Vioxx recall controversy heats up in Canada

While the validity of FDA panel's recommendation to allow sales of Vioxx to resume in the US is in serious doubt due to conflicts of interest of panel members (10 panel members have financial ties to Merck and Pfizer), Merck is now getting into a row with Health Canada. (Related article: Merck and Pfizer ignored drug safety; focused on profits alone)

According to an interview published in The Globe and Mail, a leading Canadian newspaper, the Canadian Minister of Health Ujjal Dosanjh, has charged Merck of holding back safety data from drug regulators after it voluntarily recalled Vioxx worldwide in September 2004. “I can tell you that I am extremely concerned and disappointed with Merck [Frosst Canada] withholding data from Health Canada, even after it pulled the drug. I think they have an obligation and they have some explaining to do,” Ujjal Dosanjh said yesterday. (Related article: Merck could have found out Vioxx risks earlier)

The Health Minister has shown his frustration with Merck as the company failed to provide the data that was asked of them. It is clear from the interview that Merck dragged its feet on Vioxx safety data both prior to recall of Vioxx and subsequent to that. Health Canada representatives attended the FDA panel discussions in the United States last week. The agency issued an advisory on Cox-2 drugs in December 2004, and according to the transcript of an tele-conference published on its website, the Health Minister has promised to investigate the safety of these drugs. He calls the Cox-2 drug investigation as "one of the most demanding and costly that the department has undertaken in recent years in the area of post-market drug safety." (Related article: Merck knew of Vioxx risks, according to WSJ)

Ten Health Canada scientists and physicians are working full-time on the review of all Canadian and international studies, tests, trials, adverse effects reports, and other scientific evidence. Health Canada has been widely criticized for its poor performance in handling Vioxx recall process in Canada. (Related links: Louisiana Medicaid, Kaiser Permanente, New Zealand, European Union, and Australia limit/ban Cox-2 drug prescriptions) That was one major reason why the agency moved more aggressively in the case of Adderall XR recall despite the pressure by the FDA not to do so.

Merck Frosst, the Canadian operations of Merck, issued a statement today that the Company has at all times and will continue to cooperate with Health Canada in matters concerning Vioxx. "We are perplexed with the comments made to the Globe & Mail by Health Minister Ujjal Dosanjh" said Company spokesperson Marlene Gauthier. "The Company responded in writing to Health Canada's request for information and has offered to meet with Health Canada officials at their convenience. We had not received any verbal or written feedback to our letter until we saw the Minister's comments in the newspaper" she added.

Related developments

Merck shareholder lawsuits to be tried in New Jersey

Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra

Useful links

The Globe & Mail

Health Canada

Merck Frosst

Vioxx, Bextra decision in doubt due to conflicts of interests

Ten of the scientists who recommended that Vioxx sales be allowed to resume and Bextra continue to be sold in the United States all had financial ties to Merck and Pfizer, according to publicly available information analyzed by The Center for Science in the Public Interest and The New York Times. In other words, any reasonable person cannot expect them to be fair, though some of the panel members claimed that their ties to drugmakers did not influence their decisions. (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

In fact, had these ten members not been on the panel, the panel would have voted to ban both Vioxx and Bextra. In other words, FDA that has sided with Merck and Pfizer in the Cox-2 drug safety debate put together a panel so that it could make favorable recommendations. Prior to the panel hearings, FDA tried to stop Dr. David Graham and Professor Curt Furberg from attending these and gave in only after pressure from lawmakers. Both scientists had criticized the drugmakers and the FDA for mishandling of Vioxx recall. After the favorable vote from the panel, stocks of both Pfizer and Merck surged and some analysts are starting to speculate that the legal problems of the companies may be less of an issue going forward. (Related article: Merck and Pfizer ignored drug safety; focused on profits)

FDA helps Merck and Pfizer, even if it means risking American lives

• FDA has done everything in its power to help Merck and Pfizer so far. Cox-2 drugs, whose safety has not been studied yet, got fast-track approval. Then the agency failed to act after disclosures about deaths and injuries started to come in. It tried to silence its own expert, Dr. David Graham, who presented solid evidence that Vioxx should have never even been approved.
• Since the recall of Vioxx, Merck actually became even more aggressive in its stance and surprised many on Wall Street by refusing to make any provisions for its Vioxx liabilities which are estimated to be as high as $55 billion by some analysts. Now it is becoming clear that Merck must have known that FDA will come to its rescue. 140,000 Americans are estimated to have been injured by Vioxx and death estimates range from 30,000 to 50,000.
• Similarly, despite publication of research that highlighted risks of Celebrex and Bextra, Pfizer continued to stand by the safety of the drugs and refused to recall them. It too knew that FDA will put together a panel that will make favorable recommendations. (Related article: Pfizer may have known Celebrex risks)

The decision to recommend that Vioxx sales be allowed shocked most industry observers particularly because of the background of Vioxx recall. Merck voluntarily recalled the drug after it found that the drug was just not safe to be on the market. Then a series of studies released from October 2004 to middle of February highlighted that:

1. All Cox-2 drugs raise the risk of heart attacks and strokes.
2. These drugs do not provide any more benefit than an Aleve or Ibuprofen for almost all arthritis patients but cause serious side effects.
3. Merck and Pfizer fought Coke-Pepsi style over Vioxx, Celebrex, and Bextra.

It is no secret that FDA has become a dysfunctional agency due to its strong ties to the pharmaceutical industry. Not only does the pharmaceutical industry employs lobbyists to lobby the FDA, it is also one of the largest contributors of campaign funds (almost all go to the Republican Party).

Doctors and scientists often have unacceptable conflicts of interest

• It is also impossible to find many scientists and doctors in the United States that do not have ties to pharmaceutical firms. Since these folks are so desperate for research grants, they often rely on the drugmakers to fund these research projects.
• When researchers conduct research and if they come up with conclusions that could damage drug sales, the drug companies do not allow publication of the research or discussion of the results by the scientists.
• Until recently, researchers did not disclose conflicts of interests when publishing papers in medical journals.
• Doctors and scientists often get invited to all expenses paid trips, supposedly for education and technical discussions, but are in reality luxurious vacations for them, all paid for by drug companies. It is also common for doctors to be showered with gifts and giveaways from the drugmakers.

