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Wednesday, December 13, 2023

These Amendments Would Open The Door To A Dangerous Global Health Bureaucracy

 by David Thunder via The Brownstone Institute,

The Covid pandemic gave the World Health Organisation and its partners unprecedented visibility and a tremendous amount of “soft” power to shape public health law and policies across the world. Over the past year or so, the WHO has been pushing hard to consolidate and expand its power to declare and manage public health emergencies on a global scale.

The primary instruments for this consolidation are a WHO Pandemic Accord and a series of far-reaching amendments to existing International Health Regulations (IHR). The target date for finalising both the IHR Amendments and the new Pandemic Accord is May 2024.

The net effect of the proposed text for the pandemic accord and the proposed amendments to the International Health Regulations, would be to create a legal and financial basis for the emergence of an elaborate, internationally coordinated bio-surveillance regime and significantly strengthen the authority of the World Health Organisation to direct and coordinate the international response to global and regional public health threats.

It is not entirely clear why the WHO decided to negotiate a separate pandemic treaty that overlaps in significant ways with the proposed IHR amendments. In any case, most of the far-reaching changes to global health regulations are already contained within the IHR amendments, so that is what we will focus on here.

Even if the WHO failed to get a new pandemic treaty passed, the proposed amendments to International Health Regulations would be sufficient by themselves to confer unprecedented power on the WHO to direct international health and vaccination policies in circumstances deemed by the WHO to be a “public health emergency of international concern.”

The WHO wants the IHR amendments to be finalised on time for next year’s World Health Assembly, scheduled for 27 May – 1 June 2024. Assuming the amendments are approved by a simple majority of the delegates, they will be considered fully ratified 12 months after that, unless heads of State formally reject them within the designated opt-out period, which has been reduced from 18 to 10 months.

If ratified, they will come into effect two years after their announcement at the May 2024 World Health Assembly (i.e., around June 2026), as stipulated in the annex to Amendments to the International Health Regulations (2005) agreed to on 28th May 2022.

In other words, revisions to the International Health Regulations will pass by default rather than by formal acceptance by heads of State. The silence of heads of State will be construed as consent. This makes it all the easier for the revised IHR to pass without proper legislative scrutiny and without a public debate in the States that are subject to the new legal framework.

To get a flavour of how these changes in international law are likely to impact the policies of governments and citizens’ lives more broadly, it is sufficient to review a selection of the proposed amendments. While we do not know which of the amendments will survive the negotiation process, the direction of travel is alarming.

Taken together, these amendments to International Health Regulations would push us in the direction of a global public health bureaucracy with limited democratic accountability, glaring conflicts of interest, and significant potential for systematic harm to the health and liberties of citizens.

The amendments discussed below are drawn from a 46-page document hosted on the WHO webpage entitled “Article-by-Article Compilation of Proposed Amendments to the International Health Regulations (2005) submitted in accordance with decision WHA75(9) (2022).” Because these changes are being negotiated largely outside the frame of national electoral politics, the average citizens is barely aware of them.

Should these amendments come into force, States will be bound by international law, in the event of a public health emergency (as defined by WHO) to follow the playbook of health policies determined by the WHO and its “emergency committee” of “experts,” leaving far less scope for national parliaments and governments to set policies that diverge from WHO recommendations.

Insofar as national States formally consent to the IHR amendments, their sovereignty would remain intact, from a legal perspective. But insofar as they are binding themselves to dance to the tune of political actors outside the scope of national politics, they would clearly lose their freedom to set their own policies in this domain, and health policy “gurus,” instead of representing their fellow citizens, would represent a global health regime transcending national politics and operating above national law.

Under a globally coordinated public health regime, activated by an international public health emergency declared by the WHO, citizens would be vulnerable to errors committed by WHO-nominated “experts” sitting in Geneva or New York, errors which could replicate themselves through a global health system with little resistance from national governments.

Citizens have a right to know that the amended regulations as they stand would give unprecedented power to a WHO-led global health regime and, by implication, its most influential financial and political stakeholders like the World Economic Forum, the World Bank, and the Bill & Melinda Gates Foundation, all of which are largely beyond the reach of national voters and legislators.

