Over 100 anti-vaccination protests showed up in New Zealand to support the parents of a critically ill 4-month-old baby in New Zealand who demanded that the hospital provide supplementary blood from unvaxxinated donors before the child goes under the knife for pulmonary valve stenosis, a heart valve disorder.
The boy's mother says she wants "safe blood" to be used, which her lawyer described as a fear of blood containing traces of vaccines using mRNA technology.
The request has been denied by New Zealand health service, which says vaccines pose no risk to donor supplies, according to RNZ. On Tuesday, the Auckland High Court will decide whether to grant a request to remove the child from the family to perform the surgery.
Paul White, a lawyer for Te Whatu Ora, aka Health New Zealand, described the baby as "getting sicker with every heartbeat."
Te Whatu Ora is making an application under the Care of Children Act regarding the baby who needs open heart surgery.
It is asking that the baby be placed under the guardianship of the court.
Te Whatu Ora then wants the court to appoint the doctors as agents of the court for medical care, and the parents agents of the court for all other care. -RNZ
According to White, a child with this condition would have been treated by now.
Supporters outside the High Court in Auckland where Te Whatu Ora is taking a case against parents who are refusing to allow blood from vaccinated people to be used during their baby's life-saving heart operation. Photo: RNZ / Marika Khabazi
Sue Grey, a lawyer for the family, said the doctors are dismissing the parents as conspiracy theorists and ignoring their concerns.
A full hearing on the matter will be held on Tuesday.
One supporter of the family, Sarah McNaulty, said she was standing up for freedom of choice.
"There's so many people lined up to give their blood freely," she said, adding "That is where tyranny starts. When the state provides us with not being able to give blood freely to a patient that needs it."
According to officials, the Blood Service does not segregate blood from vaccinated and unvaccinated donors, and that there is no risk from the Covid-19 vaccine.
Elon Musk’s Neuralink, a medical device company, is under federal investigation for potential animal-welfare violations amid internal staff complaints that its animal testing is being rushed, causing needless suffering and deaths, according to documents reviewed by Reuters and sources familiar with the investigation and company operations.
Neuralink is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments. The federal probe, which has not been previously reported, was opened in recent months by the US Department of Agriculture’s Inspector General at the request of a federal prosecutor, according to two sources with knowledge of the investigation.
The probe, one of the sources said, focuses on violations of the Animal Welfare Act, which governs how researchers treat and test some animals.
The investigation has come at a time of growing employee dissent about Neuralink’s animal testing, including complaints that pressure from CEO Musk to accelerate development has resulted in botched experiments, according to a Reuters review of dozens of Neuralink documents and interviews with more than 20 current and former employees. Such failed tests have had to be repeated, increasing the number of animals being tested and killed, the employees say. The company documents include previously unreported messages, audio recordings, emails, presentations and reports.
The investigation has come at a time of growing employee dissent about Neuralink’s animal testing, including complaints that pressure from Elon Musk to accelerate development has resulted in botched experiments.Neuralink/YouTube
Musk and other Neuralink executives did not respond to requests for comment.
Reuters could not determine the full scope of the federal investigation or whether it involved the same alleged problems with animal testing identified by employees in Reuters interviews. A spokesperson for the USDA inspector general declined to comment. US regulations don’t specify how many animals companies can use for research, and they give significant leeway to scientists to determine when and how to use animals in experiments. Neuralink has passed all USDA inspections of its facilities, regulatory filings show.
In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company’s animal-testing operations. The sources characterized that figure as a rough estimate because the company does not keep precise records on the number of animals tested and killed. Neuralink has also conducted research using rats and mice.
The total number of animal deaths does not necessarily indicate that Neuralink is violating regulations or standard research practices. Many companies routinely use animals in experiments to advance human health care, and they face financial pressure to quickly bring products to market. The animals are typically killed when experiments are completed, often so they can be examined post-mortem for research purposes.
But current and former Neuralink employees say the number of animal deaths is higher than it needs to be for reasons related to Musk’s demands to speed research. Through company discussions and documents spanning several years, along with employee interviews, Reuters identified four experiments involving 86 pigs and two monkeys that were marred in recent years by human errors. The mistakes weakened the experiments’ research value and required the tests to be repeated, leading to more animals being killed, three of the current and former staffers said. The three people attributed the mistakes to a lack of preparation by a testing staff working in a pressure-cooker environment.
