health – Page 2

Widely panned arsenic life paper gets retracted—15 years after brouhaha

arsenic, health, journal, Science, science journalism / Beth Washington / July 26, 2025

In all, the astronomic hype was met with earth-shaking backlash in 2010 and 2011. In 2012, Science published two studies refuting the claim that GFAJ-1 incorporates arsenic atoms into its DNA. Outside scientists concluded that it is an arsenic-tolerant extremophile, but not a profoundly different life form.

Retraction

But now, in 2025, it is once again spurring controversy; on Thursday, Science announced that it is retracting the study.

Some critics, such as Redfield, cheered the move. Others questioned the timing, noting that 15 years had passed, but only a few months had gone by since The New York Times published a profile of Wolfe-Simon, who is now returning to science after being perceived as a pariah. Wolfe-Simon and most of her co-authors, meanwhile, continue to defend the original paper and protest the retraction.

In a blog post on Thursday, Science’s executive editor, Valda Vinson, and Editor-in-Chief Holden Thorp explained the retraction by saying that Science’s criteria for issuing a retraction have evolved since 2010. At the time, it was reserved for claims of misconduct or fraud but now can include serious flaws. Specifically, Vinson and Thorp referenced the criticism that the bacterium’s genetic material was not properly purified of background arsenic before it was analyzed. While emphasizing that there has been no suggestion of fraud or misconduct on the part of the authors, they wrote that “Science believes that the key conclusion of the paper is based on flawed data,” and it should therefore be retracted.

Jonathan Eisen, an evolutionary biologist at the University of California, Davis, criticized the move. Speaking with Science’s news team, which is independent from the journal’s research-publishing arm, Eisen said that despite being a critic of the 2010 paper, he thought the discussion of controversial studies should play out in the scientific literature and not rely on subjective decisions by editors.

In an eLetter attached to the retraction notice, the authors dispute the retraction, too, saying, “While our work could have been written and discussed more carefully, we stand by the data as reported. These data were peer-reviewed, openly debated in the literature, and stimulated productive research.”

One of the co-authors, Ariel Anbar, a geochemist at Arizona State University, told Nature that the study had no mistakes but that the data could be interpreted in different ways. “You don’t retract because of a dispute about data interpretation,” he said. If that were the case, “you’d have to retract half the literature.”

Widely panned arsenic life paper gets retracted—15 years after brouhaha Read More »

Inventor claims bleach injections will destroy cancer tumors

bleach, health, quackery, syndication / Beth Washington / July 25, 2025

A lack of medical training isn’t stopping a man from charging $20,000 for the treatment.

Credit: Aurich Lawson | Getty Images

Xuewu Liu, a Chinese inventor who has no medical training or credentials of any kind, is charging cancer patients $20,000 for access to an AI-driven but entirely unproven treatment that includes injecting a highly concentrated dose of chlorine dioxide, a toxic bleach solution, directly into cancerous tumors.

One patient tells WIRED her tumor has grown faster since the procedure and that she suspects it may have caused her cancer to spread—a claim Liu disputes—while experts allege his marketing of the treatment has likely put him on the wrong side of US regulations. Nonetheless, while Liu currently only offers the treatment informally in China and at a German clinic, he is now working with a Texas-based former pharmaceutical executive to bring his treatment to America. They believe that the appointment of Robert F. Kennedy Jr. as US health secretary will help “open doors” to get the untested treatment—in which at least one clinic in California appears to have interest—approved in the US.

Kennedy’s Make America Healthy Again movement is embracing alternative medicines and the idea of giving patients the freedom to try unproven treatments. While the health secretary did not respond to a request for comment about Liu’s treatment, he did mention chlorine dioxide when questioned about President Donald Trump’s Operation Warp Speed during his Senate confirmation hearing in February, and the Food and Drug Administration recently removed a warning about the substance from its website. The agency says the removal was part of a routine process of archiving old pages on its site, but it has had the effect of emboldening the bleacher community.

“Without the FDA’s heavy-handed warnings, it’s likely my therapy would have been accepted for trials years earlier, with institutional partnerships and investor support,” Liu tells WIRED. He says he wrote to Kennedy earlier this year urging him to conduct more research on chlorine dioxide. “This quiet removal won’t immediately change everything, but it opens a door. If mainstream media reports on this shift, I believe it will unlock a new wave of serious [chlorine dioxide] research.”

For decades, pseudoscience grifters have peddled chlorine dioxide solutions—sold under a variety of names, such as Miracle Mineral Solution—and despite warnings and prosecutions have continued to claim the toxic substance is a “cure” for everything from HIV to COVID-19 to autism. There is no credible evidence to back up any of these claims, which critics have long labeled as nothing more than a grift.

The treatments typically involve drinking liquid chlorine dioxide on a regular basis, using solutions with concentrations of chlorine dioxide of around 3,000 parts per million (ppm), which is diluted further in water.

Liu’s treatment, however, involves a much higher concentration of chlorine dioxide—injections of several millilitres of 20,000 ppm—and, rather than drinking it, patients have it injected directly into their tumors.

I injected myself to test it

Liu claims he has injected himself with the solution more than 50 times and suffered no side effects. “This personal data point encouraged me to continue research,” he says.

Liu has been making the solution in his rented apartment in Beijing by mixing citric acid with sodium chlorite, according to an account he shared earlier this month on his Substack that revealed that a “violent explosion” occurred when he made a mistake.

“The blast blacked out my vision,” Liu wrote. “Dense clouds of chlorine dioxide burst into my face, filling my eyes, nose, and mouth. I stumbled back into the apartment, rushing to the bathroom to wash out the gas from my eyes and respiratory tract. My lungs were burning. Later, I would find 4–5 cuts on my upper thigh—shards of glass had pierced through my pants.” Liu also revealed that his 3-year-old daughter was nearby when the explosion happened.

Liu began a preclinical study on animals in 2016, before beginning to use the highly concentrated solution to treat human patients in more recent years. He claims that between China and Germany, he has treated 20 patients to date.

When asked for evidence to back up his claims of efficacy, Liu shared links to a number of preprints, which have not been peer-reviewed, with WIRED. He also shared a pitch deck for a $5 million seed round in a US-focused startup that would provide the chlorine dioxide injections.

The presentation contains a number of “case studies” of patients he has treated—including a dog—but rather than featuring detailed scientific data, the deck contains disturbing images of the patients’ tumors. The deck also contains, as evidence of the treatment’s efficacy, a screenshot of a WhatsApp conversation with a patient who was apparently treating a liver tumor with chlorine dioxide.

“Screenshots of WhatsApp chats with patients or their doctors is not evidence of efficacy, yet that is the only evidence he provides,” says Alex Morozov, an oncologist who has overseen hundreds of drug trials at multiple companies including Pfizer. “Needless to say, until appropriate studies are done and published in peer-reviewed journals, or presented at a reputable conference, no patients should be treated except in the context of clinical trials.”

WIRED spoke to a patient of Liu’s, whose descriptions of the treatment appear to undermine his claims of efficacy and raise serious questions about its safety.

