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Tuesday, April 2, 2024

US takes next step in Medicare drug price negotiations with pharma companies

  The Biden administration said on Tuesday it has responded to offers from the manufacturers of 10 high-cost drugs selected for the U.S. Medicare program's first-ever pricing negotiations, but provided no details.

Part of 2022's Inflation Reduction Act allows Medicare to negotiate prices for prescription drugs that had been particularly expensive for the federal health program that covers millions of Americans aged 65 and older as well as the disabled.

The agency overseeing Medicare, the Centers for Medicare and Medicaid Services (CMS), picked the first 10 drugs for negotiation in August and sent its initial price offers in February. The companies involved had until March 1 to respond and all did so.

Each company can meet with CMS up to three times for further negotiations before a final price is announced on Aug. 1. The negotiated prices will come into effect in 2026.

Drugs made by Bristol Myers Squibb, Pfizer, Merck & Co, Johnson & Johnson, AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, and Novo Nordisk were selected for negotiation.

A federal judge in Delaware on March 1 rejected AstraZeneca's lawsuit looking to block price negotiations, marking the third time the Biden administration's program has survived a court challenge.

https://finance.yahoo.com/news/us-takes-next-step-medicare-164711903.html

Two Weeks To Flatten Became Eight Months To Change The Election

 Via The Brownstone Institute,

In 1845, Congress established Election Day as the Tuesday after the first Monday of November. The Act sought “to establish a uniform time” for Americans to cast their ballots for president. Historically, voters needed to provide a valid reason – such as illness or military service – to qualify for absentee ballots.

But Covid served as a pretext to overturn that tradition. Just 25% of votes in 2020 occurred at the polls on Election Day. Mail-in voting more than doubled. Key swing states eliminated the need to provide a valid reason to cast absentee ballots. The virus and racial justice became justifications to disregard verification methods like signature requirements.

Rejection rates for absentee ballots plummeted by more than 80% in some states as the Covid regime welcomed an unprecedented increase in mail-in voting. Politicians and media outlets ignored rampant voter fraud in the months leading up to the election. They treated concerns surrounding absentee voting as obscure conspiracy theories despite a bipartisan commission describing it as “the largest source of potential voter fraud” just a decade earlier. 

It is now clear that the overhaul of our election system was a deliberate initiative from the outset of the pandemic response. In March 2020, when the Government’s official policy was still “two weeks to flatten the curve,” the administrative state began instituting the infrastructure to hijack the November presidential election, more than 30 weeks beyond when the Covid response was supposed to end. 

March 2020: The CDC and the CARES Act Meddle in the Election

On March 12, 2020, the CDC issued a recommendation for states and localities to “encourage voters to use voting methods that minimize direct contact with other people,” including “mail-in methods of voting.”

Two weeks later, President Trump signed the $2 trillion CARES Act, which offered states $400 million to re-engineer their election processes for that November. 

At the time, proponents of the CARES Act argued it was necessary to reopen the country. For example, the New York Times argued it was “critical to fund and implement the safety measures necessary to let Americans get back to work, school and play without a recurrence of the virus.”

But political actors immediately plotted ways to use the funds to entrench their power long past the proposed two-week lockdowns. Nearly every swing state announced plans to promote mail-in voting and reduce electoral safeguards in a Congressional report

“Michigan will use the funds to bolster vote by mail,” the report announced. Governor Gretchen Whitmer received $11.3 million from the CARES Act to change election procedures in her state. In November, 57% of Michigan voters (over 3 million people) cast their ballot by mail. For the first time, the state did not require a reason for absentee voting, and mail-in ballots more than doubled. President Trump would go on to lose Michigan by just 150,000 votes.

When Trump signed the CARES Act, just 0.05% of Michigan residents had tested positive for Covid. The state’s political leaders later boasted that their agenda had not been focused on public health. “Even when there’s not a pandemic, once people begin using the absentee ballot process, they’re much more likely to continue to do so in the future,” said Michigan Secretary of State Jocelyn Benson after Election Day.

Pennsylvania received $14.2 million from the CARES Act to address its election process. At the time, the infection rate in the Keystone State was 1 in 6,000 (0.017%). Democratic Governor Tom Wolf’s administration told the federal government it would use its plans to increase absentee voting. In November, 2.5 million Pennsylvanians voted by mail. President Biden won 75% of those votes – a difference of 1.4 million. President Trump lost the state by under 100,000 votes.