A federal probe was opened in recent months by the US Department of Agriculture’s Inspector General at the request of a federal prosecutor.Getty Images
One employee, in a message seen by Reuters, wrote an angry missive earlier this year to colleagues about the need to overhaul how the company organizes animal surgeries to prevent “hack jobs.” The rushed schedule, the employee wrote, resulted in under-prepared and over-stressed staffers scrambling to meet deadlines and making last-minute changes before surgeries, raising risks to the animals.
Musk has pushed hard to accelerate Neuralink’s progress, which depends heavily on animal testing, current and former employees said. Earlier this year, the chief executive sent staffers a news article about Swiss researchers who developed an electrical implant that helped a paralyzed man to walk again. “We could enable people to use their hands and walk again in daily life!” he wrote to staff at 6:37 a.m. Pacific Time on Feb. 8. Ten minutes later, he followed up: “In general, we are simply not moving fast enough. It is driving me nuts!”
On several occasions over the years, Musk has told employees to imagine they had a bomb strapped to their heads in an effort to get them to move faster, according to three sources who repeatedly heard the comment. On one occasion a few years ago, Musk told employees he would trigger a “market failure” at Neuralink unless they made more progress, a comment perceived by some employees as a threat to shut down operations, according to a former staffer who heard his comment.
Five people who’ve worked on Neuralink’s animal experiments told Reuters they had raised concerns internally. They said they had advocated for a more traditional testing approach, in which researchers would test one element at a time in an animal study and draw relevant conclusions before moving on to more animal tests. Instead, these people said, Neuralink launches tests in quick succession before fixing issues in earlier tests or drawing complete conclusions. The result: More animals overall are tested and killed, in part because the approach leads to repeated tests.
Current and former Neuralink employees say the number of animal deaths is higher than it needs to be for reasons related to Musk’s demands to speed research.Neuralink/YouTube
One former employee who asked management several years ago for more deliberate testing was told by a senior executive it wasn’t possible given Musk’s demands for speed, the employee said. Two people told Reuters they left the company over concerns about animal research.
The problems with Neuralink’s testing have raised questions internally about the quality of the resulting data, three current or former employees said. Such problems could potentially delay the company’s bid to start human trials, which Musk has said the company wants to do within the next six months. They also add to a growing list of headaches for Musk, who is facing criticism of his management of Twitter, which he recently acquired for $44 billion. Musk also continues to run electric carmaker Tesla and rocket company SpaceX.
The Food and Drug Administration is in charge of reviewing the company’s applications for approval of its medical device and associated trials. The company’s treatment of animals during research, however, is regulated by the USDA under the Animal Welfare Act. The FDA didn’t immediately comment.
Missed deadlines, botched experiments
Musk’s impatience with Neuralink has grown as the company, which launched in 2016, has missed his deadlines on several occasions to win regulatory approval to start clinical trials in humans, according to company documents and interviews with eight current and former employees.
Some Neuralink rivals are having more success. Synchron, which was launched in 2016 and is developing a different implant with less ambitious goals for medical advances, received FDA approval to start human trials in 2021. The company’s device has allowed paralyzed people to text and type by thinking alone. Synchron has also conducted tests on animals, but it has killed only about 80 sheep as part of its research, according to studies of the Synchron implant reviewed by Reuters. Musk approached Synchron about a potential investment, Reuters reported in August.
Synchron declined to comment.
Musk’s impatience with Neuralink has grown as the company, which launched in 2016, has missed his deadlines on several occasions. Above, a screenshot from the Nov. 30 Neuralink presentation.Neuralink/YouTube
In some ways, Neuralink treats animals quite well compared to other research facilities, employees said in interviews, echoing public statements by Musk and other executives. Company leaders have boasted internally of building a “Monkey Disneyland” in the company’s Austin, Texas facility where lab animals can roam, a former employee said. In the company’s early years, Musk told employees he wanted the monkeys at his San Francisco Bay Area operation to live in a “monkey Taj Mahal,” said a former employee who heard the comment. Another former employee recalled Musk saying he disliked using animals for research but wanted to make sure they were “the happiest animals” while alive.
The animals have fared less well, however, when used in the company’s research, current and former employees say.
The first complaints about the company’s testing involved its initial partnership with University of California, Davis, to conduct the experiments. In February, an animal rights group, the Physicians Committee for Responsible Medicine, filed a complaint with the USDA accusing the Neuralink-UC Davis project of botching surgeries that killed monkeys and publicly released its findings. The group alleged that surgeons used the wrong surgical glue twice, which led to two monkeys suffering and ultimately dying, while other monkeys had different complications from the implants.
