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.net)
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. That’s why the full study results must be shared with the medical, scientific and regulatory experts so that we have a more complete understanding of the risks and benefits of these medicines,” McKinnell said. (Related article: Safety concerns about Celebrex may be good news for those Vioxx victims who have joined class action lawsuits against Merck)

Pfizer recommends physicians consider alternative therapies when choosing an arthritis and pain medication for their patients. Celebrex remains one of these treatment options for osteoarthritis, rheumatoid arthritis and acute pain and, according to good medical practice, should be administered at the lowest effective dose for appropriate patients. (Related article: Acupuncture may help with pain relief and is an option for Vioxx patients)

"This is a very confusing situation," said Dr. Sandra Kweder, deputy director of the Food and Drug Administration Office of New Drugs. But the FDA stopped short of urging patients to seek alternatives to Aleve, its generic versions or its prescription forms Naprosyn and Anaprox, as the agency had done Friday with Celebrex.

Recommended article: Celebrex has been aggressively marketed since recall of Vioxx

Vioxx alternative Aleve found to cause heart problems

Vioxx patients who may have heard the news about the warning issued by the FDA and the National Institutes of Health (NIH) today should not panic. If your doctor has switched you to Celebrex (which incidentally is a drug that is being closely watched by the FDA and a decision is imminent on whether to recall Celebrex after it was found that it increased the risk of heart attacks) or any other drug, then you should simply go back to your doctor, particularly if you have been taking naproxen (marketed as Aleve in the United States). (Related article: Problems with all drugs like Vioxx may bolster the case of Vioxx victims in class action lawsuits)

As you know, Aleve is an over-the-counter drug found in the drug cabinet of every home. While it may be much less expensive than Vioxx or any of the other drugs like Vioxx, it is fairly effective for controlling pain. Naproxen was first sold as a prescription drug under the trade name Naprosyn in 1976. FDA approved its use as an over-the-counter drug in 1994.

What NIH and the FDA found in a totally different study that had nothing to do with arthritis was that two drugs that have been used as alternatives since the recall of Vioxx, naproxen (220 mg twice a day and commonly sold as Aleve) and celecoxib (200 mg twice a day, commonly sold as Celebrex), was that there was an apparent increase in cardiovascular and cerebrovascular events among the participants taking naproxen when compared with those on placebo. In simple words, Aleve, like Vioxx may be bad for your heart. (Related article: Treatment options for Vioxx patients)

It is very important to understand that neither drug has been pulled off the market yet and this is merely a warning. As indicated on the Aleve label, the FDA says, you should not take the drug for more than 10 days and in higher dosage than recommended on the label, and if you need to do so, you need to speak to your doctor, even though naproxen is an over-the-counter drug. If you are taking Aleve in place of Vioxx, you should not do so without the recommendation of your doctor.

“This step is being taken as a precautionary measure to ensure the safety of the study’s participants,” said NIH Director, Elias A. Zerhouni, M.D. “The investigators made their decision based on the risk/benefit analysis specific to this trial,” added Dr. Zerhouni.

Investigators and NIH scientists will continue to review this and other NSAIDs studies sponsored by NIH in the light of these findings. It should be pointed that the cancer prevention trials and the ADAPT study are among the first long-term, clinical trials to test these classes of drugs. These studies are examining these compounds for uses very different from the uses for which these medications are currently approved. NIH and FDA will work together to provide the public with information they need to make informed health decisions. (Related article: Vioxx alternative Celebrex faces an uncertain future)

At this time, a decision is still awaited from the FDA on what to do with the other Vioxx alternative, Celebrex.

Recommended article: Bextra and Celebrex may need to be recalled

Treatment options for Vioxx patients

Since the recall of Vioxx, much of the discussion has been focused on how Merck may have hidden damaging information about the drug and how Merck's action resulted in tens of thousands of people dead worldwide. Plus, there is heated discussion about Vioxx class action lawsuits. But what has not received enough attention is what to do next if you are a Vioxx patient. This question has assumed even more importance after the problems discovered with Celebrex and earlier warnings issued about Bextra.

Dr. Mark Fendrick, Co-Editor in Chief of The American Journal of Managed Care, writes that these innovative drugs in the COX-2 family were never intended to provide pain relief superior to that of traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Rather, the COX-2 selective inhibitors were meant to reduce the risk of gastrointestinal adverse events, common with NSAIDs, while affording patients symptomatic relief comparable to that of the NSAIDs. He continues, "Thus, the use of the available treatment alternatives in the "post-Vioxx" era must balance competing risks and benefits." In other words, what Dr. Fendrick is saying is that an Aspirin can do the trick, though that too has some side effects, though not as severe as those of Vioxx and others which significantly increased the risk of heart attacks.

Authorities in Europe, Canada, and Australia are reviewing the data on Cox-2 drug to determine if all drugs in this category should be withdrawn. The FDA in the United States is slated to announce its decision on Celebrex this week and on Cox-2 drugs early next year. But almost all doctors in the United States are now skeptical about the safety of Cox-2 drugs, and even more so about the risk-benefits tradeoff. This is an important point because a point very strongly being made by Pfizer is that Celebrex, despite its serious adverse side effects, is still a great drug and, therefore, there is no reason to recall Celebrex.

Dr. G A Fitzgerald writing in the New England Journal of Medicine does not seem to agree with that logic. He has said in the past that, "The burden of proof now rests with those who claim that this is a problem for rofecoxib (Vioxx) alone and does not extend to other coxibs. We must remember that the absence of evidence is not the evidence of absence."

Dr. Frendrick adds, "In light of the Vioxx withdrawal and the subsequent reassessments of COX-2 agents underway to definitively establish cardiovascular safety, clinicians should balance the benefits and risks of available agents in terms of pain relief and cardiovascular and gastrointestinal safety. Until the burden of safety is met, we should consider taking our patients "back to the future" and use older, well-studied agents to safely provide symptomatic relief." The FDA, in the meantime, has rather simple advice to former Vioxx patients: Talk to your doctor.

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

Pfizer refuses to recall Vioxx alternative Celebrex

This weekend was not a quiet one after the news Friday that Celebrex, like Vioxx, also caused major heart problems. It is expected that the FDA will make an announcement on the fate of the drug sometimes this week. Most analysts expect that FDA will ask Pfizer to recall Celebrex. Lester Crawford, head of the Food and Drugs Administration, the US medicines supervisor, told the Financial Times of London in an interview, “We are looking at all the Cox-2s and will make an announcement shortly. All the regulatory options are open. . .including withdrawal. . .I have serious concerns about Cox-2s as a class.” Most experts believe that a recall of Celebrex at this time is the right thing to do considering that tens of thousands of people are already dead from Vioxx and there is enough evidence against Celebrex.

It is indeed correct, as the Pfizer CEO kept pointing out this weekend, that the data is not conclusive and Celebrex and Vioxx are two different drugs despite belonging to the same class of drugs, but when it comes to health of people, it is better not to play with their lives, as Merck decided to do.

It was generally expected that after the flawed Vioxx recall strategy pursued by Merck, Pfizer will be wiser and pull the drug immediately, apologize to its customers, and announce a compensation program, but it is evident that Pfizer is actually following an identical strategy. In fact, it almost appears that the two companies are coordinating their campaigns.

In a report in The New York Times, however, Pfizer has announced that it will suspend all direct-to-consumer advertising immediately (though some ads may still be seen in the print media due to the time delays involved). The company will continue to market the drugs to doctors and advise them of adverse side effects so that they can prescribe the drug more carefully. (Related article: Vioxx recall leaves drug advertising unchanged)

It may be pointed that Pfizer, like Merck, is also a very aggressive direct-to-consumer marketer and embarked on an aggressive advertising campaign (the company had already spent as much as $71 million in the first 9 months of 2004) for Celebrex after the recall of Vioxx in late September. Pfizer is also notorious for misleading ads and FDA had to step in a few times to stop some of Pfizer's ads from running.

While this confusion about drugs has made Americans very nervous, the White House is perfectly pleased with the situation. In fact, Andrew Card, the White House chief of staff, said, "I support the FDA. They do a spectacular job. When you think about all of the new technologies and the new drugs that are coming into the marketplace, and they have to review them all to make sure that when they come into the marketplace, they live up to the expectation of improving health care." Looks like the view from the White House is quite different since tens of thousands of Americans are dead due to Vioxx because the FDA failed to protect the lives of Americans. Many more Vioxx victims are seriously injured. (Related article: White House to push for legislation that will take away the rights of Americans to file class action lawsuits)

Senator Edward Kennedy captured the mood of Americans who are disappointed by the lousy performance of the FDA and lack of accountability in the administration. He said, "I know that this is the Administration that never admits a mistake, but its record on protecting us from harmful prescription drugs is a catastrophic failure. We need an FDA that looks out for the health of patients and not just the health of the pharmaceutical industry. Lives are at stake, and the President should put an FDA leadership team in place right away, with no ties to the industry it regulates, and that's committed to reform. Early action on bipartisan FDA reforms is possible in Congress, and I hope that the White House and congressional leadership will not stand in the way."

Recommended article: Vioxx attorneys soothe the nerves of scared victims

Vioxx alternative Celebrex faces uncertainty

Health Canada, the equivalent of Food & Drug Administration in the United States, has responded to new data about the cardiovascular risks of Celebrex by recommending to Canadian doctors that Celebrex should not be taken for the prevention of recurrence of Familial Adenomatous Polyposis and patients should discuss alternative therapeutic options with their doctors. Similar recommendation has been made by the FDA in the United States and it is widely expected that Celebrex will be either recalled by Pfizer under pressure from the FDA or FDA will ban the drug.

Health Canada also advises patients who are on long-term 400 mg daily doses of Celebrex to discuss alternative therapies with their physician. The agency has notified Pfizer that the market authorization for the use of Celebrex for the prevention of recurrence of Familial Adenomatous Polyposis has been withdrawn. Health Canada will shortly issue further advice concerning the safety of selective COX-2 inhibitor NSAIDs. The German authorities have already restricted prescription requirements for Cox-2 drugs.

The Australian Medical Association (AMA) president Bill Glasson, however, says there is no need to pull Celebrex from the Australian market, if doctors continue to prescribe it responsibly. Dr Glasson says that before making any decision to go off the drug, patients should remember that all medications have side-effects and taking them is a calculated risk. He is essentially repeating the statement of the Pfizer CEO Hank McKinnell who has been doing a round of interviews on television stations saying the same thing. He is admitting that Celebrex, like Vioxx, has adverse side effects but as long as patients are made aware of the risks there is no need to recall Celebrex. In that sense, he is taking an approach that is quite different from the one taken by Merck when it recalled Vioxx after it was reported that tens of thousands of people have been killed and countless others injured by Vioxx.

The Therapeutic Goods Administration, the Australian equivalent of the FDA, is, however, reviewing the new data about Cox-2 drugs. It is not yet known if Celebrex will be banned in Australia.

It will be interesting to watch what the FDA does about Celebrex since it is a blockbuster drug for Pfizer and has grabbed literally all the market share since the recall of Vioxx. Merck stock has taken a serious beating since the recall of Vioxx and similar fate awaits Pfizer if it voluntarily withdraws Celebrex or is forced to do so by the FDA.

Recommended article: Drug approval process reform needed after Vioxx recall scandal

Celebrex safety concern good news for Vioxx victims

The recent announcement by Pfizer that Celebrex also has heart risks (along with a stronger warning about side effects of Bextra) means that arthritis patients have hardly any choice left, but insofar as their class action lawsuits against Merck are considered, this may be great news.

Vioxx attorneys are still digesting the new revelations and assessing how it will affect their legal strategy and a lot will depend on what happens next week when FDA announces its decision whether to recall Celebrex, but there is much stronger evidence now that all drugs in the Cox-2 category (Vioxx, Celebrex, and Bextra) increase the risk of heart attack. (Related article: Vioxx recall focuses attention on all Cox-2 inhibitor drugs)

It may be pointed out that Merck has been relentlessly attacking Vioxx victims during last week or so, primarily to discourage them for filing class action lawsuits against the firm. The main argument that the company has used against awarding class action status to Vioxx lawsuits is that there is no commonality in the cases. In other words, Merck is arguing that Vioxx was not the problem, the people who had heart attacks (or died due to a heart condition) may have other reasons (e.g. smoking, obesity, etc.) for their heart illness. Of course this line of argument incensed Vioxx victims though many victims were also completely scared by Merck's aggressive approach.

The recent announcements about Celebrex and Bextra strengthen the arguments of Vioxx victims that Cox-2 family of drugs have an inherent problem and the drug manufacturers and the FDA were all wrong in giving approval to these drugs. That is what German authorities are arguing as they have restricted prescription of all Vioxx and Celebrex type drugs.

In the meantime, Vioxx victims should simply stay calm and let the events unfold. It is becoming increasingly apparent that drug companies may have dug a massive hole for themselves by hiding unpleasant facts about Vioxx and Celebrex. If so, Vioxx victims have a strong case now to prove that they knowingly harmed the health of hundreds of thousands of people worldwide and caused tens of thousands of deaths.

Recommended article: Vioxx recall facts must come out before attorneys bring the lawsuits to trial

Celebrex recall imminent

If you are too confused by the information during last 24 hours, here is a brief summary of what you need to know. The details are provided below:

• Celebrex, a drug prescribed as pain relief medication after the recall of Vioxx, has been found to increase the risk of heart attacks in two studies. (Related article: Celebrex found to increase risk of heart attacks)
• FDA, which has just started to review the data from the studies, is advising that your doctor should consider this evolving information in evaluating the risks and benefits of Celebrex in individual patients.
• FDA also advises evaluating alternative therapy for pain relief.
• At this time, if physicians determine that continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex.
• FDA is also saying that patients who are currently taking Celebrex and have questions or concerns about the drug should discuss them with their physicians while the agency tries to come up with the next steps. (Related article: Americans scared after Vioxx recall)

Developing story on imminent recall of Celebrex

The National Institutes of Health (NIH) announced today that it has suspended the use of COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). "Data from the report on rofecoxib (Vioxx) informed us of the need to focus on specific cardiovascular issues, and our Institutes brought in the experts to do so, said Elias A. Zerhouni, M.D., NIH Director. "Our overwhelming commitment is to advance the health and to protect the safety of participants in clinical trials. We are examining the use of these agents in all NIH-sponsored clinical studies. In addition, we are working closely with our colleagues at FDA to ensure that the public has the information they need to make informed decisions about the use of this class of drug." (Related article: Vioxx recall exposes the mess at the FDA)

"The rigor of our clinical trials system has allowed us to find this problem," said NCI Director Andrew C. von Eschenbach, M.D. "We have a strong system that provides us with the opportunity to both find ways to effectively treat and prevent disease and to do so in a way that protects the lives and safety of the participants."

After this data was provided to Pfizer, the company immediately issued a press release mentioning the findings but Pfizer says it will not pull Celebrex off the market and is studying the results closely to determine what should be done. Pfizer CEO speaking to Paul Zahn on CNN mentioned that he himself is a Celebrex patient and has no plans to change his medication. In the usual confusing language that business-people typically use in such circumstances, he said that the data is not yet conclusive enough to pull the drug off the market. He also did not want to take a position if Celebrex was a 100% safe drug for patients to take. It is, therefore, very likely that Celebrex will be recalled next week since the FDA should not allow any more American lives to be lost so that a drug company can get rich.

The FDA comments, "While we have not seen all available data on Celebrex, these findings are similar to recent results from a study of Vioxx (rofecoxib), another drug in the same class as Celebrex. Vioxx was recently voluntarily withdrawn by Merck. Another drug in this class, Bextra (valdecoxib) has shown an increased risk for cardiovascular events in patients after heart surgery. Bextra and Celebrex are the only two selective COX-2 agents currently on the U.S. market. Although these are important findings, at this point FDA has seen only the preliminary results of the studies. FDA will obtain all available data on these and other ongoing Celebrex trials as soon as possible and will determine the appropriate regulatory action."

Naturally the events leading up to how the data about Celebrex has been released has upset many. As early as two weeks ago, Pfizer was reaffirming the safety of its drugs Celebrex and Bextra. And in a press release on September 30, 2004 after the recall of Vioxx, Pfizer touted that Celebrex and Bextra were excellent alternatives to the drugs.

