Industry awaits names of 10 drugs subject to federal price negotiation

 On or before September 1, the Centers for Medicare and Medicaid Services will release the names of the 10 Part D drugs subject to negotiated prices in Medicare starting in 2026.

This the first time the federal government is negotiating drug prices with pharmaceutical manufacturers, a move PhRMA and other opponents say should be more accurately called mandatory price controls. 

The move is being allowed under the Inflation Reduction Act, which was signed into law on August 16, 2022.

The list is expected to drop any day, but no later than September 1, according to John Stanford, executive director of Incubate, a coalition of early-stage life science investors. 

"We thought it might be on the anniversary of the IRA," Stanford said.

Which 10 of the top 50 in revenue Part D drugs will be on the list is not known, though pharma companies in court filings said they expect four of their blockbuster medications to be targeted, according to CNBC.

These include, according to the report: Type 2 diabetes drug Januvia; blood thinners Eliquis and Xarelto; and blood cancer drug Imbruvica. The report mentioned other drugs named by the Journal of Managed Care and Specialty Pharmacy: Jardiance, used to treat heart failure; Enbrel, for rheumatoid arthritis; Symbicort, for asthma; Ibrance, for breast cancer treatment; Xtandi, for prostate cancer; and Breo Ellipta, to manage pulmonary disease.

WHY THIS MATTERS

Whatever drugs are on the list, the IRA and subsequent action by the Department of Health and Human Services are already limiting investment in drugs that are manufactured in pill form, according to Stanford.

Incubate is in the camp of being against the CMS drug negotiation process, at least as it stands.

"Our voice is in venture capital," Stanford said. Price controls, he said, are an "anathema to investment."

While not part of the lawsuit filed by PhRMA and others in June, Incubate is lobbying Congress to get more favorable conditions for the pharmaceutical industry. But most lawmakers are taking a wait-and-see approach, Stanford said.

Companies make their investments 10 years in advance, he said.

"There's damning consequences, not in 10 years, but now," Stanford said. 

The reason is HHS has set a timeline for when new drugs become subject to negotiation.

There's two types of drugs, large molecules, more commonly called biologics, such as Humira which are given by infusion, and small molecules, which are manufactured in pill form. 

Biologics are subject to a maximum fair price in year 13. 

"But really devastating is the cut to small molecules, which is down to nine years," Stanford said. 

Generally a patent term is for 20 years. The cut to nine years, he said, "is hugely upsetting."

"We're seeing a shift away from small molecules," Stanford said. "We're working on legislation to give both 13 years. We have to make it a popular bipartisan fix."

The small molecule exception is for the development of drugs for diseases that affect those younger than Medicare age, as that cost would be paid by the commercial market.

"It's now inserting Washington and incentives by Washington in the drug development cycle," Stanford said. "For all of us, this is a flawed way to think about the healthcare system."

Most people have access to pills, he said, but in rural America, it's harder to get to the nearest hospital to be infused with a biologic.

"If you're a hospital, you'd better be making room for people to come in the doors," Stanford said. 

THE LARGER TREND

In March, CMS released guidance for the Part D price negotiation program and in June released revised guidance.

PhRMA, the National Infusion Center Association and the Global Colon Cancer Association filed a lawsuit against HHS in the Western District of Texas on June 21, calling the Drug Price Negotiation Program unconstitutional.

"The cost of developing such groundbreaking drugs is stunning," the lawsuit said. "On average, a manufacturer will spend nearly $3 billion developing one new medicine."

Since the IRA became law, HHS has introduced several initiatives to lower drug prices, such as capping the cost of insulin at $35 a month. 

In June, the Centers for Medicare and Medicaid Services released a list of 43 prescription drugs for which Medicare Part B beneficiaries' coinsurances may be lower due to the stipulation that manufacturers pay a rebate to Medicare if a drug's price increase exceeds the rate of inflation.

https://www.healthcarefinancenews.com/news/industry-awaits-names-10-drugs-subject-federal-price-negotiation

Bioxytran Announces FDA Clearance of its IND Application for ProLectin-M in Clinical Trials

 First Antiviral Drug in Glycovirology

https://www.marketscreener.com/quote/stock/BIOXYTRAN-INC-117540343/news/Bioxytran-Announces-FDA-Clearance-of-its-IND-Application-for-ProLectin-M-in-Clinical-Trials-44690138/

Will You Comply?

 by Jeffrey Tucker via The Epoch Times,

There are new mask mandates in Southern California and talk of them coming back in various spots around the country, including a university in Atlanta. Contact tracing too is back, even though that never works for respiratory viruses. Rumors are swirling about new lockdowns for some new variant that is being touted by the World Health Organization (WHO). The predictable CNN is interviewing Pfizer employees about the glories of their new booster just rubber-stamped by the FDA.

