Pfizer may have hid Celebrex side effects

Public Citizen, a national, non-profit consumer advocacy organization, that called for recall of Celebrex and Bextra earlier, has now presented compelling evidence in support of their request. It is now well-known that both Celebrex and Bextra are no longer considered as safe as FDA thought they were when it approved them. After the recall of Vioxx and disclosure of data from a range of studies, it has been found that Celebrex and Bextra both have adverse side reactions that are simply too high. Accordingly, Kaiser Permanente, the largest HMO in the United States, has already banned Bextra prescriptions. Experts expect that both Celebrex and Bextra may soon face similar bans from other healthcare organizations. (Related article: Pfizer highlights risks of Celebrex recall)

There were 36 million prescriptions written in the U.S. for Celebrex and Bextra last year—thus about three million prescriptions a month. There was a significant jump in prescriptions after Vioxx was recalled, but when evidence about the dangers of Celebrex and Vioxx were pointed out in December 2004 and January this year, prescriptions have dropped rapidly. (Related article: Pfizer's position on safety of Celebrex)

Sidney M. Wolfe, MD, Director of Public Citizen's Health Research Group, in a letter addressed to the acting commissioner of the FDA, writes that they have discovered the results of an unpublished randomized placebo-controlled study by Pfizer, finished more than four years ago, that showed a significantly increased rate (3.6-fold) of serious cardiovascular adverse events and more than a doubling in the rate of cardiovascular deaths in people using Celebrex compared to those using a placebo in a study concerning Alzheimer’s disease. (Related article: FDA sides with drug companies rather than American people in Vioxx recall case)

Despite these older, but previously undisclosed findings, when Pfizer recently announced the results of an ongoing colon polyp prevention trial that was stopped because of a 2.5 to 3.4-fold increased risk of fatal or non-fatal major cardiovascular events in patients using celecoxib, Pfizer CEO McKinnell stated that “these clinical trial results are new.” (Related article: Pfizer stands by the safety of Celebrex)

Dr. Wolfe says that when the results of this study were first posted on the PhRMA web site around the beginning of this month, there was no mention of the statistical significance of these cardiovascular adverse events. But when the posting was modified last Monday (the day Public Citizens' petition to ban celecoxib or Celebrex and valdecoxib or Bextra was filed) the company admitted that “A statistically significant difference favoring placebo in adverse events was observed for certain CV-related body system terms (Cardiovascular Disorders,General; Heart Rate and Rhythm Disorders; Myo, Endo, Pericardial & Valve Disorders)."

Dr. Wolfe also accuses Pfizer of hiding this data, saying that there was certainly no mention of this study in February, 2001 when there was an FDA hearing concerning the results of the CLASS study, finished in 2000, that failed to show any gastrointestinal advantage over older NSAIDs for celecoxib or Celebrex. Nor has FDA ever mentioned it in the context of all of the public discussion of COX-2 dangers, especially in the past four months. If the FDA has had this study for a considerable amount of time and did not make the results public, it has seriously failed, once again, in its mission to protect the public health. If, as is entirely possible, Pfizer did not send these results to the FDA until after the December 17th announcement of similarly increased cardiovascular risk in the polyp-prevention study, the company has set itself up for enormous liability for having failed to inform the outside world of these important findings. (Related article: Celebrex class action lawsuits follow the Vioxx case approach)

Recommended article: Celebrex class action lawsuits explode

Bextra banned by Kaiser Permanente

Bextra, a Cox-2 drug, that was prescribed as an alternative to Vioxx and Celebrex, has been banned by Kaiser Permanente, a HMO based in Oakland, California. It may be recalled that a warning about Bextra is already in place by the FDA (and other drug agencies all over the world) while it reviews the complete family of drugs. The FDA issued the warning in December last year after research disclosed several adverse side effects of Bextra. (Related article: Vioxx recall focuses limelight on all Cox-2 inhibitor drugs)

This is a remarkable development since Kaiser Permanente is the largest HMO in the United States. The program has approximately 8 million members. Analysts expect that other healthcare providers will follow suit soon, may be even before the FDA and European Medicines Agency (EMEA) announce their decisions whether to ask Pfizer to recall Bextra. Pfizer was asked by the FDA to stop all direct-to-consumer advertising related to Bextra and later FDA issued a warning letter to Pfizer detailing how Pfizer has engaged in misleading advertising.

Kaiser said that its Bextra ban would take effect right away for new prescriptions and March 1 for refill prescriptions. Kaiser said its moratorium on Bextra will continue for six months, or until the FDA or the drug's manufacturer, Pfizer Inc., can prove the drug is safe, according to a Kaiser press release. (Related article: Bextra safety doubted in two studies)

Since the recall of Vioxx in September of 2004 by Merck, other drugs like Celebrex, Bextra, Prexige, Arcoxia, etc. have come under greater scrutiny. Several studies have shown that these drugs provide little or no benefit when compared to inexpensive, over-the-counter drugs like Ibuprofen and Paracetamol. Most of the benefits that Pfizer and Merck claimed about their drugs were never really proved. (Related article: Vioxx should have never been approved)

Most doctors and patient rights groups have been demanding that Bextra should be recalled at least till its safety profile is better understood. (Related article: Bextra safety update from Pfizer) Merck, the manufacturer of Vioxx, is expected to face tens of thousands of plaintiffs in class action lawsuits all over the world. Merck is also being investigated by the Department of Justice, the Securities and Exchange Commission (SEC), and Congress for hiding information about side effects of Vioxx and for misleading patients, doctors, and investors. (Related article: Merck being formally investigated by SEC for Vioxx recall)

Pfizer, which has so far stood by the safety of both Celebrax and Bextra, and has repeatedly refused to recall either or both the drugs, is also facing a series of class action lawsuits from patients and shareholders. (Related article: Bextra class action lawsuits against Pfizer grow)

In the aftermath of the Vioxx recall, Pfizer benefited a lot as arthritis patients switched to Celebrex or Bextra. However, after reports about Bextra were published in December last year, prescriptions for Bextra have dropped rapidly. (Related article: Pfizer sales hurt by drop in Bextra prescriptions)

A ban by Kaiser Permanente on Bextra, apart from pushing other HMOs to do the same, will also put pressure on the FDA to review the risks more carefully. Legal experts say that if HMOs do not take action right now and if at some point Celebrex and Bextra are found to be responsible for injuries (Related article: As many as 140,000 Americans alone are reportedly injured by Vioxx), they will also be liable like Pfizer for knowingly causing death and injuries.

