"Can't This be Avoided?" - How Corporate Marketers Manipulated a Clinical Research Report to Avoid "Undermining" Marketing Messages

Documents newly made public in the course of litigation about the drug Pradaxa show granular details about how clinical research may be manipulated by corporate research sponsors intent on marketing their products.<br /><br /><b>Background</b><br /><br />As <a href="http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html">reported</a> by the New York Times, the litigation is over allegations by thousands of patients and families that privately held Boehringer Ingelheim concealed the bleeding risks of the anticoagulant drug Pradaxa.  <br /><br /><blockquote class="tr_bq">Pradaxa and two other recently approved drugs, Xarelto and Eliquis, are in a race to gain market share from warfarin, a generic drug that for decades has been the standard treatment for preventing blood clots and strokes. Many patients viewed the older warfarin as a nuisance because it requires frequent blood tests and careful attention to diet and other drugs.<br /><br /><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody">The new drugs do not require such monitoring, yet claim to be as good, or better, at preventing strokes and blood clots in patients with a heart-rhythm disorder known as atrial fibrillation.</div></blockquote><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody">However,</div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"></div><div class="story-body-text story-content" data-para-count="190" data-total-count="2310" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="180" data-total-count="747" itemprop="articleBody">Since its approval in 2010, the drug, <a href="http://www.nytimes.com/2012/11/03/business/a-rising-anti-stroke-drug-is-tied-to-risk-of-bleeding-deaths.html" title="From the archives.">which can cause fatal bleeding</a>, has brought in more than $2 billion in sales in the United States, according to the research firm IMS Health. </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">It has been prescribed to 850,000 patients, but has also been linked to more than 1,000 deaths. </div></blockquote><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><b>Internal Documents Show the Influence of Marketers on a Clinical Research Report</b></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">As summarized by the NY Times, </div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> The makers of the blood-thinning drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents.</div></blockquote><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody">In particular,</div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="96" data-total-count="843" itemprop="articleBody"> </div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="463" data-total-count="2773" itemprop="articleBody">The documents show that Boehringer Ingelheim employees <i>openly fretted when it appeared that the results of the research paper, written by Paul A. Reilly, a clinical program director at the company, indicated that some patients could benefit from monitoring of their blood</i>. A certain segment of patients, the paper found, absorb too little of the drug to effectively prevent strokes, while another group absorbs so much that they are at a higher risk for bleeding.</div><div class="story-body-text story-content" data-para-count="463" data-total-count="2773" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="272" data-total-count="3045" itemprop="articleBody"><i>In a draft version of the paper included in the court records, Dr. Reilly and his co-authors detailed specific levels of how much Pradaxa should be in a patient’s bloodstream, and said that keeping some patients within that range would help prevent strokes and bleeding.</i></div><div class="story-body-text story-content" data-para-count="149" data-total-count="3194" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="149" data-total-count="3194" itemprop="articleBody">As Dr. Reilly’s draft paper circulated within the company, some employees <i>questioned what the marketing implications</i> of such a conclusion would be.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="3463" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="269" data-total-count="3463" itemprop="articleBody">One company supervisor, Dr. Jutta Heinrich-Nols, wrote in an email to other employees that <i>she could not believe the company was planning to publish research that would negate a decade’s worth of work proving that patients taking Pradaxa would not need regular tests.</i></div><div class="story-body-text story-content" data-para-count="185" data-total-count="3648" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="185" data-total-count="3648" itemprop="articleBody">Publishing the research results, she warned, could <i>make it 'extremely difficult' for the company to defend its long-held position to regulators that Pradaxa did not require testing</i>.</div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody">And, Dr. Heinrich-Nols added in the email, the research, if known, would <i>'undermine' the company’s efforts to compete with other new anticoagulants, such as Xarelto and Eliquis.</i></div><div class="story-body-text story-content" data-para-count="183" data-total-count="3831" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> 'I would like to ask you to <i>check again whether this is really wanted</i>,' she wrote about publishing the research.</div></blockquote><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">A second NY Times <a href="http://www.nytimes.com/2014/02/08/business/new-emails-in-pradaxa-case-show-concern-over-profit.html">article</a> added more details,</div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"></div><div class="story-body-text story-content" data-para-count="176" data-total-count="2486" itemprop="articleBody">In one email, from June 2012, an employee wonders about the implications of internal research showing that blood levels of Pradaxa could vary significantly in a single patient.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody">'This may not be a onetime test and could result in <i>a more complex message (regular monitoring), and a weaker value proposition … vs. competitors,</i>' wrote the employee, whose name was redacted in accordance with privacy laws in Germany, where the company is based.</div><div class="story-body-text story-content" data-para-count="269" data-total-count="2755" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="453" data-total-count="3208" itemprop="articleBody">In another, an employee — whose name was also removed — asks about whether a newly available blood test in the United States might be useful for doctors treating patients with Pradaxa, which is also known as dabigatran. Another replies that such a test could be developed 'in-house,' but '2 years ago <i>there was an informed decision NOT to develop this</i>.' The employee continued, '<i>this would go against the ‘no monitoring’ idea/claim.'</i></div><div class="story-body-text story-content" data-para-count="453" data-total-count="3208" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="231" data-total-count="3439" itemprop="articleBody">Employees also continued to question the merits of allowing a research paper to be published showing that some patients could benefit from monitoring of their blood. The paper was <a href="https://content.onlinejacc.org/article.aspx?articleid=1748241&resultClick=24">published on Tuesday</a> but with some details removed.</div><div class="story-body-text story-content" data-para-count="231" data-total-count="3439" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="198" data-total-count="3637" itemprop="articleBody">'This publication will <i>more harm than be useful for us, neither in the market but be especially harmful in the discussions with regulatory bodies</i>,' one email read. '<i>Can’t this be avoided</i>?'</div></blockquote><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"> </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">So, in summary, Pradaxa has been marketed basically on its convenience, as a drug whose dosage need not be customized according to frequent blood tests, in contrast to cheaper generic warfarin whose dosage may need adjustment according to frequent blood tests.  Yet a clinical trail sponsored by Boehringer Ingelheim, the manufacturer of Pradaxa, seemingly showed that its risk of bleeding might be dependent on its blood level, and hence perhaps that its dosage <i>should</i> be varied according to blood test.  </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">However, the manuscript reporting the results of this trial was apparently subject to vetting by multiple company managers whose specific concerns were whether the results of this research "undermined" the marketing message, and hence whether these results should be changed or suppressed to avoid contradicting the company's intended marketing message.   </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">Let me try to add some context, based on my experiences in academic medicine writing research papers, commenting on colleagues' papers, and reviewing papers for journals.  Considerable discussion among the researchers and clinicians involved in research projects about how manuscripts are worded is the norm.  However, working a perhaps more innocent era, input from people with vested interests in the project producing a particular result was unheard of.  Many health care professionals thus may still act based on the idealistic assumption that clinical research reports are all about science, and not about marketing. </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><b>Was the Manipulation Successful?</b></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">A Medscape <a href="http://www.medscape.com/viewarticle/820324">article</a> noted that the published version of the research article </div><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody"><br /></div><blockquote class="tr_bq"><div class="story-body-text story-content" data-para-count="116" data-total-count="3947" itemprop="articleBody">found ischemic stroke and bleeding risks were correlated with plasma concentrations of the drug in 9183 patients treated with dabigatran 110 mg or 150 mg twice daily (the available European doses). In their logistic regression analysis, the risk of ischemic stroke was inversely associated with trough concentrations of dabigatran. </div><br />The researchers concluded that 'the magnitude of the effect of dabigatran plasma concentrations on outcomes in atrial-fibrillation patients in <b> <a href="http://www.medscape.com/viewarticle/708133" target="_blank">RE-LY</a> </b> depends strongly on demographic factors, most importantly increasing age.' However, the results also confirmed a wide therapeutic range among those treated with dabigatran, with a more than fivefold variation in plasma concentrations. The researchers concluded there might be a subset of patients who could improve their risk/benefit profile by tailoring the dose of dabigatran. </blockquote><br />However,<br /><br /><blockquote class="tr_bq">In the paper, <i>there are no references to the optimal plasma concentration of dabigatran,</i> although such statements were in various drafts that circulated throughout the company, according to the New York Times.  When the paper was published online in October, Reilly told Reuters news  that the 'there is no single plasma concentration range that provides optimal benefit-risk for all patients" and that "no monitoring is necessary.' [see relevant Medscape article <a href="http://www.medscape.com/viewarticle/812871">here</a>.]</blockquote><br />So it does appear that the final version of the article included a discussion that was influenced by the marketers' wishes that the results would not appear to contradict the marketing party line. <br /><br />A rigorous review of the article might have suggested that varying the dosage of the drug according to its blood level might reduce bleeding risk, and hence increase its benefits versus its harms.  However, a casual reading might not have revealed that the data in the study undermined the marketing message that Pradaxa is a better drug than warfarin because it can be given at a fixed dose without the need for inconvenient blood tests.  Thus, the efforts by the marketers to alter the dissemination of the clinical research to support marketing messages and increase sales of the drug and resulting revenues - never mind what the data showed - appeared to be successful. <br /><br /><b>Conclusions</b><br /><br />This case study, only made possible by the public release of internal corporate documents in the course of litigation, suggests that in retrospect the dissemination of the results of one particular clinical trial were manipulated in a somewhat subtle way so that the data would not contradict a marketing message that now appears rather fictional.<br /><br />In the absence of litigation, and of a judge willing to make public documents that one party to the litigation doubtless wanted to hide, the manipulation of this particular study might never have been apparent.  Most clinical research is now sponsored by health care corporations with vested interests in how the research turns out.  Much of this research could be manipulated by corporate marketers who wish it to support their marketing messages, the truth be damned.  We (and others) have discussed many <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">examples of apparent manipulation of clinical research</a>, <br /><br />However, it is unlikely that we, physicians, health care professionals, health care researchers and policy makers, and the public, will ever know for such which studies were manipulated.  At best, very critical, skeptical, rigorous review can suggest which studies might have been manipulated. In the absence of such review, we are in danger of being swamped in a morass of manipulated research, and thus lead to make clinical decisions that are based mainly on hucksterism, not science.<br /><br />Thus, I strongly advocate that those who author authoritative systematic reviews, meta-analyses, and clinical practice guidelines base their work on extremely rigorous, skeptical reviews that assume the likelihood that all commercially sponsored published clinical research has been manipulated (and that research that even post manipulation could not be twisted to support marketing many have been <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a>)  Reviews, meta-analyses, and guidelines that were not so based on extremely critical review should also be viewed with a jaundiced eye.  <br /><br />Perhaps it is possible to devise legal and regulatory methods to at least make such manipulation more transparent.  Maybe this case, however, should again suggest that clinical research, that is, research on human beings, should be completely separated from those with vested interests in selling products or services which could be better hyped were the research turn out in their favor. 

