Search This Blog

Monday, April 3, 2023

Nashville shooter fired 152 rounds, planned attack ‘over a period of months’

 Nashville school shooter Audrey Hale fired 152 rounds during her 14 minute assault on the Covenant School which left six dead, officials have announced.

The shooter, who police said was transgender, had planned the attack for months before blasting her way into the Nashville private elementary school on the morning of March 27.

“In the collective writings by Hale found in her vehicle in the school parking lot, and others later found in the bedroom of her home, she documented, in journals, her planning over a period of months to commit mass murder at The Covenant School,” the Metro Nashville Police Department said.

Police also revealed Monday Hale, 28, had “considered the actions of other mass murderers.”

They noted Hale fired 152 rounds from the two assault rifles and a pistol she carried
for the attack.

Audrey Hale

Nashville shooter Audrey Hale
MNPDNashville/Twitter

Police previously said Hale had targeted the school, but not the victims. Hale also “explored” other locations, including two public schools, before carrying out the Covenant killing spree, officials have previously said.

Surveillance footage from the exterior of the school showed Hale shooting into the school’s locked side doors and crawling in through the shattered glass.

Hale was then seen stalking through the empty halls of the school as 911 calls poured in.
The chilling calls, which police released to NewsChannel5 Nashville, paint a chilling picture of the fear felt among students and staff as they hid from the heavily armed attacker.

Police outside Covenant school
Hale’s massacre at the school left six dead.
AP

In the second of three 911 calls released, an adult woman’s voice can be heard amid the sound of an alarm blaring in the background.

“I think we hear gunshots,” she tells the dispatcher in the call, which was placed at 10:12 a.m. local time.

Someone who sounds like a child can be heard whimpering in the background.

Children led away from the school
The assault lasted approximately 14 minutes, according to officials.
AP

Moments later, someone can be heard saying they “want to go home.”

Asked if the woman was in a safe spot, she responds: “I think so.”

“We’re in the art room closet. I hear another shot, I’m hearing more shots.”

Audrey Hale
Nashville school shooter Audrey Hale fired 152 rounds during the assault.
Nossi College of Art

Police body camera footage shows the team of MNPD officers rushing into the building and disarming the shooter within minutes.

Officers Rex Engelbert and Michael Collazo each fired four rounds, ultimately killing Hale, police said.

Nine-year-olds Evelyn Dieckhaus, Hallie Scruggs and William Kinney were killed in the
assault, as well as school janitor Mike Hill, substitute teacher Cynthia Peak and headmistress Katherine Koonce, who reportedly ran toward the shooter to try to protect the school.

A local official told The Post that the FBI’s Behavioral Analysis Unit is reviewing Hale’s manifesto. Police are still investigating Hale’s possible motive.

https://nypost.com/2023/04/03/nashville-shooter-audrey-hale-planned-attack-over-a-period-of-months-officials/

US FDA approval and panel tracker: March 2023

 Last month was a busy one for FDA advisory committee meetings. Following Pfizer’s earlier positive panel with its respiratory syncytial virus vaccine Abrysvo, this time it was GSK’s turn with Arexvy, with its own vote looking more favourable. Several issues such as safety, durability and reimbursement have yet to play out, but both GSK and Pfizer’s vaccines look likely to gain approval in May. The highly competitive space saw Johnson and Johnson shelve its own phase 3 vaccine project in late March. In another adcom, Roche’s Polivy came away with a positive decision in first-line diffuse large B-cell lymphoma. The outcome was a surprise because briefing documents had focused on the lack of a survival benefit, and modest PFS. Polivy's Pdufa was set for 2 April. Lastly, Biogen/Ionis’s tofersen could be heading for accelerated approval in Sod1-mutated ALS after a panel voted unanimously in favour of using data from a controversial biomarker to predict a clinical benefit. Tofersen’s Pdufa is 25 April.

