First pre-trial Vioxx Hearing Begins

Judge Eldon E. Fallon of the U.S. District Court for the Eastern District of Louisiana has been assigned to coordinate all the pretrial motions and discovery in federal liability cases involving Vioxx and today's hearing is just the first in what is expected to be a lengthy and costly process.

Vioxx lawyers applying for a spot on the plaintiff steering committee know that only the highest profile attorneys will be selected and they know that selection to the committee may help them attract more cases.

Judges customarily select lawyers with extensive experience in product liability, who represent a number of plaintiffs in the case and whose firms have the money to fund their participation in a case likely to last years. Among those likely to be selected are attorneys Christopher Seeger of New York and Andy D. Birchfield Jr. of Montgomery, Ala.

According to papers the company filed with the court, there were 1,357 Vioxx liability lawsuits filed against Merck as of March 9, 2005. At this time, 127 have been moved to Judge Fallon's court and more than 400 others are expected to be moved.

For related stories: Vioxx Lawsuits

Vioxx Inquiry Panel Biased?

Conflicts of Interest Found on COX-2 Panel
Following the recent FDA inquiry into the COX-2 painkillers Vioxx, Celebrex and Bextra, the New York Times requested that the Center for Science in the Public Interest do some research into the 32 scientific experts chosen by the FDA to evaluate these drugs.

Despite clear guidlines in the Federal Advisory Committee Act, to prohibit scientists with direct conflicts of interest from serving on panels such as this. 10 of the 32 panel members were found to have links to Merck (Vioxx) and Pfizer Inc. (Celebrex, Bextra). "By failing to at least disclose those conflicts before the meeting, the (FDA) has undermined the credibility of the committee's advice," said Merrill Goozner, director of CSPI's integrity in science program

9 Out of 10 Voted for Vioxx Return
A further analysis of the voting done by the panel members shows that "the advisory committee would have voted against Bextra and Vioxx staying on the market had scientists with conflicts of interest been excluded from the vote." All of the 10 advisers with industry ties voted to keep Bextra on the market. Nine of them voted to let Vioxx be sold again.

To see the entire article: Vioxx Inquiry Panel Biased?

Making Sense of the Vioxx Problem

The past six months have been exciting, challenging, nerve wracking and even dangerous for those involved with the Vioxx problem. I call it the 'Vioxx problem", because it has been a problem for everyone including Merck and Co., the FDA, doctors, pharmacists, patients and their families.

Vioxx was recalled in September of last year. Patients have suffered heart attacks and strokes and lawyers have filed class action lawsuits. The FDA has held an inquiry. Merck share price has dropped and their have been class action lawsuits filed against them by their own shareholders.

This is a story that is a long way from being over and there are some valuable lessons to be learned. For more information on the legal aspects of the Vioxx problem see Vioxx Lawsuit News, but for ideas about health issues and the FDA read on:

This weeks issue of The Harvard Health Letter provides some interesting ideas regarding the saga of the COX-2 inhibitors, Vioxx, Celebrex and Bextra. They state:

-- There's no such thing as a medication free of side effects. Every drug carries some risks.

-- The balance of benefits and risks of any treatment differs from person to person. For instance, COX-2 inhibitors were showing promise in reducing the development of precancerous polyps and their growth into colon cancer. The Harvard Health Letter says that some people would certainly accept an increased risk of heart disease as the price for lowering colon cancer risk. -- Marketing changes the equation. When drugs are marketed heavily to patients and doctors, there's a powerful tendency to prescribe the newest options -— even though older and less expensive drugs often are just as effective.

-- Monitoring side effects post-approval is important. Studies often don't show rare or long-term effects that may become evident after a drug hits the market and many thousands of people are taking it. The FDA needs to do a better job of monitoring side effects at that point.

-- The FDA needs more options. Right now, the FDA has three basic choices when safety concerns surface: It can recall a drug, threaten to recall it, or order the manufacturer to change the drug's label. Some reformers would like to see the agency have further flexibility -— for instance, to temporarily suspend the sale of a drug while its safety record is examined.