“I bought the needles online and made the chlorine dioxide by myself [then] I injected it into the tumor and lymph nodes by myself,” says the patient, a Chinese national living in the UK. WIRED granted her anonymity to protect her privacy.

The patient had previously been taking oral solutions of chlorine dioxide as an alternative treatment for cancer, but, unsatisfied with the results, she contacted Liu via WhatsApp. On a spring evening last year, she took her first injection of chlorine dioxide and, she says, almost immediately suffered negative side effects.

“It was fine after the injection, but I was woken up by severe pain [like] I had never experienced in my life,” she says. “The pain lasted for three to four days.”

Despite the pain, she says, she injected herself again two months later, and a month after that she traveled to China, where Liu, despite having no medical training, injected her, using an anesthetic cream to numb the skin.

“While this act technically fell outside legal boundaries, in China, if the patient is competent and gives informed consent, such compassionate-use interventions rarely attract regulatory attention unless harm is done,” Liu tells WIRED.

Legal in China?

Experts on Chinese medical regulations tell WIRED that new treatments like Liu’s would have to meet strict conditions before they can be administered to patients. “It would have to go through the same steps in China as it does in the US, so that will involve clinical studies, getting ethics approval at the hospitals, and then the situation would have to be reviewed by the Chinese government,” Ames Gross, founder and president of Pacific Bridge Capital, tells WIRED. “I don’t think any of it sounds very legal.” The Chinese Ministry of Foreign Affairs, which handles all international press inquiries, did not respond to a request for comment.

As well as the initial pain, the chlorine dioxide injections also appear, the patient says, to have made the cancer worse.

“The tumor shrinks first, then it grows faster than before,” she says, adding: “My tumor has spread to the skin after injection. I suspect it is because the chlorine dioxide has broken the vein and the cancer cells go to the skin area.”

Liu did not agree with this assessment, instead blaming the fact that the patient had not completed the full course of four injections within a month, as he typically prescribes.

The patient says that thanks to a WeChat group that Liu set up, she is also in contact with other people who have had chlorine dioxide injections. One of the women, who is based in Shenzhen, China, had at least one injection of chlorine dioxide to treat what was described as vaginal cancer, but she says she is also suffering complications, according to screenshots of conversations reviewed by WIRED.

“After the injection, there was swelling and difficulty urinating,” the Chinese woman wrote. “It was very uncomfortable.”

Despite having injected a patient in China last August, Liu tells WIRED, he is not a licensed physician—he calls himself “an independent inventor and medical researcher.” The treatment, which he says is “designed to be administered by licensed physicians in clinical settings,” is so painful that it needs to be given under general anesthetic.

While Liu’s website says the treatment is being offered at clinics in Mexico, Brazil, and the Philippines, he tells WIRED that the treatment is currently only being offered at the CMC Rheinfelden clinic on the German-Swiss border. Liu features Dr. Wolfgang Renz from the clinic on his own website as one of his partners; the clinic itself does not advertise the treatment on its own website.

In conversations on WhatsApp shared with WIRED, a representative of the clinic named Lena told a prospective patient that it didn’t advertise the chlorine dioxide procedure because it was “not a legal treatment.” Lena later wrote that chlorine dioxide was not referenced on an invoice the clinic sent the same prospective patient because it is “not a legal treatment.” Lena also told the prospective patient that they had treated patients from France, Italy, and the US, according to a recording of a phone call shared with WIRED. One Italian woman is currently trying to raise money to fund her treatment in the German clinic on GoFundMe.

When asked about her comments, Lena told WIRED, “Either [the patient] misquoted me or my English was not very accurate. I repeatedly told [the patient] that it is not an approved therapy and therefore requires very detailed consent and special circumstances to be eligible for this treatment.” The prospective patient was told that she would need to bring documents detailing her prior treatment.

Renz did not respond to multiple requests for comment.

Lena also says that patients who have exhausted every other possible treatment have “the right to be treated with non-approved interventions under strict ethical conditions, full medical supervision, and informed patient consent.” The Federal Institute for Drugs and Medical Devices, which regulates medical products in Germany, did not respond to a request for comment, but Liu tells WIRED that German authorities are investigating a complaint about the clinic.

Expanding across the Pacific

Liu now appears laser-focused on making his treatment available in the US. Despite the lack of clinical data to back up his claims, Liu claims to have signed up over 100 US patients to take part in a proposed clinical research program. Liu shared a screenshot with WIRED including what appeared to be patients’ full names, zip codes, and the type of cancer they are suffering from. It’s unclear if any of the patients had agreed to have their information shared with a journalist.

Liu says he has recruited most of his potential patients via his own website. “Are You a U.S. Cancer Patient? Join the National Campaign to legalize a breakthrough therapy,” a popup that sometimes appears on Liu’s website reads, urging visitors to fill out a patient advocacy application to potentially become part of a clinical trial.

One of those who signed up is Sarah Jones, who has been diagnosed with stage 4 anal cancer that has metastasized to the lymph nodes. Jones, whose identity WIRED is protecting with a pseudonym, has already been treated with chemotherapy and drugs like cisplatin and paclitaxel. The chemotherapy originally caused the tumor to shrink, but it has since returned, and Jones is now seeking alternative treatments.

“I spend my days treating this disease like a job. Red light therapy, guided meditations, exercising, eating a keto-strong diet, and researching,” Jones tells WIRED. “This is how I stumbled upon Liu and his intratumoral injections.”

Despite signing up for a potential trial, Jones understands the risks but feels as if she is running out of choices. “I am extremely concerned that there are but a handful of patients and no data to speak of for this procedure,” Jones says. “I am debating all of my options and am constantly looking for anything that can help.”

This sentiment was echoed by Kevin, whose father has neck cancer and who also signed up as a potential patient for the trial. “If you’re in any cancer patient’s shoes, if you’re out of options, what else do you have to do? You either keep trying new therapies, or you die.”

Another US-based patient with untreated colon cancer who signed up on Liu’s website was informed that they should consider traveling to Germany for treatment, according to a screenshot of an email response from Liu, shared with WIRED. The email outlined that the cost would be €5,000 per injection, adding that “typically 4 injections [are] recommended.”

When the conversation moved to WhatsApp, Liu asked the patient what size the tumor was. The patient, who was granted anonymity to protect their privacy, told Liu the tumor was 3.8 centimeters, according to a screenshot of the WhatsApp conversation reviewed by WIRED.

Liu responded with inaccurate details and information that the patient did not share. Liu also referred to a rectal tumor rather than a colon tumor.

When the patient said they didn’t have the money to travel to Europe for the treatment and asked about getting it in the US, referencing the Williams Cancer Institute in Beverly Hills, California, Liu suggested contacting the clinic directly.

The clinic has indicated its interest in Liu’s unproven procedure by writing about Liu’s chlorine dioxide injection protocol on its own website and mentioned it on a post on its Facebook page. Liu tells WIRED that he has spoken to Jason Williams, director of the clinic. “He is very interested and is a pioneer in the field of intratumoral injections,” Liu says. “His clinic is fully capable of implementing my therapy.”

Neither Williams nor his colleague Nathan Goodyear, who Liu also says he spoke to, responded to repeated emails and phone calls seeking comment.

