Dialogue with NVHR

After I posted the thread "News article denouncing US Gov underfunding for hep C", I sent a query to NVHR, the source of the article, and received a lengthy reply from its Director, Martha Saly, to which I in turn responded. Because I think this concerns everyone with hepatitis C, I am posting it here. (As it exceeds the 8,000 character limit, I have split it into two posts.)
=================================

Dear Ms. Saly-

How can the NVHR help, when its sponsors are the very pharmaceutical companies that are profiting from the HCV epidemic?

Yours,
Mike

======================================================

Dear Mike:

Why does NVHR take pharmaceutical company funding to do its work…. ? That is an excellent question and deserves a thoughtful answer. First, the reason we include the names of our pharmaceutical sponsors on our website is to maintain transparency. We do not intend to mislead the public or our constituents about the source of most of our funds. NVHR also benefits indirectly, but openly, from a small amount of funding from the Centers for Disease Control and Prevention (CDC).

The reality is, we would love not to need their money and support, but here are many reasons why we must turn to pharmaceutical companies to keep on doing our work.

In the ten years that I  have been active in this field (6 of them involved with NVHR), I have yet to find more than passing interest in viral hepatitis prevention and education among the legions of private foundations in America. That is not to say that there is no foundation or private money available to viral hepatitis interests, but it has been precious little. We have not been successful at gaining the attention of philanthropic organizations such as the Bill and Melinda Gates Foundation and others of their stature.

While 5 times more people in the U.S. suffer from hepatitis B or hepatitis C  than HIV/AIDS, we have found that there is no parity in public or private funding and much less attention to these diseases. NVHR does not advocate for reducing support for HIV/AIDS or any other disease, but we are working very hard to make hepatitis visible and to make people care about it. We’ve been told we are just not as “sexy” as second hand smoke or obesity.

A recent report by the Institute of Medicine noted that the general public, people who suffer with hepatitis B or C, and medical providers are staggeringly ignorant about the scope and consequences of viral hepatitis, including physicians who are frighteningly ignorant of diagnosis and treatment protocols! The IOM concludes that the current system is not working and there is much work to be done to address this burgeoning epidemic.

Our highest priority at NVHR is to get the federal government to pay attention to hepatitis. The CDC Division of Viral Hepatitis (DVH) is a part of the Center for HIV, STD, TB, and Viral Hepatitis. DVH receives only 2% of the overall funding of the Center. There is an average of $90,000 allocated to each state health department to address hepatitis B and C. That is pitiful! There is simply no money to support a public awareness campaign from the CDC that would elevate viral hepatitis to anywhere near HIV, breast cancer, heart disease or other disease specific campaigns. If the federal government increased funding to DVH through the appropriations process or by passing HR 3974, the Viral Hepatitis and Liver Cancer Prevention Act, there would not only be opportunities to fully fund state health departments to address viral hepatitis, the entire infrastructure – including community organizations – would likely benefit. Imagine the impact!

Of personal concern is that NVHR represents about a hundred community-based organizations. Many of these are small, do amazing work, and survive on a shoestring. Believe me, every time I apply for a grant, I think that the money that goes to NVHR might mean that a small organization will not get funded. What drives me to continue is the belief that if NVHR is successful, our member organizations will be successful.

Regarding the funding and support we get from pharmaceutical companies, I must tell you that NVHR does not adhere to anyone’s agenda but its own. NVHR’s steering committee, which is elected by our membership, sets annual priorities and sticks largely to our identified objectives. The drug companies do not have a say in the policies or structure of NVHR. They do not prescribe our actions. Having said that, I will also say that we have enjoyed not only the financial support of the companies acknowledged on our website, we have also benefited from the expertise and influence of these companies at various times. Frankly, they can afford to hire people with skills and credentials that we may not be able to access otherwise. It has been my personal experience, over many years of working with them, that there are individuals within these companies who have a genuine interest in viral hepatitis and have done everything in their power to help the grassroots community. Yes Virginia, there are human beings behind those big names and corporate logos – at least a few…. I can’t tell you how many people have left our movement to go to work for drug companies. While we chide them for going to “the dark side” we also feel just a bit better knowing that someone inside understands what we need.

Would I like to just say no to pharma funding? You bet I would! I would like to see a day when everyone in this country can identify the risks for hepatitis b and c in the same way they can tell you how AIDS is spread. I would like to see a day when the federal government pays attention and pays up! I would like to see a time that there is funding to address viral hepatitis from the grassroots to the treetops. Until that day I must find any way possible to make that happen.

I hope this letter answers your concerns. I am more than a bit curious as to why you (and ICIIU?) are interested in this issue.

Sincerely,

Martha Saly
Director
National Viral Hepatitis Roundtable (NVHR)

========================================================

Dear Martha Saly-

Thank you for your detailed reply to my query. I will address first your question about myself and the ICIIU, and then I have a few remarks regarding funding and sponsorship.

The ICIIU was an international Internet users organization created in 1998 to represent the interests of end-users in the struggle for influence in the private organization (finally, ICANN) that was granted control of the Internet databases, that is, the domain name system (the "root") by the U.S. Department of Commerce in 2002. Our struggle failed because of the duplicity of the U.S. Government, which although it had issued a white paper calling on all stakeholders to self-form a newco to oversee the root, actually had its own agenda which excluded end users and gave control to large private corporations, corporations with which those members of Government overseeing the Internet were and are financially involved.

Although the ICIIU failed in its mission, I did learn an important lesson: you cannot believe what the Government says. It does not have the interests of the American people at heart, but rather the financial interests of its own members. And those financial interests conflict, in the area of biomedical research just as much as in that of allocation and control of the internet domain name system, with the interests of the users, those of us who need and must pay for services. It is a sad state of affairs when government has become so corrupt that it represents only itself and the personal selfish ends of its members, and not the public it is delegated to represent. However, that is where we are now in our history, and it is no use ignoring or denying it. [continued below]

[mike716]

Dialogue with NVHR [continued]


What this seems to mean vis-a-vis health care, biomedical research, and clinical medicine, is that public funding goes to support and protect the profits of those corporations which have succeeded in corrupting government with well-paid sinecures on their boards of directors and with shares and share options; in brief, with economic power.

I was diagnosed, by pure chance in a routine blood test done for other reasons, with hepatitis C in 2008. I have so far received no treatment whatsoever, because I am deemed a slow progressor and am purported to have early-stage fibrosis (I say "purported to have" because there is as yet no reliable test for fibrosis stage!). I am supposed to submit to serial biopsies, in themselves dangerous procedures, which nevertheless do not give an accurate picture of disease progression; and perhaps at some future date, if the threat of cirrhosis, cancer, transplantation, and death becomes greater, be put on a regime of so-called antiviral drugs which have only a 25% chance of killing the virus (I am 65 and have genotype 1) yet are vastly expensive, and which will ruin my health in other respects, so that, even though I will probably still have the virus after treatment, I will have suffered irreversible physical deterioration, not as a result of the microbe, but of the treatment.

Yet at the same time other treatments have been found (therapeutic vaccines, fibrosis inhibitors, etc.) which have a real promise of eliminating the virus and/or the damage it causes to the liver, treatments that can be produced and sold for a fraction of the cost of the current so-called standard of care, and which have far fewer side effects. Why are these alternative treatments not developed and offered to people with this horrible disease? Because that would not be in the interest of the drug companies that are profiting so hugely from the sale of the drugs that, using their financial influence with government (read "power to corrupt"), they have succeeded in having granted the status of sole approved treatment available. Funding for other treatments is denied; the companies developing them are bought out or suppressed or their scientists co-opted; their trials go unsupported by medical institutions relying on grants from government and the pharmaceutical companies that profit from the policy of "no new HCV drugs", medical institutions directed by doctors corrupted by million-dollar sinecures in the form of consulting fees; and research on them is killed by laws, like safety criteria, applied discriminatorily. This corruption, a collusion between government, wealthy pharmaceutical companies, and research facilities for their own financial interest, is so far-reaching and its consequences so disastrous considering the number of persons infected globally, that it could with no exaggeration be considered a crime against humanity, on the level of the draining of the Amazon Basin and the Guarani Aquifer by agrobusiness.

The insurance companies would have put a stop to this unsustainable situation long ago if they were not themselves accomplices to it. But the medical system of the U.S. and of all the countries that have been coerced into copying it has been so designed that insurance companies profit from disease. And indeed our financial system, of which the medical system is a part, is a complex network of crimes, profitable to a few but disastrous to the many, which is why we are in the midst of a global and far-reaching financial crisis.

To return to the case in hand, naturally the more educated and experienced HCV infectees, grown desperate and furious by their intolerable situation, attempt to form themselves into pressure groups to revert it. To counteract such public offensives against their criminal behavior, public officials and the drug companies backing them preempt public action by creating their own domesticated and controlled public action groups. That is and always has been the policy of the U.S. Government, and it has been put into practice in this instance just it has in all other instances where popular revolt against unpopular government policies has threatened the status quo.

