Drug Safety Developments

Pfizer Settles Prempro Case on Breast Cancer Before Retrial on Damages

Quoted from http://www.bloomberg.com/news/2010-08-27/pfizer-settles-arkansas-prempro-case-before-retrial-over-punitive-damages.html

Pfizer Settles Prempro Case on Breast Cancer Before Retrial on Damages

By Jef Feeley - Aug 27, 2010 6:27 PM ET

Pfizer Inc. agreed to settle an Arkansas woman’s claims that the company’s Prempro menopause drug caused her breast cancer, avoiding a second punitive damages trial in the case, according to a court filing.

New York-based Pfizer faced an Oct. 1 retrial of Donna Scroggin’s claims that the world’s largest drugmaker should pay millions of dollars as punishment for mishandling its Prempro hormone-replacement medicine, according to court records. An appeals court overturned a $27.1 million punitive award last year and ordered a new trial on damages.

The company agreed to settle Scroggin’s case, U.S. District Judge William Wilson said in an Aug. 19 court filing. Wilson is overseeing more than 8,000 cases involving the medicine, consolidated in federal court in Arkansas. Terms of the settlement weren’t disclosed in the filing.

“It makes sense for Pfizer to settle because of the potential for exposure if the punitive-damages issue goes back before another jury,” Carl Tobias, a University of Richmond Law School professor who teaches classes on mass-tort law, said in an interview.

Pfizer officials declined to comment on Scroggin’s settlement, Victoria Davis, a company spokeswoman, said in an e- mail last week. Jim Morris, one of Scroggin’s lawyers, also declined to comment.

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US FDA releases latest list of safety issues

Quoted from http://www.reuters.com/article/idUSN2726540720100827

US FDA releases latest list of safety issues

Fri Aug 27, 2010 2:26pm EDT

WASHINGTON Aug 27 (Reuters) - The U.S. Food and Drug Administration has released its latest list of possible drug safety concerns, citing Roche's (ROG.VX) breast cancer drug Herceptin and Sanofi Aventis' (SASY.PA) heart drug Multaq, among others.

The list, which comes out quarterly, covers safety issues that the FDA flagged between April and June and was released on the agency's website on Friday.

Other drugs listed include Merck & Co Inc's (MRK.N) birth control Implanon, Pfizer's (PFE.N) antibiotic Cleocin and Novartis' (NOVN.VX) Afinitor.

Takeda Pharmaceutical's (4502.T) gout management drug Uloric, AMAG Pharmaceutical's (AMAG.O) anemia drug Feraheme and Shire Plc's (SHP.L) phosphate binder Fosrenol were also included, among others.

In most cases, the FDA offered few clues into what the concerns were and simply said the agency "is continuing to evaluate this issue to determine the need for any regulatory action."

Merck's cholesterol drug Zocor, Genentech's HIV drug Invirase and various GnRH agonists were also listed, but the agency has already issued more specific safety alerts on those drugs. Genentech is a unit of Roche.

Johnson & Johnson's (JNJ.N) Nucynta, a pain treatment, was also listed as having a risk of convulsions, hallucinations and serotonin syndrome.

FDA also named omeprazole products, used to treat ulcers, saying there is a risk the drug could cause low levels of magnesium in the blood.

The drug manufacturers were not immediately available for comment.

The list is online at: link.reuters.com/myg77n (Reporting by Susan Heavey; Editing by John Wallace and Richard Chang)

Takeda's Actos Has Same Heart Risks as Glaxo's Avandia, Researchers Find

Quoted from http://www.bloomberg.com/news/2010-08-24/diabetes-drug-actos-has-same-heart-risks-as-glaxo-s-avandia-study-finds.html

Takeda's Actos Has Same Heart Risks as Glaxo's Avandia, Researchers Find

By Kanoko Matsuyama - Aug 25, 2010 2:33 AM ET

Takeda Pharmaceuticals Actos diabetes pills. Photographer: JB Reed/ Bloomberg

Takeda Pharmaceutical Co.’s diabetes drug Actos causes as many heart problems as Avandia, the GlaxoSmithKline Plc pill that had a decline in sales after being linked to higher heart-disease rates, a study found.

Patients taking Avandia or Actos were 4 percent more likely to experience heart attacks, heart failure or die, according to the study published yesterday in the American Heart Association journal, Circulation.

Actos become the market leader after a 2007 study showed a 43 percent higher chance of heart attacks from Avandia, which generated $3.3 billion of sales before the findings. The latest study, the first to compare the drugs, suggests the risks are tied to that category of medicine, said Jenny Gunton, a diabetes researcher at the Garvan Institute of Medical Research.

