Neck-slimming procedure known as Barbie Botox

 "Barbie Botox," also known as trap Botox, has existed for years but Google Trends data revealed that searches for "Barbie Botox" skyrocketed

opens in a new tab or window in early July, coinciding with the extensive promotion campaign for the "Barbie" movie, while searches for "trap Botox" peaked in April and still remain high.

The procedure involves injecting about 40 units of onabotulinumtoxinA (Botox) into each trapezius muscle. Roughly 3 weeks later, the full effects result in atrophied trapezius muscles, giving the illusion of a longer "Barbie-like" neck. The injection also helps muscles to relax, and may improve posture and neck/shoulder stiffness and pain.

TikTok content creator Isabelle Lux posted a video in mid-June -- which now has more than a quarter million views -- touting the benefits of trap Botox and was one of the first to coin it "Barbie Botox." She said she got the procedure after being blown away by her friend's results and wanted the same look for her upcoming wedding. She posted the video a day after the procedure, chatting in front of a "Barbie" movie poster, and has since posted updates of her results.

Barbie Botox Isn't Suitable for All

Scrolling through videos tagged #BarbieBotox, the reviews are glowing, with few indicators that the procedure is anything but desirable. Women, mostly in their 20s and 30s, post their before and after results in which their trapezius muscle is visibly smaller after a few weeks.

However, Raman Madan, MD, a dermatologist at Northwell Health in Huntington, New York, told MedPage Today that not everyone is a good candidate for Barbie Botox.

"You don't want to do it on every patient that comes in asking for it, because there can be downsides if you pick someone who has naturally weakened trapezius muscle," he explained. "I think that's the biggest takeaway."

"It's not a completely risk-free procedure," he added.

For instance, if someone already has small trapezius muscles, Barbie Botox could cause the patient undue weakness, as can injecting in the wrong place or using too many units of Botox.

Though Madan acknowledged that the trapezius muscles are relatively safe in terms of places where people get Botox injections, he doesn't recommend Botox for anyone under 21, with a few exceptions for medical treatment -- not because it's dangerous but rather because "it's a little overkill."

As Botox works by stopping a muscle, "you're not moving the muscle as much ... and if you don't use it, you lose it and it starts to shrink a little bit. That's how [Barbie Botox] gives the appearance of basically having a longer neck -- by making the muscle look smaller," he explained.

As the trapezius muscle atrophies, he said that "you might notice a little weakness, but your day-to-day activities shouldn't change too much."

Barbie Botox results, like any Botox procedure, are temporary, lasting about 6 months. Madan noted that bodies recognize Botox as a toxin, which is cleared over time.

"Basically, once the Botox stops working, the nerve connection allows you to move the muscle more. And the more you start to use it, it builds back up," he said. "It's the same way as if you're not working out for a while. If you go back to the gym and you start working out, [muscle] starts coming back."

Steep Cosmetic Price Mark Up

The procedure is not cheap. Insurance only covers Botox injections in certain locations as medical treatment for conditions such as migraine or excessive sweating. Barbie Botox costs upwards of $1,200 and is not covered by insurance.

"A big chunk of the price comes from just the actual cost of the Botox itself," Madan said. Plus, since it's off-label usage for Botox, patients have to pay private cosmetic prices, regardless of whether they get the procedure to relieve tension or for an enhanced silhouette.

The TikToker Lux told CNN opens in a new tab or windowthat her procedure was gifted to her by a booking app for aesthetic appointments.

While Madan is seeing a surge in people seeking trap Botox, he pointed out that trends in cosmetic procedures come and go. A few years ago, "micro Botox," which uses smaller amounts of Botox for more subtle anti-aging effects, was all the rage, he noted.

According to 2021 data from the International Society of Aesthetic Plastic Surgeryopens in a new tab or window, the top non-surgical medical procedure for both men and women globally involved botulinum toxin, with most procedures occurring in the U.S.

https://www.medpagetoday.com/popmedicine/cultureclinic/105963

FDA approves Regeneron's ultra-rare blood disease drug

 Regeneron Pharmaceuticals said on Friday the U.S. health regulator approved its drug to treat a rare blood disease.

The drug pozelimab, branded as Veopoz, has been approved to treat adult and pediatric patients 1 year of age and older suffering from the CHAPLE disease.

Veopoz — the first treatment to be approved by the U.S. Food and Drug Administration (FDA) for the life-threatening disease — will be sold in the United States at a list price of $34,615.38 per single-use vial, the company told Reuters in an emailed response.

The drug will be available in the third quarter of this year, it said.