"Can't This be Avoided?" - How Corporate Marketers Manipulated a Clinical Research Report to Avoid "Undermining" Marketing Messages

Documents newly made public in the course of litigation about the drug Pradaxa show granular details about how clinical research may be mani...

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H.R.2957 and its proposal to limit eDiscovery of potentially admissible and material evidence in EHR-related medical disasters

Do computers have more rights than patients?<br /><br />It often appears that way to me. <br /><br />Health IT and its industry sector seem to garner extraordinary regulatory accommodations compared to other healthcare and life-critical sectors - such as freedom from meaningful safety regulation, freedom from need for human research subjects protections and informed consent on EHR risks ... and in this proposal, freedom from full legal Discovery:<br /><br />US Congress has a bill, <b>H.R.2957 - Behavioral Health Information Technology Act of 2013</b>, 113th Congress (2013-2014), at <a href="http://beta.congress.gov/bill/113th/house-bill/2957" target="_blank">http://beta.congress.gov/bill/<wbr></wbr>113th/house-bill/2957</a>) with a section (SEC. 4. <b>PROVIDING PROTECTIONS FOR CERTAIN PROVIDERS, VENDORS, AND USERS OF CERTIFIED EHR TECHNOLOGY</b>) that provides safe harbors for reporting EHR-related errors.<br /><br />The text of Sec. 4 contains this<span style="font-size: small;"><span style="font-family: inherit;">:</span></span><br /><br /><blockquote class="tr_bq"><span style="font-size: small;"><span style="font-family: inherit;">... (c) Rules Relating to E-Discovery.--In any health care lawsuit against a covered entity that is related to an EHR-related adverse event, with respect to certified EHR technology used or provided by the covered entity, electronic discovery <u><i>shall be limited to</i></u>--<br /><b>        (1) information that is related to such EHR-related adverse event; and<br />        (2) information from the period in which such EHR-related adverse event occurred.</b> </span></span></blockquote><br />In other words, it seems the bill proposes, on capricious grounds, that an injured party cannot discover any information from <u><i><b>prior</b></i><b><i> to</i></b></u><b> </b>- or <u><i><b>after</b></i></u> - the EHR-related event they allege caused their injury, even if potentially material; for example, if the cause of the event was known about and had occurred in the past to others, or afterwards, yet went uncorrected.<br /><br />This seems a shield against claims of EHR vendor and/or healthcare organization corporate negligence and seems to represent anther special accommodation to health IT.<br /><br />This proposed Bill would also, it seems, <b>hamper </b><i><b>clinicians</b> who were themselves victims of bad health IT </i>from fully defending themselves.<br /><br />How this Bill's eDiscovery infringement promotes timely correction of known EHR problems, I would like to know...<br /><br />I also fail to see what "certification" has to do with provision of this remarkable special accommodation regarding eDiscovery.<br /><br />"Certification" by HHS/ONC is a features qualification/verification of features felt by committee (with no real basis in Evidence-Based Medicine principles) to foster "meaningful use", whatever that means, and make an EHR product eligible for CMS incentives.<br /><br />However, "certification" is <b>not</b> a safety testing or validation process, in the words of the certification bureaus themselves, see my Feb. 2012 post <b>"Hospitals and Doctors Use Health IT at Their Own Risk - Even if 'Certified'"</b> at <a href="http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html">http://hcrenewal.blogspot.com/2012/02/hospitals-and-doctors-use-health-it-at.html</a>.<br /><br />Finally (and with the caveat that neither I nor my colleagues are lawyers), colleagues point out that such a proposal from Congress may be at odds with the role of the government branch that <i>does </i>decide the Rules of Civil Procedure, including discovery rules.  Specifically, the judiciary, at both the Federal court level (e.g., per the <span dir="auto"><b>Rules Enabling Act</b> of 1934, an Act of Congress that gave the judicial branch the power to promulgate the Federal Rules of Civil Procedure,  <a href="http://en.wikipedia.org/wiki/Rules_Enabling_Act">http://en.wikipedia.org/wiki/Rules_Enabling_Act)</a>, and State levels.</span><br /><span dir="auto"><br /></span><span dir="auto">It would seem quite possible that the roster of Congressional co-sponsors of this Bill, seen at <a href="http://beta.congress.gov/bill/113th/house-bill/2957/cosponsors">http://beta.congress.gov/bill/113th/house-bill/2957/cosponsors</a>, have been "influenced" by the health IT industry.</span><br /><span dir="auto"><br /></span><span dir="auto">-- SS</span>

