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Sunday, August 14, 2022

llumina sets aside $453M to prep for potential EU fines over Grail

 The DNA sequencing giant said it has set aside nearly half-a-billion dollars to prepare for potentially hefty fines levied by the European Commission, after the company closed its deal nearly one year ago this month without waiting for the approval of international competition watchdogs.

That includes $453 million in what the company described as “legal contingencies” logged in the second quarter this year—or prior to the EU General Court's ruling in mid-July that the commission's antitrust probe, which Illumina had challenged, could indeed continue.

They also came ahead of the commission officially alleging that Illumina had breached its so-called standstill regulations, requiring mergers to wait for final approval. If found guilty of violating those rules, fines could reach up to 10% of Illumina and Grail's total annual revenue. 

In its second quarter earnings report, Illumina also earmarked another $156 million to be put toward settlements for patent cases with the Chinese DNA sequencer maker BGI Group. According to BGI's affiliate company MGI, both sides agreed to drop their litigation while Illumina will make a net payment of $325 million in return for patent licenses.

That combined $609 million in rainy-day money dragged Illumina's quarterly income into the red. 

The company, incorporating figures from Grail, posted a total net loss of $535 million including R&D and operating expenses, after raising about $1.2 billion in revenue. Sales were up just 3% compared to the same three months in 2021, which had seen $187 million in net income. Without the legal contingencies, Illumina would have collected about $30 million in operating profits.

“Our second quarter results were impacted by macroeconomic challenges that we expect to play out over the next couple of quarters,” CEO Francis deSouza said on a call with investors. 

That includes global supply chain pressures for other pieces of equipment that have delayed some users' plans for expanding their laboratories, while other customers have pulled back on spending altogether and trimmed down their inventories of Illumina products, de Souza said, adding that he expects them to return in 2023.

“But in the end, their demand and their activity levels are going to match what we are seeing from the data we get from monitoring their instruments,” he said. “And there the activity, and therefore the demand, continues to be very robust.”

“The activity levels that we're monitoring on the high- and mid-throughput instruments reflected a growth rate in runs that are greater than 15%.”

Illumina and Grail recently passed another one-year anniversary: the launch of the latter's Galleri screening test, designed to detect the evidence of as many as 50 different cancers from a single blood draw.

Galleri began its commercial rollout in June 2021 after years of research and about $2 billion in venture capital funding. The test is designed to screen people who may already have an elevated risk for cancer, such as adults over the age of 50.

Currently managed as an owned but wholly separate subsidiary—pending the final decisions of antitrust regulators—Grail tallied $12 million in revenue for the quarter, compared to an operating loss of $187 million. However, deSouza said that in Galleri's first 12 months on the market it “delivered the fastest ever first-year revenue ramp of a cancer screening test.”

Despite that, the company is tampering its financial expectations for the remainder of 2022. Illumina's forecasts for Grail's full year revenue shrank to between $50 million and $70 million, down from the $70 million to $90 million it predicted earlier this year. 

Meanwhile, for its core DNA business, Illumina is now projecting revenue growth in the range of 4% to 5%, down from the 14% to 16% it estimated at the end of 2021's first quarter. 

But as to how Illumina and Grail will proceed if European regulators order the companies to be split in two? DeSouza said the company is still working on that plan. 

“There's obviously a set of nodes on the decision tree that would lead us to either spinning out Grail because the regulatory process doesn't go our way, or contemplate other forms of exits,” he said on the investor call. 

To make sure Grail has the money it needs to complete its cancer-testing mission, it could receive investments from Illumina—which previously owned a percentage of the company following its birth as a spinout from the DNA sequencing giant in 2015—plus potential backing from other shareholders.

“That's going to be a combination of Illumina, but other shareholders and people who would inject capital both at the time of divestiture, and then over time as well,” deSouza said. “How would we set it up to be successful, and what's the path for it to continue to be successful? Obviously, those are not decisions that we're making today, but those are some of the considerations that would go into it.”

https://www.fiercebiotech.com/medtech/illumina-sets-aside-453m-prep-potential-eu-fines-over-grail-acquisition

82 teachers accused of using fake vax cards ordered back on city payroll

 The city Department of Education has agreed to put 82 teachers suspected of submitting fake COVID-19 vaccine cards back on the payroll pending an internal probe, The Post has learned.

The teachers are believed to have skirted the city’s vaccine mandate, which required every municipal worker to show proof of vaccination or be terminated, unless granted a religious or medical exemption. Close to 1,000 DOE employees who refused to comply have been fired.

