Message Board
July 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
415.302.5371 (cell)
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(Below is a Freedom of Information Act request that I sent to the EPA on 7/1/11)
Please send me all correspondence sent to or received on behalf of Sergeant's Pet Care and/or Wellmark International regarding the protocol for a Pet Fur Residue Transfer study that was requested by the EPA and was supposed to have been submitted before the end of 2010.
The above mentioned study (and the protocol which needed to be pre-approved by the EPA) is referred to in this document:
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
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Our girl also had side effects from the BioSpot. We purchased it because it was cheap. Got a bit of a warning from the place we got it with them saying some people don't like it. Should have gone with my gut feeling instead of what we could afford.
We did one application and all seemed well. Did the second application and noticed her skin seemed to be crawling. When we touched behind her front legs and near her rump, she twitched. She also acted as if bugs or flies were bothering with a constant head jerking toward her hind quarters. She hates bugs. So we knew she was pretty distressed.
We bathed her, then I groomed her by shaving her absolutely bald then washed her again. It's been 2 weeks, and things have calmed down considerably.
Got Frontline from Costco. A bit pricey, but our girl means the world to us.
Hope Hamish is doing well now.
Kathy 7/2/11
Fawn Grove, PA
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(Below is email that Jan sent to Kimberly Nesci at the EPA on 7/4/11)
Kimberly, hello. Hope you are well. Not certain you remain at this e-mail
address as it has been quite a while since we corresponded. I am the owner
of miniature dachshund, Choe, a`Frontline' survivor. You were kind enough
to maintain contact with me for quite some time but I have not heard from
you for about one year. Choe is doing well and I am grateful he has recovered
from many years of illness and subsequent medical care following a gravely
ill prognosis four years ago after being administered a veterinary approved
dose of spot-on Frontline Wanted to send you a quick note to inquire about
public comments that were invited following the spot-on mitigation study,
which was published more than one year ago. I was feeling so hopeful
that your division would be partnering with the public to improve the controls
and follow up on subsequent sanctions for the product manufacturers, but
frankly I do not see a substantial follow-up. Ironically the public is potentially
more confused than ever with the advent of new products on the market
such as Pet Amour which touts it's EPA (apparent) approval with the
main ingredient fipronil as being cheaper than Frontline! Also, I think pet
owners would like to know, as an example, has there been any change
regarding the allowance of the ASPCA Safety Division (Animal Poison
Control Center) receiving payment from the manufacturer of Bio Spot
to "manage" their adverse incident call-in cases? If not, I'm afraid the
mitigation study would be greatly flawed. It is really time for your division
to provide an update to the public wherein we can feel a reassurance
of safety regarding commercial flea control products for our companion
animals.
I look forward to your response.
Best wishes,
Jan
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EPA Needs to Hear from You: Get Toxic Pet Products off the Shelves
Calling all concerned pet owners and families. The Environmental Protection Agency (EPA), which is in charge of ensuring the safety of flea control products, is asking for public input on whether to continue to allow the neurotoxic and cancer-causing pesticide propoxur in pet products. They need to hear from you that these products are not safe for our families or pets and should be banned.
In January, NRDC filed a petition (our third to date on the same topic) with EPA asking them
to ban the use of propoxur in flea collars. As I discussed in my January blog, the science is overwhelming. These flea collars can leave a dangerous pesticide residue on pets and is not safe for use – particularly around kids. We’ve learned that rather than listen to the science, EPA officials are waiting to hear more from the companies that make these products. In the meantime, the dangerous products remain on the shelves. We need to tip the balance and
let EPA know that there are millions of concerned pet owners and families who want to make sure that toxic products are taken off the market. EPA has opened this discussion to the
public and has a website where you can post your comments (see detailed instructions
below) until July 15th 2011.
Flea collars are designed to coat the dog or cat’s fur with a chemical residue that kills the fleas. Unfortunately, the residue is not just toxic to fleas but can also be harmful to people and pets. The pesticide propoxur is toxic to the nervous system and can cause nausea, vomiting, diarrhea, wheezing, sweating and tearing eyes. Severe poisoning can cause muscle twitching, seizures, respiratory paralysis and even death. And as I mentioned, it is a known carcinogen. Young children are particularly susceptible to these pesticides' effects because their nervous system and brain are still developing, and their ability to metabolize these chemicals is weaker than that of adults. In addition, kids often put their hands in their mouths after petting an animal, and so are more likely to ingest the hazardous residues.
Help us get these toxic products off the shelves: Follow these simple steps to tell EPA
to ban the chemical propoxur from pet products.
By July 15, 2011:
1) Go to www.regulations.gov
2) Enter the following ID: EPA-HQ-OPP-2009-0207-0018.
3) Click search.
4) On the right hand side click on “submit a comment”.
5) Type your comment in the box provided. Please be sure to let them know that you’re worried about unsafe pet products and ask them to “cancel” or ban the use of the chemical propoxur in pet products. Your name and the other information are optional.
6) Click on submit and you’re done!
7) Tell a friend - the more people who comment, the better.
Take your pet & family’s safety into your own hands: Learn more about safer methods
of flea and tick control at www.greenpaws.org. While you’re there, be sure to check out our product guide, which ranks more than 125 flea & tick products, categorizing them by the level
of their potential health threat.
