Health Highlights: April 27, 2010
Drug Giant AstraZeneca to Pay $520 Million Over Claims of Illegal Marketing of Antipsychotic FDA Announces Medical Device Committee Changes Michaels May Recover, Neurosurgeons Say Cardiac Science External Defibrillators May Malfunction: FDA Food Companies Will Reduce Salt In Products
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Drug Giant AstraZeneca to Pay $520 Million Over Claims of Illegal Marketing of Antipsychotic
To settle government claims that it marketed the antipsychotic Seroquel to pediatric and elderly patients illegally, AstraZeneca is to pay about $520 million in fines, the Associated Press reported Tuesday.
Seroquel is approved to treat schizophrenia in patients older than 13, and bipolar disorder in patients older than 10, according to the AP.
However, the U.S. Drug and Food Administration charged that the pharmaceutical giant marketed Seroquel for a variety of illnesses it had never been tested for, including aggression, Alzheimer's, anger management, anxiety, attention-deficit hyperactivity disorder, dementia, depression, mood disorder, post-traumatic stress disorder, and sleeplessness. It was given to the elderly, children, veterans and inmates, allegedly through kickbacks to doctors, according to the wire service.
The federal government will get $302 million, and states will receive up to $218 million, the AP reported. Other lawsuits have been filed over Seroquel, one of AstraZeneca's top sellers.
"These were not victimless crimes -- illegal acts by pharmaceutical companies and false claims against Medicare and Medicaid can put the public health at risk, corrupt medical decisions by health care providers, and take billions of dollars directly out of taxpayers' pockets," Attorney General Eric Holder said during a Tuesday news conference announcing the settlement.
Although the company has denied the charges, AstraZeneca general counsel Glenn Engelmann said in a statement that resolving the case was "in the best interest" of the company.
FDA Announces Medical Device Committee Changes
Changes in how medical device advisory committees review and discuss data and information at public meetings will take effect May 1, says the U.S. Food and Drug Administration.
The goal is to improve discussion and flow of information during meetings of the committees, which make recommendations about whether the FDA should approve new medical devices.
"These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a news release.
Voting procedures are a major area where changes are being made, the agency said. The committees will now vote on the safety and effectiveness of a device and on its risks versus benefits.
"By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes," Shuren said. "The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them."
Michaels May Recover, Neurosurgeons Say
The prognosis for reality TV and rock star Bret Michaels remains uncertain, but some doctors are optimistic about his chances for recovery.
Michaels, 47, was hospitalized last week after he suffered a massive subarachnoid hemorrhage, or bleeding at the base of the brain stem. On Sunday, statements posted on the star's Web site said the frontman of the glam-metal band Poison was in critical condition in the intensive care unit at an undisclosed hospital, ABC News reported.
There were reports that Michaels was able to talk, but that his speech was slurred. The fact that he's conscious offers more hope for recovery than if he were comatose, according to experts.
"Based on how he is being described now, I would like to remain optimistic that he will survive this potentially devastating diagnosis," Dr. Wendy Wright, an assistant professor of neurology and neurosurgery at Emory University Hospital in Atlanta, told ABC News.
"The fact that he's made it to a hospital and is apparently in some sort of reasonable condition ... that's a good sign," said Dr. Arno Fried, chairman of neurosurgery at Hackensack University Medical Center in Hackensack, N.J. "I would describe [Michaels' condition] as guarded. If the bleed has not caused too much damage, the possibility of recovery is quite good."
Cardiac Science External Defibrillators May Malfunction: FDA
Some models of external defibrillators made by Cardiac Science might malfunction and fail to deliver life-saving shocks to restore normal heart rhythm to people in sudden cardiac arrest, says the U.S. Food and Drug Administration.
The warning applies to about 280,000 automatic and semi-automatic defibrillators used worldwide in public locations, health care facilities and homes, United Press International reported.
"In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography analysis, failure to recognize electrode pads and interference or background noise that makes the device unable to accurately analyze heart rhythm," the FDA said.
The 14 models with potential problems are:
- Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E.
- CardioVive models 92531, 92532 and 92533.
- Nihon Kohden models 9200G and 9231.
- GE Responder models 2019198 and 2023440.
The FDA said institutions and other consumers with these models should obtain other external defibrillators and repair or replace the affected defibrillators, UPI reported.
Food Companies Will Reduce Salt In Products
As part of the national effort to lower U.S. sodium consumption by 20 percent, 16 food companies announced Monday that they plan to reduce the amount of salt in dozens of products such as bacon and flavored rice.
The companies said they'll commit to the voluntary National Salt Reduction Initiative, a public-private partnership initiated by New York City, the Associated Press reported.
Among the planned reductions:
- Mars Foods will reduce the amount of sodium in Uncle Ben's flavored rice products by 25 percent over five years.
- Heinz will cut sodium in ketchup by 15 percent staring May 1.
- The Subway sandwich chain is working with food suppliers to reduce sodium in all of its menu items.
Too much sodium in the diet can lead to high blood pressure, cardiovascular disease, stroke and other health problems.
"If we reduced our sodium intake to recommended levels, we would prevent 44,000 to 92,000 deaths per year in the United States and save $10 billion to $24 billion in health care costs per year," said New York City Health Commissioner Dr. Thomas Farley, the AP reported.