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Friday, June 14, 2024

'Some Pasteurization Methods May Not Clear H5N1 in Heavily Infected Milk'

 Heating raw milk spiked with H5N1 to temperatures commonly used in commercial pasteurization resulted in a decrease in infectious virus within seconds to minutes, according to a brief study, though some infectious material remained after one standard method.

At a temperature of 63°C (145.4°F), H5N1 virus experimentally added to raw milk decreased from an initial titer of 106 50% tissue-culture infectious doses (TCID50) per mL to undetectable levels within 2 minutes, Vincent Munster, PhD, of the National Institute of Allergy and Infectious Diseases (NIAID) in Hamilton, Montana, and colleagues reported.

Heating milk to 63°C for 30 minutes is one standard method of pasteurizationopens in a new tab or window, and "has a large safety buffer," Munster and co-authors wrote in a correspondence to the New England Journal of Medicineopens in a new tab or window. When heated to 63°C, the half-life of infectious virus was 4.5 seconds (95% CI 3.5-5.8), researchers estimated.

However, when they used another standard pasteurization method -- heating milk to 72°C (161.6°F) for 15 seconds -- they found that small, detectable amounts of infectious virus remained in raw milk samples with initial high viral titers. In samples heated to this higher temperature, virus titers decreased from about 105 to 101 TCID50/ml within 5 seconds. After 20 seconds of heating, no viable virus was detected.

Pasteurization definitely inactivates the H5N1 virus, Munster commented to MedPage Today, but the effect is dose- and duration-dependent. "So a higher dose of virus will take longer to inactivate," he explained.

"The results were generally what we expected," Munster said, noting that his lab had previously done experimental studies on inactivation of MERS-CoV and SARS-CoV-2, as well. "This is the first time we have been doing this with H5N1, but the virus behaves similarly," to other viruses they have tested.

In a press releaseopens in a new tab or window from NIAID, the authors stressed that their findings "reflect experimental conditions in a laboratory setting and are not identical to large-scale industrial pasteurization processes for raw milk."

"The next step, which the USDA [U.S. Department of Agriculture] and FDA are working on, is performing similar experiments with actual industrial pasteurization equipment and mimic the complete process faithfully," Munster said. The study of the effects of pasteurization on the virus in other dairy products besides milk is also needed, the authors wrote.

Gastrointestinal infections with H5N1 have occurred in several species, but it is unknown whether ingesting live H5N1 in raw milk could cause infections in humans or how much would be needed, they pointed out.

An outbreak of H5N1 among dairy cows in Texas was first reported in March 2024. To date, at least 90 cattle herds across 12 statesopens in a new tab or window have been affected, with three human infectionsopens in a new tab or window detected in dairy farm workers. Since 2020, H5N1 clade 2.3.4.4b subtype virusesopens in a new tab or window have spread widely among wild birds worldwide, resulting in outbreaks in poultry and other animals. Recently, the clade 2.3.4.4b viruses were identified in dairy cows and in unpasteurized milkopens in a new tab or window in multiple U.S. states, as well as in cats.

"I think it's important that the public is aware of the current situation with H5N1 in dairy cattle," Munster stressed. At the moment, the direct risk for humans appears to be low, he said, "but this virus already has had devastating effects on wildlife. It needs a true One Healthopens in a new tab or window approach to try to get this under control and minimize the impact on wildlife and production animals."

Munster and his fellow researchers at NIAID's Rocky Mountain Laboratories isolated H5N1 (clade 2.3.4.4b) from the lungs of a dead mountain lion in Montana. They mixed viral isolates with raw, unpasteurized cow milk samples and heat-treated the milk at 63℃ and 72℃ for different periods of time. The samples were then cell-cultured.

H5N1 genome copies were quantified using quantitative reverse-transcriptase-polymerase-chain-reaction assay to determine the amounts of live virus remaining at different time periods. Since the study relied on raw milk samples spiked with H5N1 virus, raw milk from H5N1-infected cows may have a different composition or contain cell-associated virus that may impact the effects of heat, the authors noted.

Disclosures

Munster and study co-authors reported no relevant conflicts of interest.

