Bextra Lawsuits Filed in New York

Three Bextra Lawsuits Filed in New York
The Philadelphia lawfirm of Kline & Specter, has announced that they have filed three Bextra lawsuits against Pfizer Inc. on behalf of three individuals who allegedly were injured by the pain relief drug, Bextra. Two of the plaintiffs suffered heart attacks and one sustained a stroke after taking Bextra, attorneys for the plaintiffs stated.

Pfizer, the world's largest drug maker, suspended sales of Bextra in the United States and the European Union after the Food and Drug Administration concluded that its overall risk versus benefit profile is "unfavorable."

The Bextra lawsuits, filed in the Supreme Court of the State of New York on Friday, claim Pfizer failed to adequately and properly test Bextra, and failed to warn doctors, patients and others about its potential risks.

The plaintiffs in the Bextra lawsuits are Luis G. Flores, 33, of Texas, Jimmy Kitchen, 67, of Arkansas, and Theodis Maddox, Jr., 48, of Arkansas.

Many more Bextra lawsuits can be expected.

Law Change Would Help Vioxx and Bextra Sufferers

Proposal Could Aid Vioxx and Bextra Victims
(Salem Ore.)A bill expanding the number of people who can sue due to health problems caused by Vioxx and Bextra got its first hearing in the Senate Thursday. Prior to 2004 state law required that victioms must file lawsuits within two years of suffering an injury.

For many Vioxx and Bextra users, the statute of limitations ran out before the drugs were found to cause heart disease. This two year limitation unfairly restricted some patients' right to sue.

The bill, would change the deadline for filing lawsuits to two years after the cause of an injury is discovered. For Vioxx users, that would be Sept. 30, 2004, the date it was removed from the market.

Bill Limits Vioxx and Bextra Victims Ability to Sue
Mike Yukert testified for his wife, (who sat in a wheelchair beside him, cannot speak and is paralyzed on her right side because of the stroke he believes was caused by Vioxx.)"Imagine how frustrated you'd feel if, simply because you live in Oregon, that we cannot have our day in court," he said.

The law effectively blocks Yukert's wife from seeking damages because her stroke happened in 2002. No action has yet been taken by the Senate committee.

FDA Calls for Bextra Recall

Bextra to be Recalled - Warning Labels Added to Celebrex
The FDA has asked Pfizer Inc. to withdraw the painkiller drug, Bextra from the market. Pfizer and other manufacturers have also been asked to revise their labels to include boxed warnings of potential cardiovascular risks and gastrointestinal bleeding from certain arthritis drugs. What follows is the FDA's statement:

The FDA today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven K. Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."

FDA has asked Pfizer, Inc. to withdraw Bextra (valdexocib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.

In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.

These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.

To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.

Puerto Ricans Not Adequately Warned On Vioxx Dangers

According to the Consejo de Latinos Unidos (Council of United Latinos) Merck did not provide adequeate warning about the dangers of Vioxx.

"The tragedy in Puerto Rico is that many patients took the product without knowing the risks of heart attack or stroke," executive director K.B. Forbes said Thursday. The advocacy group presented a report on Vioxx in San Juan, Puerto Rico which said in part,

"Merck appears not to have adequately informed the public or medical community in Puerto Rico of the cardiovascular dangers of Vioxx, even after the (Food and Drug Administration) called on them to do so in late 2001."

Vioxx Warnings in English Only
"We believe that in 2002 Merck should have aggressively informed physicians and patients in Puerto Rico about the risks associated with Vioxx in Spanish- language materials," Forbes said. "This oversight, this possible negligence, may have also impacted other Hispanic strongholds in the United States."

New information was added to the Vioxx labels, but these new labels and doctor information were published in English in Puerto Rico. Spanish is the most common language spoken in the U.S. territory.

Related articles: Foreign Vioxx Lawsuits Continue to Grow and New Zealanders File Vioxx Lawsuits

Vioxx Danger Buried by Merck

The following article is published here with permission, was written by Mike Adams and was first published at News Target. The opinions expressed in the article are those of the author.

Merck caught in scandal to bury Vioxx heart attack risks, intimidate scientists and keep pushing dangerous drugs; Vioxx lawsuits now forming

The truth has finally come out about Vioxx: insider emails published by the Wall Street Journal reveal that Merck, the maker of Vioxx, was fully aware of the health risks of its COX-2 inhibitor anti-inflammatory drug as early as March, 2000. As is apparent from the published emails, there was a concerted effort to bury the negative evidence and even distort the drug trials by excluding heart patients from the Vioxx studies so that, "...the rate of cardiovascular problems for Vioxx patients would not be evident."

