Connect with us

Government

PFAS ‘forever chemicals’ are widespread and threaten human health – here’s a strategy for protecting the public

PFAS ‘forever chemicals’ are widespread and threaten human health – here’s a strategy for protecting the public

Published

on

Firefighting foam left after a fire in Pennsylvania. These foams often contain PFAS chemicals that can contaminate water supplies. Bastiaan Slabbers/NurPhoto via Getty Images

Like many inventions, the discovery of Teflon happened by accident. In 1938, chemists from Dupont (now Chemours) were studying refrigerant gases when, much to their surprise, one concoction solidified. Upon investigation, they found it was not only the slipperiest substance they’d ever seen – it was also noncorrosive and extremely stable and had a high melting point.

In 1954 the revolutionary “nonstick” Teflon pan was introduced. Since then, an entire class of human-made chemicals has evolved: per- and polyfluoroalkyl substances, better known as PFAS. There are upward of 6,000 of these chemicals. Many are used for stain-, grease- and waterproofing. PFAS are found in clothing, plastic, food packaging, electronics, personal care products, firefighting foams, medical devices and numerous other products.

But over time, evidence has slowly built that some commonly used PFAS are toxic and may cause cancer. It took 50 years to understand that the happy accident of Teflon’s discovery was, in fact, a train wreck.

As a public health analyst, I have studied the harm caused by these chemicals. I am one of hundreds of scientists who are calling for a comprehensive, effective plan to manage the entire class of PFAS to protect public health while safer alternatives are developed.

Typically, when the U.S. Environmental Protection Agency assesses chemicals for potential harm, it examines one substance at a time. That approach isn’t working for PFAS, given the sheer number of them and the fact that manufacturers commonly replace toxic substances with “regrettable substitutes” – similar, lesser-known chemicals that also threaten human health and the environment.

Graphic showing how PFAS moves from many sources into soil and water
As PFAS are produced and used, they can migrate into soil and water. MI DEQ

Toxic chemicals

A class-action lawsuit brought this issue to national attention in 2005. Workers at a Parkersburg, West Virginia, DuPont plant joined with local residents to sue the company for releasing millions of pounds of one of these chemicals, known as PFOA, into the air and the Ohio River. Lawyers discovered that the company had known as far back as 1961 that PFOA could harm the liver.

The suit was ultimately settled in 2017 for US$670 million, after an eight-year study of tens of thousands of people who had been exposed. Based on multiple scientific studies, this review concluded that there was a probable link between exposure to PFOA and six categories of diseases: diagnosed high cholesterol, ulcerative colitis, thyroid disease, testicular cancer, kidney cancer and pregnancy-induced hypertension.

Over the past two decades, hundreds of peer-reviewed scientific papers have shown that many PFAS are not only toxic – they also don’t fully break down in the environment and have accumulated in the bodies of people and animals around the world. Some studies have detected PFAS in 99% of people tested. Others have found PFAS in wildlife, including polar bears, dolphins and seals.

Attorney Robert Billott describes suing Dupont for knowingly releasing millions of pounds of hazardous PFOA in Parkersburg, West Virginia.

Widespread and persistent

PFAS are often called “forever chemicals” because they don’t fully degrade. They move easily through air and water, can quickly travel long distances and accumulate in sediment, soil and plants. They have also been found in dust and food, including eggs, meat, milk, fish, fruits and vegetables.

In the bodies of humans and animals, PFAS concentrate in various organs, tissues and cells. The U.S. National Toxicology Program and Centers for Disease Control and Prevention have confirmed a long list of health risks, including immunotoxicity, testicular and kidney cancer, liver damage, decreased fertility and thyroid disease.

Children are even more vulnerable than adults because they can ingest more PFAS relative to their body weight from food and water and through the air. Children also put their hands in their mouths more often, and their metabolic and immune systems are less developed. Studies show that these chemicals harm children by causing kidney dysfunction, delayed puberty, asthma and altered immune function.

Researchers have also documented that PFAS exposure reduces the effectiveness of vaccines, which is particularly concerning amid the COVID-19 pandemic.

Regulation is lagging

PFAS have become so ubiquitous in the environment that health experts say it is probably impossible to completely prevent exposure. These substances are released throughout their life cycles, from chemical production to product use and disposal. Up to 80% of environmental pollution from common PFAS, such as PFOA, comes from production of fluoropolymers that use toxic PFAS as processing aids to make products like Teflon.

