A named-disease is a kind of umbrella-top seen from above, and who that named-disease actually refers to walks under that umbrella. The old publication strategies sought to extend the drug’s use to other ailments. It begins after FDA approval, downstream. There is an umbrella with disease “A” painted on top, and another umbrella with “B” painted on top. The drug is only approved for those under the umbrella with “A” painted on it. Pharma uses its approval for one named-disease to cross-sell to another, unapproved named-disease. This is off-label marketing.
The new publication strategy seeks to extend the patient selection procedure, invisibly redefining patients, to bring other ailments under a single label.
The strategy seeks inaccuracy in order to widen a single umbrella, and keep the same paint on top, “FH.” Now it brings other diseases from under their own umbrellas to share this same umbrella. Under this single “FH” umbrella there are now non-FH. This occurs upstream from the FDA’s involvement. This is on-label only as far as community consciousness has accepted the upstream redefinition of what goes by the name of “FH.”
The old publication strategy took place after FDA approval. The new publication strategy begins before the FDA’s involvement. So later the FDA approves the PCSK9 drugs for HeFH, and, in name only, rejects pharma’s attempt to put Non-inherited Hypercholesterolemia on the label: clinical scoring systems guarantee that large numbers of prescriptions will go to Non-inherited Hypercholesterolemia.