations-of-tainted-research-as-denham">article</a> by Joe Carlson for Modern Healthcare raised a question about how Dr Denham knew the results of the New England Journal of Medicine article at the time he alluded to its findings at an NQF meeting, <blockquote class="tr_bq">The NQF committee's discussion of the study took place in <a href="http://www.modernhealthcare.com/assets/pdf/CH9291524.PDF">August 2009 (PDF)</a>, and the results of the clinical trial comparing alcohol-chlorhexidine versus traditional iodine-based surgical antiseptics didn't appear in print in the New England journal until <a href="http://www.nejm.org/doi/pdf/10.1056/NEJMoa0810988">January 2010</a>. Journals typically prohibit release of data in peer-reviewed studies before publication.</blockquote> The article also underscored a question raised by Senator Grassley <blockquote class="tr_bq">Grassley contends that CareFusion didn't even have <a href="http://www.modernhealthcare.com/section/articles?tagID=1136">Food and Drug Administration</a> approval for that specific indication of ChloraPrep at the time the NQF was talking about it. 'It is concerning that a prominent expert at NQF was encouraging non-approved uses during a review of patient safety best practices while being paid millions of dollars by the manufacturer of ChloraPrep,' <a href="http://www.modernhealthcare.com/assets/pdf/CH9291624.PDF">Grassley wrote in a letter Monday (PDF)</a> to <a href="http://www.modernhealthcare.com/section/articles?tagID=856">NQF President and CEO Dr. Christine Cassel</a>.</blockquote> The list of questions about possibly deceptive practices by Dr Denham that could have promoted his pay-master CareFusion's products continues to grow, as does the scope of the apparent influence of his actions.  While this case includes many elements familiar to Health Care Renewal readers, such <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">individual</a> and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a>, <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a> and other aspects of <a href="http://hcrenewal.blogspot.com/search/label/health%20care%20corruption">health care corruption</a>, <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation of clinical studies</a>, questionable <a href="http://hcrenewal.blogspot.com/search/label/guidelines">clinical practice guidelines</a>, and <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> marketing practices, the scope of the case is becoming extraordinary.  It now involves at least two respected non-profit organizations that promote health care safety and quality, two medical journals, many respected medical academics, and an undetermined number of hospitals.  Summary - Where are the Echoes? It is heartening that leaders of the NQF have responded to this case openly, and without some of the defensiveness we have often seen when questions are raised about the actions of important health care organizations.  It is also heartening that at least one US Senator has taken an interest.  Yet despite its  scope and the potential importance of these reactions to it, this case has remained relatively anechoic. We have often, but not so much lately, discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>.  Cases, issues and ideas that might raise questions about the powers that be in health care, or might offend or threaten those who profit the most from the our dysfunctional health care system often have few echoes in the mainstream media and the medical, health care and health policy literature.  While the CareFusion/ Dr Denham/ National Quality Forum/ Leapfrog Group case seems like it ought to be very important, and many writers have now addressed it, so far it has only been covered by relatively obscure outlets.  Although initial brief coverage of the CareFusion settlement appeared in business news services like Reuters, all coverage since has been in Modern Healthcare, ProPublica, Health Leaders Media, and several blogs, including Health Care Renewal. Presumably this is the reason another blogger, in the <a href="http://commonhealth.wbur.org/2014/02/patient-safety-scandal">WBUR CommonHealth blog</a>, wrote ironically, <blockquote class="tr_bq">Paging Dr. Atul Gawande, paging Dr. Atul Gawande. Please call your assigning editor at The New Yorker to discuss the scandal around the $11 million that the company CareFusion allegedly paid to a leading figure in the patient safety field who pushed the company’s surgical antiseptic. I confess, that’s just my fantasy, that Dr. Gawande — prominent himself in patient safety as author of '<a href="http://atulgawande.com/book/the-checklist-manifesto/">The Checklist Manifesto'</a> — might want to take on this assignment. </blockquote></div><div class="article"> </div><div class="article">So it appears the anechoic effect is still with us. When leaders of big health care organizations enjoy ever increasing pay and influence, and the organizations they lead become ever more dominant, the risk of causing them offense continues to grow.  So it is all to easy to choose to ignore what might trouble the new health care plutocracy. But if no one notices the emperor has no clothes, he will continue to march around naked. </div><div class="article"> </div><div class="article">by Roy M Poses MD for Health Care Renewal </div>

