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#EAPM: Genetics, empowerment, and doner kebabs…

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Giant leaps in genetics have advanced certain key areas in medicine, (drugs and treatments, both) and have also shed light on what we might think of as anomalies, writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

For example, the majority of us know somebody who has, or has had, cancer but the reasons are not always clear.

Take the case of a healthy eater, who exercises daily, drinks moderately and has never smoked a cigarette - why would they expect to get cancer at, say, 45-years-old, when one of their contemporaries clangs off 30 cigarettes per day, has five pints of lager each night, eats Irish breakfasts and take-away doner kebabs almost daily, treats getting in-and-out of the shower as amounting to ‘exercise’, and yet has never had a major illness in their life?

OK, we know enough to guess that the clock is definitely ticking in the second example but, in the first-case scenario it could be, and probably is, simply down to genes.

DNA tests can throw up various likelihoods in advance of them happening, these days, although not everybody wants to know that they may have more chance of getting breast or colon cancer than their neighbour and it hardly seems fair when they do.

They may also not want to share the knowledge of a future likelihood of contracting a particular chronic disease with close family, as the latter could also be affected genetically and may not wish to know about that, thanks very much.

Some of the above may sound negative, yet genetics has, as mentioned, opened new doors for patients in the form of personalised medicine. It has often changed the ‘patient journey’, with new treatments available and better communication between doctors and patients.

These days, there is more co-decision as lifestyle, work and personal preferences come into play - especially with front-line healthcare professionals who are up-to-speed with the latest developments, or know where suitable clinical trials are taking place (many do not or, if they do, it is not flagged up as an option).

Of course, the quality of treatment varies from country-to-country, depending upon resources and incidence of a particular disease, and the awareness (or not) of potential over-treatment.

For example, not too long ago, men with prostate problems may well have had surgery “to get the cancer out”. In many cases it wasn’t actually necessary, at least not at that exact time, and could have been safely monitored instead. That would have made a significant difference to the victim’s lifestyle for some time.

And some may wonder at Angelina Jolie’s decision, knowing that her genes would probably have given her breast cancer. Should she have waited? Or was her empowerment for the best? The answer is, it was the actress’s decision and, without the knowledge that we now have, she possibly would not have made it and may have died early and unnecessarily.

So, over-treatment versus higher risk? It is a difficult choice and, in the past, doctors have basically been accustomed to making the decision, which often left the patient feeling powerless, scared and resentful, on top of being ill.

Patients are, for sure, not experts on medical matters. But they are absolute experts on their own lifestyles. Some doctors still don’t get that, and it needs too change.

Then again, we have a situation where empowerment differs depending on the disease. Is someone with a rare cancer, with no clinical trial group within a thousand miles, able to be as empowered as someone with a breast tumour caught early and treatable?

What if the EU member state is not the best at treating the condition, but suitable reimbursement is not available due to different costs in different countries with better resources in the particular case?

(We have, of course, cross-border treatment rights, but anyone working in this area would have to tell you, honestly, that it is far from living up to its potential, however well intended.)

Another issue is that drugs for rare diseases are, obviously, more expensive given the smaller market and the cost of development, trials, safety checks and the time taken to get approval to go on the market.

The EU population is living longer, and is suffering much more from co-morbidities (many diseases at the same time). Resources are stretched. Yet patients are also better-informed than they have even been (although too many ‘facts’ on the internet can send self-diagnosis in entirely the wrong direction).

So, unsurprisingly, there is a debate about how much ‘power’ a non-expert patient should actually have, and there is clearly a communication gap between the healthcare professional and the patient in many cases. Patients don’t always ask the right questions, and many doctors are unforthcoming unless asked specifically.

There is also a question of how much support a patient should have at the time of diagnosis, as well as afterwards. As ever, in all health-care systems, it always seems to be about cash.

Personalised medicine aims to put the patient right at the centre of his or her own healthcare, and that means taking decisions in concert with doctors, nurses and surgeons.

This fast-moving area of medicine also advocates better training for healthcare professionals and smarter use of resources, as well as cross-border sharing of health data, better coordination and collaboration in research, and the continuous exchange of knowledge and best practices.

Personalised medicine applies to the actual diagnosis, the treatment and ongoing, often lifestyle-based post-care, which has the aim of (usually) prolonging life and (almost certainly) maximizing the quality of life.

We are not in a position (yet) to change a person’s genetic make-up to remove the possibility of a specific disease (although certain immunotherapy methods are coming to the fore which better target treatment), and there are huge disagreements about the value of population-based screening (largely because of cost and the aforementioned risks of over-treatment, as well as the dangers of radiation in some instances).

Certainly, the Brussels-based EAPM, with its broad base of stakeholders, is in favour of screening for, for example, high-risk lung cancer groups, and has argued for it at various conferences and congresses down the years

In the end, EAPM believes it is all about giving the right treatment to the right patient at the right time, as well as about empowering the patient. And, given that there are a potential 500 million of them spread across the EU’s current 28 member states, that has to be a worthy goal in itself - whether or not that patient smokes, or doesn’t smoke, or has a weekly doner kebab (or three).

