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F.D.A. Approves A.L.S. Treatment Despite Questions About Effectiveness

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F.D.A. Approves A.L.S. Treatment Despite Questions About Effectiveness

The Meals and Drug Administration on Thursday authorised an experimental remedy for A.L.S., a extreme neurological dysfunction that causes paralysis and demise, regardless of questions concerning the remedy’s effectiveness.

The remedy, conceived a few decade in the past by two faculty college students, was authorised despite the fact that analyses by the F.D.A.’s reviewers concluded there was not but ample proof that the treatment may assist sufferers reside longer or sluggish the speed at which they lose features like muscle management, talking or respiratory with out help. Nonetheless, the company determined to greenlight the drug with out ready two years for outcomes of a big medical trial, citing knowledge exhibiting the remedy to be secure and the desperation of sufferers with a illness that always causes demise inside two-to-five years.

The drug, which has the scientific identify AMX0035, will probably be marketed as Relyvrio.

In a abstract memorandum concerning the drug the F.D.A. wrote that there was “residual uncertainty concerning the proof of effectiveness,” however that “given the intense and life-threatening nature of A.L.S. and the substantial unmet want, this stage of uncertainty is appropriate on this occasion.” The memorandum additionally mentioned that the advantages outweigh the dangers as a result of the remedy is “with none vital security alerts of concern.”

The approval follows an impassioned marketing campaign by sufferers and advocacy teams. As well as, medical doctors who deal with A.L.S. sufferers had urged approval in a letter to the F.D.A. and testimony and in testimony earlier than an F.D.A. advisory committee.

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“In your tough job, there’s at all times going to be an opportunity of creating a mistake; it comes right down to which mistake you’d somewhat make,” Dr. Richard Bedlack, director of the A.L.S. clinic at Duke College, testified this month. “To approve AMX0035 and discover out in two years that it doesn’t work — I doubt many are going to be very offended as a result of individuals with A.L.S. bought to attempt one thing that was secure and appeared promising in 2022.”

However, he added, “Are you able to think about the error of claiming no after which getting confirmatory proof in two years that this actually did work? And realizing all these sufferers have been way more disabled and even useless once they didn’t should be? I don’t know the way you’ll be capable of reside with your self for those who make that mistake.”

A.L.S., or amyotrophic lateral sclerosis, additionally known as Lou Gehrig’s illness, is recognized in about 6,000 individuals worldwide every year. There are solely two different authorised A.L.S. drugs in the USA: riluzole, authorised in 1995, which might lengthen survival by a number of months, and edaravone, authorised in 2017, which might sluggish development by about 33 p.c.

Relyvrio was conceived by Justin Klee and Joshua Cohen once they have been undergraduate college students at Brown College. They proposed that combining taurursodiol, a complement typically used to control liver enzymes, and sodium phenylbutyrate, a medicine for a pediatric urea dysfunction, may shield neurons within the mind from harm in ailments like A.L.S. by stopping dysfunction of two buildings in cells: mitochondria and the endoplasmic reticulum. They later based a small Massachusetts firm, Amylyx Prescription drugs.

As sufferers realized concerning the compound, some started acquiring the components on their very own from Amazon and different sources. In June, Canada grew to become the primary nation to approve the remedy, underneath a particular situation requiring Amylyx to later present higher proof that it labored. Advocacy teams predicted that some American sufferers would search it from Canada, the place it’s marketed as Albrioza, if the F.D.A. didn’t approve it.

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Amylyx didn’t instantly say what worth it’s contemplating for the remedy in the USA and has mentioned the worth continues to be being negotiated in Canada.

 “Amylyx’s aim is that each one who is eligible for Relyvrio could have entry as shortly and effectively as potential as we all know individuals with A.L.S. and their households haven’t any time to attend,” the corporate mentioned in a press release after the F.D.A. announcement.

