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Saturday, June 8, 2024

'Silicon Valley in uproar after California lawmakers demand AI firms install ‘kill switch’'

 Artificial intelligence companies are pushing back against California state lawmakers’ demand that they install a “kill switch” designed to mitigate potential dangers posed by the new technology — with some threatening to leave Silicon Valley altogether.

Scott Wiener, a Democratic state senator, introduced legislation that would force tech companies to comply with regulations fleshed out by a new government-run agency designed to prevent AI companies from allowing their products to gain “a hazardous capability” such as starting a nuclear war.

Wiener and other lawmakers want to install guardrails around “extremely large” AI systems that have the potential to spit out instructions for creating disasters — such as building chemical weapons or assisting in cyberattacks — that could cause at least $500 million in damages.

The measure, supported by some of the most renowned AI researchers, would also create a new state agency to oversee developers and provide best practices, including for still-more powerful models that don’t yet exist.

Scott Wiener, a Democratic lawmaker in the California State Senate, is proposing legislation to regulate AI.Getty Images
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The state attorney general also would be able to pursue legal actions in case of violations.

But tech firms are threatening to relocate away from California if the new legislation is enshrined into law.

The bill was passed last month by the state Senate.

A general assembly vote is scheduled for August. If it is passed, it goes to the desk of Gov. Gavin Newsom.

A spokesperson for the governor told The Post: “We typically don’t comment on pending legislation.”

A senior Silicon Valley venture capitalist told Financial Times on Friday that he has fielded complaints from tech startup founders who have mused about leaving California altogether in response to the proposed legislation.

“My advice to everyone that asks is we stay and fight,” the venture capitalist told FT. “But this will put a chill on open source and the start-up ecosystem. I do think some founders will elect to leave.”

The biggest objections from tech firms to the proposal are that it will stifle innovation by deterring software engineers from taking bold risks with their products due to fears of a hypothetical scenario that may never come to pass.

“If someone wanted to come up with regulations to stifle innovation, one could hardly do better,” Andrew Ng, an AI expert who has led projects at Google and Chinese firm Baidu, told FT.

“It creates massive liabilities for science-fiction risks, and so stokes fear in anyone daring to innovate.”

Arun Rao, lead product manager for generative AI at Meta, wrote on X last week that the bill was “unworkable” and would “end open source in [California].”

“The net tax impact by destroying the AI industry and driving companies out could be in the billions, as both companies and highly paid workers leave,” he wrote.

Prominent Silicon Valley tech researchers have expressed alarm in recent years over the rapid advancement of artificial intelligence, saying that the consequences for humans could be dire.

“I think we’re not ready, I think we don’t know what we’re doing, and I think we’re all going to die,” AI theorist Eliezer Yudkowsky, who is viewed as particularly extreme by his tech peers, said in an interview last summer.

Yudkowsky echoed concerns voiced by the likes of Elon Musk and other tech figures who advocated a six-month pause on AI research.

Musk said last year that there’s a “non-zero chance” that AI could “go Terminator” on humanity.

Worries about artificial intelligence systems outsmarting humans and running wild have intensified with the rise of a new generation of highly capable AI chatbots such as ChatGPT.

Earlier this year, European Union lawmakers gave final approval to a law that seeks to regulate AI.

The law’s early drafts focused on AI systems carrying out narrowly limited tasks, like scanning resumes and job applications.

The astonishing rise of general purpose AI models, exemplified by OpenAI’s ChatGPT, sent EU policymakers scrambling to keep up.

They added provisions for so-called generative AI models, the technology underpinning AI chatbot systems that can produce unique and seemingly lifelike responses, images and more.

Developers of general purpose AI models — from European startups to OpenAI and Google — will have to provide a detailed summary of the text, pictures, video and other data on the internet that is used to train the systems as well as follow EU copyright law.

Some AI uses are banned because they’re deemed to pose an unacceptable risk, like social scoring systems that govern how people behave, some types of predictive policing and emotion recognition systems in school and workplaces.

https://nypost.com/2024/06/07/business/california-lawmakers-demand-ai-firms-install-kill-switch/

'AbbVie's tight grip on Humira market raises concerns about biosimilars'

 AbbVie’s top-selling arthritis drug Humira has held onto more than 80% of patients after facing nine lower-priced rivals in the U.S. in the last year, raising questions about whether the market for prescription biosimilars can survive in its current form, drug pricing experts and analysts say.

