Health Highlights: Dec. 26, 2005

Documents Show Company Knew of Defibrillator's 'Life-Threatening' ProblemsNew England Flu Vaccine Distribution Inadequate, Report SaysFired NIH Whistle-Blower Reinstated Poor Nutrition Hurts Early School Achievement, Study ShowsNew Rheumatoid Arthritis Drug Approved, Maker Says

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

Documents Show Company Knew of Defibrillator's "Life-Threatening" Problems

Officials of a company that makes an electronic device designed to shock an irregular heartbeat back to normal were aware that it had deficiencies that could be "life threatening," The New York Times reports.

The newspaper, which has been tracking the problems with Guidant Corporation's defibrillator since the company recalled the model known as the Prizm 2 DR in June, reports that internal documents written in 2002 indicated that some patients might die because of short circuits. But the company never publicized the possible defect because its experts decided that the overall failure rate was acceptable.

The documents became public when they were filed last week in a Texas personal injury lawsuit. Lawsuits have also been filed in Pennsylvania and New York.

The issue came to public attention in May when the Times reported that Guidant had not told doctors for three years about more than two dozen cases in which its implantable defibrillator models, the Prizm 2 DR, had short-circuited and failed. Further tests revealed similar problems with two other Guidant heart devices, the Contak Renewal and Contak Renewal 2.


New England Flu Vaccine Distribution Inadequate, Report Says

This season's supply of flu vaccine in New England is probably sufficient, but it's not being distributed properly, according to a story in the Boston Globe.

The newspaper reports that thousands of unused doses of flu shots have been returned by hospitals and clinics and now have to be quickly redistributed if they are going to be effective. As many as 10,000 doses have been returned to the Massachusetts Department of Public Health for redistribution to doctors and facilities that didn't get enough, the Globe reports. Connecticut's health department sent about 950 doses of flu vaccine last month to a Navajo reservation in New Mexico, which had exhausted its supply, the newspaper reports.

Flu vaccine distribution doesn't flow smoothly, the Globe reports, because it isn't controlled by the U.S. government. An aggregate of private companies and some government agencies handle supply and demand. "We've seen proof that leaving something as essential as the flu vaccine supply in the hands almost entirely of the market forces is grossly inadequate and certainly would lead to a great tragedy if we had a truly severe season," the newspaper quotes Dr. Dora Mills, Maine's top health officer, as saying.


Fired NIH Whistle-Blower Reinstated

Dr. Jonathan Fishbein, a medical safety expert hired in 2003 by the U.S. government's National Institutes of Health and fired less than three years later after raising concerns about at least one AIDS project, has been re-hired.

The Associated Press, which reported on the problems of many government whistle-blowers in 2005, reports that Fishbein was reinstated Dec. 12.

According to the wire service, Fishbein has been assigned as special assistant to the deputy director of NIH's National Institute of Allergy and Infectious Diseases, but that he probably would not resume his previous duties. Among the NIH procedures he reported as wrong or deficient were a number of medical studies, including AIDS testing. Fishbein also filed a formal complaint a division manager, alleging sexual harassment of subordinates.

At first, the NIH said Fishbein was fired for poor performance. But the A.P. reported that he had been recommended for a cash performance just a few weeks before he was fired.

A subsequent internal NIH investigation substantiated many of Fishbein's criticisms, the wire service says.


Poor Nutrition Hurts Early School Achievement, Study Shows

The lack of proper nutrition plays a negative role in academic development in young children, a Cornell University study says, especially in reading skills.

Published in the December issue of the Journal of Nutrition, the research, which examined what scientists call "food insecurity," found that "reading development, in particular, is affected in girls, though the mathematical skills of food-insecure children entering kindergarten also tend to develop significantly more slowly than other children's," said Edward Frongillo, associate professor of nutritional sciences at Cornell. Frongillo and his colleagues define families with food insecurity as "households having limited or uncertain availability of nutritionally adequate or safe foods."

The research also indicates that young girls in the primary grades whose families once were food secure no longer are have difficulty adjusting socially. "We found that kindergarten girls from food-insecure families tend to gain more weight than other girls, which may put them at risk for obesity as adults," Frongillo said.

The Cornell study was conducted over a four year period, using statistics from the U.S. Department of Education of 21,000 children who started kindergarten in 1998.


New Rheumatoid Arthritis Drug Approved, Maker Says

A drug that fights painful rheumatoid arthritis by limiting a signal in a person's immune system has received government approval, its manufacturer has announced.

Bristol-Myers Squibb says the medication with the generic name of abatacept (marketed as Orencia) received U.S. Food and Drug Administration approval Dec. 23.

In clinical trials published in the Sept. 15, 2005 issue of the New England Journal of Medicine abatacept more than doubled the odds that someone with difficult-to-treat rheumatoid arthritis had at least a 20 percent improvement in symptoms.

"Rheumatoid arthritis patients should be optimistic because there's now another option that works well, even where other drugs haven't," Dr. Mark Genovese, an associate professor of medicine and the associate division chief in immunology and rheumatology at Stanford University, told HealthDay. Genovese is the lead author of the study and also a paid consultant for Bristol-Myers Squibb.

More than 2 million Americans have rheumatoid arthritis, according to the Arthritis Foundation. As the disease progresses, loss of movement and function in the affected joints can occur.

Current treatment options include over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs) and other pain relievers; oral steroids; anti-rheumatic drugs, such as methotrexate; and biologic response modifiers, such as etanercept and infliximab, according to the Arthritis Foundation.

According to Genovese, abatacept works by blocking a signal that fully activates the immune system's T-cells. Because the drug modifies the response of the immune system, the risk of infection is potentially increased.


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