Pfizer applies for approval of another Cox-2 inhibitor

Since the recall of Vioxx, all drugs in the Cox-2 inhibitor category have come under intense scrutiny because they all employ the same mechanism to alleviate pain (Related article: Vioxx recall focuses limelight on Cox-2 inhibitor drugs). Apart from Vioxx, which was recalled in September 2004, there are two other drugs still on the market: Celebrex and Bextra (both made by Pfizer). Bextra now carries a strong warning because of cardiovascular risks and serious skin reactions. Similarly, Celebrex has been found to increase the risk of heart attacks.

Another Cox-2 drug, Deramaxx (known generically as deracoxib), that is used as a painkiller for dogs (not approved for human consumption) but works like Vioxx, Celebrex, and Bextra has also come under scrutiny since it has caused deaths of many dogs. This has also focused limelight on another Cox-2 drug Prexige (lumiracoxib) that was meant to be sold as a competitive product to Vioxx but its manufacturer Novartis withdrew the application in Europe after Vioxx was recalled. The application for approval of Prexige has not yet been filed with the FDA. (Related article: Additional evidence found for problems with Prexige)

Now comes the news that, as announced by Pfizer in October 2004, Pfizer has filed an application with the FDA for approval of parecoxib, the injectable version of valdecoxib (Bextra), for treatment of acute pain. It is important to note that while parecoxib is a Cox-2 drug and is no different than Bextra, it is not a conventional painkiller for arthritis. On the other hand, parecoxib is administered intravenously or as a shot into a muscle after surgery.

But not all data about parecoxib is positive. According to the the European Medicines Agency (EMEA) and its Scientific Committee for human medicines, studies showed a higher rate of serious cardiovascular thromboembolic events (e.g. myocardial infarction, cerebrovascular accident) in the parecoxib sodium (Dynastat/Rayzon)/valdecoxib (Bextra) treatment arm compared to the group of patients receiving placebo. This was not observed in a general surgery setting. Accordingly, EMEA has issued warnings on parecoxib and has instructed both doctors and patients to consider the risks of using parecoxib before prescription.

FDA is scheduled to conduct a complete review of the Cox-2 drugs in early 2005 and similar reviews are going on in other parts of the world. There is disagreements among doctors whether all Cox-2 drugs should be recalled till their risk-benefit profiles are better understood, but the world-famous cardiologist Dr. Eric Topol, is not yet convinced that Cox-2 drugs do any more good than an over-the-counter painkiller in most cases.

Related article: FDA limits Celebrex and Bextra use due to Vioxx scare

Tips on case review by Vioxx attorney

Dozens of Vioxx victims have written asking about how to get their case reviewed by an attorney. This is the right approach since after Vioxx recall, there has been an explosion in fraud and scams. While you must get your case reviewed by an attorney, here are a few tips to keep in mind on how to pick the right attorney and how to handle the issue. If you have not read our article on how to find a Vioxx attorney, you may want to read that before reading these tips. (Note, while this article talks specifically about Vioxx recall, the information is equally applicable to recall of Celebrex and Bextra)

1. Do not submit your information to a website that you find in a search, particularly if the website does not provide any information about who is behind it, does not have complete information on names of Vioxx attorneys, and does not mention a physical location with a telephone number that you can use.
2. Generally speaking, a law firm that advertises its services (e.g. on this website) is safe to use since they are doing business with an American corporation (like Google, in this case) and Google has already screened them.
3. A website that has an .org in the end or has a ridiculous address that has nothing to do with information for consumers, e.g. sunsat-energy.org, pescxml.org, ohiotechnet.org, sosfemmes-endetresse.org, etc., you must be very careful. If a website exists for the sole purpose of collecting personal information of Vioxx victims, you must not use it. (Note: This website is part of a lifestyle website focused on providing latest information for consumers on a variety of issues. You can visit the website at http://www.mynippon.com)
4. If something appears too good to be true, it probably is not true. Use your judgment there. For instance if someone promises that you will get rich from Vioxx class action lawsuits, you are clearly being misled.
5. It does not make sense to contact an intermediary any way. Vioxx attorneys are directly soliciting cases and providing free reviews of cases. You will only be wasting your time by going through a website that is not run by a law firm that has filed a Vioxx class action lawsuit.
6. If you are still in doubt, call the law firm first before submitting your personal, confidential information.
7. If someone is offering you a cash advance for compensation from a settlement of Vioxx litigation, read our article on how to negotiate a Vioxx recall lawsuit cash advance.
8. It is perfectly fine to seek help from a friend or a relative (who may be somewhat experienced in legal matters), rather than trust a complete stranger. While we do not provide legal or medical advice, we do answer questions from our readers. You are welcome to ask us questions (as dozens of people do, and some of that is published in form of articles, like this one) by contacting us. Please note that we are not affiliated with a law firm or a drug company. We are a lifestyle website.
9. Finally, spend some time on Vioxx/Celebrex/Bextra recall resources on this website. Since the recall of Vioxx, we have complete coverage of the issues. Get familiar with what is going on, educate yourself (if you are educated about the issue you will be able to deal better with an attorney and get a better case review), and only then take the next step.

Recommended article: Vioxx recall lawsuits against Merck exploding

Tough Vioxx litigation expected

Apart from dealing with Merck's attorneys who have declared that they do not plan to have any out-of-court settlements with Vioxx victims, relatives of those who lost their lives after taking Vioxx or those who suffered injuries have another enemy that they have to face in the coming months: legal changes planned by President Bush.