The CARES Act provided Wisconsin with over $7 million for election matters. Democratic Governor Tom Evers said the state would use funds to provide “absentee ballot envelopes,” to develop “the statewide voter registration system and online absentee ballot request portal,” and “to account for additional costs” related to mail-in voting.

Governor Evers explained, “Having as many absentee ballots as possible is absolutely a top priority [and] always has been given the emergency we’re in.” Eight months later, 1.9 million of the state’s 3.3 million voters cast their ballot by mail. The rejection rate for absentee ballots plummeted from 1.4% in 2016 to 0.2%. President Biden won Wisconsin by just 20,000 votes. 

Democratic activists were unsatisfied with the $400 million added to the national debt to reshape the elections. Mark Zuckerberg’s foundation offered an additional $300 million. In Time, Molly Ball celebrated the “shadow campaign that saved the 2020 election.” She quoted Amber McReynolds, the president of “nonpartisan National Vote at Home Institute,” who called the government’s reluctance to provide additional funding “a failure at the federal level.” Despite her professed “non-partisanship,” President Biden rewarded her service by appointing her to the Board of the US Postal Service. 

In Time, Ball hailed the mail-in activists’ efforts, which included targeting “Black voters” who may have otherwise “preferred to exercise their franchise in person.” They focused on social media outreach to try to convince people that a “prolonged [vote] count wasn’t a sign of problems.” Their informational warfare may have changed Americans’ perception on mail-in voting, but it could not eradicate the predictable controversies that it created. 

April and May 2020: Voter Fraud Skyrockets

In May 2020, New Jersey held municipal elections and required all voting take place via mail. The State’s third largest city, Paterson, held its election for city council. The results should have been a national scandal that ended the push for mail-in voting.

Shortly after the election, the Postal Service discovered “hundreds of mail-in ballots” in one town mailbox. A Snapchat video showed a man named Abu Razyen illegally handling a stack of ballots he said was for candidate Shanin Khalique. Khalique initially defeated his opponent by just eight votes. A recount found their vote was tied.

Paterson resident Ramona Javier never received her mail-in ballot for the election. Neither did eight of her family members and neighbors, yet they were all listed as having voted. “We did not receive vote-by-mail ballots and thus we did not vote,” she told the press. “This is corruption. This is fraud.”

Election officials rejected 19% of the ballots from Paterson, a city with over 150,000 residents. While Paterson’s election was particularly troublesome, mail-in ballots were problematic across the state. Thirty other New Jersey municipalities held vote-by-mail elections that day, and the average disqualification rate was 9.6%.

New Jersey brought voting fraud charges against City Councilman Michael Jackson, Councilman-Elect Alex Mendez, and two other men for their “criminal conduct involving mail-in ballots during the election.” All four were charged with illegally collecting, procuring, and submitting mail-in ballots.

A state judge later ordered a new vote, finding that the May election “was not the fair, free and full expression of the intent of the voters. It was rife with mail in vote procedural violations constituting nonfeasance and malfeasance.”

Politicians refused to concede that the incident revealed the vulnerability of absentee balloting. Instead, Governor Phil Murphy told the press that the scandal was a good sign. “I view that as a positive data point,” he argued. “Some guys tried to screw around with the system. They got caught by law enforcement. They’ve been indicted. They’ll pay a price.”

Murphy and other allies of Joe Biden ignored the threat, presuming the forces would not hurt their hopes that November. 

In Wisconsin, the April 2020 primary election offered further evidence of the challenges and corruption surrounding mail-in voting. Following the primary, a postal center outside Milwaukee discovered three tubs of absentee ballots that never reached their intended recipients. Fox Point, a village outside Milwaukee, has a population of under 7,000 people. 

Beginning in March, Fox Point received between 20 and 50 undelivered absentee ballots per day. In the weeks leading up to the election, the village manager said that increased to between 100 and 150 ballots per day. On election day, the town received a plastic mail bin with 175 unmailed ballots. “We’re not sure why this happened,” said the village manager. “Nobody seems to be able to tell me why.”

Democrats admitted the system threatened election integrity. “This has all the makings of a Florida 2000 if we have a close race,” said Gordon Hintz, the Democratic minority leader in the Wisconsin State Assembly. New York Governor Andrew Cuomo went further. “It’s a harder system to administer, and obviously it’s a harder system to police writ large,” he said. Cuomo continued, “People showing up, people actually showing ID, is still the easiest system to assure total integrity.”

