Lupus patients struggle to get drugs after Trump touts drug in fight against coronaviruses – News – Daytona Beach News-Journal Online

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Patients with autoimmune diseases, such as lupus and rheumatoid arthritis, are having trouble finding their drugs after President Donald Trump noted that the drugs were potentially useful in the treatment of coronavirus.

Hydroxychloroquine keeps Dana McCool working.

The Deltona resident takes the drug twice a day to treat her lupus and scleroderma, diseases which, if left untreated, can have devastating effects on a person’s organs and joints.

McCool is generally able to quickly get to his pharmacy in Orange City to get the life-saving drug, but the past few weeks have been troubling since President Donald Trump cited this specific drug as a potential treatment for COVID-19 , suddenly. making the drug, critical for those with autoimmune diseases, difficult to find.

“It was totally irresponsible of him to do it,” said McCool of the president’s remarks. “It’s like they created a river without thinking of the liferafts. “

The president praised the potential of hydroxychloroquine sulfate and chloroquine phosphate, both of which can be used to treat and prevent malaria, in the treatment of coronavirus.

But doctors and career scientists, including Dr. Anthony Fauci, the federal government’s leading expert on infectious diseases, were not as quick to get along.

Fauci said in a press briefing in March that much of what is known about antimalarials in the treatment of COVID-19 is anecdotal and not based on controlled clinical trials.

[CORONAVIRUS: Get the latest news and updates on the pandemic]

Although the drugs are not approved by the United States Food and Drug Administration for the treatment of COVID-19, the FDA issued an Emergency Use Authorization on March 28.

“Based on in vitro clinical and anecdotal evidence limited in case series, chloroquine phosphate and hydroxychloroquine sulfate are currently recommended for the treatment of COVID-19 inpatients in several countries,” wrote Denise Hinton, FDA chief scientist, in a letter to Dr. Rick Bright, assistant assistant secretary for preparedness and response and director of the Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services.

[READ: Letter from the FDA issuing Emergency Use Authorization of drugs to treat coronavirus]

Such a limited amount of research “would at best be considered hypothetical,” wrote doctors Jinoos Yazdany and Alfred HJ Kim in an article titled “Use of hydroxychloroquine and chloroquine during the COVID-19 pandemic: what every clinician should know ”that was published in the Annals of Internal Medicine.

Yazdany is the head of the rheumatology division at Zuckerberg San Francisco General Hospital and Kim is an assistant professor in the rheumatology division at the Washington University School of Medicine in St. Louis.

“The hasty and inappropriate interpretation of the literature by public leaders can do harm,” the doctors wrote. “In this time of crisis, it is our ethical duty, as physicians and researchers, to organize and direct patients to rapid and well-executed randomized trials which can clarify whether, when and for whom antimalarial drugs are useful in COVID-19. “

With at least 10 trials in progress, the demand for chloroquine phosphate and hydroxychloroquine sulfate has increased. As a result, there is a shortage of drugs, according to the FDA database.

Hoarding also contributed to the decrease in availability.

Michael Jackson, executive vice president and CEO of the Florida Pharmacy Non-Profit Association, expressed this concern in a letter to Governor Ron DeSantis on March 27.

“Our members report that almost all of the new prescriptions for hydroxychloroquine are issued to prescribers themselves or to family members of prescribers,” Jackson wrote.

He also said that the drug was used prophylactically for patients who could contract the virus.

Jackson also asked DeSantis “to issue an emergency order, or to order the Pharmacy Council in collaboration with the Council of Medicine to issue an emergency rule, limiting these practices. “

At a press conference on March 28, DeSantis said that if chloroquine works to treat coronavirus, he wants to make sure it is available.

” I am not a doctor. I don’t tell anyone to take it or not take it, ”said DeSantis. “But I believe in the idea of ​​a right to try. If someone is really in bad shape and there is no other treatment available and the doctor thinks it is something that could be useful, then we want that patient to have access to it. “

Hospitals have requested the drug, according to the governor’s office, and the state will send inbound supplies to facilities in Orange, Broward, Hillsborough and Miami-Dade counties.

However, independent pharmacies are particularly struggling to get a decent supply of medicines if they can get one.

J. Roger Accardi, owner and pharmacist at Accardi Clinical Pharmacy in Orange City, where McCool is sponsoring, said his pharmacy had received about 100 phone calls in the two days following Trump’s comments.

