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Diversity Nightmare And Federal Antidiscrimination Laws: Cleveland Clinic CEO Delos M. Cosgrove Would Proudly Discriminate Against Fat People

The following stunning quote appeared in the Nov. 27, 2009 Newsweek article "<a href="http://www.newsweek.com/id/224585">The Hospital That Could Cure Health Care</a>" about the Cleveland Clinic: <blockquote>[Cleveland Clinic president and CEO Dr. Delos M. Cosgrove, a former cardiac surgeon] has even taken on the most intractable driver of American health-care costs: Americans. Having already banned the hiring of smokers (a dictate enforced by urine tests for nicotine), Cosgrove declared this year that if it weren't illegal under federal law, he would refuse to hire fat people as well. The resulting outcry led him to apologize for "hurtful" comments. But he has not backed down from his belief that obesity is a failure of willpower, which can be attacked by the same weapons used to combat smoking: public education, economic incentives, and sheer exhortation.</blockquote> My thoughts come from the perspective of a former fitness-for-duty evaluator and drug testing officer (Medical Review Officer) for the regional transit authority in a very large city, and a hiring manager in the hospital and pharmaceutical sectors. I find a profoundly discriminatory statement that a hospital CEO would "refuse to hire fat people" if he could get away with it, and that he refuses to hire smokers and forces people (presumably candidates) to take a urine nicotine test, totalitarian and highly abhorrent. Nothing about smoking or obesity [except in very specialized job situations for the latter] makes a person unfit to work in a hospital. This attitude is exactly why we have federal anti-discrimination laws, to protect people from biased autocrats like this. I should add that talent apparently is irrelevant to this autocrat; if a person is overweight, this self-righteous SOB would send an applicant out the door. So much for talent management if he could get his way. One wonders if he would also send current employees who are overweight out the door - if he could get away with it. A May 2008 USA Today article entitled "Weight discrimination could be as common as racial bias" <a href="http://www.usatoday.com/news/health/weightloss/2008-05-20-overweight-bias_N.htm">here</a> made the point that: <blockquote> <div class="inside-copy">Weight discrimination, especially against women, is increasing in U.S. society and is almost as common as racial discrimination, two studies suggest. Reported discrimination based on weight has increased 66% in the past decade, up from about 7% to 12% of U.S. adults, says one study, in the journal Obesity. The other study, in the International Journal of Obesity, says such discrimination is common in both institutional and interpersonal situations — and in some cases is even more prevalent than rates of discrimination based on gender and race. (About 17% of men and 9% of women reported race discrimination.) Among severely obese people, about 28% of men and 45% of women said they have experienced discrimination because of their weight. "Weight discrimination is a very serious social problem that we need to pay attention to," says Rebecca Puhl of the Rudd Center for Food Policy and Obesity at Yale University, a co-author of both studies. ... Institutional discrimination involved health care, education or workplace situations, such as cases in which people said they were fired, denied a job or a promotion because of their weight. Interpersonal discrimination focused on insults, abuse and harassment from others.</div> </blockquote> This raises several questions: <ul><li>The CEO of an organization sets the tone. What does such a statement about "fat people" do to staff morale?</li></ul><ul><li>As a result of this CEO's stated preferences, is there subtle or covert discrimination against overweight employees at the Cleveland Clinic, preventing promotions and/or causing or contributing to situations of <a href="http://www.answers.com/topic/constructive-discharge">constructive discharge</a>?</li></ul><ul><li>Is there subtle or covert hiring discrimination against overweight candidates, with the hiring managers knowing the CEO's expressed views? </li></ul><ul><li>One also wonders if this CEO has similar attitudes towards gays, minorities, and people with physical and emotional disorders that also would not affect their ability to perform their jobs.</li></ul><ul><li>How well does the Cleveland Clinic respect other aspects of diversity considerations in its hiring, firing, and job promotion practices?</li></ul><ul><li>What kind of care and quality of staff interactions do overweight people receive/experience at the Cleveland Clinic?</li></ul> This CEO will not be "curing healthcare" any time soon IMO, since a primary consideration is compassion. He seems somewhat deficient in that attribute. He also seems deficient in the characteristic known as business wisdom, especially in an era of competition and trigger-finger litigation. His statement could be used by competitors to steer people away from the Cleveland Clinic and its affiliates. It could very likely also be used in support of discrimination lawsuits against the Cleveland Clinic and its affiliates by current, former, and potential employees (as well as by overweight patients, conceivably) which can be very expensive and damaging to an organization's reputation. In addition to all of the problems exhibited by healthcare leaders as covered on this blog, I add a new one apropos to this CEO's cerebral anatomy: <a href="http://thesaurus.reference.com/browse/fathead">fathead</a>. -- SS

Diversity Nightmare And Federal Antidiscrimination Laws: Cleveland Clinic CEO Delos M. Cosgrove Would Proudly Discriminate Against Fat People

The following stunning quote appeared in the Nov. 27, 2009 Newsweek article " The Hospital That Could Cure Health Care " about the...

