Intended for healthcare professionals

Feature Essay

Industry-funded medical education is always promotion—an essay by Adriane Fugh-Berman

BMJ 2021; 373 doi: https://doi.org/10.1136/bmj.n1273 (Published 04 June 2021) Cite this as: BMJ 2021;373:n1273
  1. Adriane Fugh-Berman, professor
  1. Georgetown University Medical Center, USA
  1. ajf29{at}georgetown.edu

Although awareness of individual conflicts of interest and ethical problems with physician-industry relationships has increased, few people realise just how much continuing education is used for product promotion, writes Adriane Fugh-Berman

Many countries require doctors to complete a certain number of hours of continuing medical education (CME, known as continuing professional development in the UK) to maintain a medical license.1 But CME is heavily funded and influenced by drug and medical device manufacturers. And because CME is considered education rather than advertising, no country regulates it as product promotion.

Studies analysing content have shown consistent messaging in industry-funded CME that favours sponsoring companies’ drugs and disadvantages competing products.23456789 The messages work: commercial CME affects prescribing choices. A sudden tripling in prescribing of an antipsychotic—an increase lasting at least three months—at the Minneapolis Veteran’s Affairs Medical Center was traced to a grand rounds presentation by a speaker paid by the manufacturer.10 A 1992 study found that after an all-expenses-paid CME symposium held at a tropical resort, prescription rates for the CME sponsor’s drugs more than doubled.11

Although every study designed to detect commercial bias in CME has been positive, doctors cannot detect bias. Studies that have asked doctors whether commercial bias existed in specific commercially funded CME activities have found that most detect none.12131415 Other studies have found that most doctors do not believe that commercially sponsored CME is biased in general.161718 Only one study, which surveyed Chinese doctors attending a nephrology conference partially funded by industry, found that most respondents thought that industry supported courses were biased.19

That most doctors cannot detect covert commercial bias is unsurprising given the depth to which industry messaging has become ingrained in medicine’s definition of diseases, as well as perceptions of treatments.

Creating a market

Creating diseases, or expanding the market for existing diseases, is key to marketing. Industry-funded CME is designed to increase awareness of what industry calls “disease states;” to encourage off-label use; to emphasise benefits and minimise perceived risks of targeted drugs; and to exaggerate harms of competing treatments.2 “Condition branding” is when a company creates, adopts, or redefines a disease state and then links that specific condition to a targeted treatment.2

CME was used to cast normal ageing as a disease in both men3 and women4 to sell hormonal formulations, for example. Gastroesophageal reflux disorder (formerly heartburn) was created to increase sales for omeprazole and esomeprazole.2

Examples of converting symptoms or risk factors into diseases tailormade for new drugs include premenstrual dysphoric disorder, created to extend patent protection for fluoxetine, and social anxiety disorder, created to establish a marketing niche for paroxetine, an antidepressant that entered the market too late to carve out much market share for depression.2

Industry-funded CME encourages clinicians to diagnose and treat mild symptoms or conditions for which the harms of treatments overwhelm putative benefits. Hypoactive sexual desire disorder was created by manufacturers of the testosterone patch.2 The diagnosis was revived by the manufacturer of flibanserin, another purported libido boosting drug. There is no scientific norm for sexual desire, and lack of interest in sex is profoundly influenced by life stresses, relationship problems, illness, and drugs. Nonetheless, commercial CME activities have increased the percentage of primary care clinicians who indicated that they would screen for this “disease.”2

Promoting “emerging” (off-label, unproven, or disproven) uses of drugs is another way that CME is used for marketing. This gets around laws that prohibit off-label promotion, because CME is not regulated as advertising.6 CME has been used to promote many drugs5 including Neurontin (gabapentin), an antiepileptic that was promoted for migraine, chronic pain, psychiatric disorders, and other off-label uses.7 CME activities on binge eating disorder subtly promoted lisdexamfetamine as a weight loss agent, an off-label claim.8 Most off-label uses of drugs and devices are unproven. It is impossible to assess a risk-benefit ratio without knowing whether benefits exist and when risks are misrepresented.

