health

why-a-diabetes-drug-fell-short-of-anticancer-hopes

Why a diabetes drug fell short of anticancer hopes


Studies suggested it could treat cancer, but the clinical trials were a bust.

Multi-pipettes

Pamela Goodwin has received hundreds of emails from patients asking if they should take a cheap, readily available drug, metformin, to treat their cancer.

It’s a fair question: Metformin, commonly used to treat diabetes, has been investigated for treating a range of cancer types in thousands of studies on laboratory cells, animals, and people. But Goodwin, an epidemiologist and medical oncologist treating breast cancer at the University of Toronto’s Mount Sinai Hospital, advises against it. No gold-standard trials have proved that metformin helps treat breast cancer—and her recent research suggests it doesn’t.

Metformin’s development was inspired by centuries of use of French lilac, or goat’s rue (Galega officinalis), for diabetes-like symptoms. In 1918, researchers discovered that a compound from the herb lowers blood sugar. Metformin, a chemical relative of that compound, has been a top type 2 diabetes treatment in the United States since it was approved in 1994. It’s cheap—less than a dollar per dose—and readily available, with few side effects. Today, more than 150 million people worldwide take the stuff.

Illustration of French lilac plant.

The French lilac, Galega officinalis, has been used medicinally since medieval times, including for symptoms associated with diabetes. Investigations of the plant’s chemical galegine led to the development of metformin, a related molecule synthesized in the lab. Credit: Wikimedia Commons

Metformin has a variety of effects, such as improving immune function and the body’s responses to insulin, which in turn regulates blood sugar. It can also slow growth of cancer cells in the lab. Many of these benefits seem to stem from metformin’s action in the cell’s powerhouses, the mitochondria, where it slows the production of energy and limits the generation of damaging chemicals called free radicals.

Researchers have considered metformin for treating a plethora of conditions, from glaucoma to polycystic ovary syndrome to pimples. “It really has a reputation of being a potential wonder drug,” says Michael Pollak, an oncologist and researcher at McGill University in Montreal. “There’s still a lot of work to be done on metformin.” (Pollak consults for biotechnology companies interested in metformin analogs as medicines.)

But the latest research has convinced Pollak and some others that treatment of cancers should be taken off the list.

More studies, but no proof

One of the first hints linking metformin to anticancer effects came in a short note in the British Medical Journal in 2005. Researchers analyzed medical records of almost 12,000 people from the Tayside region of Scotland who were newly diagnosed with diabetes between 1993 and 2001. Of those, more than 900 went on to develop cancer. Interestingly, those who’d taken metformin at some point during the study period were 23 percent less likely to have received a later cancer diagnosis.

This finding fueled further research on people with diabetes taking metformin and the risk for breast cancer, liver cancer, ovarian and endometrial cancer, and other types. The authors of a 2013 analysis, covering more than 1 million patients in 41 observational studies like the original one, concluded that metformin “might be associated with a significant reduction in the risk of cancer.” But such associations are not proof.

Researchers went on to explore the link in studies with cells in dishes and in lab animals, finding that metformin slowed growth of blood, breast, endometrial, lung, liver, stomach, and thyroid cancer cells. It also seemed to make cancer cells extra sensitive to chemotherapy drugs. In one mouse study, scientists grafted human breast, prostate, or lung cancer cells into the animals and treated them with either standard chemotherapy drugs, metformin, or a combination of both. The combination worked best, preventing tumor growth and prolonging relapse.

These findings made sense to researchers. Metformin treats metabolic problems in diabetes, and cancer has also been linked to metabolic issues such as obesity. Even before the 2005 British Medical Journal study, Goodwin had noticed that breast cancer patients with high insulin did worse than those with normal insulin levels.

That logic, plus the promising data, led scientists to conduct a number of randomized controlled trials—the gold-standard experiment in medicine. Researchers would enroll people with cancer and split them into two groups. One group would get standard cancer therapy plus metformin; the other group would get standard therapy plus a placebo, a pill containing no medication.

