HLG

Dear clients and friends: Given your interest in health and medicine, we would like to share with you our collection of the most interesting perspectives on our industry's trends and developments. We are happy to share them with you — and hope you share your thoughts with us.

1. Bud Light Hangover

Following Bud Light and Target, might a pharma company be next to experience the “figurative gun” of the American right? Vox traces the success of anti-woke protests and concludes with a message that may keep pharma bosses up at night:

 In May, influential right-wing commentator Matt Walsh was quite open about the strategy on the platform formerly known as Twitter. “We don’t need to [boycott every woke company],” he wrote. “Pick a few strategic targets. Make them pay dearly. That’s enough to make wokeness a lot less appealing to the corporate world. Stop trying to bring down the whole line of dominos at once. Start with one, and then the next.”

Pharma may seem an unlikely target, but so did Disney: “If you are a CEO sitting in your office today contemplating how you’re going to approach political and cultural issues, the threat of conservative activists coming for you has to be in the back of your mind. As much as your employees, customers, and even perhaps personal politics may be pushing you to the left, there’s a risk that your firm could be next.”


2. Show Me the Money

Drug development needs incentives. When markets don’t incentivize, grants and prizes do. But what happens when none of these encourage organizations to develop new therapies, like vaccines for the world’s poor? The blog Works in Progress reviews the sluggish history of the malaria vaccine to make a strong case for “Advance Market Commitments”:

AA standard Advance Market Commitment (AMC) is a promise to subsidize the future purchase of a new vaccine in large quantities – if it’s invented – in return for the firm charging customers close to marginal cost (that is, with only a small mark-up). 

Let’s break it down. The subsidy incentivizes research by compensating innovators for their fixed cost investments in R&D and manufacturing capacity. The commitments to buy a certain quantity at a certain price ensure the vaccine is affordable and widely available. The subsidy is conditional on a co-payment (this is the part that is close to marginal cost) from governments in low and middle income countries – without it, the developer receives nothing. This incentivizes firms to develop vaccines countries will actually use, not just those that meet technical specifications.

3. Our Favorite Study

More companies are winning approval from the FDA with single studies and less public disclosure. Two researchers find a steady trend following the federal 21st Century Cures Act: 

Of the 37 drugs approved by the FDA in 2022, 24 (about 65%) were approved based on a single study. Four of the 37 drugs (about 11%) reported three or more studies before approval. Roughly half of the 413 studies available for analysis were classified as randomized clinical trials, while results were publicly posted on ClinicalTrials.gov for only 103 of the 413 studies.

In 2016, prior to the Cures Act, only four of 20 novel drugs (20%) were approved based on a single trial…Despite drugmakers completing an average of 5.82 studies per drug prior to FDA approval, results were disclosed on ClinicalTrials.gov prior to approval for only 1.42 studies on average.

4. Revolutionary Times?

Are we living through a scientific revolution? Science and medicine historian, Benjamin Breen, thinks we might be. You’re excused for missing the memo:

People living through scientific revolutions are usually unaware of them — and, if they are, they don’t think about them in the same way that later generations do.

Breen backs his assertion with compelling evidence – much of which might build the foundation for a life sciences business boom. Here are his Q1 highlights:

January: Positive results from a clinical trial of a vaccine for RSV; OpenAI’s ChatGPT enters wide use.

February: A major breakthrough in quantum computing; announcement of a tiny robot that can clean blood vessels; more evidence for the ability of psychedelics to enhance neuroplasticity; major developments in biocomputers.

March: OpenAI rolls out GPT-4; continued progress on mRNA vaccines for cancer.

5. Dr. Detective’s Long Shot

Long COVID has landed in an unhappy middle-ground: some suffer from it, others deny it exists, doctors don’t know what to do about it, and most everyone wants to move on. Enter Dr. Lisa Sanders, whose clinic at Yale is trying to sort it all out. The Intelligencer reports her efforts are part wonk, part Sherlock Holmes:

 Hearing patients’ complicated problems and solving them was her sweet spot, the talent and interest upon which she had built a storied career. Now 67, she has long been known as the Arthur Conan Doyle of medical diagnosis, “a paragon of the modern medical-detective storyteller,” as the celebrated surgeon Atul Gawande once described her. In addition to teaching internal medicine at Yale, she writes “Diagnosis,” a monthly medical-mysteries column for The New York Times Magazine, which was the inspiration for the long-running television series House. She has written two books on diagnosis and in 2019 was featured on a Netflix docuseries also called Diagnosis. Sanders, energetic and brusque, had been casting about for her next challenge. And here, unexpectedly, it was.