Vioxx-news

First pre-trial Vioxx Hearing Begins

2005-03-18T10:21:00.000-08:00

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?

2005-03-02T06:02:00.000-08:00

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

2005-02-25T05:43:00.000-08:00

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 -â 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 -â 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

2005-02-21T06:40:00.000-08:00

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?

2005-02-17T20:21:00.000-08:00

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

2005-02-15T15:28:00.000-08:00

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

2005-02-14T07:37:00.000-08:00

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

2005-02-08T14:55:00.000-08:00

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

2005-02-07T06:17:00.000-08:00

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

2005-01-28T11:07:00.000-08:00

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

2005-01-26T10:10:00.000-08:00

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

2005-01-25T11:28:00.000-08:00

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

2005-01-24T06:38:00.000-08:00

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

2005-01-24T06:31:00.000-08:00

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

2005-01-22T17:27:00.000-08:00

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

2005-01-21T11:51:00.000-08:00

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

2005-01-17T16:53:00.000-08:00

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

2005-01-16T10:40:00.000-08:00

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)

2005-01-15T10:09:00.000-08:00

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?

2005-01-13T07:11:00.000-08:00

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

Vioxx Lawyers in Advertising Boom!

2005-01-06T08:07:00.000-08:00

Trial lawyers throughout the U.S. have become increasingly aggressive in their attempts to attract Vioxx clients. With an estimated 20 million Vioxx users, the number of potential clients is far greater than any other class action lawsuit.

The number of potential clients combined with the huge possible financial windfall has caused lawyers everywhere to increase their advertising expenditures. This is most evident on the internet where law firms are building web sites and buying ads at a rapid pace. Lawyers are finding that the most cost effective way to reach potential clients is on the net. The cause of all this activity - Vioxx class action suits.

Can Vioxx Lawsuits be Won?

2005-01-06T07:26:00.000-08:00

Lawyers throughout the country have been collecting Vioxx clients at a rapid pace and have increased their advertising dramatically. Many Vioxx users have suffered serious heart problems and are looking for a legal remedy.

Vioxx Cases aren't 'Open and Shut'

Even though many feel that these are 'open and shut' type cases, it won't be that easy! Merck executives have already stated that they will defend every case and to be fair, Merck withdrew Vioxx as soon as it learned of the adverse side effects. The majority of those taking Vioxx suffered from arthritis or other joint related problems and tended to be older. This same group of people are statistically more susceptible to stroke and heart attack, so proving that a heart problem was solely caused by Vioxx could be difficult.

Further complicating the picture is the fact that Merck has just $630 Million in product liability for Vioxx claims. It is therefore a possibility that some claimants will find that the 'well has run dry'.

Also posing a potential problem is the proposed bill, supported by President Bush, that would severely limit the pharmaceutical companies' liability in class action suits if the drug in question had met all FDA requirements.

Bush to Protect Drug Firms?

2005-01-05T09:33:00.000-08:00

A medical malpractice bill that has passed the house but not the Senate has the support of President Bush. Bush has often praised the bill because it would stop the many frivolous lawsuits filed against doctors every year. What he doesn't often speak about are the provisions in the bill that would protect pharmaceutical companies.

Merck, the makers of Vioxx and Pfizer Inc. the maker of Celebrex would appear to be the two largest beneficiaries of this legislation. Vioxx was pulled from the market this past September and hundreds of Vioxx lawsuits have already been filed. Pfizer Inc. has not recalled Celebrex but has suspended all advertising. Several Celebrex lawsuits have been filed including one in Canada and one in Illinois.

Vioxx and Celebrex Lawsuits in Jeopardy

It is believed that both Merck and Pfizer would be shielded from punitive damages if this legislation becomes law. In fact, all pharmaceutical comapanies would be protected as long as they had met all FDA standards.

The exact extent of the protection allowed is not known however the position of the Association of Trial Lawyers of America is perfectly clear. Their president, Todd A. Smith said,

"President Bush unashamedly advocates legislation that would protect insurance industry profits and prohibit any punishment for the makers of dangerous drugs like Vioxx."

For more information see Vioxx Lawsuits

Vioxx Injuries and Deaths Estimated at 139,000

2005-01-02T22:15:00.000-08:00

The FDA scientist in the middle of the Vioxx controversy has stated in an interview with Andrew Jack of the Financial Times that he intends to publish research that idicates up to 139,000 people have been injured or killed by Vioxx.

Dr. David Graham had originally estimated that 28,000 people had been seriously affected by Vioxx and has since revised these estimates.

"In an interview with the FT, Dr Graham said he was determined to go ahead with publication of his updated analysis, even though he had been threatened with dismissal by the FDA if he wrote and published the paper."

"The FDA has suppressed the paper and maligned me in the media but never responded. The proper place for scientific information is in a peer-reviewed scientific journal," he said.

For the complete story: Vioxx Side Effects
Also see Doctors Need Drug Data

Celebrex and Vioxx Lawsuits Top Medical Stories for 2004

2005-01-02T10:54:00.000-08:00

COX-2 inhibitors, painkillers Vioxx and Celebrex came under fire in 2004. Vioxx was recalled from the market amid claims that its continued use would result in heart complications. Hundreds of Vioxx lawsuits have been filed as a result. Merck, the makers of Vioxx have stated that they will defend against all Vioxx class action lawsuits.

Celebrex, another of the COX-2 type drugs has also (along with Bextra) been identified as causing the same type of heart problems as Vioxx. The makers of Celebrex, Pfizer Inc. has suspended all Celebrex advertising, but has not recalled the product. Pfizer executives site the many years of safe use of Celebrex and insist that using Celebrex is not unsafe. Like Merck (makers of Vioxx) Pfizer executives have stated that they will fight any Celebrex related lawsuits.

2004 has ended with many pain sufferers looking for alternatives to Vioxx and Celebrex. Questions are being asked about the effectiveness of the FDA and it's handling of the Vioxx, Celebrex and Bextra situations. Hundreds of Vioxx lawsuits and at this writing, at least two Celebrex class action lawsuits have been filed - but above all else, people want answers.