And metformin flopped, big time. While a number of studies are ongoing, trials for two types of cancer recently reported no benefit overall from metformin. In June 2024, at the American Society of Clinical Oncology meeting in Chicago, researchers reported a Canadian trial with 407 men with low-risk prostate cancer. The enrollees had been diagnosed within six months before starting the trial and had decided to monitor their cancer without starting immediate treatment. Half took metformin and half took a placebo. After biopsies at 18 and 36 months to test whether their disease had progressed, there was no difference between the two groups.

A larger British and Swiss trial including nearly 1,900 patients with newly diagnosed or relapsed prostate cancer that had spread to other body parts was reported at the European Society for Medical Oncology Congress in Barcelona, Spain, in September. This trial also found that metformin plus standard treatment, compared to standard treatment alone, did not improve overall prostate cancer survival in the study population.

A multinational study of breast cancer helmed by Goodwin also led to disappointment. The researchers enrolled more than 3,600 patients between 2010 and 2013; these patients had been diagnosed about a year before enrollment and had already undergone chemotherapy and surgery. In addition to standard cancer treatment, half received metformin and half received a placebo.

By 2016, it was clear that metformin wasn’t doing anything to enhance survival for about 1,100 participants with a particular cancer subtype. When the study wrapped in 2020, the researchers analyzed the rest of the patients, counting how many were alive and free of breast or any other form of cancer. Metformin made no difference in those results, or to survival overall, the team reported in 2022.

Fatal flaws in the research

In retrospect, researchers think they know why earlier studies oversold metformin’s potential. Many of the studies that examined medical records had a crucial flaw, says Samy Suissa, a pharmacoepidemiologist at McGill.

Here’s what happens: Researchers sift through old medical records to see if someone ever took metformin. Then they compare cancer rates among people who took the drug at any point to those who never took it. But you have to be alive to take metformin. Anyone who died, of cancer or other causes, before having a chance at a metformin prescription is left out of the calculations. This skews the results; it’s called the “immortal time bias.” It makes any drug, metformin or otherwise, look like it helps patients to survive because it can only be taken by people who are alive, says Suissa.

Plus, scientists are more likely to publish studies that show metformin is promising than ones where it makes no difference, skewing the scientific literature.

As for those studies of cells in dishes and of lab animals, many experiments used much higher doses of metformin than are used in people. Too much metformin risks a buildup of lactate, a byproduct of low oxygen metabolism that acidifies the blood and can be fatal.

Researchers still suspect metformin might treat specific subgroups of cancer. For example, the authors of the prostate cancer trial presented in Barcelona suggested that metformin might help patients whose cancer has spread to other tissues or multiple sites in their bones. And Goodwin saw a hint in her trial that it might help women whose cancers contain a certain version of a cell-growth gene called ERBB2. But it would require another trial, focused on women with that particular cancer, to prove it.

And there are now better treatments for those patients than there were more than a decade ago when Goodwin started her study, reducing the opportunity to test metformin. Goodwin doesn’t currently have the funding to follow up on this theory.

It may also be that the clinical trials recruited patients with cancers that were too far along. “I always thought we were asking too much of metformin,” says Victoria Bae-Jump, a gynecological oncologist at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill. “Maybe it just needs to be earlier in the pathway of growth.” Bae-Jump is now testing metformin in women who have early-stage endometrial cancer or a precursor to it.

Others are investigating metformin for people who have precancerous lesions in their mouths. “The idea would be to keep them from progressing, or reverse the tissues to be more normal,” says Frank Ondrey, a head and neck cancer surgeon at the Masonic Cancer Center of the University of Minnesota in Minneapolis. In a small, uncontrolled study of 23 people, metformin halved lesion size in four of them. Ondrey is involved in two ongoing studies, one a randomized, controlled trial, to further test metformin in people with precancerous lesions; these should yield results within a few years.

