Good afternoon folks,

As tempests raged along our coasts and in the nation’s capital last week, we are all left asking for a metaphoric and literal dose of sunshine and transparen-C. Last week, we witnessed biotech billionaires get charged with fraud for misleading investors and watched Memorial Sloan Kettering’s Chief Medical Officer resign due to habitual lack of financial disclosures. A decade after the Sunshine Act and financial reforms, we seemingly still need a bucket of bleach! Here’s what you may have missed:

  • Apple’s “WATCHing” your heart. Apple received FDA backing for its Watch to conduct electrocardiograms and notifications when atrial fibrillation is detected. The American Heart Association said it will change heart health monitoring, but some argue too much screening can have a negative impact. CNBC’s Meg Tirrell skeptically tweeted that her Apple Watch told her “it’s time to stand” after she’d already been on her feet for an hour. FDA Commissioner Gottlieb replied, “FDA doesn’t regulate that app.”
  • What’s in a name? The answer: millions, according to the SEC. The Southern District of New York alleges Phillip Frost, a long-time biotech billionaire and CEO of OPKO Health, participated in a “pump-and-dump” scheme. The government argues Frost’s associates bought penny stocks, promoted them on investor website articles, and then sold the shares before the bottom dropped out. OPKO and Frost say they adhere to the “highest standards of financial disclosure.” But the SEC says “not so fast,” Frost’s name in the web stories was critical to duping investors.
  • Disrupting healthcare: HHS Secretary Alex Azar made the rounds in New York last week promising the Trump administration will unleash “disruptive” changes in their mission to lower drug costs for Americans. No segment of the industry went unscathed in the Secretary’s comments. Sec. Azar claimed drug companies set prices. But, he also said that PBM rebates could potentially be replaced by discounts patients receive at the pharmacy counter. We’ll stay tuned…. 
And now…The Week That Was.

DISPLEASED is a word that could be used to describe patient groups’ feelings about the recent announcement by CVS Caremark to base its drug coverage decisions on results from the Institute for Clinical and Economic Review (ICER). Last week 95 organizations, mostly patient groups, wrote a letter to CVS CEO Larry Merlo voicing their concerns. They dispute the benefit of ICER’s cost effectiveness studies and fear that use of the quality adjusted life year “QALY” as a metric for determining the cost of medicines will limit people’s access to needed medicines. According to the signers, CVS’s decisions discriminate against the chronically ill, elderly and people with disabilities, because as they assert in the letter, ICER’s model values those patient lives as “worth less than people who are younger or non-disabled." The letter was led by the Partnership to Improve Patient Care, and included involvement of associations such as PhRMA and BIO.
Patient advocacy groups also had words about the Trump administration’s Blueprint-related proposal to include step therapy and indication-based formularies for private plans on Medicare.

In response, CVS defended the use of the ICER reviews, but also said it would meet with the patient groups to consider their concerns. But, the real questions are: 1) Will the backing of CVS Caremark support strengthen ICER’s influence on drug coverage decisions? And, 2) Does this mean ICER will pivot back to reviewing mostly specialty medicines for chronic diseases and minimize focus on transformative drugs for rare conditions?  Time will tell. But life sciences companies should continue to work with patients and champion their voice in discussions of value and access – because making a persuasive case for access is best done working together.

Dr. José Baselga, the Chief Medical Officer at Memorial Sloan Kettering Cancer Center, resigned last week following New York Times and ProPublica reports that he did not disclose his associations with at least a dozen drug companies in notable journals. In aggregate, the payments from pharmaceuticals totaled in the millions. Dr. Baselga acknowledged the “inconsistencies” in his reporting and issued a color-coded list of his articles where he fully disclosed, partially disclosed, or plans to issue disclosure corrections. But the media reports reveal a bigger concern: disclosure is often done on the honor system…and the honor system may be failing. According to an August study of cancer trial authors, one-third of the study authors did not report all sponsor payments.

The reporting by The Times and ProPublica resumes painful conflict-of-interest sensitivities that were waged ten years ago before the Sunshine Act was passed. Today’s public lapses harm trust in both pharmaceutical companies and doctors.  While federal policy only requires drug companies to disclose physician payments for FDA-approved drugs, we advocate for disclosure of all ties, including physician payments related to investigational medicines. Withholding information gives the illusion of wrongdoing when the facts are usually pretty defensible and boring.

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.