HIGHEST NUMBER SINCE FEBRUARY 2020 - TSA
Saturday, June 25, 2022
Promising hep B data helps GSK inch closer to functional cure
An interim analysis of GSK’s experimental hepatitis B therapy bepirovirsen in a mid-stage study has raised hopes for a functional cure for millions suffering from a chronic infection, the British drugmaker said on Saturday.
If the results are reinforced in later-stage trials, the British drugmaker has estimated the drug could generate peak sales of more than 2 billion pounds ($2.5 billion) annually.
Although there are safe and effective vaccines for the hepatitis B virus - including shots made by GSK – nearly 300 million people globally have chronic hepatitis B (CHB), a long-lasting infection that occurs when the body is unable to fend off the virus and it persists in the blood and liver, according to the World Health Organization (WHO).
The mid-stage study is evaluating the impact of administering bepirovirsen in patients who were either on or off existing standard CHB therapy.
In the group of 227 patients on standard therapy, 24 weeks of treatment with bepirovirsen resulted in 28% of patients with sharp reductions in two key biomarkers of CHB such that a test would not be able to detect them.
Meanwhile, in the cohort of 230 patients who were not already on standard therapy, 24 weeks of treatment with bepirovirsen resulted in 29% of patients with corresponding decreases in the same biomarkers.
How durable these responses are remains to be seen.
Patients must be off therapy for typically six months or more and show no evidence of recurrence of the virus to achieve a functional cure, Christopher Corsico, GSK’s head of development, told Reuters.
But this data suggests that a functional cure is possible, Corsico said.
"The fact that you have such a high number of responses, just even when you stop the therapy is unprecedented ... compared to other drugs that are out there being tested."
Existing CHB medicines, such as nucleoside/nucleotide analogues (NA), are often taken for life because they suppress but rarely clear the virus. Despite their use, patients can develop serious complications, including liver cancer. In 2019, hepatitis B resulted in some 820,000 deaths, according to WHO estimates.
GSK, led by CEO Emma Walmsley, licensed bepirovirsen from Ionis Pharmaceuticals in 2019. The drug is designed to combat the disease on three fronts: by inhibiting viral replication, by suppressing the production of viral proteins associated with hepatitis B virus infection, and by stimulating the immune system.
What happened to the lab-leak hypothesis?
Covid cases are rising again. In the UK, they have broken through the 200,000 infections-a-day threshold for the first time since April. In America, the sixth wave is well under way. In countries that kept the disease at bay for years, such as Taiwan and New Zealand, numbers are shooting up, driven by milder but highly infectious versions of the Omicron variant. The virus has not gone away, even if its death toll is much lower. But what has disappeared is any real or urgent interest from the media and the scientific establishment in finding out how it started.
Imagine if the accidental launch of a nuclear missile had killed 21 million people. It’s hard to believe the world would shrug and say: let’s not bother finding out how it happened. The Covid pandemic has killed around that number and disrupted the lives of billions. Nothing like it has happened in more than a century; it is the greatest cause of global suffering since the Forties. Yet we still do not know how it started, and much of the world seems to be increasingly incurious to find out.
We co-authored a book, Viral: The Search for the Origin of Covid-19, on this topic in 2021 and it proved to be an odd experience. Eschewing speculation and sticking to what we could prove, we delved deep into the evidence and wove together the threads that linked bat viruses from southern China or Southeast Asia with an outbreak in Wuhan in late 2019. We concluded that it was impossible to be sure yet, but two theories were plausible: spillover from an animal to a person at a market, or an accident in a laboratory or during a research field trip.
In this we are in line with the US government, the G7, the World Health Organisation and the general public, all of whom are on record as saying that they think a leak from a Wuhan virology lab is a strong possibility that deserves to be investigated. The latest WHO report two weeks ago confirms this, saying that it is important “to evaluate the possibility of the introduction of SARS-CoV-2 into the human population through a laboratory incident”. That is huge news. It means that an accident caused by human error may have happened on the same scale as a nuclear missile destroying New York.
Our book received praise from readers: we received letters and emails from senior scientists, politicians, businessmen, journalists, and others commending it as a non-fiction whodunnit.
All that was gratifying. But it stood in marked contrast to the reaction in much of the media. CNN invited us on to discuss the book then cancelled at the last minute — at the behest of their health editor. The BBC simply ignored the book altogether, as did the other mainstream US and UK networks. The topic remains taboo in much of the mainstream media. Reviews were mostly bad — in both senses of the word. That is to say, they were highly critical and inaccurate. In some cases, the authors said things that made clear they had not read the book but had made up their minds to dislike it. Not one but two virologists told us on Twitter that the book was full of lies — and that they had not read it. An odd thing for anybody to admit to, especially a scientist.