Recommended article: FDA recommends limited Bextra prescriptions after Vioxx scare

SEC investigates Vioxx recall by Merck

Merck is reporting that on January 27, 2005, the company received notice that the Securities and Exchange Commission (SEC) has issued a formal notice of investigation relating to its recall of Vioxx in September 2004. Merck adds that, "This action was not unexpected and the company will continue to cooperate with the SEC." (Related article: Vioxx recall hearings in the United States Senate)

What does SEC do?

The Securities and Exchange Commission has five Commissioners who are appointed by the President of the United States with the advice and consent of the Senate. The primary mission of the SEC is to protect investors and maintain the integrity of the securities markets. A formal probe of Merck's action with regards to withdrawal of Vioxx gives the SEC staff the power to issue subpoenas for documents or testimony. (Related articles: SEC announced an informal investigation of Merck in Vioxx case in November 2004 and Merck sued by New York Attorney General)

Why is Merck being investigated by the SEC?

Since Merck is a publicly held company with its shares held by both individual shareholders and institutional investors, SEC's job is to make sure that their interests are protected at all times by a company. If SEC finds out that a company withheld information from investors or did not disclose it on time or misled investors, the company is liable for legal action. (Related article: Vioxx recall leads to shareholder lawsuits against Merck)

As readers may recall, Merck withdrew Vioxx on September 30, 2004. However, disclosures made since then clearly establish that Merck may have known as early as 1998 (according to some claims) that Vioxx was not a safe drug and could lead to heart attacks and other side effects, including death. However, the company pushed Vioxx for an approval by the FDA using the fast-track process. (Related article: Vioxx should have never been approved, FDA scientist says) Merck continued to advertise Vioxx aggressively spending hundreds of millions of dollars, targeted mostly at patients who were unlikely to benefit from Vioxx (and were more likely to suffer from heart diseases). Merck scientists also knew that Merck was no better than an over-the-counter drug like Ibuprofen or Paracetamol. (Related article: Vioxx patients misled by Merck)

When more evidence emerged that Vioxx was actually injuring tens of thousands of people (Related article: According to latest estimates by the FDA, as many as 140,000 Americans alone have been injured by Vioxx), Merck recalled the drug. Since that day, Merck's stock has dropped rapidly in value wiping out tens of billions of dollars in market value. This has adversely affected both shareholders and pension plan participants. Merck's credit rating has also continued to drop since analysts believe that Merck is refusing to make provisions for Vioxx related liabilities that could be as high as $55 billion according to some estimates.

Merck is also being investigated by The US Department of Justice and certain Congressional committees. Hearings are also scheduled by the FDA and European Medicines Agency (EMEA) in coming weeks to assess if all Vioxx-type Cox-2 inhibitor drugs, for example, Celebrex, Bextra, Prexige, Arcoxia, etc. should be recalled.

According to Associated Press, as many as 700 lawsuits have been filed against Merck so far and the number of Vioxx plaintiffs is expected to rise to tens of thousands in coming months, making it the largest product liability class action lawsuit in America. A panel of federal judges met yesterday to consider where the lawsuits should be consolidated.

Recommended article: Litigators prepare Vioxx class action lawsuits against Merck

Tens of thousands Vioxx class action lawsuit plaintiffs

Number of Vioxx plaintiffs could reach into tens of thousands in the United States alone, according to attorneys who spoke to the press today. The attorneys were attending the first hearing regarding Vioxx class action lawsuits and how to proceed forward. (Related article: Vioxx class action lawsuits against Merck explode)

A panel of seven judges met in Fort Myers, Florida (USA) today to consider where the federal Vioxx class action lawsuits should be consolidated. As expected, Merck argued that all federal cases be placed under one jurisdiction because it will be easy for them. Merck has been actively seeking hearings in conservative courts that are historically friendlier to large corporations and hostile to victims. Merck attorney Norman C. Kleinberg suggested federal districts in Maryland, Indiana, Illinois and New Jersey are equipped to handle consolidation of the large number of complicated cases.

Good estimates are not available yet on the number of lawsuits filed against Merck since the recall of Vioxx in September, 2004. In its annual review earlier this week, Merck reported that as of Dec. 31, 2004, the company has been served or is aware that it has been named as a defendant in approximately 575 lawsuits, which include approximately 1,400 plaintiff groups alleging personal injuries resulting from the use of VIOXX. Some Vioxx attorneys say that the firm is purposely downplaying the number of lawsuits to hide the actual data from investors. The Associated Press research shows that there may be as many as 700 lawsuits. (Related article: Merck's aggressive approach to Vioxx lawsuits)

Considering that by conservative estimates, as many as 140,000 Americans alone may be injured by Vioxx, the number of law suits against Merck could run into tens of thousands on a global basis. The main reason is that attorneys are still collecting information from Vioxx victims. The process of identifying victims has just begun outside the United States.

The judicial panel that met today to consider multi-district litigation (MDL) matters is expected to announce a decision in a few weeks.

In the meantime, Vioxx attorneys have been actively reaching out to victims. Lawyers also met in Philadelphia to develop a strategy for what many analysts expect would be the "mother of all class action lawsuits" if President Bush does not succeed in taking away the rights of American people to sue drugmakers for making lethal drugs like Vioxx.

While Merck has vowed to vigorously fight all lawsuits and has not admitted that it is responsible for even one death, Vioxx attorneys have gotten a lot of help from scientists and researchers who have come up with damning evidence against Merck: that it advertised the drug to patients who did not gain to benefit from it at all, that Merck hid data that linked Vioxx to heart diseases, and that it trained its employees to dodge questions from doctors about the safety of Vioxx. While Merck appears to be in denial about its Vioxx liabilities, most analysts estimate these to be somewhere between $18 billion and $55 billion. Moody's Investor Service today again cut the long-term debt rating of Merck saying that is highly concerned about the total litigation costs related to Vioxx. (Related article: Vioxx litigation lowers Merck credit rating)

Similar lawsuits are being filed against Merck competitor Pfizer, the maker of Celebrex and Bextra, both of which have been found to have serious side effects on the heart. Analysts expect that Pfizer will face the same fate as Merck though Pfizer CEO Hank McKinnell still continues to tout the safety of Celebrex despite several studies that show otherwise. Both the FDA and the EMEA are reviewing if Celebrex and/or Bextra should be recalled. McKinnell has been quoted as saying in recent days that Celebrex sales will rebound soon after FDA will leave Celebrex on the market with just a warning.

