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215816 tn?1212490407

What's the FDA/Insurance saying to us?????????

Good Morning All,

      I had posted earlier a post on the 72 week course of treatment.  What I don't understand is I have read numerous post after post of people who have treated 5, 6, or even 7 times with the current medication, and unfortunately, each time they treated, it didn't work; hence, their multiple treatments of  round 2, round 3, and so on and so on.

      As we have seen in the successful 72 week treatment of one of our own, NYG7, that the extended therapy DOES/DID work, then why wouldn't it be considered cost effective, I wondered, for the insurance companies not to pay for 72 weeks?  Or even some our Dr's not to considered such an extension?   And if memory serves me correctly, our friend, NYG7, courageously battled mutiple strains of this horrible virus...HCV/HBV ( I think it was her.  I could be wrong, but I thought it was her... ..it could have been someone else...not sure...NGY7, forgive me if I got this wrong!)

     Instead, a person treats this disease of whatever type they have for whatever duration/weeks perscribed only to find out two or three months later that it's back...it didn't work.  So here's my question.  When did you begin your second treatment, your third treatment, and so on.  Was it a year later?  Months later?  Was it the insurance company that dictated when you could start again?
      ( Personally, those people working at our insurance companies and those charge of making decisions, you can can pretty much take it to the bank that if HCV were happening to them personally, there would not be any delays or denials in getting them their treatment. I lay good money that  anything they wanted or needed would be approved in a flash!!!   Does that make sense?)  Again, if it, VX-950,  has proven itself so far so good, or even that extending the standard tx of 48 to 72 weeks increases  a person's  chances/odds why wouldn't the insurance companies ( or even doctors ) not approve it????????  HMMMM?????

   Is it just me or has anyone else noticed that you can get a perscription right there in the Dr's office for any "recreational"  FDA approved drug to help you get it up and get it on if you have erectile dysfunction.  But Lord if you have HCV, " Well we need to do a little more studying before we approve it."  Or you can get a perscription for " FDA approved steroids"  from that same Dr if you have " low testosterone levels"... inject them into your body and then tell your family to run for their lives...as the sad and horrible recent news reported.  But once again, Lord help you if you have HCV.  Why don't they just come out and tell us, " Sorry, we need you to suffer a little bit longer before we approve  it."    The FDA's says their not going to approve so fast the promising drugs in the works/pipeline like VX-950. Their going to take forever and a day to get it to the market.  What are they worried about?  A recall?  The FDA history has a history of recalls.    Would a recall be something new for them?  Maybe there wouldn't be a recall on this promising new drug from Vertex. What's really the holdup here????    Again folks, just my take and my take only.  I'm just so frustrated with it all...insurance...aprroval....FDA.....( I don't know maybe you guys can help me get the BIGGER picture here.)
   Has anyone else noticed that not one HIV drug "released" to the market has been recalled, but then again, I could be wrong about that, but being coinfected with that as well, and treating both at the same time, I can't think of ONE!!!  They're approving them left and right it seems.  Yes we need them...don't get me wrong.  But we also need to be giving the chance QUICKLY to see about this new drug from Vertex.   They, right now,  have got SIX BRAND NEW HIV DRUGS that will be out on the market by year's end...THAT'S SIX.....YEAR'S END...less than five months away folks....FDA approved...trail tested...pipeline tested....blindstudied...whatever you feel comfortable in calling it or saying.  These HIV drugs go the same route before approved and market just like Vertex is trying with theirs.  Yes,  we do need the HIV drugs..please don't misunderstand me, ( everyone and I mean everyone infected worldwide with HIV)  and for that I am grateful.  But it just seems the FDA is dragging their butts and telling those suffering with HCV to suffer a little bit longer!!!  

     I guess I'm just so frustrated right now!  Over insurance...over how things are done...Maybe there is something to Micheal Moore's new film????????  Anyway thanks for letting me vent.....Hope all is well with you guys!!!  Take care...

Yours in Christ,
18 Responses
154668 tn?1290115995
I re-started 6 months after finishing 48 weeks.  I go to a known doctor that is at an university hospital that does clinical studies.  I recently found out that my doc had sent letters to the insurance company.  I don't know if  it was because I have cirrhosis or not, but he listed studies that shows there is a better svr chance with extended treatment.  He also did a cost, benefit analysis of what it will cost should my liver fail without treatment.

