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Monday, March 6, 2023

Matt Hancock’s Plan To "Deploy The New Variant" To "Frighten The Pants Off Everyone"

 by Nick Dixon via The Daily Sceptic,

The latest of the Telegraph’s ‘Lockdown Files’ has arrived, and impressively it is even more damning than the previous instalments. Here’s an excerpt:

Throughout the course of the pandemic, officials and ministers wrestled with how to ensure the public complied with ever-changing lockdown restrictions. One weapon in their arsenal was fear

“We frighten the pants off everyone,” Matt Hancock suggested during one WhatsApp message with his media adviser. 

The then Health Secretary was not alone in his desire to scare the public into compliance. The WhatsApp messages seen by the Telegraph show how several members of Mr. Hancock’s team engaged in a kind of ‘Project Fear’ in which they spoke of how to utilise “fear and guilt” to make people obey lockdown.

As with the other revelations, it is shocking yet not surprising. We knew they were doing this, but there’s something truly grotesque about seeing the contempt they had for people laid bare. The absolute disregard for freedom, and worse, the revelling in this exercise of power by the likes of Simon Case, the Cabinet Secretary, who found forcing travellers to quarantine in shoebox hotel rooms “hilarious”.

It is a toss up between Hancock and Case for the title of the Lockdown Files’ Greatest Villain. I was considering awarding it to the wretched Case until this latest round of files dropped, and Hancock went full Dr. Evil with his question: “When do we deploy the new variant” [sic].

Of course we shouldn’t let the unintentional comedy of Hancock’s messages (one has him text shouting “SOMEONE INSTALLED A CAMERA IN MY OFFICE WITHOUT TELLING ME!”) distract from how appalling his actions were.

How far Boris should be excused is another question. Throughout the Lockdown Files he shows his instinct for freedom, but lacks the courage to convert that into policy. This latest episode is no different, as the Telegraph reveals:

Boris Johnson, then the Prime Minister, had promised that families would be reunited at Christmas – the first since the pandemic struck in early 2020. He said foregoing long-awaited reunions “would be inhuman and against the instincts of many people in this country”.

But behind the scenes, his ministers and officials were increasingly aware that vast swathes of the public faced a grave disappointment and that the Johnson administration would take the blame for their frustration. 

The solution in December was “to frighten the pants off everyone” with a declaration of a new strain of COVID-19, known as the Alpha or Kent variant.

In a conversation between Mr Hancock and Mr Poole on Dec 13th, the pair discussed how to survive the coming backlash and storm. On the day, there were 18,409 cases of Covid recorded and 410 deaths. Five days later, on Dec 18th, Mr. Johnson would scrap his planned five-day Christmas amnesty in an about turn. 

Every time I think I have hit peak anger with this ongoing saga, the messages reveal a new low.

The bizarre power given to chancers “Slackie and Lee” (James Slack and Lee Cain in the Downing St comms team) to dictate policy; Simon Case’s nauseating glee at imposing petty restrictions, and his characterisation of the desire to retain basic privacy around one’s contact details as “pure Conservative ideology”; Boris’s claim that another lockdown would be the “height of absurdity”, before immediately implementing it – I could go on.

But Hancock’s brazen fear tactics, apparently divorced from any kind of scientific evidence, deployed, to use his word, with borderline psychopathic disregard for the impact they would have on people, is the worst finding yet in this already incredibly sordid tale.


Non-surgical treatment significantly reduces knee pain

  Genicular nerve radiofrequency ablation is a minimally invasive treatment for knee pain due to osteoarthritis of the knee, and can significantly reduce pain, especially for adults who are 50 and older, according to new research to be presented at the Society of Interventional Radiology Annual Scientific Meeting in Phoenix. This is the first time a study has examined patient demographics, prior surgical history and other clinical characteristics that may predict the level of pain reduction after treatment.