In 2009 the EPA established a health advisory level for PFOA in drinking water of 400 parts per trillion. Health advisories are not binding regulations – they are technical guidelines for state, local and tribal governments, which are primarily responsible for regulating public water systems.

In 2016 the agency dramatically lowered this recommendation to 70 parts per trillion. Some states have set far more protective levels – as low as 8 parts per trillion.

According to a recent estimate by the Environmental Working Group, a public health advocacy organization, up to 110 million Americans could be drinking PFAS-contaminated water. Even with the most advanced treatment processes, it is extremely difficult and costly to remove these chemicals from drinking water. And it’s impossible to clean up lakes, river systems or oceans. Nonetheless, PFAS are largely unregulated by the federal government, although they are gaining increased attention from Congress.

Water treatment tanks
Part of a filtration system designed to remove PFAS from drinking water, Horsham Water and Sewer Authority, Horsham, Pennsylvania. Bastiaan Slabbers/NurPhoto via Getty Images

Reducing PFAS risks at the source

Given that PFAS pollution is so ubiquitous and hard to remove, many health experts assert that the only way to address it is by reducing PFAS production and use as much as possible.

Educational campaigns and consumer pressure are making a difference. Many forward-thinking companies, including grocers, clothing manufacturers and furniture stores, have removed PFAS from products they use and sell.

[Understand new developments in science, health and technology, each week. Subscribe to The Conversation’s science newsletter.]

State governments have also stepped in. California recently banned PFAS in firefighting foams. Maine and Washington have banned PFAS in food packaging. Other states are considering similar measures.

I am part of a group of scientists from universities, nonprofit organizations and government agencies in the U.S. and Europe that has argued for managing the entire class of PFAS chemicals as a group, instead of one by one. We also support an “essential uses” approach that would restrict their production and use only to products that are critical for health and proper functioning of society, such as medical devices and safety equipment. And we have recommended developing safer non-PFAS alternatives.

As the EPA acknowledges, there is an urgent need for innovative solutions to PFAS pollution. Guided by good science, I believe we can effectively manage PFAS to reduce further harm, while researchers find ways to clean up what has already been released.

Carol Kwiatkowski has worked for two nonprofit organizations that receive foundation funding: The Endocrine Disruption Exchange and the Green Science Policy Institute.

Read More

Continue Reading

Government

Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide…

Published

on

Glimpse Of Sanity: Dartmouth Returns Standardized Testing For Admission After Failed Experiment

In response to the virus pandemic and nationwide Black Lives Matter riots in the summer of 2020, some elite colleges and universities shredded testing requirements for admission. Several years later, the test-optional admission has yet to produce the promising results for racial and class-based equity that many woke academic institutions wished.

The failure of test-optional admission policies has forced Dartmouth College to reinstate standardized test scores for admission starting next year. This should never have been eliminated, as merit will always prevail. 

"Nearly four years later, having studied the role of testing in our admissions process as well as its value as a predictor of student success at Dartmouth, we are removing the extended pause and reactivating the standardized testing requirement for undergraduate admission, effective with the Class of 2029," Dartmouth wrote in a press release Monday morning. 

"For Dartmouth, the evidence supporting our reactivation of a required testing policy is clear. Our bottom line is simple: we believe a standardized testing requirement will improve—not detract from—our ability to bring the most promising and diverse students to our campus," the elite college said. 

Who would've thought eliminating standardized tests for admission because a fringe minority said they were instruments of racism and a biased system was ever a good idea? 

Also, it doesn't take a rocket scientist to figure this out. More from Dartmouth, who commissioned the research: 

They also found that test scores represent an especially valuable tool to identify high-achieving applicants from low and middle-income backgrounds; who are first-generation college-bound; as well as students from urban and rural backgrounds.

All the colleges and universities that quickly adopted test-optional admissions in 2020 experienced a surge in applications. Perhaps the push for test-optional was under the guise of woke equality but was nothing more than protecting the bottom line for these institutions. 

A glimpse of sanity returns to woke schools: Admit qualified kids. Next up is corporate America and all tiers of the US government. 

