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Acta Bioethica 2009; 15 (2): 165-171 FINANCIAL AND NON-FINANCIAL CONFLICTS OF INTERESTS
Abstract: A conflict of interests occurs when a doctor is unduly influenced by a secondary interest (i.e., a personal incentive) in his acts
concerning one of the primary interests to which he is professionally committed (the welfare of patients, the progress of science or the education of students or residents). One specific variety of conflicts of interests has monopolized the attention of the scientific and lay press: the financial conflicts of interests arising from the relationships between doctors and drug companies. A large literature has described the many, sometimes subtle, ways by which a psychiatrist can be influenced in his prescribing habits or research activities by his relationships with the industry. Some empirical evidence is now available in this area. On the other hand, it has been pointed out that the current debate on this issue is sometimes "affectively charged", or fails to take into account that the interests of patients, families and mental health professionals and those of the industry may be often convergent. Other types of conflicts of interests are beginning now to be discussed. There is evidence that the allegiance of a researcher to a given school of thought may influence the results of studies comparing different psychotherapeutic techniques, thus colliding with the primary interest represented by the progress of science. Political commitment is also emerging as a source of conflicts of interests. Financial and non-financial conflicts of interests are widespread in psychiatric practice and research. They cannot be eradicated, but must be managed more effectively than is currently the case. Key words: conflicts of interests, pharmaceutical industry, publication bias, disclosure, allegiance effect, political commitment
CONFLICTOS DE INTERESES FINANCIEROS Y NO FINANCIEROS EN PSIQUIATRÍA
Resumen: Se produce un conflicto de intereses cuando un médico se siente indebidamente influenciado por un interés secundario (i.e., un
incentivo personal) en relación con sus deberes primarios con los cuales está comprometido profesionalmente (el bienestar de los pacientes, el progreso de la ciencia o la educación de los estudiantes o residentes). Una variedad específica de conflictos de intereses ha monopolizado la atención de la prensa científica así como de la no especializada: los conflictos de intereses financieros que surgen de la relación entre médicos y compañías farmacéuticas. Una extensa literatura ha descrito las variadas maneras, a veces sutiles, por medio de las cuales un psiquiatra puede ser influenciado por sus relaciones con la industria al aconsejar hábitos, o en sus actividades de investigación. Hoy en día se puede obtener algo de evidencia empírica en esta área. Por otra parte, se ha señalado que, a veces, el actual debate sobre esta materia se ve "cargado afectivamente" o falla en considerar que los intereses de los pacientes, de sus familias y de los profesionales de la salud mental y los de la industria podrían converger. Actualmente, se está empezando a discutir acerca de otros conflictos de intereses. Existe evidencia de que la cercanía de un investigador a alguna línea de pensamiento puede influenciar los resultados de estudios al comparar diferentes técnicas psicoterapéuticas, chocando, por tanto, con el interés primario representado por el progreso de la ciencia. El compromiso político también está emergiendo como fuente de conflictos de intereses. Conflictos de intereses financieros y no financieros están muy esparcidos en la práctica y la investigación psiquiátricas. No pueden ser erradicados, pero deben ser tratados con mayor eficacia de la que se observa hoy en día.
Palabras clave: conflictos de intereses, industria farmacéutica, sesgo de la publicación, desvelar, efecto de lealtad, compromiso político
CONFLITOS DE INTERESSES FINANCEIROS E NÃO FINANCEIROS EM PSIQUIATRIA
Resumo: Ocorre conflito de interesses quando um médico se sente indevidamente influenciado por um interesse secundário (i.e., um incentivo
pessoal) em relação aos seus deveres primários, com os quais está comprometido profissionalmente (o bem-estar dos pacientes, o progresso da ciência, a educação dos estudantes ou residentes). Uma variedade específica de conflitos de interesses tem monopolizado a atenção da literatura científica, assim como da não especializada: os conflitos de interesses financeiros que surgem da relação entre médicos e companhias farmacêuticas. Uma extensa literatura tem descrito as variadas maneiras, às vezes sutis, nas quais um psiquiatra pode ser influenciado devido às suas relações com a indústria ao aconselhar hábitos, ou em suas atividades de pesquisa. Hoje em dia, pode-se obter alguma evidência empírica nesta área. Por outra parte, tem-se assinalado que, às vezes, o atual debate sobre esta matéria se vê "carregado afetivamente" ou falha ao considerar que os interesses dos pacientes, de suas famílias, dos profissionais da saúde mental e os da indústria poderiam convergir. Atualmente, está se iniciando a discussão sobre outros conflitos de interesses. Existe evidência de que a proximidade de um pesquisador com alguma linha de pensamento pode influenciar os resultados de estudos ao comparar diferentes técnicas psicoterapêuticas, conflitando, portanto, com o interesse primário representado pelo progresso da ciência. O compromisso político também está emergindo como fonte de conflitos de interesses. Conflitos de interesses financeiros e não financeiros estão muito difundidos na prática e na pesquisa psiquiátricas. Não podem ser erradicados, porém devem ser tratados com maior eficácia em relação ao que se observa hoje em dia.
