Tagged Pharmaceuticals

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‘You Pray That You Got The Drug.’ Ailing Couple Gambles On Trial For COVID-19 Cure

Josie and George Taylor stand on the porch of their home in Everett, Washington, on March 24. They are two of the first people in the U.S. to recover from novel coronavirus infections after joining a clinical trial for the antiviral drug remdesivir.(Dan DeLong for KHN)

For 10 days last month, they lay in side-by-side isolation units in a Seattle-area hospital, tethered to oxygen and struggling to breathe as the coronavirus ravaged their lungs.

After nearly 52 years of marriage, that was the hardest thing: being apart in this moment, too weak to care for each other, each alone with their anxiety and anguish.

“I worried about my husband a lot,” recalled Josie Taylor, 74, who fell ill a few days before George, 76. “Yes, I was concerned about me, but I was more concerned about what was going to happen to him.”

Despite their personal uncertainty, when a doctor approached the Taylors at their bedsides to ask if they would consent to join a study of an experimental drug to help experts learn to treat the devastating infection, each agreed.

“My answer was absolutely yes,” Josie said. “My feeling was anything I can do to help. Even if you’re stuck in an isolation room, this is affecting so many people and we have to do everything we can.”

In late March, the Taylors were discharged from EvergreenHealth medical center, heading home a few days apart. They returned to their tidy white house in Everett, tired, worn — and wondering if the clinical trial they had joined is the reason they survived the deadly disease.

The couple are among the first patients in the U.S. to recover from COVID-19 after agreeing to participate in a National Institutes of Health randomized controlled trial of remdesivir, an antiviral drug made by Gilead Sciences that once aimed to treat another infectious disease, Ebola.

The study is part of a surge in efforts to beat back the virus that as of Sunday evening had sickened more than 337,000 people in the U.S. and led to more than 9,600 known deaths.

“You pray that you got the drug,” said Josie. “The fact that we both recovered so quickly? You hope that’s the reason why.”

But neither the Taylors nor Dr. Diego Lopez de Castilla, the 41-year-old physician heading the trial at the Kirkland, Washington, hospital, know now whether the couple received injections of remdesivir — or an identical-looking placebo.

Nor do they know whether the investigational drug, designed to stop the virus from replicating, is effective at halting the disease. There are a half-dozen studies in progress across the globe testing remdesivir as a COVID-19 treatment.

At the same time, more than two dozen Phase 3 clinical trials are recruiting participants to study interventions to prevent or treat COVID-19. They range from a tuberculosis vaccine being tested on health care workers to a cancer drug that could prevent the deadly fluid buildup occurring in the lungs of COVID-19 patients.

Other drugs, including those used to treat rheumatoid arthritis and even gout are being tested to see if they reduce the body’s inflammatory response to the infection. A few studies aim to confirm whether treatments touted by President Donald Trump, the antimalarial drugs chloroquine and hydroxychloroquine, are indeed effective against COVID-19.

If any of the trials show overwhelming evidence of benefit or harm, they could be called off, with the drug in question accelerated to general use or halted.

So far, no drug appears to be a certain treatment for COVID-19. Early results regarding remdesivir are expected in late April. Officials with the World Health Organization and many media accounts have suggested the treatment could hold promise. But it’s too soon to say, said Lopez de Castilla.

“I don’t think we have enough data to be commenting,” Lopez de Castilla said. “I think it’s very premature. We’re still enrolling patients in the trial.”

Lopez de Castilla is steering clear of the political turmoil that has surrounded remdesivir and Gilead. The firm in March sought and received federal Food and Drug Administration approval for so-called orphan drug designation, but then asked the agency to rescind the designation after critics accused company officials of unfairly seeking a lucrative monopoly for the drug.

Orphan drug designation gives a manufacturer seven years of market exclusivity, a period that essentially bars competition. Consumer advocates criticized the designation because orphan drug status is aimed at products that target rare diseases, those that affect 200,000 people or fewer. Gilead received the status when U.S. cases were still hovering near 40,000 but were expected to rise far higher.

In the past two weeks, Gilead officials announced that, because of “overwhelming demand,” the company would no longer provide the drug on an individual compassionate-use basis to patients not enrolled in clinical trials and was shifting to a broader-access program.

