Health Headlines - August 24

FDA Wants Drug Registrations, Listings Submitted Electronically

A new rule to automate all drug registration and listing in the United States was proposed Wednesday by the U.S. Food and Drug Administration. Under the proposal, all drug developers and manufacturers would be required to submit information electronically, rather than on paper.

The Electronic Drug Registration and Listing System would make the entire list of drug products sold in the United States accessible electronically. Currently, part of that list, which includes 120,000 products, is kept on paper.

"Having drug makers submit drug information electronically will help to keep an accurate, up-to-date inventory of drugs on the market. This will help us maintain more accurate information and make it easier for us to respond to drug emergencies such as recalls and drug shortages," U.S. Health and Human Services Secretary Mike Leavitt said in a prepared statement.

Along with the FDA, the list is used by other government agencies, health-care providers and health-care payers. The list contains up-to-date information about specific drug formulations and manufacturers.

Mixed Results for Vioxx Successor Drug

A preliminary analysis of study data reveals mixed results for the experimental arthritis drug Arcoxia, Merck & Co.'s follow-up to its discontinued Vioxx medication.

Vioxx was taken off the market in 2004 because it was linked to increased risk of heart attack and stroke.

A series of studies that compared Arcoxia (a COX-2 inhibitor) to the nonsteroidal anti-inflammatory drug (NSAID) diclofenac found that patients taking Arcoxia didn't have a significantly greater risk of heart attack than patients taking diclofenac, the Associated Press reported.

However, at certain doses, more patients in the Arcoxia group had to withdraw from the research due to high blood pressure and swelling. But in the diclofenac group, many more patients had to drop out due to liver and gastrointestinal problems.

Merck said this is consistent with earlier study results. The complete findings of the Arcoxia research will be published in medical journals and presented at upcoming scientific meetings, the AP reported.

COX-2 inhibitors, including Vioxx, were developed to replace NSAIDs, which can cause stomach problems such as ulcers. Celebrex is the only COX-2 on the market; Bextra was withdrawn from the market after similar concerns about heart risks.

In 2004, the U.S. Food and Drug Administration issued an approvable letter for Arcoxia. An approvable letter requests more information or research before the FDA considers giving final approval.

Canada Confirms New Mad Cow Case

A new case of mad cow disease in Canada was confirmed Wednesday, making it the fifth case in the country this year and the eighth since 2003, CBC News reported.

The latest case is in the province of Alberta and involves a cow believed to be old enough (8 to 10 years) to have contracted the disease before Canada banned the use of cattle parts in cattle feed, said the Canadian Food Inspection Agency (CIFA).

No part of the infected cow entered the human or animal feed systems, officials said.

CIFA is trying to determine where the cow was born, verify its age, identify other cows from the herd, and determine possible sources of contaminated feed, CBC News reported.

Genetic Blueprints of Flu Viruses Made Public

Hoping to boost flu research, the U.S. Centers for Disease Control and Prevention last week put the genetic blueprints of more than 650 flu viruses in a public database accessible to researchers around the world.

The information was added to an influenza database housed at the Los Alamos National Laboratories and to Genbank, a public-access library for virus sequences that's managed by the U.S. National Institutes of Health.

The information about naturally circulating viruses in the United States includes data from the annual flu season, animal flu viruses that infect people, and new flu strains (such as bird flu) that may emerge in the United States.

"With more information, the world's influenza experts can advance our understanding of the viruses circulating, potentially create new prevention strategies and treatments, and ultimately help us better protect the health of people around the world," Dr. Nancy Cox, director of the CDC's Influenza Division, said in a prepared statement.

Previously, access to genetic data about flu viruses was limited to a small number of scientists who work together with the World Health Organization.

Human Tissues Recalled by Colorado Firm

Hundreds of human tissue products destined for transplants into patients across the United States have been recalled by a Colorado tissue provider, AlloSource.

The recalled products were supplied by a North Carolina body parts broker who used an unsterile embalming room to extract tissue from dozens of corpses, the Associated Press reported.

Last Friday, the U.S. Food and Drug Administration closed down the body broker, Donor Referral Services of Raleigh, N.C. But the FDA would not disclose how many people have received potentially unsafe tissue from the broker.

Cadaver tissue is used in more than a million transplants -- including for knee surgery and back repair -- in the United States each year. But tissue that's not properly processed or tested can lead to infections such as hepatitis or HIV/AIDS, or even death, the AP reported.

This is the second incident to rock the U.S. tissue transplant industry in less than a year. In 2005, Biomedical Tissue Services of New Jersey was accused of using stolen bodies and of shipping about 20,000 potentially tainted body parts.

Medicare Reimbursement Glitch Affects 230,000

About 230,000 Medicare recipients were erroneously reimbursed for monthly premiums they paid this year for prescription drug coverage, the chief of the U.S. agency that administers the program says.

The glitch was caught just after the checks -- totaling nearly $50 million -- were sent out last week, officials said. A follow-up letter was then sent to alert recipients about the problem. The average overpayment was $215, the Associated Press reported.

People who get the check need to know two things, said Mark McClellan, chief of the Centers for Medicare and Medicaid Services. First, the money has to be returned. Second, their prescription drug coverage will continue.

He promised that insurers who administer the new drug benefit will continue to be paid for beneficiaries affected by the error, the AP reported.