The Smithsonian Institution in Washington invited us to give a presentation on the book, then cancelled the invitation. We asked the Royal Society if they had considered a debate on the topic of the origin of the Covid pandemic: no, they said, it’s not a proper topic for scientific discussion. What? We tried a couple of other learned societies: no, sorry, too controversial. Seriously.
Opinion polls show that the public generally thinks the virus began with a lab leak. So virologists who think it did not ought to be keen to have an opportunity to make their case, rather than avoid debate.
We think we know why people feel so threatened by Viral. After all we are not lab-leak extremists and we have also been attacked by those who are. But by taking down credible moderate voices, our critics within the scientific establishment are polarising the issue and casting the lab origin hypothesis as one that is only championed by anti-science or uninformed groups. As Professor Jonathan Haidt of New York University has pointed out, on social media these days it is common for activists to spend a lot of time criticising moderates on their own side of an argument.
The Chinese authorities have made it clear that any discussion of a possible lab leak is — in their view — xenophobic bullying. “The lab leak theory is totally a lie concocted by anti-China forces for political purposes, which has nothing to do with science,” said China’s Foreign Ministry spokesman on 10 June. (Although they also argue that a lab leak of Covid from US laboratories should be investigated.) This stance from the Chinese government puts universities and scientific journals in a tough spot because of their increasing dependency on Chinese funding and patronage.
Science funders are embarrassed to note that, as Jeffrey Sachs of Columbia University has recently documented, some of the funding that went into collecting and manipulating bat viruses in Wuhan came from the West, so better to let that sleeping dog lie. Virologists are worried that fingering a lab leak will affect their flow of grant money or result in more oversight and regulation of virology research. One scientist told us that: “If we investigate and expose an error on the part of scientists, then the public will no longer trust science.” As if choosing to deliberately not uncover a possible error would make people trust science more.
Science journalists generally see their job as cheerleading for scientists, not investigating them, so have largely refused to engage with the evidence for a lab leak. Some environmentalists would prefer the episode to be a cautionary tale about the destruction of rainforests. The issue has rapidly become partisan with Republicans largely driving the calls for an investigation. Bipartisan efforts and proposals to investigate the origin of Covid — a pandemic that has taken the lives of more than a million Americans — have proceeded at a glacial pace. Many younger commentators see blaming a Chinese lab as more racist than blaming Chinese eating habits for some reason (despite the fact that no bats or pangolins were found to be sold in Wuhan markets in the years leading up to the pandemic). And so on.
In short, there is a confluence of vested interest that results in a lot of motivated reasoning. It is hard to find anybody, with the exception of a few fringe media outfits, who is being paid as part of their day job to investigate the possibility of a lab leak without fear or favour. The people who have persisted in keeping the lab-leak hypothesis alive, against staunch opposition by some virologists and the media, are doing it in their spare time and at their own expense — as are we.
One of the commonest criticisms we have received from scientists is that by writing a book we are profiteering from a pandemic, an odd charge to come from people also earning salaries and grants to investigate the virus and its effects. Anyway, we took an early decision before the book was published, which we made public, to give away half of the proceeds from the book to charity.
Perhaps the oddest reaction we get from scientists, politicians and even journalists is this: why does it matter? The pandemic has happened, it cannot be undone and we may never know how it started, so why rake over the coals and stir up animosities? We find this astounding as an argument. If we don’t know how this pandemic started, how can we inform strategies to stop the next one? If we don’t investigate, what signal does that send to bioterrorists? If we shrug our shoulders, what respect does that show to the memory of the dead? The risk of lab-based outbreaks does not disappear if we pretend they are unlikely.
Another excuse we hear for the refusal to engage in the debate is that the Chinese government is secretive and authoritarian, so it will never share the vital information that we need to determine the origin of the virus. This seems to us defeatist, as is the often-expressed view that we cannot know how this pandemic started unless we get cooperation from the Chinese authorities. Like Dr Sachs, we think it is possible that a diligent investigation of the kind that has not yet been launched may yet solve the mystery even without Chinese cooperation. A steady trickle of revelations from within Western institutions has confirmed our view.
