Sunday, November 19, 2006

Chicago Tribune: Screening for Lung Cancer

Article in the Chicago Tribune -- LUNG CANCER, To screen or not to screen: A case for early detection, by Hasham A. Hassaballa:

"Is there no way to screen for lung cancer like other cancers?"

That question ignites one of the most contentious debates in modern pulmonary medicine, and the results of a study published last month in the New England Journal of Medicine have only added to the controversy.

Researchers from more than 30 hospitals around the world, led by Weill Cornell Medical College, used CT scans to screen about 31,000 people who were at a high risk for lung cancer.

They found cancer in 484 of those participants, 412 of whom had Stage 1 disease, the earliest stage. Most had surgery, although some were treated with chemotherapy and radiation as an alternative to surgery. Eight patients received no treatment.

The researchers estimated that 88 percent of patients with Stage 1 lung cancer would survive 10 years. And if patients begin treatment within one month of their diagnosis, it is estimated that 92 percent of them would be alive 10 years later. The eight patients who received no treatment all died within five years.


November 19, 2006 in Tobacco | Permalink | Comments (1) | TrackBack (0)

Chicago Tribune: Risky Hemophilia Drug Used on U.S. Troops

Article in the Chicago Tribune -- Risky drug used on wounded troops, by the Associated Press: " A blood-coagulating drug designed to treat rare forms of hemophilia is being used on critically wounded U.S. troops in Iraq despite evidence it can cause clots that lead to strokes, heart attacks and death in other patients, The Baltimore Sun reported Sunday."


November 19, 2006 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

Washington Post: Using Nicotine Patch Before Quitting Smoking Ups Success

Article in the Washington Post -- Using Nicotine Patch Before Quit Date Ups Success, by Kathleen Doheny:

Giving nicotine patches a two-week "head start" more than doubles the chances they'll help smokers kick the habit, research finds.

A U.S. team found that by applying the patch 14 daysbeforethat last cigarette, users greatly boosted their long-term success rate.

The initial study was published earlier this year in the journalNicotine and Tobacco Research, and a second trial has now replicated those findings, according to Jed E. Rose, medical research professor and director of Duke University's Center for Nicotine Cessation Research. He led the original study and is co-inventor of the nicotine patch.


November 19, 2006 in Tobacco | Permalink | Comments (0) | TrackBack (0)

Attorney's Fees and the Swiss Bank Holocaust Litigation

The Los Angeles Times today ran two opinion pieces regarding the attorney fee petition in the Swiss Bank Holocaust litigation of Professor Bert Neuborne of New York University School of Law.  Here is an excerpt from Profiting from the Holocaust, by Menachem Z. Rosensaft, a lawyer in New York who is the founding chairman of the International Network of Children of Jewish Holocaust Survivors:

IF LAWYERS EVER WONDER, in a rare moment of introspection, why they are generally held in low esteem, they need look no further than the obscene fee application pending before a federal magistrate judge in Brooklyn, N.Y.

Burt Neuborne, the court-appointed lead settlement counsel in a class action brought on behalf of Holocaust survivors against Swiss banks, has turned himself into the poster boy for avaricious attorneys. He demands $4.75 million for his role in administering the $1.25-billion settlement and determining distribution of the money. . . .

Neuborne wants to be paid $700 an hour for the roughly 6,800 hours he claims to have spent on the Swiss banks case between Feb. 1, 1999, and Oct. 1, 2005. (Earlier this year, he agreed to remove 1,500 hours from his fee application after some of his billing practices were challenged.) That averages out to about 20 hours a week, for which he wants to be paid, again on average, $675,000 a year. This would be on top of $4.4 million he received in 2001 from another Holocaust-era settlement with German corporations that had exploited Jews and Roma/Sinti as slave laborers during World War II.

Responding to such criticism, Professor Neuborne wrote What profit? I gave up $10 million.  Here's an excerpt:

ATTACKS ON ME for seeking a court-awarded fee for seven years of labor as the lead lawyer in the $1.25-billion Swiss banks Holocaust settlement give new meaning to the phrase "no good deed goes unpunished."

I began my work on behalf of Holocaust survivors in December 1996, when U.S. District Judge Edward R. Korman asked me to serve as counsel in the Swiss banks litigation. I redrafted the complaints, wrote the principal legal brief, argued the case and spearheaded the negotiations that succeeded on Aug. 12, 1998, in obtaining the historic settlement. I then told Korman that although I was entitled to as much as $10 million, I would not seek a fee for those services. At that point, no one expected me to do more work on the Swiss banks case. Instead, beginning in September 1998, I devoted myself to the German slave labor cases that led to the creation of the $5.2-billion German Holocaust Foundation.

