Just Spoke To Vertex

[Magnum]

I have a contact at Vertex. We spoke at length about Telepravir and the "compassionate" use. That means use now (without placebo) for Cirrhotic victims. While he couldn't give me a definite time line for the compassionate release, he did say that telepravir being in Phase III, they are seeking approval by the FDA in the second half of 2010, and making it available through prescription instead of the current clinical trials.

Interestingly, he added a comment that we could hopefully expedite the "compassionate" use approval by the FDA if we write them an email stating the urgency for those who need this NOW.

Here is a direct link, with phone number to the FDA: http://www.fda.gov/comments.html

Write to them and continue to bombard them with emails until they give in. This is a battle to be sure, but if the government sees that we are desperately seeking a compassionate release of Telepravir, they could rethink this whole matter. Write an email now...

Magnum

[Tippyclubb]

Consider it done, and we should do it daily.

[Magnum]

Here is a direct link to the email page...

http://www.fda.gov/cder/comment.htm

Magnum

[burned74]

thats a great idea.
my first email is going out today

[FlGuy]

Real letters could be more impactful, copying a federal legislator.  Ask for a letter back in reply.  Then follow-up with phone calls to the person who writes back.  Then, repeat...and repeat

[Magnum]

Here is the email I just sent:

Regarding the Vertex drug Telepravir (VX-950) for the treatment of Hepatitis C patients, I want to add that many of us are in Cirrhosis and need this new drug NOW!

You MUST release it for “compassionate” use to us who are dying, and not force us to attend clinical trials and possibly get placebos. This is our last hope. The alternative? To burden the Medicare system with the high cost of liver transplants.

The Telepravir drug is now in phase 3 (the final phase) and has shown remarkable abilities to clear this virus and allow the liver to regenerate.

We are willing to risk it even though phase 3 has not completed. As for all the literature and clinical trials results, the risk seems non-existent for toxicity . We are the people, and as Lincoln stated in the Gettysburg address, "and the government of the people, by the people, for the people, shall not perish from the earth".

Please listen to us people and rethink this as soon as possible. Many lives could be saved NOW...

[Tippyclubb]

Well, my letter was no where near eloquently stated as yours, but I sent one.  I also requested a reply.

I think FI guy has a good point about real letters and will write one of those also.

[Andiamo1]

Great idea - wonderful thread.  Here is the email I sent:

I am requesting that you approve Telaprevir for use as soon as possible.  There are many people that have been fighting HCV for many years and are now running out of options.  I know - I was one of them.
I am 68 years old and had HCV since I was 21 years old.  I repeatedly treated with the standard treatments to no avail.  The treatments were devastating in themselves and did not rid me of the disease.  I was rapidly progressing towards cirrhosis with very little hope.
I managed to get into the Telaprevir trial and was lucky enough to get the drug and not a placebo.  It worked, and I am now free of the virus at 48 weeks post treatment.

I sincerely want all people with this disease to have the chance to rid themselves of this devastating disease and not leave it to the lucky few that get in trials and avoid the placebo.

[Willy50]

You are a marvel; way to take the bull by the horns.

I think it is a great idea.  I actually would hope that they would allow approval for past treatment failures that will be put before them this year which could allow many more people to treat that have marginal hope for re-treating NOW.

I fully support allowing the compassionate use of TVR and especially in your case where there exists a very strong possibility that waiting for approval could be waiting too long.  

I will also write them but think I may try to do some "googling" and attempt to portray the scope of the problem.  Many people are up against the wall.  They have no little hope in treating again with the same treatment, and as they wait their chances of success goes down with advancing liver staging.  Treating cirrhotics is always more difficult and as they approach decompensation the toxicities of the treatments can also push people towards liver failure.

Treating these people through allowing "compassionate care" may also free up a liver that could go to another worthy person.  They could save two lives through allowing Vertex to treat this population.

Good enough for now.  Thanks for starting this thread.

Willy

[HectorSF]

Magnum, Thanks for being proactive on this! You've help us all.

Many times I've heard people on this forum ask what can they do to
make a difference in how we are served and treated by the medical community. I think this is a great opportunity for us to advocate for ourselves by letting our voices be heard.

