Vioxx, Bextra recall mean new pain relief options needed

Over the past few months, millions of American arthritis sufferers have been forced to find alternatives to medication for their pain to avoid potentially deadly side effects. Soon after prescription medications Vioxx and Bextra were taken off the market for their potential cardiovascular and gastrointestinal health risks, the Food and Drug Administration (FDA) warned of similar risks associated with popular over-the-counter (OTC) pain relievers. Despite these developments, arthritis sufferers can achieve pain relief by adapting simple lifestyle changes into their daily routines. (Related links: Vioxx recall and Bextra recall)

This is a frustrating time for arthritis patients. After learning about the potential outcome of taking various pain relieving medications, many patients are left searching for a safe yet effective means of relieving their condition. However, I've seen first-hand that non-surgical and natural approaches to pain relief can be very successful. Sufferers should know that medication is not the only option.

Exercise

Everyone needs to exercise, but not all exercises are appropriate for those afflicted with arthritis. It is important to engage in exercises that will strengthen the muscle, but not irritate the joint. For example, walking is an excellent exercise for arthritis sufferers. However, if a patient's knees become sore with walking; bicycling, arm exercises or walking in a pool can also be beneficial.

Balance exercises

Tai Chi and water aerobics are types of balance exercises that can be effective without adding much pressure to joints. But, take it easy. If joints hurt after exercising, they were probably overexerted. If the pain persists over the next few days, a physician should be consulted.

Weight control

Every ten pounds of weight gained is equal to 30 pounds of pressure on the knees. Thus, losing ten pounds is the same as removing 30 pounds of pressure on a patient's knees.

Heat/cold

Using ice packs can reduce acute pain while heat loosens joints and increases blood flow. Try sitting in a whirlpool before exercising and icing an irritated spot after exercising to provide soothing relief.

Attitude/education

It is important to have a positive attitude when living with arthritis. In addition, sufferers should educate themselves as much as possible regarding their condition. Learn about new developments, read up-to-date materials and ask questions of health experts or a personal physician.

Assistive devices

Anything that makes completing a daily task easier is considered an assistive device. These devices can help to reduce discomfort and disability. In addition, they can also help people with arthritis become more functional by reducing their dependence upon others. For example, the Foot Funnel, a modern day type of shoe horn, is an assistive device, is recommended for those patients who have difficulty putting on their shoes. Other helpful examples include cervical pillows, custom-made foot orthotics and canes.

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Vioxx recall lawsuits drama begins in Cheryl Rogers case

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Bextra recall is no gain for Celebrex yet

Dr. Keith Reich is a contributing editor at OurHealthNetwork.

Vioxx recall lawsuit drama begins in Cheryl Rogers case

As expected, the drama in Vioxx lawsuits is getting ugly. Merck, a company that appears to come across as desperate in its behavior so far, started the media war first by accusing plaintiff Cheryl Rogers of being a liar. She is the widow of a man who died after taking Vioxx and her case is the first one to go on trial next month. While it has no technical implications on how other lawsuits turn out, if Merck wins this lawsuit, it may get a boost in its argument that Vioxx did not kill anyone despite repeated findings that Vioxx has injured as many as 140,000 Americans. (Related article: Vioxx recall lawsuits update)

Now Mrs. Rogers' attorney is hitting back. In a motion filed recently, the attorneys are demanding sanctions against Merck for violating a protective order and disclosing personal and confidential information to the news media related to Cheryl Rogers and her deceased husband, Howard Rogers. According to attorney Jere Beasley, whose firm Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Alabama, represents Ms. Rogers: "Merck provided depositions of Mrs. Rogers and Dr. William Clancy, who treated her husband, to local and national press on April 12, in violation of the court's protective order. In fact, one reporter had the documents on this date apparently before it was even filed in court." In addition, the motion cites Merck being in violation of the provisions of HIPAA by disclosing personal medical information pertaining to Howard Brad Rogers. (Related article: Merck continues its attack on Vioxx victims)

Mr. Beasley's motion on behalf of Mrs. Rogers requests that the court vacate its protective order as it relates to documents produced by Merck. He is asking the court to allow for public disclosure by plaintiffs' attorneys of all Merck documents. In a recent disclosure by the New York Times, it has been clearly shown that as early as 2000, Merck knew that Vioxx was killing people but it decided to suppress the evidence so that sales would not be impacted. (Related article: Merck and Pfizer ignored drug safety; focused on profits alone)

In another study, dubbed the Advantage trial (completed in 2000), eight people taking Vioxx suffered heart attacks or sudden cardiac death, compared with just one taking naproxen (Aleve), according to data released by the F.D.A. earlier this year. The difference was statistically significant, but Merck never disclosed the data that way. "Merck intentionally misled the public and the medical community by withholding information relating to known dangers associated with taking Vioxx," Beasley says.

"Releasing Merck's documents would serve the public interest by exposing its wrongful conduct over the years," Beasley adds. "Clinical tests have proven Vioxx is and was a dangerous drug. It has killed literally thousands of unsuspecting victims who trusted the company and who had no idea that Vioxx caused heart attacks and strokes."

Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. has been in the forefront of the effort to have all of the cyclooxygenase-2 (COX-2) inhibitors (Bextra, Celebrex and Vioxx) taken off the market since the law firm took on its first case against Merck more than four years ago. Beasley Allen is spearheading the review of over 31,000 claims against the manufacturers of Bextra, Celebrex, and Vioxx, having filed 161 cases to date. In another bizarre turn to the events leading up to the trial, the law firm has also donated campaign contributions to the judge who is presiding over the trial.

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Merck hid risk of death from Vioxx

While Merck continues to deny any wrongdoing in personal injuries inflicted on 140,000 Americans from Vioxx and countless many in other countries (estimates not available), it is now becoming clear that Merck may have known as early as 2000 that Vioxx was killing people. Rather than doing something about it, Merck continued to market the drug aggressively to people who were least likely to be benefit and were most likely to be hurt by it. Merck did not announce a Vioxx recall until September 30, 2004.

According to The New York Times, when Merck scientists established a relationship between Vioxx and death of a woman, the company listed the cause of death as "unknown" in reports submitted to the FDA and in published studies. The newspaper now has evidence (internal Merck emails) provided to it by a Vioxx attorney and this evidence will be presented in courts.

Not only does Merck continue to deny that Vioxx killed arthritis patients, it has been aggressively attacking Vioxx victims, including accusing them of lying. But this disclosure actually proves that it was Merck that was hiding the facts. Such evidence will prove critical in Vioxx class action lawsuits scheduled for trial in coming months. It is expected that Merck's Vioxx liabilities could be as much as $38 billion and Vioxx litigation may force the firm into bankruptcy.

Since the recall of Vioxx, Merck continues to suffer financially. After Bextra recall, Merck's competitor Pfizer is also hurting financially. The only Cox-2 drug that remains on the market is Celebrex which now carries a black box warning. There have been repeated calls for a Celebrex recall due to safety concerns.