Primary Source

New England Journal of Medicine

Source Reference: opens in a new tab or windowKaiser F, et al "Inactivation of avian influenza A (H5N1) virus in raw milk at 63°C and 72°C" N Engl J Med 2024; DOI: 10.1056/NEJMc2405488.


https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/110661

Macron Has Gambled... And Lost

By Elwin de Groot, Head of Macro Strategy at Rabobank

We still have one more day to go in the European session before the weekend, but the week in review is already showing to be one of quick decisions, where the bond market was ‘saved’ by the US inflation data and where Macron may have asked for a Papal blessing. But whether that turns out to be sufficient remains to be seen.

Macron has gambled... and lost? According to the latest polls, only 40% of Macron’s MPs would gather enough support to even qualify for a second round of run-off votes. In a surprise move, the French president announced elections last Sunday. Macron may have acted quickly after the results of the European Parliament elections in the hope that he could ride a fear-inspired wave of solidarity that could stop Marine Le Pen’s National Rally in its tracks. However, that move could backfire pretty badly.

According to an Elabe/Les Echos survey, Macron’s approval rating fell to its lowest level in 5.5 years. Macron has made an appeal on voters and the more moderate political parties on both the left and the right to not succumb to the “fever of the extremes”, but it remains to be seen whether his strategy will succeed.

Left-wing parties have equally quickly decided to unite, with a joint programme and a joint list of candidates for the Greens, Socialists, Communists and France Unbowed. The Socialist Party issued a statement yesterday saying that “There was an expectation of union expressed”; but obviously not the unity that Macron was looking for. This quick decision may just undercut Macron’s. It means that the president’s centrist MPs could be squeezed out of parliament by their competition from the left and right side of the field.

Fever of the centre? Finance Minister Le Maire predicted earlier this week that France would face a debt crisis if the National Rally should come to power. This suggests that Macron’s strategy is first and foremost one of sowing fear, and that things have to get worse before they get better. But there seems very little time for that second leg of Macron’s strategy: to get better. Sometimes quick decisions are not always the best decisions.

Macron’s European peers seemed bewildered at the G7 meeting in Italy. According to the news wires Macron only met with Canada’s Trudeau, as well as the leaders of Algeria, India, and Brazil. And with the Pope. You’d wonder if he asked for a little prayer or perhaps a Papal blessing.

The political uncertainty in France seems to have turned into a classic risk-off sentiment. The search for safe havens were one of the reasons that the yield on 10y Bunds declined 6bp yesterday. Meanwhile, the spread between 10y French and German bond yields has widened to the highest level since April 2017. Alongside, the euro dropped below 1.073 and European equities were in the red (Eurostoxx 50 -2%). Prayer or blessing, it definitely did not reassure investors.

But safe-haven assets in both the US and Germany also found some support in the better-than-expected inflation data. Both the headline and core US PPI inflation were significantly lower than expected, strengthening the view that inflationary pressures have finally started to ease. The yield on 2y Treasury notes of fell the lowest level since 4 April, despite the Fed adjusting its dot-plot to reflect one instead of three rate cuts for this year and despite Powell’s reluctance to embrace the most recent CPI report.

More quick decisions. In any case, the prospect of further backlashes after the French elections, political uncertainty in Europe, and a possible Trump re-election are perhaps forcing more quick decisions.

G7 leaders agree to provide a $50 billion loan to Ukraine. The agreement was reached on the first day of the G7 meeting in Italy. The G7 leaders quickly agreed to the loan that is backed by frozen Russian assets. The proceeds on these assets (estimated at some $260 billion in Europe) will be used to pay off an upfront loan to Ukraine. As AP news notes, member states may treat this differently according to national preference/regulations. But the lenders do of course bear the risk that those proceeds would stop if a peace agreement is reached and the Russian assets are unfrozen in the future.

The EU announced additional tariffs on Chinese EVs. It’s another quick decision after the investigation into unfair state subsidies was completed, and it will enter into force with little delay. The EU announced additional tariffs on Chinese EVs ranging from 17 to 38% this week, which will take effect on July 4.

The Germans seem to be hopeful that there is still wiggling room to negotiate with China before the tariff is hiked, but France’s Le Maire applauded the European Commission’s decision to increase import duties on Chinese cars: “It’s a first decision that I hope will be followed by others, notably on solar panels, and on other Chinese over-capacities.” However, as my colleague quipped yesterday, imposing tariffs on Chinese solar panels is only a decade too late. Still, it shows that the French government is ready to “re-establish the balance of power with China.”

