Drug Safety Developments

After Avandia: Does the FDA Have a Drug Problem?

Quoted from http://www.time.com/time/health/article/0,8599,2010028,00.html

After Avandia: Does the FDA Have a Drug Problem?

By Massimo Calabresi with Alice Park Thursday, Aug. 12, 2010

Five days before a 2007 article in the New England Journal of Medicine showed that the diabetes drug Avandia was linked to a 43% increase in heart attacks compared with other medications or placebos, a group of scientists and executives from the drug's maker, GlaxoSmithKline (GSK), gathered in a conference room at the offices of the Food and Drug Administration in White Oak, Md. The GSK goal: to convince regulators that the evidence that the company's $3 billion-a-year blockbuster drug caused heart problems was inconclusive. To do that, the GSK officials focused not on heart-attack data but on a broader, less well defined category of heart problems called myocardial ischemia. The most recent studies of Avandia, the GSK officials told the FDA, had "yielded information that is inconsistent with an increased risk of myocardial ischemic events," according to sealed court proceedings obtained by TIME.

What GSK didn't tell the FDA was that on May 14, 2007, two days before the White Oak meeting, GSK's Global Safety Board had noted that a new assessment of Avandia studies "strengthens the [cardiac-risk] signal observed in the [previous] analysis." Or that eight days earlier, the company's head of research and development, Moncef Slaoui, had sent an e-mail to its chief medical officer saying Avandia patients showed an "increased risk of ischemic event ranging from 30% to 43%!" Or that the day before the meeting, the company had produced a preliminary draft report that showed patients on Avandia had a 46% greater likelihood of heart attack than those in a control group.

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Hormones and breast cancer: What women should consider

Quoted from http://pagingdrgupta.blogs.cnn.com/2010/08/10/hormone-and-breast-cancer-what-women-should-consider/

Hormones and breast cancer: What women should consider

Over the years, numerous studies have shown that hormone replacement therapy (HRT) increases a woman's risk of developing breast cancer. But to many women, questions about side effects, hormone combinations and length of hormone use are still unanswered, causing confusion. And some continue to take hormones to relieve menopausal symptoms because they don't know where they fall in the HRT spectrum.

In an attempt to clarify the risks versus the benefits, a report published in Cancer Epidemiology, Biomarkers and Prevention, and conducted by researchers at the University of Southern California, looked at data from a large trial group, called the California Teachers Study. Investigators were particularly interested in the more than 2,800 women in the study who were diagnosed with breast cancer.

When looking at hormone use, investigators found women who reported using just estrogen therapy for 15 years or more had a 19 percent greater risk of breast cancer compared with women who never used hormone therapy. And for women who used anestrogen and progestin combination or EPT for more than 15 years, their risk of developing breast cancer jumped to 83 percent.

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AstraZeneca Pays $198M To Settle US Seroquel Claims

Quoted from http://online.wsj.com/article/BT-CO-20100809-702486.html

AstraZeneca Pays $198M To Settle US Seroquel Claims

AUGUST 9, 2010

By Simon Zekaria Of DOW JONES NEWSWIRES

LONDON (Dow Jones)--U.K. pharmaceutical group AstraZeneca PLC (AZN.LN) said Monday it has reached a $198 million settlement over claims regarding its best-selling antipsychotic drug Seroquel in the U.S.

AstraZeneca has faced thousands of product-liability lawsuits alleging that the use of Seroquel caused diabetes and other injuries, and that the company failed to adequately warn of the drug's risks.

 

The group has also faced long-running allegations it improperly promoted the drug, which is approved to treat schizophrenia, bipolar disorder and depression.

 

The settlement relates to 17,500 product liability claims, and the company said the mediation process over claims is ongoing in both federal and state jurisdictions.

 

"We remain committed to a strong defense effort, but will also continue to participate in good faith in court-ordered mediation," the company said in a statement.

 

Federal prosecutors and authorities from several U.S. states have been probing allegations AstraZeneca promoted Seroquel off-label, or for uses not approved by the U.S. Food and Drug Administration. In April, the company announced a settlement of $520 million with the U.S. Justice Department over the matter.