This has all been revealed now, thanks to the publication of Merck's own insider emails. One email, authored by Edward Scolnick, chief of research for Merck, says that cardiovascular risks, "...are clearly there." Additional emails contribute to the evidence that points to a fairly straightforward case of consumer deception.

Statements from several of these emails were recently published in a scathing article at the Wall Street Journal, which wrote, "Merck's first worry, in the mid-to-late 1990s, was that its drug would show greater heart risk than cheaper painkillers that were harsh on the stomach but were believed to reduce the risk of heart attacks. Several company officials discussed in e-mails how to design a study that would minimize the unflattering comparison, even while admitting to themselves that it would be difficult to conceal."

Even the medical journals are astonished at Merck's behavior. Dr. Richard Horton, editor of The Lancet (one of the most respected journals in the world), says, "the licensing of Vioxx and its continued use in the face of unambiguous evidence of harm have been public health catastrophes. This controversy will not end with the drug's withdrawal. Merck's likely litigation bill is put at between $10bn and $15bn. The company has seen its revenues and its capitalization slashed. It has been financially disabled and its reputation lies in ruins. It is not at all clear that Merck will survive this growing scandal."

Merck threatens scientists to suppress anti-Vioxx information

Merck has even been caught red-handed trying to suppress negative information about its drugs. Gurkirpal Singh, a Stanford University researcher, was threatened by the company and told he would "flame out" (meaning his career would be ended) unless he stopped giving "anti-Merck" lectures. This has now been revealed in a letter of complaint written to Merck by Dr. James Fries, a Stanford University Medical School professor, who went on to say, as reported in the Wall Street Journal, "There is a line that you can't go across. ... It had gone over that line."

And it wasn't just Stanford University, either: chief researchers at several top medical schools were being threatened by Merck. Dr. James Fries called it, "a consistent pattern of intimidation of investigators by Merck."

Merck's Chief Executive Raymond Gilmartin, in response, says it the firm has "a deep and abiding commitment to the highest ethical standards in all our dealings with physicians and other healthcare providers." Sure it does. And Vioxx is good for you, too.

As if all this wasn't enough, a Merck training manual was developed and distributed to help company officials fend off criticisms about Vioxx and instill pro-Vioxx propaganda in the minds of doctors. The document listed questions about the safety of Vioxx and said in capital letters, "DODGE!" Internally, it was even called the "Dodge Ball Vioxx" document. The primary purpose of the document was to convince doctors to keep prescribing Vioxx, even while evidence of the drug's dangers mounted.

Classic Big Pharma behavior

What does all this add up to? It's Big Pharma as usual, folks: distorted clinical studies, lying to consumers, threatening critics, burying negative evidence and all the while heavily promoting the drug to physicians and consumers. This is exactly what I've been talking about all along. These companies are knowingly harming patients just so they can keep selling dangerous drugs to a population that's generally too uninformed to know any better. And most conventional physicians just kept on prescribing the drug, oblivious to the true causes of disease or health.

Given all the damning evidence about Vioxx and its handling by Merck, does the company apologize and try to make amends? Of course not. Merck said in a recent news release that it "acted responsibly and appropriately as it developed and marketed Vioxx."

See, it's not just that these pharmaceutical companies act with reckless endangerment to the public, it's also the stunning fact that they don't see anything wrong with it. They will develop a dangerous drug, distort the clinical trials, lean on the FDA for approval, threaten scientists who speak out against the drug, and finally when the body bags start mounting, they'll claim they are innocent and have been acting ethically and honestly all along.

Dangerous drugs still generate profits

Yet the pattern of exploiting the public for profit is quite clear. An email authored by Dr. Scolnick, Merck's research chief, during the development of Vioxx reveals that even though the drug was known to be dangerous, it was bound to be a great seller just like the company's other drugs which, he admitted, are also dangerous: "We have a great drug and like angioedema with vasotec and seizures with primaxin and myopathy with mevacor there is always a hazard. The class will do well and so will we."

By saying, "The class will do well and so will we," he clearly means that despite the health hazards of the drugs, they're going to sell well anyway, and everyone who owns stock at Merck (or who works at Merck) is going to financial benefit from that.

Even prestigious medical journals (which are funded primarily by drug advertising money, by the way), joined in pumping up the credibility of Vioxx. In November, 2000, the New England Journal of Medicine published an article written by academics who were literally paid by Merck. This article heralded the "benefits" of Vioxx in reducing stomach problems and -- get this -- reducing heart attack rates. The article, of course, left out all the negative information about Vioxx, including what was obvious even in 2000: that Vioxx increased the risk of heart attacks, strokes and blood clots, even in healthy people.