The Wisconsin primary also featured special elections for the Wisconsin Supreme Court. A liberal judge upset the incumbent conservative justice, and partisans embraced their overhaul of the electoral system. The New York Times reported: “Wisconsin Democrats are working to export their template for success – intense digital outreach and a well-coordinated vote-by-mail operation – to other states in the hope that it will improve the party’s chances in local and statewide elections and in the quest to unseat President Trump in November.”

Despite the corruption, the lost ballots, and the admissions of threats to electoral integrity, the process had been a success in political terms; their candidate had won. The ends had justified the means. Citizens lost faith in their election process, and political leaders readily admitted that their concerns were justified; but the professional politicos and their mouthpiece, the New York Times, characterized the disaster as a “template for success.”

Controversies continued to emerge surrounding mail-in ballots.

In September 2020, a government contractor threw Trump mail-in ballots in the trash in Pennsylvania. ABC News reported that “ballots had been found in a dumpster next to the elections building.” A week later, three trays of mail with absentee ballots were found in a ditch in Wisconsin.

In Nevada, the Reno-Sparks Indian Colony offered gifts, including gift cards, jewelry, and clothing to Native Americans who showed up to vote. Activist Bethany Sam organized the event, where she donned a Biden-Harris mask and stood in front of the Biden-Harris campaign bus.

Voters in California received ballots with no place to vote for president, over 20% of ballots mailed to voters in Teaneck, New Jersey, had the wrong Congressional districts listed, and Franklin County, Ohio reported sending over 100,000 absentee ballots to the wrong address due to an “envelope stuffing error.”

In October, Texas police arrested Carrollton Mayoral Candidate Zul Mirza Mohamed on 109 counts of fraud for forging mail-in ballots. Authorities discovered fraudulent ballots at Mohamed’s residence with fictitious licenses. That same month, a Pennsylvania district attorney charged Lehigh County Elections Judge Everett “Erika” Bickford with “prying into ballots” and altering the entries from a local election that June. That election was decided by just 55 votes.

Reports continued to emerge after the election. The New York Post uncovered election records that showed dead people had cast absentee ballots that November.

California law enforcement arrested two men with a 41-count criminal complaint for allegedly submitting over 8,000 fraudulent voter registration applications on behalf of homeless people. Their goal was to get Carlos Montenegro, one of the defendants, elected Mayor of Hawthorne, a city in Los Angeles County. The state also alleged that Montenegro committed perjury by falsifying names and signatures in his paperwork for his mayoral campaign.

In 2022, a Georgia investigation found more than 1,000 absentee ballots that never left the Cobb County government facility. Two months earlier, mail-in ballots from the 2020 election were discovered in a Baltimore USPS facility. In 2023, Michigan police found hundreds of mail-in ballots from the 2020 election in a township clerk’s storage unit.

All of this was entirely predictable, but perhaps that was the point. From the outset, the Covid regime sought to abolish the safeguards of our election system despite well-known concerns regarding election integrity. 

The United States of Amnesia: Voter Fraud Was Nothing New

The Covid regime’s messaging was clear: only conspiratorial lunatics would question the integrity of an election system that more than doubles its mail-in voting. FBI Director Christopher Wray testified, “We have not seen, historically, any kind of coordinated national voter fraud effort in a major election, whether it’s by mail or otherwise.”

But this wasn’t true. It contradicted long-standing conclusions regarding electoral integrity. Just as the public health apparatus abandoned thousands of years of epidemiological practice to implement lockdowns, the media and elected officials abandoned principles that until that moment had been common sense.

Following the controversy of the 2000 Presidential election, the United States formed a bipartisan Commission on Federal Election Reform. President Jimmy Carter, a Democrat, and former Secretary of State James Baker, a Republican, chaired the group.

After five years of research, the group published its final report – “Building Confidence in U.S. Elections.” It offered a series of recommendations to reduce voter fraud, including enacting voter-ID laws and limiting absentee voting. The commission was unequivocal: “Absentee ballots remain the largest source of potential voter fraud.”

The report continued: “Citizens who vote at home, at nursing homes, at the workplace, or in church are more susceptible to pressure, overt and subtle, or to intimidation. Vote buying schemes are far more difficult to detect when citizens vote by mail.”

The findings were reinforced by subsequent election scandals. 

A 2012 New York Times headline read: “Error and Fraud at Issue as Absentee Voting Rises.” The article made the front page of the paper and echoed the concerns of the Carter-Baker Commission. “Fraud Easier via Mail,” the paper explained.

