Patient Opinion Leaders – How Much Transparency Do We Need?

Ariel Katz
Feb 9, 2021

If a pharma sales rep buys a physician or a nurse practitioner lunch, the healthcare provider has to report it under the Sunshine Act – unless it amounts to less than $10. If a pharmaceutical company asks a medical expert to speak on their behalf at a medical conference and pays their way – the expert has to report this and a record of the expenses is entered into the Open Payments database. In short, every payment or “transfer of value” (e.g. a meal or gift) above $10 and/or more than $100 per year in total would need to be reported.

These reporting requirements were introduced to create transparency: now everybody can find out, with a few clicks of their mouse, what type of freebies their physician has been treated to, and by whom. Originally limited to physicians and teaching hospitals, the provisions of the Sunshine Act were expanded to include mid-level medical professionals such as physician assistants and nurse practitioners in 2018.

Enter a new kind of influencer in the healthcare realm: the patient opinion leader (POL). POLs are generally patients or caregivers of patients who have educated themselves about their disease and have built large networks – mostly using social media and blogging – of fellow patients. POLs share knowledge, engage in dialogue with other patients, and facilitate the exchange of information among their followers.

Increasingly, POLs are sought out by pharmaceutical companies who value both the insights and real life experience the POLs can share and the large number of patients they have access to through their networks. This access can prove invaluable for pharma companies looking to recruit clinical trial participants, especially for rare diseases, or get feedback, e.g. in the form of surveys. One POL, putting out the word to their community, can dramatically shorten recruiting times for clinical trials or improve response rates to a survey saving the pharma company a lot of money and time. Savings they are willing to pay for.

Compensation and Transparency

Payments to POLs raise the same legal and ethical questions as payments to medical advisors and experts such as key opinion leaders, specifically around transparency. In this post, all we will do is point out that the Federal Trade Commission has published “Guides Concerning the Use of Endorsements and Testimonials in Advertising” that elaborate on topics such as who needs to disclose what and how. These guidelines cover endorsement of products and services, however, just putting the information out that “Company X” is looking to recruit patients for a clinical trial or to fill out a questionnaire is not an endorsement or testimonial and with that is a different story.

In addition to legal issues, there are ethical questions around disclosure. Should a POL disclose their relationship with a pharmaceutical company, specifically, whether they received payments. POLs might choose to disclose that information voluntarily to their communities to avoid eroding the trust they have built in case the information should somehow become public. However, POLs might feel that disclosure of a payment or an in-kind contribution, such as a paid trip to a conference, is not necessary and that it is implied and generally understood that they would be compensated.

POLs also have to ask themselves how far they are willing to go: is helping to find people who participate in a survey acceptable but is letting them know about a clinical trial looking to recruit patients a step too far? Where is that line? Is it only acceptable to help recruit others for something one has participated in and can therefore vouch for, or is it just as acceptable to support activities the POL would not participate in themselves? Is it okay to take money at all and if so, does it matter whether the money goes towards a vacation or is used to improve the website or social media outreach to other patients?

On the other side is the pharmaceutical company and the question about their disclosure. If they invite a POL to participate in a conference, write a blog, or help recruit study participants shouldn’t they disclose this fact and shouldn’t the public be able to see what payments were made and to whom regardless of whether the Pharmaceutical companies works with the POL directly or through a service provider?

POLs are a relatively new addition to the already complicated healthcare landscape and time will show what level of transparency should be required and whether we will need to extend the sunshine Act further to also include “payments and transfer of value” to POLs.