Your organization, the NVHR, is one of those organizations that has been created to pull the teeth of popular revolt against the crime of government and private complicity to deny hepatitis infectees an efficacious and affordable treatment. You, yourself, may not even be aware of this, or may be repressing your knowledge of it because of the benefits that accrue to you personally. But it is so nevertheless. The NVHR's usurpation of other more public-spirited organizations, and its provision of spokespersons who do not represent the community of infectees, is the proof.

You say: "Our highest priority at NVHR is to get the federal government to pay attention to hepatitis". This is nonsense. Of course the federal government is paying attention to hepatitis. It has put into practice those policies that will gain its members the highest financial rewards: hordes of panicked infected persons, and a sole costly and inefficacious treatment. You either err due to a hard-to-believe naivety, or are simply mendacious.

No pharmaceutical company funds an organization that does not promote its interests. NVHR's funding by the pharmaceutical companies that have cornered the market of HCV treatment requires that NVHR pursue those companies' interests. And that is what NVHR is doing, whether you know it and admit it or not.

Yours,
Mike

[HCVet]

Good job, Mike:) Well said. The truth is the truth period.... and you hit it on the head...

((((MIKE))))

[merryBe]

thanks, Mike, I actually found MArtha's response refreshing and will take it at face value.

I think there's an important concept here Mike....glass half full, or glass half empty.

sure, we could say the drug companies are in no big hurry to find natural cures they can't profit from, and that would have merit....tamoxifan (tamoxifen) was discovered, they patented a chemical form of the natural, and di make money...it htis case that was a good thing, since the natural was hard to cultivate and refine, and expensive as well...in the end, breast cancer patients are alive today thanks to those patents...
and they wouldn't have saved anything over the natural...

but let's keep in mind what docs and drug companies do...they try to understand and research mechanisms of disease, and cure them.
they then take those profits and put lots of them back into research to try to cure the next big disease...by these methods we've learned to cure and prevent more things in the last hundred years than in the last 4000 that preceded them.

here are a few words...just a few things I've been reading up on recently that are under investigation right now...there are hundreds, but these are just what I've been reading on this month:

Ion channel studies

electropolation vaccines

hydrophoic amino acid pair research.

tetraspanin CD81,  and it junction with junction Claudin-1,

cytokine blockers,

anti-CD81 antibodies,

mechanisms of the NS3-4A protease complex,

lipid metabolism,

anti-fibrotics,

protease and other inhibitors classes of course,

and a host of other mechanisms much too vast to even list in here are all being studied....thousands of studies costing billions of dollars are ongoing NOW as we speak for this disease.

and who does these studies?  Doctors, microbiologists and lab geeks.
and who funds these studies? Drug companies and governments.

so if I understand what you are saying, then all of this is for naught and a big conspiracy to keep folks from ever getting well?? Is that what you are saying?
Because, I do not want to misinterpret the intent of your message, so please tell me what you mean by

.>>>>>>>>>>Funding for other treatments is denied; the companies developing them are bought out or suppressed or their scientists co-opted; their trials go unsupported by medical institutions relying on grants from government and the pharmaceutical companies that profit from the policy of "no new HCV drugs", medical institutions directed by doctors corrupted by million-dollar sinecures in the form of consulting fees; and research on them is killed by laws, like safety criteria, applied discriminatorily. This corruption, a collusion between government, wealthy pharmaceutical companies, and research facilities for their own financial interest, is so far-reaching and its consequences so disastrous considering the number of persons infected globally, that it could with no exaggeration be considered a crime against humanity, <<<<<<<<<<<<<<<<<<<<

so Mike, you are saying in other words that all the efforts are murderous...that every thing that shows promise is supressed, that every doctor and reearcher is in the hip pocket of some greed drug lord...really?  every one of them??

if they want no new hcv drugs does it make sense that does are not in phase 3 trials?

I think you may be missing something I don't think the drug companies are missing.
that is that the hepatitis virus is now epidemic worldwide, that in short order there will not be one family on earth not infected with this virus, that worldwide 1 in 6 or 1 in 7 people now carry this virus, and in 20 years, absent cures, that could be 1 in 2.
Every other person could have hepatitis.

My guess therefore, is that the urge for self protection should grow exponentially and though I hate to see more folks get this, we can at least take comfort in the fact that if any disease was EVER positioned to come off the back burner and get fully funded and researched to the hilt, it's this one!!!
tell me why I'm wrong.

mb

[Diamando6]

I entirely agree with Mary and Mike. All I can say is that , they might find some solution ,if by any case one of their closest familly members become infected with on of those creaters. In other words, if Bear start knocking at their doors, maybe they'll get frightend, like we all are here!

[HCVet]

Martha Sally response to Mike- Quote "Why does NVHR take pharmaceutical company funding to do its work…. ? That is an excellent question and deserves a thoughtful answer. First, the reason we include the names of our pharmaceutical sponsors on our website is to maintain transparency..."

Mike, Transparency prevents subversion of law, corporate rip-offs, and corrosive self-dealing.  If you want government to work, you must be able to watch its inner workings.

Ask Ms. Sally, who, from their own organizational (NVHR) members, let alone the community, were consulted with the drafting of any legislation; including  when first introduced as the Hepatitis C Prevention and Control act back in 2001. The bill was proposed by NVHR but under it's prior name, the National Advocacy Council...

The answer is no one was consulted, including their own. The HIV groups drafted this piece of.... and puts all research and prevention $$ toward their agendas. Ask Ms Sally, how much funding they get from the AIDS orgs...

Out of 5+ million with HCV, less than 300,000 are co infected with HIV, and of that.... near 200,000 are gay. Yet the research branch of gov, NIH, has spent the bulk of appropriated research funding for HCV on HIV then reported to congress as HCV specific disease funding.

The greater part of NIH-HCV investments; do not advance research for prevention, vaccines, treatments, or cures for the majority afflicted.  The data is evident in the charts and documentation compiled from the NIH’s Research Online Reporting Tool (RePORT).  http://hcvets.com/NIH/FormalComplaint/Petition.asp

A compelling example- NIH awarded only one research project, totaling $156,104, for Cirrhosis in 2009.  Despite the fact, one in 2 men and 1 in 3 women will develop cirrhosis and suffer from many diseases and conditions that could diminish with research investments.

And, what about diabetes.... most, if not all of us, have some form of sugar imbalance. It's taken years to get researchers to look at the affects of sugar on SVR because the powers that be have other plans. So, to support legislation that does nothing for HCV patients or directs most resources to another agenda is insane.

I see the glass half empty with these folks, because the patients will barely benefit from any of the funding if the current legislation passes. Sad part, most will think gov is doing something for us and NVHR will continue to sell us out if the bill passes, and on a global level.


T

[JennyPenny2009]

Ok, I get it. I'll clean this up a little bit. The misinformation in this thread is appalling. NHVR does not spring out of NHCAC. NHCAC is a hepatitis C only organization that helps to capacity build for it's members. NVHR works in the broader sense in that it represents all viral hepatitis. As for NVHR not being made up of people who are infected or affected by hepatitis, that is ludicrous. Check your facts before you hit send. Ms Saly is SVR, Ms Sandt's brother is SVR, Mr. Simon's wife is stage 4, Mr Burkett and Mr. Ninburg are also SVR. Your statements are just not true.

Who but the pharma companies are going to create the treatments that save your lives? Of course we are upset as patients about the costs of these drugs. It is what it is. We cannot change that. It's expensive to develop the drugs. Have you ever visited a research lab?  Try it some time and then go out and help some of the advocates. You might like it.

So please spare the rest of us your divisevness and rhetoric. Check your facts. AND, think about saying thank you to those advocates who work their a**es off for you for no compensation.

[jdwithhcv]

Thank you.  I have only a small idea of how hard you work.  Thank you for your hard work and thank you for your post.  The information is appreciated.

jd

[mikesimon]

I want to thank you too.
Mike

[Bill1954]

Thanks, Suzie—

I read both this as well as the previous post; both were/are on task and appropriate, in my view. I too would like to thank you for your work and appreciate your input—

Bill

[Bill1954]

And you delivered the info without resorting to rant :o)...

[JennyPenny2009]

Thanks for your support guys. I'm not looking for thanks. But I love to hear it when someone like my hubby or some of the other advocates who get nothing but personal satisfaction for their time and work, are thanked. So I will pass your thanks on to them. They are the ones who really deserve it.

[CoWriter]

How about Chris Taylor from the National Alliance of State & Territorial AIDS Directors? He's in the Steering Committee at NVHR.   Does he have HCV?  Because we have asked him multiple times and he hasn't answered us.

The reason I ask is because he's representing all Hep C patients in the US as a Board Member for the World Hepatitis Alliance, which is in violation of their guidelines which state that to be a full voting member or be chosen for the Board he must be a Hepatitis patient (which is also what Mr Gore said) and the organization must have chronic viral hepatitis as their primary area of activity.

You don't know whether he has hepatitis?  That would mean that you held an election without knowing whether he met the requirements.  Because Mr Gore said you set up the election that got Chris Taylor chosen as Board Member.  