Palavras-chave: conflitos de interesses, indústria farmacêutica, obliquidade da publicação, cuidar, efeito de lealdade, compromisso
político
* Department of Psychiatry, University of Naples SUN, Naples. Italy ACTA 2 2009.indd 165 Financial and non-financial conflicts of interests in psychiatry - Mario Maj A conflict of interests occurs when a doctor is unduly exists in a given situation means that the situation is influenced by a secondary interest (i.e., by a personal such that any well-intentioned person might be subtly incentive) in his acts concerning one of the primary in- terests to which he is professionally committed(1-3).
Also, a potential conflict of interests may be more or less The primary interests to which a doctor is professionally substantial. Being a regular consultant or in the board committed are: first of all, the welfare of his patients; of directors of a drug company is not the same thing as then, if he is a researcher, the progress of science; and, eating a pizza at an industry-sponsored lunch(6).
if he is a scholar, the education of his students, residents or colleagues(1-3). It is also important to clarify that a conflict of interests may or not be perceived as such by the involved person. A conflict may also arise between two of these primary Actually, it is common for people to believe that they interests. For instance, between the welfare of an indi- are invulnerable to influences to which they believe vidual patient and the progress of science. This conflict others are susceptible(7). has been covered in the literature, and usually referred to as the "clinician-scientist dilemma". The expression Financial conflicts of interests arising from
"conflict of interests" is not used in this case. Further- relationships to drug companies
more, a doctor may have other professional roles in addition to those of clinician, scientist and scholar. For Of the universe of conflicts of interests which may oc- instance, he may act as a consultant to the judiciary cur in medical (and psychiatric) research and practice, system or to the government. This may be a source of one specific variety has monopolized the attention conflicts. This issue has been covered in the literature of the scientific and lay press: the financial conflicts concerning the practice of forensic psychiatry, where of interests arising from the relationships between there is often a potential conflict between the welfare physicians and drug companies. Much has been said of individual patients and the mandate the psychiatrist and much has been written on this issue. Let us focus receives from the court(4). This conflict, however, is on the points which are currently supported by some rarely referred to as a conflict of interests. The expres- empirical evidence.
sion "dual commitment" or "dual loyalty" conflict is It is to some extent documented that accepting funds more frequently used. for travel and accommodation on the occasion of The expression "conflict of interests" is commonly sponsored symposia is associated with an increased used, instead, when a conflict arises between one of the prescription of the sponsor's medications, and that above-mentioned primary interests to which a doctor physicians who use to request the addition of drugs is professionally committed and one of several possible to their hospital formulary are more likely to have ac- secondary interests (i.e. personal incentives). These cepted money from drug companies(8).