The DOE suspended the 82 teachers without pay on April 25 after their names popped up as customers of a Long Island pediatric center accused of selling bogus vaccine cards.

The nurse practitioner-owner and two staffers at Wild Child Pediatric Healthcare were charged with racking up $1.5 million in sales, charging adults $220 for each dose falsely marked on the card, or $440 for both doses, according to the Nassau County District Attorney’s office.

None of the teachers has been arrested. Several who spoke to The Post on condition of anonymity insisted they did get inoculated against COVID-19, but paid the fees for a “detox treatment” to offset any adverse reaction.

One of the vaccine cards that authorities claimed was fake.
One of the vaccine cards that authorities claimed was fake.

The DOE filed a suit last month seeking to keep the suspected cheats suspended without pay. The United Federation of Teachers argued it was improper to do so based on unproven allegations.

Last week, the DOE buckled, telling the exiled educators they would be placed back on the city payroll on Sept. 6, the first day of the new school year.

“Upon your return, the DOE will conduct an internal investigation related to whether the proof you uploaded is fraudulent,” an internal memo says.

“This is a huge step for an agency that never admits they did anything wrong,” said Betsy Combier, a paralegal who is helping defend the teachers.

The staffers still can’t return to their classrooms or schools, but have to sit in an isolated holding area. They will be told to where to report after Sept. 1, the memo says.

https://nypost.com/2022/08/13/82-teachers-accused-of-using-fake-vax-cards-ordered-back-on-city-payroll/

Walgreens is offering up to $75,000 to recruit pharmacists amid shortage

 Pharmacists are in such high demand that Walgreens is offering a hefty signing bonus of up to $75,000. 

The Wall Street Journal reported Thursday that typically Walgreen signing bonuses are around $30,000 or $50,000. But due to pandemic-related staffing challenges, the signing bonus can be up to $75,000 in certain markets across the U.S.

“This is one of many steps to address pharmacy staffing in some areas, in order to best meet the needs of our customers and patients, as well as recognizing our current pharmacy staff for their hard work and dedication,” Walgreens said in a statement to Fox News.

However, new hires are required to stay on the job for at least a year to receive the bonus.

The median annual salary for pharmacists was $128,570 in 2021, according to the U.S. Bureau of Labor Statistics. 

https://nypost.com/2022/08/12/walgreens-is-offering-up-to-75000-to-recruit-pharmacists-amid-shortage/

Shanghai to reopen all schools Sept. 1 as lockdown fears persist

 


China's financial hub Shanghai said on Sunday it would reopen all schools including kindergartens, primary and middle schools on Sept. 1 after months of COVID-19 closures.

The city will require all teachers and students to take nucleic acid tests for the coronavirus every day before leaving campus, the Shanghai Municipal Education Commission said.

It also called for teachers and students to carry out a 14-day "self health management" within the city ahead of the school reopening, the commission said in a statement.

Shanghai shut all schools in mid-March before the city's two-month lockdown to combat its worst COVID outbreak in April and May.

It allowed some students at high schools and middle schools to return to classrooms in June while most of the rest continued home study for the remainder of the semester.

The announcement on schools reopening brings great relief to many residents but fears about COVID lockdowns continue to persist, as China vows to stick to its dynamic zero policy which requires all positive cases and their close contacts to undergo quarantine.

On Saturday, videos circulating on Chinese social media showed customers pushing past security guards and running out of an IKEA mall in central Shanghai in panic as an announcement blared over its sound system saying the mall was being locked down due to COVID contact tracing.

Reuters was not able to independently verify the authenticity of the videos, but IKEA customer service said on Sunday the mall was shut due to COVID curbs. IKEA did not immediately respond to a request for further comment.

Shanghai, the most populous in China, reported five new local infections of COVID, all asymptomatic, for Saturday, while 2,467 domestically transmitted cases were reported nationwide.

It has extended its weekly COVID-19 test requirement and extended free testing until the end of September in a bid to keep the virus in check, authorities announced on Saturday.

The southern province of Hainan is now China's worst hit region, with 494 symptomatic cases and 846 asymptomatic cases reported for Saturday.

