[Congressional Record Volume 151, Number 66 (Wednesday, May 18, 2005)]
[Senate]
[Pages S5440-S5443]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. COCHRAN (for himself, Mr. Kennedy, Mr. Warner, Ms. 
        Cantwell, Ms. Collins, and Mr. Dayton):
  S. 1064. A bill to amend the Public Health Service Act to improve 
stroke prevention, diagnosis, treatment, and rehabilitation; to the 
Committee on Health, Education, Labor, and Pensions.

[[Page S5441]]

  Mr. KENNEDY. Mr. President, the month of May is Stroke Awareness 
Month, and it is a privilege to join Senators Cochran, Warner, 
Cantwell, Collins, and Dayton in introducing the Stroke Treatment and 
Ongoing Prevention Act of 2005. The STOP Stroke Act is a vital step in 
building a national network of effective care to diagnose and quickly 
treat victims of stroke and improve the quality of care for stroke 
patients across America.
  For over 20 years, stroke has been the third leading cause of death 
in our country, affecting about 700,000 Americans a year and killing 
approximately 163,000 a year. Every 45 seconds, another American 
suffers a stroke. Every 3 minutes, another American dies. Few families 
today are untouched by this cruel, debilitating, and often fatal 
disease that strikes indiscriminately, and robs us of our loved ones. 
Even for those who survive, a stroke can have devastating consequences. 
Over half of all survivors are left with a disability.
  Prompt treatment with clot-dissolving drugs within three hours of a 
stroke can dramatically improve these outcomes. Yet, only 2-3 percent 
of all stroke patients are treated with such a drug within those 
crucial first three hours. Few Americans recognize the symptoms of 
stroke, and crucial hours are often lost before a patient receives 
treatment. Emergency room staffs are often not trained to recognize and 
manage the symptoms, which further adds to the delay in treatment. 
Patients at hospitals with primary stroke centers have nearly five 
times greater chance of receiving clot-dissolving drugs.
  Modern medicine is generating new scientific advances that increase 
the chance of survival and at least partial or even full recovery 
following a stroke. Physicians are learning to manage strokes more 
effectively, and they are also learning how to prevent them in the 
first place.
  But science doesn't save lives and protect health by itself. We need 
to do more to bring new discoveries to the patient and new awareness to 
the public. That means educating as many people as possible about the 
warning signs of stroke, so that they know enough to seek medical 
attention. It means training doctors and nurses in the best techniques 
of care. It means finding better ways to treat victims as quickly and 
as effectively as possible--so that they have the best chance of full 
recovery.
  Our bill provides grants to States to implement statewide systems of 
stroke care that will give health professionals the equipment and 
training they need to treat this disorder. It also establishes a 
continuing education program to make sure that medical professionals 
are well trained and well aware of the newest treatments and prevention 
strategies. The initial point of contact between a stroke patient and 
medical care is usually an emergency medical technician. Grants under 
this bill may be used to train these personnel to provide more 
effective care to stroke patients in the crucial first few moments 
after an attack.

  The bill directs the Secretary of Health and Human Services to 
conduct a national media campaign to inform the public about the 
symptoms of stroke, so that more patients can recognize the symptoms 
and receive prompt medical care. The bill also authorizes the Secretary 
of HHS, acting through CDC, to operate the Paul Coverdell National 
Acute Stroke Registry, which will collect data about the care of stroke 
patients and assist in the development of more effective treatments.
  The bill also provides new resources for states to improve the 
standard of care for stroke patients in hospitals, and to increase the 
quality of care in rural hospitals through improvements in 
telemedicine.
  On Monday, the Wall Street Journal published an excellent article on 
the inadequate treatment that stroke patients often encounter when 
ambulances bring them to hospitals with staffs not trained in the early 
treatment of stroke or lacking the needed equipment to intervene early. 
Over twenty years ago, the survival of trauma victims was very much 
dependent on whether the ambulance took them to a hospital with a 
trauma care center, or to a hospital not equipped to treat traumatic 
injury. Congress passed the Trauma Care Systems Planning and 
Development Act of 1990 that revolutionized the treatment for accident 
victims. Now in 2005, it is long past time to see that state of the art 
care is made available to stroke patients as quickly as possible.
  Stroke is a national tragedy that leaves no American community 
unscarred. Fortunately, if the right steps are taken during the brief 
window of time available, effective treatment can make all the 
difference between healthy survival and disability or death. We need to 
do all we can to see that those precious few hours are not wasted. The 
STOP Stroke Act is a significant step in reaching that goal. May is 
Stroke Awareness Month, and I urge Congress to act quickly on this 
legislation, and give stroke victims a far better chance for full 
recovery.
  I ask unanimous consent that the full text of a Wall Street Journal 
article of May 9 on this issue be printed in the Record.
  There being no objection, the article was ordered to be printed in 
the Record, as follows:

