Column: FDA shoots itself in the foot by settling a groundless lawsuit over its ivermectin warnings

“You are not a horse,” read a tweet posted by the Food and Drug Administration on Aug. 21, 2021.

A fairly unexceptionable observation, one would think. But there was more to the tweet than a zoological judgment.

The FDA’s goal was to advise individuals against taking ivermectin, a medication used to treat parasitic infections in livestock, to treat COVID-19. “Stop it with the #ivermectin,” the agency advised on Instagram. “It’s not authorized for treating #COVID.”

It was those latter two lines that exercised three physicians who had been prescribing ivermectin for patients. They sued the FDA in 2022, asserting that its advisory illegally interfered with the practice of medicine — specifically with their ability to continue prescribing the drug.

A federal judge in Texas threw out their case, but the 5th Circuit Court of Appeals — the source of a series of chuckleheaded antigovernment rulings in recent years — reinstated it last year, returning it to the original judge for reconsideration.

Now the FDA has settled the case by agreeing to delete the horse post and two similar posts from its accounts on the social media platforms X, LinkedIn and Facebook. The agency also agreed to retire a consumer advisory titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”

In defending its decision, the FDA said it “has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”

That sounds reasonable enough, but it’s a major blunder. It leaves on the books the 5th Circuit’s adverse ruling, in which a panel of three judges found that the FDA’s advisory crossed the line from informing consumers, which they said is all right, to recommending that consumers take some action, which they said is not all right. (The panel comprised one judge appointed by Donald Trump, and two appointed by George W. Bush.)

Business

Column: Right-wing judges are on a mission to stop the FDA from warning consumers about snake oil

Right-wing hacks on the 5th circuit federal appeals court, emboldening medical charlatans, questioned the FDA’s advice not to take ivermectin for COVID-19.

Sept. 27, 2023

That’s a misinterpretation of the law and the FDA’s actions, according to Dorit Rubinstein Reiss of UC College of the Law in San Francisco. “The FDA will seek to make recommendations against the misuse of products in the future, and having that decision on the books will be used to litigate against it,” she observed after the settlement.

The FDA’s settlement is just the latest in a series of misjudgments and reversals that have eroded the authority it used to wield as a guardian of public health.

As I wrote last year, undermining the FDA long has been a right-wing project. That’s because the agency’s duty is to stand in the way of anyone desiring to push unsafe and ineffective drugs and devices at unwary consumers for profit, and also to stand in the way of a perverse idea that personal freedom includes the freedom to be gulled by charlatans.

At this very moment, the Supreme Court is weighing a challenge to the FDA’s 20-year-old endorsement of the safety of the abortion medication mifepristone — a case that has zero to do with science and everything to do with the partisan assault on abortion rights. The court will hear oral arguments in the case Tuesday.

Unfortunately, the FDA has sometimes given ammunition to its critics. In 2021, the agency gave hasty approval to the purported Alzheimer’s drug Aduhelm, despite professional judgments that it was ineffective and overly expensive. Doctors and insurers shunned the drug.

In January, its distributor, Biogen, abandoned the drug to pursue other possible treatments. Biogen said its decision had nothing to do with costs and efficacy concerns but, really: If it worked, there’s no way it would be put on the shelf.

As for the ivermectin issue, it’s by no means ancient history. Despite its having been conclusively shown to be useless against COVID-19, some doctors are still pushing it irresponsibly on patients.

The nuances of the agency’s assertion that ivermectin is no longer worth litigating will be lost on unwary consumers misled by an announcement from the plaintiff’s camp, “The FDA loses its war on ivermectin,” and that the case was about “FDA overreach into the doctor-patient relationship.”

Business

Column: How the FDA’s lousy judgment and a greedy drug company combined to hit Medicare members hard

The FDA approved an unproven Alzheimer’s drug, and its manufacturer priced it in the stratosphere. Result: Medicare members get higher premiums.

Nov. 15, 2021

Neither is true, despite the claims in tweets posted by Mary Talley Bowden, one of the doctors who brought the case. Bowden’s tweet was endorsed by Robert F. Kennedy Jr., one of the leading sources of healthcare disinformation at large today.

Let’s take a look at the background of this lawsuit, and why the FDA’s settlement can be so injurious to public health.

Ivermectin became the COVID nostrum of choice for anti-vaccine activists in 2021, after their previous darling, the antimalarial drug hydroxychloroquine, fell out of favor. As was the case with hydroxichloroquine, scientifically valid studies showed that ivermectin was useless either for prevention or treatment of the disease.

That conclusion was reinforced as recently as last month, with the publication of a paper by a team from Oxford University that found that the drug is “unlikely to provide clinically meaningful improvement in recovery, hospital admissions, or longer-term outcomes” for COVID. The authors further stated that “further trials of ivermectin for SARS-Cov-2 infection ... appear unwarranted.”

Nevertheless, prescriptions for ivermectin soared from about 3,600 per week before the pandemic was declared to 88,000 per week in mid-August 2021. Some consumers were even taking the veterinary formulation of ivermectin, which was commonly used for deworming horses and which produced a surge of calls to poison control centers in Mississippi, prompting the FDA’s warning tweets.

