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The U.S. needs an independent regulator with broad authority over medical or scientific research that could create or unleash a pandemic, molecular biologist Alina Chan, Ph.D., suggested in a New York Times opinion essay published Monday.
Chan detailed the risks of gain-of-function research and the gaps in existing oversight. Regardless of whether the COVID-19 pandemic originated in a lab or in nature, another lab leak is likely without regulatory change — especially when research is privately financed or conducted overseas, she wrote.
“If the virus emerged from an animal market, all of the hazards described here remain in play in pathogen research labs, in more countries than ever before,” she wrote.
“If it came out of a laboratory, we already know the price. Either way, unless this research is brought under real supervision, I do not expect the rest of the 21st century to pass without a catastrophic lab leak.”
Gain-of-function research — which alters a pathogen to make it more capable of entering, infecting or causing disease in living cells — has drawn public scrutiny since the COVID-19 origins debate began, as more laboratories worldwide study viruses that could pose risks to humans.
Without robust regulation, public safety depends “on the judgment and the good behavior of individuals,” Chan said. “Scientists are people. Mistakes, bad calls and moments of anger all happen, and pathogens escape from laboratories more often than you might think.”
Molecular biologist Becky McClain, author of “Exposed: A Pfizer Scientist Battles Corruption, Lies, and Betrayal, and Becomes a Biohazard Whistleblower,” told The Defender that Chan’s framing of the problem, and her calls for regulation, were impressive.
However, Chan failed to mention that not just individual scientists, “but also powerful institutions themselves, develop cultures and internal policies to protect liability instead of safety, which wreak havoc upon biosafety and free speech, and threaten the public’s safety,” McClain said.
“The $3 trillion dollar biotech industry, who have a lot of political influence, will obviously make obstacles to such regulations as Chan recommends,” said McClain, a whistleblower who battled Pfizer in the courts for over a decade to get information about the gain-of-function pathogen accident that made her sick.
Network of high-containment labs rapidly expanding
According to Chan, for decades, only a handful of countries operated facilities at the highest biosafety level (BSL), known as BSL-4. Today, there are at least 53 such labs in 22 countries — up from at least 13 in 1999.
That number may be low, because public reporting of such research varies by country, Chan said.
Dangerous pathogens are also studied in less-restrictive laboratories that are more numerous and difficult to track.
Laboratory infections aren’t hypothetical: Chan cited a 2024 review in The Lancet Microbe that identified roughly 300 instances in which laboratory workers became infected with pathogens they were studying between 2000 and 2021 — likely a fraction of the true total, since reporting is voluntary.
Infections can also occur in high-containment facilities. Chan noted that SARS and SARS-like viruses have escaped from BSL-3 and BSL-4 labs on multiple occasions.
Chan pointed to a recent coronavirus study in China, published in the journal Cell. Researchers screened nearly 1,000 bat samples stored at the Wuhan Institute of Virology. They identified relatives of MERS, including a virus capable of entering human cells through a receptor used by the SARS and COVID-19 viruses.
Researchers grew the virus in laboratory versions of human airway, nasal and intestinal cells, where it replicated. The experiments were conducted below the highest levels of biological containment.
When Cell published the study, even Ralph Baric, Ph.D. — who collaborated with Dr. Anthony Fauci and researchers at the Wuhan Institute of Virology on coronavirus research that some link to the COVID-19 pandemic — sounded the alarm about the dangers of the experiment.
Chan also noted that top government officials, including Dr. Francis Collins and Fauci, have for years endorsed and funded this type of research.
Where are the benefits, experts ask?
Where COVID-19 originated remains up for debate. However, Chan, who has argued that COVID-19 likely originated in a laboratory, said the case for stronger oversight of labs and controversial research doesn’t depend on resolving that question.
She is focused on a narrow category of gain-of-function experiments designed to make pathogens more dangerous.
Those in favor of the research say it can help scientists anticipate dangerous mutations or develop countermeasures, including drugs and vaccines. However, critics question whether the potential benefits justify the risk of an accident.
Echoing comments made by the former director of the Centers for Disease Control and Prevention (CDC), Dr. Robert Redfield, to the U.S. House of Representatives Select Subcommittee on the Coronavirus Pandemic, Chan said she is not aware of any gain-of-function research that has led to the development of a drug or vaccine.
“What is missing is a sufficiently scoped, binding standard for regulating pathogen research with catastrophic potential, set and enforced by someone other than the researchers doing the work and the agencies paying for it. No country has one. No international body has the power to establish one.”
