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Group, in a letter addressed to the acting commissioner of the FDA, writes that they have discovered the results of an unpublished randomized placebo-controlled study by Pfizer, finished more than four years ago, that showed a significantly increased rate (3.6-fold) of serious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 research to assess the safety profile of Celebrex in arthritis patients. The following is the statement released by Pfizer:

"In December 2004, three controlled prevention studies involving Celebrex were halted. These three studies provide preliminary but inconsistent information. More specifically, on December 16, 2004, Pfizer learned of new information concerning two of these studies—large, well-controlled cancer-prevention studies involving patients who took high doses of Celebrex. One study, sponsored by the National Cancer Institute and involving patients taking 400 mg/day and 800mg/day of Celebrex, showed an increase in overall cardiovascular events, such as heart attack, stroke, and death, compared to placebo.

The second study, sponsored by Pfizer and involving patients taking 400 mg/day of Celebrex, did not show an increased overall cardiovascular risk over placebo.

A third large, well-controlled Alzheimer's prevention study sponsored and conducted by the National Institute on Aging, a part of the National Institutes of Health, reported preliminary information on December 20, 2004. This third study had enrolled more than 2,400 patients over the previous 3½ years to determine if Celebrex 400 mg/day or Aleve (naproxen sodium) 440 mg/day were effective treatments to prevent the development of Alzheimer's disease in people at risk of developing this serious disease.

Preliminary safety results from the study indicated in part "an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen sodium when compared with those on placebo." No increased cardiovascular risk was seen in patients taking Celebrex relative to placebo. We believe these three studies require considerable additional analysis before any conclusions can be reached. (Related article: Pfizer refuses to recall Celebrex)

The results from the National Cancer Institute study noted above differ from the other two studies halted at about the same time and from the body of data that we and others have accumulated over time. Within this accumulated body of data, there were certain studies in which there was an increased percentage of specific cardiovascular events for patients taking Celebrex versus patients taking placebo or other drugs; in other studies, there was a decreased percentage of specific cardiovascular events.

The investigators of those studies determined at the time that the differences were not meaningful and did not establish an increased or decreased cardiovascular risk for Celebrex. All of this information was shared with appropriate regulatory authorities and will be further evaluated in the context of the ongoing regulatory review.

We will be sponsoring a major clinical study to further assess the cardiovascular profile of Celebrex in arthritis patients at high risk for cardiovascular disease."

Recommended article: FDA should not have approved Vioxx, a drug similar to Celebrex

Bextra safety update from Pfizer

Bextra is a pain relief drug often prescribed to arthritis patients and belongs to the family of COX-2 drugs that also include Celebrex and now recalled Vioxx. Bextra is made by Pfizer and has attracted a lot of attention since the recall of Vioxx and reports of adverse side effects in a few studies. (Related article: Bextra safety doubted in two studies)

Bextra, along with Celebrex, is under review by the FDA and other drug agencies worldwide. There is speculation that Bextra may be recalled.

In its review for the fiscal year 2004, Bextra maker Pfizer today provided the following update on cardiovascular safety of Bextra:

"We have announced that, in two trials in high-risk surgery known as coronary artery bypass graft (CABG), an increase in cardiovascular events was observed in the first two-arm trial, in which patients received Bextra in combination with parecoxib (an intravenous form of Bextra) compared to placebo. However, in a second three-arm trial, this same increase in cardiovascular events was seen only in the Bextra/parecoxib combination arm compared to placebo and not in the arm treating these patients with Bextra alone. (Related article: Pfizer warned by FDA on misleading Bextra ads)

In studies in general surgery, Bextra in combination with parecoxib showed no increased risk of thromboembolic events.

Bextra is not approved for use in surgical settings in the U.S. We will be conducting clinical studies to further assess the cardiovascular profile of Bextra in arthritis patients. Recently, working with the FDA, we changed the prescribing information for Bextra to include this information about the CABG studies as well as to provide other information about the cardiovascular safety of Bextra. The revision to Bextra’s prescribing information also added a black-box warning relating to serious skin reactions."

Recommended article: FDA recommends limited use of Bextra after Vioxx recall

Bextra safety doubted in two studied

There are two more studies published this week that show that not only Bextra, the alternative to Vioxx and one of the two Cox-2 drugs made by Pfizer, but the whole family of COX-2 drugs are dangerous. These findings are extremely important because the European Medicines Agency is reviewing the Cox-2 category of drugs this week and the FDA in the United States will be holding a similar meeting Feb 16-18, 2005. The Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committees of the FDA will discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines. Most experts have been demanding that FDA ask Pfizer to recall both Celebrex and Bextra, since they are similar to Vioxx, which has been linked to as many as 139,000 casualties in the United States alone. (Related article: Vioxx death estimate revised upward)

Bextra received a strong safety warning in early December 2004 when it was found that people treated with Bextra for pain were more likely to have problems such as heart attacks, strokes and blood clots in the legs or lungs. Then earlier this month Pfizer was warned by the FDA for misleading Bextra ads since the company made claims that were not substantiated by data, after the recall of Vioxx.

In two articles, published in Circulation, researchers from the University of Pennsylvania School of Medicine provide further evidence for the role of cyclooxygenases (COX) in heart-disease risk. In one, a statistical meta-analysis of two placebo-controlled trials, the COX-2 inhibitor Bextra elevated the combined incidence of heart attack and stroke three-fold in coronary artery bypass graft (CABG) surgery patients. In the second, the investigators found that a fat produced by COX-1 speeds hardening of the arteries in a mouse model of atherosclerosis, which may have implications for low-dose aspirin therapy in heart patients.

Six years ago Garret FitzGerald, MD, Director of the Institute for Translational Medicine and Therapeutics at Penn, raised the possibility that selective COX-2 inhibitors might predispose patients otherwise at risk for an increased incidence of heart attack and stroke. This proposal was based initially on his studies of how celecoxib (Celebrex) and rofeocoxib (Vioxx) worked in human volunteers. (Related article: Vioxx alternative Celebrex increases risk of heart attacks)

The first unequivocal evidence of this risk emerged with the Merck-sponsored APPROVe study of Vioxx, leading to withdrawal of the drug in September 2004. Evidence implicating a second member of the class, valdecoxib (Bextra) was presented by FitzGerald in a lecture at the American Heart Association (AHA) in November 2004. This work – a collaboration led by Curt Furberg of Wake Forrest University, along with Bruce Psaty of the University of Washington and FitzGerald – appears online January 17 in Circulation and in the January 25th print edition of the journal. (Related article: Vioxx found to be more dangerous than Celebrex)

