NHS is in "serious trouble" says Darzi report

 A report on the state of the NHS in England by former Labour Health Minister Lord Darzi has concluded that it is in a dire state – which will come as a surprise to nobody – and has problems that could take up to eight years to fix.

The report was commissioned by new UK Health Secretary Wes Streeting days after coming into office, who said it was important to understand the true state of the NHS before embarking on reforms. Now, it will form the basis of a 10-year plan to get the health service back on track.

While the NHS is in a "critical condition" – with expanding waiting lists, missed targets for A&E and hospital treatments, and poor survival rates for cancer and heart disease – "its vital signs are strong," according to Darzi, an eminent surgeon at Imperial College London who also led an NHS review in 2008 under the previous Labour government.

That is thanks to the quality, passion, and determination of the NHS workforce, as well as "more resources than ever before," according to the 163-page report (PDF), which blames the parlous state of the NHS on years of austerity in the 2010s after the Conservatives came into power and a chronically starved capital budget.

"Although I have worked in the NHS for more than 30 years, I have been shocked by what I have found during this investigation – not just in the health service, but in the state of the nation's health," writes Darzi.

Among the key problems highlighted in the report is that too much of the NHS budget is being spent in hospitals, with too little going to community health services and GP services increasingly stretched, along with poor productivity as workers waste their time solving "process problems," like trying to find available beds.

With 2.8 people out of work due to illness – up 800,000 on pre-pandemic levels – the nation's health is harming national prosperity. Meanwhile, the service has largely missed a decade-long opportunity to digitise its processes and move from a 'diagnose and treat' model to 'predict and prevent.'

"I would note that the NHS has been through very difficult times in the past and has emerged stronger," according to Darzi. "It has taken more than a decade for the NHS to fall into disrepair, so improving it will take time."

His solutions include redirecting some of the budget towards general practice, mental health, and community services – and crucially locking in those changes so they stick long-term – to encourage a simpler, neighbourhood-based NHS model.

Hospital productivity must be addressed to tackle waiting lists (now at 7.6 million) and rebuild capacity, helped with technology like digitalisation and AI that will help tap into the value of NHS health data.

Responding to the document in a BBC interview, Streeting has confirmed the government will shift the balance in funding in favour of neighbourhood services, accelerate the switch from analogue to digital services, and shift the emphasis from treatment to prevention.

Details of the government's response, however, will have to wait for the Autumn Budget announcement on 30th October, and the full 10-year plan isn't scheduled to be published until spring next year.

Industry needs support

In good news for the life sciences sector, the report also says specifically that UK biopharmaceutical companies need to be better supported, saying: "For the NHS, partnerships with the life sciences sector for research or treatment too often fall into the category of 'important but not urgent'."

"It has simply not been a high enough priority in a world where waiting lists are long, and finances are tight," it goes on. "But in the medium term, it is innovation that can make the NHS more sustainable."

The Association of the British Pharmaceutical Industry (ABPI) welcomed that assertion, saying it is ready to be an "active partner" in helping to fix the NHS.

"This hard-hitting report makes clear the huge pressure the NHS is under, but also highlights that it is innovation that can make the NHS more sustainable," said ABPI chief executive Richard Torbett.

"Turning the NHS around will require radical thinking, including investing in prevention, boosting NHS revenues through attracting more clinical research, partnering with industry to speed up diagnosis, and streamlining access to treatment."

https://pharmaphorum.com/news/nhs-serious-trouble-says-darzi-report

GSK drops HSV jab, leaving rival mRNA shots in pole position

 GSK has abandoned its clinical-stage vaccine for herpes simplex virus (HSV) after a disappointing phase 1/2 trial, ceding the ground to mRNA shots in development at Moderna and BioNTech.

After completing the primary data analysis from the phase 2 portion of the TH HSV REC-003 study in patients with recurrent genital herpes, the pharma group found that the efficacy of the GSK3943104 vaccine was not sufficient to warrant advancing it into a phase 3 programme, although it had a clean safety profile.

