VX-950 Class Action Sec. Fraud

I have been an reader of these boards for several years - (don't participate - just mostly read).  I was interested a few years ago in the data on the Vertex (VX-950 Telepravir) Prove 1 Prove 2, and the ongoing trials.  It's been a while since I came by to see how the trials were doing or how folks in the trials were doing.  The boards have changed since I've been by (been a few months).   I don't see much "talk" on VX-950 on the boards (not like I used to - might be because I'm not looking in the right place), but anyhow - I came by to see if anyone had posted on the class action law suit that's been filed against Vertex (on behalf of investors / stock holders).   Was just wondering - have you all heard this?    I've gotten several news alerts on it in the last several days.   Thought some here might be interested.  You can read the complaint filed by going to the several law firms representing the plaintiffs if you're interested in seeing it.  Just google Vertex Class Action.   I've quoted from one law firm here without using their names  (don't know if that's allowed - if not - sorry.)   There is a deadline for investors - May 12,2008.


Symbol:  VRTX
Purchase Dates:  June 12th, 2007 - November 2nd, 2007
Deadline for Filing Lead Plaintiff Motion:  May 12th, 2008
Download the Complaint:  Vertex Complaint.pdf

March 18, 2008 - The law firm of Schatz Nobel Izard P.C., which has significant experience representing investors in prosecuting claims of securities fraud, announces that a lawsuit seeking class action status has been filed in the United States District Court for the District of Massachusetts on behalf of all persons who purchased the publicly traded securities of Vertex Pharmaceuticals, Inc. ("Vertex" or the "Company")(NASDAQ: VRTX) between June 12, 2007 and November 2, 2007, inclusive (the "Class Period").

The Complaint charges that Vertex and certain of its officers and directors violated federal securities laws. Specifically, defendants’ statements regarding the development of Vertex’s HCV protease inhibitor, telaprevir or VX-950, for the treatment of hepatitis C and the PROVE 2 trial were materially false and misleading because they failed to disclose unfavorable data regarding VX-950 from the PROVE 2 trial compared to PROVE 1. Specifically, PROVE 1 showed that patients taking VX-950 experienced 16% greater total viral reduction after twelve weeks compared to the control group. The results of PROVE 2, which defendants did not disclose during the Class Period, showed an advantage over the control group of only six percent. When the truth was disclosed on November 2, 2007, Vertex’s stock price dropped from $31.64 to $24.08 in two trading days.

If you are a member of the class, you may, no later than May 12, 2008, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a class member that acts on behalf of other class members in directing the litigation. Although your ability to share in any recovery is not affected by the decision whether or not to seek appointment as a lead plaintiff, lead plaintiffs make important decisions which could affect the overall recovery for class members.

[miked]

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.

miked

[burned74]

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?

[fretboard]

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???  

[foofighter]

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?

[Bobby1952]

   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.

Bobby

[fretboard]

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  

[moahunter]

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.

[Trish77]

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.

[Andiamo1]

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.

[Forseegood]

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....

[desrt]

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.

[moahunter]

I think the acusation, is that they not so much falsified data, as hid data, which was less favourable.

[moahunter]

When this less favourable data was released, the stock price dramatically dropped - so investors are asking, why the slow rate of release? Why were people sitting on this information (if they were sitting on it)?

[susan400]

I had a remarkable drop in the first 2 weeks with my viral load on the VX.  Yes, I did get the rash.  No, I was not in the group that gave the Riba.  I was randomized into group C - the no Riba group.  I have no complaints with the Vertex group.  The only thing is, I just wish that I had been able to get all 3 drugs and have been able to get SVR (which is the luck of the draw) when you get into randomized clinical trials.    

Susan

[Andiamo1]

I don't think any negative data was withheld.  The stock dropped because the market crashed and one analysts decided that Vertex would have to have a 48 week phase 3 trial.  That turned out to be false based on the latest data on the Vertex site and the phase 3 application.

When all the prove 3 data is in, I think there is a good chance that the drug will be fast tracked for non responders and relapsers. All the prove 3 people on this board that I am aware of, save one, have had excellent results.

[Andiamo1]

By the way, in my paranoid TX state, I came to believe that many of the negative or positive comments about drug companies are attempts to manipulate the stock price.

Personally, based on the latest Vertex data, I am going to buy the stock tomorrow morning.

[Forseegood]

thanks for the positive comments...I just remember seeing the trial participants on here having good results...and I do believe our Susan would have svred had she been given the riba...some reason I just think that...I hope she will at some point , of course...

[moahunter]

Andiamo1 - unlike you, I don't buy and sell stock, so I have no interest in seeing the price inflated or deflated. All I said above, was that the acusation is that information was withheld. I don't know if that was true or not. I do see there are concerns over all the new treatments though. Even if viral load is initially impacted, does that translate into SVR, and is that worth the additional sides (or rash, and who knows yet, what else), for a 7% improvement over SOC (if that is what the reuslts end up as)?

I think it will be a while before that is decided, and doubt it will be fastracked as you suggest, but that is just IMO, based on the limited information and doubt I can see.

[miked]

Everything I've researched says that rapid virological response (RVR) is the ticket to getting SVR (cured).  On Prove 3 trials (like Andiamo) I too was UND at Week 1-2.  Post tx Week 12 I was still UND.  This week I go in for post tx Week 24.  If still UND (hope and pray) I'm considering myself cured. RVR really is THE KEY for the trials and SOC (standard of care).  

Does anyone know what information that Vertex misled on the Prove 2 trials?  

Eric: Sorry to not respond to earlier email, I was just off-tx and messed up. How can we talk offline?  Also congrats on finishing tx.  8x is a charm!

[fretboard]

Ok, I guess I'll hurry up and continue waiting, my wife's friend highly recommended the study to me.  So I will just stick with my original plan, I really hate changing my mind mid-stream anyways.  Patience is a virtue I have so little of anyway, so I will fake it till I make it.  Everything that I've heard and read about Teleprevir is positive and to me it doesn't matter if it's 6% positive or 16% positive it's getting positive results and that's the bottom line.  I'm really enjoying this forum cause I can see things differently from all angles, thanks.

[foofighter]

Do have a Phase 3 trial location near you?

[Andiamo1]

I did not mean to imply that you were trying to manipulate the stock.  You are not the initial poster of this and I don't know what the motivation of the initial poster is.

I do know that people that RVR on Telaprevir have a 95% chance of SVR according to Vertex.  I don't know where the 6%  improvement over SOC comes from, it does not appear in any study that I have seen.  I might certainly have missed it though.

The latest presentation on the Vertex site shows a 25% improvement over SOC in half the time (24 weeks).  That's pretty good in my book.  The doctor I am seeing believes that Telaprevir is one of the most potent new drugs, if not the most potent.

In addition, the 25% improvement factors in dropouts; that number will improve substantially as the research shows how to better manage the side effects and reduce dropout rates.

[Forseegood]

which is only anecdotally of course, I've been here a few years and I've rarely, rarely seen a person who RVRed who did not onto SVR...that's just soc, or the trials...think i have seen it happen, but it's very rare...RVR is the ticket for most people I should think...and it seems that a good percentage of those trial participants rvr'ed...I'd really like to know what ultimately happened to everyone that posted on here who was on the trial, now and in the future....

