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Monday, July 4, 2022

Road injuries are killing young people, and it's hardly slowing down

 New research led by UNSW Sydney reveals traffic-related fatalities and injuries are the biggest killers of young people worldwide - causing more deaths than communicable and non-communicable diseases or self-harm. The findings are published todayin The Lancet Public Health in thefirst global analysis of transport and unintended injury-related morbidity and mortality of young people aged 10-24.

Using the latest data from the Global Burden of Disease (GBD) 2019 Study, the researchers analysed deaths and Disability-Adjusted Life Years (DALYs) from transport and unintentional injuries in adolescents across 204 countries in the past three decades. They found that despite transport injury death rates falling by a third since 1990, the number of deaths attributed to road fatalities for adolescents still increased in some countries.

"We've seen a high increase in the absolute number of injury-related deaths and DALYs, specifically in low and low-middle income countries. It indicates neglect for a growing population at risk of injury," says lead author Dr Amy Peden, research fellow with the School of Population Health at UNSW Medicine & Health.

Prevention progress stalling

According to the research, reductions in transport injury and death rates in high-income countries have slowed in the most recent decade. They dropped just 1.7 per cent a year between 2010 and 2019 compared to the fall of 2.4 per cent a year between 1990 and 2010.

"In high-income countries like Australia, there's been a real decline in progress. In the past 10 years, we've seen reductions in rates of road transport injury essentially stall, showing a lack of attention to the issue," Dr Peden says.

Adolescents are particularly vulnerable to injury risk due to increasing independence and risk-taking tendencies. However, there has been little research to date that has examined injury patterns in this vulnerable age group.

As other causes of mortality in young adults get more focus, Dr Peden says the lack of progress in reducing transport injury deaths only becomes more apparent.

"Despite being the leading cause of death in adolescents globally, it's been relatively neglected when you consider the strong action on other non-injury causes of death among adolescents," Dr Peden says.

There is also a growing burden of transport injuries in low-income countries, where the proportion of deaths almost doubled from 28 per cent in 1990 (74,713 of 271,772) to 47 per cent in 2019 (100,102 of 214,337).

Dr Peden says the shift in the burden of transport injury toward lower-income countries needs urgent assistance from the global community.

"Low socio-demographic index (SDI) countries are dealing with the challenges that come with rapid urbanisation, and as such, young people are at a greater risk of road traffic and other types of injury," Dr Peden says.

Global action on road safety

Making roads safer doesn't necessarily require radical solutions, Dr Peden says. It just needs a stronger commitment globally to promote safety behaviours.

"The prevention of road traffic injury is still not very well resourced compared to other causes of death of adolescents. So, the findings show a lack of investment in the issue from the global health community," Dr Peden says.

Graduated driver licensing, minimum drinking age laws, lower blood alcohol content levels for novice drivers, seat belt and helmet laws, and school zones have all shown to be effective in reducing injury-related harms when imposed. All-age interventions such as speed enforcement and drink driving enforcement are also effective in reducing road traffic deaths and should have increased focus, Dr Peden says.

The research also recommends promoting active transport infrastructure to prioritise alternative travel options and designing streets with the road safety needs of children and adolescents at the forefront of the planning.

"There are simple, affordable and proven interventions to reduce road traffic injuries that are not being applied or enforced," Dr Peden says. "Now is the time to step up global action on road safety and renew our efforts to safeguard adolescents from preventable injury."

The United Nations General Assembly is convening a high-level meeting on improving global road safety this month, focusing on investment in road safety.

"We have ambitious but necessary targets set out in the Decade for Action for Road Safety 2021-2030 to prevent at least 50 per cent of road traffic deaths and injuries by 2030," says Professor Rebecca Ivers, Head of UNSW School of Population Health and co-author of the paper.

"What we need now is the political will for change, backed by measurable action, financial support and the right mechanisms to implement solutions, especially in communities where the burden of road traffic injuries is greatest. This week's high-level meeting is an important step to give road safety the attention that's needed so we can save lives," Professor Ivers says.