Notable first-time US approval decisions in March
ProjectCompanyIndication(s)2028e SBI ($m)Outcome
Valrox (Roctavian)BiomarinHaemophilia A gene therapy1,420Delayed to June 30 (previously submitted three-year data analysis)
ABBV-951 (foscarbidopa/foslevodopa for continuous subcutaneous delivery)AbbvieTreatment of motor fluctuations in adults with advanced Parkinson's disease.979CRL (additional information about the device)
Zavzpret (zavegepant)Pfizer (Biohaven)Acute treatment of migraine562Approved
Rezzayo (rezafungin)Cidara/Melinta/ MundipharmaCandidemia and invasive candidiasis in adults who have limited or no alternative treatment options348Approved
Daybue (trofinetide)AcadiaRett273Approved
Joenja (leniolisib)Pharming/NovartisActivated phosphoinositide 3-kinase delta syndrome189Approved
Zynyz (retifanlimab)IncyteAdults with metastatic or recurrent locally advanced Merkel cell carcinoma -Approved (previous CRL in squamous cell carcinoma of the anal canal)
SBI: sales by indication. Source: Evaluate Pharma & company releases.

 

Advisory committee meetings in March
ProjectCompanyIndication2028e SBI ($m)Outcome
PaxlovidPfizerMild-to-moderate coronavirus
disease in adults who are at high risk for progression to severe Covid-19,
including hospitalisation or death
4,86716 to 1 in favour
Arexvy (RSVPreF3 OA)GSKPrevention of lower respiratory tract disease caused by RSV-A and RSV-B subtypes in adults 60 years of age and older (recombinant, adjuvanted vaccine)1,742In favour: efficacy (12-0), safety (10-2)
PolivyRocheIn combo with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for the treatment of adult patients with previously untreated diffuse DLBCL1,497*11 to 2 in favour
TofersenBiogen/IonisALS associated with a mutation in the SOD1 gene109 to 0 in favour of using biomarker data to predict clinical benefit in accelerated decision
Naloxone hydrochloride nasal spray, 3 mg/0.1 mL (Rivive)Harm Reduction TherapeuticsNonprescription use as an opioid reversal agent in the emergency treatment of opioid overdose-Cancelled, no longer needed
*Already approved in 3L use. Source: Evaluate Pharma, company releases & FDA adcom calendar.

 

Supplementary and other notable approval decisions in March
ProductCompanyIndication (clinical trial)Outcome
Narcan nasal spray (4 mg/0.1 mL)Emergent BiosolutionsOTC emergency treatment for known or suspected opioid overdose.Approved
Naloxone hydrochloride nasal spray 4mgAmphastarEmergency treatment of known or suspected opioid overdoseApproved
EvkeezaRegeneronAdjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolemia (NCT04233918)Approved
Hyrimoz (high concentration formulation of 100 mg/mL) (Humira biosimilar)NovartisIncludes the indications of the reference medicine HumiraApproved
Verzenio + endocrine therapyEli LillyAdjuvant HR+ Her2- node-positive, early breast cancer at a high risk of recurrence (four-year data from monarchE)Approved
Tafinlar + MekinistNovartisPaediatric patients with BRAF V600E low-grade glioma (Tadpole)Approved
Nelarabine injection (SH-111)Shorla Oncology (private)T-cell acute lymphoblastic leukaemia and T-cell lymphoblastic lymphoma Approved (ANDA)
KeytrudaMerck & CoAdult and paediatric patients with unresectable or metastatic MSI-H or dMMR solid tumoursConversion to full approval (Keynote-158-164-051)
Pfizer-BioNTech Covid-19 Vaccine, BivalentPfizer/BiontechSingle booster dose of the vaccine in children 6 months to 4 years old (at least 2 months after completion of primary vaccination)EUA amended
Empaveli injectorApellisPNH (on-body drug delivery system that would enable patients to self-administer pegcetacoplan through subcutaneous infusion)Extended (timing TBC)
Lynparza + Zytiga + prednisone/prednisoloneAstrazenecaMetastatic castration-resistant prostate cancer (Propel)Delayed, adcom set for 28 April
SabizabulinVeruHospitalised adult patients with moderate to severe Covid-19 who are at high risk for acute respiratory distress syndromeDeclined EUA (negative adcom in November 2022)
MakenaCovis (private)Reducing risk of preterm birth in women who have a history of singleton spontaneous preterm birthTo be withdrawn, follows second negative adcom last Oct
QD (once daily) ruxolitinib (Jakafi) extended release formulationIncyteMyelofibrosis, polycythemia vera and GVHDCRL
ANDA; abbreviated NDA. Source: Evaluate Pharma & company releases.

https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-and-panel-tracker-march-2023

Kiromic Submits Application for Phase 1 Trial for Non-Small Cell Lung Cancer

 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, announces the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial to evaluate KB-GDT-01, or Deltacel, in combination with an anti-tumor therapy for the treatment of non-small cell lung cancer (NSCLC).