[Andiamo1]

We now live in an age where people think that if a stock goes down after they buy it that their inherent right to be rich has been violated and they should sue to recover their losses.  I don't buy that.  Anyone that makes a decision to buy a stock based on a speech given by a CEO, would be better off praying to the tooth fairy.  I am not justifying fraud, but I don't think Bogle committed fraud.  

Anyone that makes their own decision about waiting to treat or what experimental drug to take, owes it to themselves to do the proper due diligence.  I am not defending Vertex management's over hyping the drug, but in the end, it is our decision and we should either listen to our doctor's  advice or do the proper due diligence.

So far, the results of the people here taking Telaprevir triple therapy, including me, have been spectacular!  Even mremeet that had the severe rash and had to cut the treatment short did SVR.

[Forseegood]

also, didn't mean to imply that you have to rvr in order to svr...there are many who svr despite not achieving rvr...just meant that from what I've seen, if you rvr...you have an excellent chance of svr...

[jdwithhcv]

Andiamo,
We now live in an age where people think that if a stock goes down after they buy it that their inherent right to be rich has been violated and they should sue to recover their losses.  I don't buy that.  Anyone that makes a decision to buy a stock based on a speech given by a CEO, would be better off praying to the tooth fairy.
--------------------------------------------------------------------------------------------
I agree - lets not lose sight of the subject matter of this lawsuit.  Its an action by investors with a complaint about the value of stock.

Foreseegood,
I've been here a few years and I've rarely, rarely seen a person who RVRed who did not onto SVR...that's just soc, or the trials...think i have seen it happen, but it's very rare...RVR is the ticket for most people I should think...
--------------------------------------------------------------------------------------------
I'm so grateful you posted that, as one who is RVR, thats just the kind of information and insight that I find useful.  Thanks for injecting fresh hope, it helps so much.

[burned74]

I stand by my initial analysis that the main purpose of this and many other class action lawsuits is to make these greedy lawyers rich.  Check out the Vertex website, the law firms website, and combine that with your knowledge of the history of these trials.

The lawyers get a huge windfall IN CASH (somewhere around 40 per cent) while each plaintiff gets some minuscule amount of money or cheap discount coupon for future product or service. I have gotten this type of payment on more than one occasion.

The claim at the beginning of the first thread is that this suit is  "on behalf of investors / stock holders". This is a lot of hogwash. This lawsuit, which according to the law firms website, has not yet been filed, is simply an attempt to extort money from Vertex and is bound to eventually effect research and development, and put that cash into the lawyers pockets.

The criteria and results of these studies have been well documented and are probably not a secret to most people on this forum.

Here is the  wording from the Vertex website last November.

"Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from interim analyses of PROVE 1 and PROVE 2, two large Phase 2b clinical trials evaluating the investigational hepatitis C protease inhibitor teleprevir (VX-950), dosed in combination with pegylated interferon and ribavirin. In 24-week teleprevir-based treatment regimens, genotype 1 treatment-naive HCV patients achieved sustained viral response rates of 61% and 65% in PROVE 1 (SVR 12 and SVR 24) and PROVE 2 (SVR 12), respectively. "

If I read it correctly, the Teleprevir response rate was claimed by Vertex to be similar in Prove 2 to Prove 1. That appears to be true and actually a little better in Prove 2. The lawsuit seems to be based on the fact that SOC arm of Prove 2 was 59 per cent at 36 weeks, making the Teleprevir in this 24 week study only 6 per cent more effective than SOC at 36 weeks.

I guess they were supposed to "disclose" that SOC rates were greater than 50 per cent. This, even though they were not even up to the 48 week point on SOC, much less the  6 month post point.

If they "falsified" the results they deserve to be headed to jail, but, according to what I see, is not the case at all.

Yes, we do all know they do not accept people in late stage 4 but on the other hand, as Andiamo stated, they do not allow rescue drugs either. The results are not the same as they would be in "real life". However, Teleprevir appears to work better than SOC in half the time for us GT1's and I am hoping that this drug as well as the others get here in as short a time as possible at the smallest possible cost for all of us.  

BTW I have never owned any Vertex stock or that of any of the competitors.

[jdwithhcv]

From the lofty heights of what profession do you condemn the entire legal community?  Just curious.

[mar148]

For me, I don't think poorly of attorneys, just some types of class action attorneys (not all), just need to be careful what peoples motives are.  As soon as I read something from someone named anonymous (mice) the red flag should go up.

[Andiamo1]

I agree with you; the id set me off.  I also agree that most lawyers are ethical and I don't have any criticism of the group as a whole.  I don't think that lawyers could possibly originate the suit; stockholders made the first move by hiring the lawyers.

The sad thing about posts like this is it might influence people to make a decision about Telaprevir that is not based on medical data.  

[Andiamo1]

The stock is up over 8% today!

[anonymice]

Thank you, Mike. I came to post it just in case someone here wanted to know.  

Yo Burned - how about you go blow your toxic smoke somewhere else, buddy. I don't know you from a hole in the wall.  I've been around clinics and trials and VX-950 and HCV 796 a long time and have done my homework for years.  I put the information about this Class Action suit here because I knew of many on this board who have have previously shown an interest in this drug and want to stay on top of what's happening.   I also put it here for those I knew here who were in the VX trials and for those who might come here to consider trials.  I also put it here because I know some here who did purchase shares.  Do you have something against those with Hep C who invest?    Since I didn't come here to blow smoke up your skirt or anyone else's, let me ask you something.   What the H kind of whack job are you, anyhow?   Are you always this arrogant with someone who posts an "information post" on a Hep C forum  (one that's got many people here in trials and interested in VX?)  Do you always think an attorney is out to "get someone" or that drug companies are ABOVE being held accountable ?  

Fretwhoever, you say "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."   OH - so It doesn't make sense, you say?   Oh really?  OK then  - you're free to stick your head in the hot sand with what's his name and close your eyes or open them only to see roses for the VX-950.   I'll tell you too - I didn't just jump on the Hep C treatment journey or treatment journey or trial journey wagon.  Take your condescending remarks on down the road and have a wonderful day.  

Hi Foo - hang in there.  I have no idea what it will do to the future trials. I wish you the best of luck with your treatment.  

Thank you, SusieQ2008. I'm glad you could take the information for what it's worth.  

Thank you the same,   Trish.

Thank you the same, Bobby1952.  You said that well.

Andiamo, you're feel to free paranoid but I can assure you I'm not here to "manipulate" any data.  I take that back - I'm really a spy who put this post here to make everyone paranoid.

Mar148 - go stuff your condescending remarks, too.  
.  
Everyone have a good day.

[fretboard]

It's fretboard and my apologies are in order.  thanks for the post, I learned alot.  later

[Andiamo1]

Most people that read this board are not trained doctors, scientists or lawyers.  We read the board to try and get enough information to make reasonable decisions regarding our health care.  It is extremely important that we understand the biases of the different data presented here.

Drug companies have a bias to present the data as positively as possible, since it helps get approval and eventually sell the drug when it comes to market.

Lawyers fining a class action suite have a bias to present the data as negatively as possible so that they win the suit and make a lot of money.  That said, you might get the impression that both cases are presented with an equal bias in the opposite direction.  THAT IS NOT THE CASE!!