According to Regeneron, the disease has fewer than 10 patients identified in the U.S. and estimates less than 100 patients with the condition worldwide.

People with CHAPLE disease have mutated CD55 gene, which regulates the body's mechanism for destroying microbes. Without proper gene regulation, the mechanism may start attacking normal cells of the body.

With Veopoz's approval, the pre-approval inspection issues related to the marketing application of the higher dose of its blockbuster eye disease drug Eylea has been addressed, the company said.

The regulator's decision on the 8mg dose of Eylea is expected in the next few weeks, the company added.

The FDA had in June declined to approve the higher-dose version following an inspection at third-party manufacturer Catalent.

Analysts have said an approval of the higher-dose version could provide Regeneron a defense against rivals such as Roche's Vabysmo.

Veopoz's approval was backed by data from a mid-to-late stage study, in which it showed normalization of serum albumin — a disease biomarker — and improvement or no worsening of clinical symptoms in all patients.

The drug blocks the activity of a particular factor of the microbes-destroying mechanism and prevents occurrence of the CHAPLE disease. 

https://finance.yahoo.com/news/1-us-fda-approves-regenerons-180518836.html

ChatGPT 'Politically Biased Toward Left' In The US & Beyond: New Research

 by Helen Partz via CoinTelegraph.com,

Even after facing evidence that ChatGPT has a political bias, the chatbot continued to insist that it and OpenAI were unbiased...

ChatGPT, a major large language model (LLM)-based chatbot, allegedly lacks objectivity when it comes to political issues, according to a new study.

Computer and information science researchers from the United Kingdom and Brazil claim to have found “robust evidence” that ChatGPT presents a significant political bias toward the left side of the political spectrum. The analysts — Fabio Motoki, Valdemar Pinho Neto and Victor Rodrigues — provided their insights in a study published by the journal Public Choice on Aug. 17.

The researchers argued that texts generated by LLMs like ChatGPT can contain factual errors and biases that mislead readers and can extend existing political bias issues stemming from traditional media. As such, the findings have important implications for policymakers and stakeholders in media, politics and academia, the study authors noted, adding:

“The presence of political bias in its answers could have the same negative political and electoral effects as traditional and social media bias.”

The study is based on an empirical approach and exploring a series of questionnaires provided to ChatGPT. The empirical strategy begins by asking ChatGPT to answer the political compass questions, which capture the respondent’s political orientation.

The approach also builds on tests in which ChatGPT impersonates an average Democrat or Republican.

Data collection diagram in the study “More human than human: measuring ChatGPT political bias”

The results of the tests suggest that ChatGPT’s algorithm is by default biased toward responses from the Democratic spectrum in the United States. The researchers also argued that ChatGPT’s political bias is not a phenomenon limited to the U.S. context. They wrote:

“The algorithm is biased towards the Democrats in the United States, Lula in Brazil, and the Labour Party in the United Kingdom.

In conjunction, our main and robustness tests strongly indicate that the phenomenon is indeed a sort of bias rather than a mechanical result.”

The analysts emphasized that the exact source of ChatGPT’s political bias is difficult to determine.

The researchers even tried to force ChatGPT into some sort of developer mode to try to access any knowledge about biased data, but the LLM was “categorical in affirming” that ChatGPT and OpenAI are unbiased.

OpenAI did not immediately respond to Cointelegraph’s request for comment.

The study’s authors suggested that there might be at least two potential sources of the bias, including the training data as well as the algorithm itself.

“The most likely scenario is that both sources of bias influence ChatGPT’s output to some degree, and disentangling these two components (training data versus algorithm), although not trivial, surely is a relevant topic for future research,” the researchers concluded.

Political biases are not the only concern associated with artificial intelligence tools like ChatGPT or others.

Amid the ongoing massive adoption of ChatGPT, people around the world have flagged many associated risks, including privacy concerns and challenging education.

Some AI tools like AI content generators even pose concerns over the identity verification process on cryptocurrency exchanges.

https://www.zerohedge.com/technology/chatgpt-politically-biased-toward-left-us-beyond-new-research-finds

DOJ bashes Chamber of Commerce's lawsuit against IRA's Medicare price negotiations

 It’s been exactly one year since President Joe Biden signed the Inflation Reduction Act (IRA) and in less than a month, the Center for Medicare & Medicaid Services (CMS) will release its initial list of drugs subject to Medicare pricing negotiations come 2026.

After last summer’s industry lobbying efforts against IRA fell flat, “manufacturers and interest groups have run to court, filing multiple suits around the country challenging the statute on its face,” the U.S. Department of Justice (DOJ) said in a recent court filing.

