AstraZeneca expected to miss EU Covid vaccine supply target by half in second-quarter – report

Expected shortfall of 90m doses could hit the EU’s ability to meet its target of vaccinating 70% of adults by summer

AstraZeneca has told the European Union it expects to deliver less than half the Covid-19 vaccines it was contracted to supply in the second quarter, an EU official told Reuters on Tuesday.

Contacted by Reuters, AstraZeneca did not deny what the official said, but a statement late in the day said the company was striving to increase productivity to deliver the promised 180m doses.

Related: Scepticism over Oxford vaccine threatens Europe’s immunisation push

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Sussex medicines firm takes production line abroad in white van to beat Brexit ban

UK assembly line at standstill as pharmaceutical company sets up in Amsterdam and plans EU expansion

A Sussex pharmaceutical company has told how it had to bundle a production line into a white van and take it to Amsterdam to beat a Brexit medicines ban.

The impromptu four-wheeled mission to the Netherlands has secured the supply of the asthma drug Ventolin for France, where the company, Mediwin, had a huge order book.

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German politicians counter AstraZeneca vaccine scepticism with show of support

Oxford Covid vaccine described in German media as ‘shelf warmer’ with only 17% of doses administered so far

Politicians in Germany are stepping out in support of the AstraZeneca vaccine as public scepticism around the Oxford-developed product is threatening to hamper Europe’s Covid-19 immunisation programme.

The vaccine, subject of an acrimonious tug-of-war between its British-Swedish manufacturer and the European commission last month, is now being described by German media as a “shelf warmer” as only around 17% of doses delivered to the country have been administered so far.

Related: A quarter of people in France, Germany and the US may refuse Covid vaccine

Related: AstraZeneca to build new Covid-19 vaccine facility in Germany

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Solidarity Is Not an Easy Sell as E.U. Lags in Vaccine Race

Europe’s collective vaccine purchase is an experiment in deeper integration. Despite a rocky start, many countries still stand to benefit, but it’s the most powerful who have least to gain.

Solidarity Is Not an Easy Sell as E.U. Lags in Vaccine Race

Europe’s collective vaccine purchase is an experiment in deeper integration. Despite a rocky start, many countries still stand to benefit, but it’s the most powerful who have least to gain.

Solidarity Is Not an Easy Sell as E.U. Lags in Vaccine Race

Europe’s collective vaccine purchase is an experiment in deeper integration. Despite a rocky start, many countries still stand to benefit, but it’s the most powerful who have least to gain.

France and Germany threaten AstraZeneca over vaccine shortage

Warning of ‘legal commitment’ and concern that doses might have been diverted from the EU to the UK

France and Germany have threatened legal action against the Anglo-Swedish pharmaceutical company AstraZeneca in the row over a shortage of coronavirus vaccine in the EU.

Talks between the European commission and the vaccine supplier are continuing over the lack of supply, with Brussels raising concerns that doses may have been diverted from plants in Belgium and Germany to the UK.

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EU Covid incompetence leaves governments wanting vaccines, not excuses | Larry Elliott

Centralised approach was meant to underline Europe’s solidarity but has had opposite effect

The EU has made an almighty hash of procuring treatments for Covid-19. Vaccine centres are running short of supplies as a result. National governments want jabs rather than excuses for what has gone wrong. The search for scapegoats is on.

Stripped of the legal wrangling between Brussels and AstraZeneca, the protectionist plan to ban exports of drugs and the now-abandoned plan to close the border between Northern Ireland and the Republic, the EU has been incompetent – and no amount of bully-boy tactics can get away from that fact.

Related: How EU’s floundering vaccine effort hit a fresh crisis with exports row

But what really mattered was not price but speed and breadth of supply

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How EU’s floundering vaccine effort hit a fresh crisis with exports row

A new rule on exports from Europe suddenly blew up into a threat to the withdrawal agreement – and a hasty backtrack

It started with a tweet by a blogger at 4.36pm on Friday. It ended with the prime ministers of the UK and Ireland warning the European commission president, Ursula von der Leyen, during late night calls, that she had put peace at risk by effectively seeking to erect a vaccine border between Northern Ireland and the Republic.

“OK, I’m not usually on here any more, but I’m making an exception because this is very interesting: the EU’s regulation on export controls for vaccines *does* include vaccines going to Northern Ireland, and the EU is invoking Article 16 of the Ireland/Northern Ireland Protocol,” @dijdowell had tweeted. “I really didn’t have Article 16 being used *by the EU* in the first month of the Protocol’s operation on my list of predictions for 2021. I would be fascinated – *fascinated* – to know what the Irish Government makes of setting this precedent.”

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EU to publish revised rules after Covid vaccine border fiasco

Commission plans to rush through regulations that ‘ensure Northern Ireland protocol remains unaffected’

Brussels will publish a revised regulation to potentially block vaccine exports out of the EU on Saturday, after an international outcry over its initial plans to erect an export border for doses on the island of Ireland.

The European commission’s newly drafted implementing regulation is expected to be both unveiled and come into force on Saturday with officials insisting they would now “ensure that the Ireland-Northern Ireland protocol is unaffected”.

Related: Arlene Foster urges Boris Johnson to replace NI protocol

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What can moral philosophy tell us about the Covid ‘vaccine nationalism’ row? | Alexis Papazoglou

The shortfall in supply has put the EU and the UK at loggerheads, but ethical principles could reveal a solution

In normal times, a row between the EU, the UK and a private company over the timely delivery of a contract would be of interest to few apart from the two sides’ lawyers. But these are not normal times, and this is no ordinary contract.

The battle over the Oxford/AstraZeneca vaccine raises deeper ethical questions about who deserves priority access to a life-saving drug. It’s a discussion many countries have already had in a domestic context, where a consensus hasn’t been hard to reach: priority should be given to those who are most likely to catch or die of Covid-19, and therefore stand to benefit the most from a jab. But who should be prioritised for vaccination in the global context?

Alexis Papazoglou is host of the podcast The Philosopher & The News. He has a PhD in philosophy from the University of Cambridge and writes on the intersection between philosophy, politics and current affairs

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EU could block millions of Covid vaccine doses from entering UK

European commission says new mechanism will give national regulators power to refuse exports

Millions of doses of vaccines could be blocked from entering Britain from the EU within days, as part of Brussels’ response to a shortage of doses among its member states.

The European commission said a new authorisation mechanism would be established to give national regulators the power to refuse vaccine exports. The development will raise concerns over the continued flow of the Pfizer/BioNTech vaccine, for which the UK has a 40m-dose order.

Related: Coronavirus live news: Germany blocks use of AstraZeneca vaccine in over-65s; Portugal says situation is ‘terrible’

Related: Germany recommends Oxford Covid vaccine not be used on over-65s

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Patients as Partners Europe: Are we doing patient centricity all wrong?

To be truly patient centric, do we need to turn the current model on its head and work within a more free-thinking, free-speaking framework? Amanda Barrell reports from Patients as Partners Europe.

Despite huge progress over the last decade, patient involvement in research is still largely in the hands of the pharmaceutical companies.

That is according to neuroscientist-turned-advocate, Dr Jonathan Stamford, who told this week’s virtual Patients as Partners Europe conference that patients – not industry – should be driving the charge.

“The evolution of the patient involvement is a relatively explosive field. If you go back ten years, the role of patients in research was fundamentally as subjects. There were recruited and followed up but that was the limit of their involvement,” he said.

“Now, they are increasingly finding themselves participants in trial design.”

However, the current models of engagement were not leveraging the best insights from patients, he said.

“Moving away from structured, formulaic consultation and simply listening to what people have to say would lead to much deeper, more valuable insights.”“While it varies from company to company, it is still very much at the drug company’s bidding in terms of their interpretation of the requirements,” he said.

“The company will have a series of questions they want answered, but to my mind the biggest thing we need to do is encourage a sense of co-responsibility. That means more dialogue, more involvement, and more depth.”

Building co-responsibility

Dr Stamford brings something of a unique perspective to his advocacy work. He led a small group of Parkinson’s disease (PD) researchers for years before being diagnosed with the condition himself in 2006, three years after retiring from academia.

Since then, he has dedicated himself to patient advocacy, with The Cure Parkinson’s Trust, and as co-founder of Parkinson’s Movement, which aims to give the collective PD community a voice in research.

He also acts as an independent advocate, with current projects including a series of videos that explore the taboo elements of PD. Dr Stamford is also part of a consultancy panel, currently mothballed because of COVID-19, of scientists and healthcare professionals who live with the condition themselves.

Expanding on his idea of co-responsibility, Dr Stamford said it was a case of “building foundations” upon mutual interests.

The pharma industry and patients are co-dependent, and they occupy the same space, despite the traditional silos that have built up over the years.

Understanding that patient-to-patient conversations are often very different to patient-to-HCP or patient-to-researcher conversations is crucial to progress, said Dr Stamford.

“For example, a lot of the side effects of PD medications are much more well known to the patients than they are to the drug companies,” he said.

Moving away from structured, formulaic consultation and simply listening to what people have to say would lead to much deeper, more valuable insights.

“We need a basis not of patients talking to drug companies, but patients talking among themselves and drug companies capturing that information,” he said.

“I think that is where significant advances can be made, through these much more frank, honest discussions.”

Taking control

Achieving true patient centricity would involve turning the current model on its head, Dr Stamford believes.

“Often, an advisory board will be a drug company presenting what they are doing, and almost seeking approval from the patients.”

It is an approach that can “trivialise the knowledge and expertise” of the participants, and one that can make it very difficult to uncover what really matters to patients.

“I think it should be the opposite way round. Patients should be driving the agenda. In an ideal world, patients would be setting up their own advisory boards, and inviting drug company representatives to hear what they have to say.

“I think that is where the greatest progress will be made, and that’s the area with the most significant deficit.”

Expanding on limited scope

Asked how things could be improved, Dr Stamford said the biggest problem currently was that patient advocacy was “very limited in scope”.

“When you ask those of us who are patient advocates what our advocacy entails, for the most part it is a case of increasing awareness among the lay population,” he said.

“But I think that is setting the bar too low. Advocacy needs to be more proactive.”

Some patient communities, he said, had a culture of passivity that runs counter to effective, collaborative working.

“That is something we have to resist. Because, to my mind, the scope of what patients can achieve is colossal. It just requires vision,” he said.

He believes that educating patients on what can be achieved with advocacy is the key to taking the movement to the next step.

Tapping into success stories and learning how proactive patient communities, such as those in HIV and AIDS, operate, could help to expand the scope of advocacy – and empower people to take control.

About the author

Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.

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GameStop’s dizzying share price rise means it’s game over for the short-sellers | Nils Pratley

The retailer has gone from $19 to $33o thanks in part to amateurs taking on the hedge funds

If you find trading bitcoin insufficiently hair-raising, try GameStop. It is the Texas-based video games retailer that will be hard to out-do as the stock market story of 2021. The share price was $19 at the start of this month but reached $330 in mid-afternoon on Wednesday in New York. There have been a few downwards lurches along the way, but the overall direction has been unsustainably upwards.

It must be unsustainable because nothing of note has happened to improve GameStop’s commercial prospects so radically. Exciting Playstation and X-Box releases may lie around the corner, but the company is still a bricks-and-mortar retailer struggling in an online age. Instead, punting on GameStop has become a video game in itself.

