Filthy Pfizer

Why Are Pfizer's Ghostwritten Hormone Therapy Articles Not Retracted?

2010-02-03T13:45:00.000-08:00

http://www.opednews.com/articles/Why-Are-Pfizer-s-Ghostwrit-by-Martha-Rosenberg-100202-181.html

February 2, 2010
By Martha Rosenberg

Plagiarism, "unethical research" and unreliable findings from "fabricated data" are grounds for retraction of medical journal articles according to the Committee on Publication Ethics (COPE).

But one look at the US National Library of Medicine database reveals that bogus, ghostwritten papers Wyeth (now Pfizer) planted in medical journals in a scandal which reached the US Congress last year, still stand, unretracted.

"Is there an association between hormone replacement therapy and breast cancer?" asks an unretracted article in the Journal of Women's Health, 1998 Dec;7(10):1231-46--a question a fourth grader could answer in the affirmative.

The "author" William T. Creasman, MD, neither wrote or initiated the article but was suggested by Jeff Solomon of Wyeth, according to documents posted on the University of California, San Francisco's Drug Industry Document Archive (Dida) http://dida.library.ucsf.edu.

The article which finds--surprise--no "definitive evidence" of a cancer link was written by an operative of DesignWrite, Wyeth's marketing firm, named Karen Mittleman.

How about Wyeth's "The role of hormone replacement therapy in the prevention of postmenopausal heart disease," in the Archives of Internal Medicine, 2000 Aug;14-28;160(15):2263-72--a role medical professionals agree should be none at all since hormone therapy increases cardio risks?

Lori Mosca, MD, PhD agreed to be "author " 11 months after the outline was completed by freelance writer E. Wesselcouch according to posted documents.

How about the unretracted "The role of hormone replacement therapy in the prevention of Alzheimer disease," in the Archives of Internal Medicine, 2002 Sep 23;162(17):1934-42? Is the fact that hormone therapy doubles dementia risk and a freelancer named Stella Elkabes wrote the outline for $2,300 a mere detail?

"Attached is the outline for your review in the hope you will agree to author," wrote Alice Conti, another Wyeth operative, to "author" Howard M. Fillit, MD.

Then there's the unretracted "Mild cognitive impairment: potential pharmacological treatment options," in the Journal of the American Geriatrics Society, 2000 Apr;48(4):431-41, by Barbara Sherwin, which also misrepresents dementia risk. Minutes from a Wyeth meeting three months after the article was written by freelance writer F. Karo ask, "Has initial contact been made with Dr. Barbara Sherwin for Memory paper?"

It's no secret journal editors prefer taking an article offline or behind an access barrier to jeopardizing ad sales, article reprint sales and author relations by admitting error. Nor do academic institutions want to admit they harbor pharma compliant doctors like New York University whose Lila Nachtigall, MD collaborated with Wyeth on many ghostwritten papers according to Dida documents.

Eight months after Sen. Charles E. Grassley of Iowa revealed the scientific con, NYU vice president for public affairs Deborah Bohren told the New York Times the university had not investigated because, "we have not received a complaint." Doesn't a probe from the chairman of the Senate Finance Committee qualify as a complaint?

So, even though hormone therapy increases the risk of breast cancer by 26 percent, Dr. Creasman's article, which finds "data fail to provide definitive evidence that the use of postmenopausal HRT is associated with an increased incidence of breast cancer," is part of the literature on which physicians train and practice is based.

Even though hormone therapy increases the risk of heart attack by 29 percent, Dr. Mosca's "cardioprotective" piece stands.

And even though hormone therapy doubles the risk of dementia and actually "decreases brain volumes," according to the Women's Health Initiative Memory Study, Dr. Fillit's Alzheimer paper stands--as does Dr. Sherwin's cognitive impairment paper which has been cited 50 times.

Wyeth and DesignWrite's ghostwriting scheme was not hidden from doctors.

"We are working on a review paper on diabetes and HRT," writes Mittleman to William Cefalu, MD in one memo. Would you "be interested in working with us as the author of this paper?"

Nor was it hidden from journal editors who eagerly correspond with DesignWrite as it "repped" doctor authors, archived documents show.

Hormone therapy represents one of the largest swaths of preventable injuries to healthy citizens in recent history with thousands of women developing cancer and other deadly side effects. Yet Wyeth/Pizer maintains it doesn't know how the idea that hormone therapy could prevent heart disease and dementia and provide other "benefits" ever got started.

One look at Dida archives shows how the "idea" got started. And the scores of unretracted papers in the medical literature show how the ideas persist.

Pfizer Acquires a Stem-Cell Therapy

2009-12-25T16:53:00.000-08:00

http://dealbook.blogs.nytimes.com/2009/12/21/pfizer-acquires-a-stem-cell-therapy/

DECEMBER 21, 2009, 5:13 AM
Pfizer Acquires a Stem-Cell Therapy

Pfizer said Sunday that it was buying the rights to a somewhat controversial cell therapy from Athersys, a biotechnology company — a sign of big pharmaceutical companies’ growing interest in stem cells, The New York Times’s Andrew Pollack reported.

Pfizer will have the rights to develop Athersys’s cells to treat inflammatory bowel disease, the companies are expected to announce on Monday. It will pay Athersys $6 million initially and up to $105 million in the future.

The relatively small payment reflects that “it’s really early for cell therapy and there’s more research to be done,” said Ruth McKernan, chief scientific officer of Pfizer Regenerative Medicine, a unit created by the company about 18 months ago to develop treatments based on stem cells.

Athersys’s cells, derived from human bone marrow, have not yet been tested in people with inflammatory bowel disease, a term that encompasses ulcerative colitis and Crohn’s disease. But the product, called MultiStem, is in early human testing as a treatment for heart attacks and for cancer patients receiving bone marrow transplants.

Athersys, founded in 1995 and based in Cleveland, is publicly traded and still unprofitable. Its shares closed at $1 on Friday.

Stem cells can form different types of tissue in the body. Pfizer and Athersys envision the cells being infused into patients not to replace damaged tissue but rather to produce various proteins that would help existing tissues heal or prevent them from being damaged.

Stem cells derived from adult tissues, like MultiStem, are less ethically controversial than stem cells from human embryos. But MultiStem has been dogged by scientific controversy.

The cells were initially developed at the University of Minnesota, which said they were multipotent adult progenitor cells — almost as versatile as embryonic cells. But some scientists had trouble replicating those findings, and some papers published by the Minnesota researchers were retracted or corrected.

Dr. McKernan said that those controversies were “in the past now” and that scientists have been able to replicate the findings.

Big pharmaceutical companies have been cautious about stem cells because of the ethical controversies and the early stage of the research. Also, some cell-based therapies must be tailored to each patient, a departure from the business model of producing one-size-fits-all pills.

But as the science of stem cells has advanced, drug companies are taking an interest.

Pfizer is also developing a stem-cell treatment for macular degeneration, an eye disease, working with University College London. It is doing research with Novocell, a San Diego company trying to turn embryonic stem cells into insulin-producing cells to treat diabetes.

Novo Nordisk is working with Cellartis on stem-cell treatments for diabetes. Johnson & Johnson has invested in Novocell and Tengion, another regenerative medicine company. GlaxoSmithKline is providing $25 million to Harvard’s stem-cell institute. And Novartis and Roche have invested in Cellerix, a Spanish stem-cell company.

Pfizer caught in yet more science fraud

2009-12-09T08:38:00.000-08:00

http://www.NaturalNews.com/z027692_science_fraud_Neurontin.html

December 9 2009
Pfizer caught in yet more science fraud: Company altered study findings for Neurontin drug
by E. Huff, staff writer

(NaturalNews) Research into internal company documents has revealed that Pfizer Inc., the world's largest research-based pharmaceutical company, tampered with the results of at least 16 study reports about its epilepsy drug, Neurontin. In order to expand the market for the drug, Pfizer unlawfully removed, altered, and changed published study findings that revealed unfavorable results.

Of the 20 study reports that were produced, eight of them were not published in medical journals at all and another eight had their original study designs altered in some way in order to arrive at alternate outcomes. Some of the primary outcomes were changed to new ones while others were replaced by secondary outcomes. Still others were simply removed altogether.

The scheme of off-label prescribing
Pfizer practices a strategy that most, if not all, drug companies employ. Following the approval of one of their drugs for a specific use, drug companies will continue sponsoring clinical trials on other possible uses in order to expand their drug market. Though not technically allowed to market their drugs for unapproved uses, drug companies will distribute information to medical professionals about the results of these additional studies that favor expanded drug uses.

In order to arrive at favorable results, industry-funded research trials are often altered, forged, and manipulated to suit the cause, as was the case with Pfizer.

When Pfizer was sued back in 2004 for illegally promoting Neurontin, it settled the case for $430 million. Expert witness Kay Dickersin of Johns Hopkins University was able to obtain the documents revealed in her study while serving for the case. Just last year, Pfizer was sued again using the original case as well as being accused of manipulating study data.

If a drug company wishes to change the goal of a particular study once it has begun, it must be done formally through an official amendment. The fact that most of the time this does not happen indicates that deceitful activity is taking place.

Dickersin suggests mandatory submission of study protocols and primary endpoints when companies register clinical trials in the public database. This will help to hold the drug companies accountable for their undertakings and eliminate the tendency to alter data through dishonest means.

Drug companies should also continue to be prosecuted to the full extent of the law for their violations. Harsher penalties for blatant violations should be implemented in order to reign in the violators and restore the integrity of the clinical trial process.

Huge Loss for Synthetic Hormones in Court Case

2009-12-07T06:41:00.000-08:00

Effective October 15, 2009 Pfizer Inc. acquired Wyeth in a cash and stock merger.

http://www.opednews.com/articles/Huge-Loss-for-Synthetic-Ho-by-Jeffrey-Dach-091204-832.html

December 7, 2009
Huge Loss for Synthetic Hormones in Court Case
By Jeffrey Dach

A 112 million dollar punitive award says loudly that the jury was outraged by the "wanton and reckless” conduct by Wyeth for peddling a cancer causing pill.The punitive damages were awarded to two breast cancer victims who took Wyeth's synthetic hormone, Prempro, all the while thinking itsafe. The jury was outraged that Wyeth ignored and suppressed evidence that Prempro causes breast cancer. Wyeth paid consultants and ghostwriters of medical journal articles to play down concerns about breast cancer, and declined to study known risks. Once again, company profit was placed ahead of patient safety. This is the tip of the iceberg, as another ten thousand cases are waiting for their day in court.

Women's Health Initiative Bombshell

Seven years ago, a bombshell appeared in the medical literature, and massive numbers of women switched from Prempro to safer bio-identical hormones. This was the 2002 WHI study which showed that PremPro causes breast cancer. This massive shift away from synthetic Prempro reduced breast cancer rates dramatically. (NEJM Volume 356:1670-1674 April 19, 2007 Number 16), and women shifted to safer and more effective bioidentical hormones.

The American Public Hoodwinked For 65 Years

This Prempro court case teaches us an important lesson. When a "Bad Drug" like Prempro gets FDA approval and placed on the market, what happens? The public is hoodwinked, and the drug company profits handsomely. The wheels of justice turn slowly. After 65 years and thousands of victims, our court system has finally ended a bad drug, in this case, a synthetic hormone called Prempro.

Another Important Lesson - Don't Use Synthetic Hormones

Another important lesson from this case is that synthetic hormones like Prempro, which are chemically altered versions of human hormones, are all "Monster Hormones" which should never have been approved by the FDA in the first place. Any alteration in a chemical structure of a hormone creates a Monster, and in the case of Prempro, the result is increased cancer and heart disease.

Changed Chemical Structure Results in Monster Hormones

The drug companies changed the chemical structure of human hormones to obtain patent protection and maximize profits. Human bioidentical hormones cannot be patented because they are found naturally in the human body, therefore they are not profitable for the drug companies.

Just Another Round in the Medical Information War

Drug companies routinely use their influence to control information in the mainstream media and the medical journals. They downplay adverse side effects of their products in order to maximize profits. This is merely part of the Medical Information War played out in the media every day.

Bioidentical Hormones Vindicated as Safe and Effective

This case highlights another important lesson. While the chemically altered synthetic hormones like Prempro are dangerous, the original version from nature, called Bioidentical hormones are safe, effective and beneficial for health. Read more about the evidence for safety, and health benefits of bio-identical hormones here:

The Importance of BioIdentical Hormones

The Safety Of Bio-Identical Hormones

The Evidence for Bio-Identical Hormones

Here is an important article on HRT by Jonathan Wright MD, the originator of bioidentical hormones. Read it here:

FDA approved HRT- Prempro is Risky by Jonathan Wright MD written in 2003.

Links to Related Content:

Iodine Treats Breast Cancer, Overwhelming Evidence by Jeffrey Dach MD

BioIdentical Hormones Trashed by Marilynn Marchione AP News

For illustrations and references see
Original Article

Pfizer to Leave City That Won Land-Use Case

2009-12-04T11:20:00.000-08:00

http://www.nytimes.com/2009/11/13/nyregion/13pfizer.html

November 13, 2009
Pfizer to Leave City That Won Land-Use Case
By PATRICK McGEEHAN

From the edge of the Thames River in New London, Conn., Michael Cristofaro surveyed the empty acres where his parents’ neighborhood had stood, before it became the crux of an epic battle over eminent domain.

“Look what they did,” Mr. Cristofaro said on Thursday. “They stole our home for economic development. It was all for Pfizer, and now they get up and walk away.”

That sentiment has been echoing around New London since Monday, when Pfizer, the giant drug company, announced it would leave the city just eight years after its arrival led to a debate about urban redevelopment that rumbled through the United States Supreme Court, and reset the boundaries for governments to seize private land for commercial use.

Pfizer said it would pull 1,400 jobs out of New London within two years and move most of them a few miles away to a campus it owns in Groton, Conn., as a cost-cutting measure. It would leave behind the city’s biggest office complex and an adjacent swath of barren land that was cleared of dozens of homes to make room for a hotel, stores and condominiums that were never built.

The announcement stirred up resentment and bitterness among some local residents. They see Pfizer as a corporate carpetbagger that took public money, in the form of big tax breaks, and now wants to run.

“I’m not surprised that they’re gone,” said Susette Kelo, who moved to Groton from New London after the city took her home near Pfizer’s property. “They didn’t get what they wanted: their development, their big plan.”

Ms. Kelo lived in a small pink house in the Fort Trumbull section that was square in the sights of city and state officials who wanted to revitalize the area. The city had created the New London Development Corporation to buy up the nine-acre neighborhood and find a developer to replace it with an “urban village” that would draw shoppers and tourists to the area.

Economic development officials in Connecticut used that plan — and a package of financial incentives — to lure Pfizer to build a headquarters for its research division on 26 acres nearby. With an agreement that it would pay just one-fifth of its property taxes for the first 10 years, Pfizer spent $294 million on a 750,000-square-foot complex that opened in 2001.

By then, Ms. Kelo, the Cristofaros and several neighbors had sued the city to stop it from using its power of eminent domain to take their property. The lawsuit, Kelo v. New London, wound up at the Supreme Court in 2005 as one of the most scrutinized property-rights cases in years.

In a 5-to-4 decision, the high court ruled that it was permissible to take private property and turn it over to developers as part of a plan to bolster the local economy. Conservative justices, including Clarence Thomas, dissented. Justice Thomas called New London’s plan “a costly urban-renewal project whose stated purpose is a vague promise of new jobs and increased tax revenue, but which is also suspiciously agreeable to the Pfizer Corporation.”

The decision was widely criticized, and spurred lawmakers across the country to adopt statutes to prevent similar uses of eminent domain. Scott G. Bullock, senior attorney at the Institute for Justice, a libertarian group in Arlington, Va., said that 43 states had moved to protect private-property rights since the Kelo decision. New York and New Jersey are among the seven that have not, he said.

Mr. Bullock, who represented the landowners in New London, said Pfizer’s announcement “really shows the folly of these plans that use massive corporate welfare and abuse eminent domain for private development.”

“They oftentimes fail to live up to expectations,” he added.