What will 2005 bring? It's anyones guess, but the Vioxx and Celebrex stories aren't over yet.

For more information: FDA Advisory: Vioxx, Celebrex & Bextra

Doctors Need Drug Data

2004-12-30T08:29:00.000-08:00

In an article for the New York Times News Service, writer Barry Meier reports that doctors are having a difficult time assessing pain relievers with the recent Vioxx recall and the problems now associated with Celebrex, Bextra and Aleve.

"We are desperately in need of information," said Dr. Stephen Brenner, an internist in New Haven, Conn.

However, it seeems that for some, the information has been available. The Mayo Clinic, the federal Veterans Affairs Department and the Kaiser Permanente Health Plan all did reviews of available test data and as a result limited the use of Vioxx, Celebrex and Bextra. Reviews like this are called evidence-based reviews and are used to determine the real benefits and drawbacks of various drugs.

So, why aren't these reviews made available to all doctors . . .?

For the entire story: Celebrex, Bextra, Vioxx Information

Cardiologists Call for More COX-2 Testing

2004-12-30T07:13:00.000-08:00

In an article posted Tuesday on the Journal of the American Medical Association's website, Eric Topol, chief cardiologist at the Cleveland Clinic Foundation, states that health risks found in drugs such as Celebrex, Vioxx and Bextra underscore the need for health authorities to test drugs already on the market.

Vioxx, Bextra and Celebrex are the only Cox-2 inhibitors authorized by the FDA since the 1990s and "Had coxib trials been conducted five years ago in patients with established cardiovascular disease, when the benefit and risks were indeterminate, clinicians would have quickly learned the risk and potentially avoided a major cardiovascular calamity," wrote Topol.

For the rest of the story: Celebrex Side Effects

FDA Advisory - Vioxx, Celebrex and Bextra

2004-12-27T18:09:00.000-08:00

On December 23rd the FDA issued the following Public Health Advisory with regard to the COX-2 group of drugs that include Vioxx, Celebrex and Bextra

FDA Issues Public Health Advisory Recommending Limited Use of Cox-2 Inhibitors
Agency Requires Evaluation of Prevention Studies Involving Cox-2 Selective Agents

The Food and Drug Administration (FDA) today issued a Public Health Advisory summarizing the agency's recent recommendations concerning the use of non-steroidal anti-inflammatory drug products (NSAIDs), including those known as COX-2 selective agents. The public health advisory is an interim measure, pending further review of data that continue to be collected.

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

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

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

Although the results of these studies are preliminary and conflict with other data from studies of the same drugs, FDA is making the following interim recommendations:

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

Non-selective NSAIDs are widely used in both over-the-counter (OTC) and prescription settings. As prescription drugs, many are approved for short-term use in the treatment of pain and primary dysmenorrhea (menstrual discomfort), and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis. FDA has previously posted extensive NSAID medication information at http://www.fda.gov/cder/drug/analgesics/default.htm.

FDA is collecting and will be analyzing all available information from the most recent studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for COX-2 selective and nonselective NSAID products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005, which will provide for a full public discussion of these issues.

FDA Issues Public Health Advisory

2004-12-24T08:05:00.000-08:00

Public Health Advisory
Vioxx and other Non-Steroidal Anti-Inflammatory Drug Products (NSAIDS)

The FDA is issuing a public health advisory concerning use of non-steroidal anti-inflammatory drug products (NSAIDS) including those known as COX-2 selective agents.

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

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

While the results of these studies are preliminary and conflict with other study data on the same drugs, FDA is providing this advisory as an interim measure, pending further review of data that continue to be collected. Specifically:

* Physicians prescribing Celebrex (celecoxib) or Bextra (valdecoxib), should consider this emerging information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal (GI) bleeding, have a history of intolerance to non-selective NSAIDs, or are not doing well on non-selective NSAIDs may be appropriate candidates for COX-2 selective agents.
* Individual patient risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account for each prescribing situation.
* Consumers are advised that all over-the-counter (OTC) pain medications, including NSAIDs, should be used in strict accordance with the label directions. If use of an OTC NSAID is needed for longer than ten days, a physician should be consulted.

Non-selective NSAIDs are widely used in both over-the-counter (OTC) and prescription settings. As prescription drugs, many are approved for short-term use in the treatment of pain and primary dysmenorrhea (menstrual discomfort), and for longer-term use to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis. FDA has previously posted extensive NSAID medication information at http://www.fda.gov/cder/drug/analgesics/default.htm.

FDA will be analyzing all available information from the new studies of Vioxx, Celebrex, Bextra, and naproxen, and other data for non-selective NSAIDs and COX-2 selective products to determine whether additional regulatory action is needed. An advisory committee meeting is planned for February 2005 which will provide for a full discussion of these issues.

For more Information: Vioxx, Bextra, Celebrex Information

Celebrex, Bextra and Vioxx Side Effects on Health Canada

2004-12-22T21:23:00.000-08:00

The following press release has been posted on the Health Canada website regarding safety considerations and side effects of Vioxx, Celebrex, Bextra and Mobicox.

OTTAWA -Health Canada wishes to inform Canadians of safety concerns regarding the group of drugs known as selective COX-2 inhibitor NSAIDs (non-steroidal anti-inflammatories). These include Vioxx (rofecoxib), which has been withdrawn from the market, Celebrex (celecoxib), Bextra (valdecoxib), and Mobicox (meloxicam), which are used in the treatment of symptoms of rheumatoid arthritis, osteoarthritis and primary dysmenorrhea (menstrual pain).

Accumulating evidence indicates that the use of selective COX-2 inhibitor NSAIDs, in certain individuals, is associated with an increased risk of heart attack or stroke when compared to placebo. The risk appears to increase with the total daily dose and the length of the treatment. However, given the available data, it is not possible to identify which patients would present a higher risk of heart attack and stroke.