Consumer attorney Guerry R. Thornton is simply disgusted by the behavior of drug firms and the FDA. He thinks the system places too much emphasis on perceived benefits and not enough on the risks. "Like Vioxx, maybe the Celebrex review should have found that heart risks outweighed its benefits. The FDA relies on drug company data, and this needs to change," says Thornton.

AIDS Healthcare Foundation (AHF), the largest AIDS organization in the United States which operates free AIDS treatment clinics in the US, Africa, Central America and India, is calling upon the US government to implement an emergency ban on direct-to-consumer advertising by the pharmaceutical industry. It may be noted that the United States is only one of the two countries in the world to allow advertising of prescription drugs to consumers.

"The pharmaceutical industry continues to abuse and manipulate a fast-track drug approval process the FDA first implemented for drugs and treatments for genuine life-threatening illnesses such as AIDS in order to bring hugely profitable-and, as Celebrex and Vioxx demonstrate, increasingly deadly-drugs to market, said Michael Weinstein, AIDS Healthcare Foundation president. "While it may have been worth the risk for illnesses that are truly deadly, is it worth jeopardizing the American public's health in order to bring new, "me too" drugs that are really glorified aspirin compounds? And the drug industry then unleashes a barrage of slick, direct-to-consumer advertisements in order to convince a trusting public to buy and use these drugs that they really don't need. We are calling on the government to institute an emergency ban on such drug advertising until the process for approving, licensing and regulating our drug supply is fixed." (Related article: Vioxx recall leaves drug advertising unchanged)

"The FDA and NIH are clearly letting the American public-and the world at large-down with regard to their so-called roles as regulatory bodies overseeing the safety and efficacy of our drug supply," Weinstein went on. "The system is riddled with conflict of interest and needs to be fixed. This emergency ban on consumer adverting and creation of a new independent body to review all drug industry research would be a good first step. The issue is really one of developing a competent and respected testing and approval process that the public can truly trust and one which the world can look to."

Related article: Vioxx recall shows how FDA became toothless

Bextra and Celebrex may need to be recalled

Since the day of recall of Vioxx, the Cox-2 inhibitor drugs have come under increasing scrutiny. The other two Cox-2 drugs, Celebrex and Bextra, are manufactured by Pfizer. However, rather than revisiting the safety of Celebrex and Bextra, after Merck recalled Vioxx, Pfizer started an aggressive marketing program for the two drugs. Of course the investment paid off and most Vioxx victims switched to either Celebrex or Bextra. Bextra is used by approximately 7 million people worldwide according to The Wall Street Journal. (Related article: Cox-2 inhibitors face a bleak future)

Earlier this month, however, more disturbing data emerged about Bextra and the FDA asked Pfizer to put a stronger warning on the label and issued guidelines for physicians to be more careful in prescribing Bextra. This did not stop Pfizer from continuing its campaign to make a clear distinction between Vioxx and its drugs: Celebrex and Bextra. In fact, Pfizer's Chief Medical Officer, Joseph Feczko, even claimed that the differences exist at the molecular level and that is why the comparison is irrelevant. The company reaffirmed the safety of its drugs in remarks at an analyst conference on November 30, 2004. Or as charged by Finkelstein, Thompson & Loughran, Pfizer "misrepresented and omitted material facts concerning the safety and marketability of Pfizer's Celebrex and Bextra products." In a securities fraud class action lawsuit filed by the attorneys against Pfizer, they allege that Pfizer was aware of strong indicators that Celebrex and Bextra, drugs known as "Cox-2 Inhibitors," posed serious undisclosed health risks to consumers, that these undisclosed health risks would limit their marketability, and that the potential financial liability Pfizer faced from the harms these drugs caused posed a serious threat to the Company's finances. Nevertheless, Pfizer concealed these facts from the investing public.

On November 4, 2004, the Calgary Herald reported that "Celebrex, a popular pain drug touted as the safe alternative after Vioxx was pulled from drugstore shelves, is suspected of causing at least 14 deaths and numerous heart and brain side effects." Then, on November 10, 2004, the New York Times further shocked the market by reporting on a study finding that "[t]he incidence of heart attacks and strokes among patients given Pfizer's painkiller Bextra was more than double that of those given placebos." As a result of these and other announcements (particularly the one on December 16 that Celebrex increases the risk of heart attack), Pfizer's share price dropped from ~$30 on November 3, 2004 to $25 on December 17, 2004 (at noon). (Related article: Germany restricts prescription of Cox-2 drugs)

Wolf Haldenstein Adler Freeman & Herz LLP, another law firm that has filed a different class action lawsuit against Pfizer, allege that "This level of risk (from Celebrex) was even greater than the one found in patients taking Vioxx that led Merck to withdraw Vioxx from the marketplace." It is now believed that Pfizer may have tried to artificially inflate the market price of the Company's securities because when Joseph Feczko told analysts on November 30 that, "While other arthritis drugs can increase blood pressure, Celebrex seems not to", he was essentially trying to say something that was not true, as has been revealed in the latest statement from Pfizer.

The lawyers that are considering filing lawsuits against Pfizer for Celebrex and Bextra related injuries have support in the community of doctors. Wayne A. Ray, Ph.D., Marie R. Griffin, M.D., M.P.H., and C. Michael Stein, M.B., Ch.B., reputed doctors at the Vanderbilt University School of Medicine, write in the New England Journal of Medicine, "...We write to recommend that clinicians stop prescribing valdecoxib (Bextra) except in extraordinary circumstances. This recommendation is based on the long delay between the initial evidence of the cardiotoxicity of rofecoxib (Vioxx/Ceoxx) and its withdrawal, recent studies demonstrating the cardiotoxicity of valdecoxib (Bextra) in high-risk patients, the availability of other therapies not currently known to have cardiovascular risks, and the lack of compelling evidence of countervailing benefits. We believe this restriction should remain in effect until there are better safety data for valdecoxib (Bextra)." The doctors continue, "We believe the doubts raised about the safety of valdecoxib constitute a potential imminent hazard to public health and thus require action."

It is too early to say if Celebrex and/or Bextra will be recalled but it is becoming quite obvious that Vioxx type class action lawsuits both by those injured or killed by Celebrex/Bextra as well as shareholder lawsuits should be filed relatively quickly. Any word from FDA is still to come but it will be interesting to watch how the FDA responds since Daniel Troy at the FDA, the man-in-charge for legal affairs, last represented drug maker Pfizer, collecting up to $415,000 a year in fees. Going back to the Vioxx story, it is claimed that Merck knew as early as 2000 that Vioxx was killing people but neither the company nor the FDA did anything.

Recommended article: Why did Merck not recall Vioxx earlier?

Celebrex aggressively marketed after Vioxx recall

Every Vioxx victim remembers September 30, 2004. That was the day when Merck announced that it was recalling Vioxx. Now the way our businesses work, this was terrific news for Merck's competitors. In particular, Pfizer. Pfizer makes two competitive drugs: Celebrex and Bextra, that were struggling against the more aggressively marketed Vioxx.

Within hours of Merck's announcement to withdraw Vioxx, Pfizer jumped on the opportunity and issued a press release entitled "Pfizer Affirms Celebrex Safety" saying that over 27 million patients in the United States have been prescribed Celebrex (celecoxib), which was approved by the U.S. Food and Drug Administration in 1998.

"Pfizer is confident in the long-term cardiovascular safety of Celebrex," said Dr. Joe Feczko, Pfizer's president of worldwide development. In fact Pfizer went further and added, "In a recent FDA-sponsored study of 1.4 million patients, those who received Celebrex demonstrated no increased risk of cardiac events."

"Patients taking COX-2 inhibitors may be confused and should speak with their doctors," Dr. Feczko said. "Because of its outstanding long-term safety profile and broad indication base including osteoarthritis, rheumatoid arthritis and acute pain, Celebrex is an appropriate treatment alternative." (Related article: One study found that Celebrex was less dangerous than Vioxx but it did not prove that Celebrex was safe)

Pfizer's aggressive marketing helped the company. In October, the first full month of data after the recall of Vioxx, sales of Celebrex topped $260 million, or 63.5 percent of the market for cox-2 inhibitors, according to IMS Health data. In September, Celebrex had accounted for just 48.7 percent of the market for the new-generation painkillers. Bextra sales in October totaled $148 million or 36 percent of the $409 million cox-2 inhibitor market. In September, Bextra had just 23.5 percent of that market.

Pfizer commented that Celebrex was the first COX-2 inhibitor, a class of medicine designed to relieve pain without the serious gastrointestinal side effects associated with older non-steroidal anti-inflammatory medicines. In 2001, Pfizer introduced Bextra (valdecoxib), its second COX-2 inhibitor, for use in osteoarthritis and rheumatoid arthritis. Bextra’s cardiovascular safety profile is also well established in long-term studies, Pfizer added.

Pfizer claimed that data show that since the introduction of COX-2 inhibitors, the rate of hospitalizations for gastrointestinal events associated with long-term arthritis treatment has declined significantly.

It is important to point out that there is no definite talk to recall Celebrex since the data is still being analyzed.

Recommended article: Limelight focused on Vioxx, Celebrex, and Bextra (all Cox-2 drugs)

Vioxx alternative Celebrex also increases heart risks

Pfizer Inc is announcing that it has received new information about the cardiovascular safety of its COX-2 inhibitor Celebrex (celecoxib), an alternative drug to Vioxx, based on an analysis of two long-term cancer trials. It is important to note that the other common Vioxx alternative, Bextra, already carries a very strong warning. There is still disagreement among scientists in the United States about the safety of Vioxx-type drugs (they all belong to the family of drugs known by the technical name Cox-2 inhibitors), but the German authorities are so concerned about the safety of Cox-2 drugs that they have severely restricted prescription of these drugs while European authorities conduct a more through review. Both Celebrex and Bextra have captured the market share since the recall of Vioxx.

As reported to Pfizer by the Data Safety and Monitoring Board, one of the studies (the APC cancer trial) demonstrated an increased cardiovascular risk over placebo, while the other trial (the PreSAP cancer trial) revealed no greater cardiovascular risk than placebo. (Related article: Alternatives to Vioxx are not totally safe)

“These clinical trial results are new. The cardiovascular findings in one of the studies (APC) are unexpected and not consistent with the reported findings in the second study (PreSAP). Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians and patients around the world,” said Hank McKinnell, Pfizer chairman and chief executive officer. There is no comment yet (as of 11 AM Eastern on December 17, 2004) from the FDA. It is also important to note that Pfizer has been somewhat more forthcoming about the adverse side effects of Celebrex and Bextra, in total contrast to Merck, that engaged in an organized campaign to hide the facts from the world. (Related article: Why did Merck not recall Vioxx earlier?)

Celebrex is approved for use in the United States for the treatment of arthritis and pain, at recommended doses of 100mg to 200mg daily for osteoarthritis and 200mg to 400mg a day for rheumatoid arthritis. It is also approved for a rare condition called familial adenomatous polyposis in doses up to 800mg per day. The APC cancer trial studied Celebrex at doses of 400mg to 800mg per day. In the PreSAP cancer trial the dose was 400mg per day.

“In placing this new information in context, it is important to understand that the APC trial results differ from both the PreSAP cardiovascular results as well as the large body of data that we and others have accumulated over time, in which an increased risk of serious cardiovascular events in arthritis patients, even at higher-than-recommended doses, had not been seen,” said Dr. Joseph Feczko, president of worldwide development for Pfizer.

“Celebrex is an important medicine that provides necessary pain relief to many patients. Patients being treated with Celebrex should discuss appropriate treatment options with their healthcare professionals. Physicians should factor this new information, as well as ulcer risks and gastrointestinal bleeding seen with traditional NSAIDs, into their prescribing decision.”

In the Adenoma Prevention with Celecoxib (APC) trial, patients taking 400mg and 800mg of Celebrex daily had an approximately 2.5 fold increase in their risk of experiencing a major fatal or non-fatal cardiovascular event compared to those patients taking placebo, according to the National Cancer Institute (NCI). Based on these statistically significant findings, the sponsor of the trial, the NCI, has suspended the dosing of Celebrex in the study. (Related article: Vioxx more dangerous than Celebrex)

In a separate long-term study, the Prevention of Spontaneous Adenomatopus Polyps (PreSAP) trial, there has been no increased risk for Celebrex patients taking 400mg daily compared with those taking placebo. These findings are based on an identical analysis used to assess cardiovascular risk in the APC trial and conducted by the same independent safety review board. The information from this Pfizer sponsored trial was also received by Pfizer last night and, as with the APC information, was immediately shared by the company with the U.S. Food and Drug Administration.

The two studies, which are following patients over a five-year period, have enrolled a total of about 3,600 patients, some of whom have participated for more than four years. Pfizer estimates that about 2,400 patients evaluated in the cardiovascular analysis have completed two years of treatment.

A third long-term study involving Celebrex in patients at high-risk for Alzheimer’s disease is also under way with about 2,000 patients enrolled, about 750 of whom are on 400mg per day of Celebrex. As with the cancer studies, this study is monitored by independent safety experts who meet regularly to assess adverse events. A review by this board as recent as December 10 did not result in any recommendations to change the conduct of this study.

In September and October, the Data Safety and Monitoring Boards of the APC and PreSAP cancer trials conducted a preliminary review of all the then-available data and determined to proceed with the studies. With the cooperation of Pfizer, the safety review boards convened a panel of cardiovascular experts to conduct additional reviews and analyses of the data from these two trials. Last evening, Pfizer received preliminary information resulting from the reviews. The company has not yet received the full analyses of these studies.

As previously announced, Pfizer will continue to work with FDA on the company’s plans to sponsor a major clinical study to further assess Celebrex in osteoarthritis patients at high-risk for cardiovascular disease. (Related article: Alternatives to Vioxx and Celebrex for pain relief)

Patients who have aspirin-sensitive asthma, or allergic reactions to aspirin or other arthritis medicines or certain sulfa drugs called sulfonamides, or who are in their third trimester of pregnancy should not take Celebrex. As with all NSAIDs, serious gastrointestinal tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding. Celebrex does not affect platelet function and therefore should not be used for cardiovascular prophylaxis. As with all NSAIDs, Celebrex should be used with caution in patients with fluid retention, hypertension, or heart failure. In overall clinical studies the most common side effects of Celebrex were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate.

Recommended article: Cox-2 inhibitor drugs face a bleak future

Source: Pfizer

Vioxx recall exposes the mess at FDA

Since the recall of Vioxx by Merck in late September, no one has come forward yet to take responsibility for the deaths of tens of thousands of Americans and injuries to many more. While Merck has taken a highly antagonistic approach and has started a coordinated program of attack against Vioxx victims, FDA has either defended its role or sided with Merck's position. Adding to the misery of Vioxx victims, the White House announced yesterday that they want to completely rewrite the laws of the United States so that victims of Vioxx (or for that matter any other product that kills of injures Americans) will lose their legal rights to file class action lawsuits or to demand any compensation from companies. Not surprisingly enough, the legislation is strongly supported and being pushed by businesses.

When Dr. David Graham, an expert at the FDA, exposed during hearings at Congress (what was already well known among American scientists) that the FDA was an agency in a mess, that there were four other Vioxx like drugs on the market that Americans take without thinking about their side effects, and that the agency was incapable of ensuring the safety of drugs sold in the United States, he was strongly criticized by his colleagues at the FDA, who started a coordinated campaign to discredit. Dr. Graham is fighting to keep his job and would have lost it already without the interference of Senator Chuck Grassley and others in Congress.

But it looks as if Dr. David Graham was essentially lending a voice to his colleagues at the FDA. In a previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released by the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER). The FDA survey results, obtained under the Freedom of Information Act, closely track the safety concerns raised by the agency’s own Associate Director for Science and Medicine, Dr. David Graham, in testimony before the U.S. Senate last month. (Related article: Vioxx recall mess shows that fundamental changes may be needed at the FDA)

The Health and Human Services Office of Inspector General conducted the survey in late 2002 as part of a management review of how the agency was meeting stringent deadlines for approving new drugs. OIG polled 846 FDA scientists, with nearly half (47%) completing the survey. Survey findings included:

• Two-thirds (66%) of respondents lacked confidence that the agency “adequately monitors the safety of prescription drugs once they are on the market;”
• Only 12% of scientists were completely confident that FDA “labeling decisions adequately address key safety concerns” while 30% were not at all or only somewhat confident;
• More than one third (36%) of scientists were not at all or only somewhat confident that “final decisions adequately assess the safety of a drug”; and
• Nearly one in five scientists (18%) said that they “have been pressured to approve or recommend approval” for a drug “despite reservations about the safety, efficacy or quality of the drug.”