Vioxx recall (and troubles with Celebrex and Bextra) have energized the lobbyists who want to take away the rights of American people to sue drugmakers when they make killer drugs. And as they say in Washington, all stars are now aligned in their favor. All branches of government are controlled by a party that is committed to changing class action lawsuits which Americans have found as an effective tool to fight large corporations with their unlimited power and deep pockets. (Related article: Americans may soon lose their right to sue companies like Merck)

Let us review the list of events that are going to act against Vioxx victims unless something is done to stop them:

1. The so-called Class Action Lawsuit Reform Act (being marketed using the buzzword "tort reform") has already passed the House and an effort will be made it to get it passed through Senate. President Bush has put all his weight behind it since he received million of dollars in campaign contributions from business groups that want to deprive Americans of their right to sue a pharmaceutical company when it causes death or injury through defective drugs.
2. The Pharmaceutical Research and Manufacturers of America (PhRMA), which spent as much as $8 million on lobbying in just six months of 2004 (the latest period for which data is available) has now hired Billy Tauzin (a retired Congressman who showed that he is no friend of American people when he was head of the House committee that regulates the pharmaceutical industry) as its chairman. Tauzin received more than $218,000 in campaign contributions from pharmaceutical manufacturers over the past 15 years, says the Center for Responsive Politics, a campaign-finance watchdog group. Tauzin has consistently opposed allowing import of prescription drugs from Canada and other similar wishes of American people. The biggest item on the agenda: let drug companies do whatever they want.
3. In the same period, the Chamber of Commerce of the U.S. and its Institute for Legal Reform spent $30 million on lobbying and advertisements emphasizing the need for tort reform.
4. The pharmaceutical companies separately spent $46 million on lobbying and this does not include campaign contributions made to politicians, most of whom won the elections. No surprise then that in a search conducted for 2004 election cycle, 276 records were found for Merck employees, including several mentions of CEO Raymond Gilmartin.
5. The American Medical Associations spent $9 million on lobbying in the six-month period and it also has tort reform on its agenda.

What does it mean for Vioxx victims?

It is not going to be easy for them to receive compensation from a company that has vowed to fight vigorously any demands from Vioxx victims. Now that it has the support of the administration and the FDA, Vioxx attorneys will have to work extremely hard to fight for victims.

Recommended article: Americans scared after Vioxx recall

Preparations begins for Vioxx legal battles

Vioxx victims do not have many friends right now. The battle lines are being drawn for Vioxx related class action lawsuits that are expected to go on trial in early 2005. As Merck CEO prepares for answering questions from plaintiffs' lawyers and Vioxx attorneys build their case for seeking compensations, Merck, along with the FDA and Bush Administration is on the attack. Almost everyone out there is trying to make Vioxx victims feel as if something is wrong with them to ask for compensation from Merck for deaths and injuries. Since the recall of Vioxx in September of this year, Merck has actually mounted an aggressive attack on Vioxx victims rather than apologizing for killing tens of thousands of people worldwide and injuring many others. (Related article: Merck continues its aggressive attack on Vioxx victims)

There is another battle being fought in the medical community and this too is part of Merck's attack campaign on Vioxx victims and critics. It is pretty obvious that Merck is getting ready to mount a strong defense in hundreds of Vioxx related class action lawsuits filed by victims.
Essentially the strategy that Merck and its sympathizers are adopting is to attack and discredit anyone who questions their position. You might recall Dr. David Graham, an expert at FDA, who criticized the FDA for its mishandling of Vioxx recall and pointed out that there were at least four more drugs that are as dangerous as Vioxx. Well, he almost lost his job. Only when the senators intervened and the media pointed out the injustice, did he survive. But it is very likely that he will be treated like a pariah and might leave the agency in disgust. (Related article: Vioxx recall critic Dr David Graham harassed by FDA)

Another important person to mention here is Dr. Eric Topol, the world-famous cardiologist. He was an early critic of Vioxx and had asked that the drug be recalled soon after it was approved. Over the next few years, Merck mounted an aggressive campaign in the medical journals to discredit his work. Merck scientists and paid consultants to Merck continued to write articles and letters in medical journals defending a killer drug rather than withdrawing it or issuing warnings to Vioxx consumers. (Related article: Vioxx approval may have been a mistake)

Now the battle with Dr. Topol has intensified. Merck, the FDA, and magazines friendly to Merck (e.g. Fortune magazine published a misleading article accusing Dr. Topol of baseless conflicts of interests.) are mounting a campaign to discredit Dr. Topol. In the latest issue of New England Journal of Medicine, Merck scientists Peter S. Kim, Ph.D. and Alise S. Reicin, M.D. along with FDA scientists Lourdes Villalba, M.D. and James Witter, M.D., Ph.D. have tried to defend their positions and attack Dr. Topol in very strong language saying that he "shows a lack of understanding of the FDA's regulatory authority" and "Dr. Topol's remarks....are false." Merck scientists conclude by saying, "The record, in short, is one of careful analysis at every stage, a continued commitment to research, and prompt and decisive action in response to clinical-study results." Sounds like a lot of marketing baloney that not many Vioxx victims are likely to buy.

In fact, Dr. Topol sets the record straight by pointing out that a critical study was never published and available solely through a subsequent FDA memorandum, and the data presented also suffered from errors of omission. In his opinion, "...many vital steps were not taken (by Merck) to evaluate the cardiovascular safety of rofecoxib (Vioxx) properly." He further adds that, "It took 14 months after the expert FDA panel convened, from February 2001 to April 2002, to change minimally the cardiovascular safety information for rofecoxib (Vioxx) in the package insert. After their cumulative meta-analysis, Juni et al. (scientists at Department of Social and Preventive Medicine, University of Berne, Berne, Switzerland) correctly stated, "Our findings indicate that rofecoxib (Vioxx) should have been withdrawn several years earlier."

Like Vioxx victims, many doctors in the country do not believe any of the arguments presented by either Merck or FDA. The New York Times is reporting that doctors at the Mayo Clinic, the federal Veterans Affairs Department and the Kaiser Permanente health plan have been sharply limiting their use of Vioxx and Celebrex for years. That is because those three institutions, after undertaking separate reviews of test data available on various painkillers, reached the same conclusion: For most patients, Vioxx, Celebrex and a related drug, Bextra, did not work any better than older pain relievers or provide any safety benefits beyond them. These drugs achieved blockbuster drugs simply because of slick direct-to-consumer advertising by Merck and Pfizer.