Tyler Durden Mon, 02/05/2024 - 17:20

Read More

Continue Reading

International

Four burning questions about the future of the $16.5B Novo-Catalent deal

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.
Beyond spending billions of dollars to expand…

Published

on

To build or to buy? That’s a classic question for pharma boardrooms, and Novo Nordisk is going with both.

Beyond spending billions of dollars to expand its own production capacity for its weight loss drugs, the Danish drugmaker said Monday it will pay $11 billion to acquire three manufacturing plants from Catalent. It’s part of a broader $16.5 billion deal with Novo Holdings, the investment arm of the pharma’s parent group, which agreed to acquire the contract manufacturer and take it private.

It’s a big deal for all parties, with potential ripple effects across the biotech ecosystem. Here’s a look at some of the most pressing questions to watch after Monday’s announcement.

Why did Novo do this?

Novo Holdings isn’t the most obvious buyer for Catalent, particularly after last year’s on-and-off M&A interest from the serial acquirer Danaher. But the deal could benefit both Novo Holdings and Novo Nordisk.

Novo Nordisk’s biggest challenge has been simply making enough of the weight loss drug Wegovy and diabetes therapy Ozempic. On last week’s earnings call, Novo Nordisk CEO Lars Fruergaard Jørgensen said the company isn’t constrained by capital in its efforts to boost manufacturing. Rather, the main challenge is the limited amount of capabilities out there, he said.

“Most pharmaceutical companies in the world would be shopping among the same manufacturers,” he said. “There’s not an unlimited amount of machinery and people to build it.”

While Novo was already one of Catalent’s major customers, the manufacturer has been hamstrung by its own balance sheet. With roughly $5 billion in debt on its books, it’s had to juggle paying down debt with sufficiently investing in its facilities. That’s been particularly challenging in keeping pace with soaring demand for GLP-1 drugs.

Novo, on the other hand, has the balance sheet to funnel as much money as needed into the plants in Italy, Belgium, and Indiana. It’s also struggled to make enough of its popular GLP-1 drugs to meet their soaring demand, with documented shortages of both Ozempic and Wegovy.

The impact won’t be immediate. The parties expect the deal to close near the end of 2024. Novo Nordisk said it expects the three new sites to “gradually increase Novo Nordisk’s filling capacity from 2026 and onwards.”

As for the rest of Catalent — nearly 50 other sites employing thousands of workers — Novo Holdings will take control. The group previously acquired Altasciences in 2021 and Ritedose in 2022, so the Catalent deal builds on a core investing interest in biopharma services, Novo Holdings CEO Kasim Kutay told Endpoints News.

Kasim Kutay

When asked about possible site closures or layoffs, Kutay said the team hasn’t thought about that.

“That’s not our track record. Our track record is to invest in quality businesses and help them grow,” he said. “There’s always stuff to do with any asset you own, but we haven’t bought this company to do some of the stuff you’re talking about.”

What does it mean for Catalent’s customers? 

Until the deal closes, Catalent will operate as a standalone business. After it closes, Novo Nordisk said it will honor its customer obligations at the three sites, a spokesperson said. But they didn’t answer a question about what happens when those contracts expire.

The wrinkle is the long-term future of the three plants that Novo Nordisk is paying for. Those sites don’t exclusively pump out Wegovy, but that could be the logical long-term aim for the Danish drugmaker.

The ideal scenario is that pricing and timelines remain the same for customers, said Nicole Paulk, CEO of the gene therapy startup Siren Biotechnology.

Nicole Paulk

“The name of the group that you’re going to send your check to is now going to be Novo Holdings instead of Catalent, but otherwise everything remains the same,” Paulk told Endpoints. “That’s the best-case scenario.”

In a worst case, Paulk said she feared the new owners could wind up closing sites or laying off Catalent groups. That could create some uncertainty for customers looking for a long-term manufacturing partner.

Are shareholders and regulators happy? 

The pandemic was a wild ride for Catalent’s stock, with shares surging from about $40 to $140 and then crashing back to earth. The $63.50 share price for the takeover is a happy ending depending on the investor.

On that point, the investing giant Elliott Investment Management is satisfied. Marc Steinberg, a partner at Elliott, called the agreement “an outstanding outcome” that “clearly maximizes value for Catalent stockholders” in a statement.

Elliott helped kick off a strategic review last August that culminated in the sale agreement. Compared to Catalent’s stock price before that review started, the deal pays a nearly 40% premium.

