healthy4u: ghostwriting

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

The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

Before it was abruptly ended by a sudden settlement for $158 million, the trial in Texas of a suit alleging unethical marketing of the drug Respirdal (risperidone) by the Janssen subsidiary of Johnson and Johnson opened yet another window on organized stealth marketing campaigns in health care. (Note that we first discussed this case <a href="http://hcrenewal.blogspot.com/2006/12/guidelines-in-whose-interest.html">here </a>in 2006, and that this trial and the case was ably covered in detail on the <a href="http://1boringoldman.com/">1BoringOldMan blog</a>.)  Even so, given all the recent attempts to dismiss critics of the pharmaceutical industry as "pharmascolds," (e.g., <a href="http://hcrenewal.blogspot.com/2011/09/using-logical-fallacies-to-scold.html">here</a>), and to otherwise uphold the current status quo in our dysfunctional health care system, I thought it would be useful to rediscuss this case to show how systematic stealth marketing threatens the ideals of rational, evidence-based health care. <a href="http://hcrenewal.blogspot.com/search/label/evidence-based%20medicine">Evidence-based medicine</a> may simply be viewed as medicine based on evidence and logic tempered with humanity. A slightly longer definition is practice based on the best evidence from clinical research derived from systematic searches, critically reviewed, used to maximize individual patients' benefits and minimize their harms according to their values. In contrast, brief summaries of sworn testimony during the trial, and of a key report by an expert witness suggested how a commercial health care organization, in this case, the Jennssen subsidiary of Johnson and Johnson, could organize a stealth marketing campaign to promote practice based on deception and falsehoods, entangled in illogic and emotional and psychological manipulation. This was all done to market a product which could not so easily be supported by evidence and logic. Deception and Falsehoods: Suppression of Medical Research A Bloomberg <a href="http://www.businessweek.com/news/2012-02-01/j-j-hid-3-risperdal-diabetes-studies-from-fda-texas-jury-told.html">report</a> of the last day of the trial showed how the Respirdal stealth marketing campaign used the now classic mechanism of suppression of medical research: <blockquote>Johnson & Johnson officials hid three studies showing some patients using Risperdal developed diabetes while claiming the antipsychotic drug didn’t cause the disease, a witness testified. As early as 1999, Johnson & Johnson’s Janssen unit had researchers’ findings that about half the patients taking Risperdal in a study comparing its risks to those of Eli Lilly & Co.’s Zyprexa antipsychotic drug developed diabetes after a year on the medication, Joseph Glenmullen, a psychiatrist and Harvard Medical School instructor, told a Texas jury yesterday. That study concluded Risperdal caused 'medically serious weight gain' that led study subjects to develop diabetes, Glenmullen testified in the trial of the state of Texas’s lawsuit over Janssen’s marketing of the drug. At the same time, Janssen salespeople were telling doctors that researchers concluded the drug didn’t cause the disease, Glenmullen added.</blockquote> In particular, <blockquote>Glenmullen, testifying as an expert for the state, told jurors Janssen officials didn’t turn over Study 113, which found Risperdal posed a higher diabetes risk than Zyprexa, to the U.S. Food and Drug Administration when regulators began probing links between anti-psychotic medications and the disease in 2000. The drugmaker also didn’t turn over the results of two other later studies that found Risperdal and Zyprexa posed comparable diabetes risks to the FDA.</blockquote>Suppression of research is a severe threat to evidence-based medicine because it can severely bias the clinical evidence base on which it depends. Deception and Falsehood: Ghostwriting A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch-the-rothman-report/">published in the Houston Press</a> provided this example of ghostwriting: <blockquote>A member of J&J's Speakers Bureau, [University of Texas Professor of Psychiatry Dr Alexander] Miller collected at least $82,000 from Janssen and its contractors. He declined to comment for this story, saying he may be called as a witness in the lawsuit. Miller was a 'guest author' for one of Janssen's ghostwritten articles. Upon receiving the manuscript, Miller wrote, 'Yes, I am happy to be included as a co-author. I made a few minor edits and comments in the manuscript.'