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This section is devoted to an overview and summary of my own personal experiences as to the "big picture" regarding
and has certainly provided me with some very frightening and "enlightening" information. These are only my own experiences, my own personal opinions and my own personal conclusions drawn from my experiences in these areas and are not offered as any sort of "advice" - other people may have entirely different experiences should they try to find out how the how/why their dog died and/or was damaged and may come to different conclusions as to what the "big picture" is.
Veterinarians: To begin with, the reporting of an ADE [adverse drug event] is strictly a voluntary action on the part of veterinarians; there is no "law" requiring a veterinarian to make an ADE report and as such reporting an adverse drug reaction to either a drug manufacturer or to the FDA/CVM is based solely upon
PFIZER: While I don't know for a "FACT" that this applies to all drug companies, it is my understanding from the FDA/CVM that it does/did apply in the case of PFIZER, the company making/distributing RIMADYL that killed my dog:
the FDA/CVM: The FDA [for people/human use drugs and/or products and the FDA/CVM [for animal drugs] "monitors" ADE [adverse drug event] reports turned into them.
For openers neither the FDA nor the FDA/CVM will "guarantee" either the safety OR the "effectiveness" of ANYTHING that they "approve" for marketing. From my own personal experience, it has become very apparent that the only function they have with respect to ADEs is keeping a "doggie (body) bag" count.
In my 'dealings' with them, every single person I had contact with was a veterinarian or claimed to be one - apparently one needs to BE a veterinarian in order to count the "doggie (body) bags".
While I do not know this for a "fact", my understanding is that when an ADE report is filed with the FDA/CVM, one of the veterinarians enters the information provided into a data base and then based upon the information provided on the ADE report a system of "grading or scoring" is done - basically each symptom and/or condition provided in the ADE report is assigned a "number" as to how "likely" THEY BELIEVE there is a "connection" of the reported symptom and/or condition in relation to the administration of the drug being complained about. BECAUSE the FDA/CVM does not do any testing, research and or first-hand monitoring of any of the drugs they "approve" themselves, it is my opinion that the FDA/CVM is having to rely solely on the information provided BY THE DRUG COMPANY as to whether or not a specific symptom and/or condition might or might not be or have been attributable to the drug complained about.
For those of you who are either aware of or keeping up with the present Senate investigation hearings taking place regarding the issues of massive "conflicts of interest" and the scandals erupting almost daily in the "news" regarding the "cover-ups" and/or deliberate withholding of vital information BY the drug companies themselves that's not "positive" for the drugs on the market, this is certainly an interesting development being exposed. [see page entitled: "A Class Act" and the Drug News pages for more information and links].
THIS IS "ROCKET SCIENCE" THAT WE'RE SEEING HERE
the FOIA [Freedom of Information Act]: As you will see from the e-mail letter from the FDA/CVM, I am not allowed to have access to the ADE report turned in for ROMI without filing an FOIA letter [which I did on 12/08/04].
Now allegedly, the purpose FOIA filings for information is possibly that of the government performing a balancing act between allowing citizens to have information not normally available by other means and protecting an individual person's "privacy", so this is how it's been "working" in my situation:
It would appear that DVM Williams/Burien Veterinary Clinic filed an ADE report with PFIZER on 7/13/04 and in doing so had to have provided PFIZER with either actual the records and/or information from ROMI's medical records
PFIZER, on the other hand, was required to turn the information they had received from DVM Williams/Burien Veterinary Clinic into the FDA/CVM, but they did so by accepting private/personal medical records that DVM Williams was NOT entitled to have, much less "share" with ANYONE. As you can see from the below letter from PFIZER, I am not allowed to see what was provided to PFIZER without a court order, blah, blah, blah . . .
So much for any protecting of MY "privacy" with respect to what was provided for an ADE report.
The finalized ADE Reports: I have not yet received my "scored and/or graded" ADE Report from the FDA/CVM, but this is my understanding from folks who did receive their ADE reports as to what I can expect to receive.
