Using an adjusted odds ratio, the researchers found that vaccination reduced the likelihood of developing long COVID with one or more symptoms by 57 percent, and reduced the likelihood of developing long COVID with two or more symptoms by 73 percent. Vaccination prior to infection was also linked to a 75 percent reduction in risk of developing long COVID that impacted day-to-day functioning. The authors note that the estimates of protection are likely underestimates because the calculations do not account for the fact that vaccination prevented some children from getting infected in the first place.
“Our findings suggest that children should stay up to date with current COVID-19 vaccination recommendations as vaccination not only protects against severe COVID-19 illness but also protects against [long Covid],” the authors conclude.
In a second short report in JAMA Network Open, researchers helped dispel concern that the vaccines could cause sudden cardiac arrest or sudden cardiac death in young athletes. This is an unproven claim that was fueled by anti-vaccine advocates amid the pandemic, including the new US Health Secretary and long-time anti-vaccine advocate Robert F. Kennedy Jr.
While previous analyses have failed to find a link between COVID-19 vaccines and sudden cardiac deaths, the new study took a broader approach. The study, led by researchers at the University of Washington, looked at whether the number of sudden cardiac arrests (SCA) and sudden cardiac deaths (SCD) among young athletes changed at all during the pandemic (2020–2022) compared with prior years (2017–2019). The researchers drew records from the National Center for Catastrophic Sports Injury Research. They also collected medical records and autopsy reports on cases among competitive athletes from the youth, middle school, high school, club, college, or professional levels who experienced sudden cardiac arrest or death at any time.
In all, there were 387 cases, with no statistically significant difference in the number of cases in the years prior to the pandemic (203) compared with those during the pandemic (184).
“This cohort study found no increase in SCA/SCD in young competitive athletes in the US during the COVID-19 pandemic, suggesting that reports asserting otherwise were overestimating the cardiovascular risk of COVID-19 infection, vaccination, and myocarditis,” the authors conclude.
“Rather than instructing individuals to receive any and all vaccines, LDH staff should communicate data regarding the reduced risk of disease, hospitalization, and death associated with a vaccine and encourage individuals to discuss considerations for vaccination with their healthcare provider,” he wrote.
“Ripped in half”
Susan Hassig, an infectious disease epidemiologist and professor emerita at Tulane University’s School of Public Health, told the Times-Picayune that this is problematic advice. Many people don’t have primary care providers. “They go to an urgent care or a clinic,” Hassig said. “In Louisiana, they go to the emergency room.”
The memo lands amid widespread fear that Kennedy’s appointment will lead to further erosion of America’s trust in vaccination and its vaccination rates. Already, rates of routine childhood vaccination in kindergartners across the nation have slipped into the range of 92 percent, woefully below the 95 percent threshold to prevent onward disease spread. Exemptions from school vaccination requirements are at an all-time high.
Further, the country is also in the midst of the worst flu season in 15 years. The percent of doctor’s visits for influenza-like illnesses (a standard metric for flu season) hit 7.8 percent this week, a high not seen since the 2009–2010 season amid the emergence of the H1N1 swine flu. The Centers for Disease Control and Prevention estimates that there have been at least 29 million illnesses, 370,000 hospitalizations, and 16,000 deaths from flu so far this season. This week, 11 children died of flu, bringing the 2024–2025 pediatric death toll to 68.
Among the recent deaths was a healthy 9-year-old girl in North Carolina, who died from flu complications on January 29. “I literally feel like my heart has been ripped in half,” her mother told WRAL News.
“The short-lived immunity leads to repeated waves of infection, mirroring patterns observed with common cold coronaviruses and influenza,” Hiam Chemaitelly, first author of the study and assistant professor of population health sciences at Weill Cornell Medicine-Qatar, said in a statement. “This virus is here to stay and will continue to reinfect us, much like other common cold coronaviruses. Regular vaccine updates are critical for renewing immunity and protecting vulnerable populations, particularly the elderly and those with underlying health conditions.”
Chemaitelly and colleagues speculate that the shift in the pandemic came from shifts in evolutionary pressures that the virus faced. In early stages of the global crisis, the virus evolved and spread by increasing its transmissibility. Then, as the virus lapped the globe and populations began building up immunity, the virus faced pressure to evade that immunity.
However, the fact that researchers did not find such diminished protection against severe, deadly COVID-19 suggests that the evasion is likely targeting only certain components of our immune system. Generally, neutralizing antibodies, which can block viral entry into cells, are the primary protection against non-severe infection. On the other hand, immunity against severe disease is through cellular mechanisms, such as memory T cells, which appear unaffected by the pandemic shift, the researchers write.
