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Shareholders Take Notice That Patients Used As Unconsented Guinea Pigs, Physicians as Bank by Health IT Vendors

At my Jan. 2009 post "<a href="http://hcrenewal.blogspot.com/2009/01/wsj-waste-feared-in-digitizing-patient.html">Waste Feared in Digitizing Patient Records: Wall Street Journal</a>" and others I have written about the illegitimacy of the abuse of patient rights, as well as abuse of clinician trust committed by health IT vendors using patient care settings as an unconsented software development laboratory and beta testing site. I wrote: <blockquote>The IT industry uses hospitals, doctor offices and patients as alpha and beta test sites and subjects, unregulated by the FDA or other agency. When HIT fails, there is no central agency to report the failures to, only the vendor. Fixes go into a "queue" for remediation, with priority level decided by the vendor.</blockquote> Clinicians are also used by HIT vendors as a form of bank and insurance company. HIT vendors depend on (free!) physician and nurse ingenuity in finding workarounds to the ill-conceived design and user experience (<a href="http://tinyurl.com/hostileuserexper">link</a> to my eight part series on this issue) that their products usually present so that their products can even be salable. This, of course, taxes and tires clinicians at the expense of patients and hampers and complicates EHR diffusion. Clinicians become, in effect, unpaid development consultants to HIT companies (or, perhaps more accurately, since EHR's do become essential to medical practice, indentured servants to the HIT vendors). Also, under the unethical, Joint Commission-violating and executive fiduciary responsibility-violating "Hold Harmless" and "Defects Nondisclosure" HIT contracting clauses, clinicians pay the price for bad patient outcomes, even if the causative factor was HIT errors. (See <a href="http://www.hcrenewal.blogspot.com/2009/03/health-it-hold-harmless-and-defects-gag.html">Health IT Hold Harmless and Defects Gag Clauses: Have Hospital Executives Violated Their Fiduciary Responsibilities By Signing Such Contracts?</a>, and my July 22, 2009 JAMA <a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382">letter to the editor</a> on this issue.) Thus, clinicians become an insurance company, bank and risk safety net (a term that might not be inappropriate is "suckers") for the HIT vendors. This is not an optimal way to treat one's ultimate customers. HIT is <a href="http://www.tinyurl.com/hit-misadventure">a mess</a>, but that doesn't stop HIT vendors from simply lying about their financial status and future projected business to the investor community. Now, HIT company shareholders are taking note of these industry (mal)practices. These (mal)practices are hitting shareholders where it really hurts - in the pocketbook. My comments in [red italics]: <blockquote> <a href="http://www.healthcareitnews.com/news/allscripts-shareholders-file-class-action-suit">Allscripts shareholders file class action suit</a> Healthcare IT News August 05, 2009 | Bernie Monegain, Editor CHICAGO – Allscripts shareholders have filed a lawsuit alleging the company broke federal securities laws when it went live with the newest version of its EHR clinical software, Touchworks [i.e., a "version" that had not been thoroughly tested and validated outside hospital walls, a practice HIT vendors get away with due to the near spinelessness of regulators such as the Joint Commission, FDA, and others - ed.] . Allscripts officers say the suit is without merit. [As I pointed out at "<a style="font-style: italic; font-weight: bold;" href="http://hcrenewal.blogspot.com/2008/10/do-healthcare-organizations-truly-want.html">Do Healthcare Organizations Truly Want Electronic Health Records To Succeed?</a>" regarding the lawsuit my own organization filed against this company and its partner Medicomp Systems (civil complaint PDF <a style="font-style: italic; font-weight: bold;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/DUCOM_EMR_Complaint.pdf">here</a>), where incomplete, untested and non-functional software was sold by this company for use by our physicians, I'd say the allegations do deserve further investigation - ed.] "We are aware of the lawsuit and have reviewed the complaint," Allscripts officials said Wednesday. "While it is our policy not to comment on the substance of pending litigation, we believe the lawsuit is without merit and will vigorously defend the allegations." The lawsuit, which seeks class action status, has been filed in the United States District Court for the Northern District of Illinois on behalf of those who purchased the common stock of Allscripts-Misys Healthcare Solutions, Inc. (formerly known as Allscripts Healthcare Solutions, Inc.) between May 8, 2007 and Feb. 13, 2008. It names Allscripts-Misys Healthcare Solutions, CEO Glen Tullman and Chief Financial Officer William J. Davis as defendants. At a user conference in Orlando, Fla., July 30-31, Allscripts CEO Glen Tullman told some of the attendees that Allscripts might have rushed version 11 of Touchworks to market too quickly. ["Might have" rushed it out too quickly? It had, in fact, been delayed several months according to the lawsuit. "Perhaps" the