Attempts to regulate risky experiments don’t go far enough
The federal government has repeatedly attempted to establish safeguards. A Trump administration policy issued in July bans the most dangerous federally funded experiments, establishes an independent body to review ambiguous cases, and directs that institutions that fail to report covered research lose eligibility for federal funding up to five years.
Chan said the policy leaves three significant gaps: It doesn’t fully cover privately funded research, its review body lacks binding authority over the funding agency, and wild virus-hunting programs can escape independent review even when the pathogens collected could later be used in risky experiments.
Nothing in the new policy requires agencies to review grants already made, and there have been many. A 2024 report by the inspector general found that the U.S. Department of Defense didn’t even track its funding awards in detail and couldn’t determine how much money it had given to Chinese labs for gain-of-function research.
One proposal already before Congress, the Risky Research Review Act, sponsored by Sen. Rand Paul (R-Ky.) and co-sponsored by Sen. Gary Peters (D-Mich.), would establish an independent agency with $30 million in annual funding.
The measure cleared the Senate Homeland Security Committee in an 11-2 vote more than a year ago but hasn’t been voted on by the full Senate.
Chan called the act a starting point, but said it is limited because it covers only federally funded research.
Chan said the risk posed by gain-of-function research warrants the kind of independent oversight already applied to other industries capable of widespread harm — the food, pharmaceutical, financial and nuclear industries.
She called on Congress to go further by establishing an independent regulator modeled partly on the Nuclear Regulatory Commission — one that would impose a uniform national standard regardless of funding source.
The regulator also would oversee the entire process from virus collection to modification, require reporting and independent investigation of suspected accidents, have the authority to stop experiments deemed too dangerous, and centralize the riskiest work in secure facilities away from population centers.
Gain-of-function experts have long called for strict regulations
Chan is not the first person to call for such a commission.
For more than two decades, Rutgers University molecular biologist Richard Ebright, Ph.D., has called for an independent federal entity modeled on the Nuclear Regulatory Commission to oversee research on high-risk pathogens.
In 2022 testimony to the Senate Subcommittee on Emerging Threats and Spending Oversight, Ebright said gain-of-function research “poses high — potentially existential — risks.”
He called for oversight covering all research irrespective of funding source and classification, to be codified into law. Chan’s proposal is similar.
Ebright also argued the U.S. should press other nations to adopt similar oversight systems, and that there should be “an additional, international-level layer of oversight for the highest-risk, highest-consequence subset of gain-of-function research of concern.”
Ebright told The Defender he agreed with Chan’s assessment that without real supervision, it is unlikely that the 21st century will pass without another catastrophic lab leak.
“Indeed, I would go further and affirm that, unless dangerous gain-of-function research is stopped, I do not expect another decade will pass without another catastrophic lab leak,” he said.
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Biolab regulation should include free speech protections for researchers
Bioweapons expert and physician Dr. Meryl Nass, who has advised government officials on gain-of-function policy, has also long drawn attention to the fact that high-containment laboratories suffer continuous, routine and dangerous accidents: 200 per year are reported to the CDC in the U.S. alone, she said.
Nass, who believes gain-of-function research that creates pathogenicity, infectivity or impairs the immune response should be banned because of the risks it poses to public health, said Chan’s proposals were generally quite good.
However, she also noted that Chan lacked clear credentials, with no apparent employment other than an unspecified “adviser” after completing her postdoctoral work in 2018.
She said Chan’s op-ed failed to mention extensive U.S. government funding of gain-of-function research in other countries, and failed to question Baric’s role in blaming the Chinese for mishandling COVID-19 pathogens.
Baric studies the same type of coronaviruses that were being researched at the Wuhan lab, invented the humanized mice used to develop COVID-19 and has been associated with multiple lab mishaps that could potentially induce a pandemic, Nass said.
McClain added one more key recommendation. “All gag orders through confidentiality agreements should be made illegal when it involves any speech concerning biosafety, lab injuries, worker safety or public health and safety.”
“Free speech protections to scientists, physicians and biotech workers should be a primary feature in regulation of biolabs, and making gag orders illegal should be the first step toward that process,” she added.
Related articles in The Defender
- Virologist at Center of Coronavirus Research Loses NIH Grants, University Places Him on Leave
- Trump Bans Most But Not All ‘Dangerous Gain-of-Function Research’
- ‘No Doubt’ Fauci Funded Gain-of-Function Research That Likely Led to Pandemic, Former CDC Director Tells Lawmakers
- Exclusive: Whistleblower Biologist Says Pfizer Covered Up Her Exposure to Engineered Virus, Threatened Family