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The EU’s vaccine bust-up with AstraZeneca is of its own making | Leo Cendrowicz

Slowness to sign up to and approve the vaccine may have caused delays, but Brussels feels the company is being less than cooperative

Last year AstraZeneca was heralded for its pioneering vaccine discovery. Yet today the British-Swedish pharmaceutical company is embroiled in a dispute with the European Union over claims that it is holding back vaccine deliveries for the bloc, while diverting supplies to Britain and other countries. But can AstraZeneca be blamed for the EU’s stuttering vaccine rollout, which is far behind Britain, the US and other countries?

Anger is certainly surging across the EU about the slow pace of vaccinations. The latest figures from Our World in Data reveal that just 2.1% of the EU population has received a vaccine, compared with 10.8% for the UK. The goal to vaccinate at least 70% of the EU’s population by this summer is wildly off – at the current pace, the bloc as a whole would reach only 15% by the end of September.

Related: Why has the EU been so slow to roll out a Covid vaccination programme? | Guntram Wolff

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AstraZeneca denies pulling out of talks as EU Covid vaccine row deepens

Latest round of crunch talks to discuss breakdown in supplies still happening, says spokesman

A row over coronavirus vaccine shortages in the EU has descended into farce as AstraZeneca denied claims by the European commission that it had pulled out of a crunch meeting over a breakdown in supplies.

Within minutes of a spokeswoman for the commission announcing that the Anglo-Swedish pharmaceutical company was refusing to attend, the claim was rebutted in a short statement. “We can confirm we have not pulled out and will be attending talks with the EU commission later today,” a spokesman for AstraZeneca said.

Related: EU’s vaccine supply issues mean light at end of tunnel that much further away

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Head of AstraZeneca rejects calls for UK vaccine to be diverted to EU

Chief executive of pharmaceutical giant says the firm will honour UK’s earlier contract despite EU anger over shortfall

AstraZeneca’s chief executive has insisted the UK will come first for vaccines as he rejected calls to divert doses to the European Union following a breakdown in supply.

Amid a growing row, Pascal Soriot, the French head of the pharmaceutical giant, said the UK was benefiting from being early to sign a contract for 100m doses.

Related: EU threat will not impact Covid vaccine deliveries to UK, says minister

Europe invested billions to help develop the world’s first Covid-19 vaccines. And now, the companies must deliver

With the UK we’ve had three extra months to fix all the glitches. For Europe, we are three months behind

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EU means business over Covid vaccine exports, says Von der Leyen

Commission president says firms must deliver on orders after AstraZeneca warns of shortfall

The EU “means business”, Ursula von der Leyen has said, as the bloc doubled down on plans for tighter monitoring of vaccine exports to countries outside of the union, such as the UK.

Speaking at the World Economic Forum, the president of the European commission said the EU had invested billions and “companies must now deliver” to the 27 member states.

Related: EU threatens to block Covid vaccine exports amid AstraZeneca shortfall

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German government challenges AstraZeneca Covid vaccine efficacy reports

Newspaper had reported that government was expecting European regulator’s assessment to show that vaccine was only 8% effective among over-65

The German government has challenged reports of a lower-than-expected efficacy rate of the AstraZeneca vaccine for older people, while reiterating concerns about the British-Swedish pharmaceutical giant’s data reporting.

An article in German business daily Handelsblatt had reported that the German government was expecting the European Medical Agency’s (EMA) assessment to show the AstraZeneca vaccine to be only 8% effective among the over-65s, describing it a “setback for Berlin’s vaccination strategy”.

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Germany to administer Covid drugs used to treat Donald Trump

Country will be first in EU to use antibody cocktails after government buys 200,000 doses

Specialist clinics in Germany will this week become the first hospitals in the EU to treat Covid-19 patients with expensive and experimental antibody cocktails used to treat the former US president Donald Trump after he caught the virus last October.

“Monoclonal antibodies will be used in Germany as the first country in the EU, initially in university clinics,” the health minister, Jens Spahn, told Bild am Sonntag newspaper, confirming that his government had bought 200,000 doses for €400m (£355m).

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EU’s Covid vaccination debacle is down to institutional inflexibility

Supply delays underline there was no legal or economic justification for central planning

A storm is raging over the EU’s failure to have ordered more of the approved Covid-19 vaccines ahead of time. Stéphane Bancel, the CEO of the US pharmaceutical company Moderna, which gained approval for its vaccine shortly after Pfizer/BioNTech, claims that the EU has relied too much on “vaccines from its own laboratories”.

Did the European commission prioritise supporting its own pharmaceutical industry over protecting human lives? In fact, matters are not as simple as that. Contrary to what Bancel wants us to believe, the EU has actually ordered too little of its own vaccine. After all, the vaccine that is being administered most widely across the west was developed by a German company, BioNTech, and thus comes from the EU (though it was tested and partly produced in partnership with Pfizer in the US and with Fosun Pharma in China).

Related: The $2,000 stimulus cheques alone won’t work – the US needs better infrastructure

EU member states were wrong to entrust the European commission with the purchase of vaccines last summer

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EU plans video summit after doubling supply of Pfizer Covid vaccine

Bloc agrees deal for a further 300m doses as hopes are raised for speedier rate of inoculations

EU leaders are to hold a pandemic video summit on 21 January after the bloc said it had reached a deal with Pfizer and BioNTech for 300m more doses of their Covid-19 vaccine, giving the EU nearly half the firms’ global output for 2021.

The move raised hopes for speedier inoculation across the continent as the European regulator, which this week approved the Moderna shot, said it would authorise six doses from each vial of the BioNTech/Pfizer vaccine, increasing available jabs by 20%.

The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.

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Why cell therapy manufacture is a team sport

Louis van de Wiel, Vice President, Site Head EU Manufacturing, Kite, a Gilead Company, reveals the complexity that sits behind the process of individualised cell therapy – and why team culture makes it work

This thought leadership series has been paid and developed by Kite, a Gilead Company.

In 2018, we were preparing to build a European facility to produce individualised cell therapies for the treatment of cancer.

Roll on two years and the team has achieved what at the time appeared a major challenge, putting 1,000 tonnes of steel, 1,800 solar panels and 176km of network cable into the creation of a centre of excellence for cell therapy near Amsterdam in the Netherlands.

In my experience, completing the design and build of a facility such as this, through to qualification, licence and becoming fully operational, would normally take four to five years. Our ambition was always to do this within two years, a goal we achieved despite the unprecedented challenge of a global coronavirus pandemic.

Indeed, while undoubtedly putting new hurdles in our path, the arrival of COVID-19 into our lives has transformed our business and operations by presenting an opportunity to be adaptable, flexible and responsive – and to continually evaluate and mitigate risk.

“There is huge complexity involved in cell therapy manufacture, with hundreds of personnel responsible for ensuring the quality and supply of an individual patient’s cells”

It’s been a complex process that’s required highly technical and skilled personnel. Not only did we build a specialised facility from the ground up, but we built an organisation, from 10-15 people two years ago to more than 400 now. We put energy and emphasis into creating the right team and a culture where everyone understands the values and drivers, allowing us to operate in a collaborative and cohesive way.

Now the new €130 million, 19,000m2 manufacturing facility near Amsterdam is able to support delivery of up to 4,000 cell therapies each year for eligible cancer patients across Europe.

But backtrack to August 2018 and the very first European patients were also receiving treatment, part of an expertly crafted operation that ran in parallel to the build. Our supply chain group worked with the existing US team to manage the shipment of patients’ cells to the US for modification and their return for treatment.

Having a fully operational site in Europe versus the US has several advantages; reducing transportation time, strengthening the chain of custody and, potentially, cutting lead time to the patient by approximately one week. This allows us to potentially provide the therapy quicker for eligible cancer patients who have stopped responding to or have progressed despite other treatments. At this stage of their disease, for patients who have no other options, a week can make a difference.

The journey of the cell

The very nature of cell therapy manufacture means employees work in tightly controlled environments to ensure adherence to good manufacturing practice standards and, ultimately, to ensure the quality and integrity of the product.

Ultimately, it’s a team sport between Kite and Gilead and the 100-plus qualifying hospitals across Europe, all of which have been individually trained and assessed to ensure they are fully compliant with the necessary procedures and meet exacting standards.

So, what does the journey of the cell look like?

To achieve consistent, timely delivery of a high-quality product requires a robust and efficient approach to engineering patient’s own T cells, which in itself encompasses apheresis, cell modification and final formulation – coupled with rigorous quality control testing throughout – reflecting the highly complex nature of the manufacturing process.

Understandably, teamwork is vital and requires an integrated network and seamless communication between Kite and the treating hospital. The journey starts with the hospital making a treatment reservation through KiteKonnect and shipping of the apheresis kit to enable the process of extracting the patient’s own white blood cells, kickstarting both the chain of identity and chain of custody.

Here, our quality and supply chain experts are integral to every stage of the cell therapy manufacturing continuum to ensure the product is returned to the patient in a timely manner.

As soon as apheresis has completed, the cells are shipped in temperature-controlled conditions to our facility near Amsterdam where they are assessed for quality and condition. One patient equals one individual treatment, so it is critical to preserve the chain of custody and chain of identity to ensure the product comes back to the same patient.

Why chain of custody and identity is critical

The chain of custody and chain of identity must, therefore, go hand-in-hand. In this way, not only do we know which cells belong to which patient, but we have precise location and up-to-the-minute feedback on storage conditions to ensure quality and safety is paramount at all times.

Once the cells have completed this first stage, the manufacturing process can begin, with T cell selection, activation, and genetic modification using viral vector technology to ensure the ability to recognise the patient’s cancer cells. Cell expansion follows to multiply the modified cells into their millions.

Further critical quality testing then takes place to ensure the cells are of a required standard and to create a finished purified product, which will be stored and returned to the originator hospital in temperature-controlled conditions (see diagram below).

Several quality attributes will be tested at this stage and the cells must meet these rigorous criteria and specifications. There is huge complexity involved in cell therapy manufacturing, with hundreds of personnel responsible for ensuring the quality and supply of an individual patient’s cells.

As part of this process, the supply chain team simultaneously coordinate with the hospital to prepare the individual so when the cells are infused back to the patient they are primed to potentially fight the cancer.

Individualising the approach

In stark contrast to basic biopharmaceutical products with a robust starting material, the cells of a patient with cancer who has already undergone multiple treatments will not have the same quality. Consequently, there can be unforeseen hurdles during the process and I am proud that the team has managed each situation to safeguard the patient’s cells and ensure they receive treatment in an efficient and timely way.

This is particularly important when you consider the turnaround for each individualised product from starting material to the patient is typically four weeks – versus months or even years for a standard biopharmaceutical product.

Additionally, each patient equals one product batch – we do not keep inventory – and the potential impact on the patient if something happens to that batch is why we are so passionate. From quality manufacturing, facility engineering, supply chain, we’re driven to make sure the batch is returned to the patient safely and effectively.

What of the future? For me, it’s all about leadership, clarity, direction, and commitment of the entire team. It’s about the opportunity to be involved in an innovative field of cancer therapy where the body is stimulated to fight cancer cells. It’s about optimising the manufacturing process to become more effective and efficient. But, most of all, it’s about the patients, their care partners and families

 

This was supported by Kite, a Gilead Company
UK-CTH-2020-11-0075 | Date of preparation: December 2020

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BioNTech criticises EU failure to order enough Covid vaccine

Firm races to fill potential gap left by bloc’s gamble on several vaccines being approved

BioNtech has criticised the EU’s failure to order more doses of its coronavirus vaccine, saying it is now racing with its US partner Pfizer to boost production amid fears of a European “gap” left by the lack of other approved vaccines.