In this first study, the researchers used a conventional statistical approach called meta-analysis to combine the findings of two trials to obtain a stronger estimate of the risk of heart attack plus stroke than is possible from looking at either trial alone. Their analysis suggests that the COX-2 inhibitor Bextra elevated the combined incidence of heart attack and stroke three-fold in the study population of CABG patients. (Related link: Bextra recall)

Two placebo-controlled trials of Bextra and parecoxib (Dynastat) were performed in patients undergoing coronary artery bypass graft surgery. These studies were sponsored by Pfizer, Inc. In both cases, intravenous Dynastat, which is converted to Bextra within minutes in the body, was given before oral dosing with Bextra. The first involved roughly 400 patients and dosing lasted 14 days. Concern was prompted by an apparent cardiovascular signal and the FDA did not grant approval to Dynastat, despite clear evidence of pain relief from the Dynastat/Bextra combination compared to placebo. A second, larger study was performed in which the dose of Bextra was reduced, as was the dosing period to 10 days. The figures from this study are now incorporated in a revised drug label for Bextra. (Related article: Alternatives to Vioxx not found to be safe)

This result is consistent with the original mechanism proposed by FitzGerald in 1999 that COX-2 inhibitors may be problematic for those at risk for heart disease. COX-2 is the main source of a fat – prostacyclin or PGI2 – which protects the heart from factors that activate the clotting system, harden the arteries, and raise blood pressure. “Although a clinical trial is a crude detection system for uncommon side effects, such as the cardiovascular risk from coxibs, we predicted that a signal would be detected faster and in smaller studies in patients with activated clotting systems,” says FitzGerald. “It is well known that this is true of coronary artery bypass graft surgery patients.” Studies of sufficient size and duration to detect the expected rates of cardiovascular events in arthritis patients have not been performed with Bextra.

While FitzGerald stresses that the emergence of a cardiovascular signal with a second COX-2 inhibitor rendered the argument for a class effect of the risk “compelling,” the early cessation of a placebo-controlled trial of celecoxib (Celebrex) in December 2004 by the National Cancer Institute (because of an excess incidence of heart attack and stroke) appeared to put the matter beyond dispute. (Related article: FDA recommends limited use of Celebrex and Bextra after Vioxx recall)

A related paper from the FitzGerald group also appears online in the same issue of Circulation. Karine Egan, PhD, a postdoctoral researcher in the FitzGerald lab, and colleagues at Penn and the Wistar Institute studied mice genetically prone to hardening of the arteries (atherosclerosis) and showed that another fat – thromboxane or TxA2, this time produced by COX-1 – accelerates atherosclerosis. Indeed, they showed a drug that blocks TxA2 slowed this process at its early stages, although it seemed ineffective once atherosclerosis was well established. “This is of particular interest, as low-dose aspirin prevents heart attack and stroke by blocking COX-1 formation of TxA2 in blood cells called platelets,” says FitzGerald. “Its effects or those of a TxA2 blocker on hardening of the arteries has never been studied well in humans.”

Egan and colleagues failed to detect a benefit from COX-2 inhibition in the atherosclerosis-prone mice, but they reasoned that a potential benefit might be masked by the effect of the drug. Although platelet COX-1 is the major source of TxA2, this fat can also be formed by COX-2 in cells called macrophages that invade the hardening vessel wall. Given what they had seen with the TxA2 blocker, FitzGerald’s group figured that they might need to add the TxA2 blocker to see the anti-inflammatory benefit of the COX-2 inhibitor.

Adding the COX-2 inhibitor not only failed to add to the beneficial effects of the TxA2 blocker, it caused disturbing changes in the makeup of the atherosclerotic plaques. “We were amazed,” states Egan. “Addition of the COX-2 inhibitor caused changes that, if they occurred in humans, would result in a loss of stability of the plaque, making it more likely to rupture and activate clotting, causing heart attack or stroke.”

“We must always be cautious projecting the results of studies in mice to clinical outcomes in humans,” says FitzGerald. “While low-dose aspirin works by switching off TxA2, a TxA2 blocker might act in subtle, but importantly different ways. However, in so far as it mimics the effects of low-dose aspirin, these results would have disturbing implications for patients at high cardiovascular risk treated with aspirin and a coxib.”

FitzGerald adds: “The clear emergence of a cardiovascular hazard from COX-2 inhibitors in patients, the weak rationale for a study of their protective properties in the first instance, and now this evidence from mice would indicate to me that a trial in high-risk patients, such as that proposed for Celebrex is, at best, ill advised.”

This paper was funded in part by grants from the National Institutes of Health, Servier Laboratories, and Merck Research Laboratories. Servier and Merck had no influence on the design or interpretation of the studies, and the authors have no competing financial interests.

Recommended article: Post Vioxx recall; safe use of over-the-counter pain relief drugs

More alternatives to Vioxx and Celebrex offered

Since the recall of Vioxx and widespread speculation that both Celebrex and Bextra may be recalled as well in coming months, companies are trying to come up with alternatives to Cox-2 drugs. Supporters of Cox-2 inhibitors have been somewhat disappointed with recent studies that have shown an increased risk of heart attacks since the drugs were initially thought to be a revolution in pain relief for arthritis patients. (Related article: Pain relief drugs guide)

One company that we had highlighted recently is Dimethaid, based in Canada and maker of Pennsaid (Related article: Topical cream Pennsaid for pain relief for users of Vioxx, Bextra, and Celebrex). The growth of the drug has been remarkable in the last quarter of 2004 and reflects the establishment of Pennsaid in the Canadian market as well as the first shipment of product to its Portuguese partner Jaba Farmacêutica in advance of an official launch in early calendar 2005.

The company expects that Canadian Pennsaid sales will continue to grow based on:

• The recent publication of three Pennsaid clinical studies demonstrating safety and efficacy in prestigious Canadian and U.S. medical journals;
• A fully funded sales and marketing campaign led by our co-promotion partner Solvay Pharma;
• Arthritis patients' increasing need for treatment alternatives given the recent safety issues with COX-2s and traditional oral NSAIDS; (Related article: Aleve recall demanded after safety concerns)
• Establishing and enhancing relationships with key opinion leaders in the field of arthritis in Canada.