In April 1999, Korman asked me to return to the Swiss banks case to carry out the complex settlement. Given the grueling, time-consuming nature of the work, he agreed that I would be entitled to reasonable hourly fees. Korman has publicly acknowledged that he "retained me" and that I am entitled to a fee. My detractors say Korman should have given formal notice that I was no longer working for free. But notice to a class of 1 million people would have cost a fortune (it cost $40 million to give notice of the terms of the settlement) while accomplishing nothing because the class was not entitled to insist that I return to work for them for free.

My work as lead settlement counsel over the last seven years has been massive and unrelenting, requiring me to spend, to date, more than 7,000 hours providing complex legal services to the settlement fund. I appeared in 30 contested legal proceedings, including multiple federal appeals, two Supreme Court proceedings and three trial-type hearings in the district courts.


November 19, 2006 in Class Actions, Ethics, Settlement | Permalink | Comments (1) | TrackBack (0)

LA Times: Cancer from U.S. Uranium Mines on Navajo Reservation

Article in today's Los Angeles Times -- A peril that dwelt among the Navajos, by Judy Pasternak.  The article is the first part of a multi-part series.  Here's an excerpt:

Fifty years ago, cancer rates on the reservation were so low that a medical journal published an article titled "Cancer immunity in the Navajo."

Back then, the contamination of the tribal homeland was just beginning. Mining companies were digging into one of the world's richest uranium deposits, in a reservation spanning parts of Arizona, New Mexico and Utah.

From 1944 to 1986, 3.9 million tons of uranium ore were chiseled and blasted from the mountains and plains. The mines provided uranium for the Manhattan Project, the top-secret effort to develop an atomic bomb, and for the weapons stockpile built up during the arms race with the Soviet Union.

Private companies operated the mines, but the U.S. government was the sole customer. The boom lasted through the early '60s. As the Cold War threat gradually diminished over the next two decades, more than 1,000 mines and four processing mills on tribal land shut down.

The companies often left behind radioactive waste piles and open tunnels and pits. Few bothered to fence the properties or post warning signs. Federal inspectors seldom intervened.

Over the decades, Navajos inhaled radioactive dust from the waste piles, borne aloft by fierce desert winds.

They drank contaminated water from abandoned pit mines that filled with rain. They watered their herds there, then butchered the animals and ate the meat.

Their children dug caves in piles of mill tailings and played in the spent mines.

And like the Holidays, many lived in homes silently pulsing with radiation.

Today, there is no talk of cancer immunity in the Navajos.


November 19, 2006 | Permalink | Comments (0) | TrackBack (0)

Saturday, November 18, 2006

LA Times: Second Circuit to review 'light' cigarette class certification

Article in the Los Angeles Times -- Appeals court to review 'light' cigarette ruling, by Reuters: "A U.S. appeals court has decided to review a lower court ruling that let a $200-billion lawsuit filed by "light" cigarette smokers proceed as a class action and stopped proceedings in the suit."


November 18, 2006 in Class Actions, Tobacco | Permalink | Comments (0) | TrackBack (0)

Friday, November 17, 2006

WSJ: Naproxen Tied To Heightened Risk Of Heart Attacks

Article in the Wall Street Journal -- Naproxen Is Tied To Heightened Risk Of Heart Attacks, by Peter Loftus:

A disputed government study of common painkillers found that naproxen increased the risk of heart attack and other cardiovascular events compared with a fake pill, according to data published yesterday, nearly two years after the study was halted.

The study's results relate to whether naproxen, which is sold over the counter as Aleve by Bayer AG of Germany, is as safe as is commonly believed. The results didn't point to a clear conclusion. The class of drugs to which naproxen belongs is generally considered to carry some heightened cardiovascular risks. This study's results "provide some support" for that theory, the study's authors wrote, but added that "the measure of this risk remains a matter of speculation."

Bayer said in a statement the "overwhelming body of scientific evidence" supports naproxen's safety. The company also noted the study involved long-term use of naproxen to ward off Alzheimer's disease, which isn't consistent with Aleve's intended use as a short-term pain reliever.