“It just maybe increases the worry of using either of the drugs,” Gunton, who wasn’t involved in the study, said in a telephone interview from Sydney. A rate of 4 percent is “pretty high” given the short study period, she said.

U.S. regulators are reviewing whether Avandia, which is classed as the same type of treatment as Actos, should be taken off the market after a panel advised on July 14 that warnings about its risks should be added to prescription information.

The study involved more than 36,000 diabetes patients with an average age of 54 years and took place over 33 months, including 14 months of treatment on either medication.

Among the patients, 602 who took Avandia and 599 Actos users suffered either a heart attack, heart failure, or both, or died, the study showed. There were 217 deaths in each group.

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With Birth Control Pills, New Isn't Always Better

Quoted from http://www.npr.org/templates/story/story.php?storyId=129258505

With Birth Control Pills, New Isn't Always Better

by Richard Knox

August 23, 2010

Listen to the Story

Birth control pills are often marketed as doing much more than prevent pregnancy. The drugs also claim to treat acne, moodiness and bloating. But some researchers caution that these benefits do not outweigh the health risks known to accompany taking the pill.

Birth control pills are often marketed as doing much more than prevent pregnancy. The drugs also claim to treat acne, moodiness and bloating. But some researchers caution that these benefits do not outweigh the health risks known to accompany taking the pill.

Bayer HealthCare, the leading maker of birth control pills, is coming out with a brand new pill.

Natazia, as it's called, contains a form of estrogen that's never been used in an oral contraceptive. It also has a novel dosing regimen. Women on Natazia will take four different combinations and doses of hormones or sugar pills each month.

The new launch coincides with growing problems for Bayer's last new contraceptive, Yaz.

Beyond Birth Control

After Yaz came out in 2006, it quickly became America's No. 1 birth control pill, bringing Bayer $800 million last year. But now thousands of women are suing Bayer because they say Yaz caused them serious harm. Sales have dropped 15 percent in the past year.

It's a good time to look at the Yaz saga and see if it has anything to teach women and their doctors when they choose a contraceptive.

Yaz was something entirely new in the long history of birth control pills — and not just in its chemical formulation. It was the first pill to be marketed for multiple purposes. Bayer promoted it heavily as going "beyond birth control."

A centerpiece TV ad noted that "all birth control pills are 99 percent effective and can give you shorter, lighter periods. But there's one pill that goes beyond the rest. It's Yaz."

On the screen, brightly colored balloons floated upward. Each balloon had a label — moodiness, irritability, feeling anxious, increased appetite, bloating, fatigue, headaches, muscle aches, acne. In the background, The Veronicas sang "Goodbye to You."

Enlarge Jane Greenhalgh/NPR

Katie Anderson, shown with her mother, Beth, suffered a life-threatening pulmonary embolism. Her symptoms started within a month of taking the birth control pill Yaz.

A Cautionary Tale

Those ads caught the attention of a 16-year-old in Maryland named Katie Anderson.

"I do remember going to the gynecologist and asking for Yaz because I had seen the commercials," says Anderson, who's now 19. "That was the one I wanted."

Anderson hoped Yaz would even out her irregular periods. She liked the implication that Yaz could treat premenstrual syndrome. And, of course, the idea of clear skin appealed to her, too.

"What girl would not fall for something that says, you know, it's going to help with moderate or mild acne?" she says. "That's great! That's just a perk, that's a plus."

So she got her doctor to write a prescription for Yaz. It's a choice she'd live to regret.

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Glaxo’s Summary of a Hearing on Avandia Is Challenged

Quoted from http://www.nytimes.com/2010/08/20/health/policy/20fda.html

Glaxo Memo on Avandia Is Questioned

By GARDINER HARRIS

Published: August 19, 2010

Federal drug regulators ordered GlaxoSmithKline to send a letter to crucial doctors describing a hearing in July where an expert advisory panel discussed the risks of Avandia, the company’s controversial diabetes medicine.

Dr. David Graham, of the Food and Drug Administration, called Glaxo's summary “biased, misleading and not truthful.” ...

Doctors who received the letter, dated July 28, are investigators in a study called the Tide trial, which was intended to compare the heart risks of Avandia with those of Actos, a similar drug made by Takeda Pharmaceuticals.

Results of the trial, which was requested by the F.D.A., are not expected for years. The ethics of the Tide trial were a point of contention at the advisory committee hearing, and the F.D.A. ordered GlaxoSmithKline to stop recruiting new patients into the trial, although current patients could continue.

Dr. David Graham, an F.D.A. medical officer, made an impassioned presentation at the advisory hearing arguing that the study should be stopped because thousands of patients in the trial were being exploited. None of these arguments were mentioned in GlaxoSmithKline’s letter.

