Reporting Léon's Adverse Reaction - Lingering Questions

Thank you for visiting Léon’s website, and thank you for your interest in his story.

For readers who are not familiar with Léon’s story, kindly read the Introduction to the website and Léon's Canine Fibrosarcoma letter before reading this account. This will give you a better understanding of the issues discussed here and eliminate the need to repeat some of the information presented previously.

When Léon was diagnosed with a high-grade fibrosarcoma (cancer) in April 2004, it was only the first of many rude awakenings. For example, I learned that Léon’s cancerous growth was due to either the vaccines he had received and/or his microchip implant. I also learned that veterinarians, still, in the 21st century, are not required to report adverse reactions to vaccines, microchips, or to any other veterinary product.

After trying to grasp the reality that even an adverse reaction like Léon’s -- one which, beyond a shadow of a doubt, was due to a product(s) administered by a veterinarian for Léon’s “well-being” and “safety” -- is not automatically reported, I decided to report his reaction. I expected that, with a simple phone call, his case would be accurately documented by an objective, independent organization. I also expected that his data would be used to improve veterinary (and human) products, and advise the public of the potential risks of the products involved. But once again, it took a unique little French Bulldog named Léon to show me how naïve I was regarding the system that has been created by the experts in our best interests.

And so, let us retrace the arduous yet educational journey of extensively testing Léon’s tissue samples and reporting his adverse reaction.

Foiled At Every Turn

In May 2004, I sent a letter regarding Léon’s fibrosarcoma to the veterinarian who, on September 1, 2003, had vaccinated and microchipped Léon. I also sent a letter to the pharmaceutical representative who, prior to microchipping Léon, had assured me that microchip implants were extremely safe. Neither the veterinarian nor the pharmaceutical representative contacted me -- not even to enquire about Léon’s health.

In the meantime, the veterinarian (who I would publicly like to thank for her honesty and professionalism) who removed Léon’s cancerous mass had contacted a representative of the pharmaceutical company that provided Léon’s microchip. The same pharmaceutical company also provided many of Léon’s vaccinations, including the one that he received the day he was microchipped.

As this pharmaceutical representative was willing to speak with me, I called him and also sent him a letter regarding our conversations. Following are excerpts from the letter of June 2004:

“…enclosed is a copy of Léon’s passport along with documentation of all of Léon’s vaccines. Perhaps by process of elimination you will be able to determine which vaccine may have caused Léon’s fibrosarcoma. As discussed, it would be greatly appreciated if you can convince Merial of the necessity of improving their website regarding microchips. I am extremely disappointed that Merial’s website claims that there is no danger with microchips … not even the possibility of an abscess. … Merial prides itself in being a leader in the pharmaceutical industry. But after reading Merial’s French website regarding microchips, one has to stop and question the validity of all claims made by Merial. Certainly Merial does not want to lose credibility with its valuable clients. … It is also important that Merial advises all veterinarians (worldwide) not to vaccinate and microchip in the same area. While there currently may not be sufficient evidence to prove that it is risky to microchip and vaccinate the animals in the same location, common sense says this is potentially dangerous if not fatal. (As may be the case with Léon and his fibrosarcoma)… Let us work together and take a negative situation (Léon’s fibrosarcoma which appears to be vaccine and/or microchip-induced) and make something positive happen. Please do not hesitate to call me if you have any additional information regarding the cause of Léon’s fibrosarcoma…”

While waiting for more information from the pharmaceutical representative, I was hoping that the pathologist who examined Léon’s cancerous mass had found a reputable laboratory to do additional testing of the tissue samples. Unfortunately, however, one of the final notes on the pathologist’s report says:

“I thought it might be interesting to stain the tissues for aluminum, as had been previously reported in the one published study of alleged postvaccinal fibrosarcomas in dogs. I have contacted three laboratories, including the University, and no one is willing to do that laborious stain”

What a crushing blow. Not only had my canine companion developed a cancerous growth due to his vaccinations and/or microchip implant, but it also appeared that those who should have been extremely interested in his fibrosarcoma, were not interested at all, let alone helpful.

As this was a classic example of the expression “adding insult to injury,” I asked one of Léon’s veterinarians how I could report the adverse reaction. The veterinarian suggested that I contact the American Animal Hospital Association (AAHA). At the end of September 2004 I left messages at AAHA regarding Léon’s fibrosarcoma. From the beginning of October to the middle of November 2004, I spoke with three representatives of this association. This experience made me realize how dizzy and frustrated a dog must feel when it runs in circles trying to chase its own tail. It was a feeling that I would experience every time I tried to report Léon’s case.

Baffled by the lack of headway that I had made with AAHA, I looked more closely at their website. Was the answer glaring at me from the computer screen? The logo of Merial, the pharmaceutical company responsible for Léon’s microchip and many of his vaccines, accompanied by the phrase “We recognize Merial for its support of AAHA and the veterinary profession,” screamed “conflict of interest!” The phrase “conflict of interest” became hauntingly familiar to me while trying to report Léon’s adverse reaction.

