DOES AMERICAN PSYCHIATRY MATTER?

<br />DOES AMERICAN PSYCHIATRY MATTER?<br /><br />The blogmeister of 1boringoldman.com has done it again. A semi-retired psychiatrist in rural Georgia, he has done more than anyone to document the follies and the ethical challenges of contemporary American psychiatry. His site is required reading for all who care about behavioral health issues. <br /><br />In his <a href="http://1boringoldman.com/index.php/2012/11/02/cest-la-vie/">latest posting</a> he compared the domain of American psychiatry to Yugoslavia. Cast Melvin Sabshin as Marshal Tito. Sabshin was the medical director of the American Psychiatric Association in the late 1970s, the period leading up to DSM-III. Tito and Sabshin each strong-armed a confederation of sorts but failed to deal with the conflicts beneath the surface. Both leaders were faced with the prospect of their domains disintegrating – Tito’s at the hands of Moscow and Sabshin’s at the hands of insurance companies. Both persuaded wary stakeholders to sign on to a compromise, for want of anything better and fearing a worse outcome.<br /><br />The domain of psychiatry hasn’t yet reached the stage of ethnic cleansing and genocide that we saw in Yugoslavia after Tito’s death, but it is well on the way. One only has to look at the vicious response of the American Psychiatric Association leaders to Allen Frances and other critics of DSM-5. The APA president in 2009, Alan Schatzberg from Stanford, went out of his way to <a href="http://www.psychi%20imes.com/dsm-5/content/article/10168/1425806atrict">smear</a> Dr. Frances and Robert Spitzer, the architects of DSM-IV and DSM-III because he had no credible scientific response to their criticisms of the directions DSM-5 is taking. He was joined in this low act by David Kupfer and Darrel Regier, who are directing the DSM-5 effort. Where is the comity, Comrades? Where are the shared values? Why is the APA holed up in a bunker?<br /><br />Then we have the unsavory sight of the APA lawyers <a href="http://hcrenewal.blogspot.com/2012/01/self-inflicted-damage.html">threatening</a> a blogfrauchen in the U.K. with a SLAPP lawsuit for alleged infringement on the APA’s intellectual property – as though the APA owns psychiatric classification! Talk about chutzpah. So now the confederation Sabshin cobbled together is breaking up and the stakeholders are starting to go their separate ways – psychologists, counselors, social workers, patient advocacy groups, even many psychiatrists. Christopher Lane in <a href="http://www.psychologytoday.com/blog/side-effects/200912/american-psychiatry-is-facing-civil-war-over-its-diagnostic-manual">Psychology Today</a> has said American psychiatry is facing “Civil War” over its diagnostic manual. Even an international psychiatric journal like British Journal of Psychiatry is <a href="http://bjp.rcpsych.org/content/201/4/334.full">distancing itself</a> from DSM-5 and there is talk of abandoning DSM-5 for the next ICD classification.<br /><br />Why is American psychiatry self destructing? Because the grand bargain forged in 1980 with DSM-III was a sham from the get-go and the promised benefits of diagnostic reliability have not materialized. They knew all along that reliability was a poor substitute for validity, but they settled for half a loaf. That compromise led us into the <a href="http://hcrenewal.blogspot.com/2009/04/in-defense-of-psychiatric-diagnoses-and.html">epistemologic quagmire</a> of today, where there is no solid ground for clinical decisions or clinical research progress or drug development. A stunning absence from the DSMs to date is any statement about treatment. That compromise also led us to diagnostic inflation, which Pharma embraced. Pharma quickly filled the vacuum with <a href="http://www.ncbi.nlm.nih.gov/pubmed/15169734">experimercials</a> that <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">pretended</a> to be real clinical science, and in the process diverted precious clinical research infrastructure away from genuinely important questions. Just look at the clinical trials er, experimercials, mill operating out of Massachusetts General Hospital at Harvard University.<br /><br />What lies ahead? Stakeholders are going to vote with their feet. DSM-5 is likely to be a footnote in the history of psychiatric classification. The APA will become even less relevant than it is today, much like the American Medical Association, which now commands the loyalty of maybe <a href="http://mediamatters.org/research/2009/06/15/nbcs-guthrie-falsely-suggests-ama-represents-th/151182">30% of U.S. physicians</a>. Mel Sabshin will turn in his grave, the APA will lose revenue, ICD-11 will become the dominant classification of psychiatric disorders, and the quagmire will continue until a new synthesis arises from the ashes. If Yugoslavia is any kind of model, don’t hold your breath.<br /><br />

DOES AMERICAN PSYCHIATRY MATTER?

DOES AMERICAN PSYCHIATRY MATTER? The blogmeister of 1boringoldman.com has done it again. A semi-retired psychiatrist in rural Georgia, he ha...

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Just Another Day at the Office: Boehringer Ingelheim Settles Allegations of Deceptive Off-Label Marketing, Kickbacks