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"We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause ..."

In my post "<a href="http://hcrenewal.blogspot.com/2009/11/academic-freedom-and-ed-ehrs-down-under_10.html">Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development</a>" I reported on the Univ. of Sydney's somewhat belated support for academic freedom, and the reappearance of an essay on ED electronic health records problems in NSW by one of its informatics faculty, Prof. Jon Patrick, after an apparently government-initiated attempt at censorship. A new update of the paper "A Critical Essay on the Deployment of an ED Clinical Information System - Systemic Failure or Bad Luck" version 6, has now been posted by Dr. Patrick <a href="http://www.it.usyd.edu.au/~hitru/index.php?option=com_content&task=view&id=91&Itemid=146">at this link</a> on his department's web pages (a direct link at this time to the PDF is <a href="http://www.it.usyd.edu.au/~hitru/essays/The%20Story%20of%20the%20Deployment%20of%20an%20ED%20Clinical%20Information%20System6.0.pdf">here</a>). The press has started to take notice. A piece in the Sydney Morning Herald entitled "Health department accused of censorship" appeared on Nov. 28 <a href="http://www.smh.com.au/national/health-department-accused-of-censorship-20091127-jwwm.html">here</a>. That piece was noted by Computer Weekly in the U.K. in a piece entitled "Claim of censorship over Cerner system" <a href="http://www.computerweekly.com/blogs/tony_collins/2009/11/claim-of-censorship-over-cerne.html">here</a>. The U.K. suffers a severe EHR epidemic (the UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is <a href="http://www.publications.parliament.uk/pa/cm200809/cmselect/cmpubacc/153/15304.htm">here</a>.) [12/3/09 update: the piece has disappeared, then reappeared, at Computer Weekly. In case it disappears again, a copy of the article from Google's cache is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/claim_of_censorship_cerner.doc">here</a>.] From the U.K. Computer Weekly article: <blockquote> The Sydney Morning Herald and ZDNet in Australia report that the University of Sydney removed from its website - temporarily - a negative essay about a Cerner system which had been installed at hospitals in New South Wales. The author of the essay is a medical IT professor, Jon Patrick, who is reported to have claimed that NSW Health, which is part of the government of New South Wales, put pressure on the university to take down the paper. If true, it would tie in with what's been happening in England where mentions of Cerner in a negative context are being officially discouraged. Cerner is due to be installed at hospitals across London as part of the National Programme for IT [NPfIT] but several trusts that have already gone live - including the Royal Free and Hampstead, Barnet and Chase Farm, and Barts and The London - have run into serious problems, including the losing of patient appointments and patients not being treated. A showcase Cerner site at Homerton ceased mentioning Cerner in its public board papers after doing a deal with NHS Connecting for Health and the Department of Health. Homerton also rejects FOI requests related to its discussions on Cerner. Homerton told me: "We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence."</blockquote> I am repeating that last sentence for effect: <blockquote> We are unable to share documents relating to these meetings as our contract with Cerner includes a confidentiality clause and as such disclosure of the information could give rise to an actionable breach of confidence.</blockquote> This is solid evidence of such confidentiality clauses in HIT contracts and the chilling effect they have, along with dangers of "hold harmless" clauses. This style of EHR contracting is a practice now under investigation by the U.S. Senate Committee on Finance, as in their Oct. 16, 2009 letter to major healthcare IT vendors and management consultants from Senator Charles E. Grassley (ranking member). A copy of that letter is <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/grassley_erecords102409.pdf">here</a> (PDF). I have written on the dangers of such clauses before as in my July 22, 2009 letter in the Journal of the American Medical Association "Health Care Information Technology, Hospital Responsibilities, and Joint Commission Standards" (<a href="http://jama.ama-assn.org/cgi/content/extract/302/4/382" rel="nofollow">http://jama.ama-assn.org/cgi/content/extract/302/4/382</a>), as well as my much more thorough posting on these issues in the essay at my Drexel University website <a href="http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=koppel_kreda">here</a>. In that essay I observed: <blockquote>Regarding healthcare IT "Hold Harmless" and Defects Gag Clauses, I also question whether hospital executives violated their fiduciary responsibilities by signing such contracts, and violated Joint Commission standards of hospital leadership conduct as well ... Let's look at the Joint Commission Hospital Accreditation Program <a href="http://www.jointcommission.org/Standards/SII/sii_hap_ld.htm">Leadership Chapter</a>, and its standards for hospital leadership (<a href="http://www.jointcommission.org/NR/rdonlyres/D53206E8-D42B-416B-B887-491B6D5AA163/0/HAP_LD.pdf">link</a>, PDF): <o:p></o:p>Leadership LD.01.03.01 Standard LD.01.03.01 The governing body is ultimately accountable for the safety and quality of care, treatment, and services. Rationale for LD.01.03.01 The governing body’s ultimate responsibility for safety and quality derives from their legal responsibility and operational authority for [organization] performance. In this context, the governing body provides for internal structures and resources, including staff, that support safety and quality. <o:p></o:p> The governing body has a legal responsibility for safety and quality, not just a moral obligation. One of the "internal structures" is healthcare IT that is safe and effective and that does not expose patients or staff to undue risks. How does signing "hold harmless" and "defects gag order" clauses with an HIT vendor serve such a purpose, exactly? Hospital executives know, should know, or should have known that such provisions would remove incentives for health IT vendors to produce the best products and to correct deficiencies rapidly, thus increasing risk to patients and clinicians.