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Vioxx recall lawsuits update by Merck

Since a Vioxx recall was announced on September 30, 2004, Merck has been bombarded with lawsuits from victims all over the world. The liabilities from Vioxx threaten Merck's survival as it continues to suffer from the impact of the drug recall. The company refuses to formally account for any potential liabilities. If it were to do so, its financial situation will look even worse. As part of its quarterly financial update, Merck & Company provided the following Vioxx litigation update:

Vioxx litigation update from Merck

As previously disclosed, individual and putative class actions have been filed against the Company in state and federal courts alleging personal injury and/or economic loss with respect to the purchase or use of VIOXX. A number of these actions are coordinated in proceedings in a multidistrict litigation in the U.S. District Court for the Eastern District of Louisiana, New Jersey state court, and California state court. As of March 31, the Company has been served or is aware that it has been named as a defendant in approximately 2,300 lawsuits, which include approximately 4,600 plaintiff groups alleging personal injuries resulting from the use of VIOXX, and in approximately 225 putative class actions alleging personal injuries and/or economic loss (all of the actions discussed in this paragraph are collectively referred to as the "VIOXX Product Liability Lawsuits"). (Related article: Tens of thousands of plaintiffs expected in Vioxx lawsuits)

Also as previously disclosed, there are putative class actions against the Company and various current and former officers and directors asserting claims under the federal securities laws (the "VIOXX Securities Lawsuits") and under the Employee Retirement Income Security Act (the "VIOXX ERISA Lawsuits"), as well as shareholder derivative lawsuits asserting breaches of fiduciary duty under state corporation law (the "VIOXX Derivative Lawsuits"), with respect to the Company's public statements regarding VIOXX (collectively, the "VIOXX Shareholder Lawsuits"). Except for two VIOXX Shareholder Lawsuits pending in New Jersey state court, all of the VIOXX Shareholder Lawsuits have been or will be coordinated or consolidated in the U.S. District Court for the District of New Jersey.

Also as previously disclosed, there are investigations by the Securities and Exchange Commission (SEC), the Department of Justice and other governmental entities regarding VIOXX. The Company's U.K. subsidiary has been notified by the Medicines and Healthcare products Regulatory Agency in the United Kingdom (the "MHRA") of an investigation by the MHRA of compliance by the Company with EU adverse experience reporting requirements in connection with VIOXX. The Company is cooperating with the MHRA and the other governmental agencies in their respective investigations (the "VIOXX Investigations").

As previously disclosed, in addition to the lawsuits discussed above, the Company has been named as a defendant in litigation relating to VIOXX in various countries (collectively, the "VIOXX Foreign Lawsuits") in Europe, Canada, Brazil, Australia and Israel. In addition, litigation has been commenced against the Company's subsidiary in Turkey.

Based on media reports and other sources, the Company anticipates that additional VIOXX Product Liability Lawsuits, VIOXX Shareholder Lawsuits and VIOXX Foreign Lawsuits (collectively, the "VIOXX Lawsuits") will be filed against it and/or certain of its current and former officers and directors in the future.

Also as previously disclosed, the Company has product liability insurance for claims brought in the VIOXX Product Liability Lawsuits with stated upper limits of approximately $630 million after deductibles and co-insurance. This insurance provides coverage for legal defense costs and potential damage amounts that have been or will be incurred in connection with the VIOXX Product Liability Lawsuits. The Company believes that this insurance coverage extends to additional VIOXX Product Liability Lawsuits that may be filed in the future. The Company has Directors and Officers insurance coverage applicable to the VIOXX Securities Lawsuits and VIOXX Derivative Lawsuits with stated upper limits of approximately $190 million. The Company has fiduciary and other insurance for the VIOXX ERISA Lawsuits with stated upper limits of approximately $275 million. Additional insurance coverage for these claims may also be available under upper-level excess policies that provide coverage for a variety of risks. There are disputes with certain insurers about the availability of some or all of this insurance coverage and there are likely to be additional disputes. At this time, the Company believes it is reasonably possible that its insurance coverage with respect to the VIOXX Lawsuits will not be adequate to cover its defense costs and any losses. (Related article: Merck admits for the first time that it may have Vioxx liabilities)

Recently, Merck received notice that the Company's upper level excess insurers (which provide excess insurance potentially applicable to all of the VIOXX Lawsuits) commenced an arbitration seeking, among other things, to cancel those policies, to void all of their obligations under those policies and to raise other coverage issues with respect to the VIOXX Lawsuits. Merck intends to contest vigorously the insurers' claims and will attempt to enforce its rights under applicable insurance policies. The amounts actually recovered under the policies discussed in this section may be less than the amounts specified in the preceding paragraph.

The Company currently anticipates that one or more of the VIOXX Product Liability Lawsuits may go to trial in the second quarter of 2005. The Company cannot predict the timing of any trials with respect to the VIOXX Shareholder Lawsuits. The Company believes that it has meritorious defenses to the VIOXX Lawsuits and will vigorously defend against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the Company is unable to predict the outcome of these matters, and at this time cannot reasonably estimate the possible loss or range of loss with respect to the VIOXX Lawsuits. As of December 31, 2004, the Company had established a reserve of $675 million solely for its future legal defense costs related to the VIOXX Lawsuits and the VIOXX Investigations. In the first quarter, the Company did not increase the VIOXX legal defense reserve. The Company will continue to monitor its legal defense costs and review the adequacy of the associated reserves. The Company has not established any reserves for any potential liability relating to the VIOXX Lawsuits and the VIOXX Investigations. Unfavorable outcomes in the VIOXX Lawsuits or resulting from the VIOXX Investigations could have a material adverse effect on the Company's financial position, liquidity and results of operations.

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Bextra recall hurts Pfizer's financial performance

Vioxx and Bextra recall lawsuits move in high gear

Bextra recall hurts Pfizer's financial performance

Bextra recall and black box warning on Celebrex has put Pfizer into deep financial trouble. Net income dropped to just $270 million in the first quarter of this year from $2.3 billion last year, a drop of 88%. The company says that $766 million of charges taken this quarter attributable to the suspension of sales of Bextra.

It is important to point out that legal liabilities resulting from Bextra class action lawsuits are not included in these financials. Although small, Pfizer also faces a number of Celebrex lawsuits, apart from securities related lawsuits. That is why it is interesting that Hank McKinnell, chairman and chief executive officer is still saying, “Pfizer continues to deliver steady performance.”

Revenues also have been, and will continue to be, impacted by publicity and regulatory actions regarding COX-2-selective inhibitor drugs. Since the Bextra recall announcement, there have been repeated calls for Celebrex recall as well. The suspension of sales of Bextra in the U.S., E.U., and other markets in early April, Pfizer said, "...is expected to reduce our previously announced targeted full-year 2005 adjusted and reported diluted EPS by approximately $.05 per share. Bextra asset write-offs are expected to reduce our previously announced targeted full-year 2005 reported diluted EPS by an additional $.10 per share."

Analysts estimate that Vioxx liabilities could be as high as $55 billion though $38 billion is a more commonly used number. Some lawyers are using a more conserative number of $18 billion. At this time, no good estimate for liabilities resulting from Bextra and Celebrex lawsuits is available, though it is expected that Pfizer may have to pay billions to settle charges that it marketed two dangerous drugs.