H.R.2957 and its proposal to limit eDiscovery of potentially admissible and material evidence in EHR-related medical disasters

Do computers have more rights than patients? It often appears that way to me. Health IT and its industry sector seem to garner extraordinary...

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A Day In The Life Of A (Reluctant But Coerced) EHR-Using Physician - And Her Patients

A reader, a physician who wishes to be unnamed due to fear of retaliation, writes the following:<br /><br /><blockquote class="tr_bq">Dear Dr. Silverstein,<br /><br />As you write, there is not a transaction of medical care that does not go through EHR systems.<br /><br />However, these poorly usable EHR systems stifle creative and artistic thought required to link risk, benefit, and probability of diagnosis with risks and benefits of testing and therapeutics.<br /><br />Assuring safety and efficacy with pre- and  aftermarket surveillance will maximize the possibility of achieving the potential of the technologies.<br /><br />Additionally, when I use these electronic ordering systems and  libraries of medical information, they fail to keep up with the agility and nimbleness of my mind as I seek 'random access' to pieces of data to formulate and synthesize diagnoses and therapeutic strategies.<br /><br />The EHRs are too slow, do not have a robust (if any) search function, randomly and whimsically store key information with ever changing formats, and generally obfuscate what should be simple. They are cumbersome and disable the ability to simultaneously and contemporaneously compare myriad data points.<br /><br />They get an "F" as enablers of complex diagnostics.<br /><br />Paper, since it can be organized as needed and set out on a desk to be seen and compared as quickly as the eye registers the data, gets an "A".<br /><br />The EHRs  are impediments and disrupters of communication.<br /><br />Example: Just today, I was witness to the fact that a stat EKG was ordered by CPOE  on a heart patient yesterday at or shortly after 4:30 pm. The intended recipient of the order (heart station) never got it because they close near 4:30 pm and there was no warning to the ordering health professional that was so.<br /><br />Thus, the EKG was never done, and this morning, when the requisition was seen, no one did it because it was ordered stat "yesterday", and the techs asked themselves "what good would it do for a 'stat' to be done now, a day late?"<br /><br />I do not know what happened to the patient.  I have many other examples of such delays facilitated by the CPOE and EHR systems that I am required to use at numerous facilities.<br /><br />They facilitate 'stealth' alterations in care.  Also just today, a disease-critical test ordered 3 days ago was not done because it was cancelled in 'stealth' (automatically "expired") without warning to me by the lab responsible for doing it.<br /><br />There is the "silent silo" syndrome as you've called it.  Also just today, a disease critical test ordered 5 days ago came back with results, but the results were posted in the information 'silo' of 5 days ago. The lab screen default on the EHR only goes back 4 days (so unless I knew to look for it, it would not be seen or acted on), further obfuscating data and delaying treatment.<br /><br />The EHRs lose data and orders.  Also just today, I found that blood coagulation monitoring tests that were ordered to be done with kidney dialysis (3 days per week) on a patient somehow got "lost" and were not being done for 5 days, putting my patient at risk of bleeds - or stroke if the blood was not 'thin' enough.<br /><br />I just walked in to examine a hospitalized patient with multi-organ failure and diabetes, on multiple meds including insulin, and recovering from respiratory failure.<br /><br />The nurse anxiously informed me that the blood sugar was dangerously low. I ordered treatment stat.<br /><br />I see patients in the morning before labs come back, and depend on nurses to review labs and notify me.<br /><br />Turns out that the patient was hypoglycemic on yesterday morning labs that arrived in the EHR 'silo' after I left the hospital; and was also low in potassium, but the tests just laid there comfortable in their silos; and were not communicated to anyone like in the old days when a human ward clerk or other undistracted human received them and disseminated them to the appropriate professionals.<br /><br />Thus, instead of getting less insulin, the patient got the usual dose with near catastrophic adversity.<br /><br />Misidentifications are facilitated by EHRs.  I  noticed that on several critical clinically significant changes that arose on my patient that were entered as such in an EHR silo by the RN, it was stated that they called attending physician 'Dr X', which was not me...obviously a case of EHR-facilitated misidentification.<br /><br />Here is a misidentification variant:  yesterday, someone (non doctor but not clear who) ordered a specialist consultation on one of my patients under my name. I did not order it nor was it needed, yet it showed up as an order for me to sign.<br /><br />Like you, I agree this is representative of a toxic impact of these systems on medical care and I feel like the care environment is foul, like a cesspool, compared to what has been replaced.<br /><br />These systems of medical devices cannot be trusted in the care of sick patients. Perhaps, they are OK for managing hang nails.</blockquote><br />I offer no additional comments other then if I am sick, I do not want my care interfered with in this manner by IT. <br /><br />Rest assured, though - there are IT hyper-enthusiasts out there (<a href="http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html">http://hcrenewal.blogspot.com/2012/03/doctors-and-ehrs-reframing-modernists-v.html</a>) who would see little problem with this, as any accidents that occur are "anecdotes", "learning experiences" or "bumps in the road."<br /><br />That's if they don't simply blame the user.<br /><br />-- SS

A Day In The Life Of A (Reluctant But Coerced) EHR-Using Physician - And Her Patients

A reader, a physician who wishes to be unnamed due to fear of retaliation, writes the following: Dear Dr. Silverstein, As you write, there i...