Liu also gave WIRED the names of a radiologist in California, an anesthesiologist in Seattle, and a physician in Missouri who he claims to have spoken to about providing his treatment in the US, but none of them responded to requests for comment.

The Chinese inventor did, however, appear on a livestream with two US-based doctors, Curtis Anderson, a Florida-based physician, and Mark Rosenberg, who works at the Institute for Healthy Aging. The discussion, hosted on Liu’s YouTube channel, saw the two doctors ask about which cancers to treat with the injections, how to buy chlorine dioxide, or even whether it’s possible to make it themselves.

Rosenberg and Anderson did not respond to requests for comment.

Maybe RFK Jr. will dig it?

Conducting a clinical trial of a new drug in the US requires approval from the Food and Drug Administration. Liu initially claimed to WIRED that “according to Article 37 of the Declaration of Helsinki and the US Right to Try laws, my therapy is already legally permissible in the United States.” Legal experts WIRED spoke to disagree strongly with Liu’s assertions.

“It sounds like Mr. Liu may not understand how the Right to Try Act or the Declaration of Helsinki work or how they fit within the broader context in which the FDA regulates investigational drugs,” Clint Hermes, an attorney with Bass, Berry & Sims, with extensive expertise in biomedical research, tells WIRED. “If he is under the impression that the ‘breast cancer trial’ referenced on his website is sufficient on its own to allow him to market or study his therapy in the US under right to try and/or the Declaration of Helsinki, he is mistaken.”

Even advertising the efficacy of an unproven treatment could land Liu in trouble, according to the American Health Law Association (AHLA).

“Companies cannot make claims regarding safety or efficacy until their products have been approved for marketing by the FDA,” Mary Kohler, a member of the AHLA’s Life Science leadership team, tells WIRED. “From a quick glance at the website, I see several claims that FDA’s Office of Prescription Drug Promotion (OPDP) would likely consider violative as pre-approval promotion even if this company were in trials that FDA was overseeing.”

The FDA and the Department of Health and Human Services did not respond to requests for comment.

When asked about these issues, Liu clarified that he was planning to initially conduct a 100-person “clinical research program” that would not require FDA approval, but Liu’s treatment doesn’t appear to meet any of the most common exemptions that would allow such a trial to take place, according to the FDA’s own website.

Liu also says he is working with “patient advocates” and leveraging their local connections to lobby state lawmakers in “liberty-leaning states” to allow the experimental treatment to be administered. This would appear to circumvent federal rules. Liu says that he has yet to make contact with such a lawmaker directly.

While he has no approval from US government agencies or support of a state or national lawmaker, Liu does have the full backing of Scott Hagerman, an entrepreneur and former executive with 30 years experience in the pharmaceutical industry, including a decade working at Pfizer.

“It’s an unbelievable breakthrough,” Hagerman tells WIRED, adding that he and his wife have been using oral chlorine dioxide solution “for some time” as a preventative measure rather than to treat a specific ailment.

Hagerman’s time in the pharmaceutical industry included over a decade running a company called Chemi Nutra, which has in the past received a US patent for a soy-based supplement that addresses testosterone decline in men. He also says he oversaw teams of scientists who worked on drug applications to the FDA for oncology drugs.

Hagerman retired from Chemi Nutra in 2021, and in the intervening years his comments indicate that he appears to have become entirely disillusioned with the modern pharmaceutical industry, referring to it as a “drugs cartel” and “a corrupt entity that is only profit-driven.” One of the issues Hagerman references is the COVID-19 vaccine based on mRNA technology, which he describes as a “con job” while also boosting the debunked theory that childhood vaccines are linked to increasing levels of autism reported in the population.

As a result, he sees Liu’s lack of experience as a positive.

“I would welcome the fact that he’s not a doctor, that he’s not an MD, because he’s not clouded, jaded, and biased with all kinds of misguidance that would push them the wrong way,” Hagerman says, adding, “I’d like to help him establish some network here in the US, because obviously the US is where the action is.” Hagerman says he is “100 percent sure” that there would be investors willing to fund the development of this treatment.

When asked about a timeline to have this procedure legally available in the US, Hagerman said he hopes it could be achieved before the end of 2025. Liu, however, thinks it could take slightly longer, saying that he believes clinical trials will begin in 2026.

This story originally appeared on wired.com.

Wired.com is your essential daily guide to what’s next, delivering the most original and complete take you’ll find anywhere on innovation’s impact on technology, science, business and culture.

Inventor claims bleach injections will destroy cancer tumors Read More »

Anti-vaccine group founded by RFK Jr. sues RFK Jr. over vaccine task force

CDC, children's health defense, health, HHS, Robert F. Kennedy, vaccines / 9u50fv / July 24, 2025

Now that Kennedy has moved on to politics, stepping down from his role at Children’s Health Defense (CHD) and joining the Trump administration, CHD has not let go of the issue.

Ray Flores, senior outside counsel to CHD, filed the lawsuit, which is being funded by CHD. In it, Flores notes that on March 15, 2025, he sent Kennedy a 60-day notice about the task force issue, and Kennedy did not respond.

Overall, the lawsuit contains anti-vaccine talking points and false claims, such as that childhood vaccines have not gone through safety testing (they have). Flores justifies the lawsuit saying that, without the task force, he “and his family can’t make informed decisions in light of the onslaught of current and seemingly never-ending outbreaks.”

In a social media post from CHD on Tuesday, Flores criticized Kennedy directly. “Why is he not dealing with vaccines? This is not the Bobby we know,” he said in the posted video. “Is he being held captive in the swamp? And it kind of feels that way sometimes, doesn’t it?”

It remains unclear why Kennedy has not set up the task force. HHS did not immediately respond to a request for comment from Ars Technica.

Otherwise, Kennedy has not shied from unilaterally rolling back access to vaccines and continuing to spread anti-vaccine misinformation as the country’s top health official. His hand-selected vaccine advisory committee has already announced its intention to question the entire childhood vaccine schedule.

Potential explanations

However, there is one clear detail that could potentially explain Kennedy’s delay. The 1986 law that sets up the task force is specific about who should be on it. The task force “shall consist of the Director of the National Institutes of Health, the Commissioner of the Food and Drug Administration, and the Director of the Centers for Disease Control [and Prevention],” the law reads. Currently, the CDC has no director.

Anti-vaccine group founded by RFK Jr. sues RFK Jr. over vaccine task force Read More »

RFK Jr. wants to change program that stopped vaccine makers from leaving US market

anti-vaccines, CDC, health, rfk jr, robert f kennedy jr, syndication, vaccines / Mike M. / July 19, 2025

RFK Jr. is targeting a little-known program that underpins childhood immunizations in the US.

US Secretary of Health and Human Services Robert F. Kennedy Jr. testifies before the Senate Committee on Health, Education, Labor, and Pensions on Capitol Hill on May 20, 2025 in Washington, DC. Credit: Getty | Tasos Katopodis

This story was originally published by ProPublica.

Five months after taking over the federal agency responsible for the health of all Americans, Robert F. Kennedy Jr. wants to overhaul an obscure but vital program that underpins the nation’s childhood immunization system.

Depending on what he does, the results could be catastrophic.

