Federal Panel Consolidates Vioxx Suits

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The New York Times
February 17, 2005
By BARNABY J. FEDER

Hundreds of individual and class-action lawsuits filed in federal courts against Merck, blaming its painkiller Vioxx for deaths and injuries, will be consolidated in a federal court in New Orleans before a judge that many plaintiffs' lawyers had hoped would receive the case.

The consolidation order that funneled the cases to Judge Eldon E. Fallon, 66, was issued yesterday by a seven-member administrative body of federal judges that rules on motions to centralize nationwide legal battles.

Lawyers for plaintiffs and the company presented their arguments late last month to the seven-judge panel, with both sides agreeing that the growing number of cases made consolidation desirable. Merck had asked that the cases be consolidated in a federal court in Illinois, Indiana or Maryland, but the court in Louisiana emerged as a favorite among the plaintiffs' lawyers.

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The New York Times
February 17, 2005
By GARDINER HARRIS


GAITHERSBURG, Md., Feb. 16 - A panel of federal drug advisers who gathered here on Wednesday to judge the safety of the heavy-selling pain pills Celebrex, Bextra and Vioxx were tough, sometimes even caustic, in their remarks about the drugs, suggesting that the panel may take a hard line on their uses.

One panel member accused Pfizer of hiding data. Another asked a Pfizer researcher if she would take Bextra if she had heart risks. Dr. Karen Seibert, the Pfizer researcher, declined to answer. Dr. Vibeke Strand, an arthritis specialist from Stanford University who consults for Pfizer, then stepped to the microphone.

"Would I recommend that a patient with high cardiovascular risk take these products?" she asked. "I think the answer would be no."

The panel was convened by the Food and Drug Administration after Merck announced in September that it would withdraw Vioxx from the market because a study had found that the medicine doubled the risks of heart attacks and strokes.

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Pardon Christopher Pittman

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Drug Awareness Message
www.drugawareness.org
February 15,2005

Christopher Pittman, 12, was under the influence of Zoloft which prevented him from knowing right from wrong when he shot his grandparents dead and set their house on fire. Now, three years later, with LOTS of help given to the prosecution by Pfizer, the makers of Zoloft, Christopher has been convicted of murder and given 30 years.

(You can find more on Christopher's case posted on the web site of Vickery & Waldner, LLP, the law firm defending Christopher, at: www.justiceseekers.com.)

The family and all those involved in this case want to thank you for your prayers in Christopher's behalf. Now we ask all of you to please write letters to the governor of South Carolina and President George Bush asking that they issue a pardon for this child. The addresses are listed below:

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Wed Feb 16, 2005 04:07 PM ET
By Lisa Richwine

GAITHERSBURG, Md. (Reuters) - The heart attack and stroke risks linked to withdrawn arthritis drug Vioxx are an inherent problem for similar pain pills, Vioxx maker Merck & Co. Inc. told advisers to the U.S. Food and Drug Administration on Wednesday.

Merck voluntarily withdrew Vioxx in September after a study showed the drug doubled the risk of heart attack and stroke in patients who took it for at least 18 months.

Since the Vioxx recall, questions have arisen about similar pain pills from Pfizer Inc., Celebrex and Bextra, as well as non-prescription drugs such as naproxen.

The FDA is asking two outside advisory committees if Celebrex and Bextra offer enough benefits to stay on the market, if any pain relievers need stronger warnings and what further research is needed. The advisers are due to meet through Friday.

Studies "strongly suggest" the entire class of drugs called COX-2 inhibitors elevate the chances of cardiovascular problems, Dr. Ned Braunstein, senior director of Merck Research Laboratories, told the panel of FDA advisers.

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Air Pollution Damages Babies in Womb -Study

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Tue Feb 15, 2005 4:10 PM ET

WASHINGTON (Reuters) - Babies' DNA can be damaged even before they are born if their mothers breathe polluted air, according to a study published on Tuesday.

"This is the first study to show that environmental exposures to specific combustion pollutants during pregnancy can result in chromosomal abnormalities in fetal tissues," said Kenneth Olden, director of the National Institute of Environmental Health Sciences, which funded the study.

"These findings may lead to new approaches for the prevention of certain cancers."

The team at the Columbia University Center for Children's Environmental Health in New York studied 60 newborns for the report, published in the February issue of the journal Cancer Epidemiology Biomarkers and Prevention.

