The FDA Gets Tough Questions About Hydroxychloroquine From Republican Senators
BY STACEY LENNOX
PJ Media
(AP Photo/Andrew Harnik, File)
The debate over hydroxychloroquine has faded from the forefront as big tech has worked to suppress information and silence the voices of doctors and researchers promoting it. However, it appears the controversy over the drug has encouraged some senators to take a closer look, and it seems they are asking the FDA the right questions.
Senators Ron Johnson (R-Wis.), Ted Cruz (R-Texas), and Mike Lee (R-Utah) sent a letter to FDA Commissioner Stephen Hahn explicitly asking about the agency’s handling of information regarding the drug and its use during the pandemic. Doctors and researchers advocating for hydroxychloroquine are recommending it be used in high-risk outpatients.
In the letter to Hahn, the senators are asking about specific actions the agency has taken regarding hydroxychloroquine. The current FDA guidance is that it should not be used outside the hospital setting for COVID-19, and the Emergency Use Authorization (EUA) has been withdrawn. Given the safety profile of the medication and the fact it is used daily on an outpatient basis around the world for malaria prevention, malaria treatment, rheumatoid arthritis, and lupus, this guidance is ridiculous on its face.
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Finally, these senators are standing up for that relationship and demanding clarity from the FDA. From the letter:
However, we have heard from licensed physicians that have had a far different experience with the FDA’s approach. The physicians are concerned about the FDA’s decision to revoke the March 28th EUA for HCQ and CQ for treatment of COVID-19. They have described the clear differences between inpatient and outpatient treatments and how this decision has affected their ability to treat patients in different settings. The physicians have warned that the FDA’s EUA revocation of HCQ and CQ has led to misinformation and confusion across the country. Some states have restricted the ability of physicians to write and pharmacies to fill HCQ and CQ prescriptions under longstanding and well-established authority to prescribe FDA approved drugs off-label with a patient’s informed consent and according to their clinical judgement.
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To better understand the FDA’s actions, the letter requests four specific pieces of information:
- Studies or data that definitively shows prescribing hydroxychloroquine or chloroquine within seven days of COVID-19 symptoms is ineffective or harmful.
- Produce studies or data on the use of hydroxychloroquine or chloroquine for COVID-19 in outpatient settings under a doctor’s care, including as a preventative. They specifically exclude late-stage studies involving hospitalized patients.
- Provide any public statements issued by the FDA to clarify the agency does not regulate the practice of medicine and explaining state governments may not regulate or prohibit the sale of the drugs.
- Information on potential treatments for COVID-19 that have been used internationally and whether the FDA has approved those for use in the United States. If not, the senators want to know what steps are being taken to ensure they are.
These requests are a kick in the derriere to the bureaucracy. It is unconscionable for the FDA not to clarify their role in the practice of medicine and even worse for them to remain silent in the face of other entities trying to interfere with it. While it does not appear they have ever made a statement like the one the senators are requesting, hopefully, one will be forthcoming.
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It would be even more concerning if the agency withdrew the EUA based on the debunked Lancet study and has done nothing to correct their position. In an extensive search, I can find no studies indicating that short-term outpatient use of hydroxychloroquine at approved dosages is dangerous or deadly. It will be surprising if the FDA has one.
Dr. Harvey Risch, an epidemiologist from Yale, has done a review of these studies and arrived at the conclusion that treatment with hydroxychloroquine is effective for high-risk outpatients. Dr. Risch told Mark Levin on “Life, Liberty, and Levin” Sunday that it was some of the most convincing data he has seen in his career:
Clearly, President Trump has not given up on the potential this drug combination may hold. Dr. Risch’s assessment is clear. For high-risk patients over 65 or with pre-existing conditions, the outpatient use of the hydroxychloroquine, zinc, and azithromycin combination has shown a significant reduction in hospitalizations and death rates.
He asserts that we have let politics overrule science, and it is costing thousands of lives. Hopefully, senators pressuring the FDA will cause significant movement and clarity. The FDA owes its response by the end of business tomorrow. If the misinformation can be effectively cleared up, it will be a game-changer. The senators must continue to press the FDA and restore the doctor-patient relationship.