Message Board
September 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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My dog Rommel, he is a schnauzer, 2 years old, 14.7 lbs and for the past few days we have noticed he's gotten really sick. He had what looked like hives all over his tummy, vomiting, trembling, trembling every time he took a breath in, loss of appetite, labored breathing, sinuses were swollen shut, blood in stool, depression, and his stomach swelled. We took him to our vet today and he said that his eyes were so dilated that they didn't even respond to his flashlight. His lungs were swollen as well and was very very close to death. We got extremely lucky because our vet said that this product BioSpot kills dogs and should not be administered to any animal less than 800 lbs and should only be used on horses. He also said he was in anaphylactic shock* (insectiside poisoning). Our vet administered two shots. This is terrible, this product should be pulled from the market. I just thought I would share this story with you.
Rachel 9/2/11
We called the ASPCA and you're right, they actually defended BioSpot. It was unbelievable some of the things she was saying. Very interesting but I just wanted to say Thank you for all your help, any additional information you have that will help I will surely appreciate. We are going to do everything we can to get something done about this.
Rachel 9/6/11
I am sorry to say that I no longer trust the ASPCA Animal Poison Control Center concerning adverse reactions associated with the use of flea and tick control products. Several people have reported to me that the ASPCA Animal Poison Control Center had advised them that Bio Spot does not cause serious adverse reactions in dogs.
The ASPCA actually receives money from the maker of Bio Spot (Farnam) to provide free consultation to people whose pets have been poisoned by their products. The ASPCA also provides Farnam with consulting on legal cases and product liability. That is a serious
conflict of interest!
Prior to joining the ASPCA, its Chief Operating Officer worked for Wellmark International (maker of Zodiac brand flea and tick products), which also happens to be owned by the same parent company (Central Garden & Pet) that owns the maker of Bio Spot (Farnam).
James TerBush
Website Administrator
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Hartz UltraGuard Plus Burns Dog's Skin
So much for saving money and living better...
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Hello James,
Just wanted to write to you after losing two of my precious cats. My son's
calico female who was 1.5 years old and my sweet registered male persian
Spidey, who was in my life for 12 years. One minute they are both beautiful,
sweet and vibrant pets. It really was odd, because they were happy and then,
deceased. I applied Spidey's first because Bootz my son's cat was playing on
our deck. Spidey being an old man prefered to lounge around. So after I
applied his in a few hours he had gone down stairs, but then never came up
for his evening feeding. I seached EVERY WHERE but when I found him he was
dead. At first I thought it was old age, but that was before I noticed Bootz
behavior after her application which was a few hours later. She was foaming
out the mouth and I tried to catch her but she ran off. She hid outside and
I called and called. Nothing. She never responded. She was acting strange,
then I knew something was up. Next morning after searching I found her dead
under my son's toy ride on. She used to ride it with him. It's so sad she
went there to die.
I'm so angry, but most of all i'm heart broken. I know my pets were healthy.
Both were fixed, had shots, one was indoor outdoor the other (Spidey)
strictly indoors. He was declawed and a bit of a couch potato. Why are these
products still out there? I never used them before this instance. It just
seems wrong that I tried to save a little money and for that my cats are
dead. My son who is 3 keeps asking about his cat, but I just tell him she's
probably playing outside. One day he'll stop asking, but it's the
knowing....I read online about the products. It was the only thing that
COULD have done this. My cats had NEVER used this before. I didn't know it
was unsafe before application or i'd never have used it.
I'm really disgusted with these people. Is there any petition out there to
get rid of this stuff?
