Will the H10N3 Avian Flu Strain, Now in Humans, Become the Next Pandemic?

 The first human case of a new strain of avian flu was diagnosed in China in late May. Chinese health authorities say there is a low risk of contagion. After China notoriously underreported COVID-19 mortality, can this new assurance be trusted?

Dubbed H10N3, this strain of bird flu is a subtype of the Influenza A virus. It was diagnosed May in a 41-year-old man in Jiangsu province. The man developed symptoms April 23, was admitted to a hospital April 28, and diagnosed a month later. A few days ago, China’s National Health Authority announced he was ready to be discharged, according to coverage by The Wall Street Journal.

There was no information about how the man contracted the H10N3 virus, but the public was advised to avoid contact with sick poultry.

That advice was based on previous outbreaks of other strains of avian flu – notably Asian lineage H7N9 and HPAI Asian lineage H5N1. Those incidents occurred after close contacts with infected poultry, according to the Centers for Disease Control & Prevention (CDC). So far, however, there is no evidence of human-to-human transmission for the H10N3 strain, and the Chinese government says contact tracing efforts have not identified any other cases.

So far, so good.

Of course, China has a history of downplaying outbreaks. The SARS-CoV-2 virus that caused COVID-19 was responsible for illnesses as early as October 2019 that weren’t reported until late December 2019. Even then, the risk was minimized until other nations realized the severity of the situation.

Estimates of mortality figures in Wuhan, based on crematorium activity in January and February of 2020, for example, suggested 10-fold more deaths than normal. Early in the COVID-19 outbreak, China cracked down on scientists by requiring extra scrutiny on academic research papers relating to the cause of the pandemic before determining whether they could be published, CNN reported in April 2020. This spring, leaked documents revealed the underreporting of serious adverse conditions by China’s health authorities.

Since the beginning of the pandemic, Johns Hopkins University’s COVID-19 tracker reports that nearly 172 million people have been infected and nearly 3.7 million have died, globally, from COVID-19. It reports 103,094 cases of COVID-19 in China and 4,846 deaths from a population of 1.4 billion people, versus the 33.3 million U.S. cases and 6,723 deaths from a population of nearly 327 million.

The severe acute respiratory syndrome (SARS) outbreak that began in November 2002 in Guangdong province is another example. At the time, SARS was an unknown virus and physicians didn’t understand what was going on. Reporting was slow and the Chinese government admitted underreporting the numbers. Eventually, 8,096 people died in 26 nations.

Sometimes, of course, it’s right to merely keep an eye on things. Although the 2009 outbreak of a strain of H1N1 killed between nearly 152,700 and 575,400 worldwide, according to CDC estimates, the G4 strain of the H1N1 virus that emerged in 2020 still seems to be relatively benign despite having potentially pandemic-causing characteristics.

Hopefully, the H10N3 virus that just jumped to human will be a similarly uneventful infectious disease. After both SARS and COVID-19, however, the world is wary.

Avian influenza strains often originate in Asia and rarely spread to human populations. The H10N3 strain of the influenza virus is likely to follow that pattern. Even among birds it is rare, Filip Claes, regional laboratory coordinator for the United Nation's Emergency Center for Transboundary Animal Diseases, told Reuters.

Rarity doesn’t affect lethality, though.

A prior strain of H5N1 first was detected in geese in 1996 before jumping to humans in 1997. Only about 700 human cases have been reported since that jump. Those cases, however, had a 60% mortality rate. Mortality was highest among people between the ages of 10 and 19, the CDC reported, most likely because older adults still had immunity from a related virus that swept the U.S. decades earlier.

Unless the H10N3 virus becomes easily transmissible among humans, it doesn’t pose a significant health threat to the world’s human population. As Adolfo Garcia-Sastre, a professor at the department of microbiology at Icahn School of Medicine at Mount Sinai in New York told the Wall Street Journal, “It is highly likely that this infection just represents one of the rare incidents of human infection with an avian influenza virus, without any more consequences.”

https://www.biospace.com/article/will-the-h10n3-avian-flu-strain-now-in-humans-become-the-next-pandemic-/

Will Insurers Pay for New Alzheimer's Drug?