<o:p></o:p>Elements of Performance for LD.01.03.01 5. The governing body provides for the resources needed to maintain safe, quality care, treatment, and services. <o:p></o:p> One of those resources is health IT.<o:p></o:p>Standard LD.02.01.01 The mission, vision, and goals of the [organization] support the safety and quality of care, treatment, and services. Rationale for LD.02.01.01 The primary responsibility of leaders is to provide for the safety and quality of care, treatment, and services. The purpose of the [organization]’s mission, vision, and goals, is to define how the [organization] will achieve safety and quality. The leaders are more likely to be aligned with the mission, vision, and goals when they create them together. The common purpose of the [organization] is most likely achieved when it is understood by all who work in or are served by the [organization]. <o:p></o:p> How is a contract with an HIT vendor that calls for hiding defects in health IT and exposing staff to liability for defects in same serving the above purposes?<o:p></o:p> Standard LD.02.03.01 The governing body, senior managers and leaders of the organized medical staff regularly communicate with each other on issues of safety and quality. <o:p></o:p> Does that include communication on health IT defects? Can a medical staff member ask to see a database of such defects when the hospital has signed a nondisclosure of defects agreement with an HIT vendor?<o:p></o:p>Rationale for LD.02.03.01 Leaders, who provide for safety and quality, must communicate with each other on matters affecting the [organization] and those it serves. <o:p></o:p> I ask the same question as above.<o:p></o:p> Standard LD.03.01.01 Leaders create and maintain a culture of safety and quality throughout the [organization]. <o:p></o:p> Safety for whom, exactly? Patients, or patients and staff? How is exposing professional staff to undeserved liability from defective health IT serving the creation of a culture of safety and quality for them? How is suppressing information on health IT defects and problems helping patient safety and care quality? How is lack of seeking informed consent on health IT use from patients whose care is mediated by health IT devices with known but undisclosable defects creating a culture of quality? How is hiding such defects creating a culture of quality in the community's other hospitals, that may be considering purchase of the very same health IT?<o:p></o:p>Standard LD.03.04.01 The [organization] communicates information related to safety and quality to those who need it, including staff, licensed independent practitioners, [patient]s, families, and external interested parties. Rationale for LD.03.04.01 Effective communication is essential among individuals and groups within the [organization], and between the [organization] and external parties. Poor communication often contributes to adverse events and can compromise safety and quality of care, treatment, and services. Effective communication is timely, accurate, and usable by the audience. <o:p></o:p> Are physicians and nurses explicitly informed by administration that clinicians are liable for bad outcomes due to software problems? Are they informed of the gag clause? Are patients informed of unremediated health IT defects existing at time of service? This standard seems a veritable smoking gun regarding breach of fiduciary responsibility and Joint Commission obligations when hospital leadership signs agreements specifically excluding the sharing information about health IT defects and complaints. It is already known that hospitals maintain lists of health IT defects, some in the thousands of items. A number of the defects rise to the level of creating considerable risk to patients, and nobody is in a hurry to remediate them. (See my proposed although somewhat tongue in cheek "HIT Informed Consent" that describes some of these known defect categories <a href="http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html">here</a>).<o:p></o:p>Standard LD.04.04.03 New or modified services or processes are well-designed. ... 3. The hospital's design of new or modified services or processes incorporates: Information about potential risks to patients. 4. The hospital's design of new or modified services or processes incorporates: Evidence-based information in the decision-making process. Note: For example, evidence-based information could include practice guidelines, successful practices, information from current literature, and clinical standards.<o:p></o:p> How does the contractual inability to communicate about health IT defects, which its executives willingly sign, serve this purpose?<o:p></o:p>Standard LD.04.04.05 The [organization] has an organization-wide, integrated [patient] safety program. ... 12. The hospital disseminates lessons learned from root cause analyses, system or process failures, and the results of proactive risk assessments to all staff who provide services for the specific situation.<o:p></o:p> Disseminates lessons learned, except when the HIT contract they've signed with a vendor forbids it, that is. The practices of the health IT industry, and the dealings of the hospital leadership with that industry, may in fact be a scandal of national (or international) proportions.<o:p></o:p><a href="http://www.infoplease.com/ce6/society/A0818616.html"></a></blockquote> International scandal, indeed. I predict these EHR confidentiality clauses will end up causing great loss of money in failed systems, and/or harming patients, due to the chilling effect they have on revelation of defects and problems by clinicians and executives alike. Those who signed them will very likely be held liable, at least in the U.S., as the clauses breach the safety standards of the accrediting agency for hospitals here, the Joint Commission. I wish the signers of such contracts good luck in the courtroom. In Australia and the U.K., I cannot comment, but also wish good luck to those who signed these clauses when lawyers go full court press on EHR-mediated debacles. -- SS