Note: an example of what you receive from filing a FOIA ADE report request can be found at: http://www.dogsadversereactions.com/moxidectin/murphyFOIA.html. You can also request a copy of all records submitted to them, THEN the names etc. are blocked out. I was not able to make any "common sense" out of this "scored/graded" ADE Report myself, but then my "agenda" was/is limited by just trying to determine the TRUTH.
All information giving any name of any person and/or any entity will be REMOVED from the ADE Report. While removing all information regarding the names of any individuals from a "scored and/or graded" ADE report would protect the privacy of the involved individuals/entities IF the report was provided to anyone OTHER than those involved, removing this information from the "scored and/or graded" ADE report provided to the person that the records BELONG TO only serves to assure that the information is TOTALLY WORTHLESS for the purposes of "litigation". It appears to ME that the only real purpose that is served by the FDA removing the "personal" information from ADE "scored and/or graded" report provided to ME is to PROTECT both the drug company and the health care provider from any responsibility and/or liability issues.
With respect to Pfizer, the maker of Rimadyl, and the FDA/CVM, I saw a posting at the doghealth2 list on Yahoo about 9/10/04, in which someone had posted an e-mail contact address for Pfizer with the statement that Pfizer could be contacted at that e-mail address IF the e-mail sender could/would 'talk rationally' about losing their dog.
I sent an e-mail requesting that they [Pfizer] tell me whether or not an ADE [adverse drug event] report had been done regarding my dog. The Pfizer contact person, a Dr. McKinnell at: hmckinnell@Pfizer.com responded by saying 'someone' [else] would be contacting me by e-mail with that information [Exhibit #87]. I then received an e-mail from a Dr. Wahlstrom at: PfizerAnimalHealthTechnicalServices@pfizer.com stating that an ADE had been reported by Dr. Williams to them on 7/12/04 [almost three MONTHS after my dog DIED, and exactly 30 DAYS after I provided all of the documents supporting the "allegations" contained in the WA Vet Board complaint to the Investigator, which filed on 4/29/04, Exhibit #86] and further stating that Pfizer had turned in an ADE to the FDA on 7/23/04. Dr. Wahlstrom stated in her e-mail that I could call her at 1-800-366-5288 if I wanted to 'discuss the matter'.
As I prefer to 'do business' via e-mail, so there's no question later as to 'what was said', I e-mailed her back requesting that they provide me a copy of both ADE reports [Williams' and Pfizers'] and any supporting documents, either by e-mail or by U.S. Mail, and to send me a bill for copy charges/postage, if any.
The e-mail was returned to me as 'not accepted' TWICE. [Exhibits #88 and #89]. I then sent a copy of my original request, Dr. Wahlstrom's reply and the returned e-mail notice to Pfizer's Dr. McKinnell, hmckinnell@Pfizer.Com, and to three  of the contact e-mail addresses at the FDA/CVM VHAMPSHI@CVM.FDA.GOV, MLarkins@cvm.fda.gov and RUMBLEW@cedr.fda.gov asking 'what must I do to get a copy of these documents?' [Exhibit #90] .
Pfizer did not respond; one of the FDA persons, VHAMPSHI@CVM.FDA.GOV, sent me an e-mail containing a link to the 'Manual' on how to file an FOIA Request [Freedom of Information Request] http://www.fda.gov/cvm/default.html [Exhibit #91], but without an FDA/CVM case number [NOT a Pfizer number], it's not possible to make the request and that request IF/WHEN one has the FDA assigned number can only be done by regular U.S. Mail along with a signed statement as to the maximum amount of money the requester is willing to pay for the research efforts to locate the document. Not having that much Excedrin on hand and not having that big of a grudge against myself, I called the 1-800-366-5288 number for Pfizer earlier today [9/16/04]: Dr. Wahlstrom was not available, and that she's 'on the road' traveling all over the country on behalf of Pfizer; I spoke to a gal named 'Debbie' who was able to give me a Pfizer case number, told me they didn't know what number the FDA might have assigned to 'my case', stated that there was NOTHING in the way of 'records' TO provide me with as it was 'all done electronically' and put into their 'database'. I asked her who I could speak to and she told me Dr. Radford was Debbie's supervisor, and when I asked that she connect me to Dr. Radford, she told me that Dr. Radford was on another phone call and that they would be 'closing down' soon for lunch - I then asked her if they didn't have any physical records, HOW had Dr. Williams provided them with an ADE and she said it was done by phone and then entered into the database and that was also how Pfizer provided the FDA/CVM with an ADE report, via telephone and the data base information was not available. I then asked her to see if Dr. Radford's call was finished yet and if she was now available to speak to me and she was.
