Drug Injury Watch

First N.J. Vioxx Trial Involving Long-term Use Draws To An End

Will Jury Verdict Be For Plaintiffs Cona And McDarby, or Defendant Merck?

The first two Vioxx cases in New Jersey involving long-term Vioxx use, Cona v. Merck and McDarby v. Merck, may have a jury verdict as early as the first week of April 2006. 

Closing arguments are scheduled to take place in an Atlantic County, NJ courtroom on April 3, 2006, when lawyers for the two plaintiffs and the drug company will talk one last time to the jury about the factual evidence presented during the month-long trial.  Thereafter, Superior Court Judge Carol Higbee will provide the jury instructions that establish the legal standards to be used by the jurors (six women and two men) as they deliberate the issue of whether Merck should be held liable for the heart attacks suffered by Mr. Cona and Mr. McDarby while using Vioxx.

Dr. Margaret Harbison, a psychiatrist who treated plaintiff Thomas Cona for about four years beginning in August 2000, was the final witness put on by Merck's lawyers. Dr. Harbison's testimony was intended to counter earlier testimony from Mr. Cona's daughter that her father was weak and unable to participate in family activities after his June 2003 heart attack. In summary, Dr. Harbison testified that Mr. Cona never mentioned taking Vioxx, neither before nor after his heart attack, and that just three months after his heart attack Mr. Cona said he was "feeling good" and playing golf again.

Under cross-examination by Mr. Cona's lawyer, however, Dr. Harbison admitted that the doctors who were treating Mr. Cona for his heart attack -- which doctors were not called to testify as part of Mercks' defense case -- would likely have better information about Mr. Cona's Vioxx use, and his physical condition following the heart attack in 2003.

Here is a quick re-cap of this Vioxx trial prior to Dr. Harbison's being called as the final witness:

• Lawyers for plaintiffs Thomas Cona and John McDarby called 14 witnesses to present their respective cases.
• Merck's lawyers called only five witnesses: two company scientists; two cardiologists; and, as mentioned above, Mr. Cona's psychiatrist.
• The essence of the two plaintiffs' cases was that Merck knew Vioxx caused an increased risk of heart attacks long before it recalled Vioxx, but did not warn doctors and patients because the drug company wrongfully placed profits over safety.
• The theme of Merck's defense was that the drug company acted responsibly as regards Vioxx, and that it was the men's pre-existing medical conditions, not Merck's Vioxx, that were to blame for their heart attacks.

A March 30, 2006 article by Reuters succinctly captured the positions of both sides as these two Vioxx cases go to the jury in New Jersey next week:

" 'I think the evidence has showed that Merck acted responsibly in testing the medication before it was approved for market and continued to test the medicine after approval and that all the information was shared with the FDA,' Merck spokesman Chuck Harrell said outside the courtroom."

"Asked for a comment as the trial drew to a close, [Mr. Cona's lawyer, Mark Lanier] said, 'I'd rather be sitting in my chair than Merck's.' "

Vioxx was pulled off the market in September 2004.  To date, more than 9,650 lawsuits concerning Vioxx have been filed against Merck in the U.S.  The consensus seems to be that the two verdicts in this first New Jersey trial involving long-term Vioxx use will have a significant impact on the Vioxx litigation overall, going forward.

(Posted by: Tom Lamb)

Whistleblower David Graham Discusses Problems With The FDA

In-depth Interview Of This Top FDA Insider From 2005, In Seven Parts

In August and September 2005 Dr. Joseph Mercola -- an osteopathic physician, also known as a DO -- published on his web site a seven-part interview series with the FDA's David Graham which did not receive the degree of attention it rightfully deserved.

It seems that this series of David Graham interviews was first published by Crusador, which has been described as "a hard-hitting, in-depth health publication that cuts through the health lies that are so prevalent in our world today".

As background, Dr. David Graham's November 2004 Senate testimony about the FDA's failures as regards the Vioxx debacle put him on the front page and in the nightly news.  But Dr. Graham is no flash-in-the-pan when it comes to drug-safety issues.  For example, Dr. Graham helped write the Grassley-Dodd bill that was introduced in the spring of 2005, but apparently stalled at the legislative committee level in Washington since then.  The Grassley-Dodd bill would help strengthen the FDA's drug-safety efforts, in part, by establishing a new independent department within the FDA to review serious side effects associated with prescription drugs after they have been approved by the agency and are being marketed in the U.S.

In this seven-part interview, Dr. David Graham tells us why he thinks there needs to be legislative changes made to the FDA -- such as the Grassley-Dodd bill -- in order for that agency to be able to adequately protect American patients from adverse reactions due to use of unsafe drugs.

Manette Loudon conducted this seven-part series of interviews with Dr. David Graham, which starts as follows:

Loudon: Dr. Graham, it's truly a pleasure to have the opportunity to interview you. Let me begin by asking you how long you've been with the FDA and what your current position is?

Dr. David Graham: I've been with the FDA for 20 years. I'm currently the Associate Director for Science and Medicine in the Office of Drug Safety. That's my official job. But when I'm here today I'm speaking in my private capacity on my own time, and I do not represent the FDA.

We can be pretty certain that the FDA would not agree with most of what I have to say. So with those disclaimers, you know everything is OK.

We encourage you to read this 2005 interview with Dr. David Graham, of the FDA.

(Posted by: Tom Lamb)

California Vioxx Cases: First Vioxx Trial To Start In June 2006

Will Judge Chaney Schedule A Single Plaintiff Case Or Multiple Plaintiffs Case?

The first Vioxx trial in California is scheduled to start on June 21, 2006, but it is still unknown whether the jury sitting for that case will be hearing about a single individual or several individuals who suffered a heart attack after taking Vioxx.

As of March 20, 2006, Los Angeles Superior Court Judge Victoria Chaney is presiding over 1,882 Vioxx lawsuits that have been filed in California against Merck & Co. Inc. The California Vioxx lawsuits are among the more than 9,650 Vioxx lawsuits filed since September 2004, when Merck voluntarily removed Vioxx from the market.

Judge Chaney recently identified 36 potential cases that could be the subject of the first California Vioxx trial.  From this list of 36 cases we know that the jury will be hearing about an alleged Vioxx-induced myocardial infarction, or heart attack. What remains uncertain is whether the jury sitting for the June 21 California trial will be hearing about a heart attack suffered by a single patient after taking Vioxx, or the cases of two or more people who allege that Vioxx caused their heart attack.  See In re Vioxx Coordinated Cases, No. JCCP 4247 (Los Angeles Co., Calif., Super. Ct.).

According to an article in the March 27, 2006 edition of The National Law Journal, plaintiffs lawyers have encouraged Judge Chaney to schedule two or more Vioxx cases for the June 21, 2006 trial because the liability facts, at least, of these Vioxx-induced heart attack cases are very similar.  Further, the article reports that many of the same experts will be involved in these California Vioxx cases

The March 2006 National Law Journal article also reports the position of Merck on the issue of single plaintiff versus multiple plaintiffs.  Ralph Campillo, reported to be the lead defense attorney for Merck as regards the California state court Vioxx cases, told a National Law Journal reporter that Merck prefers the single plaintiff case approach.

"[Mr. Campillo] said that specific facts of the case -- such as the plaintiff's medical history, the physician's knowledge of the harmful effects of Vioxx and the time frame in which each patient took the drug -- could confuse the jury."

Mr. Campillo is a partner in the Los Angeles office of Sedgwick, Detert, Moran & Arnold.

Meanwhile, according to this National Law Journal article, Judge Chaney is still weighing her options:

"I want to know more about the cases we're going to try, their similarities and dissimilarities," she told a packed courtroom of about 25 lawyers. "I need to know if it's best to do single or multiple."

We will keep you posted on developments in the California state court Vioxx litigation.

(Posted by: Tom Lamb)

Ortho Evra MDL Cases Assigned to Federal Court Judge Katz in Ohio

Lawsuits Allege Birth Control Patch Causes Harmful Blood Clots

On March 1, 2006 U.S. District Judge David A. Katz, of the Northern District of Ohio, was selected to oversee the federal court Ortho Evra Multidistrict Litigation (MDL).  See In re Ortho Evra Products Liability Litigation, No. MDL-1742, 2006 WL 538724, transfer order issued (J.P.M.L. Mar. 1, 2006). 

Judge Katz, who holds court in Toledo, Ohio, is already handling the first federal court lawsuit filed concerning an injury caused by the birth control skin patch called Ortho Evra; that case is called Bernard v. Ortho-McNeil Pharmaceuticals.  With this MDL assignment, Judge Katz is now in charge of overseeing consolidated pretrial proceedings in all of the current 67 federal court lawsuits that have been filed against Ortho-McNeil regarding its Ortho Evra contraceptive patch.