"We are unable to share documents relating to problematic EHR's as our contract with Cerner includes a confidentiality clause ..."

In my post " Academic Freedom and ED EHR's Down Under: Another Update and a Welcome Development " I reported on the Univ. of S...

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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

We have posted frequently about threats to the integrity of the clinical evidence-based, and to the practice of evidence-based medicine. In...

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More Evidence for Suppression of Research: the Case of Lamictal for Depression

We recently <a href="http://hcrenewal.blogspot.com/2009/11/editorial-that-wasnt-evidence-for.html">discussed</a> the severe challenges to evidence-based medicine presented by <a href="http://hcrenewal.blogspot.com/search/label/manipulating%20clinical%20research">manipulation</a> and <a href="http://hcrenewal.blogspot.com/search/label/suppression%20of%20medical%20research">suppression</a> of clinical research to serve vested interests.  I recently (and unfortunately belatedly) came upon yet another example of suppression of research that was unfavorable to a research sponsor's vested interests, suggesting that such suppression may be more prevalent than heretofore believed.  This example appeared in the journal Evidence-Based Mental Health [Gahemi SN. The failure to know what isn't known: negative publication bias with lamotrigine and a glimpse inside peer review.  Evidence Based Mental Health 2009; 12: 65-68.  Link <a href="http://ebmh.bmj.com/content/12/3/65.full">here</a>.] The author was able to use the database of clinical trials provided by GlaxoSmithKline as part of a settlement of a suit by former New York state Attorney General Elliot Spitzer that charged that the company had suppressed information about the selective serotonin reuptake inhibitor paroxetine (Paxil).  His interest was the use of lamotrigine (Lamictal) in depression.  His main findings were: <blockquote>Of the nine lamotrigine related bipolar disorder studies posted on the website (see table 1), two were positive and published supporting the FDA approved indication for delay of relapse in the long term treatment for bipolar disorder patients. A negative study in rapid cycling bipolar disorder and another in acute bipolar depression were published but both emphasised positive secondary outcomes as opposed to the negative primary outcomes. Five other negative studies involving rapid cycling bipolar disorder, acute bipolar depression and acute mania have not been published and are only available on the GSK website. Failure to adequately publish these negative studies led to the creation of a clinical impression that lamotrigine is an 'antidepressant,' a view innocently expressed to me as recently as last week by an academic colleague. This mistaken impression occurred partly because the prophylactic benefits of lamotrigine for depressive episodes were confused with a presumed acute benefit. Partly it was due to the publication of one apparently positive study, and the non-publication of several negative studies. The clinical relevance of the lamotrigine studies is notable: taking the negative outcomes into account, as of now, one might say that this agent is reasonably effective in maintenance treatment of bipolar disorder, particularly in prevention of depression. It is proven ineffective in acute mania, rapid cycling disorder and acute bipolar depression. </blockquote> Note that Dr Ghaemi and colleagues had published a summary of the suppressed negative articles in Medscape Journal of Medicine in late 2008.  [Ghaemi SN, Shirzadi AA, Filkowski M. Publication bias and the pharmaceutical industry: the case of lamotrigine in bipolar disorder. Medscape J Med 2008; 10(9):211.  