The Senior Dogs Project
"Blessed is the person who has earned the love of an old dog."
Outraged Consumer Cites Pfizer in Letter to "Public Citizen"
Copy of a letter to "Public Citizen" was delivered to the Senior Dogs Project concerning an incentive program for veterinarians, encouraging the sale of Pfizer Small Animal products, of which Rimadyl is one. The writer prepared the letter as a follow-up to Public Citizen's Outrage of the Month -- "Pfizer Caught Trying to Subvert National Guidelines for Treating Children's Ear Infections." Equally outrageous, the writer feels, is Pfizer's incentive program for veterinarians, captioned, "Loyalty Has Its Rewards." The program awards 10 points for every $1 of Pfizer dog and cat products purchased. It tells veterinarians, "You can earn points at a higher level based on the number of product categories in which you have purchased in excess of $1,000. Spend more than $30,000 overall, and you will qualify for a higher level even faster." The points are redeemable for ". . . practice accessories, medical and computer equipment, apparel, promotional items, and travel packages to important veterinary conferences."
If others are as outraged by this technique of marketing drugs as the writer ("Janet" in California), she invites them to send a letter to Public Citizen Health Research Group, 1600 20th Street N.W., Washington, DC 20009.
7/21/99 Concern Expressed about Dogs Used in Rimadyl's Clinical Trials
"I just became aware that the dogs used in the studies of Rimadyl's effectiveness and toxicity were given doses many times the normal dose, causing distress and, in some cases, death. I wondered if they were from shelters. I never thought about the poor 'research' dogs when I purchased Rimadyl. But I have now promised myself to try to avoid drugs for my dogs unless they are absolutely necessary. I will try the natural route as much as is humanly possible. My dogs (all from shelters) could easily have been among those used for Pfizer's clinical trials."
5/30/99: Advice Sought for Young Dog with Hip Dysplasia
"My husband and I share our life with our beautiful, not-quite-three-year-old Golden Retriever, Konteka ('Teka'). A couple of months ago, she was diagnosed with hip dysplasia. The vet recommended putting her on Rimadyl until we had the financial resources to do hip surgery. We started her out on 100mg, twice/day, AM and PM. After a few weeks, he suggested experimenting with the dosage to find the minimum that would keep her comfortable and pain-free. I found 100mg in the AM and 50mg in the PM seemed to be the best. She was happy and lively. After about 4-6 weeks on the drug, our groomer suggested I search the Internet to learn about possible side effects of Rimadyl. Teka had not had any side effects from taking Rimadyl, but there were so many awful stories that my husband and I took her to the vet for a full blood panel. Happily, everything checked out 100% okay, and Teka is as healthy as a horse, with the exception of the hip dysplasia. We have taken her off Rimadyl and have her on Glucosamine and Chondroitin until we can afford the hip surgery. We would be very interested in hearing about the experiences of others who have dogs in a similar situation."
5/30/99: Alternative Medicine Preferred to Drugs
"Drugs are good when put in their place and not abused. I prefer to use alternative medicine -- to give natural medicine before a powerful drug that is relatively untested. I have a 16-year-old English Cocker Spaniel who still runs and takes flying leaps over mud puddles. I believe his good condition is due to the gentleness of alternative therapies. I have never had to turn to drugs for his arthritis.
Rimadyl, EtoGesic or "Cartrophen Vet"?
