Message Board
Bio Spot Side Effects
March 2011

CLASS ACTION LAWSUIT


On 3/2/10, a lawsuit  seeking class action status was filed on behalf of pet owners against Hartz, Sergeant's, and Summit VetPharm (maker of Vectra and Vectra 3D, which are sold by Banfield Pet Hospital's under the name FirstShield and FirstShield Trio).

On 8/25/10, a lawsuit seeking class action status was filed on behalf of pet owners against Central Garden and Pet - the parent company of Farnam (maker of Adams and Bio Spot flea and tick products) and Wellmark International (maker of Zodiac flea and tick products).

The lawsuits seek injunctive relief in the form of a recall of the offending products, a refund of the purchase price, for compensatory damages, punitive damages and other relief.

For additional information concerning this lawsuit, click here.

If your pet was harmed by a flea and tick product made by one of the above mentioned companies, and you would like to participate in this class action,
please contact:

Jacqueline Mottek
Positive Legal Group
jmottek@gmail.com
415.302.5371 (cell)


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/1/11)


Please send me document number D219825 -- it's a memorandum dated April 23,
1996, from OREB to RCAB regarding a post-application exposure assessment of
Frontline (fipronil) spray and/or spot treatment for pets.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is email that I sent to Kelly Sherman at the EPA on 3/2/11)


Dear Ms. Sherman,

I am writing in regards to a fipronil (Frontline) pet treatment post-application exposure study that you reviewed for ethics on August 10, 2009:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/129121/129121-2009-08-10a.pdf

I would like to bring to your attention a conflict of interest that ought to preclude reliance on
that study in EPA actions taken under FIFRA.  As you stated in your review, the study was funded by Merial, the Frontline registrant.  You also stated that the study did not report any independent ethics oversight or review of the protocol or of the conduct of the research.

In case you were not aware, the above study was submitted by Merial in response to an
EPA risk assessment, which had determined that exposure estimates were unacceptable:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/129121/129121-1997-05-15a.pdf

In other words, the registration of the fipronil pet treatment was dependent upon the submission of an acceptable exposure study.  The fact that the study was not only funded
by, but conducted in part by Merial, was a serious conflict of interest.

I would also like to bring to your attention another disturbing fact.  One of the study's authors (Andre Weil) also happened to be one of the inventors of the fipronil pet treatment:

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=
1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=6&f=G&l=50&co1=
AND&d=PTXT&s1=fipronil&s2=weil&OS=fipronil+AND+weil&RS=fipronil+AND+weil

Clearly, Merial and Mr. Weil had a significant financial interest in the outcome of the study,
but that was never mentioned in the EPA's technical review of the study:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/129121/129121-0000-00-00b.pdf

In fact, it states, "The study author stated that there were no influences, impacts or circumstances which might have impaired the integrity of the study."

In light of these revelations, and the fact that the EPA still relies upon that study in actions
taken under FIFRA, I hope that you will seriously consider reevaluating the study for ethical conduct.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/3/11)


Please send me EPA's review of study titled, "Assessment of Residential Exposure to Permethrin During and Following Spot-on Application of K9 Advantix to Dogs" (MRID
465941-01).

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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Re: Banifield First Shield Trio

I gave my dogs two austrailian shepherds this product yesterday 3-4-11 and on 3-5-11 at 330am my dogs are having an awful reaction.  My boy Ozzie has chewed himself raw and
is very lethargic, he will not even come to me and usually I can't keep him off of me.  This is very upsetting.  There's no one on gods green earth that can tell me and this product has
not caused this, and this is only 10 hrs later.  Do not use this product.

David  3/5/11


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Household Insecticides May Lower IQs

http://www.columbiaspectator.com/2011/02/28/mailman-researchers-insecticides-may-
lower-iqs

Excerpts:

Household insecticides don’t just smell bad—they may cause adverse developmental
effects in young children, according to a new study by researchers with the Mailman
School of Public Health.

IQ scores of children at age three were approximately four points lower than average
among children who had high exposure during pregnancy to piperonyl butoxide (PBO),
an additive used in pyrethroids, a common class of insecticides.