Deltacel is the Company’s allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cell (GDT) therapy. The Company is seeking to address the significant unmet need of applying cell therapy to treat solid malignancies, which comprise 90% of all cancers, including NSCLC.

https://finance.yahoo.com/news/kiromic-biopharma-submits-investigational-drug-120800876.html

Legislators Should Reject the WHO’s Proposals for Pandemics

 Democracies and sane societies are built on rationalism and honesty. They may not always exhibit this, but these values must underpin major decisions. Without them, neither democracy nor justice are sustainable. They are replaced by a structure in which the few dictate to the many, and the excesses of feudalism, slavery or fascism rise to dominance. This is why so many fought so hard, for so long, in defense of these ideals. People in democratic countries then elect representatives to the privileged position of guardians of their freedom.

The World Health Organization (WHO) is promoting a pandemic treaty (‘CA+’), and amendments to the existing International Health Regulations (IHR), to increase its power during health emergencies. These proposals also broaden the scope of emergencies to include potential rather than actual harm. The draft treaty suggests a definition of ‘One Health’ that encompasses any occurrence in the biosphere that could impact human well-being. This decision-making power will be placed in the hands of a single person, the WHO Director General. The WHO will require countries to sign on to these agreements to suppress and censor the voices of those who question the Director-General’s dictates. 

The two proposals, detailed elsewhere, aim to expand an international bureaucracy for health emergencies with an additional annual budget estimated by the World Bank at three times the WHO’s current budget. This program is heavily backed by the WHO’s major individual and corporate sponsors, entities that will directly benefit through the commodity-centered responses that are proposed. However, it will be mainly funded by taxpayers.

This is a new model for the WHO and for public health. The WHO was originally intended to serve countries, not instruct them. The proposals aim to reduce individual and national decision-making power, or sovereignty, replacing this with obedience to the WHO’s recommendations. When the WHO Director-General recently suggested that the above was untrue, he was not reflecting the WHO’s proposals, but a separate, public messaging campaign. In WHO parlance, he was spreading misinformation.

Individual sovereignty and human rights were once central to public health. These concepts are commonly exercised through elected representatives, and through retention of inalienable rights of a person in decisions over their own body. Anti-fascist agreements such as the Nuremberg Code are based on this understanding. These alone are compelling reasons to oppose these WHO proposals. But there are other compelling reasons why these proposals are both ridiculous and dangerous.

Developing a drug cartel 

Much of the WHO’s funding comes from private and corporate sponsors, who specify how their money will be used. The companies have responsibility to their shareholders to use this relationship to increase profits, whilst individuals are directly invested in companies that will gain from the WHO’s health emergency proposals. We saw this during Covid-19.

A lack of interest from major media, which derive their largest private advertising revenue from the same companies, should not be taken as a reason to ignore it. The WHO’s sponsors seek to profit by it taking control of potentially profitable aspects of health away from representative governments, so that their products can be mandated for use more broadly, and more often.

Undoing democracy

It is right and fair that all countries should be represented at the World Health Assembly. However, much of the world’s population lives under authoritarian governments and military dictatorships. The current WHO Director-General was a minister in a dictatorial government. This is fine for an organization that convenes meetings and names diseases. But it is obviously inappropriate for a democratic country to cede authority over its own citizens to such an entity, and to unaccountable international officials subject to conflict of interest, influences, and biases. 

Public health responses should depend entirely on a population’s own values and priorities, not that of foreign dictators or their appointees. It would be stupid to give control to those espousing quite opposite values.

