In Surrey England cases of Foot and Mouth Disease have been confirmed and once again the slaughter begins.
Reports confirm the virus as 01 British Field Strain 1967, a strain of the virus reportedly not present in the environment at the time of infection.

A short distance from these new outbreaks is the establishment at Pirbright where research into virus infections and the production of protective vaccines is carried out. Both the government-run and the pharmaceutical units on these premises have been reported to be processing Foot and Mouth Disease during the month of July and it is now considered that the disease began infecting the animals on the infected farm in the last days of that month.
To the surprise of many the UK organic movement is pressing the Government to introduce compulsory vaccination as a control measure, even though it is admitted that vaccinated animals may well have to be destroyed anyway because it is very difficult to determine vaccinated from infected animals. There is also concern that the genetically engineered strains used in the vaccines may not provide effective immunity to the "wild" virus types.
It is surprising therefore that "Organic farming" spokesmen call for the use of genetically engineered vaccines when their movement is theoretically opposing genetic engineering, especially in crops.

In the last outbreak of the disease in the UK there were also reports suggesting that the disease escaped from Government laboratories.
Click here for an article written about the 2001 tragedy

There are similar features to this latest outbreak with dead and infected carcasses being transported through disease-free areas in lorries with the potential to leak fluids and virus-contaminated air as they cross the main road links to the entire country. Television pictures show the lorries being loaded with the dead animals and although the sides of the lorries may be leak-proof the tarpaulins used to cover them cannot possibly provide the bio-security that is proclaimed to be a requirement in laboratories handling the dangerous virus.
Again, as with the 2001 outbreak, there has been a reluctance to close access to farmland by restrictions of access and public rights of way. Strangely given what has been known for decades about the vectors that are capable of transporting the virus it seems that the officials are unable to understand the basic risks.

We are informed that the only supplier of the vaccine for the control of the disease is the very firm now at the centre of the investigation into what is suggested to have been a deliberate release of the virus. Is this a case of an action that was done "accidentally on purpose"?
Perhaps the diligence of the farmer who spotted the signs of the disease in his animals and quickly reported to the authorities may have reduced the spread of the disease and the costs to the nation. Only time will tell if the release will cause as much damage as was caused in 2001.
We can only hope.

The following is an open letter written and supplied by Mrs Joanna Wheatley, an organic farmer who has worked for the chemical industry and who lives close to the infected area.

She writes -

To whom it may concern.

Reference current outbreak of Foot and Mouth (FMD)

Enclosed minutes of the 2006 meeting with the Veterinary Medicines directorate (UK)
My second question has direct relevance to this latest outbreak of FMD, which has been linked to a vaccine production unit near the farm. I have been concerned about veterinary medicines for a long time and the more information I received the more dangerous I perceived the situation to be. We may have traceability from "farm to fork" but when it comes to "from farm to pharmaceutical" it all falls apart. The majority of farmers and vets do not even realise the role of cattle materials used for these purposes.

As far back as 1995 I have been aware of problems with the licensing system. The first problem is that of the intellectually corrupt, in that the scientists who license the products also do the monitoring of adverse reactions and they also tend to be pharmaceutical company employees as well.

By licensing the government underwrites a product as fit for the market and so if a problem arises it is the government's fault. The producers can claim that they fulfilled all the criteria and so any problem is not their fault. So it is not in the licensing organisation's interest to find fault after licensing. Farmers have always had difficulty in proving problems, even when their own health has been affected, with OP sheep dipping being the most obvious. We do need meaningful surveillance and monitoring for problems.
All the veterinary preparations are concocted in the confines of laboratories, with workers being fully trained and protected in a very controlled environment. Once they are licensed they are unleashed into an uncontrollable environment. Farmers cannot control the weather or all the life cycles of invertebrates and vertebrates which are all inter-reacting all the time.

The government's only responsibility should be to monitor. The companies should seek underwriting from independent risk assessors, like insurance companies, or they could club together to form their own fund.
This would, I believe, make them act more responsibly.

Questions to be asked - Is the TB reactor test also produced at Pirbright?

The following represents the NOTES OF THE ANNUAL MEETING BETWEEN THE VETERINARY MEDICINES DIRECTORATE (VMD) AND CONSUMER REPRESENTATIVES HELD ON 9 JUNE 2006 AT DEFRA'S NOBEL HOUSE, LONDON.

Present:

Agenda Item 2.

Joanna Wheatley asked for information on the sourcing of pituitary extract hormones in use.

2. Steve Dean advised that there were four products available with marketing authorisations (MAs) that contained hormone active ingredients sourced from extracts of pituitary glands. Three of these were derived from porcine origin, one ovine. These products contained follicle stimulating hormones or lutenising hormones, or both in combination. He confirmed that all had been subject for a review for compliance with the joint guidance agreed by the Committee for Proprietary Medical Products (CPMP) and the Committee for Veterinary Medicinal Products (CVMP) entitled "Note for the Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human or Veterinary Medicinal Products." The products are authorised to be used predominantly in cattle for super-ovulation purposes. He confirmed that a veterinary surgeon would not be able to collect pituitaries from a slaughterhouse and that the sourcing of these hormone active ingredients was from countries like New Zealand where the country was currently free from reported cases of TSEs. John FitzGerald advised that further details were contained in the NOAH Compendium and the VMD eSPC website. The four products were available for use under a veterinary surgeon's control. These were predominantly used as an injection to prepare cattle for ovum transplantation. Joanna Wheatley asked whether standards were maintained for all cattle. Steve Dean confirmed the quality was consistent for all the target species.

