By Steve Sternberg
Special To BioWorld Today
ARLINGTON, Va. — Genentech Inc.’s tissue plasminogen activator (tPA), the first FDA approved drug for acute ischemic stroke, is about to change the way that hospitals will care for many of the nation’s stroke sufferers.
Doctors, nurses, emergency medical technicians and other health professionals — who less than a year ago could only stand by and watch the tragedy of each stroke unfold — have laid out a plan to treat thousands of ischemic stroke sufferers with tPA within an hour of their arrival at the hospital. Rapid treatment promises to spare many the crippling loss of speech and movement that land many people in nursing homes.
“The goal is to literally change the paradigm for the treatment of stroke in this country,“ Zach Hall, director of the National Institute of Neurological Disorders and Stroke (NINDS), in Bethesda, Md., told a recent NINDS-sponsored planning session of more than 50 medical organizations.
About 500,000 people in the U.S. suffer strokes each year. Eighty percent of these people suffer ischemic strokes, which are caused by blood clots. Typically, the clots form elsewhere in the body, break loose and lodge in the proximal cerebral artery of the brain. Blocking this artery cuts off the flow of blood to the brain centers that govern speech and movement.
Speedy treatment is essential because tPA — the only drug proven to dissolve clots and restore blood flow without causing large numbers of fatal hemorrhages — must be given intravenously within three hours of an ischemic stroke if it is to work effectively and without undue side-effects. Currently, too few patients receive the drug either because they fail to recognize the symptoms of a stroke in time to seek treatment or because too few ambulances, doctors and hospitals are geared up to care for them.
To expand access to tPA treatment, the participants drew up what they termed a “chain of recovery,“ beginning with a sweeping publicity campaign to assure the rapid identification of stroke symptoms by those who experience or witness the onset of a stroke; quick access to emergency medical assistance; transport to appropriate medical centers; rapid diagnosis and proper intervention at these centers; and rehabilitation when possible.
“Brain cells are dying every minute after a stroke occurs — time equals brain,“ noted John Marler, the medical officer at NINDS who oversaw the 650-patient multi-center tPA study that demonstrated the drug’s effectiveness.
Once a patient is treated, there’s a one in four chance something dramatic will occur in the next 24 hours, said James Grotta, of the University of Texas, Houston, Medical School. Nearly 20 percent of those treated will retain normal function three months after a stroke. Another six percent will suffer hemorrhages.
About 4,000 patients have been treated with the drug since it was approved, said Paul Laland, a spokesman for Genentech, of South San Francisco. The medical experts at the meeting would like to boost this figure to 40,000 by the end of next year. Each patient receives one dose of tPA, costing $2,200. This is a pittance compared to the cost of caring for just one stroke victim in a nursing home, which can cost $30,000 a year or more.
Participants at the meeting said the new guidelines would be released in the near future by the 50 participating organizations. The guidelines set minimal standards designed to enable every hospital in the U.S. to provide emergency stroke treatment. They also establish standards for comprehensive stroke treatment centers.
“There is no longer an excuse for any hospital to say, we don’t know how to provide minimal, high-quality stroke care’,“ said Anthony Furlan, medical director of the Cerebrovascular Center of the Cleveland Clinic Foundation in Ohio. Currently, just 10 to 15 percent of hospitals nationwide have adopted rapid stroke-treatment protocols.
Once the guidelines are distributed, many hospitals are likely to adopt them for two reasons: to provide quality care to patients and to avoid malpractice lawsuits, based on allegations that the hospitals’ standard of care fell below accepted standards.
Meeting the minimal guidelines would require that hospitals have a CT Scanner and a stroke “code“ team available around the clock.
Many hospitals already have stocks of tPA — which is sold under the name Activase — on hand to treat heart-attack sufferers. Under the new guidelines, they would also have to obtain supplies containing the lower dosage recommended for people with strokes. This formulation, which is administered more quickly than the heart-attack version of the drug, is designed to minimize the possibility of potentially fatal hemorrhages. It is sold at the same price as the higher-dose formulation, said Genentech’s Laland.