delays needed to be lengthier. In other words, f*** the doctors and patients, we're getting this cr** out the door so as to not further injure our profits with further delays - ed.] He said the company was caught off guard by providers who found new uses for the product. ["New uses?" (We all know that when companies sell broken HIT, it's always the doctors' fault) ... Likely translation: clinicians tried to practice medicine the way they saw best, not the way the Allscripts software designers saw best or "approved of." (Arrogance, anyone?) The clinician users tried to use the software in a real-world setting while applying the improvisations needed for proper patient care in a poorly bounded, uncertain environment (per <a href="http://www.ctlab.org/documents/Hiding%20in%20plain%20sight.pdf">Nemeth and Cook</a>) and found the software's support of the uncertainties and realities of the clinical environment, and likely the software's stability itself, poor - ed.] Tullman and Faisal Mushtaq, the company's senior vice president of product development, said Allscripts has invested roughly $14 million to improve stability and performance [after throwing the doctor and patient test subjects to the wolves after a "might have rushed it out" premature rollout - ed.], and they expect the next version, to be rolled out soon, to work more smoothly. [I really despise the "version 1.1 will be much better" in healthcare settings, as it goes back to the issue of sick patients as unconsenting subjects in a software testing lab, and physicians as a bank and insurance company for the vendors when things go wrong -ed.] The complaint alleges that defendants failed to disclose the following adverse facts: * Allscripts lacked the necessary resources [i.e., smart, a.k.a expensive, people who actually know what they're doing thanks to the appropriate informatics education and expertise. Were the ones they did have tied up in patchwork remediation and crisis management? - ed.] to install V-11 software at customer sites; Allscripts had no historical basis to estimate the completion of V-11 or the impact V-11 sales might have on the company's 2007 revenues and earnings [if they made stuff up, that would not be too uncommon in today's financial environment. Also, the "lack of necessary resources", not unique to Allscripts, portends quite poorly for the planned, manic rush to national EHR by the cavalierly short deadline of 2014 - ed.] * The complexity of V-11 had materially and adversely lengthened the sales cycle and revenue recognition cycle for the company's V-11 sales contracts [Another instantiation of my belief that business IT sales practices are inappropriate for clinical IT, where there are unconsenting "customers" with special rights - patients. One also wonders: did clinicians balk at a Rube Goldberg contraption but hospital executives purchase it anyway? - ed.]; * Allscripts was currently experiencing adverse and continuing delays in the installation of V-11 software systems [which were perhaps not revealed by clients, thanks to secrecy clauses regarding defects and problems as noted by Penn's <a href="http://jama.ama-assn.org/cgi/content/extract/301/12/1276">Koppel and Kreda</a> in JAMA? - ed]; * Based on the foregoing, defendants had no reasonable basis for their statements concerning Allscripts' current and future financial performance and projections. The law firm of Izard Nobel LLP, based in West Hartford, Conn. announced the class action lawsuit on Wednesday. Click here to read the complaint: <a href="http://www.izardnobel.com/allscriptsmisyshealthcare/">http://www.izardnobel.com/allscriptsmisyshealthcare/</a> .</blockquote> The PDF of this class action complaint is <a href="http://www.izardnobel.com/admin/uploads/2453451964a78a212b0bdc.pdf">here</a>. So, it seems entirely possible the defects nondisclosure clauses promulgated by these vendors, and accepted by meek hospital executives and CIO's, may have supported and/or led to a situation of shareholder fraud. It would be ironic indeed if these cavalier HIT practices end, and the HIT vendors began to adhere to principles of responsibility and resilience engineering, not due to regulatory pressures but due to shareholder lawsuits. Finally, Allscripts CEO Tullman was a campaign adviser to the President on healthcare. It's perhaps due to advisers like this that national plans for healthcare reform are sinking like the Titanic. As per my Feb. 18, 2009 <a href="http://hcrenewal.blogspot.com/2009/02/medinformaticsmd-in-wall-street-journal.html">Wall Street Journal letter</a>: <blockquote>... it is the government that has been deceived [rather than the public] by the HIT industry and its pundits. Stated directly, the administration is deluded about the true difficulty of making large-scale health IT work. The beneficiaries will largely be the IT industry and IT management consultants ... The government has bought the IT magic bullet exuberance hook, line and sinker.</blockquote> -- SS addendum: Perhaps I should self-turn in this post as "fishy" to the <a href="http://www.google.com/search?q=healthcare+reform+snitch+line&ie=utf-8&oe=utf-8&aq=t&rls=org.mozilla:en-US:official&client=firefox-a">healthcare reform snitch line</a> at "flag@whitehouse.gov"?