Agenda Item 3.

Joanna Wheatley asked for information on bovine traceability for use in veterinary medicines and the checking of quality for contamination of TB, FMD etc.

3. Steve Dean repeated the fact that all Marketing Authorisation holders have to demonstrate compliance with the joint guidance from the Committee for Proprietary Medicinal Products (CPMP) and the Committee for Veterinary Medicinal Products (CVMP) entitled "Note for the Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human or Veterinary Medicinal Products." He confirmed that all products on the UK market were subject to thorough review to ensure that all risk materials of animal origin used in the production were fully compliant with the Notes for Guidance (NfG). For each product the Marketing Authorisation Holder had to determine whether the starting materials used were affected by the NfG. If so they were required to obtain the necessary information concerning the source, manufacture and control of the relevant starting material. The European Directorate for the Quality of Medicines (EDQM) reviewed starting materials used in veterinary and human medicines under this guidance and issued TSE certificates. In other cases the company could ask for work to be done at National Member State level. Generally, starting materials were certificated by the EDQM.

Steve Dean confirmed that the VMD kept a database of all products which included the TSE information relating to the manufacture of the product. For immunological products, this included information on the master and working seeds. He advised that companies kept a supply of the original stock which was called the master seed and would produce veterinary vaccines using a working seed. The information recorded for products included the type of material, supplier and whether or not an EDQM certificate had been issued. This would also include the source of the material and the country of origin. The VMD retained information on both the master and working seed. If the company was to lose the master seed then all the checks would have to be done again from the beginning. For example, if there was an outbreak of BSE or scrapie in New Zealand, which is currently BSE and scrapie free, then all derivatives of the medicinal products would have to be reassessed.

Joanna Wheatley said that using pituitary extract could lead to an immune system response. Steve Dean confirmed that there was always a risk in giving animal origin materials to animals. He advised that the guidelines showed how this risk has been minimised. He said the purpose was to bring the risk to its lowest level possible. If an outbreak should occur, the VMD had in place a system that would enable it to identify and suspend if necessary all medicines containing tissues derived from suspect cases. He advised Joanna Wheatley that she would need to refer to the Chief Veterinary Officer (CVO) of the countries concerned if she wanted further details on how the country controlled TSEs in its own stock.
He advised that there were a number of EU guidelines and general text in the European Pharmacopoeia that laid down the requirements for demonstrating absence of extraneous agents in veterinary immunological products.

For both live and inactivated products there was an extensive series of pre-authorisation and batch tests to ensure that the seed materials and starting materials of biological origin were free from extraneous agents. He advised that some testing would also be carried out by companies throughout the authorisation process. These tests results would go to a Qualified Person to sign off each stage and the validity of the results. These would be sent to the VMD to sign off as a batch release on the UK market. He confirmed that the Member State could re-test if it chose to. They could also sample the product when it was on the market. He advised that the surveillance on veterinary medicines has in the past picked-up extraneous agents occurring in veterinary vaccines and that the regulatory authority had the power to suspend manufacture at a production plant until it had been proven to be satisfactory.

Steve Dean urged Joanna to read the TSE guidance note that explained many of these processes in detail. He confirmed that Bovine derived active ingredients used in medicines for Bovine use was of high risk but this was accounted for in the guidance notes, such that the risk was reduced to a very low level.

4. A discussion followed regarding avian flu and vaccines grown on eggs. Steve Dean confirmed that the eggs would have been kept in a germ free environment using a viral filtration system. This was a tightly controlled environment to ensure that the vaccines were tested on contaminant free eggs.

Agenda item 4.

Colin Numan - The Soil Association asked whether the document on the VMD website listing all antibiotics used in human and veterinary medicines was kept up-to-date. He advised that the document would be more reliable as a reference document if it had a date on it. He said that the document listed Sarafloxacin as an antibiotic used in fish farming but the latest NOAH Compendium of data sheets no longer listed this as an antibiotic. He asked whether Sarafloxacin was currently licensed for use in fish farming and would the VMD date future revisions.

5. John FitzGerald confirmed that the UK was the first country to produce a list of human and veterinary medicine antimicrobials and how they were indicated for use. He advised that the date should have read 2002 which was when it was last updated and he confirmed that the VMD was looking to update this document later in the year. He advised that once completed it would go on to the website with a date but at this stage he could not advise on the final date. He confirmed that the Marketing Authorisation (MA) for Sarafloxacin expired in 2004 advising that there may still be stock left from batches produced before the MA expired. He agreed that this needed to be followed up and he would speak to NOAH on the issues that Coilin had raised.

Dated 7/8/2007

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