healthy4u: medical journals

Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

The April 26, 2014 issue of the prestigious journal Lancet used two full pages and two separate articles by the same author to discuss the ascension of the Gates Foundation new CEO, Dr Susan Desmond-Hellmann.(1-2) Two Somewhat Redundant Lancet Articles Dr Desmond-Hellmann trained as an oncologist, spent time working on AIDS and Kaposi's Sarcoma in Uganda, but then spent much of her career as a pharmaceutical/ biotechnology executive, as described in the first article,(1) <blockquote class="tr_bq">After returning from Uganda, Desmond-Hellmann joined the nascent Taxol development programme at Bristol-Myers Squibb, before being poached by Arthur Levinson, the then Head of Research and Development at Genentech. Levinson was convinced Genentech had a strong pipeline of anticancer therapies, and brought Desmond-Hellmann on board to help guide them through to approval. The pipeline went stratospheric, and took Desmond-Hellmann with it. By 2009 she had been promoted to President of Product Development, having overseen the introduction of two of the first gene-targeted therapies for cancer, bevacizumab and trastuzumab.</blockquote> After Genentech was bought out by Roche, Dr Desmond-Hellmann became Chancellor of the University of California, San Francisco, <blockquote class="tr_bq">Over the next 5 years, Desmond-Hellmann instituted wide-ranging reforms at UCSF, including aggressively cutting administrative waste and putting a greater emphasis on partnerships with the biotech and pharmaceutical sectors, coming in for some criticism in the process. 'Some of the press suggested one of Sue's goals was to take UCSF out of the public system', says [current UCSF interim Chancellor Sam] Hawgood. 'Nothing could be further form the truth. She was very proud of the public mission of UCSF, and had no intent to alter that.' Mindful of how damaging perceived conflicts of interest could have been to her credibility during her time at UCSF, Desmond-Hellmann says she 'specifically avoided being on pharma and biotech boards'.</blockquote> The article suggested we should expect nothing but great things from Dr Desmond-Hellmann at the Gates Foundation, <blockquote class="tr_bq">it is Desmond-Hellmann's ability to forge partnerships and her wide network of contacts, rather than her knack for cutting administrative overheads, that will have seemed most attractive to the Gates Foundation as it looks to speed up the process of translating research into results.</blockquote> The second article used remarkably similar wording(2), e.g., regarding her career in the pharmaceutical business, <blockquote class="tr_bq">Soon after joining the Taxol team, Desmond-Hellmann was leading it; the kind of progress that was bound to catch the eye of Genentech's then Head of Research and Development Arthur Levinson. What happened next is part of pharmaceutical folklore, as Desmond-Hellmann helped to mastermind one of the most profitable drug-development pipelines in history, including the approval of two of the first targeted cancer therapies, for Genentech.</blockquote> Also, regarding her career at UCSF,(2) <blockquote class="tr_bq"> Desmond-Hellmann from embarking on a programme of structural reforms to cut administrative inefficiency and forge closer links with private industry, something that still stirs up controversy. 'There definitely were concerns, and there remain concerns in academia, about conflicts of interest, privatisation. I think what helped most was that I was clear in my actions that I did and do value that UCSF is a public institution, and I think my actions spoke and speak for themselves', she says. But Desmond-Hellmann is robust in her defence of the importance of public—private partnerships for driving innovations that ultimately benefit society.</blockquote> Finally, regarding expectations for her performance in the future, <blockquote class="tr_bq">'There are a lot of people who are looking to the foundation, and in the world of philanthropy there's a lot of visibility to the Bill & Melinda Gates Foundation, so I certainly feel accountable and responsible for doing a good job.' But, she asserts, 'I'm up for it'. With a track record that ranges from clinical research, global health, and the sharp end of commercial drug development, she seems to be made for it.</blockquote> So Lancet, a very well known journal which normally is very parsimonious about its use of the printed page, used two full pages for two very similar articles about the new Gates Foundation CEO.  