Myocarditis Harm From mRNA COVID Vaccines, Report Determines

Independent reviewers confirmed a causal relationship between the first mRNA COVID-19 vaccines and myocarditis, and also determined that, more broadly, intramuscular shots can cause a series of shoulder injuries.

At the same time, the National Academies of Sciences, Engineering, and Medicine (NASEM) committee rejected a causal relationship between the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 (Comirnaty and Spikevax, respectively) mRNA COVID vaccines and female infertility, Guillain-Barré syndrome, Bell's palsy, thrombosis with thrombocytopenia syndrome (TTS), and myocardial infarction.

The evidence was also deemed enough to reject a causal link between the Pfizer vaccine and ischemic stroke. There was insufficient data to say the same for the Moderna one, however, according to a reportopens in a new tab or window commissioned by the Health Resources and Services Administration (HRSA), a subagency of the HHS.

"Despite a large body of evidence from extraordinary efforts by investigators around the world, our committee found that in many cases, if not most, evidence was insufficient to accept or reject causality for a particular potential harm from a specific COVID-19 vaccine," said committee vice chair Anne Bass, MD, of Weill Cornell Medicine, Hospital for Special Surgery, and New York-Presbyterian Hospital, New York City, in a press releaseopens in a new tab or window.

"In other cases, we did find sufficient evidence to favor rejection, favor acceptance, or establish causality. It is important to note, however, that identifying a harm does not mean that it occurs frequently," she cautioned. "Harms associated with vaccines are rare."

HRSA had requested this review from NASEM, an independent nonprofit, in order to address claims for compensation under its Countermeasures Injury Compensation Program. This federal program provides compensation related to injuries from pandemic, epidemic, or security countermeasures.

The link between the mRNA vaccines and myocarditis has been probed in many studies since initial reports were logged into the voluntary Vaccine Adverse Event Reporting System (VAERSopens in a new tab or window) in April 2021. Reports consistently described myocarditis associated with COVID vaccines as mostly mildopens in a new tab or window. Detailed recordsopens in a new tab or window showed that affected vaccine recipients tended to be men and adolescent boysopens in a new tab or window who were typically able to recover after a few days in the hospital.

The feared spike in sudden cardiac deaths among affected individuals with myocarditis has not been realized. For example, a recent study from Oregonopens in a new tab or window reported no excess sudden cardiac deaths among young people soon after COVID-19 mRNA vaccination.

"Given that the studies we reviewed were performed shortly after vaccines were available, the information in this report is a snapshot in time, and new vaccines will be developed and more research conducted," said committee chair George Isham, MD, of HealthPartners Institute in Minnesota.

"For example, the evidence does not address the real-world use of the COVID-19 vaccines in which many individuals received a 'mix and match'opens in a new tab or window sequence of them. Many people vaccinated for COVID-19 also received other vaccines, such as influenza, simultaneously," Isham added in a statement.

In 2022, Pfizer and Moderna had their first-generation mRNA COVID vaccines replaced by bivalent versions blending protection against the ancestral COVID strain and the Omicron BA.4/5 subvariants circulating at the time. They were not as widely adopted as the original vaccines, and initially suspected of a potential stroke risk until suspicion turned to high-dose or adjuvanted flu shots insteadopens in a new tab or window.

The bivalent vaccines remained available until the arrival of monovalent vaccines targeting the XBB.1.5 Omicron subvariantopens in a new tab or window for the 2023-2024 respiratory virus season.

For its present report, NASEM also reviewed the evidence for two other COVID-19 vaccines, the Johnson & Johnson (J&J) adenovirus vector vaccine (Ad26.COV2.S) and the Novavax protein-based vaccine (NVX-CoV2373).

The verdict: the J&J vaccine may cause TTSopens in a new tab or window and Guillain-Barré syndromeopens in a new tab or window (this vaccine was withdrawn from the market in 2023) while evidence for the Novavax shot was insufficient to accept or reject a causal relationship with any of the 19 side effects of interest.

Beyond those already noted, the side effects investigated included chronic inflammatory demyelinating polyneuropathy; transverse myelitis; chronic headache; postural orthostatic tachycardia syndrome; sensorineural hearing loss; tinnitus; immune thrombocytopenic purpura; capillary leak syndrome; hemorrhagic stroke; deep vein thrombosis, pulmonary embolism, or venous thromboembolism; pericarditis without myocarditis; and sudden death.