"This entirely preventable public health issue does not occur in silos -- having safe transport systems is also directly linked to the kind of inter-sectoral action that can lead to sustainable cities and communities and to mitigate the impact of the climate crisis."

The next stage of the research will investigate the economic case for governments to invest in injury prevention interventions for adolescents and policy change worldwide, Dr Peden says.

The study was co-authored by Dr Patricia Cullen, Dr Holger Möller and Professor Rebecca Ivers from the School of Population Health and forms part of the injury workstream of the NHMRC Centre of Research Excellence: Driving Global Investment in Adolescent Health.


Story Source:

Materials provided by University of New South Wales. Original written by Ben Knight. Note: Content may be edited for style and length.


Journal Reference:

  1. Amy E Peden et al. Adolescent transport and unintentional injuries: a systematic analysis using the Global Burden of Disease Study 2019The Lancet Public Health, 2022; DOI: 10.1016/S2468-2667(22)00134-7

Twitter 'Silenced' Physicians Who Posted Truthful Information About COVID, Lawsuit Alleges

 by Megan Redshaw via The Epoch Times (emphasis ours),

Three physicians are suing Twitter, alleging the company violated its own terms of service and community standards when it suspended their accounts for posting “truthful statements regarding COVID-19 policy, diagnosis and/or treatment.”

Drs. Robert Malone, Peter McCullough and Bryan Tyson on Monday filed the lawsuit in Superior Court in California, San Francisco County.

The complaint alleges Twitter breached the terms of its contract when it permanently suspended the plaintiffs’ accounts, silenced their voices and failed to provide them with “verified” badges.

Plaintiffs allege Twitter’s actions were a substantial factor in causing them harm, and are asking the judge to order Twitter to reactivate their accounts.

All three doctors are represented by attorneys Bryan M. Garrie and Matthew P. Tyson (no relation to the plaintiff, Bryan Tyson).

Matthew Tyson on May 12, sent a letter to the directors and managing agents of Twitter requesting the company reinstate the accounts of five physicians, including the plaintiffs, and provide them with “verified” badges. Twitter failed to respond.

In the letter, Matthew Tyson acknowledged Twitter is a “private company” and its terms state it can “suspend user accounts for any or no reason.”

“However, Twitter also implemented specific community standards to limit COVID-19 misinformation on the platform, and Twitter was bound to follow those terms,” he added.

According to the complaint, Twitter’s content-moderation terms included removal procedures for ineffective treatments and false diagnostic criteria, and measures for “labeling” information as “misleading.”

Twitter has a “five-strike policy” as part of its COVID-19 misinformation guidelines and community standards.

Twitter’s website states:

The consequences for violating our COVID-19 misleading information policy depend on the severity and type of the violation and the account’s history of previous violations. In instances where accounts repeatedly violate this policy, we will use a strike system to determine if further enforcement actions should be applied.”

Strike 1 is “no account-level action.” Strike 2 results in a 12-hour account lock. Strike 3 results in another 12-hour account lock. Strike 4 results in a seven-day account lock and five or more strikes lead to permanent suspension.

Plaintiffs claim they relied on Twitter to employ and enforce its terms in good faith and it was foreseeable to Twitter that plaintiffs would rely on the terms the company is obligated to follow.

According to the complaint, a “truthful tweet regarding COVID-19 policy, diagnosis and/or treatment” would not violate Twitter’s terms of service, community standards, content moderation policies or misinformation guidelines.

“None of these physicians posted false or misleading information, nor did they receive five strikes before suspension,” Matthew Tyson stated in his letter to Twitter.

It’s no accident that Twitter violated its own COVID-19 misinformation guidelines and suspended the accounts of Drs. Zelenko, Malone, Fareed, Tyson and McCullough,” he wrote.

The letter stated:

“Twitter received express and implied threats from government officials to censor certain viewpoints and speakers, lest Twitter face the amendment or revocation of Section 230, or antitrust enforcement. This was a financial decision for Twitter.

