VMD Reassurances over Lepto4 vaccine


Dear Sir

Open Letter: Who is the ‘Regulator’ protecting? Is it the animals and their owners – or the veterinary vaccine industry?

I refer to your on-line report ‘VMD offers reassurance over vaccine concerns’, dated March 20, 2017, (https://www.vettimes.co.uk/news/vmd-offers-reassurance-over-vaccine-concerns/) with the sub-heading, “The VMD has moved to reassure vets following concerns raised in media reports of serious adverse events in dogs given the vaccine containing four strains of Leptospira bacteria”. The VMD stated in your report: “We would like to reassure vets – and through them, dog owners – we are constantly reviewing adverse event report data to ensure the benefits of each UK licensed veterinary medicine product outweighs the risk posed by their potential side effects.”

Bah humbug. Let me be clear: every reaction to a vaccine that is not needed is unacceptable. So let us examine the risk:benefit ratio in relation to the leptospirosis vaccine in the UK from a pet owner’s point of view, rather than the view of a ‘regulator’ which backs corporations every time rather than the animals it is supposed to protect.

The VMD 2014 Review of Adverse Events Report stated: “For the purposes of this report, we have classified core vaccines as those giving protection against any combination of distemper, parvovirus, adenovirus, parainfluenza and/or leptospirosis. We have done this, as in the UK dogs are almost invariably vaccinated against leptospirosis at the same time as the other diseases, which makes it very difficult to determine which vaccine component is responsible for the signs observed.”

So, in 2014, the VMD lumped Lepto4 adverse reactions in with core vaccines. Is this good science? It cannot be, for it demonstrates an apparent inability to ascertain the adverse effects of a new vaccine which has stimulated media reports prompted by grieving owners, and caused thousands of dog owners to join the ‘Lepto4 – our experiences’ Facebook group. And now, in response to further questioning, we have the figures obscured in percentages alongside reassurances based on what? Would this be to hide the known safety concerns surrounding the Lepto4 vaccine?

Why does the VMD not give us the actual numbers? Why reduce the deaths and abject suffering of Lepto4 victims, and their owners, to percentages? The VMD admitted to the Telegraph in July 2016 that there had already been 120 deaths and 2,000 adverse reactions in the UK. What is the figure now? (http://www.telegraph.co.uk/news/2016/07/02/dogs-dying-after-having-protective-vaccine-owners-claim/)

How SAFE is this vaccine? Or is the VMD intimating that the Lepto4 vaccine from MSD is no more damaging than the other vaccines our dogs are subjected to, despite a huge rise from two (L2) to seven (L4) reactions per 10,000 doses sold? And what about the reactions which aren’t reported?

The European Medicines Agency Veterinary Pharmacovigilance Report 2014, didn’t have the same problem as the VMD. Specifically concerning Nobivac Lepto 4, the EU was able to establish that: “Several signals were identified, mainly relating to anaphylaxis and various immune-mediated conditions such as anaemia, thrombocytopenia and arthritis.” And death, of course. Let’s not forget death.

So whilst the European MCA was able to separate the Lepto vaccine from other vaccines but the UK’s VMD was not, the EU nevertheless gave this vaccine a special mention in its report and sent the manufacturer off to investigate. And because it is a vaccine (rather than, say, a herb which can’t make the veterinary pharmaceutical industry huge profits) L4 is still on the market and being injected into dogs – despite the fact that a percentage of dogs will die or have their bodies ruined as a result.

This means that every dog who receives the Lepto 4 vaccine is part of a medical experiment involving a vaccine under scrutiny, with a known association with death and severe debilitating disease. Are pet owners made aware of this before they are persuaded to part with their money and have them injected with this product?

Does the VMD even know how severe a risk leptospirosis is in the UK? Does anyone?

The CICADA survey from MSD (http://uk.cicadasurvey.com/) furnishes veterinarians with figures, but dog owners must satisfy themselves with colours on a map, which stinks of obfuscation. But where did the data come from?

In May 2014, Christopher Ball from the University of Liverpool presented a thesis about leptospirosis in dogs. He thanked “MSD Animal Health for funding the project, without which none of this work would be possible”.

Mr Ball’s MSD-funded thesis, which may be found through a web search or, should that fail, through Canine Health Concern, appears to provide MSD with its data on leptospirosis incidence in the UK for its CICADA website. However, the thesis (which resulted in Mr Ball being awarded his PhD) also states:

  • Due to the perceived low rates of infection in the UK, the canine leptospirosis vaccine is also not currently considered a ‘core’ vaccine in the UK (unlike the vaccines for parvovirus, para-influenza virus, canine distemper and infectious hepatitis).
  • In the UK, the human vaccine is not routinely administered due to the low incidence of cases (between 50-60 a year) (HPA, 2012).
  • Climate plays a role in Leptospira infection rates, with temperate climates not having extreme weather situations that may contribute to infection rates. According to the Köppen climate classification, the UK has a rating of Cfb, meaning cooler summers but also milder winters. The classification reflects the milder climate changes between seasons which reduce the likelihood of leptospirosis.