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

Until further information from long-term clinical trials becomes available, one should consider that there is a strong possibility of an increased risk of cardiovascular events, including heart attack and stroke, when using selective COX-2 inhibitor NSAIDs (Celebrex®, BextraTM, Mobicox®, and all generic forms of meloxicam).

Patients should discuss the benefits and risks of treatment options with their physician, in light of the following information.

Vioxx® (rofecoxib)
Vioxx® was withdrawn on September 30, 2004, based on new safety information from a three-year, randomized double-blind clinical trial, called APPROVe, showing a possible increased risk of cardiovascular events. The APPROVe (Adenomatous Polyp Prevention on VIOXX) clinical trial was designed to assess the effectiveness of 25 mg Vioxx® in preventing the recurrence of colon polyps (abnormal tissue growth, which may or may not be cancerous). In the APPROVe trial, Vioxx® was compared to a placebo (sugar pill). Merck & Co withdrew Vioxx from the worldwide market after the study indicated an increased risk of serious cardiovascular events, such as heart attacks and strokes, after 18 months of continuous treatment.

BextraTM (valdecoxib)
On December 10, 2004, Pfizer Inc. released new information about cardiovascular risks associated with BextraTM. In a study conducted by Pfizer, which included over 1,500 patients treated for acute pain after coronary artery bypass grafting (CABG), an increased risk of cardiovascular events was observed in patients treated with BextraTM compared to placebo. These cardiovascular events included myocardial infarction (heart attack), cerebrovascular accident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung). The risk of these effects was observed to be greater with the intravenous form of the drug (approximately two percent of patients had such an adverse event), in comparison with the oral form of the drug (approximately 1 percent of patients), immediately following CABG surgery. About 0.5 percent of patients taking the placebo had an adverse cardiovascular event.

Celebrex® (celecoxib)
On December 17, 2004, the National Cancer Institute (NCI) in the United States announced that it had stopped a three-year Celebrex® study called Adenoma Prevention with Celecoxib (APC) due to an interim analysis showing a statistically significant increase in the risk of heart attack, stroke and cardiovascular death. Health Canada has withdrawn market authorization for the use of Celebrex® for the prevention of recurrence of Familial Adenomatous Polyposis, which is predictive of colorectal cancer. Celebrex® should not be taken for the prevention of recurrence of Familial Adenomatous Polyposis and patients should discuss alternative therapeutic options with their doctors.

Facts About Vioxx Lawsuits

2004-12-17T08:54:00.000-08:00

What follows is a Press Release from PRweb.com on behalf of LegalServicesInfo.com. For more information contact LegalServicesInfo.com

PRWebhttp://www.prweb.com/releases/2004/12/prweb186255.htmHundreds of affected consumers are now bringing cases against Merck, the maker of Vioxx. (PRWEB) December 10, 2004 -- Over the past two months, there has been a large public outcry due to the prescription drug Vioxx. Many people who have taken the drug are having heart attacks, strokes and other serious medical problems. The drug was recalled after four years on the market, with billions of dollars in revenues for its manufacturer, Merck. Now the manufacturer faces a series of lawsuits and billions of dollars in claims. Not surprisingly, people who have taken Vioxx are seeking legal representation for their Vioxx Claims. Vioxx recall lawyers, who's main practice falls under product liability law, are providing those who have been affected by Vioxx with answers to their legal questions. Did you know that analysts estimate that Merck's legal costs could reach $12 billion, and that their liability could be well over $17.6 billion over the next decade? Vioxx class action lawsuits have already been filed and Vioxx claim cases are being submitted by the thousands. If you have taken the drug and suffered a Vioxx heart attack or Vioxx stroke, then you cou ld be a part of that compensation. There are many Vioxx side effects, so be sure and contact your doctor to be sure about your health.Lawsuits have already been brought against Merck over their Vioxx drug. Some of these case are:-Elizabeth Aiken v. Merck & Co. Inc., No. 04-CV08085, S.D. N.Y. -Sidney Schneider v. Merck & Co. Inc., et al., No. 04-22632, S.D. Fla. -Sharon Scott Jones v. Merck & Co. Inc., No. 04-3079, N.D. Ala. -Robert V. Purcell v. Merck & Co. Inc., et al., No. 04-CV-2089, C.D. Calif.In all, more than 375 Vioxx lawsuits are now awaiting trial against Merck. The story is the same in Europe, Canada, Brazil and Israel. For Merck, the legal stakes are high. The nightmare has just begun. It comes as no surprise then, that the company's stock lost 40% of its value overnight. Figures of 27,785 heart attacks and deaths from 1999 to 2003 were levelled at them. Merrill Lynch in Nov 2002, estimated that the company could be held responsible for as high an amount as $18 billion which could include $15.3 billion compensation for serious cardiovascular damages, $1 billion to $2 billion for "nuisance" case events and $1 billion incurred in litigation-related expenses. More than a 1,000 Victims" groups hold Merck morally and legally responsible for personal injuries due to the use of Vioxx. Certain Vioxx lawyers, in their lawsuits, even allege gastrointestinal bleeding, cardiovascular events and kidney damage. Many of those people who have been affected by Vioxx are turning to the internet to connect with legal counsel. LegalServicesInfo.com connnects people who have taken Vioxx and had a serious side effect with a Vioxx lawyer. Those who would like to join a Vioxx lawsuit or Vioxx class action can easily be matched up with a Vioxx attorney and be represented. About LegalServicesInfo.com LegalServicesInfo matches up people who have been affected by Vioxx with Vioxx lawyers, Vioxx attorneys and Vioxx law firms. If you are one of the millions of people who have taken Vioxx and are concerned with Vioxx side effects, contact Vioxx law firm today.
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REGENCY MARKETING

Vioxx Refunds Made Easier

2004-12-14T17:58:00.000-08:00

Merck & Co. agreed Monday to simplify the Vioxx refund process, according to Attorney General Jim Petro. Merck made this decision following negotiations with Petro and the attorneys general of seven other states.

Merck will no longer require that Vioxx users send in their unused drugs before receiving a refund and will also pay shipping costs for customers sending in their unused Vioxx. The deadline to apply for a refund has been extended through March.

