From the monthly archives:

November 2008

If you or someone you know is currently taking Avandia, please read the article below for important information. If you believe you have been injured as a result of taking Avandia, please contact us immediately at 601.366.1297 or you may submit a short form for a free consultation by clicking here.

Safety risks higher with Avandia than Actos: study
Mon Nov 24, 2008 10:17pm EST

By Julie Steenhuysen

CHICAGO (Reuters) – Older diabetics who took GlaxoSmithKline’s Avandia to control their blood sugar had a higher risk of death and heart failure while on the drug than those who took Takeda Pharmaceutical’s Actos, a drug in the same class, U.S. researchers said on Monday.

They said the head-to-head comparison confirms prior analyses finding Avandia carries greater risks than Actos, particularly in older diabetics.

Surprisingly, the study found no difference in heart attack and stroke risks. But since 75 percent of diabetics die from heart-related causes, the researchers think heart attacks and strokes likely contributed to the overall increased deaths in the Avandia group.

“We hypothesize that many of the deaths were due to myocardial infarction (heart attack) and stroke,” Dr. Wolfgang Winkelmayer of Brigham and Women’s Hospital in Boston and colleagues wrote in the Archives of Internal Medicine.

Recent analyses of clinical studies found Avandia raised the risk of heart attacks, which has sent sales of the drug plummeting. An analysis of studies on Actos, meanwhile, suggested it reduced the risk of heart attacks and strokes.

Both Avandia, known generically as rosiglitazone, and Actos, known generically as pioglitazone, raise the risks of heart failure and carry strong warnings on their labels.

“Altogether, the picture people got was it looks like rosiglitazone might be associated with badness and pioglitazone is neutral and even beneficial,” Winkelmayer said in a telephone interview.

“For me, that left an important question open. What if you happen to directly compare those two treatments together.”

He and colleagues studied Medicare claims data from 28,361 U.S. patients older than 65 years who began taking either rosiglitazone or pioglitazone between 2000 and 2005.

ANOTHER PIECE OF THE PUZZLE

They checked for overall risk of death while taking the drug, as well as heart attacks and heart failure and other side effects in this population of older diabetics.

Of those studied, 14,260 began treatment with pioglitazone and 14,101 with rosiglitazone.

“Those who started with rosiglitazone had a 15 percent increased risk of dying from any cause compared with pioglitazone,” Winkelmayer said. They also found patients on rosiglitazone had a 13 percent great risk of heart failure compared with those on pioglitazone.

“The interesting part is that we didn’t find any difference for the risk of stroke or heart attack,” he said.

Winkelmayer thinks this may be because older diabetics are less likely to survive a heart attack or stroke. “This hypothesis we cannot test because we don’t have any cause of death data for these patients. It remains speculation.”

Glaxo disputed the findings. “This new study is inconsistent with evidence from randomized clinical trials and has significant limitations,” said company spokesman Jeff McLaughlin in an e-mail. He said the company’s long-term data suggest no increased risk of death for people taking the drug.

Safety issues raised by the study could be because of differences in the study populations, McLaughlin said, and a randomized clinical trial was the best way to settle safety questions.

Winkelmayer said the study was not a randomized clinical trial, which is the most reliable type of study, but he said the characteristics in both study populations were surprisingly similar, making the comparison quite strong.

“I think it’s one more piece of the puzzle,” he said. “It will contribute to a more compelling picture that will inform policymakers with regard to how to move forward.”

Last month, two major medical groups dropped Avandia from the list of recommended treatments for people with type 2 diabetes, the most common form of the disease.

Some 23.6 million U.S. children and adults have diabetes, according to the American Diabetes Association. Type 2 diabetes is closely linked to obesity.

(Editing by Will Dunham and Cynthia Osterman)

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Reuters reports that a new study shows that the cancer drug Avastin causes an increased risk (by 33%) of blood clots in veins.

The article is reprinted below.

Avastin raises risk of blood clots in veins-study
Tue Nov 18, 2008 4:00pm EST

CHICAGO, Nov 18 (Reuters) – An analysis of 15 clinical trials involving Roche (ROG.VX: Quote, Profile, Research, Stock Buzz) and Genentech’s (DNA.N: Quote, Profile, Research, Stock Buzz) popular cancer drug Avastin raises the risk of developing blood clots in the veins by 33 percent, U.S. researchers said on Tuesday.