It is a double edge sword, we want the new drugs now.  If these drugs were pushed through without satisfactory studies, the liability would be staggering, and we would want to sue the drug companies and the FDA.  For the old timers, remember BILN 2061 was a promising protease inhibitors that was halted before it made to market due to cardiac toxicity.  I do believe that these currently studied drugs should be available to those that are running out of time.
179856 tn?1333547362
It's so stupid it kills me.  It really does.  You know they told me that if it was necessary they would pay for a transplant - but not for six months more of the meds!  Now, talk about poor rationale!

Thank God the drug companies are willing to step in.  I guess they figure that the only way to get the extension approved someday is to prove that it works.  I don't know why they made it so easy to get them but they sure did.

It's my belief, honestly, that insurance companies don't really WANT us to be cured.  Otherwise if we were all healthy they would be out of business. They are the biggest business there is - controlling even the government.  Why would they WANT us to be better?  Face it, they don't.  It's $$$$$ pure and simple.

They just do NOT care.

by the way I'm praying I am SVR - I was UND 4 1/2 months into treatment and I get my 6 mo PCR in the next two weeks (when I get the courage!).  Either way, it was DEFINITELY the right way to go (as proven by the studies) and I don't regret a minute of treating. It was tough, it was horrible, it was miserable but if I got rid of this disease...worth every single second.

All of my best to you Cirq!

NYGirl  aka Debby
179856 tn?1333547362
PS I didn't have HBV but I had two strains somehow of the HCV - geno1A and geno 1B.  Not that it matters but I just didn't want to leave a misconception up without saying the truth.

heck it was hard enough with ONE kind of Hep (c) I don't know what I'd do if I had two separate different kinds, argh!
217229 tn?1192762404
I agree with you on the insurance companies policies and issues and FDA approval times, etc.

Each disease is given a specific amount of money to treat - and each person has a set amount of money to spend per treatment or disease. I think that the INS companies should look at the broader range of things - however there really is no propaganda regarding HCV out there.

The advocate groups are hardly jumping up and screaming - and people themselves are being quiet about their diseases.

If people would stop being ashamed of this disease - then I think we'd find more funding - more cures and more ways of getting financial aid.

But because it's a silent disease that most people don't want to talk about because of the stigmata - then it will stay silent for raking in the bucks.

just my thoughts on it.

Avatar universal
Frustrating, isn't it? I think it can be summed up thusly, IGNORANCE AND STIGMA
Now, after many many years of work, education and activism, HIV is able to get the research dollars needed to put HIV drugs on the forefront. Sadly, there are many that can not access these remedies around the world.
HCV is like the ugly step sister disease that very few have been educated about, even those in the medical profession. It is also a "silent killer" so many with it don't show any symptoms as the disease does it's damage, We need  to do some acting up about HCV!

215816 tn?1212490407
Well said!  Yesterday I just got a little overwhelmed over a report on T.V. yesterday showing little ones who were infected with HIV across this world and didn't have the resources to access available meds!  And I'm thinking to myself, "Dear Lord, there are meds to at least improve their quality of life, and no way to get them for whatever the reason!"  Anyway, guys, I felt like I was sorta being irrational in vocalizing my feelings yesterday, but I truly wish that things were really different for everyone in a such a good way!  

I continue to pray for you all here that life will give you the best that it has to offer!!!  May He continue to bless you!!!

