NICE reverses stance on Merck’s Bavencio for bladder cancer

 Last year, NICE said that Merck KGaA/Pfizer’s Bavencio was too expensive for routine in NHS use as a first-line maintenance treatment for bladder cancer, even though the drug is the only cancer immunotherapy approved for this use.

Now, the cost-effectiveness agency has relented – with the help of an additional discount from the company – clearing the way for Bavencio (avelumab) to be used in around 800 eligible people with locally advanced or metastatic urothelial carcinoma, the most common form of bladder cancer, who are progression-free following platinum-based chemotherapy.

The change in stance also followed “a successful appeal by stakeholders” that included further evidence from the pharma company of Bavencio’s efficacy in this setting, said NICE, which rejected that use in draft guidance issued in May 2021 – both for routine use and via the Cancer Drugs Fund (CDF) – saying it was not a cost-effective use of NHS resources.

From today, the PD-L1 inhibitor can be prescribed to eligible patients in England, Wales and Northern Ireland, according to Pfizer. Bavencio was approved for NHS use as a first-line maintenance therapy for bladder cancer in Scotland last August, creating unequal access to the drug across the UK.

“Clinical trial evidence showed that avelumab increases both how long people live and the length of time before their disease gets worse compared with best supportive care alone,” said NICE in a statement.

Previously, urothelial carcinoma patients were eligible only to receive supportive care until their cancer progressed, after which they could get second-line treatment with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab), chemotherapy with docetaxel or paclitaxel, or continued supportive care.

Although platinum-based chemotherapy has good initial results, most UC patients see their disease worsen within nine months of induction chemo, and only 5% of patients diagnosed with metastatic bladder cancer will live longer than five years.

The decision is based on the results of the phase 3 JAVELIN Bladder 100 study, which showed a 31% improvement in overall survival for Bavencio plus supportive care as first-line maintenance treatment following induction chemotherapy, compared to supportive care alone.

https://pharmaphorum.com/news/nice-reverses-stance-on-mercks-bavencio-for-bladder-cancer/

5 states with the highest number of COVID-19 cases

 The rate of new COVID-19 cases is at the lowest it’s been since last summer as the omicron wave subsides.

As state governments have begun to move past pandemic-era restrictions, some health experts have said that another surge is unlikely until at least the fall and winter of this year, and are hopeful new cases will continue dropping throughout the summer.

According to the Centers for Disease Control and Prevention (CDC) 95 percent of the country currently has low COVID-19 community levels.

While case rates remain low across the country, a handful of states still have elevated risk levels. Here are the five states with the highest levels of new cases per 100,000:

1) Alaska

Cases per 100,000: 26.2

Alaska currently has the highest rate of COVID-19 cases per 100,000 residents in the U.S., according to the nonprofit Covid Act Now’s real time case tracker. Its positivity test rate is also the highest among U.S. states.

However, hospitalizations in the state have remained relatively low at 4.3 per 100,000.

Roughly 62 percent of the state’s population is fully vaccinated, while a little over a quarter of residents have received a booster shot. This week, the Alaska Department of Health and Social Services began updating its COVID-19 data dashboard once a week, down from the usual three updates weekly.

2) Vermont

Cases per 100,000: 24.3

While Vermont is among the states with the highest rate of COVID-19 cases, it also among the top five states when it comes to vaccination rates. It is also among the lowest for hospitalizations, with 2.1 per 100,000.

According to the Vermont Department of Health, 81 percent of the state’s eligible population is fully vaccinated and nearly half of the more than 640,000 residents have received a booster dose.

Vermont’s COVID modeler for the past two years, Mike Pieciak, recently fully returned to his day job in the state’s Department of Financial Regulation.

“I think we we are at a place in Vermont —it really benefits from its high vaccination rate — where we can take a pragmatic approach to the future,” Pieciak told Vermont Public Radio. “When cases are low, when hospital counts are low, then society is moving forward. And really, people are demanding that they live their lives in ways that they did prior to the pandemic.”

3) Rhode Island

Cases per 100,000: 20.3

Rhode Island, like its fellow New England states, boasts a high vaccination rate — the highest in the U.S. in fact, according to COVID Act Now’s tracker. About 82 percent of the state’s population is fully vaccinated and around 43 percent is boosted.

The Ocean State’s hospitalization rate is also relatively at 4.5 per 100,000.

4) Colorado

Cases per 100,000: 18.7

While Colorado’s rate of new COVID-19 cases is higher than many other states, its hospitalization rate has remained low, two points below the U.S. average.

