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FDA Announces New Drug Safety Measures

In a statement issued this week, the U.S. Food and Drug Administration (FDA) announced a renewed commitment to its drug safety system. Based on recommendations from a report by the Institute of Medicine (IOM), the agency outlined a series of immediate steps to ensure their safety procedures are as robust as they need to be.

“Our ongoing assessment of the drug and medical product safety system has affirmed that it is essential that our processes and scientific methods keep pace with the rapid evolution of science, technology and the health care system,” said Dr. Andrew C. von Eschenbach, commissioner of the FDA. “The extensive input we have received from stakeholders has proven invaluable as we transform the drug and medical product safety system and continue to fulfill our mission to protect and promote the public health.”
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BBC: Glaxo Hid Safety Concerns Related to Seroxat (Paxil)

According to journalists at the BBC, GlaxoSmithKline intentionally distorted and covered up damaging information about their antidepressant Seroxat and its link to an increased risk of suicide in children. Researchers for the BBC documentary series Panorama obtained three critical documents suggesting that the company had conducted trials proving the drug was unsafe, but failed to accurately disclose that information. (Seroxat is a brand name for paroxetine, a selective serotonin reuptake inhibitor (SSRI) class of antidepressant marketed in the U.S. as Paxil.)

The BBC’s website reports: “GSK’s biggest clinical trial of Seroxat on children was held in the U.S. in the 1990s and called Study 329. Child psychiatrist Dr. Neal Ryan of the University of Pittsburgh was paid by GSK as a co-author of Study 329. In 2002, he also gave a talk on childhood depression at a medical conference sponsored by GSK. He said that Seroxat could be a suitable treatment for children and later told Panorama reporter Shelley Jofre that it probably lowered rather than raised suicide rates.”
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Wyeth Loses Prempro Suit

Pharmaceutical giant Wyeth was ordered by a Pennsylvania state jury to pay $1.5 million in compensatory damages to an Arkansas woman and her husband who held the company’s hormone replacement therapy (HRT) drug Prempro responsible for the woman’s breast cancer. Citing conduct by Wyeth that was “malicious, wanton, willful, or oppressive, or showed reckless indifference,” the jury has also begun deliberating on possible punitive damages to be tacked on. However, Judge Myrna Field ruled Tuesday that the company should not be held responsible for punitive damages a decision that may be overturned in the appeals process.

Mary Daniel, 60, of Hot Springs, Arkansas, began taking Prempro, a drug that combines estrogen and progestin, to treat the symptoms of menopause. Daniel started her therapy in late 1999 and was diagnosed with breast cancer in July of 2001. Her attorneys argued that Wyeth had known for decades about Prempro’s breast-cancer risk factor in postmenopausal women, but acted negligently by failing to provide adequate warnings or conduct sufficient testing.
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Judge Rejects State Farm Settlement

In another apparent legal blow to State Farm Fire & Causalty Co., U.S. District Judge L.T. Senter rejected a Mississippi class-action settlement related to Hurricane Katrina damage, claiming that the proposed settlement favored the needs of the insurance company over those of the policyholders.

Senter asked for more information before he would approve the deal. “In the absence of substantially more information than I now have before me, I am unable to say, even preliminarily, that the proposed settlement establishes a procedure that is fair, just, balanced, or reasonable,” he said in his decision.
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Amgen’s Anemia Drug Aranesp Carries Risk in Cancer Patients

In a letter sent last week to medical professionals and posted by the U.S. Food and Drug Administration (FDA), drug maker Amgen warned of an elevated risk of fatalities associated with the use of their anemia drug, Aranesp (darbepoetin alfa), in cancer patients. Amgen conducted a clinical trial to test the safety and efficacy of Aranesp on patients whose anemia was caused by cancer, hoping to expand the approved usage of the drug to include that indication.

