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NICE’s recommendations for thromboembolism are not evidence based

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d6452 (Published 07 December 2011) Cite this as: BMJ 2011;343:d6452

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Re: NICE’s recommendations for thromboembolism are not evidence based

We were disappointed by Dr. Mark Welfare’s insinuation that Lifeblood: The Thrombosis Charity is controlled by big pharma and would like to clarify this and other misconceptions and inaccuracies contained in his personal view (1).

Lifeblood has always striven to be independent of the pharmaceutical companies. Our annual accounts ending on 31/1/11 filed at the Charity Commission, showed that 58% of our income is derived from public donations. We do receive funding from pharmaceutical companies, however we always ensure the funds are ring-fenced for educational / awareness projects. They are mainly directed towards our annual awareness campaign, “National Thrombosis Week”. Any pharma donations are only accepted on the basis that Lifeblood controls these projects. Similarly we do not endorse any products, and have taken a responsible stance with the new anticoagulants, advising they should only be used where there is an evidence base and there are licensed indications (see www.thrombosis-charity.org.uk).

It is true that in 2008 an errant journalist employed by an agency paid by Boehringer Ingelheim issued a press release timed to coincide with the launch one of the new oral anticoagulants. The article erroneously and irresponsibly suggested that Lifeblood endorsed the drug and hailed it as an alternative to warfarin. This was done without Lifeblood’s knowledge and consent. Furthermore Lifeblood reported Boehringer Ingelheim to the Prescription Medicines Code of Practice Authority for breaching the Code of Practice of the Association of the British Pharmaceutical Industry (ABPI), and the company was appropriately admonished.
(http://www.pmcpa.org.uk/files/sitecontent/annualreports/Annual_report_20... )

We have worked hard alongside health professionals and are proud to have shared responsibility for bringing the failure to prevent hospital-acquired venous thromboembolism (VTE) to the attention of the Health Select Committee in 2004, and to precipitate an enquiry. This, and continued lobbying from ourselves, health professionals and the All Party Parliamentary Thrombosis Group, led to the development of the Department of Health’s comprehensive approach which included new NICE guidelines (CG92) and the CQUIN VTE targets.

Dr. Welfare admitted he didn’t understand the basis of the figure of 25,000 preventable deaths due to hospital-acquired VTE. It may assist readers to know that it comes from data on file from the VITAE study, by Dr. A Cohen et al (2). This looked at six European countries and full country specific data were used in the UK calculations. It was a modified incidence based model, which took into account HES data, prophylaxis rates and published event rates. He found a conservative mortality figure for the UK was approximately 60,000 deaths and 42,000 being hospital related. Of these 20% might be terminally ill, leaving approximately 34,000 with survival prospects. Of these assuming a 50% recommended prophylaxis rate (medicine and surgery combined) and a two-thirds reduction in pulmonary embolism (PE mortality), then there are 25,000 deaths which are potentially preventable with prophylaxis. In support of this estimate, the last statistics on death in England and Wales where PE was mentioned on the death certificate were 16,670 in 2007 (National Statistics office). One of the problems with the death rate due to PE is that PE is grossly under-diagnosed. For example a post mortem study of hospital deaths in Cambridge showed that for every PE diagnosed in life, another two cases were not recognised antemortem (3). Thus applying this principle to the death rate in England and Wales, and allowing for the fact that a proportion of patients do receive thromboprophylaxis in hospital and therefore have their deaths prevented, would support the VITAE data.

Dr. Welfare argues we shouldn’t be using thromboprophylaxis in medical patients because there is no evidence it reduces death. He does concede there is a reduction in morbidity, i.e. in deep vein thrombosis but then criticizes the use of any surrogate marker. However the logic of using incidence of DVT (after all it is the usual cause of a PE) as a surrogate marker for PE cannot be denied. Furthermore reduction in morbidity, including post thrombotic syndrome, is of benefit to patients. Should health professionals only use medication if there is a proved reduction in death in clinical trials? Should we not also reduce suffering? Certainly the patient body we represent believes so.

Dr. Welfare suggests that “litigation costs will rise if patients who experience VTE after admission to hospital have not been given prophylaxis; and that Trusts will be fined …if they do not comply with the requirements to assess more than 90% of admissions”. Rather than supporting his argument for the removal of compulsory implementation of appropriate thromboprophylaxis, this makes a very cogent case for delivery of this important patient safety initiative. It is regrettable that Dr. Welfare feels that “there are many better things [he] could be concentrating on” and that Trusts who do not comply with the CQUIN target are losing money. However we note that his Trust finally achieved the CQUIN target of 90% for the first time in the second quarter of 2011-12, and so will not be losing money and we congratulate them on this.

Lastly Dr. Welfare suggests that the box for preventing VTE has been ticked and therefore “further research ideas will not be pursued, and political and clinical momentum will be lost”. However implementing the CQUIN targets has been difficult for many Trusts and has exposed issues that will stimulate more research. For example there is a lack of evidence for many groups of patients classed as “medical” and is thromboprophylaxis required in those wearing plaster casts? Moreover there is not yet a perfect pharmacological thromboprophylactic agent as he highlights.

On a more positive note, we thank Dr. Welfare for his support of the Lifeblood “Spot the Clots” Campaign. Again it may interest readers to know that far from being new, the campaign was conceived in 2010 and has been a main focus of the charity for a little short of two years. It is the product of numerous phone calls and e-mails to the charity by patients and relatives of those who have suffered or died of venous thromboembolism, where the diagnosis has been “missed” by health professionals.

Lifeblood is proud of its involvement in important patient safety initiatives, and this has been recognized by the Charity Awards with the “Healthcare and Research Charity of the Year” in 2010.

References
1. Welfare M. NICE’s recommendations for thromboembolism are not evidence based. BMJ 2011; 343: d6452

2. Data on file from: Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, Greer IA, Heit JA, Hutchinson JL, Kakkar AK, Mottier D, Oger E, Samama MM, Spannagl M; VTE Impact Assessment Group in Europe (VITAE). Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality.Thromb Haemost 2007 Oct;98(4):756-64.

3. Baglin TP, White K, Charles A. Fatal pulmonary embolism in hospitalised medical patients. J Clin Path 1997; 50 (7): 609-10.

Competing interests: Lifeblood: The Thrombosis Charity exists to increase awareness and improve management of thrombosis. Lifeblood has always striven to be independent of the pharmaceutical companies. Our annual accounts ending on 31/1/11 filed at the Charity Commission, showed that 58% of our income is derived from public donations. We do receive funding from pharmaceutical companies, however we always ensure the funds are ring-fenced for educational / awareness projects. They are mainly directed towards our annual awareness campaign, “National Thrombosis Week”. Any pharma donations are only accepted on the basis that Lifeblood controls these projects. Similarly we do not endorse any products, and have taken a responsible stance with the new anticoagulants, advising they should only be used where there is an evidence base and there are licensed indications.

15 December 2011
Annya Stephens-Boal
Executive Officer
Shelley Webster (Chair), Kim Carter , Ian M Franklin, Brian Gardner, Simon Hart, Beverley J Hunt, Simon Noble, Robin Offord,
Lifeblood: The Thrombosis Charity
PO Box 58, Llanwrda, SA19 0AD