A more general investigation also established a general causal relationship between intramuscular administration of routinely administered vaccines and various shoulder injuries:

• Subacromial/subdeltoid bursitis caused by direct injection into the bursa
• Acute rotator cuff or acute biceps tendinopathy caused by direct injection into or adjacent to a tendon
• Bone injury caused by direct injection into or adjacent to the bone
• Axillary or radial nerve injury caused by direct injection into or adjacent to the nerve

The NASEM reviewers acknowledged that there was not enough evidence for conclusions to be made about potential harms to children, especially children under age 11.

Disclosures

The study was supported by a contract between the National Academy of Sciences and Health Resources and Services Administration (of HHS), which includes funds from the CDC.

Committee members did not report relevant conflicts of interest.

Primary Source

National Academies of Sciences, Engineering, and Medicine

Source Reference: opens in a new tab or windowBass AR, et al "Evidence review of the adverse effects of COVID-19 vaccination and intramuscular vaccine administration" National Academies Press; DOI: 10.17226/27746.

https://www.medpagetoday.com/infectiousdisease/covid19vaccine/109700

Counterfeit 'Botox' Spreading Across the U.S., CDC Warns

 The CDC is investigating harmful botulism-like reactions in 19 people who received counterfeit or mishandled botulinum toxin (Botox), according to a new reportopens in a new tab or window

.

The FDA also issued its own alertopens in a new tab or window today, with information for healthcare providers on how to identify the counterfeit products.

As of April 12, nine people have been hospitalized after receiving the botulinum toxin injections, primarily for cosmetic purposes.

The people who received the injections were all women, and ranged in age from 25 to 59 years. All affected people reported that they received the injections in non-healthcare settings, such as homes or spas, or from unlicensed or untrained individuals, the CDC said. The injections appear to be counterfeit products or products with unverified sources, the report said, and investigation into the sources of these products is ongoing.

According to the FDA, there is no indication that any of the reported events were linked to AbbVie's FDA-approved Botox. The genuine product should be considered safe and effective, the FDA alert said.

Cases have been reported across nine states, including Colorado, Florida, Illinois, Kentucky, Nebraska, New Jersey, New York, Tennessee, and Washington. Affected individuals reported experiencing symptoms similar to botulism, including vision changes, drooping eyelids, difficulty swallowing, dry mouth, slurred speech, difficulty breathing, fatigue, and generalized weakness, the report said.

According to the CDC, four of the nine hospitalized patients required treatment with botulism antitoxin, but the other five people tested negative for botulism.

The CDC warning comes after an announcement on April 8 from the Illinois State Health Departmentopens in a new tab or window that alerted healthcare providers to two cases of patients showing symptoms similar to botulism after receiving botulinum toxin injections or possibly a counterfeit product. Both had received injections from a licensed nurse who was performing work outside her authority.

If patients present with signs and symptoms consistent with botulism, healthcare providers should be alert to the possibility of adverse effects from botulinum toxin injections, the CDC urged. Clinicians should immediately notify their health department for consultation and antitoxin release, the report said. If their local health department cannot be reached, clinicians can contact the CDC clinical botulism service 24/7 at 770-488-7100.

Clinicians should also contact their state or local health departments for guidance on reporting any botulinum toxin-associated adverse effects.

The FDA alert advised clinicians that they should check products for any signs of counterfeiting before use and noted that the counterfeit product can be identified by one or more of the following:

• Outer carton and vial contain lot number C3709C3
• Outer carton displays the active ingredient as "Botulinum Toxin Type A" instead of "OnabotulinumtoxinA"
• Outer carton and vial indicates 150-unit doses, which is not a unit made by AbbVie or Allergan
• Outer carton contains language that is not English

If patients report using or being interested in receiving botulinum toxin injections, clinicians should encourage them to receive treatments only from licensed providers who are properly trained in administering FDA-approved products, preferably in a licensed or accredited healthcare setting. Also, patients who report using or being interested in botulinum toxin injections should be counseled about the risks of botulism and potential adverse events.

Also, healthcare providers and consumers should report adverse events related to the use of any medications, including suspected counterfeit medications, to FDA's MedWatch Safety Information and Adverse Event Reporting Programopens in a new tab or window.

https://www.medpagetoday.com/publichealthpolicy/productalert/109687

Lawmakers Take Up Fallout From Change Healthcare Cyberattack

 Over $1,000 for diabetes test strips? That's what one patient was told he would have to pay during the Change Healthcare cyberattack earlier this year, a lawmaker said at a House Energy & Commerce Health Subcommittee hearing

opens in a new tab or window on Tuesday.