The company has acknowledged it killed six monkeys, on the advice of UC Davis veterinary staff, because of health problems caused by experiments. It called the issue with the glue a “complication” from the use of an “FDA-approved product.” In response to a Reuters inquiry, a UC Davis spokesperson shared a previous public statement defending its research with Neuralink and saying it followed all laws and regulations.
Screenshot from a Nov. 30 presentation the company broadcast on YouTube.Neuralink/YouTube
A federal prosecutor in the Northern District of California referred the animal rights group’s complaint to the USDA Inspector General, which has since launched a formal probe, according to a source with direct knowledge of the investigation. USDA investigators then inquired about the allegations involving the UC Davis monkey research, according to two sources familiar with the matter and emails and messages reviewed by Reuters.
The probe is concerned with the testing and treatment of animals in Neuralink’s own facilities, one of the sources said, without elaborating. In 2020, Neuralink brought the program in-house, and has since built its extensive facilities in California and Texas.
A spokesperson for the US attorney’s office for the Northern District of California declined to comment.
Delcianna Winders, director of the Animal Law and Policy Institute at the Vermont Law and Graduate School, said it is “very unusual” for the USDA inspector general to investigate animal research facilities. Winders, an animal-testing opponent who has criticized Neuralink, said the inspector general has primarily focused in recent years on dog fighting and cockfighting actions when applying the Animal Welfare Act.
‘It’s hard on the little piggies’
The mistakes leading to unnecessary animal deaths included one instance in 2021, when 25 out of 60 pigs in a study had devices that were the wrong size implanted in their heads, an error that could have been avoided with more preparation, according to a person with knowledge of the situation and company documents and communications reviewed by Reuters.
The mistake raised alarms among Neuralink’s researchers. In May 2021, Viktor Kharazia, a scientist, wrote to colleagues that the mistake could be a “red flag” to FDA reviewers of the study, which the company planned to submit as part of its application to begin human trials. His colleagues agreed, and the experiment was repeated with 36 sheep, according to the person with knowledge of the situation. All the animals, both the pigs and the sheep, were killed after the procedures, the person said.
In all, the company has killed about 1,500 animals, including more than 280 sheep, pigs and monkeys, following experiments since 2018, according to records reviewed by Reuters and sources with direct knowledge of the company’s animal-testing operations.Neuralink/YouTube
Kharazia did not comment in response to requests.
On another occasion, staff accidentally implanted Neuralink’s device on the wrong vertebra of two different pigs during two separate surgeries, according to two sources with knowledge of the matter and documents reviewed by Reuters. The incident frustrated several employees who said the mistakes – on two separate occasions – could have easily been avoided by carefully counting the vertebrae before inserting the device.
Company veterinarian Sam Baker advised his colleagues to immediately kill one of the pigs to end her suffering.
“Based on low chance of full recovery … and her current poor psychological well-being, it was decided that euthanasia was the only appropriate course of action,” Baker wrote colleagues about one of the pigs a day after the surgery, adding a broken heart emoji.
Baker did not comment on the incident.
Employees have sometimes pushed back on Musk’s demands to move fast. In a company discussion several months ago, some Neuralink employees protested after a manager said that Musk had encouraged them to do a complex surgery on pigs soon. The employees resisted on the grounds that the surgery’s complexity would lengthen the amount of time the pigs would be under anesthesia, risking their health and recovery. They argued they should first figure out how to cut down the time it would take to do the surgery.
“It’s hard on the little piggies,” one of the employees said, referring to the lengthy period under anesthesia.
In September, the company responded to employee concerns about its animal testing by holding a town hall to explain its processes. It soon after opened up the meetings to staff of its federally-mandated board that reviews the animal experiments.
Neuralink executives have said publicly that the company tests animals only when it has exhausted other research options, but documents and company messages suggest otherwise. During a Nov. 30 presentation the company broadcast on YouTube, for example, Musk said surgeries were used at a later stage of the process to confirm that the device works rather than to test early hypotheses. “We’re extremely careful,” he said, to make sure that testing is “confirmatory, not exploratory,” using animal testing as a last resort after trying other methods.
In October, a month before Musk’s comments, Autumn Sorrells, the head of animal care, ordered employees to scrub “exploration” from study titles retroactively and stop using it in the future.