The FDA: asleep at the wheel

For its part, the FDA does nothing to protect consumers. As always, the agency ignored the dangers of prescription drugs and, for many years, continued to allow Merck to keep pushing this dangerous drug right up to the day the evidence was undeniable and the drug was finally pulled. The behavior of the FDA was so irresponsible (if not downright criminal) that it earned itself scathing criticism from The Lancet, where Dr. Horton explained, "This discovery points to astonishing failures in Merck's internal systems of post-marketing surveillance, as well as to lethal weaknesses in the U.S. Food and Drug Administration's regulatory oversight." (Emphasis added.) This phrase, "lethal weaknesses," has never before been used to describe the FDA... at least not by anybody in the medical industry. It means, simply stated, that the FDA's mistakes are killing people.

In effect, the FDA acted as a Big Pharma propaganda machine, catering to the interests of drug companies at every turn. In 2001, when the FDA became increasingly aware of the dangers of the drug, it went to Merck and asked the company to include prominent new warnings on the drug label. Merck balked and complained that the FDA should, instead, highlight the drug's positive gastrointestinal features. Instead of demanding the inclusion of the warning label (like a fully empowered regulatory body might do), the FDA caved in and actually reached a compromise with Merck that resulted in a new label promoting the claim that Vioxx would caused fewer stomach upsets! Below that claim, in small print, it mentioned that the drug would also cause more heart attacks and strokes.

Meanwhile, people were dying. How many people were harmed or killed in those four years during which Merck and the FDA hid the truth about Vioxx? And how many other drugs are just as dangerous and yet heavily promoted? According to the American Medical Association, prescription drugs kill -- yes, kill -- 100,000 Americans each year. Another document, Death by Medicine authored in part by Dr. Gary Null, shows as many as 750,000 people being killed each year by medications and surgical procedures combined. Clearly, these deaths dwarf the fatalities caused by terrorists, wars, and all national crime statistics combined.

Drug companies far more dangerous than terrorists

It leads to a startling, but true, conclusion: drug companies are killing far more Americans than all terrorists, murderers and criminals combined, and yet the deaths are allowed to go on thanks to a Bush Administration that's closely allied with Big Pharma and a Food and Drug Administration that might as well be called the "Drug Promotion Agency."

"the FDA continues to see the pharmaceutical industry as its customer -- a vital source of funding for its activities -- and not as a sector of society in need of strong regulation." - Dr. Richard Horton, editor, The Lancet

Outraged

I'm outraged by this. I'm outraged by the pain, suffering and fatalities that are caused every day by prescription drugs. I'm outraged by the behavior of the FDA and its campaign to discredit herbs and vitamins while ignoring far more dangerous prescription drugs. I'm outraged by the drug company executives who earn millions of dollars each year peddling dangerous drugs to elderly people who have to choose between food and medicine because they can't afford the sky-high prices of prescription drugs. I'm outraged by the FDA's efforts to monopolize the U.S. drug market, ban drug imports from Canada, and force senior citizens to pay ridiculous prices for deadly drugs. And I'm outraged by a national media that's so tied to drug company advertising revenues that we'll probably never be able to repeal direct-to-consumer advertising (which is partly responsible for this Vioxx mess).

It's time for serious action. It's time to go after these criminal pharmaceutical executives and charge them with the crimes they have committed against humanity. It's time to hit these companies where it hurts: right in the pocketbook. It's time to put Merck and its competition out of business for good... and thereby save the lives of untold Americans who can be spared the harm caused by prescription drugs.

And here's how I'm going to help make that happen:

For the first time ever, I am publicly supporting legal action against a pharmaceutical company. Today, I am announcing that I will assist individuals who were harmed by Vioxx in filing lawsuits against Merck for the damage caused by their products. I'll do this by getting you in touch with capable legal teams who are involved in ongoing legal action against the pharmaceutical giant. So if you've taken Vioxx and want to join what could become a multi-billion-dollar settlement against Merck, contact us at feedback48@newstarget.com and include your name and address. We'll forward your information to a legal team who will take it from there. (We're doing this at no charge, and without any financial compensation of any kind.)