"This left him with the impossible choice of trying to come up with the money to pay for these strips, or potentially face life-threatening complications from his inability to test his blood sugar," said Frank Pallone (D-N.J.), the ranking member of the full committee.

During the hearing, House lawmakers questioned expert witnesses about the February 21 cyberattack, which dragged on for weeksopens in a new tab or window, and discussed potential ways to prevent future attacks like itopens in a new tab or window.

Change Healthcare, a subsidiary of UnitedHealth Group, is the largest clearinghouse for medical claims in the country, reviewing some 15 billion medical claims annually. As a result of the attack, Change Healthcare took three of its key systems offline: claims processing, payment and billing, and eligibility verifications.

Witness John Riggi, national advisor for cybersecurity and risk for the American Hospital Association, noted that the "ransomware blast radius" was far reaching.

For instance, subcommittee chair Brett Guthrie (R-Ky.) reported that one of his constituents -- an independent provider in Bowling Green, Kentucky -- said they lost staff because of an inability to make payroll. And Rep. Kim Schrier, MD (D-Wash.), said a small rural hospital in her district, Kittitas Valley Healthcare, has still only recouped 50% of its March receipts.

It's "critical that we take whatever action is necessary to reduce the risk to our healthcare systems from cyberattacks," said Pallone, noting that the healthcare sector is likely to remain an "attractive target."

Risks of Consolidation

During his opening remarks, Pallone said that no one anticipated that patient access to care and the financial stability of so many providers could be hurt by "one single point of failure," and questioned if the consolidation of health technology companies might pose "unreasonable risks" to the healthcare system. UnitedHealth bought Change Healthcare in 2022 for $13 billionopens in a new tab or window. The Department of Justice (DOJ) attempted to stop the acquisition, but a federal judge allowed the merger to move forwardopens in a new tab or window. The DOJ dropped its appealopens in a new tab or window of the ruling in 2023.

Rep. Larry Bucshon, MD (R-Ind.), also suggested that Congress and the Federal Trade Commission look more closely at healthcare consolidation and integration. "The massive vertical integration in our system ... is not in the best interest of American people," he said.

Greg Garcia, executive director for cybersecurity for the Healthcare and Public Health Sector Coordinating Council, said one recommendation of his council is that any future mergers in the healthcare sector take into account antitrust considerations, such as market concentration, competition, and "the potential for there becoming a single point of failure of either low redundancy or no redundancy that could cause a catastrophic cyberattack."

"If that finding is positive, then that should be very seriously taken into consideration as to whether to approve a merger or some kind of consolidation that could increase cyber risk," Garcia said.

The Blame Game

Rep. Michael Burgess, MD (R-Texas), said what bothered him about the cybersecurity attack was the tendency to blame the victim.

Speaking to witness Adam Bruggeman, MD, an orthopedic surgeon at the Texas Spine Center in San Antonio, Burgess said, "You are the victim in this. This is not your fault. You did not leave the data out on the sidewalk for someone to drift by and pick it up like it was an abandoned wallet."

"You were attacked," Burgess said "The government should be helping you with that. Change Healthcare should be helping you with that."

Burgess asked Bruggeman if Change Healthcare had made any effort to look at a practice's past history of payments, and pre-pay them what they would have typically billed, in order to help those practices stay afloat.

Bruggeman said a fund was established to help practices cope with the "cash crunch," but there were still challenges.

Change Healthcare had visibility into UnitedHealth's claims, but not into Blue Cross, Aetna, or Cigna, for example, and due to the fragmentation of these systems, "there was an inability to provide the right amount of money," Bruggeman said.

He noted that, according to stories that he read online, some practices received "hundreds of thousands of dollars less than what their actual cost was to run their practice and what they were billing."

Asked if it was possible to predict these kinds of incidents and reduce the impact on physicians going forward, Bruggeman said it will be important to study and track the data to identify ways to protect physicians and small rural hospitals.

Garcia pushed back on the idea that physicians were victims of these attacks. He said he agreed that third-party technologies can introduce new vulnerabilities, but that health systems bear some responsibility for assessing third-party services and providers.

"You need to know what you're buying and who you're letting into your network," he said. "Yes, [health systems] are the victim, but if we live in a bad neighborhood, we don't leave our doors unlocked and our windows open."

"And the internet is a bad neighborhood," Garcia added.

Separately, Anna Eshoo (D-Calif.), the ranking member of the subcommittee, asked whether the $1.3 billion in the Biden administration's budget proposal was sufficient to address such attacks.