The Implications of the CareFusion/ Dr Denham/ NQF/ Leapfrog Group Case Continue to Grow, but Remain Anechoic

The story about CareFusion, Dr Charles Denham, and the National Quality Forum certainly has legs, but continues to tread very softly. BackgroundAt the time of our last post, on January 28, 2014, the b…

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05 Feb 2014

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 <a href="http://hcrenewal.blogspot.com/2014/01/putting-in-ski-lifts-national-quality.html">here</a>, 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 <a href="http://www.carefusion.com/medical-products/carefusion-brands/chloraprep/">ChloraPrep</a>, a solution meant for preoperative and other health care skin cleaning -  the Department of Justice <a href="http://www.justice.gov/opa/pr/2014/January/14-civ-021.html">news release</a> 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 <a href="http://www.modernhealthcare.com/article/20140125/MAGAZINE/301259961">Modern Healthcare</a>, the <a href="http://commonhealth.wbur.org/2014/01/patient-safety-scandal-carefusion">WBUR CommonHealth blog</a>, and on <a href="http://www.propublica.org/article/hidden-financial-ties-rattle-top-health-quality-group">ProPublica</a>.  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, <blockquote class="tr_bq">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.</blockquote> Also, <blockquote class="tr_bq">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 <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">it was ended three years early</a>, in 2010, after concerns about Denham emerged. </blockquote> Not only did the non-profit help fund the NQF, it was directly involved in relevant NQF activities, <blockquote class="tr_bq">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. </blockquote>  Furthermore, while the NQF asks committee members to disclose conflicts of interest verbally at the start of each meeting, again according to ProPublica, <blockquote class="tr_bq">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.'</blockquote> 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, <blockquote class="tr_bq">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.</blockquote> Also, per an interview with Brian Johnson, publisher of MassDevice.com, WBUR reported: <blockquote class="tr_bq">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.</blockquote> Thus, it appears that this study may have been <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> (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, <blockquote class="tr_bq">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. </blockquote> However, according to ProPublica things were even more complicated.  Denham promoted ChloraPrep in not one, but two instances, <blockquote class="tr_bq">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</blockquote> The final report did delete the specific reference to ChloraPrep as the preferred method for preparing surgical sites, <blockquote class="tr_bq">.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. </blockquote> However, the final report did appear to endorse ChloraPrep for reduction of central line infections, <blockquote class="tr_bq"> 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. </blockquote> Also, again per ProPublica, the NQF seemed to have been roped into other efforts run by Dr Denham to promote ChloraPrep, <blockquote class="tr_bq">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, <a href="http://www.safetyleaders.org/downloads/WebinarNQFSafePractices_PanelistSlides_Feb_18_2010_Handout.pdf">posted on the website</a> 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 <a href="http://www.carefusion.com/pdf/Interventional_Specialties/Thora-Para_catheter_drainage_system_brochure-IS2391.pdf">on its website</a>.</blockquote> 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 <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> 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 <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and/or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> 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 <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional</a>, 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.

