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. Why CMS’s Aduhelm Decision Matters to You: Part 1

CMS has ruled that Biogen’s Alzheimer’s treatment, Aduhelm, is restricted to Medicare patients “only if they are enrolled in qualifying clinical trials.” This decision throws a monkey wrench in the process of accelerated approvals, an FDA mechanism that has become increasingly popular:

Between 2011 and 2018, accelerated approval requests from drugmakers accounted for about 13% of applications filed with the FDA. And from 1992 through 2020, the FDA issued 253 accelerated approvals, mostly for cancer treatments.

Many commentators have signaled the Aduhelm decision marks the denouement of accelerated approvals. CMS is trying to assuage fears:

“Our recent decision should not be viewed as setting a new direction on therapies that receive FDA accelerated approval,” says Lee Fleisher, chief medical officer of CMS.

Despite CMS’s overture, the underlying premise of their argument is “trust us.” Just as they’re re-writing the rules.

2. Why CMS’s Aduhelm Decision Matters to You: Part 2

There’s a new heavyweight brawl inside the beltway: CMS vs FDA. Even though the FDA granted accelerated approval to Aduhelm, CMS restricted coverage. The Wall Street Journal isn’t impressed. In an editorial, WSJ hits back at the idea of CMS “act[ing] as a political check on the FDA’s decisions:”

Aduhelm is the target today, but cancer and gene therapies could be next…This is the first time CMS has restricted drug coverage in such a way. CMS quibbles with the FDA’s accelerated approval. Yet the agency also plans to require additional studies even for Alzheimer’s treatments that receive traditional FDA approval…In short, CMS bureaucrats will now scrutinize FDA’s clinical judgments. CMS says its “decision facilitates innovation,” but it does the opposite.

3. Winter Is Coming… for AI

Dan Elton of Mass General Brigham makes a list of high-profile AI failures: radiology, skin and breast cancer detection, Watson health. The duds are leading to a “new AI winter.” Of the many problems, one cross-cutting one is that hospitals aren't ready:

Hospitals are not set up to use AI. The most common radiology viewing software programs cannot display AI results. Most hospitals don’t have GPU machines, and sending images to the cloud can be tricky due to HIPPA regulations. EHR and imaging data live on separate systems, so integrating the two is difficult. Despite pushes for standardization, every hospital uses different coding systems and series description conventions for medical images.

4. Think Like a Detective?

Wired takes a stab at answering a common question: how do you navigate online mental health resources? It’s the same conundrum across disease categories, where the burden of separating the good from the bad falls on the shoulders of people living with the illness. 

This won’t do. And Wired’s purported solution falls short:

Think like a detective before you call anyone. Ask yourself what is important to you right now and what you think you’ll need to feel or function better. Then investigate who might be able to help you with that. It may take an assessment by a psychologist or psychiatrist, but it may not. An eating disorder specialist or substance counselor may start you in the right direction if you have bulimia or addiction issues. So be specific when you take stock of all that is contributing to your current dilemma.

This seems unfair to people navigating disease. The burden instead should fall on pharma and advocacy to provide better support, curation, and guidance.

5. Operation Warp Speed: Lessons and Non-Lessons

"Many people are concluding from the success of Operation Warp Speed that big Federal funding can solve other problems at the same speed and scale.”

Wrong, says Canadian economist Alex Tabarrok. On the blog, Marginal Revolution, Tabarrok offers a sober assessment of what Operation Warp Speed did – and did not – achieve:

OWS did not create any scientific innovations or discoveries. The innovative mRNA vaccines are rightly lauded but all of the key scientific ideas behind mRNA as a delivery mechanism long predate Operation Warp Speed. The scientific advances were the result of many decades of work, some of it supported by university and government funding and also a significant fraction by large private investments in firms such as Moderna and BioNTech. It was BioNTech recall that hired Katalin Karikó (and many other mRNA researchers) when she couldn’t get university or government funding. Since OWS created no new scientific breakthroughs there isn’t much to learn from OWS about the efficacy of large scale programs for that purpose.