14.06

2017
Medical education versus promotion – is the line ever blurred?
Written by Dr Niamh O’Reilly

 

In an ideal world, healthcare professional (HCP) education about pharmaceutical and medical device therapies is always distinguishable from promotion. Yet the reality is that medical education and promotion can sometimes cross paths such that their distinction becomes blurred. Indeed, one could argue that medical education conducted by pharmaceutical and device companies is a form of promotion as the reality is that there is ultimately a product to sell. On the other hand, since the pharmaceutical/medical device company researched and/or developed the product, it can also be argued that the company is amongst those best placed to educate HCPs about that product.

Medical education and promotion are quite different activities:

  • Medical education is an activity providing accurate, balanced and scientifically valid information about a medical condition or therapy without any specific promotional claims.
  • Promotion of a therapy includes any representation that is persuasive and conveys the positive attributes of a product to encourage its prescribing, use, sale, purchase or supply.

However, when does the line between these two distinct activities become blurred? The following three cases, adjudicated by the Medicines Australia Code of Conduct Committee (“Committee”), help to shed some light.

Case 1. Selective data as medical education

Scientific or technical information provided to HCPs should be fair, accurate and balanced, particularly comparative information between therapies, to support clinical decision-making. Yet what if a pharmaceutical company’s Medical Liaison team was to distribute an email to HCPs containing selective excerpts of efficacy and safety data from a regulatory agency assessment report to favourably compare its therapy with a competitor product? This was the case where the selective extraction of data in an email was consequently considered by the Committee to be unfair, unbalanced and misleading to HCPs.(1) Being extracted data, it was without relevant context and omitted key report information about the competitor therapy, The selective email information thus did not accurately reflect the equivalent report content and would likely have the effect of discouraging use of the competitor therapy, while encouraging use of the company’s product. Although the full report was provided in the email, the Committee concluded the email content was promotional information and not medical education as it provided selective data to discredit the competitor therapy.(1)

Case 2. Off-label information as medical education

Companies are responsible for ensuring therapy content at medical educational meetings aligns with the approved Product Information and to brief HCP speakers accordingly when presenting at these events. However, at one meeting (one of a series of educational meetings sponsored by a pharmaceutical company) the international HCP speaker presented study data on the long-term use of a drug for up to 12 years, although its approved treatment duration was 12 weeks.(2) Moreover, the data presented was for a different compound of the drug moiety to that approved in Australia, which was indicated for a maximum of 12 weeks’ use. The Committee concluded the educational content focused on a product not available in Australia, although containing the same drug moiety, and would encourage off-label prescribing for long term use which, in turn, had potential safety implications for patients. In this case, educating on the long-term use of an unapproved compound of the same drug moiety was tantamount to off-label promotion of the long-term use and associated safety of the approved product in Australia.(2)

Case 3. Manufacturing tour as medical education

The primary objective of HCP attendance at company sponsored medical education events is to enhance medical knowledge and the quality use of medicines. Companies must be able to justify the event’s educational content and its relevance to HCP attendees’ area of expertise. However, would an overseas manufacturing facility tour organised (and sponsored) by a pharmaceutical or medical device company qualify as necessary HCP education? On the surface, one of two extremes could be argued – either it is education overkill or an example of promotion disguised as medical education.

Yet it was neither of these extremes in a case adjudicated by both the Medicines Australia Code of Conduct Committee and Appeals Committee where a pharmaceutical company had organised for a group of HCPs to visit its biotechnology manufacturing facility following their attendance at a nearby third party scientific meeting.(2) The tour aimed to provide HCPs experiential understanding of the manufacturing process – its complexities, challenges and quality standards – for a specific biological therapy by seeing it first-hand. This would help to build their confidence of the process, as well as knowledge of potential patient reactions to the therapy’s complex protein molecules. The HCPs would also benefit from interacting with the R&D and manufacturing process personnel, which in turn could benefit patients. The Appeals Committee accepted the appropriateness and relevance of the tour for these reasons and so overturned the Code of Conduct Committee’s view that the purpose was to promote the company’s biological product, encouraging HCPs to continue prescribing and recommending. Of relevance is that there was no biological substitute for the company’s product, while other companies had held similar manufacturing plant tours for HCPs in educating on the complexities of biological therapies.(2)

Erasing the blur

The above mentioned cases show that the line between medical education and promotion is not always clear. Rigorous scrutiny in the planning of medical educational activities and content – ideally via a quality control process involving various stakeholders who can provide multiple perspectives – is therefore important to minimise the risk, intentional or unintentional, that the education becomes, or is perceived to be, promotion.

These cases also illustrate the importance of context. In Case 1, the selective use of data emailed to HCPs, which was non-contextualised, showed how incomplete information can easily morph from education to promotion, whereby the data becomes distorted, biasing one therapy over another. In Case 2, where an educational meeting focused on the long-term treatment duration of an unapproved compound with the same drug moiety as the approved product indicated for short-term use, HCPs will likely be encouraged to prescribe the latter for long-term use. Whether this effect was inadvertent or not, the meeting’s educational value was consequently outweighed by the promotional goal. Case 3 shows that even when an educational activity is consistent with industry standards and benchmarks and there is a broader relevant context to justify it – in this example the need to provide HCPs experiential learning about a complex biologicals manufacturing process that could not realistically be provided another way – the (mis)perception of promotion disguised as education may still arise.

Medical education and promotion are both key activities conducted by pharmaceutical and medical device companies. Our dedicated Medical Affairs team at CRC is well equipped to help plan and implement a wide range of impactful, yet compliant educational and promotional review activities for healthcare industry clients, ensuring the line between medical education and promotion is clear.

References

  1. Medicines Australia. Code of Conduct Annual Report 2013-2014.
  2. Medicines Australia. Code of Conduct Annual Report 2014-2015.