In his crosshairs is the Vaccine Injury Compensation Program, a system designed to provide fair and quick payouts for people who suffer rare but serious side effects from shots—without having to prove that drugmakers were negligent. Congress created the program in the 1980s when lawsuits drove vaccine makers from the market. A special tax on immunizations funds the awards, and manufacturers benefit from legal protections that make it harder to win big-money verdicts against them in civil courts.

Kennedy, who founded an anti-vaccination group and previously accused the pharmaceutical industry of inflicting “unnecessary and risky vaccines” on children for profits, has long argued that the program removes any incentive for the industry to make safe products.

In a recent interview with Tucker Carlson, Kennedy condemned what he called corruption in the program and said he had assigned a team to overhaul it and expand who could seek compensation. He didn’t detail his plans but did repeat the long-debunked claim that vaccines cause autism and suggested, without citing any evidence, that shots could also be responsible for a litany of chronic ailments, from diabetes to narcolepsy.

There are a number of ways he could blow up the program and prompt vaccine makers to stop selling shots in the US, like they did in the 1980s. The trust fund that pays awards, for instance, could run out of money if the government made it easy for Kennedy’s laundry list of common health problems to qualify for payments from the fund.

Or he could pick away at the program one shot at a time. Right now, immunizations routinely recommended for children or pregnant women are covered by the program. Kennedy has the power to drop vaccines from the list, a move that would open up their manufacturers to the kinds of lawsuits that made them flee years ago.

Dr. Eddy Bresnitz, who served as New Jersey’s state epidemiologist and then spent a dozen years as a vaccine executive at Merck, is among those worried.

“If his unstated goal is to basically destroy the vaccine industry, that could do it,” said Bresnitz, who retired from Merck and has consulted for vaccine manufacturers. “I still believe, having worked in the industry, that they care about protecting American health, but they are also for-profit companies with shareholders, and anything that detracts from the bottom line that can be avoided, they will avoid.”

A spokesperson for PhRMA, a US trade group for pharmaceutical companies, told ProPublica in a written statement that upending the Vaccine Injury Compensation Program “would threaten continued patient access to FDA-approved vaccines.”

The spokesperson, Andrew Powaleny, said the program “has compensated thousands of claims while helping ensure the continued availability of a safe and effective vaccine supply. It remains a vital safeguard for public health and importantly doesn’t shield manufacturers from liability.”

Since its inception, the compensation fund has paid about $4.8 billion in awards for harm from serious side effects, such as life-threatening allergic reactions and Guillain-Barré syndrome, an autoimmune condition that can cause paralysis. The federal agency that oversees the program found that for every 1 million doses of vaccine distributed between 2006 and 2023, about one person was compensated for an injury.

Since becoming Health and Human Services secretary, Kennedy has turned the staid world of immunizations on its ear. He reneged on the US government’s pledge to fund vaccinations for the world’s poorest kids. He fired every member of the federal advisory group that recommends which shots Americans get, and his new slate vowed to scrutinize the US childhood immunization schedule. Measles, a vaccine-preventable disease eliminated here in 2000, roared back and hit a grim record—more cases than the US has seen in 33 years, including three deaths. When a US senator asked Kennedy if he recommended measles shots, Kennedy answered, “Senator, if I advised you to swim in a lake that I knew there to be alligators in, wouldn’t you want me to tell you there were alligators in it?”

Fed up, the American Academy of Pediatrics and other medical societies sued Kennedy last week, accusing him of dismantling “the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans.” (The federal government has yet to respond to the suit.)

Just about all drugs have side effects. What’s unusual about vaccines is that they’re given to healthy people—even newborns on their first day of life. And many shots protect not just the individuals receiving them but also the broader community by making it harder for deadly scourges to spread. The Centers for Disease Control and Prevention estimates that routine childhood immunizations have prevented more than 1.1 million deaths and 32 million hospitalizations among the generation of Americans born between 1994 and 2023.

To most people, the nation’s vaccine system feels like a solid, reliable fact of life, doling out shots to children like clockwork. But in reality it is surprisingly fragile.

There are only a handful of companies that make nearly all of the shots children receive. Only one manufacturer makes chickenpox vaccines. And just two or three make the shots that protect against more than a dozen diseases, including polio and measles. If any were to drop out, the country could find itself in the same crisis that led President Ronald Reagan to sign the law creating the Vaccine Injury Compensation Program in 1986.

Back then, pharmaceutical companies faced hundreds of lawsuits alleging that the vaccine protecting kids from whooping cough, diphtheria, and tetanus caused unrelenting seizures that led to severe disabilities. (Today’s version of this shot is different.) One vaccine maker after another left the US market.

At one point, pediatricians could only buy whooping cough vaccines from a single company. Shortages were so bad that the CDC recommended doctors stop giving booster shots to preserve supplies for the most vulnerable babies.

While Congress debated what to do, public health clinics’ cost per dose jumped 5,000 percent in five years.

“We were really concerned that we would lose all vaccines, and we would get major resurgences of vaccine-preventable diseases,” recalled Dr. Walter Orenstein, a vaccine expert who worked in the CDC’s immunization division at the time.

A Forbes headline captured the anxiety of parents, pediatricians, and public health workers: “Scared Shotless.” So a bipartisan group in Congress hammered out the no-fault system.

Today, the program covers vaccines routinely recommended for children or pregnant women once Congress approves the special tax that funds awards. (COVID-19 shots are part of a separate, often-maligned system for handling claims of harm, though Kennedy has said he’s looking at ways to add them to the Vaccine Injury Compensation Program.)

Under program rules, people who say they are harmed by covered vaccines can’t head straight to civil court to sue manufacturers. First, they have to go through the no-fault system. The law established a table of injuries and the time frame for when those conditions must have appeared in order to be considered for quicker payouts. A tax on those vaccines — now 75 cents for every disease that a shot protects against — flows into a trust fund that pays those approved for awards. Win or lose, the program, for the most part, pays attorney fees and forbids lawyers from taking a cut of the money paid to the injured.

The law set up a dedicated vaccine court where government officials known as special masters, who operate like judges, rule on cases without juries. People can ask for compensation for health problems not listed on the injury table, and they don’t have to prove that the vaccine maker was negligent or failed to warn them about the medical condition they wound up with. At the same time, they can’t claim punitive damages, which drive up payouts in civil courts, and pain and suffering payments are capped at $250,000.

Plaintiffs who aren’t satisfied with the outcome or whose cases drag on too long can exit the program and file their cases in traditional civil courts. There they can pursue punitive damages, contingency-fee agreements with lawyers and the usual evidence gathering that plaintiffs use to hold companies accountable for wrongdoing.

But a Supreme Court ruling, interpreting the law that created the Vaccine Injury Compensation Program, limited the kinds of claims that can prevail in civil court. So while the program isn’t a full liability shield for vaccine makers, its very existence significantly narrows the cases trial lawyers can file.

