Published 21 May 2024
BMJ 2024;385:e076797
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Ravi Gupta, assistant professor of medicine
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Reshma Ramachandran, assistant professor of medicine
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Joseph S Ross, professor of medicine and health policy
Ravi Gupta and colleagues argue that we need to reconsider standards for targeted pharmaceutical marketing to doctors through speaker programmes, consulting programmes, and advisory board positions
In 2022, the pharmaceutical manufacturer Biogen paid $900m to settle a US suit brought by a former employee alleging that the company paid kickbacks to persuade doctors to prescribe its drugs for multiple sclerosis.1,2 Biogen admitted no wrongdoing in making the payment, but the whistleblower suit asserted that the company used consulting fees and honorariums for serving on speaker programmes and advisory boards to induce doctors to prescribe Avonex (interferon β-1a), Tysabri (natalizumab), and Tecfidera (dimethyl fumarate), in violation of the Anti-Kickback Statute. The statute prohibits payments to induce the provision of services paid for by federal programmes, including Medicare and Medicaid, which cover healthcare costs for older adults and low income individuals in the US, respectively. The litigation was filed under the US False Claims Act, a federal law that prohibits falsely billing the government.
The $900m settlement in the Biogen suit was among the largest ever and unique in many respects, but it was the latest in a recent string of US suits concerning drug company marketing. These include numerous opioid settlements totalling more than $50bn, a $3bn settlement with GlaxoSmithKline in 2012 for unlawful promotion of several drugs,3 and a $624m settlement with Novartis in 2020 for using speaker and consulting programmes to promote Afinitor (everolimus) and Gilenya (fingolimod).4 None of the companies admitted wrongdoing.
The actions that formed the subject of these lawsuits raise a fundamental question for regulators in the US and around the world about the appropriateness of excess targeted promotion of drugs and medical devices to doctors. The suits also highlight the need for reforming potentially valuable but easily manipulatable interactions between pharmaceutical and medical device companies and expert physicians who serve as consultants and on advisory boards. Such marketing programmes can harm patients both financially and physically, as companies often promote drugs of marginal comparative clinical value.5,6 Beyond financial costs, promotional programmes can lead to morbidity and mortality through overtreatment, forgoing of other viable treatments, and widespread public health harm that can persist for decades,7 as occurred with promotion of opioids. These suits also have implications for contrasting approaches—none entirely effective—adopted in different countries to regulate drug company engagement with physicians.
Traditional targeted drug industry engagement with doctors
Although drug companies claim to engage in marketing efforts to promote awareness of diseases and therapeutics, they also seek to increase use of their products and maximise revenue.8,9,10 Marketing to physicians in the US mainly takes two forms. The first is direct marketing, including drug representatives visiting physicians’ offices (ie, detailing), providing meals and small gifts, and distributing free product samples.
Between 1997 and 2016, pharmaceutical marketing grew substantially in the US, with direct marketing to doctors accounting for most of the spending.11 Drug industry marketing, particularly through payments to physicians, is clearly associated with greater prescribing of marketed products.5,12,13,14,15,16,17 Even small gifts influence behaviour,18 and the effect on physician behaviour can persist.19 Moreover, higher paid amounts to physicians are associated with higher spending.20,21,22 Indeed, recognising the financial returns of targeted marketing, pharmaceutical companies spend more on marketing than on research and development 23 and prioritise the promotion of drugs with marginal comparative clinical value, which are more costly and less likely to be novel, effective, and safe.6
Subtler pharmaceutical industry engagement with doctors
The second form of marketing is often subtle and involves paying or remunerating doctors to provide services to the company. This practice was raised in the Biogen case and other US lawsuits. Physicians have unique expertise that can help companies with research and development, along with marketing and promotion. These services can include contracted research, advisory board service, and other consulting arrangements, as well as serving on speaker programmes as part of marketing campaigns. The doctors are generally leaders in their field, known as key opinion leaders. At speaker meetings, often intended to promote pharmaceutical products, doctors nearly always use company presentations that represent the product favourably.24 One of the main functions of key opinion leaders is to amplify the company’s message by influencing prescribing behaviour of other doctors. Potential bias in these presentations may downplay harms or inflate benefits of drugs, leading to possible physical or financial harm to patients. From 2013 to 2022, 57% of US physicians reported receiving industry payments totalling $12.1bn, most of which related to pharmaceutical detailing and speaking or attendance at speaker presentations.25 Engaging as a consultant or advisory board member is less common but often more lucrative.26