Legal settlements by pharmaceutical companies for less than $100 million now seem to barely rate as news in the US. The best report, albeit short, of a by Boehringer Ingelheim for a mere $95 million, seems to be<a href="http://articles.courant.com/2012-10-26/business/hc-boehringer-ingelheim-fraud-20121026_1_hypertension-drug-civil-settlement-risk-of-heart-attacks"> in the Hartford (CT) Courant</a>. The summary was: <br /><blockquote>Boehringer Ingelheim, a German company with U.S. headquarters in Ridgefield, has agreed to pay $95 million to settle allegations that it promoted four drugs for uses unsupported by research, and that it paid kickbacks to doctors to prescribe the drugs, the U.S. Department of Justice has announced. </blockquote>It included most of the usual elements.<br /><br /><b>Off Label Marketing</b><u> </u><br /><blockquote>Two of the drugs in the case are for treating chronic bronchitis and emphysema, and were suggested for children with asthma and coughs from the flu. The drugs had not been tested on children. </blockquote><blockquote>'I was concerned that <i>doctors were basing their treatment decisions on false information</i>,' [former Boehringer Ingelheim pharmaceutical representative and whistle blower Ron] Heiden said in the released statement. '<i>Promoting off-label treatments with potential serious consequences just to increase sales is heinous behavior</i>.' </blockquote>I note parenthetically that some industry apologists belittle the possible harms of truthful off-label marketing (e.g., look <a href="http://hcrenewal.blogspot.com/2008/08/what-influences-advocates-of-providing.html">here</a>).  However, at least in this case, the marketing was alleged to be based on falsehoods. <br /><br />Furthermore, some industry apologists may also decry the regulation of off-label marketing as a violation of the US Constitutional guarantees of freedom from government infringement on individual free speech<a href="http://hcrenewal.blogspot.com/2008/08/what-influences-advocates-of-providing.html"></a>.  Note, however, that Boehringer Ingelheim in this case got exclusive rights to market these drugs for many years from the government.  In exchange for these rights, the law restricted their right to market the drugs to approved indications.   <br /><br /><b>Promotion Beyond the Evidence </b><br /><blockquote>The company told doctors Aggrenox was better than Plavis to reduce the risk of heart attacks, but there was no evidence to support that claim, the Justice Department said. The drug had FDA approval to prevent secondary strokes. </blockquote>Again, the truthfulness of the premises underlying the marketing apparently was questionable, to use charitable phrasing.   <br /><br /><b>Kickbacks to Physicians</b><br /><br />This information came from the AP version of the story, here <a href="http://www.washingtonpost.com/business/pharmaceutical-company-to-pay-95m-to-settle-allegations-of-improper-promotion/2012/10/25/ef595032-1ee1-11e2-8817-41b9a7aaabc7_story.html">via the Washington Post</a>: <br /><blockquote>the settlement resolved allegations that Boehringer Ingelheim paid kickbacks to health care professionals to induce them to prescribe all four of the drugs. These <i>kickbacks included payments for participating in advisory boards, speakers’ training programs, speaker programs and consultant programs. </i></blockquote> Note further that apologists for industry also belittle the importance of the effects of conflicts of interest on health care (e.g., look <a href="http://hcrenewal.blogspot.com/2009/07/stossel-and-acre-wheres-beef.html">here</a>).  In this case, activities that are often referred to as species of conflicts of interest, e.g., advisory board membership, speakers board membership, consulting, apparently were meant as vehicles for payments to induce prescribing.  That is, apparently what some might have called conflicts of interests were allegedly kickbacks, or bribes.  As we have discussed before, it is one thing to be paid for legitimate clinical, educational, or scientific activity when such payments might influence professional, educational, or scientific judgments or activities about other matters.  It is entirely another thing to be paid a kickback to favor a drug company's marketing campaign instead of making decisions that put patients first.<br /><br /><b>A Corporate Integrity Agreement</b><br /><br />[From the Hartford Courant] <br /><br /><blockquote class="tr_bq">Also as part of the settlement, Boehringer agreed to enter into an expansive Corporate Integrity Agreement to avoid such marketing in the future.</blockquote><br /> We have noted before that such agreements do not seem to deter future bad behavior, (e.g., look <a href="http://hcrenewal.blogspot.com/search/label/corporate%20integrity%20agreement">here</a>).<br /><br /><b>No Admission of Wrongdoing by the Company</b><br /><br />[from the AP]<br /><br /><blockquote class="tr_bq">'The pharmaceutical industry as a whole has undergone significant changes over the past decade and continues to be under intense scrutiny,' said Greg Behar, president and chief executive officer of Boehringer Ingelheim. 'Likewise, our internal processes and compliance practices have evolved significantly over the years.' The company said it has been cooperating with the government investigation.</blockquote>Again, if there is no acknowledgement by the company that it did wrong, do we expect it not to do wrong in the future?<br /><br /><b>Summary</b><br /><br />Here was yet another legal settlement that documents the pervasiveness of the influence of marketing and public relations over physicians' professional responsibilities.  This is just one of several recent posts (e.g., <a href="http://hcrenewal.blogspot.com/2012/10/marketers-systemic-influence-over.html">here</a> and <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">here</a>) about the malevolent influence of <a href="http://hcrenewal.blogspot.com/search/label/deception">deceptive</a> marketing or public relations on the evidence that health care professionals should be using to make the best possible decisions for individual patients.<br /><br />Such <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">legal settlements</a> seemingly have had no effect on the bad behavior of big health care organizations, while they continually erode trust in these organizations and their leadership, and trust in physicians to put patients ahead of personal gain. <br /><br />Furthermore, these cases seem to be part of a larger social problem.  It seems that nowadays the leadership of large, powerful organizations feels free to promote their own interests using psychologically sophisticated but deceptive marketing and public relations strategies no matter what their effect on the public welfare. <br /><br />As we have said all too many times before, we will not deter unethical behavior by health care organizations until the people who authorize, direct or implement bad behavior fear some meaningfully negative consequences. Real health care reform needs to make health care leaders accountable, and especially accountable for the bad behavior that helped make them rich.<br /><br /><br />

Just Another Day at the Office: Boehringer Ingelheim Settles Allegations of Deceptive Off-Label Marketing, Kickbacks

Legal settlements by pharmaceutical companies for less than $100 million now seem to barely rate as news in the US. The best report, albeit...

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Marketers' Systemic Influence over Ostensibly Scholarly, Peer-Reviewed Publications: the Medtronic Infuse BMP-2 Example