BTW, can you tell me which organizations voted?

Co
P.S.  Before anybody asks ME whether I have Hepatitis.....No, I don't.  But my mother died of end stage liver disease after being on a ventilator for two weeks and one of my brothers has Hepatitis C....and my father has liver/kidney cancer.

[JennyPenny2009]

If you mean that I listed the names in Survey Monkey for the voting, that is correct. That is all I did. Chris won the election to be the representative for the North America Region for the World Hepatitis Day Events. In order to vote, you had to be a member of one of the hepatitis orgs. If I remember correctly Chris Taylor was Chairman of NVHR at the time and also an employee of NASTAD which needs to change their name due to their involvement with viral hepatitis. I can't tell you which orgs voted as I had nothing to do with that and besides it was 3 years ago, I believe. As for Chris keeping his medical history private is his perogative. Some people like their privacy. Chris was also the Hepatitis C Coordinator in the State of Iowa before he went with NASTAD.

Personally, I don't care who has hep C and who has chicken pox. If they are giving their time to Hepatitis C, as a patient, I can't thank them enough. You did NOT need to be a patient to be the rep. You needed to work in the community. That I am sure about. Many non-patient advocates added their name to the list to be voted upon. Are you sure you are not getting the two boards confused?

I'm glad you are not a patient, Co. I'm sorry about your family members.

[CoWriter]

I can't thank you enough.  You just gave me all the answers I was looking for ; )

Co

[JennyPenny2009]

I try Co. When I say you didn't have to be a patient to be a rep, I remember it to be that you just had to be an advocate that is working in a registered (in the U.S. at least) advocacy group. You couldn't just be someone who runs a support group or posts on a message board,. They wanted the representatives from the various continents to be actively working for an advocacy organization as a volunteeer or an employee.

[willing]

perhaps my expectations are too low, but I've always thought it fortunate that drug companies are furiously competing to capture a share of the multi-billion HCV market. Not, that I have illusions about  their good intentions - they are machines for making wealth and morality plays no more a role in their operation than in my toaster's, but it's always seemed a stroke of luck that interests coincided.  

As best I can tell, essentially *all* hcv research is pharma funded (check the competing interests section of any hcv-related publication; funding acknowledgments for clinical studies; conference sponsors, etc.) If not them who else ? Does any one really believe scarce government funding would/should be pulled away from areas that receive no pharma attention and devoted to what, from a public-health perspective remains, on average,  a moderately benign chronic illness (anyone want to trade their HCV infection for HIV?)

The upcoming FDA comment period, is an excellent opportunity to address areas where pharma's goals (market domination) and patient goals (a cure) diverge. Pharma needs FDA approval to start making money, and this may be the last opportunity for a while to influence their actions. In particular, they've made it clear they will not cooperate on combo-tx from multiple vendors. The Federal Register announcement is here

http://edocket.access.gpo.gov/2010/pdf/2010-5055.pdf

Note the excerpt:
"Because treatment of CHC requires multiple agents to achieve acceptable SVR rates and to reduce the emergence of drug resistance to single agents or drug classes, treatment INDs that include two or more investigational agents or that allow for co-enrollment in several treatment IND programs are options to consider, particularly for previous null responders or for patients who cannot take interferon-based regimens"

[JennyPenny2009]

I agree with all you've said except the part about not being willing to trade HCV for HIV. Not that either diseases are a picnic but the Co-infected are dying in large part because of their HCV, not their HIV. HIV can be controlled now for very long periods of time with the antivirals. Sure HCV has a cure for some and HIV does not. But many more HIV patients are living a long time while the drugs keep them undetected. Whereas those who do not respond to SOC are often progressing to endstage liver disease. Not a pretty picture.

[HCVet]

JennyPenny2009 writes- The misinformation in this thread is appalling. NHVR does not spring out of NHCAC.

I think you need to check the former founders and presidents of NHCAC... Same group as NHVR, Mike Numburg, Loran Sandt, Steve Graham.... They teamed up with the Hep B foundation after the Hep C bill failed to pass year after year. Even members of congress considered the bill whacked as they do the current one. Same bill different title.  

We've had way too many fail TX and/or die to call this treatment a success and yet more research goes to co infection than HCV. The Pharms tell us just keep doing the TX, at what $25-30 thou a whack.  Now add the PIs... It's obvious the patient is not the priority here. I'm sorry you don't see that.

There are plenty of great advocates out here fed up with this charade.
And there are plenty of great advocates blind sided as well...  

I'm sure you are a good advocate by the looks of the risk factors listed on your site... good job, but you won't find these risks listed in the bill or on public health sites.

What we find most odd... how harm reduction programs put HIV and HCV in the same basket but not HBV. When we contacted them, were told not enough research to show HBV would benefit from the needle exchange awareness campaigns, despite the huge urban studies that say differently.

If NVHR wants legislation to pass then they need to address HCV issues not confuse us with HBV and belittle us with HIV by making HCV an STD.. to which it is not...

We'd get a lot more done working together but don't ask us to cave in so NVHR can position it self. Loran once told us when she was pres of NHCAC, you can't change the CDC, that this was the best they could do.

Well, we changed the CDC, got the director fired and the CDC Foundation rethinking it's approach to HCV. Now if NVHR would see the light we just might get somewhere.

We have no problem with NVHR running the show as long as it's transparent, and focused on HCV issues/patients including the 2.6 million retired military and veterans that the VA refuses to provide awareness campaigns for.


T

[Mr Liver]

HCVet- You should consider partnering with the HIV/AIDS community not pitting one diseased group over the other. The HIV community is better organized, has many more political relationships, more lobbyists, a good understanding of how to run fundraising and media campaigns, and all the contacts to do it. Since HCV has become a recognized health problem in the HIV community they have been very receptive about partnering with the HCV org I worked with for years. I still do occasional work with them and the alliances forged between the two communites is stronger than ever. I'd hate to see short-sightedness on anyone's part damaging these arrangements which have yielded increased opportunity to raise awareness and prevention campaigns, not to mention increased monies through mutual fundraising events . You cannot demand equal footing for funds for a disease on its way out in the US. It just comes across like a whiny case of sour grapes. Embrace your HIV friends and all will be better.

Jenny--If people only knew how hard it is to procure funding they might lower their bias against pharms somewhat. As we both know the truth of the matter is without drug co funding there would be no awareness and prevention campaigns. We would have to shut down most of the support groups in the state even !

I have to disagree on the topic of HIV/HCV co-infection. It is not the HCV that is raising the mortality rates in the HIV community, it is the co-infected. HCV mortality rates in the general population are extremely low. And as pointed out mortality rates in those with HIV are even better, with nearly the same mortality rate as the public.It's big trouble only when the two diseases are concomitant. There is a synergy that exists whereby the sum effect is greater than the parts.

all- Like it or not HCV is an epidemic that WAS. Its on its way out and will join the many other diseases that man has eradicated or reduced the threat to near zero through vaccines and prevention programs. Its not a disease that the US gov't fears enough to fund it heavily. And why should they fear it ? From a high of 280,000 new infections per year THROUGHOUT the eighties to 16,000 last year, paints a clear enough picture why no one in DC is fearful of HCV. The last vestiges of the virus in the US will be among IVDU and those who have been in prison populations. Starting in a few years (appx 2017) the list of known HCV infections will start to plummet in the US and Europe, the two largest current markets for the pharms. All pharms want to make effective treatments so they can grab the biggest share of the market before it starts shrinking. It was only 10 years ago you had to scour the net to find more than two or three unique clinical trials. Today, the number of trials  are so many you cannot even stay up on them. There is more HCV research going on today than EVER before in history regardless of any decreases in gov't funding. I think this is news worth celebrating instead of focusing on where the money comes from. - ML

[Trish77]

"all- Like it or not HCV is an epidemic that WAS. Its on its way out and will join the many other diseases that man has eradicated or reduced the threat to near zero through vaccines and prevention programs. Its not a disease that the US gov't fears enough to fund it heavily. And why should they fear it ?"

You only seem to focus on new INFECTIONS.  However, the issue isn't only the new infections, it's the new diagnoses of HCV.  The infections may have taken place some years ago.  The fact that it takes a direct test to diagnose Hepatitis C, a reason for a physician to even consider ordering that test and that symptoms for HCV either don't demonstrate until liver damage is advanced or aren't recognized by the medical community as yet as being potentially associated with HCV, makes those diagnoses quite delayed.  

Case in point - in my own province of Ontario, cumulative reported cases of infection in 1994 were under 10,000.  A mere 10 years later in 2004, that same total had risen to just over 70,000 by end of 2004.   You're obfuscating when you talk about new infections only rather than new diagnoses.

The estimates of those who are as yet undiagnosed are also rather large

I know in Canada the hepatology community is quite concerned that HCV is the epidemic that is COMING, as the number of DIAGNOSES increases, the costs to the healthcare system will GROW exponentially. The hepatology and medical community would like to catch HCV before it moves on to end stage liver disease and transplant candidates.

While my comments are Canada-centric, I certainly doubt that the U.S. is much different.

