Thread by @JillPiggott

#Migraine patients were excluded from Eli Lilly's trial of #Emgality 300 in which 71.4% of people got +50% reduction in #headache days. Only 28% of people taking 120 mg hit this benchmark. Trial exclusion means FDA did NOT approve 2.5x more effective 300 for CM. @LillyPad thread

Trial exclusions determine FDA "labeled" usage. Insurers routinely cover off-label use of inexpensive meds & deny off-label use of expensive meds. Eli Lilly priced #Emgality high: $6,900/year. investor.lilly.com/news-releases/…

Both #cluster & #migraine are profoundly disabling diseases w/ overlapping symptoms. #Emgality treats both. People fully disabled by 1 are no more/less disabled than people fully disabled by the other, so why did Lilly assume #cluster required nearly 3x more med?

#Cluster affects 9x more men than women. Cluster patients have a special status among doctors. In "Conquering Headache" (2003), 3 prominent male neurologists describe cluster as "so excruciating that it brings even the strongest of men to their knees" (p 13).

.@WHO ranks severe #migraine in highest class of disease burden, along w/ terminal-stage cancer, quadriplegia, & active psychosis. Yet migraine (which affects 3x as many women as men) is undertreated. Lilly's #Emgality trial design is as shameful an example of this as any.

Inexplicably, Eli Lilly failed to consider its own shareholders when deciding to include only #cluster patients in its trial of #Emgality 300 trial. There are 40 times as many Americans w/ chronic #migraine as there are people w/ #cluster. @LillyPad

.@headsUPmigraine has heard from both neurologists & patients that #Emgality 300 mg can, indeed, have superior results compared to 120 mg for people w/ limited response to the lower dose. This is life-changing for patients fully disabled by intractable, continuous #migraine.

2/2019, Eli Lilly announced that full-year 2018 revenue increased 7% to $24.556 billion. “The company now anticipates 2019 revenue between $25.1 billion & $25.6 billion. … Revenue growth is also expected to benefit from the recent launch of #Emgality.” investor.lilly.com/news-releases/…

.@headsUPmigraine calls on Eli Lilly to fund & submit to FDA a small trial of #Emgality 300 for chronic #migraine so patients can receive insurance coverage for its $1,600/year med. @LillyPad

headsUP urges Eli Lilly to immediately open its 1-year trial of #Emgality 300 mg to those intractable #migraine sufferers identified by doctors as likely to benefit from the higher, more effective 300 mg dose. @LillyPad docs.google.com/document/d/e/2…

@threadreaderapp #unroll