A Spokane center has kept busy in recent weeks with questions about potential drugs for patients hospitalized because of COVID-19.
Meanwhile, a coronavirus vaccine isn’t likely to be a reality before the end of this year, said Danial Baker, a pharmacotherapy professor who runs the Washington State University Drug Information Center at the College of Pharmacy and Pharmaceutical Sciences. The center offers a service to pharmacists, doctors and health care workers statewide who request information about the use of various drugs and potential side effects.
Previous questions to the center have included ones regarding the drug hydroxychloroquine for COVID-19 patients. The U.S. Food & Drug Administration on Monday revoked its emergency use authorization for oral formulations of hydroxychloroquine and the related drug chloroquine while citing that, based on evidence, it was no longer reasonable to believe they might be effective in treating COVID-19. Remdesivir, an antiviral drug, is still part of emergency investigations for COVID-19 treatments.
“When we went into the initial shutdown phase and everyone went remote, we encouraged people to email the center rather than call, so the volume dropped off,” said Baker, who works with a pharmacy resident and four-year pharmacy students to answer questions. “That volume has started actually to increase, and we’re continuing to get some of the inquiries on other drugs that we used to get.
“The number of questions lately on COVID have decreased, but a lot of them before really centered in on the hydroxychloroquine initially. A few of the inquiries also were relative to some comments made previously about ibuprofen and ACE inhibitors that have gone away.”
Baker said pharmaceutical companies’ press releases about drugs in development for potential treatments can cause some confusion for practice sites and within the health care system. Such information often goes out on social media, far ahead of scientific studies and data, he said.
The hydroxychloroquine and ibuprofen questions were examples of that, he added, “where the depth of science in published literature is relatively deficient given the hype that some of it has gotten through various vehicles.”
As for hydroxychloroquine, he said the quality of early studies weren’t ideal, with some rush to publication without full peer review or in-depth evaluations. Another dilemma was that this drug is commercially available and used in the treatment of rheumatoid arthritis and lupus.
“What happened is you saw the interest by health care and the public go up dramatically about potential treatment that was perceived to have some value, but since that time, a number of the studies that have been published, the press releases about the studies or preliminary information have not been so favorable,” he said.
“Unfortunately in the middle of all that were these patients who needed the drugs for their lupus and arthritis who have had difficulty acquiring the drug because the supplies of the drug dropped dramatically with demand for potential use elsewhere.”
The global pandemic has had some impacts on the overall drug supply chain, Baker said. Pharmaceutical manufacturing often involves overseas production, materials or ingredients.
“Even if you manufacture part of the product in the United States, you’re dependent on other areas of the world for anything from raw ingredients to the glass vials,” Baker said.
“In the case of a pandemic or any other natural disaster, that might hit one of those source areas, then you’re going to change the supply of something. You’ll delay production all the way through.”
Production problems also can arise if plant employees can’t work or borders are closed for shipments.
“That’s caused some discussion at the governmental level or political level of whether or not we should be bringing a lot of our pharmaceutical manufacturing back entirely in the United States, and that’s part of the discussion around COVID and the pandemic. It’s probably never going to happen.
“But the other part that’s at risk here is that if you have a disruption in the system, you can’t necessarily go to another manufacturing plant and immediately gear it up for the production of whatever you need because that new drug that needs to be produced may require equipment you don’t have; it may require skill sets of individuals who are not currently employed at that facility. It’s kind of a domino effect.”
Remdesivir’s manufacturing process requires several months in production, so there’s a potential risk of future supply shortages if demand rises, he said.
“This is a drug that has been granted emergency use because of the pandemic. It’s being restricted to hospitals’ use, but it was initially taking, according to company information, nine to 12 months to produce the drug. They changed some things, but it’s still probably taking eight to 10 months.”
“This is a drug that wasn’t fully up to speed for manufacturing.”
However, Baker said the emergency status gets the drug to people seriously impacted by COVID-19, and information on safety and impact is gathered.
“But we may not be getting an answer to how does that compare to something else,” Baker added.
One published study indicates remdesivir treatment for five days wasn’t much different than its use for 10 days. Another study considered impacts on recovery as well as on death rates.
With the same standard of care, one group got a placebo and one got the antiviral. It found a statistical difference that with remdesivir, it provided a faster recovery by about four days. However, there wasn’t statistically a difference regarding COVID-19 death rates, Baker said.
With global attention on a potential coronavirus vaccine, he said if one were identified soon, further development would require time, including ramping up manufacturing and distribution.
He said additional questions include whether enough people will take the vaccine, and if it’s manufactured in another country, would leaders allow it to be exported before dealing with its own population first?
Baker believes a vaccine that’s available likely won’t happen before 2020 ends. However, he said much research is being directed that way. The focus includes an estimated 328 drugs in development or being researched for COVID-19 and about 100 vaccines being studied.
For answering questions at the WSU drug information center, he said the emphasis is on whether science supports that certain drugs work and are safe, including new COVID-19 therapies.
“Then there is that whole drug supply chain and how all the factors come into play even if we have a drug that works. We may have an issue with the new drug let alone existing drugs and maintaining a supply that’s reasonable.”