Will the “Peasants” Revolt Against the FDA?
As you can tell, I love talking about health law issues, if you have any health law questions or better yet, need to refer a case, just drop me an email and I will answer it.
“Its a wonderful life.” In a 1946 Frank Capra Christmas movie, an angel must earn his wings by helping Jimmy Stewart’s character realize his life has value, after rich and greedy business interests have bankrupted him and ruined his life, when all he wanted to do was help people.
The movie ended happily, “every time a bell rings, an angel gets his wings.” This jingle has a very dark history, which is why I bring it up in reference to weight loss drugs like Ozempic and Mounjaro.
Martin Luther & The Efficacy of Indulgences. In 1517, a Catholic monk and professor of theology named Martin Luther, nailed his Ninety-Five Theses, or Disputation on the Power and Efficacy of Indulgences to the door of a cathedral in Wittenberg, Germany. What had disturbed Martin Luther, was the Church’s corrupt practice of selling “indulgences” to the faithful.
The church collectors claimed that the souls of loved ones needed to be “purged” of sins, before they would be permitted to enter heaven (hence the word, “Purgatory”):
“As soon as a coin in the coffer rings, the soul from purgatory springs.”
This angered Martin Luther, who knew something the peasants didn’t. The Bible, written in Latin (which Germans didn’t speak, as Voltaire observed in 1756, “the Holy Roman Empire was neither holy, Roman, nor an empire”), contained no mention of a “Purgatory.” A secret the Church kept by prohibiting the Bible from being published in a language Germans understood.
Luther’s 95 Theses were not the first challenge to the Church, but were aided by the invention of the printing press. When the peasants found out they had been defrauded, they revolted and things got ugly. (See, The Protestant Reformation, Henry the Eighth, The Spanish Inquisition, Northern Ireland, etc.).
How the FDA similarly works to keep the public in the dark, isn’t a secret, but will require explanation. I will use two of my own case files, which were a lot of fun.
Tilton vs. Richardson, 6 F.3d 683 (10th Cir. 1993.) The Rev. Robert Tilton was a Dallas televangelist who used sent out little squares of material he called “prayer cloths.” He claimed these magical bullshit cloths were the secret to God’s healing the sick. If the faithful rubbed the cloth on a sick loved one, sent in a donation along with a prayer request, then Tilton would touch the cloth and pray. God just might intervene with a miracle, for a price.
I got involved as a defense lawyer when several plaintiff’s lawyers sued Tilton for fraud, after NBC news ran a story showing that the prayer cloths were thrown in the trash after the money was removed at a bank. Tilton never touched them. He then sued my clients in a precursor to an Anti-SLAPP suit (Tilton claimed the Plaintiff’s lawyers were conspiring under 42 USC §1985 to infringe on Tilton’s 1st Amendment rights).
The 10th Circuit ruled that §1985, known as the “Ku Klux Klan Act,” was not meant to protect white preachers and threw out Tilton’s case. However, in the original case, the Texas Supreme Court in Tilton v. Marshall, 925 S.W.2d 672 (Tex.1996), ruled that the Plaintiffs could not sue Tilton for damages, because the faithful could not prove the element of “causation” (that God would have answered their prayers, had Tilton actually prayed as promised.)
State v. Valerie Saxion, Inc., 450 S.W.3rd 602 (Tex.App—Ft. Worth 2014). Although Robert Tilton’s “magical bullshit prayer cloths” might arguably have been considered a “medical device” requiring FDA approval, it wasn’t until Valerie Saxion started selling healing vitamins, that the FDA and The Texas Attorney General got involved.
Valerie Saxion was a bubbly television host on the world’s largest Christian Television network, TBN’s Alternative Health program. She began telling listeners that Selenium, which is a mineral next to Sulphur on the Periodic Table, helps prevent prostate cancer and that’s why God made it. She just happened to sell a line of vitamins containing Selenium. (She had also never heard of the FDA.)
The Consumer Protection Division of the Texas Attorney General’s office sued to silence her under the FD&C Act. There is another old saying:
When the law is against you, pound the facts.
When the facts are against you, pound the law.
When both are against you, pound the table.
Which is what I did when I argued Valerie Saxion’s case before the 2nd Court of Appeals in Fort Worth. There was no question she violated the FD&C Act. So, I countersued Gov. Greg Abbott, who was the AG at the time, for a declaratory judgment that the State of Texas can’t censor Valerie Saxion’s teaching about God’s plan when he created Selenium. (We lost.)
The FDA. Unlike Robert Tilton’s “magical bullshit cloths,” Valerie Saxion sold something the FDA did regulate. Her vitamins became “drugs” the minute she mentioned the word “cancer.” The FDA regulates drugs, for safety and “efficacy” (meaning “effective,” the word used by Martin Luther’s 95 Theses about “indulgences” 1512). Sellers of vitamins can sell Selenium with a label “Supports Prostate Health,” but will be put out of business if the seller mentions any disease, like “cancer.”
The uninitiated might think the FDA only exists to protect the public. It would be too simplistic to say they don’t care at all. However, like the Church in 1512, the FDA cares about saving people for a price.
The FDA is funded by taxpayers but is influenced, if not corrupted, by fees paid by big pharma, under a system the public doesn’t understand. When big pharma plays by FDA rules, it receives a governmental monopoly in exchange for paying the $1 billion price tag to get a drug through the patent and FDA approval process. In turn the FDA becomes the attack dog for its paymasters.
Weight loss drugs. One exception, which happened recently with weight loss drugs, occurs when the FDA approved manufacturer can’t keep up with demand. Because the manufacturer can’t lose profits on drugs it can’t make, the FDA allows generic copies to be compounded, as long as a drug is listed on the FDA drug shortage list.
What this also means is that there can be an unlimited, inexpensive supply of an FDA approved life-saving weight loss drug, that no one is allowed to sell. At least not inexpensively. This is true, even though the public suffers:
“Every time big pharma’s coffers ring, another soul from weight-loss purgatory springs.”
South Park did a masterful job lampooning this absurd state of FDA affairs in “The End of Obesity,” where Eric Cartman explained why he couldn’t get a prescription for Ozempic, “Rich people get Ozempic, and poor people get a prescription for listening to ‘Lizzo’ body positivity records.”
Martin Merritt, J.D., Ole Miss Law ’86. Martin tried over 500 healthcare law cases to jury verdict, judgment or ALJ administrative law decision. He has been selected to the 2024 D Magazine “Best Lawyers in Dallas” List, Texas Monthly’s “Texas Super Lawyers” and U.S. News and World Reports “Best Lawyers in America,” is Past President of the Texas Health Lawyers Association, Past Chair of the Dallas Bar Health Law Section and State Bar of Texas award-winning author, has published books from the ABA, and published hundreds of articles on matters related to health law and legal ethics in the Federal Lawyer, the Texas Bar Journal and many trade publications. If you have a question or need to make a referral, Martin can be contacted at his office in Dallas, Texas. Email at Martin@MartinMerritt.com