This is the first I heard of this. I am a Prove 3 patient.
The lawsuit basically says that Vertex failed to report unfavorable information in Prove 2.
My hope has been the Prove 2 data that geno 1s receiving VX950+RBV+INF for 12 weeks followed by 12 weeks SOC and experienced RVR....the odds are quite high.
Does anyone have information about what the unfavorable data was for Prove 2?
anonymice...thanks for the post.
Great idea, this class action stuff!!!
Now instead of using time, energy, and money to develop drugs that might even save the lives of some of the members of this forum, lets saddle Vertex with lawsuits. These lawsuits will, of course, greatly benefit the greedy, money-sucking lawyers and perhaps a few short term stock speculators but will harm millions of people around the world with hepc and other diseases.
It will even harm those stock investors who bought have bought the stock with the hope that eventually VX 950 will be approved and will result in an increased cure rate for those who would not be cured by existing medications.
Everything that I have seen looks like Teleprevir will increase the cure rate for Geno 1's in less treatment time.
Yea buddy!! Lets continue to drive up the costs of Trials (note the word Trial) so that fewer companies have the money to attempt trials and fewer new drugs will be developed.
Anon, are you are party to this lawsuit or a member of this law firm?
I really think burned74 hit the nail on the head with his post. First off I don't see why anyone would post such negative information on a site where alot of people have benefited from the clinical studies involving Teleprevir. It just doesn't make any sense, I doubt if anyone on this forum bought any stock from Vertex. So anonymice can you explain your thinking on posting this information. The way it appears, and I could be wrong but it looks like you're just trying to stir up some dust or drum up business. I don't get it, please explain as I don't like being wrong. I've heard that it takes around 10 years to get an investigational new drug registered with the fda. The studies that are being conducted currently around the world are helping quite a few people and so what if Vertex gave incorrect infomation? It could have been an innocent mistake and even if it wasn't the drug has obviously showed enormous potential so where are you coming from on this subject???
My heart sank as I read this. I have been trying to get a call back from a couple of different places regarding Phase 3 trial locations and after leaving many messages, not one call back from my local centers. Someone from Vertex did respond, left me a voicemail saying to just keep checking the clinical trials site. Wish I hadn't missed the call so I could have spoken with them.
I thought, great, maybe this is causing delays for anything moving forward. I keep checking clinicaltrials and nothing more is posted as we near the end of March.
I am so bummed and I suppose reading more into this than there really is. I am having some real ups and downs here after getting bad news from HR (feeling real stupid that I put off treating for two years when it turns out I was a stage 4).
Do you think that they are just behind schedule as usual or will this lawsuit mess things up for Phase 3?
I agree with Susie.
"The pharma companies often manipulate the trials to make the drugs seem better than they are. They handpick participants, report great SVR rates but don't mention the trial disqualified anyone with late stage disease or genotype 1.....stuff like that."
IMO too many people on this forum take the SVR percentages from the drug company studies as gospel. OH COME ON. These people are not doing us any favors. They are trying to sell a product.
I have talked to several GI's and a hepatologist not involved with clinical trials and they all said do not trust the SVR rates. They are false. My own GI told me last week the real rate is now closer to 30%. Not 50%. All the information on Clinicalcareoptions dot com is from is good current info but the DR's are involved in the clinical trials and basically work for the drug companies.
Please keep an open mind when reading the trial info. I know most of us are hoping that the SVR rates are true (even myself) because we want to be cured in such a bad way. But hoping will not cure us.
Well thanks for putting a different spin on this issue and this includes what Bobby1952 had to say. If you can't trust the clinical trial reports or even the people who work at the clinical trial sites then who can you trust? Sure I will be doing more homework on the subject but I'll give you an example here. The nurse I spoke to at the training hospital near me who gives some of the clinical trials gave me an SVR rate closer to 70% and she said that is going on with the current study that started in Dec. 2007 or Jan. 2008. What gives? Is she being deceived or is she intentionally saying that to make their numbers sound better to recruit me. Dang!! I'm good to go and I'm tired of waiting I have two choices I can go with the regular insurance or I can go with a clinical study. Any advice on this?? I know it's a personal decision I will have to make on my own but if you can throw me a bone to chew on, so to speak, please throw it my way... thanks
To be honest, I do not know enough about what was or was not being said by management to give rise to the class action suit. But if they were misleading the public for their own personal gain, or the companies gain, they were not only misleading investors, but also those patients who were influenced incorrectly into postponing regular treatment in the "hope" that this drug was just around the corner.
While I would like to see a miracle drug, I fear that it will be a long time before something as well understood and effective as current combination therapy comes along, despite the marketing hype otherwise.
With regards to past studies done on Telaprevir, I believe the results are public and I believe have been presented at past years at the AASLD and if you google for such things you may find them. You do have to read study results with your own critical eye and look at the variables and controls they used to see if it skews the data in any way that causes a question mark about the results they put out. I never take any study at face value without reading it from various angles.
I also think it's important, yet dismaying to read the post that started this thread. When you enter a trial, you read the data from the past trials and you hope like hell that it's accurate because that's partly what you're basing your decision on whether you enter the next phase of that trial. If the success rate is lower than stated, maybe you'd choose regular SOC that you can manipulate, for example.
As SusieQ said and I quote: "Who knows., you may help someone make a decision whether or not to enter a trial or wait for approval of the drug. "
I say Right On. I would be very upset if a pharmaceutical company skewed their data and had people entering trials based on skewed data and hindering our ability to make good decisions for ourselves.
There are also people making decisions on whether to treat now or wait for new drugs to come along and having accurate data on those drugs is also important.
Now........I haven't read this article or other articles pertaining to this and it could be that the suit is smoke and mirrors. So just because a lawsuit has been launched doesn't make it so .... but I'd think we all have a vested interest in knowing the answer to that, seems to me.
The Vertex management probably hyped the stock more than they should have, but I am unaware of any study that shows such a poor response to Telaprevir. I have only my own personal experience with it and the accounts of others on this board.
In my previous tries with SOC, I experienced a 2 log drop by week 12 and undetectable by week 24. With Telaprevir, my viral load went from 8,000,000 at the start to >30 in one week and undetectable by week 2. This is after 7 previous tries with various flavors of interferon and ribaviron. My personal experience and that reported by Vertex a couple of days ago shows this to be one of the most powerful new drugs if not the most powerful.
Listen to the latest presentation on the Vertex web site.
then why did this (albeit small) sample of people who came on here and were part of the trials....have such relatively good rates? I forgot how many exactly, and what everyone's outcome was.... but I think most of them SVRed right? maybe I'm wrong on this...course you can't deduce much with such a relatively small sample of people, but I might think differently, if, within this relatively small sample, most of them didnt svr...but they did...someone correct me if I'm wrong...thanks....
Boohoo for the poor corporation that falsified data to drive their stock price up. Demanding some type of accountability from them isn't what raises the cost of medicine.
I think the acusation, is that they not so much falsified data, as hid data, which was less favourable.