The data presented by drug companies are analyzed by doctors and scientists.  The drug companies are liable for false data and at the least, lose a lot of money if they get caught presenting false data; at most, they lose the company and go to jail.

The data presented by lawyers are analyzed by juries that have no training and are selected by the lawyers using criteria that will try and get people that are easy to lead to a conclusion.  Only in the most extreme cases of fraudulent data would there be any downside to the lawyers for presenting misleading data.

So, I am much more inclined to favor the data presented by the drug companies.  My anecdotal information from myself, and others on the board, suggest that Telaprevir is an important new treatment for HCV.  I think it would be a shame for people to read the data from a  lawsuit and treat it with the same credibility as the data from the drug companies.

[desrt]

I think BILN2061 put the nail in the coffin for all protease inhibitors years ago. If the increase in response rate is no better than the increase in drop outs due to sx you're spinning your wheels. Prove 3 seems like a huge waste of time and resources - clapping your hands real hard trying to bring Tinkerbell back to life. It seems like the only thing Vertex has learned from earlier PI failures is what testing not to do if you want to slide your stuff past the FDA.
The answer lies with interferon and we've wasted 5 years for $ reasons when we should have pegylate Infergen by now. We should have a dosing schedule for Albuferon. We should have tried bonding Alfa 2b  with a branched  PEG molecule by now.
And, oh yeah, lying by omission is stil lying.

[Andiamo1]

Do you think any one with aids whose life has been saved by PIs would agree with you?  Do you think all of us on the board that have amazing experiences with Telaprevir make it up?  What degree in biochemistry do you have that lets you make these pronouncements with such authority?  What knowledge do you have about Telaprevir that goes beyond that of the people on the board that have taken it?

If you convince one person to not take a drug that could save their life, you have done great harm - so don't do it out of anger or misinformation.

[Tallahassee]

If you are a patient and a non-responder for a very long time, 6% increased response with new drugs versus SOC's data -- LOOKS GREAT TO  ME!!

Chears!

[Willy50]

I think that you've already been proven wrong about PI's.  While Biln 2061 showed great promise it never made it out of stage 1 trials.  On the other hand....... Vertex is now enrolling Phase 3 trials and has an impressive track record; both in regards to safety profile and efficacy.  The latest webcast that Eric mentions was VERY impressive.  Not only will they be the first PI to be approved but also (therefore) the first to likely be approved to be used in conjunction with polymerase inhibitors.  This means they could be the first all oral treatment and we may also see greater efficacy rates yet with that treatment.  Since they are now in phase 3 the concept has gone from the theoretical and has now been proven.  Phase 3 should also prove that no more than 24 weeks of treatment will be needed for most treating.

All....

On the subject of withholding information........ it feels like the topic is a bit more complicated than is conveyed.  Vertex has constaints placed upon them in several areas; not only by the shape of the blinded trials, but by the SEC, and the FDA.  Further...... Vertex indicates that the FDA is instructing them to only release information in certain venues such as AASLD.  They are therefore forced to hold information that they have and could release until certain approved events (EASL will soon be here) arrive.  Premature release of information can be regarded by the FDA as an act of "unblinding" a trial therefore possibly compromising its objectivity.  I would suggest withholding judgement.

Finally if I understand the studies correctly...... it isn't that the Vertex drug scored so low...... but that the SOC arm scored so high (50%?) that allowed them to state that there was only a 12% difference between the control arm and the triple therapy arm.  (Now who is obfucating?  : ))  This may merely prove the weakness in making assumptions based upon trial results,  The trial results maybe dramatically different that what we will see in results if and when the drug is approved.  For instance.....a person who dropped out of the trial..... but ultimately cleared still is not counted as an SVR.  So far as the trial is concerned they are a treatment failure.  So far as most of us are concerned..... if they SVR and in a short period of time it's a tremendous success.  It's a question of perspective.  It also clearly shows how numbers and stats can be used to "lie".  Please be careful of making premature assumptions.

I would close by mentioning that right before the fall AASLD Sherring-Plough "leaked" a bit of information about the response rates of their drug Boceprevir.  Vertex stock plummeted.  I will note that once agin.....right before another important drug conference (EASL) there appears yet another news story which may or may not have substance but could impact on the perceived value of the stock.  I sometimes wonder about who is guilty of manipulating stock prices.....  It's all over my head but it could also be a goliath drug company trying to financially rack a company in the lead and make it more difficult to get their drug to market.  It could also be others trying to depress the stock price so that it can be bought up at bargain prices.  Oooops; that may have just happened just in the last week.

It's an interesting stock and process.  Try to remain calm people.....

best,
Willy

[moahunter]

I really think no-one knows one way or the other right now if the benefits of these drugs will outweigh the additional toxicity / side effects. It may even turn out that they are only used eventually for those who have failed SOC. Why take something more noxious, if the less noxious beast may do the trick first (and yes, I know that depends on whether treatment can be shortened, but that is highly questionable right now). I really do hope these drugs succeed, but I also truly believe that people who have not tried, and are postponing SOC in the hope of a medical mircle, may be making a mistake. Seems to me that there is enough doubt right now, and have been enough controversies with drugs being approved too early, to suggest that the wait could be quite a while.

[nygirl7]

Honestly aside from Andiamo I don't remember anybody who did that well on the Vertex - I do remember all the people who had to drop out because of the rash though. That is an interesting point to see if we can remember them.

I don't think there was anything wrong with Mice posting this article. In fact it's interesting and really doesn't say anything bad about the drug it's more about the fact that people are always going to look for a way to get some cash. In fact If I read this I'd probably have posted it as a story of interest myself.  I don't think he/she(?) was being in any way meanspirited it was just news about a trial drug with some fishy things going on.

I always though that a while back we were given some reason why the Prove 2 arm had problems and that data wasn't valid.  I wish I knew how to look back in our threads because I know it was discussed already.

Seeing as I think it was.........I don't think being rude to this person is really representative of a group of normally nice and decent people.

Back to my original question.....................aside from Andiamo who just got his UND - who SVRd on Vertex that we know?  I'm curious now. an awful lot of people were on it but  i just can't remember the success stories. although as Andi said - for even one person to be saved is a true miracle - I just want to remember if we had any others         Debby

[Andiamo1]

I hope I was not rude to anyone, but it makes me angry to see people present their opinion as if it is fact. I agree that it was a good thing for anonymouse to post this and start the discussion.

As far as I know, all but one person on triple therapy had the same results as I did.  There are no serious toxic sides other than the rash over and above those of pegasys;  even mremeet that had the rash and had to drop out still reached SVR.

I am very puzzled by all the negative press here.  The research coordinator at Mt Sinai said that including dropouts, 80% reached RVR and 95% of RVR achieves SVR if they do not drop out at a later date.  Read the warning labels on Pegasys and tell me that Telaprevir adds anything significant to the mix.  A 50% reduction in treatment time when taking anything as bad as Pegasys is very significant.  In fact, the only really bad side effect I experiences was a retinal hemorrhage from interferon.

Again, I think anyone that wants to advise people not to take a new and powerful drug, should become an expert on the data before they make a recommendation.