You need to look at the current state of existing HCV and what is required, not only on the decreasing infection rate.  That's only one part of the whole.  So much more to say on this but, thankfully, that's all I have time for in this post.

Trish

[JennyPenny2009]

Mr. Liver are you taken? I think I'm in love. j/k!! Thank you for the fabulous lesson on the Co-infected issue. The whole thing makes much more sense to me now. I appreciate the information and your perspectgive. I couldn't have come close to explaining myself regarding the main issues of this thread but you did an exemplary job. Thanks so much.

Trish, you are correct and no, it is not just Canada-centric. The feelings are the same here in the States. With the number of baby boomers who are expected to be diagnosed and the numbers who will suffer with endstage and HCC in the coming few decades, it is still a huge problem.

The fact is that the government is finally listening. It has taken years,  making and managing new partnerships between all the hep viruses and the HIV community, and a Senator with the disease, it is finally happening. As a patient with Stage 4 disease,I am not embarrased to say that I am thankful for anything the government throws our way.

And for HCVvet, the members do not consider either of the bills whacked. That's all I care to say on that issue. It doesn't pay for me to run my bp up on the same old issues that a few insist on twisting to fit their agendas. Sorry, I just no longer have the strength or health to go there.

[HCVet]

To Mr. Liver, All

FYI- The CDC established the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) an integration of existing programs with new programs, like Viral Hepatitis, was developed to correlate with the HIV/AIDS management model based on specific risks and disease pathology.   STD and Substance Abuse programs associated with the spread of HIV/AIDS received increased attention and funding, blurring the other components of HCV disease.  

NCHHSTP has meet with resistance from many advocates and congressional leaders, because of the increased effort by public health agencies to narrowly define HCV’s pathology and high-risk groups to more closely associate with HIV/AIDS risks.

Although these integration efforts offer a compelling savings for governments, and a seemingly powerful approach to prevention, control and regulation, especially reaching certain populations at a high risk for disease transmission and acquisition; it lacks the ability that component programs have in appraisal and regulation of health risks that do not fall within the perimeters of HIV disease spread. Discrimination is fostered for access to health services and medicines.

Through integration and emphasizing on the few co-infections over many mono-infection, these private and public health agencies have been able to prevent a funding shift away from HIV/AIDS and position themselves for future funding without changing the public health priority.  

This manipulation of the true understanding of a disease as well as its impact on society is a direct violation of the publics' trust and sets a dangerous precedent for all disease recognition.

Surveillance limitations, such as lack of funding, affects disease reporting. Combined with the lack of a well developed educational campaign to providers and only testing a targeted population, misses the mark in determining the scope of infection.  And the federal level HCV surveillance, overseen by NCHHSTP, ignores the larger chronically infected population in order to direct recourse to a strategy aimed at standardized elements for prevention interventions and evaluation activities. This established framework to integrate all of NCHHSTP’s prevention activities, defines who should be tested. Funding is prioritizes for programs that implement or follow these practices.  

Successful integration of prevention services requires specialized training to build capacity at federal, state, and local levels. However, the data suggests that the poor public health response may be the direct result of a system in disarray – seemingly captured by special interest with law and political agendas that have influenced the response to the epidemic.

This approach has created disparities in access to health care and created “social labels” that have fostered discrimination, responsible for the reduction in quality of life. A review of published articles addressing the stigma associated with HCV, found that those infected identified the source of their stigma with the connection of HCV with HIV/AIDS; promiscuity and substance abuse, while providers associated the patients with IV drug abuse and deserving of their infection..

Zickmund et al., Stigmatization and the Quality of Life J Gen Intern Med 2003; 18:835–844.

Paterson et al, The depiction of stigmatization in research about HCV International Journal of Drug Policy 18 (2007) 364–373

Public health privatization policies and pharmaceutical driven coalitions are agents driving legislation, underscoring the need to evaluate programs at this level. These industry coalitions and their “for profit” and “non-profit” counterparts, fight for government funding thru regulation by fomenting scientific uncertainty that work against broader public health threats.  

The enduring legacy and indifference for governments, nonprofits, advocates, political parties or economic elites, have grave and global consequences. It's impossible to embraced HIV resources when there is no intention on their part to stop the spread or protect HCV patent's need.

Let's be clear, the legislation before congress does not provide research dollars for treatments. That money is allocated by congress. The bill just provides HIV prevention, educations and referral services under the cloak of HCV. Oh yea, vaccinations, Hep B only, to which it is projected, that half of this award  will be distributed.

Before entering the public school system in the United States, children must be vaccinated for hepatitis A and B.  This has reduced the infection rates substantially. Acute infections have dropped from 1.2 million in 2004 to less than 200,000 reported annually by the CDC. For those without HCV/liver disease, who may not have been vaccinated and become infected, HAV is expected to resolve in 100% of the cases while hepatitis B has an 85-90% expected resolve rate.  10-15% will become chronic cases with disease progression and outcomes similar to HCV when liver failure is responsible for the HCV patient’s death.  So, a program promoting vaccination of HBV should be assessed for need and then consist of identifiable metrics to gauge the effectiveness of the program.  If vaccination is already required in the USA, then we need to better articulate the need.  We also need to address the question, “Are we vaccinating populations who may already have a resistance from prior exposures?”  and why?

As most know, there is no vaccine available for HCV and 85-90% become chronic infections.  For this reason HCV should be a stand-alone disease requiring a comprehensive component approach to addressing this epidemic if we ever intend to contain HCV and give patient resources that are needed. .

Good day,

T


"The secret of freedom lies in educating people, whereas the secret of tyranny is in keeping them ignorant."
Maximilien Robespierre

  

[oldhepper]

I see a lot of frustration here from both sides of the issue and from in-betweeners too.

1) The stigma attached to having HCV is alive and well, at least here in Texas (I'm native), even among health care workers. As someone who has recently experienced that particular prejudice, I'm just about ready to practice "Don't ask. Don't tell" and remind the workers to wear gloves. Seriously.

2) Medical "Experts" - read that, gastroenterologists, hepatologists - can't seem to agree on symptoms, treatment practices, side affects, etc. If they are confused, where does that leave us?

3) AARP says that many physicians gladly receive $$$ compensation from pharmaceutical companies for prescribing pharmaceutical company meds to patients. Thar is a gold mine in them there HCV people, by golly.

Meanwhile, those of us who have had the disease for decades, who are now experiencing symptoms, but whose test results indicate "normal" in all areas, are trying to live with the disease's life-impact. And, trying to not curl up in a fetal position under the covers.

No. I am not depressed. But I'm very very very tired of all of the contradictions, the politics, the prejudices and... feeling ill every morning and every evening and knowing that after awhile, a lot of HCV people just stop talking about how they feel.

[mike716]

Tell me, Merry, how do you feel about the fact that Chiron, the company that mapped the HCV genome, was granted a patent on the RNA sequence and is using it to extort huge sums from pharmaceutical companies developing anti-HCV drugs, which these companies then use as a justification for the high costs of their products? Do you believe that this is right?

[jdwithhcv]

Chiron is using its patent to "extort huge sums"???   You think mapping that genome happened for free?  Were YOU going to do it?  Can anyone develop antivirals for HCV without it?

Your reasoning leaves out the important fact that these companies operate for profit, without which their important work would be left undone.  How can you possibly argue that they do not deserve compensation?

Its not extortion, its business.  Any adult understands this concept.

[mike716]

You wrote: "Of course we are upset as patients about the costs of these drugs. It is what it is. We cannot change that."

I don´t accept that. The patenting of viral gene sequences, for example, is immoral in my opinion and a form of criminal behavior resembling that for which the anti-trust laws were originally enacted, and it would be punished by fine and/or imprisonment if ours were still a rational, truly democratic society. Likewise, using the expense of royalties and development costs as an excuse for making unjustifiably large profits is a scam.

You also said: "Ms Saly is SVR, Ms Sandt's brother is SVR, Mr. Simon's wife is stage 4, Mr Burkett and Mr. Ninburg are also SVR."; but then later you said: "Personally, I don't care who has hep C and who has chicken pox..."

Well, which is it? In any case, I never said that people working at NVHR or their family members don´t have HepC. I have no information about them personally. I can only judge them by what their organization seems to be doing. Having HepC, or having a family member with HepC, doesn´t justify all and any acts.

As to visiting a research lab, I´ve been to many. I did bibliographic research on HIV at the Pasteur Institute in Paris for five years and personally knew a number of laboratory directors there, and I know quite a lot about the morass of funding for biomedical research, as well as the connivance of government and industry for personal profit

You can call anything you don´t agree with rhetoric, Jenny, but that doesn´t make it so.

Mike

[Mr Liver]

"You only seem to focus on new INFECTIONS.  However, the issue isn't only the new infections, it's the new diagnoses of HCV. "

This is what I said: " Starting in a few years (appx 2017) the list of known HCV infections will start to plummet in the US and Europe, the two largest current markets for the pharms."

