Tuesday, September 05, 2023

“The FDA is Not a Physician.” Life, Liberty, and the Pursuit of Economic Development

The Sound of Freedom

The bad news is that an ongoing court case in Texas offers a window into the workings of a not-so-benevolent health bureaucracy, more interested in having its way than in helping patients.  The good news is that this meddling is backfiring, and so the same window could light the way to genuine health reform and more personal freedom. 


The case in question concerns the U.S. Food and Drug Administration’s efforts to squelch the treatment of disease.  That’s right, the FDA has been playing national nanny, intruding between patients and their doctors.  Indeed, the agency has been proud of its efforts, basking in praise from the medical establishment and the mainstream media.  Yet this troika-combine—bureaucratic, technocratic, and journalistic elites, sharing a superiority complex—has hit roadblocks: first, popular resistance, and second, a slapdown from a high court. 


You see, the doctors that the FDA had been targeting fought back in court, mobilizing public support along the way.  And on September 1, having reviewed the case, a three-judge panel from the Court of Appeals for Fifth Circuit—which covers Texas, Louisiana, and Mississippi— declared, “The FDA is not a phsyician.”  That’s the sound of freedom, potentially, far beyond this specific case. 


The judges were responding to the FDA’s campaign of harassment against three physicians, Robert L. Apter, Mary Talley Bowden, and Paul E. Marik, all of them MDs.  The three doctors had prescribed—and, even worse in the eyes of Big Health, publicly advocated for—ivermectin as a treatment for Covid-19.  You know ivermectin: the drug the MSM routinely dismisses as a “horse dewormer,” never minding that there’s a human version of the drug (long ago described as a “wonder drug,” in fact), which has an astonishing variety of uses.  And yet in the elite view, ivermectin is the signature Covid treatment for right-wing, Trumpy people, and so it can’t be good.  According to this politicized and polarized thinking, the main goal seems to be, not maximizing public health, but rather, never giving them a win.   Yes, there’s the medical struggle against Covid, and there’s the class struggle against wrong think by the proles—and which do the elites think is more important?  


The Rule of Dogma 


We might pause to observe that organizations and interests tend to develop dogmas.  That is, some belief system that defines the institution, and imbues its adherents with a sense of mission and passion.  When such dogmas emerge in a bureaucracy, zealously believing bureaucrats can be quite insistent on getting their way. That is, the desire to win the point gets the better of any rational cost-benefit analysis.  Depending on the issue, we can like or dislike the dogma, but no matter where we stand, we should at least recognize that dogma imposed on others is the opposite of freedom.  And so it is that Dogmatic Big Health has come to oppose most Covid treatments.


Broadly speaking, liberals, Democrats, and blue states have supported masks and vaccines to combat Covid.  Indeed, four years after we first heard of the virus, masks and vaccines are still the favored “blue” approach.  By contrast, conservatives, Republicans, and red states, opposing masks and vaccines, have supported Covid treatment as might be needed. 


So we can see the conflict: In the mind of Blue, if you follow its prescription (vaccines and masks), you won’t get Covid.  And yet if you reject vaccines and masks, blue thinking does, there’s something wrong with you, and so if you get the disease, well, maybe you deserve it.  Or at least, your getting Covid will encourage the others to mask up and get vaxxed. 


At the same time, since Red mistrusts Blue, it increasingly rejects its masks and vaccines; instead, Red wants options for Covid treatment.  Without much help from Blue, Red has been searching around for the best, as well as least expensive, treatments.  Enter Drs. Apter, Talley Bowden, and Marik, who are just three of thousands of physicians, and other healthcare providers, who have been scanning, experimenting, and prescribing.   


Interestingly, one of the few Covid treatments that Blue’s bureaucratic enforcer, the FDA, approves of is Remdesivir, sold as Veklury, made by Gilead, a pillar of Big Pharma and thus trusted by Blue. Veklury’s sticker price, for the prescribed five-day treatment, is $2,340.  That’s a lot of money, although, of course, typically insurance companies, or U.S. government agencies, end up footing the bill, which is often negotiated downward.  


Yet in point of fact, Blue doesn’t mind paying big money for approved Covid treatments. The feds, after all, spent at least $3 billion on ventilators, which seem to do more harm that good, and yet nevertheless were a part of the approved orthodoxy.  Why this free spendingness?   Because Blue seems more interested in maintaining its orthodoxy: Use only the methods and treatments that we recommend.  So that meant ventilators for a while (until it became too obvious that ventilators were actually hurting patients) and now, Remdesivir/Veklury.  In this ortho-maintenance effort, the FDA is joined by liked-minded federal agencies, including the Centers for Disease Control and Prevention (CDC) the National Institutes of Health (NIH), and the major federal paymaster, the Centers for Medicare and Medicaid Services (CMS).   