secondary interests include: a) the motivation to obtain It is also documented that studies sponsored by the a financial gain for oneself or an institution (such as a industry are more likely to report outcomes favourable hospital or a university department); b) the motivation to the sponsor's product(9). A systematic review(10) to obtain personal recognition, career advancement found that in 90% of head-to-head comparison stud- or visibility in the media (the so-called academic cur- ies of second-generation antipsychotics the reported rency); c) the motivation to favour a relative, a friend overall outcome was in favour of the sponsor's drug. or a colleague; d) the allegiance to a school of thought, Another study(11) reported that authors' conflict of a socio-political position or a religious belief(1-3). interests was significantly associated with positive Having a potential conflict of interests, i.e., one which trial outcomes in industry-supported clinical trials in is seen as possibility, is different from having an actual conflict of interests, i.e., one documented as a fact. A Since almost all trials of new medications in the psy- common misunderstanding is that having a potential chiatric field are now funded by a drug company, the conflict of interest means that the individual is neces- suspicion is warranted that recent research evidence sarily doing something wrong or unethical. On the in the field of psychopharmacotherapy is to some contrary, judging that a potential conflict of interests ACTA 2 2009.indd 166 Acta Bioethica 2009; 15 (2) The sources of bias in the design, conduct and data key audiences and get those audiences to take action analysis include(12): a) using a dose of the comparison that benefits your product"; "Putting the science of drug which is outside its standard clinical range; b) medicine to work for you. Preparing and building the altering the usual dosing schedule of that comparison market through professional education"(16). drug; c) using self-serving assessment instruments; d) using misleading statistical analyses; e) picking favour- The main antidote to this situation that our profes- able endpoints and outcome measures a posteriori. sion has been able to develop is disclosure (i.e., the The sources of bias in the report of the results of trials disclosure of potential financial conflicts of interests by include(12): a) selectively emphasizing findings which researchers authoring a scientific paper, contributing to are favourable to the sponsored drug; b) masking the production of clinical guidelines, or presenting at a unfavourable side effects of that drug; c) repeatedly scientific meeting or a CME course). The idea is that, publishing the same data in papers with a different since eradicating or even limiting financial conflicts of first author (so that even meta-analyses and systematic interests is unfeasible, at least the readership of scientific reviews may be misled); d) publishing data in sponsored journals and the audience of scientific meetings should supplements where papers are not peer-reviewed; e) be aware of their existence and of the possibility that the withholding unfavourable results.
evidence presented be consequently biased. However, this antidote has not been very effective up to now. In In addition to this, it has been claimed that eminent fact, while self-reports reveal that more than 33% of researchers with significant financial conflicts of in- senior journal authors have financial ties to funders of terests may exercise their impact on the field also in research, the rate of self-disclosure in journals has been their role of referees or editors of scientific journals, reported to be less than 2%(17). thus creating what have been called "special interest The International Committee of Medical Journal Edi- tors has recently produced "Uniform requirements for The same experts are also the most likely to contribute manuscripts submitted to biomedical journals", stating to the production of clinical guidelines. In fact, a fur- that "when authors submit a manuscript, whether an ther well-documented evidence is that most authors of article or a letter, they are responsible for disclosing clinical practice guidelines have financial relationships all financial and personal relationships that might bias with companies whose drugs are considered in those guidelines. A study showed that 59% of contributors to clinical guidelines had received financial support The crucial point, however, is what happens if some- from the industry. Only 7% of them thought that their body refuses or fails to disclose a relationship with relationship with drug companies had influenced their industry. The consequences of this refusal or failure own recommendations, whereas the percentage of those should be substantial enough to ensure the effective- who thought that their co-authors' recommendations ness of the policy(19). Indeed, some professional as- had been influenced was three times higher(14). sociations have issued statements according to which failure to disclose a financial conflict of interests may A further point which is now to some extent docu- constitute grounds for disciplinary action(20). How- mented is that industry-sponsored CME activities ever, professional associations are usually too remote to are often biased in favour of the sponsor's products, be effective, and it should be the responsibility of local and that physicians attending those activities tend to institutions to establish a peer review committee which prescribe those products more often than competing is really functioning and deals with these issues(19). On drugs(15). In several countries, there are now so-called the other hand, concerns have been also raised about medical education and communication agencies, paid common conflicts of interests of members of institu- by drug companies, which put together the programme tional review boards, who may be inappropriately critic of sponsored CME events, select and pay the speak- of other colleagues due to jealousy over their achieve- ers, and sometimes prepare the speakers' slides(16). ments or different school orientations(21). These agencies are very clear in explaining the purpose of their business to drug companies. These are some Concerning the issue of publication bias, a possible quotes from their advertisements: "Medical education antidote which has been frequently proposed is the is a powerful tool that can deliver your message to creation of a registry in which all new trials are re- ACTA 2 2009.indd 167 Financial and non-financial conflicts of interests in psychiatry - Mario Maj corded when they start. This idea has been recently of the industry may be regarded as convergent(26-28). implemented by the World Health Organization, However, this is not necessarily true, if the new drugs which has launched an International Clinical Trials which are promoted are more expensive and do not Registry Platform, urging research institutions and really bring significant advantages with respect to the companies to register all medical studies that test old ones. Furthermore, the fact that we are necessarily treatments on patients or healthy volunteers(22). The partners does not mean that this partnership should issue of publication policies has been also addressed in not have clear rules, better if agreed upon by both a set of good publication guidelines for pharmaceuti- parties involved. cal industry, produced by a working group including several companies, although a final disclaimer specifies The third argument is that drug companies are today, in that the guidelines may not necessarily represent the many countries, the only accessible source of financial policies of those companies(23).