Recommended article: FDA should have never approved Vioxx

140000 Americans injured by Vioxx

The arthritis drug Vioxx could have caused an estimated 88,000–140,000 excess cases of serious coronary heart disease in the US since its launch in 1999, concludes a study published online by The Lancet. We had reported this earlier as well when Dr. David Graham, in an interview with the Financial Times, had mentioned that he was revising his Vioxx injury estimate upwards. (Related article: Merck shows no sympathy for Vioxx victims)

Dr. Graham, an expert at the FDA, and his team analyzed data from 1·4 million people in California who had used NSAIDs from the beginning of 1999 to September 2004. Patients had received various NSAIDs, including celecoxib or Celebrex (around 40,000 users), ibuprofen (just under a million users), naproxen or Aleve (around 43,5000 users), and rofecoxib or Vioxx (around 27,000 users). The investigators found that 8,143 individuals had serious coronary heart disease, 1508 of which had sudden cardiac death. Each case was matched by age and gender to four controls to enable a comparison of coronary heart disease risk among people taking Vioxx and users of other NSAIDs.

People taking Vioxx had a 34% higher chance of coronary heart disease when compared with people who used other NSAIDs. Coronary heart disease was 1·6 times more likely among people currently taking standard-dose Vioxx compared with those currently taking celecoxib (Celebrex) and 3·6 times more likely among high-dose users. The study also found that people taking naproxen (Aleve) had a 14% increased risk of coronary heart disease compared with other NSAIDs. Previous studies have suggested that naproxen protects against coronary heart disease. (Related article: Celebrex, Bextra recall demanded)

Dr Graham comments: “An estimated 88,000-140 000 excess cases of serious coronary heart disease probably occurred in the USA over the market life of rofecoxib (Vioxx). The US national estimate of the case-fatality rate (fatal acute myocardial infarction plus sudden cardiac death) was 44%, which suggests that many of the excess cases attributable to rofecoxib use were fatal. In the future, when trials show that a new treatment confers a greater risk of a serious adverse effect than a standard treatment, we must be much more careful about allowing its unrestrained use.” (Related article: FDA should have never approved Vioxx)

In an accompanying commentary Simon RJ Maxwell and David J Webb (University of Edinburgh, UK) write that after the withdrawal of Vioxx increased attention will now focus on the cardiovascular safety of other COX-2 inhibitors (coxibs) like Celebrex, Bextra, Prexige, Arcoxia. Professor Webb concludes: “It now falls to the manufacturers, under the careful review of the regulatory authorities, to provide the evidence that this class of drugs is safe, if necessary including studies that directly address cardiovascular morbidity as a primary outcome. Indeed, the experience with coxibs underlines the need for full publication of all clinical trial data generated in support of newly licensed drugs.” (Related article: Safety of Celebrex, Bextra questioned)

As reported earlier, researchers have also concluded that Vioxx was often over-subscribed due to its aggressive marketing by Merck despite the fact that the drug offered no benefits to vast majority of patients and actually much worse side effects.

So far Merck has not taken any responsibility for deaths and injuries and continues to vigorously attack Vioxx victims. The company also does not accept that Vioxx was a killer drug. In fact, Merck forced one of its researchers to remove her name from a study (that was approved/funded by Merck) linking Vioxx to heart attacks and then criticized the findings, two of the scientist's colleagues say. It is no secret that Merck hid data about Vioxx and often attacked scientists and researchers if they came up with any form of evidence that Vioxx was killing people. Merck recalled Vioxx on September 30, 2004. In one case, it even threatened Gurkipal Singh, an adjunct professor of medicine at Stanford University when he started to study the side effects of Vioxx. Merck also hired paid consultants whose job was to write articles in medical journals and speak at conferences defending Vioxx without disclosing that they were being paid by Merck to do so. "Even after funding and agreeing with the design of the study, Merck publicly discredited our findings," Drs. Daniel Solomon and Jerry Avorn of Boston's Brigham and Women's Hospital wrote in this week's Archives of Internal Medicine in an editorial entitled "Coxibs, Science, and the Public Trust". (Related article: Why Merck did not recall Vioxx earlier?)

Naturally, Vioxx victims are incensed and have been filing class action lawsuits against Merck. In a related development, President Bush and Republicans are getting ready to take away the rights of American people to sue drugmakers when they make lethal drugs like Vioxx. While chances are small that the bill will be passed but it seems that there is a small possibility that American Vioxx victims may be denied justice because the pharmaceutical industry is in bed with the Bush administration.

Recommended article: Complete history of Vioxx and its recall by Merck

Vioxx litigation update provided by Merck

This morning, Merck & Co.,Inc. announced its full-year results for 2004 and, as expected by analysts, it has been seriously hurt by recall of Vioxx. While the detailed statement from Merck is at the bottom, here is a summary of what Merck is saying:

• Class action lawsuits by Vioxx victims have exploded and trials will begin in the first half of 2005. (Related article: Vioxx MDL hearings scheduled)
• Merck shareholders and participants in its retirement plans are also suing Merck since the stock has taken a strong beating since Vioxx recall.
• Merck is also being investigated by several federal agencies.
• Merck continues to be in denial that it will have to pay even a penny to Vioxx victims. The company has not made any provisions for its Vioxx liabilities and has allocated just $604 million reserve solely for future legal defense costs for VIOXX litigation.
• Merck's insurers are already backing off from some of the insurance commitments. Due to the enormous liabilities that Merck might face (analysts estimates range from $18 billion to $55 billion in Vioxx lawsuits alone), Merck admits that there are ongoing disputes with insurance companies.
• Merck also admits that since it is not making any provisions for Vioxx liabilities and if it has to pay Vioxx victims in line with what Vioxx attorneys are demanding, it will essentially go out of business.

