healthy4u: ghost writing

What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

Introduction - New Leadership for the US Department of Veterans Affairs After reports of problems with access, manipulation of data about waiting times, and most recently "a corrosive culture," the US Department of Veterans Affairs, the country's large government run health system, has had a massive leadership overhaul.  President Obama's nominee to head the agency is now Robert A McDonald, former CEO of Procter and Gamble. The choice of a former CEO or a large corporation was called "unorthodox" <a href="http://www.bostonglobe.com/news/nation/2014/06/29/bob-mcdonald-former-chief-obama-nominee-lead-veterans-affairs/zVA9EH7PlMNWaTU7Yyp8NP/story.html">by the Boston Globe</a>, but many saw merit in a business leader running the VA.  As reported by the Globe, House Speaker John Boehner said that as a "private sector" leader,  Mr McDonald is the "kind of person who is capable of implementing the kind of dramatic systemic change that is badly needed and long overdue at the VA."  The Chairman of Boeing, also a member of the P&G board, hailed Mr McDonald as the person who "navigated Procter & Gamble through the difficult post-financial-crisis years, where he expanded business in developing markets and made substantial progress improving the efficiency of the company’s internal operations...." On the other hand, a <a href="http://www.washingtonpost.com/politics/federal_government/obamas-choice-for-va-will-find-fixing-it-is-harder-than-selling-soap/2014/07/01/84cf28d6-0139-11e4-b8ff-89afd3fad6bd_story.html">column in the Washington Post</a> suggested that expertise in "selling Tide and Pantene" might not be relevant to fixing the VA. Yet aside from a <a href="http://ringoffireradio.com/2014/07/obama-nominates-former-corporate-exec-as-veteran-affairs-secretary-2/">single article</a> on the Ring of Fire web site, all news coverage and discussion so far has ignored Mr McDonald previous experience in health care leadership, but also that his relevant track record ought to raise questions about his fitness for the VA position. Procter and Gamble and Health Care According to Mr McDonald's <a href="http://www.pg.com/en_US/downloads/company/executive_team/bios/pg_executive_bio_bob_mcdonald.pdf">official P&G biograpy</a>, after various roles in various countries, before becoming CEO,  <blockquote class="tr_bq">Bob returned to the U.S. as the Vice Chairman of Global Operations (2004 to 2007) and later P&G’s Chief Operating Officer (2007 to 2009).</blockquote> Although not widely known as a pharmaceutical company, P&G actually had a subsidiary that made prescription drugs, which Mr McDonald sold off in 2009 (see this <a href="http://online.wsj.com/news/articles/SB125111032092353427">Wall Street Journal report</a>.)  As we noted <a href="http://hcrenewal.blogspot.com/2014/05/abort-retry-fail-lancet-avoided-much.html">here</a>, its products still include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just <a href="http://www.cincinnati.com/story/money/business/2014/05/02/pg-sells-concierge-medicine-unit/8622903/">reported</a>, it will soon sell this unit to private equity.  So during Mr McDonald's tenure, his company was to some extent a pharmaceutical company, and a health care provider. The Blumsohn - Procter and Gamble - Sheffield University Case Furthermore, on Mr McDonald's watch as Vice Chairman of Global operations and Chief Operating Officer, there was a case involving Procter and Gamble that raised multiple concerns about the ethics of its pharmaceuticals operations.  We first posted about the case in 2005 (<a href="http://hcrenewal.blogspot.com/2005/12/another-challenge-to-integrity-of.html">here</a>).  For all relevant posts, look <a href="http://hcrenewal.blogspot.com/search/label/Actonel">here</a>. In 2009 we <a href="http://hcrenewal.blogspot.com/2009/12/british-medical-journal-interviews-dr.html">described the case</a> thus, <blockquote class="tr_bq">The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.</blockquote> We previously <a href="http://hcrenewal.blogspot.com/2009/09/reappearance-of-ghost-of-seasons-past.html">summarized</a> the case's events <blockquote><ul><li>Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (<a href="http://www.actonel.com/index.jsp">Actonel</a>, made by Procter & Gamble Pharmaceuticals [P&G]) under a <a href="http://www.fraudinscience.org/PG/contract.pdf">contract</a> between P&G and the University.</li><li>Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.</li><li>Despite numerous requests, (like <a href="http://www.fraudinscience.org/PG/20050525mckay.pdf">this one</a>), P&G <a href="http://www.fraudinscience.org/PG/20030619email.htm">refused access </a>to this data <a href="http://www.fraudinscience.org/PG/attorneyreq.pdf">repeatedly</a>. Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.</li><li>Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially <a href="http://www.fraudinscience.org/PG/20030909audio.htm">related to a graph shown to him that omitted 40% of patient data</a>.</li><li>Blumsohn objected to <a href="http://www.fraudinscience.org/PG/20030424email.htm">P&G arranging for papers and abstracts to be written by a professional writer</a>, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.</li><li><a href="http://www.fraudinscience.org/PG/20030910audio.htm">Eastell warned Blumsohn </a>not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."</li><li>After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including <a href="http://www.fraudinscience.org/PG/20040526eastell.pdf">Eastell</a>, medical school Dean <a href="http://www.fraudinscience.org/PG/20050708weetman.pdf">Tony Weetman</a>, University Vice-Chancellor <a href="http://www.fraudinscience.org/PG/20050814bouche.pdf">Robert Boucher</a>, and the Head of the University's Department of Human Resources, <a href="http://www.fraudinscience.org/PG/20050627boucha.pdf">Ms R Valerio</a>.</li><li>Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then <a href="http://www.fraudinscience.org/PG/gag.doc">offered him a severance agreement </a>if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.</li></ul></blockquote><blockquote>So the case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research.</blockquote> Although this case occurred in the UK, it involved actions by the US based Procter and Gamble.  While many of the events in the case occurred before 2004, from 2004 to 2009 it became clear that Procter and Gamble was not going to go easy on Dr Blumsohn.  For example, <a href="http://scientific-misconduct.blogspot.com/2007/03/advice-to-p-pharmaceuticals-how-not-to.html">according to Dr Blumsohn</a>, in 2006, P&G released some scientific data relevant to the case, but not complete enough data to be meaningful.  In 2007, there was still shady business going on involving scientific abstract submissions apparently made in Dr Blumsohn's name by P&G operatives. Since Procter and Gamble never made any known attempt to apologize, explain its conduct, or ameliorate Dr Blumsohn's plight during 2004 - 2009, as one of the most senior leaders of Procter and Gamble, seemingly with direct authority over its pharmaceutical operations in the UK during that time period, Mr McDonald ought to be held accountable for the company's misbehavior described above.  To my knowledge, though, no one at P&G, including Mr McDonald, has ever admitted responsibility or been made accountable in any way.   Summary Since Mr McDonald recently was an executive of a company that sold prescription and non-prescription pharmaceuticals, and provided direct health care, confirmation as Veterans Affairs secretary could be regarded as a transit through the revolving door, and hence open to question.  Since Mr McDonald got $15,928,015 in total compensation during his last year as CEO (2012-13) (see the company's 2013 proxy statement), and had accumulated 2,247,593 shares of stock or equivalent by 2013, worth approximately $179 million at today's price of $79.67, his ability to understand the needs of the often poor veterans whom the VA serves is also open to question.  More importantly, while Mr McDonald held high executive positions at Procter and Gamble, the company was involved in a dodgy affair involving conflicts of interest, manipulation of research, and attempted silencing of whistle blowers.  In my humble opinion, given that these events occurred directly on his watch, his fitness to run a huge health care system ought to be in question unless his responsibility for these events is disproved. The widespread huzzahs for Mr McDonald as potential VA leader based mainly on his exalted status as CEO of a big corporation show that many in the US still see corporate CEOs as aristocracy.  True health care reform would hold health care leaders accountable, particularly for upholding the health care mission and putting patients' and the public's health ahead of revenue generation and especially personal profit. ADDENDUM (7 July, 2014) - Link to McDonald's official P&G biography fixed.  ADDENDUM (8 July, 2014) - This post has been re-posted <a href="http://www.nakedcapitalism.com/2014/07/obama-va-robert-macdonald-procter-gamble-scandal.html">on Naked Capitalism</a>, and <a href="http://www.openhealthnews.com/story/2014-07-07/robert-mcdonald-fit-be-va-secretary">on Open Health News</a>.

What Does the Blumsohn - Procter and Gamble -Sheffield University Affair Say About the Fitness of the Latest VA Secretary Candidate?

