Sunday, June 25, 2006

Another £1 million. Who's counting?

While farmers are struggling with herd tb restrictions and undervalued pedigree cattle (see post below) there appears to be no shortage of the readies in the research field. Dr. Cheeseman of badger heaven, overwise known as Woodchester Park, has been awarded £1million to explore badger vaccination. This involves trapping around 250 badgers, transporting to a laboratory and vaccinating them and "could lead to more than 100, 000 badgers being vaccinated nationwide" has a good piece on this little publicised work culled from the ever vigilant
ProMed .. The moderator's comments are, as usual, well worth reading in full. Extract :
"...The Randomised Badger Culling Trials demonstrated that if you do not achieve culling targets above 60 percent (and sometimes these were no more than 20 percent), you will only make matters worse -- Bovine TB was practically eradicated in the UK by 1986 by proactive badger culling along with tuberculin testing of cattle when only 84 herd breakdowns were recorded in that year. ...... as the UK Government acknowledges in their report of 2004, if the present policy of inaction continues there is no way but up!....... Culling, when done efficiently, i.e. when delineated areas are free of badgers for at least 12 months, has an immediate disease control benefit. In the UK there is a stark dichotomy between the demands for culling by the farming community, including wildlife veterinarians, and the extreme reluctance on the part of the government. We have yet to see what the impact of badger vaccination will be. - Mod.MHJ" wonders " However good this news may seem, we are left once again wondering why - if the trials are successful and the vaccine found to be safe and effective - it has to "take at least 5 years before the vaccine could be administered to the general badger population outside the lab through microcapsules mixed with peanuts."

Parliamentary Questions explored some of these questions and received the following answer;

23rd March 2004: Col 686W.

"Under European legislation marketing authorisations for veterinary medicinal products, including vaccines, may only be granted where scientific assessment of data supplied by the applicant demonstrates that the product meets statutory criteria of safety, quality and efficacy. The fee currently charged by the Veterinary Medicines Directorate (VMD) for processing an application for a UK marketing authorisation is between £1,480 and £21,210, depending on the type of application and application and the complexity of the assessment required. The fee for a novel veterinary vaccine, such as a TB vaccine is likely to be at the upper end of the scale.
European legislation requires applications for new markewting authorisations for veterinary medicinal products to be processed within 210 'clock' days of submission of a valid application. 'Clock days' are calendar days,including weekends and holidays, but excluding any period where further information is requested and awaited from the applicant. [..]
Typically, the total time taken to determine an application for a marketing authorisation for a novel medicine, such as a TB vaccine, could be approximately two years.

European legislation permits provisional marketing authorisations to be granted, in exceptional, objective and verifiable circumstances, without the need for a full data dossier. Such authorisations are only granted where safety has been established and are subject to specific conditions, such as carrying out of further studies for efficacy."

Any progress on damping down the badger / cattle interface is to be welcomed. However, we also note from PQ's March 22 2004, Col 510W, that "M.bovis is endemic in British badgers".

What therefore would be the result of 'vaccinating' an animal already infected with the disease?And if the vaccine were transferred to peanuts, what would be the effect of other species ingesting a not-very-accurate dose? In fact, as badgers are agressive eaters of most things, what would be the result of a single alpha male, scoffing all the laced peanuts on behalf of his tribe? And how practical is 'trapping and injecting' on a wider field scale?

Finally, although this research gives valued employment for Dr. Cheeseman et al , given the parliamentary answer quoted above re vaccines, plus the cost of drug registration, how viable would this product be to pharmaceutical companies? They usually trade worldwide, but this vaccine's use would probably be limited to the UK and Ireland. ( possibly as a single dose jab)

No comments from us here; just pondering.

Defra challenged over Tabular valuations.

A challenge to Defra's tabular valuations has been launched by West country law firm, Clarke Wilmot. The case has been brought on behalf of Devon dairy farmer, Graham Partridge who has 300 pedigree dairy cattle on his farm near Tiverton and who feels they are seriously undervalued by the new system.