The Pfizer/BioNTech vaccine was the first to be approved by the bloc late last month, after being accepted by the UK, Canada and the US. They and other countries have also since approved the Moderna or Oxford/AstraZeneca vaccine, leaving the EU trailing behind.

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Sector by sector: are British firms ready for post-Brexit trade?

Analysis: From retail to aviation to pharmaceuticals, we look at what will change from 1 January

After months of tortuous negotiations between the UK and the EU, a Brexit trade deal was agreed at almost the last minute. But how prepared are UK businesses for the significant changes that will come into force on 1 January? Are they happy with the terms of the agreement?

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‘I’ve never seen anything like it’: 2020 smashes records in global markets

From worst crash in a generation to record highs on news of a Covid vaccine, experts review the rollercoaster that was 2020

2020 has been the most remarkable year for the global financial markets. After the Covid-19 pandemic triggered the worst crash in a generation, unprecedented stimulus measures and vaccine breakthroughs have sent stocks roaring back to record highs.

In a year in which at least 1.7 million people died from coronavirus and unemployment soared in a global recession, world stock markets are ending 2020 up 13% – despite the latest surge in cases forcing further lockdowns this winter.

GUARDIAN: Stock markets in biggest fall since 2008 #TomorrowsPapersToday pic.twitter.com/1FX7ivVZZT

Related: As Airbnb’s shares go through the roof, we need to challenge the Big Tech monopoly | Will Hutton

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Arsenic in Infant Rice Cereal

When it comes to rice and rice-based products, pediatric nutrition authorities have recommended that arsenic intake should be as low as possible.

“The US Food and Drug Administration (FDA) has been monitoring the arsenic content in foods” for decades, yet despite the “well-established science describing the health risks associated with arsenic exposure, no standards have been set limiting the amount of arsenic allowable in foods” in the United States. In 2001, the EPA “adopted a new stricter standard for arsenic in drinking water,” and in 2013, the FDA proposed a legal limit for apple juice. “There are still no standards for arsenic in food products despite the fact that food sources are our main source of exposure.”

Unlike the United States, China has standards. As of 2014, China set a maximum threshold of inorganic arsenic at 150 parts per billion, stricter than the World Health Organization’s limit of 200 ppb. In the United States, a 200 ppb limit wouldn’t change the cancer risk much. If we had China’s safety limits of 150 ppb, though, cancer risk would be reduced up to 23 percent and a maximum threshold of 100 ppb would lower cancer risk up to 47 percent—but that could seriously affect the rice industry. In other words, U.S. rice is so contaminated with arsenic that if a safety standard that really cut down on cancer risk were set, it “would wipe out the U.S. rice market.” However, with no limits, what’s the incentive for the rice industry to change its practices? Setting arsenic limits would not only directly protect consumers but also encourage the industry to stop planting rice paddies on arsenic-contaminated land.

Those cancer estimates are based on arsenic-contaminated water studies. Might the arsenic in rice somehow have a different effect? You don’t know…until you put it to the test. We know rice has a lot of toxic arsenic that urine studies have shown we absorb into our body, but there hadn’t been any studies demonstrating “deleterious health impacts” specific to rice arsenic—until now. Since arsenic causes bladder cancer, the researchers figured they would see what kind of DNA mutations the urine of rice eaters can have on human bladder cells growing in a petri dish. And, indeed, they clearly demonstrated that eating a lot of arsenic-contaminated rice every day can “give rise to significant amounts of genetic damage,” the kind that‘s associated with cancer. Yes, but the study used pretty contaminated rice. However, only about 10 percent of the rice in certain parts of Asia might ever reach those levels of contamination, though a quarter of rice in parts of Europe might and more half in the United States, making for considerable public health implications.

So, “there remains little mystery surrounding the health risks associated with arsenic levels in rice. The remaining mystery is why long-overdue standards for arsenic levels in rice have not been set by the FDA” in the United States, but that may be changing. In 2016, the FDA proposed setting a limit on toxic arsenic—at least in infant rice cereal, which I discuss in my video Arsenic in Infant Rice Cereal.

As you can see at 3:24 in my video, infants and children under four years of age average the highest rice intake, in part because they eat about three times the amount of food in relation to their body size, so there’s an especially “urgent need for regulatory limits” on toxic arsenic in baby food.

Pediatric nutrition authorities have recommended that when it comes to rice and rice-based products, “arsenic intake should be as low as possible,” but how about as early as possible? Approximately 90 percent of pregnant women eat rice, which may end up having “adverse health effects” on the baby.

You can estimate how much rice the mother ate while pregnant by analyzing arsenic levels in the infant’s toenail clippings. “Specifically, an increase of 1/4 cup of rice per day was associated with a 16.9% increase in infants toenail [arsenic] concentration,” which indicates that arsenic in rice can be passed along to the fetus. What might that arsenic do? A quarter cup of rice worth of arsenic has been associated with low birth weight, increased respiratory infections, and, above that, a 5- to 6-point reduction in IQ, among other issues. So, “based on the FDA’s findings, it would be prudent for pregnant women to consume a variety of foods, including varied grains (such as wheat, oats, and barley),” which is code for cut down on rice. Saying eat less of anything, after all, is bad for business.

Once the baby is weaning, “what’s a parent to do?” Asks Consumer Reports, “To reduce arsenic risks, we recommend that babies eat no more than 1 serving of infant rice cereal per day on average. And their diets should include cereals made of wheat, oatmeal, or corn grits, which contain significantly lower levels of arsenic”—that is, rely on other grains, which are much less contaminated than rice. As the American Academy of Pediatrics has emphasized, “there is no demonstrated benefit of rice cereal over those made with other grains such as oat, barley, and multigrain cereals, all of which have lower arsenic levels than rice cereal.” As you can see at 5:28 in my video, reducing consumption of infant rice cereal to just two servings per week could have an even more dramatic effect on reducing risk.

 The proposed limit on toxic arsenic in infant rice cereals would end up removing about half of the products off the shelves. The FDA analyzed more than 500 infant and toddler foods, and the highest levels of toxic arsenic were found in organic brown rice cereals and “Toddler Puffs.” Based on the wording in the report, these puffs appear to be from the Happy Baby brand. Not-so-happy baby if they suffer brain damage or grow up to get cancer. A single serving could expose infants to twice the tolerable arsenic intake set by the EPA for water. I contacted the Happy Baby company and was told they “are not able to provide any comments” on the FDA’s results.

“Eliminating all rice and rice products from the diets of infants and small children up to 6 years old could reduce the lifetime cancer risk from inorganic arsenic in rice and rice products by 6% and 23% respectively.” That is, there would be a 6 percent lower chance of developing lung or bladder cancer later in life if infants stopped, and a 23 percent lower chance if young kids stopped. However, switching to other grains is a move described as “drastic and dramatic,” creating “a huge crisis”—for the rice industry, presumably—and therefore “not feasible at all.”

I was hoping Happy Baby, upon learning of the concerning FDA arsenic toddler puffs data (regardless of whether the data were about its brand or not) would have kicked its own testing and potential remediation into high gear like Lundberg did (see Which Brands and Sources of Rice Have the Least Arsenic?). But, unfortunately, in my email correspondence with the company, I got no sense that it did.


For more videos on this topic, see:

And here are five more:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

Covid vaccine ‘highly likely’ to work on UK variant, BioNTech says

Chief executive, Uğur Şahin, says team will know within two weeks if vaccine works or needs adaption

The chief executive of the German pharmaceutical company BioNTech has said he is confident its coronavirus vaccine works against the new UK variant, but that further studies are need to be certain.

Uğur Şahin told a press conference that his team had been working on trying to find out whether the vaccine worked on the UK variant or whether it would be necessary to adapt it. Results would be known within two weeks, he said.

Related: New Covid variant in UK: spreading Christmas fear?

The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.

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Belgian minister tweets EU’s Covid vaccine price list to anger of manufacturers

Pharmaceutical companies complain of breach of confidentiality after amount EU has agreed to pay for leading vaccines goes public

A Belgian minister has inadvertently blown the lid off a sensitive and commercial secret – the price that the EU has agreed to pay for the leading Covid vaccines.

Belgium’s budget state ecretary, Eva De Bleeker, posted the price list on Twitter, with the amounts of each vaccine that her country intends to buy from the EU. The tweet was quickly deleted, but not soon enough to prevent interested parties taking screenshots, which have now made it public knowledge.

Oxford/AstraZeneca: €1.78

Johnson & Johnson: $8.50

Sanofi/GSK: €7.56

Pfizer/BioNTech: €12

CureVac: €10

Moderna: $18

Continue reading…

Kite’s Tecartus (KTE-X19) Receives EC’s Conditional Marketing Authorization for R/R Mantle Cell Lymphoma

Shots:

  • The approval is based on P-II ZUMA-2 study assessing Tecartus in 74 patients with r/r MCL prior treated with anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib)
  • The study demonstrated an OR rate (93 %) with CR (67%), as assessed by an Independent RRC following a single infusion. In safety analyses, Grade 3 or higher CRS and neurologic events in 15% and 33% of patients
  • Tecartus is the first CAR T therapy in r/r MCL. With the approval, Kite becomes the first company with multiple approved cell therapies in the EU

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Glassdoor

The post Kite’s Tecartus (KTE-X19) Receives EC’s Conditional Marketing Authorization for R/R Mantle Cell Lymphoma first appeared on PharmaShots.

Ministers would be wise to play for time before ordering Sizewell C | Nils Pratley

Dashing ahead with a nuclear power station that’s modelled on Hinkley Point C would be reckless

This is the government’s problem as it reopens talks on a proposed nuclear power station at Sizewell C in Suffolk: it is contemplating ordering a replica of Hinkley Point C before the Somerset original has produced a single megawatt of electricity.

That is not a small point. Developer EDF’s pre-Hinkley version of its European pressurised reactor at Flamanville in Normandy is about a decade behind schedule. What’s more, EDF wants UK taxpayers or bill-payers to bear more of the construction risks at Sizewell, a less-than-compelling offer when you remember that Flamanville is also €9bn (£8.2bn) over budget.

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Deal or no deal: how life will look for key industries after Brexit

Companies are praying a trade agreement can be struck, but must prepare for talks to fail. Which will be most affected?

The scene is set for a showdown, and the future of the UK economy is at stake. Will Britain secure a free trade deal with the EU? Or will the prime minister choose to sail into uncharted waters, not only stepping outside the single market and customs union, as the UK will be even under a deal, but adding the tariffs and border checks that come with a no-deal Brexit?

Armed with a determination to end the transition period on 31 December, Boris Johnson is poised to force British businesses to sell their goods and services across the EU without any of the benefits that a deal offers, and with only a few days’ notice. Here we assess the impact on some of the worst-hit industries of securing a deal – albeit a slimmed-down one – compared with the alternative.

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Which Brands and Sources of Rice Have the Least Arsenic?

Arsenic levels were tested in 5,800 rice samples from 25 countries.The arsenic found in five servings of rice a week poses a hundred times the acceptable cancer risk. What did the rice industry have to say about that? When the story first broke in the media that U.S. rice had some of the highest arsenic levels in the world, the USA Rice Federation said, “Enough nonsense about arsenic already!” in the August 9, 2005, issue of USA Rice Daily, its daily newsletter. The study, in its mind, was “not only inaccurate in the highest degree, but also maliciously untrue.” One of the researchers responded, “By not addressing this problem [of arsenic] that has been ignored for decades, the U.S. cotton-belt rice industry is doing itself an injustice. “Had the problem been addressed in the past, given that it is well known that arsenic in paddy soils was a problem in the U.S….safe soils would have been identified and low grain arsenic rice varieties developed.” Instead, arsenic-resistant varieties have been developed that build up excessive levels of arsenic without dying themselves. I discuss arsenic levels in rice in my video Which Brands and Sources of Rice Have the Least Arsenic?.