The treatment, a bitter-tasting powder blended with water and both drunk or ingested via a feeding tube, traveled an uncommon and controversial path to approval. The F.D.A. sometimes requires two persuasive medical trials, often Section 3 trials, that are bigger and extra intensive than Section 2 research. For critical ailments with few remedies, the company can settle for one trial plus extra confirmatory knowledge.

For Relyvrio, the information comes solely from one Section 2 trial by which 137 sufferers took both the drug or a placebo, plus an extension examine that adopted some sufferers after the trial ended once they have been knowingly taking the drug.

The Section 2 trial concerned sufferers thought-about to have fast-progressing illness. Two-thirds of contributors acquired Relyvrio. Over 24 weeks, they skilled a 25 p.c slower decline than contributors receiving placebo — declining 2.32 factors much less on a 48-point A.L.S. scale that charges 12 bodily talents, together with strolling, talking, swallowing, dressing, handwriting and respiratory.

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The open-label extension examine concerned 90 of these sufferers, together with 34 from the placebo group, who started taking the treatment about seven months after those that acquired it from the start. Sufferers who acquired the remedy the longest had a median of about 6.5 months extra time earlier than being hospitalized, being placed on a ventilator or dying, Amylyx reported. Researchers later printed one other evaluation that instructed extra profit.

The F.D.A. initially really useful that Amylyx not apply for approval till the Section 3 trial was accomplished in 2024.

A.L.S. advocacy teams campaigned vehemently to steer the F.D.A. to rethink, particularly after the company’s controversial approval final 12 months of the Alzheimer’s drug Aduhelm regardless of doubts about whether or not it labored. Quickly after, F.D.A. officers started suggesting that Amylyx submit an utility for approval utilizing present knowledge.

In March, a committee of impartial advisers to the F.D.A. voted by a slim margin that the remedy had not but been proven to be efficient, a conclusion additionally reached by the F.D.A.’s personal reviewers. The company then allowed Amylyx to submit extra knowledge and took the weird step of scheduling a second impartial advisory committee assembly on Sept. 7. In a report offered there, company reviewers mentioned additionally they thought-about the brand new knowledge inadequate.

However Dr. Billy Dunn, director of the F.D.A.’s workplace of neuroscience, advised the advisory committee that “though some would possibly moderately argue that substantial proof doesn’t presently exist” to justify approval, the company ought to train “the broadest flexibility” by additionally contemplating the seriousness of the illness and the dearth of obtainable remedies.

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Dr. Dunn posed a query to the corporate: If the remedy acquired approval now and was proven to be ineffective within the Section 3 trial, would Amylyx voluntarily withdraw it from the market, saving the company a prolonged recall course of? Mr. Klee mentioned the corporate would.

That dedication by Amylyx, plus emotional testimony from sufferers and medical doctors, persuaded extra advisory committee members on the September assembly, the place the vote favoring approval was seven to 2.

A kind of who voted in opposition to approval, Dr. Kenneth Fischbeck, a distinguished investigator for the Nationwide Institutes of Well being, mentioned the corporate may present the remedy to sufferers totally free whereas ready for higher proof, however “I don’t assume it’s met the usual of proof to permit them to promote the drug.”

Mark Weston, a member of the advisory committee who has A.L.S., mentioned he was upset that the brand new data the corporate offered wasn’t stronger. “I hoped for one thing extra,” he mentioned. However Mr. Weston, who earlier within the assembly named A.L.S. sufferers who had died for the reason that March listening to, mentioned he voted for approval as a result of “I can’t decouple my ideas about that from my ideas concerning the unmet want.”

That want for remedies was the overwhelming message of sufferers who testified. “As an alternative of pondering you might be defending me I would like you to advocate approval in order that I’ve the possibility to reside,” mentioned Brian Wallach, 41, who co-founded “I AM ALS,” an advocacy group, in testimony largely learn by a pal as a result of A.L.S. has profoundly broken his capability to talk.

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Gregory Canter, one of many medical trial contributors, mentioned “the speed of my purposeful decline has slowed significantly” since starting the drug over three years in the past.