Introduced in February, the tables cover 'average market value' of various class of livestock. Male or female, beef or dairy, an age banding and crucially, 'pedigree or non pedigree'. Thus an aged pedigree jersey cow would be 'valued' at the same rate as a young holstein in her prime. Conversely a old Dexter bull with minimal influence on beef values, would rate the same as a Perth show winning Charolais or Limousin. 'Market value' is exactly what it says. The price of that class of animal traded in the local livestock market, in the previous time frame. And therein lies the problem. Animals of high genetic merit are rarely traded in that marketplace. And on farm dispersals, breed 'showcase' sales and private sales are excluded from Defra's tables.

Little Ben, our remaining Minister is quoting - or misquoting - his two reports into cattle compensation, both of which concluded that the majority of valuations were OK. Reading was the first, the most recent Exeter, who followed Reading's format so as not to tread on any professional toes. Exeter found that 80 percent of the valuations were 'in line', and that, said the author, was "as good as it gets" on the scale that these compensation payments were made. (We think he meant there were a lot) He went on the describe as many 'under valuations' as over, with just one or two very high profile over payments, making headlines.

Mr. Partridge feels that Defra's valuation tables do not reflect the true value of his stock, and his lawyers will now use this case to bring a judicial review of the controversial new system.

In an ideal world, this situation should not have arisen at all, with farmers able to insure for any value above 'average' that they felt their stock merited. In fact a couple of years ago, our own Rear Admiral Ben, gave the following answer to just such a parliamentary question:

15th Dec 2003: Col 629W
Mr. Paterson.
To ask the Secretary of State for Environment, Food and Rural Affairs whether farmers are able to obtain insurance cover for TB infection in dairy cattle after a TB breakdown and subsequent claim. [141083]

It is government policy to pay compensation at 100 per cent of market value, with no upper limit, for cattle that are compulsorily slaughtered under TB control measures. Farmers therefore do not need to take out insurance on their animals. Theoretically, insurance can be bought to cover other consequential losses for which compensation is not paid, but that is a commercial matter between farmers and their insurers.
Section 34 (5) of the animal Health Act 1981, explicitly allows insurers to deduct the amount of Government compensation from the value of any payout they may make.

Insurance companies will make their own decisions on whether to insure, and about the size of the premiums, based on their assessment of risk.

Recent contact with the insurance industry in early 2003 indicated that, although companies were honouring existing policies, they are not offering new policies to cover TB in cattle herds, particularly in areas where TB is increasingly prevalent. This is because farmers do not wish to take cover in areas where the risk is low (such as Yorkshire) but do wish to purchase cover in areas of high incidence (such as the South West) However, the insurance companies consider that the financial risks in offering insurance policies in areas of high incidence are too high at present.

Quite explicit isn't it? Farmers need not take out insurance. Defra will pay 100 of valuation, but even if they wanted too insure, exposure to risk is likely to be too high for them to get cover. Last year, the cost of tb cover increased tenfold, and cover halved. That's if you were lucky enough to still have a policy in place, and not been unlucky enough to have made a claim.

Wednesday, June 21, 2006

The survivor.

After an (almost) complete cull of ministerial staff in Defra recently, only our own little Ben, Rear Admiral Bradshaw survived. Years ago he reportedly told enquirers that his policy for bTb was "not to be in the hot seat when action needed to be taken". Well folks, he's still there. He's cogitated, created committees and stakeholder groups, and most recently asked for a public consultation on culling badgers. One may ask of the latter, why? as the responsibility for control of a grade 3 pathogenic zoonosis is wholly and completely - Defra's.

As government sneak through a fast track method of what is euthemistically called 'ventilation shut down', in the event of bird flu striking intensove flocks of chooks, we cull from from, comments with which we fully agree on the bTb situation still facing the single surviving minister of Defra's old team:

"When Ben Bradshaw, with no apparent understanding of the undertow of his words, proclaimed last week, in relation to the killing of badgers:
"My Department undertook a desk study of possible culling methods and identified shooting, snaring and gassing as the methods most worthy of further investigation. This research is currently under way. .."one wonders, and not for the first time, about the methods and ethics of the sort of research needed to decide on ways of mass killing. We wonder too, as we did in April, why animal health policy always seems to be driven by politics, bureaucracy and budgets instead of by science, technology and veterinary skill. No one really wants an untargetted mass cull of badgers and the Government, surely, has within its grasp a Middle Way. The tools to avoid such a politically unpopular, ethically questionable and scientifically unnecessary move are documented. The research below using UK built rapid RT-PCR diagnosis in badger setts and latrines shows which badgers are infected;
"we would prefer that culling is targeted at diseased and infectious animals" said the researchers.Have Mr Bradshaw and "his Department" really not seen the importance of the work from Warwick University?"

