Monthly Archives: April 2011

Frontline and its Generic Equivalent – Is It Really Safe?

29 April 2011
This article kindly republished by permission from BiospotVictims.org. [Please note: PetArmor is also a new "generic" Frontline version]
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:
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.
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.
However, this EPA memorandum from 1996 clearly states otherwise:
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.
Here are the EPA's evaluation reports for Frontline/Frontline Plus for Dogs:
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.
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):
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.
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.
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:)
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:
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:
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:
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:
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 an excellent website regarding the toxicity of fipronil:
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:
Here are the NPIC's fact sheets for fipronil:
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:
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.

Mandy Moore, Pet Safety, PetArmor and the ASPCA – What you should know

28 April 2011
I had the opportunity to see Mandy Moore while she appeared on the Rosie O'Donnell show in New York several years ago. I was very impressed with how gracious Mandy Moore was to some fans during commercial breaks of the show. Although I did not know much about her back then, I was impressed with how together she appeared to be and the maturity with which she held herself, particularly for one so young in a cut throat business. Ever since then, I have had a great deal of respect for the actress/singer. You can imagine how shocked I was when I received from a friend an invite to a "launch party" for PetArmor, a generic form of Frontline containing fipronil as the active ingredient. Here's the Save The Date teaser:

ASPCA and Mandy Moore Teaser

Notice how they don't mention PetArmor at all in the teaser. This was followed up by an email on April 12, 2011 stating: "More information will be coming soon" for the event on the 20th. On the 14th, the full media alert was released. Here are a few highlights:
MANDY MOORE TAKES THE PETARMOR™ PET PROTECTION PLEDGE, ELEVATES THE IMPORTANCE OF PET HEALTHCARE Launches Innovative Campaign, Category-Changing Animal Health Product and Announces Collaboration Between PetArmor™ and the ASPCA WHAT: Mandy Moore and the ASPCA® (The American Society for the Prevention of Cruelty to Animals®) celebrate the launch of PetArmor™, the first EPA-approved generic flea and tick treatment with fipronil for both dogs and cats, by signing the PetArmor Protection Pledge and launching a national awareness campaign to highlight the importance of animal healthcare. Together, they encourage pet owners to take the pledge and protect pets from the dangers of fleas and ticks.  PetArmor is a new, over-the-counter product that offers the same active ingredients and the same flea and tick protection as Frontline® but at significant savings.  PetArmor will considerably change the pet care aisle, making flea and tick protection more affordable and accessible to pet owners nationwide. WHY: Because about 73 million U.S. households have one or more pets, with dogs and cats accounting for about three-quarters.*(via APPA) And now, at significant savings off the leading brand name product, PetArmor promises better health for all pets. Additionally, with each person who takes the pledge, PetArmor will make a $1.00 donation to the ASPCA, up to $100,000. PHOTO OPPS: Mandy Moore signing the pledge, interacting with dogs and cats Mandy Moore discussing her commitment to protecting pets and the importance of campaign and innovative new product
Remarks and interviews with an ASPCA Veterinarian and PetArmor officials
First, Betty White goes to Sergeant's without really looking into the products she is backing and now the lovely Mandy Moore? The release sounds too good to be true - and it is. First, I already wrote about the conflict of interest that the ASPCA has in their toxicology department has with the makers of pet flea and tick treatments. This "launch" backing PetArmor is a prime example of blatantly stepping over the line. The ASPCA Poison Control Center takes the adverse reaction calls for flea and tick products. Manufacturers are required to report to the EPA. However, the ASPCA Professional Services also testify in court for these same companies and take money from these companies for their services. Most companies know which side their bread is buttered on and the ASPCA is no exception. Despite the Humane Society and almost every other major animal advocacy organization has stated that over-the-counter flea and tick products are an issue, but the ASPCA still claims what manufacturers say (which is illegal technically by the way): "Safe when used as directed." Putting the ASPCA "stamp of approval" on a pet product designed with highly toxic pesticides, and undisclosed "inert" ingredients which could be even more harmful, is reckless and lulls the public into a greater sense of false security. We already have that issue with pet parents thinking that because something is on the shelf at the grocery store or retailer, that it has some measure of safety. One of the main focal points of the PetArmor marketing strategy is getting people to sign their "Pledge". For everyone who signs, they donate one dollar to the already wealthy ASPCA coffers.