Riggi said that it was "woefully insufficient" given the 6,000 hospitals that would utilize the funds.

Lastly, Cathy McMorris Rodgers (R-Wash.), chair of the full Energy & Commerce Committee, said she was "disappointed" that UnitedHealth did not make a witness available for the hearing, although a UnitedHealth representative told committee members that the company has committed to testify at a future hearing.

https://www.medpagetoday.com/practicemanagement/informationtechnology/109703

China fuels US fentanyl crisis subsidizing key chemicals, firms tied to drug trafficking: House report

 China has been directly causing the deadly fentanyl crisis ravaging communities across America by giving tax rebates to producers and exporters of key precursor chemicals and doling out grants to companies involved in drug trafficking, according to a shocking congressional report released Tuesday.

The House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party noted in the 64-page document that many of the substances involved in production of the deadly opiate are illegal under Chinese law “and have no known legal use worldwide.”

However, the report says, Beijing continues to provide subsidies “solely for exporting these deadly synthetic narcotics out of China.”

“This policy was in place at least as early as 2018,” the committee said, “and continued during the height of diplomatic furor between the United States and [China] over the massive amounts of illicit fentanyl materials it was sending to America.”

The report cited data from China’s State Taxation Administration, which listed certain exported chemicals as eligible for rebates of up to 13%.

The committee added that the subsidization system “incentivized the export of at least 17 illegal narcotics that are Schedule I controlled substances and have no legitimate purpose.”

The subsidies, the report added, were still in place as of this month.

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China is benefiting strategically and economically from the US fentanyl crisis, the report claimed.AP

Meanwhile, the panel noted, despite having “advanced techno-totalitarian surveillance state in human history,” China has repeatedly looked the other way from the manufacture and export of fentanyl — even giving companies a heads-up when US law enforcement asks for Beijing’s assistance.

The early warnings led to drug-making companies “changing their operational techniques, making it harder to detect and deter their criminal activities,” the committee said, later adding that on the rare occasions the US was able to arrest Chinese drug traffickers, Beijing “not only refused to assist the investigation but also published warnings to the … drug trafficking community to avoid ‘falling into US snares and arrest-entrapment.'”

During one 2018 meeting between federal investigators and their Chinese counterparts about a particular trafficking ring, the report recounted, the Beijing authorities freely admitted their laws had been violated, only to stonewall by claiming that “‘different staff’ handles these types of violations and that they would not be in until the following week.

“Despite the US investigative team offering to change their flights to meet the ‘different staff’ to discuss further cooperation, the [Chinese] senior-most official refused and ended the meeting, stating that they would be in touch for further cooperation.”

“Aside from limited collaboration in 2017,” the report added. “‘Beijing has not followed up on other major US indictments of Chinese nationals on drug trafficking charges.'”

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The House China Committee is a rare bipartisan panel.ZUMAPRESS.com

“The global illicit fentanyl trade has enriched [China] itself, empowered its organized crime assets through lucrative money laundering, and offer [Chinese] elites a means to move a certain amount of their capital abroad,” it went on.

Since President Biden took office in January 2021, more than 200,000 Americans have died from fentanyl, which is increasingly cut into non-opioid drugs including cocaine and into counterfeit prescriptions, killing unwitting users.

“Through its actions, as our report has revealed, the Chinese Communist Party is telling us that it wants more fentanyl entering our country,” said select committee Chairman Rep. Mike Gallagher (R-Wis.) at the top of a Tuesday hearing. “It wants the chaos and devastation that has resulted from the epidemic.”

“Imagine you woke up one morning and heard that a passenger plane carrying over 200 people crashed, killing everyone on board. Imagine that this happened again the next day, and the next. Day after day and year after year. This scale of death seems incomprehensible. And yet, it is the reality that we live in,” Gallagher added.

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Fentanyl is estimated to kill tens of thousands of Americans each year.DEA

“While we knew where fentanyl comes from, until now, we did not know why,” the Republican went on, pointing the finger squarely at Chinese President Xi Jinping’s pursuit of “asymmetric warfare” with the US.

“Xi Jinping has stated that it is the role of the CCP to overthrow the liberal democratic system,” the retiring congressman warned. “One of their generals and leading strategists has even discussed ‘drug warfare that causes disasters in other countries while making huge profits’ as an effective tactic.”