This link will take you directly to the "submit a comment" page:
Thank you for letting pet owners know about this rare opportunity to tell the EPA to remove dangerous flea collars from the market! It's really hard to believe they need "public input" to help them reach a decision on this matter. You would think that banning a product that harms the nervous system of children, and injures or kills thousands of pets each year, would simply be common sense.
If you're a pet owner, please take a few minutes and submit a comment. The manufacturers
of these products don't like it when the public submits comments, but that's too bad. Our health
is more important than their profits.
James TerBush
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Grand Jury Indicts Lab Workers of Felony Cruelty-to-Animal Charges
Former workers at a product testing lab in North Carolina were indicted Tuesday by a grand jury with felony cruelty charges, on the basis of video evidence of animal abuse captured on tape during an undercover investigation.
The investigation – undertaken by People for the Ethical Treatment of Animals, an animal welfare group – produced video footage of lab workers slamming cats into cages, grabbing rabbits by the ears and throwing dogs, the AP reports.
We’ve written before about animal activists getting crafty with the law (here and here), but this is the first time lab workers have faced felony-level charges for animal abuse, PETA lab investigator Kathy Guillermo told the Law Blog.
The lab facility – formerly known as Professional Laboratory and Research Services, Inc. – shut down soon after PETA filed a formal complaint in late 2010. The group tested products such as tick and flea medications for various companies. (emphasis added)
In most animal cruelty cases, local authorities are “content” to leave the oversight of labs to the relevant federal bodies, which in this case was the U.S. Department of Agriculture, Guillermo explained.
“It’s truly groundbreaking…to get this kind of response from the District Attorney’s office,” she said.
The owner of the lab, Helen Sonenshine of Virginia, declined comment on Wednesday.
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New Jersey Attorney Gray Graifman Receives Favorable Decisions in Spot-On Pesticide Class Actions
July 7, 2011
New Jersey plaintiff's class action lawyer, Gary Graifman, recently secured favorable decisions in class actions against manufacturers of spot-on flea/tick treatments.
July 07, 2011 /24-7PressRelease/ -- Plaintiff's class action lawyer Gary S. Graifman, a partner with the firm Kantrowitz, Goldhamer & Graifman, was part of a team of plaintiffs' counsel who secured favorable decisions in four class actions involving multiple manufacturers of spot-on flea and tick treatments for pets, which were alleged to have caused adverse reactions to dogs and cats, ranging from minor to severe reactions, including death. The defendants had moved to dismiss the cases. The United States District Court for the District of New Jersey granted these motions in part and denied them in part.
The lawsuits involved multiple spot-on (e.g., applied directly to spots on a pet's body) flea and tick treatment products used on dogs and cats. Manufacturers of these products named in the lawsuits included: Merial Limited, Farnam Companies, Wellmark International, Inc., Hartz Mountain Corporation, Sergeant's Pet Care Products, Inc., Summit VetPharm, LLC, and Bayer Healthcare, LLC. These products contained pesticides such as Finopril, Methoprene, Permethrin, Pyriproxyfen, Etofenprox and/or Pyrethrin.
In April 2009, the Environmental Protection Agency (EPA) reported that there was a noticeable increase in the number of adverse pet reactions involving the spot on pesticides. The plaintiffs involved in the class actions alleged that the pesticides caused skin irritation, neurological problems/seizure-like symptoms, lethargy, weight loss and even death to their pets.
The class action lawsuits centered around four causes of action:
1. Breach of express warranty
2. Breach of implied warranty of merchantability
3. Unjust enrichment
4. Violation of the New Jersey Consumer Fraud Act
In three of the four class actions, the court granted defendant's motion to dismiss counts two, three and four above because they were subsumed under the New Jersey Products Liability Act (NJPLA). However, the court allowed the plaintiff the opportunity to amend the complaint in order to plead a product liability cause of action under the NJPLA. In the case against Farnam, only the unjust enrichment count was dismissed.
By only partially granting the defendants' motions to dismiss, the court has allowed the putative class actions to go forward. The plaintiffs' claims involving breach of express warranty were allowed to proceed in the litigation. This is a victory for the named plaintiffs in these cases as well as the class of people who purchased the dangerous products and whose pets were injured by them.
For more information about the spot on flea and tick removal class actions, or to speak with class action attorney Gary S. Graifman, please call 800-660-7843 or visit www.kgglaw.com. Since 1975, Kantrowitz, Goldhamer & Graifman, P.C., has offered full-service, quality legal representation for clients in New York and New Jersey.
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My family recently purchased a chocolate lab from a breeder. The first 2 days he was a typical 10 week old puppy. We took him jogging and walking on the leash and he did great, but after we gave him his first bath and applied the Biospot on him we slowly saw a change in his behavior. At first I thought he was just being lazy and decided not to walk on the leash any more. If we had it on him he would just lie down. He also just wanted to sleep all day and not play like he did the first couple of days. He would just go potty and plop back down on the grass or walk really slow and lazily. After trying to figure out if we just had a lazy dog I started to think about the reviews I read about another product that made peoples dogs lethargic and I decided to read up on Biospot. I found out it had some of the same side effects and immediately gave him a bath in Dawn detergent. After the bath our precious baby boy was back running around and acting like a puppy should. We didnt expect the change so quickly but were happy it helped. Thanks to websites like this we have our puppy back.
