.Experimental drug given to British troops in Iraq and Afghanistan
Soldiers in Afghanistan and Iraq are being treated with an experimental blood-clotting drug that has not been fully tested.
Because randomised controlled trials have not yet been carried out into the drug's effectiveness, it is impossible to know whether it is doing more harm than good to patients.
Veterans' support groups have criticised the Ministry of Defence action. One trauma expert has said soldiers treated with the drug could sue the MoD if trials produce evidence it is harmful.
Phil Willis, the Liberal Democrat MP who is chairman of the science and technology select committee, described the MoD's decision as "a dereliction of its duty of care that indicates a moral bankruptcy within the military".
The drug, called NovoSeven, was originally licensed in 1999 as a treatment to stem bleeding in haemophiliacs.
It is undergoing trials for use to stop bleeding in trauma patients with severe wounds and bleeding within the brains of patients with severe head injuries. But its effectiveness and safety as a blood-clotting agent in these circumstances has not been proven.
Inquiries by the Guardian have established that the MoD has authorised its use in battlefield trauma casualties.
Ian Roberts, an expert in trauma care at the London School of Hygiene and Tropical Medicine, said: "The point is that it is hugely expensive. Like all treatments there is potential for harm and it is not licensed for use."
Professor Roberts wrote to the defence secretary, Des Browne, on August 8 to ask whether the MoD had approved NovoSeven - also called Recombinant Factor VIIa - for use on British servicemen and women. It is thought that the US and Israeli militaries are also using the drug.
"My concern is that the MoD may be wasting resources on expensive treatments that may do more harm than good when it could be investing in high quality research that has the potential to improve the care of combat casualties world-wide," he wrote.
Prof Roberts has not received a reply, but the MoD confirmed to the Guardian that the drug was being used in trauma patients injured on the battlefield.
Veterans' support groups were dismayed. "It seems to us wrong that the military would almost use soldiers as guinea pigs for drugs that have yet to have a proven safety record," said Andrew Burgin of Military Families Against the War, a group with 600 members.
Michael Shalmi, a scientist at Novo Nordisk, the Danish company that manufactures the drug, said: "It is far too early to say whether the benefits of NovoSeven in [the head trauma] context outweigh the risk on a definitive basis." He said a single dose of the drug would cost between £750 and £3,000 depending on the size, and confirmed that data from the drug's use by the MoD and US Department of Defence would not be fed into the company's randomised controlled trials of the drug.
In its response to the Guardian, the MoD said: "Use of Recombinant Factor VIIa in by the defence medical services (DMS) has been authorised after an extensive review of the current evidence. It is strictly controlled in the DMS and only authorised when conventional resuscitation measures have failed."
But Prof Roberts said that even the severely injured should not be given an experimental treatment. "Just because someone's at a high risk of death, it doesn't mean the treatment can't increase their risk of death." In his letter, he said the MoD might be open to legal challenges if clinical trials subsequently find the drug is harmful to trauma patients. But the MoD denies it is putting personnel at risk.
Martin Shalley, president of the British Association for Emergency Medicine, said it was not unprecedented for drugs to be used "off label," in situations where they have not been fully tested. Doctors sometimes had to take a pragmatic approach.
Neither Novo Nordisk nor the MoD could confirm how many patients have been treated with NovoSeven.
Guardian
Because randomised controlled trials have not yet been carried out into the drug's effectiveness, it is impossible to know whether it is doing more harm than good to patients.
Veterans' support groups have criticised the Ministry of Defence action. One trauma expert has said soldiers treated with the drug could sue the MoD if trials produce evidence it is harmful.
Phil Willis, the Liberal Democrat MP who is chairman of the science and technology select committee, described the MoD's decision as "a dereliction of its duty of care that indicates a moral bankruptcy within the military".
The drug, called NovoSeven, was originally licensed in 1999 as a treatment to stem bleeding in haemophiliacs.
It is undergoing trials for use to stop bleeding in trauma patients with severe wounds and bleeding within the brains of patients with severe head injuries. But its effectiveness and safety as a blood-clotting agent in these circumstances has not been proven.
Inquiries by the Guardian have established that the MoD has authorised its use in battlefield trauma casualties.
Ian Roberts, an expert in trauma care at the London School of Hygiene and Tropical Medicine, said: "The point is that it is hugely expensive. Like all treatments there is potential for harm and it is not licensed for use."
Professor Roberts wrote to the defence secretary, Des Browne, on August 8 to ask whether the MoD had approved NovoSeven - also called Recombinant Factor VIIa - for use on British servicemen and women. It is thought that the US and Israeli militaries are also using the drug.
"My concern is that the MoD may be wasting resources on expensive treatments that may do more harm than good when it could be investing in high quality research that has the potential to improve the care of combat casualties world-wide," he wrote.
Prof Roberts has not received a reply, but the MoD confirmed to the Guardian that the drug was being used in trauma patients injured on the battlefield.
Veterans' support groups were dismayed. "It seems to us wrong that the military would almost use soldiers as guinea pigs for drugs that have yet to have a proven safety record," said Andrew Burgin of Military Families Against the War, a group with 600 members.
Michael Shalmi, a scientist at Novo Nordisk, the Danish company that manufactures the drug, said: "It is far too early to say whether the benefits of NovoSeven in [the head trauma] context outweigh the risk on a definitive basis." He said a single dose of the drug would cost between £750 and £3,000 depending on the size, and confirmed that data from the drug's use by the MoD and US Department of Defence would not be fed into the company's randomised controlled trials of the drug.
In its response to the Guardian, the MoD said: "Use of Recombinant Factor VIIa in by the defence medical services (DMS) has been authorised after an extensive review of the current evidence. It is strictly controlled in the DMS and only authorised when conventional resuscitation measures have failed."
But Prof Roberts said that even the severely injured should not be given an experimental treatment. "Just because someone's at a high risk of death, it doesn't mean the treatment can't increase their risk of death." In his letter, he said the MoD might be open to legal challenges if clinical trials subsequently find the drug is harmful to trauma patients. But the MoD denies it is putting personnel at risk.
Martin Shalley, president of the British Association for Emergency Medicine, said it was not unprecedented for drugs to be used "off label," in situations where they have not been fully tested. Doctors sometimes had to take a pragmatic approach.
Neither Novo Nordisk nor the MoD could confirm how many patients have been treated with NovoSeven.
Guardian
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