Alessandro Maselli

But this is hardly a victory lap for CEO Alessandro Maselli, who took over in July 2022 when Catalent’s stock price was north of $100. Novo’s takeover is a tacit acknowledgment that Maselli could never fully right the ship, as operational problems plagued the company throughout 2023 while it was limited by its debt.

Additional regulatory filings in the next few weeks could give insight into just how competitive the sale process was. William Blair analysts said they don’t expect a competing bidder “given the organic investments already being pursued at other leading CDMOs and the breadth and scale of Catalent’s operations.”

The Blair analysts also noted the companies likely “expect to spend some time educating relevant government agencies” about the deal, given the lengthy closing timeline. Given Novo Nordisk’s ascent — it’s now one of Europe’s most valuable companies — paired with the limited number of large contract manufacturers, antitrust regulators could be interested in taking a close look.

Are Catalent’s problems finally a thing of the past?

Catalent ran into a mix of financial and operational problems over the past year that played no small part in attracting the interest of an activist like Elliott.

Now with a deal in place, how quickly can Novo rectify those problems? Some of the challenges were driven by the demands of being a publicly traded company, like failing to meet investors’ revenue expectations or even filing earnings reports on time.

But Catalent also struggled with its business at times, with a range of manufacturing delays, inspection reports and occasionally writing down acquisitions that didn’t pan out. Novo’s deep pockets will go a long way to a turnaround, but only the future will tell if all these issues are fixed.

Kutay said his team is excited by the opportunity and was satisfied with the due diligence it did on the company.

“We believe we’re buying a strong company with a good management team and good prospects,” Kutay said. “If that wasn’t the case, I don’t think we’d be here.”

Amber Tong and Reynald Castañeda contributed reporting.

Read More

Continue Reading

International

Petrina Kamya, Ph.D., Head of AI Platforms at Insilico Medicine, presents at BIO CEO & Investor Conference

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb….

Published

on

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

Credit: Insilico Medicine

Petrina Kamya, PhD, Head of AI Platforms and President of Insilico Medicine Canada, will present at the BIO CEO & Investor Conference happening Feb. 26-27 at the New York Marriott Marquis in New York City. Dr. Kamya will speak as part of the panel “AI within Biopharma: Separating Value from Hype,” on Feb. 27, 1pm ET along with Michael Nally, CEO of Generate: Biomedicines and Liz Schwarzbach, PhD, CBO of BigHat Biosciences.

The session will look at how the latest artificial intelligence (AI) tools – including generative AI and large language models – are currently being used to advance the discovery and design of new drugs, and which technologies are still in development. 

The BIO CEO & Investor Conference brings together over 1,000 attendees and more than 700 companies across industry and institutional investment to discuss the future investment landscape of biotechnology. Sessions focus on topics such as therapeutic advancements, market outlook, and policy priorities.

Insilico Medicine is a leading, clinical stage AI-driven drug discovery company that has raised over $400m in investments since it was founded in 2014. Dr. Kamya leads the development of the Company’s end-to-end generative AI platform, Pharma.AI from Insilico’s AI R&D Center in Montreal. Using modern machine learning techniques in the context of chemistry and biology, the platform has driven the discovery and design of 30+ new therapies, with five in clinical stages – for cancer, fibrosis, inflammatory bowel disease (IBD), and COVID-19. The Company’s lead drug, for the chronic, rare lung condition idiopathic pulmonary fibrosis, is the first AI-designed drug for an AI-discovered target to reach Phase II clinical trials with patients. Nine of the top 20 pharmaceutical companies have used Insilico’s AI platform to advance their programs, and the Company has a number of major strategic licensing deals around its AI-designed therapeutic assets, including with Sanofi, Exelixis and Menarini. 

 

About Insilico Medicine

Insilico Medicine, a global clinical stage biotechnology company powered by generative AI, is connecting biology, chemistry, and clinical trials analysis using next-generation AI systems. The company has developed AI platforms that utilize deep generative models, reinforcement learning, transformers, and other modern machine learning techniques for novel target discovery and the generation of novel molecular structures with desired properties. Insilico Medicine is developing breakthrough solutions to discover and develop innovative drugs for cancer, fibrosis, immunity, central nervous system diseases, infectious diseases, autoimmune diseases, and aging-related diseases. www.insilico.com 


Read More

Continue Reading

Trending