LETTER to the APVMA 21/8/2019 Re:
LETTER to the APVMA 21/8/2019 Re:
APVMA REGISTERED PRODUCT: EQUIVAC HEV HENDRA VIRUS VACCINE FOR HORSES 68996/103910, ZOETIS AUSTRALIA PTY LTD
LETTER to the APVMA 21/8/2019 Re:
Comment - The product registration holder is completing this assessment, the APVMA has literally placed the ‘fox in charge of the hen house’. It is in the product registration holders best financial interests NOT to mark #2a. Assessment statement #2d is exceptionally broad and unscientific. This is a highly subjective statement that could include explanations that have something/ nothing to do with vaccination reactions. In the case of a vaccination with limited trialling, this rating requires explanation and expansion so that more comprehensive and specific data is available. In the case of repeated reactions to a specific vaccination, the classification of ‘good alternative explanation’ should require official review.
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Question 3 – Pertaining to my preceding comment: In the case of this specific vaccination ,with very limited testing on horses before full registration and now with on-going reports of a cluster of clinical symptoms with one commonality- recent vaccination with this vaccination: how does the APVMA see question #1c as part of a reaction rating, to be a legitimate reflection of the vaccinations likelihood to cause adverse reactions when factored into the APVMA’s AERP overall scoring system and final allocation in the Causality Assessment - Veterinary Medicines ? For #1c a score of 0 is almost a ‘fait accompli’ commencing an eventual classification bias away from Probable (score 3-7)
Surely if a ‘product has limited accumulated clinical experience’ (#1c) and is experiencing reports of alleged reactions this should be a red flag and the statement should warrant a score higher than 0 so that continuing reports of this nature are investigated further? Does the APVMA acknowledge my comment as valid and will the APVMA reconsider this score rating for #1c?
(2) Causality Assessment - Veterinary Medicines
Probable - Algorithm score 3 to 7
Probable/Off-label - Algorithm score 3 to 7)
Possible - Algorithm score 0 to 2
Possible/Off-label - Algorithm score 0 to 2
Unlikely - Algorithm score –1 to –6)
Question 4 – Where classifying ‘a good alternative explanation’ is in the hands of the product registration holder: In what way is this process re #2 Assessment statements, impartial, scientific, quantitative?
What measures does the APVMA take to review the product registration holders’ classification of ‘good alternative explanation’?
Does the APVMA know what the product registration holder’s ‘good alternative explanations’ are?
Question 5 - Why doesn’t the APVMA ask what the specific ‘good alternative’ explanation is? This would give a far clearer picture of the appropriate applications for this vaccination. Is the APVMA aware that this vaccination is gaining the reputation as the ‘coincidence vaccination’?
How often does the APVMA review a registered product when the initial evaluation is undertaken by the product registration holder; what are the APVMA’s ‘red flags’?
Question 6 – The negative score allocated (-1) to #2c above weights the Causality Assessment - Veterinary Medicines category, away from probable. Why has the APVMA allocated a -1 score to such a subjective, vague statement with no qualifying information?
(2) Causality Assessment - Veterinary Medicines Algorithm scores for ‘Possible - Algorithm score 0 to 2 and Possible/Off-label - Algorithm score 0 to 2’, scores are the same. Who /how is the determination made as to which category the ‘reaction’ falls into?
Comment re #4 Timing of Event – Again, in the case of a vaccine with limited testing the answer is in all probability going to be #4b if answered honestly, and again the allocated score is 0. Yet again biasing the eventual score away from ‘Probable’.
I now refer to the following:
Maitland Greencross large animal veterinarian Rod Starr said “it was important to keep in mind that illness 24 hours after the vaccination was potentially not a side-effect.”
“A side-effect is what happens 12 to 24 hours after the vaccine is given,” Dr Starr said.
Question 7 - Re Timing- What exactly does the APVMA classify as ‘a likely reaction time’? Is it 12 – 24 hours or is it left up to the product registration holder? If so why and when does the APVMA review this time frame?
Re Timing- If ‘12 to 24 hours after the vaccine is given’, is the accepted time frame for reactions to a vaccination, then any cluster of clinical symptoms outside this time with the common precursor being this vaccination, will be assessed as #4c with score of -2 with the assessment bias again being away from the ‘probable’ category. Is this as correct statement?
Re Timing- If the product registration holder themselves defines ‘a likely reaction time’– how does the APVMA see this #4 as impartial or scientific in a self-assessment situation?
Question 8 – Re Timing- If the APVMA does not process the original raw data regarding alleged reactions (the product registration holder does), then how can the APVMA be aware of the number and range of alleged reactions outside the expected time frame that have the one common factor, this vaccination. There is a high probability that Zoetis has classified these as #4c with a score of -2, more bias away from probable?