The study shows “a significant increased risk with Avastin for patients while they are taking chemotherapy,” said Dr. Shenhong Wu of Stony Brook University Cancer Center in New York, whose study of nearly 8,000 patients appears in the Journal of the American Medical Association. (Reporting by Julie Steenhuysen; Editing by Maggie Fox and Eric Walsh)

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In a welcomed move, the 2nd Circuit Court of Appeals has ruled that a party (American Express) that did not sign an arbitration agreement can not compel consumers to arbitrate their claims against that party.

Hopefully, this will help end the trend of sending consumer claims into arbitration when those claims do not arise from any contractual relationship between the parties. An article detailing the ruling is reprinted below.

2nd Circuit: Plaintiffs in Credit Card Antitrust Case Cannot Be Compelled to Arbitrate

Mark Hamblett
New York Law Journal
November 11, 2008
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Plaintiffs who claim a conspiracy by American Express to cover up an antitrust plot with other major credit card companies on foreign currency transactions won a victory as a federal appeals court said they cannot be compelled to arbitrate.

The 2nd U.S. Circuit Court of Appeals ruled the plaintiffs could not be forced into arbitration because American Express was not a signatory to the MasterCard, Visa and Diners Club credit card agreements that included the arbitration clauses.

The court’s decision came in Ross v. American Express Co., 06-4598-cv, a related case to the multidistrict class action litigation, In Re Currency Conversion Fee Antitrust Litigation, 01-md-01409, now pending before Southern District of New York Judge William Pauley.

In the multidistrict currency conversion case, cardholders are claiming that card companies and major issuing banks have engaged in a Sherman Act conspiracy to fix higher fees for transactions involving foreign currency.

In Ross, the plaintiffs are the same cardholders in the multidistrict litigation, but they are not American Express (Amex) cardholders. The Ross plaintiffs charged in their complaint that American Express plotted with the other major card companies “to fix, maintain, and conceal the artificially inflated” foreign currency fees at issue in the multidistrict litigation. They alleged that American Express was part of the “collusive arrangement between and among the MDL defendants” — in part by holding a series of meetings on including compulsory arbitration agreements “in an effort to impede consumer litigation.”

In the Ross case, Pauley held in 2005 that the plaintiffs could be compelled to arbitrate their claims, but only after a trial to determine the validity of the arbitration clauses.

The judge said “a non-signatory to an arbitration agreement may compel a signatory to that agreement to arbitrate a dispute where careful review … discloses that the issues the non-signatory is seeking to resolve in arbitration are intertwined with the agreement that the estopped party has signed.”

The 2nd Circuit reversed in a decision by Judges Rosemary Pooler and Peter Hall and, sitting by designation, Eastern District of New York Judge David Trager. Pooler wrote for the panel.

“Arbitration is a matter of contract, but the plaintiffs have not entered into any contract whatever with Amex, let alone any contract containing an arbitration clause,” Pooler said.

So the question for the court was whether it would employ any one of a number of common law principles that would allow a nonsignatory to enforce an arbitration agreement, including equitable estoppel. The answer was no.

“The district court’s opinion improperly extends the principle of compelling arbitration through equitable estoppel to a situation where the requisite contractual basis for arbitration does not exist,” Pooler said.

Second Circuit cases applying estoppel against a party trying to avoid arbitration, she noted, have in common that nonsignatories have some kind of “corporate relationship” to a signatory, such as cases involving subsidiaries, affiliates and agents.

And the court has extended that concept beyond affiliated corporate entities to other situations, including where a nonsignatory to a construction contract could compel arbitration because it was explicitly required by the contract to perform certain tasks. That case was Choctaw Generation Ltd. P’ship v. American Home Assurance Co., 271 F. 3d 403 (2d Cir. 2001).

But there are limits, Pooler said, and those limits were exceeded here, because the case “utterly” lacked the “further necessary circumstance of some relation between Amex and the plaintiffs sufficient to demonstrate plaintiffs intended to arbitrate this dispute with Amex.”

Merrill G. Davidoff of Berger & Montague in Philadelphia represented the plaintiffs.

“We think some of the lower courts, including the lower court in this case were misapplying and ‘overapplying’ the doctrine of equitable estoppel to throw cases into arbitration that shouldn’t have been there and we think the court of appeals has appropriately reined in the application of that doctrine,” he said.

American Express spokesperson Joanna Lambert said the company was disappointed in the decision and was reviewing its options. Jonathan Jacobson of Wilson Sonsini Goodrich & Rosati argued for American Express.

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Pain Drugs Double Risk of Second Heart Attack, Death in Study

By Nicole Ostrow

Nov. 11 (Bloomberg) — Heart attack and heart failure patients have a higher risk of a second heart attack or death if they take painkillers including the generic drug ibuprofen and Pfizer Inc.’s Celebrex, a Danish study found.