Related developments

Louisiana Medicaid restrictions for Celebrex and Bextra

New Zealand bans/restricts Cox-2 drugs

Australia limits/bans Cox-2 drug prescriptions

Merck could have found out Vioxx risks earlier

Merck shareholder lawsuits to be tried in New Jersey

The federal Judicial Panel on Multidistrict Litigation granted motions by several parties, including Merck, to transfer all Vioxx shareholder suits pending in federal courts nationwide into one consolidated Multidistrict Litigation (MDL) for coordinated pre-trial proceedings. It is important to understand that these lawsuits are different than those filed by arthritis patients who claim to have been injured by Vioxx. As previously reported, these Vioxx product liability cases are scheduled to be tried at the Eastern District Court of Louisiana before District Judge Eldon E. Fallon.

According to an estimate by AP, Merck is facing approximately 700 lawsuits from patients who claim that they have been seriously injured after taking Vioxx. In three days of hearings by a FDA panel, the decision was unanimous that Vioxx indeed raised the risk of heart attacks and strokes but the panel still recommended that Vioxx sales be allowed to resume in the United States. (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

Vioxx attorneys claim that total number of plaintiffs could run into tens of thousands, and a previous FDA estimate puts the number of Americans injured by Vioxx at 140,000. No accurate estimates are available for injuries outside the US but drug agencies in the European Union, Australia, Germany, and New Zealand have placed strong restrictions on prescriptions of Cox-2 drugs that are still on the market (Celebrex, Bextra, Arcoxia, Mobic, Dynastat, and their brand name variations).

Merck has announced its intention to market Vioxx again in consultation with the FDA in the United States. It is not known what will happen to Vioxx in other countries and how drug regulators in these countries will respond to FDA's decision to allow sales of Vioxx.

Merck shareholders have also filed lawsuits against the company in the Vioxx case claiming that Merck's handling of Vioxx recall has hurt its stock price. The shareholder cases, now designated as “MDL 1658-In re Merck & Co., Inc., Securities, Derivative & ‘ERISA’ Litigation,” include all federal securities, shareholder derivative and ERISA actions. Those cases are now being transferred to the United States District Court for New Jersey before District Judge Stanley Chesler, who will now set the schedule for pre-trial matters.

Merck is also facing lawsuits in other countries around the world. Analysts do not believe that resumption of Vioxx sales is likely to benefit Merck much. The company is also being investigated by the Department of Justice and Securities and Exchange Commission (SEC).

Related news today:

Louisiana Medicaid program restricts prescriptions of Celebrex and Bextra

Celebrex found to be safe for liver cirrhosis patients

Louisiana Medicaid restricts Celebrex, Bextra prescription

While the Ministry of Health in New Zealand has concluded that the risks of Cox-2 drugs like Vioxx, Celebrex, and Bextra outweigh their benefits, a FDA panel has recommended that despite such a high level of risks, these drugs should stay on the market with black-box warnings. This is a result of highly confusing research available at this time regarding the safety of these drugs and this poses several challenges to healthcare providers. For instance, Kaiser Permanente has banned Bextra till more data is available on its safety.

In a few weeks it will be known what decision the FDA takes but other decision-makers are trying to play it safe due to ongoing Vioxx, Bextra, and Celebrex litigation. In light of recent news reports that the pain-relieving drugs Celebrex and Bextra might increase risk for heart attacks and strokes, the Louisiana (United States) Department of Health and Hospitals is placing safeguards in the Medicaid Pharmacy Program to ensure these drugs are prescribed only with caution. (Related article: Vioxx sales may resume in the US)

Dr. Fred Cerise, secretary of the state Department of Health and Hospitals, will issue a letter to prescribing practitioners and pharmacists within the DHH Medicaid program March 1 informing them of the new policy regarding these drugs. The letter states that because of possible health risks associated with the use of Cox-2 inhibitors, effective March 15, Medicaid will fill these prescriptions only for recipients who demonstrate a medical need for these medications over an alternative pain reliever such as ibuprofen. The Louisiana Medicaid Drug Utilization Review Board, which provides direction on clinical appropriateness of medications to the Medicaid Pharmacy Program, suggested the state adopt this policy in light of recent reports about these possible adverse events. (Related article: European Union drug authority bans, restricts Cox-2 drugs)

“This is an aggressive, responsible approach to patient safety that will ensure better health outcomes for our Medicaid recipients,” Cerise said. “A ‘New England Journal of Medicine’ report showed our Medicaid recipients are prescribed these newer and more costly drugs at a higher rate than 46 other states,” said Medicaid Medical Director Dr. Roxane Townsend, who also provides consultation to the Drug Utilization Review Board. “This is often because of aggressive marketing for these drugs, not because of genuine medical needs for our patients. In many cases, an older and perhaps safer pain reliever would be just as effective and would not pose such a serious risk.” (Related article: Hundreds of millions of dollars spent on direct-to-consumer advertising for Vioxx, Celebrex, and Bextra by Merck and Pfizer)

Under the new prescribing policy, Medicaid patients could not have prescriptions for these drugs filled without the prescribing practitioner documenting medical justification for using Celebrex or Bextra instead of another pain reliever. Since Cox-2 inhibitors are meant to treat pain without causing damage to the stomach lining, patients with a history of stomach problems, or elderly patients at-risk for stomach problems, are the types of patients appropriately prescribed these medications. For those without such a history, a different medication would be prescribed in place of Celebrex or Bextra.

Such action by Louisiana may prompt other similar agencies and HMO's to place restrictions on prescription of Cox-2 drugs, particularly after overwhelming evidence that for vast majority of patients, Cox-2 drugs do not provide any additional benefits than Aleve does but could cause significant damage to the heart.

Recommended article: Merck and Pfizer fought a Coke-Pepsi style marketing battle over Vioxx, Celebrex, and Bextra

Useful links:

Louisiana Department of Health and Hospitals

Medicaid

New Zealand bans, restricts Cox-2 drugs

MedSafe, the Ministry of Health in New Zealand says the increased risk of heart attack and stroke (cardiovascular events) outweighs the benefits of COX-2 inhibitor drugs for the general population. This is in total contrast to the recommendations of the Food & Drug Administration (FDA) panel in the United States which found that despite the higher risks from Cox-2 inhibitor drugs, these should be left on the market. That means that Vioxx which was recalled in September 2004 due to safety concerns is likely to show up on pharmacy shelves in the US, though with a black box warning, and Celebrex and Bextra will also likely to be available, again with black-box warnings.