Overall, the study “highlights the dynamic interplay between viral evolution and host immunity, necessitating continued monitoring of the virus and its evolution, as well as periodic updates of SARS-CoV-2 vaccines to restore immunity and counter continuing viral immune evasion,” Chemaitelly and colleagues conclude.
In the US, the future of annual vaccine updates may be in question, however. Prominent anti-vaccine advocate and conspiracy theorist Robert F. Kennedy Jr. is poised to become the country’s top health official, pending Senate confirmation next week. In 2021, as omicron was rampaging through the country for the first time, Kennedy filed a petition with the Food and Drug Administration to revoke access and block approval of all current and future COVID-19 vaccines.
Their investigative report—based on interviews with multiple health department employees who spoke on the condition of anonymity for fear of retaliation—revealed that employees were told of the startling policy change in meetings in October and November and that the policy would be implemented quietly and not put into writing.
Ars Technica has contacted the health department for comment and will update this post with any new information.
The health department provided a statement to NPR saying that it has been “reevaluating both the state’s public health priorities as well as our messaging around vaccine promotion, especially for COVID-19 and influenza.” The statement described the change as a move “away from one-size-fits-all paternalistic guidance” to a stance in which “immunization for any vaccine, along with practices like mask wearing and social distancing, are an individual’s personal choice.”
According to employees, the new policy cancelled standard fall flu vaccination events this year and affects every other aspect of the health department’s work, as NPR explained:
“Employees could not send out press releases, give interviews, hold vaccine events, give presentations or create social media posts encouraging the public to get the vaccines. They also could not put up signs at the department’s clinics that COVID, flu or mpox vaccines were available on site.”
“We’re really talking about deaths”
The change comes amid a dangerous swell of anti-vaccine sentiment and misinformation in Louisiana and across the country. President-elect Trump has picked Robert F. Kennedy Jr.—a high-profile anti-vaccine advocate and one of the most prolific spreaders of vaccine misinformation—to head the US Department of Health and Human Services.
In the hearing, board member Jennifer Riebe (who voted to keep COVID-19 vaccinations available) worried about the potential of a slippery slope.
“My concern with this is the process because if this board and six county commissioners and one physician is going to make determinations on every single vaccine and pharmaceutical that we administer, I’m not comfortable with that,” she said, according to Boise State Public Radio. “It may be COVID now, maybe we’ll go down the same road with the measles vaccine or the shingles vaccine coverage.”
Board Chair Kelly Aberasturi, who also voted to keep the vaccines, argued that it should be a choice by individuals and their doctors, who sometimes refer their patients to the district for COVID shots. “So now, you’re telling me that I have the right to override that doctor? Because I know more than he does?” Aberasturi said.
“It has to do with the right of the individual to make that decision on their own. Not for me to dictate to them what they will do. Sorry, but this pisses me off,” he added.
According to Boise State Public Radio, the district had already received 50 COVID-19 vaccines at the time of the vote, which were slated to go to residents of a skilled nursing facility.
The situation in the southwest district may not be surprising given the state’s overall standing on vaccination: Idaho has the lowest kindergarten vaccination rates in the country, with coverage of key vaccinations sitting at around 79 percent to 80 percent, according to a recent analysis by the Centers for Disease Control and Prevention. The coverage is far lower than the 95 percent target set by health experts. That’s the level that would block vaccine-preventable diseases from readily spreading through a population. The target is out of reach for Idaho as a whole, which also has the highest vaccination exemption rate in the country, at 14.3 percent. Even if the state managed to vaccinate all non-exempt children, the coverage rate would only reach 85.7 percent, missing the 95 percent target by nearly 10 percentage points.
Enlarge/ Residents line up for COVID-19 testing on November 30, 2020 in Chicago.
The co-owner of a Chicago-based lab has pleaded guilty for his role in a COVID testing scam that raked in millions—which he used to buy stocks, cryptocurrency, and several luxury cars while still squirreling away over $6 million in his personal bank account.
Zishan Alvi, 45, of Inverness, Illinois, co-owned LabElite, which federal prosecutors say billed the federal government for COVID-19 tests that were either never performed or were performed with purposefully inadequate components to render them futile. Customers who sought testing from LabElite—sometimes for clearance to travel or have contact with vulnerable people—received either no results or results indicating they were negative for the deadly virus.
