It’s very clear that there are a great many doctors in the United States, perhaps even a majority, who believe the Food and Drug Administration (FDA) is sometimes guilty of abusing its authority and of assuming powers it doesn’t have.
The controversy swirling about ivermectin is the most popular current example of FDA overreach, but it’s hardly the only one. The agency’s job is precisely defined within relatively narrow boundaries: to approve drugs and treatments for use with humans or animals. It isn’t their job to practice medicine or to advise anyone on how to practice medicine.
That seems like a pretty bright line. But, as recent coverage on the pages of The Epoch Times and other outlets has shown, it’s a line the agency expends a great deal of time and energy dancing around.
They simultaneously maintained that the above examples, and many more like them, didn’t constitute medical advice. Because, you know, who’s going to consider a statement made by the federal agency charged with evaluating drug safety as “advice”? It was all about transmitting “information” in a lighthearted way! Yes, that’s it! Who knew that some people would actually feel compelled to restrict their actions based on that “information”?
Using an FDA-approved drug for a purpose for which it wasn’t originally intended happens all the time. It’s called “off-label use” in the profession, and it’s one of the ways that the practice of medicine advances. Once a drug or treatment is deemed safe on its own, the FDA is out of the picture. It determines whether the drug can be used, not how it’s used. The latter part is up to medical professionals in the field.
“Once we saw the effects, myself and many others started prescribing ACE inhibitors for use to treat heart disease,” Dr. Raymond Pierce of Rapid City, South Dakota, told me. “We often used dosages beyond what FDA initially envisioned, but that didn’t matter. The FDA job is to say that a drug does or doesn’t present a risk. It has no legal authority or professional expertise to evaluate the value of any drug in a practical context. That’s up to individual health care professionals.”
That’s how the system is supposed to work. In practical terms, the FDA is there to approve the design of a tool, not to tell the mechanic how to use it. That worked in the case of ACE inhibitors. It quickly became a standard treatment for heart disease and has proven remarkably effective. This is but one example of how off-label use provides an important avenue for medical advancement.
FDA overreach is of particular importance to Dr. Pierce, a champion of regenerative medicine. He’s the owner of the Dakota Stem Cell Institute and chairman of the Investigational Review Board of the International Cell Surgical Society, a board on which I also sit. Both organizations help to develop treatments for a variety of ailments using mesenchymal “adult” stem cells. These are stem cells present in one’s own body that are usually harvested for treatment purposes from a patient’s own fatty tissue. Unlike treatments using embryonic stem cells, these regimes don’t introduce any foreign matter into a patient’s body, just as a skin graft uses one part of the body to help heal another part.
This type of regenerative therapy has proven remarkably safe, and all signs suggest that future advancements will be plentiful and remarkable. It’s been used to treat degenerative diseases such as arthritis. It’s been used to improve eyesight. It shows promise as a treatment for Parkinson’s. The biggest obstacle to further progress in the field? The FDA. Bureaucrats at the agency claim that removing and reinjecting a person’s own stem cells creates a new “drug,” and therefore the procedure falls under its jurisdiction.
In 2018, the FDA filed a lawsuit aimed at stopping the California Stem Cell Treatment Center from performing the procedure. Last fall, Judge Jesus G. Bernal of the Central District of California unequivocally ruled in favor of the defendants, declaring that the procedure doesn’t create a new prescription drug. The FDA was directed, in legal terms, to butt out.
There appear to be a couple of forces at work here. One is the tendency of people put in positions of authority to believe that the position automatically confers expertise. This is especially prevalent in the public sector. I see this all the time in my profession, in which I have far more personal experience and expertise in atmospheric chemistry and air quality regulation than 95 percent of the folks I deal with at the Environmental Protection Agency. Not all of them claim omnipotence and infallibility, but a disturbing number do. In that sense, FDA overreach is the same story, just a different agency.
More disturbing is the other apparent factor: crony capitalism.
“There are some big pharmaceutical companies who do not want regenerative medicine to succeed,” Dr. Pierce said.
“When people can cure, or even mitigate, chronic and degenerative conditions using their own stem cells, that’s money out of a drug company’s pocket. It’s naïve to believe that pharma lobbyists don’t whisper in the ears of decision-makers at the FDA, and even more naïve to believe that those officials are immune to that combination of pressure and persuasion.”
There’s nothing wrong with having a Food and Drug Administration. The FDA fulfills an important purpose: ensuring that drugs and treatments are safe as they’re introduced into the health care system. How those drugs and treatments ultimately fit into that system isn’t part of the FDA’s mission and, as this developing story continues to show, is beyond this agency’s competence.
