Pfizer’s Bourla on Drug Pricing: 'We Have a Problem Here'

 Albert Bourla, chief executive officer of Pfizer, argued at the Yahoo Finance’s All Markets Summit this week that politicians were approaching the problem of drug pricing the wrong way — as usual.

The Biden Administration in August released a plan to decrease prescription drug costs covered by the Medicare program. One of the components of the plan was to allow Medicare to be able to negotiate to secure the best prices, which is currently prohibited by law. The plan also calls for drug companies that raise prices “faster than inflation” to pay a penalty and to cap the amount Medicare beneficiaries pay out-of-pocket for prescription drugs each year.

At the time, President Biden said, “Right now, we pay the highest prescription drug cost prices of any developed nation in the world — the highest. My Build Back Better Plan is going to lower prescription drug costs by finally giving Medicare the power to negotiate the prices of drugs they purchase for the American people, saving Americans hundreds of billions of dollars.”

Those initiatives were dropped from the plan after key Democrats objected to it.

“The issue of drug pricing is a real issue in the U.S.,” Bourla said. “But it is not the issue that some people think and present.”

A report issued by the RAND Corporation in January 2021 noted that U.S. prescription drug prices are higher than in other countries, with U.S. prices averaging 2.56 times more than what is reported in 32 other countries.

Bourla noted, “We have a problem here. The Americans are paying for their medicines like they don’t have insurance, although they do have insurance. And this needs to change. This needs to make sure that this will not be the case moving forward. I’m sure if they have to pay less, that will be a cost and the system will have to absorb the cost. Who is paying for that cost?”

Bourla’s rationale is that prescription drug prices are only a small portion of overall U.S. health care spending. Medicines represent 12% of costs to the system. “This is how much the employer, this is how much Medicare pays to us in terms of how much it pays to hospitals, physicians, everybody else. So by definition, this cannot be the big problem when we are 12%.”

He also pointed out that drug prices have been going down. Pfizer cited a 5% drop in net pricing of drugs in the U.S., a consistent trend.

“I’m sure the patients taking our medicines didn’t experience this -5%,” Bourla said. “They experience 2, 3, 5, 10, 20% sometimes increases in how much they have to pay … for the cost of the medicine. The two are not connected.”

But according to the Government Accountability Office (GAO), prescription drug spending has increased. The 12% figure is up from 7% in the 1990s. And a report by the IQVIA Institute for Human Data Science cited U.S. patients paying $67 billion out of pocket for prescriptions at retail pharmacies in 2019. That raises a question as to whether people are under-insured, uninsured, or insurance companies are not paying for drugs.

“Where we disagree,” Bourla said, “is policies that will take all the money from the pharmaceutical industry and move them to the black hole of the federal budget to do other things. This is not the issue right now. The issue is the out-of-pocket costs of patients, which are very, very high. That’s what we need to address.”

https://www.biospace.com/article/pfizer-s-bourla-on-drug-pricing-in-us-we-have-a-problem-here-/

TPD Summit 2021 – degrader validation for Nurix

 That an entire meeting now exists on protein degradation should awaken investors to what an important area of research this is. The young biotech Nurix yesterday became a beneficiary, reporting very early findings validating its lead clinical asset, NX-2127, a degrader of BTK. Of course, BTK inhibition is a hugely competitive approach in leukaemia, but Nurix argues that selective degradation of this kinase, rather than its mere inhibition, comprises a novel approach, avoiding downstream mutations and yielding effects lasting years. So far the oestrogen receptor has provided the biggest stage for degradation, courtesy of the Serds, and just last week Radius’s elacestrant scored in a phase 3 breast cancer trial, while today Sanofi revealed another delay to its rival, amcenestrant. Nurix told yesterday’s Targeted Protein Degradation Summit that NX-2127 had now been given to six patients, and caused 80-90% BTK degradation. All the patients had failed at least one BTK inhibitor, and partial response has been seen in a subject with the troublesome C481R mutation. Despite these being mere early hints Nurix climbed 17% to hit a market cap of $1.5bn, possibly driven by hope that degradation could take BTK into the hitherto untrodden ground of lymphoma.

Source: Targeted Protein Degradation Summit.

https://www.evaluate.com/vantage/articles/news/snippets/tpd-summit-2021-degrader-validation-nurix

26 FDNY firehouses out of service over vaccine mandate staff shortage

 The FDNY shuttered 26 fire companies citywide on Saturday due to staff shortages caused by the COVID-19 vaccination mandate, according to furious elected officials, who ripped the move as “unconscionable” — and could have catastrophic consequences.

The shutdown came amid a pitched battle between City Hall, which on Monday will start enforcing a mandate that all city workers have at least one dose of the COVID-19 vaccine, and jab-resisting firefighters, many reportedly saying they were already sick with the coronavirus and therefore have “natural immunity.”

Nicole Malliotakis (R-SI, Brooklyn) said 26 companies shuttered — five in her district — and laid the blame on  Mayor de Blasio.

“If someone dies due to a slower emergency response, it’s on Bill de Blasio and his overreaching mandates. I hope this fool fixes it ASAP!” she tweeted. Some residents rallied outside of the Ladder Company 149 in Dyker Heights to support the firefighters.

Fire Commissioner Daniel A. Nigro said the department “has not closed any firehouses.

“Irresponsible bogus sick leave by some of our members is creating a danger for New Yorkers and their fellow Firefighters,” Nigro said. “They need to return to work or risk the consequences of their actions.”

No borough or neighborhood was spared, with the shuttered companies ranging from Engine Co. 55 in lower Manhattan, to Engine Co. 234 in Crown Heights, to Engine Co. 231 in Brownsville. Others included Ladder Co. 128 in Long Island City and Engine Co. 158 and Ladder Co. 78 on Staten Island, according to information provided by Malliotakis and Councilman Joe Borelli (R-SI), who cited the Uniformed Firefighters Association. Borelli said the list of 26 came from a FDNY alert dispatched to members.

The FDNY has shut down 26 firehouses across the city due to staff shortages caused by the city’s COVID-19 vaccine mandate.

Daniel William McKnight

FDNY spokesman Jim Long said the closings are not permanent, describing the companies as “temporarily out of service” and the situation as “fluid” since it was shifting firefighters to units where they were needed.

As of late Saturday afternoon, the FDNY could not provide an exact number of closings that the pols said were in effect as of 7:30 am Saturday.

“The situation remains fluid. We hire manpower to get the company back in service or relocate other units to the area for coverage,” Long said.

In anticipation of a shortage of firefighters, NYPD’s Emergency Service Unit has requested the help of volunteer firefighters from Long Island and upstate to back fill the lost positions, according to an email obtained by The Post.

That was little solace to retired electrician Vinny Agro, 63, who lives across the street from now-offline Engine Co. 284 in Dyker Heights, Brooklyn.

The FDNY’s vaccination rate was at 72 percent at the deadline for the vaccine mandate on Friday.

REUTERS/Lloyd Mitchell

“We’re f- -ked. We are going to toast like marshmallows,” he said. “It’s another sad day for New York City.”

A man who lives next door to the firehouse said that he had not seen firefighters for about 24 hours and that they were desperately needed in the neighborhood.

“Most of the houses here are semi-attached frame houses. You throw a match on it, and it goes up real quick,” he said. “You need a quick response . . . it’s scary.”

Fire officials said last week that they were prepared to close as much as 20 percent of the companies citywide.

Saturday’s temporary closures represented 7.6 percent of the city’s 341 engine and ladder companies. But it was still an “unconscionable” number, said Borelli, who chairs the council’s committee on fire and emergency management.

“The firefighters who are unable to work have all been tested within the week and are not COVID positive, and I doubt New Yorkers care about the vaccine status of the person applying defibrillators to their chest,” he said.

Donald Watson, 57, a Downtown Brooklyn resident, said the firefighters were just “looking out for themselves.”

“It’s sad we have to go through this because of COVID,” Watson said. “A lot of them don’t want to take the shot. C’mon. It’s nothing but a shot.”

The FDNY’s vaccination rate stood at 72 percent for firefighters — and 77 percent agencywide — at the end of Friday, the city’s deadline for workers to get at least one dose of the vaccine, according to data from City Hall. Nearly 4,000 FDNY employees remained unvaccinated.

The mandate is expected to be enforced beginning Monday, and 26,600 city workers across all city agencies were still unvaccinated as of Friday night, according to City Hall. Those who don’t have at least one jab will be suspended without pay.