Tressie 7/10/11
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this stuff has just killed my cat, made for cats, spot on flea and tick control. alley cat we called him, was an abandon kitty, we had him a short time, but a great kitty. i feel so bad by using this product my kitty has died. i have three other cats, thank god i did not use this stuff on them too, my hubby and i are so heart broken. please have this stuff taken off the market. heart broke
joan 7/13/11
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I came across the BioSpotVictims site while I was searching for the best flea and tick treatment for a dog with sensitive skin. The site grabbed my attention because my dog's adverse reaction to BioSpot was the reason that I was searching for a new product. My dog is a 4 year old silver lab. He has very sensitive skin; short hair and white skin underneath make him susceptible to many things that could irritate his skin. We had used Biospot on him for the last 2 years. It was recommended to us by his breeder. However, last month when we put it on him (first time for the year) he freaked out when we applied it, but we were not too concerned figuring he just didn't like us squeezing it on his back. The next day I noticed him scratching his neck/back close to where it was mainly applied. By the next day he had scratched all the hair off in that spot and his skin was raw and appeared to have clear discharge coming out of it. I kept the area clean and treated to avoid infection for the next few days. Around that same time I started to notice that his hair seemed patchy, like it was falling out. Over the next week he lost almost all of his hair on this back. It was so odd and he had never experienced this type of shedding before.
As I read the story on the website, it made sense. I am almost certain that BioSpot caused this to occur. I can't believe that a product like this is on the market. How horrible.
I just thought I should take the time and share my story. There are probably so many other people that have experienced odd occurrences in their pet after using a product like this and never put the two together. Thank you for your dedication to educating people like me about the harm these products can cause.
Tracy 7/14/11
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(Below is email that I received from the EPA on 7/14/11)
Dear Mr. TerBush,
Thank you for your recent inquiry regarding the status of EPA’s Response
to Comments on the evaluation of pet spot-on products. The EPA is
currently in the process of reviewing the numerous comments received
before determining a response (or its next course of action, or next
steps). The Agency’s time frame for completing responses to public
comment always depends on the nature of the comments and depth of the
review required to provide a thorough response. We are planning to
complete the Response to Comment document by the end of this summer and
will be posting our response on our website www.epa.gov/pesticides and
in the docket. In the meantime, all comments received on EPA’s pet
spot-on analysis and mitigation plan can be viewed online at
www.regulations.gov in docket number EPA-HQ-OPP-2010-0229.
Thank you again for your inquiry.
Best regards,
Wade
~ * ~ * ~ * ~ * ~ * ~ * ~ * ~ * ~ * ~ * ~ * ~ * ~
Wade Britton, MPH
Acting Coordinator of Pet Spot-On Product Mitigation
Registration Division
Insecticide-Rodenticide Branch
Office of Pesticide Programs, US EPA
(703)308-0139
(Below is email that I sent to Wade Britton on 7/14/11)
Dear Mr. Britton,
Thank you for the reply. As you know, the comment period for the EPA's pet spot-on investigation and proposed mitigation plan ended on May 17, 2010. It should not have
taken more than a year to issue a timely response, but if the EPA requires more time to
provide a thorough response, I will certainly look for it at the end of the summer.
I trust that you will do your best to meet that schedule. Any delay beyond that would not
inspire confidence in the system.
Sincerely,
James TerBush
Website Administrator
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On Tues. evening 7/12/11, I administered a half vial of Biospot on my schnauzer and the other half on our dachshund Lilly. The next evening I notice that her tail was down and hanging sideways. On Thurs.at around 10:00 AM. I went to pick her up and she yelped. By 11:00 AM I could hardly touch her. I took her into the bathroom and bathed her in a mild soap. I was very liberal in the use of it. I rinsed her for about 10 mins in cool water and took her out and dried her. I still am having difficulty lifting her without her yelping. She is very lethargic and not eating right. I don't have lot of money so the vet is questionable. The other dog had little to no problem. I am having to give her ice cubes to keep her hydrated. Her urine is clear and she has had a couple of bowel movements. I guess what I want to know is is the worst over? She seems to be doing better. However, I feel sure that she has a ways to go. This Biospot is poison. She has never been this sick. I won't use it again on either dog. Any additional info would be helpful.
Robert 7/15/11
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Below are comments that I submitted to the EPA on 7/15/11 concerning the NRDC's
petition supplement to remove propoxur pet collars from the market.
James TerBush
Website Administrator
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I used Sergeant's Flea control on my sweet kitty, Macie Rose & now 2 days
later she is DEAD! Macie was my sweet Exotic Persian kitty who I loved
dearly. She was only 3 years old & Sergeant's products killed her.
Connie 7/17/11
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Federal Regulators in Bed with the Pesticide Industry
Last week, a letter was submitted to the EPA on behalf of Sergeant's and Wellmark concerning the safety of their propoxur-based pet collars. The letter referred to a recent study they funded, which found that pets wearing their flea collars do not pose any risks of concern to children. The study had been reviewed by a company called Exponent.
Here's an interesting article that was published in February concerning Exponent's role in refuting research that had linked certain pesticides to Parkinson's disease:
Excerpts:
"The company, Exponent Inc., based in Menlo Park, Calif., is known for its scientific research on behalf of corporate clients facing product liability concerns."