"We know this treatment has clear benefits in reducing pain and improving the ability to do everyday activities for patients," said Kaitlin Carrato, M.D., chief resident in interventional radiology at MedStar Georgetown University Hospital. "But now that we know it's particularly helpful for those over 50 years old, it may mean that those with chronic pain conditions, like arthritis, would benefit more from this treatment than patients suffering acute pain, such as an injury."

Interventional radiologists perform genicular nerve radiofrequency ablation by image guidance to place probe needles next to the nerves of the knee that can send pain signals to the brain. The probes generate radio waves, creating a ball of heat to dull or destroy the pain nerve endings. These nerves do not control muscles or affect balance, making the procedure safe. Furthermore, patients leave with Band-Aids, not stitches. The treatment in other studies has been shown to last for approximately six months to up to two years.

The study examined pain reduction for 36 patients using the visual analog scale (VAS) and the Western Ontario McMaster Universities Osteoarthritis (WOMAC) pain scale. Researchers evaluated whether pain reduction levels were influenced by demographics and clinical characteristics, such as age, gender, body mass index, history of prior surgery and history of fibromyalgia.

Before treatment, patients had a mean baseline VAS of 8.58 and a mean baseline WOMAC of 66.6. After treatment, all study participants experienced a statistically significant reduction in pain. The mean VAS of 8.58 decreased to 5.02, while the mean WOMAC score decreased from 66.6 to 41. The greatest increase in functionality and decrease in pain was recorded for patients 50 and older compared to younger participants.

"Roughly one in four U.S. adults have knee pain," said John B. Smirniotopoulos, M.D., an interventional radiologist at MedStar Georgetown University Hospital. "This treatment can offer many of those people a chance to enjoy everyday activities and regain a higher quality of life by decreasing the pain that they experience on a daily basis."

The researchers are currently conducting long-term studies into this treatment that dive deeper into what other factors could predict how well the treatment will work. The same treatment is also conducted with shoulder, hips and sacroiliac joints, where the spine connects to the pelvis.

Abstract 120: Genicular Nerve Radiofrequency Ablation: Is there a Predictor of Outcomes? K. Carrato, N. Jain, A. Eckert, M. Lamberti, C. Sutton, J. Sens, K. Horton, A. Khan, N. Tabori, G. Sivananthan, J. Smirniotopoulos. Annual Scientific Meeting, March 4-9, 2023. 

https://www.biospace.com/article/releases/non-surgical-treatment-significantly-reduces-knee-pain-for-adults-especially-those-50-and-older/

FDA Action Alert: Roche and Acadia

 After the flurry of verdicts and meetings at the end of February, the FDA has a relatively quiet week ahead with only two stand-out events.

Roche Pushes Polivy into the Frontline

On March 9, the FDA’s Oncologic Drugs Advisory Committee will convene to discuss Genentech’s supplemental Biologics License Application for Polivy (polatuzumab vedotin-piiq), the biotech’s anti-CD79b antibody-drug conjugate. Genentech is a Roche company.

Genentech is proposing to use Polivy, in combination with the R-CHP regimen, to treat patients with diffuse large B-cell lymphoma (DLBCL) who have not received prior lines of treatment.

To support its first-line bid, Genentech offered data from the Phase III POLARIX trial, which it submitted along with the sBLA in August 2022. The study showed Polivy plus plus R-CHP cut the risk of disease progression, relapse or death by 27% as compared with the R-CHOP regimen, the current standard of care in DLBCL.

Polivy plus R-CHP had a similar safety profile as R-CHOP.

With these results, POLARIX became the first study in 20 years to demonstrate a clinically meaningful improvement in progression-free survival over standard of care, Genentech reported. The FDA is expected to reach a formal verdict on Polivy’s sBLA by April 2, 2023.

In 2019, The FDA greenlit Polivy for the treatment of DLBCL that had progressed or returned after at least two prior lines of therapy.