November 17, 2006 in Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (3)

They're Back . . . Silicone Breast Implants Win FDA Backing

Article in the Wall Street Journal -- Breast Implants Made of Silicone Win FDA Backing, by Rhonda L. Rundle and Anna Wilde Matthews:

Nearly 15 years after banning silicone breast implants in most cases, the Food and Drug Administration approved revamped versions at a time of soaring demand for cosmetic procedures.

Many of the original marketers, who lost billions of dollars in lawsuits related to allegedly flawed silicone implants, are long out of the business. Still, the FDA's approval late Friday will accelerate a push into aesthetic medicine by two companies that are heirs to the U.S. breast-implant business: Allergan Inc. and Mentor Corp.

Both companies are betting big on the burgeoning cosmetic-medicine market. They expect the new implants -- approved for cosmetic augmentation in women age 22 and older, and for reconstructive use in women of all ages -- to draw a generation of body-conscious buyers too young to remember the high-profile health concerns that silicone implants once sparked.

Here are links to related New York Times articles:  F.D.A. Will Allow Breast Implants Made of Silicone, by Stephanie Saul; Silicone Implants to Overtake Saline, by the Associated Press; and U.S. Ends Ban on Silicone Breast Implants, by the Associated Press.   Mentor has already set up a website to the sell the silicone breast implants:

Here's a link to the 1999 Institute of Medicine Report that did not find a link between silicone breast implants and the illnesses previously alleged in the silicone breast implant litigation of the early 1990s.


November 17, 2006 in FDA | Permalink | Comments (0) | TrackBack (1)

Thursday, November 16, 2006

WSJ on the Merck Vioxx Win Yesterday

Article in the Wall Street Journal -- Merck Adds Another Win In Vioxx Trials, by Avery Johnson and Heather Won Tesoriero:

In a case that adds momentum to Merck & Co.'s Vioxx defense strategy, the drug maker prevailed in the 11th trial over the painkiller after a New Orleans jury cleared the company of responsibility in a man's heart attack.

Merck's win, which came after the jury deliberated just 90 minutes, gives the company a slight edge on the trial scorecard with six victories and four losses. (Another Merck victory was tossed out and will be retried in January.) It still faces some 24,000 lawsuits, however, and the pendulum could swing back in the plaintiffs' direction. Both sides are eager to notch as many early victories as possible before judges overseeing the litigation start corralling them into a settlement.

Merck's strategy of fighting each lawsuit one by one, and its recent winning streak in the courtroom, have helped to restore confidence in the prospects of the Whitehouse Station, N.J., company. After being preoccupied with Merck's Vioxx liability for much of the past two years, investors lately have become much less worried about the litigation.


November 16, 2006 in Vioxx | Permalink | Comments (1) | TrackBack (0)

WSJ: Data From Tamiflu Maker Point to Flu as Source of Psychiatric Problems

Article in the Wall Street Journal -- Data From Tamiflu Maker Point to Flu as Culprit, by Patricia Kowsmann:

The U.S. Food and Drug Administration said Thursday that it received new data from Tamiflu manufacturer Roche Holding AG suggesting that psychiatric problems seen in some patients taking the drug are a result of the flu and not the drug itself.

The agency said it received the new data last week and are still conducting a review. The announcement was made during a FDA panel meeting to discuss the safety review of 16 drugs, including the flu drug, in pediatric patients.

On Tuesday, Tamiflu's label was updated to warn patients of potential abnormal behavior during treatment, including delirium and hallucinations. The change followed a 10-month review by the FDA that found 103 cases of "neuropsychiatric adverse events" in people who were taking the drug. The events included the death of a 14-year-old boy who fell after climbing on his condominium balcony railing.


November 16, 2006 in FDA | Permalink | Comments (0) | TrackBack (6)

Washington Post: Atlantic City Smoking Ban Moves Forward

Article in the Washington Post -- Atlantic City Smoking Ban Moves Forward, by the Associated Press:

Casinos that helped push through an exemption to a new statewide smoking ban may have to start clearing the air anyway.

The City Council voted unanimously Wednesday to introduce a proposal to eliminate smoking in all public places, including gambling floors at the city's 13 casinos.

A final vote could take place late next month, and the measure could take effect as soon as January if approved and signed by the mayor.


November 16, 2006 in Tobacco | Permalink | Comments (0) | TrackBack (2)

Washington Post: Philip Morris Asks to Cut Cigarette Use in Movies

Article in the Washington Post -- Philip Morris Asks to Cut Cigarette Use in Movies, by Larry O'Dell:

The nation's largest cigarette maker is asking Hollywood not to put its products on the big screen, citing studies that have shown cinematic portrayals of tobacco use can entice children to smoke.