By placing their faith in ivermectin instead of treatments known to be effective against COVID, unwary consumers were only harming themselves. A survey by Boston University and the University of Michigan estimated that Medicare and private insurers had wasted $130 million on ivermectin prescriptions for COVID in 2021 alone.

The FDA’s campaign against the drug may have borne fruit. The “You are not a horse” tweet racked up 24 million views in its first two days, making it what the FDA said was the most popular tweet in its history.

That also prompted the lawsuit from the three doctors, who asserted that the FDA’s campaign had interfered with their medical practices and brought them disciplinary difficulties.

Ivermectin prescriptions shot up from about 3,600 per week before the pandemic to 88,000 in mid-August 2021, after anti-vaccine promoters talked it up as a COVID treatment. But it’s useless against the disease.

(Centers for Disease Control and Prevention)

Plaintiff Robert L. Apter said the FDA’s position had caused pharmacists to refuse to honor his ivermectin prescriptions for patients and led to disciplinary proceedings against his medical licenses in Washington state and Arizona. Bowden said she had been forced to resign her privileges at Houston Methodist Hospital and had been “consistently and publicly ridiculed ... for prescribing ivermectin to treat COVID-19.”

The third plaintiff, Paul Marik, said he had been forced to resign a professorship at Eastern Virginia Medical School and as director of the intensive care unit at Senara Norfolk General Hospital in Virginia. Following the FDA’s social media campaign, he said, the medical school had ordered him to “not speak publicly about ivermectin.”

The plaintiffs’ assertion that the FDA had interfered with their medical practices deserves some scrutiny. The Washington medical regulators’ May 16, 2023, complaint against Apter, for instance, doesn’t rest merely on the fact that he had prescribed ivermectin, but accuses him of doing so in 14 specific cases without adequately examining patients before prescribing.

Instead, his prescriptions were based “solely on an online questionnaire and online chat,” according to the complaint, which is still pending. Apter did not respond to a request for comment sent to a telemedicine service with which he has been associated.

In several cases in which the patient was a woman of childbearing age, the complaint states, Apter failed to determine that the patient was not pregnant — crucial information because ivermectin is “contraindicated during pregnancy.”

In some cases, the complaint states, he failed to inform patients of alternative treatments for COVID, including vaccination.

More generally, the lawsuit overlooks the fact that the FDA has no power to discipline doctors for prescribing a medication that the agency has licensed, even when the prescription is for “off-label” use — that is, a purpose for which it has not specifically been approved. That’s the case with ivermectin, which the FDA has approved as a treatment for parasitic diseases, but not for COVID. COVID is not caused by parasites.

Nor does the FDA have any authority to order or even prevent consumers from taking an unapproved drug or a licensed drug for an unapproved use. All it has is the power of publicity. Its authority generally extends to advising the healthcare community and consumers of the scientific finding underlying the use of approved drugs — and keeping off the market preparations that have not been shown to be safe and effective.

Business

Column: After the FDA delayed enforcement against stem cell clinics, unlicensed operators poured in

The FDA gave stem cell clinics three years to comply with its rules. The number of illegal clinics exploded.

Nov. 4, 2021

The appellate judges described the agency’s advisories about invermectin as a COVID treatment as more than “factual statements and information.” The online posts, the judges said, “contain syntax that is imperative rather than declaratory (for example ... ‘Stop it with the #ivermectin’).” The title of its consumer advisory, the judges observed, is “Why You Should Not Use Ivermectin” for COVID. (Emphasis in the judges’ ruling.)

But their position is dangerous for public health, Reiss says, and runs counter to the FDA’s traditional role. Legal scholar Leon Liu observed nearly 30 years ago that the FDA is “one of the few federal agencies in government which is specifically required and authorized by law to use publicity.”

The 1938 law that established the FDA’s authority explicitly gave it the right to disseminate “information regarding food, drugs, devices, tobacco products, or cosmetics in situations involving ... imminent danger to health or gross deception of the consumer.” If there was ever a case where “gross deception of the consumer” was involved, it’s the hawking of a drug to treat COVID that is known to be worthless for that purpose.

The law also empowers the agency to engage in “collecting, reporting, and illustrating the results” of its investigations.

If the 5th Circuit’s decision is allowed to stand, the FDA’s role as bulwark against snake oil will be grievously undermined. Consumer advice, including advice couched as strong admonitions, has long been part of its responsibilities.

The agency’s protective role has often been questioned by purveyors of useless but lucrative nostrums, such as the stem cell treatments peddled by unlicensed clinics claiming to treat everything from multiple sclerosis to Alzheimer’s to erectile dysfunction, for none of which stem cell treatments have been scientifically validated.

At this moment, the FDA website on stem cell clinics advises consumers: “Don’t believe the hype .... Some unscrupulous providers offer stem cell products that are both unapproved and unproven. So beware of potentially dangerous procedures.”

Stem cell hucksters would undoubtedly prefer for that cautionary language to be removed. The 5th Circuit’s ruling might give them a leg to stand on. That won’t be good for anybody. The FDA should have pursued the ivermectin case instead of settling. That would have shown that it’s still devoted to its consumer protection purpose.