Noninferiority established through high treatment success, low adverse event rates
Findings presented at ESC Congress 2023 and simultaneously published in The New England Journal of Medicine
Sunday, August 27, 2023
BridgeBio: positive results from Phase 3 in transthyretin amyloid cardiomyopathy
The primary endpoint was met (
- Absolute values observed across all-cause mortality (ACM), cardiovascular mortality (CVM) and CVH showed that over 30 months, patients survived more and were hospitalized less than has been seen in prior controlled studies of ATTR-CM to the company’s knowledge
- The 81% survival rate on acoramidis approaches the survival rate in the age-matched US database (~85%)
- The 0.29 mean annual CVH rate on acoramidis approaches the annual hospitalization rate observed in the broader US Medicare population (~0.26)
- Assessment of measures of disease progression in the trial suggest that on acoramidis, 45% of subjects experienced an improvement from baseline in N-terminal prohormone of brain natriuretic peptide (NT-proBNP) versus 9% on placebo, and 40% of subjects experienced an improvement from baseline on 6-minute walk distance (6MWD) versus 24% on placebo; to the company’s knowledge, the proportions of treated patients improving on these measures over 30 months are higher than have been observed in prior controlled studies in ATTR-CM
- Acoramidis achieved near-complete stabilization of transthyretin (TTR) in both wild-type and variant ATTR patients; serum TTR was promptly and consistently elevated throughout the study
- In an exploratory post-hoc analysis of the relationship between on-treatment serum TTR levels and on-treatment measures of CVH, NT-proBNP, and Kansas City Cardiomyopathy Questionnaire (KCCQ), there was an association between the mean on-treatment TTR level and each of these three variables, consistent with the premise that ever-higher degrees of stabilization lead to ever-better outcomes for patients
- As was previously reported, in a comparative exploratory post hoc analysis enabled by tafamidis drop-in, albeit at low patient numbers, acoramidis showed a 42% greater increase in serum TTR levels relative to placebo + tafamidis
- Acoramidis was well-tolerated, with no safety signals of potential clinical concern identified
- Company intends to file a New Drug Application (NDA) with the
China's 'aggressive behaviour' in South China Sea must be challenged - U.S. Navy official
China's "aggressive behaviour" in the South China Sea, including the use of water canon by its coast guard against a Philippine vessel, must be challenged and checked, the commander of the U.S. Navy's Seventh Fleet said on Sunday.
Vice Admiral Karl Thomas assured the Philippines of U.S. backing in the face of "shared challenges" in the region, saying: "My forces are out here for a reason."
The largest of the U.S. Navy's forward-deployed fleets, the Seventh Fleet, headquartered in Japan, operates as many as 70 ships, has around 150 aircraft and more than 27,000 sailors.
It operates over an area of 124 million square km (48 million square miles) from bases in Japan, South Korea and Singapore.
"You have to challenge people I would say operating in a grey zone. When they're taking a little bit more and more and pushing you, you've got to push back, you have to sail and operate," Thomas told Reuters.
"There's really no better example of aggressive behaviour than the activity on 5 August on the shoal," he added.
On Aug. 5, a Chinese coast guard ship used water cannon against a Philippine boat carrying supplies to troops aboard a warship Manila intentionally grounded on a shoal in the South China sea, a fault line in the rivalry between the U.S. and Beijing in the region.
Thomas said he had had discussions with Vice Admiral Alberto Carlos, the head of the Philippine Western Command overseeing the South China Sea, "to understand what his challenges are to find opportunities to be able to help him".
"We certainly shared challenges. So I wanted to better understand how he views the operations that he's responsible for. And I want to make sure that he understood what I had available," said Thomas who was in Manila for a port call.
On Saturday, Thomas said he joined a flight from Manila "to go out and check out the South China Sea".
The Philippines won an international arbitration award against China in 2016, after a tribunal said Beijing's sweeping claim to sovereignty over most of the South China Sea had no legal basis.
China has built militarised, manmade islands in the South China Sea and its claim of historic sovereignty overlaps with the exclusive economic zones of the Philippines, Vietnam, Malaysia, Brunei and Indonesia.
The Chinese Embassy in Manila did not immediately respond to a request for comment.
https://news.yahoo.com/chinas-aggressive-behaviour-south-china-113546379.html
Barbarism in the Name of Equality
The debate about transgender medicine is shifting. Legislators in 20 states have recently passed bills to restrict transgender medical interventions, such as puberty blockers, cross-sex hormones, and genital surgeries, for minors. And the tide of public opinion appears to be moving against “gender-affirming care,” a euphemism for child sex-change procedures not supported by the evidence and that often cause devastating consequences. Preventing such procedures for patients under age 18 has to be the baseline.