[Forseegood]

sometimes people who get disagreed with, sometimes become disagreeable....I don't think there was anything "wrong" with the article being posted, just like I don't think there was anything wrong with people presenting THEIR views about it...negative or positive...but then I put it down to some people being on strong drugs or whatever, and they get negatively triggered very easily...anyone who puts an article on here should be prepared to have people talk about it, and I wish people wouldn't get so personal in their views about an "article" after all....those who put it up, and those who analyze it...I think Andiamo was trying to be reasonable, if you go back and read this thread...

Nygirl: sweetie, most of those people who came on here on the trials svred...unless I'm wrong about something, it was just a few who didn't....Susan didn't but she didn't get a 3 prong treatment....

[Willy50]

As mentioned by Andiamo.... the exposure to a drug can me measured both by quantity of drug taken AND also by duration.  The Phase 3 trials are constructed to "Prove" a few things;

1)  That a treatment course of 48 weeks will no longer be required for most genotype 1's.
2)  The outcomes when one treats with only 8 weeks of triple therapy versus 12 weeks of triple therapy (followed by 16 and 12 weeks respectively of SOC).  IF one responds VERY quickly you may face a shorter course of triple therapy (8 weeks may be enough for some groups)
3)  There is mounting evidence that one may soon be able to assess outcome of treatment in a shorter time period.  This will also reduce unnecessary undo exposure to TX.

IF Vertex is to succeed it may also bode well for people whose exposure to chemotherapy is increased beyond 48 weeks such as for cirrhotics or slow responders.  One might also look to Andiamo's experience as yet another way.  I believe that this was his 6th or 7th "tour" of treatment.  Eric was able to clear with telaprevir and has remained so.  His chances of acheiving a SVR are quite good.  This is a treatment that can potentially cure many past treatment failures or other currently untreatable populations.

My point is that a stronger more effective treatment could possible reduce exposure to not only SOC drugs, but also to any required "rescue" drugs.  

It is still too early to call this all "fact" but the promise of Vertex and many other new compounds bodes very well for many of us.  While I think it is reasonable for Moahunter to be wary of unproven compounds; we really won't know until truely large groups do this treatment.  It still looks VERY encouraging and there IS a LOT of positive existing data.  I have a little theory that until better treatments arrive we may not see or have data that compares just what some of our current chemotherapy courses of treatment do to some people.  I feel that shorter courses of treatment will be very beneficial to everyone.

best,
Willy

[Trish77]

Forseegood:  If you go back and read the thread, anonymice's motives were questioned - rather strongly too, his/her legitimacy was questioned and the choice of nickname was deemed suspicious.  I think it DID get personal and it does happen on here sometimes.  Been there, done that myself unfortunately.  And I think with various people involved in the Telaprevir trials and having put alot on the line themselves AND with people holding out much hope for the results, it can hit a little too close to home perhaps.

I personally don't think there was anything wrong with that post.  Anonymice had a concern, expressed it AND asked for information that anyone else might know.  Seemed fair enough.  The concern can be addressed without it getting personal.  Again...been there, done that unfortunately .. so I know how that can happen.  Just saying, is all.

Trish

[Forseegood]

I think youre agreeing with me, lol....I just think it got too personal on "both" sides of the argument, unfortunately...I think it sparked a lively debate with many good points on both sides, unfortunately, some people get too carried away...I've had bad days myself as well...

[moahunter]

"As far as I know, all but one person on triple therapy had the same results as I did.  There are no serious toxic sides other than the rash over and above those of pegasys;  even mremeet that had the rash and had to drop out still reached SVR."

Doctors are only now beginning to fully understand all the implications and side effects of interferon and riabarvirin. I think it is a pretty big statement to say there are no serious side effects - we just don't know that yet. For all we know, this treatment might limit future treatments, it might result in some type of disease in the future (vioux jumps to mind), or, it may just be untolerable to so many people, that the  benefits outweight the advantages.

As said, I don't think the answers is just around the corner, as some have been suggesting on these threads. I hope this, or something like it, is approved soon, to give more options to those who have not responded, but as it stands, there is neither an assurance of anything being approved soon, or an assurance that what is to come will be more pleasent than what many of us have gone through.

[moahunter]

probably should have read "downsides outweigh the benfits" :-) Anyway, hope we get new treatments soon, but people, especially those who have not tried the current options, need to be realistic as well, and maybe spend four weeks of their life to find out if they might be RVR on the current, well known, fewer drug, treatment regime.

[spcecst2]

Ditto what you said!!!!!!!!!!!!!!!!!!!!!!!!!! I have no doubt that big pharmaceuticals play games, there's to much money involved for it not to happen, thats the world we live in, I for one will never tell anyone who has this **** in their blood not to try anything that may give them svr, no matter what the percentage!!!!!!!!!!!!!!!!!!! And lets not forget one thing, lawyers in class action lawsuits make big money and the people they pretend to be helping make sh**TTTTTTTTTTT. They made big money suing for implants that are back on the market today, they made big money suing tobacco companies for cigs we all smoked with warnings all over them!!!!!!!!!!!!! The only thing class action lawsuits mean is some frickin sc*m bag lawyer or law firm is making money!!!!!!!!!!!!!!!!!!!

[jdwithhcv]

Again I ask, from the lofty heights of what professions do you guys condemn the legal community?  Burned is silent on that point, how about you spcecst?

[spcecst2]

From my personnel experience dealing with lawyers!! Does anyone really think that all these bul sh*t lawsuits (where the lawyers get the most money) for millions of dollars do not hurt this society and economy! Get real there are thousands of cases with millions paid out that should have never seen a court room! Try and go to one of those ambulance chasers that advertise “for the people” and tell them your problem, if they don’t think they can get a quick settlement (which happens to much in this country cause the companies, even if they are not negligent, settle because they can’t afford the battle, and the chance that they’ll get a jury of morons who rule for the plaintiff) or the company you need to sue doesn’t have deep enough pockets, your just wasting their time!

You want personnel experience:

Wife who is totally disabled applies for SSDI, of course she gets turned down twice cause we don’t have lawyer no matter how much evidence we submit, so we have to get lawyer, who we give evidence we submitted previously, he submits said evidence request hearing with judge, lawyer shows up two hours late for hearing, says judge she is disabled, judge says your right, when retroactive check comes it is minus 25% for lawyer and you don’t get to negotiate that cause that’s what SS and lawyers have worked out, and I pay tax on it! Lawyer says se ya later disabled lady have a good life! Not bad for letter and two hours late!

Wife falls in puddle of water (in store) 8 months pregnant and we get lawyer who tells us hey if you give me this much in cash in parking lot we can settle and beat the standard 30% I would charge. Cause he didn't want to put in the time!

Have to hire lawyer to write letter to big bank to remove lien that was mistakenly placed on real estate, lawyer says I’ll write letter, you write check for 1000.00 dollars! He writes letter they remove lien! Yes I got the money back, but what about someone who didn’t have the 1000.00 up front! Sorrrrrrrrrrrrry!

I get in acccident, not my fault even if they lied, insurance company settles just so they don't have to put up with the cr##p! Who do think pays for that loss? We all do!!

And so many stories (where I have first hand knowledge, not hearsay) of people who couldn’t get lawyers to represent them cause there wasn’t enough money to be made!