“It is a very significant drop when you think about it in terms of shifting the distribution of
IQ scores in a community,” Dr. Megan Horton, the lead researcher on the study, said.

Horton compared the effect to low-level lead exposure, and noted that it could be sufficient
to shift the lower end of IQ scores into “an IQ category that may need special services.”

According to Dr. Robin Whyatt, one of the study’s authors and a deputy director of
the Columbia Center for Children’s Environmental Health, studying these effects is
important because pyrethroid insecticides are increasingly used as replacements for organophosphates, a class of insecticides that was regulated by the Environmental
Protection Agency in 2001 following similar evidence of risks from prenatal exposure.

Although the results of the study are preliminary, the researchers recommend that pregnant women and those with young children avoid the use of spray pesticides.

“It’s prudent to avoid these exposures to the extent possible, if there’s any possibility that
they may be causing harm,” Whyatt said.


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/6/11)


Please send me "SOP13: Postapplication Exposure Assessment for Children from Pet Treatments" (1/2002), which was published by the HED Exposure Science Advisory Committee.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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Toxic Flea Collars Pose Unacceptable Health Risks to Children

http://switchboard.nrdc.org/blogs/mrotkinellman/nrdc_lawsuit_secures_warning_l.html

Excerpts:

Over a year and half ago, I designed a study to test the residue levels on pet fur from these
flea collars. We tested numerous cats and dogs, and released a report documenting high levels of chemicals, like propoxur, on the fur of pets wearing flea collars. Those residues
were easily transferred onto hands or surfaces, resulting in the potential for toxic exposure
to pet owners that exceeded acceptable limits, particularly for young children.

My colleague, NRDC Senior Scientist & physician Dr. Gina Solomon, also chronicled her
own experience with these nasty collars. Based on our findings, last year we sued the manufacturers and major retailers that sell flea collars with propoxur for failing to comply
with California’s law requiring warning labels on products with cancer-causing chemicals. 
We also petitioned the Environmental Protection Agency (EPA) to ban the use of these products altogether, based on the neurotoxic risks to children.

After we submitted our report and petition to EPA, the agency did a risk assessment that confirmed unacceptable levels of risk to young children from use of flea collars with propoxur. EPA found serious health risks despite major flaws in their assessment, for example:

* EPA continued to use the ridiculous assumption that child only puts their hand in their
  mouth once a day while playing with a pet.
  
*  EPA ignored the potential for exposure to pesticide residue through the skin.
  
* EPA’s risk assessment failed to consider cancer risks.

Even while underestimating the threat for all of these reasons, they were able to confirm
the serious health risks.

All this together, is ample evidence to take get these products off the shelves.

Some Flea collars with propoxur include:

  * Adam’s brand “Plus” collars
  * Bio Spot brand collars
  * Sentry brand “Dual Action” collars
  * Sergeant’s brand collars
  * Vet Kem brand “Tick Away” collars
  * Zodiac


Here is Sergeant's/Wellmark International's response to EPA's propoxur risk assessment:

http://www.biospotvictims.org/EPA-HQ-OPP-2009-0806-0017.1.pdf


Here is the supplement to the NRDC's petition to cancel propoxur pet collars:

http://docs.nrdc.org/health/files/hea_11011801a.pdf

Excerpt:

"All the evidence before the Agency provides EPA with ample reason to cancel pet uses for propoxur.  EPA should immediately take action on their own assessment
and the evidence presented here to protect children from these dangerous products and cancel pet uses of propoxur."


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Frontline and its Generic Equivalent - Is It Really Safe?

On January 14, 2011, Sergeant's Pet Care Products, Inc. announced it had entered into
a license agreement with Sumitomo Chemical Co., Ltd., to manufacture and sell the generic equivalent of Frontline and Frontline Plus.  These products contain the pesticide fipronil.

Here is Sergeant's press release regarding it:

http://www.businesswire.com/news/home/20110114006092/en/Sergeants%C2%AE-Pet-Care-Products-Acquires-Rights-Patent

Excerpt:

“The generic concept is one that is known and trusted by consumers for human medication and treatments. More and more, generic formulations are gaining popularity in the pet market as well,” states Caryn Stichler, vice president of marketing for Sergeant’s. “We are thrilled
to be able to deliver a trusted, veterinary-recommended product to pet owners that will be available where they shop regularly and at a lower cost than the brand-name products
currently available.”