Gina 9/10/11
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I was given a case number of 2010-US-34286
On Saturday Sept. 4 , 2010 I used Promeris flea drops on my miniature Schnauzer. I applied the drops around noon. She became ill about 24 hours later vomiting and up everything she ate. The next day when she could not even keep water down. I took her to the vet and she had amitraz tox. from the Promeris flea drops. Treatment was started for gastroenteritis- foreign body infectious. Antibiotics were given along with a pill to help with the vomiting. I continued the medicines for the week plus left her at daycare for the remainder of the week. After meds were completed went back for a recheck. Around the end of oct I noticed she (Jazzy ) started sneezing so after about a week I decided to take her back to the vet with the cold, sneezing and nasal discharge. She was given a shot of antibodies, and a antihistamine, which did not seem to take care of the cold. I then took her back to the vet and was given another round of antibiotics. Nothing seem to help, even with continued visits to the vet. Then on Sat Nov 27th she had a seizure. I then rushed her to the vet and I found out that her sugar was very low and the liver counts were elevated. She had a week long hospital stay without improving much. I then found a vet with a ct scan which I took Jazzy for a scan to make sure no tumors were present. None were seen. I was told that the stomach area looked strange. But no tumors or anything like that was present. My Jazzy died on Dec 6th 2010 she was 7 years old and I believe that the toxins she got from Promeris flea drops killed her. Not because she licked them because she did not. These flea drops are toxic and the toxins lead to her death. I am requesting that my vet bills be taken care of and that the drops have more of a warning on them. With a vet having to prescribe treatment with this only after she has examined the dog. If I could I would like to see them taken off the market all together . On the following pages you will find connections of toxic poisoning and death. My Jazzy went to the vet very few times before the Promeris flea drops came into the picture.
Karen 9/11/11
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Pesticides in food linked to ADHD in kids
Excerpts:
Levels of pesticides commonly encountered across the country in food as well as around the home are significantly increasing children's risk of developing attention deficit hyperactivity disorder (ADHD), and could be causing an increase in the number of children living with the condition, according to new research published in the journal Pediatrics.
"It's mainly exposure through food. Diet is the driver," says pediatrician and public health expert Phil Landrigan, MD, professor and chair of the department of community and preventive medicine at Mount Sinai School of Medicine in New York City. "For most people, diet is the predominant source. It's been shown that people who switch to an organic diet knock down the levels of pesticide by-products in their urine by 85 to 90 percent."
Beware of other exposures. Pesticides, by nature, are designed to kill, and the ones homeowners used around the house are dangerous, too, Dr. Landrigan explains. Instead of spraying your lawn or home, use organic gardening methods and practice nontoxic bug control. (emphasis added)
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Some EPA 'experts' are not really qualified
The above article was published on December 3, 1991. Incredibly, the same problems
noted in the article have existed at the EPA for the past 20 years!
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Thanks for having this available. Not sure how current it is, but I'd like to
add a little something.
Being in dog rescue for over 15 years, we've used a lot of different flea
and tick medications, have had some rare reactions as well. I have had a
few dogs react to Frontline especially. One dog was burned from the product
another would run whenever we tried to put Frontline on him and we realized
it caused a skin irritation and was only trying to get away from the irritation
we were causing. We shy away from the flea collars as that emits medication
very close to the dog's head continually. As well, pets are closer to the ground
than us humans and products we use on the flooring has an effect on them
as they can inhale these products from sleeping on the floor, etc.
I would suggest being careful with the chemicals we are putting on our animals
as they can cause reactions. Try to find products that are environmentally safe
and only use when you need it. Always check with your veterinarian and ask
questions. You are your pet's advocate, they cannot speak. If you are not
getting answers, check with another vet.
Michele 9/15/11
Georgia Canine Adoption Nework
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Central Launches New Flea/Tick Applicator
Central Animal Health, a unit of Central Garden & Pet Co., debuted its new Safety Shield applicator for both its Bio Spot Defense and Adams Flea and Tick Spot On topical flea and tick control products at the 2011 SuperZoo trade show held in Las Vegas.
The new applicator is part of Central’s response to the U.S. Environmental Protection Agency concerns about label clarity across the flea and tick control segment, and a large number of consumer-related adverse events with such products, according to Steve Leveau, marketing director for Central Animal Health, which was formed this summer to focus on pet health products.
This year, the company had switched formulations from a permethrin-based formula to a less toxic one using etofenprox (adulticide) and (s) methoprene (insect growth regulator), Leveau said.
The new applicator will allow pet owners to place a package of solution into the applicator, which will help part the pet’s fur, prevent spillage of the topical onto the user’s hands or other objects, and regulate the dose so that the topical is evenly spread, Leveau said.
