'Odds of Heart Attack Six Times Higher With Flu Diagnosis'

 People diagnosed with influenza are six times more likely to have a heart attack within the first week that they test positive for the influenza virus than they are in the year before or the year after, a new study indicates.

This work, led by Annemarijn de Boer, PhD, with the Julius Center for Life Sciences and Primary Care, UMC Utrecht in Utrecht, the Netherlands, comes 5 years after a 2018 study by Canadian researchers found a similar strong connection between flu and heart attack in people hospitalized for heart attacks.

Annemarijn de Boer, PhD

The current findings will be presented by de Boer at the at this year's European Congress of Clinical Microbiology & Infectious Diseases in Copenhagen, Denmark, on April 18.

de Boer's team explains that the connection between influenza and heart attack lies in the influenza virus's ability to increase the stickiness or clotting of blood. That coagulation, along with inflammation from the body's immune response, can weaken fatty plaques in the arteries. If a plaque ruptures, they note, a blood clot can form and cause a heart attack.

"Respiratory infections in general can cause an obstruction like this," de Boer said in an interview.

Researchers Strengthen Analysis With Mortality Data

The aim of this study was to replicate the study by Canadian researchers Kwong and colleagues but strengthen analyses by including mortality data across broader populations. The previous study did not include deaths from heart attack that occurred outside of the hospital.

de Boer used test results from 16 laboratories across the Netherlands (covering around 40% of the population), along with death and hospital records for broader analysis.

In the Netherlands, she said, flu testing and diagnosis is typically done in the hospital, so the patients who were studied were those with severe illness.

"Unfortunately, we were not able to look at flu in the general population," she said.

The laboratories confirmed 26,221 cases of influenza between 2008 and 2019. Among those with influenza, 401 people had at least one myocardial infarction within 1 year of flu diagnosis (a total of 419).

Of the 419, 25 cases were in the first 7 days after flu diagnosis, 217 within the year before diagnosis, and 177 occurred in the year after influenza diagnosis (excluding those in the first 7 days.)

About one third of the people (139 in 401) died of any cause within 1 year of flu diagnosis, the authors write.

The Dutch researchers calculated that study participants were 6.16 times more likely to have a heart attack in the week after an influenza diagnosis than they were in the year before or after. The Canadian researchers found that they were 6.05 times more likely to have a heart attack in that week.

But, when the Dutch researchers excluded the mortality data outside the hospital, just as the Canadian researchers did, they got a much lower but still significant risk number — 2.42 times the risk for heart attack in the first week instead of 6.16 times the risk.

The explanation for the different results when the same parameters for the data were used may come from the fact that testing for flu in outpatient settings is less common in the Netherlands than it is in Canada.

Researchers say the findings show how different the results can be with incomplete data.

de Boer said that it is important for patients and physicians to be aware of the connection and to watch for any heart attack symptoms.

Sherif Mossad, MD

Sherif Mossad, MD, with the Department of Infectious Disease at the Cleveland Clinic in Ohio, told Medscape Medical News, "It is not surprising that the Dutch study found only 2.4 times the increase in heart attacks within one week following flu diagnosis when excluding out-of-hospital deaths, since only a proportion of these deaths are expected to be due to heart attacks."

Implications for Practice

Mossad said that the findings add more robust evidence that the flu is not always a mere inconvenience with a short duration. They also support the necessity of vaccination, he said.

"[This study] raises more awareness about the seriousness and consequences of influenza," he said. "It could precipitate serious, life-threatening problems."

He pointed out that previous research has demonstrated that influenza infection can exacerbate underlying conditions such as chronic obstructive pulmonary disease, liver and kidney disease, and multiple sclerosis.

Mossad noted that the data were collected before the pandemic and said that the numbers of people with influenza having heart attacks in the pandemic might be even higher than what these numbers show.

During the height of the pandemic, he explained, people experiencing chest pain or other symptoms were less likely to come into the hospital for care, most likely due to fear of COVID-19 infection.

Authors and Dr Mossad report no relevant financial relationships.

European Congress of Clinical Microbiology & Infectious Diseases. Presented April 18, 2023. Abstract #4290

https://www.medscape.com/viewarticle/990832

How Medicare and Medicaid Contribute to Budget Deficits

 The steady rise of cumulative federal debt relative to the U.S. economy over the past half-century is a consequence of many decisions, some made by Congress and others by a succession of presidents from both parties. Tax cuts, benefit expansions, responses to financial crises, pandemics, natural disasters, and wars have all been factors. However, acknowledging these many varied contributors to the problem should not prevent the identification of Medicare and Medicaid as particularly important factors. Without their growth, the country’s fiscal challenge would be more manageable than it is, both today and in the future.

