Monday, April 13, 2020
Former FDA leaders decry emergency authorization of malaria drugs for coronavirus
After U.S. President Donald Trump advocated widespread use of two malaria drugs for COVID-19 patients, the Food and Drug Administration, led by Commissioner Stephen Hahn (left) produced an emergency use authorization for the medications.YURI GRIPAS/ABACA/SIPA VIA AP IMAGES
By Charles Piller Apr. 7, 2020 , 6:20 PM
Science’s COVID-19 reporting is supported by the Pulitzer Center.
The recent Food and Drug Administration (FDA) emergency use authorization (EUA) for two malaria drugs to treat COVID-19, based on thin evidence of efficacy, has jeopardized research to learn the drugs’ real value against the pandemic coronavirus, say former agency executives under President Donald Trump and former President Barack Obama. They also charge that the 28 March EUA for chloroquine phosphate and hydroxychloroquine sulfate undermines FDA’s scientific authority because it appeared to be a response not to scientific evidence, but to fervent advocacy of the drugs by Trump and other political figures.
FDA has multiple mechanisms to allow the use of unapproved, experimental drugs for small numbers of desperately ill patients outside of clinical trials. Because chloroquine and hydroxychloroquine are approved for malaria, doctors could prescribe them “off label” for COVID-19 patients even without the EUA. Since Trump first endorsed the drugs on 19 March, however, shortages have been reported, depriving some people with autoimmune disorders such as lupus who also depend on hydroxychloroquine. The EUA will immediately add tens of millions of doses of the drugs for distribution to hospitalized COVID-19 patients through health care centers.
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Trump has suggested the EUA was needed because effective clinical trials of the drugs would take too long during the global crisis. At a 5 April news conference, he said: “We don’t have time to go and say, ‘Gee, let’s take a couple of years and test it out, and let’s go and test with the test tubes and the laboratories.’”
“I’d love to do that, but we have people dying today,” he added.
Scott Gottlieb, FDA commissioner under Trump until last year, has consistently called for more research on the efficacy of hydroxychloroquine, with or without the antibiotic azithromycin. “If the drug combo is working its effect is probably subtle enough that only rigorous and large-scale trials will tease it out,” he tweeted on 5 April.
Margaret Hamburg, FDA commissioner during most of Obama’s tenure, including the H1N1, Zika, and Ebola crises, says she was “surprised and perturbed” by the EUA. “I understand the desire to find hope, but we need more evidence than is currently available before we encourage widespread use,” says Hamburg, who is a past president of AAAS, which publishes ScienceInsider. Valuable clinical trial evidence on the two malaria drugs could be gathered in a few weeks, Hamburg adds—but the EUA could make that more difficult. “Making the drugs available in a more widespread way might actually interfere with the ability to get the data that we need.”
Since 2005, FDA has issued EUAs more than 100 times, mostly for diagnostic tests to detect emerging pathogens, including 34 such authorizations for tests for the novel coronavirus that causes COVID-19. (Here’s a table of all EUAs.) The recent authorizations for the use of chloroquine and hydroxychloroquine, based on what FDA cited as “limited in-vitro and anecdotal clinical data in case series,” and Chinese and South Korean COVID-19 treatment guidelines, fell below earlier standards for therapeutic EUAs, Hamburg and others say. In contrast, the European Medicines Agency called for use of the drugs only in clinical trials or for emergency use as defined by each nation’s policies.
The only comparable EUAs—an antibiotic to treat anthrax in 2011 and antiviral drugs to treat the pandemic H1N1 influenza virus in 2009—enjoyed far stronger evidence of safety and efficacy, former FDA officials say. Even then, one of the drugs authorized for use on H1N1 turned out to be ineffective.
EUAs might prove crucial in the new pandemic, but only if credible, says Luciana Borio, a former FDA acting chief scientist who directed medical and biodefense preparedness for Trump’s National Security Council. “You want the EUA to be seen by the public as a step the government is taking to facilitate access to a product that they truly believe has benefits that outweigh the risks. Not, ‘We’re not sure,’” says Borio, who was part of a team set up under Obama to coordinate actions to fight pandemics that was eliminated by the Trump administration during a 2018 reorganization.
Making the drugs available in a more widespread way might actually interfere with the ability to get the data that we need.
Margaret Hamburg, former FDA commissioner
Although the World Health Organization last month deemed the two malaria drugs worthy of
being tested in rapidly organized global COVID-19 treatment trials, the push to use hydroxychloroquine—it’s considered a relatively safe form of chloroquine—on a mass scale in the United States came after a tweet from Trump. On 21 March, he said that when taken with azithromycin, the drug has “a real chance to be one of the biggest game changers in the history of medicine.” Trump cited a small French trial of 42 COVID-19 patients that has been criticized for lapses widely viewed as rendering its findings unreliable. Even the International Society of Antimicrobial Chemotherapy, publisher of the peer-reviewed journal that released the study, recently said it “does not meet the Society’s expected standard.”
FDA Commissioner Stephen Hahn initially tried to temper the president’s enthusiasm, calling for clinical trials as a first step at a 19 March news conference. Nine days later, with those trials ramping up, the EUA authorized health care centers to draw on the Strategic National Stockpile’s massive supply of the drugs for “treatment of COVID-19 when clinical trials are not available, or participation is not feasible.” FDA said that in the absence of approved or available alternatives for treating COVID-19, the drugs’ “known and potential benefits … outweigh the known and potential risks.”
FDA Chief Scientist Denise Hinton, who signed the EAU, did not respond to a request for comment. An FDA spokesperson wrote in an email that the EUA was not a response to Trump’s prodding. Instead, the spokesperson said, it was prepared by career staff who consulted with the relevant federal agencies, and was based on “studies in countries including China, Korea, and France.” Two small Chinese trials, which many infectious disease researchers and clinicians regard as more scientifically sound than the French study Trump tweeted about, reached opposite conclusions. In one, COVID-19 patients taking hydroxychloroquine had better outcomes, and in the other, those who received a placebo improved more. A second small French trial found hydroxychloroquine plus azithromycin ineffective for severely ill COVID-19 patients.
Borio, now a vice president at In-Q-Tel, a national security–oriented venture capital firm, adds that FDA, in issuing the EUA, also overlooked the drugs’ record against other viruses. She cites a “long history of having tried hydroxychloroquine as a treatment for emerging viral infections, and seeing it fail to help patients despite some activity in vitro and even in animal models.”
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Trump has suggested the EUA was needed because effective clinical trials of the drugs would take too long during the global crisis. At a 5 April news conference, he said: “We don’t have time to go and say, ‘Gee, let’s take a couple of years and test it out, and let’s go and test with the test tubes and the laboratories.’”
“I’d love to do that, but we have people dying today,” he added.
Scott Gottlieb, FDA commissioner under Trump until last year, has consistently called for more research on the efficacy of hydroxychloroquine, with or without the antibiotic azithromycin. “If the drug combo is working its effect is probably subtle enough that only rigorous and large-scale trials will tease it out,” he tweeted on 5 April.
Margaret Hamburg, FDA commissioner during most of Obama’s tenure, including the H1N1, Zika, and Ebola crises, says she was “surprised and perturbed” by the EUA. “I understand the desire to find hope, but we need more evidence than is currently available before we encourage widespread use,” says Hamburg, who is a past president of AAAS, which publishes ScienceInsider. Valuable clinical trial evidence on the two malaria drugs could be gathered in a few weeks, Hamburg adds—but the EUA could make that more difficult. “Making the drugs available in a more widespread way might actually interfere with the ability to get the data that we need.”
Since 2005, FDA has issued EUAs more than 100 times, mostly for diagnostic tests to detect emerging pathogens, including 34 such authorizations for tests for the novel coronavirus that causes COVID-19. (Here’s a table of all EUAs.) The recent authorizations for the use of chloroquine and hydroxychloroquine, based on what FDA cited as “limited in-vitro and anecdotal clinical data in case series,” and Chinese and South Korean COVID-19 treatment guidelines, fell below earlier standards for therapeutic EUAs, Hamburg and others say. In contrast, the European Medicines Agency called for use of the drugs only in clinical trials or for emergency use as defined by each nation’s policies.
The only comparable EUAs—an antibiotic to treat anthrax in 2011 and antiviral drugs to treat the pandemic H1N1 influenza virus in 2009—enjoyed far stronger evidence of safety and efficacy, former FDA officials say. Even then, one of the drugs authorized for use on H1N1 turned out to be ineffective.