The scam, which ran from around February 2021 to about February 2022, made over $83 million total in fraudulent payments from the federal government’s Health Resources and Services Administration (HRSA), which covered the cost of COVID-19 testing for people without insurance during the height of the pandemic. Local media coverage indicated that people who sought testing at LabElite were discouraged from providing health insurance information.
The list included five vehicles: a 2021 Mercedes-Benz, a 2021 Land Rover Range Rover HSE, a 2021 Lamborghini Urus, A 2021 Bentley, and a 2022 Tesla X. There was also about $810,000 in an E*Trade account, approximately $500,000 in a Fidelity Investments account, and $245,814 in a Coinbase account. Last, there was $6,825,089 in Alvi’s personal bank account.
On Monday, the Department of Justice announced a deal in which Alvi pleaded guilty to one count of wire fraud, taking responsibility for $14 million worth of fraudulent HRSA claims. He now faces up to 20 years in prison and will be sentenced on February 7, 2025.
Four years after the outbreak of the COVID-19 pandemic, doctors and researchers are still seeking ways to help patients with long COVID, the persistent and often debilitating symptoms that can continue long after a COVID-19 infection.
In adults, the most common long COVID symptoms include fatigue and brain fog, but for children the condition can look different. A study published last month suggests preteens are more likely to experience symptoms such as headaches, stomach pain, trouble sleeping, and attention difficulties. Even among children, effects seem to vary by age. “There seems to be some differences between age groups, with less signs of organ damage in younger children and more adultlike disease in adolescents,” says Petter Brodin, professor of pediatric immunology at Imperial College London.
While vast sums have been devoted to long COVID research—the US National Institutes of Health have spent more than a billion dollars on research projects and clinical trials—research into children with the condition has been predominantly limited to online surveys, calls with parents, and studies of electronic health records. This is in spite of a recent study suggesting that between 10 and 20 percent of children may have developed long COVID following an acute infection, and another report finding that while many have recovered, some still remain ill three years later.
Now, what’s believed to be the first clinical trial specifically aimed at children and young adults with long COVID is underway, recruiting subjects aged 7 to 21 on which to test a potential treatment. It builds on research that suggests long COVID in children may be linked to the gut.
In May 2021, Lael Yonker, a pediatric pulmonologist at Massachusetts General Hospital in Boston, published a study of multisystem inflammatory syndrome in children (MIS-C), which she says is now regarded as a more severe and acute version of long COVID. It showed that these children had elevated levels of a protein called zonulin, a sign of a so-called leaky gut. Higher levels of zonulin are associated with greater permeability in the intestine, which could enable SARS-CoV-2 viral particles to leak out of the intestines and into the bloodstream instead of being excreted out of the body. From there, they could trigger inflammation.
As Yonker began to see more and more children with long COVID, she theorized that many of the gastrointestinal and neurological symptoms they were experiencing might be linked. But her original study also pointed to a possible solution. When she gave the children with MIS-C a drug called larazotide, an existing treatment for people with issues relating to a leaky gut, the levels of viral particles in their blood decreased and their symptoms improved.
Enlarge/ A 13-year-old celebrates getting the Pfizer-BioNTech COVID-19 vaccine in Hartford, Connecticut, on May 13, 2021.
With the impending arrival of the 2024–2025 COVID-19 vaccines approved yesterday, some Americans are now gaming out when to get their dose—right away while the summer wave is peaking, a bit later in the fall to maximize protection for the coming winter wave, or maybe a few weeks before a big family event at the end of the year? Of course, the group pondering such a question is just a small portion of the US.
In a press briefing Friday, federal health officials were quick to redirect focus when reporters raised questions about the timing of COVID-19 vaccination in the coming months and the possibility of updating the vaccines twice a year, instead of just once, to keep up with an evolving virus that has been producing both summer and winter waves.
“The current problem is not that the virus is evolving so much, at least in terms of my estimation,” Peter Marks, the top vaccine regulator at the Food and Drug Administration, told journalists. “It’s that we don’t have the benefits of the vaccine, which is [to say] that it’s not vaccines that prevent disease, it’s vaccination. It’s getting vaccines in arms.” When exactly to get the vaccine is a matter of personal choice, Marks went on, but the most important choice is to get vaccinated.
Estimates for this winter
The press briefing, which featured several federal health officials, was intended to highlight the government’s preparations and hopes for the upcoming respiratory virus season. The FDA, the Centers for Disease Control and Prevention, and the Department of Health and Human Services (HHS) are urging all Americans to get their respiratory virus vaccines—flu, COVID-19, and RSV.