The company also reconfigured its dosing, narrowing most weight ranges in the process of moving from a four-size line to a five-size line for dogs. The applicators are color-coded for dogs and cats, and feature notches that prevent the dog topical from being inserted into the cat applicator, and vice versa.
The new applicator will begin shipping in the first quarter of 2012, ahead of flea and tick season. A major marketing campaign will support the launch: Leveau’s budget for the campaign is larger than the past five years’ combined marketing budgets for flea and tick products.
The company has developed a variety of POP and educational displays, a couponing program, and QR codes that will allow pet owners to watch instructional videos. The key marketing points will be that the product starts to kill within 15 minutes, includes an insect growth regulator to prevent re-infestation, and features the new applicator.
The applicators will be included in almost all packages sold in 2012, Leveau said, as he attempts to get the applicators in as many hands as possible. For added convenience, the plastic packages are resealable.
In 2013, Central expects to offer packages with and without the applicators in a razor/razor blade model.
Consumers are looking for safety-for both their pets and their families-and efficacy, Leveau said, noting the product has been in development for the past 18 months.
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I'm glad I found your website. I recently adopted a dog from rescue and was given Biospot
to use for flea & tick control. I placed the product on my dog Lady in 3 places according to instructions. After a few days, she had terrible red, itchy weepy patches on her back and was loosing her hair. I took her to the vet who agreed with me that it must be an allergic reaction. He clipped and cleaned the areas,and prescribed steroids and antibiotics. Then I thought I would go online to see if there were other similar reactions. Boy, was I shocked! And happy that my situation was not as bad as others.
Please help stop these pet products from being sold.
Mary 9/18/11
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(The following message was posted on HartzVictims.org on 9/23/11)
Preying on the Poor
I want to forget that today ever happened… but it did, and before I do I want as many people as possible to hear about it. I work at an animal shelter in Philadelphia which also has a veterinary clinic in it. I am a kennel attendant at the shelter. I have only been working there
a month. Today one of our volunteers who is there to fulfill community service hours for the welfare program killed her kitten Gizmo. She loved Gizmo. She was trying to care for her
pet with the limited funds she has. She saw that Gizmo had fleas and thought she would go out and buy something to relieve her. The product she bought was Hartz spray. Hartz is a brand who’s name she recognized. It is a brand that claims to work and be safe. Why would she have any reason to think otherwise. That is the image that is promoted by their company. That is the brand that is sold in her local store. She saw that the kitten was acting funny after she treated it but couldn’t imagine why. By the time she got the kitten to the shelter it was already seizing. We scrubbed and washed little Gizmo as best we could but the poison, because that’s what it is POISON had already been on her too long. The vet determined
that there was nothing left to do but put her to sleep as she was suffering terribly. I have
never felt so helpless as i did holding that dripping wet, dying animal and looking at the l
ook of utter confusion and devastation on the face of her owner. People who live in low income neighborhoods have as much a right to have healthy pets as anyone. If no one ever tells you that something is poisonous and it is being peddled as medicine; how are you to know???? Please spread the word.
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After my cat rubbed up against my dog who just had Biospot put on she unknowingly came in contact with it... It wasn't long and she was in serious seizure activity! Thank god my sister is a nurse.. she saved her life! After all of this I notice burn spots on my dog in the exactly spots the biospot was applied!
This product is dangerous! None of the other flea and tick brands have ever burned my dog! Something should be done to remove this shit from the market!
Nikki 9/26/11
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I wanted to know if anyone else had a dog who died of Trifexis and what
can be done.
My 4 year old Boxer passed away on 8/2/11 from what the vet said looked
like poisoning which is virtually impossible since he never left my site. When
I was not home he was confined to an indoor kennel and he was never left
unsupervised inside or outside the house.
I protected this dog with my life because he was my child not a dog and I
never wanted anything to happed to him. I racked my brain trying to figure
out what in the world happened and the only thing that had changed is that
the vet changed his heartworm preventative to Trifexis 3 months prior. And
he died 3 days after I administered the 3rd dose.
I questioned the vet about this and of course they denied that could be
possible. Which after searching the internet YES that is very well possible
and the only explanation.
I was wondering if you could help me with this and is there a lawsuit
against Trifexis that I could also get with.