Pfizer's response to COX-2 Developments

"Following the FDA decision to require boxed warnings of potential cardiovascular and gastrointestinal risk for all COX-2-specific pain relievers and all non-steroidal anti-inflammatory drugs (NSAIDs), including older non-specific drugs such as ibuprofen and naproxen, Pfizer will work with the FDA to add expanded risk information in the Celebrex label. Pfizer has accumulated extensive Celebrex clinical data over the past 10 years involving more than 40,000 patients, and we remain committed to conducting additional long-term clinical studies evaluating the benefits and risks of Celebrex. Pfizer will also work closely with the FDA to develop a guide to assist patients and their healthcare professionals in making the best decisions for treating their arthritis pain.

Regarding Bextra, Pfizer has suspended its sales in the U.S. in accordance with the FDA’s request. The FDA view is that Bextra’s cardiovascular risk could not be differentiated from other NSAIDs. However, the agency has concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra, already described in its label, warrants its withdrawal from the market. Pfizer respectfully disagrees with the FDA position regarding the overall risk/benefit profile of Bextra. However, in deference to the regulatory agency’s views, the company has suspended sales of the medicine pending further discussions with the FDA. For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options. In addition, at the request of European and other regulators, Pfizer has also suspended sales of Bextra in the European Union, Canada, Hong Kong, Singapore, Malaysia, South Africa, the Philippines, and Mexico. We will explore options with the regulatory agencies under which the company might be permitted to resume making Bextra available to physicians and patients. The company is in contact with other regulatory agencies around the world and will take appropriate measures based on those discussions." (Related article: Pfizer's detailed response on Bextra and Celebrex)

In a question asked to Pfizer about its position on Celebrex, the company said in a statement that "In keeping with the FDA’s position, Pfizer is advising physicians to consider the evolving information in evaluating the risks and benefits of all NSAIDs, including its COX-2-selective medicine Celebrex. While awaiting final labeling from the FDA, physicians should consider the available data on all these medicines when assessing individual patients to be treated for osteoarthritis, rheumatoid arthritis, or acute pain. Factors to be considered include information concerning the existing body of data, the risks of alternative treatments, and the individual patient’s underlying cardiovascular and gastrointestinal risk status. As with all prescription NSAIDs, Celebrex should be used at the lowest effective dose for the shortest duration, consistent with individual patient treatment goals."

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Pfizer response on Bextra and Celebrex

As part of its quarterly earnings announcement, Pfizer answered a series of questions related to its drug portfolio. As expected, there is a complete section on its Cox-2 drugs, Bextra and Celebrex. After Bextra recall was announced and FDA asked the company to put a black box warning on Celebrex, analysts have been deeply concerned about Pfizer's ability to survive the legal battles.

One of the questions asked was, "What recent regulatory actions have been taken concerning the safety of prescription and over-the-counter non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2-specific medicines?"

Pfizer's response

"The FDA Arthritis and Drugs Safety Committee and the Risk Management Advisory Committee met jointly on February 16-18 to review COX-2-specific inhibitors and other non-steroidal anti-inflammatory drugs (NSAIDs). After evaluating a substantial body of clinical data regarding Celebrex and Bextra and weighing the benefits and risks of these products, the advisory committees recommended to the FDA that these medicines remain available to patients with revised labeling.

On April 7, 2005, the FDA announced its plans for changes to the warnings sections of labels of NSAIDs, including COX-2 medicines, sold either by prescription or over-the-counter. These labeling changes will include boxed warnings for prescription NSAIDs regarding potential cardiovascular, gastrointestinal, and skin-reaction risks. Pfizer will continue to work closely with the FDA to implement labeling revisions for Celebrex that ensure its appropriate prescribing and use.

The FDA also requested the suspension of Bextra sales and marketing, based on its assessment of an unfavorable risk/benefit profile due to the additional increased risk of rare, serious skin reactions compared to other NSAIDs, including Celebrex. While Pfizer disagrees with this assessment of Bextra, it has respectfully complied with the FDA’s request and began the process of suspending Bextra sales on April 7. Discussions between Pfizer and the EMEA, Health Canada, and several other regulatory agencies in early April have led to similar regulatory requests regarding Bextra. Pfizer, while disagreeing with these agencies, has complied with their requests for suspension of sales and marketing of Bextra.

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NSAID increase risk of heart attacks in smokers

Smokers may want to take nonsteroidal anti-inflammatory drugs (NSAID) such as aspirin or ibuprofen as well, according to research reported the Annual Meeting of the American Association for Cancer Research. “The use of NSAIDs among smokers protected against oral cancer development,” said Dr. Jon Sudbø, a cancer researcher from the Norwegian Radium Hospital, Oslo, Norway, and lead author on the study.

People who took NSAIDs over extended periods of time and were light to moderate tobacco smokers had 65 percent less risk of developing oral cancer than smokers who went without NSAIDs, according to a population-based study on patients from the Norwegian Institute of Public Health and the Norwegian Cancer Registry. But at the same time, they had twice the risk of dying of a heart attack, stroke or other heart-related problem. This is in line with the results seen with arthritis patients who had higher risk of heart attacks from Cox-2 drugs (Vioxx, Celebrex, Bextra, Arocoxia, Mobic, etc.). This was the reason for recall of Vioxx and Bextra and a black box warning on Celebrex.

“The results of a significant reduction in oral cancer risk – particularly in light to moderate active smokers – suggest that NSAID use may provide anti-carcinogenetic effect while the smokers are subjecting themselves to tobacco insult,” Sudbø added. But it is fairly obvious that smokers with cardiovascular risks may want to stay away from NSAID without proper advice from their generaly physician.

The effect of the NSAIDs was best for those smokers who were considered 30 or less pack-year consumers of tobacco. A pack-year of smoking consists of averaging one pack of cigarettes per day per year. Those who smoke three packs per day for ten years, or two packs per day for 15 years are also considered 30 pack-year consumers. The effectiveness of NSAIDs diminished for smokers whose consumption was greater than 30 pack-year levels.

Sudbø and his colleagues in Norway and the United States analyzed health data on 908 individuals, half of whom had been diagnosed with squamous cell carcinoma of the oral cavity. They considered the use of six NSAIDs including aspirin, ibuprofen, naproxen (or Aleve), indomethacine, piroxicame, and ketoprofene, as well as acetaminophen. All types of NSAIDs were effective at reducing the rate of oral cancer.

Acetaminophen (paracetamol), a non-aspirin pain relief medication, was ineffective at reducing the risk of developing oral cancer among smokers.