On the heels of our <a href="http://hcrenewal.blogspot.com/2012/10/when-clinical-trials-are-meant-for.html">discussion</a> of how one pharmaceutical company employed a "publications strategy" to commission and control randomized controlled trials to serve marketing purposes, a US Senate committee has released a report about how a device/ biotechnology company "influenced the content of articles in peer-reviewed scientific publications to present... [its product] in the best possible light."<br /><br />The report was <a href="http://online.wsj.com/article/SB10001424052970204530504578076993827301944.html">summarized</a> by the Wall Street Journal, <br /><br /><blockquote class="tr_bq">A report by the Senate Finance Committee based on thousands of documents it subpoenaed from Medtronic Inc<i> raises new questions about the integrity of the medical research underpinning one of the medical-device maker's products</i>.<br /><br /><i>Medtronic was 'heavily involved in drafting, editing and shaping the content of medical journal articles' about the product</i>—a bone-growth protein used in spine surgery called Infuse—<i>even as it was paying the physicians who wrote those articles a total of $210 million for unrelated work</i>, the Senate report alleges.<br /><br />In one instance, <i>a Medtronic employee recommended to one of the physicians not publishing a list of side effects</i> associated with Infuse in a 2005 journal article, company emails show. <i>Medtronic marketing officials also urged inserting language into other journal articles touting the use of Infuse as better for patients</i> than using bone harvested from their pelvises because of the pain associated with the latter, other company documents show.<br /><br /><i>Medtronic's influence extended to preparing a physician's 2002 speech to a panel advising the Food and Drug Administration </i>on whether to approve the drug, the report alleges. The physician's disclosure to the panel at the time suggested his testimony was independent, but the company had in fact helped him draft it and paid him as a consultant the previous year, company documents show. Medtronic later hired the physician as an executive.<br /><br />In response to the Senate report, Medtronic issued a statement saying it 'vigorously' disagreed with any suggestion that 'it improperly influenced or authored any of the peer-reviewed published manuscripts.' The company also denied that it 'intended to under-report adverse events' associated with Infuse.</blockquote><b>The Extent of the Problem </b><br /><br />The report itself is available <a href="http://www.finance.senate.gov/imo/media/doc/Medtronic_Report1.pdf">here</a>. It is worth discussing some of its sections about how the company is alleged to have influenced the peer-reviewed, scholarly clinical literature in more detail.<br /><br />First, it asserted that "Medtronic employees, including employees working for its marketing department, collaborated with physician authors, many of whom had significant financial relationships with Medtronic, to draft" 11 specific articles in the literature published between 2002 and 2009.<br /><br /><b>Obfuscating Adverse Effects</b><br /><br />The report provided detail about specific instances in which Medtronic employees appeared to influence publication to further marketing objectives.  The first was apparently to cloud discussion of adverse effects of its product [italics added for emphasis]:<br /><br /><blockquote class="tr_bq">documents indicate that a Medtronic employee involved in editing a draft of the 2005 Journal of Bone and Joint Surgery (JBJS) article by Burkus, et al. about a similar InFuse procedure involving allograft bone (a cage made from donated bone rather than the FDA-approved titanium), <i>recommended that 'significant detail' concerning adverse event  data should not be published.</i><br /><br />On June 16, 2004, Dr. Julie Bearcroft, <i>Director of Technology Management in Medtronic’s Biologics Marketing Department,</i> wrote an e-mail to other Medtronic employees, commenting on a draft of the study, 'I have made some significant changes to this document (some at the request of Dr. Burkus) both in format and content.  In this e-mail, she asked: 'How much information should we provide relative to adverse events? . . . You will see my [note] in the attached document but <i>I don’t think significant detail on this section is warranted</i>.'  The referenced note in the draft article stated: 'I don’t believe we want to report in the same manner as we do in IDE studies. I personally think <i>it is appropriate to simply report the adverse events were equivalent in the two groups without the detail.'</i> According to an internal e-mail, the adverse events were observed in the trial and formatted in a detailed table. But following the advice of Bearcroft, this table of adverse events was not included in the published paper.<br /><br />On July 3, 2004, after Medtronic edited the paper, Dr. Burkus sent a draft to his co-authors writing that 'this manuscript documents the superiority in clinical and radiographic outcomes with the use of rhBMP2 in a study population of only 133 patients.'<br /><br />According to the Carragee et al. Spine Journal article published in 2011, the 2005 JBJS article 'reported no complications, such as end-plate fracture, collapse, and implant migration associated with rhBMP–2 despite the clear radiographic findings in at least the one presented case.  The e-mail exchange indicates that,<i> in addition to Medtronic editing the manuscript without attribution, the company was recommending that the article omit a complete accounting of adverse event data, including serious adverse event data that were already considered a documented concern by FDA in similar application.</i><br />  <br />These types of adverse events were disclosed in Table V of a 2009 follow-up article concerning the original IDE study. Studies published in 2007 revealed that InFuse is associated with 'a clinically important early inflammatory and osteoclastic effect of the rhBMP–2 in soft tissue and bone, respectively.  In other words, Medtronic recommended against including information in the study that was ultimately revealed to have an association between In-Fuse and weakening that could lead to collapse of the bone and implant and required that patients undergo additional surgery.</blockquote><br />Note that in this example, someone explicitly associated with marketing apparently edited a draft of a scholarly article, suggested that detail about adverse effects of the company's product be omitted, and that the published article in fact omitted such detail. <br /><br />The report also included an example in which another Medtronic employee apparently tried to "tone down" the discussion of adverse effects of the product, but did so too late to influence the published version.  <br /><br /><b>Emphasizing the Adverse Effects of an Alternative to Using the Company's Product</b><br /><br />On the other hand, the report also included an example in which it alleged that a company employee suggested adding emphasis to the drawbacks of using a management strategy that did not include use of the company's product.<br /><br /><blockquote class="tr_bq">Documents show that <i>Medtronic edited draft publications to stress the pain patients experienced from undergoing a bone graft procedure instead of receiving InFuse</i>. Medtronic markets InFuse as a less painful alternative to bone graft procedures for patients undergoing spinal fusion surgery.</blockquote><br />In particular, <br /><br /><blockquote class="tr_bq">After receiving a draft of an early InFuse study 52 to review in October 2001, Medtronic’s Neil Beals, whose '<i>primary job responsibility was to manage Biologics marketing programs and initiatives,</i>'  <i>recommended that the physician authors of the study emphasize pain experienced by patients who received the bone graft</i>. The patients were divided into an investigative group that received InFuse and a control group that received a bone graft obtained from the iliac crest of their pelvis.  An October 31, 2001 e-mail shows that Beals suggested to Dr. Burkus that '<i>a bigger deal should be made of elimination of donor site pain with INFUSE . . . so that ‘equivalent’ results aren’t received as a let down</i>.'   Again, after reviewing a later draft of the study, Beals asked Dr. Burkus on March 8, 2002, '<i>would it be appropriate to make a bigger deal out of donor site pain</i> and include more discussion and references?  Subsequently, a sentence was inserted at the end of a later draft, and included in the published version of the article, that read, 'The use of rhBMP–2 is associated with high fusion rates without the need for harvesting bone graft from the iliac crest and <i>exposing the patient to the adverse effects associated with that procedure.