I want to warn people of this Trifexis that Killed my baby so that no one
else has to go through the heartache like I will for the rest of my life.
Please any help that you could offer would be greatly appreciated.
Thank You
Gunner's Mom
In Loving Memory of "Gunner"
2/14/07-8/2/11
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Scientist fired by Merial alleges Heartgard Plus coverup
June 7, 2011
By: Jennifer Fiala
For The VIN News Service
A former regulatory employee at Merial says she was fired after refusing to destroy a document questioning the effectiveness of Heartgard Plus, a top-selling heartworm preventative.
Kari Blaho-Owens, Ph.D., makes that claim and others in a lawsuit against Merial LLC, the animal drug division of Sanofi Aventis. The case was filed last month in U.S. District Court for the Northern District of Georgia, Atlanta Division.
Blaho-Owens, hired in 2006 as Merial's head of global pharmacovigilance, contends that Merial executives deliberately suppressed studies showing that Heartgard Plus is losing efficacy and fired her when she refused to destroy documents questioning the drug’s effectiveness.
Heartgard Plus is primarily marketed to prevent heartworm infestation in dogs. It contains ivermectin and pyrantel, two broad-spectrum antiparasitic agents. The meat-flavored chewable tablets are given monthly to dogs to control hookworms and roundworms, in addition to preventing heartworms.
In a statement to the VIN News Service, Merial officials promised to "vigorously defend the case."
"At Merial, we stand by the effectiveness of our products," the statement says. "Merial is confident that the Heartgard (ivermectin) brands are highly effective when used in accordance with their FDA-approved labels. Heartgard Plus is the number-one choice of veterinarians for the prevention of heartworm disease — a serious threat to dogs."
By contrast, the 29-page lawsuit alleges active disregard by Merial executives to the possibility that Heartgard might not be 100-percent effective — even after the U.S. Food and Drug Administration's Center for Veterinary Medicine (FDA CVM) repeatedly asked Merial to change the product’s label and notify veterinarians that in some cases, Heartgard Plus had not worked as advertised.
The drug's eroding efficacy wasn't news to the company, the lawsuit contends, insinuating that Merial executives had known of mounting troubles with the effectiveness of Heartgard Plus since at least 2000. The FDA approved the drug in October 1996, noting, as part of the agency's review process, "100-percent efficacy demonstrated in the dose confirmation studies" and "100-percent efficacy in the clinical field trials."
The lawsuit states that Dr. Felipe Dolz, then-director of Merial's regulatory affairs, believed that acknowledging that Heartgard Plus is less than 100-percent effective on the label would put Merial at a marketing disadvantage unless the CVM posed an industry-wide policy that would equally affect competitors.
The FDA spent four years pressuring Merial to lose the 100-percent effectiveness claim in reference to Heartgard Plus until the company complied in 2006. But another CVM-issued warning letter came in 2007, this time alleging false advertising. The CVM challenged Merial's promotional verbiage that claimed using Heartgard in pets would control the spread of zoonotic diseases to humans, though there was no scientific evidence to support that claim.
Behind closed doors, Merial officials blamed the appearance of efficacy troubles with Heartgard Plus on a surge in product sales and lack of compliance on the part of owners — not a product failure, the lawsuit says. But Blaho-Owens found the statistical analysis and methodology of an internal investigation that allowed Merial to come to those conclusions to be steeped in flawed science. Among her criticisms, Blaho-Owens noted that Merial's study was not blinded and evaluated just 7 percent of all Heartgard Plus-related adverse event cases. Her own cursory investigation demonstrated that Heartgard Plus had an approximate 20-percent failure rate, the lawsuit says.
Upon pushing higher ups to conduct more sound analysis of the drug's efficacy, the lawsuit says Blaho-Owens was shut down. Additionally, the lawsuit alleges that Merial improperly filed adverse event reports with the CVM, effectively burying the ones that showed efficacy troubles with Heartgard.