The CareFusion/ Denham/ NQF Case - the Plot Thickens

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28 Jan 2014

Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">march of legal settlements</a> turns out to be more interesting than it first appeared. The Basic Story: Off-Label Marketing  The story was initially briefly reported in the media.  A <a href="http://blog.seattlepi.com/boomerconsumer/2014/01/09/company-to-pay-40-1-million-to-settle-medicaid-fraud-kickback-charges/">report</a> in the Seattle Post-Intelligencer on 9 January, 2014, was perhaps the most complete, <blockquote class="tr_bq">CareFusion, a manufacturer of medical and surgical supplies and medical devices, has agreed to settle charges of illegal marketing practices and kickback payments for promoting sales of the company’s surgical preparation solution, Chloraprep. Under the terms of the settlement with Washington, other states, and the federal government, CareFusion will pay a total of $40.1 million.</blockquote> In particular,   <blockquote class="tr_bq">When the FDA approves a surgical solution such as Chloraprep as safe and effective, its manufacturer can’t market or promote it for an 'off-label' use – any use not approved by the FDA. Chloraprep was approved for specific inpatient hospital procedures, including the preparation of a patient’s skin prior to surgery or an injection. The FDA rejected its use for prepping the skin prior to inserting catheters into veins for administering medications, or cleaning the skin as part of closing wounds. The lawsuit alleges that from Sept. 1, 2009 to Aug. 31, 2011, CareFusion promoted Chloraprep for improper uses. CareFusion also allegedly publicized unverified information about Chloraprep during the same time period, Ferguson said.</blockquote> So this follows a template we have seen before, most recently <a href="http://hcrenewal.blogspot.com/2014/01/more-pharmaceutical-misadventures.html">here</a>.  A company promotes a drug or device for "off-label" uses.  While physicians are legally allowed to prescribe a drug or use a device for reasons other than its official indications, companies are not legally allowed to promote such uses.  Sometimes it turns out that the drug has benefits that outweigh its harms when used off-label, in which case the violation could be considered technical.  In other cases, the drug might turn out to be useless or even net harmful when used off-label, so the violation indicates putting revenue ahead of patients' welfare.   The reporting on the CareFusion Chloraprep settlement did not clearly suggest that the off-label use was harmful to patients. Allegations of Kickbacks to Promote Off-Label Use, but How? It gets more interesting.  The Post-Intelligencer also noted, <blockquote class="tr_bq">The states also contend that in 2008 CareFusion’s predecessor corporation entered into agreements that CareFusion assumed legal and financial responsibility for. This included payments to Health Care Concepts Inc., payments that were allegedly made to hide kickbacks to the physician-owner of HCC for promoting and influencing providers to use Chloraprep, he said. This violates federal and state anti-kickback laws.</blockquote> Now the allegations also include kickbacks to the "physician-owner" of a company to facilitate off-label promotion.  So the issue goes beyond a technical violation of the law.  The Post-Intelligence report, however, did not make clear what Health Care Concepts Inc actually did to contribute to off-label promotion. A quick attempt to find out more about this company via the web was not fruitful.  There are lots of companies/ organizations called Health Care Concepts or some variant.  The most relevant may be<a href="http://www.hcc1.com/"> this one</a>, which lists CareFusion as a "partner" on its main web-page.  What this company actually does is a bit unclear.  Its business model is <a href="http://www.hcc1.com/node/3">described</a> as "a private incubator of early products, services, and technologies, as well as an accelerator of mature solutions that will be taken to scale." What that has to do with off-label promotion of a product of a big established company like CareFusion is not clear.  How this company could have influenced providers is not clear, given that it is not an advertising firm, public relations firm, or medical education and communication company (MECC). So what is going on here?   Allegations of a $11.6 Million Payment to Manipulate the National Quality Forum Standards Yesterday, 21 January, 2014, Modern Healthcare began to <a href="http://www.modernhealthcare.com/article/20140120/NEWS/301209952/nqf-committee-member-paid-11-6m-by-carefusion-to-influence-panels">explain</a> the mystery.    <blockquote class="tr_bq">Many healthcare companies have been accused of paying kickbacks to influence physicians' medical decisions, but one major supplier allegedly tried to steer an entire industry by influencing the recommendations of the National Quality Forum The NQF, which reviews medical evidence and makes recommendations for improving healthcare, acknowledges that a well-known patient safety advocate is alleged to have received millions of dollars to promote a surgical sterilization product while co-chairing an NQF committee that suggested hospitals use that product.  