 

“This summary is biased, misleading and not truthful,” Dr. Graham said in an interview. “The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced.”

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Philadelphia jury clears Prempro in two breast-cancer cases

Quoted from http://www.philly.com/inquirer/breaking/business_breaking/20100818_Philadelphia_jury_clears_Prempro_in_two_breast-cancer_cases.html

Philadelphia jury clears Prempro in two breast-cancer cases

By Linda Loyd

INQUIRER STAFF WRITER

A Philadelphia Common Pleas Court jury said Wednesday that two women's breast cancers were not linked to Wyeth's menopause drug, Prempro.

After less than four hours of deliberation, the jury rejected claims by Sharon Buxley, 66, a Tennessee resident formerly of Allentown, and Joy Henry, 75, of Harrisburg, that the hormone-replacement therapy helped cause their cancers.

The jury found that Prempro was "not a factual cause" in the development of the breast cancer.

 

The plaintiffs argued during the four-week trial before Common Pleas Court Judge James Murray Lynn that Pfizer Inc.'s Wyeth subsidiary knew the treatment could promote the growth of cancer and should be held legally liable.

Pfizer attorney Beth Wilkinson spoke to jurors afterward. "They clearly understood the science. They had a very good grasp of the issues." She said medical experts who are practicing physicians told the jury "they didn't believe there was evidence that Prempro caused breast cancer in these women."

In 2002, a National Institutes of Health-sponsored study concluded the menopause drug posed an increased cancer risk. Millions of women have taken hormone-replacement drugs.

Plaintiffs attorney Zoe Littlepage vehemently disagrees with Wyeth's claims of success in the long-swirling litigation.

"There have been 15 trials; plaintiffs won 11 of them," she said. "Fifteen juries have deliberated, and 11 of those juries have said the women win. In almost all the verdicts, the judge reduced the putative damage amounts because the numbers have been so high."

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FDA questions wider approval of Lilly's Cymbalta

Quoted from http://www.google.com/hostednews/ap/article/ALeqM5imhQxoC38eZsccOCB3oRHh0vjfzgD9HLBLSO0

FDA questions wider approval of Lilly's Cymbalta

By MATTHEW PERRONE (AP) – August 17, 2010

WASHINGTON — Federal health scientists are questioning whether the antidepressant Cymbalta is safe and effective enough to be approved for use against chronic pain.

The Food and Drug Administration on Tuesday posted its review of Eli Lilly and Co.'s application to market the drug for a range of pain ailments, including lower back pain. But FDA reviewers appeared cautious about further expanding use of a powerful psychiatric drug already used by nearly 15 million patients.

FDA reviewers raised questions about the statistical methods used to study the drug and its liver side effects.

The drug is already approved to treat depression, diabetic nerve pain and fibromyalgia.

The FDA will ask a panel of outside experts on Thursday to consider whether Cymbalta should be approved for chronic pain.

Eli Lilly has been trying to gain approval for the new indication for more than two years. The company withdrew its FDA application in November 2008 after agency evaluators questioned the method and design of some of the company's trials. The company resubmitted its application last summer with new data on Cymbalta's use against pain caused by osteoarthritis.

Three studies submitted by Lilly showed that Cymbalta lowered patient-reported pain scores significantly more than placebo after three months.

But in its review posted online, FDA scientists said Lilly's methodology still appeared "problematic." Specifically, the company included positive feedback data from patients who later dropped out of the study, possibly because of side effects to the drug. According to FDA reviewers, this practice could "potentially assign good pain scores to subjects who could not tolerate the drug."

The FDA also has concerns about widening use of a drug associated with serious liver toxicity. Cymbalta already carries a warning label about liver toxicity risks based on more than a dozen reports from patients taking the drug.

According to FDA records, use of Cymbalta has already expanded threefold — from 5 million in 2005 to 14.6 million last year — as the drug has picked up additional indications.

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Pfizer Seeking to Duck Prempro Cancer Liability, Lawyer Argues at Trial

Quoted from http://www.bloomberg.com/news/2010-08-17/pfizer-seeking-to-duck-prempro-cancer-liability-lawyer-argues-at-trial.html

Pfizer Seeking to Duck Prempro Cancer Liability, Lawyer Argues at Trial

By Jef Feeley - Aug 17, 2010

A Pfizer Inc. unit is seeking to duck responsibility for two women’s breast cancers linked to its Prempro menopause drug, a lawyer argued at the end of a trial.

Pfizer’s Wyeth subsidiary rejected Sharon Buxton’s and Joy Henry’s claims that its hormone-replacement medicine helped cause their cancers in the face of a wealth of evidence to the contrary, Zoe Littlepage, a lawyer for the women, told a state court jury today in Philadelphia.