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Who Knew? ... Judge Finds that Hospital Takeover of Medical Practices Raised Prices

A story that caused only a few ripples in the media in late January, 2014, corroborates concerns about the increasing concentration of power in health care, and suggests new skepticism about the continuing transition of physicians from independent professionals to corporate employees.<br /><br /><b>The Judge Quashes a Hospital System's Acquisition of Physicians' Practices</b><br /><br />The original story was carried, albeit briefly, in some national business news sources, e.g., the <a href="http://online.wsj.com/news/articles/SB10001424052702304856504579340733626090534">Wall Street Journal</a> and Bloomberg news.   In summary, according to the WSJ, <br /><br /><blockquote class="tr_bq">A federal judge ruled Friday that <i>an Idaho hospital system must unwind its acquisition of the state's largest independent doctor group</i>, a decision that could have significant implications as health-care providers nationwide increasingly seek to join forces.</blockquote><br />In particular,<br /><br /><blockquote class="tr_bq"> At issue was <i>St. Luke's Health System's 2012 deal for the 40-doctor Saltzer Medical Group</i>. The FTC argued the merger would r<i>educe competition among primary-care physicians and give St. Luke's extra muscle to extract higher payments from health plans</i>, which, in turn, could raise insurance prices for consumers.</blockquote><br />The Judge seemed to agree,<br /><br /><br /><blockquote class="tr_bq">U.S. District Judge B. Lynn Winmill<i> ruled the deal anticompetitive</i>, but offered comments that reflected current tensions in the debate over industry consolidation. <br /><br />Judge Winmill said he <i>was 'convinced' the deal would have improved the delivery of health care in the region</i>. But he ruled that 'there are other ways to achieve the same effect that do not run afoul of the antitrust laws and do not run such a risk of increased costs.'<br /><br />The judge said he would order St. Luke's to fully divest Saltzer's physicians and assets. <i>The court made only a summary of the ruling public, sealing the full decision temporarily so confidential business information can be redacted. </i></blockquote><br />Furthermore, the Bloomberg <a href="http://www.businessweek.com/news/2014-01-24/hospital-antitrust-case-won-by-u-dot-s-dot-over-doctor-group-merger-1">coverage</a> raised a related issue,<br /><br /><br /><blockquote class="tr_bq">David Balto, an antitrust lawyer in Washington who has represented consumer groups, said the ruling could be read as <i>conflicting with the Obama administration’s health care overhaul</i>, which advocates reducing fragmentation of medical care to improve quality. <br />'<br />This is going to raise really d<i>ifficult questions about the kind of integration</i> that’s envisioned by the Affordable Care Act,' he said.<br /><br />Winmill <i>didn’t specify alternate means of improving patient outcomes</i> and released only a summary of his ruling pending redaction of proprietary information in the full opinion. </blockquote><br /><br />Note several aspects to this coverage.  It implied that the deal was done solely for high-minded purposes, improving "health care delivery," and in response to the need for "integration" arising from the health care reform produced by the Affordable Care Act; that health care reform might be in jeopardy from this ruling in the absence of the judge's new prescription for "improving patient outcomes"; and that details of the ruling and the justification for it were kept secret as "confidential business information." <br /><br />So this initial coverage was difficult to interpret, raising more questions than it answered.  If the practice acquisition was made with such lofty goals, why couldn't it be legally saved?  How could health care reform possibly continue without Judge Winmill saying what should be done?  That last question was sarcastic, maybe the real question is why did anyone think it was the judge's job to explain how to improve health outcomes?  Finally, why was so much of the ruling and the details underlying it kept secret.<br /><br />In a few days, local journalists came up with a better idea of what was really going on.<br /><br /><b>It Was All About the Money</b><br /><br />The same day that the Wall Street Journal and Bloomberg covered the case, the Idaho Statesman <a href="http://www.idahostatesman.com/2014/01/24/2989492/federal-judge-says-st-lukes-buyout.html">reported</a> more details about the judge's ruling that seem to suggest different interpretations,<br /><br /><blockquote class="tr_bq">Winmill said in his ruling that while it may not have been the goal of the acquisition, it 'appears <i>highly likely that health care costs will rise </i>as the combined entity obtains a <i>dominant market position</i> that will enable it to (1) <i>negotiate higher reimbursement rates</i> from health insurance plans that will be passed on to the consumer, and (2) <i>raise rates for ancillary services</i> (like x-rays) to the higher hospital-billing rates.'</blockquote><br />Then only a week later, the Statesman <a href="http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html">covered </a>the unveiling of some previously hidden portions of the ruling, first giving the background,<br /><br /><blockquote class="tr_bq"> As St. Luke’s Health System aggressively added hospitals and doctors over the past several years, <i>it commanded more money from Idaho’s largest insurer, and it planned to raise prices in order to give a newly acquired group of doctors a 30 percent raise</i>, according to <a href="http://media.idahostatesman.com/smedia/2014/01/29/09/31/1fjNtG.So.36.pdf" target="_blank">newly released court documents</a>.<br /><br />Unsealed Tuesday, the documents explain why U.S. District Judge B. Lynn Winmill <a href="http://www.idahostatesman.com/2014/01/25/2990546/judge-st-lukes-deal-not-legal.html" target="_blank">last week ordered St. Luke’s to nullify</a> its year-old merger with Nampa’s Saltzer Medical Group.<br /><br /><i>Lawyers for St. Luke’s and Blue Cross of Idaho asked the judge not to reveal some facts</i> in the documents, arguing that they contained <i>trade secrets</i>. But Winmill <a href="http://media.idahostatesman.com/smedia/2014/01/29/09/35/1dSNod.So.36.pdf" target="_blank">denied the requests</a>.<br /><br />'The facts and figures sought to be redacted are crucial to the court’s analysis, and their removal would render the decision indecipherable,' Winmill said.</blockquote><br />Then it got to the nitty gritty,<br /><br /> Winmill said in his decision Tuesday to make his ruling public that when the trial started, he thought there were compelling reasons to keep parts of it veiled. But as it went on, those reasons seemed less compelling, he said.