For its part, Pfizer said it had no stake in the outcome of the Kelo case nor any interest in the development of the land that was acquired by eminent domain, according to a statement provided by a spokeswoman, Liz Power.

After Pfizer completed its $67 billion acquisition of Wyeth, another drug giant, in October, Ms. Power said, “We had a lot of real estate that we had to make strategic decisions about.” She said Pfizer would try to sell or lease its buildings in New London and would “continue to pay our taxes to the city as scheduled.”

The complex is currently assessed at $220 million, said Robert M. Pero, a city councilman who is scheduled to become mayor next month. The company pays tax on 20 percent of that value and the state pays an additional 40 percent, Mr. Pero said. That arrangement is scheduled to end in 2011, around the time Pfizer, which is currently the city’s biggest taxpayer, expects to complete its withdrawal.

“Basically, our economy lost a thousand jobs, but we still have a building,” Mr. Pero said. Then again, he added, “I don’t know who’s going to be looking for a building like that in this economy.”

Some residents said they expected Pfizer to seek a revaluation of its buildings if they wind up vacant in two years; Ms. Power declined to comment.

Mr. Pero said that he was offended that Pfizer did not notify city officials about the decision before Monday or give them a chance to argue against it or even fully understand it. But he said he did not regret the decisions he and other elected officials had made to bring Pfizer to New London for what they had hoped would be a long and fruitful stay.

“I’m sure that there are people that are waiting out there to say, ‘I told you so,’ ” Mr. Pero said. “I don’t know that even today you can say, ‘I told you so.’ ”

But Mr. Cristofaro and Ms. Kelo both said just that.

Ms. Kelo, a nurse who works in New London and Norwich, Conn., said she was still bitter about the loss of her house, which she sold for $1 to Avner Gregory, a preservationist. Mr. Gregory dismantled the house and moved it across town. It now stands as a bright-pink symbol of the divisive dispute that drew so much attention to New London.

“In all honesty, I’m not happy about what happened to me,” Ms. Kelo said. But, she added, “With 43 states changing their laws, in that sense I feel we did some good for people across the country.”

Pfizer, Eminent Domain and America

2009-11-18T07:10:00.000-08:00

http://www.opednews.com/articles/Eminent-Domain-and-America-by-ALONE-091116-188.html

November 16, 2009
Eminent Domain and America
By Kevin Anthony Stoda

I have just heard of Pfizer Pharmaceutical's decision to leave New London, Connecticut. The state of Connecticut has done nothing to protect the citizens of New London abused by local usage of eminent domain for decades. Many other states have been concerned about run amok real estate and city planning practices in Connecticut, New York and other places in America. Americans are growing wary, but more must be done.

I would suggest all reader write the following emails: “Dear, Connecticut Government Leaders, Why not use Eminent Domain and take over Pfizer and all those big bad insurance companies that misuse America's total landscape?”

http://www.ct.gov/ctportal/taxonomy/taxonomy.asp?DLN=27537&ctportalNav=|27537|&ctportalPNavCtr=|27608|#27608

According to DEMOCRACY NOW, “Homeowners in New London, Connecticut [had taken] . . . on the city's leaders after they announced plans to condemn all of the homes in one neighborhood to make way for a private development project for pharmaceutical giant Pfizer. The city said it would bring in thousands of jobs. After a 2005 Supreme Court ruling against the homeowners, the entire neighborhood was bulldozed. This week Pfizer announced it is shutting down its research center.”

http://www.democracynow.org/2009/11/13/eminent

Dana Berliner is senior attorney at the Institute of Justice, and she had “represented the homeowners in Kelo v. New London, in which the US Supreme Court ruled that cities could condemn property because other uses may produce an increase in tax dollars and jobs.”

http://www.oyez.org/cases/2000-2009/2004/2004_04_108

Berliner noted that the Supreme Court, in its outrageous 2005 decision, refused to look at the facts on the ground that the ill-thought-out development-scheme involving Pfizer's expected commitment to the city of New London was absolutely not going to work.

http://www.ij.org/index.php?option=com_content&task=view&id=920&Itemid=165

The Supreme Court decision was so outrageous that over 20 US states immediately rewrote their own eminent domain laws to try to stop the horribly bad decision-making seen in New London “would and could not happen here”.

DN's Juan Gonzalez explained, “The proposed $75 million [New London] project was part of the city's efforts to spruce up the area for pharmaceutical giant Pfizer, which had agreed to construct a $300 million research facility adjacent to FortTrumbull. The city claimed the project would create 3,000 jobs. Several homeowners refused to give up their homes, and their case made it all the way to the Supreme Court. In June, 2005, the court ruled by a 5-4 majority that New London's seizure of the homes for private development was a permissible ‘public purpose.' The decision, Kelo v. New London, infuriated millions of property rights advocates across the country. After the decision, the neighborhood was bulldozed.”

From ZIMBABWE to Small TownAmerica--STERLING, KANSAS

http://www.huffingtonpost.com/2009/06/05/zimbabwe-whites-flown-bac_n_211858.html

Whenever I hear the words “eminent domain”, I almost always recall talks I have had with many white (and black) citizens from Zimbabwe who have had their properties seized over the past two or three decades under the Mugabe regime. For example, a judge in Zimbabwe had his farm taken personally by Robert Mugabe's wife early in 2009.

http://www.telegraph.co.uk/news/worldnews/africaandindianocean/zimbabwe/4447091/Robert-Mugabes-wife-Grace-seizes-Zimbabwe-farm.html

After these Zimbabweans have talked about their history with property seizures in their homelands, I have shared with these Zimbabweans that in America for decades real estate, business shylocks, and city developers have been abusing American property owners for years, i.e. using eminent domain and laws of condemnation to take property again and again.

In my family's case, in the mid-1990s, the small town of Sterling, Kansas (approx. 2000 residents) simply took over my mother's house and property—without even contacting her. You see, my mom had been divorced over 15 years earlier—a process through which the full property eventually became hers. In the early 1980s, there had been recession in property and job market throughout all rural areas in America, so the property often went unsold for years.

In short, my family had gone to neighbors all around the location of the house in Sterling over several years trying to sell the house to no avail. No one took the offer.

Meanwhile, my mom had been working for the United Methodists of Oklahoma continuously from 1980 through the end of the 1990s. (She had even become a minister first in the 1970s in Sterling, Kansas through the UM church there. Until late 1979, mom had been a minister in Kansas for the UM church, too.) In short, mom was a public individual in the Midwest and a simple background check through local, state or federal police would and could have provided the City of Sterling, Kansas with the phone number and address of my mother quite easily. They could have contacted her at the time the city took over the property, but they did not claiming that the owner could not be found.

Claiming to have been unable to find out where my mother lived,, Sterling city administrators took away my parent's old house for a pittance. So, the house and property were confiscated. The house was then torn down and the land was put up for auction. Only then, after the auction, was a 4 or 5 thousand dollar check sent to my mother in Oklahoma.

In conclusion, at auction my mom's property was sold to a neighbor--who had strong connections for years with the local city police.

BACK TO NEW LONDON

New London's Michael Cristofaro tearfully reported on Democracy Now, “Well, I mean, that [the intention of Pfizer to leave now] hurts even more, because, you know, the state and the city—you know, Pfizer came in. They [the real estate leaders, Pfizer, and city fathers] said what they would like to see happen, you know, to the neighborhood. And they had executives who basically said they didn't want to look out their tenements down at—I mean, look out their windows down at these tenements and, you know, ‘We would like to have a biotech buildings and office park there.' And so, that's what the city did. They accommodated them. And they gave them all these tax breaks.”

Cristofaro concluded, “And the hopes and dreams were that this PfizerGlobalResearchCenter was going to draw all these major corporations into New London, and it was going to save them, you know, by increasing the tax rolls. And here it is, ten years later, they actually extended tax abatements an additional three years to entice Pfizer to come here. And here it is, the tenth year, and the tax abatements are finally up, and they turn around and drop this bombshell, saying, ‘We are leaving.'”

In short, there never has been any justice and never will be any justice until more rigorous eminent domain laws are implemented in America. Moreover, the Supreme Court must support individuals over-run-amok city leaders and development mongers as it failed to do in the landmark 2005 case.

Wake up, America, fight for change and justice!!!!!

Dutch Authorities Halt Pfizer Vaccine After 3 Infants Die

2009-11-17T06:18:00.000-08:00

http://educate-yourself.org/vcd/dutchpullpfizervaccine05nov09.shtml

Dutch Authorities Halt Pfizer Vaccine After 3 Infants Die (Nov. 5, 2009)
http://www.msnbc.msn.com/id/33671008/ns/health-infectious_diseases/
Dutch pull Pfizer vaccine batch after infants die
110,000 doses of anti-infection drug Prevenar quarantined after deaths
Reuters
November 5, 2009

AMSTERDAM - Dutch authorities say they have banned use of a batch of Pfizer's Prevenar, or Prevnar, after three infants died within two weeks of receiving the anti-infection vaccination.

"On average about 5 to 10 deaths are reported annually after babies get vaccines," said a spokeswoman for the Dutch health institute RIVM.

"We now have three cases in a short period, that is unusual and the reason for suspending the batch."

She said RIVM was investigating the cause of the infants' deaths. Other batches of Prevenar, known as Prevnar in the United States, will continue to be used. Pfizer spokeswoman Gwen Fishersaid preliminary investigations by the company and health authorities had found no link between the vaccinations and the deaths.

110,000 doses of anti-infection drug

She said the company initiated the "quarantine" of the batch which she said contained 110,000 doses of Prevenar, used to prevent pneumonia and related infections. Fisher said the three infants also received two unrelated other vaccines as part of routine immunizations. No other Prevenar batches were suspended and infants in the Netherlands will continue to be vaccinated with it as part of routine immunization, she added.

A spokesman for the European Medicines Agency in London said its officials were working with the Dutch authorities to find out if there were any safety issues with the vaccine batch.

The vaccine is one of the most widely used in the world and generated sales for U.S. drugmaker Wyeth of $2.7 billion in 2008.

Wyeth, which has just been acquired by U.S. rival Pfizer, had asked for the suspension of batch D66977 of Prevenar, RIVM said in a statement.

Officials at Pfizer in New York could not immediately be reached for comment.

Copyright 2009 Reuters.

Pfizer pleads guilty to felony crime in fraudulent marketing of Bextra, pays billions in fines

2009-10-25T07:29:00.001-07:00

http://www.NaturalNews.com/z026963_Pfizer_Bextra_health.html

September 2 2009
Pfizer pleads guilty to felony crime in fraudulent marketing of Bextra, pays billions in fines
by Mike Adams, the Health Ranger, NaturalNews Editor

(NaturalNews) For the last several years, I've referred to drug companies as "criminal" operations. They have engaged in price fixing, marketing fraud, science fraud and many other criminal activities that we've written about here on NaturalNews. And yet, until today, they always managed to avoid the criminal charges by settling with the government for a few million dollars in payouts. This was their racket: Violate the law, then when you get caught, just settle with some cash. (And there's always some spare cash to go around since fraudulent science and fraudulent marketing is very, very lucrative.)

But all that changed today with the announcement of a Dept. of Justice criminal case that has resulted in Pfizer pleading guilty to a felony crime. Which crime? "...for misbranding Bextra with the intent to defraud or mislead." You can read the DOJ documents describing the settlement here: http://www.usdoj.gov/opa/pr/2009/Se...

Essentially, Pfizer asked the FDA to approve Bextra for a variety of diseases and conditions, and when the FDA refused those approvals, Pfizer decided to go ahead and market the drugs for those diseases and conditions anyway (off-label marketing).

But that's not all. In the DOJ statement, you'll read the following:

Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs -- Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug -- and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company.

False claims, kickbacks, felony crimes and civil fraud... it seems that the truth about pharmaceutical companies like Pfizer is finally starting to emerge.

And here's the best part: Pfizer's own whistleblowers will cash in! "Six whistleblowers will receive payments totaling more than $102 million from the federal share of the civil recovery," says the DOJ.

$2.3 billion in fines
Along with this admission of guilt for committing a felony crime, Pfizer is paying well over $1 billion in criminal fines, plus another $1 billion or so to resolve civil allegations against its fraudulent marketing practices. In all, the multi-billion dollar settlement is the largest in the history of the DOJ.

All I can say is: Good work! I've often stated that the pharmaceutical industry should be subjected to our nation's laws, and yet it has operated in a largely lawless fashion for decades. The FTC, for example, which should be investigating the drug industry monopolies that rip off American consumers and limit consumer choice, has all but ignored the monopolistic (and highly illegal) practices of the pharmaceutical industry. But the Dept. of Justice has now apparently decided that enough is enough -- it's going to investigate and prosecute serious criminal fraud being committed by drug companies.

It all makes me wonder whether the folks in Washington have finally figured out that Big Pharma is bankrupting America, and that if true health care reform is to have any hope of reeling in the runaway costs of "sick care," it's going to have to address the fraud and criminality of the pharmaceutical industry. You can't run a national health care system that's affordable and effective if a large part of the system is based on monopoly priced, fraudulently marketed and scientifically falsified drugs.

This is now becoming apparent at both the state and federal level. Check out these quotes from some of the players involved (quoted from the DOJ press release):

"Today's landmark settlement is an example of the Department of Justice's ongoing and intensive efforts to protect the American public and recover funds for the federal treasury and the public from those who seek to earn a profit through fraud. It shows one of the many ways in which federal government, in partnership with its state and local allies, can help the American people at a time when budgets are tight and health care costs are increasing," said Associate Attorney General Tom Perrelli. "This settlement is a testament to the type of broad, coordinated effort among federal agencies and with our state and local partners that is at the core of the Department of Justice's approach to law enforcement."

"This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs," said Kathleen Sebelius, Secretary of Department of Health and Human Services. "The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste."

"Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers, and costs the government billions of dollars," said Tony West, Assistant Attorney General for the Civil Division. "This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare."

"Health care fraud has a significant financial impact on the Postal Service. This case alone impacted more than 10,000 postal employees on workers' compensation who were treated with these drugs," said Joseph Finn, Special Agent in Charge for the Postal Service's Office of Inspector General. "Last year the Postal Service paid more than $1 billion in workers' compensation benefits to postal employees injured on the job."

"The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer's crimes," said Mike Loucks, acting U.S. Attorney for the District of Massachusetts. "Pfizer violated the law over an extensive time period. Furthermore, at the very same time Pfizer was in our office negotiating and resolving the allegations of criminal conduct by its then newly acquired subsidiary, Warner-Lambert, Pfizer was itself in its other operations violating those very same laws. Today's enormous fine demonstrates that such blatant and continued disregard of the law will not be tolerated."

These are such harsh words against Pfizer that you might think I wrote them. Yet they're printed word-for-word by the Dept. of Justice. Read them yourself here: http://www.usdoj.gov/opa/pr/2009/Se...

Do you see what all these statements have in common? Money is tight. Big Pharma's price fixing and marketing fraud was well tolerated when easy money was readily available, but now that the writing is on the wall with record government debt, falling tax revenues and huge budget cuts at the state level, every dollar counts. Suddenly Big Pharma's fraud looks like a lucrative target where some money can be recovered and restored to state coffers.

A tidal wave of legal action against drug companies?
I have a feeling these Pfizer fines are just the beginning. In an economy where unemployment is skyrocketing and state and federal budgets are getting squeezed, pharmaceutical companies look a little suspicious sitting on a big pile of cash. Where did all that cash come from? And why aren't the American people any healthier after spending all that cash on Big Pharma's medications?

Everybody in the law enforcement side of government already knows the pharmaceutical industry operates in blatant violation of the law. Now it's just a matter of figuring out what it will cost in legal fees to prove Big Pharma's crimes and recover yet more billions from companies like Pfizer. State administrators are running this formula through their heads right now: If we spend, say, ten million dollars on legal fees and investigative efforts against the drug companies, we stand a good chance of recovering a hundred million dollars (or more) in money that can go straight into the state treasury... and that means we don't have to shut down as many schools, or state parks, or social services, etc. in order to balance the state budget.

It's a tempting equation, especially during difficult economic times. And now that the DOJ has proven they can get a guilty plea and a few billion dollars out of just one pharmaceutical giant, the gold rush is on: More states (and perhaps more nations) will see this as a green light to go after the money.