“For the sake of profits, it chose to abandon its role as a neutral internet service provider and instead openly and intentionally collude with government to silence lawful speech.

In an email to The Defender, lead attorney Garrie and co-counsel Matthew Tyson said:

“In this political climate, honesty is a rare commodity, and concerns over new and experimental vaccines and drug therapies and the safety and effectiveness of alternative outpatient treatments should be the subject of full and transparent public debate.

“Drs. Malone, Tyson and McCullough are highly qualified and credentialed physicians and scientists who posted truthful information on Twitter that contradicted the mainstream narrative regarding COVID-19 policy, diagnosis, and treatment.

They shared fact-based information which furthered an important public interest as people around the world try to decide how to treat themselves and their loved ones for COVID-19. Twitter silenced them.

“Our clients seek to hold Twitter liable not as a Section 230 publisher, but as a counterparty to a contract, as a promisor who has breached the very terms it put in place to moderate tweets. We will hold Twitter accountable in court and prove the truth of our clients’ statements for the world to see.”

Twitter Refused to Verify Physicians’ Accounts

In addition to being suspended from Twitter, the company refused to verify the plaintiffs’ accounts even though the accounts met Twitter’s criteria for verification.

To be verified, an account must be “notable and active.”

Twitter defines a notable account to include “activists, organizers, and other influential individuals,” including “prominently recognized individuals.”

According to the complaint, Malone is an “internationally recognized scientist and physician” who completed a fellowship at Harvard Medical School as a global clinical research scholar and was scientifically trained at the University of California and Salk Institute Molecular Biology and Virology laboratories.

Malone is the “original inventor of mRNA vaccination technology, DNA vaccination and multiple non-viral DNA and RNA/mRNA platform delivery technologies,” and has “roughly 100 scientific publications, which have been cited more than 12,000 times.”

He holds an “outstanding” impact factor rating on Google Scholar and sits as a non-voting member on the National Institutes of Health [Accelerating COVID-19 Therapeutic Interventions and Vaccines] committee, which is tasked with managing clinical research for a variety of drug and antibody treatments for COVID-19.

The complaint states Malone used his Twitter account to post truthful statements regarding COVID-19 policy, diagnosis and/or treatment. He received no strikes for his content and he did not violate Twitter’s rules, yet his account was permanently suspended.

McCullough, according to the complaint, is a highly accomplished physician who is the founder and current president of the Cardiorenal Society of America.

He has been “published more than 1,000 times, made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration and the European Medicines Agency.”

McCullough has also served on the editorial boards of multiple specialty journals and was a member or chair of data safety monitoring boards of 24 randomized clinical trials.

He was a “leader in the medical response to COVID-19, has more than 30 peer-reviewed publications on the infection, and has commented and testified extensively on COVID19 treatment, including before the U.S. Senate Committee on Homeland Security and Governmental Affairs,” the lawsuit states.

McCullough’s account was suspended, but Twitter allowed him to create a new account that is followed by more than 480,000 people. Yet, he is still unable to receive a “verified” badge.

In a June 28 tweet, McCullough said “trouble is on the horizon for the “common carrier” whose only role is to provide a platform for communications operations,” referring to the lawsuit.

Tyson is a licensed physician with15 years of hospital and emergency medicine experience. He practices with Dr. George Fareed, who also was suspended from Twitter for posting what he claimed was truthful COVID-19 information.

Tyson and Fareed have “gained international recognition for providing successful early treatment to more than 10,000 COVID-19 patients, with zero patient deaths when treatment was started within 7 days,” the complaint states.

Tyson testified in various proceedings about early treatment protocols and co-authored a book about COVID-19.

He also ran as a candidate for the U.S. House of Representatives for California’s 25th Congressional District, yet was not deemed a “notable figure of public interest” regarding COVID-19 policy, diagnosis and/or treatment, which prohibited him from obtaining a “verified” badge on Twitter.

