Submission to the Royal Society of Edinburgh FMD Enquiry by Dr Ruth Watkins BSc Hons, BFA Oxon, MBBS, MSc, MRCP, MRCPath

can be read in full here

Extracts

from Submission to the Royal Society of Edinburgh FMD Enquiry by Dr Ruth Watkins

 

It became apparent when I attended meetings that the vets and MAFF officials hardly knew any virology or principles of infectious disease control and vaccination and had not sought to inform themselves on FMD virus.

I was deferred to by the Welsh CVO at a public meeting at Builth Wells organised by the NFU and FUW at which I was a member of the audience and challenged the misleading untruths they were spouting on FMD vaccine from the platform. I also clarified a question on how the diagnosis of FMD was made that the panel could not answer. The NFU and FUW would not share a platform with me at any further meeting at which I was subsequently asked to speak in Wales. At only one of the meetings I spoke was an NFU man on the panel, at Penrith in Cumbria and I found myself having to defend him against furious animosity from the audience!

Do the DEFRA vets or the vets in the field know what they should read or to whom they should turn to inform themselves?

Are they even aware of or will they admit to their lack of knowledge? The most senior amongst them could have used the same sources as myself and then have passed information to the junior ranks but they did not do so.

During the early stages of the FMD epidemic Dr Noel Mowat offered to help educate MAFF officials and vets on FMD virology.

Dr Mowat used to work at Pirbright and ran courses on FMD infection at Pirbright.
His offer was refused.

On the 9th of March 2001, an offer of help came from the USDA collaborating with Tetracore to provide a sensitive real time PCR farmgate test

and if required an experienced team to carry out the work. It had been successfully laboratory tested by the USDA and required validation in the field.

Its convenient size, speed and simplicity of use was even demonstrated here on BBC television by Tetracore.

But Pirbright turned down the offer on the grounds of lack of time.

Seven months later Pirbright took the very same machine and started their own laboratory trials

Failing in the first instance to get good results, they went to press (The Veterinary Record 6 Oct 2001)* where they falsely claimed that Cepheid, the manufacturer of the PCR machine, had recommended and provided the wrong materials. Later in the same letter they triumphantly claim success by changing to those they would normally use - Cepheid do not provide or give advice on test materials.

What is going on at Pirbright?

Pirbright has confined itself to in-house tests, producing the materials and developing its own protocols.

It has refused to undertake validation of commercial FMD tests such as those produced by Michael Walker at Genesis. There is no other laboratory in Britain that is allowed or could undertake to validate FMD tests -

it is a breach of duty that this has been allowed to pass

. In clinical diagnostic laboratories it is well recognised that it is difficult to produce and quality control in-house tests. Commercial companies are rather better at this than most laboratories could sustain, particularly in the present climate as ever greater work efficiency is required.

The insistence on in-house tests and the refusal to share expertise and materials is typical of an institution guarding its research and exclusive status.

Is it hoping to suppress competition to its own tests? Does it stand to financially benefit? The interest of the clients is not best served, and 'service' is the operative word, by such attitudes.


Has Pirbright validated any tests during this epidemic that other laboratories can turn to and use when they have an outbreak of FMD in their own country?

Pirbright resolutely refused to entertain PCR as the routine method of diagnosis of FMD in animals during the epidemic claiming PCR was not validated.

They have been developing their own farm gate test for antigen (less sensitive than PCR especially in early infection) and continued developing laboratory based PCR, both in-house, during this FMD epidemic. They have not used either routinely to provide results during the epidemic.

They have also insisted that they could not use an anti-NSP test, as it also was not validated. Antibody to non-structural virus proteins (NSP) enables vaccinated herds or flocks to be distinguished from infected ones. Again they use their own in-house test rather than validate any commercial anti-NSP tests, also offered them during this epidemic from UBI for example.

How much further on is the World Reference Laboratory with the validation of modern scientific tests now? Other countries are using these tests such as Korea in the FMD outbreak it had in 2000. The OIE, by its constitution very conservative as all 150 countries must agree on tests and their validation to introduce any changes, has not recognised tests such as PCR and anti-NSP.

Has Pirbright validated any tests during this epidemic that other laboratories can turn to and use when they have an outbreak of FMD in their own country? Can it present any evidence for the validation of the PCR and anti-NSP tests to the OIE?