Both articles made the same points, -  Dr Desmond-Hellmann had a brilliant career in the pharmaceutical/ biotechnology business, and was responsible for the development of several important cancer drugs -  Dr Desmond-Hellmann made major reforms at UCSF, including pushing for some sort of privatization, and for public-private partnerships, while dismissing concerns about any resulting conflicts of interest  -  Dr Desmond-Hellmann is likely to be very successful as Gates Foundation CEO. What the Articles Did Not Say When Dr Desmond-Hellmann's appointment as Chancellor of UCSF was announced in 2009, I <a href="http://hcrenewal.blogspot.com/2009/05/bio-tech-u.html">suggested</a> that she was a very unusual choice because of aspects of her track record in the pharmaceutical/ biotechnology business.  Yet the Lancet's two articles on her prospects as new Gates Foundation CEO ignored these considerations, and ignored or downplayed aspects of her track record as UCSF Chancellor.  In particular, Defending $55,000/ Year Bevacizumab As I noted in 2009, Dr Desmond-Hellmann's defense as a Genentech executive of the sky high prices the company was charging for its new drugs was well documented in an article in the Journal of the National Cancer Institute)(3) <blockquote class="tr_bq">And cancer biologics, though among the most costly drugs, are still only a tiny fraction of total GDP, said Genentech's Susan Desmond-Hellmann, president for product development, at AACR. Hellmann and others argue that with these drugs’ potential to alleviate the huge societal burden of cancer, biologics are worth the cost. The industry has responded to concerns about costs by putting more resources into patient assistance programs. When Genentech received U.S. Food and Drug Administration approval for bevacizumab in lung cancer last October, it also announced a cap on expenditures for the drug for patients with family incomes less than $100,000 a year. In 2005, the median household income was $46,326. Originally announced as $55,000, the cap actually doesn't kick in until after a patient has received 10,000 mg. At the wholesale acquisition cost, 10,000 mg is about $55,000, said Genentech spokesperson Edward Lang. What the companies have not done so far is reduce prices. The reason, industry representatives say, is the need to recoup massive research and development costs, including high manufacturing costs for biologics. These costs have long kept biotech companies from making much of a profit overall, Hellmann said. She noted that profit levels of publicly held biotech firms have 'hovered close to zero' throughout the life of the industry.</blockquote> Whatever the company's nominal profit levels, its executives, including Dr Desmond-Hellmann, have made extremely good money.   According to <a href="http://www.sec.gov/Archives/edgar/data/318771/000095013408004633/0000950134-08-004633-index.htm">Genentech's 2008 proxy statement</a>, (the last available, since the company has been bought out by Roche), Dr Desmond-Hellmann's total compensation was $8,361,348 in 2007 and $7,820,142 in 2006. In 2007, her total compensation was equal to 0.3% of the firm's total net income. Of course, since 2007, and especially since 2009, the problem of hugely expensive pharmaceuticals as a driver of health care costs, especially in the US, has become all too apparent.  The Lancet articles were completely silent about this aspect of Dr Desmond-Hellmann's track record, and what implications it might have for her new role of a foundation that spends $3 billion a year, mainly ostensibly to improve the health of poor people. Since she began as Chancellor of UCSF in 2009, other aspects of Dr Desmond-Hellmann's track record came to light that might have a bearing on how she will conduct herself as Gates Foundation CEO.  Investments in Tobacco Stocks As I <a href="http://hcrenewal.blogspot.com/2010/06/smoke-detector-medical-center-leader.html">posted</a> in 2010, then NY Times reporter Duff Wilson discovered that Dr Desmond-Hellmann and her husband (also a physician), had stock holdings in Altria, the parent company of tobacco company Phillip Morris USA, worth between $100,000 and $1,000,000.  When this made public, they abruptly sold the stock.  The head of the UCSF tobacco control center then said,  “I do find that kind of shocking, but at least she got rid of it,...” The goals of tobacco companies seem completely antithetical to those of a medical school, especially one with a tobacco control center, and incidentally seem antithetical to those of the Gates Foundation, which has a <a href="http://www.gatesfoundation.org/What-We-Do/Global-Policy/Tobacco-Control">tobacco control initiative</a>, with a stated goal: <blockquote class="tr_bq">to reduce tobacco-related death and disease in developing countries by preventing the initiation of new smokers, decreasing overall tobacco use, and reducing exposure to secondhand smoke. </blockquote> The Lancet articles were silent on this issue.   