Introduction - New Leadership for the US Department of Veterans Affairs After reports of problems with access, manipulation of data about waiting times, and most recently "a corrosive culture," the US…

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02 Jul 2014

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." The report was <a href="http://online.wsj.com/article/SB10001424052970204530504578076993827301944.html">summarized</a> by the Wall Street Journal, <blockquote class="tr_bq">A report by the Senate Finance Committee based on thousands of documents it subpoenaed from Medtronic Inc raises new questions about the integrity of the medical research underpinning one of the medical-device maker's products. Medtronic was 'heavily involved in drafting, editing and shaping the content of medical journal articles' about the product—a bone-growth protein used in spine surgery called Infuse—even as it was paying the physicians who wrote those articles a total of $210 million for unrelated work, the Senate report alleges. In one instance, a Medtronic employee recommended to one of the physicians not publishing a list of side effects associated with Infuse in a 2005 journal article, company emails show. Medtronic marketing officials also urged inserting language into other journal articles touting the use of Infuse as better for patients than using bone harvested from their pelvises because of the pain associated with the latter, other company documents show. Medtronic's influence extended to preparing a physician's 2002 speech to a panel advising the Food and Drug Administration 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. 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>The Extent of the Problem 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. 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. Obfuscating Adverse Effects 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]: <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), recommended that 'significant detail' concerning adverse event  data should not be published. On June 16, 2004, Dr. Julie Bearcroft, Director of Technology Management in Medtronic’s Biologics Marketing Department, 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 don’t think significant detail on this section is warranted.'  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 it is appropriate to simply report the adverse events were equivalent in the two groups without the detail.' 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. 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.' 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, 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.   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> 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. 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.  Emphasizing the Adverse Effects of an Alternative to Using the Company's Product 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. <blockquote class="tr_bq">Documents show that Medtronic edited draft publications to stress the pain patients experienced from undergoing a bone graft procedure instead of receiving InFuse. Medtronic markets InFuse as a less painful alternative to bone graft procedures for patients undergoing spinal fusion surgery.</blockquote> In particular, <blockquote class="tr_bq">After receiving a draft of an early InFuse study 52 to review in October 2001, Medtronic’s Neil Beals, whose 'primary job responsibility was to manage Biologics marketing programs and initiatives,'  recommended that the physician authors of the study emphasize pain experienced by patients who received the bone graft. 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 '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.'   Again, after reviewing a later draft of the study, Beals asked Dr. Burkus on March 8, 2002, 'would it be appropriate to make a bigger deal out of donor site pain 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 exposing the patient to the adverse effects associated with that procedure.' 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, '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.  [sic] [emphasis in original]. In an e-mail to his colleague, Beals wrote, '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 ).  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, some patients continued to experience residual pain at the donor site, and rated the appearance of the site as only fair.'</blockquote> 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.  Deceptive Response to Peer Reviewers' Criticisms of Apparent Bias  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. In summary, <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 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 named on the paper.</blockquote> 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: <blockquote class="tr_bq">In a January 10, 2003, e-mail to Dr. Burkus, Rick Treharne wrote, 'In looking over the data, I was impressed with how well the BMP patients actually did. So much so that I added a few paragraphs at the end that you may not agree with.' </blockquote>However, the reviewers were skeptical, <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> Then, Medtronic employees then took over the process of responding to this review, to wit, <blockquote class="tr_bq">E-mail correspondence on May 28, 2003, indicates that Medtronic’s Rick Treharne wrote and sent Dr. Burkus a draft letter to Dr. Tom Mayer, Editor-in-Chief of The Spine Journal, to address concerns raised by orthopedic surgeons tasked with peer-reviewing the submitted PLIF paper. A subsequent e-mail by Julie Bearcroft notes that she and Dr. Burkus collaborated further on the response to the peer-reviewers of this study during a Lumbar Spine Study Group event. In response to the peer-reviewers’ concerns about bias in the manuscript, 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 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.'  By the end of 2003, 'independent reviewers' Dr. Haid and Dr. Burkus would have received $7,793,000 and $722,000 from Medtronic, respectively. 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> 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. Summary 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. 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.   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. 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? 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. 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.

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 randomized controlled trials to serve marketing purposes, a US Senate comm…

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25 Oct 2012

Is the Meaningful Use Stage 2 Final Rule invalid?

Here are a few reasonable questions I decided to elevate as a post of its own. In the face of the discovery of industry influence over comments submitted to ONC regarding Meaningful Use Stage 2, as I documented at my post earlier today "<a href="http://hcrenewal.blogspot.com/2012/08/health-it-vendor-epic-uses-clients-as.html">Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?</a>" (<a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing" target="_blank">ghost writing</a>, in effect, by those with obvious conflicts of interest): <ul><li> Is the MU Stage 2 Final Rule invalid due to the influence the industry had on the submitted "public" comments and opinions, supposedly by and of the submitters, which are now demonstrably tainted?</li><li> Should an investigation be opened?</li></ul> After all, as I pointed out on Aug. 29 in "<a href="http://hcrenewal.blogspot.com/2012/08/the-scientific-justification-for.html" target="_blank">The Scientific Justification for Meaningul Use, Stage 2: The NWB Methodology</a>", not only is MU2 based on an admitted "nevertheless, we believe" justification (that is, lack of scientific rigor), but now it appears the legislation is based on stealth lobbying and resultant regulatory capture, ONC in essence doing the seller's bidding. Tens of billions of taxpayer dollars are at issue here. -- SS

Is the Meaningful Use Stage 2 Final Rule invalid?

Here are a few reasonable questions I decided to elevate as a post of its own.In the face of the discovery of industry influence over comments submitted to ONC regarding Meaningful Use Stage 2, as I d…

