It’s an exciting notion: A $10, two-week course of this drug could reduce death and hospitalizations. The drug could be used to fight ongoing outbreaks in the United States and would be a particular godsend for lower-income countries that may have to wait years for vaccines against the virus. But fluvoxamine, as well as other old drugs showing potential against covid, face hurdles to full evaluations.

Drug companies have no incentive to spend millions to test new uses for cheap, off-patent drugs. Chances are slim that any drug, even one showing promise in early trials, would provide a major benefit. And early enthusiasm for covid treatments that later flopped has “made people gun-shy,” said , a professor of preventive medicine at the University of Southern California.

In particular, former President Donald Trump’s premature promotion of hydroxychloroquine likely stymied efforts to find other generic cures. The Food and Drug Administration granted emergency use of the malaria drug in March, then revoked the authorization less than three months later after evidence showed it was more likely to harm than help patients.

“We doctors who want to use evidence-based medicine feel somewhat burned by the hydroxychloroquine experience and really want to see good studies before we actually jump on the bandwagon,” said , clinical director of the division of infectious diseases at Brigham and Women’s Hospital in Boston.

And that poses a Catch-22. , the National Institutes of Health, the world’s largest public funder of biomedical research, has shown little interest in studies of repurposed drugs. Without big money, it’s hard to do the research needed to show whether existing treatments could work against covid.

As a result, efforts to repurpose drugs have fallen to philanthropists, some in the Bay Area. “We’re missing out on public health benefits of the drugs we already have because we’re relying almost entirely on capitalism and private industry to make advances,” said Elaine Lissner, founder of the San Francisco-based , which is supporting covid research on fluvoxamine and other low-cost oral drugs.

Repurposing is a long shot, yet compared to creating drugs and vaccines, the approach has clear advantages during a fast-moving pandemic. “If it works and it’s on the shelf, you don’t have any development time,” said , a specialist in infectious diseases who consults with companies, investors, government and philanthropies. One of the best treatments in the covid arsenal — the common steroid dexamethasone — is a repurposed drug. But it is recommended only for hospitalized patients who are seriously ill.

Danzig was “very excited” last April by news that a team led by University of California-San Francisco researchers had that, when used early on, could counteract infections with SARS-CoV-2, the virus that causes covid. “I’m thinking, if we can rapidly test some of these in clinical trials, we can have answers by October.”

Yet these studies . Solid covid trials of early treatments are particularly hard to pull off. Patients often must enroll within days of noticing symptoms. And without a national research infrastructure, “it’s hard to get anyone’s attention to participate in a trial or refer to it,” said , a psychiatrist at Washington University in St. Louis who teamed with his colleague last year to conduct a trial of fluvoxamine in newly infected covid patients with mild symptoms.

Participants in that early study logged symptoms on a website while taking fluvoxamine or placebo tablets that were mailed to their homes. Fluvoxamine, sold under the brand name , is one of the oldest drugs in the (SSRI) class. It is prescribed for major depression in many countries and was to treat OCD.

The results of the trial, in the Journal of the American Medical Association, showed that none of the 80 fluvoxamine-treated patients became seriously ill, while six of 72 patients who took placebo pills worsened and required hospitalization.

Last month, another journal of a real-world study that echoed the JAMA results: Among 113 horse racetrack workers who were offered fluvoxamine after contracting covid during a Bay Area outbreak, none of the 65 patients who chose to take the drug got sicker, whereas six of 48 people who declined the drug wound up hospitalized, and one died.

The evidence for fluvoxamine — which includes cell and animal data showing that the drug blocks harmful inflammation through a different from the way it treats depression or OCD — puts it “among the more promising non-proven therapies,” Sax said. He is waiting for more definitive results from an ongoing being conducted by the Washington University team. “Based on years of watching therapeutic trials in infectious disease,” Sax said, “a lot of these things turn out to be busts.”

Smaller studies are more likely to overestimate a drug’s effects, said , a biostatistician at Johns Hopkins Bloomberg School of Public Health.