Acadia Readies for Landmark Rett Ruling

Acadia Pharmaceuticals is hoping to notch an approval for its Rett syndrome candidate trofinetide, which has an FDA action date of March 12. Acadia is developing trofinetide in partnership with Neuren Pharmaceuticals.

If approved, trofinetide would be the first drug for Rett syndrome, an ultra-rare, multisystem neurodevelopmental disorder characterized by developmental regression, loss of language and hand function, and impaired gait. It primarily affects female children.

Trofinetide is an investigational and novel synthetic analog of the amino‐terminal tripeptide domain of the IGF-1 protein. It works by preventing the overactivation of microglia and astrocytes, promoting synaptic function and reducing neuroinflammation.

Acadia submitted the New Drug Application for trofinetide in September 2022 and backed it up with data from the Phase III Lavender study, which compared the candidate against placebo in 187 girls and young women.

The co-primary endpoints – change in Rett Syndrome Behavior Questionnaire scores from baseline and Clinical Global Impression-Improvement scale score – were significantly improved after trofinetide treatment, as compared with placebo. Lavender also hit key secondary endpoints.

The FDA granted trofinetide priority review, Fast Track Status, Orphan Drug and Rare Pediatric Disease designations.

This will be the second decision for the FDA’s Office of Neuroscience following the abrupt departure of its former head, Billy Dunn.

https://www.biospace.com/article/fda-action-alert-roche-and-acadia-/

Deporting Fentanyl Dealers Violates Sanctuary City Policies, Says SF Supervisor

 by Brad Jones via The Epoch Times (emphasis ours),

San Francisco County Supervisor Shamann Walton told San Franciscans this week the U.S. shouldn’t deport illegal immigrant drug dealers for selling fentanyl, the deadly synthetic opioid that was largely responsible for nearly 2,000 drug overdose deaths in the city since 2020.

“There’s been a drug issue in this country for a very long time. But there’s no way we’re going to stand by and allow people to say that one race or immigrants are responsible for these fentanyl deaths,” Walton said at a rally on the steps of City Hall on Feb. 28.

Walton defended the city’s sanctuary policies that prohibit city authorities from assisting U.S. Immigration and Customs Enforcement (ICE) in response to a proposal by Supervisor Matt Dorsey to add fentanyl crimes to a list of violent crimes the city uses for cooperating with ICE. Dorsey’s proposal aligns with a recent push for a crackdown on fentanyl dealers initiated by District Attorney Brooke Jenkins.

Homeless people gather near drug dealers in the Tenderloin District of San Francisco, Calif., on Feb. 22, 2023. (John Fredricks/The Epoch Times)

You cannot violate sanctuary policy for any reason. It goes against the morals of our fabric here in San Francisco, and it also allows people who don’t share our values to persecute people that need us the most,” Walton said at the rally. “People are going crazy over fentanyl because we’re starting to see more white people die from this drug. Where the hell were these people when my mothers and my grandmothers were on crack?”

J.J. Smith lives in the city’s infamous Tenderloin district, a hotspot for drug use, and he lost his brother to a fentanyl overdose in October. He told The Epoch Times on March 2 that Walton’s remarks came as “a shock” and “didn’t set well with a lot of people, even the black community.”

Smith said it’s no secret that drug dealers with connections to Honduras largely control the illicit fentanyl trade in the Tenderloin, which is not directly affecting Walton’s district.

Honduran dealers “are the only people in San Francisco that have large quantities of fentanyl,” he claimed. “We should care because it’s killing everybody, not only white people. And, even if it does kill only white people, who is to say that’s fair?”

Smith questioned the logic behind lesser punishments for fentanyl dealers when crack dealers in the 1980s and 1990s, including African Americans, were handed long prison sentences for their crimes.

“But now Walton is speaking about a deadly drug that’s killing more people than any drug that’s ever been on the market,” he said.