              [From the Wall Street Journal, May 9, 2005]

            Stroke Victims Are Often Taken to Wrong Hospital

                         (By Thomas M. Burton)

       Christina Mei suffered a stroke just before noon on Sept. 
     2, 2001. Within eight minutes, an ambulance arrived. Her 
     medical fate may have been sealed by where the ambulance took 
     her.
       Ms. Mei's stroke, caused by a clot blocking blood flow to 
     her brain, occurred while she was driving with her family 
     south of San Francisco. Her car swerved, but she was able to 
     pull over before slumping at the wheel. Paramedics saw the 
     classic signs of a stroke: The 45-year-old driver couldn't 
     speak or move the right side of her body.
       Had Ms. Mei's stroke occurred a few miles to the south, she 
     probably would have been taken to Stanford University Medical 
     Center, one of the world's top stroke hospitals. There, a 
     neurologist almost certainly would have seen her quickly and 
     administered an intravenous drug to dissolve the clot. 
     Stanford was 17 miles away, across a county line.
       But paramedics, following county ambulance rules that 
     stress proximity, took her 13 miles north, to Kaiser 
     Permanente's South San Francisco Medical Center. There, 
     despite her sudden inability to talk or walk and her facial 
     droop, an emergency-room doctor concluded she was suffering 
     from depression and stress. It was six hours before a 
     neurologist saw her, and she never got the intravenous clot-
     dissolving drug.
       In a legal action brought against Kaiser on Ms. Mei's 
     behalf, an arbitrator found that her care had been negligent, 
     and in some aspects ``incomprehensible.'' Today, Ms. Mei 
     can't dress herself and walks unsteadily, says her lawyer, 
     Richard C. Bennett. The fingers on her right hand are curled 
     closed, and she has had to give up her main avocations: 
     calligraphy, ceramics and other types of art. Kaiser declined 
     to comment beyond saying that it settled the case under 
     confidential terms ``based on some concerns raised in the 
     litigation.''
       Stroke is the nation's No. 1 cause of disability and No. 3 
     cause of death, killing 164,000 people a year. But far too 
     many stroke victims, like Ms. Mel, get inadequate care thanks 
     to deficient medical training and outdated ambulance rules 
     that don't send patients to the best stroke hospitals.
       Over the past decade, American medicine has learned how to 
     save stroke patients' lives and keep them out of nursing 
     homes. New techniques offer a better chance of complete 
     recovery by dissolving blood clots and treating even more 
     lethal strokes caused by burst blood vessels in the brain. 
     But few patients receive this kind of treatment because most 
     hospitals lack specialized staff and knowledge, stroke 
     experts say. State and county rules generally require 
     paramedics to take stroke patients to the nearest emergency 
     room, regardless of that hospital's level of expertise with 
     stroke.
       Stroke care is positioned roughly where trauma care was a 
     quarter-century ago. By 1975, surgeons expert at treating 
     victims of car crashes and other major accidents realized 
     that taking severely injured patients to the nearest 
     emergency room could mean death. So the surgeons led a push 
     to make selected regional hospitals into specialized trauma 
     centers and to overhaul ambulance protocols so that 
     paramedics would speed the most severely injured to those 
     centers. Now, in many areas of the U.S., accident victims go 
     quickly to a trauma center, and trauma specialists say this 
     change has saved lives and lessened disability.
       Eighty percent or more of the 700,000 stokes that Americans 
     suffer annually are ``ischemic,'' meaning they are caused by 
     blockage of an artery feeding the brain, usually a blood 
     clot. Most of the rest are ``hemorrhagic'' strokes, resulting 
     from burst blood vessels in or near the brain. Although they 
     have different causes, both result in brain tissue dying 
     by the minute.
       Several factors have combined to prevent improvement in 
     stroke care. In some areas, hospitals have resisted movement 
     toward a system of specialized stroke centers because 
     nondesignated institutions could lose business, according to 
     neurologists who favor the

[[Page S5442]]

     changes. In addition, stroke treatment has lacked an 
     organized lobby to galvanize popular and political interest 
     in the ailment.