For now, Lopez de Castilla is focused on the science, working to follow strict protocols set by the National Institute of Allergy and Infectious Diseases study expected to enroll 440 patients across 75 sites.

The double-blind trial calls for participants to receive the active drug or placebo for 10 days, and then to evaluate how they do based on a scale that moves from fully recovered to death. The drugs are given free to hospitals and trial patients. In a public letter March 28, Gilead chief executive Daniel O’Day pledged that the company would work to “ensure affordability and access.”

Since Feb. 21, 40 U.S. sites have joined the Adaptive COVID-19 Treatment Trial, with Lopez de Castilla’s team enrolling among the most patients so far: at least 20 as of April 1.

“We are a community hospital,” he said. “Although we don’t have all the resources that bigger hospitals have, we do have amazing people here.”

Still, it hasn’t been easy. For weeks, EvergreenHealth was at the epicenter of the U.S. outbreak, treating dozens of patients from the Life Care Center nursing home in Kirkland, where nearly 40 patients have died. Overall, the hospital has treated nearly 300 COVID-19 patients since Feb. 28.

The patients enrolled in the trial are among the sickest, Lopez de Castilla said. They’re those who are moderately to critically ill, including some who are unconscious and on ventilators. Obtaining consent to participate in a clinical trial from patients or families grappling with an emergency has been “very challenging,” he said.

“One of the challenges is how to enroll a patient who is already intubated,” he said. “We do this through a family member, someone who can make medical decisions for the patient.”

It can take hours to explain the procedure, describe the side effects — which could include gastrointestinal problems or elevated liver enzymes — and provide detailed information so the patient or their legal representative can make an informed decision.

Patients must understand that they could receive an unproven therapy, he said. And they need to know that, because the trial calls for half of the patients to receive the drug and half to receive a placebo, there’s a 50% chance they won’t actually receive the active drug.

One barrier has been that the trial paperwork is available only in English, which is not the first language of some patients. EvergreenHealth is working with the NIH to create at least one translation in Spanish.

Overall, about half of the patients Lopez de Castilla approached have said no.

The Taylors both fell ill in early March and ended up in a Seattle-area hospital with COVID-19, before deciding to join a clinical trial for an experimental drug. For Josie Taylor, a former second-grade teacher who volunteers for social causes, the decision was easy. “It does have to be studied,” she says. “It can’t be a knee-jerk reaction of ‘Take any medication, without knowing what the results will be.’”(Dan DeLong for KHN)

For Josie Taylor, a former second-grade teacher who volunteers for social causes, the decision to join the trial was easy. “It does have to be studied,” she said. “It can’t be a knee-jerk reaction of ‘Take any medication, without knowing what the results will be.’”

She and her husband, a retired banker, fell ill in early March, just weeks after moving from their home of 40 years to a new community 30 miles north of Seattle. Josie got sick first.

“I went to the grocery store and came out, loaded the stuff in the car and realized I was very short of breath — weirdly so,” she recalled.

She ran a fever that night, called her doctor and went to the emergency room the next morning, where she was quickly placed in isolation.

George Taylor is a Vietnam War veteran who was affected by the defoliant Agent Orange used in that war. He has multiple health problems, including prostate cancer, heart disease and Parkinson’s disease. Within a couple of days, he also fell ill.

George was sent to the ER and then to an isolation room — next to his wife’s. For more than a week, they were both seriously ill, on oxygen, uncertain about the future. “It was 10 or 11 days,” Josie said, adding wryly: “Honestly, you lose track when you’re having fun.”

Contracting the novel coronavirus has been scary. But they were heartened by the support of family, friends, even people they barely knew. “I came home to a brand-new place with brand-new neighbors and our yard had been mowed and edged,” Josie said.

Now that they’re both home, the Taylors are gradually getting back to normal. Josie still speaks slowly, pausing to catch her breath between words. She said she hopes her experience underscores the seriousness of the crisis.

“I’m hoping and praying that this drug helps a lot of people,” she said. “It’s not an old person’s issue. It’s an every person’s issue.”

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Why Hoarding Of Hydroxychloroquine Needs To Stop

A family of old antimalarial drugs — including one that some patients rely on to treat their lupus or rheumatoid arthritis — is becoming harder to get in the United States, pharmacists say, partly because of remarks President Donald Trump has made, highlighting the drugs as a potential treatment for COVID-19.