What we're likely to see now with Big Pharma is a lot like what happened with Big Tobacco. The tobacco industry wasn't sued by states because it manufactured a product that killed people -- that sort of thing has always been tolerated in America -- it was sued because the states saw easy money combined with a great cover story. "We're saving people from tobacco!"

Now, there's a new cover story that we'll see repeated as the states go after Big Pharma: "We're saving our health care system!"

And it's largely true. Health care cannot financially survive if the biggest corporate players routinely engage in criminal fraud as a way of doing business.

That's why this DOJ settlement with Pfizer over the criminal marketing of its Bextra drug is a step in the right direction. While one criminal conviction won't end Big Pharma's fraudulent drug racket over night, it is at least a shot over the bow of pharmaceutical manufacturers, warning them that there are limits to the degree of deception in which they can engage.

As part of the settlement with the DOJ, by the way, Pfizer also agreed to an "expansive corporate integrity agreement" designed to root out and halt criminal behavior by its own employees in the future. It's fascinating that corporate ethics in America have sunk so low that a company must actually launch an internal corporate integrity program just to teach its employees and officers to avoid engaging in felony crimes.

Nigerians to sue US drug company over meningitis treatment

2009-10-24T14:24:00.000-07:00

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1172920/

Sep 15, 2001
Nigerians to sue US drug company over meningitis treatment
Carl Kovac

n what is reportedly the first such legal action in the United States, 30 families from Nigeria are suing the US based drug manufacturer Pfizer Pharmaceuticals in a federal court in New York for allegedly carrying out medical experiments on the children of foreign citizens without consent.

The move marks the latest development in a long saga about whether Pfizer used a new drug without official approval during a meningitis epidemic in Nigeria five years ago. An inquiry was set up by the Nigerian health minister, Tim Menakaya, in January this year into the allegations (BMJ 2001;322:194).

According to the suit, during a meningitis epidemic in 1996 Pfizer treated 100 children at the Infectious Diseases Hospital in Kano, Nigeria, with its antibiotic trovafloxacin (Trovan) as part of an effort to determine if the drug would be effective against bacterial meningitis.

Members of the company's research team gave another 100 children ceftriaxone—an accepted drug for meningitis—but in lower than recommended doses. Eleven of the children died, and others developed brain damage, partial paralysis, or deafness, the suit said.

The suit alleges that "Pfizer took the opportunity presented by the chaos . . . in Kano to accomplish what the company could not do elsewhere; to quickly conduct on young children a test of the potentially dangerous antibiotic Trovan."

It continues: "Pfizer chose to select children to participate in a medical experiment of a new, untested and unproven drug without first obtaining their informed consent, or explaining to the children or their parents that the proposed treatment was experimental and that they were free to refuse it and instead choose the safe, effective treatment for bacterial meningitis offered at the same site, free of charge, by a charitable medical group."

The relief organisation, Médecins Sans Frontières, was already providing free treatment at the hospital with the antibiotic chloramphenicol, an internationally accepted treatment for bacterial meningitis, the suit pointed out.

The Nuremberg Code of 1947 and the World Medical Association's Declaration of Helsinki stipulate that researchers seeking to conduct medical tests on humans must explain the purpose of the tests, the methods to be used, and the risks involved and must obtain their subjects' voluntary consent.

The suit notes that Dr Juan Walterspeil, an specialist in infectious diseases who was assigned to the test, repeatedly warned Pfizer that it was violating international laws, federal regulations, and medical ethics. Dr Walterspeil was subsequently fired.

A spokesman for Pfizer Limited said: "The Trovan study in Kano, Nigeria, was an important clinical investigation, and Pfizer is proud of the way the study was conducted, in the midst of a deadly meningococcal meningitis epidemic in Nigeria. The study was well conceived, well executed and saved lives.

"The study was conducted with approval of the Nigeria federal and state governments and with consent from the families of treated patients.

"The study was part of a broad series of studies of Trovan for the treatment of many serious infections. Results showed that Trovan was as effective as ceftriaxone, proven to be a highly effective treatment for meningococcal meningitis.

"Fatality rates in the Kano study, approximately 6% for both Trovan and ceftriaxone, were lower than published results for other forms of treatment in this epidemic."

Pfizer accused of testing new drug without ethical approval

2009-10-24T14:21:00.000-07:00

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1119465/

Copyright © 2001, BMJ
Pfizer accused of testing new drug without ethical approval
Jacqui Wise

An official inquiry has been set up into allegations that the drug manufacturer Pfizer did not obtain official approval before testing a new drug on children during a meningitis epidemic in Nigeria five years ago.

The Nigerian doctor who supervised the clinical trial has said that his office backdated an approval letter and this may have been written a year after the study had taken place.

Pfizer, whose headquarters are in New York city, has admitted that the local ethics approval given to conduct the trial may not have been properly documented: “Pfizer takes this issue very seriously and is fully cooperating with the Nigerian authorities.”

In 1996 Pfizer sent a team to Kano in the north of Nigeria during an epidemic of meningococcal meningitis. To test the efficacy of its new antibiotic trovafloxacin (Trovan) they carried out an open label trial in 200 children, half of whom were given trovafloxacin and half the gold standard treatment for meningitis, ceftriaxone. Five of the children given trovafloxacin died, together with six who were given ceftriaxone. Pfizer said that 15000 people died during the epidemic.

The Washington Post has been investigating the trial and alleges that at least one child was not taken off the experimental drug and given the standard drug when it was clear that her condition was not improving—which is against ethical guidelines.

The newspaper also claims that Nigerian patients were not warned that animal studies had shown that drugs similar to trovafloxacin may cause joint damage, whereas US patients were told of the research in a subsequent trovafloxacin trial. The drug's licence was withdrawn in Europe because of liver toxicity and some deaths.

The letter granting ethical approval for the Pfizer trial was submitted to the US Food and Drug Administration in 1997 to support a licence application for trovafloxacin. However, Sadiq Wali, the medical director of the Aminu Kano Teaching Hospital, told the Washington Post that the letter was false and the hospital had no ethics committee at the time of the study.

Abdulhamid Isa Dutse, the doctor who oversaw the trial at the hospital, told the newspaper that it was “possible” that the approval letter was drafted up to a year after the trial.

The Nigerian health minister, Tim Menakaya, has now appointed a federal investigative panel to determine whether the trial was conducted legally and if so whether it was morally right.

The investigation has generated a lot of publicity in the Nigerian press. The newspaper Vanguard said: “The government has a duty to tell us whether our children were used as guinea pigs and, if so, who committed such criminality and who is liable.”

Charles Medawar, director of Social Audit, the UK pressure group that monitors the pharmaceutical industry, said: “This particular case looks to be very bad, but I hardly think it is untypical.”

Family sues drug firms, doctors over suicide

2009-10-23T05:53:00.000-07:00

http://www.omaha.com/index.php?u_np=0&u_pg=1642&u_sid=1222761

October 6, 2004
Family sues drug firms, doctors over suicide
BY KEVIN COLE
WORLD-HERALD STAFF WRITER

An Omaha family filed a lawsuit Tuesday in Douglas County District Court alleging negligence by two drug companies and three health-care professionals in the death of their 11-year-old son.

David and Debra Jackson contend that the Oct. 10, 2002, suicide of their son, Jacob, was the result of side effects from the antidepressant drugs Zoloft and Effexor.

Spokeswomen for Children's Hospital and Immanuel Medical Center declined to comment. Calls seeking comment from Pfizer Inc. and Wyeth Pharmaceuticals Inc. were not immediately returned.

On Sept. 14, the FDA's medical advisory group decided that antidepressants should come with a "black box warning" that they can "spur suicidal behavior in children and teenagers."

The lawsuit alleges that Pfizer Inc. "failed to adequately test, evaluate and otherwise study the pediatric effects of Zoloft before marketing it to the public."

Also named as defendants are Sharon S. Cannon, Ph.D., and Dr. Michelle M. Cassidy of Children's Hospital; and Dr. Michael L. Coy of Alegent Health-Immanuel Medical Center.

The lawsuit alleges that none of the defendants warned that "Jacob should be watched closely for signs that his condition was getting worse."

Jacob, according to the lawsuit filed by attorney Andrew J. Hilger, was being treated for depression following the deaths of a neighborhood friend and his grandfather.

The lawsuit states that Jacob began taking Zoloft on Sept. 9, 2002, on the recommendation of Cannon.

The lawsuit alleges that after Jacob began taking the medication "his behavior and symptoms worsened to include intensified agitation, suicidal desires, hysterical behavior, irritability, hostility, mania, restlessness, decreased ability to control impulses and chronic refusal to go to school."

The lawsuit states that Jacob's Zoloft dosage was increased three times between Sept. 17 and Oct. 2 on the recommendations of Cannon, Dr. Cassidy and Dr. Coy.

Then "on or about Oct. 8," Dr. Cassidy advised the gradual decrease of the Zoloft dosage and prescribed the drug Effexor.

Two days later, Jacob was found dead in his parents' basement, having hanged himself.

Probe into anti-depressants being conducted 'in secret'

2009-10-23T05:52:00.001-07:00

http://www.theaustralian.news.com.au/story/0,25197,24584116-23289,00.html

Probe into anti-depressants being conducted 'in secret'
Julie-Anne Davies | November 01, 2008

THE Therapeutic Goods Administration is investigating the adverse effects of SSRI anti-depressants, a widely prescribed group of drugs that includes the well-known brands Prozac and Zoloft.

The TGA confirmed in a statement to The Weekend Australian that it had established a special expert panel of psychiatrists and epidemiologists to review a number of cases involving patients who had had adverse reactions to these drugs. It is believed hundreds of cases will be reviewed.

"Although there has not been a jump in adverse events from SSRIs, there has been community concern about potential overuse," the TGA said.

Medicare figures show that, since 1990, when Prozac first appeared on pharmacy shelves, there have been almost 10,000 reports of suspected adverse reactions to SSRIs received by the TGA's Australian Adverse Drug Reactions Advisory Committee.

More than 12 million SSRI antidepressant scripts were subsidised by the Pharmaceutical Benefits Scheme last year.

Sydney psychiatrist Yolande Lucire, who has reported between 300 and 400 cases to the TGA in which she claims patients have had serious reactions to the anti-depressants, including some who had committed suicide, said the inquiry must be made public.

"This is being done in secret," Dr Lucire said. "We have no terms of reference, no opportunity for people to make submissions; it's a scandal."

Federal Health Department secretary Jane Halton wrote to Dr Lucire recently, informing her the inquiry was under way and the panel would report back at the end of this year.

"This only happened after," Dr Lucire said. "In frustration at being fobbed off by the TGA, I personally sent the head of the department 100 cases detailing what had actually happened to people who went from being fully functioning members of the community to patients with serious mental health problems and some who in fact killed themselves after being put on these drugs for stress-related disorders."

The TGA has also asked all drug companies that market SSRI anti-depressants in Australia to update the wording of their suicide warnings concerning children and young people under 24 years in the information provided to patients.

"The TGA is working with other sponsors to ensure that the wording in the CMIs clearly reflects the issues contained in the product information for their products," it said.

The move comes after an investigation by The Weekend Australian revealed several hundred thousand scripts for anti-depressants such as Zoloft and Prozac were last year prescribed to children and subsidised through the Pharmaceutical Benefits Scheme, despite the TGA and Pfizer, the company that markets Zoloft in Australia, recommending they not be prescribed to anyone under the age of 24 for the treatment of depression.

Significant discrepancies in the information given to parents about the potential dangers of the drugs to children were also uncovered.

Two weeks ago, Melbourne mother Nicola Mulcahey reached a confidential court settlement with her 16-year-old daughter's GP, who she had sued for prescribing Zoloft to the teenager for depression.

Ms Mulcahey claimed the drug made her daughter suicidal and said she was not advised of the risks associated with the drug.

In another case detailed in The Australian and now being followed up by Pfizer, a 14-year-old girl became suicidal after taking Zoloft. Her parents said they were not warned this might happen nor told to monitor her for symptoms of suicidal thoughts or self-harm.

David Kitching, from the Royal Australian and New Zealand College of Psychiatrists, said his organisation was unaware of the inquiry and had not been approached by the TGA to contribute.

"But in the general setting I would say that nothing new in the literature suggests we need to be any more vigilant than we already have been when it comes to documenting the side effects of this class of drug," Dr Kitching said.

Convicted killer sues Pfizer for millions

2009-10-23T05:46:00.000-07:00

http://journalstar.com/news/local/article_f582e12e-75fc-5ed5-a722-554b64cb1ffd.html

A CONVICTED MURDERER WHO STRANGLED THE TEENAGE MOTHER OF HIS CHILD HAS SUED PFIZER, ALLEGING THE ZOLOFT HE WAS TAKING LED HIM TO TRY TO COMMIT SUICIDE AND THEN TAKE HIS GIRLFRIEND'S LIFE.
LORI PILGER / Lincoln Journal Star
Posted: Friday, June 26, 2009

A convicted murderer who strangled the teenage mother of his child has sued Pfizer, alleging the Zoloft he was taking led him to try to commit suicide and then take his girlfriend's life.

Randall Robbins II wants $1 million from the maker of the antidepressant and the Lincoln doctor who prescribed it to him for every year he spends in prison.

He was 17 when he killed Brittany Eurek in 2002.

But, if the now 25-year-old wants to pursue the suit, he'll need to find an attorney to take it on or do it himself.

Lancaster County District Judge Jeffre Cheuvront rejected a request from Robbins to appoint an attorney to represent him and to let him file the case without paying the fees and costs.

If Robbins doesn't come up with $79 or appeal the ruling within 30 days, the case will be dismissed.

In the suit filed Tuesday, he said Pfizer failed to warn him of side effects of Zoloft.

"Pfizer knew or should have known the effects, including that R.R. might commit or attempt suicide and murder…," he said.
Robbins said the drug intensified his agitation, suicidal desires and irritability and decreased his ability to control impulses.
He seeks $2 million each from Pfizer and his doctor for emotional distress and physical pain suffered. He also wants $1 million from each of them for each year he's spent incarcerated and away from his family.

Robbins argues that Pfizer and his Lincoln doctor both were negligent.

At 10:49 on the night of June 1, 2002, Robbins' mother called 911, saying her son had summoned her. When she got home, she said, she found Brittany Eurek in Randall Robbins' bedroom, not breathing and with red marks on her neck.

Police arrived at the Euclid Avenue duplex he and his mother and sister shared to find Robbins crying with a cloth over his head, saying, "arrest me, arrest me."

They found Eurek on his bedroom floor. She was pronounced dead at the hospital, despite attempts to revive her.

In court records, Robbins said his doctor prescribed Zoloft for depression earlier in the year. He said his symptoms worsened and he attempted suicide by hanging himself with a belt. Then, on June 1, he held Eurek's neck until she passed out and used the same belt to assure she was dead, the records say.

The Food and Drug Administration now advises parents that such antidepressants as Zoloft can increase suicidal thoughts and actions in some children and teens, according to its Web site.

But, the FDA says, suicidal thoughts and actions also can be caused by the depression such drugs are used to treat.

It says nothing about the drugs causing an increase in homicidal thoughts.

When asked to comment, Chris Loder in media relations at Pfizer Inc. defended Zoloft in an e-mail Friday, calling it a safe and effective medication that has been used to treat millions with depression and anxiety disorders.

And, he said, the label fully complies with all FDA-mandated requirements, including information on adverse events.

"We continuously monitor the postmarketing safety of our medicines and evaluate all available data to ascertain any signal of increased risk. Pfizer's evaluation of Zoloft data never has revealed any signal of an increased risk of violence related to either use or discontinuation of use of Zoloft."

Robbins is serving a 40- to 60-year sentence at the Nebraska State Penitentiary after pleading guilty to second-degree murder.

He will be eligible for parole in 2022.

Reach Lori Pilger at 473-7237 or lpilger@journalstar.com.