These Ortho Evra cases generally allege that the Ortho Evra patch was defectively designed.  Furthermore, plaintiffs allege that Ortho-McNeil inadequately warned doctors and patients of harmful blood clots -- possibly resulting in pulmonary embolisms, heart attacks, and strokes -- that have been associated with use of the Ortho Evra birth control patch.  The typical lawsuit includes various different legal liability theories such as negligence, breach of warranty, and misrepresentation regarding the risks of serious side effects.  Late in 2005, a motion was filed with the Judicial Panel on Multidistrict Litigation (JPML) by a plaintiff's lawyer requesting the consolidation of all federal court lawsuits alleging injury or death due to use of the Ortho Evra birth control patch.

The Ortho Evra skin patch combines a progestin, norelgestromin, and an estrogen, ethinyl estradiol, in a transdermal delivery system.  Based on reports made to the FDA MedWatch program, the Ortho Evra patch has been linked to an increased risk of pulmonary embolism, heart attack, and stroke in women, especially those who smoke cigarettes or who are more than 35 years-old.

In November 2005 the FDA ordered Ortho-McNeil to put a bolded warning on the Ortho Evra label, or package insert, to inform doctors and patients that the Ortho Evra patch exposes users to estrogen levels some 60 percent greater than found in a typical oral contraceptive, or birth control pill. In turn, it is this increased dosage of estrogen that is associated with the increased risk of developing harmful blood clots.

(Posted by: Tom Lamb)

Concern Expressed About Heart Risks From Adderall, Ritalin, Other ADHD Drugs

Early Release of Dr. Nissen's NEJM Article: "ADHD Drugs and Cardiovascular Risks"

Cardiologist Steven E. Nissen believes that Shire Plc's Adderall, Novartis AG's Ritalin, and other drugs used to treat attention deficit-hyperactivity disorder (ADHD) may cause potential risks to the heart, and that these risks should be set forth in a "black-box" warning to heighten the awareness of doctors and patients.  Dr. Nissen is the interim chair of cardiology at the Cleveland Clinic and president of the American College of Cardiology.

On March 20, 2006 The New England Journal of Medicine (NEJM) published on its web site an "early-release" version of a "Perspective" article written by Dr. Nissen entitled "ADHD Drugs and Cardiovascular Risk".  This article, which will appear in the April 6, 2006 edition of the NEJM, takes us through the thought process that led Dr. Nissen to introduce his black-box warning motion at the February 9, 2006 meeting of the FDA's Drug Safety and Risk Management Advisory Committee.  This 15-member panel of experts voted 8 to 7 in support of Dr. Nissen's motion and, thereby, recommended a black-box warning be put on the respective labels, or package inserts, to describe the cardiovascular risks of stimulant drugs like Adderall and Ritalin used to treat ADHD.

Likely not by coincidence, the early release of Dr. Nissen's NEJM article on March 20 came just two days before the FDA convened an advisory panel of pediatricians which will consider the safety of drugs like Ritalin and Adderall. This FDA advisory panel is set to review data on a possible link between the ADHD drugs and cardiovascular problems like heart attacks and strokes, as well as psychiatric problems such as hallucinations and psychosis.

As background, the advisory panel of drug safety experts that met in February 2006 had been asked by the FDA to assist the agency in deciding what kinds of studies needed to be done to further study the side effects associated with Adderall, Ritalin, and the other ADHD drugs.  Dr. Nissen suggested that while further studies were warranted, something else was needed immediately -- a black-box warning about the reports of heart attacks, strokes, and sudden unexplained death (SUD) in children and adults that had been submitted to the FDA's MedWatch program.

According to a March 21, 2006 article by Matthew Herper published by Forbes:

"That's not the wrong thing to do," [Dr. Nissen] said in February. "I don't care what their benefits are." Nissen says he is proposing a new regulatory standard: That patients should be warned if there is a high level of suspicion that a drug might be dangerous, instead of waiting for definitive proof. "I am convinced we need to warn earlier and then back off the warnings if the drugs prove safe," he says.

The FDA, however, has said several times since the February 2006 meeting -- when Dr. Nissen's black-box warning motion was narrowly passed -- that the agency would wait to hear from this second advisory panel before deciding whether to strengthen or update warnings on the ADHD drug labels.

At the February 2006 advisory panel meeting, there was testimony presented that 2.5 million children currently take one of the ADHD drugs, including almost 10% of ten-year-old boys. Furthermore, 1.5 million adults take ADHD drugs, with a remarkable 10% over the age of 50.

While most concern to date has been focused on the children, for Dr. Nissen it is older users of ADHD drugs that he is particularly worried about as regards the risks of heart attacks and strokes. The substantial increases in heart rate and blood pressure caused by use of ADHD drugs, particularly during long-term therapy as seen in these adults, are known generally to increase morbidity and mortality.

(Posted by: Tom Lamb)

Vioxx: VIGOR Study Article: NEJM - Merck Controversy Continues

Study Authors Defend Their Research But NEJM Editors Are Not Convinced
   

In the March 16, 2006 edition of The New England Journal of Medicine (NEJM) are two letters by authors of the now infamous Vioxx Gastrointestinal Outcomes (VIGOR) study article that was published by the NEJM in 2000.  The letters are intended to reinforce the integrity of their VIGOR research.  In the same edition, however, is an editorial by Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D. which is essentially a reaffirmation of the NEJM editors' December 2005 "Expression of Concern".

Thus continues the controversy between Merck and the NEJM about the timing of Merck's disclosure of cardiovascular events linked to Vioxx that occurred in the VIGOR study but were not part of the original VIGOR study article published by the NEJM in 2000.

The first letter to the editor in support of the VIGOR study is written by Claire Bombardier, M.D., who was a lead author of the VIGOR study, and ten of her colleagues who are not Merck employees.  Dr. Bombardier and her colleagues contend that they did not deliberately omit from the VIGOR study article data concerning three additional heart attacks that occurred in the Vioxx treatment group.  Dr. Bombardier and colleagues state that, based on their review of the VIGOR data after the December 2005 "Expression of Concern" was published in by the NEJM, "our original article followed appropriate clinical trial principles and does not require a correction."

This is followed by the second letter to the editor, which was written by two researchers involved with the VIGOR study who are Merck employees, Alise Reicin, M.D., and Deborah Shapiro Dr.P.H.  They defend the original VIGOR study article, also, emphasizing the propriety of scientific analysis and presentation of data, as well as Merck's prompt disclosure of the three additional heart attacks that occurred in the Vioxx treatment group to the FDA.

The NEJM editors replied to these two letters by means of a new editorial about Merck and Vioxx, wherein they indicated that the explanations offered by the VIGOR researchers may have been technically correct but were essentially disingenuous. Fundamentally, the NEJM editors allege that the conclusions in the original Vioxx study article did not reflect a spirit of efficacy and safety.

As background, VIGOR was a double-blind, randomized outcomes study of upper gastrointestinal events that involved 8,000 arthritis patients taking either 50 mg of Vioxx 50mg or naproxen 500mg twice a day.  Vioxx is a COX-2 inhibitor.

Merck withdrew Vioxx from the market in September 2004 after it released data from another Vioxx study which suggested that Vioxx increased the risk of having a heart attack or stroke in patients who had taken Vioxx daily for 18 months or longer.

(Posted by: Tom Lamb)

Drug Safety Oversight Board Needs Improvements, Says Leading FDA Adviser

Chairman Dr. Peter Gross Suggests Two Changes: Open Meetings And Public Representatives

In mid-February 2006 Dr. Peter Gross, the outgoing chairman of the FDA's drug-safety and risk-management advisory committee, said that the agency's relatively new Drug Safety Oversight Board should make some changes to improve its public perception.  Dr. Gross, who is also chairman of the internal-medicine department at Hackensack University Medical Center in New Jersey, said specifically that the FDA should consider adding some outside experts to this advisory board.

At present, the FDA's Drug Safety Oversight Board members are all federal government employees: senior FDA officials together with representatives from the National Institutes of Health and the Department of Veterans Affairs.

The FDA established the Drug Safety Oversight Board in 2005, seemingly as a response to widespread criticism that the agency was slow in reacting to drug-safety issues such as the Vioxx debacle.  This board is suppose to help the FDA to move more quickly when the agency learns of unexpected side effects after it has approved a prescription drug for use in the U.S.

A February 13, 2006 article published by Reuters succinctly states Dr. Gross' case:

"You are setting yourself up for failure with this oversight board," Gross told FDA officials at a meeting of the advisory panel. "In this age of transparency, you decide to have a committee that's responsible, according to its name, for overall safety, and yet it meets in private. You don't have public representatives."

Dr. Gross commented, also, that the name of the oversight board is "misleading to the public", and implies that it is the sole government entity that makes drug-safety decisions. 