Subdued expectations

Metformin is also being tested for other conditions such as dementia and a genetic disorder called fragile X syndrome. And perhaps the ultimate potential use for metformin is to slow aging itself. “I think it’s much easier to treat aging and prevent cancer than to treat cancer,” says Nir Barzilai, a geroscientist at Albert Einstein College of Medicine in New York and president of the nonprofit Academy for Health & Lifespan Research. Through its enhancement of insulin action and metabolism plus its minimization of free radical production, metformin influences all the key hallmarks of aging, such as problems with DNA, mitochondria and stem cells, says Barzilai.

He and colleagues are gathering funds for a randomized, controlled trial of metformin in 3,000 people age 65 through 79 who are showing signs of age-related disease already. The trial will test whether fewer people taking metformin die over six years. Barzilai, who is 68, says he is confident in metformin’s anti-aging ability and already takes the drug himself.

Others, mindful of what happened with cancer, are more circumspect. Pollak says that many of the studies in other areas of medicine are too small to prove metformin works, and Suissa notes that some of the studies finding benefits in populations taking metformin, including for longevity, have the same problems the oh-so-promising early cancer research did.

In short, Suissa says, “Don’t believe everything you hear.”

This story originally appeared in Knowable Magazine.

Photo of Knowable Magazine

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

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Rare bear meat at gathering gives 10 people a scare—and parasitic worms

If you’re going to eat a bear, make sure it’s not rare.

You’d be forgiven for thinking that once the beast has been subdued, all danger has passed. But you might still be in for a scare. The animal’s flesh can be riddled with encased worm larvae, which, upon being eaten, will gladly reproduce in your innards and let their offspring roam the rest of your person, including invading your brain and heart. To defeat these savage squirmers, all one must do is cook the meat to at least 165° Fahrenheit.

But that simple solution continues to be ignored, according to a report today in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report. In this week’s issue, health officials in North Carolina report that rare bear meat was served at a November 23 gathering, where at least 22 people ate the meat and at least 10 developed symptoms of a worm infection. Of the 10, six were kids and teens between the ages of 10 and 18.

The infection is from the roundworm Trichinella, which causes trichinellosis. While the infection is rarely fatal, the nematodes tend to burrow out of the bowels and meander through the body, embedding in whatever muscle tissue they come across. A telltale sign of an infection in people is facial swelling, caused when the larvae take harbor in the muscles of the face and around the eyes. Of the 10 ill people in North Carolina, nine had facial swelling.

Local health officials were onto the outbreak when one person developed flu-like symptoms and puzzling facial swelling. They then traced it back to the gathering. The report doesn’t specify what kind of gathering it was but noted that 34 attendees in total were surveyed, from which they found the 22 people who ate the rare meat. The 10 people found with symptoms are technically considered only “probable” cases because the infections were never diagnostically confirmed. To confirm a trichinellosis infection, researchers need blood samples taken after the person recovers to look for antibodies against the parasite. None of the 10 people returned for blood draws.

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Over 86% of surveyed health care providers are short on IV fluids

Trucks and Gatorade

Federal officials, meanwhile, are working with Baxter to help support increasing supplies, setting up temporary imports, and expediting consideration of any shelf-life extension requests.

In a letter earlier this week, Department of Health and Human Services Secretary Xavier Becerra told health care leaders that the department is “working tirelessly to mitigate the sterile solutions supply chain disruptions” and, beyond the current crisis, is also working to diversify the supply chain so it is less reliant on a single plant.

For now, though, “HHS is encouraging all providers and health systems, regardless of whether they have experienced a disruption in their supply, to take measures to conserve these critical products,” the letter read. Some hospitals have already reported giving patients Gatorade and Pedialyte to conserve IV fluid supplies.

In one bright spot in the current disruptions, fears that Hurricane Milton would disrupt another IV fluid manufacturing plant in Florida were not realized this week. B. Braun Medical’s manufacturing site in Daytona Beach was not seriously impacted by the storm, the company announced, and production resumed normally Friday. Prior to the storm, with the help of the federal government, B. Braun reportedly moved more than 60 truckloads of IV fluid inventory north of Florida for safekeeping. That inventory will be returned to the Daytona facility, according to reporting by the Associated Press.