                            doctor ignorance

       A big reason for the backwardness of much stroke treatment 
     is that many doctors know little about it. Even emergency 
     physicians and internists likely to see stroke victims tend 
     to receive scant neurology training in their internships and 
     residencies according to stroke specialists.
       ``Surprisingly, you could go through your entire internal 
     medicine rotation without training in neurology, and in 
     emergency medicine it hasn't been emphasized,'' says James C. 
     Grotta, director of the stroke program at the University of 
     Texas Health Science Center at Houston.
       Many hospitals don't have a neurologist ready to deal with 
     emergencies. As a result, strokes aren't treated urgently 
     there, even though short delays increase chance of severe 
     disability or death. Even if doctors do react quickly, recent 
     research has shown that many aren't sure what treatment to 
     provide.
       For example, a survey published in 2000 in the journal 
     Stroke showed that 66 percent of hospitals in North Carolina 
     lacked any protocol for treating stroke. About 82 percent 
     couldn't rapidly identify patients with acute stroke.
       As with other life-threatening conditions, stroke patients 
     are better off going where doctors have had a lot of practice 
     addressing their ailment. A seven-year analysis of surgery in 
     New York state in the 1990s showed that patients with 
     ruptured blood vessels in the brain were more than twice as 
     likely to die--16% versus 7%--in hospitals doing few such 
     operations, compared with those doing them regularly. A 
     national study published last year in the Journal of 
     Neurosurgery showed a similar disparity.
       Another major shortcoming of most stroke treatment, 
     according to many neurologists, is the failure to use the 
     genetically engineered clot-dissolving drug known as tPA. 
     Short for tissue plasminogen activator, tPA, which is made by 
     Genentech Inc., has been shown to be a powerful treatment 
     that can lessen disability for many patients. A study 
     published in 2004 in The Lancet, a prominent medical journal, 
     showed that the chances of returning to normal are about 
     three times greater among patients getting tPA in the first 
     90 minutes after suffering a stroke, even after accounting 
     for tPA's potential side effect of cerebral bleeding that can 
     cause death. But several recent medical-journal articles have 
     found that nationally, only 2% to 3% of strokes caused by 
     clots are treated with tPA, which has no competitor on the 
     market.
       Some authors of studies supporting the use of tPA have had 
     consultant or other financial relationships with Genentech. 
     Skeptics of the drug point to these ties and stress tPA's 
     side-effect danger. But among stroke neurologists, there is a 
     strong consensus that the drug is effective.
       One reason why many patients don't receive tPA is that they 
     arrive at the hospital more than three hours after a stroke, 
     the time period during which intravenous tPA should be given. 
     But many hospitals and doctors don't use tPA at all, even 
     though it has been available in the U.S. since 1996. The 
     dissolving agent's relatively high cost--$2,000 or more per 
     patient--is a barrier. Medicare pays hospital a flat 
     reimbursement of about $6,700 for stroke treatment, 
     regardless of whether tPA is used.


