Monday, February 07, 2022

‘You will not believe what I’ve just found.’ Inside the Ivermectin saga: a hacked password, mysterious websites and faulty data.

How a drug used to treat parasites for decades became the hot and controversial drug of the pandemic

Feb. 7, 2022 
By Jaimy Lee
MARKETWATCH PHOTO ILLUSTRATION/ISTOCKPHOTO

LONG READ

Last May, a graduate student named Jack Lawrence sat down in his apartment and began combing through a medical study about ivermectin for his coursework at the University of London.

The study, conducted by researchers at Benha University in Egypt and published in November 2020, had produced stunning results. It found that ivermectin, an antiparasitic drug that’s been around for decades, could reduce the risk of death among COVID-19 patients by 90%, among other findings.

“Suddenly, I started noticing something,” Lawrence said. “Although there [were] a lot of parts of the paper that were badly written, there are also a few sentences which had perfect grammar, perfect everything, and could have been plucked right out of another scientific paper. And, in fact, they were. I put them into Google. Each of these sentences got a hit.”

Lawrence, who is in his mid-20s and studying biomedical science, kept researching online. He clicked through to a file-sharing website, where the study’s dataset was housed. Lawrence paid $10.80 for a subscription to reactivate the link, which had expired in January 2021, only to find the file required a password. He made a few attempts, and then he tried “1-2-3-4.” It worked.

From there, Lawrence discovered that the issues went far beyond plagiarism. The number of deaths cited in the paper did not match the number of deaths in the database. Some of the patient data had been duplicated. Other patients included in the trial had been hospitalized before the study began.

“I was working in my room,” he said. “And I went out of my room to tell everyone, you know, my housemates, being like, ‘Oh, my God, you will not believe what I’ve just found.’ ”

Lawrence would go on to contact Research Square, the website that published the paper, which had not been peer-reviewed. Within 24 hours, Lawrence got a response from the editor, and the website withdrew the paper in mid-July.

It’s just one of several retractions and withdrawals of studies pointing to ivermectin as a viable COVID-19 treatment, and the impact of this kind of fraudulent research is still reverberating. During the pandemic, there has been a surge of demand for ivermectin, a drug commonly used to treat parasites in people who live in regions of South America and Africa, as well as in livestock.

The number of monthly ivermectin prescriptions in the U.S. jumped to a high of 454,000 in August 2021, from about 57,000 in January 2020, according to healthcare data firm IQVIA. This figure doesn’t take into account veterinary prescriptions, which also increased when people began to seek out novel means of gaining access to the drug. Research published in January estimates that health insurers spent about $2.5 million on ivermectin prescriptions for COVID-19 in one week of August 2021.

The Benha research was cited in a doctor’s congressional testimony before it was debunked, and the drug has been touted by celebrities and politicians, as well as a mysterious and popular website with no known authors. Ivermectin proponents describe the drug as cheap, safe and readily available, and say it can work as both a COVID-19 treatment and prophylaxis.

Yet no comprehensive clinical trials have found that ivermectin works as a COVID-19 treatment. To make this issue even more complicated, no “gold standard” studies have yet found explicitly that it’s useless against COVID-19 or that it’s harmful to people taking it.

The ivermectin saga shows how the American drug regulatory system has been overrun by the pressures of the pandemic, including the rush to put out new research and then act immediately on those findings. This led a graduate student hacking into a database to find the truth, and the Food and Drug Administration cracking online jokes to warn people that ivermectin was not a suitable COVID-19 treatment. “You are not a horse,” the U.S. regulator tweeted in August, in an attempt to stop Americans from using ivermectin, warning the drug could be toxic if taken at the highly concentrated doses given to large animals.

Gideon Meyerowitz-Katz, an Australian epidemiologist who has become an expert on ivermectin during the pandemic, says it’s not unreasonable for the average person to think ivermectin is a solid COVID-19 treatment. After all, the public is watching trusted people recommend or take the drug. But he thinks they are being misled.

“A lot of the debate and discussion is driven by people who, for whatever reason, think ivermectin is a miracle cure, even despite the evidence that it probably isn’t,” Meyerowitz-Katz said. “It’s become incredibly politicized at this point.”

There will be new data coming soon from a pair of randomized clinical trials that may reveal just how effective ivermectin is as a COVID-19 treatment. Dr. David Boulware, an infectious-disease physician and scientist in charge of one of those ivermectin studies, says the whole point of testing drugs in people is to generate such definitive data.

“There’s tons of people prescribing [ivermectin], but there’s actually very little data,” Boulware says.


Ivermectin boosters: Sen. Ron Johnson, a Wisconsin Republican, and Dr. Pierre Kory.
DREW ANGERER/GETTY IMAGES

A series of low-quality studies and a ‘miracle drug’


To really understand ivermectin’s roots as a COVID-19 treatment in the U.S., you have to look to Wisconsin, home to Senate Republican Ron Johnson, Green Bay Packers quarterback Aaron Rodgers and Dr. Pierre Kory. Each is a prominent American figure in the ivermectin story.

While Kory is not famous, he and an organization he helped found have played a big role in popularizing ivermectin as a COVID-19 treatment. A critical-care physician, Kory practiced medicine at University of Wisconsin Health in Madison until he resigned over his frustration with the hospital’s COVID-19 care practices. Now he’s one of the founders of the Front Line COVID-19 Critical Care Alliance, an organization known as FLCCC that promotes an outpatient, inpatient and long-COVID treatment plan.

Kory remembers when the first preprint assessing ivermectin’s viability as a COVID-19 treatment was published in April 2020. Preprints, which are studies that haven’t been reviewed by other experts, have long been used in economics and math, but they became widely used in the pandemic to speed up the dissemination of new medical and scientific findings. The ivermectin preprint that got Kory’s attention had been published by researchers in Australia. It described an in-vitro study, meaning it was conducted in a laboratory and not in people or animals. In very large doses, ivermectin demonstrated antiviral action against the virus.

“A lot of the debate and discussion is driven by people who, for whatever reason, think ivermectin is a miracle cure, even despite the evidence that it probably isn’t.” 
— Gideon Meyerowitz-Katz, University of Wollongong

Some researchers had immediately disregarded the study, despite its being well-designed, based on the dosing.

