[Congressional Record (Bound Edition), Volume 146 (2000), Part 17]
[Extensions of Remarks]
[Pages 24687-24689]
[From the U.S. Government Publishing Office, www.gpo.gov]



                       STROKE THERAPY'S NEW PUSH

                                 ______
                                 

                          HON. DAVID E. PRICE

                           of north carolina

                    in the house of representatives

                       Tuesday, October 24, 2000

  Mr. PRICE of North Carolina. Mr. Speaker, a recent article in the 
Washington Post reminds us of the urgent attention stroke deserves as 
the third leading cause of death in this country.
  Stroke affects the most delicate and vital organ of the body, the 
brain. The National Stroke Association uses the term ``brain attack'' 
to characterize this medical condition and describe the urgent need for 
prompt medical attention. A stroke occurs when blood flow to the brain 
is interrupted either by a clogged artery or a blood vessel rupture.
  Stroke touches the lives of four out of every five American families. 
It touched the Congress this year with the tragic death of our friend 
and colleague, Senator Paul Coverdell. Each year 750,000 Americans will 
suffer a stroke and 160,000 of them will die. African Americans and 
Latinos are at an even greater risk of stroke. Stroke is also a leading 
cause of adult disability, leaving a majority of survivors with 
disabilities ranging from moderate to severe. The statistics are 
staggering, but fortunately, many strokes can be prevented.
  There are important resources available for stroke prevention, 
treatment and rehabilitation. The National Stroke Association has a 
wealth of information available on its web site at www.stroke.org, or 
by calling 1-800-STROKES. Clearly, stroke is an issue that deserves 
debate, discussion and our immediate attention as a major public health 
issue. I submit this article to my colleagues and look forward to 
discussing approaches we might take to reduce the terrible toll from 
stroke.

   [From The Washington Post, Sept. 24, 2000, Sunday, Final Edition]

  Stroke Therapy's New Push; Aggressive Doctors Go Deep Into the Brain

                            (By Susan Okie)

       Like a wisp of cloud that's really the edge of a hurricane, 
     the first sign of what was

[[Page 24688]]

     about to happen to Garline Perry seemed a small thing.
       One morning last month, Perry complained to his wife that 
     he couldn't keep his balance. When he tried to walk, she 
     said, he kept ``listing to the right.''
       Susana Perry took her husband, 57, to the emergency room at 
     Inova Fair Oaks Hospital. Minutes after they arrived, the 
     storm hit.
       ``He yelled, `I can't hear you! I can't see you!' . . . He 
     fell to the floor and starting convulsing,'' recalled Susana 
     Perry. A two-inch clot had blocked a major artery at the back 
     of Perry's brain, producing a catastrophic stroke.
       Unable to move, talk, breathe or even blink, the Fairfax 
     man was placed on a respirator and flown by helicopter to 
     Inova Fairfax Hospital, where radiologist John J. ``Buddy'' 
     Connors embarked on a rescue mission that few doctors would 
     dare attempt. He snaked a long, fine tube through an artery 
     to reach the plug of congealed blood inside Perry's brain and 
     began to drip in a clot-busting drug, hoping to reopen the 
     blocked vessel.
       Along with perhaps 300 other doctors in the United States, 
     Connors works on the uncharted borders of stroke therapy, 
     putting novel devices and powerful drugs deep into an organ 
     where a mishap can mean death, coma or paralysis. Such 
     maneuvers signal a newly activist approach to a disorder that 
     doctors once met with resignation. Strokes, the third-leading 
     cause of death in the United States, are now viewed as 
     emergencies in which rapid and aggressive treatment may save 
     lives and minimize disability.
       Although the treatment administered by specialists such as 
     Connors has produced dramatic results for some patients, it 
     remains largely untested except in small pilot studies. The 
     situation underscores the challenge researchers face in 
     developing a new treatment, especially a complex one that 
     combines drugs, devices and technical skill. Often, such 
     therapies are refined and tested one patient at a time, 
     evolving and prolifering for years before anyone is certain 
     how well they work.
       ``The fact that [a new treatment] seems logical and does 
     what it should doesn't necessarily mean that it's going to 
     benefit the patient,'' said John R. Marler, associate 
     director for clinical trials at the National Institute of 
     Neurological Disorders and Stroke.
       Doctors such as Connors, faced daily with desperate cases, 
     contend that they are advancing medical knowledge as best 
     they can. ``We have to do this,'' Connors said. ``We know we 
     can help patients. . . . There is no regulatory process for 
     this kind of thing.''


