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Friday, July 5, 2024

Can Oligonucleotide Infusions Really Fix Lyme, Cancer, and Other Diseases?

Clinics across the U.S. are claiming to treat cancer, Lyme disease, and other bacterial and viral infections with "supportive oligonucleotide therapy (SOT)" -- a treatment lacking both data and FDA approval.

The name piggybacks off the success of more than a dozen oligonucleotide therapiesopens in a new tab or window approved by the FDA over the last quarter-century, including treatments for Duchenne muscular dystrophy, spinal muscular atrophy, and other rare diseases.

Many of the clinics are run by physicians or nurse practitioners, but some also have ties to naturopathic doctors. They lure patients with the promise of personalized treatment for difficult-to-fix conditions.

"Once this is in your body, it's almost magical," Connie Casebolt, MD, MPH,opens in a new tab or window said in a YouTube video posted by Forum Healthopens in a new tab or window, a network of integrative medicine clinics. "It can actually cause existing viruses and bacteria and Lyme organisms to die. It also prevents replication. So it's just a really great remedy, and we're seeing some really great results."

But there's no evidence that SOT works, save for two small and limited papers published by the Greek research team that appears to be the key supplier of tailor-made SOTs to U.S. clinics.

Mark Kay, MD, PhD, professor of genetics and pediatrics at Stanford University in California, said it sounded like a "scam."

"It really upsets me when I see this, because these things aren't benign. They do cause side effects," Kay told MedPage Today. "If you treat enough people, someone may have irreversible problems at some point, and none of this is doing any good."

What Is SOT?

Oligonucleotides are short strands of DNA or RNA that can play a role in the regulation of gene expression. Two main types of oligonucleotide drugs on the U.S. market are antisense oligonucleotides (ASOs) and short interfering RNAs (siRNAs).

Essentially, ASOs and siRNAs work by binding to much larger messenger RNA to regulate gene expression and ultimately manipulate the production of proteins, whether to increase them or shut them off.

FDA-approved ASOs include mipomersen (Kynamro) for homozygous familial hypercholesterolemia; eteplirsen (Exondys 51), golodirsen (Vyondys 53), viltolarsen (Viltepso), and casimersen (Amondys 45) for Duchenne muscular dystrophy; and nusinersen (Spinraza) for spinal muscular atrophy. siRNAs include patisiran (Onpattro) and inotersen (Tegsedi) for hereditary transthyretin amyloidosis.

Each of those compounds went through clinical trials and received FDA approval, unlike the SOT treatments being pitched by U.S. clinics.

In her video, Casebolt describes how patients first have a blood test to determine which pathogens they have, and then a blood sample is sent to the lab in Greece, which prepares the SOT based on those microbes. The tailor-made oligonucleotides then reportedly target bacterial genes involved in replication.

Casebolt says the "overall effects can be astonishing," and cited the case of a patient with Parkinson's disease who, after treatment with SOT, could play the violin again for the first time in 6 years.

Clayton Bell, MD, who works at a Forum Health clinic in Asheville, North Carolina, told MedPage Today that he has taken 10 SOT treatments for symptoms of tick-borne bacterial infections, and believes it has helped him.

He said he understands that clinicians may be "skeptical" because the treatments don't have "robust, clinical, double-blind, placebo-controlled trials" behind them; nor do they have FDA approval (though he said they don't need FDA approval because they're regulated as human cellular and tissue-based products, "like a PRP [platelet rich plasma] or like a stem cell").

"I've found it clinically to work. Not every time, but no medicine does," he said. "But when you use it judiciously, in the correct context with the right patient and the right support, I have found it to be very effective in a high percentage of cases."

Most of these clinics cite the Research Genetic Cancer Center (RGCC), based in Greece, as the place where the SOT is made and then shipped back to the U.S. for intravenous infusion.

Made in Greece

Ioannis Papasotiriou, MD, PhD, is the founder of RGCC, which advertises "personalized cancer testing" on its websiteopens in a new tab or window.

Papasotiriou is the corresponding author on the only two papers on SOT found in PubMed. The first, published in March 2022opens in a new tab or window, is a preliminary study in 95 patients with cancer who received SOT. It reports that the majority of patients had a "positive" response to treatment, based on a composite of follow-up assessments for tumor response, but there was no control group.

