Saturday, 12 August 2017

Gynaecologists and industry: ain't no sunshine

Cynthia M. Farquhar Paolo Vercellini Jane Marjoribanks Human Reproduction, Volume 32, Issue 8, 1 August 2017, Pages 1543–1548, Published: 03 July 2017 Article history PDF Cite Permissions Share Abstract The field of reproductive medicine is known for its innovations, and where there is innovation there is marketing and engagement with the doctors who are potential prescribers and users of those innovations. Financial connections between drug and device manufacturers with doctors have been extensively debated over the past decade. On one hand, relationships between doctors and industry could be considered synergistic by allowing the development of improved treatments. On the other hand, payment (and other benefits) from industry to doctors may subtly shift the main objective of the collaboration from patients’ health to mutual benefits for both doctors and industry. Fertility patients can be considered ‘vulnerable’ as they face the multiple challenges of seeking to be parents, understanding complex and expensive fertility treatments that are by no means universally successful, and at the same time are under pressure because of their ever-increasing age. They are entitled to receive the most cost-effective treatments. We suggest that specialists in the field of reproductive medicine should be transparent about the receipt of financial benefits, including funding from industry, as it may be influencing both research outcomes and treatments that patients are offered. We also recommend that payments arising from industry-sponsored research should be centralized in institutional funds and not paid directly to researchers. And there should be transparency about the source and the purpose of the payment. Industry sponsorship of medical societies and their educational events should be kept to a minimum and declared quantitatively in societies’ websites and scientific programme brochures. Industry sponsorship of scientific meetings should not include the right to host educational symposia or speakers within the programme. All speakers should declare their conflicts of interest (COIs) at their meetings. Guideline groups should require all members to declare their financial COIs before meeting and exclude or limit those members with COI. Governmental authorities should not allow continuing medical education credits to those educational events not complying with the above policies. The crucial role of medical journals as ‘gatekeepers’ for identifying ‘science’ must be reaffirmed. ethics, assisted reproduction, infertility, conflict of interest, professional society, relationships, industry, funding, sponsorship, gynaecology Topic: conflict of interest cost effectiveness disclosure education, medical, continuing fertility gynecology internet pamphlets parent reproductive medicine societies, medical sunlight knowledge acquisition infertility therapy devices, medical marketing host (organism) transparency Issue Section: Debate Introduction The issue of relationships between doctors and industry is a hot topic. In 2015 The New England Journal of Medicine published three articles (Rosenbaum, 2015a,b,c) suggesting that physicians with industry relationships have been unjustifiably demonized. An accompanying editorial (Drazen, 2015) questioned why medical journal editors remain concerned about authors with pharma and biotech associations. A response from three former senior editors of The New England Journal of Medicine soon appeared on the pages of the BMJ (Steinbrook et al., 2015) entitled ‘Justifying conflicts of interest in medical journals: a very bad idea’ and noting that it is impossible for editors and readers to know one way or the other whether doctors with ties to industry have a conscious or unconscious pro-industry bias. And to follow up in 2017, the Journal of the American Medical Association dedicated a whole issue to a series of articles dealing solely with the seemingly all-too-prevalent problem of conflicts of interest (Bauchner and Fontanarosa, 2017). They are not angels… The pharmaceutical industry has been widely accused of furthering its own ends by various means such as expedient trial design and presentation of data, suppression of unfavourable findings, regulatory capture, ghostwriting, funding of continuing medical education (CME) and marketing of off-label drug use. Doctors may unwittingly become involved in a number of ways; drug marketing by recruiting for ‘seeding’ trials that are aimed primarily at getting prescribers familiar with the new drug rather than generating evidence (Goldacre, 2012), taking direct payments for membership of advisory boards, speaking at industry-sponsored symposia, and receiving generously sponsored conference travel and accommodation with or without a speaking commitment. High status respected physicians are engaged as ‘key opinion leaders’ to influence their peers, and nonfinancial inducements include deference and the kudos of