FDA Issues Emergency Authorization to Treat COVID-19 With Malaria Drugs

The U.S. Food and Drug Administration has approved the use of two malarial drugs to treat and prevent COVID-19, the respiratory infection caused by the SARS-CoV-2 coronavirus, despite only anecdotal evidence that either is proven effective in treating or slowing the progression of the disease in seriously ill patients.
Under the emergency use authorization (EUA), millions of doses will be made available to doctors' patients through a Strategic National Stockpile "to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible," announced the U.S. Department of Health and Human Services in a statement.
In laboratory studies, the oral prescription drugs have shown "activity" against coronaviruses, including SARS-CoV-2. As of now, the drugs are only approved to treat malaria and other diseases like arthritis.
"Clinical trials are needed to provide scientific evidence that these treatments are effective," adds DHHS. To determine whether either drug may be effective against the virus, a number of studies are currently ongoing. At the University of Washington, for example, researchers are working to determine whether hydroxychloroquine can prevent transmission in people exposed to the virus.
"We currently don't know if hydroxychloroquine works, but we will learn in as short a timeframe as possible what the outcome is," said principal investigator Ruanne Barnabas, associate professor of global health in the University of Washington schools of Medicine and Public Health. The Centers for Disease Control and Preventions (CDC) adds that hydroxychloroquine is available by prescription only and may react with other drugs. As such, it should be used under the discretion of a doctor.
Similarly, chloroquine phosphate is only available in the U.S. by prescription for the treatment of malaria, according to the CDC. In recent weeks, several studies aimed at understanding the efficacy and safety of chloroquine found that there is "pre-clinical evidence of effectiveness and evidence of safety from long-term clinical use."
However, neither drug has been approved yet for treating or preventing COVID-19. The CDC has warned against the misuse of chloroquine without direction of a doctor after at least two people who ingested non-pharmaceutical chloroquine phosphate – used in aquarium and available for purchase for use in aquariums and online.
On average, it takes 12 years for the FDA to approve a new drug. For existing drugs that have already undergone safety studies, that timeframe may vary. Generally, FDA approval comes in three phases: the first which tests safety in humans and lasts about a year, the second that assesses the drug's effectiveness and takes about two years, and the third which monitors and evaluates effectiveness and adverse reactions in a large population, which requires three years. The fast-track is in response to the rapidly increasing cases and death rate currently being seen in COVID-19 cases, allowing doctors and patients have access to "unapproved medical countermeasure or unapproved uses" of these measures to "prepare for and respond to chemical, biological, radiological, and nuclear threats."
"An EUA may be issued if the FDA determines that, among other criteria, the known and potential benefits of the product, when used to diagnose, prevent, or treat the identified disease or condition, outweigh the known and potential risks of the product, and there are no adequate, approved, available alternatives. Emergency access to a medical product under an EUA is separate from use of a medical product under an investigational drug application," adds the DHHS.
The FDA concludes that the EUA will require that fact sheets be provided to healthcare providers and patients about using chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19, which includes the risks and possible drug interactions.
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By Katy Neusteter
The Biden-Harris transition team identified COVID-19, economic recovery, racial equity and climate change as its top priorities. Rivers are the through-line linking all of them. The fact is, healthy rivers can no longer be separated into the "nice-to-have" column of environmental progress. Rivers and streams provide more than 60 percent of our drinking water — and a clear path toward public health, a strong economy, a more just society and greater resilience to the impacts of the climate crisis.
Public Health
<img lazy-loadable="true" data-runner-src="https://assets.rebelmouse.io/eyJhbGciOiJIUzI1NiIsInR5cCI6IkpXVCJ9.eyJpbWFnZSI6Imh0dHBzOi8vYXNzZXRzLnJibC5tcy8yNTUyNDY3MC9vcmlnaW4uanBnIiwiZXhwaXJlc19hdCI6MTY2MDkxMTkwNn0.pyP14Bg1WvcUvF_xUGgYVu8PS7Lu49Huzc3PXGvATi4/img.jpg?width=980" id="8e577" class="rm-shortcode" data-rm-shortcode-id="1efb3445f5c445e47d5937a72343c012" data-rm-shortcode-name="rebelmouse-image" data-width="3000" data-height="2302" />Wild and Scenic Merced River, California. Bob Wick / BLM
