FDA boosting production of drugs to treat COVID-19 also needed for other illnesses while ignoring uspto.gov inventor search faustman, faustmanlab.org, see also pubmed.org faustman dl, pubmed.org ristori + bcg
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In a joint letter, leaders of the Lupus Foundation of America and Arthritis Foundation called on state pharmacy boards and other "important stakeholders involved with the drug supply chain" to lift new restrictions imposed on dispensing and prescribing the medications. Credit: EPA-EFE/Shutterstock / Caroline Blumberg
The FDA has approved two drugs to treat COVID-19 in hospitalized patients under an Emergency Use Authorization, as 30 million doses of hydroxychloroquine and 1 million doses of chloroquine were donated by manufacturers to the strategic national stockpile, the U.S. Department of Health and Human Services announced.
The department said that the donations and efforts to boost production could ease shortages of the drugs that have become the subject of intense interest as potential COVID-19 treatments even as patients who have long depended on them to control their autoimmune diseases grow desperate about shortages in pharmacies and new restrictions on prescriptions.
In a joint letter, the leaders of the Lupus Foundation of America and the Arthritis Foundation called on state pharmacy boards and other “important stakeholders involved with the drug supply chain” to lift new state restrictions on dispensing and prescribing the medications, and to divert some of the medications now stockpiled or reserved for hospitals to treat COVID-19 for use by patients who depend on them.
“In many cases, patients are forced to ration their medication or go without it altogether, placing them at greater risk of worsening disease,” the group presidents, Ann M. Palmer, of the Arthritis Foundation and Stevan (cq) W. Gibson of the Lupus Foundation of America, wrote in a letter directed to state pharmacy boards.
While questioning how the donations and boosted production would be distributed, they would "certainly be a step in the right direction," the Lupus Foundation responded in a statement, “but our work is far from over."
Tens of thousands of people use the medications daily to prevent and treat flares of their autoimmune diseases which can cause extreme pain, fatigue, organ damage and early death. They now feel like their health is being sacrificed in the fight against COVID-19, said Talia Madden, a lupus patient from Island Park.
“It’s almost like we’re trading an issue for an issue,” said Madden, 32, who has used Plaquenil, the brand name for hydroxychloroquine, since she was diagnosed at age 16. “I believe this keeps me alive and the idea of not having this medicine is terrifying to so many of us.”
New York now limits their use to FDA-approved indications and to state approved clinical trials for COVID-19 patients, and limited prescriptions to a 14 day supply with no refills. People like Madden typically get prescriptions for a three month supply and forcing such patients to go out every 14 days for supplies would further expose them to infection, the Foundations said.
In addition, they sought flexibility so that doctors can continue to prescribe the medications for diseases not FDA-approved but supported by scientific literature, such as juvenile idiopathic arthritis, Sjogren’s Syndrome, sarcoidosis, Q fever, and porphyria cutanea tarda.
The efficacy and safety of use of hydroxychloroquine and chloroquine in treating COVID-19 is unproven in large-scale clinical trials. Small studies in France showed improvements with its use along with azithromycin, an antibiotic, while a small study in China did not show patients fared better with its use. While generally well tolerated, hydroxychloroquine can cause sometimes fatal heart problems with patients with underlying heart disease while chloroquine, an older antimalarial drug, can show toxicity at higher doses. New York is receiving large quantities of the drugs for use in observational clinical studies in hospitals here.
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