Scooby, you likely read the same post as I or a post I made passing this info on a couple of days ago. After reading the information I confirmed myself that there is a Rebif PML case in the just released FDA Adverse Event Reporting Database for Q3 2005. I also confirmed the existence of the earlier Avonex monotherapy PML case in the database. I found the reports by downloading data direct from the FDA Adverse Event Reporting Database here:
http://www.fda.gov/cder/aers/extract.htm
Everyone can do the same by downloading each quarterly zip file and then extracting the zip and you will see several large files. Using Wordpad I searched each file for 4747129 to see all records for the reported Rebif PML case. Below is what I found. After that is data I found for the March 1 2005 Avonex monotherapy PML case.
I agree with Harry, there is so many patient years of experience any risk should be very low. The significant interest to me and I'm sure others is all about better assessment of Tysabri monotherapy PML risk. If you are about to start Rebif I wouldn't let these reports dissuade you.
DEMO05Q3.TXT (Patient Demographic and Administrative Info)
4747129$5865713$I$$4747129-6$$20050802$20050815$EXP$2005109935$PFIZER INC$41$YR$F$N$$$20050812$MD$20050224$$$UNITED STATES$
DRUG05Q3.TXT (Drug/Bilogic Info)
4747129$1006329862$PS$METHYLPREDNISOLONE SODIUM SUCCINATE$1$INTRAVENOUS$1000 MG (500 MG, 2 IN 1 D), INTRAVENOUS$D$D$$$11856$
4747129$1006348446$SS$INTERFERON BETA-1A (INTERFERON BETA)$2$INTRAMUSCULAR$(30 MCG, 1 IN 1 WK), INTRAMUSCULAR$D$D$$$$
4747129$1006348448$SS$ALL OTHER THERAPEUTIC PRODUCTS (ALL OTHER THERAPEUTIC PRODUCTS)$2$INTRAVENOUS$(300 MG, 1 4 WK), INTRAVENOUS$D$D$$$$
4747129$1006348449$C$DONEPEZIL HCL$1$$$$$$$$
4747129$1006348450$C$TIZANIDINE HCL$1$$$$$$$$
4747129$1006348453$C$GALANTAMINE (GALANTAMINE)$2$$$$$$$$
4747129$1006348454$C$CITALOPRAM (CITALOPRAM)$2$$$$$$$$
4747129$1006348455$C$ROFECOXIB$1$$$$$$$$
4747129$1006348457$C$TRAMADOL HCL$1$$$$$$$$
REAC05Q3.TXT (ALL MedDRA terms coded for the adverse event)
4747129$CACHEXIA$
4747129$CONDITION AGGRAVATED$
4747129$MULTIPLE SCLEROSIS$
4747129$PNEUMONIA ASPIRATION$
4747129$PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY$
4747129$ROSAI-DORFMAN SYNDROME$
OUTC05Q3.TXT (Patient Outcome for the adverse event)
4747129$DE$
4747129$HO$
4747129$OT$
RPSR05Q3.TXT (reporting source for event)
4747129$HP$
THER05Q3.TXT (start dates and end dates for each drug therapy)
4747129$1006329862$20010316$20050109$$$
4747129$1006348446$20000201$20050101$$$
4747129$1006348448$20020412$20050118$$$
INDI05Q3.TXT (MedDRA terms coded for the indications for reported drugs)
4747129$1006329862$RELAPSING-REMITTING MULTIPLE SCLEROSIS
4747129$1006348446$RELAPSING-REMITTING MULTIPLE SCLEROSIS
4747129$1006348448$RELAPSING-REMITTING MULTIPLE SCLEROSIS
==================
4599260
DEMO05Q1.TXT (Patient Demographic and Administrative Info)
4599260$5756178$I$$4599260-6$20040119$$20050302$DIR$$$$$F$N$100$LBS$20050301$CN$20040430$Y$N$
DRUG05Q1.TXT (Drug/Bilogic Info)
4599260$1005752402$PS$AVONEX$1$$INJECTION WEEKLY$$$$$$
REAC05Q1.TXT (ALL MedDRA terms coded for the adverse event)
4599260$GENERAL PHYSICAL HEALTH DETERIORATION$
4599260$HALLUCINATION$
4599260$JC VIRUS INFECTION$
4599260$PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY$
4599260$PYREXIA$
4599260$THERAPY NON-RESPONDER$
4599260$UNEVALUABLE EVENT$
4599260$URINARY TRACT INFECTION$
OUTC05Q1.TXT (Patient Outcome for the adverse event)
4599260$DE$
4599260$HO$
RPSR05Q1.TXT (reporting source for event)
THER05Q1.TXT (start dates and end dates for each drug therapy)
INDI05Q1.TXT (MedDRA terms coded for the indications for reported drugs)