Amgen warned that “Aranesp was ineffective in reducing RBC [red blood cell] transfusions in patients with cancer who have anemia that is not due to concurrent chemotherapy. In addition, this study showed higher mortality in patients receiving Aranesp.” The Phase 3, double-blind, randomized, placebo-controlled study included 989 patients with active cancer and low hemoglobin levels, but who weren’t receiving chemotherapy or radiotherapy. In the 16-week treatment phase, more deaths were reported in the Aranesp treatment group (26 percent) than the placebo group (20 percent).
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Genentech Issues Warning About Eye Drug Lucentis

In a letter sent to 1,500 eye doctors, Genentech is warning that its macular degeneration drug, Lucentis, may increase the risk of stroke if administered in high doses. Approved a mere six months ago by the FDA, Lucentis has already generated nearly $400 million in sales for Genentech, although the latest news may hurt the drug’s economic performance.

The company announced that preliminary findings from a 5,000-patient trial found that 1.2 percent of patients taking high doses (0.5 mg) of Lucentis suffered a stroke while only 0.3 percent of low-dose (0.3 mg) patients had a stroke. The difference in dosages does not appear to affect the incidence of heart failure.
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Trasylol Clinical Trials Halted

Bayer HealthCare announced it is discontinuing three clinical trials for their drug, Trasylol, citing recent FDA-approved label changes. Bayer was hoping to expand the approved usage of the drug, which currently is only approved for use in the course of coronary artery bypass graft surgery.

The trials were set up to investigate the safety and efficacy of Trasylol (aprotinin injection) in adults undergoing spinal-fusion surgery, pneumonectomy (removal of lung) or esophagectomy (removal of esophagus) for cancer, and radical or total cystectomy (removal of bladder) for cancer. The drug is intended to help stop blood loss and reduce the need for blood transfusions.
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Study: Long-Term Cell Phone Use May Be Linked to Brain Tumors

For the past decade or more, many people have feared that excessive cell-phone usage may lead to an increased risk of developing brain tumors. Yet, that hypothesis has never been proven. A new European study, to be published in next month’s International Journal of Cancer, may very well bring the issue to the forefront.

Researchers from the United Kingdom, Sweden, Denmark, Norway, and Finland conducted a case-control study to “investigate the relationship between mobile phone use and risk of glioma [brain tumors] among 1,522 glioma patients and 3,301 controls.” Their overall findings suggest that there is “no evidence of increased risk of glioma related to regular mobile phone use.” They also reported that “no significant association was found across categories with duration of use, years since first use, cumulative number of calls, or cumulative hours of use.”
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Executive Order Gives White House More Regulatory Power

Few people may have noticed, but the White House recently handed down a decree that may have significant effects on several areas of federal regulation in the United States. Last week, President George W. Bush issued new amendments to Executive Order 12866 on Regulatory Planning and Review, and critics fear that the move is simply a power grab aimed at protecting the interests of industry and commerce.

Specifically, the amendments expand the power of the White House’s Office of Information on Regulatory Affairs (OIRA), which is part of the Office of Management and Budget (OMB). There are three major aspects to the changes. First, the President has expanded OIRA oversight to include “guidance documents” in addition to regulations. Secondly, the new Executive Order now includes specific language related to “market failures”–in other words, it forces federal agencies to become more reliant on free-market forces to correct regulatory problems. Finally, it calls for federal regulatory agencies to consider “the combined aggregate costs and benefits of all its regulations planned for that calendar year to assist with the identification of priorities.”
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FDA Backs Off New Birth-Control Guidelines

This week, the U.S. Food and Drug Administration’s Reproductive Health Drugs Advisory Committee held a two-day meeting to discuss, among other items, the possibility of implementing new standards of effectiveness for hormonal contraceptives. However, while the panel encouraged drug manufacturers to conduct post-market studies to determine the products’ safety, they stopped short of setting new guidelines with regard to their efficacy.

The major hurdle facing the FDA is finding a balance between safety and efficiency. Newer contraceptives have been shown to carry with them fewer side effects, but have also proven to be, in some cases, half as effective in preventing pregnancies as their older counterparts. Panelists decided that consumers should be offered a range of treatment options, and therefore, they are reluctant to recommend any hard-and-fast guidelines in terms of effectiveness.
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