Over 86% of surveyed health care providers are short on IV fluids Read More »

drug-makers-can’t-make-knockoff-weight-loss-drugs-anymore—and-they’re-mad

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad

Compounding pharmacies are suing the Food and Drug Administration so they can keep making imitation versions of popular—and lucrative—tirzepatide drugs, namely knockoffs of Mounjaro for diabetes and Zepbound for weight loss.

Generally, compounding pharmacies make customized formulations of drugs for patients with specific needs, like when a patient has an allergy to a filler ingredient or if a child needs a liquid version of a drug that normally comes as a capsule. But larger compounding operations are also legally allowed to make imitations of branded drugs if those drugs are in short supply, acting as a stopgap for patients.

Tirzepatide has certainly been in short supply in recent years. Given the high prevalence of diabetes and obesity in America and the drug’s effectiveness, demand for tirzepatide and other drugs in the new GLP-1 class have skyrocketed, and many patients have struggled to fill prescriptions. The FDA placed tirzepatide on its drug shortage list in December of 2022—and that’s where it remained until last week.

On October 2, the FDA announced that the tirzepatide shortage had been resolved and that the nation’s supply of GLP-1 drugs was stabilizing, though other drugs in the class, including semaglutide, remain in short supply.

“FDA confirmed with the drug’s manufacturer [Eli Lilly] that their stated product availability and manufacturing capacity can meet the present and projected national demand,” the agency said in its announcement. However, it cautioned that patients and prescribers “may still see intermittent localized supply disruptions” as the drugs move through the supply chain.

End of an era

With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”

Drug makers can’t make knockoff weight-loss drugs anymore—and they’re mad Read More »

your-doctor’s-office-could-be-reading-your-blood-pressure-all-wrong

Your doctor’s office could be reading your blood pressure all wrong

Under pressure

Before participants took readings in any of the positions, the researchers had them simulate walking into a doctor’s appointment. They walked for two minutes and then sat calmly in position for five minutes before taking the three readings. Before moving onto the next position, they got up and walked again and sat for another five minutes. The participants were also randomized into groups that took the first three readings (desk 1, lap, side) in different orders, with all groups ending on desk 2.

The researchers then compared the differences between desk 1 and desk 2 to differences between lap and desk 1 and side and desk 1 for each participant. The desk 1-desk 2 differences captured intrinsic variability of blood pressure reading within each participant. The comparisons to lap-desk 1 and side-desk 1 captured changes based on the improper arm positions.

In all, there was little difference in the desk 1-desk 2 comparison, with participants having a mean difference of -0.21 mm Hg in systolic blood pressure and 0.09 in diastolic. But, the improper arm positions had significant effects on the readings. Lap arm position resulted in a mean increase of 4 mm Hg in both systolic and diastolic readings. Side arm position led to systolic readings that were 6.5 mm Hg higher and diastolic readings that were 4 mm Hg higher. For those with high blood pressure readings—about 36 percent of the participants—the wrong arm position caused yet higher readings, with systolic readings about 9 mm Hg higher than desk readings.

The authors speculate that simple physiological mechanisms likely explain the increase in blood pressure when the arm is lower than the heart—more gravitational pull, compensatory constriction of blood vessels, and muscle contraction may lead to higher pressure. As for why health care providers are known to sometimes use these wrong arm positions, it may be a lack of awareness, training, equipment, and/or resources.

The authors of the study call for more training and education about proper blood pressure measurements, which are essential for appropriate management of hypertension and prevention of cardiovascular disease.

Your doctor’s office could be reading your blood pressure all wrong Read More »

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SCOTUS denial ends saga of Shkreli’s infamous 5,000% drug price scheme

The legal saga over Martin Shkreli’s infamous 5,000 percent price hike of a life-saving anti-parasitic drug has ended with a flat denial from the highest court in the land.