“You could steal some absentee ballots or stuff a ballot box or bribe an election administrator or fiddle with an electronic voting machine,” said Yale Law professor Heather Gerken. That explains, she said, “why all the evidence of stolen elections involves absentee ballots and the like.”

The Times continued the potential corruption of mail-in ballots. “On the most basic level, absentee voting replaces the oversight that exists at polling places with something akin to an honor system,” the author wrote. The Times then cited US Circuit Court Judge Richard A. Posner: “Absentee voting is to voting in person as a take-home exam is to a proctored one.”

The report went on: “Voters in nursing homes can be subjected to subtle pressure, outright intimidation or fraud. The secrecy of their voting is easily compromised. And their ballots can be intercepted both coming and going.”

Historic controversies supported this consensus. The 1997 Miami mayoral election resulted in 36 arrests for absentee-ballot fraud. A judge voided the results and ordered the city to hold a new election due to “a pattern of fraudulent, intentional, and criminal conduct.” The results were reversed in the subsequent election.

Following Dallas’s 2017 City Council race, authorities sequestered 700 mail-in ballots signed “Jose Rodriguez.” Elderly voters alleged that party activists had forged their signatures on their mail-in ballots. Miguel Hernandez later pled guilty to the crime of forging their signatures after collecting unfilled ballots, and using them to support his candidate of choice.

The following year, it appeared that Republic Mark Harris defeated Democrat Dan McCready in a North Carolina congressional race. Election officials noticed irregularities in the mail-in votes and refused to certify the election, citing evidence and “claims of…concerted fraudulent activities.” The state ordered a special election the following year.

In 2018, the Democratic National Commission challenged an Arizona law that set safeguards around absentee voting, including limiting who could handle mail-in ballots. US District Judge Douglas L. Rayes, an Obama appointee, upheld the law. “Indeed, mail-in ballots by their very nature are less secure than ballots cast in person at polling locations,” he wrote. He found that “the prevention of voter fraud and preservation of public confidence in election integrity” were important state interests and cited the Carter-Baker Commission’s finding that “Absentee ballots remain the largest source of potential voter fraud.”

The rest of the world recognized the obvious threat that mail-in voting poses to election integrity. In 1975, France banned postal ballots after rampant voter fraud. Ballots were cast with the names of dead Frenchmen, and political activists in Corsica stole ballots and bribed voters. 

In 1991, Mexico mandated voter photo IDs and banned absentee ballots after the Institutional Revolutionary Party repeatedly committed fraud to maintain power. In Austria, Belgium, Canada, Chile, Denmark, Estonia, Ireland, Lithuania, Luxembourg, Poland, Portugal, Slovenia, Spain, Turkey, and the United Kingdom, photo ID is required to get an absentee ballot.

In August 2020, economist John Lott analyzed how Covid was being used as a pretext to overhaul electoral standards in the United States. He wrote

Thirty-seven states have so far changed their mail-in voting procedures this year in response to the Coronavirus. Despite frequent claims that President Trump’s warning about vote fraud/voting buying with mail-in ballots is “baselessly” or “without evidence” about mail-in vote fraud, there are numerous examples of vote fraud and vote buying with mail-in ballots in the United States and across the world. Indeed, concerns over vote fraud and vote buying with mail-in ballots causes the vast majority of countries to ban mail-in voting unless the citizen is living abroad.

There are fraud problems with mail-in absentee ballots but the problems with universal mail-in ballots are much more significant. Still most countries ban even absentee ballots for people living in their countries.

Most developed countries ban absentee ballots unless the citizen is living abroad or require Photo-IDs to obtain those ballots. Even higher percentages of European Union or other European countries ban absentee for in country voters.

Political actors treated opposition to absentee balloting with scorn while ignoring its history of corruption. Mail-in voting may have been the decisive factor in the 2020 election, but Trump and his allies searched for other explanations to avoid his complicity in signing the CARES Act. 

The Trump campaign promised to produce “irrefutable” evidence that proved Trump won the election “in a landslide.” “I’m going to release the Kraken,” one Trump election lawyer told Lou Dobbs in November 2020. President Trump and Rudy Giuliani tweeted blame at Dominion voting machines. Sean Hannity said privately that Giuliani was “acting like an insane person.” 

Two days later, he told viewers about a “software error” from Dominion that “wrongfully awarded Joe Biden thousands of ballots that were cast for President Trump, until the problem was amazingly fixed.” In August 2023, Trump announced that he would release an “irrefutable report” demonstrating voter fraud in Georgia. He canceled the announcement two days later.

