TWTW team took some time out of our Monday schedules to pass around a pair of eclipse glasses and soak up the (lack of) sun. We were in good company at New York City’s Highline and across the country. Eclipse watching on Monday incurred a drop in workplace productivity of ~$700 million in “missing outputs.”
Back on Earth, President Trump’s speech on Afghanistan, musings about a government shutdown and anti-media remarks at a rally in Phoenix eclipsed the user fee agreements legislation, which he signed into law last week.
While the Administration remained relatively quiet on healthcare, our team kept an eye on a number of stories about opioid “pledges,” top-line data communications and, as always, drug pricing.
Read on for The Week That Was…
The CATCH-22 With TOP-LINE DATA CommunicationsWhat data to disclose? What data not to disclose…? And, how do you best communicate it to set transparent expectations? These are just a few of the questions facing developers when approaching top-line data disclosures. The Wall Street Journal recently reported that since 2015, there have been many instances of major stock price fluctuations at the time drug developers published top-line clinical data results – but the same company was punished or rewarded by the market months later, when the full data was released. Federal securities laws require the sharing of “material” facts with the public. This often includes whether or not an investigational therapy met its primary endpoints. But increasingly, companies are opting to disclose topline findings shortly after a clinical trial closes and “locks” – yet they hold the full results for publication in medical journals and conferences where it can increase awareness among physicians. However, the content and time between these top-line and full data disclosures is starting to raise concern, particularly when the full data is delayed. Investors are forced to read the “tea leaves” with only top-line data, which may not be truly representative of a medicine’s value.
Media scrutiny over companies that “oversell” a therapy’s efficacy and safety in top-line data communications has been increasing, as has the legal backlash from investors who feel “misled” by top-line results. Cross-functional, internal alignment and external expectation setting has never been more important surrounding key milestones leading up to approval. Healthcare executives pouring over their topline data disclosures need to ensure they are appropriately setting investor expectations. Our advice: scrutinize how every word of a top-line data press release will be construed by investors – and make sure you’re painting a realistic picture based on what’s known… or face the consequences when the full data is communicated!
OPIOID PLEDGES GET RENEWED COVERAGE
In 2016, we saw a round of opioid “pledges”—healthcare companies committing to proactive efforts to curb the epidemic. Media this week reported on the progress of a number of these efforts. Anthem reported that they have already reduced filled opioid prescriptions by 30%—a goal originally set for 2019. In response to a prescription-cap, physicians in Maine are reporting that they have reduced the number of pain patients on opioids by half. And Express Scripts announced an expansion of its 2016 pilot program to reduce early exposure to opioids and prevent abuse, with a new nationwide program that would limit the number and strength of opioid medications that doctors can prescribe to first-time users.
The healthcare industry certainly isn’t new to pledges or social contracts; a number of organizations have made similar assertions about their efforts to address drug pricing. While these announcements often garner a spike in good press, our testing shows that unless a company comes out with something really novel (or incredibly aggressive, like Intermountain Healthcare’s pledge to reduce opioid use 40% by 2018), the overall impact of these pledges on public perception is minimal. And for some, such as Express Scripts, these announcements raise questions about the wisdom of cutting access to patients with no other alternative in place.
This week’s news serves a reminder that debate about stakeholder roles in the opioid epidemic is not going anywhere. While making a pledge, setting a cap or announcing any other kind of policy may not be necessary, companies should consider their position on the issue, and be ready to communicate it if needed.
AETNA UNDER FIRE FOR SNAIL-MAIL DATA BREACH
This week Aetna is facing backlash—and potential lawsuits for a letter mailed to about 12,000 of their members with HIV. The mailing included text with the patient’s name and a reference to a prescription for HIV in the window in the envelope. Coverage of the incident notes that recipients were “devastated,” and that some had their families learn about their status for the first time through the mailing. The Legal Action Center and AIDS Law Project of Pennsylvania have requested a cease and desist for the mailings and many have filed complaints with the U.S Department of Health and Human Services. In a statement, Aetna said: “We sincerely apologize to those affected by a mailing issue that inadvertently exposed the personal health information of some Aetna members. This type of mistake is unacceptable, and we are undertaking a full review of our processes to ensure something like this never happens again.”
While much attention is paid to protecting patient privacy from electronic data breaches, Aetna’s misstep demonstrates the importance of secure patient communications in all forms. Careful attention to detail is required regardless if messages go out via physical mailings, email (including detail in subject lines), responses to patient inquiries via voicemail messages, and correspondence regarding patient assistance programs. Having appropriate safeguards in place is a must—as is having a nimble issues management strategy to identify and stop problems before they worsen.
We’ll be off next weekend for Labor Day, but will be back in your inboxes the following week.
– The Reputation & Risk Management Practice @inVentiv Health Communications