The second paperopens in a new tab or window, published in December 2022, concluded that SOT reduced the amount of DNA of Borrelia burgdorferi, a bacteria that causes Lyme disease, and other viruses in the blood of 115 patients.

It's not clear exactly what type of oligonucleotide is made for the therapy. The Lyme disease trial describes a siRNA, while an RGCC patient guideopens in a new tab or window describes an "antisense therapy."

RGCC has not returned a MedPage Today request for comment as of press time.

"We don't even know exactly what they're making," said Kay of Stanford. "siRNAs are different from ASOs but can accomplish some of the same things. They can knock down a gene product that you want to knock down."

However, it's not clear that either technology would work in bacterial cells. "As far as I know, there hasn't been any success in treating infectious diseases" like Lyme disease, Kay said. "Molecules would have to get into the bacterial cells to kill them, because you're targeting bacterial genes. As far as I know, this hasn't been accomplished yet."

Also, delivery has long been a challenge with oligonucleotides, which can be rapidly destroyed by the immune system, Kay said. They may be eliminated before they can get where they need to go.

Finally, he added, "if this was so simple, I think companies would have jumped on this to do appropriate preclinical and clinical trials."

Subject to FDA Regulation?

Paul Knoepfler, PhD, a stem cell biologist at the University of California Davis, who blogs about stem cellsopens in a new tab or window, sees parallelsopens in a new tab or window between the clinics giving patients SOTs and the stem cell clinics that the FDA has long been trying to regulate.

Stem cell products given out at clinics across the country have been linked to infectionsopens in a new tab or window and severe adverse events, including hospitalizationsopens in a new tab or window. In 2021, the FDA mandated that all such treatments would need to be regulated as drug products -- not as human cellular and tissue-based products as they had long claimed -- or would require an investigational new drug (IND) application to be in place before being given to patients.

Yet many products continue to be sold, unregulatedopens in a new tab or window and without substantial clinical trial evidence to support them.

"I'm especially concerned about the cancer side of this as I don't see any good evidence to support that SOT would work for cancers and there could be many risks," Knoepfler told MedPage Today in an email. He pointed to an RGCC patient guideopens in a new tab or window that "instructs cancer patients to stop taking some drugs like cytotoxic therapies, which are traditional cancer therapies, a pause that could pose risks."

Knoepfler believes that any oligonucleotide therapy -- even one that may be based on a patient's own blood samples -- would need to be regulated as a drug product by the FDA.

The agency has not returned a MedPage Today request for comment as of press time.

"Just because the FDA has approved a few other specific antisense or other related therapies doesn't mean that SOT would get approval," Knoepfler wrote on his blogopens in a new tab or window. "It would depend on the data."

https://www.medpagetoday.com/special-reports/exclusives/110966

Russia Holds Mobile Nuclear Missile Launcher Drills Days Before NATO Summit In DC

Russia's Defense Ministry (MoD) announced Friday that its forces are in the midst of nuclear drills utilizing Yars mobile nuclear launchers, coming a mere weeks after holding tactical nuclear weapons deployment exercises in southern regions near Ukraine, and in coordination with ally Belarus.

As cited in Interfax and then Reuters, the ministry said that "Yars missile launcher crews in at least two different regions were set to move over 100 kilometres (62 miles) and practice camouflage and deployment."

"Similar exercises will be held by other missile units in the near future," the defence ministry added.

Video issued by the military showed a mobile launcher traveling along forest roads and getting into position before being covered with camouflage to conceal the location.

During the earlier tactical nuke drills held in late May, the MoD had specified that they were necessary in "response to provocative statements and threats by certain Western officials."

Some US and UK officials have lately been pressing for more Ukrainian attacks directly on Russian soil, with Washington officials openly saying they have greenlighted pro-Kiev forces to utilize US-supplied missiles to attack inside Russian territory.

Another among the 'threats' emanating from the West is the possibility of deploying NATO troops in Ukraine. The idea has gained steam ever since Frances Emmanuel Macron first proposed early this year at a security conference in Paris.