"Known HCV cases" would be those who have been diagnosed up until that appx date of 2017 when it will start a rapid decline.  And new infections is the best way to describe whether the disease has been contained, diminshed, or continues to grow, rather than using the suspected number of undiagnosed people.
ML

[mike716]

You wrote: "Pharma needs FDA approval to start making money, and this may be the last opportunity for a while to influence their actions. In particular, they've made it clear they will not cooperate on combo-tx from multiple vendors."

Do you believe, Willing, that the people who run the FDA will be influenced by the comments of private citizens, infected with HCV or not, more than by the corporate positions and share options offered to them by pharmaceutical companies as compensation for taking their side in "areas where pharma's goals (market domination) and patient goals (a cure) diverge." ?

M.

[mike716]

The granting by government of patents for genomes and gene sequences is a major worldwide political issue. You may be on the side of businesses making unjustifiably large profits (yes, that´s right, unjustifiably large profits) through the licensing of the patents they´ve been given, but please don´t pretend that there is no issue here. I am not stupid, and I don´t think the other people here are either.

You´re use of the word "compensation" in reference to what Chiron and its directors and shareholders receive as the result of having mapped the HCV genome is a distortion. They don´t need to be "compensated" as they have made no sacrifice nor suffered any damage, the only things for which "compensation" is justified. On the contrary, they were merely doing their professed jobs, for which their normal salaries should be sufficient pay. Legions of biochemists do just as good work every day, but because the results can´t be used to blackmail the pharmaceutical industry, their salary is all they do get, and not the millions (billions?) in bonuses and stock options that Chiron´s people are getting.

The system is rife with corruption. If you are someone who benefits from the corruption, you would naturally defend it.
M.

[Mr Liver]

Appx how many ppl are on the take in the pharm, medical, and insurance co's to keep all of this quiet ? Are there people at all of the major pharms taking part in this ?

How many people in total do you reckon it would take to pull off this worldwide conspiracy ?

How are they so good at keeping a secret ? Even the Mafia can't keep a secret.

ML

[mike716]

You act like you really don´t know about the "revolving door" between government and industry, about the obscene profits being made by pharmaceutical companies and their antisocial practices. Can you really be so naive? Do you think the global financial crisis is just happening for no reason? Next you´ll be saying that Enron just made a mistake.

Gimme a break.

[Proactive]

"Do you believe, Willing, that the people who run the FDA will be influenced by the comments of private citizens, infected with HCV or not, more than by the corporate positions and share options offered to them by pharmaceutical companies as compensation for taking their side in "areas where pharma's goals (market domination) and patient goals (a cure) diverge." ? "
I have quietly been sitting back and reading this thread, But jeez mike, do you actually believe half of this load of **** you are writing? My god son, you best start hunkering down, sounds like you think the pharma's are hiding in your closet. You best stock up on spam and gun powder.

[JennyPenny2009]

I think they call this "Conspiracy Theory". I thought I saw the black helicopters hovering overhead.

[HCVet]

Mike, I agree with much of your assesment The latest example... Dr. Julie Gerberding, who headed the CDC from 2002 through 2009, landed a top job with Merck, one of the largest drug companies in the world after being fired. Her job there? She's the new president of the vaccine division. HA! Isn't that a kick...

Former head of CDC lands lucrative job as president of Merck vaccine division (opinion)
Tuesday, December 22, 2009


Sources for this story include:

http://www.dallasnews.com/sharedcon...

http://www.reuters.com/article/idUS...

http://www.naturalnews.com/027789_Dr_Julie_Gerberding_Merck.html

[JennyPenny2009]

Gee, Julie Gerberding at Merck as head of vaccine development....how odd that a doctor would get that position. One of my teacher colleagues is now the Superintendent of Schools in our district. Perhaps Dr. Gerberding should have applied for that?

I just don't get it? Oh I forget, it's a conspiracy.

P.S. Just kidding around with you guys and trying to get some levity here before we all take ourselves much too seriously. Have a graet night guys.

[Mr Liver]

"Can you really be so naive? Do you think the global financial crisis is just happening for no reason? Next you´ll be saying that Enron just made a mistake.

Gimme a break. "

In other words you've never given any consideration to the number of people that would have to be involved in this conspiracy. I think we both know it would have to be a very large number.  How can you be so naive to think this many ppl could keep this conspiracy a secret ?

Do you really believe that tens of thousands of medical researchers would withhold better medicines from their families and loved ones, lettiing them in some cases to suffer and die  instead ?  Gimme a break.

Can you explain how the drug companies would know if the drugs they keep from the public really work and are more efficacious ??? Just how would they go about testing  to arrive at such a conclusion that they are betting their billions on ?

Just where do the insurance companies fit into this scam  as you claimed ? I do not see any advantage from this conspiracy to them. You really believe they would accept an arrangement where they would pay more claims for more expensive, less efficacious therapies ? You think they love the pharms so much that they'd give up profits to them for the privelige of keeping a secret that would undoubtedly lead to their decreased profits ? Insurance companies don't make any money on disease. They make it on the healthy people.

FYI about 50% of the medicines currently being marketed have their origins based in botanicals.

Instead of calling me naive and throwing up straw man arguments try answering some questions. You seem to have all the answers except those I am asking.  I will accept estimates if that helps.

ML

[HCVet]

H.I.V. Lessons Used in Hepatitis C Treatment - NYTimes.com
By ANDREW POLLACK

...some say, is that the Chiron Corporation, the biotech company in Emeryville, Calif., that first identified the hepatitis C virus, has "demanded too much money for licenses" to its patents, discouraging companies from entering the field...

..."Chiron has been a little bit like a dog with a bone," said Dr. Donald G. Payan, executive vice president and chief scientific officer of Rigel. "I think they really slowed the field down. A lot of people just didn't want to get into it." ..


So what... they get away with it? And we die in the process? I don't know what it will take to rein in such an out-of-control big business attitudes with the ability to play God.

http://www.nytimes.com/2003/03/11/health/hiv-lessons-used-in-hepatitis-c-treatment.html?pagewanted=1

[Proactive]

As Mr Liver pointed out apparently know one wants to answer direct questions.
"I don't know what it will take to rein in such an out-of-control big business attitudes with the ability to play God."
So I'll answer this one with a question, do you have any idea how much Vertex has spent so far in R&D on Telaprevir? How about Merck on Vioxx, as I recall it was $6billion and the drug got pulled...Why are drugs so expensive you ask? 2 sides to every coin.

[hopefulgirl38]

This is really interesting, although being canadian  we dont have the same struggles with access to drugs and treatments, our goverment has been at times incredibly deceivtful with respect to our health care and the role of pharaceutical companies.  even in our pubic system my partner often comments on how it is clear the drug company is running the treatment - or that they are trying to streamline his treatment for their own needs and research

[fogman]

I recently completed my wonderful trip down the pharma's road to a cure. The trip was free,and I'm undetectable, thanks to participating in a study (will not say which). I should be thankful for the wonderful drugs they gave me. However they didn't mention that it would end up messing with my cognitive functions and say..OH NO pegInfer. could not cause that... Why? then did they not disclose that information before I jumped down the rabbit hole, and still denies it to this day. See.."Dig Dis Sci (2008) 53:307-321" Cognitive Dysfunction in Chronic Hepatitis C.....

Might make someone think twice before "buying" their product. If only Dr Julie had a vaccine back in 1977.

Lets be honest here. The Pharma's are a business out to make money and tossing a little our way every now and then makes it OK.  hum brain,liver you choose. And I never used IV drug or participated in promiscuous sex. but that's what they all say....  That Mr Liver is why we need to focus on stopping this continuing epidemic, because after you get Hep you are "WAS" . and by the way I also know several Heppers that were infected just a few years ago  and they also never used IV drug or participated in promiscuous sex. but that's what they all say.
So lets focus on facts

[HCVet]

Hi Pro, good point and does account for these astronomical cost but my point is at what point do morals/ethics come into play... Chiron got this patent off the backs of tax payers in collaboration with the CDC. Then we were held hostage:(  Fair? life's not I realize that, but it certainly is not right to hold the only key to our lives and ask for so much money no one can afford it, while revenue rose 12 percent to as sales increased in all product lines.  

I think, as a society, we can do better. Reminds me of that James Bond movie staring Tom Cruise. Can't think of the name...

[HCVet]

hopefulgirl writes- our goverment has been at times incredibly deceivtful with respect to our health care and the role of pharaceutical companies.

Dr.Marcia Angell, stepped down as editor of the New England Journal of Medicine, worried about the effect the coalitions could have on people's faith in public-health campaigns.  Schering's role "underscores for me the fact that drug companies cannot be in education," she said. "They can't because it's a conflict. Their primary mission is to increase the bottom line for shareholders." http://march-on-dc.com/CDC/Trail/grassrootsdrugmoney.html

I think its a globle thing hopefulgirl

[desrt]

Poor hard-working-genome-mapping Chiron. Chiron wasn't the first to identify or isolate HCV. They were merely the first to clone it, which is all it takes to establish a patent on a disease under international patent law. And the plasma their HCV was cloned from was provided by an American scientist working for the CDC.Your tax dollars at work
http://lists.essential.org/pipermail/pharm-policy/2000-October/000385.html


http://hepcproject.typepad.com/hep_c_project/2004/06/chirons_hepatit.html
" Chiron holds over 100 patents related to the HCV genome, which won't expire until 2015. Any company that develops a new drug targeting hepatitis C (such as a protease inhibitor), or a diagnostic test to detect and measure HCV (viral load; test for screening the blood supply), needs to license Chiron's patents, typically by negotiating a licensing fee and royalties on product sales. Chiron typically charges each company millions of dollars in licensing fees during research and development alone, and makes millions more each year in royalties from HCV tests."

