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Saturday, June 29, 2024

'It's a mess': Biden turns to family on his path forward after his disastrous debate

 President Joe Biden is expected to discuss the future of his re-election campaign with family on Sunday, following a nationally televised debate Thursday that left many fellow Democrats worried about his ability to beat former President Donald Trump in November, according to five people familiar with the matter.

Biden’s trip to Camp David was planned before Thursday’s debate. He and first lady Jill Biden are scheduled to join their children and grandchildren there late Saturday.

So far, the party’s top leaders have offered public support for Biden, including in tweets posted by former presidents Barack Obama and Bill Clinton. Senior congressional Democrats, including Reps. Hakeem Jeffries of New York, Jim Clyburn of South Carolina and Nancy Pelosi of California, have privately expressed concerns about his viability, said two sources apprised of those discussions, even as they all publicly back the president.

One Democratic House member who believes Biden should drop out of the race — but has yet to call for that publicly — told NBC News that three colleagues expressed the same sentiment to him during votes on the House floor Friday.

At the same time, there is an understanding among top Democrats that Biden should be given space to determine next steps. They believe only the president, in consultation with his family, can decide whether to move forward or to end his campaign early — and that he won’t respond well to being pushed.

“The decision-makers are two people — it’s the president and his wife,” one of the sources familiar with the discussions said, adding: “Anyone who doesn’t understand how deeply personal and familial this decision will be isn’t knowledgeable about the situation.”

This account of a president and his party in crisis just a little more than four months before an election they say will determine the fate of democracy is drawn from interviews with more than a dozen Democratic officials, operatives, aides and donors. All of them spoke on the condition of anonymity in order to describe matters as sensitive as whether a sitting president might give up his re-election bid and how he could be replaced on the ballot.

Despite delivering a rousing speech at a rally in North Carolina on Friday that calmed some of his allies, Biden was described by one person familiar with his mood as humiliated, devoid of confidence and painfully aware that the physical images of him at the debate — eyes staring into the distance, mouth agape — will live beyond his presidency, along with a performance that at times was meandering, incoherent and difficult to hear.

“It’s a mess,” this person said.

Another person familiar with the dynamics said Biden will ultimately listen to only one adviser.

“The only person who has ultimate influence with him is the first lady,” this person said. “If she decides there should be a change of course, there will be a change of course.”

Anita Dunn, one of Biden’s handful of closest advisers, said on MSNBC’s “The Weekend” Saturday that Biden has not discussed dropping out of the race with aides and that internal talks have focused on moving forward.

“We had a bad debate,” Dunn said. “What do we do next? You know, the president, above all, is focused on what do we do next? What do I need to go do?”

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These private discussions among Biden, his family members and his top advisers are being held against the backdrop of a reckoning for Democrats who were shocked both by Biden’s appearance and the frequency with which his train of thought appeared to veer off track.

His campaign held a conference call Saturday with members of the Democratic National Committee, which a Biden campaign official described as an effort to reassure party officials and demonstrate that his team is communicating with its allies.

“We’re driving this,” the official said.

House leaders have not wavered publicly, and their aides denied that they are expressing doubts behind closed doors.

“Speaker Pelosi has full confidence in President Biden and looks forward to attending his inauguration on January 20, 2025,” Ian Krager, a spokesman for the former House speaker said. “Any suggestion that she has engaged in a different course of action is simply not true.”

Christie Stephenson, a spokeswoman for Jeffries, the House minority leader, said her boss has “repeatedly made clear publicly and privately that he supports President Joe Biden and the Democratic ticket from top to bottom.”

Clyburn’s office did not reply to a request for comment, but he told reporters Friday that he is still with Biden.

Biden’s top aides and advisers have told his staff to stay the course in meetings and discussions. Their message, according to one senior administration official: “We’ll weather the storm, just like we always have.”

Sources have described three buckets of Democrats: those who will defend Biden under any circumstances, those who are ready to dump him, and those who are waiting to see what he does — and what his poll numbers look like in the coming days and weeks — before passing judgment. It’s the third bucket that Democratic insiders are monitoring closely.

“Democrats need to take a big breath and look at that polling, look at swing voters,” said one state Democratic Party chair. “Until I see something differently, he’s the person that’s put this coalition together, he’s the person that has the record, he’s the person that beat Donald Trump. Until I see something differently, he’s still the best person to beat Donald Trump.”

The Biden campaign declined to comment for this piece, instead pointing to a memo Saturday from campaign chair Jen O’Malley Dillon that made the case that Biden can still win, pointing to the more than $27 million they raised between debate day and Friday evening.

Notably, however, O’Malley Dillon nodded to the possibility that there might be some tough polling ahead — but said the blame will rest with the media: “If we do see changes in polling in the coming weeks, it will not be the first time that overblown media narratives have driven temporary dips in the polls.”

