Category Archives: Government

Biotechnology, Government, Health, Medical, Science, Society

Genomic medicine is being blocked by the NHS

NHS: GENOMIC MEDICINE

THIS MONTH the NHS will become the first health service in the world to offer whole genome sequencing to patients where clinically appropriate. Heralded by NHS leaders as “a new era of genomic health”, the goal is to use these data and new technologies to decode and treat previously intractable diseases, to move away from symptomatic treatments to cures and prevention.

The Prime Minister has said she wants the UK to lead the world in this new area of science – to continue a tradition of innovation in this country that will “extend horizons and transform lives”.

Theresa May’s ambition to lead the world in genomics and precision medicines is one that we should all want to support. Scientists and doctors know that pioneering precision medicines and their advances change lives, but they will also be aware of the challenges that must be overcome to realise its potential. This is not necessarily because the science is lacking, but because a fundamental shift in thinking is still needed by governments, regulators and policymakers in how they assess the value of this innovation.

Cystic fibrosis (CF) is an excellent example of this challenge. In 1989, when the cystic fibrosis gene was first identified, scientists did not know how mutations in the gene caused the condition. There was nothing to treat the underlying cause of the disease and people could only seek treatment for their symptoms.

After nearly 20 years of research and development by hundreds of scientists, and the design, synthesis and testing of more than 400,000 unique molecules, they have now done what was once thought impossible – discovered and brought to nearly half of all CF patients the first medicines to treat the underlying cause of this devastating disease. Today, multiple medicines approved by the EU and U.S. now exist, and there are more coming down the line. The ultimate goal is to cure CF once and for all.

For this remarkable cycle of innovation to be completed, Governments must now play their part, by providing patients with access to these medicines. Three years after approval of these medicines, this has still not happened because scientific innovation is outpacing the UK medicines evaluation system.

The evaluation criteria and processes used by the NHS and the National Institute for Health and Care Excellence (NICE) are currently preventing them from being made available to patients. Despite universal acceptance of the benefits that these medicines will bring, people in the UK have been waiting for access for more than 1,000 days, while thousands of people with CF in other countries in Europe and the US have been benefiting from them for years.

CF patients don’t really have the time to wait. Half of those with this cruel disease will die before they are 31. Science has delivered the breakthroughs, but the system is blocking access. The UK has the second largest number of CF patients in the world.

In 2016, the UK’s own chief medical officer recommended a fundamental shift in how new transformative medicines are developed and appraised for use in healthcare systems. The appraisal system in the UK needs to reflect that the genes and pathways underlying genetic diseases seldom respond to traditional pharmaceutical approaches, and so precision medicine requires risk-taking innovation.

The Life Sciences Industrial Strategy, a report made to the Government just last year, echoes many of these sentiments. It outlines the need for industry to take on bold, far-sighted ambitions in the life sciences with the intention of creating commercial success, underpinned by novel technology and higher-risk science. The strategy singles out a handful of successful biotech companies with highly innovative products. Yet, unlike in many other European countries, the NHS and NICE have not yet followed these recommendations and evolved their evaluation criteria for these types of transformative precision medicines.

The Government must surely need to act, not just for more than 10,000 people currently living with CF in the UK, but also for people suffering from many other kinds of genetic diseases.

Genomic medicine stands on the cusp of becoming an everyday reality. Those institutions at the cutting edge of gene therapy and gene editing need a system that is already thinking about the innovations of tomorrow. Such systems need to incentivise innovators to get medicines into the hands of patients as soon as possible.

Organisations involved in scientific advances will never give up on their ambition to cure serious diseases that today might still seem impossible to tackle. While they continue to deliver on the science, the UK Government must show its commitment to biomedical innovation if the genomic revolution is to be fully realised.

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Britain, Europe, Government, Russia, Society

The prospect of an escalating global war is terrifyingly real

THE WEST AND RUSSIA

THERESA MAY made perhaps the most momentous statement of her political career at Westminster when, in a dramatic scene in the Commons, she effectively accused the Russian state of an act of war. She said the Kremlin had instructed its military intelligence agency, the GRU, to assassinate the defector Sergei Skripal in March.

Backed up by a wealth of irrefutable evidence about the two Russian intelligence agents who carried out the assignment, which ultimately resulted in the death of a British citizen and three other serious poisoning cases, Mrs May’s assertion has huge implications, not only for Britain’s relations with the rogue Russian regime, but also for European and Western foreign policy as a whole.

The Salisbury incident is truly shocking. It is the first time that a Briton has been killed on our home soil by a chemical weapon deployed by a foreign power. Yet until it happened, Britain seemed utterly indifferent to the brutality of Vladimir Putin’s government.

 

AFTER Putin sanctioned and authorised another well publicised assault on British soil in 2006, when ex-Russian secret policeman Alexander Litvinenko was murdered with a radioactive poison in London, the initial shock and anger soon ebbed away to apathy, thanks in large part to the feebleness of our Government’s response.

