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Jemh_vol4_no1_sept supp_privatization_of_knowledge_and_creation_of biomedical_conflicts_of_interest_apr09.inddPrivatization of Knowledge and the Creation of
Biomedical Conflicts of Interest
Leemon B. McHenry
Department of Philosophy, California State University, Northridge
Jon N. Jureidini
Discipline of Psychiatry, University of Adelaide, South Australia
rather than to what is meaningful, so that fi ndings that are Abstract
likely to be clinical and meaningful are rejected because they fail to reach statistical signifi cance whereas others that appear Scientifi c and ethical misconduct have increased at an clinically trivial are accepted (Ziliak and McCloskey, 2007). Th alarming rate as a result of the privatization of knowledge. disenchantment with the psychoanalytic paradigm of psychiatry What began as an eff ort to stimulate entrepreneurship led to a massive investment in psychopharmacology and other and increase discovery in biomedical research by physical interventions. A concession now to the limited benefi t strengthening the ties between industry and academics that psychopharmacology off ers would come at great cost to the has led to an erosion of confi dence in the reporting of profession. A vested interest in protecting the new paradigm of research results. Inherent tensions between profi t-directed neurological models of psychiatric disorders reaches beyond the inquiry and knowledge-directed inquiry are instantiated quest for a secure scientifi c foundation.
in psychopharmacology, especially in the co-option of academic activity to corporate objectives. The eff ects of To the vulnerability created by personal bias and questionable these tensions are visible in research agendas, publication methodology we must add the dangers of pervasive fi nancial practices, postgraduate education, academic-industry confl icts of interest, of which we investigate the root cause in this paper. With the privatization of knowledge comes a heavy burden of untangling the motives of profi t from the motives of scientifi c objectivity. Confl ict of interest has created an epistemological Key Words: confl icts of interest, ethics, intellectual property
morass and a serious problem of credibility for the profession law, key opinion leaders, knowledge-directed inquiry, e bias created from researchers’ interests and pharmaceutrical industry, privatization, profi t-directed inquiry ambitions pales in comparison to bias due to the now pervasive infl uence of industry. I n t r o d u c t i o n
P r o f i t - D i r e c t e d I n q u i r y vs .
K n o w l e d g e - D i r e c t e d I n q u i r y
here are many pressures that potentially undermine the disinterested status of an academic scientist. None are free of bias. We carry pre-conceptions and expectations It is in industry’s interests to be competitive, protect discoveries and into research yet rely on research methodology to counter these strategies as trade secrets, demand product loyalty, and suppress eff ects. Most at risk are those who fail to acknowledge bias. In criticism, all to the end of gaining market share and maximizing disciplines where research involves measurement, we rely on profi t. As such, inquiry is profi t directed. By contrast, academe developing objective measures so that outcomes are less susceptible is a cooperative enterprise, characterized by free, open critical to researchers’ judgments. Medical scientists are doubly vulnerable inquiry and disinterest in the results of research in the pursuit of and may need a greater level of protection from bias than many truth and discovery of error. Richard Horton citing the American ey are also likely to be infl uenced by their historian Steven Shapin, contends that the two cultures of the idiosyncratic experience with their own patients. scientifi c and trading classes, or what we identity as the knowledge vs. profi t inquiry, were kept separate, to protect the integrity and Psychiatry may be the branch of medicine that is most vulnerable virtues of the former from the vices of the latter. Scientists were, and are still meant to be, trusted to produce a reliable body of Given the ascendancy of what Ziliak and McCloskey call the “cult knowledge, while no such requirement is supposed from those of statistical signifi cance,” researchers turn to what is measurable who seek private advantage (Horton, 2004, 7).
JEMH · April 2009 · 4(Sept. Suppl.) | 1 2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)
A marriage of these two very diff erent cultures or motives has opinions of someone who is not sympathetic to its product. Few produced a situation in which the profi t motive threatens the physicians and psychiatrists can resist the lure of fame and fortune ideal of intellectual inquiry. Addressing the most important needs off ered by industry, but the primary motive of ethical duties to of humanity becomes subservient to the pursuit of signifi cant patients is compromised by profi table drug and medical device revenue. But more importantly for our present concern, profi t promotion; marketing directives threaten the accuracy of research inquiry instantiated in the corporate model of the academy results and university professors become what David Healy calls has resulted in an alarming increase in scientifi c and ethical “ornamental additions to business” (Healy, 2004, xv).