That European industry is still struggling was underscored by the data: Eurozone industry output fell 0.1% in April. Although it wasn’t a big decline it was still weaker than expected (+0.2% m/m). Together with downward revisions in earlier data the annual growth rate fell to -3% y/y. That is still a firm 'recession' indication and underscores that the economic recovery in the Eurozone is still a wobbly one, weighed down by structural issues in the manufacturing/export sector and weakness of demand from China (China’s imports from Germany, for example, were down 14% y/y in May after 0% in April).

The Bank of Japan needs a little more time for an exit strategy. The overnight call rate was left unchanged at 0.0% to 0.1%. And policymakers voted to continue their current asset purchases until the July meeting, despite Governor Ueda’s earlier indications that a reduction in the bond buying programmes may be due. The central bank will come with a plan for reducing its bond purchases over the coming 1 to 2 years at their next meeting.

In his press conference, Ueda stated that the reduction in bond purchases will be substantial. But not all decisions can be quick. The central bank will be mindful of the potential market disruptions if policymakers move too hastily. The Bank will not want to inject undue volatility into the JGB market given the potential impact on the balance sheets of Japan’s large insurers and in view of its own huge holdings of domestic bonds. Yet, moving slowly will continue to weigh on the currency. The market had anticipated some adjustments today, so the postponing the decision to next month caused some further weakness in JPY. USD/JPY rose above 158.

https://www.zerohedge.com/economics/macron-has-gambled-and-lost

Tattoos Associated With Increased Lymphoma Risk, And Size Doesn’t Matter: Study

 by George Citroner via The Epoch Times (emphasis ours),

That tattoo you’ve been dreaming of to express your individuality? It could come with a price.

A new study finds the ink used in creating popular body art contains toxic ingredients linked to a higher risk of lymphoma, cancer that begins in germ-fighting lymphatic system. Having just a single tattoo seems to raise your odds.

Tattoos Increase Cancer Risk by 21 Percent

Tattoos have grown increasingly popular as a means of self-expression. Around 32 percent of Americans have at least one tattoo, and an estimated 22 percent have multiple.

However, as tattoos become more widespread, so too has the incidence of malignant lymphoma—increasing 3 percent to 4 percent over the past 40 years. Recent research from Lund University in Sweden, published in The Lancet’s eClinicalMedicine, suggests a potential connection.

The study analyzed data from nearly 12,000 people aged 20 to 60, matched with a control group of the same age and sex without lymphoma. Participants completed questionnaires about lifestyle factors, including tattoos. Researchers found that those with tattoos were more likely to develop malignant lymphoma compared to those without tattoos.

People with tattoos had a 21 percent higher risk of developing any type of lymphoma after adjusting for other factors.

The lymphoma risk was highest (81 percent higher) for those who got their first tattoo less than two years before being diagnosed. The risk decreased for those who had gotten their tattoos between three and 10 years ago but increased again (19 percent higher risk) for those who had gotten their first tattoo 11 or more years ago.

Size Doesn’t Seem to Matter

A larger total tattoo size did not seem to increase the risk further.

“We do not yet know why this was the case,” Christel Nielsen, who led the study, said in a press release. ”One can only speculate that a tattoo, regardless of size, triggers a low-grade inflammation in the body, which in turn can trigger cancer.”

The picture is thus more complex than initially thought, she noted.

The research is the first to investigate tattoos as a risk factor for cancer in the lymphatic system, Ms. Nielsen told The Epoch Times. Further studies investigating potential links between tattoos and other cancer types are underway.

While acknowledging that tattoos will likely remain popular forms of self-expression, Ms. Nielsen said, “It is important to make people aware that tattoos may have adverse health effects and that you should seek medical care if you have complaints that you associate with a tattoo.”

Growing Evidence for Tattoo-Related Cancer Risks

“We know that tattoo ink often contains hazardous chemicals and that it is deposited in lymph nodes,” Ms. Nielsen told The Epoch Times. The immune system always “attempts to clean out the ink particles that it perceives as something foreign that should not be there,” she added.