The Senior Dogs Project is frequently asked about the differences between Rimadyl and EtoGesic and whether one is better than the other. Like Rimadyl, EtoGesic is a non-steroidal anti-inflammatory drug; however, it appears not to cause the liver problems sometimes associated with Rimadyl. The jury is still out, but here is one very interesting report posted to the Senior-L list by Dr. Bonnie Anthony about her Labrador Retrievers:
"I have my beloved Hershey on EtoGesic and my beloved Cinder on Rimadyl. . . . Hershey has had NO side effects whatsoever from the EtoGesic, and Cinder has had plenty of gastric upset from the Rimadyl, although she has had no liver problems. She vomits at least once every few weeks, whereupon we withhold the Rimadyl, she gets better in her GI system but worse in her arthritis and won't move, so we put her back on the Rimadyl. Hershey just ticks along. According to what I could glean from the manufacturers, EtoGesic has more GI upset than Rimadyl but fewer liver problems. No drug is side-effect free, so I guess it is simply a case of 'you pays your money and you takes your chances!' "
Another report received about a dog on EtoGesic: "We had a very good response. Used it for a week or so full dose, then tapered off to a very low dose, and now he isn't taking any except if he gets really stiff."
Last August, the FDA wrote a letter to Fort Dodge, the makers of EtoGesic, reprimanding them for their use of objectionable material in their promotion campaign for EtoGesic. The material apparently was misleading and not a fair presentation of the drug. Fort Dodge stopped distributing the material as a result of the letter.
Another drug for arthritis that is a "disease modifying" drug rather than a symptom reliever is known as "Cartrophen Vet." Currently, this drug is available in Canada, Australia, and other parts of the world, but not in the United States. We have this report on the drug from Richard Owocki (email@example.com) in Canada:
"I have an 8-year-old Border Collie named Megabyte. Just about a year ago his competition obedience marks went from 198's to 180's. He was always sitting off to one side. X-rays showed bad hips (HD) with the onset of arthritis. He started on .7cc of Cartrophen Vet once a week for six weeks and once a month ever since. I have seen no side effects. All I know is I have a pain-free Border Collie who enjoys Frisbee, agility, and racing around the fields with my other dogs. Cartrophen Vet has given Megabyte a second chance at what he loves to do. I feel all dogs everywhere should have that same chance."
4/12/99: Pfizer Ads Now Include Warning In Large-Size Type
The May 1999 issue of Dog Fancy magazine contains a full-page ad for Rimadyl. It was noted that, instead of the fine print that is normally used for safety warnings, the following sentence appears in full-size type in the ad: "As with other pain relievers in this class, rare but serious digestive and liver side effects may occur."
3/30/99: Is the FDA doing enough to keep drugs safe? We would like to bring to your attention an article that appeared on March 23 in the Washington Post that addresses the issue of whether the FDA is doing a good job of monitoring drug safety. An excerpt from the article: "Drug safety experts say the increased pace of drug approvals means that more problems are bound to make it onto the market. To guard against that, drug safety experts argue that more should be done to conduct follow-up studies on the safety of these drugs after they arrive on pharmacy shelves to catch problems early."
3/16/99: FDA's New Directive on Labels
From The New York Times, 3/11/99: "The Food and Drug Administration is about to order the drug industry to revamp the labeling on over-the-counter medications, a move that will do away with dense fine print on medicines from aspirin to cough syrup, replacing it with simple, and bigger, text that is similar to the nutrition labels on food packages. . . . Current labeling varies considerably by product, is often laced with legalistic prose and is difficult to read, particularly for the elderly. And while over-the-counter drugs are generally safe, their misuse causes more than 170,000 hospitalizations each year. . . . The warnings are to be written in plain, clear English."