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Links

American Association for Cancer Research

Norwegian Radium Hospital

Norwegian Institute of Public Health

Norwegian Cancer Registry

Vioxx Bextra recall lawsuits move in high gear

In one of the first Vioxx lawsuits to go on trial, Merck argued that Cheryl Rogers, widow of Howard Rogers (who passed away at the young age of 42) after taking Vioxx, was a liar. Merck argued that Howard Rogers never took Vioxx since the bottles that Cheryl Rogers has presented as evidence of his taking the drug show that that specific batch of the drug was made months after her husband died. (Related article: Merck continues its ferocious attack on Vioxx victims)

Beasley Allen, co-lead counsel for all Vioxx litigation, rejected Merck's attempts to dismiss the case, scheduled to go to court in late May. The story made headlines in The New York Times article of April 13, 2005 entitled, "Merck Asks for Dismissal in First of Suits Over Vioxx." He is the sole counsel for Cheryl Rogers. He now says that Merck's contention that Rogers never took the drug directly opposes the evidence he will supply in court. (Related article: Merck vows to fight Vioxx class action lawsuits vigorously)

According to the article, Merck requested dismissal in the Circuit or State Court of Clay County in Ashland, Alabama, case number CV 03-073, Cheryl Rogers V. Merck. Jere Beasley, founder and senior partner of Beasley, Allen, Crow, Methvin, Portis & Miles expressed shock saying that, "Merck's claims are unfounded and are a desperate attempt to avoid a day in court for a victim's family, and account for a drug that is responsible for thousands of deaths. In my opinion, they are trying to force us out of the case by making a most serious accusation against our client." "The key issue in the Rogers case is: Did Brad Rogers take Vioxx and did it kill him," Mr. Beasley explained. "We have evidence to prove that he was taking Vioxx before his death. An autopsy proved that the drug caused his death. We know from medical records of Mr. Rogers that he was prescribed Vioxx and that he took Vioxx on a regular basis before his death. We will prove our case in the courtroom." He added, "Clinical tests have shown that Vioxx is a terribly dangerous drug. It has killed literally thousands of unsuspecting victims who trusted the company and who had no idea that Vioxx caused heart attacks and strokes. FDA safety officer Dr. David Graham testified to Congress that taking Vioxx caused over 40,000 deaths." (Related article: FDA should have never approved Vioxx)

The Montgomery, Alabama based law firm has been in the forefront of the effort to have all of the cyclooxygenase-2 (COX-2) inhibitors (Bextra, Celebrex, and Vioxx) taken off the market since the law firm took on its first case against Merck over 4 years ago. Beasley Allen is spearheading the review of over 31,000 claims against the manufacturers of Bextra, Celebrex, and Vioxx, having filed 161 cases to date. He is currently evaluating more than 10,000 Vioxx cases and expects to file hundreds of lawsuits against Merck in the coming months. Beasley Allen has also been named co-lead counsel on all Vioxx lawsuits

The firm also included Pfizer in its attack today charging that Bextra recall may have been a step too late. Beasley Allen has 36 Bextra lawsuits pending against Pfizer, and another 1,000 cases to be filed. "Bextra has not only shown an increased risk for serious cardiovascular events in patients, it has also been linked to Stevens Johnson Syndrome (SJS), a skin disease that produces deadly, widespread lesions," according to attorney Paul Sizemore who is handling 1,000 potential Bextra cases for the firm. "Problems with this drug have been recognized for some time in the medical community," says Sizemore. He cites the Journal of Thoracic and Cardiovascular Surgery as reported in 2003: "Statistically significant increase in thromboembolic events (myocardial infarction, ischemia, cerebrovascular accident, deep vein thrombosis, pulmonary embolism) found in the group treated with Bextra (paracoxib/valdecoxib) post-op as compared to the placebo group. The relative risk for a thromboembolic event was 351 percent." Sizemore reveals that a second similar study was conducted by Pfizer, with results released in October 2004. This study again showed a statistically significant rise in the incidence of thromboembolic events where the relative risk was 288 percent. (Related article: A new study finds Celebrex as dangerous as Vioxx)

Dr. Garrett Fitzgerald, a cardiologist and pharmacologist at the University of Pennsylvania, said in a New York Times interview on November 10, 2004: "The magnitude of the safety signal with Bextra is even higher than what we saw in Vioxx... this is a time bomb waiting to go off." Dr. Curt Furberg, Department of Public Health Sciences, Wake Forest University School of Medicine, was quoted in the same article as saying: "Bextra is no different than Vioxx, and Pfizer is trying to suppress that information." (Related article: Original Bextra safety update from Pfizer)

"Pfizer has long ignored the safety signals associated with Bextra, ignored the warnings from leading scientists about its hazards, and ignored the results of multiple clinical studies evidencing a clear safety risk associated with this drug," says Sizemore. "Were it not for the renewed safety focus within the FDA, no doubt triggered by the Vioxx debacle, Pfizer would have continued to market and profit from a drug whose risks were not only well known, but also well proven,” adds Sizemore.

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Bextra recall does not help Celebrex

Bextra recall insufficient; Celebrex recall needed too

Patients taking the arthritis drug celecoxib (Celebrex) have a similar risk of heart attacks and stroke as those taking the withdrawn drug rofecoxib (Vioxx), according to a new study by the New Zealand Intensive Medicines Monitoring Programme (IMMP). A recent decision by the FDA banned Bextra but Celebrex only got a black box warning despite calls from numerous quarters for a recall of Celebrex as well.

According to the research published in the international journal Drug Safety, the University of Otago (New Zealand) study is an interim analysis following up approximately 11,000 of the 60,000 patients prescribed either medicine during 2001. Patients’ doctors were asked to supply information about adverse clinical events that occurred since being prescribed the drugs. The study shows that in the patients who had been followed up, there was no significant difference in the risk of thrombotic cardiovascular events (heart attacks and strokes) in patients taking celecoxib compared with those taking rofecoxib, says IMMP Head and study principal investigator Dr Mira Harrison-Woolrych.

In September 2004, Merck, the manufacturer of the COX-2 inhibitor drug rofecoxib (Vioxx) withdrew the product from the worldwide pharmaceutical market because of concerns about serious cardiovascular risks. (Related article: Vioxx recall history) This raised concerns as to whether celecoxib (Celebrex), the most popular alternative to rofecoxib, carries the same risks as rofecoxib. Or whether the increased risk of cardiovascular events seen with rofecoxib is confined to that agent or whether it is a class effect. “The lack of long-term, prospective data has made analyzing this problem very difficult,”said Rosie Stather, Editor of Drug Safety. “That is why this IMMP study is so important – it is a post-marketing study in a “real-life” setting, where there are none of the exclusion criteria that apply in the highly-controlled environment of a clinical trial.” Pfizer has always argued that despite Celebrex and Bextra being Cox-2 drugs, they are different from Vioxx at the molecular level. The FDA did not buy this argument and has forced Pfizer to recall Bextra and has imposed severe restrictions on Celebrex prescriptions. Pfizer refuses to agree with the FDA. (Related article: Bextra recall is no gain for Celebrex)

The IMMP is a national unit, based at the University of Otago and funded by the New Zealand Ministry of Health, which monitors the safety of specific medicines after they are licensed for use in New Zealand. The IMMP has been monitoring the safety of COX-2 inhibitors since 2001. The IMMP is one of only two monitoring programs in the world that proactively studies the safety of newly marketed drugs. This study will further intensify calls for recall of Celebrex as well.