misconduct, especially in biomedical research. Th that the industry-academe dichotomy has been sharply drawn e rise of the KOL and academic entrepreneur coincides with and immune from contamination until recently, but in our what is arguably one of the most infl uential pieces of legislation to view what might have been well-intentioned legislation to spur impact the fi eld of intellectual property law—the Bayh-Dole Act of entrepreneurship in the commercial development of research has 1980. Such legislation was explicitly designed for the privatization accelerated the confl icts of interest and the resulting misconduct of knowledge during Reagan Revolution in the United States, and with virtually no regulatory oversight. In fact, the political motives resulted from a shift in the philosophy of government from creating that created the acceleration of confl icts of interest are the very public wealth and safety nets for the less fortunate to maximizing same ones that have considerably weakened regulation—all as a private, for-profi t sections (Krimsky, 2004, 108). by apologists, will correct product defects and expose corruption. e Bayh-Dole Act created a uniform patent policy that allowed Yet the harm to public health that has resulted from distortion in universities to retain ownership to inventions made under clinical research and the use of that research in drug promotion federally-funded research. Previously the federal government has made it clear that the marketplace is too slow or inept when assumed ownership of the research it funded but it did not have the resources to expedite transfer of technology for commercial development. Moreover, when the government granted non-exclusive licenses to businesses, competitors could acquire the Th e P r i v a t i z a t i o n o f K n o w l e d g e a n d
same licenses and thus there was little incentive to enter into such Co n f l i c t o f I n t e r e s t
e motivation behind Bayh-Dole was to speed up the commercialization process of federally-funded research, create new industries and open new markets from the university- Confl ict of interest is defi ned as a problem of competing motives. patented inventions. Robert Kelch reports that: “since 1980, at A confl ict of interest exists when one in a position of trust has least 2900 companies have been formed that were built around competing professional or personal interests which make it diffi an innovation licensed by researchers at an academic institution” to fulfi ll his or her duties impartially. We take as a case study the United States pharmaceutical industry (by far the world’s biggest), and its relationship with Key Opinion Leaders (KOLs), particularly e growth of university patents and the commercialization of psychiatrists who are amongst those most generously supported by research that followed Bayh-Dole at fi rst seemed to have nothing pharma (Sorrell, 2008). In medicine, the phenomenon of the KOL but positive eff ects, such as the innovations in the development is a result of the industry-academic partnership that has become of biotechnology and rapid development of pharmaceuticals, but virtually synonymous with fi nancial confl ict of interest. KOL’s are it soon became clear that the legislation had opened a Pandora’s individuals who act as consultants, researchers and teachers for Box. Universities that were losing government funding found the e relationship is mutually benefi cial to the new source of revenue in the technology transfer to industry, but KOLs and the companies but not necessarily to patients. For the at the price of a proliferation of confl icts of interest. It increased company, it provides an apparently independent expert to publish consulting arrangements with greater emphasis on intellectual and speak on behalf of its products. For the academic, it off ers property (Krimsky, 2006, 22) and created a culture of secrecy that kudos, research income, publications (including invitations to “may actually have slowed the sharing of scientifi c information co-author infl uential papers that are largely ghost-written) and a and the exploration of new scientifi c leads” (Angell, 2004, 203). profi le at major congresses. It also off ers great fi nancial benefi t. e most disturbing aspect of these arrangements, however, is the As the inquiries of US Senator Charles Grassley have revealed, manipulation of research results in favor of the sponsor company’s senior KOLs have failed to disclose the extent of their fi nancial entanglements with industry (Grassley, 2008). We can only guess at the degree of infl uence this undeclared income has had on their e secrecy involved in privatization created another obstacle practice, but even absent any fi nancial irregularities, KOLs are to scientifi c progress since a signifi cant portion of industry subject to infl uence through the benefi t to their academic careers. misconduct in clinical research is protected under the intellectual property law called “the Uniform Trade Secrets Act.” Th Pharmaceutical companies take considerable eff ort in recruiting legislation prevents release of important information on the basis KOLs they identify as malleable to their purpose by carefully of the alleged necessity of protecting commercial interests that monitoring a potential KOLs’ prescribing and research. A young academic might be supported in research or asked to teach. If the company likes what it hears, its investment in the KOL will Pharmaceutical companies under challenge by legal proceedings to e KOLs need never feel that they are being infl uenced release information to the public routinely claim protection under the aegis of trade secrets. While some documents are unsealed existing conducive attitudes rather than attempt to change the and released to the public because they are already in the hands of JEMH · April 2009 · 4(Sept. Suppl.) | 2 2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)