Mandy Moore Signs the PetArmor Pledge after listing the names of her pets who will now be "protected" by it.

But who is PetArmor and how did this happen? PetArmor's "on record" manufacturer brand is FidoPharm. A cutesy name for a dangerous product. It brings to mind frolicking puppies running on green grass. It's actually owned by a company called Velcera, who was in a legal patent dispute with Merial, the makers of Frontline. For some reason, at the EPA, the use of PetArmor and PetArmor Plus was registered by what they call their "affiliate" LoradoChem, Inc. officially located at Cira Centre, 12th Floor, 29202 Arch St., Philadelphia, PA 19104-2891. This address is actually registered to a lawfirm which specializes in intellectual property litigation, Woodcock Washburn LLP. It was difficult to find any information on the company LoradoChem except in reference to this generic product. That makes me think it was created by this law firm specifically to register PetArmor without raising the eyebrows of Merial, who were already involved with a patent infringement lawsuit about PetArmor. John Preston, the Chairman of the Board of Velcera, used to be the founding Executive Chairman of Merial, the makers of Frontline. He also worked for various branches of Merck. Dennis Steadman is Velcera's CEO. He was the Vice President of Merial, makers of Frontline and also served as Vice President of US Operations for Merck. The rest of the Directors appear to be venture capitalists. According to the EPA, the registration numbers for PetArmor (86230-1, 86230-2, 86230-3 and 86230-4) will all be made in India. Alternate name brands that will be the same registration numbers include TrustGard, Velcera Fipronil and Fipronil for Cats (or Fipronil for Dogs). Is it Safe? At the end of the day, most pet parents just want to know they are making the safest decision for their pets and family. You ALWAYS must be very careful when using a chemical based pesticide, especially in your home or on your pets. This is heavy-duty stuff and it is designed to kill. It kills well, but at what cost? Is fipronil safe? For years, vets who have been at conferences sponsored by the companies that produce these products have mimicked the words of their product reps. "Safe when used as directed". But they won't tell you that fipronil is considered a possible carcinogen and a suspected endocrine disruptor. They won't tell you this because they likely don't know. According to the 1996 Fact Sheet on fipronil:
Fipronil has been classified as a Group C (Possible Human) Carcinogen based on an increase in thyroid follicular cell tumors in both sexes of the rat. The increase is statistically significant by both pair-wise and trend analyses. The RfD methodology was selected for quantification because the thyroid tumors appeared to be related to a disruption in the thyroid-pituitary status... An acceptable chronic rat feeding study identified the following effects: seizures, including seizures resulting in death, decreased body weight gain, decreased food consumption and food conversion efficiency, decreased hematology measures, alterations in clinical chemistry (cholesterol, calcium, and protein), alterations in thyroid hormones, alterations in urine chemistry, changes on gross necropsy, increase in liver and thyroid weights, and progressive senile nephropathy (kidney effects)... The acute dietary endpoint of concern is acute neurotoxicity... based on decreased hind leg splay observed at this level at seven hours post treatment. The TES committee also identified short and intermediate term occupational and residential exposure end points based on a 21-day dermal toxicity study... ... reproductive toxicity was ... based on clinical signs of toxicity, decreased litter size, decreased body weights, decrease in the percentage of animals mating, reduction in fertility index, reduced post-implantation survival and offspring postnatal survivability, and delay in physical development....
And on and on. Of course the label will have the now familiar caution of "Hazardous to Humans and Domestic Animals" on it. I hope for a day when these products can be easily evaluated in a true and honest fashion by pet parents, instead of by marketing ploys and tactics. Mandy Moore, if you ever read this, I hope you take this to heart. When you think you are protecting your pets, you are doing them and yourself a great disservice to health. There are safer alternatives. Cheaper is not better. For a more information, check out this wonderful article by James TerBush of Biospot Victims on the FidoPharm and ASPCA "partnership". You may need to scroll the page to find it, but James has managed to gather a vast database of information.