Consumers needing information about the Vioxx recall should contact the Merck Refund Center at 800-805-9542.

Click here for more Vioxx Recall Information

British Group Prepares for Vioxx Lawsuit

2004-12-14T05:50:00.000-08:00

In a report for the Liverpool Daily Post, reporter Deborah James states that a British law firm is preparing to file suit against Merck & Co., the makers of Vioxx.

Each of the six clients, suffered a stroke, suspected stroke, increased blood pressure or a heart attack while taking the drug.

A company spokesperson told the Post "Merck's position has always been that it will defend against any legal action brought against it.

"The company has acted responsibly and withdrew the drug as soon it became aware of the risk. No previous trials conducted by Merck had shown any cardiovascular risk compared to the placebo."

For more on this story: Vioxx Lawsuit

For more Vioxx Lawsuit information

Vioxx Lawyers, Vioxx Recall and Vioxx Lawsuits

2004-12-13T20:18:00.000-08:00

Many people who have taken the drug Vioxx have experienced heart attacks, strokes and other serious medical problems. Vioxx was recalled after four years on the market, after earning billions of dollars in revenues for its manufacturer, Merck.

Now Merck is facing a series of lawsuits and billions of dollars in claims with more than 375 Vioxx lawsuits already awaiting trial. This nightmare has spread to Europe, Canada, Brazil and Israel.

With thousands of heart attacks and deaths being attributed to Vioxx, many of the victims hold Merck morally and legally responsible.

For more: Vioxx Lawsuit Information

German Doctors Warned about Vioxx Type Drugs

2004-12-13T06:16:00.000-08:00

In an article published December 13 2004, David Firn writing for the Financial Times in London reports that

"German doctors have been told to restrict the use of all anti-inflammatory drugs belonging to the same group of popular painkillers as Vioxx, the Merck product that was withdrawn because of safety fears."

The German doctors' drug commission said the entire class of painkillers, known as cox-2 inhibitors, should be restricted. This information comes at a time when US regulators are issuing warnings regarding the risks of Pfizer's Bextra.

For the complete story: Vioxx Recall

Suit Seeks Money Spent on Vioxx

2004-12-11T18:03:00.000-08:00

While most of the Vioxx lawsuits filed following the Vioxx recall will allege bodily injury due to taking the product, one recent suit is focused on recovering money spent on the product. Michael Kiefer writing for the Arizona Republic reports that a suit filed by attorney Robert Carey in the name of Edward W. Wright says maker of arthritis pain reliever misrepresented risks and benefits.

The class-action suit against pharmaceutical giant Merck & Co. Inc was filed yesterday to recover consumer money spent on the arthritis pain reliever Vioxx, which was taken off the market in September.

A spokesman for Merck said they has a "strong and meritorious" defense and will vigorously defend itself against the Vioxx lawsuit.

For the whole story, see Vioxx Lawsuit

FDA Can't Protect the Public from Another Vioxx

2004-12-10T17:42:00.000-08:00

"I would argue that the FDA, as currently configured, is incapable of protecting Americans against another Vioxx," scientist David Graham said. Graham named five other drugs - Accutane, Bextra, Crestor, Meridia and Serevent - that might have similar problems with side effects. The manufacturers of all of these drugs said they are safe.

Unfortunately all drug manufacturers say their drugs are safe and the FDA seems unable or unwilling to force drug companies to do sufficient testing. Money is the most obvious problem here. Proper testing can take years and millions of dollars. The payoff however can be enormous.

So, how many people have to die and how many more 'Vioxx' type drugs are out there?

Vioxx Recall Robs Woman of the Drug She Loved

2004-12-07T15:40:00.000-08:00

In a story by Virginia Anderson (for The Atlanta Journal-Constitution), 60 year old Brenda Slater says that Vioxx "saved her life". Vioxx was recalled Sept. 30th and when her prescription ran out, "All the old aches and pains came back," she said.

Vioxx has been like a 'wonder drug' for the millions of athritis sufferers and, as the nation's 77 million baby boomers age, the market for arthritic pain relief will surely grow.

With Vioxx off the market, arthritis patients and their doctors are looking to Celebrex and Bextra to replace Vioxx and are also considering some of the old style treatments.

For more Information see: The Atlanta Journal-Constitution

viox recall, viox, viox lawsuit

Celebrex Safer than Vioxx

2004-12-07T14:01:00.001-08:00

In an Associated Press article by Patrick Walters, new research results suggest that celebrex is safer than Vioxx. A study by University of Pennsylvania researchers claims that Celebrex does not carry the same heart attack risk as Vioxx.

The study, funded by the makers of both drugs and the federal government, was published in today's Annals of Internal Medicine. Result of the study showed the chances of having a heart attack were 2.72 times greater in Vioxx users than in Celebrex users.

However, in an accompanying editorial, two Boston doctors warned that the connection between heart disease and cox-2 inhibitors remains unclear.

For more Vioxx information see: The Kansas City Star

Tennesee Woman's Vioxx Lawsuit is Different

2004-12-07T14:01:00.000-08:00

A Tennesee woman, Barbara Cathey has filed a class action lawsuit against Merck, the makers of Vioxx. Cathey's suit differs from other Vioxx litigation filed in state courts across the country because the suit is not a personal injury claim.
According to attorney Lewis Garrison Jr. the claim seeks medical monitoring for Cathey and other yet-to-be-named plaintiffs. The key difference is that these Vioxx users have not yet suffered a stroke or heart attack caused by the use of Vioxx.
For more information see: The Tennessean

Merck Sued by New York Fund over Vioxx Issue

2004-12-07T13:27:00.000-08:00

(New York - Dow Jones/AP) — State comptroller Alan Hevesi has sued Merck & Company, claiming the drug maker hid certain risks associated with the painkiller Vioxx.

Merck pulled its Vioxx pain medication from shelves September 30th after a clinical trial showed patients taking the drug showed an increased risk for heart attacks and strokes after 18 months.

The company has been the subject of several investor lawsuits since it pulled Vioxx off the market. Its stock has lost more than a third of its value since the recall.