“It was important to perform this interim analysis at this time, as the withdrawal of rofecoxib sparked world-wide concerns about the safety of celecoxib. This is the first study to directly compare the cardiovascular risks of celecoxib with rofecoxib in a ‘real-life’ post-marketing setting,” says Dr Harrison-Woolrych. “However, while this group of 11,000 patients is clearly defined and reasonably large, it should be understood that it may not be large enough to detect small differences in the rate of relatively uncommon events, such as heart attacks and strokes,” she says. Dr Harrison-Woolrych commented that the IMMP has been able to do this comparative study as both rofecoxib and celecoxib were monitored at the same time in New Zealand. “It was however important to adjust the results for differences between the two groups - for example, the celecoxib cohort was older and more likely to be taking the medicine long term,” she added.

The Editor of the journal Drug Safety, Ms Rosie Stather, commented that the results from the IMMP study were an important contribution to the growing international evidence on the safety of COX II inhibitors. “Together with information from other studies, the IMMP results will assist healthcare decision-makers in assessing the advantages and disadvantages of celecoxib in order to make recommendations regarding its use,” Ms Stather says.

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Bextra recall lawsuits filed in Canada

Bextra recall focuses limelight on all painkillers

Bextra recall lawsuits filed in Canada

Vioxx and Bextra class action lawsuits are not limited to the United States. Since Pfizer is a truly global company and almost all of its drugs are sold worldwide, the implications of Bextra recall are global as well. As Bextra related lawsuits are being filed here at home, our next-door neighbors are doing the same. Toronto law firm McPhadden Samac Merner Barry has launched a national class action against both Pfizer Canada and Pfizer U.S. The lawsuit is on behalf of Canadians who have suffered negative effects, including heart attack and death, from taking Bextra.

The lead plaintiff in the action is a gentleman by the name of Jesse Voutour of Mississauga who was taking Bextra because of his degenerative back condition. The amount claimed in the action is a total of $550 million. The claim is made by Voutour on his own behalf and on behalf of all those Canadians similarly affected. Legal counsel for Jesse Voutour, Bryan C. McPhadden says, "There appear to be serious problems with COX-2 inhibitors and it looks like Bextra is no exception." Zoran Samac, another lawyer with the firm added: "If the manufacturers of these drugs knew about the potential dangers or failed to properly investigate the risks, they should be held legally responsible, particularly given the considerable profits made."

Another personal injury lawyer Greg Monforton today announced that his firm is also evaluating more than 3,000 Vioxx-related inquiries from across Canada and that he expects to file hundreds of lawsuits against Merck in the coming months. Monforton is a senior partner at Greg Monforton & Partners and Vice-President of the Ontario Trial Lawyers Association. According to him, virtually all of his firm's Vioxx clients have suffered either heart attack or stroke, resulting in serious injuries and in many cases, death. He says, "As our investigation unfolds, it is becoming clearer every day that the conduct of Merck has resulted in the needless deaths of literally thousands of people in North America. We believe Merck misled its own shareholders, the medical community and the public by marketing and distributing a drug that it knew carried significant risk for stroke and heart attack. We also believe that Merck pursued profit at the expense of the safety and well being of the general public."

Until it was withdrawn from the market by Merck, Vioxx was a highly popular and heavily advertised arthritis drug. It was heralded as an improvement over older drugs like Ibuprofen and Naproxen because of marketing claims of less stomach irritation. However, recently published data calls into question this advantage of Vioxx and also raises questions of "serious cardiovascular events" related to Vioxx. (Related article: Vioxx side effects confirmed in yet another study)

Monforton said that he and his law firm are now part of a consortium of plaintiffs' firms which is alleging that in selling Vioxx, "the conduct of Merck was far below the standard expected of a reasonable and prudent pharmaceutical manufacturer". He said plaintiffs' firms are banding together because there is "significant work to be done and a lot is at stake for our clients." Thus far Monforton has not asked for class-action status for any of his cases, saying he is not surprised Merck is talking of battling the cases one by one. "We are prepared to do this patient by patient, case by case," Monforton said. In a demonstration of this approach in a case in Alabama, Merck asked the judge yesterday to throw out the case of a widow whose husband died after taking Vioxx on the ground that she is lying.

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Sources

McPhadden Samac Merner Barry

Greg Monforton & Partners

Ontario Trial Lawyers Association

Bextra recall prompts Michigan law change

Michigan is the only state in the United States that has robbed its residents of the right to ask for compensation if a drug company makes defective drugs. The idea initially was to make the state "business friendly" but the net result is that thousands of victims of Vioxx and Bextra (and many other drugs) have no legal rights to sue drugmakers. Texas also has some laws that make it extremely difficult for residents in the state to sue drugmakers. (Previous article: Michigan and Texas residents not allowed to sue Merck)

The democrats in Michigan now want to change the law so that Michigan residents will have the same rights as residents of 49 other states. Most other countries in the world allow similar rights to their citizens. The Michigan House Democrats recently announced a package of bills to end the drug industry’s legal immunity from responsibility for dangerous drugs, saying the industry must be held responsible when its products harm Michigan residents. It is unlikely that the legislation will pass since it is bound to encounter stiff opposition from drugmakers, pharmaceutical industry lobbyists, and Republicans.

“There is only one state in the country that gives the powerful drug industry absolute immunity for the harm their products cause, and that state is Michigan,” said Rep. Dianne Byrum (D-Onondaga), House Minority Leader and a lead sponsor of the bills. “We should be leading the country in consumer protection. But when it comes to protecting consumers from the drug industry, we’re dead last. It is shameful that Michigan residents who have been harmed by prescription drugs have no recourse simply because they live in our state.”

The proposed bills would repeal a 1996 law granting legal immunity to drug companies. Passed by Gov. John Engler and the Republican-controlled legislature, that law gives companies complete immunity from legal action so long as the drug in question has been approved for safety and efficacy by the U.S. Food and Drug Administration (FDA). However, now it is widely believed that the FDA has been hijacked by the drug industry and no one can trust the judgment of FDA any more when it comes to drug safety. (Related article: Doctors lose trust in FDA)

But in the wake of recent scandals surrounding drugs like Vioxx, Rezulin, Fen-Phen and Bextra; the revelation that many members of FDA drug-approval boards have ties to the pharmaceutical industry; and the public testimony of FDA scientists like Dr. David Graham that the FDA’s system for drug evaluation is “broken,” House Democrats said Michigan residents cannot blindly trust the FDA and must have legal recourse when harmful drugs make it to the market. (Related article: Merck successfully manipulated FDA in Vioxx recall case)

The Democrats’ bills are retroactive so that Michigan residents harmed by prescription drugs since 1996 can seek legal remedy, and include drug companies in the Consumer Protection Act, from which they are currently exempted. “For too long, our residents have been put at risk by FDA-approved medications like Vioxx and Rezulin, only to be told by the courts they’re on their own,” said Rep. Gary McDowell (D-Rudyard). “It’s past time to end special protection for big drug companies that profit from drugs that harm and even kill people.”

In February, claims by 187 Michigan residents against Warner-Lambert, maker of the diabetes drug Rezulin, were dismissed by a New York federal court judge because of the Michigan law. Rezulin was pulled off the market in 2000 after it was linked to nearly 400 deaths and thousands of cases of liver failure.

Vioxx was banned in 2004, and may have caused heart attacks or cardiac deaths in up to 139,000 Americans, based on Merck’s own studies. And the weight-loss medication Fen-Phen was banned in 1997 after causing hypertension and heart-valve abnormalities in tens of thousands of people nationwide. Bextra was taken off the market last week due to an increased risk of heart attack and serious skin reactions among the painkiller’s users.