Conflict of Interest in Frontline fipronil flea treatment

28 April 2011
This article kindly republished by permission from BiospotVictims.org.
(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:
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:
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:
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:
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

EPA Public Meetings: April 2011

14 April 2011
Please notice that the 2nd one has to option for you to participate by teleconference. This is primarily a meeting with registrants/manufacturers and representatives of the pesticide industry (who make pet products to combat fleas and ticks as well) so public representation is key. 1) Pesticide Program Dialogue Committee to Meet April 20-21 EPA's Office of Pesticide Programs (OPP) will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on Wednesday, April 20, from 9:00 am to 5:30 pm, and Thursday, April 21, from 9:00 am to 12:00 pm.  The meeting will be held in EPA's first floor conference center at One Potomac Yard, 2777 South Crystal Drive, Arlington, VA 22202. Information on the location of EPA's building and how to reach it by public transportation or car is available at http://www.epa.gov/pesticides/contacts/officelocation.htm.  A draft agenda is available on the PPDC webpage at www.epa.gov/pesticides/ppdc.  Agenda topics include Integrated Pest Management, Pollinator Protection, Children and Worker Risk Policy, Endangered Species Act issues, and 21st century science activities.  PPDC workgroups will present reports:  Pesticide Registration Improvement Act (PRIA) Process Improvements; Comparative Safety Statements for Pesticide Product Labeling; and Public Health.  Additional brief updates will cover spray drift, inerts disclosure, water quality issues, and the regulatory improvement initiative.   In addition, the following PPDC work groups  are scheduled to meet in sessions open to the public on April 19:   PPDC's PRIA Process Improvements Work Group will meet from 1:00-4:00 pm in Conference Room N-4830,  and PPDC's Public Health Work Group will meet from 1:00-5:00 pm in Conference Room N-4120.  Information about these work group meetings can be found on EPA's website. *********************************************** 2) PPDC Workgroup Meeting on PRIA Process Improvement On Tuesday, April 19, 2011,  EPA's Office of Pesticide Programs will host the 16th meeting of the Pesticide Registration Improvement Renewal Act (PRIA 2) Process Improvement Workgroup, a subgroup of the Agency's Federal Advisory Committee, the PPDC (Pesticide Program Dialogue Committee).  The objective of this workgroup is to identify and evaluate potential reforms to the pesticide registration process and improve its efficiency and the quality of its assessments. The agenda is available at http://www.epa.gov/pesticides/ppdc/pria/index.html. Presentations will be made by representatives from the pesticide industry on tools that they have developed for their risk assessments, software to compare labels, processes that registrants use to quality check their submissions, and their training programs to improve the quality of their submissions.  The Agency will discuss how it plans to implement a fragrance notification process, comments on the Label Review  Manuel, software being developed for registrants to draft and submit an electronic summary of a scientific study, and process improvements being undertaken by the Biopesticides and Pollution Prevention Division. The meeting will be held from 1:00 p.m. to 4:00 p.m. in Rooms N4830, on the fourth floor of the Potomac Yard North building, located at 2733 S. Crystal Drive (Two Potomac Yard), Arlington, VA.  For directions, please go to http://www.epa.gov/pesticides/contacts/officelocation.htm. Contact Elizabeth Leovey (leovey.elizabeth@epa.gov, 703-305-7328) with questions and for instructions on how to participate by teleconference.

Moderncat Studios Toys a BIG HIT!!! ~ Timmy’s Review

1 April 2011
Hai der! It mes, Timmy!!! I wanted to tells yous about a package I received frum Moderncat Studio full of all sorts of goodies! Moderncat Studio also has a bloggie called, ofcoursically, Moderncat. I was smitten frum da start wid da boxie full of goodies frum Moderncat! Evens mai housemates gots into da actin and usually dey lets mes explore mai boxies firstly.

Mai housemate Amelia helped mes opening da boxie frum Moderncat!

Mai boxie hads several toys in its, but I only wants to reviews a few of dem now and da rest in a different postie.