A query to the CVM seeking insight into the legitimacy of the lawsuit’s claims was not immediately returned. The CVM lists more than 26,000 adverse event reports involving oral ivermectin and pyrantel — active ingredients in Heartgard Plus — but regulators do not tie brand names to the events, and several other manufacturers make pet parasiticides with formulas containing those chemicals. Furthermore, though ineffectiveness is named as an impetus for some of the adverse event reports, a variety of other reactions are listed.
In September 2009, Blaho-Owens was notified of a class-action suit against Merial regarding Heartgard. Dolz instructed her to destroy a document in her possession that likely was relevant to the pending lawsuit and to stop generating any new analysis on the efficacy of Heartgard Plus, the lawsuit says.
Rather than destroying the document (the contents of which are not detailed in the lawsuit), Blaho-Owens reported the request to Merial's legal counsel, Adam Bassing. It was then that she learned that the class-action lawsuit related to Merial's refusal to change its labeling as initially ordered by the FDA in 2002.
She also learned of another Merial whistleblower who had accused the company of falsifying sales data — figures that Blaho-Owens relied on to perform her own safety and efficacy analysis for the FDA and international regulatory authorities. The lawsuit states that she complained to Merial officials that the company's doses sold/distributed data changed randomly, were inconsistent and no controls existed to assure the accuracy of the figures.
"Dr. Blaho-Owens was told by Dr. Dolz to ignore the problems and just use the data that her department retrieved from the finance databases to prepare her reports, and she did so," the lawsuit says.
On Nov. 11, 2009, the scientist was placed on a performance improvement plan, which cited a "lack of understanding the differences in levels of priorities" between Blaho-Owens and Merial's management. Dolz, the lawsuit says, then started implementing a workload designed to force Blaho-Owens out of the company.
On Jan. 29, 2010, Blaho-Owens filed a claim for retaliation against the company with the U.S. Department of Labor, Occupational Safety and Health Administration. Two months later, the plaintiffs for the class action filed for a temporary restraining order against Merial and its employees to cease and desist in the further destruction of documents.
It is unclear in the lawsuit what contact, if any, Blaho-Owens had with the class action plaintiffs. Blaho-Owens and her attorney, Christopher Vaughn, could not be reached immediately. The temporary restraining order filed by the class action plaintiffs referenced Blaho-Owens' complaint with the labor department.
Blaho-Owens says in her legal complaint that on April 6, 2010, Dolz told her that "Merial was done with her." She was terminated three months later. She is suing for an unspecified amount of relief that includes back pay, front pay, lost benefits and attorney's fees as well as damages for emotional distress and loss of professional reputation.
She also wants Merial officials to write her a letter of apology.
Editor's note: This article was altered from its original, which incorrectly identified Kari Blaho-Owens as a veterinarian.
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Growl! Merial Fired Exec For Protecting Dogs
File this under biting back. A former regulatory employee at the Merial animal health operation has filed a sensational lawsuit charging the Sanofi unit with deliberately covering up adverse event reports for its Heartgard Plus heartworm product for dogs and repeatedly rebuffing FDA admonitions to alter promotional material that overstated effectiveness.
The trouble began in 2006, when Kari Blaho-Owens joined Merial, which at the time was a joint venture between Merck and Sanofi, as head of global pharmacovigilance and began reviewing internal reports about Heartgard Plus. What she allegedly discovered was a scheme to resist efforts to update product information for vets and dog owners over concerns that sales would plummet. Most adverse events Merial received some years were for Heartgard Plus and a lack of effectiveness in dogs, the suit states.
Along the way, she allegedly came across a scientifically unsound internal investigation, a failure to properly record adverse events and falsified sales data needed for compiling pharmacovigilance reports. She was also told to destroy documentation by the regulatory affairs director after a class action lawsuit was filed in August 2009 over repeated Merial refusals to change Heartgard Plus labeling at the request of the FDA, according to her lawsuit. Her supervisor “cautioned Dr. Blaho-Owens that conducting a study may reveal data and conclusions that Merial might not necessarily want to uncover.”
Merial officials had a track record of claiming their product was 100 percent effective and ignoring warnings from the FDA’s Center for Veterinary Medicine, which issued letters in 2006 and 2007 (read here and here). This pattern apparently occurred for years, and her lawsuit notes Merial failed to issue a ‘Dear Doctor’ letter even after its own 2005 internal investigation found problems.