Link <a href="http://www.medscape.com/viewarticle/579046_1">here</a>.]  That earlier article also documented the group's failed attempts to discover whether negative trials of other drugs for depression had been suppressed. Dr Ghaemi's newer made some additional important points about suppression of clinical research.  The first is that it is occurring with the acquiescence of government regulators. In particular, <blockquote>It is worth mentioning that the [US] FDA [Food and Drug Administration] has encouraged this state of affairs, by viewing negative studies as uninformative, due to the possibility of being 'failed' rather than truly negative (ie, the sample may have simply been unresponsive, or dosing might have been too low and so on). Thus drugs could have two positive studies, and 10 or so negative ones (as did a number of selective serotonin reuptake inhibitors),8 and the FDA not only allowed approval but it did not require that the pharmaceutical industry publish its negative results. The pharmaceutical industry did the minimum necessary; the FDA set the minimum far below what should have been the acceptable scientific standard. Furthermore, even though the FDA is supposed to allow access to information about all studies for drugs for which it provides an indication, in fact it still does not allow access to raw data from industry sponsored studies, which are viewed as confidential and proprietary. Rather, in my experience and those of colleagues who have attempted to access such studies, Freedom of Information Act requests are met with abstracted summary results. While summary results are better than no results, full access to scientific data should be the standard at the FDA. </blockquote> The second is that medical journal reviewers and editors do not seem enthused about publishing articles about how research has been suppressed (an apparent example of the <a href="http://hcrenewal.blogspot.com/search/label/anechoic%20effect">anechoic effect</a>, or perhaps the anechoic effect squared, i.e., discussion of our failure to discuss research studies whose results did not please their sponsors is simply not done.) <blockquote>In the course of trying to investigate and publicise these negative findings, we ran into numerous roadblocks, as I discussed in an interview for the Carlat Report last year </blockquote> Instead of repeating what I have said before about the evils of suppressing clinical research, I will offer some concluding quotes from Dr Ghaemi. <blockquote>Evidence based medicine—or, more simply put, the science of medicine—cannot be taken seriously, and is certainly not valid, if the evidence base is only partial. The scientific literature currently is like an under cooked meal which we think is ready to eat. We never know whether what we see in the evidence is correct or biased in one direction or the other. Meta-analyses of large published datasets are not as meaningful as they seem when unpublished data languish elsewhere. </blockquote>Manipulation and suppression of clinical research has likely misled doctors and patients into using and paying too much for minimally effective, ineffective, or even harmful drugs and devices.  Manipulation and suppression of research is thus probably a major reason that health care costs much more than its value and accessibility warrants.  To truly reform health care, we should not let those with vested interests in selling health care products or services control the clinical research that purports to evaluate what they are selling.

More Evidence for Suppression of Research: the Case of Lamictal for Depression

We recently discussed the severe challenges to evidence-based medicine presented by manipulation and suppression of clinical research to ...

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What is the "Worst Biotech CEO" Worth?