EUAs might prove crucial in the new pandemic, but only if credible, says Luciana Borio, a former FDA acting chief scientist who directed medical and biodefense preparedness for Trump’s National Security Council. “You want the EUA to be seen by the public as a step the government is taking to facilitate access to a product that they truly believe has benefits that outweigh the risks. Not, ‘We’re not sure,’” says Borio, who was part of a team set up under Obama to coordinate actions to fight pandemics that was eliminated by the Trump administration during a 2018 reorganization.
Making the drugs available in a more widespread way might actually interfere with the ability to get the data that we need.
Margaret Hamburg, former FDA commissioner
Although the World Health Organization last month deemed the two malaria drugs worthy of
being tested in rapidly organized global COVID-19 treatment trials, the push to use hydroxychloroquine—it’s considered a relatively safe form of chloroquine—on a mass scale in the United States came after a tweet from Trump. On 21 March, he said that when taken with azithromycin, the drug has “a real chance to be one of the biggest game changers in the history of medicine.” Trump cited a small French trial of 42 COVID-19 patients that has been criticized for lapses widely viewed as rendering its findings unreliable. Even the International Society of Antimicrobial Chemotherapy, publisher of the peer-reviewed journal that released the study, recently said it “does not meet the Society’s expected standard.”
FDA Commissioner Stephen Hahn initially tried to temper the president’s enthusiasm, calling for clinical trials as a first step at a 19 March news conference. Nine days later, with those trials ramping up, the EUA authorized health care centers to draw on the Strategic National Stockpile’s massive supply of the drugs for “treatment of COVID-19 when clinical trials are not available, or participation is not feasible.” FDA said that in the absence of approved or available alternatives for treating COVID-19, the drugs’ “known and potential benefits … outweigh the known and potential risks.”
FDA Chief Scientist Denise Hinton, who signed the EAU, did not respond to a request for comment. An FDA spokesperson wrote in an email that the EUA was not a response to Trump’s prodding. Instead, the spokesperson said, it was prepared by career staff who consulted with the relevant federal agencies, and was based on “studies in countries including China, Korea, and France.” Two small Chinese trials, which many infectious disease researchers and clinicians regard as more scientifically sound than the French study Trump tweeted about, reached opposite conclusions. In one, COVID-19 patients taking hydroxychloroquine had better outcomes, and in the other, those who received a placebo improved more. A second small French trial found hydroxychloroquine plus azithromycin ineffective for severely ill COVID-19 patients.
Borio, now a vice president at In-Q-Tel, a national security–oriented venture capital firm, adds that FDA, in issuing the EUA, also overlooked the drugs’ record against other viruses. She cites a “long history of having tried hydroxychloroquine as a treatment for emerging viral infections, and seeing it fail to help patients despite some activity in vitro and even in animal models.”
Impeding clinical trials
David Boulware, an infectious disease researcher at the University of Minnesota, Twin Cities, working on COVID-19 trials, suggests the EUA may impede testing of another potential COVID-19 treatment. He says colleagues working on a randomized, placebo-controlled, multisite trial of remdesivir, Gilead Sciences’s experimental antiviral drug, have encountered hospitalized COVID-19 patients who ask, “Do I want to get a placebo? I’m really sick and I can get hydroxychloroquine.” Some are opting out of the remdesivir study, Boulware says.
People say that the time to do these studies is not during a public health emergency—it’s too hard. Actually, that’s the best time, because with a crisis unfolding you have the greatest opportunity to learn about these products the quickest way, because of rapid enrollment.
Luciana Borio, former FDA acting chief scientist
Purposely or not, and despite skepticism from many doctors, FDA might have made hydroxychloroquine the de facto standard of care for COVID-19, he and others suggest. That could also undermine the COVID-19 trials of it and chloroquine. It’s too soon to know what the impact might be, researchers organizing those trials told ScienceInsider. But Peter Lurie, a physician and FDA executive under Obama and Trump who now heads the Center for Science in the Public Interest, a Washington, D.C., advocacy group, says the EUA weakens the incentive to sign up for a trial. “Why take a 50% chance of getting a placebo when you can be guaranteed to get a drug you’re hoping to get? Then you’re left in a situation where a drug is widely used and evidence of its effectiveness for this indication is never generated.”
With so many people dying from COVID-19, calling for more data before widespread use of the malaria drugs can be “a hard message,” Hamburg concedes. “People want to have a treatment available to them and their loved ones. But until [it’s] examined with some rigor, we won’t know whether this will work now, and it’s also making it hard to get answers for patients tomorrow and the future.”
Borio adds that proper trials need not take long. “People say that the time to do these studies is not during a public health emergency—it’s too hard. Actually, that’s the best time, because with a crisis unfolding you have the greatest opportunity to learn about these products the quickest way, because of rapid enrollment,” she says. “If it’s a blockbuster, we would know so quickly.”
FDA declined to comment specifically about trial enrollment concerns but said it is working with other federal agencies to plan clinical trials of the two drugs.
Risks rise when millions use a drug
Some FDA observers defend the agency by pointing out it has occasionally given full commercial approval to drugs based on relatively scant evidence, including a controversial treatment for Duchenne muscular dystrophy last year. Erika Lietzan of the University of Missouri School of Law, who studies food and drug regulation, cited Ceprotin—a biologic to treat patients with a genetically linked, life-threatening blood clotting problem—approved by FDA in 2007 based on a nonrandomized trial of only 18 subjects.
But the rare diseases addressed by those FDA actions affect few people compared with COVID-19. When FDA endorses a drug with known, life-threatening side effects for use by millions of hospitalized people to treat a poorly understood condition, the potential for harm rises exponentially, Lurie and others warn.
“What is quite certain: When you get large numbers of people exposed to [hydroxychloroquine], there will be important adverse effects,” including sometimes-lethal cardiac toxicity, Lurie says. “That can be acceptable in the setting of known benefits, but it’s more difficult to accept when there isn’t now and might never be evidence of benefit.”
“The idea that we have nothing to lose by trying anything with the smallest glimmer of hope is terribly misguided,” adds Patricia Zettler, a law professor at Ohio State University, Columbus, and former FDA associate chief counsel under Obama. “As a society, we risk losing the opportunity to understand what actually works, and what doesn’t.”
Another safety concern emerged on 20 March, when FDA lifted its import restrictions on Ipca Laboratories, a leading Indian maker of the drugs. FDA has repeatedly cited the company for manufacturing lapses, most recently in a scathing inspection report in August 2019. The agency told ScienceInsider the reprieve was only for the malaria drugs, to meet surging U.S. demand. It said the firm “agreed to perform additional quality mitigation steps” for the drugs.
“Ipca had data integrity issues and cascading failures in quality control,” says Hamburg, who led FDA when the firm was cited for such problems in 2014. “That signals to me that it’s probably not a drug we want from that supplier.”
Dangerous precedent?
FDA watchers also wonder how the agency will respond to the next remedy supported by anecdotal reports when facing public fears about a growing death toll and presidential pressure. There is no shortage of candidates—including zinc, remdesivir, the Japanese flu drug favipiravir (branded as Avigan), and a stem cell product touted by Trump attorney Rudy Giuliani. FDA said that by law, it “generally cannot confirm, deny, or comment” about such prospects, and “will not speculate” on future EUAs; it has, however, already approved the testing of the stem cell product in a clinical trial of COVID-19 patients.
“When the evidence base for granting the EUA is as flimsy as this, the question becomes, ‘Whose EUA will not be granted, especially in the context of an epidemic?’” Lurie says. “What happens when the epidemic is not [historically] bad, when it’s just a bad season of the flu?”
And Hamburg says she fears that with its EUA, FDA has taken “a step away from scientific rigor, to a system that is much more subject to all kinds of interference, from wishful thinking to frank political and economic motivations.”
doi:10.1126/science.abc1337
Charles Piller is a contributing correspondent based in Oakland, California.
‘This is insane!’ Many scientists lament Trump’s embrace of risky malaria drugs for coronavirus
A Chinese pharmaceutical company employee checks the creation of chloroquine phosphate, an old malaria treatment being touted for COVID-19; the company resumed its production last month after a 15-year break. FEATURE CHINA VIA AP IMAGES
By Charles Piller Mar. 26, 2020
When President Donald Trump recently touted the common malaria treatments hydroxychloroquine and chloroquine as potential remedies for coronavirus disease 2019 (COVID-19), he ignited unprecedented demand for the drugs—and set scientists’ teeth on edge. Although the World Health Organization (WHO) agrees the compounds are worth testing more fully on the pandemic coronavirus, few drug or infectious disease experts—not even the president’s own advisers—share his optimism that the drugs could become “one of the biggest game changers in the history of medicine,” as he tweeted. And many are critical of the small French clinical study of just 42 patients that seems to have touched off most of the excitement.
