Kaiser Health News

Toxic Gas That Sterilizes Medical Devices Prompts Safety Rule Update

Published

3 months ago

February 29, 2024

Andy Miller and Sam Whitehead
Thu, 29 Feb 2024 10:00:00 +0000

Over the past two years, Madeline Beal has heard frustration and even bewilderment during public meetings about ethylene oxide, a cancer-causing gas that is used to sterilize half of the medical devices in the U.S.

Beal, senior risk communication adviser for the Environmental Protection Agency, has fielded questions about why the agency took so long to alert people who live near facilities that emit the chemical about unusually high amounts of the carcinogenic gas in their neighborhoods. Residents asked why the EPA couldn't close those facilities, and they wanted to know how many people had developed cancer from their exposure.

“If you're upset by the information you're hearing tonight, if you're angry, if it scares you to think about risk to your family, those are totally reasonable responses,” Beal told an audience in Laredo, Texas, in September 2022. “We think the risk levels near this facility are too high.”

There are about 90 sterilizing plants in the U.S. that use ethylene oxide, and for decades companies used the chemical to sterilize medical products without drawing much attention. Many medical device-makers send their products to the plants to be sterilized before they are shipped, typically to medical distribution companies.

But people living around these facilities have been jolted in recent years by a succession of warnings about cancer risk from the federal government and media reports, an awareness that has also spawned protests and lawsuits alleging medical harm.

The EPA is expected to meet a March 1 court-ordered deadline to finalize tighter safety rules around how the toxic gas is used. The proposed changes come in the wake of a 2016 agency report that found that long-term exposure to ethylene oxide is more dangerous than was previously thought.

But the anticipated final rules — the agency's first regulatory update on ethylene oxide emissions in more than a decade — are expected to face pushback. Medical device-makers worry stricter regulation will increase costs and may put patients at higher risk of infection from devices, ranging from surgical kits to catheters, due to deficient sterilization. The new rules are also not likely to satisfy the concerns of environmentalists or members of the public, who already have expressed frustration about how long it took the federal government to sound the alarm.

“We have been breathing this air for 40 years,” said Connie Waller, 70, who lives with her husband, David, 75, within two miles of such a sterilizing plant in Covington, Georgia, east of Atlanta. “The only way to stop these chemicals is to hit them in their pocketbook, to get their attention.”

The EPA says data shows that long-term exposure to ethylene oxide can increase the risk of breast cancer and cancers of the white blood cells, such as non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia. It can irritate the eyes, nose, throat, and lungs, and has been linked to damage to the brain and nervous and reproductive systems. Children are potentially more vulnerable, as are workers routinely exposed to the chemical, EPA officials say. The agency calculates the risk based on how much of the gas is in the air or near the sterilizing facility, the distance a person is from the plant, and how long the person is exposed.

Waller said she was diagnosed with breast cancer in 2004 and that her husband was found to have non-Hodgkin lymphoma eight years later.

A 2022 study of communities living near a sterilization facility in Laredo found the rates of acute lymphocytic leukemia and breast cancer were statistically significant, greater than expected compared with statewide rates.

Beal, the EPA risk adviser, who regularly meets with community members, acknowledges the public's concerns. “We don't think it's OK for you to be at increased risk from something that you have no control over, that's near your house,” she said. “We are working as fast as we can to get that risk reduced with the powers that we have available to us.”

In the meantime, local and state governments and industry groups have scrambled to defuse public outcry.

Hundreds of personal injury cases have been filed in communities near sterilizing plants. In 2020, New Mexico's then-attorney general filed a lawsuit against a plant in Santa Teresa, and that case is ongoing. In a case that settled last year in suburban Atlanta, a company agreed to pay $35 million to 79 people who alleged ethylene oxide used at the plant caused cancer and other injuries.