A 2022 study published in Toxicology and Industrial Health identified toxic substances in tattoo inks and warned that they “could pose toxicological risks to human health.”

Ms. Nielsen’s research adds to previous work linking tattoos to increased cancer risk. A study presented at the 2023 American Association for Cancer Research Annual Meeting identified a potential link between having three or more large tattoos and higher risks of blood cancers, myeloid neoplasms (bone marrow cancers), and lymphoma.

The findings showed that compared to never receiving a tattoo, getting a first tattoo before age 20 was associated with elevated myeloid neoplasm risk, while receiving a first tattoo at age 20 or older was linked to higher lymphoma risk. However, the authors cautioned that these estimates were “imprecise.”

Certain ink colors have been tied to skin cancer risks. A 2021 case series found that black and red inks were associated with increased risks of deadly skin cancers like melanoma, basal cell carcinoma (the most common type), and dermatofibrosarcoma protuberans, a rare, slow-growing soft tissue tumor.

https://www.zerohedge.com/medical/tattoos-associated-increased-lymphoma-risk-and-size-doesnt-matter-study

"Alt-Protein": Pentagon Contractor Wants To Feed US Troops Lab-Grown Meat To "Reduce CO2 Footprint"

 A Pentagon contractor that has received more than $500 million from the Defense Department wants to produce lab-grown meat for America's soldiers in order to "reduce the CO2 footprint" at Defense Department outposts, the Free Beacon reports.

BioMADE, a public-private DoD contractor, "is a Manufacturing Innovation Institute (MII) sponsored by the U.S. Department of Defense (DoD) with a vision to build a sustainable, domestic, end-to-end bioindustrial manufacturing ecosystem," according to a project overview posted last month. It is seeking proposals to develop "innovations in food production that reduce the CO2 footprint of food production at ... DoD operational environments," which include "novel cell culture methods suitable for the production of cultivated meat/protein," aka lab grown meat.

This type of meat is grown in a lab from animal cells with the aid of other chemicals, and has emerged as a flashpoint in debates about the efficacy and morality of manufacturing meat products without slaughtering animals.

BioMADE—which earlier this year received a $450 million infusion of taxpayer cash—maintains that lab-grown food products will reduce the Pentagon’s carbon footprint, a priority for the American military as it pursues a Biden administration-mandate to address climate change and other cultural issues that critics describe as "woke." -Free Beacon

"Innovations in food production that reduce the CO2 footprint of food production at and/or transport to DoD operational environments are solicited," the company said in an informational document. "These could include, but are not limited to, production of nutrient-dense military rations via fermentation processes, utilizing one carbon molecule (C1) feedstocks for food production, and novel cell culture methods suitable for the production of cultivated meat/protein."

The company is also soliciting proposals for "processes that convert greenhouse gasses," as well as "projects that develop bioproducts useful in mitigating the negative environmental impacts either regionally or globally," including "bioproducts that can be used to prevent or slow coastal erosion

The project has fallen under heavy scrutiny from critics, who say that US troops should not be used as guinea pigs for experimental food.

"Taxpayer dollars should not be used to fund the lab-grown meat sector," said Jack Hubbard, executive director at the Center for the Environment and Welfare, a consumer group that analyzes emerging markets such as bioengineered meat. "Our troops deserve better than to be served lab-grown meat, produced in bioreactors with immortalized cells and chemicals."

"Unfortunately, this effort is being driven by an agenda that is political and anti-farmer. Our soldiers should never be used as guinea pigs," he continued.

The Pentagon and its outside partners, as part of its push to fund "alt-protein projects," made up to $2 million available for such projects, according to the publication Alt-Meat.

Supporters of these efforts say U.S. national security hinges on addressing global change and pursuing new technologies that enable products like lab grown meat. -Free Beacon

According to former DoD official Matt Spence in 2021, "One of the most immediate, politically feasible, and high-impact ways to do this [address climate change] is for the U.S. government to invest in and accelerate alternative ways to produce meat."

That said, UC Davis published a report last year suggesting that "lab-grown meat’s carbon footprint [is] potentially worse than retail beef."

"If companies are having to purify growth media to pharmaceutical levels, it uses more resources, which then increases global warming potential," said lead author, Derrick Risner of the college's Department of Food Science and Technology. "If this product continues to be produced using the ‘pharma’ approach, it’s going to be worse for the environment and more expensive than conventional beef production."