</blockquote>In addition, another <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch/">article</a> in the Houston Press summarizing the issues before the trial provided this overview of the ghostwriting process: <blockquote>As described in the AG's expert witness report, a company called Excerpta Medica was hired to draft some of Janssen's Risperdal articles. In 2003, according to Rothman, Excerpta Medica issued 'Risperidone Publication Program Status Reports,' indicating that 30 of the 145 articles to be published had authors listed as 'to be determined.' Rothman also examined what he considered a signature ghostwritten piece meant to boost Risperdal's pediatric profile; the study is included in the 2010 parameters. Rothman cited a barrage of e-mails between Excerpta Medica and J&J in crafting the article. At one point, an Excerpta Medica employee wrote, 'It would be very helpful to receive some guidance in relation to the flow, format and subject in this paper and whether you think this is too marketing oriented or not, in order to prepare a next draft. Besides that we would like [to] have some suggestions for external authors on this paper. Maybe [a] U.S. and a European KOL? Your input will be much appreciated.'' The article eventually appeared in a 2007 volume of the European Journal of Child and Adolescent Psychiatry. For a lead author, J&J scored a heavy hitter: Dr. Peter Jensen, former associate director of child and adolescent research at the National Institute of Mental Health, and the founding director of the Center for the Advancement of Children's Mental Health at Columbia University. Now with the Mayo Clinic, Jensen declined to comment for this story.</blockquote> This indicates the scope of this particular ghostwriting initiative: 145 articles were planned.  Thus, ghostwritten articles could comprise a major proportion of the apparently scholarly literature relevant to Risperdal.  Ghostwriting is fundamentally deceptive because it allows marketing to appear in the guise of scholarly work.  Ghostwritten reviews can deceptively shift the focus from the questions that need to be addressed by the evidence-based process to benefit patients to those whose answers would benefit marketers. Deception and Falsehoods: Key Opinion Leaders Emotional and Psychological Manipulation: Creation of Conflicts of Interest An important element of most stealth marketing campaigns is the creation of <a href="http://hcrenewal.blogspot.com/search/label/key%20opinion%20leaders">key opinion leaders</a>.  These are academics or professionals who can promote products in the guise of unbiased expertise.  A summary of the 86 page report by Professor David Rothman commissioned by the Texas Attorney General <a href="http://www.houstonpress.com/2011-12-15/news/down-the-hatch-the-rothman-report/">published in the Houston Press</a> provided the example of Dr Steven Shon: <blockquote>As the head of the state's mental health agency, Shon was perhaps Janssen's most crucial key opinion leader; his influence in pushing Risperdal was invaluable. He accepted at least $47,000 from Janssen and its medical ghostwriter, Excerpta Medica, and signed an agreement to be a member of Johnson & Johnson's Speakers Bureau. Rothman writes, 'The medical director of the state's mental health agency should not be serving as an official spokesperson for a pharmaceutical company whose product state agencies are purchasing.' The company paid for his trips across the country, and even overseas, to promote Risperdal as a safe and effective medication. (But the romance between Janssen and Shon was not without its bumps; Shon would get 'upset' if the checks he accepted from Janssen were made out to the MHMRA instead of directly to him. Apparently, those were more difficult to funnel into his personal account.) Shon retired in 2005, allowing him to collect his taxpayer-funded pension. He moved to Las Vegas, where he's the director of psychiatry for a mental health and substance abuse clinic called Harmony Healthcare. Shon was so influential that Janssen grew paranoid and possessive when it learned that other companies sought his partnership as well. When J&J employee Yolanda Roman heard that Eli Lilly had flown him to their headquarters on a private jet, she wrote, "Steve I suppose is enjoying the vast attention and response he can command from Industry...Obviously, Steve has the right to be served by all Industry, let's hope he remains fair [and] balanced and remembers who PLACED HIM ON THE 'TMAP' MAP." Meanwhile, another employee busted out the caps-lock to warn that "WE WILL NOT LET LILLY OR PFIZER PREVAIL WITH OUR MOST IMPORTANT PUBLIC SECTOR THOUGHT LEADER."