Saturday, November 21, 2020 9:40:07 AM
I agree Raf. It's one thing to accept willingly, with full knowledge, and receive compensation (in terms of pocketbook savings) to switch a brand drug for a generic, knowing full well that there may be less API and different excipients, and acknowledging (patient and physician) that when the trial of efficacy was performed, it was actually the brand, not the generic drug, that was confirmed as biologically efficacious. It is however quite another thing, to be prescribed a brand drug for one life-saving indication, and then defacto have this brand drug switched by a third party for economic interest, unbeknown to the patient (or physician) to a generic drug (that has never been actually tested clinically) and only authorized for a short term (12 weeks) niche indication, not a critical long term life-determining cardiovascular indication. The doctor-patient contract has been broken without informed consent or knowledge of consequence. I understand public necessity and economics that motivated the whole pandora's box of Hatch-Waxman skinny labeling, but we have now crossed a bridge too far and unless there is a public outcry against this practice, there will be grave consequences for patients' lives. It's high time our medical bodies litigated this reprehensible behavior that undermines the basic precept of doctor-patient trust and holds the high court toes to the fire until they take a position. The FDA's reassurance that there is maybe, close to 1 of IPE in a gen V capsule, and that regardless of the efficacy or otherwise of the excipients, that none of them will have unignorable short term toxicity does not well my soul with trust or confidence.
HK
HK
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