In the process, they ignored a far more obvious explanation.

Presidential elections in the 21st century have been decided by an average of 44 electoral votes. Pennsylvania, Georgia, Michigan, and Wisconsin offer a combined 62 votes in the Electoral College.

Under the pretext of Covid, states abolished their electoral safeguards.

They turned Election Day into a month of voting.

After prominent Democrats refused to certify the 2000, 2004, and 2016 elections, the victors chastised any concerns for electoral integrity as attacks on democracy.

This is all theater. From the outset of the pandemic response, the liberalization of voting rules was integral, all justified based on nonscientific grounds while invoking the cover of science. It wasn’t stopping disease spread that drove the dramatic upheaval in the American system of voting that has caused such widespread distrust. It was the drive for a result different from one that swept the country four years earlier. 

https://www.zerohedge.com/political/two-weeks-flatten-became-eight-months-change-election

HHS Clarifies Informed Consent Requirements for Exams Under Anesthesia

 HHS on Monday revised and clarified requirements for informed consent

opens in a new tab or window for certain procedures done in the hospital, especially examinations done while the patient is under anesthesia.

"It is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent from patients before performing sensitive examinations in all circumstances," the agency said in a press release. "Informed consent includes the right to refuse consent for sensitive examinations conducted for teaching purposes and the right to refuse to consent to any previously unagreed examinations to treatment while under anesthesia."

The agency noted that the guidance also comes amidst "media reports, as well as medical and scientific literature, highlighting instances where, as part of medical students' courses of study and training, patients have been subjected to sensitive and intimate examinations -- including pelvic, breast, prostate, or rectal examinations -- while under anesthesia without proper informed consent being obtained prior to the examination."

recent storyopens in a new tab or window posted by the Cleveland, Ohio, ABC News affiliate noted that 25 states have banned the performance of pelvic exams by medical students without specific patient consent. A study by the Hastings Center, a bioethics research institute, estimated as many as 3.6 million U.S. women and men may have received an intimate exam without their consent within the past 5 years, the story said; it quoted Alexandra Fountaine, a fourth-year Ohio University medical student, who said having medical students perform pelvic exams without patient consent "is very common practice" and "happens a lot."

On Monday, HHS Secretary Xavier Becerra, CMS Administrator Chiquita Brooks-LaSure, and HHS Office for Civil Rights (OCR) Director Melanie Fontes Rainer wrote a letteropens in a new tab or window to teaching hospitals and medical schools reminding them that the OCR investigates complaints alleging that patients' protected health information was used or disclosed to medical trainees in violation of the Health Insurance Portability and Accountability Act (HIPAA).

HIPAA "safeguards protected health information (PHI) from impermissible use and disclosure, and further gives individuals the right to restrict who has access to their PHI, including in scenarios where they may be unconscious during a medical procedure," they wrote, adding that the OCR recently issued a frequently asked questions documentopens in a new tab or window explaining this right.

OCR also enforces federal civil rights laws, including a provision in the Affordable Care Act which prohibits discrimination on the basis of sex, race, national origin, age, and disability, the letter said. "OCR has previously worked with, and will continue to work with, covered entities to ensure that their policies and practices related to sensitive examinations do not discriminate against patients on any of these bases."

"While we recognize that medical training on patients is an important aspect of medical education, this guidance aligns with the standard of care of many major medical organizations, as well as state laws that have enacted explicit protections as well. Informed consent is the law and essential to maintaining trust in the patient-provider relationship and respecting patients' autonomy," they concluded. "We welcome the opportunity to work with providers to promote compliance with existing federal laws and plan to hold a webinar regarding this requirement soon."

https://www.medpagetoday.com/hospitalbasedmedicine/generalhospitalpractice/109449

Are Federal Agencies Coming for Ketamine Clinics?

 Could existing pills for certain manifestations of mental health disorders soon become old-fashioned approaches

opens in a new tab or window to treat such things as PTSD, depression, anxiety, and even chronic pain?

The potential replacement: ketamine, and the clinics popping up everywhere to serve it.

Ketamine clinics have gained popularityopens in a new tab or window in recent years by offering ketamine infusion treatments to patients suffering from debilitating mental health disorders. Some patients may seek out these services to avoid the side effects of other more commonly prescribed drugs, or in cases when their mental health condition is seen as "treatment-resistantopens in a new tab or window" -- ketamine's fast-acting properties make it an attractive option for patients who have not responded wellopens in a new tab or window to traditional treatments.