What is the function of a World Reference Laboratory, other than documenting different isolates from epidemics of FMD round the world, if not to advance the detection of virus infection and management of FMD epidemics?

The test results were sent to Page Street, MAFF headquarters, and persons who had never worked in a laboratory, who did not understand the principles of detection of virus, antigen or antibody, interpreted the tests results, according to a protocol sheet issued by Pirbright.

They will not show this protocol sheet to me. This must have led to mistakes.

Such a practice is not acceptable in medicine.

Combined with the fact that the results themselves were not given to the vets who went to the farms, nor to the farmers, but relayed by word of mouth, second, third and fourth hand . This constitutes poor clinical practice. In fact in many instances the local MAFF vet rang Page Street as they were constrained to do, to say the clinical diagnosis of FMD was uncertain or atypical.

They were not necessarily advised to take samples, but simply instructed to kill

.

If the index premise was not in fact infected with FMD, then it and all the 'dangerous' contacts and contiguous premises, and possibly all those for 3km about, were unnecessarily and wrongfully culled out.

When samples were taken and subsequent to the culling found to be negative, the index 'confirmed infected premise' has remained listed as such. This makes nonsense of virology. One might as well be back in medieval times, when the only possibility was clinical description.

Any farmer questioning the Page Street opinion or the diagnosis was brushed aside, unless they obtained the help of a solicitor.

Vets working for MAFF were also treated in a high handed fashion, and not allowed to exercise their own clinical judgement or to question that of any of the Page Street officials.

Persons expert in FMD from the UK, or in Europe and USA, outside DEFRA, Pirbright, or the Science Committee were not listened to.

Vaccination was unfairly vilified by the officials and by the NFU.

There was a complete lack of openness that is essential in my experience in dealing satisfactorily with outbreaks of infection. Panic and killing ruled all the days of the epidemic.

I would like to congratulate Dr Alex Donaldson on the timely and apt publishing of both the sequence of the VP1 gene of the epidemic strain and match with the Manisa type O vaccine and on the infectious characteristics of the epidemic strain of FMD, type O pan Asia, in pigs, cattle and sheep. Plumes of aerosolised FMD virus that could carry on the wind were thus not expected in our epidemic, unless large numbers of pigs were infected simultaneously which fortunately did not occur except at the Waugh's farm in Northumberland.

The Science Committee, the modellers and Page Street disregarded Dr Donaldson's work.

Also the modellers never published a 'normal vaccination' model at all - one where 100% of receptive domestic animals were vaccinated in a 2 or 3 Km ring about each infected premise without being killed afterwards.

Such a model could be called a 'biological model', not an economic or other non-scientifically constrained model.

It should be possible to use the best scientific methods of diagnosis and control of infection. Many changes need to be made so that this can be so in a future epidemic of FMD. Changes in OIE rules, European legislation particularly on vaccinated animals, but above all in our own Ministry and education of veterinarians in the understanding and use of vaccination. Vaccinated produce should be marketed quite normally without special treatment or labelling, as it is known to be safe.

None of the vets whom I spoke to, particularly the senior vets, understood the implications of control of the spread of an infectious disease by vaccination,

as Jenner foresaw the eventual eradication of smallpox in the 18th century using the less than perfect smallpox vaccine.

It seems easier and simpler to the veterinary profession to kill rather than to put into practice modern virology to control an epidemic* but as we have rediscovered this is not so nor is it acceptable when there is an effective vaccine.

Education on vaccination and virology is essential especially for vets and epidemiologists with responsibility for infection control.


VACCINATION

 

What roles do vaccination play?

41. Vaccination even with imperfect vaccines can achieve eradication of a virus from a population.

42. This is well known to the Imperial College modellers at least, who are authorities on modelling vaccination, yet they have never put this information into the public domain for FMD (e.g. vaccination of 100% animals receptive to FMD).

43. Both control of infection and eradication of virus can be modelled (without slaughtering vaccinated animals).

44. A balanced portrayal of the role of vaccination should be available for the public domain and sent out to farmers.


Submission to the Royal Society of Edinburgh FMD Enquiry by Dr Ruth Watkins BSc Hons, BFA Oxon, MBBS, MSc, MRCP, MRCPath can be read in full here