"Our findings suggest that cultured meat is not inherently better for the environment than conventional beef. It’s not a panacea," said corresponding author Edward Spang, an associate professor in the Department of Food Science and Technology. "It’s possible we could reduce its environmental impact in the future, but it will require significant technical advancement to simultaneously increase the performance and decrease the cost of the cell culture media."


DOJ declines to prosecute Garland after congressional contempt vote

 The Justice Department (DOJ) issued a determination Friday that Attorney General Merrick Garland committed no crime in failing to meet the demand of House Republicans who subpoenaed audio of President Biden’s conversation with special counsel Robert Hur. 

The determination is in line with a Wednesday memo from the DOJ’s Office of Legal Counsel that stated Biden’s claim of executive privilege over the tapes protected Garland from prosecution. That memo was drafted hours before all but one House Republican approved a resolution to hold Garland in contempt of Congress. 

However, such resolutions act as a referral to the Justice Department, which must then determine whether grounds exist for criminal charges — in this case with the DOJ strongly rebuffing the request in a three-page letter. 

The DOJ under administrations of both parties has repeatedly declined to prosecute several attorneys general or other officials who have not turned materials over to Congress, the department noted in a letter to House Speaker Mike Johnson (R-La.).

“Consistent with this longstanding position and uniform practice, the Department has determined that the responses by Attorney General Garland to the subpoenas issued by the Committees did not constitute a crime, and accordingly the Department will not bring the congressional contempt citation before a grand jury or take any other action to prosecute the Attorney General,” Carlos Uriarte, the DOJ’s head of legislative affairs, wrote in the letter. 

Republicans already have the transcript of the conversation, and while they’d publicly sought to connect the tapes to their impeachment probe, the transcript makes clear no items they marked as important to their investigation were discussed. 

Garland after Wednesday’s vote had accused Republicans of using contempt as a partisan tool. 

“It is deeply disappointing that this House of Representatives has turned a serious congressional authority into a partisan weapon. Today’s vote disregards the constitutional separation of powers, the Justice Department’s need to protect its investigations, and the substantial amount of information we have provided to the Committees,” he said. 

The refusal is likely to tee up additional action from House Republicans. 

Rep. Anna Paulina Luna (R-Fla.) said she would file a privileged motion to take up a previously filed inherent contempt resolution – legislation that if approved would greenlight the House sergeant at arms to bring Garland to the House to force him to turn over subpoenaed items.

“It hasn’t been done since the early 1900s and was actually a pretty common practice for when people blatantly ignored and disrespected the authority of the House Representatives. So we hope that Garland does the right thing and we hope that the DOJ does the right thing,” she told The Hill ahead of Wednesday’s vote. 

DOJ on Friday stressed the numerous documents turned over in response to the subpoena, including the transcript and two classified documents. They noted Hur himself also testified for hours about his investigation. 

Leading into the vote, Republicans suggested that because Biden had shared the transcript he had little ground for holding back the audio.  

“The president has waived any executive privilege over these audio recordings by releasing a transcript of the entire interview to the public,” House Oversight and Accountability Chair James Comer (R-Ky.) said during a House Rules Committee meeting Tuesday.

But the 57-page memo from the department’s Office of Legal Counsel rejected that argument. 

“Because the committees have the transcripts of the special counsel’s interviews, the needs the committees have articulated for the recordings are plainly insufficient to overcome a privilege claim grounded in these important separation of powers concerns,” according to the memo.

“The audio recording will not reveal any information relevant to the committees’ stated needs that is not available in the transcripts.”

J.P. Morgan Raises Over $500M for First Biotech Venture Capital Fund

 J.P. Morgan Private Capital announced Thursday that it has closed its first biotechnology-focused capital fund, securing over $500 million from various backers.

The fund, called 270 Life Sciences Private Capital Fund I, attracted “strong support” from investors including family offices, corporate partners, institutional allocators and “high net worth individuals,” according to the announcement. JPMorgan Chase & Co. also contributed.

The fund will focus its investments on private biotechnology companies and will be agnostic about the stage, modality, geography and therapeutic area of the investment. However, in an interview with Endpoints News, Stephen Squinto, chief investment officer and managing partner of J.P. Morgan Life Sciences Private Capital, said that the fund wants to make 20 to 25 investments primarily with early-stage companies.