But opponents of gender medicine should not celebrate prematurely—the battle is far from won. And while restrictions on such procedures for minors are essential, more scrutiny should be focused on a lesser-known practice: “non-binary” surgeries for adults.
Curtis Crane is one of the doctors leading this movement. Crane is a University of Iowa and Dartmouth College-trained urologist and plastic surgeon who specializes in transgender medical interventions, including experimental non-binary surgeries.
In 2015, Crane received a flurry of publicity as an innovator in vaginoplasty, which involves castrating and creating an artificial vagina for “male-to-female” patients, and phalloplasty, which involves creating and installing an artificial penis for “female-to-male” patients. He boasted of a one- to two-year waitlist and claimed to have one of the highest volumes of transgender surgeries in the United States.
Since then, business has boomed. Crane operates clinics in San Francisco, California, and Austin, Texas, employs a team of five doctors, and conducts procedures on more than 1,000 patients per year. As part of this caseload, his practice has veered into the disturbing new territory of non-binary surgery, which includes castration, eunuch, and nullification procedures, which Crane describes as the process of “removing all external genitalia to create a smooth transition from the abdomen to the groin.” Crane has also designed and performed hundreds of non-binary surgeries in which he fashions together both male and female genitalia for a single individual. That is, he creates an artificial penis for a woman, while retaining her vagina; or creates an artificial vagina for a man, while retaining his penis.
Crane recounted the story of performing his first non-binary genital surgery in a question-and-answer session for potential patients. “In the beginning of my practice, within the first year, I’d say, I had a trans man come to me, and he wanted a phalloplasty, but he wanted to keep his vagina,” Crane recalled. After a process of “soul searching,” he concluded that, if gender was not binary, his surgeries did not need to conform to a typical male-female pattern. “[The patient] wanted to keep his vagina because he got sexual gratification out of having a vagina. And I thought it’s kind of assault to make a patient remove an organ that they’re enjoying. Let’s keep it.”
How are these physically unnecessary surgeries justified? Through the politics of “equality” and “recognition.” Last year, in a keynote speech for the Equality Alliance, Crane laid out his philosophy of transgender medicine. “Our history has been riddled with inequalities,” he said, and the West, in particular, has propped up a false gender binary—that of man and woman—that denies the basic right to recognition of individuals self-identifying as transgender, non-binary, gender-nonconforming, genderqueer, and gender fluid.
Crane proposed two solutions. First, the social-utopian solution: to reeducate all of society to accept that biological sex is not binary—“XX is not always female and XY is not always male”—and “humanize this predicament,” with the end goal of “acceptance” of anti-normative sexual identity. Second, the technical-constructivist solution: to remove, alter, fabricate, and reorganize human genitalia so that transgender patients can “become the people they were always meant to be.”
The doctor’s surgical practice represents the strange metaphysics of transgender medicine, which would like simultaneously to sever the link between sex and biology, erase the primordial distinctions between man and woman, and transcend the limitations of nature through the application of medical technology—all in pursuit of therapeutic, left-liberal notions of authenticity, identity, equality, and acceptance.
There is, however, a dark side to this philosophy. If biology, human nature, and traditional ethics are seen as impediments, rather than as guides, then rational restraints no longer remain on what can be done; the only real limitation is the imagination. And the human mind, untethered from moral limits, can conjure up nightmares. The surgeon, armed with a scalpel and a genital-nullification robot, becomes the new arbiter of human nature.
Crane styles himself as a champion of science and equality, but he more closely resembles Dr. Frankenstein. A reckoning might be coming. In 2018, the feminist writers at 4thWaveNow discovered that a large number of transgender patients had sued Crane for medical malpractice. An anonymous “detransitioner” came forward with accusations that Crane had needlessly removed her breasts while she was a minor. All of the former patients described barbaric surgeries and gruesome complications. The cases were dismissed in court, potentially as the result of settlements.
To stop the radical experiments performed by surgeons such as Crane, society will need to impose limits. Medical associations, which have been captured by gender ideologues, do not seem capable of resisting the temptation of “trans-affirming medicine.” Outside pressure will be needed, including intervention by legislators, to ensure reform within the medical system and to prohibit medically perverse practices, such as the male-female hybrid genitalia procedure.
Human beings, especially those who suffer from serious emotional disturbances, should not be subjected to experiments of this kind. Crane appeals to “equality” to justify deeply inhuman medical practices; he appeals to “acceptance” to justify the rejection of human nature itself. Both appeals are based on a lie. Our society does not have to recognize as equal those ideologies that violate natural law and does not have to accept medical practices that fail to meet the discipline’s most basic test: “First, do no harm.”