“Wyeth accepts responsibility for not a single breast cancer,” Littlepage said in closing arguments in the trial of the two women’s lawsuit against the drugmaker. The pair seek at least $100,000 total in damages in the first phase of the case.

More than 6 million women took the menopause drugs to treat symptoms such as hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, topped $2 billion before the Women’s Health Initiative, a National Institutes of Health-sponsored study, concluded they posed an increased cancer risk.

Until 1995, many menopausal women combined Premarin, Wyeth’s estrogen-based drug, with Upjohn’s progestin-laden Provera, to relieve their symptoms. Wyeth later combined the two hormones in its Prempro pill.

Wyeth’s witnesses testified during the five-week trial that researchers haven’t conclusively found Prempro causes breast cancer, and Buxton’s and Henry’s lawyers didn’t produce enough evidence linking their cancers to the drug to win, Beth Wilkinson, one of the company’s attorneys, told jurors.

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Bayer Said to Pay $60 Million to Settle Suits Over Bleeding-Control Drug

Quoted from http://www.bloomberg.com/news/2010-08-17/bayer-said-to-pay-60-million-to-settle-suits-over-bleeding-control-drug.html

Bayer Said to Pay $60 Million to Settle Suits Over Bleeding-Control Drug

By Jef Feeley - Aug 17, 2010 12:04 PM ET

Bayer AG agreed to pay at least $60 million to settle about 150 lawsuits over Trasylol, a drug used to control bleeding during heart surgeries, people familiar with the accords said.

The settlements, which Bayer announced in court earlier this month, provide an average payout of about $400,000 per patient, said three people familiar with the agreements who weren’t authorized to speak publicly about them. Bayer pulled Trasylol off the market in 2007 after researchers found the medicine posed a higher risk of death than competing drugs.

Bayer halted Trasylol sales after studies linked the product to a 50 percent higher risk of death than rival treatments in patients undergoing heart surgery. Trasylol was approved in the U.S. in 1993 to reduce bleeding and cut the need for transfusions during open-heart surgery.

“After thorough examination of each case, Bayer will, at times, consider the option of settling litigation on a case-by- case basis,” Marcy Funk, a Bayer spokeswoman, said in an e- mailed statement. She declined to comment on the size of the settlements.

Sales of the injectable drug were 230 million euros ($292 million) in 2005, before falling 34 percent the next year after researchers raised safety concerns. Studies in 2006 and 2007 found the drug may cause kidney damage, heart attacks and strokes, according to a February filing with the U.S. Securities and Exchange Commission.

1,600 Suits

Leverkusen, Germany-based Bayer faces at least 1,600 suits alleging the company hid Trasylol’s risks from patients and doctors, according to Bayer’s SEC filing. The vast majority of those cases have been consolidated before a federal judge in Florida, for pre-trial proceedings.

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Neb. man sues makers of Rituxan after infection

Quoted from http://www.google.com/hostednews/ap/article/ALeqM5jjaVp6V9RAWYsijtXGqqRaxyFEvgD9HHIP4O1

Neb. man sues makers of Rituxan after infection

By TIMBERLY ROSS (AP) – August 12, 2010

OMAHA, Neb. — An Omaha man who contracted an infection that rendered him a quadriplegic after taking the immunosuppressant Rituxan says the drug's makers knew of the risk but didn't warn users right away, according to a federal lawsuit filed Wednesday.

Jesse Peetz, 23, said in court documents that he began taking Rituxan in 2003 for treatment of an autoimmune disorder, but that he hadn't known the drug would make him more susceptible to untreatable infections. In September 2005, he developed a near-fatal viral infection that cost him his motor function.

The lawsuit filed in U.S. District Court in Nebraska claims Genentech Inc. and Biogen Idec were negligent and failed to warn users of Rituxan's dangers until 2007.

Caroline Pecquet, a spokeswoman for South San Francisco, Calif.-based Genentech Inc., said Wednesday that the company is "committed to ethical and legal promotional practices," but declined to comment on the specifics of Peetz's lawsuit.

Pecquet also said 2 million people worldwide have used Rituxan in the 12 years its been on the market.

A message left Wednesday with Cambridge, Mass.-based Biogen Idec wasn't immediately returned.

Rituxan, according to the drug's website, is approved to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis. Its risks include fatal reactions from infusion, kidney failure and serious brain infection.

Peetz was diagnosed with the autoimmune disorder thrombotic thrombocytopenia purpura in 1995, at age 11. According to the lawsuit, by 2003 Genentech and Biogen Idec were marketing Rituxan as an off-label treatment for Peetz' condition, meaning the Food and Drug Administration had not approved it for that use.

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