</i>'<br /><br />Medtronic also sought to include discussion of long-term pain in the Baskin, et. al. 2003 paper on InFuse in the cervical spine. In a draft of the publication that was being circulated on August 30, 2002, the authors wrote, '[b]y 12 months after surgery, the patients [sic] graft-site pain had resolved . . . and no patients complained about the graft-site appearance.'  Beals inserted comments after this sentence stating, '<i>ALTHOUGH THE PATIENTS DID NOT COMPLAIN ABOUT APPEARANCE DIDN’T SOME STILL EXPERIENCE PAIN AT THE DONOR SITE? SEEMS LIKE RESIDUAL EFFECTS OF DONOR SITE SHOULD BE NOTED</i>.  [sic] [emphasis in original]. In an e-mail to his colleague, Beals wrote, '<i>I would also add in more discussion on donor site pain and need for osteogenetic graft material (plant seed of doubt for just using allograft by itself )</i>.  A review of the final published article reveals that, after Beals made the suggestion to emphasize pain at the bone graft site, a sentence was added in the final version of the article that read,  '. . . even at the 24-month follow-up assessment, <i>some patients continued to experience residual pain at the donor site, and rated the appearance of the site as only fair</i>.'</blockquote><br />Note that in these two examples, another marketing employee edited drafts of two scholarly articles, suggested that more emphasis be put on supposed adverse effects of the procedure that the articles compared to the procedure which used the company's product, and that the two articles included such emphasis.  <br /><br /><b>Deceptive Response to Peer Reviewers' Criticisms of Apparent Bias </b><br /><br />Finally, the report included an instance in which a company employee managed correspondence between an article's ostensible first author and journal editors to try to defend wording which reviewers had criticized for bias in favor of the company's product.<br /><br />In summary,<br /><br /><blockquote class="tr_bq">E-mail exchanges between Dr. Burkus and Medtronic employees regarding a study of InFuse utilizing the posterior lumbar interbody fusion (PLIF) technique and published in The Spine Journal in 2004 demonstrates that<i> Medtronic employees not only edited the draft manuscript to include comments supportive of InFuse,  they also covertly participated in the peer-review process by drafting responses to peer-reviewers on behalf of the physician authors</i> named on the paper.</blockquote><br />In particular, one employee, Rick Treharne, previously identified as "Senior Vice President of Clinical and Regulatory Affairs," wrote a very positive summary statement for the article's discussion section:<br /><br /><blockquote class="tr_bq">In a January 10, 2003, e-mail to Dr. Burkus, Rick Treharne wrote, 'In looking over the data,<i> I was impressed with how well the BMP patients actually did. So much so that I added a few paragraphs at the end</i> that you may not agree with.' </blockquote>However, the reviewers were skeptical,<br /><br /><blockquote class="tr_bq">One reviewer wrote: 'Unless the authors can discuss the results of this study in an unbiased manner, which they have been unable to do in its present form, this data should not be published.'  Another reviewer wrote: 'The manuscript is full of biased statements that are a reflection of the data evaluators—the company that markets the product.'  That reviewer recommended a discussion of potential bias in the text of the paper writing,  'As it stands it is an advertisement for a specific product without significant scientific merit.'</blockquote><br />Then, Medtronic employees then took over the process of responding to this review, to wit,<br /><br /><blockquote class="tr_bq">E-mail correspondence on May 28, 2003, indicates that <i>Medtronic’s Rick Treharne wrote and sent Dr. Burkus a draft letter to Dr. Tom Mayer, Editor-in-Chief of The Spine Journal</i>, to address concerns raised by orthopedic surgeons tasked with peer-reviewing the submitted PLIF paper. <i>A subsequent e-mail by Julie Bearcroft notes that she and Dr. Burkus collaborated further on the response to the peer-reviewers</i> of this study during a Lumbar Spine Study Group event.<br /><br />In response to the peer-reviewers’ concerns about bias in the manuscript, <i>the response letter seemingly misled The Spine Journal by stating that 'To help eliminate any potential bias, only one of the co-authors was a clinical investigator—the other three were independent reviewers </i>of all the data. Since these data are taken from a clinical IDE study sponsored by a company, only the company would have all the data in its database—data that is reviewed by FDA auditors. We don’t believe any discussion of bias is needed for the text.'  <i>By the end of 2003, 'independent reviewers' Dr. Haid and Dr. Burkus would have received $7,793,000 and $722,000 from Medtronic, respectively.</i> This draft letter, written at least in part by Medtronic on behalf of Dr. Burkus, did not disclose the company’s role in directly editing the paper nor did it disclose the magnitude of financial payments made to the supposed 'independent reviewers.'</blockquote><br />Thus, in this case, a marketing employee apparently edited a draft of a scholarly article to exaggerate benefits of the company's product, directly adding text to the article, and when peer-reviewers suggested that the article showed bias towards the company's product, apparently two employees ghost-wrote a response letter that claimed that certain authors were "independent reviewers," obfuscating that they had previously received large payments from the company.<br /><br /><b>Summary</b><br /><br />In 2010, we <a href="http://hcrenewal.blogspot.com/2010/12/blogscan-medtronics-multi-million.html">noted</a> reporting that suggested Medtronic had paid huge amounts, millions of dollars, to spine surgeons for reasons that were not clear.  Later that year, we <a href="http://hcrenewal.blogspot.com/2010/12/spine-surgeons-reticent-about.html">noted</a> further reporting that surgeons who were getting amounts sometimes exceeding one million dollars from Medtronic were not disclosing these payments in scholarly articles about the company's BMP-2 product. <br /><br />Now there appears a US Senate committee report alleging that Medtronic marketing employees systematically influenced the writing, editing, and publication of multiple ostensibly scholarly articles, ostensibly written by doctors, to favor the Medtronic In-Fuse BMP-2 product.  This adds to previous case studies suggesting that pharmaceutical, biotechnology, device and probably other kinds of company marketers may try to systematically <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate</a> the design, implementation, analysis, and dissemination of supposedly scholarly and unbiased clinical research to more effectively market their products and services.   <br /><br />This is discouraging to a former full-time academic physician who now realizes that the difficulties I encountered getting my manuscripts published, given that they written entirely by academic investigators and uninfluenced by marketers, may have been due to the cacophony of competition from marketing influenced texts professionally promoted to journals to serve vested interests.<br /><br />This is more discouraging to a proponent of <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">evidence-based medicine</a> who believes that medical decisions ought to be informed by critical review of clinical research obtained by systematic search in order to weigh the benefits and harms of management options,accounting for patients' values.  When that clinical research was being deliberately influenced and biased by people selling goods and services, it is not clear that even rigorous critical review will distill the truth from the injected bias.  Yet if physicians cannot depend on published research to guide their decision making for individual patients, what can they depend on?<br /><br />I conclude as I did my last post,...   Thus health care professionals, policy makers, researchers, and the interested public need to be even more skeptical about arguments made to promote innovative treatments and other clinical interventions.  However, it is not clear that even rigorous skepticism can defend the integrity of evidence based medicine from marketing disguised as clinical research. <br /><br />Going forward, we must consider erecting an impregnable barrier between clinical research and those whose primary interest is to make money by selling health care goods and services.  If we do not do that, we will forever need to worry that we really have no idea what "works in medicine," and whether any particular test, treatment, or program provides benefits that outweigh its harms.  <br /><br />