One of the losers has been New York state's pension fund.

Hevesi says the fund has recorded 171 million dollars in paper losses related to New Jersey-based Merck. As of September 30th, the state held nine-point-four million shares of Merck.

viox, viox news, viox recall, viox lawsuit

Vioxx News Update - FDA Statement

2004-12-07T07:13:00.000-08:00

FDA Statement On Vioxx

The Food and Drug Administration (FDA) acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) manufactured by Merck & Co. FDA also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.

Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.

“Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market,” said Acting FDA Commissioner Dr. Lester M. Crawford. “Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo.”

Dr. Crawford added that FDA will closely monitor other drugs in this class for similar side effects. “All of the NSAID drugs have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician.”

FDA approved Vioxx in 1999 for the reduction of pain and inflammation caused by osteoarthritis, as well as for acute pain in adults and for the treatment of menstrual pain. It was the second of a new kind of NSAID (Cox-2 selective) approved by FDA. Subsequently, FDA approved Vioxx to treat the signs and symptoms of rheumatoid arthritis in adults and children.

At the time that Vioxx and other Cox-2 selective NSAIDs were approved, it was hoped that they would have a lower risk of gastrointestinal ulcers and bleeding than other NSAIDs (such as ibuprofen and naproxen). Vioxx is the only NSAID demonstrated to have a lower rate of these side effects.

Merck contacted FDA on September 27, 2004, to request a meeting and to advise the agency that the long-term study of Vioxx in patients at increased risk of colon polyps had been halted. Merck and FDA officials met the next day, September 28, and during that meeting the company informed FDA of its decision to remove Vioxx from the market voluntarily.

In June 2000, Merck submitted to FDA a safety study called VIGOR (Vioxx Gastrointestinal Outcomes Research) that found an increased risk of serious cardiovascular events, including heart attacks and strokes, in patients taking Vioxx compared to patients taking naproxen. After reviewing the results of the VIGOR study and other available data from controlled clinical trials, FDA consulted with its Arthritis Advisory Committee in February 2001 regarding the clinical interpretation of this new safety information. In April 2002, FDA implemented labeling changes to reflect the findings from the VIGOR study. The labeling changes included information about the increase in risk of cardiovascular events, including heart attack and stroke.

Recently other studies in patients taking Vioxx have also suggested an increased risk of cardiovascular events. FDA was in the process of carefully reviewing these results, to determine whether further labeling changes were warranted, when Merck informed the agency of the results of the new trial and its decision to withdraw Vioxx from the market.

What Next? Former Vioxx Users Have Several Options

2004-11-30T19:31:00.000-08:00

A Washington Post article by January W. Payne has some of the most valuable information available for previous Vioxx users. If you are interested in Vioxx alternatives, Vioxx side effects, or the Vioxx recall this is a must read.

If you or someone you know used Vioxx and has any questions about any lingering effects of Vioxx or almost anything else about the drug then click the link below to read this entire article. You'll even learn where to send your unused Vioxx for a refund.

Read the entire Vioxx article here: Winston -Salem Journal

Merck Demands Specific Proof in Vioxx Suits

2004-11-30T19:16:00.000-08:00

from Bloomberg.com
Nov. 30 (Bloomberg) -- Keith Stubblefield took Merck & Co.'s Vioxx painkiller for six weeks before he had a fatal heart attack while washing his car. His widow sued Merck, saying that Vioxx killed him and that the company hid the drug's risks.

Merck, which recalled Vioxx on Sept. 30 after a company study found it doubled heart attack and stroke risk after 18 months of daily use, denied the drug caused Stubblefield's death in March 2001. The No. 2 U.S. drugmaker argued in court papers that Stubblefield, 37, was an overweight smoker with high blood pressure and heart disease.

``It is not possible because of the absence of medical records and the lack of an autopsy to say with scientific certainty precisely why Mr. Stubblefield died,'' J. Michael Gaziano, a Harvard Medical School cardiologist, said in a statement Merck filed in federal court in Houston on July 9 in an attempt to dismiss the suit.

The tactics Merck is using in the Stubblefield suit, including a refusal to settle, are typical of those it is using in hundreds of Vioxx cases to limit its liability, court papers show. Merrill Lynch & Co. estimates the Whitehouse Station, New Jersey, company's liability could reach $18 billion.

Merck refused to allow interviews for this story with its staff lawyers or attorneys at Hughes Hubbard & Reed in New York, who are leading the defense.

Merck, which sold $2.5 billion in Vioxx last year, has lost $38 billion in market value since the drug's recall. The company's shares fell 3 cents to $27.67 in New York Stock Exchange composite trading yesterday.

The Stubblefield suit, filed in 2002, is set for trial in May and may be the first to be put before a jury. Jurors will weigh whether Stubblefield's death was due to his lifestyle or his use of Vioxx. Stubblefield, a father of four, managed a Captain D's restaurant.

`Very Confident'

``I'm very confident,'' said Carlene Rhodes Lewis, a Houston lawyer who represents Stubblefield's estate and his family in the product-defect suit. ``His death was caused by Vioxx, regardless of pre-existing conditions and what Merck says about his medical problems. Those sorts of things always depend on the jury. I suppose the jury could see Merck making those sorts of excuses as something that helps our case.''

In court papers in hundred of suits filed by Vioxx users or their survivors, Merck argued that every plaintiff must prove that the drug, not something else, caused the alleged injury or death. The litigation includes 182 suits before Superior Court Judge Carol Higbee in Atlantic City, New Jersey. Those suing ``have to present expert testimony of causation of injury to prove their allegations in each case,'' she said in a Nov. 12 opinion.

`Scientific Evidence'

``This testimony must be based on scientific evidence,'' she wrote. ``The core battle in cases such as this is in the battle of the opinions of highly qualified scientific experts.''

Such battles probably will intensify because lawyers are expected to file additional suits after advertising for Vioxx clients on television, radio and the Internet.