Federal officials say Dr. Charles Denham, co-chair of NQF's Safe Practices Committee in 2010, received $11.6 million from San Diego-based CareFusion to promote the company's ChloraPrep line of skin-preparation products. Denham's committee at the NQF also recommended surgeons use ChloraPrep products to prevent surgical infections, the NQF said. </blockquote> The allegations about the role of Dr Denham in the NQF also did appear in the the official US Department of Justice <a href="http://www.justice.gov/opa/pr/2014/January/14-civ-021.html">press release</a>. Allegations of Bogus Contracts, and Non-Denial Denials The allegations produced some <a href="http://en.wikipedia.org/wiki/Non-denial_denial">non-denial denials</a> (in the phrase found in All the President's Men). Dr Denham responded, but through a lawyer: <blockquote class="tr_bq">A statement from Denham's attorney, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, said reports that the underlying lawsuit involved Dr. Denham were 'blatantly false.' Denham was not accused of wrong-doing in the whistleblower lawsuit, and Gondelman said Denham has and continues to cooperate with investigators in the case.</blockquote> Note that while the attorney denied that Dr Denham was named in the underlying lawsuit, he did not apparently specifically deny the allegations. The NQF also reponded, <blockquote class="tr_bq"> An NQF review committee removed the reference to the specific product before final publication of '<a href="http://www.qualityforum.org/Publications/2010/04/Safe_Practices_for_Better_Healthcare_%E2%80%93_2010_Update.aspx">Safe Practices for Better Healthcare</a>' in 2010. 'An NQF ad hoc review did not find sufficient evidence to support one skin preparation over another,' <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">a statement from the organization said</a>. 'The ad hoc review effectively served its role of rapidly responding when a potential issue is identified.'</blockquote> Note that the <a href="http://www.qualityforum.org/News_And_Resources/Press_Releases/2014/NQF_Statement_on_Department_of_Justice_Settlement.aspx">NQF press release</a> did not deny that the CareFusion money was given to Dr Denham's organization, nor that the NQF report might have promoted the use of a class of products in which CareFusion's Chloraprep resides. A <a href="http://www.modernhealthcare.com/article/20140121/NEWS/301219952/nqf-panel-member-admits-he-got-11m-from-carefusion-but-calls">follow-up story</a> in Modern Healthcare noted that Dr Denham confirmed the payment of the money to his company, but not its purpose, <blockquote class="tr_bq"> Renowned quality expert Dr. Charles Denham confirms that CareFusion paid his company more than $11 million, but Denham says he was surprised to see the U.S. Justice Department describe the money as kickbacks intended to influence national quality-of-care guidelines published by the National Quality Forum.</blockquote> Dr Denham's lawyer confirmed the payment, but did not further explain it: <blockquote class="tr_bq">Denham's lawyer, Larry Gondelman of Powers Pyles Sutter & Verville in Washington, acknowledged that CareFusion did pay Denham's company under two contracts. </blockquote> And, <blockquote class="tr_bq">Gondelman said the $11.6 million paid to Denham's company covered 'an array of services' and that he could not elaborate.</blockquote> Again, note that Mr Gondelman did not specifically deny that the money served as a kickback. Meanwhile, the Department of Justice alleged something more elaborate, and nefarious,  <blockquote class="tr_bq">The Justice Department, though, says the contracts were written to look as though CareFusion was buying consulting, software development and strategic marketing services, as well as the completion of three unnamed projects. The value of the deals, the government alleges, far exceeded the fair-market costs of those services, and that one of the actual purposes of the deals was to conceal kickbacks to Denham while he served on the National Quality Forum.</blockquote> Interval Summary So what is clear so far is that: -  CareFusion agreed to a $40.1 million settlement of allegations that it provided kickbacks to promote off-label use of its product. -  CareFusion paid $11.6 million to Health Care Concepts -  Health Care Concepts is run (and possibly owned) by Dr Charles Denham, who chaired a National Quality Forum committee that recommended use of CareFusion's product ChloraPrep in a performance standard and the final version of the NQF standard recommended use of a group of products including ChloraPrep We have frequently discussed how health care corporations may promote goods, particularly drugs and devices and services through <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> and unethical practices, including inducements ranging form creation of <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> to outright <a href="http://hcrenewal.blogspot.com/search/label/bribery">bribes </a>and <a href="http://hcrenewal.blogspot.com/search/label/kickbacks">kickbacks</a>.   We have also discussed the influence of individual and <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a> on <a href="http://hcrenewal.blogspot.com/search/label/guidelines">clinical practice guidelines</a>.  This has become an important enough problem for the US Institute of Medicine to weigh in with <a href="http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust.aspx">standards for trustworthy guidelines</a> that markedly limit such conflicts of interest.  This case seems notable because it may link the problems of <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> and unethical promotion with the influencing of clinical practice guidelines.  