Ever wonder why a sensitive PCR can cost upwards of $500?

[eureka254]

On the flip side, consider that it was Chiron's capital in 1987 that allowed Drs. Houghton and Alter to bring to market the first hep c antibody screen.  Prior to that point, the countless millions of new hcv infections via transfusion were seemingly unpreventable. I do not defend Chiron's position on patent rights, but Chiron has played (paid?) an essential role in the virtual elimination of hcv in our donated-blood supply, and I for one do not see that as an obscene use of my tax dollars.

I see it as a matter of "pay me now or pay me later" -- i.e. we can pay Chiron to help us from getting the virus, or we can pay Schering or Roche to get rid of it after we're infected.  Pick your poison.  Or, we could always choose not to invest in pharma at all, and find other means to consistently and sufficiently fund research for hep c to develop vaccines, cures, etc... ideas, anyone? Does anyone think we might get overwhelming public support and funding like Congress got for universal healthcare? ~eureka

PS:  BTW, I don't believe either Dr. Alter or Dr. Houghton have hcv, but I would not hesitate to have either one of them sit on any hepatis c voting board/panel/round table.

[Proactive]

Hi HCVet,

"at what point do morals/ethics come into play" I suspect this is a question that has it's origins going back to the dawn of time..I know how to make fire, do I share it with the world (my competitors for food, my enemies, my friends) or do I capitalize on the knowledge for personal gain (food, protection, procreation)
I sometimes think that many overlook many of the expenses and risk involved in bringing a drug to market( especially a niche market such as hcv). I probably sound like I am defending the drug companies, but really I'm not. Just trying to show the flip side for sake of argument.
I stumbled on to this article, while it may be a bit off target, it does illustrate the R & D and risk/reward management culture prevasive in the pharma industry.
http://www.allbusiness.com/company-activities-management/management-risk-management/14156815-1.html

I also wonder why the contemp for drug companies doesn't seem to apply to the shareholders of those companies.
In reality, if one is in a pension fund, mutual fund, owns an insurance policy oron and on, they are infact an owner of a piece of a pharma company. That said shouldn't we depise the individual (our neighbor, spouse, children) just as much as the corporation?

[HCVPETE]

Thank you for your thoughtful comments and welcome to the big, diverse, happy dysfunctional family that is the HCV patient community.
There is good reason conspiracy theories find such fertile ground among HCV patients. For this patient, the issue is not so much the market functions of big pharma, HCV treatment, and how it impacts patients, but it's insinuation into patient advocacy. I challenge anyone to find a patient rep within the NVHR that does not personally or organizationally benefit from pharma funding. All the mainstream HCV advocacy orgs - no need for naming names here - are pharma funded. And the same old voices - you hear them here - that benefit financially from them are their biggest defenders.
HCV advocates should take a cue from the HIV/AIDS community. Before they formed partnerships with pharma, AIDS activists demonstrated against them. Disrupted pharma functions. Demanded better, less costly, treatment. I dont see that happening with the current crop of pharma funded advocates within the NVHR, many of them recycled AIDS activists. They are a disappointingly passive, if well intentioned, bunch.
And we have ourselves to blame too, for not being more aggressive in fighting for a fairer share of public funding. For letting others do for us that which we should do ourselves.
Until I see more patient diversity and independent HCV advocates within the NVHR,  I'm not ready to trust it or their patient proxies.

.

[HCVPETE]

As a point of clarification.. There is one patient rep of a major organization within the NVHR that has never got pharma funding.
That would be me....

[HCVet]

Pro writes- I also wonder why the contempt for drug companies doesn't seem to apply to the shareholders of those companies

Hi Pro, That's part of how we eventually got Chiron to ease up on it's patent cost.

Many grassrooter's worked with the KC Star on its series. We first started pounding Chiron in the mid 1990's with the unfairness.  I think shareholders have a tendency to not care where all that profit is coming from until its put in thier face. It's just the way we are today... I call it tunnel vision, LOL

But, the KC Star article really helped. Back then every major media, including News Week, wrote on our behalf. Folks were getting tested from all over the country due to grassroots efforts. So much so,  the CDC changed the case definiton to better define acute, as not to waste resource to identify outbreaks.

For those reading this, acute/new infections are defined when a patient is HCV positive with elevated liver function tests for 6 months. Over 6 months is considered chronic.

Now... . The 2007 Case Definition Modification has raised these standards defining acute as ALT levels > 400 IU/L Way too high!!!

We really praised the IOM report that recognizes these standards are not always applicable.   Prior standards considered testing anyone with elevated ALT that were 7 times the norm. So here's the problem

Men Normal High 30-60 IU/L
Women Normal High 19-38 IU/L

When you do the math... can only wonder how many aren't identified... Most cases of HCV are asymptomatic and very seldom diagnosed in acute stages to begin with.
I'd like to see NVHR take up this issue but my guess is NCHHSTP will have no part of it. Time will tell and as usually patients pay the price:(

Well, as you can read, I wondered off post... LOL, Sorry... I'll check out that link.

[HCVet]

Hi HCVPETE, good for you... ALF takes 5% funding from the pharms, which I guess is acceptable. Guess there's no harm as long as it doesn't control the agenda.

Seems our community is broken in three branches- Grassrooter's can not stand with ALF, as we felt money was being made off our backs thru support groups that pushed TX, and then profits used on all other liver disease. ALF does not reveal just what they spend it on publicly. But when we pushed... learned that fact.

Can't change ALF and can't change NVHR... seems we're stuck between a rock and a hard space.  And as usual, on our own to make sure patient needs are met.

Thanks for having a voice and all the great work your org does. Wish we had more advocates like you:)

[willing]

Mr.L's point about lack of government funding for HCV is quite valid - as an epidemic it's been in decline since screening of the blood supply started. However there's really three different patient populations with respect to HCV: those not infected but at risk, for whom vaccine development is key; those trying to rid themselves of  a chronic infection and those SVR or not, who are dealing with consequences of long term infection (cirrhosis, hcc, end-stage, etc.). Like the newly infected, the  2nd group is also shrinking. Though there's still a lot of us, it's pretty clear the ability to eliminate chronic infection in essentially all will be routine within 5 years.

The (lack of) resistance for r7128 looks very good. Once that, or equivalent can be coupled with an NS3 inhibitor like telaprevir/boceprevir *and* existing SOC/NTZ the subset of untreatable chronic infections will shrink to  a very small group. All these meds are available *NOW* thus the number of people who will  progress to more extensive liver damage because of delay  directly depends on how the FDA  controls access during this interim stage.  The FDA, like all regulatory agencies, is not perfect. Nevertheless, they are explicitly soliciting patient input at this time and it *is* a chance to influence their decision (Mike: yes, I do think the FDA is interested in patients, and that the  Roche board of directors is very interested in what the FDA rules)

the other two patient groups will be much harder. Vaccine development is not yet in reach (here's a recent summary)
http://www.ncbi.nlm.nih.gov/pubmed/19529757
and the prospects for reversing fibrosis or controlling hcc also seem distant.

BTW, there's a good summary of HCV discovery,  by Houghton, the lead Chiron scientist among the HCV dart presentations.
http://ihlpress.com/gaj_hepdart2009.html
Look for "The long and winding road leading to the discovery of the hepatitis C virus ( HCV )". It was an impressive bit of biology. Bradley, from the CDC, is clearly acknowledged in terms of scientific contribution. That the gov and Bradley signed away their share and didn't get any of the money seems to come down Chiron's patent lawyers.

[willing]

here's another good background piece by Lisa Davis on the Houghton-Chiron/Bradley-CDC story which seems to predate the KC piece by a few years

http://www.sfweekly.com/1998-03-11/news/viral-combat/1

all ancient history now, but timely since Merck/Vertex/Roche are on the verge of major money.

In support of conspiracy theorists,  it's interesting that a decisive role in the Chiron - CDC negotiations was played by Joseph Califano, former HEW head and cabinet member, hired by Chiron (even the paranoid have real enemies).

[Trish77]

"Mr.L's point about lack of government funding for HCV is quite valid - as an epidemic it's been in decline since screening of the blood supply started. However there's really three different patient populations with respect to HCV: those not infected but at risk, for whom vaccine development is key; those trying to rid themselves of  a chronic infection and those SVR or not, who are dealing with consequences of long term infection (cirrhosis, hcc, end-stage, etc.). Like the newly infected, the  2nd group is also shrinking. Though there's still a lot of us, it's pretty clear the ability to eliminate chronic infection in essentially all will be routine within 5 years."