Shareholders Take Notice That Patients Used As Unconsented Guinea Pigs, Physicians as Bank by Health IT Vendors

At my Jan. 2009 post " Waste Feared in Digitizing Patient Records: Wall Street Journal " and others I have written about the illeg...

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Sixth International Congress on Peer Review and Biomedical Publication

I just found out that the program of this year's Sixth International Congress on Peer Review and Biomedical Publication, to be held on September 10-12, 2009, in Vancouver, BC, Canada is likely to be of great interest to Health Care Renewal readers. The conference is held every four years on topics relevant to medical journal editors and reviewers, but previous conferences emphasized topics as impact factors, blinded review, open publishing, etc. This year, however, there will sessions on: <ul><li>Authorship and Contributorship - including 3 of 4 presentations on ghost-writing</li><li>Data Sharing and Conflicts of Interest - including 4 of 5 presentations on conflicts of interest in research</li><li>Publication Bias - including 3 of 3 presentations which appear to discuss research manipulation and suppression </li><li>Rhetoric - including 3 of 3 presentations apparently about how articles reporting original research may exaggerate or distort the results</li></ul>There will also be poster presentations on relevant topics. See <a href="http://www.ama-assn.org/public/peer/preliminary_program.html">this link </a>for further information and registration information. This conference program seems to have a higher concentration of Health Care Renewal relevant topics than any conference of which I am aware to date.

Sixth International Congress on Peer Review and Biomedical Publication

I just found out that the program of this year's Sixth International Congress on Peer Review and Biomedical Publication, to be held on S...

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New tools for Google Services for Websites

<a href="http://googleblog.blogspot.com/2009/03/google-at-your-service.html">Earlier this year</a>, we launched <a href="http://www.google.com/webmasters/provider/index.html">Google Services for Websites</a>, a program that helps partners, e.g., web hoster and access providers, offer useful and powerful tools to their customers. By making services, such as Webmaster Tools, Custom Search, Site Search and AdSense, easily accessible via the hoster control panel, hosters can easily enable these services for their webmasters. The tools help website owners understand search performance, improve user retention and monetize their content — in other words, run more effective websites. Since we launched the program, <a href="http://www.google.com/webmasters/provider/success.html">several hosting platforms</a> have enhanced their offerings by integrating with the appropriate APIs. Webmasters can configure accounts, submit Sitemaps with Webmaster Tools, create Custom Search Boxes for their sites and monetize their content with AdSense, all with a few clicks at their hoster control panel. More partners are in the process of implementing these enhancements. We've just added new tools to the suite: <ul><li><a href="http://www.google.com/webelements/">Web Elements</a> allows your customers to enhance their websites with the ease of cut-and-paste. Webmasters can provide maps, real-time news, calendars, presentations, spreadsheets and YouTube videos on their sites. With the Conversation Element, websites can create more engagement with their communities. The Custom Search Element provides inline search over your own site (or others you specify) without having to write any code and various options to <a href="http://googlecustomsearch.blogspot.com/2009/08/custom-search-with-custom-style-peanut.html">customize further</a>. </li><li><a href="http://code.google.com/speed/page-speed/">Page Speed</a> allows webmasters to measure the performance of their websites. Snappier websites help users find things faster; the recommendations from these latency tools allow hosters and webmasters to optimize website speed. These techniques can help hosters reduce resource use and optimize network bandwidth.</li><li>The <a href="http://www.google.com/webmasters/provider/tips.html">Tips for Hosters page</a> offers a set of tips for hosters for creating a richer website hosting platform. Hosters can improve the convenience and accessibility of tools, while at the same time saving platform costs and earning referral fees. Tips include the use of analytics tools such as Google Analytics to help webmasters understand their traffic and linguistic tools such as <a href="http://translate.google.com/translate_tools?hl=en">Google Translate</a> to help websites reach a broader audience.</li></ul>If you're a hoster and would like to participate in the Google Services for Websites program, please <a href="http://services.google.com/feedback/webmaster_provider_signup">apply here</a>. You'll have to integrate with the service APIs before these services can be made available to your customers, so the earlier you start that process, the better. As always, we'd love to get <a href="http://www.google.com/support/forum/p/Webmasters?hl=en">feedback</a> on how the program is working for you, and what improvements you'd like to see. Posted by Rajat Mukherjee, Group Product Manager

New tools for Google Services for Websites

Earlier this year , we launched Google Services for Websites , a program that helps partners, e.g., web hoster and access providers, offer u...