“You have, relatively, two large groups of people with different reasons but with the same desire to get the drug,” Accardi said in a telephone interview.

In the past two weeks, Accardi has only been able to provide McCool with a seven-day supply of hydroxychloroquine sulfate at a time. Accardi was able to find a 30-day supply last week, but McCool will have to visit pharmacies in Winter Park and Kissimmee, about an hour’s drive from Deltona, to obtain it.

“They literally saved my life,” said the 55-year-old Deltona resident about Accardi and his team.

The stress of not knowing if she will be able to get the medication she needs has triggered lupus flares for McCool, who has two adult children and four grandchildren.

“What happens is that the body begins to attack healthy cells,” said McCool. “You can have heart problems, you can have kidney problems, you can have lung problems. “

McCool, who lives with her husband and four dogs, said the breakouts made breathing difficult and caused joint flu, so getting up and out of bed takes about 30 minutes.

As CEO of McCool Transportation Management, Inc., a freight company, McCool was able to work from home.

Following the governor’s direction to keep the house, McCool closed Feral Note Studios, a rehearsal and recording studio that she opened in Holly Hill, to the public and sent cleaning supplies to those who finished projects while following a social distancing and sanitation recommendations.

Just like McCool’s pharmacist, Accardi, Joseph Corgan, owner and chief pharmacist of the Palm Coast Home Care Pharmacy, said he had trouble getting medication for patients with autoimmune diseases. Lately, it has only been able to provide patients who need the drug with a 30-day supply when it is generally able to give them a value of 90 days.

“We haven’t been able to get any in the past few weeks,” Corgan said in a telephone interview. “We check every day to see if he is available. “

For those who suffer from autoimmune diseases and those who treat them, this is of great concern.

“There aren’t many options for some of these rare diseases,” said Corgan.

A joint letter to Vice President Mike Pence of the Lupus Foundation of America, the American College of Rheumatology, the American Academy of Dermatology and the Arthritis Foundation echoed these anxieties.

[READ: Joint letter to Vice President Mike Pence from Lupus Foundation of America, American College of Rheumatology, American Academy of Dermatology and Arthritis Foundation]

“For lupus patients, hydroxychloroquine is the only drug that improves survival,” the letter said. “Many of our patients are unable to fill their prescriptions due to significant shortages of hydroxychloroquine, with reports validated across the country from pharmacies that have run out of supplies and half of the drug manufacturers reporting backorders . “

Concerns about chloroquine phosphate and hydroxychloroquine sulfate don’t stop at the supply.

“There is a concern that people are essentially trying to go out and find chloroquine in some form that is not in the prescribed medication,” said Sean Beckmann, assistant professor of biology at Stetson University. “They don’t get the same thing and they potentially introduce things into their bodies that could kill them. “

This is what happened in Arizona when a man ingested chloroquine phosphate, an additive often used to clean aquariums, according to a press release from Banner Health, a nonprofit health care system with acute care facilities in Arizona and five other states.

“Most patients who become infected with COVID-19 will only need symptomatic care and self-isolation to prevent the risk of infecting others,” the statement said. “The routine use of specific treatments, including drugs described as” anti-COVID-19 “, is not recommended for out-patients, including chloroquine, an antimalarial. “

Following approval from the FDA for emergency use, the United States Department of Health and Human Services “accepted 30 million doses of hydroxychloroquine sulfate given by Sandoz, the generics and biosimilars division of Novartis , and 1 million doses of chloroquine phosphate donated by Bayer Pharmaceuticals, for possible use in the treatment of patients hospitalized with COVID-19 or for use in clinical trials, “according to a press release on the department’s website. .

The ministry also indicated that additional donations are possible “and that companies have increased production to provide additional supplies of drugs to the commercial market”, which “will ensure that these drugs will also remain available to patients who depend on them for treatment of malaria, lupus and rheumatoid arthritis.

While some states and pharmacies have taken steps to preserve the supply of these drugs for the aforementioned patients, Florida has failed to do so.

Accardi hopes that attention to hydroxychloroquine sulfate and chloroquine phosphate will actually translate into an increase in supply that will provide sufficient care for patients with autoimmune diseases and trials for the treatment of COVID -19.

“Now everyone is watching the drug and everyone involved with the drug, including the manufacturers and everyone along the distribution chain,” said Accardi.

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