Kennedy has been involved in such civil litigation. In his federal disclosures, he revealed that he referred plaintiffs to a law firm filing cases against Merck over its HPV shot in exchange for a 10 percent cut of the fees if they win. After a heated exchange with Sen. Elizabeth Warren during his confirmation proceedings, Kennedy said his share of any money from those cases would instead go to one of his adult sons, who he later said is a lawyer in California. His son Conor works as an attorney at the Los Angeles law firm benefiting from his referrals. When ProPublica asked about this arrangement, Conor Kennedy wrote, “I don’t work on those cases and I’m not receiving any money from them.”

In March, a North Carolina federal judge overseeing hundreds of cases that alleged Merck failed to warn patients about serious side effects from its HPV vaccine ruled in favor of Merck; an appeal is pending.

The Vaccine Injury Compensation Program succeeded in stabilizing the business of childhood vaccines, with many more shots developed and approved in the decades since it was established. But even ardent supporters acknowledge there are problems. The program’s staff levels haven’t kept up with the caseload. The law capped the number of special masters at eight, and congressional bills to increase that have failed. An influx of adult claims swamped the system after adverse reactions to flu shots became eligible for compensation in 2005 and serious shoulder problems were added to the injury table in 2017.

The quick and smooth system of payouts originally envisioned has evolved into a more adversarial one with lawyers for the Department of Justice duking it out with plaintiffs’ attorneys, which Kennedy says runs counter to the program’s intent. Many cases drag on for years.

In his recent interview with Carlson, he described “the lawyers of the Department of Justice, the leaders of it” working on the cases as corrupt. “They saw their job as protecting the trust fund rather than taking care of people who made this national sacrifice, and we’re going to change all that,” he said. “And I’ve brought in a team this week that is starting to work on that.”

The system is “supposed to be generous and fast and gives a tie to the runner,” he told Carlson. “In other words, if there’s doubts about, you know, whether somebody’s injury came from a vaccine or not, you’re going to assume they got it and compensate them.”

Kennedy didn’t identify who is on the team reviewing the program. At one point in the interview, he said, “We just brought a guy in this week who’s going to be revolutionizing the Vaccine Injury Compensation Program.”

The HHS employee directory now lists Andrew Downing as a counselor working in Kennedy’s office. Downing for many years has filed claims with the program and suits in civil courts on behalf of clients alleging harm from shots. Last month, HHS awarded a contract for “Vaccine Injury Compensation Program expertise” to Downing’s firm, as NOTUS has reported.

Downing did not respond to a voicemail left at his law office. HHS didn’t reply to a request to make him and Kennedy available for an interview and declined to answer detailed questions about its plans for the Vaccine Injury Compensation Program. In the past, an HHS spokesperson has said that Kennedy is “not anti-vaccine—he is pro-safety.”

While it’s not clear what changes Downing and Kennedy have in mind, Kennedy’s interview with Carlson offered some insights. Kennedy said he was working to expand the program’s three-year statute of limitations so that more people can be compensated. Downing has complained that patients who have certain autoimmune disorders don’t realize their ailments were caused by a vaccine until it’s too late to file. Congress would have to change the law to allow this, experts said.

A key issue is whether Kennedy will try to add new ailments to the list of injuries that qualify for quicker awards.

In the Carlson interview, Kennedy dismissed the many studies and scientific consensus that shots don’t cause autism as nothing more than statistical trickery. “We’re going to do real science,” Kennedy said.

The vaccine court spent years in the 2000s trying cases that alleged autism was caused by the vaccine ingredient thimerosal and the shot that protects people from measles, mumps, and rubella. Facing more than 5,000 claims, the court asked a committee of attorneys representing children with autism to pick test cases that represented themes common in the broader group. In the cases that went to trial, the special masters considered more than 900 medical articles and heard testimony from dozens of experts. In each of those cases, the special masters found that the shots didn’t cause autism.

In at least two subsequent cases, children with autism were granted compensation because they met the criteria listed in the program’s injury table, according to a vaccine court decision. That table, for instance, lists certain forms of encephalopathy—a type of brain dysfunction—as a rare side effect of shots that protect people from whooping cough, measles, mumps, and rubella. In a 2016 vaccine court ruling, Special Master George L. Hastings Jr. explained, “The compensation of these two cases, thus does not afford any support to the notion that vaccinations can contribute to the causation of autism.”

Hastings noted that when Congress set up the injury table, the lawmakers acknowledged that people would get compensated for “some injuries that were not, in fact, truly vaccine-caused.”

Many disabling neurological disorders in children become apparent around the time kids get their shots. Figuring out whether the timing was coincidental or an indication that the vaccines caused the problem has been a huge challenge.

Devastating seizures in young children were the impetus for the compensation program. But in the mid-1990s, after a yearslong review of the evidence, HHS removed seizure disorder from the injury table and narrowed the type of encephalopathy that would automatically qualify for compensation. Scientists subsequently have discovered genetic mutations that cause some of the most severe forms of epilepsy.

What’s different now, though, is that Kennedy, as HHS secretary, has the power to add autism or other disorders to that injury table. Experts say he’d have to go through the federal government’s cumbersome rulemaking process to do so. He could also lean on federal employees to green-light more claims.

In addition, Kennedy has made it clear he’s thinking about illnesses beyond autism. “We have now this epidemic of immune dysregulation in our country, and there’s no way to rule out vaccines as one of the key culprits,” he told Carlson. Kennedy mentioned diabetes, rheumatoid arthritis, seizure disorders, ADHD, speech delay, language delay, tics, Tourette syndrome, narcolepsy, peanut allergies, and eczema.

President Donald Trump’s budget estimated that the value of the investments in the Vaccine Injury Compensation Program trust fund could reach $4.8 billion this year. While that’s a lot of money, a life-care plan for a child with severe autism can cost tens of millions of dollars, and the CDC reported in April that 1 in 31 children is diagnosed with autism by their 8th birthday. The other illnesses Kennedy mentioned also affect a wide swath of the US population.

Dr. Paul Offit, a co-inventor of a rotavirus vaccine and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, for years has sparred with Kennedy over vaccines. Offit fears that Kennedy will use flawed studies to justify adding autism and other common medical problems to the injury table, no matter how much they conflict with robust scientific research.

“You can do that, and you will bankrupt the program,” he said. “These are ways to end vaccine manufacturing in this country.”

If the trust fund were to run out of money, Congress would have to act, said Dorit Reiss, a law professor at University of California Law San Francisco who has studied the Vaccine Injury Compensation Program. Congress could increase the excise tax on vaccines, she said, or pass a law limiting what’s on the injury table. Or Congress could abolish the program, and the vaccine makers would find themselves back in the situation they faced in the 1980s.

“That’s not unrealistic,” Reiss said.

Rep. Paul Gosar, an Arizona Republican, last year proposed the End the Vaccine Carveout Act, which would have allowed people to bypass the no-fault system and head straight to civil court. His press release for the bill—written in September, before Kennedy’s ascension to HHS secretary—quoted Kennedy saying, “If we want safe and effective vaccines, we need to end the liability shield.”

The legislation never came up for a vote. A spokesperson for the congressman said he expects to introduce it again “in the very near future.”

Renée Gentry, director of the George Washington University Law School’s Vaccine Injury Litigation Clinic, thinks it’s unlikely Congress will blow up the no-fault program. But Gentry, who represents people filing claims for injuries, said it’s hard to predict what Congress, faced with a doomsday scenario, would do.