The NYPD stood at 84 percent of personnel vaccinated, and the Sanitation Department was at 77 percent.

The 77th Precinct in Crown Heights, Brooklyn, was slow to respond to calls Friday night as four officers on the 4 p.m.-to-midnight shift called in sick, sources said. Call logs showed response times of more than two hours in some cases.

The FDNY has blamed the shortage on people calling out sick to protest the mandate.

NHLI via Getty Images

“We have contingency plans in place if necessary, and there will not be any shortages in any commands. There will be no reduction in police services,” an NYPD spokeswoman said.

The FDNY has blamed the staffing shortage on firefighters calling out sick, with one insider saying “hundreds” of firefighters have been taking medical leave to protest the mandate.

“It’s definitely a sick-out. It’s a job action,” the insider said. “If they call in sick they have to go to the medical office. The medical office is overwhelmed.”

More than two dozen FDNY members were seen leaving the department’s medical office at the MetroTech center in Downtown Brooklyn Saturday.

A memo sent to members of the Uniformed Fire Officers Association on Friday said it was “still in negotiations” with the Office of Labor Relations “for an extension to the deadline as well as alternate methods of implementation.”

The memo, seen by The Post, advised all members, vaccinated or not, to report for duty when scheduled and make notations in the fire company’s journal about why they were asked to leave.

De Blasio has held firm, saying on Thursday that the city would not extend the jab deadline.

Vaccinations surged statewide this week, with 103,348 doses administered from Friday to Saturday, Gov. Hochul said on Saturday. On Monday, 45,217 doses had been given out in the previous 24 hours.

https://nypost.com/2021/10/30/fdny-firehouses-shuttered-over-vaccine-staffing-shortages/

Injecting Trouble

 Plans to open “safe injection sites” in New York City, long stalled, appear to be moving forward, though not at the speed that advocates would prefer. These sites, which Mayor Bill de Blasio prefers to call “overdose prevention centers,” will provide a place for drug addicts to inject themselves with narcotics, under medical supervision. When opioid users overdose, for example, medical personnel will be standing by to revive them.

Assuming de Blasio announces an inaugural date for the program before he leaves office at the end of 2021, New York will be the first municipality in the United States to sponsor “safe injection” as a city service, though Rhode Island is making similar plans at the state level. Philadelphia licensed an injection-site program, but it was blocked after the Trump administration opposed it in court. It remains unclear where the Biden Justice Department stands on the issue, but advocates appear hopeful that it will permit the program to launch.

Proponents say that safe injection sites are an obvious solution to the horrific problem of drug overdoses, which now kill more than 90,000 Americans annually. In 2020, the 30 percent leap in drug-overdose fatalities nearly matched the 40 percent increase in the nation’s homicide rate. Opioids killed 69,000 people that year, most of whom died after either injecting or insufflating synthetic opioids, whose hyper-concentrated nature makes it nearly impossible to titrate.

Establishing safe spaces for addicts to inject themselves, says city councilman Stephen Levin, “saves lives.” He explains that “these centers keep people from dying. The medical data is very clear. Any public health expert says it is not a controversial issue at all. Of course you want supervised injection facilities.” De Blasio echoes this premise. Taking issue with a reporter’s nomenclature, the mayor explained, “I call it overdose prevention centers, because I think it gets to the heart of what this is. It’s to save lives, stop people from overdosing, who could be saved and of course, to in every way, help them towards treatment and support. So, this is an idea that has worked in Canada. It’s worked in Europe. It’s an idea whose time has come.”

Advocates of safe injection sites, whether in government, the media, or in the nonprofit sector, all point to the Canadian experience as positive proof that such programs are a life saver. Insite, which opened in Vancouver, British Columbia, in 2003 as North America’s “first sanctioned supervised drug injection site,” is considered the gold standard of care from the perspective of “harm reduction.”

The principle of harm reduction is that society should ensure that all dangerous, dysfunctional behavior—drug abuse, unsafe sexual practices, failure to comply with psychiatric medical orders, living on the street—happens in as safe a manner as possible. People will not stop using drugs just because they are told not to, so the best way to manage the various side effects of drug abuse—overdose, festering wounds, poverty, crime, child neglect, despair—is to make using drugs as easy as possible. And in addition to preventing death or disease, harm-reduction programs create an opportunity for government social-service providers to conduct outreach, helping addicts or other people in need of services get in touch with care in a trusting, non-stigmatized environment.