“A.L.S. is the basement; this begins us up the steps,” Mr. Canter mentioned. “It received’t get us to the highest alone, however every step up is necessary to level us in the best course.”

Calaneet Balas, president and chief govt of the A.L.S. Affiliation, mentioned in a press release that the F.D.A. resolution was “a victory for all the ALS neighborhood, which got here collectively to advocate for early approval of AMX0035.” The affiliation and different advocacy teams met with F.D.A. officers, submitted a petition with over 50,000 signatures and arranged a marketing campaign producing over 13,000 emails to the company.

The A.L.S. Affiliation contributed $2.2 million to the event and examine of AMX0035, utilizing cash raised via the 2014 Ice Bucket Problem. Amylyx agreed to make use of gross sales of the drug to repay 150 p.c of the affiliation’s grant to fund extra analysis.

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Column: With its 'Chevron' ruling, the Supreme Court claims to be smarter than scientific experts

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Column: With its 'Chevron' ruling, the Supreme Court claims to be smarter than scientific experts

Second only to the Supreme Court’s ruling Monday on when presidents are immune from criminal prosecution, the biggest case of the court’s recently completed session involved the age-old conflict between judges and government regulators.

The case concerned a 40-year-old precedent known as “Chevron deference.” That doctrine held that when a federal law is ambiguous, the courts must defer to the interpretations offered by the agencies the law covers — as long as those interpretations are “reasonable.” On Monday, the court discarded Chevron deference.

This may sound like an abstruse legalistic squabble, but it has massive implications for Americans in all walks of life. It could subject agency decisions on scientifically based issues such as clean air and water regulations and healthcare standards to endless nitpicking by a federal judiciary that already has displayed an alarming willingness to dismiss scientific expertise out of hand, in favor of partisan or religious ideologies.

In one fell swoop, the majority today gives itself exclusive power over every open issue—no matter how expertise-driven or policy-laden.

— Supreme Court Justice Elena Kagan

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The ruling amounts to an apogee of arrogance on the part of the Supreme Court’s conservative majority, wrote Justice Elena Kagan in a dissent joined by Justices Sonia Sotomayor and Ketanji Brown Jackson. But it’s not a new development.

“The Court has substituted its own judgment on workplace health for that of the Occupational Safety and Health Administration,” Kagan wrote; “its own judgment on climate change for that of the Environmental Protection Agency; and its own judgment on student loans for that of the Department of Education…. In one fell swoop, the majority today gives itself exclusive power over every open issue — no matter how expertise-driven or policy-laden.”

Chevron deference originated in 1984, when environmentalists were fighting an effort by the EPA under Ronald Reagan to loosen clean air rules at the behest of industrial polluters. As it happens, the environmentalists lost that battle, but over time they won the war against deregulation.

Conservatives have had it in for Chevron deference for a long time; given their current majority on the court, the doctrine’s death has been a foregone conclusion, awaiting only the appearance of a suitable case to use as a bludgeon. Indeed, the majority was so impatient to kill the doctrine that the court’s six conservatives chose to do so by using a case that actually is moot.

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That case arose from a lawsuit brought by the herring industry, which objected to a government policy requiring herring boats to pay for government observers placed on board to make sure the boats were complying with their harvesting permits.

The rule was imposed under the Trump administration, but it was canceled in April 2023 by Biden, who repaid the money that had been taken from the boat owners — so there’s nothing left in it for the court to rule on.

Interestingly, Chevron deference was not always seen as a bulwark protecting progressive regulatory policies from right-wing judges, as it’s viewed today. At its inception, it was seen in exactly the opposite way — as giving conservative policies protection from progressive-minded judges.

The Natural Resources Defense Council, which brought the original case in an effort to preserve Clean Air Act regulations that were being overturned by the Reagan administration, counted the 1984 ruling as a severe loss.