MedSafe is advising New Zealand nationals, who are at high risk of cardiovascular events, to see their doctor to discuss stopping treatment with COX-2 inhibitors immediately. Others taking the medicines, but not at high risk should discuss cessation of the COX-2 inhibitor at their next scheduled doctor's appointment and consider alternative treatment options. (Related article: Celebrex and Bextra have same risks as Vioxx, argues Merck)

"We don't have enough information yet to quantify the risk associated with each of the five Cox-2 inhibitors currently available in New Zealand," Ministry spokesman Dr Stewart Jessamine said. "But our preliminary conclusions are that all COX-2 inhibitors may increase the risk of developing a heart attack or stroke to some degree in some patients." New Zealand has more choices for arthritis patients than in the US and the Cox-2 drugs available there are Celecoxib (Celebrex), Etoricoxib (Arcoxia), Meloxicam (Mobic), Parecoxib (Dynastat), and Valdecoxib (Bextra). (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

Dr Jessamine said those at high risk were patients with a previous history of heart attack or stroke; a strong family history of heart disease; a history of diabetes, smoking, hypertension, or who are on treatment for high cholesterol. "Unfortunately despite reviewing extensive amounts of data, there is still not enough information to quantify the risk associated with each of these medicines, or to determine which patients are at increased risk or whether aspects of treatment such as dose or duration of use affect the degree of risk," Dr Jessamine said. (Related article: European Union authorities restrict/ban prescription of Cox-2 drugs)

Medsafe is seeking further information from the pharmaceutical industry and the published literature before making a final decision on the safety of these products. The Medicines Adverse Reactions Committee will discuss Medsafe's preliminary conclusions and any further data published or submitted on the safety of the COX-2 inhibitors at its March 2005 meeting. Any FDA or European regulatory agency findings made in the interim will also be considered at this meeting.

Recommended article: Pfizer claims Celebrex and Bextra safe drugs

Celebrex found to be safe for cirrhosis patients

Pfizer, the maker of celecoxib (or Celebrex), received some more good news from scientists on the safety of Celebrex for patients that suffer from cirrhosis of the liver. The study shows that Celebrex can be safely used for short periods of time in such patients. (Related article: Pfizer claims both Celebrex and Bextra are safe)

In the paper titled "Effects of celecoxib and naproxen on renal function in nonazotemic patients with cirrhosis and ascites," published in Hepatology Journal, the group of scientists Joan Clària, Jeffrey D. Kent, Marta López-Parra, Ginés Escolar, Luís Ruiz-del-Arbol, Pere Ginès, Wladimiro Jiménez, Boris Vucelic, and Vicente Arroyo compared Celebrex against naproxen (or Aleve) and placebo. They found that short-term prescription of Celebrex does not impair kidney function. Aleve, on the other hand, significantly inhibited platelet aggregation. (Related article: Aleve cardiovascular safety affirmed by FDA panel)

Readers may recall that while Celebrex has been found to have adverse side effects on the heart but in the COX-2 inhibitor drugs category, Celebrex was perceived as a relatively safer drug, according to the FDA panel that recently reviewed the available science in three days of hearings. While the panel recommended that Celebrex be allowed to stay on the market with a black box warning, this study is another indication that Cox-2 drugs like Vioxx, Celebrex, and Bextra do have small benefits for patients with very specific problems. (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

The Cox-2 inhibitor drugs block the Cox-2 enzyme in the body and scientists speculate that it is the main reason this class of drugs affects the heart through the changes it produces to substances involved in the initial stages of blood clotting and the body's response to blood clots. But this study shows that this same mechanism apparently helps people with liver problems.

Celebrex is not totally out of the woods yet. MedSafe, the Ministry of Health in New Zealand, has essentially banned all Cox-2 drugs including Celebrex, Bextra, Dynastat, Arcoxia, and Mobic. Similar steps have already been taken in the European Union and Australia.

The study was funded by the Spanish Ministry of Science and Technology (Ministerio de Ciencia y Tecnología), Instituto de Salud Carlos III, and Pfizer/Pharmacia.

Recommended article: Vioxx sales may resume in the US


Useful links:
Hepatology
Ministerio de Ciencia y Tecnología
Instituto de Salud Carlos III
Medsafe

Aleve safety affirmed by FDA panel

When Vioxx was recalled in September 2004, almost all drugs in the Cox-2 inhibitor drugs category came under scrutiny. Then came a series of studies on Celebrex and Bextra that highlighted some of the risks of these drugs, causing even more confusion. As readers may recall, a FDA panel has recently recommended that Vioxx sales may resume with a black-box warning and Pfizer allowed to keep both Celebrex and Bextra on the market, though with black-box warning on Celebrex (Bextra already carries a black-box warning). (Related article: Making sense of FDA panel recommendations on Vioxx, Celebrex, and Bextra)

Another drug that got caught in the confusion is naproxen (marketed as Aleve in the United States). Other common brand name is Naprosyn. In a study by the National Institute of Health and FDA, it was found that Aleve was responsible for an apparent increase in heart problems. While the FDA issued an advisory at that time, it was primarily a precautionary step.

During the discussions held last week, Arthritis and Drug Safety and Risk Management Advisory Committees clarified conflicting reports about the safety of Aleve that have confused and, in some instances, alarmed consumers and healthcare professionals. The discussion at the Meeting of the Advisory Committees affirmed the safety of Aleve and distinguished the safety profile of naproxen, the active ingredient in Aleve, from selective COX-2 inhibitors and other non-selective nonsteroidal anti-inflammatory drugs (NSAIDs), based on the weight of clinical data presented at the meeting. Some members of the panel even suggested that naproxen should be the standard by which future pain relievers should be measured for cardiovascular safety. (Related article: Analysis of FDA panel's recommendations with regards to Vioxx, Celebrex, and Bextra)

The presentations and discussions before the Committees also clarified that the widely publicized suspension of the Alzheimer’s Disease Anti-Inflammatory Prevention Trial (ADAPT) on December 20, 2004 was precipitated not by Aleve safety concerns, but rather by administrative and practical issues.