“I saw that when it came out, and I did the mathematical calculation of, is this a drug level you can achieve?” Boulware told me. “I quickly realized, no, this is 50 to 100 times higher than you’d ever get in a human. It took me about 15 minutes to figure out that this was not going to be useful as an antiviral. I set it aside and moved onwards.”

There was little interest in ivermectin in the U.S. in those days, though the FDA began warning people that same month not to self-medicate with ivermectin formulations intended for animals. Ivermectin is considered a very good and safe treatment for parasitic worms that can cause diseases in people like river blindness, and is also used to treat worms in livestock and pets.

In the spring and summer of 2020, much of the nation’s focus was on three other therapies: hydroxychloroquine, a drug that received emergency-use authorization as a COVID-19 treatment in March 2020; convalescent plasma, which received an EUA of its own in August 2020; and Gilead Sciences’ GILD, -0.22% remdesivir, an antiviral that was eventually approved by the FDA and is now considered part of the standard of COVID-19 care for very sick patients.

“What then happened was a series of very low-quality studies published towards the end of [2020], and they reported huge benefits for ivermectin,” Meyerowitz-Katz said.

It was around October of that year that Kory, back in Wisconsin, says he saw promising preliminary data out of research conducted in Bangladesh, the Dominican Republic and Peru. He began prescribing ivermectin to COVID-19 patients.

At that time, Roche Holding’s ROG, -0.13% “tocilizumab was not looking good. Hydroxychloroquine from the randomized control trials was not looking good. Convalescent plasma. … These are all things that were being used therapeutically,” Kory said. “And when we saw ivermectin — this is mid-October 2020 —w e were just astounded by the consistency and reproducibility from a number of different trials from countries around the world.”

Within a month, the FLCCC published its first outpatient COVID-19 protocol, which included ivermectin. Then Johnson extended a second invitation to Kory to testify before Congress.

At a Senate hearing on Dec. 8, 2020, three days before the first COVID-19 vaccine was authorized in the U.S., Kory’s testimony described ivermectin as a “miracle drug” that could be used more quickly than the vaccines, which would take months to roll out. His testimony several times referenced the Benha University preprint promising major clinical benefits, and video of the testimony went viral on YouTube.

“Nearly all studies are demonstrating the therapeutic potency and safety of ivermectin in preventing transmission and progression of illness in nearly all who take the drug,” Kory wrote in his prepared testimony.

The video of the testimony was removed from YouTube, but ivermectin’s ascension into the mainstream had begun. The number of ivermectin prescriptions in the U.S. doubled in a single month — to nearly 154,000 scripts in December 2020, from 72,000 in November 2020, according to the IQVIA data.

From that point on, it became clear that there was a fan base dedicated to ivermectin and its purported COVID-19 benefits. Politicians like Johnson and Rep. Marjorie Taylor Greene, a first-term Republican from Georgia, touted it. Rodgers, the famous quarterback, and conservative talk-show host Glenn Beck both said in interviews that they had taken it after testing positive for the virus. So did Joe Rogan, who also talked about the benefits on his popular Spotify SPOT, -1.67% podcast, where he described getting a recommendation for ivermectin from Kory.


Pandemic prescription: Ivermectin has become a popular COVID-19 treatment amid an absence of good data. AP PHOTO/MIKE STEWART

‘Studies that probably never happened’


The ivermectin story changed as Jack Lawrence, the University of London graduate student, started contacting other researchers to verify his initial findings in the flawed Benha preprint.

In June 2021, he reached out to Nick Brown, a psychologist and researcher at Linnaeus University in Sweden known for hunting fraud in research, who connected him to Meyerowitz-Katz, the Australian epidemiologist. Lawrence essentially asked them to double-check his work before messaging Research Square about what he’d found. He was just a graduate student and wanted to make sure he hadn’t missed something.

“I’d read about [Brown] before,” Lawrence said, “so I sent him that, and he immediately found a whole range of different duplicate values, far more than I could ever have found.”

Michele Avissar-Whiting, Research Square’s editor in chief, said in a statement that, “based on what Jack found, we have reason to believe the preprint’s conclusions are compromised, so the withdrawal was done to stop its propagation as sound science.”

It was one of the most high-profile retractions of ivermectin research to date, but it was not the first. The problems have also extended to peer-reviewed work. In mid-2020, an ivermectin study published in the prestigious New England Journal of Medicine was retracted. It included data from Surgisphere, a company that also provided inaccurate patient data to a study about hydroxychloroquine, which was retracted, as well. Experts say the peer-reviewed study was especially problematic because its findings had been used to inform Peru’s decision to allow ivermectin as a COVID-19 drug in the early months of the pandemic. (That approval was revoked in 2021, according to the Guardian.)

Then came the Benha retraction. Next up was a meta-analysis of trials that treated COVID-19 patients with ivermectin, published last summer in Open Forum Infectious Diseases. It had to be corrected in August 2021 as having cited a fraudulent study. (Andrew Hill, one of the paper’s authors and a researcher at the University of Liverpool, wrote last fall in the Guardian that he received death threats after he revised his research.)

The Journal of Antibiotics in September retracted a study published in June, saying the editor was no longer confident in the research’s findings. This was followed by the October retraction of a study conducted by researchers in Lebanon and published in the journal Viruses that said ivermectin reduced symptoms and lowered viral load. In November, the Journal of Intensive Care Medicine retracted research published by FLCCC physicians over concerns about the accuracy of some of the data.

“We can say with some confidence at this point that the very large benefits that people were proposing for ivermectin were based on studies that probably never happened,” Meyerowitz-Katz said. “There may still be benefits for ivermectin, but they’re probably going to be quite a bit smaller than many people had hoped earlier [in 2021], when they were relying on this potentially fabricated research.”

What is unclear is whether the retractions and withdrawals of some of the key scientific data underpinning the case for ivermectin will change anything for the people who believe in the drug’s potential.