The FDA's retort to the points raised by Dr. Gross was presented by Dr. Sandra Kweder, deputy director of the FDA's office of new drugs.  According to several news reports in February 2006, Dr. Kweder stressed that the Drug Safety Oversight Board is an internal board that was not meant to replace any use of drug-safety advisory panels, which usually involve "outside" medical experts. Dr. Kweder pointed out that new legislation would be needed in order to add those outside medical experts as "public" members of this board.

Furthermore, the FDA has maintained that Drug Safety Oversight Board was designed specifically to be an internal management group, in part because at times this board must discuss confidential company information.

(Posted by: Tom Lamb)

FDA Review Team: Stronger Warnings About Psychosis And Mania Needed On ADHD Drugs

Reports Of Hallucinations At Usual Doses Of Adderall, Concerta, Ritalin, and Strattera

The FDA's ADHD psychiatric review team is calling for stronger warnings on drugs used to treat attention deficit hyperactivity disorder (ADHD) to make doctors and patients more aware about psychosis or mania events associated with the use of ADHD drugs at usual dose levels.

In mid-March 2006 the FDA posted on its web site an updated safety review of several ADHD drugs, including Johnson & Johnson's Concerta, Shire Pharmaceuticals Group PLC's Adderall, Eli Lilly & Co.'s Strattera, and Novartis AG's Ritalin.  Essentially, the FDA takes the position that stronger warnings are needed on these ADHD drugs to heighten awareness about the risk of psychosis, which is a mental disorder characterized by the inability to distinguish real and imaginary events.

The FDA's March 2006 updated safety review for ADHD drugs reports that almost 1,000 cases of psychosis or mania possibly related to use of the drugs -- which include Adderall, Concerta, Ritalin, and Strattera -- were received by the FDA's MedWatch program during the period January 1, 2000 to June 30, 2005.  The safety review points out that these MedWatch reports do not necessarily mean any of the ADHD drugs caused the psychosis or mania events, but observed that "in many patients the events resolved after stopping the drug."

A March 3, 2006 memo written by two members of the FDA's ADHD psychiatric review team set forth some of the leading drug-safety issues for these ADHD drugs:

• "The most important finding of this review is that signs of psychosis or mania, particularly hallucinations, can occur in patients with no identifiable risk factors, at usual doses of any of the drugs used to treat ADHD."
• The current labels, or package inserts, for these ADHD medications neither adequately address these psychiatric risks nor do they "clearly state the importance of stopping drug therapy in any patient who develops hallucinations or other signs or symptoms of psychosis or mania during drug treatment of ADHD."
• Remarkably, a "substantial portion of the psychosis-related cases were reported to occur in children 10 years or less," an age group which does not typically suffer from psychosis. "The predominance in young children of hallucinations, both visual and tactile, involving insects, snakes and worms is striking and deserves further evaluation."

While the FDA staff who conducted the updated safety review recommended that the risk of psychosis and mania events be addressed by a stronger warning in the respective labels, or package inserts, they did not state whether it should be in the form of a "black-box" warning.

The FDA’s Pediatric Advisory Committee will address these psychosis and mania events, as well as cardiovascular events possibly related to ADHD medications, at a March 22, 2006 meeting.  According to a March 15, 2006 article in The Wall Street Journal, this committee has received a memo from Dianne Murphy, the FDA's director of the Office of Pediatric Therapeutics, informing them of their mission: "[The FDA is] seeking your advice on how best to communicate potential risks to health care providers and parents when it has been decided a child would benefit from therapy for attention deficit hyperactivity disorder."

(Posted by: Tom Lamb)

Health Canada Issues Pregnancy Warning For Antidepressants

Newborns Whose Mothers Took SSRIs At Increased Risk Of Serious Lung Disorder

On March 10, 2006 Health Canada issued a warning for women taking antidepressant drugs known as Selective Serotonin Re-uptake Inhibitors (SSRIs) -- including Prozac and Paxil -- and who are pregnant or thinking of becoming pregnant.

Health Canada issued this advisory to draw attention to a recent study published in The New England Journal of Medicine which linked Prozac, Paxil, and other drugs in the SSRI class to a rare but potentially fatal condition in newborns called persistent pulmonary hypertension.  According to the advisory, cases of persistent pulmonary hypertension have been reported in babies born to women who took SSRI antidepressants during the second half of their pregnancies.

