Conflict of interest: forward not backwardBMJ 2015; 350 doi: https://doi.org/10.1136/bmj.h3176 (Published 11 June 2015) Cite this as: BMJ 2015;350:h3176
All rapid responses
Re: Conflict of interest: forward not backward
Lenzer and Brownlee1 make a strong argument for financial conflicts of interest trumping personal ones and give (and have given) disturbing examples of lack of transparency in the makeup of advisory panels and guideline committees; it may well be that for these circumstances financial conflict predominates.
Most of such bias follows what I might call conflicts of commission – advice, guidelines, opinions. But there is also an important area, of conflict of omission. For example, by not supporting comparative trials, the soon-to-be-out-of-patent vs the new, drug manufacturers deny prescribers an informed (and for pharma a potentially financially embarassing) choice.
In the early 1980s, my largest single drugs budget expenditure was acyclovir (Burroughs-Wellcome 1981), some £80 for a five day course to treat genital herpes; and even more for the vital and successful suppressive therapy. As the impending patent expiry neared we were exhorted to change to valaciclovir (GSK 1995), equally expensive but “better“. Generic acyclovir arrived, retailing at some £5 for five days. What I (we) needed was a comparison between the new and the old but, without external funding, such a trial was impossible. For simple financial survival (and with no measured or measurable ill-effects) we continued to use generic versions of the old drug.
Likewise, having used Beecham’s ampicillin (1963), with probenecid, for the treatment of gonorrhoea for many years (and getting away with a dose of 1G compared with the CDC‘ recommended 3G), we turned, at the expiry of its patent, to the use of generic ampicillin, rather than Beecham’s new expensive amoxycillinin (1972), with excellent results but with only historical data for comparison.
Lenzer and Brownlee1 suggest that: “ … more important is the biasing effect of financial conflict of interest on clinical research and the effect it has on the way clinicians and patients alike think about disease and treatment” . However. during my years as a physician, I was regularly reminded of COI without financial motivation or commercial pressure that had just such the effects that they emphasize; I therefore have sympathy with Dr Godlee’s view that “non-financial conflicts such as academic passion and personal personal belief...“ have an equal importance.
What about political conflict of interest? In the late 1980s clinicians and patients were both shepherded towards belief in a burgeoning heterosexual HIV/AIDS ‘epidemic‘. Communicable Disease Reports giving tables for AIDS and HIV numbers, covering the end of 1986, provide ample evidence. The AIDS table for September2, as in previous months, includes a footnote that, of 12 cases acquired abroad, “10 were associated with sub-Saharan Africa“. By October3 the footnote had gone, and the December AIDS table4 categories simply offered “presumed infected abroad“. The December HIV table4 was reduced to the one category ‘heterosexual‘. No mention of abroad or Africa.
Whoever was responsible for this re-labelling (the CDSC, its parent the PHLS, the Department of Health, or the Government), the stage was set in January 1987 for the launch of the ‘Don’t die of Ignorance‘ campaign, with John Hurt’s voice intoning over the fallen AIDS monolith. Newspaper editors and journalists did not have to look far for official evidence of an increasing HIV/AIDS epidemic.
This change in wording of the heterosexual categories in the 1980s allowed speculation not only that there was increasing transmission within the UK but that an unknown number, even a majority, of the 'known exposure abroad' category were UK nationals who had travelled and become infected before returning home. This was the interpretation put on the figures by the CDSC themselves when they suggested advice to travellers on risks of HIV when abroad5. The CDR did not publish correspondence, critical or otherwise. A fuller version of this saga is available6.
This misinterpretation, accepted from the late 1980s to the mid-1990s, did have a significant “… effect on the way clinicians and patients alike think about disease1”. Clinics were overwhelmed by worried well patients while there was no extra provision of help, or targeting, for an identifiable section of the population who needed care.
Finally, whether the ‘direction‘ of the COI is largely uni- or multi-directional, pro or anti, may well differ between personal and financial conflicts but should not side-track us into a beauty contest between the two. Guidelines and reviews are clearly more open to suspicion of financial conflict but experts and authorities with hobby-horses, idées fixes or Departmental reputations susceptible to bruising, may have equally deleterious effects on patients and doctors.