This past week, the Colorado Department of Public Health and Environment announced it was shutting down 40 of its 150 community COVID-19 testing sites across the state, as it transitioned to the White House’s “Test To Treat” initiative. The majority of the testing sites will close down at the end of April.

The agency’s lab director, Emily Travanty, said, “We took careful consideration of community needs and capacity demand in determining the schedule of site closures.”

5) New York

Cases per 100,000: 18.5

New York currently has a hospitalization rate of 5.8 per 100,000, making it among the top ten states in terms of hospitalizations.

While the rate of new cases has remained fairly low, a slight uptick has been observed in the past few weeks, with the seven-day average positivity rate rising by about two percentage points since mid-March. The number of new cases per 100,000 has also doubled in that same time period from about 8 to 18.

As The New York Times reported, a rise in cases in New York City is possibly being driven by the spread of the BA.2 “stealth” omicron variant. Health experts have said that the U.S. will likely see an uptick in cases due to the BA.2 strain, though a surge like those caused by the delta and omicron variants is unlikely.

https://thehill.com/policy/healthcare/3261426-the-five-states-with-the-highest-number-of-covid-19-cases/

Judge overturns Pentagon restrictions on HIV-positive service members

 A federal judge on Wednesday struck down longstanding Department of Defense (DOD) restrictions that bar HIV-positive military service members from becoming officers and deploying in active duty outside the U.S.

District Court Judge Leonie Brinkema of the Eastern District of Virginia ruled in favor of three service members in two separate cases, according to court documents shared by Buzzfeed News.

The plaintiffs in one case, under the pseudonyms Richard Roe and Victor Voe, had sued after being discharged by the Air Force in relation to a ban on overseas deployment because they were HIV-positive.

In the other, Nicholas Harrison had brought a lawsuit after his application to commission as a military lawyer with the Judge Advocate General Corps was denied.

In the former case, Brinkema ruled that the DOD cannot separate or discharge Roe and Voe or any other asymptomatic HIV-positive service member “with an undetectable viral load” because their HIV leads them to be deemed ineligible for “worldwide deployment” or to be deployed to U.S. Central Command.

She further ruled in the latter case that applications to commission as officers made by service members in the same condition cannot be denied for those reasons.

She also ordered the Secretary of the Air Force to rescind the discharge papers given to Roe and Voe and the Secretary of the Army to rescind her decision to deny Harrison’s application, ruling that both officials must reevaluate the decisions in a way that is consistent with her orders.

Wednesday’s rulings follow a 2019 directive from Brinkema in which the judge approved a preliminary injunction halting the pending discharges of Roe and Voe because they were “likely to succeed” in their legal action.

The pair filed a lawsuit in December 2018 after they received discharge papers just days before Thanksgiving. The papers said they were unfit for service because of their conditions despite the Secretary of the Air Force acknowledging they were asymptomatic, complying with treatment and had an undetectable HIV viral load.

They alleged in the lawsuit that the DOD was discriminating against them because of a long-standing policy preventing HIV-positive service members from deploying overseas without a waiver.

The Trump administration expanded on that policy when it instituted a rule declaring any service member who cannot deploy outside the U.S. for more than one year should be separated.

Current military policy puts military members who test positive for HIV into a database.

Under the Americans with Disabilities Act, which was enacted in 1990, discrimination against any person because they have HIV is illegal.

While there is no cure for HIV, the virus is treatable with medicine. Most people are able to get it under control within six months, according to the Centers for Disease Control and Prevention.

https://thehill.com/policy/defense/3262301-judge-overturns-pentagon-restrictions-on-hiv-positive-service-members/

China relies on traditional medicine to fight COVID surge in Shanghai

 Shanghai is distributing to residents millions of boxes of traditional Chinese medicine (TCM), such as herbal products and flu capsules, which it says can treat COVID-19 in the battle to control its largest virus outbreak.

China's commercial capital, now under an extended lockdown, reported more than 17,000 new COVID-19 infections on April 5, including 311 symptomatic cases, among a population of more than 26 million.

"Facing the extremely transmissible Omicron variant, we should use TCM treatment as soon as possible," said Fang Min, president of the city's Shuguang Hospital.

"For general public, including high-risk groups, taking TCM treatment when the epidemic is severe has good preventive effect," he told a news briefing on Tuesday, adding that such treatments for more than 21 million people had been handed out.

