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Health Highlights: May 8, 2005

FDA Warns Pfizer On Zoloft Magazine AdImplantable Defibrillator Use Recommended for Certain Recently Diagnosed Heart Patients States Pushing for Employers to Assume More Health Care Costs World Health Officials Unveil Drug Monitoring System

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

FDA Warns Pfizer About Zoloft Magazine Ad

A magazine advertisement for the antidepressant Zoloft omitted important information about the possibility of suicide, The Food and Drug Administration said in a May 6 letter to the drug's manufacturer, Pfizer Inc.

The letter, along with a warning to health care professionals about possible suicide risk with Zoloft, was posted on the FDA's Web site Friday. The Wall Street Journal reports that the ad the government agency mentioned was one that ran in the New York Times Sunday Magazine Oct. 24, 2004. The FDA letter reminded Pfizer it had alerted the pharmaceutical company in May 2004 that the information had to be included the labeling material on all print advertising.

"This ad is concerning from a public health perspective because it fails to include a serious risk associated with the drug," the FDA Consumer Promotion Analyst Kay A. Chitale wrote. She told Pfizer to immediately stop using that particular ad or similar ones. "Specifically, the main page of the ad fails to communicate any information pertaining to the risk of clinical worsening and suicidality in patients who are on Zoloft therapy," Chitale concluded.

The Wall Street Journal said that the Pfizer had agreed to change the Zoloft label last July. The pharmaceutical company didn't return a phone call from the newspaper asking for comment, the Journal said.

Whether deliberately or by coincidence, the FDA issued the alert about Zoloft and the risk of pediatric suicide to the public and health officials on May 5.


Implantable Defibrillator Use Recommended for Certain Recently Diagnosed Heart Patients

A patient who has just been diagnosed with cardiomyopathy, a disease that affects the heart muscle's ability to pump, would benefit from an implantable defibrillator, a study has concluded.

The research was presented over the weekend to members of the Heart Rhythm Society's Annual Scientific Sessions in New Orleans and was based on previous studies showing that implantable cardiac defibrillators (ICDs) were effective in controlling cardiac myopathy.

But the U.S. government's Center for Medicare and Medicaid Services had established payment guidelines based on cardiac myopathy diagnoses of about nine months, the lead researcher said in a news release.

Dr. Alan Kadish, associate chief of Cardiology and associate director of the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital, said the study was designed to see if those diagnosed with cardiac myopathy would benefit from an earlier ICD implant.

The government "... established guidelines that limited ICD use in patients with recently diagnosed cardiomyopathy," Kadish said. "However, our study found that patients who have a recent cardiomyopathy diagnosis appear to get just as good a survival benefit from ICD implantation as those with a remote diagnosis. Therefore, these findings could help expand the number of patients who benefit from this life-saving therapy."


States Pushing for Employers to Assume More Health Care Costs

Government figures show that an alarming number of U.S. residents have jobs but no health insurance, and some state governments are considering requiring employers to provide more health care coverage.

The Robert Wood Johnson Foundation recently reported that more than 20 million working adults in the United States don't have health insurance. And according to a story in the New York Times, more than 45 million Americans -- employed and unemployed -- have no health insurance at all.

This has placed a heavy financial burden on individual states, the Times reports, causing state governments to consider shifting the burden of providing the minimal health coverage for the uninsured to employers.

The names of some of these companies the newspaper cited is surprising, including Dunkin' Donuts, Wal-Mart and Stop & Shop, a large Northeast supermarket chain. These companies supply so little in health benefits, the state claims, that many employees are on Medicaid or some other form of state assistance for those below the poverty level.

Massachusetts has already ordered these and other employers to pick up the cost of additional health coverage. Wal-Mart is challenging the order, the Times says, while Dunkin' Donuts claims individual franchises are responsible for health insurance decisions for their employees.

At least two dozen states are now considering some sort of law requiring employers to pick up health care costs, which until now was not required anywhere in the United States. Maryland may be a key state. "The focus of the debate is whether there should be an employer mandate," the Times quotes Ellen Valentino, Maryland director for the National Federation of Independent Business, as saying. Her group of small Maryland businesses is opposing the legislation.


World Health Officials Unveil Drug Monitoring System

The World Health Organization (WHO) has unveiled the world's first Internet-based system to track fake drugs, BBC News Online reported Friday.

As much as 10 percent of the global prescription drug market is comprised of phony concoctions, amounting to $35 billion a year, WHO officials said at a news conference in the Philippines.

The problem is most critical in developing nations, where up to 25 percent of medicines are fake or substandard, the BBC quoted WHO officials as saying. The Rapid Alert System initially will track counterfeit drugs in Asia, and theoretically could be expanded globally, the organization said.


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