A homeless man sits passed out next to an empty syringe in San Francisco, Calif., on Feb. 23, 2023. (John Fredricks/The Epoch Times)

Jacqui Berlinn, co-founder of Mothers Against Drug Addiction and Deaths, told The Epoch Times she was offended by Walton’s comments.

Berlinn said she was a child during the crack cocaine epidemic of the 1980s, but that she is now fighting for her son Corey, who is addicted to fentanyl, and “for all citizens of all races” affected by the “poison flooding our cities.”

“We have members fighting with us who are black,” she told The Epoch Times in a text message. “Fentanyl is killing U.S. citizens of all races—disproportionately persons of color. It’s also poisoning U.S. children that had no idea what they were getting. There has never been a drug market so deadly as the one we are experiencing now.”

San Francisco was among the first 12 U.S. cities to declared itself a sanctuary city, prohibiting local police from stopping or arresting people based on their immigration status.

Walton was speaking at a noon rally in support of Supervisor Hillary Ronen’s proposed resolution denouncing criticism of sanctuary city policies at City Hall ahead of the Feb. 28 Board of Supervisors meeting. Supervisors Myrna Melgar and Dean Preston also attended the rally.

After nearly two hours of public comments, the board voted unanimously to continue debate on the issue at its next meeting on March 7.

San Francisco Public Defender Mano Raju said at the rally that city police unfairly target black and brown dealers and that the “war on drugs” was designed to target black and brown people for arrest and incarceration, while white dealers are rarely arrested.

“We also know that Latin X community members who are targeted are young and often survivors of labor, trafficking, and exploitation. Using our local resources to funnel these individuals to ICE detention facilities will subject them to horrific conditions that can lead to a death sentence for deportation,” he said. “And, all this cruelty is going to do nothing to stem the overdoses.”

Dorsey did not respond to requests for comment.

https://www.zerohedge.com/political/deporting-fentanyl-dealers-violates-sanctuary-city-policies-says-sf-supervisor

Roche receives FDA approval of label expansion for VENTANA PD-L1 (SP263) Assay

 

  • The VENTANA PD-L1 (SP263) Assay helps determine which patients with non-small cell lung cancer (NSCLC) may be eligible for treatment with Libtayo monotherapy1 based on the results of the Phase III EMPOWER-Lung 1 study.

  • This additional approval will allow more patients with locally advanced and metastatic NSCLC broader access to the immunotherapy Libtayo.

  • PD-L1 testing provides clinicians with essential information that helps guide clinical decision making and improve patient outcomes.

Biogen, Eisai: Priority Review for Traditional Approval of LEQEMBI™ (lecanemab-irmb) for Alzheimer's

 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's supplemental Biologics License Application (sBLA) for LEQEMBI™ (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.

LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ), approved under the Accelerated Approval Pathway for the treatment of Alzheimer's Disease (AD) on January 6, 2023. Treatment with LEQEMBI should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology. On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.

https://finance.yahoo.com/news/fda-accepts-eisais-filing-supplemental-233000498.html

AstraZeneca says cancer drug Enhertu showed positive results

 AstraZeneca PLC on Monday said its cancer drug Enhertu has shown clinically meaningful and durable responses across multiple HER2-expressing advanced solid tumors in its DESTINY-PanTumor02 Phase II trial.

The Anglo-Swedish pharma major (AZN.LN) said Enhertu--trastuzumab deruxtecan, which it is jointly developing and commercializing with Daiichi Sankyo--had met prespecified criteria for objective response rate and duration of response.

"Enhertu has already demonstrated its potential to improve outcomes for patients with HER2-targetable breast, gastric and lung cancers, and these positive initial results in other tumor settings with significant unmet need are very encouraging," said Chief Medical Officer and Oncology Chief Development Officer Cristian Massacesi.

https://www.morningstar.com/news/marketwatch/2023030629/astrazeneca-says-cancer-drug-enhertu-showed-positive-results