After feeling as if I had run into one brick wall after another, I contacted Merial’s pharmaceutical representative again. I also sent another letter, urging the pharmaceutical company to act responsibly and to clearly inform its clients of the potential dangers of vaccines and microchips. Please click here to read this letter.

At the end of December 2004, the pharmaceutical representative said that the only laboratory that he could find that was willing to do additional testing of Léon’s tissue samples was Prairie Diagnostic Services (PDS) in Saskatoon, Saskatchewan, Canada. So, one of Léon’s wax blocks was sent to PDS for a fluorescent aluminum stain to help determine if the fibrosarcoma was a result of the vaccinations. Unfortunately, however, the laboratory results from PDS provided more questions than answers.

A Ray Of Hope

After this nauseating roller coaster ride to nowhere, I almost abandoned the idea of finding a laboratory to do additional testing of Léon’s tissue samples. And, I almost abandoned the idea of reporting Léon’s adverse reaction. But then I received a letter from the Istituto Zooprofilattico Sperimentale Delle Venezie and I knew that I could not abandon my goals.

After Léon was diagnosed with a high-grade fibrosarcoma, I read the Italian paper entitled, “Fibrosarcomas at presumed sites of injection in dogs: characteristics and comparison with non-vaccination site fibrosarcomas and feline post-vaccinal fibrosarcomas.” It seemed like a shot in the dark, but I wrote to one of the authors of this report and I received the following response:

“In our Institute we are carrying out a study on post-injection sarcomas in cats and dogs. Furthermore, last year we diagnosed a liposarcoma in site of microchip (Merial) implant in a dog. This report has already been accepted for publication, and is now in press. Therefore, I greatly appreciate to receive more detailed information about Leon’s case …”

While I was overjoyed that the Italians were interested in Léon’s case, I was also horrified to learn that Merial’s microchip had been implicated in a canine liposarcoma. Léon’s documents and his wax blocks (tissue samples) were sent to Italy.

On March 30, 2006 I kissed Léon, and we said goodbye to one another.

Three months after letting Léon go, his paper, written by the Italians and entitled “Fibrosarcoma with Typical Features of Postinjection Sarcoma at Site of Microchip Implant in a Dog: Histologic and Immunohistochemical Study,” was published in the July 2006 issue of Veterinary Pathology. Léon and I would like to take this opportunity to thank the Italian team for their interest in his case. We would also like to thank them for their professionalism and their courage to write his paper.

As for Merial, however, I often wonder why I was able to contact the Italians and request additional testing of Léon’s tissue samples but a representative (who is a veterinarian) of a large, international pharmaceutical company was not able to accomplish this task.

Knowing that Léon’s pathology report says, “If Merial wishes to pursue the matter, they can deal directly with the researchers in Italy who published that original study” (“the matter” refers to additional testing of Léon’s tissue samples), and knowing that the pathologist and Merial’s representative communicated with one another, I wonder how motivated Merial is to know, and to reveal, the truth about their products.

But then again I also wonder why, after speaking with and writing to Merial’s representative regarding the inaccurate microchip information on Merial’s French website, that instead of simply adding a section to advise their trusting clients of adverse microchip reactions, the web pages in question were removed from their website.

The Fight Continues

Although I was mentally and physically exhausted after losing Léon, I was inspired by the unrelenting courage that he demonstrated throughout his illness. I also remembered the promise that I made when I let him go -- the promise that I would share his story with the world. Armed with his newly published Italian fibrosarcoma paper (not to mention his biopsy report, his pathology report, his passport of vaccines, and other relevant data), I thought it would be appropriate to contact an organization that compiles adverse reactions to microchips.

As I had read the 2003 and 2004 Adverse Microchip Reaction Reports by the British Small Animal Veterinary Association (BSAVA), I contacted this organization at the end of July 2006. Curiously enough, the first lady that I spoke with at the BSAVA said she knew nothing of the BSAVA Microchip Committee. She said, however, that in order for veterinarians to practice in the United Kingdom, they must register with the Royal College of Veterinary Surgeons (RCVS). Thus, she suggested that I contact the RCVS. Once again, I found myself being ping-ponged from one organization to another.

I contacted the RCVS only to be told to contact the BSAVA or the Veterinary Medicines Directorate (VMD). After making several telephone calls to the BSAVA and the VMD, I sent Léon’s data to both of these organizations.

The representative of the VMD said that as Léon had been microchipped and vaccinated in France, his adverse reaction should be reported to the French authorities. So, she gave me the name of the appropriate person at the French Pharmacovigilance. Believing that I had finally found the person who would accurately record Léon’s adverse reaction, I contacted this individual. But once again I was told, “I can’t help you,” and I was given the name of a gentleman at the French Pharmacovigilance in Lyons.