The World Health Organisation did in 2020 launch an inquiry into the source of the virus, which unfortunately gave Western governments the excuse to do nothing. It proved to be an embarrassing farce: months of dilatory negotiations over terms of reference, followed by the appointment of experts with conflicts of interest, then a brief chaperoned visit to a few spots in Wuhan, culminating in a press conference at which the WHO meekly endorsed an evidence-free Chinese theory that the virus had been imported to Wuhan on frozen food possibly from overseas. More than a year later, the WHO has now published a preliminary report from its scientific advisory group for the origins of novel pathogens (SAGO), which admits that the lab leak needs to be investigated — 30 months after the pandemic began.
That this pandemic flared up in a powerful and influential country with no free press, little freedom for scientists to speak out and centralised control of information by a totalitarian dictator certainly makes it uniquely difficult to investigate. Had it occurred in almost any other country in the world — the US, India, Brazil, even Russia — we think it would have been impossible to prevent the truth emerging.
But China’s refusal to be transparent has been matched by a determined effort on the part of many Western scientists to prevent a proper investigation getting under way. Despite thinking privately that a lab leak was most definitely possible — as shown by emails revealed through freedom of information requests — these scientists now appear even more keen than the Chinese authorities to tell the media that the matter is settled and they are sure the first infection happened in Wuhan’s seafood market.
Yet no infected animal on sale in the market or elsewhere in China has been found, and there is no evidence of exposure to SARS-like viruses among Wuhan market traders prior to the Covid outbreak. The amount of evidence for a wildlife trade origin of the virus is comparable to that for a research-related origin — both are plausible ways for a bat coronavirus from southern China or Southeast Asia to have made its way to Wuhan in central China, but both pathways remain poorly investigated. As we say to those who claim it definitely came via wild animals in the market, we don’t think you are certainly wrong, but we do think you are wrongly certain.
Matt Ridley is the co-author of Viral: the Search for the Origin of Covid 19 Alina Chan is a Scientific Advisor at the Broad Institute of MIT and Harvard and co-author of Viral: The Search for the Origin of Covid-19.
https://unherd.com/2022/06/what-happened-to-the-lab-leak-hypothesis/
To combat opioid crisis, try non-opioid substitutes
Last week, Reps. French Hill (R-Ark.) and Debbie Dingell (D-Mich.) wrote about legislation they’re championing to address the nation’s opioid epidemic. The Preventing Overdoses and Saving Lives Act 2.0 would require co-prescribing opioid overdose reversal drugs alongside prescriptions for opioid-based painkillers.
While I applaud the members’ attention to this dire and worsening public health crisis, and with all due respect to the members of Congress, we have tried this type of approach before. Many times. And it hasn’t worked.
In the last decade, Congress has dedicated hundreds of millions of taxpayer dollars toward combatting the opioid epidemic. Money that has gone to support first responders, increase access to treatment for substance use disorder, and ensure widespread availability of naloxone. Yet here we are — with record-breaking numbers of Americans dying every year from an opioid-related drug overdose.
Last year, the CDC reported that approximately 107,000 Americans died of a drug overdose. Three-quarters of these deaths involved opioids. All told, we lost 220 Americans every day from an opioid-related drug overdose in 2021. This represents a 90 percent increase since 2018. Clearly, this problem is getting worse before it’s getting better.
It’s time to try something different.
For many, the path to addiction starts innocently enough — including after undergoing a routine surgical procedure. Ninety percent of surgery patients are prescribed opioids to manage their pain and, of these, four million will initiate long-term opioid use following such procedures.
Focusing on access to overdose reversal drugs — while important — perpetuates opioids as the standard of care for treating postoperative pain. Such an approach misses the opportunity to prevent substance use. One way to accomplish this would be to minimize unnecessary exposure to opioids for surgical patients. This is particularly important for younger, opioid-naïve patients.
We must do more to prevent opioid use disorder, including increasing access to safe, effective, and non-addictive pain management options. Unfortunately, current Medicare reimbursement policies continue to incentivize the use of opioids to treat postsurgical pain. This approach puts a non-opioid pain management option out of reach for tens of millions of surgery patients every year.
Pending federal legislation would address this issue. The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act (HR 3259 / S 586) would update Medicare reimbursement policy to incentivize the use of FDA-approved non-opioid pain management options. The legislation would increase access to and use of FDA-approved non-opioid pain management options. In the process, the legislation would prevent individuals from developing an opioid use disorder and, ultimately, save lives.
This legislation would deliver patients, providers, and caregivers options for treating postsurgical pain. And, with fewer patients being exposed to prescription opioids, fewer Americans will initiate a long-term opioid use habit. If we can prevent individuals from misusing opioids, we can save lives. It’s that simple.
