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Kim Kardashian misleads fans, FDA strikes back

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“OMG. Have you heard about this?”

That was Kim Kardashian West writing on Instagram last month. The subject of her enthusiasm: a morning sickness drug.

As much of the world can’t help knowing, Kardashian is pregnant and has been struggling with, as she put it, “#morningsickness.” So she enthusiastically reported to her tens of millions of social media followers that she was now feeling “a lot better” after taking Diclegis, a prescription morning-sickness medicine.

Declaring that “it’s been studied and there was no increased risk to the baby,” she urged other women to ask their doctors about it. And she posted a photo of herself holding a bottle of the pills.

The post was perhaps the most prominent recent example of a practice that has been troubling federal regulators: the chatty, seemingly casual promotion of medicines and other products by celebrities on Twitter, Facebook and other social media.

The Food and Drug Administration struck back against Kardashian’s post, issuing a warning letter (which it made public this week) to the drug’s maker, Duchesnay Inc., that said the post failed to give information about the drug’s risks. The letter ordered the company to “immediately cease misbranding.”

It was the latest among several actions the agency has taken against posts on sites like Facebook and YouTube. Thomas Abrams, the director of the drug promotion office, said in a 2013 interview that social media had complicated the agency’s ability to monitor drug promotions, citing the sheer volume of content online and the speed with which it can be changed.

“It is important to know that although we closely monitor what companies say, we generally do not have authority over statements made by independent organizations or persons – what we call third parties – unless they are acting on behalf of a company,” he said.

The Federal Trade Commission, which monitors over-the counter drugs, has also issued guidelines about celebrity endorsements, including that they be bona fide users of the product and disclose any financial arrangement.

In the case of Kardashian, she disclosed in the post that she was “partnering” with the Pennsylvania-based subsidiary Duchesnay USA to “raise awareness about treating morning sickness,” and she included links to websites for the drug and its safety information. But Robert T. Dean, a director at the FDA’s Office of Prescription Drug Promotion, who signed the letter, said that was not enough.

“By omitting the risks associated with Diclegis, the social media post misleadingly fails to provide material information about the consequences that may result from the use of the drug and suggests that it is safer than has been demonstrated,” he wrote.

Diclegis is the only medicine currently approved for morning sickness in the United States. Potential side effects include heavy drowsiness. Dean also noted that the drug had not been tested in women with hyperemesis gravidarum, a condition marked by severe nausea and vomiting.

The company would not share details of its arrangement with Kardashian. But responding to questions, a Duchesnay executive said in a statement that the company had contacted Kardashian after hearing she had morning sickness and that she told the company she had been prescribed Diclegis. After Kardashian posted her Instagram message praising the drug July 19, the company issued a statement the next day, applauding her for encouraging pregnant women to talk to their health care provider.

Asked whether the company had helped Kardashian write the Instagram post and how much she was paid, Dean Hopkins, the general manager of Duchesnay USA, said in the statement: “Unfortunately, the details of our partnership are private.”

The posts appear to have been taken down.

“Duchesnay USA takes its regulatory responsibilities very seriously, and acknowledges that its communications, including in social media as in this particular instance, need to be in accordance with applicable rules and regulations,” a statement from the company said.

In 2008, an online page and video testimonial on YouTube featuring Ty Pennington, the host of “Extreme Makeover: Home Edition,” was the subject of an FDA warning letter to Shire, the makers of Adderall XR. It said the video overstated stated the efficacy of the drug and suggested uses that were not approved by the agency.

An excerpt from Pennington’s statement was included in the letter: “Now once I got on medication it’s just amazing the transformation I made. I – It literally changed my life, and gave me the confidence to achieve my goals, like being an artist.”

The FDA said that overstated the efficacy of Adderall XR by implying that it would transform patients’ lives and improve their confidence. The posts were removed and the company complied with other requests in the letter.

Kardashian’s Instagram post, which was linked to her other social media accounts, was reported through the FDA’s “Bad Ad” program that takes tips about misleading advertising and promotions.

Celebrities have considerable history of U.S. medical endorsements. In 2002, U.S. television stations started to investigate celebrity ties to drug companies after stars like Lauren Bacall and Kathleen Turner were paid to help promote drugs or other medical products on their programs.

Their ability to connect with fans on social media has made them even more attractive to companies; Kardashian has more than 40 million followers on Instagram.

Michael A. Carome, director of the Public Citizen’s Health Research Group, a consumer advocacy group, said the United States and New Zealand were the only two countries that allow such direct-to-consumer marketing by celebrities in broadcast forums and online.