The risk doubled within the first 90 days on the painkillers Celebrex or Merck & Co.’s withdrawn Vioxx in those who had survived a heart attack or heart failure, compared with those who didn’t take the medications, according to research presented today at the American Heart Association meeting in New Orleans. Other common painkillers, such as the generics diclofenac and ibuprofen, increased the risk between 2.1 and 1.3 times.

About 8.1 million people in the U.S. have had a heart attack and 5.3 million Americans suffer from heart failure, according to the Heart Association Web site. Based on today’s findings, doctors should avoid prescribing painkillers called NSAIDS, or nonsteroidal anti-inflammatory drugs, for these patients, or give them at the lowest dose for the shortest time, researcher Gunnar Gislason said.

“The take-home message is that we need to be careful when using NSAIDs among patients with previous heart attack or heart failure, and we need to carefully consider the balance between risk and benefit when considering starting NSAID treatment in high-risk patients,” said Gislason, a senior resident in cardiology at Copenhagen University Hospital in Denmark, in an e-mail. “Even short-time treatment with NSAIDs seems to increase cardiovascular risk among these patients.”

Painkiller Popularity

The researchers analyzed the records of 58,432 patients who had a previous heart attack and 107,092 with heart failure in Denmark. Of those, 36 percent of the heart attack patients and 34 percent of the heart failure patients said they took at least one painkiller after they were discharged from the hospital.

Patients who had suffered a heart attack and were taking the painkiller Vioxx had 2.7 times the risk of having another heart attack or dying compared with patients not taking painkillers. Heart attack patients taking Celebrex had double the risk, while those with heart failure taking Celebrex had 2.3 times the risk. Heart attack patients taking diclofenac had 1.9 times the risk, while those taking ibuprofen had 1.3 times the risk, according to the study.

Pfizer spokeswoman Shreya Jani said the company couldn’t comment without seeing the study.

“We do know there will be an increased risk of dying from a heart attack in the first year after the event, regardless of NSAID use,” she said. “Since 2005, all prescription NSAIDs, including Celebrex, naproxen, ibuprofen, diclofenac and Mobic amongst others, have boxed warnings that provide important information about possible impact of these medicines on the cardiovascular systems. Patients and doctors should discuss this and other information about medicine and the patient’s health and decide what is right for each patient.”

Celebrex Risks

A study presented in March at the American College of Cardiology meeting in Chicago found that patients taking the highest dose of Celebrex at 400 milligrams twice a day tripled their chance of a heart attack or stroke compared with people taking a placebo. Those taking Celebrex twice daily at the 200- milligram dose doubled their risk of a heart attack. People with heart disease, high cholesterol, diabetes or who smoked also had an increased risk, the researchers said.

A more definitive assessment of Celebrex risks won’t come until 2013, when a $100 million study of 20,000 patients comparing Celebrex with the pain pills ibuprofen and naproxen is expected to be completed. Jani said the safety monitoring committee met recently and noted that the study could continue unchanged.

Celebrex had $2.3 billion in 2007 sales for New York-based Pfizer.

To contact the reporter on this story: Nicole Ostrow in New York at nostrow1@bloomberg.net.
Last Updated: November 11, 2008 10:54 EST

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UPDATE: If you are a Northwestern Mutual Life Insurance Company policyholder who has questions or concerns about class actions in general, feel free to contact us to see if we can help. Call us at 601.366.1297 or submit your question/comment here. IF YOU HAVE QUESTIONS SPECIFIC TO THE NORTHWESTERN MUTUAL SETTLEMENT, PLEASE CLICK HERE.

Northwestern Mutual Life Insurance Company announced that it has settled a class action involving its marketing and sales of term life insurance. An article detailing the announcement is reprinted below.

Northwestern Mutual settles lawsuit

Associated Press
7:06 AM CST, November 13, 2008

MILWAUKEE – Northwestern Mutual Life Insurance Co. has agreed to settle a class action lawsuit for up to $92 million.

The lawsuit accused Northwestern Mutual of failing to pay dividends on certain term life policies and using improper sales and marketing practices.

The lawsuit was filed four years ago by a customer in California who said the insurer’s sales materials misled him about whether dividends would be paid on term life and disability insurance.

Northwestern Mutual denies the lawsuit’s allegations. Company spokeswoman Jean Towell says they decided to settle to avoid “the uncertainty and expense of litigation.”

The proposed settlement covers about 1.3 million current and 1.6 million former policy owners who purchased term life or disability coverage since 1981.

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