Questions Whether Industry Partnerships Threaten the University Mission In 2011, I <a href="http://hcrenewal.blogspot.com/2011/10/logical-fallacies-to-support-putting.html">posted</a> about Dr Desmond-Hellmann's vigorous push to create public-private partnerships, which seemed meant to turn UCSF into a de facto drug company research and development contract shop.  At the time, I noted that many of her arguments seemed to be based on logical fallacies, and that she never provided any good evidence for her claims of marvelous new "innovations" that would result from such supposed partnerships.  The Lancet articles did not mention any substantive concerns about this issue. Dismissing Concerns about Conflicts of Interest In 2012, I <a href="http://hcrenewal.blogspot.com/2012/02/logical-fallacies-in-defense-of.html">posted</a> about how Dr Desmond-Hellmann also dismissed concerns that public-private partnerships could lead to damaging conflicts of interest, again employing several logical fallacies.  In particular, she implied that medical academics should no longer just do research to advance knowledge, but had become responsible for getting their "discoveries to society," and therefore would have to "start a company or work with a company to commercialize a product."  She did not seem to acknowledge the possibility that academics could make discoveries, but perhaps other people would be better at turning these discoveries into useful products.  The Lancet articles were silent on these issues. Minimizing Concerns about Conflicts of Interest due to Membership on the Board of Corporations with Health Care Agendas As noted above, Dr Desmond-Hellmann stated that she demonstrated her sensitivity to the issue of conflicts of interest affecting academic health care by avoiding membership on boards of directors of "pharma or biotech" companies.  These, of course are not the only sorts of for-profit corporations who have health care agendas.  This statement appears to have been carefully worded to avoid dealing with Dr Desmond-Hellmann's membership since 2010 on the board of directors of Procter & Gamble (see the company's <a href="http://www.pginvestor.com/file.aspx?IID=4004124&FID=19227491&O=3&OSID=9">2013 proxy statement</a>.)   While Procter & Gamble is no longer a major pharmaceutical company, it has a <a href="http://www.pg.com/en_US/brands/global_health_grooming/index.shtml">Global Health and Grooming unit</a>, whose products include over the counter pharmaceuticals (e.g., Pepto-Bismal, Metamucil, Prilosec OTC).  Also, while Procter & Gamble does not make it very obvious, it has also owned MDVIP, a company that employs physicians to provide concierge medical services, since 2010, although as Cincinnati.com just <a href="http://www.cincinnati.com/story/money/business/2014/05/02/pg-sells-concierge-medicine-unit/8622903/">reported</a>, it will soon sell this unit to private equity.   So while perhaps Dr Desmond-Hellmann could claim that while she was UCSF Chancellor she was not on the board of directors of any pure pharmaceutical or biotechnology company, she was certainly on the board of a major international company that sells pharmaceuticals and other health care related products, and employs physicians to provide direct patient care.  (Presumably, she will be staying on the P&G board while she is Gates Foundation CEO.)  The Lancet did not mention this issue.  Privatizing UCSF Also, the Lancet articles seemed to contradict other reports that Dr Desmond-Hellmann made a serious attempt to privatize at least some aspects of UCSF, but that this effort failed. (Note that quote by Dr Hawgood from the first article above.)     However, in 2012, I posted about a prevalent conspiracy theory that University of California managers were trying to take the university private.  However, it seemed to be more of a theory, because at least one news report included statements that Dr Desmond-Hellmann wanted to take UCSF out of the state university system.  