“The president was talking about hope,” Anthony Fauci, director of National Institute of Allergy and Infectious Diseases, said diplomatically at one of the White House briefings where Trump praised the drugs’ potential.
thers are less diplomatic. Darren Dahly, a co-author of one of several critiques of the initial study and a principal statistician at the University College Cork School of Public Health, said it would be “egregious” to recommend treatments for millions of people based on such a small trial, regardless of its quality. “This is insane!” tweeted Gaetan Burgio, an Australian National University expert on drug resistance, noting what he sees as lapses in the 6-day trial, including inconsistent testing of virus levels in the patients.
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To Dahly and others, only much larger, better studies such as one WHO has just started can show whether any optimism about the compounds is warranted. “The best way to know whether a medication for COVID-19 is effective is through a high-quality clinical trial,” says Joshua Sharfstein, a vice dean at Johns Hopkins University’s Bloomberg School of Public Health and a former principal deputy Food and Drug Administration commissioner. “Efforts to widely distribute unproven treatments are misguided at best and dangerous at worst.”
Such cautions were buried under an avalanche of demand for hydroxychloroquine, also sold under the brand name Plaquenil, and chloroquine, as doctors rushed to prescribe one or the other for confirmed or possible COVID-19 infections. Among the immediate consequences:
Shortages of the drug are endangering patients who need it for lupus or rheumatoid arthritis.
India, a major producer, has banned exports, and some doctors are hoarding both drugs by writing prescriptions for themselves or family members.
Deaths in Nigeria among people self-treating for apparent COVID-19 were attributed to chloroquine overdoses, and an Arizona man trying to avoid COVID-19 infection died after reportedly self-medicating with a toxic form of chloroquine used to clean fish tanks.
Brazilian President Jair Bolsonaro, a staunch Trump ally, ordered that nation’s military labs to ramp up production of chloroquine. Panic buying has ensued.
“Here in Brazil even good scientists are backing this, saying we should waive rigor in difficult times,” says Natalia Pasternak Taschner, a microbiologist at the University of São Paulo, São Paulo. “We should be even more rigorous lest we give people false hope and invest [limited] time and money on unwarranted claims.”
Although doctors regard hydroxychloroquine as relatively safe at prescribed doses for short periods, it has been associated with life-threatening cardiac side effects and suicidal behavior. “Given the toxicity of the drug, I’m afraid my government is going to kill people,” Taschner said.
Trump’s initial public remarks on the drug candidates at a 19 March briefing appeared to be based on anecdotal reports from China and the tiny French study, which Vanity Fair reports he learned of after Elon Musk tweeted about it and Fox News amplified the information. In that trial, the Mediterranean Infection University Hospital Institute (IHU) treated 26 COVID-19 patients with hydroxychloroquine alone, or combined with the antibiotic azithromycin. The authors reported “clearance”—no virus present in samples taken by nasopharyngeal swabs—in most of them, but continued infection in most of a 16-person control group of COVID-19 patients. The patients who received both drugs cleared the fastest, the researchers reported in a peer-reviewed paper in the International Journal of Antimicrobial Agents.
HYDROXYCHLOROQUINE & AZITHROMYCIN, taken together, have a real chance to
be one of the biggest game changers in the history of medicine. The FDA has moved mountains - Thank You! Hopefully they will BOTH (H works better with A, International Journal of Antimicrobial Agents).....
— Donald J. Trump (@realDonaldTrump) March 21, 2020
Many scientists have criticized the French trial as riddled with enough methodological flaws to render its findings unreliable or misleading. Biostatisticians from the United Kingdom and Ireland cited a basic failure: Investigators didn’t randomize the groups—essential to ensuring dependable comparisons. They also noted that six of the treated patients were lost to the study, five of whom fared badly—one died, three entered intensive care, and one stopped treatment because of nausea. Yet they were dropped from the analysis, potentially skewing the outcome.
Elisabeth Bik, a scientific integrity consultant, wrote on her blog that for some patients supposedly helped by the treatments, daily tests for the presence of the coronavirus fluctuated between positive and negative, suggesting the virus might have persisted, just below the test’s detection threshold. Investigators should have confirmed viral clearance over two or three consecutive days, she said, particularly because the trial did not keep track of clinical indicators such as fever or shortness of breath. But the viral tests also ended after no more than 6 days total for all patients.
Bik and other researchers have raised questions about other aspects of the paper, including its peer review, noting the submission and acceptance dates suggest it was reviewed in less than 24 hours. One of the paper’s authors is also the journal’s editor-in-chief, which Bik says might be “perceived as a huge conflict of interest.”
“Let’s put our work into running some proper trials, and see if this effect holds up in well-conducted studies,” Dahly says.
One of the French study authors, Didier Raoult, a prominent researcher who heads IHU, released a statement on Monday in response to the criticisms. He said he would treat any COVID-19 patient with a combination of hydroxychloroquine and azithromycin immediately after diagnosis. (“Like any doctor, once a treatment has been shown to be effective, I find it immoral not to administer it. It’s as simple as that,” he told the French newspaper Libération.)
A clearer verdict may come from the WHO megatrial and two other major trials of hydroxychloroquine in different doses that have started at Columbia University and the University of Minnesota. New York Governor Andrew Cuomo announced that the state also will fast-track a trial of hydroxychloroquine plus azithromycin.
Yet evidence from pending studies will certainly lag massive off-label use of chloroquine and hydroxychloroquine given the presidential endorsement. Several major pharma companies announced production of nearly 200 million doses of the two drugs in coming weeks to fight the pandemic.
Vinay Prasad, a hematologist and oncologist at Oregon Health & Science University who studies evidence-based medicine, calls the rush to use the drugs unwise. “In times of epidemic, you want to prioritize manufacturing things that have been proven to work,” many of which are in short supply, he says. “Masks, gowns, ventilators. Have at it. Before ramping up the supply of pills, it’s best to know if the pills work.”
doi:10.1126/science.abb9021
LETTERS
Disinfection threatens aquatic ecosystems
Disinfectants used to combat the spread of COVID-19 will end up in the environment.
Hong Zhang1,4,*,
Wenzhong Tang1,4,
Yushun Chen2,4,
Wei Yin3
See all authors and affiliations
Science 10 Apr 2020:
Vol. 368, Issue 6487, pp. 146-147
DOI: 10.1126/science.abb8905
Article
PDF
PHOTO: NARAYAN MAHARJAN/NURPHOTO/GETTY IMAGES
In an effort to contain the spread of coronavirus disease 2019 (COVID-19), China has been applying chlorine disinfectants to both indoor and outdoor spaces. To minimize opportunities for the severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2)—the virus that causes COVID-19—to thrive, China has dispensed more than 5000 tons of disinfectants in Wuhan City alone (1). These chemicals can get into sewage systems and pollute drinking water resources (1). Both the direct runoff and indirect sewage effluents will eventually end up in lakes and rivers, putting aquatic ecosystems at risk (2).
Chlorine disinfectants threaten aquatic plants and wildlife in two ways.
Disinfection threatens aquatic ecosystems
Disinfectants used to combat the spread of COVID-19 will end up in the environment.
Hong Zhang1,4,*,
Wenzhong Tang1,4,
Yushun Chen2,4,
Wei Yin3
See all authors and affiliations
Science 10 Apr 2020:
Vol. 368, Issue 6487, pp. 146-147
DOI: 10.1126/science.abb8905
Article
PHOTO: NARAYAN MAHARJAN/NURPHOTO/GETTY IMAGES
In an effort to contain the spread of coronavirus disease 2019 (COVID-19), China has been applying chlorine disinfectants to both indoor and outdoor spaces. To minimize opportunities for the severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2)—the virus that causes COVID-19—to thrive, China has dispensed more than 5000 tons of disinfectants in Wuhan City alone (1). These chemicals can get into sewage systems and pollute drinking water resources (1). Both the direct runoff and indirect sewage effluents will eventually end up in lakes and rivers, putting aquatic ecosystems at risk (2).
Chlorine disinfectants threaten aquatic plants and wildlife in two ways.
First, chlorine can directly harm organisms by destroying their cell walls or damaging their proteins by oxidation (2). Second, the chemicals in the disinfectants can bond with other materials to form harmful compounds. In surface water, dissolved organic matter is extremely high (3), which could allow the synthesis of disinfection by-products, such as trihalomethanes or haloacetic acids (2). These by-products have been shown to be very toxic to aquatic organisms (4). In addition, disinfectants could combine with nitrogen, forming chloramine or N-nitrosodimethylamine (5), both of which have been identified as carcinogens (6).