Obviously, such labeling would be helpful if it appeared on the packaging for a drug such as Rimadyl. The FDA will accept comments on their notice concerning any matter that pertains to this directive. (You can read the directive at: http://www.fda.gov/cvm/fda/mappgs/whatsnew.html) This means that you may write to the FDA to state your concerns about the labeling for Rimadyl (and other medications for dogs). Here are excerpts from a letter written by Jane and Robert M. Sinclair, whose dog died of Rimadyl toxicity (Death #3):
Mukund R. Parkhie
Center for Veterinary Medicine
(HFV-216), Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
RE: Food and Drug Administration [Docket No. 99D -- 0254]
Reference: Federal Register Notices: March 12, 1999 (Volume 64, Number 48) Pages 12341 to 12342
The undersigned, Jane Sinclair and Robert M. Sinclair, strongly support the FDA Draft Guidance for Industry entitled Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling. We were the owners of a prize toy poodle who was so adversely affected by Pfizers veterinary drug Rimadyl (Carprofen) that she had to be euthanized June 8, 1998. In separate reports to the FDA dated October 30, 1998 and February 8, 1999 (copies enclosed) we indicated the following: We were misled by Pfizers emotive TV advertising of Rimadyl that continues to run on major networks and many cable channels. We were not advised of potential side effects of Rimadyl (Carprofen) by the prescribing veterinarian. We did not receive a Rimadyl (Carprofen) Patient Information Leaflet. The prescribing veterinarian never showed us a Rimadyl (Carprofen) Product Label. Rimadyl merchandising materials provided to veterinary practitionerscalendars, toy Rimadyl dogs, desk padsmake no mention of potential side effects. Pfizer promotional messages to veterinarians say that Rimadyl is safer than aspirin and good for your business.
Extensive research pursued after our dog died reveals that thousands of U.S. dogs have suffered serious toxic effects including death; that Rimadyl (Carprofen) received by far the greatest number (33.3%) of possibly drug-related ADE Animal Injury Reports in 1997; and that the frequency and severity of toxic reactions to Rimadyl (Carprofen) in overseas markets where the drug has been approved are less than in the U.S. Pfizers U.S. Rimadyl (Carprofen) Label Dosage is 110% of the Australia-U.K. Label Dosage for the first four days and 220% thereafter. In Germany and Switzerland the Label Dosage is similarly lower than the U.S. Label Dosage.
Our letters and reports are based on our experience with and research on Rimadyl (Carprofen), and include the recommendation that the FDA revise its fair balance of risk and benefit information policy and mandate that:
Consumer information prepared and supplied by the manufacturer must absolutely be delivered by veterinary providers to animal owners purchasing prescription drugs.
Any veterinary practitioner or drug supplier failing to provide such information to animal owners can be held in violation of this Federal Regulation.
The FDA will establish means to monitor compliance and will enforce this Regulation.
We also recommended that the FDA reinstitute its previous policy requiring that direct-to-consumer (DTC) advertising of prescription drugs in all media include a so-called brief summary of virtually all information, including hazards and contra-indications. FDAs August 8, 1997, easing of direct-to-consumer (DTC) broadcast advertising restrictions imposed on manufacturers of prescription drugs caused the Associated Press to report that Advertisers expect the TV advertising blitz to increase and Public Citizens Dr. Sidney Wolf to say publicly that,"Its out of control in January 1998.
We object to DTC ads that mislead consumers by not providing a complete picture of the drug. Purchasers and users of prescription drugs and biological products will benefit if the practices set forth in paragraphs II.A -- II.E and paragraph III of the subject FDA Draft Guidance for Industry are followed. The revision of the April 1994 Guidance that documents the applicability to animal prescription drugs and biological products is of particular importance to animal owners and their animals. It commands enthusiastic support.
The subject FDA Draft Guidance for Industry is a good step forward. Additional FDA Rule Making addressing the following areas is recommended: The advertising and merchandising practices of prescription drug manufacturers and their sales representatives who call on medical and veterinary practitioners. The communication of fairly balanced risk and benefit information by medical and veterinary practitioners to purchasers and users of prescription drugs.
Robert M. Sinclair
3/3/99: Report on a Long Conversation with Pfizer
"Pfizer obtained my screen name from the Senior Dogs Project website and sent me 'form' E-mail requesting that I call their 800 number about my experience with Rimadyl. (I had already filed a formal complaint with Pfizer and the FDA when my dog died of complications from taking Rimadyl.) I called the number and made contact with a Pfizer vet who explained that she had the complaint concerning my dog in front of her and wanted to know more about the circumstances and my experience with Rimadyl.