As we have said many times, every PCR magic box negates the need for a couple of 'government scientists', so why would they agree? Perhaps ventilation shut down (VSD might be a better way out for them (the scientists, not the badgers or the chooks) Up to 60 minutes to suffocate. Nice.

Sunday, June 11, 2006

"Time for a Veterinary concensus"

A letter in this weeks' Vet. Record calls for a concerted and joined up effort on the part of the veterinary profession, to eradicate bTb from any sources which harbour it.

In his letter Bovine TB policy and badgers " A joint and co-operative approach" is needed :
Mr. Swarbrick wrote:
"...... Like many others, Bourne and colleagues appear to be ignoring several important factors and offering no real solutions. Over 25 years there does not appear to have been any concerted national action to control, let alone eradicate, the relentless spread of bovine TB. We have an EU obligation to eradicate bovine TB. Given that there are no vaccines, prophylaxis or therapy for bovine TB, we can only adopt the long-established medical and veterinary principles for infectious disease control by removing all infected, and more especially diseased, individuals from any contact with healthy populations............. We need a veterinary consensus as to what to do and how to do it, and veterinarians must also find consensus with the ecologists, who have an important contribution. ...... We also need to persuade the pro-badger lobby that some of their comments are incorrect. Time is not on our side and veterinarians, farmers and the UK as a whole cannot allow the perceived difficulties to be an excuse for inaction. Will the ISG please now put forward its strategy and protocols for the eradication of bovine TB from the UK and also for preventing diseased badgers from infecting cattle, badgers and all the other animals, bearing in mind that there is a potentially important human dimension." Read in full

(With thanks to )

Friday, June 09, 2006

"Krebs was a pseudo-scientific charade.."

Ever vigilant, Muckspreader (Private Eye) has been reading the veterinary comments emerging from the Krebs trial and concludes that the RBCT was never designed to work at all:

"Even Defra admits that the percentage of badgers culled was sometimes as low as 20 percent. Prof.Bourne has admitted in the Veterinary Record that his staff were not allowed into a third of the land chosen for study. Meanwhile the tragedy rolls on: for farmers, for cattle, for taxpayers, and for all those sick badgers, condemned to a lingering death, only because humans became so blinded by sentimentality that they allowed badger numbers to explode to a level nature could no longer tolerate.."

And from a landowner who also happens to be a member of the RCVS, yet another damning indictment of skewed 'science'.

"As a landowner in one of the 'trial' areas, I had the dubious pleasure of being invited and attending Professor Bourne's meeting to explain the aims and implementation of the Krebs trial to landowners. (Mmm, us too. Good weren't they?)
His presentation was fluent, forceful and full of spin. During the presentation, he pontificated on some events in the history of badger / bovine TB in Dorset. Unbeknown to him, these were events that I had been personally involved with and knew full details of.
It was very educational to me.

I realised that he was describing the facts in a strictly accurate - yet totally misleading - way, so the impression given was the opposite to the truth."

(Well there's a surprise - doesn't he always? - ed) The letter continues:

" That the trial is severely flawed - in my opinion, fatally so - is self evident to any objective scientist. A sound experiment, for that is what the 'trial' purported to be, depends on knowledge of, and control of, all the variables. This trial had no control.

In the 'proactive' areas no culling took place during the lactating periods, and 20 percent of the babgers were left behind. (In our patch we reckon it was more like 80 percent left behind - ed) It would seem that there was, effectively, not a great deal of difference between proactive and reactive areas." (Err there was. At least in the proactive, eventually the Wildlife teams actually turned up. In some of the reactive areas, not a sign. Sick badgers and dead cattle, but no diminutive professors with cage traps. But we digress - the writer explains further:)

"When one allows for the unofficial culling that took place in the no treatment areas, these results are skewed. No matter how the statistics are applied (we prefer 'tortured' - ed) the conclusions drawn can be challenged by a competent sixth former.