Following are parts of the statement released by Merck that relates to Vioxx litigation update:

As previously disclosed by Merck, federal and state personal injury lawsuits involving individual claims, as well as several putative class actions have been filed against the company with respect to VIOXX. As of Dec. 31, the company has been served or is aware that it has been named as a defendant in approximately 575 lawsuits, which include approximately 1,400 plaintiff groups alleging personal injuries resulting from the use of VIOXX. Certain of these lawsuits include allegations regarding gastrointestinal bleeding, cardiovascular events, thrombotic events or kidney damage. The company has also been named as a defendant in approximately 70 putative class actions alleging personal injuries or seeking:

1. Medical monitoring as a result of the putative class members' use of VIOXX,
2. Disgorgement of certain profits under common law unjust enrichment theories, and/or
3. Various remedies under state consumer fraud and fair business practice statutes, including recovering the cost of VIOXX purchased by individuals and third-party payors such as union health plans (all of the actions discussed in this paragraph are collectively referred to as the "VIOXX Product Liability Lawsuits").

The actions filed in the state courts of California and New Jersey, respectively, have been transferred to a single judge in each state for coordinated proceedings. In addition, the company has filed a motion with the Judicial Panel on Multidistrict Litigation (MDL) seeking to transfer to a single federal judge and consolidate for pretrial purposes all federal cases alleging personal injury and/or economic loss relating to the purchase or use of VIOXX; several plaintiffs in certain VIOXX Product Liability Lawsuits pending in federal court have made similar requests. The hearing on these motions will be held on Jan. 27.

Also as previously disclosed, in addition to the VIOXX Product Liability Lawsuits, a number of purported class action lawsuits have been brought naming as defendants the company and several current or former officers of the company, and alleging that the defendants made false and misleading statements regarding VIOXX in violation of the federal securities laws (the "VIOXX Securities Lawsuits"). As of Dec. 31, 14 VIOXX Securities Lawsuits have been filed. In addition to the VIOXX Securities Lawsuits, as previously disclosed, shareholders have brought derivative lawsuits against the company. As of Dec. 31, six such lawsuits have been filed.

In addition, the company has received a demand from two shareholders that the Board take legal action against Raymond V. Gilmartin, chairman, president and chief executive officer, and other unspecified individuals for allegedly causing damage to the company through the allegedly improper marketing of VIOXX. Also, as previously disclosed, lawsuits asserting claims under the Employee Retirement Income Security Act (ERISA) have been brought against the company. As of Dec. 31, 10 such lawsuits have been filed. The company has filed a motion with the Judicial Panel on Multidistrict Litigation to transfer to a single federal judge and consolidate for pretrial purposes all federal lawsuits discussed in this paragraph (collectively, the "VIOXX Shareholder Lawsuits" and together with the VIOXX Product Liability Lawsuits and the lawsuits discussed in the next paragraph, the "VIOXX Lawsuits"). The hearing on this motion will be held on Jan. 27. (Related article: Merck board of directors decides to review Vioxx recall process)

In addition to the lawsuits discussed above, the company has been named as a defendant in actions in various countries in Europe, Canada, Brazil, Australia and Israel related to VIOXX.

Based on media reports and other sources, the company anticipates that additional VIOXX Lawsuits will be filed against it and/or certain of its current and former officers and directors in the future. (Related article: Vioxx recall lawsuits outside the United States)

As previously disclosed, there are investigations concerning VIOXX currently being conducted by the Securities and Exchange Commission, the U.S. Department of Justice and certain Congressional committees. Also, the District Attorney's Office in Munich, Germany has notified the company's subsidiary in Germany that it has received complaints and commenced an investigation in order to determine whether any criminal charges should be brought in Germany concerning VIOXX (together with the previously mentioned investigations, the "VIOXX Investigations").

Also as previously disclosed, the company has product liability insurance for claims brought in the VIOXX Product Liability Lawsuits of up to 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. Certain of the company's insurers have reserved their rights to take a contrary position with respect to certain coverage and there could be disputes with insurers about coverage matters. The company currently believes that it has at least approximately $190 million of Directors and Officers insurance coverage for the VIOXX Securities Lawsuits and VIOXX Derivative Lawsuits, and at least approximately $275 million of insurance coverage for the VIOXX ERISA Lawsuits. Additional insurance coverage for these claims may also be available under upper-level excess policies that provide coverage for a variety of risks. There may be disputes with insurers about the availability of some or all of this insurance coverage. 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 losses, if any. (Related article: Litigators prepare for Vioxx class action lawsuits against Merck)

The company currently anticipates that one or more of the VIOXX Product Liability Lawsuits may go to trial in the first half 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. The company has established a reserve of $675 million solely for its future legal defense costs related to the VIOXX Lawsuits and the VIOXX Investigations. This reserve is based on certain assumptions and is the minimum amount that the company believes at this time it can reasonably estimate will be spent over a multi-year period. In accordance with GAAP and consistent with Merck's practice, the company significantly increased the reserve when it had the ability to reasonably estimate its future legal defense costs for the VIOXX litigation based on both actual costs incurred as well as the development of its legal defense strategy and structure in light of the expanded scope of the litigation. 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 litigation. 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.

Recommended article: Merck vows to mount a strong defense in Vioxx class action lawsuits

Merck shows no sympathy for Vioxx victims

Merck & Co., Inc. today announced that earnings per share for 2004 were hurt due to the company's Sept. 30 voluntary worldwide withdrawal of VIOXX. In addition, 2004 results include an additional $604 million reserve recorded in the fourth quarter solely for future legal defense costs for VIOXX litigation. The company has not established any reserves for any potential liability relating to the VIOXX litigation. The results were also negatively affected by approximately $700 to $750 million in foregone sales in the fourth quarter related to the VIOXX withdrawal.