Another company that is working on an alternative to Vioxx and Bextra is BioDelivery Sciences International. The company recently applied its licensed and patented Bioral “nanocochleate” drug delivery technology to aspirin and traditional non-steroidal anti-inflammatories (NSAIDS) that are not selective COX-2 inhibitors. BDSI contracted with an independent testing laboratory to test its Bioral formulations of aspirin and other NSAIDs in a well-established animal model of inflammation. These proof-of-principle animal studies have demonstrated that encochleated NSAIDS enabled a statistically significant reduction in gastro-intestinal toxicity compared to standard formulations at clinically-relevant high doses of these NSAIDs and aspirin while providing comparable anti-inflammatory effects. (Related article: Vioxx alternative Celebrex increases risk of heart attack)

The Bioral technology uses soy-derived phospholipid and calcium to envelope (or “cochleate”, derived from the Greek word for “shell”) the drug in such a way that it appears to allow absorption to occur without the NSAID coming into contact with the gastric mucosa, thus reducing the incidence of mucosal ulceration that is often associated with NSAID and aspirin use. The major alleged benefit of the selective COX-2 inhibitors over the NSAIDs has been reduced gastrointestinal damage. However, the new laboratory findings show that it may be possible for this benefit to now be matched by applying the Bioral technology to NSAIDs and aspirin. In addition, these proof-of-principle findings show that nanoencochleated NSAIDs may reduce the common and expensive use of NSAIDs with H2 antagonists and proton pump inhibitors to protect the gastrointestinal lining of patients taking NSAIDs.

Recommended articles:

FDA should have never approved Vioxx

Celebrex should be recalled

FDA should not have approved Vioxx

That is what Dr. David Graham, Associate Director at the FDA's Office of Drug Safety, says in an interview with Fortune's John Simons. (Related articles: Vioxx approval may have been a mistake and Vioxx approval process was faulty). For those of you who may not know much about Dr. Graham, he was recognized by Forbes magazine as the Annual Face of the year, and he has criticized the agency since Vioxx was recalled. His name became even more famous because the FDA, which has sided with Merck in the Vioxx recall case, tried to destroy his career for criticizing the shoddy work of the agency.

Here are other comments from his interview with John Simons:

1. FDA's pushback on Vioxx was more intense than with other drugs. (Related article: How FDA started to work with drug industry instead of working for American people)
2. It is the FDA that is basically responsible for 100,000 people having heart attacks and as many as 55,000 people dying of those heart attacks. (Related article: Vioxx death toll revised upwards)
3. The FDA really let the public down. (Related article: How the FDA was hijacked by the drug industry?)
4. The people who approve a drug cannot be relied upon to regulate it. (Related article: Vioxx recall exposes the mess at the FDA)

Dr. Graham, a veteran at the FDA and respected worldwide for his credentials (Johns Hopkins, Yale, etc.) is now fighting for his job. It is no secret that the FDA and the current administration is full of pharmaceutical industry insiders along with over 600 lobbyists. Dr. Graham admits that he may lose his job soon. "The sense I get from management is that I am an enemy, a traitor, a pariah." What a treatment by a government agency for a person who is fighting on behalf of American people.

Dr. Eric Topol, world famous cardiologist and another critic of Vioxx, agrees with Dr. Graham's position. He has always held the position that Vioxx (and other drugs like Celebrex and Bextra) provide no benefits at all and were aggressively marketed directly to consumers by Merck and Pfizer. He writes in the Journal of American Medical Association, "With the considerably higher cost, marginal efficacy, and known cardiovascular risks of the remaining agents on the market, valdecoxib (Bextra) and celecoxib (Celebrex), it would seem prudent, at the least, to avoid using these agents as first-line therapy." (Related article: Celebrex should be recalled)

Dr. Topol, like Dr. Graham, believes that direct-to-consumer marketing of a drug that had too many side effects and hardly any benefits was responsible for the current crisis, "These drugs were mass-marketed from the moment they were commercially available in the new world of direct-to-consumer advertising, with unrealistic expectations about pain relief, marked gastrointestinal protection, and safety. Rather than a sufficient waiting period after approval to firmly establish safety in the large, representative "real world" population, the unbridled promotion exacerbated the public health problem." (Related article: FDA warns Pfizer on misleading ads)

Recommended article: History of Vioxx and its recall by Merck

FDA warns Pfizer on misleading Celebrex, Bextra ads

Since the recall of Vioxx on September 30, 2004 by Merck, Pfizer, the maker of other two Cox-2 drugs, Celebrex and Bextra, aggressively marketed the two drugs as alternatives to Vioxx. The big direct-to-consumer advertising campaign continued till several studies showed that both Celebrex and Bextra are not as safe as they have been made out to be. (Related article: Vioxx too was aggressively marketed to consumers by Merck)

FDA directed that the label for Bextra be changed to clearly show its adverse side effects. FDA and Pfizer also agreed that Pfizer will stop all direct-to-consumer advertising for Celebrex till its safety profile was better understood and the FDA could evaluate the safety of Cox-2 class and decide if a recall of Celebrex and/or Bextra was necessary. (Related article: Celebrex, like Vioxx, may be recalled)

Pfizer has maintained all along that Celebrex was still a safe drug and has conveyed this message in various statements, press releases, and television interviews. Most doctors, however, do not agree with Pfizer's assertions. The majority of physicians are suggesting that prescription of Cox-2 drugs like Celebrex and Bextra be limited to very special situations since none of these drugs are in any way better than over-the-counter painkillers and have serious adverse side effects. Vioxx is estimated to have killed/injured as many as 139,000 Americans and an unknown number outside the US.

The FDA has now sent a letter to Pfizer warning it about its misleading advertisements related to both Celebrex and Bextra. It is well known that Pfizer has received similar warnings for its other products for making claims that were either not true or were not substantiated by evidence. In a very strongly-worded letter, the FDA talks about five different ad pieces that it has found to be totally unacceptable. The FDA has directed that, "Pfizer immediately cease the dissemination of promotional materials for Celebrex and Bextra that contain claims and presentations the same as or similar to those described (in the letter)....The seriousness of the violations concerning your promotion of Celebrex described above would generally have warranted a Warning Letter; however, in light of your recent agreement to a voluntary suspension on all consumer promotion for Celebrex, we do not feel that is appropriate at this time. You should be aware, however, of the serious nature of the violations described above and act to avoid disseminating similarly misleading promotion for your products in the future." (Related article: Celebrex lawsuits follow the Vioxx class action lawsuits)

For the benefit of our readers, below are portions of the letter from the FDA to Pfizer.

**************

These five promotional pieces variously: omit material facts, including the indication and risk information; fail to make adequate provision for the dissemination of the FDA-approved product labeling; and make misleading safety, unsubstantiated superiority, and unsubstantiated effectiveness claims. They are, therefore, in violation of the Federal Food, Drug, and Cosmetic Act (Act) and FDA implementing regulations.

