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.
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.”
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.
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.”
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.
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.
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.
Enlarge/ Residents line up for COVID-19 testing on November 30, 2020 in Chicago.
The co-owner of a Chicago-based lab has pleaded guilty for his role in a COVID testing scam that raked in millions—which he used to buy stocks, cryptocurrency, and several luxury cars while still squirreling away over $6 million in his personal bank account.
Zishan Alvi, 45, of Inverness, Illinois, co-owned LabElite, which federal prosecutors say billed the federal government for COVID-19 tests that were either never performed or were performed with purposefully inadequate components to render them futile. Customers who sought testing from LabElite—sometimes for clearance to travel or have contact with vulnerable people—received either no results or results indicating they were negative for the deadly virus.
The scam, which ran from around February 2021 to about February 2022, made over $83 million total in fraudulent payments from the federal government’s Health Resources and Services Administration (HRSA), which covered the cost of COVID-19 testing for people without insurance during the height of the pandemic. Local media coverage indicated that people who sought testing at LabElite were discouraged from providing health insurance information.
The list included five vehicles: a 2021 Mercedes-Benz, a 2021 Land Rover Range Rover HSE, a 2021 Lamborghini Urus, A 2021 Bentley, and a 2022 Tesla X. There was also about $810,000 in an E*Trade account, approximately $500,000 in a Fidelity Investments account, and $245,814 in a Coinbase account. Last, there was $6,825,089 in Alvi’s personal bank account.
On Monday, the Department of Justice announced a deal in which Alvi pleaded guilty to one count of wire fraud, taking responsibility for $14 million worth of fraudulent HRSA claims. He now faces up to 20 years in prison and will be sentenced on February 7, 2025.
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.
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.
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.
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.
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.
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.
Four years after the outbreak of the COVID-19 pandemic, doctors and researchers are still seeking ways to help patients with long COVID, the persistent and often debilitating symptoms that can continue long after a COVID-19 infection.
In adults, the most common long COVID symptoms include fatigue and brain fog, but for children the condition can look different. A study published last month suggests preteens are more likely to experience symptoms such as headaches, stomach pain, trouble sleeping, and attention difficulties. Even among children, effects seem to vary by age. “There seems to be some differences between age groups, with less signs of organ damage in younger children and more adultlike disease in adolescents,” says Petter Brodin, professor of pediatric immunology at Imperial College London.
While vast sums have been devoted to long COVID research—the US National Institutes of Health have spent more than a billion dollars on research projects and clinical trials—research into children with the condition has been predominantly limited to online surveys, calls with parents, and studies of electronic health records. This is in spite of a recent study suggesting that between 10 and 20 percent of children may have developed long COVID following an acute infection, and another report finding that while many have recovered, some still remain ill three years later.
Now, what’s believed to be the first clinical trial specifically aimed at children and young adults with long COVID is underway, recruiting subjects aged 7 to 21 on which to test a potential treatment. It builds on research that suggests long COVID in children may be linked to the gut.
In May 2021, Lael Yonker, a pediatric pulmonologist at Massachusetts General Hospital in Boston, published a study of multisystem inflammatory syndrome in children (MIS-C), which she says is now regarded as a more severe and acute version of long COVID. It showed that these children had elevated levels of a protein called zonulin, a sign of a so-called leaky gut. Higher levels of zonulin are associated with greater permeability in the intestine, which could enable SARS-CoV-2 viral particles to leak out of the intestines and into the bloodstream instead of being excreted out of the body. From there, they could trigger inflammation.
As Yonker began to see more and more children with long COVID, she theorized that many of the gastrointestinal and neurological symptoms they were experiencing might be linked. But her original study also pointed to a possible solution. When she gave the children with MIS-C a drug called larazotide, an existing treatment for people with issues relating to a leaky gut, the levels of viral particles in their blood decreased and their symptoms improved.
Enlarge/ A warning sign outside a laboratory testing the H5N1 bird flu virus at The Pirbright Institute in Woking, UK, on Monday, March 13, 2023.
More than a month after a person in Missouri mysteriously fell ill with H5-type bird flu, investigators in the state are still identifying people who became ill after contact with the patient, raising questions about the diligence of the ongoing health investigation.
On September 6, Missouri’s health department reported the state’s first human case of H5-type bird flu, one that appears closely related to the H5N1 bird flu currently causing a nationwide outbreak among dairy cows. But the infected person had no known contact with infected animals—unlike all of the other 13 human cases identified amid the dairy outbreak this year. Those previous cases have all occurred in dairy- or poultry-farm workers. In fact, Missouri has not reported bird flu in its dairy herds nor recent poultry outbreaks.
Given the unexplained source of infection, health investigators in the state have been working to track the virus both backward in time—to try to identify the source—and forward—to identify any potential onward spread. The bird flu patient was initially hospitalized on August 22 but recovered and had been released by the time the state publicly reported the case.
In an update Friday, September 27, the Centers for Disease Control and Prevention relayed that Missouri officials have now identified four more health care workers who experienced mild respiratory illnesses after caring for the person with bird flu. None of the four workers were tested for flu at the time of their illnesses and all have since recovered.
Testing new cases for antibodies to H5N1
The four newly identified cases bring the total number of health care workers who fell ill after contact to six. Missouri investigators had previously identified two other health care workers who developed mild respiratory symptoms. One of those workers was tested for flu around the time of their illness—and tested negative. But the other, like the four newly identified cases, was not tested. That person has since submitted a blood sample to test for bird flu antibodies, which would indicate a previous infection.
In addition, a household contact of the bird flu patient also fell ill at the same time as the patient, suggesting a possible common source of the infection.
The illnesses are concerning, given the fear that H5N1 bird flu could begin spreading from human to human and spark a widespread outbreak or even a pandemic. However, it can’t be overlooked that a plethora of other respiratory viruses are around—and SARS-CoV-2 transmission was relatively high in Missouri at the time—it’s impossible to draw any conclusions at this point about whether the illnesses were bird flu infections.
But, the illnesses do clearly raise concern about the health investigation, which is being conducted by Missouri officials. “The slow trickle of info is the most concerning part,” infectious disease expert Krutika Kuppalli wrote on social media Friday. The CDC can get involved at the request of a state, but such a request has not been made. For now, the CDC is only providing technical assistance from Atlanta.
In its update today, the CDC emphasized that “to date, only one case of influenza A(H5N1) has been detected in Missouri. No contacts of that case have tested positive for influenza A(H5N1).” The agency added that blood testing results for H5 antibodies are pending.