Even if the celebrities did reveal their connections to the drug companies – as Kardashian did – as well as the drug risks, having a celebrity deliver a positive message about a drug just makes things worse, he said.

“The company wants to add a celebrity not because the celebrity is better educated, but that the simple presence of the celebrity will pressure doctors to prescribe that product,” Carome said. “It does not make the message any more valid from a health care perspective.”

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Keanu Reeves Returns with “The Matrix Resurrection”

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Matrix Resurrections 2021 | News Aur Chai

The expectation of the unexpected fourth instalment of The Matrix Resurrections in the sci-fi establishment has started with another banner prodding the arrival of its first trailer.

The film Matrix 4 comes out 18-years after The Matrix Revolutions. It is planning to be the last film in a trilogy reporting the transformation of Computer programmer Thomas Anderson into cybercriminal Neo. As he finds the conventional world, he occupies a recreated reality.

Loosening up the expectation, with a special promotional. It highlights red and blue pills sit next to each other underneath the clear message: ‘The Choice is yours.’ Fans of the famous establishment will perceive the pills as a definitive choice given to Neo, played by Keanu Reeves, as he picks between life in the conflict assaulted real world or the ‘beautiful prison’ of a substitute reality. Penetrating static fills in as the scenery, as small strings of Matrix code has seen falling inside the pills before the whole scene liquefies.

Fans can proceed with their adventure on WhatIsTheMatrix.com, an intelligent pick your-own-experience style site. Given a similar decision there, red brings you down a rabbit hole where you’re told: ‘This is the moment for you to show us what’s real.’ Then scenes from the film teaser, showing the slight hindrance between the natural world and the fake world known as The Matrix. One of the Best Scenes is Reeves’ Neo gulping a blue pill while a lot more seasoned, a balder man shows up in his appearance.

The scenes reviewed rely upon which pill selection and each emphasis on the decision made. The Red Pill requests that the watcher go further into the reality behind the Matrix. While the Blue Pill cautions them to avoid it again so as not to agitate the norm and welcome undesirable risk.

Still, the viewer’s decision makes, in any case, every secret seems to end with a brief look at Keanu Reeves as Neo, with different eyes. He either collaborates with characters who could be his partners in the film or plans to fight against its expected scalawags, be they Agents, pernicious projects, or even people.

The person who clicks on the blue pill will hear Harris’s voiceover saying: “You’ve lost your capacity to discern reality from fiction.” Before encouraging the viewer to embrace that their situation is genuine. At the current time, streaks on the screen, and Harris peruses it, saying, “anything else is your mind playing tricks on you.” By contrast, ones’ who click on the red pill hear Abdul-Mateen’s voice revealing to them that while they trust it’s the current time — once more. With Abdul-Mateen perusing the time out loud — “that couldn’t be further from the truth.” Regardless, a progression of quick-cut shots from “Revivals” streaks on the screen during the two situations. As each time a viewer taps on a pill, the recording changes.

‘This could be this is the first day of the rest of your life, but if you want it, you gotta fight for it.’ The portrayal wraps while showing star Keanu Reeves prepared to battle. Then, at that point, finishing on a vile note, they show somebody contacting the PC port at the rear of their head and inquire: ‘We don’t want anyone to get hurt, do we?’

From visionary movie producer Lana Wachowski. The new film reunites unique stars Keanu Reeves and Carrie-Anne Moss as Neo and Trinity, the infamous roles they made well known.’ The first Matrix film in 1999 met with much essential acclaim upon its introduction. The element is following up by two other movies, which were both delivered in 2003. Warner Bros. uncovered the title for the fourth Matrix film during its CinemaCon board. The Matrix Resurrections will release on December 22, 2021.

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Bo Burnham’s Inside: A Quarantine Classic

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Bo Burnham's Inside | News Aur Chai

After a break of six long years with no live performances, fans worldwide were psyched when Bo Burnham announced the release of his comedy special in May 2021.

“Inside” is a comedy special directed, written, filmed, edited by, and starring Bo Burnham. The whole film is taped inside his home during the COVID-19 without a crew or audience.

Since its release, social media sites have been flooded with reactions to this comedy special, claiming it to be a masterpiece. The film’s songs have the viewers hooked, and obliviously, one may find oneself repeating the lyrics.

The epic “cinematic selfie” by Bo Burnham nabs a rating of 8.9/10 IMBD rating and a gush of positive reviews all over the internet. Without a smidgen of doubt, Bo Burnham has indeed made a spectacular comeback with his special. “Inside” is a whirlwind of emotions wrapped up in a 90-minute long film.