a third party such as a peer-reviewed journal or a Public Relations from negative trials (Ross et al, 2008, Steinman et al, 2006). Others agency, the majority of critical documents remain unknown to the such as drotrecogin alfa (Xigris) and aprotinin (Trasylol) reveal further instances of manipulation of data and marketing hype that reveal exploitation of academics or physicians for marketing (Singh and Singh, 2007a, 2007b). Indeed as Krimsky reports, and promotion purposes, budgets that include payments to KOLs this is just the proverbial tip of the iceberg since the majority of and medical communication companies that have produced cases remain undisclosed (Krimsky, 2004, 9). Industry-sponsored ghostwritten publications, advisory board and speakers’ symposia trials conducted by academic investigators are prime examples of members, marketing agendas that describe manipulation of the the harm done to the reputation of clinical research in the wake peer-reviewed medical journals, programs designed to increase e paper that reported study 329, for example, patient compliance, secret liaisons with patient support groups, claimed that: “paroxetine is generally well tolerated and eff ective disease mongering, and the results of negative clinical trials. Only for major depression in adolescents” (Keller et al, 2001). Yet occasionally does anything of this sort see the light of day and documents obtained during litigation reveal that study 329 was only because of attorneys’ errors in submitting documents to the cacy on all eight protocol specifi ed outcomes and court or because an industry insider has smuggled documents by removing four of the eight negative outcome measures specifi ed uses of the Trade Secrets Act such as protecting discoveries of new in the protocol and replacing them in the published paper with molecular entities from industrial espionage, but the abuse of the positive ones (two of which were introduced aft er breaking the Act in order to protect companies from discovery of misconduct blind), and by confl ating measures to give the false impression that and fraud only adds to the general problem that privatization has one of the primary outcomes was positive (Jureidini et al, 2008). created for the attempt at reliable science.
Harms were either not reported or glossed over.
When the Keller et al paper was published, paroxetine was Th e Co n s e q u e n ce s o f P r i v a t i z a t i o n i n
vigorously promoted to SKB/GSK sales representatives as M e d i c a l R e s e a r c h
treatment of adolescent depression” (Hawkins, 2001), and the same message was delivered to the psychiatric community by Sheldon Krimsky has documented well the misconduct that KOLs, who frequently did not disclose the results for the primary has resulted from the academic-industry alliance that makes outcomes and serious adverse events (see, for example, Keller 1998, knowledge the property of for-profi t companies (Krimsky, 2003). Berard et al, 1998, Wagner et al, 1998, Gagiono, 1999, Wagner, We wish to expand Krimsky’s thesis with further evidence of 2003). Reprints of the Keller et al paper were distributed by GSK the destructive consequences of ownership of data and industry with Med Query Letters to physicians.
A whole industry has developed as a result of privatization called As mentioned above, the most serious consequence of the “medical communications.” At last count, there were close to 200 privatization of knowledge concerns the reporting of results from such companies in the United States alone (Golden et al, 2002). industry-sponsored clinical trials. When academic investigators ese fi rms have been identifi ed as a major source of facilitating enter into a contact with a pharmaceutical company, they will sign misrepresentation in journal publications and in conference a confi dentiality agreement that makes it clear from the outset posters which they prepare for industry. For a modest fee, the that the data produced in the trial is the property of the sponsor drug company can retain control of the message via the medical company and that any publication of results must be approved by communication company it hires, reward KOLs with publication company. In fact, before any publication appears the company and thereby ensure that there is little risk that the named authors signs off on release of the results to the named lead author thereby will take control of the message communicated through the transferring ownership of the paper. Physician-investigators who paper. Study 329 was fi rst draft ed and then revised by a medical have signed such contacts and then discovered in the course of communications company, and there were very few meaningful the trial that the drug they were testing presented a serious danger changes (and therefore little scope for contribution by the named to public health have found themselves in an ethical dilemma: authors) from that fi rst draft to the published paper (McHenry either remain silent and violate the primary obligation to patients’ health, or reveal the danger, face legal action and the destruction of their careers. Th e cases of Nancy Olivieri, Betty Dong, Aubrey Commercialization of science results in distorted priorities in Blumsohn and John Buse are particularly noteworthy in this research. Rush to blockbuster