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. Art Thou Crappy?

Dr. Janet Woodcock has claimed the NIH is running “small crappy trials.”  The internet was quick to agree. But the data, according to the Substack Maximum Progress, tells a more complex story:

Within each phase of clinical trials, NIH trials are the largest or second largest. Their overall small enrollment average is just due to the fact that they fund more Phase I trials than Phase III. But NIH Phase I trials have a bigger sample size than industry funded trials on average.

2. Just Say No 

The FDA gave thumbs down to Lykos Therapeutics' proposal for MDMA-assisted therapy for PTSD. Alex Tabarrok, a regular critic of the FDA, suggests the decision is “a textbook example of making the perfect the enemy of the good.” He elaborates: 

Holtzheimer [Deputy Director for Research at the National Center for PTSD] seems to think that treatments spring from the lab perfectly formed like Athena springing from the brow of Zeus. Indeed, Holtzheimer suggests that treatments should be kept in the lab until they are perfect. News flash: there are no perfect treatments–no drug or device in use today is completely known to be safe, fully effective, and used at its optimal efficacy. Not one. If we follow Holtzheimer’s counsel, we will never approve a new drug.

3. Just Say Yes – to Clinical Research Standards

Andrew Penn, a psychiatric nurse practitioner, laments the FDA’s decision on MDMA. But he sympathizes with the rationale. He offers a path forward for better clinical data set – and a new mindset for the psychedelics crowd:

There was a seductive assumption made in these early days – MDMA assisted therapy works, and we just have to prove it to the FDA (rather than the academic and dull task of disproving the null hypothesis, which would be “MDMA-AT does not work for PTSD”).

This “seductive assumption,” Penn argues, set the study up for failure:   

Clinical research must have different priorities than clinical practice. The clinical practitioner wants to help patients, the clinical researcher needs to objectively answer a question, hence the use of placebos, standardized methods (which may not be optimum to what a patient wants or needs), and whenever possible, objective ratings of clinical change.

4. Pharmacy Deserts 

Over 7,000 pharmacies have closed in the US since 2019, according to a study cited by Fortune. These closures are creating “pharmacy deserts” that hurt the most vulnerable: 

Drugstores have become bigger sources of care in recent years, sometimes by design or necessity — especially for customers who work multiple jobs and can’t easily get to a doctor…They’ve also encouraged pharmacists to counsel patients more on managing conditions like diabetes or high blood pressure…“There is no easy access to a doctor’s office. You need an appointment. They have limited hours,” one store owner and pharmacist said. “So any time any child or adult — whoever is sick — where are they going to go first? To the pharmacy.”

5. Not Hiring

Tough news for pharma job seekers. Big pharma, small biotech, and everything in between have hit the brakes on hiring. What gives? Chemistry World offers a few reasons, but patent losses are leading the slowdown:

‘A lot of firms are facing some patent losses and some areas where they need to restructure and optimise,’ says Damien Conover, head of health equity strategy at Morningstar…There has also been a shift due to the maturity of the biopharma sector. “Biotechs look a lot like big pharma now, because they’re facing a lot more patent losses than they had in the previous decade.”