Sergeant's new fipronil-based products will soon be available under the names Pronyl OTC and Pronyl OTC Plus, and they will also be available under its Sentry brand as FiproGuard
and FiproGuard Plus.

http://www.petproductnews.com/headlines/2011/03/16/sergeants-introduces-generic-topical-flea-tick-products.aspx

For years, veterinarians have urged their clients to avoid dangerous over-the-counter flea control products, and have widely recommended using Frontline products.  In fact, Frontline
is the world's best selling flea and tick treatment.  

Despite its popularity, is Frontline really safe for pets? 

Frontline is not FDA-approved. It's registered with the EPA as a pesticide, and
it's sold exclusively through veterinarians due to a marketing strategy.  

Merial (the manufacturer of Frontline) often says, "The number of adverse events reported
for Frontline has remained consistently low since the product's introduction in 1996."

Merial has also intentionally misled the veterinary community and pet owners by stating
that Frontline -- unlike other flea and tick treatments -- is not absorbed into the body and doesn't circulate through the bloodstream, therefore it's very safe for pets and people.

http://www.petplace.com/drug-library/fipronil-frontline/page1.aspx

http://www.frontlinevipclub.com/index.php?mode=main&task=shw_submenu&id=2

However, this EPA memorandum from 1996 clearly states otherwise:

http://www.epa.gov/pesticides/chemical/foia/cleared-reviews/reviews/129121/129121-85b.pdf

The EPA recently investigated pet spot-on products and found that ALL of the products, including Frontline, were linked to health issues ranging from mild skin irritation to seizures and, in rare cases, to the death of the pet.

http://www.scientificamerican.com/article.cfm?id=small-dogs-susceptible-flea-poison

Here are the EPA's evaluation reports for Frontline/Frontline Plus for Dogs:

http://www.biospotvictims.org/EPA-HQ-OPP-2010-0229-0015_2_.pdf

http://www.biospotvictims.org/EPA-HQ-OPP-2010-0229-0017_2_.pdf

Health Canada, which collaborated with the EPA on the pet spot-on product investigation, noted that a key limitation was the under-reporting of incidents by the manufacturers.

http://www.hc-sc.gc.ca/cps-spc/pubs/pest/_decisions/epir-edirp2010-flea-tick-antipuces-antitiques/index-eng.php

Several people have mentioned to me that when they called Merial to report an adverse incident, they were told that Frontline does not cause serious adverse reactions!

Here's what the American Veterinary Medical Association has to say about the risks of
spot-on flea and tick treatments (including Frontline):

http://www.avma.org/animal_health/flea-tick-products-EPA_faq.asp

Besides the risk to pets, is it safe for people to be around Frontline-treated animals?

According to the EPA's website:

"EPA is dedicated to the protection of children risks associated from exposures to pesticides, particularly those used residentially. EPA assesses all pet pesticide treatments, including spot-on products, using a screening level approach. Our review of these products includes a dermal assessment for adults and dermal and oral exposure assessment for children based upon conservative assumptions of pet contact and pesticide transfer to the persons exposed. Inhalation assessment to pet pesticide treatments is considered on a case-by-case basis. EPA scientists estimate the amount of applied pesticide that can transfer from the animal to the child’s skin from hugging or otherwise contacting a treated animal. Based on these estimates, the EPA ensures that children are protected from exposure to pesticide treated pets."

That sounds reassuring, but Frontline was registered (approved) before the EPA
was required to implement a new safety standard for infants and children. 

Prior to registration, the EPA had serious concerns about the risks that Frontline posed to commercial pet groomers, and therefore made the registration dependent on the submission of an acceptable dermal exposure study.

http://www.biospotvictims.org/Ppls_38_3.gif

Later, when the EPA assessed the risk that Frontline posed to children, instead of basing
its assessment on conservative assumptions, the EPA relied on Merial's unpublished -- and deeply flawed -- dermal exposure studies, which greatly underestimated the amount of pesticide that is transferred during pet contact. 

http://www.biospotvictims.org/129121-114.pdf

If the EPA's risk assessment had been based on conservative assumptions, it
would have determined that Frontline poses unacceptable risks to children.