Despite the disquieting survey results, when the OIG published its report in March 2003, a lead conclusion was that FDA scientific reviewers “have high confidence in decisions FDA makes.”
“The survey raises significant issues about drug safety and ongoing monitoring of adverse health impacts of drugs in the marketplace,” stated Kathleen Rest, executive director of UCS. “The scientists concerns warrant further investigation as Congress reviews drug approval practices at FDA.” (Related article: How did Vioxx become toothless?)

The fact that Dr. Graham’s supervisors have publicly disparaged his testimony highlights a weakness in FDA’s ability to dispassionately resolve scientific differences. In the survey of scientists, less than one in five (17%) felt the agency had “adequate procedures in place to address scientific disagreements” to a “great extent,” while 45% felt adequate procedures existed only to “some extent” and more than a third (38%) said procedures for resolving dissent existed only to a “small extent” or “not at all.”

“By all appearances, FDA would rather be sorry than safe,” stated PEER Program Director Rebecca Roose who obtained the survey under the Freedom of Information Act. “These results show that many of Dr. Graham’s colleagues share his concerns, but that those warnings are falling on deaf ears.”

Recommended article: FDA is a lapdog of the drug industry

Vioxx attorneys soothe nerves of victims

Several readers have written to us asking for our recommendations on what to do next after a series of setbacks this week. Of course, the headlines this week have been devastating for Vioxx victims and those that have lost loved ones due to Vioxx. First, Merck started with an all-out attack on Vioxx victims. Apparently, the aggressive stance was adopted to send a strong message to Vioxx attorneys that they should not expect a cakewalk in Vioxx lawsuits.

The message was also directed at Wall Street analysts to demonstrate that Merck was in control and since it had made no provisions for the expected $38 billion Vioxx liabilities (some analysts now estimate that this number could be as high as $55 billion), the reason was that it would prevail in the lawsuits and would not have to pay anything. And it looks as if some clueless Wall Street analysts are buying into rosy picture presented by Raymond Gilmartin who is slowly taking Merck on a path of destruction. But maybe not, if President Bush has his way. The news that is coming out of the White House is that the United States may soon take away the rights of Americans to sue corporations when they kill or injure. Apparently the program is being positioned as a way to create jobs in the country.

But Vioxx attorneys are not discouraged. In their opinion, the aggressive stance taken by Merck is part of a PR campaign to discourage Vioxx victims. By sending a message that the fight will be tough and Merck can drag the cases through the courts for years/decades, Merck wants to discourage the poor and the elderly from coming forward and claim compensation. Merck's desperate attempts are understandable. (Related article: Americans scared after Vioxx recall)

According to Scott + Scott, LLC, a Connecticut-based law firm, "The deteriorating outlook of Merck is based in large part on Merck's difficulties over Vioxx. The Vioxx withdrawal has weighed heavily on the company, causing it to lose its AAA credit rating and prompting criminal and civil investigations, lawsuits, legal liability and congressional hearings."

Next steps for Vioxx victims

1. Stop getting intimidated by either Merck or the Federal Government.
2. Act fast. If you think you have been injured by Vioxx or have lost a loved one, work with a good Vioxx attorney. Here are tips on how to find a good Vioxx attorney and how to protect yourself from Vioxx scams.
3. Be careful which law firm you work with. During last two weeks there has been a proliferation of websites that make unreasonable claims. Read tips to how to protect yourself from fraud related to Vioxx. These websites are typically found in a search. It is best to work with a law firm that advertises (that way you know it is the law firm itself and not some crook) and has a website that clearly lists who the Vioxx lawyers are, where do they work, how to contact them in person or by phone, and how will they work for you. Many other websites are simply trying to collect your information to sell it to telemarketers and junk mailers for possible fraud.
4. If in doubt, you can contact us. We are an independent source of information on Vioxx and have no affiliation with any Vioxx lawyer.

Recommended article: Should you accept cash advance from a Vioxx attorney?

Vioxx victims right to be taken away soon

If you have been surprised by the ferocity with which Merck has been attacking Vioxx victims, there is no need to. Merck appears more confident than ever that it will prevail in the Vioxx litigation and it does not have to apologize for Vioxx related deaths and injuries. As everyone knows, the FDA has been the best friend for Merck. From day one, FDA, which should control the drug industry, has actually come to the rescue of Merck. Now the White House is openly supporting the position taken by Merck. It may be pointed out that the Merck CEO Raymond Gilmartin (along with many others at Merck and in the pharmaceutical industry in general) has contributed enormous sums of money for President Bush and many others in Republican Party, all of whom hold important positions in the administration.

A panel discussion that was held as part of the economic summit showed where the focus is - to take away the right of American people to file a lawsuit if a loved one gets killed by a faulty product or if someone is injured. Once this legislation is passed, Americans will literally have their rights taken away so that big corporations can do business profitably even if their products kill Americans. (Related article: Merck critic may lose his job at FDA)

The Center for Responsive Politics, a non-partisan group that tracks campaign spenders, found that conference participants at the White House donated nearly $195,000 to various Republican candidates or causes in recent years, including $40,000 to Bush. All participants were business owners or chief executives (for instance, Robert Nardelli, the CEO of Home Depot and a supporter of President Bush mounted a harsh attack on Americans who have been hurt by a company and try to receive compensation) and support President Bush. No consumer rights groups or lawyers were invited to the panel.

The President, who thinks that Americans hurt by a faulty product think of asking for compensation for their pain and suffering as a lottery, said, "...this is a priority issue for not only me, but for a lot of people in the Senate. I say the Senate -- it will pass the House. It is being blocked by a few in the United States Senate, and the trial bar has made this the number one issue for them. But it's, as I think you mentioned, Hilda, the notion of a lottery -- we cannot have the legal system to be a legal lottery....I intend to take a legislative package to Congress which says we expect the House and the Senate to pass meaningful liability reform on asbestos, on class action and medical liability." He was referring to passing of Class Action Reform Act that will make it almost impossible for Vioxx class action lawsuits to go forward. No wonder Merck seems so confident that it has not made provision for even one dollar for Vioxx litigation in its financial projections. (Related article: Merck continues its attack on Vioxx victims to shore up its stock price)

Medical errors kill as many as 98,000 Americans every year and cost as much as $29 billion, according to the Institute of Medicine. Other research suggests that the human toll may be far higher, with preventable errors and negligence taking the lives of 195,000 people each year. While exact estimates are not known but tens of thousands of Americans are presumed to have died due to Vioxx alone. (Related article: Vioxx death toll higher than Iraq war and 9/11)

"He 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," says Todd A. Smith President, Association of Trial Lawyers of America. He continues, "Give us a break, Mr. President. Giving your friends in the insurance, drug, tobacco, chemical and other industries another windfall at the expense of American families is not an economic recovery plan." The Center for Justice & Democracy responded, "President Bush should stop putting corporate profits and special interests before the lives of average Americans, who will die under his proposals."

Recommended article: How to find a good Vioxx attorney?

Merck's attack on Vioxx victims helps its stock price

So for one full day, Merck essentially worked very hard to convince the world that it is right and everyone else is wrong, particularly all those who expect compensation from Vioxx related lawsuits. If anyone died or was seriously injured, it was not Merck's fault. They were doing something else wrong to kill themselves or attract all kinds of other side effects.

And while Vioxx attorneys digest Merck's attack strategy and develop their own game plan, it looks like the analysts at Wall Street are getting excited by what Merck had to say: Merck will get rid of over 5,000 employees, it will keep the R&D level unchanged (which in the drug industry means that you are cutting back significantly), and embark on a plan to keep its costs under control.

Michael Krensavage of Raymond James & Associates is taking a contrarian approach and has raised his rating on the company to "strong buy" from "market perform". Or in other words, what Krensavage is saying is that after all that the company did, Merck is still the greatest company on the planet. "While the price of Vioxx woes are impossible to predict, Merck is unlikely to make a significant voluntary settlement for years," Krensavage wrote in a research note to his high-net worth clients. He added that even if Merck loses, it will have years of appeal and will make it harder for any Vioxx victims to collect anything. At this time, Krensavage is alone in being so bullish on the company. Other analysts see only ugly days ahead for the firm, particularly as news starts to filter in from overseas that Vioxx victims are filing lawsuits against Merck.

Another news that is catching the attention of the sympathizers of Vioxx victims is the medical malpractice legislation that President Bush advocated at today’s Economic Summit. The plan is designed to help companies like Merck at the expense of American people. The Center for Justice & Democracy, a non-partisan, public interest organization says, "This legislation would take away legal protections that have saved thousands of lives. These laws have protected us from dangerous and defective drugs and medical devices like Vioxx, the Dalkon Shield and Copper-7 IUDs, an antibiotic that caused cancer, oral contraceptives that caused life-threatening injuries, a pregnancy test that led to false-positives for cancer, and many others. Without these laws in place, drugs like Vioxx would still be sold and people would be hurt or killed. The Administration’s plan will result in Americans dying so that the drug companies can make even more money." A statement released by the group calls upon President Bush to stop putting corporate profits and special interests before the lives of average Americans, who will die under his proposals.

Recommended articles: FDA sides with Merck in Vioxx recall scandal and Vioxx recall and Washington politicians

Merck continues its attack on Vioxx victims

Merck relentlessly continued its ongoing attack on Vioxx victims. In a series of statements released yesterday by the firm, Merck is treating Vioxx victims as if they are the ones who have done something wrong. Forget about even a word of apology for the deaths and injuries or even a mention of the pain caused to those who consumed its product. On the other hand, the management team of Merck went on an all-out attack against Vioxx lawyers and victims and proclaimed that it was ready to fight anyone who ends up in court with a Vioxx lawsuit.

So when the Merck CEO says, "The only things we haven't changed are our commitments to patient safety, to the highest ethical standards, and to excellence and integrity in our science," it sounds so hollow. We wonder which patient taking Merck medicines would believe this statement when the company continues to treat patients who took Vioxx as criminals. (Related article: Vioxx class action lawsuits against Merck exploding)

Below are excerpts from the statement made by CEO Raymond Gilmartin in presentation to analysts and investors:

"On the afternoon of Sept. 24, Dr. Peter Kim, President of Merck Research Laboratories, called to alert me to information he had received just that morning. The information was from an independent, external board of physicians and scientists monitoring the safety of patients in a major trial on VIOXX. He told me that in the trial we sponsored – known as APPROVe – there was an increased risk of confirmed cardiovascular events beginning after 18 months of continuous daily treatment in patients taking VIOXX compared to those taking placebo.

That call triggered a series of events that led, within four days of that call, to Merck contacting the FDA to tell them that we were going to voluntarily withdraw VIOXX from the market. The decision that we made to withdraw VIOXX was difficult in several ways. VIOXX was the only nonsteroidal anti-inflammatory medicine or NSAID that was demonstrated to provide pain relief similar to high-dose NSAIDs and proven to reduce the risk of developing debilitating gastrointestinal side effects compared to those on NSAIDs. This was an important benefit for many who suffered from the pain of arthritis and other conditions. An estimated 15,000 Americans die each year from gastrointestinal bleeding associated with NSAID use.

Many patients counted on VIOXX to help them when no other medicine would. We believed that it would have been possible for Merck to continue to market VIOXX with labeling that would incorporate the new data. (Related article: Vioxx most dangerous drug in Cox-2 inhibitors drug category)

On another level, however, the decision we made to withdraw VIOXX was easy. Given the availability of alternative therapies and the questions raised by the data, withdrawing VIOXX was consistent with an ethic that has driven Merck actions and decisions for more than one hundred years. Merck puts patients first. (Related article: Why Merck did not recall Vioxx earlier?)

I would like to make three points clear at the outset.

1. First, the Food and Drug Administration approved VIOXX only after Merck had extensively studied the medicine and found it to be safe and effective. Merck continued to extensively study VIOXX after it was approved for marketing to gain more clinical information about the medicine. (Related article: Vioxx approval may have been a mistake by the FDA)
2. Second, since the time Merck submitted a New Drug Application for VIOXX to the FDA, we have promptly disclosed the results of numerous Merck-sponsored studies, including the VIGOR study, to the FDA, physicians, the scientific community and the media and participated in a balanced, scientific discussion of its risks and benefits. (Related article: Merck mounted an attack on all studies that showed that Vioxx was a problem drug)
3. Third, until APPROVe, the combined data from randomized controlled clinical trials showed no difference in confirmed cardiovascular event rates between VIOXX and placebo and VIOXX and NSAIDs other than naproxen. And we only found an increased risk of cardiovascular events in APPROVe because Merck continued to study VIOXX for such a long time period. When data from the APPROVe study became available, Merck acted quickly to voluntarily withdraw the medicine from the market.

We are confident that a careful and complete examination of Merck's conduct shows that, at all times, we acted responsibly and in a manner consistent with Merck's commitment to patient safety and our rigorous adherence to scientific investigation, openness and integrity. Throughout Merck's history, it has been our rigorous adherence to scientific investigation, openness and integrity that has enabled us to bring new medicines to people who need them. I am proud that we followed that same rigorous scientific process at every step of the way with VIOXX."

Recommended article: Vioxx recall is a classic example of risk management by Merck

Cox-2 inhibitor drugs face a bleak future

With the recent recall of Vioxx, a critical challenge facing the Cox-2 inhibitor markets in the United States is the need to conclusively demonstrate the safety of these drugs in long-term use. New analysis from Frost & Sullivan reveals that this market generated revenue of $3.6 billion in 2004. Total market revenues are expected to decrease to $3.13 billion in 2010. It may be pointed out that the German authorities have already issued guidelines restricting prescription of all Cox-2 inhibitors drugs till more data is available. In the United States, however, there is no restriction yet on Cox-2 as a whole, but Bextra, a Cox-2 drug, carries a much stronger warning due to its adverse side effects.

Vioxx was voluntarily recalled after data from a clinical trial revealed that it increased patients' risks of getting heart attacks and strokes. Proving the safety of other Cox-2 inhibitors in long-term use is, therefore, likely to be a difficult task. "Post recall, gaining the approval of the Food and Drug Administration (FDA) for new Cox-2 inhibitors is likely to be a long-drawn out process," says Frost & Sullivan Research Analyst Elisa Perez. "The FDA may even require additional information that will prolong the return on investment (ROI) for these products." (Related article: Americans scared after Vioxx recall)

Extensive clinical trials are necessary to demonstrate the safety of using Cox-2 inhibitors over a prolonged period of time. While these trials will involve additional expenses, they are essential if companies hope to gain the required FDA approval and successfully penetrate the market.

The market also faces the challenge of getting physicians and patients to accept these drugs for use as pain management therapies. "Physicians' reluctance to prescribe Cox-2 inhibitors for pain therapy is increasing," remarks Perez. "A growing amount of data - suggesting that other Cox-2 inhibitors may also carry the risk of cardiovascular adverse effects - is likely to further hurt this market as physicians and patients look to over-the-counter (OTC) products or traditional non-steroidal anti-inflammatory drugs (NSAIDs) for pain management." (Related article: Vioxx alternatives may not be totally safe)

Removing the stigma associated with the adverse side effects of Vioxx, and potentially other Cox-2 inhibitors as well, will require companies to adopt aggressive marketing strategies targeted at physicians as well as patients. Physician education will help in increasing their prescriptions of these therapies, which in turn will make patients more amenable to using them.
"With the recall of Vioxx having impacted not only the Cox-2 inhibitor markets, but also the pharmaceuticals industry as a whole (Related article: Fundamental changes are needed in drug approval process), patient and physician education is critical," remarks Perez. "Pharmaceutical companies should work closely with the FDA to determine the best strategy in the event of recall of a drug. Clinical trials to ensure long-term efficacy and safety are very important for the success of a drug."