being treated as an expert (Sah and Fugh-Berman, 2013). Industry could almost be considered to ‘own’ medical education, as they sponsor many scientific meetings and almost all medical conferences. Medical publishing is also vulnerable, as there is little public scrutiny of the editorial process leading to publication of studies supported by industry. There is strong evidence that industry tactics work. A recent Cochrane systematic review (Lundh et al., 2017) includes 75 studies that compared primary research studies of human drug or medical device studies sponsored by the industry versus studies with other sources of sponsorship, and concludes that industry-sponsored studies are more likely to find in favour of the sponsor's products. Doctors often believe that their own behaviour is immune to industry marketing, even though they concede that their peers may be susceptible (Sah and Fugh-Berman, 2013). Yet there is ample evidence that gifts and payments from industry influence clinical practice and especially drug prescribing (Spurling et al., 2010; Robertson et al., 2012; Lieb and Scheurich, 2014; Lublóy, 2014; De Jong et al., 2016; Ornstein et al., 2016; Perlis and Perlis, 2016; Yeh et al., 2016). Industry influence applies also at trainee level: a large survey found that medical students and residents with more exposure to pharmaceutical marketing were less informed about evidence-based prescribing and were more likely to recommend brand-name drugs over more cost-effective options than those less exposed (Austad et al., 2014). Let the sun shine in Since 2007 the Physician Payments Sunshine Act (PPSA) has required US pharmaceutical and medical device manufacturers to collect, track and report financial relationships with physicians and teaching hospitals, and it is now part of the 2010 Patient Protection and Affordable Care Act. In September 2014 the information was made public for the first time (Merino, 2013). The extent of the payments was staggering, with 4.4 million individual transactions totalling $US3.5 billion. More than half a million doctors and 1360 teaching hospitals received at least one payment, not including funding for CME (Agrawal and Brown, 2016; CMS, 2014). There have been calls for other jurisdictions to follow the example of the Sunshine Act (Farquhar et al., 2015; Fabbri et al., 2016). In 2014, the European Federation of Pharmaceutical Industries and Associations (EFPIA, 2017) brought in new transparency provisions that apply to all national member groups, requiring disclosure of payments to individual doctors, either on a company website or on a central platform (EFPIA, 2017). It appears that the requirement for disclosure has had an effect on industry behaviour, as since 2011 there has been a dramatic drop in payments to doctors for promotional lectures, according to the US not-for-profit news organization ProPublica (Ornstein et al., 2014). Similarly, GlaxoSmithKline have agreed that from June 2016, they will publicly disclose information on payments made to healthcare professionals in Europe, as part of an initiative by the EFPIA (GSK, 2017). These developments are encouraging, although the impact is likely to be weakened by dependence on self-regulation: some countries only require member companies to comply, some do not include gifts such as hospitality and some (such as the UK) have an ‘opt out’ clause. Countries also differ in how accessible and searchable these databases of payments are. Auditing of the way different companies comply with these regulations would be a useful area for further research. How widespread are payments to doctors from industry? Since June 2016 limited data have been made available by the Association of the British Pharmaceutical Industry (ABPI) for 109 companies in the United Kingdom. A total of £340 m was paid to healthcare professionals or organizations such as universities and hospitals or medical societies in 2015. While two-thirds of the payments were for research, £111 m was for other activities such as consultancy, education, and attending and arranging conferences (ABPI, 2017). Companies spent ~£1550 per healthcare professional and ~£9500 per healthcare organization (ABPI, 2016). However, healthcare professionals were able to ‘opt out’ and recent data show that only ~55% of individuals have consented to be named in the database (ABPI, 2017). A healthcare transparency register was introduced in the Netherlands in 2014. Payments from organizations to doctors are required to be disclosed and are available on a searchable website which includes most doctors in the Netherlands. However, the register does not cover symposia participation, and disclosure only applies to payments made to individuals from companies that are operating and active in the Netherlands, and not payments to foundations or payments made from outside of the country (HTC, 2017). Australia has introduced a self-regulatory system of disclosure. As of October 2016 reporting is mandatory, but accessibility is suboptimal