<br /><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html#storylink=cpy</div>Winmill immediately opened his entire decision.<br />  <br /><i>St. Luke’s told Winmill that he should keep statements such as the following out of his public ruling:</i><br /><ul><li> 'By 2012, St. Luke’s had <i>three of the top five highest-paid hospitals</i>, and its <i>top hospital was receiving reimbursements 21 percent higher</i> than the average Idaho hospital'</li><li> 'After the acquisition, if St. Luke’s were to bill for (routine services such as lab tests or X-rays) at the higher ‘hospital-based’ rates, (Blue Cross of Idaho) estimates that <i>costs ... would increase by 30 to 35 percent</i>.'</li><li> <i>'St. Luke’s own analysis</i> projected that it could <i>gain an extra $750,000 through hospital-based billing</i> from Saltzer from commercial payers for lab work and <i>$900,000 extra </i>for diagnostic imaging.'</li><li> 'Consultant Peter LaFleur prepared an analysis at the direction of St. Luke’s showing how <i>office/outpatient visits could be billed for higher amounts if the visit was hospital-based</i> rather than Saltzer-based. The hospital-based billings were more than 60 percent higher.' </li></ul><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html#storylink=cpy</div><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html#storylink=cpy</div><br /><br /><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.idahostatesman.com/2014/01/24/2989492/federal-judge-says-st-lukes-buyout.html#storylink=cpy</div> Although it certainly makes sense that the hospital system would want to know what the financial implications of buying the physicians' practices might be, the implication certainly seems to be that making a lot more money faster, in addition to any hopes for better patient outcomes, might be a goal of the merger.<br /><br /><br /><b>Trying to Keep Facts that Might Embarrass the Leaders out of Public View</b><br /><br />It is hard to understand why the hospital leadership was so fixated on keeping such information private if it were not to forestall any impression that this was all about the money.  As the Statesman reported,<br /><br /><br /><blockquote class="tr_bq">Much of the four-week trial happened <i>behind closed doors,</i> and <i><a href="http://www.idahostatesman.com/2013/10/18/2821968/hundreds-of-documents-in-st-lukes.html" target="_blank">many documents were sealed or heavily redacted</a></i>. Lawyers for the hospitals — and for insurance companies and local employers — marked those parts of the trial private because they said they <i>needed to protect trade secrets.</i><br /><br />St. Luke’s spokesman Ken Dey said <i>some underlying data from Blue Cross of Idaho on which Winmill based his decision was sealed,</i> and St. Luke’s lawyers could not access it. <i>St. Luke’s is concerned that data might have led to some 'misleading conclusions</i>,' he said.<br /><br />The <a href="http://www.idahostatesman.com/2013/11/13/2866737/statesman-other-news-groups-appeal.html" target="_blank">Statesman and several other Idaho news outlets <i>filed a lawsuit</i></a> to pry open the court proceedings, and that lawsuit is now before the U.S. Ninth Circuit Court of Appeals.</blockquote><br />It is obviously a matter of opinion whether revealing more information might have lead to misleading, or to accurate conclusions.  Note that local journalists were driven to file their own lawsuits just to gain access to records from a trial held in a government run court, and that many of those records are still secret.  <br /><br />It will be interesting to see the results of these further proceedings, but it seems much more likely that the hospital system leaders tried so hard to keep everything secret to protect their own images as only caring about "patient outcomes," not money.  If these were trade secrets, given that the hospital system seems to have become dominant in the market, from what competitors were they hiding?  <br /><div style="color: black; font: 10pt sans-serif; height: 1px; overflow: hidden; text-align: left; text-transform: none; width: 1px;"><br />Read more here: http://www.idahostatesman.com/2014/01/29/2997245/details-unveiled-in-st-lukes-case.html#storylink=cpy</div><br /><br /><b>Summary - Even More Reasons to be Concerned about Corporations Hiring Physicians to Take Care of Patients</b><br /><br />This case suggests some interesting conclusions which we hope are not misleading.<br /><br />Nationally or globally important health care issues are often still not well covered by national news media, much less the medical and health care literature.  Local journalists may doe a much better job, but local journalism is increasingly threatened.<br /><br />One reason important cases may be <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic</a> is that people involved with them fear public discussion of what may prove to be embarrassing, uncomfortable or worse to them.  When those people are rich and locally influential, the likelihood of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a> swallowing discussion increases.<br /><br />More specifically, we should be extremely skeptical of attempts at health care reform that add more bureaucracy to try to counter the effects of existing bureaucracy.  The main way current health care reform legislation seemed to address  the high costs and poor quality that we on Health Care Renewal contend may be due to concentration and abuse of power in health care is to further concentrate power without providing safeguards to prevent abuse.<br /><br />Finally, while this case was about whether hospitals (and other large organizations) hiring physicians to provide medical care may command higher prices, the real concern is whether physicians who now have to answer to corporate executives and organizational bureaucrats, that is who have become <a href="http://hcrenewal.blogspot.com/search/label/corporate%20physician">corporate physicians</a>,  may have to put their organizations' and their leaders' needs and wants ahead of their patients' and the public's health.<br /><br />True health care reform would be informed by the core value that physicians are supposed to endorse: the individual patient comes first.  Health care should not be mainly about increasing corporate revenues, or pleasing corporate executives or government bureaucrats.  However, big organizations and the in-group who personally profit from their operations want to keep such concerns anechoic.<br /><br />Instead, we all should start by appreciating the words of Judge Winmill and the information he has provided us. <br /><br />Roy M. Poses MD on Health Care Renewal