The discussions among some Democrats include weighing what the party’s best path to defeating Trump might be — sticking with an 81-year-old incumbent who could have another moment like Thursday night at any time between now and Election Day, or going with a different candidate whose path to nomination at the party’s convention next month could be a messy process.

Biden insisted Friday that he will remain the party’s standard-bearer in November, telling a crowd at his rally in Virginia, “I would not be running again if I didn’t believe with all my heart and soul I can do this job.”

The president has spent much of the past 48 hours attending fundraising events with some of the very Democrats most concerned about the impact of his debate performance.

He addressed it head-on at one event Saturday.

“I understand the concern about the debate — I get it,” he added. “I didn’t have a great night.”

Party elites will urge him to exit the race only if they determine that he is “not viable and negatively impacting the House and Senate races,” said one big-time donor who is close to both Obama and Biden.

Inherent in the wait-and-see approach is an acknowledgment that there is no clear replacement for Biden and that his departure could touch off a bloody eleventh-hour intraparty battle that might allow Trump to cruise to victory.

There’s also no feasible way to force him from his perch. All but a handful of the delegates to the Democratic convention were elected on their pledge to nominate him at the party’s convention in August. If he chooses to stand for that nomination, party insiders say, he will get it.

Moreover, according to a senior Democratic official, the party leadership would have much more control over choosing a replacement if Biden were to drop out after receiving the nomination than if he did so beforehand. Once a candidate is officially nominated, there is a process for the Democratic National Committee members to choose a successor. Biden is the dominant force at the DNC, and his preference for a successor would surely carry sway.

If Biden were to exit before that, his delegates might do what he asked of them — but they wouldn’t be bound in the same way they are now. In that scenario, the delegates could nominate anyone, and there could be a political brawl at the convention.

“We need to have as much discipline as emotion,” the senior Democratic official said. “It’s not politically smart for Biden to step down.”

https://www.nbcnews.com/politics/2024-election/biden-family-path-forward-disastrous-debate-mess-rcna159591

New Drugs Turned Down by EU Safety Assessor

 The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given negative opinions for two drugs intended to treat amyotrophic lateral sclerosis (ALS) and age-related macular degeneration (AMD). It also recommended nonrenewal of a conditional authorization for a Duchenne muscular dystrophy medication.

ALS Medicine Not Recommended 

At its June 2024 meeting, the CHMP said that it recommended refusal of marketing authorization for masitinib (AB Science), a medicine intended to treat ALS. Its active substance, masitinib mesylate, is a protein kinase inhibitor that blocks enzymes involved in various immune-mediated inflammatory processes. The expectation was that this would reduce inflammation and protect nerve cells from damage, thereby slowing the worsening of ALS symptoms.

Masitinib, which was given orphan drug designation in 2016, is an oral tablet intended to be used in combination with riluzole, a drug indicated to extend life or time to mechanical ventilation in patients with ALS but which has no therapeutic effect on motor function, lung function, fasciculations, muscle strength, or motor symptoms. 

AB Science presented evidence from a trial of 394 adults with ALS treated with masitinib or placebo, both in combination with riluzole, twice daily for 48 weeks. The main measure of effectiveness was the change over 48 weeks in an ALS-specific quality-of-life score. However, the CHMP said, drug benefits could not be convincingly demonstrated. The trial found no difference between the active drug and placebo in the main measure of effectiveness and had several methodological issues that made the data unreliable.

The European Medicines Agency's opinion therefore was that the benefits of masitinib did not outweigh its risks. There are no consequences for patients in ongoing clinical trials with the drug, and the company may ask for reexamination of the opinion within 15 days.

AMD Drug Not Recommended 

The CHMP also did not recommend marketing authorization for Syfovre (pegcetacoplan; Apellis Europe B.V.), a drug intended to treat geographic atrophy secondary to AMD. Geographic atrophy is an advanced form of dry AMD in which lesions form in the retina and macula, causing large, well-demarcated sections of the retina to stop functioning, leading to irreversible loss of vision.

With geographic atrophy, the complement system is overactive, leading to inflammation and cell death in the retina. The drug's active substance is pegcetacoplan, which is injected into the eye as a solution. It works by blocking the C3 protein of the complement system, thus preventing complement activation and slowing the growth of atrophic lesions.

The company presented results from two main trials involving 1258 adults with AMD and geographic atrophy. Pegcetacoplan injections were compared with sham procedures, and any changes in lesion size were examined 12 months later.

The CHMP said that although the results showed that pegcetacoplan did slow the growth of lesions, this did not lead to clinically meaningful benefits for patients. Given the risks of regular injections into the eye, the CHMP said that a positive balance of benefits and risks could not be established, and it recommended refusing marketing authorization.

Again, there are no consequences for patients taking the drug as part of a clinical trial, and the company may ask for reexamination of the opinion within 15 days of receiving it.

