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


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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America’s domestic terrorists: why there’s no such thing as a “lone wolf”

After the latest attack on Planned Parenthood in Colorado Springs, America must confront the violence escalating at its heart.

First things first: let’s not pretend this is about life.

Three people have died and nine were injured on Friday in the latest attack on a women’s health clinic in the United States. Planned Parenthood in Colorado Springs was besieged by a gunman whose motives remain unclear, but right-to-lifers—who should really be called “forced birth advocates”—have already taken up their keyboards to defend his actions, claiming that women seeking an abortion, or doctors providing them, are never “innocent”. 

This was not unexpected. Abortion providers have been shot and killed before in the United States. The recent book Living in the Crosshairs by David S Cohen and Krysten Connon describes in sanguine detail the extent of domestic terrorism against women’s healthcare facilities, which is increasing as the American right-wing goes into meltdown over women’s continued insistence on having some measure of control over their own damn bodies. As Slate reports

In July, employees at a clinic in the Chicago suburb of Aurora, Illinois, reported an attempted arson. In August, firefighters found half a burning car at the construction site of a future clinic in New Orleans. On Sept. 4, a clinic in Pullman, Washington, was set ablaze at 3:30 a.m., and on Sept. 30, someone broke a window at a Thousand Oaks, California, clinic and threw a makeshift bomb inside.

The real horror here is not just that a forced-birth fanatic attacked a clinic, but that abortion providers across America are obliged to work as if they might, at any time, be attacked by forced-birth fanatics whose right to own a small arsenal of firearms is protected by Congress. 

The United States is bristling with heavily armed right-wingers who believe the law applies to everyone but them. This is the second act of domestic terrorism in America in a week. On Monday, racists shouting the n-word opened fire at a Black Lives Matter protest in Minneapolis, injuring three. This time, the killer is a white man in his 50s. Most American domestic terrorists are white men, which may explain why they are not treated as political agents, and instead dismissed as “lone wolves” and “madmen”.

Terrorism is violence against civilians in the service of ideology. By anyone’s sights, these killers are terrorists, and by the numbers, these terrorists pose substantially more of a threat to American citizens than foreign terrorism—but nobody is calling for background checks on white men, or for members of the republican party to wear ID tags. In America, like many other western nations, people only get to be “terrorists” when they are “outsiders” who go against the political consensus. And there is a significant political consensus behind this bigotry, including within Washington itself. That consensus plays out every time a Republican candidate or Fox news hatebot expresses sorrow for the victims of murder whilst supporting both the motives and the methods of the murderers. If that sounds extreme, let’s remind ourselves that the same politicians who declare that abortion is murder are also telling their constituents that any attempt to prevent them owning and using firearms is an attack on their human rights. 

Take Planned Parenthood. For months now, systematic attempts in Washington to defund the organisation have swamped the nation with anti-choice, anti-woman rhetoric. Donald Trump, the tangerine-tanned tycoon who has managed to become the frontrunner in the republican presidential race not in spite of his swivel-eyed, stage-managed, tub-thumping bigotry but because of it, recently called Planned Parenthood an “abortion factory” and demanded that it be stripped of all state support. Trump, in fact, held a pro-choice position not long ago, but like many US republicans, he is far smarter than he plays. Trump understands that what works for the American public right now, in an absence of real hope, is fanaticism. 

Donald Trump, like many republican candidates, is happy to play the anti-woman, anti-immigrant, racist fanatic in order to pander to white, fundamentalist Christian voters who just want to hear someone tell it like it is. Who just want to hear someone say that all Muslims should be made to wear ID cards, that Black protesters deserve to be “roughed up”, that water-boarding is acceptable even if it doesn’t work because “they deserve it”. Who just want something to believe in, and when the future is a terrifying blank space, the only voice that makes sense anymore is the ugly, violent whisper in the part of your heart that hates humanity, and goddamn but it’s a relief to hear someone speaking that way in a legitimate political forum. Otherwise you might be crazy.

American domestic terrorists are not “lone wolves”. They are entrepreneurial. They may work alone or in small groups, but they are merely the extreme expression of a political system in meltdown. Republican politicians are careful not to alienate voters who might think these shooters had the right idea when they condemn the violence, which they occasionally forget to do right away. In August, a homeless Hispanic man was allegedly beaten to a pulp by two Bostonians, one of whom told the police that he was inspired by Donald Trump’s call for the deportation of “illegals”. Trump responded to the incident by explaining that “people who are following me are very passionate. They love this country and they want this country to be great again.”

But that’s not even the real problem with Donald Trump. The real problem with Donald Trump is that he makes everyone standing just to the left of him look sane. All but one republican governor has declared that refugees from Syria are unwelcome in their states. Across the nation, red states are voting in laws preventing women from accessing abortion, contraception and reproductive healthcare. Earlier this year, as congressmen discussed defunding Planned Parenthood, 300 ‘pro-life’ protesters demonstrated outside the same Colorado clinic where three people died this weekend. On a daily basis, the women who seek treatment at the clinic are apparently forced to face down cohorts of shouting fanatics just to get in the door. To refuse any connection between these daily threats and the gunman who took the violence to its logical extreme is not merely illogical—it is dangerous.

If terrorism is the murder of civilians in the service of a political ideology, the United States is a nation in the grip of a wave of domestic terrorism. It cannot properly be named as such because its logic draws directly from the political consensus of the popular right. If the killers were not white American men, we would be able to call them what they are—and politicians might be obligated to come up with a response beyond “these things happen.”

These things don’t just “happen”. These things happen with escalating, terrifying frequency, and for a reason. The reason is that America is a nation descending into political chaos, unwilling to confront the violent bigotry at its heart, stoked to frenzy by politicians all too willing to feed the violence if it consolidates their own power. It is a political choice, and it demands a political response.

Laurie Penny is a contributing editor to the New Statesman. She is the author of five books, most recently Unspeakable Things.