Or, you can search on Google or some other search engine and find a legal team yourself. Whatever you do, don't sit back. This is not just about getting a financial reward for yourself, this is about bankrupting an evil empire that is knowingly damaging the health of millions of people in order to make a buck. And these "smoking gun" emails are probably just the tip of the iceberg. Who knows how many more evils are taking place behind closed doors at Merck and other companies, where the business philosophy seems to be, "profits at all costs!" Ethics be damned. These companies are going to sell you drugs that may, indeed, kill you. And they're going to keep raising the prices each year, too, so you have to pay more even while you continue to be harmed. It is unethical, unjust, and unacceptable.

It's time to stand up and take action. If you've been harmed by Vioxx, I urge you to demand justice and join the legal action against Merck. Let's put this company out of business for good and send a message to Big Pharma that they can no longer exploit Americans' health for their own corporate greed.

Related information: How to Select a Vioxx Attorney

FDA Panel Biased in Vioxx, Celebrex and Bextra Decisions?

An FDA panel of scientists and doctors recently voted to keep Celebrex and Bextra on the market and to allow for a possible return to the market for Vioxx. The FDA typically follows recommendations of its advisory panels and these decisions were widely seen as a victory for both Merck and Pfizer.

With Vioxx and Celebrex lawsuits increasing daily, both Merck and Pfizer were looking for any edge they could get. The fact that the FDA panel did not remove the products from the market and in fact voted to return Vioxx to the market meant that lawyers could point to the panel decision and say, "The FDA didn't find a serious problem here - these products must be OK!" Attorneys for Merck and Pfizer were elated with the decisions. Attorneys for Vioxx and Celebrex plaintiffs were troubled. Their lawsuits just became more difficult to win.

However, as is usually the case when discussing lawsuits that involve huge sums of money, not everything is quite as simple as it appears. The New York Times asked the Center for Science in the Public Interest to look into the panel to see if there were any conflicts of interest. The results of the research showed that 10 of the 32 panel members were paid consultants for either Pfizer or Merck. Further analysis showed that if those 10 panelists had not voted, the committee would have rejected future sales of Bextra and Vioxx.

"Votes are tainted", Sen. Charles Grassley
"Unfortunately, the votes ... are now, justly or unjustly, tainted," said Iowa Republican Sen. Charles Grassley, chairman of the Senate Finance Committee.

With this information now out in the open, what had appeared as a victory for Merck and Pfizer, is a hollow victory at best. If they try to use the decision of the FDA panel in court, the plaintiff lawyers will point out the there was a clear conflict of interest and that the findings of the panel have no merit.

The FDA had been looked upon as a source of information. Information that could make or break the pending Vioxx, Celebrex and Bextra lawsuits. Unfortunately, once again, the FDA was not up to the task.

Related story: Vioxx Inquiry Panel Biased?

More Vioxx News: Conflict of Interest on COX-2 Panel

The Vioxx Saga - A Daughters Concern

The following is a thought provoking letter written to Elites TV, who have been kind enough to allow it to be re-published here. This is not the kind of article that you usually find on this site. It is not about Vioxx lawyers or class action lawsuits. It's about someone that wanted to help out, someone that wanted to do the right thing and the consequences of that decision.

***

"Last year, my 80-year-old mother underwent knee replacement surgery. She was in otherwise good health, and decided to have the surgery to improve the quality of her life. The old knee had made walking difficult, and her doctor assured her that a replacement would give her back the ability to walk and exercise with much less pain and effort.

The surgery was successful, and after a few days in the hospital, she was released to a rehabilitation center where she was to stay for a week to receive some therapy. She is a determined woman and wanted to get back on her feet, literally.

But things didn't quite go as planned. A few days into her stay, she began complaining of pain in the knee and noticed some swelling. Medical personnel assured her that this was normal, but as the swelling and pain increased, she knew instinctively that something was wrong.

Finally, a doctor was called in to look at her knee and realized that this swelling was not routine. She was rushed back to the hospital where doctors confirmed that she had developed a blood clot, which had it dislodged, would have most likely had dire effects, and might even have killed her.

She was confined to bed rest, given blood thinners and her recovery was set back two weeks. Once she was released, she had to endure more therapy but the knee had already set up and even now, a year later, she is still not able to use it normally.

Why did this happen? The doctors had no answers, but when her history was studied, they determined that it may have been due to her participating in a drug trial several years prior. She had been in a test group for Vioxx, but never learned whether she had been given the drug or a placebo. Those records weren't available but, considering what has been learned about this drug since, it is not a stretch to think that this was the case.

How many people participate in trials without knowing the drug that they were given? If those people ultimately suffer side effects, do they have any recourse? This is an area that has received little publicity but certainly opens up a new area of discussion. At the least, potential subjects might want to think twice before taking part in such a study.