CDC Director Mandy Cohen introduced an updated data site that provides snapshots of local respiratory virus activity, national trends, data visualizations, and the latest guidance in one place. HHS, meanwhile, highlighted a new outreach campaign titled “Risk Less. Do More.” to raise awareness of COVID-19 and encourage vaccination, particularly among high-risk populations. For those not at high risk, health officials still emphasize the importance of vaccination to lower transmission and prevent serious outcomes, including long COVID. “There is no group without risk,” Cohen said, noting that the group with the highest rates of emergency department visits for COVID-19 were children under the age of 5, who are not typically considered high risk.
So far, CDC models are estimating that this year’s winter wave of COVID-19 will be similar, if not slightly weaker on some metrics, than last year’s winter wave, Cohen said. But she emphasized that many assumptions go into the modeling, including how the virus will evolve in the near future and the amount of vaccine uptake. The modeling assumes the current omicron variants stay on their evolutionary path and that US vaccination coverage is about the same as last year. Of course, beating last year’s vaccine coverage could blunt transmission.
As the COVID-19 case count continues to tick upward, the US Food and Drug Administration has approved an updated vaccine for use ahead of the northern hemisphere winter. The emergency use authorization covers updated mRNA vaccines from both Pfizer and Moderna.
The booster shots will target the JN.1 and KP.2 strains of SARS-CoV-2, both of which are omicron variants. Last year’s booster keyed on omicron subvariant XBB.1.5, which has long since lost the evolutionary arms race.
Both Spikevax (Moderna) and Comirnaty (Pfizer) vaccines have been updated. While the vaccine is targeted toward those 12 and over, parents of children aged six months through 11 years are also eligible for the updated vaccines under the FDA’s emergency use authorization.
“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
Updated vaccines will hit hospitals and pharmacies soon, as Moderna and Pfizer are ready to ship vaccines. Once injected, the boosters will take a couple of weeks to hit peak protection, and they will offer that level of protection for a few months after the shot. Keep that in mind as you think about timing your booster for maximum efficacy.
Enlarge/ Long covid activists attend the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies hearing on the “Fiscal Year 2025 Budget Request for the National Institutes of Health,” in Dirksen building on May 23, 2024.
As a summer wave of COVID-19 infections swells once again, a study published this week in the New England Journal of Medicine offers some positive news about the pandemic disease: Rates of long COVID have declined since the beginning of the health crisis, with rates falling from a high of 10.4 percent before vaccines were available to a low of 3.5 percent for those vaccinated during the omicron era, according to the new analysis.
The study, led by Ziyad Al-Aly, chief of research at the VA Saint Louis Health Care System, used data from a wealth of health records in the Department of Veterans Affairs. The researchers ultimately included data from over 440,000 veterans who contracted COVID-19 sometime between March 1, 2020, and January 31, 2022, as well as over 4.7 million uninfected veterans who acted as controls.
Al-Aly and colleagues divided the population into eight groups. People who were infected during the study period were divided into five groupings by the dates of their first infection and their vaccination status. The first group included those infected in the pre-delta era before vaccines were available (March 1, 2020, to June 18, 2021). Then there were vaccinated and unvaccinated groups who were infected in the delta era (June 19, 2021, to December 18, 2021) and the omicron era (December 19, 2021, and January 31, 2022). The uninfected controls made up the final three of eight groups, with the controls assigned to one of the three eras.
On the decline
In the pre-delta/pre-vaccine era, 10.42 out of 100 unvaccinated people infected developed long COVID in the year after their infection, which the researchers referred to as PASC, or postacute sequelae of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. In the delta era, the rate of long COVID among the unvaccinated fell slightly to 9.51 out of 100. But for the vaccinated, the rate fell much further, to 5.35 out of 100. A similar pattern was seen in the omicron era. For the unvaccinated, the rate of long COVID again fell slightly to 7.76 per 100 people, while the vaccinated saw their rate fall to 3.5 per 100.
In a secondary statistical analysis, called a decomposition analysis, the researchers found that vaccines could explain about 72 percent of the cumulative decline in long COVID rates across the eras, while era-related factors explained about 28 percent. Those era-related factors could include differences in the virus, improved treatments, and use of anti-viral medications.
Further, looking at data on the disease categories related to long COVID cases, the researchers also did an analysis finding a shift in symptoms over the eras. The researchers looked at over 10 disease categories: cardiovascular, coagulation and hematologic, fatigue, gastrointestinal, kidney, mental health, metabolic, musculoskeletal, neurologic, and pulmonary. Compared to the two earlier eras, the researchers noted an increase in gastrointestinal, metabolic, and musculoskeletal diseases involved in long COVID cases in the omicron era.