Recommended article: European drug regulators ban, limit Cox-2 drugs

Making sense of recommendations on Vioxx, Celebrex, Bextra

The hearings of the FDA panel, while coming up with some shocking recommendations, also caused a lot of confusion. On one hand, expert after expert has argued for years that Vioxx, Celebrex, and Bextra are such dangerous drugs that they should have never been approved or recalled much earlier. On the other hand, the panel recommended that all three drugs are safe for marketing, despite their huge risks, provided a black-box warning is added. (Related article: Implications of FDA panel's recommendations on Vioxx, Celebrex, and Bextra)

So what should an arthritis patient make of it? There is plenty of research out there on all three drugs but nothing that provides a definitive answer either way. No wonder the panel members have called for more research, ban on direct-to-consumer advertising, and severe restrictions on prescriptions. (Related article: European authorities ban/restrict Cox-2 drugs)

So how will FDA respond to the recommendations? No one knows. In most cases, FDA simply accepts the advice of advisory panels though it can come up with a different decision in the case of Vioxx where the vote was a close one. If the requirement was a two-thirds or three-fourths vote, Vioxx would not have been allowed back on the market. Since the recall of Vioxx, FDA has come under strong criticism from all quarters, including politicians in Washington that generally do not criticize the FDA or the pharmaceutical companies (that are among the largest contributors to Republican lawmakers). So it would not be a surprise if FDA did reverse the panel's recommendations in the case of Vioxx, but that would pose a lot of problems for the agency considering that Merck has taken a very aggressive approach since the recall of Vioxx in September 2004. (Related article: Merck knew of Vioxx risks earlier)

While investors have generally cheered the recommendations of the panel, the analysts are still very cautious. Readers of this website may recall the Sanford Bernstein analyst, Richard Evans' estimate of Merck's Vioxx liabilities to be as high as $55 billion if Vioxx plaintiffs could prove negligence. Evans is not changing his opinion despite what is generally perceived as positive news for Merck. "Even if Vioxx returns, we don't see a change in product liability," he said in a research report. "Plaintiffs have to show two things: that they were harmed by the product and that the manufacturer failed to warn." And it is pretty obvious that Merck did fail to warn and might have even hidden damaging information about Vioxx from consumers and doctors.

By admitting that Vioxx and other drugs in the Cox-2 class like Celebrex and Bextra have similar side effects, Merck is simply trying to say that it was not the sole culprit in the crime. Indeed it makes Merck's position no better than before the panel's recommendation, but it does make the case of Vioxx victims stronger. And also, makes Pfizer subject to more lawsuits from Celebrex and Bextra patients. (Related article: Merck and Pfizer ignored drug safety; focused on profits)

Recommended article: Celebrex and Bextra to stay on market with stronger warnings

Implication of FDA decision on Vioxx, Celebrex, Bextra

The latest news that Vioxx sales may resume in the United States and that Celebrex and Bextra can stay on the market with black box warning may sound like good news for Merck and Pfizer but it has shocked and confused a lot of people. At first instance, this decision by the FDA panel seems heartless and callous. How could any scientist vote for keeping a drug on the market when according to the FDA, 140,000 Americans have been injured by Vioxx alone? And in another estimate by Public Citizen, 100,000 deaths and 2.1 million serious injuries a year result from adverse reactions due to Celebrex and Bextra.

So let us analyze what has really happened here and how it will impact the those injured and family members of those deceased after taking any of these three drugs. We are also hopefully answering all the emails that we have received from our readers.

What did the FDA panel really say?

• All three drugs in the Cox-2 class, that is, Vioxx, Celebrex and Bextra have serious side effects, particularly on the heart. In other words, the panel said today what Merck or Pfizer never told the patients. A drugmaker should disclose every single piece of information that it knows about the drug. Both Merck and Pfizer failed in their duties to inform doctors and patients, and instead, fought Coke-Pepsi style marketing battles. (Related article: Merck and Pfizer fought Coke-Pepsi style marketing battles)
• Just because the drugs may be sold does not mean that they are as safe as they were made out to be by Merck and Pfizer in their direct-to-consumer advertisements for Vioxx, Celebrex, and Bextra. What the scientific community has said is that these drugs do have benefits as well as risks and as long as patients and doctors understand both they can jointly decide what is best for them. (Related article: European Medicines Agency also leaves Vioxx, Celebrex, and Bextra on the market but with strong warning and restrictions)
• Doctors understand that there is simply no drug without side effects. Doctors like to have more choices so that they can determine what is best for their patients.

How does it impact patients of Vioxx, Celebrex, and Bextra?

• Actually there is plenty of research that came out during the panel hearings that validates what arthritis patients (and family members of those who died due to any of these drugs) have known for a while - that these drugs injured them. If these people would have known what came out in three days of hearings, they would have either not taken these drugs or taken them knowing what the risks are. (Related article: Vioxx doubled heart risks, study finds)
• Merck and Pfizer are still liable for any injuries that their drugs caused. The fact that the panel agreed today that these drugs do increase possibility of heart attacks and strokes makes their case more solid. Having these drugs on the market changes nothing insofar as Vioxx litigation is concerned.
• While Merck will argue that Vioxx alone is not the culprit and try to drag Pfizer into the legal mess, it does not change the fact that Merck made a product that injured Americans and people all over the world.

Recommended article: Merck knew of Vioxx side effects

Vioxx sales may resume in the United States

Vioxx may be back soon in drugstores in the United States. According to the recommendation of the FDA panel, while Vioxx does increase the risk of heart attacks and stroke, it is safe enough to be sold in the United States. (Related article: Celebrex and Bextra have same risks as Vioxx, argued Merck)

Earlier the panel also voted to let Celebrex and Bextra remain on the market with black box warnings.

Vioxx was recalled voluntarily by Merck in September 2004 when it was found that Vioxx doubled the risk of heart attacks. Since then, Merck has been a target of hundreds of class action lawsuits that are scheduled to be tried in Louisiana.

The panel's advice is non-binding on the FDA but in most cases FDA follows the advice. It is expected that FDA will come up with a final decision on resuming sales of Vioxx within a matter of weeks. (Related article: FDA scientist argued that Vioxx should have never even been approved)

According to FDA's estimates as many as 140,000 Americans have been injured by Vioxx. Many consumer rights groups and doctors have demanded that the FDA ban the drug along with other Cox-2 drugs like Celebrex and Bextra. However, doctors would have been left with fewer choices of painkillers if all Cox-2 drugs were banned.

In summary, it means that all Cox-2 drugs will stay on the market in the United States simply because they are all dangerous to varying degrees. (Related article: Europe restricts, bans Cox-2 drugs)

The vote on Vioxx was very close with 17 members voting in favor of bringing it back on the market and 15 opposing the decision.

What does it mean for 140,000 Americans injured by Vioxx?

According to preliminary analysis, the decision has only minimal change on Vioxx litigation if they were actually hurt by the drug. The decision does help Merck to some extent since it will now start to receive revenue from Vioxx once again.