Recommended article: Merck leaves no other options than class action lawsuits by Vioxx victims

Merck CEO to be deposed in Vioxx class action lawsuits

Since the recall of Vioxx and subsequent statements by attorneys that they are filing class action lawsuits against Merck to seek compensation for deaths and damage to health of millions of people, the company has been conducting an organized attack campaign on Vioxx victims. (Related article: Merck continues its attack on Vioxx victims)

Not only has Merck refused to apologize for tens of thousands of deaths and injuries from Vioxx, it has also declared that it will not give any compensation at all, that it has no responsibility for deaths and injuries, and that it will argue in the courts that there is no basis for class action status in Vioxx lawsuits. (Related article: Merck vows to fight Vioxx class action lawsuits vigorously)

Merck has done so through a well-organized media strategy in form of press releases and statements by its senior executives and spokespersons. Merck chairman and chief executive officer Raymond Gilmartin has appeared frequently on television to reinforce the message that the company did nothing wrong, that it recalled Vioxx as soon as it knew that the drug was killing people worldwide, and that there is nothing else to do going forward. Almost all of these statements are not considered to be credible by doctors and industry watchers. The Wall Street Journal found that Merck knew as early as 2000 that Vioxx was killing and injuring people. (Related article: Merck's response on Vioxx recall)

Despite such an aggressive campaign to get the word out on its position, Merck CEO did not want to answer questions from the plaintiffs' attorneys in Vioxx class action lawsuits. The good news is that the courts in New Jersey have granted the request of plaintiffs and has directed Gilmartin to answer questions as to how much he knew about the dangers of Vioxx before his company abruptly pulled the pain killer from the market. Many analysts suspect that Merck employees actually developed and executed a well thought out strategy to hide critical facts about the dangers of Vioxx and continued to aggressively market the drug while many in the medical community questioned its safety.

There are reports that the company actually provided training to its sales staff on how to answer questions from doctors. In medical journals, several doctors have argued that many so-called experts who came to the defense of Vioxx were actually paid by Merck to write favorable articles. It will, therefore, be interesting to find out how much Gilmartin knew and why he did not act on the knowledge. (Related article: So why did Merck not recall Vioxx earlier?)

The AP is quoting Merck attorneys as saying Gilmartin will likely be deposed sometime in March. Hundreds of class action lawsuits have been filed worldwide against Merck in the Vioxx recall cases and it is very likely that only one deposition may be held in the United States.

Recommended article: How Merck is getting ready for Vioxx class action lawsuits?

Additional evidence of problems with Vioxx type drugs

As many of our readers know, Vioxx is a drug that belongs to a category of drugs called the Cox-2 inhibitors since these drugs target an enzyme in the stomach called Cox-2. Vioxx was recalled because it increased the risk of heart attacks (tens of thousands of Vioxx patients died from these heart attacks and others have suffered irreparable damage to their cardiovascular systems).

There are two other drugs on the market right now that belong to the Cox-2 category: Celebrex and Bextra (they are sometimes sold by other brand names outside the United States). When it was found that Bextra was causing many cardiovascular complications, FDA directed its maker, Pfizer, to add a warning to Bextra label. More research has shown that Celebrex also has adverse side effects but the data is not conclusive yet. Pfizer is insisting that while both Celebrex and Bextra are Cox-2 drugs their molecular structure is different from that of Vioxx, and hence, they are not as dangerous as Vioxx. This is their main line of argument against recalling Celebrex and Bextra though most medical experts think that in the interest of patient safety, both these drugs should be recalled. (Related article: FDA issues an advisory against Celebrex and Bextra)

The doctors, patients, and drug agencies all over the world are closely watching whether FDA will decide to recall Celebrex and/or Bextra in early 2005. There is a lot of concern about Cox-2 drugs and it is generally believed that they do not provide as many benefits as the risks that they present. (Related article: All Vioxx type Cox-2 drugs under review)

Now another startling revelation shows that Cox-2 drugs may not be all that safe after all. Deramaxx (known generically as deracoxib) is a COX-2 inhibitor approved for relieving arthritis and post-surgical pain in dogs (not approved for humans). It seems that several dogs have died after consuming this drug and its manufacturer, Novartis AG, failed to give the government prompt, accurate reports about the deaths. It is important to point out that Novartis sells a Cox-2 drug called Prexige (lumiracoxib) as an alternative to Vioxx and while the company has temporarily withdrawn the dossier for Prexige from the Mutual Recognition Procedure in Europe to await the outcome of the EMEA cardiovascular safety review of all COX-2 inhibitors, Prexige has been approved in 21 countries to date, including Australia, New Zealand and several countries in Latin America, including Argentina, Brazil and Mexico. (Related article: Novartis offers an alternative to Vioxx)

The FDA, in a warning letter dated Nov. 29, said Novartis Animal Health Services should have forwarded complaints about deaths and health problems in dogs given Deramaxx within 15 working days, but in some cases delayed as long as 10 months. Some reports, including ones involving deaths, appeared to have incorrect dates, the FDA said. The company also failed to submit proper information about post-approval studies of Deramaxx, the FDA charged. While this new information has no bearing on the ongoing review of Celebrex and Bextra, but it does show that Cox-2 drugs need to be evaluated more carefully and in the meantime, these drugs should be recalled.

Recommended article: Vioxx recall makes drug agencies worldwide more careful

Patients retaliate against drug companies

Drug companies are fighting back after their credibility is under serious doubt. While Merck declares that its value is "Our business is preserving and improving human life," the company actually did not recall Vioxx for as many as four years. It neither preserved life nor did it improve it as tens of thousands of victims worldwide suffer from severe side effects of Vioxx.