As COVID-19 spreads across the globe, the increased use of disinfectants could lead to worldwide secondary disasters in aquatic ecosystems. We appeal to the governments of China and other affected countries to conduct aquatic ecological integrity assessments (7) during and after the pandemic. This could save biodiversity and protect humans from future health threats stemming from polluted water.
http://www.sciencemag.org/about/science-licenses-journal-article-reuse
This is an article distributed under the terms of the Science Journals Default License.
References and Notes
China Ministry of Ecology and Environment, “Will viruses and disinfection affect water quality?
As COVID-19 spreads across the globe, the increased use of disinfectants could lead to worldwide secondary disasters in aquatic ecosystems. We appeal to the governments of China and other affected countries to conduct aquatic ecological integrity assessments (7) during and after the pandemic. This could save biodiversity and protect humans from future health threats stemming from polluted water.
http://www.sciencemag.org/about/science-licenses-journal-article-reuse
This is an article distributed under the terms of the Science Journals Default License.
References and Notes
China Ministry of Ecology and Environment, “Will viruses and disinfection affect water quality?
The Ministry of Ecology and Environment responded” (2020);www.mee.gov.cn/ywgz/ssthjbh/dbssthjgl/202003/t20200311_768408.shtml [in Chinese].
D. L. Sedlak, U. von Gunten , Science 331, 42 (2011).
J. A. Leenheer , in Environmental Chemistry of Lakes and Reservoirs, L. A. Baker, Ed. (American Chemical Society, 1994), pp. 195–221.
J. Liu, X. Zhang , Water Res. 65, 64 (2014).
E. Bei et al ., Water Res. 98, 168 (2016).
S. Krytopoulos , Br. J. Cancer 40, 666 (1979).
J. R. Karr , Environ. Toxicol. Chem. 12, 1521 (1993).
D. L. Sedlak, U. von Gunten , Science 331, 42 (2011).
J. A. Leenheer , in Environmental Chemistry of Lakes and Reservoirs, L. A. Baker, Ed. (American Chemical Society, 1994), pp. 195–221.
J. Liu, X. Zhang , Water Res. 65, 64 (2014).
E. Bei et al ., Water Res. 98, 168 (2016).
S. Krytopoulos , Br. J. Cancer 40, 666 (1979).
J. R. Karr , Environ. Toxicol. Chem. 12, 1521 (1993).
Opinion: Why carbon pricing is not sufficient to mitigate climate change—and how “sustainability transition policy” can help
Daniel Rosenbloom, Jochen Markard, Frank W. Geels, and Lea Fuenfschilling
PNAS first published April 8, 2020 https://doi.org/10.1073/pnas.2004093117
PDF
Carbon pricing is often presented as the primary policy approach to address climate change. We challenge this position and offer “sustainability transition policy” (STP) as an alternative. Carbon pricing has weaknesses with regard to five central dimensions: 1) problem framing and solution orientation, 2) policy priorities, 3) innovation approach, 4) contextual considerations, and 5) politics. In order to address the urgency of climate change and to achieve deep decarbonization, climate policy responses need to move beyond market failure reasoning and focus on fundamental changes in existing sociotechnical systems such as energy, mobility, food, and industrial production. The core principles of STP can help tackle this challenge.
Carbon Pricing Critique
Realizing deep decarbonization at the pace necessary to mitigate the worst impacts of climate change has emerged as a pressing challenge for policymakers (1). As a result, the debate about appropriate policy responses has intensified. Many experts and societal actors see carbon pricing as the primary way forward (2⇓–4). Some even use it to argue against other policies, such as fuel efficiency standards. Viewed as the most efficient approach to cut greenhouse gas (GHG) emissions, carbon pricing incentivizes actors to seek the lowest-cost abatement options for their specific circumstances. Consequently, many economists argue that carbon pricing should be the cornerstone of a climate policy response.
We question this reasoning. Carbon pricing faces five major issues that limit its use for accelerating deep decarbonization. First, carbon pricing frames climate change as a market failure rather than as a fundamental system problem. Second, it places particular weight on efficiency as opposed to effectiveness. Third, it tends to stimulate the optimization of existing systems rather than transformation. Fourth, it suggests a universal instead of context-sensitive policy approach. Fifth, it fails to reflect political realities.
Given these limitations, we propose an alternative approach that targets fundamental transformations of existing sociotechnical systems, such as energy, mobility, or food (i.e., “sustainability transitions”) (5). STP entails a mix of contextually and politically sensitive policies that simultaneously drive low-carbon innovation and the decline of fossil fuels.
Market Failure versus System Problem
The underlying rationale for carbon pricing is appealing in its simplicity: GHG emissions are viewed as a negative externality because the social costs flowing from climate change impacts are not reflected in the market price of carbon-intensive goods and services (6). Climate change is framed as the consequence of a market failure that can be corrected by placing a price on carbon so that actors also pay for the social cost of their carbon-intensive activities and reduce their demand for such goods and services.
Framing the climate challenge as a market failure, however, fails to seriously appreciate its scope and depth. Indeed, the climate challenge has been referred to as a “grand challenge” (7) or “super wicked problem” (8) that has thus far resisted traditional policy approaches.
We argue that climate change can be more appropriately understood as a system problem. Core societal functions, such as heating or mobility, are met through large and deeply entrenched sociotechnical systems made up of interconnected technologies, infrastructures, regulations, business models, and lifestyles (1). Over many decades, these systems have become increasingly locked into the combustion of fossil fuels and the associated release of GHG emissions. Consider, for instance, how the design of cities has developed alongside the diffusion of the gasoline-powered personal automobile; how norms about comfort and attire have become entwined with energy-intensive indoor temperature regulation; and how important political and economic interests have become entrenched with fossil fuel-based resource development or electricity provision.
Addressing the climate challenge, therefore, involves fundamental changes to existing systems, referred to as “sustainability transitions” (5). These transitions entail profound and interdependent adjustments in sociotechnical systems that cannot be reduced to a single driver, such as shifts in relative market prices. In mobility, for example, a low-carbon transition might encompass interacting developments around new vehicle technologies (e.g., autonomous electric cars), infrastructures (e.g., vehicle charging stations and high-speed rail), business models (e.g., mobility as a service and intermodal transport), and regulation (e.g., emission performance standards) but also changes in city planning (e.g., reduced urban sprawl) and lifestyles (e.g., telework and local vacations). The market failure framing fails to appreciate the broad scope of the climate challenge and the sweep of system elements that must undergo change. And so, the resulting solution orientation is far from sufficient.
Efficiency versus Effectiveness
Carbon pricing strategies are often considered to be the most efficient means of reducing carbon emissions (4, 6). They do so by affording heterogeneous polluters (e.g., firms from different industries) the flexibility of responding to the carbon price signal in a least-cost fashion, selecting the level of abatement and specific abatement options that are most cost-effective for their circumstances. Abatement options are then adopted in a stepwise manner in line with the carbon price. Under a series of assumptions (e.g., economic rationality, perfect information, credibility, and broad coverage), the result is that “a given level of abatement is met at least global cost” which “no other instrument than pricing is able to realize” (2).
A transparent price signal is often considered to be a core benefit of carbon pricing strategies, as it conveys information about the external costs of greenhouse gases to consumers and firms, allowing them to internalize these costs in their decision-making (6). Market forces, in this view, act as the principal drivers of change. The primary role of government is to “set the right price” and “leave the rest to the market.” This, however, fails to acknowledge the substantial contestation around climate policy and the political nature of markets.
Carbon pricing strategies are not politically neutral but normative endeavors (i.e., centered on what constitutes appropriate solutions and why) with major distributional consequences (i.e., who will win or lose). As with the majority of climate policies, they threaten the endowments of incumbent firms and industries. Many of these actors have responded by using their considerable influence to resist and weaken the stringency of carbon pricing measures, such as the European Union’s Emissions Trading System (23). Carbon pricing has also attracted political resistance among the broader public, as it is perceived to challenge longstanding practices and livelihoods, such as car-based and suburban lifestyles. Political opponents have been quick to exploit these cleavages around carbon pricing, leading to important electoral victories and climate policy reversals in Canada, France, Australia, and many other jurisdictions (24). While some advocates propose revenue recycling from carbon pricing to encourage public acceptance (3), far more is needed to appreciate the “irreducibly political character” of climate policy (25).
In this way, we argue for more explicit engagement with the politics of climate policy. While politics tends to be regarded as a barrier to climate action, research suggests that well-designed climate policies can also generate self-reinforcing political dynamics that can set in motion transformative processes (26⇓–28). Sequences of policies designed to strengthen supportive coalitions with an interest in low-carbon alternatives (e.g., networks of innovators, communities, and civil society actors) may create conditions for political victories and more ambitious climate policies over subsequent rounds of political debate and policymaking (27).