"Exponent is listed as a member of CropLife America, the trade group that represents pesticide manufacturers, and also has worked regularly for Syngenta, which makes paraquat."
"Arthur Caplan, who runs the University of Pennsylvania Center for Bioethics, finds the arrangement disturbing. 'If you have a private sector entity that has no interest and is just giving general money for support, that's not a conflict,' Caplan said. But when a company or industry has 'a stake in the outcome,' or offers 'support which is difficult to track, when it's not very transparent, it makes for trouble...I don't think every private dollar is tainted, but at the same time, when you're in areas where somebody has a dog in the fight, that's going to raise appropriate questions about conflicts.' "
"Science-for-hire firms, Caplan says, must by nature be attentive to the needs of their corporate underwriters."
"Caplan is not alone in his view. In his 2008 book, 'Doubt Is Their Product: How Industry's Assault on Science Threatens Your Health,' David Michaels wrote, 'While some may exist, I have yet to see an Exponent study that does not support the conclusion needed by the corporation or trade association that is paying the bill.' "
Recently, I learned that Debra Edwards -- the former director of EPA's Office of Pesticide Programs -- is now the Senior Managing Scientist at Exponent's Health Sciences Center for Chemical Regulation and Food Safety (interestingly, her name appears to have been removed from their website).
Debra Edwards had a long career at the EPA. Besides being Director of OPP, she
held several other leadership positions, including: Director of the Special Review and Reregistration Division, Director of the Registration Division, Associate Director of the
Health Effects Division, Chief of both the Risk Characterization and Analysis and Chemistry/Tolerance support branches within the Health Effects Division, which she
noted in her testimony before the House Agriculture and Natural Resources Committees
on May 3, 2011:
Her testimony before the committees had been arranged by the Chemical Producers & Distributors Association, of which she is an associate member:
Debra Edwards, along with Steve Bradbury (the current Director of EPA's OPP), are
scheduled to address the CPDA's Annual Meeting this week at the Don CeSar Beach
I find all of this to be deeply troubling and worthy of an investigation.
James TerBush
Website Administrator
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(Below is a Freedom of Information Act request that I sent to the EPA on 7/18/11)
Please send all records, including correspondence between EPA and the Chemical Producers & Distributors Association (CPDA), in regards to OPP Director Steven Bradbury's upcoming guest appearance at the CPDA's 2011 Annual Meeting in St. Pete Beach, FL, on July 19, 2011.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
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Sergeant’s FiproGuard Plus Recalled Due to Patent Infringement
OMAHA, Neb.--(BUSINESS WIRE)--Sergeant’s announced today a return and exchange of all fipronil-methoprene products including those sold as FIPROGUARD™ Plus, Pronyl OTC™ Plus, EctoAdvance™, Spectra Sure™ and Prefurred™ because they infringe Merial's US patent 6,096,329 entitled “Insecticidal combination to control mammal fleas, in particular fleas on cats and dogs.”
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Merial Introduces New Product to Deal With Expiring Patent
Burgeoning Tick Problem
The Vet Blog with Dr. Eric Barchas, DVM
I currently am attending the American Veterinary Medical Association’s annual convention.
Veterinary conventions are singular things. They are populated by by three distinct groups of people, each of whom can be recognized from a distance. Veterinarians tend to be poorly dressed and to avoid eye contact with others out of fear that they might accidentally end up cornered by a drug company representative. Vet students and vet techs can be identified by the ginormous bags of schwag (doled out by drug reps) that they tote about. Drug reps actively seek eye contact and conversation; they also are the only people at the conference who could reasonably be considered by an independent observer to be well dressed or attractive. The drug reps are highly concentrated in the convention’s exhibit hall. I avoid that snake pit if at all possible.
Everywhere at the convention are advertisements. No advertiser is more prominent than Merial; an ad (shown above) for their new flea and tick preventative, Certifect, features prominently on the back of the note book that came with my convention materials.
It is an open secret that Merial’s patent on fipronil (one of the active ingredients in Frontline Plus) is expiring. Cheap generic versions of the product will soon (or may already have) hit the shelves. Certifect appears to be Merial’s response to the market share threat posed by this matter.
When I looked at the ad above, three things jumped out at me. First and foremost was the notice on the lower left portion of the box: DO NOT USE ON CATS. I recommend Frontline Plus for tick control precisely because it is safe for cats. Generally speaking, if something isn’t safe for cats, then I don’t want to put it on my dog (let alone a cat).
The second item that caught my eye was that the ingredients of the product aren’t listed on this or any other ad. The third thing, of course, was free lunch. I went to the lecture.
At the lecture, which was very well attended (free food is notoriously good for boosting lecture attendance), a point was made that tick populations are increasing. It was mentioned that ticks carry all sorts of nasty diseases, and that good tick preventatives are in dogs’ best interests. No mention was made of any expiring patents.
Then, a veterinarian from Merial was pleased to introduce Certifect. And finally, I found out what was in the stuff. It contains fipronil and S-methoprene (already in Frontline Plus) as well as amitraz (a different sort of anti-creepy-crawly agent). Together, the two (fipronil and amitraz; S-methoprene is for fleas) have potentiated activity against ticks.
