Today there is an editorial piece in the WSJ about the recent court ruling giving the FDA authority to regulate stem cells grown in culture as drugs.
As a stem cell scientist, I read this opinion piece with interest. Unfortunately it is behind a paywall, but I have outlined and discussed the key issues below.
The article is well written, but very biased too. In fact, I think it completely misses the boat.
Nonetheless, the article carries some weight because it is written by two former employees of the FDA. The WSJ describes the authors in this way:
Dr. Gottlieb is a resident fellow at the American Enterprise Institute and former Food and Drug Administration deputy commissioner. Ms. Klasmeier is head of the FDA practice at Sidley Austin LLP and previously worked as an attorney at the agency. Both authors work with companies developing cell-based therapies.
Note, however, that the authors now are employees of stem cell companies, likely introducing some significant bias into their perspectives.
The article begins:
A recent decision by a federal trial court gave the Food and Drug Administration the latitude that the agency has long sought to regulate our cells as drugs. It could put the brakes on one of the most promising areas of medical research.
This raises a key issue in the field: how much regulation is the right amount for cell therapies? Too much regulation can indeed slow innovation and progress, but too little regulation can lead to patient deaths and injury. Not only is too little regulation clearly harmful to patients, but from a pragmatic point of view it is harmful to the field due to bad press.
Overall, I believe the authors got it very wrong in this WSJ piece.
Not mentioned in the WSJ piece is the critical issue of growing stem cells in culture prior to their transplant back into patients. Cell growth exposes the cells to many contaminating proteins and stresses that tend to make the cells more like cancer cells. The FDA regulation of grown stem cells as drugs is appropriate because grown stem cells are NOT the same thing as the stem cells in the patient’s body prior to isolation and growth. Grown stem cells are inherently more dangerous. They are drugs.
The FDA is not simply meddling in a case where it doesn’t belong as the authors suggest, but rather has legitimate concerns about the stem cells in question. Many leading stem cell scientists view stem cells grown in culture as drugs and in that sense agree with the FDA.
The article also makes the hyperbolic argument that if the decision in favor of the FDA is upheld on appeal, that the FDA will morph into some kind of regulatory monster invading every doctor’s office across the land. Talk about an exaggeration intended to stoke fear into physicians and patients. They write: “If the FDA’s victory is upheld on appeal, then conceivably nothing done as part of clinical practice is beyond the agency’s reach”. Scary, huh?
Imagine instead the alternative scenario of tens of thousands of patients being injected with unregulated, potentially cancerous concoctions of “stem cells” by clinics out to make money…to me that is truly frightening.
To sum up, the authors have presented a very unbalanced, non-scientific argument in this WSJ piece. I think they wrote this simply because the cell therapy companies they work for want less FDA regulation, not to help advance safe and effective stem cell therapies. I see this opinion piece as part of a larger push for stem cell deregulation that I blogged about before. I think such deregulation would have deadly consequences.