<p>Let's begin with COVID-19. More than <a href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?name=styln-coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&impression_id=2f508610-2a87-11eb-8622-4f6c038cbd1d&variant=1_Show" target="_blank">16 million Americans</a> have contracted the coronavirus and, tragically,<a href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?name=styln-coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&impression_id=2f508610-2a87-11eb-8622-4f6c038cbd1d&variant=1_Show" target="_blank"> more than</a> <a href="https://www.nytimes.com/interactive/2020/us/coronavirus-us-cases.html?name=styln-coronavirus&region=TOP_BANNER&block=storyline_menu_recirc&action=click&pgtype=LegacyCollection&impression_id=2f508610-2a87-11eb-8622-4f6c038cbd1d&variant=1_Show" target="_blank">300,000 have died</a> due to the pandemic. While health officials encourage hand-washing to contain the pandemic, at least <a href="https://closethewatergap.org/" target="_blank">2 million Americans</a> are currently living without running water, indoor plumbing or wastewater treatment. Meanwhile, <a href="https://www.theguardian.com/us-news/2020/jun/23/millions-of-americans-cant-afford-water-bills-rise" target="_blank">aging water infrastructure is growing increasingly costly for utilities to maintain</a>. That cost is passed along to consumers. The upshot? <a href="https://research.msu.edu/affordable-water-in-us-reaching-a-crisis/" target="_blank">More than 13 million</a> U.S. households regularly face unaffordable water bills — and, thus, the threat of water shutoffs. Without basic access to clean water, families and entire communities are at a higher risk of <a href="https://www.americanprogress.org/issues/green/news/2020/08/05/488705/bridging-water-access-gap-covid-19-relief/" target="_blank">contracting</a> and spreading COVID-19.</p><p>We have a moral duty to ensure that everyone has access to clean water to help prevent the spread of the coronavirus. Last spring, <a href="https://nymag.com/intelligencer/2020/03/coronavirus-stimulus-bill-explained-bailouts-unemployment-benefits.html" target="_blank">Congress appropriated more than $4 trillion</a> to jumpstart the economy and bring millions of unemployed Americans back to work. Additional federal assistance — desperately needed — will present a historic opportunity to improve our crumbling infrastructure, which has been <a href="https://www.theguardian.com/us-news/2020/jun/23/millions-of-americans-cant-afford-water-bills-rise" target="_blank" rel="noopener noreferrer">grossly underfunded for decades</a>.</p><p>A report by my organization, American Rivers, suggests that <a href="https://s3.amazonaws.com/american-rivers-website/wp-content/uploads/2020/07/09223525/ECONOMIC-ENGINES-Report-2020.pdf" target="_blank" rel="noopener noreferrer">Congress must invest at least $50 billion</a> "to address the urgent water infrastructure needs associated with COVID-19," including the rising cost of water. This initial boost would allow for the replacement and maintenance of sewers, stormwater infrastructure and water supply facilities.</p>Economic Recovery
<p>Investing in water infrastructure and healthy rivers also creates jobs. Consider, for example, that <a href="https://tinyurl.com/y9p6sgnk" target="_blank">every $1 million spent on water infrastructure in the United States generates more than 15 jobs</a> throughout the economy, according to a report by the Value of Water Campaign. Similarly, <a href="https://tinyurl.com/yyvd2ksp" target="_blank">every "$1 million invested in forest and watershed restoration contracting will generate between 15.7 and 23.8 jobs,</a> depending on the work type," states a working paper released by the Ecosystem Workforce Program, University of Oregon. Healthy rivers also spur tourism and recreation, which many communities rely on for their livelihoods. According to the findings by the Outdoor Industry Association, which have been shared in our report, "Americans participating in watersports and fishing spend over <a href="https://s3.amazonaws.com/american-rivers-website/wp-content/uploads/2020/06/30222425/Exec-summary-ECONOMIC-ENGINES-Report-June-30-2020.pdf" target="_blank">$174 billion</a> on gear and trip related expenses. And, the outdoor watersports and fishing economy supports over <a href="https://s3.amazonaws.com/american-rivers-website/wp-content/uploads/2020/06/30222425/Exec-summary-ECONOMIC-ENGINES-Report-June-30-2020.pdf" target="_blank">1.5 million jobs nationwide</a>."</p><p>After the 2008 financial crisis, Congress invested in infrastructure to put Americans back to work. The American Recovery and Reinvestment Act <a href="https://thehill.com/blogs/congress-blog/economy-a-budget/25941-clean-water-green-infrastructure-get-major-boost" target="_blank">of 2009 (ARRA) allocated $6 billion</a> for clean water and drinking water infrastructure to decrease unemployment and boost the economy. More specifically, <a href="https://www.conservationnw.org/news-updates/us-reps-push-for-millions-of-restoration-and-resilience-jobs/" target="_blank" rel="noopener noreferrer">an analysis of ARRA</a> "showed conservation investments generated 15 to 33 jobs per million dollars," and more than doubled the rate of return, according to a letter written in May 2020 by 79 members of Congress, seeking greater funding for restoration and resilience jobs.</p><p>Today, when considering how to create work for the <a href="https://www.bls.gov/news.release/pdf/empsit.pdf" target="_blank" rel="noopener noreferrer">10.7 million</a> people who are currently unemployed, Congress should review previous stimulus investments and build on their successes by embracing major investments in water infrastructure and watershed restoration.</p>Racial Justice
