Absolutely - happened to me - liver injury frmo phase 3 trial. Called IRB, CRO,(both IRB & CRO are for profit private entitities) tried to call pharma, but they have multiple firewalls. Don't even know if the injury was reported. Drug pulled (no notification to me, natch) later that year. Called state atty gen office. They knew nothing, but wanted me to stay in touch because an atty in the office is also a drug study subj. The CRO ended up reimbursing me for the ER copay and sent a 25 dollar grocery store gift card. I signed out AMA at the hospital - couldn't afford inpatient care or OP physician followup.
Absolutely - happened to me - liver injury frmo phase 3 trial. Called IRB, CRO,(both IRB & CRO are for profit private entitities) tried to call pharma, but they have multiple firewalls. Don't even know if the injury was reported. Drug pulled (no notification to me, natch) later that year. Called state atty gen office. They knew nothing, but wanted me to stay in touch because an atty in the office is also a drug study subj. The CRO ended up reimbursing me for the ER copay and sent a 25 dollar grocery store gift card. I signed out AMA at the hospital - couldn't afford inpatient care or OP physician followup.
ReplyDeleteCan you get in touch with me -- Carl Elliott -- about this by email? You can find me at http://www.ahc.umn.edu/bioethics/facstaff/elliott_c/
ReplyDelete