[RhondaH]

At the Genentech stockholders' meeting (I am not one) they were asked about their post-marketing surveillance and described their's (finding out what problems people were having with their drugs after clinical trials are over and they are being used by greater numbers of people--when more people take a drug, new problems are usually discovered which may be rare or only happen in a subgroup of patients). The Wall Street Journal had recently had an article on how drug companies often fail to do sufficient post-marketing surveillance as they are not motivated to do it (it doesn't increse "the bottom line" and may even hurt it) even though they are obliged by the FDA to do so.

Genentech answered that they have a postmarketing surveillance system which is an industry leader, setting an example for other companies. I am wondering if anyone on Herceptin has filled out any questionnaires for Genentech or if they are merely relying on the oncologists to pass on patients' complaints and problems. Particularly those who were on the trial--have you been contacted by Genentech. I have not filled out any questionnaires, I was not in the trial.

I propose that those who post her (and the lurkers, too) put in their two cents worth about their symptoms AND particularly whether they are on every week or every three weeks as nothing has been published on this as this is one big experiment (a wonderfully successful one!) I began every three weeks Herceptin 8/18/05 (last one will be 8/10/06) after my 1st 2-3 infusions, I developed a rash under my affected breast, but this eventually went away. My liver enzymes became raised so they switched to every week (this was after Thanksgiving prior to Christmas) which seemed to help, so my onc said that it would be safe to say the Herceptin "irritates my liver a little", but he let me go back on every 3 weeks as I didn't like going in every week. I also had bad sinuses, but that seems to have subsided, but the "fogginess" began and continues w/ Herceptin. My surgeon said "they say there are no side effects, but that isn't true" he had a patient on it who had a "wierd" feeling in her foot, he told her to stop it and she did and it went away. I was also , dizzy for a while (until Jan), but that TOO has gone away. I sometimes wonder if some side effects are "psychosomatic" as mine disappear when I have it tested...hmmm.

I propose you list whether you are on it for early bc(what stage) Stage 1 or Stage IV, how long you have been on it 8/15/05, when symptoms started, what symptoms you had that you didn't have on chemo, how long since chemo ended you started(and what chemo regimen you had) 5/18/05 (6 rounds of dose dense TEC (Taxotere, Epirubicin and Cytoxan), whether you are getting anything concurrently with Herceptin vs Herceptin alone Herceptin alone and if you had any other preexisting diseases or any other preexisting diseases for which you take regular or semiregular medication eg,heart problems, epilepsy 30mg Phenobarbitol, asthma, GI problems, etc--also whether the Herceptin problems caused you to stop for any period of time, take another medicine to reverse the problem Herceptin MAY have caused (eg. sleeping pills for insomnia, stomach pills for nausea, heart pills for heart failure, etc)

Feel free to list minor complaints such as nail cracking, skin cracking, nose dryness or nosebleeds, dry eyes,change in hair, and gas as well as nausea, diarrhea , shortness of breath or air hunger (the feeling of having difficulty being satisfied by the amount of air you inhale), swelling of hands and feet(change in ring size), minor sun sensitivity, rib pain, back pain or other bone pain, joint pain in hands and/or feet or other joint pain, etc. Please also list things under questionable such as weight gain, changes in vision or teeth, improvement or worsening of neurologic symptoms( whether brought on previously by chemo or otherwise), changes of mood ornery, difficulty finding words they totally escape me, increased hot flashes etc. Please alsor remember to list your ER status ER+ and whether you are pre/post menopausal though haven't had a period since 4/05 and if you are on Lupron shots and/or antihormonals concurrently with herceptin. If you are post-menopausal it would help to know for how long (ie,whether you were likely to be having hot flashes anyway etc)

I would hope that this "unscientific" study would be good enough to submit to Genentech so they can cross-check it with their industry-leading postmarketing surveillance. THEY HAVE A GREAT DRUG. Let's see if we can help them have GREAT INFORMATION available to those taking the drug as to what (hopefully) little problems they might expect. Obviously this is a scewed study, as those with no complaints won't reply (although I encourage them to!)

Thanking everyone who participates! (Please feel free to add new questions if I am certain I have forgotten some and certainly new symptoms or problems as I am sure there are many not listed)

Lani

Rhonda


And thats MY 2 cents worth