Sammy in Winter Comforts

Flu relief is coming as successors to aging Tamiflu near market

Originally published February 11, 2018 at 5:00 pm

Researchers around the world are pushing ahead with a raft of new options for treating and preventing a disease that kills as many as 650,000 people worldwide in its seasonal form and could wipe out millions of lives in a severe pandemic.

By Jason Gale Bloomberg News

Flu has been on a vicious march this winter, evading vaccines, overwhelming hospitals and prompting school closures from California to Hong Kong in its wake. But relief in the form of new drugs is on the way.

Almost two decades after Roche Holding’s Tamiflu first reached pharmacy shelves, researchers around the world are pushing ahead with a raft of new options. None will arrive in time to help sufferers this winter, but the most advanced — developed by Roche and Shionogi & Co. — could be on the market in Japan within months and available in the U.S. and Europe next winter.

The new medicines will give doctors more options for treating and preventing a disease that kills as many as 650,000 people worldwide in its seasonal form and could wipe out millions of lives in a severe pandemic. The global influenza therapeutics market will swell to $1.2 billion by 2025, from $600 million in 2016, Acute Market Reports predicted in December.

“For several decades now, we have not sought to develop the tools we need to fight the flu,” said Olga Jonas, a senior fellow at the Harvard Global Health Institute in Boston and former World Bank economist. “The tax we pay for this folly is as inexorable as it is enormous.”
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Jonas estimates the global costs of flu exceed $100 billion a year, considering that some 20 percent of the population can be infected seasonally.

Tamiflu, which generated more than $3 billion in sales when swine flu sparked a global contagion in 2009, reduces the duration of illness by only up to a day if it’s taken within the first 48 hours of the onset of symptoms. What’s more, some seasonal strains have developed mutations that decrease its potency, spurring calls for alternatives.

“It’s very important to have more options, as you can tell from this flu season,” said Daniel O’Day, head of Roche’s pharma unit, in an interview in Basel, Switzerland, on Feb. 1.

Tamiflu, also known by its chemical name oseltamivir, works by blocking a protein on the surface of flu viruses called neuraminidase that enables newly made germs to escape from an infected cell and spread. GlaxoSmithKline’s Relenza, BioCryst Pharmaceuticals’ Rapivab and Daiichi Sankyo’s Inavir operate in a similar way.

“We really do need another effective antiviral with an alternative biological mechanism,” said Benjamin Cowling, professor and head of epidemiology and biostatistics at the University of Hong Kong.

Baloxavir, the flu drug discovered by Osaka, Japan-based Shionogi, recently received preliminary approval in Japan. Co-developer Roche aims to file for regulatory review in the U.S. and Europe later this year, according to O’Day.

The medicine works by inhibiting an enzyme that the virus needs to replicate inside a host cell and requires a single dose, unlike Tamiflu, which is usually taken twice a day for five days.

“The advantage is that it’s one pill once, versus a course of therapy, so particularly for pandemic planning, this could be an advantage,” O’Day said. “You don’t have the potential resistance that comes with not completing your course of therapy.”
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Johnson & Johnson’s Janssen unit could be next to market with a therapy called pimodivir, which should enter a late-stage study early this year. The experimental medicine received fast-track designation from the U.S. Food and Drug Administration in March due to its potential to address an unmet medical need. Discovered by Vertex Pharmaceuticals, the drug targets part of a gene present in the majority of seasonal flu viruses, blocking them from making copies of their genetic material.

Another potential therapy in the most advanced stage of testing is nitazoxanide, which wasn’t developed for influenza. The drug is the only licensed treatment for a type of waterborne parasitic infection. In flu viruses, it prevents mature virus particles from leaving host cells.

J&J is also pressing ahead with the development of a universal flu vaccine. A shot that works against multiple strains of the virus is a holy grail for the medical field because it could eliminate the need to formulate a new vaccine every year.

There’s another approach that is years away because it hasn’t been tested in humans, but which Lorena Brown, a professor of microbiology and immunology at the University of Melbourne, says may have the potential to transform the field.

Melbourne scientist Wen-Yang Wu, who helped discover Relenza, is developing a novel way of preventing flu viruses from infecting respiratory cells. It works by reshaping the hemagglutinin, another protein on the surface of the virus, by creating a low pH environment that mimics the change that occurs after a virus invades a host cell, he said.

In the presence of the drug, the virus prematurely and irreversibly changes the conformation of hemagglutinin, rendering it unable to bind and enter the cell, according to Wu. In animal studies, a single dose has been shown to provide monthlong protection against flu, and a single dose 72 hours after infection has been shown to successfully treat the disease.

“This is a totally new and very clever concept of how we think about making antivirals,” said Brown, whose lab undertook some of the testing. “If it works as well in humans as our animal studies show, it will dramatically enhance our options.”