"I told the Pfizer vet that both my dogs had had serious side effects from the drug and gave the following history: My Mini-Schnauzer, Samantha, had had her routine physical and annual labs no more than a month before starting Rimadyl. All the lab results were normal, including liver and kidney function. During that routine vist to the vet, when I asked about relief for Samantha's arthritis pain, my vet told me that Rimadyl was completely safe for older dogs. She said that it was a great drug because there were virtually no side effects. In her words, it was a 'wonder drug.' Very shortly after beginning Rimadyl, Samantha began having seizures, walking in circles, vomiting, and being very lethargic. I took her back to my vet. She examined her, looked at the results of the lab tests that had been done just a few weeks earlier, and told me that there just wasn't anything wrong with her. She said the symptoms I was seeing were attributable to old age (Sam was 13 at the time), and old age symptoms were to be expected. My dog didn't get better. She would vomit, have a seizure, and faint, falling in her own vomit. I took her back to my vet and asked if Rimadyl could cause these problems. My vet was adamant that Rimadyl does not produce these symptoms; she told me again that Sam's problems were due to her age. I didn't agree. I took her off the Rimadyl and started doing research. I discovered that my dog had every damaging side effect Rimadyl can produce. Two weeks later, I had to put her to sleep, as new lab tests revealed liver and kidney failure. There was nothing I could do to save my dog. Not only had she been dying, she had been dying a horrible and painful death. In three months' time, my dog went from being a healthy dog with completely normal liver and kidney values to a dog dying a death no animal should suffer.
"After I finished telling this story to the Pfizer vet, she explained that once in a while Rimadyl causes hidden liver problems to 'crop up' unexpectedly. I said that I had a hard time believing this as, less than a month prior to Rimadyl, my dog was absolutely fine with NO liver or kidney problems. I also reminded her that when I originally filed my complaint with Pfizer and the FDA, both had agreed that Rimadyl was indeed the cause of my dog's death. The vet finally conceded that this was probably very likely.
"Then I told her about my other dog, a Shih Tzu who was 7 at the time. I explained that although he was on Rimadyl, he was not on it as long as Samantha had been. I explained that after what happened to Samantha, I had serious concerns about my Shih Tzu, so I took him to the vet for tests to see if he, too, had problems. He did: his liver was compromised due to Rimadyl. She asked how I knew Rimadyl was the cause. I couldn't believe she asked the question, but I replied that, several weeks prior to taking Rimadyl, both my dogs were fine. After taking Rimadyl for a very short period of time, one was dead and the other had the exact symptoms and similarly alarming test results. She again explained that Rimadyl sometimes uncovers previously-hidden liver disease. I again explained that I didn't buy that. After some discussion, she finally conceded that Rimadyl does cause some dogs to go into liver failure, even when there is nothing wrong with them prior to its use.
"She then asked if I would be willing to submit my dog to a liver biopsy at the expense of Pfizer. She said that I could use the vet of my choice and they would pay the entire bill. I asked her why I should do that. She explained that Pfizer was doing further testing to show that problems with liver disease and Rimadyl are due to a pre-existing liver condition. I asked her if kidney problems from which dogs were also dying were also considered 'pre-existing.' She said she didn't know. I told her I would not entertain the idea of subjecting my dog to a painful and invasive procedure just so Pfizer could try to prove their case. My dog had NO liver problems before taking this drug. I would not offer him as a subject for the collection of data that Pfizer would manipulate to serve their own ends.
"She asked what the medical bills totaled for my Mini Schnauzer and Shih Tzu to this point. I told her I really didn't know. I hadn't kept track. She said there was a fund to assist in paying for medical bills and autopsies. I asked her why Pfizer felt it was necessary to pay vet and autopsy bills for dogs taking a 'safe' drug. She said that they were merely ensuring quality care. I asked her how paying for an autopsy was ensuring quality medical care--wasn't that a little late? I told her I wasn't interested in their money. I just wanted them to be totally honest with pet owners about this drug, without being forced to do so by the FDA.