The industry practice of paying doctors as speakers, consultants, and advisory board members may represent appropriate remuneration given their clinical and scientific expertise. However, such forms of engagement can be exploited to influence prescribing of potentially harmful or ineffective medications. The US Office of Inspector General expressed concern about the drug industry’s interactions with doctors as early as 2003.27 In 2020, given the large amount of continued payments to US physicians for speaker related services, the office highlighted the inherent risk of fraud and abuse in the speaker programmes (and considered them in potential violation of the Anti-Kickback Statute and the 2009 Pharmaceutical Research and Manufacturers of America code on interactions with healthcare professionals, box 1).28 The report expressed scepticism about the educational value of speaker programmes.29 The existence of other methods for doctors to learn about pharmaceutical products without company remuneration, it argued, suggested that one aim of the speaker programmes is to induce or reward prescribing of the product. Moreover, paid service of a physician as a consultant or advisory board member can be in tension with their involvement in activities such as designing disease awareness campaigns and management programmes and defining diagnostic criteria and treatment thresholds.30
Box 1
Characteristics of speaker programmes that could violate the US Anti-Kickback Statute 28
- Little or no substantive or new information presented
- Presence of alcohol, particularly when free, or a meal exceeding modest value provided to attendees
- Use of venues such as restaurants or sporting events that are not conducive to information exchange
- Company sponsors a large number of events on similar or the same topic or product, especially when there has been no substantive change in relevant information
- Considerable amount of time with no new medical or scientific information and absence of a new
- Food and Drug Administration approval or indication for the product
- Doctors attend multiple events on similar or the same topics (either as a repeat attendee or as an attendee after being a speaker on similar or the same topic)
- Attendees include people who do not have a legitimate reason for attendance, including friends, significant others, or family members of the speaker or doctor attendee, as well as employees or medical professionals or staff who are members of the speaker’s medical practice
- Speakers or attendees selected based on past or potential revenue that they have or will generate by prescribing or ordering the company’s product
- Doctor speakers are paid more than market value for their speaking service or paid after accounting for volume or value of past business generated or potential future business by the doctors
Biogen rewarding doctors with payments for prescribing its drugs
The Biogen suit, consistent with details disclosed in settlements with Novartis, GlaxoSmithKline, and opioid manufacturers, alleged that at least three features of Biogen’s speaker programme violated the Anti-Kickback Statute. First, it was alleged that instead of inviting doctors based on their scientific or clinical expertise, Biogen routinely used detailed prescribing data to systematically select, engage, and reward doctors who were among the highest prescribers of multiple sclerosis drugs in the US, particularly for Biogen’s products. The second alleged violation involved the content and frequency of speaker events. From 2009 to 2014, Biogen held 12 800 speaker events for multiple sclerosis drugs, more than 1000 of which included only one or no physicians among the attendees. The third impugned feature was the extent and lavishness of the remuneration, including expensive meals and alcohol at upscale venues.
Consultant programmes are generally less common than speaker programmes. However, Biogen paid 50.5% and 67.1% of the US doctors writing an average of 500 and 1000 prescriptions a year, respectively, for Biogen’s multiple sclerosis drugs as part of the speaker or consulting programme during 2009-13.31 Biogen held more than 100 consultant meetings annually, and it held a large roster of consultants from whom it solicited advice only sporadically, suggesting that the programme did not necessarily seek expert advice.
The Biogen suit also uniquely involved expensive specialty drugs with specific market dynamics, whereas previous suits under the False Claims Act concerned less expensive drugs such as gabapentin.32 Drugs for chronic degenerative conditions such as multiple sclerosis have a consistent market, even though relatively few patients are affected, as patients rarely discontinue drug treatment.