Several residents told Reuters they had received free boxes of over-the-counter flu medicine Lianhua Qingwen from neighbourhood committees in recent weeks. Others who caught COVID said they got TCM medication to be dissolved in hot water.

About 98% of Shanghai's COVID-19 patients are taking TCM treatment, and teams of TCM workers have fanned out to designated hospitals and quarantine sites since the latest outbreak began in March, Fang said.

China's health authority has recommended several TCM drugs and ingredients, such as Lianhua Qingwen, for use by COVID-19 patients, although a lack of reliable clinical data limits their use outside the country.

Singapore, which has a large ethnic Chinese population, said in November there was no scientific evidence from randomised clinical trials that any herbal product, including Lianhua Qingwen, could be used to prevent or treat COVID-19.

It advised the use of all herbal products formulated for common cold and flu only to manage symptoms such as headaches, runny or blocked noses, sore throats and coughs.

In 2020, the U.S. regulator the Food and Drugs Administration, warned vendors of Lianhua Qingwen to stop selling it as a COVID-19 treatment.

Officials in Shanghai's district of Hongkou have distributed 722,000 boxes of Lianhua Qingwen capsules, and aim to give all residents preventive TCM medicines such as herbs and tea bags, said the Shanghai Daily, which is owned by the local government.

Shijiazhuang Yiling Pharmaceutical 002603.SZ, the maker of Lianhua Qingwen, has said a 2020 clinical trial showed that it could, along with conventional therapy, relieve COVID-19 symptoms such as fever and cough.

China approved several treatments including Pfizer Inc's PFE.N Paxlovid and Brii Biosciences Ltd's 2137.HK antibody-based medicine to treat COVID patients, but it is not clear how widely they are used.

https://www.nasdaq.com/articles/china-relies-on-traditional-medicine-to-fight-covid-surge-in-shanghai

U.S. Court Reinstates Biden Federal Employee COVID Vaccine Mandate

 A U.S. appeals court panel on Thursday reinstated President Joe Biden's executive order mandating that federal civilian employees be vaccinated against COVID-19.

By a 2-1 vote, the 5th Circuit Court of Appeals lifted an injunction issued by a U.S. district judge in Texas in January that had blocked enforcement of the federal employee vaccine mandate. Biden said in September he would require about 3.5 million government workers to get vaccinated by Nov. 22, barring a religious or medical accommodation, or face discipline or firing.

The White House and Justice Department did not immediately comment.

The Biden administration argued the federal trial court had no power to hear the dispute. The administration told the appeals court that employees were required to raise their grievance through the Civil Service Reform Act (CSRA).

The panel majority said the plaintiffs "seek to circumvent the CSRA's exclusive review scheme" and that the court declined the "invitation."

Federal employee disputes generally occur before the Merit Systems Protection Board (MSPB) and then the Washington, D.C.-based Federal Circuit appeals court, the Justice Department said in its court filings.

"The injunction seriously harms the public interest by impeding efforts to reduce disruptions from COVID-19 in federal workplaces," the government's lawyers said in their court filings.

The White House has said more than 93% of federal employees have received at least one vaccination and 98% have been vaccinated or are seeking a religious or medical exemption.

In mid-January, the U.S. Supreme Court blocked Biden's COVID-19 vaccination-or-testing mandate for large businesses, a policy conservative justices deemed an improper imposition on the lives and health of many Americans. The court allowed a separate federal vaccine requirement for healthcare facilities.

A third major vaccine requirement aimed at employees of federal contractors like airlines and manufacturers was blocked by a federal judge in December.

https://www.usnews.com/news/top-news/articles/2022-04-07/u-s-court-reinstates-biden-federal-employee-covid-vaccine-mandate

Shanghai Widens COVID Testing as Other Chinese Cities Impose Curbs

 Shanghai on Friday announced a record 21,000 new cases and a third consecutive day of COVID testing as a lockdown of its 26 million people showed no sign of easing and Chinese cities tightened curbs - even in places with no recent infections.

Beijing intervened in Shanghai after the failure of its slice-and-grid approach, and insists that the country stick to its elimination approach to COVID, which it says is essential to keeping death rates low and preventing its medical system from breaking down.

Local authorities across China, which mostly managed to keep COVID at bay for the last two years, are stepping up coronavirus control measures, including movement restrictions, mass testing and new quarantine centres.

Cities that jumped into action this week included Zhengzhou, in central Henan province, which on Thursday said it would test all 12.6 million residents after finding a few asymptomatic cases in recent days.