Sustainability Transition Policy (STP)
Given the limitations of a climate response based on carbon pricing strategies, we offer “sustainability transition policy” (STP) as an alternative (Table 1). Framing the climate challenge as a system problem, STP emphasizes the rapid and effective reduction of emissions, system transformation and radical innovation, the development of context-sensitive responses, and the inherent political nature of decarbonization.
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Table 1. Comparison of carbon pricing strategies and sustainability transition policy
Indeed, STP is predicated on the notion that a low-carbon transition will involve multiple and co-evolving social and technological changes. Many levers will need to be pulled and deliberately aligned to realize change—from supporting emerging innovations and decommissioning existing technologies or infrastructure, to building coalitions of actors and interests, to (re)designing market rules and planning processes, to legitimizing new practices and related social norms. Carbon pricing can be part of this policy mix, but should not be seen as the single best or primary instrument.
Embracing these varied levers, STP is not about a single policy intervention but a coherent sequence of policy decisions—and associated changes in technologies, business models, and practices—that together drive potential decarbonization pathways for sociotechnical systems under conditions of complexity and uncertainty (29). Broadly, STP targets innovation and decline (30). That is, it includes policies to support low-carbon innovations and their upscaling, as well as policies to exert pressure on carbon-intensive products, technologies, and practices to eventually stimulate their decline (Fig. 1). Innovation is important to continually develop alternatives. Decline is crucial to break up lock-ins and to signal to producers and consumers that fundamental changes are necessary.
Fig. 1.
To achieve a low carbon future, we need not only policies that encourage innovations such as solar photovoltaics, but policies that discourage carbon-intensive technologies, such as coal. And those policies should enlist a variety of instruments that adapt over time.
STP also acknowledges that transitions develop through different phases, from early takeoff to later acceleration and consolidation (31, 32). Early-stage innovations, for example, need experimentation in protected spaces (i.e., niches, which shield their development from harsh competitive pressures) (33). Accelerating low-carbon innovation requires diffusion and deployment policies that aim at embedding and scaling niche experiments beyond their initial boundaries, targeting, for example, the creation of new networks, entrepreneurial activities, and standards, as well as education and training.
There is a similar phase-logic with respect to decline. Destabilization and weakening lock-in mechanisms can create windows of opportunity for new practices, business models, and technologies (34). Policy instruments for destabilization include divestment strategies, removal of fossil fuel subsidies, carbon pricing, or stronger environmental standards. To accelerate decline, policy also has a role to play in implementing phaseouts. Otherwise, problematic technologies can persist for decades. Phase-out policies have, for instance, targeted incandescent light bulbs, coal-fired power, and nuclear power.
STP also appreciates the central place of policy and politics. Climate or transition policies are layered on top of existing institutional frameworks, which means that policy formulation and implementation is a complex, messy, and often piecemeal process that resists optimal solutions. And, in the face of political conflict and resistance, it is crucial to generate societal and business support for climate policy responses. This is why stimulating low-carbon innovations and associated supportive coalitions with a material interest in these innovations is of critical importance. Over subsequent cycles of policymaking, climate policies, low-carbon innovations, and supportive coalitions can mutually reinforce one another to drive low-carbon pathways. In general, STP calls for new modes of governance that are better-suited to the context of transformative change. Such an approach recognizes the importance of continually adapting specific measures in response to new developments and learning but also acknowledges that the overarching directionality of policy (commitments, resources, etc.) should be stabilized in order to drive a transition (28).
In summary, the dominant logic of contemporary climate policy, in which carbon pricing is the central policy response, is deeply flawed. Given the aforementioned shortcomings, carbon pricing should not be the primary policy strategy to combat climate change. Instead, carbon pricing should be used as part of a policy mix that promotes innovation and decline, accounts for political dynamics, varies between sectors and over time, and aims at profound system change.
References
F. W. Geels, B. K. Sovacool, T. Schwanen, S. Sorrell, Sociotechnical transitions for deep decarbonization. Science 357, 1242–1244 (2017).
D. Rosenbloom, Pathways: An emerging concept for the theory and governance of low-carbon transitions. Glob. Environ. Change 43, 37–50 (2017).
P. Kivimaa, F. Kern, Creative destruction or mere niche support? Innovation policy mixes for sustainability transitions. Res. Policy 45, 205–217 (2016).
D. Loorbach, N. Frantzeskaki, F. Avelino, Sustainability transitions research: Transforming science and practice for societal change. Annu. Rev. Environ. Resour. 42, 599–626 (2017).
J. Markard, The next phase of the energy transition and its implications for research and policy. Nat. Energy 3, 628–633 (2018).
A. Smith, R. Raven, What is protective space? Reconsidering niches in transitions to sustainability. Res. Policy 41, 1025–1036 (2012).
B. Turnheim, F. W. Geels, Regime destabilisation as the flipside of energy transitions: Lessons from the history of the British coal industry (1913–1997). Energy Policy 50, 35–49 (2012).
Daniel Rosenbloom, Jochen Markard, Frank W. Geels, and Lea Fuenfschilling
PNAS first published April 8, 2020 https://doi.org/10.1073/pnas.2004093117
Carbon pricing is often presented as the primary policy approach to address climate change. We challenge this position and offer “sustainability transition policy” (STP) as an alternative. Carbon pricing has weaknesses with regard to five central dimensions: 1) problem framing and solution orientation, 2) policy priorities, 3) innovation approach, 4) contextual considerations, and 5) politics. In order to address the urgency of climate change and to achieve deep decarbonization, climate policy responses need to move beyond market failure reasoning and focus on fundamental changes in existing sociotechnical systems such as energy, mobility, food, and industrial production. The core principles of STP can help tackle this challenge.
Carbon Pricing Critique
Realizing deep decarbonization at the pace necessary to mitigate the worst impacts of climate change has emerged as a pressing challenge for policymakers (1). As a result, the debate about appropriate policy responses has intensified. Many experts and societal actors see carbon pricing as the primary way forward (2⇓–4). Some even use it to argue against other policies, such as fuel efficiency standards. Viewed as the most efficient approach to cut greenhouse gas (GHG) emissions, carbon pricing incentivizes actors to seek the lowest-cost abatement options for their specific circumstances. Consequently, many economists argue that carbon pricing should be the cornerstone of a climate policy response.
We question this reasoning. Carbon pricing faces five major issues that limit its use for accelerating deep decarbonization. First, carbon pricing frames climate change as a market failure rather than as a fundamental system problem. Second, it places particular weight on efficiency as opposed to effectiveness. Third, it tends to stimulate the optimization of existing systems rather than transformation. Fourth, it suggests a universal instead of context-sensitive policy approach. Fifth, it fails to reflect political realities.
Given these limitations, we propose an alternative approach that targets fundamental transformations of existing sociotechnical systems, such as energy, mobility, or food (i.e., “sustainability transitions”) (5). STP entails a mix of contextually and politically sensitive policies that simultaneously drive low-carbon innovation and the decline of fossil fuels.
Market Failure versus System Problem
The underlying rationale for carbon pricing is appealing in its simplicity: GHG emissions are viewed as a negative externality because the social costs flowing from climate change impacts are not reflected in the market price of carbon-intensive goods and services (6). Climate change is framed as the consequence of a market failure that can be corrected by placing a price on carbon so that actors also pay for the social cost of their carbon-intensive activities and reduce their demand for such goods and services.
Framing the climate challenge as a market failure, however, fails to seriously appreciate its scope and depth. Indeed, the climate challenge has been referred to as a “grand challenge” (7) or “super wicked problem” (8) that has thus far resisted traditional policy approaches.
We argue that climate change can be more appropriately understood as a system problem. Core societal functions, such as heating or mobility, are met through large and deeply entrenched sociotechnical systems made up of interconnected technologies, infrastructures, regulations, business models, and lifestyles (1). Over many decades, these systems have become increasingly locked into the combustion of fossil fuels and the associated release of GHG emissions. Consider, for instance, how the design of cities has developed alongside the diffusion of the gasoline-powered personal automobile; how norms about comfort and attire have become entwined with energy-intensive indoor temperature regulation; and how important political and economic interests have become entrenched with fossil fuel-based resource development or electricity provision.
Addressing the climate challenge, therefore, involves fundamental changes to existing systems, referred to as “sustainability transitions” (5). These transitions entail profound and interdependent adjustments in sociotechnical systems that cannot be reduced to a single driver, such as shifts in relative market prices. In mobility, for example, a low-carbon transition might encompass interacting developments around new vehicle technologies (e.g., autonomous electric cars), infrastructures (e.g., vehicle charging stations and high-speed rail), business models (e.g., mobility as a service and intermodal transport), and regulation (e.g., emission performance standards) but also changes in city planning (e.g., reduced urban sprawl) and lifestyles (e.g., telework and local vacations). The market failure framing fails to appreciate the broad scope of the climate challenge and the sweep of system elements that must undergo change. And so, the resulting solution orientation is far from sufficient.
