can we get Telapriver approved sooner???

Dear Friends,
I was talking to the nurse at my liver clinic, a well renown place in S.F. When I said something about Telapriver she confided that she wishes some of her current patients would just wait until its approved.
SO, that got me moving.

I thought since we are not organized in the way the cancer or HIV lobbyists are but need approval of Telapriver  which can potentially save many livers and many lives, the least I can do is encourage everyone I know to write to the FDA, their representatives and anyone else we can think of.
I'm sending a request to everyone in my email address book.

I'm including my letter below which anyone can gladly cut and paste to send or use to compose one of their own. And if you have any other ideas, let me know.

I don't know if I'm on the right track, but what've we got to lose?

OH

mail your letters to:
***@****
here are links for contacting your representatives:
https://writerep.house.gov/writerep/welcome.shtml
http://www.senate.gov/general/contact_information/senators_cfm.cfm

To whom it may concern:

  I write concerning expediting FDA approval of the new medicine Telapriver.
The clinical trials have been completed and many HCV infected people are awaiting this new medicine.
Current treatment is long, expensive, difficult and doesn’t have a good success rate

Hepatitis C is the leading cause  for  liver transplantation in the U.S.
The need for livers exceeds the number of donor livers available.
We need approval of this medicine which can potentially save many livers and many lives.
Please, do all in your capacity to help push through the approval of Telapriver ASAP.
Peoples lives depend upon it.

Included below are some relevant figures,
Sincerely,
your name

About four million people in the United States have been infected with HCV. Since about 25% of those have cleared the virus, around 3 million people are carriers of HCV and can spread the virus to others.

WHO estimates that about 3% of the world’s population has been infected with HCV and that some 170 million are chronic carriers at risk of developing liver cirrhosis and/or liver cancer.
This makes it one of the most common infections world wide

www.cdc.gov
Hepatitis C virus (HCV) is a significant cause of morbidity and mortality in the United States and many parts of the world. HCV is also a cause of hepatocellular carcinoma (HCC). More importantly, HCC  is a cause of end-stage cirrhosis, occurring in 5% to 30% or those infected, and in the U.S., HCV-associated cirrhosis is the number one reason for liver transplant.

[SnoWav]

It is funny they will approve a experimental vaccine like H1N1 and give it to kids and pregnant women no problem

[desrt]

http://www.medhelp.org/posts/Hepatitis-C/Vertex-Replies/show/946507

This is where things stood as of last May. I don't know if anything has changed - this was specifically for 'compassionate use' exemption.

[orphanedhawk]

Apparently flu vaccines work differently. However I'm suspicious of the H1H1 too.

[JennyPenny]

Telaprevir trials are not complete. I do believe however that the drug is on fast track but it will not be approved any sooner than what we've been told....sometime in mid 2011. If you want to write anyway, I'd write to the FDA. The senate and white house will not be any help at all. We are hoping to get updated news at AASLD. Only 4 more weeks.

[orphanedhawk]

hey thanks,
I do sometimes put the cart before the horse
And I thought I read it the research was complete but my head has been a bit fuzzy.

I know HIV just had a med fast tracked. I wish it weren't all so political.

[copyman]

Not a chance it will be approved before 2011.

FDA's "fast track" is not that fast anymore. Mostly because of a few drugs they fast tracked causing deaths several years ago.

They now requier much more data before approval.

[JennyPenny]

I don't think you're putting the horse before the cart. I commend you for wanting to do something positive. So many people just complain but don't think to do a thing.

There are some differences that do give you a clue between what HIV got and why HCV didn't do as well. When HIV first became known people were dying fast. Children were infected and affected. There were famous people infected. And single diseases were still getting funding. They also had Ryan White funds. None of those things are happening in this day and age. That is one of the reasons we can't get upset when our funding is lumped with hep A & B, I do think you should send your letter. It sure can't hurt.

[orphanedhawk]

Hey guys,
I got this letter back from the FDA and I think we should write to them, put the pressure on, show them that there's a huge group of  us wanting this and don't want it pushed onto the back burner.
OH
Hello--
I found no public evidence that FDA has received a marketing application for this product.  
Given how recently the results of clinical trials with this product were released (see http://www.vrtx.com/current-projects/drug-candidates/telaprevir-VX-950.html), it appears likely that FDA has not yet received a marketing application.
Under Federal law, we are not allowed to discuss the regulatory status of any application which might be pending, including whether an application has been received.

However, I assure you that FDA appreciates the need for better treatments for HCV, and the agency conducts priority reviews of marketing applications for any products which represent a therapeutic advance.

I hope you find this information helpful.

David Banks

[newleaf09]

May as well include Schering Plough's Boceprevir with any requests.  It is on the same timeline as Vertex's Teleprevir and has same mode of activity and same results in trials.  Think we will see reports on both at AASLD and hopefully some further insights into their projected release dates.

You see a lot about Teleprevir because Vertex is a little company and issues a lot of press releases to create buzz.  Schering Plouugh is a multi-national comglomerate and rarely feels the need to create buzz for any of their products.  I think the 2 PI's are probably about the same.

[copyman]

you can go to vertex's website and listen to the last few webcasts where the CEO speaks about Telaprevir's timeline to market. he claims the earliest possible will be 2011. All the data will be in april 2010. can't remember everything he spoke about but I did remember about 2011 being when it would be available.

[orphanedhawk]

Okay, I did some more research and found out that the application process takes about a year once all the paper work is submitted.

According to the expert I tracked down, the biggest difference a letter writing campaign to the FDA would make is by a couple of months, maybe three at most.

If nothing else, I feel good about trying.
OH

[SnoWav]

with the big pharmaceutical company's almost running the medical system they are not rushing along a better TX when they have a expensive TX with only a 40% cure rate and repeat costumers. All about money