Pfizer Pharmaceuticals being charged with murder

2009-10-23T05:43:00.000-07:00

http://weeksmd.com/?p=644

Pfizer Pharmaceuticals being charged with murder
Posted By Brad Weeks, MD On March 14, 2008

Obviously some countries do not put up with the atrocities we have come to accept as commonplace! Although it has taken them some time to get this into court, Africa is going after Pfizer for the deaths and damage produced during or as a result of
their drug trials conducted in 1996 on African citizens.

The accused face 65-charge counts of criminal conspiracy, causing grievous harm and culpable homicide.

The Kano state government filed civil and criminal suits demanding 2.75 billion dollars (two billion euros) in compensation from Pfizer and prosecution of its staff involved in testing Trovan during a triple epidemic of measles, cholera and meningitis in which over 12,000 people died.

The drug test allegedly led to 11 deaths and deformities in 189 other cases such as blindness, deafness, brain damage and paralysis.

And how many more deaths do we have in this country from Pfizer’s drugs? Have you checked out all the new articles on our database of cases at www.ssristories.com_ (http://www.ssristories.com) yet? Go there and do a search according to date and see all the new cases added just in the last six months, not just for Pfizer drugs, but all of them.

Ann Blake Tracy, Ph.D., Executive Director,
International Coalition For Drug Awareness

Bextra: The Kind of Pain That Never Leaves You

2009-10-23T05:39:00.000-07:00

http://www.lawyersandsettlements.com/features/bextra-wife-died.html

Bextra: The Kind of Pain That Never Leaves You
April 1, 2008. By Gordon Gibb

San Francisco, CA: Joann Simmons is a name on a court docket now—just two words in a legal document. But those two words represent someone's life partner, who is no longer here. And the life partner left behind, James Simmons, has filed a wrongful death suit against the makers of Bextra.

Bextra, a pain medication manufactured by Pfizer, is off the market now after the US Food and Drug Administration (FDA) asked Pfizer to voluntarily take the drug off the market in April of 2005. However, three years later and probably for many years to come, various lawsuits are expected to percolate through the courts as individuals, or the families of those individuals allegedly harmed at the hands of Bextra, seek their day in court.

The Simmons lawsuit was filed February 6th of this year in Southern California District Court. In addition to the wrongful death claim, Pfizer Pharmacia is facing allegations of negligence, strict liability, breach of express and implied warranty, fraudulent misrepresentation and concealment, and unjust enrichment.

Bextra was a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed for arthritis, and worked by blocking the body's production of pain transmission enzymes known as cyclo-oxygenase, or COX.

Of the two forms of COX enzymes, COX-2 appears to have been associated with more elevated risks when attempts are made to block them. For example, well-known COX-1 inhibitors such as ibuprofen, Aspirin and Aleve are widely used, and not known for high risks or dangerous adverse affects.

However, the same cannot be said for COX-2 inhibitors, a class of medication to which Bextra belonged. Another well-known COX-2 NSAID, Vioxx, came to be vilified and was eventually pulled from the market by manufacturer Merck and Co. after studies showed increased cardiovascular risk.

However, Pfizer opted to continue with Bextra and a companion COX-2 selective inhibitor Celebrex, in spite of the warning signs. The company noted in its 2004 year-end review that preliminary results from a study being conducted under the auspices of the National Cancer Institute showed an increased risk in overall cardiovascular events. Pfizer noted that the findings were at odds with data collected from a number of other well-controlled studies of Celebrex.

Pfizer went on to state in its annual review, posted online, that a committee of the European Medicines Evaluation Agency, together with a special FDA Advisory Committee, conducted thorough reviews of all COX-2 medicines and concluded they should remain on the market, albeit with more stringent labeling that highlighted the cardiovascular risk.

Celebrex remains on the market, and does indeed carry warnings of heightened risk to the heart. However, by the start of the second quarter of 2005, Pfizer had to face the removal of Bextra from the market, a drug which, according to the review, was worth $1.29 billion in sales to the company and grew 87 percent in spite of growing concern with regard to the drug through 2004 over cardiovascular risk and rare, but serious skin reactions. It has been reported that the latter amounted to the primary reason why Bextra was pulled.

So Bextra is gone. But that's cold comfort for James Simmons, whose wife died allegedly at the hands of Bextra. And there are others—including a lawsuit launched back in the fall of 2004 after a New Jersey man died at the age of 46, after taking Bextra for nine months.

Lives lost, all for the seemingly innocent act of popping an approved pill for pain.

It is alleged that Pfizer withheld increased risks for fear that consumers would eschew purchasing Bextra, in preference to less-expensive drugs.

Bextra - Recalled for Heart Attack Risk

2009-10-23T05:35:00.000-07:00

http://www.lawyersandsettlements.com/case/bextra.html?ref=article10183

Bextra - Recalled for Heart Attack Risk

On Apr-07-05 the FDA asked Pfizer, the manufacturer of Bextra, to recall the pain medication from shelves across the U.S. due to risks of heart attacks and strokes in patients. Canada Health quickly followed suit and asked Pfizer to recall Bextra from Canadian shelves. Pfizer has also suspended sales of Bextra in the European Union.

Bextra has been prescribed to arthritis sufferers to relieve symptoms of osteoarthritis and rheumatoid arthritis. Bextra has also been prescribed to women in hopes of relieving PMS and painful menstrual cycles. Bextra is classified as a Cox-2 inhibitor, a newly developed drug in the Non-Steroidal Anti-Inflammatory (NSAID) family. To date, several Cox-2 inhibitors have been banned due to the increased risk of stroke, heart attack, stomach ulcers, liver damage, and severe skin reactions.

On Jan-29-05, health care giant Kaiser Permanente, an HMO serving 2.6 million Californians, stopped prescribing Bextra to its patients.

"This is not a drug that saves lives,'' said Dr. Sharon Levine, a pediatrician who oversees medication usage for Kaiser Permanente's Northern California division. "It's a drug that provides a modest degree of pain relief -- no better than Motrin -- and the size of the risk, given the benefit provided, did not seem warranted.''

On Dec-10-04 the FDA increased the warning on Bextra labels to include a "black box" warning against using the medication for patients with cardiac problems.

On Nov-11-04, University of Pennsylvania researchers told the American Heart Association that a recent clinical trial revealed that patients taking Bextra had more than twice the incidence of heart attack and stroke than nonusers.

On Oct-18-04, Pfizer admitted that two small clinical trials showed heart bypass surgery patients taking Bextra had a higher risk of stroke and heart attack.

University of Pennsylvania pharmacologist Dr. Garret FitzGerald claims "The magnitude of [cardiac problems] with Bextra is even higher than what we saw in Vioxx." Bextra's risk appeared to pose a slightly higher risk than Vioxx for heart attack and stroke. FitzGerald believes that the same mechanism that makes the Cox-2 inhibitor drugs easier on the stomach also blocks a substance that prevents heart problems.

Bextra Articles

Bextra: The Kind of Pain That Never Leaves You
Joann Simmons is a name on a court docket now "just two words in a legal document. But those two words represent someone's life partner, who is no longer here. And the life partner left behind, James Simmons, has filed a wrongful death suit against the makers of Bextra.

Vioxx/Bextra: "They get you fixed but then they stonewall you."
Jay Sullivan is a cancer survivor, which is an accomplishment in itself. He's also a survivor of Merck's Vioxx and Pfizer's Bextra, two nonsteroidal anti-inflammatory drugs (NSAIDS) that were pulled from the market because of a dangerously high risk of heart attack.

Bextra, Bextra! Read All About It! First trial to be heard in May
Nearly four years after Bextra was taken off the market for cardiovascular risk, the first Bextra trial is scheduled to be heard May 5th. On the heels of the mammoth $4.85 billion Vioxx settlement, the Multi-District Litigation (MDL) Court for the Bextra/Celebrex litigation is finally ramping up in California.

Bextra in the News

OCT-05-05: Bextra lawsuit filed in U.S. District court - East St. Louis on behalf of seven plaintiffs; five plaintiffs allegedly suffered strokes and heart attacks after taking the prescription pain reliever and two plaintiffs are filing complaints after their family member died due to cardiovascular problems allegedly associated with Bextra. The lawsuit seeks damages against Pfizer, Pharmacia, Monsanto and Searle with claims that the companies did not disclose proper warnings regarding Bextra's side effects and failed to adequately test Bextra prior to distribution. Monsanto and Searle merged with Pharmacia in 2000 and Pfizer and Pharmacia merged in 2003. [THE RECORD: BEXTRA]

APR-07-05: The FDA pulls Bextra off the market and issues a Public Health Advisory to patients using Cox-2 inhibitors Bextra and Celebrex warning of side effects and risks of cardiovascular (CV) events and gastrointestinal (GI) bleeding. [FDA: BEXTRA]

Bextra Lawyer

If you or a loved one has suffered from the side effects of Bextra, you may qualify for damages or remedies that may be awarded in a possible lawsuit. Find a Bextra Lawyer. Please click the link below to submit your complaint to a lawyer who will review your claim at no cost or obligation.

Please click here for a free evaluation of your case

Bextra: "They Got Away with Murder"

2009-10-23T05:28:00.000-07:00

http://www.lawyersandsettlements.com/articles/10183/bextra-stroke-death.html

Bextra: "They Got Away with Murder"
March 15, 2008. By Jane Mundy

Atlanta, GA: "I was told that if my mother had lived--as a vegetable in a hospital bed-- there would be a lawsuit, but because she died, there was no recourse," says Dianne Nev. "Pfizer, the maker of Bextra, can't make you a vegetable and get away with it, but they can get away with murder."

"My mother started taking Bextra in May, 2002 after a knee injury; she developed rheumatoid arthritis," says Nev. "And she continued to take it until she had a stroke in December; she took Bextra every day for six months.

There was no inkling of anything wrong with Nev's mother. Other than arthritis, Nev's mother was healthy; the day before her stroke, she did water aerobics. "She had a headache that morning—she lived with me," says Nev. "I was working in our basement when mother told me she was feeling better and decided to go to the store--that was the last time I saw her. 'I'm going to the store now, I love you,' she said. And that was it."

Apparently she opened the grocery store door and said, ' I think I am having a stroke, somebody please call 911'. By the time I got to the hospital, she was already brain-dead.

She had a stroke and it had traveled through her brain. The doctors told me that if she lived she would be a vegetable. I told them to pull the plug: mother had made a living will saying she never wanted to be kept alive on life support.

My mother was 76 when she passed away, right before Christmas. She bought me a statue of a little girl kissing a snowman and it was titled 'I'm going to miss you.' How eerie is that?

When Vioxx and Bextra were taken off the market, you only really heard about Vioxx, but essentially they were the same drug. About one year after my mother died, I found out that people were involved in a class action suit from taking Bextra. Exactly the same thing happened to them, except they were still alive.

I believe that Pfizer knew the side effects of Bextra before it was ever put on the market and didn't warn anyone. Every day I think about her and it still bothers me. It was her birthday last week and I put flowers in front of her picture.

Even though she was 76 and lived a long life, it isn't right that she died because of this drug. I wish drug companies would be as conscientious about what they give people; would they give Bextra to their mothers? I doubt it."

Pfizer conducted two studies that showed heart bypass surgery patients taking Bextra had a higher risk of stroke and heart attack. Bextra is an anti-inflammatory and in the same class of COX-2 inhibitors as Vioxx. The U.S. Food and Drug Administration asked Pfizer to withdraw Bextra (valdecoxib) from the market on April 7, 2005.

Bextra was only studied in arthritis patients for up to one year before it was prescribed to patients like Dianne Nev's mother.

Pfizer Murder Suspects Pay to Have Criminal Charges Dropped

2009-10-23T05:19:00.000-07:00

http://watchdogonscience.blogspot.com/2009/07/pfizer-murder-suspects-pay-to-have.html

FRIDAY, JULY 31, 2009
Pfizer Murder Suspects Pay to Have Criminal Charges Dropped

Someone once said...yes...we live by the Golden Rule...."those with the gold, make the rules." Unfortunately, this is the case with Pfizer, the largest and wealthiest pharmaceuitical company in the world. In a story from the Washington Post, ten Pfizer executives and scientists avoid criminal charges for allegations of murdering African children by offering a "Pfizer Pot of Gold".

In 1996 Pfizer had instituted an illegal clinical trial in Nigeria using a dangerous drug called Trovan. Even when Pfizer in-house physician, Dr. Juan Walterspeil, had warned the Pfizer CEO that the trial was unethical, Pfizer terminated Walterspeil and moved ahead with the trial, resulting in many children permanently disabled and 11 children dead.

What was the price Pfizer paid to avoid sending the culprits to jail? $75 million.

Pfizer settles big health care fraud case: $2.3 billion settlement is largest of its kind

2009-10-23T05:15:00.000-07:00

http://www.allbusiness.com/government/government-bodies-offices/12815830-1.html

By Guy Boulton
Publication: The Milwaukee Journal Sentinel (Wisconsin)
Date: Thursday, September 3 2009

Sep. 3--The Justice Department on Wednesday announced the largest health care fraud settlement in its history, in which American pharmaceutical giant Pfizer Inc. has agreed to pay $2.3 billion for fraudulent marketing and a wide array of other potentially illegal acts.

The landmark settlement was announced at a news conference at Justice Department headquarters and reflects a renewed emphasis by the Obama administration on holding U.S. corporations accountable for their activities, Justice Department officials said. Wisconsin will receive $5 million as its share of the $2.3 billion, Attorney General J.B. Van Hollen said.

The agreement stemmed from allegations that Pfizer improperly promoted drugs and paid kickbacks.

Pfizer, the world's largest drug company, will pay the states and the federal government a total of $1 billion in civil damages and penalties to compensate Medicaid, Medicare and various federal health care programs.

A Pfizer subsidiary, Pharmacia & Upjohn Co. Inc., also agreed to plead guilty to a felony violation and to pay a criminal fine and forfeiture of $1.3 billion, according to the news release from the Wisconsin Department of Justice.

The criminal complaint stemmed from the illegal marketing and promotion of Bextra, an anti-inflammatory drug that Pfizer pulled from the market in 2005.

The settlement is based on nine cases that were filed in U.S. District Court for the District of Massachusetts, U.S. District Court for the Eastern District of Pennsylvania and U.S. District Court for the Eastern District of Kentucky by private individuals under state and federal false claims statutes.

Wisconsin was a co-plaintiff in five of those actions.

The lawsuits alleged that Pfizer promoted multiple drugs for uses not approved by the Food and Drug Administration. Pfizer also is alleged to have paid kickbacks, in the form of entertainment, cash, travel and meals, to doctors and other health care professionals to induce them to promote and prescribe Bextra, Geodon, Lyrica, Zyvox, Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec.

"Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers and costs the government billions of dollars," said Tony West, assistant attorney general for the Civil Division. "This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare."

Kathleen Sebelius, secretary of Department of Health and Human Services, hailed the settlement and said her agency "will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it."

"But we will also look for new ways to prevent fraud before it happens," Sebelius said. "Health care is too important to let a single dollar go to waste."

Pfizer officials could not be reached immediately for comment.

But as part of the settlement, the company has agreed to enter into an expansive corporate integrity agreement with the Health and Human Services Office of Inspector General, under which it will put in place special procedures and reviews "to avoid and promptly detect conduct similar to that which gave rise to this matter," the Justice Department said in a statement

Pfizer Plays Around with Lives?

2009-10-23T05:12:00.000-07:00

http://ayushveda.com/blogs/business/corporate-social-irresponsibility-pfizer-plays-around-with-lives/

Corporate Social (Ir)responsibility – Pfizer Plays Around with Lives?
By krish on October 08th, 2009

When you think of large organisations spawning the globe with a brand that has grown larger than life, you may be excused for thinking of them as powerful entities that have grown their size with a commitment to quality and customer service. Well, that’s supposed to be the case, at least in theory. As any one with a bit of worldly experience would vouch for, theory falls short of the ground realities and risks to society, associated with corporate behemoths, sometimes, far outweigh what is illustrated in text books.

Consider our favorite drug maker, Pfizer Inc. A multi-national with operations across continents, Pfizer just became bigger with its deal with Wyeth Pharmaceuticals, which made it the world leader in cardiovascular treatment and Primary Care. The combined entity would enjoy revenues of $70 billion.