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31 Aug 2012

Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

<div style="text-align: left;">Note: Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at <a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html">http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html</a>.</div> ----------------------- From the Histalk blog in the 8/31/12 news <a href="http://histalk2.com/2012/08/30/news-83112/" target="_blank">at this link</a>: <blockquote class="tr_bq">Epic not only submitted MU Stage 2 comments to ONC, it even helpfully distributed them to their customers so they could submit the same comments under their own names. <a href="http://dclunie.blogspot.com/2012/08/why-onc-whimped-out-annotated.html" target="_blank">David Clunie</a> noticed this and lists the hospitals who sent in the boilerplate, including University of Miami, which submitted the same comments five times without noticing the “Remove Before Submitting” headline that prefaced Epic’s explanation of why its customers should share its opinions with Uncle Sam.</blockquote> From the primary source linked in the Histalk note: <blockquote class="tr_bq"><a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0147" target="_blank">Epic via University of Michigan Health System Meaningful Use Workgroup</a> also the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0241" target="_blank">same Epic comments from University of Miami</a> (who liked them so much they <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0241" target="_blank">submitted it twice</a> and then a <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0326" target="_blank">third time</a> and then a <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0313" target="_blank">fourth</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0299" target="_blank">fifth</a> time) and again from the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0123" target="_blank">Martin Health System</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0137" target="_blank">Metro Health Hospital</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0306" target="_blank">The Methodist Hospitals</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0404" target="_blank">Fairview Health Services</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0358" target="_blank">Sutter Health</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0338" target="_blank">Parkview Health System</a> and the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0284" target="_blank">Everett Clinic</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0255" target="_blank">Dayton Childrens'</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0254" target="_blank">UMDNJ</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0243" target="_blank">NYU Langone Medical Center</a> and <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0142" target="_blank">Hawaii Pacific Health</a> and finally as submitted by <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0285" target="_blank">Epic themselves</a> - others like the <a href="http://www.regulations.gov/#%21documentDetail;D=HHS-OS-2012-0004-0158" target="_blank">Community Health Network</a> just stated they had read and agreed with Epic's comments - Imaging - concur that DICOM is not needed for that objective and PACS images do not need to be duplicated - concerned about single sign on if two systems - View, Download and Transmit to 3rd Party - images are not in the EHR but the PACS - patients would need DICOM viewers - size of the images is a problem - disks are better (also if you look at some copies of this, there are some pretty funny "remove before submitting to ONC" notes that say things like which versions support what and how much it would cost to retrofit, etc.; how embarrassing, both for Epic and their lackeys at these institutions)</blockquote> I certainly admire David Clunie's endurance at being able to slog through all of that and appreciate his shedding some sunlight on the "remove before submitting" notes, but - I don't think it's funny at all. Among other things, it represents taint of the submissions via <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing" target="_blank">ghostwriters</a> (unattributed authors) with obvious <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest" target="_blank">conflicts of interests</a>, topics often addressed at HC Renewal. Here's an example I verified, the submission to the government from Dayton Children's Hospital: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEirxuPSNKvfNLmw5qDGu4JlMVP-MPi6cFKz36m3M_3lZOGY90p1U3Tw36P-mHfyXcyEVGviytPAI6tSdBcvjEgKryW9vAZbve_nooHA5H5vj4Fhdgt7Zn83CBGGrHw6qAX9nedacFQbfZxS/s1600/remove_before_submitting.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="348" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEirxuPSNKvfNLmw5qDGu4JlMVP-MPi6cFKz36m3M_3lZOGY90p1U3Tw36P-mHfyXcyEVGviytPAI6tSdBcvjEgKryW9vAZbve_nooHA5H5vj4Fhdgt7Zn83CBGGrHw6qAX9nedacFQbfZxS/s400/remove_before_submitting.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">"Informational Comments for Organizations Using EPIC (remove before submitting to ONC)" - click to enlarge.  At least here they say they are "in total agreement" with EPIC's concerns and recommendations.  </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td><td class="tr-caption" style="text-align: center;"> </td></tr></tbody></table> Another example - University of Miami: <table align="center" cellpadding="0" cellspacing="0" class="tr-caption-container" style="margin-left: auto; margin-right: auto; text-align: center;"><tbody><tr><td style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgOJPENnCLi6R2iGZR_GWK9akDzTBYxtYsy5YZi0rONJsZqF8FSCNxjVeO1MUYeGQLEHOqG8vndOhgb2rUn9OWCSMUNLLXGrtAjJAE9CNRdd4WLijC4RFOjLwEvXwoV4B2pF_awkyAzyTLl/s1600/miami.bmp" imageanchor="1" style="margin-left: auto; margin-right: auto;"><img border="0" height="392" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgOJPENnCLi6R2iGZR_GWK9akDzTBYxtYsy5YZi0rONJsZqF8FSCNxjVeO1MUYeGQLEHOqG8vndOhgb2rUn9OWCSMUNLLXGrtAjJAE9CNRdd4WLijC4RFOjLwEvXwoV4B2pF_awkyAzyTLl/s400/miami.bmp" width="400" /></a></td></tr><tr><td class="tr-caption" style="text-align: center;">A danger of dealing with incompetents:  they neglect to tidy up for you - click to enlarge.  (Corollary question: note the line "Our [Epic's - ed.] comments stem from the fact the we believe ..."  So - what opinions belong to the 'public commenting organization', and which to the company?  Likely the whole thing belongs to the latter's ghostwriters, but can anyone really tell?  That's the problem with tainted submissions.)</td></tr></tbody></table> Others is the links above I checked such as Martin and Methodist have the same boilerplate about the "chart search feature."  Some retain the "reminder" to remove; in others it has been erased.  However, the boilerplate remains. I actually find the "advice" from EPIC in the latter document stunning regarding a "chart search feature" (e.g., search note text, and probably also ad hoc clinical searches such as 'find my patients whose blood sugars have been > 100 in the past month').  These are "features" critical to quality care that should have been present decades ago ** [see note below].  Emphasis mine: <blockquote class="tr_bq">... Focus certification on the minimum floor set of capabilities required to complete meaningful use objectives. </blockquote> Is this a tacit admission "certification" is a sham?  Is this in patients' best interests? and <blockquote class="tr_bq">Informational Comments for Organizations Using Epic (remove before submitting to ONC) We’ve heard your requests for a chart search feature, and our desire to see this certification criterion removed does not mean we don’t want to develop such a feature. In a future version of Epic, we want to develop the best possible chart search feature based on your input. However, if this criterion stays in the Final Rule, we worry we’ll have to divert attention from future chart search features you’ve requested to focus on a simplified, less valuable version of the feature to meet certification. </blockquote> In my opinion, this translates to: "we are already overextended, so help us stymie the experts' and government's efforts to make it a criteria for certification, and to hell with your doctors and nurses who need a search feature right now." Can you imagine in 2012 a word processor, database or operating system without a search feature?  That's the kind of antediluvian IT the clinicians have to put up with.  And this industry speaks of "innovation?" It would come as no surprise - to me, at least - if other health IT sellers were engaged in similar activities. I am unable to judge whether stealth lobbying by sellers using their clients, which enables the sellers to then line their pockets through favorable government legislation based on echoed comments of clients, is legal or ethical.  My belief, however,  is that it is at best a questionable practice.  It is certainly inherently unfair e.g., anti-competitive in regard to smaller health IT companies who might be able to meet more stringent MU2 certification criteria, and unfair to private citizens who have no such captive mouthpieces at their beck and call.  While perhaps not as bad as possible 'Combination in Restraint of Trade' as in my April 2010 post "Healthcare IT Corporate Ethics 101" (<a href="http://hcrenewal.blogspot.com/2010/04/healthcare-it-corporate-ethics-101.html" target="_blank">link</a>), this situation should probably be brought to the attention of health IT watchdogs such as Sen. Grassley. This May 2012 post might also be of interest:  <a href="http://hcrenewal.blogspot.com/2010/05/did-epic-ceo-judy-faulkner-of-epic.html" target="_blank">Did EPIC CEO Judy Faulkner of Epic declare that 'healthcare IT usability would be part of certification over her dead body'?</a>  ONC never responded to the questions I raised in the post. Another question:  why did ONC apparently turn a blind eye towards these "accidental inclusions"?  Yet another question:  is the MU2 Final Rule invalid due to the influence the industry clearly had on the submitted "public" comments, which can now reasonably be viewed as tainted? -- SS Addendum: I've informed the Senator via his email and staff voicemail lines.  I've also created a short URL to more conveniently access this post:  <a href="http://www.tinyurl.com/epic-stealth">http://www.tinyurl.com/epic-stealth</a> Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at <a href="http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html">http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html</a>. -- SS Note: ** For instance, I had  implemented a robust search feature of clinical notes, all comment fields and the comprehensive clinical, genetic and genealogical dataset in the Yale-Saudi Clinical Genetics EHR - in 1995.

Health IT Vendor EPIC Caught Red-Handed: Ghostwriting And Using Customers as Stealth Lobbyists - Did ONC Ignore This?

Note: Also see the followup Sept. 5, 2012 post "Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?" at http://hcrenewal.blogspot.com/2012/09/from-what-i-can-tell-epic-was.html…