There are dozens of proposed amendments to the 2005 International Health Regulations. Here, I will highlight eight changes that are of special concern because of their implications for the independence of national health regimes and for the rights of citizens:

States Bind Themselves to Follow WHO’s Advice as “The Guidance and Coordinating Authority” During an International Public Health Emergency

One of the amendments to IHR (International Health Regulations) reads, “States Parties recognize WHO as the guidance and coordinating authority of international public health response during public health Emergency of International Concern and undertake to follow WHO’s recommendations in their international public health responses.” Like many other treaty “undertakings,” the means for other parties to IHR to enforce this “undertaking” are limited.

Nevertheless, States party to the new regulations would be legally binding themselves to adhere to WHO recommendations and may lose credibility or suffer politically for failing to follow through on their international treaty commitments. This may seem “toothless” to some, but the reality is that this sort of “soft power” is what drives a good deal of compliance with international law.

Removal of “Non-Binding” Language

In the previous version of Article 1, WHO “recommendations” were defined as “non-binding advice.” In the new version, they are defined simply as “advice.” The only reasonable interpretation of this change is that the author wished to remove the impression that States were at liberty to disregard WHO recommendations. Insofar as signatories do “undertake to follow WHO’s recommendations in their international public health responses,” it would indeed appear that such “advice” becomes legally “binding” under the new regulations, making it legally difficult for States to dissent from WHO recommendations.

Removal of Reference to “Dignity, Human Rights and Fundamental Freedoms”

One of the most extraordinary and disturbing aspects of the proposed amendments to IHR is the removal of an important clause requiring that the implementation of the regulations be “with full respect for the dignity, human rights and fundamental freedoms of persons.”

In its place, the new clause reads that the implementation of the regulations shall be “based on the principles of equity, inclusivity, coherence and in accordance with their (the?) common but differentiated responsibilities of the States Parties, taking into consideration their social and economic development.” It is hard to know how any sane and responsible adult could justify removing “dignity, human rights, and fundamental freedoms” from International Health Regulations.

Expansion of Scope of International Health Regulations

In the revised version of Article 2, the scope of IHR includes not only public health risks, but “all risks with a potential to impact public health.” Under this amendment, International Health Regulations, and their main coordinating body, the WHO, would be concerned not only with public health risks, but with every conceivable societal risk that might “impact” public health. Workplace stress? Vaccine hesitancy? Disinformation? Misinformation? Availability of pharmaceutical products? Low GDP? The basis for WHO intervention and guidance could be expanded indefinitely.

Consolidation of a Global Health Bureaucracy

Each State should nominate a “National IHR Focal Point” for “the implementation of health measures under these regulations.” These “focal points” could avail of WHO “capacity building” and “technical assistance.” IHR Focal Points, presumably manned by unelected bureaucrats and “experts,” would be essentially nodes in a new WHO-led global health bureaucracy.

Other important aspects of this new global health bureaucracy would be the WHO’s role in developing global “allocation plans for health products” (including vaccines), the WHO’s role as an information hub for expanded disease surveillance and research units across the world, and the WHO’s role as a a lead player in an international network of actors devoted to combatting “false and unreliable information” about public health events and anti-epidemic measures.

Expansion of WHO Emergency Powers

Under the revised regulations, the Director-General of the World Health Organisation, “based on the opinion/advice of the Emergency Committee,” may designate an event as “having the potential to develop into a public health emergency of international concern, (and) communicate this and the recommended measures to State parties…” The introduction of the concept of a “potential” public health emergency, along with the idea of an “intermediate” emergency, also to be found among the proposed amendments, gives the WHO much wider leeway to set in motion emergency protocols and recommendations. For who knows what a “potential” or “intermediate” emergency amounts to?

Entrenchment and Legitimation of an International Bio-Surveillance Regime

The old Article 23, “Health Measures on arrival and departure,” authorises States to require that travellers produce certain medical credentials prior to travel, including “a non-invasive medical examination which is the least intrusive examination that could achieve the public health objective.” In the new version of Article 23, travellers may be required to produce “documents containing information…on a laboratory test for a pathogen and/or information on vaccination against a disease.”