                             Damage Control

       Some 600,000 Americans suffer strokes each year. The 
     problem occurs when a blood vessel in the brain becomes 
     blocked by a clot or hemorrhage, causing nerve cells supplied 
     by the vessel to die. Until recently, there was no way to 
     mitigate the damage, only physical therapy and the hope that 
     the brain would partially recover in time.
       That changed in 1996, when the Food and Drug Administration 
     approved the clot-dissolving drug tPA as the first effective 
     treatment. But only about 2 percent of U.S. stroke victims 
     receive tPA. a major reason is time: The intravenous therapy 
     only helps if it is started within three hours of the first 
     symptoms, and few people with an incipient stroke make it to 
     the emergency room and through the required battery of 
     checkups and tests before that deadline has passed.
       The approach Connors uses appears to be effective if 
     started within six hours after symptoms begin. Specialists in 
     his field also believe it may produce better outcomes by 
     delivering clot-dissolving drugs directly into an artery of 
     the brain instead of through an arm vein, the only mode of 
     administration approved by the FDA.
       When tPA is given intravenously, Connors said, ``they give 
     you a massive amount . . . just so that a teeny bit of it 
     might get to a small clot in your brain.'' It's like pouring 
     Drano into a house's main water intake pipe, hoping that some 
     will reach a blocked sink. In contrast, Connors said, he uses 
     a different clot-dissolving drug at about one-fiftieth the 
     usual intravenous dose and puts it as close as possible to 
     the blockage.
       The effectiveness of intra-arterial treatment varies, 
     depending on how soon it is started and on the size and 
     location of the clot. Only two studies, funded by Abbott 
     Laboratories, maker of a clot-dissolving drug called 
     prourokinase, have evaluated such treatment by comparing it 
     with a placebo. In the larger study, involving 180 patients, 
     40 percent of those who received the therapy recovered enough 
     to live independently, compared with 25 percent of patients 
     given a placebo. The degree of benefit was similar to that 
     seen with intravenous tPA, but the rate of brain hemorrhages 
     was higher--about 10 percent among recipients of intra-
     arterial prourokinase, compared with 6 percent among patients 
     in the tPA study.
       Although the findings suggested that the treatment could be 
     beneficial, the FDA asked the manufacturer to conduct another 
     study to obtain more data about the therapy's safety and 
     effectiveness. Abbott has not decided whether to do so.
       Genentech Inc., which makes tPA, also has not decided 
     whether to study intra-arterial treatment, a spokesman said.
       Connors believes that companies do not want to fund 
     additional trials because they doubt they will recoup 
     research costs. ``Genentech, Abbott and other companies have 
     done the math. . . . The doses that we use for [intra-
     arterial] therapy are so small that it would take 500 years 
     for them to make that money back at the rate that we are 
     using the drugs now,'' he said.
       Tareta Lewis, an Abbott spokeswoman, said cost is not the 
     only consideration. ``There are many things that go into 
     making the decision,'' she said.
       Lacking such studies, Connors and other specialists say 
     they don't know the exact benefits and risks of what they are 
     doing.
       ``We get the patients who don't meet the three-hour time 
     window'' for intravenous tPA, said Richard Latchaw, chief of 
     neuroradiology at the University of Pittsburgh. ``Using a 
     compassionate view, we will go ahead and give intra-arterial 
     tPA in a dosage that we personally think is efficacious. Do 
     we know exactly what that dosage should be? No.''
       The therapy has never been directly compared with 
     intravenous tPA. The National Institute of Neurological 
     Disorders and Stroke plans to fund a study at the University 
     of Cincinnati Medical Center in which researchers will give 
     80 patients with major strokes a combination of intravenous 
     and intra-arterial treatment. They intend to compare the 
     outcomes to existing data on intravenous tPA.
       ``Itra-arterial therapy does more than put the drug next to 
     the clot,'' said Marler. ``They're passing the catheter into 
     the clot, trying to break [it] up. . . . There are definitely 
     patients it will help, but does it balance out'' against the 
     increased risk of bleeding?
       In the meantime, Connors said, ``hundreds of patients are 
     being treated right now, all over the United States.'' He has 
     organized a training course for doctors to be held in 
     Washington next month and is setting up a registry to collect 
     data on patient outcomes.
       ``This is a new field and we don't know everything we need 
     to know,'' Connors said. ``You're playing statistics. The 
     whole thing is statistics and odds.''