 Biogen's Alzheimer's drug aducanumab (Aduhelm) may have been cleared by the FDA, but its uptake will be influenced by insurance coverage, particularly by Medicare.

The $56,000 annual price tag on the therapy is far higher than the $8,300 estimated by the Institute for Clinical Economic Review (ICER) to be cost-effective, setting the stage for potential insurance challenges.

"Only a hypothetical drug that halts dementia entirely would merit this pricing level," ICER said in a statement. "The evidence on aducanumab suggests that, at best, the drug is not nearly this effective."

ICER noted that the FDA label for the drug extends beyond the study population of patients with mild cognitive impairment and mild dementia to all patients with Alzheimer's, making nearly 6 million people in the U.S. eligible for the therapy. Biogen estimated in a press release that 1 to 2 million people in the U.S. who have mild cognitive impairment or mild dementia would likely have amyloid beta pathology if tested.

ICER noted that "even at the lower range of the estimated number of eligible patients, at this price the drug maker would stand to receive well in excess of $50 billion per year even while waiting for evidence to confirm that patients receive actual benefits from treatment."

It could take a while before that confirmation is available: Biogen's CEO Michael Vounatsos told CNBC the company has up to 9 years to complete the trial.

In the meantime, insurers will weigh the value of the drug, as well as the accompanying scans, infusions, and other procedures, in any coverage decisions. The drug's label, for instance, recommends obtaining an MRI prior to initiating treatment, and obtaining MRIs "prior to the 7th and 12th infusions" to assess risk of ARIA-H, or cerebral microhemorrhages.

All eyes are on CMS given that a significant proportion of Alzheimer's patients are covered under Medicare. The agency could launch a National Coverage Determination (NCD) process for aducanumab, according to a Health Affairs article by Sean Dickson, JD, MPH, of West Health Policy Center, a think tank focused on lowering healthcare costs, and colleagues.

NCDs are "the most powerful coverage tool Medicare has," Dickson and colleagues wrote, and they're generally reserved for costly treatments, services that have variable local coverage decisions, or when there's scientific dispute about efficacy in beneficiaries. Aducanumab meets all three of those criteria, the paper argued.

Medicare also has the option of issuing a "Coverage with Evidence Development" decision that would cover those enrolled in a clinical trial aimed at collecting more data, as was the case for amyloid PET imaging.

A CMS spokesperson said in an email to MedPage Today that the agency is "reviewing the FDA's decision regarding aducanumab and will have more information soon."

As for commercial insurers, Biogen and partner Eisai said in a press release they "intend to enter into a value-based contract" with Cigna "to ensure that there is a streamlined path to access treatment for patients consistent with the population in which Aduhelm was studied."

Cigna's chief clinical officer Steve Miller, MD, told the Wall Street Journal that the company will likely cover the drug for those who match the profile of clinical trial participants, but noted that additional out-of-pocket testing costs "could be a real barrier for those patients who lack the financial means."

Biogen already has patient support available, which helps eligible patients access financial assistance options. In its press release, the company stated that "co-pay and infusion cost assistance programs may reduce out-of-pocket costs to as low as $0" for commercially insured patients.

MedPage Today reached out to several commercial insurers -- including UnitedHealthcare, Cigna, Aetna, and Anthem -- but only Humana responded: "As we develop our coverage policy at Humana, we will look to the Centers for Medicare and Medicaid Services for guidance to ensure that there is consistent access to this therapy in the Medicare program for patients and their families," referring to the insurer's Medicare Advantage plans.