Recommended article: Vioxx recall focuses limelight on Cox-2 inhibitors

Source: Frost & Sullivan

Merck provides useful Vioxx related data

In Merck's chitchat with Wall Street analysts and investors today, a lot of interesting details came out, in particular how aggressively the company plans to fight its customers who spent their hard-earned money to take Vioxx but many of them actually died or were seriously hurt. (Related article: Merck vows to fight Vioxx class action lawsuits vigorously)

1. When asked during the call if Merck had estimated the cost of Vioxx related litigation, the company would not comment, telling analysts that they have to view the claims "with a critical eye." Robert Steyer is reporting that analysts' estimates on Vioxx's liability have gone as high as $55 billion, although many analysts have kept their estimates under $20 billion. (Related article: Sanford Bernstein estimates Merck's Vioxx liabilities to be $38 billion)
2. Merck also informed that the first personal injury trial should begin during the first half of 2005 in Texas or Alabama.
3. There are all kinds of estimates being floated around regarding the number of people who have taken Vioxx in the US and worldwide. Merck now estimates that 105 million U.S. prescriptions were written for Vioxx between May 1999 and August 2004. The company says approximately 20 million people in the U.S. used the drug. The number of foreign patients is unknown. Frazier said Merck has "no reliable estimate" on how many used Vioxx for prolonged periods of time.

Recommended article: How to pick a good Vioxx attorney?

Merck vows to fight Vioxx class action lawsuits vigorously

As the firm has been saying since the recall of Vioxx, Merck reiterated today that it will fight very vigorously any class action lawsuits filed against the company. Several Merck executives including the CEO and general counsel were speaking to analysts and investors in a day full of presentations and conference calls.

Here are key points from Merck's announcements and the text of Merck's statement related to Vioxx is below:

1. Merck will fight every single lawsuit in the Vioxx recall case. So if you have been planning on getting rich by suing Merck, the company is telling you, "Forget it!". (Related article: How to protect yourself from Vioxx scams and fraud?)
2. It does not plan to settle the cases out of court.
3. Merck believes that there is no basis for class action status since there is no commonality in the cases. (Related article: How to avoid gold-digger Vioxx attorneys?)
4. Merck is admitting no wrongdoing and is essentially repeating that it withdrew Vioxx as soon as it came to know of Vioxx related deaths and other injuries.
5. Merck has not made any provisions for Vioxx related liabilities that may reach as much as $38 billion. (Related article: Should you accept Vioxx lawsuit related cash advances?)
6. The company admits, though, that in the worst case scenario, it will be basically go out of business.

Merck's statement on Vioxx litigation

In his presentation today on VIOXX litigation, Merck Senior Vice President and General Counsel Kenneth C. Frazier stated that the company will vigorously defend against VIOXX-related lawsuits, including taking cases to trial. He also said Merck will oppose any efforts to seek class-action treatment with respect to the personal injury lawsuits because there is no commonality to the cases. "Merck voluntarily withdrew VIOXX from the marketplace and believes the company has acted appropriately at all times," Mr. Frazier stated.

VIOXX Litigation Update

As previously disclosed, 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 Nov. 30, the company has been served or is aware that it has been named as a defendant in approximately 475 lawsuits, which include approximately 1,100 plaintiff groups alleging personal injuries resulting from the use of VIOXX. Certain of these lawsuits include allegations regarding gastrointestinal bleeding, cardiovascular events and kidney damage. The company has also been named as a defendant in several putative class actions seeking medical monitoring as a result of the putative class members' use of VIOXX. In addition, certain state court actions seek various remedies under state consumer fraud and fair business practice statutes, including recovering the cost of VIOXX purchased by individuals and third-party payers such as union health plans (all of the actions discussed in this paragraph are collectively referred to as the "VIOXX Personal Injury 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 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 Personal Injury Lawsuits pending in federal court have made similar requests.

In addition to the VIOXX Personal Injury 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. 9, 12 VIOXX Securities Lawsuits have been filed. In addition to the VIOXX Securities Lawsuits, shareholders have brought derivative lawsuits against the company. As of Dec. 9, six such lawsuits have been filed. Also, lawsuits asserting claims under the Employee Retirement Income Security Act have been brought against the company. As of Dec. 9, 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.

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.

The company currently anticipates that one or more of the VIOXX Personal Injury 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 not established any reserves for any potential liability relating to the VIOXX Lawsuits. A series of highly unfavorable outcomes could have a material adverse effect on the company's financial position, liquidity and results of operations.

Recommended article: Merck continues to defend its Vioxx recall strategy

Vioxx recall and lawsuits hurt Merck

In its annual business briefing to analysts and investors, Merck has made two key announcements in the wake of recall of Vioxx and filing of lawsuits against the company by those injured by Vioxx: (Related article: Number of class action lawsuits in the Vioxx case growing rapidly)

1. Merck will cut about 5,100 jobs by year's end, more than originally planned and this will save $300 million on payrolls next year.
2. The company also expects its spending on research and development (R&D) next year to be at the same level as this year

What does Merck's announcement mean?

Merck is essentially preparing to meet its liabilities from recall of Vioxx that are estimated to be as high as $38 billion. While the company has been talking about reassigning its Vioxx staff, it will need to get rid of many of them as its drug pipeline is not as impressive as it should be, particularly with the expiration of Zocor patent.

Keeping the R&D budget at the same level is another indication that Merck will no longer be a powerful player in the pharma sector, which is driven by innovation. Merck has always ranked high on the Innovation Index published by the MIT Technology Review magazine but it is now obvious that its rank will go down.

Merck's stock price has continued to drop since the recall of Vioxx. From a price of around $45, the stock is currently trading at ~$30 as investors lose confidence in the firm and worry that Vioxx lawsuits will sink the company. It will be interesting to see how many more investors will abandon the stock.

Recommended article: Vioxx recall calls for management changes at Merck

Safety of Bextra questioned by Senate

Many people who have been injured by Vioxx have had to find alternatives to the drug since the recall of Vioxx in late September. The two drugs that doctors have rushed to prescribe are Celebrex and Bextra, both of which belong to the Cox-2 category. There is conflicting data at this time if these two drugs are safe, though there is evidence that Vioxx was the most dangerous of them all. The German authorities are so concerned about the safety of Cox-2 drug that they have severely limited how these drugs are prescribed.

In the United States, however, Celebrex is being marketed without any warning at all (many Vioxx victims that have written to us do not fully understand what is meant by Cox-2 inhibitor drugs) while Bextra now carries a much stronger warning about its adverse side effects.

Sen. Chuck Grassley, Chairman of the Senate Finance Committee, is now asking the Food and Drug Administration to explain how it has evaluated the risks associated with the painkiller Bextra and made decisions about the agency's regulatory response. Grassley's request for information follows the announcement by Pfizer that doctors will be warned about Bextra's cardiovascular risk and be given stronger cautions about the drug's possible effect on the skin. (Related article: Changes needed in drug approval process after Vioxx scandal)

The lead witness, Dr. David J. Graham, at an oversight hearing held in November by Grassley warned of problems with Bextra and four other drugs on the market today, about which Grassley said he will also ask the FDA for information. The panel examined the actions of the Food and Drug Administration before Vioxx was pulled from the world market in September by Merck. The senator said today that his letter to the acting administrator of the Food and Drug Administration is part of what will be a sustained effort to restore greater public confidence in the federal government's food and drug safety agency. "When the FDA approves a drug, you should be able to bank on it," he said. "If a drug isn't safe, you should know the FDA will take it off the market." (Related article: Vioxx critic may lose his job for criticizing FDA)

In addition to questioning the Food and Drug Administration about Bextra, Grassley said he will ask Bextra's maker, Pfizer Inc. for information about its decision to make the labeling changes and its communication with the FDA about the drug's cardiovascular risks. In conjunction with his oversight work, Grassley is pressing for reforms – both legislative and administrative – to bring about greater responsiveness and transparency at the Food and Drug Administration. The senator said he will introduce legislation early next year to establish an independent office of drug safety in the Food and Drug Administration. "The office that reviews the safety of drugs that are already on the market should not in any way be under the thumb of the office that put the drugs on the market in the first place, which is what we have today as a practical matter." Grassley said he is also looking at legislation to establish a clinical trial registry for drug companies to make more information available to the public regarding pharmaceutical drugs on the market. (Related article: Vioxx scandal shows how FDA became toothless)

In a letter to Lester M. Crawford, Acting Commissioner of the FDA, Grassley is asking very tough questions and is directing the FDA to send complete set of documents related to Bextra so that the Senator's office can review if the FDA has taken all the steps necessary to secure the safety of the drug. He has also asked about other drugs with serious safety problems: Meridia, Crestor, Accutane, Bextra and Serevent. These drugs are being taken by Americans with no warning at all at this time though Dr. Graham had testified before the Committee that they were potentially as dangerous as Vioxx.

Recommended article: FDA taken to task for Vioxx recall handling

Vioxx type drug use limited in Germany

The Drug Commission of the German Medical Association (the equivalent of the Food & Drug Administration or FDA in the United States) is limiting the prescription of all drugs in the Cox-2 category. It may be noted that Vioxx is a Cox-2 inhibitor and it was recently recalled by Merck. Two other drugs Celebrex and Bextra that are gradually taking up the market share of Vioxx are also from the same Cox-2 category. There is no consensus among scientists in the United States if all drugs in the Cox-2 category are as dangerous as Vioxx though one study has shown that Vioxx was the most dangerous of all. (Related article: Vioxx recall focuses limelight on Cox-2 inhibitor drugs)

At this time, Celebrex is emerging as the most popular alternative to Vioxx and Bextra has been prescribed to some arthritis patients though it is expected that its share will go down as new safety warnings are added to Bextra. (Related article: Warning issued on Vioxx alternative Bextra)

According to German authorities, Cardiovascular complications are a side effect of all Cox-2 drugs. After the recall of Vioxx, they are questioning the safety of the remaining four drugs on the market: Celecoxib (Celebrex®); Valdecoxib (Bextra®), Parecoxib (Dynastat®) and Etoricoxib (Arcoxia®). The European drug approval authority is expected to deal with this question in the coming months.

The German Medical Association is recommending that doctors in Germany be very careful in prescribing Cox-2 drugs and prescribe it to only those patients that are likely to receive the most benefit and have the least susceptibility to cardiovascular complications:

• Cox-2 drugs are not to be given to all cardiovascular risk patients.
• Cox-2 drugs are to be used with patients over 65 years only during strict supervision by the doctor and with special precaution because the cardiovascular risks generally increase at the age.
• The use of all Cox-2 drugs in general is to be limited till more data is available. The suggested time is only 3 months.

Recommended article: Alternatives to Vioxx are not totally safe

Another Vioxx type scandal with AIDS drug

John Solomon of Associated Press has published a horrifying report that the United States was sending drugs for AIDS patients to Africa when it knew that the drug was flawed and potentially lethal. This is very similar to the approach the FDA and Merck took with Vioxx (also sold as Ceoxx in some countries). Both the FDA and the drug manufacturer seem to have hidden facts related to Vioxx and the drug was withdrawn only after tens of thousands are either dead or seriously injured. (Related article: Vioxx recall scandal calls for fundamental changes in drug approval process)

Nevirapine, an AIDS drug (pronounced Nee-VERA-peen), is made by Boehringer Ingelheim Corp. and is marketed under the brand name Viramune. There are two generic versions, Nevimune, made by Cipla, and Nevirex, made by Aurobindo Pharma. The drug has also been used in the US since the 1990s to treat adult AIDS patients and is known to have potentially lethal effects like liver damage and severe rashes when taken over time.

According to documents obtained by The Associated Press, the National Institutes of Health in the United States, the government's premier health research agency, chose not to inform the White House as it scrambled to keep its experts' concerns from scuttling the use of nevirapine in Africa as a cheap solution. The data, from a flawed study in Uganda, raise significant safety questions about a relatively easy and inexpensive way to prevent mother-to-child (MTC) transmission of the HIV. The regimen has been widely used in the developing world to prevent HIV infections in newborns.

The AIDS Healthcare Foundation (AHF), the largest AIDS organization in the United States which operates free AIDS treatment clinics in the US, Africa, Central America and India, is calling upon the US government to create a new, independent blue ribbon commission or panel to review all drug research.

"The FDA and NIH are clearly letting the American public -- and the world at large -- down with regard to their so-called roles as regulatory bodies overseeing the safety and efficacy of our drug supply," said Michael Weinstein, AIDS Healthcare Foundation president. "From Vioxx to the flu vaccine, we've recently seen the deadly consequences of not having truly independent voices in the approval, licensing and regulation of our nation's drugs. The system is riddled with conflict of interest and needs to be fixed. The creation of a new independent body to review all drug industry research would be a good first step."

"More than 90 percent of researchers and scientists working at the NIH also receive some form of drug industry money," added AHF's Weinstein. "The fox really is watching the henhouse, and as a result, the credibility of these agencies is shot and the public's trust has been squandered."

"With regard to MTC transmission and nevirapine, we believe the best course is to treat the entire family unit, mother and child," said Dr. Charles Farthing, AHF's Chief of Medicine. "There are ethical issues that arise if one tries to prevent HIV infection in a newborn, yet lets the mother go untreated and die. Who then cares for this HIV-negative child?"

"We also have grave concerns about the possibility that people in resource-poor countries around the world may be participating in studies and research treatments that the drug companies might not undertake here in the US and that should cease," added AHF's Weinstein. "However, more and more people in Africa and the developing world are living now because they are beginning to have access to such life-saving AIDS drugs, and these setbacks with the FDA and NIH should be no excuse to slow the process of rolling out proven treatments. The issue is really one of developing a competent and respected testing and approval process that the public can truly trust and one which the world can look to."

Viramune® (nevirapine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on one principle clinical trial that demonstrated prolonged suppression of HIV-RNA and on two smaller supportive studies. Boehringer Ingelheim, the drug's manufacturer, does not intend to seek FDA approval.

On the other hand, the company is applying for approval of another drug in the category, Tipranavir, which is a non-peptidic protease inhibitor (NPPI) for the treatment of HIV-1 infection in combination with other antiretroviral agents in patients who are protease inhibitor experienced. The application for approval is supported by data from Phase II and Phase III studies of tipranavir boosted with low-dose ritonavir (tipranavir/r) in more than 2,500 patients worldwide.

Recommended article: Why Merck did not recall Vioxx?

Vioxx recall facts must come out before lawsuits

The debate right now is shifting in the Vioxx recall scandal. Many experts are starting to say that it will be difficult for Vioxx victims to prove their case since it is not always easy to establish a direct correlation between an adverse side effect of Vioxx and taking the drug. Plus, many doctors have been surprised by the ferocity with which Merck has hit back at Vioxx victims. Several media reports indicate that Merck is planning to mount an aggressive fight (Didn't they say that customer was always right? Merck doesn't seem to give a damn about its customers though!). (Related article: Merck gets ready for an ugly fight in Vioxx lawsuits)

So while the board of directors at Merck acted after almost two months of inaction to appoint a committee to review what went wrong with Vioxx recall process, several experts are now questioning if it is not all part of a public relations exercise by the company to salvage its image after Vioxx killed so many people and caused severe side effects in tens of thousands more. Everyone in America (who has watched Enron, Worldcom, and others) knows that board of directors at most public companies these days are essentially golf-playing pals of the CEO, and rarely, if ever, criticize the management. (Related article: Merck board decides to review Vioxx recall steps)

Since Merck has so little credibility, the members of the committee are trying to create an impression that they will try to uncover the truth related to how Vioxx (sold as Ceoxx in some countries) resulted in deaths of tens of thousands of people all over the world.

John S. Martin, Jr., a retired federal judge, recently defended the committee in an interview with David Voreacos of Bloomberg News. "We are charged by the special committee to uncover the facts, which is what we will do," Martin said in the interview. "I'll be going back over the documentary record and talking to all the people involved to make sure that everything was done appropriately," Martin added. "We've got to be as thorough as we can. It could take months to complete."

Judge Martin is no ordinary judge. He is very independent and is highly respected in the community of judges and lawyers. In a 2003 article criticizing the federal sentencing guidelines, he wrote, "While I might have stayed on despite the inadequate pay, I no longer want to be part of our unjust criminal justice system." After writing that he decided to retire rather than continue as a judge.

It is very important that the facts come out in this case so that another Vioxx debacle does not happen. The manner in which Vioxx has been recalled has weakened the FDA and made many doubt the safety of our drug approval process. (Related article: Vioxx scandal shows how the FDA became a toothless agency)

Recommended article: Americans scared after Vioxx recall

Vioxx refund program changed by Merck

As many of you know, after the recall of Vioxx in September, Merck offered to refund your money if you sent the unused drugs to the company. The program was, however, unfriendly to consumers and too restrictive.