With the charge taken in the fourth quarter, the company's reserve solely for its future legal defense costs related to the VIOXX litigation is now $675 million. This reserve is based on certain assumptions and is the minimum amount that the company believes at this time it can reasonably estimate will be spent over a multi-year period. Or in other words, Merck is not reserving any funds for its Vioxx liabilities that analysts estimate could be as high as $55 billion. (Related article: Merck's Vioxx liabilities)

"We have stated previously that we intend to defend these lawsuits vigorously," said Kenneth C. Frazier, Merck Senior Vice President and General Counsel. "This reserve is consistent with our commitment to defend the company." This is a line that the company has been repeating since the recall of Vioxx and it has definitely not pleased Vioxx victims and family members of those who passed away after taking Vioxx. According to latest estimate from Dr. David Graham, the FDA expert, as many as 140,000 Americans alone may have been injured by Vioxx. (Related article: Merck continues its ferocious attack on Vioxx victims)

"As a company, we are moving beyond the VIOXX withdrawal. We are focused on renewing growth and accelerating the process of change to position Merck to best meet the demands of the market and the challenges of the environment," said Merck Chairman, President and Chief Executive Officer Raymond V. Gilmartin. "We continue to streamline our business processes, allocate resources to the areas of highest potential growth and accelerate the speed at which we develop products. We are also driving growth through new and established products, new indications and formulations, and clinical trials that bolster our products' safety and efficacy profiles. In addition, our financial strength supports our ability to grow both internally and through licensing agreements and targeted acquisitions."

In other words, the company does not care that tens of thousands of people are dead worldwide. Rather than showing any sympathy for the dead and kind words for the injured, the words of Gilmartin have a tone that indicate a callous attitude towards human life in general. It almost appears that Gilmartin is irritated that Vioxx victims should bother him for deaths and injuries caused by Merck. There are reports that the pharmaceutical industry is actively helping the Bush administration to change the laws of the United States in the current session of Congress (the bill has been declared as one of the top three priorities of Republicans along with privatization of Social Security) so that no matter how many Americans are killed by lethal drugs, Americans will not be able to bring the drugmaker to justice. (Related article: Rights of Vioxx victims to sue Merck may be taken away soon by the Bush administration)

In October 2003, Merck announced plans to eliminate 4,400 positions as part of a cost-reduction initiative which is now complete. As of Dec. 31, the company had eliminated 5,100 positions, as the company identified additional opportunities to eliminate positions and reduce costs. Most of the additional eliminations came from contractor positions. In 2005, this action is expected to lower the company's annual payroll and benefit costs by approximately $300 million without impacting either key productivity initiatives or Merck's ability to meet its business objectives. Merck has also redeployed sales representatives that had previously supported VIOXX to capitalize on opportunities to grow its in-line products and support upcoming launches.

Recommended article: FDA should have never approved Vioxx

Vioxx MDL hearing scheduled for January 27

This Thursday, the largest class action lawsuit in the history of mankind will begin. On January 27, downtown Fort Myers will engage a sea of black limousines and an army of attorneys as they make their way up the steps of the United States Courthouse and Federal Building, where seven federal judges, flown in from around the country, will form a multi-district litigation (MDL) panel in the Vioxx legal proceedings against Merck & Co.

Fort Myers is no stranger to this level of excitement. In 1997, the MDL proceedings for the nationwide Fen-Phen trial against Wyeth were also held here. At that time, Viles & Beckman, P.A., the local Fort Myers law firm, was highly involved in the trial, representing hundreds of Fen-Phen victims, and fortunate enough to be named lead counsel for the state of Florida.

On January 27, Viles & Beckman, P.A. will again be monitoring the pretrial proceedings closely, the outcome of which could prove crucial in determining the course of future Vioxx cases against the pharmaceutical giant. They currently have close to 1,000 signed Vioxx recall cases, and have an excellent chance of being named lead counsel for the state of Florida once again, due to their extensive expertise in defective drug product litigation.

The class action lawsuit filed by Viles & Beckman, P.A. asks Merck for free ongoing health monitoring and care for those who have taken Vioxx in addition to monetary compensation for medical bills, punitive damages, and pain and suffering.

Recommended article: How to find Vioxx attorneys?

Celebrex, Bextra recall demanded

Since the recall of Vioxx, there has been a lot of discussion if other Cox-2 drugs like Celebrex and Bextra should be recalled. While the maker of both drugs on the market, Pfizer, has been warned by FDA for misleading ads and has been sued by many plaintiffs who argue that the company did not disclose the adverse side effects of the drugs, the company continues to stand by the safety of the drugs. (Related article: Pfizer sued by Celebrex, Bextra patients)

Not everyone is convinced though. Doctors are asking that Cox-2 drugs not be prescribed in most cases till a more accurate safety profile is developed. The European Medicines Agency (EMEA) has asked Pfizer for more data on the side effects of Celebrex and Bextra. Pfizer's argument about the safety of Celebrex and Bextra has not been found to be convincing when researchers from the University of Chicago and Stanford University School of Medicine found that most of the growth in COX-2 use between 1999 and 2002 occurred in patients at little risk for side effects from the drugs COX-2s were developed to replace. They found that:

• Vioxx was more expensive than over-the-counter pills but no more effective.
• Had adverse side effects that over-the-counter painkillers did not have.
• Was heavily marketed to patients who did not gain to benefit from it.

Now a consumer rights group, Public Citizen, has petitioned the U.S. Food and Drug Administration (FDA) to immediately remove both Celebrex and Bextra, from the market because they increase the risk of heart attacks in patients. The group also urged the FDA to cancel plans to approve two other drugs in the same class. In 2004, more than 23.9 million prescriptions were filled in the United States for Celebrex; 12.9 million for Bextra. (Related article: Pfizer highlights the risks of recall of Celebrex and Bextra)

“If a drug offers no unique benefit compared to other drugs for treating the same problem (in this case arthritis and pain) but subjects patients to a unique risk, it must be removed from the market,” says the 12-page petition. The findings from the study by G. Caleb Alexander, M.D., M.S., instructor of medicine and a member of the MacLean Center for Clinical Medical Ethics at the University of Chicago and Randall S. Stafford, M.D., Ph.D., associate professor and Director of the Program on Prevention Outcomes and Practice at Stanford University support this argument. They found that the COX-2 inhibitors (e.g. Vioxx, Celebrex, Bextra, etc.) are no more effective in relieving pain than aspirin, ibuprofen, or any of the traditional non-steroidal anti-inflammatory drugs ( NSAIDs ), but they cause fewer of the gastrointestinal side effects that often trouble long-term high-dose NSAID users. In exchange for reduced GI risk, however, they cost 10 to 15 times as much as the drugs they replaced. The researchers also found that most people who received prescriptions were at very low or low risk for GI bleeds and thus did not really need a COX-2 inhibitor. (Related article: Vioxx approval may have been a mistake by the FDA)