 

Astrazeneca Monday said that, as of June 29, approximately 2,900 additional claims had been dismissed by order or agreement.

 

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Abbott's weight-loss drug to be reviewed by FDA panel

Quoted from http://www.chicagobusiness.com/article/20100806/NEWS03/100809909/abbotts-weight-loss-drug-to-be-reviewed-by-fda-panel

Abbott's weight-loss drug to be reviewed by FDA panel

August 06, 2010 

(Reuters) — Abbott Laboratories' weight loss drug Meridia will be reviewed by an advisory panel to the U.S. Food and Drug Administration on September 15, the company said on Friday.

The meeting will take place a day before the Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review lorcaserin, an experimental obesity drug being developed by Arena Pharmaceuticals Inc. and Eisai Co Ltd.

Abbott suspended European sales of Meridia, or sibutramine, in January after a recommendation by regulators that heart-related risks made the prescription drug too dangerous.

Abbott spokesman Scott Davies said on Friday that Abbott reiterates its view of Meridia's "positive risk/benefit profile" when used in the patient population for which the drug is approved.

Meridia's global sales were about $300 million in 2009.

An FDA panel last month voted to recommend that a weight loss drug called Qnexa, being developed by Vivus Inc., not be approved by the agency due to concerns that it could cause depression, memory loss and potential birth defects if used among millions of overweight or obese Americans.

Roche Wins Reversal of $10.5 Million Accutane Verdict in New Jersey Case

Quoted from http://www.bloomberg.com/news/2010-08-05/roche-wins-reversal-of-10-5-million-accutane-verdict-based-on-judge-error.html

Roche Wins Reversal of $10.5 Million Accutane Verdict in New Jersey Case

By Jef Feeley - Aug 5, 2010 7:24 PM ET

Roche Holding AG won reversal of a $10.5 million verdict over its Accutane acne drug because a judge improperly barred the company from using evidence about the medication’s use, an appeals court ruled.

Roche’s lawyers should have been able to use data about how many acne sufferers had used Accutane over the years throughout Kamie Kendall’s 2008 trial of her lawsuit over the drug, the New Jersey Superior Court Appellate Division ruled today. The decision prompted a judge in Atlantic City, New Jersey, to delay the trial of an actor’s suit alleging the medication causes inflammatory bowel disease.

“Roche was unduly impeded at this trial from adducing and advocating numerical proofs that could have potentially and reasonably led a jury to reach a different verdict,” the appeals court said in an 89-page unpublished decision.

About 13 million people have taken Accutane, once Roche’s second-biggest selling drug, since it went on the market in 1982. Roche, based in Basel, Switzerland, lost patent protection on the drug in 2002 and continued to sell it along with generic competitors. In addition to bowel disease, Accutane has been linked to birth defects and depression.

Roche, the world’s biggest maker of cancer drugs, pulled its brand-name Accutane off the market in 2009 after juries awarded millions of dollars in damages to former users over the bowel-disease claims.

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AstraZeneca Said to Pay $55 Million to Settle 5,500 Lawsuits Over Seroquel

Quoted from http://www.bloomberg.com/news/2010-08-04/astrazeneca-said-to-pay-55-million-to-settle-5-500-lawsuits-over-seroquel.html

AstraZeneca Said to Pay $55 Million to Settle 5,500 Lawsuits Over Seroquel

By Jef Feeley and Phil Milford

Aug 4, 2010

AstraZeneca Plc, the U.K.’s second- biggest drugmaker, agreed to pay about $55 million to settle around 5,500 lawsuits related to side effects of the antipsychotic Seroquel, people familiar with the accords said.

The settlements, with an average payout of about $10,000 per case, resulted from mediation involving 26,000 suits filed over Seroquel, the people said. The London-based company previously agreed to pay $2 million to resolve more than 200 allegations that Seroquel causes diabetes in some users, people familiar with those accords said last month.

AstraZeneca is moving to resolve Seroquel claims as it faces expiring patents on the drug and the ulcer treatment Nexium in the next four years. Seroquel, the company’s second- biggest seller after Nexium, generated sales of $4.87 billion last year, or 15 percent of AstraZeneca’s total revenue.