Humira, which lists for almost $7,000 a month, is the first top-selling drug to compete with a slew of biosimilars, which are close but not exact copies of branded biologic medicines.

But after their launch last year, industry middlemen known as pharmacy benefit managers determined patient access with little incentive for doctors to switch to alternatives, they said.

Biosimilars were available at lower prices than Humira through the three largest benefit managers, CVS Health’s Caremark, Cigna's Express Scripts and UnitedHealth Group's Optum Rx.

At least seven drugmakers offered sharply discounted prices, but few patients used them until CVS removed AbbVie's Humira from its list of covered drugs.

Regulatory reform is needed so patients can more easily access biosimilars and draw rival drugmakers to develop them, said Stacie Dusetzina, a health policy professor at Vanderbilt University.

“It's not clear to me there's any incentive at all for companies to spend their time and money creating biosimilars. And if no one will, then the price of the brand would never come down,” she said.

The biosimilar industry is advocating for regulatory changes, saying $6 billion in potential savings have been lost since the launches.

AbbVie declined to comment, but has previously said it conceded on price to get equal access for Humira alongside biosimilars on lists of covered drugs, and expects 36% U.S. sales erosion for its drug this year. At its peak, annual sales topped $22 billion.

Unlike generic drugs, the FDA only allows some biosimilars to be swapped for the branded medicine by a pharmacist. Most must be specifically prescribed.

Last year, a bipartisan group of lawmakers backed legislation to make it easier to interchange biosimilars. The government and lawmakers have also called for reforms and are looking closely at benefit manager deals with drugmakers.

When an anticipated six biosimilars of Johnson & Johnson’s $11 billion Crohn’s disease drug Stelara hit the U.S. market starting next year, private healthcare insurers will likely repeat the Humira playbook, drug pricing experts said.

J&J Chief Financial Officer Joe Wolk told Reuters in April that the Stelara biosimilar market is likely to unfurl similarly to Humira’s given benefit manager contracting practices and doctor and patient resistance.

“Over 75% of our business comes in either Crohn's disease or ulcerative colitis, which are serious illnesses where the patients or the physicians treating them tend not to want to disrupt the therapy,” he said.

Spokespeople for Express and Optum, asked about Humira biosimilar launches, said they offered several options to give patients a choice of medicines, helping lower costs for their employer and insurer clients.

CVS Chief Medical Officer Sree Chaguturu said in an interview that the company kept covering Humira while determining which manufacturers had high-quality biosimilars with reliable supply. It now covers a Sandoz biosimilar and a co-branded Humira, both from its new Cordavis pharmaceutical unit.

WORTH THE WAIT

Benjamin Rome, a drug pricing researcher at Harvard Medical School, said that because biosimilars are not exact copies like generics, pharmacists need more information about the safety of switching medicines.

Zachary Wallace, a rheumatologist at Massachusetts General Hospital, is one of four doctors who told Reuters they had begun regularly prescribing Sandoz’s Hyrimoz biosimilar when CVS stopped covering Humira.

They said they did not want to prescribe unfamiliar biosimilars unless they were sure patients were benefiting from lower list prices.

“I would have to see that those discounts actually got passed on to patients in some way,” Wallace said.

In the U.S., drugmakers have a list price for their drugs that can be discounted for employers and insurers who receive after-market volume based discounts, called rebates.

ZS pharmaceuticals consultant Komal Gurnani predicted that as many as five Humira biosimilars will exit the market within a few years before they get to her forecast of $400 million in peak sales.

She expects companies with other planned biosimilar launches, like Amgen, Sandoz and South Korea’s Celltrion, to leverage their other products to negotiate favorable terms with insurers and stay in the market.

Sandoz and Celltrion, which have long sold Humira biosimilars outside the U.S., said they were committed to the U.S. market.

Celltrion Chief Commercial Officer Tom Nusbickel said the company is willing to wait years to gain a significant U.S. foothold. “We have a last-man standing approach to this market,” he said.

Indian drugmaker Biocon, which sells a Humira biosimilar in Europe, said it too was committed to the U.S. market, as did Pfizer, which launched its biosimilar in October.

Boehringer, which reduced its U.S. sales staff earlier this spring, Teva and Organon said they are committed to the U.S. Fresenius and Amgen declined to comment and Coherus could not be reached for comment.