Efficiency versus Effectiveness
Carbon pricing strategies are often considered to be the most efficient means of reducing carbon emissions (4, 6). They do so by affording heterogeneous polluters (e.g., firms from different industries) the flexibility of responding to the carbon price signal in a least-cost fashion, selecting the level of abatement and specific abatement options that are most cost-effective for their circumstances. Abatement options are then adopted in a stepwise manner in line with the carbon price. Under a series of assumptions (e.g., economic rationality, perfect information, credibility, and broad coverage), the result is that “a given level of abatement is met at least global cost” which “no other instrument than pricing is able to realize” (2).
We question whether efficiency should be an overriding priority of climate policy. If we are to limit global warming to less than 1.5 °C, there is little time remaining to reach carbon neutrality (9). The negative impacts of climate change are already undermining human prosperity and the cost of inaction will escalate the longer we wait (10). Despite the urgency of the problem, carbon pricing places considerable weight on seeking low-hanging fruit and, according to Patt and Lilliestam, fails to appreciate that “we must eventually pick all of the apples on the tree” (11). Furthermore, as of 2019, existing carbon pricing schemes only cover about 20% of global emissions and more than two-thirds of these have prices below $20 United States dollars (USD) per ton of CO2 equivalent.* This is far too low to be effective and increasing coverage and prices presents serious challenges, which we return to below.
Efficiency considerations must, therefore, be tempered by an immediate need to realize carbon neutrality through whatever means actually work. This implies moving beyond lowest-cost solutions to stimulate a diversity of mitigation options, including those that have considerable immediate reduction potential (e.g., phasing out coal or restoring peatlands) and others that may fundamentally transform systems in the longer term (e.g., mobility-as-a-service or biobased materials).
Optimizing versus Transforming
By increasing the relative price of carbon-intensive goods and services, carbon pricing is understood to incentivize the adoption of existing low-carbon technologies and (indirectly) stimulate the development of low-carbon innovations (2). Investments in low-carbon alternatives are not only encouraged through present carbon prices but also through expectations about future carbon price increases.
It is, however, unclear how strong such innovation effects actually are and whether carbon pricing can generate more than incremental changes. Tvinnereim and Mehling (12), for instance, review the record of several prominent carbon pricing strategies and find that they have, to date, helped realize limited opportunities for innovation and system-wide transformation. Rather, current trajectories and emission reductions deviate little from business-as-usual scenarios, even in the case of Sweden’s $140 (USD) carbon price for the transport and building sectors. Others have observed similar patterns (13⇓–15). This suggests that, in practice, carbon pricing strategies tend to promote the optimization of established business models and technologies but neglect more fundamental system change necessary for deep decarbonization.
While optimization remains important, it does little to confront carbon lock-in, encourage radical innovation, or avoid dead-end paths (16). Indeed, research indicates that investments in long-lived, carbon-intensive infrastructures, such as natural gas, are still ongoing, even in jurisdictions with prominent carbon pricing regimes (12, 17). Retiring these investments prematurely in order to align with deep decarbonization pathways will be politically difficult and costly (i.e., due to compensation for affected firms and communities).
In contrast, we argue that incremental change alone is insufficient to pursue low-carbon pathways at the required pace. Established systems are characterized by deep lock-ins (e.g., large sunk costs in infrastructure and cultural conventions underpinning user practices) that encourage movement along established development trajectories (18, 19). Deliberately accelerating transitions, therefore, involves weakening lock-ins (e.g., removing fossil fuel subsidies and banning carbon-intensive technologies) and supporting system building for low-carbon alternatives (e.g., stimulating new innovations, business models, and markets).
Universal versus Context Sensitive Policy
Carbon pricing strategies tend to be predicated on the notion that, eventually, all emissions are covered so that all prices will be corrected such that no economic decision would escape carbon pricing’s regulatory impact (2). This means that all jurisdictions and economic sectors should be included, ideally with uniform price signals (6). In the absence of uniform pricing, there is a risk that some nations will free-ride on the efforts of others and that firms will relocate to places with lower or no carbon prices (i.e., “carbon leakage”).
Three issues confront this universal approach. First, the required levels of coordination and cooperation are unrealistic, as carbon pricing encounters a fragmented international climate policy landscape (20). In the absence of a global sovereign and considering the great diversity of national circumstances (where countries have different responsibilities for generating the problem, vulnerabilities, and resources to adapt and support mitigation), cooperation or convergence among emission pricing frameworks remain elusive. Second, a universal approach will require well-functioning institutional structures and high levels of regulatory competences and monitoring systems, which do not exist everywhere. Third, carbon pricing strategies tend to ignore that policies need to be tailored to local and/or sectoral contexts in order to address specific sources of lock-in and opportunities for innovation.
Carbon pricing functions well in sectors, such as electricity, with large, fixed-point sources, where alternative technologies are available and polluters cannot easily relocate; it’s more difficult to implement in agro-food, transport, and heavy industry (14). Agro-food systems are characterized by manifold commodities, dispersed production (millions of farmers) in highly variable contexts (soil conditions, climate, local communities), and deeply entrenched cultural conventions, such as tastes and dietary habits (21), which all make it extremely difficult to assess the level of an effective carbon price and implement this throughout the system. Existing and proposed carbon prices also face problems in transport, often translating into pennies on the gallon. Such effects fall short of inducing the needed lifestyle changes or even being distinguished from standard oil market fluctuations.
This highlights the major difference between systems across different sectors, scales, and locations. The geophysical resources, infrastructures, actor networks, and availability of low-carbon alternatives diverge markedly from one system to another. Thus, the specific package of policy solutions (e.g., performance standards versus technology mandates) will also vary accordingly. And, given the above-mentioned challenges facing a uniform global response, climate policy will be defined by layered and interacting efforts within and across different contexts (22).
Many are eager to take more substantive policy steps to address climate change, but pricing carbon pricing alone won’t be sufficient. Image credit: Shutterstock/Shawn Goldberg.
Political Realities
Efficiency considerations must, therefore, be tempered by an immediate need to realize carbon neutrality through whatever means actually work. This implies moving beyond lowest-cost solutions to stimulate a diversity of mitigation options, including those that have considerable immediate reduction potential (e.g., phasing out coal or restoring peatlands) and others that may fundamentally transform systems in the longer term (e.g., mobility-as-a-service or biobased materials).
Optimizing versus Transforming
By increasing the relative price of carbon-intensive goods and services, carbon pricing is understood to incentivize the adoption of existing low-carbon technologies and (indirectly) stimulate the development of low-carbon innovations (2). Investments in low-carbon alternatives are not only encouraged through present carbon prices but also through expectations about future carbon price increases.
It is, however, unclear how strong such innovation effects actually are and whether carbon pricing can generate more than incremental changes. Tvinnereim and Mehling (12), for instance, review the record of several prominent carbon pricing strategies and find that they have, to date, helped realize limited opportunities for innovation and system-wide transformation. Rather, current trajectories and emission reductions deviate little from business-as-usual scenarios, even in the case of Sweden’s $140 (USD) carbon price for the transport and building sectors. Others have observed similar patterns (13⇓–15). This suggests that, in practice, carbon pricing strategies tend to promote the optimization of established business models and technologies but neglect more fundamental system change necessary for deep decarbonization.
While optimization remains important, it does little to confront carbon lock-in, encourage radical innovation, or avoid dead-end paths (16). Indeed, research indicates that investments in long-lived, carbon-intensive infrastructures, such as natural gas, are still ongoing, even in jurisdictions with prominent carbon pricing regimes (12, 17). Retiring these investments prematurely in order to align with deep decarbonization pathways will be politically difficult and costly (i.e., due to compensation for affected firms and communities).
In contrast, we argue that incremental change alone is insufficient to pursue low-carbon pathways at the required pace. Established systems are characterized by deep lock-ins (e.g., large sunk costs in infrastructure and cultural conventions underpinning user practices) that encourage movement along established development trajectories (18, 19). Deliberately accelerating transitions, therefore, involves weakening lock-ins (e.g., removing fossil fuel subsidies and banning carbon-intensive technologies) and supporting system building for low-carbon alternatives (e.g., stimulating new innovations, business models, and markets).