Yours in Christ,
220378 tn?1189755821
OH how I understand your frustration..I worked for 2 of the largest Insurance co. around..as I state I worked for them as I was terminated in december due to my medical condition...I guess I was too much of a finacial drain on them,needless to say I will never go back to t hat field of work again, EVER!!!!!!!!!
I do believe that what they like to do is say. hey we have tx for this disease, its not full proof, but it will increase your chances of remaining healthier until something better comes along..Why would they find a cure for any of these diseases?? They are making way to much $$$$ keeping us all sick!!!
I too am txing for 72 weeks..friday is my last injection, it really stinks but I want the best shot possible to remain svr..If I do relapse I won't tx again...This is a virus and there is no cure for a virus,just remission....the common cold is a virus and there are over 300 strains...
NY I pray for your 6 month pcr to be a good thing....I get a pcr done on monday..wish me luck! I am tired of txing...I am so glad to be done this week...I have been feeling blue today, just got over pnuemonia, antibiotics and go figure I wake up this am running a fever and feeling bad. Coughing massive headache,nose running,ears popping...swollen glands..ugh.!!! I feel like I am never going to be better again!!!
I wish us all the best, prayers and hugs to us all:) shelly
96938 tn?1189799858
Good luck as you mosey to #72.  If you have no intention to tx again, why have a pcr on Monday?
Avatar universal
We are so sick and tired of fighting this disease, many of us don't also have the energy to fight the insurance companies too. I want to go see Michael Moore's movie, "Sicko". A hospital gave me this HCV and by the time I found out about it it was too late to sue them - statutory limits had run out. I found out I had it in 1997 - 20 years after my transfusion.
220378 tn?1189755821
I am going to get it done to see if I am still undetected. I stand corrected that I will not tx with peg/copeg again. If something viable comes along and if it becomes detectable again I will weigh my options carefully at that point. I wish they could find a better tx for all of us...wishing you the best:) shelly
163305 tn?1333668571
  Yes, it is frustrating that greed has become the major motivating force for so many things. It drives me crazy that, as you said, there are people who desperately need the medicine yet we are told to throw away any extras we have! Throw it away, pollute the water systems with high potency drugs while children die???
   I think all we can do is strive to be kinder, compassionate people and share that with others.    
Avatar universal
The movie is well worth seeing, expect to both laugh and cry.
If you are a CA. resident, you can check out lots of info regarding this issue at Single Payer Now.

Our California nurses ( an incredibly hard working group of people) support it and they are in the trenches and know the scoop, which is our system is being held hostage by the private ins. co's and we all suffer for it while they reap incredible financial benefits while we are denied health benefits for having "preexisting" conditions.
96938 tn?1189799858
Hopefully, the thought will never need to occur.  As a 72'er you've earned your stripes, paid the dues, bellied up to the bar, met the challenge, looked it in the face, did what you needed to do and all those similar kinds of sayings.  So, good luck, get the last one over tomorrow and don't look back.
Avatar universal
I work for an insurance company (don't shoot!  It's not a medical insurance company) but I can safely say that my claim would not be given priority or special consideration.  Don't blame the people that work at those places.  They're just following the strict guidelines and trying to do their jobs.

HIV gets more money ergo more drugs for the people infected with it.  Maybe they could give us heppers electric blue phones and handbags to sell.  ;0)
148588 tn?1465778809
Bill1028 made a good point: those of us who have watched protease inhibitors come and go for the last 4-5 years remember that BILN2061 had even fewer overt side effects than VX. It made it into Phase 3 trials and was going to be the greatest thing since sliced bread. If they hadn't continued to do animal trials at the same time, they may not have found out about the cardio-toxicity until it was too late.
It's great that some people can do 72 weeks with an acceptable level of long term sx.  Until enough people do this and prove it has an acceptable benefit to risk ratio, it's going to be a 'do it at your own risk' thing.
Avatar universal
Yeah it all suck's! And on insurance issue don't even get me started. DENIED in my case :) There are no good treatments for Hepatitis. I have chronic active HBV VL 240 mill, and for us with B there is no solid treatment at all available. Just forever be on anti HIV drugs that are now being labeled for HBV as well.
217229 tn?1192762404
LMAO Johanna ---  what an interesting and very politically correct way of saying we're all in this stinking rat race together... and that it's all about the money... whether by purchase or lawsuits.

217229 tn?1192762404
It's a conspiracy theory --- only prob is that we're all in on it. It's a money making machine... from the way you eat --- to the way you drive --- to the tickets and laws that are made.

It all started way back when.... When Kings had underlings... Barons and Baronesses, Dukes and Duchesses... And they had their Barony or dukedom --- and the mayor of the Barony and Dukedoms all had to collect taxes to pay the King... Which of course the Peasants had to create the money...

And the Peasants worked the land - created the things that made money --- were taxed on their money... The Mayors took their cut... the Barons and Dukes took their cut... And the King and his underlings took their cut.

And new laws were made to generate more taxation...

And so on and so on...

Well --- now we live in the same system only it goes: Government - States - Cities and Municipalities...Individuals.

And the people who get their cuts are doing the same thing...

And now you have monopolizing companies (think Pharmacies, Oil Companies, Etc. Ad infinitum)  that own or control portions of the government by way of creating wealth and taxable contributions... (grin)...

And so ---- it goes on and on...

It IS a conspiracy --- just everyone is in on it --- and it's normal for everyone... Because that is how we learned life.

Now toss in the Mafia....


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