Chinese Vice Premier Sun Chunlan urged Hainan to achieve zero cases at the community level as soon as possible when she inspected several places on the island, including the Sanya Phoenix International Airport on Saturday, state media reported.


https://www.voanews.com/a/shanghai-to-reopen-all-schools-sept-1-as-lockdown-fears-persist/6700897.html

High cholesterol: Verve CRISPR treatment trial could offer permanent cure

 

  • Cardiovascular disease is the number one cause of death in the world.
  • High cholesterol is a modifiable risk factor for heart-related diseases.
  • Biotechnology company Verve Therapeutics recently launched an in-human clinical trial for a gene-editing medication aimed at lowering cholesterol.

Cardiovascular disease is the number one cause of death worldwide. In 2019, about 17.9 million peopleTrusted Source worldwide died from heart-related diseases.

A common and modifiable risk factor for cardiovascular disease is high cholesterolPast researchTrusted Source shows if a person reduces their cholesterol by 10%, they can lower their risk for heart-related issues by up to 30%.

Although there are currently medications available to help lower cholesterol, they can sometimes have side effects. Additionally, these therapies normally require a person to take them every day, which causes decreased prescription adherenceTrusted Source for some patients.

To provide a different type of treatment for lowering cholesterol, biotechnology company Verve Therapeutics has recently launched a clinical trial in New Zealand to test a new single-dose gene-editing medication in human patients.


The base of Verve Therapeutics’ new treatment is genetic editing tool called CRISPRTrusted Source, which stands for Clustered Regularly Interspaced Short Palindromic Repeats. Through the use of this technology, it is possible to change a person’s DNA and ultimately alter how certain genes function.

CRISPR technology uses the same type of gene editing bacteria naturally used as a defense mechanism. If a bacteria becomes infected by a virus, it takes a small piece of the virus’s genetic code. It then inserts that small piece of code into its DNA in a specific pattern called a CRISPR arrayTrusted Source. If the virus attacks again, the bacteria can now recognize the virus and make pieces of RNATrusted Source that attack the virus’ DNA, helping to protect the bacteria from infection.

The CRISPR gene editing tool was first discovered in 2012. Since then, researchers have used the technology in multipple mouse-model studies as a treatment for diabetesHIVTrusted Source, and muscular dystrophy.

In 2017, scientists used CRISPR technology to repair a disease-causing mutation in viable human embryosTrusted Source.

In 2016, Chinese scientists were the first to deliver a CRISPR therapy to a human to test the use of CRISPR gene editing in people with lung cancerTrusted Source.

Since then, there have been more human trials with therapies based on CRISPR technology. In March 2020, a human receivedTrusted Source CRISPR-based gene therapy during a clinical trial for the eye disease Leber’s congenital amaurosis 10Trusted Source. And in 2021, conducted a clinical study for a CRISPR treatment for sickle cell disease.

The current clinical trial for Verve Therapeutics’ VERVE-101 gene editing treatment, known as the heart-1 clinical trial, examines the medication as a treatment for patients with heterozygous familial hypercholesterolemiaTrusted Source (HeFH).

HeFH is an inherited genetic disorder affecting the liver and ultimately causing very high levels of cholesterol in the body if not treated. HeFH is a subtype of atherosclerotic cardiovascular diseaseTrusted Source (ASCVD), where blood vessel walls become thick and hard, making it difficult for blood to flow freely.

According to Verve Therapeutics’ website, VERVE-101 works by targeting a specific gene in the liver called the PCSK9 gene. The treatment edits the PCSK9 gene to turn it off. This results in lower levels of “bad” cholesterol — known clinically as LDL-CTrusted Source — in the blood.

“Our ultimate goal with VERVE-101 is to bring a new option to the millions of people with ASCVD around the world, and dosing participants in the Phase 1 study for this first indication, HeFH, is a key inflection point to achieving that goal,” said Dr. Andrew Bellinger, chief scientific and medical officer of Verve, in a press release.

“With the current standard of care treatment for HeFH, less than 20% of patients achieve LDL-C goal levels due to the limitations of the chronic model which requires rigorous patient adherence, regular health care access, and extensive health care infrastructure. VERVE-101 has the potential to change the way cardiovascular disease is cared for by lowering LDL-C as low as possible for as long as possible after a single treatment,” he stated in the release.

The clinical trial reportedly includes 40 adult patients with HeFH and established ASCVD. Verve Therapeutics plans to release clinical trial data in 2023.

Before launching this clinical study, Verve Therapeutics released preclinical data from its study of VERVE-101 on non-human primates. The company presented these findings at the TIDES USA 2022 Oligonucleotide & Peptide Therapeutics Conference in May 2022.

Preclinical data reportedly showed a more than 60% mean reduction in LDL-C after 20 months of a non-human primate receiving a single dose of the therapy.


