New evidence casts doubt on a much-hyped blood test for early cancer detection

 New evidence published by The BMJ today casts doubt on a much-hyped blood test for the NHS that promises to detect more than 50 types of cancer.

The test, called Galleri, has been hailed as a "ground-breaking and potentially life-saving advance" by its maker, the California biotech company Grail, and the NHS is currently running a trial of the test involving more than 100,000 people in England, report Dr. Margaret McCartney and investigative journalist Deborah Cohen.

NHS England claims the test can identify many cancers that "are difficult to diagnose early"--such as head and neck, ovarian, and pancreatic cancers--and that if it is effective, it could be used in a national screening program.

Trial success would also hand Grail a lucrative deal with the NHS, which--if results are favorable--has agreed to buy millions of tests in exchange for a new state-of-the-art facility built by Grail in the UK. Although contract details remain confidential, a single test in the U.S. currently retails for $950.

But documents leaked to The BMJ suggest that the trial is not suitable to justify a national screening test, while experts believe that Galleri has been over-hyped and that the current trial is unethical.

Even the chair of the UK National Screening Committee has privately voiced "serious concerns" to NHS England's chief executive about the trial, according to email messages seen by The BMJ.

Interim results of the trial have not been published as expected this month. Instead, NHS England said the results were not "compelling enough" and a decision to roll out the test will wait until final trial results in 2026.

But as the trial continues, Freedom of Information requests by The BMJ raise further concerns over the close relationship between key government figures and Grail, including meetings with ex-prime minister Lord Cameron and Nadhim Zahawi, then minister in the Department for Business, Energy and Industrial Strategy.

An NHS England spokesperson said they believed that Grail was "now being subjected to one of the largest and most rigorous investigations done in any health-care system worldwide," that no decision had been made, and no further details were available.

By contrast, an NHS England source, speaking to The BMJ anonymously, said "The clinical or scientific data doesn't stack up, but that should have come first. This is not the way to do a trial—it should be done transparently. It's not been thought through at all."

Added to these concerns, Grail is facing a class action lawsuit in the US. Embittered investors, faced with steep losses, claim the company exaggerated Galleri's effectiveness in order to increase share price.

Richard Sullivan, director of the Institute of Cancer Policy, King's College London, says that Grail is "a clear-cut case of public risk and private profit."

Concerns surrounding the decision making process around Grail also serve as a timely reminder to the new Health Secretary, Wes Streeting, whose stated aim is to make the UK a "life sciences and medical technology powerhouse," note McCartney and Cohen.

"The new government needs a more rigorous and transparent way of reviewing medtech clinical research, especially when it involves such widespread access to NHS resources," adds Sullivan. "They also need to change their language. It's all promissory science and hype. This serves no public good whatsoever."

More information: The holy grail of blood tests? New evidence casts doubt on a much-hyped screening tool, The BMJ (2024). DOI: 10.1136/bmj.q1706

https://medicalxpress.com/news/2024-08-evidence-hyped-blood-early-cancer.html

Some e-cigarette chemicals mimic nicotine, possibly bypassing regulation

 In what appears to be an effort to bypass public health regulations covering vaping products, some tobacco companies have begun replacing nicotine in e-cigarettes with related chemicals that have similar properties but unknown health effects, Duke Health researchers report.

In a research letter appearing Aug. 7 in JAMA, study authors at Duke and Yale University also found that the quantity of these chemicals, known as nicotine analogs, are not accurately disclosed on the packaging.

"Vaping products containing nicotine are subject to federal laws that prohibit sales to people under the age of 21," said study co-author Sairam V. Jabba, D.V.M., Ph.D., a senior research scientist at Duke University School of Medicine.

"Nicotine analogs are currently not subject to the FDA process and have not been studied for their health effects," Jabba said.

"Our analysis of some of these analog-containing vaping products sold in the U.S. found significant and concerning inaccuracies in the ingredients these products claim to contain and what they actually contain. Further, it's possible manufacturers are attempting to avoid FDA tobacco regulation."

One chemical, known as 6-methyl nicotine, has been shown in rodent experiments to be far more potent than nicotine in targeting the brain's nicotine receptors and more toxic than nicotine. Another, called nicotinamide, is marketed as targeting the same brain receptors as nicotine, despite evidence it does not bind to these receptors.