I don't see that any of your three groups adequately cover the group that is only now discovering that they have HCV at all.  Statistically, this group is not at all shrinking.  This group is increasing and is expected to increase until around 2024, thereabouts depending on which statistic you read.  New infections on the decrease, new diagnoses on the increase.  

I'm assuming you're thinking of the new drugs on the horizon when you say that the ability to eliminate chronic infection will be routine within five years.  I suspect that improved knowledge on the part of the medical community in properly treating those with Hep C will not keep pace with the entrance of the new drugs onto the market.  We see this even now.  Great to have these new drugs however those with Hep C are still and will still somewhat be at the mercy of a medical community that still has a long ways to go in improving it's methodology and treatment practices to properly care for those with Hep C.

[merryBe]

hoo hoo hoo yowzer...go away a while and looky looky looky...

see now this is some interesting stuff...

hmmm....should a salary be sufficient, if we want to have capitalism rather than communism but that's another discussion, otherwise we have to consider that anything a person invents or patents carries a certain right to profit with it. Time limits on patents ensure that the public will benefit as well, but the seven year profit protection has a point...it allows for tremendous risk and innovation to occur.
People take risks that are rare in countries without such laws.

Perhaps this system is why we have produced 90% of the new medical breakthroughs while having 1/2O th of the worlds populace...I don't know. It seems our system has it's up and down sides. Goota love it, warts and all.

It's like asking Bill Gates, hey how come you didn't just stay content in your dad's garage...in the end, most of those billions go back to people, he can't take them with him...should he have been able to profit...that's really your question...certainly more folks would have computers if not for the cost he extracts...my question is...if you spent years of your life working on something, risking your home, your retirement, everything....would you want to profit or not from that? Does building a company that then does more research and more good not have it's merits...hmmm

as to epidemic gone....what?......NOT TRUE....hcv WAS going BACK down and is now going UP again, chiefly due to young folks getting tatoos...THEY KNOW ABOUT CLEAN NEEDLES NOW, and are clueless and in denial about what can come from a tatoo parlor.

current stas include 170,000 million worldwide, another 500 million with hbv...
rates are expected to climb and may be as high as one in every 2 people in 10-20 year depending on who you ask. My clinic is gearing UP not down, based on these projections.  We already have 1 in every 7 or 8 people with one form or another...and the latter form, hbv is highly contagious...highly.

this is not like HIV, where once the behaviors that spread it were learned the infection rate went down....this is different....tatoos are on the rise, name one young person or sports figure in the public eye not adorned with them...and hygiene is still very poor in much of the world.
My clinic says 90% of the immigrants coming in are carriers....and they are ending up in service industries such as restaurants...meaning rural uneducated immigrants are going to infect the rest of us.
It helps to go abroad to realize why immigration is a problem...there are still many areas where electricity doesn't exist, where sewers are open troughs and where hand washing is non existent.
I had a friend who rented to a group and I cannot write what happened to that apartment, it's too aggregous to put in print.
We had to stop going to certain restaurant when we learned the violations included chopping foods on the floors...a common things in parts of the world, it is frown on here...so I gave up my pension for certain cuisines...we  can choose to ignore such info when it comes our way,...but to our own demise I fear.

mb

[willing]

yes - no argument on either point. I'm lumping diagnosed/undiagnosed chronic together which bypasses the question of how to identify the chronically infected. However the technology for that is nearly 20 years old, so failure to screen is a policy decision. As I recall correctly, here in the US a few years back a decision was explicitly made *not* to routinely screen for for HCV Abs at the outset of ER intervention etc. - maybe that will be changing soon. What's the policy in Canada?  

And yes, Dr. confusion will be rampant for quite a while. Guidelines for how to mix an optimal  anti-viral cocktai are going to take a long time to evolve. My point was only that the FDA can prevent a lot of progression and damage by opening up access for multi-vendor   polymerase+protease+soc tx to those most in need - rather than limiting this to the trials Roche and Vertex think are in their best interest. ( which seems to be  the question they are requesting comments on).

[Trish77]

No routine screening in Canada either.  I think there is a reluctance to take that step as we clearly don't have the resources required to treat the numbers of people they suspect are as yet undiagnosed - we hardly or don't have the resources to adequately treat the ones we do have but we do what we can.  (How they come up with the 30% or so number has always been a bit of a mystery to me.  Any insight on that?)

"My point was only that the FDA can prevent a lot of progression and damage by opening up access for multi-vendor   polymerase+protease+soc tx to those most in need - rather than limiting this to the trials Roche and Vertex think are in their best interest. ( which seems to be  the question they are requesting comments on)."

I've been reading your posts about that.  I'm very very interested to see what comes of that.  While what happens in the U.S. is not automatically repeated in Canada, it does at least set some kind of stage for the same kind of progress here ... at least, I'd be hoping so.   I wish you all success with that, for your sake and for everyone's sake with Hep C.  Interesting times.

Trish

[HCVet]

Here's the latest
The ruling came in a long-running fight between scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward. It was almost sure to be appealed to the 2nd U.S. Circuit Court of Appeals in Manhattan.

Wonder what this means for Chiron? Dare we hope?

US judge strikes down patent on cancer genes
March 29, 2010 11:03 PM EDT
NEW YORK (AP) — In a ruling with potentially far-reaching implications for the patenting of human genes, a judge on Monday struck down a company's patents on two genes linked to an increased risk of breast and ovarian cancer.

The decision by U.S. District Judge Robert Sweet challenging whether anyone can hold patents on human genes was expected to have broad implications for the biotechnology industry and genetics-based medical research.

Sweet said he invalidated the patents because DNA's existence in an isolated form does not alter the fundamental quality of DNA as it exists in the body nor the information it encodes.

He rejected arguments that it was acceptable to grant patents on DNA sequences as long as they are claimed in the form of "isolated DNA."

"Many, however, including scientists in the fields of molecular biology and genomics, have considered this practice a 'lawyer's trick' that circumvents the prohibitions on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result," he said.

The judge said his findings were consistent with Supreme Court rulings that have established that purifying a product of nature does not mean it can be patented.

He said the company deserved praise for what is "unquestionably a valuable scientific achievement," but not a patent because the "isolated DNA is not markedly different from native DNA as it exists in nature."

The ruling came in a long-running fight between scientists who believe that genes carrying the secrets of life should not be exploited for commercial gain and companies that argue that a patent is a reward for years of expensive research that moves science forward. It was almost sure to be appealed to the 2nd U.S. Circuit Court of Appeals in Manhattan.

Last March, the American Civil Liberties Union and the Public Patent Foundation sued Myriad Genetics Inc., based in Salt Lake City, the University of Utah Research Foundation and the U.S. Patent and Trademark Office.

The ACLU and the patent foundation said Myriad's refusal to license the patents broadly has meant that women who fear they may be at risk of breast or ovarian cancers are prevented from having anyone but Myriad look at the genes in question.

Myriad attorney Brian Poissant declined to comment. At a hearing before Sweet last month, Poissant said disallowing the patents would wreck the foundation of the biotechnology industry.

Chris Hansen, one of the lawyers who argued the case for the ACLU, said the ruling provides a "strong advance for women's health and for science."

He said the ruling, if upheld, would threaten many of the patents held on approximately 20 percent of the human genome.

"In our view, it would enormously increase women's opportunities to receive testing and diagnoses and would liberate research opportunities for researchers all over the country," Hansen said.

Yusill Scribner, a spokeswoman for lawyers who argued for the U.S. Patent and Trademark Office, declined to comment.

Testing for mutations in the so-called BRCA genes has been around for just over a decade. Women with a faulty gene have a three to seven times greater risk of developing breast cancer and a higher risk of ovarian cancer.

Men can also carry a BRCA mutation, raising their risk of prostate, pancreatic and other types of cancer. The mutations are most common in people of eastern European Jewish descent.

Myriad Genetics Inc. sells the only BRCA gene test, which one expert says now costs nearly $4,000.

"There are some women without insurance coverage who are not able to pay that," and have not been able to be tested, said Dr. Kelly Marcom, a breast oncologist who runs Duke University's Hereditary Cancer Clinic.

Some doctors and researchers contend that this monopoly has long held up not only competing, cheaper tests but has also hindered gene-based research.

"The evidence has mounted that human gene patents are doing more harm than good," and resulted more by accident than a well-thought-out policy, said Jesse Reynolds, a policy analyst at the Center for Genetics and Society. The center is a nonprofit policy research group advocating for oversight and responsible use of biotechnologies.

The Myriad patent "was particularly troublesome" because it was so broadly worded, Reynolds said.

Reading the court ruling, "I saw nothing that limited it to Myriad's patents," Reynolds said. It boiled down to this, he said: "Natural things aren't patentable; inventions are."

"This has the potential to dramatically shake up the biotech industry," Reynolds said.

___

AP Medical Writer Marilynn Marchione in Milwaukee contributed to this report.