                          Difficult Decisions

       The odds in Perry's case looked to be long. His clot was in 
     the basilar artery, dreaded location for a stroke because it 
     nourishes areas of the brain that control life-support 
     functions such as breathing. Without treatment, he would 
     certainly die. With it, Connors thought he might recover and 
     regain considerable function.
       But there was a third possibility. Perry might end up in a 
     nightmarish state that neurologists call ``locked in''; awake 
     and aware, but permanently unable to speak, move or 
     communicate.
       If that were the outcome, Connors told Susana Perry that 
     afternoon, ``if it was me, I wouldn't want to make it.''
       He offered to stop treatment if she thought it best.
       When Connors posed that question, he and his team had 
     already been working on Perry for an hour at Inova Fairfax 
     Hospital. Perry lay on a table in an operating room equipped 
     with X-ray machines that took magnified pictures of blood 
     flowing through the vessels of his brain.
       While an anesthesiologist monitored Perry's vital 
     functions, surgically gowned nurses and technicians rushed to 
     fetch drugs and equipment.
       Connors and another doctor, Firas Al-Ali, had threaded a 
     long, slippery tube called a catheter, thinner than a strand 
     of angel hair pasta, through a larger tube in Perry's groin, 
     guiding it along major arteries of his abdomen, chest and 
     neck until the tip rested against the clot inside his skull.
       Through the catheter, they squirted dye to illuminate the 
     blocked vessel on X-rays and dribbled in medicines that they 
     hoped would tease apart the clump of protein and blood cells.
       Most clots that Connors attacks in this way are the size of 
     a grain of rice. Perry's was the size of his little finger.
       Connors asked Susana Perry for permission to ``go for 
     cleaning everything up'' to maximize her husband's chances of 
     recovery--even though doing so would heighten the risk that 
     the drugs might cause bleeding in his brain.
       ``His outlook was 99 percent death,'' Connors said. ``The 
     options were so bad. It's one thing to have a stroke where 
     you can't move your arm but you're mostly still you. It's 
     another thing to have a stroke where you're paralyzed from 
     the eyes down. . . . There's no right or wrong decision on 
     this. It's something where you have to think, `What if this 
     was me?' and get the family involved.''
       Susana Perry told Connors to go for broke. ``I said, `I'm 
     not ready to get rid of this guy,' '' she recalled.
       Connors treated Perry for eight more hours. At last, he 
     removed the catheter and stitched up the small wound in 
     Perry's groin. He estimated that he had dissolved about 95 
     percent of the clot. Now, it was a matter of waiting to see 
     whether the treatment had worked.
       At 1 a.m. the next day, a nurse woke Susana Perry, who was 
     asleep in a room near the intensive care unit. ``He's 
     responding,'' the nurse said. ``He's nodding `yes' or `no' to 
     simple questions.''

[[Page 24689]]

       Perry was still on a respirator and his left side was 
     paralyzed, but the pace of his recovery over the next few 
     days astonished his doctors. Three days after his stroke, he 
     signaled to his son that he wanted something. A nurse handed 
     him a pad and pencil. He wrote, ``Beer.''
       Two days later, doctors disconnected the respirator and 
     Perry was able to breathe on his own. A week after the 
     stroke, he had regained some movement in his left leg and was 
     eating and cracking jokes about the hospital food. ``There's 
     so much I'm learning from the beginning,'' he said, speaking 
     slowly. ``You take so much for granted.''
       ``His level of recovery is--what can I say?--miraculous,'' 
     said David Grass, Perry's neurologist. ``This would have been 
     fatal, absolutely no doubt. . . . He has a left-sided 
     weakness that is improving. He has normal mental function. He 
     has some mild difficulty seeing to his right, but that's 
     improving. He's had no problems with speech. . . . He's going 
     to need several months of rehabilitation, but I'm optimistic 
     that he may eventually be able to return to work. ''

     

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