And Now For Something Completely Predictable: Law Suits with Hepatitis C Treatments

Hepatitis C Research:  This  trend to law suits was completely predictable, but right?  I think not.  In the words of a friend of mine “Fuck me, what do I know?”

Artwork:  Lapland Hand

I don’t know the answers, so I raise my hand to ask

Hepatitis C patients want to sue drug companies post  research treatment, claiming permanent emotional and mental damage. How do they know which came first? 

  Here is one site I found while looking into the topic, www.lloydwright.org    At the end you will note an absence of comment from me. I don’t know why I am lacking compassion. Am I a patient?  Am I a scientist?   

http://lloydwright.org/messages/content/i-was-better-hepatitis-c  I was better off with the Hepatitis C!

Name:

Mariel

Your Question for Lloyd

I was wondering how I get involved in the class action against interferon. While taking the drug, I dropped down to 79 lbs, and now have Gastroparesis and Crohns disease as a result.

The interferon paralyzed my stomach, and I am considering having a pacemaker put in because I am constantly vomitting and nausea us, and dropping dramatic weight. I am on disability because of this, and its caused me immense mental distress, as well as my daughters.

Please tell me what I need to do to get involved. I can not work and there for am unable to provide the life I wanted. I was better off with the hepatitis C! 🙂

I have just finished taking Interferon and Ribavirin for Hep C

I have just finished taking Interferon and Ribavirin for Hep C. I took it for 6 months and was cured of HEP C; however, no my liver and kidneys are suffering. Two months ago I had a perfect liver besides some fat. Now, I have Cirrhosis spots and the dr. said it has acquired 2 YEARS of damage in 30 days.
I was wondering if there was any lawsuit I could join or any other programs? I now am facing cancer most likely and have 4 children and nothing to leave behind to help them.
Thanks you. -Jim Thomas

Long Term Sides that ruined my life after hep c treatment

i WANT TO SUE FOR PAIN AND SUFFERING!!!!!

Can you help direct me?  “They never told me that I would be disabled permenantly when I treated in 2006,  My nervous system is a mess.  I have severe panic attacks, depression, eyesight is really bad, still ache all over, agoraphobia.   This has brought me down from being a productive & employed ‘to being below poverty level (cause I’m unstable i cannot hold a job for long) and I have been on the brinks of homelessness for the passed months;  I’ve been suffering since 2006.

This treatment ruined my life!

Sent: Thursday, November 10, 2011 3:55 PM To: LloydWright Subject: [Contact Lloyd] Severe disability resulting from Interferon + Ribavirin treatment in 2003. I was never warned and I’m seeking legal advice and/or recourse
_Smith sent a message using the contact form at  http://lloydwright.org/messages/contact.
post Interferon nightmare

In September 2008 I started Peg Interferon. I stopped after 6 months. Here is my story:
My name is Nick I am a now 30 year old father of an almost three year old little girl named _____. ( D.O.B.: ) and husband of a 32 year old wife named _____  (D.O.B.: ) I was 27 going on 28 years old when I found out I got the Hep. C Virus. About 6 months to a year before that I was giving plasma every 6 months until finally the next time I went in to give it I found out that recently I caught the Hep. C virus.

phase II clinical trial SOC and Boceprevir – Join the Suit

Lloyd Wright, An email friend referred your site. I am currently in a federal law suit for permanent injury sustained from my participation in a clinical trial of PegIntron / Rebetol / Boceprevir. I suffer multi-system sarcoidosis with occular, renal and pulmonary involvement caused by PegIntron and Rebetol treatment.

Lee Prokaska The Hamilton Spectator Canada (Jun 3, 2010)

It is virtually impossible to put an accurate and true dollar value on a loved one lost.

But when a mechanism is set up to try to do that, when responsibility is accepted by government, it is unacceptable for families to lose yet again by failing to receive the full compensation they deserve.

Group to sue over hepatitis C

People with hepatitis C have formed a group to sue the government and drugmakers for damages over their infection during mass vaccinations even though they have no clear evidence, such as medical charts.

  www.heplikeme.com

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Hepatitis C: Beware the Jabberwok

 Hepatitis C:  Beware the Jabberwok

Through the Looking Glass

‘Twas brillig, and the slithy toves
Did gyre and gimble in the wabe:
All mimsy were the borogoves,
And the mome raths outgrabe.