Beijing has strengthened regular screening for employees in the city's key sectors, requiring all staff at elderly care agencies, schools and institutions handling imported goods to take tests at least once a week.

In Shizong county in southwest China's Yunnan province, shops were shut, transport suspended and residents barred from leaving their towns or villages after an asymptomatic person returned home from Shanghai and infected a household member.

Nomura this week estimated that 23 Chinese cities have implemented either full or partial lockdowns. The cities collectively are home to an estimated 193 million people and contribute 22% of China's GDP. These include Changchun, a major manufacturing hub that has been locked down for 28 days.

Ernan Cui, an analyst at Gavekal Dragonomics who studies COVID policies announced by China's 100 largest cities, said most were choosing to keep restrictions in place even after case numbers returned to zero.

"The extremely widespread Covid restrictions beyond Shanghai, and the risk-averse attitude of both central and local government officials, suggest that the economic impact of the various lockdowns will not ease in a matter of days or even weeks," she said in a note.

'THUNDEROUS' ACTION

Stories of crowded and unsanitary central quarantine centres and fears of family separation have driven calls for home quarantine in Shanghai and for China to review its "dynamic clearance" approach.

Although the government has not acceded to these requests, it has started allowing some close contacts to isolate at home and on Wednesday eased its policy of separating infected children from their parents. It is also transferring some patients to neighbouring provinces.

However, food supply remains a concern with residents, due to a shortage of couriers.

Authorities said they would allow more delivery personnel to leave locked-down areas and on Friday local media reported that platforms belonging to Alibaba and online grocer Dingdong Maicai had recalled roughly 3,500 workers altogether.

Shanghai has not indicated when it may lift its lockdown.

Late on Thursday, Wu Zunyou, chief epidemiologist at the China Center for Disease Control and Prevention, said on its Weibo account that action taken in Shanghai had to be "thunderous" to cut off the chain of transmission.

In theory, he said, if multiple rounds of PCR testing were conducted in mega-cities with populations as large as 27 million within 2-3 days, they could reach zero cases "on the community level" within 10 days to two weeks.

"As long as these measures are implemented well, our country's severe coronavirus epidemic situation will soon improve," Wu said.

https://www.usnews.com/news/world/articles/2022-04-08/shanghai-widens-covid-testing-as-other-chinese-cities-impose-curbs

China Uses AI Software to Improve Its Surveillance Capabilities

 Dozens of Chinese firms have built software that uses artificial intelligence to sort data collected on residents, amid high demand from authorities seeking to upgrade their surveillance tools, a Reuters review of government documents shows.

According to more than 50 publicly available documents examined by Reuters, dozens of entities in China have over the past four years bought such software, known as "one person, one file". The technology improves on existing software, which simply collects data but leaves it to people to organise.

“The system has the ability to learn independently and can optimize the accuracy of file creation as the amount of data increases. (Faces that are) partially blocked, masked, or wearing glasses, and low-resolution portraits can also be archived relatively accurately,” according to a tender published in July by the public security department of Henan, China’s third-largest province by population.

Henan's department of public security did not respond to requests for comment about the system and its uses.

The new software improves on Beijing's current approach to surveillance. Although China's existing systems can collect data on individuals, law enforcement and other users have been left to organise it.

Another limitation of current surveillance software is its inability to connect an individual’s personal details to a real-time location except at security checkpoints such as those in airports, according to Jeffrey Ding, a postdoctoral fellow at Stanford's Center for International Security and Cooperation.

One person, one file "is a way of sorting information that makes it easier to track individuals," said Mareike Ohlberg, a Berlin-based senior fellow at the German Marshall Fund.

China's Department of Public Security, which oversees regional police authorities, did not respond to a request for comment about one person, one file and its surveillance uses. Besides the police units, 10 bids were opened by Chinese Communist Party bodies responsible for political and legal affairs. China's Central Political and Legal Affairs Commission declined to comment.

The tenders examined by Reuters represent a fraction of such efforts by Chinese police units and Party bodies to upgrade surveillance networks by tapping into the power of big data and AI, according to three industry experts interviewed for this story.

According to government documents, some of the software's users, such as schools, wanted to monitor unfamiliar faces outside their compounds.

The majority, such as police units in southwestern Sichuan province's Ngawa prefecture, mainly populated by Tibetans, ordered it for more explicit security purposes. The Ngawa tender describes the software as being for "maintaining political security, social stability and peace among the people."

Ngawa's department of public security did not respond to requests for comment.