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EAPM: Beating cancer inequalities, getting ready for summer hols and transparency

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Good afternoon, health colleagues, and welcome to the European Alliance for Personalised Medicine (EAPM) update – there is much to discuss, on beating inequalities in cancer treatment, clinical data transparency and, importantly, planning for summer holidays writes EAPM Executive Director Dr. Denis Horgan.

Commissioner says EU cancer plan must ‘break the silence’ on women’s cancers

There is a large inequality of access to women’s cancer services and treatments across the EU, according to the bloc’s health chief, who highlighted the role of Europe’s Beating Cancer plan in bridging these disparities. Speaking during a webinar, Health Commissioner Stella Kyriakides said there is a need to “break the silence” and talk openly about gynaecological cancers. 

The EU, she added, has “to assure that all women in all corners of the EU, get the support, have access to the screening and the vaccination, the information and the multidisciplinary care that they should be having”. 

Her hopes are on Europe’s beating cancer plan, which must bring “real change”. “This is what European citizens expect from us. And I also believe that we don’t have a right to fail them. We have an opportunity and we need to seize it,” Kyriakides said. Europe’s Beating Cancer Plan was set in 2020 to tackle the entire disease pathway, from prevention to treatment, with the goal to equalise access to high-quality care, diagnosis and treatment across the bloc. 

About 40% of cancer cases are preventable through effective cancer prevention strategies. The commissioner added that the EU cancer plan “aims to offer breast cancer screening to 90% of people who qualify for it by 2025”.

EMA chief sceptical about waiving patents as answer to vaccine inequity

The head of the European Medicines Agency expressed scepticism that waiving patents on coronavirus vaccines will bring about equitable access, saying that instead the answer was increasing distribution and availability.

In an interview with several national European newspapers, EMA Executive Director Emer Cooke said that she firmly believes in “equitable access to vaccines and that nobody is safe until we are all safe,” when asked about the U.S. proposal for a vaccine patent waiver. 

“For me, however, the way to solve this problem at the moment is to increase the distribution and availability of vaccines,” she said, pointing to a significant number of doses set to be available over the next several months. 

Cooke said that the focus should be on “enabling innovation.” “None of our existing vaccines would have come about if there hadn’t been an environment that made innovation attractive,” she said. 

Despite this, Cooke conceded that in the “long term” the debate on patent protection should be carried out. 

More action on rare diseases

Any disease affecting fewer than five people in 10,000 in the EU is considered rare. Although this might appear small, it translates into approximately 246,000 people. Most patients suffer from even rarer diseases affecting 1 person in 100,000 or more. Approximately 5,000-8,000 distinct rare diseases affect 6-8% of the EU population i.e. between 27 and 36 million people.

Public Health Policy Director Anna Kole has said that the successful launch of Europe’s Beating Cancer plan had provided inspiration for the idea of creating a dedicated action plan for rare diseases. 

Meanwhile, the Commission is moving on several different fronts to improve rare disease treatment in the EU. An impact assessment evaluating proposals to change EU regulations for medicines for rare diseases and for children is expected to run until the first quarter of next year. That will open the door to new legislative changes. And creation of a European health data space will allow pooling data from rare disease patients across different member countries. 

Kole said that an action plan would allow better coordination across the disparate fields that the Commission is acting on, as well as the introduction of new flagship initiatives. 

“If there’s one disease area where EU added value can’t be more clearly demonstrated, it’s rare diseases,” said Kole, who pointed to the benefits of allowing patients to move across borders for specialist treatment, or for facilitating data sharing throughout the bloc, as examples.

The EU supports research into rare diseases through Horizon 2020, the EU Framework Programme for Research and Innovation. Horizon 2020 is the biggest EU Research and Innovation programme ever, with nearly €80 billion of funding available over 7 years (2014 to 2020). Close to €900 million, is available to more than 160 collaborative projects related to rare diseases.

Rich-poor vaccine inequity

The disparity in access to COVID-19 vaccines between rich and low-income countries has become impossible to ignore; according to UNICEF data, 86% of all doses given worldwide up to 30 March were administered to those in high- and upper-middle-income countries, while just 1% of jabs have been given to those in the world’s poorest. 

Low-risk groups in the UK, US and Israel are becoming eligible for jabs, while vulnerable populations elsewhere remain at risk of contracting the virus. The hoarding of vaccines by wealthy countries, as the pandemic ravages economically disadvantaged nations, has brought the issue of vaccine patents to the fore. 

Biotechnology Innovation Organization  wrote in the Economist that the proposal “undermines the very system that produced the life-saving science in the first place”, and “destroys the incentive for companies to take risks to find solutions for the next health emergency”. 

Regulators and WHO call for clinical data transparency

World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. In a joint statement, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) cited need for “wide access to clinical data for all new medicines and vaccines”. 

Data related to a therapy or vaccine “must be published at the time of finalization of the regulatory review,” they said, regardless of whether the decision is positive or negative. “It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.” 

The two bodies cited “overriding public health interest” in their statement, which called for pharmaceutical companies to report clinical trial results without redacting information that would otherwise be confidential because of commercial reasons. Only personally identifying information and individual patient data should be redacted from publicly available clinical trial data, wrote WHO and ICMRA. 