At issue then was the definition of a pollution “source.” Past practice defined it as a single building or smokestack; the administration wanted to redefine “source” broadly, as referring to an entire pollution-emitting plant. This wasn’t a trivial difference. The NRDC’s interpretation was more stringent than the government’s, for the latter allowed a polluter essentially to hide law-breaking emissions within an otherwise non-polluting plant.

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The original Chevron ruling was 6 to 0 (three justices didn’t participate — two because of illness and the third, Sandra Day O’Connor, recused herself because of a conflict of interest). The ruling stated that when a federal law was ambiguous or silent on a particular issue, judges were bound to defer to the interpretation offered by the agency covered by the law, as long as its interpretation was “reasonable.”

One other thing: The functionary pushing to give industry more freedom to pollute was Reagan’s Environmental Protection Agency administrator, the late Anne Gorsuch. Name sound familiar? Justice Neil M. Gorsuch, who is her son, lined up with the anti-Chevron majority. Curiously, he didn’t mention his family history in his separate concurrence — or perhaps not so curiously, because his mother was on the winning side of the decision that he has now voted to overturn.

In any event, Gorsuch’s words about the case in which his mother triumphed were telling. “Today,” he concluded gleefully, “the Court places a tombstone on Chevron no one can miss.”

The truth is that the Chevron ruling of 1984 and Monday’s ruling both served a goal shared by Anne Gorsuch and her offspring: providing federal judges all the leeway they might need to see things the way Big Business prefers.

Forty years ago, when the Reagan White House was pulling down a regulatory edifice that industry resented, the Supreme Court was happy to have judges defer to the agencies participating in that project, including Anne Gorsuch’s EPA. Today, when the deregulatory process is opposed by government agencies that take seriously their duty to make life better for the average consumer, the court tells judges that they’re free to ignore agency findings.

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In his majority opinion, Chief Justice John G. Roberts Jr. called Chevron “misguided because agencies have no special competence in resolving statutory ambiguities. Courts do.”

This is self-refuting. Chevron deference isn’t about “resolving ambiguities” in the law. It’s about recognizing that sometimes those ambiguities are deliberate — put in place by lawmakers who know they can’t possibly write a law that covers all situations from now to the end of time. The “ambiguities” are there because Congress wishes that the agencies it has charged with fulfilling its goals use their technical and scientific knowledge to meet the challenges of a changing world.

Things have indeed changed. Generally speaking, wrote legal scholar Cass R. Sunstein in 2019, environmentalists and other progressives saw the original decision as “a capitulation to the (insufficiently zealous) administrative state, which was often captured by powerful private interests.” Today, the right wing portrays the “administrative state” as a shadowy cabal bent on thwarting the will of the people (that is, conservative policies). “The right and the left have switched sides,” Sunstein observed.

Chevron deference was very much a product of its time, Sunstein noted. In the 1960s and 1970s, “federal courts had been aggressively reviewing agency action (and inaction), often with the goal of producing greater regulation.” Typically, “the judges were on the political left.”

They had grown up professionally in the atmosphere created by the Warren court, which fostered the notion that the courts existed to protect and extend individual rights. “To their defenders,” Sunstein wrote, “the lower federal courts assumed a kind of heroic stance.”

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This was the era that brought us an unprecedented, judicially driven expansion of individual rights, through such decisions as Griswold vs. Connecticut (1965), which established the right of married couples to use contraceptives without state interference; Loving vs. Virginia (1967), which invalidated laws against interracial marriage; and of course Roe vs. Wade (1973), which established the nationwide right to abortion.

The current conservative majority has already begun to roll back this historic approach to individual rights, most notably through the Dobbs decision of 2022, which overturned Roe vs. Wade.

Justice Clarence Thomas has suggested that Griswold should follow Roe vs. Wade into the juridical dumpster, along with Lawrence vs. Hodges (2003), which invalidated state laws against sodomy among consenting adults, and Obergefell vs. Hodges (2005), which legalized same-sex marriages nationwide. The court, Thomas remarked in his concurring opinion in Dobbs, “should reconsider” those rulings.

