"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.
Graphic: My photograph of medicine bottle and modified with ArtRage and Picasa3.
posted by Maurice Bernstein, M.D. @ 6:30:00 PM
2 comments
2 Comments:
If you are not comfortable prescribing some drug that you don't know is appropriate you should be willing to say that. If you do marriage counseling and a patient asks you to use hypnosis to help him stop smoking - you should refer them out to someone else. I think this is the same issue. If you don't know enough about the use of a drug for an off label use, and you are uncomfortable experimenting on your patient (even at their request) - refer them out.
WV mike
"..refer them out". Actually, physicians who are aware of phase III pharmacological studies, which determines a drug's therapeutic effect could offer and arrange for their patient to participate as a patient-subject of such a study. Earlier phase II studies could also be offered, though these studies subject the patient to the possibility of receiving a placebo (a treatment which is considered inactive) and not the studied drug.
There is a moral value by the patient's contribution to the benefit of others who are sick by the physician directing the patient to these studies rather than the physician simply attempting "off label" independent use of the drug. ..Maurice.
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