Vioxx had 20 million users, the company said. U.S. Food and Drug Administration scientist David Graham estimated during U.S. Senate hearings on Nov. 18 that the drug hurt or killed between 88,000 and 139,000 people. Graham had previously linked the drug to 27,785 heart attacks and deaths.

Merck said in court papers filed in defense of the suits that no drug is completely safe, that the FDA got all of the company's safety data on Vioxx and that clinical trials failed to prove it harmed patients.

``Merck's attitude before the withdrawal was they knew it was a well-loved drug and they are a well-respected company,'' said attorney Leila Watson of Birmingham, Alabama. ``These doctors were so convinced that there was nothing wrong with it because it did such a great job of relieving pain.''

`Dangerously Defective'

Watson sued on behalf of the estate of Rebeka Fulton, who died of a pulmonary embolism on Sept. 14, 2000, in Hot Springs, Arkansas, after taking Vioxx for a month.

``I've got to prove that the drug is dangerously defective, what the defect is and that it can cause heart attacks, strokes and clotting problems, and that Merck knew or should have known,'' she said in an interview.

In an Oct. 13 news conference, Merck General Counsel Kenneth Frazier said there was no ``reliable way'' to estimate actual Vioxx use in the population and the actual number of cardiovascular problems caused by Vioxx.

``Because heart attacks and strokes occur in the general population, in any particular case, one cannot say that if one had a cardiovascular event while taking Vioxx that Vioxx caused it,'' Frazier said.

Blockbuster Drug

Vioxx users or their survivors suing Merck have claimed the company knew the risks of Vioxx before its May 1999 launch and hid them because it needed a blockbuster drug to maintain revenue. Stubblefield's wife and other who sued argue that Merck spent hundreds of millions of dollars to persuade doctors and consumers to use Vioxx for pain instead of the cheaper naproxen, which can cause stomach bleeding.

Merck ran an 8,000-patient study, known as Vigor, comparing gastrointestinal benefits of patients on high doses of Vioxx to those on naproxen, the company said in press releases and court papers. Vigor excluded patients with heart risks.

In March 2000, Merck reported results from Vigor, which found that patients taking Vioxx had less stomach bleeding than those taking naproxen and had up to four times as many heart attacks and strokes, the company said in statements. Merck said that the cardiovascular results contradicted other studies and suggested naproxen may protect the heart, an interpretation disputed by many scientists.

Raymond Gilmartin

Merck spent 22 months working with the FDA to develop warning information for prescribing physicians, company statement said. The company also began a trial in February 2000, known as Approve, comparing cardiovascular events of Vioxx users with those taking placebos, the company said in statements.

Chief Executive Raymond Gilmartin said in an interview that Merck learned on Sept. 23 that the Approve study showed Vioxx increased cardiovascular risks after 18 months of daily use, prompting the largest drug recall ever a week later.

The Stubblefield case is Kimberly D. Stubblefield v. Merck, No. 02-3139, U.S. District Court, Southern District of Texas (Houston).

To contact the reporters on this story:
David Voreacos in Newark, New Jersey dvoreacos@bloomberg.net.

To contact the editor responsible for this story:
Patrick Oster at poster@bloomberg.net

viox, viox recall, viox lawsuit

Unsafe Prescription Drugs Tough to Get

2004-11-30T19:10:00.000-08:00

Wyoming's participation in a drug review project has made unsafe drugs, such as Vioxx, difficult to get - even before the FDA pulled it from the market.

The Drug Effectiveness Review Project has enabled the Wyoming Health Department to create a preferred drug list from regularly compiled research reviews. The reviews compare all published research on drug safety and effectiveness, and qualify the studies. Each of the 12 participating states then use the data to choose the drugs to make available in their perspective markets, according to Aimee Lewis, pharmacist consultant with the Wyoming Department of Health.

Participation cost Wyoming about $96,000 in its first year.

Wyoming originally joined the program because preferred drug lists are one way to help control Medicaid costs, Lewis said, though drugs on the list are based on safety, effectiveness and cost.

Wyoming joined the project in October 2003 and excluded Vioxx from the preferred list "for the most part" because of cost, she said, though the project raised safety questions about it as early as 2002.

The review project has been under way for about three years, and Congress is now working to establish a national independent review board like it.

For the complete story see today's News-Record.

Questions Derailed Publication of Vioxx Safety Study

2004-11-30T19:04:00.000-08:00

WASHINGTON (AP) - Government questions about its accuracy derailed publication of a report raising safety concerns about arthritis drug Vioxx on the eve of a contentious congressional hearing, according to an e-mail exchange.

Without a clear agency go-ahead, Food and Drug Administration safety reviewer David Graham withdrew the paper from consideration for publication in The Lancet medical journal.

The paper said high doses of Vioxx tripled the risk of heart problems compared with a rival painkiller.

The whistleblower told Congress on Nov. 18 that drug regulators fumbled on safety with Vioxx.

Graham said the dysfunctional agency left America virtually defenseless against the next Vioxx debacle and he named five other problematic drugs on the market.

The Lancet's editor, Richard Horton, had already pointed to "lethal weaknesses'' in FDA's regulatory oversight regarding Vioxx in a scathing editorial published in early November.

Graham's paper was a peer-reviewed version of research he presented this summer in France.

It would have noted that heart attacks and sudden cardiac deaths were higher among Kaiser Permanente patients taking high or low-dose Vioxx, compared with Celebrex.

The FDA said Monday it didn't try to thwart publication of the article, but at the same time noted that Vioxx already had been withdrawn from the market.

Merck & Co. cited an increased risk of heart attack and stroke when it pulled the drug Sept. 30.

According to the e-mails, FDA superiors peppered Horton with last-minute concerns about the article's scientific accuracy.

USA Today published a story on the exchange Monday.

"You will not be surprised if I say that I was a little taken aback to get your call,'' Horton replied by e-mail from England.

"It is very unusual, indeed, for a member of the employing institution of an author to contact us in the middle of the review and publication process of a manuscript.

Such an intervention could easily be perceived as an improper injunction in our peer review process.''