Aus Bio, which is developing the medicine, may be able to begin trials in humans in 12 to 18 months depending on the outcome of talks with potential partners, said Peter Jenkins, an executive director.

Besides so-called small-molecule drugs, at least five different antibody-based therapies are being evaluated in clinical trials to treat severe flu cases, according to Aeron Hurt, a senior research scientist with the World Health Organization’s Collaborating Center for Reference and Research on Influenza in Melbourne. Most rely on features of the human immune system to neutralize proteins on the surface of flu viruses.
With assistance from Naomi Kresge and Lisa Dur

The “Steele Dossier” on … Me:

Why I won’t praise the FBI lie & spy machine
By Greg Palast

Do we hate Trump so much, we’ll cheer FBI perjury, cheer the monstrous FISA star chamber and the surveillance horror show exposed by Ed Snowden?

Like it or not, that creepy little GOP shill Rep. Devin Nunes, revealed facts that should scare us. First, FBI agents failed to tell the Foreign Intelligence Surveillance (FISA) court that the file it used to justify spying on a US citizen, the “Steele dossier,” was paid for by Hillary Clinton’s campaign.

True, the FBI dropped a footnote about the source coming from a “political entity,” a fuzzy cover-our-ass comment that failed to state known partisan bias. But failure to tell the court the whole truth and nothing but the truth is perjury.

Ironically, Nunes himself commits the same perjury, by failing to mention the original creator of the report. Before Hillary paid for a copy, the file was already written for a news front sponsored by Republican billionaire Paul Singer. Singer: Better known as “The Vulture.”

Singer The Vulture, the court should have been told, has a long history of creating what FBI Director James Comey himself called “salacious and unverifiable” files on his enemies.

I know. Because The Vulture created a file on me. And on elected officials worldwide who got in the way of his next billion. Poisonous garbage – but really effective, deadly garbage.

In 2011, I flew to the Congo and discovered that The Vulture had seized the funds meant to end a cholera epidemic. I reported on Singer’s deadly capers at the top of the BBC news, on the front page of the Guardian and on Democracy Now!

To spike the story, The Vulture’s PR flunky called BBC and said, “We have a file on Greg Palast.” Apparently, it contained the same kind of salacious garbage peddled by Steele.

The BBC pressed Singer’s flak to turn over the actual dossier. Singer’s flunky backed down after admitting it contained old fabricated smears that had been long discredited. (In fact, a US power company had to write me a fat check in punishment for the libel.)

So, it’s personal. When I hear that some Trump toady is slimed by a suspect Singer file, I don’t clap with joy.

Steele-style dossiers by GOP Vulture

Singer has slipped secret, poisoned dossiers to media outlets to destroy the reputations of elected officials from Argentina to the Congo — all to make another billion.

Indeed, his PR flak boasted how he had planted stories about the president of the Republic of Congo with a pliant Washington Post. It was part of Singer’s campaign to seize $400 million from the Congo for old bonds he bought for just $10 million during the nation’s civil war. Singer seized funds that were made available to the Congo by US and European taxpayers to help the destitute nation clean its water supply and end a cholera epidemic.

Even the US Treasury has accused him of “extortion.”

Singer’s smear campaign shifted to Argentina. The nation’s President Cristina Kirchner refused to pay “El Buitre” (The Vulture) billions he demanded for old bonds based on legal flim-flam. Vulture-financed groups deployed dossiers that accused Kirchner of murder!

It worked. The new president, Mauricio Macri, in his first days in office, paid Singer the billions of dollars Kirchner had refused.

FBI texts: truly dangerous

Not all dangerous thumbs belong to Trump.

While Nunes’ memo is poisoned by comically pro-Trump bias, we cannot ignore his exposure of the ill influence of partisan FBI agents like Peter Strzok.

I ask you to read the texts to his love-interest, Justice Department attorney Lisa Page. I don’t give a toot about their fooling around, I care about how they deliberately bent the investigation of Hillary Clinton to protect her.

Bernie Sanders supporters take note. Strzok admitted that the FBI somehow overlooked that Clinton’s email server, which she claimed was used for wedding invites and the like, contained several emails marked with a ‘c’ for “confidential.”

Worse, Strzok, wrote that he saw himself as providing an “insurance” policy against Trump’s election. Remember that Comey press conference in which he stated that Clinton was “extremely careless” in handling classified emails? The Democrats blamed that for Hillary’s loss. In fact, it would have been far worse, except that Strzok convinced Comey to change the language to “extremely careless” from the much harsher – and possibly criminal – “grossly negligent.”

You can hate Trump all you want. But when FBI agents bend official statements to protect one candidate over another, our democracy is shot in the stomach.