Granted, companies just don’t get to “enjoy” revenue and wealth – they fight for it, they sweat it out. And they become powerful. That’s precisely why there is so much social responsibility expected of the big guys with muscle power. And that’s precisely why it is utterly disappointing to see these money machines display arrogance and total disregard to the very consumers whom they pledge to serve all out.

The latest instance is where Pfizer faces a law suit from a consumer who has used its cholesterol lowering drug, Lipitor, which is famous and is widely prescribed around the world. The complaint alleges that Pfizer failed to bring to the notice of users that the cholesterol lowering drug also had side effects such as nervous problems, which in the case of the complainant, Michael Mazaariello, arose three years after he had stopped using the drug. He alleges that Pfizer did not caution users or the medical community of the possible side effects, projecting Lipitor as a safe drug.

This is not the first of such cases – very recently, Pfizer was forced to pay a hefty compensation of $2.3 billion when a whistle-blower blew it long and hard, fighting it out in the courts of law for four years for alleged malpractices within Pfizer, and for promoting its drug Bextra for unapproved uses and dosages. Pfizer had shelled out another $430 million in settling similar law suit in 2004 on felony charges, where it pleaded guilty of promoting its drug Neurontin for many uses unapproved by the FDA.

Settling huge amounts on law suits and carrying on with its business as usual may sound all to cool for a behemoth as big as Pfizer Inc. But it needs to realise that it is in the serious business of dealing with human health and that it operates in the society that it has come to affect adversely these days. And as Newton concluded, Pfizer may have to deal with the reactions for its actions, if it doesn’t do a brand make over and place its priorities right.

Pfizer Loses Lawsuit over Database

2009-10-23T05:09:00.000-07:00

http://pharmtech.findpharma.com/pharmtech/News/Pfizer-Loses-Lawsuit-over-Database/ArticleStandard/Article/detail/574229

January 8, 2009
Pfizer Loses Lawsuit over Database
By Erik Greb

San Francisco (Dec. 24)—A California jury ordered Pfizer (New York) to pay $38 million to the Ischemia Research and Education Foundation (IREF), a medical-research nonprofit group, for stealing trade secrets to develop its “Bextra” analgesic. A Santa Clara County Superior Court jury reached the verdict on Dec. 22, 2008, according to an Associated Press (AP) WorldStream story.

IREF filed the lawsuit against Pfizer in 2004. The suit alleged that Pfizer wanted to use IREF’s database in 2002 for clinical trials of the Bextra treatment for acute arthritis pain. Pfizer and the foundation could not agree on terms for use of the database, and IREF claimed that the company struck a deal with Ping Hsu, a lead statistician at IREF. Hsu provided the data without approval, according to AP.

Jeffrey Frenster, the jury foreman, told The San Jose Mercury News that a great deal of evidence persuaded jurors that Pfizer had improperly obtained much medical research that had taken decades to develop. Jurors concluded that Pfizer had conspired with Hsu to use the data without paying tens of millions of dollars through a contract. IREF also asserted that Pfizer and Hsu destroyed evidence when confronted about the data theft, according to The San Jose Mercury News.

Mark Geragos, one of IREF’s lawyers, said Pfizer and Hsu could face punitive damages that would increase the penalty to more than $120 million, according to AP. Attorneys in the case are expected to appear for post-trial motions before Judge Gregory Ward on Jan. 16, 2009. Ward will decide whether to assess more damages.

Dennis Mangano, head of IREF, said that spending $15 million in legal fees instead of accepting a financial settlement was worth it, according to AP.

Pfizer said it would appeal the decision. “The company stands by the belief that its conduct was proper,” the company said in a written statement. “Pfizer continues to believe that it was unjustly caught in a crossfire between [the foundation] and one of its former employees.”

In April 2005, Pfizer pulled Bextra off the market at the request of the US Food and Drug Administration because of concerns that it posed a heart risk.

Rimadyl: News, Views & Advisories

2009-10-19T12:54:00.000-07:00

http://www.srdogs.com/Pages/rimadylfr.html

Rimadyl: News, Views & Advisories

Summer 2009 -- Reports of Adverse Reactions Continue, No Warnings Given by Veterinarians......Ten Years Later!!!

Even though the FDA mandated revised labeling for Rimadyl and the distribution of a "Client Information Sheet" when Rimadyl is dispensed, problems continue with this drug. We discontinued the regular posting on this website of adverse events due to Rimadyl quite some time ago, but, in the past few days several new cases appeared in the space of 48 hours. Is this just coincidence, or is something going on here? If, after reading these latest case histories, you're concerned about your dog's possible adverse reaction to Rimadyl, please follow these guidelines.

From Roni Goldberg, Fort Lauderdale, FL, August 14, 2009:

"My beautiful Yorkie, Katy, was 13 years old when I noticed she seemed to be having problems with an imbalance when she walked. I took her into my vet and he said that, due to her age, it was probably arthritis. He didn't give her much of a check-up, but just walked out of the examining room and came back in and gave her a shot. He didn't describe why he was doing it or what it was. He mentioned that he would be prescribing medication for her that would help her, but again, didn't tell me what the medication would be. When I went to check out and they gave me the bill, I saw that the shot was Rimadyl and the medication he had prescribed was Rimadyl. I told the nurse he didn't tell me he was giving her a shot of Rimadyl. He argued with me and then said he would take it off my bill. I told him that wasn't the point. I thought I should have been informed about the treatment prior to its being administered. However, I also felt that, if the veterinarian thought it would help her, I would give Katy the Rimadyl and see whether, in fact, it did.

"After a few days of giving Katy the Rimadyl pills, she couldn't walk at all, her stomach was distended, and her breathing was very heavy. I had three other veterinarians look at her -- all of whom said it wasn't a Rimadyl reaction, but thought that it might be cancer -- a tumor on her spine, perhaps. Finally, I took her to a veterinarian who did an X-ray and CBC (complete blood count). The CBC showed high levels of CREA, BUN, ALT, ALK -- all signs of Rimadyl toxicity. In an adverse reaction to Rimadyl, you are most likely to see: 1) low red blood cells, 2) high white blood cells, 3) elevated creatinine and BUN indicating kidney damage, and 4) elevated AST, ALT, ALK. The veterinarian said the X-ray showed no tumor on her spine and sent us home with a prescription for prednisolone. When I found out that prednisolone should not be given without a rest period of a week or more after administration of Rimadyl, I called the veterinarian's office to point this out. They would not allow me to return the medication. I had asked for help from Pfizer, as well as from all these veterinarians, and no one came through for my beautiful little Katy. I lost her on June 25, 2009. My heart is forever broken." Roni Goldberg has established a site in memory of Katy where people can report on and discuss their experiences with the adverse effects of Rimadyl.

From Jo Rakowski, August 11, 2009:

Jo's Yorkie, Schnurek, 9 years and 7 months old, had been hospitalized in the Animal Emergency Referral Center, Northbrook, Il, over the preceding weekend. He had taken Rimadyl for nearly three days and almost died. The veterinarian attending to Schnurek wrote: "Diagnosis: Gastroenteritis -- secondary to Rimadyl use vs other cause." Ms. Rakowski writes, "The same day I received the hospital diagnosis about the drug's adverse effect, I contacted Pfizer and reported this case; I also have the form from the FDA website to fax in to the agency. Thank goodness Schnurek recovered from Rimadyl and he enjoys life as always with his two Yorkie-brothers, Linka (7 years) and Guzik (2 years, 7 months)."

From Chris (last name and location withheld due to privacy and legal issues), August 12, 2009:

"Unfortunately, we took our Golden in for knee surgery and they NEVER gave us any warning info for the Rimadyl they put her on. She went into acute liver failure and fought for six weeks before finally losing her battle on July 26, 2009. "We did everything right in trying to be a good advocate for our poor puppy but the vet was negligent in not giving us the info as mandated by law. So now I have to sue my vet and maybe Pfizer, too. As soon as it was determined that Rimadyl was the cause of her condition, Pfizer offered us $1000, which I saw as blood money since that's what they paid on average to the plaintiff's in the class action suit. I sent the check back! I spent $25,000 trying to save her, and she fought so hard and all the doctors thought she might make it but even Pfizer had no data on any dog that was that sick that lived for more then a few days with her off-the-chart liver function numbers. I feel like I poisoned her and will carry that guilt forever."

From Pam (last name and location withheld due to privacy and legal issues), August 12, 2009:

"My dog, Nikki, just died last night and it appears it may have been related to a Rimadyl reaction. She was a very happy, high energy Australian Shepherd that I got from the local animal shelter seven years ago. She recently had her teeth cleaned and had a tooth pulled. At that time, they gave her an injection of Rimadyl and sent seven 100mg tablets home for me to give her ½ twice a day. I thought it was antibiotics that they sent home with me, and noticed three dats after her dental work that it was Rimadyl. I went online for information and saw that it was for inflammation and pain. She was obviously not in pain, and the spot where her tooth had been pulled looked fine, so I didn't give her anymore Rimadyl. Last Friday, she didn't want her breakfast or dinner (dry food), she still didn't want dry food on Saturday, but ate some canned. She seemed depressed and lethargic, but we have had some awful thunderstorms. She was terrified of thunder, so I thought that may have been what had her upset. In hindsight (and I am beating myself up over this), I should have taken her in to the vet first thing Monday, but I called Tuesday (yesterday) morning to get her in to see the vet early afternoon. Sometime during the morning, while I was at work, she vomited on the bed and it was a mixture of grass and blood. When I took her in, she was anemic, so they put her on an I.V. and gave her something to coat her stomach and try to stop the bleeding. She was still alive at 10:30 last night when the last person was at the vet clinic. When they went in this morning, she was gone. "I am extremely sad and upset (and my other two dogs are as well—especially my Cocker Spaniel, Hope, as she and Nikki were best buds) and can't help but wonder if I had known about the potential issues with Rimadyl, and would have ended up taking her in sooner, if she would still be with us."

June 2009 -- Is Pfizer making false claims about Rimadyl?.....

Apparently, the U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), Division of Surveillance, thinks so! In a letter dated November 24, 2008, to Dr. M. Elizabeth McKenzie, Director, US Regulatory Affairs at Pfizer Animal Health, the CVM wrote that Pfizer was guilty of violations in the form of false, misleading, or unsubstantiated safety claims about Rimadyl in their advertising of the drug. In addition, the CVM found Pfizer's Duration of Efficacy chart to contain unsubstantiated efficacy claims regarding Rimadyl. The letter states, "For these reasons, Rimadyl is misbranded within the meaning of section 502(n) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 352(n)]." The letter is signed by Lynn O. Post, DVM, Ph.D., Director of the Division of Surveillance and ends with the following Conclusion and Requested Action:

"The misleading statements in your advertisements misbrand Rimadyl within the meaning of section 502(n) of the Act, 21 U.S.C. 352(n).

"The Center for Veterinary Medicine requests that Pfizer Animal Health immediately cease the dissemination of the Rimadyl promotional items described above, and any other materials that may contain similar unsubstantiated promotional claims. Please submit a written response within thirty (30) days of receipt of this letter describing whether you intend to comply with this request, and listing all violative promotional materials for Rimadyl the same as or identical to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to me at the Food and Drug Administration, Center for Veterinary Medicine, Division of Surveillance, HFV-210, 7519 Standish Place, Rockville, MD 20855. We remind you that only written communications are official.

"The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to see that your promotional materials for Rimadyl, as well as other Pfizer Animal Health products, comply with the requirements of the Act and FDA implementing regulations."

January 2008 -- Rimadyl's Side Effects Continue to Wreak Havoc....a recent case history:

An e-mail message received in January 20008: "In October of last year (2007) I took Tiffany to her vet because she was due for her distemper vaccine. I also wanted her right rear leg and joint examined, for she seemed a little slow. Moreover, she was pulling up a bit short on her walks, something she didn't do before. The examination was about the middle of the month and was conducted, I thought, thoroughly. The vet's opinion was that she was suffering some mild arthritis (she is 12), though everything else appeared normal. She was prescribed 50mg of Rimadyl 2x daily, w/ a five day trial. After the trial period Tiffany appeared somewhat improved, and I filled the prescription. After 10 days to two weeks she appeared almost normal and seemed livelier. At the end of the month I took her w/ me to the family cottage in northern MI to close it for the season. On October 31 we went on a short walk and she was doing very well. I was satisfied w/ her progress. Everything was nominal. The next morning I went out for about an hour and left Tiffany on the bed. When I got back I went to get her out of the bedroom but found her lying down waiting for me. She got up stumbling and falling about and favoring her right shoulder. (It now seems likely that she attempted to jump off the bed--as usual--and may have fallen on her shoulder due to the immobility she was experiencing from the drug.) Frankly, she was a mess and could barely make it to the back door. Her legs couldn't support her and her hind quarters would just splay and flop. This was the beginning of a nightmarish 2 1/2 months for her, a period she very nearly failed to survive. I was immediately suspicious of the medication. I checked the Internet for more information and spent hours and hours looking into the Rimadyl connection, which is how I found your site. I was struck by how similar the circumstances of the case histories, appearing on srdogs.com, were to those experienced by Tiffany. Here she was, twelve years old, complaining slightly about a seemingly impaired gait (a walk that seemed like heaven in retrospect), being placed on Rimadyl, then finding herself stumbling, collapsing, and, just a little later, experiencing partial paralysys of the hind quarters. I felt that time away from the drug would result in her regaining her original form. The profiles on srdogs.com convinced me of this, and those stories lent me the confidence to persevere w/ her. But she seemed to deteriorate. I read extensively on the NSAID "blood brain barrier", about the active ingredient, carprofen, and its role as a COX-2 inhibitor; about Rimadyl belonging to a class of drugs called propionic acids (of which Aleve is one and the strong injunction NEVER to administer Aleve to a canine); about the wrenching, devastating side effects and possible fatal complications of the drug's use; and, finally, about the prognosis for a dog on the drug and the long struggle to endure its administration and aftermath. She also began to lose her spirit. She would sleep endlessly and I would have to massage her awake then carry her outside and in, to and from her food--just everywhere. Then, on one occasion when I carried her from outside and placed her just inside the door, she stumbled a few feet and collapsed. I was on her in a second and held her head in my arms. She didn't respond, and I called her name again and again. I thought she was gone, and I was, too. Just then her eyes flicked open, and she looked at me--as she had done so often at the time--as if to ask what was going on, what had happened to her life. Her condition was so bad that I knew that she would probably have to return to the vet. She was pushing three weeks off the drug, but it wasn't enough. And, while she could walk a bit, she would hop while doing it. The stress was showing throughout her body and spirit. Once back at the vet, my Rimadyl hypothesis was rejected. I was told that Rimadyl reactions are exceedingly rare, certainly nothing like imbalance, partial paralysis, and uncoordinated stumbling could be the consequence of such a thoroughly "vetted" medication. I was given a temporary supply of another medicine, Deramaxx, and told to go slow w/ it. After one day on Deramaxx Tiffany seemed somewhat improved. Then, but 36 hours on the same dosage as the Rimadyl (50mg), she collapsed again, in worse condition than ever. I took her to the vet again, and, this time, he agreed that the NSAIDS were intolerable for her. Now the prescription was a simple one for Tramadol for her aching shoulder--the shoulder she probably injured falling from the bed those weeks earlier. (Also, complete body x-rays revealed no joint abnormalities.) Only now is Tiffany rejoining her condition in early October. Her personality is reviving, and she is starting to climb stairs on her own. I am taking her for walks and she can go about a half mile. She still has shoulder discomfort, but we are working on that via a new diet and MSM\glucosamine supplements (no Tramadol), as well as ground flaxseed and other additives to her food. This will be quite a journey. I wouldn't have found the confidence to persevere w/ her recovery by alternate means and may well have accepted the company line about the Pfizer and Novartis miracle drugs had srdogs.com not been there to inform me of the case histories--those both happy and tragic. I am relating Tiffany's story as a recent addition to that store of knowledge; her story is not a mere anecdote as the drug and veterinary medicine establishment would have us believe. Tiffany is my companion and my friend. We have traveled and explored and lived as one. She has retrieved driftwood in turbulent Lake Superior in November. She has run the rims of sand dunes along Lake Michigan. She has chased deer in the snow-covered woods. We have played endless soccer and fought blinding winter storms. And we are sharing this rock together. Still. Sincerely, R. F. Whitmer"

September 2006 -- FDA Issues Extensive New Guidelines for Prescription and Use of NSAIDs for Dogs

The Food and Drug Administration has issued new guidelines covering the prescription and use of NSAIDs such as Rimadyl. Please review them, and be certain your veterinarian has seen them, before administering them to your dog. Also see "Pain Drugs for Dogs: Be an Informed Pet Owner," an excellent article published by the FDA.

