Must We Choose Between Free Speech and Patient Safety?

What do Kim Kardashian, the First Amendment and patient safety have in common?

A few weeks ago, Kardashian promoted a drug called Diclegis on her Facebook, Instagram and Twitter accounts, which, according to the Los Angeles Times, have more than 100 million followers. Kardashian is pregnant, and her post was about the drug’s effectiveness against the nausea and vomiting some pregnant women experience.

Kardashian’s post linked to the safety information page of the drug’s website, but the FDA wasn’t happy – it ordered the drug’s manufacturer, Duchesnay, to take down Kardashian’s remarks, for which the company paid, from its social media presence because the feds said they didn’t cover enough drug facts. That violates the agency’s requirements that prescription drug promotions include information about risk and specific use. That’s why all those TV commercials include announcers speed-reading all the drug’s possible side effects.

“These violations, wrote the FDA’s Robert Dean in a letter publicly released, “are concerning from a public health perspective because they suggest that Diclegis is safer than has been demonstrated.”

The letter said any promotion of the medicine also must indicate that it has not been studied in women with a severe vomiting condition.

Kardashian’s representatives said that she had offered only her personal experience, that Duchesnay had signed off on it and that questions should be directed at the company. Still, she was a paid company representative, right?

A week later, a federal court ruling that had nothing to do with Kardashian’s morning sickness or her compensated advice about how to handle it nevertheless might relate. It might help to grease a slippery slope of patient harm. The court said that First Amendment free speech protection allows drug companies to market off-label uses of their medications provided that the information they provide is accurate and not misleading.

Off-label, as we’ve explained, refers to the use of a drug to treat a condition or patient population for something other than what the FDA approved it for. Doctors may prescribe drugs off-label, but drug companies and their representatives may not promote them for these purposes.

The court was talking about Vascepa, a prescription omega-3 fatty acid aimed at patients with severely elevated triglyceride levels. Its manufacturer, Amarin, promoted it for patients whose levels were less extreme, meaning its consumer market would be hugely enlarged if doctors prescribed it for them as well.

One study had determined that the drug helped treat people with lower triglyceride levels. But the FDA declined to approve it for them until the company provided evidence that such therapy actually would reduce the risk of heart attacks for that population.

As explained by MedPageToday.com, the judge ruled that the FDA can’t restrict Amarin’s First Amendment right to disseminate off-label information about Vascepa as long as the company didn’t say anything false or misleading.

The ruling affirmed and expanded a ruling from 2012 known as Caronia, which first broadened the right of free speech for pharmaceutical company reps. The Amarin judge said that the Caronia right applied “across the board to all truthful and nonmisleading promotional speech.” This “speech” means the statements drug reps make to doctors when they promote off-label uses.

Amarin’s case hinged largely on its desire to give “scientific” papers to doctors that seemed to support Vascepa for the off-label population and the prevention of coronary disease. As MedPageToday noted, the judge accepted without question that they were “peer-reviewed … scientific publications.”

Even the FDA said Amarin was within its rights to distribute the papers. But that doesn’t mean they were compelling science. According to MedPageToday, “It has long been clear that ‘scientific publications,’ even when ostensibly ‘peer-reviewed,’ do not always meet the highest, or even minimal, scientific standards.”

Is it cynical to look askance at the fact that three of the five authors of one paper were Amarin employees? That a commercial company was paid for editorial assistance? That some authors were funded by Amarin?

As a recent editorial in the Los Angeles Times pointed out, off-label use can be beneficial for patients whose doctors have investigated such applications and can make informed decisions. “But the FDA takes a dim view of pharmaceutical companies using that information to market their products without the agency’s specific approval, and for good reason,” the paper opined. “The companies and their sales staff have a strong financial incentive to expand the possible uses of each drug, whether or not it’s particularly helpful. Off-label uses can also have as-yet-undiscovered risks.”

What’s “accurate” and “not misleading” can be interpreted too liberally when the profit motive comes into play. Millions of dollars in settlements have resulted from Big Pharma twisting the facts into commercial convenience, and lots of patients have been harmed by their actions, which they consider simply the cost of doing business, as the judgments often cost less than the money made by off-label use.

The L.A. Times made clear that if the FDA’s authority to regulate how pharmaceutical companies market their drugs to doctors is compromised, “its ability to protect the public will be severely diminished,” and that the Amarin ruling “makes this scenario possible, and it will take a concerted effort by the FDA to continue setting limits on eager pharmaceutical salespeople.”

These restrictions aren’t about people who are famous for being famous blabbing to the people who want to know what they think, even when their thoughts come from the wallet and not the heart. But anyone, a private party, a company, its representatives, must take responsibility for promoting products that might help some people but that have such enormous potential to hurt so many others.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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