Message Board
June 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)
***************************************************************************************
(Below is email that I sent to Kimberly Nesci at the EPA on 6/1/11)
Hi Kimberly,
Any word on when the response to public comments regarding the pet spot-on evaluation
will be released? It seems like it's always within the "next couple months."
Could you please let me know how long the EPA has to respond to public comments? (ie.
12 months, 18 months, 24 months, etc.)
Thanks,
James TerBush
Website Administrator
***************************************************************************************
(Below is a Freedom of Information Act request that I sent to the EPA on 6/3/11)
Please send me the EPA's Response to Public Comments regarding its pet spot-on evaluation, the results of which were announced on March 17, 2010.
If the requested document is not completed yet, please let me know when it will be
released.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
My dogs were given a bath last week with BioSpot shampoo....shortly after they
started shaking uncontrollably. My small Papillion was rushed to the vet two days
after her shampoo where I was told my dog was suffering a very bad reaction and
had to be put on muscle relaxants to try to control the shaking. My larger dog was
fine within a few days. I called Biospot today they told me to send them the upc from
the bottle and the vet bill/record for reimbursement consideration and transferred
me to the ASPCA Safety Division. Well they informed me that this had nothing to
do with their product, their TOP vet Dr. Haze told them that there were not high
enough levels of toxins in their shampoo and something else was wrong with
my dogs. She even went as far to tell me that the rain must have sprouted wild
mushrooms in my yard and that the dog ate them! They are IDIOTS! She weighs
only 7 pounds and is still shaking and still on her meds. The vet told me to wait a
week and she should be fine....I am two days away and she is still not FINE! I need
to find a higher means to complain.....I told them they needed a warning label on
their product as I followed the directions and am capable of giving my dogs baths!
She insisted they did not need a warning label any further than what is on there
because it is not toxic. I beg to differ! I told her she did not understand that my pets
are considered my children and would be devastated if something happened to
them and was worried about long term effects, she stated again it had nothing to
do with their product and she was sorry but I had to find out what it was the dog got
into. The dog got into a bath! As a routine we give the dog a bath, put on their frontline,
and give them their heartworm pill....we have being doing this for years....this time I
changed shampoos, only difference! Vet said I picked one of the worse ones and
nothing else I did would cause the problems she is experiencing. Now how do I
convince the uncaring individuals at Biospot - and worse - the ASPCA who is
SUPPOSED to care about my pets wellbeing? They said they never had a
complaint...really?
Cherie 6/6/11
Hi Cherie,
Thank you for taking the time to write. I am very sorry to hear about your dogs.
The ASPCA Safety Division (Animal Poison Control Center) is actually paid
by the manufacturer of Bio Spot to "manage" their adverse incident cases.
In other words, they are paid to make problems go away. The APCC also
offers the manufacturers who contract their services consulting on legal
cases and product liability. That is a serious conflict of interest!
Unfortunately, if you gave your dogs Frontline, a heartworm medication, and
the flea shampoo bath at the same time, the reaction could have resulted
from the concurrent use of those products. All of those products contain
pesticides which can potentially interact with each other.
Please contact the National Pesticide Information Center (NPIC) and let
them know what happened (they maintain a database of adverse incidents
frompesticide products for the EPA). Their number is 1-800-858-7378.
I hope that your dogs quickly recover.
Sincerely,
James TerBush
Website Administrator
Thank you so much for your quick response...we do this routine every month
and have never had a problem with other shampoos...I do know it is from
that but you are right - since we did all three now I cannot prove which
did it, although their shaking started right after their baths and the
other meds were not given for two days after. The vet said it was not a
problem either, but I understand your point. I will contact the other
number you gave me. I wish I could have the shampoo tested by a lab to see
if the levels are in fact higher than they state! Something is seriously
wrong with this system, I never imagined giving my dog bath would result
in a 7 pound dog shaking uncontrollably for a week now! I think the
biggest thing is that this shampoo should not be for dogs under a certain
size even though it clearly states it is geared towards dogs and puppies.
Lesson learned, I only hope my dog is alright in the end. The other seems
fine now, but he is much bigger than her.
good luck in your endeavors! I, for one, will not be using Biospot again!
Cherie 6/7/11
Hi Cherie,
I believe that your dog's reaction was most likely caused by the Bio Spot
shampoo. It certainly is toxic enough to cause the symptoms that you
described, especially in small breed dogs.
Here is the Material Safety Data Sheet for it:
While the percentage of pesticide in it appears to be low (<1%), it also
contains piperonyl butoxide (a synergist), which increases the toxicity. In
addition, the amount of pesticide that your dogs were exposed to from that
product really depends on how much of the shampoo was used. In other
words, you can't just go by that <1% figure.
In the future, I would avoid using flea and tick shampoos because they
contain pesticide. It's not necessary since you use Frontline (which is
also capable of causing adverse reactions).
Thank you again for writing. I hope your smaller dog will be back to
normal soon.
James
***************************************************************************************
Safe and savvy tips for protecting pets from fleas and ticks
Excerpts:
That's when I called up Heather Sanders, a Bay Area canine holistic health specialist and founder of Wags 'n Wellness to get her advice on some non-toxic alternatives to help protect pets from fleas and ticks.