The NOPAIN Act is gaining momentum on Capitol Hill. The legislation is supported by more than 150 members of Congress, including nearly half of the Senate. I urge Congress to take a different approach to the opioid epidemic ravaging our communities. Let’s try preventing opioid addiction before it starts and pass this critical legislation. American lives hang in the balance.
Chris Fox is executive director for Voices for Non-Opioid Choices.
States should protect caregivers’ Medicaid funds from union skims
Robert and Patricia Haynes live in Mich. and provide full-time care for their adult children, Kevin and Melissa, who suffer from severe cases of cerebral palsy. Until 2014, they were forced to give a portion of their Medicaid reimbursements to the Service Employees International Union (SEIU), a scheme propagated by unions such as SEIU and the American Federation of State, County and Municipal Employees (AFSCME) that is commonly known as to as “dues skimming.”
Yet, while a number of states including Michigan have taken action to prohibit the dues skim, a May rule by the federal Department of Health and Human Services (HHS) reversed a Trump administration effort to stop the skim nationally. A separate 9th Circuit decision last week also continues to allow unions to trap home care providers into paying them.
The Hayneses, like other caregivers across the country, are eligible for Medicaid reimbursement from the state for the care they provide to their disabled children. However, over a decade ago, unions worked with state policymakers in about a dozen states to permit the siphoning of union dues from Medicaid money the Hayneses received. Without their permission or intent, the state reclassified the Hayneses as “public employees” at the behest of SEIU — and they had to pay their dues.
Many members of the “home care workforce” are relatives or friends providing care to sick family members or loved ones in need.
It took years to end the dues skim in Michigan, including administrative action by former Gov. Rick Snyder, legislative reform, lawsuits and the defeat of a ballot measure backed by the unions in a last-ditch effort to keep the dues skim alive. After the SEIU took $34 million from providers like the Hayneses, this unfair policy finally ended.
But caregivers in states such as Illinois, Oregon and Washington had to wait until 2014 before unions could stop forcing them to pay fees to take care of their loved ones. In a landmark case, Harris v. Quinn, the U.S. Supreme Court said unions could not force Pamela Harris — an Illinois mom caring for her son Joshua, who needed constant care for developmental disabilities — to pay union fees.
But that same year, HHS under President Obama adopted a federal rule to explicitly allow Medicaid funds to be diverted to unions. While providers did not need to pay, unions could still trap them into paying. By 2017, the Freedom Foundation estimated that unions were skimming an estimated $150 million each year, affecting 358,000 caregivers’ Medicaid funds.
The reason was that, after Harris v. Quinn, at least 11 states allowed dues skimming and unions were able to make providers pay dues by establishing arbitrary opt-out windows that limited when caregivers could leave and stop paying union fees. Cindy Ochoa, who was taking care of her disabled son, Adam, even experienced the union’s forgery of dues authorization signatures to keep the payments flowing.
Then, in 2019, the Trump administration reversed the rule, prohibiting unions from taking Medicaid payments from providers. Now, President Biden’s commitment to being the “most pro-union president ever” is coming to fruition: the new rule from HHS once again gives federal blessing to dues skimming.
A debate exists over whether states or the federal government have the authority to issue policies pertaining to these Medicaid reimbursements. While Medicaid dollars are funded in part by the federal government, state governments allocate the money. Some states, such as Michigan, have banned dues skimming, but Biden’s decision means that caregivers in many states without such statutory protections may be forced to pay union fees.
The nature of home care means that unions don’t represent these caregivers in the traditional workplace or in negotiations with an “employer.” A parent is not going to file a complaint against his or her sick child. Neither is a union going to negotiate benefits when the supposed “employer” is a sick or disabled relative.
Yet, the Biden administration’s HHS rule and the 9th Circuit decision are prioritizing the dues skim over the best interests and financial needs of caregivers and our nation’s most vulnerable patients.
As Michigan has done, states must act now and not wait for the federal government or the courts to rule justly. State policymakers owe it to caregivers like Robert and Patricia Haynes, Pamela Harris, and Cindy Ochoa to pass laws prohibiting the dues skim from Medicaid payments, ensuring that these caregivers have maximum support and flexibility to provide for those they love.
Lindsay B. Killen is vice president for strategy and communications at the Mackinac Center for Public Policy, a research and educational institute in Midland, Mich.
Friday, June 24, 2022
Horizon: Candidate Effective in Neuromyelitis Optica Spectrum Disorder Phase 3
Horizon Therapeutics plc (Nasdaq: HZNP) today announced new findings from a post hoc analysis of the N-MOmentum Phase 3 pivotal trial of UPLIZNA supporting the medicine’s efficacy in Europeans living with NMOSD. These data are being presented during the 8th Congress of the European Academy of Neurology (EAN), June 25-28 in Vienna.