Pennsylvania Legislature Considers Law Governing Veterinary Prescription Medication -- April 2006
The Food and Drug Administration has determined that certain drugs can only be used safely when patients and owners are provided with critical information on the safe use of the drug. For humans, this information is provided in the form of a Medication Guide. The veterinary equivalent is known as the Client Information Sheet.

Owners of pets who have suffered adverse reactions to veterinary drugs have reported to the FDA that they were not provided Client Information Sheets by their veterinarians. For the past six years, owners have appealed to no avail to state veterinary boards to mandate that vets provide this critical information to owners. Similarly hundreds of complaints have been filed against vets for not providing owners with Client Information Sheets and not one case has said that this was required.

To remedy this situation in Pennsylvania, Senators Stack, Browne, Fontana, Rafferty, Boscola, Costa and Ferlo have introduced legislation mandating that veterinarians provide clients with Client Information Sheets for the drugs that have them.

It is anticipated that similar legislation will be introduced in most other
states over the next few months.

Detailed background on this legislation is available at:
http://www.fda.gov/ohrms/dockets/dockets/04n0559/04N-0559_emc-000003-01.pdf

THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 1144 Session of 2006

INTRODUCED BY STACK, BROWNE, FONTANA, RAFFERTY, BOSCOLA, COSTA AND FERLO,
MARCH 20, 2006

REFERRED TO CONSUMER PROTECTION AND PROFESSIONAL LICENSURE, MARCH 20, 2006

AN ACT

Amending the act of December 27, 1974 (P.L.995, No.326), entitled "An act regulating the practice of veterinary medicine and imposing penalties," further providing for definitions.

The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:

Section 1. Section 3(15) of the act of December 27, 1974 8 (P.L.995, No.326), known as the Veterinary Medicine Practice 9 Act, amended December 9, 2002 (P.L.1370, No.167), is amended and 10 the section is amended by adding a paragraph to read:

Section 3. Definitions.--As used in this act:
* * *
(15) "Veterinarian-client-patient relationship" means a relationship satisfying all of the following conditions: (i) the veterinarian has assumed the responsibility for making veterinary medical judgments regarding the health of an animal and the need for veterinary medical treatment, and the client, owner or caretaker of the animal has agreed to follow the instructions of the veterinarian; (ii) the veterinarian has sufficient
knowledge of the animal to initiate at least a general, preliminary or tentative diagnosis of the medical condition of the animal; (iii) the veterinarian is acquainted with the keeping and care of the animal by virtue of an examination of the animal or medically appropriate and timely visits to the premises where the animal is kept; (iv) the veterinarian is available for consultation in cases of adverse reactions to or failure of the regimen of therapy; (v) the veterinarian maintains records on the animal examined in accordance with regulations established by the board[.]; and

(vi) the veterinarian provides a client information sheet to the owner of the animal in cases of dispensing prescription drugs that will be administered by the owner in an outpatient setting.

(16) "Client information sheet" means a paper required by the Center for Veterinary Medicine of the Food and Drug Administration for the purpose of communicating important risk information to clients and that is given to a veterinarian by a prescription drug manufacturer so that owners of an animal are provided with vital product safety information including precautions, contraindications, signs of a possible adverse reaction, and steps to take in the event of an adverse reaction to the prescription drug.

Section 2. This act shall take effect in 60 days.

Warnings about NSAIDS from a Veterinarian

We were recently forwarded a letter by Bob Rogers, DVM, Critter Fixer Hospital, Spring, TX, in which he states his policy on Rimadyl and offers a handout warning of the side effects of NSAIDs (non-steroidal anti-inflammatory drugs). Here is an excerpt:

"I have never used Rimadyl in my practice. I never buy drugs the first year they come out. I wait to see the number of reactions reported to the FDA. Unfortunately, most vets get all their information from the sales people. I have asked a Senator in Texas to introduce a bill to prohibit the approval of Continuing Education Credits for a seminar where the speaker is a paid employee of a drug company or where a conflict of interest exists. Speakers should reveal all financial ties to any products discussed. I feel this is central to the problem with Rimadyl and many other drugs. To follow is the handout I give to all clients to warn them about side effects of all NSAIDs. All the information came from Dr Dawn Boothe, pharmacology professor at Auburn."

Bob Rogers, DVM, Critter Fixer Pet Hospital, Spring, TX

Selected Reports on Experiences with Rimadyl

While the Senior Dogs Project no longer post reports of experiences with Rimadyl on a regular basis, the following seemed especially important to make available to anyone using or considering the use of Rimadyl.

August 2004

Coco, a beautiful, ten-year-old Chocolate Lab mix, died in July, shortly after she was given Rimadyl for pain associated with an ear infection. According to Coco's guardian, no client information sheet was ever offered to her and the veterinarian assured her Rimadyl would help her dog.

She says, "I would never have given this drug to my dog had I seen the information on Labrador Retriever responses to it." She writes further, "I feel she died too young due to incompetent care. I still believe that what was ailing her could have been dealt with because she had been peppy, happy, and mostly in good health. I believe the symptoms that led to her collapse implicate Rimadyl as the cause of her death and of the distressing quality of her life in her last three days. . . . Even though everyone tells me I should stop feeling guilt that I killed my dog, I still can't help but blame myself for not looking up the drug. And then I wonder if she might have survived once she got past the toxicity, but I don't think we could have watched her suffer anymore. All I know is there seem to be so many empty spaces in my home, places where she was always beside me. I have decided to channel my grief and anger by informing everyone I know about this assault on all of our animals' dignity and quality of life. Would these vets prescribe a drug to their family members if there were even the slightest possibility that it could kill them? I doubt it. . . . Let's all decide to do at least one thing a day to honor our beloved companions. If it's telling one other person, or posting information somewhere or filing complaints with any and every state and federal agency, we can change the world -- one message at a time. But in between this let us all take the time to remember our companions for the happiness we shared and how much they gave us. For Coco."

January 2004

An e-mail message from labs2love@comcast.net 1/3/02, reports a death, with Rimadyl suspected as the cause: "I am writing this in a great deal of grief. I lost my 14-year-old Yellow Lab, Chestnut, yesterday, New Years Day, 2004, from a massive stroke, after she had been on Rimadyl for twelve days. She was a healthy dog -- only some arthritis. While waiting for surgery to be done on Monday, January 5, 2004 (the earliest possible appointment I could get), my vet gave me Rimadyl to 'make her feel better' until he could remove a lymphoma, that he assured me was harmless, from under her left front leg. She started the Rimadyl on Saturday, December 20, and I gave it to her twice a day until yesterday morning, January 1, 2004, twelve days later. Her appetite had diminished, but she ate to make me happy. I had to spoon feed her. Chestnut's abdomen had swollen in the previous three days also, even though she was eating less and not finishing her meals. I had to decide to put Chestnut to sleep after this massive stroke, as she could not walk, she had to have surgery and there did not seem to be any alternatives. Money was no object, but there was no answer!! I said good-bye to her....she really was not there, as I felt her pass in my arms at home before I got her to my vet. One and one-half hours after her lunch and last Rimadyl, Chestnut was gone. When I got home something made me look up Rimadyl on the internet and I could not believe what I was reading. I am lost without her. I pray I did the right thing for her. She had so much pride. I could not bear to see her suffer any longer. "

E-mail received from sisterohio2002@adelphia.net ,11/16/03, reports a positive experience with Rimadyl: "We recently put our 12+-year-old, 60-lb. Redbone Hound on Rimadyl. We cautiously watch him for signs of side effects. So far, after 45 days, nothing is amiss. Twice a day, before each feeding, we give him 750/600 mg. glucosamine/chondroitin, one-half capsule plant digestive enzyme ('Now' brand), one Lactaid tablet (9,000 units), 500 mg. ester C, 75 mg. Ranitidine, 1000 mg MSM, two tablespoons flaxseed oil, and one tablespoon nutritional yeast, crushed and mixed with two tablespoons full-fat yogurt. He was on this program for about a year, and it seemed to help his hypertrophic arthritis for a while (the MSM particularly helped to reduce joint swelling), but, about six weeks ago, he became lethargic -- had sunken eyes, would not drink much water, and seemed to be in a downward spiral. When the vet recommended Rimadyl, we were concerned about the side effects, but, at the rate he was going, it seemed as though he wouldn't be with us much longer. Since he's been on the Rimadyl, we have a lively, vibrant, and once-again very strong family pet. He is walking better, can drag a short piece of railroad tie around the yard again, as he did when he was a pup, he is happy, hungry all the time, friendly, and back to his old 'self.' With his stomach problems and his arthritis, we know he won't be with us much longer, but we feel it is worth giving Rimadyl a try."

December 2003 -- According to Damian Adams of South Australia, whose dog suffered a fatal reaction to Rimadyl (see October 2003 report below), "New scientific information shows that Rimadyl can cause clotting conditions such as thrombosis, ischaemia and infarctions. These conditions have been previously excluded as a Rimadyl adverse reaction and Pfizer does not acknowledge the evidence (yet). An infarction caused the death of my 6-year-old Newfie Baxter while on Rimadyl and I am trying to draw Pfizer Australia's attention to this evidence as they have previously concluded that Rimadyl did not cause his death. Rimadyl (Carprofen) is a cyclooxygenase-2 (COX-2) selective inhibitor in canine cells (Pfizer's own printed publications including studies of Ricketts et al.) Prostacyclin is a product of COX-2; it increases blood flow, reduces leukocyte adherence and inhibits platelet aggregation. Its inhibition increases the risk of acute vascular events in canines receiving COX-2 inhibitors (Hennan et al., 2001), and could promote thrombosis (Widlansky et al., 2003) which could lead to an infarction. Selective COX-2 inhibition blocks prostacyclin (PGI-2) formation without inhibiting TXA2 (thromboxane)(McAdam et al., 1999, and Catell-Lawson and Crofford, 2001), thereby increasing platelet activation, adhesion and aggregation with a resultant possibility for thrombosis and ISCHAEMIC events (Pitt et al., 2002). Non-concomitant inhibition of COX-1 (for which Rimadyl does not inhibit) which mediates the actions of TXA2 (a platelet aggregating promoter) may increase the risk of thrombosis with selective COX-2 inhibitors (Christopher Jones, Veterinarian, Gulf Coast Veterinary Specialists, Houston, Texas). This is but a brief sample of the scientific data, peer reviewed journal articles and publications by both scientists and veterinarians that point to the distinct possibilty of an clotting condition arising from the use of selective COX-2 inhibitors such as Rimadyl.

References:
Ricketts AP, Lundy KM, Seibel SB 1998. Evaluation of selective inhibition of cyclooxygenase 1 and 2 by carprofen and other nonsteroidal anti- inflammatories. J. Vet. Res. 59(11): 1441-1446.
Hennan JK, Huang J, Barrett TD, Driscoll EM, Willens DE, Park AM, Crofford LJ and Lucchesi BR 2001. Effects of selective cyclooxygenase-2 inhibition on vascular responses and thrombosis in canine coronary arteries. Circulation 104 (7): 820-825.
Widlansky ME, Price DT, Gokce N, Eberhardt RT, Duffy SJ, Holbrook M, Maxwell C, Palmisano J, Keaney JF Jr, Morrow JD and Vita JA 2003. Short and long-term COX-2 inhibition reverses endothelial dysfunction in patients with hypertension. Hypertension 42(3): 310-315.
McAdam BF, Catella-Lawson F, Mardini IA et al. 1999. Systemic biosysnthesis of prostacyclin by cyclooxygenase (COX-2); the human pharmacology of a selective inhibitor of COX-2. Proc. Natl. Acad. Sci. USA 96: 272-277.
Catella-Lawson F and Crofford LJ 2001. Cyclooxygenase inhibition and thrombogenecity. Am. J. Med. 110: 28S-32S.
Pitt B, Pepine C and Willerson JT 2002. Cyclooxygenase-2 inhibition and cardiovascular events. Circulation 106(2): 167-174.
Jones C. Practical COX-1 and COX-2 pharmacology: What's it all about?

October 2003: A Report from South Australia -- Baxter, a six-year-old Newfie experiences negative side effects following low dose of Rimadyl

We are keeping in our thoughts a dog named "Baxter," who is fighting to recover from side effects of Rimadyl. Here is Baxter's story as reported to us by Damian Adams of South Australia:

"Baxter, our six year old Newfie, was always a picture of health and the most gentle soul we had ever met. He developed a sore/inflammed disk in his neck which made it painful for him to feed from his bowl or to lie down. Our vet prescribed Rimadyl at a dose lower than the maximum allowable. After four days Baxter was much better and we removed him from the drug on the Tuesday morning, giving him his last dose with his breakfast. Within an hour he was vomiting, couldn't pass any faeces, was depressed and had a swollen, painful belly. His behaviour became erratic -- at times he was unwilling to move and at others he had enough energy to dig up the entire garden, something he has never done. He even refused all food and treats, which is very un-Newfoundland like. Baxter was rushed to another vet closer to our home who could find no reason for his illness -- no elevated temperature and no bowel/stomach blockage. He was given an injection to stop the vomiting and was sent home. I mentioned that he was on Rimadyl, but the vet did not bat an eyelid. The next morning he vomited blood and was rushed back to the first vet who took blood and put him on a drip. The blood tests showed stomach inflammation and mild pancreatitis, none of which pointed to how sick he actually was. Knowing that it was too coincidental, I did a web search and found your very informative site as well as others, including Pfizer who now admit that it can cause such gastrointestinal problems such as pancreatitis and present the symptoms we were seeing. I have since mentioned the possibility of Rimadyl being a cause to the vet who did concur that he had thought about the possibility but that he had also not had any problems with the drug in all of the years he has administered it. Now I sit and wait to see how Baxter does on the drip, being completely distressed about the fact that something I have given him could kill him. Baxter weighed 80kgs (176 lbs) and started on a dose of 200mg per day (1x 100mg tablet in the morning and one at night) for the first three days; then we reduced it down to 100mg per day for the next three days (including the day he became extremely ill). This dosage is well below the maximum allowable, according to Pfizer the initial dose is only 57% of what we could give him. In the first 30 hours of sickness, Baxter lost 3kgs of body weight." Yours faithfully, Damian Adams. South Australia. September 17, 2003. Update October 30, 2003: "Baxter was euthanised on September 19 due to small intestine necrosis that could not be treated with surgery. This necrosis was most likely caused by mesentry ischaemia -- blood clots that stopped the supply of blood to his small intestine (according to the pathologist's report). While neither the vet nor pathologist acknowledge Rimadyl to be the cause of this, it is known that gastrointestinal bleeding can occur when using Rimadyl. The mesentry arteries belong to the GI system. I have contacted Pfizer Australia and have notified them of an adverse reaction. They have contacted me to obtain information on Baxter and the treating vets. I am yet to hear back as to their conclusions."

September 2003: One Positive and Several Negative Reports

On a positive note, an e-mail message from Val T.: "We have a 16-year-old American Eskimo Dog named Frosty. He has been on Rimadyl for almost three years for arthritic hips and spine. We give him the pill with a small piece of cheese to help him get it down. He receives 1/2 pill in the morning and 1/2 pill in the evening, totaling 25mg a day. Frosty weighs 15 lbs. and was as healthy as a horse until the arthritis. Our vet does a blood chemistry on him every six months. He is just now starting to show high urea levels in his blood. The most important thing is to keep up the blood work, since Rimadyl can damage the kidneys. At this time he still has a wonderful quality of life...thanks to Rimadyl. Without Rimadyl, we would have lost him."