The 'Vioxx problem' is not over. The lawsuits will continue and the people hurt by Vioxx, Celebrex and Bextra will continue to struggle. Hopefully the FDA will make changes and the end result of this mess will be something positive.

For the complete story see: The Harvard Health Letter or contact Christine Junge

Related stories: FDA Votes to Keep Vioxx, Celebrex and Bextra on Market and Safety Board Created

Doctors in Pain over Vioxx

At last weeks FDA inquiry into the COX-2 drugs Vioxx, Celebrex and Bextra, the meetings ended with the possibility that Vioxx could be re-introduced to the market. The news was met with horror from the heart attack victims, disgust and dismay from the lawyers that have or are planning to launch Vioxx lawsuits and elation from Merck and their lawyers.

The FDA panel of experts, even though they have some concerns, are recommending to the FDA that Vioxx be allowed back on the market. Lawyers for Merck, who will have to defend against hundreds of lawsuits, are elated. Anything short of an outright condemnation of Merck would have been seen as a victory. Now that there is a possiblity that Vioxx will return to the market, Merck attorneys will be able to point to the FDA inquiry and say 'The FDA didn't find a problem with Vioxx, they recommended that it be returned to the market!'

There is joy in the stock market too. Shares of Merck stock rose after the second day of the inquiry and again after the final day. The market feels that the panel's recommendation to allow Vioxx back on the market will lessen the chances that Merck will have to pay out billions of dollars in damages. The market also sees that a comeback by Vioxx, the huge profit generating drug, will positively affect Merck's bottom line. In short, the market sees less money spent on Vioxx litigation and more profits for Merck if Vioxx is re-introduced.

Will doctors prescribe Vioxx?
There are still many problems with a possible Vioxx return. All of the adverse publicity will make many patients and doctors wary.

"There are three similar drugs available in the market now, so it doesn't need to be brought back," said Dr Adal Al Eryani, interventional cardiologist at the Al Zahra Private Medical Centre.

"There have been some incidents of cardiovascular risks [due to Vioxx] which are not large-scale, but the side effects speak for themselves," he said.

Norman Wilkinson, head of training at the Department of Health ambulance service in the UAE, despite calling Vioxx a wonder drug, said: "I wouldn't feel comfortable prescribing it."

The FDA inquiry into Vioxx, Celebrex and Bextra is over and after three days of testimony it seems that we are left with more questions than answers. If you are a doctor, would you prescribe Vioxx? If you are in pain, would you take Vioxx?

Merck to Re-release Vioxx?

In an unusual turn of events. Merck, the makers of Vioxx have admitted that they may re-introduce Vioxx to the marketplace. During the three day FDA inquiry into Vioxx, Celebrex and Bextra, Peter S. Kim, president of Merck Research Laboratories said, "When we withdrew the drug it was based on the information available at the time."

"If the advisory committee and Food and Drug Administration conclude that the benefits of this class outweigh the risks in some patient populations, then we would have to consider the implications of these new data given the unique benefits Vioxx offers," said Kim.

"Given this new information, it is not clear that the cardiovascular risk observed ... makes Vioxx unique in the class of similar drugs marketed in the U.S.," Kim said. "We really await your decision."

Merck officials have claimed that all three COX-2 drugs carry the same increased risks for heart attack and stroke. Pfizer officials have taken the opposite position. They maintain that it's COX-2 drugs (Celebrex, Bextra) are different than Vioxx. They conclude that the cardiovascular risk of their drugs is less than that of Vioxx.

The advisory committee is set to vote on Friday on whether the risks and benefits of Vioxx, Celebrex and Bextra justify their marketing. The FDA usually, but not always, follows the advice of its advisory panels.

Related Vioxx News: Vioxx Bombshell to be Revealed to FDA

New Study Supports Previous Vioxx, Celebrex and Bextra Studies

A new study done by the nations largest provider of health benefits, WellPoint, supports previous studies that show the dangers of Vioxx, Celebrex and Bextra.

