December 5, 2020

The Niche

Knoepfler lab stem cell blog

Refuting potential downsides to stem cell drug court ruling

There was a burst of feeling last night in the stem cell community as word began circulating that a federal court had ruled in favor of the FDA defining manipulated stem cell products as drugs.

However, not everyone was pleased with the court ruling.

The clinics most directly affected by the ruling were understandably upset, but interestingly some long-time stem cell advocates also were worried.

They said there are potentially serious downsides to the federal court ruling.

What might be the negative repercussions?

The argument I’ve heard most often is that the direct consequence of this ruling will be that it will, rather than being helpful, actually be harmful because it will drive desperate patients to engage in stem cell tourism by going to other countries for treatment at clinics where patients are at even greater risk.

Is this argument legit?

It is difficult to say if more patients will leave the U.S. as a result of this ruling.

But regardless at its heart this stem cell tourism-based line of reasoning is a false argument because the U.S. must make appropriate laws regardless of the laws of other countries. For example, the U.S. has tax laws that are essential to provide revenue to fund our country. We know the U.S. tax laws lead some folks to take their money to Switzerland or the Cayman Islands to try to dodge U.S. taxes, but nonetheless the U.S. should not give up its tax laws. Similarly the U.S. must require to the best of its ability that medical treatments are safe even if the medical system in the U.S. ends up being far more restrictive than that in other countries. Perhaps this will lead some folks to leave the U.S. seeking more relaxed medical regulatory environments, but at the same time it keeps millions of Americans safer. The tradeoff is worth it.

A second argument is that this court ruling will impede medical innovation related to stem cell technology. I’m not sure I buy this argument either. We need a balance of innovation and safety. In my opinion from my years of experience with stem cells and decades growing cells in culture, once you take cells out of the body and grow them in a dish, they are fundamentally no longer the same any more. Every day cells are grown in culture the less “normal” they become and the more like cancer cells they become. I believe it is appropriate to call stem cells grown in culture “a drug”.

I know a few smart people disagree with me, but I believe they are in the minority.

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