Marketers' Systemic Influence over Ostensibly Scholarly, Peer-Reviewed Publications: the Medtronic Infuse BMP-2 Example

On the heels of our discussion of how one pharmaceutical company employed a "publications strategy" to commission and control ran...

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Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incentive programs, and other factors as <a href="http://ihealthtran.com/wordpress/2012/10/senate-republicans-send-letter-to-sebelius-with-concerns-over-meaningful-use/" target="_blank">here</a>.<br /><br />However, what was largely left out was the issue of safety.<br /><br />I've written this letter to the congresspeople who've written to HHS secretary Sebelius (PDF available <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/EHR_congress_letter_oct24_2012_final.doc" target="_blank">at this link</a>):<br /><br /><blockquote class="tr_bq"><div class="MsoNormal"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">October 24, 2012</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">To:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Sens. Coburn, Burr, Roberts and Thune</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Reps. Ellmers, Camp, Herger, Upton and Pitts</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">United States</span><span style="font-family: Arial; font-size: 10.0pt;"> Congress</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Washington</span><span style="font-family: Arial; font-size: 10.0pt;">, DC</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Re:<span style="mso-spacerun: yes;">  </span>HITECH and healthcare information technology</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Dear Senators and Representatives,</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">I applaud your recent inquiries to HHS regarding critical issues related to healthcare information technology (EHRs, physician order entry, decision supporting systems, etc.)  Issues such as the possible role of these systems in upcoding and Medicare overbilling, test overutilization, abuse of incentives, etc. must be addressed.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">However, you did not address an issue probably more important to the public, indeed to us all as patients – that of health information technology <i style="mso-bidi-font-style: normal;">safety.</i></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Congress must be made aware that health IT exists in two forms:  <b style="mso-bidi-font-weight: normal;">good health IT </b>and<b style="mso-bidi-font-weight: normal;"> bad health IT</b>.  <span style="mso-bidi-font-weight: bold;">Bad health IT reduces safety, creates close calls, injures, kills, raises costs, and sacrifices information privacy and confidentiality, among other ill effects</span>.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Congress must also be made aware that unfortunately due to systemic impediments to free flow of information about health IT systems and lack of FDA or other independent industry regulation, bad health IT is rarely removed from the marketplace or fixed.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">FDA and its director of the Center for Devices and Radiological Health (CDRH), Jeffrey Shuren MD JD, testified to HHS in Feb. 2010 that “under the Federal, Food, Drug, and Cosmetic Act, health information technology software is a medical device”, but that FDA has “largely refrained from enforcing our regulatory requirements with respect to HIT devices.”  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">To clarify about the two types of health IT:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><b><span style="font-family: Arial; font-size: 10.0pt;">Good Health IT</span></b><span style="font-family: Arial; font-size: 10.0pt;"> provides a good user experience, enhances cognitive function, puts essential information as effortlessly as possible into the physician’s hands, keeps eHealth information secure, protects patient privacy and facilitates better practice of medicine and better outcomes. </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><b><span style="font-family: Arial; font-size: 10.0pt;">Bad Health IT </span></b><span style="font-family: Arial; font-size: 10.0pt;">is ill-suited to purpose, hard to use, unreliable, loses data or provides incorrect data, causes cognitive overload, slows rather than facilitates users, lacks appropriate alerts, creates the need for hypervigilance (i.e., towards avoiding IT-related mishaps) that increases stress, is lacking in security, compromises patient privacy or otherwise demonstrates suboptimal design and/or implementation. </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The Agency for Healthcare Research and Quality (AHRQ) recently reported that the highest prevalence of medical technology safety issues was related to EHR systems.<span style="mso-spacerun: yes;">  </span>Even worse, there is a lack of reporting transparency. Harms are known of, but the magnitude admittedly unknown due to systematic impediments to reporting transparency, collection and analysis, as noted by FDA in a 2010 internal memo and IOM itself in its 2012 report on health IT safety.  This is unprecedented in modern medicine, violates patient’s rights, and under no circumstances should be considered acceptable.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">I personally know of adverse patient outcomes including death related to bad health IT that are unreported (even in a state that mandates reporting of medical incidents and serious events), as do numerous colleagues.<span style="mso-spacerun: yes;">  </span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The Institute of Medicine has just released a Discussion Paper written by experts in health information technology entitled “<b>Comparative User Experiences of Health IT Products: How User Experiences Would Be Reported and Used"  </b>(<a href="http://www.iom.edu/Global/Perspectives/2012/%7E/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf" target="_blank">http://www.iom.edu/Global/Perspectives/2012/~/media/Files/Perspectives-Files/2012/Discussion-Papers/comparative-user-experiences.pdf</a>). The recommendations in this paper need to be put into place, and Congressional awareness of the issues and official inquiry as to when this will happen is essential.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">This paper’s recommendations will not happen without the oversight of Congress.  As stated in the paper itself, “Some medical and IT leaders have invested their reputations, and their organization’s time and money, in the software [implementation] program; complaints that expose large problems may not be appreciated or carried forward.” </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Some claim safeguards are already in place in the form of HHS certification of health IT.  </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Unfortunately, the HHS health IT certification guidelines do not have sufficient depth nor the correct focus to distinguish between bad health IT and good health IT.  Certification for MU does not look at real-world testing for safety, reliability and usability, for instance, under real loads, in actual clinical settings, and is not very thorough.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">On the other hand,  NASA, the pharmaceutical industry (via FDA's regulation of pharmaceutical research and manufacturing IT) and others dependent on mission-critical software have rigorous validation procedures to check for such factors, e.g., NASA’s "<a href="http://ntrs.nasa.gov/archive/nasa/casi.ntrs.nasa.gov/20040014965_2004000657.pdf" target="_blank">Certification Processes for Safety-Critical andMission-Critical Aerospace Software</a>" that includes rigorous testing to distinguish bad IT from good IT, and remediate or abandon the former.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .5in; margin-right: 0in; margin-top: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">p. 6-7:  In order to meet most regulatory guidelines, developers <span style="mso-bidi-font-weight: bold;">must build a safety case</span> as a means of documenting the safety justification of a system. The safety case is a <span style="mso-bidi-font-weight: bold;">record of all safety activities</span> associated with a system throughout its life. Items contained in a safety case include the following:<br /><br />• Description of the system/software<br />• Evidence of <span style="mso-bidi-font-weight: bold;">competence of personnel</span>involved in development of safety-critical software and any safety activity<br />• Specification of <span style="mso-bidi-font-weight: bold;">safety requirements</span><br />• Results of <span style="mso-bidi-font-weight: bold;">hazard and risk analysis</span><br />• Details of <span style="mso-bidi-font-weight: bold;">risk reduction</span>techniques employed<br />• Results of design analysis showing that the <span style="mso-bidi-font-weight: bold;">system design</span> <span style="mso-bidi-font-weight: bold;">meets all required safety targets</span><br />• <span style="mso-bidi-font-weight: bold;">Verification and validation strategy</span><br />• Results of <span style="mso-bidi-font-weight: bold;">all verification and validation activities</span><br />• Records of<span style="mso-bidi-font-weight: bold;"> safety reviews</span><br />• Records of <span style="mso-bidi-font-weight: bold;">any incidents which occur throughout the life of the system</span><br />• Records of all changes to the system and<span style="mso-bidi-font-weight: bold;"> justification of its continued safety</span></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">These processes need to be put in place regarding healthcare IT as well, but will take much time and regulatory push on the industry to occur.  In the absence of truly rigorous testing, though, transparency is essential.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">The aforementioned IOM Discussion Paper outlines the creation of a nationwide post-marketing surveillance process and transparency on health IT usability problems, safety issues, billing fraud promotion, etc. is essential.  It recommends:</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">“Flight simulator”-like, thorough laboratory evaluation of test scenarios;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Point-of-use reporting by doctors and nurses on their experiences;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Third party–administered doctor and nurse surveys about their experiences with EHR systems;</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">Direct clinician-to-public reporting; and</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; margin-left: .75in; margin-right: 0in; margin-top: 0in; mso-list: l0 level1 lfo1; tab-stops: list .75in; text-indent: -.25in;"><span style="font-family: Symbol; font-size: 8.0pt; mso-bidi-font-family: Symbol; mso-bidi-font-size: 10.0pt; mso-fareast-font-family: Symbol;"><span style="mso-list: Ignore;">¨<span style="font: 7.0pt "Times New Roman";">        </span></span></span><span style="font-family: Arial; font-size: 10.0pt;">A formalized system of hazards reporting from EHR systems.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">These measures are essential if the technology is to achieve the benefits of which it is theoretically capable, but not presently achieving despite the hundreds of billions of dollars being spent.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">In conclusion, I ask you to add to your inquiries the subject of health information technology safety.  That includes the need for HHS to develop a robust, transparent national reporting system for safety problems created by the technology, and a system to ensure that bad health IT is either fixed in a timely manner or removed from the marketplace.</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Sincerely,</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Scot Silverstein, MD</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">-----------------------------------------------------------------</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Scot M. Silverstein, MD</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Adjunct faculty in Healthcare Informatics and IT (Sept. 2007-present)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Assistant Professor of Healthcare Informatics and IT, and Director, Institute for Healthcare Informatics (2005-7)</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Drexel</span><span style="font-family: Arial; font-size: 10.0pt;"> University</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">College</span><span style="font-family: Arial; font-size: 10.0pt;"> of Information Science</span><span style="font-family: Arial; font-size: 10.0pt;"> and Technology</span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">3141 Chestnut St.</span><span style="font-family: Arial; font-size: 10.0pt;">, Philadelphia, PA 19104-2875</span><span style="font-family: Arial; font-size: 10.0pt;"></span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><br /></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Email:<span style="mso-spacerun: yes;">  </span>sms88 AT drexel DOT edu </span></div><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;">Bio:<span style="mso-spacerun: yes;">  </span><a href="http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm">http://www.ischool.drexel.edu/faculty/ssilverstein/biography.htm</a> </span></div></blockquote><div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;"><span style="font-family: Arial; font-size: 10.0pt;"></span></div><br /><br />I hope this letter has some beneficial effect.<br /><br />-- SS