(Here's an article regarding the EPA's reliance on unpublished industry-backed studies:)

http://www.scientificamerican.com/article.cfm?id=epa-atrazine-herbicide

Here's what the NRDC's GreenPaws website has to say about Frontline:

"There are significant health concerns associated with fipronil but in areas
with severe tick problems, limited and careful use may be warranted.  Use
sparingly and avoid if pregnant or around young children."

Here's a study regarding human exposure to fipronil from Frontline-treated dogs:

http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=
12361121&dopt=AbstractPlus

Excerpt:

"Repeated exposure to such contamination can pose human health risks."

Here is a recent study that examined acute illnesses associated with exposure to fipronil:

http://www.biospotvictims.org/2010_fipronil_clinicaltox.pdf

Excerpt:

"This study also found that pet-care products (Frontline) were related to more than one-third of cases and accounted for the majority of childhood cases (64%)."

Here is a presentation to California's Scientific Guidance Panel regarding fipronil:

http://oehha.ca.gov/multimedia/biomon/pdf/0709IprodioneOcthilinoneFipronil.pdf

Excerpt

"Potential for continuous exposure in home.  Children may be at greater
risk.  Potential concerns for cancer, hormone disruption, and developmental neurotoxicity."

Here's a recent study that examined the potential for fipronil to produce developmental neurotoxicity:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2650714/

Excerpts:

"Our results suggest that fipronil is inherently a more potent disruptor of
neuronal cell development than is chlorpyrifos."

"The actual human exposure to FPN [fipronil] is poorly explored, but, as
just one example, topical pet treatment preparations contains as much as
five orders of magnitude higher FPN concentrations than those used in our
assays; with routine “petting” transfers to human skin reach 600 ppm."

Here's another recent study that examined the potential for fipronil to produce developmental neurotoxicity:

http://www.ncbi.nlm.nih.gov/pubmed/21167920

Excerpt:

"The above data seem to justify very recent concerns that FIP has the
capacity to induce developmental neurotoxicity in mammals."

Here's an excellent website regarding the toxicity of fipronil:

http://www.sailhome.org/Concerns/BodyBurden/Sources3/Fipronil.html

Excerpt:

"Research now shows that even minuscule exposure is toxic to vertebrates
including humans and pets."

Here's Beyond Pesticide's fact sheet for fipronil:

http://www.beyondpesticides.org/pesticides/factsheets/Fipronil.pdf

Here are the NPIC's fact sheets for fipronil:

http://npic.orst.edu/factsheets/fipronil.pdf

http://npic.orst.edu/factsheets/fiptech.pdf

As mentioned in the above fact sheets, fipronil is highly toxic to honey bees and
aquatic organisms.  In fact, it's so toxic to the environment, several countries --
including China -- have banned it!

Frontline and FiproGuard also contain 75-90% diethylene glycol monoethyl
ether -- an industrial solvent that increases the absorption of fipronil through
the skin, and poses adverse health effects for humans and pets:

https://fscimage.fishersci.com/msds/07332.htm

UPDATE:  On 4/20/11, FidoPharm (Velcera) announced the introduction of a line of
generic Frontline products for cats and dogs, called PetArmor and PetArmor Plus

UPDATE:  On 6/9/11, Novartis launched a new line of generic Frontline products for
cats and dogs, called EasySpot and Parastar.   These products will be manufactured
for Novartis by Sergeant's!

UPDATE:  Sergeant's FiproGuard will also be distributed under the Martin's brand
(Control Solutions, Inc.) as Prefurred for Cats and Prefurred for Dogs.

UPDATE:  Incredibly, NONE of the new generic Frontline products have
been required to be tested for toxicity, safety, or efficacy.  Instead, the EPA
has allowed the manufacturers of these products to cite data that were
previously submitted for Frontline!


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/15/11)


Please send me the Registration Jacket for EPA Reg. No. 2517-140 (Sergeant's fipronil + cyphenothrin for dogs).

