Following the well-publicized case of a number of Florida patients harmed by a stem cell clinic, the FDA went into hyper drive in its mission to rein in rogue clinics offering dangerous stem cell procedures. Ever since, regulators have made it clear that they intend to clamp down on the nascent stem cell industry come hell or high water.
Meanwhile, a different story has played out in Japan. There, stem cell regulations are nearly nonexistent. The regulations that do exist were implemented by the Japanese government purposely to encourage the development of new stem cell therapies as quickly as possible.
It is easy to look at both regulatory regimes and find both positives and negatives. But neither regime is optimal. Could there be a happy medium between the U.S. and Japanese systems? And if so, is any national government willing to implement it?
A Slow and Expensive System
Here the U.S., regenerative medicine therapies in general have not advanced as quickly as some would like due to a system that is excruciatingly slow and prohibitively expensive. According to the Advanced Regenerative Medicine Institute, companies have to invest millions of dollars and years of research to prove the efficacy and safety of new therapies.
The safety aspect is completely understandable. We do not want doctors treating patients with therapies that could harm them. And yet at the same time, there is always some risk involved. For example, a popular anti-smoking drug that shall remain nameless here comes with a black box warning – the FDA’s most serious warning indicating that use of the labeled drug could be potentially fatal.
It is unclear how the FDA determines an acceptable level of risk. But it seems that, at least in the area of regenerative medicine, the standard is as strict as it can be. As for efficacy, that is a matter of significant debate. Stem cell therapy proponents say patients ought to be able to make their own choices regarding efficacy. Critics say patients need to be protected from expensive therapies that do not work.
A Fast and Loose System
Over in Japan, the regulatory system is a lot more liberal where regenerative medicine is concerned. Just a few years ago the Abe government enacted two separate laws designed to encourage stem cell development in that country. The government made it clear they wanted Japan to become the world leader in stem cell research and development.
Unfortunately, they have created a fast and loose system that is exceedingly difficult to rein in now that it has been allowed to flourish. At the heart of that system is a law that allows individual stem cell clinics to freely operate as long as they can prove the safety of their procedures.
This has led to an explosion in stem cell clinics claiming to treat everything from atherosclerosis to respiratory disease. Once again, critics charge that patients are being taken advantage of by clinics offering treatments that do not work.
Japan’s other law, which is actually a good one, allows therapy developers to bring new therapies to market for the purposes of gathering clinical evidence. Said developers have to gain conditional approval – which is normally based on safety and preliminary efficacy studies – before they can bring their therapies to market. Once conditional approval is given, they have seven years to sell the therapy and simultaneously gather clinical data that proves efficacy.
The U.S. and Japan have drastically different regulatory regimes for stem cell therapies. Wouldn’t it be nice if we could find a system that successfully balances the best of these two regimes?