As part of a larger study, they monitored the babies' exposure to polycyclicaromatic hydrocarbons, which are compounds produced by burning.

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Pain Killers Face Review for Heart Risks

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Wed Feb 16, 2005 7:14 AM ET
By Lisa Richwine

WASHINGTON (Reuters) - Medicines used by millions of Americans to relieve aches and pains will come under intense scrutiny starting Wednesday as U.S. scientists scour dozens of studies to determine if the drugs risk damaging the heart like Merck & Co. Inc.'s withdrawn arthritis pill Vioxx.

The unusual three-day public review was prompted by Merck's recall of Vioxx in September after a study showed the drug doubled heart attack and stroke risk in patients who took it for at least 18 months.

Since then, questions have arisen about Pfizer Inc.'s similar pain pills, Celebrex and Bextra, as well as nonprescription therapies such as naproxen.

The Food and Drug Administration is asking two outside advisory committees if Celebrex and Bextra offer enough benefits to stay on the market, if any pain relievers need stronger warnings and what further research is needed.

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Flu Shots May Not Save Lives

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Reuters Health
Mon Feb 14, 2005 4:03 PM ET


CHICAGO (Reuters) - The flu vaccinations that doctors hoped would save the lives of fragile elderly people have apparently failed to lower death rates, U.S. researchers said on Monday.

More people whose health could be put at risk by influenza have heeded the call to get vaccinated before flu season, but the death rate during the winter flu season remained the same rather than declining, they said.

Based on U.S. mortality rates from 1968 to 2001, the study by the National Institute of Allergy and Infectious Diseases found no correlation between increasing vaccination rates after 1980 and declining death rates in any age group.

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Seth Hettena
Associated Press
Feb. 13, 2005 12:00 AM

SAN DIEGO - As a volunteer firefighter, Georg-Andreas Pogany had seen disfigured bodies pulled from wrecked cars, but something different happened when the Army interrogator saw the mangled remains of an Iraqi soldier.

He became panicked, disoriented and that night reached for his loaded pistol and rifle as he thought he saw the enemy bursting into his room. Pogany asked superiors for help; the Army packed him home to face charges of cowardice, the first such case since Vietnam.

None of it made sense to Pogany until he learned more about the white pills the Army gave him each week to prevent malaria. The drug's manufacturer warned of rare but severe side effects including paranoia and hallucinations.

Pogany is among the current or former troops sent to Iraq who claim that Lariam, the commercial name for the anti-malarial drug mefloquine, provoked disturbing and dangerous behavior. The families of some troops blame the drug for the suicides of their loved ones.

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Merck's Actions on Vioxx Face New Scrutiny

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The New York Times
February 15, 2005
By BARNABY J. FEDER


The spotlight is likely to be on Pfizer tomorrow when federal drug regulators begin hearings on cox-2 drugs, the class of arthritis and pain medicines that include the company's Celebrex and Bextra brands. After all, Merck, which made the other drug in that class, Vioxx, pulled it off the market last fall, citing its safety risks.

But Wall Street analysts and battalions of lawyers will be intently watching testimony by and about Merck because the company faces hundreds of lawsuits over Vioxx, some of them scheduled to go to trial as early as May in Alabama and Texas. Consolidated groups of cases are headed for trial in California and New Jersey this summer.

The three days of hearings by an advisory panel to the Food and Drug Administration are expected to include extensive testimony about how Merck and the federal agency dealt with safety concerns about Vioxx in the years and months before the company withdrew the drug.

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More concerns over arthritis drugs

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BBC News UK Edition
15 February, 2005

Arthritis drugs which have been linked with heart attacks and strokes raise blood pressure more than other painkillers, Australian scientists say.

Concerns over one of the class of drugs known as COX-2 inhibitors - Vioxx - led to it being withdrawn by its maker.

And European regulators are conducting a safety review of COX-2 inhibitors - used by up to 1m people in the UK.

The latest study, which looked at 19 trials involving 45,000 people, is in the Archives of Internal Medicine.


The COX-2 story
September 2004 - Vioxx withdrawn from market
December 2004 - data raises concerns about another COX-2 inhibitor called Celecoxib
January 2005 - European regulators review the safety of the COX-2 class of drugs


Blood pressure
Compared with other painkillers called non-steroidal anti-inflammatory drugs (NSAIDs) and dummy drugs, COX-2 inhibitors caused increases in blood pressure that the authors believe is concerning.

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