MNT spoke with Dr. Christie Ballantyne, chief of cardiology and cardiovascular research at Baylor College of Medicine. He commented this is an exciting first step in research to examine if single-base gene editing would offer lifelong lowering of LDL-C.

“Gene editing would offer potentially a one-time treatment and overcome the problems that we face with adherence to chronic treatment of lipidsTrusted Source,” Dr. Ballantyne explained.

Dr. Rigved Tadwalkar, a board certified cardiologist at Providence Saint John’s Health Center in Santa Monica, CA, agreed.

“The biggest problem we have with currently available therapies for lowering cholesterol is that adherence is low,” Dr. Tadwalkar explained to MNT. “This is for several reasons, but chiefly the standard of care, which are statinsTrusted Source, need to be taken daily. And there are many people who aren’t great with following that routine.”

When asked what the potential risks for a gene-editing therapy might be, Dr. Tadwalkar stated although the technology should be safe, there are some concerns to consider.

“The concern is that if an off-target base is edited and renders a different and possibly important gene nonfunctional, or worse yet causes some other terrible anomaly, this could really be devastating theoretically,” he detailed. “While this shouldn’t happen, the specific effects of a therapy in a human can often be different than that as seen in other organisms, so we can’t just extrapolate based on information that we have from other organisms. There’s also an aspect of irreversibility associated with this that should be taken into account.”

“I honestly feel like if it works as intended, it should not present a large issue, as we have seen with other PCSK9-based therapiesTrusted Source,” Dr. Tadwalkar added. “When we remove this protein, people tend to do very well, and we have great long-term outcomes.”

And Dr. Ballantyne said he would like to see data on the efficacy and tolerability of the CRISPR-based treatment and dose-response after the clinical trial concludes.

“Phase 1 trials are very small and not powered to tell us much about safety — this issue requires much larger and longer studies,” he added.

https://www.medicalnewstoday.com/articles/high-cholesterol-new-crispr-treatment-trial-could-offer-permanent-cure#CRISPR-and-future-of-cholesterol-treatment

New drug candidate may be effective against 200+ antibiotic-resistant bacteria

 

  • Researchers modified an existing antibiotic to create a new molecule that may be effective against Gram-negative bacteria that are drug resistant.
  • One molecule synthesized by the researchers, fabimycin, showed promise in combating more than 200 Gram-negative bacteria and didn’t have a significant impact on the harmless bacteria that are typically present in the human gut microbiome.
  • Fabimycin also showed efficacy against Gram-negative bacteria in mouse infection models of a challenging urinary tract infection (UTI) and acute pneumonia.
  • Findings suggest that fabimycin could eventually be used to treat Gram-negative infections in humans.

Bacterial antimicrobial resistance (AMR) occurs when bacteria mutate over time and no longer respond to antibiotics, making infections more difficult to treat and increasing the risk of disease spread, severe illness, and death. Scientists have described infections due to antibiotic-resistant bacteria as a threat to modern healthcareTrusted Source.

Bacteria can be categorized as Gram-positive or Gram-negative based on the structure of their cell membranesTrusted Source.

In 1884, a Danish bacteriologist named Hans Christian Gram developed a test to differentiate bacteria based on the chemical and physical makeup of their cell walls. Gram found that some bacteria had a thin peptidoglycan cell wall, in addition to a dense outer membrane and efflux pumps. These bacteria were categorized as Gram-negative, and their cell structure prevents antibiotic molecules from entering and accumulating within the cell. In comparison, Gram-positive bacteria lack the outer layer, but are surrounded by thick layers of the mesh-like peptidoglycan.

Due to the cell structural difference, Gram-negative bacteria, such as pneumoniaurinary tract infections (UTI), and bloodstream infections, are harder to treat compared to those caused by Gram-positive bacteria.

In 2017, the World Health Organization (WHO) identified a list of antibiotic-resistant priority pathogensTrusted Source that present a “great threat to human health.” The agency highlighted the urgency of the need for new antibiotics. A majority of the pathogens listed by the WHO are Gram-negative bacteria.

Gram-negative bacteria also include four out of the six most lethal drug-resistant pathogensTrusted Source.

Dr. Paul J. Hergenrother, professor of chemistry at the University of Illinois, and his team of researchers, sought to create an antibiotic that would successfully accumulate in Gram-negative cells. 