Recently, we <a href="http://hcrenewal.blogspot.com/2009/11/genzymes-remarkable-businessstrategy.html">posted</a> about misadventures of the leadership of biotechnology giant Genzyme.  Although the company has long priced its drug Cerezyme for the rare Gaucher's disease at a stratospheric level, it did not sufficiently reinvest money in its manufacturing facility for the drug.  Deferred maintenance at a production facility running at maximum capacity has apparently lead to two different kinds of contamination problems, forcing a shut-down of the plant, and now a shortage of the drug.  For this, Genzyme CEO Henri Termeer was just labeled the "Worst Biotech CEO of '09" <a href="http://www.thestreet.com/story/10627877/genzymes-termeer-worst-biotech-ceo-of-09.html">by TheStreet.com</a>. It was not always thus.  A 2008 <a href="http://www.bostonmagazine.com/articles/so_this_is_what_a_biotech_tycoon_looks_like/">profile</a> of Mr Termeer in Boston Magazine chronicled the rise of Genzyme from a "startup [which] operated 15 stories above the Combat Zone in an old garment building on a dodgy stretch of Kneeland Street."  Termeer pushed the company to develop a practical way to manufacture Cerezyme, and had the vision that the company could make money selling the drug to a relatively small number of patients.   Of course, his solution was to price the drug so high as to "drop jaws."  However, perhaps that was what was needed to get a innovative drug to a small number of patients. Furthermore, Termeer posited that the revenues derived from drugs such as Cerezyme would lead to innovations that would help many more people. <blockquote>The biotech tycoon's immodest goal is to change healthcare. That is what he's trying to do, after all. That's part of why he doesn't sweat the bad press, which he regards as the penance of the innovator. His therapies for ultrarare diseases, he says, point the way forward, toward a day when very targeted drugs cure ailments perfectly, precisely. Don't think of his niche therapies as being used by tiny, statistically inconsequential groups; think of them as being deployed in ways that get results every time. Now contrast this with the trial-and-error approach that dominates medicine as it's practiced today, in which doctors pick and choose from the menu of drugs available and calibrate dosages until finally, hopefully, they land on what works best for that particular person. What if instead every condition had a drug that was the smart bomb that Cerezyme is for Gaucher's? </blockquote> While we wait for these marvelous new innovations, however, patients with Gaucher's disease must wait for their effective but amazingly expensive drug apparently because Mr Termeer presided over the failure to pay enough attention to mundane issues like manufacturing plant maintenance while he touted his vision of the future. Whether that vision is realistic depends on one's view of Mr Termeer's predictive abilities. The Boston Magazine article suggested he is not a good fortune teller.  In 1994, Mr Termeer "suggested to the [New York] Times that the cost [of Cerezyme] would soon drop. 'Once we have the new plant running and approved, we will start to see some economies of scale,' Termeer told the paper in 1994. 'We can start to pass on some of these economies to the marketplace while at the same time improving the financial results of the company.' Fourteen years later, the price of Cerezyme has never come down. In my humble opinion, the tale of Henri Termeer's and Genzyme's current woes tells a lot about the culture of leadership now prevalent in health care. On one hand, it seems that some of the business-people who took over leadership of health care organizations had administrative skills that turned innovative ideas into reality. This success may have derived from real vision about the possibilities of high-technology medicine and health care. On the other hand, as their administrative abilities and vision lead to success, their judgment was liable to become over-confident, if not arrogant. This may have been fueled by the a business ethos that celebrates executives and managers, and their administrative skills and vision, beyond all else. However, Mr Termeer's success was dependent on the painstaking and often thankless work of physicians and scientists, particularly those who first developed the drug that became Cerezyme, the initial funding of this work by the US National Institutes of Health, and the work by scientists and engineers to develop a practical way to manufacture this drug. Termeer also benefited from the Orphan Drug Act which "allowed companies that brought drugs to market seven years of monopoly sales." Without federal research money, favorable laws, and multiple dedicated scientists, physicians, and engineers, Mr Termeer's administrative skills and vision would have yielded nothing. Nonetheless, it was Mr Termeer who was so richly rewarded. In 2006, Boston Magazine <a href="http://www.bostonmagazine.com/articles/the_50_wealthiest_bostonians/">listed</a> him as among the 50 wealthiest Bostonians, with an estimate worth of $342 million.  The 2008 profile noted "Over the past three years, Termeer has earned more than $50 million in total compensation, and thanks to the performance of Genzyme's stock, his stake in the company is now worth about $260 million."  He was interviewed at his waterfront home in tony Marblehead, Massachusetts.  He skippers his (only) "36-foot Hickley Pilot" which is "docked near the new home he's built outside Kennebunkport [Maine]..." the town in which former US President George HW Bush keeps a summer home.  The US (and global) health care business culture disproportionately rewards managers and executives for "innovation," as opposed to the scientists and professionals who actually developed the innovation, or the other people whose money funded these efforts.  These leaders are rewarded them sufficiently to make them into a sort of pseudo-aristocracy.  I hypothesize that such rewards make them believe that they have actually done things worthy of them, breeding over-confidence, arrogance, and a sense of entitlement that puts them beyond the usual rules of society.  The result is leadership that may be ignorant of physicians' values, self-interested, and even corrupt, and health care that is too expensive, inaccessible, and that fails to deliver quality and value commensurate with its cost.  To truly reform health care, we need to reform how health care oganizations' culture and leadership.

What is the "Worst Biotech CEO" Worth?

Recently, we posted about misadventures of the leadership of biotechnology giant Genzyme. Although the company has long priced its drug Ce...

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No Free Speech for Comparative Effectiveness Researchers?