Despite the guidelines, 1.7 million, or 12 percent of patients at very low risk, received COX-2 prescriptions in 1999. That number increased to 7.6 million or 40 percent of very low risk patients by 2001 before declining slightly in 2002. At the same time, 6.8 million patients, or 40 percent of those at low risk, got COX-2 drugs in 1999, which increased to 17.6 million or 66 percent of low risk patients in 2002. (Related article: Direct-to-consumer advertising for Vioxx and Celebrex)

Public Citizen’s petition on Celebrex and Bextra examines the results of 14 randomized control trials involving the five COX-2 inhibitors, as well as other published and unpublished scientific information. The other two COX-2 inhibitors are Prexige (lumiracoxib) and Arcoxia (etoricoxib), neither of which has been approved for sale by the FDA in the United States but these drugs are sold to citizens of other countries. The petition says that clinical studies suggest these drugs exhibit the same cardiovascular toxicity as Vioxx, Celebrex and Bextra, and should not be approved.

“The Food and Drug Administration should immediately ban the sale of Celebrex and Bextra, which put millions of people, many of them elderly, at risk of heart attack,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “These drugs are not only more expensive and more dangerous than older, safer pain relievers, they are no better at protecting the gastrointestinal tract,” Alexander agrees. He says, "What we saw was widespread, rapid adoption of an interesting and promising but expensive and largely untested medication by millions of people with little or nothing to gain from long-term use. The findings demonstrate the challenge of limiting innovative therapies to the settings in which they are initially targeted and maximally cost-effective."

Recommended article: FDA should have never approved Vioxx

Litigators prepare for class action lawsuits against Merck

LexisNexix Professional Development Center along with Mealey Publications & Conference Group organized a Vioxx Litigation Conference this week to help Vioxx attorneys prepare for forthcoming trials of hundreds of class action lawsuits. The conference was chaired by Andy D. Birchfield, Jr., Esq., Beasley, Allen, Crowe, Methvin, Portis & Miles, P.C., and Christopher A. Seeger, Esq., Seeger Weiss LLP.

Merck has vowed to aggressively fight all Vioxx class action lawsuits and in statements made through its attorneys has refused to settle any cases out of court arguing that Vioxx victims have no case against the company. Many analysts also expect that Bush administration may be successful in taking away the right of American people to sue a drugmaker even when it manufactures and markets a killer drug.

While it is not easy to estimate Merck's liabilities in Vioxx litigation, analysts estimate that it could be as high as $38 billion though one analyst has even come up with a $55 billion estimate. Vioxx litigation, like any other product liability case, is not going to be easy since attorneys will have to prove that Merck knew of the risks and hid them from the FDA, physicians, and patients. Lawyers claim that they now have enough evidence to prove that by presenting emails and training material used by Merck to teach its sales reps to dodge tough questions from doctors about the safety of Vioxx. Merck, on the other hand, is planning to prove in each case that the health of each individual rather than Vioxx was a cause of injury or death. (Related article: Merck's aggressive approach to Vioxx class action lawsuits)

That is why this conference served as a training seminar for attorneys working on Vioxx cases. Some of the topics covered include:

John Lehmann, PhD, Pharmacologist & President, DrugIntel discussed the pharmacology of Vioxx answering questions like: What is Vioxx and how do its components allegedly contribute to heart problems? Do all COX-2 inhibitors interfere with enzymes that can help to avoid cardiovascular disease? If a patient stops taking Vioxx, is the potential threat over? (Related article: Vioxx found to be the most dangerous drug in the Cox-2 category)

Ira J. Gelb, MD, Clinical Professor and Director of Clinical Programs, Charles E. Schmidt School of Biomedical Science, Florida Atlantic University and Paul Rheingold, Rheingold Valet Rheingold Shkolnik & McCartney discussed cardiology issues associated with the use of Vioxx addressing such issues as Mechanisms of a heart attack/stroke, medical perspective on the clinical studies, and tough call cases.

Barry Hill, Hill Toriseva & Williams and David Buchanan, Seeger Weiss provided a legal perspective on the science and clinical medical studies.

Of course no seminar could be complete without discussing the role of FDA, which has consistently sided with Merck in the Vioxx recall controversy and has refused to take responsibility for the deaths of thousands of Americans even though its own expert Dr. David Graham has argued that it is the FDA that is ultimately responsible. Along with the White House that owes a lot of favors to the drug industry including to Merck and its CEO Raymond Gilmartin, even the FDA is populated with drug industry insiders. Therefore, the role played by the administration and the FDA will be critical in Vioxx trials.

A series of presentations were also made with regards to theories of liability and defense, what is the criteria to consider when evaluating a potential client and case evaluation, and status of litigation in different states. (Related article: Vioxx drug liability - a new mass tort)

Related to Vioxx class action lawsuits are the rapidly exploding lawsuits against Pfizer, the maker of Vioxx competitor drugs Celebrex and Bextra, both of which have been found to have serious adverse side effects. Shanin Specter of Kline & Specter, one of the leading law firm working on Vioxx lawsuits discussed the potential for litigation expanding beyond Vioxx to Celebrex, Bextra, and other Cox-2 drugs.

Recommended article: Arthritis patients want to sue makers of Vioxx, Celebrex, and Bextra

Vioxx patients misled by Merck advertising

In a finding that could have significant impact on Vioxx litigation, researchers at Stanford University have found that Vioxx was prescribed to patients who were unlikely to benefit much from this drug but would be subject to a higher risk of heart attacks and other serious side effects.