Is the APVMA intending to investigate the alleged reaction to this vaccination outside the time frame, further; or will this be left up to Zoetis? How can this revision occur if the original reaction data rests with Zoetis and the APVMA only sees the product registration holder’s final allocation in the Causality Assessment - Veterinary Medicines?
Comment: regarding #6 – Again with reference to this specific vaccine, statement #6b is almost a ‘fait accompli’ regarding vaccinated horses and their owners. What owner in their right mind would re vaccinate their horse when they suspect that serious reactions were caused by the first vaccination? IMO the construct of your (2) Algorithm virtually guarantees a ‘0 score ‘
The construct of the APVMA’s (2) Adverse Experience Reporting Program (AERP), The Causality Assessment Algorithm - For Veterinary Medicines: exhibits serious flaws in the construct of the ‘algorithm’. This deficit is further exacerbated where a product has limited testing prior to full release. In my opinion the (2) statement scores are heavily weighted towards 0. This represents an unscientific bias that is qualitative rather than quantitative. The procedure whereby product registration holder must subsequently report their findings using (2) to the APVMA poses serious questions regarding vested interests and impartiality.
Question 9 – Regarding - Number of equine reports classified by the APVMA to 31 March 2017 (grouped by the year of reaction) on https://apvma.gov.au/node/15786 -Why are these figures so far behind? When will they be updated?
Is the data in this table an exact representation of the assessment provided by Zoetis / been a subject of the APVMA’s statistical ‘random sampling techniques’ or been edited by the APVMA?
Question 10 - Does the APVMA acknowledge and /or have any intention of addressing the serious issues I have outlined in my last comment #6 above re the construct of the APVMA’s (2)Adverse Experience Reporting Program (AERP), The Causality Assessment Algorithm - For Veterinary Medicines
Regarding unsubstantiated claims and advertising, I refer specifically to-
(7)ADVERTISING AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS- INFORMATION INCLUDED ON REGISTERED PRODUCT LABELS
Section 84 of the Agvet Code specifically deals with claims made on product labels. Persons must not make any claim, or permit any claim to be made in respect of a registered chemical product that is not consistent with the approved label for that product.
Correspondence allegedly from the APVMA regarding unsubstantiated claims: Links
Comment- misrepresentation could have very serious consequences
I herein notify the APVMA that public representations are being made regarding unsubstantiated allegation that this vaccination protects humans from Hendra infection being transmitted from vaccinated horses. This is contrary to the product labelling.
"The veterinary clinics have a legal responsibility with a zero-tolerance level for exposure of our staff, horse staff or the public to any horse with an identified risk of HeV infection," read a statement from the three clinics.
Alleged Chris Wallers letter :
Comment- this misrepresentation could have very serious consequences -
Immunising a horse against Hendra with this vaccine is a false representation of an Occupational Health and Safety measure to protect humans from Hendra infection transmitted from horses and should not be promoted as such. I refer to (4) and (5) quoted here-in regarding virus shedding
Belief in this false representation ( as an OHS measure) by Immunising horses with this vaccine will in all probability provide handlers with a false sense of security. The vaccine masks the clinical symptoms of a horse with the Hendra infection and increases the likelihood of handlers not taking appropriate precautions and/or becoming less vigilant. This has the potential to increase human infections. Not correcting this misrepresentation is a failure in duty of care by the responsible organisations
Question 11 a- Is the APVMA the official body that would undertake legal recourse in the matter of unsubstantiated allegations and false advertising? If not, who is responsible?
Question 11 b- If YES to 11a- Is the APVMA pursuing any prosecutions/actions against individuals /associations making unsubstantiated claims/advertising transmission from horse to humans? If not, why not?
Question 11c- What is the process required to initiate such action? Doesn’t the APVMA have a duty of care to end users of APVMA registered products?
Question 11d- With reference to (8) and (9) above. Can you verify that the APVMA is the source of this communication? If yes, please verify that the content of these communications is correct.
Question 11e- IF yes to 11d-As the APVMA allegedly knows about the miss-representations regarding this vaccination, why have penalties/ actions not been pursued by the APVMA / the APVMA passed this information onto the appropriate authority?
References - Links:
(2)Adverse Experience Reporting Program (AERP) , The Causality Assessment Algorithm - Causality Assessment Algorithm - For Veterinary Medicines .
(4) product information sheet http://websvr.infopest.com.au/labelrouter/label?productcode=68996&labeltype=L&Mode=1
(5) https://apvma.gov.au/node/12881 Effectiveness of the vaccine
(7)ADVERTISING AGRICULTURAL AND VETERINARY CHEMICAL PRODUCTS- INFORMATION INCLUDED ON REGISTERED PRODUCT LABELS https://www.legislation.gov.au/Details/C2012C00810