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AFL/CIO Interested in Healthcare IT Failure?

In today's Wall Street Journal, in a piece entitled "<a href="http://online.wsj.com/article/SB20001424052970204908604574334623330098540.html">You Are Terrifying Us</a>" about the growing opposition to the administration's healthcare reform plan, columnist Peggy Noonan writes: <blockquote>... But every day the meetings seem just a little angrier, and people who are afraid—who have been made afraid, and left to be afraid—can get swept up. As this column is written, there comes word that John Sweeney of the AFL-CIO has announced he’ll be sending in union members to the meetings to counter health care’s [i.e., the reform plan's - ed.] critics.</blockquote> Massive expansion of healthcare IT is one of the cornerstones of the healthcare reform initiative. I have expressed <a href="http://hcrenewal.blogspot.com/2008/12/open-letter-to-president-barack-obama.html">my concerns</a> in an open letter to the President on this blog about the dangers of too rapidly pushing health IT in its present underdeveloped and experimental condition. With that in mind, I've just noted several "hits" on my Drexel website on healthcare IT failure from the following IP number (internet digital address): <blockquote>06 Aug, Thu, 16:22:42 12.4.17.250 Netscape 7 Windows XP 06 Aug, Thu, 16:45:53 12.4.17.250 Netscape 7 Windows XP 06 Aug, Thu, 17:03:07 12.4.17.250 Netscape 7 Windows XP </blockquote> These occurred as a result of someone at IP 12.4.17.250 searching Google on the phrase "drexel university health information tech." I cannot tell what they looked at besides the site's main page at 16:22, but at 16:45 and 17:03 the referring URL's were: <a style="font-style: italic; font-family: arial;" href="http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=about">http://www.ischool.drexel.edu/faculty/ssilverstein/failurecases/?loc=about</a> In other words, my biographical information was being reviewed. IP 12.4.17.250 <a href="http://ip-lookup.net/index.php">translates as follows</a>: <blockquote>AFL-CIO AFLCIO-17-0 (NET-12-4-17-0-1) 12.4.17.0 - 12.4.17.255</blockquote> Perhaps someone at AFL-CIO is interested in pursuing a graduate certificate in healthcare informatics at Drexel, or perhaps someone there is conducting background research on potential or perceived IT-related "impediments" to healthcare reform. (Such as my writings?) I don't know which, but I thought the hits interesting. -- SS Aug. 11 update: This "hit" just in on unknown referrer: <blockquote>Aug, Tue, 08:13:39 12.32.3.194 Netscape 7 Windows XP </blockquote>IP 12.32.3.194 translates to: <blockquote> UNITED STEELWORKERS OF AMERICA UNITED-S 21-3-192 (NET-12-32-3-192-1) 12.32.3.192 - 12.32.3.199 </blockquote> A lot of hits on my HIT failure site with union labels lately. -- SS

AFL/CIO Interested in Healthcare IT Failure?

In today's Wall Street Journal, in a piece entitled " You Are Terrifying Us " about the growing opposition to the administrati...

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SGIM Urges "Chuck the RUC"