Not all rice producers have been so dismissive, though. After a subsequent Consumer Reports exposé, one rice company detailed “how it is taking matters into its own hands.” Lundberg Farms started testing hundreds of samples of its rice to share the results with the FDA. “We’re committed to providing safe food,” said the CEO, “to really listening to our consumers, and dealing with this problem very openly….” Lundberg Farms isn’t just sharing its results with the FDA, but with everyone.

If you visit its website or go to 1:37 in my video, you can see it apparently followed through on its testing promise for its brown rice. Lundberg Farms use parts per million (ppm) instead of parts per billion (ppb) to make it look better than it is, but compared with the average U.S. brown rice level of 154 ppb, Lundberg does do better. In fact, at 80 ppb, its aromatic brown rice, presumably its brown basmati and brown jasmine, averages less than national white rice levels, as do, apparently, Lundberg’s red and black rices, at 90 ppb. In fact, none of its samples even reached the average U.S. brown rice level.

Consumer Reports found most other brands to be pretty comparable to the U.S. average arsenic levels in brown rice, as you can see at 2:15 in my video, including Uncle Ben’s and Walmart’s Great Value brand. Whole Foods, however, scored the worst with its 365 Everyday Value long grain brown rice, about a third higher than these others and exceeding the national average.

In the largest review to date, based on 5,800 rice samples from 25 countries, the highest total arsenic average came from the United States. U.S. studies averaged overall about double that of rice out of Asia, with the high levels in the United States blamed on “the heavy [historical] use of arsenic-based pesticides.” But arsenic levels were not the same across the United States. Yes, U.S. rice averages twice the arsenic of Asian rice and nearly all rice samples tested in upstate New York that were imported from India or Pakistan had arsenic levels lower than 95 percent of domestically produced rice. But, “[r]ice grown in the U.S. showed the widest overall range…and the largest number of outliers,” due primarily to where it was grown, as you can see at 3:01 in my video. There is significantly more arsenic in Texas and Arkansas rice than rice from California. California rice is comparable to rice produced around the rest of the world. These are presumably some of the data that led Consumer Reports to suggest brown basmati from California, India, or Pakistan might be among the safer rice choices.If the arsenic is from pesticides, would organic rice have less than conventionally grown rice? No, because arsenic pesticides were banned about 30 years ago. It’s just that 30,000 tons of arsenic chemicals had already been dumped onto cotton fields in the southern United States, “so it is understandable that arsenic residues still remain in the environment” even if you don’t add an ounce of new pesticides. That’s why the industry specifically selects for arsenic-resistant varieties of rice plants in the South. If only there were arsenic-resistant humans.

What about other brands of rice? That was the subject of Which Rice Has Less Arsenic: Black, Brown, Red, White, or Wild?.


For even more background, see:

 You may also be interested in:

Kudos to Consumers Union, the wonderful organization that publishes Consumer Reports, for its pioneering work on this and so many other topics.

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

Kaia Health Allied with Chiesi Group to Commercialize COPD App in Europe

Shots:

  • Kaia Health signs an exclusive agreement with Chiesi Group to commercialize the Kaia Health COPD Pulmonary Rehabilitation app in the EU
  • The app is CE marked in EU as a Class 1 medical device and has been investigated in one pilot trial and is the subject of an ongoing randomized control trial in the EU
  • The Kaia COPD solution consists of a mobile app and an interface for motivational support that aims to deliver a personalized pulmonary rehabilitation experience through education, daily training sessions, and stress relief exercises, boosted with human coaching support and individualized therapy

Click here ­to­ read full press release/ article | Ref: Kaia Health | Image: Venture Beat

The post Kaia Health Allied with Chiesi Group to Commercialize COPD App in Europe first appeared on PharmaShots.

BioNTech’s Covid vaccine is a triumph of innovation and immigration | Hans-Werner Sinn

Pioneered by a Turkish-German couple, its significance exceeds its practical value

The world took note when the German startup BioNTech announced its breakthrough in the development of a new type of vaccine to combat Covid-19. After testing tens of thousands of people, BioNTech’s vaccine has been shown to be 95% effective in providing protection for those who would otherwise have been infected. The company was the first to apply for emergency use authorisation for a coronavirus vaccine in the US and it has announced it will soon take similar steps in Europe.

Antiviral vaccines are usually made with devitalised viral materials fabricated outside the body but BioNTech has pursued a new method of injecting genetically modified RNA into the patient. This prompts the patient’s cells to produce a characteristic protein of the relevant Sars-CoV-2 virus themselves, enabling the body’s immune system to build up an effective response before it encounters the real virus.

Related: Uğur Şahin and Özlem Türeci: German ‘dream team’ behind vaccine

Continue reading…

Why Was Chicken the Primary Source of Arsenic Exposure in Children?

What was the National Chicken Council’s response to public health authorities calling for the industry to stop feeding arsenic-based drugs to poultry?

“Dietary practices influence our exposure to pesticides, toxic heavy metals, persistent organic pollutants, and industrial pollutants….A diet high in fish and other animal products, for example, results in greater exposure to persistent organic compounds and metals than does a plant-based diet because these compounds bioaccumulate up the food chain.” Researchers at UC Davis analyzed the diets of children and adults in California to see just how bad things have gotten.

Cancer benchmark levels were exceeded by all children—100 percent of children—for arsenic, the banned pesticides dieldrin and DDT, metabolite DDE, as well as dioxins, and not just by a little. As you can see at 0:51 in my video Where Does the Arsenic in Chicken Come From?, researchers found more than a hundred times the acceptable daily exposure for arsenic in preschoolers, school-aged children, parents, and older adults, about ten times the acceptable levels for various pesticides, and up to a thousand times the daily dose for dioxins. Where are all these toxins coming from?

The number-one source of dioxins in the diets of Californian preschoolers, kids, parents, and grandparents appears to be dairy for all age groups, followed by meat, and then white potatoes, refined grains, mushrooms, poultry, and fish.

These days, our DDT legacy is also mostly from dairy. Dieldrin was created as a safer alternative to DDT, but it was banned just two years later, in 1974, though it’s still found in our bodies, mostly thanks to dairy, meat, and, evidently, cucumbers.

Chlordane made it into the 1980s before being banned, though we’re still exposed through dairy (and cukes). Lead is — foodwise — also mostly from dairy, and mercury is not surprisingly mostly from tuna and other seafood. But the primary source of arsenic in children? Surprisingly, mostly from chicken. Why?

Let me tell you a tale of arsenic in chicken. Arsenic is “well known as a poison by anyone who reads mysteries or the history of the Borgias, and with its long and colourful history, arsenic is not something that people want in their food.” So, when a biostatistics student went to the USDA in 2000 in search of a project for his master’s degree, he decided to look into it. He found a startling difference: Arsenic levels in chicken were three times higher than in other meats. His veterinary colleagues weren’t at all surprised and explained that four different types of arsenic-containing antibiotic drugs are fed to poultry—and have been fed to them since 1944.

“While arsenic-based drugs had been fed to poultry since the 1940s, recognition of this source of exposure [for humans] only occurred after appropriate statistical analysis of the data”—that is, after this student churned through the data. It was published in 2004 and expanded upon in 2006. The National Chicken Council (NCC) was none too pleased, saying lots of foods are contaminated with arsenic. “By focusing specifically on chicken, IATP [the Institute for Agriculture and Trade Policy] makes it clear that it is producing a publicity-oriented document focused on the objective of forcing [chicken] producers to stop using these safe and effective products”—by which the NCC means these arsenic-containing drugs. In fact, the NCC admits to using them but says we don’t need to worry because chicken producers use organic arsenic, “not the inorganic form made infamous in ‘Arsenic and Old Lace.’” Okay, so we don’t need to worry—until, apparently, we cook it. When chicken is cooked, it appears that some of the arsenic drug in the meat turns into the ”Arsenic and Old Lace” variety. So, the Poison-Free Poultry Act of 2009 was introduced into Congress, flopped, and was followed by the subsequent introduction of the Poison-Free Poultry Act of 2011. Did the second attempt fare any better? No, legislators once again said pish posh to poison-poor poultry. So, in 2013, a coalition of nine organizations got together and sued the FDA, and by December 31, 2015, all arsenic-containing poultry drugs were withdrawn. As of 2016, arsenic is no longer to be fed to chickens. The bad news is that without giving birds the arsenic-containing drug roxarsone, chicken may lose some of its “appealing pink color.”

In the end, the poultry industry got away with exposing the American public to arsenic for 72 years. “It should be noted that the European Union has never approved drugs containing arsenic for animal consumption” in the first place, saying, Hmm, feed our animals arsenic? No thanks, nein danke, no grazie, non, merci.

Europe has also long since banned the “urgent threat to human health” posed by feeding farm animals millions of pounds of human antibiotics. As you can see at 5:30 in my video, feeding chickens en masse literally tons of drugs like tetracyclines and penicillins to fatten them faster is a problem that gets worse every year instead of better and dates back to 1951 when drug companies whipped out the ALL CAPS in advertisements,  promising “PROFITS…several times higher!”, a dangerous practice the poultry industry has gotten away with for 68 years…and counting.


If you don’t eat poultry and are feeling a little cocky, you may want to check out my 12-video series on arsenic in rice before you gloat too much:

Think feeding arsenic to chickens is weird? Check out Illegal Drugs in Chicken Feathers.

And for more on the critical public health threat posed by antibiotic overuse in animal agriculture, see:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

The calm after the storm: How COVID-19 is making pharma more resilient

COVID-19 is proving to be the perfect storm in terms of the supply of pharmaceutical products. But learning how to overcome the challenges of 2020 will serve the industry well for years to come. As part of our EU Leader series, Christian Pawlu, head of strategy, portfolio and BD&L at Sandoz, told us about how securing supply in a time of crisis will ensure future access, build resilience, and transform relationships.

Since the start of the year, pharmaceutical companies have been riding a rollercoaster of challenges. Pawlu describes a “perfect storm” as the various strands came together to threaten supply chains.

“First, we saw a doubling or tripling of usual demand for a lot of our products. At the same point, there were big worries about supply chains in China.

“Then, as we went further into the crisis, there were some almost protectionist moves in some countries, as they placed or considered export bans on active pharmaceutical ingredients (API).”

Navigating this rapidly evolving landscape presented a challenge, but not an insurmountable one, Pawlu says.

“The industry, and our company in particular, always has business continuity plans in the drawer. But never in recent history have we had to pull out strategies for so many of our products and subsidiaries at the same time and put them into place.”

Daily calls with supply chain colleagues, activating second sources and alternative supply chains, along with strategic API and finished product stockpiling, all contributed to an absence of any major disruptions.

“For us, the crisis was also a reminder of our purpose as a company: to provide and pioneer access to the patient. We were the first company to commit to keeping prices stable for drugs seen as essential treatments for COVID-related symptoms.

“As an industry, we will have to be more honest with ourselves. We’ll be much better able to see where we have a really deliverable message and when we elicit a response, rather than measuring it by the time people spend with the customer”

“We made a commitment early on that we would not want to benefit from any shortages. In addition, we have made a commitment to provide 15 drugs to low-income countries at cost.”