It is understandable that patients might want to be part of a study. Arthritis sufferers will go to any lengths to find relief, even if for a short time. And certainly, these drugs are effective. But at what cost?

My mother has had to give up taking any kind of arthritis pain medication for over a year and continues to take blood thinners to prevent clots. She can't even go to the dentist for fear of bleeding. This vital woman who thought she was going to be improving the quality of her life is now angry and discouraged, and still in pain. There is no recourse, but she hopes that her experience can alert others to at least ask the hard questions when participating in these trials. Understandably, she is reluctant to have the other knee done and is willing to live with the pain rather than risk death.

In an age where people are suing for being injured by coffee that is too hot, one wonders how these companies protect themselves from litigation during these trials. Participants sign lots of forms, acknowledging their risk and signing away their rights to sue. But, for a daughter who loves her mother, no amount of money could have compensated for the loss of her mother, if the worst had happened. Thankfully, she survived this. But how many do not, and is it worth it?"
D.R. Boyer

Re-published with the permission of Elites TV

Celebrex and Bextra Warnings Issued in Germany and New Zealand

Celebrex and Bextra Dangers Prompt New Warnings
The New Zealand Ministry of Health has issued a strong warning related to the Cox-2 painkillers Celebrex, Bextra and Arcoxia. It says the increased risk of heart attack and stroke outweighs the benefits.

Ministry spokesman Dr Stewart Jessamine says they do not have enough information yet to quantify the risk, but their preliminary conclusion is that all Cox-2 inhibitors may increase the risk in some patients.

In Germany, the regulatory body BfArM announced that patients who either have had a heart attack or stroke, suffer from circulatory disorders of the heart or are at a high risk of developing such conditions should no longer use the medications. They have announced that they will introduce new restrictions covering the use of COX-2 inhibitors, such as Pfizer's Bextra and Celebrex and Merck & Co's Arcoxia.

In the new product guidelines, it will be pointed out that the use of COX-2 medications should be limited to the lowest effective dosage and for only so long as is absolutely necessary.

Related story: FDA Votes to Keep Vioxx, Celebrex and Bextra on the Market

FDA Votes to Keep Vioxx, Celebrex and Bextra on the Market

Celebrex and Bextra Stay - Vioxx may Return
This past week, a special panel of 32 scientists was assembled by the FDA to examin the safety of the COX-2 drugs Vioxx, Celebrex and Bextra. After hearing testimony from many witnesses including doctors, scientists and drug manufacturers, the panel voted to allow Celebrex and Bextra to remain on the market. They also made provision for Vioxx to be returned to the market. (Vioxx was recalled in September, 2004)

All three of these drugs have been linked in various studies with patients suffering serious heart complications including heart attacks and strokes. The move to allow these drugs to remain on the market was not without controversy.

Consumer advocate Sidney Wolfe of Public Citizen said, "This was a very bad decision," and added that Vioxx's effectiveness "is swamped by the dangers."

Alistair J. J. Wood of Vanderbilt University, a pharmacology professor who chaired the joint meeting, said, "The data are very compelling. Vioxx is substantially worse than the others."

On the positive side, Pennsylvania epidemiologist John T. Farrar, said, "The absolute increase in risk is not such that these drugs should be pulled out of the hands of wise physicians and informed patients as though there is a smoking gun."

Warning Labels on Celebrex and Bextra
The panel also recommended several measures designed to increase patient and doctor awareness of the dangers of the drugs.

Their suggestions included placing a prominent "black box" warning on the drugs' packaging, including more patient information, restricting which patients could get them, and banning direct to consumer advertising.

Related Story: Doctors in Pain over Vioxx

Drug Oversight Safety Board Created

One day before the FDA begins it's investigation into the COX-2 drugs, Vioxx, Celebrex and Bextra the creation of a new independent monitoring board within the FDA has been announced. The Drug Oversight Safety Board, is being formed and will be comprised of experts from the FDA, research groups, patients and consumer advocates. The board will recommend what information and updates to put on the government's Drug Watch, resolve disputes over drug safety issues, and oversee the development of a drug safety policy.

"The public has spoken and they want more oversight and openness," said Health and Human Services Secretary Mike Leavitt on Tuesday. "They want to know what we know, what we do with the information and why we do it."

Safety Board Designed to Eliminate Vioxx Type Problems
Sen. Charles Grassley, (D-Iowa) said, "It also remains necessary that the drug safety office within the FDA be made a truly independent entity from the office of new drugs. I'm drafting legislation to clearly establish this independence and provide the office the authority needed to do its job."