Results of the study, showed that using Vioxx and Celebrex increased patients' risk of heart attack and stroke by about 20 percent while Bextra increased the risk by 50 percent.

WellPoint studied the records of 7,232 patients over the age of 40 taking one of the three drugs and compared them with records of 629,245 people older than the age of 40 who were not taking any of the drugs. WellPoint examined patient records from January 2001 through June 30, 2004. All the patients were on the drugs for at least 18 months. Merck has insisted that patients must use Vioxx for at least 18 months before any damage is done. This assertion is now being challenged by many patients, doctors and lawyers.

Related story: Vioxx Upadate from Merck
WellPoint site: WellPoint COX-2 Study

Doctor Files Vioxx Law Suit

Florida Doctor Files Vioxx Litgation after Heart Attack
Palm Beach County doctor, Robert Plasko has filed a lawsuit against Merck, the makers of Vioxx and their sales representative, Angie Henderson. Dr. Plasko said he couldn't work anymore because of the effects he's suffered after taking the drug.

"I needed a cardiac catheterization and had a heart attack and had four stints placed into my heart," said Plasko.

The 50 year old Dr. Plasko had practiced endocrinology -- the study of glands, hormones and their related disorders, for 16 years and shut his practice down two months after suffering a heart attack. Plasko's suit contends Merck had unequivocal evidence as early as 2000 that Vioxx was unsafe and significantly increased the risk of heart attacks or strokes but hid the evidence.

"It's very tough because you get constant reminders every day when you swallow the morning's eight pills (to reverse Vioxx's effects)," said Plasko. He has to take the pills to counter the chest pains that started in August 2003, nine months after he started taking Vioxx.

Related story: 'Healthy Woman' files Vioxx Lawsuit

Heart Attack Survivor Joins Vioxx Class Action Suit

Vioxx Problem Grows for Merck
At 50 years of age, Marilyn Hainsworth's life was full of bike rides, swimming and hiking. Add to that some yoga and a 'near vegetarian' diet and you have a recipe for good health.

Then, 4 months after being prescribed Vioxx, Hainsworth found herself in the Kootenai Medical Center's new cardiac center being treated for a heart attack. A heart attack she believes was caused by the Vioxx medication she was taking for the pain caused by a repaired hernia.

Fortunately, due to her years as a trained wilderness responder and lifeguard she recognized the signs of a heart attack and survived. She had no history of heart problems.

These days Hainsworth is still working on restoring her health and has joined in the Vioxx class action suit filed by the lawfirm Owens, James, Vernon and Weeks from Coeur d'Alene, Idaho. The firm has filed suit on behalf of 42 plaintiffs including the family of a Sandpoint man that died after taking Vioxx.

Related Article: Vioxx Lawsuits to Begin this Spring and Selecting a Vioxx Attorney

Can Vioxx Litgation Bankrupt Merck

Vioxx Class Action Suits Increase Pressure on Merck
When Merck CEO, Raymond Gilmartin was asked if Vioxx litigation would bankrupt the huge drug maker, his answer was, "Absolutely not, anyone who looks at the strength of our balance sheet and our cash flow will see that."

However, some financial analysts feel differently, for these reasons:

*** Vioxx litigation costs will be high. An estimated 700 Vioxx lawsuits have been filed and more are expected. The number of actual Vioxx class action plaintiffs is now estimated in the tens of thousands.

*** Merck's Vioxx liabilities are potentially very high. Depending on the actual number of plaintiffs and the number of class action suits that are won by plaintiffs, estimates of Vioxx liabilities range from $18 billion to over $50 billion.

*** Merck has made no provisions whatsoever for its Vioxx liabilities. Management at Merck apparently believes that class action and individual settlements can be drawn out for an extended period of time. This may allow them to pay out damage awards from future cash flow.

Vioxx Litigation may Cost Billions

There is one thing that may save Merck and several other pharmaceutical giants including Pfizer Inc. (Celebrex, Bextra) and that is President Bush. Bush is promoting a piece of legislation, that if it becomes law, would restrict a citizens right to sue and would limit the amount off damages paid. The drug companies contributed huge sums of money to the Republican party in the last election. There are many that believe the president is running the best government that money can buy. Don't bet on Bush siding with the rights of the individual ahead of the needs of corporate America.