Remote pharma

COVID-19 has fundamentally changed the way all sectors work on a day to day basis, but pharma did not have the luxury of time in allowing these changes to bed in.

Within a week, all 100,000 employees at Sandoz and parent company Novartis had transitioned from office to remote working, a process Pawlu describes as relatively “frictionless”.

“The biggest challenge was the interaction with our customers, because we weren’t able to see healthcare providers physically anymore. But, in the end, that turned out to be an opportunity.”

Before the pandemic, Sandoz was able to reach around 15% of its customers digitally, but that has now increased to around 70%.

As people adjusted to connecting digitally, through Zoom, Microsoft Teams, and other video-based software, in their private lives, this expanded into their professional lives, says Pawlu.

“Traditionally, the way we interact with our customers has been a big barrier to conveying messages, particularly in off-patent pharma.”

While using digital channels will not necessarily be easier, it will make companies think differently about how best to interact with healthcare professionals, Pawlu believes.

He says: “The key question we need to ask ourselves is, if we have more access to physicians, how do we want to use it? More reach? More efficiency?

“We are working through this as we speak and are thinking how we complement or even replace the traditional channels, and how we can reach customers we haven’t reached so far. It’s exciting.”

As the industry moves from a face-to-face to digital communication model, it needs a change of mindset, he adds.

“A physical person showing up in a physical office is the old normal.

“As an industry, we will have to be a bit more honest with ourselves. We’ll be much better able to see where we get access, where we have a really deliverable message, and when we elicit a response or an active request for follow up, rather than measuring it by the time people spend with the customer.”

Resilient future

Another change Pawlu hopes is here to stay is the increased communication and collaboration between industry and policy makers.

This is, in part, thanks to a greater appreciation of the importance of resilient supply chains, he says.

“Over the last 30 years, the volume of products produced in Europe versus Asia has flipped. The majority of APIs and an increasing share of FDF is currently being manufactured in Asia,” explains Pawlu, adding that this was driven, particularly in generics, by price.

“I think the balance we need to keep in mind is cost, quality, and resilient supply. You can optimise all three, but you can only maximise two at the same time.

“If you can go for the highest quality and resilient supply, you will have to pay a higher cost, or you do it the other way around – of course we never want to compromise on quality.”

Supply chain issues during the pandemic have brought this argument into sharp focus, and it is now “on the radar” at an international level.

“Sandoz has been in contact with heads of governments across Europe, and I’m extremely happy that this topic has gained so much attention,” he says, adding that the European Commission has committed to developing a continent-wide pharma strategy.

Back in July, Sandoz announced that it had entered a partnership with the Austrian government to keep production of penicillin at the company’s Kundl facility – the last remaining integrated production chain for antibiotics in the western world.

“Austria is something that’s been very visible, but we’re having similar discussions on other product areas with other governments,” Pawlu says.

Ultimately, 2020 has been a challenging time for pharma, but it has also presented a myriad of opportunities to learn and evolve.

For Pawlu, COVID-19 has highlighted how we transform the way the industry works – from manufacturing and supply chains, to sales and detailing – in a way that ensures everyone can access the high quality, affordable medicines they need to live happier, healthier lives.

About the interviewee

Christian PawluChristian Pawlu is the global head, strategy, portfolio and BD&L for Sandoz and a member of the global Sandoz Executive Committee. Christian studied medicine in Germany, Canada and France and is a licenced physician. Before he joined Sandoz, Christian was a start-up entrepreneur.  He was a partner at McKinsey & Company where he specialised in pharmaceuticals and medical products with a focus on generic drug manufacturers. Prior to joining McKinsey, Christian was a neuroscience researcher at the university of Freiburg, Germany. Christian is married to a professor of medicine and they have three children.

About the author

Paul TunnahDr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content marketing/communications consultancy (www.pharmaphorumconnect.com). He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations.

In June 2020, he became chief content officer for Healthware Group, a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a unique range of services combining design, strategy, communication and innovation with technology and corporate venturing.

Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or https://twitter.com/ptunnah

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BioNTech chief rejects Trump claim it delayed Covid vaccine news

Exclusive: Ugur Şahin says he and Pfizer CEO received results night before announcement

The scientist behind the BioNTech/Pfizer coronavirus vaccine has defended his company from Donald Trump’s accusation that it deliberately delayed news of its rapid progress until after the election, saying “we don’t play politics”.

BioNTech, a German company, and the US pharmaceutical giant Pfizer announced on Monday that their jointly developed vaccine candidate had exceeded expectations in the crucial phase 3 vaccine trials, proving 90% effective in protecting people from coronavirus infections.

The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

Continue reading…

FTSE 100 recovers to highest level since June after vaccine unveiled

Promising clinical data from Pfizer and BioNTech help the index to a £28bn one-day gain

Optimism that a mass rollout of Covid-19 vaccines will lead to an economic recovery lifted stocks in London again on Tuesday, to their highest closing level in over four months.

London’s FTSE 100 index of blue-chip shares rallied by nearly 1.8% to finish at 6,296 points, the highest close since 23 June. This added £28bn to the index’s value, taking its gains so far this week to nearly £100bn after it surged 4.6% on Monday on news of a vaccine breakthrough.

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Germany’s digital health changes will boost digital therapeutics in Europe

Digital therapeutics are gaining momentum worldwide and offer developers, including pharma, both a huge opportunity and a stimulating market access challenge, say Olaf Schoeman and Emanuele Arcà.

The last 12 months have shone a spotlight on digital transformation in Europe’s healthcare systems, with all the signs pointing to digital therapeutics (DTx) moving ever more into the healthcare mainstream.

Germany is spearheading these advances, particularly with its 2019 changes on national digital health reimbursement. The country will provide further momentum during its presidency of the Council of the European Union (EU), which runs from July until December 2020 and will see it work closely with the succeeding presidencies of Portugal and Slovenia. The countries have agreed a ‘trio programme’ to identify issues that would benefit from a fluid transition from one EU member state’s presidency to the next to form an 18-month agenda, with progress in digital health one of the highlights of their plans.

While we would not expect digital therapeutics to replace pharmaceuticals themselves, they could bring huge complementary benefits to patients and prescribers and, in doing so, could bring pharmaceutical companies perhaps as much value as the medicines they traditionally produce.

• Read the full article in pharmaphorum’s Deep Dive digital magazine

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Pfizer/BioNTech vaccine announcement is cause for cautious celebration

Interim trial results are encouraging as scientists welcome news

It is not yet the end of the pandemic, but the announcement by Pfizer/BioNTech that their vaccine has been 90% successful in the vital large-scale trials has got even the soberest of scientists excited.

These are interim results and the trial will continue into December to collect more data. The two companies – a tiny German biotech with the big idea and the giant pharma company Pfizer with the means to develop it – have not yet published their detailed data, so it is all on trust. And yet, nobody is suggesting the results have been over-egged. It looks as though the vaccine not only works, but works better than anyone hoped.

Related: Covid-19 vaccine candidate is 90% effective, says Pfizer

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BioNTech’s Covid vaccine: a shot in the arm for Germany’s Turkish community

Couple who set up and run firm are children of long-maligned ‘guest workers’ from Turkey

When the German biotechnology company BioNTech picked a street called An der Goldgrube or At the Goldmine in the western city of Mainz for its headquarters, the couple behind it could not have predicted how prophetic the address would turn out to be.

The company’s shares shot up 23.4% on Monday morning after the Covid-19 vaccine it is developing with the US pharma giant Pfizer became the first candidate worldwide to show positive results in phase 3 trials, the crucial final stage of testing.

Related: Covid-19 vaccine candidate is 90% effective, says Pfizer

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EMA starts rapid review of Bluebird’s gene therapy for rare disease CALD

Bluebird bio could be just a few months away from approval of its gene therapy for rare disease cerebral adrenoleukodystrophy (CALD) in the EU, after the EMA started an accelerated review.

If approved, Lenti-D (elivaldogene autotemcel or eli-cel) could transform the prospects of people with CALD, the most severe form of the neurodegenerative disease ALD that usually emerges in boys during early childhood and causes physical and mental disabilities as well as behavioural problems.

Around 40% of patients develop the cerebral form of ALD, which in turn affects around one in 17,000 live births.

A few weeks ago, Bluebird reported new data from the phase 2/3 STARBEAM trial of Lenti-D which showed that 87% of CALD patients were still alive and free of major functional disabilities after at least two years’ follow-up.

The EU filing comes ahead of a filing for eli-cel in the US, which Bluebird says should take place sometime towards the middle of next year, having been delayed by the coronavirus pandemic.

If approved, eli-cel would provide a one-shot treatment for CALD, holding back the progressive breakdown in the protective myelin that sheathes neurons.

It would be the first alternative to a stem cell transplant to treat the disease, a therapy that can provide significant improvements and even halt progression in some patients if given early enough.

However it requires high-dose chemotherapy to destroy the bone marrow, and that poses significant risks to patients in its own right, and can also lead to graft-versus-host disease, a potentially life-threatening complication in which the bone marrow donor’s immune cells attack the recipient’s cells and tissues.

CALD is caused by mutations in the ABCD1 gene located on the X chromosome, which provides instructions for the production of the ALD protein.

ALD protein is needed to clear toxic molecules called very long-chain fatty acids (VLCFAs) in the brain, and if mutated causes the VLCFAs to accumulate and damage the myelin sheath.

Using eli-cel, the patient’s own stem cells are modified in the lab to produce a working version of the ABCD1 gene, producing functional ALD protein that can help to flush VLCFAs from the body.

“CALD is a devastating disease, often marked by rapid neurodegeneration, the development of major functional disabilities, and eventual death,” said Gary Fortin, head of severe genetic disease programmes at Bluebird.

“If approved, eli-cel would represent the first therapy for CALD that uses a patient’s own haematopoietic stem cells, potentially mitigating the risk of life-threatening immune complications associated with transplant using cells from a donor,” he added.

Aside from STARBEAM, which will follow treated patients for up to 15 years, Bluebird is also conducting the phase 3 ALD-104 trial of eli-cel in CALD, which is due to generate results in 2024.

The EU filing for eli-cel comes shortly after Bluebird’s development partner received a 27 March 2021 FDA review date for anti-BCMA CAR-T cell therapy ide-cel, a potential therapy for multiple myeloma.

The biotech already has approval in Europe for Zynteglo, a gene therapy for haematological disease beta thalassaemia, and is due to file its related therapy LentiGlobin for sickle cell disease next year. The two therapies have been tipped to generate $1.5 billion-plus in peak sales by some analysts.

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GSK and Sanofi to start human trials of potential Covid-19 vaccine

World’s largest vaccine makers to begin testing on people in US with eye on rollout in early 2021

GlaxoSmithKline and Sanofi are to start testing their protein-based Covid-19 vaccine on humans for the first time, following promising results in earlier studies.

GSK, the world’s largest vaccine maker, and the French drugmaker Sanofi joined forces in April to work on an effective treatment to halt the devastating pandemic.

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Italian vaccine makers in race to produce flu doses before winter

Authorities order 50% more doses than in 2019 in bid to avoid hospitals being overwhelmed

Italian vaccine manufacturers are scrambling to produce millions of flu vaccination doses amid concern there will not be enough to meet demand this autumn and winter.

The country’s 20 regional authorities have so far ordered 17m doses between them – almost 50% more than in 2019 – as they seek to prevent the country’s health services from becoming overwhelmed if they also have to deal with a serious resurgence of Covid-19.

