Cheap Seats 2023 By Rich Trzupek

Playing Doctor - 09/06

By Rich Trzupek
  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 is sometimes guilty of abusing its authority and of assuming powers it does not have. The controversy swirling about ivermectin is the most popular current example of FDA overreach, but it is hardly the only one. The agency’s job is precisely defined within relatively narrow boundaries: to approve drugs and treatments for use with humans and/or animals. It is not 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 about which the Agency expends a great deal of time and energy to dance about. After tweeting that people should “stop it” (“it” being using ivermectin to treat Covid), backing that up with their expert opinion that humans are neither cattle nor equines, and after maintaining a web-page that essentially told readers they were morons if they used ivermectin, the FDA was forced to admit in court that they had no authority to offer medical advice. They simultaneously maintained that the above examples, and many more like them, did not constitute medical advice. Because, you know, who is going to consider a statement made by the federal agency charged with evaluating drug safety “advice?” It was all about transmitting “information” in a light-hearted way! Yes, that’s it! Who knew that people would actually feel compelled to restrict their actions based on that “information?”
  Using an FDA approved drug for a purpose for which it was not originally intended happens all the time. It’s called “off label use” in the profession and it’s one of the ways that medicine makes advances. Once a drug or treatment is deemed safe on its own, FDA is out of the picture. They determine if the drug can be used, not how it’s used. The latter part is up to medical professionals in the field.
  The progression in the use of ACE inhibitors provides an object lesson. When the FDA first approved the use of angiotensin-converting enzyme inhibitors (ACE Inhibitors) for use with humans, the medication was meant to target hypertension. Physicians prescribing ACE inhibitors soon discovered an unexpected benefit. The conditions of patients who were also diagnosed with varying levels of heart disease and heart failure markedly improved when prescribed ACE Inhibitors. The boots on the ground – individual physicians taking care of individuals – soon realized they were on to something, even if the FDA paper-pushers in “high command” didn’t have a clue.
  “Once we saw the effects, myself and many others started prescribing ACE inhibitors for use to treat heart disease,” said Dr Raymond Pierce of Rapid City, South Dakota. “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 does not 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 is 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 over-reach is of particular importance to Dr. Pierce, a champion of regenerative medicine. He is the owner of the Dakota Stem Cell Institute and Chairman of the Investigational Review Board (IRB) of the International Cell Surgical Society (ICSS). 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 typically harvested for treatment purposes from a patient’s own fatty tissue. Unlike treatments using embryonic stem cells, these regimes do not 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. The biggest obstacle to 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 does not 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. Call it “the Fauci effect.” 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 EPA. Not all of them claim omnipotence and infallibility, but a disturbing number do. In that sense FDA over-reach 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,” 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 is nothing wrong with having a Food and Drug Administration. The FDA fulfills an important purpose: ensuring that drugs and treatments are safe as they are introduced into the health-care system. How those drugs and treatments ultimately fit into that system is not part of FDA’s mission and, as this developing story continues to show, is beyond this agency’s competence.
  Email: richtrzupek@gmail.com