These documents may include WHO-validated digital health certificates. Essentially, this reaffirms and legally validates the vaccine passport regime that imposed prohibitive testing costs on unvaccinated citizens in 2021-23, and resulted in thousands and probably tens of thousands of people vaccinating just for the convenience of travelling, rather than based on health considerations.

Global Initiatives for Combating “False and Unreliable Information”

Both WHO and States bound by IHR, under the revised draft of IHR, “shall collaborate” in “countering the dissemination of false and unreliable information about public health events, preventive and anti-epidemic measures and activities in the media, social networks, and other ways of disseminating such information.” Clearly the misinformation/disinformation amendments entail a propaganda and censorship regime.

There is no other plausible way to interpret “countering the dissemination of false and unreliable information,” and this is exactly how anti-disinformation measures have been interpreted since the Covid pandemic was announced in 2020 – measures, it may be added, that suppressed sound scientific contributions concerning vaccine risks, lab origins of the novel coronavirus, and efficacy of community masking.

The joint effect of these and other proposed changes to International Health Regulations would be to enthrone the WHO and its director-general at the head of an elaborate global health bureaucracy beholden to the special interests of WHO patrons, a bureaucracy that would be operated largely with the cooperation of State officials and agencies implementing “advice” and “recommendations” issued by the WHO, which State parties have legally undertaken to follow.

While it is true that international treaties cannot be coercively enforced, this does not mean that international law is inconsequential. Under the newly amended regulations, a highly centralised public health bureaucracy would be propped up by lavish funding mechanisms and protected by international law. A bureaucracy of this sort would inevitably become entrenched and intertwined with national bureaucracies, and would become an important element of the policymaking architecture of pandemic planning and responses.

Though national States could, theoretically, bypass this bureaucracy and renege on their legal undertakings under IHR, taking a different path to that recommended by WHO, this would be rather strange, given that they themselves would have both approved and financed the regime they are boycotting.

In the face of opposition from one or more signatory States, the WHO and its partners could pressure such a State into complying with its edicts by shaming it into upholding its legal commitments, or else other States may reprimand “renegade” states for putting international health in jeopardy, and apply political, financial and diplomatic pressure to secure compliance. Thus, while IHR would operate upon State officials in a softer way than national, police-backed regulations, it would certainly not be powerless or politically inconsequential.

The impact of the new global health bureaucracy on the lives of ordinary citizens may be quite dramatic: it would erect a global censorship regime legitimated by international law, making challenges to officially sanctioned information harder than ever; and it would make international public health responses even more slavishly dependent on WHO directives than they were before, discouraging independent, dissenting responses such as that of Sweden during the Covid pandemic.

Last but not least, the new global health bureaucracy would put the fate of ordinary citizens – our national and international mobility, our right to informed consent to medication, our bodily integrity, and ultimately, our health – in the hands of public health officials acting in lockstep with WHO “recommendations.”

Apart from the fact that policy diversification and experimentation is essential to a robust healthcare system, and is crushed by a highly centralised response to health emergencies, the WHO is already riddled with internal conflicts of interest and a track record of catastrophically unsound judgments, making them singularly unqualified to reliably identify a global health emergency or coordinate the response to it.

To start with, the WHO’s income stream depends on individuals like Bill Gates who have significant financial stakes in the pharmaceutical industry. How can we possibly expect the WHO to make impartial, disinterested recommendations about, say, the safety and efficacy of vaccines, when its own donors are financially invested in the success of specific pharmaceutical products, including vaccines?

Secondly, to allow the WHO to declare an international public health emergency is to create an obvious perverse incentive: given that a large part of the raison d’ĂȘtre of a WHO-led global health bureaucracy is to prevent, monitor, and respond to public health emergencies, and the activation of the WHO’s emergency powers depends on the presence of an actual or potential “public health emergency of international concern,” the WHO’s Director-General has an obvious professional and institutional interest in declaring potential or actual public health emergencies.