My chat with Dr. Radford resulted in being told basically the same information as Debbie had provided and that she did not have the authority to determine if or what records I might be allowed to see/have and that would have to be decided by Dr. Wahlstrom [the one who's "on the road and unavailable"], so I asked her to make a note, forward all the information about what-all that I was requesting to anyone/everyone who might be able to help and to have someone/anyone get back to me via e-mail to advise whether they would provide me with anything and if so, what and when. Dr. Radford said she'd find out if she's allowed to research and I should get a response from her in 7-10 business days via e-mail. On Saturday, 9/24/04, I received a letter via U.S. Mail from Pfizer's Dr. Wahlstrom, dated 9/21/04, postmarked 9/20/04 and a true copy of the pertinent contents follows [Exhibit #92]:
* * * * * * *
September 14, 2004
Dear Ms. Sanchez ,
I have been asked to respond to the email, dated Sept 10, that you sent to Dr. McKinnel at Pfizer, Inc. I can tell you that the incident involving your dog Romy was reported to us by Dr. Williams on July 12, 2004. It was submitted to FDA by Pfizer Animal Health on July 23, 2004. If you wish to discuss this further please call the US Drug Safety group at 1-800-366-5288. You may ask for me, Dr. Tina Wahlstrom, Director US Drug Safety. I am unable to provide additional service over the Internet but would be happy to talk to you over the phone.
Dr. Tina Wahlstrom
US Drug Safety
812 Springdale Drive Exton, PA. 19341
* * * * * * *
After all of the DENYING by Williams/BVH, Hammond/Meyer/Five Corners and Murnane/Phoenix Central Labs as to even any POTENTIAL of Pfizer's drug Rimadyl being the 'culprit' leading to my dog's horrific death on 4/25/04, WHY EVER would Williams/BVH turn in an ADE report to Pfizer and do so almost three MONTHS after my dog DIED, and exactly 30 DAYS after I provided all of the documents supporting the "allegations" contained in the WA Vet Board complaint to the Investigator, on 6/14/04?
September 21, 2004
Re: case #2004EX07093
Dear Ms. Sanchez
You requested a copy of an adverse event report that has been submitted by Pfizer to the FDA, and received by Pfizer from your veterinarian, that pertains to a civil lawsuit in which you are involved.
FDA regulations, 21 C.F.R. 514(e)(4), require us to maintain the confidentiality of the "names and any information that would identify the person using the product" and the "names and any information that would identify any third party involved in the report, such as a physician, hospital or other institutions." Because of the existence of this regulation, Pfizer would require receipt of a formal subpoena for the report in order to comply with this request.
Pfizer agrees to accept service of any such subpoena by certified mail, return receipt requested, addressed to Dr. S. Kristine Wahlstrom. In order to assure fairness to all parties, the subpoena should be accompanied by a certificate of service indicating that it was also served on the adverse party, and providing the name, address and telephone number of counsel for the adverse party.
Dr. S. Kristina Wahlstrom
* * * * * * *
It is my own personal opinion that this entire program STINKS !
NOTE: only people with AOL can reach AOL news links, but where possible I have provided the "generic" links for access.
