MoD Experimental Drug use

[Two's in]

Be interested to see if any aircrew are being "offered" the chance to partake in another unlicensed drug trial courtesy of the MoD. What could posssibly go wrong?




http://www.guardian.co.uk/uklatest/story/0,,-6084216,00.html


Fears over drug for troops in Iraq
Press Association
Saturday September 16, 2006 7:18 AM


British soldiers in Iraq and Afghanistan are being treated with an experimental drug that has not been fully tested.

The Ministry of Defence is giving soldiers an experimental blood clotting drug called NovoSeven, the Guardian reports.

It says that because randomised controlled trials have not yet been carried out it is impossible to judge the drug's effectiveness. But the MoD said the drug has only been authorised after "an extensive review of the current evidence".

Liberal Democrat MP Phil Willis, chairman of the science and technology select committee, said the MoD's decision was "a dereliction of its duty of care that indicates a moral bankruptcy within the military." And an expert in trauma care has warned "there is potential for harm".

NovoSeven, which is also known as Recombinant Factor VIIa, 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.

Professor Ian Roberts, an expert in trauma care at the London School of Hygiene and Tropical Medicine, said: "Like all treatments there is potential for harm and it is not licensed for use."

Prof Roberts wrote to Defence Secretary Des Browne on August 8 to ask whether the MoD had approved the drug for use on British servicemen and women.

An MoD spokeswoman said: "The MoD attaches a high priority to medical research into trauma care. We are confident that we are offering the best possible care to our servicemen and women based on currently available evidence.

"The use of Recombinant Factor VIIa in 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 medical treatments have failed."

[ORAC]

And how, exactly, does this equate to the press campaign over Herceptin, where the papers hysterical pointed out that women might die of breast cancer, because Health Services would not prescribe it since it had not been being fully tested?

Obviously women are allowed to be guinea pigs, but servicemen are not. Best to just let them die.......

[QFIhawkman]

Sorry guys but what a load of rubbish has been posted above.

It's a drug to improve the blood clotting of haemophiliacs.

Has anyone any proof of the drug being administered (without choice) to British soldiers currently serving in Afghanistan or Iraq?
No? Well lets stop speculating then.

I can imagine it's in theatre. For quick use if someone fails to clot properly. I can imagine it's been offered to haemophiliacs.

But for god's sake let's stop speculating that it's the new "Anthrax". Nobody is being injected against their will.

[Postman Plod]

Hmmm cant help thinking that there is a slight difference between civil and military use for drugs such as this.... let me see.... what sort of injuries might someone be suffering from if they have to consider using this kind of drug?

Maybe its a life threatening one...? So what would they rather happen... use an untested drug and perhaps save a life, or let them die because you couldn't stop the bleeding? :ugh: :ugh:

"The use of Recombinant Factor VIIa in 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 medical treatments have failed."

[rusty_y2k2]

Sorry guys but what a load of rubbish has been posted above.

It's a drug to improve the blood clotting of haemophiliacs.

Has anyone any proof of the drug being administered (without choice) to British soldiers currently serving in Afghanistan or Iraq?
No? Well lets stop speculating then.

I can imagine it's in theatre. For quick use if someone fails to clot properly. I can imagine it's been offered to haemophiliacs.

But for god's sake let's stop speculating that it's the new "Anthrax". Nobody is being injected against their will.

Is haemophillia not a bar to service? I would have thought that would be right up there on the list!

[Almost_done]

I think a reply from the National Institute for Health and Clinical Excellence (NICE) would put all at ease. As they are the regulatory body for all drug trials etc.... They can be found here (http://www.nice.org.uk/).

[Two's in]

From a country that deemed Bermuda shorts and sunglasses to be adequate protection against witnessing nuclear explosions in the 50's/60's, fed a cocktail of Plague, Anthrax and NAPS pharmaceuticals to service folk during GW1, would not a modicum of caution be appropriate? If there is a high level of confidence in this drug, let someone in the MoD underwrite that confidence with the appropriate statement. Historically, servicemen and woman find out the non-licensed status of these drugs only when they begin to suffer the side effects. All the MoD need to do, if there is a risk, is to estimate it and publicise it, not leave it for some hapless victim to find the Government once again is abrogating its responsibilities. In this case, where there is an obvious use in theatre for a drug of this type, all the MoD need to do is formally announce the status and classification of this drug. But what about when the benefits of a drug a little harder to define, such as Plague and Anthrax in GW1? There is little evidence that the current Government is considering its Duty of Care responsibilities before the fact, would you trust your life to the Government to do the right thing?

[air pig]

The drug in question has been around for a couple of years. It used in the UK within the NHS on named patient basis, ie the drug is released from the manufacturer on consent from the patient or IF the prescribing doctor feels that it is in the patients best interests when consent is unavailable.

I have seen it used more than once for trying to stop a patient bleeding to death, when conventional therapy ( Surgery or rexploration and packing of a surgical site for a haemorrhage has been unsuccesful, and or when all other blood products have been tried and have failed to reduce blood loss) It is a drug not without risk to the patient but use is balanced against the risk to the patient of severe blood loss. Blood cannot be transfused continually, due to risks of transfusion reaction, kidney and lung failure, increasing problems with blood clotting or even infection. There is also the question of supplies within the area of operations as blood only has a finite shelf life even when refridgerated. The older the blood the less clotting factors available at the time of transfusion ie blood deteriorates when stored.

The use of this drug is NOT taken without due thought and consideration, but sometimes the benefit ouutweighs the risk to the patient. This drug can be a life saver in the correct situation.

The politicians should not say off the cuff remarks to newspapers until they have spoken to the doctors who have used the drug. This sort of, I believe ill informed comment from the Lib Dem spokesman, will only further increase the anxieties of the families of those deployed into action.

[BossEyed]

This blog post (http://www.blacktriangle.org/blog/?p=1451) will be of interest:
In fact, if the MoD had a policy of not supplying NovoSeven to UK troops, it would have been perfectly possible to run a story along the lines of
BRITISH GOVERNMENT DENIES POTENTIALLY LIFE SAVING DRUG TO OUR INJURED TROOPS.
The Ministry of Defence is refusing to supply a drug to prevent major bleeding to UK troops injured in Afghanistan and Iraq. The drug is already used by the US and Israeli military. The Ministry of Defence argues that the drug is too expensive considering the current lack of evidence for its benefits, even though major new trials are expected to show its usefulness in major trauma.

and:
UPDATE: The MoD has used the drug twice (http://news.bbc.co.uk/1/hi/uk/5351466.stm) in Iraq. Both soldiers lives were saved.

[air pig]

Heaven forbid that one of Mr Willis's relatives had a life threatening haemorrhage that was uncontrolled by normal means, would he deny them therapy which was in his terms 'experimental' or untested.

In the instances that I have seen it used the haemorrhage has reduced markedly and the patients involved recovered to leave hospital with their families, in an upright position, not in a BOX.

Would he deny a drug that has been used in NHS hosptials as a last resort, when all else has failed, and death is the likely outcome. I refer him to the question at the start of my post, when he can answer the question I may listen to him, not before. This MP should be campaigning for better medical facillities for UK armed forces, both as in patients and following discharge to their homes. As it is,they are disgusting !!! Maybe he should take a trip to Kabul and Khandahar for six weeks and see what the Services have to endure every day, and complain that a medical system that has to evacuate the seriously injured to Pakistan, because medical facillities are inadequte in the operational area to manage the very major trauma cases that are occuring.

Politicians--- Hate 'em :mad: :mad: :mad: :mad: :mad: :mad: :mad: :mad: