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A New Deal on Disease Definition How Do We Replace the Old Panels of Confl Icted Experts? Ray Moynihan Investigates

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A New Deal on Disease Definition How Do We Replace the Old Panels of Confl Icted Experts? Ray Moynihan Investigates MEDICALISATION bmj.com Theme issue: Too much medicine? (BMJ Vol 324, Issue 7342, 13 April 2002) Feature: Merging of marketing and medical science: female sexual dysfunction (BMJ 2010;341:c5050) Observations: Overdiagnosis and the dange rs of early detection (BMJ 2011;342:d1140) A new deal on disease definition How do we replace the old panels of confl icted experts? Ray Moynihan investigates As this still-fresh century rolls forth, medi- what were until very those who produced cine’s imperial project looks on the whole to recently considered SUMMARY POINTS its fourth edition be in remarkably good health, despite the odd healthy people, and • Many existing panels that define and expand found % of panel failed campaign. With our new found fond- leading voices are diseases are heavily tied to drug companies members had finan- ness for preventing disease and premature asking whether it is • Some voices are calling for fresh new ways to cial ties to drug com- death we’re redefi ning more and more of the time society at large define disease, with new panels panies, although for healthy as sick, and then prescribing our new took a more direct • New panels could be independent of some panels, includ- patients lifelong pharmaceutical solutions to role in deciding who industry and entirely free of conflicts of ing that for mood interest reduce their risks. One recent analysis suggests really warrants a disorders, the figure that the defi nitions of common conditions have medical label. ­ Some • The constitution of new panels could be was %. Despite broadened so much that virtually the entire are now calling for a broadened, more representative, with more a new American citizens’ voices older adult population is now classified as major renovation of Psychiatric Associa- having at least one chronic disease. the way in which we • The best evidence should inform decisions, tion policy aimed at including evidence on social determinants Yet a growing scrutiny of the seemingly well defi ne disease. reducing confl icts, an meaning march of medicalisation suggests analysis of the forth- we may sometimes be pushing boundaries Confl icted panels widen diseases, lower coming fi fth edition found that of those panel too wide, and setting treatment treatment thresholds members who’d made disclosure statements, thresholds so low, that people Among the members of the panel that cre- exactly % had fi nancial relationships with with mild problems or modest ated the controversial diagnostic category pharmaceutical companies. risks are exposed to the harms “pre-hypertension” in ­, received “We’ve got to take this away from the and costs of treatment with money from drug companies, and half of American Psychiatric Association,” said Allen little or no benefi t. It has those people declared extensive ties to more Frances, the psychiatrist who chaired the task- also become clear that than companies each. Critics have rejected force for the fourth edition, the DSM-IV. He now many of the people on “pre-hypertension” as a dangerous pseudo- believes that that edition unwittingly contrib- the panels that are wid- syndrome that could increase drug company uted to an explosion of unnecessary diagnoses ening the patient pool markets, while others point out that it gives in the areas of attention defi cit, autism, and have direct financial a diagnostic label to nearly % of the adult bipolar disorder. Frances argued that it was ties to the companies population of the United States. Similarly, not just fi nancial ties that were important, but benefiting from that of the authors of a statement on intellectual confl icts too, where researchers expansion. Concerns type diabetes were heavily confl icted, with pushed for greater recognition of their own pet are mounting that doc- authors working as consultants, speakers, conditions. tors are collectively or researchers for an average of nine compa- To emphasise this point, he said that he did o v e r d i a g n o s i n g nies each. That panel advocated a conten- not believe a drug industry push was behind millions of tiously low blood sugar target, and explicitly even those decisions that would most benefi t defended the use of rosiglitazone, a drug since the industry. Today he warns that the forth- suspended from the European market because coming DSM-V could unleash multiple new of its hazards to human health. Within the fi eld “false positive epidemics,” where common of sexual dysfunction, confl icts of interest have experiences including binge eating and tem- reached new heights of absurdity, with drug per problems are mistaken for the “symptoms” company employees joining their paid consult- of new disorders. “Experts tend to loathe the Critics have rejected ants to design diagnostic tools to identify and idea of missing a potential patient, and they “pre-hypertension” as a then medicate millions of women with a dis- lack the ability to assess the risks and benefi ts order of low desire that may not even exist. of creating new conditions or widening old dangerous pseudosyndrome One of the best known examples of con- ones,” he explained to the BMJ. “This sort of that could increase drug fl icted panels widening disease defi nitions work should no longer be done by any profes- comes from the Diagnostic and Statistical sional association. A new way to defi ne disease company markets Manual of Mental Disorders. An examination of is needed.” 