The drug that could save tens of thousands of lives - if only doctors could be told about it

The clotting drug tranexamic acid has already been included in the White House Medical Unit treatment protocols for President Obama. But until more people know about it, thousands of trauma victims all over the world will die needlessly without it.

Nothing could have saved President Lincoln. Kennedy might have survived the bullet in his back but not the one in his head. Garfield and McKinley, shot in the abdomen, died from massive internal bleeding. With four out of forty-four incumbents assassinated, and many more failed attempts, the job of US President is among the world’s more hazardous occupations.

However, the recent inclusion of the drug tranexamic acid into White House Medical Unit treatment protocols will increase the chance that Obama and future presidents will survive their terms. Being Commander in Chief means that presidential medical care is a military matter. The White House Medical Unit is in the White House Military Unit. Obama’s doctor is a Navy Captain.

In March 2010, results from the largest clinical trial ever conducted in trauma patients were reported in medical journal the Lancet. The CRASH-2 trial had randomly allocated over 20,200 bleeding victims of accidents or violence to receive either an injection of a drug called tranexamic acid or a matching placebo.1,2 Tranexamic acid had been used for decades to treat heavy monthly bleeding in women, but could it help in life threatening bleeding say from a knife in the ribs or bullet in the groin?

The results were spectacular. There were 160 fewer deaths in the tranexamic acid treated group. If given soon after injury, tranexamic acid reduced the risk of bleeding to death by about one third and without any side effects. Two weeks later, the British Army were using tranexamic acid to treat combat casualties in Afghanistan.

US military medics were not convinced. They had only recently burned their fingers on a new blood clotting drug called activated Factor VII. Seduced by industry hype and dubious expert advice, they had started using activated Factor VII to treat bleeding American soldiers even before results from randomised controlled trials were available. When the trials eventually reported they showed no evidence of benefit but significant side effects from unwanted clotting, with more heart attacks, strokes and gangrene.3 Lawyers smelled blood. And so even though there was a truckload of controlled trial evidence for tranexamic acid, they still wanted more data. The Taliban were more than happy to provide it.

Between January 2009 and December 2010, around 900 seriously wounded soldiers were treated by military medics at Camp Bastion in the Helmand province of Afghanistan. Improvised explosive devices had wreaked bloody havoc and double, triple, even quadruple amputees were not uncommon. One military surgeon described how he had worked on three soldiers wounded in the same explosion who had only two remaining testicles between them.

Of the 900 wounded, one third had been treated with tranexamic acid. Although the treated third were more severely injured than the untreated group, they were significantly less likely to die (17 per cent dead with tranexamic acid versus 25 per cent dead without). After statistical adjustment, the treatment benefit was even more dramatic.4 Although results from a randomised controlled trial with more than 20,000 participants should pack much greater scientific clout than the Helmand data, the experience of seeing a treatment effect in their own data was a powerful one and on 11 August 2011 US Tactical Combat Casualty Care Guidelines (pdf) were revised to include tranexamic acid.

A flag draped over a military coffin is politically inflammable. In large numbers, they can even smoke a president out of the White House. It takes the precise choreography of an Arlington funeral to get the corpse safely underground. Much less pomp and political risk surrounds the routine urban slaughter of young black Americans even though the number of deaths is considerably higher. A recent study estimated that the use of tranexamic acid to treat bleeding trauma patients in US hospitals could prevent more than 3,500 premature deaths each year.5 It was with these deaths in mind that the CRASH-2 investigators sent the entire clinical trial dataset to the US Food and Drug Administration (FDA) in March 2011 in the hope that the FDA would scrutinise the data and consider amending the licensing indications for tranexamic acid so that it could be marketed for use in trauma. Until this happens, any pharmaceutical company that promotes the use of tranexamic acid in trauma risks large fines.

Sadly, saving lives is not as easy as that. According to Dr Susan Shurin acting Director of the US Department of Health and Human Services, the FDA does not approve drugs unless the marketing company requests it and the marketing company will only request it if there is a demand. So we have a drug that could save a lot of lives if doctors knew about it but no one can tell them about it until it is licensed and it cannot be licensed until doctors know about it.

In an attempt to break this vicious circle, the trial investigators have had to take over the role of a pharmaceutical marketing department. Art students have been are enlisted to create informational cartoons that might go viral but might not.6 Doctors and university professors have had to lobby drug companies, to persuade them to take more interest in one of their own drugs, which is now generic and so not particularly profitable. If we do manage to raise the profile of this lifesaving treatment, the drug company will pay the FDA the license application fee, the FDA might give them permission to tell US doctors about tranexamic acid, the company will make some money and a few thousand Americans will not die.

It is absolutely right that those who risk their lives in the service of the President deserve the same standard of emergency medical care as the president. But so do the many tens of thousands of victims of violence and accidents who die needlessly every year around the world.