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31 Aug 2012

Guest Blog: Health Care in Dangerous Times

Health Care Renewal presents another guest blog by Steve Lucas, a retired businessman who formerly worked in real estate and construction who has a long standing interest in business ethics, and has long observed the health care scene. <a href="http://hcrenewal.blogspot.com/">Health Care Renewal </a>has often covered the disconnect between the stated goals of companies and the realities of their day to day operations. This raised the following question: Has medicine moved from being dysfunctional to being dangerous? There is certainly no lack of material to support this question as in the last two weeks we can find examples of pharma/biotech/device companies all engaged in questionable behavior. Medtronic and Manipulation of Study Data In the print media, The Wall Street Journal, a pro-business newspaper regularly highlights stories questioning the actions of companies. In the June 29 <a href="http://online.wsj.com/article/SB10001424052702303627104576413663395567784.html">story</a> titled "Medtronic Surgeons Held Back, Study Says" by John Carreyrou and Tom McGinty we find doctors being paid by Medtronic held back information regarding negative out comes of a bone growth product. <blockquote>'Medtronic paid millions to doctors and those same doctors, oddly enough, published the 'science' Medtronic needed to sell a product,' says Paul Thacker, a former aide to Sen. Charles Grassely…'</blockquote> Chantix's Cardiac Adverse Effects In the July 5 <a href="http://online.wsj.com/article/SB10001424052702304803104576425634260856212.html">story</a>, "Pfizer Drug Tied To Heart Risk" by Thomas M. Burton covers the increased cardiovascular problems with Chantix that only now seemingly have become evident. <blockquote>However, J. Taylor Hays, a Mayo Clinic doctor who has received funding from Pfizer for research on Chantix, responded in a commentary, 'The risk for serious cardiovascular events is low and is greatly outweighed by the benefits of diminishing the truly 'heartbreaking' of smoking.'</blockquote>The article then continues: <blockquote>'Some people have had changes in behavior, hostility, agitation, depressing mood, suicidal thoughts or actions while using Chantix to help them quit smoking,' Pfizer says in safety information.</blockquote> Overuse of Cardiac Stents In the July 6 <a href="http://online.wsj.com/article/SB1000142405270230476060457642832.html">article</a>, "Heart Treatment Overused" by Ron Winslow and John Carreyrou we find the over use of stents and the profit potential for doctors and hospitals. <blockquote>Outside of heart attacks, doctors are often quick to use a common $20,000 procedure to treat patients suffering from coronary artery disease, a new study suggest.</blockquote> Untested Imported Drug Ingredients In the July 6 <a href="http://online.wsj.com/article/SB10001424052702303339904576406163574698.html">Op-ed</a>, "Beware the Risk of Generic Drugs" by Roger Bate reinforces a point made often on Health Care Renewal when he covers the importation of untested or tainted product used in our pharmaceuticals. <blockquote>China is now the largest supplier of pharmaceutical chemicals – hundreds of tons annually – to the world. And pharmaceutical companies that buy these chemicals do not test them.</blockquote> Moving on to widely read blogs, Ghost Writing and Risperdal 1BoringOldMan in his <a href="http://1boringoldman.com/index.php/2011/07/03/bipolar-kids-postscript-detestable/">post</a> on bipolar kids and the doctors involved in the Harvard debacle discussed an article favorable to the drug ostensibly written by Harvard Professor Josephy Biederman: <blockquote>This covers the reworking of a previously done study to promote the use of drugs in children with this printed at the bottom of the first page: “"Printed in the USA. Reproduction in whole or part is not permitted. Copyright © 2006 Excerpta Medica, Inc."</blockquote> 1BoringOldMan continues with this <a href="http://1boringoldman.com/index.php/2011/07/06/in-tears-and-despair">post</a> that since we have identified children as bipolar we are free to ignore other factors and simply medicate them to death. <blockquote>As reported by '60 Minutes' in September of last year, Rebecca Riley died on December 13, 2006, at her home in Hull, Massachusetts, due to an overdose of psychiatric drugs. The drugs — Depakote (divalproex; Abbott), Seroquel (quetiapine; AstraZeneca), and clonazepam — were prescribed by Tufts psychiatrist Kayoko Kifuji for the child’s bipolar disorder, which was diagnosed at the age of 2 years.</blockquote>This covers the death of a child, a child, using the above ghost written drug information. Bayer's Use of Social Media to Market Drugs Pharma does adjust to the times and market, if it is not explicitly forbidden then it is fair game. Per a <a href="http://www.pharmalot.com/2011/07/bayer-is-scolded-for-tweeting-new-medicines/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+Pharmalot+%28Pharmalot%29">post</a> in Pharmalot entitled, "To Tweet or not to Tweet" <blockquote>'To Tweet or not to Tweet?' That is a question that Bayer Healthcare will be pondering for some time. The drugmaker was upbraided by the UK’s Prescription Medicines Code of Practice Authority for recently Tweeting about two medicines, which was deemed to be a cause for concern since the information went directly to the public.</blockquote> Much like shooting a gun into a crowd and then claiming they had no way of knowing they would injure someone, a tweet is sent with the full knowledge the first thing everybody will do is hit the forward to all button. Pharma's Public Relations People Infiltrate Patient Support Groups Per a <a href="http://www.healthnewsreview.org/blog/2011/07/creepy-invasion-of-pharma-into-patient-targeted-social-media-space.html">post</a> on the HealthReviewNews Blog we have one of the most frightening posts possible since it shows pharma following individuals and a willingness to intrude into their personal lives. Marilyn Mann is approached on her Facebook page set up to support parents of children with lipid disorders by a drug PR person to promote a drug. <blockquote>Hi Marilyn, A few months ago, I had emailed you about some research I was doing about a new treatment for FH. I am now working with a pharmaceutical company, and the company currently has a drug in development to help treat people with severe FH that may not be responding to current therapies.</blockquote> In the comment section we find this: <blockquote>I'm a communications consultant to many big pharma firms and I'm not sure the PR person in this case did anything wrong. She was upfront and polite about her role, and asked if any patients would do what many have done, and be interviewed to raise the profile of FH. The owner of the group politely declined as was her right. It would have been a different case if there had been any subterfuge involved, but there wasn't. I think on this occasion you have aimed at the wrong target. Good luck with future postings.</blockquote> What do all of these references have in common? Senior executives, and health care academics, removed from the day to day work of helping people being able to claim they are not responsible while making ever larger incomes. Natrecor Shown Not to Work The corporate culture of medicine has become so perverse that even selling a drug that has no benefit becomes acceptable. Per this <a href="http://www.everydayhealth.com/heart-health/0707/study-finds-heart-failure-drug-ineffective.aspx?xid=aol_eh-cardio_24-_20110704&aolcat=ESR&icid=main%7Chtmlws-main-n%7Cdl6%7Csec3_lnk3%7C218187">item</a> in the Heart Health Center Health Day News: <blockquote>Study Finds Heart Failure Drug Ineffective Billions wasted on Natrecor in decade it took to find out it doesn't work, expert says. By Steven Reinberg, HealthDay News WEDNESDAY, July 6 (HealthDay News) — The heart failure drug Natrecor (nesiritide) is ineffective and linked to increased rates of potentially dangerous low blood pressure, a new study finds.</blockquote> Summary: The Most Dangerous Game So, back to my original question: Has medicine become dysfunctional or dangerous? I would contend dangerous. There is nothing magical about the above listed articles or posts. I am not a professional medical person, nor an academic, only someone concerned by the continued decline of medicine and medical care due to a corporate culture that promotes profit above all else. When I meet doctors socially they all speak of being small businessmen. Time and time again we see hospital administrators of all types speaking about being the CEO’s of multi-billion dollar organizations. Drug companies speak of blockbuster drugs as being those with sales of over one billion dollars and fines become the cost of doing business. Today we have a small, but vocal group of people who feel all drugs should be offered to the public and it is up to them to decide if they are appropriate. They also want the government and insurance companies to pay for this return to the pre-FDA days. How will the FDA itself withstand the onslaught of new technologies given out current Federal budget concerns? Tweets and Facebook represent only the beginning of a whole new wave of ways to communicate. My personal opinion is this is a very dangerous time for doctors and patients. Doctors are being pushed into corporate practices where financial gain is the main driver, not health care. Information given to doctors can be so tainted by commercial interest as to be of no value. Patients have no way of knowing where the doctor’s loyalty lies, with them or the practice? DTC ads are full of half truths and fear mongering. Patients need to bring even more information and skepticism to the doctor/patient relationship. I fear we do live in dangerous times. The word “good” has left much of medicine. Steven Lucas MBA

Guest Blog: Health Care in Dangerous Times

Health Care Renewal presents another guest blog by Steve Lucas, a retired businessman who formerly worked in real estate and construction who has a long standing interest in business ethics, and has l…

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08 Jul 2011

Key Opinion Leader Services Companies: the Creation of Useful Idiots and Usefully Idiotic Organizations