‘Beware the Jabberwock, my son!
The jaws that bite, the claws that catch!
Beware the Jubjub bird, and shun
The frumious Bandersnatch!’

He took his vorpal sword in hand:
Long time the manxome foe he sought 
So rested he by the Tumtum tree,
And stood a while in thought.

And, as in uffish thought he stood,
The Jabberwock, with eyes of flame,
Came whiffling through the tulgey wood,
And burbled as it came!

One two! One two! And through and through
The vorpal blade went snicker-snack!
He left it dead, and with its head
He went galumphing back.

‘And hast thou slain the Jabberwock?
Come to my arms, my beamish boy!
Oh frabjous day! Callooh! Callay!’
He chortled in his joy.

‘Twas brillig, and the slithy toves
Did gyre and gimble in the wabe:
All mimsy were the borogoves,
And the mome raths outgrabe.    

  

If you listen to a scientific lecture for an hour, you can begin to believe nonsense is science, but don’t.

I believe that the average Hep C patient (whoever that is) has a triple cross to bear.     1. You feel like shit on a stick  2. You have to go to unimaginable places like a liver biopsy suite and 3.You are thrown into a parallel universe where the language is almost understandable, but not really. It’s Jabberwok.

I was listening to a lecture yesterday on Hepatitis A through E. I was reading the slides as Dr. Nice Lady from pharmacy was talking.  And then I heard it:Hepatitis B and C are predominately associated with percutaneous and permucosal transmission”.  Translation:  Hep B and C can be caught through blood and through sexual contact.  Permucosal  is medical lingo for via mucous membranes.  The problem was that fifty pharmacists were about to  leave the lecture and tell their worlds that you can catch Hep C through sex.  I couldn’t let that happen so I said through the chat box “Hep C can be caught through sexual contact?  Is this new information?”  She said no, you are right to point that out, it is not transmitted that way.  So why did she say it?  The slide looked better that way.

In reality, the way one gets Hep C through sex is through rough sex and I mean rough.  Percutaneous means blood transmission.  I will pause here so that you create your own image.

Now I was willing to let it slide when she said that Hepatitis A and E were transmitted through the oral-fecal route.  In reality it is fecal-oral route.  Think about that for a moment.  But my point is that there is a lot of slightly non-true information out there.  What can you do about it?  Ask questions wherever you go.  Even if you have asked the same question before.  Remember how your doctor’s office always has that sign in English and Spanish that says Questions/Pregunta?  They really want you to ask.

Boy, did spellcheck light up Jabberwok!

http://en.wikipedia.org/wiki/Jabberwocky

Lewis Carroll Through the Looking Glass

Viral Hepatitis:  Keeping Your Patients Safe www.freece.com

The Hepatitis C Screen Door Swings Two Ways

My father-in-law wanted Viagra.  He wouldn’t shut up about it.  My mother-in-law finally said “Then what?  You’re not getting on me”  eewww, the visual for me….

So we screen for Hepatitis C, then what?

Attention Baby Boomers: The Centers For Disease Control (CDC), the group that tracks bird and swine flu, is thinking about screening you for Hepatitis C.

Hepatitis C is particularly dangerous because it is a silent killer. It can live for decades in a person’s body, slowly destroying the liver, while causing few symptoms,” said Dr. John Ward, director of the CDC’s division of viral hepatitis.

The new guidelines are expected to identify more than 800,000 infections, prevent 100,000 cases of cirrhosis, prevent more than 50,000 cases of liver cancer, and save more than 120,000 lives. Hepatitis C is the leading cause of liver transplants in the United States.

The relatively inexpensive blood test is “a small investment now for a big benefit later,” Ward said.

The CDC believes routine blood tests will address the largely preventable consequences of the disease, especially in light of newly available therapies that can cure around 75 percent of infections.

The field has attracted broad interest with two new hepatitis C drugs, Incivek from Vertex Pharmaceuticals Inc and Merck & Co’s Victrelis, reaching the U.S. market in the past year.