status for relatively trivial medical connection because in their choice to reveal the danger, the sponsor problems or disease-mongered creations for consumers in fi rst- companies sought retaliation. (Schafer, 2004, Krimsky, 2004, Baty, world countries dominate the research agenda rather than the development of medicines for more serious problems throughout the world. Of 1393 new chemical entities marketed between 1975 In 2006 we were asked by the Baum-Hedlund law fi rm to do an and 1999, only 16 were for tropical diseases and tuberculosis independent analysis of study 329, sponsored by GlaxoSmithKline, (Trouiller et al, 2002). Marcia Angell exposes the main business on paroxetine (Paxil, Seroxat) use in adolescents. While it might of the pharmaceutical industry as the development of “me-too” seem hasty to extrapolate from this one trial, similar trials drugs, namely, minor changes in the molecule of a blockbuster conducted on rofecoxib (Vioxx) and gabapentin (Neurontin) have drug that is just diff erent enough to qualify for a new patient shown a pattern whereby the sponsor companies working with (Angell, 2004, 76). So, drugs that treat heartburn, obesity, hair medical communication companies have spun positive results loss, toenail fungus, sexual performance, depression, allergies, JEMH · April 2009 · 4(Sept. Suppl.) | 3 2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)
high cholesterol, and the like will have a high priority in the being, while in academe it serves a vital function in the pursuit company while other important drugs that are less profi table will of truth. Pharmaceutical marketing objectives identify academic not be developed or will be discontinued. Examples of this latter physicians as hostile adversaries of their drugs and seek strategies group include certain anesthetics, antivenins, antidotes for drug to ‘neutralize’ their criticism. One manner of accomplishing this overdoses, anticlotting drugs, antibiotics, and vaccines against objective is by alleging that doctors with concerns about effi fl u and pneumonia, many of which are lifesaving treatments, but and safety are secretly promoting competitors’ drugs (Coyne, which have lesser appeal to industry because they are short-term 2005). Another is the co-option of KOLs to sign on to ghostwritten rather than life-long treatments, or they treat diseases of the poor. letters to the editors that defend the drugs against criticism. Th An investigation into the development of HIV/AIDS drugs reveals tactic creates the appearance of academic discourse, but in reality that the real source of success was not profi t-inquiry via KOL is nothing more than exploitation of the medical journals by development, but rather liaisons between government, universities pharmaceutical marketing (McHenry, 2005). and other non-profi t research before the compounds were shift ed to private drug companies for further development, manufacture All of the above has led to an erosion of confi dence both in the and distribution (Angell, 2004, 25-27, 67-68).
wider medical community for the integrity of medical research and reporting of such research and in the public perception of e industry-academe alliance has stifl ed academic freedom and critical inquiry. As Fava has made the point: “Investigators who swim against the tide of corporate-driven research strategies may indeed have diffi culty in publishing their fi ndings and Co n c l u s i o n
observations” (Fava, 2004, 2). Commercial interests have come to dominate the content of academic medical journals. Advertising and reprint revenue alone raise serious questions about the degree e profi t vs. knowledge-directed inquiry distinction can be to which such journals can claim to be neutral arbiters in the a false dichotomy if indeed profi t and knowledge motivations attempt to produce a reliable body of knowledge (Lexchin and merge to produce excellent scientifi c results and much needed Light, 2006). What has become known as “commercially valuable e evidence of the past twenty-eight years since content,” allegedly good news about medical breakthroughs in Bayh-Dole in the United States, however, suggests otherwise. pharmaceuticals and medical devices much to the advantage of While the short-term stimulus to biomedical research has been the industry, has higher priority over bad news resulting from much celebrated, the unintended, long-term consequences for critical studies about manipulated results or ineff ective and unsafe medicine have been severe. Scientifi c progress is thwarted by the medicine. No advertising contracts or profi table reprint orders ownership of knowledge, especially in clinical medicine where the follow the publication of a study that demonstrates the failure of adverse impact has reached an unprecedented crisis point (Fava, clinical trial. Few journal editors seem to realize the degree to 2006). When the profi t motive dominates research agendas, there which they have been infi ltrated by pharmaceutical marketing and is relatively little confi dence in the results. Th the strategy of the latter to use the journals as vehicles of promotion. the medical community was summed up in a response to Angell’s Richard Horton, in this connection argues that: “Medical journals e New England Journal of Medicine, “Is Academic have become an important but underrecognized obstacle to Medicine for Sale?” with the quip, “No. Th scientifi c truth” since they “have devolved into information happy with it” (Ruane, 2000). Competition in industry prevents laundering operations for the pharmaceutical industry” (Horton, cooperative research and