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"No.. Not Yet":Answering the Patient's Request for "Off Label Use" of a Drug
In the United States, physicians can legally write a prescription for a drug to be administered to a patient with a disease not approved by the Food and Drug Administration (FDA) for use, so-called "off label use" if that drug has already been approved for use by the FDA for some other disease. Often, patients and their families faced with a serious disease and unresponsive to any beneficial action by the available drugs for that condition may, after learning from the media of "promising results" from preliminary drug studies for that disease insist that their physicians prescribe that drug. The "promising results" may be more supposition based on elementary animal studies of the patient's disease and not as yet studied in humans with that disease. Yet, such "results" are readily documented by the media and thus available for the public to consider and desire.
Physicians practice under the ethical obligations of their profession to be beneficent in their actions with the patient and to avoid harm. Such beneficence would include to attempt to attain a goal of "cure" for the patient's disease. But what if the "cure", at present, was only theoretical and not documented by valid testing in humans? To "avoid harm" is another matter of concern since if approval of the drug was carried out in studies or experience with a disease other than that experiencing by the current patient, can the physician be sure that the drug will be equally safe?
The ethical issue is how should a physician respond to a vigorous and understandable request by a patient or family member for the doctor to prescribe a drug as "off label" for a critical illness, not responding to prior drugs, but a drug which has not been approved by the FDA for such use and whose benefit/safety value for that disease has not been proven but only suggested by the media?
Should what is read by the public on a website or newspaper or heard on TV be something to challenge the doctor? And does the doctor have the time, knowledge and ethical strength to defend any refusal to follow the request and finally say "no.. not yet." Or at a certain end-point of an illness, the refusal itself is unethical? ..Maurice.
p.s.- For more on this topic: "The Ethics of Early Evidence---Preparing for a Possible Breakthrough in Alzheimer's Disease" by Lowenthal, Hull and Pearson in the Perspective Section of August 9 2012 issue of the New England Journal of Medicine.
Graphic: My photograph of medicine bottle and modified with ArtRage and Picasa3.