</blockquote> Similarly, a Bloomberg <a href="http://www.bloomberg.com/news/2012-01-11/johnson-johnson-paid-texas-official-to-speak-around-the-u-s-jury-told.html">report</a> of Dr Shon's trial testimony included: <blockquote>Johnson & Johnson’s Janssen unit paid a Texas mental health official to speak around the U.S. about state guidelines on prescribing antipsychotic drugs that gave preference to medicines like the company’s Risperdal, the official said. Steven Shon accepted honorariums to fly to Arizona, Florida and New Jersey to discuss Texas guidelines developed in 1999 advising doctors that a newer class of drugs like Risperdal were a “first choice or option” for schizophrenia, he testified today in state court in Austin.</blockquote> Also, <blockquote>Attorneys for Jones questioned Shon, who served as medical director of the Texas Department of Mental Health and Mental Retardation until he involuntarily retired in 2006. Shon testified that he served on Janssen advisory boards, was a board member of a Janssen publication called 'Mental Health Issues Today' and was a continuing medical education speaker in programs sponsored by the company. Shon was asked about six trips in which he got honorariums of $3,000 from Janssen to discuss the TMAP project. In several cases, he kept those payments, he said. In testimony yesterday, a Texas Medicaid investigator said Shon signed several consulting agreements with Janssen, and the company paid him $47,587 over several years. </blockquote> Dr Shon's value to Janssen derived from his position as the respected leader of the state's mental health agency. While he was apparently paid by Janssen marketers who saw him as an ally, his marketing was all the more effective because it seemed to come from an unbiased expert. As such it was deceptive. The <a href="http://iom.edu/Activities/Workforce/ConflictOfInterest.aspx">Institute of Medicine report on conflicts of interest</a> defined them as "a set of circumstances that creates a risk that professional judgment or actions regarding a primary interest will be unduly influenced by a secondary interest." The report, and indeed much of the discussion of conflicts of interest in health care assumes that most secondary interests are "-within limits - legitimate and even desirable goals." For example, an academic physician who also was a basic scientist could be paid by a pharmaceutical company to do a specific assay on samples used in research. In that case, the payments could conceivably create a risk that the academic's professional judgment in a clinical setting would be unduly favorable to the products of the company. However, the relationship hardly seems intended to cause such a bias. Notions that conflicts of interest are "inevitable" but "manageable" may stem from consideration of conflicts of interest like this. However, conflicts of interest deliberately created as perverse incentives may be much more consequential, and as this example shows, perhaps not rare. It appears that Janssen paid Dr Shon not to do some task that was unrelated to how he fulfilled his primary entrusted responsibilities as director of mental health, but in order to influence how he fulfilled them. We have noted previous examples in which corporate marketers consider paid key opinion leaders as sales people (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>). Such conflicts are deliberately created so that the recipient of payments uses his or her entrusted responsibilities to serve the vested interests of the payer may be deceptive, as noted above.  Furthermore, by being intended to induce changes in how the payee performs his or her primary responsibilities, these conflicts are particularly likely to lead to abuse of these entrusted responsibilities. Given that the <a href="http://www.transparency.org/news_room/faq/corruption_faq">Transparency International definition of corruption</a> is abuse of entrusted power for private gain, we need a new and more incisive term to described this variety of conflicts of interest. The motivation of key opinion leaders by created conflicts of interest can result in powerful manipulation of the key opinion leaders, but more importantly of their audience.  Emotional and Psychological Manipulation: Intimidation Another Bloomberg <a href="http://www.bloomberg.com/news/2012-01-12/j-j-whistle-blower-recounts-firing-after-finding-payments.html">report</a> included testimony about how someone who attempted to blow the whistle about the Respirdal stealth marketing campaign was intimidated: <blockquote>Allen Jones testified yesterday in state court in Austin, Texas, that he was an investigator in the Pennsylvania Office of Inspector General in 2002 when he looked into an unregistered bank account run by Steven Fiorello, the pharmacist. Fiorello was on a Pennsylvania committee weighing whether to require doctors to give priority to newer, more expensive drugs like Risperdal in state-funded treatment of mental-health patients, Jones said. Jones, 57, said he found a $4,000 check from J&J’s Janssen unit to Harrisburg State Hospital that was sent “\'to the attention of' Fiorello. The check covered a Fiorello trip to New Orleans to discuss Pennsylvania’s drug guidelines. Another check for $1,766 to the hospital account was sent 'in care of' of Fiorello, Jones said. Fiorello controlled the account and didn’t register it with the state, Jones said. 