Sorry about the blur, link at bottom if you are interested

Should we screen for Hepatitis C in patients over 50?  There is no vaccine, the standard treatment of Interferon/Ribavirin is about  $60,000 and the eradication rate about 40-50% in the most common genotype (1).  Adding  Boceprevir (Victrelis) is $1,000 a week (x 24 weeks = $24,000). Telaprevir (Incivik) is $4,100 per week (x 24 weeks = $98,000).  So treatment =  $80,000 to $158,000.  They must be really proud of Telaprevir.  At that price they may have to keep it.  All of this assumes 24 week treatment but it is common practice for those on Interferon/Ribavirin to go 48 weeks ($120,000 for dual therapy)

 

These are all rounded numbers and this does not include anything but the drug.  Side effects are horrible.  A few are nausea/vomiting/diarrhea/depression/suicidal and homicidal thoughts/hair loss/anemia/insomnia . The new drugs add full body rash, rectal itching and/or rectal bleeding.  (This reminds me of the old treatments for syphilis: mercury and arsenic).   Many patients cannot hang and drop out. Jobs are lost, families strained and the patients overwhelmed. And then there is that pesky liver transplant for those beyond pharmacologic help (drugs).

But there are currently over 4 million people infected in the US and the largest group are over 50 with long-term damage.  And there are new tests and treatments.  For instance, researchers recently identified a specific DNA sequence in the gene that codes an immune response regulator, called IL28b. Different IL28b sequences predict whether treatment will successfully clear the virus.

With that in mind Goldhaber-Fiebert and Liu of Stanford created a computer model looking for the line at where it makes sense to go through treatment.  Remember that these people think in terms of how many patients out of 1,00 people, not what YOU should do.

After intense statistical and simulation analysis, the model showed that the new triple therapies were indeed cost-effective for chronic hepatitis C patients with advanced liver disease. Despite the large price tag and side effects, the new treatments help these patients avoid costly cancers and liver transplants — as well as allowing them to live longer, higher-quality lives.

For those patients with mild disease, the model indicated that determining their IL-28B genotype is the best next step, before prescribing a treatment.  The closer the threat of severe disease, the more justified treatment costs and risks become, said Goldhaber-Fiebert. “That would be the bottom line.”

Though these new drugs may offer relatively desirable options now, both Goldhaber-Fiebert and Liu noted that additional, and perhaps more effective, drugs are already in clinical trials.”

So in the “State-The-Obvious” department  they conclude: “As more and better treatments become available, the decision will continue to evolve, requiring further analysis, patients and health systems could also benefit from price competition with multiple treatment options available. But ultimately, treatment decisions will remain a private conversation between a doctor and a patient. “

A bit chicken shit but common in the academic world.  All studies end in “Further research is needed”.  Which is academic speak for “See you at the next medical conference where I will have more data”.  Note the reference to “health systems”.  This includes the insurance company.

Now, as a taxpayer, I wonder where the money is coming from. You can see one reason a clinical trial is an attractive option.  I didn’t pay a nickel.  In fact they paid my gas and parking.  BTW my results from 12 week post treatment just came back “No detectable virus”.  So why do I have a trace of cynicism about drug companies pushing for testing?

My mom used to yell, “close the screen door, you are letting the flies out”.  I always thought that was funny. Regarding screening and insurance that may be true but not so funny.

http://www.nlm.nih.gov/medlineplus/news/fullstory_125350.html

http://health.yahoo.net/news/s/nm/all-baby-boomers-should-get-tested-for-hepatitis-c-cdc

http://med.stanford.edu/ism/2012/february/hepatitis.html

Partial Responders with Hepatitis C

All Hepatitis C studies are not created equal. Duh

I used to see myself as smarter than the average bear.  Not so much now.

Being me, I was not passive when searching for a Hep C study.  But I was mistaken.   I assumed. Don’t make an assumption.  I knew better.   My mom taught me this.  Every time some of us kids got in trouble, she pulled me aside and said, “You know better”.  It was years before it dawned on me that other kids knew better too.  My mom was once a kid.  In fact she was still a kid when she had me.  In 1951 it was not cool to have a baby out-of-wedlock.  My biological father passed on marriage and she had to go back home to Harlan County, Ky.   This is where I was born.  Papaw told me to say I was from “Bloody Harlan” because of the bloody mine strikes.   So that is what I told my teacher.  Papaw and all Moms’ brothers were coal miners.  We didn’t make moonshine (the other career path)

I learned that the TV show Justified   is about Harlan County.  I don’t watch it myself.  Makes me jumpy.