because the data appear on individual company websites (Medicines Australia, 2017). Other measures to improve transparency include the AllTrials campaign, which calls for all past and present clinical trials and their results to be registered on a central database (Henry and Fitzpatrick, 2015) and OpenTrialsFDA, which aims to make accessible the information currently buried in the drug approval packages of the US Food and Drug Administration (Goldacre and Gray, 2016). Another interesting development comes from our students; the American Medical Student Association has initiated a ‘PharmFree Scorecard’, that grades US medical schools with regard to their policy on interactions between their students and faculty and the pharmaceutical industry (Austad et al., 2014; Ross, 2014). Ain't no sunshine: what about gynaecology and reproductive medicine? Self-serving science There are well-known examples of industry efforts to influence prescribing decisions in the field of gynaecology. In litigation against Wyeth in 2009, the company was forced to release evidence of a ghostwriting campaign designed to promote the use of menopausal hormone therapy (HT). From 1996 to 2004, academic physicians were invited to ‘author’ articles prewritten by a ghostwriting company hired by Wyeth. Dozens of ghostwritten reviews and commentaries were published in medical journals and supplements. The articles downplayed the risks of breast cancer associated with HT, promoted the supposed cardiovascular benefits of HT, encouraged off-label use for indications such as wrinkles and prevention of dementia, and cast aspersions on competing therapies (Fugh-Berman, 2010). In an example of apparent ‘disease creation’, a study published in JAMA in 1999 (Laumann et al. 1999) claimed a 43% prevalence of ‘female sexual dysfunction’. The paper did not initially acknowledge that two of the authors were closely linked to Pfizer, who were developing drugs to address this newly-discovered epidemic. The prevalence and definition of female sexual dysfunction remains highly controversial. Industry sources promote drug-based solutions and easy-to-use diagnostic toolkits, while non-industry sources focus on non-drug solutions, suggest much lower estimates of prevalence, and urge a focus on clinically significant symptoms (Moynihan, 2010; Mitchell et al., 2016). A systematic review comparing industry and non-industry funded clinical trials of treatments for endometriosis found that industry-funded studies were more likely to compare their product against a placebo rather than an active comparator and more likely to report short-term outcomes (Guo and Evers, 2014). There is also evidence that industry trials on endometriosis are less likely to publish their findings (Guo and Evers, 2013). Industry sponsorship With regard to industry sponsorship of doctors in the field of gynaecology and reproductive medicine, specific data are limited. We review below the available evidence, but acknowledge that our commentary is limited by the lack of evidence specific to reproductive medicine and the very limited reporting in most countries. These challenges highlight the need for greater disclosure of industry ties. In the UK, the 2015 ABPI data included 300 individuals in the specialty of obstetrics and gynaecology who disclosed receiving payments (ABPI, 2016). This represents nearly 7% of obstetricians and gynaecologists on the General Medical Register but does not include those who may have received payments but did not disclose. The subspecialty of reproductive medicine was not reported separately and the number of payments remains unknown, although one of the highest paid individuals on the database was a reproductive medicine specialist who received nearly £20 000 for consultancy and fees and travel. The largest payment went to a private fertility clinic which received £21 090. A patient organization for infertility also received over £30 000 for sponsorship. In the Netherlands, in 2015 out of 100 subspecialists in fertility medicine and surgery, 18 received payments from pharmaceutical companies which included Bayer, Merck, Gedeon Richter, Astellas and Pfizer. The highest single payment was €5850 (HTC, 2017). In Australia, according to Medicines Australia (2017) the industry spent $11 447 745 from October 2011 to September 2015 on sponsored events with a focus on women's health or reproductive health. As reproductive medicine is not a searchable category and there are hundreds of pages of documents, we selected one of the leading companies in fertility treatments and calculated that in the 6 months from April to September 2015, Merck Serono hosted 43 events totalling over Aus$312 475 to gynaecologists and fertility doctors. This included Aus$74 038 for travel and accommodation for 31 individuals to the annual scientific meeting of the European Society of Human Reproduction and Embryology (ESHRE). Other companies have similar levels of expenditure; MSD (Australia) over the same time period spent $279 