Experiences with several experimental treatments illustrate this word of caution. Earlier in the pandemic, some doctors jumped on early lab data and started treating people with convalescent plasma — blood donated by recovered patients. Enthusiasm for plasma, however, has waned somewhat as the pandemic eased and larger studies suggested it .

Research on the gout drug colchicine caused similar whiplash. A news release in January claimed the drug reduced covid deaths by 44%, but once the full data was released, enthusiasm cooled, said , a physician-scientist at the University of Minnesota Medical School who led several hydroxychloroquine trials that helped disprove that drug’s value in fighting covid.

“It’s tough to weed through what’s real and what’s not,” he said.

With NIH showing little interest in generics, private funders have seized an opportunity. Silicon Valley tech entrepreneur Steve Kirsch launched the last spring to support research on promising outpatient drugs.

Kirsch’s fund helped finance the published fluvoxamine trial and coordinated fundraising for most of the $2 million needed for the current nationwide study. But his zeal gave some the impression that Kirsch was hyping the drug. Newspapers have rejected his op-eds, Facebook took down his posts, and Medium removed Kirsch’s story titled “The Fast, Easy, Safe, Simple, Low-Cost Solution to COVID That Works 100% of the Time That Nobody Wants to Talk About,” and closed his account.

Claims about a drug’s efficacy and safety can be made only after authorization of the product by the FDA for its intended use, said Danzig, who serves as a volunteer medical adviser for Kirsch’s fund. These rules “are not widely known to people in the tech world.”

Agency-level guidelines are slow to change, and for good reason, Boulware said. “If something’s a guideline, and you’re not doing it, that starts to become medical malpractice.”

In the case of fluvoxamine, though, Boulware finds the data promising and hopes the larger trial can be completed quickly. “If this was the first drug that came along and there wasn’t the hydroxychloroquine experience, people would view it very differently,” he said.

Earlier this month, CityHealth Urgent Care, which has two Bay Area clinics and a national telehealth program, began .

Besides the study, other drug repurposing trials are enrolling U.S. patients, including an NIH trial comparing , and separate trials evaluating the diabetes drug or for covid treatment or prevention. Plans are underway for additional trials supported by a . And a multi-site, placebo-controlled trial coordinated by McMaster University in Ontario, Canada, is comparing , in patients with mild covid.

“I think we’re going to get some answers,” said , dean of the Emory School of Medicine. “It just would have been nice to get them sooner.”

This story was produced by , which publishes , an editorially independent service of the .

This <a target="_blank" href="/health-industry/fluvoxamine-antidepressant-covid-treatment-repurposed-drugs-generics/">article</a&gt; first appeared on <a target="_blank" href="">Â鶹ŮÓÅ Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

The picture was different in Beverly Hills, a mostly white suburb 20 miles away. “People I went to high school with aren’t posting anything like that,” Taylor said. “They’re doing well, their family is doing OK. And even the ones whose family members have caught it, they’re still alive.”

How do COVID-19 infection rates and outcomes differ between these ZIP codes? she wondered. How do their hospitals and other resources compare? This summer, as part of an developed by San Francisco researchers and funded by the National Institutes of Health, Taylor will look at that question and other effects of the pandemic. She’s one of 70 participants from backgrounds underrepresented in science who are learning basic coding and data analysis methods to explore disparity issues.

Data to address racial discrepancies in care and outcomes has been spotty during the pandemic, and it isn’t available for most of these students’ communities, which . The participants are “asking questions from a perspective that we desperately need, because their voices aren’t really there in the scientific community,” said , who directs the division of training, workforce development and diversity at the National Institute of General Medical Sciences.

Scientists from Black, Hispanic, Native American and other minority backgrounds have long been underrepresented in biomedicine. By some measures, efforts to diversify the field have made progress: The number of these minorities who earned life science doctoral degrees. But this increase in Ph.D.s has not moved the needle at the faculty level.