“Normally Democrats are friends of plaintiffs’ lawyers,” she said. “But talking about vaccines on the Hill is like walking on a razor blade that’s on fire.”

RFK Jr. wants to change program that stopped vaccine makers from leaving US market Read More »

Trump’s claims of a Coca-Cola agreement quickly go flat as nutritionists groan

ama, cane sugar, coca-cola, health, High fructose corn syrup, Sugar, Trump / Beth Washington / July 19, 2025

The cloying praise for the still-unconfirmed switch that Coca-Cola has, in fact, not announced was doused with some cold reality from Coca-Cola. While continuing not to confirm the agreement, the soda maker seemed to respond to the “artificial” bit in Fox’s post, saying that HFCS is “just a sweetener made from corn. It’s safe; it has about the same number of calories per serving as table sugar and is metabolized in a similar way by your body.”

The beverage maker also said that the American Medical Association “confirmed that HFCS is no more likely to contribute to obesity than table sugar or other full-calorie sweeteners.”

A 2008 report from the AMA concluded that “Because the composition of HFCS and sucrose are so similar, particularly on absorption by the body, it appears unlikely that HFCS contributes more to obesity or other conditions than sucrose.” Though the medical association noted a lack of research directly comparing the sweeteners.

While political critics suggest that the fizzy Coke fuss is just a distraction from the president’s ongoing Epstein file scandal, health experts are shaking their heads.

Nutrition expert Marion Nestle, professor emeritus at New York University, told Stat News that the push for cane sugar, just like the push to remove artificial dyes from processed foods, was “nutritionally hilarious.” Whether Coke is sweetened with cane sugar or HFCS, it still contains the equivalent of about 10 teaspoons of sugar per 12-ounce can and poses risks for conditions such as Type 2 diabetes and cardiovascular disease. “It’s the kind of thing that makes nutritionists roll their eyes, because it doesn’t make any difference,” Nestle said.

Trump’s claims of a Coca-Cola agreement quickly go flat as nutritionists groan Read More »

Trump admin squanders nearly 800,000 vaccines meant for Africa: Report

health, mpox, trump administration, USAID, vaccines, WHO / Kelly Newman / July 18, 2025

Nearly 800,000 doses of mpox vaccine pledged to African countries working to stamp out devastating outbreaks are headed for the waste bin because they weren’t shipped in time, according to reporting by Politico.

The nearly 800,000 doses were part of a donation promised under the Biden administration, which was meant to deliver more than 1 million doses. Overall, the US, the European Union, and Japan pledged to collectively provide 5 million doses to nearly a dozen African countries. The US has only sent 91,000 doses so far, and only 220,000 currently still have enough shelf life to make it. The rest are expiring within six months, making them ineligible for shipping.

“For a vaccine to be shipped to a country, we need a minimum of six months before expiration to ensure that the vaccine can arrive in good condition and also allow the country to implement the vaccination,” Yap Boum, an Africa CDC deputy incident manager, told Politico.

Politico linked the vaccines’ lack of timely shipment to the Trump administration’s brutal cuts to foreign aid programs as well as the annihilation of the US Agency for International Development (USAID), which administered those aid programs.

Trump admin squanders nearly 800,000 vaccines meant for Africa: Report Read More »

Large study squashes anti-vaccine talking points about aluminum

ACIP, aluminum, anti-vaccine, health, robert f kennedy jr, vaccine / Shannon Garcia / July 16, 2025

A sweeping analysis of health data from more than 1.2 million children in Denmark born over a 24-year period found no link between the small amounts of aluminum in vaccines and a wide range of health conditions—including asthma, allergies, eczema, autism, and attention deficit-hyperactivity disorder (ADHD).

The finding, published in the Annals of Internal Medicine, firmly squashes a persistent anti-vaccine talking point that can give vaccine-hesitant parents pause.

Small amounts of aluminum salts have been added to vaccines for decades as adjuvants, that is, components of the vaccine that help drum up protective immune responses against a target germ. Aluminum adjuvants can be found in a variety of vaccines, including those against diphtheria, tetanus, and pertussis, Haemophilus influenzae type b (Hib), and hepatitis A and B.

Despite decades of use worldwide and no clear link to harms, concern about aluminum and cumulative exposures continually resurfaces—largely thanks to anti-vaccine advocates who fearmonger about the element. A leader of such voices is Robert F. Kennedy Jr, the current US health secretary and an ardent anti-vaccine advocate.

In a June 2024 interview with podcaster Joe Rogan, Kennedy falsely claimed that aluminum is “extremely neurotoxic” and “give[s] you allergies.” The podcast has racked up nearly 2 million views on YouTube. Likewise, Children’s Health Defense, the rabid anti-vaccine organization Kennedy created in 2018, has also made wild claims about the safety of aluminum adjuvants. That includes linking it to autism, despite that many high-quality scientific studies have found no link between any vaccines and autism.

While anti-vaccine advocates like Kennedy routinely dismiss and attack the plethora of studies that do not support their dangerous claims, the new study should reassure any hesitant parents.

Clear data, unclear future

For the study, lead author Niklas Worm Andersson, of the Statens Serum Institut in Copenhagen, and colleagues tapped into Denmark’s national registry to analyze medical records of over 1.2 million children born in the country between 1997 and 2018. During that time, new vaccines were introduced and recommendations shifted, creating variation in how many aluminum-containing vaccines children received.

Large study squashes anti-vaccine talking points about aluminum Read More »

Man’s heart stopped after common bacterium caused ultra-rare infection

endocarditis, health, heart, infection, whipple's disease / 9u50fv / July 12, 2025

A 51-year-old man showed up at a hospital in Germany looking as though he was wasting away, with swelling and tenderness in his ankles and knees. Then, his heart stopped.

Doctors were able to resuscitate him. Then, they got to work trying to figure out what was wrong. The man told them that for three months he had been suffering from diarrhea, weight loss, joint pain, and fever. His case was reported in this week’s issue of the New England Journal of Medicine.

Blood tests didn’t detect any infection, but imaging of his heart told a different story. Doctors saw “vegetation” on both his aortic valve and mitral valve. Vegetations are clumps or masses that often build up from an infection, generally containing a bundle of proteins, platelets, and infecting germs stuck together. While they cause damage where they are, if they fully dislodge, they threaten to move to other parts of the body, such as the brain or lungs, and cause dangerous blockages. In the man’s case, the vegetation on his aortic valve appeared mobile.

The man was quickly sent to emergency surgery to replace his valves. Once removed, the diseased valves were sent for testing to see what was in those dangerous masses. The result likely came as a surprise to the doctors.

The man had in his heart Tropheryma whipplei, a very common environmental bacterium that dwells in soil. Only in exceedingly rare cases does it cause an infection—but when it does it’s a systemic, chronic, and sometimes life-threatening one called Whipple’s disease. The condition affects about one to three people in a million, most often middle-aged Caucasian men, like the patient in this case. Overall, 85 percent of Whipple’s disease cases are in men.