Yes there are companies who deserve to be sued and sued hard, but lawyers have a racket! If you are a lawyer and a good one then it’s to bad you have so many who are not!

People who complain about jobs going over seas or the cost of products, services etc… and don’t believe that lawsuits that are filed just to make money no matter how dumb need to be on “THE YELLOW BRICK ROAD”!!!!!!!!!!!! You don’t have to have any personnel responsibility in this country cause if the is any money to made for the lawyer they’’ sue!!!!

I would vote for Jessie Jackson if he promised tort reform in this country! Did I just say that!!!

Yes I condemn the legal community!!!!!!!!!!!! And yes I condemn the business community!!!!!!!!!!!!!!!!! But people who have nothing but pain and misery end up with pain and misery and lawyers end up with big fat paychecks!!!!!!!!!!!! Yes I know there are good ones!!!!!!!!!!!!

My lofty heights are from working 40 to 50 hours a week for 28 years trying to survive and not leaching off of someone else’s poor misfortunes like so many fine attorneys of law!!!! Oh and let me say I have served on many juries, of which most attorneys on both sides were big losers, and I was saying my prayers that I wasn’t born as dumb as some of the jurors on the jury with me!! It was scary!! Jury pools are a joke!! Served on Civil and Criminal including murder!! Judges should be held liable for letting some of these cases go forward! Wait that won't happen cause their lawyers! Some of the laws should be changed to stop some of these cases from going forward! Wait that won't happen cause most of the law makers are lawyer! Wow we are stuck!!!!!!!!!!!!!!

Don't get me wrong I've been over the pond and seen those legal systems and I don't want to have those but we shouldn't have to settle for what we have! And it should be easier for the people who don't have the money or big money case to represent them selves! And not just in small claims! (I've done that too, and man did I **** off that judge but I won!)

Try and get lawyer to go after a lawyer! You'd be better off kicking a pit bull!!!!!!!!!!!!!

Wow!!!!!!!!!!!!!!!!!!!!!!!!!! Just my thought's!!!!!!!!
I still love ya'll!!!!!!!!!!!!!!!!!!!!!!!!

[spcecst2]

I wouldn't be surprissed to see some lawyer bring a case for Carpal tunnel cause someone surfed the net to much looking at porn!!

[Andiamo1]

You are correct; I should not make blanket statements about SX of Telaprevir while it is still in trials and not that many people have taken it.

I do need to point out that interferon at this point in its development had many more serious SX identified, so it is not out of the realm of possibility that Telaprevir will have fewer side effects than interferon.

We might all wait for the Vertex presentation in two weeks at EASL.  I think there will be considerably more data available from the people in Prove 3 in the 24 week arms.  I just completed the 48 week arm and I was one of the first people to start.  Over the next few weeks, many more people will complete the 48 weeks and significantly more data will be available.

[Deb_c430]

To be honest, I have not been tracking this because I am not in any of these studies.

I would like to comment tho on some of the most impassioned statement made, concerning lawyers.

I have found that as im most professions there are good and bad.  It also seems to me that Americans are sue happy,  that greed seems a crooked lawyer, Doctor or any other professionals best weapon, we provide that tool.

I have never minded paying someone for their education, for the ability to get done what I couldn't.  I could never cure myself with out the help of researchers, drug comapnies, Doctors et all.

Take class action suits, I see them advertised all the time on tv,  sometimes I think ok, how many will call on that? Greed.

But then take the water situation here that Erin Brokavitch a movie, that was real, with out her and lawyers like her,  these comapnies would still be happily filling their pockets!

Take the drug given to women for morning sickness in the 50's,  with out class action,  their children would still be lost.

So while I may agree there are many bad lawyers, Doctors, Insurance companies, Ceos, I think   that generalizing is very dangerous.


Just my thoughts

Deb

[desrt]

I don't lay claim to any degree more prestigious than a high school diploma. I'm just a guy that turns a wrench and spends too much time on the internet.
If you go back and read my post - and almost all my posts for the last two years - I use the phrases,
"It would appear ..."
"It seems..."
"I think ..."
"In my opinion..."
more than most who post here. I deliberately distance myself from the type of pontifications that many self-important, self-appointed HCV gurus here indulge in.
My opinion that VX950 side effects are on a par with its value added to SOC, are just that - my opinion based on what I've read here and elsewhere. The same goes for my opinion that the money spent developing drug cocktails for HCV would be better spent improving our knowledge of IFN and its delivery systems.
As for my influencing anybody to change their course of treatment, if anybody can get past the MedHelp disclaimer and takes the advice of someone who uses Foamy The Squirrel for an avatar, we'll just have to write it off to natural selection.

[Forseegood]

too bad I haven't smoked weed in over 20 years, cause you'd be an excellent person to get high with, youre a trip!!! and I mean that in a good way! lol....

[Isobella]

Have y'all seen the "spin off" thread on this?  Some of the comments sound...paranoid may be a good word.

That being said-I want to thank everyone for their input on this subject.  I am one that is waiting to begin the next phase and have learned (once again) so much from reading what everyone has to say.  Knowledge is power and all that!!

Best to all-Izzy

[spcecst2]

I need that right about now! And it would be a trip! Fun trip!!!!!!!!!!!!!!!!!!!

[Isobella]

....and immediately I feel bad for saying some comments on the "spin off" thread sound paraniod-sorry-I don't wish to offend, just making an observation.

Izzy

[Andiamo1]

You have always seemed like a reasonable person that thinks through what you say.

I still think that interferon is one of the most dangerous drugs on the market and the less you take it the better.  So, I don't agree with you, but I have taken interferon longer than most anyone on this board, so I am prejudiced.

As for influencing people - all of us make decisions based on objective and subjective reasoning.  That holds true no matter how smart or well educated we are.  When opinions are expressed with a strong and confident manner, people are influenced whether they are smart or not - educated or not.

[spcecst2]

It's all good!!!!!!!!!!!!!!!!!!!!!!!! We're all in this together!!!!!!!!!!!!!!!!!!!!!!!!!!

[anonymice]

Fretboard,  thanks for your apology. Much appreciated.  Miked and anyone else who's interested in reading the charges and complaint,  here:   http://tinyurl.com/32ayvx.   For those who can't deal with reading the civil action, just don't read it would be my suggestion, or - if you want to shout at someone about greedy law firms throughout the US and abroad who are representing shareholders i.e. those who made it financially possible for VRTX to continue manufacturing their "block busting" Telepravir to treat Hep C and who might get a quarter back back on every 1000. they lost NOT because SP or Roche or Wyeth or any other pharm is being named in this suit but because VRTX is)  maybe you'll have the guts to pick up your phone and call those law firms and protest as loudly there as you do here.  I'm sure they'll take your opinion for what it's worth.

To Burned and Mr.Andio whatever and Mars whatever or whoever else got "personal" and who got "set off" because of my ID, that's your problem.  If someone with Hep C is reading from a support forum and is looking for information on treatment and considering what their options are  (and that is the case on this forum), and they happen to be gullible (or desperate, as is the case with many with Hep C who are afraid they are going to die)  to the point they believe that pharms and their sponsors never withhold unfavorable facts and never tell a lie and never scheme to make intentionally false and misleading statements,  then that's your problem, too.  Hopefully persons with Hep C who aren't as gullible as you appear to be will take the time to read the complaint and take some things into account.  Here's a suggestion to you three  (or however many there are now who are "paranoid" I'm representing some stock board) - get out of that little Tinker Toy box you're playing in and consider that not all subjects who enroll in trials and/or treated with VX got favorable results and that there was nothing "suspicious" about my note to begin with and that the information I put here about the civil action against VRTX needs to be here whether you like it or not.    