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Time for a health innovation pact: rethinking the design and delivery of healthcare

Janssen’s Anouk De Vroey on why we need to extend the public/private partnerships resulting from COVID-19 into more high-level dialogue on health innovation with governments.

Friday 13th March 2020 – I am not a superstitious person in general, but I will never forget that particular Friday the 13th, as it marked the start of the COVID-19 lockdown in Belgium.

Wishing someone good health is a common custom with a long history, but being and staying healthy has never been more important. Nor, indeed, collaboration. In 20 years of working in the pharmaceutical sector, I’ve seen a steadily increasing willingness to partner with others to optimise healthcare and accelerate scientific research – a willingness that has only been amplified by this new context in which we find ourselves.

COVID-19 continues to have a devastating impact on peoples’ lives and businesses, and it has brought into the sharpest focus the need for everyone to work together to find both immediate and long-term solutions.

Partnering on the road to European recovery

Industries and sectors have already joined forces to develop diagnostics, therapies and vaccines that could help tackle the disease. At Janssen Belgium, for example, we quickly set up a dedicated lab for COVID-19 diagnostic testing at our Beerse campus, in collaboration with the federal government, universities and other pharmaceutical companies.

We have also seen regulators and policymakers working at an incredible speed to streamline regulatory processes and put in place new emergency measures to support the search for potential treatments and vaccines.

No single person, company, or even industry can succeed alone in making COVID-19, or any other disease, a thing of the past. It’s going to take a tremendous joint effort. This pandemic has catalysed a spirit of collaboration and demonstrated what can be achieved when society comes together with one common goal. We must continue to make progress on some of the most pressing issues facing healthcare systems, and put in place a robust, long-term policy framework that supports and enables innovation.

We need to ask ourselves how this model of partnership and trust can improve future policy, as we still face many other global public health challenges. While some threats are unpredictable, others – such as the urgent need to tackle anti-microbial resistance (AMR) – are known, and we will be better prepared for future challenges if we can operate in a framework where public policy priorities and industry incentives are aligned.

Johnson & Johnson is one of the participants in the AMR Action Fund, recently set up by a group of leading biopharmaceutical companies in collaboration with the World Health Organization, The European Investment Bank, and the Wellcome Trust. The Fund has pledged to invest nearly $1 billion, with the aim of bringing two to four new antibiotics to market by 2030. If successful, I believe that we will see many more of these types of collaborations.

“This pandemic has catalysed a spirit of collaboration and demonstrated what can be achieved when society comes together with one common goal.. We need to ask ourselves how this model of partnership and trust can improve future policy”

Building a health innovation pact for the future

As the COVID-19 pandemic has continued to evolve, European citizens have been experiencing a dual-pronged crisis; firstly, as a result of the major strain placed on healthcare and, subsequently, due to the impact on the European economy.

However, these challenges are coupled with an opportunity to build on the crisis-born willingness to create healthcare systems that are better equipped to deliver value on both a local and global scale. We need to extend the public/private partnerships that have resulted from the crisis into a high-level, strategic dialogue with local governments and the European Union institutions.

  • In the short term, joint efforts to upscale screening, tracking, tracing and data capture should be prioritised until an effective vaccine is available.
  • During the crisis, there has been a transition to telemedicine solutions at a speed previously unheard of, so we should leverage these learnings to accelerate healthcare digitisation. Remote consultations and monitoring have provided an alternative to hospital visits, showing that digital options have the potential to free up resources in health systems, and enable patient-centric solutions where people can receive care in their own homes.
  • In the longer term, we need to work together with all stakeholders to co-create a blueprint for European healthcare systems that addresses tomorrow’s needs, including – but not limited to – establishing new payment models and a greater use of big data and real-world evidence.

At Janssen, we are more committed than ever to collaborating with healthcare authorities and the research and healthcare communities (both public and private), to achieve the common goal of improving the care patients receive. We want to enable people, resources and world-leading science to contribute to the EU recovery plan. But we are just one company. Reinforcing the importance of healthcare across Europe in the long run will only be possible with a strong and innovative contribution from the entire pharmaceutical industry.

What does policy progress look like?

We all have a responsibility to work together and create innovation pacts with society that foster progress and enable lasting change. These pacts would include:

  • Improving readiness for future challenges and disease prevention. We need a globally coordinated approach to the development, testing, approval and production of vaccines and treatments. Policymakers and the industry will need to work more closely to ensure appropriate mechanisms are in place to accelerate the rapid deployment of effective interventions across the globe. We also need to ensure that the healthcare of patients suffering from other diseases is not compromised during times of worldwide crisis.
  • Supporting value-based healthcare. Sophisticated methods are needed to define Key Performance Indicators (KPIs). The use of real-world data (RWD) on a vast scale can help improve patient outcomes, drive more comprehensive measurements of value, and support decision-makers as they assess different forms of treatment in the context of limited healthcare budgets. Regulatory and HTA processes must adapt and embrace a systematic use of RWD, and efforts to iron out the significant variability across European HTA systems should continue.
  • Developing healthcare solutions that are more patient-centric and can generate better outcomes. We must integrate the perspective of the patient into all levels of decision-making, using digital apps and devices where possible to involve patients in their entire treatment pathway.
  • Improving and maintaining a world-class system for the approval of medicines. The current focus on strengthening EU health agencies is encouraging, and the European Medicines Agency (EMA) has done well so far. But it is essential to keep pace with scientific progress. The European Centre for Disease Prevention and Control (ECDC) should play a pivotal role in coordinating surveillance, preparedness and response – leaving each European country to do this independently could jeopardise the EU’s ability to lead on healthcare and science policy.

I hope, in time, that we will look back on Friday 13th March 2020 as not only the start of the Belgian lockdown, but also as the beginning of a healthy European future; one that brings together science and robust policymaking, and sees more trust and greater transparency between partners. An innovation health pact between industry and health authorities could make this vision a reality. A unilateral focus on short-term austerity measures will not.

If we can strengthen a framework that incentivises innovation, we can help provide society with opportunities to access essential vaccines and transformational therapies in areas where optimal solutions do not currently exist.

 

About the author

Anouk De Vroey is senior director, government affairs & policy EMEA at Johnson & Johnson. She is a member of the Janssen EMEA Leadership Team and also leads the Janssen External Affairs Council, driving the way the company responds to the external environment. Anouk advocates for policies across EMEA that can ensure optimal access to care for patients, and is also involved in several platforms that support a climate of biopharmaceutical innovation. Prior to joining Johnson & Johnson, Anouk was European Lead of the Global Policy, Advocacy & Government Affairs department at Bristol-Myers Squibb.

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The Guardian view on Brexit bureaucracy: tied up in red tape | Editorial

Businesses already struggling with the fallout from Covid-19 will be forced to deal with a mountain of new bureaucracy in the middle of a deep recession

The government did not quite achieve the Brexit breakthrough it was seeking on Friday, when there was hope that a fast-tracked trade agreement with Japan might be reached. But it seems likely that a deal, essentially replicating one signed by the EU and Japan last year, will be done by the end of the month. Some kind of morale booster for Britain’s battered and bruised businesses would certainly be welcome.

As the clock runs down to the end of the transition period on 31 December, ministers are no longer bothering to offer the false hope of a relatively frictionless trade agreement with the EU. Even a Canada-style free trade deal will mean a vast infrastructure of compliance and checks: permits for lorry drivers to enter Kent, huge customs clearance centres and tracking apps are all in the mix. The government estimates that, from 2021, there will be over 400m extra customs checks a year on goods going to and from the EU.

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Armpit Shaving and Breast Cancer

Shaving before applying underarm antiperspirants can increase aluminum absorption. Could this explain the greater number of tumors and the disproportionate incidence of breast cancer in the upper outer quadrant of the breast near the armpit?

A famous case report called “The Mortician’s Mystery,” published in the New England Journal of Medicine back in the 1980s, described a man whose testicles started shrinking and breasts started growing. It turns out the mortician failed to wear gloves as he massaged embalming cream onto corpses. It was concluded there must have been an estrogenic compound in the cream that was absorbed through his skin into his body, one of the first such cases described.

This case was cited as inspiration by a group of researchers who came up with a new theory to explain a breast cancer mystery: Why do most breast cancers occur in the upper outer corner of the breast? The standard explanation was simply because that’s where most of the breast tissue is located, as the so-called tail of the breast extends up to the armpit, but that doesn’t explain the fact that it wasn’t always this way. Indeed, there has been a shift toward the appearance of breast cancer in the upper corner of the breast. And, it also doesn’t explain why “greater genomic instability”––chromosome abnormalities––has been “observed…in outer quadrants of the breast,” which may signal precancerous changes. There definitely seems to be something happening to that outer side of the breast, and it’s something relatively new, occurring in the last 50 years or so.

Is it possible that the increasing use of [underarm] antiperspirant which parallels breast cancer incidence could also be an explanation for the greater number of ductal tumours…and disproportionate incidence of breast cancer in the upper outer quadrant” of the breast near the site where stick, spray, or roll-on is applied? I discuss this possibility in my video Antiperspirants and Breast Cancer, where you can see a graph of U.S. breast cancer incidence and antiperspirant/deodorant sales at 1:38.

There is a free flow of lymph fluid back and forth between the breast and the armpit. If you measure aluminum levels in breasts removed during mastectomies, the “aluminum content of breast tissue in the outer regions [near the armpits]…was significantly higher,” presumably due to the “closer proximity to the underarm” area.

This is a concern because, in a petri dish at least, it has been demonstrated that aluminum is a so-called metalloestrogen, having pro-estrogenic effects on breast cancer cells. Long-term exposure of normal breast tissue cells in a test tube to aluminum concentrations in the range of those found in breasts results in precancerous-type changes. Then, as you can see at 2:41 in my video, once the cells have turned, those same concentrations “can increase the migratory and invasive activity of…human breast cancer cells” in a petri dish. This is important because women don’t die from the tumor in the breast itself, “but from the ability of the cancer cells to spread and grow at distant sites,” like the bones, lungs, liver, or brain. But, we don’t care about petri dishes. We care about people.

In 2002, a paper was published in the Journal of the National Cancer Institute in which the underarm antiperspirant habits of 800 breast cancer survivors were compared with those of women who had never gotten breast cancer, the first study of its kind. The finding? No indication of a link between the two.

Based on this study, Harvard Women’s Health Watch assured women that antiperspirants do not cause breast cancer and “women who are worried that antiperspirants might cause breast cancer can finally rest easy.” But two months later, another study was published that found that “frequency and earlier onset of antiperspirant/deodorant usage with underarm shaving was associated with an earlier age of breast cancer diagnosis.” As you can see at 3:56 in my video, it’s as much as 20 years earlier in women using antiperspirant and shaving their armpits more than three times a week. And, the earlier they started before versus after age 16 appeared to move up their breast cancer diagnosis by 10 or 20 years. The researchers concluded that “underarm shaving with antiperspirant/deodorant use may play a role in breast cancer” after all.

But what does shaving have to do with it? Shaving removes more than just armpit hair. It also removes armpit skin; you end up shaving off the top skin layer. And, while there is very little aluminum absorption through intact skin, when you strip off the outer layer with a razor and then rub on an antiperspirant, you get a six-fold increase in aluminum absorption through the skin. Though this is good news for women who don’t shave, the high transdermal, or through-the-skin, aluminum uptake on shaved skin “should compel antiperspirant manufacturers to proceed with the utmost caution.”