In Cook County, Illinois, a jury in 2022 awarded $363 million to a woman who alleged exposure to ethylene oxide gas led to her breast cancer diagnosis. But, in another Illinois case, a jury ruled that the sterilizing company was not liable for a woman's blood cancer claim.

Greg Crist, chief advocacy officer for the Advanced Medical Technology Association, a medical device trade group that says ethylene oxide is an effective and reliable sterilant, attributes the spate of lawsuits to the litigious nature of trial attorneys.

“If they smell blood in the water, they'll go after it,” Crist said.

Most states have at least one sterilizing plant. According to the EPA, a handful, like California and North Carolina, have gone further than the agency and the federal Clean Air Act to regulate ethylene oxide emissions. After a media and political firestorm raised awareness about the metro Atlanta facilities, Georgia started requiring sterilizing plants that use the gas to report all leaks.

The proposed rules the EPA is set to finalize would set lower emissions limits for chemical plants and commercial sterilizers and increase some safety requirements for workers within these facilities. The agency is expected to set an 18-month deadline for commercial sterilizers to come into compliance with the emissions rules.

That would help at facilities that “cut corners,” with lax pollution controls that allow emissions of the gas into nearby communities, said Richard Peltier, a professor of environmental health sciences at the University of Massachusetts-Amherst. Stronger regulation also prevents the plants from remaining under the radar. “One of the dirty secrets is that a lot of it is self-regulated or self-policed,” Peltier added.

But the proposed rules did not include protections for workers at off-site warehouses that store sterilized products, which can continue to emit ethylene oxide. They also did not require air testing around the facilities, prompting debate about how effective they would be in protecting the health of nearby residents.

Industry officials also don't expect an alternative that is as broadly effective as ethylene oxide to be developed anytime soon, though they support researching other methods. Current alternatives include steam, radiation, and hydrogen peroxide vapor.

Increasing the use of alternatives can reduce industry dependence on “the crutch of ethylene oxide,” said Darya Minovi, senior analyst with the Union of Concerned Scientists, an advocacy group.

But meeting the new guidelines will be disruptive to the industry, Crist said. He estimates companies will spend upward of $500 million to comply with the new EPA rules and could struggle to meet the agency's 18-month timetable. Sterilization companies will also have difficulty adjusting to new rules on how workers handle the gas without a dip in efficiency, Crist said.

The Food and Drug Administration, which regulates drugs and medical devices, is also watching the regulatory moves closely and worries the updated emissions rule could “present some unique challenges” if implemented as proposed, said Audra Harrison, an FDA spokesperson. “The FDA is concerned about the rule's effects on the availability of medical devices,” she added.

Other groups, like the American Chemistry Council and the Texas Commission on Environmental Quality, the state's environmental agency, assert that ethylene oxide use isn't as dangerous as the EPA says. The EPA's toxicity assessment has “severe flaws” and is “overly conservative,” the council said in an emailed statement. Texas, which has several sterilizing plants, has said ethylene oxide isn't as high a cancer risk as the agency claims, an assessment that the EPA has rejected.

Tracey Woodruff, a researcher at the University of California-San Francisco who previously worked at the EPA, said it can be hard for the agency to keep up with regulating chemicals like ethylene oxide because of constrained resources, the technical complications of rulemaking, and industry lobbying.

But she's hopeful the EPA can strike a balance between its desire to reduce exposure and the desire of the FDA not to disrupt medical device sterilization. And scrutiny can also help the device sterilization industry think outside the box.

“We continue to discover these chemicals that we've already been exposed to were toxic, and we have high exposures,” she said. “Regulation is an innovation forcer.”

——————————
By: Andy Miller and Sam Whitehead
Title: Toxic Gas That Sterilizes Medical Devices Prompts Safety Rule Update
Sourced From: kffhealthnews.org/news/article/ethylene-oxide-carcinogen-sterilizer-medical-devices-epa-regulation/
Published Date: Thu, 29 Feb 2024 10:00:00 +0000

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The Chicken and Egg Problem of Fighting Another Flu Pandemic

Published

20 hours ago

May 31, 2024

Staff Editor

Arthur Allen
Fri, 31 May 2024 09:00:00 +0000

Even a peep of news about a new flu pandemic is enough to set scientists clucking about eggs.