Related Articles: Vioxx, Celebrex Users Lose Rights and Bush Protects Makers of Vioxx, Celebrex

Vioxx Problem to be Formally Probed by SEC

In a press release issued today, Merck and Co. announced that notification has been recieved from the Securities and Exchange Commission that there would be a formal investigation into the Vioxx problem.

It is believed that the inquiry will center around whether Merck disclosed enough information about Vioxx. News of the SEC inquiry sent Merck shares falling again, this time by $2.53, or 8 percent, to $28.65 after falling as low as $28.32.

The Merck press release says that the SEC move 'wasn't unexpected', and notes that a formal probe gives the SEC staff the power to issue subpoenas for documents or testimony. Merck is also being probed at this time by the Department of Justice and certain Congressional committees.

Vioxx Problem Multiplies for Merck

Food and Drug Administration safety reviewer David Graham said in a study published this week by the U.K. medical journal Lancet that Vioxx may have caused as many as 140,000 heart attacks in the U.S. The Vioxx problem could become the single largest product safety lawsuit in history, with some estimates putting the number of plaintiffs in the tens of thousands.

Related story: European Agency to Probe Vioxx Problem

Federal Judges to Meet in Florida to Discuss Vioxx Lawsuits

A panel of seven federal judges will meet January 27th with attorneys at the federal courthouse in Fort Myers to hold multi-district litigation proceedings. The seven federal judges have a lot of decisions to make before the actual trial starts.

Vioxx class action lawyers from all over the U.S. will attend. They will be especially interested in three judicial decisions - where the trial will be held, who will be the lead attorneys, and if all the cases will be grouped together in one trial.

If you believe that you have been harmed by Vioxx you should consult with your doctor and discuss your case with a lawyer. Read Selecting a Vioxx Lawyer.

Vioxx Update from Merck

Today Merck and Co, Inc. released it's 2004 full year results. Most of the information provided was expected by analysts and obviously Merck has been seriously hurt by the Vioxx recall. However there were some interesting and unexpected revelations. Here are some highlights:

*** Merck is facing three different types of lawsuits. They are Vioxx Product Liability Lawsuits, Vioxx Securities Lawsuits and Employee Retirement Income Security Lawsuits.

*** Merck is being investigated by The Securities Exchange Commision, the U.S. Department of Justice and some Congressional Committees.

*** Merck has been named as a defendant in lawsuits in Europe, Canada, Brazil, Autralia and Israel.

*** Merck believes that it's insurance coverage may not be adequate to cover its defense costs and losses.

*** Merck has not established any reserves for any potential Vioxx liability.

What follows is Vioxx information taken directly from the Merck website:

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 Dec. 31, the company has been served or is aware that it has been named as a defendant in approximately 575 lawsuits, which include approximately 1,400 plaintiff groups alleging personal injuries resulting from the use of VIOXX. Certain of these lawsuits include allegations regarding gastrointestinal bleeding, cardiovascular events, thrombotic events or kidney damage. The company has also been named as a defendant in approximately 70 putative class actions alleging personal injuries or seeking (i) medical monitoring as a result of the putative class members' use of VIOXX, (ii) disgorgement of certain profits under common law unjust enrichment theories, and/or (iii) various remedies under state consumer fraud and fair business practice statutes, including recovering the cost of VIOXX purchased by individuals and third-party payors such as union health plans (all of the actions discussed in this paragraph are collectively referred to as the "VIOXX Product Liability Lawsuits"). The actions filed in the state courts of California and New Jersey, respectively, have been transferred to a single judge in each state for coordinated proceedings. In addition, the company has filed a motion with the Judicial Panel on Multidistrict Litigation seeking to transfer to a single federal judge and consolidate for pretrial purposes all federal cases alleging personal injury and/or economic loss relating to the purchase or use of VIOXX; several plaintiffs in certain VIOXX Product Liability Lawsuits pending in federal court have made similar requests. The hearing on these motions will be held on Jan. 27.

