The term "off-label" refers to use of a drug for treatments not approved by the Food and Drug Administration (FDA). In the US, physicians are essentially autonomous, and when a drug is approved by the FDA for use in the treatment, for example, of epilepsy, any physician can write a prescription for the same drug to be used in the treatment of any other disease or condition, no matter what the evidence (or lack of it) supporting that use.
Let's draw a parallel. A research scientist in an advisory capacity, to government or industry, for example, who recommends a course of action purportedly based on his scientific knowledge, when he knows but hides the fact that there is no evidentiary scientific support for his recommendation, and that given the absence of data, his recommended course of action may be harmful -- that scientist is practicing junk science.
Similarly, a physician, in an advisory capacity to a patient, who writes a prescription for a drug for that patient, a recommendation purportedly based on the physicians's medical knowledge, when the physician knows but hides the fact that there is not sufficient evidentiary medical knowledge to justify the use of that drug in the case of this patient, and the physician is aware that because of the possibility of unknown side effects the drug may be harmful to the patient -- that physician is practicing junk medicine.
The crux of one of the important problems of modern medicine is clear: junk medicine, as described above, is rampant, just as useless and as potentially dangerous to the patient as witchdoctoring, and in the large a public danger of the first magnitude. Physicians are too often mere devices to facilitate a commercial transaction between their patients and drug companies, and the drug companies are well aware of this and devote an enormous amount of energy, time, and money to capturing and using their physician sales-facilitators. The drug business has succeeded in thoroughly corrupting the practice of medicine. To pharmaceutical companies, physicians practicing clinical medicine are sales-facilitators essentially bought the way actors are bought to wear white coats in front of television cameras while pretending to be physicians.
A second problem concerns medical research, or more aptly biomedical research, since these days so much medical research is coupled to modern biology, to molecular biology and biochemistry. During the past twenty-five years, we have witnessed a dangerous corruption of biomedical research by private enterprise, particularly by the large pharmaceutical companies -- "big pharma." Most observers agree that this corruption began in the US with the passage of the Patent and Trademark Amendments Act of 1980, known as the Bayh-Dole Act (named after Senator Birch Bayh [D-Ind.] and Senator Robert Dole [R-Kans.]). By enabling universities and small businesses to patent discoveries emanating from research sponsored by the National Institutes of Health (NIH) and then grant exclusive licenses to drug companies, this act set in motion processes that completely altered research in biomedicine, brought large research universities into partnerships with biotechnology companies and pharmaceutical companies, and pushed a large and important area of modern academic science to focus more on profits than on public benefit. The goose has laid a pile of golden eggs and the eggs may eventually rot and kill us.
In the past, the arena of financial frenzy in America was land, then transportation, then manufacturing. These days the arena of financial frenzy is science and medicine. With a suddenness that has left many older scientists and physicians dizzy, science and medicine have moved to center stage as a focus of commerce. Money flows. A river of money flows into the fields of the knowledge-producers, promotes growth in some places and greed in other places.
This is our era and we cannot go backwards. The age of bedside doctoring in the middle of the night is past, the image a museum-piece of medical history. We live in a time when scientists and physicians strive for large financial rewards for their work, and it's doubtful that will change in the near future. American science and medicine have become profit-oriented endeavors. The problem, however, is not so much profit itself but the effects of the striving for profit by both industry and universities. We need to struggle to ensure that the quest for financial gain does not corrupt the scientific and medical enterprises to a point of destruction. So far, the outcome of our struggle does not look promising.