Who Knew? ... Judge Finds that Hospital Takeover of Medical Practices Raised Prices

A story that caused only a few ripples in the media in late January, 2014, corroborates concerns about the increasing concentration of power...

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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. <br /><br /><b>Background</b><br /><br />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:<br />-  The case became public with an apparently routine legal settlement between CareFusion and the US Department of Justice<br /> -  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<br />-  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<br />-  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<br />-  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<br />-  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<br />-  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.<br />- 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<br /><br /><b>Dr Denham's Previous Associates Now Have Doubts</b><br /><br />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:<br /><br /><br /><blockquote class="tr_bq"><i>Denham was appointed to Leapfrog's Safe Practices Committee as Chairman in 2006</i>. 'The position represented a voluntary commitment with no financial or contractual relationship between Dr. Denham and Leapfrog,' says a Leapfrog statement.<br /><br /> 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.<br /><br /> 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.'<br /><br /> Leapfrog has asked Denham and his company, TMIT, to '<i>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.'</i><br /><br />On Thursday, Binder issued a statement saying her board 'was concerned with <i>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</i> inconsistent with our organization's core values and mission.'<br /></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.  <br /><br />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  <br /><br /><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><br />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.<br /><br /><blockquote class="tr_bq"> A colleague visited him at his home in Laguna Niguel, an affluent beachfront LA suburb, and reported that it was <i>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>. </i>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, '<i>We’re in more than half the hospitals in America.</i>' It wasn’t entirely clear what this meant; <i>having visited many hospitals over the years, I never heard of one that was using the services of TMIT</i>, the way you hear about hospitals that work with Premier or the Advisory Board or the Governance Institute. <i>Very little of this added up</i>,...</blockquote><br />Another concern in retrospect was how Dr Denham became editor of a journal on patient safety: <br /><br /><blockquote class="tr_bq">The <a href="http://journals.lww.com/journalpatientsafety/pages/default.aspx" target="_blank"><i>Journal of Patient Safety</i></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 <i>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> 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, <i>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.</i></blockquote><br />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,<br /><br /><blockquote class="tr_bq">Over the past few years, I received <i>at least five different calls from colleagues</i> 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, <i>'Is this guy for real?'</i>  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 <i>not</i> 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 <i>did</i> understand.'</blockquote><br /><br />Again, it appears that Dr Denham's deceptions may have been considerably larger than indicated by the initial reports. <br /><br /><b>Senator Grassley Now Has Questions</b><br /><br />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,  <br /><br /><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.<br /><br /> 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><br />The NQF is in this hot seat because it gets extensive US government support,<br /><br /><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><br />The group promised a swift reply,<br /><br /><br /><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. <br /> <br />'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><br /><b>More Questions about How Dr Denham May Have Tried to Influence the NQF to Promote ChloraPrep</b><br /><br />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,<br /><br /><blockquote class="tr_bq"><i>The NQF committee's discussion of the study took place in </i><a href="http://www.modernhealthcare.com/assets/pdf/CH9291524.PDF"><i>August 2009</i> (PDF)</a>, and the results of the clinical trial comparing alcohol-chlorhexidine versus traditional iodine-based surgical antiseptics <i>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>.</i> Journals typically prohibit release of data in peer-reviewed studies before publication.</blockquote><br />The article also underscored a question raised by Senator Grassley<br /><br /><blockquote class="tr_bq">Grassley contends that <i>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.</i><br /><br />'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><br />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.  <br /><br /><b>Summary - Where are the Echoes?</b><br /><br /><br />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.<br /><br />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. <br /><br />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,<br /><br /><br /><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.<br /><br /> 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"><br /></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.  Backg...

