Florida hoarding unproven COVID-19 treatment
Melanie Payne
Fort Myers News-Press
As lupus patients struggle to find supplies of a drug they desperately need, the state of Florida has hoarded a stockpile for a COVID-19 treatment shown not to work.
In April, Gov. Ron DeSantis arranged for a donation of 1 million doses of hydroxychloroquine for hospitals around the state. Less than 2% was distributed, leaving 983,900 doses sitting in Tallahassee.
"We had 1,000 people send letters asking the governor to address what was becoming a shortage," said Amy Yalden, chief executive officer of the Lupus Foundation of America Florida Chapter. She said they heard nothing: "No response. No. Never."
As the drug remains warehoused, people with lupus, who rely on hydroxychloroquine to stave off organ damage, pain and disability, are paying triple the cost and often having to substitute the more expansive brand-name version, Plaquenil.
"People can't get their normal prescription, and we don't know where the drug is that went to the hospitals," Yalden said last month.
What Yalden didn't know was that most of the doses never made it to the state's medical centers.
"To date, 16,100 doses have been distributed to six hospitals that requested the medication," according to an email Thursday from the state's Joint Information Center on COVID-19. "The state still has 983,900 doses on hand."
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According to the manufacturer Amneal, hydroxychloroquine has a shelf-life of 24 months.
The rise and fall of HCQ
Near the start of the coronavirus pandemic, anecdotal reports of success of using hydroxychloroquine to treat COVID-19 infections spread through social media networks and news reports. The drug, commonly called HCQ, has been used for decades to prevent malaria and is a standard treatment for lupus and rheumatoid arthritis, another autoimmune disease.
The real boost for HCQ came in March when President Donald Trump began promoting the drug, writing in a March 21 tweet that in combination with an antibiotic it could be "one of the biggest game changers in the history of medicine." On May 18, Trump said he had started taking HCQ to prevent contracting a COVID-19 infection.
A few weeks later, on June 3, the results of a controlled study were published in the New England Journal of Medicine showing that HCQ was no better than a placebo in preventing a coronavirus infection.
Medical experts had cautioned against relying on anecdotal evidence rather than clinical trials to prove the drug's efficacy. But DeSantis didn't wait for scientific proof that the drug worked.
On April 7, DeSantis announced he had reached out to Trump, requesting he speak with India's prime minister to pave the way for a "second shipment" of HCQ from Teva Pharmaceutical Industries to Florida hospitals. In the same news conference, DeSantis said New Jersey-based Amneal Pharmaceuticals would be shipping "one million doses" to Tallahassee the next day.
Lupus patients left out
The state's hydroxychloroquine debacle rankles Sara Esidore of Tampa. The 37-year-old has been battling lupus for 17 years.
"Taking it from one sick population and giving it to another does not seem like a solution, and it's very frustrating for our community," Esidore said. "This is a tried-and-true drug for lupus approved in 1955, and it was not approved for COVID when this happened."
Hydroxychloroquine keeps debilitating flare-ups of the disease under control, Esidore said. "I had all my organ failure when I was off of it. I didn't have any organ failure when I was on it."
Prescribers bear the brunt of the responsibility for the shortage, said Nick Monfreda, a board member and treasurer of the Florida chapter of the Lupus Foundation.
"I got frustrated with physicians who wrote the prescriptions. There's no reason a dentist should be writing a prescription for hydroxychloroquine," said Monfreda, of Boynton Beach. "If you are a responsible physician, you shouldn't be writing these prescriptions. I blame the physicians more than the media and politicians."
In Florida, various medical professionals, including physician assistants, advanced registered nurse practitioners, optometrists, podiatrists and dentists can write prescriptions.
Monfreda, who has lupus, said the day after hearing about hydroxychloroquine being used for COVID-19, he went to his regular drugstore to have a prescription refilled. While there he casually asked if they had heard about the hydroxychloroquine and COVID-19 connection. "Yeah, we're already out," was the answer, he said. And he couldn't get his prescription refilled.
First-time prescriptions for HCQ in the last two weeks of March increased 1,235% nationwide when compared to the first two weeks of March, according to IPM.ai, a subsidiary of the Cambridge, Mass.-based Swoop, a company specializing in health care data and analytics. In Florida, prescriptions for HCQ increased 2,973% during March 16-31 compared to March 1-15.
Esidore said for the past few months people with lupus have struggled to find hydroxychloroquine. The foundation set up supplies through an online pharmacy, but that system has increased the cost of HCQ for patients.
"Previous to all this it was a very affordable drug, $30 to $40 for a three-month supply," she said. And even though the foundation has worked to get a lower-cost online supplier, people are still paying three times as much for 30 days, and most can't get more than a two-week supply.
Addressing the shortage
Of the estimated 1.5 million Americans with lupus, 90% are women. The disease disproportionately affects people of African, Asian, Native American and Pacific Islands descent.
People who have been on the drug for years can't get their prescriptions filled for more than a couple of weeks. And they can't access the cheaper generic version. The brand name version, Plaquenil, can cost 10 times as much.
"It makes a big difference whether I take it or not," Rachelle Stephenson, 38, of Lakeland, told The Ledger in April, "and the longer I go without it, the worse all of that gets, to the point I can't get out of bed because it's too painful. And I also get too weak, where I just have no energy, where I feel like I just want to sleep 24 hours a day. And my rash will come back."
The Lupus Foundation also asked the state's Pharmacy Board to discuss the drug's shortage and the devastating physical and financial effects it was having on people with chronic autoimmune disorders such as lupus.
"They wouldn't even put it on the agenda," Monfreda said.
"The Florida Board of Pharmacy has not discussed hydroxychloroquine or any other drugs related to COVID-19," the board's communications office wrote in response to an inquiry from USA TODAY Network-Florida.
Most other states addressed the inappropriate prescribing and hoarding of hydroxychloroquine to "ensure that patients with chronic disease can continue to manage their diseases and that the most critically ill get the medication they need," according to data compiled by the National Alliance of State Pharmacy Associations.
The response in all but 12 states ranged from advising pharmacists to use their "professional judgment" when filling prescriptions to prohibiting pharmacists from filling prescriptions if it was for use in prevention or treatment of COVID-19.
Some state health departments advised physicians that there were no peer-reviewed studies of the efficacy of the drug as a treatment for COVID-19 and warned that "inappropriately prescribing or dispensing medications constitutes unprofessional conduct. … Prescribers and pharmacists are obligated to follow the law, standard of care, and professional codes of ethics in serving their patients and public health."
Yalden, of the Florida Lupus Foundation, said a doctor contacted her after reading about the plight of people with lupus unable to get the drug. He had prescribed it for himself and family members. He told her he hadn't realized the impact of his actions and those of other physicians.
Similar acknowledgment and contrition have been lacking from regulatory and elected officials. People with lupus were "completely ignored. We didn't get any help from our leaders," Esidore said.
"Now that we know this could happen ... I wish there were better planning and protocols put in place," Esidore said. "If this happens with another drug and another disease, I'd like to see supplies preserved for the patients that need it for their chronic illness."