Curious condition

So, how can such a common germ also cause such a rare infection? Researchers think it’s due to genetic predisposition and a glitch in immune responses. Many people likely get infected with T. whipplei as kids, and have either an asymptomatic or limited gastrointestinal infection. They then develop protective immune responses. But in the few people who develop Whipple’s disease, this process seems to go awry. Researchers hypothesize that white blood cells called macrophages—which normally engulf and destroy invading pathogens—aren’t able to finish the job. They engulf T. whipplei, but don’t neutralize the germ. When this happens, the immune system doesn’t generate protective antibodies against the bacterium, and inflammation ratchets up. This, in turn, leads to the development of a systemic infection.

Man’s heart stopped after common bacterium caused ultra-rare infection Read More »

RFK Jr. may be about to demolish preventive health panel, health groups fear

ACIP, health, preventive health, robert f kennedy jr, USPSTF / DJ Henderson / July 11, 2025

“Worrying”

With the latest cancellation, experts fear the USPSTF is next. “This is very worrying, because if past is prologue, it may suggest that they are preparing to eliminate or emasculate the committee,” Peter Lurie, executive director of the Center for Science in the Public Interest, told The New York Times.

Such concerns were first raised after a June 27 US Supreme Court ruling that upheld the provision in the Affordable Care Act that requires health plans to cover USPSTF A- and B-grade recommendations. The ruling preserved critical preventive care coverage but affirmed Kennedy’s authority to control the task force—such as replacing members and undoing recommendations.

In a letter to Congress this week, health and medical organizations urged lawmakers to protect the USPSTF from Kennedy, noting the Supreme Court ruling. In the wake of the ruling, they wrote, “It is critical that Congress protects the integrity of the USPSTF from intentional or unintentional political interference. The loss of trustworthiness in the rigorous and nonpartisan work of the Task Force would devastate patients, hospital systems, and payers as misinformation creates barriers to accessing lifesaving and cost effective care.”

The letter was led by nonprofit health professional organization AcademyHealth and signed by over 100 other organizations, including the American Medical Association, the American Academy of Pediatrics, and the American Public Health Association.

RFK Jr. may be about to demolish preventive health panel, health groups fear Read More »

Woman takes 10x dose of turmeric, gets hospitalized for liver damage

health, liver, supplements, toxicity, turmeric / 9u50fv / July 11, 2025

A 57-year-old woman spent six days in the hospital for severe liver damage after taking daily megadoses of the popular herbal supplement turmeric, which she had seen touted on social media, according to NBC News.

The woman, Katie Mohan, told the outlet that she had seen a doctor on Instagram suggesting it was useful against inflammation and joint pain. So, she began taking turmeric capsules at a dose of 2,250 mg per day. According to the World Health Organization, an acceptable daily dose is up to 3 mg per kilogram of weight per day—for a 150-pound (68 kg) adult, that would be about 204 mg per day. Mohan was taking more than 10 times that amount.

A few weeks later, she developed stomach pain, nausea, fatigue, and dark urine. “I just did not feel well generally,” she said.

After seeing a news report about the possibility of toxicity from turmeric, she connected her symptoms to the pills and went to urgent care. Blood tests revealed her liver enzyme levels were 60 times higher than the normal limit, suggesting liver damage. She was admitted to a local hospital and then transferred to NYU Langone in New York City. Her hepatologist there, Nikolaos Pyrsopoulos, said she was “one step before full liver damage, liver failure, requiring liver transplant.”

Rare toxicity

Generally, turmeric—a golden-colored staple of curries—is not harmful, particularly in foods. But, as herbal supplements have gained popularity and doses have gotten larger, doctors have reported a rise in liver injuries from the spice. In fact, while rare overall, turmeric appears to have become the most common herbal cause of liver injuries in the US.

Woman takes 10x dose of turmeric, gets hospitalized for liver damage Read More »

Weird chemical used in plastics has erupted as latest fentanyl adulterant

BTMPS, fentanyl, health, illicit drugs, toxicity / DJ Henderson / July 10, 2025

Urgent questions

And it wasn’t just found in a few samples at each location—in Los Angeles, for instance, it was present in 56 percent of drug samples in September, and 32 percent in Philadelphia. It also wasn’t just found in trace amounts. In a study of 98 samples of BTMPS-tainted fentanyl, 63 percent of samples contained more BTMPS than fentanyl. Fourteen samples had BTMPS levels that were 10 times higher than the fentanyl content.

While it’s unclear why BTMPS, of all chemicals, has shown up in illicit drugs, researchers have some ideas. For one, BTMPS could simply be a cheap bulking agent that allows makers to dilute fentanyl and maximize profits. The substantial amounts of BTMPS in some samples lend weight to this hypothesis. But another possibility is that makers are using the UV-protection feature that the light stabilizer provides to extend the shelf life of drugs.

It’s also possible it’s simply an accidental contaminant, but researchers suspect that, given the rapid and widespread emergence, its addition is deliberate and likely early in the production process.

How BTMPS affects users is another big question. Animal studies suggest that BTMPS can interact with cell receptors in the heart and nervous system. This raises the possibility of cardiotoxic effects, like low blood pressure and cardiovascular collapse, as well as neurological toxicity, such as muscle weakness or dysfunction of the autonomic nervous system, which controls things like heart rate and breathing.

Anecdotal clinical reports link use of BTMPS to blurred vision, pink eye, ringing in the ears, and nausea. There are also reports of skin irritation and burning after injection, and, after smoking, throat irritation, coughing, and coughing up blood.

Researchers say clinical research on the component is now urgently needed, as well as more surveillance.

Weird chemical used in plastics has erupted as latest fentanyl adulterant Read More »

Mighty mitochondria: Cell powerhouses harnessed for healing

health, mitochondria, Science, syndication / DJ Henderson / July 10, 2025

rescuing suboptimal organs

Researchers hope a new technique can treat a variety of damaged organs.

James McCully was in the lab extracting tiny structures called mitochondria from cells when researchers on his team rushed in. They’d been operating on a pig heart and couldn’t get it pumping normally again.

McCully studies heart damage prevention at Boston Children’s Hospital and Harvard Medical School and was keenly interested in mitochondria. These power-producing organelles are particularly important for organs like the heart that have high energy needs. McCully had been wondering whether transplanting healthy mitochondria into injured hearts might help restore their function.

The pig’s heart was graying rapidly, so McCully decided to try it. He loaded a syringe with the extracted mitochondria and injected them directly into the heart. Before his eyes, it began beating normally, returning to its rosy hue.

Since that day almost 20 years ago, McCully and other researchers have replicated that success in pigs and other animals. Human transplantations followed, in babies who suffered complications from heart surgery—sparking a new field of research using mitochondria transplantation to treat damaged organs and disease. In the last five years, a widening array of scientists have begun exploring mitochondria transplantation for heart damage after cardiac arrest, brain damage following stroke, and damage to organs destined for transplantation.