The omission or minimization of risk information in these promotional materials is a public health concern because Celebrex and Bextra are contraindicated for several patient populations, both products contain warnings of serious gastrointestinal (GI) effects and anaphylactoid reactions and Bextra contains an additional warning regarding serious, possibly life-threatening skin reactions. Celebrex and Bextra are associated with a number of serious risks, as stated in their respective PIs. (Related article: Treatment options for Vioxx, Celebrex, and Bextra patients)

The Guitar TV ad

Omission of (critical) information implies that there are no risks to the patient who takes Celebrex, which overstates the drug’s safety. (It) fails to offer options for persons who are uncomfortable with directly requesting additional prescription drug product information from their healthcare providers, persons without access to computers and the Internet, persons who are uncomfortable with actively requesting additional product information about a specific prescription drug by telephone, and persons concerned about providing phone numbers or other personal information in connection with their requests. (Related article: Americans scared after Vioxx recall)

The Arthritis Tips TV ad

(It) is a product-specific drug ad for Celebrex that is misleading because it omits important information about the drug’s safety and effectiveness and makes unsubstantiated effectiveness claims. The ad promotes Celebrex by identifying the drug by name at the beginning and end of the ad. Moreover, stating that Celebrex is presenting/bringing you arthritis tips clearly suggests that Celebrex is an arthritis treatment. (The) ad is misleading because it overstates the proven effectiveness of Celebrex for the treatment of “arthritis.” Celebrex is indicated only for relief of the signs and symptoms of OA and RA. Celebrex is not indicated for disease modification (i.e., altering the course of the progression of arthritis). Moreover, we are not aware of substantial evidence or substantial clinical experience demonstrating that treatment with Celebrex will prevent crippling effects or disability due to arthritis or prevent nursing home institutionalization of elderly patients with arthritis. Therefore, your Arthritis Tips TV ad greatly overstates the proven benefits of Celebrex. (Related article: Drug recall scams and deceptive advertising grows)

The print ad

(It) features the prominent headline “Strength They Can Stay With” and shows a chart comparing Celebrex, Ibuprofen and Naproxen, titled “6-Month Patient Persistency Rate.” Over the chart is the statement, “In a study of approximately 1 million patients, persistency rates of different OA/RA treatments were assessed at 6 months.” The tagline below the Celebrex logo in the print ad is “Proven strength that lasts.” The above referenced claims imply that Celebrex is more effective (i.e., stronger) than ibuprofen and naproxen for treatment of osteoarthritis or rheumatoid arthritis and that patients “stay with” or aremore compliant with Celebrex therapy than the compared products. We are not aware of substantial evidence or substantial clinical experience to support these claims. Therefore, the analyses do not constitute substantial evidence or substantial clinical experience demonstrating that OA/RA patients are more compliant with Celebrex or stay on Celebrex longer because it is more effective than other products for the treatment of OA or RA.

Bextra Direct Mail Brochure

The patient brochure, “How to Hit Arthritis Joint Pain Hard,” features safety claims and presentations that are misleading because they minimize the serious GI risks associated with Bextra therapy.

The totality of the graphic and the “stomach stays protected” safety claim are misleading because they suggest that Bextra provides significant protection from serious GI side effects. However, these safety claims are inconsistent with the Warning in the Bextra PI regarding serious and life-threatening GI side effects, including bleeding in the stomach and intestines. (Related article: Vioxx recall shows how FDA became toothless)

TV Infomercial

The 27-minute TV infomercial “On the Road to Joint Pain Relief” ad from Pfizer on arthritis and joint pain relief is a drug ad for Celebrex and Bextra that is misleading because it overstates its proven effectiveness and omits important information about the drugs’ safety and effectiveness. The infomercial points to and describes benefits from taking a specific prescription drug therapy from Pfizer, though it does not mention Celebrex or Bextra by name.

The infomercial also suggests that this drug is a breakthrough treatment (and the “right” treatment) offering superior effectiveness and safety over other arthritis treatments. The infomercial omits any risk information for Celebrex or Bextra. Therefore, the infomercial overstates the effectiveness of the drugs while minimizing, by complete omission, the risks. The infomercial features statements from healthcare providers and patient testimonials, two highly credible sources of information for consumers that greatly overstate the demonstrated benefits of Celebrex and Bextra. (Related article: Alternatives to Vioxx and Celebrex for pain relief)

We are not aware of substantial evidence or substantial clinical experience with Celebrex or Bextra demonstrating such effectiveness in these outcomes measures. We are not aware of any evidence showing that Celebrex or Bextra has superior effectiveness to nonselective NSAIDs. Indeed, none of the comparative studies with naproxen, ibuprofen, and diclofenac to-date has been designed to demonstrate superiority or a specified degree of similarity in a rigorous way. We are also not aware of any adequate and well-controlled studies evaluating whether Celebrex or Bextra is effective in patients who have previously failed non-selective NSAID therapies.

Furthermore, the infomercial portrays OTC therapies as posing safety risks, while there is no discussion of any risks for the treatment being promoted.The infomercial also fails to present a brief summary of necessary information related to side effects and contraindications or make adequate provision for the dissemination of approved product labeling in connection with the broadcast ad.

Recommended article: Vioxx alternatives Celebrex and Bextra increase the risk of heart attacks and have other side adverse side effects

Topical cream for Vioxx, Celebrex, and Bextra users

Since the recall of Vioxx and continued doubts about other Cox-2 drugs like Celebrex and Bextra (both of which may be recalled or required to have strong safety warning), other manufacturers of pain relief drugs for arthritis patients have started to talk now about their drugs. Their voices were drowned in the past due to the tens of millions of dollars spent on direct-to-consumer advertising by Merck and Pfizer. (Related article: Vioxx and Celebrex advertising to blame for deaths and injuries)

One such drug is called Pennsaid and it is a lotion, rather than an oral medication, used to treat pain and stiffness related to osteoarthritis. It combines diclofenac sodium, a widely used non-steroidal anti-inflammatory drug (NSAID), with a patented carrier. When spread on the skin, the lotion delivers direct pain relief while avoiding the inherent side effects of oral medications. Approved for use in Canada since 2003, Pennsaid is also available in the United Kingdom, Italy and the Caribbean. Pennsaid was invented in Canada and is not available in the United States yet. (Related article: Pain relief medication guide for Vioxx, Bextra, Aleve, and Celebrex patients)

The topically applied Pennsaid lotion has been proven to offer effective relief of pain and stiffness of osteoarthritis of the knee while offering a better overall safety profile than comparable oral medications. Three phase three clinical trials published in the Journal of Rheumatology, the Canadian Medical Association Journal and the Archives of Internal Medicine in recent months continue to drive awareness in the medical community of this medication which offers hope to those looking for a safe alternative to NSAID and COX-2 therapies.