Lessons from lawsuits and potential solutions
The lawsuits suggest that standards for targeted pharmaceutical marketing must be reconsidered, and reform is needed for soliciting doctors’ expertise through consulting programmes and advisory boards. Claims about the virtues of targeted pharmaceutical marketing cloak important facts. In light of the opioid settlements and other companies’ apparent targeting of high prescribers to participate in speaker programmes and advisory boards, it is difficult to believe that such programmes seek primarily to educate prescribers. The growth in medical education that is not sponsored by industry, including academic detailing,33,34 other sources of academic continuing medical education content, and digitally based healthcare resources for clinicians could mitigate the influence of, and perceived need for, drug company detailing and speaker programmes.
Reforming consulting programmes and advisory board membership, ostensibly designed to solicit expertise from doctors, is more complex.35 Although some may argue that doctors should not have any involvement with industry, the drug and medical device industry is a firm fixture in both US and European healthcare systems. Prohibiting research collaboration between academics and scientists and the pharmaceutical and medical device industry may be counterproductive if it leads to, for example, less well designed clinical trials or an inadequate understanding or purview of a drug’s safety.
Consulting programmes and advisory boards may offer value in the right setting,36 particularly for research collaborations, but they can be easily exploited, as alleged in the Biogen suit. While doctors cannot be expected to provide free services to companies, clearer disclosure of the specific services provided—which should involve actual work conducted on behalf of the company—and the exact remuneration (including non-monetary), as well as banning quid pro quo arrangements, is essential.
Current strategies to regulate the misuse of speaker and consultant programmes include professional standards and fiscal deterrence. However, as healthcare has become increasingly profit seeking,37 particularly in the US, professional standards have become compromised. The growing financialisation of the healthcare system,38 stemming from increasing influence of financial “markets, motives, institutions, and elites” in our society and the associated “moral injury” stemming from prioritising profit may further erode professional standards.
Moreover, in the US, financial penalties have been insufficient to deter companies from misusing speaker programmes, particularly for expensive drugs. When Purdue cut promotional spending on OxyContin because of threats of penalties, its competitors actually increased promotion of their opioids.39 Moreover, Biogen was not deterred by the earlier opioid settlements and the GlaxoSmithKline suit. As the 2020 inspector general’s report stated, inherent risks associated with speaker programmes are outweighed by their potential rewards, tempting companies to cross acceptable limits. Given the profits from increased prescriptions, the penalties may simply be the “cost of doing business.”40 Because many settlements are recent and reflect company actions from nearly a decade ago, whether companies will respond to the renewed enforcement and monetary penalties by ceasing such practices remains to be seen. Nevertheless, although the growing scrutiny of such marketing practices is welcome, relying on professionalism and deterrence is likely to be inadequate.
Whereas the US has adopted an adversarial system in which whistleblowers can spur litigation by drawing attention to companies’ purportedly illegal activities, other countries, including Australia, Sweden, and the UK, have relied on industry self-regulation. In the UK, for example, the Association of the British Pharmaceutical Industry code of practice is administered by the Prescription Medicines Code of Practice Authority, an industry body. Self-regulation relies less on punitive strategies and more on education, persuasion, and negotiation.41 However, as the case of Astellas’s off-label promotion of the prostate cancer drug enzalutamide showed, self-regulation may be insufficient, as it can overlook violations and limit in-depth investigations such as those in the Biogen lawsuit.42,43
Neither the adversarial nor the self-regulatory approach appears optimal, underscoring the challenge of reform. Other strategies to deter bad behaviour may include forcing companies to admit wrongdoing as part of lawsuits to maximise reputational harm, prohibiting company use of physician prescribing data to target marketing efforts, and excluding repeat offenders from government funded medicine reimbursement schemes.
The medical communities in the US and globally must also consider their complicity and wilful ignorance of the true intent of speaker and consultant programmes. No doctors were held liable in the Biogen suit, but there may be a need to reconsider whether doctors should be prosecuted when they participate in explicit kickback schemes, especially those that harm patients and public health. The lawsuits from the past decade, including the Biogen suit, remind us of the imperative to reform excess marketing programmes targeting doctors and to ensure that clinicians are consistently making prescribing decisions that are in the best interests of patients.