I hope as many people on the forum as possible and pitch in on this worthy effort.

I will be making my voice heard on this issue.

I will also be writing to my Congresswoman, Nancy Pelosi to see if we can get more support for our HCV community as part of the ongoing overall health reform efforts of the Obama administration. This is a time of big changes in our government and a good time to make others in power aware of the impact this disease is having on us as patients and our medical system.

If we don't get more effective treatments available for us now, in time many more of us will be waiting for transplants, which are personally "life changing", and far more costly then treatments. There aren't enough livers to go around for everyone who needs one now. This will only get worst as us "boomers" age and our illness progresses. This is a tragedy in the making.

Thanks all for your good work everyone!
Hectorsf

[hopeful51]

Per your instructions"continue to bombard" I will start a B-52 mission a.s.a.p


And now I have a ? if you needed rescue drugs on standard tx. Would it be safe to assume that you would also need them if you were to tx with Telaprevir and I am to understand that you can not use rescue drugs with Telaprevia.

Can anyone help> How wrong do I have this?

Hopeful51

[BelB64]

Your letter was fantastic.  I would hope it would move the right people. By the way when speaking to your Teleprevir contact could you ask him how the European trials with Genotypes 2 and 3 are going and do the interim results compare favorably with the genotype 1 trials.

Thanks

[Rockerforlife]

You are a smart cookie i see,ill be sending an email and a hard copy letter also...ive often wondered why the 'compassinate care" never was talked about in the main stream...about time my brother...the ball is rolling...its also a shame what happened to us canadians in the tainted blood scandel in the 80`s,we never did get the proper compensation... if .they can afford to waste BILLIONS on wars...im sure they can help the sick..its time to save people...not kill them....

Rocker  4  LIFE

[HCA]

I think that you'll find that Vertex and it's partners and investors,together with the FDA and the medical profession are already acutely aware that there is a desperate human and economic need for effective treatment for the Hepatitis C virus.
It is for this reason that countless billions of dollars have been spent on the R&D of telaprevir and other agents.
All y'all is really saying today is 'We want it NOW!'
Well of course you do-you have advanced liver disease.So do I!
All life saving drugs have an eager and impatient patient poulation wanting to burn away the red tape.
I think this has less to do with the Gettysburg Address than with writing a cordial personal letter to the new CEO of Vertex asking him specific questions about what plans he may have for a compassionate programme,what contingencies are involved and what timescale may be anticipated.

[viaduk]

Thanks for starting this.  My email is below:

I am requesting that you approve Telaprevir for  “compassionate” use to those patients who have not responded to the current standard of care for Hepatitis C.  For those patients, particularly ones with cirrhosis, it is crucial that we be provided with this new and highly effective treatment.  At this point in our disease, it is more risky to be forced to resort to a clinical trial and the possibility of getting a placebos. Also, the trials' restriction on the use of “helper” medication for low WBC and RBC disqualifies many patients who may otherwise be able to clear this virus.

As a cirrhotic person who twice relapsed from previous treatments, I am anxiously waiting for the opportunity to treat with Telaprevir. I urge you to release this medication for “compassionate” use to those of us who may be facing a transplant or death.

[desrt]

Is anyone actually familiar with the waiver the patient has to sign for "compassionate" use and what the financial implications for your post-tx health care costs would be? As someone who takes half a dozen Rx I never had to take prior to FDA approved SOC, I would be more than a little curious.

[Willy50]

Your reply is a good wake up call.  I'm sure that the FDA is not about to release the drug prematurely.  I'm sure that none of us can talk them into doing so.  But consider.....

The drug approval may be at a tipping point.  The FDA may have ample proof to approve the drug FOR ALL past TX failures.  If the don't they very well may have it in weeks.  We don't have the data....the final data but from the SVR12's provided by Vertex months (and months) ago there was a comfortable superiority of the SVR rates respectively between triple therapy and SOC.  That is all that is required for the FDA to approve this drug since there is nothing superior available (barring safety issues, that is).