Obvious incompetence

Before entrusting one’s health to others, it is essential to know that they are competent. Despite having previous evidence-based guidelines for pandemics, the WHO lost the plot disastrously with Covid-19. It supported policies that have worsened such diseases as malariatuberculosis and malnutrition, and increased debt and poverty to lock in poorer health for the next generation. These policies increased child labor and facilitated the rape of millions of girls forced into child marriage, whilst denying formal education to hundreds of millions of children. Sick elderly people were unable to get care, while healthy people were confined at home. They have promoted the largest upwards concentration of wealth, and its consequent mass impoverishment, in history.

For the past two years, the WHO has embarked on a project to mass vaccinate 70 percent of African populations, despite half the population being under 20 years of age so at minimal risk, and the WHO’s own study showing the vast majority had already had Covid-19. This program is the most expensive, per year, that the WHO has ever promoted. It is now seeking powers that will enable them to repeat these types of responses, often.

Disdain for human rights

Countries adopting the proposed IHR amendments will accept WHO recommendations as obligatory. The list covered in the IHR includes border closures and refusal of individual travel, isolation of ‘suspect’ persons, required medical examinations and vaccination, exit screening and requirements of proof of testing. These will be imposed on a country’s own citizens when an individual in this organization sponsored by large multinational corporations and wealthy investors decides, independently, that an undefined health ‘threat’ poses a risk to other countries.

There are no clear criteria for ‘risk,’ and no need to demonstrate harm, for this draconian removal of basic human rights to be imposed. The WHO Director General will not even have to consult and obtain wider consent. Other initiatives are underway to ensure that the required vaccinations will not need to undergo normal safety testing. There is no soul-searching regarding the devastation caused to individuals and economies through similar policies implemented during Covid-19. Rather, the WHO and partners are claiming increased urgency, using irrelevant outbreaks such as Monkeypox to justify their haste. This is community-driven health, and post–World War II human rights, turned upside down.

A self-perpetuating funding black hole

The system proposed by the WHO will put in place a global health bureaucracy quite different from that traditionally sustained by the WHO. The organization will assess biennially each country’s readiness to respond to rare events, and demand rectification. Intensive surveillance will find the new virus variants that always evolve in nature. Rather than allowing these variants to fade away unnoticed, this bureaucracy will sequence them, name them, decide they pose a threat, and institute the society- and economy-wrecking measures they have honed since 2020. 

Although the WHO recorded just one mild ‘pandemic’ per generation for the past 100 years, this system makes the proclamation of frequent emergencies inevitable. Such ‘success’ will be essential justification to maintain funding. The response will include lockdowns and border closures, and then mass testing and vaccination “to escape these lockdowns and save the economy.” Media will sell breaking news, counting infections and available hospital beds whilst offering no context; health departments will tout essential workers as heroes at the international, regional and national level. Covid-19 established this model. 

In a country with a functioning constitutional democracy, a system based on such perverse incentives would not be allowed. But WHO does not operate under any national jurisdiction, or answer directly to any population. It does not have to endure the negative impacts of its dictates. It is prioritizing its sponsors’ needs, and seeking to impose them on distant others. If it is to take this funding, and pay its staff salaries, it has no choice.

Being realistic about health

The WHO is not the organization it was 40 years ago. Based on disease burden (what maims and kills people), the big killers of humanity apart from old age are the non-communicable diseases (i.e. most cancers, heart disease, strokes, diabetes and other metabolic disease), infectious diseases such as tuberculosis, HIV/AIDS, malaria, and the many maladies arising from childhood malnutrition. By comparison, pandemics have taken a minimal toll on humanity in the past century. Uninhibited by such realities, the WHO still considers Covid-19 (average age of death >75 years), and even monkeypox (<100 deaths globally) to be international emergencies. 

The WHO’s funding arrangements, its track record, and the perverse nature of its proposed pandemic response should be enough to render these proposed agreements anathema in democratic States. If implemented, they should make WHO unfit to receive public funding or provide health advice. The international community can benefit from coordination in health, but it would be reckless to entrust that role to an organization clearly serving other interests.

David Bell, Senior Scholar at Brownstone Institute, is a public health physician and biotech consultant in global health. He is a former medical officer and scientist at the World Health Organization (WHO), Programme Head for malaria and febrile diseases at the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland, and Director of Global Health Technologies at Intellectual Ventures Global Good Fund in Bellevue, WA

https://brownstone.org/articles/why-legislators-should-reject-whos-proposals-pandemics/