The nicotine analogs were included in flavored e-cigarettes, which prior research has indicated are preferred by youths and those who vape for the first time.

Jabba and colleagues, including co-senior author Sven Eric Jordt, Ph.D., analyzed an e-cigarette product sold under the brand name Spree Bar, which comes in at least nine flavors and is listed as containing 5% 6-methyl nicotine. Study results showed the actual amount of the chemical was about 88% less than labeled.

The e-cigarettes also included an artificial sweetener that is up to 13,000 times sweeter than table sugar, and an artificial coolant that mimics menthol's effects.

A second brand of e-cigarettes—marketed as Nixotine, Nixodine, Nixamide and Nic-Safe—contained a nicotine analog called nicotinamide, also at levels lower than the labels indicated, and combined with undisclosed amounts of 6-methyl nicotine. This brand did not include sweeteners or coolants.

"These products appear to be designed to circumvent the laws and regulations in place to protect people—especially children—from the harmful effects of smoking and tobacco use," Jordt said.

"We do not know what these chemicals do when they are heated and inhaled. These are questions that should be answered before we allow products on the market."

More information: Variability in Constituents of E-Cigarette Products Containing Nicotine Analogues, JAMA (2024). jamanetwork.com/journals/jama/ … 1001/jama.2024.12408

https://medicalxpress.com/news/2024-08-cigarette-chemicals-mimic-nicotine-possibly.html

Keto diet study shows higher LDL cholesterol, apolipoprotein B, less gut bacteria

 A team of health and nutrition specialists at the University of Bath, working with colleagues from the University of Bristol, the Oxford University Hospital Trusts, Maastricht University, and the Teagasc Food Research Center, has found that people on a ketogenic diet may experience an increase in LDL cholesterol levels, higher apolipoprotein B levels and reductions in certain gut bacteria.

In their study, published on the open-access site Cell Reports Medicine, volunteers went on a ketogenic diet for a month so the researchers could study its impact on their bodies.

A ketogenic diet consists of a drastic reduction in consumption of carbohydrates, replacing them with fats from meat, dairy, cheese, eggs and other foods such as avocados. Prior research has shown that those adhering to the rules do lose weight, but also that the diet may cause other health problems such as nutrition deficiencies, digestive problems, kidney stones and, over the long term, bone problems.

In this new effort, the research team suspected that the diet may also lead to increases in LDL cholesterol levels and possibly other problems. To find out if that might be the case, they conducted a randomized controlled trial by recruiting volunteers to go on the diet for a month and then to undergo a medical evaluation to determine changes.

The trial involved 53 non-obese adults. A third of them went on a ketogenic diet, another third went on a low-sugar diet and the remaining third ate what the researchers describe as a moderate diet to serve as a control.

After one month, all the volunteers were tested. The research team found that those volunteers on the ketogenic diet had lost on average 1.6 kg of fat. They also had 16% higher levels of LDL cholesterol in their blood than the control group and 26% higher levels of apolipoprotein B, a protein known to clog arteries. Those on the low-sugar diet lost on average of 1 kg of fat and had 10% lower levels of LDL cholesterol in their blood samples and no change in apolipoprotein B levels.

The researchers noted that those volunteers who had been on the ketogenic diet also had reduced levels of a type of gut bacteria known to be involved in promoting a strong immune system and also in the production of vitamin B.

More information: Aaron Hengist et al, Ketogenic diet but not free-sugar restriction alters glucose tolerance, lipid metabolism, peripheral tissue phenotype, and gut microbiome: RCT, Cell Reports Medicine (2024). DOI: 10.1016/j.xcrm.2024.101667

https://medicalxpress.com/news/2024-08-keto-diet-ldl-cholesterol-higher.html

Xenophile Tim Walz says we Americans ‘owe’ the illegal migrants a ‘debt of gratitude’

 Neil Munro, writing for Breitbart News, reported that in 2021, Kamala Harris’s new running mate penned a letter to the Democrat leadership in Congress, declaring that we Americans “owe” the illegal invaders living in our nation a  “debt of gratitude.”