1. Lenzer J and Brownlee S 2015 http://www.bmj.com/content/350/bmj.h3176/rapid-responses
2. CDSC. Acquired Immune Deficiency Syndrome: United Kingdom: October 1986. CDR 86/44, p4
3. CDSC. Acquired Immune Deficiency Syndrome: United Kingdom: November 1986. CDR 86/48, p4
4. CDSC. Acquired Immune Deficiency Syndrome: United Kingdom: January 1987. CDR 86/53, p3-4
5. Noone A, Gill ON, Clarke SE, Porter K. Travel, heterosexual intercourse and HIV-1 infection. CDR 1991; 1:R39-43
6. Barlow D. (2004) HIV/AIDS in ethnic minorities in the United Kingdom, In Ethnicity and HIV: prevention and care in Europe and the USA, IMP London; Eds, Erwin, Smith and Peters. 21-46
David Barlow July 1 2015
Competing interests: No competing interests
The professions are essential and beneficial, but enigmatic and problematic. Despite their exalted status, titles, expertise, and altruism, the professions are also an elite salesforce for wealthy, powerful, secretive industries. Physicians represent the drug, device, and hospital industries; attorneys represent the financial, litigation, and justice industries; military represent the weapons industry; media represent the advertising industry; and politicians represent the lobbying industry. Let's recognize that the professions have undisclosed conflicts of interest, and judge them accordingly. But let's not expect the professions to make any confessions.
Competing interests: No competing interests
Fiona Godlee’s thoughtful editorial includes one comment that needs examination. She states, “…there is little dispute that non-financial conflicts of interest—such as academic passion and personal belief—are just as important, if harder to track” as financial conflicts.
We believe personal or intellectual conflicts are not as important as financial conflicts, even though they may be just as powerful as financial conflicts when it comes to individual physicians treating their patients. Far more important is the biasing effect of financial conflict of interest on clinical research and the effect it has on the way clinicians and patients alike think about disease and treatment.
As our colleagues and we have written, the biasing effect of financial conflicts differs from other forms of bias in two fundamental ways. Personal biases are generally, though not always, multidirectional; while some experts might prefer one approach to patient care for personal or philosophical reasons, or may believe fervently in a treatment that is being tested, others are likely to take a contrary stand. The bias introduced by financial conflicts, by contrast, is almost invariably unidirectional for two key reasons: Firstly, the majority of clinical research is sponsored by industry, whose primary interest (and fiduciary duty to shareholders) is selling its products. As a result, trial design, analysis and publication is generally biased in favor of the sponsor’s product.
Secondly, industry funds vast networks of lobbyists, patient groups, researchers, lawyers, medical writers, advertising and social networking specialists, marketers, and others, all of whom amplify those positive results and counter their critics. These networks, backed by resources available to industry but rarely (if ever) to individual academics or community doctors, make financial conflicts of interest a powerful form of bias associated with vital breaches of public trust. Failure to take measures to reduce or eliminate this form of bias on grounds that other biases exist allows the pursuit of perfection to become the enemy of the good.
It is important to counter the widespread belief that personal conflicts are just as important as financial conflicts when it comes to research and guideline panels, in part, because claims of “intellectual conflict” have been used to exclude highly skilled and respected experts without financial conflicts, such as Curt Furberg,1 Sidney Wolfe2 and Jerome Hoffman from serving on guideline3 and Food and Drug Administration panels - while keeping individuals with financial conflicts on those same panels.
1. Lenzer J. FDA bars own expert from evaluating risks of painkillers. The BMJ. 2004;329(7476):1203. http://bmj.bmjjournals.com/cgi/content/full/329/7476/1203?ehom.
2. Lenzer JE, Keith. The Yaz Men: Members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties. Washington Monthly. Jan 9, 2012 ed2012. http://www.washingtonmonthly.com/ten-miles-square/2012/01/the_yaz_men_me....
3. Lenzer J. Why we can’t trust clinical guidelines. BMJ. 2013-06-19 10:17:59 2013;346:f3830. http://www.bmj.com/content/346/bmj.f3830.
Competing interests: JL: Writes for The BMJ SB: No conflicts