The randomized, controlled 12-week trial in 622 patients with primary knee osteoarthritis published in the Journal of Rheumatology showed that Pennsaid was as effective as the maximum daily dose of comparable oral medication at relieving pain and stiffness, as well as improving the patients' assessment of overall well-being. The study also showed that applying Pennsaid led to fewer gastrointestinal-, renal- and liver-related side effects than oral medications.

The randomized, controlled, 4-week trial in 248 patients with primary knee osteoarthritis, published in the Canadian Medical Association Journal showed a 42 per cent reduction in pain, along with a 40 per cent improvement in stiffness and 30 per cent improvement in physical function following Pennsaid treatment.

The randomized, controlled 12-week study, which enrolled 326 patients with knee osteoarthritis published in the Archives of Internal Medicine, found that Pennsaid improved pain scores by 45.7 percent, physical function by 36.7 percent, and stiffness by 35.1 percent - a statistically significant difference over results from a control group that received the chemical carrier alone, minus the active drug. Two hundred and twenty-eight patients completed the study, and researchers measured the results using the same FDA-mandated standards applied to oral nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 selective inhibitors.

Pennsaid efficacy is important to note since it is topically applied. The main problem with Cox-2 inhibitors like Vioxx, Celebrex, and Bextra is that these have to be taken orally and that is why they cause enormous harm to the body. Vioxx was recalled by Merck after it was proven that as many as 139,000 Americans are either dead or seriously injured. Celebrex and Bextra, both taken orally, also have adverse side effects and are currently under evaluation.

Recommended article: Celebrex, like Vioxx, should be recalled in the interest of safety

History of Vioxx and its recall by Merck

Several readers have written to ask us about the history of Vioxx and how it was marketed by Merck. So we put our team to dig into the annual reports from 1999 to 2003 and here are our findings.

The title on the cover page of Merck's 1999 annual report (the only year in which Vioxx was featured on the cover of its annual report) declares, "Vioxx: Our biggest, fastest and best launch ever." Inside the report, Merck CEO Raymond Gilmartin boasts, "Vioxx is the fastest growing prescription arthritis medicine in the United States, and, by the end of 1999, Merck had successfully launched Vioxx in nearly 50 nations." A picture shows Elsy Jucker-Bianchi, 79, of Ossingen, Switzerland climbing the steps with her great-grandchildren. Wonder what happened to Ms. Jucker-Bianchi! (Related article: Americans scared after Vioxx recall)

Merck continues to talk about how aggressively it moved to market Vioxx to Americans, "Merck launched Vioxx in the United States last May, more than a month ahead of schedule, thanks largely to efforts by our Regulatory Affairs team in rapidly compiling the 500,000-page application for the U.S. Food and Drug Administration (FDA). Within days of approval, professional sales representatives including members of a specialty sales force fanned out to educate doctors about Vioxx and to provide them with samples." (Related article: Vioxx recall leads to doubts about overall drug safety in the US)

Vioxx was equally aggressively marketed to non-Americans. Merck boasts again, "It was the first drug in its class to be launched in the United Kingdom. Vioxx quickly became the most successful launch in the U.K. pharmaceutical industry...In Switzerland, it soared by its already-launched competitor to achieve market leadership in its class within just 17 weeks. Similar results have been achieved in Sweden, Germany, Puerto Rico and Brazil." (Related article: Vioxx recall makes drug regulatory agencies worldwide more careful)

In 2000, Merck continued its aggressive push for Vioxx and the CEO boasted, "(Vioxx) is already our second largest selling medicine overall. Vioxx is well positioned globally for long-term market leadership." The annual report further talks about Vioxx. "Global sales are running at an annual rate of more than $2 billion...Our drug already accounts for about half of all new COX-2 prescriptions written in the United States..." At that time the VIGOR study was already completed and Merck admitted that the data did not show that Vioxx was as safe as they had been claiming all along, "Although the VIGOR study was a GI outcomes study and was not designed to show differences in cardiovascular effects, significantly fewer heart attacks were observed in patients taking (Aleve) naproxen (0.1 percent) compared to the group taking Vioxx 50mg (0.5 percent) in this study. There was no difference in cardiovascular mortality between the group treated with Vioxx or naproxen." The Food and Drug Administration Arthritis Advisory Committee recommended in February 2001 that the study's results, as well as data on certain cardiovascular events, should be included in the labeling. "The FDA is not obligated to follow the advice of the Advisory Committee," Merck annual report commented.

But 2001 was not a great year for Vioxx and other drugs in the Cox-2 class. Gilmartin wrote, "...the COX-2 class (including Vioxx) experienced lower than expected penetration into the arthritis and analgesics market. This resulted in lower than expected growth for Vioxx, even while it claimed half of new prescriptions in its class. While we remain confident in the continuing worldwide growth potential of Vioxx (prescription trends for the COX-2 class have been recovering over the past several months), the product's 2001 sales did not meet our expectations."

In the 2001 annual report though, Merck talked a little more about the adverse side effects of Vioxx, but still tried to play with words to mislead the reader into believing that Vioxx was a safer drug than over-the-counter painkillers. "Explanations that have been proposed include that Vioxx increased the heart attack rate or naproxen decreased the heart attack rate. Although the underlying reason for the difference has not been established in prospectively designed clinical studies, Merck scientists believe the weight of evidence supports the theory that naproxen decreased the heart attack rate," Merck wrote explaining the results of the VIGOR study. While knowing all this, Merck hired Dorothy Hamill to launch a new direct-to-consumer (DTC) advertising campaign for Vioxx. The company said, "Merck believes DTC advertising is important because it encourages patients to talk to their physicians about their condition and possible treatment options. In 2001, Vioxx achieved $2.6 billion in sales, an increase of 18 percent over 2000." (Related article: Vioxx most dangerous drug in Cox-2 category)

In 2002, Vioxx was no longer a new drug and the company merely mentioned it in its annual report. The same tone is seen in 2003 as Merck continued to experience slower growth and its profitability declined. It will be interesting to see what Merck writes about Vioxx in its 2004 annual report. Vioxx was recalled on September 30, 2004.

Recommended article: Why Merck did not recall Vioxx earlier?