Recommended article: Australia limits or bans prescription of Cox-2 drugs

Celebrex, Bextra to stay with strong warning

The FDA panel that has been reviewing Cox-2 drugs like Vioxx, Celebrex, and Bextra unanimously agreed moments ago that both Celebrex and Bextra do cause heart problems in many patients. In other words, it did not agree with Pfizer's assertions that Celebrex and Bextra are safe drugs. However, the panel found that the drug do have some benefits, and therefore, there is no need to recall either Celebrex or Bextra at this time. (Related article: Pfizer may have not disclosed all Celebrex risks)

The panel has, however, recommended that Celebrex carry the strictest form of warning, highlighted in a black box, on the label. Pfizer's other drug, Bextra, also carries a black box warning. A black-box warning is a way to tell doctors and patients that the drug has risks and should be prescribed when there is no other alternative.

The European Medicines Agency (EMEA) and (Australian) Therapeutic Goods Administration came up with similar recommendations on Celebrex and Bextra.

Celebrex is a blockbuster drug for Pfizer and a lot of patients like it even though many studies have shown that the drug is no better than an over-the-counter painkiller. Many of these patients still pleaded with the FDA to leave the drug on the market. (Related article: Merck wants to sell Vioxx again)

Celebrex belongs to the Cox-2 class of drugs that are also called lifestyle drugs, meaning that they do not cure a disease but provide relief from a suffering. With very aggressive direct-to-consumer advertising, Pfizer convinced millions of Americans to take Celebrex. However, sales drop rapidly after the heart risks were disclosed in a series of studies in December 2004 and during January and February this year. (Related article: Pfizer warned by FDA for misleading Celebrex, Bextra advertisements)

Recommended article: FDA expert blasts Merck, Pfizer, and Cox-2 drugs

Europe restricts, bans Cox-2 drugs

The European Medicines Agency (EMEA), the regulatory body responsible for drug regulation in all European Union countries (a role similar to that of the FDA in the United States), has announced a number of regulatory actions for the COX-2 inhibitor class of medicines following discussions at the 14-17 February 2005 meeting of the Committee for Medicinal Products for Human Use (CHMP). This news comes at the same time that Merck intends to start selling Vioxx again. (Related article: Merck, Pfizer ignored drug safety; focused on profits alone)

The CHMP concluded that the available data show an increased risk of cardiovascular adverse events for COX-2 inhibitors as a class. The data also suggest an association between duration and dose of intake and the probability of suffering a cardiovascular event. These findings are very similar to those of the Therapeutic Goods Administration (TGA) in Australia that has also banned/limited prescription of Cox-2 drugs. This class of drugs includes Vioxx, Celebrex, Bextra, Arcoxia, Prexige, and variations of their brand names all over the globe. (Related article: Celebrex and Bextra have same risks as Vioxx, argues Merck)

The following urgent safety restrictions have been taken for COX-2 inhibitors available in the European Union:

1. A contra-indication (meaning that the drug should not be taken) is introduced for all COX-2 inhibitors in patients with ischaemic heart disease (not enough blood to the heart) or stroke.
2. As a further measure, a contra-indication is introduced for etoricoxib (Arcoxia) in patients with hypertension (high blood pressure) whose blood pressure is not under control.
3. A warning is introduced for prescribers to exercise caution when prescribing COX-2 inhibitors for patients with risk factors for heart disease, such as hypertension, hyperlipidaemia (high cholesterol levels), diabetes and smoking, as well as for patients with peripheral arterial disease.

Given the association between cardiovascular risk and exposure to COX-2 inhibitors, doctors are advised to use the lowest effective dose for the shortest possible duration of treatment
These are interim measures pending the finalization of the class review, expected in April 2005.

The Committee also concluded that more research is needed in the field to evaluate the cardiovascular safety of COX-2 inhibitors, and that ongoing cardiovascular trials should continue as planned. Companies like Merck, Pfizer, and Novartis had provided EMEA with information on their drugs. All drugmakers of Cox-2 inhibitor drugs have argued that their drugs are safe. They have made similar arguments to the ongoing FDA advisory committee meeting in the United States. (Related article: Pfizer claims Celebrex, Bextra safe drugs)

It is important to understand the position of Pfizer which has argued that there is no class effect, or in other words, Celebrex and Bextra are different from Vioxx despite having the same working mechanism. Merck, on the other hand, is arguing that if there is a problem with Vioxx, then it must be extended to other Cox-2 drugs like Celebrx and Bextra. It is very likely that Merck may be putting this argument forward merely for competitive reasons. (Related article: Merck and Pfizer fought Coke-Pepsi style marketing battle over Vioxx, Celebrex, and Bextra)

The review of COX-2 inhibitors by the European Medicines Agency began in October 2004 at the request of the European Commission. Hearings were held with the Marketing Authorisation Holders on 18 January and 15 February 2005. The whole process is not complete yet and these are merely interim decisions. The FDA will conclude its meeting today and then decide its course of action within a few weeks. (Related article: FDA tries to protect Merck and Pfizer)

This decision by EMEA stops short of banning the whole class of Cox-2 drugs. While both Celebrex and Bextra will continue to be sold in Europe, their prescriptions will be highly limited. But EMEA has specifically banned the use of Arcoxia among patients with high blood pressure.

The decision by EMEA is based on the same argument that world-famous FDA scientist Dr. David Graham has made. His research has shown that there is a class effect and there is simply no need for Cox-2 drugs on the market. (Related article: Dr. David Graham blasts Merck, Pfizer, FDA, and Cox-2 drugs)

Recommended article: Vioxx class action lawsuits to go ahead in Louisiana

Merck wants to sell Vioxx again

Merck is planning to bring Vioxx back on the market after voluntarily recalling it in September 2004 after a study showed that Vioxx doubled the risk of heart attacks. This announcement was made by a Merck scientist during the ongoing advisory committee meeting organized by the FDA. According to estimates by the FDA, as many as 140,000 Americans have since been seriously injured by Vioxx and there is enormous amount of evidence about the deadly effects of Vioxx. (Related article: Celebrex and Bextra have same risks as Vioxx, argues Merck)

This announcement has not shocked many Vioxx patients and family members of those killed by Vioxx since Merck has shown no remorse so far for keeping a dangerous drug on the market for so long. Research has also shown that for Merck, profits were more important than human lives. The firm continues to deny that Vioxx was responsible in any way for deaths and injuries. (Related article: Merck and Pfizer ignored drug safety; focused on profits)