Instead, the number of minority assistant professors in these fields has dipped in recent years, from 347 in 2005 to 341 in 2013. And some of those who have entered public health in the workplace — or, after years in a toxic environment, quietly leave.

“We really need to focus on making sure people are supported and find academic and research jobs sufficiently desirable that they choose to stay,” said Gammie. “There have been improvements, but we still have a long way to go.”

In 2014, the NIH launched the initiative. It offers grants to 10 undergraduate campuses that partner with scores of other institutions researching how to get poor and minority students to pursue biomedical careers.

Students in the program receive stipends and typically spend summers working in research labs. But when COVID-19 hit, many labs and their experiments shut down. “People were like, what do we do? How do we do that remotely?” said biologist , who heads the initiative’s team at San Francisco State University.

She and University of California-San Francisco epidemiologist sketched out a plan for students to work remotely with bioinformatics, population health and epidemiology researchers to collect and analyze COVID-19 data for marginalized populations.

Gammie encouraged the Bay Area team to expand the summer opportunity to participants across the nation. From June 22 to Aug. 13, students spend two to three hours online four days a week in small groups led by master’s-level mentors. They learn basic bioinformatics — computational methods for analyzing biological and population health data — and R, a common statistical programming language, to collect and analyze data from public data sets. “I think of basic bioinformatics and R coding as an empowerment tool,” said Mehta. “They’re going to become change agents in their communities, fighting back with data.”

Bench science often takes years, whereas data crunching to solve problems offers a sense of immediacy, said Niquo Ceberio, who recently earned a master’s in biology at SFSU and leads the team of mentors. “There was this sort of limitlessness about it that really appealed to me,” she said.

Raymundo Aragonez, a University of Texas-El Paso biology major participating in the summer program, sees data analysis as a way to address confusion in the Hispanic community — including some of his family members who think the pandemic “is all a hoax.” Dismayed by misleading YouTube videos and rampant misinformation shared on social media, Aragonez, who aims to be the first in his family to finish college, said he hopes to gain skills to “understand the data and how infections are actually happening, so I can explain it to my family.”

He hopes to explore whether COVID-19 infection rates differ among people living in El Paso, those living in the Mexican city of Juárez, and those who frequently cross the

border between the cities — like many of his friends and classmates.

Willow Weibel, an SFSU psychology major, is studying how COVID-19 restrictions affect the mental health of former foster youth and other young adults with traumatic backgrounds. Weibel spent much of her childhood in foster care before getting adopted into a Southern California family at age 17. “I’ve grown to really care about what other people go through in the system,” she said.

Mental health is a common thread in the research questions proposed by several students in Weibel’s group, including Skye Taylor, who is majoring in psychology with a minor in public health. While curious about disparities in Detroit-area COVID-19 outcomes, she also wants to examine how mental health issues affect COVID-19 susceptibility — “especially in the Black community, because mental health isn’t really talked about,” she said.

Having the chance to explore their own research questions is unusual for undergraduates, and particularly meaningful to students of color. “It feels like science is something that’s been done to us or on us,” said Ceberio, who is Black and Latina, and grew up in Los Angeles, Miami and Las Vegas before moving to the Bay Area. “This experience allows them to do research that they feel is relevant based on the way they’re viewing the world. I’m trying to get them to trust their instincts.”

Trainees from underrepresented groups will more likely stay in biomedicine if they feel they are giving back to their communities or doing something with a tangible purpose, said Gammie. This summer, participants “have an opportunity to engage in science that does both,” she said. “Our hope is that this will inspire students to go on to be independent scientists.”

This <a target="_blank" href="/mental-health/turning-anger-into-action-minority-students-analyze-covid-data-on-racial-disparities/">article</a&gt; first appeared on <a target="_blank" href="">Â鶹ŮÓÅ Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

It’s an exciting notion: A $10, two-week course of this drug could reduce death and hospitalizations. The drug could be used to fight ongoing outbreaks in the United States and would be a particular godsend for lower-income countries that may have to wait years for vaccines against the virus. But fluvoxamine, as well as other old drugs showing potential against covid, face hurdles to full evaluations.