On Monday, the Supreme Court rejected Shkreli’s petition to appeal an order to return $64.6 million in profits from the pricing scheme of Daraprim, a decades-old drug used to treat toxoplasmosis. The condition is caused by a single-celled parasite that can be deadly for newborns and people with compromised immune systems, such as people who have HIV, cancer, or an organ transplant.

Federal prosecutors successfully argued in courts that Shkreli orchestrated an illegal anticompetitive scheme that allowed him to dramatically raise the price of Daraprim overnight. When Shkreli and his pharmaceutical company, Vyera (formerly Turing), bought the rights to the drug in 2015, the price of a single pill jumped to $750 after being priced between $13.50 and $17.50 earlier that year. And Shkreli quickly came to epitomize callous greed in the pharmaceutical industry.

In a lawsuit filed in 2021, the Federal Trade Commission and seven state attorneys general accused Shkreli of building a “web of anticompetitive restrictions to box out the competition.” In January of 2022, US District Court Judge Denise Cote agreed, finding that Shkreli’s conduct was “egregious, deliberate, repetitive, long-running, and ultimately dangerous.”

SCOTUS denial ends saga of Shkreli’s infamous 5,000% drug price scheme Read More »

helene-ravaged-the-nc-plant-that-makes-60%-of-the-country’s-iv-fluid-supply

Helene ravaged the NC plant that makes 60% of the country’s IV fluid supply

Hurricane Helene’s catastrophic damage and flooding to the Southeastern states may affect the country’s medical supply chain.

Hospitals nationwide are bracing for a possible shortage of essential intravenous fluids after the cataclysmic storm inundated a vital manufacturing plant in North Carolina.

The plant is Baxter International’s North Cove manufacturing facility in Marion, which is about 35 miles northeast of Asheville. Helene unleashed unprecedented amounts of rain throughout the western part of the state, killing dozens and ravaging numerous communities, homes, and other structures, including the plant.

The North Cove plant produces 60 percent of the country’s supply of IV solutions, typically producing 1.5 million bags per day, according to the American Hospital Association. The dozens of sterile solutions Baxter makes at the facility are used for everything from intravenous rehydration and drug delivery to peritoneal dialysis used to treat kidney failure.

“Our hearts and thoughts are with all those affected by Hurricane Helene,” Baxter CEO José Almeida said in a statement on September 29. “The safety of our employees, their families, and the communities in which we operate remains our utmost concern, and we are committed to helping ensure reliable supply of products to patients. Remediation efforts are already underway, and we will spare no resource—human or financial—to resume production and help ensure patients and providers have the products they need.”

Critical supply

On October 2, Mass General Brigham, Massachusetts’ largest hospital and health care system, warned employees via email of a “serious and immediate IV fluid shortage,” according to the Boston Globe.

Helene ravaged the NC plant that makes 60% of the country’s IV fluid supply Read More »

human-case-of-h5n1-suspected-in-california-amid-rapid-dairy-spread

Human case of H5N1 suspected in California amid rapid dairy spread

California’s infections bring the country’s total number of affected herds to 255 in 14 states, according to the USDA.

In a new release Thursday, California health officials worked to ease alarm about the human case, emphasizing that the risk to the general public remains low.

“Ongoing health checks of individuals who interact with potentially infected animals helped us quickly detect and respond to this possible human case. Fortunately, as we’ve seen in other states with human infections, the individual has experienced mild symptoms,” Tomás Aragón, director of California’s Department of Public Health, said. “We want to emphasize that the risk to the general public is low, and people who interact with potentially infected animals should take prevention measures.”

The release noted that in the past four months, the health department has distributed more than 340,000 respirators, 1.3 million gloves, 160,000 goggles and face shields, and 168,000 bouffant caps to farm workers. The state has also received 5,000 doses of seasonal flu vaccine earmarked for farm workers and is working to distribute those vaccines to local health departments.

Still, herd infections and human cases continue to tick up. Influenza researchers and other health experts are anxiously following the unusual dairy outbreak—the first time an avian influenza is known to have spilled over to and caused an outbreak in cattle. The more opportunities the virus has to spread and adapt to mammals, the more chances it could begin spreading among humans, potentially sparking an outbreak or even a pandemic.