This week, an <a href="http://www.bizjournals.com/sanfrancisco/blog/2014/04/university-of-california-uc-ucsf-janet-napolitano.html">article</a> in the San Francisco Business Times suggested that this was a serious plan, in that Dr Desmond-Hellmann <blockquote class="tr_bq">ran into opposition when she  <a href="http://pubads.g.doubleclick.net/pagead/adview?ai=B46LUcTVlU4KNFIrUkwT0tYG4DYnY2pwFAAAAEAEgADgAWJmX6YiuAWDJvriM1KSoEIIBF2NhLXB1Yi05NzM2MDkyNjA0Njc3NTE2sgETd3d3LmJpempvdXJuYWxzLmNvbboBCWdmcF9pbWFnZcgBCdoBa2h0dHA6Ly93d3cuYml6am91cm5hbHMuY29tL3NhbmZyYW5jaXNjby9ibG9nLzIwMTQvMDQvdW5pdmVyc2l0eS1vZi1jYWxpZm9ybmlhLXVjLXVjc2YtamFuZXQtbmFwb2xpdGFuby5odG1smALohAHAAgLgAgDqAiI0NjM1L2J6ai5zYW5mcmFuY2lzY28vYXJ0aWNsZV9wYWdl-AL00R6QA-ADmAPgA6gDAeAEAZIFCwgHEAEYByDp888YoAYg&sigh=t4VXjjLVbHw&adurl=http://pagead2.googlesyndication.com/pagead/imgad?id=CICAgKCNn-yIxgEQARgBMggPKtH7CIiUnA%26t%3D10%26cT%3Dhttp%253A//bizjournals.com%26l%3Dhttp%253A//www.bizjournals.com/sanfrancisco/blog/2012/01/susan-desmond-hellmann-ucsf-uc.html">proposed in early 2012 that some of UCSF's functions be separated from the rest of the UC system</a>. The autonomy coming from the separation, Desmond-Hellmann argued at the time, would have meant that the sole graduate-level-only campus in the 10-campus UC system would no longer subsidize UC undergrad programs. It also would have translated into UCSF having more control over the money it generates from its medical center and other operations.</blockquote> However, the same article noted that the current University of California President, <blockquote class="tr_bq">dismissed as 'loose talk' a more than two-year-old plan for UCSF to weaken its ties to the larger UC system. 'UCSF is firmly part of the system and will remain so,...' </blockquote>The current president seemed to thus acknowledge that this plan existed, however "loose" it may have been.  Clearly, the Lancet articles suggested rather that Dr Desmond-Hellmann did not have any privatization plans, whatever the criticisms people could have made of them.   Summary We have often discussed the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, how it seems taboo to discuss certain unpleasant facts and issues relevant to the health care system, especially those that might lead to questions about the abilities of the current leadership of large health care organizations.  This taboo seems to particularly affect public discourse within the health care system, such as is found in medical and other scholarly health care journals. The Lancet is one of the largest circulation and most prestigious medical journals.  The Gates Foundation is one of the biggest foundations working in the health care sphere.  In their <a href="http://www.gatesfoundation.org/Who-We-Are/General-Information/Letter-from-Bill-and-Melinda-Gates">latest letter</a>, Bill and Melinda Gates stated, <blockquote class="tr_bq">Our foundation is teaming up with partners around the world to take on some tough challenges: extreme poverty and poor health in developing countries, and the failures of America’s education system.</blockquote> Yet when the Lancet devoted two full pages to often repetitive discussion of the new leader of the Gates Foundation, it avoided discussion of several issues that might have lead to questions about whether her future leadership would really be about challenging "poor health in developing countries," rather than promoting the interests of large pharmaceutical/ biotechnology and other health care related companies, as she had apparently tried to do before.  That such an important medical journal would publish such incomplete health news reporting suggests the operation of the anechoic effect. I hope the questions that ought to be raised about Dr Desmond-Hellmann's priorities as CEO of the Gates Foundation will eventually be put to rest.  It would be more reassuring, however, if they could be confronted directly rather than obfuscated.  As long as big health care journals remain so deferential to big health care leaders, concerns we have raised before about whether health care is now primarily lead by a small in-group of executives and managers who may put private interests ahead of entrusted responsibilities remain acute. As we have said many, many times, true health care reform would ensure that leaders of big health care organizations really put patients' and the public's health ahead of private interests.  References 1.  Holmes D. New CEO takes the reins at the Gates Foundation.  Lancet 2014; 383: 1440.  Link <a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960702-9/fulltext">here</a>. 2.  Holmes D. Susan Desmond-Hellmann taking charge at the Gates Foundation.  Lancet 2014; 383: 1455.  Link<a href="http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2814%2960706-6/fulltext"> here</a>. 3.  McNeil C. Sticker shock sharpens focus on biologics.  J Nat Cancer Instit 2007; 99: 910-914.  Link <a href="http://jnci.oxfordjournals.org/content/99/12/910.extract">here</a>. ADDENDUM - Material about MDVIP as subsidiary of Procter & Gamble added 5 May, 2014 PM.