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The Greedy Leading the Greedy - Multimillionaire Former Johnson and Johnson CEO Approved Huge Compensation for JP Morgan Chase CEO After Company Paid $20 Billion in Legal Settlements

<b>JP Morgan Chase CEO Got Huge Raise Despite Company's Recent Huge Legal Settlements </b><br /><br />The current compensation set by the board of directors of JP Morgan Chase for CEO Jamie Dimon, $20 million a year, has attracted some attention (e.g., see <a href="http://www.rollingstone.com/politics/blogs/taibblog/jamie-dimons-raise-proves-u-s-regulatory-strategy-is-a-joke-20140130">this commentary</a> by Matt Taibbi), especially given the contrast between his raise and the $20 billion or so the company had to pay out last year in settlements of allegations of unethical practices.  A New York Times <a href="http://www.nytimes.com/2014/02/01/business/accounting-for-jamie-dimons-big-pay-raise.html">opinion piece</a> rushed to Mr Dimon's defense<br /><br /><blockquote class="tr_bq">in the world of executive compensation, especially when viewed from the rarefied perspective of other chief executives, and more broadly on Wall Street, Mr. Dimon’s pay — and how it was determined — is <i>not only defensible, but laudable.</i></blockquote><br /><br />Also,<br /><br /><blockquote class="tr_bq">I spoke this week to several people with direct knowledge of the board’s discussions about Mr. Dimon’s pay. They said that the <i>compensation committee went through an exhaustive process </i>to determine the right level and that the board considered the likely negative reaction. 'We were mindful of it, but it didn’t influence our decision,' said one, who like the others, spoke only on condition of anonymity. 'Some people were going to criticize us unless we paid him nothing. <i>We were trying to do the right thing</i>.' </blockquote><br />The author did conclude with a quote from Rep Peter Welch (D - Vermont),<br /><br /><blockquote class="tr_bq">This isn’t really about Jamie Dimon. It’s about <i>a whole culture of immunity</i> for the consequences of your actions.<br /></blockquote><b>A Retired Pharmaceutical CEO Who Also was Hugely Compensated Despite his Company's Troubles Set Dimon's Pay </b><br /><br />We have frequently discussed how the culture of immunity, or <a href="http://hcrenewal.blogspot.com/search/label/impunity">impunity</a> found in <a href="http://hcrenewal.blogspot.com/search/label/finance">finance</a> may carry over into health care, since now many extremely rich  leaders of finance firms sit on boards of trustees of health care institutions like hospitals and hospital systems, universities and their associated medical schools and teaching hospitals, and health related foundations, and boards of trustees of health care corporations. <br /><br />In this case, maybe the culture carried over from health care to finance.<br /><br />The NY Times article noted<br /><br /><blockquote class="tr_bq"> The compensation and management development committee of JPMorgan Chase’s board has three members, <i>all seasoned business luminaries in their own right</i>. Lee R. Raymond, the chairman, is the former long-serving chairman and chief executive of Exxon Mobil. Stephen B. Burke is chief executive of NBCUniversal. <i>William C. Weldon is the former chairman and chief executive of Johnson & Johnson.</i></blockquote><br />Mr Weldon is the former pharmaceutical representative who rose to CEO of giant pharmaceutical/ biotechnology/ device company Johnson and Johnson.  Despite the appellation of business luminary above bestowed by the author of the NYT article, we noted <a href="http://hcrenewal.blogspot.com/2013/12/the-camels-aching-back-johnson-and.html">here</a> how many settlements have been made by, fines assessed against, and other adverse legal actions affecting Johnson and Johnson in the recent past.  Our lengthy summary of such cases is appended at the end of this post.<br /><br />Yet Mr William Weldon, the outgoing CEO on whose watch most of the misbehavior resulting in the legal actions listed in the appendix below occurred, retired with a huge retirement package, after receiving extremely generous compensation prior to that.   The retirement package was estimated to be worth from $143 to $197 million (look <a href="http://hcrenewal.blogspot.com/2012/03/despite-recalls-legal-settlements-and.html">here</a>).  In 2010, his total compensation was $29 million (look <a href="http://hcrenewal.blogspot.com/2012/02/semi-retirement-of-salesman-weldon-to.html">here</a>).   According to the <a href="http://www.investor.jnj.com/secfiling.cfm?filingID=1193125-12-113826">2012 Johnson and Johnson proxy statement</a>, his 2011 total compensation was greater than $26 million. As far as I can tell, Mr Weldon never suffered any negative consequences for his company's sorry record, and retired a very rich man.<br /><br />Yet the luminous Mr Weldon got to make the decision about how much to pay Mr Jamie Dimond after his company's recent sorry record.<br /><br /><b>Summary</b><br /><br />So it appears that the top hired executives of health care and finance organizations, and the so-called stewards sitting on their boards of directors are all blending together.  Together they are in charge of assuring that top hired executives get richer and richer even while the companies they lead commit seemingly endless strings of ethical and sometimes legal offenses.<br /><br /><br />Is this any way to run health care, or the economy?<br /><br />As I have repeated ad nauseum,<br /><br /><div class="A_Standard__35__20_Normal">Many of largest and once proud health care organizations now have recent records of repeated, egregious ethical lapses. Not only have their leaders have nearly all avoided penalties, but they have become extremely rich while their companies have so misbehaved. <br /><br />These leaders seem to have become like nobility, able to extract money from lesser folk, while remaining entirely unaccountable for bad results of their reigns. We can see from this case that health care organizations' leadership's nobility overlaps with the supposed "royalty" of the leaders of big financial firms, none of whom have gone to jail after the global financial collapse, great recession, and ongoing international financial disaster (look <a href="http://hcrenewal.blogspot.com/2012/08/duchess-of-wellpoint-abdicates-likely.html">here</a>). The current fashion of punishing behavior within health care organization with fines and agreements to behave better in the future appears to be more law enforcement theatre than serious deterrent.  As Massachusetts Governor Deval Patrick exhorted his fellow Democrats, I exhort state, federal (and international, for that  matter) law enforcement to "<a href="http://www.washingtonpost.com/blogs/election-2012/wp/2012/09/04/patrick-it-is-time-for-democrats-to-grow-a-backbone/">grow a backbone</a>" and go after the people who were responsible for and most profited from the ongoing ethical debacle in health care.<br /><br />Again, true health care reform would make leaders of health care organization accountable for their organizations' bad behavior.</div><br /><br /><div class="A_Standard__35__20_Normal"><b>Appendix - Johnson and Johnson Recent Legal Record</b></div><div class="A_Standard__35__20_Normal"></div><div class="A_Standard__35__20_Normal"></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;"><u>2010 </u></span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">- Convictions in two different states in 2010 for misleading marketing of Risperdal</span><br /><span style="background-color: #eeeeee;">- A guilty plea for misbranding Topamax in 2010</span><br /><span style="background-color: #eeeeee;"><u>2011</u></span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">- Guilty pleas to bribery in Europe in 2011 by Johnson and Johnson's DePuy subsidiary</span><br /><span style="background-color: #eeeeee;">- A guilty plea for marketing Risperdal for unapproved uses in 2011 (see <a href="http://hcrenewal.blogspot.com/2011/08/why-cultivate-weldons-confidence-ceo.html">this link</a> for all of the above)</span><br /><span style="background-color: #eeeeee;">- A guilty plea to misbranding Natrecor by J+J subsidiary Scios (see post <a href="http://hcrenewal.blogspot.com/2011/09/johnson-and-johnson-pleads-guilty.html">here</a>)</span><br /><span style="background-color: #eeeeee;"><u>2012 </u></span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">- In 2012, testimony in a trial of allegations of unethical marketing of the drug Risperdal (risperidone) by the Janssen subsidiary revealed a systemic, deceptive stealth marketing campaign that fostered suppression of research whose results were unfavorable to the company, ghostwriting, the use of key opinion leaders as marketers in the guise of academics and professionals, and intimidation of whistleblowers. After these revelations, the company abruptly settled the case (see post <a href="http://hcrenewal.blogspot.com/2012/02/texas-tmap-trials-as-illustration-of.html">here</a>).</span><br /><span style="background-color: #eeeeee;">-  Also in 2012,  Johnson & Johnson was fined $1.1 billion by a judge in Arkansas for deceiving patients and physicians again about Risperdal (look <a href="http://hcrenewal.blogspot.com/2012/04/once-more-with-feeling-johnson-and.html">here</a>).</span><br /><span style="background-color: #eeeeee;">-  Also in 2012, Johnson & Johnson announced it would pay $181 million to resolve claims of deceptive advertising again about Risperdal (see this <a href="http://hcrenewal.blogspot.com/2012/09/how-many-legal-settlements-does-it-take.html">post</a>). </span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;"><u>2013</u></span> </div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">-  In 2013, Johnson & Johnson settled case by shareholders alleging that management made misleading statements and withheld material information about manufacturing problems (see this <a href="http://hcrenewal.blogspot.com/2013/07/johnson-and-johnson-settles-suit.html">post</a>)</span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">-  In 2013, Johnson & Johnson Janssen subsidiary pleaded guilty to a charge of misbranding Risperdal, and settled for a total of $2.2 billion allegations that it promoted the drug for elderly demented patients and adolescents without an indication, and despite evidence of its harms (see this <a href="http://hcrenewal.blogspot.com/2013/11/another-and-huge-22-billion-settlement.html">post</a>).  </span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">-  In 2013, Johnson & Johnson DePuy subsidiary agreed to settle with multiple plaintiffs for $2.5 billion allegations that it sold defective mental-on-metal artificial hip, and hid evidence of its harms .</span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">- In 2013, Johnson & Johnsonn Janssen subsidiary was found by two juries to have concealed harms of its drug Topamax (see this <a href="http://hcrenewal.blogspot.com/2013/11/there-they-go-again-again-johnson-and.html">post</a> for this and above case).</span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">- In 2013, Johnson & Johnson Ethicon subsidiary's Advanced Surgical Products and two of its executives agreed to settle charges by US FDA that is sold mislabeled products used to sterilize equipment such as endoscopes (see this <a href="http://hcrenewal.blogspot.com/2013/12/how-many-straws-johnson-and-johnson.html">post</a>). </span></div><div class="A_Standard__35__20_Normal"><span style="background-color: #eeeeee;">- In 2013, Johnson & Johnson fined by European Commission for anticompetitive practices, that is, collusion with Novartis to delay marketing generic version of Fentanyl (see this <a href="http://hcrenewal.blogspot.com/2013/12/the-camels-aching-back-johnson-and.html">post</a>).  </span></div>