support for drug trials, the organization of large scien- tific meetings and CME events, so that it is practically unavoidable for a professional who wants to implement Has the issue of financial conflicts of interests
one of those activities to look for the support of the in- been overemphasized in psychiatry?
dustry. This is most probably true. However, again, the Four main arguments have been put forward by those fact that a partnership is unavoidable does not imply who believe that the issue of financial conflicts of inter- that such a partnership should not have rules.
ests arising from the relationships between psychiatrists The fourth argument is that the relationship with drug and drug companies has been overemphasized in the companies is not the only source of financial conflicts field of psychiatry.
of interests for physicians and researchers, although The first argument is that the current debate on fi- it is by large the most visible. This is certainly a good nancial conflicts of interests in the psychiatric field is point. There are indeed financial conflicts of interests sometimes biased by ideological prejudice: "The debate in psychiatric practice and research which do not on this issue may have become so vitriolic in psychiatry involve the pharmaceutical industry. For instance, because it taps into a more profound disagreement public health sponsors usually have an interest to avoid about the role of drugs in psychiatry"(24). A more spending money on the most expensive drugs(25). general critique of capitalism may also be involved: This may affect the conduct and the outcome of the "Is the making of money on the back of drug develop- studies they fund (e.g., comparisons between old- and ment and sales somehow immoral?"(24). Moreover, new-generation drugs), especially if the report of re- an oppositional attitude towards drug companies may sults in line with the public sponsor's interest involves carry professional benefits, including a priority when a better chance for researchers to be funded again by public money is distributed for research(25). This that sponsor.
argument is certainly an interesting one. However, it Another almost unexplored issue is that of financial should not be brought so far as to deny the impact of conflicts of interests related to the practice of managed financial conflicts of interests on the psychiatric field, care(29). Many physicians are currently pressured by especially since this impact is now well documented their administrations to be more "productive" (i.e., to by research evidence. see more patients during working hours) and to use The second argument is that the current focus on the least expensive interventions. This increased pro- financial conflicts of interests arising from the rela- ductivity and use of the cheapest treatments may not tionships between psychiatrists and drug companies be in the best patients' interest. If a financial incentive sometimes fails to take into account the fact that the is involved, which is often the case, a financial conflict pharmaceutical industry is today virtually the only of interests may be generated. source of development of new medications in our field, and that we, our patients and their families do Non-financial conflicts of interests in
need new, more effective, better tolerated and more targeted medications. To a large extent, therefore, our interests, those of patients and their families and those Financial conflicts of interests have attracted a lot of interest in the past few decades. However, they are ACTA 2 2009.indd 168 Acta Bioethica 2009; 15 (2) certainly not the only conflicts of interests affecting tations are often associated with a strong prejudicial research and practice in medicine, and particularly in attitude against the use of medications in psychiatry and the hospitalization of psychiatric patients. This prejudicial attitude may sometimes amount to fanati- An example of non-financial conflict of interests af- cism ("those who prescribe psychotropic drugs are like fecting psychiatric research is given by the possible pushers"; "psychiatry does not need any beds"). conflict between the secondary interest represented by the researcher's allegiance to a given school of thought Of course, everybody is free to hold and profess even and the primary interest represented by the progress extreme ideas, and one could argue that these views of science(3). may sometimes represent a stimulus to the field. How- ever, if a psychiatrist holding such ideas (or, even worse, The impact of this "allegiance effect" on the outcome of a psychiatrist wishing to please a head physician or a psychotherapy research has been repeatedly described. manager holding such ideas) denies pharmacological A systematic review(30) found that the combination treatment and/or hospitalization to a severely depressed of three measures of researcher's allegiance accounted patient, who then commits suicide, isn't this a tragic for 69% of the effect size of treatment outcome in instance of conflict between the secondary interest studies comparing three psychotherapeutic tech- represented by the psychiatrist's political commitment niques. Interestingly, some mechanisms by which the and the primary interest represented by the patient's researcher's allegiance may operate are very similar to welfare?