And Fauci is out and about defending lockdowns and suggesting that we could have more.

The first time is tragedy, said Karl Marx, and the second time is farce.

We might be headed into the realm of farce, as masks that everyone knows don’t work are mandated and shots that everyone knows don’t work to stop the spread are widely encouraged. Mandates for them could easily be next. In fact, not one government policy from the entire pandemic period achieved anything but destruction.

Now we see the problem with the failure to have a real reckoning over the COVID response. It means that the whole panoply of failed and brutal policies could come back again.

As NPR reminds us on a daily basis, we now “have the tools” necessary to combat another pandemic or even the spread of seasonal viruses—and never mind that none of these tools actually work and all of them demoralize the population.

At the same time, the hashtag #donotcomply is trending. Many people swear that they will not go along this time. Maybe that’s right but I’m not prepared to predict mass refusal. There were many times during the last lockdowns and masking that I refused to comply but that can create awkward situations.

The store owner and I agreed that masks are dumb and we both went without. The next time I went in, he told me to put one on. I asked why. He said that passersby were looking through the windows and noticing we were not wearing masks and reported the store to the local government. The health inspectors arrived demanding answers.

That was enough to convince him. He was not going to risk the well-being of his shop in what he considered to be a trivial issue of mask compliance. He would not die on this hill.

I totally get it. I respect very much people who swear that they will not go along but I also understand those who comply. It’s a tragedy but not everyone wants to be a martyr for the cause of freedom. To be sure, if no one went along, all the lockdown regulations would effectively be null and void. There aren’t enough enforcers to bring about compliance if the whole population doesn’t go along.

But that’s not usually how it works. Typically in these cases, the government can always count on a portion of the population to do the work of coercion for them. That’s why it is called totalitarianism: the whole of society involves itself in its own self-destruction. We saw it under China’s Cultural Revolution where the Red Guard did most of the killing, and we saw it in the COVID lockdowns when average people felt moved to rat out their fellow citizens to the health police.

All of this takes me back to the writings of Étienne de la Boétie and his important essay “The Politics of Obedience.”

The author is a French aristocrat and the year of writing was 1552.

It’s as powerful then as it is now.

“I should like merely to understand,” he wrote, “how it happens that so many men, so many villages, so many cities, so many nations, sometimes suffer under a single tyrant who has no other power than the power they give him; who is able to harm them only to the extent to which they have the willingness to bear with him; who could do them absolutely no injury unless they preferred to put up with him rather than contradict him. Surely a striking situation! Yet it is so common that one must grieve the more and wonder the less at the spectacle of a million men serving in wretchedness, their necks under the yoke, not constrained by a greater multitude than they.”

Perhaps it is cowardice? Boétie answers:

“If a hundred, if a thousand endure the caprice of a single man, should we not rather say that they lack not the courage but the desire to rise against him, and that such an attitude indicates indifference rather than cowardice? When not a hundred, not a thousand men, but a hundred provinces, a thousand cities, a million men, refuse to assail a single man from whom the kindest treatment received is the infliction of serfdom and slavery, what shall we call that? Is it cowardice? ... When a thousand, a million men, a thousand cities, fail to protect themselves against the domination of one man, this cannot be called cowardly, for cowardice does not sink to such a depth. ... What monstrous vice, then, is this which does not even deserve to be called cowardice, a vice for which no term can be found vile enough.”

Instead, he counsels mass non-compliance or civil disobedience. He says that even the most powerful government is rendered powerless by the mass refusal of the public to go along. If that happens, government simply ceases to have authority and power. All the guns and weaponry are rendered useless. The state lives off the people’s willingness to be bullied. If they stop being willing, the state simply falls.