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/15/11)


Please send me the Registration Jacket for EPA Reg. No. 2517-136 (Sergeant's fipronil squeeze-on for dogs).

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/15/11)


Please send me the Registration Jacket for EPA Reg. No. 2517-134 (Sergeant's fipronil + methoprene for dogs).

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/21/11)


Please send me EPA's review of study entitled, Dermal Exposure of Commercial Pet Groomers During Application of Frontline Top Spot Treatment (1997) (MRID 444333-03),
and please send me all records related to EPA's ethics review of that study in 2009.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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It took me a while to put 2 and 2 together but it finally kicked in as to what happened. I have had dogs for 30 years. I never used any flea or tick treatments until about 3 years ago. The fleas were taking over my yard and they were huge like circus fleas. I tried everything in the yard and the only thing that worked were nematodes but it was hard getting them into the
red sand soil in 110 degree weather.
 
I decided to try Frontline Plus and that worked great for a year. Fleas were all gone. Then
one of my older dogs acted really weird and I found her acting really strange and she had bit her tongue almost in half.As she was 12 I thought she had some terrible disorder and put her
to sleep. (figured out later she must have had a couple of seizures and bit her tongue in the process)
 
The next dog to have a problem was a strong healthy 8 year old hunting hound. I was mowing and noticed he was acting a little different and panting.I thought he had been fighting with his sister as he does occasionally. I noticed about 15 minutes later he had disappeared but the other dogs were all barking in his direction. I thought they were still playing or fighting off and on. Another 15 minutes went by and I went looking for him and found him in the corner of his pen. As I approached he looked very hot and dehydrated and foaming at the mouth.I tried to pull him out of the corner and he just rolled over and started having (what must have been his 3rd seizure in 30 minutes). He never recovered and had to be put to sleep.
  
About 4 weeks later his sister who was 8 was paralyzed from the mid back down and couldnt use her back legs at all.The vet said for a big dog that happens occassionally and not much anyone could do to help her. I had her put to sleep.
 
I never really put 2 and 2 together until I read an article on the internet about Frontline . The whole article described my dogs conditions perfectly as adverse side effects. I immediately stopped using all flea/tick formulas. The fleas are back but I have not had any health problems with any of my other dogs.
 
It wasnt the dog food either. Some dogs now and then were eating the same food and some were eating completely different foods. The only common denominator was the Frontline. I have never had any dog health problems before using Frontline and I havent had any since stopping its use. The only time my dogs had problems was during its use !
 
I feel bad that I did not figure this out sooner. I loved all my dogs very much and it was awful losing them. I hope this will help others avoid the tragedy that I suffered and help others animals live long healthy lives.         

Frederick  3/30/11


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/30/11)


Please send all records concerning the following registration application:

Registration Number/File Symbol: 11556-RLU, 11556-RLL. Docket Number: EPA-HQ-OPP-2011-0013. Company name and address: Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, Kansas 66201-0390. Active ingredient: Flumethrin. Proposed Uses: Dogs and cats.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org


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(Below is a Freedom of Information Act request that I sent to the EPA on 3/31/11)


Please send all records concerning the following registration application:

File Symbol: 1007-OA. Applicant: Pfizer, Inc., 7000 Portage Rd., KZO 300-403 SW., Kalamazoo, MI 49001. Product name: CA Acaricide. Active ingredient: Insecticide and Demiditraz at 17.5%. Proposed classification/Use: Spot on treatment for dogs.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org



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(Below is a Freedom of Information Act request that I sent to the EPA on 3/31/11)


Please send me the following document:

U.S. Environmental Protection Agency (EPA). 2009. "Current Guidance for Residential Exposure Assessment for Pet Insecticide Treatments." DP Barcode 350531. W. Britton (HED) to V. Eagle (RD). January 14.

Thank you for your consideration.

Sincerely,

James TerBush
Website Administrator
www.BioSpotVictims.org



Copyright © 2002-2011 BioSpotVictims.org  All rights reserved.
DISCLAIMER:  Below are messages that I have received from others whose dogs and cats experienced adverse reactions after using flea control products.  I have no way of knowing if the information in these messages is factual, or if the products they used were the actual cause of the adverse reactions. 
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