It’s not hard, though, to see that harm reduction can be a long, dark tunnel to the light of the prosocial day. At Vancouver’s Insite, “when somebody’s struggling with their injection, like we can see they’re getting frustrated, agitated, poking or stabbing away at themselves, it’s our responsibility to see if we can help make that safer for them, to find a safer vein,” says Tim Gauthier, a nurse and the clinic’s coordinator. The staff at Insite don’t actively inject anyone, but it’s hard philosophically to explain why not, if it would be safer to do so. Similarly, if it is dangerous for an addict to have to go buy impure drugs on the street, how is it not morally justifiable for a harm-reduction center to offer to sell pure drugs on site, at cost? Or to give them out for free?

Advocates would surely object that these thought experiments don’t relate to the real-world work of saving lives. So how are Vancouver and Toronto doing in regard to overdoses? Not so well, it turns out. The British Columbia coroner reports at least 1,200 overdose deaths in the first half of 2021, “the highest ever recorded in the first seven months of a calendar year and . . . a 28% increase over the number of deaths recorded between January and July 2020 (941).” Toronto is doing no better: the Ontario coroner reported a record 521 opioid overdose deaths in the city in 2020, and the situation this year is much worse: one day in early May saw five deaths, the highest ever recorded. Even if, for the sake of argument, one wanted to concede the possibility that these numbers might be even higher in the absence of safe-injection sites, the difference made is on the margins. As Christopher Rufo wrote last year in a City Journal story on Vancouver’s program: “It’s not that addicts who use the safe-injection site are achieving sobriety; they’re just not dying on the floor of the Insite injection room.”

And none of this raises the other problems associated with “safe injection sites,” which are necessarily located in the areas where the scourge is the most acute, and which essentially make the blight permanent by encouraging drug dealers to prey on the sites’ users. Robbery of dealers and users will follow, as will street crime and associated dysfunctionality.

The presumptive next mayor of New York, Eric Adams, has said that he is in favor of the program. If he permits its introduction, he will be living up to the promise that de Blasio has said he sees in him.

Seth Barron is managing editor of The American Mind.

https://www.city-journal.org/nyc-safe-injection-sites-a-dangerous-plan

CDC clarifies unvaccinated young foreign travelers do not need to quarantine

 The Centers for Disease Control and Prevention (CDC) said on Saturday that unvaccinated foreign nationals under the age of 18 traveling to the United States by air do not have to self-quarantine upon arrival.

CDC Director Rochelle Walensky on Saturday signed a revised order c https://www.cdc.gov/quarantine/cruise/pdf/Vax-Order-10-30-21-p.pdflarifying that foreign national children who have not been vaccinated against COVID-19 do not need to isolate for seven days upon arrival in the United States. A CDC order issued on Monday had raised alarm among some foreign travelers that their children would need to quarantine for that long after arriving.

On Nov. 8, the United States is lifting the extraordinary travel restrictions that have barred most non-U.S. citizens who within the last 14 days have been in the United Kingdom, the 26 Schengen countries in Europe without border controls, Ireland, China, India, South Africa, Iran and Brazil. It is also imposing new rules requiring nearly all foreign adult air visitors to be vaccinated against COVID-19.

https://www.marketscreener.com/news/latest/CDC-clarifies-unvaccinated-young-foreign-travelers-do-not-need-to-quarantine--36848674/

China's Xi calls for COVID-19 vaccine mutual recognition

 Chinese President Xi Jinping on Saturday called for mutual recognition of COVID-19 vaccines based on the World Health Organization's emergency use list, according to a transcript of his remarks published by the official Xinhua news agency.

Speaking to the Group of 20 Leaders' Summit in Rome via video link, Xi said China had provided more than 1.6 billion COVID shots to the world, and was working with 16 nations to cooperate on manufacturing doses.

"China is willing to work with all parties to improve the accessibility and affordability of COVID-19 vaccines in developing countries," Xi said.

Xi reiterated China's support of the World Trade Organization (WTO) making an early decision on waiving intellectual property rights for COVID-19 vaccines, and he called for vaccine companies to be encouraged to transfer technology to developing countries.