Third, the WHO wasted no time in praising China’s brutal and ultimately unsuccessful lockdownscontinues to support the censorship of their critics, repeatedly recommended community masking in the absence of plausible evidence of efficacy, failed to warn the public in a timely manner about the serious risks of mRNA vaccines, and has entered into a partnership with the European Union to extend the discriminatory and coercive Covid vaccine certificate system globally. These are certainly not people I would trust as custodians of my bodily integrity, health, informed consent, or mobility

https://www.zerohedge.com/geopolitical/these-amendments-would-open-door-dangerous-global-health-bureaucracy

Respiratory illnesses are surging in NYC and nationwide, CDC warns — states with highest rates

 Welcome to the Big Wheeze.

New York City is one of a handful of hotspots experiencing high rates of respiratory illness this month, the Centers for Disease Control reports.

The news comes on the heels of an earlier CDC report, warning of a recent 30% jump in hospitalizations for COVID-19 sufferers as well. Hospitalization rates are the highest among young children and senior citizens.

But COVID-19 is just one in a handful of illnesses making a nuisance of themselves in the Tri-State area, not to mention most Southern states and much of the Southwest, along with California.

All of these hotspots had either high or very high concentrations of COVID-19, Respiratory Syncytial Virus Infection (RSV), or influenza

The grisly trio has been referred to as “the tripledemic.”

Georgia and South Carolina are the two worst states in the country. Closer to home, upstate New York is experiencing low levels of the illnesses.

Respiratory illness rates are peaking across the US.
Respiratory illness rates are peaking across the US.CDC
“Everything that we’re hearing about it is not any new virus or new pathogen, it is the common things that we see every season that perhaps coming together,” Dr. Philip Huang, director of Dallas County Health and Human Services told ABC News.

“The preventive things are all the same, you know, stay home if you’re sick, wash your hands, cough into your sleeve, don’t rub your eyes, nose and mouth, get up to date on the vaccinations.”

The numbers for flu hospitalizations are also on the rise — there were a total 5,753 in the last week of November and the start of December. That number is up from 4,268 the week prior, per CDC data.

RSV cases have seen a minuscule decline, of late. Hospitals in Washington are reinstating indoor mask mandates as a way to manage the influx.

Doctors are advising caution as states across the US are seeing high numbers or respiratory illness cases.
Doctors are advising caution as states across the US are seeing high numbers or respiratory illness cases.Vladislav – stock.adobe.com

How to protect yourself during tripledemic season

In October, Dr. Kristin Englund of the Cleveland Clinic predicted the unwanted hodge podge of disease rearing its ugly head this winter, after experiencing its significant impacts last year.

She stresses that the best ways to protect yourself are quite standard: stay home when sick, wash your hands, and wash down areas that are often touched.

Dr. Englund also stresses the importance of staying up to date with vaccines, especially for Covid-19.

“Unfortunately, COVID continues to mutate, so the prior vaccines that we’ve had are no longer effective against COVID,” she said.

Currently, the CDC is tracking the variant JN.1, which stemmed from an Omicron subvariant.

It currently makes up about a fifth of cases.

https://nypost.com/2023/12/12/lifestyle/respiratory-illness-massively-surging-in-nyc-15-states-cdc/

Tuesday, December 12, 2023

What's going on with Moderna

 Moderna Inc MRNA announced changes to its operating model to bring focus to its short- and long-term business goals.

The company is focused on driving continued sales of its COVID-19 vaccine and launching its Respiratory syncytial virus (RSV) vaccine in 2024, while also preparing to launch multiple products per year from 2025 forward. 

The company has decided to increase executive focus on driving sales of Spikevax and the expected launch of its RSV vaccine next year. 

Last month, the European Patent Office said a contested mRNA patent owned by Moderna is invalid, marking a victory for Pfizer Inc PFE/BioNTech SE BNTX in a patent dispute between the biggest coronavirus vaccine makers

To do this, Stephane Bancel, Chief Executive Officer of Moderna, will assume responsibility for sales and marketing in 2024, working directly with the commercial team. 