Abort, Retry, Fail? - Lancet Avoided Much Recent Unpleasantness in Reporting on New Gates Foundation CEO (Including Her Defense of $55,000 a Year for Bevacizumab)

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05 May 2014

The $20 Million Dollar Journal Editor

Last week, the Milwaukee Journal-Sentinel <a href="http://www.jsonline.com/watchdog/watchdogreports/80036277.html">reported</a> on a royally paid journal editor: <blockquote>In 2002, Thomas Zdeblick, a University of Wisconsin orthopedic surgeon who has pocketed millions of dollars in royalties from the spinal device maker Medtronic, took over as editor-in-chief of a medical journal about spinal disorders. It would be the beginning of a beautiful friendship. In the years to come, Zdeblick would receive more than $20 million in patent royalties from Medtronic for spinal implants sold by the company. And the medical journal he edited would become a conduit for positive research articles involving Medtronic spinal products, a Journal Sentinel analysis found. Zdeblick took over editorship of the Journal of Spinal Disorders & Techniques seven years ago. Since then, studies involving Medtronic spinal products or that were funded by Medtronic appeared in the journal at least once per issue, on average. Dozens of studies that mentioned Medtronic products have been published while Zdeblick has been editor. But in issue after issue, readers of the journal were not told that he was receiving millions of dollars in royalty payments from Medtronic at the same time. Most of the time the articles, including some co-authored by Zdeblick himself about devices for which he gets royalties, had good things to say about the Medtronic products. Only on a small number of occasions did the articles find major problems with Medtronic devices. And often the articles did not disclose financial ties the authors had to Medtronic. </blockquote> Here are some specifics: <blockquote>From 2003 through 2007, Zdeblick got more than $19 million in royalty payments for spinal devices from Medtronic, according to a January 2009 letter by U.S. Sen. Charles Grassley (R-Iowa), who has been investigating payments to orthopedic surgeons by Medtronic. In 2008, Zdeblick got another $2 million from Medtronic from royalties and working as a consultant, according to UW records. To assess the relationship, the Journal Sentinel reviewed every article published in the journal since Zdeblick became editor. The journal is published seven or eight times a year and typically has a dozen or so articles. The articles were searched to see if Medtronic products were used as a part of the study or if the study was funded by Medtronic. At least 70 such articles were found in 56 issues of the journal from 2002 through October 2009. • A 2005 study by researchers in France found favorable preliminary results with Medtronic's Maverick artificial disc. In 2007, Medtronic paid Zdeblick $144,000 in royalties for the Maverick disc, according to Grassley's letter. •  In August 2009, Zdeblick co-authored a study that involved Medtronic's Premier Anterior Cervical Plate as well as the plate of another company, Synthes. The study involved using two different kinds of bone grafts with the plates. Zdeblick got $654,000 in Premier royalties from Medtronic in 2007. •  Zdeblick also co-authored three articles, in 2002, 2003 and 2005, involving Medtronic's BMP-2 and the LT-Cage, a device that paid him $1.4 million in royalties in 2007. None of those studies disclosed that he received millions of dollars in royalties from Medtronic. Often articles in the journal had good things to say about Medtronic products: •  In the 2002 study, Zdeblick and the co-authors concluded that BMP-2 and the LT-Cage led to a solid union and high fusion rates. In the 2003 study they found that BMP-2 may become 'the new gold standard.' •  In a 2006 study, a different group of authors concluded that BMP-2 when used with a hip bone graft significantly improved the success of the fusion surgery with minimal risk to the patient. The 2005 French study of Medtronic's Maverick artificial disc that did not involve Zdeblick concluded it was a 'promising therapeutic technique.' </blockquote> Dr Zdelblick declined to comment for the Journal-Sentinel, but: <blockquote>In a statement, a spokesman for the spinal journal said Zdeblick has disclosed his financial relationship with Medtronic to the company that publishes the journal, Wolters Kluwer Health/Lippincott Williams & Wilkins. All manuscripts submitted to the journal go through a rigorous review process using reviewers who have an objective viewpoint, Robert Dekker, director of communications with Philadelphia-based Wolters Kluwer Health & Pharma Solutions, said in a statement. 