People can ‘start thinking about Europe summer travel’ 

People can start thinking about summer holidays in Europe on condition of being vaccinated, the EU has said, as its planned digital travel 'health pass' is on track for use from mid-June. The plan is that a European-wide health pass will be launched at the same time across the EU, and countries that do not have the resources to put it in place will be supported by the Commission, to avoid delays. Internal Market Commissioner Thierry Breton said: “I seriously believe that we can start thinking about [summer travel], probably like last year in Europe. “It will be important to open the continent gradually, and to be able to go on holiday. Everyone must go to get vaccinated. As soon as you are called, go to get vaccinated.”

Commission publishes open public consultation on the European Health Data Space 

The Commission has published an open public consultation on the European Health Data Space (EHDS) - an important building block of the European Health Union. The EHDS aims to make full use of digital health to provide high-quality healthcare and reduce inequalities. It will promote access to health data for prevention, diagnosis and treatment, research and innovation, as well as for policy-making and legislation. The EHDS will place individuals' rights to control their own personal health data at its core.

The consultation will remain open for responses until 26 July 2021. Health and Food Safety Commissioner Stella Kyriakides said: ″The European Health Data Space will be a crucial component of a strong European Health Union. It will enable EU-wide collaboration for better healthcare, better research and better health policy-making. I invite all interested citizens and stakeholders to take part in the consultation and help us leverage the power of data for our health. This will have to rest on a strong foundation of non-negotiable citizens' rights, including privacy and data protection.″ 

And that is everything from EAPM for now – stay safe, stay well, have a terrific weekend, see you next week.

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European Jewish chief asks heads of state to step up security of Jewish institutions due to rising threat

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Rabbi Menachem Margolin (pictured), the chairman of the Brussels-based European Jewish Association, has written to heads of state across Europe asking them to step up security around Jewish Institutions and increase their vigilance and monitoring of known extremist networks in light of the ongoing Israel-Gaza conflict.

Europe wide surveys by agencies such as the Fundamental Rights Agency (FRA) show that whenever there is a conflict between Israel and Palestinians, there is a marked uptick in incidents of an anti-semitic nature.

Rabbi Margolin relayed to the Heads of State that Jewish communities across the continent were concerned that if was not a matter of “if” but “when” reprisals against Jews and Jewish Institutions would take place.

In his letter the EJA head wrote:

I write with a heavy heart for having to do so, but with an urgent request for your consideration.

Figures prove that whenever Israel is engaged in skirmishes with Palestinian terror groups or others that seek to undermine Israel’s sovereignty, there is a sharp and marked uptick in antisemitic attacks across Europe.

In short, Jews are held responsible. Of course, this runs counter to the spirit and letter of the IHRA definition of antisemitism - namely that Jews should not be held responsible for events in Israel, but also that antisemitism and anti-zionism are two sides of the same coin.

Our association are hearing from our communities that they are concerned that it isn’t a case of ‘if’ but ‘when’ there will be reprisals and acts carried out against them because of the ongoing conflict. These concerns are not without foundation as we have already seen a number of angry demonstrations outside synagogues in parts of Europe.

I ask you humbly and respectfully to increase vigilance and security in and around Jewish Institutions by your forces of law and order during this tense and difficult time and to increase your monitoring of social media channels and extremist networks.”

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Airbus and Air France ordered to stand trial over 2009 crash

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Air France (AIRF.PA) and Airbus (AIR.PA) should stand trial for involuntary manslaughter over their role in a 2009 crash in the Atlantic that killed 228 people, the Paris court of appeal ruled on Wednesday. (12 May)

The ruling reverses a 2019 decision not to prosecute either company over the accident, in which the pilots lost control of the Airbus A330 jet after ice blocked its airspeed sensors.

Victims' families welcomed the ruling, but Airbus and Air France said they would seek to overturn it at the Cour de Cassation, France's highest appeal court.

"The court decision that has just been announced does not reflect in any way the conclusions of the investigation," Airbus said in an emailed statement.

Air France logo is pictured at the Air France check-in at Bordeaux-Merignac airport, as Air France pilots, cabin and ground crews unions call for a strike over salaries in Merignac near Bordeaux, France April 7, 2018. REUTERS/Regis Duvignau
The Airbus logo pictured at the company's headquarters in Blagnac near Toulouse, France, March 20, 2019.  REUTERS/Regis Duvignau

Air France "maintains that it committed no criminal fault at the root of this tragic accident", said a spokesman for the carrier, which is part of Air France-KLM.

Air France flight AF447 from Rio de Janeiro to Paris crashed on 1 June, 2009, killing everyone on board.

French investigators found that the crew had mishandled the situation arising from the loss of speed data from sensors blocked with ice and caused an aerodynamic stall by holding the aircraft's nose too high.

The earlier decision not to go to trial drew legal challenges from the families as well as pilot unions and prosecutors who had pursued charges against Air France alone.

Wednesday's ruling upheld new demands for a trial of both companies from senior prosecutors who have accused Air France of pilot training failures and Airbus for underestimating dangers posed by known problems with the speed sensors.

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