A case for why FDA needs MSB to succeed

Firstly, I need to disclose that I'm not a financial wizard or savvy financial investor. My background is in health and academia with an interest in medical ethics and historical discourse analysis. After parking a good part of my SMSF in MSB, I have periodically checked in with the Hotcopper community and ridden the waves without falling off.

The reason for my first and only post is to offer a hypothesis as to why the FDA (and humanity) need MSB to succeed.

A recent book by John Rasko and Carl Power (2021) named Flesh Made New offers a very interesting history of stem cell regenerative medicine. Beyond an exposè of several charlatans who offered miracle curers, the authors provide a historical account of the flawed, or at worst, fraudulent scientific work that has impacted the reputation of stem cell therapy in the global scientific community. The concluding offer of hope aligns with the type of research that Mesoblast has been conducting. Towards the end of the book, Rasko and Power highlight the global problem of unregulated stem cell therapy clinics, now a multi-billion dollar industry.

As outlined in Master, Mathews & Abou-Enien (2021), the problem with unproven stem cell interventions (SCIs) is that the FDA is unable to regulate every clinic advertising SCIs. This is seen as a global crisis recognised by the World Health Organization (WHO). Similar to Rasko and Powers (2021), the authors highlight how a rogue SCI industry may impact the advancement of legitimate regenerative medicine research (Master et al., 2021). The problem evolving is that some US states have passed legislation to allow patients to access unregulated SCIs in addition to protecting physicians who administer the interventions.

Open access paper - Master, Z., Mathews, K., & Abou-Enein, M. (2021). Unproven stem cell interventions: A global public health problem requiring global deliberation. Stem Cell Reports 16 (6), 1435-1445

Over the last two years, I have considered the postings that have proposed that the FDA are in bed with big pharma and therefore have blocked the progression of approved stem cell interventions. I'm now wondering whether there is resistance from the growing unregulated SCI industry itself that will not benefit from any regulatory progress. When you consider that Biden reversed the withdrawal of WHO funding, this indicates that the current powers are supportive of international collaboration to resolve the growing public health concern around unregulated SCIs. The solution is consistent with the progress and challenges Mesoblast have faced over the last two years. The FDA has set the bar high as they need genuine stem cell organisations to complete rigorous and ethical research. In this context, it is a logical conclusion that the FDA is working closely with Mesoblast and other organisations who, I believe, are on the precipice of making history.

Please note, this is not financial advice as I'm not qualified to offer. Any personal opinion expressed is grounded by many hours of reading.

Best regards, the Chronicler