To ensure the company maintains momentum on its launches beyond 2024, Stephen Hoge, President of Moderna, will assume responsibility for pipeline commercial strategy and Medical Affairs. 

https://www.benzinga.com/general/biotech/23/12/36199743/whats-going-on-with-moderna-stock-today

Portland Officials Propose To Re-Ban Public Drug Use, Governor To Declare "Fentanyl Emergency"

by Stephen Katte via The Epoch Times,

Portland's Central City Task Force (PCCTF) has proposed to restore a ban on illicit drug use in public areas as part of the city's long-term plan to solve its "most pressing challenges."

The PCCTF was launched in August to address issues like homelessness, public safety, drug use, and crime in Portland after the Oregon Health Authority warned in May that, on average, three residents are dying every day from an unintended drug overdose.

Task force co-chairs Oregon Gov. Tina Kotek and Dan McMillan, president and CEO of The Standard insurance company, recently released the task force's action plan of ten priority recommendations for 2024, including banning controlled substances and reducing barriers to prosecuting large drug trades.

The task force said that state lawmakers should restore law enforcement's ability to prosecute for attempting to deliver illicit drugs to another party based on the amount.

More police and increased "law enforcement responses around the Central City" are also suggested.

Portland passed measure 110, the Drug Addiction Treatment and Recovery Act, in November 2020 with 58 percent voter supportAfter becoming law, illicit drugs such as fentanyl, methamphetamine, and heroin were decriminalized, allowing small amounts to be carried for personal use.

The city has since been grappling with increased homelessness and substance abuse, both of which critics contend have been exacerbated by Measure 110 and the decriminalization of hard drugs. Portland City Council voted unanimously on Sept. 6 to ban substances such as fentanyl and heroin from being used in public amid the ongoing opioid and public health crisis.

Authorities in Oregon seized tens of thousands of fentanyl pills in Multnomah County back in August, marking the largest illegal drug bust in county history, according to officials. Upon closer inspection of the seized drugs, authorities found 58,000 individual fentanyl pills and 16 pounds of fentanyl powder. Fentanyl, a synthetic opioid, can prove deadly as it is many times more potent than heroin, elevating overdose risk.

Other proposals from the PCCTF to combat the spiraling drug issues facing the city include ramping up existing infrastructure for effective and speedy implementation of a drug public use ban, while also declaring a tri-government fentanyl emergency for Oregon, Multnomah County, and the City of Portland. As part of the proposal, these areas would declare a 90-day emergency on fentanyl and establish a command center led by the state to deal with the ongoing fentanyl crisis.

Gov. Kotek, a Democrat, announced on Dec. 11, after the action plan by the PCCTF was released, that she will declare a statewide fentanyl emergency and expects leaders in both Portland and Multnomah County to do the same, saying that "Times of crisis can lead to a desire for drastic change."

Between 2020 to 2021, the number of unintentional fentanyl deaths across the state more than doubled from 226 to 508, according to the Oregon Health Authority. Overdoses in the state continued to increase between November 2021 to November 2022, when deaths surpassed the national average by sevenfold, according to the Centers for Disease Control and Prevention.

Ms. Kotek said that confronting the challenges facing the city and the broader state will require "the hope and fortitude of an entire community."

"We have a set of concrete recommendations, some the first of their kind, others that tap into Portland's strengths in innovation, collaboration, art, and culture," she said.

"The reward for a strong start is more work. I am committed to this effort and excited to see this work unfold," the governor added.

Mr. McMillan also believes solving ongoing issues in the region will require a united effort, an idea that he says the task force has been discussing since day one.

"When the Governor and I convened the task force in late summer, it was under the theory that Portland's challenges don't solely rest on the shoulders of government, community, or business and that you need diverse, and sometimes unlikely, partnerships to get big things done," Mr. McMillan said.

Among the other recommendations by the PCCTF are increasing homeless shelter capacity and deploying more counseling and direct support services for unhoused people. Cosmetic changes are also on the agenda, such as removing plywood barriers and fences erected around federal buildings to protect them from vandalism during the waves of social justice protests that erupted after the in-custody death of George Floyd. Ms. Kotek and McMillan said the use of barriers "sends the wrong signal to visitors."

A moratorium on new taxes and targeted tax relief has been suggested as well. The PCCTF said that "Portland is the second highest taxed city in the nation; we trail New York City by only a fraction."