___

On the Net:

National Cancer Institute: http://www.cancer.gov/cancertopics/factsheet/risk/brca

FORCE support group: http://www.facingourrisk.org/index.php

[mike716]

Thanks for the news clip. I'll bet it gets struck down on appeal. But if it is upheld, the legislature will probably pass a law getting around it.

The Department of Justice, if it really were such, would have used the anti-trust laws to stomp on the genome patenters' toes years ago. Unfortunately for us all, the DoJ has filled up with third-rate lawyers who, like their brethren in Congress, are likewise playing the revolving door game. Until the Constitution is amended to prohibit public office holders from accepting employment in industries allied to their public control functions, and a permanent, independant congressional anti-corruption committee created with wide-sweeping punitive powers, there will never be an end to corruption in government.

I was brought up with the idea that one the chief function of government in a republic was to protect the public-at-large from the depradations of business, especially big business. Our government seems to serve the opposite purpose: to protect big business from the public.

Sooner or later people are going to get fed up with being cheated. I believed it would happen during my lifetime, but I guess history moves more slowly than I thought. And I underestimated the power of the media to convince people to remain victims, or to betray their own best interests.

However, the fight goes on. The purpose of science and learning is to better the lives of the majority, not to make a few people rich. And the purpose of language is to communicate the truth, not to lie and cheat. The few may pretend otherwise, but the many will now what's right.

At least I hope so.

M.

[willing]

not sure whether that ruling (if appealed and upheld, as it hopefully will be) will have any bearing on Chiron , whose patent is on  hcv rna, not human. However it may impact the current application from McHutchison/Schering for a patent on the IL28B SNP ( rs12979860 ). This is the chromosome 19 variation that was recently found to largely account for whether one is/is-not ifn-responsive:
http://www.ncbi.nlm.nih.gov/pubmed/20176026

Last time I looked, the 23andme personalized dna sequencing service did not test for this snp but I don't know whether they just haven't set up for it yet (the initial nature article only came out last year) or are avoiding doing so because of the pending patent.

This may well be another area for pharma-patient conflict. Checking whether one will respond to ifn, eg in cleaning up resistance to 1st gen PIs, will presumably become a key part of planning tx from here on - it would be unfortunate (criminal?) if the Schering/Merck patent stopped/delayed people from reading their own dna.

[eureka254]

The article is erroneous on at least one count.  It states "Myriad Genetics Inc. sells the only BRCA gene test..." , which is patently untrue.  

As willing points out, comparing viral rna and human dna is like comparing apples and oranges. Testing methodologies are certainly patented, but trying to patent human genome sequences would be like trying to copyright something you read by paraphrasing it.  

[HectorSF]

Too funny!

So many FACTS so much misinformation...he,he,he

By the way, those bad people who "discovered HCV" remember the good old days of "non A, B hep"? Where would we be if Chiron or another one of the evil empire pharma companies hadn't been able to identify the various hep virus? There would be no treatments at all. (!!!) Is that what we want?
By the way Chiron was sold 4 years ago and is now part of Novartis. Doh!

We are so self righteous. I didn't realize we had so many people on this forum who are ESLD. The Pharma companies are trying to kill us. Really? So who else besides myself is stage 4 and starting to decompensate??? Ascites, edema, hepatic encephalopathy, etc. Is a non responder but not sick enough for a transplant? Can I see a show of hands. I've been feeling quite lonely lately.

As far as funding for HIV. Does anyone recall "Act Up" and all the organizing that the gay community did for years and years when our President would even say the word AIDS!? They got organized and refused to take no for an answer. That is why they have the funding they have. Besides where do you think the new antivirals come from? From the work that has gone into AIDS research and the development of HIV antivirals.

Seriously folks. Where can I get a job based on my good looks that will pay all my bills. I don't want to corrupt my pure self (except for my corrupted, diseased liver, or what is left of it) with evil capitalist money like those nasty corrupt pharma companies? I prefer work here in the Bay Area. Hey, maybe in the "Republic of Berkeley"? I can email you my resume...

I mean this conspiracy stuff is funny but I think we should leave it to the professional right wing haters. At least they get paid to rant. (I hope not is the evil U.S. dollars though). ;-)

Peace, Love & Understanding to all. (Even the haters)
Cheers!
HectorSF

[mike716]

Hi, Hector. You wrote: "who else besides myself is stage 4 and starting to decompensate??? Ascites, edema, hepatic encephalopathy, etc. Is a non responder but not sick enough for a transplant?"

It seems to me that, as a non-responder, you would more naturally be angry that there aren´t more effective drugs, instead of upholding the status quo.

You also wrote: " Where would we be if Chiron or another one of the evil empire pharma companies hadn't been able to identify the various hep virus?" What do you mean by "the various hep virus"? I thought Chiron sequenced hepC virus; and we would probably be in exactly the same place we are without Chiron, since interferon and ribavirin Tx is not based on the viral genome, indeed they have nothing to do with it, and were not developed as a treatment specific for hepC.

You say: "They [AIDS militants] got organized and refused to take no for an answer. That is why they have the funding they have" That is precisely the argument of this thread, that hepC infectees should organize and exert political pressure for a new and better treatment.

M.

[HectorSF]

Mike-

I don't consider myself as upholding the status quo. Maybe I'm more conservative than I thought. At least not politically anyway.
Yes I do believe my best hope of continuing to live is by working with my supportive doctors and taking care of myself physically and mentally. But I also realize my liver could fail at any time or I could develop HCC at any time. I can't control those things so I concentrate on what I can control. I figure what other options do I have?

As far as the point I was try to make about Chiron, I meant that if Chiron or some pharma company hadn't identified HCV how could we know if we had HVC (the first step to developing treatments) and not some other "non-A, non-B hepatitis virus such as D and E. Besides once HCV was first identified in 1989, tests were developed to detect the virus in blood before people had transfusions. As a result, since the early 1990s transfused blood is not a common cause for the transmission of hepatitis C. (Talk about people who have a reason to be angry). That alone saved thousands if not 10s of thousands of lives. I don't see that as anything but a good thing if I have to put a judgment on it.

You say: "They [AIDS militants] got organized and refused to take no for an answer... That is precisely the argument of this thread, that hepC infectees should organize and exert political pressure for a new and better treatment.
I couldn't agree more with you on this! I write my congress people regularly and have advocated for more support for us heppers during the development and passage of the new health bill. I found found a lot of support from the medical community here in the Bay Area and and happy to live in such an enlightened part of the country.

As far as if my post makes sense or not, that is up to others to determine.
I did try to express my point of view based on my own personal experience with HCV and liver disease. My experience and conclusions are only that. And yes I was making light of the contentiousness of some of the postings.
Sometimes I feel the need to laugh as there are other times when I can only cry because I'm frightened about what is happening to my health and life. I'm only human. The good, bad and the ugly. We are all managing as best we can. Yes I get angry at times too. I try to use that anger to do something positive with it. Negativity, at least for me, at this point of my life is not helpful for me. Maybe I'm weak but I need positive thoughts and actions to give me hope. Without a belief in the future and appreciation of all the good things I have had and have in my life I can't see how I can go through this suffering.

Sorry if I offended any one. I didn't mean to offend anyone personally. All I know about others on this forum is that a number of people have been helpful to me with information or encouragement which I have found helpful over the years. I think members understand how much I've appreciated their support. At least I hope so.

Yes I was making light of things on this thread as my way of letting off stream. I didn't mean to have my need to let of stream step on anyone elses toes.

Thanks for letting me say my 2 cent worth.

HectorSF

[katman78070]

absolutely excellent article mike. its always been about the money. for proof of this m, turn on the so-called business , stock market, government, fascist media mouthpiece organ any day of the week, and see how many times they talk about what some drug company is doing to try and generate profits. also if you will notice anytime they advertise a drug on the boob toob, it takes them 5 minutes to tell you the side effects, and i for one, cannot figure out why any living human being would so much as dare to take the drug being advertised. it is insane. but anyway i digress. something good is bound to come down the pike soon , one can only hope. i made up my mind when i was told that i had hep c (during a routine blood screening at the va hospital in san antonio) that i would not undertake the awful chemotherapy that they try and push on people. i am not interested in being poisoned, i am not interested in being stuck nor am i interested in being burned etc. such is american medicine these days, sad but true.  no wonder doctors are no longer required to sign a Hippocratic Oath. they say to themselves, well i am good. i have a job. i can feed my family. so what if a lot of the things i do are not ethically correct. so what. i am well. my family is well. my world is secure. i am getting paid. all is well in my world. such is life in amerika in this disaster known as the american medical establishment.

[katman78070]

the trouble is hector, that Chiron Corporation, was never able to identify what if any virus is causing this thing called hepatitus (hepatitis) c.  of course they said they did and tried to prove it. and around these bogus findings arose many financially lucrative pathways for other drug companies who then came up with interferon and other overly expensive crap.

[Dee1956]

Thank you for starting this thread, very interesting
Dee

[mike716]

Yes, it's a good thread, and still the fundamental political issue regarding HCV research and funding.

M.