open, critical evaluation essential to privatization of knowledge is the only source of confl ict of interest Finally, instead of following the results of peer review, there in medicine, but there is little doubt that it has accelerated such is much evidence that the fi nal decision to publish is made by confl icts since the 1980s. When knowledge, and especially that of legal counsel to the journals. Papers that expose the extent of critical concern to public health, becomes the private property of scientifi c misconduct and manipulation of trial results in industry- industry and academics are co-opted for the purpose of advancing sponsored studies are routinely rejected due to fear of legal action this interest, the society that enables such activity has lost all claims brought by the companies (Healy, 2008). Our papers on study 329 to participate in the advance of science. (Jureidini et al, 2008; McHenry and Jureidini, 2008) began life as an invited contribution by the editor of the British Medical Journal. It may be impossible for medicine to sever its relations to its Amongst the reasons for her rejection was a “combination of pharmaceutical and medical device industries. Th editorial and legal concerns that we feel are unlikely to be resolved little doubt that restoring confi dence in the profession requires even with a great deal of further work on your part and on the part active protection of its autonomy and integrity. Since it seems is raises an important question about academic highly unlikely that there will be any reversal of legislation that freedom when our journals routinely publish ghostwritten articles led to the problem or competent government regulation, it is the from industry-sponsored clinical research, but then reject critical moral imperative of individual practitioners to eliminate confl ict studies of those same publications on the basis that legal counsel is demands fi rst of all a unifi ed eff ort of psychiatrists to the journals has advised of potential libel actions brought by the and other physicians to resist the relationships with industry that pharmaceutical and medical device industries (McHenry, 2008). have distorted results of clinical research and led to habits of Industry infl uence on the medical journals has thus led to a form of overprescription. Second, the profession must regulate itself by censorship forced on editors. Under the business model, criticism moral censure of practices that are profi t-oriented and ostracize of products or processes is regarded as little more than competitors’ vying for market share and a hostile threat to the company’s well a confi dentiality agreement with a sponsor company can claim JEMH · April 2009 · 4(Sept. Suppl.) | 4 2009 Journal of Ethics in Mental Health (ISSN: 1916-2405)
scientifi c status for the results of the trial. As Wagner and Steinzor make the point: “Science demands that, to the maximum extent Jureidini, J. N., McHenry, L. B., Mansfi eld, P. R. (2008) “Clinical possible, scientists have no stake in the outcome of the research” Trials and Drug Promotion: Selective Reporting of Study 329,” (Wagner and Steinzor, 2006, 6). Rigorous science can only exist International Journal of Risk and Safety in Medicine, 20: 73-81.
when there is a genuine, risky test that could prove the hypothesis Kelch, R. P. (2002) “Maintaining the Public Trust in Clinical Research,” New England Journal of Medicine, 346: 285-87.
the outcome of experiments whether those outcomes are welcome Keller M., Ryan, N.D., Birmaher, B., et al. (1998) “Paroxetine and or not (Ziman, 2000). As we have seen above, industry-sponsored Imipramine in the Treatment of Adolescent Depression,” research seldom if ever meets these criteria.
(Abstract NR562:209). Presentation to American Psychiatric Association, Toronto, 2 June, 1998. http://www.healthyskepticism.
As for Robert Kelch’s dilemma of “how to strike a balance between org/documents/documents/KellerPoster.pdf (accessed October the need for investigators to act in the best interest of patients and their desire to serve the interests of the product they are Keller, M.B., Ryan, N.D., Strober, M., Klein, R.G., Kutcher, S.P., developing” we agree that there is no choice to make (Kelch, 2002, 285). Physicians have a primary ethical duty to patients, not to of Adolescent Major Depression: a Randomized, Controlled Trial,” Journal of the American Academy of Child and Adolescent once the physician enters into an agreement that gives industry Krimsky, S. (2003) Science in the Private Interest, Lanham: Roman Krimsky, S. (2006) “Autonomy, Disinterest, and Entrepreneurial R e f e r e n ce s :
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Leemon McHenry is research consultant for Baum Hedlund law fi rm of Los Angeles, California. Jon Jureidini is engaged by Baum Hedlund to provide an independent analysis of the data in Study 329 and is chair of Healthy Skepticism, an international non-profi t organization with a main aim of countering misleading drug promotion. Address for Correspondence:
Leemon McHenry Department of Philosophy California State University, Northridge 18111 Nordhoff Street Northridge, CA 91330-8253 Email: firstname.lastname@example.org
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List of all Challenge substances This table represents the composition status of the substances in each batch as of the 26 December 2009 launch of Batch 12. The composition of each Challenge batch is confirmed 3 months before it is launched in the Canada Gazette Part 1. Substance Name Challenge Categorization Batch no. Decision Finalized Challenge Batches (as of the