'Thanks to our strict peer review policies and processes, we have no concerns about the existence of this relationship,' Dekker said in an e-mail. Dekker declined to provide a list of the reviewers used by the journal or information about their financial relationships with device companies. He also declined to comment on how Zdeblick made decisions about manuscripts and reviewers. </blockquote> Of course, as the Journal-Sentinel pointed out, editors can make publication decisions independent of the recommendations of peer-reviewers. They also are free to select peer-reviewers who might have a particular viewpoint about a manuscript, its topic or authors, and to make and enforce editorial suggestions for changes in manuscripts.  It is beyond me what good that disclosure of conflicts of interest to a for-profit publishing corporation does in the absence of further disclosure.  Keep in mind also that the division of Wolters Kluwer that publishes the journals, <a href="http://www.wolterskluwer.com/WK/About+Us/Divisions/HealthPharmaSolutions/">Wolters Kluwer Health & Pharma Solutions</a>, not only publishes journals and textbooks, but "provides marketing and publications services, business intelligence products, and advanced analytical tools and services" to pharmaceutical corporations. Furthermore, <blockquote>'It's absolutely a conflict,' said Richard Smith, the former editor of the British Medical Journal. At a minimum, Zdeblick's conflict should be fully disclosed by his journal whenever a study involving a Medtronic product is published, said Smith, the author of 'The Trouble with Medical Journals.' However, because he makes so much money from Medtronic royalties, he really should not be editing the journal at all, Smith said. </blockquote> Just to add icing to the cake, Prof Margaret Soltan <a href="http://www.margaretsoltan.com/?p=20313">pointed out</a> on her University Diaries blog that Dr Zdeblick is not only a journal editor, but a Professor and <a href="http://www.orthorehab.wisc.edu/sportsmedicine/research/zdeblick.shtml">Chairman of Orthopedics and Rehabilitation</a> at the University of Wisconsin.  In addition, his web-page at the University notes that he is on the <a href="http://journals.lww.com/spinejournal/Pages/EditorialBoard.aspx">editorial board</a> of another orthopedics journal, Spine, also published by Wolters Kluwer Health.  So here we go again.  How should we assess the objectivity of an ostensibly scholarly medical journal whose editor was made rich by royalties from a company whose devices were often evaluated in the articles published in the journal?  How should we assess the honesty of a journal editor who received millions in royalties from Medtronic, but who only deigned to disclose as an author in his own journal, "One or more of the author(s) has/have received or will receive benefits, (e.g., royalties, stocks, stock options, decision making position) for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript." (as in Zdelblick TA, Phillips FM. Interbody cage devices.  Spine 2003; 28: S2-S7.)  (Note that this sort of disclosure seems to be standard operating procedure for orthopedic surgeons who make millions from royalties and consulting fees, e.g. see <a href="http://hcrenewal.blogspot.com/2008/06/more-multi-million-dollar-orthopods.html">this post</a>.) Prof Zdelblick had numerous opportunities to influence his colleagues, trainees, and students in his roles as journal editor, journal editorial board member, author of scholarly articles, and professor and chair of orthopedics.  At the very least, the people who read his journal or his articles, listened to his lectures, or participated in his clinical teaching should have at least had the opportunity to judge for themselves whether being paid over $20 million might have just biased what he wrote and said a tiny bit.  But can anyone doubt that $20 million dollars would profoundly influence one's thinking?  Can anyone doubt that an inventor who got rich from royalties might not be more enthused about the use of the devicesthat generated the royalties than would an academic whose salary is unrelated to the use of any device?   It seems to be an abuse of entrusted power for a journal editor, professor, and department chairman not to clearly disclose such huge conflicts of interests to readers, learners and colleagues. This is just the latest vivid example of the conflicts of interest that permeate health care.  When multi-million dollar men pretend to be unbiased editors and professors, is it any wonder that we regularly overuse and overvalue the devices and drugs that they are selling? ADDENDUM (6 January, 2010) - See also comments <a href="http://spineblogger.blogspot.com/2009/12/old-news-is-well-old-news.html">on the Spine Blogger</a>, and by Dr Howard Brody <a href="http://brodyhooked.blogspot.com/2010/01/increasing-price-of-medical-journal.html">on the Hooked: Ethics, Medicine and Pharma blog</a>.

