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Mike Mitka

JAMA. 2007;297:1304-1305.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

San Francisco—Some researchers trying to improve the treatment of patients with acute ischemic stroke maintain that the regulatory and reimbursement environment is frustrating their efforts.

These investigators argue that the US Food and Drug Administration (FDA) has created unequal approval thresholds that favor new devices over new drugs. This, in turn, means that devices may become elements of the standard of care before their efficacy in improving outcomes is established.

Some researchers say that the US Food and Drug Administration's lower threshold for approving new devices vs medical therapies makes it easier to gain approval for device-based interventions for ischemic stroke than for new drugs to treat the condition.

In addition, Medicare and other health insurers may be paying hospitals and physicians more for established but less effective therapies. This can make it difficult to recruit health professionals to participate in large-scale clinical trials in which reimbursement . . . [Full Text of this Article]

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