Ian Roberts is Professor of Epidemiology & Public Heath and Director of the WHO Centre for Injury and Violence Prevention at the London School of Hygiene & Tropical Medicine

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1CRASH-2 Collaborators. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010;376:23-32.

2The CRASH-2 collaborators. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. The Lancet 2011;377:1096-101.

3Levi M, Levy J, Andersen H, Trulof D. Safety of recombinant factor VII in randomized clinical trials.  N Engl J Med 2010;363:1791–1800.

4Morrison J, Dubose J, Rasmussen T, Midwinter M. Application of Tranexamic Acid in Trauma Emergency Resuscitation (MATTERs) Study. Arch Surg. 2012;147:113-119.

5Ker K, Kiriya J, Perel P, Edwards P, Shakur H, Roberts I. Avoidable mortality from giving tranexamic acid to bleeding trauma patients: an estimation based on WHO mortality data, a systematic literature review and data from the CRASH-2 trial. BMC Emergency Medicine 2012, 12:3 doi:10.1186/1471-227X-12-3

6The Lancet. CRASH-2 goes viral. The Lancet 2011;378:1758

 

The inclusion of tranexamic acid in White House treatment protocols will increase the chance that Obama and future presidents will survive their terms. Photo: Getty

Ian Roberts is Professor of Epidemiology & Public Heath at the London School of Hygiene & Tropical Medicine

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The investigation into Australia’s “Abu Ghraib” could neglect wider abuses in the Northern Territory

Footage from a youth detention centre in the Northern Territory capital, Darwin, may not be enough for authorities to finally address endemic discrimination in the region.

It isn’t Abu Ghraib, but you could be forgiven for making the mistake when you first see the picture of the hooded 17-year-old.

In shocking footage made available to the public for the first time on Monday night, guards at a juvenile detention centre in Darwin are seen apparently systematically abusing the teenager Dylan Voller in a horrific timelapse.

The Australian investigative series Four Corners aired CCTV footage showing guards body-slamming him to the ground, punching him in the head, violently stripping him naked, and pinning him to the ground in a hog-tie position.

It continues, piling atrocity on atrocity from when he was a 13-year-old detainee in 2010, until he is shown shackled to the chair in the already infamous photo from footage this year. It is understood that Voller has long been the object of special animosity from the guards.

Voller was not the only child suffering in the Don Dale facility over the years; tapes also showed six boys being tear-gassed in August of 2014. They had reportedly been kept in tiny isolation cells for 23 hours a day, some of them for weeks, though laws limited such confinement to 72 hours.

At the time, the press was told that there had been a riot at the prison in its maximum security cells but the newly-released footage shows a markedly different set of events. Guards had left one of the boy’s doors unlocked, and he slipped out of his cell and broke a window. Just as he appeared to be surrendering, guards took the decision to gas all six boys in the wing, five of whom were in their cells.

This situation would be shocking enough, but attitude shown by the guards – who laughed when the would-be escapee soiled himself, calling him unprintable names – has sent the whole country into an uproar.

Australia has a complicated justice system; it is technically governed by the Crown and it’s made up of both states and Territories. Policies shift wildly between them, and the Northern Territories are governed by what Australians call The Intervention, a series of paternalistic policies meant to cut back on crime and violence in Indigenous communities.

In 2007, then Prime Minister John Howard announced that pornography and alcohol would be banned for Aboriginal peoples in the Northern Territories, and welfare spending restricted by item.

Though only 3 per cent of the general population, Indigenous people make up 28 per cent of Australia’s incarcerated adult population, and 54 per cent of jailed youth nationwide. In the Northern Territories that youth number nearly doubles to 97 per cent

John Elferidge, who until yesterday was the NT Minister for Corrections, said that the trouble was due to a “lack of training”.  Adam Giles, the NT’s Chief Minister, has sacked Elferidge and personally taken over the portfolio, saying he was kept in the dark about these events Giles has pledged to appoint a permanent Inspector General for the Territory.

Prime Minister Malcolm Turnbull has called for a Royal Commission into the allegations of abuse and torture by prison workers, to be completed by early next year.

This is in itself controversial, because Turnbull has taken the decision to limit the Commission’s scope to the Don Dale facility alone – in the interest of speed and efficiency, he says – instead of investigating the whole of the Territory. Given that some of these guards have since transferred to other facilities, many people are concerned that this narrow investigation will fail to remedy the horrific problems.

Dylan Voller remains in isolation in an adult prison. Peter O’Brien, solicitor for both Voller and another of the boys, has called for his immediate release, saying that three of the guards from Don Dale are still in charge of his welfare.

It is unclear how much of this abuse is actionable. In most of Australia the statute of limitations to allege abuse by staff is three-six years. In the Northern Territories, it is a mere 28 days.

Linda Tirado is an author and activist who works in America, Australia, and the UK.