Gilead GS9620 trials, thumbs down, no regard for the patient
They say they want chronic HBV patients. But they won't take you if you were treated before!
Recruiters for this company that conduct clinical trials - talk to patients like we are raw material. Total disregard for people with such a viral infection.
What is the difference between a treated patient before and naive? Taking NUCs is a waste of time, once one stops it he is back to square one, same as the one that has not been treated before.
Common scene, compassion, does not apply to these people given that there is nothing for HBV, and their drug at least as good as interferon and with less sides should be given to people that want and can participate in the research especially if it is going on near where they live.
And yet it is Unobtainium!
There are so many clerical stuff people, pretending doing work at these so called clinical trial facilities, when in fact any doctor or local hospital can monitor most of these drugs sending labs directly to the manufacturer.
They prescribe peg on the outpatient basis, what makes this different?
What I am getting at is that saving costs on people that don't need to be there, can allow a company to expand the clinical trial patient inclusion range.. thus approve these medications faster..
Anyway, I am totally discussed with what I see, American health care system is just GONE!!, it is all about money, there is no human factor at all. We should go in with hidden video cameras to these recruitment centers and tape the interviews and put them out on youtube for all to see, what is going on..
They don't even show you inclusion criteria till you get to the facility, and they don't even let you keep a copy of the agreement they just let you read! Why is that Gilead? Are you afraid it may end up on the forums like this one for people to read?
How can HBV chronically ill patients can be even considered to be a in a placebo group? We are not moneys you know!
Yet again all this is legal and FDA approved. Draw your own conclusions folks. yes, I had a bad a day today, because I am so sick of this.. The most corrupted, heartless industry you will ever deal with. And yes, I said industry - because it is not medicine, how we are treated. This is against all the RedCross principles, and against any principles of a civil society btw if the big pharma companies and their affiliates can do whatever they want..
Don't call it clinical trials. Call it product testing! That is a more appropriate word.. because this is not medicine.
So thumbs down to Gilead clinical trials, and their ethics.
no way, these type of un professional things were not expected, atleast from GILEAD a bright company. shocking, the people like gilead are doing the inefficient, non scientific and shameful things like this.
yes veteran, very correct, it is not medicine now, it has become a booming industry. and if done this way, these things can't be called clinical trial but product testing. and FDA is their DON and God Father.
it must change. and gilead must check their working, because it is quite a reputed company in papients eye, may be thats because we did not know its inside truths. now we know about gilead too.
veteran: I hope the Chinese can release their version of imiquimod pill so we can order it from Hong-Kong to save hassle.
donot hope anything from china though it is very simple for them to launch cheap immiquimoid oral pill. they are now biggest hub of hvb people, but china is care less. china is busy in cheap plastic toys, weapons and cheap mobile phones, this way he wants to become super power. china must understand that being world super power is not only about economy but it is about some real contribution to whole world/humanity, very healthy civilians (to reduce burden on economy which is billions of doller on hep b in china) and leadership in all fields specially cutting edge research and developements. decades ago usa was the leader now its open for all like china, russia and european countries. from recent developements,it seems that russia is taking initiative to take lead. usa is sleeping deep, from long time no developement from usa which proves it as world leader. hep b cure is a good opportunity for them to put their world leadership again. but i think i fabour russia in hep b context.
i m hopefull that there will be something good for us from myercludex b trial.
Read the definitions of trials before you go for a visit...
The study title clearly says "IN TREATMENT NAIVE PATIENTS". Which part you do not understand ?
And by definition its a trial, so if you participate then yes YOUR ARE MONKEY. And how do you imagine to test a new drugs other than by giving it to one placebo group and one normal ? They need to show it in comparison with placebo to be approved that it even works.
I have my copy of trial agreement for another GILEAD sponsored trial, what part do you want me to type here? Sorry to hear you had bad experience, in my case I'm very happy I can get good drugs and tests for free.
As for placebo use in chronic hbv subjects. It is unethical. It is known that imiquimod works against many viruses. They know it from animal testing and preclinical trials. If they did not know it would not go into trial.
With us it is just relevant to establish a doze. That is all.
Besides I dont take anything now which can be considered naive. So you see human factor is not there. And that is upsetting.
veteran : As for placebo use in chronic hbv subjects. It is unethical.
exactly, placebo must be unethical, what is the need to do placebo every time? once they know natural history of a desease, there is absolutely no need to do placebo every time.
placebo is centuries times old concept of medicine, when it was required because at that time very less was studied and documented on natural histories of deseases. nowadays most of the deseas's natural history is well documented in scientific literature and easily available.
placebo may be allowed in deseases where new blood test or monitoring parameters emerged with time (as hbsag in hep b which was not approved before),which were not available before. in these cases placebo may be allowed but otherwise it should not.
DJ... do you still think this is medicine? I mean HOW may stipulations and criteria we must meet? Do they realize other there at Gilead what we live with?
They should just give it to people that want to try it. For god sake! if this thing makes our own interferon, to which there is no resistance, there is really No point in taking nucs, and it should not matter, whether one is VL positive or undetected, treated or naive, since the virus never develops resistance to interferon. All these trials are set up to just inflate the cost of healthcare, nothing more..
Another thing, is that they only give this medication for 5 weeks, And I don't know if this is enough time for most people..
Anyway, as it is based on what I seen this trial gets a thumbs down from me.. to may hurdles to jump over for a sick patient..
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