Since the recall of Vioxx, hundreds of lawsuits have been filed against the firm and Vioxx attorneys estimate that the final count of plaintiffs will run into tens of thousands in the United States alone. Merck has admitted no guilt and has vowed to vigorously fight each lawsuit. During the four month period since the recall of Vioxx, several studies have shown that not only does Vioxx has serious side effects, especially among the elderly arthritis patients, Merck knew all along how dangerous the drug was. (Related article: Merck could have found out Vioxx risks earlier)

Critics and consumer rights group charge that Merck engaged in a program designed to dodge any safety questions related to the drug. In the hearings on Thursday, Dr. David Graham, the FDA expert argued that not only Vioxx but other Cox-2 drugs are equally dangerous and should not be on the market simply because they provide no benefits to patients. (Related article: Pfizer also claimed that Celebrex and Bextra are safe drugs)

It is early to assess the impact of this announcement by Merck since the FDA could still ban Merck from selling Vioxx. Since the recall of drug, Merck has pretended as if nothing has happened and has not allocated even a penny for its Vioxx liabilities that are expected to be as much as $55 billion. Some analysts predict that Merck will either be acquired or file for bankruptcy. Today's announcement may be just a desperate attempt by Merck to influence panel members. (Related article: Merck vows to defend itself after federal judges consolidate all Vioxx class action lawsuits for trial in Louisiana)

Several patients pleaded with the panel that some Cox-2 drugs should be on the market despite assertion by many scientists that these drugs did nothing more than what an Aspirin does but have far worse side effects.

Recommended article: Merck and Pfizer fought Coke-Pepsi style marketing battle over Vioxx, Celebrex, and Bextra

David Graham blasts Merck, Pfizer, FDA & Cox-2 drugs

Highly respected FDA scientist Dr. David Graham, who is being harassed by his superiors at the agency and was barred from presenting his research was finally allowed to do so after intervention by Senator Grassley, has essentially argued very convincingly that there is no real value in having Cox-2 drugs like Vioxx (since recalled), Celebrex, and Bextra on the market.

Dr. Graham, with Yale Medical School and John Hopkins on his resume, has made himself highly unpopular among pharmaceutical firms like Merck and Pfizer and their cronies inside the FDA by exposing the cozy relationship between the drug companies, the politicians in Washington, and the top brass at the FDA. It is common knowledge that not only did Merck and Pfizer knew that Cox-2 drugs had serious side effects on the heart, even the FDA did nothing to stop the injuries, that are now estimated to be at least 140,000 in the United States alone. (Related article: Merck and Pfizer ignored drug safety; focused on profits)

The only area in which Dr. Graham agrees with Merck is that the problem is not with Vioxx alone. Other drugs like Celebrex, Bextra, Prexige, and Arcoxia have the same problem, as argued by Merck. He did say, however, that Celebrex and Bextra in smaller doses do not pose as much risk as Vioxx does. (Related article: Pfizer still claims that Celebrex, Bextra safe)

A few other findings that Dr. Graham presented:

• Vioxx is so dangerous that it can cause harm immediately, not after a year and half as Merck has claimed. (Related article: Vioxx doubled heart risk, study finds)
• Naproxen (sold as Aleve) is no good alternative to Vioxx, Celebrex, and Bextra.
• Painkiller Mobic, which has become quite popular since the Vioxx recall, also showed an "increased risk" for heart attacks in preliminary data. (Related article: Use of Mobic restricted outside the US)

It is important to remember that both Merck and Pfizer received approvals for their Cox-2 drugs using a fast-track process. That process allows the drug companies to not study long-term side effects of drugs prior to their approval. This puts the patients at risk since they are taking drugs for which enough information is not available. The problem got even worse in the case of Vioxx and Celebrex because these drugs were marketed like consumer products when many doctors knew that they were only just as good as an Aspirin for pain relief though had serious side effects on the heart. (Related article: Merck and Pfizer fought Coke-Pepsi style marketing battle over Vioxx, Celebrex, and Bextra)

Dr. Graham has argued that Vioxx should have never been approved. He criticized the drug approval process that allows drug companies to not conduct long-term trials. He also implied that the FDA was not doing its job of protecting the health of American people.

Other related developments:

Vioxx class action law suits to be tried in Louisiana

FDA tries to protect Merck and Pfizer

Australia limits/bans use of Cox-2 drugs

Celebrex attorneys seeking plaintiffs

Pfizer claims Celebrex, Bextra safe drugs

As reported earlier, the Coke-Pepsi style marketing battle between Merck and Pfizer is not over yet. The two companies showed elements of their bitter relationship at the ongoing meeting at the FDA to evaluate if Celebrex and Bextra should be recalled. Pfizer once again reaffirmed the safety of its drugs Celebrex and Bextra. (Related article: Merck and Pfizer ignored drug safety; focused on profits)

While Merck argued that the adverse side effects of Vioxx should be present in all other drugs in the Cox-2 inhibitor drugs class, Pfizer disagreed, as it has all along. While all Cox-2 drugs work using the same principle, Pfizer has argued since the recall of Vioxx that its drugs Celebrex and Bextra are different at molecular level. Not all experts agree with Pfizer's assertions though. A series of studies released during last two months have shown that even Pfizer and Bextra have serious side effects for arthritis patients, particularly the elderly. (Related article: Latest update on Celebrex, Bextra, Arcoxia, and Prexige)

FDA medical officer James Witter put the skepticism of scientists in a few words, but very eloquently, "The absence of evidence is not evidence of absence. There is still more we need to know (about Celebrex and Bextra)". (Related article: Bextra banned by Kaiser Permanente)

Pfizer presented an analysis of 41 studies comparing Celebrex to older nonsteroidal anti-inflammatory drugs (NSAIDs) including naproxen (Aleve) and ibuprofen. The studies show that the risk of heart attacks with Celebrex is "consistently similar" to that seen with NSAIDs or even no painkiller use. Pfizer's analysis, however, only presented data comparing Celebrex to older drugs and not to a placebo. Placebo comparisons are important to fully understand the risks of a drug. (Related article: Pfizer may have hid Celebrex side effects)

Pfizer has also not provided any additional information on Bextra arguing that the drug is very similar to Celebrex. The company is also submitting only its own research and has not provided any independent research in support of its arguments about the safety of Celebrex and Bextra. (Related article: Pfizer's position on safety of Celebrex)