Organon biosimilar head Jon Martin said it would be worth the wait even if biosimilars took six years to gain 50% market share as they did when J&J’s arthritis drug Remicade faced rivals starting in 2016.

“That's what gives us some optimism,” he said.

https://www.yahoo.com/news/abbvies-tight-grip-humira-market-100545519.html

US to research possible respiratory spread of bird flu in cows

 U.S. federal and state agencies are planning research into potential respiratory spread of bird flu among dairy cattle, according to a Reuters interview with Michigan state agriculture and public health officials.

Scientists and government officials hope the research will guide efforts to contain the virus and reduce exposure to humans. Respiratory spread could give the virus more opportunity to evolve, they said.

Scientists have so far suspected the virus spreads among animals and humans through contact with infected milk or aerosolized milk droplets, or from exposure to infected birds or poultry.

The Michigan Department of Agriculture and Rural Development is working with Michigan State University and the U.S. Department of Agriculture (USDA) to plan research on farms to evaluate respiratory spread, Tim Boring, the department's director, said in an interview.

"This is an area of concern that we're building out and looking more into," Boring said. The research is a high priority and will be important to guiding the state's public policy, he said.

A spokesperson for the USDA said the agency is researching respiratory infection in dairy cows with partners including universities across the country to better understand the virus and control its spread.

Bird flu has been reported in more than 80 dairy herds across 11 states since late March.

The exact mechanics of the spread of the virus are still unclear, though there is evidence of spread to cows from wild birds and other cows.

The virus has been identified mainly in milk, but also in nasal swabs at lesser levels, said Zelmar Rodriguez, a dairy veterinarian and assistant professor in Michigan State University's College of Veterinary Medicine who has researched affected farms.

"If it's present in the nose when the cow is shedding (virus), it's potentially transmitted through air," he said.

Any change in how the virus is transmitting gives it the opportunity to evolve, said Richard Webby, a St. Jude Children's Research Hospital virologist who studies flu in animals and birds for the World Health Organization.

"We certainly don't want that," Webby said.

But for the virus to be a more significant threat to human health, it would need to undergo further genetic mutations, Webby said.

The third dairy worker to contract avian flu, who lives in Michigan, reported respiratory symptoms, including coughing. Flu experts said the worker was most likely infected through close contact with milk through splashes or aerosolized droplets.

Respiratory symptoms have often been seen in prior human bird flu infections. The first two U.S. workers known to be infected during this outbreak only reported symptoms of conjunctivitis, or pink eye.

The U.S. Centers for Disease Control and Prevention (CDC) said the latest case does not change its assessment that bird flu is a low risk to the general public, and that it has not seen evidence of human-to-human transmission.

The worker with respiratory symptoms was still recovering as of a few days ago, said Natasha Bagdasarian, Michigan's chief medical executive, in an interview.

Michigan aims to begin its study of blood samples looking for evidence of prior bird flu infection among farm workers this month, Bagdasarian said.

Reuters reported on May 30 that the state and CDC would be conducting the study to understand the prevalence of human illness and whether any dairy workers had previously contracted the virus.

"We have folks from the CDC who are in the state right now," Bagdasarian said. "We've been working really closely and collaboratively with them, our protocols are in place

https://www.yahoo.com/news/us-research-possible-respiratory-spread-174346403.html

'WHO says bird flu case in Australia followed travel to Kolkata, India'

The World Health Organization on Friday said the child with H5N1 bird flu reported by Australia last month had traveled to Kolkata, India, and the family said they did not have any known exposure to infected people or animals while there.

The WHO said on Friday that the child, Australia's first case of H5N1 in a person, had traveled to Kolkata from Feb. 12 to Feb. 19 and returned to Australia on March 1.

The child was hospitalized on March 2 and remained there for more than two weeks. No close family contacts in Australia or India developed symptoms, as of May 22, the WHO said.

The WHO said genetic sequencing showed the virus was subtype H5N1 and part of a strain that circulates in Southeast Asia and has been detected in previous human infections and in poultry.

Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said while it would be difficult to do months after the fact, an investigation is needed to see if the child was in contact with poultry or other birds, or if there was an outbreak of this version of H5N1 nearby.

"H5N1 viruses do not transmit efficiently between humans and I suspect there’s an occult animal exposure that led to the infection," Adalja said.

https://www.yahoo.com/news/says-first-human-case-avian-190058589.html