'The account was used to deposit money from drug companies,' Jones said yesterday in the trial’s third day of testimony. 'There were real problems here. On many levels, the account was improper.' Janssen also paid $2,000 directly to Fiorello as an honorarium for his speaking at a company-sponsored event in 2002, Jones said. Jones said he followed the money trail and explored efforts by Janssen to promote, on a state-by-state basis, Texas guidelines favoring drugs like Risperdal. The funds sent to the hospital account helped pay travel expenses for programs related to setting up the Texas guidelines in Pennsylvania, he said. The state adopted the guidelines that favored Risperdal in 2003, Jones said. </blockquote> Note that this testimony appears to be about yet another KOL paid to promote guidelines that would in turn promote the marketing of Respirdal. So this is yet another case of a conflict of interest apparently deliberately created to influence the individual's primary responsibility. However, then <blockquote>Jones said his boss told him to ease off his probe. He said he was told, 'Stay away from the drug companies. This is a personnel issue. Stay away from the drug companies, stay away from TMAP. Jones said his boss said, 'Drug companies write checks to both sides of the aisle. Stay away from it.' His boss told him that 'morally and ethically I was correct, but politically, this was dead.' Jones said that later he was removed as the lead investigator from the case, and he was 'marginalized completely.' He continued to pursue the case on his own time, and spoke to the New York Times for a story that ran Feb. 1, 2004. He said he was fired for talking to the newspaper. </blockquote> So Jones was intimidated to the extent that he lost his job. Note further that the implication is that this intimidation stemmed from yet more conflicts of interest created by Janssen, payments to politicians. This underlines how stealth marketing campaigns become complex systems. Note further that in retrospect, Jones' complaints were deemed true by a court of law and a state commission: <blockquote>Fiorello, once the chief pharmacist for Pennsylvania’s public welfare department, was convicted in December 2008 of felony conflict-of-interest charges for taking payments from drug companies, including Janssen and Pfizer Inc. He was sentenced to 18 months of probation and fined $3,000. He also paid more than $27,000 in civil fines after the Pennsylvania Ethics Commission cited him. </blockquote>In a sense, intimidation and created conflicts of interest are two sides of the same coin.  Both involve the deliberate imposition of incentives, either positive or negative.  These incentives are designed to further marketing aims and organizational interests, not to improve patient care or public health, or advance science.  Thus they are powerful tools of emotional and psychological manipulation. Summary Note that even the brief summaries of trial evidence suggested how systematic the campaign was, and how within it, the elements of deception and falsehoods (instead of evidence), and emotional and psychological manipulation (instead of logic and humanity) were predominant. This should be added to previous discussion of <a href="http://hcrenewal.blogspot.com/search/label/stealth%20marketing">stealth marketing campaigns</a>, including such examples as that of Neurontin <a href="http://hcrenewal.blogspot.com/2006/08/stealth-marketing-of-neurontin.html">here</a>). Stealth marketing campaigns are complex examples of how behavior meant to further vested interests may directly threaten evidence-based practice, physicians' professionalism, and ultimately patients' and the public's health. There have been many calls (e.g., see recent posts <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">here</a> and <a href="http://hcrenewal.blogspot.com/2011/11/if-medical-school-is-just-part-of.html">here</a>) for increased "collaboration" among health professionals and academics and industry.  Often they are justified by the need for "innovation," while resulting conflicts of interest are deemed "manageable."  The current examples show how the vested interests of health care organizations operating within a laissez faire, anything goes environment may make such collaboration poisonous.