Da ModKickers are kickers dat is made to da highest quality and detail I has ever seen. Truly mades for kittehs and built to last. Da materials is thick and has wunderful texture, while da kicker has a bit of a twist in its so it not just a loaf. Dis means dey is easier to really sink your teeth intos and moves as yous plays wid dem. Dey also has felt ends dat makes dems incrediblys intriguing for kittehs like mes.

Large ModKicker - I loves dems!!!

Da ModKickers come in two sizes - small and large - and I wuz ables to has fun wid both of dems. As yous can sees frum dis piccie of mes, I really loves da Kickers which has designer fabrics, felt trim and is full of sooper Organic Catnip! If yous looks close, yous can see dis large kicker has a square pattern. Da pattern is actually raised and very tough, like sumpin yous might use for high quality upholstery. Da felt tip end has a wavey cut out dat just begging to bes attacked by kitteh claws and paws.

Little ModKicker from Moderncat Sudio

Da lil' ModKicker dat wuz sented to mes had a different texture. Still da same high quality fabric, but it had stripes and a different texture pattern. It wuz perfect for mes to carry around, toss in da air and ofcoursically to lick. Hee!

As sump of yous knoes, sump of mai therapy has to dos wid mes paying wid different textures. It helps mai brain learn to process different things and not bes sos sensitive to stimuli in mai environment. When I has a play session, I has lil' carpet samples of different textures spread out and cuz I sos busy playing I dun notice I is using dems. Dese ModKickers are da perfect play toy for fun and fors mai therapy wid textures.

I wuz sooper surprised at da price for da quality as wells. Value for moneys, I coulds easily use mai Kibble Moneys and buy dese. Da Large ModKicker is only $6 while da wee one is $4. Considering we has seen sump upwards of $10 for not as nice quality, dese is a steal!!! Plusly, yous can picks frum several patterns sos you wills be sures to gets an elegant, high quality toy dat fits in wid your lifestyle.

Even Gracey, da foster, hads to gets into da action!

Even Gracey, da foster who staying in mai house wid mes, hads to gets into da action. She hardly plays when anyone is watching hers - I think cuz she shy about her weight - but she coulds not resist a good play session wid dese ModKickers.

Da second toy I wants to tells yous about is da Felt Rollers. Dey looks a lil' oddish at first for a kitteh toy. Sorta like a big kitteh felt set of jacks, but oh how dey moves! Although they is felt and flexibles, dey is stiff enough not to bes wimpy - sos just right. Dey is stitched sooper well and again, dis high quality stuffs. Da nice thing too is since dey felt, dey absorbs nip sooper well and yous coulds stick em in a tub of nip for a lil' extra sumpin-sumpin.

Dese ended ups being mai favorite. No matters how I swatted dems, dey moved in an unpredictables way so I hads to keeps on swatting dems! Again, it has a wunderful texture for mes. Da Felt Rollers is multicolored and yous can pick your own colors frum several choices. Da bestest news ever is dey only costs $5 for a 3 pack!!!

Dis is mes daring da Moderncat Felt Roller to moves... Go on... I double kitteh dares yous!

Miss Kate frum Moderncat told mes dat da Felt Rollers wuz designed to mimic da movements of butterflies and I must say dat I agrees! Dis like hasing your own butterfly in da house to play wid and yet not hurt. When yous slap it down, it springs up and I pooped maiself out playing wid it.

Yous can buys da toys and oder kitteh goodies frum Moderncat Studio on der Etsy Store. When yous buy frum Moderncat, yous not only assured to get sooper high quality for a goodly price, but yous alsos doing sumpin to helps animal charities. Each month, dey chose a different Kitteh Chartity to donates tos. Der mission is to brings togethers different designers to make handmade high quality alternatives to da mass produced kitteh toys. Dey wish to enrich da lives of kittehs and owners in a positive and fashionable way, but also feel strongly about using environmentally friendly stuffs and finishes dat is kitteh safe.

Moderncat Studio is an offshoot frum da fantastically popular kitteh style blog, Moderncat, created by Miss Kate Benjamin. Yous can alsos like der pagie on Facebookie!

NOMasDay Everybudy!

*headbonks*

Timmy

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