The Greedy Leading the Greedy - Multimillionaire Former Johnson and Johnson CEO Approved Huge Compensation for JP Morgan Chase CEO After Company Paid $20 Billion in Legal Settlements

JP Morgan Chase CEO Got Huge Raise Despite Company's Recent Huge Legal Settlements The current compensation set by the board of director...

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Putting Finance Executives in Charge of Health Care? - What Could Possibly Go Wrong?

A US News and World Report <a href="http://health.usnews.com/health-news/hospital-of-tomorrow/articles/2014/01/28/wanted-hospital-ceos-without-health-care-experience">article</a> affirms what we have <a href="http://hcrenewal.blogspot.com/2013/12/health-care-experience-hospital-ceos.html">previously written</a>, that those charged with the stewardship of US hospitals are even more inclined now to hire top managers with little or no health care experience or credentials. <br /><br /><b>Putting Finance Managers in Charge </b><br /><br />They particularly seem to favor executives drawn from the world of finance.<br /><br />Just to make it really clear, the exposition started with the article title, <br /><br /><blockquote class="tr_bq">Wanted: Hospital CEOs Without Health Care Experience </blockquote><br />The article drew on some of the figures about executive hiring which we <a href="http://hcrenewal.blogspot.com/2013/12/health-care-experience-hospital-ceos.html">discussed</a> in December, 2013,<br /><br /><blockquote class="tr_bq">It’s expected that<i> two-thirds of hospital CEOs hired this year will have little to no health care experience,</i> according to Black Book Rankings, which last year conducted a poll of 1,404 human resource officers and board members of health care organizations</blockquote><br />However, the new article profiled some examples,<br /><br /><blockquote class="tr_bq">.When Carlos Migoya was hired in May 2011 to run Jackson Health System, Miami-Dade County’s safety net hospital system, he had no health care experience. <i>A career banker</i>, Migoya took over.....</blockquote><br />Also,<br /><br /><blockquote class="tr_bq">Mike Keating, CEO of Christ Hospital in Cincinnati, previously was <i>an investment banker</i>.;Robert Meyer, president and CEO of Phoenix Children's Hospital, came from the <i>consulting world;</i>... </blockquote><br /><br />The article stressed that hospital boards think a background in finance is particularly valuable.<br /><br /><blockquote class="tr_bq">Hospital board and HR directors are looking for <i>non-industry productivity, business development and <b>financial management </b>experts with heavy technological expertise. </i></blockquote><br />Also,<br /><br /><blockquote class="tr_bq">[executive vice president and managing principle at Cejka Executive Search. Paul]  Esselman  notes that boards increasingly 'are looking at leaders from managed care, the payer side or from f<i>inance or banking</i>.'</blockquote><br /><b>Why Hospital Boards Favor Finance Executives </b><br /><br /><blockquote class="tr_bq">banking, like health care, is heavily regulated and that two decades ago banking went through significant consolidation, which hospitals today face.</blockquote><br />So,<br /><br /><blockquote class="tr_bq">[ managing partner of Black Book Rankings Doug] Brown says leaders that come from productivity-focused fields and sectors that have endured consolidation are particularly suited for running hospitals today. <i>Those in financial services may prove useful in today’s climate,</i> as 'there are a lot of troubled hospitals,' he says.</blockquote><br />As we <a href="http://hcrenewal.blogspot.com/2013/12/health-care-experience-hospital-ceos.html">noted before</a>, the article suggested that those who hire hospital executives think their most important challenges s included  -<br /><br /><blockquote class="tr_bq">'<i>Communication</i> is now more important than ever,; says Paul Esselman</blockquote><br /><blockquote class="tr_bq">the opportunities come in <i>delivering its service or business lines to ever-expanding distribution channels</i>.</blockquote><br /><blockquote class="tr_bq">says [former investment banker Mike] Keating. 'The key in health care is how you go about <i>executing</i> and executing well.'</blockquote><br /><blockquote class="tr_bq">[former banker Carlos] Migoya put in place <i>operational reforms</i>, including bringing in 'a lot of people with for-profit experience' to <i>maintain expense controls, monitor operations, collect payments more quickly and pay its own bills sooner</i> to gain prompt-payment discounts. Then, 'we <i>realigned procurement</i>,' he says, adding 'we motivate our procurement department with incentives,' which 'dramatically improved' Jackson Health’s process, time and costs. Meanwhile, the system <i>outsourced pharmaceutical management</i>, saving $15 million a year.... </blockquote><br />Note that these examples are all about management process and financial outcomes, NOT about clinical processes, quality of care, or patient outcomes.  (The only mention of anything close to clinical management was a plan to outsource same.)<br /><br />Left unsaid is that the boards charged with the stewardship of hospitals are now mainly composed of business executives, often heavily weighted with those in finance. <br /><br /><b>Summary - What Could Go Wrong?</b><br /><br />Of course, former bankers, and others from the world of <a href="http://hcrenewal.blogspot.com/search/label/finance">finance </a>may not really know much about clinical work, quality of care, or patient outcomes.  They may not have been picked because they care about such issues, nor socialized with the "patient first" mantra which health professionals are supposed to support. <br /><br />Worse, it seems that those who choose hospital executives may not be thinking about the recent history of finance.  True, it shares with health care the presence of regulation and increasing consolidation.  However, as we all started to realize in 2008, the leaders of finance helped bring on the worst financial crisis since the great depression.  More than five years since the beginning of this new great recession, US median income is dropping adjusted for inflation, while income inequality has tremendously increased.  Finance executives have been prime proponents of <a href="http://hcrenewal.blogspot.com/search/label/financialization">financialization</a>, the theory that increasing shareholder value, which really seems to translate into increasing organizational short term income and increasing executive compensation are more important than any other outcomes.  Thus seems to correspond to the discussion above about financial and management objectives sans any notion of what is good for patients.<br /><br />Even more disturbing is all the anecdotal evidence that business management, particularly in finance, has been gripped by overarching greed.  Pope Francis called it the "idolatry of money."  (look <a href="http://www.washingtonpost.com/business/economy/pope-francis-denounces-trickle-down-economic-theories-in-critique-of-inequality/2013/11/26/e17ffe4e-56b6-11e3-8304-caf30787c0a9_story.html">here</a>).<br /><br />In his graphic <a href="http://www.nytimes.com/2014/01/19/opinion/sunday/for-the-love-of-money.html">memoir</a> of his days as a successful Wall Street trader, Sam Polk called it wealth addiction, .  <br /><br /><blockquote class="tr_bq">I noticed the vitriol that traders directed at the government for limiting bonuses after the crash. I heard the fury in their voices at the mention of higher taxes. These traders despised anything or anyone that threatened their bonuses. Ever see what a drug addict is like when he’s used up his junk? He’ll do anything — walk 20 miles in the snow, rob a grandma — to get a fix. Wall Street was like that. In the months before bonuses were handed out, the trading floor started to feel like a neighborhood in 'The Wire' when the heroin runs out.</blockquote><br />He was not the first to describe wealth addiction:<br /><br /><blockquote class="tr_bq"> Wealth addiction was described by the late sociologist and playwright Philip Slater in a 1980 book, but addiction researchers have paid the concept little attention. Like alcoholics driving drunk, wealth addiction imperils everyone. Wealth addicts are, more than anybody, specifically responsible for the ever widening rift that is tearing apart our once great country. Wealth addicts are responsible for the vast and toxic disparity between the rich and the poor and the annihilation of the middle class. Only a wealth addict would feel justified in receiving $14 million in compensation — including an $8.5 million bonus — as the McDonald’s C.E.O., Don Thompson, did in 2012, while his company then published a brochure for its work force on how to survive on their low wages. Only a wealth addict would earn hundreds of millions as a hedge-fund manager, and then lobby to maintain a tax loophole that gave him a lower tax rate than his secretary.</blockquote><br />Physicians swear oaths to put patient care ahead of all else.  While we may be far from perfect in our adherence to these oaths, I would like to think that when health care organizations were lead by health professionals, many tried to put patient care first  Yet professional managers, not health care professionals now lead health care.<br /><br />.In 1988, Alain Enthoven advocated in <a href="http://www.amazon.com/gp/product/0444703594/102-6581115-0444916?n=283155">Theory and Practice of Managed Competition in Health Care Finance</a>, a book published in the Netherlands, that to decrease health care costs it would be necessary to break up the "physicians' guild" and replace leadership by clinicians with leadership by managers (see 2006 post <a href="http://hcrenewal.blogspot.com/2006/03/consequences-of-breaking-physicians.html">here</a>). Thus from 1983 to 2000, the number of managers working in the US health care system grew 726%, while the number of physicians grew 39%, so the manager/physician ratio went from roughly one to six to one to one (see 2005 post <a href="http://hcrenewal.blogspot.com/2005/04/growing-proliferation-of-managers.html">here</a>). As we noted <a href="http://hcrenewal.blogspot.com/2013/09/a-plague-of-bureaucrats-now-10-per.html">here</a>, the growth continued, so there are now 10 managers for every US physician.<br /><br />The managers who first took over health care may have had some health care background.  Now it seems that health care managers are decreasingly likely to have any health care background, and increasingly likely to be from the world of finance.  Can anyone seriously believe that finance managers taught to put short-term revenue first, and who may often be wealth addicts who practice the idolatry of money in charge of health care is going to improve anything other than those same managers' wealth?<br /><br />As I have said before,  true health care reform would put in place leadership that understands the health care context, upholds health care professionals' values, and puts patients' and the public's health ahead of extraneous, particularly short-term financial concerns. We need health care governance that holds health care leaders accountable, and ensures their transparency, integrity and honesty.<br /><br />But this sort of reform would challenge the interests of managers who are getting very rich off the current system.  So I am afraid the US may end up going far down this final common pathway before enough people manifest enough strength to make real changes.

Putting Finance Executives in Charge of Health Care? - What Could Possibly Go Wrong?

A US News and World Report article affirms what we have previously written , that those charged with the stewardship of US hospitals are ev...

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