Pfizer is one of the most active drug makers. It is the top lobbying spender among health care interests. The industry devoted at least $85 million to lobbying Congress and the Bush administration last year. See: http://abcnews.go.com/wire/Politics/ap20040901_137.html
There is a potential for causing harm to public health and to animals when drug products are compounded, distributed, and used in the absence of adequate and well-controlled safety and effectiveness data or adherence to the principles of contemporary pharmaceutical chemistry and current good manufacturing practices. Use of compounded drugs in animals can result in adverse reactions and animal deaths. see: http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg608-400.html
Pfizer Reaches Agreement to Settle Rezulin Lawsuit in Illinois: see: www.pfizer.com, www.prnewswire.com [Exhibit #94 to WA Vet Board Complaint]
FDA Lawyer Collaborated With Drug Firms-Lawmaker: see:http://aolsvc.news.aol.com/news/article.adp?id=20040713212309990003 [Exhibit #95 to WA Vet Board Complaint]
FDA is Placing Corporations Above Public: see: http://www.house.gov/hinchey/issues/fda.shtml [Exhibit #96 to WA Vet Board Complaint]
Major FDA Warning? see: http://www.thomasjmoore.com/pages/drug_fda.html [Exhibit #97]
Pfizer Lawsuits - On July 23, 2004, a citizen's consumer protection lawsuit was filed against Pfizer Pharmaceuticals for concealment of evidence and deceptive marketing of the antidepressant Zoloft. The California law firm of Baum Hedlund has filed a suit against Pfizer on behalf of a doctor of public health / nurse and on behalf of "all California residents who have been misled about Zoloft." [press release below]
On May 14, 2004, Pfizer pleaded guilty in federal court to criminal fraud charges for the unlawful promotion and marketing of Neurontin by its predecessor, Warner-Lambert. Pfizer agreed to pay $430 million in settlement.
The New York, the law firm of Finkelstein & Partners, petitioned the US Attorney and the Judge who presided over the Neurontin case to consider the thousands of individuals who have been harmed - many died because their "doctors were fraudulently enticed to prescribe Neurontin." The letter noted that Pfizer "with full knowledge of the problem [ ] knowingly continued marketing the drug for unapproved, off-label conditions, thereby becoming criminally prosperous."
Andrew Finkelstein noted that the firm knew of 160 "Americans who, having never attempted any form of suicide before taking Neurontin, committed suicide while on the drug." Furthermore, he informed the court, he knew of "over two (2,000) Americans who, having never attempted suicide before taking Neurontin, were hospitalized following a suicide attempt while on the drug."
Finkelstein asked the court to hold Pfizer officials personally responsible:
"A prison sentence must be considered when so many lives have been damaged through a clear corporate program of criminal activity."
see: http://story.news.yahoo.com/news?tmpl=story&cid=580&e=3&u=/nm/20040903/bs_nm/health_pfizer_dc , and http://www.ahrp.org/infomail/04/07/26a.html [Exhibit #98 to WA Vet Board complaint]
"Black Hole" of medical research: Negative Results Don't get Published": The JAMA report notes that 80% of industry sponsored trials conducted at universities such as Yale, Hopkins, and others, are reported as positive, reflecting bias.
"In almost two-thirds of these cases, the results omitted concerns over potential harmful effects. Independent researchers were just as prone to bias as those funded by industry. Crucial information, from the intensity of pain to survival rates, was either downgraded in importance or omitted from the published report." . . . "The medical research community and its self-regulating system is dysfunctional; failing to protect the public from hazardous drugs and medical procedures, and tainting the credibility of the scientific literature with fraudulently manipulated findings." see: http://www.ahrp.org/infomail/04/06/05.html [Exhibit #99 to WA Vet Board complaint]
Ethical Violations/Pfizer: http://www.ahrp.org/ethical/EthicalViolations.php [Exhibit #100 to WA Vet Board complaint]
Press Release Pfizer Class Action Suit - RIMADYL: see: http://hometown.aol.com/sn1154/RIM2.html/ [Exhibit #101 to WA Vet Board complaint]; this is the press release for out of court settlement of the case against Pfizer because of Rimadyl deaths; the original complaint and Pfizer's Answer and Affirmative Defenses was provided previously as Exhibit #19 to WA Vwt Board Complaint]
"Vets May Not Warn You About Potentially Deadly Pet Drugs" see: http://www.kpho.com/Global/story.asp?S=2343141&nav=DIH7RGXh [Exhibit #102 to WA Vet Board complaint]
NOTE: See the "Drug News" pages for additional information on this subject.
May my beloved partner ROMI rest in peace - no matter wherever her bits and pieces/frozen carcass may be held hostage.
[what's in YOUR "urn" ?]
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