Overall, the study points to a welcomed decline in the rates of long COVID among the infected, particularly for those who are vaccinated. But, it also makes clear that long COVID isn’t a thing of the past: “a substantial residual risk of PASC remains among vaccinated persons who had SARS-CoV-2 infection during the omicron era,” Al-Aly and his colleagues conclude.
The study also has some limitations, leaving lingering questions for further study. One is whether the type or number of vaccines affect the risk of long COVID—that was not included in the study. The study also didn’t allow researchers to assess whether repeat infections increase the burden of long COVID.
On Wednesday, the Supreme Court tossed out claims that the Biden administration coerced social media platforms into censoring users by removing COVID-19 and election-related content.
Complaints alleging that high-ranking government officials were censoring conservatives had previously convinced a lower court to order an injunction limiting the Biden administration’s contacts with platforms. But now that injunction has been overturned, re-opening lines of communication just ahead of the 2024 elections—when officials will once again be closely monitoring the spread of misinformation online targeted at voters.
In a 6–3 vote, the majority ruled that none of the plaintiffs suing—including five social media users and Republican attorneys general in Louisiana and Missouri—had standing. They had alleged that the government had “pressured the platforms to censor their speech in violation of the First Amendment,” demanding an injunction to stop any future censorship.
Plaintiffs may have succeeded if they were instead seeking damages for past harms. But in her opinion, Justice Amy Coney Barrett wrote that partly because the Biden administration seemingly stopped influencing platforms’ content policies in 2022, none of the plaintiffs could show evidence of a “substantial risk that, in the near future, they will suffer an injury that is traceable” to any government official. Thus, they did not seem to face “a real and immediate threat of repeated injury,” Barrett wrote.
“Without proof of an ongoing pressure campaign, it is entirely speculative that the platforms’ future moderation decisions will be attributable, even in part,” to government officials, Barrett wrote, finding that an injunction would do little to prevent future censorship.
Instead, plaintiffs’ claims “depend on the platforms’ actions,” Barrett emphasized, “yet the plaintiffs do not seek to enjoin the platforms from restricting any posts or accounts.”
“It is a bedrock principle that a federal court cannot redress ‘injury that results from the independent action of some third party not before the court,'” Barrett wrote.
Barrett repeatedly noted “weak” arguments raised by plaintiffs, none of which could directly link their specific content removals with the Biden administration’s pressure campaign urging platforms to remove vaccine or election misinformation.
According to Barrett, the lower court initially granting the injunction “glossed over complexities in the evidence,” including the fact that “platforms began to suppress the plaintiffs’ COVID-19 content” before the government pressure campaign began. That’s an issue, Barrett said, because standing to sue “requires a threshold showing that a particular defendant pressured a particular platform to censor a particular topic before that platform suppressed a particular plaintiff’s speech on that topic.”
“While the record reflects that the Government defendants played a role in at least some of the platforms’ moderation choices, the evidence indicates that the platforms had independent incentives to moderate content and often exercised their own judgment,” Barrett wrote.
Barrett was similarly unconvinced by arguments that plaintiffs risk platforms removing future content based on stricter moderation policies that were previously coerced by officials.
“Without evidence of continued pressure from the defendants, the platforms remain free to enforce, or not to enforce, their policies—even those tainted by initial governmental coercion,” Barrett wrote.
Judge: SCOTUS “shirks duty” to defend free speech
Justices Clarence Thomas and Neil Gorsuch joined Samuel Alito in dissenting, arguing that “this is one of the most important free speech cases to reach this Court in years” and that the Supreme Court had an “obligation” to “tackle the free speech issue that the case presents.”
“The Court, however, shirks that duty and thus permits the successful campaign of coercion in this case to stand as an attractive model for future officials who want to control what the people say, hear, and think,” Alito wrote.
Alito argued that the evidence showed that while “downright dangerous” speech was suppressed, so was “valuable speech.” He agreed with the lower court that “a far-reaching and widespread censorship campaign” had been “conducted by high-ranking federal officials against Americans who expressed certain disfavored views about COVID-19 on social media.”
“For months, high-ranking Government officials placed unrelenting pressure on Facebook to suppress Americans’ free speech,” Alito wrote. “Because the Court unjustifiably refuses to address this serious threat to the First Amendment, I respectfully dissent.”