According to the review aggregator Rotten Tomatoes, “Inside is a beautifully bleak, hilariously hopeful special from Bo Burnham.”

In the special, Burnham tackles topics like life, death, hypocrisy and mental illness. Burnham performs in a single room, without a crew or audience, giving timely updates about the days that passed while working on this special. One can notice his hair and beard growing throughout the film. The film showcases an exceptional range involving drama, comedy, and emotions. The first half of the show gives the audience fits of laughter; the second will have them close to tears, grabbing for tissues.

The 90-minute long special is a non-chronological record of the days in Burnham’s life. It starts on a positive note with a song — a promise to “heal the world with comedy”, reflecting on his ‘white-savior complex’.

The show also involves Burnham turning 30 and an intense yet light debate about geopolitics with a sock puppet. There is a repetitive commentary by the host on the footage of his previous scenes. The highlight of the special is its songs which include commentary on topics like the similarities between white women’s Instagrams, Jeff Bezos, and digital isolation.

Burnham also reveals why he stepped away from comedy five years ago; he started suffering from severe panic attacks on stage. However, his mental health had improved since January 2020, enough for him to return. But then, according to him, “the funniest thing happened”, referring to the world being struck with the COVID-19 pandemic.

The show ends on a sarcastic note with him singing, “I promise to never leave this room”; a statement made in an atmosphere that will definitely leave you sitting at the edge of your seat wondering as to ‘will he?’.

You can now stream “Inside” by Bo Burnham on Netflix.

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Money Heist Announces Season 5 With Electrifying Teaser Trailer

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Money Heist Season 5 II News Aur Chai

“This is more than a heist. This is war.” With the Army hot on the heels of The Gang, the fight for their lives is more imminent than ever. ‘La Casa De Papel’ or the popularly dubbed ‘Money Heist’ announced that its final season would be released in two instalments. This is a first for the show, which has divided each heist into two seasons thus far. The trailer drops the dates — the first cour will hit Netflix on September 3. The second volume will follow three months later, on December 3. The 10-episode season will be split into five episodes per volume.

 

Emotions and fear are running high, palpable on the faces of the heist crew as the clock ticks past 100 hours of their entrapment. Slow-motion shots of each person capture the burning fire to avenge their fallen comrade’s death. Power-packed with artillery fire from both ends, the teaser hints that not everyone will make it out alive. Show makers ditch their hallmark ‘Bella Ciao’ favouring 2WEI’s cover of Linkin Park’s ‘In the End’. The score builds up anticipation and amps up the audience for the devastating destruction it promises.

Glimpses of a lone tear escaping a defeated Lisbon and the almighty Professor struggling helplessly with tied hands sow fear into our hearts. With the Army thrown into the mix and the Professor compromised, what fate awaits The Gang? Is the Professor truly out of commission, at the mercy of Inspector Sierra? With no escape plan hidden up his sleeve, the show creator guarantees “the most epic and exciting season.”

The final season began filming on August 3, 2020, while the Instagram page announced its wrap on May 14, 2021. Written entirely during the pandemic, creator Álex Pina felt the need to flip expectations on their head. Pina says, “[they] used every tool we could to create the sensation of a season finale or series finale in the first volume itself. We decided to work in an extremely aggressive genre, putting The Gang on the ropes.”

With volume 1 going into overdrive with thrilling action, volume 2 aims to do justice to the final split-up of the gang. “In volume 2, we focus more on the emotional situation of the characters. It is a journey across their sentimental map that connects us directly to their departure,” Pina adds.

The Spanish drama took the world by storm, and bidding adieu to these characters, who have been through hell and back, will be a daunting task. However, Pina isn’t ready either, dreaming up possibilities of future spinoffs. Praising the complex and layered character design, he says, “We do have many possibilities for some spinoffsspinoffs, and I think that’s thanks to the strong and powerful identities of the characters. So, I think almost every character of Money Heist has a duality that we would like to see in a spinoffspinoff. We could watch any of them in other contexts.”

Season 5 of ‘Money Heist’ will see a majority of the cast reprising their roles — Álvaro Morte (The Professor), Úrsula Corberó (Tokyo), Pedro Alonso (Berlin), Itziar Ituño (Lisbon), Najwa Nimri (Inspector Sierra), Jaime Lorente (Denver), Miguel Herrán (Rio), Esther Acebo (Monica), among others.

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