Their Lips are Moving Again

Trump claims he’s going off-label again

While denying he was using it but saying he’d be willing to, Vice President Mike Pence committed some other lies today about hydroxychloroquine sulfate, the drug Trump claims he is taking to prevent COVID-19.

Asked during the Fox interview if he had concerns about the message Trump’s use of the drug sends, Pence noted that the FDA approved the off-label use of the drug so physicians could prescribe it if they deemed it appropriate.

Yeah, no.

First of all, the Food and Drug Administration doesn’t “approve” drugs for off-label use. That’s an oxymoron. Here’s the FDA’s own explainer on the subject:

When you are prescribed a drug for its approved use, you can be sure:

    That FDA has conducted a careful evaluation of its benefits and risks for that use.

    The decision to use the drug is supported by strong scientific data.

    There is approved drug labeling for healthcare providers on how to use the drug safely and effectively for that use…

If you and your healthcare provider decide to use an approved drug for an unapproved use to treat your disease or medical condition, remember that FDA has not determined that the drug is safe and effective for the unapproved use.

Keep reading.

The FDA did put out an Emergency Use Authorization for hydroxychloroquine on April 27. That was the Monday after Trump led into the weekend by suggesting an off-label use for Lysol and bleach. The EUA says this:

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of hydroxychloroquine sulfate supplied from the Strategic National Stockpile to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible…The suggested dose…is 800 milligrams of hydroxychloroquine sulfate on the first day of treatment and then 400 milligrams daily for four to seven days of total treatment based on clinical evaluation.

First, Trump himself added mass quantities of hydroxychloroquine to the national stockpile and the FDA is requiring that this supply and only this supply be used.

Second, Trump is not hospitalized and does not have a positive COVID-19 diagnosis, so he fails the FDA’s basic criteria.

Third, Trump claims he began taking hydroxychloroquine 10 days ago. The FDA says it’s only advising it be used four to seven days. And again, that’s for hospitalized patients who have been diagnosed with COVID-19.

There is no universe in which Pence and Trump’s claims that he is taking the drug in any kind of approved manner could be true.

But truth has nothing to do with the Trump strategy. Stealing headlines, which his claim of taking this drug (have we mentioned we don’t for one minute believe it?), was his more likely goal.

The same day the FDA dates its emergency use authorization for hydroxychloroquine, Trump held a press conference rolling out his plans to make COVID-19 testing universally available. The headlines three weeks later were not about his administration’s failure in that area, and so many others related to the pandemic. Instead, they were about Trump’s unsubstantiated claim that he is evading the virus by taking a drug from which sales he most likely stands to profit.

We must ignore Trump’s claims and keep our eyes on the real truth. There’s only one version of that.


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