In November, fentanyl emerged as a top priority during Biden’s meeting with Xi on the sidelines of the APEC summit in San Francisco. At the time, China publicly vowed to clamp down on the chemicals used to produce the synthetic opioid.

Biden and Xi also spoke via phone earlier this month for the first time since their November meeting, and discussed their joint efforts to combat fentanyl production, according to the White House.

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The addictive synthetic opioid has wreaked havoc on communities across the country.Anadolu Agency via Getty Images
However, Ray Donovan, a former senior Drug Enforcement Administration official, told the hearing that the November agreement had not changed China’s support for shipping fentanyl to the West, and implored the government to “apply more pressure.”

“Without China’s production and export of fentanyl and fentanyl precursors, there would be no fentanyl crisis in the United States,” agreed former Attorney General Bill Barr, who said Beijing is “knee-deep in actively sponsoring, encouraging, and facilitating the production and export of fentanyl and fentanyl precursors for distribution in the United States.”

The committee recommended that the government convene a task force on opioids, ratchet up sanctions and penalties on fentanyl-related commerce, bolster customs enforcement, and close regulatory gaps.

The US has previously said that China is the primary source of the precursor chemicals synthesized into fentanyl by drug cartels in Mexico. Mexico’s government also has asked China to do more to control shipments of fentanyl to that country.

China, for its part, has said the responsibility lies with the US government to curb domestic demand for opioids.

https://nypost.com/2024/04/16/us-news/china-fueling-us-fentanyl-crisis-by-subsidizing-key-chemicals-enriching-companies-tied-to-drug-trafficking-scathing-house-report/

IMF slams Biden spending as US debt balloons past $34T: ‘Something will have to give’

 The International Monetary Fund sounded the alarm on the Biden administration’s rampant spending as “out of line with what is needed for long-term fiscal stability.”

The latest forecast from the IMF — a Washington-based group tasked with fighting financial crises worldwide — warned that the ballooning national debt and the fiscal deficit threatened to exacerbate sky-high levels of inflation while posing a long-term risk to the global economy.

The IMF noted in its forecast that the US federal budget deficit grew from $1.4 trillion in fiscal 2022 to $1.7 trillion last year.

The debt held by the public, which surpassed $34 trillion, is on course to exceed $45.7 trillion within a decade — which is roughly 114% of the gross domestic product, according to projections by the Congressional Budget Office.

“Something will have to give,” the IMF warned.

The IMF, a financial agency run under the auspices of the United Nations, praised the US economy for its growth.

Despite rampant inflation, the US economy has continued to add jobs while spending and income have been on the rise. In the fourth quarter of last year, GDP rose at an annual rate of 3.3%. In 2023, the US economy added 2.7 million jobs.

Nevertheless, the IMF said that the Biden administration’s spending is cause for concern.

“The exceptional recent performance of the United States is certainly impressive and a major driver of global growth,” the IMF said. “But it reflects strong demand factors as well, including a fiscal stance that is out of line with long-term fiscal sustainability.”

Since entering office, Biden has spent trillions on COVID relief as well as infrastructure. The US has also spent billions in helping Ukraine fight off the Russian invasion.

But the Biden administration said that tax cuts signed into law by former President Donald Trump are to blame for ballooning debt.

“The Trump tax cuts added $2 trillion to the debt with unpaid giveaways skewed to the wealthy and big corporations, and now Congressional Republicans are proposing another $5.5 trillion in tax cuts skewed to the rich, while raising taxes on millions of middle-class families,” Michael Kikukawa, a White House spokesperson, told The Post.

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On Feb. 2, the national debt stood at $32.9 trillion. Since then, it has soared to above $34 trillion.Christopher Sadowski

“President Biden is fighting to lower the deficit by $3 trillion by making the richest Americans and big corporations pay their fair share—all while cutting taxes for the middle class and never raising taxes on households earning less than $400,000.”

The US is an outlier among the major industrial economies. Europe’s economy failed to expand by the end of last year.

The 20 countries that use the euro as a currency have not shown significant growth since the third quarter of 2022 — and even then the economy grew at just 0.5%. The eurozone grew 0.5% for the full year in 2023, while the US grew 2.5%.

China, the world’s second largest economy, said late Monday it grew a surprisingly strong 5.3% despite an ongoing property crisis. Russia, which remains mired in its invasion of Ukraine, has managed to withstand Western sanctions. Its economy is projected to grow at a 3.2% clip.

https://nypost.com/2024/04/16/business/imf-slams-biden-spending-as-us-debt-balloons-past-34-trillion/