Health Canada urged women using antidepressants in the SSRI class and who are pregnant or intend to become pregnant to immediately discuss the situation with their doctor due to the seriousness of this side effect risk to the baby.  Specifically, the March 2006 advisory provided this information about the persistent pulmonary hypertension side effect:

“Newborns with this rare but life-threatening condition [persistent pulmonary hypertension] do not receive enough oxygen in the blood and require intensive-care treatment to survive."

“According to the study, babies born with [persistent pulmonary hypertension] were six times more likely than healthy babies to have been exposed to SSRIs. This information is considered to be preliminary at this time.”

The following antidepressant drugs in the SSRI class were mentioned in this Health Canada advisory:

• Wellbutrin (bupropion);
• Celexa (citalopram);
• Cipralex (escitalopram);
• Prozac (fluoxetine);
• Luvox (fluvoxamine);
• Remeron (mirtazapine);
• Paxil (paroxetine);
• Effexor (venlafaxine); and,
• Zoloft (sertraline).

This pregnancy warning from Health Canada included, also, Zyban (bupropion), a medication prescribed for smoking cessation.

Health Canada has emphasized that women should not stop taking their antidepressant SSRI drug before first consulting with their doctor.  In providing some guidance to doctors, the Health Canada advised that a pregnant woman's use of SSRI drugs should only be continued where the doctor believes the benefits to the patient outweigh the risks to the fetus.

Lastly, the March 2006 advisory reminded women and their doctors that an increased risk of major birth defects has also been associated with the use of Paxil and other SSRI drugs.

(Posted by: Tom Lamb)

Pfizer's Painkiller Celebrex May Increase Heart Attack Risk, Like Vioxx and Bextra

New Zealand Study Indicates This Increased Risk Is "Class Effect" of COX-2 Inhibitors

Pfizer Inc.'s painkiller Celebrex doubles a patient's risk of having a heart attack, according to a report about a New Zealand study published in the Journal of the Royal Society of Medicine in the first part of 2006.

A March 1, 2006 Reuters article about the New Zealand study gave this summary:

[The researchers] looked at four trials involving 4,422 patients which compared Celebrex to a placebo. The study . . . showed [Celebrex] was associated with a 2.26 fold increased risk of a heart attack.

In six other studies, patients taking [Celebrex] had a 1.88 fold raised risk of a heart attack compared to patients taking older painkillers such as ibuprofen and paracetamol.

Richard Beasley, one of the lead researchers for the New Zealand study, said their analysis of these drug trials involving Celebrex (celecoxib) suggests this increased risk of having a heart attack is common to the entire class of drugs known as COX-2 inhibitors.

Merck & Co. Inc. withdrew Vioxx from the market in September 2004 after a study showed it doubled the risk of a stroke or heart attack in patients taking it for 18 months or more.  Thereafter, in April 2005, Pfizer voluntarily recalled Bextra due to these cardiovascular side effects as well as an increased risk of developing serious skin reactions like Stevens-Johnson Syndrome (SJS).  Due to these two drug recalls, Celebrex is the only the COX-2 inhibitor still available in the U.S.

In August 2005, however, Pfizer put a "black-box" warning on Celebrex label, or package insert, following a recommendation by the FDA, which warns that Celebrex may increase the risk of cardiovascular events, including heart attack and stroke.

In 2005, also, the European Medicines Agency (European Union's drug regulator) issued guidance about the use of COX-2 pain relievers, stating in relevant part that Celebrex should not be prescribed to people with ischemic heart disease or stroke, and when prescribed the lowest dose and shortest course of Celebrex should be used.

Returning to the March 1 article published by Reuters:

"Our evidence shows an increased risk of heart attack in patients taking [Celebrex]," said Beasley.

"Drug regulatory authorities need to urgently re-examine the assessment of [Celebrex] in light of these findings," he added in a statement.

"Given the popularity of [Celebrex] in the treatment of arthritis, drug regulators must undertake an up-to-date risk assessment based on the findings presented here," said Beasley.

A spokesman for Pfizer contested the analysis done by the New Zealand researchers in a March 1, 2006 article in The Wall Street Journal:

"The FDA, [the European Medicines Agency] and other health authorities around the world have concluded that the benefits of Celebrex continue to outweigh its risks, and, as a result, Celebrex is the only Cox-2 inhibitor remaining on the market today."

In December 2005 the Cleveland Clinic announced that it would lead an international study to learn whether painkillers taken for arthritis, including Celebrex, Ibuprofen and Naproxen, are safe for those at risk of heart problems.  The results from that study -- known as the PRECISION study -- will not be available, however, until 2010 at the earliest.

(Posted by: Tom Lamb)