Jun 16, 2009 in Drugs and Devices
The ability to prescribe medications for off-label uses (those not explicitly approved by the FDA) provides physicians with the freedom to innovate — a freedom that has enabled the discovery of many new uses for old drugs. For example, physicians prescribed aspirin for the prevention of heart attacks long before the FDA approved its use in that context. Although it lacked FDA approval, the drug was obviously clinically effective.
Photo by Joe Gratz
However, the Washington State Supreme Court recently affirmed a ruling by the Medical Quality Assurance Commission (MQAC) that expands what is considered medical malpractice in Washington State. As a result of loose wording in the conclusion, the ruling sets a new precedent for malpractice and threatens doctors who promote off-label use of drugs and medical devices. (Links to original documents: Supreme Court Ruling, Amicus Brief, and MQAC Ruling).
In 2004, the MQAC found that Dr. Ames committed malpractice (defined by RCW 18.130.180 (4) and 18.130.180 (16)) for using the Life Information System Tens (LISTEN), a diagnostic tool that measures electrical resistance in the skin, for the treatment of allergies. On June 4, the Washington State Supreme Court affirmed the MQAC ruling and concluded that “…no additional expert testimony regarding LISTEN, or Ames’s use of it, was necessary. The evidence presented demonstrated by clear and convincing evidence to a layperson that he was using a machine for purposes for which it was not designed and for which he was not specifically trained. Substantial evidence exists that he led patients to believe that LISTEN could diagnose and treat allergies, when in fact it could do neither, placing these patients at risk of harm” on the grounds that “LISTEN has not been approved by the Food and Drug Administration (FDA) for use in detecting and/or treating allergies, although biofeedback machines have been approved for other uses.”
One-fifth of all prescriptions in the United States are for off-label uses. Of those, 73% had little scientific evidence supporting their efficacy. Also, due to the limited number of studies done on children, up to 62% prescriptions given to children are considered off-label. Cardiac, psychiatric, and allergy drugs have the highest rates of off-label usage, but the practice of prescribing drugs for non-FDA approved uses is also important in the treatment of rare conditions for which no standard treatment or drug therapy exists. If FDA approval required in proving efficacy prior to prescribing medications, then doctors would be unable to pursue the aforementioned methods of treatment.
In the interest of protecting the public from ineffective treatments, the MQAC and Supreme Court ruled fairly in the case of Dr. Ames. However, the Supreme Court went too far in presuming that a lack of FDA approval suggests clinical ineffectiveness. The Supreme Court, in effect, has redefined what comprises malpractice. The legal precedent set by this ruling means the MQAC could potentially charge doctors with malpractice merely for promoting off-label treatments regardless of their actual effectiveness. As a result, the Supreme Court’s decision could greatly discourage medical innovation by Washington’s doctors and limit the number of treatment options available to patients with rare conditions.