fig 1.Me, Mom in the white car coat, dad that raised me, Mamaw, Papaw, and aunts. Harlan County, KY. My mom has the big nose like Papaw.  She waited to get a nose job after Papaw died

Coal tipple loads rail road cars 1

When I was a curly headed baby
My daddy sat me down upon his knee
He said, “Boy, you go to school and learn your letters
Don’t you be a dirty miner like me”

I used to think my daddy was a black man
With script enough to buy the company store
Now he goes downtown with empty pockets
And his face is white as a February snow

I was born and raised in the mouth of the Hazard Hollow
Coal cars rambled past my door
Now they’re standin’ in a rusty row all empty
And the L & N
Don’t stop here anymore

http://www.sing365.com/music/lyric.nsf/The-L-amp-N-Don’t-Stop-Here-Anymore-lyrics-Johnny-Cash/6B378501111ECA5D48256DEA000A5308

I love this song but never heard it until I moved to Texas

Where was I?    Okay brain get back on track.  Let me recommend that you do not have your driver’s license photo taken while on treatment. Very scary.

I chose to participate in a Multi Centered, Randomized, Placebo Controlled, Double Blinded study, evaluating Standard of Care (SOC) Interferon and Ribavirin (which had been my only choice all these years) vs. SOC and telaprevir for round one.  In fact I sought out this study. There were three arms, two with study drug.  I had a 66.7% chance of receiving study drug.  As I learned later, I was not randomized to study drug (telaprevir).  I assumed SOC included addressing anemia and other life threatening events.  In this case, SOC did not include blood transfusions or red blood cell (RBC) stimulant injections such as Procrit.  Standards of care have not caught up to current practices. Step one was to reduce the Ribavirin dose.  .  My hemoglobin (HgB) was 8.9 and the guideline minimum for taking Ribavirin is 10.0. Normal HgB range for females is 11.5-15.8 mg/dL.   My Ribavirin dose was decreased. Hemoglobin got slightly better but I paid for it later by not clearing the virus. In order to treat the anemia I would have to walk away from the study.  Dang it!   I quickly lost the ability to walk down a hallway, climb stairs or lift baggage without major shortness of breath (SOB) and the ability to complete a thought, all necessary for my job (oops, career). More about that later.

After treatment completion, an individual is assessed for response to measure viral load. If there is virus remaining but a reduction of disease by 30% or more  – it is called a partial response.   Partial response (PR) implies further treatment  required.  www.about.com   I moved from treatment naïve to partial responder.  Here I had saved myself for newer treatments but still got the same treatment that was available years ago.  Plus no treatment for the anemia.  How did a smart girl like me get in a dumb box like this?  I hung in there and finished the (long) 48 week trial.  Not only did I not have red blood cells (RBCs) or white blood cells (WBCs), but then the virus that was left was a stronger warrior.   Not good.  Here is the part where my education went out the window.  I was so depressed that I couldn’t function.  Every little thing was monumental.  I should have quit the study when my blood chemistry went to hell.  But I couldn’t think clearly enough to look at the situation logically.  All my decisions were made by a scared little girl.  See fig 1

You know I wanted to blame insurance companies.  It is so easy to blame insurance companies.  I wanted to blame pharmaceutical companies and the FDA.  They are easy targets too.  In reality, I, more than most, understand the study requirements and commitments. Sort of. I have been a research pharmacist for a couple of decades.  The data must be unsullied from outside forces like blood transfusions that will make it impossible to evaluate the toxicity.  That is the point of the study, not patient care.  Don’t misunderstand me.  Patients are well cared for. A patient can get treated without a study but a study cannot evaluate a treatment without patients

FYI, HgB is the molecule in the blood that carries oxygen, (O2) from your lungs to your blood and carbon dioxide (CO2) to your lungs so you can exhale this gas.  Speaking of HgB, it is a bucket brigade that carries water to a fire.  Even if you have plenty of water, if you don’t have enough buckets, the barn burns down.  Wait, that wasn’t a great example.  It wasn’t completely accurate either.  Never mind.  It’s just that I spent all these years learning this stuff; I want to get my money’s worth.  Kurt Vonnegut said only hermaphrodites use a semi colon; .Sort of.  While metaphorically I don’t relate to that, he did say it.   I didn’t pay Kurt Vonnegut, God rest your soul Mr. Rosewater.  Anyway my WORD grammar check said uses it.  I think I paid for that.  Yes of course I did.