Whilst it is true that the British authorities were quick to name the Russian suspects, the speed of this early announcement was not matched by resolute action from the Government.

The huffing and puffing in Whitehall produced half-measures. That can only have reassured the Russian spymasters that they could get away with assassination.

Sine then we have all become aware of the litany of charges against Russia, like its seizure of Crimea, its blood-soaked intervention in Syria in aide of President Assad’s tyranny and its shooting down of the Malaysian airliner MH17 over rebel-held Ukraine in 2014.

But all those atrocities happened abroad, it was argued. They were nothing to do with us, so a proverbial slap on the wrists would surely do.

In contrast, from the start of the Skripal case, the Prime Minister has been far tougher, imposing sanctions, expelling Russian diplomats, galvanising NATO, and even winning the support of Donald Trump’s White House and the EU for her actions.

Admittedly, this was partly because the potential consequence of the Salisbury poisoning was even more serious than the Litvinenko case, given that Novichok put hundreds of lives at risk.

Nevertheless, the British Government has, despite all its problems with Brexit, displayed a commendable spirit of resolution that has been all too absent until now.

Through her clear-sighted resolution, Theresa May has mounted a direct challenge to Putin’s regime.

And although it has taken six months to name the alleged perpetrators, it has been worth the wait. Thanks to the thoroughness of the investigation, the sheer weight of incriminating material she was able to announce in the Commons means that the Russian state cannot slide away from its responsibility for this crime.

What her Commons statement also did was to blow apart the absurd conspiracy theories about the Salisbury assault that have been circulating, many of them promoted by Putin’s regime or by Kremlin sympathisers.

The evidence, gathered by 250 detectives from 11,000 hours of CCTV footage, shows incontestably where the blame lies. This raises the question as to why the Kremlin resorted to such an act. The answer lies in Putin’s security policy, which is so important to his macho political persona and the image of his regime’s invincibility.

As a former KGB officer himself, he has made ruthlessness a central part of his strongman reputation. It thereby enhances his appeal among the Russian people.

When he first came to power in 2000 on his election as Russian president, there were profound weaknesses in the country’s security apparatus, epitomised by the defections of agents like Litvinenko and Skripal.

 

SO much information was leaked after the fall of communism that Western intelligence thought they had crippled Russia’s GRU agency, giving MI6 and the CIA a window directly into Russian policymaking which helped them to predict the Kremlin’s actions.

But Putin changed all that through a pitiless crackdown. Internal security was vastly improved and leaks closed.

The CIA has privately admitted that many of its contacts in Moscow have gone silent. Some have disappeared. Others simply do not respond to efforts to contact them.

Dealing mercilessly with the defectors became an essential part of that security crackdown.

Since March, it has often been asked why Skripal, a former double agent, should still be a target, so many years after Putin let him out of the Gulag and allowed him to retire to Britain. It appears that Putin’s intelligence services have decided that letting defectors sleep soundly at night offers too much temptation for others to follow suit.

Kill one, frighten 10,000 is an old tactic, and one that the Russians seem to have adopted. Washington certainly believes that putting the fear of God into potential double-agents was the real reason for poisoning Sergei Skripal.

The Salisbury attack may also reflect Putin’s wider, geopolitical strategy, with its focus on dividing the West through surprise, propaganda and intimidation. Years ago he decided the West, particularly America and Britain, wanted to get rid of his regime.

Instead of asking what he could do to allay Western concerns, he adopted the opposite course by using Russian wealth from the country’s energy resources, plus the long experience of Soviet spycraft, to mount campaigns of disinformation and denial.

Until Salisbury, that strategy appeared to be working. The Novichok assault, however, led to an unprecedented act of unity – due in part to the British Government’s resolve.

The West hung together and backed Britain. The question now is whether this accord will last. The Prime Minister has said that she will be trying to mobilise the EU to harden sanctions on Russia and co-ordinate counter-measures against Russian intelligence operations in Europe.

That could be easier said than done. The wall of unity is already showing signs of cracking. Apart from the awkwardness created by Brexit, Putin’s policy of divide and conquer is also having an impact, for the Russian president has been soft-talking allies in the EU.

Last month, for instance, he was a guest at the Austrian foreign minister’s wedding, and Vienna’s Right-wing government is one of the loudest voices in the EU clamouring for improving relations with Moscow.

In Italy, the new government is led by a critic of sanctions against Russia, so imposing new ones is unlikely to win Rome’s support.

Yet, Britain cannot possibly let the Salisbury attack slide away into unpunished oblivion as it did the Litvinenko case.

The need for action is all the more important because, worryingly, the balance of global power is sliding away from the West. The U.S., Britain and the EU are still economically potent, of course, but the rise of China as both an economic and military superpower adds to the challenge posed by Russia and other states.

Even Turkey, a member of NATO, is moving away from the West under President Erdogan. The fact is that the Salisbury outrage is a graphic indicator that the world is becoming a less stable place. It was a rare but disturbing episode that exposed the nature of the escalating global war between spy agencies.