Merck's aggressive approach to Vioxx lawsuits

Based on the emails that we have received from Vioxx victims and shareholders of Merck, it is easy to conclude that Merck has taken a very arrogant approach towards people who took Vioxx, Merck shareholders, and other pharma industry watchers. This has confounded everyone and there are several theories why Merck has shown no remorse for hurting as many as 139,000 Americans and even more people outside the United States. (Related article: Vioxx death estimate revised upward)

For instance, since Merck recalled Vioxx, the company has been flooded with both individual and class action lawsuits. Most analysts agree that Merck's liabilities will be around $18 billion. But Sanford Bernstein analysts estimate Vioxx liabilities to be $38 billion and other estimates put the liabilities to be as high as $55 billion. Like any other company would have done, Merck should have highlighted this liability in its financial statements and should have made a provision for it. On the contrary, Merck has made no provisions whatsoever for its Vioxx liabilities. (Related article: Merck's financials hurt by Vioxx recall controversy)

Since the recall of Vioxx, the company has mounted an aggressive attack on Vioxx victims and attorneys who are helping then seek compensation for their suffering. The company has refused to apologize for family members of those killed by Vioxx and those Americans who consumed Vioxx after the company aggressively marketed the drug claiming that it was a drug safe for human use, had fewer side effects and would make life of arthritis patients easy. (Related article: Merck heavily marketed Vioxx through direct to consumer advertising)

Now the same company is ready to fight it out with Vioxx victims in courtrooms across the country. Anita Larsen, a spokeswoman with Merck, conveyed the company's arrogant attitude by saying that the company is confident and intends to defend itself over a "number of years" in each of the cases filed across the country. "There's really a considerable burden to demonstrate that Vioxx as opposed to other factors caused the heart attack," she said, essentially abandoning its customers who made Vioxx a blockbuster drug and resulted in huge bonuses and raises for its CEO Raymond Gilmartin and other executives and a spectacular rise in its stock price. (Related article: Preparations begin on both sides for tough Vioxx trials)

This has made analysts and Vioxx lawyers wonder if there is something that Merck knows that no one else knows. There is overwhelming evidence against Merck that the company may have known as early as 1996 that Vioxx was a dangerous drug. There are reports based on internal memos and documents that company trained its sales representatives to duck tough questions about the drug's effects on the heart. A document called "Dodge Ball Vioxx" where each of the last four pages of potential questions that might be posed by physicians was emblazoned with "DODGE!" was used to prep Merck employees to avoid the topic of safety of Vioxx. (Related article: Merck leaves no options for Vioxx victims than to file lawsuits)

One theory that has been gaining credibility in recent weeks is based on the fact that since the recall of Vioxx, heat has been raised in Washington on the issue of banning class action lawsuits that will effectively eliminate the prospects of Vioxx victims to seek compensation for their pain and suffering. Both Merck and Pfizer (maker of Vioxx alternatives Celebrex and Bextra - both of which are being evaluated by the FDA) have embarked on a PR campaign designed to make it hard for Vioxx class action lawsuits to go too far. (Related article: Americans about to lose their right to sue drugmakers)

And it is obvious that the strategy is working. Merck has many friends in Washington starting all the way from The White House and Senator Orrin Hatch to Congressmen who owe their election to contributions from Merck and other lobby groups working for the pharmaceutical industry. It is no coincidence that PhRMA, the association of pharmaceutical industry, has hired Billy Tauzin, a retired Republican Congressman, to head its efforts to change the laws in the United States and deny the Americans the right to sue drugmakers. Senator Orrin G. Hatch, speaking on behalf of Merck said, "For example, it has been alleged that Merck trained its sales representatives to 'dodge' tough questions from doctors about Vioxx. I have reviewed the Merck training anual and I can tell members of the Committee this is not the case." Or in other words, he does not think Merck did anything wrong by knowingly marketing a killer drug. In fact, he continued by saying that the Senate was wasting its time discussing Vioxx recall case. "I do have concerns about why this Committee is holding this hearing, and holding it now....some are trying to punish one drug company for acting appropriately within the framework of our current regulatory system."

Recommended article: Vioxx victims come under attack from all sides for exercising their legal right to sue

Vioxx victims come under attack for filing lawsuits

United States is fast becoming the only country in the world where the government is actually actively working to take away the rights of Vioxx victims and protecting Merck (Related article: FDA sides with Merck in Vioxx recall case), the manufacturer of the drug. According to government's own estimates, which typically tend to undercount deaths, the current Vioxx death toll stands at a staggering 139,000 Americans.

While governments in other countries are working overtime to figure out what to do with Cox-2 drugs and help the victims of Vioxx, the US President declares that, "...What's happening all across this country is that lawyers are filing baseless suits...That means you're paying for junk lawsuits every time you go to see your doctor..." Bush also presented many other statistics at a speech yesterday that most analysts do not agree with. In fact his own Deputy Assistant for Domestic Policy says, "The Congressional Budget Office estimated that malpractice costs account for about 2 percent of health care spending, equaling about $28 billion per year." By contrast, pharmaceutical costs are estimated at between 12% and 16% of health care costs. "If President Bush wants to create more affordable and accessible health care, he should allow Americans to buy their prescription drugs through bulk purchasing programs as Canadians do and he will reduce health care costs by up to 10%," said Jamie Court, president of the Foundation for Taxpayer and Consumer Rights. "The President should not be scaring the public into falsely believing they must give up their right to go court out of fear of losing their ability to go to an emergency room." (Related article: Americans scared after Vioxx recall)

Yesterday's invitation-only meeting in Illinois was attended primarily by doctors (How many doctors wear lab coats outside of labs, and interestingly enough, at social events in auditoriums?) and small business owners. The President did not meet with any victims who have been hurt by Vioxx. Twenty-nine survivors of medical malpractice in Illinois sent a letter to him saying, "It is unacceptable for you to meet with doctors, or with representatives from hospitals, drug companies, HMOs, and the insurance industry - indeed with all the corporate interests who would benefit from your cruel medical malpractice legislation - while failing to meet with the very people who will be hurt most." They further pleaded, "We cannot compete with these kinds of financial contributions from special interest lobby groups. But we are citizens who have lost a tremendous amount and you need to listen to our stories as well." (Related article: Vioxx manufacturer made campaign contributions to recently elected politicians)

Several analysts agree that the class action lawsuits are not the culprit but with Vioxx class action lawsuits exploding and other lawsuits being filed in case of injury by Celebrex and Bextra, the pressure from companies like Pfizer and Merck on lawmakers has increased, particularly after millions of dollars were paid in campaign contributions in the recent election. Jay Angoff, director of the Missouri Department of Insurance from 1993 to 1998, said in a conference call that the problem actually lies with the insurance industry, another major contributor to recently elected Republicans, "The president is doing the wrong thing at the wrong time in the wrong place. Insurance companies have never made more money than they did in 2004. The insurers are rolling in dough; they're swimming in dough," Mr. Angoff said. (Related article: Americans want to retaliate against Merck after Vioxx recall mess)

Data released last month by Weiss Ratings reveal that insurance industry profits were up 54% in the first six months of 2004. The data follow a trend of increasing insurance industry profitability, even as malpractice insurers claim rising costs are forcing them to raise doctors' premiums.

