Bill would allow off-label drugs to treat COVID-19
Sen. Doug Mastriano, a contender to be the Republican Party’s nominee for governor, has introduced legislation to make it easier for state residents to obtain combinations of hydroxychloroquine and azithromycin as well as ivermectin.
Senate Bill 1089 was introduced in the Senate last week and referred to the Health and Human Services Committee, which is chaired by Sen. Michele Brooks, R-Crawford/Erie/Mercer/Warren. Similar legislation has been introduced in the House of Representatives (HB 1741) by Rep. Dawn Keefer, R-York/Cumberland.
Mastriano, R-Adams/Cumberland/Franklin/York, cites studies showing the drugs’ effectiveness: a peer-reviewed study published in the International Journal of Antimicrobial Agents found that an early treatment drug combination (hydroxychloroquine and azithromycin) decreased hospitalizations by 84% and resulted in a five-fold reduction in death while another peer reviewed study conducted by physicians in Brazil between July 2020 and December 2020 examined over 150,000 participants in the city of Itajai and found that those who took Ivermectin, compared to those who did not, had a 56% reduction in hospitalization and a 68% reduction in death.
“Despite a record of success, it is increasingly difficult for a patient in Pennsylvania to obtain these early treatment drugs following prescription from a provider,” Mastriano wrote in his legislative memorandum. “I’ve heard from many constituents who are encountering pharmacies that refuse to dispense these drugs even with a valid prescription note from a doctor. A combination of politics, bureaucracy, and profit margin motivations is driving pressure on doctors and pharmacists to reject the use of proven off-label drugs.”
While Mastriano cites studies supporting the bill, the jury is still out on the drugs’ effectiveness. A study published in February 2021 in The Lancet showed neither hydroxychloroquine nor hydroxychloroquine and azithromycin combination shortened the clinical course of outpatients with COVID-19, and hydroxychloroquine alone had only a modest effect on SARS-CoV-2 viral shedding. There are several such studies available in dozens of medical journals.
In January, the Food and Drug Administration posted on its website that there are risks associated with hydroxychloroquine and chloroquine, including abnormal heart rhythms such as QT interval prolongation and ventricular tachycardia. These risks may increase when these medicines are combined with other medicines known to prolong the QT interval, including azithromycin. Hydroxychlroquine is authorized for emergency use in hospitalized patients when clinical trials are not available.
“We are warning the public that hydroxychloroquine and chloroquine, either alone or combined with azithromycin, when used for COVID-19 should be limited to clinical trial settings or for treating certain hospitalized patients under the EUA,” the FDA post states. “The EUA was based upon limited evidence that the medicines may provide benefit, and for this reason, we authorized their use only in hospitalized patients under careful heart monitoring. If a healthcare professional is considering use of hydroxychloroquine or chloroquine to treat or prevent COVID-19, FDA recommends checking www.clinicaltrials.gov for a suitable clinical trial and consider enrolling the patient.”
The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea. Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.
“My legislation will allow physicians and pharmacists to prescribe and dispense drugs already approved by the FDA for off-label use in the treatment or prevention of COVID, without penalty from licensing boards,” Mastriano wrote. “My bill will also clarify that a pharmacy may not decline to fill a prescription of a COVID early treatment drug based solely on their opinion of the drug.”