This week, <a href="http://www.sgim.org/">Society of General Internal Medicine </a>(SGIM) members received the 5 August, 2009, Update in Health Policy that urged we "chuck the RUC," (quoted in its entirety below, italics added for emphasis): <blockquote> Who will assign the value of primary care services? Chuck the RUC! How does Medicare determine physician payment rates? The answer to this question is a core element of the ongoing debate about health care reform. Changing how Medicare sets payment rates for physicians is especially critical since Medicare rates also guide the rates set by private insurers. Since 1992, Medicare has paid physicians according to the Resource Based Relative Value Scale (RBRVS), a fee schedule that multiplies relative values for physician services by a conversion factor to determine the amount of payment. The Centers for Medicare and Medicaid Services (CMS) has historically used the Relative Value Scale Update Committee, or RUC, as the sole source of recommendations. This committee within the AMA performs broad reviews of the RBRVS every five years. Twenty three of the RUC's twenty nine members are appointed by major national medical specialty societies, including those that account for high percentages of Medicare expenditures for procedures. All meetings are closed and discussions are confidential. The over-representation of procedure-driven subspecialties and under-representation of generalist physicians in the RUC has contributed to the current undervalued cognitive services (especially for primary care) and over-valued reimbursement for procedures. In March 2007, the Medicare Payment Advisory Commission (MedPAC) identified the RUC process as a major reason for undervalued primary care services and a significant contributor to the crisis in primary care. MedPAC has recommended that an independent expert panel of economists, technology experts, physicians and private citizens be created to supplement the RUC's recommendations to CMS regarding fee schedules. Health reform discussions have included moving MedPAC into the executive branch and giving it authority to review and recommend Medicare payment policy, thus reducing the RUC's influence. Not surprisingly, both the AMA and the American College of Surgeons have opposed this proposal. Groups representing primary care physicians, including SGIM, are in favor of this proposal which could ensure fair and unbiased assignment of work RVUs to all the service codes used by physicians. We believe that this will correct the payment inequalities of the current fee scale and ultimately renew trainees' interest in primary care. In the coming weeks, SGIM may ask you to act on this issue and contact your legislators to urge them to support these transformative proposals for primary care. Please monitor your e-mail for action alerts and be prepared to act. </blockquote> We have previously posted (most recently <a href="http://hcrenewal.blogspot.com/2009/06/letter-from-ruc-and-my-reply.html">here</a> in considerable detail) about the perverse incentives given US physicians by the payment schedule dictated by the US Medicare system. These incentives have been largely responsible for the increasingly dire status of primary care/ generalist care in the US. Revisions to the Resource-Based Relative Value System (RBRVS) disproportionately reward physicians for performing procedures and diagnostic tests instead of talking with, examining, thinking about, diagnosing, recommending decisions for, and counseling patients. The US Center for Medicare and Medicaid Services (CMS) uses the RBRVS Update Committee (RUC) de facto as its sole source for advice on revising the system. The RUC is dominated by representatives of medical societies whose members predominantly perform procedures and do diagnostic tests. The RUC is secretive. The identities of its individual members are difficult to ascertain. Its proceedings are secret. Thus, the RBRVS updating process run by the RUC is opaque, unaccountable, and not representative of patients and "cognitive" physicians. The result of this process has been perverse incentives that have driven up health care costs without obvious improvements in quality or outcomes. I applaud SGIM for being the first medical society to challenge how the RUC controls payments to physicians, and the perverse incentives the RUC process has generated. As the Update above says, meaningful health care reform in the US will not occur unless we address the perverse incentives that drive up costs without improving care.

SGIM Urges "Chuck the RUC"

This week, Society of General Internal Medicine (SGIM) members received the 5 August, 2009, Update in Health Policy that urged we "chuc...

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Recreating the Google Chrome icon: videos from around the world