The public response has been nothing less than explosive: Ketamine therapies have now become a $3.1 billion industryopens in a new tab or window, with nearly 50% of the market maintained online as telehealth services.

However, the lack of rigorous scientific research -- compared to other treatment modalities -- supporting its long-term effectiveness and safety has raised eyebrows among medical professionals. Only one ketamine product is FDA-approved for treating mood disorders -- the nasal spray esketamine (Spravato). It's specifically indicated for use in conjunction with an oral antidepressant for adults with treatment-resistant depression, and it's only available through a Risk Evaluation and Mitigation Strategy (REMS) program. Yet, that hasn't stopped many clinics from jumping aheadopens in a new tab or window of the evidence. Now, other eyebrows are being raised: notably, among regulatory authorities. Agencies -- the FDA and the Department of Justice (DOJ) -- are starting to ask questions.

First in February 2022opens in a new tab or window and then again in October 2023opens in a new tab or window, FDA issued cautionary statements regarding the potential risks associated with the utilization of compounded ketamine, warnings that should be seen as the first red flag waved at providers who offer the treatment. Compounded medications are sourced from independent pharmacies and used off-label, or in ways that are not directly approved by the FDA. Ketamine providers that operate through telemedicine are a source for compounded ketamine supplied to patients. Notably, telehealth providers are also increasingly becoming targetsopens in a new tab or window in government healthcare investigations.

The FDA's warnings are underscored by reports of negative incidentsopens in a new tab or window linked to off-label usage of ketamine, which has led to heightened risks of severe psychiatric reactions. Ketamine use can also lead to other health complicationsopens in a new tab or window: hypertension, respiratory dysfunction, and serious urinary tract issues including incontinence.

It bears repeating that ketamine clinics should view the FDA's warning as a bellwether for potential regulatory action. The DOJ has already begun taking action against individual physicians.

Just a few months ago, two St. Louis-based physicians running a ketamine clinic were jointly indictedopens in a new tab or window on an array of felony charges ranging from allegedly conspiring to commit healthcare fraud to dispersing controlled substances illegally.

Last year, a physician who built a nationwide ketamine telemedicine practice was shut downopens in a new tab or window by the Drug Enforcement Agency (DEA).

The timing of this is not by any means random. The increasing vigilanceopens in a new tab or window over ketamine clinics can largely be attributed to its escalating popularity. Within the healthcare sector, such trends tend to evoke scrutiny as the popularity of a particular patient model or therapeutic modality burgeons. Consider Medicare Advantage plans, which gained significant traction in recent years -- today, they face an unprecedented level of inquiryopens in a new tab or window from federal regulators. Ketamine clinics and their operators should anticipate a similar trajectory.

Some argue that ketamine clinics provide a much-needed alternativeopens in a new tab or window for individuals who have exhausted other treatment options. For patients who have suffered from treatment-resistant depression or chronic pain, ketamine infusions have shown promising resultsopens in a new tab or window, providing them with relief and a renewed sense of hope.

Yet, ketamine-clinic critics express concerns regarding the absence of standardized protocols and guidelinesopens in a new tab or window. Without a clear framework in place, there exists a high risk that some clinics may prioritize profit over patient safety, potentially exposing individuals to unnecessary harm -- especially when ketamine therapies are offered online without a physician's proper oversight and care.

Additionally, the misuse and abuse of ketamine, both in and outside of these clinics, further compounds these concerns.

Ketamine is a powerful dissociative anestheticopens in a new tab or window that can induce hallucinations and alter perception. When used outside of its intended clinical scope, ketamine can have serious consequences for individuals' physical and mental health. It carries the risk of addiction, psychosis, and cognitive impairments. The lax regulations within many ketamine clinics could inadvertently contribute to the accessibility and diversion of this potent substance, increasing the chances of misuse and addiction.

In order to address these concerns, it is crucial that ketamine clinics implement a robust compliance systemopens in a new tab or window. Establishing standardized protocols, training requirements for medical professionals, and monitoring systems can help ensure that these clinics deliver safe and effective care to patients. Additionally, public awareness campaigns and educational initiatives can help inform people about the risks associated with ketamine misuse and abuse.

Health associations and regulatory bodies are looking closely at the practices and operationsopens in a new tab or window of ketamine clinics across the country. Their aim is to ensure that these clinics are adhering to proper medical standardsopens in a new tab or window, and this increased scrutiny could potentially lead to stricter regulations, including mandatory training and certification for ketamine providers, as well as more frequent inspections and oversight.