They worried about them in 2005, and in 2009, and they're worrying now. That's because millions of fertilized hen eggs are still the main ingredient in making vaccines that, hopefully, will protect people against the outbreak of a new flu strain.

“It's almost comical to be using a 1940s technology for a 21st-century pandemic,” said Rick Bright, who led the Health and Human Services Department's Biomedical Advanced Research and Development Authority (BARDA) during the Trump administration.

It's not so funny, he said, when the currently stockpiled formulation against the H5N1 bird flu virus requires two shots and a whopping 90 micrograms of antigen, yet provides just middling immunity. “For the U.S. alone, it would take hens laying 900,000 eggs every single day for nine months,” Bright said.

And that's only if the chickens don't get infected.

The spread of an avian flu virus has decimated flocks of birds (and killed barn cats and other mammals). Cattle in at least nine states and at least three people in the U.S. have been infected, enough to bring public health attention once again to the potential for a global pandemic.

As of May 30, the only confirmed human cases of infection were dairy workers in Texas and Michigan, who experienced eye irritation. Two quickly recovered, while the third developed respiratory symptoms and was being treated with an antiviral drug at home. The virus's spread into multiple species over a vast geographic area, however, raises the threat that further mutations could create a virus that spreads from human to human through airborne transmission.

If they do, prevention starts with the egg.

To make raw material for an influenza vaccine, virus is grown in millions of fertilized eggs. Sometimes it doesn't grow well, or it mutates to a degree that the vaccine product stimulates antibodies that don't neutralize the virus — or the wild virus mutates to an extent that the vaccine doesn't work against it. And there's always the frightening prospect that wild birds could carry the virus into the henhouses needed in vaccine production.

“Once those roosters and hens go down, you have no vaccine,” Bright said.

Since 2009, when an H1N1 swine flu pandemic swept around the world before vaccine production could get off the ground, researchers and governments have been looking for alternatives. Billions of dollars have been invested into vaccines produced in mammalian and insect cell lines that don't pose the same risks as egg-based shots.

“Everyone knows the cell-based vaccines are better, more immunogenic, and offer better production,” said Amesh Adalja, an infectious disease specialist at Johns Hopkins University's Center for Health Security. “But they are handicapped because of the clout of egg-based manufacturing.”

The companies that make the cell-based influenza vaccines, CSL Seqirus and Sanofi, also have billions invested in egg-based production lines that they aren't eager to replace. And it's hard to blame them, said Nicole Lurie, HHS' assistant secretary for preparedness and response under President Barack Obama who is now an executive director of CEPI, the global epidemic-fighting nonprofit.

“Most vaccine companies that responded to an epidemic — Ebola, Zika, covid — ended up losing a lot of money on it,” Lurie said.

Exceptions were the mRNA vaccines created for covid, although even Pfizer and Moderna have had to destroy hundreds of millions of doses of unwanted vaccine as public interest waned.

Pfizer and Moderna are testing seasonal influenza vaccines made with mRNA, and the government is soliciting bids for mRNA pandemic flu vaccines, said David Boucher, director of infectious disease preparedness at HHS' Administration for Strategic Preparedness and Response.

Bright, whose agency invested a billion dollars in a cell-based flu vaccine factory in Holly Springs, North Carolina, said there's “no way in hell we can fight an H5N1 pandemic with an egg-based vaccine.” But for now, there's little choice.

BARDA has stockpiled hundreds of thousands of doses of an H5N1-strain vaccine that stimulates the creation of antibodies that appear to neutralize the virus now circulating. It could produce millions more doses of the vaccine within weeks and up to 100 million doses in five months, Boucher told KFF Health News.