(Cross-posted from the <a href="http://chrome.blogspot.com/2009/08/recreating-google-chrome-icon-videos.html">Google Chrome blog</a>) When I was originally designing the <a href="http://www.google.com/landing/chrome/ugc/chrome-icon.jpg">Google Chrome icon</a>, I went through many iterations to figure out how to best represent our brand new web browser. The design needed to stand out on the desktop, look stable yet dynamic, and use color to show some Google branding. Through the design process, another quality that became important to the team was to make the icon feel like a real, tangible object so that clicking on it would be like pressing a real button. This June, <a href="http://googleblog.blogspot.com/2009/06/get-creative-with-google-chrome-icon.html">we invited users</a> to take the icon and actually build it in a new, creative way. Many people around the world accepted the challenge and submitted fun and surprising videos of their process. We got to see the icon made out of some interesting materials — like <a href="http://www.youtube.com/watch?v=TOGaO7L6QGw">cups</a>, <a href="http://www.youtube.com/watch?v=S_Vn1C7eUzA">dominos</a>, <a href="http://www.youtube.com/watch?v=F0TqJzz1nvE">food</a> and even <a href="http://www.youtube.com/watch?v=XKy0lKQ5kUE">clothing</a> — as well as <a href="http://www.youtube.com/watch?v=pl3nnJVFj_I">many</a> <a href="http://www.youtube.com/watch?v=_vsFW6wKsNc">unique</a> <a href="http://www.youtube.com/watch?v=OF8TioEopKI">digital</a> <a href="http://www.youtube.com/watch?v=HNmXhtExbU4">creations</a>. <a onblur="try {parent.deselectBloggerImageGracefully();} catch(e) {}" href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj2MRuFoZ9F4hd5XhS6hUHLMQo_WOTl3bIajlcY2VU0IbOetu8mwDRw8V1qhlz9Fr5lYjvvr_5gfRo_OuWrFzoFPCjYBb6EefRfsI3afr8vvMWIj3EjQKeaWs4F_wDOfYg85WQPfYdcAOg6/s1600-h/collage.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366642544195012178" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEj2MRuFoZ9F4hd5XhS6hUHLMQo_WOTl3bIajlcY2VU0IbOetu8mwDRw8V1qhlz9Fr5lYjvvr_5gfRo_OuWrFzoFPCjYBb6EefRfsI3afr8vvMWIj3EjQKeaWs4F_wDOfYg85WQPfYdcAOg6/s400/collage.jpg" style="margin: 0px auto 10px; display: block; text-align: center; cursor: pointer; width: 400px; height: 225px;" /></a> I was really impressed by the great care people took in recreating the icon, and I particularly enjoyed this video by Renaud, a fan of Google Chrome in Annecy, France: <center><object height="344" width="425"><param name="movie" value="http://www.youtube.com/v/m22f-77nK3c&hl=en&fs=1&rel=0"><param name="allowFullScreen" value="true"><param name="allowscriptaccess" value="always"><embed src="http://www.youtube.com/v/m22f-77nK3c&hl=en&fs=1&rel=0" type="application/x-shockwave-flash" allowscriptaccess="always" allowfullscreen="true" width="425" height="344"></embed></object></center> A big thank you to everyone who sent us videos. Check out all the submissions <a href="http://www.youtube.com/video_response_view_all?v=bGJOmGL6mYM">here</a>. Posted by Micheal Lopez, Web Design Lead

Recreating the Google Chrome icon: videos from around the world

(Cross-posted from the Google Chrome blog ) When I was originally designing the Google Chrome icon , I went through many iterations to figur...

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Has Ghostwriting Infected The "Experts" With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?