Is Trump a bloviating bigot, a nuclearized narcissist miscreant? That’s a fact. So, why are we rushing to join his bonfire of our liberties?

Take my word for it: you don’t want the FBI picking our presidents.

The choice between FISA and freedom

Finally, I cannot believe my fellow progressives are now cheerleaders for the FISA court, the very agency Edward Snowden courageously exposed as the judicial inquisitors blessing an ugly police spy state.

Just one of the thousands of FISA court spy authorizations — revealed by Snowden — permitted the National Security Agency to get every single phone call made by Verizon callers, and similar demands were approved to seize the records of every major phone carrier.

The ACLU has been in legal combat with the FISA court over “mass, warrantless surveillance of Americans,” allowing use of “Network Investigative Techniques” (i.e. malware), and information collected under the law without a warrant that could be “used to disproportionately target disfavored groups, whether minority communities, political activists, or even journalists.”

I ask a simple question: have we no shame?

Again, the Nunes Memo does not discredit Mueller nor his investigation.

Nevertheless, the Nunes Memo exposed FBI perjury, how in secret the FBI brought the full dark powers of the surveillance state down on US citizens based on fabricated slanders, and used official power to flak for a Presidential candidate. And progressives are applauding?

So I ask you what Snowden asks: When you’ve crossed the wrong billionaire, when they come for you, will they quote your own words in praise of the Gestapo Lite?

A version of this story was first printed in Truthout

Greg Palast (Rolling Stone, Guardian, BBC) is the author of The New York Times bestsellers, The Best Democracy Money Can Buy and Billionaires & Ballot Bandits, now out as major motion non-fiction movie: The Best Democracy Money Can Buy: The Case of the Stolen Election (the brand new, updated, post-election edition).

The update of Greg Palast’s film, The Best Democracy Money Can Buy: The Case of the Stolen Election is now available on Amazon and Amazon Prime.


What the fuck is wrong with us?


Flu kills up to 4,000 Americans a week, causing 1 in 10 deaths – SFGate

(Bloomberg) — The amount of influenza ravaging the U.S. this year rivals levels normally seen when an altogether new virus emerges, decimating a vulnerable population that hasn’t had a chance to develop any defenses.

It’s an unexpected phenomenon that public health experts are still trying to decode.

The levels of influenza-like illnesses being reported now are as high as the peak of the swine flu epidemic in 2009, and exceed the last severe seasonal flu outbreak in 2003 when a new strain started circulating, said Anne Schuchat, the U.S. Centers for Disease Control and Prevention’s acting director. Swine flu, which swept the globe in 2009 and 2010, sickened 60.8 million Americans, hospitalized 274,304 and killed 12,469, according to CDC data. Deaths from the current outbreak will likely far outstrip those of the 2009-2010 season.

“This is a difficult season, and we can’t predict how much longer the severe season will last,” she said. “I wish there was better news, but everything we are looking at is bad news.”

The primary type of influenza this year hasn’t changed enough from previous seasons to be considered a novel strain, Schuchat said. The agency’s virologists are studying it to determine if there are any other explanations for why it’s been so hard-hitting.

“We have a lot to learn still about influenza,” she said. “It’s a wake-up call about how severe influenza can be, and why we can never let down our guard.”

Deaths from influenza and pneumonia, which are closely tied to  each other in the winter months, were responsible for 1 of every 10 deaths last week, and that’s likely to rise, Schuchat said in a conference call Friday. There were 40,414 deaths in the U.S. during the third week of 2018, the most recent data available, and 4,064 were from pneumonia or influenza, according to the CDC data. The number for that week is expected to rise more reports are sent to the agency.

It gets worse. The death toll in future weeks is expected to grow even higher because flu activity is still rising—and the number of deaths follow the flu activity. Hospitalization rates are already approaching total numbers seen at the end of the flu season, which may not be for months.

“Unfortunately, more deaths are likely to happen,” Schuchat said. “Over the next few weeks, we do expect and it would make sense to see more pneumonia and influenza-related deaths. The people who are likely to die are already in the hospital.”

This year’s flu could be more calamitous than outbreaks going back decades, but there’s no way to know for sure. It’s difficult to compare the severity of influenza across seasons for more than a handful of years because of changes in how the virus is handled in the U.S. The CDC started recommending universal vaccination to stop the spread of the virus in 2010, after previously targeting only those in high-risk groups who were most likely to die from an infection.

The agency reported another 10 deaths among children this season, bringing the total to 63 so far. Half had no other medical conditions that would place them in the high-risk category, and only about 20 percent were vaccinated.

The agency only started counting deaths among children in 2004, after a particularly severe season. That year, the number of doctor’s office visits for the flu peaked at 7.6 percent; last week it was 7.7 percent.