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By Steve Sternberg, USA TODAY
Ten years ago, the stroke drug Activase was hailed as a medical breakthrough — the first treatment able to melt clots away and save the brain. It is still the only frontline treatment approved for stroke in the USA.
Yet for many patients, Activase may as well not exist. Only a fraction of those who could benefit from the drug, made by the biotech firm Genentech, get it.
"Here we have a disease that kills 150,000 to 160,000 people every year, that occurs every 45 seconds, and (Activase is) only used in 3% to 4% of patients," says Mark Alberts of Northwestern University in Chicago. "It's a national embarrassment."
Now, after years of hand-wringing over neglect of stroke, experts say, things are starting to change.
For instance, evidence suggests that sales of Activase, the trade name for tissue plasminogen activator, or tPA, are rising. A study of nearly 17,000 patients in last February's Neurology found Activase use more than doubled in seven of 11 stroke centers that were well organized and followed treatment guidelines. Use at one center soared from 1.5% of patients to 10.5%, say lead researcher Vanja Douglas of the University of California-San Francisco and her colleagues.
Another factor that may increase Activase use, experts say, was an August ruling by the U.S. Center for Medicare and Medicaid Services to pay hospitals $11,578, when they treat stroke patients with Activase, nearly double the $4,000 to $6,000 they were paid previously for all stroke patients.
And new treatments are in the pipeline. They include a clotting factor to stem the kind of brain hemorrhage that occurred in Israeli Prime Minister Ariel Sharon when he suffered a major stroke Jan. 4. Researchers also are exploring ways to protect stroke-threatened brain tissue — including lowering body temperature to slow metabolism and reduce inflammation.
"We're making progress," says University of Cincinnati neurologist Joseph Broderick, "but we have a long way to go."
Strokes result from a disruption in the brain's blood supply. Roughly 85% occur when a clot dams up an artery. The rest result from a leaky blood vessel that robs the brain of blood and boosts internal pressure, which can crush the brain within the skull.
The clot-buster Activase was designed to treat strokes caused by blocked arteries. But it works only if it is given within three hours, before brain tissue begins to die. At the stroke center in Northwestern Memorial Hospital, Alberts says, fewer than 40 of 600 patients each year get Activase because they arrive after the three-hour "window" closes.
The clock begins ticking at the last moment a person was "known to be normal" by someone else. Before doctors order treatment, they request a brain scan to determine the stroke's cause. Giving Activase to a bleeding patient can cause a fatal hemorrhage. Treatment also may cause hemorrhages in 4% to 6% of patients with strokes caused by clots, but studies show the benefit is worth the risk.
When the drug is given correctly, Alberts says, "it makes stroke patients normal or nearly normal." Still, he says, "we desperately need medicines that are safe and effective and work beyond the three-hour window."
The stroke pipeline includes:
•Desmoteplase. It is made from a protein extracted from vampire bat saliva, reportedly the most potent anti-clotting substance known. A major trial is underway to test whether the Pfizer drug is safe and can be used after three hours.
•Factor VII. Novo Nordisk's biotech protein was made for hemophilia patients whose bodies reject other clotting agents. "If it works, it would be the first treatment for hemorrhagic stroke," says John Marler of the National Institutes of Health.
•Cerovive. The AstraZeneca anti-inflammatory drug aims to prevent "collateral damage" from the biochemical chain reaction that kills nerve cells after a stroke. In early tests, Cerovive appears to offer a "modest" benefit, says James Grotta of the University of Texas Health Sciences Center in Houston.
In other experiments, researchers are using ultrasound with Activase to increase and extend the drug's effectiveness at dissolving clots. They're exploring whether magnetic resonance images (MRIs) can pinpoint patients who will benefit from treatment after three hours have passed. And they're testing whether the Merci Retrieval System, a government-approved corkscrew-like device that removes blood clots from the brain, can limit brain damage when used after the three-hour window has closed. At the same time, the federal government, medical groups, some hospitals and doctors are pushing for systemwide changes in stroke treatment, Grotta says.
One solution is to establish networks of specialized stroke centers and make sure paramedics take patients to the hospitals where they'll get the best care. More than 180 hospitals nationwide have won certification as primary stroke centers from the Joint Commission on Accreditation of health care Organizations.
The American Heart Association, its subsidiary the American Stroke Association, and the National Stroke Association are trying to educate people to call 911 the minute they suffer symptoms. Warning signs include numbness or weakness, especially on one side; difficulty speaking or understanding speech; trouble seeing with one or both eyes; difficulty walking; dizziness; and severe headache with no known cause.
Despite the publicity, people often ignore warning signs and get to the hospital too late.
"There are all kinds of billboards out there — 'Time is brain loss, call a paramedic' — but it doesn't make a difference," Grotta says. "Behavior is hard to change."
To obtain a list of certified stroke centers Visit the Joint Commission on Accreditation of Healthcare Organizations' website and scroll down to primary stroke centers: http://www.jcaho.org/dscc/dsc/certif...ns-disease.htm.