Early investments will target biotechs in the cardiometabolic disease, immunology, oncology and genetic medicine spaces. The fund is led by Squinto and managing partner Gaurav Gupta.

“As investors and company builders, we are strongly positioned at J.P. Morgan Private Capital to identify and support highly innovative companies that can shape the future of how patients are treated. Our mission is to capitalize companies and utilize our collective experience to guide them towards successful outcomes and mentor a new generation of biotechnology founders and executives,” Squinto said in a statement.

J.P. Morgan has been actively building its presence in the biotech funding space over the past few years. In 2022, J.P. Morgan Asset Management launched the life science-focused private equity team to support early and growth-stage biotechs. In April 2024, J.P. Morgan Asset Management’s Private Capital Division announced that it had raised a $100 million Series A round for Enlaza Therapeutics, with the funding aimed at advancing a covalent biological platform and pipeline for novel protein drugs.

Other VC firms have been committing to sizable funds to invest more heavily in life sciences and biotech. In January 2024, Goldman Sachs Asset Management announced it closed its first $650 million life science fund called West Street Life Sciences I. Initially, the fund committed around $90 million to five biotechs including MOMA Therapeutics, Nested Therapeutics, TORL Biotherapeutics, Septerna and Rapport Therapeutics.

On Wednesday, Foresite Capital closed its sixth fund with $900 million in commitments to invest in growth-oriented biotechs in precision therapeutics, healthcare delivery and life science infrastructure.

https://www.biospace.com/article/j-p-morgan-raises-over-500m-for-first-biotech-vc-fund-/

Telix Abandons IPO Plans at Last Minute, Cites ‘Current Market Conditions’

 Telix Pharmaceuticals on Friday announced that the company voluntarily withdrew its previously announced $200 million-plus initial public offering, shortly before it was set to debut on the Nasdaq.

The radiopharma developer in Friday’s announcement pointed to the “current market conditions” as its reason for pulling its initial public offering (IPO). “Given the proposed Nasdaq listing was not predicated on the need to raise capital, Telix’s management and Board of Directors have decided not to move forward with the transaction at the terms provided,” Telix said in a statement.

“The company did not feel that the proposed discounts were aligned with its duty to its existing shareholders,” according to Telix.

Based in Melbourne, Australia, Telix announced its IPO last week with plans to put up for sale 17 million American Depository Shares and targeting an overall offering value of more than $232 million, according to its filing. The biotech was expected to trade on the Nasdaq on Friday under the ticker symbol TLX. In anticipation of its U.S. debut, Telix asked the Australian Stock Exchange (ASX) to halt trading of its stocks on Thursday.

Following its IPO withdrawal, Telix expected to resume trading on the ASX on Friday.

Christian Behrenbruch, Telix managing director and group CEO, said in a statement that Friday’s withdrawal “is not our desired outcome.” However, the company’s “strategic objectives must align with our duty to existing shareholders,” he said.

Telix is advancing a pipeline of targeted radiation products using its core technology that combines a targeting moiety—such as an antibody or a small molecule drug—with a radioactive isotope payload. The molecules arising from this platform are meant for therapeutic or imaging applications.

Telix’s lead candidate is TLX591, a radio antibody-drug conjugate (rADC) that targets the PSMA protein, allowing the investigational therapy to target prostate cancer. TLX591 is currently being studied in a Phase II/III trial. The Australian biotech is also advancing TLX250, another rADC that is being developed for metastatic kidney cancer. Proceeds from Friday’s IPO were supposed to help Telix run a Phase III study for TLX250.

Despite dropping its IPO plans in the U.S., Telix contends that its performance and prospects “remain strong,” according to its announcement. Since January 2024, the company said it has hit “a number of commercially significant milestones” including positive readouts and two product approval submissions to the FDA.

The company believes its balance sheet is enough to deliver on its key corporate objectives including continued growth in the U.S., particularly for its commercial team, to support the launch of certain products. Telix maintains it will also still be able to continue the clinical development of its pipeline assets.

https://www.biospace.com/article/telix-abandons-ipo-plans-at-last-minute-cites-terms-under-current-market-conditions-/