U.S. judge cancels hearing on Mexican suit against gun-makers, Mexico says
A U.S. judge has canceled a hearing on a $10 billion lawsuit filed by Mexico seeking to hold U.S. gun manufacturers responsible for facilitating arms trafficking to drug cartels, Mexico's foreign ministry said on Saturday.
The ministry, which has been urging a U.S. appeals court to revive the case, said that the hearing, due to take place on Monday, had been canceled last Thursday.
"The judge assigned to the case, Cindy Jorgenson, issued an order canceling the hearing in which she only stated that she is considering excusing herself from hearing the present litigation," the ministry said.
The judge and U.S. court officials were not immediately available for comment.
Seven in 10 crime guns recovered and traced in Mexico come from the United States, according to U.S. gun control agency ATF. This level nears 80% across the Caribbean, where many countries have backed the Mexican lawsuit.
The Mexican and U.S. governments have recently agreed to boost controls against arms trafficking through an electronic tracking program for weapons seized from criminal groups, but neither has offered details on the plan.
China Cuts Tax on Stock Trading to Boost Market Confidence
China is considering cutting its stamp duty on stock trades in a bid to boost its stock market, according to a report from Bloomberg News. The country has also decided to stop publishing the youth unemployment rate.
Cutting the stamp duty on stock trades in order to boost the world's second largest equity market would really be a boost for Chinese equities if they were to cut that stamp duty. A stamp duty is like a levy on stock trades, and this would be the first time that it's cut since 2008. Now, the stamp duty currently sits at 0.1% on stock trades, and a draft proposal is being considered.
The Chinese equity market is valued at $9.9 trillion, so it's very sensitive when it comes to any type of shift in liquidity. And the stock market really is a barometer of consumer and business confidence. So the government is trying to boost investor confidence, trying to keep capital flowing into the markets.
The Chinese economy and households are going through some major challenges right now. One is being falling property taxes, the other is a weak job market. And you had Chinese equities that had a two-month rally, which then fizzled out. You had loanable funds that were selling into that rally believing that perhaps that whatever the Chinese government was doing in terms of stimulus to shore up the economy wouldn't be enough.
Now, China's stamp duty is on stock. Trading has been adjusted several times. It was adjusted, as I mentioned back in 2008, it was cut to support a market plunge. And in 2007, as you saw a market melt up go-- as the market was rallying, you had investors, China had more than 300,000 new investors entering the market. So they at that point raised the levy in order to sort of cool down that rally.
Biden racks up social media flak for erroneous climate policy post
President Biden was blasted by critics Friday for getting a major point wrong while trying to tout the success of his climate policies.
While trying to brag about the success of his administration, the 80-year-old commander-in-chief incorrectly prophesized that the country would pull most of its power from renewable energy by the end of the year — seven years ahead of the true projection.
“The Inflation Reduction Act is projected to help triple wind power and increase solar power eightfold, while electricity deployed through the U.S. power grid is expected to be powered by 81% clean energy by 2023,” Biden posted to X, formerly known as Twitter.
The tweet — which racked up over two million views — accompanied a picture of Biden posing for a selfie with an unidentified US energy worker.
The gaffe earned him a “community note” pointing out that officials don’t anticipate reaching that goal before 2030.
Under the 730-page Inflation Reduction Act — which the president recently admitted he regrets naming as such — commit $369 billion to environmental projects, including grants to renewable energy companies and tax breaks for consumers over the span of years.
The typo earned the 46th president plenty of ire from critics, many of whom couldn’t pass up the opportunity to critique Biden.
“Joe Biden doesn’t even realize it is currently 2023,” veteran Jesse Sweeney wrote.
“We’re in 2023 already, genius,” conservative user Rich Weinstein joked.
One X account said: “got caught lying again.”
“Joe Biden is a perfect example of the light being on, but no one’s home,” said another.
Former GOP New York US Senate candidate Paul Szypula took aim at Biden’s unnecessary selfie, as well as his administration’s energy policies.
“Biden is taking staged selfies like an egomaniac while he brags about ‘clean energy’ — meanwhile energy prices are through the roof. And there’s nothing clean about solar and wind energy. Their manufacturing creates a lot of pollution. They’re also inconsistent and unreliable,” he wrote.
Daniel Turner, founder of Republican environmentalism group Power the Future, added: “It is 2023. And we’re not at 81%. This makes zero sense so I guess you tweeted it yourself."
https://nypost.com/2023/08/26/biden-blasted-for-erroneous-climate-policy-post/
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