“Resolve to serve no more, and you are at once freed. I do not ask that you place hands upon the tyrant to topple him over, but simply that you support him no longer; then you will behold him, like a great Colossus whose pedestal has been pulled away, fall of his own weight and break in pieces.”

That’s a powerful and brilliant vision, one that has inspired me for a very long time. In addition, the 20th century saw some powerful implementations, particularly those led by Mahatma Gandhi and Martin Luther King, Jr.

But how plausible is it that something like this can happen in our time? Government does everything in its power to make sure that it does not happen. The most important tool is propaganda. That can take many forms. It could be preachers yelling about eternal damnation of the refuseniks but it could also be fancy Pfizer executives calmly explaining how a new potion will protect the population against a pathogen. In both cases, the government is able to tap into the mortal fears of the public.

And to make sure that only one message gets out, censorship becomes an imperative.

This is why the CDC and NIH, along with the DHS and the CIA, involved themselves so heavily in social media and search engines to make sure that the public did not hear any voices of dissent. This way people will be discouraged from resisting.

Also important is restricting gatherings.

This was the real point of “social distancing” restrictions, not to protect you against viruses but rather to stop people from meeting others who were similarly incredulous. The goal was to isolate people so that they become demoralized and feel like crazy people.

A major problem for all of the non-compliers this time is that we are still very much in the minority. This is partly owing to the propaganda. Google and YouTube, which make up 90 percent of both search and video traffic, are heavily censored by government. YouTube has even stated that it will not allow any content that contradicts the World Health Organization, which is the entity that started all this lockdown stuff to begin with.

I commend everyone who swears they will not go along. But every circumstance is different.

It is not always so easy to refuse. Everyone has jobs and income needs. People also seek social approval and thus cave when it matters most. Like Étienne de la Boétie,

I long for a time of mass non-compliance. We are closer to that point now that we were three and a half years ago but I seriously doubt we are there just yet.

https://www.zerohedge.com/medical/will-you-comply

Mexican Cartels Increasingly Use Drone-Dropped And Roadside Bombs

 Behaving more and more like a military force, Mexican drug cartels have greatly increased their use of improvised explosive devices in their combat with authorities and rival criminal gangs, the Mexican army said on Tuesday.  

Already this year, 42 police officers, soldiers and others have been wounded, nearly triple the count in 2022. Fatalities have included a National Guard officer and several police officers. 

"All of these explosive devices are homemade, based on tutorials that can be found on the internet,” said Defense Secretary Luis Cresencio Sandoval. Most of the them use either readily-purchased black powder, or explosives stolen from Mexican mines. They're deployed in a variety of ways -- including roadside bombs, car bombs, and bombs dropped from drone aircraft. 

Drone-bombings are surging: The tactic wasn't seen before 2020, but 260 such attacks have been tallied this year. "Even that number may be an underestimate: residents in some parts of the western state of Michoacan say that attacks by bomb-dropping drones are a near-daily occurrence," reports Associated Press. 

Most of the bombings have occurred in three states: Clockwise from northwest, they are Jalisco, Guanajuato and Michoacán 

The bombs often fail to explode, but when they do, the results can be catastrophic. July brought one of the most spectacular set of bombings yet -- as a coordinated series of seven road bombs killed four police and two civilians in what the governor of Jalisco called "a trap" targeting law enforcement. Four vehicles were destroyed and 14 people were injured by bombs so strong that they cratered the highway. 

A majority of the explosive deployments have been recorded in Michoacán state, where the Jalisco cartel has long been at war with a federation of local gangs. 

Bombings almost seem charming in contrast to a godawful cartel video that circulated from Mexico this week. It depicted the decapitation slaughter of five kidnapping victims. Traveling to attend a festival in Jalisco, they were apparently lured with a bogus employment opportunity, with the intent of forcing them to work for the cartel. Authorities believe they refused. Most horrifically, the video seemed to depict one of the victims being forced to bludgeon and decapitate another, before being killed himself. 

For Mexicans, the video resurrected memories of a 2010 incident in which abducted men who refused to serve the cartel were forced to fight each other until death with sledgehammers. Let's pray these horrors stay south of the border.  

https://www.zerohedge.com/geopolitical/mexican-cartels-increasingly-use-drone-dropped-and-roadside-bombs

Hedge Funds Dump Record Amounts Of Chinese Stocks In Longest Selling Stretch On Record

 Not too long ago, investors - especially "smart", fast money - loved plunking money in China, especially during painful drawdowns.