But the vaccines currently in the national stockpile are not a perfect match for the strain in question. Even with two shots containing six times as much vaccine substance as typical flu shots, the stockpiled vaccines were only partly effective against strains of the virus that circulated when those vaccines were made, Adalja said.

However, BARDA is currently supporting two clinical trials with a candidate vaccine virus that “is a good match for what we've found in cows,” Boucher said.

Flu vaccine makers are just starting to prepare this fall's shots but, eventually, the federal government could request production be switched to a pandemic-targeted strain.

“We don't have the capacity to do both,” Adalja said.

For now, ASPR has a stockpile of bulk pandemic vaccine and has identified manufacturing sites where 4.8 million doses could be bottled and finished without stopping production of seasonal flu vaccine, ASPR chief Dawn O'Connell said on May 22. U.S. officials began trying to diversify away from egg-based vaccines in 2005, when avian flu first gripped the world, and with added vigor after the 2009 fiasco. But “with the resources we have available, we get the best bang for our buck and best value to U.S. taxpayers when we leverage the seasonal infrastructure, and that's still mostly egg-based,” Boucher said.

Flu vaccine companies “have a system that works well right now to accomplish their objectives in manufacturing the seasonal vaccine,” he said. And without a financial incentive, “we are going to be here with eggs for a while, I think.”

——————————
By: Arthur Allen
Title: The Chicken and Egg Problem of Fighting Another Flu Pandemic
Sourced From: kffhealthnews.org/news/article/bird-flu-potential-pandemic-vaccine-chicken-egg-quandary/
Published Date: Fri, 31 May 2024 09:00:00 +0000

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Kaiser Health News

After Grilling an NIH Scientist Over Covid Emails, Congress Turns to Anthony Fauci

Published

22 hours ago

May 31, 2024

Staff Editor

David Hilzenrath
Fri, 31 May 2024 09:00:00 +0000

Former National Institutes of Health official Anthony Fauci has faced many hostile questions from members of Congress, but when he appears before a House panel on Monday, he'll have something new to answer for: a trove of incendiary emails written by one of his closest advisers.

In the emails, David Morens, a career federal scientist now on administrative leave, described deleting messages and using a personal email account to evade disclosure of correspondence under the Freedom of Information Act.

“i learned from our foia lady here how to make emails disappear after i am foia'd but before the search starts, so i think we are all safe,” Morens wrote in a Feb. 24, 2021, email. “Plus i deleted most of those earlier emails after sending them to gmail.”

The pressure is on as Fauci himself prepares to appear June 3 before a House subcommittee exploring the origins of covid-19. The NIH, a $49 billion agency that is the foremost source of funding in the world for biomedical research, finds itself under unusual bipartisan scrutiny. The subcommittee has demanded more outside oversight of NIH and its 50,000 grants and raised the idea of term limits for officials like Fauci, who led the National Institute of Allergy and Infectious Diseases, an NIH component, from 1984 to 2022.

Lawmakers are likely to put Fauci on the spot about Morens' emails at a time when Republicans are questioning NIH's credibility and integrity. Even Democrats have cautioned the agency's leaders.

“When people don't trust scientists, they don't trust the science,” Rep. Deborah Ross (D-N.C.) told Morens.

The subcommittee has yet to turn up evidence implicating the NIH or U.S. scientists in the pandemic's beginnings in Wuhan, China. Nor has its work shed light on the origin of the virus.

But in a May 28 letter to NIH Director Monica Bertagnolli, the subcommittee's chairman, Rep. Brad Wenstrup (R-Ohio), said the evidence “suggests a conspiracy at the highest levels of NIH and NIAID to avoid public transparency regarding the COVID-19 pandemic.”