FDA reviewers "identified scientific issues with the paper,'' Dr. Steven Galson, acting director of the agency's Center for Drug Evaluation and Research, wrote Horton on Nov. 12.

"Some of the questions involve basic data integrity. (Graham) has declined to address these issues, and we think it's important that your readers know this.''

Graham's study examined the records of 1.4 million Kaiser Permanente patients taking typical doses of Vioxx as well as daily doses greater than 25 milligrams.

High doses of Vioxx tripled the risk of heart attack and sudden cardiac death.

Even typical Vioxx doses, however, were more dangerous for the heart than Celebrex, the research team found.

In an e-mail sent a few hours later on Nov. 12, Galson pointed to discrepancies between the number of heart attacks and sudden cardiac deaths in an earlier paper vs. the Lancet manuscript.

The earlier paper attributed 5 cases of heart attack and sudden cardiac death to high doses of Vioxx.

The Lancet draft paper raised that to 10 cases.

"As these changes could affect the interpretation of the study, it would seem to be important to determine, before publication, whether these changes were made as part of a pre-specified process, who was involved in making the decisions, and when these new cases were added,'' Galson wrote.

In addition, the Lancet draft gave slightly different findings for such anti-inflammatories as naproxen and ibuprofen.

Galson's e-mail to Horton said the agency "would be happy'' to submit its concerns as a formal letter to be published in the Lancet.

"However, I hope these issues can be resolved without making that necessary.''

Kaiser's David Campen, one of the paper's co-authors, said after submitting an abstract to the American College of Rheumatology that the team enlisted more researchers to examine their analysis.

The team further refined what constituted a high dose of Vioxx.

In 30 to 40 cases, Kaiser's electronic database was unclear about dose.

The research team reviewed those borderline cases one by one without knowing health outcomes to determine whether those people were taking high or typical doses of Vioxx.

Horton defended Graham's integrity and pointed to detailed responses Graham e-mailed in reply to earlier FDA questions. By Nov. 14, the Lancet editor said he was satisfied that FDA questions had been addressed.

However, with no FDA reply in hand by the noon Nov. 16 deadline, Graham withdrew the paper. - AP

More Vioxx News

A Look at E-Mail Exchange Over Vioxx

2004-11-30T18:52:00.000-08:00

A Look at E-Mail Exchange Over Vioxx

Mon Nov 29, 6:01 PM ET Health - AP

By The Associated Press

Lancet editors delayed publication of a paper by an FDA (news - web sites) whistleblower that said Vioxx tripled heart risks after government officials raised questions about its scientific integrity. A few e-mails in the exchange:

Yahoo! Health
Have questions about your health?
Find answers here.

Nov. 12: FDA reviewers "identified scientific issues with the paper," according to Dr. Steven Galson, acting director of the agency's Center for Drug Evaluation and Research. "Some of the questions involve basic data integrity. (Dr. David Graham) has declined to address these issues, and we think it's important that your readers know this."

Nov. 14: "You will not be surprised if I say that I was a little taken aback to get your call," Lancet editor Richard Horton replied from England. "It is very unusual, indeed, for a member of the employing institution of an author to contact us in the middle of the review and publication process of a manuscript. Such an intervention could easily be perceived as an improper injunction in our peer review process."

Horton went on to defend Graham, the whistleblower, and said he was satisfied FDA concerns were sufficiently addressed to publish the manuscript.

Nov. 14: Galson replied, "I do think the best way to address the difficult issues surrounding these drugs is by open scientific discussion and look forward to publication of the paper because it will contribute to that discussion."

At 5:22 p.m. on Nov. 15: Graham e-mailed Galson and two other FDA superiors to ask whether the manuscript had been cleared for publication.

At 6:17 p.m. on Nov. 15: Graham rephrased his question to Galson: "In thinking about this more, and so I have clarity, if I don't hear back from you by noon tomorrow, I'll assume that I can rely on your statements to Dr. Horton, that the manuscript is cleared, and that I'm not engaging in any misconduct by allowing the paper to be published...."

At 6:46 p.m. on Nov. 15: Galson replied: "David, I have been working all day and most of the weekend on another issue and am not able to go through all this in detail." Galson named two other FDA officials to contact.

At 7:38 p.m. on Nov. 15: Graham forwarded the e-mail and a summary to those two officials.

Nov. 16, Noon: Lancet deadline for go or no-go decision by FDA.

Nov. 17: Proposed publication date for Graham paper on the Lancet web site.

Nov. 18: Graham testifies before Congress that FDA problems leave America virtually defenseless against the next Vioxx debacle.

Vioxx E-Mail Exchange Shows Questions

2004-11-30T18:41:00.000-08:00

Vioxx E-Mail Exchange Shows Questions

Mon Nov 29, 5:59 PM ET Health - AP

By DIEDTRA HENDERSON, AP Science Writer

WASHINGTON - Government questions about "basic data integrity" derailed publication of a report raising safety concerns about arthritis drug Vioxx on the eve of a contentious congressional hearing, according to an e-mail exchange.

delayed 20 mins - disclaimer
Data provided by Reuters

Without a clear agency go-ahead, Food and Drug Administration (news - web sites) safety reviewer David Graham withdrew the paper from consideration for publication in The Lancet medical journal. The paper said high doses of Vioxx tripled the risk of heart problems compared with a rival painkiller.

The whistleblower told Congress on Nov. 18 that drug regulators fumbled on safety with Vioxx. Graham said the dysfunctional agency left America virtually defenseless against the next Vioxx debacle and he named five other problematic drugs on the market.

The Lancet's editor, Richard Horton, had already pointed to "lethal weaknesses" in FDA (news - web sites)'s regulatory oversight regarding Vioxx in a scathing editorial published in early November.

Graham's paper was a peer-reviewed version of research he presented this summer in France. It would have noted that heart attacks and sudden cardiac deaths were higher among Kaiser Permanente patients taking high or low-dose Vioxx, compared with Celebrex.

The FDA said Monday it didn't try to thwart publication of the article, but at the same time noted that Vioxx already had been withdrawn from the market. Merck & Co. cited an increased risk of heart attack and stroke when it pulled the drug Sept. 30.