Apparently to Tim Walz, if you violate American sovereignty, flagrantly and arrogantly disrespect American law and order, steal from and leech off of the American people, rape and murder American children, and bring in and promote cultures that are vastly inferior to the traditional Judeo-Christian culture of American heritage, it’s you who deserves tremendous thanks, not the citizenry that has long-suffered all the chaos and dysfunction.

Walz made the argument as he petitioned for lawmakers to make a “pathway” for citizenship, because obviously the criminals should be rewarded for their “contributions” to society—not.

Here’s Walz’s letter:

 

 

He should definitely be our next vice president—not.

Munro also highlighted more of Walz’s xenophilia/Ameriphobia here:

He [Walz] championed migrants as a moral and business cause in his 2022 election, claiming that his more cautious GOP rival ‘is 100 percent wrong morally, and he’s 100 percent wrong economically and culturally.’

He wrote in a 2019 letter to President Donald Trump’s Secretary of State:

‘Refugees strengthen our communities. Bringing new cultures and fresh perspectives, they contribute to the social fabric of our state. Opening businesses and supporting existing ones, they are critical to the success of our economy. Refugees are doctors and bus drivers. They are entrepreneurs and police officers. They are students and teachers. They are our neighbors.’

…

Immigration ‘is the fabric of our life,’ Walz told a talk radio show during his 2022 re-election campaign. ‘It’s proven by the data that we know that the community pays in and gives far more back than they take out,” he insisted, after accepting 1,200 Afghan migrants.

…

In March 2023, Walz signed a law allowing illegals to drive cars, so helping illegals compete for wages that otherwise would go to Minnesotans. ‘As a longtime supporter of this bill, I am proud to finally sign it into law, making our roads safer and moving us toward our goal of making Minnesota the best state to raise a family for everyone,’ he said.

First of all, no, refugees are not paying in more than they take out—but especially not the ones from Afghanistan. Afghan migrants are notorious for being the most barbaric and detrimental—they come from a culture that widely practices bacha bazi—and one need only read Dr. Cheryl Benard’s groundbreaking report on that for the details and data. (As a whole, Americans spend hundreds of billions of dollars a year on the migrants by way of welfare and public handouts.)

And, just yesterday I wrote a blog on the welfare numbers for certain migrant demographics, among which included Afghan refugees—around half of them are on the German dole, and a “vast majority” are on special asylum benefits.

To another one of Walz’s points. Sure, legal, restricted, and merit-based immigration is indeed a benefit to a host nation, but that’s not what the powers that be are giving us; we’re getting the literal scum of the earth: foreign nationals conducting terrorist test runs; thugs who rape and murder female joggers; pedophiles who lure little girls under bridges before torturing, raping, and strangling them; communist spies working for enemy nations; cartels and all their organized crime, including drug- and human-trafficking; Sharia colonizers and jihadists; and severely disturbed mental patients as the South American nations have been emptying their asylums and prisons, lifting their state financial burden and placing it on us.

But not only are we getting the worst of the worst, politicians like Walz are bleeding us dry to provide extremely generous “benefits” to these “newcomers.”

Only a progressive Democrat would argue that inferior cultures, rape, and murder are something for which to be thankful, and sure, Walz intends to welcome even more of it into the nation if he breezes into the federal executive, but have you considered that Kamala is “black” and a “woman”? Let’s vote for what matters here, which is obviously skin color and sex, not policy—just kidding, I’m not a Democrat.

https://www.americanthinker.com/blog/2024/08/xenophile_tim_walz_says_we_americans_owe_the_illegal_migrants_a_debt_of_gratitude.html

Why is Maduro so interested in Venezuela's 'Tren de Aragua' gang activity in U.S.?

 By Monica Showalter

Venezuela's democratic forces are a pretty observant lot, having spotted evidence of fraud in some background pictures of the regime's vote-counting houses as employees took selfies.

Now, one of them has spotted something interesting on dictator Nicolas Maduro's cell phone as he made a televised speech, in a whatsapp message from one of his closest lieutenants:

 

 

Arreaza is Hugo Chavez's son-in-law, and a trusted Chavista confidante, having held positions such as foreign minister, minister of science and technology, and vice president. During Chavez's final illness at the hands of Castrocare, he served as the unofficial spokesman for the Chavez family.