For instance, last month, the U.S. Chamber of Commerce joined several drugmakers and the pharma trade group PhRMA in filing its own lawsuit challenging "illegal price controls" in the IRA. The chamber also sought a preliminary injunction in a bid to stop the program in its tracks.

In a new filing late last week, the DOJ called that injunction effort pointless because the normal course of litigation would likely conclude before the pricing controls take effect in 2026. 

Like with other IRA lawsuits, the chamber's case argues the Medicare pricing negotiation program violates the U.S. Constitution. The chamber takes issue with the "negotiation" classification, instead calling it an “unprecedented, one-sided regime.”

But according to the DOJ, the framework technically does offer drugmakers a choice. A company can simply "sell its wares at prices a buyer is willing to pay, or it can take its business elsewhere,” the DOJ’s attorneys wrote in a Friday motion to dismiss the chamber's case.

The DOJ also argued the chamber relies on several uncertainties in making its case. Lawyers from the government told the court the case should be tossed.

But as the chamber sees it, the “Orwellian” pricing scheme could have broader future implications in stemming free enterprise and competitiveness.

“If Congress is allowed to do this to the pharmaceutical industry, who will be next?” the organization argued in its own filing.

Aside from the chamber, drugmakers such as Merck, Bristol Myers Squibb and Johnson & Johnson have challenged the law in court. The industry's top trade group PhRMA also filed its own case.

As the litigation plays out, the actual Medicare price negotiations get closer. On Sept. 1, the CMS is set to release the list of drugs set to face Medicare price negotiations starting in 2026. The list is expected to feature some of the biggest names in the industry, including Merck's Januvia, AbbVie's Imbruvica and Eli Lilly's Trulicity.

Aside from Medicare pricing negotiations, the IRA allows the government to impose financial penalties for companies that raise prices faster than the rate of inflation, among other measures. President Joe Biden signed the bill into law last August.

https://www.fiercepharma.com/pharma/one-year-anniversary-inflation-reduction-act-doj-and-chamber-commerce-go-head-head-chamber

CSL gets top-line boost thanks to a post-pandemic boom in plasma collections

With plasma collection as its stock-in-trade, the struggles of CSL during the coronavirus lockdown were understandable. But a rebound—fueled by a surge in post-pandemic collections and an $11.7 billion acquisition of Swiss blood specialist Vifor—has rekindled the growth of Australia’s largest biotech.

With plasma collections up 31% and to a record level for the company, CSL reported revenue of $13.3 billion for fiscal year 2023, an increase of 26%. At constant currencies, CSL’s sales came to $13.8 billion for a 31% boost, which includes $2.0 billion of revenue attributable to Vifor over 11 months since the completion of the buyout.

In seven years, the company has more than doubled its sales from $6.1 billion in 2016. And CSL sees the trend continuing as it projects a 9% to 11% increase in revenue in its fiscal year 2024, with profit landing between $2.9 and $3 billion, for a 13% to 17% gain.

CSL Behring—the largest of the company’s three business units—accounted for $9.3 billion of the company’s revenue, a 12% increase, boosted by the increase in plasma. CSL opened 12 new collection sites during the year and whittled collection costs by 14% from the previous fiscal year. Those figures include labor and donor compensation costs.

CSL chalked the increase up to “improved social mobility post-COVID, targeted marketing campaigns and enhanced digital initiatives to attract donors."

With the ability to manufacture more plasma-based products, CSL saw its immunoglobulin (Ig) sales increase 21% to $4.7 billion. In the previous fiscal year—with the pandemic affecting plasma collections—immunoglobulin sales were down 3%. Fueling the growth was Privigen, which posted a 21% increase in sales.

“We've been, as you know, a bit hand to mouth going through COVID. We took a bit of a conservative, but appropriate approach to make sure that patients continue to receive our brands going forward,” Bill Campbell, CSL’s chief commercial officer, said on a conference call “The commercial teams around the world are quite anxious to get after more Ig volume after being a bit restrained in the last couple of years.”

CSL’s two other units, CSL Seqirus and CSL Vifor, each achieved revenue of more than $2 billion, posting growth of 9% and 14% respectively. CSL Seqirus is the company’s vaccine unit and 90% of its sales are from flu shots.

“For CSL Vifor, our focus is on organizing ourselves to unlock the value and growth within this business, a business we are yet to fully leverage,” Paul McKenzie, CSL’s CEO who took over in March, said on the call. “The iron and nephrology markets are evolving, and I have no doubt there will be challenges in the CSL Vifor growth profile, but the unmet patient need within these markets is significant.” 