The trial was designed to enrol around 340 adults aged 18 to 60, with the main efficacy objective the ability of the jab to extend the time to recurrence of genital herpes lesions.

The company acknowledged the "unmet medical need and burden" associated with HSV, but said it would look at the "totality of data" before making a decision on the future of its HSV programme.

According to the World Health Organization (WHO), around 491 million people between the ages of 15 and 49 have HIV type 2 – the form of the virus that mainly causes genital herpes – which is around 13% of the world's population.

While most HSV infections are asymptomatic and can be undiagnosed, infection with HSV-2 recurrent lesions on the genitals occur in some patients and having the infection increases the risk of acquiring and transmitting other diseases, including HIV.

Recurrent genital herpes causes a reduction in quality of life, which antivirals – the current standard of care – can only partially restore, leading to a pressing need for alternative options.

The demise of GSK3943104 – which was being tested as a therapeutic vaccine in TH HSV REC-003 – means that mRNA vaccines from Moderna and BioNTech are now out in front in the HSV vaccine development race.

Moderna said earlier this year that its HSV shot – codenamed mRNA-1608 – had started a first-in-human phase 1/2 trial to establish safety and proof-of-concept efficacy in around 365 adults 18 to 55 years of age with recurrent genital herpes. Results from the study are due next year.

BioNTech, meanwhile, said towards the end of 2022 that it had started dosing patients in a first-in-human phase 1 trial of BNT163, an HSV-2 vaccine intended for the prevention of genital lesions caused by HSV-2 and potentially HSV-1.

The history of HSV vaccine development is littered with failures, mainly because HSV infections are prone to latency – hiding away in reservoirs in the body that protect them from immune responses.

GSK abandoned an earlier candidate called Simplirix more than a decade ago, while others from Vical, Agenus, Vir Biotech, and Genocea Biotech have also fallen by the wayside.

https://pharmaphorum.com/news/gsk-drops-hsv-jab-leaving-rival-mrna-shots-pole-position

UK Starmer says no extra NHS funding without big reforms

 UK Prime Minister Keir Starmer has promised the biggest 'reimagining' of the NHS in its history but stressed there would be no more funding without sweeping reforms.

The comments – made in the wake of the publication of the much-anticipated Darzi report on the NHS this morning – came as the government said it would publish a 10-year plan next year built around three key themes – moving care from hospitals to communities, transitioning to a digital service, and a focus on prevention rather than treatment.

Taking the previous Conservative government to task, Starmer highlighted the long-term impact of the 2012 Health and Social Care Act – described by Darzi as "a calamity without international precedent" and "disastrous," as well as the consequences of underinvestment throughout the 2010s under the then government's austerity policies.

"It is unforgivable, and people have every right to be angry – not just because the NHS is so personal to all of us, or because when people can't get the care they need and are off sick, it is a huge cost to our economy, but because some of these failings are literally life and death," he said.

"Crumbling buildings, decrepit portacabins, mental health patients accommodated in Victorian-era cells infested with vermin," continued the PM. "The 2010s were a lost decade for our NHS… which left the NHS unable to be there for patients today, and totally unprepared for the challenges and opportunities of tomorrow."

Hitting back, the Conservatives have accused the government of "political posturing" and said it must turn its rhetoric into action after abandoning policies introduced under the previous administration, including social care reform and plans to build new hospitals.

The solution is "major surgery, not sticking plaster solutions," said Starmer, who pledged that all reforms would not be a top-down approach but would have "the fingerprints of NHS staff and patients all over it."

Among the priorities highlighted in the speech at the King's Fund annual conference was a need to improve the UK's dismal performance on avoidable and preventable mortality, tackle ill health as a brake on economic productivity, and reduce pressures on the NHS.

"The NHS is the right model, but it's not taking advantage of the opportunities in front of it," said Starmer, promising to keep to the principles of providing a health service that is taxpayer-funded, free at the point of use, and based on need not ability to pay. "No more money without reform. We have to fix the plumbing before we turn on the taps."