Drug companies have no incentive to spend millions to test new uses for cheap, off-patent drugs. Chances are slim that any drug, even one showing promise in early trials, would provide a major benefit. And early enthusiasm for covid treatments that later flopped has “made people gun-shy,” said , a professor of preventive medicine at the University of Southern California.

In particular, former President Donald Trump’s premature promotion of hydroxychloroquine likely stymied efforts to find other generic cures. The Food and Drug Administration granted emergency use of the malaria drug in March, then revoked the authorization less than three months later after evidence showed it was more likely to harm than help patients.

“We doctors who want to use evidence-based medicine feel somewhat burned by the hydroxychloroquine experience and really want to see good studies before we actually jump on the bandwagon,” said , clinical director of the division of infectious diseases at Brigham and Women’s Hospital in Boston.

And that poses a Catch-22. , the National Institutes of Health, the world’s largest public funder of biomedical research, has shown little interest in studies of repurposed drugs. Without big money, it’s hard to do the research needed to show whether existing treatments could work against covid.

As a result, efforts to repurpose drugs have fallen to philanthropists, some in the Bay Area. “We’re missing out on public health benefits of the drugs we already have because we’re relying almost entirely on capitalism and private industry to make advances,” said Elaine Lissner, founder of the San Francisco-based , which is supporting covid research on fluvoxamine and other low-cost oral drugs.

Repurposing is a long shot, yet compared to creating drugs and vaccines, the approach has clear advantages during a fast-moving pandemic. “If it works and it’s on the shelf, you don’t have any development time,” said , a specialist in infectious diseases who consults with companies, investors, government and philanthropies. One of the best treatments in the covid arsenal — the common steroid dexamethasone — is a repurposed drug. But it is recommended only for hospitalized patients who are seriously ill.

Danzig was “very excited” last April by news that a team led by University of California-San Francisco researchers had that, when used early on, could counteract infections with SARS-CoV-2, the virus that causes covid. “I’m thinking, if we can rapidly test some of these in clinical trials, we can have answers by October.”

Yet these studies . Solid covid trials of early treatments are particularly hard to pull off. Patients often must enroll within days of noticing symptoms. And without a national research infrastructure, “it’s hard to get anyone’s attention to participate in a trial or refer to it,” said , a psychiatrist at Washington University in St. Louis who teamed with his colleague last year to conduct a trial of fluvoxamine in newly infected covid patients with mild symptoms.

Participants in that early study logged symptoms on a website while taking fluvoxamine or placebo tablets that were mailed to their homes. Fluvoxamine, sold under the brand name , is one of the oldest drugs in the (SSRI) class. It is prescribed for major depression in many countries and was to treat OCD.

The results of the trial, in the Journal of the American Medical Association, showed that none of the 80 fluvoxamine-treated patients became seriously ill, while six of 72 patients who took placebo pills worsened and required hospitalization.

Last month, another journal of a real-world study that echoed the JAMA results: Among 113 horse racetrack workers who were offered fluvoxamine after contracting covid during a Bay Area outbreak, none of the 65 patients who chose to take the drug got sicker, whereas six of 48 people who declined the drug wound up hospitalized, and one died.

The evidence for fluvoxamine — which includes cell and animal data showing that the drug blocks harmful inflammation through a different from the way it treats depression or OCD — puts it “among the more promising non-proven therapies,” Sax said. He is waiting for more definitive results from an ongoing being conducted by the Washington University team. “Based on years of watching therapeutic trials in infectious disease,” Sax said, “a lot of these things turn out to be busts.”

Smaller studies are more likely to overestimate a drug’s effects, said , a biostatistician at Johns Hopkins Bloomberg School of Public Health.