These four agencies, as well as myriad public, quasi-public, and private allies, share a common view: They are correct in their recommendations, because, after all, they are the experts.  So that means treatments coming from on high are right and treatments favored by those down below are wrong, wrong, wrong, not just medically, but morally.  These lower types of treatment, to be shunned, include not only ivermectin but also hydroxychloroquine, vitamin C, and zinc—a fuller list can be found on the website C19 Early.  Interestingly, these hoped-for treatments tend to be generic drugs, or even dirt-cheap commodities; that’s one more reason why Red is so interested in them: because if it’s exploring unorthodox ideas, Red will get no financial help from Blue.  Indeed, Blue will even attack Red. 


Dogmatic Action 


Blue has been trying to crush Red, seeking to squelch the thought that Red could know what it’s doing Covid-wise.  One tool for squelching has been censorship on social media, and yet in addition, the FDA has taken to social media to deliver its own message.  Back on August 21, 2021, the FDA tweeted. “You are not a horse. You are not a cow.  Seriously, y’all.  Stop it.”  And then the FDA linked to an extended statement, headlined, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”  The agency also Instagrammed  the same message. 


Yet FDA was not content with just exhortation.  It actively wanted to kibosh the careers of visible opponents. The intensity of that campaign is seen in the case of the three docs, Apter, Talley Bowden, and Marik.  Reporting on the legal proceedings, Courthouse News summarized the agency’s effort on September 1, “The FDA’s campaign caused [the three doctors] problems: A major Houston hospital system forced Talley Bowden to resign her privileges; Apter was referred to physician regulatory boards of Arizona and Washington state for discipline; Marik was forced to resign from his post at Eastern Virginia Medical School, where he was a medical professor and chief of pulmonary and critical care.”  


Okay, so that’s some heavy kiboshing.  The FDA has, in fact, operated that way for a long time.  However, in our time, the forces of opposition—the forces of freedom—are more organized, more articulate, and, thanks to the internet, more able to do its own research and to share ideas.  Also, crucially, resistors have been more able to draw upon legal resources.  So the three doctors found legal counsel from Boyden Gray PLLC, the law firm founded by the late C. Boyden Gray, a well-known figure in conservative legal circles, whom I eulogized here.  Gray served as counsel to George H.W. Bush during his eight years as vice president, 1981 to 1989, and his four years as president, 1989-1993.  From that vantage point, Gray participated in all the great legal-policy events of those dozen years, including the epochal Senate confirmation fight of Supreme Court Justice Clarence Thomas.  Another positive Gray legacy, germane to any issue concerning the FDA, is the C. Boyden Gray Center for the Study of the Administrative State, a unit of the Antonin Scalia Law School at George Mason University.  Thanks to Gray and many others, the public’s understanding of the so-called “fourth branch” of government—the alphabet soup of regulatory agencies—has improved in recent years, and much of that new understanding is critical and reform-minded.  How did these agencies, including the FDA, get to be so powerful, and what can be done to make them operate within constitutional metes and bounds?  All important questions, in need of further debate and deeper understanding.   


In other words, the Gray firm was the perfect choice to represent Drs. Apter, Talley Bowden, and Marik in their fight against the FDA.  The plaintiffs had originally filed suit against the agency in June 2022, objecting to its campaign of harassment against them, but in December of last year, a U.S. District Court judge dismissed accepting FDA’s claim that it was immune from such suits.  But then, in February 2023, with help from the group America’s Frontline Doctors, Gray took on the case, seeking to reinstate the lawsuit.  And so on September 1 came the ruling from the three-judge appeals court panel, the honor roll consisting of Don R. Willett, Edith B. Clement, and Jennifer W. Elrod.  In deciding that the doctors’ suit could continue, the judicial trio opined, “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”  


In the words of mask- and vax critic Dr. Jay Bhattacharya, “A big loss for the @US_FDA, which overstepped its authority and competence during the pandemic.” In fact, there’s more at stake here than just a single legal case, important as that case is.  Bhattacharya went further, tweeting, “Public health officials, in their ridiculous and anti-scientific messaging & policies about the covid vaccine, all but guaranteed that a substantial portion of the public would lose trust in public health officials and in vaccines more generally.”  That’s the real import; people no longer trust Big Health to make decisions for them.  To put it another way, the fundamentals of official medical expertise and public trust are out of alignment, and that means, in a democracy, that there will have to be a realignment.  That is, a new political settlement based on this changed understanding of governmental legitimacy. 