                           airport emergency

       Glender Shelton of Houston had an ischemic stroke caused by 
     a clot at Los Angeles International Airport on Dec. 30, 2003. 
     In full view of other holiday travelers, Ms. Shelton, then 
     66, slumped over, and an ambulance was called. It was 4:45 
     p.m.
       By 5:55 p.m., she arrived at what now is called Centinela 
     Freeman Regional Medical Center, four miles away in Marina 
     del Rey. Hospital records show that doctors thought Ms. 
     Shelton had suffered an ``acute stroke.'' But she didn't get 
     a CT scan, a recommended initial step, until 9 p.m. By then, 
     she was already outside the three-hour window for safely 
     administering intravenous tPA. Records also say she didn't 
     receive the drug ``due to unavailability of neurologist until 
     after the patient had been outside the three-hour time 
     window.''
       Ms. Shelton's daughter, Sandi Shaw, was until recently 
     nurse-manager of the prestigious stroke unit at the 
     University of Texas Health Science Center at Houston. Ms. 
     Shaw says that at her unit, her mother would have had a CT 
     scan within five minutes of arriving, and tPA probably would 
     have been administered 30 or 35 minutes after that.
       Today, according to her daughter, Ms. Shelton often can't 
     come up with words or relatives' names, can't take care of 
     her finances, and can't follow certain basic commands in 
     neurological tests.
       Kent Shoji, an emergency-room doctor at Centinela Freeman 
     who handled Ms. Shelton's case, says, ``She was a possible 
     candidate for tPA,'' but a CT scan was required first. ``The 
     order was put in for a CT scan,'' Dr. Shoji says, ``I can't 
     answer why it took so long.''
       A Centinela Freeman spokeswoman says, ``We did not have 24/
     7 coverage with our CT scan, and we had to call, a technician 
     to come in. That's pretty common with a community hospital.'' 
     The hospital has since been acquired by a larger health 
     system and now does have 24-hour CT capability.


                         `Parochial Interests'

       A hospital-accrediting group has begun designating 
     hospitals as stroke centers, but that is only part of what is 
     needed, stroke experts assert. They say hospitals typically 
     have to come together to create local political momentum to 
     change state or county rules to that ambulances actually take 
     stroke patients to stroke centers, not the nearest ER. New 
     York, Maryland and Massachusetts are moving toward creating 
     stroke-care systems, and Florida recently passed a law 
     creating stroke centers. But in many places, short-term 
     economic interests impede change, some doctors say.
       ``There are still very parochial interests by hospitals and 
     physicians to keep patients locally even if they're not 
     equipped to handle them,'' says neurosurgeon Robert A. 
     Solomon of New York Presbyterian Hospital/Columbia. 
     ``Hospitals don't want to give up patients.''
       The University of California at San Diego runs one of the 
     leading stroke hospitals in the country. It and others in the 
     area that are well prepared to treat stroke patients have 
     sought for a decade to set up a regional system, but there 
     has been little progress, says Patrick D. Lyden, UCSD's chief 
     of neurology, ``Some hospitals are resisting losing stroke 
     business,'' he says. ``We have the same political crap as in 
     most communities. Paramedics still take people to the local 
     ER.''
       Among the opponents of the stroke-center concept during the 
     1990s was Richard Stennes, the ER director at Paradise Valley 
     Hospital south of San Diego. In various public debates, Dr. 
     Stennes recalls, he argued that many apparent stroke patients 
     would be siphoned away from community hospitals even if they 
     didn't turn out to have strokes. Also, he argued that tPA 
     might cause more injury than it prevents. And then there was 
     the economic issue: ``Those hospitals without all the 
     equipment and stroke experts,'' he says, ``would be concerned 
     about all the patients going to a stroke center and taking 
     the patients away from us.'' Dr. Stennes has since retired.
       ``All hospitals and clinicians try to deliver the right 
     care to patients, especially those with urgent medical 
     needs,'' says Nancy E. Foster, vice president for quality of 
     the American Hospital Association, which represents both 
     large and small hospitals. ``Community hospitals may be 
     equally good at delivering stroke care, and it would be 
     important for patients to know how well prepared their local 
     hospital is.''
       Stroke experts aren't proposing that every hospital needs 
     to specialize in stroke care but instead that in every 
     population center there should be at least one that does. In 
     Atlanta, Emory University's neuro-intensive care unit 
     illustrates the special skills that make for top care. Owen 
     B. Samuels, director of the unit, estimates that 20% to 30% 
     of patients it treats received poor initial medical care 
     before arriving at Emory, jeopardizing their futures or even 
     lives. Brain hemorrhages, for example, are commonly 
     misdiagnosed, even in patients who repeatedly showed up at 
     emergency rooms with unusually severe headaches, Dr. Samuels 
     says.
       The Emory unit has 30 staff members, including two neuro-
     critical care doctors and five nurse practitioners. A team is 
     on duty 24 hours a day. The unit handles about two dozen 
     patients most days, keeping the staff busy. On the ward, 
     nearly all patients are unconscious or sedated, so it's 
     eerily silent. Patients generally need to rest their brains 
     as they recover from stroke or surgery.
       After a hemorrhagic stroke, blood pressure in the cranium 
     builds as blood continues to seep out of the ruptured vessel. 
     Pressure can be deadly, cutting off oxygen to the brain. Or 
     escaped blood can cause a ``vasospasm,'' days after the 
     original stroke, in which the brain reacts violently to 
     seeped-out blood. In the worst case, the brain herniates, or 
     squeezes out the base of the skull, causing death. To avoid 
     this, nurses at Emory constantly monitor brain pressure and 
     temperatures. They put in drain lines. They infuse medicines 
     to dehydrate, depressurize and stop bleeding.
       Since Emory launched the neuro-intensive unit seven years 
     ago, 42% of patients with hemorrhagic strokes have become 
     well enough to go home, compared with 27% before. Fewer need 
     rehabilitation--31% versus 40%--and the death rate is down.
       Damica Townsend-Head, 33, gave the Emory team a scare. 
     After surgery last fall for a hemorrhagic stroke, her brain 
     swelling was ``really out of control,'' Dr. Samuels says, 
     raising questions about whether she would survive. The staff 
     put a ``cooling catheter'' into a blood vessel, which allowed 
     the circulation of ice water to bring down the temperature in 
     her blood and brain. They intentionally dehydrated her brain 
     to lower pressure. A month later, she woke up and recovered 
     with minimal disability. She still walks with a cane and 
     tires easily, but her speech is normal and she hopes to 
     return soon to work. ``I consider her what we're in 
     business for,'' Dr. Samuels says.