The severity of the fiscal challenge posed by these programs was not fully understood when the programs began. There were concerns about costs when President Johnson pressed Congress to approve Medicare and Medicaid in 1965 as part of his ambitious Great Society agenda, but what has occurred has been well beyond the warnings of even those who were the most skeptical about what was being set in motion.
Part of the problem has been a straight underestimation of the spending that would occur based on the provisions included in the original bill. The primary estimates used in 1965 to guide Medicare’s design came from Robert Myers, the long-time chief actuary of the Social Security program. In 1994, he acknowledged that the actual outgo from the Medicare Hospital Insurance (HI) trust fund in 1990 was, after making needed adjustments to ensure comparability, 165 percent higher than the forecast he submitted to the House authors of the original program. Medicare coverage increased the demand for services among the nation’s elderly far more quickly and dramatically than what was predicted, which in turn led the nation’s hospitals and physicians to provide more care to Medicare-eligible patients, and at higher prices, than what was assumed in the official forecast.

An even more important, and also more subtle, factor was the change in the federal government’s budgetary practices and norms that occurred when the programs were enacted and also shortly thereafter.

Up until 1965, there was an expectation that federal programs would be controlled either through the appropriations process, with Congress overseeing annual spending decisions, or through trust funds that would restrict what could be spent to the amounts raised from dedicated tax sources. Either way, there would be political barriers to paying for expenditures from borrowed funds.

In 1965, the primary model for spending authority outside of the annual appropriations process was the Social Security program. Social Security benefits are paid from a permanent appropriation tied to the amount of funding available from two trust funds (for retirement and disability, respectively). The only funds credited to the trust fund are those tied directly to payroll tax receipts (along with a smaller amount of income tax payments) and the investment returns on unspent reserves.

This accounting construct is supposed to ensure that, when considered over a number of years (or perhaps decades), Social Security does not add to total federal borrowing because its spending cannot exceed its dedicated tax receipts, at least not indefinitely. To date, that expectation has been met (although it is in doubt for the future).

Medicare was built upon the same budgetary construct but with a crucial distinction: one of its two trust funds, for Supplementary Medical Insurance (SMI), is partly financed from “general revenue,” not dedicated payments from taxpayers or program participants. In other words, the federal government sends funds to the SMI trust fund that could be obtained from borrowing instead of tax receipts. Indeed, the transfers from the general fund are calculated to ensure the SMI trust fund never becomes depleted.

Perhaps inevitably, once the availability of general funding was made automatic and contingent only on how much medical care costs, the political process and the health care system became ever more reliant on it to cover Medicare’s expenses. In 1970, the annual general fund transfer to SMI was the equivalent of 0.2 percent of GDP. By 2000, it had grown to 0.7 percent, and then, with the addition of the drug benefit to SMI in 2003, it reached 1.4 percent in 2010 and 1.7 percent in 2022. In the most recent Medicare trustees report, the program’s actuaries expect the general fund payment to Medicare to continue to rise relative to GDP and reach 2.8 percent in 2050 and 3.0 percent in 2075.

Medicaid also represented a new way of conducting government business. Along with a few other programs enacted in the same era, it was written as an entitlement program without a source of dedicated tax receipts or even a trust fund. All of its funding comes from the general fund of the Treasury, which in turn gets some funding from borrowing in public markets.

Medicaid is one of the largest of several “mandatory” programs that notionally require funding approval through the annual appropriations process but in practice, are governed by the legal entitlements to benefits their statutes provide to program participants. In other words, Congress can cut Medicaid spending but only by changing its benefit rules and not by imposing a cap on appropriated funds.

With funding that is not constrained by the reluctance of taxpayers to part with their personal resources, Medicare and Medicaid have been given fuel to continue growing on a nearly uninterrupted basis for a half-century. The combined cost of SMI’s annual general fund subsidy and total Medicaid expenses grew from 0.5 percent of GDP in 1970 to 4.1 percent in 2022 – a jump of 3.6 percentage points of GDP. This is a cost the federal government incurs every year. The growing combined expenditures of these programs is an important reason total federal debt grew from 27 percent of GDP to 97 percent over this same period.