Experiences with several experimental treatments illustrate this word of caution. Earlier in the pandemic, some doctors jumped on early lab data and started treating people with convalescent plasma — blood donated by recovered patients. Enthusiasm for plasma, however, has waned somewhat as the pandemic eased and larger studies suggested it .

Research on the gout drug colchicine caused similar whiplash. A news release in January claimed the drug reduced covid deaths by 44%, but once the full data was released, enthusiasm cooled, said , a physician-scientist at the University of Minnesota Medical School who led several hydroxychloroquine trials that helped disprove that drug’s value in fighting covid.

“It’s tough to weed through what’s real and what’s not,” he said.

With NIH showing little interest in generics, private funders have seized an opportunity. Silicon Valley tech entrepreneur Steve Kirsch launched the last spring to support research on promising outpatient drugs.

Kirsch’s fund helped finance the published fluvoxamine trial and coordinated fundraising for most of the $2 million needed for the current nationwide study. But his zeal gave some the impression that Kirsch was hyping the drug. Newspapers have rejected his op-eds, Facebook took down his posts, and Medium removed Kirsch’s story titled “The Fast, Easy, Safe, Simple, Low-Cost Solution to COVID That Works 100% of the Time That Nobody Wants to Talk About,” and closed his account.

Claims about a drug’s efficacy and safety can be made only after authorization of the product by the FDA for its intended use, said Danzig, who serves as a volunteer medical adviser for Kirsch’s fund. These rules “are not widely known to people in the tech world.”

Agency-level guidelines are slow to change, and for good reason, Boulware said. “If something’s a guideline, and you’re not doing it, that starts to become medical malpractice.”

In the case of fluvoxamine, though, Boulware finds the data promising and hopes the larger trial can be completed quickly. “If this was the first drug that came along and there wasn’t the hydroxychloroquine experience, people would view it very differently,” he said.

Earlier this month, CityHealth Urgent Care, which has two Bay Area clinics and a national telehealth program, began .

Besides the study, other drug repurposing trials are enrolling U.S. patients, including an NIH trial comparing , and separate trials evaluating the diabetes drug or for covid treatment or prevention. Plans are underway for additional trials supported by a . And a multi-site, placebo-controlled trial coordinated by McMaster University in Ontario, Canada, is comparing , in patients with mild covid.

“I think we’re going to get some answers,” said , dean of the Emory School of Medicine. “It just would have been nice to get them sooner.”

This story was produced by , which publishes , an editorially independent service of the .

This <a target="_blank" href="/health-industry/fluvoxamine-antidepressant-covid-treatment-repurposed-drugs-generics/">article</a&gt; first appeared on <a target="_blank" href="">Â鶹ŮÓÅ Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">

The picture was different in Beverly Hills, a mostly white suburb 20 miles away. “People I went to high school with aren’t posting anything like that,” Taylor said. “They’re doing well, their family is doing OK. And even the ones whose family members have caught it, they’re still alive.”

How do COVID-19 infection rates and outcomes differ between these ZIP codes? she wondered. How do their hospitals and other resources compare? This summer, as part of an developed by San Francisco researchers and funded by the National Institutes of Health, Taylor will look at that question and other effects of the pandemic. She’s one of 70 participants from backgrounds underrepresented in science who are learning basic coding and data analysis methods to explore disparity issues.

Data to address racial discrepancies in care and outcomes has been spotty during the pandemic, and it isn’t available for most of these students’ communities, which . The participants are “asking questions from a perspective that we desperately need, because their voices aren’t really there in the scientific community,” said , who directs the division of training, workforce development and diversity at the National Institute of General Medical Sciences.

Scientists from Black, Hispanic, Native American and other minority backgrounds have long been underrepresented in biomedicine. By some measures, efforts to diversify the field have made progress: The number of these minorities who earned life science doctoral degrees. But this increase in Ph.D.s has not moved the needle at the faculty level.

Instead, the number of minority assistant professors in these fields has dipped in recent years, from 347 in 2005 to 341 in 2013. And some of those who have entered public health in the workplace — or, after years in a toxic environment, quietly leave.