Not this time: according to Bloomberg, global investors have sold China’s blue-chip stocks during the longest stretch of outflows on record, signaling that even the nation’s "blue chip" leaders are falling out of favor as the neverending rout deepens.

According to the latest flow data on individual stocks available on Bloomberg, foreign investors sold 6.2 billion yuan ($851 million) of liquor giant Kweichow Moutai during Aug. 7-18, making China’s largest liquor maker the most heavily sold stock via trading links with Hong Kong. It was followed by 4.7 billion yuan of selling each for leading renewables stock LONGi Green Energy Technology Co. and major lender China Merchants Bank.

The 10 most-sold stock by foreigners in the latest rout were among the 50 largest ones on the CSI 300. Major distiller Wuliangye Yibin, Ping An Insurance Group of China, and EV maker BYD saw selling of at least 2.9 billion yuan each through Aug. 18.

In total, overseas funds offloaded the equivalent of $10.7 billion in Chinese shares in a thirteen-day run of withdrawals through Wednesday - the longest since Bloomberg began tracking the data in 2016 - as they fled the mainland market. The departures comes as a prolonged housing slump raises the risk of broader financial contagion, making the nation’s equity benchmark among the worst global performers this month with a nearly 8% loss.

Goldman's Prime Brokerage group made a similar observation, finding that hedge funds net sold Chinese stocks for 3 straight sessions and in 12 of the 16 days MTD. In cumulative notional terms as seen on the Prime book, this month's net selling in Chinese equities - onshore and offshore combined - is approaching record levels vs. monthly net flows of the past decade.

Importantly, long liquidations accounted for more than 70% of the notional net selling MTD. This month's notional long selling already exceeds the levels seen in Aug '21 and Jul '15 and is on track to be the largest over the past decade.

Including the August MTD activity, hedge funds have now reversed all of the cumulative notional net buying in Chinese stocks from Nov '22 to Jan '23 (aka "the reopening trade"). Since the start of February, ~56% of the cumulative notional net selling has ben driven by A-shares with the remainder roughly split between H-shares and ADRs.

Chinese equities collectively now make up ~7.6% of global net market value on the Prime book, vs. 9.5% at the start of August and 11.2% at the start of 2023, the lowest level since early November and in the 14th percentile vs. the past five years.  Aggregate long/short ratio in Chinese equities now stands at ~2.2 (vs. ~2.7 at the start of 2023), also at the lowest level since November and in the 14th percentile vs. the past five years.

The CSI 300 Index is now trading at its lowest since November as optimism of another stimulus following the July Politburo meeting quickly evaporated, even as China's social mood is turning uglier by the day amid record youth unemployment which is rising by one percent every two months. Foreigners had moved into the market en masse back then, only to leave again now in droves as economic data continue to disappoint and stimulus fails to impress.

A separate Bloomberg analysis showed that emerging market funds have also turned more bearish on Chinese stocks, deepening their average underweight position to almost 100 basis points as of the second quarter from 24 basis points three months earlier. They were overweight by 40 basis points as of end-2022.

The selling streak is showing little sign of cooling, and on Wednesday overseas funds shed another 10.5 billion yuan. A top-performing Chinese macro hedge fund blamed global capital for sinking the country’s stocks, calling them a “bunch of aimless flies” that stir up market volatility. The silver lining is that foreign funds own less than 4% of total A-shares outstanding, according to a report this month from China International Capital Corp. Of course, by the time they are gone, the financial assets of the Chinese population will be worth a fraction of what it is now.

https://www.zerohedge.com/markets/hedge-funds-dump-record-amounts-chinese-stocks-longest-selling-stretch-record

Doctor Suspended Over Covid Vaccine Stance To Sue Ohio Medical Board

  by Zachary Stieber via The Epoch Times (emphasis ours),

A doctor whose license was recently suspended by Ohio's medical board is planning to sue the board.

Dr. Sherri Tenpenny is planning to fight the decision, which members of the State Medical Board of Ohio said was over the doctor's response to their investigation into her critical comments on COVID-19 vaccines, Dr. Tenpenny's lawyer says.

"We're going to definitely be filing suit," Tom Renz, the lawyer, told The Epoch Times. "I don't think there's really any question about that."

