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Health Highlights: July 22, 2005

Guidant Says Defibrillator Recommendation May Be Harmful Drug Industry Proposes Ad Revisions 6 Floridians Died From Generator Exhaust After 2004 Hurricanes 3 Deaths Linked to Recalled Medical Pumps Medicare to Offer Doctors a Free Electronic Records System

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

Guidant Says Defibrillator Recommendation May Be Harmful

Guidant Corp. said Friday that one of its recommendations designed to correct a problem with its implantable heart defibrillators may actually increase risk to patients.

The Indianapolis-based company had recalled 11 models of its defibrillators last month, affecting about 88,000 devices, because of malfunctions in the pacemaker-like devices. The malfunctions occurred when a magnetic switch inside the device got stuck and prevented the device from providing treatment. Defibrillators shock the heart back into a normal rhythm when they detect abnormal heartbeats.

Guidant said Friday that it has now changed its advice to doctors treating about 21,000 patients with implanted Ventak Prism AVT, Vitality AVT, and Contak Renewal AVT defibrillators, according to the Associated Press.

In June, the company had told doctors to make a programming change to the devices, which malfunctioned in two reported cases. However, the company found that a third event occurred after the original warnings went out despite the programming recommendation. The patient was not injured beyond having to have the device replaced.

In a "corrective action" letter to doctors Friday, the company warned, "Guidant has determined that one of our original recommendations -- programming Atrial Tachy Episode Data Storage to 0 percent -- can cause latching in a subset of AVT devices that have previously stored atrial episode data." Instead, the letter said, doctors "as soon as possible" should call back any patients who were reprogrammed to 0 percent or less than 20 percent and program the data storage to 20 percent.


Drug Industry Proposes Ad Revisions

The pharmaceutical industry has proposed new guidelines that call for educating doctors about new drugs before ads for them are released.

But the draft code stops short of setting a time span between a drug's release and the beginning of ads, as had been called for by industry critics who say doctors need time to understand drugs before patients start asking for them, The New York Times reported. The guidelines say only that drug makers should have "conversations with physicians" before advertising new products.

The guidelines, whose final wording is still being worked out, try to address growing pressure from a variety of fronts, including Capitol Hill and the American Medical Association, and even from within the industry itself.

A large consumer group reacted on Thursday with skepticism to the industry guidelines. "It appears the pharmaceutical industry has produced a placebo rather than supporting real reform of drug advertising," said Rob Schneider of Consumers Union, who called the guidelines primarily a good-will gesture aimed at calming Congress.

Details of the code will be disclosed at a news conference next month, the newspaper reported.

The guidelines, adopted unanimously by the Pharmaceutical Research and Manufacturers of America's board Thursday, also call for TV ads appropriate for the audience and age, ads that promote disease awareness, and ads that notify patients about low-cost drugs for the uninsured.


6 Floridians Died From Generator Exhaust After 2004 Hurricanes

At least six people in Florida were killed by portable generator exhaust in the wake of last year's four major hurricanes that left millions without power, the U.S. Centers for Disease Control and Prevention said in a report released Thursday.

Misplacement of the gasoline-powered generators led to the carbon monoxide (CO) deaths of at least six people and caused non-fatal cases of CO poisoning in at least 167 others, the agency said in its Morbidity and Mortality Weekly Report.

The CDC said the tolls may have been higher because it measured statistics from a sample of 10 hospitals. Between Aug. 13 and Sept. 25 last year, the state was battered by a record four major hurricanes: Charley, Frances, Ivan, and Jeanne.

The agency reminded the public that these generators should never be used indoors, in garages, or outdoors near windows. A typical 5.5 kW generator produces as much carbon monoxide -- an odorless, colorless gas that can kill within minutes -- as six idling cars, the CDC said. Symptoms of CO poisoning include headache, nausea, dizziness, vomiting, shortness of breath, and loss of consciousness.

In a related report, the CDC said 48.7 percent of Florida residents had no evacuation plan before any of the hurricanes; this included people in the direct paths of the storms. The agency called on the state and local governments to do a better job of devising hurricane-preparedness programs.


3 Deaths Linked to Recalled Medical Pumps

Baxter Healthcare is recalling all models of its Colleague Volumetric Infusion Pumps that could shut down while delivering vital fluids or medications to patients, the U.S. Food and Drug Administration said Thursday.

Baxter has reports of three deaths and six serious injuries associated with the pumps. The FDA issued a statement saying it has categorized the recall as Class I, its most serious recall in which there is a reasonable likelihood that the product could cause death.

Affected models include: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R. In addition to the shut-down problem, the FDA said users might inadvertently press the on/off key instead of the start key when attempting to start an infusion.

Some 255,000 of these pumps are now in use, including 206,000 distributed in the United States. They have been sold to physicians, hospitals, pharmacies, and other medical facilities.

Consumers who have questions about the recall should contact Baxter Healthcare at 800-422-9837. Those with technical questions should call the company at 800-THE-PUMP (800-843-7867).


Medicare to Offer Doctors a Free Electronic Records System

Medicare will soon offer U.S. doctors free software that will allow them to computerize their patient records, The New York Times reported Thursday.

An office with five doctors could save more than $100,000 by choosing the software provided by Medicare rather than buying a similar product from a private provider, the newspaper said. Medicare has said it considers lack of electronic records a major impediment to improving health care.

The software is a version of a program called Vista, which has been used for 20 years by hospitals and doctors associated with the U.S. Department of Veterans Affairs, the Times said.

However, the program has a history of being difficult to install, the newspaper said, which is why Medicare will also provide doctors with a list of companies that have been trained to install and maintain it.

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