To reduce the tax pressure on residents, the task force is proposing that elected officials agree to a three-year pause, through 2026, on any new taxes and fees.

https://www.zerohedge.com/political/portland-officials-propose-re-ban-public-drug-use-governor-declare-fentanyl-emergency

Canadian Med Schools Asked To Shift From "Medical Expertise" To Anti-Racism & Social Justice Training

 by Jonathan Turley,

There is a major controversy brewing in Canada over a proposal in the Royal College of Physicians and Surgeons that schools shift from emphasizing “medical expertise” in favor of teaching “anti-racism” and social justice values.

An organization of physicians called Do No Harm is opposing the recommendation of the interim report by the college’s Anti-Racism Expert Working Group.

The report states that the new emphasis should center around “values such as anti-oppression, anti-racism, and social justice, rather than medical expertise.”

By “de-centering medical expertise,” the anti-racism experts suggest courses focusing on  “anti-racism,” “anti-oppression,” “social justice and equity,” “inclusive compassion,” and “decolonization.”

That includes the perils of capitalism and other “power structures”:

“Anti-racism is deeply rooted in anti-oppression, which analyzes the world through the lens of power, including the historical and ongoing structures of racism, white supremacy, settler colonialism, heteropatriarchy, capitalism, ableism, classism, sexism, homophobia, transphobia and more. Anti-racism and antioppression call for action on the manifestations of oppression based on race, ethnicity, religion, sex, gender identity, sexual orientation, socioeconomic status, immigration status and more. “

In a separate report, the group has also opposed U.S. medical schools filtering out applicants who opposed DEI values.

The group states that it found that “the admissions process at 50 of the top-ranked medical schools found that 36 asked applicants their views on, or experience in, DEI efforts” to “screen out dissenters.”

Most U.S. medical schools currently have some DEI and diversity courses incorporated into their curriculums. Some now give an alternative hippocratic oath pledging social justice and anti-racist action.

It is not clear how much of the traditional curriculum would be displaced under the recommendation in Canada.

With a kid in his first-year of medical school at Georgetown, I am amazed at the overwhelming burden on these students in taking these medical courses. The first year curriculum seems an all-consuming effort to cover the basic medical jargon, training, and science. I cannot imagine shoe-horning other subjects into that dense coverage or what would be jettisoned to make room for the new emphasis.

https://www.zerohedge.com/political/canadian-medical-schools-asked-shift-medical-expertise-anti-racism-social-justice

At Grocery Stores, Customer Marketing Data Is Becoming The Product

 For years we have been writing about how hedge funds have been buying any type of data they can get their hands on to try and anticipate moves in the American consumer and, by proxy, the market. 

And now the latest spot they could be buying their data from could wind up being your grocery store. Everybody knows that we are now accustomed to putting our phone numbers or email addresses into a computer almost literally every time we buy something - but few people know why they really do it and even fewer feel they have control over what retail establishments do with such data. 

Consumers feel powerless about the data-grab. A new study from the University of Pennsylvania showed that "79% of Americans feel they have little control over what marketers can find out about them", according to CNBC.

The same survey found that over half of adults in the United States, approximately 56%, are unclear about the meaning of "privacy policy." A common misconception among these individuals is that such policies assure that a company will not distribute their personal data to third parties unless consent is explicitly given.

Lead researcher Joseph Turow, Robert Lewis Shayon Professor of Media Systems & Industries at the Annenberg School for Communication said: “People don't feel that they have the ability to protect their data online — even if they want to.” 

Among other things, the Penn survey revealed:

  • Only around 1 in 3 Americans knows it is legal for an online store to charge people different prices depending on where they are located. 
  • More than 8 in 10 Americans believe, incorrectly, that the federal Health Insurance Portability and Accountability Act (HIPAA) stops apps from selling data collected about app users’ health to marketers.
  • Fewer than one in three Americans know that price-comparison travel sites such as Expedia or Orbitz are not obligated to display the lowest airline prices.
  • Fewer than half of Americans know that Facebook’s user privacy settings allow users to limit some of the information about them shared with advertisers.

