Off-Label Libel

All the noise that various commentators have been making about President Trump’s “promoting” the medication known as hydroxychloroquine is ridiculous and the most transparent yet of the leftists’ desperate attempt to discredit this president. They have described the drug as “unproven” and speculated that Trump has a financial interest in the production and distribution of it. All of this is false innuendo and nonsense.

First of all, President Trump’s statements cannot in fairness be seen to be promotion. If anyone wants to see what real promotion of pharmaceuticals is like, they only have to watch the commercials on television. What Trump is doing is informing the public that there is a possible effective treatment that could already be available, and, in fact, is being used with measured success.

Concerning the “unproven” allegation, it is a half-truth and thus effectively false and misleading. Hydroxychloroquine has been available for over four decades. The Federal Drug Administration has responsibility for testing and approving, among other things, pharmaceuticals for public distribution here in the United States. The approval is a two-step process: the drug has to be proven first to be safe, and then if found to be safe, approved for effectiveness; that is, the drug works for the specific malady or disorder for which the manufacturer seeks approval.

Hydroxychloroquine has without equivocation, been approved to be safe. There are side effects, as there are with any pharmaceutical. The FDA looks at the nature and severity of possible side effects before approving a drug, and requires warnings to be given.

As far as effectiveness is concerned, hydroxychloroquine was tested for its effectiveness in treating malaria. It was found to be effective for that purpose. It has not been found to be effective for treatment of the Corona-19 virus infection. One reason for this is the virus was only known about for the last 3 to 4 months, and approval takes a long time, sometimes years to obtain, and the process is expensive. Furthermore, the patent for hydroxychloroquine expired some time ago, and it is unlikely a potential manufacturer would go to the considerable expense to seek approval for an off-label use.

While the FDA regulates the manufacture and sale of pharmaceuticals, as well as some foods, it does not practice medicine, or attempt to regulate medical practice. If a physician or other qualified practitioner determines that a drug may benefit the patient who has some disorder other than the one for which the drug was approved to be effective, that physician may prescribe it. This is called “off-label” use. It is common and is part of advancing medical practice and information. It has been estimated that up around one-fifth of drug prescriptions are for “off-label” use. Pharmaceutical manufacturers generally are not allowed to “promote” the sale and use of their products off-label. Upon an unsolicited inquiry by a practitioner, certain information regarding the efficacy of an off-label use can be provided by a manufacturer.

Furthermore, there is no evidence that Trump has any more of a financial interest in hydroxychloroquine use that anyone else in this country — or elsewhere.

For more information see
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3538391/

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