The suit will focus on alleged violations of Dr. Tenpenny's due process rights and will challenge the suspension. Depending on the components, it may be filed in state court or may be filed in federal court.

"We're going to just make sure that we do what we wish they would have done, which is to be ethical, to follow the law, and to make sure that justice is served," Mr. Renz said.

The board declined to comment.

Suspension

Board members voted on Aug. 9 to suspend Dr. Tenpenny's license until she meets certain conditions, including paying a fine and cooperating with investigators.

Members and the office of Ohio Attorney General Dave Yost said that Dr. Tenpenny did not properly respond to questions prompted by complaints filed over her public testimony before the Ohio House of Representatives that included references to claims that vaccinated people had become magnetic.

"This case is not about Dr. Tenpenny making comments about how when you're vaccinated, 5g Towers could interfere with [you]. It's not about Dr. Tenpenny saying, when you are vaccinated, your body becomes magnetized. It's not about any of that, right?" Dr. Amol Soin, a board member, said ahead of the vote. "It really is about this whole issue of cooperation or not."

Dr. Tenpenny's actions included failing to appear at a deposition, according to Kimberly Lee, the state official who served as hearing examiner for the case.

"This is not punitive. This is procedural," Assistant Attorney General James Wakley said before the vote. "This is a stick necessary to ensure that we get the answers that we require based on the board's responsibility for ensuring the safety of the public."

Dr. Tenpenny and Mr. Renz say the state is mislabeling how she responded to questions and other investigative steps. They say she filed legal objections to the subpoena and other documents, that the investigation was unconstitutional in part because the state could not define how it defines "failure to cooperate" and because it would not show them the complaints.

"You may not like her position on vaccines, on COVID, on whatever it is that she has. But that's not the question before the board," Mr. Renz told the board. "The question before the board today is one simple question: 'Were her rights to due process violated? The record shows that they were. We have a hearing examiner who can't actually define what those rights are."

He added: "This appears very much like a witch hunt, like someone who's looking for an outcome rather than looking to follow the law."

The board declined to provide the complaints to The Epoch Times, citing state law. The law says that the board must investigate in a way that "protects the confidentiality of patients and persons who file complaints with the board."

The same law says that punitive action can be leveled in the event of failure to cooperate with a board investigation.

Mr. Renz also says that the state should have gone to court to resolve the matter.

Mr. Wakley said that going to the courts would lead to "a complete breakdown of the process of investigations" and that "justice delayed is justice denied."

If the board went to court for every case, "the board would never get anything done," added Dr. Jonathan Feibel, another board member.

Breathalyzer Comparison

Mr. Yost, a Republican, said that Dr. Tenpenny could have gone to the courts before the vote.

Mr. Renz said that it was the state's responsibility to compel and that they were not trying to cause a fight with the board.

Mr. Yost also told Just the News that Dr. Tenpenny's actions were like a driver who was pulled over refusing to take a breathalyzer.

Mr. Renz said that comparison did not make sense.

"If a cop pulls you over, and says, 'you need to take a breathalyzer,' he's got to have a reason for that, right? He's not allowed to just randomly pull you over and say you need to take a breathalyzer because he doesn't like how you look, he can't pull you over and say that you need to take a breathalyzer unless you're showing some signs and symptoms or give him some reason to think that you may be intoxicated," Mr. Renz said. "Otherwise, that's violating your due process rights."

https://www.zerohedge.com/political/doctor-suspended-over-covid-vaccine-stance-sue-ohio-medical-board

Watch: Trump Warns Tucker, "There's A Level Of Passion... And Hatred I've Never Seen"

 Tucker Carlson dropped a tease clip earlier in the evening of what to expect in tonight's interview, taking a jab at his former employer - who will be hosting the GOP debate directly against the discussion with Trump:

“Whatever you think of Trump he is the far and away indisputable front runner in the Republican race,” Carlson said during the less than minute long video.

“So when Trump approached us about having a conversation for a far larger audience than he would receive on cable news we happily accepted.”

Tucker asks some stunning questions, including: “Do you think Epstein killed himself?” and “Whatever happened to Mike Pence?”

Then Tucker goes there:

“It started with protests against you, then impeachment twice, and now indictments... Are you worried that they are going to try to kill you? Why wouldn't they try to kill you?"