He's almost certainly a fluent English speaker, having gotten his master's degree in European Policy Studies at Cambridge University, in the U.K.

He's also one of those guys who got himself sanctioned, during the Trump administration, cutting off his access to U.S. banking.

According to Wikimedia Commons:

The U.S. Department of State issued a statement describing Arreaza as being "at the forefront" of the Maduro administration attempts "to thwart the democratic aspirations of the Venezuelan people."[

Now we learn that he's sending whatsapp messages to Maduro himself with articles about Tren de Aragua's progress wreaking mayhem in the United States.

It's been reported that Maduro emptied his prisons, specifically Tocoron prison which is or has been controlled by Tren de Aragua gangs, to fire up the border surge against the U.S., telling released thugs to head north. Tocoron was recently taken over by the Venezuelan government, and many believe deals were cut, though the Venezuelan government denies it.

It's also known that the late Hugo Chavez himself took an intense interest in pushing illegal immigration to the border, once saying he'd be glad to camp out there to help the illegals in.

It's further known that Maduro's close ally, the odious Marxist dictator Daniel Ortega, has a complete border surge operation going on, flying illegal migrants in from as far away as India, collecting his fees, and sending them north, specifically to wreak havoc onto the U.S. as he said so himself.

According to CNN, Tren de Aragua is doing this in the states:

An alleged multistate human trafficking ring forcing immigrant women into prostitution. The mysterious killing of a former police officer in South Florida. Attacks against police officers in New York. The arrest of a drug dealer in Chicago.

Local and federal officials say these apparently unrelated crimes have a common denominator: Tren de Aragua, a transnational criminal gang that originated in a Venezuela prison and has slowly made its way south and north in recent years. They say it’s now operating in the United States. The scale of its operations is unknown, but crimes attributed to alleged members of the gang have worried elected officials and some Republican members of Congress have asked the Biden administration “to formally designate the vicious Tren de Aragua as a Transnational Criminal Organization.”

For several years, the criminal group has terrorized South American countries, including Venezuela, its country of origin, as well as Bolivia, Colombia, Chile and Peru. Retired general Óscar Naranjo, a former vice president of Colombia and chief of the Colombian National Police, told CNN Tren de Aragua is “the most disruptive criminal organization operating nowadays in Latin America, a true challenge for the region.”

Three days ago, the U.S. did designate it a transnational criminal organization. CNN noted in its report that it's been mentioned in connection with at least 70 crimes committed in U.S. charges, with many more merely suspected.

Now we learn that Maduro is abnormally interested in this, in news stories about its activities.

If Maduro has a hand in this game, he needs to answer for it. If the border surge is all about sending gangs into the U.S. and actually directing these dirtbags to murder our nationals, (as the brother at least of one member is accused of doing on a Georgia nursing student), and many other crimes, then we are looking at an act of war, that would actually justify a hoseout of that hellhole which is currently in an election fraud debacle. If the Harris-Biden team refuses to act on it, they're just letting it happen because they're happy it's happening. The rest of us should read this as a more serious invasion than anyone suspected.

https://www.americanthinker.com/blog/2024/08/why_is_venezuela_s_maduro_so_interested_in_venezuela_s_tren_de_aragua_gang_activity_in_the_u_s.html 

Does Headache Surgery Really Work? Neurologists Remain Unconvinced

 Jeffrey E. Janis, MD, is on a mission. The professor of plastic surgery, surgery, neurosurgery, and neurology at The Ohio State University Wexner Medical Center, Columbus, Ohio, wants to convince neurologists of the safety and efficacy of nerve decompression surgery for treatment-resistant headache. However, many neurologists remain unconvinced.

"Headache surgery is a viable alternative for complex patients who have failed medical management and who could benefit from this treatment approach. There's 24 years of evidence behind this surgical technique across hundreds of different studies with different study designs," Janis told Medscape Medical News. 

Yet this treatment approach — surgery on peripheral nerves rather than the brain or spinal cord — hasn't garnered much support from neurologists. A scan of the agenda of topics at the recently held at the American Headache Society 2024 Annual Meeting showed few if any studies or presentations on this topic. And neurologists Medscape Medical News spoke to said they believe the surgery is experimental and unproven.

