In 2009, Alfred Caronia, then a sales representative for a pharmaceutical company working in New York City and on Long Island, was convicted of federal charges for telling doctors tall tales about the drug he was selling.
Caronia worked for a company called Orphan Medical, the manufacturer and marketer of a drug called Xyrem. Xyrem is a powerful central nervous system depressant that’s approved by the FDA for use in treating narcolepsy. Narcolepsy is by definition a rare disease, so Caronia, unsatisfied with his sales figures, went around telling doctors that Xyrem was also good for treating fibromyalgia, chronic-fatigue syndrome and chronic pain—one of the most common maladies in America. (Xyrem’s active ingredient, GHB, is also notorious as a date-rape drug.)
Caronia had no idea if what he was saying was true—the FDA didn’t know if the drug was useful in treating those conditions, and he hadn’t done any independent research—but if doctors bought his story, they’d surely buy some Xyrem from him.
Today, Caronia is a free man. On appeal, he successfully argued that his “off-label” promotion of Xyrem—his wholly unsubstantiated claims—was a form of “commercial speech” protected under the First Amendment. He did not need to know if what he was saying about Xyrem was true, an appeals court ruled; he merely needed to know that it was not false.
The FDA did not take the case to the John Roberts Supreme Court—which had been ruling in favor of “free speech” in recent cases—apparently for fear that it would lose.“Free-speech advocates”—that is, drug companies suddenly free of the burden of responsibility for the claims made while selling their drugs—rejoiced.
Under President Donald Trump, the precedent set under Caronia—legal protection for statements that could be outright lies, used in the marketing of powerful drugs to Americans—is part of a perfect storm of unraveling regulations that, if left unchecked, will usher in a new era of aggressive and unsubstantiated drug-peddling that will make Caronia’s puffery around Xyrem appear quaint.
As Jerry Avorn, a professor of medicine at Harvard Medical School, wrote in the American Prospect, Trump has vowed to slash “over 75 percent” of the rules governing prescription drugs. And Trump’s nominee to head the FDA, a physician and venture capitalist named Scott Gottlieb, has criticized the agency for prioritizing patient safety over bringing “innovative” new drugs to market.
The same man who made a living making bold assertions devoid of fact about his steaks, his vodka and his “university” is creating a prime opportunity for snake-oil salesmen in America.
“Stripping the FDA of authority to regulate pharmaceutical claims for accuracy deprives the public of a basic protection… Nonetheless, that is exactly what is happening,” Avorn wrote. “If the trend continues—and under Trump it probably will—the door will open wider to unfettered pronouncements by manufacturers about the purported benefits and safety of their drugs.”
Some of the blame also rests with Barack Obama.
In December, after Trump’s shock election, then-President Obama signed into law the “21st Century Cures Act,” which speeds up the FDA drug-approval process by allowing drug companies to rely on laboratory tests rather than controlled clinical trials—in which humans are involved and in which humans’ conditions must be improved before a drug can be declared safe and efficacious.
If a drug “works” according to some laboratory data, great! You can market and sell it to humans. The first person to buy it will be the first person to see whether or not it actually does anything—good or bad—to the human body. Buyer beware, seller don’t care.
“Sales pitches by prescription drugmakers have often been glitzy and over-hyped, but until now they at least had to satisfy the FDA’s high standards for scientific accuracy,” Avorn wrote. “Now, commercial free-speech rights may be invoked to give a pass to most statements a company chooses to make, even if there is no more than a grain of ‘truthiness’ to them.”
Gottlieb has yet to be confirmed as FDA chief, and Trump has yet to follow through with his pledge to dismantle the FDA.
He also has yet to follow through with a campaign promise to reduce the high cost of prescription drugs. Rather than allow Americans to buy cheaper generic drugs from Canada or overseas, where the drugs’ safety and efficacy carries a scientific guarantee, there is a very real chance the Trump administration may push a version of Caronia’s off-brand marketing as a solution instead.
This is an example of history repeating itself.
In the 1800s, the Chinese laborers building the Transcontinental Railroad relied on a liniment to soothe muscles aching after a day’s work. The oil, heavy in omega-3 acids that we know today to reduce inflammation, was derived from the Chinese water snake. Smelling opportunity, unscrupulous (white) hucksters made great show while selling their own “patent” medicines, making extravagant claims of their unique, bona-fide formulation’s one-hundred percent certified healing power!
Outrage from fleeced consumers (as well as tainted food and drugs that outright killed people) lead to the passage of the 1906 Pure Food and Drug Act, one of the country’s very first significant consumer protection laws. At least we had us a good run.
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