Trump calmly responds:

I've seen the lengths that they go to... when they make up the Russia, Russia, Russia collusion and that's exposed... these are sick people. I think they hate our country."

On Biden:

"Crooked Joe Biden is so bad, he's the worst president in the history of our country. I don't think he's going to make it to the gate, but you never know."

"I think he's worse mentally than he is physically... and he's not exactly a triathlete."

"Do you think the rest of the world looks at Biden and thinks, somebody else must be running the government?"

"well, somebody elese has to be. I don't think he's capable of doing anything."

Fear of violence?

“Do you think we’re moving toward Civil War? Do you think its possible that there's open conflict?” Carlson follows up.

Trump nods, and responds:

"there's a level of passion that I have never seen. And there's a level of hatred that I've never seen... and that's probably a bad combination."

A rigged election?

"We got way more votes in 20 than in 2016... but the election was rigged...they used COVID to cheat in a lot of different things... and we have so much on it... but we had judges that didn't want to look... but I have never seen spirit like there is right now."

And finally, Tucker asks:

"you're saying they stole it from you last time, why wouldn't they do the same this time?"

To which Trump replies:

"well, they will try... they're going to try..."

Trump blasts the GOP establishment, saying that "Mitch McConnell was trying to get senators to impeach me."

Watch the full interview below (due to begin at 2055ET):

As we detailed earlier, former President Donald Trump is skipping tonight's GOP debates, and will instead appear for an interview with Tucker Carlson - where the pair will undoubtedly upstage the current crop of GOP candidates, who according to current polls, have no chance in hell of receiving the Republican nomination.

Trump confirmed in a social media post that his interview with former Fox News host Tucker Carlson will be released tonight (Aug. 23), just before the network's Republican presidential primary debate.

The former president announced on Truth Social that his previously recorded interview with Mr. Carlson will broadcast at 9 p.m.

“Sparks will fly,” President Trump wrote in his post about the interview, which will reportedly stream on X, the platform formerly known as Twitter.

"Many people are asking whether or not I will be doing the DEBATES?" Trump wrote on Truth Social last week.

"ALL AMERICANS have been clamoring for a President of extremely High Intelligence. As everyone is aware, my Poll numbers, over a ‘wonderful’ field of Republican candidates, are extraordinary. In fact, I am leading the runner up, whoever that may now be, by more than 50 Points. Reagan didn’t do it, and neither did others. People know my Record, one of the BEST EVER, so why would I Debate? I’M YOUR MAN. MAKE AMERICA GREAT AGAIN!"

Of note, the former president now holds the largest lead over his rivals according to a CBS News poll released on Saturday, while his nearest rival - Florida Governor Ron DeSantis - has fallen even further behind.

When it comes to Trump's multiple indictments, it's clear the right sees them as nothing more than a partisan attempt to dislodge him from the 2024 race. And with each new charge, Trump's status as a martyr (and ratings) continue to rise.

First, as was the case with Trump's previous indictments, Republican primary voters' overwhelming concern about the Georgia charges is that they're politically motivated.

They dismiss the premise of the charges: the bulk of them do think Trump tried to stay in office, but to them, it was legal and constitutional because these Republican primary voters overwhelmingly think President Biden didn't win legitimately. -CBS News

When asked whether the GOP candidates should argue the case for themselves, 91% agreed, vs. 9% who said they should talk trash against Trump.

What's more, around 75% of Trump voters are those who "show support for his legal troubles" as their rationale, while 99% say that "things were better under Trump."

Trump voters also generally believe Trump is telling the truth (duh), which is why the indictments aren't having an impact in support among his base. Voters who say they place top importance on a candidate being "honest and trustworthy" picked Trump at 61%, followed by DeSantis at 17%.

The context here is that Republican primary voters believe the political system is corrupt at an even higher rate than Americans overall do. That could mean perceiving Trump as railing against — or prosecuted by — that system might well make him seem, from their perspective, like the one telling a larger truth. 

And when it comes to who voters think has the best chance of beating President Biden, it's once again Trump in a landslide.

 

Is there a path forward for the other candidates?

Perhaps if they get used to being called "Mr. Vice President," if Trump should pick them. 

https://www.zerohedge.com/political/tucker-and-trump-team-upstage-foxs-gop-debates