The conversation with this gentleman revealed that in France there is no regulatory action on microchips. So, even if he wanted to report an adverse microchip reaction, he could not report it. He said that he would file Léon’s case under “vaccination-associated sarcomas,” and he would mention the microchip implant. As the gentleman also said that “the French database is very complicated,” and “money drives everything,” I knew that Léon’s case would probably be buried in the proverbial “bureaucratic mess.”

After trying to comprehend the fact that numerous attempts to report Léon’s case to the appropriate organizations had essentially failed, I contacted Catherine O’Driscoll of Canine Health Concern (CHC). According to O’Driscoll:

“Some years ago, the British Veterinary Medicines Directorate (which licenses veterinary drugs in the UK and monitors adverse reactions) invited CHC to attend a meeting to discuss the implementation of European legislation to trace veterinary medicines. Basically, this meant that the EU had asked governments to require that pharmaceutical companies keep track of their products in the field. We went along to that meeting and asked them to go a step further. We asked that an inexpensive piece of software be installed in veterinary surgeries. This would record medications given, and any illnesses that arose subsequently. This one simple and inexpensive piece of software would therefore enable us to see if certain illnesses arose post-vaccination. CHC was the only animal welfare organisation there. All the others were 'vested interests' such as vet groups and pharmaceutical companies. They voted against our recommendations. They actually voted against implementing the basic EU guidelines. We have been campaigning for YEARS to try to get them to change the adverse event reporting procedures. Jeanne, they even have people from the pharmaceutical companies sitting on committees deciding whether their own products caused the adverse reactions - this is government committees. We've complained, written, had press coverage... and they keep things as they are because it suits them to do this. If we spent a day talking about this, I could give you all the behind-the-scenes stories of corruption.”

O’Driscoll’s response regarding the dire status of the system for reporting adverse reactions, coupled with the tenacious effort required to report Léon’s adverse reaction, speaks volumes.

Questions And More Questions

And so we are faced with two fundamental questions: Why are veterinarians not required to report adverse reactions to vaccinations, microchip implants, or to any other veterinary product? And why are certain products highly recommended for our animals, and even required by law, yet adverse reactions to these products are not required to be reported?

Léon’s particular case forces us to ask other important questions. For example, why was it such a challenge to find a laboratory to do additional testing of his tissue samples? Why was it such a struggle to report his adverse reaction? And, if it was this difficult to document Léon’s case, how many events -- events which will remain forever unknown -- like his exist?

Other significant questions regarding the reporting of adverse reactions include: Who is ultimately responsible for adverse reactions to veterinary products? Is it the veterinarian who recommends, or administers the product? Is it the clinic or shelter that employs the veterinarian? Is it the pharmaceutical company, or any other company, that produces or endorses the product? Is it the insurance company that will not insure your animal if the product is not administered to the animal? Is it the governing agency that approves the product? Or, is it the governing organization that requires the product to be administered to the animal?

Conclusion

As the caregiver of Léon, I have borne the burden and the responsibility of his adverse reaction -- a reaction that was due to a product(s) administered by a veterinarian, endorsed and/or manufactured by a pharmaceutical company, and approved by a governing organization.

Léon’s cancerous growth clearly demonstrates that there are veterinary products that are not nearly as safe as the “experts” would like us to believe. His case also highlights many serious problems regarding the reporting of adverse reactions to veterinary products. These problems must be addressed and they must be resolved.

Léon and I would like to encourage veterinarians around the world to take the initiative and report all adverse reactions, and all suspected adverse reactions, that result from veterinary products and implant devices. We would also like to remind those involved in the production and sale of veterinary products to fulfill their promise of providing safe and effective products for our animals. And, we would like to advise the governing organizations that approve, endorse, or require the use of products for our animals to act responsibly.

Everyone involved in the production, promotion or sale of products used for animals, and humans, is reminded of their responsibility and their moral obligation to put the health of our animals and ourselves before financial gains. We urge you to clearly advise your clients regarding potential risks of your products, and to ask your clients to report adverse reactions that result from your products.

If, however, the voluntary system of reporting adverse reactions continues to fail our animals, then the public will be obliged to unite and demand the implementation and the strict enforcement of mandatory reporting of all adverse reactions (and all suspected adverse reactions) to vaccines, microchip implants and other veterinary products. The public will also be obliged to require that this data is compiled by an accurate, objective, independent organization so that the current conflicts of interest and the unacceptable inefficiency in this system can no longer survive.

In order to encourage everyone to report adverse reactions, the section entitled “Reporting Adverse Reactions” has been created for Léon’s website. This section provides websites from a variety of countries whose organizations are currently responsible for compiling adverse reaction data.

Without documentation of adverse reactions we perpetuate the myth that these events are rare. In reality, however, adverse reactions to vaccines, microchip implants and other veterinary products are not rare. Adverse reactions are often misdiagnosed, they are grossly covered up, and they are rarely reported.

Please be a part of the solution -- please take the time to accurately record and report all adverse reactions, and all suspected adverse reactions.

Thank you.

May your life be filled with love, light, courage, honour and integrity.

Jeanne, on behalf of noble Léon



August 2007