Fort Dodge : The Saga Continues 2004

Much has been said about vaccinations.

Much is still been said about vaccinations.

Much will continue to be said about vaccinations.

I began this section on my website after making contact with Dot Sweeney regarding the difficulties she experienced with a litter of her Black Russian Terriers after receiving their vaccinations, Duramune C4 which is a new modified vaccine manufactured by FORT DODGE AUSTRALIA.

But is it?

Further correspondence with Dot Sweeney has revealed that it is pretty darn difficult to get a response from Fort Dodge regarding the hand delivered warning letter by the FDA.

On 31 March 2004 U.S. Food and Drug Administration Health and Human Services hand delivered a warning letter to Mr. E. Thomas Corcoran, President Fort Dodge Animal Health, a Division of Wyeth, Inc., regarding a number of problem areas concerning the manufacture of animal pharmaceuticals.

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5. Investigations of a batch failure or any of its components processed in the aseptic processing area did not extend to other drug products that may have been associated with a specific failure or discrepancy. The heat exchanger used in the Small Volume Parenteral manufacturing rooms [redacted] and [redacted] was found to be contaminating the water for injection (WFI) with bacteria. The failure investigation did not extend to reviewing the possible impact on other previously manufactured drug products. In addition, the heat exchanger continued to be used to manufacture other parenteral products after the equipment was identified as being contaminated. Furthermore, the filter integrity test procedure outlined in SOP 14-177-01 does not specify a limit on the number of times a filter can be flushed or rewetted. [21 CFR 211.192 and 21 CFR 211.42(c)(10)(vi)]

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Further the letter states:

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It is our assessment that the deviations listed above and discussed with your firm’s senior management are significant and are a reflection of weaknesses in one or more of the systems designed to control the manufacture of veterinary pharmaceuticals purported to be sterile.

The cGMP deviations noted during the December 2003 establishment inspection, where the firm’s employees failed to follow Standard Operating Procedures, do not appear to be isolated events. On November 12, 1999, your firm recalled a lot of Synovex Plus (Trenbolone Acetate and Estradiol Acetate) because it was released for distribution despite failing content uniformity testing. On or about April 30, 2002, Fort Dodge Animal Health sent a letter to FDA’s Center for Veterinary Medicine's (CVM), Division of Compliance requesting the rework of one lot of Synovex H (Testosterone Propionate, Estradiol Benzoate) because the release assay showed that the product potency was approximately 10% below the labeled claims.

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The complete letter can be read by clicking this piece of text.

Concerns, immediately, crept into our own minds as to what was going on with Fort Dodge. Zebedee, a male puppy from one of our litters fell victim to an adverse vaccine reaction.

We made a call to Richard Howie on 13 May 2004, Victorian representative for Fort Dodge, thus far no response has been received.

We then called Raphael Zwijnenberg [technical questions RE: animal products] to clarify the issue regarding this warning letter. Mr Zwijnenberg returned our call. He stated that the plant in question is one where animal antibiotic are manufactured. No vaccines are manufactured at the named plant. He was very clear on that. However it does raise questions, regardless of which plant is involved, as to the professionalism and duty of care the company shows in their approach to manufacturing products.

We all have to make our own decisions about the health and well being of our beloved canine friends.

We rely on information from people we trust.

Perhaps what we need to do, once we get that information, is question it, dig around for more information and do plenty of talking to others who are willing to share their knowledge and experiences.

Dr Jean Dodds of Santa Monica, CA USA, has done wonderful and extensive research on vaccinations and the effects of them on various breeds of dogs. She has also began work on alternatives such as the effects of homeopathic nosodes instead of vaccinations, which is funded by the American Holistic Veterinary Medical Association. This research could lead to a much healthier approach to vaccinating or not vaccinating our four legged canine pals.

The topic of vaccinations is not just an Australian phenomenon. It is one discussed in many develpoed countries. Ms Catherine O'Driscoll has been very active and instrumental in bringing the effects of vaccinations to the attention of dog owners, breeders and the veterinary profession in the UK, and indeed world wide. She is the founder of Canine Health Concerns [C.H.C.] and the author of the famous book "What Vets Don't Tell You About Vaccines".

Some ten years after the formation of C.H.C. campaign to end annual vaccination, a letter appeared in Veterinary Times, UK - at the end of January 2004. To read this letter in full, click here. Our gratitude is extended to Cathrine for not just her tireless and passionate work regarding vaccinations but for permission to use this information and further help others understand.