U.S. Sits on Millions of Pills That Treat Lupus, Not Covid

(Bloomberg) -- The Trump administration continues to stockpile 63 million doses of hydroxychloroquine to use against Covid-19 despite it not being seen as an effective treatment. Meanwhile, some patients with lupus, which the drug is proven to work against, can’t fully fill their prescriptions.

Federal trade adviser Peter Navarro criticized the results of large clinical trials debunking hydroxychloroquine’s effectiveness for Covid-19 during an interview Wednesday with CNN. He said he would continue to stockpile millions of doses of the drug that’s been aggressively promoted by President Donald Trump.

“At the end of the day if I’m right,” Navarro said, “thousands of Americans are dying because the media and the FDA have made hydroxychloroquine out to be dangerous.”

Large clinical trials have shown hydroxychloroquine to be ineffective against the virus and the U.S. Food and Drug Administration in mid-June rescinded its clearance allowing for emergency use of the drug. The administration is pushing the FDA to reissue the authorization based on a clinical trial from Henry Ford Health System in Detroit that has been criticized by the research community for not being randomized.

“If the Detroit study is accurate, and I think it is, we could be saving 500 lives a day potentially. It’s tragic,” Navarro told Bloomberg News.

Autoimmune Disease

At the same time, hydroxychloroquine is FDA-approved to treat lupus as well as rheumatoid arthritis.

Lupus is a chronic autoimmune disease that can cause pain and inflammation across the body, attacking skin, joints and internal organs like kidneys and the heart. The Lupus Foundation of America estimates about 1.5 million Americans suffer from the disease.

In a survey of patients between March and May, the group found that 55% of patients had trouble filling their prescriptions, according to a statement last month. As of June, that number fell to 33% who had issues gaining access to their medication.

Trump’s support of the drug as a “game changer” against Covid-19 spurred runs on the pills starting early on in the pandemic. Lupus patients have felt the pinch, in some cases dangerously so, though supply is improving now that most doctors and hospitals aren’t offering hydroxychloroquine as a Covid-19 treatment.

“The inability to access the medication and take it as directed can result in worsened symptoms and flares – and even require immediate medical attention,” Karen Costenbader, chair of the Lupus Foundation’s medical-scientific advisory council, said in the foundation’s statement.

The FDA’s backtracking on hydroxychloroquine prompted talks between the government and pharmaceutical companies that had given pills to the stockpile about what could be done with leftover tablets.

Novartis Donation

Novartis AG’s Sandoz unit, for instance, donated 30 million tablets. Last month, Novartis said it was considering what to do with anything that might be returned, noting it would not use any of it for commercial use.

But amid Navarro and Trump’s insistence that hydroxychloroquine will work, those talks about what to do with the stockpile have not yet resulted in the release of any of the pills.

Novartis on Wednesday said it expects supply to be returned from the government, but the company is still in discussions on the time line and the amount, said Jamie Bennett, a spokeswoman for Novartis.

Stephanie Bialek, a spokeswoman for the Department of Health and Human Services, said more than a month ago the government was in talks with drugmakers about options and expected to have guidance any day for states and hospitals that had received hydroxychloroquine from the stockpile.

Bialek said Wednesday that HHS was still in contact with drugmakers but that the pills remained in the stockpile.

©2020 Bloomberg L.P.