This Is What Is Needed To Stem The Tide - Mount Sinai Medical Center Launches Initiative to Erase the Stigma of Hepatitis C and Encourage Everyone to Get Tested

Being tested for the Hepatitis C virus is essential because it is so easy to miss and the incubation period of the disease is so long without actual physical effects or sickness. Although Mount Sinai Medical Center's Dr. Douglas Dieterich, Professor of Medicine in the Division of Liver Diseases and former Hepatitis C patient, believes the number of undiagnosed Hepatitis C patients is over 2 million, I feel that number should be expanded to close to 4 million. 

With the incredibly long incubation period and the multiple infections caused in the past by blood transfusions and in hospital procedures, the number will turn out to be much higher than expected. Since the virus can have an incubation period of 20 to 40 years, imagine how many innocent Americans could have been exposed before the blood supply was properly screened on a consistent basis. Remember that screening only began in America in May of 1990 when the FDA approved a test to screen the nation's blood supply. It took longer than expected for such a test to become a normative procedure in every hospital and clinic across the country. As a result, many people were accidentally infected in the 1990s. 

Since 2007, more people have died from HCV than from HIV. Such a statistic is astounding. What is even more frightening is that 4 times as many people will be die of complications from the Hepatitis C virus in 2020 than died in 2010. A fourfold increase is downright terrifying. Indeed, HCV is a modern American plague that needs to be addressed today. Yes, it is difficult to transmit and can only be transmitted through blood, but the number of people already infected have reached plague numbers. Once over 1% of a population is infected with a disease, it properly can be referred to as a plague.

NEW YORK, NY, Nov 16, 2011 (MARKETWIRE via COMTEX)

The Mount Sinai Medical Center has embarked on a new mission to educate the public about Hepatitis C and urge more Americans to be tested for this "silent killer." While two million people in the US suffer from Hepatitis C, an additional two million are undiagnosed, putting them at risk for devastating long-term effects. Through an important video program, The Mount Sinai Medical Center's Dr. Douglas Dieterich, Professor of Medicine in the Division of Liver Diseases and former Hepatitis C patient, urges people to take charge of their health by getting tested for the virus, even if no symptoms are present. 

Did you know that not all patients are IV drug or intranasal cocaine user? Other ways to contract the virus include: body piercings, tattoos, manicures, pedicures, or even while playing sports such as boxing and rugby.

How Did You Get Infected? So Many Innocents are so Terribly Surprised!

The virus can creep along very silently, presenting no symptoms or abnormal liver test results for 30-40 years--Hepatitis C is spread by blood to blood contact. If left undetected, the virus can lead to advanced scarring of the liver, or a condition known as cirrhosis, and eventually cause liver failure or other major complications including liver cancer--About 4 times as many people will die in 2020 from Hepatitis C then in 2010. "Many people around the world, probably the majority got it, through the fault of the health care system. They got infected needles from vaccines or other medical devices when they were in the medical world," says Dr. Dieterich.

Along with shattering the stigma surrounding the Hepatitis C virus, Dr. Dieterich wants patients to understand that testing positive for the virus is not a death sentence if caught early. Dr. Dieterich himself contracted the virus in 1977 while attending medical school. He accidentally stuck himself with a needle infected with Hepatitis C and suffered from a rare, but acute reaction. Frustrated with his diagnosis and lack of options to treat it, Dr. Dieterich dedicated his career to studying Hepatitis C and finding effective treatment options for those diagnosed. 

He was cured in 1998 after an 18-month regimen of daily interferon injections and Ribavirin -- an anti-viral drug that was unavailable at the time of his diagnosis. While he was lucky, he knew there was much more work to be done. Today patients have access to new, FDA-approved protease inhibitors that bring the cure rate to 80 percent. "If we can treat you, we can cure you almost all of the time. So go get tested before it's too late," says Dr. Dieterich

Wall Street Journal: Gilead's $11 Billion Gambit - Hefty Premium Paid for Tiny Pharmasset Reflects Potential of Hepatitis C Market

Are you wondering if it is true that the Hepatitis C market is the new number one focus of the pharmaceutical giants? Yes, the introduction of the Protease Inhibitors and the success of the treatment has blow the market wide open. It is truly a time of money to be made, according to Market Watch and other major financial sites. The infection rates are high all over the globe with little or no treatment available. HCV treatment is expensive, but it is becoming a worldwide necessity.

Shockingly High: The Global Percentages of Hepatitis C Infection Rates

This article from the Wall Street Journal about an eleven billion dollar gambit (yes that is $11 billion dollars) by Gilead is a perfect example of the truth of the above statement. 

Here is the beginning of the article by Ron Winslow and Peter Loftus.

Wall Street Journal (11-22-2011) Gilead Sciences Inc.'s agreement to pay nearly $11 billion to acquire tiny Pharmasset Inc. is a dramatic illustration of the market potential—and public-health challenges—involved in the battle against the hepatitis C virus.

Pharmasset, a Princeton, N.J., company with just over 80 employees and no commercial products, is developing a compound that Gilead and analysts say is on track to be part of the first all-oral regimen for treating hepatitis C. Experts say that gives it a distinct advantage over current treatments in the potentially huge U.S. and global markets for such drugs.

Night 136 Slipping Into Morning — Four New Poems (Between, His Best Customer, Licks Her Fur, In This Stillness)

I have been revising all of my old poetry, the almost 150 pages of loose first drafts that I found in my storage space from the past 20 odd years, and the writing is going well with a precise and finished feel. It is a pleasure to know that John Lavitt is singing the song he was put here on this earth to sing. 

The Puzzle of a Man - Let Me Show You What Can Be Found Within...

Here are four new poems...

between

between the first step taken

and lying down on a leather couch,

between the opening of a door

and the turning of the bedroom lock,

between putting pen to paper

and checking out what’s in the fridge

fall the sunken eyes of ennui.

between the biting of a nail

and the opening of a fist,

between the twitching of a palm

and the raising of a thumb,

between the flapping of tongues

and the calmness of silence

stands the bright shadow of courage.

his best customer

when the crack dealer

told me late one night

i was his best customer,

maybe, just maybe

it was time to stop.

he hides salvation

under his tongue;

sweet bitter ivory flakes.

perfect hunger answered,

in a transubstantiation

as the product is spit

into my quivering palm.

the best have dry mouths.

new boys all spittle and slobber,

the sacred reduced to sticky icky

and the eucharist wiped away.

i never learned his name

but he always took my money.

as i drove away drowning,

he hid the silver in his jowls.

licks her fur

with a royal languor,

the persian licks her fur,

clean as only a cat can be.

hairless apes waste so much water,

washing away the wondrous dirt,

ignorant to the story in the earth.

barely recall what the pet looked like,

all those years ago on that velvet couch

in an expensive paris apartment.

i search today for the feline soul,

but the cat's eye infected by invention;

there is nothing to find beyond myself.

in this stillness

my fingers grazed across the shallow of your back,

you spoke so softly, licking the inside of my ear.

each fleeting headstand worth ten thousand words.

you were there and i wasn’t. reality long gone.

i sang songs so sweet the emptiness disappeared,

i sang of a wooden puppet on the strings of desire.

you left me leaning on the crutches of bones,

my proclamations knocked over the ashtray.

did i make a mess when the rose failed to flower?

after the awkward hours of that night,

the first and last departure came and went.

did you pass the shallows, a sunken ship?

i always manage to stumble in a passionate fog,

my eyes forever blind to the obvious signs.

as the door closed, the boy still believed.

in the stillness of the darkest hour,

i still watch your car, behold one more vanishing,

the darkest car of the darkest night.

beyond the wailing of city lights,

you faded amid such glorified memories.

i would have forgiven you if you had returned.

the myth of the return everlasting,

fireworks under my skin, explosive beating;

frustrated, i cannot be still in this stillness.

my emptiness was never about you.

an impoverished tongue speaking in tongues.

every night, the fetish is born anew.

i do not even remember what you looked like.

who you really are lost in the drowning tides.

i craft this straw ballad to be, a dream solitary.

if you dream of love and you are alone,

do you betray the goddess of the heart?

i don’t know. i nod off in a vacant bed.