"The steps announced today ... are an overdue step forward, but they don't go nearly far enough. It is critical that FDA's resources to monitor drugs be dramatically increased, and the FDA must be given the authority to require drug companies to initiate and complete appropriate safety studies," said Sen. Edward Kennedy, a critic of the Bush administration's handling of the FDA.

Related story: FDA to Probe Vioxx, Celebrex and Bextra

Vioxx Bombshell to be Revealed to FDA

A News Advisory from the Pysicians Committee for Responsible Medicine, states that John J. Pippin, M.D., FA.C.C will testify Thursday before the FDA and "present a new report detailing how experiments on mice, dogs, and other animals misled scientists and ultimately contributed to a tragic outcome for human patients exposed to Vioxx and other drugs."

The report further states, "PCRM's report reveals that Vioxx and other COX-2 drugs actually had a heart-protective effect in mice and other animals, exactly opposite of how the drugs later performed in humans. The report also reveals that once clinical trials started showing that the drugs caused heart problems in humans, the pharmaceutical companies ignored this information and instead pointed to the animal tests as "evidence" that the drugs were safe. As Dr. Pippin illustrates in the report, the Vioxx animal testing debacle is not unique. Over the years, millions of patients have been exposed to harmful drugs, such as Rezulin and Baycol, that seemed safe in tests on mice, dogs, rats, monkeys, horses, and other animals.

"Reliance on animal tests enabled the FDA to approve Vioxx," says Dr. Pippin. "It is time to turn to newer, more reliable human-based methods such as studying drug metabolism using human liver subcellular fractions." Liver toxicity is the major reason for drug re-labeling and withdrawal, and it often does not show up in dogs and other animals.

In three days of hearings, beginning this Wednesday, the FDA and a panel of outside experts will investigate the safety of arthritis drugs called Cox-2 inhibitors. This group includes Vioxx, Celebrex, and Bextra.

Related story: FDA to Probe Vioxx, Celebrex and Bextra
Contact: Jeanne Stuart McVey of the Physicians Committee for Responsible Medicine, 202-686-2210, ext. 316 or 415-509-1833 (cell), jeannem@pcrm.org

Australia Places Warning Labels on Celebrex, Bextra

According to an article by Rita Rubin, in USA Today, Australia's Therapeutic Goods Administration has ordered the makers of COX-2 drugs (including Celebrex, Bextra) to place a boxed warning on their labels, advising patients about the increased risk of cardiovascular problems. The agency is further advising patients who take more than 200 milligrams a day of Celebrex to discuss their treatment regimen with their doctor.

Bextra May Not be Approved
The Australian agency also has proposed withdrawing its approval of Bextra for the treatment of arthritis. Bextra has not yet been approved for use in Australia.

In other news, results of a study that "pooled the results of 19 trials comparing COX-2 inhibitors with a placebo or conventional pain reliever, such as ibuprofen or naproxen", showed that Vioxx raised blood pressure more than Celebrex. This increase in blood pressure "requires caution in their use and warrants further investigation," the authors write.

For the complete story: Australia puts Warning Labels on Celebrex and Bextra
Related story: FDA to Probe Celebrex and Bextra

Will Celebrex and Bextra be Recalled?

Future of Celebrex, Bextra to be Decided at FDA Meeting
The fate of an entire class of drugs (COX-2 drugs, Celebrex, Bextra) is likely to be decided at a meeting of the FDA's Drug Safety & Risk Management Advisory Committee this week.

The COX-2 drugs, Vioxx, Celebrex and Bextra were developed to be effective painkillers that did not cause bleeding, stomach ulcers and other serious digestive tract complications. Older nonsteroidal anti-inflammatory drugs such as ibuprofen killed the pain but often were the cause of intestinal problems.

Aggressive marketing to physicians and "direct to patient' advertising made Vioxx, Celebrex (and Bextra to a lesser degree) huge successes. Unfortunately, the COX-2 inhibitors have never been shown to be more effective than conventional NSAIDs and reports of serious heart complications associated with Vioxx, forced it's recall. More reports of side effects associated with Celebrex and Bextra have prompted this three day meeting of the FDA Arthritis Drugs Advisory Committee.

Chief of rheumatology at Presbyterian Hospital of Dallas and Arthritis Advisory Committee member John Cush, says he's hoping that "some appropriate and proper guidance comes out of this." Patients and doctors everywhere agree.

Related article: Study May Speed Recall of Celebrex and FDA Probes Celebrex, Bextra

Major University Advises Patients to Avoid Celebrex, Bextra

An article in the Opelica-Auburn News by Jack Stripling says that Auburn University’s Pharmaceutical Care Center has advised patients to avoid taking the controversial medications Vioxx, Celebrex and Bextra.