Human case of H5N1 suspected in California amid rapid dairy spread Read More »

popular-gut-probiotic-completely-craps-out-in-randomized-controlled-trial

Popular gut probiotic completely craps out in randomized controlled trial

Any striking marketing claims in companies’ ads about the gut benefits of a popular probiotic may be full of, well, the same thing that has their target audience backed up.

In a randomized controlled trial, the probiotic Bifidobacterium animalis subsp. lactis—used in many probiotic products, including Dannon’s Activia yogurts—did nothing to improve bowel health in people with constipation, according to data from a randomized triple-blind placebo-controlled clinical trial published Wednesday in JAMA Network Open.

The study adds to a mixed and mostly unconvincing body of scientific literature on the bowel benefits of the bacterium, substrains of which are sometimes sold with faux scientific-sounding names in products. Dannon, for instance, previously marketed its substrain, DN-173 010, as “Bifidus regularis.”

Digested data

For the new study, researchers in China recruited 228 middle-aged adults, 85 percent of whom were women. The participants, all from Shanghai, were considered healthy based on medical testing and records, except for reporting functional constipation. This is a condition defined by having two or more signs of difficulty evacuating the bowels, such as frequent straining and having rock-like stool. For the study, the researchers included the additional criterion that participants have three or fewer complete, spontaneous bowel movements (CSBMs) per week.

The participants were randomized to take either a placebo (117 participants) or the probiotic (112 participants) every day for eight weeks. Both groups got packets of sweetened powder that participants added to a glass of water taken before breakfast each morning. In addition to a sweetener, the daily probiotic packets contained freeze-dried Bifidobacterium animalis subsp. lactis substrain HN019, which is used in some commercial probiotic products. The first dose had a concentration of 7 × 109 colony-forming units (CFUs), then participants shifted to a daily dose of 4.69 × 109 CFUs. Many probiotic products have doses of B. lactis in ranges from 1 × 109 to 17 × 109.

Popular gut probiotic completely craps out in randomized controlled trial Read More »

lab-owner-pleads-guilty-to-faking-covid-test-results-during-pandemic

Lab owner pleads guilty to faking COVID test results during pandemic

Justice —

Ill-gotten millions bought a Bentley, Lamborghini, Tesla X, and crypto, among other things.

Residents line up for COVID-19 testing on November 30, 2020 in Chicago.

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.

In February 2022, the FBI raided LabElite’s Chicago testing site amid a crackdown on several large-scale fraudulent COVID testing schemes. In March 2023, Alvi was indicted by a federal grand jury on 10 counts of wire fraud and one count of theft of government funds. The indictment sought forfeiture of his ill-gotten riches, which were listed in the indictment.

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.

Lab owner pleads guilty to faking COVID test results during pandemic Read More »

toxic-chemicals-from-ohio-train-derailment-lingered-in-buildings-for-months

Toxic chemicals from Ohio train derailment lingered in buildings for months

This video screenshot released by the US National Transportation Safety Board (NTSB) shows the site of a derailed freight train in East Palestine, Ohio.

Enlarge / This video screenshot released by the US National Transportation Safety Board (NTSB) shows the site of a derailed freight train in East Palestine, Ohio.

On February 3, 2023, a train carrying chemicals jumped the tracks in East Palestine, Ohio, rupturing railcars filled with hazardous materials and fueling chemical fires at the foothills of the Appalachian Mountains.

The disaster drew global attention as the governors of Ohio and Pennsylvania urged evacuations for a mile around the site. Flames and smoke billowed from burning chemicals, and an acrid odor radiated from the derailment area as chemicals entered the air and spilled into a nearby creek.

Three days later, at the urging of the rail company Norfolk Southern, about 1 million pounds of vinyl chloride, a chemical that can be toxic to humans at high doses, was released from the damaged train cars and set aflame.

