The following article was originally published in the Ohio Capital Journal and published on News5Cleveland.com under a content-sharing agreement.
Hydroxychloroquine sales skyrocketed in Ohio the day President Donald Trump first touted the unproven anti-malarial drug as a treatment for COVID-19.
Researchers say the drug has no curative or preventative value against the disease and can cause serious heart complications in people who take it.
Limited data provided by the Ohio Board of Pharmacy shows pharmacists went from dispensing about 6,000 pills per day in early March to 53,000 on March 19, theday President Donald Trump first extolled the drug at a press briefing.
Trump has remained supportive of the drug as his own Food and Drug Administration hasrevoked authorization for the use of hydroxychloroquine on the coronavirus, citing the potential for harm including “serious cardiac adverse events” andunlikelihood of effectively treating COVID-19.
The Ohio Board of Pharmacy, according to a spokesman, does not track hydroxychloroquine as it does controlled substances like Oxycontin or medical marijuana. The board compiled spotty data from large chain pharmacies including Walgreens, Giant Eagle, CVS, Meijer, Rite Aid, Kroger and Walmart from late February and early April.
The companies did not all provide full data for the six-week span. The data is an underestimation as it does not capture all sales in the timeline from the chains or prescriptions filled by independent pharmacists.
“I don’t think anybody keeps track of that,” said Ernest Boyd, executive director of the Ohio Pharmacists Association.
Researchers at the CDC investigated who prescribed the drug — typically used to treat malaria, lupus and rheumatoid arthritis — as its popularity surged nationwide despite thin evidence.
In areport last week, researchers wrote that new prescriptions nationwide for the drug by specialists (mainly eye doctors, anesthesiologists, and heart doctors) with no history prescribing it went from producing 1,143 prescriptions in February to 75,569 in March, an 80-fold increase from a year prior.
“Holy cow,” said Dr. Leanne Chrisman-Khawam, a MetroHealth physician who prescribes hydroxychloroquine (not for use with COVID-19) and takes it for her own autoimmune disorder, after learning of the CDC’s findings.
“This is very concerning and not how medicine is supposed to work.”
On two occasions since March, the state Board of Pharmacy tapped the brakes on pharmacists’ ability to give out the drug. Under heavy political pressure and about 1,900 voicemails and phone calls, it backed off its proposal to ban pharmacists from prescribing the drug for COVID-19.
Gov. Mike DeWine publicly urged the board to stand down before its ban took effect. He said the decision should be between doctors and their patients, and the board did not take enough public comment.
“I do not have a position in regard to the use of this particular drug for covid patients,” he said.
‘A standard of care issue’
In the hydroxychloroquine story, timing is everything.
State data shows drug sales skyrocketed after Trump’s remarks and plummeted after the Board of Pharmacy filed anemergency rule March 22 limiting pharmacists to prescribing only a 14-day supply of hydroxychloroquine and requiring patients to demonstrate a lab-confirmed COVID-19 diagnosis.
Emergency rules last 120 days, and the board did not seek to codify the temporary provision.
Cameron McNamee, a board spokesman, said members issued the rule because of a shortage for patients who regularly take hydroxychloroquine, given the demand spike for uses associated with COVID-19.
On March 28, the U.S. Food and Drug Administration issued an emergency use authorization allowing hydroxychloroquine in the national stockpile to be distributed to patients hospitalized with COVID-19.
Studies soon beganlinking the drug to fatal heart problems. On April 24, the FDA warned against the use of the drug outside clinical trials and hospitals after hearing “reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine.”
See full report for footnote. Source: CDC
By June 15, the agency revoked its authorization, finding the drug is “unlikely to be effective in treating COVID-19.” Likewise, given “ongoing serious cardiac adverse events,” the agency deemed the risks outweigh any potential benefits.
The Ohio Board of Pharmacy stepped in, filing a rule July 20 prohibiting pharmacists from filling prescriptions for hydroxychloroquine as a treatment or preventative for COVID-19.
In the 10 days between filing the rule and its July 30 effective date, the board received 1,500 emails and more than 400 voicemails, which it provided to the Ohio Capital Journal in a records request.
The emails overwhelmingly oppose the rule. They range from measured (“this is not right”), to abusive (“this is genocide”), to anti-Semitic (calling board members “jew rats”), to conspiratorial (several cite Bill Gates). Many misstate the scientific consensus that hydroxychloroquine is not an effective treatment for COVID-19.
McNamee said members ultimately decided responding to a potential drug shortage is the board’s responsibility, but controlling doctors is not. At DeWine’s behest, the board withdrew the proposal before it took effect.
“Now that it’s moved from [supply] shortages to a standard of care issue, that’s where it becomes a Medical Board issue,” he said.
The state Medical Board did not respond to inquiries.
‘You don’t just screw around with physiology’
According to Chrisman-Khawam, physicians evaluate medicine by scaling out two questions: How likely is this drug to help a patient? And how likely is it to harm a patient?
She takes hydroxychloroquine for an autoimmune disorder and she’s aware of potential side effects. They range from minor (nausea, headache) to serious and possibly fatal, like heart arrhythmia and decreased white blood cell counts.
Scientists in Brazil halted a research project on the effects of hydroxychloroquine after several patients given higher doses of the drug (already hospitalized with COVID-19) died. They detected no treatment value against the virus.
Similarly, the National Institute of Health stopped its clinical trial as well. Its results showed no harm, but found the drug was unlikely to help patients.
“A data and safety monitoring board met late Friday and determined that while there was no harm, the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19,” according to anNIH statement.
Boyd, the OPA’s executive director, said hydroxychloroquine has a “very narrow therapeutic range,” and that there’s not much difference between a good dosage and a lethal dosage.
“The amount you take to kill you is not that much above the amount it takes to cure you,” he said.
He said there are several factors that led to its surge: Trump’s endorsement drove demand for patients, who have gotten used to asking their doctors for drugs advertised on TV.
“The drug manufacturers are kind of building this thing in the people’s mind that they should go in and demand drugs from their docs, which I think is kind of goofy,” he said.
Chrisman-Khawam put some blame on doctors improperly evaluating the available research, or others looking to “do something” when there aren’t any great options.
However, she put most the blame directly on Trump using the bully-pulpit to blast out bad science.
“You don’t just screw around with physiology and say, ‘What do you got to lose?’” she said, echoing Trump’s March comments backing hydroxychloroquine.
“It’s very complicated and I say we should leave it to the doctors.”
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