In researching the conflicts of interest of the University of California "36," I <a href="http://hcrenewal.blogspot.com/2011/01/why-would-directors-of-health-care.html">stumbled upon</a> a fascinating corner of the pharmaceutical/ biotechnology/ medical device marketing universe, the companies that find and manage<a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders"> key opinion leaders</a> (KOLs), also known as "thought leaders."  Reviewing their own marketing materials reveals how KOLs truly are health care corporate marketing's useful idiots. I found three companies which seem entirely devoted to the adoption, care and feeding of KOLs, plus numerous companies, including some medical education and communication companies (MECCs) that provide KOL-related products and services.  I will first describe the companies briefly, then draw upon their marketing materials to underline what KOLs are really about. Leadership in Medicine Inc This is the company I <a href="http://hcrenewal.blogspot.com/2011/01/why-would-directors-of-health-care.html">found first</a>, because one of its directors is a member of the UC 36, the group of top university leaders who threatened to sue the university to increase their already generous pensions. Leadership in Medicine Inc's <a href="http://www.leadershipinmedicine.com/">web-site </a>describes its reason for being thus: <blockquote>IF YOU NEED TO KNOW who are the most prominent, admired, and influential actors in healthcare, how they are interconnected, and why, you need our expertise. Given how vastly complex are the relationships among providers, researchers, and other significant actors in healthcare, it is vital to focus on key opinion leaders (KOLs) at local, regional, and global levels, and to understand the ties among them. </blockquote> Its <a href="http://www.leadershipinmedicine.com/company.htm">clients</a> are: <blockquote>Over 80 client companies * All of the top 15 largest pharmaceuticals * 8 of the 10 largest biotechs * 5 of the 10 largest medical device companies</blockquote> A graphic on its <a href="http://www.leadershipinmedicine.com/experience.htm">"experience" page </a>listed the following companies: Baxter, Wyeth, Lilly, Roche, Gilead, GlaxoSmithKline, Pfizer, Abbott Laboratories, Genzyme, Bristol-Myers-Squibb, Medtronic, Johnson and Johnson, Genentech, and Covidien. KOL LLC <a href="http://www.kolonline.com/">Company description</a>: <blockquote>As our name implies, we are a company devoted to providing Key Opinion Leader software and Key Opinion Leader Management services for pharmaceutical, biotechnology and device companies. </blockquote> The company's <a href="http://www.kolonline.com/about-clients.asp">graphic client list </a>included: Cephalon, Scios, Novartis, Schering-Plough King Pharmaceuticals, Pfizer, Genentech, Reliant Pharmaceuticals, McNeil (division of Johnson and Johnson, Jazz Pharmaceuticals, Endo Pharmaceuticals, Cytogen, Health Products Research, Shire, Reckitt Benckiser, Protein Design Labs, and Odyssey Pharmaceuticals. Thought Leader Select The relevant parts of the <a href="http://www.thoughtleaderselect.com/about/">company description</a>: <blockquote>Thought Leader Select is a Chapel Hill, NC-based private research and consulting firm serving the biopharmaceutical and healthcare industries.</blockquote>and <blockquote>We serve these industries and the medical community at large by assessing medical experts (known as 'thought leaders' and 'key opinion leaders')....</blockquote> Perusal of the materials used by these companies, and other companies which market KOL or thought leader related services makes the nature of the relationship between KOLs and commercial health care firms, and the purpose of employing KOLs clear. KOLs are Employed by Marketing Departments to do Marketing The best example comes from a description of a KOL information technology application sold <a href="http://www.nagarro.com/Documents/Nagarro_Casestudy_KOL.pdf">by Nagarro</a>: <blockquote>A web-based application was developed by Nagarro to help the marketing department of a global pharmaceutical company exploit Key Opinion Leader (KOL) information in order to promote products and remain ahead of its competition. Problem Description In today s fast-paced competitive environment, pharmaceutical companies cannot solely rely on superior products to succeed. Well organized marketing departments help sales departments reach goals and give companies an edge over competition, but without access to valuable resources, like KOLs, they are ineffective. KOLs influence the medical community and ultimately the end users of pharmaceutical products.</blockquote><blockquote>Pharmaceutical companies that are able to identify and work with KOLs will be better positioned to compete.... Benefits [include] Creation of market intelligence from highly specialized and customizable reports containing previously unavailable aggregate data.... Ability to group KOLs by product knowledge and associations in order to better promote products Ability to maximize ROI from KOL related events Enhanced sales and marketing productivity through streamlining of complex multi-source information</blockquote> That makes it crystal clear that marketers use KOLs to market, to sell products. While at times KOLs might actually be used to advise health care corporations about clinical or scientific issues, that is hardly their major point. KOLs are almost always hired to market by marketing departments. In case someone might argue that this is only one example, let us look at materials from the other companies. KOL LLC <a href="http://www.kolonline.com/services-development.asp">described</a> the usefulness of KOLs thus: <blockquote>Everyone recognizes the value of opinion leaders (OL), or thought leaders. While national level OLs may not write many prescriptions they influence thousands of prescribers and hence prescriptions through their research, lectures, publications and their participation on advisory boards, committees, editorial boards, professional societies and guidelines/consensus document development. Regional level OLs are often involved in state societies or legislative initiatives in addition to their speaking and publications. While local level OLs may not publish, they provide advice to local colleagues and may speak at grand rounds. And who are the ‘rising stars’ in your therapeutic area? It is imperative that you know the OLs in your market at a national, regional and local influence level as well as those ‘rising stars’.</blockquote> This is a bit more indirect, but it is clear that the goal is to "influence prescribers" to prescribe, not provide scientific or clinical advice to the company. Leadership in Medicine Inc's materials also continually emphasized the point of KOLs is to influence, for example, they boasted of pioneering analyses "to assess paths of influence in healthcare," developed a particular tool called "Centrality Ranking" to "provide fine-grained ratings of KOLs' influence," and claimed to "have identified, profiled, and mapped the influence of tens of thousands of individual KOLs...." The clear implication is that KOLs' influence is the central consideration, and what else is this influence good for other than to sell products, and perhaps advocate for corporations in general? When KOLs are Involved, Many Activities that Appear to be Educational or Scientific Really Are For Marketing Strikingly, KOL LLC claimed its role in <a href="http://www.kolonline.com/services-guidlines.asp">guideline development</a>: <blockquote>Guidelines produced by national societies are optimal, but often can be a slow, painful and expensive process to develop. KOL, L.L.C. can provide a faster alternative. We have experience convening a panel of experts in a therapeutic area. We serve a project management role to ensure the timelines and deliverables are met. We have access to a medical writing team of 25 healthcare professionals who can write the initial drafts, as our experience tells us it is easier for experts to edit, than to write from scratch.</blockquote> There has been growing realization that <a href="http://hcrenewal.blogspot.com/search/label/guidelines">guidelines</a> may be biased by commercial sponsorship and by the participation by individuals with conflicts of interest. The KOL LLC marketing materials suggest, however, that guidelines have become purpose-built marketing vehicles through the participation of selected KOLs with allegiances to drug, device and biotechnology companies. As an aside, note that guideline-development services includes the participation of a team of <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost-writers</a> who will write the first drafts, a function that naive academics might have thought should be that of clinical and scientific experts. For another example, KOL LLC asserted it could manage <a href="http://www.kolonline.com/services-investigator.asp">"investigator meetings," </a>: <blockquote>We’ll help you better plan to maximize the communication of the trial results through targeted abstracts, posters, publications and lectures.</blockquote>so <blockquote>Due to the time constraints placed on Clinical Research Departments, many times ‘research mills’ are selected as the trial sites. This is fine, but who is going to publish the results and stand up and present the results at national, regional and local meetings. We can provide you advice and counsel about how to involve your KOLs effectively, while maintaining your aggressive timelines.</blockquote> The goal of KOL management here is for the company to control how the research is disseminated. Note also the cynical view of "research mills," which likely refers to <a href="http://hcrenewal.blogspot.com/search/label/contract%20research%20organizations">contract research organizations</a>. Do we really think that CROs are used by commercial firms because they do better research? Key Leading Organizations A bonus from reading through the offerings on KOL management was to discover another related business that has not been subject of polite conversation before. Leadership in Medicine Inc put it this way: <blockquote>Equally essential is recognizing the roles played by key leading organizations (KLOs) such as medical institutions, payers, professional organizations, patient groups, government entities, and journals in structuring KOL activities and relationships, since those are the stages on which KOLs perform. </blockquote> Key Leading Organizations (KLOs) apparently include influential organizations, e.g., academic medical institutions, medical societies, and patient advocacy groups that can be deliberately turned into organizations of useful idiots for marketing purposes. Note that we and others have discussed how <a href="http://hcrenewal.blogspot.com/search/label/institutional%20conflicts%20of%20interest">institutional conflicts of interest</a> and <a href="http://hcrenewal.blogspot.com/search/label/conflicts%20of%20interest">conflicts of interest</a> affecting leaders of of such organizations can lead to bias in favor of commercial interests. But what Leadership in Medicine Inc has written suggests that such organizations can be deliberately taken over to function as industry's fellow travelers. Similarly, Thought Leader Select advertised services to manage organizations to support "thought leadership": <blockquote>Through Centers, all of our research and assessment skills culminate in our evaluation of universities, influential clinics, and research foundations for a holistic approach to thought leadership in the medical community. With centers of excellence assessments we take a drill-down approach, starting at the academic medical centers, then moving into affiliated hospitals and clinics....</blockquote> Summary Industry spokespeople and key opinion leaders tout themselves as clinical, educational, and/or scientific experts chosen for their expertise to advance medicine, science and public health.  There are documented instances (e.g., see posts <a href="http://hcrenewal.blogspot.com/2008/06/key-opinion-leaders-were-sales-people.html">here</a> and <a href="http://hcrenewal.blogspot.com/2010/10/not-best-and-brightest-drug-marketers.html">here</a>) in which defectors from marketing departments of commercial health care corporations described KOLs as salespeople who could be more influential hidden within their professional or academic cloaks.  Even some physicians paid to be speakers on behalf of pharmaceutical corporations have acknowledged their role as salespeople in fancy dress (see post <a href="http://hcrenewal.blogspot.com/2010/11/of-drug-talks-deception-and-denial.html">here</a>).  There are cases of documents revealed by discovery in legal actions that show how companies planned organized stealth marketing efforts for drugs that included activities by KOLs (e.g., see post <a href="http://hcrenewal.blogspot.com/2009/09/lexapro-marketing-plan-was-meant-to.html">here</a> about marketing of Lexapro, and <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a> about Neurontin). However, the marketing materials used by KOL service companies (for lack of a better name) show that KOLs are largely meant to be stealth marketers, and hired for that purpose, that KOLs participate as marketers in the sorts of activities that to the naive appear to be educational or scientific, and that marketers try to recruit whole organizations, such as medical schools, research organizations, medical societies, and patient advocacy groups as disguised sales organizations. This goes beyond the problem of bias of physicians, or individual health professionals due to their financial relationships.  It goes beyond the problem of bias of organizations due to their sources of financial support or the financial relationships of their leaders.  It looks like there has been a massive campaign by health care corporate marketers to make useful idiots out of possibly a majority of medical academics and academic, professional, and supposedly patient-centered organizations.  This appears to be a massive, cynical effort to hollow out our once respected health care institutions and professionals in the service of marketing. A final word to any individuals reading this who are paid by corporate marketers to be KOLs.  If you think that you are paid for educational or scientific purposes, you likely have been made into a chump.  The people who did this to you were likely not acting in your best interests, or those of society, but to cynically market their product and increase their own earnings.  If you doubt this, look at the materials cited above.  You really don't want to continue being chumps, do you?