Attorneys General of several states today announced that Merck has agreed to significantly change its refund program for consumers who used Vioxx. Attorneys General from eight states contacted Merck in October after Merck withdrew Vioxx from the marketplace.

"Although we appreciated Merck’s decision to pull Vioxx off the shelves and provide refunds to consumers, the program was not only unduly burdensome, but it didn't provide the consumers with adequate notice," says Attorney General of Oregon Hardy Myers.

The original consumer refund program was designed to reimburse consumers for Vioxx they had on hand at the time of the recall. Among other things, the Merck program required consumers to return all unused Vioxx in its original packaging in order to qualify for a refund.

Shortly after Merck’s October announcement, Attorneys General wrote the drug company with suggestions about how its refund program should be changed. "Not only were there too many hurdles to jump before a refund was possible but it excluded consumers who might have immediately destroyed the Vioxx either on doctors’ orders or because they were worried about keeping an unsafe drug in their medicine cabinets," Myers explained.

The new refund program, now in effect, does the following:

• Provides consumers with remaining Vioxx, pre-paid mailers in which to return what has not been used. Merck will arrange for a home pick-up to avoid the consumer having to take the mailer to a post office.
• Allows consumers, who destroyed unused Vioxx under doctor’s orders or otherwise, to certify in writing that they had unused product on September 30, 2004.
• Extends the claim refund deadline from December 31, 2004 to March 31, 2005.
• Through its sales staff, Merck will contact rheumatologists and primary care doctors with information about the modified refund program that the doctors can then distribute to patients that were taking Vioxx.
• Merck will work with pharmacies to mail out updated refund notices to consumers who purchased Vioxx and who may be eligible for a product refund.
• Directly contacts consumers whose refund claims were rejected by Merck under the earlier refund rules that required product return.
• Makes a good faith effort to notify consumers about the refund program in future advertisements or print notices about Vioxx.

Recommended article: Complete coverage of Vioxx recall

Source: Oregon Dept. of Justice

Americans scared after Vioxx recall

Nearly half (48%) of U.S. adults and more than three quarters (78%) of Vioxx users report closely following the news coverage about the voluntary withdrawal of Vioxx from the market. Sixteen percent of U.S. adults report that they or someone in their household have taken Vioxx on a regular basis and nearly half (48%) of these users were taking the medication at the time of withdrawal.

These are some of the results of a Harris Interactive® poll of 2,065 U.S. adults conducted online between December 2 and 6, 2004 for the Wall Street Journal Online's Health Industry Edition.

Reactions to the withdrawal by adults living in households where someone was taking Vioxx at the time of the recall varied, but a majority did respond in some way when they learned the news. The most common action taken by Vioxx users was to consult with a doctor about switching to a new medication (50%). Nearly half (48%) reported switching to another prescription pain medication, 24 percent switched to an over-the-counter pain medication, and 21 percent stopped taking pain medication entirely. Notably, none of the users surveyed refilled a prescription for Vioxx via the Internet or some other means.

While the news coverage of this withdrawal has been quite extensive, it doesn't appear to have done much to minimize concern, as a majority (60%) of Vioxx users are concerned that their health or the health of their family members might be negatively affected by taking the medication.

In the wake of the criticisms that have leveled against Merck & Co., the manufacturer of Vioxx, and the U.S. Food and Drug Administration (FDA), Americans are divided or uncertain as to whether or not they feel that these institutions acted responsibly with regard to the drug's withdrawal. By 43 to 22 percent, adults believe the FDA acted responsibly, however 35 percent are not sure. Merck was not viewed quite as favorably with virtually no difference in the percentage of adults saying it acted responsibly vs. those saying it did not act responsibly (32% vs. 31%), and another 37 percent saying they are not sure.

Recommended article: Vioxx most dangerous drug in Cox-2 category

Source: Harris Interactive

FDA critic Dr. Graham recognized by Forbes

If you are a Vioxx victim, you have probably heard of Dr. David Graham. Otherwise, for vast majority of Americans, Dr. Graham does not exist. But Dr. Graham may have done the greatest service to the nation by exposing that the Food and Drug Administration Agency (FDA) was incapable of defending the American public against another drug disaster.

Now Forbes magazine has declared Dr. Graham as the annual Face of the Year for his "steadfast advocacy of drug safety and his willingness to blow the whistles on his bosses." According to Forbes.com Medical and Science Writer Matthew Herper, Graham was a steadfast watchdog on drug safety long before the Vioxx recall. "Without Graham, the Vioxx debacle might have been seen as an isolated event. But because he was willing to step into the spotlight, the withdrawal of Vioxx from the market looks like part of a systemic failure to properly weigh the risks and benefits of drugs."

Drug safety has been the big issue of the year, and Graham's actions will cast a long shadow for patients, doctors, and the $450 billion global drug industry. Do not forget that the current administration and the FDA have been denying the opportunity for poor Americans to import prescription drugs from Canada on the excuse that Canadian drugs may not be safe. Now what Dr. Graham is saying is that there is no guarantee that the drugs being sold in the United States right now are safe since the FDA is literally a lap dog of the pharmaceutical industry. Not only does it rely on the drugmakers for test data, it also is full of so many industry insiders that it dare not say anything against the industry - something that has been so obvious in the recent Vioxx scandal in which FDA has consistently sided with Merck rather than speak out to protect the interests of American people.

Why is the recognition of Dr. Graham by Forbes important? Because this is not a magazine that likes government or federal agencies or even government employees. Consistently coming up with anti-government themes, Forbes is not a magazine that likes anyone who criticizes greedy corporations. If the magazine has made an exception in the case of Dr. Graham, what it means is that folks like Matthew Herper understand that if Americans (and the world at large) loses confidence in the FDA, not only is it disastrous for the Americans, it is also disastrous for pharmaceutical companies. When you pop a pill, you are essentially putting your life in the hands of a drug company and when that trust is broken (as Merck did in the case of Vioxx), you will think ten times before popping a pill (particularly when it is made by Merck).

The Japanese government has never trusted the American drug approval process and an American drug trying for approval in Japan has to start from scratch. In the past, this process was described as anti-competitive behavior by the Japanese government designed to keep out competition but it seems that they were doing the right thing. What happens when other governments start questioning the credibility of the FDA?

Recommended article: Vioxx critic Dr. David Graham may lose his job for criticizing the FDA

Source for part of the article: Forbes

Vioxx class action lawsuit filed in Arizona

A Phoenix resident, Edward W. Wright, today filed a proposed class-action lawsuit against Merck & Company in Arizona Superior Court through Rob Carey and the Hagens Berman law firm. This is the first statewide class action in Arizona, United States. Once certified by the court, the suit will represent any Arizona resident who purchased Vioxx over the past four years.

According to the complaint, consumers of Vioxx would have not have purchased the drug if the company fully disclosed the associated risks. "Consumers all across Arizona purchased Vioxx, paying more than $2 a pill, about one hundred times the cost of regular aspirin," said Carey, a former Arizona chief deputy attorney general. "We believe that in addition to being held responsible for the enormous health implications, the makers of Vioxx owe consumers a financial obligation to return the huge profits they made in selling such a horribly flawed drug." Carey currently represents dozens of individuals who took Vioxx and are evaluating their claims against Merck for personal injuries. (Related article: Vioxx most dangerous drug in Cox-2 category)

The lawsuit alleges that Merck violated Arizona's consumer fraud act and unjustly profited from its conduct. According to the complaint, internal e-mails show Merck executives knew that Vioxx had safety risks, noting in one correspondence that undisclosed risks were "clearly there." (Related article: Why did Merck now withdraw Vioxx?)

"We intend to prove that Merck executives intentionally and knowingly defrauded Arizona consumers by touting the benefits of this expensive drug, while withholding critical information about its shortcomings," Carey said. "Had consumers been given all the information we believe Merck possessed about the safety of Vioxx, consumers would have chosen other, safer, less costly alternatives."

Wright purchased Vioxx, unaware of the health risks associated with the drug, which the complaint claims Merck withheld. After taking the medication, Wright suffered a heart attack.

Recommended article: Vioxx class action lawsuits against Merck exploding


Source: Hagens-Berman

Vioxx critic may lose his job for criticizing FDA

One fails to understand why the FDA will be so eager to help Merck in the Vioxx recall case even if it means working against the interests of Vioxx victims in general, and Americans in particular. The evidence that is emerging indicates that Merck may have made several mistakes in how it got Vioxx approved, how aggressively it was marketed to consumers, and how it failed to recall it once data started to show that it was hurting arthritis patients.

One theory that is being circulated is that the Merck CEO and others in the pharmaceutical industry are very close to the Administration and have very close friends in powerful positions. Plus, Merck and others in the drug sector have contributed enormous sums of money to 2004 political campaigns. (Related article: Vioxx recall and Washington politicians)

For a while it has been known that the FDA has been harassing Dr. David Graham, an expert at the FDA, who had the courage to expose the inner workings of the agency and tell Congress that there are many other drugs like Vioxx on the market and that the FDA is not really capable of ensuring the health and safety of Americans. His bold approach has not made him many friends at the Agency and since then he has been fighting to keep his job.

Members of Congress have tried to come to his help, specifically Senator Grassley, and now Congressman Bart Stupak. In response to reports that the Food and Drug Administration (FDA) had asked Dr. Graham to leave his position and move elsewhere in the agency, Congressman Stupak and 21 other congressional members have demanded assurance the whistleblower will keep his job. The members also asked in the Dec. 10th letter to FDA Acting Commissioner Lester M. Crawford that he investigate the smear campaign conducted by some within the agency against Dr. David Graham.

According to reports, Crawford had asked Graham to leave his position within the Office of Drug Safety and move to another part of the agency soon before Graham testified before the Senate Finance Committee about FDA oversight on certain prescriptions drugs, such as Vioxx. Graham, a 20-year veteran at the FDA, was asked by members of the Committee, based on his expertise, if there were any other drugs that should be pulled from the market. Graham named five: the acne drug, Accutane; the weight loss drug, Meridia; the anti-cholesterol drug Crestor; the pain reliever Bextra; and the asthma drug, Serevent.

"Dr. Graham has been a dedicated public servant, working to ensure the safety of America's drug supply. If these reports are true, then this latest action is out of line, and very well may be illegal," the members wrote. "Dr. Graham was asked to testify before Congress at the request of the Committee Chair and was under obligation to answer questions posed by the Committee based on his expertise. The public’s interest is not served when he is asked to leave for doing his job."

The letter also stated that the treatment of Graham will have a chilling effect on FDA employees to speak up and disagree when they believe the public's health is at risk. In addition, Stupak and members said they were concerned by reports that some FDA managers launched a smear campaign to discredit Graham. The House members have asked Crawford what plans the FDA has to take disciplinary or other action against those individuals who may have attempted to discredit Graham.

Recommended article: Vioxx scandal shows how FDA became toothless

Vioxx recall calls for management changes at Merck

The manner in which Vioxx recall has been handled by Merck and the poor strategy the firm has been working on all along calls for major management changes at the seniormost level at the company. Unfortunately, Merck board has been rather slow to act and has not been very decisive so far. Only after more than two months since the withdrawal of Vioxx did the board act to appoint an independent committee to investigate what went wrong with Vioxx. So far there is no news as to what other management changes the board may be contemplating. In the meantime, Merck is being investigated and the number of Vioxx class action lawsuits is piling up.

Current Merck CEO Raymond Gilmartin, who not only is responsible for a flawed Vioxx strategy but is continuing to stick to a strategy that is no longer working, has vowed to stay in his job till his mandatory retirement age (that he will reach in March 2006). In an interview with Fortune magazine, Gilmartin came across as someone who did not care. As John Simons and David Stipp write, "Listening to Ray Gilmartin, you can't help but be struck by how matter-of-fact and calm the man seems...you'd hardly guess that he is facing the most serious crisis of his ten-year tenure atop the storied $22-billion-a-year pharma giant."

While the board may be being polite not to fire Gilmartin right now, it seems that the board wants to see change (after Gilmartin's retirement) at the top by bringing in someone with a fresh perspective. Kate O'Sullivan of CFO Magazine is reporting that Merck has hired Heidrick & Struggles International (a leading headhunter for CEOs) to find a replacement for Gilmartin. So it seems that Judy C. Lewent, executive vice president and CFO of Merck, who was expected to move into the corner office is fighting for her job, according to the magazine. In fact several analysts quoted in the article by Sullivan are speculating that Merck might have a totally new management team when the new CEO takes over in 2006. But the question is, If Merck will survive the Vioxx recall. With liabilities that some analysts estimate could be as high as $38 billion, impending patent expiration on Zocor and only a modestly full drug pipeline, it will be interesting if Merck is able to hire a CEO who can turnaround the company or should Merck be sold in pieces, as some analysts argue.

Recommended article: Merck's financials hurt by Vioxx recall

Websites mentioned: Fortune CFO Heidrick & Struggles

Vioxx lawsuits against Merck rapidly growing

The number of Vioxx lawsuits against Merck is exploding. The lawsuits are being filed so fast that no accurate count is available but most estimates put the number at about 400. The complaints range all the way from gastrointestinal bleeding, cardiovascular events and kidney damage to heart attacks and deaths. Some of the names mentioned in the lawsuits are those of Elizabeth Aiken, Sidney Schneider, Sharon Scott Jones, and Robert V. Purcell.

While most of the action has been in the United States, Vioxx (also sold as Ceoxx in some countries) victims outside the US are also lining up to join the class action lawsuits. Two law firms in Australia Duncan Basheer Hannon and Slater and Gordon are taking the lead there.

Kenneth B. Moll & Associates, Ltd. filed the first worldwide class action lawsuit against Merck. The firm claims that it has already received inquiries from persons who believe they were injured by Vioxx in over 14 countries (China, South Africa, Italy, Canada, Iceland, Israel, Chile, United Kingdom, New Zealand, Brazil, The Netherlands, Singapore, the United States, and other countries). The lawsuit, known as the "VIOXX Class Action" was filed in the Federal District Court for the Northern District of Illinois.

Attorney Kenneth Moll said, "A primary goal of the Vioxx Class Action is to inform consumers and physicians worldwide of the potentially deadly side effects of Vioxx." Mr. Moll said that he is concerned that thousands of people have been injured by the drug and are not aware of their injuries. According to the experts at the law firm, a person is susceptible to a Vioxx injury beginning from the initial dosage, up to and including a week after discontinuing use of the drug. The lawsuit will request that a medical monitoring fund be established to enable people who have taken Vioxx to monitor the existence of dangerous side effects.

Kenneth B. Moll & Associates, Ltd. is also representing consumers of Vioxx, on an individual basis, who were seriously injured or died as a result of taking Vioxx. The firm's offices are working in conjunction with attorneys around the world. Another law firm that is actively helping non-US victims of Vioxx is The Law Offices of Bagolie Friedman.

Recommended article: Vioxx/Ceoxx lawsuits for non-US residents

Vioxx most dangerous drug in Cox-2 category

Researchers have discovered additional evidence -- now at the molecular level -- that point to important differences between Vioxx and other COX-2 inhibitors. In a new study, it was observed that Vioxx caused biochemical changes that contribute to the development of heart disease. Celebrex, another widely prescribed COX-2 inhibitor, did not. The findings published in a leading cardiovascular journal, Atherosclerosis, present a biological explanation for reported differences in cardiovascular safety observed with COX-2s. The independent study was conducted by Elucida Research LLC, a private laboratory in Beverly, MA, dedicated to independent and innovative biomedical research. (Related article: Vioxx recall focuses limelight on COX-2 inhibitors)

Over the course of a two-year investigation, researchers found important differences in the way each COX-2 inhibitor acts on a key process linked to cardiovascular disease. Vioxx made certain lipid components of the blood, particularly low-density lipoprotein (LDL, "bad" cholesterol), more susceptible to free radical damage -- chemical changes that contribute to heart disease.