These newest drills with mobile nuclear launchers also constitute a bit of fresh nuclear saber-rattling ahead of next week's major annual NATO summit to be held in Washington D.C. (July 9-11).

A central topic of discussion among NATO heads of state will likely be the very issue which marks a red line issue for Moscow - the entry of Ukraine into NATO.

While it's not actually expected to happen anytime soon, the US has vowed to create a "bridge" or clear path to eventual full membership.

However, dozens of foreign policy experts have newly warned of the obvious in a letter published by Politico. "The closer NATO comes to promising that Ukraine will join the alliance once the war ends, the greater the incentive for Russia to keep fighting the war," reads the letter. "The challenges Russia poses can be managed without bringing Ukraine into NATO."

https://www.zerohedge.com/geopolitical/russia-holds-mobile-nuclear-missile-launcher-drills-days-nato-summit-dc

"It's Just My Brain": Biden Defends Health As Dem. Governors Call For Resignation

by Ken Silva via Headline USA,

The New York Times published a bombshell scoop Thursday, signaling the end is near for President Joe Biden as an increasing number of Democrats are abandoning ship.

The Times’s Thursday piece detailed a meeting Biden had with Democratic governors, where he told them he needs to get more sleep and work fewer hours, including curtailing events after 8 p.m.

“He described his extensive foreign travel in the weeks before the debate, something that the White House and his allies have in recent days cited as the reason for his halting performance during the debate,” the Times reported, citing unnamed sources who were in the meeting.

“Initially, Mr. Biden’s campaign blamed a cold, putting out word about midway through the debate amid a series of social media posts questioning why Mr. Biden was struggling.”

Perhaps the most shocking part of the article was Biden’s defense of his health. He reportedly told the governors that “it’s just my brain.” Some governors reportedly took the comment as a joke, but others weren’t so sure.

Either way, Biden apparently didn’t convince the governors that he should still be running.

“Multiple governors who participated in the meeting expressed dismay afterward that there had been little debate about whether Mr. Biden should continue his 2024 presidential campaign,” the Times reported.

Colorado Gov. Jared Polis, for example, reportedly told Biden in the meeting that he’s received a groundswell of wishes from various people that Biden would end his campaign.

Maine and New Mexico’s governors also voiced concerns.

“Ms. Mills said that people didn’t think Mr. Biden was up to running, and Ms. Lujan Grisham said she was worried that the president could lose her state,” the Times added.

Despite all that negative feedback, Biden seems intent on remaining in the race.

“The fact that Mr. Biden began the conversation with the governors by declaring that he was continuing on left some participants feeling that any further discussion about the state of play was chilled,” the Times reported.

https://www.zerohedge.com/political/its-just-my-brain-biden-defends-health-dem-governors-call-resignation

NEA staff goes on strike; Biden cancels speech before group

The National Education Association Staff Organizations (NEASO) announced Friday it is going on strike, prompting President Biden to cancel a planned speech before the NEA’s convention.

The NEASO said they were on a Unfair Labor Practice (ULP) strike against the NEA headquarters in Washington, D.C., filing two ULP complaints with the National Labor Relations Board.

The group alleges the country’s largest teachers’ union has not bargained over unilateral changes, accusing the NEA of wage theft and failing to provide information regarding outsourcing $50 million to contractors.

“The National Education Association has threatened to host its convention virtually to avoid a physical picket line. For a union to trick its members into crossing a picket line is reprehensible. It also confirms what we have been saying: NEA has abandoned its union values with its actions at the bargaining table,” said NEASO President Robin McLean.

“NEA would rather cancel a multi-million-dollar convention than comply with labor law. NEA members should question where their hard-earned dues dollars are being used — and wasted,” McLean added.

The strike will last for two days at the Pennsylvania Convention Center in Philadelphia.

In response to the news, Biden’s reelection campaign announced he would no longer be addressing the NEA on Sunday.

“President Biden is a fierce supporter of unions and he won’t cross a picket line. The President is still planning to travel to Pennsylvania this weekend, and we will have more details to share at a later point,” the campaign said in a statement.

Biden has repeatedly referred to himself as the most pro-labor president in history and in September he became the first sitting commander in chief to join a picket line, marching with autoworkers in Belleville, Mich.