According to the e-mails, FDA superiors peppered Horton with last-minute concerns about the article's scientific accuracy. USA Today published a story on the exchange Monday.

"You will not be surprised if I say that I was a little taken aback to get your call," Horton replied by e-mail from England. "It is very unusual, indeed, for a member of the employing institution of an author to contact us in the middle of the review and publication process of a manuscript. Such an intervention could easily be perceived as an improper injunction in our peer review process."

FDA reviewers "identified scientific issues with the paper," Dr. Steven Galson, acting director of the agency's Center for Drug Evaluation and Research, wrote Horton on Nov. 12. "Some of the questions involve basic data integrity. (Graham) has declined to address these issues, and we think it's important that your readers know this."

Graham's study examined the records of 1.4 million Kaiser Permanente patients taking typical doses of Vioxx as well as daily doses greater than 25 milligrams. High doses of Vioxx tripled the risk of heart attack and sudden cardiac death. Even typical Vioxx doses, however, were more dangerous for the heart than Celebrex, the research team found.

In an e-mail sent a few hours later on Nov. 12, Galson pointed to discrepancies between the number of heart attacks and sudden cardiac deaths in an earlier paper vs. the Lancet manuscript. The earlier paper attributed 5 cases of heart attack and sudden cardiac death to high doses of Vioxx. The Lancet draft paper raised that to 10 cases.

"As these changes could affect the interpretation of the study, it would seem to be important to determine, before publication, whether these changes were made as part of a pre-specified process, who was involved in making the decisions, and when these new cases were added," Galson wrote.

In addition, the Lancet draft gave slightly different findings for such anti-inflammatories as naproxen and ibuprofen.

Galson's e-mail to Horton said the agency "would be happy" to submit its concerns as a formal letter to be published in the Lancet. "However, I hope these issues can be resolved without making that necessary."

Kaiser's David Campen, one of the paper's co-authors, said after submitting an abstract to the American College of Rheumatology that the team enlisted more researchers to examine their analysis. The team further refined what constituted a high dose of Vioxx.

In 30 to 40 cases, Kaiser's electronic database was unclear about dose. The research team reviewed those borderline cases one by one without knowing health outcomes to determine whether those people were taking high or typical doses of Vioxx.

Horton defended Graham's integrity and pointed to detailed responses Graham e-mailed in reply to earlier FDA questions. By Nov. 14, the Lancet editor said he was satisfied that FDA questions had been addressed.

However, with no FDA reply in hand by the noon Nov. 16 deadline, Graham withdrew the paper.

FDA Interfered With Vioxx Article Publication

2004-11-30T18:38:00.000-08:00

Here are some of the latest health and medical news developments, compiled by editors of HealthDay:

FDA Interfered With Vioxx Article Publication: Report

An official from the U.S. Food and Drug Administration took the unusual step of calling a medical journal's editor to question the legitimacy of an article critical of the now-defunct painkiller Vioxx, only days before the article was to run, USA Today reported Monday.

The article, written by Dr. David Graham of the FDA's Office of Drug Safety, was to have run in the British medical journal The Lancet. Graham alleges that the call to the journal by Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research, was an attempt to block the article's publication, USA Today reported.

Galson said his call was an attempt only to point out that Graham's article had been submitted to the journal in violation of the FDA's clearance process, the newspaper reported, since agency superiors said they had not approved Graham's article. A statement by acting FDA Commissioner Lester Crawford said Galson contacted journal editor Richard Horton "out of respect for the scientific review process," USA Today said.

Graham's article cited an analysis of some 1.4 million Kaiser Permanente members showing that those who took Vioxx were more likely to suffer a heart attack or sudden cardiac death than those who took Celebrex, a competing painkiller. The article was to have been published on the journal's Web site on Nov. 17, but Graham told the newspaper he ultimately withdrew it for fear of losing his job.

Merck & Co., Inc., pulled Vioxx from the market in late September, citing its own data that users had an increased risk of heart attack and stroke.

Merck Sued by New York Fund Over Vioxx

2004-11-30T18:29:00.000-08:00

NEW YORK - The New York state comptroller sued Merck & Co., claiming the drug maker hid certain risks associated with the painkiller Vioxx.

Data provided by Reuters
--------------------------------------------------------------------------------

Merck pulled its Vioxx pain medication from shelves Sept. 30 after a clinical trial showed patients taking the drug showed an increased risk for heart attacks and strokes after 18 months. The move came after several physicians and other studies raised concerns about the drug's potential health risks.

The company has been the subject of several investor lawsuits since it pulled Vioxx off the market, mostly because its stock has lost well over a third of its value since the recall. One of the losers has been New York state's pension fund, which has recorded $171 million in paper losses related to Merck, according to state Comptroller Alan G. Hevesi.

The majority of the state's Merck stock was held by the pension fund in an internally managed index fund. As of Sept. 30, the fund held a total of 9.4 million Merck shares, with 7.8 million in the index account, according to a spokesman for the New York comptroller.

Mr. Hevesi filed a suit against the Whitehouse Station, N.J., company seeking class-action status in a federal district court in New Jersey, as well as related federal motions in Louisiana. He also is seeking to consolidate all other purported class actions into one case in New Jersey.

Tony Plohoros, a Merck spokesman, said the company couldn't comment on the specific allegations in the lawsuit because it hadn't seen it.

"We promptly disclosed the clinical data about Vioxx," Mr. Plohoros said.

Mr. Hevesi has been considered an activist comptroller, filing suits against a number of companies, including Bayer AG; WorldCom, now called MCI Inc.; McKesson Corp.; Raytheon Co.; and Cendant Corp.

The comptroller's suit against Merck is similar to the one filed in 2003 against German drug and chemicals maker Bayer. The Bayer suit, which still is pending, centered on Baycol, a cholesterol-lowering drug that was pulled from the market in 2001 amid safety concerns. That suit claims Bayer had knowledge about problems with Baycol that it didn't disclose.