Benefit Risk Management?

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Eva Lou
Veteran Member


Date Joined Sep 2006
Total Posts : 3442
   Posted 3/19/2009 1:13 PM (GMT -6)   
So I get this letter today from these people, Benefit Risk Management, a division of Johnson & Johnson Pharmaceutical Research & Development. The letter goes on to say "Thank you for alerting us to your "experience" while on Remicade. We are obligated to follow adverse events, blah, blah, blah, & have enclosed a medical record release form so that we may obtain your records from your physicians." What ?!?!! #1- what "experience" are they talking about? Yes, I wound up in Intensive Care for a week after an infusion.....2 years ago! And #2- none of my doctors, or myself, have attributed that solely to the Remicade. And #3- how did they get my name & address????? Apparently, Centocor is owned by Johnson & Johnson. And of course, there is no 800# on the letter so I can call & say "What the hell???". I'm leery of signing the release form- what would you guys do? And how do you think they got my info? Or even know about my hospitalization, if that's what they are referring to? A little creepy, no? Very Big Brother-esque.
diagnosed with UC '02
meds-
Asacol- 8 tabs/day
Remicade-10mgs/kg- since 4/07
Imuran- 150mgs/day
various probiotics
Fiber supplement
 
 
 


Scarlet504
Regular Member


Date Joined Oct 2008
Total Posts : 192
   Posted 3/19/2009 1:49 PM (GMT -6)   
Hmh, I once got a letter about UC from the makers of Asacol and I think, your pharmacy has a lot to do with it. I guess - although I don't think they are allowed - they sell their address and give information about your medication to third parties. I have no other explanation why you got this letter and obviously take Remicade since quite some time. I am not familiar with Remicade ... is that something that needs to be prescribed prior to being administered or does your doc arrange for it formlessly? Like I said, I blame my pharmacy for it that I sometimes get letters and mails that have to do with my prescriptions.
Scarlett, 38 yo., TX
Pancolitis since 3/1997
Meds
6 x Asacol a day
75 50 mg 6-MP
Align (probiotic)
Flintstones Complete Vitamins


ediekristen
Veteran Member


Date Joined Apr 2007
Total Posts : 1366
   Posted 3/19/2009 3:43 PM (GMT -6)   
I get all sorts of stuff in the mail since starting Remicade, mainly from Centocor and the program AccessOne, which does the rebate thing. So I'm sure any division that deals with Remicade probably has access to certain information. But I think I would probably be a little uncomfortable allowing them to gain access to all of my medical records, especially since they gave limited information and not even a contact number...
Female, 23, Ulcerative colitis (pancolitis) since 1999; GERD; gastritis; osteopenia in femur head & lumbar spine from long term prednisone use...

Current Meds:
3rd Remicade infusion 3/19/09


snohare
Veteran Member


Date Joined Oct 2004
Total Posts : 2088
   Posted 3/19/2009 4:36 PM (GMT -6)   
nono Don't sign anything unless you know exactly what they are about, and are sure you trust them. It doesn't matter that they are a big well known organisation - if they were really concerned about you they would have contacted you two years ago and wouldn't be screwing up on the details. It is either some kind of legal CYA policy, or a dismally late attempt to research side effects (which they quite possibly don't want to hear about really, because hearing about them makes them legally "real").
By all means, write to them asking them to explain what the context of their request is, stripped of legalese. Ask specific questions to which they must answer yes or no (put on tick boxes, that would be fun for the lawyers !) It would be a shame not to have your experience recorded on a database, just in case it is pertinent; lots of valuable research gets done that way. But, watch out for small print... yeah

jujub
Forum Moderator


Date Joined Mar 2003
Total Posts : 10407
   Posted 3/19/2009 4:44 PM (GMT -6)   
Actually, hospitals and physicians are required to report adverse events to the FDA, which may then require or request that the manufacturer follow up. Nothing sinister about it, this is how they find out things like some of the NSAIDS relationship to heart problems.

You're not required to release your records if you don't want to.
Judy
 
Moderate to severe left-sided UC (21 cm) diagnosed 2001.
Avascular necrosis in both shoulders is my "forever" gift from Entocort.
Colazal,  Remicade, Nature's Way Primadophilus Reuteri. In remission since April, 2006.
"My life is an ongoing medical adventure"
 
Co-Moderator UC Forum
Please remember to consult your health care provider when making health-related decisions.


Eva Lou
Veteran Member


Date Joined Sep 2006
Total Posts : 3442
   Posted 3/19/2009 4:45 PM (GMT -6)   
No, I'm not giving anyone access to me records, unless they can tell me exactly what they are looking for, & how they came to hear about this "experience" in the first place! I imagine your GI has to keep a record of the patients on Remicade, & perhaps submit a list of them to the drug company- in order to track possible adverse effects??? But yeah, 2 years later?!?!?! Come on..... I do plan to do a little digging & see what I come up- will certainly post my findings! As far as I know, Centocor/Johnson & Johnson shouldn't have my info- I have always had insurance while on Remciade, so have never had to deal directly with the manufacturer. Maybe the insurer has to track it, & submit user info. That's a more likely scenario, considering the cost of the drug.
diagnosed with UC '02
meds-
Asacol- 8 tabs/day
Remicade-10mgs/kg- since 4/07
Imuran- 150mgs/day
various probiotics
Fiber supplement
 
 
 

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