“What people are doing [is] essentially weaponizing the scientific self-correction process, which, by the way, is a very flawed process,” said Ivan Oransky, a longtime healthcare journalist and co-founder of Retraction Watch, a site that tracks retractions in scientific research. “What they’re doing is sort of weaponizing any corrections or any retractions or any sort of doubt — the kind of skepticism you want — and turning it into why they’re right.”

Kory now says the Benha study is deeply flawed — “that paper stinks,” he told me — but he puts the blame for the wave of retractions and withdrawals of ivermectin studies on pharmaceutical companies that he said have spent decades developing disinformation campaigns that aim to restrict the repurposing of cheap generic drugs.

“It would dry up the sales of remdesivir and Paxlovid and molnupiravir,” said Kory, referring to some of the most prominent therapeutics, developed by Gilead, Pfizer PFE, +0.40% and Merck & Co. MRK, -1.25%, which have been authorized to treat COVID-19. “You name it. Monoclonal antibodies. It literally threatened the market value of almost anything out there on a global pandemic.” Kory added: “What we’re talking about, a historic corruption, the disinformation campaign waged against a repurposed drug.”

Still, even simple scientific information has been falsely used to promote the effectiveness of ivermectin. For example, some ivermectin proponents, including House Republican Greene, cite the fact that the scientists who discovered ivermectin won a Nobel Prize in 2015, without making clear the prestigious award was given in recognition of the drug’s effectiveness against parasitic disease, and had nothing to do with COVID-19.

“People who are drawn to these sorts of ideas like doing their own research and like happening upon these very convenient Easter egg–type facts,” said Philip Corlett, an associate professor of psychiatry at Yale School of Medicine who has researched paranoia in the pandemic. “They’re like, ‘I found it. The mainstream medical establishment and the media ignored it.’ … It becomes something that you’ve cultivated. You’ve uncovered it. You’ve helped propagate. You feel a real sense of belonging over it, too.”

For those who have been involved in ensuring the scientific data about ivermectin is up to snuff, the combination of the pandemic and armchair epidemiology has at times been unsettling. Retraction Watch’s Oransky says he’s worried about the tone of some tweets that have mentioned an old home address, which is where he had originally registered the organization that houses Retraction Watch. “You get scared a little bit,” Oransky said.

TERRENCE HORAN/MARKETWATCH

A mysterious website


There’s one website often cited by ivermectin’s supporters: c19early.com. It’s got a clean, white layout and says it has pulled together “real-time analysis of 1,387 studies” for a wide-ranging list of potential COVID-19 therapies that can be used for early treatment, as of Feb. 7. It includes URLs like Ivmmeta.com and Hcqmeta.com.

No one I spoke with, including Kory, knows who runs the website. The website’s Twitter account has been suspended, and emails asking for information about who owns or operates the site were not returned. Some of the treatment protocols listed are provided by the FLCCC.

“It would be fascinating to know who’s behind such a massive effort,” Meyerowitz-Katz said. “It’s pseudoscientific nonsense, but it is also absolutely a huge effort.”

When I first dropped a sentence written several times on the site — “Elimination of COVID-19 is a race against viral evolution” — into Google, several websites with URLs that have nothing to do with COVID-19 or healthcare pop up with that description. Many of the top search results lead to online pages that have been moved or deleted, but one link redirects to a website selling Stromectol, the brand name for the form of ivermectin marketed by drug giant Merck to treat parasitic worms. That site, which says it is owned by Canadian Pharmacy Ltd., lists phone numbers in London and New York City. Both go directly to a generic voicemail.

Boulware, who is based in Minneapolis, said he messaged a website promoting ivermectin about a year ago, to see if it would accept his help with the medical information being put out. The site has some great charts, he said, but, in some cases, the data were not valid. When the responses to his emails were returned in the middle of the night, it made him wonder if the site’s operators were based in a foreign country. He speculated that maybe the website could be Russian disinformation or coming from a generic-drug maker in India trying to skirt FDA regulations.

“Those websites are a lot of effort. They’re really detailed,” Boulware said. “So it’s got to be either someone who has a lot of free time on their hands, or someone’s got a financial motivation or a political-disinformation motivation.”

It’s become virtually impossible for anyone without a scientific background or a working knowledge of misinformation and disinformation to make sense of the sheer volume of information about the virus, treatments and vaccines that is generated every day — real or not.

About half of the 6,785 studies published in 2021 on the preprint server MedRxiv had to do with the pandemic.

“Every fact in COVID-19 context is being contested,” said Kasisomayajula Viswanath, a professor of health communication at the Harvard T.H. Chan School of Public Health. “Facts are changing constantly because the science is changing. And that has provided room for people to interpret it from their own perspective. I think that’s one reason. The second is because it has become extremely politicized.”

The people who believe ivermectin is a safe and effective COVID-19 treatment tend to be white men who are not vaccinated and identify as Republican voters, according to Liz Hamel, the director of public opinion and survey research at the Kaiser Family Foundation, which is conducting ongoing research on attitudes about COVID-19 during the pandemic.

“It seems to peak among 50- to 64-year-olds,” she said. “We do see that people over 65, regardless of partisanship, have been taking this disease more seriously. And young people tend to have more liberal political attitudes. So we often see that it’s people in the middle-age categories who stand out.”

But Kory said support for ivermectin as a COVID-19 treatment is not driven by political affiliation. “We’re not some right-wing conservative group,” Kory said. “In fact, the opposite. However, I don’t know whether it was the era of Trump that did it because he spoke well of hydroxychloroquine, but my take on the politicization of the science is that because our recommendations run contrary to the prevailing ones from the agencies, that means we’re a contrarian group.”

Even people who work in healthcare and medicine have had to learn how to interpret scientific research differently. In the past, companies or researchers conducted studies and then submitted the research to a medical journal, where it was peer-reviewed and then eventually published. Before the pandemic, the scientific process was much slower, usually taking months or even years to lock down a standard of care or scientific consensus. Now companies sometimes share snippets of data in news releases, and much of the pandemic research has been published first as a preprint and is only peer-reviewed later.

For people who are inexperienced with medical research, fragments of data and half-baked preprints can be even harder to decipher. They can be strung together and shared online with a link, and then picked up by politicians or media outlets. At the same time, algorithms are tracking what users are watching and reading and then serving up similar content to them.

“That’s what I call a spiral of amplification,” Viswanath said. “It starts small in some obscure corner — one study, one preprint — and or one person [or] group saying something, and a few groups talking about it on social media. Somehow it is picked up by certain political actors. And then it starts going mainstream. And that’s what has been happening with hydroxychloroquine, and that’s what has been happening with ivermectin.”


Last week Joe Rogan sent and deleted a tweet citing an incorrect report that a Japanese trial showed ivermectin to be clinically effective against COVID-19. 
CARMEN MANDATO/GETTY IMAGES

Good data on ivermectin coming soon

Sometime this winter or early spring, a randomized, placebo-controlled, double-blind trial sponsored by the National Institutes of Health that is testing ivermectin in 1,000 patients is expected to produce results, says Dr. Susanna Naggie, the vice dean for clinical research at Duke University’s medical school and the researcher running the trial.

The University of Minnesota’s randomized study has enrolled 1,196 participants, one-third of whom received ivermectin. (Both trials are evaluating several repurposed drugs as possible COVID-19 treatments.) Within the next few weeks, the Minnesota institution is expected to share the first findings from the ivermectin part of its trial, nearly two years after the first preprint examining ivermectin’s viability was published.

In pandemic time, this may feel overly slow, but, for the scientists conducting these trials, it’s still a pretty quick turnaround. The experts I spoke to seem to think that ivermectin could demonstrate a small benefit for some COVID-19 patients, but none think it’s likely that it will produce any of the major benefits promised by the fraudulent trials.

Edward Mills, a health-sciences professor at Canada’s McMaster University, is co-investigator of the Together clinical trial, another rigorous study that is evaluating nine different repurposed drugs as COVID-19 therapies, including ivermectin. It recently completed the ivermectin analysis but found it “did not demonstrate an important benefit,” Mills said in an email. The research may be published this month, he said.

Nevertheless, there is an idea circulating among scientists like Mills that ivermectin may be more likely to benefit COVID-19 patients in areas of the world with a high prevalence of parasitic worms. “What is possible is that co-infection of parasites with COVID may worsen health outcomes,” Mills said.

This is an idea also raised by Boulware, the scientist working on the University of Minnesota’s ivermectin study. Corticosteroids, like dexamethasone, are now considered the standard of care for severely ill COVID-19 patients; however, these drugs can cause what is called a “hyperinfection” and sometimes be fatal in a patient who has a parasitic infection. It’s possible that additional data about ivermectin gathered from different patient populations could show the drug being more beneficial in people who live in parasitic regions of the world, they say.

However, most native-born Americans don’t have parasites. And, since 2005, the U.S. policy has been to recommend that refugees from Africa, Asia, the Middle East, Latin America and the Caribbean receive treatment or presumptive antiparasitic treatment — including ivermectin — before arriving in the U.S.

“In certain patient populations, if you have a parasitic infection, it certainly can be beneficial if you’re giving steroids,” Boulware said. “Does that mean [as an] outpatient-setting early therapy in the U.S. that there’s a benefit? We don’t know that, and so I think that is an unknown question.”

For now, the healthcare professionals who have been put in the position of saying “no” to prescribing ivermectin are waiting for the data from the U.S. trials. Dr. Rani Sebti, an infectious-disease physician at Hackensack Meridian Health hospital system in New Jersey, says he’s been fielding calls from primary-care doctors in the U.S. and abroad about whether to prescribe ivermectin when patients ask for it.

“I cannot sit here and tell you ivermectin is the worst drug in the world,” he said. “I need to see a good prospective, double-blind, placebo-controlled study. And then when we get that study, it will answer the question for good.”
DIRECT ACTION GETS THE GOODS
MMG may halt Peru Las Bambas mine operations by Feb 20 after latest blockade


FILE PHOTO: Peru's Andean rural residents complain of negative effects of mining activity

Sun, February 6, 2022, 6:52 PM·1 min read

(Reuters) - MMG Ltd said on Monday that production at its Las Bambas copper mine in Peru may stop by Feb. 20 after a local community blocked again a road used by the miner, causing the company to curtail operations.

The Chinese-owned mine has been a flashpoint of protests and road blockades since it started functioning in 2016, with operations last suspended in December due to a similar blockade.

Despite an agreement being reached in December to restart operations, leaders of a group of Peruvian communities later rejected a government proposal to prevent future blockades.

The Chumbivilcas communities - mostly indigenous citizens of Quechua descent - have repeatedly accused the Chinese company of failing to provide jobs and money to the region, one of the poorest in Peru, despite the vast mineral wealth.

In the latest development, MMG said the local community had erected a new blockade of around 100 kilometres from the copper mine.

"Due to the restrictions to both inbound and outbound transportation, Las Bambas has been forced to progressively reduce mine operations," the company said in a statement, adding that it was working with the government and community to deliver the December agreement.

The miner said production will be halted circa Feb. 20 if the roadblock does not end.

(Reporting by Nikhil Kurian Nainan in Bengaluru; Editing by Sherry Jacob-Phillips)
Americans exposed to toxic BPA at levels far above what EU considers safe – study

Tom Perkins
Sun, February 6, 2022,

Photograph: Jonathan Brady/PA

A comprehensive review of recent studies into a chemical often used in plastics and resins has revealed that the average American is exposed to levels of the dangerous compound that are 5,000 times higher than what the European Union now considers safe.

The main exposure route for bisphenol-A (BPA) is via plastic and metal food packaging, and that has prompted a call for strong new limits on its use.

In a petition sent last week to the US Food and Drug Administration, consumer advocates and food safety scientists led by the Environmental Defense Fund warned that the European Food Safety Authority’s (EFSA) December review clearly shows that BPA exposure levels in the US represent a “high health risk” for Americans of all ages.

“The FDA has an obligation to protect us from toxic chemicals that can come in contact with our food,” said Maricel Maffini, a petition co-author. “These new findings should be a wakeup call to the FDA and all of us that our health is in jeopardy unless we take swift action to limit the amount of BPA that can come into contact with our food.”

The chemical mimics estrogen and is linked to a range of serious health problems, including cancer, immunotoxicity, neurological toxicity, mammary gland disease, behavioral changes and decreased sperm counts, among others.