Those cases were decided on different grounds from Chevron, but liberal judges saw the expansion of individual rights as part of the same principle that prompted them to aggressively examine agency actions that tended to narrow those rights.

As it happens, the Chevron decision didn’t generate much interest when it was handed down. The six justices who ruled unanimously in the EPA’s favor apparently thought they were weighing in on a narrow technicality. One legal scholar has called Chevron an “accidental landmark”; its significance only emerged from subsequent federal rulings and, perhaps most important, its embrace by Justice Antonin Scalia, who joined the Supreme Court two years later.

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Scalia wrote in a 1989 law review article that Chevron deference made sense in the modern world: If there was an ambiguity in the law, the reason was either that Congress was sloppy (in which case the courts had the duty to say what a law meant) or that the lawmakers deliberately delegated to agencies the task of responding to changing realities by using their “advancing knowledge.” Over time, to be sure, he grew discontented with the doctrine (as Roberts and Gorsuch took pains to point out.)

Monday’s decision puts the lie to conservatives’ oft-expressed disdain for policies made by “unelected” bureaucrats. “Agencies report to a President, who in turn answers to the public for his policy calls; courts have no such accountability,” Kagan wrote. Calling the decision “a bald assertion of judicial authority, she added: “The majority disdains restraint, and grasps for power.”

That’s not to say that the majority won’t share the power they have now arrogated for themselves. They will walk hand-in-hand with the Big Business leaders and conservative ideologues who put them on the court, and the rest of us will just have to live with the consequences.

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L.A. fast-food workers may get a helping hand from City Council

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L.A. fast-food workers may get a helping hand from City Council

Fast-food workers have long complained of unstable schedules that make it difficult to plan their finances, child care, medical appointments and other obligations.

Now, a proposal by Los Angeles City Councilmember Hugo Soto-Martinez aims to give these workers more stability and consistency in scheduling, as well as access to paid time off.

The proposal, which Soto-Martinez plans to introduce Tuesday, aims to expand the reach of the city’s Fair Work Week law — which requires that employers give retail workers their schedules in advance — to include some 2,500 large chain fast-food restaurants that employ roughly 50,000 workers.

It also proposes an annual mandatory six-hour paid training period to help educate workers on their rights. And it would require that fast-food workers accrue an hour of paid time off for every 30 hours they work — on top of paid sick leave to which they are already entitled.

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The push is the latest move by lawmakers across the state to improve working conditions for low-wage fast food workers who’ve struggled to make ends meet in expensive cities such as Los Angeles. Earlier this year, California adopted a minimum wage for fast-food workers of $20 an hour.

But the proposed city ordinance is likely to be met with stiff opposition from industry groups.

Several business and trade groups have said that this type of predictable scheduling policy complicates the process of scheduling staff.

The Los Angeles Area Chamber of Commerce had said that a similar L.A. County measure would hamper businesses already struggling to compete against e-commerce companies. And the California Grocers Assn. said it would make last-minute staffing changes “extremely challenging.”

Soto-Martinez said the idea behind the L.A. measure is to give fast-food workers the ability to attend a wedding, a quinceañera, a doctor’s appointment, or their child’s graduation — entitlements of many white-collar workers.

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“Fast-food workers, their needs and their desires, are often irgnored. We need to do our part as a city,” he said.

The proposal is backed by California’s statewide union of fast-food workers, formed earlier this year. The California Fast Food Workers Union, created with help from the Service Employees International Union, is the culmination of years of employee walkouts over issues including the handling of sexual harassment claims, wage theft, safety and pay, such as the Fight for $15 movement to increase the minimum wage, which was organized by the SEIU in 2012.

“The 50,000 of us who stand to gain important protections on the job through this ordinance are not just fast-food workers, we are parents, grandparents, students and providers,” Anneisha Williams said in a statement by the union.

Williams, who works at a Los Angeles Jack in the Box, is a member of the state’s newly formed Fast Food Council.