“The drug industry has the highest profit margin of any industry in the country,” said Rep. Marie Donigan (D-Royal Oak). “Those profits were built on drugs like Vioxx, which raked in $2.5 billion in worldwide sales in 2003 alone. It is ludicrous that such a profitable industry should be allowed to dispense any medication it can strongarm the FDA into approving and then escape responsibility when those drugs harm our residents.

“Michigan residents shouldn’t be treated like second-class citizens,” Donigan added. “It’s time for Michigan to join the other 49 states and hold the drug industry accountable for its actions.”

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Bextra recall is no gain for Celebrex

While it was good news for Pfizer that the FDA did not ban Celebrex along with forcing a recall of Bextra, but it seems that Americans do not trust Celebrex any more. According to Vector One, a research firm that tracks prescriptions, most of the patients who were on Bextra are switching to traditional, generic NSAID. At second place is Mobic. Celebrex comes at third place. (Related article: Americans abandon Vioxx, Celebrex, and Bextra)

And it is unlikely that the controversy over Celebrex will die soon. There are numerous calls from all sides to recall Celebrex as well. Parker & Waichman, a law firm actively pursuing Vioxx and Bextra litigation is joining Public Citizen and arguing that "...the failure to remove Celebrex from the market puts millions of people at an unnecessary risk." (Related article: Celebrex recall demanded)

An unpublished study finished in 2000 indicated increased cardiac risks associated with Celebrex. A more recent study sponsored by the National Cancer Institute discovered that Celebrex's risk of causing a major cardiovascular event was two-and-a-half times greater than that for people taking a placebo. In 2004, almost twice as many prescriptions were written for Celebrex as for Bextra -- 23.9 million prescriptions compared to 12.9 million.

In the meantime, Bextra attorneys representing patients are accusing Pfizer of ignoring drug safety. Woody Wilner, a Bextra attorney representing Mary Ellen Mule (who suffered a stroke after taking Bextra), is quoted as saying, "Instead of following scientific evidence, you (Pfizer) followed your desire to maximize profits of your company."

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Bextra recall class action lawsuits filed

The volley of lawsuits against Pfizer has already begun in the case of Bextra recall. In an announcement today, the law firm of Kline & Specter said that three Lawsuits have been filed against Pfizer on behalf of three people injured by the recently banned prescription drug Bextra. Two of the plaintiffs suffered heart attacks and one sustained a stroke after taking the painkiller. (Related article: Bextra recall lawsuits expected to explode during coming weeks)

The suits were filed in the Supreme Court of the State of New York on Friday, one day after New York-based Pfizer removed Bextra from the market at the urging of the U.S. Food and Drug Administration (FDA). The FDA also directed that a black box warning be placed on Celebrex, the other Cox-2 drug that Pfizer makes. FDA decided not to ban Celebrex but a black box warning means that the drug should be taken if no other option is appropriate for a patient.

The plaintiffs are all represented by Thomas R. Kline, who on Friday was also named to the Plaintiffs Steering Committee in the federal litigation over Vioxx. This is a major breakthrough for the law firm since membership on the committee gives them enormous influence over Vioxx litigation.

The Bextra lawsuits claim, among other things, that Pfizer failed to adequately and properly test Bextra and failed to warn doctors, patients and others about its potential risks. Studies showed that patients who used Bextra were more likely to suffer heart attacks and strokes.

The plaintiffs in the Bextra suit are Luis G. Flores, 33, of Texas, who suffered a heart attack on Aug. 5, 2004 and, as a result, was forced to undergo two stent implantation surgeries; Jimmy Kitchen, 67, of Arkansas, who suffered a heart attack on June 12, 2002; and Theodis Maddox, Jr., 48, of Arkansas, who suffered a stroke and temporary paralysis and weakness on his right side.

A class action lawsuit was also filed separately against Pfizer today on behalf of all persons who died or were injured by Bextra, according to the Chicago law firm Kenneth B. Moll & Associates. This firm is also active in Vioxx class action lawsuits. "The decision of the FDA to withdraw Bextra from the market is a victory for consumers, and affirms that the risks of these drugs outweigh the benefits," said Kenneth B. Moll. "However, countless individuals have already suffered severe or fatal injuries including heart attacks, strokes, embolisms, gastrointestinal bleeding, ulcers, and skin reactions such as Stevens-Johnson syndrome. This drug did not carry sufficient warnings regarding the potentially fatal side effects it can cause."

As previously reported, Louisiana attorneys for patients have already asked a judicial panel in Washington, D.C. to move all the Bextra related lawsuits in the country to one federal court, the United States District Court for the Eastern District of Louisiana, which is in New Orleans, for consolidation and management.

German lawyer Michael Witti and U.S. firm Nagel Rice & Mazie are preparing a class action suit against drugs giant Pfizer over claims relating to its arthritis drug Bextra, Witti said on Sunday in an interview with Reuters. Similar lawsuits are expected worldwide, pretty much in line with Vioxx lawsuits.

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Bextra recall focuses light on painkillers

After Bextra recall last week, the spotlight is back on all Cox-2 drugs, including Celebrex, which will now carry a black box warning. Apart from numerous stories in the print and online media, the television stations are highlighting the drug recalls. The "Four Corners" program on ABC in Australia is similar to the Dateline (on NBC) in the United States. No wonder then that the TV station did an excellent program on Vioxx recall (and the decision to ban Bextra, as well as the controversy surrounding Celebrex). (Related article: Bextra banned worldwide)

Jonathan Holmes, the reporter for Four Corners, reports that as many as 300,000 Australians used Vioxx before it was recalled in September of 2004. Professor Les Cleland, of the Royal Adelaide Hospital in Australia, who has analyzed the data (along the lines of the analysis by Dr. David Graham), disclosed on the program that Vioxx has caused more than 1,000 cases of personal injury in Australia, with up to 300 Australians dead. In the United States, as many as 140,000 injuries are attributed to Vioxx. Holmes writes, "...in Australia, where high doses of Vioxx were never authorised, it’s feared the number of dead and injured might dwarf the toll of Australian life in the Bali bombings." Like the United States, where Vioxx class action lawsuits have exploded, Australian victims are also considering Vioxx litigation against Merck.

The Vioxx controversy has been a big story in Australia and the number of deaths has led to widespread condemnation of both Merck and and Therapeutic Goods Administration (TGA). Holmes says, "...few questions are being asked in Australia about the role of our regulator, the Therapeutic Goods Administration, which is entirely funded by fees from drug companies." While the FDA is not 100% funded by drug companies, a large portion of the budget does come from American drugmakers through user fees. The drugmakers also employ as many as 600 lobbyists who try to influence decision making at the FDA.

The program invited Pfizer to participate but Pfizer's office in Australia declined a request for an interview saying that, "...it may prejudice our application for a Ministerial review." "Ministerial review" in Australia means that since Pfizer does not agree with the conclusions of the Therapeutic Goods Administration in the case of Celebrex and Bextra, it is asking for a review of the decision.

