After a particularly intense week in the media, a three-day weekend seems like a much needed respite. However, not everyone is celebrating Columbus Day. For those of you in the office this Monday, we offer a TWTW edition focused on transparency—a theme receiving a lot of attention in politics, policy, and medical journals of late:

  • The New England Journal of Medicine will get a new Editor with the retirement of Dr. Jeffrey Drazen. His successor has an opportunity to provide a clear stance on data sharing, as well as policies on author disclosures of conflicts of interest—areas of frequent criticism for the 200+ year old publication.

  • And speaking of data, the BMJ released a study on industry-funded clinical trials that had at least one academic author. In a study of over 200 hundred such trials, data analysis was done more often by the trials’ funders, rather than academics.

  • FDA Commissioner Scott Gottlieb released a statement on FDA actions “to further deter ‘gaming’ of the generic drug approval process by the use of citizen petitions.” As part of this new guidance, the FDA would be able to reject investigations into petition claims and would publish its rejections in an annual report to Congress as an opportunity to highlight improper use of the petitions.


Pharma news of late is laden with accusations of illegal kickbacks and improper behavior related to patient support services, from nurse educator helplines to copay and reimbursement services. At issue is the question of whether these practices ultimately encourage use of branded drugs over alternatives, potentially even increasing the cost of care or “undermin[ing] medical decision making.”

As the makers of medicines that help treat countless individuals, we know that pharmacos feel a deep responsibility to ensure that a therapy’s benefits are understood, used properly and are prescribed to the right patients. To this end, education and patient support services are both important to medical understanding and also to help patients navigate complex administrative processes to access to these therapies. Training frontline staff about what services are (and aren’t) and developing the appropriate firewalls around objective communications are critical steps in rolling out patient and provider education and support programs. Creating clear guidelines to prevent drug education from being perceived as drug marketing will ensure that clinical educators and prescribers can feel comfortable using and recommending services provided by drugmakers (when appropriate and relevant for their patients).

Gene therapy company Avrobio saw its stock plummet after a data update failed to accurately demonstrate the long term efficacy of its lead pipeline product, a gene therapy for Fabry disease. Avrobio’s press release failed to note that the vector copy numbers or VCN (a key indicator of the healthy transfer of genes) dropped over time, suggesting that the durability of the treatment was lacking. By the end of the day, Avrobio’s stock dropped 52%.

Topline data announcements are evolving to include more details aimed at investors—but that also means that companies are more likely to be called into question for selective reporting. While sharing less-than-positive news about an investigational medicine may temporarily impact valuation, it can also help preserve corporate reputation. Prepare for various scenarios at each major milestone, including how to manage stakeholder expectations. Data milestones are about more than communicating results: they are opportunities to build confidence in company leadership and establish corporate integrity.
Speaking of challenging communications around novel treatments like gene therapies, read what our colleague Leslie Isenegger has to say about the future of pricing for innovative medicines in the October edition of PharmaVOICE.

Until next week.......

-  The Reputation & Risk Management Practice@ Syneos Health Communications

About the Author:

We are a team of healthcare communicators, policy-shapers and crisis response specialists. Drawing upon professional experiences from Congress, CMS, HHS, hospitals, and health technology—and our collective work in rare disease, oncology, diabetes, gene therapy, pain management and infectious disease—we provide unique solutions to the evolving messaging challenges in today’s healthcare industry. We support our clients with evidence-based approaches to preventing pricing pushback, protecting brands from modern activism, establishing and communicating clear policies surrounding expanded access to medicines, and a proactive approach to value frameworks. Our offerings also include product safety, litigation, regulatory risks, ex-U.S. considerations and policymaker investigations.