Similarly, Pfizer, the maker of drugs like Celebrex and Bextra (both of which have been shown to cause enormous damage to the heart), also claims that its mission is, "We dedicate ourselves to humanity's quest for longer, healthier, happier lives." But the ferocity with which Pfizer has defended Celebrex despite calls from the medical community for immediate recall of Celebrex clearly shows that corporate profits are more important than human lives.

But when drug companies and the FDA do not do their job of saving human lives, doctors and patients themselves are taking charge. After the recall of Vioxx, most arthritis patients switched to Celebrex or Bextra. But bad news did not stop with the recall of Vioxx in September. In December, more disturbing data was disclosed about both Bextra and Celebrex and even Aleve was found to be a problem drug. As a result, patients are now switching to other alternatives though it is true that there are very few choices left. (Related article: What should Vioxx/Celebrex/Bextra patients do?)

According to ImpactRx, Celebrex's share of new prescriptions in its market of painkillers dropped Dec. 22 to 4 percent, down from 13 percent on Dec. 16, the day before the company announced the drug's troubles. Prescriptions for the less popular Bextra also are plummeting. On Dec. 22, it accounted for just 2 percent of the painkiller market, down from 6 percent on Dec. 16.

Many experts have argued in the past that Cox-2 inhibitor drugs (e.g. Vioxx, Ceoxx, Celebrex, Bextra, etc.) do not provide any additional benefits than those already available from over-the-counter pain killers. Plus, a recent study has pointed out that acupuncture is another excellent solution for pain. These are the options that patients are exploring. (Related article: Like Vioxx, Bextra and Celebrex may eventually need to be recalled)

On a rather interesting note, when Michael Moore, the famous film-maker declared that he was going to make a documentary to expose how the drug firms put profits ahead of human lives, the drug companies have reacted fast by telling their employees not to cooperate with him or his crew. "We ran a story in our online newspaper saying Moore is embarking on a documentary and if you see a scruffy guy in a baseball cap, you'll know who it is," said Stephen Lederer, a spokesman for Pfizer Global Research and Development.

The drug companies have connections in high places in Washington and literally everyone in the administration and at the FDA owes them a favor, but it is only when American people will fight back will the drug industry change. Americans know that profits are important and some drugs will not work out as well as expected but when drug companies like Pfizer and Merck demonstrate total disregard for their patients, they have no other choice but to fight back. (Related article: Americans may soon lose their right to sue drugmakers for manufacturing killer drugs)

And it is pretty obvious that Americans are not just filing class action lawsuits because they enjoy doing so. It is that drug companies have literally left them with no choice than to join Vioxx class action lawsuits.

Recommended article: Celebrex lawsuits follow the Vioxx class action lawsuits approach

Celebrex, like Vioxx, should be recalled

If you go back to study the Vioxx recall story, there is overwhelming evidence that as early as 2000, Merck knew that Vioxx was a killer drug. And this information was not confined to Merck employees. In fact, the medical community was talking about the adverse cardiovascular side effects of not only Vioxx, but all COX-2 inhibitor drugs as early as 1998. That means that FDA employees must have known that Vioxx was killing and injuring Americans. Dr. Eric Topol, the world-famous cardiologist, has been arguing for putting patient safety over drug company profits for years and had called for withdrawal of Vioxx years ago. However, Merck, with the collaboration of its friends at the FDA (and the support of politicians, largely Republicans, who received campaign contributions from drug companies), was able to keep Vioxx on the market till September 2004, leading to tens of thousands of deaths of Americans (and citizens of other nations) and even more seriously injured. (Related article: Merck vows to fight Vioxx class action lawsuits vigorously)

Both FDA and Pfizer are repeating the same story with Celebrex and Bextra. Last week, like always, FDA again failed to act and merely issued an advisory rather than ask for a recall of Celebrex. It did the same with Bextra earlier this month. Dr. Sidney M. Wolfe, MD, Director, Public Citizen's Health Research Group, a non-partisan consumer rights group says, "The FDA is once again siding with a large pharmaceutical company, in this case Pfizer, in refusing to ban the two Pfizer COX-2 selective drugs Celebrex and Bextra. Although there was evidence that Vioxx, now off the market because of significantly increased risks of heart attacks and strokes, was protective to the gastrointestinal tract compared one older drug, there is no such credible evidence for either Celebrex or Bextra. Both Celebrex and Bextra are doomed drugs that are in the twilight of their existence. Breathing extra live into them is surely beneficial to Pfizer executives and stockholders but is a step backward for an agency that is supposed to be part of the Public Health Service...Removing Celebrex from the market will be a major step forward for public health." (Related article: Merck's attack on Vioxx victims helps its stock price recover)

The Europeans are, however, frustrated with how arrogant the drug companies are and how little concern they have for human life. It is pretty obvious that both Merck and Pfizer are more concerned about their profits and stock price rather than about saving human lives. Thomas Lonngren, executive director of the European Medicines Agency, has written a letter to Dr Franz Humer from Roche, the current president of the EFPIA, saying that the heads of national medicines agencies in the European Union contacted Merck over 'the failure of communication about the withdrawal of Vioxx'. Lonngren expressed concern that Merck had contacted regulators in the EU as little as two hours before it made a public announcement withdrawing Vioxx, which sharply depressed the company's share price. He also accused drugs companies this autumn of favouring shareholders' financial health over public health. The EMEA will review on an expedited basis the full clinical trial data and further information on COX-2 inhibitors in January 2005. (Related article: Why Merck did not recall Vioxx earlier?)

Many doctors are not yet convinced that Vioxx, Celebrex, and Bextra do anything more than what an over-the-counter pain killer does. Many doctors even call these drugs as "glorified aspirins" whose benefits are highly overrated through slick direct-to-consumer advertising. No surprise then that the three Cox-2 inhibitors earned $5.3 billion in sales last year. More than all over-the-counter painkillers. This makes it very difficult for Pfizer to recall Celebrex and Bextra. And the FDA and the Bush administration, full of drug industry insiders and sympathizers that have benefited enormously through millions of dollars in campaign contributions, are expected to favor the drug companies over American lives. In fact, things for the drug industry are expected to get even better next year when Americans will lose their rights to sue drugmakers for making killer drugs.

