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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Britain's commemoration of Partition is colonial white-washing in disguise

It’s much easier to focus on the indigenous perpetrators of religious violence than on the imperialist policies that facilitated it.

While in London a couple of weeks ago, I couldn’t help but notice a curious trend in the British media’s coverage of the upcoming 70th anniversary of the end of British colonial rule in the Indian subcontinent. It wasn’t the familiar think-pieces about "the jewel in the crown", thinly disguised nostalgia for empire masquerading as critiques of colonialism (see for example, The Conversation’s piece on how colonialism was traumatic for, wait for it, officials of the British Raj). It wasn’t the patronising judgements on how India and Pakistan have fared 70 years down the road, betraying the paternalistic attitude some of the British commentariat still harbours towards the former "colonies". It wasn’t even the Daily Mail’s tone-deaf and frankly racist story about 92 year old countess June Bedani and her “loyal Indian houseman” Muthukanna Shamugam, who doesn’t even speak a word of “Indian” (that’s just classic Daily Mail). What got my attention was the British media’s raging hard-on for Partition - a flurry of features, documentaries and TV specials about one of the biggest and bloodiest mass migrations of the 20th century.

Just take a look at the major headlines from the past couple of weeks - "They Captured And Forced Him Out Of His Home: This Isn’t Syria In 2017, It Was India In 1947" (Huffington Post UK); "Partition: 70 Years On" (The Guardian, BBC and Independent, each with a different subhead); "The Real Bloody Legacy Of Partition" (The Spectator); "Remembering Partition: 70 Years Since India-Pakistan Divide" (Daily Mail) and many more. It isn’t that - unlike some of my more reactionary compatriots - I believe that the Partition story shouldn’t be documented and spoken about. On the contrary, I think India and Pakistan have failed to grapple successfully with Partition’s scars and still festering wounds, and the way it still haunts both our domestic politics and our relationship with each other. But the overwhelming focus on the grisly details of Partition by the British press is deeply problematic, especially in its unsubtle erasure of British culpability in the violence. Even the Guardian’s Yasmin Khan, in one of the few pieces that actually talks about the British role in Partition, characterises the British government as “naive and even callous” rather than criminally negligent, and at least indirectly responsible thanks to its politics of "divide and rule". Of course, it’s much easier to focus on the indigenous perpetrators of religious violence than on the imperialist policies that facilitated it. That would require the sort of national soul-searching that, even 70 years on, makes many British citizens deeply uncomfortable.

Rose-tinted views of empire aside, the coverage of Indian and Pakistani independence by the British press is also notable in its sheer volume. Perhaps, as some commentators have suggested, this is because at a time of geopolitical decline and economic uncertainty, even the tainted legacy of colonialism is a welcome reminder of the time when Britain was the world’s reigning superpower. There is certainly some truth to that statement. But I suspect the Brexit government’s fantasies of Empire 2.0 may also have something to do with the relentless focus on India. There is a growing sentiment that in view of historic and cultural ties, a post-Brexit Britain will find natural allies and trade partners in Commonwealth countries such as India.

If that’s the case, British policy-makers and commentators are in for a reality check. The truth is that, despite some simmering resentment about colonialism, most Indians today do not care about the UK. Just take a look at the contrast between the British and Indian coverage of Independence Day. While there are a handful of the customary pieces about the independence struggle, the Indian press is largely focused on the here-and-now: India’s economic potential, its relationships with the US and China, the growing threat of illiberalism and Hindu nationalism. There is nary a mention of contemporary Britain.

This is not to say that modern India is free of the influence - both good and bad - of colonialism. Many of the institutions of Indian democracy were established under the British colonial system, or heavily influenced by Britain’s parliamentary democracy. This is reflected both in independent India’s commitment (in theory, if not always in practice) to the ideals of Western liberalism and secularism, as well as its colonial attitude towards significant sections of its own population.

The shadow of Lord Macaulay, the Scottish legislator who spent four eventful years in India from 1834 to 1838 and is considered one of the key architects of the British Raj, still looms large over the modern Indian state. You can see it in the Penal Code that he drafted, inherited by both independent India and Pakistan. You can see it in Indian bureaucracy, which still functions as a paternalistic, colonial administrative service. And you can see it in the Indian Anglophile elite, the product of an English education system that Macaulay designed to produce a class of Indians “Indian in blood and colour, but English in taste, in opinions, in morals, and in intellect.” It was this class of Anglophile Indians who inherited the reins of the Indian state after independence. It is us - because I too am a Macaulayputra (Macaulay’s child), as the Hindu right likes to call us. We congratulate ourselves on our liberalism and modernity even as we benefit from a system that enriched the few by impoverishing the many. This class of brown sahibs is now the favourite punching bag of a Hindu nationalism that we have allowed to fester in our complacency.

Still, ghosts of the past aside, the UK no longer holds sway over young India, even those in the Anglophile upper classes. Today’s young Indians look to the United States for their pop culture references, their global aspirations and even their politics, both liberal and conservative (see the Hindutva fringe’s obsession with Donald Trump and the alt-right). We still want to study in British universities (though increasingly strict visa rules make it a less attractive destination), but we’d rather work in and emigrate to the US, Canada or Australia. We drink coffee rather than tea (well, except for the thoroughly Indianised chai), watch Veep rather than Yes Minister, and listen to rap, not grime.

Macaulayputra insults aside, the British aren’t even the bogeymen of resurgent Hindu nationalism - that dubious status goes to the Mughal Empire. Whether this cultural turn towards America is a result of the United States’ cultural hegemony and economic imperialism is a topic for another day, but the special "cultural links" between India and the UK aren’t as robust as many Brits would like to think. Which is perhaps why the UK government is so intent on celebrating 2017 as the UK-India year of Culture.

Many in the UK believe that Brexit will lead to closer trade links between the two countries, but much of that optimism is one-sided. Just 1.7 per cent of British exports go to India, and Britain's immigration policy continues to rankle. This April, India allowed a bilateral investment deal to lapse, despite the best efforts of UK negotiators. With the Indian economy continuing to grow, set to push the UK out of the world’s five largest economies by 2022, the balance of power has shifted. 

The British press - and certain politicians - may continue to harbour sepia-tinted ideas of the British Raj and the "special relationship" between the two countries, but India has moved on. After 70 years, perhaps the UK will finally realise that India is no longer "the jewel in its crown". 

 

Bhanuj Kappal is a freelance journalist based in Mumbai.