From Wednesday's hearings it is not apparent what the outcome will be. There are many opinions. Consumer groups and many scientists have called for a recall of Celebrex and Bextra till their risk profiles are better studied. Other doctors are suggesting that the drugs be left on the market but with a stronger warning so that these drugs are used only in very special cases, not like they were used prior to recall of Vioxx when these drugs were basically marketed as consumer products. (Related article: Aggressive direct to consumer advertising by Merck and Pfizer)

Attorneys preparing for Vioxx and Celebrex related lawsuits are also watching the hearings carefully since any thing that the drug companies say in these hearings can be used against them. That has made the discussions somewhat dull since all scientific details are not coming out. Another major problem with the hearings is the missing data from world-renowned expert Dr. David Graham. Since his research contradicts FDA's position and shows that FDA did not do its job, he has been prohibited by the agency from presenting his controversial findings. He continues to be mistreated by his superiors within the agency and despite intervention by Senator Grassley, he is unable to share his findings.

Recommended article: Safety of Celebrex and Bextra questioned by European Medicines Agency

Merck, Pfizer ignored drug safety; focused on profits

Since the recall of Vioxx, several experts have argued that Vioxx and other Cox-2 drugs like Celebrex and Bextra were just glorified Aspirins that became blockbuster drugs merely because of slick direct-to-consumer advertising by Merck and Pfizer. They were more often marketed to people who did not need them and would derive the least benefit, and were priced several times more than what an over-the-counter painkiller like Aleve or Ibuprofen costs. And that's not all. The side effects of all of these drugs were much worse than what Merck and Pfizer disclosed. (Related articles: Pfizer may have hid Celebrex side effects and Merck could have found out Vioxx risks earlier)

It has since been reported that Merck and Pfizer engaged in a Coke-Pepsi style marketing battle flooding the airwaves with direct-to-consumer advertisements. After the recall of Vioxx, Pfizer was warned by the FDA for misleading Celebrex and Bextra ads. As Merck and Pfizer misled both arthritis patients and doctors, Merck was busy training its sales reps to dodge questions from doctors about the safety of Vioxx.

The FDA in the meantime was more busy trying to build a case why Americans should not be allowed to import prescription drugs from Canada so that it could help its friends in the pharmaceutical industry. No wonder drug safety took a back seat, resulting in as many as 140,000 Americans being injured by Vioxx alone.

Published studies of prescription painkillers Vioxx, Celebrex, and Bextra were largely geared to developing new uses for those drugs and were much less concerned with the question of whether they increased users' risk of heart attacks and strokes, according to a review of the medical literature by the Center for Science in the Public Interest (CSPI). (Related article: Arthritis patients misled by Merck advertising)

That patients taking COX-2 inhibitors might be at greater risk of experiencing cardiovascular events became known in the medical community in 2001, when researchers from the Cleveland Clinic published a warning in the Journal of the American Medical Association. Yet even after that report, none of the clinical trials published in the medical literature was designed to gauge that risk. And while CSPI found that many of the studies were funded by the drug companies themselves, even the independently funded trials failed to assess the overall cardiovascular impact of this class of drugs. (Related article: Vioxx doubled risk of heart attacks, study finds)

CSPI could determine the source of funding for 145 out of 237 published clinical trials of those drugs, known as COX-2 inhibitors. And of those 145, 103 were funded directly or indirectly by Merck and Pfizer, the companies behind the drugs, and 41 were funded by government or non-profit institutions.

Nearly 85 percent (87 of 103) of the industry-funded trials that have appeared in the academic literature since 2001 involved testing the pain relief afforded by COX-2 inhibitors for off-label uses, according to CSPI. Just 16 (15.5 percent) of the trials funded by drug companies evaluated any type of health risk associated with the drugs, and only five (4.9 percent) of those had anything to do with cardiovascular risk. Three of those were funded by Pfizer, and sought only to measure narrow questions such as those involving drug-drug interactions among cardiovascular patients. (Related article: History of Vioxx and its recall by Merck)

When research is funded by a company, it can refuse permission of publication of the findings for any reason whatsoever. In one specific case, Merck forced one of its scientists to withdraw her name from a published paper when the results showed a correlation between Vioxx and heart attacks.

"Drug companies are effusive in their self-congratulation over their big research and development budgets, but they tend to spend that money figuring out how to sell more drugs instead of answering these critical safety questions," according to Merrill Goozner, director of the Integrity in Science project at the CSPI. "The idea is to get results published in a wide range of journals so that salespersons can deliver reprints to physicians in those specialties."

Merck, for instance, funded 12 physicians associated with the Altoona Center for Clinical Research to test Vioxx against a traditional non-steroidal anti-inflammatory drug made by one of its rivals for arthritis of the knee. The results, published last year in the Journal of the American Geriatric Society, showed both worked, both were well tolerated and Vioxx offered slightly faster pain relief.

CSPI's review comes as the Food and Drug Administration is holding a three-day hearing to evaluate the magnitude of the cardiovascular risk posed by Vioxx and other COX-2 inhibitors. Its findings quantify problems finally being recognized by leading voices in the medical community. Merck has argued at the hearings that Vioxx alone is not the problem in the Cox-2 drugs class. Even Celebrex and Bextra are equally dangerous.

In the meantime, Merck has a lot of explaining to do in the courts. Hundreds of class action lawsuits have been filed against Merck and these will now be heard in Louisiana.

Recommended article: Celebrex attorneys plan to sue Pfizer

Vioxx class action lawsuits to be tried in Louisiana

A panel of federal judges has issued an order assigning a Louisiana judge to hear all pre-trial matters in federal lawsuits alleging damages caused by the now-withdrawn arthritis drug Vioxx, HarrisMartin Publishing is reporting. (Related article: Celebrex attorneys prepare for class action lawsuits against Pfizer)

In the meantime, in ongoing hearings at the FDA, Merck is arguing that Celebrex and Bextra are as dangerous as Vioxx since they all belong to same Cox-2 inhibitor drugs class.