Since the Vioxx recall, questions are being raised about the safety of two other drugs - Bextra and Celebrex - part of the COX-2 family of medications.

Are Vioxx, Celebrex and Bextra All the Same?
"We might find that all COX-2 inhibitors have the same risk,” said Dr. Kimberly Braxton Lloyd, director of AUPCC.

Vioxx, Celebrex and Bextra were developed to deliver pain relief like aspirin and ibuprofen but without the nasty side effects of gastrointestinal bleeding. But according to a newsletter published by the AUPCC, "drug manufacturers tweaked the drugs to reduce stomach pain, but in so doing inhibited a chemical in the body that promotes blood flow. The result? Blood vessels narrow and platelets clump which increases the risk of heart attacks and strokes."

The article goes on to say that a bad situation was made worse by all the 'direct to consumer' advertising. "The negative side of it is you may have people coming in and asking for medications that aren’t appropriate for their conditions,” said Dr. Kem Krueger, associate professor in AU’s School of Pharmacy.

“The FDA was not quick enough to act on this potential problem or to identify it,” Krueger said. “I don’t know if it’s shaken confidence to the core,” he added. “But it’s made us question.”

For the complete story: Patients Should Avoid Celebrex, Bextra

Can Vioxx Problem Force Bankrupcy?

Vioxx Class Action Suits Increase Pressure on Merck
When Merck CEO, Raymond Gilmartin was asked if Vioxx litigation would bankrupt the huge drug maker, his answer was, "Absolutely not, anyone who looks at the strength of our balance sheet and our cash flow will see that."

However, some financial analysts feel differently, for these reasons:

*** Vioxx litigation costs will be high. An estimated 700 Vioxx lawsuits have been filed and more are expected. The number of actual Vioxx class action plaintiffs is now estimated in the tens of thousands.

*** Merck's Vioxx liabilities are potentially very high. Depending on the actual number of plaintiffs and the number of class action suits that are won by plaintiffs, estimates of Vioxx liabilities range from $18 billion to over $50 billion.

*** Merck has made no provisions whatsoever for its Vioxx liabilities. Management at Merck apparently believes that class action and individual settlements can be drawn out for an extended period of time. This may allow them to pay out damage awards from future cash flow.

Vioxx Litigation may Cost Billions

There is one thing that may save Merck and several other pharmaceutical giants including Pfizer Inc. (Celebrex, Bextra) and that is President Bush. Bush is promoting a piece of legislation, that if it becomes law, would restrict a citizens right to sue and would limit the amount off damages paid. The drug companies contributed huge sums of money to the Republican party in the last election. There are many that believe the president is running the best government that money can buy. Don't bet on Bush siding with the rights of the individual ahead of the needs of corporate America.

Related Articles: Vioxx, Celebrex Users Lose Rights and Bush Protects Makers of Vioxx, Celebrex

Vioxx, Celebrex Safety Concerns

Vioxx, Celebrex and Bextra Alternatives Sought
When Vioxx was recalled from the market in September of 2004 many patients throughout the U.S.A. and worldwide went looking for a new painkiller. Some of them were advised by their doctors to return to the old standbys, Aspirin, Advil or Tylenol. But many switched to the other COX-2 drugs, Celebrex and Bextra.

Now, with recent studies being made public, questions are being asked about the safety of Celebrex and Bextra. The FDA will hold an unprecedented three day inquiry into the dangers of Celebrex and Bextra. All advertising for Celebrex has been halted.

The many people suffering and in pain must find a safe solution, but medications once thought to be safe are suddenly unavailable. So, what choices do you have?

Speak to your doctor. Get your doctor to explain the pros and cons of the individual medications so that you understand all the risks associated with using these painkilling drugs. Ask questions like:

** What painkilling drug are you recommending?
** How long has the drug been on the market?
** What particular problems are associated with the drug?
** What side effects have been reported?
** What side effects have you seen personally?
** How much experience do you have prescribing this drug?

Unfortunately, being confused about which drugs are safe is a rather normal state these days. Many people feel that the FDA has let them down and now the Bush government wants to limit damage suits against the pharmaceutical companies. Bookmark this page and return often. We will keep you up-to-date with all the latest information. Being informed is your best option.

Related article: Celebrex Risk

Pfizer Defends Celebrex

Pfizer Refutes Celebrex Claims by Public Citizen
Responding to another petition for the recall of Celebrex by the consumer group Public Citizen on Monday, officials at Pfizer issued a press release today.