Male and female brains in mammals are physically different, and Maffini noted a study that found BPA exposure altered male brains to look more like female brains. EFSA’s research pointed to evidence suggesting harm from BPA exposure can occur at levels 100,000 times lower than previously thought, and scientists have found immune system disruptions occur at particularly low levels.

“What we are seeing now is that the levels that we thought were safe – they don’t seem to be safe, and the levels that we identify as causing problems in the immune system are incredibly low,” Maffini said.

Related: Bisphenol: what to know about the chemicals in water bottles and cans

In food packaging, BPA is typically used to line metal cans to prevent corrosion, though plenty of safer alternatives exist, Maffini said. It’s also mixed into polycarbonate plastic, which is a clear, shatterproof material used in multi-use water bottles, containers that hold pre-prepared foods or containers used to hold ingredients during food prep, among other uses. The petition asks that those applications be prohibited.

The FDA has 180 days to respond to the petition, though it can take longer on complex issues, Maffini said. Consumer groups’ petitions have led to some success in recent years. The FDA agreed with a 2016 petition led by the Environmental Defense Fund to ban the use of long-chain PFAS in food packaging, though it has yet to respond to a 2021 petition to ban all PFAS. A 2015 EDF-led petition to prohibit seven carcinogenic food flavorings resulted in the FDA banning the substances in 2018.

However, the FDA’s science and position on BPA has often been at odds with that of academic scientists, consumer advocates, the US National Toxicology Program, and the FDA’s own advisory committees, Maffini said.

While those groups have consistently found BPA to present a dangerous health threat, the FDA has downplayed the dangers and often relied on inadequate scientific methods to arrive at its conclusions, Maffini said.

However, the FDA banned BPA from baby bottles, sippy cups and infant formula packaging in 2012. The agency said in a statement that it doesn’t comment on pending petitions.
Texas professor dismissed after recommending students mask


Michael Mooney
Mon, February 7, 2022

A professor at Collin College says his contract won’t be renewed because he spoke publicly about the school’s COVID-19 protocols.

Michael Phillips, who teaches history and wrote the book “White Metropolis: Race, Ethnicity, and Religion in Dallas, 1841-2001,” also received warnings from college administrators after writing an op-ed calling for the removal of Confederate monuments.

Why it matters: North Texas has become a flashpoint in the national battle over free speech in public education, with an increase in calls to ban books and strife over restrictions on how teachers can discuss racism.

What happened: Last August, Phillips tweeted a photo of a presentation from the administration that said faculty and staff could not request, require or recommend students wear a mask.

While lecturing about the 1918 influenza epidemic, Phillips says, he instructed students to “think about the consequences of what you’re doing and the risks you might pose to your community.”

Phillips tells Axios that school administrators suggested he say he was leaving voluntarily to “construct a narrative” that avoided negative attention.

What they’re saying: “You can’t have an environment of learning in a situation like that. It has such a pernicious effect both in and out of the classroom,” Phillips says.

“It’s become the panopticon. Faculty members are even afraid to speak to each other.”

The other side: Collin College has said it won’t comment on personnel matters.


“Given that the renewal or non-renewal of faculty contracts is a routine operational matter at the college, we are dismayed at the efforts of some individuals to present this as anything other than what it truly is,” a spokesperson said in a statement.

Zoom out: Last week, the Academic Freedom Alliance called on the school to reverse its decision to dismiss Phillips.

"Professor Phillips is being retaliated against for his constitutionally protected criticism of the college’s administration," Keith Whittington, chair of the AFA’s academic committee, wrote in an open letter to Collin College District President H. Neil Matkin.

Context: Phillips is the fourth Collin College professor to not have a contract renewed amid concerns over free speech and academic freedom.

Phillips was notified about his dismissal just two days after another professor, Lora Burnett, settled a lawsuit with the college for $70,000. Burnett was dismissed after she tweeted that then-Vice President Mike Pence had a “little demon mouth,” according to the Dallas Observer.

A lawsuit from another professor, Suzanne Jones, is ongoing.

Last year the The Chronicle of Higher Education ran a particularly unflattering profile of Matkin.

Of note: Collin College doesn’t have faculty tenure. Full-time professors sign multi-year contracts with the school.

What’s next: Phillips has legal representation.

Like this article? Get more from Axios and subscribe to Axios Markets for free.
UK
Politicians who criticised AstraZeneca vaccine 'probably killed hundreds of thousands', says Oxford scientist


Poppie Platt
Mon, February 7, 2022,

Oxford's Professor Sir John Bell said leaders who criticised the jab "cannot be proud" of their impact - Aaron Chown/PA

Scientists and politicians who expressed critical views of the AstraZeneca Covid vaccine “probably killed hundreds of thousands of people”, an Oxford professor has said.

Professor Sir John Bell said critical comments from leaders, including French president Emmanuel Macron, had “damaged the reputation of the jab” around the world, resulting in less people accessing the life-saving vaccine.

Speaking to the BBC Two programme AstraZeneca: A Vaccine for the World?, which will be broadcast on Tuesday at 9pm, Prof Bell said: “I think bad behaviour from scientists and politicians has probably killed hundreds of thousands of people – and that they cannot be proud of.”

Macron had previously claimed that the vaccine “doesn’t work as expected” and appeared to be “quasi-ineffective” in the over-65s.

Speaking just hours before the European Medicines Agency (EMA) approved the AstraZeneca jab for use in the bloc, Macron also criticised the UK’s decision to administer vaccine doses 12 weeks apart, falsely claiming it could “accelerate the mutations” of the virus.


French president Emmanuel Macron gestures as he speaks to staff working in the intensive care ward of the Poissy/Saint-Germain-en-Laye hospital, near Paris, with French Health Minister Olivier Veran, right, and Chief of Intensive Care Unit Dr. Jan Hayon in March 2021 - Yoan Valat/EPA POOL

Other EU countries, including Germany, Spain and Italy, also temporarily suspended use of the AstraZeneca jab last year when it was linked to a tiny risk of blood clots.