Ten years ago, the stroke drug Activase was hailed as a medical breakthrough — the first treatment able to melt clots away and save the brain. It is still the only frontline treatment approved for stroke in the USA.
Yet for many patients, Activase may as well not exist. Only a fraction of those who could benefit from the drug, made by the biotech firm Genentech, get it.
"Here we have a disease that kills 150,000 to 160,000 people every year, that occurs every 45 seconds, and (Activase is) only used in 3% to 4% of patients," says Mark Alberts of Northwestern University in Chicago. "It's a national embarrassment."
Now, after years of hand-wringing over neglect of stroke, experts say, things are starting to change.
For instance, evidence suggests that sales of Activase, the trade name for tissue plasminogen activator, or tPA, are rising. A study of nearly 17,000 patients in last February's Neurology found Activase use more than doubled in seven of 11 stroke centers that were well organized and followed treatment guidelines. Use at one center soared from 1.5% of patients to 10.5%, say lead researcher Vanja Douglas of the University of California-San Francisco and her colleagues.
Another factor that may increase Activase use, experts say, was an August ruling by the U.S. Center for Medicare and Medicaid Services to pay hospitals $11,578, when they treat stroke patients with Activase, nearly double the $4,000 to $6,000 they were paid previously for all stroke patients.
And new treatments are in the pipeline. They include a clotting factor to stem the kind of brain hemorrhage that occurred in Israeli Prime Minister Ariel Sharon when he suffered a major stroke Jan. 4. Researchers also are exploring ways to protect stroke-threatened brain tissue — including lowering body temperature to slow metabolism and reduce inflammation.
"We're making progress," says University of Cincinnati neurologist Joseph Broderick, "but we have a long way to go."
Strokes result from a disruption in the brain's blood supply. Roughly 85% occur when a clot dams up an artery. The rest result from a leaky blood vessel that robs the brain of blood and boosts internal pressure, which can crush the brain within the skull.
The clot-buster Activase was designed to treat strokes caused by blocked arteries. But it works only if it is given within three hours, before brain tissue begins to die. At the stroke center in Northwestern Memorial Hospital, Alberts says, fewer than 40 of 600 patients each year get Activase because they arrive after the three-hour "window" closes.
The clock begins ticking at the last moment a person was "known to be normal" by someone else. Before doctors order treatment, they request a brain scan to determine the stroke's cause. Giving Activase to a bleeding patient can cause a fatal hemorrhage. Treatment also may cause hemorrhages in 4% to 6% of patients with strokes caused by clots, but studies show the benefit is worth the risk.
When the drug is given correctly, Alberts says, "it makes stroke patients normal or nearly normal." Still, he says, "we desperately need medicines that are safe and effective and work beyond the three-hour window."
The stroke pipeline includes:
•Desmoteplase. It is made from a protein extracted from vampire bat saliva, reportedly the most potent anti-clotting substance known. A major trial is underway to test whether the Pfizer drug is safe and can be used after three hours.
•Factor VII. Novo Nordisk's biotech protein was made for hemophilia patients whose bodies reject other clotting agents. "If it works, it would be the first treatment for hemorrhagic stroke," says John Marler of the National Institutes of Health.
•Cerovive. The AstraZeneca anti-inflammatory drug aims to prevent "collateral damage" from the biochemical chain reaction that kills nerve cells after a stroke. In early tests, Cerovive appears to offer a "modest" benefit, says James Grotta of the University of Texas Health Sciences Center in Houston.
In other experiments, researchers are using ultrasound with Activase to increase and extend the drug's effectiveness at dissolving clots. They're exploring whether magnetic resonance images (MRIs) can pinpoint patients who will benefit from treatment after three hours have passed. And they're testing whether the Merci Retrieval System, a government-approved corkscrew-like device that removes blood clots from the brain, can limit brain damage when used after the three-hour window has closed. At the same time, the federal government, medical groups, some hospitals and doctors are pushing for systemwide changes in stroke treatment, Grotta says.
One solution is to establish networks of specialized stroke centers and make sure paramedics take patients to the hospitals where they'll get the best care. More than 180 hospitals nationwide have won certification as primary stroke centers from the Joint Commission on Accreditation of health care Organizations.
The American Heart Association, its subsidiary the American Stroke Association, and the National Stroke Association are trying to educate people to call 911 the minute they suffer symptoms. Warning signs include numbness or weakness, especially on one side; difficulty speaking or understanding speech; trouble seeing with one or both eyes; difficulty walking; dizziness; and severe headache with no known cause.
Despite the publicity, people often ignore warning signs and get to the hospital too late.
"There are all kinds of billboards out there — 'Time is brain loss, call a paramedic' — but it doesn't make a difference," Grotta says. "Behavior is hard to change."
To obtain a list of certified stroke centers Visit the Joint Commission on Accreditation of Healthcare Organizations' website and scroll down to primary stroke centers: http://www.jcaho.org/dscc/dsc/certif...ns-disease.htm.
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