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. No Gray Matter

 The Alzheimer’s community is seeing red with Medicare – and CMS, the agency that runs it. Time reports how CMS’s controversial decision on Aduhelm left a black mark:

 CMS decided to place any similar future drugs—monoclonal antibodies designed to find and bind to amyloid—under [Coverage with Evidence Development (CED)]. That included lecanemab, which was approved in Jan. under an accelerated approval pathway. Even if lecanemab received traditional approval from the FDA, which is expected at some point this year, the requirement for reimbursement will remain the same: patients must be part of a registry in order to get covered.The author’s conclusion offers no remedy: “if [clinicians] are forced to work in places where there aren’t enough staff to properly care for the patients, a vicious cycle takes hold. It becomes harder to offer good care, and the work becomes even tougher and less satisfying.”

Advocates are crying foul: “‘The FDA has approved other drugs for cancer, AIDS and other things, and CMS has approved them, so why is it dragging its feet on an Alzheimer’s drug?’ says Reinstein, who serves on the board of directors for Voices of Alzheimer’s.”

2. What ChatGPT Means to You

Over 100 million people have joined ChatGPT. It grew far faster than TikTok. What does this mean for the scores of people who turn to the internet for medical advice? An HLG investigation finds no clear answer.

Sometimes, ChatGPT has a strong opinion. Other times, it doesn’t. Below, find a few questions we submitted to ChatGPT and the answers it gave:

Question: I’m feeling sad and tired. Do I have depression?
Answer: As an AI language model, I cannot provide a diagnosis, but feeling sad and tired does not necessarily mean you have depression. However, if these feelings persist for an extended period of time or are interfering with your daily life, it may be a good idea to speak with a mental health professional such as a therapist or psychiatrist…

Question: Are vaccines safe?
Answer: Yes, vaccines are safe and effective. Vaccines have been extensively tested and researched before being approved for use. They go through multiple stages of clinical trials and are evaluated for safety, efficacy, and quality by regulatory authorities such as the Food and Drug Administration (FDA) in the United States…Overall, vaccines have been shown to be one of the most effective public health interventions in history, preventing millions of deaths and illnesses worldwide.

Question: Should I take [brand name redacted]?
Answer: As an AI language model, I cannot provide specific medical advice. [Brand] is a prescription medication used to treat [redacted]…Your doctor can help you weigh the potential benefits and risks of taking [redacted] and determine if it’s appropriate for you…

3. CRSPR, Crypto, and Clinical Trials

  Stop us if you’ve heard this one before: the answer to faster clinical trials may be crypto payments for “biohacking” in a Honduran beach town.

MIT Technology Review investigates the controversial gene-therapy startup Minicircle:

Minicircle aims to fuse elements of the traditional drug testing path with the ethos of “biohackers”—medical mavericks who proudly dabble in self-experimentation and have long hailed the promise of DIY gene therapies. The eccentricities don’t end there. Minicircle’s trials are going ahead in Próspera, an aspiring libertarian paradise born from controversial legislation that has allowed international businesses to carve off bits of Honduras and establish their own micronations. It’s a radical experiment that is allowing a private company to take on the role of the state.

The CEO proceeds with humble ambitions: “I think the potential is radically transformative and beneficial for everyone on Earth…The keys to immortality: we’ve already discovered some of them.”

4. mRNA Heyday

The UK’s NHS and BioNTech have announced an audacious goal for mRNA vaccination – but the target isn’t Covid. It’s cancer. The Guardian explores why mRNA might just be getting started:

 Cancer has long been the ultimate goal of the technology. As part of the partnership, eligible cancer patients in the UK will get early access to clinical trials from autumn 2023 onwards. The hope is that by 2030, these innovative new treatments can be made clinically available to around 10,000 cancer patients.

This is a remarkable development given that not so long ago, BioNTech’s founders – married entrepreneurs Uğur Şahin and Özlem Türeci – were viewed with suspicion by oncologists as purveyors of a technology that was derided as implausible and impractical.

5. Europe’s Generics Jumble: Just Starting

Why is there a shortage of common generic medications across Europe? Reuters asks around:

 
“It's a non-business,” said Biosca-Reig, chief executive of Spanish drugmaker Reig Jofre. While many countries around the world have reported shortages of antibiotics as respiratory infections return with a vengeance after the lifting of pandemic restrictions, the problem in Europe is particularly acute. With prices for generics regulated, many European drugmakers said they are reluctant to expand capacity at a time when the war in Ukraine has pushed up the cost of everything from energy for factories to cardboard for packaging to aluminum for bottle caps - suggesting more shortages are on the cards.