The initial post by me on the class action suit being filed against VX is not here because I'm someone from a Yahoo stock forum.   It was posted by me because I have HCV and used to read a lot from these boards in 2005, 2006, and 2007  (participated too.)    As my initial note states,  I came by MH when I got the news alert to see if anyone here was discussing it.   I found it odd  (considering the 100s of notes that used to be posted on VX here)  that it seemed no one even knew about it.

Stop smoking bad weed - it makes you way too paranoid.

Warm regards,
Mickey The Mouse,
Stockbroker Of Mice and Men

[Forseegood]

hey, chill a little bit guy! not all of us are suspecting you...I think what's going on is a lot of new people on here...and boards get to be gathering places, etc...we are all in this together...maybe not all of us would marry each other...but we certainly all have something in common, and we can get along...you seem like an interesting, smart guy...hope youre well....

[spcecst2]

If you find an investment opportunity that doesn't have a risk of losing money please come back and share with us!

[anonymice]

Thanks FSG :)   I hope you're doing well these days.   In the rush of coming by here last week and today, I was reading the responses quickly.  For my failure to not thank those who were not suspecting - my bad.  I thank you all now.

You guys have fun and be well!  

P.S.  Yo Space - I'll be sending my shareholders their portfolios this week on the hydroponic farm I purchased from Proctor and Gamble last year . It's doing great!   We're going to be voting on the name

1)   "Smokey and Chilli Out"
2)   "Hydro & Nutso Fibrotic Farm"
3)   "Grow & Toke"

Warm Regards,
Doing Mickey's Monkey :-)

[Willy50]

Speaking of feeling paranoid......

Hey, I think it's great that you posted the article.  There are several lawfirms doing the class action and the news has been out for about a week or a bit more.  So far as I'm concerned it's all news and its about HCV and so fair game.  Obviously, many people are interested.

I think you are getting some heat because you are acting a little reactive, I mean..... I'm not smoking any weed; just looking to balance out the "story" a little.  People have a tendency to buy into the drama or take things at face value without any inquiry.

Take that date in the article you posted; November 2.  Do you know why they "disclosed" that day?  It was a presentation at the AASLD (doh!!).  Do you know why they "disclosed" it there and then?  Under the direction of the guidelines issued by the FDA.  Vertex is not to use data to help sell their product (such as in pitches to investment groups.  It appears to me that Vertex was playing by the rules when they used the liver conference to release information about the trial data.

And then.....OMG!!!!!  The stock dropped like a rock after they....those villians....."disclosed".

What the article does not say...... nor does the lawfirm convey.......that the stock had been slipping for weeks. (check it out, eh?)

And why was the stock price dropping?  One reason was that Sherring-Plough made an announcement about the success of Boceprevir about one week before the liver conference; look it up.  They gave comparable efficacy data and reported that there were no rash issues.  They also provided precious little data about the construction of their trials, RVR rates, and meaningful data which would have allowed comparison.  Their announcement basically served as a spoiler and was also regarded as a great surprise to the investment community.  

At the AASLD there were other such surprises.  Many new compounds were showing great promise.  Wall street in effect figured that there was only so much market; if they were to be successful then they would have to share in the profits.  For that reason it was reckoned that Vertex, even if succesful might end up with a smaller market share ....or a shorter reign....and therefore was downgraded.

One final kick in the teeth was the Romark/Alinia product NTZ .  This was another dark horse which surprised everybody with a low cost and seemingly effective treatment.....with a drug that was ALREADY approved; uh oh......

I understand that it will be the job of the legals to "sell" the idea that the stock dropped due to some chicanery on Vertex's part...... but I am not making any of this up.  Clearly the stock price was affected by a number of issues; the least of which may have been their release of data on what still seems to be an effective compound.  

This is just the issue as I see it.  I look forward to seeing the evidence as it comes out.  The Bear Sterns caper seems to have more of a scent of bad herring to me......  : )

Best,
Willy

[mar148]

Well I don't come here for a stock broker or an attorney.  I have other resources for that.  It seems wrong to use a medical help site for either.

[Andiamo1]

Sorry for making fun of your name.  I think you posted the original article in good faith and much of the discussion was valuable.  I am not sure where all this anger is from.  Perhaps it is due to the fact that so many of us have gone through 48 weeks of Pegasys and we are all stressed.

Willy is the voice of reason here while the rest of us seem to have entered the vortex.  I am dropping off this thread and going back to posting sailing stories.

[mar148]

I would be happy to be wrong about my concerns about people's motives in this regard.  I too and moving on to other things.

[anonymice]

Hi Willy!    It's always good to see your face and read your notes.   I'm not smoking weed either -lol  (what's that song about never smoking weed with Willie again?)   Yeah, I agree - I was "reactive".  I remember well listening to the 2006 and 2007 AASLD teleconferences and reading the financial reports and all the data from the conferences (read read read read discuss discuss discuss discuss)  VX, SCH, and then comes HCV 796 (phase II pulled by the FDA.)    Lots of competition!  

Must run for now!   Thanks for the balance and your level-headedness.

And oh - If you didn't see it  (the complaint)  

http://tinyurl.com/32ayvx

It's odd seeing the ones I considered "the Gods" of the "new PI"  for Hep C listed as "defendants".   I hope after all is said and done, they'll have a better treatment for HCV in not too many years from now  (and a kinder one.)  

Later - have a great one!  Be well.  

[anonymice]

Thanks for the apology, Andiamo1.  I'm sorry for getting angry, myself (or sorry for sounding so angry.)   hmmm....  HCV, combo, relapses, nonresponders, doctors, drug resistance, class action lawsuits, anger???   (You know not!  :)  

Sailing is good stuff!   Great stuff!  

Wishing you well and the best.

[Mary4now]

Wow, too much to read, so synopsis please.  I am waiting to treat g1 stage 1 and how do I monitor how these new drugs are doing and when and where the trials are.  Sounds reasonable that I would want to wait for a shortened Tx, w/ less sides.   Wow you all are amazingly articulate and detailed thinking...

[merryBe]

there was plenty of chatter back when the news that they botched the numbers first came out....the whole study was maybe getting thrown out...

with 10 companies all viaing for the billions the next new drug will make...it's no surprise there will be more scutiny which is good really...

I mean..what if we take one mre poison that gives us 5 percent better odds only??

Tallahassee??  If we are talking MORE crawling skin that I want to rip off my body each night....then I'll skip that 5 percent.
better to take some ANTIfibrotics that do no harm...and may help fight VL then something that will tare you up...for no better odds.
Just my take.

the way I remember this is fuzzy didn't they screw up the numbers so bad it was like....thought someone went brain dead.....and how do you "prove" something like that is deliberate.  

the number a sckewed anyway....for instance, many studies disclose they had a certain drop out rate...but that rate is not included in the final stats....maybe they think it's irrelavant, since they did not make it through due to sides..no way of stating the ever SVR'd.//        However obviously leaving those folks out of the final addition can leave one with numbers twice as good as they really are.....and it's done everyday...
you kind of have to learn to read into the study stats what they are not telling you...
it's not "REALLY criminal".....yet it does tint towards the rosy doen't it.

good luck on getting money back for drug company screw ups.....
stockholders pay always, and lawyers only get rich on these class actions.