Negative reports: A 5 1/2-year-old Bichon Frisee named Molly underwent surgery for bladder stones on June 12, 2003. The night after surgery, when she exhibited pain, her guardian called the vet; he prescribed Rimadyl. The veterinarian did not advise the client of the potential side effects, thus, the client did not recognize them when they appeared (after the initial dose) and she continued to administer Rimadyl. After the third dose, she withdrew Rimadyl, but, by then, it was apparently too late. She writes: "On June 17, I woke to find Molly's little belly bulging. It was apparent she was in acute renal failure. She had not urinated since the morning of June 14. I kept asking the vet if this was all right, but I never was given an answer. I brought her into the vet that morning; he catheterized her and did a blood test. He said the numbers were extremely high and that, if she came out of this, she would have 25% kidney function. ... Molly had always been a healthy dog other than the bladder stones. The only answer I was given when I asked the vet if it could be the Rimadyl was, 'I didn't send her home with it; you called and asked for it.' I was shocked and could not believe what I was hearing. I took Molly home and she grew larger and her heart beat was becoming more intense. On June 19, shortly after midnight, Molly passed away in my daughter's arms while having a violent seizure. It was the most heart-wrenching experience either one of us has ever endured." -- Reported by Candy S.

Duchess, a 7-year-old Great Dane with slight lameness was given Rimadyl for about a week, during which she collapsed with a GI hemorrhage. After a week of intensive care, she was euthanized. Since she was in good health up to this time, Rimadyl is suspected as the cause of her death. The same person reports that her 2-year-old Great Dane was also given Rimadyl for lameness, but that it became worse, not better while on the drug. The veterinarian then increased the dosage, and she became worse still. When she was unable to get up or stand, blood work was done, but showed no problem. The vet suggested it was a brain tumor. After withdrawing the Rimadyl, the dog was able to stand and walk and improved significantly. -- Reported by Ann V.L.

Food & Drug Administration/Center for Veterinary Medicine reports of deaths associated with Rimadyl (Carprofen) -- cumulative:

May 1, 2003 - 2,133 dogs have died
June 4, 2003 - 2,153 dogs have died
July 8, 2003 - 2,182 dogs have died

Previous annual reports of deaths associated with Rimadyl (Carprofen):

Year 1997: 195 dogs
Year 1998: 456 dogs
Year 1999: 371 dogs
Year 2000: 470 dogs
Year 2001: 537 dogs

September 2002: ALERT!!! Four-year-old Peke-a-Poo Almost Dies While on Rimadyl

From B. Kemp, Dickson, TN "Last week, we almost lost our 4-year-old Peke-a-Poo due to Rimadyl. We were never told of any side effects or that he should have had bloodwork done during the year he was on it. I started the research on Rimadyl, trying to save him. He started bleeding profusely from the rectum and throwing up blood. We rushed him to the vet, who operated on him and found all his organs enlarged. His stomach was bleeding, his gallbladder was 30 times its normal size and full of blood, and the kidneys were slowing down. He was in the hospital eight days and, thanks to prayers, we have him home and on the mend. I will never trust another vet to give medicine without doing research myself. This was a terrible way to learn that lesson. I hope someone learns from our mistake."

Twelve-year-old Lab/Boxer Mix Thrives On Rimadyl

From an E-mail received March 15, 2002:

"I have a Black Lab Boxer mix named Buster and he is 12 years old. He has been on Rimadyl for six (sic) years. He had a knee problem that they could not solve. We had surgery (exploratory). As he aged, he became stiffer. Once we put him on the Rimadyl, it made such a huge difference; he could run and play again. His arthritis has progressed so much that we (my husband, myself and our vet) just recently (about six weeks ago) adjusted his dosage to two 100 mg tablets twice a day. He still gets around pretty good. We have always had his liver and kidney functions checked and they have been fine. I believe that Buster would not have lasted this long if not for Rimadyl." (Editor's note: Rimadyl has been available only since January 1997. If the dog began Rimadyl therapy at the drug's introduction, he would now be in the first quarter of the sixth year.)
LoriJRCamp@aol.com

Communication between Client and Veterinarian a Critical Element in Good Pet Care

From Dr. Kristi Fisher, DVM, February 2, 2002:

"I was directed to your website by a client who was sure we were guilty of malpractice for prescribing Rimadyl and prednisone together. This is a dog with severe burns over most of his body, so he is on an extremely low dose of prednisone for two weeks while on the Rimadyl as needed for arthritis. I assured the client that this was ok, and gave him signs of ulceration to watch for.

"I was rather dismayed by the Rimadyl reports, however. I have seen two adverse reactions in two Laboradors which, when treated, the dogs responded just fine. So many of the symptoms people were describing in the reports fit that of many other diseases common to old age. One person complained about blood panels not being done and the chart not being read to see what the dog was taking, etc. I agree that this presents a problem. I require blood panels every three months on patients on Rimadyl. In most cases, I require some sort of blood panel before starting it. However, what pet owners need to realize is that reactions to Rimadyl are very infrequent. Unfortunately, when an adverse reaction occurs to your pet, it is goes from infrequent to 100%.

"Rimadyl is an excellent drug for providing comfort for dogs with arthritis. Routine monitoring should be done (as with any long term medications). Especially in older pets, do not let signs of disease go unchecked before bringing them in to be examined like you can usually do in a younger animal. Also, do not be quick to blame the medication. I see MANY older patients go downhill very quickly that are not on any medications. Most of all, owners should be sure to discuss any and all concerns with their veterinarian. If they are not satisfied, find another vet. This profession is based on client communication to best serve the pet." kristina@mvah.com

Newfoundland with Osteosarcoma Would Not Be Alive without Rimadyl

Received February 14, 2002:

"I just wanted to share a brief story with those seeking comfort in knowing that your pet CAN live longer and pain free being on Rimadyl. We have two beautiful male Newfoundlands. To our greatest grief, our youngest one (Otis, three years old) was diagnosed with the devastating and rapidly spreading bone cancer 'osteosarcoma.' He was in a lot of pain and we just did not know what to do other than follow our vet's advice, which was to either amputate or seek relief through the help of medication. Being that he's too big a dog to be limping on three legs, we opted for the medication. He is currently on twice the allowed amount (500mg) and he is doing fantastic. If it wasn't for Rimadyl we would have had to put him down a long time ago. He probably has at best three more months to live. He was diagnosed about four months ago, and this disease is fatal 100% of the time in six to eight months, with or without treatment. We opted for quality and a pain-free life style for him. Hence the Rimadyl. Only problem is the price of the medication! Hope this help anybody going through the same thing. Robert_Zeepvat@sentrixhealth.com

Senior Golden Retriever Derives Comfort and Is More Energetic on Rimadyl

Received February 21, 2002:

"I read with horror the February newsletter and the story of Ginger (report shown below) and her Rimadyl experience. I also have a senior Golden Retriever. He has hip displaysia and has been on Rimadyl for almost two years. At the time I started him on it, there were no stories of adverse effects other than the potential kidney problems. I decided that it was worth a try to make my old boy more comfortable. I am happy to say that within about three weeks he appeared much more comfortable and had fewer problems getting up after lying down. With steady doses of Rimadyl, glucosamine-chondroitin and exercise, he appears much better. He has also lost about seven pounds, due to the exercise he can now endure. I just want to be sure that everyone isn't scared off by the Rimadyl horror stories. There will always be cases of adverse effects to every drug due to the uniqueness of every living thing on Earth. The additional comfort and energy that Rikko has gained from Rimadyl is something that every senior dog plagued by arthritic or other mobility problems deserves a shot at. Rikko will be 10 on March 6, and his health is much better because of Rimadyl. Just wanted to be sure that both sides of the story were represented on your site. sherryi@microsoft.com

Rimadyl Prescribed in Complicated Case May Have Accelerated Death

Received February 27, 2002:

"I wanted to contact you because I felt the need to share with you our painful experience with Rimadyl and the subsequent (untimely) death of our beloved little man 'Bushky' on November 30th, 2001. What had started as a simple visit to the vets for an ear infection ended up with a diagnosis of hypothyroid and the subsequent administering of a series of drugs (which included Rimadyl, later Etogesic and Prednisone) that never really got to the root of my dog's problem until it was too late. Bushky we learned, after a month-long series of tests, misdiagnoses and mismedication, had Cushings disease. At one point during this painful ordeal, my vets believed that Bushky's now less-than-peppy spirit was probably due to arthritis . Although the x-rays showed no signs of osteoarthritis, the vets administered Rimadyl. A couple of days afterwards, Bushky began a steady and marked decline. . . . He died on Friday morning at 4:30 am. His sudden and swift deterioration had been a piercing question mark. It was not until I happened to come across the Senior Dogs project site and read the experience of others with Rimadyl did I start to understand. I had turned to other vets to ask them about Cushings to confirm whether this could be the underlying cause and their response was always the same: this disease is not known to cause paralysis and is in itself rarely life threatening. All I know is that Bushky was his usual chipper self that morning I took him in for his ear infection, and that he had never demonstrated any other serious ailments before. I truly believe that he would have been alive today had I been warned of the side effects of this drug. In my case, as in many others I have read, it is very true that the treatment was worse than the (suspected) illness. Thank you for your efforts in warning others about this drug and making those accountable live up to their responsibility." EMinoso@aol.com

German Shepherd Succumbs to Suspected Rimadyl Toxicity

Received February 22, 2002:

"I just lost my German Shepherd about two hours ago due to what I believe is an adverse reaction to Rimadyl. He was 11 years old, in great health except for recently diagnosed arthritis. He was on Rimadyl for four days. This morning, after going out, he was having trouble walking and getting up, and kept drinking tons of water. My husband took him back out, and he collapsed. He took him to the emergency animal clinic and they started him on glucose and diagnosed internal bleeding. He even needed oxygen to breathe. He made it to the vet's office, and they decided to do exploratory surgery to find out what was causing the bleeding; they thought maybe a tumor or ruptured spleen. He didn't make it through the surgery; he had already lost too much blood. Our hearts are broken. What can we do to prevent this from happening to someone else, and how can we hold Pfizer responsible? I wouldn't care how much it cost me, if he had pulled through; now we have no dog and a huge bill from two animal hospitals. What do we do now?" tarheelmom@hotmail.com

AIHA Surfaces in Dog Following Four Days of Rimadyl Therapy

From an E-mail received from B.A.R.K.S. campaign headquarters, February 2002:

"After four doses of Rimadyl, my dog nearly died from hemolytic anemia. Her PVC was down to a count of 6! I unfortunately did not research the drug beforehand. My dog is not quite five years old and was suffering some stiffness, for which the vet prescribed Rimadyl. On New Years Day, she started lying around and did not want to eat...I wasn't alarmed at the time...wondered if the drug could cause nausea. Had it not been New Years Day, I would have called my vet. Instead, that night I logged onto the Internet. I luckily found the Senior Dog site. I printed out the symptoms. That saved her life, I have no doubt. I looked at the list of symptoms and then looked at my poor little Sheltie. I realized something was drastically wrong when she nearly fell over. (I did not have enough sense to look at her gums, which I later discovered were white.) Thanks to the Senior Dogs site, I realized she could be seriously ill. I rushed to the vet, he wasn't there yet, but I just waited in the parking lot...trying to decide what to do. Fortunately they finally showed up. By noon, they were giving her a transfusion. I took her home two days later, but had to take her back after a little over 24 hours. This time they kept her about 5 days. I feel my vet has done a wonderful job of handling this. It has been 30 days at this point, and her PVC is only 29, and she is still on prednisone. So I guess she is not out of the woods completely. But I have hope now, anyway, which I didn't have before."

Seven-year-old Golden Retreiver "Ginger" Dies Eighteen Days after Beginning Rimadyl Therapy

From an E-mail received January 28, 2002:

"Our family's beautiful 7-year-old Golden Retriever, Ginger, had to be euthanized 1/24/02. She had been taking Rimadyl for about 18 days. She was fine and healthy when we took her to the vet for minor stiffness, and now she's dead. We did not receive any warning of the potential side effects of Rimadyl, and followed the veterinarian's instructions in administering it. We gave it to her until we started to notice some unusual behavior. First, she stopped eating.... then stopped drinking water....different urine patterns and urine accidents in the house....then vomiting....diarrhea....then jaundice. We stopped the medicine and went to see the vet. He said she was having an adverse reaction to Rimadyl and to keep a close eye on her. A day later, we had to take her to an emergency veterinary hospital because our regular vet was closed for the week-end. She was given intravenous fluids. On Monday, we transferred her back to our vet for continued care at his facility. He said she was hanging on, and they were doing everything they could for her. Finally, after being on IV's for six days with no success, the vet called and said she was not responding and slowly deteriorating and dying, and they had nothing else they could do. We went to the vet to see her for the last time. She just lay in her kennel. We started to pet her and she put her head up a little. She started to gag and tried to vomit, but it was just dry heaving. Her one eye was swollen and she couldn't even wag her tail. We all cried and hugged her. She was the love of our life and truly a member of our family. She brought us so much joy. If only we had known all the facts about Rimadyl. We have sent her body to Colorado State University for an autopsy to prove that Pfizer's Rimadyl killed our beloved Ginger." grodgers@umd.umich.edu

Drs. Foster & Smith Links Rimadyl Info Sheet to Their Website

We commend Drs. Foster & Smith for a recent change in their website, which enables consumers to go directly to their own and then Pfizer's consumer information sheet about Rimadyl. This is the link provided: http://www.peteducation.com/newsviews/00_june_rimadyl_infosheet.htm

Insights from the FDA's Center for Veterinary Medicine
The following is excerpted from an article that appeared in FDA Consumer magazine November-December 2000 entitled, "Prescriptions for Healthier Animals: Pets and People Frequently Fight Disease with Similar Drugs," by Linda Bren

Much as they do in managing their own health-care, people need to weigh the benefits and risks of a drug prescribed for their pet. It's the veterinarian's responsibility to explain the risks and benefits of each drug to clients, and give them printed information, particularly for the drugs that aren't approved for animal use, says Karen Overall, VMD, Ph.D., professor of behavioral medicine and director of the small animal behavior clinic at the Veterinary School of the University of Pennsylvania. "It's important that we have the informed consent of our clients."

Pet owners should ask their vet questions about any drug being prescribed for their animal--especially in the absence of printed information. Although manufacturers provide a label, or printed information, with each drug they give to veterinarians, says Bataller, "in repackaging the drug at a veterinary facility, the label often does not get passed on to clients. And if the drug is prescribed extralabel, the label would be of limited value to the pet owner."

FDA has helped two animal pharmaceutical companies develop consumer-friendly labels that explain the benefits and risks of their osteoarthritis drugs for dogs. Fort Dodge Animal Health of Overland Park, Kan., distributes a "client information sheet" with EtoGesic (the generic drug etodolac). Pfizer Animal Health, Inc., of Exton, Pa., gives out a client information sheet with Rimadyl (carprofen). Both drugs are non-steroidal anti-inflammatory drugs (NSAIDs).

Pfizer provided the Rimadyl information at CVM's request following a high volume of adverse events, including deaths, reported by owners whose dogs were treated with the drug. The angry owners, who were not properly informed of the drug's risk, prompted the new labeling that will better help other pet owners decide if the drug is appropriate for their dogs.

Although pet owners are becoming better educated and informed about animal treatments, it is still unwise for them to medicate their animals without veterinary supervision, warns Bataller. "Different species metabolize drugs differently. A dog is not a small human, and a cat is not a small dog," he says. "Some drugs may be better tolerated in a dog than in a human, while other drugs may have the reverse effect. Dogs are generally more sensitive to aspirin than humans, and Tylenol (acetaminophen) can readily kill a cat."

The article in its entirety may be read online at: http://www.fda.gov/fdac/features/2000/600_pets.html

Negative Reactions to Rimadyl Continue to Occur; Consumer Information Sheet Not Being Distributed

October 2000 -- Incidents of negative reactions to Rimadyl continue to appear on various bulletin boards and E-mail lists on the internet. These are the common themes that continue to surface:
(1) Even though Pfizer has supposedly distributed them to veterinarians and instructed that they be dispensed along with any Rimadyl prescription, consumers are still not being given information sheets describing the potential side effects of the drug.