Richmond-based Philip Morris USA said Wednesday that it will run advertisements in Daily Variety, the Hollywood Reporter and other trade publications imploring moviemakers: "Please Don't Give Our Cigarette Brands a Part in Your Movie."

The ad campaign begins this week and will last several months, Philip Morris spokesman David Sutton said. He said the initiative was conceived after meetings with entertainment industry representatives.


November 16, 2006 in Tobacco | Permalink | Comments (0) | TrackBack (0)

NYT: Heart Risk for Anemia Drug Epoetin

Thanks to Amalia Goldvaser for sending me the following article in the New York Times -- Heart Risk Seen in Drug for Anemia, by Alex Berenson:

A medical study to be released today suggests that high doses of a best-selling drug used to treat anemia in dialysis and cancer patients may increase the risk of heart problems and deaths.

Almost a million Americans a year receive prescriptions for the drug, known as epoetin, or darbepoetin, a closely related drug also used in anemia treatment. Worldwide, sales of the two drugs — sold under the brand names Epogen, Procrit and Aranesp — topped $9 billion last year for Amgen and Johnson & Johnson, their makers.

Researchers for the study, to be published in The New England Journal of Medicine, divided anemic patients with kidney disease into two groups. One group received epoetin with a goal of almost fully correcting their anemia, a lack of red blood cells associated with fatigue and shortness of breath.


November 16, 2006 in FDA | Permalink | Comments (0) | TrackBack (3)

Wednesday, November 15, 2006

Chicago Tribune: Child Heart Defect Linked with Smoking by Mother & Secondhand Smoke

Article in the Chicago Tribune -- Mom smoking, heart defect linked, by Ronald Kotulak:

Smoking cigarettes just before becoming pregnant and shortly thereafter may increase a woman's risk of having a baby with a congenital heart defect by 60 to 80 percent, according to a report presented Tuesday at a meeting of the American Heart Association in McCormick Place.

And women who are exposed to second-hand smoke in the workplace or at home may also increase their risk of bearing infants with such defects, said Dr. Sadia Malik, a pediatric cardiologist at the University of Arkansas for Medical Sciences, the study's lead author.

"We found a 30 percent higher risk of having a child with congenital heart disease if you're exposed to cigarette smoke at home or the workplace," she said.


November 15, 2006 in Tobacco | Permalink | Comments (0) | TrackBack (5)

Another Vioxx Verdict for Merck

Merck won a defense verdict today in the latest Vioxx trial.  Plaintiff Charles Laron "Ron" Mason had taken Vioxx for ten months, and alleged that it caused his heart attack.  During trial, Mason realized during cross-examination that he had stopped taking Vioxx several days before the heart attack, which apparently came as a surprise both to Mason and to his lawyer.  In closing arguments, Merck contended that Vioxx cannot cause a heart attack if it is out of the system, which occurs within a few days.  The case was tried in E.D. La. before Judge Eldon Fallon, who is overseeing the federal multidistrict litigation.  Here's an article in the Washington Post by Janet McConnaughey (AP), Jury Clears Merck in Latest Vioxx Trial, and one from Russell McCully (Reuters), Merck wins federal Vioxx case in New Orleans.  Despite a few major losses, Merck has won a majority of the Vioxx cases that have gone to trial, and each defense verdict strengthens Merck's position in the litigation and supports Merck's strategy of trying each case individually, avoiding both aggregation and settlement.


November 15, 2006 in Vioxx | Permalink | Comments (0) | TrackBack (0)

NYT: FDA Panel on Sanofi-Aventis Drug Ketek

Article in the New York Times -- F.D.A. to Seek Advice of Expert Panel on Safety of Sanofi-Aventis Drug, by Reuters:

Food and Drug Administration officials said Tuesday they planned to ask outside advisers next month if the antibiotic Ketek made by Sanofi-Aventis should stay on the market after reports of liver failure in a dozen patients.

The antibiotic which was approved in 2004 is also the subject of a Senate Finance Committee investigation of the F.D.A.’s handling of the approval and of possibly faulty data.

“We will ask the committee if the overall risk/benefit profile supports continued marketing of Ketek for various indications,” an F.D.A. spokeswoman, Laura Alvey, said.

Here's a link to the Wall Street Journal article, Review of Sanofi Drug is Sought, by the Associated Press.


November 15, 2006 in FDA | Permalink | Comments (2) | TrackBack (0)

Tuesday, November 14, 2006

Washington Post: CT Scans For Smokers?