                            public awareness

       The public's low awareness of stroke symptoms--and the need 
     to respond immediately--can also hinder proper care. Ischemic 
     strokes, those caused by clots or other artery blockage, 
     cause symptoms such as muscle weakness or paralysis on one 
     side, slurred speech, facial droop, severe dizziness, 
     unstable gait and vision loss. People with this kind of 
     stroke are sometimes mistaken for being drunk. In addition to 
     intense head

[[Page S5443]]

     pain, a hemorrhagic stroke often leads to nausea, vomiting or 
     loss of balance or consciousness. Still, many people with 
     some of these symptoms merely go to bed in hopes of improving 
     overnight, doctors say. Instead, they should go immediately 
     to a hospital and demand a CT scan as a first diagnostic 
     step.
       The well-funded American Heart Association, established in 
     1924, has made many people aware of heart attack symptoms and 
     thereby saved many lives. In contrast, the American Stroke 
     Association was started only in 1998 as a subsidiary of the 
     heart association. The stroke association spent $162 million 
     last year out of the heart association's $561 million overall 
     budget.
       Justin Zivin, another University of California at San Diego 
     stroke expert, says the stroke association ``is a terribly 
     ineffective bunch. When it comes to actual public education, 
     I haven't seen anything.''
       The stroke association counters that it is buying 
     television and radio ads promoting awareness, similar to ones 
     produced in 2003 and 2004. The group also sponsors research 
     and education, including an annual international stroke-
     medicine conference.
       It's not just the general public that fails to recognize 
     stroke symptoms. Often, emergency-room doctors and nurses 
     don't either. Gretchen Thiele of suburban Detroit began 
     having horrible headaches last May, for the first time in her 
     life. ``She wasn't one to complain, but she said, `I can't 
     even lift my head off the pillow.' '' recalls her daughter, 
     Erika Mazero. Ms. Thiele, 57, nearly passed out from the pain 
     one night and suffered blurred vision. When the pain recurred 
     in the morning, she went to the emergency room at nearby St. 
     Joseph's Mercy of Macomb Hospital. Ms. Mazero says that 
     during the six hours her mother spent there, she was given a 
     CT scan, but not a spinal tap, which could definitively have 
     shown she had a leaking brain aneurysm, meaning a ballooned 
     and weakened artery in her brain. After the CT, Ms. Thiele 
     was given a muscle relaxant and pain medicine and sent home, 
     her daughter says.
       Two months later, the blood vessel burst. Neurosurgeons at 
     William Beaumont Hospital in Royal Oak, Mich., did emergency 
     surgery, but Ms. Thiele suffered massive bleeding and died. 
     Ali Bydon, one of the neurosurgeons at Beaumont, says a CT 
     scan often is inadequate and that her condition could have 
     been detected earlier with a spinal tap, also called a lumbar 
     puncture. ``Had she had a lumbar puncture and perhaps an 
     operation earlier, it might have saved her life,'' says Dr. 
     Bydon. ``In general, a person who tells you, `I usually don't 
     get headaches, and this is the worst headache of my life,' is 
     something that should alarm you.''
       In addition, he says Ms. Thiele ``absolutely'' was 
     experiencing smaller-scale bleeding in May that foreshadowed 
     a more serious rupture. If doctors identify this kind of 
     bleeding early, he says, chances of death are ``minimal.'' 
     But when a rupture occurs, he says, ``25% of patients 
     never make it to the hospital, 25% die in the hospital and 
     25% are severely disabled.''
       A St. Joseph's hospital spokeswoman says the hospital has 
     ``very aggressive standards for treatment, and we met this 
     standard.'' declining to elaborate.