U.S. businesses file lawsuits four times more often than individuals, according to an analysis of states and counties that keep such data by a non-partisan group, Public Citizen. Moreover, businesses are 69 percent more likely to be sanctioned by federal judges for filing frivolous lawsuits than are tort plaintiffs and their attorneys, according to an analysis of the 100 most recent cases where such sanctions were imposed. (Related article: Preparations begins for tough Vioxx litigation)

The frequently cited study that contends lawsuits cost taxpayers well over $200 billion per year (the so-called 'tort tax') has been repudiated by the nonpartisan Congressional Budget Office (CBO). According to CBO, the costs estimated by Tillinghast-Towers Perrin 'merely shift money from injured to victims and thus are not true costs to society.' These 'costs' are actually the total cost of the liability insurance industry, and they would not disappear even if the legal system did not exist. Overall, 46 percent of the tort cost estimate is for payments made to injured victims for lost wages, medical care, and pain and suffering. These costs are the result of injuries caused by defendants and would be borne by society anyway, through private health insurance, government programs and charities, or by being absorbed by victims and their families. And 21 percent of the tort cost estimate is for insurance industry overhead. (Related article: Vioxx victims in Michigan and Texas cannot file lawsuits against Merck and Pfizer)

Tort lawsuit filings have decreased 9 percent overall from 1992 through 2001, according to a joint tracking project of the Conference of State Court Administrators, the Bureau of Justice Statistics and National Center for State Courts. The filing data from 30 states represent a total of 74 percent of the U.S. population. When adjusted for population growth, tort filings declined by 15 percent, from 269 to 228 per 100,000 over that period.

"President Bush doesn't let facts get in the way when it comes to his political goal of dismantling the legal system," said Joan Claybrook, president of Public Citizen. "He prefers to coddle campaign contributors, rather than protect consumers and patients," added Frank Clemente, director of Public Citizen's Congress Watch. "This is not a debate among reasonable people. It is a massive campaign of distortions carried out by the administration in league with its business allies. The fact is, the emperor has no clothes." (Related article: Merck continues its ferocious attack on Vioxx victims)

In the meantime a memo prepared for Republican lawmakers entitled 'The Language of Lawsuit Abuse Reform' has been leaked and it argues that those seeking to limit medical liability need to fan the public's fear about the threat to closure of medical facilities ("Nothing scares a person more than needing emergency medical care and not being able to get it") and to use 'crisis' words that invoke fear of lost services ("crippling our health care system...lawsuit epidemic...The price of saving lives is just too high...too many doctors are leaving and too many hospitals are closing"). (Related article: Attorneys soothe nerves of Vioxx victims)

But many analysts agree that it is the poorest Americans that get hurt the most when their rights are taken away. "If you cannot find an attorney, you will not have your day in court, and the caps on jury awarded damages advocated by President Bush will prevent individuals with legitimate cases on behalf of low wage earners, seniors and children from finding attorneys," said Jamie Court, president of the Foundation for Taxpayer and Consumer Rights, who has worked with hundreds of medical malpractice victims in California. "President Bush should not represent a cap as fair and just when it blocks access to justice for the most vulnerable patients. He should be discussing how to regulate insurance company profiteering and behavior, not allowing those who cause human suffering to escape legal accountability."

Recommended article: Vioxx drug liability - a new mass tort

Michigan and Texas Vioxx victims can not sue Merck

There are tens of thousands of Vioxx victims and hundreds of Vioxx attorneys willing to help them with lawsuits against Merck. The irony is that while foreigners can do so, even in the US courts, all Americans themselves cannot do so. The reason: States like Michigan and Texas have passed laws that protect drug companies even if they make drugs that kill.

For instance, in Michigan, if the drug was approved by the Food and Drug Administration, then there is basically no case against the drugmaker. Plaintiffs can win damages only if they prove a company withheld or misrepresented information about a drug that would cause the FDA to not give or withdraw its approval. In Texas, drug makers are also protected from any liability as long as they can prove that any warnings of harmful side effects were provided to the FDA.

Now, this means that if the FDA was on the side of American people, they would have some hope. But since the day Vioxx was recalled, FDA has essentially tried to protect Merck, and through its inaction on Celebrex recall, Pfizer.

And that is not the end of the troubles facing American victims of Vioxx. President Bush is actively working on legislation that will essentially bring the laws in Michigan and Texas to all states by preventing American people from seeking punitive damages from the makers of Vioxx and Celebrex. While Vioxx attorneys have tried to soothe the nerves of Americans scared after a volley of attacks from Merck and the administration, lawmakers may go ahead with the legislation that will take away the right of American people to sue a drug company even if loved ones are dead or they are themselves permanently disabled or seriously injured. Voicing the concerns of Americans, Todd A. Smith, President, Association of Trial Lawyers of America, says, "The President pretends that taking away the legal rights of American families will reduce health care costs, while knowing that the non-partisan Congressional Budget Office has reported that even if all the costs of medical malpractice—all the payouts, all the insurance costs, all the medical expenses—were eliminated, the savings would be no more than one-half of one percent." He adds that protecting companies at the cost of American lives is not good public policy, "While perpetuating myths, President Bush unashamedly advocates legislation that would protect insurance industry profits and prohibit any punishment for the makers of dangerous drugs like Vioxx, while penalizing your mother for being abused in a nursing home or your daughter for having her baby killed by medical malpractice." He concludes by saying that the only people President Bush wants to help are the big insurance, tobacco, drug and chemical industries, and at the expense and safety of the American people. (Related article: Tough Vioxx litigation expected)

In the meantime, in a series of excellent investigative reporting by Melissa Davis of TheStreet, more facts are coming out about how Merck may have used Vioxx to push its sales and profits higher. And Merck leadership benefited from it. The company CEO, Raymond Gilmartin, now known for his callous attitude towards Americans and nationals of other countries killed by Vioxx, got a raise of $100,000 to $1.3 million and his bonus was increased to $1.7 million. How did Merck achieve remarkable financial performance? Through Vioxx, of course, which was aggressively marketed to unsuspecting people worldwide that it was the safest drug. Edward Scolnick, Merck's research director at the time, in an interview with the Wall Street Journal, admitted that Vioxx was the company's savior. (Related article: Merck's attack on Vioxx victims increases its stock price)

At the same time, scientists were questioning the safety of Vioxx and other Cox-2 drugs. But Merck did not want anyone to question it or its research. In fact, as Melissa Davis reports, Gurkipal Singh, an adjunct professor of medicine at Stanford University, believes that Vioxx looked risky even before regulators approved it for public use. But when he approached Merck to conduct additional research, Merck threatened him. "I persisted in my inquiries and I was warned that if I continued in this fashion, there would be serious consequences for me," Singh said to Melissa Davis. "Subsequently, I learned that this was a persistent pattern of intimidation." Similar behavior was meted out to Dr. Eric Topol. In fact, Merck hired pseudo-consultants whose job was to defend Vioxx at medical conferences and in medical journals.