I could have titled this piece "have the deceivers been themselves deceived?" Recent revelations have shown that biomedical ghostwriting is a scourge that some physicians and scientists -- who are clearly lacking ethics, insight and perhaps an understanding of psychiatric defense mechanisms such as rationalization -- engage in all too often, as it taints the corpus of worldwide scientific literature. (I covered the issues related to ethical and justified claims of provenance for scientific writing in my post "Wyeth: Ghostwritten Papers Fake, But Accurate" <a href="http://hcrenewal.blogspot.com/2009/07/wyeth-ghostwritten-papers-fake-but.html">here</a> along with a discussion of why lay leadership of biomedical R&D organizations was not a good idea. Such leaders cannot vouch for the scientific fairness and accuracy emanating from their own organizations.) One should examine the evidence in a first-person manner. The New York Times has made available <a href="http://documents.nytimes.com/design-write-medical-writing">secret documents and emails</a> secured by Senator Grassley on Wyeth's ghostwriting practices. These documents were unsealed by a judge in a personal injury lawsuit and chronicle Wyeth's use of a medical writing company to prepare articles for publication in medical journals. Wyeth said all the articles are "scientifically accurate" and that "it is a common practice in the pharmaceutical industry to work with such firms" (and, by implication, to falsify claimed authorship). As justification for clearly unethical practices, this is a rather poor argument, being a classic logical fallacy known as the <a href="http://www.nizkor.org/features/fallacies/appeal-to-common-practice.html">Appeal to Common Practice</a>: <blockquote>Description of Appeal to Common Practice The Appeal to Common Practice is a fallacy with the following structure: 1. X is a common action. 2. Therefore X is correct/moral/justified/reasonable, etc. </blockquote> That said, these documents raise an important question of a systemic nature: Have the scientific ghostwriting deceivers themselves been deceived regarding biomedical reality by these practices? Might they genuinely believe they are contributing to the scientific literature based on their own erroneous notions, the latter based upon a scientific literature contaminated by other ghostwriters? To illustrate this point, in the New York Times online document pool, we discover that Dr. Gloria Bachmann, Associate Dean for Women's Health and Professor of OB/GYN and Medicine at UNDNJ-Robert Wood Johnson Medical School was presented with a tidy ghostwritten article entitled "The Importance of Treating Vasomotor Symptoms" (in peri- and post-menopausal women) by authors "TBD" (to be decided): <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpfNVCXAffsmRekuHW9VznAj01upkonEa1MGa1YXaE0kCPu-e15jPxm9VsodoXfxp9S1NiSu6TM4owNzlhKT0NYCSUZ8lPts5OVOeQYqs7qWDpAMgOTFhebLVgYBwKDqhApnSnMUARZmCH/s1600-h/Picture+1.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366869892151207106" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEjpfNVCXAffsmRekuHW9VznAj01upkonEa1MGa1YXaE0kCPu-e15jPxm9VsodoXfxp9S1NiSu6TM4owNzlhKT0NYCSUZ8lPts5OVOeQYqs7qWDpAMgOTFhebLVgYBwKDqhApnSnMUARZmCH/s320/Picture+1.jpg" style="cursor: pointer; display: block; height: 427px; margin: 0px auto 10px; text-align: center; width: 323px;" /></a>(Original ghostwritten draft. Authors "TBD." Click to enlarge)</div> about which Bachmann wrote the following in an email to the true authors' organization: <blockquote>"Outline is excellent as written. I would like to try for publication as a review article in Obstetrics and Gynecology. We would have to change the title to "Vasomotor Symptoms: Evidence Based Treatment Options" or a title that emphasizes the data driven writing style."</blockquote> Here is an image of the email: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEglfJCs7MUOzFBfvlngFeXxR74ABCDQpvIgv0XBujGInP40VytV7Zb83dmtpdB4ASnVE4s8wKK0HGkjLGaKrhQCTtKw36K9KB5bCk0XpWuxD0KjtNOYDJqbPJx2j8DdpHGVWOKPMwh-GXcW/s1600-h/Picture+3.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366872232373912850" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEglfJCs7MUOzFBfvlngFeXxR74ABCDQpvIgv0XBujGInP40VytV7Zb83dmtpdB4ASnVE4s8wKK0HGkjLGaKrhQCTtKw36K9KB5bCk0XpWuxD0KjtNOYDJqbPJx2j8DdpHGVWOKPMwh-GXcW/s320/Picture+3.jpg" style="cursor: pointer; display: block; height: 359px; margin: 0px auto 10px; text-align: center; width: 300px;" /></a>(Approval email. Click to enlarge)</div> She found the content OK and agreed to review it. Apparently, only minor changes were made. (Bachmann should have received accreditation in the acknowledgments section for reviewing the article, and/or a position far down the authorship hierarchy if she actually added some material). Instead, the reverse occured. The published document appeared with Bachmann as first (and only) author after Bachmann submitted it to a medical journal under her name, itself unethical. See what "Authors TBD" morphed into in the image below: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFwtod-h29l228wXBF4RE3uSG0PYu6LVv4SFOcQixGn7VEiT3hjC8M7BiUjk_Mhc-O5J9M3YQ-Eq2NVKyv0xMDShshemCGrvFRFN-mIgVzzvBAqqnd13qHvn4aTtfEVPGBseZrOH1o4DRU/s1600-h/Picture+4.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366873203094683218" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEiFwtod-h29l228wXBF4RE3uSG0PYu6LVv4SFOcQixGn7VEiT3hjC8M7BiUjk_Mhc-O5J9M3YQ-Eq2NVKyv0xMDShshemCGrvFRFN-mIgVzzvBAqqnd13qHvn4aTtfEVPGBseZrOH1o4DRU/s320/Picture+4.jpg" style="cursor: pointer; display: block; height: 341px; margin: 0px auto 10px; text-align: center; width: 283px;" /></a>(Article submission cover page. Click to enlarge)</div> Here is how the true authors, medical writers for DesignWrite, the medical writing and communications company retained by Wyeth to write the article, received credit: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgUALG8sej3YfhGCix3j59Kc4gm8mh5HQONCBaHcw9SFHKfBrbMpmQgVbZft7UNEl6C0qfLtdrcS_hG824AYKI4rn-_RN5CP9l95qL2pKcZE8A1XDIh0NeSNfbcxy94nydJfP9IhCgVbhAF/s1600-h/Picture+5.