Dr. Hergenrother and his team decided to target the FabI enzyme, which is responsible for catalyzing the rate-determining step in bacterial fatty acid biosynthesis. Before this study, the use of the FabI enzyme as an antibiotic target had only been leveraged in Gram-positive infections. 

The results of this study appear in ACS Central Science.


Researchers have come to understand that the physicochemical traits of small molecules impact their ability to penetrate and accumulate inside Gram-negative bacterial cells. This emerging knowledge is captured in new guidelines for the design of Gram-negative penetrant compounds, known as the . 

Dr. Hergenrother’s team started with Debio-1452, a FabI inhibitor highly potent against Gram-positive Staphylococcus aureus. Guided by the eNTRy rules, the researchers made structural modifications to the Debio-1452 molecule with the objective of creating a new molecule that retained the FabI inhibition potency of Debio-1452 but also possessed activity against Gram-negative bacteria. 

Out of a suite of newly-synthesized Debio-1452 drug candidates, one molecule — which the researchers coined fabimycin — showed superior potency in initial tests.


Having identified fabimycin as the most promising Gram-negative antibiotic candidate, the researchers assessed the antibacterial activity of fabimycin against a panel of multidrug-resistant Gram-negative clinical isolates.

They found that fabimycin has impressive activity against more than 200 clinical isolates of Escherichia coliKlebsiella pneumoniae, and Acinetobacter baumannii.

Fabimycin also exhibited a narrow range of minimum inhibitory concentrations (MICs) among all the clinical isolates Fabimycin also exhibited a low and narrow range of minimum inhibitory concentrations (MICs) compared to the other clinical isolates tested. MIC is the lowest concentration of an antibiotic that inhibits bacterial growth.

This result encouraged the authors “because it suggests that intrinsic resistance to fabimycin is not prevalent in existing bacterial populations.”

Furthermore, fabimycin demonstrated high specificity for pathogenic versus commensal bacteria (normal microflora). The researchers attribute this to the fact that commensal bacteria may not be reliant on the FabI enzyme and would thus be insensitive to FabI enzyme inhibition by fabimycin.

This discovery suggests that fabimycin could be less damaging to gut microflora than typical broad-spectrum antibiotics.


After establishing an effective dose of fabimycin in mice, the researchers evaluated the efficacy of fabimycin in mice infected with a challenging, drug-resistant strain of Escherichia coli. This bacterium causes the vast majority of UTIs.

By administering fabimycin intravenously three times a day, the researchers were able to reduce the amount of drug-resistant bacteria in the spleen, bladder, liver, and kidney tissues of mice to pre-infection levels or below.

In their paper, the researchers noted that there had not been a novel class of antibiotics FDA-approved for treatment of Gram-negative pathogens” in more than half a century, putting the discovery of fabimycin into perspective.


The high potency of fabimycin against Gram-negative clinical isolates, low frequency of bacterial resistance, and efficacy in mouse infection models bode well for its efficacy in humans. 

The successful synthetic strategy presented in this study provides evidence that existing antibiotics effective against Gram-positive bacteria may be modified to penetrate and kill Gram-negative bacteria.

Dr. William M. Wuest, Georgia Research Alliance Distinguished Investigator and professor of chemistry at Emory University, expressed enthusiasm for the paper and its potential to be translated into an effective treatment for stubborn Gram-negative infections. However, he highlighted that “significant financial investment [is needed] to make it happen, and historically that has been challenging in the antibiotic field.”

“We are in dire need of new antibiotics that target new bacterial processes and the work by the Hergenrother group identifies one such compound,” said Dr. Wuest. “Their results are very exciting and have the potential to proceed to the clinic given the right financial support from the community.”

When asked how this research will progress, Dr. Hergenrother told MNT, “The next step is to work with a suitable commercial partner on IND-enabling studies as part of advancing this technology to the clinic.”

https://www.medicalnewstoday.com/articles/new-drug-candidate-may-be-effective-against-200-antibiotic-resistant-bacteria

Dems on dangerous path with drug pricing

 The passage of Democrats’ sweeping economic package — which is designed to combat climate change, address health care costs and reduce the deficit by raising taxes on corporations — is a major win for President Biden’s agenda.

Further, Democrats’ push to pass a $35 insulin cap for non-Medicare patients was the right move both practically and politically — even though it was ultimately unsuccessful — as they forced Republicans to either side with them or to go on record voting against a policy that would cut costs for millions of Americans with diabetes.