Tyson says he posted only truthful statements about COVID-19 policy, diagnosis and/or treatment with his account, and none of his tweets were classified as a “strike” or violated Twitter’s terms of service.

Like Malone’s, Tyson’s and Fareed’s accounts were permanently suspended.

“In a nutshell, these are five [physicians] of the most knowledgeable and helpful voices in the world regarding COVID-19 treatment,” Matthew Tyson wrote in his letter. “Disturbingly, Twitter silenced all of them.”

https://www.zerohedge.com/covid-19/twitter-silenced-physicians-who-posted-truthful-information-about-covid-lawsuit-alleges

Ky. AG asks state Supreme Court to reinstate abortion ban

 Kentucky Attorney General Daniel Cameron (R) asked the state’s Supreme Court on Sunday to reinstate an abortion ban that briefly went into effect following the overturning of Roe v. Wade but was later blocked by a lower court.

A judge on Thursday had temporarily blocked the implementation of two state laws, which would effectively ban abortion unless necessary to save the woman’s life, following a challenge from abortion-rights groups arguing that Kentucky’s state consitution protected abortion rights. An appeals court judge later denied a request from Cameron to reinstate the ban.

“We are exhausting every possible avenue to have Kentucky’s Human Life Protection Act and Heartbeat Law reinstated,” Cameron said in a statement. “There is no more important issue than protecting life, and we are urging the state’s highest court to consider our request for emergency relief.”

Cameron’s filings with Kentucky’s Supreme Court argue there is no right to abortion in the state’s constitution and that without an emergency ruling from it, unborn children will suffer immediate and irreparable harm.

Samuel Crankshaw — spokesman for the American Civil Liberties Union of Kentucky, which represents one of the abortion providers in the suit — praised the appeals court ruling that affirmed blocking the law’s immediate implementation.

“We’re glad to see the Court of Appeals agrees the lower court has taken proper emergency action to protect abortion access,” Crankshaw said in a statement. “This win is temporary, but we won’t back down in the fight to defend Kentuckians’ most basic rights from extremist politicians like Daniel Cameron.”

Planned Parenthood Great Northwest, Hawai’i, Indiana, Kentucky, another plaintiff in the suit, did not immediately return a request for comment.


https://thehill.com/homenews/state-watch/3545725-kentucky-attorney-general-asks-state-supreme-court-to-reinstate-abortion-ban/

Kellogg's loses UK court case over sugary cereal supermarket offers

 Kellogg's will not be allowed to promote sugary cereals in supermarket special offers, a court has ruled.

In-store promotions on food and drink high in fat, salt or sugar will be restricted under new rules for England.

Food giant Kellogg's had taken the government to court arguing the rules did not take into account the nutritional value of added milk.

But the Royal Courts of Justice ruled in favour of the government. Kellogg's said it was "disappointed".

"It makes little sense to us that consumers will be able to buy other products, like donuts and chocolate spreads, on promotion - but not many types of breakfast cereals," said Kellogg UK managing director, Chris Silcock.


The new rules were due to start in October but have been delayed by the government due to the cost of living crisis.


When they do kick in, it will mean foods deemed high in fat, sugar or salt will be banned from special offers and prime spots like checkouts, store entrances, aisle ends and their online equivalents.


Popular brands such as Crunchy Nut Corn Flakes and Fruit and Fibre are classified as high sugar in their dry form.

But Kellogg's argued including added milk would change the calculation by reducing the proportion of sugar and salt content relative to the weight of the overall serving.

The company said independent market data showed cereals were eaten with milk or yoghurt in 92% of cases.

But Judge Mr Justice Linden said Kellogg's cereals "do not come with instructions for preparation which say that they should be consumed with milk".

Mr Justice Linden said there was "no dispute" that breakfast cereals can be part of a healthy diet.

He added, however, that promoting the nutritional benefits of a particular breakfast cereal "does not affect the point that if it contains excess fat, sugar or salt, that feature of the product is adverse to a child's health".

"Nor does mixing a breakfast cereal which is high in, for example, sugar, with milk alter the fact that it is high in sugar."