Federal investigators later concluded that the open burn and the black mushroom cloud it produced were unnecessary, but it was too late. Railcar chemicals spread into Ohio and Pennsylvania.

As environmental engineers, I and my colleagues are often asked to assist with public health decisions after disasters by government agencies and communities. After the evacuation order was lifted, community members asked for help.

In a new study, we describe the contamination we found, along with problems with the response and cleanup that, in some cases, increased the chances that people would be exposed to hazardous chemicals. It offers important lessons to better protect communities in the future.

How chemicals get into homes and water

When large amounts of chemicals are released into the environment, the air can become toxic. Chemicals can also wash into waterways and seep into the ground, contaminating groundwater and wells. Some chemicals can travel below ground into nearby buildings and make the indoor air unsafe.

A computer model shows how chemicals from the train may have spread, given wind patterns. The star on the Ohio-Pennsylvania line is the site of the derailment.

Enlarge / A computer model shows how chemicals from the train may have spread, given wind patterns. The star on the Ohio-Pennsylvania line is the site of the derailment.

Air pollution can find its way into buildings through cracks, windows, doors, and other portals. Once inside, the chemicals can penetrate home items like carpets, drapes, furniture, counters, and clothing. When the air is stirred up, those chemicals can be released again.

Evacuation order lifted, but buildings were contaminated

Three weeks after the derailment, we began investigating the safety of the area near 17 buildings in Ohio and Pennsylvania. The highest concentration of air pollution occurred in the 1-mile evacuation zone and a shelter-in-place band another mile beyond that. But the chemical plume also traveled outside these areas.

In and outside East Palestine, evidence indicated that chemicals from the railcars had entered buildings. Many residents complained about headaches, rashes, and other health symptoms after reentering the buildings.

At one building 0.2 miles away from the derailment site, the indoor air was still contaminated more than four months later.

Nine days after the derailment, sophisticated air testing by a business owner showed the building’s indoor air was contaminated with butyl acrylate and other chemicals carried by the railcars. Butyl acrylate was found above the two-week exposure level, a level at which measures should be taken to protect human health.

When rail company contractors visited the building 11 days after the wreck, their team left after just 10 minutes. They reported an “overwhelming/unpleasent odor” even though their government-approved handheld air pollution detectors detected no chemicals. This building was located directly above Sulphur Run creek, which had been heavily contaminated by the spill. Chemicals likely entered from the initial smoke plumes and also rose from the creek into the building.

Our tests weeks later revealed that railcar chemicals had even penetrated the business’s silicone wristband products on its shelves. We also detected several other chemicals that may have been associated with the spill.

Homes and businesses were mere feet from the contaminated waterways in East Palestine.

Enlarge / Homes and businesses were mere feet from the contaminated waterways in East Palestine.

Weeks after the derailment, government officials discovered that air in the East Palestine Municipal Building, about 0.7 miles away from the derailment site, was also contaminated. Airborne chemicals had entered that building through an open drain pipe from Sulphur Run.

More than a month after the evacuation order was lifted, the Ohio Environmental Protection Agency acknowledged that multiple buildings in East Palestine were being contaminated as contractors cleaned contaminated culverts under and alongside buildings. Chemicals were entering the buildings.

Toxic chemicals from Ohio train derailment lingered in buildings for months Read More »

ceo-of-“health-care-terrorists”-sues-senators-after-contempt-of-congress-charges

CEO of “health care terrorists” sues senators after contempt of Congress charges

“not the way this works” —

Suing an entire Senate panel seen as a “Hail Mary play” unlikely to succeed.

The empty chair of Steward Health Care System Chief Executive Officer, Dr. Ralph de la Torre who did not show up during the US Senate Committee on Health, Education, Labor, & Pensions Examining the Bankruptcy of Steward Health Care: How Management Decisions Have Impacted Patient Care.

Enlarge / The empty chair of Steward Health Care System Chief Executive Officer, Dr. Ralph de la Torre who did not show up during the US Senate Committee on Health, Education, Labor, & Pensions Examining the Bankruptcy of Steward Health Care: How Management Decisions Have Impacted Patient Care.