The 5,500 settlements include 4,000 that AstraZeneca acknowledged in a July 29 regulatory filing, the people said. The company hasn’t disclosed terms of the accords and wouldn’t comment on them yesterday. The settlements stemmed from mediation ordered by the judge in Orlando, Florida, who was overseeing all federal-court litigation over the drug.

AstraZeneca “continues to participate in good faith in the mediation process, with multiple mediation sessions scheduled throughout the summer,” Tony Jewell, a company spokesman in Wilmington, Delaware, said in an e-mailed statement. He declined to comment further, citing the mediator’s request for confidentiality.

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Roche to Face Hollywood Stars in Accutane Trial

Quoted from http://www.businessweek.com/news/2010-07-30/roche-to-face-hollywood-stars-in-accutane-trial.html

Roche to Face Hollywood Stars in Accutane Trial

July 30, 2010, 12:43 PM EDT

By Jef Feeley

 

July 30 (Bloomberg) -- Roche Holding AG faces a lineup of Hollywood stars in the New Jersey trial of an actor’s lawsuit alleging he suffered the loss of his colon after taking the company’s Accutane acne drug.

James Marshall, who played U.S. Marine Louden Downey in the 1992 hit movie “A Few Good Men,” claims his acting career was derailed by his use of Accutane, which Roche no longer sells. Marshall will ask a jury to award at least $11 million in damages at a trial starting next week that will feature testimony from stars such as Martin Sheen and Brian Dennehy, according to court filings.

Sheen, Dennehy and director Rob Reiner will testify that Marshall, 43, was headed for stardom before bowel ailments allegedly caused by Accutane forced doctors to remove his colon, Michael Hook, the actor’s lawyer, said in an interview. Basel, Switzerland-based Roche faces thousands of lawsuits claiming it failed to warn patients that the drug could cause inflammatory bowel disease in some users, Hook said.

“The jury will hear that James Marshall had the potential to be the next James Dean-like star,” Hook said. “That dream is gone because he took something to treat acne.”

Roche said today that Accutane’s safety label has warned about the risks of inflammatory bowel disease for more than 20 years.

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AstraZeneca Settlement Terms in Almost 4,000 Seroquel Cases to Stay Secret

Quoted from http://www.bloomberg.com/news/2010-07-30/astrazeneca-says-almost-4-000-seroquel-claims-settled-through-mediation.html

AstraZeneca Settlement Terms in Almost 4,000 Seroquel Cases to Stay Secret

By Phil Milford and Jef Feeley - Jul 31, 2010

AstraZeneca Plc, which tentatively settled almost 4,000 product-liability cases this month involving its antipsychotic drug Seroquel through mediation, said it will keep terms of the agreements confidential.

“AstraZeneca remains committed to a strong defense effort, but will also continue to participate in good faith in the court-ordered mediation process,” Tony Jewell, an AstraZeneca U.S. spokesman in Wilmington, Delaware, said yesterday in an e-mailed statement.

The London-based company, the U.K.’s second-biggest drugmaker, said in a regulatory filing that by the end of March, it was defending more than 10,000 cases involving 22,500 plaintiff groups. Some of the cases were previously dismissed because plaintiffs lacked sufficient evidence to support allegations that Seroquel causes diabetes.

The company, with $32.8 billion in sales last year, said in the July 29 filing that by March, it had spent about $688 million defending Seroquel-related cases.

AstraZeneca agreed earlier to pay $2 million to settle more than 200 Seroquel cases, averaging about $10,000 each, people familiar with the agreements said. Those settlements were part of the same federal-court-ordered mediation.

Some of the cases were filed in state courts, including New Jersey and Delaware. Others have been consolidated on the federal level with U.S. District Judge Anne Conway in Orlando, Florida.

In the first Seroquel case to be tried, AstraZeneca won a jury verdict that the company properly warned doctors of a Vietnam War veteran of the drug’s diabetes risk. A judge in Delaware dismissed three more cases saying there wasn’t enough proof of a diabetes link.

The consolidated Seroquel case is In re Seroquel Products Litigation, 06-MD-01769, U.S. District Court, Middle District of Florida (Orlando).