Both European safety authorities and the U.S. Food and Drug Administration (FDA) specifically advise against using aluminum antiperspirants on damaged or broken skin. However, shaving before antiperspirant application “can create abrasions in the skin…thereby negating the specific warning by the FDA and EU.” (I’m sure everyone knows about the FDA’s cautionary advice, having read Title 21 Part 350 Subpart C50-5c1 of the Code of Federal Regulations.)

We get so much aluminum in our diet from processed foods—such as anticaking agents in pancake mix, melting agents in American cheese, meat binders, gravy thickeners, baking powder, and candy—that the contribution from underarm antiperspirants would presumably be minimal in comparison. “But everything was turned topsy-turvy in 2004,” when a case was reported of a woman with bone pain and fatigue suffering from aluminum toxicity. Within months of stopping the antiperspirant, which she had been applying daily to her regularly shaved armpits, her aluminum levels came down and her symptoms resolved. Although not everyone absorbs that much aluminum, the case “suggests that caution should be exercised when using aluminum-containing antiperspirants frequently.”

Recently, as you can see at 6:29 in my video, it was shown that women with breast cancer have twice the level of aluminum in their breasts compared with women without breast cancer, though this doesn’t prove cause and effect. Maybe the aluminum contributed to the cancer, or maybe the cancer contributed to the aluminum. Maybe tumors just absorb more aluminum. Subsequent research has suggested this alternative explanation is unlikely. So, where do we stand now?

The latest review on the subject concluded that as a consequence of the new data, given that aluminum can be toxic and we have no need for it, “reducing the concentration of this metal in antiperspirants is a matter of urgency.” Or, at the very least, the label should warn: “Do not use after shaving.” Of course, we could cease usage of aluminum-containing antiperspirants altogether, but then wouldn’t we smell? Ironically, antiperspirants can make us stink worse. They increase the types of bacteria that cause body odor. It’s like the story with antidepressant drugs, which can actually make one more depressed in the long run (as I discuss in my video Do Antidepressant Drugs Really Work?). The more we use antiperspirants, the more we may need them, which is awfully convenient for a billion-dollar industry.

Is there any way to decrease body odor through changes in diet? An early video of mine discusses Body Odor and Diet, and I have some new updated ones coming down the pike!


What else can we do to decrease breast cancer risk? See, for example:

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

How does HTA for orphan drugs differ across europe?

New research looks at the factors that speed up and slow down HTA appraisals for rare disease medicines across Europe.

Rare diseases drugs have always faced challenges when it comes to HTA approvals, even as governments bring in more regulatory policies that make their path through assessment easier.

Several factors make it difficult for HTA bodies often to assess orphan drugs, including a lack of robust trial data due to difficulties in finding patients, the absence of randomised controlled trials, the use of surrogate endpoints, and the lack of active drug comparators.

A new analysis from consulting firm CRA has honed in on the different challenges faced in four EU markets – England, France, Germany and Scotland – and looked at how manufacturers can increase the chances of a successful appraisal.

The research analysed more than 70 EMA-approved rare disease therapies and compared reimbursement recommendations from the regulatory bodies in each country, to see how HTA decisions potentially prolonged time to reimbursement.

The results show that HTAs for orphan drugs can vary widely across Europe, causing inconsistencies in evidence requirements and recommendations.

Rates of approval

The study reviewed all 80 European Medicines Agency (EMA) authorised drugs receiving an orphan designation between 1 January 2013 and 31 December 2019, analysing their HTA outcomes and time to reimbursement across France, Germany, England and Scotland.

A comparative analysis was then conducted on the 71 approved drugs that achieved a negotiated price in at least one of the four markets.

Germany had the highest approval rate of orphan drugs at 98% – however most of these recommendations (73%) were awarded a ‘non-quantifiable benefit’ rating, the automatic rating for an orphan drug, which shows the regulator did not see any benefit compared to comparator products (see graph 1). The authors also note that orphan drug trials with higher p values and surrogate endpoints are often accepted for assessment in the country.

A more favourable outcome from the German regulator took on average 1.4 times longer to achieve a final negotiated price (708 versus 510 days).

graph 1

Graph 1: Assessment of the HTA outcome in France, Germany, England and Scotland of all orphan drugs that obtained an EMA approval between 2013-2019. N above each bar equals the number of drugs reviewed by the respective HTA body. Source: CRA Analysis

France and England had comparable approval rates (92% and 91%, respectively); however, France reviewed almost twice the number of orphan drugs over the period of analysis (67 versus 35). Only 19% of the orphan drugs in France were awarded an Amelioration du Service Médical Rendu (ASMR) rating of V, which indicates no improvement in medical benefit. Drugs with an ASMR IV-V rating were reimbursed in 427 days, compared to 585 days for products with ASMR I-III (see Graph 2).

Graph 2

Graph 2: Comparison of the time to reimbursement (days) for EMA orphan drugs approved from 2013- 2019. Orphan drugs were reimbursed in at least one of the selected markets (N = 70). N within each bar equals the number of drugs with each outcome reviewed by the respective HTA body. Source: CRA Analysis

In England, two key mechanisms were often used to achieve approval: label restrictions or a patient access scheme (PAS).

Over one third (37%) of orphan drugs appraised by NICE only achieved approval in a positioning or population that was restricted versus the full regulatory approved label. Companies that accepted such restrictions saw faster approval time compared to no drugs with restrictions (407 versus 505 days).

Meanwhile, although introducing a PAS improved the chance of approval, the analysis suggests that it actually delays the overall appraisal time (523 versus 311 days).

Scotland had the highest rate of non-approval for orphan drugs. Thirty-three percent of drugs reviewed were not accepted, despite specific modifiers in place for rare disease products, including the incorporation of the patient voice through the country’s Patient and Clinician Engagement (PACE) meetings – which were included in 74% of orphan drug submissions between 2013-2019.

Improving HTA outcomes

The authors conclude that while the various concessions and modifiers introduced by different governments have a positive impact on minimising rejections and accelerating approval times, there are still challenges in capturing the full value of orphan drugs within the HTA process.

“Achieving more favourable outcome ratings, avoiding restrictions, or addressing uncertainty with a PAS all lead to prolonged appraisal times,” the  authors say. “Manufacturers are therefore still required to consider carefully their HTA launch strategy and complement this with additional evidence generation and engagement from a wider stakeholder group.”

The authors outline several approaches companies can take to improve the chances of success in orphan drug approvals and overcome the challenge of having limited data and evidence available.

One approach is to agree methods for ongoing real world data collection post-launch with HTA bodies.

They add that “creative” solutions to real world evidence collection could help, such as developing apps for patients and HCPs.

Meanwhile, it is also important to strive for wider engagement with the rare disease community and other stakeholders.

Listening to views from patients and HCPs can help with processes like Scotland’s PACE meetings – but more indirect forms of stakeholder engagement may also improve HTA outcomes, as the value-added services provided to these stakeholders can be leveraged during negotiations.

“For example, Galafold, an enzyme replacement therapy for Fabry’s disease, is primarily differentiated from existing treatments by providing a reduction in administrative burden,” the authors say. “Despite this, Galafold was able to achieve an ASMR IV in France, recommendation by NICE, and was accepted for restricted use in Scotland.”

They note that the perception of Galafold’s value may have been improved by the additional value-added services the manufacturer, Amicus Therapeutics, offered to a wider stakeholder group

For example, Amicus reimbursed amenability tests for patients with unknown mutations that could be referenced against Galafold’s amenability table via a physician support website. This service was accepted in the NICE evaluation as something which avoided additional resource implications for the NHS.

For more information contact the report’s authors:

Steven Kelly – [email protected]

Ioanna Stefani – [email protected]

Charlotte Poon – [email protected]

Nimisha RaJ – [email protected]

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UK warns drug firms to stockpile in case of Brexit disruption

Companies should ensure six weeks’ worth of drugs for end of transition period, DHSC says

Pharmaceutical companies should stockpile six weeks’ worth of drugs to guard against disruption at the end of the Brexit transition period, the government has said.

The Department of Health and Social Care (DHSC) has written to medicine suppliers advising them to make boosting their reserves a priority.

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New digital health player HealthHero launches with Fernarzt buy

There’s a new kid on the block in digital health – called HealthHero – with aspirations to become the biggest company in the European market.

The new company officially comes into being today with the acquisition of Berlin-based telemedicine company Fernarzt, which was set up in 2017 and is already offering thousands of online consultations each month in Germany.

Ranjan Singh

HealthHero has been launched by Ranjan Singh, managing director of digital health for London based investment house MARCOL, which has bankrolled the Fernarzt acquisition.

Singh will serve as CEO of the group alongside his role as chairman of Medical Consultations, a 20-year-old telemedicine company based in the UK that is at the heart of the HealthHero group. He was named CEO of the UK company in February.

“Fernarzt is a great company, with an excellent team behind it,” said Singh, adding: “Germany is an exciting market for digital health, and Fernarzt provides us a solid platform to build the leading player in this sector.”

HealthHero has started operations with digital health services already available in the UK, Germany and Republic of Ireland covering around 4 million patients, according to the new company.

It is providing access to doctors and expert clinicians via video calls, online chats and phone, and says it has seen demand for its UK and Republic of Ireland services increase by over 300% during the coronavirus pandemic.

Fernarzt meanwhile has also seen a dramatic increase in usage since it launched a coronavirus consultation and contactless home testing kit service earlier this year, with tens of thousands of people in Germany making use of the facility every month.

MARCOL acquired Fernarzt from digital health company co-founder and investor HeartBeat Labs, which will remain a minority shareholder with 10% of the equity, and a strategic partner for the German market.

“The world has changed, but healthcare is failing to keep up,” says Singh. “Digital can provide the solution, but it has not yet succeeded. We are here to change that.”

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The Crowding Out Strategy to Eating Healthier

It may be more expedient politically to promote an increase in consumption of healthy items rather than a decrease in consumption of unhealthy items, but it may be far less effective.

The World Health Organization has estimated that more than a million deaths “worldwide are linked to low fruit and vegetable consumption.” What can be done about it? I explore this in my video Is it Better to Advise More Plants or Less Junk?

There’s always appealing to vanity. A daily smoothie can give you a golden glow as well as a rosy glow, both of which have been shown to “enhance healthy appearance” in Caucasian, Asian, and African skin tones, as you can see at 0:24 in my video.

What about giving it away for free?

A free school fruit scheme was introduced in Norway for grades 1 through 10. Fruit consumption is so powerfully beneficial that if kids ate only an additional 2.5 grams of fruit a day, the program would pay for itself in terms of saving the country money. How much is 2.5 grams? The weight of half of a single grape. However, that cost-benefit analysis assumed this minuscule increased fruit consumption would be retained through life. It certainly seemed to work while the program was going on, with a large increase in pupils eating fruit, but what about a year after the free fruit program ended? The students were still eating more fruit. They were hooked! Three years later? Same thing. Three years after they had stopped getting free fruit, they were still eating about a third of a serving more, which, if sustained, is considerably more than necessary for the program to pay for itself.

There were also some happy side effects, including a positive spillover effect where not only the kids were eating more fruit, but their parents started eating more, too. And, although the “intention of these programs was not to reduce unhealthy snack intakes,” that’s exactly what appeared to happen: The fruit replaced some of the junk. Increasing healthy choices to crowd out the unhealthy ones may be more effective than just telling kids not to eat junk, which could actually backfire. Indeed, when you tell kids not to eat something, they may start to want it even more, as you can see at 2:20 in my video.