R.J. Cross, director of Public Interest Research Group’s Don’t Sell My Data campaign, told CNBC: “Retailers today are doing just about everything they can to get as much information about you as possible, because that’s a whole new revenue stream for them.”

“Almost every single company that you’re shopping at today is in the business of selling your data, and you and your data are their latest product,” Cross continued. 

And the market for data on what you buy is growing exponentially. 

As of 2021, the data brokerage industry was estimated to be worth around $319 billion, with projections suggesting it could exceed $545 billion by 2028, CNBC wrote.

Traditionally, retailers relied on purchasing information from data brokers to understand consumer behavior. However, in a shift towards greater efficiency, these retailers are now bypassing intermediaries and are gathering consumer data firsthand through various methods, including loyalty schemes, location tracking, mobile app usage, and digital receipt analysis.

Refive founder and CEO Mitul Jain concluded: “My face is part of the data that’s being captured, my behavior, and all of that gives off many more pieces of information about me, my age, my gender, my ethnicity. And all of these pieces of information can then again be combined together with all these other little tidbits that I’ve been leaving behind from my shopping journey.“

https://www.zerohedge.com/markets/grocery-stores-customer-marketing-data-becoming-product

ASH: Sanofi’s Sarclisa carves out a multiple myeloma niche

 Sanofi’s anti-CD38 antibody Sarclisa has struggled to make headway against Genmab and Johnson & Johnson’s rival Darzalex since it was first approved for multiple myeloma, but new data from the IsKia trial could help breathe new life into the drug.

At the American Society of Haematology (ASH) congress, Sanofi reported that Sarclisa (isatuximab) added to the standard KRd regimen of Amgen’s Kyprolis (carfilzomib), lenalidomide, and dexamethasone improved minimal residual disease (MRD) negativity rates in bone marrow transplant-eligible patients with newly diagnosed multiple myeloma compared to KRd alone.

The 302-subject study showed that 77% of the Sarclisa group achieved MRD negativity at the end of the induction and consolidation phases of treatment, compared to 67% of the KRd group, which was a statistically significant difference.

The result comes shortly after Sarclisa was shown to add a benefit when added to another first-line multiple myeloma regimen for transplant-ineligible patients – VRd (Takeda’s Velcade (bortezomib) plus lenalidomide and dexamethasone) – in the IMROZ study, which is also due for presentation at ASH.

“Effective front-line treatment is critical for newly diagnosed patients, because achieving undetectable levels of disease early in the treatment journey may lead to better long-term outcomes,” commented Sanofi’s head of oncology development, Peter Adamson.

“The statistically significant rates of MRD negativity observed with Sarclisa combination therapy further support our belief in Sarclisa as a potential best-in-class therapy.”

Sarclisa has been FDA-approved since 2020 as a combination with Bristol-Myers Squibb’s Pomalyst (pomalidomide) and dexamethasone for adults with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

It had its label extended a year later to include second-line or later treatment of multiple myeloma as a regimen with Kyprolis and dexamethasone (Kd).

It’s still a long way behind Darzalex (daratumumab) in the market, however, with sales of the two drugs €278 million (around $300 million) and $7.2 billion, respectively, in the first nine months of this year.

J&J and Genmab’s drug has been approved as a first-line therapy since 2018, initially in transplant-ineligible patients and later in transplant-eligible patients, so, the IsKia and IMROZ trial results – if added to the label for Sarclisa – could help Sanofi build some momentum for the product as it tries to reduce its reliance on immunology blockbuster Dupixent (dupilumab).

Sarclisa is also being tested in the phase 3 GMMG-HD7 trial as a combination with VRd in previously untreated transplant-eligible myeloma patients, which could set up regulatory filings in 2025.

It is worth noting that, since 2020, Darzalex has also been cleared in a new subcutaneous formulation, Darzalex Faspro, that can be used in place of the original intravenous formulation, lending another advantage over J&J and Genmab’s drug.

Sarclisa is currently available as an IV formulation only, although, it is developing a subcutaneous version that is in late-stage development.

https://pharmaphorum.com/news/ash-sanofis-sarclisa-carves-out-multiple-myeloma-niche