How could Merck do this? Through slick, direct-to-consumer advertising about Vioxx that talked only of the benefits and never highlighted the risks. In other words, the researchers find that Cox-2 drugs are not necessarily better at treating pain than nonsteroidal anti-inflammatory drugs (or over-the-counter painkillers that cost pennies), and people at low risk for stomach bleeding got no real benefit from using drugs like Vioxx and Pfizer's Celebrex and Bextra (which continue to remain on the market), yet were exposed to the drugs' increased risk of heart attacks and strokes and paid a lot more. (Related article: Recall prospects for Celebrex and Bextra rise after side effects found)

While direct-to-consumer advertising for Cox-2 drugs is on hold for the time being (Vioxx has been recalled, and in an agreement with the FDA, Pfizer has stopped all advertising for Celebrex and Bextra till a thorough review of the safety of the drugs is completed in February), it is important to recall that over the life of Vioxx, Celebrex, and Bextra, hundreds of millions of dollars were spent on advertising on what are essentially lifestyle drugs (ones that do not cure a disease but improve quality of life). Pfizer actually got so aggressive with marketing of Celebrex and Bextra (particularly after recall of Vioxx) that FDA issued a warning earlier this month about its misleading ads. (Related article: Pfizer warned by FDA on misleading Celebrex and Bextra ads and Celebrex and/or Bextra recall likely?)

Dr. Eric Topol, world-renowned cardiologist and an authority on side effects of painkillers on the heart, writes in the Journal of American Medical Association, "...but valdecoxib (Bextra) and celecoxib (Celebrex) have never been definitively confirmed to protect against gastrointestinal complications. While coxib superiority over NSAIDs for relief of arthritic pain has not been shown, many individual patients report pain relief with a coxib but not an NSAID. With the considerably higher cost, marginal efficacy, and known cardiovascular risks of the remaining agents on the market, valdecoxib and celecoxib, it would seem prudent, at the least, to avoid using these agents as first-line therapy." (Related article: FDA should have never approved Vioxx)

Doctors generally do not appreciate direct-to-consumer advertising since it forces them to prescribe drugs that are not always the best for their patients, and in many cases, they have to prescribe a drug when no prescription is necessary (in other words, over-prescription occurs). United States is one of the only two countries in the world to allow direct-to-consumer advertising for prescription drugs. Any discussion to ban this advertising has been met with howls of protest from drug companies and advertising agencies. Dr. Topol has called for a complete ban on direct-to-consumer advertising so that doctors can decide what is best for their patients rather than being told by (mostly clueless, poorly informed) patients what drug they want. He says, "The combination of mass promotion of a medicine with an unknown and suspect safety profile cannot be tolerated in the future. An aggressive position going forward is necessary not only for ensuring the safety of prescription medicines but also to restore a solid foundation of public trust."

Recommended article: Right advertising strategy for prescription drugs

Safety of Celebrex, Bextra questioned by Europeans

Since the recall of Vioxx in September, 2004, and subsequent release of reports pointing out serious adverse side effects of Celebrex and Bextra, drug approval agencies worldwide have been looking at the complete class of Cox-2 drugs to assess if these should be recalled.

In that respect, two agencies are extremely important because their decisions will not only be followed by other agencies, it will impact the two largest markets (United States and European Union) for Cox-2 drugs like Celebrex and Bextra. (Related article: Bextra safety doubted in three major studies)

European Medicines Agency (EMEA) is a decentralized body of the European Union with headquarters in London. It coordinates the evaluation and supervision of medicinal products throughout the European Union. The Food and Drug Administration (FDA) is a similar agency in the United States. (Related article: FDA warns Pfizer on misleading ads for Celebrex and Bextra)

As part of the ongoing review of COX-2 inhibitors, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) held hearings with Pfizer (for celecoxib or Celebrex, parecoxib or Dynastat/Rayzon/Xapit and valdecoxib or Bextra), Merck Sharp & Dohme (for etoricoxib or Arcoxia) and Novartis (for lumiracoxib or Prexige) on 18 January 2005.

Further to its assessment of data submitted on celecoxib, the Committee requested further clarifications and analyses, in particular of data from the Adenoma Prevention with Celecoxib (APC) and Prevention of Spontaneous Adenoma Polyps (PreSAP) studies. (Related article: Pfizer announces recall risks for Celebrex and Bextra)

The review includes Onsenal (celecoxib), which is used in the orphan (rare) indication in the treatment of adenomatous intestinal polyps in familial adenomatous polyposis. This is a similar treatment area as looked at in the APC and PreSAP celecoxib studies and also the APPROVe study that led to the withdrawal of Vioxx (rofecoxib). Following discussions with the Committee, Pfizer has agreed not to launch Onsenal in the European Union pending finalization of the assessment.

Data on other COX-2 inhibitors (etoricoxib, lumiracoxib, parecoxib and valdecoxib) are currently being assessed. The CHMP will continue its discussions on the review at its next meeting on 14-17 February 2005. The FDA will be conduct a series of public hearings on the Cox-2 drugs from 16-18 February.

Recommended article: Celebrex, Bextra class action lawsuits explode over safety concerns

Celebrex, Bextra class action lawsuits explode

Since the recall of Vioxx by Merck, the company has been targeted by victims through hundreds of class action lawsuits. While no accurate estimates are available on a global basis, FDA scientist Dr. David Graham estimates that as many as 139,000 Americans have suffered casualties from taking Vioxx. Despite the fact that Merck has mounted an aggressive attack on Vioxx victims and President Bush is proposing changing the laws of the United States to deny Americans the right to sue a drugmaker even when it markets a deadly drug, analysts expect that Merck may have as much as $38 billion in Vioxx liabilities. The firm has made no provision for these liabilities and may need to file for bankruptcy as the lawsuits move forward. (Related article: Vioxx recall and class action lawsuits hurt Merck's financials)

There is agreement among experts that since Pfizer has chosen to follow the same strategy as Merck, if additional data comes out that Celebrex and/or Bextra actually hurt patients or if FDA recommends that Celebrex and/or Bextra be recalled, Pfizer will face similar class action lawsuits. In fact, many experts believe that since Pfizer has continued to stand behind the safety of both Celebrex and Bextra, any of these events will be catastrophic for the company. In addition to that, the firm has attracted class action lawsuits from shareholders and other investors who argue that due to the problems with Celebrex and Bextra, Pfizer stock has dropped in value. (Related article: Celebrex/Bextra class action lawsuits against Pfizer follow the Vioxx class action lawsuits approach)

Below is an update provided by Pfizer on class action lawsuits related to Celebrex and Bextra":

"As previously reported, in 2003, several purported class-action complaints were filed in the U.S. District Court for the District of New Jersey by persons who claim to have been purchasers of publicly traded securities of Pharmacia during the period from April 17, 2000 through August 22, 2001 (the "Purported Class Period"). Named as defendants in the actions are Pharmacia, Pfizer, and certain former officers of Pharmacia. The complaints allege that the defendants violated federal securities laws by misrepresenting the data from a study concerning the efficacy of the gastrointestinal effects of Celebrex. These cases have been consolidated for pre-trial purposes. Plaintiffs purport to represent a class of all persons who purchased Pharmacia securities during the Purported Class Period and were damaged as a result of the decline in the price of Pharmacia's securities allegedly attributable to the misrepresentations. Plaintiffs seek damages in an unspecified amount.