"She explained Pfizer had gone to great lengths to educate vets about 'potential' problems with this drug. I asked her why her own sales reps were telling vets in my area that Rimadyl was 'safe and effective' when, in reality, there are some serious safety questions. She said she wasn't aware that reps were misinforming vets. I offered to give her names of vets I have talked to who have told me Pfizer sales reps insist this is a safe drug, especially for older and fragile dogs. She said she would be interested in this info. She asked for their phone numbers. I told her I didn't know their numbers, but I could give her their names and she could call Directory Assistance for the numbers. She told me she really didn't know if she could find them that way. I asked her if she was telling me she was unable to call Directory Assistance. If she wasn't willing to pick up the phone to call Directory Assistance, I had little confidence she would do any follow up at all.
"I asked her how many Pfizer drug salesmen her company had in my area. She said she didn't know. I asked her if she thought it would be about one or two. She said that sounded about right. I asked her if she thought she might be able to contact these two drug reps to find out why they were not fully informing vets about the potential side effects of Rimadyl. She mentioned mailings and label changes they had made to educate vets. What good does it do to send out literature and information via mail, just to have Pfizer's own reps ignoring or contradicting it? She said she didn't know that was the case. I reminded her that these people worked for her company. If there are only two in my area, I had a really hard time believing she would be unable to contact them. She finally agreed that perhaps that might be an idea.
"At this point, she asked me if I felt I was satisfied with Rimadyl. I was so angry I could hardly speak. I told her I now had one dead dog and another one with major liver problems due to their drug, so how satisfied did she think I was? She apologized and admitted that was probably a bad question. She told me that Pfizer really 'cares' about their consumers, and they 'care' about the quality of medical care that animals receive.
"She wanted to know how my Schnauzer was doing now. I told her that although I certainly appreciated her 'deep care and concern,' perhaps I needed to remind her that the dog she was so concerned about was dead. She had the formal complaint in front of her; if she had taken the time to read it, she would have realized that a dead dog doesn't do well at all. At this point I was very angry, and I felt this conversation was nothing but a poor attempt at PR on Pfizer's part.
"I do not believe they care if my dog is dead; I do not believe they care about the way my dog died; and I surely don't believe they care that my dog died due to Rimadyl. I hung up on her."
3/1/99: Owner of Newfoundland Requests Others' Comments and Thoughts on Symptoms Not Usually Associated with Rimadyl Toxicity
Breed: Newfoundland (male, "Blue")
Age: 7 years 5 months
Reason for Rimadyl rx: hip dysplasia and arthritis
Dog's weight and dosage taken: 100 mg 3 x daily
When reaction occurred following initial dose: througout period of administration and afterwards
Symptoms: diarrhea, hunched spine, sideways walking pattern, inability to support hind quarters, hair loss, panting, enlarged prostate; condition seemed to worsen by the hour
Date of episode: December 26, 1998 to February 23, 1999
Date of death: February 23, 1999
Did vet seem informed & inform you about side effects? Not clear
Owner's Remarks: "By February 11, 1999, we had seen no improvement in Blue. He was becoming lethargic and his gait became alarming to us. Rimadyl was now stopped. He was re-x-rayed (he had been x-rayed one month prior). Our vet and an orthopedic surgeon said they saw no change in his x- rays, which is curious because he was getting sicker and could not walk well, yet the x-rays did not substantiate a worsening case of hip dysplasia and arthritis. Our vet also took blood and urine samples again. Blood and urine samples had also been taken about one month prior. Both times these tests revealed nothing abnormal. One-and-one-half weeks later, Blue could no longer walk. We are not sure if our Blue was poisoned by Rimadyl, but we cannot understand how he became so ill in such a short period of time. We would appreciate anyone's thoughts and comments and hearing from anyone whose dog has exhibited similar symptoms or has passed away under similar circumstances."