We have repeatedly argued why comparative effectiveness research, under ideal circumstances, would be a good idea.  As I <a href="http://hcrenewal.blogspot.com/2007/09/comparative-effectiveness-kerfuffle.html">said before</a>: <blockquote>Physicians spend a lot of time trying to figure out the best treatments for particular patients' problems. Doing so is often hard. In many situations, there are many plausible treatments, but the trick is picking the one most likely to do the most good and least harm for a particular patient. Ideally, this is where evidence based medicine comes in. But the biggest problem with using the EBM approach is that often the best available evidence does not help much. In particular, for many clinical problems, and for many sorts of patients, no one has ever done a good quality study that compares the plausible treatments for those problems and those patients. When the only studies done compared individual treatments to placebos, and when even those were restricted to narrow patient populations unlike those patient usually seen in daily practice, physicians are left juggling oranges, tomatoes, and carburetors. Comparative effectiveness studies are simply studies that compare plausible treatments that could be used for patients with particular problems, and which are designed to be generalizable to the sorts of patients usually seen in practice. As a physician, I welcome such studies, because they may provide very useful information that could help me select the optimal treatments for individual patients. Because I believe that comparative effectiveness studies could be very useful to improve patient care, it upsets me to see this particular kind of clinical study get caught in political, ideological, and economic battles. </blockquote>However, when comparative effectiveness research was proposed as an element of US health care reform, it was attacked as a vehicle for the dreaded rationing of health care (even though in the US health care is already rationed, especially to those without generous insurance or the means to pay for expensive tests and treatments), using arguments based more on emotions, or outright fallacies than on logic and evidence. For example, see our blog posts <a href="http://hcrenewal.blogspot.com/2007/09/over-top-denunciation-of-comparative.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/09/comparative-effectiveness-kerfuffle.html">here</a>, <a href="http://hcrenewal.blogspot.com/2007/10/whose-opinions-did-new-york-times.html">here</a>, and <a href="http://hcrenewal.blogspot.com/2009/02/attack-on-government-funded-comparative.html">here</a>. Those opposed to the sort of comparative effectiveness research I described above then seemingly decided, "if you can't beat 'em, join 'em."  Thus, a provision appeared in a recent version of health care reform legislation proposed in the US Senate for comparative effectiveness research to be sponsored by an "independent" institute whose board of directors would have to include a substantial minority of representatives of industry (that is, drug, biotechnology, device, health insurance corporations, and other corporations as "payers.")  This would seems to be a fairly shameless form of "regulatory capture," that is, an instance in which a government agency whose mission seems to be to improve health care is "captured" by those with vested interests in promoting certain health care products and services.  (See post <a href="http://hcrenewal.blogspot.com/2009/10/who-should-sponsor-comparative.html">here</a>.) My concern has now seemingly gone mainstream, in that it was addressed in a commentary published on-line in the prestigious New England Journal of Medicine.  [Selker HP, Wood AJJ.  Industry influence on comparative-effectiveness research funded through health care reform.  N Engl J Med 2009.  Link <a href="http://healthcarereform.nejm.org/?p=2364&query=home">here</a>.] Selker and Wood addressed the issue of regulatory capture thus. <blockquote>Although most observers agree on the value of funding CER, many are unaware that embedded in the legislation are provisions ceding substantial influence to the medical products industries that have a major interest in the outcomes of such research. The Senate Finance Committee bill mandates the creation of an entirely new private–public research entity and, owing to industry lobbying, guarantees industry three seats on this entity’s 15-member governing board, as well as representation on its methodology committee </blockquote> Note that the situation is worse considering that the insurance industry and other "payers" also have seats on the board. However, Selker and Wood discovered an even more outrageous provision: <blockquote>The Finance Committee bill also includes language requested by industry lobbyists (pages 1138–1139) that threatens to withdraw federal funding for 5 years from any investigator who publishes a report on research funded by the proposed institute that is not within the bounds of and entirely consistent with the evidence.' Determinations regarding such consistency would be made by the newly created research entity, which would have industry involvement both in its governance and in study design. To allow scientists — and their institutions, which receive the support for the conduct of research — to be punished for the publication of work that is not approved by this entity is essentially to cede authority over the dissemination of government-funded research to a body that is at least partially controlled by persons with a potential commercial interest in its outcome. </blockquote> As Selker and Wood noted, it is unprecedented for a US government agency that is meant to sponsor science to be empowered to punish researchers for conclusions or opinions with which the agency disagrees. This suggests that the new agency would be meant to produce only results that support the vested interests of its leadership, that is, that favor the latest, and most expensive drugs and devices. The research sponsored by such an agency would not only be biased, it would likely be of poor quality, because researchers of integrity would likely avoid sponsorship by an agency that would be so threatening to their scientific independence. This part of the bill does not promote health reform, but blatantly attempts to serve health care corporations while sacrificing the interests of patients and doctors. As Selker and Wood politely put it: <blockquote>If health care reform legislation does not promote CER that is free of the potential taint of commercial and political meddling, the public will have little confidence in the results of such research. This outcome would be extremely unfortunate, since such research has the potential to improve patients’ lives by leading to more effective medical care. The U.S. biomedical research enterprise has a long and storied history that has made it a model for other countries. It would be a tragedy if we were to squander its achievements for political expediency, in the service of short-term commercial interests. The current proposals for controlling CER in a manner unlike anything we have seen in federally sponsored biomedical research therefore should be rejected. </blockquote> It seems to be almost gilding the lilly to note that the provision cited above seems to violate the free speech and free press provisions of the 1st amendment of the US Constitution, since they threaten government punishment of private citizens (e.g., by withdrawal of existing funding) purely for speech that the government does not like. So I ask the anonymous Senate aide who drafted this provision, and the anonymous lobbyist(s) who influenced him or her, have they no shame?  Finally, I have yet to see coverage of the Selker and Wood article in the mainstream media.  I hope they will eventually conclude that this attempt to co-opt clinical science and mock the 1st amendment is actually news and comment worthy.