[Willy50]

No worries and nice to meet you.  Although these threads can sometimes get contentious at times when I look back at some of my favorites it is often these threads that I enjoy the most.  A little back and forth can be fun and often when there is some disagreement the other side digs a little harder.  You can tell from the number of replies there is a high level of interest in this subject.  For me, I sometimes like to be able to play devils advocate and this thread has allowed me that......and perhaps the opportunity to pitch a few points myself that most people are unaware of.  Nice to meet you and perhaps I owe you a thanks for posting the article.  We'll see how it all shakes out.  It kind of reminds me of a lawsuit in which they have to designate a percentage of blame to the defendant.  In this case it would appear that there could be numerous other co-factors involved in the drop in stock price.  One rather large factor previously unmentioned has been the general financial outlook of our economy.  It will be interesting (and probably incredibly tedious as well) to see how they arrive at some sense of justice on this case.

Although there have been many comments in this thread and it's not possible to address them all one I would like to comment on is the notion that the numbers in a study can be skewed to present a more favorable outcome.  That is most certainly so...... but I am of the opinion that that these trials seemed to me to be run pretty objectively.  One must have certain criteria which rejects some trial applicants.  IF a trial would risk a persons life it seems sensible to exclude them.  IF the outcomes were clouded due to peoples other medical conditions it would also seem reasonable to exclude them as well.  Over all the trials were inclusive; although the early ones were limited to genotype 1's there were all ranges of liver damage admitted.  In Prove 3, the trial for past treatment failures they admitted all types of past treatment failures; relapsers, non-responders, breakthroughs and patients who had to stop TX either from their or their doctors decision.  

We also saw that Vertex did not allow "rescue drugs". Sherring-Plough DID allow the use of Procrit I think to keep people in their trial and on fuller dosage.  Why would Vertex do this when Sherring did not?  They were after uncompromised data.  Vertex no doubt knew that IF they allowed for example Procrit that the success rates would look better, but they opted instead for a more pure source of data in spite of the fact that it would make their outcomes look less robust.  In the end..... it might be argued that their stock price dropped through their own insistence at operating a trial without the smoke and mirrors that other companies have used during trials.  Their refusal to share information with stock companies except in the venues favored by the FDA cost them some investment dollars.  Ultimately...... it may mean for us....people with HCV, a better run trial and a smoother path towards approval.  This ultimately could benefit us since a poorly designed or compromised trial could mean delays in FDA approval.

Rather than higher scores the trials have provided an aggregate of scores that will need to be interpreted by the FDA.  It's interesting to note that the Prove 2 SVR rates were better than the Prove 1 rates, but my understanding is that the Europeans...... being generally healthier, often score higher than their North American counterparts.  

There are several dynamics at hand which will affect the trial results.  Since the trial started there may be greater emphasis on greater compliance.  People know that if they can hang on and stay on full dose....particularly in the early trial that they stand a great chance of SVR.  I personally believe that the SVR rates could go up a bit more if due to fewer dropouts, greater compliance, or a change in how they count the results.  My understanding is that any dropout is a number lost to the study; even if they were to SVR.  It is possible that rather than the numbers being artificially high, the numbers have not reflected the actual potential of the compound.  Only time will tell.  

It will be interesting to hear the Vertex results at EASL, as well as the many other competing coumpounds in trials.  

best,
Willy

[anonymice]

Hi Willie (and others).  I've got only a second on-line right now.   I read your note very quick, but .....oh yes indeedy  - do I ever remember the "rescue drugs"  (or VX not allowing them and SCH allowing them and how I wound up being so very glad everyone here was talking about "RESCUE DRUGS RESCUE DRUGS - you HAVE to have RESCUE DRUGS!!" .  If I get time to get back on-line later, maybe I'll bend your ear about how thrilled I was when my hep doc told me last year that HCV 796 DID allow rescue drugs!   Trials -.....they can make a body tired :)

Later!  :)  Got many clothes to fold!  

[moahunter]

I realize that many people have benefited from rescue drugs, by I did not use them (aside from a sleeping pill), and if you do not need to, many would prefer not to. My preference for the trials is that rescue drugs are not used, as it would seem to me, to "taint" the outcome, who knows what interactions they may or may not cause. Additionally, if we mask the side effects, how can we honestly compare the value of new drugs? All I know is that I suspect we will be waiting quite a while for the answers, I would be shocked if any of these drugs is approved in the next 5 years (except perhaps for limited circumstances) just based on the amount of "discussion" they generate on these boards alone. I also think that maybe more research should be done on the disease itself, looking for a fundamentally better treatment, rather than more "get rich  quick add ons". As it is, many are afraid of treatment due to toxicity concerns, added more drugs, even if shortening the treatment time, may just add to those fears, and drop out rates.

[Andiamo1]

And thank you for the apology as well.  

I don't know what is happening to me.  I completed treatment a week ago and feel like I am on speed.  I have more energy than I did for many years.  All this is a good thing, but it makes my more argumentative than usual.

Yes sailing is great.  Do you sail?

eric

[Andiamo1]

Schering-Plough(SGP - Cramer's Take - Stockpickr) may not be the formidable competitor to Vertex Pharmaceuticals(VRTX - Cramer's Take - Stockpickr) as previously thought, according to clinical data released Monday on their respective hepatitis C drugs.

The new clinical data, released in advance of next month's European liver disease meeting, pushed Vertex shares up almost 18% to $21.96 in recent trading.

Also aiding Vertex on Monday was new clinical data of its own showing that its drug telaprevir was effective in hepatitis C patients who cannot be treated with currently prescribed drugs.

Schering-Plough's experimental hepatitis C drug boceprevir given in combination with pegylated interferon and ribavirin pushed the virus below detectable levels in 38% of newly diagnosed patients after four weeks of treatment, according to new data from a phase II study released Monday.

In another group of patients who were pretreated with interferon and ribavirin before receiving boceprevir, 62% of patients achieved undetectable viral loads after four weeks.

This antiviral response at four weeks is known as a rapid virologic response, or RVR. It's widely believed that a vast majority of hepatitis C patients who achieve an RVR at four weeks will go on to be fully cured of their disease once a full course of treatment is completed.

This boceprevir data is not a robust as similar results previously presented by Vertex's hepatitis C drug telaprevir. In two phase II studies, 79% and 75% patients given telaprevir achieved so-called rapid virologic in two phase II studies.

[littleswim]

All I can say is that I am grateful to Vertex and their drug, I do NOT believe for one second that Telaprevir will fail or that it is "over-hyped". I failed 96 total weeks of SOC and after 25 years of infection and severe scarring, this drug has finally done the trick and cured me. We need to look beyond the stock price and to who the real victims are here; those are the patients infected who will one day face death or a transplant because we would rather crucify a company for being excited about its trials. No one should die from being a victim of red tape.