Key Opinion Leader Services Companies: the Creation of Useful Idiots and Usefully Idiotic Organizations

In researching the conflicts of interest of the University of California "36," I stumbled upon a fascinating corner of the pharmaceutical/ biotechnology/ medical device marketing universe, the compani…

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07 Jan 2011

BLOGSCAN - This Book is Haunted

We have posted quite a bit about ghost-written articles, that is, ostensibly scholarly articles appearing in medical and health care journals with apparently prominent authors that were really written mainly by medical writers hired by companies to market particular products, usually drugs.  Now we hear of a case of a ghost-written book.  Our fellow bloggers have covered this well.  See posts <a href="http://www.margaretsoltan.com/?p=27749">here</a> and <a href="http://www.margaretsoltan.com/?p=27756">here</a> by Professor Margaret Soltan in University Diaries, and<a href="http://www.insidehighered.com/blogs/university_diaries/to_be_removed_before_submission"> here</a> on Inside Higher Ed; <a href="http://carlatpsychiatry.blogspot.com/2010/11/its-textbook-its-ad-its.html">here </a>by Dr Daniel Carlat on the Carlat Psychiatry Blog; <a href="http://brodyhooked.blogspot.com/2010/11/ghostwriting-from-journal-articles-to.html">here</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog; and <a href="http://alison-bass.blogspot.com/2010/12/government-oversight-agency-calls-on.html">here</a> by Alison Bass on the Alison Bass blog.  Ghost writing is often an important component of stealth marketing schemes, and serves not only to deceptively market products, but to deceptively increase the influence and prestige of the "key opinion leaders" who enable the practice.  Be skeptical about the medical literature, and particularly skeptical by any academic who seems to have written more articles than would be humanly possible. ADDENDUM (2 December, 2010) - As suggested by the comment below, see also posts <a href="http://1boringoldman.com/index.php/2010/11/30/a-quintessential-resource/">here</a> and  <a href="http://1boringoldman.com/index.php/2010/12/01/roaches/">here</a> on the 1BoringOld Man blog.  Also see an additional <a href="http://brodyhooked.blogspot.com/2010/12/more-on-recent-ghostwriting-allegations.html">post</a> by Dr Howard Brody on the Hooked: Ethics, Medicine and Pharma blog.

BLOGSCAN - This Book is Haunted

We have posted quite a bit about ghost-written articles, that is, ostensibly scholarly articles appearing in medical and health care journals with apparently prominent authors that were really written…

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01 Dec 2010

Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory drug Vioxx have provided grist for the <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> mill since 2005.  For example, see these posts: - <a href="http://hcrenewal.blogspot.com/2005/04/more-evidence-of-ghostwriting.html">here</a> about ghost-writing of a Vioxx research publication; - <a href="http://hcrenewal.blogspot.com/2005/06/allegations-that-merck-threatened.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2005/12/more-allegations-that-merck-executives.html">here</a> about allegations that Merck executives tried to intimidate Vioxx critics; - <a href="http://hcrenewal.blogspot.com/2007/03/drug-crazy.html">here </a>about how advocates of an extreme laissez faire approach to regulation of health care corporations used illogical arguments about the Vioxx case; - <a href="http://hcrenewal.blogspot.com/2008/08/article-in-annals-of-internal-medicine.html">here</a> about how an apparently major clinical trial of Vioxx turned out to be a "seeding trial," that is, a study really meant to recruit supposed physician-researchers as prescribers; and - <a href="http://hcrenewal.blogspot.com/2010/01/physician-pleads-guilty-to-fraud-for.html">here</a> about how one once prominent Vioxx researcher pleaded guilty to fraud in connection with his research on other drugs.  Thus, the Vioxx case provides a good lesson about some of the tactics used to deceptively and unethically promote health care products (pharmaceuticals in this case). Merck just announced just the latest settlement of Vioxx related legal actions, as <a href="http://www.businessweek.com/news/2010-02-10/merck-changes-safety-procedures-pays-in-vioxx-suits-update1-.html">reported by Business Week</a>: <blockquote>Merck & Co. agreed to settle shareholder lawsuits over the withdrawn Vioxx painkiller by strengthening its drug-safety procedures, appointing a new chief medical officer and paying $12.2 million in legal fees. Merck would appoint one committee to address risks that require immediate action and another to monitor the safety of drugs, the company said in a regulatory filing. Merck would also amend its code of conduct to promote scientific and academic integrity as well 'honest communication' with doctors. 'In all research endeavors that are sponsored by Merck, we will refrain from attempting to influence inappropriately the results and conclusions of such research,' according to the amended code. 'We strive for all communications with the medical community to be accurate, truthful and consistent with labeling.'</blockquote> Also, <blockquote>The company will be required to make corporate governance changes and “supplement existing policies and procedures,” ... [a Merck spokesperson] said.</blockquote><blockquote>Merck would submit results of clinical trials to a public registry, with its compliance overseen by an independent third party. The chief medical officer will have an 'executive voice' on product safety issues independent of Merck Research Laboratories. </blockquote>Note that this settlement is only of one type of lawsuit, as described in <a href="http://online.wsj.com/article/SB10001424052748704140104575057231552987908.html">a Wall Street Journal article</a>, <blockquote>The pact, which is pending final court approval, would resolve state and federal shareholder 'derivative' complaints (which are brought by shareholders on behalf of a company) alleging that current and former Merck officers and directors breached their fiduciary duties in handling Vioxx. </blockquote>Merck had already settled thousands of lawsuits, <blockquote>Since the Vioxx controversy erupted, about 27,000 personal-injury lawsuits have been filed, the company says. Merck has been challenging all of the cases and settled many of them. Most notably, it agreed to a pay $4.85 billion to settle personal-injury claims of more than 40,000 people. In another settlement, the company will pay $80 million to resolve 190 claims filed by drug-benefit plans seeking to recover costs of paying for Vioxx use.</blockquote>Merck has lots of other legal actions to go through, <blockquote>The Vioxx litigation remains far from over. The U.S. Supreme Court is weighing a separate shareholder case, seeking billions of dollars in damages from the company. Merck disclosed last year the U.S. Attorney's office in Boston was conducting a grand-jury investigation of Merck's handling of Vioxx. The claims of some 310 plaintiff groups are outstanding in courts in the U.S., according to the securities filing. There are also cases overseas, including Australia and Turkey.</blockquote>So the parade of legal actions and settlements thereof continues.  We believe that the scope of <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">this parade</a> provides some sort of index of bad behavior by the health care organizations needing to make such settlements.  Most of these legal results are reported on in the business media, and rarely appear in any medical, health care research, or health policy journals.  I submit that were health care professionals, health care researchers, and health policy makers more systematically aware of these cases, they might realize that unethical and sometimes illegal behavior, often generated by bad leadership unrestrained by poor organizational governance, is a major cause of the current, seemingly intractable health care crisis. One notable attribute of the current Vioxx settlement is that it does mandate some changes in Merck's governance and leadership meant to prevent future cases similar to this one.  These include developing leadership structures and changing the company's code of conduct to emphasize the need for "truthful" communication, and the need to refrain from "inappropriately" influencing research.  On <a href="http://hcrenewal.blogspot.com/">Health Care Renewal</a> we have discussed numerous examples of deceptive practices by health care organizations, often affecting marketing, and of <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> of research.  It is a small step forward for one company to commit to honest communications and to not manipulate research.  A better code of conduct may at least be a start towards an <a href="http://hcrenewal.blogspot.com/2009/10/organisational-ethics-policies-primer.html">organizational ethics policy</a>, which in turn may have the potential to actually improve behavior.  On the other hand, typical settlements that involve only monetary damages paid by the organization seem to have little deterrent effect on future bad behavior. Usually, the companies involved only need to pay fines, and no individual who performed, directed or approved unethical or illegal acts suffers any negative consequences. I submit once again that such fines are viewed merely as costs of doing business by the affected companies, and do not deter future bad behavior. Until the people who approve, direct, and perform unethical or illegal acts pay some penalties, expect such acts to continue, at best deterred only slightly by written policies that condemn them. I again suggest that to truly reform health care, we need rigorous regulation of health care organizations that has the power to deter unethical behavior that may risk patients' health

Merck Settles Another Vioxx Case

All the shenanigans that went on in the course of Merck's marketing of the now withdrawn Cox-2 inhibitor non-steroidal anti-inflammatory drug Vioxx have provided grist for the Health Care Renewal mill…

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11 Feb 2010

British Medical Journal Interviews Dr Aubrey Blumsohn

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest.  Our most recent summary of the case was <a href="http://hcrenewal.blogspot.com/2009/09/reappearance-of-ghost-of-seasons-past.html">here</a>.  The case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research. The case was just re-capped in some detail on the occaision of an interview of Dr Blumsohn published in the British Medical Journal, just available on-line yesterday.  [Cyer C. Aubrey Blumsohn: academic who took on industry.  Brit Med J 2009; 339:b5293.  Link <a href="http://www.bmj.com/cgi/content/full/339/dec15_1/b5293">here</a>.]  Dr Blumsohn's final words in the interview were: <blockquote>It’s hard to encourage anyone to speak out about poor practice in the current environment. This case sums up what has gone wrong with systems set in place to ensure safety and integrity in scientific medicine. It would help if regulators put as much effort into responding to serious critics and whistleblowers as they do producing glossy brochures and yet more guidance. </blockquote> My hat is off to Dr Blumsohn for his determination to pursue this case, and to the British Medical Journal for getting it into the "main-stream" health care literature. Hat-tip to <a href="http://pharmagossip.blogspot.com/2009/12/dr-aubrey-blumsohn-pharmagossips-person.html">PharmaGossip</a>.