All this time, however, it is inconceivable to many Americans that FDA knew nothing about the problems with Vioxx. But the industry lobbyists working overtime and an administration extremely friendly to the drug industry, nothing was done as tens of thousands of Americans continued to die (Related article: Vioxx recall and Washington politicians). In fact, while Vioxx was killing people, Raymond Gilmartin along with other employees at Merck, and other drug companies were contributing millions of dollars to election campaigns of mostly Republicans.

Recommended article: Vioxx recall exposes the mess at the FDA

Vioxx death estimate revised upwards

It appears that the number of deaths caused by Vioxx will be revised upwards to between 89,000 to 139,000 (the data is for the United States alone). Andrew Jack of the Financial Times who interviewed Dr. David Graham, an expert at the FDA, is reporting that the data is likely to be published in the medical journal The Lancet.

In the initial estimates provided by the FDA, 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003 were attributed to Vioxx. Dr. Graham has provided these estimates in subsequent statements and since then most analysts have put worldwide deaths to be somewhere in the range of 150,000 to 200,000.

It may be pointed out that since his testimony before Congress, Dr. David Graham is fighting to keep his job. The FDA, which has literally been hijacked by the drug industry, does not want any data to be released that exposes the mess at the agency. Dr. Graham has been able to keep his job so far after lawmakers intervened and he sought protection as a whistleblower, but it seems that he really has no support within the agency or in the Bush administration. Several spokespersons in the administration, instead of admitting grave errors at the FDA, have said that the agency was actually doing a "spectacular job" of protecting the public. In his interview with FT, Dr. Graham is quoted as saying that he suspects that he might lose his job for publishing these findings. (Related article: Vioxx recall exposes the mess at the FDA)

The FDA has methodically tried to discredit his work and the nasty fight between the agency and Dr. Graham is now public news. Details of disagreements between Dr. Graham and the official position of FDA are actually available on FDA's website. Dr. Graham now claims that while his superiors at the agency have not granted him permission to publish his work but no one has yet disputed the data provided by him. Merck, for obvious reasons, does not agree with the data either. (Related article: Merck defends its Vioxx strategy)

These higher numbers of Vioxx related deaths and injuries are also likely to bolster the case being made by scientists and doctors who have been asking for recall of Celbrex and Bextra as well since both these drugs belong to the same Cox-2 inhibitors category. FDA is scheduled to review the whole class of Cox-2 drugs at its advisory committee meeting in February 2005.

The publication of the revised data is also going to help Vioxx victims and Vioxx attorneys who are currently getting ready for their class action lawsuits. This research will strengthen their argument that Vioxx killed people over a period of several years and Merck could have stopped those deaths but chose not to. (Related article: Celebrex safety concerns good news for Vioxx victims)

The number of deaths that can be attributed to Vioxx has always been a difficult number to estimate. While estimates are still relatively easy to generate for the United States and other countries in the developed world, it is almost impossible to estimate deaths caused by Vioxx in poor countries where literally no records are kept and government agencies typically do not track this data.

Recommended article: Merck's Vioxx liabilities could be $38 billion

Vioxx and Celebrex advertising to blame for injuries

When drugs are sold as consumer products, it is hard for consumers to appreciate the difference. No wonder than that at least half of all Americans takes at least one prescription drug, with one in six taking three or more medications. But what role did direct-to-consumer advertising play in Vioxx related deaths and injuries? And if direct-to-consumer advertising is such a wonderful thing, as claimed by PhRMA (Related article: Advertising strategy for prescription drugs), the association of drugmakers in the US, then why was all Celebrex advertising pulled off after it was found that Celebrex increased the risk of heart attacks and the drug was likely to be recalled? (Related article: Pfizer refuses to recall Celebrex despite safety concerns and mounting class action lawsuits)

Drug industry spokespersons admit that direct-to-consumer advertising may be a problem

Indeed, Dr. Eric Topol, the world-famous cardiologist and an early critic of the dangers of Vioxx, has been calling for putting an end to direct-to-consumer advertising, but many other experts think that direct-to-consumer advertising may have exacerbated the situation. In other words, more Americans may have been killed or injured because they believed the cheerful images and words in ads for Vioxx and Celebrex.

While Merck CEO Raymond Gilmartin (Related article: Courts force Gilmartin to testify in Vioxx class action lawsuits) has refused to come clean and apologize for Vioxx related deaths and injuries, his peer Hank McKinnell, CEO of Pfizer is speaking out against direct-to-consumer advertising. In an interview with Fortune magazine, McKinnell admits that drug ads fail to communicate the adverse side effects. It is no secret that the announcer's voice is softer and the reading pace much faster when talking about adverse side effects. The text on the television screen and in print media about side effects is smaller as well and is written in highly technical language making it almost impossible for an average consumer to fully understand the risks. McKinnell adds, "...We have left the impression that all drugs are safe. In fact, no drug is safe... I see a role for direct-to-consumer advertising, but there are unintended consequences that we're all going to have to deal with."

McKinnell deserves praise for admitting his mistakes. His own company Pfizer aggressively advertised Celebrex after recall of Vioxx. If problems would not have been found with Celebrex, Pfizer might have spent over $100 million on advertising Celebrex alone in 2004.

Dyke Hendrickson, an analyst who follows the drug/biotech industry, agrees with McKinnell. He says, "Life sciences executives should spend more money on educating the public and less on advertising..." He suggest that drug companies launch public-awareness campaigns to let consumers know what they are doing to ensure public safety. Management consultants agree that this is the right thing to do.

Tips for consumers when you watch an ad for a prescription drug

1. Do not forget that this is an ad. So don't believe everything.
2. While doctors do not like their patients telling them what drug to prescribe, it is still OK to talk to your doctor about a drug if you can't stop yourself. But always trust the opinion of the doctor rather than ask for a specific drug simply because a friend told you about it or you watched it on television.
3. Visit the website of the drug/company and do your research about it. More specifically do a Google search, and see if other respectable websites are talking about it.

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