Letter To U.S. Senators and Representatives Who've Sought HHS Input On EHR Problems

Several members of Congress have written HHS demanding meetings on health IT issues such as upcoding, test overutilization, misuse of incent...

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When Clinical Trials are Meant for Marketing, not Science

The development of the randomized controlled clinical trial (RCT) was one of the major scientific advances in clinical medicine.  RCTs provide a major part of the evidence underlying evidence based medicine.  RCTs provide a major source of data used by the US Food and Drug Administration, and similar agencies in other countries, to decide whether to approve drugs or devices to manage particular clinical problems.  Unfortunately, with the rise of the RCT came a rise in attempts to <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppress</a> and <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulate</a> clinical trials by those with vested interests, often in selling the products and services the trials can evaluate.<br /><br />Many of the examples we have discussed were of attempts at manipulation or suppression of clinical trials originally done to provide evidence for product approval, or even ostensibly to advance clinical science.  Yet a relatively new article covering evidence revealed from litigation about the drug gabapentin (Neurontin) originally made by Parke-Davis, first a part of Warner Lambert, now part of Pfizer suggests that many clinical trials may not be done to advance science, or even just to provide data to regulators, but only to market products.<br /><br />The article is Vedula SS, Goldman PS, Rona IJ, Greene TM, and Dickersin K. Implementation of a publication strategy in the context of reporting biases: a case study based on new documents from the Neurontin litigation.  Trials 2012; 13: 136.  Link<a href="http://www.trialsjournal.com/content/13/1/136"> here</a>.<br /><br /><b>Methods Summary</b><br /><br />The article described a case study based on documents revealed in 2008 litigation.  The purpose of the study was:<br /><br /><blockquote class="tr_bq">to describe the implementation of a publication strategy for off-label marketing of gabapentin, within the context of reporting biases and spin of Pfizer and Parke-Davis’s clinical trial findings, for four off-label uses: migraine prophylaxis, treatment of bipolar disorders, neuropathic pain, and nociceptive pain. </blockquote><br />The study examined documents revealed through the 2008 litigation.  It concentrated on documents relating to the marketing of Neurontin for four off-label indications, that is, for four potential reasons to use the drug which had not yet been approved by the US FDA.  It focused on documents discussing strategies for marketing for these indications, and then documents about particular company sponsored RCTs done for these indications. <br /><br /><b>Strategies to Sell Drugs</b><br /><br />The documents examined by the investigators showed that Parke-Davis prepared "marketing assessments" for four possible indications for Neurontin.  The assessments discussed two possible strategies.  The "indication strategy" would be to conduct trials for the purposes of providing data to the FDA in the hope that the FDA would then approve the new indication for the drug.  The "marketing strategy" would be, in the words of an internal company memo quoted in the study, to conduct clinical trials and<br /><br /><blockquote class="tr_bq">to disseminate the information as widely as possible through the world’s medical literature</blockquote><br />In other words, the publication strategy involved using RCTs first for marketing, rather than scientific or regulatory purposes. <br /><br /><b>How the Trials were Controlled by Marketers  </b><br /><br />The publication strategy involved not simply doing trials and publicizing their results, but controlling the messages conveyed by the trials to make sure they primarily supported marketing.  This was done by having the company's marketing department control the content of the trial reports.<br /><br /><blockquote class="tr_bq"><i> A Neurontin Publications Subcommittee (NTN PSC) was formed within Pfizer and Parke-Davis to implement a publication plan.</i> Minutes from meetings between the NTN PSC and Medical Action Communications (MAC), a medical writing company, indicate that <i>a list of key messages, guiding the content of published reports related to the trials of gabapentin for off-label indications, was developed based on a branding guide </i></blockquote>Thus it appeared to be that marketers, not physicians or scientists were in control of supposedly scholarly research publications appearing in medical journals. <br /><br />The marketers controlled content by controlling those who wrote it.<br /><br /><blockquote class="tr_bq"> A standard operating procedure related to publication of affiliate-driven manuscripts was identified in internal company documents dated October 16, 2002, and it sheds further light on the publication planning process (see Figure 3<a href="http://www.trialsjournal.com/content/13/1/136/figure/F3"></a>). (The term affiliate in this context refers to Pfizer’s foreign affiliates, that is, corporations related to Pfizer by either shareholdings or other means of control, including subsidiary, parent, or sibling corporations). According to the internal company documents, 'affiliate-driven <i>manuscripts' were written for Pfizer and Parke-Davis by MAC</i> and sent to the authors for approval. <i>Each article was coordinated by a manuscript team, consisting of representatives from the medical and marketing divisions of the company.</i> The documents also indicate that all <i>affiliate-driven manuscripts should be forwarded to the NTN PSC for review. One of the objectives of manuscripts being reviewed by the NTN PSC was to ‘ensure that they are in-line with current product messages and areas of interest’</i></blockquote><b>Manipulating the Dissemination (and Analysis) of Research Results </b><br /><br />Note that the control of publication by marketers describe above involved ghost-writing of articles by medical education and communications companies (MECCs).  Later the article explained that these ghost writers were "not appropriately acknowledged" in the resulting published articles.<br /><br />The Vedula et al study article provided examples of "spin" in the writing of again supposedly scholarly research publications used in fact to support marketing, and controlled if not composed by marketers.<br /><br /><blockquote class="tr_bq"> We identified spin in publications related to 8/12 trials included in our analysis.... We classified the following as spin: <i>emphasis in the published report on outcomes that were not specified in the study protocol</i> (Study 879–201) ...; conclusions that did not match study findings described in the internal company research report (Study 945–220) <a href="http://www.blogger.com/blogger.g?blogID=9551150" name="d7865e503"></a>...; extensive rationale to explain away statistically non-significant (unfavorable to the sponsor) findings (Study 945–209; 945–291; No study number - Gorson) <a href="http://www.blogger.com/blogger.g?blogID=9551150" name="d7865e508"></a><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="d7865e510"></a><a href="http://www.blogger.com/blogger.g?blogID=9551150" name="d7865e512"></a>...; conclusion of treatment effectiveness from an uncontrolled study (Study 945–250) ...; emphasis on statistically significant secondary outcomes despite negative findings for the primary outcome (Study 945–271) ...; and an explicit description of an attempt to spin study findings (as described in internal company emails) (Study 945–306).</blockquote><br />Note that while most of these examples of spin involved manipulation of the dissemination of study results, that is, doubtful, biased or fallacious arguments based on apparently unbiased data, they also involved manipulation of the analyses (in italics). <br /><br />The article also described manipulation of dissemination involving the timing of publication, including delaying publication of an article despite the wishes of the study's investigators because the results were not statistically significant, and hence not favorable for marketing.  <br /><br /><b>Summary</b><br /><br />Documents revealed by litigation about Neurontin in 2004 provided insights about how pharmaceutical and presumably other kinds of health care corporations may conduct systematic, deceptive stealth marketing campaigns to promote their products and services (look<a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html"> here</a>).  We noted that initial media coverage of documents revealed in the 2008 litigation also suggested the existence of a systematic "publication strategy" to control dissemination of results of particular trials, while suppressing trials whose results could not easily be spun to provide support of marketing objectives (look <a href="http://hcrenewal.blogspot.com/2008/10/did-pfizer-marketers-suppress-and.html">here</a>).<br /><br />Now the new paper by Verdula et al fill out our knowledge of this case.  The paper suggests that randomized controlled clinical trials may be done not to advance science, or even convince regulators, but primarily to market their sponsors' products.  Thus some significant proportion of the clinical research literature, the literature that physicians and other health professionals have relied upon to make evidence-based decisions for their patients, may exist mainly for marketing purposes.  Even the most rigorous methods used by clinical epidemiologists to review research are meant to discover problems that arose from human error or the inevitable trade-offs made when research is done in the real world, but not deliberately introduced biases and defects meant to promote vested interests.  Thus it is not clear that even the most "evidence-based" medical decisions are based on real scientific evidence rather than the spinning of marketers.<br /><br />Thus health care professionals, policy makers, researchers, and the interested public need to be even more skeptical about arguments made to promote innovative treatments and other clinical interventions.  However, it is not clear that even rigorous skepticism can defend the integrity of evidence based medicine from marketing disguised as clinical research. <br /><br />Going forward, we must consider erecting an impregnable barrier between clinical research and those whose primary interest is to make money by selling health care goods and services.  If we do not do that, we will forever need to worry that we really have no idea what "works in medicine," and whether any particular test, treatment, or program provides benefits that outweigh its harms.  <br /><br />