Pfizer vigorously refutes claims by Public Citizen that safety data from a 1999 Celebrex study in Alzheimer's patients were "undisclosed." The study was monitored by an independent panel of safety experts, an abstract of the results was presented at a scientific congress in 2000, and the completed study report was submitted to the FDA in June 2001.

"Pfizer acted responsibly in sharing this information in a timely manner with the FDA," said Dr. Joseph Feczko, Pfizer president of worldwide development.

"Public Citizen’s cherry-picking of data is alarmist and misconceived,” he said. “It is not possible to draw clinically meaningful cardiovascular conclusions from this study alone given the variations in patients’ medical history, their advanced age and other significant study limitations. This flawed use of data is misleading and unfair to a reasoned scientific discussion of these issues.”

The release further states that there was a large difference in the "underlying cardiovascular risk profile of the patients assigned to Celebrex treatment compared with those who received placebo." and that "Even Public Citizen acknowledged the study "was not large enough to demonstrate a statistically significant increase in any individual serious cardiovascular event."

The release concludes by stating that "the upcoming FDA advisory meeting is the appropriate forum for these important public health issues to be fully addressed and put into context.”

Full press release: Pfizer Defends Celebrex

Canadian Study Finds No Heart Risk with Celebrex

Increases in Heart Risk with Vioxx but not Celebrex

A major study done at Canada's McGill University in Montreal has concluded that patients taking Vioxx were at incresed risk of heart attack and stroke. The study included 113,927 older residents of Quebec and found incidence of heart attacks increased 21 percent among those who took low doses of Vioxx and by 73 percent in those who took high doses.

"This is consistent with what most of the other studies have found," said study author Dr. James A. Brophy, an associate professor of medicine at McGill. "But it included many more cases than other studies, so we were able to have more precision. And other studies have not demonstrated dose-dependency."

Increased Risk Not Found with Celebrex
Another interesting conclusion from this study is that no similar increase in risk was found for Celebrex. Celebrex, like the recalled Vioxx is a member of the cox-2 inhibitor family of drugs.

"The importance of the new study is that it separates Vioxx from other cox-2 inhibitors," said Dr. Todd Schlifstein, an assistant professor of rehabilitation medicine at New York University School of Medicine. He called it "an impressive study because of its vast size and the number of years over which it was done."

Study results appear in the Feb. 1 online edition of the Annals of Internal Medicine.
Related story: FDA to Probe Celebrex, Bextra

Bextra Banned by Kaiser Permanente

Could Celebrex be Next?

The controversial COX-2 drug Bextra has been banned by one of the nation's largest managed care organizations. In a move that is unprecedented, Bextra has become the first drug approved by the Food and Drug Administration to be banned by Kaiser Permanente.

Dr. Sharon Levine, associate executive director of the company's Northern California unit said that Kaiser physicians had already avoided using the drug. But "for safety and quality reasons, we don't want to be involved in dispensing this drug," she said.

Dr. David Campen, Kaiser's medical director of pharmacy services, said yesterday, Kaiser doctors will continue prescribing Celebrex. At low doses, "Celebrex does not appear to have the same risks as Bextra or Vioxx", Dr. Campen said.

"But clearly at the higher dose levels, there does seem to be a problem" with Celebrex, he said.

Both Celebrex and Bextra offer no unique benefits but plenty of possible risks. Clinical trials have found that Celebrex and Bextra cure pain no better than older medicines like ibuprofen and claims that they are safer on the stomach than older medicines have never been proven.

Related story: FDA Probes Celebrex and Bextra Safety

SEC to Investigate Vioxx Withdrawl

In a press release issued today, Merck and Co. announced that notification has been recieved from the Securities and Exchange Commission that there would be a formal investigation into the Vioxx problem.

It is believed that the inquiry will center around whether Merck disclosed enough information about Vioxx. News of the SEC inquiry sent Merck shares falling again, this time by $2.53, or 8 percent, to $28.65 after falling as low as $28.32.

The Merck press release says that the SEC move 'wasn't unexpected', and notes that a formal probe gives the SEC staff the power to issue subpoenas for documents or testimony. Merck is also being probed at this time by the Department of Justice and certain Congressional committees.

Vioxx Problem Multiplies for Merck

Food and Drug Administration safety reviewer David Graham said in a study published this week by the U.K. medical journal Lancet that Vioxx may have caused as many as 140,000 heart attacks in the U.S. The Vioxx problem could become the single largest product safety lawsuit in history, with some estimates putting the number of plaintiffs in the tens of thousands.

Related story: European Agency to Probe Vioxx Problem