"Vioxx interacts at the molecular level in a way that Celebrex and other NSAIDs do not," explained lead investigator R. Preston Mason, Ph.D, president and founder of Elucida Research LLC and a faculty member at Harvard Medical School. "Lipids are important molecular building blocks in cells of the artery. Abnormal changes in the structure or shape of lipids caused by Vioxx, especially in LDL, may explain why they are more susceptible to oxidative damage, and therefore, contribute to cardiovascular damage. Similar effects on susceptibility of lipids to oxidative damage have been observed with cigarette smoking, diabetes and in patients who have had a recent heart attack. Interestingly, these adverse effects were independent of Vioxx's function as an inhibitor of the COX-2 enzyme -- thus explaining why it could be different from other drugs in its class." (Related article: Vioxx more dangerous than Celebrex)

These findings are consistent with clinical evidence demonstrating a marked difference between Vioxx and Celebrex. A recent FDA-funded retrospective analysis of 1.4 million patients showed that patients taking higher doses of Vioxx (more than 25 mg daily) had triple the risk of heart problems, including heart attacks and sudden cardiac death. Patients taking Celebrex demonstrated no increased risk of acute cardiac events.

"This news should be reassuring to patients and doctors," said Mason. "The cardiovascular issues associated with Vioxx should not be extrapolated to other COX-2 inhibitors. Having for the past fifteen years studied these types of drug-lipid interactions, it was clear to us that the effects we observed with Vioxx were very unusual and needed to be reported to the medical community."

To further test their hypothesis, researchers validated the findings at an independent laboratory at Tufts University in Boston. The scientists at Tufts were blinded to the COX-2 medications used. The study involved an analysis of the effects of each of the COX-2 inhibitors on the biochemistry of human blood samples through techniques not available in clinical practice. Whole plasma, isolated LDL particles and cell lipid components that did not contain the COX-2 enzyme were analyzed with advanced biochemical techniques while the effects of the drugs on lipid structure were analyzed by small-angle X-ray diffraction.

Recommended link: Warning issued on Vioxx alternative Bextra

Other links mentioned: Atherosclerosis Tufts University

Warning issued on Vioxx alternative Bextra

Since the recall of Vioxx, doctors in the United States have been prescribing two alternative drugs: Celebrex and Bextra. While conclusive evidence is not yet available if these two drugs are less dangerous than Vioxx, a recent study simply suggests that Vioxx was definitely more dangerous.

From today onwards, however, Bextra will come with a new warning. "FDA believes that, based on what we know now, the overall benefit of Bextra outweighs the risk when used in properly selected patients as directed in the approved labeling," the FDA said in a statement. A study of more than 1,500 heart surgery patients found 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, the agency said.

The new label strengthened the warning about the possibility of serious skin reactions, including two types of reaction that can result in death (Steven-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN). It also added a new warning about possible heart and blood clotting problems, particularly in patients who have just had coronary artery bypass graft surgery (CABG)

FDA says that it will continue to monitor the side effects related to Bextra and take additional actions as appropriate. FDA continues, "As we have previously announced, FDA will also hold a public advisory committee meeting in February to discuss safety concerns of all marketed COX-2 and related drugs, including Bextra." (Related article: Vioxx recall focuses limelight on Cox-2 inhibitors)

FDA reports that other COX-2 selective NSAIDs and traditional NSAIDs such as naproxen and ibuprofen also have a risk for these rare, serious skin reactions, but these serious side effects appear to occur more often for patients taking Bextra than for other COX-2 agents. Bextra can also cause stomach ulcers, burning pain in stomach, dark stools or blood in stool, vomit that looks like blood, rashes and other skin reactions, and chest pain.

In summary, what the FDA is telling Americans, who may be taking Bextra, is to think again and discuss their situation with their doctors.

Related article: Alternatives to Vioxx are not all totally safe

Source: FDA

Vioxx recall scams and deceptive advertising explode

We continue to get numerous reports of scams and fraudulent business practices targeting Vioxx victims. Since the recall of Vioxx (Ceoxx in some countries), it seems that not only spammers but also all types of other crooks (sadly enough, a very small number of attorneys too) have decided to prey on ordinary folks injured by Vioxx. Here is a partial list of scams that have been reported to us by our readers:

• Deceptive email or SPAM
• Websites that pretend to provide information for Vioxx victims in a search result but are essentially there just to contact a Vioxx attorney/law firm
• Deceptive direct mail
• Aggressive and obnoxious calls from telemarketers (if your phone is not listed in the do-not-call registry)
• Offers to extend cash advances in anticipation of settlements in the future

How to protect yourself from scams and fraud?

1. Do not respond to SPAM. You can even complain to the Federal Trade Commission.
2. Throw away direct mail if you think that it is deceptive.
3. Ask the telemarketers to take your name off their list and then sign up immediately with the do-not-call registry.
4. If somebody is pressuring you to take any action (e.g. sign up for a class action lawsuit related to Vioxx) without giving you enough time to research and think, you are probably dealing with a crook. A respected law firm that does business ethically will never force you to do anything until you are not comfortable with your decision.
5. Finally, do your research. If a website seems to have been created just to collect your information about Vioxx related lawsuits but does not have detailed information about the lawyers behind it, you must be very careful. Look for those websites that clearly list the name of the law firms/attorneys behind it, their contact information (including a physical location), and a phone number to contact.

Related articles:

Vioxx recall lawsuit cash advances: how do they work and should you get an advance?

How to protect yourself from Vioxx scams and fraud?

How to find a Vioxx attorney?

Avoid gold digger Vioxx lawyers

Vioxx recall lawsuit cash advances

Several people have written to us asking for advice on the Vioxx (sold as Ceoxx in some countries) lawsuit cash advance offers being made (e.g. by companies like Oasis Legal Finance and Vioxx lawyers working with such firms).

How does the lawsuit cash advance system work?

The financing firm will evaluate your case to determine if you have a high possibility of receiving compensation from Vioxx class action lawsuits. If they are satisfied and you also meet other criteria related to your credit report, they will extend an advance to you based on their calculations. Based on the time from extending a cash advance to you to the date of settlement, they will collect a fee.

Should you get a cash advance in Vioxx related litigation?

• Remember that there is no such thing as a free-lunch. For instance, if you borrow $1,000 from Oasis Legal Finance and your case takes about a year to settle, you will have to pay $1,600 to them.
• What if you do not receive any compensation? While the firm is unlikely to extend an advance to you if they have any doubt that you will not get a single penny and extend the advance much lower than the Vioxx recall lawsuit settlement, you still have to be prepared to give the money back, if need be.
• Have you considered other sources of financing if you badly need the money? May be you need to consider asset management and debt consolidation options? There are cheaper sources of money out there. If Vioxx lawsuit settlement results in a big payment for you, just wait for it to happen and then you can use that money wisely. Do not forget that several victims of mesothelioma or asbestos cancer and victims of Bhopal tragedy have yet to receive anything after more than 10 years.
• Finally, if you absolutely must, then this is an option you should explore but do your homework. Spend some time on their website analyzing their terms and conditions and only when you are satisfied you should begin the application process.

Recommended article: How to avoid bankruptcy?

Vioxx recall focuses limelight on Cox-2 inhibitors

The class of drugs known by the technical name Cox-2 inhibitors has come under increased scrutiny since the recall of Vioxx. While a recent study did show that Celebrex was not as harmful as Vioxx (despite both drugs being in the same Cox-2 inhibitors category), future priorities will be to demonstrate the safety of COX-2 inhibitors as a drug class; to better understand past problems and; to optimize future agents both with respect to traditional indications (inflammation/hyperalgesia) and the next wave of novel applications including Alzheimer's disease and chemoprevention.

Research and Markets says in a report published that, "During the 1970s it became apparent that multiple COX isoenzymes may exist and this led to the eventual cloning of COX-1 and COX-2 in the 1990s. This report pays especial attention to the COX-1 and COX-2 isoenzymes. In addition the recently identified COX-3 is introduced as a novel target for analgesics. Although Vioxx and Celebrex were the first specific COX-2 inhibitors to enter the market Nimesulide, Etodolac and Meloxicam were available much earlier and these agents were all found to be COX-2 selective. This report describes the therapeutic activity of these agents and then continues with a thorough evaluation of all approved COX-2 inhibitors and those in late stages of development."

The first two COX-2 inhibitors to be approved, Vioxx and Celebrex, are as effective as non-selective NSAIDs in reducing stiffness associated with osteoarthritis as well as pain in a wide range of conditions. Observations that the incidence of ulcer complications is reduced compared to other NSAIDs are consistent, however, the pivotal safety trial VIGOR and CLASS have revealed apparent differences between the two drugs.

VIGOR demonstrated a clear reduction in gastrointestinal adverse events but an increased incidence of non-fatal myocardial infarction in Vioxx treated individuals compared to those receiving naproxen. CLASS on the other hand failed to show a difference in cardiovascular risk with Celebrex compared to patients receiving either diclofen or ibuprofen, however, the primary end point of ulcer indications was not altered either.

Critics claim that VIGOR demonstrated the cardiovascular risk of Vioxx, a view supported by an increase in blood pressure in patients with controlled hypertension; increased risk in the elderly and retrospective analysis of medical records. Supporters counter the claim citing the safety record of Vioxx in placebo controlled studies and in studies comparing Vioxx to other NSAIDs, and explain the VIGOR data as an "artifact" of the cardioprotective effect of naproxen.

Further analysis of CLASS suggests that the lack of improved gastrointestinal safety was because patients were allowed to take aspirin. When only patients not taking aspirin were investigated or when the combined incidence of ulcer complications and symptomatic ulceration was taken as an end point Celebrex demonstrated improved gastrointestinal safety.

Recent interim analysis of the APPROVe study designed to compare the chemoprotective effect of Vioxx to placebo demonstrated an increased incidence of myocardial infarction after 18 months treatment with Vioxx. The report provides an in depth argument on the safety of Vioxx in light of this trial discussing how convincing the arguments for and against a cardiovascular risk are, and if there is a risk, possible mechanisms. The effects of these three pivotal trials has however been that Vioxx was withdrawn by Merck in October 2004 while its main competitor, Celebrex has not been allowed by the FDA to claim improved gastrointestinal safety on its prescribing literature.

Given the issues surrounding the clinical data for Celebrex and Vioxx, the development of second generation COX-2 inhibitors takes on extra importance and the report fully evaluates Pfizer's Bextra and Dynastat which have been launched in the US but not Europe and Merck's Arcoxia which has been launched in Europe but not the US. The report also evaluates Novartis' Prexige which is of particular interest since its structure is novel and also because it offers the greatest COX-2 selectivity of all COX-2 inhibitors that have entered advanced stages of development. Most importantly, in the pivotal TARGET trial, the incidence of ulcer complications was significantly reduced in patients taking Prexige compared to those receiving NSAID. TARGET also demonstrated that the risk of cardiovascular events did not differ between Prexige and the pooled NSAIDs data irrespective of aspirin use.

Having fully profiled current COX-2 inhibitors, the report continues with an in depth look at the market. It is estimated that over 80m people worldwide take prescribed NSAIDs daily. The US COX-2 inhibitor market has previously seen high double digit prescription growth but this has declined over the last few years following fears that COX-2 inhibitors may lead to increased risk of cardiovascular events even before the release of the APPROVe trial data. Consequently the proportion of COX-2 inhibitors prescribed has stabilized out at around 30% of the total NSAID market. As a result of Vioxx's withdrawal the market will change still further. Within 24 hours of Merck's announcement approximately 2.4% of the 1.2 million Vioxx prescription holders in the US had received new prescriptions for alternative therapies. Of those active prescriptions, 58% had moved to other drugs within the COX-2 inhibitor therapeutic class, while 33% received a prescription for a NSAID such as naproxen. Among competitive COX-2 products, prescriptions for Pfizer's Celebrex and Bextra increased 78%, while prescription strength NSAID dispense rates increased 17% for the same three-day time period. Of current US Vioxx prescription holders 32% had taken the drug for more than 18 months, the timeframe in which Merck cited that individuals would be at risk for increased cardiovascular events.

From now on the FDA and European regulators will closely monitor other COX-2 inhibitors for similar side effects and the report concludes that this will delay the approval of Arcoxia and Prexige. In addition further cost-benefit analysis will be required to justify the use of COX-2 inhibitors over NSAIDS in chronic conditions. In order to prevent a further dampening down in the growth of the COX-2 market the report also concludes that it may be necessary for the existing COX-2 players to invest in educational and advertising campaigns to reassert the safety of COX-2 inhibitors in the chronic treatment of rheumatoid arthritis and osteoarthritis and allay patients and physicians safety fears.

Recommended article: Novartis offers a Vioxx alternative using a Cox-2 inhibitor

Source: Research and Markets

Vioxx recall may result in fundamental changes in drug approval

The recent case of Vioxx withdrawal and suspicion over other blockbuster drugs have intensified pressures on pharmaceutical companies to disclose all negative as well as positive results of industry-sponsored clinical trials. However, for most pharmaceutical companies, processes for monitoring drug safety are scattered throughout the organization. To give a complete picture of a clinical trial, pharmaceutical firms must integrate data from trial protocols, patient records, clinical records, adverse event reports and genomic data. Currently, no solution capable of meeting these needs exists. Life Science Insights predicts that the first vendor to market with a comprehensive solution will own the space.

Merck is not the first company that has done a poor job of acting on information from studies after the launch of a drug. Many experts have complained that the approval for Vioxx was given in a hurry without adequate testing. If that was the case, the FDA should have been more vigilant in monitoring drug performance after the approval. Since FDA did not do that, Merck took advantage of the situation and tried to suppress data that was definitely not going to help its top and bottom lines. (Related article: Why Merck did not recall Vioxx?)

Life Science Insights predicts that technology spending will increase in later stages of the pharmaceutical value chain, in areas such as clinical trial management systems, electronic data capture, and electronic lab notebooks. Spending on technology for classic discovery and development will remain flat. To make the R&D for drug faster and more accurate, pharmaceutical companies are increasingly looking for a low-cost edge. R&D is a good place to look, especially as countries such as China and India ramp up their R&D capabilities. Academic institutions will play a more significant role in commercial drug discovery.

Pharma lawsuits by states' attorney generals will drive a new market for compliance software, and make Sarbanes-Oxley look like a picnic. After all, the health of Americans is a responsibility of everyone and the pharmaceutical companies should not be the one to take advantage of a weakened FDA.

Life Science Insights is further stating that the pendulum is slowly swinging back to tools and platforms and the rush to revenue is decreasing. Technologies that enable the drug discovery and development process will see increased funding in the near term. Drug companies are under tremendous pressure to reduce the product development cycle for drugs and that means relying on less pre-launch data. The Vioxx debacle has shown that while new drugs should be available to Americans as soon as possible, it does not mean that they be can used as guinea-pigs by the drug industry.

Recommended article: Merck sued by New York State over Vioxx recall

Source: Life Science Insights

Merck's financials hurt by Vioxx recall

Merck is reporting today that its financial situation will deteriorate during 2005 due to the recall of Vioxx. Merck anticipates fourth-quarter 2004 earnings per share (EPS) of $0.48 to $0.53, which includes the impact of approximately $700 to $750 million in foregone sales of VIOXX and potential additional fourth-quarter costs for the withdrawal of VIOXX.

Like in any press release related to financials of a company, Merck has tried to put a positive spin on almost everything. Merck also says, "This guidance does not reflect the establishment of reserves for any potential liability for settlements relating to the VIOXX lawsuits." In today's statement, the company didn't disclose plans to set aside money to cover potential settlements. In other words, the company is trying to create an impression that Vioxx liabilities are not an issue to be bothered with at this time, though everyone knows that everything could fall apart if Vioxx victims can prove that the company knowingly sold a deadly drug. (Related article: Merck's Vioxx liabilities could be $38 billion)

Patrick Kaser of Brandywine Asset Management in Wilmington, Delaware, is quoted by Bloomberg as saying, "Merck can handle $10 billion to $20 billion (in Vioxx liabilities) easily without breaking a sweat in terms of balance sheet strengths. The bigger concern for Merck is what multiple do you put on it when earnings growth may be nonexistent for several years." In simple words, investors are worried that the impact on Merck will be far greater than the company is prepared to admit.

Recommended article: Merck Board decides to review handling of Vioxx recall

Merck decides to review Vioxx recall steps

Since the recall of Vioxx, Merck has been accused of taking a very callous approach, particularly its attitude towards Vioxx-related deaths. Not a word of apology has been offered by the company. Instead, news reports indicate that Merck is taking a very antagonistic approach and is preparing for an ugly court battle.