The product liability cases, now designated as "MDL 1657-In re VIOXX Product Liability Litigation," include all federal cases involving personal injury or economic losses arising from the use and/or purchases of Vioxx. This is not the court that Merck had wanted. The company was seeking a more conservative business-friendly court. This choice by the federal judges is likely to help Vioxx plaintiffs. (Related article: Vioxx attorneys soothe nerves of victims threatened by Merck's aggressive approach)

In a statement released by Merck, the company said that it intends to vigorously defend itself. "Merck acted responsibly every step of the way - from researching the drug prior to approval - to monitoring the drug while it was on the market and - to voluntarily withdrawing the drug when it did. Merck based its decisions on the data from well controlled clinical trials and acted in the best interest of patients," the company said in a written statement. (Related article: Tough Vioxx litigation expected)

Since the recall of Vioxx in September 2004, the company is facing hundreds of lawsuits from tens of thousands of plaintiffs. Merck is also being investigated by the Securities and Exchange commission (SEC), the Department of Justice (DOJ), and Congressional committees. State of New York has also sued Merck. Plaintiffs in other countries are also suing Merck and there is speculation that Merck may be forced into bankruptcy due to an estimated $38-55 billion in Vioxx liabilities.

Pre-trial activity for all Vioxx claims filed in federal courts throughout the country will be overseen by Judge Eldon E. Fallon in the U.S. District Court for the Eastern District of Louisiana.

The Judicial Panel on Multi-District Litigation (JPML) issued the official transfer and consolidation order today from its headquarters in Washington, D.C., a little more than three weeks after a panel of seven federal judges held a hearing on the matter in Ft. Myers, Fla.

Last October, plaintiffs in a Vioxx personal injury case brought in the Eastern District of Louisiana were the first to file a motion to create a Vioxx multi-district litigation docket, or MDL. Merck, which voluntarily withdrew the drug from worldwide markets on Sept. 30, 2004, also filed consolidation motions in numerous cases pending in federal courts. (Related article: Litigators prepare for Vioxx class action lawsuits)

During a hearing held Jan. 27 in Ft. Myers, attorneys representing plaintiffs in several of the more than 600 federal lawsuits that have been filed since the Vioxx withdrawal, argued that the cases should be transferred and consolidated before a single judge in Louisiana, Indiana, Texas, Illinois, New Jersey, California, Pennsylvania or Oklahoma, among other locations. Merck recommended that the panel consolidate the Vioxx claims in the District Court of Maryland, or federal courts in Indiana, Pennsylvania or Illinois. (Related article: Merck's aggressive approach to Vioxx lawsuits)

Merck is also a defendant in many class action lawsuits alleging violations of securities laws. The company said that it is still awaiting a decision from the panel with respect to the shareholder suits, designated as "MDL 1658-In re Merck & Co., Inc., Securities, Derivative & 'ERISA' Litigation."

Recommended article: Vioxx litigation update provided by Merck

Celebrex, Bextra have same risks, argues Merck

In ongoing testimony at the meeting organized by the FDA, Merck is essentially arguing that Pfizer's claims of safety of drugs like Celebrex and Bextra are not valid. (Related article: Pfizer reaffirms Celebrex safety) Pfizer has all along argued that despite both drugs being members of the same Cox-2 inhibitor drugs class, Celebrex and Bextra have different molecular structures; and hence, they are different and safe. Or in other words, both Bextra and Celebrex need not be recalled. (Related article: Australia limits or bans Cox-2 drugs)

Research released yesterday by the New England Journal of Medicine suggested the entire class of Cox-2 medicines may pose some level of risk to patients' hearts. Several other studies released since the recall of Vioxx have highlighted varying degrees of risks with Celebrex and Bextra. Many scientists think that over-the-counter painkillers are fine for most arthritis patients though drugs like Aleve can also cause damage if taken over extended periods of time. The FDA is only reviewing drugs belonging to the Cox-2 category and that also included drugs like Arcoxia and Prexige which are not yet approved in the United States. There is no discussion planned to consider a recall of drugs like Aleve. (Related article: Celebrex attorneys have already started to seek plaintiffs for class action lawsuits against Pfizer)

In the meantime, the New England Journal of Medicine has published three studies that show that the whole class of Cox-2 drugs has serious adverse side effects.

1. Dr. Robert Bresalier of the University of Texas M.D. Anderson Cancer Center found that Vioxx almost doubled the risk of heart attacks, strokes and other major adverse events.
2. Dr. Scott Solomon and fellow scientists at Brigham and Women's Hospital and Harvard Medical School found that Celebrex doubled or even tripled deaths from heart attack, stroke or heart failure, depending on the dose. (Related article: Pfizer's position on safety of Celebrex)
3. Dr. Nancy Nussmeier of the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston and her colleagues studied Bextra in heart surgery patients. They found that 7.4 percent of those given the drugs had an adverse event -- such as heart attacks, kidney failure, ulcers and complications of wound healing -- compared with 4 percent of those given placebo alone.

Dr. Jeffrey M. Drazen writing an editorial in the New England Journal of Medicine, which released the three studies above ahead of time due to their implications on the ongoing hearings, says that a substantial number of deaths could have been prevented if the FDA, Merck and Pfizer had focused on understanding the risks. On the other hand, both Merck and Pfizer fought a Coke-Pepsi style marketing battle. Dr. Drazen reminds his fellow scientists, "As we apply new science to develop new medicines, we must not forget that our first job is to do no harm." Sadly enough, that is exactly what Merck and Pfizer scientists did not do. A lot of evidence has since emerged that dangers of Vioxx were known years ago and both FDA and Merck simply shut their eyes. (Related articles: 140,000 Americans injured by Vioxx alone and FDA tries to protect Merck and Pfizer)

Dr. Bruce Psaty and Dr Curt Furberg argue that Cox-2 drugs were never any better than Aleve or Aspirin. "In clinical trials, NSAIDs, aspirin, and acetaminophen are just as effective in relieving pain as the COX-2 inhibitors." So the question is, Why should Cox-2 drugs be on the market? Isn't it the right time to recall Celebrex? Or recall Bextra? Or even recall both?

Recommended article: Merck could have found out Vioxx risks earlier

Vioxx doubled heart attack risk, new study finds

As FDA discusses if Vioxx type drugs like Celebrex and Bextra should be on the market in the United States, another study has shown how dangerous Vioxx was to arthritis patients. The largest prospective trial ever examining the anti-inflammatory drug Vioxx, manufactured by Merck, as a chemoprevention agent found that the risk of developing a cardiovascular "event" - heart attacks and/or strokes - was almost double in patients who received the drug, compared to patients who took the placebo, according to a study published in The New England Journal of Medicine. (Related articles: Merck could have found out Vioxx risks earlier, Update on Celebrex, Bextra, Prexige, and Arcoxia, and Pfizer continues to affirm Celebrex safety)