The British Medical Association concurred with Starmer's assessment of the previous government's record and called for "continued progress on restoring doctors' pay, preventing the loss of junior doctors to other countries that truly value their contributions and removing absurd pension rules that discourage senior doctors from taking on the extra shifts needed to reduce waiting lists."

The Association of the British Pharmaceutical Industry (ABPI) also welcomed a promise to put "the full weight of the British government behind our world-leading life sciences", but stressed that making better use of new medicines and vaccines has to be "part of the picture."

The trade body's chief executive Richard Torbett said that, in return: "We can't wait to throw our weight behind the NHS's, and society's, recovery."

Meanwhile, the general manager of Sanofi UK & Ireland's vaccine business, Rebecca Catterick, called on the government to make changes to the ecosystem to vaccinations as a key part of its prevention drive, pointing out that falling rates of immunisation is identified in the Darzi report as one of the most serious dangers posed to children's health.

https://pharmaphorum.com/news/starmer-says-no-extra-nhs-funding-without-big-reforms

NH signs bill tightening voter ID laws for future (post Nov. 5) elections

 New Hampshire Gov. Chris Sununu (R) signed a bill that tightens voter ID laws in the state for future elections.

The much-debated bill requires voters to provide proof of U.S. citizenship when registering to vote. Individuals must also show voter ID before voting.

The law won’t go into effect for 60 days after this fall’s Nov. 5 general election.

The bill was passed by New Hampshire’s Republican-led Legislature in May. It was in limbo for months until Sununu signed it Thursday.

Sununu said the bill will promote trust in elections, despite insisting the state’s elections are well-run, safe and secure, The Boston Globe reported.

The Hill has reached out to Sununu’s office for comment, but in a statement reported by the Globe, the governor said New Hampshire has a “proud transition and proven track record of conducting elections that are trusted and true.”

“Looking forward to the next decade or two, this legislation will instill even more integrity and trust in the voting process,” Sununu said in the statement.

In a post on social platform X, state Rep. Angela Brennan (D) said the bill is unconstitutional that and she and Republican state Sen. Jim Gray oppose it.

“Expect extensive and expensive lawsuits on NH taxpayers’ dime,” she posted. “Thanks, NHGOP.”

The legislation overturns the state’s affidavit system, which allows people who show up at the polls without identification to vote. This system will still be in place for this election, but critics of the bill say it will disenfranchise voters in the future.

In a statement, McKenzie Taylor, the campaign director for the New Hampshire Campaign for Voting Rights, said the law now makes the Granite State the first in the country to require voters show proof of citizenship to cast a ballot.

“This extreme legislation signed by the Governor will roll back voting access for all eligible Granite Staters,” Taylor said. “Once this law goes into effect later this year, any voter may be turned away from the polls if they did not have the correct documents, creating massive new changes to New Hampshire’s registration system, burdening our election officials, and disenfranchising eligible voters.”

https://thehill.com/homenews/state-watch/4877611-new-hampshire-voter-id-laws-future-elections/

2 Springfield OH schools evacuated, another closed for the day

 The Springfield City School District in Ohio closed one middle school and evacuated two elementary schools Friday.

Elementary school students were evacuated from their buildings and moved to a different location after receiving direction from the Springfield Police Division. Students are being released to their parents, the Springfield News-Sun reported.

Roosevelt Middle School was closed before the school day began in relation to information the school district received from law enforcement, the outlet said.

It’s not clear if the school evacuations were linked to a bomb threat Thursday against the Springfield City Hall, but explosive-detecting K-9 helped police clear areas Thursday, Springfield Police Chief Allison Elliott said, according to ABC News.

On Thursday, City Hall was evacuated after a bomb threat was issued to “multiple facilities” in the area. Two elementary schools were also listed in the threat.

It was later revealed the bomb threat used hateful language against the city’s immigrant population.

Ohio Gov. Mike DeWine (R) and Springfield Mayor Rob Rue, as well as other local authorities, have brushed off negative remarks.