No Free Speech for Comparative Effectiveness Researchers?

We have repeatedly argued why comparative effectiveness research, under ideal circumstances, would be a good idea. As I said before : Physi...

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Former McKesson CEO and Board Chairman Convicted of Fraud

Continuing with our annals of health care crime, Bloomberg.com <a href="http://www.bloomberg.com/apps/news?pid=20601103&sid=aU0Sd1_0uEjk">reported</a> a new verdict on a very old case: <blockquote>Former McKesson Corp. Chairman Charles McCall was convicted in a second trial of participating in a fraud 10 years ago that cost investors $8.6 billion, one of the largest white-collar crimes at the time. A federal jury in San Francisco yesterday found McCall guilty of five of six counts of securities fraud and circumventing accounting rules. He was acquitted of falsifying records. Sentencing is set for March 2. Ex-McKesson General Counsel Jay Lapine was found not guilty of three charges. McCall and Lapine were accused of hiding backdated sales contracts from auditors and other conduct that improperly inflated revenue figures at San Francisco-based McKesson, the biggest U.S. drug distributor, and HBO & Co., a software maker led by McCall that was acquired by McKesson in 1999. The McCall verdict was a victory for prosecutors who lost a 2006 trial of the ex-chairman. Assistant U.S. Attorney David Anderson told jurors in the three-week trial that McCall learned of the practices a few months before HBO was to be acquired. Instead of blowing the whistle, McCall covered up the fraud and was named chairman of the merged company, Anderson said. When McKesson disclosed in April 1999 that sales had been prematurely booked, leading to a restatement, the shares lost 47 percent of their value. McCall and Lapine were fired that year. A federal investigation followed, and five former McKesson executives pleaded guilty. McCall and Lapine were indicted in 2003. McKesson, which wasn’t named in the U.S. criminal cases, agreed to pay $960 million in 2005 to settle investor lawsuits. </blockquote> On Health Care Renewal, we often seem to get caught up in the details of the moment. This case is a reminder that the problems we have been discussing have been going on for a long time, certainly long before we started to use the new-fangled medium of a blog to write about them. The case also is a rare example of health care leaders actually suffering negative consequences for bad behavior.  We have noted many examples (see some <a href="http://hcrenewal.blogspot.com/search/label/legal%20settlements">here</a>) in which bad behavior by health care organizations results only in a penalty for the organization as a whole, whose impact may be diffused among employees, stock-holders, and customers or clients.  Those who authorized, directed, or implemented the behavior often suffer no negative consequences.  In the current case, some of the responsible leaders have already paid a penalty, and now the most senior responsible leader also appears to be on the verge of also paying a penalty.  On the other hand, it took 10 years from the time the bad behavior was recognized for the penalty to be decided.  Meanwhile, Mr McCall likely continued to enjoy the wealth he had amassed in his position of leadership.  The <a href="http://www.sec.gov/Archives/edgar/data/927653/0000929624-99-001275.txt">1999 McKesson HBOC proxy statement</a>, which included a statement that McCall was forced to resign his positions as Chairman of the Board and employee, noted that Mr McCall had already received a salary and bonus of greater than $2 million (in 1999 dollars) that year, and was the proud possessor of 2,879,677 shares of common stock, more than 1% of shares outstanding, after his resignation.  I say again, meaningful health care reform is unlikely unless we deal with the problem of conflicted, unethical, and sometimes corrupt leadership of health care organizations.

Former McKesson CEO and Board Chairman Convicted of Fraud

Continuing with our annals of health care crime, Bloomberg.com reported a new verdict on a very old case: Former McKesson Corp. Chairman Ch...

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