Conditional Authorization for Translarna Not Recommended for Renewal

The CHMP also recommended not renewing the conditional marketing authorization for Translarna (ataluren; PTC Therapeutics), a medicine for treating some patients with Duchenne muscular dystrophy.

Translarna is used in patients whose disease is caused by a nonsense mutation in the dystrophin gene and who are still able to walk. An initial negative opinion on the renewal of its marketing authorization was given last September and was confirmed in January this year, following a reexamination requested by the company. The CHMP said that following reevaluation of the drug's benefits and risks, both rounds of assessment had concluded that Translarna's effectiveness had not been confirmed.

Last month, the European Commission had asked the CHMP to further consider whether new data from a scientific advisory group on neurology convened in March this year affected its conclusions on the medicine's benefit-risk balance. Further publications were reviewed, along with input from parents or caregivers of boys affected by Duchenne muscular dystrophy, patient organizations, healthcare professional organizations, and treating doctors, as well as reports on individual patients treated with Translarna.

The CHMP concluded, after a thorough assessment of the totality of the data, that despite the high unmet medical need for an effective treatment for patients with this rare disease, there was still insufficient evidence to confirm Translarna's effectiveness. Therefore, the benefit-risk balance was negative and the CHMP recommended not renewing its marketing authorization in the EU.

This opinion will now be forwarded to the European Commission for a final legally binding decision applicable in all EU member states.

https://www.medscape.com/viewarticle/eu-safety-assessor-turned-down-new-drugs-2024a1000c44

Amazon probing AI startup Perplexity for ‘scraping’ websites without permission: report

 Amazon is investigating buzzy AI startup Perplexity for allegedly violating its Cloud division’s rules by improperly “scraping” content from other websites without permission, according to a report Friday.

Perplexity, which recently drew a $3 billion valuation, is allegedly ignoring a well-known web standard called the Robots Exclusion Protocol, commonly referred to as robots.txt, which news publishers and other sites use to show automated bots which pages they aren’t allowed to scrape, tech outlet Wired reported.

While adhering to the standard isn’t required by law, most internet firms opt to follow the protocol. Compliance is also mandatory for websites that rely on Amazon Web Services, such as Perplexity.

“AWS’s terms of service prohibit abusive and illegal activities and our customers are responsible for complying with those terms,” an Amazon Web Services spokesperson said in a statement. “We routinely receive reports of alleged abuse from a variety of sources and engage our customers to understand those reports.” 

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Scrutiny of Perplexity’s practices has intensified after Forbes accused the company earlier this month of “directly ripping off” articles written by its reporters and others by CNBC and Bloomberg, including those that were behind paywalls.

Wired approached Amazon after its own investigation determined that Perplexity allegedly used an “unpublished IP address” to scrape websites operated by its parent company Condé Nast — even though it was trying to block access.

The outlet said that representatives from other outlets, including Forbes, the New York Times and the Guardian, had detected the same IP address visiting their servers.

Perplexity spokesperson Sara Platnick pushed back on Wired’s report, calling it “inaccurate.”

“Our PerplexityBot — which runs on AWS — respects robots.txt, and we confirmed that Perplexity-controlled services are not crawling in any way that violates AWS Terms of Service,” Platnick said in a statement.

“AWS looked into WIRED’s media query as part of a standard protocol for investigating reports of abuse of AWS resources,” Platnick added. “We had not heard anything from AWS prior to a WIRED reporter contacting them. To say that AWS is ‘investigating’ Perplexity outside of this specific WIRED inquiry is incorrect. AWS is a valuable partner to Perplexity and we are grateful for their ongoing collaboration.”

Platnick told Wired that the PerplexityBot would bypass the robots.txt protocol in “very infrequent” circumstance that a user included a specific URL in their query.

Perplexity CEO Aravind Srinivas had previously slammed Wired’s findings, asserting that they “reflect a deep and fundamental misunderstanding of how Perplexity and the Internet work.” 

Forbes had taken issue with a feature called “Perplexity Pages,” a product that displays “curated” articles that pull details from articles written by third-party news outlets.

The original authors weren’t credited by name, even when the wording of Perplexity’s posts closely matched that of the source text.

Forbes accused Perplexity of “directly ripping off” its work.perplexity.ai

Instead, Perplexity used what Forbes described as “small, easy-to-miss logos” linking back to the original sources.

In one egregious example, Perplexity’s chatbot churned out a version of an exclusive, paywalled Forbes report on ex-Google CEO Eric Schmidt’s military drone project.

“Our reporting on Eric Schmidt’s stealth drone project was posted this AM by @perplexity_ai,” Forbes Executive Editor John Paczkowski wrote on X at the time. “It rips off most of our reporting. It cites us, and a few that reblogged us, as sources in the most easily ignored way possible.”

Srinivas said the tool “has rough edges” but otherwise denied wrongdoing.

https://nypost.com/2024/06/28/business/amazon-probing-ai-startup-perplexity-for-scraping-sites-without-permission/