DeWine said the internet can be “quite crazy sometimes.” He said migrants are choosing Springfield because of its job opportunities and said employers say they have “done a very, very good job, and they work very, very hard.”

Rue said claims created a “negative light” for the city. He admitted that Springfield is experiencing an “infrastructure strain” due to the increased immigration population and is seeing a “culture clash” as the false narratives about migrants continue to spread within communities..  

DeWine announced Thursday that the state would send health care and public safety support to Clark County, which houses Springfield. He criticized the lack of federal help but said Ohio will “not walk away” from the migrant influx in the area and the needs of the community.

https://thehill.com/homenews/state-watch/4878462-springfield-bomb-threat-schools-closed-eating-pets-trump-vance/

Is China teaching your child in public school?

 Public displays of antisemitism on college campus over the last year have focused attention on foreign entities funding American higher education. But less publicized — and more insidious — are foreign influences in K-12 schools.

Many young adults are arriving on their college campuses already radicalized. Much of that is due to the subtle, hostile influences that they’re exposed to in grade school. Congress must address this critical problem for the sake of the next generation.

In September 2023, the House Committee on Education and the Workforce held a hearing about how the Chinese Communist Party was influencing the American education system in public and private K-12 schools. Ryan Walters, Oklahoma’s superintendent of public instruction at the time, told lawmakers that the “Confucius Classrooms” program was a national security threat, and that Congress should “pass a law to ban schools from accepting money from hostile foreign governments.”

Walters was absolutely correct. China is an expert at using “soft power” to exert its influence around the world. Rather than march an army into enemy territory or fund terrorist groups, China uses industry, infrastructure and education to undermine its competitors.

Whether through funding infrastructure in third-world countries, manufacturing necessary goods such as medical supplies, or providing loans to nations who ask, China understands how to wield influence. Any instance of its government funding an initiative in another country should be viewed with suspicion.

The college-level version of the Confucius Classrooms program, Confucius Institutes, has come under intense scrutiny by legislators on both sides of the aisle over the past decade. These institutes are glorified Chinese propaganda arms that, at their peak, operated on nearly 100 American college campuses, including Columbia and Stanford. They are funded and staffed almost exclusively by an agency of Chinese government’s Ministry of Education. While the public and legislative attention caused many of these institutes to shut down, the K-12 version of the program, Confucius Classrooms, has continued to grow.

While the total number is unknown, the National Association of Scholars released a report earlier this year documenting at least 164 Confucius Classrooms programs across the U.S., 79 percent in public school districts.

The Confucius Classrooms programs primarily teach Chinese language to students, but often they also include courses in history or economics. That may sound benign, but each Confucius Classrooms teacher is hired and approved by the Chinese Communist Party and is expected to promote China and socialism to students. These classes are a subtle way for the Chinese government to influence young Americans and make them more sympathetic to socialist ideology and China’s global aims.

Children should not be taught a history that excludes Tiananmen Square or includes economics based on communist theories.

To hide the appearance of direct financial ties to China, these programs are funded and sustained through nonprofit entities, which in turn receive their funds from China. The group Parents Defending Education released a report last year detailing some of the funding streams from China-backed organizations into American public schools.

An example from the report is Thomas Jefferson High School for Science and Technology, a public magnet school in Virginia, which “received more than $1 million in financial aid from Chinese government-affiliated entities over the course of a decade.” A similar scheme is repeated in every school where a Confucius Classrooms is located.

While many of these nonprofits are relatively obscure, some are not, such as the College Board. Best known as the organization behind the SATs and AP courses, the College Board has greater access to the public education system than almost any other nonprofit in the country. Its ties to China date back to 2003, when it began working with the Chinese Communist Party to build Mandarin language programs in the U.S. The College Board is responsible for planting at least 20 Confucius Classrooms programs, in addition to the AP Chinese course that it created in collaboration with the Chinese government.

To combat foreign influence in K-12 education, especially from hostile countries like China, there are a couple of legislative fixes Congress can pursue.