Over the past 25 years or more, many veterinary officers have diligently collected masses of data on thousands of breakdowns, and have had their work scrutinised by a sceptical mini panel. All that work, together with that of the veterinary investigation officers, has been effectively been ignored by both Krebs and Bourne. The results of the inquiry and the trial appear to have more to do with egos of eminent men, than science or truth. Bourne's insulting personal response to the points raised by Paul Caruana is no less than I expected from this most arrogant of men."

That broadside, with which we fully agree, was launched by John Cohen, BVetMed, MRCVS of Chard, Somerset, and printed in Veterinary Times, June 12th.

More on the RBCT. A vet's view.

In response to letters to the veterinary press by Professor John Bourne, defending (or trying to) the badger 'culling' trial carried out by his ISG group, Worcestershire veterinary surgeon, Jessica Thornton, MRCVS weighs in with a robust critique in this week's Veterinary Times:

"The "results" of the Randomized Badger Culling Trial (RBCT) have been continously upheld and used by the ISG, Badger Trust and RSPCA to sway political and public opinion against a badger cull. It's unbelievable that Prof. Bourne is so blinkered by his scientific tunnel-vision that he has no capacity to see the blatant weaknesses of the RBCT.

He is not only insistent about denying the faults of the trial, but he denigrates fellow scientists and insults veterinarians who have worked on the frontlines of the bTB battle for years, in some cases decades."
Ms. Thornton then makes the following points:

* "The trial may have been rigorously implemented, but it was not well implemented.

*Sixty-nine percent of traps were interfered with - 57% had interference while 12% went missing (Parliamentary Questions 8, December 2003, column 218W [141971]).

* Treatment groups were not treated similarly. For example, in the reactive groups 36% of TB breakdown notifications received no culling while the remainder received partial or full culling.

*Foot & Mouth Disease (FMD) disrupted culling in proactive areas, which were supposed to be culled every 5-9 months.

* Only 2 proactive areas were culled in this time frame, while the other 8 areas ranged from 12-25 months between intitial and first culls.

*Several proactive areas' follow-up culls resulted in more badgers being culled than in the intial cull. Was this due to inadequate culling to begin with? Interference with badger traps? A long delay between culls?

It is safe to say that culling of badgers in the RBCT was a failure, and so the very aim of the study was missed. It doesn't matter how "robust" statistical analyses are or what world renown magazines published the study. There is no way that such a large amount of interference and variation within treatment groups could result in a reliable outcome.

Perhaps this 'peturbation' effect is actually the reuslt of inefficient badger culling, and not localised badger culling.

Another concern raised is this issue of peer review. A peer reveiw is scrutiny of a scientific paper by an independent, anonymous specialist. As Deputy Chair of the ISG, Prof. Donnelly would not be eligible to peer review the ISG's report, as he is neither an independent nor anonymous specialist. After putting so much time and effort into the RBCT, it would be very difficult for any member of the ISG to be unbiased enough to peer review the report.

In addition, I am confused as to which "past, failed TB control policies" Prof. Bourne is refering to in his May 13th letter to the Veterinary Record, and May 22nd to the Vet. Times. History shows that the 1950's TB outbreak was controlled using the tuberculin skin test and mandatory slaughter of reactors. Present day success in the other EU states have successfully reduced/eradicated bTB with the same method.

Prof. Bourne then argues that cattle-based TB control measures need to be more vigorously adopted and applied. One main difference between then and now is the large wildlife population acting as a bTB resevoir (namely badgers, but also deer and other mammals). Cattle-based controls alone will not reduce TB incidence in cattle when there is a high disease incidence in a wildlife reservoir population.

The disease in the wildlife resevoir must be reduced as well. If it is clear that badgers contribute to TB in cattle, then what does the ISG propose we do about this wildlife bTB reservoir? Ignore it? That's a great plan. Or why don't we waste another decade and £millions in taxpayer's money to set up another scientific research trial to determine the effects of ignoring bTb in the wildlife reservoir?
(don't give them ideas Ms. Thornton - ed)

Unfortunately, the RBCT has not made the "extent to which badger culling can be reduce TB incidence in cattle" any clearer. The fact is, the longer we stand by jostling between ourselves, the worse the TB situation is getting for everyone involved, badgers included!