Recommended article: What should Celebrex and Bextra patients do after Vioxx recall?

FDA limits Celebrex & Bextra use due to Vioxx scare

The Food and Drug Administration (FDA) today issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. The public health advisory is an interim measure, pending further review of data that continue to be collected. A final decision is expected in February 2005 when an advisory committee meeting is planned and will provide an opportunity for a full public discussion of these issues. In the meantime FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen (sold as Aleve), and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed. (Related article: Vioxx recall has made health agencies worldwide more cautious about adverse side effects of painkillers)

In addition, FDA today announced that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents Celebrex (celecoxib) and Bextra (valdecoxib) to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition (such as colon polyps or Alzheimer's disease). (Related article: Pfizer refuses to voluntarily withdraw Celebrex)

FDA is issuing an advisory because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings (immediately after heart surgery).

Also, as FDA announced earlier this week, preliminary results from a long-term clinical trial (up to three years) suggest that long-term use of a non-selective NSAID, naproxen (sold as Aleve, Naprosyn and other trade name and generic products), may be associated with an increased cardiovascular (CV) risk compared to placebo.

Although the results of these studies are preliminary and conflict with other data from studies of the same drugs, FDA is making the following interim recommendations: (Related article: Celebrex aggressively marketed by Pfizer after Vioxx recall)

• Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), should consider this emerging information when weighing the benefits against risks for individual patients.
• Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for Cox-2 selective agents.
• Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account for each prescribing situation.
• Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions.
• If use of an (OTC) NSAID is needed for longer than ten days, a physician should be consulted. Non-selective NSAIDs are widely used in both over-the-counter (OTC) and prescription settings. As prescription drugs, many are approved for short-term use in the treatment of pain and primary dysmenorrhea (menstrual discomfort), and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis.

Recommended article: Celebrex lawsuits follow the Vioxx class action lawsuits approach

Post Vioxx recall - safe use of over-the-counter pain relief drugs

After the recall of Vioxx and posting of warnings related to Bextra, Celebrex, and Aleve, attention has been focused on a range of painkillers. Since most painkillers are available over-the-counter and Americans consume pills without thinking much about their serious adverse side effects, in January of 2004, FDA had started a campaign to provide advice on the safe use of over-the-counter (OTC) pain relief products.

"Pain relievers and fever reducers are safe drugs when used as directed, but they can cause serious problems when used by people with certain conditions or those who are taking specific medicines," said the then FDA Commissioner Mark B. McClellan, M.D., Ph.D.. "We want to remind consumers who take these products that it's important to follow current dosing and label directions carefully."

FDA's nationwide campaign focuses on the over-the-counter (OTC) pain and fever reducers that contain acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), which include products such as aspirin, ibuprofen, naproxen sodium and ketoprofen.

"Read labels carefully, be sure you are getting the proper dose, and check with your doctor or pharmacist to be sure that you can use these drugs safely," said Dr. McClellan.

Many OTC medicines sold for different uses have the same active ingredient. For example, a cold-and-cough remedy may have the same active ingredient as a headache remedy or a prescription pain-reliever. To minimize the risks of an accidental overdose, consumers should avoid taking multiple medications that contain the same active ingredient at the same time.

Acetaminophen is an active ingredient found in more than 600 OTC and prescription medicines, such as pain relievers, cough suppressants and cold medications. It is safe and effective when used correctly, but taking too much can lead to liver damage, and even death. The risk for liver damage may be increased in consumers who drink three or more alcoholic beverages per day while using acetaminophen-containing medicines.

NSAIDs are common pain relievers that are also used to relieve fever and minor aches and pains. Examples of NSAIDs are aspirin, ibuprofen, naproxen sodium, and ketoprofen. These products can cause stomach bleeding with an increased risk in consumers who are over 60, are taking prescription blood thinners, are taking steroids or have a history of stomach bleeding. NSAIDS may also increase the risk of reversible kidney problems in consumers with preexisting kidney disease, or who are taking a diuretic (water pill). (Related article: Treatment options for pain relief)

In September 2002, FDA's Non-Prescription Drugs Advisory Committee recommended changes to labeling of certain OTC drug products, including acetaminophen and NSAIDS. They advised that these changes are needed to better inform consumers about the ingredients in these products and possible side effects caused by improper use. In addition to this new consumer outreach effort, FDA will consider changing the labeling of these products to further bolster their safe use. FDA is reviewing various changes to labeling for these ingredients that better reflect the latest scientific knowledge about OTC oral pain relievers.

Recommended article: Americans are more careful about drugs after Vioxx recall

Celebrex lawsuits follow the Vioxx lawsuit approach

Heart-broken family members of those killed by Vioxx are currently trying to evaluate their legal options with Vioxx attorneys and determining if they should join class action lawsuits filed against Merck. Those that have been injured by Vioxx are in the same situation. These are not easy times for these people particularly with the holidays around. (Related article: Attorneys soothe the frayed nerves of Vioxx victims)

Now it seems that Pfizer may be subject to class action lawsuits with regards to Celebrex. While no definitive data is available yet if Celebrex caused deaths (Vioxx reportedly killed tens of thousands of people worldwide), but recent studies indicate that Celebrex increases the risk of heart attacks. And these are the people who are looking to join class action lawsuits. CTV and Associated Press are reporting that Celebrex class action lawsuits are already being filed against Pfizer in the United States. Now a Toronto law firm has launched a $1.5 billion class-action lawsuit against Pfizer on behalf of all Canadians who took Celebrex. The firm McPhadden Samac Merner Darling, which is launching the suit, is claiming that Pfizer misrepresented information about its drug. The lead plaintiff is a Mississauga, Ontario woman who claims she lost earnings after developing an irregular heartbeat and cardiovascular problems after taking Celebrex. (Related article: Pfizer reaffirms safety of Celebrex)