In its aftermath, that war is likely to intensify.

Which makes it all the more imperative that the Government is robust and vigilant. The West needs to be resolute and united in the face of Putin’s ruthlessness.

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Britain, European Union, Government, Politics, Society

Brexit: The last chance to restore trust

BREXIT BRITAIN

HAROLD WILSON once said a week was a long time in politics. In the present political climate, weeks must feel like eternities. Brexit has changed people’s views as the debate has raged on. For some, who were once moderate party members, have turned into hardened rebels; others who initially supported the Government’s approach now have real concerns about its direction.

Yet, the key conversation we should be having – one that has really been absent for too long – is what the next 15 or 20 years will look like; what we should actually do now, beyond the platitudinous slush, to ensure that the children of today and tomorrow can have a better life than us.

Deep down, our politicians must know that there is something amiss in the body politic of today. Populations are restless. People feel left out and ignored. The traditional levers to improve the world are malfunctioning – there is slower growth, foreign policy chaos and domestic budget stricture. The status quo appears brittle and worn. Where is the clarity about what to replace it with? The world is turning, and, for many, it appears to be turning away from them.

Underneath that sense of foreboding are two existential issues. The first is technology. In the lifetime of those born in the 1960s have seen the advent of the home computer, the internet and the mobile phone. Millions of jobs have been created by a medium that was invisible a generation ago and which, most likely, will have changed beyond recognition by the next.

Yet, even in normal times, politicians’ answer to technology is to either ignore it or grandstand on it. Take the tech giants and their questionable data practices. The elite have gone to town on them in recent months. CEOs have been chastened. Companies run warm adverts saying things like ‘we’ve changed’ without proper public consideration of what, over the long-term, we all need to change to.

The country’s focus on Brexit has meant we’ve missed the underlying, hard questions. Are they platforms or publishers? Are they monopolists or innovators? How do individual nation states regulate cross-border activity? The amount of time that politicians spend in legislatures debating the philosophical, economic and social impacts of artificial intelligence, big data and the loss of privacy is inversely proportional to their coming impacts.

There are many in parliament who are evangelical about technology and its ability to change lives. But surely, we have to ready citizens to take advantage of those opportunities through skills, flexibility and attitude. It is inevitable that there are huge potential changes coming, ones which will reshape our economy and our labour market. If these issues are not properly talked about, by preparing people to deal with them, we will be storing up tremendous problems for the future. We have to do much better.

This can all be reasonably predicted because it has happened before. The European Economic Community that Britain joined in 1973 was a very different beast to the EU we have part of since its expansion. Few people expected then that an economic union would also become a political one. Nor were most people aware or able to predict how fundamentally globalisation would reshape our economy and our communities. A lack of public consultation that forced through such massive changes had achieved a bipartisan consensus in Westminster. And it is this which brings us to the second existential issue for British politics: trust.

Those citizens who have borne the brunt of these radical changes feel ignored and patronised. Their security has been undermined and their way of life transformed. The years since the financial crash have been especially hard for many – to say nothing of the toxic cacophony of expenses scandals, dodgy dossiers, spin and the obscuring of hard choices. It seems to many that the system is now not only untrustworthy but also fundamentally rotten.

Against that backdrop, Brexit was an opportunity to restore that trust with a large section of society. By granting the referendum, our political class seemed to have recognised the need for a new democratic input – for some kind of check from the people of Britain on the consensus MPs had established. “The Government will implement what you decide,” said the booklet that dropped through every household letterbox, and many millions of voters believed it. Their decision was close but clear: Britain must leave the EU. The definition of that result was politically distilled, and the departure from the single market and the customs union has been cemented. In the general election of 2017, 85 per cent of people agreed.

Distrust and disengagement have now been replaced by curiosity. People hesitantly dared to hope that the political class was actually going to do something they requested.

Then along came Chequers. At a stroke, that emerging engagement with politics was dashed. Government spin proclaims that we are taking back control. The reality is that we are ceding it, at least on trade, in perpetuity. The document is a clever, legalistic, splitting-the-difference tome; the product of a process driven by a civil service never fully reconciled to leaving and, ultimately, not wanting to grasp the nettle.

Whatever we may think about the referendum, and whatever our own personal views on Chequers are, the key measure is one of trust. Does this proposal properly embody the decision of the British people in 2016? How is it sold to the disengaged or the exasperated? And, when this offer is salami-sliced away into irrelevance by the EU, what should the British people be told? That we gave it our best effort but came up short? That Brussels was right? That our political masters know best?

If Brexit directly leads to the jobs of truck drivers and call-centre workers being automated away without consultation or compensation, politicians here will not be forgiven. And if, after years of globalisation and European integration, MPs do not honour the pledge on which they hung their entire credibility, and implement the orders they had been given, politicians will lose the trust of the electorate for a generation.

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