<p>American Rivers also recommends that Congress dedicate <a href="https://s3.amazonaws.com/american-rivers-website/wp-content/uploads/2020/07/09223525/ECONOMIC-ENGINES-Report-2020.pdf" target="_blank" rel="noopener noreferrer">$500 billion for rivers and clean water over the next 10 years</a> — not just for the benefit of our environment and economy, but also to begin to address the United States' history of deeply entrenched racial injustice.</p><p>The <a href="https://www.epa.gov/npdes/sanitary-sewer-overflows-ssos" target="_blank" rel="noopener noreferrer">23,000-75,000 sewer overflows</a> that occur each year release up to <a href="https://www.americanrivers.org/2020/05/fighting-for-rivers-means-fighting-for-justice/#:~:text=There%20are%20also%2023%2C000%20to%2075%2C000%20sanitary%20sewer,to%20do%20with%20the%20mission%20of%20American%20Rivers." target="_blank" rel="noopener noreferrer">10 billion gallons of toxic sewage</a> <em>every day</em> into rivers and streams. This disproportionately impacts communities of color, because, for generations, Black, Indigenous, Latinx and other people of color have been <a href="https://www.scientificamerican.com/article/flooding-disproportionately-harms-black-neighborhoods/" target="_blank" rel="noopener noreferrer">relegated</a> to live in flood-prone areas and in neighborhoods that have been intentionally burdened with a lack of development that degrades people's health and quality of life. In some communities of color, incessant flooding due to stormwater surges or <a href="https://www.ajc.com/opinion/opinion-partnering-to-better-manage-our-water/7WQ6SEAQP5E4LGQCEYY5DO334Y/" target="_blank" rel="noopener noreferrer">combined sewer overflows</a> has gone unmitigated for decades.</p><p>We have historically treated people as separate from rivers and water. We can't do that anymore. Every voice — particularly those of people most directly impacted — must have a loudspeaker and be included in decision-making at the highest levels.</p><p>Accordingly, the new administration must diligently invest in projects at the community level that will improve lives in our country's most marginalized communities. We also must go further to ensure that local leaders have a seat at the decision-making table. To this end, the Biden-Harris administration should restore <a href="https://www.epa.gov/cwa-401#:~:text=Section%20401%20Certification%20The%20Clean%20Water%20Act%20%28CWA%29,the%20United%20States.%20Learn%20more%20about%20401%20certification." target="_blank">Section 401 of the Clean Water Act</a>, which was undermined by the <a href="https://earthjustice.org/news/press/2020/tribes-and-environmental-groups-sue-trump-administration-to-preserve-clean-water-protections#:~:text=Under%20Section%20401%20of%20the%20Clean%20Water%20Act%2C,seeks%20to%20undermine%20that%20authority%20in%20several%20ways%3A" target="_blank">Trump administration's 2020 regulatory changes</a>. This provision gives states and tribes the authority to decide whether major development projects, such as hydropower and oil and gas projects, move forward.</p>Climate Resilience
<p>Of course, the menacing shadow looming over it all? Climate change. <a href="https://media.ifrc.org/ifrc/wp-content/uploads/2020/11/IFRC_wdr2020/IFRC_WDR_ExecutiveSummary_EN_Web.pdf" target="_blank">More than 100 climate-related catastrophes</a> have pummeled the Earth since the pandemic was declared last spring, including the blitzkrieg of megafires, superstorms and heat waves witnessed during the summer of 2020, directly impacting the lives of more than <a href="https://media.ifrc.org/ifrc/wp-content/uploads/2020/11/IFRC_wdr2020/IFRC_WDR_ExecutiveSummary_EN_Web.pdf" target="_blank">50 million people globally</a>.</p><p>Water and climate scientist Brad Udall often says, "<a href="https://www.youtube.com/watch?v=xQhpj5G0dME" target="_blank">Climate change is water change</a>." In other words, the most obvious and dire impacts of climate change are evidenced in profound changes to our rivers and water resources. You've likely seen it where you live: Floods are more damaging and frequent. Droughts are deeper and longer. Uncertainty is destabilizing industry and lives.</p><p>By galvanizing action for healthy rivers and managing our water resources more effectively, we can insure future generations against the consequences of climate change. First, we must safeguard rivers that are still healthy and free-flowing. Second, we must protect land and property against the ravages of flooding. And finally, we must promote policies and practical solutions that take the science of climate disruption into account when planning for increased flooding, water shortage and habitat disruption.</p><p>Imagine all that rivers do for us. Most of our towns and cities have a river running through them or flowing nearby. Rivers provide clean drinking water, irrigate crops that provide our food, power our homes and businesses, provide wildlife habitat, and are the lifeblood of the places where we enjoy and explore nature, and where we play and nourish our spirits. Healthy watersheds help <a href="https://news.un.org/en/story/2020/03/1059952" target="_blank" rel="noopener noreferrer">mitigate</a> climate change, absorbing and reducing the amount of carbon in the atmosphere. Healthy rivers and floodplains help communities adapt and build resilience in the face of climate change by improving flood protection and providing water supply and quality benefits. Rivers are the cornerstones of healthy, strong communities.</p><p>The more than <a href="https://archive.epa.gov/water/archive/web/html/index-17.html" target="_blank" rel="noopener noreferrer">3 million miles</a> of rivers and streams running across our country are a source of great strength and opportunity. When we invest in healthy rivers and clean water, we can improve our lives. When we invest in rivers, we create jobs and strengthen our economy. When we invest in rivers, we invest in our shared future.</p>EcoWatch Daily Newsletter
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