As a business plan unveiled in a legal case regarding off-label promotion states, “Medical education drives this market.” Another internal drug company document describes a CME programme as a way to support “growth opportunity” in off-label prescribing.7 More than half (54%) of 41 whistleblower complaints regarding off-label marketing of drugs involved CME events with speakers whom companies knew promoted off-label uses.5

Hiding harms

But perhaps the most damaging effect is the omission or minimisation of product harms. Opioid manufacturers have called doctors who are reluctant to prescribe opioids “opiophobic,” and used CME to promote off-label use of transmucosal fentanyl products for migraines, sickle cell pain crises, injuries, and wound dressing changes.9 One study asked participants randomly assigned to read either a CME monograph sponsored by a fentanyl manufacturer or a clinical practice guideline on chronic non-cancer pain and to summarise the main messages.9 Those who read the industry-funded article focused on the benefits of opioids and largely failed to mention addiction or other serious adverse effects. Those assigned to the non-industry-funded article noted, correctly, that evidence was lacking for the use of opioids in chronic non-cancer pain, and that opioids were linked to addiction and death.9 Another study found that not one of 27 industry-funded CME modules on binge eating disorder mentioned that the amphetamines recommended for treatment can cause addiction, myocardial infarction, stroke, and death.8

Elsewhere, materials disclosed in litigation have shown that a CME journal supplement commissioned for a manufacturer of oestrogen drugs was specifically designed to “diminish the negative perceptions” regarding breast cancer caused by menopausal hormone therapy.4 Marketing messages that exaggerate benefits and minimise harms of targeted therapies in CME activities have been found for hypoactive sexual desire disorder,2 binge eating disorder,8 chronic non-cancer pain,9 and testosterone therapy.3

Influencers

Even if a CME activity is not directly funded by industry, faculty who are funded by industry convey marketing messages. A misapprehension among physicians is that doctors paid by industry are not salespeople because they do not push a specific product. But industry-funded CME activities are designed to persuade learners of industry friendly perspectives without setting off suspicion that the activities are marketing exercises.

Key opinion leaders are industry paid influencers vital to industry-biased “education.” Key opinion leaders are usually academic physicians; medicine is apprenticeship based, and physicians trust their teachers. Companies identify—and also create—key opinion leaders, providing early career academic physicians with speaking engagements and other paid opportunities.20 One study of 75 US industry-funded courses involving testosterone found that more than half of the speakers were directly paid by drug companies for speaking, consulting, or advising; 65 courses used at least one faculty member who had worked for a company that manufactured or marketed testosterone products.3

Selling a drug or medical device is never a key opinion leader’s job. It is their job to sell the disease, preparing the terrain for marketing messages about targeted drugs to be planted. And it’s not just doctors. In the US in 2018, continuing education interactions with nurses, pharmacists, and other healthcare providers increased by 61% over the previous year (some of the increase might have been due to increased reporting).21

“Free” education

Doctors cannot claim CME credit unless events are accredited by organisations that are supposed to ensure objectivity. In the US, the Accreditation Council for CME (ACCME) certifies providers, including universities and medical education and communications companies. The European Accreditation Council for CME (EACCME) does similar for events directly. Both have policies that prohibit mentioning brand names or emphasising specific drugs in CME. Although these policies supposedly reduce industry influence, they align exactly with what industry wants—seemingly objective “education” riddled with marketing messages.

Both accreditation bodies depend on payments from entities that provide industry-sponsored education—a disincentive to effective actions against commercial bias. And although the ACCME claims that 90% of CME activities were not industry supported, it actually stopped counting “equipment, supplies, and facilities” and other “non-monetary resources provided by a commercial interest in support of a CME activity” as commercial support a decade ago. In other words, industry can pay for meeting space, hotel rooms, audiovisual costs, food, and other costs related to a CME event, but as long as the money is paid directly to a hotel, caterer, or other entity, none of the money is reported as “support.”24 The ACCME also doesn’t count advertising and exhibit income as commercial support,24 although industry is unlikely to purchase exhibition space at an event inconsistent with its marketing goals.

Medical education and communications companies are commonly used to hide industry funding of programmes. These companies provide meeting and event coordination, and sometimes writing services, to drug companies. In one example, to promote off-label use of Neurontin (gabapentin), a medical education company trained speakers to deliver grand rounds lectures on off-label use of anticonvulsants at 70 hospitals.7

Most CME is funded by drug companies, but funding by the medical device industry is also common, according to an international expert panel of 15 surgeons.22 Industry sponsorship is only expected to grow, as academic medical centres and hospitals are expected to cease funding CME for attending surgeons by 2022.22 The expert panel also noted that surgical residents favour free educational opportunities (which are more common with industry funded education).

