Friday, January 06, 2012

Government delays kill over 500 accident victims

Our headline sets out the story which should be told. But, instead, we are reading that a drug used to treat wounded soldiers in Afghanistan "is to be fast-tracked for use in the NHS to help the victims of road traffic accidents and violent crime".

This is from the Independent - the only newspaper so far to carry this story in its current form, and getting it completely wrong.

As far as this newspaper is concerned, we have a "good news" story, where our beneficent government is reaching out to permit NHS paramedics to be issued with supplies of the drug Tranexamic Acid (TXA – marketed as Cykloapron or Cyklo-f), which has been successfully used by the British military to treat combat wounds from which "death is imminent".

Then, just so that we are aware how much we owe this wonderful government of ours, we are told that the drug "is the first to be approved under the Government's new 'medicines innovation scheme,' designed to speed up the adoption of promising medication for use in the NHS".

Given its potential, says the newspaper, "Andrew Lansley, the Health Secretary, intends to make TXA the first drug to be assessed under a new scheme to promote innovative uses for drugs outside their original authorisation. The scheme will be fully running by summer".

In fact, though, this is a distortion, giving an entirely false impression of the role (and powers) of the British government, and concealing a tale of bureaucracy and lethargy which, indirectly, has caused the death of hundreds of people.

In the first instance, Tranexamic Acid is not a new drug. It has been marketed in many EU countries under the trade name Cykloapron for more than four decades, for the treatment of haemorrhage or risk of haemorrhage. It was first authorised under Directive 2001/83/EC in August 1988, which permitted EU-wide use for authorised applications.

What is important here is that contrary to the impression given by the Independent, the British government is not in a position to approve new drugs. This has to be done under EU law, and it is the European Medicines Agency which is the final approval authority.

However, where Lansley has some scope for manoeuvre. EU law permits him to extend the use of "generic medicinal product of an originator product that has been in clinical use for over ten years". In other words, his "medicines innovation scheme" – which seems to have been reported for the first time only today – exists only because the EU allows it to.

The next crucial issue here – unsaid by the Independent - is that the trials for the current use started many years ago, with them having been reported by the BBC in November 2007 (below).

This was a major international trial, called "CRASH-2", carried out in 274 hospitals in 40 countries, investigating 20,211 adult trauma patients. And the final results were reported in the Lancet in June 2010 (many months after the completion of the studies), then reported by the BBC and even the Daily Mirror.

Helpfully, the Independent now tells us that in Britain, TXA could prevent about 280 of the 1,800 deaths that occur each year as a result of bleeding after injury.

But the studies which confirmed the effectiveness of the drug for this use were completed, done and dusted in the summer of 2010 - and interim results would have been known long before that. Yet, under the aegis of Mr Lansley, the drug will only be fully in use by the NHS, nation-wide by this coming summer – two years after its beneficial effects were clinically established (and long after it had been used for the purpose in Afghanistan).

By this reckoning, the two-year delay has caused the unnecessary deaths of well over 500 people, in part attributable to the previous Labour administration, but mainly to the Cleggeron administration which has perpetuated the lethargic bureaucracy which allows people to die in the thousands, for want of rapid drug approvals.

The costs and time taken to approve new drugs is, in fact, an international scandal, made far worse by the complications of EU law. In this case, though, even where the EU graciously permits our health secretaries some discretion, the bureaucracy still moves with glacial slowness.

An alert media would, of course, be asking why it has taken two years to get a well-proven and widely used drug into use in its new, life-saving role – holding the government to account as it claims to do. Instead, we get a leaden, misleading report from one newspaper. It lets the government off the hook, while the rest of the media is silent.

Thus are we (ill) served by the Fourth Estate.