Apart for Vioxx class action lawsuit plaintiffs, Celebrex class action lawsuits plaintiffs have a lot of company from Pfizer shareholders and 401(k) retirement plan participants because of possible violations of the Employee Retirement Income Security Act of 1974 (ERISA). Emerson Poynter LLP; Stull, Stull & Brody; Murray, Frank & Sailer LLP; Keller Rohrback L.L.P. Johnson & Perkinson; Finkelstein, Thompson & Loughran; Wolf Haldenstein Adler Freeman & Herz LLP; and Schatz & Nobel, are some of the Celebrex attorneys in the process of either getting ready for securities related lawsuits against Pfizer or have already filed complaints with the courts in the United States. In other words, it seems that there is already reasonable evidence against Pfizer that it may have provided misleading information about its drugs to both patients and shareholders.

How to find a Celebrex attorney?

Since there are a lot of similarities between Vioxx and Celebrex (they are both Cox-2 drugs), and even more obvious similarities in how Merck and Pfizer have handled the situation, many Vioxx attorneys are also starting to take on Celebrex cases. It may be important to note that since Vioxx has been recalled and it is well established that tens of thousands of Vioxx patients are either dead or seriously injured, the case against Vioxx manufacturer Merck is very strong. On the other hand, the FDA is still evaluating if Celebrex should be recalled. If Celebrex is recalled, then case against Pfizer will be much stronger.

In the meantime, you may want to discuss your case with an attorney, particularly if you switched from Vioxx to Celebrex. Quick action in this matter is important because when Congress starts its new session in January 2005, it is likely to take Class Action Reform Act being proposed by President Bush that will take away the right of American people to sue drugmakers even if they make deadly drugs.

Recommended article: How to find a good Vioxx/Celebrex attorney?

Vioxx recall makes health agencies worldwide more careful

Governments and health agencies all over the world are responding to the disturbing data about several other drugs in the Cox-2 category since the recall of Vioxx. Aleve, which is not a Cox-2 drug, but is still used for pain relief, is not being reviewed yet as agencies focus more on drugs like Celebrex.

Most governments are responding to the data released in the United States since Vioxx was withdrawn by Merck in September. The FDA is also in the process of making up its mind about Celebrex and a decision is expected any day. Most analysts expect that FDA will simply change the warning on Celebrex without actually asking for an outright recall of Celebrex. Another group of analysts believe that FDA, which has been widely criticized for failing to react fast to disturbing data, might actually recall Celebrex just to be safe this time. The FDA has been without a full-time head for years now and the agency is in complete disarray. Many experts also believe that the FDA has been hijacked by the drug industry considering the fact that industry insiders now control not only the agency but the current administration as well.

But governments in other countries, where the government agencies and drug industry do not have such cozy relationships, are moving fast to protect the health of their citizens. Victims of drugs like Vioxx are also filing class action lawsuits against Merck as well and that has put a lot of pressure on these agencies not to let another Vioxx scandal happen this time.

Pharmac (a government agency in New Zealand) yesterday accused Pfizer of continuing to aggressively promote Celebrex to doctors despite the withdrawal of Vioxx and similar concerns being raised about its own drug. The company has refused to recall Celebrex though it has discontinued its direct-to-consumer advertising at the request of the FDA. Pfizer is however aggressively promoting the drug to doctors and is continuing to stand by its safety despite conflicting data about its adverse side effects.

In the meantime, Health Canada, the equivalent of the FDA, has informed Canadians of safety concerns regarding selective COX-2 inhibitor NSAIDs (non-steroidal anti-inflammatories). These include Vioxx (rofecoxib), which has been withdrawn from the market, Celebrex (celecoxib), Bextra (valdecoxib), and Mobicox (meloxicam), which are used in the treatment of symptoms of rheumatoid arthritis, osteoarthritis and primary dysmenorrhea (menstrual pain).

Accumulating evidence indicates that the use of selective COX-2 inhibitor NSAIDs, in certain individuals, is associated with an increased risk of heart attack or stroke when compared to placebo. The risk appears to increase with the total daily dose and the length of the treatment. However, given the available data, it is not possible to identify which patients would present a higher risk of heart attack and stroke. (Related article: Aleve is also being watched carefully after recall of Vioxx and disturbing data about Celebrex)

Health Canada has requested additional safety information from the manufacturers of Celebrex, Bextra, Mobicox and generic forms of meloxicam, and will continue to review the safety profile of these drugs in order to fully consider what is presently known about the risks and benefits of these drugs when used according to their labeling.

"Until further information from long-term clinical trials becomes available, one should consider that there is a strong possibility of an increased risk of cardiovascular events, including heart attack and stroke, when using selective COX-2 inhibitor NSAIDs", Health Canada warns people.

It should be noted that alternative therapies to selective COX-2 inhibitor NSAIDs also present risks. This is particularly true after it was found that Aleve, an alternative used for Vioxx, also has serious side effects if one exceeds the recommended dosage and takes it for more than 10 days at a time. Therefore, patients should discuss with their physician all benefits and risks of selective COX-2 inhibitor NSAIDs versus alternative therapies, in order to determine the most appropriate treatment in their individual case. A recent study indicates that acupuncture may provide enormous pain relief.

The Department of Health in the UK is also asking patients who are taking Celebrex, Bextra and Arcoxia that they should make a non-urgent appointment with their doctor to review their treatment.

The Therapeutic Goods Administration (TGA), the equivalent of FDA in Australia, has now fast tracked the review of Cox-2 drugs requesting that the US research data be provided to the Australian regulator immediately and reinforcing to all other companies researching Cox-2 Inhibitors to produce their results as a matter of urgency. Australian Adverse Drug Reactions Committee (ADRAC) has advised that all drugs in the class of Cox-2 inhibitors should be regarded as having an increased cardiovascular risk until more is known.