Sorrells did not comment in response to requests.\Neuralink records reviewed by Reuters contained numerous references over several years to exploratory surgeries, and three people with knowledge of the company’s research strongly rejected the assertion that Neuralink avoids exploratory tests on animals. Company discussions reviewed by Reuters showed several employees expressing concerns about Sorrells’ request to change exploratory study descriptions, saying it would be inaccurate and misleading.
One noted that the request seemed designed to provide “better optics” for Neuralink.
A six-month study led by Johns Hopkins Medicine researchers concludes that the use of portable home air purifiers can improve some markers of cardiovascular health in people with chronic obstructive pulmonary disease, or COPD. People suffering from COPD often experience shortness of breath, chest tightness and chronic cough.
Cardiovascular diseases such as arrhythmias,heart failure, stroke andheart attackcommonly accompany COPD, and both COPD and cardiovascular disease are leading causes of death around the world, according to the World Health Organization.
The new research, described online in the American Journal of Respiratory and Critical Care Medicine, is a secondary study of a larger Johns Hopkins-led project, the CLEAN AIR study. The CLEAN AIR study, which investigated the effects of indoor air pollution on COPD, found that people with COPD experienced improved symptoms after using portable air purifiers indoors.
"We've seen that air pollution in the home, where people spend a majority of their time, contributes to impairments in respiratory health. We hypothesized this pollution is a big driver of cardiovascular disease and cardiac events in people with COPD," says lead author Sarath Raju, M.D., M.P.H., an assistant professor of medicine who specializes in obstructive lung diseases at the Johns Hopkins University School of Medicine.
Researchers recruited 85 men and women from the original CLEAN AIR study, who were adults (average age 65) with COPD. The participants lived primarily in the Baltimore area.
First, researchers had trained technicians take air samples of indoor particulate matter of varying sizes from participants' homes. These indoor air pollutants are composed of such things as mold and pet dander. One of the tiniest kinds of particulate matter, PM 2.5—smaller than the diameter of a human hair—can be detrimental to respiratory and heart health by infiltrating the bloodstream through the lungs and causing inflammation.
The level of PM 2.5 indoors should stay at or below 12 micrograms per cubic foot for the air to be considered healthy to breathe. Participants' homes had an average of 13.8 micrograms per cubic foot of PM 2.5.
Then, 46 randomized participants received two portable air cleaners with HEPA and carbon filters to use at home; the other participants received placebo air cleaners that circulated air but had the filters removed.
Researchers tracked and measured several indicators of lung and heart health at the one week, three-month and six-month periods of the study using standard clinical tests, such as blood pressure and heart ultrasounds (echocardiograms). Additionally, participants wore heart rate monitors for 24 hours during each clinical testing period, to assess heart rate variability.
At the end of the experiment, all 46 participants with active HEPA and carbon filters had improved markers of heart health, specifically a 25% increase in heart rate variability. Participants without the active filters saw no increase.
Heart rate variability, or HRV, is a common measure of heart health calculated using other statistical variables, such as the standard deviation between heart beats. HRV consists of changes in the time intervals between consecutive heart beats. A healthy heart is constantly adjusting its rate to meet the body's physical demands, and as such, has a higher heart rate variability.
Among 20 participants who used the air purifiers with active filters 100% of the time while at home, there was also a 105.7% increase in a heart health variability measure called the root mean square of successive differences between normal heartbeats, or RMSSD, which is associated with improved heart fitness.
The team also looked at the effects of ultrafine particles in the homes. These particles, smaller than a thousandth of a millimeter or one micron, are able to travel to the deepest part of the lungs when inhaled, and can even cross into the bloodstream.
In their evaluation of 29 participants and their homes, the researchers uncovered a correlation between an increase in ultrafine particles and poorer heart health markers, such as lower heart rate variability. The team says more research must be done in this area.
"Ultrafine particles might be the most potent particles in terms of health consequences," says study author Meredith McCormack, M.D., M.H.S., associate professor of medicine at the Johns Hopkins University School of Medicine and director of the BREATHE Center (Bridging Research, Lung Health and the Environment). "These particles and other indoor air pollutants can cause systemic inflammation in susceptible patients like those with COPD. Our study shows there's a negative impact on cardiovascular health, as well."
"In the future, air cleaners may be something to recommend to patients along with medications, but also can be part of a larger discussion about the importance of home environments," says Raju.