Also as previously disclosed, in addition to the VIOXX Product Liability Lawsuits, a number of purported class action lawsuits have been brought naming as defendants the company and several current or former officers of the company, and alleging that the defendants made false and misleading statements regarding VIOXX in violation of the federal securities laws (the "VIOXX Securities Lawsuits"). As of Dec. 31, 14 VIOXX Securities Lawsuits have been filed. In addition to the VIOXX Securities Lawsuits, as previously disclosed, shareholders have brought derivative lawsuits against the company. As of Dec. 31, six such lawsuits have been filed. In addition, the company has received a demand from two shareholders that the Board take legal action against Raymond V. Gilmartin, chairman, president and chief executive officer, and other unspecified individuals for allegedly causing damage to the company through the allegedly improper marketing of VIOXX. Also, as previously disclosed, lawsuits asserting claims under the Employee Retirement Income Security Act (ERISA) have been brought against the company. As of Dec. 31, 10 such lawsuits have been filed. The company has filed a motion with the Judicial Panel on Multidistrict Litigation to transfer to a single federal judge and consolidate for pretrial purposes all federal lawsuits discussed in this paragraph (collectively, the "VIOXX Shareholder Lawsuits" and together with the VIOXX Product Liability Lawsuits and the lawsuits discussed in the next paragraph, the "VIOXX Lawsuits"). The hearing on this motion will be held on Jan. 27.

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.

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

Also as previously disclosed, the company has product liability insurance for claims brought in the VIOXX Product Liability Lawsuits of up to approximately $630 million after deductibles and co-insurance. This insurance provides coverage for legal defense costs and potential damage amounts that have been or will be incurred in connection with the VIOXX Product Liability Lawsuits. The company believes that this insurance coverage extends to additional VIOXX Product Liability Lawsuits that may be filed in the future. Certain of the company's insurers have reserved their rights to take a contrary position with respect to certain coverage and there could be disputes with insurers about coverage matters. The company currently believes that it has at least approximately $190 million of Directors and Officers insurance coverage for the VIOXX Securities Lawsuits and VIOXX Derivative Lawsuits, and at least approximately $275 million of insurance coverage for the VIOXX ERISA Lawsuits. Additional insurance coverage for these claims may also be available under upper-level excess policies that provide coverage for a variety of risks. There may be disputes with insurers about the availability of some or all of this insurance coverage. At this time, the company believes it is reasonably possible that its insurance coverage with respect to the VIOXX Lawsuits will not be adequate to cover its defense costs and losses, if any.

The company currently anticipates that one or more of the VIOXX Product Liability Lawsuits may go to trial in the first half of 2005. The company cannot predict the timing of any trials with respect to the VIOXX Shareholder Lawsuits. The company believes that it has meritorious defenses to the VIOXX Lawsuits and will vigorously defend against them. In view of the inherent difficulty of predicting the outcome of litigation, particularly where there are many claimants and the claimants seek indeterminate damages, the company is unable to predict the outcome of these matters, and at this time cannot reasonably estimate the possible loss or range of loss with respect to the VIOXX Lawsuits. The company has established a reserve of $675 million solely for its future legal defense costs related to the VIOXX Lawsuits and the VIOXX Investigations. This reserve is based on certain assumptions and is the minimum amount that the company believes at this time it can reasonably estimate will be spent over a multi-year period. In accordance with GAAP and consistent with Merck's practice, the company significantly increased the reserve when it had the ability to reasonably estimate its future legal defense costs for the VIOXX litigation based on both actual costs incurred as well as the development of its legal defense strategy and structure in light of the expanded scope of the litigation. The company will continue to monitor its legal defense costs and review the adequacy of the associated reserves. The company has not established any reserves for any potential liability relating to the VIOXX litigation. Unfavorable outcomes in the VIOXX Lawsuits or resulting from the VIOXX Investigations could have a material adverse effect on the company's financial position, liquidity and results of operations.