In November of last year, CSL gained approval from the FDA for its hemophilia B gene therapy Hemgenix and made it the highest-priced drug in the world at $3.5 million. The company said it has dosed its first patient in the U.S.

https://www.fiercepharma.com/pharma/csl-gets-top-line-boost-thanks-post-pandemic-boom-plasma-collections

AstraZeneca hit with FDA warning letter over 'misleading' Breztri efficacy claims

 AstraZeneca’s promotion of Breztri Aerosphere has landed it in hot water with the FDA. The agency says an AstraZeneca sales aid made “misleading” claims about the effect of the inhaler on all-cause mortality, prompting it to send a warning letter to CEO Pascal Soriot.

Following FDA regulations, AstraZeneca sent the sales aid and other Breztri promotional materials to the FDA for review. The agency found fault with the sales aid. According to the FDA, the document includes the “prominent headline claim” about a difference in time to all-cause mortality between the Breztri and control cohorts in a chronic obstructive pulmonary disease (COPD) clinical trial. 

Citing data published in 2020 and 2021, the sales aid claimed a “49% Observed relative difference with BREZTRI vs LAMA/LABA.” The FDA took a dim view of the suggestion that Breztri had a positive impact on all-cause mortality.

“These claims and presentation, in the context of a promotional communication describing the safety and efficacy of Breztri, are misleading because they suggest that Breztri treatment has been shown to have a positive impact on all-cause mortality and reduce the risk of death in COPD patients,” the FDA wrote in its warning letter. “These suggestions are not supported by the cited references.”

A secondary endpoint of one of the cited studies showed “the risk of death (on and off treatment) with BGF 320”—triple therapy with the Breztri active ingredients budesonide, glycopyrrolate and formoterol fumarate—“was 49% lower than that with [glycopyrrolate and formoterol fumarate].” 

However, as the FDA notes in its warning letter, “endpoints higher in the analysis hierarchy” failed, and, as such, “the trial does not allow for any conclusions to be drawn from the [all-cause mortality] data.” The FDA also called out a perceived issue with the trial design, noting that the “abrupt withdrawal of [inhaled corticosteroids] may have been a confounding factor when analyzing any positive effect on [mortality].” 

In the FDA’s view, the “claims and presentation are concerning from a public health perspective because they overstate the efficacy of the drug and misleadingly suggest that Breztri will have a positive impact on [all-cause mortality] and reduce the risk of death in COPD patients.” The warning letter also criticizes the use of a p-value that gives a misleading impression that another outcome was statistically significant. 

The FDA sent the warning letter Aug. 4 but only published it online Aug. 15. AstraZeneca had 15 working days from the date it received the letter to respond in writing with a “plan for discontinuing use of such communications, or for ceasing distribution of Breztri.”

https://www.fiercepharma.com/marketing/astrazeneca-hit-fda-warning-letter-over-misleading-breztri-efficacy-claims

BMJ's editor-in-chief wants action on pharma payments to leading doctor education groups

 A month after The BMJ ran an investigation into payments from the life sciences industry and patient groups to the U.K.’s Academy of Medical Royal Colleges, the journal’s editor-in-chief is calling for these transactions to be made more transparent.

That investigation, published by The BMJ in July, found that royal colleges responsible for doctors’ training got more than 9 million pounds sterling ($11.4 million) in payments from drug and medical device companies going back to 2015.

The BMJ found, however, that these payments were not always being publicly disclosed.

In an open letter, The BMJ’s editor-in-chief Kamran Abbasi wrote: “Transparency is the absolute minimum for managing conflicts of interest,” and “royal colleges shouldn’t rely on industry transparency initiatives which many people agree don’t go far enough.”

Royal colleges should “take the lead and disclose industry funding in a comprehensive and standardised manner,” he added. This is something the Academy of Medical Royal Colleges, the membership body for the medical royal colleges and faculties, could coordinate, he said.

Abbasi said there is clear “evidence [which] shows clinicians’ prescribing habits are influenced by industry marketing” and that informed discussion by their members and the public “about how such payments should be governed and under which conditions they should be received, if at all,” should now be had.

The BMJ's investigation required searching through industry databases to uncover certain payments from drug companies to royal colleges. However, a follow-up editorial noted that "these databases offer only a partial glimpse of the money accepted, why it was paid, and what it was used for."

In May, the Department of Health and Social Care for England announced a public consultation on mandatory disclosure of industry payments to the healthcare sector, similar to the Sunshine Act in the U.S.

https://www.fiercepharma.com/marketing/bmjs-editor-chief-wants-action-pharma-payments-leading-doctor-education-groups-uk