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Health Highlights: July 10, 2006

Medicare Drug Plan Insurers Don't Offer Accurate Information: GAO Report Company Seeks Approval to Test Needle-Free Bird Flu Vaccine Class I Recall for External Defibrillators U.S. to Omit Doctors' Names From Implanted Defibrillator Data Damaged Gene Doubles Breast Cancer Risk: Study Labeling of Antidepressant Used by Yates Criticized

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Medicare Drug Plan Insurers Don't Offer Accurate Information: GAO Report

Telephone call centers operated by insurers offering prescription drug coverage through the new Medicare drug plan provided complete and accurate answers only a third of the time, says a U.S. Government Accountability Office (GAO) report released Monday.

GAO investigators made 900 calls to 10 of the largest drug plan insurers and found that overall accuracy and completeness rate ranged from 20 percent to 60 percent, the Associated Press reported.

Only one insurer's call center provided proper, full answers more than 50 percent of the time.

There are 43 million people eligible for Medicare drug coverage and many of them rely on insurers' call centers for information about what plan best suits them, the AP reported.

The GAO investigators did find that most of their calls were answered with minimal delay and that the majority of operators were courteous and many offered helpful suggestions. However, operators were unable to answer 15 percent of the questions asked by the GAO investigators and operators at the same call centers sometimes provided inconsistent answers.

The results show that Medicare beneficiaries face challenges in obtaining the information they require in order to make informed choices, the GAO report noted. Officials with the agency that oversee the drug program said the GAO report was based on "inaccurate, incomplete and subjective methods," the AP reported.


Company Seeks Approval to Test Needle-Free Bird Flu Vaccine

A British company called PowderMed has applied for approval to conduct the first trial in Britain of a needle-free bird flu vaccine.

The Oxford-based company has asked for permission to test its H5N1 vaccine on 75 volunteers at a hospital in London, The Times of London, reported.

The vaccine would be administered using a needle-free system. Helium is used to propel particles coated in the section of DNA needed to make haemagglutinin protein (the H5 in H5N1) into the skin. This trial is designed to determine the correct dose to produce an immune response to protect against H5N1.

The company would be able to create a new vaccine in about 10 weeks, which is much quicker than traditional vaccines developed in chicken eggs, said John Beadle, PowderMed's chief medical officer, told The Times.

This new H5 vaccine could be licensed within the next two years, he said.


Class I Recall for External Defibrillators

An alert to emergency services personnel and risk managers about a Class I recall of Welch Allyn PIC 50 Automated External Defibrillators - catalog #97108X- was announced Monday by the U.S. Food and Drug Administration.

The devices, manufactured from March 2002 through October 2004, have an electrical contact problem that may result in failure to provide a defibrillation shock. This could result in delay or failure to resuscitate a patient, the FDA said.

The device's failure to provide a defibrillation shock may be accompanied by various error messages on the display panel, such as the "Defib Comm" error message.

A Class I recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the recalled product will cause serious injury or death.

People with questions about the recall can contact the company at (800) 462-0777 or (847) 520-0300.


U.S. to Omit Doctors' Names From Implanted Defibrillator Data

U.S. health officials were expected to publicly release data Monday showing that about 4 percent of patients who underwent heart-defibrillator implants had at least one complication during a 16-month period following the procedure.

But the Centers for Medicare and Medicaid Services has also decided for legal and policy reasons, including concerns about violating patient confidentiality, to omit data identifying the doctors involved. The agency released the data Friday in response to a Freedom of Information Act request filed last year by the New York Times.

In a story published Monday, the newspaper analyzed the statistics and found that about 4 percent of the 45,000 patients who underwent implants reported at least one complication to the agency over a 16-month period ending in April. The two most frequently reported complications were blood clots and displacement of a cable that connects the defibrillator to the heart. The implantable devices interrupt potentially fatal types of heart rhythms.

The complication rate, the Times reported, falls within the general boundaries of previous studies. But those same studies also indicated that complication rates can vary widely among doctors and hospitals based on factors such as the number of implants a doctor performs.

Currently, only New York and a few other states publicly release data comparing complication rates at hospitals in heart procedures involving surgery, the Times said.


Damaged Gene Doubles Breast Cancer Risk: Study

A damaged gene carried by about two percent of families more than doubles the risk for breast cancer by age 70, British scientists said Monday.

Researchers screened 433 patients with a family history of cancer and a control group of 521 healthy women.

A team at the Institute of Cancer Research in Sutton, England, found a correlation between the damaged gene and increased breast cancer risk. The findings could lead to new genetic tests to determine which women are more susceptible to cancer, or which drugs can help certain patients, Bloomberg News reported.

Called ATM, the gene is responsible for repairing DNA in cells. The researchers found that women with a faulty copy of the gene cannot repair damaged DNA correctly, causing the cells to replicate uncontrollably and become malignant.

The findings are published in Monday's issue of Nature Genetics.


Labeling of Antidepressant Used by Yates Criticized

The maker of the antidepressant used by Texas homemaker Andrea Yates before she drowned her five children in 2001 changed the drug's label last year to warn of homicidal thoughts as a rare side effect but failed to notify anyone, the Associated Press reported Monday.

Gwen Fisher, a spokeswoman for Wyeth, said that while Effexor was being studied to treat panic disorder, the company only found one person who reported having homicidal thoughts during its clinical trial. "Homicidal ideation" was added last year as one of the drug's rare side effects, but the company never notified doctors or issued warning labels because it found no clear link between the drug and homicidal thoughts.

"We believe there is no causal link between Effexor and homicidality," Fisher said.

But Dr. Moira Dolan, executive Medical Accountability Network, a watchdog group, criticized Wyeth for not widely publicizing the warning, saying "homicidal ideation" was buried on page 36 of Effexor XR's label. Dolan said she only learned of the label change two weeks ago after stumbling across the Food and Drug Administration's MedWatch November newsletter.

The FDA defines "rare" as occurring in less than one in 1,000 people. About 19.2 million prescriptions for Effexor were filled last year in the United States.

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