Related Stories: Vioxx Lawsuits Begin this Spring and Selecting a Vioxx Attorney

Vioxx and Celebrex Overprescribed says Study

A study by doctors at Stanford University and the University of Chicago found that Vioxx and Celebrex were taken by millions of people who were not at risk of gastrointestinal bleeding. Aspirin and some other lower-cost painkillers can cause gastrointestinal bleeding and this was the main reason patients were told to switch to the more expensive COX-2 drugs.

The study results show that 73 percent of patients considered at low or very low risk of gastrointestinal problems should not have been considered for the newer drugs.

"We found a rapid, nationwide shift away from older, inexpensive drugs with better established safety and efficacy to newer, costly drugs with no real history," said study author G. Caleb Alexander, a medical ethicist at the University of Chicago.

Vioxx and Celebrex Overprescribed

The study also showed that by 2002, 17.6 million patients at low risk of gastrointestinal bleeding, or 66 percent of those patients, were taking one of the two COX-2 inhibitors.

Also included in the study is the alarming statistic that the drugs were taken by as many as 16 million people suffering from congestive heart failure, or liver or kidney dysfunction. Patients that clearly should not have taken Vioxx or Celebrex and might also have been hurt by these drugs.

The question being asked now is, "Who is a fault here?" The FDA, for not regulating and testing thoroughly enough? Merck and Pfizer, for advertising unsafe products directly to the public? Doctors, who felt that newer was better? Perhaps all of the above . . .

Related article: Vioxx and Celebrex Dangers

Vioxx Lawsuit Filed in Illinois

An article in the Madison-St.Clair Record by Steve Gonzalez says that the first Vioxx lawsuit in Madison County claiming damages, has been filed by David J McQuay.

McQuay claims that he was unaware of the dangers of Vioxx and that at the time Vioxx was sold to him it was "defective in design and unreasonably dangerous, subjecting him to risks of heart attack, strokes and other illnesses."

"Vioxx possessed serious life threatening side effects. . ."

Mr. McQuay is represented by attorneys Jeffrey Lowe, Joseph P. Dani and Evan Buxner and has also claimed that adequate testing was not done by Merck and that "Vioxx possessed serious life threatening side effects. . ."

The claim further states that, "Merck failed to warn users and doctors that numerous other methods of pain relievers, including Ibuprofen, Naproxen and Mobic were safer."

Mr. McQuay has developed heart disease and has undergone quadruple heart bypass surgery.

Related article: Can Vioxx Suits be Won?

Vioxx Lawsuits Begin this Spring

The first of over 700 lawsuits filed against Merck, the makers of painkiller Vioxx is scheduled to begin this spring.

A Houston judge has set May 2, 2005 as the date for the trial of a 37 year old man that died of a heart attack after taking Vioxx and a Los Angeles judge has set July 7 as the date for another Vioxx trial. This one will combine 5 plaintiff suits against Merck.

Other dates are expected to be set throughout the country and there is to be a hearing on January 21, 2005 to determine which judge will hear the Vioxx cases that have been filed in federal court.

Related articles: Selecting a Vioxx Attorney and Vioxx Attorneys Meet in Philadelphia

Vioxx Attorneys Meet in Philadelphia

It must have looked like a scene from a John Grisham novel, 250 lawyers crowded into Philadelphia's Wyndham Hotel ballroom. All of them 'Vioxx lawyers' trying to figure out the best way to attack the 'Bank of Merck'.

Since the FDA recalled Vioxx, product liability lawfirms have been building lists of clients that had allegedly been harmed by Merck's pain killer medication. Meetings like the one held this week in Philadelphia allow the lawyers to discuss strategies, case law, the role of the FDA and the preparation of witnesses. With billions of dollars at stake - these are inportant meetings.

Many of the 'Vioxx lawyers' at this meeting believe they have strong cases against Merck. They can cite numerous studies that link Vioxx to increases in heart attack and stroke. They can also refer to a series of internal company communications that suggests Merck executives knew about Vioxx's dangers before the recall.

