Experts: Restrict Off-Label Prescriptions
> 10/30/2008 6:18:59 PM

The act of recommending certain medications for uses other than those for which they've been approved by the FDA is a longstanding practice. Doctors may, working from their own experience, prescribe drugs for alternate purposes. But in  releases sent to practitioners across the country, manufacturers also mention “off-label” uses for their products, encouraging doctors not to limit their prescription to the treatment of the conditions for which they were designed. The practice may, at times, lead to breakthroughs that ultimately benefit the public. Several anti-depressants, for example, have been found to restrict the physical urges common to long-time smokers. But if one judges by the statistics collected by a team of pharmaceutical experts and released in a recent Public Library of Science article, the practice is extremely common and its results are very often unclear. Further government regulation may be required to restrain excessive off-label prescription.

While doctors often (legally) use their best judgment to prescribe medications for alternate conditions, the promotion of such practices by manufacturers is illegal. And yet it continues en masse via mailers and “decoy indications” used to solicit FDA approval for drugs whose most effective purposes have yet to be determined. Approximately 150 million off-label prescriptions occur in the U.S. each year according to the research conducted for this release. Unfortunately, the primary goal of such efforts is the maximization of profit. Even if off-label prescription only occurred on a very limited scale, pharmaceutical manufacturers would still able to elevate their overall sales numbers by effectively freeing doctors to prescribe medications at their own discretion and creating an increasing demand. And the trend is surprisingly common, which is why these industry veterans recommend legal action and a revision of standards to prevent wanton off-label prescription practices. In order to curb the industry habit of working around established standards, the publishers recommend fines and increased scrutiny of offenders by federal industry watchdogs.

This issue applies to the mental health field in a great number of cases; anti-depressants that double as smoking cessation drugs are not the only example. Prozac, the prototypical anti-depressant, was also cited by its promoters for possible use in the treatment of lupus, migrane, ADHD, irritable bowel syndrome and premature ejaculation. If prescribed for these conditions, the medicine would accomplish very little beyond the infamous placebo effect. Yet manufacturers continue to suggest, with an implied wink, that their wonder drugs may very well serve even more disparate purposes. And why shouldn’t they? While Pfizer lost more than $400 million dollars in a case spurred by the fact that nearly 90% of patients taking their epilepsy drug Neurontin did so off-label, such public indictments are rare. And profits remain buoyed by the practice.

Another prominent example of unsupervised off-label prescription practices involves giving drugs to groups who were never represented in formal study, most often young children and pregnant women. Since a great majority of studies do not include them, most of the drugs given to these populations have not been tested and any adverse side-effects will arrive unexpected. If a doctor wishes to prescribe in this fashion, he or she should, at the very least, inform the affected patient or responsible party of the noted lack of relevant research. Concerns over the prescription of psychiatric drugs to young children are warranted as research has yet to determine these medications’ ultimate effects on neurological and social development and adverse events have been reported. The off-label usage of certain meds should, ideally, be studied in clinical settings before any medical professionals prescribe them to private citizens. And any children taking these drugs must be very closely monitored.

This is not to say that off-label prescription practices should cease altogether. The opinions of these experts do not amount to a condemnation of the entire prescription drug industry or its representatives. FDA approval only covers marketing practices and the final word on medication type and dosage should lie with the individual practitioners, who know their patients far better than any federal agency. We have no doubt that, in quite a few cases, the flexibility of these medicines proves very beneficial for doctors, manufacturers and, most importantly, patients. Medications designed for one purpose may ultimately prove more successful in treating completely unrelated conditions. Certain anti-psychotics, for example, are now effectively used for the treatment of dementia-related agitation. But when the opposite is true and the medications prove ineffective or harmful, such actions amount to a violation of the public trust, and irresponsible treatment methods cannot be forgiven when they hurt the very people they’re supposed to help. The obvious conflict of interest that exists between doctors and pharmaceutical manufacturers cannot be a net positive. Pharmaceutical companies should be punished for pushing off-label uses with no underlying research. And patients should be encouraged to research their medications and ask their doctors about the safety of any off-label prescriptions.

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