Pfizer also continues to stand by the safety of Celebrex, arguing that it is no more dangerous than other painkillers. In a letter to the TV station, it says, "...it is important to note that just one published study shows a potential adverse CV effect - and that was at four times the usual dose used in Australia...The cardiovascular safety of Celebrex has been specifically studied to a much greater extent than traditional NSAIDs."

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History is being repeated all over again. When Merck announced a Vioxx recall, it did so without accepting any responsibility for 140,000 cases of personal injury to Americans. No surprise then that Vioxx patients who have been hurt are lining up to file class action lawsuits against Merck.

Many analysts expected that Pfizer would simply do the right thing and admit that all Cox-2 drugs, including Celebrex and Bextra, do have some safety issues and the drugmakers should work together with the FDA to resolve them. The matter would have ended there. On the other hand, Pfizer kept arguing that Celebrex and Bextra had no safety issues and refused to do anything until a forced Bextra recall by the FDA last week. In addition, a strong black box warning on Pfizer's other Cox-2 drug Celebrex. In other words, users of Celebrex and particularly Bextra have a legal right to claim personal injury and demand compensation from Pfizer.

The Bextra class action lawsuits process has already begun and is expected to follow the Vioxx class action lawsuits. But everything is not the same, despite numerous similarities between the two:

• While Merck voluntarily withdrew Vioxx, the FDA forced Pfizer to recall Bextra. The FDA did not agree with Pfizer and a panel of experts that Bextra was safe enough to be sold in the US. Drug regulatory agencies worldwide concur with the FDA and have directed Pfizer to recall Bextra.
• The number of Americans who have taken Bextra and those that have actually been injured by it is relatively small compared to Vioxx.

Should you consider Bextra litigation against Pfizer?

If you have taken Bextra for an extended period of time and have experienced its side effects, it is a good idea to discuss your situation with your doctor and a Bextra attorney. Not everyone is a good candidate for such litigation and an experienced lawyer is in a position to evaluate your specific case and determine if you should proceed forward.

It is also a good idea to work only with reputed law firms that specialize in product liability lawsuits. There are a lot of lawyers that will try to mislead you but if you do your research before picking the right one, you will save yourself a lot of hassle and make sure that you get the right compensation.

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Worldwide Bextra recall begins

In line with the FDA announcement on Bextra recall in the United States, and as expected, Health Canada, the equivalent government body in Canada, has asked Pfizer Canada to voluntarily discontinue sales of Bextra in Canada until safety issues have been resolved. According to an announcement by Health Canada, Pfizer has agreed and will be discontinuing sales immediately in Canada. (Related article: Complete coverage of Bextra recall)

In most cases, Health Canada (like many other drug agencies worldwide) follows the decisions of the FDA but in some cases, for instance, Adderall recall, Health Canada went ahead despite resistance, and even pressure, from the FDA. Health Canada continues to stand by its decision while FDA has refused to act.

Health Canada has further asked Pfizer to submit evidence to establish the safety of Bextra under the conditions of use for which it is recommended. In addition Pfizer has been asked to provide Health Canada with a risk/benefit analysis indicating Bextra's unique therapeutic advantage. (Related article: Bextra safety doubted in two studies)

Similarly, the European Medicines Agency (EMEA), the drug regulatory agency in Europe has also directed Pfizer to recall Bextra in Europe. In the ongoing review of Cox-2 inhibitor drugs, Europeans have been more careful and have imposed stronger restrictions on their prescriptions than the United States. An EMEA panel is scheduled to meet later this month and may impose further restrictions on other Cox-2 drugs like Arcoxia (Etoricoxib), Prexige or Dynastat (Parecoxib), Mobic (Meloxicam), and others.

Drug regulatory agencies in Australia, Singapore, and New Zealand have already restricted Bextra and Celebrex prescriptions and as the decisions are made over the next few days, formal announcements are expected soon. Essentially in almost all cases, patients are being asked to discontinue taking Bextra and speak to their doctor immediately. Other guidelines are identical to those provided by the FDA.

In India, where Bextra is not sold but Indian companies market generic versions of valdecoxib, doctors are already switching their patients to other drugs. The Drugs Controller General of India (DCGI), Ashwini Kumar, told an Indian newspaper the Economic Times that the process of reviewing the drug has been initiated and a decision is expected soon.

Regarding refunds for unused Bextra pills, if you live in the United States, you may bring them to your local pharmacy and request a refund. Or you may contact the National Notification Center (NNC) at 1-866-608-3935 to receive a patient product return kit by mail. NNC will process the refund on Pfizer's behalf. While both FDA and Pfizer are asking arthritis patients to talk to their doctors, it is also possible to call the BEXTRA Customer Support Center at 1-866-623-9872. In countries outside the US, you must contact the local office of Pfizer or your pharmacy where you purchased the drug.

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Bextra recall announced

The Food & Drug Administration (FDA) has finally did the right thing by announcing a recall of Bextra, a Cox-2 inhibitor drug manufactured by Pfizer. After months of speculation and fear that the drug industry will be able to push the FDA to leave a highly dangerous drug on the market, it seems that the FDA has come to its senses and has taken a decision that will ensure that only safe drugs are available to American people. (Related article: Bextra and Celebrex problems hurt Pfizer financially)

In an announcement this morning, the FDA has asked Pfizer to recall Bextra (or valdecoxib) from the market because the "overall risk versus benefit profile for the drug is unfavorable." A FDA panel had come up with a similar finding but since several members of the panel had financial ties to Pfizer, they had recommended that the drug stay on the market. It is common for the FDA to accept recommendations of such panels but due to conflicts of interest of members, there was almost a universal demand that the Bextra should be recalled.

Here is a brief history that led to the recall of Bextra:

September 30, 2004: Pfizer starts an aggressive marketing campaign for Bextra after Vioxx recall by Merck.

December 9, 2004: FDA announces that it is issuing a black-box warning on Bextra.

January 24, 2005: Public Citizen demands that FDA recall Bextra.

January 30, 2005: Kaiser Permanente, one of the largest HMO's in the US, bans Bextra.

February 17, 2005: Pfizer again claims that Bextra is a safe drug.

February 18,2005: FDA panel recommends that Bextra stay on the market with a black box warning.

April 7, 2005: FDA does not agree with Pfizer and the panel and asks Pfizer to recall Bextra

Even before Bextra recall announcement, Americans who have been hurt by Bextra have filed class action lawsuits against Pfizer. Today's recall announcement will result in an explosion of lawsuits against Pfizer in line with Vioxx class action lawsuits.

In a statement released by Pfizer, it says that "Pfizer respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA." Pfizer said that it will explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients. For now, Pfizer announced, patients should stop taking Bextra and contact their physicians about appropriate treatment options.

In addition, at the request of European regulators, Pfizer will also suspend sales of Bextra in the European Union. The company is in contact with other regulatory agencies around the world and will take appropriate measures based on those discussions. It is expected that withdrawal of Bextra will be worldwide.

In the same announcement, the FDA says that Celebrex will stay on the market with a blackbox warning and if Merck wants to resume sales of Vioxx, the FDA will review the application.