Recommended article: What should Celebrex and Bextra patients do if they are recalled?

Merck has invited Vioxx class action lawsuits

Yes, that is what Merck has done since it got the approval of Vioxx and learned as early as 2000 that there were very serious adverse side effects from the drug. And Pfizer is doing it as we speak and is literally asking people to get ready to file Celebrex class action lawsuits. While the drug companies may blame Americans for being obsessed with class action lawsuits, were it not for their negligence, no one would waste their time going to a court.

As is very apparent to Vioxx victims, Merck has been aggressively attacking its past customers (those who took Vioxx) by telling them that they will not get a penny out of it and that it will do everything it can to make sure that Vioxx lawsuits do not get class action status. At the same time, Bush administration is about take away the rights of Americans to file class action lawsuits and shield drug makers from having to pay anything more than $250,000 even when it's proven that they negligently caused someone more than $250,000 of harm. Or in other words, this will end lawsuits against drug companies because personal-injury lawyers won't want to take on the risks and costs of such cases. If this bill passes, companies like Pfizer and Merck, now facing a flood of lawsuits because of Celebrex and Vioxx, won't have to worry. No wonder Pfizer is happily singing the glory of Celebrex while disturbing data about the drug continues to come out.

So does it still mean that Americans have nothing better to do than to file class action lawsuits? At least that is the impression you get if you hear the sales pitch for tort reform from the White House. In the case of Vioxx, it is no secret that tens of thousands of Americans have died and even more seriously injured simply because, as Dr. Eric Topol points out, Merck thought profits were more important than human life (and that too in a country where Americans are obsessed with the sanctity of life).

So it is not that Americans enjoy being in courts and filing lawsuits, it is that companies invite them to do so by not valuing the lives and health of Americans. Americans are smart enough to understand that mistakes will happen, particularly with new drugs, and some people might get ill and even die. But what shocks Americans is that a company will knowingly keep a deadly product on the market, as Merck did. And that too for as long as four years, according to research conducted by The Wall Street Journal.

So if you want to better understand why class action lawsuits are filed and have missed how the Vioxx recall story unfolded, just watch carefully how the Celebrex "recall" story is unfolding. Celebrex, like Vioxx, is a Cox-2 drug, and while conclusive evidence is not yet available to show if it as dangerous as Vioxx, there is some evidence to indicate that Celebrex increases the risk of heart attacks. Knowing this, Pfizer started an aggressive direct-to-consumer advertising campaign the same day Vioxx was recalled. Since then, in statement after statement (both written and in interviews by Pfizer executives) the company has tried to affirm the safety of Celebrex.

So what will happen when a study in the future might conclusively show that Celebrex is indeed a deadly drug? Like Merck, Pfizer might also end up attacking Celebrex patients, rather than apologizing for its unethical business practices. What other option will Americans have at that point if not to file Celebrex class action lawsuits? But by that time, Americans might very well lose their right to do so if the Bush administration has its way.

Recommended article: Celebrex safety concerns good news for Vioxx class action lawsuits

What should Vioxx alternative Aleve patients do?

On December 20, the Food & Drug Administration issued an announcement advising people who take an over-the-counter painkilling drug called naproxen (sold as Aleve) to pay attention to instructions on the label and not exceed the maximum recommended dose of 220 milligrams twice daily for more than 10 days without consulting a physician. (Related article: Treatment options for Vioxx patients)

University of Michigan (U-M) physician Mark Fendrick, M.D., agrees that's excellent advice. Fendrick, a University of Michigan physician and professor of internal medicine in the U-M Medical School, has studied the use of non-steroidal anti-inflammatory drugs (NSAIDs) like naproxen and ibuprofen. These are two over-the-counter drugs that have been prescribed for many patients after the recall of Vioxx and warnings about Celebrex and Bextra.

“Long-term use of any non-steroidal anti-inflammatory medication can be dangerous and requires supervision by a medical professional,” Fendrick says. “Anyone taking over-the-counter NSAIDs for chronic pain or inflammation should consult their doctor. People taking these drugs for occasional, intermittent pain should be careful not to take more than the recommended dose.” (Related article: Vioxx type Cox-2 drugs face an uncertain future)

The FDA announcement came in response to the decision by the National Institute of Aging to halt a clinical trial in which non-steroidal anti-inflammatory drugs were given to patients at risk of developing Alzheimer's disease. Preliminary information from the study showed some evidence of higher risks of heart attacks and strokes in patients taking naproxen.

“The FDA's announcement was not a recall. It's just a cautionary statement to patients taking Aleve until full data from the clinical trial can be evaluated,” Fendrick adds. “Given the recent media firestorm surrounding this class of drugs, all chronic NSAID users – OTC and prescription – should discuss the benefits and potential risks of these agents with their physicians to determine the treatment plan which is best for that individual. Hopefully, more information will be forthcoming soon from the FDA regarding the long-term use of naproxen when prescribed by a physician. Until then, I would not suggest that people stop taking their medications.”

Recommended article: Vioxx alternatives Celebrex and Bextra may need to be recalled

Vioxx type drugs under review in New Zealand

An expert committee in New Zealand, The Medicines Adverse Reactions Committee, reviewing the safety of a group of arthritis drugs called COX-2 inhibitors has reinforced the advice given in the UK, Germany, and other countries, cautioning against their routine use where safe and effective alternatives are available. Merck recalled Vioxx when it was found to cause tens of thousands of deaths and increased risk of heart attacks in many more. Since then Celebrex and Bextra have come under increasing scrutiny due to their adverse side effects. Aleve, another non-prescription alternative to Vioxx, has also been found to increase risk of heart complications if taken for more than 10 days or in higher dosage than recommended.