“Merial fraudulently promoted and sold Heartguard as 100 percent effective despite its knowledge since at least 2002, that Heartguard products were substantially less than 100 percent effective in violation of FDA regulations. Merial knew well that the LOE (lack of efficacy) of Heartguard was increasing on an annual basis. Merial intentionally concealed this information from the consuming public and the veterinarians reselling Heartguard,” the lawsuit states. Merial “chose to conceal this fact from the general public and to allow the fraud to continue to prevent significant loss of market share for its ‘flagship’ product, which would reduce Merial’s profit margin tremendously.”
Things went downhill for her, though, when she refused to destroy documents or end her efforts to further analyze lack of efficacy reports. Blaho-Owens subsequently reported those marching orders to Merial legal counsel and, for her trouble, was placed on a performance improvement plan. She later filed a complaint with the US Department of Labor and was fired last September (you can read her lawsuit here). We left a message for Merial for comment and will update you accordingly.
UPDATE: A Merial spokesman sends us this: “Merial is aware of the lawsuit filed against the company by former employee, Kari Blaho-Owens. As a matter of company policy, we do not comment on the details of pending litigation or on employee-related issues. An earlier complaint by this employee has already been dismissed by the United States Department of Labor. At Merial, we stand by the effectiveness of our products. Merial is confident that the Heartgard brands are highly effective when used in accordance with their FDA-approved labels.”
One of her contentions: Merial was combining serious and non-serious adverse event reports to the FDA. “By combining the serious cases with the non-serious, it would not be apparent from reading the summary in the (Drug Evaluation Reports) that there was an increase in the frequency of lack of efficacy cases over time for Heartguard Plus,” according to the lawsuit. She charges Merial only gave the FDA a “high level summary” of the number of cases, the number of doses distributed and whether the numbers were statistically different from the preceding year. But there was no assessment.
Another allegation: After reviewing the 2005 internal investigation, she contends the statistical analysis used did not conform to recognized scientific standards, because it was not blinded, and the overall effort was conducted using “cherry-picked” data. Moreover, the study included and evaluated only 7 percent of the total number of “Heartgard Plus” adverse event cases.
Moreover, the methods to analyze data relied on the number of doses of “Heartguard Plus” that had been sold to determine a rate of lack of efficacy. But the rate was based on financial data that, she charges, had “serious and chronic problems in data integrity.” Blaho-Owens, by the way, was not the only whistleblower. An accounting employee also filed a lawsuit alleging Merial falsified sales data.
Another nugget: Blaho-Owens found ‘lack of efficacy’ cases that had “the highest degree of customer compliance and the lowest degree of other confounding factors,” and had been investigated by the Merial Technical Service group. What happened? “…compliance by the dog owner was found to be so substantial that Merial had agreed to pay for the heartworm treatment for the particular dog,” according to her lawsuit.
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(Below is email that I sent to Wade Britton at the EPA on 9/29/11)
Wade,
Here's an interesting article that was published in June regarding Merial's alleged effort to mislead the FDA by submitting pharmacovigilance reports that contained improperly recorded adverse event records and falsified sales data:
Excerpts:
"A former regulatory employee at Merial says she was fired after refusing to destroy a document questioning the effectiveness of Heartgard Plus, a top-selling heartworm preventative. "
"Blaho-Owens, hired in 2006 as Merial's head of global pharmacovigilance, contends that Merial executives deliberately suppressed studies showing that Heartgard Plus is losing efficacy and fired her when she refused to destroy documents questioning the drug's
effectiveness. "
"Behind closed doors, Merial officials blamed the appearance of efficacy troubles with Heartgard Plus on a surge in product sales and lack of compliance on the part of owners - not a product failure, the lawsuit says. But Blaho-Owens found the statistical analysis and methodology of an internal investigation that allowed Merial to come to those conclusions to be steeped in flawed science. Among her criticisms, Blaho-Owens noted that Merial's study was not blinded and evaluated just 7 percent of all Heartgard Plus-related adverse event cases. Her own cursory investigation demonstrated that Heartgard Plus had an approximate 20-percent failure rate, the lawsuit says."
