Health Highlights: April 25, 2005
FDA Orders More Warning on Heart-Failure Drug IBM Develops Medical Data-Sharing Technology Defibrillator Manufacturer Expands Recall MRI May Help Detect Subconscious Thoughts E-mails Suggest Merck May Have Known of Vioxx's Risks: Report
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Orders More Warning on Heart-Failure Drug
The U.S. Food and Drug Administration is ordering that more information about the risk of death from the heart failure drug nesiritide -- brand name Natrecor -- be added to the package insert for doctors.
The additional information includes findings from seven studies that suggest the drug may increase patients' risk of death within 30 days of treatment. Four of the studies found an increased risk of death compared with other treatments, and three found a decreased risk, the Associated Press reported.
The intravenous drug has been given to more than 600,000 U.S. patients since it was approved in 2001 to combat breathing problems that often accompany heart failure, the AP said.
Last week, a team of physician-researchers heightened its warning about nesiritide. A report issued last month said the drug increased risks for major kidney problems in patients.
And in a study in the April 20 issue of the Journal of the American Medical Association, researchers said the drug was "associated with an increased risk of death in acute heart failure."
A spokesman for the drug's manufacturer -- Scios Inc., a Johnson & Johnson subsidiary, said Monday that the company had agreed to the new labeling, the AP reported.
IBM Develops Medical Data-Sharing Technology
IBM Corp. plans by year's end to test a system for sharing medical data among hospitals, patients, and other approved parties, the Associated Press reported Monday.
President Bush has made the transition from paper to electronic medical records a national priority. That could ultimately trim 10 percent or more from the nation's $1.7 trillion annual health care budget, the wire service said.
While speeding up access to patient records, a large-scale electronic system could also be used to identify emerging disease epidemics and biological attacks, the AP reported.
Initially, IBM said it will "stress test" the system at three company sites in San Jose, Calif., Rochester, Minn., and Haifa, Israel. Security and privacy concerns will be top priorities, a company spokesman said.
Defibrillator Manufacturer Expands Recall
Medtronic Inc. is expanding its February recall of external defibrillators, adding another 396 units to the 1,924 devices identified two months ago, the U.S. Food and Drug Administration announced.
The Lifepack 500 devices may not properly analyze the patient's heart rhythm, even when its electrodes are properly connected, the FDA said in a statement. Failure to properly analyze heart rhythm may inhibit the device's ability to regulate a fluttering heartbeat.
The device is used by firefighters, police officers, and others trained in CPR who are often the first to respond to a cardiac incident, but who lack significant medical training.
Affected devices were produced in 1997. For more information, contact Medtronic at 1-877-873-7630, or visit the company's Web site at www.medtronic-ers.com/500.
MRI May Help Detect Subconscious Thoughts
Scientists may be able to tell what a person is subconsciously thinking by measuring the brain's blood and neurological patterns with an MRI, two new studies published in the journal Nature Neuroscience suggest.
In one experiment, researchers at University College London measured brain activity in the visual cortex, which analyzes information sent by the eyes. By viewing the brain activity of study volunteers, the scientists were able to predict subliminal images flashed on a computer screen better than the volunteers who viewed the images themselves, BBC News Online reported.
A separate study by Japanese researchers found that when people were shown stripes tilted in different directions, there were subtle differences in the pattern of brain activity reflected by the MRI.
The scientists created a computer program to analyze these different brain patterns and found it could predict the direction of the stripes that had been shown to volunteers with "remarkable accuracy," the BBC report said.
E-mails Suggest Merck May Have Known of Vioxx's Risks: Report
Did Merck officials know about the heart risks posed by its now-defunct painkilling drug Vioxx as far back as five years ago?
The New York Times reported Sunday that in 2000, Merck overruled one of its own scientists after he suggested that a 73-year-old female patient in a Vioxx clinical trial had probably died of a heart attack.
In an e-mail exchange concerning Vioxx, a top Merck scientist repeatedly encouraged the researcher to change his views about the death "so that we don't raise concerns." In later reports to the U.S. Food and Drug Administration and in a paper published in 2003, the company labeled the cause of death as "unknown," the newspaper said.
The discussion of the woman's death appears in several previously undisclosed Merck records, including e-mails from Dr. Edward M. Scolnick, Merck's senior scientist from 1985 to 2002, and Dr. Alise S. Reicin, a vice president for clinical research. The messages point to Merck's concerns about data contradicting its view that Vioxx was safe, the Times said.
When Vioxx was pulled from the market last September, Merck officials said they had only recently learned that the drug posed a risk of heart attack and stroke. At least 4,600 people or their survivors are suing the drug company, saying Vioxx -- a member of a class of drugs called cox-2 inhibitors -- caused their heart attacks or strokes. The e-mails and other internal Merck documents, including the report of the woman's death, were given to the Times by an unnamed source working with plaintiffs, the newspaper said.
A lawyer for Merck told the Times that the company had disclosed all information from clinical trials about Vioxx to the FDA. And Scolnick's e-mails "merely reflected his concern that the FDA weigh Vioxx's benefits and risks fairly. The e-mail discussion between the Merck scientists reflected an honest scientific debate over the cause of the woman's death," the newspaper reported, paraphrasing the lawyer.
Earlier this month, another cox-2 drug, Bextra, was withdrawn from the market for the same cardiovascular concerns. A third cox-2, Celebrex, remains available to U.S. consumers, but the FDA has mandated that it carry a strong "black box" warning label indicating the potential for long-term heart risks.