Rep. Jill Tokuda, a subcommittee Democrat from Hawaii, said the evidence shows no such conspiracy. She predicted the bipartisan criticism of Morens, 76, will give way to “a clash of intentions” at the hearing as Republicans try to pin covid on Fauci.

“For them, I think this is their moment to, again, bring a lot of these baseless, false allegations to the front,” Tokuda said.

On May 29, Wenstrup asked Fauci to turn over personal e-mails ahead of his testimony.

Here are things to know as the subcommittee gears up for Fauci's appearance.

What Is the Subcommittee Looking For?

The Select Subcommittee on the Coronavirus Pandemic is supposed to be investigating how the pandemic started and the federal government's response. That includes such hot-button issues as vaccination policies and school closures.

A central question is whether the covid virus leaped from animals to humans at a market in Wuhan, China, or spread from a leak at the nearby Wuhan Institute of Virology. The Wuhan lab received funding from an NIH grant recipient called EcoHealth Alliance.

The congressional probe is in some ways an extension of the nation's political, cultural, and scientific battles arising from the pandemic.

The Republican-led subcommittee has been examining NIH's performance and that of Fauci, who advised both former President Donald Trump and President Joe Biden, becoming the face of many of the government's most polarizing pandemic policies.

The panel called for the government to cut off EcoHealth's funding, a process the Department of Health and Human Services recently initiated.

EcoHealth's president, Peter Daszak, was Morens' friend and the recipient of many of the emails under scrutiny. A wildlife biologist credited with helping to develop the first covid antiviral drug, remdesivir, Daszak said he and his organization did nothing wrong.

“We were so accurate in our predictions that a bat coronavirus would emerge from China and cause a pandemic, that when it did, we're dragged in front of the crowd with their pitchforks and blamed for it,” Daszak said in an interview.

What's at Stake for NIH?

The Republican-led subcommittee is challenging NIH's credibility. The agency performs and funds a wide variety of medical and scientific research, work that is often the foundation of new medicines and other treatments, and has long enjoyed bipartisan support from Congress. The agency is home to the “Cancer Moonshot,” a Biden priority.

As head of NIAID and a presidential adviser, Fauci helped guide the public during the pandemic on measures to avoid infection, such as mask-wearing and maintaining physical distance.

But at a May 22 hearing, Wenstrup said Fauci's NIAID “was, unfortunately, less pristine than so many, including the media, would have had us all believe.”

In his letter to Bertagnolli, Wenstrup said there was evidence that a former chief of staff of Fauci's might have used intentional misspellings — such as a variant of “EcoHealth” — to prevent emails from being captured in keyword searches by FOIA officials.

Wenstrup's office did not respond to questions or an interview request.

An aide to the top Democrat on the subcommittee, Rep. Raul Ruiz of California, said he was unavailable for an interview.

Why Were Morens' Emails Alarming?

The emails show a pattern of trying to shield communications from public disclosure.

“We are all smart enough to know to never have smoking guns, and if we did we wouldn't put them in emails, and if we found them we'd delete them,” Morens wrote on June 16, 2020.

“The best way to avoid FOIA hassles is to delete all emails when you learn a subject is getting sensitive,” he wrote on June 28, 2021.

Some of Morens' emails included sexual or sexist remarks, including one from December 2020: “Beverage is always good, and best delivered by a blonde nymphomaniac.” In another email, discussing how former Centers for Disease Control and Prevention Director Rochelle Walensky got her job, he remarked, “Well, she does wear a skirt.”

Morens apologized at the May 22 hearing and called some of what he wrote “misogynistic.”

“Some of the emails I've seen that you all have provided look pretty incriminating,” he testified.

Asked if he ever sent information related to covid to Fauci's personal email, he said he didn't remember but might have.

Morens said some of his comments were “snarky jokes” intended to cheer up his friend Daszak, the EcoHealth president, who was receiving death threats over media coverage of his organization's relationship with the Wuhan lab.

Morens testified that he didn't knowingly delete official records.