The US has still not approved the vaccine, with Dr Antony Fauci of the National Institute of Allergy and Infectious Disease previously saying that the country "may not need to use" the jab despite it being a "good vaccine", because of the widespread use of the Pfizer and Moderna jabs.

Despite its reputation being marred by criticism, the AstraZeneca jab has been heralded for its rollout in less wealthy countries as part of the Covax programme.

Scientists have suggested that the UK’s widespread use of the AstraZeneca vaccine – and its early rollout to elderly and vulnerable people – could be responsible for the relatively low death toll from the omicron variant compared to countries in Europe.

Dr Clive Dix, former chairman of the Vaccine Task Force, told The Telegraph that he believed the AstraZeneca jabs offered more robust, long-term protection against severe disease and death than RNA-based alternatives made by Pfizer and Moderna.
Easing curbs in 'COVID-zero regions' could cause 2 million deaths in a year - China study



Sun, February 6, 2022
By David Stanway

SHANGHAI (Reuters) -Restoring normal population mobility to "COVID-zero regions" like China will cause some 2 million deaths in a year and the key to controlling the virus is developing vaccines that are better at preventing infection, Chinese researchers said.

China's "zero-COVID" restrictions have come under growing scrutiny in recent weeks as it hosts the Winter Olympics in Beijing while using sweeping restrictions to try to prevent the spread of the more infectious Omicron variant.

Chinese scientists and public health specialists have reiterated the need for maintaining the stringent controls, saying the risks of transmission were too high and that mass infection would put intolerable pressure on the health system.

The researchers used studies from Chile and Britain to calculate the "baseline efficacy" of current vaccines - CoronaVac in the case of Chile and the Pfizer and Oxford/AstraZeneca shots in Britain.

They estimated the baseline efficacy against symptomatic disease of the vaccines was 68.3%. They estimated the baseline efficacy of existing vaccines against death was 86%.

The efficacy estimate against infection - found to be 30% -is based on British data and efficacy against symptomatic disease and deaths was based on data extracted from a study on Sinovac's CoronaVac in Chile.

But even with a global vaccination rate of 95%, if population mobility was restored to 2019 levels, the researchers estimated that all COVID-zero regions would see more than 234 million infections within a year, including 64 million symptomatic cases and 2 million deaths.

"The human race should continue to develop vaccines and explore new ways to improve vaccine protection against infection in order to eliminate COVID-19 at the global level," the team of Chinese scientists said in a paper, published on Friday in the weekly bulletin of the China Center for Disease Control and Prevention (CCDC).

To reduce the incidence of COVID-19 to the levels of influenza after restoring normal mobility, the efficacy of vaccines against infection needs to be increased to 40% and the efficacy against symptomatic disease needs to be increased to 90%, they said.

They said it was more important for new vaccines to be effective against infection than against symptomatic disease or death.

"The key to controlling COVID-19 lies in the development and widespread use of vaccines that are more effective at preventing infection," the team said.

China is the only major economy sticking with a zero-COVID policy despite warnings it could hurt growth. Others, like Singapore, Australia and New Zealand, have abandoned the strategy in favour of what policymakers call "learning to live with COVID".

"Throughout the world, except in China and Western Australia, everyone else has moved on," said Jaya Dantas, professor of international health at the Curtin School of Population Health in Perth, Australia, who described the Chinese paper as "very pessimistic".

"This is basically an in-house document: it is very focused on the China scenario, and they might want to support what the government is supporting, which is a zero-COVID policy."

China has been doubling down on its zero-COVID message and continues to seal off entire cities. The Beijing Winter Olympics are being held in a "closed-loop" bubble that some athletes have branded as excessive.

"We previously thought COVID-19 could be basically contained through vaccines but now it seems that there's no simple method to control it except with comprehensive measures," the CCDC's chief epidemiologist Wu Zunyou told the Communist Party-run Global Times on Sunday.

(Reporting by David StanwayEditing by Robert Birsel, William Maclean)
TOYS FOR BOYS OF THE 1%
It's not just Jeff Bezos. Super rich around the world are snapping up superyachts as sales hit a record high last year.

Huileng Tan
Mon, February 7, 2022

Jeff Bezos' superyacht "Flying Fox" anchored offshore of Yali neighborhood of Mugla, Turkey in November. Bezos' new yacht, known only as Y721, is currently being built in Alblasserdam, Netherlands.
Ali Balli/Anadolu Agency via Getty Images

A record 887 superyachts were sold last year, up 77% from 2020, according to VesselsValue.


An "increased need for privacy and private isolation" is driving demand.


Supply was unable to keep pace with demand due to supply chain constraints and movement restrictions.

Super rich people who craved more privacy during the pandemic have taken to the high seas, sending the sales of superyachts to a record high last year.

One reason for the spike in multimillion superyacht sales is "the increased need for privacy and private isolation" that such vessels can provide, said Sam Tucker, head of superyachts at VesselsValue, a shipping data provider. Superyachts are generally defined as a boat at least 80 feet in length.

Low interest rates helped to provide for cheap borrowing, while the stock market boom also created more wealth, Tucker added in a report titled "2021 Superyacht Market Performance" released last month and seen by Insider.

According to a study released last March by Americans for Tax Fairness and the Institute for Policy Studies, the collective wealth of 657 billionaires in the US grew by 44.6% — that's $1.3 trillion — during the pandemic.

While there was more money, there were fewer yachts to go around as shipyards were unable to significantly increase capacity due to global supply chain issues and a less efficient workforce due to pandemic movement restrictions, said VesselsValue's Tucker.

In 2021, fewer than 150 new yachts were delivered, far lower than over 350 in 2019, according to VesselsValue.

This has kept prices up in the secondhand market. Before the pandemic in 2019, a ten-year-old 60-meter Italian-built yacht could be bought for 20 million to 25 million euros ($22.9 to $28.6 million.) Today, the same vessel could fetch over 30 million euros ($34.3 million,) noted Tucker.

Superyachts are under the spotlight as Amazon founder Jeff Bezos' new $500 million yacht, currently known as Y721, is reportedly so big that the historic Koningshaven Bridge in the port city of Rotterdam may have to be temporarily dismantled just so the vessel can pass.