TOTC: Q. Is there any reason not to use over the counter or prescription medications?
HS: A. I simply don't believe in putting chemical pesticides on my pets or myself. All of the conventional flea and tick treatments on the market have proven in testing to have serious side effects that range from local skin reactions to neurological deficits and organ failure. Be clear, these are not drugs that have been tested by the FDA. Instead, they are pesticides regulated by the EPA. There is a huge disparity between these agencies with respect to the amount and rigor of testing done before approval is granted to market the product. There is no way of knowing whether your dog will have a reaction after one treatment of a particular agent or if compound damage is taking place internally through continued use. Personally, it's not a risk that I am willing to take given that other safer methods of pest control.
TOTC: Q. What are some alternatives and how effective are they?
HS: A. For flea management, I advocate a three-pronged approach: 1. Feed a healthy, natural diet and keep your dog's immune system strong. I supplement with liquid vitamin B complex during flea system for added immune support. Parasites feed on the weaker animals and fleas are no exception. 2. Keep your house and your pet clean. 3. If you have a yard, treat it with beneficial nematodes. This natural form of pest management will control fleas that might be brought in by roaming or feral kitties, raccoons or rodents.
TOTC: Q. Do you have any specific grooming and housekeeping advice for keeping fleas at bay?
HS: A. Vacuum and sweep regularly. The cleaner your house is, the fewer bugs of any kind will take up residence there. Brush your dog at least twice a week. Brushing stimulates the skin and hair follicles, removes loose hair and prevents excessive shedding. It's good for the health of the skin and coat and also enables you to check for evidence of fleas or ticks. Fleas leave behind eggs and "flea dirt," which is their feces and is composed predominantly of dried blood. Flea eggs look like little grains of sand and "flea dirt" looks like dirt, but if you moisten it, you'll see that it has a reddish hue to it.
TOTC: Q. What do I do if I find fleas in my house or on my pets?
HS: A. The presence of flea dirt or eggs on your dog, his bedding or your furniture is indicative of an infestation. Similarly, if you or your dog has flea bites, you have a flea population in residence. In this case, you will need to set aside a day for a major cleaning. Bathe your dog with a shampoo that contains neem oil to kill any fleas. Clean all surfaces in your home, wash all bedding, vacuum upholstery and steam clean any carpeting. Be sure to empty the vacuum cleaner bag as the reproductive cycle can still perpetuate in this environment. Once everything is clean, sprinkle diatomaceous earth on carpets and bedding using a sifter. Leave it on for 24 hours and then vacuum again. It can be used directly on your pets as well. This fine, fossil powder kills fleas naturally by absorbing lipids from the waxy outer layer of insects' exoskeletons, causing them to dehydrate.
TOTC: Q. What do you recommend for tick prevention?
HS: A. When it comes to ticks, avoidance and vigilance go a long way. The good news is you can usually remove the tick before it has attached itself to your dog. Ticks prefer long grasses and wooded areas and are more numerous after rain or damp weather. If you will be in one of these areas, I recommend spraying your dog with Rara Avis Tick Spritz, an herbal spray that is safe and effective for repeated use on both yourself and your pet. Be observant during and after your hike and check your dog carefully. Ticks will seeks out warm areas of your dog's body, so carefully inspect the head, neck, armpits, groin and lower abdominal areas, and don't forget between the toes! I keep an eye out during a hike and then check immediately afterward and twice more in the next 12 hours. The thicker your dog's coat, the more time you will have to find them still crawling around.
TOTC: Q. Won't my dog be at risk if I'm not treating him with something to prevent tick-borne diseases?
HS: A. Tick-borne diseases are only transmitted if a dog is bitten by the tick and the tick remains embedded for a minimum of 24 hrs. Again, check your dog after exposure to tick habitats. If the tick has embedded its head, grab it as close to the skin as possible with your fingernail, taking care not to squeeze the body. Twist and pull to remove. If the head remains behind, do not dig it out as this will likely lead to infection. The body will push it out naturally in time. Never use petroleum jelly, a hot match, nail polish or other products to remove a tick! Flush the tick down the toilet — they are good swimmers and can crawl up drains! Crushing the tick releases the bacteria and pathogens it carries as well as the blood of any animal it has fed on. If you believe that the tick was embedded for more than 24 hrs, monitor your dog for a rash in the area of the bite and any abnormal behavior. Keep in mind that topical agents do not prevent ticks from biting. They simply ensure that the tick dies once it has bitten the animal after being exposed exposed to the pesticide in its skin.
Outstanding article! Here's an article today from Martha Stewart with similar advice:
***************************************************************************************
(Below is email that I sent to Kimberly Nesci at the EPA on 6/10/11)
Dear Kimberly,
I have repeatedly asked the EPA to release the Response to Public Comments regarding its pet spot-on evaluation, and have yet to receive a satisfactory response. As an interested stakeholder, I find that to be totally unacceptable.
Please release the Response to Public Comments without further delay.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
Dogs' ailments spark lawsuit over flea treatment
The Emmet County owners of a Yorkshire terrier that died and a poodle that suffered seizures have sparked a nationwide class-action lawsuit over the safety of a spray-on flea and tick medication for dogs.
Documents filed in U.S. District Court in Sioux City allege that Sergeant's Silver Flea and Tick Squeeze-On for Dogs was not properly tested before it was sold to consumers in Iowa and around the nation.