UPLIZNA received marketing authorization from the European Commission (EC) on April 25, 2022 and is the first and only targeted CD19+ B-cell-depleting monotherapy proven to reduce attacks in adult patients with NMOSD who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+). This post hoc analysis compared attack rates, disability-related outcomes and safety among 50 trial participants from the European Union (EU) (including participants from Bulgaria, Czech Republic, Estonia, Germany, Hungary and Poland) versus 163 non-EU participants.
PwC Projects 'Flurry of Deals' Across Life Science Industry
A new report by PwC projects that the second half of this year will see a “flurry of deals activity across all areas of the sector.”
The report, titled “Pharmaceutical & Life Sciences: Deals 2022 Midyear Outlook,” indicates that the U.S. Federal Trade Commission (FTC) has increased scrutiny of larger deals, which would suggest there will be more bolt-on acquisitions in the range of $5 to $15 billion. Even by the standards of the first half of this year, all but Pfizer's purchase of Biohaven Pharmaceutical for $11.6 billion are smaller than that.
The first half has been fairly quiet, but now, the report indicates, the large pharmaceutical companies have a lot of cash, especially if they have COVID-19 treatments in their portfolios. Also, a lot of companies are facing patent cliffs in 2025, so they may be willing to acquire some products to fill in the expected gaps created by generic and biosimilar competition.
Mergers and acquisitions (M&A) have been down 58% compared to the first half of 2021, with a valuation of $61.7 billion. In terms of deal volume, there have been 137 deals, down 33% from the same period last year. The biggest deals so far have been the Pfizer-Biohaven acquisition, Bristol Myers Squibb’s takeover of Turning Point Therapeutics for $4.1 billion, GlaxoSmithKline’s buyout of Affinivax for $3.3 billion and Biocon Biologics’ acquisition of Viatris’ biosimilars portfolio and related commercial and operational capabilities for $3.3 billion.
The report includes several sectors, including pharma, biotech, medical device and “other/services.” In pharma, deal activity is down about 30% on a semi-annualized basis, with deal values dropping about 50%. This only reinforces the industry’s interest in smaller deals built around a single asset or a bolt-on deal. They believe this is related to increased FTC scrutiny.
At the same time, the industry “continues to experience labor shortages, supply chain snags and higher input costs - particularly around packaging - due to inflationary pressures. To stay nimble in a rapidly changing environment, pharma companies are re-examining capital allocation strategies, as well as considering alternative options for their supply chains.”
Their analysis of the biotech subsector, without a clear definition of the differences between pharma and biotech, focuses on the XBI biotechnology index, which peaked in January 2021, outpacing the S&P 500. However, it’s been declining ever since with more than 60 biotech companies announcing layoffs so far this year, with some shuttering their doors completely. The initial public offerings (IPOs) have also been dramatically slower this year. In 2021 104 biotech IPOs brought in almost $15 billion, but 2022 has only reported 14 IPOs so far that have raised less than $2 billion collectively.
The pharma patent cliffs will exert pressure, with PwC predicting almost $180 billion in revenue from the largest companies will be at risk between 2023 and 2028. At the top of that list is likely AbbVie’s Humira, which brought in $20.694 billion last year all on its own, but begins losing patent exclusivity in 2023.
The report suggests that “pharma is in a good position to combat this issue as most companies have plenty of cash on hand and can take more risks by purchasing early-stage assets. With capital becoming harder to come by for most biotechs, pharma is in a good position to acquire many of these companies at a discount from their highs of just a couple of years ago.”
That may be so, but it can take a long time for a new drug to replace the income from a blockbuster, although prices for cutting-edge gene and cell therapies are so high that might be a focus of investment.
Other factors the entire industry is facing are drug pricing, antitrust scrutiny, inflation, and the Russian invasion of Ukraine. The majority of companies are trying to overcome the disruptions from two-plus years of the COVID-19 pandemic — although to be fair, some companies such as Pfizer, BioNTech and Moderna have greatly benefited from the pandemic — but are now struggling with inflation and supply chain issues. It’s possible the mid-term elections in November will generate some stability over drug pricing and other regulatory issues, although that seems optimistic. Inflation, energy supplies and supply chain issues will likely persist and possibly increase as the Russia-Ukraine conflict continues.
The report states, “Expect pharma and life science executives to revisit operational strategies as they navigate these uncertainties.”
https://www.biospace.com/article/pwc-report-expects-flurry-of-deals-across-life-science-industry/
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