British Medical Journal Interviews Dr Aubrey Blumsohn

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16 Dec 2009

How Industry Views the Research It Sponsors

We have posted frequently about threats to the integrity of the clinical evidence-based, and to the practice of evidence-based medicine.  In particular, we have discussed how research may be <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> in favor of vested interests, or <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a> when the results do not favor such interests. Last week, the British Medical Journal electronically published a set of guidelines for how industry sponsored clinical research ought to be published, sponsored by the International Society for Medical Publication Professionals.  The authors came from pharmaceutical companies (Johnson & Johnson, AstraZeneca, Pfizer and Cephalon), medical device companies (LifeScan), and medical publishing and medical education and communication companies (John Wiley & Sons, Excerpta Medica, Field Advantage Medical Communications, PharmaWrite, and Knowledgepoint 360 Group).  [Graf C, Battisti WP, Bruce-Winkler V et al. Good publication practice for communicating company sponsored medical research: the GPP2 guidelines.  Brit Med J 2009; 339:b4430.  Link <a href="http://www.bmj.com/cgi/content/full/339/nov27_1/b4330">here</a>.] These guidelines are remarkable for the questions they raise about how people from industry view clinical research and how it should be reported in medical journals.  Who's in Charge? Nowhere does the article acknowledge that any one person has overall responsibility for a research project.  Clinical research projects funded by the US National Institutes of Health, Agency for Healthcare Quality and Research, and other federal agencies must have "principal investigators," who are the people who take overall scientific responsibility for the project.  The Graf et al article does not use this or an equivalent term.   There is no sense that they expect anyone to be in completely in charge of industry sponsored research.  Particularly confusing is the following passage: <blockquote>Before writing begins one author (a lead author, who may also be guarantor) should take the lead for writing and managing each publication or presentation. One author (identified as guarantor) should take overall responsibility for the integrity of a study and its report. </blockquote> Here are some questions it raises.  If the guarantor could be chosen only when writing a paper is contemplated, which presumably could be years after the study that the paper would report was designed and implemented, who then would have been responsible for study "integrity" before the guarantor was chosen? Who would chose the guarantor for a particular paper? If a study generates more than one paper, could they each have a guarantor, and then how could they share responsibility for study "integrity?"  If the guarantor and lead author of a paper are different people, how would they share responsibilities, what would happen if they were not to agree, and who would be finally accountable? So the guidelines seem to completely diffuse accountability for research projects, and the reports written about them. Who is an Author? In my experience with US federally and foundation funded research, research papers are written by the investigators, the people who actually did the research project.  However, in the guidelines by Graf et al, the concept of authorship is also ambiguous.  They suggest that "recognised criteria should be used to determine which of the contributors to an article should be identified as authors."  This is already confusing, since how could one be a "contributor" to an article without authoring it?  A later discussion of "contributors" as "investigators, sponsor employees, and individuals contracted by the sponsor" was not very helpful.  Why should a "sponsor employee" who was not an "investigator" be a "contributor" or an "author," whatever the distinction is between them?  So the guidelines blur distinctions among people who do research, and people employed by companies that may have vested interests in the research favoring their products or services. What do Professional Medical Writers Do? There has been considerable recent controversy, not directly acknowledged by Graf et al, about the role of professional medical writers in the reporting of research and the writing of ostensibly scholarly medical publications, particularly in cases where the writers were paid by and reported to corporate sponsors, but were not recognized as such in the publications they wrote (a type of <a href="http://hcrenewal.blogspot.com/search/label/ghost%20writing">ghost-writing</a>).  The guidelines by Graf et al do not clearly explain what the roles of professional medical writers ought to be: <blockquote>Professional medical writers must be directed by the lead author from the earliest possible stage (for example, when the outline is written), and all authors must be aware of the medical writer’s involvement. The medical writer should remain in frequent contact with the authors throughout development of the article or presentation. The authors must critically review and comment on the outline and drafts, approve the final version of the article or presentation before it is submitted to the journal or congress, approve changes made during the peer review process, and approve the final version before it is published or accepted for presentation. </blockquote> Note that this would not prevent a professional medical writer from writing an initial outline, the first draft, and all subsequent drafts. including the final draft of a paper. (The role of an "author" above might be restricted to simply commenting on and accepting the outline and all drafts.) Thus, the "authors" could function as distant editors, and the professional writer would assume authorship, as most people would define it. (Merriam-Webster: "1. one that originates or creates 2. the writer of a literary work.") Furthermore, while the professional writer could take one the role of authorship, the guidelines do not require him or her to publicly acknowledge this role: <blockquote>Professional medical writers, depending on the contributions they make, may qualify for authorship. For example, if a medical writer contributed extensive literature searches and summarised the literature discovered, and by doing so helped define the scope of a review article, and if he or she is willing to 'take public responsibility for relevant portions of the content' then he or she may be in a position to meet the remaining ICMJE criteria for authorship. </blockquote> Presumably, a professional writer could dodge authorship by simply being "unwilling" to take such public responsibility. So the guidelines apparently condone nearly all functions commonly assumed to be those of an author to be performed by a professional writer paid directly by the sponsor, without the writer being listed as an author.  The guidelines thus appear to condone ghost-writing in its most pernicious form. Who Owns and Analyzes the Data? Cases in which various the implementation and analysis of clinical research seems to have been <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> to favor vested interests have raised concerns about the integrity of the data collected in the course of a research project, and how it is analyzed.  This is what Graf et al say about the ownership and use of the data: <blockquote>Sponsors have a responsibility to share the data and the analyses with the investigators who participated in the study. Sponsors must provide authors and other contributors (for example, members of a publication steering committee or professional medical writers) with full access to study data and should do so before the manuscript writing process begins or before the first external presentation of the data. Information provided to the authors should include study protocols, statistical analysis plans, statistical reports, data tables, clinical study reports, and results intended for posting on clinical trial results websites. Sufficient time should be allowed for authors and contributors to review and interpret the data provided and to seek further information if they wish (for example, access to raw data tables or the study database). </blockquote> The guidelines by Graf et al suggest that the company that sponsors the research should own the data. The investigators who collected the data and implemented the research project should not. At best, the company should "share" summaries, analyses, or pieces of the data, but at best investigators could have only "sufficient time" to "seek ... access to raw data tables or the study database." So the guidelines would allow corporate research sponsors to analyze the data from studies evaluating their own products and services as they see fit, and the scientists who implemented the study and collected the data could only ask for access to it.  Summary The guidelines by Graf et al seem based on a very strange conceptualization of clinical research. In their view, no individual may be responsible for a clinical research project. Research data is controlled by the company that paid for the project, not scientists who implemented the research and collected the data. Research papers may be written by anonymous professional writers while the scientists who did the research only need to review and approve what they have written. So why should anyone give credence to industry sponsored research? We have discussed numerous instances in which clinical research was <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulated</a> in favor of vested interests, and when clinical research whose results did not favor vested interests was <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppressed</a>. In most cases, the vested interests were held by for-profit pharmaceutical, biotechnology or device anufacturers acting as research sponsors. The guidelines by Graf et al seem to have been cleverly written to to employ comforting platitudes while licensing manipulation and suppression.  They should inspire no confidence in the integrity of industry sponsored research.