The lawsuit, brought by two women whose dogs had to be rushed for veterinary treatment following a May 2009 play date, seeks a refund and/or replacement goods for anyone who ever bought the allegedly hazardous medication, as well as reimbursement for vet bills, hospitalization costs and burials.
Becky Dodge said Sergeant's Pet Care Products Inc. rebuffed her pursuit of compensation after her 9-month-old puppy, Daisy, died in 2009.
"When a company has a bad product, it would be really nice if they would fess up to it and take care of it right away," Dodge said in an interview with The Des Moines Register. "It's not like my dog was a mutt. It was a Yorkie. They cost $500."
A Sergeant's spokeswoman declined to comment on pending litigation.
Court papers filed by Roxanne Conlin, the attorney for Dodge and her mother, Gladys Bruett, say the lawsuit eventually could require compensation of more than $5 million. Documents cite unspecified reports of complaints to the U.S. Environmental Protection Agency about Sergeant's Silver Squeeze-on from both dog owners and veterinarians.
The Iowa lawsuit says Bruett followed labeling instructions on May 3, 2009, when she applied Sergeant's Silver Squeeze-on to her 3-year-old poodle, Willi. Dodge estimates that it was roughly a half-hour before Willi arrived at her home to play with Daisy, and the puppy began jumping on its elder.
"Within about 15 minutes time, my dog was shaking, having a seizure, and its bowels started to move," Dodge said.
Court papers say both dogs suffered seizures and were taken to a veterinarian, where they were bathed repeatedly. Willi, the larger dog at 24.4 pounds, eventually was sent home. Documents say 2.2-pound Daisy "was unable to stand, had increased respiration, increased heart rate, neurological quivers and vomiting."
Dodge's dog "continued to worsen" and died within a few hours, according to the lawsuit.
Court papers argue that Sergeant's improperly benefited by inducing people to buy a product that consumers incorrectly believed to be safe.
In addition to other things, the plaintiffs also seek money for ongoing monitoring of their pets' health "to ascertain the extent of their damages."
"The thrust of the argument is, 'This is a defective product that has insufficient warning for safe use and that they have failed utterly,' " Conlin said.
The EPA's website shows federal regulators modified their stance toward flea and tick pesticides in March 2010 to require more clarity in labeling and more precise dosage instructions based on pet weight.
The EPA now recommends that consumers keep pets separated after applying the product until it is dry.
Sergeant's Silver Squeeze-On for Dogs, and Sergeant's Gold Squeeze-On for
Dogs, are the only pet treatments on the market that contain cyphenothrin -- a
Type II pyrethroid pesticide.
Here is an EPA document (written in December 2009) regarding cyphenothrin:
Excerpt from page 14:
"There have been several reported pet incidents involving the use of
cyphenothrin pet treatments on dogs. From January 2006 to November 2009,
there were 149 reported mortalities, 367 major reported incidents, 13,455
moderate reported incidents and 32,713 minor reported incidents. From all
reported pesticide related pet incidents, cyphenothrin products account for
10% of the total reported pet mortalities, 13% of all major incidents, 54%
of all moderate incidents, and 65% of all minor incidents. Some of these
incidents resulted from cyphenothrin products co-formulated with
pyriproxifen, and it is unclear whether one active ingredient or the other,
or an emergent effect from the formulation is responsible for these
incidents."
According to the EPA, Sergeant's Silver Squeeze-On for Dogs, and
Sergeant's Gold Squeeze-On for Dogs, pose risks of concern to toddlers.
Curiously, Sergeant's Silver Squeeze-On for Dogs, and Sergeant's Gold
Squeeze-On for Dogs, have been removed from Sergeant's website.
***************************************************************************************
(Below is email that I sent to Claire Gesalman at the EPA on 6/10/11)
Dear Ms. Gesalman,
Below is email that I sent to Kimberly Nesci on February 15, 2011. I have not yet received a response.
Could you please let me know why the human health risk assessment for Elanco's Assurity for Cats/Kittens (EPA Reg. No. 72642-9) used a minimum cat weight of 4 lbs., when in fact the label directions allow it to be used on cats as young as eight weeks old, and which typically weigh only 2 lbs.? Does the EPA plan to revise its human health risk assessment for EPA Reg. No. 72642-9, based on a minimum cat weight of 2 lbs.? How does the EPA plan to mitigate the risk to toddlers from using EPA Reg. No. 72642-9 on cats as small as 2 lbs.?
Thank you in advance for your timely response.
Sincerely,
James TerBush
Website Administrator
----- Original Message -----
From: "James TerBush" <james@elversonpuzzle.com>
To: <Nesci.Kimberly@epamail.epa.gov>
Cc: <Rossi.Lois@epamail.epa.gov>; "Rotkin-Ellman, Miriam" <mrotkinellman@nrdc.org>
Sent: Tuesday, February 15, 2011 2:14 PM
Subject: Spinetoram. Human Health Risk Assessment for Cat/Kitten Spot-On Use
Hi Kimberly,
Here is an EPA memorandum titled, "Spinetoram. Human Health Risk Assessment for Cat/Kitten Spot-On Use," which is dated October 12, 2010:
On page 24, it states that the intermediate-term aggregate risk calculation is at the LOC (level of concern) of 100, and recommends several possible actions to mitigate the risk, including restricting the minimum weight of cats that may be treated to 6 lbs., or decreasing the amount applied to younger cats.
