Experimental blood clotting drug given to Brit troops in IRQ, AFG

[The Bread Guy]

Any chance any of our guys are getting this stuff?  Is this as much of an issue as the reporter makes it iout to be?

Shared in accordance with the "fair dealing" provisions, Section 29, of the Copyright Act - http://www.cb-cda.gc.ca/info/act-e.html#rid-33409

Experimental drug given to British troops in Iraq and Afghanistan
James Randerson, The Guardian (UK), 16 Sept 06
http://www.guardian.co.uk/frontpage/story/0,,1873961,00.html

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.

 

[CK]

I wouldnt call it experimental.  They have been using it for hemophillia for quite a while.  Novoseven is a recombinant Factor VIIa.  It's safe - Factor VII occurs naturally in every healthy persons blood.  When a vessel is damaged a cascade effect starts and the Factor VIIa in the blood, as well as other factors in the blood congregate to the site to begin the clotting and process.  See here: http://en.wikipedia.org/wiki/Factor_VII. 

The problems with it are that is needs to be refridgerated, and is still extremely expensive, though these issues are being address.

 

[The Bread Guy]

So it sounds like part of the issue is the litigious times we live in - if there's the potential for litigation, it'll happen,so let's not do ANYTHING (even if it might help) that might, even in a miniscule number of cases, may cause a problem.... :

 

[CK]

I dont think there is a problem with it.  I think it is that they are just starting to use it for trauma as opposed to it's traditional use for hemophillia.  There are strict steps that are required to be taken when implementing drugs for new uses.  I know DRDC has been looking into it's use for some time.  Temperature storage requirements are around 10 degrees Celcius, and the cost for one dose (administered IV) is very roughly $10,000 a shot.  Both issues are being addressed pushed by gov't funding, especially south of the border.  This has been an evolving issue for a number of years now, and is just slowly coming to the lime light; an indication that it is well on it's way to being fielded. 

 

[Donut]

Militaries have a long tradition of cutting edge research in trauma care, I see this as no different.

Keep in mind the CF has had several Health Canada special permits to administer experimental drugs, vaccines, or treatments in the past, and the medics in the sandbox are currently carrying IV fluids that my service is just rolling out as a clinical trial;  In fact, in the corner right now is a box of "mystery fluids" with all sorts of stickers and barcodes and labels on them (OK, it's either NS, HS, or HSD.  Not really mysterious, but kinda neat nonetheless)

Before the "randomized clinical trials" referred to in the Guardian article can occur, all sorts of OTHER clinical trials take place...then they administer it to real sick people, such as wounded squadies, and then we see if the stuff works....

That's called research! 

This shouldn't be called news.

 

[medicineman]

I can just see the headline now - "UK Military has hands on cool drug but won't use it" as the whole flip side to this issue.  The Brit media taught ours to find scandal where there wasn't any and to make mountains out of molehills and do it as incaccurately as possible.  I seem to recall from the TCCC working group I was with that Factor VIIA was at least being held  by us in Afghanistan, if not used if deemed necessary (at the Role 2-3, not as a front line agent to refrigeration needs).  I may be mistaken - I do remember us talking about it though.  MTF.

MM

 

[old medic]

http://www.mod.uk/DefenceInternet/DefenceNews/DefencePolicyAndBusiness/DefenceNewsDaily.htm

British Armed Forces treated with NovoSeven
There is extensive media coverage of the use of NovoSeven by the Defence Medical Services. NovoSeven is a licensed treatment for patients with bleeding disorders. It is very strictly controlled by the military, and only used for trauma patients when they have suffered catastrophic injuries and no other treatments are viable or available.

The drug has only been administered twice to military casualties since the Armed Forces began using it on operations, in two separate incidents in Iraq. The individuals’ lives were almost certainly saved by the treatment.

The use of NovoSeven was authorised after a very extensive review of the current evidence. We would not have authorised its use unless we were 100 per cent certain that the benefits would significantly outweigh any potential risks. Indeed, the NHS already recognises its benefits in treating severe trauma patients – and experts have advised us that UK hospitals have used the drug in similar circumstances.

 

[Sawbones]

This product (NovoSeven or Niastase) is held at all NATO Role 3 units in Afghanistan and surgical Role 2s.  It is at the R3 at KAF for use by the surgical team.  The US has used over 450 doses in OIF, I haven't heard of any CFHS cases yet, but we came close a few times this summer and it is there and eventually someone will need it.

To call this drug experimental in non-hemophiliacs is unfair - it actually had a successful trauma trial in Europe in non-hemophiliacs showing decreased need for transfusions and is now currently undergoing a major multicentre trauma rial in North America.  There was also a successful trial in people with hemorrhagic strokes. 

Current use in wounded is to use it if coagulopathy persists during and after surgery despite ad mistration of plasma, platelets( if any are available) and whole blood - usually after 10 units if there is no improvement. This is an "off-label" indication - the physician is using the drug outside of its initial approved indication - this is an accepted practice for many conditions - such as using aspirin in heart attacks - i.e. you won't find "heart attack - chew one tab" on your aspirin bottle - but you sure as hell are going to get it if the doctor thinks you are having the "big one".  Drug companies aren't always too excited about asking for new indications approval for drugs already being sold - especialy if physicians are already using it that way.  At least the manufacturer is funding these new studies, despite the fact the patent will soon run out.

The new trauma trials are trying to see if there is a better, earlier way to use NovoSeven, but they are unlikely to change the current way the drug is being used, just add more indications.

This news story is an example of someone with a little knowledge trying to make political hay, I doubt any experienced trauma surgeon or anesthesiologist would want to do combat surgery without NovoSeven/Niastase available.  The physician quoted in the news article was from an institute on tropical medicine and hygiene. Doubt he's seen as much blood loss in his career as some surgical teams see in a day.  'nuff said.

Sawbones