Telaprevir (Incivek) and boceprevir (Victrelis) are now available to add to Standard of Care (SOC).  In fact by now they may be a part of SOC.  Glad I contributed to the body of knowledge that is clinical research.  Really I am.  But I wouldn’t repeat round one for nothing, not no way, not no how. It was two years before I was well enough to go for round two of treatment.  My career never recovered.

Why do you think they call it a LIVEr?

HepLikeMe: recovering from hepatitis treatment

If we didn’t need our livers to live, why are they named LIVEr?

If you have Hepatitis C and are reading this blog, I assume you have a working knowledge of this disease.  If not, there are great sites such as

http://www.cdc.gov/hepatitis/C/index.htm

and crap sites where lay people talk out their irresponsible asses.  If a statement starts with “I feel”, “I think” or “This herb won’t hurt, it is organic/ natural” run away.

My daughter tells me I have always been a bit ahead of the curve.  She says I am hep. I moved to the country and painted my mailbox blue before it was hep.   I got sober before it was hep. You get the idea. BTW hep is better than hip because Cab Calloway said it.

I like to type BTW.  You have been warned.

Indeed, Hepatitis C has now become main stream

http://www.chron.com/default/article/CDC-mulls-hepatitis-C-testing-for-boomers-3550384.php

I have just completed round two of treatment for Hepatitis C genotype 1.  Is the treatment worse than the disease?  No, but  that is difficult to grasp when you are asymptomatic.  Or at least you are ignoring symptoms.  This round sucked less of my life out of me, only because I brought the experience of round one.  Sounds like a prize fight. TKO I was technically knocked out by round one. I didn’t care after a while.  A new experience for me.

In order to survive, one must care.  The treatment says fuck it.  Don’t fuck it

In 2007 I began my first, and what I thought was my only, round of treatment for Hepatitis C.  The treatment, Pegylated Interferon and Ribavirin, did not clear the virus (we don’t say cure.  That is for hams).  What it did do was kick my ass to the curb.  The recovery was longer than the treatment and I never did get back to where I was.  All of my depression and insecurities bubbled up.  Depression is so depressing, insecurities so insecure.

In 2011 I began treatment with Interferon, Ribavirin, and two antiviral study drugs from Gilead Pharmaceuticals. Each drug attacks a different site in the virus life cycle. Early on there was no detectable virus.  Still not.  My treatment ended after a short (wink wink) 24 weeks.

Background:

In 1992 I donated blood and got a letter in the mail from the blood bank saying “you’re a winner.  You have Hepatitis C.  Please don’t give us your blood again.”  I was a winner.  No further information.  I went on with my life but didn’t donate blood and made it clear that my organs are not a gift to the living.  There was no proactive information regarding this disease and I had not exposed my liver to toxins in years.   I went underground with my secret.  Ironies abound. Forward a few years. I worked in Medical Affairs for a large pharmaceutical company, and my field of expertise was gastroenterology.  So, having access to the top research hepatologists, I had a liver biopsy performed for base line.  Marvelous results, you are great, minimal inflammation, no scarring or activity.  Go away and check back if things change.  Whatever that means.  I saved myself for new therapies.  I was treatment naive in the lingo. I love it when I can say words like naive.  There are web sites to define phase and staging of liver biopsies.  Bottom line,  Inconsistent

In 2007 during an annual physical, (which the AMA is now discouraging) my liver enzymes were elevated.  My internist wanted to send me to the local gastroenterologist, but me being Dr Science, I said no way.  And I pursued another research hepatologist.  Had another biopsy, phase one grade one activity.  Options, ignore or don’t. By then there was a minute amount of data indicating that maybe older patients (> 50) should go ahead and get treated.  That would be me.  Amazingly, there were no new available treatments.  So, I went to the government site www.clinicaltrials.gov , and entered my disease and city. Voila, there was a site with a randomized trial comparing Standard of Care (SOC) to SOC plus telaprevir.  This site was affiliated with a gastroenterology department at a medical school where I had a relationship (not relations) with the head of Gastroenterology/Hepatology. This DID NOT influence my ability to enter the trial.  But because of that relationship, I had confidence in and respect for the quality of research.

Enough for today.  This is a lot of work.

Deb