How Industry Views the Research It Sponsors

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30 Nov 2009

GHOSTING MATILDA

The fall season is upon us and the markets are filled with advertising for Halloween, so our thoughts naturally turn to the recent stories of ghostwriting in medical journals. Here is a lighthearted take on that topic. This parody began on <a href="http://www.margaretsoltan.com/?p=17582">Margaret Soltan’s blog</a> a few days ago, and it has just kept growing. GHOSTING MATILDA Once a jolly bagman signed on to some articles. Corporate ghosts even promised him a fee. And he sang as he watched and waited till they were in print, These will be grand right up there on my CV. Ghosting Matilda, ghosting Matilda, Who’ll come a-ghosting Matilda with me? And he sang as he watched and waited till they were in print, These will be grand right up there on my CV. This month it’s Janssen, next it’s Bristol-Myers Squibb. Wyeth and Lilly soon might want to talk to me. Novartis might sign me up, also AstraZeneca ─ Soon I’ll be famous like that guy at Emory. Ghosting Matilda, ghosting Matilda, Who’ll come a-ghosting Matilda with me? Novartis might sign me up, also AstraZeneca ─ Soon I’ll be famous like that guy at Emory. Up came an editor, looking for the telltale signs. Ghost writing’s hard to cover up, you see. And he found them in the documents: metadata do not lie ─ Bagman just sold his name and passed these off on me. Ghosting Matilda, ghosting Matilda, Who’ll come a-ghosting Matilda with me? And he found them in the documents: metadata do not lie ─ Bagman just sold his name and passed these off on me. Up jumped the bagman, pointing fingers right and left, You’ll never prove that I lied, said he. I will say that underlings failed to send disclosure forms; Let them be blamed instead, while I get off scot-free. Ghosting Matilda, ghosting Matilda, Who’ll come a-ghosting Matilda with me? I will say that underlings failed to send disclosure forms; Let them be blamed instead, while I get off scot-free. Out! said the editor, you’re now persona non grata. So, too, the Dean and the Provost agreed. Bagman’s ghost may be heard now, sighing in the library ─ Could have been grand right up there on my CV. Ghosting Matilda, ghosting Matilda, Who’ll come a-ghosting Matilda with me? Bagman’s ghost may be heard now, sighing in the library ─ Could have been grand right up there on my CV.

GHOSTING MATILDA

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25 Sep 2009

The Reappearance of a Ghost of Seasons Past

About a year after we started Health Care Renewal, in late 2005, we wrote multiple posts about the complex and unfortunate case of Dr Aubrey Blumsohn's attempts to keep a research project honest. The early posts were <a href="http://hcrenewal.blogspot.com/2005/12/another-challenge-to-integrity-of.html">here</a>, <a href="http://hcrenewal.blogspot.com/2005/12/more-on-blumsohn-procter-gamble.html">here</a>, <a href="http://hcrenewal.blogspot.com/2005/12/no-protection-for-whistle-blowers.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2005/12/paying-for-silence-updating-blumsohn.html">here</a>. In <a href="http://hcrenewal.blogspot.com/2005/12/more-summary-and-much-documentation-of.html">this post</a>, we summarized the case thus: <ul><li>Dr Aubrey Blumsohn, a senior lecturer at Sheffield University, and Professor Richard Eastell performed a research project on the effects of the drug risedronate (<a href="http://www.actonel.com/index.jsp">Actonel</a>, made by Procter & Gamble Pharmaceuticals [P&G]) under a <a href="http://www.fraudinscience.org/PG/contract.pdf">contract</a> between P&G and the University.</li><li>Although the research contract designated Blumsohn and Eastell as "Investigators" under whose direction the project would be carried out, Blumsohn was not given access to the original data collected by the project.</li><li>Despite numerous requests, (like <a href="http://www.fraudinscience.org/PG/20050525mckay.pdf">this one</a>), P&G <a href="http://www.fraudinscience.org/PG/20030619email.htm">refused access </a>to this data <a href="http://www.fraudinscience.org/PG/attorneyreq.pdf">repeatedly</a>. Blumsohn was concerned that he and Eastell could be accused of scientific fraud if they continued to make presentations and write articles and abstracts without access to the data which they were supposedly writing about.</li><li>Blumsohn became suspicious that some of the analyses done by P&G could be misleading, especially <a href="http://www.fraudinscience.org/PG/20030909audio.htm">related to a graph shown to him that omitted 40% of patient data</a>.</li><li>Blumsohn objected to <a href="http://www.fraudinscience.org/PG/20030424email.htm">P&G arranging for papers and abstracts to be written by a professional writer</a>, but with Blumsohn listed as first author. Blumsohn was concerned that such ghost-written documents were mainly meant to convey "key messages" in support of P&G's commercial interests.</li><li><a href="http://www.fraudinscience.org/PG/20030910audio.htm">Eastell warned Blumsohn </a>not to aggravate P&G, because the company was providing a grant to the University which "is a good source of income."</li><li>After repeated failed attempt to get the data, Blumsohn complained to numerous officials at Sheffield University, including <a href="http://www.fraudinscience.org/PG/20040526eastell.pdf">Eastell</a>, medical school Dean <a href="http://www.fraudinscience.org/PG/20050708weetman.pdf">Tony Weetman</a>, University Vice-Chancellor <a href="http://www.fraudinscience.org/PG/20050814bouche.pdf">Robert Boucher</a>, and the Head of the University's Department of Human Resources, <a href="http://www.fraudinscience.org/PG/20050627boucha.pdf">Ms R Valerio</a>.</li><li>Still unable to get the data, he spoke with news reporters about his case. At this point, Sheffield suspended him, but then <a href="http://www.fraudinscience.org/PG/gag.doc">offered him a severance agreement </a>if he signed a contract binding him not to make any detrimental or derogatory statements about the University and its leaders.</li></ul>So the case involved suppression and manipulation of research, ghost-writing, institutional conflicts of interest, and attempts to silence a whistle blower. It provides lessons about the downsides of letting commercial firms sponsor and hence control human research designed to evaluate the products or services they sell; and of academic medicine becoming dependent on research money from such firms for such research. Although Health Care Renewal, being US based, most often writes about such issues in the US, this case is a reminder that they are global. (Note that we posted more about this case in 2006, <a href="http://hcrenewal.blogspot.com/2006/01/more-fall-out-from-blumsohn-procter.html">here</a>, <a href="http://hcrenewal.blogspot.com/2006/02/blumsohn-tours-washington-to-raise.html">here</a> and <a href="http://hcrenewal.blogspot.com/2006/05/dr-aubrey-blumsohn-on-north-american.html">here</a>, but since then it has not gotten much public attention.)Last weekend the (UK) Guardian <a href="http://www.guardian.co.uk/science/2009/sep/18/doctors-ghost-writing-pharmaceutical-research">returned</a> to it: <blockquote>The Guardian has learned that one of Britain's leading bone specialists is facing disciplinary action over accusations that he was involved in 'ghost writing'. The General Medical Council will call Professor Richard Eastell in front of a fitness to practice committee. Eastell, a bone expert at Sheffield University, has admitted he allowed his name to go forward as first author of a study on an osteoporosis drug even though he did not have access to all the data on which the study's conclusions were based. An employee of Proctor and Gamble, the US company making Actonel, was the only author who had all the figures. Experts believe the practice is widespread in Britain. In a letter published in the Journal of Bone and Mineral Research, which carried the original study, he stated: 'In the original paper one of the authors, a statistician working for P&G, Ian Barton, had full access to all the data.' The authors had full access to all the analyses of the data that they requested, he said – but those analyses were carried out by the company. The letter, published in 2007, also acknowledged flaws in the study. A later independent analysis of the data 'identified some errors and poor practice', he wrote. The study was designed to show the strengths of Actonel which was in fierce competition with a rival bone-strengthening drug called Fosamax, made by Merck. Eastell's paper concerned a study carried out on behalf of Proctor and Gamble, comparing the bone density of women prescribed Actonel with others who were not. Only the company knew which women were on the drug and which were taking something else. Eastell's colleague, Dr Aubrey Blumsohn, wanted the codes which would say which of the patients who suffered fractures had been on the drug. The company refused. Blumsohn took his concerns to Eastell, but in a conversation which Blumsohn says he taped , Eastell said he was concerned that persistent requests might damage the relationship they had with the company. Eastell is said to have told him: 'The only thing that we have to watch all the time is our relationship with P&G. Because … we have the big Sheffield Centre Grant [from P&G] which is a good source of income, we have got to really watch it.' . </blockquote> So, after four years, this case has generated an official hearing of sorts. The hearing is obviously late, and seemingly will only be devoted to only one aspect of this case (ghost writing). However, at least our friends in the UK are doing something. I cannot recall a single case that resulted in any serious consideration of imposing negative consequences on anyone who was accused of suppressing research, manipulating research, endorsing ghost-writing, or intimidating a whistle-blower. In fact, many of the more troubling cases have never resulted in any sort of public discussion either at the institutions at which they occurred, or at any organization with relevant regulatory, or even just moral authority. So the GMC hearing is at least a step forward. Two cheers for the British GMC, and none for US universities, academic medical centers, professional societies, and government regulators. (If anyone can remind me of a case in which there was a public discussion at the relevant institution, or some public consideration of the case by a regulatory agency, professional society, or some group with moral authority, please remind me of it, and I would be happy to post about it.)

The Reappearance of a Ghost of Seasons Past

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25 Sep 2009

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