This is not the first time that amitraz has been used as part of a flea and tick preventative. It was an ingredient in ProMeris, which recently was pulled from the market due to concerns about immune system disease (although amitraz has not been implicated in these issues; it is an old-school product that has been in use for other purposes such as the treatment of puppy mange for quite some time — prior to its withdrawal from the market, ProMeris showed great promise for the treatment of refractory puppy mange).
I doubt that Certifect will cause immune system disease. Perhaps it even will help with puppy mange (although if any studies showed it did the Merial rep surely would have mentioned them). And, relative to the nasty agents that are present in other DO NOT USE ON CATS products, amitraz is positively benign.
At the end of the lecture, one of my fellow conventioneers asked why Certifect cannot be used on cats. The answer she received was that the product has not been tested on or approved for use on cats.
This piqued my curiosity. It almost sounded like the stuff is safe for cats. I work at an emergency hospital. I know, as sure as death and taxes, that once Certifect hits the market people are going to start accidentally applying it to cats.
I usually don’t ask questions during lectures, but I couldn’t stop myself.
My query, “but is it safe for cats?” (shouted from the back of a large and crowded room) drew quite a bit of laughter. The vet from Merial refused to answer my question — he simply reiterated that the product has not been approved for use on cats.
Fortunately, another rep swooped in to talk to me personally. For my fellow veterinarians, according to the Merial rep: amitraz is unlikely to cause toxicity unless orally ingested (and, as all vets know, cats can orally ingest anything that is put pretty much anywhere on their bodies; they are super limber). If orally ingested, it can cause signs of sedation similar to those caused by alpha-2 agonists such as dexmedetomidine. The sedation supposedly can be reversed with atipamezole.
For any person who accidentally has applied Certifect on his or her cat: call your vet immediately.
For the record, Certifect may actually have some potential. However, I don’t live in an area where ticks are much of a problem, and my pal Buster hasn’t had a tick for years. For now I’ll stick with Frontline Plus (or perhaps a generic equivalent).
Please pardon the poor quality photo in this post; I’m out of town, with limited equipment.
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Certifect vs ProMeris for Dogs and Amitraz – is Everything Old New Again?
By Dr. Greg Magnusson
Certifect is like Frontline Plus but with amitraz added?
By now, hopefully all pet owners know that ProMeris for Dogs is no longer being manufactured by Pfizer, after a study suggested it might cause Pemphigus foliaceus, an immune system mediated skin disease, in some dogs.
ProMeris contained a combination of metaflumizone and amitraz. It is unclear if the amitraz portion of ProMeris had anything to do with the Pemphigus. We do know that amitraz on its own, which has been used for years and years in products like MitabanⓇ, cause no such diseases.
In my personal and clinic experience, ProMeris smelled HORRIBLE, ate paint off of surfaces if a dog wearing it happened to lean against something, and caused local skin reactions including scabbing and hair loss in about 2% of all dogs receiving it. Was it the metaflumizone? Or the carrier that the metaflumizone and amitraz were in? Did they make it with used motor oil or something?!
Anyways, none of this was Pfizer’s fault, since they gained control of ProMeris when they acquired Wyeth / Fort Dodge Animal Health in 2009. Pfizer also makes Revolution, a prescription topical that prevents fleas and heartworms, and is a fabulous drug. Obviously Pfizer thinks they can sell more Revolution than ProMeris. Hooray Pfizer! Good riddance to ProMeris!
So now, a competing company – Merial, makers of Frontline Plus – is coming out with a drug they call Certifect, advertised as “a better way to detach and kill ticks”. Certifect is essentially modified Frontline Plus with our old friend amitraz added.
So, if ProMeris sales fell flat, I wonder what makes Merial think Certifect will fare any better?
Amitraz and therefore Certifect must be used carefully, and only in selected patients
Veterinarians have been concerned about the safety profile of amitraz for years. It’s a powerful drug, and does lots of great things if you use it carefully.
The pharmacological action of amitraz is not well understood, but it is a monoamine oxidase inhibitor (MAOI) in mites and may have effects on the central nervous system of susceptible organisms. Amitraz can cause a significant increase in blood sugar levels in patients, and should not be used on “fragile” diabetics. In cats, we know that amitraz ingestion (ie: from self-grooming) can cause sedation similar to that caused by alpha-2 agonists such as dexmedetomidine (a common veterinary injectable sedative).
Other, much more concentrated amitraz containing products have included instructions like:
1. Flammable until diluted with water
2. Do not stress animals for at least 24 hours after application.
3. Protect exposed skin with rubber gloves, etc.
4. Wash hands and arms well after application to animal.
5. Avoid inhalation of vapors.
6. Animals treated may exhibit signs of sedation; if animal is un-arousable or sedation persists for longer than 72 hours, contact your veterinarian.
7. Safety of amitraz has not been demonstrated in dogs less than 4 months of age.
8. Reproductive safety has not been established.
9. Toy breeds may be more susceptible to CNS effects (transient sedation).
10. If treating around eyes, use an ophthalmic protectant (e.g., petrolatum ophthalmic ointment) before treating.
11. Other adverse effects include: dizziness, slow heart rate, vomiting, diarrhea, hypothermia and high blood sugar levels.