(3). those explaining the impact of financial conflicts of interests on the outcome of drug trials: the selection A prejudicial attitude against the use of medications of a less effective intervention to compare with the in psychiatry may more often manifest itself as the researcher's favoured treatment; the unskilful use of the stubborn refusal to learn to use those medications ad- comparison treatment; a focus on data favouring the equately, and to even consider reading drug treatment preferred treatment in study reports; and the failure to guidelines, because this would mean to acknowledge publish negative data. the essential therapeutic role of something which is instead regarded as an only marginal ingredient of care. The impact of this allegiance effect (along with the fact The consequence of this attitude is that medications are that the proponents of some psychotherapies may for indeed used, but in an irrational and chaotic way, again various reasons be less interested in the scientific valida- with a significant detriment to patients' welfare(3). tion of their techniques) may bias the research evidence concerning the relative efficacy of the various psycho- As I mentioned above, it has been rightly pointed therapies, exactly like the impact of financial conflicts out that there are now in our field "special interest of interests may bias the research evidence concerning groups", consisting of prominent leaders with sig- the relative efficacy of the various psychotropic drugs. nificant financial conflicts of interests (arising from Not surprisingly, it has been argued that "the balance of their relationships to drug companies) who exercise a investigator allegiance across the schizophrenia litera- powerful impact on the field in their various capaci- ture is against psychodynamic or supportive methods ties (e.g., as editors or referees of scientific journals, or and in favour of CBT approaches"(31). contributors to treatment guidelines)(13). One could argue, however, that similar "special interest groups" An example of non-financial conflict of interests af- consisting of prominent leaders with significant ideo- fecting psychiatric practice is given by the possible logical conflicts of interests may also exist. They may conflict between the secondary interest represented by exercise an equally powerful impact on the field acting, a psychiatrist's political commitment and the primary for instance, as contributors to mental health policy interest represented by patients' welfare(3).
guidelines or consultants to governments. Further- In my country, a minister of education stated some more, another emerging circle is that of "two-sided" years ago that a psychiatrist should always be a political experts, eloquently advocating opposite positions (for activist, and, indeed, being a political activist may be instance, in favour or against the use of new-generation very useful to a psychiatrist in fulfilling his professional medications) depending on the context in which they duties. However, it is a fact that some political orien- speak (e.g., a sponsored symposium vs. a meeting of a governmental task force)(3).
ACTA 2 2009.indd 169 Financial and non-financial conflicts of interests in psychiatry - Mario Maj terests are probably both common and significant in Conflicts of interests are widespread in medical, psychiatric practice and research, although currently and psychiatric, practice and research. Financial underemphasized and understudied. conflicts of interests, particularly those arising from Conflicts of interests in psychiatric research and prac- the relationships of physicians and researchers to the tice cannot be eradicated, but must be managed more pharmaceutical industry, have a significant impact on effectively than is currently the case, and this is certainly the psychiatric field, now to some extent documented an area which our professional associations should be by research. However, non-financial conflicts of in- more active in the future.
References
1. Thompson DF. Understanding financial conflicts of interest. N Engl J Med 1993; 329: 573-576.
2. Maj M. Conflicts of interests in psychiatric practice and research. Psychiatrie 2005; 3: 138-140.
3. Maj M. Non-financial conflicts of interests in psychiatric research and practice (Editorial). Br J Psychiatry 2008; 193:
4. Sen P, Gordon H, Adshead G, Irons A. Ethical dilemmas in forensic psychiatry: two illustrative cases. J Med Ethics 2007; 33: 337-341.
5. Warner TD, Gluck JP. What do we really know about conflicts of interest in biomedical research? Psychopharmacology 2003; 171: 36-46.
