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FDA Can Provide No Justification for Warnings on Hydroxychloroquine

MacKenzieOct 21, 2020, 6:29:48 AM


On Aug 18, Sen. Ron Johnson (R-Wis.), Sen. Mike Lee (R-Utah), and Sen. Ted Cruz (R-Tex.) asked the Food and Drug Administration to “provide any studies and data that informed the FDA’s apparent determination that giving HCQ [hydroxychloroquine] or CQ [chloroquine] to infected outpatients within seven days from the onset of symptoms, under a doctor’s supervision, will have no clinical effect and may be harmful to the patient.”

A reply was requested by Aug 25. One finally arrived on Oct 6.

This reply cites no studies or data demonstrating harmful effects in outpatients receiving HCQ or CQ for COVID under a doctor’s supervision.

Table 1 in the letter lists 22 studies, at least six of which were in hospitalized patients, and the majority of which showed a favorable effect.

There is a growing list of more than 130 studies summarized on the website c19study.com. Most show a favorable effect. Of studies of early treatment, 100 percent show a favorable effect, with a median improvement of 64 percent. Of late studies, 63 percent were positive, with a median improvement of 26 percent.

“The FDA’s response is evasive and fails to answer several of the Senators’ excellent questions. If the FDA responded like this a court of law, a judge would order it to answer the questions asked,” AAPS states.

The Association of American Physicians & Surgeons (AAPS) asks: “Are we to conclude by implication that the FDA’s determination of no benefit and potential harm from HCQ had no foundation?”

The FDA letter states, “There are currently no drugs or biological products approved or licensed for the treatment of COVID-19 in the United States.” It acknowledges that physicians have the legal right to prescribe approved drugs “off label” as they deem appropriate. However, FDA’s apparently unfounded assertion that HCQ has no clinical effect or may be harmful is being used to restrict use of HCQ, even in the absence of any approved therapy, AAPS notes.

FDA is vigorously contesting an AAPS lawsuit that requests a court order to release, instead of hoarding, the Strategic National Stockpile of donated HCQ to pharmacies willing to dispense it to the public, and to retract its harmful assertion.

AAPS calls for congressional oversight concerning the FDA’s statements and their effect in denying Americans access to a safe, lifesaving drug.AAPS has represented physicians of all specialties in all states since 1943. The AAPS motto is omnia pro aegroto, meaning everything for the patient.