When Clinical Trials are Meant for Marketing, not Science

The development of the randomized controlled clinical trial (RCT) was one of the major scientific advances in clinical medicine.  RCTs provi...

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HITECH and Experimental Airplanes

This from a commenter, who has been deeply involved in major governmental health IT initiatives in another land, who wishes to remain anonymous:<br /><br /><blockquote class="tr_bq">The whole HITECH initiative really is getting like the equivalent of loading up a brand new airplane with paying travelers before debugging the software or even putting a model in the wind tunnel, and doing so without FAA approval.<br /><br />If anyone attempted that in aviation, no one and I mean NO ONE would board the plane including the crew and Captain, so why is it OK in healthcare?  Is it just because the avoidable disasters are one body at a time in Health vs. 200-400 at once in air travel?</blockquote><br />The answer to the last question?<br /><br />Yes.<br /><br />-- SS<br />

HITECH and Experimental Airplanes

This from a commenter, who has been deeply involved in major governmental health IT initiatives in another land, who wishes to remain anonym...

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Computer Viruses Are "Rampant" on Medical Devices in Hospitals

As if there weren't enough problems with hospitals as computing backwaters, now there's this:<br /><br /><blockquote class="tr_bq"><a href="http://www.technologyreview.com/news/429616/computer-viruses-are-rampant-on-medical-devices/" target="_blank"><b>Computer Viruses Are "Rampant" on Medical Devices in Hospitals</b></a><br /><br />A meeting of government officials reveals that medical equipment is becoming riddled with malware.<br /><br />Technology Review<br />Published by MIT<br />David Talbot<br />Wednesday, October 17, 2012 <br /><br />Computerized hospital equipment is increasingly vulnerable to malware infections, according to participants in a recent government panel. These infections can clog patient-monitoring equipment and other software systems, at times rendering the devices temporarily inoperable.<br /><br /><b>While no injuries have been reported</b>, the malware problem at hospitals is clearly rising nationwide, says Kevin Fu, a leading expert on medical-device security and a computer scientist at the University of Michigan and the University of Massachusetts, Amherst, who took part in the panel discussion.</blockquote><br />I note the seemingly universal refrain<b> </b>"<b>no injuries have been reported</b>" once more (see <a href="http://hcrenewal.blogspot.com/search/label/Patient%20care%20has%20not%20been%20compromised" target="_blank">this query link</a> to similar statements regarding IT malfunctions), which is irrelevant since reporting mechanisms for medical errors are <a href="http://www.seattlepi.com/local/article/Despite-law-medical-errors-likely-go-unreported-889076.php" target="_blank">noted to be deficient</a>.<br /><br /><blockquote class="tr_bq">Software-controlled medical equipment has become increasingly interconnected in recent years, and many systems run on variants of Windows, a common target for hackers elsewhere. The devices are usually connected to an internal network that is itself connected to the Internet, and they are also vulnerable to infections from laptops or other device brought into hospitals.  <b><span style="color: red;"><i>[I note that it should be impermissible to connect "alien" machines to a hospital<span style="color: black;">'s</span> network without authorization, and that attaining that level of security protection is not difficult - ed.] </i></span> </b>The problem is exacerbated by the fact that manufacturers often will not allow their equipment to be modified, even to add security features.<br /><br />In a typical example, at Beth Israel Deaconess Medical Center in Boston, 664 pieces of medical equipment are <b>running on older Windows operating systems that manufactures will not modify or allow the hospital to change</b>—even to add antivirus software—because of disagreements over whether modifications could run afoul of U.S. Food and Drug Administration regulatory reviews, Fu says.</blockquote><br />In other words, let's run at high risk if it avoids the time and expense of FDA reviews that would ensure the equipment is safe and operates as expected with the software updates.<br /><br /><blockquote class="tr_bq">As a result, these computers are frequently infected with malware, and one or two have to be taken offline each week for cleaning, says Mark Olson, chief information security officer at Beth Israel.</blockquote><br />It is unclear how the servers running the hospital information system, electronic health records systems, physician order entry systems etc. are immune to spread of the malware.<br /><blockquote class="tr_bq"><br />"I find this mind-boggling," Fu says. "Conventional malware is rampant in hospitals because of medical devices using unpatched operating systems. There's little recourse for hospitals when a manufacturer refuses to allow OS updates or security patches."<br /><br />The worries over possible consequences for patients were described last Thursday at a meeting of a medical-device panel at the National Institute of Standards and Technology Information Security and Privacy Advisory Board, of which Fu is a member, in Washington, D.C. At the meeting, Olson described <b>how malware at one point slowed down fetal monitors used on women with high-risk pregnancies being treated in intensive-care wards.</b></blockquote><br />In its face, that is potentially catastrophic depending on the degree of "slowdown" and whether data is lost.<br /><br /><blockquote class="tr_bq"><b>"It's not unusual for those devices, for reasons we don't fully understand, to become compromised to the point where they can't record and track the data,</b>" Olson said during the meeting, referring to high-risk pregnancy monitors. "Fortunately, we have a fallback model because they are high-risk [patients]. They are in an IC unit—there's someone physically there to watch. <b>But if they are stepping away to another patient, there is a window of time for things to go in the wrong direction."</b></blockquote><br />The reasons seem obvious to anyone who's had a serious malware infection on their PC.  