“I feel good about it. That’s all it is, just a feeling,” Trump said during a White House briefing Thursday about hydroxychloroquine. “You’re going to see soon enough.” He again trumpeted his interest in the approach at a press conference Monday.

But health officials have been quick to warn that enthusiasm for such a treatment is premature. Big clinical studies of the drug against COVID-19 are only just beginning, the head of the Food and Drug Administration has said; another study was set to begin in New York on Tuesday. And there are some good reasons to think cell studies that look promising in the lab won’t pan out in real patients, other infectious-disease experts say.

Nonetheless, with all the buzz, American pharmacists are concerned about the hoarding of hydroxychloroquine by people who don’t have an immediate need.

Dentists And Doctors Writing Prescriptions For Themselves

“Our members are definitely seeing more demand for this medication and possibly some people trying to hoard the medication,” said Todd Brown, executive director of the Massachusetts Independent Pharmacists Association.

According to Brown, it appears the hoarders include doctors and dentists who are writing prescriptions for themselves or family members.

“Pharmacists are seeing an increase in requests and prescriptions for them in instances where it’s not clear why the patient needs it at this time,” he said.

Brown suggests that pharmacists restrict prescription quantities and fill prescriptions only for patients with an active need for hydroxychloroquine.

In a statement, CVS Health said the company is “monitoring the global pharmaceutical manufacturing environment and working with our suppliers to ensure we can continue filling prescriptions for our pharmacy patients and plan members.”

CVS said it has an adequate supply of hydroxychloroquine and is taking steps to make sure the supply remains stable. Some data show hospitals stocking up on the drug as well.

State Pharmacy Boards Put The Brakes On Prescriptions

The National Association of Boards of Pharmacy said six states, so far, have taken steps to limit inappropriate prescriptions for hydroxychloroquine and preserve supplies for patients who take the medicine as approved. Those states are Idaho, Louisiana, Nevada, North Carolina, Ohio and Texas.

“Based on reports we see from the states, pharmacists have a fairly good idea that what they’re seeing is prescribers prescribing for themselves and their families and stockpiling these medications rather than prescribing for patients,” said Carmen Catizone, executive director of the NABP.

If doctors are hoarding, some colleagues say, that’s unethical. Dr. Michael Barnett, a primary care physician and an assistant professor at the Harvard T.H. Chan School of Public Health, said that even if clinical studies now in progress show the drug to be effective against COVID-19, it must be saved for those most in need.

“There are front-line physicians where, if this medication is actually effective or can be used to prevent coronavirus, they certainly could merit treatment with that,” Barnett said. And, he noted, “we are very far from knowing whether it’s effective in that manner. ”

Still, Barnett said he can see why a doctor or nurse might say, “Hey, I can’t get the masks or goggles or gowns I need to protect myself. Why not try this medication?”

Need A Stable Supply For Non-COVID-19 Patients

Though sympathetic, Barnett pointed out that this powerful medicine has serious side effects, so it should not be taken unless there’s a known benefit.

“Having sort of a free-for-all in terms of prescribing for oneself and just deciding that ‘I’m going to grab some while I can’ is the kind of mentality that can really undermine our efforts to actually have a concerted public health campaign against this disease,” he said.

More immediately, patients with lupus and rheumatoid arthritis take hydroxychloroquine daily to reduce swelling and rashes. Dr. Jeff Sparks said his patients at Brigham and Women’s Hospital were already fretting about having enough medicine on hand if stores close or it’s hard for them to go out. And then the president began calling the drug a game changer.

“The entire last week seemed to be filled with a lot of anxiety about what to do about medications and, in particular, patients asking for refills for hydroxychloroquine,” Sparks said.

Some patients are already being told they can’t get the medication or can get only a limited supply. The Lupus Foundation has asked congressional leaders to ensure supplies for lupus patients.

Sparks said hydroxychloroquine is what keeps many of his patients stable.

“So even if patients are doing well, stopping the medication could cause them to flare, which means that they then need to go on other immunosuppressants … or even get admitted and potentially get exposed [to the coronavirus] in the clinical setting,” Sparks said.

He added that hydroxychloroquine, like ventilators and masks, is a medical resource the country needs to learn to manage more carefully.

This story is part of a partnership that includes WBUR, NPR and Kaiser Health News.