None of this has helped the company. The stock price has dropped and there are reports that Merck employees are looking for new jobs as headhunters are now starting to call them. In the meantime, Merck management was able to convince the board to approve a severance package ostensibly to retain key executives, but it was a public relations disaster since everyone assumed that senior managers wanted to put their personal interests over those of its customers and lower level employees. (Related link: Merck management prepares for possible takeover by protecting the interests of senior managers)

The behavior of the board of directors has been criticized and it has been hypothesized that board members may have failed to comply with the spirit of the Sarbanes-Oxley Act by letting the company pursue a flawed Vioxx recall strategy. (Related article: Merck's directors not acting in the interests of the shareholders)

Looks as if Merck's board is finally acting and announced today that it has appointed a Special Board Committee to review the company's actions prior to Merck's voluntary withdrawal of VIOXX, to act for the Board in responding to shareholder litigation matters related to the withdrawal of VIOXX and to advise the Board with respect to any action that should be taken as a result of the review.

William G. Bowen, Ph.D., president of The Andrew W. Mellon Foundation and chair of the Merck Board's Committee on Corporate Governance, will chair the Special Committee. "Even though the FDA has noted that the company acted responsibly with respect to VIOXX, the Board concluded that its responsibilities to Merck shareholders made it important to conduct an independent review in order to ensure that the company acted in an appropriate and ethical manner," said Dr. Bowen. Merck Board members who also will serve on the Special Committee are: Lawrence A. Bossidy; William N. Kelley, M.D.; Rochelle B. Lazarus; Samuel O. Thier, M.D. and Peter C. Wendell.

"The Committee will have the complete cooperation of Merck management and the full resources it needs to conduct its assessment. Merck management looks forward to the results of the Special Committee's review and is convinced that it will show that the company acted responsibly and appropriately," said Raymond V. Gilmartin, chairman, president and CEO of Merck.

The Honorable John S. Martin, Jr., Of Counsel at Debevoise & Plimpton LLP, has been retained by the Special Committee to assist with the independent review. Prior to joining Debevoise in 2003, Judge Martin served for 13 years as the U.S. district judge for the Southern District of New York and for three years as the U.S. attorney for the Southern District of New York.

Recommended article: Merck is a classic example of shareholder value destruction

Merck gets ready for Vioxx lawsuits

As we have been reporting since the recall of Vioxx in late September, Merck is getting ready for a strong fight. Instead of admitting that it made a serious mistake that led to tens of thousands of deaths worldwide (Related article: Why Merck did not recall Vioxx?), the company will instead try to prove that victims who died did not die due to Vioxx but due to other causes. Similarly, those who suffered heart diseases, other cardiovascular complications, and side effects, will have to prove that Vioxx was the reason for their illness. Merck will use every argument in its arsenal to make it difficult for each Vioxx victim to get a penny out of the company despite the fact that analysts expect that Merck's Vioxx related liabilities may be as high as $38 billion.

While some data has been published that shows that Vioxx was more likely to cause heart problems than other drugs, it may not be so easy to establish in individual cases that a death occurred solely due to Vioxx. Since each Vioxx victim will have unique medical condition, it may be difficult to certify these cases as a class despite the efforts of lawyers active in this area. A panel of federal judges is scheduled to decide in January whether to merge Vioxx cases against Merck around the country in one federal court for consolidated or coordinated pretrial proceedings, as well as to choose the judge who will hear the case.

To mount such a big fight will be very time consuming and expensive. So Merck is reaching out to some of the top law firms in the country to work on the case. Lily Henning of the Legal Times is reporting that the company has hired a handful of firms for its defense despite the fact that it does not like outside firms and relies heavily on its in-house lawyers.

Hughes Hubbard & Reed, a 300-lawyer New York firm for which Merck is already a major client, is serving as the Merck's national counsel in the Vioxx suits. Reed Smith, Baker Botts, Dechert, and Venable have also been hired, according to court filings.

It has also been reported by Henning that Merck is trying to pick the courts in such a way that they will favor its position. For instance, it is trying to get appeal hearings in front of the Fourth Circuit, a court that is highly conservative (most appointments were made by Republican presidents) and typically favors corporations over Americans.

While having such high profile law firms means that Vioxx victims will have to be extra careful in picking their attorney (Related article: How to pick a Vioxx attorney?), it may also mean that the company may be mired in legal troubles for years and eventually go out of business or be acquired for peanuts. It is already being reported that Merck employees have started to look for new opportunities outside Merck.

Recommended link: Complete coverage of recall of Vioxx and lawsuits against Merck

Novartis offers Vioxx alternative

Since the recall of Vioxx, a blockbuster drug (meaning sales of $1 billion or more), Merck's competitors have rushed to offer alternatives. After all, it is an opportunity of a lifetime. Recently released data suggests that most of the market share has now been grabbed by Celebrex and Bextra. Another study released yesterday shows that while Celebrex belongs to the same category as Vioxx (Cox-2 inhibitors), Vioxx was way too dangerous a drug. This will definitely help Celebrex. (Related article: Vioxx alternatives may not be totally safe)

At the same time, there are reports that a lot of other Vioxx alternatives are being proposed. New data from two studies provide strong evidence that the selective COX-2 inhibitor Prexige (lumiracoxib), manufactured by Novartis, taken daily at 100 mg offers reduced pain intensity while improving the functional status of patients' osteoarthritis (OA) of the knee. These data were presented at the Osteoarthritis Research Society International annual meeting in Chicago on December 4.

The data shows that over the 13-week study Prexige 100 mg once daily significantly reduced OA pain intensity in the target knee compared to placebo and was comparable to celecoxib 200 mg once daily. In the first study, Prexige demonstrated significant improvements in pain intensity from the first measurement at Week 2 with a significant reduction of 42% in pain intensity at study end (p<0.01 vs placebo).

A similar decrease was observed in the second study with significant improvements throughout the study and a 38% decrease in pain intensity by study end (p<0.001 vs placebo). Throughout the study Prexige and celecoxib demonstrated significant improvements in functional status in both studies compared with placebo, with no statistically significant difference observed between active treatment groups.

In both trials, the number of patients discontinuing treatment due to adverse events, including serious adverse events, was similar between placebo and the active treatment groups. Furthermore, no significant difference was observed between all treatment groups for the incidence of liver enzyme elevations, defined as alanine aminotransferase/aspartate amino-transferase levels above three times the upper limit of normal. In the first study enzyme elevations with Prexige were 0.2%, celecoxib 0.5% and placebo 0.5%, and Prexige/celecoxib 0.3% and placebo 0.0% in the second study. These data reinforce the existing body of evidence showing a favorable safety and tolerability profile for Prexige.

Though data regarding gastrointestinal (GI) and cardiovascular (CV) adverse events were not evaluated separately in these trials, results from the landmark TARGET (Therapeutic Arthritis Research & Gastrointestinal Event Trial of lumiracoxib), which were published in August 2004 in The Lancet, demonstrated a significant 79% reduction in the incidence of upper gastrointestinal (GI) ulcer complications without compromising cardiovascular (CV) safety. The TARGET trial demonstrated that Prexige has a cardiovascular profile similar to conventional non-steroidal anti-inflammatory drugs (NSAIDs) ibuprofen and naproxen.

The two similarly designed 13-week, randomized, placebo and active-controlled trials compared Prexige 100 mg once daily, Prexige 100 mg once daily with a loading dose of 200 mg once daily for the first two weeks and celecoxib 200 mg once daily to placebo. Both trials were designed using three co-primary efficacy variables including functional status assessment criteria: OA pain intensity in the target knee, patient's global assessment of disease activity and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC™) questionnaire. Improvement in patient's functional status was further assessed using the OMERACT-OARSI functional status criteria.

Novartis has filed applications for regulatory approval throughout the world based on data from more than 40 pre-clinical and clinical studies in OA, rheumatoid arthritis, acute pain and primary dysmenorrhea involving more than 31,000 adult patients around the world (including TARGET). In addition to the United Kingdom, Prexige has been approved in 21 countries to date, including Australia, New Zealand and several countries in Latin America, including Argentina, Brazil and Mexico. On November 30, 2004, Novartis announced that it had 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.

Recommended article: Non Cox-2 alternatives to Vioxx for pain relief

Vioxx scandal shows how FDA became toothless

The fact that the FDA is literally powerless in controlling the pharmaceutical industry has caused a lot of concern in the minds of Americans who are essentially at the mercy of for-profit drug companies, which as the Vioxx recall example shows, put profit ahead of human life. But it is obvious that we can't have it all. On one hand we can not ask for small government, and on the other hand, we can't expect the government to be there to protect us.

As is no secret, many of the federal agencies continue to face budget cuts and have either cut back on what they do and how they do it or rely on private sector to help out. Most Americans love it when welfare programs are cut or health care for poor children is eliminated or benefits for immigrants are cut but the Vioxx recall has really hit Americans in the face. Now Americans are seeing what happens when federal agencies become toothless due to shortage of funds.

The Seattle Post Intelligencer and The New York Times have found that:

• In the 2003 fiscal year, FDA received $200 million from the drug industry - but only if the agency spent a specified level of money on new drug approvals.
• In the past 11 years, spending on the reviews has increased to more than four-fifths of the budget of the agency's drug center from about half.
• Among the priorities that took the worst hit was ensuring the safety of the drugs that patients are already taking. It is clear that right now mechanisms for uncovering the dangers of drugs after they have been approved are woefully inadequate, particularly, as was the case of Vioxx
• FDA now relies almost entirely on the willingness of drug makers to report problems that crop up after a drug has been approved
• FDA cannot require drug makers to undertake safety tests once a drug is approved.
• The industry's influence even extends to perks given to agency employees. Under the 1992 agreement, last renewed in 2002, new drug reviewers have healthy travel and training budgets that allow them to attend far-flung conferences and courses. Those who work in the agency's office of drug safety get two-thirds less.

Recommended article: Reforms needed at FDA after Vioxx recall

Vioxx more dangerous drug than Celebrex

Maggie Fox, Health and Science Correspondent at Reuters who interviewed Dr. Stephen Kimmel of the University of Pennsylvania after publication of study on Celebrex is reporting that the drug is less likely to cause a heart attack than Vioxx, despite both drugs being in the same category, commonly referred to as Cox-2 inhibitors.

Pfizer has argued all along that Celebrex was safer than Vioxx and that has allowed it to gain most of the market share (along with Bextra) lost by Merck after the recall of Vioxx. But Dr. Kimmel does not seem to think that Celebrex is any safer than Vioxx. "The main finding is that people who use Vioxx have almost a three-fold higher risk of non-fatal heart attacks as people who use Celebrex," Kimmel said, adding he presumed the statistics for fatal heart attacks would be similar.

Harvard Medical School researchers -- Dr. Axel Finckh, a rheumatologist at Brigham and Women's Hospital and Dr. Mark Aronson of Beth Israel Deaconess Medical Center -- said doctors should avoid prescribing COX-2 inhibitors to patients who have a risk of heart disease.

Associated Press is quoting Dr. Garret FitzGerald, a Penn cardiologist and pharmacologist, who questioned whether it proved anything new. He is among a number of doctors concerned that all Cox-2 inhibitors, which block the enzyme that causes the pain and swelling of arthritis, may raise the risk of heart problems.

So what does it mean if you have taken Vioxx and your doctor has put you on Celebrex? Nothing much. As experts point out, more research is needed to prove if there is a truly safe drug for arthritis patients. The main message here is that if you have a heart condition along with arthritis pain, you need to have a serious discussion with your doctor to decide if you should be taking a Cox-2 inhibitor drug.

Related articles: Vioxx alternatives may not be totally safe and Non Cox-2 alternatives to Vioxx for pain relief

Vioxx recall leaves drug advertising unchanged

If you were expecting that Vioxx recall will put an end to direct-to-consumer advertising, then you have been proved wrong already. In fact since the recall of Vioxx, the level of advertising for all drugs remain unchanged but for alternatives to Vioxx, it has gone up.

Is direct-to-consumer advertising helpful?

No one can argue against the value of information provided to people so that they can take better care of their health. When Americans take better care of their health, we prosper as a nation. But that is not what direct-to-consumer advertising does today. Right now, the idea behind advertising is to talk about specific drugs and ask consumers to get treatment for that illness by asking specifically for that drug. So there is plenty of advertising for ED but hardly any advertising for obesity. What information is provided to consumers is determined by advertising dollars for a specific drug that a company wants to spend. The result: consumers don't get good information for improving their overall health but get bombarded with ads for Viagra or Claritin or Lipitor (and Vioxx in the past).

The drugmakers disagree. PHRMA, the association of pharmaceutical companies, cites a study that showed that:

• 56 percent of physicians agree that direct-to-consumer advertising brings in patients to seek treatment that would otherwise go untreated
• 28 percent of those who contacted a doctor because of direct-to-consumer advertising report that it was the first time they talked to their doctor about a condition
• 22 percent reported that the advertising prompted them to talk to a doctor earlier than they would have otherwise

But it is also true that direct-to-consumer advertising led approximately 100 million people worldwide to take Vioxx and tens of thousands of them have now been killed.

How to provide good health related information to consumers?

If the drug companies want to spend their $21 billion on improving the health of Americans, this money should be given to a non-profit group that can run public service ads without mentioning any drug names. So along with frequent reminders to brush your teeth, they can also ask people to check their cholesterol regularly.

Recommended article: Vioxx recall and role of direct to consumer advertising

Why Merck did not recall Vioxx

Several people have written to us expressing outrage at the behavior of Merck. The common question asked is How could a company be so greedy that tens of thousands of people were dying and the company continued to aggressively market Vioxx prior to its recall?

While the Vioxx example is not only a criminal act, it is also unethical by any standards. Particularly for a drug company. What Merck did in case of Vioxx is absolutely unforgivable, but to put Merck's behavior in context, let us review the dynamics of the pharmaceutical industry. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), as presented in their Pharmaceutical Industry Profile 2004 (Washington, DC: PhRMA, 2004), while extremely profitable, pharmaceutical industry has many challenges:

• On average, it takes scientists, physicians, engineers, and other researchers between 10 and 15 years and costs more than $800 million to do the research and testing to bring a new medicine to patients.
• In 2003, members of PhRMA spent an estimated $33.2 billion on pharmaceutical R&D—a sizeable increase over the previous year.
• The industry is one of the largest employers of scientists in the United States and its success or failure relies heavily on their ability to make breakthroughs.
• Pharmaceutical research company scientists earned FDA approval for an average of 32 new medicines a year over the past decade.
• Only 3 out of every 10 marketed Rx drugs produce revenues that match or exceed average R&D costs.
• Under current law, generic drug manufacturers can already infringe unexpired patents in order to prepare their copies for Food and Drug Administration approval and the market, and can—in an increasing number of instances—enter the market with their copies years before patents expire.

What does it mean?

Pharmaceutical companies are under tremendous pressure to come up with blockbuster drugs (over $1 billion in sales), like Vioxx, to pay for R&D of other failed drugs. The window of opportunity is extremely short, normally just about five years. A firm has to maximize its return on blockbuster drug by doing whatever it takes during that window.

What was Merck thinking in case of Vioxx?

A lot of what was going on at Merck can be easily explained by the very nature of the drug industry, but a few things that can be hypothesized are as follows:

• If Merck could stop establishment of a strong correlation between Vioxx and deaths of tens of thousands of cardiovascular complications in arthritis patients, there was no way to prove that something was wrong with Vioxx. There were two sources from such research could come:
  (a) FDA, but it is already controlled by drug industry insiders. To make sure that the FDA maintained a hands-off policy towards Merck (and the drug industry), Merck (and others in the drug industry) pumped millions of dollars in campaign contributions to the Republican party. (Related article: Vioxx recall shows FDA hijacked by drug industry)
  (b) Think tanks, research institutions, medical experts, etc., who did publish the research that raised doubts about Vioxx, but according to Dr. Eric Topol, Merck was pursuing an aggressive attack strategy under which any study that raised doubts about Vioxx was countered by Merck scientists and paid consultants who were bombarding medical journals arguing about the safety of Vioxx.

Recommended article: Vioxx recall is an example of risk management by Merck

CALPERS questions Merck over Vioxx recall

Citing concerns about the market fallout from the Vioxx uproar and the safety of drugs, the California Public Employees' Retirement System (CalPERS) is ratcheting up its pressure to solve the issue on its investment and health fronts. CalPERS is the nation's largest public pension fund with assets totaling $177 billion. The System provides retirement and health benefits to more than 1.4 million State and local public employees and their families.