However, the proposed cat/kitten spot-on product appears to have been registered (EPA Reg. No. 72642-9) on November 3, 2010, without ANY weight restriction or reduction in the dosage meant for cats under 6 lbs. As you can see on Elanco's website, the product is recommended for cats and kittens eight weeks of age and older:
EPA's risk assessment incorrectly assumed that cats as small as 4 lbs. may be treated with the proposed spot-on product.
According to this growth chart, the average weight of an eight week old kitten is approximately 2 lbs.:
If the above risk assessment had been based on the approximate weight of eight week old kittens, the intermediate-term aggregate risk calculation would have been significantly under the LOC of 100.
Could you please let me know how it was possible for that spot-on product to be registered when it posed a risk of concern to children? Also, does the EPA have any plan to mitigate that risk?
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
Do you have any information on adverse reactions from Sentry Natural Defense Flea and Tick Squeeze-On for dogs? I used it on all 6 of my dogs nearly a month ago for the first time. They were all fine except one of my pit bulls who has a history of allergies/skin problems. I thought a natural product would be gentle for him. He developed a large, bald calloused area between his shoulder blades and I'm wondering if it came from the product. It has since gotten scabby and looks worse. He has been seen by a vet and I'm sticking with the "wait-and-see" approach because I am hoping that the scabbing is a sign of healing, but I'm not entirely convinced. I'm worried about him. Have you heard about anything like this related to this product? Thanks for your time!
Clara 6/17/11
Hi Clara,
Thank you for contacting me. I haven't received many complaints about Sentry Natural Defense (which is also sold as Sergeant's Nature's Guardian). It contains essential oils, which are highly toxic to cats. I did a quick Google search, and most of the complaints
about it were due to the strong smell, or not being effective, or discoloring (yellowing)
white fur. However, some people have complained that their dogs experienced severe
skin irritation, scabbing, and hair loss at the site of application.
Here is some information (including product reviews) about essential oils and Sentry
Natural Defense:
http://www.onlynaturalpet.com/products/Sentry-Natural-Defense-Flea---Tick-Squeeze-On-for-Dogs/207000.aspx (see product reviews)
Excerpt:
PLEASE NOTE
We have had some reports of reactions such as skin irritation and hair loss at the site of application (see reviews below). In addition, the oils in the Sentry Natural Defense Squeeze-On may temporarily discolor white hair or fur. We recommend testing the product initially by applying a few drops in nape of the neck, and wait 24 hours to evaluate any response before applying the full dose. If you do see an adverse reaction, wash your dog with a shampoo or dishwashing liquid that contains detergents, as this is the most effective way to remove the oils causing the reaction.
(see product reviews)
I hope this helps.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
Hello James....
This evening I gave my miniature schnauzer BioSpot flea and tick killer. I soon noticed
that he was laying around, heavy respirations, dilated pupils, loss his appetite and seems "spacey", if you will. I tried all of the usual activities that I know my pet enjoys...his toys, a
walk, a car ride...nothing seemed to be working to "snap him out of this state". That lead
me to your name. I googled "dogs adverse reactions to flea and tick medicine" and I nearly
fell out when I saw BioSpot..and KNEW that I had administered it to my dog! I did as the site stated and bathed him immediately with Dawn dish soap.....I do know that some of it absorbed into his system and I am keeping a close eye on him for the next several days! He is still breathing a bit rapidly, but he has gotten up a few times. I can't believe that this product is STILL on the market as there were months of testimonies stating it's dangers to our "extended family members". Furthermore, what about the risk that this could impose to small children or pet owners.....someone better pull the plug on this product "months ago"!
Thanks for your time,
A. Rodney 6/17/11
***************************************************************************************
Bayer, Farnam reach agreement on flea, tick ads
(Reuters) - Bayer AG (BAYGn.DE) on Friday said Farnam Cos Inc had agreed to discontinue claims that its Bio Spot flea and tick control products are as effective as or superior to those of other animal-health companies.
Bayer had challenged the accuracy of Farnam print and online advertisements for its products, including one that Bio Spot is "the best flea and tick control available."
Bayer had argued in a challenge before the National Advertising Division of the Council of Better Business Bureaus that Farnam's advertising claims were false and unsubstantiated. Farnam, in turn, filed a lawsuit in the U.S. District Court in Arizona, seeking a declaration that its advertising was not false, Bayer said.
Bayer said a settlement had been reached, which ends its Better Business Bureaus challenge and the federal lawsuit.
As part of the settlement, Bayer said Farnam would discontinue all the advertising claims challenged by Bayer, and refrain from similar claims in the future. (Reporting by Ransdell Pierson; Editing by Lisa Von Ahn)
***************************************************************************************
Merial reports U.S. patent office confirms 'patentability' of
veterinary flea and tick product
Duluth, Ga. -- Merial reports that the United States Patent and Trademark Office "reconfirmed the patentability" of formulation claims covering Merial's Frontline® Plus.