At least one plaintiff who opposed masking and vaccines, Jill Hines, was “indisputably injured,” Alito wrote, arguing that evidence showed that she was censored more frequently after officials pressured Facebook into changing their policies.
“Top federal officials continuously and persistently hectored Facebook to crack down on what the officials saw as unhelpful social media posts, including not only posts that they thought were false or misleading but also stories that they did not claim to be literally false but nevertheless wanted obscured,” Alito wrote.
While Barrett and the majority found that platforms were more likely responsible for injury, Alito disagreed, writing that with the threat of antitrust probes or Section 230 amendments, Facebook acted like “a subservient entity determined to stay in the good graces of a powerful taskmaster.”
Alito wrote that the majority was “applying a new and heightened standard” by requiring plaintiffs to “untangle Government-caused censorship from censorship that Facebook might have undertaken anyway.” In his view, it was enough that Hines showed that “one predictable effect of the officials’ action was that Facebook would modify its censorship policies in a way that affected her.”
“When the White House pressured Facebook to amend some of the policies related to speech in which Hines engaged, those amendments necessarily impacted some of Facebook’s censorship decisions,” Alito wrote. “Nothing more is needed. What the Court seems to want are a series of ironclad links.”
Enlarge/ Microbiologist Didier Raoult addresses a press conference on COVID-19 at the IHU medical institute in Marseille on April 20, 2022.
A scientific journal published by Elsevier has reportedly posted a stunning 101 expressions of concern on studies connected to Didier Raoult, a disgraced French microbiologist who gained international prominence amid the pandemic by promoting, with little evidence, that the malaria drug hydroxychloroquine could treat COVID-19—a claim that has now been firmly debunked.
According to Retraction Watch, the journal New Microbes and New Infections posted 101 expressions of concern on Raoult’s works recently, including a 2023 study that drew sharp criticism. The study involved giving hydroxychloroquine to tens of thousands of COVID-19 patients after data indicated that it wasn’t effective and the French government rescinded permission for its use against COVID-19. An op-ed in the major French newspaper Le Monde described the study as “the largest ‘wild’ therapeutic trial known to date.”
The expressions of concern also come as Raoult saw his tenth study retracted, Retraction Watch noted.
While Raoult’s unfounded claims about hydroxychloroquine drew initial attention to his COVID-19-related work—with critics quickly noting flaws and weaknesses in his studies—his high-profile claims led critics and sleuths to dive deeper into his extensive publication record. There, they claim they found evidence of long-standing and egregious ethics violations, which were recently laid out in an investigative report by Science Magazine.
Essentially, critics claim Raoult and the institute that he led until 2021, the Hospital Institute of Marseille Mediterranean Infection (IHU), conducted hundreds of studies on humans without appropriate ethical approval or oversight or adequate consent from all participants, the Science investigation found. The IHU work spanned a wide variety of research topics, which involved collecting a variety of biological samples from patients, including vaginal swabs, feces, blood, urine, and breast milk.
However, critics noted 248 IHU studies that reused the same ethical approval code, “09-022,” despite being very different studies that included different kinds of sampling. The critics claim that the studies required separate ethical approvals and additional oversight. They also found that at least 17 studies relied on vulnerable populations, including refugees and people living in homeless shelters, raising serious questions about consent. Some of the studies were also conducted in African countries, where evidence of local ethical approval was either absent or incomplete.
Raoult told the magazine that his research groups had the appropriate ethical approval and said that his critics, whom he described as stalkers and cyber harassers, did not understand how French biomedical laws work.
In Elsevier’s expressions of concern and a linked “Publisher’s Note” from November, the publisher said that the concern was over “the articles’ adherence to Elsevier’s publishing ethics policies and the appropriate conduct of research involving human participants.” Elsevier is still investigating the matter but indicated that the expressions of concern are added “if it is deemed that there is a particular need to alert readers to serious concerns while [the] investigation is ongoing.”
Raoult has had nearly 50 studies likewise flagged over ethical concerns in PLOS journals, Retraction Watch noted. The latest of his studies to be retracted was in the journal Scientific Reports, with the editors there also stating it was due to a lack of ethical oversight. “The paper cites approval from an institutional ethics committee in France, but samples used in this study were also sourced from Algeria, Saudi Arabia, and Niger,” the retraction notice says. “The Authors were not able to provide documentation of approval from ethics committees in these countries or of compliance with local regulations regarding the use of such samples in research.”
Raoult is currently under criminal investigation in France.