His judgement said he found no unfairness to Kellogg's and the public health case for the new rules was compelling, proportionate and rational.

Kellogg's Mr Silcock said the firm would not appeal against the judgement, but urged the government to rethink the new rules.

"By restricting the placement of items in supermarkets, people face less choice and potentially higher prices," he added.


https://www.bbc.com/news/business-62034220

Eastern China cities tighten COVID curbs as new clusters emerge

 Cities in eastern China tightened COVID-19 curbs on Sunday as coronavirus clusters emerge, posing a new threat to China's economic recovery under the government's strict zero-COVID policy.


Wuxi, a manufacturing hub in the Yangtze Delta on the central coast, halted operations at many public venues located underground, including shops and supermarkets. Dine-in services in restaurants were suspended, and the government advised people to work from home.

City authorities urged residents not to leave Wuxi unless necessary, after reporting 42 new asymptomatic cases on Saturday.

China continues to try to stamp out new infections as part of the strict approach taken in the country where the coronavirus was first detected in late 2019. But the lockdowns and other measures have taken a heavy toll on the world's second-biggest economy.

Si county in Anhui province locked down its 760,000 residents and suspended public traffic as it reported 288 cases on Saturday. Anhui accounted for most of China's new infections, reporting 61 symptomatic and 231 asymptomatic cases for Saturday.

Mainland China recorded 473 new COVID-19 cases, of which 104 were symptomatic and 369 were asymptomatic, the National Health Commission said on Sunday. That compares with 268 new cases a day earlier - 72 symptomatic and 196 asymptomatic infections, which China counts separately.

Yiwu, China's export capital for small commodities, cancelled flights to the capital, Beijing, for an unspecified period, state TV said, citing COVID prevention measures. Yiwu has reported three COVID cases in the past week.

Shanghai, China's most populous city and financial hub, reported one positive case outside of quarantine areas in the city from midnight to 5 p.m. on Sunday (1600 GMT on Saturday to 0900 GMT on Sunday), officials told a news press conference.

The city lifted a lockdown on Friday after two months of shutdown that hit output and consumer spending. China's industrial production fell 2.9% in April from a year earlier.

There were no new deaths, keeping the nation's death toll to 5,226. As of Saturday, mainland China had confirmed 225,851 cases with symptoms.

For Saturday, Beijing reported no new local cases, and Shanghai reported two local symptomatic cases, according to local government data.

US FDA approval tracker: June

 It was FDA panels galore last month, with good news for most. Bluebird gained recommendations for its gene therapies eli-cel and beti-cel; full approvals will be financially crucial as these would give the group priority review vouchers to sell. FDA adcoms also recommended that Covid vaccines from Moderna and Pfizer/Biontech move into younger populations, with expanded EUAs quickly following. And Novavax finally found favour for its vaccine, although a final EUA decision could be delayed by manufacturing changes. Separately, a panel decided that an Omicron component should be included in future Covid boosters, although there were concerns about the lack of data on specific subvariants. However, it was bad news for Acadia as a panel went against its label expansion push for Nuplazid, a second setback for the antipsychotic. On approvals, Alnylam's more convenient follow-on RNAi project Amvuttra got a thumbs up in amyloidosis polyneuropathy as investors await Onpattro data in cardiomyopathy, a larger indication. Also Merck & Co's 15-valent pneumococcal vaccine Vaxneuvance is now greenlit for use in infants, a large chunk of the market. Pfizer, the leader in this space, will soon report phase 3 infant data on Prevnar 20, which covers an additional five strains.