As previously reported, Pfizer is a defendant in a number of product-liability suits in various federal and state courts alleging injury as a result of the use of Celebrex, including a purported class action filed in 2001 in the U.S. District Court for the Eastern District of New York. Additional suits, including purported class actions, alleging injury as the result of the use of Celebrex and Bextra have been filed in late 2004 and early 2005.

A number of purported class actions recently have been filed against Pfizer in the U.S. and in Canada alleging consumer fraud as the result of false advertising of Celebrex and Bextra and the withholding of information from the public regarding the alleged safety risks associated with Celebrex and Bextra. The plaintiffs seek damages in unspecified amounts for economic loss.

As previously reported, we received requests for information and documents from the U.S. Department of Justice and a group of state attorneys general concerning the marketing of Bextra and Celebrex. The agencies have also recently sought information and documents relating to the safety of both products. The Company is providing the information and documents sought. (Related article: FDA warns Pfizer on misleading Celebrex and Bextra ads)

Recently, a number of actions, including purported class actions, were filed against Pfizer and certain current and former officers, directors, and employees of Pfizer. These actions were brought in various federal and state courts, with the largest number being filed in the U.S. District Court for the Southern District of New York. These actions include:

1. Several class-action complaints alleging that Pfizer and certain officers violated federal securities laws by misrepresenting the safety of Celebrex and Bextra; (Related article: Vioxx and Celebrex direct-to-consumer advertising to be blamed for injuries)
2. Several shareholder derivative actions alleging that certain of Pfizer’s current and former officers and directors breached fiduciary duties by causing the Company to misrepresent the safety of Celebrex and, in certain of the cases, Bextra; and
3. Several purported class actions filed by persons who claim to be participants in the Pfizer Savings Plan, alleging that Pfizer and certain officers, directors, and employees of the Company violated certain provisions of the Employee Retirement Income Security Act of 1974 (“ERISA”) by selecting and maintaining Pfizer stock as an investment alternative when it allegedly no longer was a suitable or prudent investment option."

Recommended article: Arthritis patients rebel against makers of Vioxx, Celebrex, and Bextra

Pfizer highlights risks of recall of Celebrex, Bextra

Since the recall of Vioxx in September 2004, there has been a lot of concern among physicians and patients about the safety of Cox-2 class of drugs. Dr. Eric Topol, renowned cardiologist and an early critic of Vioxx, writing in the Journal of American Medical Association (JAMA) says, "...there are major concerns about how an entire drug class has gone awry with respect to unleashing significant cardiovascular hazard. A "house of cards" is defined as a flimsy situation that is in danger of collapsing or failing. From the outset, the coxib class of medicines seemed destined for potential collapse. This is so poignantly clear for an indication such as arthritis, which is one of the most common conditions requiring medication."

Responding to the concerns and recognizing that there are as many as 139,000 casualties from Vioxx alone, FDA is reviewing the whole Cox-2 class at its meeting next month. Agencies in other parts of the world are not only doing their own reviews, they are also looking at the hearings by the FDA. Whatever the FDA does will have a serious impact on what other agencies do. Most experts agree that if FDA recommends that Celebrex and/or Bextra be recalled, then other agencies will simply follow suit. (Related article: Vioxx recall makes drug agencies worldwide more careful)

This has raised a lot of concern among Pfizer shareholders. According to latest financial statistics released by Pfizer, Celebrex ($3.3 billion) and Bextra ($1.3 billion) together accounted for $4.6 billion in sales or approximately 10% of its overall sales. In other words, if the FDA does anything to jeopardize this revenue stream and the resulting class action lawsuits from Celebrex and Bextra patients will cripple Pfizer. Pfizer addressed the concerns of its shareholders in a statement released today:

"In light of recently released cardiovascular-safety data from several long-term trials in non-arthritis and non-pain indications and other information about COX-2-specific inhibitors and a non-selective non-steroidal anti-inflammatory drug, the FDA announced that it will analyze the available information on these medicines (including Celebrex and Bextra) to determine whether additional regulatory action is appropriate.

The FDA Advisory Committee meeting will take place February 16-18. We will be participating in the Advisory Committee meeting, and we look forward to a reasoned scientific discussion in which we will provide data in support of our belief that Celebrex and Bextra present a cardiovascular risk profile comparable to that of non-selective non-steroidal anti-inflammatory drugs and are important therapeutic options. (Related article: Pfizer provides safety update on Celebrex and Bextra)

Of course, we do not know what the Advisory Committee will recommend to the FDA, what actions the FDA may take after receiving those recommendations, or the timing of these events. If the FDA were to take actions that result in a significant loss of sales of Celebrex and/or Bextra, this could have a material adverse impact on our results of operations, the timing of which would depend upon the period to which any such action was attributed."

Recommended article: FDA warns Pfizer on misleading Celebrex and Bextra advertisements

Pfizer provides safety update on Celebrex

As readers may recall, Celebrex has attracted a lot of attention in recent months. First, after the recall of Vioxx, Pfizer was successful in positioning it as an alternative to Vioxx and it received widespread praise from investors who were delighted with as much as $1 billion in sales in just three months after Vioxx was recalled on September 30, 2004. Then it received a lot of negative attention for adverse cardiovascular side effects of Celebrex. Early this year, FDA warned Pfizer for misleading Celebrex ads.

In its annual financial review this morning, Pfizer provided an update on where Celebrex stands right now. The company also announced that it will sponsor more resear