More information: Sarath Raju et al, Indoor Air Pollution and Impaired Cardiac Autonomic Function in Chronic Obstructive Pulmonary Disease, American Journal of Respiratory and Critical Care Medicine (2022). DOI: 10.1164/rccm.202203-0523OC
White House press secretary Karine Jean-Pierre on Monday suggested thatPresident Bidenwill fix "glitches" in the Inflation Reduction Act to assuage European concerns without going to Congress.
The comments came in response to a reporter who asked whether President Biden planned to issue any executive orders to tweak the IRA in response to criticism of the legislation from French officials over the weekend.
Jean-Pierre said the Biden administration was working through a "substantive consultation with Europe" to fix "glitches" and address their concerns, reiterating comments she made last week.
"We don’t have plans to go back to Congress on that. But when it comes to [Europe’s] concerns, of course, we’re going to have conversations with our European allies," Jean-Pierre said.
Foreign officials have accused the IRA, passed in August, of being "protectionist." French President Emmanuel Macron, who dined with Biden during a state visit last week, has complained that subsidies meant to incentivize semiconductor production for electric vehicles have put European leaders at an unfair disadvantage.
Speaking at a joint press conference with Macron, Biden acknowledged the $368 billion spending and tax law may have "glitches" but overall defended what the White House views as a signature achievement of his administration.
"Look, the United States makes no apology and I make no apology, since I wrote it, for the legislation you're talking about," Biden said in response to a reporter's question about the complaints.
"But there are occasions when you write a massive piece of legislation – and that has almost $368 billion for the largest investment in climate change in all of history – and so there's obviously going to be glitches in it."
Videotaped Deposition of DR. ANTHONY FAUCI, a
14 Defendant herein, called for examination by counsel
15 for Plaintiffs in the above-entitled matter, pursuant
16 to notice, the witness being duly sworn by Stephanie
17 Barnes, a Notary Public in and for the State of
18 Maryland, taken at the offices of National Institutes
19 of Health, 31 Center Drive, Building 31, Bethesda,
20 Maryland, at 8:08 a.m., Wednesday, November 23, 2022,
21 and the proceedings being taken down by Stenotype by
22 Stephanie Barnes, and transcribed under her
23 direction.
Pfizer Inc and its German partner BioNTech SE fired back at Moderna Inc with counterclaims in a patent lawsuit in Boston federal court on Monday over their rival COVID-19 vaccines, seeking dismissal of the lawsuit and an order that Moderna's patents are invalid and not infringed.
Moderna first sued Pfizer in August, accusing the company of violating its rights in three patents related to innovations that Cambridge, Massachusetts-based Moderna said it pioneered before the COVID-19 pandemic.
Moderna has also filed a related lawsuit against Pfizer and BioNTech in Germany. All three companies are also embroiled in U.S. patent disputes with other companies over the vaccines.
The companies did not immediately respond to requests for comment on the Monday filing.
Pfizer's COVID-19 vaccine made over $26.4 billion for the New York-based company in the first nine months of 2022, while Moderna sold over $13.5 billion worth of its COVID vaccine over the same period, according to company filings with the U.S. Securities and Exchange Commission.
NE3107-treated patients experienced greater motor control in Parkinson’s trial
Patients treated with the combination of NE3107 and levodopa saw improvements in their UPDRS Part 3 (motor) score that is 3+ points superior to patients treated with levodopa alone. This level of superiority is considered to be clinically meaningful by Parkinson’s experts.
Patients under 70 years of age treated with NE3107/levodopa experienced roughly 6 points superiority compared to those treated with levodopa alone, suggesting that younger patients with less advanced disease progression may experience greater impact from treatment with NE3107.
88.9% of patients <70 years old treated with NE3107 and levodopa experienced greater than 30% part 3 score improvements from baseline at the 2-hour mark compared to 63.6% of patients treated with levodopa alone.
The study met both of its objectives.
NE3107-treated patients experienced improved cognition and biomarker levels in Alzheimer’s trial
Patients treated with NE3107 experienced enhanced cognition as measured by multiple assessment tools, including a 2.1 points improvement on the modified ADAS-Cog12 scale (p=0.0173) among MCI and mild Alzheimer’s Disease (AD) patients
NE3107 reduces CSF phospho-tau levels by -1.66 pg/mL (p=0.0343) and the ratio of p-tau to Aβ42 by -0.0024 (p=0.0401)
18 of 22 patients with abnormal baseline scans showed improvement in one or more brain regions as seen from advanced functional MRI studies