Julieta Garcia, 36, who has worked at a Pizza Hut in Historic Filipinotown for 1½ years, said her hours are very irregular, averaging about 20 hours a week.

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“Mentally, it has hurt me — the stress of figuring out how I will cover all of my bills,” she said.

Garcia said it has also made it difficult to show up for her family. Paid time off would help her be able to attend her son’s school plays, or visit a terminally ill family member, she said.

L.A. is among several cities nationwide, including Seattle, New York and Chicago, that have adopted scheduling laws.

L.A.’s Fair Work Week law, approved by Los Angeles City Council in 2022, already requires large retail and grocery chains such as Target, Ralphs and Home Depot to give employees their work schedule at least two weeks in advance. It further requires businesses to give workers at least 10 hours’ rest between shifts, or provide extra pay for that work.

Researchers at the Shift Project, an initiative from Harvard University and UC San Francisco that is focused on service-sector workers, have found that upredictable work schedules lead to unstable incomes as well as poor sleep and psychological distress.

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Apple announces deal with OpenAI. Will it be a game-changer?

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Apple announces deal with OpenAI. Will it be a game-changer?

Apple is finally taking the plunge on AI.

The company on Monday unveiled a suite of new artificial intelligence capabilities that will be available in its newest operating system, including connecting its interactive voice feature Siri with OpenAI’s ChatGPT in a major deal that could supercharge adoption of the fast-developing technology.

Siri, for example, will be able to surface answers from ChatGPT for Apple devices and provide relevant contextual information across several apps, the Cupertino, Calif., tech giant said at its highly anticipated developer conference. The iPhone, Mac and iPad maker’s newest operating system update will also feature AI-augmented improvements in its photo editing and image search capabilities, among other things.

Apple Chief Executive Tim Cook described Apple’s new AI-based functions, dubbed Apple Intelligence, as the next big step for the company, which has been slow to adopt emerging technology that has the potential to change the way people live and work.

“Recent developments in generative intelligence and large language models offer powerful capabilities that provide the opportunity to take the experience of using Apple products to new heights,” Cook said in a keynote address during Apple’s Worldwide Developers Conference, where the company previewed the iOS 18 system and other software updates for products including the Mac and iPad.

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The move signals Apple’s wider ambitions in the expanding AI landscape, as technology has progressed dramatically. Tools made by San Francisco-based OpenAI have been used to create music videos, read bedtime stories to children and help brainstorm ideas for writers. Companies including Microsoft and Google have aggressively incorporated AI into their products and services.

Apple has often not been the first to market with new technological advances, choosing instead to enter new product categories — including smartphones and tablets — once they’ve been established, leading to broader consumer adoption. For example, Apple only began selling its own virtual and augmented reality headset (known as Vision Pro) early this year.

Apple said its AI capabilities were created with privacy protections in mind. Apple Intelligence uses on-device processing. For requests that require use of the cloud, iPhone, iPad and Mac “do not talk to a server unless its software has been publicly logged for inspection” and the data are not retained or exposed, the company said.

Apple presented several uses for Apple’s new AI features. For example, if an iPhone user gets a notification that a work meeting has been moved to a later time, she can ask Siri how much time it would take for her to get from where the meeting is located to her kid’s play that night. In another hypothetical instance, an iPad user could share a photo of an empty patio and ask Siri what plants should be added.

The company also said customers can use Apple Intelligence to make suggestions for their writing, using it to analyze the tone of an email with options to make it more friendly or professional.

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The announcement of the OpenAI deal “kicks off a new frontier for Apple,” said Daniel Ives, a managing director at Wedbush Securities who follows Apple.

“This was a historical day for Apple and Cook & Co. did not disappoint in our view,” Ives, who has an “outperform,” or “buy,” rating on the company’s stock, said in a note to clients. “Apple is taking the right path to implement AI across its ecosystem while laying out the foundation for the company’s multi-year AI strategy across the strongest installed base of 2.2 billion iOS devices over the coming years.”