"The ultimate result is that we expect some of the products infringing the formulation claims to be removed from the market," says Dr. Judy Jarecki-Black, Esq. Merial's head of intellectual property.
The government statement confirms the patentability of Merial's inventions directed at fipronil and (S)-methoprene containing spot-on compositions, Jarecki-Black says in a prepared statement.
Merial reports that it is pursuing litigation to protect its patent on the popular flea and tick brand.
"We plan to continue to vigorously defend our patent rights and continue our strong support of the veterinary profession," she says.
***************************************************************************************
Supreme Court backs EPA ban on a crop pesticide that's deadly to avians.
In a victory for environmentalists in general and birders in particular, the U.S. Supreme Court has denied a petition by pesticide manufacturers to challenge the Environmental Protection Agency's ban of a product blamed for sickening farm workers and killing millions of birds of more than 100 species.
The decision also blunts a weapon pesticide manufacturers recently began using to attack the EPA's regulatory power: demanding lengthy administrative hearings to prevent the agency from canceling food tolerance permits necessary for using chemicals on crops destined for human consumption that also enter wildlife food chains.
The high court's ruling in National Corn Growers et al. v. EPA upholds a federal appellate court decision that the agency could effectively ban domestic use of carbofuran, which goes by the trade name Furadan and is frequently used on crops such as potatoes, corn and sunflowers. Officials at the American Bird Conservancy claim it has proven deadly when ingested by birds such as the bald eagle, the eastern bluebird and the American kestrel. "The EPA decision confirmed what we've been saying for years: carbofuran is a deadly poison that has absolutely no place in our food or the environment," says Jason Rylander, senior staff attorney for Defenders of Wildlife. "The court's action means that, in this case, the health and safety of the American people and our nation's wildlife have trumped the profits of powerful corporations."
Despite the legal victory, EPA efforts to clamp down on unsafe use of pesticides are under challenge on other fronts. Several companies have refused to follow new safety measures mandated by the EPA to require tamper- and weather-resistant bait stations and limits on chemical composition of poison baits. The measures are primarily designed to protect children, who agency officials say are at particular risk for exposure to rat and mouse poisons.
According to the American Bird Conservancy, Reckitt Benckiser, the maker of d-CON rat and mouse bait, is fighting federal restrictions on their product, which is blamed for the deaths of raptors and owls that feed on rodents that have ingested it. A federal district court ruled in the company's favor, forcing EPA to conduct a hearing rather than exercising its enforcement powers to require removal of current stocks from store shelves.
Currently federal law makes it too easy to put pesticide products on the market before they are adequately tested for potential hazards to people and the environment.
As George Fenwick, the president of the American Bird Conservancy observes, "It has now been more than 35 years since DDT was banned, and we have been lulled into believing that our environment is adequately protected by an agency whose hands are tied by outdated, industry-centric regulations."
He argues the U.S. should follow Europe's example of banning potentially harmful pesticides from the outset and pressing industry to develop safer products.
The Supreme Court decision is a welcome affirmation of the ability of the EPA to use sound science to protect both humans and wildlife from unsafe pesticides.
Congress should consider revamping regulatory legislation to make it tougher for bad products to get on the market in the first place.
***************************************************************************************
Free Pizza, Pet Food and Products in Veterinary School Settings
Law school grad and second-year vet student at Colorado State University Michelle Dally decided it was high time someone stepped up and dissected the role of vet industry-sponsored freebies in an ivory tower setting. Like so many veterinary students before her, she questioned the ethics of free pizza, flea products and pet food in vet school.
Let me explain. Or rather, let me let the future Dr. Dally explain in her own words, which appeared in this last issue of the JAVMA (Journal of the American Veterinary Medical Association):
Every first-year veterinary student at Colorado State University is assigned a small desk in a dingy warren in the Anatomy building affectionately known as "the cubes." These desks are unremarkable in all ways but one: when students first arrive, they find their desks piled high with a variety of freebies — pens, notepads, backpacks, notebooks, highlighters, academic calendars, pet treats, pet food bowls, reference books, and more — all emblazoned with pet food, pharmaceutical, and other corporate brand names from across the veterinary industry. And that is only the beginning.
As the year unfolds, students discover that they are entitled to free and sharply discounted dog, cat, and horse food; free heartworm preventative; a free laboratory coat; and a free clipboard for use in their gross anatomy laboratory. Soon, first-year veterinary students are receiving e-mails through the official veterinary college e-mail distribution list encouraging them to apply to be corporate student representatives for a variety of companies — positions that typically involve little more than distributing additional freebies to their classmates and organizing one or two free lunchtime lectures. In return for their efforts, these student representatives are generally paid between $750 and $2,000 per semester. Some companies employ as many as two student representatives in each of the 4 veterinary college classes, whereas others employ only a single representative for each class or a single representative for the entire college. Regardless, the upshot is that there are typically one or two corporate-sponsored free lunches each week for veterinary students, and the corporate presence in the veterinary college is palpable.
Although it is not clear when some of these corporate-sponsored giveaways first began, the freebies and pet food discounts have been provided to students for at least the past five years. Given that most veterinary students are financially strapped and face a challenging academic schedule, the gifts, free food, and stress-free employment are typically greeted with enthusiasm and given little scrutiny.
