It’s Monday. It’s fall. And everything is far from certain in healthcare.  But as Enzo Ferrari said, “The future is always in the hands of those who know how to preempt it.”
But, how do you predict American consumer and patient behavior when their own perspectives are split? Well, that’s the million dollar question. Whether its food, health insurance or drug prices, we seem to have conflicting thoughts – both as individuals and as a nation. While there are no easy answers; get ready to dissect our conflicting concerns in The Week That Was: The Cognitive Dissonance Issue.
  • Consumers say “Cut the dihydrogen monoxide!” Um, you mean water? Yes, that’s right folks; a poll found that Americans are fearful of the ingredient dihydrogen monoxide (aka water) in a survey about food ingredients. The poll revealed a dichotomy in American consumer sentiment: 1) we don’t like anything ending in “ide,” but 2) we want colorful, safe foods. Food manufacturers like Mars and General Mills seeking to satiate shifting consumer sentiment have tested everything from purple carrots to beets as natural colorings for foods. The result: Americans don’t like the natural colorings and want Fruit Loops to go back to their former dyes. Sheesh!

  • “Out of whack” is how President Trump surmised the state of American drug pricing during a bill-signing ceremony last week at the White House. POTUS signed two bills aimed at ending the "gag orders" that keep pharmacists from disclosing when a drug may be cheaper without using insurance. The laws allow pharmacists to inform patients of lower prices, but stops short of requiring them to share the information. HHS Secretary Azar said the Administration has "so much more coming."   
  • Low prices = slow growth? Under pressure from the Administration and the public, many large biopharmas have curtailed drug price increases. Yet, a new report predicts the industry could face a period of slower growth as a result. The reason: net price increases – not increased sales -- have contributed 61% to revenue growth of 28% for the 45 largest pharmaceutical products sold in the US over the past 3 years. The report shows the precarious balance of managing consumer affordability while maintaining the stability of a healthcare industry that represents 18% of US GDP. #noteasy

  • Short-term plans win, pre-existing condition coverage loses. In what will certainly be mid-term fodder, Democrats were unable to stop a bid for short-term health plans from moving forward. Streamlined, short-term plans offer a way for insurers to sell bare-bones insurance outside the Obamacare markets for up to one year, rather than the prior 3-month limit. The Administration touts the plans as a cheaper alternative to Obamacare; Democrats fear they gut pre-existing condition protections.

  • It’s complicated, but that shouldn’t get in the way of generic competition according to FDA Commissioner Gottlieb. Last week the FDA issued guidance documents to help spur development of complex generic drugs, such as topical patches and eye drops that have complicated formulation or active ingredients.


Let’s be honest; when the CEOs of biopharmaceutical companies are covered in national media, the tone is typically less-than-complimentary. Some may even argue it’s UNFLATTERING. This is precisely why an article by The New York Times’ Gina Kolata stood out last week. In response to Kolata’s October 2nd story about two heart disease patients denied powerful, cholesterol-lowering PCSK9 inhibitors by their insurers, something unusual happened. The day the story ran, Kolata received an email from Len Schleifer and George Yancopoulos, the respective CEO and CSO of Regeneron, the company that makes one of two PCSK9 therapies. In a telling account, Kolata described how Yancopoulos, offered his personal cell phone number and encouraged the profiled patients to reach out to him. He offered to help liaise with their insurers, and if that didn’t work, give them the drug for free. Yancopoulos added that the barriers which insurers have placed on PCSK9’s are so challenging that even Regeneron’s own employees didn’t have covered access to their company’s own medicine.

It’s nearly impossible to read Regeneron’s response and not come away with the impression that this is a company that genuinely cares about patients. Regeneron has been known for speaking frankly (recall readers when Schleifer confronted Pfizer CEO last year). In this circumstance, frankness worked well. By giving access to the Times, Yancopoulos demonstrated Regeneron’s concern for patients; the challenges insurers are putting in place that can adversely affect patients and the steep investment the company invested in developing its PCSK9. There’s a message here for executives: while it’s nerve-wracking to give reporters deep access, sometimes it may be the only way to convey the facts and your intentions. 


A new report by FirstWord Pharma finds that up to one in three biologic-prescribing physicians who participated in a recent survey recounted that they were exposed to negative word-of-mouth messages about biosimilars over the last six months. Physician respondents said that they were targeted with negative messages about biosimilars, including raising concerns about safety (cited by 58%), efficacy (55%) and efficacy related to extrapolated indications (55%). Nearly half of all physicians exposed to negative information said this had come from originator biologics companies. This news comes on the heels of Pfizer filing a Citizen’s Petition with the FDA last August. That petition accused rivals Amgen, Johnson & Johnson and Roche of disseminating “false and misleading” information about biosimilars in the U.S. (For more, see TWTW, Oct. 1, 2018).

Seven years after the passage of the Act outlining the regulatory pathway for biosimilars, the market remains stifled, potentially costing Americans billions annually. Legislative and regulatory gaps, coupled with legal murkiness, and patent dances, contribute to biosimilars being underutilized. In this opaque environment, competitors will seek to create boundaries on their own. But, the question is, if you manufacture branded biologics AND biologics, how do you engage? If you’re confident in your biosimilar (or biologic) post-marketing safety monitoring, interchangeability and differential naming should not be a threat. Ultimately, a good medicine is a good medicine. However with ~$293 billion in annual global biologic sales set to lose patent protection by 2023, we predict the fight will continue!


Last week, the former head of the NIH Dr. Ezekiel Emanuel gave a lecture on the intersection between bioethics and drug prices, titled “When Is A Drug Price Unjust?” Dr. Emanuel critiqued the pharma industry’s commonly cited reasons for high drug prices; such as costs of research and development, risks associated with drug failure, investment into future medical innovations, and the desire for fair revenue. He argued a lack of regulation and monopolies enable expensive drugs to maintain exclusivity. His solution: value-based price standards relative to average lifetime earnings. He asserted that society should reward drugs that prolong and improve quality of life, but that doesn’t create a disproportionate burden relative to an individual’s average earnings over a lifetime. After some carefully calculated math on Americans lifetime spending, Emanuel concluded any drug priced over $70,015 is unjust.

Dr. Emanuel has long had sharp words about the cost of healthcare. In a Wall Street Journal op-ed about immune-oncology medicines, Emanuel cited a recommendation from the Institute for Clinical and Economic Review that argued drugs should be priced in such a way as to increase total drug spending by no more than GDP growth plus 1.5%. In 2018, that figure would be ~$15 billion, so if 30 new drugs were approved, no single one could add more than $500 million to the total GDP. Our take: that model is unlikely to occur – but concerns about the budget impact of new drugs on private and government payers are here to stay.

Okay, enough economics. Have a good week and see you next Monday.

The Week That Was Team

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.