It would be disheartening for anyone who has worked on the RBCT to admit that circumstances within and outside their control have resulted in no conclusive evidence in regards to badger culling and its effects on bTB in cattle. Perhaps working so closely to the project has made it difficult for some to see the trial's weaknesses, making any criticism personally offensive.

However, as men and women of science we must be responsible and mature enough to be self-critical of our own work and to consider humbly the criticism given by our peers. Otherwise our "scientific results" may wrongly influence those unable to deterimine whether science is good or bad, as well as take advantage of the faith they place in science and scientists alike. "

Tuesday, June 06, 2006

"What do I know - I'm only a vet...."

Two letters in the Veterinary Times (June 5th.) take issue with Professor John Bourne's comments on the qualifications - or not - of the veterinary profession dealing with bTb in the past. His insultingly vague comments referred to ;

"dogmatic belief [held] by scientifically uninformed veterinary opinion".

And up with that, senior and practising veterinary personel, will not put.

Andrew Proud, BvSc, DVSM, MRCVS weighs in with a the conclusion that with a comment like that, Bourne has "destroyed any credibility that they [the ISG] might have had".

He continues:
" The 'scientifically uninformed dogmatism' is exhibited by those who take the line that the significance of cattle to cattle transmission may be assumed without evidence, while the alternative view has to be subjected to protracted, expensive and gold plated experimental method. Bourne et al, cling to the straws of cattle-to-cattle transmission, pre-movement testing and 'heightened on-farm biosecurity', but conveniently ignore the facts that led most of Dr. John Gallagher's contemporaries among officers of the State Veterinary Service of the south west to abandon their beliefs in such possibilities".

"Too many closed herds experience breakdowns, and too many herd breakdowns involve only one animal. ..[] the minimal techniques of veterinary hygiene (old and better; English for 'bio security') on which the Attested herds scheme depended, were too effective to leave any room for confidence in any control measures that stop short of separating cattle from infectious badgers. ..[] And as Paul Caruana will be well aware, in those days badger removal operations were pursued with a much greater intensity than was the norm in the 'trial'".

Another letter from Adrian Wingfield BVMS, MRCVS based in (badger free?) Cambridge also questions John Bourne's credentials.

"The ISG states that it took an explicitly scientific approach in designing the RBCT, and took full account of practical aspects and limitations from the outset. Yet we are told that many changes in procedure were adopted and implemented during the trial, including modification to the rather pivotal matter of trapping badgers.

We are told that statistical analysis has duly dealt with any aberrations arising from such operational changes, though it is, of course, a well established principle that if the data are tortured for long enough, and by a sufficient number of methods, they will eventually admit to the version of the 'truth' that is being sought.

Of equal, if not greater concern is the fact that the design of the RBCT was explicitly constrained by "a ministerial directive that badgers should not be totally eliminated from large tracts of the English countryside". It would therefore appear that, rather than be rigourously scientific, the RBCT may actually have been designed to evaluate the a form of badger cull that politicians had already decided that they might be able to 'live with' or 'sell to the public'".

That the ISG has apparently so readily bowed to political diktat may call into question the use of the words 'Independent' and 'Scientific' in the title of the group.

The vehement attack on the scientific integrity of the veterinary profession, and the very personal attacks on Paul Caruana, John Gallagher, John Daykin and colleagues, are as extraordinary as they are unconstructive, and are very clearly founded in the arrogant belief that statistical experimental science is the only discipline worthy of serious consideration.

However, colleagues may recall that the involvement and influence of statistical experimental scientists during the UK FMD outbreak in 2001, directly resulted in the greatest animal health disaster that the United Kingdom, and probably the world, has ever had the misfortune to suffer.

But I am just a vet, so what could possibly know about animal health and disease?"

Both these excellent letters are describing the group of scientists - led by the diminutive John Bourne- who for several years based their cattle-to-cattle transmission theory on the '14 million animal movements' gleaned from BCMS: announcing to all and sundry that these were made by 'cattle', when in fact they were multiplications of data.

What on earth did they expect?