“We really need to focus on making sure people are supported and find academic and research jobs sufficiently desirable that they choose to stay,” said Gammie. “There have been improvements, but we still have a long way to go.”

In 2014, the NIH launched the initiative. It offers grants to 10 undergraduate campuses that partner with scores of other institutions researching how to get poor and minority students to pursue biomedical careers.

Students in the program receive stipends and typically spend summers working in research labs. But when COVID-19 hit, many labs and their experiments shut down. “People were like, what do we do? How do we do that remotely?” said biologist , who heads the initiative’s team at San Francisco State University.

She and University of California-San Francisco epidemiologist sketched out a plan for students to work remotely with bioinformatics, population health and epidemiology researchers to collect and analyze COVID-19 data for marginalized populations.

Gammie encouraged the Bay Area team to expand the summer opportunity to participants across the nation. From June 22 to Aug. 13, students spend two to three hours online four days a week in small groups led by master’s-level mentors. They learn basic bioinformatics — computational methods for analyzing biological and population health data — and R, a common statistical programming language, to collect and analyze data from public data sets. “I think of basic bioinformatics and R coding as an empowerment tool,” said Mehta. “They’re going to become change agents in their communities, fighting back with data.”

Bench science often takes years, whereas data crunching to solve problems offers a sense of immediacy, said Niquo Ceberio, who recently earned a master’s in biology at SFSU and leads the team of mentors. “There was this sort of limitlessness about it that really appealed to me,” she said.

Raymundo Aragonez, a University of Texas-El Paso biology major participating in the summer program, sees data analysis as a way to address confusion in the Hispanic community — including some of his family members who think the pandemic “is all a hoax.” Dismayed by misleading YouTube videos and rampant misinformation shared on social media, Aragonez, who aims to be the first in his family to finish college, said he hopes to gain skills to “understand the data and how infections are actually happening, so I can explain it to my family.”

He hopes to explore whether COVID-19 infection rates differ among people living in El Paso, those living in the Mexican city of Juárez, and those who frequently cross the

border between the cities — like many of his friends and classmates.

Willow Weibel, an SFSU psychology major, is studying how COVID-19 restrictions affect the mental health of former foster youth and other young adults with traumatic backgrounds. Weibel spent much of her childhood in foster care before getting adopted into a Southern California family at age 17. “I’ve grown to really care about what other people go through in the system,” she said.

Mental health is a common thread in the research questions proposed by several students in Weibel’s group, including Skye Taylor, who is majoring in psychology with a minor in public health. While curious about disparities in Detroit-area COVID-19 outcomes, she also wants to examine how mental health issues affect COVID-19 susceptibility — “especially in the Black community, because mental health isn’t really talked about,” she said.

Having the chance to explore their own research questions is unusual for undergraduates, and particularly meaningful to students of color. “It feels like science is something that’s been done to us or on us,” said Ceberio, who is Black and Latina, and grew up in Los Angeles, Miami and Las Vegas before moving to the Bay Area. “This experience allows them to do research that they feel is relevant based on the way they’re viewing the world. I’m trying to get them to trust their instincts.”

Trainees from underrepresented groups will more likely stay in biomedicine if they feel they are giving back to their communities or doing something with a tangible purpose, said Gammie. This summer, participants “have an opportunity to engage in science that does both,” she said. “Our hope is that this will inspire students to go on to be independent scientists.”

This <a target="_blank" href="/mental-health/turning-anger-into-action-minority-students-analyze-covid-data-on-racial-disparities/">article</a&gt; first appeared on <a target="_blank" href="">Â鶹ŮÓÅ Health News</a> and is republished here under a <a target="_blank" href=" Commons Attribution-NonCommercial-NoDerivatives 4.0 International License</a>.<img src="/wp-content/uploads/sites/8/2023/04/kffhealthnews-icon.png?w=150&quot; style="width:1em;height:1em;margin-left:10px;">