The Texas TMAP Trial as Illustration of a Systematic Stealth Marketing Campaign

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10 Feb 2012

Defending Academic Whistleblowers: Call Out the Marines?

At "<a href="http://hcrenewal.blogspot.com/2011/09/academic-medicine-deploys-logical.html">Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths</a>" Roy Poses wrote about the illogic employed by academia to weaken draft rules for researchers to disclose conflicts of interest. Another major component of research in academia might be termed "gangster tactics against whistleblowers on wrongdoing." In the following <a href="http://www.pogo.org/resources/public-health/amsterdam-complaint-to-gutmann-re-evans-et-al-misconduct-20110708.html">July 8, 2011 letter</a> to Dr. Amy Guttmann, President of the University of Pennsylvania (courtesy the Project on Government Oversight or POGO), a Penn psychiatry researcher, Dr. Jay Amsterdam, has retained a law firm to represent him in alleged research misconduct by others at Penn, specifically Dwight Evans, the Chair of the Department, and an Associate Professor Dr. Laszlo Gyulai (note: I have never met and do not know any of the people involved): <blockquote>"Dear Dr. Guttmann, On behalf of my client, Dr. Jay Amsterdam, Professor of Psychiatry at the University of Pennsylvania, I would like to inform you that we have filed a charge of research misconduct with the Office of Research Integrity (OR!) against Dr. Dwight L. Evans, Professor of Psychiatry and Chairman of the Department of Psychiatry at the University of Pennsylvania, and Dr. Laszlo Gyulai, Associate Professor of Psychiatry at the University of Pennsylvania. I have enclosed a copy of the complaint and referenced documents for your reference. As chairwoman of President Barack Obama's Presidential Commission for the Study of Bioethical Issues, I feel certain you will deal with this matter in a just and sincere fashion. <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgFgtT962Efu8-gpfcRYG7kk8975vsX86dRBFgGFGOIuhWHAVS_vmgK4BDh-U3-t6QFUUjmEEoGlZbwQY-S8LpeJ0B5P6HKSQ9t8X2sFehndKgXueq84E53D7guaE8dn_beFFhbVaOspYgb/s1600/guttman.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5652590687739063698" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEgFgtT962Efu8-gpfcRYG7kk8975vsX86dRBFgGFGOIuhWHAVS_vmgK4BDh-U3-t6QFUUjmEEoGlZbwQY-S8LpeJ0B5P6HKSQ9t8X2sFehndKgXueq84E53D7guaE8dn_beFFhbVaOspYgb/s320/guttman.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 255px; height: 320px;" /></a>Letter, page 1 (click to enlarge) </div><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEg1aOv-Vr6o3qy1-iOMV9mh4lSLef5PjGr0sBsNzs7JTKsg92sZAiEiawooTx2fvXV79VTQQTog74xOMnwIG9syuihF_J6gkSNi_4QE6TBtaHJ5TFUDGaB7jDmayO4lJI2eK6m6ztwafotq/s1600/guttman.jpg"> </a> <div style="text-align: center;"><a href="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEie1LrZfOQ_TDSIWFhlGVmINoBbW-bcNkaRe4yWU2JcCrayjDrQN_4czphOnxjnEX81Tpse6FZCRDyn-ryGY7bMd4RDjTHCKOiNM6FM8sUAKMY9J3HXF742VQqbsbsjOgfXYhacTtLMLbuW/s1600/guttmannp2.jpg"><img alt="" border="0" id="BLOGGER_PHOTO_ID_5652591223811191458" src="https://blogger.googleusercontent.com/img/b/R29vZ2xl/AVvXsEie1LrZfOQ_TDSIWFhlGVmINoBbW-bcNkaRe4yWU2JcCrayjDrQN_4czphOnxjnEX81Tpse6FZCRDyn-ryGY7bMd4RDjTHCKOiNM6FM8sUAKMY9J3HXF742VQqbsbsjOgfXYhacTtLMLbuW/s320/guttmannp2.jpg" style="display: block; margin: 0px auto 10px; text-align: center; cursor: pointer; width: 249px; height: 320px;" /></a>Letter, page 2 (click to enlarge) </div></blockquote> The allegations are not in themselves surprising (at least to me). The complaint is that the defendants misappropriated data from a study conducted by the plaintiff, manipulated the data, and used it in a ghostwritten article by a major journal, the American Journal of Psychiatry, in a concealed marketing effort to increase sales of Paxil by GSK. We have documented many examples of this type of behavior in medical research at this blog. (By way of my not being surprised by such allegations, I personally have been involved as junior Yale faulty in that research university's professors' attempts to misappropriate my IP, a computer program I wrote for a Yale collaboration on birth defects in the Arab world, for their own use. My internal complaints were followed by severe retaliation, up to the level of blacklisting and extortion. Those attempts were aided by, of all things, an Associate General Counsel who was not authorized to practice law in the state, apparently not having taken the Law Boards. I put an end to that effort through legal means. This was followed a number of years later by attempted misappropriation of the same property by a Johns Hopkins-affiliated professor with his own software company in a DoD proposal. I also put an