On the other side of this issue stands Merck. They insist that they want to try each of the cases separately and not as a class action. They believe that it will be hard to prove a direct link between taking Vioxx and suffering a heart attack. They say many of the Vioxx patients were older and therefore already at risk. Also, Merck executives say the internal communications have been taken out of context and that they have nothing to hide.

Vioxx Lawyers vs Corporate Giants

It's going to be an interesting battle. The 'Vioxx lawyers' against the huge corporation. With billions of dollars on the line, you have to think that somewhere John Grisham is watching very closely.

Editors note: John Grisham is the author of 'The King of Torts', which gives some unique insites into the legal profession the the system of class action lawsuits.

Related article:Can Vioxx Lawsuits be Won

More Evidence of Vioxx and Celebrex Dangers

Two new articles published in this week's issue of the American Heart Association journal, 'Circulation', show more evidence that the COX-2 class of drugs, (Celebrex, Vioxx and Bextra) increase the risk of heart disease.

The first study shows that Pfizer Inc.'s Bextra can triple the risk of heart attack and stroke in certain patients.

Dr. Garret FitzGerald of the University of Pennsylvania School of Medicine and colleagues used a statistical approach called meta-analysis to combine the findings of two trials to estimate the risk of heart attack and stroke in people taking Bextra, another COX-2 inhibitor made by Pfizer.

Their analysis, first presented at a Heart Association meeting last November suggests Bextra tripled the combined incidence of heart attack and stroke in heart bypass surgery patients.

NSAIDS work by suppressing two enzymes called COX-1 and COX-2. But they can cause gastrointestinal bleeding, and research had suggested that suppressing COX-1 caused this damage.

So drug companies worked to make drugs that only affect COX-2, the enzyme associated with pain and inflammation.

But in the second study, the researchers studied mice genetically prone to hardening of the arteries or atherosclerosis and found that a compound called thromboxane or TxA2, produced by COX-1, accelerates atherosclerosis.

"This is of particular interest, as low-dose aspirin prevents heart attack and stroke by blocking COX-1 formation of TxA2 in blood cells called platelets," FitzGerald said in a statement.

When a COX-2 inhibitor was added, something happened that may help explain why the COX-2 inhibitors raise the risk of a heart attack, said FitzGerald's colleague, Karine Egan.

"Addition of the COX-2 inhibitor caused changes that, if they occurred in humans, would result in a loss of stability of the plaque, making it more likely to rupture and activate clotting, causing heart attack or stroke," she said.

"These results would have disturbing implications for patients at high cardiovascular risk treated with aspirin and a coxib (COX-2 inhibitor)," FitzGerald said.

If Pfizer needs any further reason to recall Celebrex and Bextra perhaps they should read Dr. FitzGerald's conclusions, "The clear emergence of a cardiovascular hazard from COX-2 inhibitors in patients, the weak rationale for a study of their protective properties in the first instance, and now this evidence from mice would indicate to me that a trial in high-risk patients, such as that proposed for Celebrex is, at best, ill advised."

Related story: Celebrex and Vioxx Drug Information

European Medicines Agency to Probe Vioxx and Celebrex

In a move that parallels that of the FDA, The European Medicines Agency will probe into the safety of the COX-2 drugs Vioxx, Celebrex and Bextra. Officials from Pfizer Inc, Merck & Co Inc and Novartis AG will appear before a panel of European drug experts next week, (Novartis has a new COX-2 drug called Prexige which they have not sought approval for due to the Vioxx controversy).

The European drug agency's Committee for Medicinal Products for Human Use has the power to recommend withdrawal, suspension or extra warnings. The committee is now considering whether to revise its advice to EU countries on use of all COX-2 drugs but will not necessarily make any immediate recommendations after its Jan 17-20 meeting.

"We are calling the companies in to present data and answer questions," Martin Harvey, a spokesman for the London-based agency, said.

Vioxx has been pulled from the market and its maker Merck faces billions of dollars in class action claims. Celebrex and Bextra are still available but their maker, Pfizer Inc. has pulled all advertising. The FDA has announced that they will further investigate the COX-2 drugs February 16, 17 and 18, 2005 in Gaithersburg, Md.