In June 2019, the European Federation of Pharmaceutical Industries and Associations affirmed that its industry members can organise and provide input to CME activities and fund independent CME activities.23 An alliance between Mental Health Europe and organisations representing healthcare professionals and medical education stakeholders protested that “pharmaceutical companies must not be granted the right to influence the content of medical education.”23

Can bias be avoided?

Some CME accreditors might genuinely want to avoid commercial bias, but their staff are unequipped, unqualified, and unable to detect bias. Not only are they generally untrained in psychology, marketing, or content analysis, but looking for messages that emphasise a particular drug misses the bulk of marketing that doesn’t mention the targeted drug at all. Marketing for a drug starts up to 10 years before a drug comes on the market, with messaging about disease states, mechanisms, and competing products. Because messages in CME foster specific diagnoses rather than specific drugs, they rarely raise suspicion.25

Three instruments have been developed to identify bias in CME activities. One, a nine item questionnaire, asks the audience to assess whether generic or brand names were used, whether patient care recommendations were made without citing evidence or which were inconsistent with the best evidence available, whether harms and benefits were discussed, whether strengths and weaknesses of studies were presented, and whether company logos were present.14 Another assesses the presence of a company logo or product branding, use of trade versus generic names, off-label uses, presentation of evidence based medicine, cited sources, complete and balanced data presentation, whether one product is inappropriately championed over another, and whether the activity enhances medical knowledge.26 The third assesses sponsorship type, percentage of commercial support, responsibility for course logistics, funds management, relationship of the course director to industry, and discussion of off-label uses.27

No existing tool, however, assesses subtle biases. They evaluate the use of brand names, logos, use of trade versus generic names, off-label uses, and overt off-label promotion—mistakes that no self-respecting drug company would make.

Restrict unrestricted grants

“Unrestricted educational grants”—given by industry to medical societies, universities, or medical education and communications companies—should be banned. Unrestricted grants are arguably even more effective as marketing than direct industry funding: having a middleman handle events implies impartiality.

Most of the popular CME providers accept industry support. My team’s analysis of a 2020 ACCME list of accredited CME providers in the US found that 82% of the top 200 most prolific CME providers accept industry funding, and 76% receive funding for advertising and exhibits. The situation is similar in Canada, where 82% of 60 professional medical associations accepted industry sponsorship of CME.29 In the US in 2018, commercial support constituted 26% of total CME funding, accounting for $748m (£528m; €613m) of $2.8bn spent on CME.21 Institutional financial support covered only a median of 40% of Canada’s and 30% of US total expenses.28 (Some US academic medical centres refuse direct industry support for CME, which may explain a recent increase in industry support of medical education and communications companies.21)

Activities with no commercial funding may still be commercially biased, especially when the course director or speakers receive funds from industry. CME managers understand that, if a sponsor is unhappy with a presentation, future business is at risk. Unrestricted educational grants are unrestricted only as long as the funder approves the content. (A personal anecdote: after a talk I gave on industry influence in medicine, the sponsoring drug company threatened to withdraw its “unrestricted” educational grant, and the hospital pleaded with the organiser to apologise to the company for inviting me. She refused).

Sponsored CME is always related to the sponsor’s business. Industry-funded CME is designed to create or expand markets for products that might be unnecessary, inferior, or overpriced. Allowing off-label promotion of drugs for untested, unproven benefits misleads clinicians about both the benefits and risks of targeted products. By affecting medical discourse, industry-funded CME distorts doctors’ understanding of diseases and treatments, and ultimately harms patients.

Biography

Adriane Fugh-Berman is a professor in the Department of Pharmacology and Physiology and the Department of Family Medicine at Georgetown University Medical Center. She directs PharmedOut, a Georgetown University Medical Center project that advances evidence based prescribing and educates healthcare professionals and students about drug and medical device marketing practices. She is a paid expert witness at the request of plaintiffs in litigation regarding drug and medical device marketing practices. Additionally, she serves on the executive board of Physicians for Responsible Opioid Prescribing.

Acknowledgments

I thank Tony Scialli, Joel Lexchin, Douglas Melnick, and Caroline Renko for helpful comments.

Footnotes

  • Competing Interests: AF-B directs PharmedOut, a research and education project at Georgetown University Medical Center that advances evidence based prescribing and educates healthcare professionals and students about drug and medical device marketing practices. She is a paid expert witness in litigation regarding drug and medical device marketing practices. She was the founding co-director of the DC Center for Rational Prescribing, a Washington DC funded model project that provides industry-free CME; she co-directed the programme until late 2019.

References

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