Surprised? You shouldn’t be. It happens at all levels of veterinary medicine, given our corporate conglomerate culture, and it’s getting more pronounced now that (a) animal medicine is bigger business than ever before, and (b) schools and their students are so increasingly cash-stressed and indebted that getting a fifty percent discount on dog food can mean a significant boost in the quality of human food they can now afford.
But is it right? Ask most students and they’ll tell you it might not be right … but it’s definitely not wrong. After all, they say, the companies have the money and, let’s get real, they’re not so easily bought.
"As if I'm going to be influenced by a pen," is a common refrain when concerns about the provision of freebies to veterinary students are raised. But social science research has suggested that gifts, no matter how insubstantial, do indeed bestow the giver some influence over the recipient.
...
The idea that medical professionals could actually be influenced by insubstantial gifts may seem counter intuitive, but studies and surveys have shown that the impulses generated by gift-giving are neither rational nor totally conscious. As suggested by *Brennan et al., "Individuals receiving gifts are often unable to remain objective; they reweigh information and choices in light of the gift. So too, those people who give or accept gifts with no explicit 'strings attached' still carry an expectation of some kind of reciprocity."
So whether we’re talking pens or pet food, we are susceptible to the influence of the giver … whether we think we are or not. More so, it should be argued, when the giftee is at an especially receptive place in his/her training. Because if you haven’t developed a well thought out rationale for recommending pet food, drugs or anything else, getting free pizza when you’re really hungry has a way of carving the gifting company’s initials into your psyche.
It’s a no brainer, then. The research (clearly cited in Ms. Dally’s piece) indicates that students are susceptible; which is why no medical institution deigns to accept gifts on behalf of its students. Because who wants to unleash a batch of effectively brainwashed brand loyalists onto an unsuspecting marketplace?
Well, it’s probably not as bad as all that, seeing as competing brands are vying for our attention, and the more companies sell the more some individuals consciously resist. But still…
So what’s to be done? For starters, all veterinary schools could go the way of the University of California at Davis’s vet school. No corporate freebies are allowed — at all. A strict ban on gifts is in effect. An elegant solution to an ugly problem, I’m sure you’ll agree.
Nonetheless, I suspect veterinary schools will have to be dragged kicking and screaming into a vendor-free campus paradigm. After all, it’s not just the students who’ll have to give up the perks.
Dr. Patty Khuly
***************************************************************************************
(Below is email that I sent to Claire Gesalman at the EPA on 6/21/11)
Dear Ms. Gesalman,
Below is email that I sent to Kimberly Nesci on May 18, 2011. I have not yet received a response.
Recently, the EPA has registered several new fipronil-based spot-on products for pets from Sergeant's, LoradoChem, and Novartis. Instead of requiring the submission of new toxicity, safety, and efficacy studies to support the registration of these products, the EPA allowed the registrants to cite data that had been submitted previously for Frontline.
Despite the fact that the EPA's recent evaluation of pet spot-on products identified uncertainties about the "inert" ingredients in these products and how they might contribute to toxicity, and that the EPA will be pursuing actions to address these concerns, including not allowing the interchangeable use of inert ingredients in these formulations, could you please explain why the EPA allowed the above mentioned registrants to cite toxicity, safety, and efficacy studies that had been submitted years ago for Frontline? Given the concerns that the EPA has about inert ingredients, what assurance does the public have that these newly registered fipronil-based spot-on products are safe and effective?
Thank you in advance for your timely response.
Sincerely,
James TerBush
Website Administrator
----- Original Message -----
From: "James TerBush" <james@elversonpuzzle.com>
To: <Nesci.Kimberly@epamail.epa.gov>
Cc: <Rossi.Lois@epamail.epa.gov>
Sent: Wednesday, May 18, 2011 11:53 AM
Subject: EPA Reg. No. 86230-4
Dear Kimberly,
I am writing in regards to several pet spot-on products (PetArmor) that were recently registered by the EPA -- EPA Reg. No. 86230-1, 86230-2, 86230-3, and 86230-4. Instead of requiring the submission of new toxicity and companion animal safety studies to support the registration of these products, the EPA allowed the registrant to cite data that had been submitted previously for Frontline.
As you know, the EPA's investigation of pet spot-on products found that the companion animal safety studies did not accurately predict toxicity seen in the incident reports. As part of its risk mitigation plan, the EPA stated that it will no longer allow the interchangeable use of inert ingredients in these formulations. Furthermore, the EPA stated that it is taking additional steps to bring data requirements, including pre-market clinical trials, in line with FDA's requirements for similar products.
Please let me know why these risk mitigation actions were not applicable for the registration of the above mentioned products.
Sincerely,
James TerBush
Website Administrator
(Below is email that I received from Claire Gesalman at the EPA on 8/8/11)
Dear Mr. TerBush:
Thank you for your email of June 23, 2011, following up on an email that
you had previously sent to Ms. Kimberly Nesci regarding fipronil-based
spot-on products for pets. I am pleased to have this opportunity to
address your concerns.
