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 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.
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: Mentor4me.com.
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 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.
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.
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.
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.
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 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.
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.
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 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.
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.
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.
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.
WSJ: Sanofi-Aventis Antibiotic Under FDA Scrutiny
Article in the Wall Street Journal -- Sanofi-Aventis Antibiotic Faces New FDA Scrutiny, by the Associated Press:
An antibiotic from Sanofi-Aventis SA that has been linked to rare reports of severe liver problems -- including several deaths -- will be subjected to new scrutiny by federal health advisers, according to a document released Tuesday.
The Food and Drug Administration has asked a joint panel of outside experts to discuss the overall risks and benefits of the French drug maker's Ketek antibiotic during a Dec. 14-15 meeting, according to a federal notice.
The announcement comes as the Senate Finance Committee investigates allegations of fraud connected with trials of Ketek, as well as how the FDA has handled safety issues associated with the drug. The joint panel's two-day review of Ketek could lead to a recommendation that the agency add further warnings to the drug's label or take other action.
Here's a link to the New York Times article, FDA Subjects Antibiotic to New Scrutiny, by the Associated Press.
November 13, 2006
Vioxx Class Action Certified in Canada
A judge in Canada has authorized a class action of Vioxx personal injury claims, according to this Nov. 11 story in The Globe and Mail -- Vioxx Class Action Allowed:
Merck & Co. Inc. suffered a setback in its Vioxx defence strategy as a Quebec court denied a company request to hear individual lawsuits from patients and instead granted plaintiffs class-action status.
Mr. Justice André Denis of the Quebec Superior Court said the decision would avoid thousands of separate legal actions. He narrowed the scope of the first personal injury class-action lawsuit in the mushrooming litigation against Vioxx to about 4,000 former users between 1999 and 2004, excluding those who took the medicine and didn't claim injuries from taking it.
The class representatives are Gerald Sigouin and Roger Ste-Marie, both of whom allege that they suffered cardiac problems after taking Vioxx.
The class certification decision contrasts with the treatment of the litigation in the United States, where no Vioxx personal injury class action has been certified. Individual rather than aggregate treatment of the litigation has been a cornerstone of Merck's strategy in the Vioxx litigation. The only Vioxx class action that has been certified in the U.S., as far as I know, is an action for economic damages by third-party payors in New Jersey Superior Court.
Merck Drops Fee Objections
Merck has abandoned some of its objections to a fee request by plaintiffs in order to avoid disclosing its own legal fees in a Vioxx trial. As we discussed here on October 18, prevailing plaintiffs are entitled to seek fees under the New Jersey Consumer Fraud Act. When Merck objected to the size of plaintiffs' $5.6 million fee request in the Cona and McDarby case, plaintiffs demanded to know how much Merck had spent on the same trial. Judge Higbee ordered Merck to disclose the information, at which point Merck reported that it would explore its options. Apparently the option of disclosing its own defense legal fees was less appealing than the option of paying plaintiffs' fees. Here's a clip from a Nov. 10 Boston Globe article by Theresa Agovino (AP) -- Merck drops some objections to request:
Merck & Co. agreed to drop some of its objections to plaintiff lawyers' request for fees in a Vioxx case, but only if it doesn't have to disclose its own legal fees to a judge.
Plaintiff lawyer Ellen Relkin said Merck dropped some of its objections because it fears a N.J. judge may publicly disclose what it spent on a trial that ended earlier this year. Merck lawyer Ted Mayer said the drugmaker's legal fees have no relation to the plaintiff lawyers' request and that companies always want to be careful when asked to reveal such sensitive information.
November 12, 2006
Council delays vote on smoking ban
Article in the Chicago Tribune -- Council delays vote on smoking ban, by Jennifer Taylor: "The Naperville City Council tabled debate this week on a proposed smoking ban, opting instead to hear more public testimony before deliberating on the matter."
FDA May Change Handling of Safety Issues
Article in the Washington Post -- FDA May Change Handling of Safety Issues, by the Associated Press:
The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.
As it does so, it plans to utilize data-mining techniques that could give the agency early warning of potential problems.
The FDA effort, being announced Thursday, parallels similar efforts under way to improve the agency's response to drug safety concerns.