Some Dutch residents are apparently not amused, and are planning to throw eggs at the superyacht when it passes the location.
Vastly unequal US has world’s highest Covid death toll – it’s no coincidence

Melody Schreiber
Sun, February 6, 2022

Photograph: Saul Loeb/AFP/Getty Images

The US has suffered 900,000 deaths from Covid-19, the highest figure of any nation. The death toll would be equivalent to the 15th most populous city in the country, more than San Francisco, Washington DC or Boston – a city of ghosts with its population swelling each day.

It’s not just the total numbers. America also has the highest death rate of any wealthy country, with half of the deaths occurring after vaccines became available.

Related: The great gaslighting: how Covid longhaulers are still fighting for recognition

The US has never responded to the Covid pandemic in a sustained, proactive way as a unified nation. Instead, much of the responsibility – and blame – has fallen on individuals. In a country with vast income inequality, poor health and sharp political divides, the results have been grim.

“All of those factors put people at higher risk of Covid death,” said Megan Ranney, emergency physician and academic dean of public health at Brown University.

Vaccinations, in particular, have lagged, especially compared with other wealthy countries. The health system was already precarious when it began to be battered by wave after wave of Covid.

Other countries with similarly high death tolls earlier in the pandemic have seen fewer fatalities from the Omicron variant – yet in the US, the Omicron death toll is surpassing the Delta wave of autumn 2021. Last month was one of the deadliest of the entire pandemic.

Meanwhile, American leaders are attempting to mimic other countries’ return to normal, despite a markedly different situation with hospitalizations and deaths – which, every day, nearly reach the losses from the September 11 terrorist attacks.

“The first and most obvious [issue] is our vaccination and booster rate,” said Ranney. “Our rate of vaccination, period, is lower than in most other high-income countries, and our booster rate is lower as well. And as ample CDC data proves, vaccines and boosters are tremendously effective at protecting against death, even with Omicron.”

Less than two-thirds – about 64% – of Americans are vaccinated, and only 48% of those are boosted, despite ample vaccine supply.

For a country which has a vaccines-only strategy, we’re not very good at vaccination
William Hanage, associate professor of epidemiology

“For a country which has a vaccines-only strategy, we’re not very good at vaccination,” said William Hanage, associate professor of epidemiology at the Harvard TH Chan School of Public Health and co-director of the Center on Communicable Disease Dynamics. “There are large parts of the country which are not vaccinated to higher levels … and that’s made worse by the fact that with Omicron, to get really good protection, you also need to be boosted.”

Problems with access to vaccines linger, too. Better-off people have had plenty of opportunities to be vaccinated, but those in poorer households still struggle to get vaccines – and time off to recover from any side effects. Some 15% to 20% of unvaccinated Americans say they are still interested in getting their shots, Hanage said – they simply haven’t been able to yet.

Meanwhile, poorer unvaccinated people also face a “double whammy” because they are also more likely to contract Covid, he said.

“You have people who are more likely to be exposed to the virus, who are less likely to receive vaccines, who are less likely to be able to take steps to protect themselves even with vaccination, because they’re scared of missing a paycheck, they’re scared of taking a day off, their employer won’t let them.”

The US is the most economically unequal of G7 countries, and it offers no guaranteed sick leave.

“The absence of paid sick leave is an absolute scandal,” Hanage said. “If you care about working people, give them sick leave. That sick leave will enable them to avoid infecting others, it will enable them to help protect workplaces – it’s just a no-brainer.”

Another reason for the disparate outcomes in the US is the fractured healthcare system. People who lack health insurance tend to wait longer to be seen by physicians, making worse outcomes more likely. They are also more likely to have pre-existing health conditions that put them at greater risk for Covid.

“There are lots and lots of ways in which societal inequities are mirrored and magnified in our death rates,” Ranney said. “With Covid, there is now no longer any way to cover up all of these underlying problems, and the impact of those problems got magnified because many of the social supports which allowed us to muddle through were no longer present.”

The US also has higher rates of death from opioids and gun violence, and lower rates of life expectancy, than similar countries. Hospital overcrowding is also higher in the US than other countries, Ranney said.

“Overcrowding correlates with poor outcomes for multiple types of diseases and injuries,” she said. “And there’s been preliminary data that people are more likely to die of Covid when there’s a higher number of Covid patients in the hospital or when ICUs [intensive care units] are overwhelmed.”

One predictor of Covid deaths by country is trust in government, according to a recent report in the Lancet: countries with lower levels of trust in government had higher rates of cases and deaths.

“If you don’t trust the government, you’re less likely to follow suggestions or mandates around lockdowns, early on, or masks. And then the lack of trust also impairs governments’ ability to do important things like masking or testing or good data acquisition,” Ranney said.

Only 25 US states share reliable data on cases by age, which makes it difficult to know how many children are sick, for instance. “And then that hurts our ability to put data-driven public health measures in place, and then people don’t follow the public health measures, because they don’t trust them. And it becomes this circular problem,” Ranney said.

National leaders in the US are unable to mandate precautions, like masks or vaccines, for the entire country, with responsibilities largely falling instead to state and local leaders.

Yet leaders have seen their ability to act during health emergencies limited even more during the pandemic, with more than half of US states introducing new limits on public health powers.

“There is a constituency within the US that is beginning to look at this and see this opportunity,” Hanage said. “A lot of that comes down to: how much illness and death will people accept?”

Those who are interested in limiting public health regulations “are looking at this and thinking, whoa, a significant fraction of the population is fine with 900,000 deaths”.

There is still time to change course and prevent future losses, Ranney said.

“I do think that there’s a chance to create a better future,” she said, noting that leaders can “use this moment to build up the infrastructure that is needed, so if and when there is another variant or some other acute epidemic, we have the system in place to address it”.

But the US reaction to the pandemic is also compounded by an American sense of exceptionalism.

