The delisting, or the switch or whatever you prefer to call it, is one of the hot topics of drug industry strategies. In fact, several factors contribute to making the placement of a successful drug among the OTCs attractive today. In the first place, obviously, the expiration of patent protections and, at least where there are third-party payers, the cutting short of the issues of reimbursements and reference prices. Certainly, however, the big gain would come from entering the self-medication area of chronic disease treatment. A first sign was the arrival of the over-the-counter version of orlistat: it is true that obesity is not, strictly speaking, a chronic condition, or should not be, but it is in any case a more severe pathology than the seasonal or in any case occasional disorders that normally occur. find a solution in the OTC. far more demanding, on the other hand, is the path taken by Merck, for years now committed to pushing the switch of lovastatin to the 20 mg dosage, i.e. the lowest. A choice that has also found the support of even authoritative opinion leaders but which, in any case, the Food and Drug Administration does not like for now.
Commercial reasons aside, there are essentially two reasons for switching to over-the-counter statins. One is of a general order: the prevention of very widespread diseases somehow escapes the public health services, which for economic and organizational reasons cannot follow all those who need it and, therefore, self-management can be an answer. The other reason, which is very American, is that many of those who have a mild-intermediate cardiovascular risk do not have insurance coverage and even those who do do not necessarily get a prescription for these drugs and, one can add, over-the-counter statin would save the cost of the refill visit.
However, the question is not so simple and an editorial in the New England Journal of Medicine recalls it in great detail. Several factors contribute to testify against this innovation, which has already been rejected three times by the ad hoc commission of the Food and Drug Administration. Some are epidemiological and clinical in nature. For example, low-risk individuals identified as primary users have a 5-10% chance of developing myocardial ischemia or infarction within 10 years; with the over-the-counter statin, the risk would be reduced to 3.5-7%, i.e. a limited gain against which even the contained undesirable effects of statins take on a certain significance. In fact, in controlled clinical studies, lovastatin has been shown to reduce the risk of 30%.
It must also be considered that for the passage of a drug to be sold without a prescription it is essential that the individual is able to understand if the single drug is right for him and while it is easy for everyone to understand if he has a cold or head, not so intuitive is the concept of cardiovascular risk. So much so that the only new studies requested from manufacturers in the United States concern the public's ability to understand on the basis of the package insert whether or not they need the drug. Incidentally, those conducted on the statin leaflet have not had encouraging results: even among the volunteers who participated in the studies on understanding and correct use, who are in any case more educated than the general population, less than half correctly established whether they really needed of the drug. Approximately 30% had an even lower risk than 5%, while 24% had a risk