Notable first-time US approval decisions in June
ProjectCompanyIndication(s)2028e sales by indication ($m)Outcome
Amvuttra (vutrisiran)AlnylamPolyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults2,722Approved
AXS-05AxsomeMajor depressive disorder787No decision yet, FDA did provide proposed labelling
PriorixGSKMMR vaccine371Approved
Tebipenem HBrSperoComplicated urinary tract infections including pyelonephritis181CRL (additional clinical study required)
ACER-001
(sodium phenylbutyrate)
AcerUrea cycle disorder-CRL (facility inspection)
SpesolimabBoehringer Ingelheim (private)Generalised pustular psoriasis-No decision yet
AMX0035AmylyxALS-Extended to Sep 29 (additional analyses of data)
Annik (penpulimab)Akeso/Sino3L nasopharyngeal carcinoma-No decision yet (est H1)
RyzneutaEvive Biotech (private)Chemotherapy-induced neutropenia-No decision yet
SH-111Shorla Oncology (private)Undisclosed project for T-cell leukaemia-No decision yet
Source: company releases & Evaluate Pharma.
 
Advisory committee meetings in June
ProjectCompanyIndication2028e SBI ($m)Outcome
SpikevaxModernaUpdates to EUAs for Covid-19 vaccines to include younger populations3,214Recommended (21-0) (6 mths-5 yrs)
Recommended (22-0) (6-17 yrs)
ComirnatyPfizer/
Biontech
11,605Recommended (21-0) (6 mths-4 yrs)
NuvaxovidNovavaxPrevent Covid-19 in individuals 18 years of age and older5,766Recommended (21-0, with 1 abstention)
N/AN/ADiscuss whether the Sars-CoV-2 strain composition of Covid-19 vaccines should be modified, and if so which strain should be selected for autumn 2022-Recommended inclusion of Omicron component in Covid booster vaccines
(19-2)
NuplazidAcadiaHallucinations and delusions associated with Alzheimer's disease psychosis2,181Voted against (9-3)
Elivaldogene autotemcel (Skysona, eli-cel)Bluebird bioEarly cerebral adrenoleukodystrophy (aged under 18)21Recommended  (15-0)
Betibeglogene autotemcel (Zynteglo, beti-cel)Bluebird bioBeta-thalassaemia (who require regular red blood cell transfusions)120Recommended  (13-0)
Source: FDA ad com calendar & Evaluate Pharma.

 

Supplementary and other notable approval decisions in June
ProductCompanyIndication (clinical trial)Outcome
DupixentSanofi/
Regeneron
Moderate-to-severe atopic dermatitis (6 months to 5 years) (Liberty AD Preschool)Approved
ImcivreeRhythmBardet-Biedl syndrome or Alström syndrome (NCT03746522)Approved in BBS, CRL in Alström 
BreyanziBristol2L r/r large B-cell lymphoma intended for stem cell transplant (Transform)Approved
Riabni (Rituxan biosmilar)AmgenAdults with moderate-to-severe rheumatoid arthritisApproved
OlumiantLillyAlopecia areata (Brave-AA1Brave-AA2)Approved
SkyriziAbbvieModerately-to-severe Crohn's disease in adults (AdvanceMotivateFortify)Approved
VaxneuvanceMerck & Co15 valent pneumococcal vaccine (Pneu-Ped)Approved (slightly ahead of delayed July date)
Tafinlar + MekinistNovartisTumour-agnostic indication for BRAF V600E solid tumours (RoarNCI-MATCH Subprotocol H studyStudy X2101)Approved (accelerated)
ZulressoSageInclude patients 15+ years old with postpartum depressionApproved
ReblozylBristol/
Merck & Co
Anaemia in adults with non-transfusion-dependent beta-thalassaemia (ph2 Beyond)Withdrawn (company could not appropriately address FDA questions about risk-benefit)

Maxigesic IV

Hyloris/AFT PharmaceuticalsPost-op painCRL (revise a risk assessment)
Source: company releases & Evaluate Pharma.
 
FDA Covid-19 EUAs
ProductCompanyOutcome
SpikevaxModernaInclude use of the vaccine in individuals 6 months to 17 years of age
Comirnaty



Pfizer/Biontech



Include use of the vaccine in individuals 6 months to 4 years of age

https://www.evaluate.com/vantage/articles/insights/nme-approvals-snippets/us-fda-approval-tracker-june