Experts do agree drugs don't work for all patients with migraines. Up to 30% of patients don't respond to the "laundry list of medications" available to treat the condition, said Janis.

Many patients have also tried, and failed, alternative treatment approaches such as massage, acupuncture, craniosacral therapy, transdermal patches, electrical stimulation, cryoablation, neurostimulation, and radiofrequency ablation.

If nothing else works, is surgery for headaches the answer?

Long-Held Theory

The idea that pinched, irritated, or compressed peripheral nerves can trigger migraine attacks has been around for nearly 25 years. Studies suggest that in addition to migraine, nerve compression can lead to other headache conditions, including occipital neuralgia, supraorbital neuralgia , and posttraumatic headaches.

This has led to the development of surgical techniques to deactivate various compression trigger sites — what Janis calls "pinch points" — which could involve muscles, bone, fascia, blood vessels, or scar tissue from prior trauma or surgery.

The procedure is predominantly performed by plastic surgeons, but to a lesser degree by neurosurgeons and ear, nose, and throat specialists.

Target nerves in surgical interventions include those in the frontal region of the head above the eye, temporal region, neck region, and nasal region. Affected areas are usually identified either through patient self-reports or by using a nerve block agent such as lidocaine or Botox at specific points, Janis noted. If pain subsides after an injection, that location is marked as a target.

One of the barriers to referring complicated patients for surgery is that neurologists evaluating migraine treatments "speak a different language" than surgeons performing the procedure, said Janis.

Neurologists tend to focus on reduction in monthly migraine days (MMD), while surgeons typically use the Migraine Headache Index that incorporates the frequency, intensity, and duration of migraine attacks.

"Rather than try to convince somebody to speak a different language, we thought, why don't we just learn their language so we can build bridges and take down barriers," said Janis, coauthor of a systematic review and meta-analysis published online recently in Plastic and Reconstructive Surgery.

Investigators examined 19 studies in the review, including five randomized controlled trials (RCTs), published from January 2020 to September 2023, with a total of 1603 participants who were mostly female and ranged in age from 9 to 72 years. Study follow-ups extended from 6 to 38 months. All but three studies were carried out in the United States, and six different compression sites were addressed during surgery.

Investigators found that across studies and by a number of measures, migraine frequency and severity improved after surgery.

MMD decreased by 36%-92% and the number of overall migraine attacks per month dropped 25%-87.5%. Patients also reported decreases in attack duration of 41%-75% and intensity of 28%-82% across studies.

"Even using the neurologist-standard language of monthly migraine days, this surgery works," said Janis. "Now this is documented both in the surgical literature and the nonsurgical literature."

The most common complications were ecchymosis, hair loss or thinning, itching, dryness, and rhinorrhea, all of which Janis described as "fairly minor." Major complications such as intraoperative bleeding and wound dehiscence were rare, occurring in 1% or less of participants.

'One And Done?'

These surgeries are usually done on an outpatient basis and generally offer long-term results, Janis said.

"The idea is one and done," he said. "The literature around this type of surgery says that whatever type of effect you get at 1 year is likely to be permanent."

The American Society of Plastic Surgeons agrees. A 2018 position paper developed by experts and commissioned by the society reports that the intervention is safe and effective for appropriate patients, based on a comprehensive literature search and review of a large body of peer-reviewed scientific evidence.

"There is substantial, extensively replicated clinical data that demonstrates a significant reduction in MH [migraine headache] symptoms and frequency (even complete elimination of headache pain) following trigger site surgery," the authors noted.

Pamela Blake, MD, a neurologist, board-certified headache specialist, and medical director at the Headache Center of River Oaks, Houston, is a proponent of what she said can be "lifesaving" headache surgery.

"If a doctor told you that you can either treat this problem with medications that you'll need to take for the rest of your life or you can have a surgical procedure as an outpatient that has extremely low risk and has, in my experience, a 75% chance of reducing or eliminating your pain, you probably would be interested in surgery," she told Medscape Medical News.

