During recent appearances, President Donald Trump has energetically hyped hydroxychloroquine and chloroquine as potential miracle cures for COVID-19, even though they haven't been approved for this purpose by U.S. agencies and the only evidence that they may have a positive effect is purely anecdotal. His argument can basically be summarized like so: The drugs have proven safe in other contexts, and if they don't do anything to knock down the novel coronavirus, no harm/no foul.
Colorado Representative Diana DeGette begs to differ. She's written a letter to Food and Drug Administration Commissioner Dr. Stephen Hahn over concerns that the medication will be hoarded by COVID-19 patients, making it difficult to obtain for individuals who need it to treat conditions for which it's been approved: lupus, rheumatoid arthritis and malaria.
DeGette spokesperson Danielle Cohen, corresponding via email, stresses that these concerns aren't merely theoretical.
"In the last two weeks, our office has received 165 messages from constituents about this issue," she reveals. "The majority of these messages came from lupus patients here in the district" — DeGette serves Colorado District 1, which includes most of Denver — "who have either already faced problems getting their medications or are increasingly concerned about their future ability to get them."
Cohen adds: "A key concern raised in many of these letters is the fact that, in many cases, there are no alternatives to hydroxychloroquine or chloroquine. For example, for patients with lupus, hydroxychloroquine is the only medication shown to increase survival."
In other words, patients who know the meds can help keep them alive fear they'll be snapped up by people they may not actually help.
Here is DeGette's letter:
April 8, 2020
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Dr. Hahn:
I am writing regarding concerns I have about reports of hoarding and utilizing certain medications to treat COVID-19, without adequate clinical data that point to their efficacy. Additionally, I am concerned that the publicity certain treatments are receiving are putting the populations that rely on them to survive at extreme risk.
Specifically, hydroxychloroquine (HCQ) and chloroquine (CQ) are currently used by tens of thousands of Americans to treat lupus, rheumatoid arthritis (RA), and malaria. As you know, these three conditions are the only indications for which these drugs are approved by the Food and Drug Administration (FDA). In fact, HCQ and CQ are often the only course of treatment for these patients.
On March 28, 2020, FDA issued an emergency use authorization (EUA) for both HCQ and CQ despite the limited in-vitro and “anecdotal” evidence of efficacy for the treatment of the coronavirus disease (COVID-19). The Centers for Disease Control and Prevention note “there are no currently available data from Randomized Clinical Trials (RCTs) to inform clinical guidance on the use, dosing, or duration of hydroxychloroquine for prophylaxis or treatment of [COVID-19].”
Since the above-referenced EUA was issued, patients with lupus and RA have already been reporting the inability to access their medications. Shortages continue to be reported across the country, including in my home state of Colorado, and on March 31, 2020, FDA added both HCQ and CQ on their drug shortage list. I am particularly concerned about anecdotes of hoarding practices of these drugs to have “just in case” as well as inappropriate prescribing of these experimental treatments which seem to be exacerbating the drug shortage issue.
To mitigate this fast-growing problem, a number of states have already begun imploring providers to restrict dispensing of HCQ and CQ solely for FDA-approved indications of use or as a part of a state-approved clinical trial. Until further information can be ascertained to prove the efficacy of these drugs for the treatment of COVID-19, I urge FDA to issue a Dear Health Care Provider Letter to warn providers against prescribing HCQ or CQ for non-FDA-approved indications for use. This would help alleviate the current drug shortage, ensure patients who rely on these medications can access their treatments, and address the misuse of these important therapeutics.
Lastly, the following information would be helpful:
• What immediate and proactive actions is FDA taking to ensure current supplies of HCQ and CQ are allocated for patients taking them for FDA-approved indications?
• What is FDA doing to address the current HCQ shortage?
• Are disbursed SNS supplies of HCQ and CQ able to be used to treat patients with FDA-approved indications in addition to COVID-19 patients?
• If so, is FDA coordinating with the Assistant Secretary for Preparedness and Response (ASPR) to use the SNS supplies to alleviate the drug shortage of HCQ?
While I support continued research to study HCQ, CQ, and any other drug as a potential treatment to COVID-19, it is imperative that patients with FDA-approved indications for use are able to access their medications. Their lives depend on it.
Your swift response is appreciated.
Member of Congress
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