Pesticide registrants are permitted to cite existing data under the
Federal Insecticide, Fungicide, and Rodenticide Act. An
“Identical/Substantially Similar” pesticide registration application
refers to a request to register a new pesticide product that is
identical in its uses and formulation or substantially similar in its
uses and formulation to one or more products currently registered and
marketed in the United States or differs only in ways that would not
significantly increase the risk of unreasonable adverse effects on the
environment. The agency has interpreted the phrase "….or that differ
only in ways that would not significantly increase the risk of
unreasonable adverse effects on the environment….” with regard to a
substantially similar or identical product to mean that the proposed
product:
·
must contain the same active ingredient,
must contain the same active ingredient,·have the same percentage or fall within the range of composition
have the same percentage or fall within the range of composition of currently registered products,
·have the same chemical composition,
have the same chemical composition,·have similar inert ingredients, and
have similar inert ingredients, and·contain the same use patterns or fewer.
contain the same use patterns or fewer.If the agency determines that a proposed new product is substantially
similar to an existing product or data can reasonably be expected to
support the desired product registration or amendment, we typically will
consider those data in support of the desired registration if a
registrant asks us to do so in its registration application. Thus, it is
reasonable to consider appropriate cited data in support of me-too
registrations, including me-too registrations of spot-on products.
The current review of incident data has not resulted in evidence to
suggest concern for any specific inert ingredient. However, EPA is
disallowing the use of alternate spot-on product formulations associated
with a specific registration identifiable by a registration number in
order to be able to tell whether or not unique inert ingredients or
formulations are more problematic than others as more incident data are
submitted and reviewed. We have not identified the existence of
alternate formulations, by itself, to be a problem; instead, the
presence of alternate formulations associated with one registration
number does not allow us to fully identify whether any inert ingredients
are of particular concern.
Further, please keep in mind that these new spot-on registrations are
subject to conditions of registration including enhanced reporting
requirements. When the agency registered these products, it had no
reason to believe they would result in greater incidents than the
originally registered product being cited, but we are imposing the same
conditions to better be able to track incidents associated with these
products.
I hope this sufficiently addresses your concerns.
Sincerely,
Claire M. Gesalman, Chief
Communication Services Branch
Field and External Affairs Division
Office of Pesticide Programs
(Below is email that I sent to Claire Gesalman at the EPA on 8/9/11)
Dear Ms. Gesalman,
Thank you for taking the time to respond to my email concerning the me-too registrations of fipronil-based spot-on products for pets.
In January, the EPA registered several fipronil-based spot-on products from LoradoChem, which did not contain the same active ingredient as currently registered products (Frontline). The fipronil technical that was registered for use in LoradoChem's products was found to contain 2.6% more of the active ingredient than currently registered fipronil technical. EPA's Technical Review Branch acknowledged that the 2.6% increase in the active ingredient "could alter the numerical results of the toxicity studies slightly, but would not appreciably alter the Toxicity Category classifications."
Even if the formulation of LoradoChem's fipronil-based spot-on products are "substantially similar" to Frontline, it would have been prudent for the EPA to require LoradoChem to submit new companion animal safety and efficacy studies, especially given the fact that EPA's evaluation of spot-on products found that "the data we now require to determine the safety of these products for pets do not accurately predict the toxicity seen in the incidents that took place."
It's also quite disturbing to learn that the registrant (Fipronext Solutions, Inc.) for the fipronil technical used by LoradoChem has just requested that its registration be cancelled, only
seven months after it was registered by the EPA, which was required in order to register LoradoChem's fipronil-based spot-on products. How was it even possible for Fipronext Solutions, Inc. -- a company with no employees, no manufacturing facility, and no previous pesticide registrations -- to register fipronil technical?
I would also like to make you aware that LoradoChem's fipronil-based spot-on products are being marketed as, "Same flea and tick protection as Frontline. Just as effective. Just as safe. About half the cost."
Is it still a violation of federal law to make safety claims for pesticide products?
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
Judge Says Cipla, Velcera Infringed Merial Patent
Law360, New York (June 21, 2011) -- A Georgia federal judge on Tuesday found Cipla Ltd. and Velcera Inc. in violation of a court order barring Cipla from infringing Merial Ltd.’s patent covering Frontline Plus, the blockbuster flea and tick repellent for pets.
U.S. District Judge Clay D. Land found Cipla in contempt of a March 2008 default judgment that enjoined the company from infringing Merial’s patent, and held that Velcera had acted in concert with the Indian company in its violation.
The court ruled that the two companies knowingly launched PetArmor Plus...
Looks like there's a chink in the PetArmor! If Velcera loses this battle, they will have to
remove PetArmor from the market.
For more information on this ruling, go to:
For additional information on this case, go to:
***************************************************************************************
Velcera and FidoPharm Will Pursue Expedited Appeal of Georgia Court
Ruling Against PetArmor™ Plus
YARDLEY, Pa., June 21, 2011 /PRNewswire/ -- Earlier today, the United States District Court for the Middle District of Georgia granted motions filed by Merial Limited and Merial SAS for contempt against Velcera and FidoPharm and their contract manufacturer for PetArmor Plus, Cipla Limited. The court has stayed its order for 60 days to allow for an appeal to the United States Court of Appeals for the Federal Circuit.
Velcera and FidoPharm intend to seek an expedited appeal and will vigorously defend their ability to continue selling PetArmor Plus, the first generic fipronil product available on retail shelves nationwide, in the United States. Velcera and FidoPharm also intend to pursue the action they filed in federal district court in Delaware in February 2011 seeking a declaratory judgment that Merial's patent directed to a particular composition containing fipronil and s-methoprene is invalid and not infringed by PetArmor Plus. The validity of Merial's patent was not at issue in the Georgia court proceedings.