As for its commercial plans, the spokesperson said the company's "Pharmacy and Therapeutics Committee will evaluate coverage of Aduhelm."

https://www.medpagetoday.com/special-reports/exclusives/92990

SPAC Foresight Acquisition II files for $250 million IPO, led by former CEO of Walgreens

 Foresight Acquisition II, a blank check company targeting tech-enabled consumer and consumer healthcare businesses, filed on Tuesday with the SEC to raise up to $250 million.

The Chicago, IL-based company plans to raise $250 million by offering 25 million units at $10. Each unit consists of one share of common stock and one-third of a warrant, exercisable at $11.50. At the proposed deal size, Foresight Acquisition II would command a market value of $320 million.

The company is led by Chairman Greg Wasson, the former CEO of Walgreens, where he served prior to founding his family investment office Wasson Enterprise. He is joined by CEO and Director Michael Balkin, who was previously a Partner and Co-Manager of the William Blair Small Institutional Portfolio and the William Blair Small Cap Growth Fund, and CFO Gerald Muizelaar, who has served as VP of Finance for Wasson Enterprise since 2017. Management's previous SPAC, Foresight Acquisition (FORE; -1% from $10 offer price), went public this past February and has a pending merger agreement with healthcare services provider P3 Health Partners.

Foresight Acquisition II intends to capitalize on the track record and experience of management and target the technology-enabled consumer and consumer healthcare industries, focusing on businesses with enterprise values greater than $1 billion.

Foresight Acquisition II was founded in 2021 and plans to list on the Nasdaq under the symbol FACQU. Cowen and William Blair are the joint bookrunners on the deal.

Relevant Profile: FACQU

https://www.renaissancecapital.com/IPO-Center/News/82497/SPAC-Foresight-Acquisition-II-files-for-a-$250-million-IPO-led-by-the-forme

Ohio sues Google, claims tech giant should be regulated as public utility

 The state of Ohio filed suit against Google on Tuesday, claiming the tech giant should be regulated as a public utility due to its "discriminatory and anti-competitive" practices.

The civil action, filed by Ohio Attorney General Dave Yost in Delaware County Common Pleas Court, does not seek monetary damages, but instead asks for Google to be declared a "common carrier" that could come under oversight from a body such as the state's Public Utilities Commission.

“Google uses its dominance of internet search to steer Ohioans to Google’s own products — that's discriminatory and anti-competitive,” Yost said in a prepared statement.

“When you own the railroad or the electric company or the cellphone tower, you have to treat everyone the same and give everybody access."

In the civil complaint, Yost said he's concerned about Google's ability to create "no click searches," which means a query that directs users "to other Google platforms, such as YouTube, Google Flights, Google Maps, Google News, Google Shopping and Google Travel."

Google "has a duty not to artificially prioritize Google services and links higher than they would be displayed as a result of Google's internet searches algorithms in which the algorithm is not programmed to prioritize Google's owed products and services," the suit said.

A representative for Mountain View, California-based Google said the lawsuit will not succeed.

“Google Search is designed to provide people with the most relevant and helpful results," according to a company statement.

"AG Yost's lawsuit would make Google Search results worse and make it harder for small businesses to connect directly with customers. Ohioans simply don't want the government to run Google like a gas or electric company. This lawsuit has no basis in fact or law and we'll defend ourselves against it in court.”

MSNBC legal analyst Danny Cevallos said Ohio's end game isn't to put Google under the direct authority of a utilities commission, but to lay the groundwork for increased regulation.

He cited services such as cable TV, trash hauling, airlines and casinos that are provided by private companies, but are almost always subject to rules and regulations above and beyond other businesses.

"When a business serves such a substantial part of the public that its rates, charges and methods of operation become a public concern, it can be characterized as a public utility" and targeted for increased government oversight, Cevallos said.

https://www.nbcnews.com/news/us-news/ohio-sues-google-claims-tech-giant-should-be-regulated-public-n1269986

At J&J, Some 15.5 Billion Potential Cyberattacks Each Day

 Covid-19 vaccines have transformed the global economy. The companies that produce them, meanwhile, already a big target for hackers, have to be more on their toes than ever.