This graphic depicts the basic steps and results of mitochondrial transplantation. Scientists think that donor mitochondria fuse with the recipient cells’ mitochondrial networks. Then they work to shrink the size of the infarct (the area of tissue dying from lack of blood and oxygen), among other effects. Scientists have studied such transplants in kidneys, livers, muscle, brains, hearts, and lungs. Credit: Knowable Magazine

Mitochondria are best known for producing usable energy for cells. But they also send molecular signals that help to keep the body in equilibrium and manage its immune and stress responses. Some types of cells may naturally donate healthy mitochondria to other cells in need, such as brain cells after a stroke, in a process called mitochondria transfer. So the idea that clinicians could boost this process by transplanting mitochondria to reinvigorate injured tissue made sense to some scientists.

From studies in rabbits and rat heart cells, McCully’s group has reported that the plasma membranes of cells engulf the mitochondria and shuttle them inside, where they fuse with the cell’s internal mitochondria. There, they seem to cause molecular changes that help recover heart function: When comparing blood- and oxygen-deprived pig hearts treated with mitochondria to ones receiving placebos, McCully’s group saw differences in gene activity and proteins that indicated less cell death and less inflammation.

About 10 years ago, Sitaram Emani, a cardiac surgeon at Boston Children’s Hospital, reached out to McCully about his work with animal hearts. Emani had seen how some babies with heart defects couldn’t fully recover after heart surgery complications and wondered whether McCully’s mitochondria transplantation method could help them.

During surgery to repair heart defects, surgeons use a drug to stop the heart so they can operate. But if the heart is deprived of blood and oxygen for too long, mitochondria start to fail and cells start to die, in a condition called ischemia. When blood begins flowing again, instead of returning the heart to its normal state, it can damage and kill more cells, resulting in ischemia-reperfusion injury.

Since McCully’s eight years of studies in rabbits and pigs hadn’t revealed safety concerns with mitochondria transplantation, McCully and Emani thought it would be worth trying the procedure in babies unlikely to regain enough heart function to come off heart-lung support.

Parents of 10 patients agreed to the experimental procedure, which was approved by the institute’s review board. In a pilot that ran from 2015 to 2018, McCully extracted pencil-eraser-sized muscle samples from the incisions made for the heart surgery, used a filtration technique to isolate mitochondria and checked that they were functional. Then the team injected the organelles into the baby’s heart.

Eight of those 10 babies regained enough heart function to come off life support, compared to just four out of 14 similar cases from 2002 to 2018 that were used for historical comparison, the team reported in 2021. The treatment also shortened recovery time, which averaged two days in the mitochondrial transplant group compared with nine days in the historical control group. Two patients did not survive — in one case, the intervention came after the rest of the baby’s organs began failing, and in another, a lung issue developed four months later. The group has now performed this procedure on 17 babies.

The transplant procedure remains experimental and is not yet practical for wider clinical use, but McCully hopes that it can one day be used to treat kidney, lung, liver, and limb injuries from interrupted blood flow.

The results have inspired other clinicians whose patients suffer from similar ischemia-reperfusion injuries. One is ischemic stroke, in which clots prevent blood from reaching the brain. Doctors can dissolve or physically remove the clots, but they lack a way to protect the brain from reperfusion damage. “You see patients that lose their ability to walk or talk,” says Melanie Walker, an endovascular neurosurgeon at the University of Washington School of Medicine in Seattle. “You just want to do better and there’s just nothing out there.”

Walker came across McCully’s mitochondrial transplant studies 12 years ago and, in reading further, was especially struck by a report on mice from researchers at Massachusetts General Hospital and Harvard Medical School that showed the brain’s support and protection cells—the astrocytes—may transfer some of their mitochondria to stroke-damaged neurons to help them recover. Perhaps, she thought, mitochondria transplantation could help in human stroke cases too.

She spent years working with animal researchers to figure out how to safely deliver mitochondria to the brain. She tested the procedure’s safety in a clinical trial with just four people with ischemic stroke, using a catheter fed through an artery in the neck to manually remove the blockage causing the stroke, then pushing the catheter further along and releasing the mitochondria, which would travel up blood vessels to the brain.

The findings, published in 2024 in the Journal of Cerebral Blood Flow & Metabolism, show that the infused patients suffered no harm; the trial was not designed to test effectiveness. Walker’s group is now recruiting participants to further assess the intervention’s safety. The next step will be to determine whether the mitochondria are getting where they need to be, and functioning. “Until we can show that, I do not believe that we will be able to say that there’s a therapeutic benefit,” Walker says.

Researchers hope that organ donation might also gain from mitochondria transplants. Donor organs like kidneys suffer damage when they lack blood supply for too long, and transplant surgeons may reject kidneys with a higher risk of these injuries.

To test whether mitochondrial transplants can reinvigorate them, transplant surgeon-scientist Giuseppe Orlando of Wake Forest University School of Medicine in Winston-Salem and his colleagues injected mitochondria into four pig kidneys and a control substance into three pig kidneys. In 2023 in the Annals of Surgery, they reported fewer dying cells in the mitochondria-treated kidneys and far less damage. Molecular analyses also showed a boost in energy production.

It’s still early days, Orlando says, but he’s confident that mitochondria transplantation could become a valuable tool in rescuing suboptimal organs for donation.

The studies have garnered both excitement and skepticism. “It’s certainly a very interesting area,” says Koning Shen, a postdoctoral mitochondrial biologist at the University of California, Berkeley, and coauthor of an overview of the signaling roles of mitochondria in the 2022 Annual Review of Cell and Developmental Biology. She adds that scaling up extraction of mitochondria and learning how to store and preserve the isolated organelles are major technical hurdles to making such treatments a larger reality. “That would be amazing if people are getting to that stage,” she says.

“I think there are a lot of thoughtful people looking at this carefully, but I think the big question is, what’s the mechanism?” says Navdeep Chandel, a mitochondria researcher at Northwestern University in Chicago. He doubts that donor mitochondria fix or replace dysfunctional native organelles, but says it’s possible that mitochondria donation triggers stress and immune signals that indirectly benefit damaged tissue.

Whatever the mechanism, some animal studies do suggest that the mitochondria must be functional to impart their benefits. Lance Becker, chair of emergency medicine at Northwell Health in New York who studies the role of mitochondria in cardiac arrest, conducted a study comparing fresh mitochondria, mitochondria that had been frozen then thawed, and a placebo to treat rats following cardiac arrest. The 11 rats receiving fresh, functioning mitochondria had better brain function and a higher rate of survival three days later than the 11 rats receiving a placebo; the non-functional frozen-thawed mitochondria did not impart these benefits.

It will take more research into the mechanisms of mitochondrial therapy, improved mitochondria delivery techniques, larger trials and a body of reported successes before mitochondrial transplants can be FDA-approved and broadly used to treat ischemia-reperfusion injuries, researchers say. The ultimate goal would be to create a universal supply of stored mitochondria — a mitochondria bank, of sorts — that can be tapped for transplantation by a wide variety of health care providers.

“We’re so much at the beginning—we don’t know how it works,” says Becker. “But we know it’s doing something that is mighty darn interesting.”

This article originally appeared in Knowable Magazine, a nonprofit publication dedicated to making scientific knowledge accessible to all. Sign up for Knowable Magazine’s newsletter.

Knowable Magazine explores the real-world significance of scholarly work through a journalistic lens.

Mighty mitochondria: Cell powerhouses harnessed for healing Read More »