Despite this ruling, PetArmor Plus remains available as a low cost flea and tick product for dogs and cats. Sales and availability of FidoPharm's PetArmor product remain unaffected by the ruling.
***************************************************************************************
(Below is a Freedom of Information Act request that I sent to the EPA on 3/24/11)
Please send me the Registration Jacket for EPA Reg. No. 70585-12, Novartis ParaStar (fipronil) for dogs.
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
How to choose between generic and a brand name product
Excerpts:
Q: I saw a generic flea product at a department store that claimed to be the same thing as Frontline. Is it really just as good?
A: The short answer is I don’t know. The active ingredient in Frontline is fipronil. There are now generic pet parasite products with the same active ingredient. However, that does not mean it is will work as well or be as safe as Frontline. At this point, these products have not been out long enough for me to make a personal determination.
My general rule of thumb is to wait for a year after a new product has been released before I will make a recommendation for my clients. I want someone else’s pets to be the guinea pigs. Several times in my career this cautionary approach has kept me from recommending something that was later pulled from the market for safety reasons. If these generics prove to be just as safe and effective as Frontline over a year or more, then I will feel more comfortable with them.
The active ingredient is only one factor in the effectiveness of a topical flea and tick preventive. There are ant and roach baits at your local hardware store that use fipronil as their active ingredients. I would never suggest it would be alright to cut one open and put it onto your dog.
The product’s carrier makes a difference in how well the compound spreads over the body and how waterproof the protection will be. In addition, a significant percentage of adverse reactions that I have seen to top topical pesticides appear to be the result of the carrier more than the active ingredient.
The real question should be, “is trying a new generic product worth the savings?” The least expensive generic I have seen was $28 plus tax for three doses. That works out to $9.80 per dose. In my office, we sell eight doses of genuine Frontline for as little as $10.74 per dose. In my personal opinion, I don’t think ninety-four cents a month is a significant enough savings to make my dog or cat the guinea pig for a new generic pesticide.
Finally, Frontline is made in France and backed by your veterinarian and Merial, one of the world’s leading drug manufacturers. Check those generic product boxes to see where they are manufactured and who is backing them. The ones I have seen are all made in Asian countries with histories of product recalls due to safety issues. It is unclear to me what if any support will be available for adverse reactions or effectiveness complaints.
For now, I’ll stick with Frontline or one of the other veterinary products that I have come to trust.
***************************************************************************************
US court penalises Cipla for violation of order
Company faces possibility of seizure of its existing drug inventory
Drug major Cipla has violated a US court order, which may lead to seizure of the existing inventory of a flea and tick repellent for pets manufactured by it.
The issue relates to tick repellent ‘FrontLine Plus’, estimated to have had sales of $700-900 million last year. The drug belongs to the $2.6-billion Merial, a Sanofi company that makes animal-focused products.
FrontLine Plus is the leading veterinary pesticide in the US and its cheaper generic product market is also lucrative, said industry analysts who wished to remain anonymous. As per the order of the US district court for Middle District of Georgia delivered last week, Judge Clay D Land found Cipla in contempt of a March 2008 default judgment that prohibited the company from infringing Merial’s patent, and held that US-based drug firm Velcera had acted in concert with the Indian company in its violation. Velcera sold the generic version of FrontLine Plus as PetArmor Plus while Cipla was the contract manufacturer.
The court has ordered that Cipla and Velcera would be permanently prohibited from engaging in the sale of these drugs but given the potential immediate and serious impact of the order, its enforcement will happen only after 60 days.
This window has been given to provide them an opportunity for meaningful review, a copy of the order accessed by Financial Chronicle showed.
The court will also conduct a hearing to determine an award to Merial for damages relating to all sales committed in violation of the court’s order, including lost profits or a reasonable royalty for all sales. In 2010 itself, sales of FrontLine and related products slumped from $320 million in the first quarter to around $150 million in the fourth quarter. Details of the generic sales were not available.
Cipla and Velcera have been asked to provide in writing within 60 days of last week’s order, details relating to sale of any veterinary product containing fipronil and methoprene manufactured by Cipla after the March 2008 order. Fipronil and methoprene are bulk drugs that make a chemical formulation used for Merial’s FrontLine Plus.
Velcera said in a statement that the court has stayed its order to allow for an appeal to the US Court of Appeals for the Federal Circuit. Both Cipla and Merial did not respond to emailed queries seeking comment till the time of filing this story.
***************************************************************************************
(Below is a Freedom of Information Act request that I sent to the EPA on 6/28/11)
Please send me the Pet Fur Residue Transfer study that was submitted by Sergeant's Pet Care and/or Wellmark International regarding propoxur pet collars. The study, which was requested by the EPA, was supposed to have been submitted before the end of 2010, and was the first study undertaken under the Draft Guidance Document for Developing Protocols Designed to Collect Pet Fur Transferable Residues Using Mannequin Hands.
The above mentioned study is referred to in this document:
Thank you for your consideration.
Sincerely,
James TerBush
Website Administrator
***************************************************************************************
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.
Search