You may recall that in April 2000, Pfizer issued this statement in a press release:

"EXTON, Pa., April 20 /PRNewswire/ -- A trip to the veterinarian just became more like a visit to the neighborhood pharmacy. Pfizer Animal Health is leading the industry as the first animal health company to provide pet owners with easy-to-read pet medication information sheets. The Owner Information Sheets (OIS), containing important medical information about veterinary prescriptions in a reader-friendly, question-and-answer format, will debut this month with prescriptions of Rimadyl(R) (carprofen) Caplets and Rimadyl(R) Chewable tablets."

(2) Veterinarians still seems unaware that Pfizer advises against the concurrent use of Rimadyl and corticosteroids such as Prednisone.

(3) Blood panels are not being advised or offered as a choice to consumers whose dogs are being prescribed Rimadyl.

Chicago Pet Program Host's Coverage of Rimadyl
In a serialized format, Steve Dale, host of Chicago's "Pet World" show has written an excellent article on Rimadyl. It is in four-parts and it is worth reading

E-mail: Steve Dale: PetWorld@AOL.COM

Informational Video on Rimadyl
B.A.R.K.S. ("Be Aware of Rimadyl's Known Side Effects"), the consumer group that has organized a massive educational campaign about Rimadyl, has produced a very professional and informative video. It brings the updated story of Rimadyl to life in a highly visual and interesting format.

The tape is an overview of Rimadyl from when it first came on the market through March 2000. It's an easy way to learn about Rimadyl and to share the information with others. Those who are interested can seek out details and full documents.

Among the statistics cited in the video are the following:

Total ADEs (Adverse Drug Events) for Rimadyl reported to the FDA's Center for Veterinary Medicine in 1997 and 1998: 4,596 including 651 deaths.

Also very startling to note is that it is generally agreed among statisticians that most figures reflect only 10 to 15% of actual cases. This would mean that, in reallity, there may have been as many as 31,000 to 47,000 ADEs to Rimadyl in the two years reported.

To order the video, mail a check for $4.00 made payable to "Jane Sinclair" to:

Cheryl Watton
Advance Multimedia
29374 Northwestern Highway
Southfield, MI 48034

Phone: 248.350.2130

E-mail: advmm@earthlink.net

B.A.R.K.S. Campaign Alert -- Fraudulent Practices

Organizers and representatives of the B.A.R.K.S. campaign have reported unauthorized use of the campaign slogan and fraudulent practices pertaining to the sale and distribution of campaign materials on the Internet.

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An Editorial Note
This site presents approximately 200 reports of adverse experiences with Rimadyl. Also presented are approximately 90 testimonials and reports from people who have used Rimadyl successfully, including those from proponents of the drug who say their dogs were saved from euthanasia by Rimadyl. It is not our intention to discourage the use of Rimadyl. Clearly, it has helped a great many dogs and is unquestionably preferable to euthanasia.

By presenting information on this website, we hope to increase awareness of Rimadyl's potential side effects so that informed decisions can be made and appropriate monitoring pursued when the drug is used. We hope that this information will eventually eliminate any dog's suffering the potentially serious side effects of Rimadyl because symptoms of an adverse reaction were not recognized and the drug not withdrawn in a timely manner; or because recommendations for baseline testing and regular monitoring were not followed, and the drug was not withdrawn in time to avoid causing irreparable organ damage.

How common are side effects to Rimadyl? According to Pfizer Animal Health, the manufacturers of Rimadyl, side effects from the drug occur in less than 2/10ths of 1% of all dogs. They also state, "Approximately 70% of the Rimadyl-associated adverse drug event reports received by Pfizer Animal Health have been in older dogs (i.e., older than eight years)."

The article on Reports of Adverse Drug Experiences in the January/February 1999 issue of "FDA Veterinarian" offers statistics showing that Rimadyl accounted for approximately 30% of all Adverse Drug Experience reports for 1997 and ranks at the top of the list of ten drugs for which ADE's are most often reported. Rimadyl led the group of the "top ten" by a large margin: ADE's reported for Rimadyl in 1997 = 1,270; ADE's for the second drug in the list, "Domitor" = 291. Rimadyl = 33.3% of all ADE reports; the next highest percentage for all ten drugs = 7.6%.

The December 1999 update from the Center for Veterinary Medication (CVM) stated: "Of all the ADE reports CVM received in 1998, thirty-nine percent (39%) or 3,626 involved Rimadyl. The number of ADE reports received by CVM for Rimadyl is considerably more than that received for other animal drugs. For any one ADE report, there is no absolute certainty that the suspected drug caused the effect. The adverse effects in these reports are consistent with those expected for NSAIDs. They typically involve the gastrointestinal system, renal/urinary system, hematopoietic (blood) system, neurological system, and the liver. Approximately 13% of the 1998 Rimadyl ADE reports for dogs involved death of the dog, either on their own or by means of euthanasia."

How accurately do the statistics reflect the real world? This is a question that the Senior Dogs Project feels requires further investigation. The FDA itself has stated that incidents of adverse experiences are underreported. And, as we noted above, it is generally agreed among statisticians that most figures reflect only 10 to 15% of actual cases. This would mean that, in reallity, there may have been as many as 31,000 to 47,000 ADEs to Rimadyl in 1997 and 1998.

It has been pointed out that aspirin, which is widely used, also has side effects in humans including death (from bleeding ulcers -- over 7,000 annually in the U.S., according to one report). In general, aspirin is considered a safe, effective drug, however. Further, in a recent article by David J. Morrow in the New York Times (January 4, 1999) the statistics quoted were as follows: 13,000,000 Americans take non-steroidal anti-inflammatory drugs annually; 20,000 are hospitalized and 2,600 die while taking the drugs.

Particularly pertaining to senior dogs is the issue of correct diagnosis and reporting of adverse drug events. It is often assumed that an older dog is simply manifesting the signs of aging, and appears to "die of old age," when, in fact, it was a drug reaction that precipitated a chain of events that caused or accelerated the death. There may be a substantial number of cases of adverse reactions to Rimadyl that go unreported for this reason, and also cases in which dogs are euthanized because the symptoms of their adverse drug reaction mimic those of a condition, such as liver failure, that is considered irreversible. (See "Barney's" case, # 18, in 1999 Reports.)

It is important to note that, in all but a few of the reports of adverse events presented on this website, the veterinarian prescribing Rimadyl either failed to give warnings about the drug's potential side effects or told the client they were insignificant. Before making the decision to give your dog Rimadyl, we encourage you to become fully informed about the drug's benefits and risks, to evaluate whether your veterinarian is fully informed about potential side effects and recommended pre-testing and monitoring, and then to review with your veterinarian the benefits of the drug versus the risks for your dog in particular.

We encourage you to read as many of the case histories and as much of the information posted on this site as you can (all accessible via the navigation bar at the left.) You will most definitely want to read the most recent edition of the Rimadyl package insert. Pfizer has amended the insert to include new warnings required by the FDA due to the growing number of reports of adverse experiences with Rimadyl. Now that Pfizer has begun its program of providing an "Owner Information Sheet" (OIS) with each prescription for Rimadyl, the discussion of side effects and benefits should be easily accessible. If your veterinarian fails to provide the OIS with your prescription, ask for it.

Keep in mind, as you read the case histories on this website, that the normal tendency is for people to report negative experiences rather than positive. Many of the side effects reports are also "anecdotal," in that neither Pfizer nor the FDA has established a clear causal relationship between taking Rimadyl and the observed effects. We recognize that every report presented on this website does not scientifically establish that Rimadyl caused the adverse experiences described. We make no scientific judgment, but rather present the cases as part of an unbiased attempt to add to the growing body of information that may ultimately form a more complete picture of how Rimadyl works and how it may best be prescribed and administered. A number of the case histories have, however, been verified by Pfizer and/or the FDA as incidents of Rimadyl toxicity. In all but a few of the cases presented, the adverse events are those named in the Rimadyl package insert, owner information sheet, or technical bulletins as potential side effects of the drug.

Also keep in mind that the fact that testimonials to Rimadyl have been voluntarily contributed speaks to the perceived effectiveness of the drug, although it is also true that all these benefits reports are "anecdotal."

You can help in the effort to insure Rimadyl's safety by reporting any suspected ADE's to Pfizer at: 1-800-366-5288 and to the FDA at: 1-888-332-8387 (or 1-888-FDA-VETS). For step-by-step instructions, click on "If You Suspect Your Dog Has Had a Toxic Reaction to Rimadyl" in the navigation bar at the left.

Highlights of Recent Advisories

The Center for Veterinary Medicine recommends monthly blood panels while a dog is taking Rimadyl to check for liver and kidney damage.

When using chewable Rimadyl, keep the container out of reach of any animals. The enticing aroma -- dogs are known to chew through the container to get to it -- has caused a number of dogs to ingest a potentially fatal amount of the drug. Pfizer has under consideration a warning label concerning this issue; however, veterinarians often dispense the drug in a plain container that may not have the warning label

Approximately 70% of the Rimadyl-associated adverse drug event reports received by Pfizer Animal Health have been in older dogs (over 8 years of age).

Therapies that may interact with Rimadyl include other NSAIDs, corticosteroids, phenobarbital, medications for cardiac disease such as ACE inhibitors and furosemide, and drugs that bind to protein in the blood.

A review of important issues related to Rimadyl:
(1) Is Pfizer doing enough to inform and educate veterinarians and the public about the administration and possible side effects of Rimadyl?
(2) Are the potential side effects too serious for any situations but those in which there seems to be no safer alternative? (3) A new drug often produces side effects that were not evident in the clinical trials that led to its FDA approval. However, is the incidence of deaths and other severe debilitation seemingly attributable to Rimadyl within acceptable FDA limits?
(4) Is Pfizer consistent in recognizing when Rimadyl is implicated and in reimbursing for related medical expenses?
(5) Is it appropriate for Pfizer to require that "gag" orders (Confidentiality Agreements) be signed in exchange for payment of medical expenses to people whose dogs have taken Rimadyl and had adverse drug experiences?

Pfizer Kills Dogs, Too!

2009-10-19T12:37:00.000-07:00

This drug made Suzi violently sick until she had to be put to sleep.

http://www.cactuscanyon.com/syn-flex-flexicose-safe.htm

Dogs With Arthritis Do Well On Rimadyl Until They Die
Rimadyl Side Effects Detailed

In an article published in the Wall Street Journal in 2000, Rimadyl was called a drug that was made for television. It had received approval for human usage but is marketed towards Fido (yes, your dog). Your arthritic dog may take Rimadyl, but at what cost?

Take a 6-year-old Siberian Husky named Montana as an example. Montana was experiencing stiffness in his back legs and was on Rimadyl. In the beginning, Rimadyl seemed to work, but soon Montana didn’t want to eat. He soon went completely limp and would wobble instead of his normal walking. Soon he didn’t move at all. He began to eat leaves, vomit and have seizures. Eventually he was put down. The autopsy revealed liver damage commonly associated with bad drug reactions was his murderer.

Rimadyl Side Effects Ignored

Rimadyl is one of the biggest sellers in the pet drug industry. Over 4 million dogs have been given the drug costing tens of millions of dollars. Pet owners were not told the risks their pets may experience. Montana’s owner agrees. After letting Rimadyl’s manufacturer, Pfizer, know her situation they tried to buy their way out. Montana’s owner was offered $440 as a good will gesture and to help with medical costs. In order to keep the blame on Pfizer, his owner refused the money.

After numerous reports like Montana’s, the FDA suggested Pfizer should mention “death” as a side effect in letters to vets, on labels and during television ads. Eventually, Pfizer used the horrid word in the letters and on labels, but to actually say the word was more than they could do. Instead Pfizer dropped all audio commercials.

Since its release in 1997, Rimadyl has gotten about 1,000 reports of dogs that have been put to sleep or died from using the drug. Over 7,000 dogs had terrible reactions to the drug. Vets are now required to take precautions and advise dog owners of the horrible and possible deadly reactions caused by Rimadyl. It is sold as an anti-inflammatory medication. One veterinarian called the drug effective but also said the side effects were a huge problem.

Rimadyl Side Effects Can Be Deadly!

The first of the complaints appeared within months of Rimadyl’s launch with troubling reactions. Particularly Labrador Retrievers were affected. The product was first tested on young Beagles, but Pfizer soon conducted a small test only for Labradors. The Food and Drug Administration got only 3,000 animal drug reports about bad reactions on 1996, but in Rimadyl’s first year, 1998, the FDA got more than that amount on its drug alone. Pfizer knew what the drug was doing, but decided to choose money over ethics.

After disagreeing with the FDA’s request that “death” be cited as a side effect in Rimadyl, Pfizer eventually followed instructions. It was already too late. Vets were getting points that were redeemable for Palm Pilots, Zip drives and other prizes for selling the deadly product.

Maggie, a Chow mix, was on Rimadyl for four weeks. Her owner, Donna, got the pills with no information from the vet. In the four weeks that Maggie took Rimadyl, she vomited violently and vanished only to be found lying in a ditch. Upon Maggie’s death, Donna demanded that she know what took her dog. Liver toxicity. Donna took it upon herself to deliver letters to local vets about the ongoing problem with Rimadyl.

Although Pfizer had gotten many letters about the death drug they produce, it continues to sell and they continue to offer monetary damages to owners who have lost man’s best friend. Instead of using Rimadyl and risking your dog’s life, try glucosamine to treat your pet’s arthritis and keep your dog alive.

Pfizer to pay $1.3 billion criminal fine for misbranding its drugs

2009-10-19T12:34:00.000-07:00

http://www.NaturalNews.com/z027276_Pfizer_drugs_the_FDA.html

Pfizer to pay $1.3 billion criminal fine for misbranding its drugs
by Mike Adams, the Health Ranger, NaturalNews Editor

(NaturalNews) In the largest criminal fine ever levied against any drug company in the world, a unit of U.S.-based Pfizer, Inc. was sentenced to pay $1.3 billion in criminal fines and revenue forfeiture. It's all part of a $2.3 billion settlement announced by the Justice Department. The case centers around Pfizer's criminal "off-label marketing" of four drugs, including the painkiller Bextra. After whistleblowers filed lawsuits in three states, the U.S. Justice Department took an interest in the case and prosecuted Pfizer for criminal acts.

In the settlement, Pfizer admitted to a felony crime and agreed to pay $2.3 billion in fines and other fees. The investigation of Pfizer reportedly turned up evidence that Pfizer engaged in kickback payments to doctors for nine drugs, including Viagra and Lipitor.

Part of the reason the penalty against Pfizer was so large is because the company was considered a "repeat offender" in promoting drugs for unapproved uses (which is a violation of federal law).

Off-label marketing makes a mockery of modern medicine
So-called "off-label" marketing of drugs is rampant in the pharmaceutical industry. Although the FDA, drug companies and many conventional doctors claim the drug industry is guided by a "gold standard" of scientific scrutiny, the truth is that pharmaceuticals are routinely marketed and prescribed for health conditions for which they have never even been studied... much less actually approved by the FDA. The fact that this continues today makes a mockery of any "scientific credibility" the pharmaceutical industry claims to possess.

Drug companies take advantage of this gaping hole in regulatory oversight by getting their drugs approved by the FDA for one health condition, then heavily promoting it for numerous unrelated conditions. A drug approved for high blood pressure, for example, could be openly marketed for diabetes or Alzheimer's diseaseeven though there is no evidence whatsoever showing the drug to be either safe or effective for such conditions.

The same is true with the intended demographics of pharmaceuticals: Drug companies often get their drugs approved for adults, then they market those drugs to children even though the drugs have never been tested with children.

The result is a pharmaceutical industry that appears to be highly regulated, but isn't. Virtually any drug can be pushed for any disease for almost any reason -- all with virtually no oversight by the FDA. In fact, in this Pfizer case, even with the Justice Department filing criminal charges against Pfizer, the FDA has stood by and done absolutely nothing to prevent such actions from being repeated in the future by Pfizer or another drug company.