The cost of building a framework for compliance upfront is far more economic than doling out legal fees to attorneys to adjudicate regulatory compliance in court.

As the medical community continues to explore the benefits and risks of ketamine treatment, regulators and healthcare professionals should find ways to work together to establish clear guidelines and standards. Only then can we ensure that ketamine therapy continues to be a viable option for those in need.

Jay K. Joshi, MD, is a practicing physician and entrepreneur in Northwest Indiana. He is also an advocate for physicians to ensure they receive proper due diligence in civil and criminal litigation. He is the author of the book Burden of Painopens in a new tab or window, and he regularly blogs on his site, Daily Remedyopens in a new tab or window. Ron Chapman II, JD, LLM, is a federal criminal defense attorney and president of Chapman Consulting Groupopens in a new tab or window.

https://www.medpagetoday.com/opinion/second-opinions/109451

Defense Official Had Havana Syndrome Symptoms at NATO Summit, Pentagon Confirms

 A senior Department of Defense (DOD) official who attended last year's NATO summit in Vilnius, Lithuania, had symptoms similar to those reported by U.S. officials who have experienced "Havana syndrome

opens in a new tab or window," the Pentagon confirmed Monday.

Havana syndrome is still under investigation but includes a string of health problems dating back to 2016, when officials working at the U.S. Embassy in Havana reported sudden unexplained head pressure, head or ear pain, or dizziness.

The injuries to U.S. government personnel or their families were part of a "60 Minutes" report Sunday that suggested Russia is behind the incidents, one of which took place during the 2023 NATO summit in Vilnius.

"I can confirm that a senior DOD official experienced symptoms similar to those reported in anomalous health incidents," deputy press secretary Sabrina Singh told reporters Monday. Singh referred questions on whether Russia had a role to the intelligence community, which is still investigating.

The official, who was not identified, was not part of Defense Secretary Lloyd Austin's official traveling delegation to Vilnius, Singh said, but was there "separately, attending meetings that were part of the NATO summit."

Singh did not say whether the affected defense official had to seek further medical care, retire, or cease performing duties, citing medical privacy.

In February, the Office of the Director of National Intelligence in its 2024 threat assessment found that it was "unlikely" that a foreign adversary was responsible for causing the mysterious ailmentsopens in a new tab or window but noted that U.S. intelligence agencies had varying levels of confidence in that assessment.

State Department spokesman Matthew Miller told reporters on Monday the department has confidence in that assessment.

"It has been the broad conclusion of the intelligence community since March 2023 that is unlikely a foreign adversary is responsible for these anomalous health incidents," Miller said. "It's something that the intelligence community has investigated extensively and continues to look at. We will look at new information as it comes in and make assessments inside the State Department and with our intelligence community."

The foremost Cuba-based researcher of the incidents, Mitchell Valdés-Sosa, MD, PhD, told the Associated Press that the "60 Minutes" report had failed to provide any scientific basis to substantiate the existence of the Havana syndrome. Valdés-Sosa, director of Cuba's Center for Neuroscience, is the de facto spokesperson on the issue for the Cuban health ministry, which arranged the interview.

"I think that this journalistic investigation does not provide serious elements, especially that there is a new illness caused by a mysterious energy," he said. "The symptoms are very varied: balance problems, sleep problems, dizziness, difficulties concentrating, and many diseases can cause them."

In the past, Valdés-Sosa hasn't disputedopens in a new tab or window that diplomats become ill, but suggested that many of the cases consisted of ordinary illnesses that were erroneously blamed on the supposed phenomenon due to the high degree of public attention.

The Pentagon's healthcare system has established a registry for employees or dependents to report such incidents. In March, however, a 5-year study by the National Institutes of Health found no brain injuries or degenerationopens in a new tab or window among U.S. diplomats and other government employees who had Havana syndrome symptoms.

https://www.medpagetoday.com/washington-watch/washington-watch/109460

Too Old for Surveillance Colonoscopy?

 Colorectal cancer was rarely detected via surveillance colonoscopies in older adults regardless of prior adenoma finding, a large observational study found.

Among 9,601 patients ages 70 to 85 with a history of adenoma, 0.3% of surveillance colonoscopies found colorectal cancer, while 11.7% found advanced adenoma, and 12% found advanced neoplasia. Results did not differ significantly by age, said researchers led by Jeffrey Lee, MD, MPH, of Kaiser Permanente Northern California in Oakland.