The Medicines Adverse Reactions Committee is advising patients who are using Celebrex, Arcoxia, Mobic and Bextra they should talk with their health care provider about alternatives if they have concerns. Like elsewhere in the world, Vioxx was withdrawn by Merck Sharp and Dohme in New Zealand on September 30, 2004. The Medicines Adverse Reactions Committee (MARC) has discussed a rapid literature review of the risk of use of COX 2 inhibitor medicine causing increased risk of cardiovascular events (heart attacks and/or stroke). (Related article: Pfizer reaffirms safety of Vioxx alternative Celebrex)

The MARC concluded that the increased risk of heart attack found for rofecoxib (Vioxx) may also occur to some degree for all of the other members of the COX 2 group of anti-inflammatory agents. The MARC conclusion is supported by the subsequent report from the United States National Institute of Health that it had stopped one of two long-term (3 years) studies of celecoxib (Celebrex) in the prevention of colon polyps due to an increased risk of cardiovascular events. The increase in cardiovascular risk was similar in size to the 1.96 times increased risk found after 18 months treatment in the Vioxx study of colon polyp prevention that lead to Vioxx being removed from the market in October of this year.

The Adenoma Prevention with Celebrex study (APC) that has been stopped found that patients taking celecoxib (Celebrex) at doses of 200mg twice a day and 400mg twice a day have an increased risk of developing a cardiovascular event compared to patients on placebo of 2.5 and 3.4 times respectively. While the average duration of treatment in the APC study was 33 months when it was stopped, the available data does not indicate when the increased cardiovascular risk first becomes apparent. A parallel study of celecoxib (Celebrex) using 400mg once per day as a preventative agent for colon polyps for a similar period of time has not shown increased risk. (Related article: Pfizer refuses to recall Celebrex despite safety concerns)

In October 2004 the New Zealand Ministry of Health (Medsafe) asked the manufacturers of COX 2 medicines to supply it with all the data they hold on the cardiovascular safety of these medicines. Like other medicines regulators around the world, Medsafe is in the process of reviewing the massive volumes of data supplied by the manufacturers to determine if use of a COX -2 medicine increases the risk of a patient developing a cardiovascular event. This analysis is unlikely to be completed before March 2005.

The MARC key messages are:

• COX 2 agents are not recommended for routine use in patients with rheumatoid arthritis (RA) or osteoarthritis (OA) except in circumstances where the patient is at "high risk " of developing a serious gastrointestinal adverse effect from other standard non-steroidal anti-inflammatory agents;
• COX 2 agents should not be routinely prescribed to patients at high risk of cardiovascular events (absolute risk of event >15-20% over 5 years) as there remains uncertainty about the safety of these agents when used in this group of patients;
• Prescribing COX-2 agents to patients already taking aspirin cannot be justified on current evidence.
• The increased benefit associated with use of COX 2 agents in patients at high risk of serious gastrointestinal adverse effects (estimated as between a 4 and 8 times reduction in serious events), may outweigh the increased risk of cardiovascular events in patients at high risk of myocardial infarction.
• A signal is emerging that use of some COX 2 agents as painkillers after major surgery may be associated with an increased risk of cardiovascular events. The MARC therefore advises that until the full evaluation of all the safety data is complete COX 2 agents should not be routinely used for post-operatively pain relief.
• Patients already taking COX 2 agents should discuss the continuing use of these medications with their doctor, or specialist, the next time their prescription is due.
• Prescribers should discuss with their patients the available alternatives to the COX 2 agents and review the risks and benefits of these alternatives compared with the emerging clinical concerns about the COX 2 agents, before deciding on the best course of treatment for that individual. If the patient and prescriber decide that continued use of a COX 2 agent is appropriate, use of the lowest effective dose is prudent practice.

If patients are taking COX 2 agents on a regular basis and are concerned about their use of these medicines, they should discuss the risk and benefits of continued treatment with their healthcare provider. A number of alternative anti-inflammatory agents for the treatment of osteoarthritis and rheumatoid arthritis are available in New Zealand. Unlike the COX 2 agents, many of these agents are funded by PHARMAC.

Recommended article: Safety of Vioxx alternative Bextra questioned by US Senate

Pfizer reaffirms safety of Vioxx alternative Celebrex

The data released by the The National Institutes of Health that warned about the cardiovascular (heart-related) complications due to naproxen (sold as Aleve) had another interesting piece of data - that there was no increased cardiovascular risk seen in elderly patients taking Celebrex (400 mg daily) for up to three years. This is slightly different from the findings of the NIH in a separate study that found that Vioxx alternative, Celebrex, increased the risk of heart attacks. (Related article: Vioxx alternative Aleve found to cause heart problems)

This is a position that Pfizer has been taking all along, though many scientists and the FDA are very concerned about the safety of Celebrex. "It would be premature to say what we are going to do with either one of these drugs, Celebrex or Aleve," Food and Drug Administration Commissioner Lester Crawford said. "We will keep all regulatory options open and make some determinations as quickly as possible based on the data." It is important to mention that since the recall of Vioxx, the FDA has been widely criticized for not doing its job, which resulted in tens of thousands of Vioxx-related deaths and injuries.

In a press release, Pfizer said, "These results are consistent with the large body of Celebrex scientific evidence that has accumulated over 10 years in more than 40,000 patients." Since release of data questioning the safety of Celebrex, Pfizer has pulled all direct-to-consumer advertising but has refused to recall Celebrex. “This is important new information that should be considered by doctors and patients as they evaluate the various treatments for arthritis and pain,” said Hank McKinnell, chairman and chief executive officer of Pfizer. “Millions of people simply can’t get through their day without pain relief. That’s why all the emerging information about arthritis medicines—prescription and over-the-counter—must be fully evaluated by the U.S. Food and Drug Administration and other regulatory authorities." (Related article: Treatment options for Vioxx patients)

“Recently, preliminary information from three major long-term clinical trials with Celebrex has become available. Because the early information from these trials is inconsistent, physicians and patients are understandably confused. T