12. Can be toxic to cats.
13. May interact poorly with selegiline (L-deprenyl, AniprylⓇ, used for cognitive dysfunction in dogs), or tricyclic antidepressants (amitriptyline, climipramine / ClomicalmⓇ).
Merial should address safety of amitraz-containing Certifect
As you might be able to tell, I was not a fan of ProMeris. I never did sell it.
So here’s my problem. Nobody denies that amitraz is an outstanding anti-tick drug. I get it, that’s cool, it’s good stuff when used gently and with veterinary supervision, on certain young healthy dogs.
But shouldn’t Merial learn from the errors of predecessors and BEGIN their marketing campaign by reminding veterinarians about the bad things that amitraz can do? And instead of a campaign called “A New Standard in the Fight Against Ticks That May Carry Disease” perhaps go with something more like “If Frontline Plus isn’t repelling and killing ticks fast enough for your liking, please ask your veterinarian if it would be safe for you to try Certifect."
Or how about just “it’s not as bad as ProMeris, we promise!”
Pet owners, understand that Certifect doesn’t contain any “new” molecules, only old ones in new combinations. Many of the old warnings may therefore still apply.
None of this is intended as directed against Merial, which as a company has created some VERY helpful veterinary drugs for many years. (Ivomec / Heartgard, Frontline, Frontline Plus, Oravet, Previcox, and some truly outstanding vaccines).
I just wish that the general public could be warned about known, potential hazards BEFORE Certifect gets much further into its launch. By the time most people Google Certifect and find this post, the product will probably be all over the marketplace.
If you accidentally put Certifect on your cat, even though the label specifically told you not to, please contact your veterinarian right now.
As for Leo’s Pet Care and our clients, I will recommend a common-sense approach: wait for others to try it first. Once Certifect has been on the market for a year or two, and a more complete safety profile has been determined, then you can consider putting this on your young, healthy dogs, if ticks are a big problem where you live.
If that’s not your dog, maybe just stick with good ol’ Frontline. Or, better yet, instead of old-school Frontline or amitraz-containing Certifect, buy some Vectra 3D from your veterinarian.
___________
NOTE: I do NOT recommend using "good 'ol Frontline" or Vectra 3D (which, by the way, was created by Hartz).
James TerBush
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(Below is a Freedom of Information Act request that I sent to the EPA on 7/21/11)
Please send me the Registration Jacket for EPA Reg. No. 65331-7 (Certifect for Dogs, registered to Merial Limited).
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
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More Frontline Plus Generics to Exit Market Due to Patent Issues
In a move that will apparently remove most Frontline Plus generics (fipronil-methoprene combinations) from the market, Sergeant’s Pet Care Products Inc. of Omaha, Neb., plans to voluntarily remove its various products, citing patent infringement.
Sergeant’s is initiating a return and exchange of all fipronil-methoprene products sold in a broad range of channels, including those sold as FiproGuard Plus (pet specialty retail), Pronyl OTC Plus (mass market retail), EctoAdvance (veterinary channel via Meridian Animal Health), Spectra Sure (direct to consumer via Durvet) and Prefurred (professional pest control market) because they infringe Merial's U.S. patent 6,096,329.
Sergeant’s has not yet disclosed specifics of the return and exchange program or its future plans for marketing flea and tick control products combined insecticides with insect growth regulators (IGR).
Fipronil-based generics not containing methoprene will remain on the market. The inclusion of the IGR is designed to help prevent reinfestation of the pet by killing pests at the egg and larva stage, not just the adult fleas and ticks that Fipronil kills.
The action follows a continuing legal battle between Merial and Cipla and Velcera regarding patent claims surrounding their fipronil and methoprene flea-and-tick control products. In June, a U.S. District Court for the Middle District of Georgia ruled that sales of PetArmor Plus manufactured by Cipla Ltd. and Velcera Inc. infringed on Merial’s patents covering its flea-and-tick product FrontlinePlus. Cipla and Velcera officials say they will appeal the verdict and an order to remove the products from the market was stayed 60 days pending the appeal.
In January, Sergeant’s announced an agreement with Japanese company Sumitomo Chemical Co. Ltd. for the licensing of Sumitomo’s patent U.S. 5,567,429 in association with the development, manufacture and sale of a composition combining fipronil with an insect growth regulator to eliminate and prevent pests on dogs and cats.
The January announcement said the license would permit Sergeant’s to utilize the patent in the manufacture and sale of spot-on pesticidal compositions that combine fipronil with an insect growth regulator such as methoprene or pyriproxyfen.
Sergeant’s then launched Fiproguard Plus and Pronyl OTC Plus (as well as base versions with just fipronil) at Global Pet Expo in Orlando in March.
The Sumitomo patent covers the combination of an IGR with a fipronil-class insecticide to control a wide variety of pests, including both “sanitary pests (e.g. flies, mosquitoes, cockroaches and mites), and blood-sucking pests such as ticks, fleas, etc. which are parasites on animals (e.g. pets).” The patent also claims effectiveness against ants, crickets, hornets, aphids, stink bugs, beetles, weevils, butterflys, spiders, millipedes and silverfish. However, the Sumitomo patent does not refer to a spot-on delivery system, but discusses, in the case of pet use, a pest-controlling collar with the caveat that “the present invention is not to be interpreted as being limited to these examples only.”