One solution is revitalizing the 1938 Foreign Agent Registration Act, which requires the disclosures and registration of anyone with relationships to foreign governments. Unfortunately, this law has broad exemptions from its disclosure requirement for “religious, scholastic, academic, fine arts, or scientific pursuits,” and China’s interests in the education sector clearly fall into those categories. By amending the Foreign Agent Registration Act to remove some of those exemptions, Congress would force nonprofits and individuals connected to China or other hostile actors to be transparent about those ties.

While that would help cut off the funding stream, Rep. Aaron Bean (R-Fla.) and Sen. Ted Cruz (R-Texas) introduced a far simpler short-term solution: the TRACE Act. This bill would give parents the right to know about any curriculum with ties to another country. If passed, parents would have the ability to review classroom and professional development materials funded by foreign governments and foreign entities of concern. If those materials are going to be in the classroom, parents have a right to know where they originated.

The American education system has plenty of problems without the outside influence of hostile nations. Yet countries like China are using our K-12 schools as just one more way to influence American society. A foreign-linked curriculum designed to teach the next generation to appreciate socialism and to empathize with America’s greatest competitor is a national security threat, and Congress has a responsibility to address it.

Maggie McKneely is legislative strategist for Concerned Women for America, the nation’s largest public policy women’s organization.

https://thehill.com/opinion/education/4877457-is-china-teaching-your-child-in-public-school/

Regulators will need to closely watch new frontier of DTC drugs

 More than a quarter of a century ago, the FDA eased regulations

opens in a new tab or window to make it easier for pharmaceutical companies to advertise directly to consumers. Today, it is nearly impossible to get through a family sitcom without hearing an ad listing symptoms and side-effects and encouraging the viewer to "speak with" their physician.

If patients and physicians are tired of the drug company pleas, tighten your seat belts.

Two major pharmaceutical companiesopens in a new tab or window have announcedopens in a new tab or window they intend to sell directly to consumers using digital health platforms. Other companies will likely follow suit. It appears major pharmaceutical companies are trying to keep up with successful smaller platforms like Hims & Hers.

Will this trend benefit consumers? I'm skeptical.

The New Frontier: Digital Health and Direct-to-Consumer Medication

If you have watched any PG-13+ streaming service with your teen or significant other, you have probably heard of Hims & Hers. From hair loss to erectile dysfunction, this company advertises directly to consumers and then uses digital platforms to connect patients with healthcare providers who can diagnose symptoms and prescribe medications without ever having met the patient in person. In May, the company announcedopens in a new tab or window its first quarter revenue increased 46% year over year and was about $10 million higher than Wall Street analysts had predicted.

Why is Hims & Hers so successful? In part, because the company is focusing on challenges like hair loss and erectile dysfunction -- issues that most patients would rather not discuss with anyone in person, even a trusted physician.

Given the skyrocketing demand for GLP-1 weight loss drugs, online direct-to-consumer providers with pharmacy relationships are now trying to get a piece of that market too. Specifically, online providersopens in a new tab or window have been prescribing, and pharmacies with relationships to these providers have been compounding these drugsopens in a new tab or window and offering them at a lower price than legacy manufacturers.

Are you starting to get a sense of why pharmaceutical companies are ready to take the leap beyond direct-to-consumer marketing into direct-to-consumer sales? Faced with these new market entrants and competition, pharmaceutical giants are hungry to reclaim their territory.

The Drivers Behind Pharma's Pricing Strategies

To fully understand why pharmaceutical companies are making this move, it is important to consider the drivers behind pharmaceutical pricing strategies.

Pharmaceutical companies often justify high prices by pointing to the substantial investments required to bring a new drug to market. For example, the Pharmaceutical Research and Manufacturers of America (PhRMAopens in a new tab or window), the drug companies' chief lobbying organization, has argued that over the last decade, its member companies "have more than doubled their annual investment in the search for new treatments and cures."