Which do you think worked better? Telling families to increase plants or decrease junk? Families were randomly assigned to one of two groups, either receiving encouragement to get at least two servings of fruits and veggies a day, with no mention of decreasing junk, or being encouraged to get their junk food intake to less than ten servings a week, with no mention of eating more fruits and veggies. What do you think happened? The Increase Fruit and Vegetable intervention just naturally “reduced high-fat/high-sugar intake,” whereas those in the Decrease Fat and Sugar group cut back on junk but didn’t magically start eating more fruits and vegetables.

This crowding out effect may not work on adults, though. As you can see at 3:12 in my video, in a cross-section of over a thousand adults in Los Angeles and Louisiana, those who ate five or more servings of fruits and veggies a day did not consume significantly less alcohol, soda, candy, cookies, or chips. “This finding suggests that unless the excessive consumption of salty snacks, cookies, candy, and sugar-sweetened beverages”—that is, junk—“is curtailed, other interventions…[may] have a limited impact….It may be politically more expedient to promote an increase in consumption of healthy items rather than a decrease in consumption of unhealthy items, but it may be far less effective.” In most public health campaigns, “messages have been direct and explicit: don’t smoke, don’t drink, and don’t take drugs.” In contrast, food campaigns have focused on eat healthy foods rather than cut out the crap. “Explicit messages against soda and low-nutrient [junk] foods are rare.”

In the United States, “if one-half of the U.S. population were to increase fruit and vegetable consumption by one serving each per day, an estimated 20,000 cancer cases might be avoided each year.” That’s 20,000 people who would not have gotten cancer had they been eating their fruits and veggies. The U.S. Department of Agriculture recommends we “fill half [our] plate with colorful fruits and vegetables,” but less than 10 percent of Americans hit the recommended daily target. Given this sorry state of affairs, should we even bother telling people to strive for “5 a day,” or might just saying “get one more serving than you usually do” end up working better? Researchers thought that “the more realistic ‘just 1 more’ goal would be more effective than the very ambitious ‘5 a day’ goal,” but they were wrong.

As you can see at 4:56 in my video, those told to eat one more a day for a week, ate about one more a day for a week, and those told to eat five a day for a week did just that, eating five a day for a week. But here’s the critical piece: One week after the experiment was over, the group who had been told to eat “5 a day” was still eating about a serving more, whereas the “just 1 more” group went back to their miserable baseline. So, more ambitious eating goals may be more motivating. Perhaps this is why “in the US ‘5 a day’ was replaced by the ‘Fruits and Veggies—More Matters’ campaign…in which a daily consumption of 7–13 servings of fruits and vegetables – FVs –  is recommended.” However, if the recommendation is too challenging, people may just give up. So, instead of just sticking with the science, policy makers evidently need to ask themselves questions like “How many servings are regarded as threatening?”


For more on appealing to vanity to improve fruit and vegetable consumption, see my videos Eating Better to Look Better and Beauty Is More Than Skin Deep.

What does the science say about smoothies? See:

The flipside of free fruit programs is to tax instead of subsidize. Learn more by checking out my video Would Taxing Unhealthy Foods Improve Public Health?

For more on the paternalistic attitude that you don’t care enough about your health to be told the truth, see my videos Everything in Moderation? Even Heart Disease? and Optimal Diet: Just Give It to Me Straight, Doc.

I explore this same patronizing attitude when it comes to physical activity in How Much Should You Exercise?

In health,

Michael Greger, M.D.

PS: If you haven’t yet, you can subscribe to my free videos here and watch my live presentations:

 

Alnylam’s Anant Murthy on making it as a US biotech in Europe

Alnylam’s European head of market access and GM of mid-size markets, Anant Murthy, shares his perspective on how a US biotech can adapt to the many unique challenges of the EU market.

Though they represent the two biggest markets for pharma companies, the EU and US have some stark differences that can often catch out biotech leaders looking to expand from America into Europe.

Anant Murthy is one leader well-placed to know what it takes to succeed in the region. Originally from the US, he has spent much of his career in Europe, and now heads up market access and several EU countries for mid-sized Alnylam Pharmaceuticals, based in Switzerland, which specialises in RNA interference (RNAi) therapeutics.

He says that the biggest challenge people often face in bringing a US biotech to Europe is in accepting that some European markets will have no problem denying access to specific medicines.

“That’s really uncommon in the US, and for a lot of American biotech leaders who have not worked in Europe it’s a difficult thing to accept,” he says. “It’s a real possibility that an entire country will simply not allow access to a medicine, especially in many rare diseases.”

He adds that many companies have had to learn the unique difficulties in commercialisation in Europe through some challenging experiences.

“Building infrastructure in Europe takes a lot of investment – you need to hire people with skillsets across different countries, you need to build distribution infrastructure and you need to establish legal entities in many countries,” he says.

“I personally haven’t seen the type of change that I thought we would be facing in 2020 when I was imagining the future a few years ago”

“You have to do all that several times over just to access the EU. Meanwhile, the time to your first sale could be more than three years after a European regulatory review, and you’re still shouldering that entire infrastructure and all the costs associated with it during that time.

“A lot of emerging biotech companies have learned that the hard way, and many have learned that it’s better to schedule the timing of investments closer to the timing of revenues.”

Murthy stresses, though, that there are just as many opportunities for biotechs in the region as there are challenges – particularly as the sector moves toward highly specialised approaches to disease.

“We’re seeing a lot of interesting technologies focused purely on the biological mechanism of action behind the disease,” he says. “This is certainly true in the RNA field, and this new approach to medicine development has transformed Alnylam’s business.

“It affects how we do clinical trials and it affects the size of the commercial opportunities, because we can target very specific patients. Because of that, payers need to decide within the disease how to segment certain patient populations in order to maximise investments and get the best clinical benefit. That is quite disruptive, and I think that’s only going to continue.”

Murthy says this has also led to some innovative approaches to company formation.

“We’re now seeing a lot of biotechnology companies in Europe that are spinoffs of universities, based on platform technologies. This is great news – more biotechnology company creation leads to additional innovation, additional investments in research, and additional competition for European consumers.”

He also stresses the importance of partnering and collaborating with healthcare systems – which has only become more critical during the COVID-19 pandemic.

“The traditional model has always been somewhat transactional – we develop the medicine, they pay for it. Some of the more innovative biopharma companies are starting to blur those lines.

“Gene therapy is a great example, where you see proposals to engage in innovative, long-term payment models. These initial transactions are now leading to greater partnerships down the road.

“We believe there’s a need for more tailored agreement types like these that address uncertainty whilst limiting complexity and burden for payers. For example, we’ve created a value-based agreement framework for our new medicine for acute hepatic porphyria. This combines payment based on performance with additional financial mechanisms that address the short-term need to ensure payer value for money with the long-term view of budget responsibility, ensuring that what is committed to today is sustainable.”

Murthy adds: “Going forward, companies that want to be successful will need to find ways to be real partners in the development of medicines. That means investing in European research, partnering with European medical centres in developing medicines, and ensuring enrollment of European patients in clinical trials.”

A wide range of diseases

Alnylam’s work focuses on RNA interference therapeutics – which inhibit gene expression or translation by neutralising targeted mRNA molecules. Murthy notes that the field has become incredibly exciting over the last few years, and the company is hoping their new class of medicines will treat a range of diseases in the long-term.

“RNA interference is really a platform technology – it’s a naturally occurring biological process based on Nobel Prize winning research that began over 20 years ago. That basic understanding of biology is now transforming itself into real medicines. We’re only at the beginning.

“In the earlier stages of RNAi therapeutics, there were delivery challenges – how do you get these unstable RNAi molecules into the body without them degrading? Tremendous advances in biology, chemistry, and delivery of medicines have allowed us to go from applications that would require frequent infusions of high volumes of medicine to monthly or even quarterly subcutaneous injections.

“Now that we’ve cracked that delivery problem, the road is endless in terms of the number of diseases that we could address. We have announced research programmes in the CNS space, and have programmes in diseases ranging from hypercholesterolemia to pediatric diseases affecting the kidney. There are very few companies that could say that.”

And for a company that often deals with rare genetic diseases, the digitisation of healthcare services, delivery, and research has been a powerful boon.

“The biggest challenge with these conditions is often finding patients who are out there in the community. It’s unfortunate because they’re suffering when a treatment is already available, but you don’t find them until physicians can put the clues together.

“The digitisation of medical records and the ability, for example, to retrospectively screen records using risk factors or algorithms with propensity scores to find these people, has the potential to transform how physicians diagnose their diseases.”

However, Murthy says that while in other areas of digital health there are a lot of exciting concepts, he does not see much translation of those concepts into real practice.

“Fundamentally, the way most biopharma companies develop medicines hasn’t changed that much. In order for them to truly change, you need to look at the regulatory frameworks around research and development.

“I personally have not seen the type of change that I would have thought we would be facing in 2020 when I was imagining the future a few years ago.”

COVID and beyond

Alnylam has even been able to leverage its RNAi technology for a candidate to treat COVID-19, in partnership with Vir Biotechnology. The companies are aiming to move the asset into clinical trials at the end of the year.

“That has been a very rapid development process. In general, it has been tremendously exciting to see so many companies looking into developing or repurposing drugs to fight the pandemic.

“We’ve also noticed much more cooperation in the sector. Our president of research mentioned that it’s not uncommon for him to get a call from his counterpart in another company asking to compare notes in areas where we have expertise. That level of collaboration is really unprecedented.”

Conventional wisdom might say that the sector’s work during the pandemic will change how people view the industry for the better – but Murthy says there is some way to go in changing the appreciation of pharma’s value in Europe, and he hasn’t seen a noticeable shift yet.

“I hope that changes, but at the moment most of the recognition is framed around what the industry could bring to the economy for member states.

“When we meet with payers or government authorities, I’m frequently asked how many people we employ in their country, what our contribution to their GDP is, etc. If you are a small research-based biotechnology company, completely dependent on investment capital because you’re trying to bring forward cutting edge science, by definition you’re not going to be a major employer.

“If that is the standard by which European Union member states value our sector, that’s really going to devalue basic scientific innovation.”

Nevertheless, Anant says it’s important for people working in this industry to push themselves outside of their comfort zone if they want to make a difference in Europe.

“That’s how you really make an impact. Of course, that means there’s a chance you may fail because you’re going to be doing something that you’ve never done before – but that’s where the real opportunities lie.”

About the interviewee

Dr Anant MurthyDr Anant Murthy is currently a vice president at Alnylam Pharmaceuticals where he is the head of the MidSize Market Region, comprising Canada, the Nordics, Netherlands, Belgium, Luxembourg, and Portugal. In addition, he is the managing director of Alnylam Netherlands. Murthy is also the head of market access, pricing, and public policy, overseeing the company’s interactions with payers and governments across the European Union and Canada. He has led Alnylam’s successful launch of the world’s first RNA-interference medicine in several countries.

About the author

Paul TunnahDr Paul Tunnah founded pharmaphorum in 2009, which combines industry leading publications (www.pharmaphorum.com) with a specialist strategy and content marketing/communications consultancy (www.pharmaphorumconnect.com). He is a recognised author, speaker and industry advisor on content marketing, communications and digital innovation, having worked with many of the world’s leading pharmaceutical companies and the broader ecosystem of healthcare organisations.

In June 2020, he became chief content officer for Healthware Group, a next-generation integrated consulting group that operates at the intersection of the transformation of commercial operations and digital health, offering a unique range of services combining design, strategy, communication and innovation with technology and corporate venturing.

Connect with Dr Tunnah at https://www.linkedin.com/in/paultunnah/ or https://twitter.com/ptunnah

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