969 on fertility clinic staff and gynaecologists including numerous journal clubs and direct sponsorship of three scientific meetings. Payments in the USA in the field of obstetrics and gynaecology are considerably higher than those reported in Europe and Australia. This can be attributed partly to the requirement for complete disclosure (there is no opting out) and also partly to the inclusion of devices in the US data. Analyses of the Open Payments data have shown the following: Almost 30 000 obstetrician–gynaecologists received non-research related industry money in 2014 (Tierney et al., 2016). Obstetrics and Gynaecology ranked fourth out of 35 medical specialty groups in terms of number of doctors paid by industry, and received more than $60 million, which constituted 3.3% of the total amount of money transferred to all considered doctors. US gynaecologists received more than 300 000 payments (3.1% of all payments in 2014), and were the seventh most frequently paid specialists (Tierney et al., 2016). The subspecialty of reproductive endocrinology and infertility received more than $3 million through over 14 000 payments to more than 1000 doctors in 2014. The highest paying manufacturer in this field was Cooper Surgical, Inc., a leading company in preimplantation genetic screening, with a total value transferred of around $1.4 million (Tierney et al., 2016). In 2015, 1025 reproductive specialists received a payment (Centers for Medicare & Medicaid Services, 2017). Merck Sharp & Dome Corporation, the manufacturer of recombinant pituitary gonadotrophin corifollitropin alfa and follitropin beta, as well as of the GnRH antagonist ganirelix, was the third highest paying company in the overall obstetrical and gynaecological area, with more than $2 million transferred to 17 980 doctors in 2014 (Tierney et al., 2016). The top 1% of the highest paid obstetricians and gynaecologists (n = 297) received 74% of the total value transferred to our specialty, with a median annual payment of more than $33 000 in 2014 (Tierney et al., 2016). Total and median payments to gynaecology oncologists were high relative to other specialities. In 2014, 77% of US gynaecologic oncologists received industry payments and just over 1 in four received a payment from Intuitive Surgical Inc., the company that manufactures the daVinci robot (Shalowitz et al., 2016; Tierney et al., 2015). 765 gynaecologic oncologists accepted research-unrelated payments totalling $1 957 004 in 2014 (mean value $2500 each), 48 receiving > $10 000 (Shalowitz et al., 2016). These detailed analyses of the data contrast with other reports that minimize the problem. In one example (in this case to paediatricians), the company-reported data on payments gave a ‘median individual payment’ of $14 ‘commonly for meals’ and ‘median total pay per general paediatrician’ of $89.4. In reality this approach fails to highlight the fact that cheap meals are often linked with attendance at speeches delivered by highly paid key opinion leaders (Braillon et al., 2012) Disclosure of conflicts of interest A review of abstracts and disclosures of 335 doctors presenting at the annual meeting of the Society of Gynaecologic Surgeons in 2015 found that 62% had transactions reported to the Center for Medicaid and Medicare Services, which totalled $1.99 million (Thompson et al., 2016). Yet only seven doctors listed the companies with their abstracts. The total amount of all non-disclosed transactions was $1.3 million. Payments to a single physician ranged from $11.72 to $405 903.36. This report suggests that gynaecologists are very poor at voluntary disclosure of financial relationships with industry and that the disclosures that are generally required of presenters by medical societies are not reliable. Since September 2014 doctors in the United States have been required to disclose their associations with industry when presenting at meetings or submitting manuscripts for publication (Merino, 2013). Both ESHRE and ASRM require these disclosures but this is often not enforced even when the speaker is known to be a consultant for various companies. Some speakers announce that they have balanced conflicts as if this in some ways mitigates against any influence the payments may have had on the content of their presentation. Many speakers make light of being required to make disclosures and in doing so undermine the intent of providing the information. There is very little transparency outside the United States and we simply do not know how much industry influence there is within the boards of scientific societies, editorial teams of specialty medical journals, guideline writing panels, and speakers at educational events. We believe that broad discussion of conflicts of interest (COIs) in gynaecology could help colleagues to question the value of the information they are receiving through medical journals and educational events, as well as critically assess their own clinical activity in order to identify and resolve potential