Universal versus Context Sensitive Policy
Carbon pricing strategies tend to be predicated on the notion that, eventually, all emissions are covered so that all prices will be corrected such that no economic decision would escape carbon pricing’s regulatory impact (2). This means that all jurisdictions and economic sectors should be included, ideally with uniform price signals (6). In the absence of uniform pricing, there is a risk that some nations will free-ride on the efforts of others and that firms will relocate to places with lower or no carbon prices (i.e., “carbon leakage”).
Three issues confront this universal approach. First, the required levels of coordination and cooperation are unrealistic, as carbon pricing encounters a fragmented international climate policy landscape (20). In the absence of a global sovereign and considering the great diversity of national circumstances (where countries have different responsibilities for generating the problem, vulnerabilities, and resources to adapt and support mitigation), cooperation or convergence among emission pricing frameworks remain elusive. Second, a universal approach will require well-functioning institutional structures and high levels of regulatory competences and monitoring systems, which do not exist everywhere. Third, carbon pricing strategies tend to ignore that policies need to be tailored to local and/or sectoral contexts in order to address specific sources of lock-in and opportunities for innovation.
Carbon pricing functions well in sectors, such as electricity, with large, fixed-point sources, where alternative technologies are available and polluters cannot easily relocate; it’s more difficult to implement in agro-food, transport, and heavy industry (14). Agro-food systems are characterized by manifold commodities, dispersed production (millions of farmers) in highly variable contexts (soil conditions, climate, local communities), and deeply entrenched cultural conventions, such as tastes and dietary habits (21), which all make it extremely difficult to assess the level of an effective carbon price and implement this throughout the system. Existing and proposed carbon prices also face problems in transport, often translating into pennies on the gallon. Such effects fall short of inducing the needed lifestyle changes or even being distinguished from standard oil market fluctuations.
This highlights the major difference between systems across different sectors, scales, and locations. The geophysical resources, infrastructures, actor networks, and availability of low-carbon alternatives diverge markedly from one system to another. Thus, the specific package of policy solutions (e.g., performance standards versus technology mandates) will also vary accordingly. And, given the above-mentioned challenges facing a uniform global response, climate policy will be defined by layered and interacting efforts within and across different contexts (22).
Many are eager to take more substantive policy steps to address climate change, but pricing carbon pricing alone won’t be sufficient. Image credit: Shutterstock/Shawn Goldberg.
Political Realities
A transparent price signal is often considered to be a core benefit of carbon pricing strategies, as it conveys information about the external costs of greenhouse gases to consumers and firms, allowing them to internalize these costs in their decision-making (6). Market forces, in this view, act as the principal drivers of change. The primary role of government is to “set the right price” and “leave the rest to the market.” This, however, fails to acknowledge the substantial contestation around climate policy and the political nature of markets.
Carbon pricing strategies are not politically neutral but normative endeavors (i.e., centered on what constitutes appropriate solutions and why) with major distributional consequences (i.e., who will win or lose). As with the majority of climate policies, they threaten the endowments of incumbent firms and industries. Many of these actors have responded by using their considerable influence to resist and weaken the stringency of carbon pricing measures, such as the European Union’s Emissions Trading System (23). Carbon pricing has also attracted political resistance among the broader public, as it is perceived to challenge longstanding practices and livelihoods, such as car-based and suburban lifestyles. Political opponents have been quick to exploit these cleavages around carbon pricing, leading to important electoral victories and climate policy reversals in Canada, France, Australia, and many other jurisdictions (24). While some advocates propose revenue recycling from carbon pricing to encourage public acceptance (3), far more is needed to appreciate the “irreducibly political character” of climate policy (25).
In this way, we argue for more explicit engagement with the politics of climate policy. While politics tends to be regarded as a barrier to climate action, research suggests that well-designed climate policies can also generate self-reinforcing political dynamics that can set in motion transformative processes (26⇓–28). Sequences of policies designed to strengthen supportive coalitions with an interest in low-carbon alternatives (e.g., networks of innovators, communities, and civil society actors) may create conditions for political victories and more ambitious climate policies over subsequent rounds of political debate and policymaking (27).
Sustainability Transition Policy (STP)
Given the limitations of a climate response based on carbon pricing strategies, we offer “sustainability transition policy” (STP) as an alternative (Table 1). Framing the climate challenge as a system problem, STP emphasizes the rapid and effective reduction of emissions, system transformation and radical innovation, the development of context-sensitive responses, and the inherent political nature of decarbonization.
Table 1.
Comparison of carbon pricing strategies and sustainability transition policy
| Carbon pricing strategies | Sustainability transition policy | |
| Conceptual roots | Neoclassical economics | Innovation studies, evolutionary economics, institutional theory |
| Problem framing and solution orientation | Climate change as a market failure problem: price carbon to correct market signals | Climate change as a system problem: fundamentally transform existing sociotechnical systems |
| Overriding policy priority | Efficiency: reduce carbon emissions while keeping the economy wide costs at a minimum | Effectiveness: drive down emissions as quickly as possible |
| Innovation approach | Incremental change, indirect stimulation of innovation | Transformative change, direct stimulation of innovation |
| Contextual considerations | Universality: carbon pricing for all jurisdictions and sectors | Tailoring: policies should be adapted to local and sectoral contexts |
| Understanding of politics | Revenue recycling to deal with political realities | Creation of alternatives and formation of supportive coalitions |
VIEW POPUP
Table 1. Comparison of carbon pricing strategies and sustainability transition policy
Indeed, STP is predicated on the notion that a low-carbon transition will involve multiple and co-evolving social and technological changes. Many levers will need to be pulled and deliberately aligned to realize change—from supporting emerging innovations and decommissioning existing technologies or infrastructure, to building coalitions of actors and interests, to (re)designing market rules and planning processes, to legitimizing new practices and related social norms. Carbon pricing can be part of this policy mix, but should not be seen as the single best or primary instrument.
Embracing these varied levers, STP is not about a single policy intervention but a coherent sequence of policy decisions—and associated changes in technologies, business models, and practices—that together drive potential decarbonization pathways for sociotechnical systems under conditions of complexity and uncertainty (29). Broadly, STP targets innovation and decline (30). That is, it includes policies to support low-carbon innovations and their upscaling, as well as policies to exert pressure on carbon-intensive products, technologies, and practices to eventually stimulate their decline (Fig. 1). Innovation is important to continually develop alternatives. Decline is crucial to break up lock-ins and to signal to producers and consumers that fundamental changes are necessary.
Fig. 1.
To achieve a low carbon future, we need not only policies that encourage innovations such as solar photovoltaics, but policies that discourage carbon-intensive technologies, such as coal. And those policies should enlist a variety of instruments that adapt over time.
STP also acknowledges that transitions develop through different phases, from early takeoff to later acceleration and consolidation (31, 32). Early-stage innovations, for example, need experimentation in protected spaces (i.e., niches, which shield their development from harsh competitive pressures) (33). Accelerating low-carbon innovation requires diffusion and deployment policies that aim at embedding and scaling niche experiments beyond their initial boundaries, targeting, for example, the creation of new networks, entrepreneurial activities, and standards, as well as education and training.
There is a similar phase-logic with respect to decline. Destabilization and weakening lock-in mechanisms can create windows of opportunity for new practices, business models, and technologies (34). Policy instruments for destabilization include divestment strategies, removal of fossil fuel subsidies, carbon pricing, or stronger environmental standards. To accelerate decline, policy also has a role to play in implementing phaseouts. Otherwise, problematic technologies can persist for decades. Phase-out policies have, for instance, targeted incandescent light bulbs, coal-fired power, and nuclear power.
STP also appreciates the central place of policy and politics. Climate or transition policies are layered on top of existing institutional frameworks, which means that policy formulation and implementation is a complex, messy, and often piecemeal process that resists optimal solutions. And, in the face of political conflict and resistance, it is crucial to generate societal and business support for climate policy responses. This is why stimulating low-carbon innovations and associated supportive coalitions with a material interest in these innovations is of critical importance. Over subsequent cycles of policymaking, climate policies, low-carbon innovations, and supportive coalitions can mutually reinforce one another to drive low-carbon pathways. In general, STP calls for new modes of governance that are better-suited to the context of transformative change. Such an approach recognizes the importance of continually adapting specific measures in response to new developments and learning but also acknowledges that the overarching directionality of policy (commitments, resources, etc.) should be stabilized in order to drive a transition (28).
In summary, the dominant logic of contemporary climate policy, in which carbon pricing is the central policy response, is deeply flawed. Given the aforementioned shortcomings, carbon pricing should not be the primary policy strategy to combat climate change. Instead, carbon pricing should be used as part of a policy mix that promotes innovation and decline, accounts for political dynamics, varies between sectors and over time, and aims at profound system change.