Marene Allison, chief information security officer at Johnson & Johnson, oversees the company's efforts to protect its operations from cybercrime. Ms. Allison spoke about the challenges J&J faces with Daniela Hernandez, a reporter for The Wall Street Journal, as part of the WSJ Pro Cybersecurity Executive Forum. Edited excerpts of their online interview follow.

WSJ: Can you give us a sense of how often cyberattacks have been happening in your experience at J&J?

MS. ALLISON: We're seeing what I would consider 15.5 billion incidents a day. Now how many of them become attacks and get investigated is a much lower number.

Some are as simple as malware that is just knocked out of the system. We have big data sets. We're bringing in logs and detections from around the world continually. And then we're looking at it with machine learning and AI, as well as other alerts, to know if we have a problem or not. It could be as simple as a log on a server giving an alert that says something is happening. It may be nothing.

WSJ: Can you talk more about the sources of the threats?

MS. ALLISON: I bracket them into four main threats. The first one is on the top of the news: nation-state attacks. Looking at the countries that are primarily in this field, it's China, Russia, North Korea and Iran, but many, many others.

Then you have something called a criminal element that over the last 10 years has increased from very small to very large. What we see with ransomware today, that's mostly criminal enterprise. They may be allowed by some countries to operate in those countries, but it's a criminal enterprise.

Then you have hacktivists: people with a cause, on a mission. They don't like something a company does, or don't like the stand of a company. They will go ahead and start campaigns that companies have to deal with.

And the other is insiders. Everything from a disgruntled employee, someone who may have gotten notice; but some countries are actually sending people over, through educational visas, to get jobs or to work on special programs, so they actually can steal the data from inside.

WSJ: How do you tackle each individual threat?

MS. ALLISON: For the nation states, the criminal and the hacktivist, you're pretty much going to use your normal toolset: the ability to detect malware, spearphishing, code that's inside your company moving laterally. Also working with third parties from the outside.

For the insider threat, you may have to work with your global security organization, your legal department, your HR organizations and others on policies and procedures, as well as potentially privacy rules, in different jurisdictions around the globe.

WSJ: When it comes to the vaccine, which is important for the economy, how often do you communicate with the government on potential cyber threats to that kind of information, development information?

MS ALLISON: Under Operation Warp Speed, we did work very closely with the government. And we were able to have communications, work with Health and Human Services and the Food and Drug Administration, very, very closely. My very first call when I found out that we were doing the vaccine was to Chris Krebs, [then-]director of the Department of Homeland Security's Cybersecurity and Infrastructure Security Agency, to start the conversation.

The other conversations were with my peers that were also creating the vaccine. I think almost weekly, biweekly, we'd have conversations and meetings with the security element of what was then called Operation Warp Speed -- not only cyber but also physical, conversations about what was happening so that people would know if people had stolen vaccines, and not just J&J, but the whole community.

https://www.marketscreener.com/quote/stock/JOHNSON-JOHNSON-4832/news/At-J-J-Some-15-5-Billion-Potential-Cyberattacks-Each-Day-Journal-Report-35551630/

QIAGEN NV: Goldman Sachs gives a Buy rating

 Analyst Matthew Sykes from Goldman Sachs research considers the stock attractive and recommends it with a Buy rating.

https://www.marketscreener.com/quote/stock/QIAGEN-N-V-40135659/news/QIAGEN-NV-nbsp-Goldman-Sachs-gives-a-Buy-rating-35550632/

SANOFI: Receives a Buy rating from Credit Suisse

 Analyst Dominic Lunn from Credit Suisse research considers the stock attractive and recommends it with a Buy rating. The target price is unchanged at EUR 96.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/SANOFI-nbsp-Receives-a-Buy-rating-from-Credit-Suisse-35550326/