                            determined nurse

       Paramedics did the right thing after Chuck Toeniskoetter's 
     stroke, but only because of some extraordinary intervention. 
     Mr. Toeniskoetter, then 55, was on a ski trip, Dec. 23, 2000, 
     at Bear Valley, near Los Angeles. He had just finished a run 
     at 3:30 p.m. when, in the snowmobile shop, he began slurring 
     his words and nearly fell over. Kathy Snyder, the nurse in 
     the ski area's first-aid room quickly diagnosed stroke. She 
     called a helicopter and an ambulance.
       Ms. Snyder says she knew the closest hospital with a stroke 
     team was Sutter Roseville Medical Center in Roseville, CA. 
     The helicopter pilot was planning to take Mr. Toeniskoetter 
     to a closer ER, but Ms. Snyder says she stood on the 
     helicopter runners, demanding the patient go to Sutter. The 
     pilot eventually relented. Mr. Toeniskoetter went to Sutter, 
     where he promptly received tPA. Today, he has no disability 
     and is back running a real estate-development business in the 
     San Jose area. ``Trauma patients go to trauma centers, not 
     the nearest hospital,'' he says. ``Stroke victims, too, 
     require a real specialized sort of care.''
       One-third of all strokes are suffered by people under 60, 
     and hemorrhagic strokes in particular often strike young 
     adults and children. Vance Bowers of Orlando, Fla., was 9 
     when he woke up screaming that his eyes hurt, shortly after 1 
     a.m. on Jan. 8, 2001. Malformed blood vessels in his brain 
     were bleeding. He was in a coma by the time an ambulance 
     delivered him at 1:57 a.m. to the nearest emergency room, at 
     Florida Hospital East Orlando.
       Emergency-room doctors soon realized Vance had a 
     hemorrhagic stroke. But neurosurgery isn't performed at that 
     hospital. A sister hospital 14 minutes away by ambulance, 
     Florida Hospital Orlando, did have neurosurgical capability. 
     But in part because of administrative tangles, Vance didn't 
     get to the second hospital until 4:37 a.m., more than two 
     hours after his arrival. Surgery began at 6:18 a.m. ``This 
     delay may have cost this young man the possibility of a 
     functional survival,'' Paul D. Sawin, the neurosurgeon who 
     operated on Vance, said in a letter to the hospitals' joint 
     administration.
       Florida Hospital, an emergency-medicine group and an ER 
     doctor recently agreed to settle a lawsuit filed against them 
     in Orange County, Fla., Circuit Court by the Bowers family. 
     The defendants agreed to pay a total of $800,000, court 
     records show. Monica Reed, senior medical officer of the 
     hospital, says the care Vance received was ``stellar'' and 
     that any delays weren't medically significant. Vance's 
     stroke, not the care he received, caused his injuries, she 
     said.
       Vance, now 13, survived but is mentally handicapped and 
     suffers daily seizures, his mother, Brenda Bowers, says. Once 
     a star baseball player, he goes by wheelchair to a class for 
     disabled children. He speaks very slowly but not in a way 
     that many people can understand. ``He remembers playing 
     baseball with all of his friends,'' his mother says but they 
     rarely come around any more. ``He really misses all that.''
                                 ______