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Celebrex and Bextra problems hurt Pfizer

The Vioxx recall saga was extremely hard on Merck and there is widespread speculation that the firm may not survive Vioxx litigation and may be forced to file for bankruptcy. But its number one competitor in Cox-2 business, Pfizer, is hurting equally bad. Pfizer Vice Chairman David Shedlarz told an analyst meeting yesterday that Pfizer expects lower year-over-year sales of the Cox-2 franchise. Since the controversy over Vioxx, Celebrex, and Bextra that started in the last quarter of 2004, both Merck and Pfizer have been target of hundreds of class action lawsuits. (Related article: Vioxx class action lawsuits)

Karen Katen, Pfizer vice chairman and Human Health president, said in the same meeting that, "We believe that, with continued clinical work and appropriate labeling, these medicines will remain important treatment options for patients and doctors for many years to come." She was referring to Pfizer's Cox-2 portfolio that includes Celebrex and Bextra.

In a rather bizarre development in February of this year, a panel of doctors with financial ties to Merck and Pfizer recommended to the FDA that Vioxx sales be allowed to resume while Celebrex and Bextra could stay on the market. The company announced that it "...looks forward to finalizing changes to its U.S. labeling with the U.S. Food and Drug Administration (FDA) as well as moving ahead with plans for clinical studies to further explore the benefits as well as the risks of the Cox-2 specific medicines compared to older, non-selective medicines. In the interim, Pfizer remains focused on the importance of these products for millions of patients around the world." The panel had, however, agreed that these drugs are quite dangerous and should carry the strongest warning (called the black box warning). (Related article: Pfizer may have hidden Celebrex risks)

Since the pressure on Pfizer has mounted over Celebrex and Bextra, Pfizer has launched a company-wide initiative to streamline the organization, fund key investments, and realize significant cost savings. Pfizer is targeting $4 billion in total annualized cost savings by 2008, which represents approximately 12 percent of Pfizer’s current cost base. (Related article: Pfizer being investigated by the Justice Department and attorneys general regarding safety of Celebrex and Bextra)

Pfizer vice chairman David Shedlarz said the financial impact of these efforts will be modest in 2005 but is expected to yield significant benefits in 2006 and 2007. In 2006, the company expects the operational and financial benefits of this productivity initiative to drive a return to double-digit growth in adjusted earnings. For 2007, the company expects revenue growth from both new products and major in-line products will drive accelerating double-digit adjusted earnings growth. Productivity initiatives will also contribute to growth in 2007.

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Merck admits Vioxx recall lawsuits liabilities possibility

After Vioxx recall, Merck is facing litigation in form of class action lawsuits claiming personal injury and securities fraud. In almost all cases, Merck has decided to take a very aggressive stance and the firm continues to pretend as if it has no Vioxx liabilities or any threats to its survival. In keeping with that spirit, the firm has refused to make any provisions for its Vioxx liabilities despite estimates by analysts that its liabilities could be as high as $38 billion, or even $55 billion.

On March 24, 2005, however, the Compensation and Benefits Committee of the Board of Directors of Merck provided that the pre-determined range of earnings per share ("EPS") established for 2005 for Performance Share Units ("PSUs") granted on February 22, 2005 may be adjusted to reflect the possible effects of the establishment of reserves for any potential liability relating to the VIOXX litigation. In other words, for the first time, Merck is at least admitting that there might be liabilities related to Vioxx litigation.

The company, in a filing with the Securities and Exchange Commission (SEC), says, "Merck has not established a reserve for any potential liability relating to the VIOXX litigation and has no present intention to do so. Merck establishes reserves for contingencies when it is probable that a liability has been incurred and the amount can be reasonably estimated."

This attitude means that the firm may be caught totally by surprise if the jury awards damages to the victims in the Vioxx class action lawsuits. At that point, shareholders are likely to file even more lawsuits against the firm for not planning properly for potential liabilities. No wonder then that Merck's insurers are abandoning the firm and there is widespread speculation that the firm may go bankrupt.

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Dr. Robert Burton, writing in the online magazine Salon, charges that Merck "knew there were heart risks associated with its painkiller -- but its own studies were designed to avoid finding out how serious they were. Without this requisite skepticism, we are at their mercy -- in this case, with fatal consequences. The U.S. Food and Drug Administration has linked Vioxx, since it was released in 1999, to more than 27,000 acute heart attacks and sudden cardiac deaths. What the agency didn't report was its own culpability in the debacle." In other words, the FDA has been hijacked by the drug industry and Americans are simply at the mercy of the drugmakers now.

But Vioxx should have never been approved in the first place, according to FDA's very own scientist Dr. David Graham. Vioxx (and its competitors like Celebrex, Bextra, Prexige, Arcoxia, etc.) are really not needed by most arthritis patients. In research completed by Bill H. McCarberg, Perry G. Fine, John E. Ware, and Carol Estwing Ferrans, simple heat wraps gave more relief to people with arthritic knee pain than over-the-counter drugs. The patients in the trial were simply either given Tylenol, which contains acetaminophen, or ibuprofen, or they wore a wrap with no heat or a ThermaCare Heat Wrap for eight hours a day. Those who wore the heat wrap had significant benefits in pain reduction and more flexibility compared to the others, the researchers found. (Related article: Nexium as an alternative to Vioxx)

In another study completed by the Altoona Arthritis and Osteoporosis Center, researchers found that patch therapy provides similar pain relief as oral medications for patients with osteoarthritis (OA) knee pain. The exploratory study involved a head to head comparison of applying the lidocaine patch 5% (Lidoderm) or taking celecoxib (Celebrex) 200 mg per day. (Related article: Will you take Vioxx if it comes back?)

Lidoderm (lidocaine patch 5%) is FDA-approved for the relief of pain associated with post herpetic neuralgia (PHN). Lidoderm produces an analgesic effect by the penetration of lidocaine from the patch into the epidermal and dermal layers of the skin, without loss of sensation or numbness. The Lidoderm patch should only be applied to intact skin. The most frequently reported adverse events with the Lidoderm patch are application site reactions, including erythema, edema, discoloration, burning sensation, pruritus or abnormal sensation. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. (Related article: Safe painkiller guide after Vioxx recall)

The FDA-approved dosing for Lidoderm is up to three patches applied for up to 12 hours within a 24-hour period. Lidoderm has not been approved by the FDA for any indications other than for the relief of pain associated with PHN, and its safety and efficacy in other indications have not been established.

Due to safety concerns regarding the entire COX-II inhibitor class in the fall of 2004, the sponsor of the study, Endo Pharmaceuticals Inc., voluntarily elected to prematurely halt the study prior to reaching the original enrollment target. However an analysis of data after six weeks of treatment showed that of the patients treated in the Lidoderm group, 54% experienced a 30% or greater improvement in average daily pain intensity; (studies have reported that 30% or greater reductions in pain intensity are clinically meaningful to pain patients). In the Celebrex group, 62% experienced a 30% or greater improvement in average daily pain intensity. In addition, clinically meaningful reductions in pain were noted in both treatment groups at week 12.

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Links

Salon
Endo Pharmaceuticals
Lidoderm
Altoona Arthritis and Osteoporosis Center