Two Chinese vaccines, one from Sinovac Biotech and one from Sinopharm, have been included in the WHO's emergency use list.

Xi also called for policies to maintain global economic and financial stability, saying China will strengthen macroeconomic policy coordination and maintain policy continuity, stability and sustainability.

"Major economies should adopt responsible macroeconomic policies to avoid negative spillover effects to developing countries and maintain the steady operation of the international economic and financial system," he said.

Xi reiterated that China would work to hit a carbon emissions peak by 2030, with the goal of reaching carbon neutrality by 2060.

https://www.marketscreener.com/quote/stock/SINOVAC-BIOTECH-LTD-5714593/news/China-s-Xi-calls-for-COVID-19-vaccine-mutual-recognition-36845559/

How COVID-19 alters the immune system

 COVID-19 reduces the numbers and functional competence of certain types of immune cells in the blood, say LMU researchers. This could affect responses to secondary infections.

The SARS-CoV-2 coronavirus causes moderate to severe disease in 3–10% of those infected. In such cases, the immune system overreacts to the virus, triggering an aberrant innate immune response that is characterized by systemic inflammation, intravascular blood clotting and damage to the cardiovascular system. A team led by immunology professor Anne Krug at LMU's Biomedical Center (BMC), which included many researchers based at the BMC and the LMU Medical Center, has carried out a comprehensive study of this phenomenon, and uncovered hitherto unknown effects of the virus on the immune system. In the journal PLOS Pathogens, they report that, following infection with SARS-CoV-2, the numbers of immune cells called dendritic cells in the circulation decline, while the functionality of the remaining fraction is impaired. The authors believe that this could make patients more susceptible to secondary infections during, and immediately after recovery from a bout of COVID-19.

Dendritic cells (DCs) are responsible for initiating immune responses against invasive pathogens. They do so by activating helper T cells, which in turn stimulate B cells to secrete antibodies directed against the invader. Krug and her colleagues set out to determine the effects of moderate to severe coronavirus infection on this process. They analyzed blood samples obtained from 65 COVID-19 patients who had been treated at the LMU Medical Center. They found that there were fewer DCs in these samples than in the blood of healthy controls. Furthermore, DCs isolated from the blood of patients showed a reduced ability to activate T cells. "We had actually expected that DCs isolated from patients infected with SARS-CoV-2 would activate T cells more potently than DCs obtained from healthy donors," says Krug. "However, we discovered that, in the course of the disease, the proteins present on the surface of the DCs in patients' blood were altered in a way that made them more likely to inhibit T cell responses." In spite of this, by 15 days after diagnosis 90% of these patients had generated antibodies directed against the SARS-CoV-2 spike protein, and many of them had also activated a T cell response. – these responses are the hallmarks of a robust immune reaction against the virus. "So, the drop in the numbers and reduced functionality of DCs does not seem to have a negative impact on the immune response to the coronavirus itself," Krug says.

However, she is convinced that the reduced number and altered function of DCs is significant. It is conceivable that this might cause the immune system to react less strongly than expected to bacterial or other viral infections following recovery from COVID-19, but this possibility will require further clinical investigation.

What might account for the depletion of DCs in the blood and the decrease in their capacity to stimulate T cells? – Krug has several hypotheses to offer. It could in fact represent an appropriate regulatory process, she suggests. COVID-19 is often associated with vigorous inflammation reactions—so the phenomenon might be part of an attempt to downregulate inflammatory processes. Dendritic cells might migrate from the blood into inflamed tissues, such as the lung, which could explain the fall in the numbers of DCs in the circulation. "However, we also found that the regeneration of dendritic cells is delayed," Krug points out. The authors of the study believe that this phenomenon could weaken the ability of patients to mount effective immune responses to other pathogens during, and in the immediate aftermath of a symptomatic COVID-19 infection. The team will now explore this issue further in an effort to determine whether the effects of SARS-CoV-2 on DCs play a role in long-term COVID.

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Cancer patients with poor antibody response to COVID-19 vaccines also lack secondary immune response

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More information: Elena Winheim et al, Impaired function and delayed regeneration of dendritic cells in COVID-19, PLOS Pathogens (2021). DOI: 10.1371/journal.ppat.1009742

https://medicalxpress.com/news/2021-10-covid-immune.html