The Hill has reached out to the NEA for comment.

https://thehill.com/homenews/education/4756332-nea-strike-biden-philadelphia/

Don’t trust the lies on diversity, equity, and inclusion in medicine

President Biden’s health has become a central issue, not least because many feel that the Democratic leaders misled the country on his vigor. I feel a similar sense of betrayal by those same leaders who advocate for the supposed beneficial effects of diversity, equity and inclusion or DEI in medicine.

The field of medicine has always been held to be the most trustworthy profession of all. Physicians are supposed to be the hardest working, most skilled and diligent caretakers of our health. Yet the DEI movement is drawing ideological lines in an environment that should be apolitical, eroding trust along the way.

In March, I introduced the EDUCATE Act to ban identity-based mandates at medical schools and accrediting institutions. Since its introduction, there has been a significant propaganda campaign by DEI apologists and liberal academics to keep the curtain closed and claim, “all is well in medical education.” Yet, as Queen Gertrude in “Hamlet” exclaimed, “The lady doth protest too much.” These declarations are too excessive and insistent to be believed.

It is complete folly, and dangerous, to believe that the selection and education of our future doctors should be based upon social justice parameters and identity politics.

If anyone speaks up against this, he or she is labeled a “bigot,” “racist,” “misogynist,” or whatever leftist attack word can be spat at them. The bottom line is that medicine should be about the patient, not the social identity of the physician.

When doctors make medicine about themselves, or their political affinity, they are degrading the very profession they took an oath to defend, and it will ultimately lead to patient harm.

We have witnessed the waiving of Medical College Admission Test scores for students to enter medical school. On medical school applications, prospective medical students check every identity politics box in hopes of a competitive advantage.

DEI apologists love to argue patients prefer to go to doctors who look like them. Perhaps, in some instances this is true. However, the logical conclusion of this position is segregation in the classroom and the doctor’s office.

In the classroom, precious time is being diverted from coursework to accommodate the addition of ideological classes. For example, UCLA Medical School, a once highly respected institution, has required students to take a “Structural Racism and Health Equity” course. It comes as no surprise that nearly a quarter of students in the school’s class of 2025 cannot pass basic medical exams. Social media is full of videos these days of medical students boasting that they failed their exams but that, “‘they will be a doctor anyway.” Where is the patient in all of this?

Disparities undoubtedly exist in medicine, and I’m deeply committed to addressing them. The current strategies prescribed to fix these imbalances are unmoored from reality and dangerous. I have spent the last 35 years serving a rural and heavy minority practice area to personally make a difference, not an urban Northeast, liberal echo chamber.

In all my years as a physician, I have never been more worried about the future of medicine. I cannot stand by and allow it to be corrupted by a political peer pressure campaign. The sinister movement to inject racial and political division into medical schools not only contradicts the principles of treating all patients equally and without partiality, but also materially impacts patient care and fosters distrust in our health care system.

We already have a severe physician workforce shortage; inserting politics into the field will degrade it further. Sadly, it will take a decade to see the clinical results of these horribly misguided policies and by that time it will be too late.

The push to implant DEI into every facet of our lives, including medicine, suggests that identity politics matter more than merit and work ethic. It is a Trojan horse for redistribution, segregation and racial division masquerading as a noble pursuit to stamp out oppression and offer everyone a fair shot at life.

Meaningful civil progress does not require deception to build a coalition of support. Although many who endorse the DEI movement may be well-intentioned, in medicine, the end results will be disastrous for the patient. The patient is what doctors are supposed to care about most.

Greg Murphy represents the 3rd District of North Carolina.

https://thehill.com/opinion/4755181-biden-health-diversity-equity/

Wisconsin high court rules absentee drop boxes can be used in November

The Wisconsin Supreme Court ruled on Friday that absentee drop boxes can be used ahead of the November election, reversing a previous 2022 ruling and delivering a win for Democrats.

In a 4-3 decision, the liberal-majority court ruled that dropping off an absentee ballot did constitute as returning it to a “municipal clerk,” reversing itself from its previous decision made by the then-conservative majority court arguing that it could be dropped off only at election offices.