or actual COIs that could be detrimental for patients. Is there a better way? There must be a way out of here! We consider that we need a profound change in our specialty. It should start with our universities and hospitals, our medical societies, and – above all – our scientific journals. Collaboration between the research and development divisions of industries, universities and hospitals is essential and productive. However, this should not involve industry payments to individual academics. Arnold Relman, former editor of the New England Journal of Medicine, in his last published words warned: ‘now, more than ever, it is important that leaders in academic medical centres set an example for students and faculty by concentrating on advancing the non-for-profit social purposes of these institutions. They cannot do this if they also have ties to pharmaceutical businesses’ (Relman, 2014). As an alternative, money from industry-sponsored research could be centralized in institutional funds. Industry could approach independent publicly-funded networks such as the Reproductive Medicine Network of the National Institute of Child Health and Human Development (NIHCD), the National Institute for Health Research (NIHR) in the UK and the Dutch consortium of clinical trials, all of which have a record of conducting successful clinical trials. Another option would be for national or regional organizations to evaluate industry proposals and provide oversight of the research without being paid directly by industry. We need to move towards routine quantitative COI declaration at meetings, on medical society websites and in scientific programme brochures (Fabbri et al., 2016; Vercellini et al., 2016). Individuals with COIs either should not be included in guideline groups, or should have only a strictly limited role. Meeting organizers should avoid including speakers with COIs and governmental authorities should not allow CME credits to educational events not complying with the above policies. Moreover, we should all avoid sponsored symposia and social occasions. CME should focus on education, as doctors are among the most highly paid professionals and can therefore be expected to pay for their own medical education. We look forward to commercial-sponsor-free annual conferences that disseminate and advance independent research and provide unbiased evidence about developments in clinical practice. This may well reduce the number of meetings, but would improve their educational value. Sah and Fugh-Berman (2013) suggest that if a critical mass of respected physicians avoids being placed in positions of indebtedness to industry and if greater academic prestige accrues to an arms-length rather than to a close relationship with industry, then a new social norm may emerge that rejects transactions fraught with conflicts of interest. That norm would promote rather than undermine patient care and scientific integrity. Finally, scientific journals have a crucial role as ‘gatekeepers’, safeguarding the relationship between industry and academia. For a biased study to achieve publication in a prestigious journal is the conditio sine qua non for any further step in the cascade that can lead to worldwide dissemination of fallacious scientific information and distortion of prescribing practices. Currently it is unusual for a journal to ask the peer reviewer to disclose potential COIs prior to seeking the review, let alone publish them. Moreover, it is currently difficult, if not impossible, to know whether members of editorial boards have financial COIs themselves. In these circumstances, it is not possible to prevent the publication of sponsored trials that may influence the prescribing behaviour of doctors and have harmful consequences for patients. Given the critical role of journal editors, the scientific community and the public are entitled to know the names and CoI disclosures of editors and peer reviewers involved in the scrutiny and publication of manuscripts potentially influencing medical practice. In other word, the peer-review process should be rendered transparent, and editorial offices should be transformed into glasshouses. In 2009, a BMJ cover showed two dancers, the female one personifying industry, the male one academia and doctors. The title was ‘It takes two to tango’. Editor Fiona Godlee cited Iain Chalmers as saying, I do not blame industry for trying to get away with anything that is normally considered to be its primary purpose, which is to make profits and look after its shareholders’ interests. It is our profession that has colluded in all of this and been prepared to go along with it—we are the people to blame because we need not have stood for it (Godlee, 2009). Authors’ roles P.V. and C.F. jointly planned the outline of the manuscript. C.F. prepared the manuscript and P.V. and J.M. contributed intellectual input and critically revised it. All authors approved the final draft. Funding None. 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