President Donald Trump jumped in when a reporter asked Dr. Anthony Fauci about the controversial use of hydroxychloroquine to treat coronavirus.
The National Institute of Health now recommends against treating patients with hydroxychloroquine and azithromycin, a drug combination touted by President Trump and Gov. Ron DeSantis and used in Brevard hospitals as a promising cure to treat COVID-19 patients.
In treatment guidelines updated this week, the NIH restated that there is presently no proven cure for COVID-19. While use of the drug combination is not outright forbidden, the NIH cautions clinicians to monitor patients for adverse effects and suggests it not be used except in the setting of a clinical trial.
“Except in the context of a clinical trial, the COVID-19 Treatment Guidelines Panel … recommends against the use of the following drugs for the treatment of COVID-19:
The combination of hydroxychloroquine plus azithromycin because of the potential for toxicities.
Lopinavir/ritonavir (AI) or other HIV protease inhibitors because of unfavorable pharmacodynamics and negative clinical trial data.”
Clinical trials are underway for a variety of therapies, including for hydroxychloroquine and azithromycin.
This follows the Centers for Disease Control dropping references to “anecdotal evidence” to support the use of the drug duo on April 7.
Brevard hospital groups Parrish Medical Center and Health First previously stated that the combination of hydroxychloroquine and azithromycin had been used on COVID-19 patients.
Both sidestepped answering directly on whether they continued to use the drug combo. Steward Health Care, which declined to say if they ever used the treatment, also did not answer a question about their current protocols.
More: Local doctors prescribe controversial drug duo to COVID-19 patients
“Our physicians stay up to date with all of the latest studies and guidelines. Medical evidence regarding COVID-19 is changing regularly. We trust our providers to individualize treatment for each patient—based on their specific symptoms and needs,” read a statement from Health First.
Parrish Healthcare in an emailed statement said that “clinical decisions are always made using the very latest guidelines and information available.”
“No drug therapy is ever administered to a patient regardless of condition when it is contradicted or inadvisable.”
The first evidence for the hydroxychloroquine and azithromycin therapy was a clinical trial study from France of just a few dozen patients that was published without peer-review in mid-March. It has since been excoriated by statistical reviewers for the poor quality of the data and methodology and the journal that published has issued a notice of concern over the study.
More: The coronavirus therapy President Trump is gambling on is backed by weak scientific data
More: CDC website drops guidance, anecdotal data on Trump-backed hydroxychloroquine as COVID-19 treatment
Andy Romine, president for Rockledge Regional Medical Center, a Steward Health Care Hospital, in an emailed statement said their hospital is sharing ICU data with partners in Boston, where the medical group is headquartered, allowing them to consult data “on a case by case basis.”
“This has allowed us to employ treatments and therapies that have shown the most promising results from physicians who have cared for hundreds of these patients,” he wrote.
Romine said they are pooling expertise of physicians, nurses, respiratory therapists and pharmacy staff to determine what therapies to use.
“The combination of these efforts has led us to using the most evidence-based care we can acquire at this point in utilizing therapies that have proven most effective such as early intubation, proning the patient, and even including the use of convalescent plasma in two patients to date,” he wrote.
To date, the hydroxychloroquine and azithromycin combo has become something of a political flashpoint.
A pharmacist shows a bottle of the drug hydroxychloroquine on April 6, 2020, in Oakland, California. The malaria drug is not yet officially approved for fighting the new coronavirus, and scientists say more testing is needed before it’s proven safe and effective against COVID-19. (Photo: Ben Margot/AP)
On Wednesday Dr. Rick Bright a top government scientist working on developing a coronavirus vaccine was removed from his position as director of the Biomedical Advanced Research and Development Authority because he questioned Trump pushing the drugs.
“Sidelining me in the middle of this pandemic and placing politics and cronyism ahead of science puts lives at risk and stunts national efforts to safely and effectively address this urgent public health crisis,” Bright said in a statement calling for an Inspector General’s investigation.
But a major concern has been that the apparent endorsement of the drug by the president and others led to a run on supplies, causing shortages for those who need the drugs to treat serious conditions such as Lupus.
In response, several states have enacted limits on how the drugs are prescribed, as have corporate pharmacies such as CVS.
In Brevard and and across Florida, pharmacists reported receiving calls daily to fill spurious prescriptions for the drugs from doctors writing scripts for themselves and their families.
Dr. Brandon Roland, a pharmacist at Five Points Pharmacy in Cocoa, said that while they did not have a surge in demand for COVID-19 related scripts, securing supplies for patients with lupus or fibromyalgia has come at a cost.
“Wholesalers have raised prices astronomically,” he said. For hydroxychloroquine the price went from about $85 for a bottle of 500 pills to over $500 per bottle.
“That cost is being passed on to pharmacies,” Roland said, as insurance reimbursement to the pharmacy is a fixed amount. “It sucks to say it but wholesalers saw the opportunity as the market is huge.”
For Five Points, Roland said the biggest acquisition challenge has been on drugs needed for HIV patients that are also being tried as therapies for COVID-19.
“We service a lot of HIV patients and we’ve had trouble getting antivirals. Our biggest problem is antivirals,” he said, including a class of drugs known as “protease inhibitors” which the NIH has also recommended against outside of a trial setting.
For whatever reason those HIV drugs did not see a similar spike in pricing, only a drought of supply which forced some patients to switch therapies, Roland said. “They’re not getting the same push,” he said.
For Roland, the NIH’s new guidelines are welcome news as he is hopeful it will reduce demand, making the drugs easier to source and ideally lowering prices back to normal in a few months time.
Alessandro Marazzi Sassoon is a watchdog reporter for FLORIDA TODAY. Contact him at 321-355-8144, or firstname.lastname@example.org. Twitter: @alemzs
Read or Share this story: https://www.floridatoday.com/story/news/2020/04/24/nih-recommends-against-hydroxychloroquine-azithromycin-covid-19/3006745001/