Investors were less impressed, sending Apple’s stock down 1.9% to $193.12 a share.

Apple hopes adding new AI tools to its products and services will make them more useful to customers and thus more attractive. The company has faced a number of challenges, including slowing device sales in China. Ives said that AI technology introduced to Apple’s ecosystem will bring more opportunities for Apple to generate revenue.

Through its deal with OpenAI, Apple’s digital assistant Siri can ask Apple users if Siri can relay a question to ChatGPT for further information. This allows Apple to harness ChatGPT’s platform and in return, Apple users also become familiar with ChatGPT and what it can do. Every day, Apple said, Siri gets 1.5 billion voice requests.

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ChatGPT will be available for free to Apple users on its newest operating systems for iPhones, iPads and Macs later this year. Apple said its users won’t need an account with ChatGPT to use it on Apple devices. OpenAI won’t store requests and IP addresses will be obscured, the company said.

“Together with Apple, we’re making it easier for people to benefit from what AI can offer,” OpenAI CEO Sam Altman said in a statement.

Some tech companies, including Apple, didn’t anticipate the breakthroughs in AI over the last year, said Rob Enderle, principal analyst with advisory services firm Enderle Group. The partnership with OpenAI is one way for Apple to catch up. One of OpenAI’s major backers is Microsoft, an Apple competitor.

“Apple’s been significantly behind on AI,” Enderle said. “This is a method to allow Apple to make up for the fact that they haven’t been focused on AI like they should have done over the last decade or so.”

Apple Intelligence was one of many announcements and updates from Apple on Monday, including a feature that lets AirPods Pro users nod yes or shake their heads no to Siri’s questions when they are in crowded spaces. Additionally, the company announced that the Vision Pro headset will also be available in additional countries starting later this month, including mainland China, Hong Kong, Japan and Singapore.

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The company also unveiled a new feature called InSight for its tvOS18 that is similar to Amazon’s X-Ray and shows the names of actors or a song playing on an Apple TV+ program.

OpenAI has become the best-known player in the artificial intelligence space, thanks to its tools including ChatGPT and Sora, its text-to-video tool. But the company has faced its fair share of controversies and challenges.

OpenAI last month received backlash from actor Scarlett Johansson, who said she was approached by the startup’s CEO to record her voice for a Siri-like voice assistant version of ChatGPT. After she declined the opportunity, Johansson said, she was upset when she heard what sounded like her voice in a ChatGPT demo.

Altman is known to be a fan of the 2013 movie “Her,” in which Johansson plays “Samantha,” the disembodied voice of a computer who provides friendship and, eventually, love to a lonely man played by Joaquin Phoenix.

OpenAI said that the AI voice, called “Sky,” was not Johansson’s and was recorded by an unnamed voice actor. Nonetheless, the company paused the use of the Sky voice.

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OpenAI recently caught flak for disbanding a team that was tasked with coming up with systems to prevent the rise of artificial intelligence from leading to disaster for humanity. After the firestorm, OpenAI created a new safety committee led by board members, including Altman.

Last week in an open letter, former and current OpenAI employees also raised concerns. The group said that “AI companies have strong financial incentives to avoid effective oversight, and we do not believe bespoke structures of corporate governance are sufficient to change this.”

OpenAI said in a statement said that it believes “rigorous debate is crucial” and it will continue to engage with communities, governments and civil society. The company said it has an anonymous hotline and a safety and security committee.

“We’re proud of our track record providing the most capable and safest AI systems and believe in our scientific approach to addressing risk,” the company said.

Large tech companies are also facing their own challenges, with the U.S. government raising antitrust concerns.

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In March, the Department of Justice sued Apple, accusing the tech giant of stifling competition and leveraging its clout and ownership of the popular App Store to increase prices for customers. Apple said the lawsuit threatens “who we are.”

“If successful, it would hinder our ability to create the kind of technology people expect from Apple — where hardware, software, and services intersect,” Apple said in a statement.

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