1054 BMJ | 14 MAY 2011 | VOLUME 342 MEDICALISATION “Experts tend to loathe the idea of missing a potential patient, and they lack the ability to assess the risks and benefi ts of creating new conditions” New panels, free of fl icts of interest on those panels,” definitions or setting treatment thresholds confl icts of interest says Barry Kramer, until recently should be as free as possible of confl icts, both One of the strongest argu- a senior manager at the National fi nancial and reputational. ments for maintaining Institutes of Health, “we simply conflicted individu- avoid them.” Not only are experts Panels with broad representation, als on influential with fi nancial ties prohibited from evidence based panels is that most sitting on the National Institutes The National Institutes of Health model also leading medical experts of Health state-of-the-science and calls for panels to be more broadly representa- do paid work for drug consensus panels, if a researcher tive than just those within a particular subspe- or device companies, has a declared view on a question cialty. It specifi es that as a general rule, along and it is almost impossible to being considered, he or she too will be with practising clinicians and researchers, fi nd respected individuals who do not. But a excluded. “Intellectual confl icts of interest can panels should include biostatisticians, epi- recent policy change at the US Food and Drug be equally potent,” Kramer told the BMJ . demiologists, non-health professionals, and Administration has made that argument look A recent example of this model in action was people representing the wider public interest. extremely shaky. Since , tough new guide- the state-of-the-science conference on The addition of a health economist is also criti- lines have strongly discouraged doctors with the diagnosis and management of ductal car- cally important, to assess the cost eff ectiveness major fi nancial confl icts from taking part in cinoma in situ of the breast, a condition often of changing diagnostic categories. the powerful panels advising on which new treated aggressively. The member panel— Given the growing evidence on the social drugs should be approved. “It’s just laziness, which included representatives from nursing, and environmental determinants of health and because it’s much easier to fi nd a confl icted social work, and population health alongside disease, perhaps the membership of newly expert,” said Sidney Wolfe, a member of one surgeons, radiologists, and oncologists—made renovated panels might be broadened even of the newly constituted panels, and director of the dramatic recommendation to change the further. For example, might it be possible that the health research group at the Washington, very name of the condition. The panel wanted the myriad panels that focus in a fragmented DC based organisation Public Citizen, which to remove the “anxiety producing term carci- way on treating surrogate end points like blood has long pushed for such a clean up. Impor- noma” because of the “non-invasive nature” pressure or lipids be subsumed into a broad tantly, the Institute of Medicine’s landmark of ductal carcinoma in situ coupled with its new panel addressing multiple measures to report in also recommended that com- “favourable prognosis.” The group also high- fi ght cardiovascular disease in a more holis- mittees that write clinical practice guidelines lighted the need to better identify women for tic way, which would include representatives should exclude individuals with confl icts of whom tissue abnormalities would not progress from the worlds of transport, building design, interest.­ Wolfe argues that the same rules to breast cancer, in order to prevent them and food regulation, along with doctors and should apply to the panels that defi ne disease, having to risk the side effects of unneeded others? Fran Baum, public health professor at and create the cut-off s for treatment. treatments including tamoxifen and radiother- Flinders University in Australia and a member “The stakes are very great in terms of public apy—“both of which are proven to cause can- of the World Health Organization’s Commis- health,” Wolfe told the BMJ , because the old cer,” says Kramer, currently a contractor to the sion on the Social Determinants of Health, panels are “constantly broadening the numbers National Cancer Institute, and editor of people defi ned as ill and recruiting millions of the cancer journal JNCI .
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