{ "docId": "019dd923-622c-750b-8b9a-21918ac10c17", "docSlug": "f3db2294dcf9", "documentTitle": "Harmony Biosciences (HRMY)", "authorId": "58_Scorpion_Capital", "authorName": "Scorpion Capital", "documentKindSlug": "research-note", "documentKindLabel": "Research note", "sourceTypeSlug": "short_seller", "sourceTypeLabel": "Short seller", "presentationDate": "2023-03-28 00:00:00", "orientation": "landscape", "aspectRatio": 1.3333334, "pageNumber": 329, "pageCount": 366, "prevPage": 328, "nextPage": 330, "slideType": "expose_contradiction", "function": "expose_contradiction", "density": "dense", "nDataPoints": 0, "notes": "The slide uses a Q&A format to document unethical sales practices, specifically the verbal instruction to expand diagnoses to meet off-label sales goals.", "elementsJson": [ "paragraph", "quote_block" ], "metadataConfidence": 1, "imagePath": null, "slideHref": "/slides/019dd923-622c-750b-8b9a-21918ac10c17/329", "deckHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17", "deckJsonHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17.json", "deckAnchorHref": "/decks/019dd923-622c-750b-8b9a-21918ac10c17#slide-329", "components": [ { "bbox": { "h": 0.07, "w": 0.86, "x": 0.07, "y": 0.45 }, "kind": "callout", "text": "Alleged strategy is to push off-label prescriptions for sleepiness in the absence of narcolepsy; company told reps to exploit “vagueness of narcolepsy” to push physician to diagnose it even when it’s not there; “gray areas”", "attrs": null, "subkind": "primary", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "458ec7f0-97a8-419e-a52e-8ac534b9ac3c", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "callout", "text": "It appears that reps would latch onto a patient with narcolepsy and then try to get the physician or their office to expand the diagnosis to cataplexy – even if the patient didn't have it – to “comply” with the label.", "attrs": null, "subkind": null, "toolName": "Visual emphasis", "toolSlug": "visual-emphasis", "confidence": null, "componentId": "019dd953-64d1-73a9-abbe-03dabf744b06", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.35, "w": 0.86, "x": 0.07, "y": 0.07 }, "kind": "paragraph", "text": "When we asked another ex-territory manager if there were verbal, non-written instructions to the sales team to encourage off-label prescribing, he replied that it was to use “the vagueness of narcolepsy...so look for it...gray areas, like once you get that low-hanging fruit...start expanding...you gotta expand the diagnosis of narcolepsy.” We emphasize that Wakix is not indicated as a treatment for narcolepsy: it is only approved for two symptoms - EDS or cataplexy - in patients who have narcolepsy. It appears that reps would latch onto a patient with narcolepsy and then try to get the physician or their office to expand the diagnosis to cataplexy – even if the patient didn’t have it – to “comply” with the label. The rep was clear: “Is it unethical? Yes it is.”; “Yes absolutely, we were told to broaden the scope outside the box” – that is, the label; “Yes, that’s definitely off-label for sure. 100%. Did we ever read that in writing? No. Absolutely not.”", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "4e980893-160e-4603-baf6-042aafe48b72", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.38, "w": 0.86, "x": 0.07, "y": 0.53 }, "kind": "paragraph", "text": "Q: “What were other instructions like that, that they gave the sales team that were verbal and never written? I’m just curious.”\nA: “The vagueness of narcolepsy, saying for CPAP, it’s 30% of patients that fail CPAP are narcoleptic. I have no idea where they got that number from. Thirty percent of CPAP failures, everybody failed CPAP. CPAP sucks. So, somehow, they came up with the number 30%. Tell your physicians that 30% of all CPAP failures are narcoleptic patients, so look for it. Gray areas like, once you get that low-hanging fruit, start expanding. You gotta expand the diagnosis of narcolepsy. But the insurance companies are smart to that. You must have a certain amount of non-REM or failed REMS.”\nQ: “So, they were basically instructions from the company to get the doctor to kind of suggest that the patient had narcolepsy when they may not have it—just to be very liberal with the definition of it?”\nA: “Yes. If you think about it, is it unethical? Yes, it is. However, we weren’t treating narcolepsy; we were treating excessive daytime sleepiness. So, if it works in narcolepsy to treat excessive daytime sleepiness, it is going to work in everyone that has excessive daytime sleepiness. We just didn’t have the indication for it. Idiopathic hypersomnia, unexplained sleepiness throughout the day, that’s an indication that they’re pursuing right now...so yes, definitely to take a look and use it where it’s not a completely fluid narcoleptic patient. Yes, absolutely, we were told to broaden that scope outside the box.”\nQ: “Is that essentially off-label prescribing that they’re suggesting?\nA: “Yes, that’s definitely off-label for sure. 100%. Did we ever read that in writing? No, absolutely not. No. No one would put that in writing.” – Ex-Harmony territory manager for an eastern state", "attrs": null, "subkind": "paragraph", "toolName": null, "toolSlug": null, "confidence": null, "componentId": "ee4e60cd-2b0c-402f-9be1-036cc49cb159", "frameworkName": null, "frameworkSlug": null }, { "bbox": null, "kind": "quote", "text": "“Is it unethical? Yes it is.”; “Yes absolutely, we were told to broaden the scope outside the box” – that is, the label; “Yes, that’s definitely off-label for sure. 100%. Did we ever read that in writing? No. Absolutely not.” — Ex-Harmony territory manager for an eastern state", "attrs": null, "subkind": null, "toolName": "Authority citation", "toolSlug": "authority-citation", "confidence": null, "componentId": "019dd953-64d1-73a9-abbe-07864475987b", "frameworkName": null, "frameworkSlug": null }, { "bbox": { "h": 0.02, "w": 0.25, "x": 0.07, "y": 0.95 }, "kind": "source-note", "text": "Source: Scorpion Capital consultation calls with experts", "attrs": null, "subkind": null, "toolName": null, "toolSlug": null, "confidence": null, "componentId": "6ee09eef-47cd-4f43-8111-32528fa49d9b", "frameworkName": null, "frameworkSlug": null } ], "metrics": [], "tools": [], "frameworks": [], "arcBeats": [], "loops": [], "imagePathAlt": null, "thumbSrc": null, "thumbSrcAlt": null, "locked": true }