Proposed US stroke centres under fire for planned use of alteplase

BMJ 2003; 327 doi: (Published 31 July 2003) Cite this as: BMJ 2003;327:247
  1. Jeanne Lenzer
  1. New York

    Federal legislation to designate US hospitals as “stroke centres” only if they can administer alteplase within three hours from onset of symptoms is causing concern among doctors who question the drug's efficacy.

    The opponents also say the plans are an attempt to short-circuit a scientific debate that should be settled by doctors, not politicians.

    The Stroke Treatment and Ongoing Prevention Act, which is due to be considered by Congress, would authorise $165m (£101m; €144m) in 2003 and about $125m a year through to 2008 to establish the specialist stroke centres.

    The American Heart Association has launched a campaign telling the public to call the emergency number if they have symptoms of a stroke and another directed at doctors to “get with the guidelines.”

    The association's decision in 2000 to move alteplase from an optional to a highly recommended treatment for stroke was based on a five year trial by the National Institute of Neurological Diseases, published in the New England Journal of Medicine(1995;333: 1581-7). After reports in the BMJ in 2002 saying that most of the association's experts had ties to the drug's manufacturers, the trial was reanalysed (7 June, p 326).

    The panel, chaired by W Michael O'Fallon, a professor of biostatistics, said that analyses confirmed the trial's finding that alteplase, delivered according to its protocol, reduced disability in patients with acute stroke.

    David Faxon, president of the American Heart Association, has countered claims of links to the drug's manufacturers, saying that “all those who developed the guidelines adhered to…stringent conflict of interest policies and procedures.” But there still remains considerable concern over use of the drug.

    The Society for Academic Emergency Medicine, for example, states: “Ongoing controversies surround the use of thrombolytic therapy for acute stroke… It is not yet clear whether the treatment risk is outweighed by the likely therapeutic benefit” (Academic Emergency Medicine 2003;10: 805).

    “Many physicians are very reluctant to prescribe tPA [alteplase] for acute stroke, so the proponents have decided to take a political approach and achieve their aims through legislation,” said Dr Phillip Brewer, assistant professor of emergency medicine at Yale University and president of the Connecticut chapter of the American College of Emergency Physicians.

    Connecticut has just enacted legislation to establish stroke centres, despite the recent publication of a study involving all stroke patients in the state who were treated with alteplase that showed that overall in-hospital mortality was higher in the Connecticut cohort (16/63 (25%)) than in the original National Institute of Neurological Diseases cohort (40/312 (13%)) Archives of Internal Medicine 2002;162: 1994-2001w).

    But advocates say that when the protocol is followed alteplase can work. Dr William Barsan, chairman of emergency medicine at the University of Michigan, said, “The Connecticut study would seem to support that the safe use of tPA for acute stroke is dependent upon following appropriate guidelines which are well established.”

    However, Dr Greg Henry, associate professor of emergency medicine at the University of Michigan and a nationally recognised medicolegal expert, said that the legislation is “totally political.”

    “It's a back door to find support for tPA,” said Dr Henry, who is serving as an expert on about a half dozen malpractice cases against doctors who did not give alteplase for stroke.

    Brigid O'Brien, spokeswoman for Congresswoman Lois Capps, who is the sponsor of the Stroke Treatment and Ongoing Prevention Act, said that her office was unaware of any controversy surrounding alteplase.

    The American Heart Association and the American Stroke Association declined to respond to questions about their support for the act.

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