end to the latter effort, which involved informing the DoD.) However, my purpose here is not to comment on the allegations of research misconduct. It is to comment on a subject that occupies three of the four paragraphs in the above letter - protection from retaliation: <blockquote>... By filing this complaint, I expect my client to receive full and complete protection from retaliation and/ or defamation by either the University of Pennsylvania and/ or any other parties involved in publishing the referenced study. [E.g., GSK - ed.] It is my client's belief that the data from his study was effectively stolen from him, manipulated and used in a ghostwritten article published in the American Journal of Psychiatry in order to advance a marketing scheme by GlaxoSmithKline to increase sales of Paxil. If any acts of retaliation and/or defamation are taken against my client, I will immediately inform ORI and the Health and Human Services Office of the Inspector General. Furthermore, it is my understanding that several congressional committees have expressed an interest in investigating the problem of research misconduct and ghostwriting in academia and, thus, I intend to allow my client to fully cooperate with any investigation and will inform Congress of any retaliation against him for such cooperation. To ensure this complaint is taken seriously, and to alert interested parties, I am providing copies of this correspondence to Senator Charles Grassley, Senator Herb Kohl, and the Chairman and Ranking members of the House Energy and Commerce, and the House Committee on Oversight and Government Reform. </blockquote>About the only resources left out of the list of protectors of the plaintiff from abuse are the Marines ... and perhaps a threat of "Frontier Justice." That a law firm must include explicit threats to expose retaliation against whistleblowers to high-ranking members of Congress suggests Research universities and their corporate allies have become more like the Mafia than centers of novel scientific discovery. This all reminds me of my Jan. 13, 1999 letter to the editor in the Journal of the American Medical Association (JAMA) entitled "<a href="http://jama.ama-assn.org/content/281/2/135.2.extract">Academic and Legal Aspects of Authorship Disputes</a>." As a result of my Yale experience (which, incidentally, also probably damaged nascent cross-cultural progress due to the unusual aspect of my work in facilitating improved care of children with birth defects in a Middle Eastern oil-producing Kingdom), I wrote a response to a July 1998 JAMA article on growing authorship disputes and abuses at Harvard Medical School ("<a href="http://jama.ama-assn.org/content/280/3/216.abstract">Authorship: The Coin of the Realm, The Source of Complaints</a>" by then-Ombud Linda J. Wilcox). I wrote: <blockquote> Jan. 13, 1999 To the editor: I was alarmed by the statement in the article on authorship by Ms Wilcox [1] saying, "It is unreasonable for institutions to promise that they can protect individuals from retaliation for coming forward to complain through formal grievance procedures." Most organizations have policies on retaliation, especially with regard to grievances. If enforced, these policies can discourage such behavior and ensure the victim of redress. In addition, retaliation such as that mentioned in the public and federal sectors is downright illegal, and university employees fall under Department of Labor workplace standards and laws for their respective states. Universities have serious ethical and credibility problems if they have such poor control over their employees that they cannot promise to protect individuals from actions contrary to their own grievance policies and that are probably illegal.</blockquote> I continued on with the argument that lawlessness in universities was counterproductive and needed to be halted, but Ms. Wilcox' reply was more platitudinous than substantive about the 'helplessness' of universities in protecting their own from retaliation. It seems little has changed. To expect the best research from such an environment is like expecting silk purses to be manufactured by pork producers. -- SS

Defending Academic Whistleblowers: Call Out the Marines?

At "Academic Medicine Deploys a Logical Fallacy to Avoid Disclosing Inconvenient Truths" Roy Poses wrote about the illogic employed by academia to weaken draft rules for researchers to disclose confli…

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15 Sep 2011

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 ghostwriting is a scourge that some physicians and scientists -- who are clea…

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06 Aug 2009

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