It is not possible to secure a dramatic break with the budget practices that finance Medicare and Medicaid because the nation’s entire medical care system has been built up around them. It was also inevitable that the U.S. would devote more resources to health care one way or another (all advanced economies have during this era). The best that can be hoped for at this point is the adoption of reforms that ease the pressure for ever more federal borrowing, which most likely will come from bringing cost discipline to the entire system and not just to Medicare and Medicaid.

James Capretta is a senior fellow at the American Enterprise Institute. He served as associate director for health programs at the Office of Management and Budget in 2003 when adding a Medicare drug benefit to SMI was recommended by the Bush administration and approved by Congress.

https://www.realclearhealth.com/articles/2023/04/17/how_medicare_and_medicaid_contribute_to_budget_deficits_111495.html

Supreme Court Spurns Sanofi Appeal to Revive EpiPen Suit Against Viatris

 The U.S. Supreme Court on Monday declined to hear a bid by Sanofi SA to revive its antitrust lawsuit accusing rival pharmaceutical company Viatris Inc of illegally monopolizing the market with its EpiPen auto-injector, a device used to treat severe allergic reactions.

The justices turned away Sanofi's appeal of a lower court's ruling rejecting the French company's claim that Canonsburg, Pennsylvania-based Viatris had effectively cornered the market through exclusive deals with prescription drug intermediaries.

Sanofi in 2009 acquired the rights to Auvi-Q, an epinephrine auto-injector intended to compete with EpiPen. The company sold the device from 2013 to 2015, when it was recalled over concerns that it failed to deliver its dose of epinephrine. Sanofi terminated its rights to Auvi-Q the next year. Injection of epinephrine is used to treat serious and sometimes life-threatening allergic reactions to foods, medications, bee stings and other causes.

Viatris was formed in 2020 through the merger of Mylan N.V. and Pfizer Inc's Upjohn business. Sanofi sued Mylan in 2017, alleging that it violated antitrust law by giving rebates to pharmacy benefit managers - intermediary companies that maintain the formularies, or lists of covered drugs, used by health plans - in exchange for exclusivity.

Sanofi said in the lawsuit that it lost hundreds of millions of dollars in sales in the $1 billion-plus U.S. epinephrine auto-injector market due to Mylan's conduct and is seeking monetary damages.

A federal judge in Kansas City, Kansas ruled in 2020 in favor of Mylan, finding that Sanofi failed to show how Mylan's negotiating tactics were illegal or harmed consumers. The Denver-based 10th U.S. Circuit Court of Appeals last July agreed, noting that the exclusive contracts in question were "a normal competitive tool within the epinephrine auto-injector industry."

The 10th Circuit added that Sanofi could have competed on those terms, but instead chose initially to market Auvi-Q as a more expensive, premium product. When Sanofi changed course in 2014, one pharmacy benefit manager, CVS Caremark, did switch to Auvi-Q as its only auto-injector on some of its formularies, the panel noted.

The EpiPen has attracted scrutiny for a series of steep price hikes, with the cost of a pair of the devices increasing from $100 in 2008 to $600 in 2016. The price is now nearly $700.

Viatris in February 2022 agreed to pay $264 million to settle a class action lawsuit brought on behalf of consumers and third-party payers like insurers accusing the company of keeping generic competition off the market through an illegal patent settlement.

https://money.usnews.com/investing/news/articles/2023-04-17/us-supreme-court-spurns-sanofi-appeal-to-revive-epipen-suit-against-viatris

US FDA approves Gamida's blood cancer therapy

 The U.S. Food and Drug Administration has approved Gamida Cell Ltd's GMDA.O blood cancer therapy, Omisirge, the health regulator said on Monday.

https://www.nasdaq.com/articles/us-fda-approves-gamidas-blood-cancer-therapy

U.S. charges two with setting up Chinese 'secret police station' in New York

 U.S. law enforcement officials have arrested two New York residents for allegedly operating a Chinese "secret police station" in Manhattan's Chinatown neighborhood, the top federal prosecutor in Brooklyn said in a statement on Monday.

Liu Jianwang, 61, and Chen Jinping, 59, face charges of conspiring to act as an agent of China's government without informing U.S. authorities and obstruction of justice, prosecutors said. They are expected to appear in federal court in Brooklyn federal court later on Monday.

The charges come as the Department of Justice ramps up probes into what they call attempts at "transnational repression" by U.S. adversaries such as China and Iran to intimidate political opponents living in the United States.

"This prosecution reveals the Chinese government's flagrant violation of our nation's sovereignty by establishing a secret police station in the middle of New York City," Breon Peace, the top federal prosecutor in Brooklyn, said in a statement.

Prosecutors said Lu in 2018 sought to persuade an individual considered a fugitive by China to return home, prosecutors said. That individual reported being harassed and threatened, prosecutors said.

China's government in 2022 asked Lu to help locate an individual living in California who was considered a pro-democracy activist, prosecutors said.

Prosecutors said the pair had admitted to the FBI that they deleted their communications with a Chinese government official after learning that they were under investigation.

Federal prosecutors have charged more than a dozen Chinese nationals and others with waging surveillance and harassment campaigns against dissidents living in the United States, including by trying to forcibly repatriate people whom China considered fugitives.

The charges come after FBI Director Christopher Wray told a U.S. Senate committee in November that he was "very concerned" about the presence of such stations in U.S. cities.

He said the Chinese government setting up a police presence in the United States "violates sovereignty" and circumvents law enforcement cooperation.

https://news.yahoo.com/u-charges-two-yorkers-conspiring-163819560.html

aTyr: Preclinical data on aggressive cancer inhibitory treatment at AACR

  aTyr Pharma Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced a poster presentation at the 2023 American Association for Cancer Research (AACR) Annual Meeting, which is being held April 14 – 19, 2023, in Orlando, FL. The abstract is available on the AACR website. The poster will be available on the aTyr website once presented.

The poster presents preclinical findings characterizing the inhibition of tumor growth and therapy resistance in aggressive cancers overexpressing VEGF-C treated with ATYR2810, a fully humanized monoclonal antibody that selectively and functionally blocks neuropilin-2 (NRP2) and VEGF-C signaling by directly binding at the site of the VEGF binding pocket. Treatment with ATYR2810 monotherapy and in combination with chemotherapy in a model of non-small cell lung cancer demonstrated increased tumor growth inhibition and sensitivity to chemotherapy. In a model of clear cell renal cell carcinoma, ATYR2810 in combination with the VEGFR-targeted therapy sunitinib inhibited tumor growth and led to tumor regression in some cases. These data demonstrate the potential therapeutic effects of blocking the NRP2/VEGF-C signaling axis with ATYR2810 on enhanced tumor growth inhibition and sensitivity to chemotherapy and targeted therapy.

https://www.biospace.com/article/releases/atyr-pharma-presents-preclinical-research-demonstrating-treatment-with-atyr2810-inhibits-tumor-growth-and-therapy-resistance-in-highly-aggressive-cancers-at-the-2023-aacr-annual-meeting-/

BioVie: Abstracts from NE3107 Phase 2 Trials Accepted for Presentation at AAN

 BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced data abstracts from its Phase 2 trials evaluating NE7107 in degenerative dementias and Parkinson’s Disease will be presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, to be held virtually and in Boston, MA, April 22-27, 2023.

Details for the presentations are as follows:

New Poster - Multi-Modal Correlation Analyses from a Phase 2, Open-Label Study of NE3107 in Patients with Cognitive Decline Due to Degenerative Dementias

• Presentation date/time: 4/25/23 @8:00-9:00am ET
• Presenter: Joseph Palumbo
• Abstract: https://www.aan.com/MSA/Public/Events/AbstractDetails/54170

Encore Poster - Clinical Outcomes from a Phase 2, Open-Label Study of NE3107 in Patients with Cognitive Decline Due to Degenerative Dementias

• Presentation date/time: 4/25/23 @11:45am-12:45pm ET
• Presenter: Kaya Jordan
• Abstract: https://www.aan.com/MSA/Public/Events/AbstractDetails/54177

Encore Poster - Safety, Tolerability, and Efficacy of NE3107 from a Phase 2, Double-Blind, Placebo-Controlled Study in Levodopa/Carbidopa-Treated Patients with Parkinson's Disease

• Presentation date/time: 4/23/23 @8:00-9:00am ET
• Presenter: Nilab Osman
• Abstract: https://www.aan.com/MSA/Public/Events/AbstractDetails/54740

https://www.biospace.com/article/releases/biovie-announces-data-abstracts-from-ne3107-phase-2-trials-accepted-for-presentation-at-aan-2023/