By contrast, the Merial patent emphasizes the use of fipronil as the most likely insecticide, the use of it to control fleas on cats and dogs, and the delivery of it in a spot-on type formulation.
Meanwhile, Merial this week launched its newest flea and tick product for dogs, Certifect, at the American Veterinary Medical Association convention in St. Louis.
Certifect essentially combines Frontline Plus with a small amount of amitraz, another pesticide effective against ticks, that results in a faster killing of ticks (begins within 6 hours and can kills all ticks within 18 hours, according to Merial) and, unlike other pesticides, the detachment of the ticks before they die. Both the quicker kill and the detachment help prevent the spread of disease to dogs from the ticks, according to Mike Murray, DVM, technical marketing director for Merial.
Apparently the combination of amitraz and fipronil have a synergistic effect that makes the compound more effective than either compound alone, Dr. Murray said.
He said that Certifect is not designed to replace Frontline Plus and emphasized that flea and tick control is really about disease control, not pest control, and that pet owners should consult their veterinarian for the proper product for their situation (including an assessment of existing tick risks).
Also, because Amitraz is a monamine oxidase inhibitor, people taking MAOI-containing medications (including certain antidepressants that can also be used to treat Parkinson’s and social anxiety and prevent migraines) should be especially cautious when handling the product.
Certifect will be more expensive than Frontline Plus and is not for use of cats, although safety studies in Europe did not indicate adverse effects on cats in homes with treated dogs.
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Another story about this awful product. We live in Minnesota where there
are ticks in abundance.
We have been giving our 4 dogs BioSpot for four months now. On July 1, 2011
our little Yorkie-Poo, Elly (4 years old) became sick and seemed to have
symptoms of an injured back. She lost her spunk, and struggled to walk.
She was in a great deal of pain.
We took her to the vet and they did a blood test and thought she had low
grade Lime's Disease. Sent us home with med's to treat this. The next day
she was even sicker so we took her back to the vet and she was given a
steroid shot, hydration shots and pain pills. At this time the vet was
leaning toward something wrong with her back.
One week later she was even worse. Back to the vet and x-rays were taken of
her spine. Found nothing on the x-rays. Again we were sent home after
another steroid shot, hydration shots and pain pills.
Three more days go by and our poor little dog is going into shock, in a
great deal of pain and having seizures and close to death. The vet was
closed so we took her to another vet. She was having a seizure in the vets
office and we were told it did not look good for her. They did another x-ray
on her back, did a full blood work on her which was over $600.00. She got
another steroid shot, hydration shots and a shot for pain. We took her home
thinking she would not make it through the night. We were just heartbroken
about our little doll. Something the vet said was, there is neurological
problems. We were told to return the next day to see what the blood work
found. He had no clue what was wrong with her at this point. So at this
time, three Vets have seen her and none of them could figure out why she is
so sick.
Still not knowing what the heck was wrong with her, I got on a pet md web
site and looked up neurological and one of the articles was on the flea and
tick meds. Mentioned was Permethrin so I immediately checked the box of
BioSpot. Oh my God there it was. So the next day we told the Vet about
this product we were putting on Elly. He told us about Permethrin and told
us to wash her in dish soap and we were given meds to help detoxify her. He
also told us about this website. She had another x-ray because she moved on
the previous one. This x-ray showed nothing wrong with her back. Finally
she has some hope. I was still disturbed about the loss of coordination she
is experiencing. Not knowing if it will go away or if she has to live with
Parkinson Disease symptoms.
Today she is starting to feel better. We are noticing she is now able to
walk without falling down, seems not to be in pain, and has gotten her
appetite back. Her head bobbing has diminished. We are praying that there
will be no lasting effects on her. This little dog has been suffering for
three weeks with no relief because we had no idea what this product did to
her. Pure greed on the manufacturers who make this product. They know what
this stuff does to our pets. To most of us they are not just pets but our
family.
We have washed all dog blankets, collars and all the dogs. We will NEVER
put another flea and tick product on any animal we own. Hopefully this
horrible product is removed from the market. We had no clue this was what
almost killed our dog. Thank God I did some research and we able to help
the vet figure out what to do to save her.
My husband is planning on joining the Class Action Lawsuit We have spent
$1,500. on her so far and we still have more vet visits ahead of us.
Jean and Stan 7/23/11
Wyoming, Minnesota
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A Mr. Nader Is Calling, and He Wants a Refund
A FEW weeks ago, Ralph Nader rang.
Now, if you supported Al Gore and are still furious about Mr. Nader’s role in the 2000 presidential election, the mere mention of his name may make you boil.
Well, boil somewhere else.
This, if you need a reminder, is not a column about politics. It’s about consumer justice, and it is hard to think of anyone who has worked more tirelessly and more effectively for that cause than Ralph Nader. For the Haggler, a parvenu in the field, hearing from this guy was like a weekend fiddler’s getting a call from Mozart.
He phoned to tell a story, and it turned out to be a good one, with an interesting moral. It goes like this:
In March, Mr. Nader was scheduled to give a press conference and speech in Knoxville, Tenn. He’d bought two round-trip tickets — one for him, one for an associate — from Washington, on US Airways, for $1,380 apiece.
On the day of the event, the forecasts were for severe thunderstorms and tornadoes, and Mr. Nader decided that it was possible his flight would be canceled. So he opted to jump in his car and drive.