It is particularly notable because the organization generating the guidelines in question, the National Quality Forum, has become large, influential, and authoritative.  Re the latter point, the latest Modern Healthcare article affirmed, <blockquote class="tr_bq">The NQF is a standards-setting organization for the healthcare provider industry. It holds the exclusive contract to provide Medicare and Medicaid with recommendations on a national quality-of-care strategy and the measures used to gauge improvements.</blockquote> In fact, while the NQF performance standards can function as guidelines, they also may be bases for <a href="http://hcrenewal.blogspot.com/search/label/pay%20for%20performance">pay for performance</a> schemes that attach real incentives to guidelines, which could become <a href="http://hcrenewal.blogspot.com/search/label/perverse%20incentives">perverse</a> if the guidelines have been manipulated. Can the NQF Defend Against Conflicts, and If Not, Should it Remain So Authoritative? So the big question is whether the NQF, given its unique influence, has any meaningful approach to prevent its standards from being influenced by conflicts of interest? The NQF does have a <a href="http://www.qualityforum.org/docs/CDP_Conflict_of_Interest_Policy.aspx">recent conflicts of interest policy</a>. However, according to my reading, it neither bans committee members with conflicts of interest, nor even requires public disclosure of conflicts of interest.  All it seems to require is that committee members disclose conflicts internally and <strike>voluntarily</strike> recuse themselves from deliberations which may be affected by them.  Although the policy states that conflicts of interest may be made public, I could find nothing in the <a href="http://www.qualityforum.org/Publications/2010/04/Safe_Practices_for_Better_Healthcare_%E2%80%93_2010_Update.aspx">report</a> which Dr Denham co-authored about conflicts of interest or competing interests affecting any of the authors, including Dr Denham Furthermore, a very quick look at information publicly available on the NQF web-site suggests the organization itself may have major institutional conflicts of interest.  The NQF is one of those "public-private partnerships" that have become all the rage.  Several members of its <a href="http://www.qualityforum.org/About_NQF/Board/Board_of_Directors_Roster.aspx">board of directors</a> have leadership positions in large health corporations, financial firms with large health care interests, or trade associations for large health care corporations:  <a href="http://www.qualityforum.org/About_NQF/Board/Elizabeth_Fowler.aspx">- Elizabeth J. Fowler</a>, PhD, JD, is Vice President, Global Health Policy, in the Government Affairs & Policy group at Johnson & Johnson. - <a href="http://www.qualityforum.org/About_NQF/Board/Robert_Galvin.aspx">Robert Galvin</a>, MD, is Chief Executive Officer, Equity Healthcare, at The Blackstone Group.  - <a href="http://www.qualityforum.org/About_NQF/Board/Karen_Ignagni.aspx">Karen Ignagni</a>, President and Chief Executive Officer of America’s Health Insurance Plans (AHIP), is the voice of health insurance plans.... - <a href="http://usa.healthcare.siemens.com/infrastructure-it/healthcare-it/about-health-services/leadership-profile-healthcare-it">J Mark Overhage</a> MD, PhD,  Chief Medical Informatics Officer, Health Services, Siemens Healthcare Thus it is conceivable that they could personally profit, and that their organizations could institutionally profit from standards that favor their organizations' interests.   Furthermore, NQF receives <a href="http://www.qualityforum.org/About_NQF/Funding.aspx">funding</a> from the US government and private foundations, but also from pharmaceutical companies and their in-house foundations: <blockquote class="tr_bq">the Bristol-Myers Squibb Foundation, the Cardinal Health Foundation, Pfizer Inc., Sanofi-aventis,...</blockquote> Unless the current case leads to big changes in the prevalence of conflicts of interest among the NQF board, the continuation of its institutional conflicts of interest generated by its sources of funding, and its weak policy on conflicts affecting committee members, the question becomes whether it should continue to have such an authoritative role? As we have said over and over, pervasive conflicts of interest affect health care decision-makers and policy makers and the organizations within which they function.  Such conflicts threaten to put various private interests way ahead of patients' and the public's health.  If we really want health care that will put patients' and the public's health first, we need to end such arrangements that favor private gain.    Roy M. Poses MD on Health Care Renewal ADDENDUM (23 January, 2014) - A closer re-reading of the NQF conflict of interest policy made it clear that recusal is not voluntary, and that conflicts of interest may be revealed publicly, but that such disclosure is not mandatory.  The paragraph above dealing with these issues was revised accordingly.

Our Man in the NQF? - CareFusion Settles Kickback Allegations for $40.1 Million and Government Alleges They Meant to Manipulate National Quality Forum Standards

What appeared to be yet another entry in the march of legal settlements turns out to be more interesting than it first appeared.The Basic Story: Off-Label Marketing The story was initially briefly re…

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22 Jan 2014

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