While there is no doubt these investments are valuable, companies largely set prices without market pressure because of a lack of competition driven by exclusivities and maneuvering around patent law. As a forthcoming paper from the University of North Carolina's Center for the Business of Healthopens in a new tab or window explains, marketing expenses (including direct-to-consumer advertising) add to the high drug prices passed on to consumers, as do complex supply chain dynamics, involvement of pharmacy benefit managers (PBMs), and charity prescription programs.

The paper also illustrates that drug prices are higher in the U.S. than they are in other countries because a large and complex network of players -- from insurers to regulators to drug companies themselves -- all try to influence the process. Direct-to-consumer models eliminate at least some of the players in this ecosystem. They also respond to a social demand: consumers and members of Congress are fed up with high drug prices. Indeed, 80% of Americansopens in a new tab or window think the prices of drugs in the U.S. are unreasonable.

Drug giants are responding to that sentiment. But will direct-to-consumer sales actually help patients save money?

The Business Strategy Behind the Direct-to-Consumer Play

Major pharmaceutical companies have argued their new direct-to-consumer offerings will improve price transparency for patients, reduce costs by eliminating the need for much-vilified middlemen like PBMs, and improve access to life-improving medications.

On the surface, this appears to be a major win for patients. But of course, there is more to the story. In fact, this development may come down to just one type of drug: GLP-1s.

A 2023 JP Morgan analysisopens in a new tab or window estimated the GLP-1 market would exceed $100 billion by 2030. About 10% of type 2 diabetes patients used a GLP-1 last year, the report noted, but that number could top 35% within the next 6 years. Overall, total U.S. GLP-1 users might top 30 million by 2030, about 9% of the nation's population.

As compounding pharmaciesopens in a new tab or window and digital health companies have begun offering lower-cost alternativesopens in a new tab or window to high-priced GLP-1s, the demand for the original, more expensive medications has declined. By going direct-to-consumer, drug companies can bypass traditional distribution channels, maintain tighter control over pricing, and prevent patients from switching to lower-cost alternatives. In essence, they can create a new revenue stream that allows them to retain as much market share as possible, even as competition heats up.

For pharmaceutical manufacturers, it is almost always about protecting their bottom line.

Lower Prices, but Will Patients Become Prey?

Lower drug prices are undeniably good for patients. Most importantly, reducing costs improves adherence to a medication regimen. Anything that reduces the financial burden on patients and increases access to necessary medications should be seen as a positive development. The key word in that sentence, however, is "necessary."

The advent of direct-to-consumer marketing has not been good for patients. According to a studyopens in a new tab or window released last year by researchers at Johns Hopkins University (JHU), it has increased pressure on clinicians to prescribe drugs that may not actually be the best option for patients. Perhaps the most startling of JHU's findings is this one: drug companies spent nearly 15% more on direct-to-consumer advertising for treatments that demonstrated a lower added benefit to patients. It appears drug companies are most aggressive the closer they get to consumers.

By moving to a direct-to-consumer model, some pharmaceutical companies may be at risk of "pushing" drugs on patients who may not need them, or who would be better off with some other treatment, including one that did not involve pharmaceuticals at all. If not carefully monitored, the digital health platforms that make it easier for patients to obtain medications could lead to overprescribing.

The trend of pharmaceutical companies entering the direct-to-consumer space represents a significant shift. While there could be upsides, including lower drug prices and increased access, it also raises important questions about these companies' motives. As this trend continues to develop, it will be crucial for regulators and healthcare providers to ensure these new models are used responsibly.

N. Adam Brown is a practicing emergency physician, entrepreneur, and healthcare executive. He is the founder of ABIG Health, a healthcare growth strategy firm, and a professor at the University of North Carolina's Kenan-Flagler Business School

Disclosures

Brown serves as co-chair of the University of North Carolina's Center for the Business of Health board, and as a professor of practice at UNC-Chapel Hill Kenan-Flagler Business School.

https://www.medpagetoday.com/opinion/prescriptionsforabrokensystem/111937