Night 136 - Long Silence As Ennui Sets In + The Side Effects Added To Warning Label Of Peg Interferon - Depression and Suicidal Ideation

I know I have been silent for almost ten days which is the longest gap since I started treatment. It is strange because you would think I would have been silent during he nightmare and living hell of the constant itch and pain of the rash and staph infection. But the blog was my life preserver during that six weeks of hell, and it provided me with a sense of value and faith. Now things have shifted as I slowly recover from the trauma while remaining on the Interferon and the Ribavirin. 

Although I See The Way Out, I Remain In The Dark Tunnel At Essence

Although I see the light at the end of the tunnel I am still in the tunnel, still nursing my wounds, and, in the stillness of the cold night, facing the weight of the consequences. I have shifted into the doldrums of ennui as my burned-out body sags to the floor, and I fall on the couch and surrender to the banality of just being uncomfortable. Mind you, being consistently uncomfortable 24-7 is so much better than being in the thick of hell on earth. I am grateful, but being out of the flames and the fire, you begin to register the price and the traumatic effects of the wounds and damage. It is a bit overwhelming as I give in to being a couchaholic once again and find refuge in the arms of my old brown leather couch.

At the same time, I am writing beautiful poetry, and I shall publish a few newly rewritten and completely revised poems in the next blog. Right now, I am healing from the most extreme trauma of my life, and I must be gentle with myself. It is hard and brutal at times, and I must realize the toll taken in terms of the extremity of my survival. Yes, I survived and even did well in the face of a such a living nightmare, but there was damage and there was a lasting price. Although the long-term consequences have turned out to be both negative and positive, I must recognize that the negative cannot be ignored and must be treated with the respect of the price and the necessity of healing and recovering slowly.

Finally, I am still on the Ribavirin and Peg Interferon for another 2.5 months. The traditional side effects of these two drugs is what you always heard about when people mentioned how awful and difficult the process of going through Hepatitis C treatment. The worst side effects I experienced was due to the new Protease Inhibitor, but I am in a clinical trial, the drug is completely new, and my side effects won the gold medal for the worst in the entire country, if not, the entire world of clinical trials. Nevertheless, the side effects of the other two drugs continues to be a challenge.

The Ribavirin and Peg Inteferon Side Effects Continue To Be A Challenge

Here is a recent article about side effects officially added to the Interferon warning label:

FDA Hepatitis Update - Important Updates to PegIntron Warning Labeling

On December 22, 2011, the Food and Drug Administration approved revisions to the product labeling for PegIntron to include the use of PegIntron with hepatitis C virus (HCV) NS3/4A protease inhibitors for the treatment of genotype 1, chronic hepatitis C (CHC) infection. Additionally, the product labeling was update to include revisions to the text regarding the use of PegIntron in patients with neuropsychiatric disorders. Changes were made to the Medication Guide for consistency. The following changes were made to the warning and precaution sections of the product labeling.

Warning and Precaution section was revised as follows:

Neuropsychiatric Events

Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PegIntron treatment and follow-up. Psychoses, hallucinations, bipolar disorders, and mania have been observed in patients treated with interferon alpha.

PegIntron should be used with caution in patients with a history of psychiatric disorders. Treatment with interferons may be associated with exacerbated symptoms of psychiatric disorders in patients with co-occurring psychiatric and substance use disorders. If treatment with interferons is initiated in patients with prior history or existence of psychiatric condition or with a history of substance use disorders, treatment considerations should include the need for drug screening and periodic health evaluation, including psychiatric symptom monitoring. Early intervention for re-emergence or development of neuropsychiatric symptoms and substance use is recommended.

Patients should be advised to report immediately any symptoms of depression or suicidal ideation to their prescribing physicians. Physicians should monitor all patients for evidence of depression and other psychiatric symptoms. If patients develop psychiatric problems, including clinical depression, it is recommended that the patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PegIntron be discontinued, and the patient followed, with psychiatric intervention as appropriate. In severe cases, PegIntron should be stopped immediately and psychiatric intervention instituted. Cases of encephalopathy have been observed in some patients, usually elderly, treated at higher doses of PegIntron.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration