No money for energy? Warm yourselves with some billion-dollar biotech research!
ARPA-H is modeled after similar agencies that advance innovation in their sectors, such as the Defense Advanced Research Projects Agency, which is known for contributing to achievements such as the internet, GPS and even Moderna’s vaccine for COVID-19.
If you’re not familiar with DARPA yet, please see these posts first.
What all these ARPAs do is one thing: spend countless billions from public money to do research that’s later handed to private companies through the Public-Private Partnership (PPP) scam. Universities used to provide these services, they still do to a smaller scale, but they can’t be as secretive and can’t be involved in some highly sensitive projects from a national security perspective.
ARPA-H launches path to speed public-private partnerships
The mission of the Advanced Research Projects Agency for Health (ARPA-H) is to advance better health outcomes for everyone. To realize this mission, innovations sparked by ARPA-H must be able to transition into the real world. Transition strategies are often left to the last phase of a program, which significantly reduces the likelihood of a solution to reach the people that need it. ARPA-H seeks to facilitate public-private partnerships for accelerating technology transfer and transition by launching an effort to form Partnership Intermediary Agreements (PIA) that will make transition resources available throughout the entire program life cycle.
“Since the launch of ARPA-H almost a year ago, we have been building the team, tools, and capabilities that each program manager will need in order to launch audacious programs capable of advancing the state of the art in health innovation,” said Renee Wegrzyn, inaugural director of ARPA-H. “The PIA capability is critical to ensure that incoming program managers can hit the ground running and pursue big challenges in health.”
A PIA is an agreement established with a nonprofit partner with deep commercial sector and transition expertise, to engage academia and industry on behalf of the government. Speed and flexibility are the two main advantages of PIAs. PIAs allow for novel approaches that mirror commercial practice to get solutions to market. PIAs are authorized under 15 U.S.C. §3715 to create public-private partnerships.
“We at ARPA-H care deeply about getting solutions to everyone, and this is a powerful tool to ensure those solutions survive in the wild,” said Craig Gravitz, director of ARPA-H’s Project Accelerator Transition Innovation Office (PATIO). “This ensures ARPA-H programs address the market dynamics that matter for success, early and often.” PATIO is ARPA-H’s transition and commercialization office and focuses on ensuring that technologies developed through ARPA-H programs are readily accessible and scalable.
ARPA-H’s PIA application is designed to be easy to understand and implement, enabling potential intermediaries from all eligible communities who may not have deep government expertise to rapidly submit.
The PIA application is now closed. Awards will likely be made approximately 30 days from release date.
Dr. Renee Wegrzyn serves as the first director of the Advanced Research Projects Agency for Health (ARPA-H), appointed on Oct. 11, 2022, by President Joseph R. Biden.
Previously, Wegrzyn served as a vice president of business development at Ginkgo Bioworks and head of innovation at Concentric by Ginkgo, where she focused on applying synthetic biology to outpace infectious diseases – including COVID-19 – through biomanufacturing, vaccine innovation, and biosurveillance of pathogens at scale.
Wegrzyn comes to ARPA-H with experience working for two of the institutions that inspired the creation of the agency – the Defense Advanced Research Projects Agency (DARPA) and Intelligence Advanced Research Projects Activity (IARPA).
As a Program Manager in the DARPA Biological Technologies Office, Wegrzyn leveraged the tools of synthetic biology and gene editing to enhance biosecurity, support the domestic bioeconomy, and thwart biothreats. Her DARPA portfolio included the Living Foundries: 1000 Molecules, Safe Genes; Preemptive Expression of Protective Alleles and Response Elements (PREPARE); and the Detect it with Gene Editing Technologies (DIGET) programs.
Wegrzyn received the Superior Public Service Medal for her work and contributions at DARPA. Prior to joining DARPA, she led technical teams in private industry in the areas of biosecurity, gene therapies, emerging infectious disease, neuromodulation, synthetic biology, as well as research and development teams commercializing multiplex immunoassays and peptide-based disease diagnostics.
Wegrzyn served on the scientific advisory boards for the National Academies Standing Committee on Biotechnology Capabilities and National Security Needs, National Academies of Science Board on Army Research and Development, Revive & Restore, Air Force Research Labs, Nuclear Threat Initiative, and the Innovative Genomics Institute. She holds doctoral and bachelor’s degrees in applied biology from the Georgia Institute of Technology, was a fellow in the Center for Health Security Emerging Leaders in Biosecurity Initiative and completed her postdoctoral training as an Alexander von Humboldt Fellow in Heidelberg, Germany.
With ARPA-H’s billions in Congressional funding and broad mandate to solve intractable health challenges, several audience members asked Wegrzyn what success might look like for the nascent agency. In addition to accelerating breakthroughs in disease prevention and health care delivery, “We want to create tools and products that people want to use,” Wegrzyn said. “We want it to be so obvious to the rest of the world why ARPA-H is here. … So that’ll look like success.” “And paradoxically,” she added, “success should also look like failure.” If the agency doesn’t experience failure, she argues, it may not be taking big enough risks. Another key indicator of success for ARPA-H will be in its diversity — in the problems it solves, in the communities it serves and in the program managers it hires. Spreading the word to people around the world, including those in underrepresented communities, will be pivotal.
The acceleration of COVID-19 testing platforms and vaccine development has demonstrated the possibility of expediting research for similar biomedical breakthroughs. However, the National Institutes of Health (NIH) lacks a framework to regularly sustain this type of research. A new federal agency, the Advanced Research Projects Agency for Health (ARPA-H), offers a unique opportunity to capitalize on the lessons learned from the COVID-19 pandemic and drive federal investment into high-risk, high-reward biomedical research. ARPA-H will mirror the flat bureaucratic structure of the successful Defense Advanced Research Projects Agency (DARPA) through the employment of independent project managers. ARPA-H is also unique in how it centers equity in the agency’s core mission. These unique traits could enable the agency to fill the gaps in current biomedical research under the NIH. Nonetheless, ARPA-H’s implementation is not without challenges: its incorporation within the NIH has raised concerns regarding its ability to specialize in high-risk research and the diversion of funding away from the rest of the NIH. These worries can be mitigated through the separation of ARPA-H and the NIH. Successful implementation of the ARPA-H framework would supplement current NIH work, diversify the US federal research strategy, accelerate promising breakthroughs, promote equity in health, and transform the nature of biomedical research in the US.
And this is not the last ARPA you’ll hear about. We’re in a world of ARPAs.
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! Articles can always be subject of later editing as a way of perfecting them
We’ve all heard of existing cancer cures, whether you believe in them or not, you can’t rationally hope they will be made available to plebs for as long a Pharmafia exists.
Goldman Sachs asks in biotech research report: ‘Is curing patients a sustainable business model?’
Goldman Sachs analysts attempted to address a touchy subject for biotech companies, especially those involved in the pioneering “gene therapy” treatment: cures could be bad for business in the long run.
“Is curing patients a sustainable business model?” analysts ask in an April 10 report entitled “The Genome Revolution.”
“The potential to deliver ‘one shot cures’ is one of the most attractive aspects of gene therapy, genetically-engineered cell therapy and gene editing. However, such treatments offer a very different outlook with regard to recurring revenue versus chronic therapies,” analyst Salveen Richter wrote in the note to clients Tuesday. “While this proposition carries tremendous value for patients and society, it could represent a challenge for genome medicine developers looking for sustained cash flow.”
Richter cited Gilead Sciences’ treatments for hepatitis C, which achieved cure rates of more than 90 percent. The company’s U.S. sales for these hepatitis C treatments peaked at $12.5 billion in 2015, but have been falling ever since. Goldman estimates the U.S. sales for these treatments will be less than $4 billion this year, according to a table in the report.
“Gilead is a case in point, where the success of its hepatitis C franchise has gradually exhausted the available pool of treatable patients,” the analyst wrote. “In the case of infectious diseases such as hepatitis C, curing existing patients also decreases the number of carriers able to transmit the virus to new patients, thus the incident pool also declines … Where an incident pool remains stable (eg, in cancer) the potential for a cure poses less risk to the sustainability of a franchise.”
The analyst didn’t immediately respond to a request for comment.
The report suggested three potential solutions for biotech firms:
“Solution 1: Address large markets: Hemophilia is a $9-10bn WW market (hemophilia A, B), growing at ~6-7% annually.”
“Solution 2: Address disorders with high incidence: Spinal muscular atrophy (SMA) affects the cells (neurons) in the spinal cord, impacting the ability to walk, eat, or breathe.”
“Solution 3: Constant innovation and portfolio expansion: There are hundreds of inherited retinal diseases (genetics forms of blindness) … Pace of innovation will also play a role as future programs can offset the declining revenue trajectory of prior assets.”
So you don’t see anyone pushing for any cures.
CONSUMER AFFAIRS
Biden’s moonshot examined: Researchers say cancer cure is a long ways off
The White House is pressing ahead, saying a combination of research on cures and prevention efforts will end the scourge.
Congress has appropriated $1.8 billion for the “cancer moonshot” President Joe Biden began in 2016, and the positive reaction to Biden’s request for more suggests it’s eager to maintain the momentum. | Evan Vucci/AP Photo
President Joe Biden’s pledge to “end cancer as we know it” is a rare sliver of common ground between Democrats and Republicans.
Congress has appropriated $1.8 billion for the “cancer moonshot” Biden began in 2016, and the positive reaction to Biden’s request for more during Tuesday’s State of the Union suggests it’s eager to maintain the momentum.
But cancer researchers are less unified about the moonshot than Washington policymakers. A contrarian cadre question whether the money appropriated is being well spent. Cancer research is funded well enough, they said, and investing more in high-tech individualized treatments is more likely to help the wealthy live longer than it is to save those most likely to die of the disease: the poor and people of color.
“It’s a lot harder than getting a man to the moon,” Gilbert Welch, an internist and senior investigator at the Center for Surgery and Public Health at Brigham and Women’s Hospital in Boston, said of curing cancer. “It’s a very complex set of diseases. You need to think of it as a family of diseases. The moon is just one thing. Just gotta get there. This is hundreds of different things.”
Biden wants to press ahead on a bipartisan initiative. He has called on Congress to maintain funding for the 2016 law that launched the moonshot, the 21st Century Cures Act. He pledged to cut cancer death rates by 50 percent in the next 25 years and to turn fatal cancers into treatable diseases.
Biden also has asked Congress to reauthorize the National Cancer Act, signed into law by President Richard Nixon in 1971. Reauthorization would help the National Cancer Institute support researchers around the country by building clinical trial networks and more robust data systems, according to Danielle Carnival, the White House’s moonshot coordinator.
But some experts, such as Ezekiel Emanuel, an oncologist, a professor at the University of Pennsylvania and former White House adviser, said there’s plenty of money devoted to cancer research. The National Cancer Institute had a nearly $6.4 billion budget for cancer research in 2021 and its annual spend has been growing since 2015. Cancer non-profits like the American Cancer Institute also raise hundreds of millions of dollars every year.
President Joe Biden has asked Congress to reauthorize the National Cancer Act, signed into law by President Richard Nixon in 1971. | AP Photo
Additionally, the pharmaceutical industry is incentivized to put money behind increasingly lucrative cancer diagnostics and therapeutics. Research shows that from 2010 to 2019 revenue generated from cancer medicines increased 70 percent among the top 10 pharmaceutical companies to reach $95 billion.
And not everyone thinks more funding is a good thing. “There’s so much money sloshing around,” Welch said of the cancer industry, adding, “Both academic and biotech or industry are excessively enthusiastic and just trying to put out as many products as they can.”
We’ve overinvested in cancer, according to Welch, especially in expensive cancer drugs with modest or unproven benefit for patients and in screenings — Welch’s research area. He’s particularly opposed to the Medicare Multi-Cancer Early Detection Screening Coverage Act, sponsored by Sen. Mike Crapo (R-Idaho) and Rep. Terri Sewell (D-Ala.), which would require Medicare to cover cancer blood tests if they’re approved by the FDA. From Welch’s vantage point, benefits from screenings have been exaggerated, while its harms have been minimized.
Other critics, such as Keith Humphreys, a public health professor at Stanford University who has published academic articles on the link between alcohol use and cancer, see cancer prevention as a more immediate way to save lives.
Managing disease and curing it
The president’s agenda goes beyond money, Carnival told POLITICO, emphasizing prevention efforts, such as improving nutrition for kids, discouraging smoking, and decreasing environmental risks.
“We’re going to have to reach more people with the tools we already have and those we develop along the way,” Carnival said. “The purview is much broader than research. I don’t think anyone would say we have all of the research advancements and knowledge and treatments that we need today to end cancer as we know it.”
Those closely involved in developing cutting-edge cancer therapeutics said the field has shifted dramatically in recent years. It’s gone from treating cancer as a chronic disease, to trying to cure patients.
During his medical fellowship in the early 2000s, improving patient survival by months or years was the goal, explained Marco Davila, a physician-scientist at Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., who helped pioneer some of the first CAR-T cell therapies for patients with blood cancer.
Since then, treatment breakthroughs for some previously incurable cancer have upended the cancer-as-chronic-disease philosophy. Now, doctors and researchers believe cancer-curing therapies are within reach. “It’s changed the nature of how we manage patients. There’s that option there. It’s on the table,” Davila said.
For Davila, moonshot funds earmarked for cancer research and therapies created a new pool of money for his work. It doesn’t fix the problem of underfunded science as a whole, he said, but it makes his work as a cancer researcher a priority.
“It’s great for us, because that’s our field. It’s also great for patients, because cancer is still going to be one of the most common causes of people’s death in the United States,” Davila said. (In the U.S., it’s second behind heart disease, taking more than 600,000 lives in 2020, the most recent year for which there are statistics.)
Indeed, since the late 1980s, scientists have developed effective treatments for lung cancer, breast cancer and Hodgkin’s lymphoma. There are caveats, of course. They don’t work for all patients.
“It’s maybe 20 percent, 30 percent,” Davila said. The goal now is to keep improving those cure rates over time — to 50 percent or 60 percent, for example.
“Will it get to 100 percent in your lifetime? I don’t know,” he said.
What Davila does know is that each 10 percent cure-rate increase means saving tens of thousands, or even hundreds of thousands of lives.
‘Prevention takes action’
But some cancer experts said there’s a downside to the shift toward precision medicine and individualized treatments. Attempting to test everyone or characterize every tumor more precisely is a bit of magical thinking, according to Welch.
“The more you subset people, the more difficult it is to know whether your treatments help. It’s too small of a group,” Welch said. “It used to be just lung cancer. Now we’ve got eight genetic variants we’re testing in adenocarcinomas of the lung,” he added.
“Ironically, the more precise we get, the more types of cancer there are, as we genetically signature each cancer, all of a sudden we don’t really know what to do with any one of them.”
Others think there needs to be a fundamental shift away from screening and treatment and toward preventing cancer in the first place.
“It’s terrific when we develop new treatments for cancer, but it certainly is always better to prevent something than to treat it,” said Humphreys, who served as a drug policy adviser under Presidents George W. Bush and Barack Obama.
“Very high-end, complicated treatments are never going to be accessible to the whole population,” he added. “Congress could definitely do more.”
“We have very good evidence that when we raise the federal alcohol tax that fewer people die.”
Keith Humphreys, public health professor at Stanford University
Tobacco taxation is widely considered one of the most effective practices in preventing people from starting to smoke in the first place, leading existing smokers to quit, and reducing deaths from tobacco-related cancers. Humphreys said Congress could take the same taxation approach to the alcohol industry. “We have very good evidence that when we raise the federal alcohol tax that fewer people die,” he said.
While broad blood-based cancer screening may not be a cost-effective strategy for stopping cancer early, targeted cancer screening for colorectal, breast, cervical, prostate, and lung cancers could be. Rules could stoke participation or ensure that patients on Medicaid, who are more likely to be at risk of cancer, are getting regular screenings.
“It’s important to acknowledge that our biggest success in cancer really reflects prevention,” Welch said. “It’s nothing fancy. It’s discouraging cigarette smoking.”
There’s a lot of money already in the moonshot cancer system. It just needs to be redirected and allocated differently, said Ezekiel Emanuel, an oncologist and former White House adviser.
The White House touts prevention in its moonshot agenda. In 2022, the first year of the reignited moonshot, the FDA proposed rules to prohibit menthol cigarettes. Among other agenda items, the moonshot program plans to increase cancer screenings in at-risk communities and facilitate donations of sunscreen to schools and youth organizations.
But prevention is a trickier cancer-prevention mechanism than treatment. It could mean cleaning up Superfund sites or removing lead pipes to reduce environmental cancer risk. It often requires people to change their behavior — to drink less alcohol and exercise more or stop smoking — a more challenging mission at the population level than directing patients to take a pill or offering them a diagnostic test.
“It’s not necessarily clear how one spends money on prevention,” Welch acknowledged. “It’s much easier to sell a test or a drug. It’s a concrete thing. Prevention takes action on the part of individuals,” he said. “You gotta say, that’s harder.”
More funding wouldn’t necessarily solve the problem, according to Emanuel.
There’s a lot of money already in the system. It just needs to be redirected and allocated differently, Emanuel explained.
Who is spending that money also matters. The government sponsors roughly one-third of clinical cancer research, according to Emanuel. Industry accounts for the remaining two-thirds of funding. “It’s good that they’ve got a lot of drugs that they’re testing. What’s bad is having industry shape the clinical research agenda, because industry has a bias.”
Emanuel’s solution: stronger government leadership and more non-industry sponsors.
“The NCI [National Cancer Institute] is the biggest NIH institute,” Emanuel said. “It’s not exactly like they’re starving.”
You also have to be a monster to sell halving the cases long after your death as a “cure”
Biden keeps rambling about curing cancer because he and Obama set up and funded the delusional mRNA industry, which was initially aimed at cancer. The Moderna guys promised him this and he ran with it. He still does, poor dumb fv<k…
And if you have a MAGA hat, don’t flash it before reading this:
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! Articles can always be subject of later editing as a way of perfecting them
The USA TODAY Network’s “Biolabs in Your Backyard” investigation, published since 2015, has revealed hundreds of accidents at corporate, university, government and military labs nationwide. It also has exposed a system of fragmented federal oversight and pervasive secrecy that obscures failings by facilities and regulators.
In January 2015, in an effort to determine the extent of lab accidents at the agency’s facilities, USA TODAY filed a FOIA request seeking copies of all incident reports at CDC labs in Atlanta and Fort Collins during 2013 and 2014. The CDC granted the request “expedited” processing status because USA TODAY demonstrated a compelling public need for the information. But the agency has said it will likely be 2018 before the records are released.
The newly disclosed 2009 incident in the BSL-4 decontamination shower is among about 4,000 pages of records the agency released in late January in response to two FOIA requests USA TODAY filed in June 2012. Those requests sought records about airflow and security door incidents at CDC’s $214 million, 368,000-square-foot Emerging Infectious Diseases Laboratory in Atlanta, commonly referred to by the agency as Building 18.
Most of these released records — which focus on airflow engineering issues in labs — involve a 2012 incident that USA TODAY reported four years ago based on documents obtained from sources. The issue involved air from inside a potentially contaminated lab briefly blowing outward into a “clean” corridor where a group of visitors weren’t wearing any protective gear. Among other incidents revealed in the records:
In 2011, a worker feeding animals in an enhanced biosafety level 3 lab used for studies on dangerous strains of avian flu, was unable to shower out of the lab after a construction contractor mistakenly closed the wrong water valve in a service tunnel. Not knowing when the water would come back on, the worker removed her protective equipment, put on a clean protective suit and left the lab without taking a shower. “I escorted her through the service tunnel to building (redacted) where she signed into our (redacted) select agent laboratory. She disposed of the tyvek suit in a biohazard bag, placed her scrubs in the laundry bin, and took a personal shower.” The CDC told USA TODAY that because the potential for any exposure was considered low risk, a medical evaluation was not required.
In 2008 an unvaccinated repair worker was potentially exposed to an undisclosed pathogen when a door containing contaminated items unexpectedly opened in a malfunctioning device, called an autoclave, that is used to sterilize equipment and other items. The infectious materials inside the device included bedding from infected mice and used laundry. While a report of the incident said that any material that may have escaped through the clean-side door that opened “was likely to be drawn upward toward the exhaust,” the worker was told to shower and his clothes, shoes, wallet, watch and other personal items were disinfected. He was escorted to the clinic for evaluation. The report notes that the autoclave “was installed backwards during building construction” and that as a result, the manual override controls for doors are reversed “which ultimately resulted in the incident.”
Building 18, which opened in 2005 has had a series of significant issues over the years. While the building’s many other high-containment and lower security labs were in operation from the start, its suite of BSL-4 labs did not go “hot” and start working with pathogens until around early 2009. The lab complex made news in 2007 when backup generators didn’t work to keep airflow systems working during a power outage and in 2008 for high-containment lab door that was being sealed with duct tape. The duct tape was applied after a 2007 incident where the building’s ventilation system malfunctioned and pulled potentially contaminated air out of the lab and into a “clean” hallway. Nine CDC workers were tested for potential exposure to Q fever bacteria. None were infected.
Read all the records released by CDC in response to USA TODAY’s 2012 Freedom of Information Act requests here and here.
The full coverage of USA TODAY’s investigation used to be hosted on its own separate website, biolabs.usatoday.com , but they deleted it, unsurprisingly.
As we’ve shown in our video too, a wide range of mainstream media outlets have reflected the situation over the years, not just USA Today, being quite critical of it, but with almost no impact on the general population. Ah, well…
Why some labs work on making viruses deadlier — and why they should stop
The pandemic should make us question the value of gain-of-function research.
Editor’s note, June 7, 2021: Since this article was originally published in May 2020, scientific consensus has shifted. Now some experts say the “lab leak” theory warrants an investigation, along with the natural origin theory. The article has been updated to reflect this, but other information may be out of date. For our most up-to-date coverage of the coronavirus pandemic, visit Vox’s coronavirus hub.
Earlier this week, Newsweek and the Washington Post reported that the Wuhan Institute of Virology, a lab near the site of the first coronavirus cases in the world, had been studying bat coronaviruses.
The Newsweek report revealed an alarming tidbit: The Wuhan lab at the center of the controversy had for years been engaged in gain-of-function research. What exactly is it? It’s a line of research where scientists take viruses and study how they might be modified to become deadlier or more transmissible. Why would they do this? Scientists who engage in such research say it helps them figure out which viruses threaten people so they can design countermeasures.
To be clear, there is no evidence that the novel coronavirus, SARS-CoV-2, was released on purpose, and many experts believe it is likely to have been the result of accidental transmission through human contact with wild animals, like almost all disease outbreaks in history have been.
But the emerging reports about the lab in Wuhan are making many people aware for the first time that gain-of-function research happens at all. I wouldn’t blame you if your response to this news is this: The government gives grants to researchers to make potentially pandemic viruses deadlier and to make them transmissible more easily between people? Why are we doing that?
The increased attention to gain-of-function research is a good thing. This kind of highly controversial research — banned under the Obama administration after safety incidents demonstrated that lab containment is rarely airtight — began again under the Trump administration, and many scientists and public health researchers think it’s a really bad idea. Our brush with the horrors of a pandemic might force us to reconsider the warnings those experts have been sounding for years.
The US stopped funding gain-of-function research. Then it started again.
In 2019, Science magazine broke the news that the US government resumed funding two controversial experiments to make the bird flu more transmissible.
The two experiments had been on hold since 2012 amid a fierce debate in the virology community about gain-of-function research. In 2014, the US government, under the Obama administration, declared a moratorium on such research.
It was in that context that scientists and biosecurity experts found themselves embroiled in a debate about gain-of-function research. The scientists who do this kind of research argue that we can better anticipate deadly diseases by making diseases deadlier in the lab. But many people at the time and since have become increasingly convinced that the potential research benefits — which look limited — just don’t outweigh the risks of kicking off the next deadly pandemic ourselves.
While internally divided, the US government came down on the side of caution at the time. It announced a moratorium on funding gain-of-function research — putting potentially dangerous experiments on hold so the world could discuss the risks this research entailed.
But in 2017, the government under the Trump administrationreleased new guidelines for gain-of-function research, signaling an end to the blanket moratorium. And the news from 2019 suggests that dangerous projects are proceeding.
Experts in biosecurity are concerned the field is heading toward a mistake that could kill innocent people. They argue that, to move ahead with research like this, there should be a transparent process with global stakeholders at the table. After all, if anything goes wrong, the mess we’ll face will certainly be a global one.
Should we really be doing this kind of research?
Advocates of this kind of gain-of-function research (not all gain-of-function research uses pathogens that can cause pandemics) point to a few things they hope it will enable us to do.
In general, they argue it will enhance surveillance and monitoring for new potential pandemics. As part of our efforts to thwart pandemics before they start — or before they get severe — we take samples of the viruses currently circulating. If we know what the deadliest and most dangerous strains out there are, the argument goes, then we’ll be able to monitor for them and prepare a response if it looks like such mutations are arising in the wild.
“As coordination of international surveillance activities and global sharing of viruses improve,” some advocates wrote in mBio, we’ll get better at learning which strains are out there. Then, gain-of-function research will tell us which ones are close to becoming deadly.
“GOF data have been used to launch outbreak investigations and allocate resources (e.g., H5N1 in Cambodia), to develop criteria for the Influenza Risk Assessment Tool, and to make difficult and sometimes costly pandemic planning policy decisions,” they argue.
“The United States government weighed the risks and benefits … and developed new oversight mechanisms. We know that it does carry risks. We also believe it is important work to protect human health,” Yoshihiro Kawaoka, an investigator whose gain-of-function research was approved, told Science magazine.
According to this logic, if we’d known for years that the SARS-CoV-2 coronavirus — the virus now keeping us all indoors — was a particularly dangerous one, maybe we could have had disease surveillance systems out to alert us if it made the jump to humans.
Others are skeptical. Thomas Inglesby, director of the Center for Health Security at Johns Hopkins, told me last year that he doesn’t think the benefits for vaccine development hold up in most cases. “I haven’t seen any of the vaccine companies say that they need to do this work in order to make vaccines,” he pointed out. “I have not seen evidence that the information people are pursuing could be put into widespread use in the field.”
Furthermore, there are unimaginably many possible variants on a virus, of which researchers can identify only a few. Even if we stumble across one way a virus could mutate to become deadly, we might miss thousands of others. “It’s an open question whether laboratory studies are going to come up with the same solution that nature would,” MIT biologist Kevin Esvelt told me last year. “How predictive are these studies really?” As of right now, that’s still an open question.
And even in the best case, the utility of this work would be sharply limited. “It’s important to keep in mind that many countries do not have mechanisms in place at all — much less a real-time way to identify and reduce or eliminate risks as experiments and new technologies are conceived,” Beth Cameron, the Nuclear Threat Initiative’s vice president for global biological policy and programs, told me.
With the stakes so high, many researchers are frustrated that the US government was not more transparent about which considerations prompted them to fund the research. Is it really necessary to study how to make H5N1, which causes a type of bird flu with an eye-popping mortality rate, more transmissible? Will precautions be in place to make it harder for the virus to escape the lab? What are the expected benefits from the research, and which hazards did the experts who approved the work consider?
“The people proposing the work are highly respected virologists,” Inglesby said. “But laboratory systems are not infallible, and even in the greatest laboratories of the world, there are mistakes.” What measures are in place to prevent that? Will potentially dangerous results be published to the whole world, where unscrupulous actors could follow the instructions?
These are exactly the questions the review process was supposed to answer, but didn’t.
Sometimes pathogens escape from the lab. Here’s how it happens.
The reason the subject of gain-of-function research can inspire such heated opposition is because the stakes can be so high. Pathogens have escaped labs before.
Take smallpox, once one of the deadliest diseases.
In 1977, the last case of smallpox was diagnosed in the wild. The victim was Ali Maow Maalin of Somalia. The World Health Organization tracked down every person he’d been in face-to-face contact with to vaccinate everyone at risk and find anyone who might have caught the virus already. Thankfully, they found no one had. Maalin recovered, and smallpox appeared to be over forever.
That moment came at the end of a decades-long campaign to eradicate smallpox — a deadly infectious disease that killed about 30 percent of those who contracted it — from the face of the Earth. Around 500 million people died of smallpox in the century before it was annihilated.
But in 1978, the disease cropped back up — in Birmingham, England. Janet Parker was a photographer at Birmingham Medical School. When she developed a horrifying rash, doctors initially brushed it off as chicken pox. After all, everyone knew smallpox had been chased out of the world — right?
Parker got worse and was admitted to the hospital, where testing determined she had smallpox after all. She died of it a few weeks later.
How did she get a disease that was supposed to have been eradicated?
It turned out that the building Parker worked in also contained a research laboratory, one of a handful where smallpox was studied by scientists who were trying to contribute to the eradication effort. Some papersreported the lab was badly mismanaged, with important precautions ignored because of haste. (The doctor who ran the lab died by suicide shortly after Parker was diagnosed.) Somehow, smallpox escaped the lab to infect an employee elsewhere in the building. Through sheer luck and a rapid response from health authorities, including a quarantine of more than 300 people, the deadly error didn’t turn into an outright pandemic.
In 2014, as the Food and Drug Administration did cleanup for a planned move to a new office, hundreds of unclaimed vials of virus samples were found in a cardboard box in the corner of a cold storage room. Six of them, it turned out, were vials of smallpox. No one had been keeping track of them; no one knew they were there. They may have been there since the 1960s.
Panicked scientists put the materials in a box, sealed it with clear packaging tape, and carried it to a supervisor’s office. (This is not approved handling of dangerous biological materials.) It was later found that the integrity of one vial was compromised — luckily, not one containing a deadly virus.
The 1979 and 2014 incidents grabbed attention because they involved smallpox, but incidents of unintended exposure to controlled biological agents are actually quite common. Hundreds of incidents occur every year, though not all involve potentially pandemic-causing pathogens.
In 2014, a researcher accidentally contaminated a vial of a fairly harmless bird flu with a far-deadlier strain. The deadlier bird flu was then shipped across the country to a lab that didn’t have authorization to handle such a dangerous virus, where it was used for research on chickens.
The mistake was discovered only when the Centers for Disease Control and Prevention conducted an extensive investigation in the aftermath of a different mistake — the potential exposure of 75 federal employees to live anthrax, after a lab that was supposed to inactivate the anthrax samples accidentally prepared activated ones.
The CDC’s Select Agents and Toxins program requires “theft, loss, release causing an occupational exposure, or release outside of primary biocontainment barriers” of agents on its watchlist be immediately reported. Between 2005 and 2012, the agency got 1,059 release reports — an average of one incident every few days. Here are a few examples:
In 2009, a new high-security bioresearch facility — rated to handle Ebola, smallpox, and other dangerous pathogens — had its decontamination showers fail. The pressurized chamber kept losing pressure and the door back into the lab kept bursting open while the scientists leaned against it to try to keep it closed. Building engineers were eventually called to handle the chemical showers manually.
In 2011, a worker at a lab that studied dangerous strains of bird flu found herself unable to shower after a construction contractor accidentally shut off the water. She removed her protective equipment and left without taking a decontaminating shower. (She was escorted to another building and showered there, but pathogens could have been released in the meantime.)
Now, the vast majority of these mistakes never infect anyone. And while 1,059 is an eye-popping number of accidents, it actually reflects a fairly low rate of accidents — working in a controlled biological agents lab is safe compared to many occupations, like trucking or fishing.
But a trucking or fishing accident will, at worst, kill a few dozen people, while a pandemic pathogen accident could potentially kill a few million. Considering the stakes and worst-case scenarios involved, it’s hard to look at those numbers and conclude that our precautions against disaster are sufficient.
Reviewing the incidents, it looks like there are many different points of failure — machinery that’s part of the containment process malfunctions;regulations aren’t sufficient or aren’t followed. Human error means live viruses are handled instead of dead ones.
Now imagine such an error involving viruses enhanced through gain-of-function research. “If an enhanced novel strain of flu escaped from a laboratory and then went on to cause a pandemic, then causing millions of deaths is a serious risk,” Marc Lipsitch, a professor of epidemiology at Harvard University, told me last year.
The cost-benefit analysis for pathogens that might kill the people exposed or a handful of others is vastly different from the cost-benefit analysis for pathogens that could cause a pandemic — but our current procedures don’t really account for that. As a result, allowing gain-of-function research meansrunning unacceptable risks with millions of lives. It’s high time to rethink that.
nyt: Deadly Germ Research Is Shut Down at Army Lab Over Safety Concerns
Problems with disposal of dangerous materials led the government to suspend research at the military’s leading biodefense center.
Denise Braun prepared to demonstrate lab work during a media tour at the Army Medical Research Institute of Infectious Diseases in Fort Detrick, Md., in 2011.CreditCreditPatrick Semansky/Associated Press
Safety concerns at a prominent military germ lab have led the government to shut down research involving dangerous microbes like the Ebola virus.
“Research is currently on hold,” the United States Army Medical Research Institute of Infectious Diseases, in Fort Detrick, Md., said in a statement on Friday. The shutdown is likely to last months, Caree Vander Linden, a spokeswoman, said in an interview.
The statement said the Centers for Disease Control and Prevention decided to issue a “cease and desist order” last month to halt the research at Fort Detrick because the center did not have “sufficient systems in place to decontaminate wastewater” from its highest-security labs.
But there has been no threat to public health, no injuries to employees and no leaks of dangerous material outside the laboratory, Ms. Vander Linden said.
In the statement, the C.D.C. cited “national security reasons” as the rationale for not releasing information about its decision.
The institute is a biodefense center that studies germs and toxins that could be used to threaten the military or public health, and also investigates disease outbreaks. It carries out research projects for government agencies, universities and drug companies, which pay for the work. It has about 900 employees.
The shutdown affects a significant portion of the research normally conducted there, Ms. Vander Linden said.
The suspended research involves certain toxins, along with germs called select agents, which the government has determined have “the potential to pose a severe threat to public, animal or plant health or to animal or plant products.” There are 67 select agents and toxins; examples include the organisms that cause Ebola, smallpox, anthrax and plague, and the poison ricin.
In theory, terrorists could use select agents as weapons, so the government requires any organization that wants to handle them to pass a background check, register, follow safety and security procedures, and undergo inspections through a program run by the C.D.C. and the United States Department of Agriculture. As of 2017, 263 laboratories — government, academic, commercial or private — had registered with the program.
The institute at Fort Detrick was part of the select agent program until its registration was suspended last month, after the C.D.C. ordered it to stop conducting the research.
The problems date back to May 2018, when storms flooded and ruined a decades-old steam sterilization plant that the institute had been using to treat wastewater from its labs, Ms. Vander Linden said. The damage halted research for months, until the institute developed a new decontamination system using chemicals.
The new system required changes in certain procedures in the laboratories. During an inspection in June, the C.D.C. found that the new procedures were not being followed consistently. Inspectors also found mechanical problems with the chemical-based decontamination system, as well as leaks, Ms. Vander Linden said, though she added that the leaks were within the lab and not to the outside world.
“A combination of things” led to the cease and desist order, and the loss of registration, she said.
Dr. Richard H. Ebright, a molecular biologist and bioweapons expert at Rutgers University, said in an email that problems with the institute’s new chemical-based decontamination process might mean it would have to go back to a heat-based system “which, if it requires constructing a new steam sterilization plant, could entail very long delays and very high costs.”
Although many projects are on hold, Ms. Vander Linden said scientists and other employees are continuing to work, just not on select agents. She said many were worried about not being able meet deadlines for their projects.
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