Acknowledgments
D.R. would like to acknowledge the financial support of the Social Sciences and Humanities Research Council of Canada. J.M. acknowledges the Swiss Competence Center for Energy Research, financially supported by Innosuisse under Grant No. KTI 1155000154.
Footnotes
1To whom correspondence may be addressed. Email: daniel.rosenbloom@utoronto.ca.
The authors declare no competing interest.
Any opinions, findings, conclusions, or recommendations expressed in this work are those of the authors and have not been endorsed by the National Academy of Sciences.
*Data are drawn from The World Bank Group’s Carbon Pricing Dashboard.
Published under the PNAS license.
D.R. would like to acknowledge the financial support of the Social Sciences and Humanities Research Council of Canada. J.M. acknowledges the Swiss Competence Center for Energy Research, financially supported by Innosuisse under Grant No. KTI 1155000154.
Footnotes
1To whom correspondence may be addressed. Email: daniel.rosenbloom@utoronto.ca.
The authors declare no competing interest.
Any opinions, findings, conclusions, or recommendations expressed in this work are those of the authors and have not been endorsed by the National Academy of Sciences.
*Data are drawn from The World Bank Group’s Carbon Pricing Dashboard.
Published under the PNAS license.
References
F. W. Geels, B. K. Sovacool, T. Schwanen, S. Sorrell, Sociotechnical transitions for deep decarbonization. Science 357, 1242–1244 (2017).
A. Baranzini et al., Carbon pricing in climate policy: Seven reasons, complementary instruments, and political economy considerations. Wiley Interdiscip. Rev. Clim. Change 8, e462 (2017).
D. Klenert et al., Making carbon pricing work for citizens. Nat. Clim. Chang. 8, 669–677 (2018).
J. E. Stiglitz et al., Report of the High-Level Commission on Carbon prices (World Bank, Washington, DC, 2017).
J. Markard, R. Raven, B. Truffer, Sustainability transitions: An emerging field of research and its prospects. Res. Policy 41, 955–967 (2012).
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COVID-19 Patients Given Unproven Drug In Texas Nursing Home In 'Disconcerting' Move
April 10, 2020 VANESSA ROMO
A bottle of hydroxycloroquine sits on a table outside the entrance to The Resort
at Texas City nursing home, where Robin Armstrong, a doctor and the home's
medical director, is giving the drug to COVID-19 residents.David J. Phillip/AP
Concern is mounting after a doctor at a Texas nursing home started giving the anti-malaria drug hydroxychloroquine to dozens of elderly patients diagnosed with COVID-19 and tracking the outcomes in what he's calling an "observational study."
Use of the drug to treat coronavirus infections has set up a heated debate between the Trump administration and leading health experts over its efficacy against COVID-19.
President Trump has been an enthusiastic champion of hydroxychloroquine, calling it a "game-changer." But some of the nation's most respected health officials have said there is insufficient evidence showing that the 80-year-old drug, which is typically used to stave off malaria or treat lupus and rheumatoid arthritis, is a viable treatment in battling the new virus.
The Food and Drug Administration has not approved the drug for the treatment of COVID-19. The U.S. National Institutes of Health is currently tracking clinical trials of the drug. Additionally, the University of Minnesota is undertaking a trial and Columbia University is as well. Results are not expected for weeks or months.
The controversial decision to administer hydroxychloroquine at The Resort at Texas City over the last few days was made by Robin Armstrong, a physician and medical director of the nursing home.
"It's actually going well. People are getting better," Armstrong told NPR, adding that after just a handful of days, some of the 39 patients on the medication are showing signs of improvement.
But scientists argue that relying on observational, uncontrolled evidence can be misleading and that the only way to truly prove a drug is working is through carefully controlled clinical trials. And, contrary to Armstrong's assertion that hydroxychloroquine "has virtually no side effects," it is known to have serious negative health impacts. That is why so many in the medical community worry about prescribing it without such proof.
Among them is Katherine Seley-Radtke, who is a medicinal chemist at The University of Maryland, Baltimore County. She specializes in antiviral drug research, including coronaviruses.
"This is really disconcerting," Seley-Radtke told NPR.
Armstrong admits it is difficult to quantify how much of his elderly patients' improvement is due to the malaria drug or how they would have fared without it. Nor can he explain why other patients are not responding to the tablet doses, though he notes many are only halfway through the five-day cycle.
"To be clear, no one is worse than when they started," he said emphatically. "From my perspective, it's irresponsible to sit back and do nothing. The alternative would have been much much worse."
In total, 87 people at The Resort tested positive — 56 of 135 residents as well as 31 staffers. One patient has since died.
TEST TEST TEST
"We know how it happened," Armstrong said, explaining that after one staffer tested positive for COVID-19, Galveston County officials tested all other people at the facility on April 2. What they uncovered was one of the largest outbreaks in the Houston region.
"One staffer spread it to other staffers ... and each of them could work with 20 to 30 patients a day," Armstrong said.
Armstrong said he was alarmed by the test results last week and immediately began making calls to track down a source for the medicine, which is in short supply.
That's when his political connections proved useful.
Armstrong, who is a prominent GOP activist, called Republican Lt. Gov. Dan Patrick. He says Patrick reached out to Texas state Sen. Bryan Hughes, also a Republican, who knew someone on the board of the New Jersey-based company Amneal Pharmaceuticals. The company, which makes and distributes the drug, has donated more than a million tablets nationwide, including to the states of Texas and Louisiana.
Two days later, Armstrong had received more than enough medication to begin giving it to patients. He said he started by screening those he believed would benefit most and added more people each day. He monitored their blood oxygen saturation, temperatures and how well they were breathing.
"The people who are on it were getting sicker but were not so sick that they had to go the hospital," Armstrong explained.
He acknowledged that some families were not aware their relatives were put on the drug, saying that "for the most part," he consulted with each nursing home resident prior to giving them on the tablets.
While the "overwhelming majority of them are awake and alert and can actually have a conversation," Armstrong said some suffer from middle stages of dementia. In some cases, he did not discuss prescribing the tablets with anyone at all before doing so. He said it is common for physicians to prescribe new medications to patients without explicit consent from the patient or family members. "It's not required," he said.
He explained he was convinced by clinical studies from Europe and China showing that hydroxychloroquine helps COVID-19 patients recover from the respiratory illness because it works as "essentially an anti-inflammatory drug."
He has some anecdotal evidence: "I've seen it in COVID-19 patients we're treating" at HCA Houston Healthcare Mainland Hospital, Armstrong said.
The health care network confirmed Armstrong is a practicing physician at the hospital but would not comment on treatment of patients because of privacy concerns.
Armstrong said he is tracking the nursing home patients' health changes daily and plans to put his findings in "some kind of report" that he hopes will add to the research on the malarial drug in relation to COVID-19.
"The problem with this is that it's not being conducted in a proper scientific manner," Seley-Radtke said. "It's not being carried out with controls. It's not being carried out under strict testing protocols and using appropriate guidelines."
She noted warnings issued by the FDA that the drug can lead to severe problems for people with heart issues and noted that the agency urges doctors to conduct an EKG before prescribing it. (A step Armstrong said was taken on Thursday.) Another side effect involves damage to the retina.
Because it is still in the experimental stages, how much to use is not clear.
"We know the right dosages for malaria and lupus and rheumatoid arthritis but don't know yet what the right dosages are [for COVID-19], that's why we are doing clinical trials to make sure we get it right," she said.
Seley-Radtke added: "I just find it amazing that everybody, including the President, thinks that this is just no big deal to go ahead and take this."
Armstrong denies he was swayed by politics or Trump's championing of the malaria drug in his decision to implement it at the nursing home before it has been proven safe and effective against COVID-19.
"It's up to a medical professional to determine how and when it would be appropriate to prescribe," Chris Van Deusen, a spokesman for the Texas Department of State Health Services, told NPR.
Armstrong said most COVID-19-positive residents at the nursing home are asking to be on the medication "but we're being very judicious."
Despite the grim tally of positive cases among such a vulnerable population, he said the spread of the virus at the nursing home could have been much worse had staff there not implemented social distancing precautions before they were mandated by the state.
"We took a lot of steps early on that protected a lot of people," he said.
The most recent comprehensive inspection of the facility by Texas Health and Human Services occurred on July 25, 2019, according to a spokesperson.
At the time, the nursing home was cited for 14 violations of state standards. Among them, the report shows:
The facility did not properly care for residents needing special services, including: injections, colostomy, ureterostomy, ileostomy, tracheostomy care, tracheal suctioning, respiratory care, foot care and prostheses.
The facility did not store, cook and give out food in a safe and clean way.
The facility was not designed, built, equipped or well-kept to protect the health and safety of residents, workers and the public.
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