Ross, the North Carolina representative, said the emails “inflict serious damage on public trust for the entire scientific enterprise.” She said the dangers can be seen in eroding public confidence in vaccines, contributing to recent outbreaks of measles.

Rep. Debbie Dingell (D-Mich.) said Morens showed disdain for the Freedom of Information Act. The subcommittee's investigation has been an unfounded effort to pin the blame for the pandemic on NIH and NIAID, and Morens' emails have helped blur the issues, she said.

Do the Emails Reveal the Origins of Covid?

No, as Democrats have emphasized.

In a way, Morens' correspondence undercuts allegations that people at the top of NIAID covered up a lab leak in Wuhan.

None of Morens' emails describe any effort to suppress evidence of a lab leak and, in an email sent from a private account, he ridiculed the idea, calling it “false to the point of being crazy.” But the subcommittee's senior Democrat, Ruiz, criticized Morens for dismissing the lab leak theory.

“Unless and until we see specific evidence on the origins” of the virus that causes covid, “the scientific process requires that we examine all possible hypotheses with objectivity,” Ruiz said.

KFF Health News senior correspondent Arthur Allen contributed to this report.

——————————
By: David Hilzenrath
Title: After Grilling an NIH Scientist Over Covid Emails, Congress Turns to Anthony Fauci
Sourced From: kffhealthnews.org/news/article/nih-scientist-covid-emails-congress-anthony-fauci-hearing/
Published Date: Fri, 31 May 2024 09:00:00 +0000

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Kaiser Health News

KFF Health News’ ‘What the Health?’: Waiting for SCOTUS

Published

2 days ago

May 30, 2024

Staff Editor

Thu, 30 May 2024 18:45:00 +0000

The Host

Julie Rovner
KFF Health News

@jrovner

Read Julie's stories.

Julie Rovner is chief Washington correspondent and host of KFF Health News' weekly health policy news podcast, “What the Health?” A noted expert on health policy issues, Julie is the author of the critically praised reference book “Health Care Politics and Policy A to Z,” now in its third edition.

June means it's time for the Supreme Court to render rulings on the biggest and most controversial cases of the term. This year, the court has two significant abortion-related cases: one involving the abortion pill mifepristone and the other regarding the conflict between a federal emergency care law and Idaho's near-total abortion ban.

Also awaiting resolution is a case that could dramatically change how the federal government makes health care (and all other types of) policies by potentially limiting agencies' authority in interpreting the details of laws through regulations. Rules stemming from the Affordable Care Act and other legislation could be affected.

In this special episode of “What the Health?”, Laurie Sobel, an associate director for women's health policy at KFF, joins host Julie Rovner for a refresher on the cases, and a preview of how the justices might rule on them.

The cases highlighted in this episode:

Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce, about how much discretion federal agencies should have in interpreting laws passed by Congress.
U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, about whether the FDA exceeded its authority in relaxing restrictions on the abortion pill mifepristone.
Moyle v. United States and Idaho v. United States, about whether the federal Emergency Medical Treatment and Labor Act requirement for hospitals participating in Medicare to provide needed medical care overrides Idaho's near-total abortion ban in emergency cases.

Previous “What the Health?” coverage of these cases:

Where to find Supreme Court opinions as they are announced:

The Supreme Court's official website
The SCOTUSblog (not an official government website but run by lawyers and journalists)

Credits

Francis Ying
Audio producer

Rebecca Adams
Editor

To hear all our podcasts, click here.

And subscribe to KFF Health News' “What the Health?” on Spotify, Apple Podcasts, Pocket Casts, or wherever you listen to podcasts.

——————————
Title: KFF Health News' ‘What the Health?': Waiting for SCOTUS
Sourced From: kffhealthnews.org/news/podcast/what-the-health-349-supreme-court-abortion-cases-may-30-2024/
Published Date: Thu, 30 May 2024 18:45:00 +0000

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