I've only had one - a computer I bought at a fleamarket for $7 was so severely infected it was unusable for even basic tasks, and was resistant to virus removal.  I solved that problem by installing a fresh copy of the OS, immediately followed by all patches and the latest anti-malware software.<br /><br /><blockquote class="tr_bq">The computer systems at fault in the monitors were replaced several months ago by the manufacturer, Philips; the new systems, based on Windows XP, have better protections and the problem has been solved, Olson said in a subsequent interview.</blockquote><br />This implies the older systems were running on Win 98 or earlier or an old version of Win NT.  Amazing.<br /><br /><blockquote class="tr_bq">At the meeting, Olson also said similar problems threatened a wide variety of devices, ranging from compounders, which prepare intravenous drugs and intravenous nutrition, to picture-archiving systems associated with diagnostic equipment, including massive $500,000 magnetic resonance imaging devices.<br /><br />Olson told the panel that infections have stricken many kinds of equipment,<b> raising fears that someday a patient could be harmed.</b> "We also worry about situations where blood gas analyzers, compounders, radiology equipment, nuclear-medical delivery systems, could become compromised to where they can't be used, or they become compromised to the point where their values are adjusted without the software knowing," he said. He explained that when a machine becomes clogged with malware, it could in theory "miss a couple of readings off of a sensor [and] erroneously report a value, which now can cause harm."</blockquote><br />I opine that harm could already have occurred; it just may not been recognized as such nor reported.  Disappearing data and other EHR failure modes known to have caused harm and/or deaths could be related to malware, for example.<br /><br /><blockquote class="tr_bq">... Malware problems on hospital devices <b>are rarely reported to state or federal regulators</b>, both Olson and Fu said. This is partly because hospitals believe they have little recourse. Despite FDA guidance issued in 2009 to hospitals and manufacturers—encouraging them to work together and stressing that eliminating security risks does not always require regulatory review—many manufacturers interpret the fine print in other ways and don't offer updates, Fu says. And such reporting is not required unless a patient is harmed. "Maybe that's a failing on our part, that we aren't trying to raise the visibility of the threat," Olson said. "But I think we all feel the threat gets higher and higher."</blockquote><br />I note that health IT related problems are also rarely reported, with only one vendor being the exception (see my post on the <b>FDA MAUDE</b> voluntary reporting database <a href="http://hcrenewal.blogspot.com/2011/01/maude-and-hit-risk-mother-mary-what-in.html" target="_blank">here</a>).  The reasons likely are not because "hospitals believe they have little recourse" - the real reasons may be fear, complacency and/or incompetence.<br /><blockquote class="tr_bq"><br />Speaking at the meeting, Brian Fitzgerald, an FDA deputy director, said that in visiting hospitals around the nation, he has found Beth Israel's problems to be widely shared. <b>"This is a very common profile," </b>he said. The FDA is now reviewing its regulatory stance on software, Fitzgerald told the panel. "This will have to be a gradual process, because it involves <b>changing the culture,</b> changing the technology, bringing in new staff, and making a systematic approach to this," he said.</blockquote><br />Changing the culture would be nice, considering we are now entering a national rollout of complex enterprise clinical resource and workflow control systems anachronistically known as "electronic medical records."<br /><br /><blockquote class="tr_bq">In an interview Monday, Tam Woodrum, a software executive at the device maker GE Healthcare, said manufacturers are in a tough spot, and the problems are amplified as hospitals expect more and more interconnectedness. He added that despite the FDA's 2009 guidance, regulations make system changes difficult to accomplish: "In order to go back and update the OS, with updated software to run on the next version, <b>it's an onerous regulatory process."</b></blockquote><br />My comment is, if you can't take the heat of work in the real-world medical setting, if you cannot be part of the medical team, then get out of the clinic.  You're likely to do more harm than good.<br /><br /><blockquote class="tr_bq">John Halamka, Beth Israel's CIO and a Harvard Medical School professor, said he began asking manufacturers for help in isolating their devices from the networks after trouble arose in 2009: the Conficker worm caused problems with a Philips obstetrical care workstation, a GE radiology workstation, and nuclear medical applications that "could not be patched due to [regulatory] restrictions." He said, "No one was harmed, but we had to shut down the systems, clean them, and then isolate them from the Internet/local network."<br /><br />He added: "<b>Many CTOs <span style="color: red;"><i>[chief technology officers - ed.]</i></span> are not aware of how to protect their own products with restrictive firewalls</b>. All said they are working to improve security but have not yet produced the necessary enhancements."</blockquote><br />Then why are they CTO's?<i><b> </b></i> Is this the phenomenon of generic or underqualified managers rearing its head?<i><b><br /></b></i><br /><blockquote class="tr_bq"><br />Fu says that medical devices need to stop using insecure, unsupported operating systems. "More hospitals and manufacturers need to speak up about the importance of medical-device security," he said after the meeting. "<b>Executives at a few leading manufacturers are beginning to commit engineering resources to get security right</b>, but there are thousands of software-based medical devices out there."</blockquote><br />One can only wonder if others have done a Ford Pinto cost-benefit analysis and decided the costs of settlement from injured and dead patients is less than the cost of remediation. <br /><br />-- SS

Computer Viruses Are "Rampant" on Medical Devices in Hospitals

As if there weren't enough problems with hospitals as computing backwaters, now there's this: Computer Viruses Are "Rampant...

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