“It’s a very American idea to suggest that reality is what you want it to be. You can be whoever you want to be. Reality is a real thing, though. The virus doesn’t care who you are,” Hanage said. “It only cares that it can infect you.”
California attorney general accuses wealthy town of using mountain lions to skirt affordable housing law

Michael Finnegan
Sun, February 6, 2022,

State Atty. Gen. Rob Bonta says Woodside, a wealthy Silicon Valley town, is deliberately trying to shut off the supply of new housing within its borders by declaring itself a sanctuary for mountain lions like the one above in the Santa Monica Mountains. (National Park Service via AP)

State Atty. Gen. Rob Bonta accused managers of a posh Silicon Valley suburb on Sunday of trying to skirt new affordable housing requirements by declaring their town a sanctuary for mountain lions.

Woodside, an enclave in the foothills west of Stanford University, announced last month in a memo to its 5,500 residents that because the entire town was habitat for the potentially endangered mountain lion, it was exempt from a new law that permits duplex development on single-family home lots.

Bonta, a Democrat, called the move "a deliberate and transparent attempt to avoid complying with the law," known as SB 9.

"This memorandum is — quite clearly — contrary to the law, and ironically, contrary to the best interests of the mountain lions the town claims to want to protect," Bonta said.

By failing to help California expand its housing supply within existing towns, Woodside "would increase the likelihood of exurban sprawl that will adversely affect the habitat of mountain lions," Deputy Atty. Gen. Matthew T. Struhar told Woodside's town manager Sunday in a letter.

The town manager, Kevin Bryant, did not immediately respond to an email seeking comment, nor did the mayor, Dick Brown.

California wildlife regulators are weighing whether to declare mountain lions an endangered species.

Struhar's letter, sent on Bonta's behalf, said there was "no valid basis to claim that the entirety of Woodside is a habitat for mountain lions."

"Land that is already developed — with, for example a single-family home — is not, by definition, habitat," Struhar wrote, using italics for emphasis. "That mountain lions appear in Woodside from time to time does not make any of its individual parcels mountain lion habitat."

Struhar noted that the mountain lion's overall range includes "the vast majority of the San Francisco Bay Area."


California Atty. Gen. Rob Bonta. (Luis Sinco / Los Angeles Times)

"That breadth does not make nearly every single parcel in the San Francisco Bay Area a habitat for mountain lions, nor could the range of mountain lions, or any endangered species, be used to justify a local government's attempt to categorically prohibit a class of housing development within its local boundaries."

Struhar suggested it could "only be assumed" that Woodside's decree was "intended to undermine the Legislature's efforts to combat the crisis-level housing shortage."

The median home value in Woodside is $4.5 million. Its residents have included Oracle founder Larry Ellison, whose 23-acre estate there was modeled after a 16th century Japanese imperial palace.

The prospect of creating more affordable housing has long spurred strongly negative reactions in some California communities.

Woodside is one of about 40 communities in California that have passed new rules limiting housing projects since SB 9 went into effect on Jan. 1, according to YIMBY Law, a San Francisco group that urges local governments to approve more housing.

The new state law generally allows property owners of single-family parcels to build duplexes and, in some cases, fourplexes on their land. But lawmakers gave local governments discretion to add parking requirements or size limitations, among other restrictions.

Gov. Gavin Newsom and Bonta recently created specialized units to investigate cities that unlawfully deny housing projects or evade state laws.

Times staff writer Liam Dillon contributed to this report.
This story originally appeared in Los Angeles Times.

VIDEO

Florida jury orders R.J. Reynolds Tobacco Company to pay $9.75 million to family of a woman who died from respiratory disease caused by smoking cigarettes

Zahra Tayeb
Sun, February 6, 2022,

Carolyn Long was a regular smoker for decades before quitting in 2002.boonchai wedmakawand/Getty Images

R.J. Reynolds was ordered to pay $9.75 million to the family of a woman who died two years ago.

A Florida jury ruled that the firm's cigarettes and nicotine addiction caused Carolyn Long's death.

Despite trying everything she just couldn't quit, lawyers representing her husband told Insider.

A Florida jury awarded the family of a woman $9.75 million after she died from respiratory disease caused by smoking cigarettes.


Courtroom View Network (CVN) reported on the news.

Carolyn Long was a regular smoker for decades, before quitting in 2002. In the late 1990s, however, she was diagnosed with chronic obstructive pulmonary disease, which ultimately led to her death in 2020 at age 80.

The lawyers representing Long's husband, John, told Insider that Long had an extremely difficult time trying to quit smoking over the years. "Despite trying literally everything she just couldn't quit," said Shane Newlands of Florida-based law firm Newlands and Clark.

He added: "As we know now, nicotine rewires the brain in powerful ways when you start that young. The tobacco companies knew this long before the public did and engineered cigarettes to be as addictive as possible."

Long's husband told CVN that her illness and subsequent death were caused by R.J. Reynolds Tobacco Company's conspiracy to conceal the truth about the dangers of smoking.

R.J. Reynolds did not immediately respond to Insider's request for comment.

According to CVN, Reynolds' false marketing kept Long hooked on cigarettes. Lawyers told the outlet that Long smoked about half a pack a day for decades, before switching to a different brand selling an "ultra light" variation to be healthier.

In a statement to Insider, Newlands said the "light" cigarettes were marked as safer in the 70s and 80s. "We now know that was a lie," he said.

The switch led to Long smoking more than a pack of cigarettes a day, CVN reported. "That is the point of what the industry wanted. [They] don't want people to quit," lawyer Lee Clark, who is also representing Long's husband,said.

Elliot Pedrosa of American law firm Jones Day who represented R.J. Reynolds contended that Long smoked out of choice, not addiction. "Mrs. Long smoked when she wanted to, where she wanted to, and when she wanted to quit, she did that, too," Pedrosa said. "Smoking didn't control Mrs. Long. Mrs. Long controlled her smoking," he added.

But according to Newlands, the jury agreed Long was in fact addicted to cigarettes. "We're grateful that the jury listened so carefully to all the evidence and then placed a very significant value on what was a very significant loss for that family," Newlands said.

According to CVN, jurors apportioned 60% of responsibility to Reynolds and 30% to Long. Philip Morris, a cigarette company, was apportioned 10% of the responsibility, although it was not a party at trial.

Earlier this month, Cracker Barrel was ordered to pay $9.4 million to a man who was accidentally served toxic chemicals. But due to Tennessee laws, he is unlikely to receive the full amount, per a local news outlet.