CalPERS has sent letters to several drug companies demanding answers about how they will restore and retain shareholder value. CalPERS Chief Investment Officer Mark Anson recently sent letters to the chief executives of Merck and several other drug firms following Merck's withdrawal of Vioxx from the market after a study showed that the arthritis drug doubled the risk of heart attack and stroke.

The pension fund is also questioning its health partners about the steps they are taking to protect CalPERS members who use prescription drugs. Jarvio Grevious, Deputy Executive Officer for Benefit Administration, sent letters to Kaiser, Blue Shield of California, and Western Health Advantage - CalPERS health maintenance organizations (HMOs) - and to Caremark, the pharmacy benefits administrator for the System's preferred provider plans, PERSCare and PERS Choice.

"We find the accusations that the company had reason to believe that Vioxx may have potential safety concerns as much as a year prior to the removal, yet failed to disclose this information, deeply troubling," said Anson.

In letters to the seven drug companies, Anson asked companies to detail the steps they are taking to examine internal processes to ensure that similar Vioxx situations do not occur. He also challenged them to step up their efforts to keep existing drugs safe and address the conflict inherent in long-term product safety and short-term profitability.

As a long-term shareowner, Anson asked the companies to outline what steps they are taking to restore shareowner value and market confidence in the wake of these events, noting that Merck lost more than a third of its market value since the Vioxx issue surfaced. (Related article: Merck sued by New York State over Vioxx recall losses)

CalPERS is also taking issue with Merck's reported severance benefits plan to protect key managers if the company is taken over or liquidated. "The timing of the plan leaves the impression that your highest priority is protecting the economics of the management team rather than the owner," Anson said. "There are also several specific provisions within the plan that CalPERS finds particularly onerous." (Related article: Merck executives prepare for likely dissolution of the firm but protect senior level managers)

Anson requested a written response to the drug safety issues and "an initial call" to discuss Merck's executive compensation issues. CalPERS owns 11.2 million shares of Merck.

In the letters to its health plans, Grevious cited five drugs about which the FDA has expressed safety concerns, besides Merck's Vioxx. They are Accutane, a severe acne treatment; Crestor, an anti-cholesterol drug; Meridia, an obesity treatment; Serevent, an asthma medication; and Bextra, a painkiller. (Related article: All Vioxx alternatives may not be safe)

"Please explain what measures you have taken to ensure that the appropriate precautions have been implemented to protect our members. If any of the drugs in question are part of your formulary, please objectively support why you believe your formulary to be safe," said Grevious.

Recommended link: Complete coverage of Vioxx recall

Vioxx recall similar to Bhopal tragedy

It is ironical how 20 years after the Bhopal tragedy, the behavior of corporations has not changed much. While capitalism and free markets are noble goals, but not if these goals are achieved at the cost of human lives. When the Bhopal tragedy happened in a third-world country (that was also struggling with the assassination of its prime minister at that time), in a world without Internet and 24-hour news, the news was largely ignored in the United States. After all, it did not happen to us. Now that over 100,000 people have been killed by Vioxx, and many more who have suffered other serious side effects, we can now appreciate what it means when profits take precedence over human life.

Let us also look at other similarities in the behavior of Union Carbide and Merck. At that time, Union Carbide executives pleaded not guilty and refused to take responsibility for their actions, or lack thereof. After the company dragged its feet for years, the case was settled, but news reports indicate that the victims never really got much and some are still waiting for compensation. The former chairman of Union Carbide was never tried since he could not be extradited to India. Merck's behavior after recall of Vioxx definitely seems so similar.

How can we better handle tragic cases of victims of Vioxx recall?

1. It would be nice to see Merck take more responsibility for its lack of respect for human life.
2. We also will appreciate if the US administration does not create any barriers for prosecution of anyone who may be responsible for committing crimes, whether at Merck or at the FDA.
3. Vioxx victims will not be helped much if the compensation is not provided to them as soon as possible. If they have to wait 20 years like the Bhopal victims, irreparable damage will be caused to their health.

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

Vioxx recall liability for Merck could be $38 billions

In a research report released by the respected analyst, Richard Evans, of Sanford C. Bernstein, an investment research and management firm, it is being estimated that Merck's Vioxx liabilities could be as high as $38 billion, according to an item published by Forbes.

Since the recall of Vioxx, analysts have tried to estimate total liabilities of Vioxx and estimates have so far ranged from $10 billion to $18 billion. According to Evans, however, if all the patients who had heart attacks and received just average-sized legal settlements, Merck's liability could be as high as $38 billion. Or in other words, it could go up if even higher damages were awarded to Vioxx victims.

In Evans' opinion, there are as many as 58,000 Vioxx victims who have had heart attacks and their average settlement will be approximately $650,000. But remember that exact statistics are not yet known. From early reports of just 28,000 deaths from Vioxx, some estimates put that number at 155,000.

Merck stock has continued to fall since the recall of Vioxx and no one is sure if the current stock price truly reflects the risk inherent in the stock. Evans also cut his target price by 10% today.

Recommended article: How to pick a good Vioxx attorney?

FDA taken to task for Vioxx recall handling

United States Senator Charles E. Grassley, Chairman of the Senate Finance Committee is taking a very strong stance on how FDA has handled the Vioxx recall issue. In a previous letter to Office of Inspector General (OIG), Department of Health and Human Services, he had requested that he conduct a complete and thorough investigation into the facts, events, persons, policies, regulations and laws relating to allegations that a number of management level employees at the FDA may have acted to discredit Dr. David Graham who was challenging the FDA’s drug safety policies. (Related article: Senator Grassley demands investigation into harassment of FDA critic)

On November 18, 2004, in his opening comments at the Committee's hearing related to Vioxx, Senator Grassley stated that, "[T]he clarifications provided last night by Dr. Crawford appear intended to intimidate a witness on the eve of a hearing. . . . Dr. Crawford knows there's a problem and would better serve the FDA by spending time on the problem, rather than going after congressional witnesses who helped identify the problem in the first place."

As is being reported in several newspapers, rumors have been circulating that the top brass at the FDA is not pleased with Dr. Graham's statements, particularly those that talk about how dysfunctional the organization is and how as many as five drugs on the market may not really be safe. In his harshly worded letter to Crawford, Grassley asks him to cooperate fully with the investigation into the complaints, and adds, "I have requested that FDA employees be advised that they may come to Congress and speak freely without fear of reprisal. Do you believe that FDA employees are free to speak to members of Congress without advising FDA's Office of Legislation? If so, when are you going to act on this request?" He has also directed that all FDA employees must be told about this investigation and be notified that all records and documents relating in any manner whatsoever to this investigation, either directly or indirectly, must be preserved immediately.

It is since being reported that Crawford will be meeting with Grassley to address the concerns raised by the Senator.

Recommended article: Reforms needed at FDA after Vioxx recall

Vioxx lawsuits by non-US residents

After we published our first report on Vioxx recall cases outside the United States, there is some more good news for Vioxx recall victims. Some estimates put the number of these non-US Vioxx customers to be approximately 80 million, but due to the challenges of language, distance, expensive phone charges, and time difference, it is not always easy to find the right law firm in the United States.

Several Vioxx attorneys in the United States are now welcoming overseas Vioxx victims to contact them via email (the cheapest way to communicate if you live overseas). Typically, the Vioxx attorney has a simple form on its websites where you provide complete information about you, the lawyers evaluate your case to see if you are eligible to participate in the United States legal process, and then initiate contact with you to discuss the next steps.

The Law Offices of Bagolie Friedman has gone even one step further and has created the International Vioxx Practice Group specifically to work with Vioxx victims overseas, particularly in the UK, and Australia for now. The firm has tremendous experience in working with overseas clients since it has represented them when they were injured in any way while visiting the United States. The firm also has Spanish speaking attorneys on their team.

Related link for Spanish speakers: Vioxx abogados

Reforms needed at FDA after Vioxx recall

The manner in which approval of Vioxx and the events leading up to Vioxx's recall by Merck was handled by the FDA has not been appreciated by anyone. Several experts have called for another watchdog group while others have suggested a complete overhaul. Many doctors are concerned that if the world loses faith in the FDA, it will have disastrous consequences.

It is well known that pharmaceutical firms literally control everything that happens at the FDA. Not only do they spend millions of dollars in campaign contributions (mostly on Republican candidates who favor a totally relaxed approach to the drug industry and have blocked most efforts by poor Americans to import drugs from Canada), they also lobby the FDA. Many FDA staffers are essentially drug industry insiders and many senior level people in the current administration have strong ties to the drug industry. (Related article: Vioxx recall shows that FDA has been hijacked by the drug industry)

Another startling fact that an average American does not know is that the FDA relies on the drug industry to tell the truth, which as the Vioxx case has shown, does not happen. There is tremendous incentive for drug industry to either cook up data or at least not share data that may be detrimental to its commercial interests. This loophole allowed Merck to keep the drug on the market (and kill tens of thousands of Americans) even though a lot of data was coming up that showed that Vioxx had serious complications.

Guerry Thornton, an attorney in Atlanta, will soon be lobbying Washington for new drug approval laws that do a better job of protecting American lives. "The system places too much emphasis on perceived benefits and not enough on the risks. The Vioxx review should have found that heart risks outweighed the drug's benefits. Surely 80,000+ deaths was too great a risk. The FDA relies on drug company safety data, and this needs to change," says Thornton.

"Certain Senators favor protection for FDA approved drugs. Such laws should not provide a safe haven for negligent drug companies," Thornton continues. What he is referring to are efforts by lawmakers to make it almost impossible for Americans to sue drug companies when they are injured by their products. We already have a very lenient drug approval process and if Congress passes law that makes drug companies not liable for their defective products, Americans will lose complete faith in the American drug approval system. The pharmaceutical industry, in a recent Gallup poll, was almost at the bottom of the list in approval by American people, in the company of oil and gas companies.

Related article: FDA favors Merck over American lives

Protect yourself from Vioxx scams and frauds

Several Vioxx victims have written to us in response to media reports that a huge industry of crooks is emerging trying to capitalize on the Vioxx recall scandal. Some analysts estimate that Merck's liabilities from Vioxx-related deaths and injuries plus losses suffered by shareholders could add up to $18 billion.

Websites and radio/TV/print media ads that promise that this is some kind of a gold rush are emerging all over. And many of these use highly unethical and deceptive practices to achieve higher search engine rankings. (Related article: Vioxx recall battle in cyber space)

Reasons why Vioxx recall is not an opportunity to get rich overnight

1. Merck is not giving any money away. On the other hand, Merck is putting a very strong fight. Like in any other lawsuit, you will need to convincingly prove in a court that you were hurt or a loved one was killed by Vioxx.
2. Merck is a large corporation with deep pockets and connections in high places, including the White House. It will use every tool in its arsenal to make it difficult for you to get a single dollar.
3. If you were on Vioxx but are not hurt at all, forget about receiving even a penny.
4. President Bush has made it a priority to deprive the American people of their right to sue corporations, particularly drug companies (that have contributed millions of dollars to the campaigns of Republicans who now control everything in Washington). In coming months, do not be surprised if your rights to sue Merck are totally gone or considerably limited. The administration might come up with other tactics to deny any compensation to you since it is payback time to the pharmaceutical industry.

Here are tips to protect yourself from scams and fraud related to Vioxx:

1. If someone is promising you something that sounds too good to be true, it probably is not true. Stay away from it.
2. Do not respond to SPAM. No decent law-firm will send SPAM since it is illegal to do so in the United States.
3. Be careful submitting your information on websites that look deceptive. Some signs of websites run by crooks are (i) No About Us section (ii) No mechanism to contact the owners of the website (iii) The website has information only about Vioxx and nothing else (iv) The website has just one page and appears to have been created "yesterday" (v) Rather than providing information that can help you, it is more interested in you submitting your information. If you are not sure, please contact us and we will be happy to help you.

For more help and tips, read our guide on how to find a Vioxx attorney.

Vioxx critic Topol and the scandal

Dr. Eric Topol, a prominent cardiologist and vocal critic of Merck's Vioxx strategy, is now being charged with conflict of interest by Fortune Magazine. Dr. Topol has written articles in medical journal accusing the FDA and Merck of not following proper procedures for testing and approving Vioxx, which resulted in the deaths of tens of thousands of Americans over the years.

Fortune Magazine is now reporting that Dr. Topol was advising a hedge fund that eventually shorted Merck stock (Explanations: An investor shorts a stock when she/he expects it to go down. A hedge fund is a group of investors that take very high level of risk and often invest billions of dollars.).

In our opinion, even a six-year old would have recommended shorting the Merck stock since the data was all over the place that Vioxx should have never been approved or at least should have been withdrawn as soon as problems started.

While Dr. Topol has presented solid arguments why Merck should have withdrawn Vioxx a long time ago, he should have also disclosed his affiliation with the hedge fund. He has been right all along but it would have been nice to know that he may have advised the hedge fund that Merck was a company with a lot of trouble ahead. But even an average person in the medical community knew that for years and the hedge fund would have shorted the stock any way, Topol's advice or not. We wonder if this is just another trick being played to discredit Dr. Topol.

Recommended article: Vioxx recall critic being harassed by FDA

Vioxx alternatives may not be totally safe

Recently released market share data reveals that after the recall of Vioxx, two drugs manufactured by the drug giant Pfizer have benefited a lot: Celebrex and Bextra. It is important to remember that these two drugs belong to the same family of drugs, as Vioxx, known by the technical name Cox-2 inhibitors. Pfizer Chief Medical Officer Joe Feczko has defended Pfizer's medicines, despite the fact that both drugs work by the same basic mechanism as Vioxx. Feczko emphasized that these drugs are different from Vioxx on a chemical level.

One lesson that every American can learn from the Vioxx recall scandal is that it is no longer a good idea to trust a drugmaker or the FDA or even your own doctor. You are basically on your own right now, since when things get ugly, no one is going to come and help you. On the other hand, Merck is aggressively defending its position, without admitting any guilt at all, even though it is well documented that Merck knew long ago that Vioxx could kill people.

So when you take either Celebrex and Bextra or anything else for pain relief, you also have to make your own decisions regarding the risk that you want to take. For instance, a preliminary study discussed at the American Heart Association's annual meeting indicated that Bextra more than doubled the risk of heart and stroke among heart disease patients taking the painkiller. Pfizer does not agree with the data completely but says that Bextra will have a serious warning that it can cause a potentially deadly skin reaction. The fact that Bextra, given with an injectable drug, increased the risk of heart attacks following open-heart surgery will also be included in the Bextra label.

Remember that statements made by Pfizer sound so similar to those made by Merck over the life of Merck. Merck never agreed to any data that was presented that questioned Vioxx. While it is likely that ongoing studies may very well prove that Pfizer is right, but till sufficient data is available, you should be cautious.

Recommended article: Review of alternatives to Vioxx for pain relief

Alternatives to Vioxx for pain relief

Several Vioxx victims have written to us asking about their options after the recall of Vioxx. Many are reporting that their doctors have already prescribed other drugs like Celebrex or Bextra. An important point to remember is that these pain-killers are not curing the underlying disease (for instance, arthritis) but are essentially allowing you not to experience pain. That task can be accomplished in many other ways (not all of them as effective as a drug like Vioxx or Celebrex or Bextra). Here are a few alternatives to look at:

Temporary pain relief

• How about trying some home-remedies? When heat or ice is applied to the area of the pain, you can experience a lot of relief when you have mild pain.
• Over-the-counter medications, particularly topical creams like Bengay, do a good job of relieving pain.

Change in lifestyle

• If you understand well the factors that reduce pain, you may want to consider making that change in lifestyle. For instance, many people experience lower levels of pain in a warm place. If you can relocate to a warmer place, even temporarily during the winter months, please try to consider it.
• Dietary supplements like glucosamine and chondroitin sulfate also help some people.

Over-the-counter pain-killers

• It is human nature to believe that expensive products provide better performance. But for pain relief, over-the-counter drugs like Advil, Aspirin, Aleve, etc. do a great job. And they are dirt cheap, particularly if you buy a large bottle at a discount store like Costco or BJ's.

Alternate therapies

• Many patients report relief from pain by starting yoga, acupuncture, exercising, mineral water spa treatments or some combination of these treatments.

Vioxx alternatives

• Of course, as doctors are already doing, you can choose to take Celebrex or Bextra, both of which somewhat comparable results.

Recommended link: Complete coverage of Vioxx recall