"Upon pushing higher ups to conduct more sound analysis of the drug's efficacy, the lawsuit says Blaho-Owens was shut down. Additionally, the lawsuit alleges that Merial improperly filed adverse event reports with the CVM, effectively burying the ones that showed efficacy troubles with Heartgard. "
Here's another article regarding it:
Excerpts:
"File this under biting back. A former regulatory employee at the Merial animal health operation has filed a sensational lawsuit charging the Sanofi unit with deliberately covering
up adverse event reports for its Heartgard Plus heartworm product for dogs and repeatedly rebuffing FDA admonitions to alter promotional material that overstated effectiveness."
"The trouble began in 2006, when Kari Blaho-Owens joined Merial, which at the time was a joint venture between Merck and Sanofi, as head of global pharmacovigilance and began reviewing internal reports about Heartgard Plus. What she allegedly discovered was a
scheme to resist efforts to update product information for vets and dog owners over concerns that sales would plummet. Most adverse events Merial received some years were for Heartgard Plus and a lack of effectiveness in dogs, the suit states."
"Along the way, she allegedly came across a scientifically unsound internal investigation, a failure to properly record adverse events and falsified sales data needed for compiling pharmacovigilance reports. She was also told to destroy documentation by the regulatory affairs director after a class action lawsuit was filed in August 2009 over repeated Merial refusals to change Heartgard Plus labeling at the request of the FDA, according to her lawsuit. Her supervisor "cautioned Dr. Blaho-Owens that conducting a study may reveal data and conclusions that Merial might not necessarily want to uncover." "
Here is a statement that Merial issued in 2009 regarding the EPA's evaluation of pet spot-on products:
Excerpts:
"Although the EPA has stated that it has noted a 'sharp increase' in the number of reported adverse events associated with the use of spot-on flea and tick control products, our records do not indicate that this is the case for FRONTLINE®. The number of adverse events reported per volume of sales has remained consistently low since the introduction of FRONTLINE in 1996. Over one billion doses of FRONTLINE have been sold, so there is extensive experience with the product in marketed use."
"Merial's Pharmacovigilance Department analyzes and records all suspected adverse events reported to the company concerning FRONTLINE products and reports them to the EPA, consistent with federal law. Most reported events are not serious; these include mild skin irritation at the site of application, transient lethargy and vomiting. But, Merial's policy is to record and report even the most minor adverse event."
The allegations made by Dr. Blaho-Owens -- Merial's former head of global pharmacovigilance -- should be of concern to the EPA. Health Canada (which collaborated with the EPA's evaluation of pet spot-on products) acknowledged that key limitations of its analysis included "questionable quality of the data reported in incidents" and the "under-reporting of incidents by the registrants." Clearly, registrants should not be entrusted with the responsibility of collecting, analyzing, and submitting incident reports to the EPA.
Sincerely,
James TerBush
Website Administrator
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For Perry, the E.P.A. Has Long Been a Favorite Target
Excerpts:
Gov. Rick Perry of Texas has built a political career running against Washington, and no agency more symbolizes what he considers the meddlesome and economy-choking evils of the federal government than the Environmental Protection Agency.
Mr. Perry’s conservative views on business costs, states’ rights, job creation, energy policy and global competitiveness — the core of his governing philosophy — are illuminated most vividly in his clashes with the E.P.A. over issues like pesticide regulation and global warming.
From his earliest days as head of the Texas Department of Agriculture to his current campaign for the Republican presidential nomination, he has struck a consistent anti-regulatory chord.
Catherine Frazier, a Perry campaign spokeswoman, said in an e-mailed statement, “If elected president, the governor’s energy priorities will be centered around scaling back the E.P.A.’s intrusive, misguided and job-killing policies, which will empower states to foster their own energy resources without crippling mandates and open the doors for our nation to pursue and strengthen an all-of-the-above energy approach.”
Mr. Perry used more colorful language this month in addressing a Tea Party group in Florida.
“Somebody has to tell the E.P.A. that we don’t need you monkeying around and fiddling around and getting in our business with every kind of regulation you can dream up,” he said. “You’re doing nothing more than killing jobs. It’s a cemetery for jobs at the E.P.A.”
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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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