He made his engagements in time and incurred two $150 cancellation fees from US Airways. But he didn’t get the rest of his money back. Instead, the airline offered credits that could not be transferred and had to be used within a year. Otherwise, they would be forfeited.
Suffice it to say, this did not please Mr. Nader.
“Could any dictatorship be more efficient?” he asked the Haggler. “The airlines have been pursuing this forfeiture thing for a decade now. It’s like printing money.”
So Mr. Nader wrote to US Airways and demanded a refund. The airline said no. Mr. Nader, you will not be surprised to learn, did not like that answer, and he escalated his campaign with calls.
About now, roughly half of readers are thinking some variation of the following: “Wait a minute. When Nader bought those tickets, he agreed to a contract, which no doubt stipulated all of the particulars that he later objected to. Too late, pal. If you didn’t like the terms, you shouldn’t have purchased that ticket.”
The Haggler hears you. And he’d like to respond with yet another story.
This one takes place in 1972, when a man — let’s call him Ralph Nader, because that was his name — bought a plane ticket from Washington to Hartford for a speaking engagement.
Unfortunately, the flight was overbooked and Mr. Nader was bumped. He sued, alleging fraudulent misrepresentation because the airline had not disclosed its policy of deliberately overbooking flights. The case ultimately landed in the Supreme Court, where Mr. Nader prevailed.
The $25,000 in damages he was originally awarded were ultimately whittled to nil. But his primary goal wasn’t to get rich. It was to change a policy. After his victory, airlines began holding those impromptu auctions in which passengers are asked if they will take a later flight in exchange for a goodie — like a credit for a round-trip ticket.
IF you’ve ever nearly been bumped from a seat but got on board courtesy of an instant auction, you can thank Mr. Nader. If you have ever raised your hand and said, “I’ll take the later flight and the goodie,” you can thank Mr. Nader, too.
The point isn’t that we should all send the man a card. The point is that just because the airline has a policy that it has turned into fine print doesn’t mean that it’s fair, or that you can’t object to it. If you object loudly enough, and in the proper places, you might even change the fine print.
It is worth noting that the airline that Mr. Nader was to fly that day in 1972 was Allegheny, which later became US Airways. But if there was any institutional memory about this episode at the carrier, which is now based in Tempe, Ariz., it was not evident. In March, Mr. Nader sent a letter to its chief executive, Doug Parker, who, according to Mr. Nader, did not respond. Then Mr. Nader called Mr. Parker twice. Nothing.
“It’s like trying to reach Fort Knox,” he said. “You can’t possibly get these guys.”
Question: How is it possible that the name “Ralph Nader” did not ring the equivalent of air-raid sirens at the office of US Airways?
Mr. Nader eventually spoke to an assistant to the general counsel of the airline and mentioned three words: small claims court.
That did it. On June 6, Mr. Nader received a letter from a customer relations rep named Kristy Garden, who wrote, “After review of your file, due to the circumstances and as a one-time courtesy, I have authorized a refund of your tickets.” And he got back his $300 in cancellation fees.
The Haggler also heard from Valerie Wunder, a spokeswoman for US Airways, who said it evaluated customer requests “on a case-by-case basis and so were able to resolve Mr. Nader’s issue.”
Now we come to the moral of the story.
“Small claims court is an unknown venue to most people,” Mr. Nader says.
In recent years, small claims courts have become the favorite places for collection companies to file for default judgments on an assortment of credit card and auto loan debts. But that was not their original purpose. When they blossomed in the 1960s, they were meant to be consumer-friendly places for disputes under a certain ceiling — today, $5,000 or so is typical.
“I read a lot of consumer books, and almost all of them completely ignore small claims court,” Mr. Nader says. “Few people know how simple the forms are, how accommodating the judges are. A lot of them are even open at night.”
The Haggler hears a couple times a month from people who have just been to small claims court, and usually they are writing to chest-thump about their victories. Why mention that? Because otherwise you might think this US Airways episode proves only that the airline was smart enough to dodge the P.R. calamity that fighting Mr. Nader in court would surely have been.
Not so. To win in small claims court, or, as happened here, to triumph just by threatening to file there, you don’t have to be named Ralph Nader.
Though it couldn’t hurt.
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(Below is a Freedom of Information Act request that I sent to the EPA on 7/29/11)
Please send me the most recent human health risk assessment for fipronil (DP Barcode D360652, D. Drew, 9/22/2009).
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
Hello James,
I came across your website, and am experiencing something similar. My dog Buster was given K9 Advantage a month ago, and has had paralysis in his back legs since then. I called Bayer, and they gave me the same line they give everyone. "Our product is so safe your dog could eat it". Have you heard of similar stories, and have you heard how long it takes for the dogs to regain the use of their back legs? I'm desperate for information!
Thanks,
Annie and Buster 7/30/11
Hi James,
Thanks for your response!
Our vet ran blood work and also did x rays on his legs and spine. He was sent home with steroids and antibiotics in case he has meningitis or any other infections. The vet could find no other reason for the paralysis, and actually suggested it might be from the flea treatment, which he had received a couple of days prior. Its been a month, and no change in his condition. We have been referred to a neurologist to see if there could be any other cause for his condition.
Again, thanks for your response!
Annie 8/3/11
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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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