Diane & Tom
Misguided Dispensing of Rimadyl?
E-mail from a veterinary assistant: "I work at a veterinary Emergency Room, and we dispense Rimadyl to some patients, but the vets here are VERYcareful to warn of side effects. I am shocked every day, however, at the number of dogs that come into our clinic for various reasons and have been put on Rimadyl for things that possibly could have been dealt with more conservatively. Just the other day, a 17-month- old St. Bernard came into Emergency for attention. While talking with the owner, it was revealed that the dog was being treated by his regular vet for panosteitis, and that the dog was being given Rimadyl for it. Panosteitis is otherwise known as 'wandering lameness' or 'growing pains.' It is a condition of unknown cause in large and giant breeds. Without getting too clinical, it essentially causes pain and lameness in young, growing dogs. It can appear in only one limb or rotate among the limbs (hence, 'wandering') or appear in all limbs simultaneously. It can sometimes be severe (though this is rare). Dogs usually respond to short courses of aspirin or phenylbutazone and cage rest. It normally goes away on its own. I am not saying that Rimadyl is inappropriate, but it is fast becoming the treatment of choice. My point is, rather, is it overkill? (No pun intended.) Do the vets that are prescribing it realize the possible harm they may cause by treating a rather benign (in most cases) condition that will go away with time with a drug that can cause permanent liver/kidney dysfunction or death? Are they so ill informed (I think so) or do they feel this is an acceptable risk?"
Report on an Alternative to Rimadyl:
Breed: Shepherd/Rottie Mix (male, "Max")
Age: 7 years
Reason for Rimadyl rx: hip dysplasia
Length of time on Rimadyl: 3 months
Alternative used/description: "We first started Max on Rimadyl for three months. During the last month we suplemented Rimadyl with a product called 'Osteo Bi-Flex.' It has Glucosamine and Chondroitin in it. This product is for humans with joint problems. It helps to promote cartilage regeneration. We tried Max on just the Osteo Bi-Flex and never went back to Rimadyl. We give Max 4 tablets once per day when we feed him. Each tablet contains: Glucosamine....250 mg and Chondroitin....200 mg.This is the fourth month that Max has been on it. He seems to be doing just as well as, if not better than, when he was taking Rimadyl. The product is available at WalMart."
Cliff Pettus <wcpettus@WCTEL.NET>
(Coordinator's Note: A discussion of alternatives to Rimadyl, such as glucosamine and chondroitin, appears on the Alternative Therapies page. Click on the link in the navigation bar at the left.)
Owner of a Hunting Dog Writes about the Promotion of Rimadyl
"I have just read the site regarding hunting dogs and the use of Rimadyl. I am disheartened to read the statistics that are being batted around to show that Rimadyl is the best thing yet in treating arthritic dogs! I speak from experience: Rimadyl can kill and does kill innocent hunting dogs and many other breeds and types, as well. Our beloved Abigail succumbed to suspected Rimadyl poisoning in May of this year. She was a glorious black lab with a heart as big as the outdoors and a nose that never lost a downed bird. She was the best upland game dog we have ever owned and her loss has taken a great toll on us. In fact, I didn't even go bird hunting this year. It was too hard. Our vet, whom we have trusted implicitly, had never had a dog with an adverse reaction to the drug and wasn't aware that dogs had actually died from the use of this wonder drug. We learned from the Senior Dogs network after her death that this happens more times than Pfizer would like to admit. We need to get the word out to all vets and dog owners that severe reactions do happen and deaths do occur. We all need to know about the screenings that need to be done to assess a dog's ability to tolerate this drug before the drug is prescribed. The small print on the insert that comes with the drug does a great job of disguising what pre-screening should be done and what symptoms to watch for in the case of reactions to the drug. I know that this E-mail sounds emotional, but that's exactly what it is. Our Abigail might still be with us if we had had access to the information we needed to make a wise decision about whether or not to administer Rimadyl."