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366880395546903266" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgUALG8sej3YfhGCix3j59Kc4gm8mh5HQONCBaHcw9SFHKfBrbMpmQgVbZft7UNEl6C0qfLtdrcS_hG824AYKI4rn-_RN5CP9l95qL2pKcZE8A1XDIh0NeSNfbcxy94nydJfP9IhCgVbhAF/s320/Picture+5.jpg" style="cursor: pointer; display: block; height: 353px; margin: 0px auto 10px; text-align: center; width: 292px;" /></a>(How the "ghosts" received credit for writing the paper. Click to enlarge)</div> Unbelievable. Bachmann has since stated that she believed she was adding to science by engaging in this deceit. From the New York Times: <blockquote>The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the “gold standard” for treating hot flashes and was less enthusiastic about other therapies. The acknowledgments thanked several medical writers for their “editorial assistance,” not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article. Dr. Bachmann, who has 30 years of research and clinical experience in menopause, said she played a major role in the publication by lending her expertise. Her e-mail messages do not reflect contributions she may have made during phone calls and in-person meetings, she said. ["May have made?" This gossamer excuse is embarrassing to me, as an academic myself - ed.] “There was a need for a review article and I said ‘Yes, I will review the draft and make sure it is accurate,’ ” Dr. Bachmann said in an interview Tuesday. “This is my work, this is what I believe, this is reflective of my view.”…</blockquote> She is quite off base regarding scientific authorship and "this being her work", but what also needs examination is her "lending her expertise" and her agreeing with the paper as "reflective of her view." The paper itself lists many references, for example these: <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhb5ny2qG6A2_7kvtL75s-NPLznznSWCsp03R60pgtjzZnLAZnT0LA6smWFhVSm_79qRKWNRlErRDYz1vjpEdLaazL7TAwr3DQ5mREFpuYkp7yhX5mO_v4oLYdKZot4aFGWM-ZQuVUCOG42/s1600-h/Picture+2.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5366874937593524210" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEhb5ny2qG6A2_7kvtL75s-NPLznznSWCsp03R60pgtjzZnLAZnT0LA6smWFhVSm_79qRKWNRlErRDYz1vjpEdLaazL7TAwr3DQ5mREFpuYkp7yhX5mO_v4oLYdKZot4aFGWM-ZQuVUCOG42/s320/Picture+2.jpg" style="cursor: pointer; display: block; height: 351px; margin: 0px auto 10px; text-align: center; width: 290px;" /></a>(References: click to enlarge)</div> Here is, then, the dilemma, another major problem posed by ghostwriting: How many of the cited references, which contributed to Bachmann's beliefs regarding these drugs, were themselves ghostwritten and potentially biased, or otherwise influenced by drug companies? For that matter, how many studies with different ("negative") conclusions on these subjects were suppressed from publication by industry pressure?  Bachmann's own "expert opinions" about these matters may be based upon false or misleading information she's read in other journals, the percentage of which are genuine vs. ghostwritten or industry-influenced being an unknown at this point in time. While I believe Bachmann is most likely rationalizing away the unethical nature of attribution without fair and justifying contribution, perhaps fueled by additional motives of academic portfolio building and perhaps present and future potential pecuniary gain, it is possible she is being genuine about agreeing with the "science" in the paper. However, her agreement may be predicated upon her own tainted expertise -- tainted by reading ghostwritten or industry-influenced articles in her area of specialty. Will we ever be able to peel back all the layers of the ghostwriting onion to get to the core of impartial and objective scientific articles related to drugs and medical devices? Perhaps not, but the practice must stop going forward. Tainted literature creates tainted scientific knowledge, the carriers of which may then further taint the knowledge base (with the best of intentions and with firm belief in the fairness and accuracy of their activities, of course). Practitioners of evidence-based medicine may be unwittingly practicing "evidence-tainted medicine", or "pseudo-evidence based medicine" as described by others on this blog. Such are the systemic risks of the scourge of ghostwriting. -- SS Aug. 31, 2012 Addendum: I was made aware of the following 2011 paper thanks to a post by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2012/08/ghostwriting-still-no-consequences-for.html">on the Hooked: Ethics, Medicine and Pharma blog</a>:  "<a href="http://psychrights.org/research/Digest/Science4Sale/WhyDoesAcademiaAllowGhostwritingLeoLacasse2011.pdf" target="_blank">Why Does Academic Medicine Allow Ghostwriting?  A Prescription for Reform</a>" by Jonathan Leo, Jeffrey R. Lacasse, and Andrea N. Cimino The paper also observes: <blockquote class="tr_bq">Due to its secretive nature, it is difficult to quantify how many invisible corporate authors haunt the medical literature.</blockquote> The paper is worth reading in its entirety and as of this writing is available free at the link above. -- SS

Has Ghostwriting Infected The "Experts" With Tainted Knowledge, Creating Vectors for Further Spread and Mutation of the Scientific Knowledge Base?

I could have titled this piece "have the deceivers been themselves deceived?" Recent revelations have shown that biomedical ghostw...

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