This is a drug that deserves an early approval.  We are talking about many lives on the line here.  In such a circumstance.....should we NOT even ASK?  LOL: should we just wait and hope that they do the right thing?  They always do the right thing after all; right?  
I don't always think so.  I think that some drugs have been held up (re-visit the morning after pill in the abstinence era), some have been approved too easily (my father died after being treated with Vioxx, but before the recall broke).  This is not a organization that always does things right.  Approving the wholesale use of the drug for past treatment failures or at the minimum for compassionate use could save many lives.  It is pretty much a no-brainer that many lives would be saved.  This is something that they could do right.  If you recall there was a great need for action during the AIDS epidemic.  The FDA has to look at the scope and magnitude of this drug and our situation and factor that into their timetable.

Speaking of HIV and AIDS.  That group of infected people really shook things up.  They got some media attention, they wrote letters, petitions, their congressmen and they took to the streets.  
...........And the government acted.

Then there is us with HCV; the SILENT KILLER.  
It's true.  The disease takes many people because they wait until it's too late to act.  I think that it speaks of us....the HCV infected.  All too often we remain silent.  We don't speak up.  We don't write our congressmen.  We choose to remain invisible and silent.  It's one reason that HCV gets about....what is it....5% of the funding that HIV has gotten for years although we outnumber them 2:1  More of us will die from HCV each year than from HIV.  What will it take for us to break our silence?

Should we ask for something?  GOD forbid; they might say no....... so .....lets not.  Let's don't.
Lets stay silent.  

I think it's called the silent killer for more than one reason.  

I say; lets do.
     Lets ask.  Lets explain what we want and why we want it.  Lets say who we are......  what we do for a living, where we live, that we have family.  That they can save our lives.  That in doing so..... for each person that they save by allowing compassionate care that they can save a life and reduce one person from the rolls who would need a liver transplant.  By reducing the rolls one person awaiting a transplant a second person can *also* be saved.  That person may be a veteran who acquired the virus serving our country.  It could be a mother who needed blood while giving birth to a child 30 years ago, or a first responder.  It could be a child now grown infected through vertical transmission.  It could be a hemophiliac who received tainted blood.  The FDA can give the gift of life by recognizing the need and by acting.  We have been waiting and we have been dying.

But first..... we may need to act.  
All that we need to do is ask.

Well...... that's my stimulus package.
  
If they are going to save some taxpayers lives they are going to need to act and quickly.  They are going to need to take some actions that convey that they will finally grant this population some of the care that was given to HIV infected citizens.  They can act and save lives..... or they can wait.

I only know that I will not wait to ask.  ; )

best,
Willy

[fretboard]

I just wrote mine, the quicker telaprevir comes out, the sooner other things will come out.  You never know what's gonna happen when you write an email to a federal agency, but it's certainly not gonna hurt anyone and it just may help.  Besides that I signed up for a couple of their email newsletters while I was there.  latr

[pjhep80]

excellent work mag i will email today also

[smaug48]

sent the first...

smaug

[Isobella]

Heartfelt thanks to you for this thread.  I am SO on-board.  

Working today, so I'll have plenty of time to send e-mail(s).


Nicely said, Willy =)

[portann]

Fantastic what you made happen here. Something's coming of this, I can feel it.

Maybe they'll send you home with loads of extra gift boxes of P.I.'s to acknowledge your major role in successfully lobbying for these meds ahead of schedule!

A really constructive move - thank you for being so much on the ball.

[nygirl7]

fyi when sending them an email always open a new browser up and don't just click it off this page otherwise if they do look (because of a surge in letters) they will see that all the letters are coming from this website - that makes it look  more like we are spamming them then if individuals are just writing.

It does make a difference.  Don't ask me how I know these stupid things........but it's true.

And keep it to as few words as possible, that helps too.

>>>Use bullet points if you can they stick out more than long paragraphs.

(Yeah I've been involved in some serious heavy duty email campaigns before). I'll post what else I remember if anything is important but that should help.

[portann]

.

[Willy50]

OK.... you made your point.      (.)     ; )

That has to be the briefest post ever; even more abbreviated than replying with a "smiley".

Willy