Patients with a history of advanced adenoma versus non-advanced were more likely to have colorectal cancer detected by surveillance, though still rarely (0.5% vs 0.2%, P=0.02), and were more likely to have advanced neoplasia (16.5% vs 10.6%, P<0.001), Lee's group reported in JAMA Network Openopens in a new tab or window.

The findings can help inform whether to continue surveillance colonoscopy in older adults, Lee and co-authors said.

"Given the increasing aging population in the U.S. and that nearly 5.6 million adults older than 75 years will undergo surveillance annually by 2024, estimating the yield of surveillance colonoscopy is important for understanding the balance between potential benefits and known risks of colonoscopy with advancing age," they wrote.

In the U.S., approximately 40% of screening colonoscopies find adenomas, and guidelines recommend patients have surveillance colonoscopy after undergoing polypectomy. However, guidelines don't specify an age at which surveillance is unlikely to be of substantial benefit and could be stopped, Lee and colleagues noted.

Risks associated with colonoscopy increase particularly among patients 75 years or older, and include heart attack, stroke, sedation-related adverse events such as aspiration pneumonia, bleeding, infection, and perforation, Lee's group observed.

"These findings provide some of the first large-scale, community-based information on the yield of surveillance colonoscopy among older adults," they wrote.

They highlighted two key findings that could inform shared decision making about surveillance colonoscopy. First, colorectal cancer was rarely detected among older adults with prior advanced or non-advanced adenomas. "Thus, for many older adults, particularly those with a prior nonadvanced adenoma, the low rate of [colorectal cancer] detection at surveillance may not justify the potential harms and burdens of colonoscopy that may increase with age," the study authors said.

They did note that for older adults with a predicted life expectancy of 10 or more years and without significant competing comorbidities, detecting early-stage colorectal cancer or advanced adenomas at surveillance could lead to earlier treatment and improved outcomes, especially for those with a prior advanced adenoma.

Second, advanced adenoma was more commonly detected than colorectal cancer, however advanced adenomas themselves are not harmful to patients; for the rare lesions that do progress to invasive cancer, the process takes several years. "Thus, among older adults with limited life expectancies due to comorbidities, few would likely benefit from the detection and removal of these polyps," they said.

"With current guidelines offering no specific age at which to stop surveillance colonoscopy, the study findings can inform clinicians and older patients regarding the potential benefits (or lack of benefits) of continuing with post polypectomy surveillance in the context of the life expectancy of the patient and weighed against the rare but known harms of colonoscopy, which increase with advancing age and comorbidities," the researchers concluded.

Agreeing with the researchers, John Carethers, MD, of the University of California San Diego and past president of the American Gastroenterological Associationopens in a new tab or window, commented this study does not specifically answer the question on the age to stop post-polypectomy surveillance, "but does inform the likelihood of a septa- or octogenarian who has previously had advanced neoplasia is more likely to develop it again, but rarely as cancer."

Carethers, who wasn't involved with the research, told MedPage Today this study "adds one more piece that was not previously known toward the patient-provider discussion on whether to perform a surveillance colonoscopy, with its increasing risk as one ages, with any benefits in preventing the extremely low risk for subsequent cancer."

The population-based, cross-sectional study included patients 70 to 85 with a history of adenoma. Participants underwent a surveillance colonoscopy from 2017-2019 at Kaiser Permanente Northern California, a large, community-based U.S. healthcare system. Individuals with prior colorectal cancer, hereditary colorectal cancer syndrome, inflammatory bowel disease, or prior colectomy were excluded.

Data were analyzed from 2022-2024. The main outcomes were detection of colorectal cancer, advanced adenoma, and advanced neoplasia overall by age and by prior adenoma finding (advanced vs non-advanced).

An important limitation of the study was its cross-sectional design, the study authors noted. The follow-up time was limited, and colorectal cancer may take many years to develop. In addition, the study population was from a large healthcare system and limited to patients with prior adenoma. The results might not be generalizable to unscreened patients who could be at higher risk, they said.

Disclosures

The study was supported by the National Cancer Institute.

Lee reported no potential conflicts of interest.

One co-author reported a relationship with Freenome. No other relationships with industry were reported.

Primary Source

JAMA Network Open

Source Reference: opens in a new tab or windowLee JK et al "Surveillance colonoscopy findings in older adults with a history of colorectal adenomas" JAMA Netw Open 2024; DOI: 10.1001/jamanetworkopen.2024.4611.


https://www.medpagetoday.com/gastroenterology/coloncancer/109461