Article in the Washington Post -- For Smokers, a Tough Call: Despite New Study, Experts Are Split on Whether the Benefits Of Early CT Screening for Lung Cancer Outweigh the Potential Risks, by Sandra Boodman:

To screen or not to screen?

That is the question patients -- most of them current or former smokers -- are asking doctors following the publication of a large international study that found that spiral CT scans can detect lung cancer at its earliest and most curable stage.

The results, published last month in the New England Journal of Medicine, have fueled hope that the technology can lead to early treatment of the most common cause of cancer death, as mammography has done for breast cancer.

But the study involving more than 31,000 current and former smokers headed by researchers at Weill Medical College at Cornell University failed to answer a fundamental question: Does screening extend lives or merely find cancer earlier? Because the study did not use a control group, there is no way to tell whether the risks of screening, which include repeated radiation exposure and the possibility of aggressive follow-up treatment, outweigh the benefits of early detection, experts from the American Cancer Society and other groups say.


November 14, 2006 in Tobacco | Permalink | Comments (0) | TrackBack (0)

WSJ: FDA Warns Bausch & Lomb

Article in the Wall Street Journal -- FDA Warns Bausch & Lomb On Lens-Solution Infections, by Patricia Kowsmann:

Bausch & Lomb Inc. received a warning letter from the Food and Drug Administration, following an inspection of the company's Greenville, S.C., plant from March 22 through May 15. The inspection was in connection with reports that some users of Bausch & Lomb's ReNu with MoistureLoc contact-lens solution contracted a rare eye infection.

The Rochester, N.Y., company pulled the cleaning solution from world-wide markets in May after it said the product's formulation combined with certain use patterns likely contributes to an increased risk of Fusarium keratitis, a fungal eye infection that can lead to blindness.

The warning letter, dated Oct. 31 and addressed to company Chairman and Chief Executive Ronald L. Zarrella, reiterated preliminary findings the FDA reported in May. Like the preliminary report, the letter said the inspection didn't identify any conditions that contributed to or caused the infection, but it did find other problems.


November 14, 2006 in FDA | Permalink | Comments (0) | TrackBack (1)

WSJ on Merck Chief

Article in the Wall Street Journal -- Merck's Chief Leads a Revival,But Will It Last?, by John Carreyrou:

In a bid to restore the public's faith in Merck, which has been battered by allegations that the company knew Vioxx had serious cardiovascular side effects long before it withdrew it, the media-shy executive endured numerous takes during the filming of a TV commercial with the slogan "Putting Patients First."

Mr. Clark, 60 years old, has also raised morale among employees who have suffered from the company's Vioxx-related vilification. Shedding the aloof manner of many CEOs, he mingles with employees in the company cafeteria and holds meetings with groups of randomly selected employees once a month. During the meetings, Mr. Clark shares with employees a score card he keeps to chart progress toward the goals he has set, and encourages them to speak their minds. "The Merck culture had become too polite," he says.


Moreoever, a big reason for the rebound in Merck's stock is that investors have gone from obsessing about the company's Vioxx liability to largely discounting it. That is because Merck's strategy of fighting each case one by one has yielded some victories (Merck has won five cases and lost four) and dragged out the litigation process. The company has spent $610 million in legal fees. But Merck adopted that strategy before Mr. Clark's appointment. Mr. Clark says he has put "a fence around Vioxx mentally" and gets updates on the litigation from Ken Frazier, Merck's general counsel, only once a week.


November 14, 2006 in Vioxx | Permalink | Comments (0) | TrackBack (0)

WSJ: FDA Urges Caution on Tamiflu

Article in the Wall Street Journal -- FDA Urges Caution on Flu Drug, by Patricia Kowsmann:

Food and Drug Administration staff recommended that the label for Roche Holding AG's flu drug Tamiflu be updated to include a precaution related to possible psychiatric problems in patients who take it.

The move follows a 10-month review that found 103 cases of "neuropsychiatric adverse events," including the death of a 14-year-old boy who fell after climbing on a balcony railing.

Here's a link to the New York Times article, Monitor Children on Flu Drug, F.D.A. Urges, by the Associated Press; to the Washington Post article, Flu Drug Label Will Warn of Risks, FDA Says, by Andrew Bridges; and to the Los Angeles Times article, Tamiflu linked to abnormal behavior, by Jia-Rui Chong.


November 14, 2006 in FDA | Permalink | Comments (0) | TrackBack (0)