The $20 Million Dollar Journal Editor

Last week, the Milwaukee Journal-Sentinel reported on a royally paid journal editor:In 2002, Thomas Zdeblick, a University of Wisconsin orthopedic surgeon who has pocketed millions of dollars in royal…

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28 Dec 2009

How Industry Views the Research It Sponsors

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

How Industry Views the Research It Sponsors

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30 Nov 2009

BLOGSCAN - Merck Hired Elsevier to Create Fake Peer-Reviewed Medical Journal

You just can't make this stuff up. <a href="http://scienceblogs.com/insolence/2009/05/when_big_pharma_pays_a_publisher_to_publ.php">On the Respectful Insolence blog</a>, Orac recounted how pharmaceutical giant Merck hired medical publishing giant Elsevier to create what appeared to be a peer-reviewed journal, but theAustralasian Journal of Bone and Joint Medicine really was just a marketing outlet. The goal was to market Fosamax and Vioxx. This is another bizarre variant on the stealth marketing theme, taken to quite an extreme. And the pharmaceutical companies wonder why people don't trust them? ADDENDUM (4 May, 2009) - Dr Aubrey Blumsohn is <a href="http://scientific-misconduct.blogspot.com/2009/04/fake-editorial-board-of-mercks-fake.html">back online </a>on his Scientific Misconduct Blog, and noted the academic luminaries who were willing to serve on the editorial board of this fake peer-reviewed journal. ADDENDUM (11 May, 2009) - See also <a href="http://laikaspoetnik.wordpress.com/2009/05/08/mercks-ghostwriters-haunted-papers-and-fake-elsevier-journals/">comments</a> on Laika's MedLibBlog.

BLOGSCAN - Merck Hired Elsevier to Create Fake Peer-Reviewed Medical Journal

You just can't make this stuff up. On the Respectful Insolence blog, Orac recounted how pharmaceutical giant Merck hired medical publishing giant Elsevier to create what appeared to be a peer-reviewed…

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04 May 2009

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