Continued Skepticism

However, other neurologists and clinicians appear doubtful about this intervention, including Hans-Christoph Diener, MD, PhD, professor of neurology and director, Essen Headache Centre, University of Duisburg-Essen in Germany.

During a debate on the topic a decade ago at the International Headache Congress, Diener argued that, as migraine is a complex multigene-related disorder of the brain, it doesn't make sense that surgery would affect the epigenetics of 22 different genes.

Recently, he told Medscape Medical News that his views have not changed.

The topic remains controversial, and some neurologists are uncomfortable even openly discussing the procedure. Two clinicians who previously commented on this article later asked not to be included.

One neurologist, who asked to remain anonymous, told Medscape Medical News that Janis's review article is "merely a review collecting 19 studies over the previous 10 plus years."

Other limitations cited by this neurologist are the lack of consistency in procedures among the various studies and the inclusion of only four RCTs, the most recent of which was published 8 years ago, suggesting "the study was probably done closer to 9 or 10 years ago," the neurologist said.

Blake suggested some neurologists' reluctance could be due to limited background on the procedure, which she said isn't widely discussed at headache meetings and is covered mostly in plastic surgery journals, not neurology literature. Access to surgery is further limited by a lack of specialists who perform the procedure and inconsistent insurance coverage.

A closer collaboration between neurologists and surgeons who perform the procedure could benefit patients, Blake noted.

"The headache doctor's role is to identify who's a candidate for surgery, who meets the criteria for nerve compression, and then follow that patient postoperatively, managing their medications, although usually we get them off their medications," she added.

From Janis' perspective, things are starting to change.

"I'm definitely seeing a greater comfort level among neurologists who are understanding where this sits in the algorithm for treatment, especially for complicated patients," he said.

Janis receives royalties from Thieme and Springer Publishing. Blake reported no relevant conflicts. Diener received research support from the German Research Council; serves on the editorial boards of Cephalalgia, Lancet Neurology, and Drugs; and has received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from AbbVie, Lilly, Lundbeck, Novartis, Pfizer, Teva, Weber & Weber, and WebMD.

https://www.medscape.com/viewarticle/does-headache-surgery-really-work-neurologists-remain-2024a1000eif

NASA Head Considers Elon Musk's SpaceX To Save Stranded Boeing Starliner Crew At ISS

 On Wednesday, Steve Stich, NASA's commercial crew program manager, informed reporters that mission control still needs to confirm a return date for the crew of the stranded Boeing Starliner spacecraft at the International Space Station. He mentioned that officials are carefully considering their options, including using SpaceX's Crew-9 Dragon to rescue the two astronauts. 

"Our primary option is to return Butch and Sunny on Starliner. However, we have done the requisite planning to ensure we have other options open. We have been working with SpaceX to ensure they are ready to respond with Crew-9 as a contingency," Stich told reporters. 

The two astronauts, Butch Wilmore and Suni Williams, were initially supposed to spend just a few days on the ISS. That has since turned to two months and could stretch to eight months, with a possible return date in February 2025, according to News Week. 

Stich pointed out, "We have not formally committed to this path, but we wanted to ensure we had all that flexibility in place."

The big story here is that, after two months, Boeing has yet to publicly ask Elon Musk's SpaceX for help. Optically, this would be a significant blow to Boeing's image, especially considering the series of mid-air mishaps involving its 737Max commercial jets. Additionally, it's an election year for the Biden administration, which has been on a crusade against Trump and his supporters, but also is very anti-Musk. Any rescue mission by SpaceX's Dragon spacecraft is undesirable news flow for Democrats.

Last Saturday, we cited a report from Ars Technica, which said there was a "greater than a 50-50 chance that the crew would come back on Dragon." 

Meanwhile, the stranded Starliner spacecraft has created a logjam on the ISS, delaying SpaceX's planned Crew-9 mission, which has been pushed from Aug. 18 to no earlier than Sept. 24, "allows more time for mission managers to finalize return planning for the agency's Boeing Crew Flight Test," NASA wrote in a blog update. 

Imagine that... Trump's wealthiest supporter could save the day on the ISS. 

https://www.zerohedge.com/technology/nasa-head-considers-elon-musks-spacex-save-stranded-boeing-starliner-crew-iss