Beijing says its monitoring is crucial to combating crime and has been key to its efforts to fight the spread of COVID-19. Human rights activists such as Human Rights Watch say that the country is building a surveillance state that infringes on privacy and unfairly targets certain groups, such the Uyghur Muslim minority.

The Reuters review shows that local authorities across the country, including in highly populated districts of Beijing and underdeveloped provinces like Gansu, have opened at least 50 tenders in the four years since the first patent application, 32 of which were opened for bidding in 2021. Twenty-two tech companies, including Sensetime, Huawei, Megvii, Cloudwalk, Dahua, and the cloud division of Baidu, now offer such software, according to a Reuters review.

Sensetime declined to comment. Megvii, Cloudwalk, Dahua, and the cloud division of Baidu did not respond to requests for comment.

Huawei said in a statement that a partner had developed the one person, one file application in its smart city platform. The company declined to comment on the patent applications.

"Huawei does not develop or sell applications that target any specific group of people," the company said.

The documents Reuters reviewed span 22 of China's 31 main administrative divisions, and all levels of provincial government, from regional public security departments to Party offices for a single neighbourhood.

The new systems aim to make sense of the giant troves of data such entities collect, using complex algorithms and machine learning to create customised files for individuals, according to the government tenders. The files update themselves automatically as the software sorts data.

A wide range of challenges can complicate implementation, however. Bureaucracy and even cost can create a fragmented and disjointed nationwide network, three AI and surveillance experts told Reuters.

Reuters found announcements for successful bids for more than half of the 50 procurement documents analysed, with values between a few million yuan and close to 200 million yuan.

SYSTEM UPGRADE

China blanketed its cities with surveillance cameras in a 2015-2020 campaign it described as "sharp eyes" and is striving to do the same across rural areas. The development and adoption of the "one person, one file" software began around the same time.

Ohlberg, the researcher, said the earliest mention she had seen of one person, one file was from 2016, in a 200-page surveillance feasibility study by Shawan county in Xinjiang, for acquiring a computer system that could “automatically identify and investigate key persons involved in terrorism and (threatening social) stability.” A Shawan county official declined to comment.

In 2016, China's domestic security chief at the time, Meng Jianzhu, wrote in a state-run journal that big data was the key to finding crime patterns and trends. Two years later, the system was referenced in a speech to industry executives given by Li Ziqing, then-director of the Research Center for Biometrics and Security Technology of the state-run Chinese Academy of Sciences. Li also was chief scientist at AuthenMetric, a Beijing-based facial recognition company. Neither the research centre nor AuthenMetric responded to requests for comment.

"The ultimate core technology of big data’s (application to) security is one person, one file," Li said in the 2018 speech at an AI forum in Shenzhen, according to a transcript of the speech published by local media and shared on AuthenMetric’s WeChat public account.

The Party's Political and Legal Affairs Commission, which Meng led in 2016, declined to comment. Meng could not be reached for comment. Li did not respond to a request for comment.

The industry developed quickly. By 2021, Huawei, Sensetime, and 26 other Chinese tech companies had filed patent applications with the World Intellectual Property Organization for file archiving and image clustering algorithms.

A 2021 Huawei patent application for a "person database partitioning method and device" that mentioned one person, one file said that "as smart cameras become more popular in the future, the number of captured facial images in a city will grow to trillions per year”.

    SAFE CITIES

The 50 tenders Reuters analysed give varying amounts of detail on how the software would be used.

Some mentioned "one person, one file" as a single entry on a list of needed items for surveillance systems. Others gave detailed descriptions.

Nine of the tenders indicated the software would be used with facial recognition technology that could, the documents specified, identify whether a passerby was Uyghur, connecting to early warning systems for the police and creating archives of Uyghur faces.

One tender published in February 2020 by a Party organ responsible for an area in the southeastern island province of Hainan, for instance, sought a database of Uyghur and Tibetan residents to facilitate “finding the information of persons involved in terrorism.”

The Hainan authorities did not respond to a request for comment.

More than a dozen tenders mention the need to combat terrorism and “maintain stability”, a catch-all term that human rights activists say is often used to mean repressing dissent.

At least four of the tenders said the software should be able to pull information from the individual's social media accounts. Half of the tenders said the software would be used to compile and analyse personal details such as relatives, social circles, vehicle records, marriage status, and shopping habits.

https://www.usnews.com/news/world/articles/2022-04-07/china-uses-ai-software-to-improve-its-surveillance-capabilities