The infamous CEO of a failed hospital system is suing an entire Senate committee after being held in contempt of Congress, with civil and criminal charges unanimously approved by the full Senate last week.

In a federal lawsuit filed Monday, Steward CEO Ralph de la Torre claimed the senators “bulldozed over [his] constitutional rights” as they tried to “pillory and crucify him as a loathsome criminal” in a “televised circus.”

The Senate committee—the Committee on Health, Education, Labor, and Pensions (HELP), led by Bernie Sanders (I-Vt.)—issued a rare subpoena to de la Torre in July, compelling him to testify before the lawmakers. They sought to question the CEO on the deterioration of his hospital system, which previously included more than 30 hospitals across eight states. Steward filed for bankruptcy in May.

Imperiled patients

The committee alleges that de la Torre and Steward executives reaped millions in personal profits by hollowing out the health care facilities, even selling the land out from under them. The mismanagement left them so financially burdened that one doctor in a Steward-owned hospital in Louisiana said they were forced to perform “third-world medicine.” A lawmaker in that state who investigated the conditions at the hospital described Steward executives as “health care terrorists.”

Further, the financial strain on the hospitals is alleged to have led to the preventable deaths of 15 patients and put more than 2,000 other patients in “immediate peril.” As hospitals cut services, closed wards, or shuttered entirely, hundreds of health care workers were laid off, and communities were left without access to care. Nurses who remained in faltering facilities testified of harrowing conditions, including running out of basic supplies like beds. In one Massachusetts hospital, nurses were forced to place the remains of newborns in cardboard shipping boxes because Steward failed to pay a vendor for bereavement boxes.

Meanwhile, records indicate de la Torre and his companies were paid at least $250 million in recent years and he bought a 190-foot yacht for $40 million. Steward also owned two private jets collectively worth $95 million.

While de la Torre initially agreed to testify before the committee at the September 12 hearing, the wealthy CEO backed out the week beforehand. He claimed that a federal court order linked to the bankruptcy case prevented him from speaking on the matter; additionally, he invoked his Fifth Amendment right to avoid self-incrimination.

The HELP committee rejected de la Torre’s arguments, saying there were still relevant topics he could safely discuss without violating the order and that his Fifth Amendment rights did not permit him to refuse to appear before Congress when summoned by a subpoena. Still, the CEO was a no-show, and the Senate moved forward with the contempt charges.

“Not the way this works”

In the lawsuit filed today, de la Torre argues that the senators are attempting to punish him for invoking his Constitutional rights and that the hearing “was simply a device for the Committee to attack [him] and try to publicly humiliate and condemn him.”

The suit describes de la Torre as having a “distinguished career, bedecked by numerous accomplishments,” while accusing the senators of painting him as “a villain and scapegoat[ing] him for the company’s problems, even those caused by systemic deficiencies in Massachusetts’ health care system.” If he had appeared at the Congressional hearing, he would not have been able to defend himself from the personal attacks without being forced to abandon his Constitutional rights, the suit argues.

“Indeed, the Committee made it abundantly clear that they would put Dr. de la Torre’s invocation [of the Fifth Amendment] itself at the heart of their televised circus and paint him as guilty for the sin of remaining silent in the face of these assaults on his character and integrity,” the suit reads.

De la Torre seeks to have the federal court quash the Senate committee’s subpoena, enjoin both contempt charges, and declare that the Senate committee violated his Fifth Amendment rights.

Outside lawyers are skeptical that will occur. The lawsuit is a “Hail Mary play,” according to Stan M. Brand, an attorney who represented former Trump White House official Peter Navarro in a contempt of Congress case. De la Torre’s case “has very little chance of succeeding—I would say no chance of succeeding,” Brand told the Boston Globe.

“Every time that someone has tried to sue the House or Senate directly to challenge a congressional subpoena, the courts have said, ‘That that’s not the way this works,’” Brand said.

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