Mr Ball sent out a questionnaire to veterinary practices in the UK for his thesis. Of the 472 questionnaires he sent out, only 89 were returned. Of these, by far the largest response came from vet practices which had seen no lepto cases in the previous twelve months. Only 13 practices reported a case within the last twelve months, of which only five had lepto confirmed by a laboratory test. A further 29 practices reported having seen a case within the last 15 years. No practice in the study reported seeing two or more suspected (or confirmed) cases in the 12 previous months. Does this make leptospirosis in dogs ‘endemic’ or a problem large enough to risk this vaccine? I think not.

Very similar extrapolated figures were presented by MSD on its website for the ‘CICADA’ survey, which is being used to justify annual vaccination against leptospirosis. Yet, to anyone unwilling to subject their dogs to unnecessary vaccines, these figures highlight a product desperately looking for a market, and not a validation for Lepto4.

What makes MSD’s Lepto4 vaccine different to its Lepto2 vaccine, apart from the number of serovars present? Do its ingredients give us a clue?

Thiomersal (mercury). Studies show that this mercury-based compound used as a vaccine preservative induces brain damage similar to that seen in autism patients. As an example, DProgram.net July 10, 2009, Toxicological & Environmental Chemistry June 4, 2009; 91(4): 735-749: “Thimerosal was found to be significantly more toxic than the other metal compounds examined.”

Sodium chloride (salt): MSD thinks it’s a good idea to inject salt into our dogs: salt that we avoid in their foods.

Potassium chloride – used to cause cardiac arrest within the “three drug cocktail” used for executions by lethal injection. Side effects (from uses not intended to kill) can include gastrointestinal discomfort, including nausea and vomiting, diarrhoea, and bleeding of the digestive tract. Too much potassium in the blood can lead to hyperkalaemia.

Disodium phosphate dehydrate (DPD) – used within saline laxatives and enemas. According to Toxnet, part of the American government’s National Institute of Health, “Saline laxatives are tolerated reasonably well by most patients. However, they need to be used with caution or avoided in patients with renal insufficiency, cardiac disease, or pre-existing electrolyte abnormalities and in patients on diuretic therapy. Is use by injection safer than use by laxative?

Potassium dihydrogen phosphate (PDP): According to medsafe.govt.nz’s PDP factsheet, PDP injections should be administered with caution in people who already have high phosphate levels, such as those with hypoparathyroidism, chronic renal diseases, rhabdomyolysis, and heart disease. PDP injection is contraindicated for those with severe renal function impairment, Addison’s, and low calcium levels, and there’s a wide range of drugs which contraindicate its use, including NSAIDs, ACE inhibitors, calcium containing medicines, diuretics, and digitalis containing medicines. Adverse effects associated with PDP injection, include very low or irregular blood pressure, heart attack, high blood potassium, tiredness, weakness, slow heart rate, anxiety, trouble breathing, convulsions, muscle cramps, and acute renal failure.

I wonder if veterinarians take all of these contraindications and adverse effects into account when they go along with the ‘need’ to vaccinate dogs against lepto – a RARE disease in the UK?

Interestingly, the Nobivac Lepto 2 datasheet only lists Thiomersal under its ‘pharmaceutical particulars’.

We are also guessing about adverse reactions because even the VMD admits that there is a serious problem with the under-reporting of adverse reactions. So what we see could just be the tip of the needle.

There’s also the question: “does this vaccine prevent disease?”

Well – the jury is sort of out. MSD claims they’ve got the four main serovars covered, but our thesis author says it has not been possible to identify which are actually causing disease in the UK. Veterinary Times quotes the VMD:

“In other words, the VMD has received fewer than two adverse reactions for L2, and fewer than seven for L4, for every 10,000 doses sold. This includes every suspected adverse event reported – even cases that were considered unclassifiable or were later found to be unrelated to the vaccine.

“The overall incidence of suspected adverse reactions for both L2 and L4 vaccine products is therefore considered to be rare.”

I have to wonder whether veterinarians are advocating the leptospirosis vaccine so they can keep on pulling in revenue now that the WSAVA has informed pet owners that annual shots for parvovirus, distemper and adenovirus are not needed? Veterinarians, please think: do you wish to lose the trust of your clients altogether? And when will the people who have sworn to do no harm apply rigorous attention to the problem of VMD-industry collusion?

Yours faithfully
Catherine O’Driscoll
Canine Health Concern