FDA to Probe NSAID's (Vioxx, Celebrex and Bextra)

The FDA announced Friday that it will hold three days of hearings in February on the benefits and risks of the COX-2 family of drugs. This includes Pfizer Inc.'s Celebrex and Bextra arthritis medications.

Kathleen Quinn, a spokeswoman for the FDA, said regulators would allow the public to comment, either orally, in writing or with data. Public comments would be allowed during the first day of the hearing between 1 and 3 p.m., but time would be limited.

Pfizer (Celebrex and Betra) officials have been asked to make presentations during the three-day hearing and will participate. They say they welcome the opportunity to be heard but haven't determined which officials will be making presentations.

What follows is the press release from the FDA web site:

FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs

The Food and Drug Administration (FDA) has announced a joint public meeting of the agency's Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee to be held February 16, 17 and 18, 2005.

The committees will discuss the overall benefit-to-risk considerations (including cardiovascular and gastrointestinal concerns) for COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) and related medicines.

Members of the public are encouraged to participate in this meeting. Interested persons may present data, information or views, orally or in writing, on issues pending before the committees. Oral presentations from the public will be scheduled between 1:00 p.m. and 3:00 p.m. on February 17. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should register to speak at the meeting before February 4, 2005. No registration is required for those only planning on attending the meeting.

The three-day meeting will be held at the Hilton Washington DC North, 620 Perry Parkway, Gaithersburg, Md. The proceedings will start at 8:00 a.m. each day. Agendas and other background materials will be posted online no later than one business day before the meeting.

For more information regarding this meeting, including contact information for members of the public interested in making presentations or submitting written comments please go to: http://www.fda.gov/oc/advisory/accalendar/2005/cder12532ddd0216171805.html.

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Vioxx and Celebrex Victims About to Lose Rights?

Over the years, two systems have emerged that act to protect the American consumer. The first is the various regulatory agencies that oversee the production and distribution of products. Among them are the Department of Labor, the Consumer Product Safety Commission and of course the Food and Drug Administration (FDA). Each of these organizations has various functions, but their principle job is to protect the American consumer from unsafe situations and products.

The second system that protects the consumer is the legal system and in particular, laws known as 'torts'. These laws allow the consumer to file suit against companies that have produced dangerous products or have acted fraudulently etc. If you have been harmed by a company or their products you have the right to sue that company.

When regulatory agencies fail to do a complete job and citizens are exposed to potentially dangerous products such as Celebrex, Vioxx and Bextra there has always been the option to use the tort laws and file suit. The tort laws provided a strong monetary incentive for companies to ensure that the products that they sold were safe for consumers to use.

Bush Wants to Change the Rules

It seems that this system is about to change. President Bush feels that agencies like the FDA are 'doing a spectacular job' and that the tort laws are too strong. He wants to change them to limit your ability to file suit and he wants to limit the amount of your settlement if you succeed in court. President Bush is seeking to limit the rights of people harmed by drugs like Vioxx.

Unforunately, as is so often the case with this president, he is out of step with reality. We are living in a world of instant gratification. Companies are pushing harder and harder to get products to market - often without ensuring that they are adequately tested. Competition is intense and the push to get new products to market is heightened by shareholders that want immediate results. So, does Bush do the logical thing and give agencies like the FDA more power and money to further protect American citizens? No. He seeks to limit their ability to file suit.

FDA Failed in Vioxx and Celebrex Cases

The simple truth here is that agencies like the FDA are no longer able to do their job properly. They are grossly underfunded and in many cases quite powerless. (The FDA can't even control pharmaceutical companies advertisiing direct to the public.) When regulatory agencies such as the FDA cannot do their job, the tort laws become the only defense against corporate negligence and greed.

With Bush in power and the Republicans having received millions from the pharmaceutical companies in re-election campaign funds, it's likely that things are about to change. Do you know someone that has been hurt by the use of Vioxx? Ask if they like the proposed changes.

For a related story: Bush Protects Makers of Vioxx and Celebrex