We can see this larger and more profound potential in those words of the appeals court, FDA is not a physician. There’s a heckuva thought there, the idea that the FDA does not know more about treating you than does your doctor—or maybe you yourself.  It might seem obvious that doctors and patients know more about localized facts than some distant bureaucracy.  Indeed, in this era of personalized medicine, aided by big data and all the other advanced techniques, it’s all the more obvious that FDA is an inferior source of knowledge, especially about an individual’s unique medical situation.  And yet the law—including the sneaky accretion of law that is the essence of the administrative state—says otherwise.  According to the current regime, the FDA knows better, for all 335 million of us, and it must be obeyed.  


Yet of course, many disagree, and those disagreers are now organized, to wit, the Apter-Talley Bowden-Marik lawsuit, which has been closely covered by many journalists, including Emily Miller, who has written about this case with passion, as well as professionalism.  “This case has broad implications for protecting the practice of medicine from unlawful interference by the FDA,” said Jared Kelson, a lawyer with Gray, speaking after the judges’ ruling.  “It’s about ensuring that federal agencies act only within their statutory authority. The FDA crossed a bright line here.”  


A New Order for the Age


We’ll have to see how this particular legal case unfolds, but this much we know already: A big chunk of the public mistrusts the FDA/CDC/NIH establishment.  For instance, a poll from last year found that just 44 percent of Americans trust what the CDC has been saying about Covid.  To be sure, polls can be all over the place, depending on how the questions are worded and the reliability of the pollster.  Wisely, the country is not governed by polls, but rather, by the Constitution.  And the Constitution allows for plenty of freedom and diversity, both for individuals and states.  Fully exercising that freedom, Americans across the 50nstates have widely diverse opinions on, for instance, former NIH official Dr. Anthony Fauci; some admire him, others revile him.  That’s freedom for you.


The Constitution should, indeed, be a bulwark against the one-size-fits-all bulldozer of the federal government’s administrative state.  At the same time, the Constitution should provide protection for heterodox opinion, including on medical matters.  Here we can learn from Supreme Court Justice Oliver Wendell Holmes, Jr. who wrote famously in 1929, “If there is any principle of the Constitution that more imperatively calls for attachment than any other it is the principle of free thought—not free thought for those who agree with us but freedom for the thought that we hate.”  That’s the sometimes uncomfortable essence of free speech: If it’s really free, it includes the speech we hate


So now, why shouldn’t the same principle apply to medicine?  Why shouldn’t doctors be free to prescribe what they think best for their patients?  Why shouldn’t patients themselves be free to choose what they see to be the best path?  And if someone else thinks that path is abhorrent, well, here’s where that Holmes quote comes in.  Just as with free speech, free medicine might well include things we hate


To be sure, the larger society has rights, too.  And there are tried-and-true methods for protecting public health and the community, based on common law, as well as, of course, the Constitution.  But as to the individual and his or her doctor, there are privileges and immunities that should always be protected.  And if, in fact, they haven’t been protected in recent years and decades, then they need to be restored.  


That’s what could be happening in Texas now.  And if the fate of the court case is uncertain, the Texas state government could step in, enacting a law to protect the liberty of doctors and patients.  There’s no reason why Texas should bow down to the diktat of the FDA or any other dubiously constitutional element of the administrative state.  


And of course, states other than Texas could stand up for themselves.  Plenty of other states could seize the moment to instantiate the principle: FDA is not a physician. The result would be profound, albeit not completely new.  As Thomas Jefferson said, We don’t need new ideas, we simply must rediscover the American mind.  


In such a rediscovery, we would see the proper reassertion of federalism, the self-determination of the states within the federal union.  Some states, perhaps many, would choose to keep the FDA in charge of their medical and entrepreneurial destinies, exactly as today.  To borrow a phrase, If you like your FDA you can keep it.  Same with CDC, and its rules.  This country is, after all, diverse, and so the rights of blue states, as well as red states, should be protected.  If Blue prefers the status quo, so be it.  However, Blue shouldn’t be able to impose on Red, and vice versa. 


As for the forces of medical freedom—which is also personal health freedom, and entrepreneurial freedom—they don’t need to win everywhere. They just need to win somewhere.   Perhaps in Texas, perhaps in some other state, or states.  And if so, then the next grand experiment in federalism—the states as laboratories of democracy--will commence.   


Such experimentation could and should extend far beyond Covid.  Patients and doctors working to combat every malady know about the wet blanket—more often, the dead hand—of the FDA.  And so they all, too, would benefit from a new era of freedom. 



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