6. Fava GA. Financial conflicts of interest in psychiatry. World Psychiatry 2007; 6: 19-24.
7. Cialdini RB, Trost MR. Influence, social norms, conformity, and compliance. In: Gilbert DT, Fiske ST, Lindzey G, (eds.) The handbook of social psychology, 4th ed. New York: Oxford University Press, 1998.
8. Wazana A. Physicians and the pharmaceutical industry. Is a gift ever just a gift? JAMA 2000; 283: 373-380.
9. Lexchin J, Bero LA, Djulbegovic B, Clarke O. Pharmaceutical industry sponsorship and research outcome and quality: systematic review. BMJ 2003; 326: 1167-1170.
10. Heres S, Davis J, Maino K, Jetzinger E, Kissling W, Leucht S. Why olanzapine beats risperidone, risperidone beats quetiapine, and quetiapine beats olanzapine: an exploratory analysis of head-to-head comparison studies of second- generation antipsychotics. Am J Psychiatry 2006; 163: 185-194.
11. Perlis RG, Perlis CS, Wu Y, Hwang C, Joseph M, Nierenberg AA. Industry sponsorship and financial conflict of interest in the reporting of clinical trials in psychiatry. Am J Psychiatry 2005; 162: 1957-1960.
12. Safer DJ. Design and reporting modifications in industry-sponsored comparative psychopharmacology trials. J Nerv Ment Dis 2002; 190: 583-592.
13. Fava GA. Conflict of interest and special interest groups. Psychother Psychosom 2001; 70: 1-5.
14. Choudhry NK, Stelfox HT, Detsky AS. Relationships between authors of clinical practice guidelines and the pharmaceutical industry. JAMA 2002; 287: 612-617.
15. Relman AS. Separating continuing medical education from pharmaceutical marketing. JAMA 2001; 285: 2009- 16. Ross JS, Lurie P, Wolfe SM. Medical education services suppliers: a threat to physician education. Washington: Public Citizen's Health Research Group; 2000.
17. Hussain A, Smith R. Declaring financial competing interests: survey of five general medical journals. BMJ 2001; 323: 18. International Committee of Medical Journals Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Available at www.icmje.org/index.html. 19. Foster RS. Conflicts of interest: recognition, disclosure, and management. J Am Coll Surg 2003; 196: 505-517.
20. American College of Surgeons. Statements on principles, 1987. Available at www.org/fellows_info/statements/stonprin.
21. Francis L. IRBs and conflicts of interest. In: Spece RG, Shimm DS, Buchanan AE, (eds.) Conflicts of interest in clinical practice and research. New York: Oxford University Press, 1996.
22. World Health Organization. International clinical trials registry platform. Geneva: World Health Organization; 2006.
ACTA 2 2009.indd 170 Acta Bioethica 2009; 15 (2) 23. Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin 2003; 19: 149-154.
24. Goodwin G. Conflicting interests and doing right. World Psychiatry 2007; 6: 25-26. 25. Vieta E. Psychiatry: from interest in conflicts to conflicts of interest. World Psychiatry 2007; 6: 27-29.
26. Thase ME. On the property of collaborations between academicians and the pharmaceutical industry: an alternate viewpoint. World Psychiatry 2007; 6: 29-31.
27. Paul SM, Tohen M. Conflicts of interests and the credibility of psychiatric research. World Psychiatry 2007; 6: 33-34.
28. Nierenberg AA. A counter proposal to manage financial conflicts of interests in academic psychiatry. World Psychiatry 2007; 6: 34-36.
29. Rodwin MA. Medicine, money, and morals: physicians' conflicts of interest. New York: Oxford University Press; 1993.
30. Luborsky L, Diguer L, Seligman DA, Rosenthal R, Krause ED, Johnson S, Halperin G, Bishop M, Berman JS, Schweizer E. The researcher's own therapy allegiance: a "wild card" in comparisons of treatment efficacy. Clin Psychol: Sci Pract 1999; 6: 95-106.
31. Paley G, Shapiro DA. Lessons from psychotherapy research for psychological interventions for people with schizophrenia. Psychology and Psychotherapy: Theory, Research and Practice 2002; 75: 5-17.
Recibido: 3 de julio de 2009 Aceptado: 28 de julio de 2009 ACTA 2 2009.indd 171

Source: http://www.revistas.uchile.cl/index.php/AB/article/download/15726/16197