[Andiamo1]

I agree with you 100%.  I aargued repeatedly here that Vertex has done their best to produce a great new drug.  Many people in spite of overwhelming evidence to the contrary, insist the trials are rigged.

[littleswim]

If Vertex can cure me it can cure anyone. A huge problem with the PROVE trials is patient compliance, it was constantly stressed that taking the medicine every 8 hours was cucial to success. It took daily phone calls and reminder emails from my husband while I was at work and alarms all over our condo to keep me up to speed. This worked though, as I had never gone below 114K viral load on SOC and I fell from 14 million to 0 in 10 days on this stuff and have been there ever since. Those of you suing the company should hope you never need the help of an experimental drug to save your life; no matter how much money you milk Vertex for there is still no way your money can buy health.

[Forseegood]

I'm soooo glad of your success, after that long of trying with soc... and I'm sure your giving many hope when they didn't have much...good on you!!!!!

[Jacob43]

Not planning to treat for awhile but how many of you were involved in trials that are still presently here and how are you doing

[dointime]

I was in the PROVE2 trial and drew the no riba group.  I did not SVR.

I do have an issue with the trial, which is that it was never explained to me about the possible consequences re. that I might develop resistance to telaprevir if I got the drug and failed to SVR.  I accepted from the outset that the trial tx might fail, but I did not know that it was my one and only shot with telaprevir.  If I had been informed of that I don't think I would have done the trial.  Furthermore, it has been explained by HR on this forum that any experienced virologist would have known about the danger of developing resistance, from the history of the development of HIV antivirals.

Trial recruits are supposed to give 'informed' consent and to be informed by the study doc.  So there was definitely pertinent negative information witheld from me.  I find it a sad comment on this society that people can sue because they allegedly lost money by information being witheld but not because they may have lost their chance at a cure and in theory their fight for life.  The no-riba groups were an out-and-out scandal but it seems that anything goes as far as trial participants' rights.    

As for the posting of this thread, I'm all for making information public.  As far as I can make out, most folk with hepC try their best to make informed choices with insufficient information to go on and there's no need to perpetuate that by suppressing what information there is.  Thanks for posting, anonymice.

It pains me to write this because I know how important it is to have hope and how depressing it is when seemingly disappointing news comes out.  But the other side of that is the kind of blind optimism which got me into a train wreck.  I hope Vertex gets approval and gets telaprevir on to the shelves pronto because it obviously works.  That doesn't mean that we should ignore the trail of wreckage it left behind on the way.  There are many more drugs and many more trials to come.  Hopefully lessons can be learned which will add up to less people getting hurt in future trials.    

dointime    

[merryBe]

I remember a huge scuttle butt about Vertex skewing numbers last year. Guess we all thought it got resolved but maybe not.

It could be the reduction in percentage is due to a tighter control in phase 2.
I mean, since they had so much trouble with cryopenia they may have lowered the dosing across the board, and hence gotten less results. (Of course if rescue drugs were allowed, then the greater dosages and hence results might follow.

In any case, the way they garbled their numbers I'm not sure anyone would know which ones to believe.
Maybe it's just important to know some of us will get something that might help...even if it does only turn out to give a 5 percent bump.
Like with HIV 12 drugs equally 20 extra years.....we'll take whatever we can get!
Of course, if I counted a penny for every time a stock I owned had doctored their numbers I could take you all to lunch!!
mb

[lynnie950]

You mentioned you were UND at week 2 and week 12, by taking  vx950 and ribivirin and Peg.  I was wondering the outcome when you were checked at wk 24. Cured or not.  
I finished my treatment on dec 4th. I was UND at wk 2 and also at wk 12.  At wk 24 doc called me to say stop treatments.  I was still UND.On dec 4th i took my last dose of ribivirin and peg. The doc drew blood that day.  I go back on Jan 5th to draw blood again. This will really tell the tale, since I have not had any drugs in my system for a month.
Please get back to me and let me know how you are doing. I will also let you know how I am doing.  I am praying for you and my family has prayed a lot for me.  I am grateful for that.









vx

[zazza]

Miked is SVR. Hope you will be too.

[jmjm530]

In case anyone missed it, this thread is almost a year old. I do remember something about a suit last year, but parent why things are been resolved at least in the sense that the new trial results are very promising, then that the stock has done quite well this past year. In fact, if I remember correctly,Vertex was a number one performing stock in 2008 in the Nasdaq. Granted, not a great year for the NASDAQ :) but still Vertex was number 1, up up I think somewhere around 30%.

-- Jim

[jmjm530]

sorry folks for some mumble jumble lately, but I'm using voice recognition software to rest my tendinitis, and like my ex-girlfriend the software often just doesn't want to listen to me LOL

[copyman]

My personal experience with the stock is that it is making me money so far. The day after seeing my UNDE 3 week pcr i purchased $5000 worth of vertex stock. Today a month later that stock is worth $7300 at $30 per share. I can see that stock easily hitting the $50-100 per share price when Telaprevir gets FDA approval. I look at it this way, I'm a paid lab rat :-)

[copyman]

forgot to mention that I had never bought stock before and probably never will again. Just figured I would take a chance seeing how this drug worked for me.  There is no better way for someone to get information on a new drug then to do it themselves.

[Andiamo1]

I also bought the stock when I saw the results. So far, I am only aware of one person that did not SVR with triple therapy.

[miked]

Hi guys,

Sorry I haven't been around for awhile.

At 48 weeks after stopping tx I was still UND and thus cured.  

miked

[thegypsy9164]

I am going to "keep it simple" as most of us are not sufficiently schooled medically to undersand all of the technical terms used in these Hep C forums.  I do appreciate all of your comments, both positive and negative toward the drug company/companies and lawyers.  Taken all together, it is informative, educational and therefore, positive/meaningful.
I am presently in phase 2 clinical trials taking pegasys, ribaviren and the telepravir.  Of course I do not know whether I am getting telepravir or a placebo at this time.  Time and blood tests will tell.  I am hopeful that I am getting all 3 of the study drugs.  My Viral load count was 11,200,000 when I began on January 9, 2009.  I was taken off the combination therapy after 6-months the first time (several years ago) because I got too sick and never zero'd out.
I started this study informed by my physician of the up's and down's pros and cons.  Nobody lied to me (hopefully) and I trust my doctor.  I would think he is in the business of saving lives, not hurting people (Liver Specialist of Texas, Houston).  Anyone who has Hep C has hope for a cure, not unlike others with a disease that will eventually kill.  I would ask that we all tweak our correspondence by sticking with facts as opposed to speculation and irrational fears.  Anyone who has been on the treatment for Hep C is aware of the varied side effects and differing degrees of their effects.  It is very hard for some of us and others have it pretty easy.  Let's keep asking questions and talking about it.  We need that support (and the information is useful too).
It appears that many of us in this forum are friends of Bill W, Doctor Bob and the other fellowship.  I wish us all success in our journey to find a cure.------Joey J.

[miked]

Sorry for the delay.  Now that I'm SVR I don't come here every day.

Your stats sound promising.  I was UND between week 1-2, at weeks 12 and 24.  Today I'm about 15 months post tx and still UND.  I predict the same for you.

Cheers,

miked

[thegypsy9164]

So UND means Undetectable viral load, and SVR means Sustained Viral Response as in continued undetectable?