Democrats’ final legislation makes a historic investment in clean energy, which will help the U.S. cut greenhouse gas emissions by 40 percent by 2030. It also extends expanded subsidies under the Affordable Care Act and realizes the party’s long-sought goal of allowing Medicare to “negotiate” prescription drug prices directly with pharmaceutical companies.

Proponents claim that enabling Medicare to negotiate prices will lower the cost of prescription drugs for the nearly 64 million Americans who are currently on Medicare, and more specifically for the 1.4 million beneficiaries who spend more than $2,000 per year on their medications.

Regrettably, this is a misguided assessment that fails to consider how this policy will actually decrease both the affordability and accessibility of prescription drugs in the long run.

Democrats’ drug pricing policy won’t improve the problem that it is designed to address — making prescription drugs more affordable for Medicare beneficiaries — and it will end up limiting Medicare patients’ access to certain medications. Moreover, it will discourage pharmaceutical innovation, and worst of all will drive costs up for the 220 million Americans with private insurance.

Indeed, this policy will raise drug costs and health care premiums for the 220 million Americans with private health insurance. If drugmakers are forced to give Medicare significant discounts on certain drugs, these companies will make up for this lost revenue by raising prices in the commercial market, as “The Wall Street Journal’s” Editorial Board argued in their column earlier this week.

If hundreds of millions of Americans with private insurance are paying more for their medications — as well as for their hospital and physician services — Democrats’ “Inflation Reduction Act” will do nothing of the sort and could end up exacerbating the problem.

While Democrats did attempt to include a broad-based rebate if drug prices increase at a faster rate than inflation, the Senate parliamentarian struck this provision down, and Sen. Majority Leader Chuck Schumer (D-N.Y.) went forward with the bill anyway.

In addition to driving costs up for the majority of Americans, the policy won’t provide relief for most Medicare recipients. The bill’s $2,000 out-of-pocket cap for Medicare Part D patients will help just a small fraction of beneficiaries and doesn’t even take effect until 2026. Even then, the policy will begin by addressing only ten of the most expensive drugs on the market.

The policy’s focus on big drug manufacturers, who make brand-name medications, will also inject uncertainty into the market and engender perpetual monopolies. It will make it harder for lower-cost generic drugs — which make up almost 90 percent of all filled prescriptions in the United States — to gain entry and compete in the market, driving up prescription drug prices for all Americans over time.

Furthermore, this policy will ultimately limit Medicare patients’ access to life-saving treatments. It gives drug manufacturers impossible requirements to meet — namely, if a manufacturer does not agree to sell at the government’s mandated price, they will be forced to either pay a 95 percent tax on the sales or pull their medication off the market.

In the long run, this reform will also stifle medical and pharmaceutical innovation, curtailing all Americans’ access to life-saving drugs, especially seniors.

Continuing research following a medicine’s approval — or rejection — allows researchers to understand if a medication works at a different stage of an illness or for a different condition. This is especially important when it comes to treating cancer — as nearly 60 percent of oncology medications approved a decade ago received additional approvals for different types of cancer in the years to follow.

The Senate’s bill takes away the incentives that are necessary to encourage the continual investment in new cures by setting the price of medication before these advancements can be made. This will hurt seniors the most, as it disincentivizes drug makers from constantly investing in researching drugs that fall under Medicare coverage.

In order to more effectively minimize costs and maximize access, Democrats should be focused on promoting drug pricing reforms that eliminate inefficiencies and foster competitiveness in the marketplace.

This would involve cracking down on pharmacy benefit managers (PBMs), which are third-party administrators of prescription drug programs, who reap the benefits of rebates instead of American patients. Oftentimes, PBMs receive more money from insurers than was paid for the medicine.

By cutting out these middlemen — PBMs — Americans would be able to purchase prescriptions straight from the supplier, eliminating markups or unnecessary price hikes. This approach has been successfully undertaken in the private sector, as billionaire Mark Cuban’s venture — Cost Plus Drugs — offers more than 100 generic drugs at affordable prices by removing pharmacy benefit managers from the equation.

While there are many helpful reforms in the Democrats’ economic package, their drug pricing policy, unfortunately, misses the mark. All Americans will bear the brunt of increased prices and decreased access, ironically, seniors will be hit the hardest.

Douglas E. Schoen is a political consultant who served as an adviser to former President Clinton and to the 2020 presidential campaign of Michael Bloomberg. He is the author of “The End of Democracy? Russia and China on the Rise and America in Retreat.” 

https://thehill.com/opinion/healthcare/3598491-democrats-are-on-a-dangerous-path-with-drug-pricing/