Hewlett-Packard agreed to pay $14.5 million to settle a civil case brought against it by the California Attorney General’s office related to the company’s internal investigations of its board members. The lion’s share of the settlement will be used to establish a Privacy and Piracy Fund that will help state prosecutors fight consumer privacy and piracy violations. Felony criminal charges are still pending against five people involved in the scandal, in which company investigators were accused of impersonating board members, employees, and journalists in order to obtain personal phone records.

Also as part of the settlement, HP will make several changes to its corporate governance structure: A new independent director will be the board’s watchdog with regard to ethical and legal requirements. Both the chief ethics and compliance officer and chief privacy officer will receive greatly expanded duties. The company will also establish a new Compliance Council that reports to the CEO, the board, and the audit committee.
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n a new report released yesterday, the U.S. Food and Drug Administration said that the use of antidepressants may increase suicidal thoughts and behavior in young adults between the ages of 18 and 24. The FDA analyzed data from 372 studies, which together included roughly 100,000 patients and 11 different modern drugs. The information was released in advance of next week’s public meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee.

The December 13 meeting is a follow-up to two meetings that took place in 2004. In those meetings, the panel discussed the connection between antidepressants and suicidal behavior in pediatric patients. Previous findings had shown an increased risk of suicidal thinking and behavior in children and adolescents that was associated with the use of antidepressants.
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The U.S. Food and Drug Administration (FDA) announced that it is joining the investigation of the E. coli outbreak connected to a number of Taco Bell restaurants in the Northeast. The fast-food chain has decided to pull green onions from all of its outlets after preliminary testing indicated that the outbreak may be linked to that product.

At this point, neither the FDA nor Taco Bell has confirmed that the green onions are responsible for the problem. According to an FDA statement, “FDA is obtaining samples of all non-meat items served in the restaurants that could carry the pathogen. These include cilantro, cheddar cheese, blended cheese, green onions, yellow onions, tomatoes, and lettuce. The samples will be tested at FDA laboratories. The states involved are testing as well. At this time the agency does not have data implicating or ruling out any of these items.”
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In yet another controversial move, an advisory panel of the U.S. Food and Drug Administration (FDA) voted to recommend approval of Celebrex for the treatment of juvenile rheumatoid arthritis (JRA). The recommendation comes despite a number of lingering long-term safety concerns associated with the drug, which is manufactured by Pfizer.

Approximately 60,000 children are afflicted with JRA in the United States. Fifteen of the 16 panel members voted for approval, citing the short-term benefits of Celebrex and the lack of evidence of short-term safety issues. However, in an 8-7 vote (with one abstention), the panel confirmed that the drug’s long-term safety could not be assured and they urged Pfizer to conduct long-term studies in order to prove its ultimate safety.
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n a new report released yesterday, the U.S. Food and Drug Administration said that the use of antidepressants may increase suicidal thoughts and behavior in young adults between the ages of 18 and 24. The FDA analyzed data from 372 studies, which together included roughly 100,000 patients and 11 different modern drugs. The information was released in advance of next week’s public meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee.

The December 13 meeting is a follow-up to two meetings that took place in 2004. In those meetings, the panel discussed the connection between antidepressants and suicidal behavior in pediatric patients. Previous findings had shown an increased risk of suicidal thinking and behavior in children and adolescents that was associated with the use of antidepressants.
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Five companies have been warned by the FDA to stop compounding and distributing topical anesthetic creams due to serious public health risks. According to the FDA’s new safety alert, “Exposure to high concentrations of local anesthetics, like those in compounded topical anesthetic creams, can cause grave reactions including seizures and irregular heartbeats.”

“Compounded topical anesthetic creams, like all compounded drugs, are not reviewed by FDA for safety and effectiveness, and are not FDA-approved. These high-potency drugs may expose patients to unnecessary risk, especially when they are used without proper medical supervision,” said Dr. Steven Galson, director of FDA’s Center for Drug Evaluation and Research.
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A planned FDA safety review regarding the use of drug-coated stents is facing intense scrutiny after it was revealed that six doctors on the advisory panel have financial links to stent makers Johnson & Johnson and Boston Scientific. The meeting, set for Thursday and Friday of this week, has been scheduled in order to discuss significant risks of blood clotting associated with the use of drug-coated stents. The FDA granted conflict-of-interest waivers to all six of the physicians in question.

In advance of the meeting, the FDA released documents today related to an FDA staff review that noted that the drug-coated stents “are associated with a small but significant risk of late-stent thrombosis.” Stents are wire-mesh devices used to unclog arteries. The drug-coated stents are intended to prevent scar tissue from forming in the arteries, but preliminary research has determined that the coated stents may increase the probability of adverse events, including heart attacks and strokes.
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The popular Mexican fast-food outlet Taco Bell temporarily closed nine stores in New York and New Jersey due to fears of E. coli contamination. So far, there have been 25 confirmed cases of food poisoning in New Jersey and 14 more in Long Island. Eight of the stores–four in New York’s Nassau County and four in Suffolk County–are slated to reopen after health officials and restaurant representatives declared that the threat had passed, and one outlet in New Jersey should reopen shortly.

There has not been a definitive connection made between the outbreak and the eateries, but the large majority of the infected patients had eaten at Taco Bell prior to being sick. All of the closed stores use the same distributor. There have been no reported cases of E. coli infection since November 29.
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In a major stumbling block for the world’s largest drug manufacturer, Pfizer announced over the weekend that it is halting all research and development on torcetrapib, their highly anticipated new cholesterol drug. In a press release, the company stated that it was immediately stopping all clinical trials of the drug after the independent Data Safety Monitoring Board (DSMB) “recommended terminating the study because of an imbalance of mortality and cardiovascular events.”

According to the FDA, “The DSMB was conducting a monthly analysis of mortality data and a quarterly analysis of a number of outcomes including stroke, heart attack, and revascularizations (e.g., coronary stents or bypass surgery) to ensure the ongoing safety of patients in this trial.” However, the DSMB found an “increased rate of mortality” among patients who’d been taking both torceptrapib and atorvastatin (Lipitor) in the trials when compared to those only taking Lipitor.
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The Archdiocese of Los Angeles, the largest Roman Catholic archdiocese in the country, announced on Friday a $60 million settlement covering 45 clergy sex-abuse cases. However, the number of cases settled by the new agreement amounts to less than 10 percent of the total cases brought against the organization, and more than 500 other cases still await settlement.

The 45 settled cases are from incidents that took place before 1954, when the group arranged for liability insurance, and since 1986, the year when the group’s liability insurance ended. Lawyers are still negotiating over which, if any, church documents related to the abuse cases will be released to the public.
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