“By mandating that an absentee ballot be returned not to the ‘municipal clerk’s office,’ but ‘to the municipal clerk,’ the legislature disclaimed the idea that the ballot must be delivered to a specific location and instead embraced delivery of an absentee ballot to a person — the ‘municipal clerk,’” Justice Ann Walsh Bradley, writing for the majority, said.

“Given this, the question then becomes whether delivery to a drop box constitutes delivery ‘to the municipal clerk,'” Bradley continued.

“We conclude that it does. A drop box is set up, maintained, secured, and emptied by the municipal clerk. This is the case even if the drop box is in a location other than the municipal clerk’s office,” the majority opinion said. “As analyzed, the statute does not specify a location to which a ballot must be returned and requires only that the ballot be delivered to a location the municipal clerk, within his or her discretion, designates.”

The decision by the liberal-controlled state Supreme Court is a blow to Republicans in the state. Absentee drop boxes became more popularly used during the COVID-19 pandemic, though Trump and some members of his party have baselessly claimed that it’s susceptible to fraud.

The decision in Wisconsin is particularly notable given that the state narrowly went for Biden in 2020 by less than a percentage point.

Wisconsin Democrats cheered the ruling in a statement.

“Today’s ruling affirms a basic principle: a democracy, we should make it easier for eligible voters to cast a ballot—not impose barriers based on conspiracy theories,” said Ben Wikler, state party chair. “By restoring access to safe and secure ballot drop boxes, the Court has ensured voters in communities across Wisconsin—cities big and small, in red areas and blue areas—are able to exercise their right to vote in a way that works for them.”

The ruling comes more than a year since the state’s high court flipped from a conservative majority to a liberal one when Justice Janet Protasiewicz won a special election for a vacant seat on the bench.

https://thehill.com/homenews/campaign/4756499-wisconsin-donald-trump-joe-biden-absentee-ballots/

'Ozempic better than insulin in lowering the risk of certain cancers'

Type 2 diabetes patients can significantly lower their risk for 10 obesity-related cancers if they take Ozempic instead of insulin to manage the disease, new research finds.

The study included 1.65 million people with Type 2 diabetes who were prescribed insulin, metformin or an Ozempic-like drug between March 2005 and November 2018.

Type 2 diabetes — which affects more than 34 million Americans — occurs when the body doesn’t produce enough insulin or doesn’t use insulin well, resulting in high blood sugar.

Metformin, injectable insulin and drugs like Ozempic that mimic the appetite-suppressing hormone GLP-1 can help people with Type 2 diabetes control their blood sugar levels. Ozempic has been shown to cause greater weight loss than metformin, while weight gain is a common side effect of insulin therapy.

In this latest study, researchers from Case Western Reserve University in Cleveland followed participants for 15 years. They found that GLP-1 drug users, compared to insulin patients, reduced their risk for esophageal, colorectal, kidney, pancreatic, gallbladder, ovarian, endometrial and liver cancers as well as meningioma (a tumor that forms in the head) and multiple myeloma (a rare blood cancer).

GLP-1 drugs did not lower the odds of postmenopausal breast cancer or thyroid cancer compared to insulin use — and the reduced risk for stomach cancer was not statistically significant, according to the findings published Friday in JAMA Network Open.

Ozempic’s safety information warns of the possibility of thyroid tumors and worsening kidney problems for those already experiencing issues.

Compared with metformin, GLP-1 drugs were not associated with a decreased cancer risk but the study found they did pose an increased risk of kidney cancer.

Ozempic and similar medications have become very popular in recent years for helping people drop lots of weight and keep their blood sugar in check. They have also been linked to a lower risk of heart attacks and alcoholism.

The Case Western research is not the first to suggest that Ozempic can protect against cancer.

A study published in December found that GLP-1 drugs decrease the risk of colorectal cancer in people with Type 2 diabetes compared to insulin or metformin.

The authors of the new study call for further exploration of Ozempic’s ability to prevent certain cancers.

Their research comes as the drug was recently linked to a higher risk for a rare blindness condition. Ozempic users have also reported changes in their tastes, faces and desires.

https://nypost.com/2024/07/05/lifestyle/ozempic-can-lower-risk-of-10-obesity-related-cancers-study/

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Friday, July 5, 2024