So, we now know that a residual and potentially toxic soup of pharmaceuticals is in the drinking water of cities across the country.

Many pharmaceuticals, we can safely assume, are contraindicated for those with liver disease.

People with undiagnosed (and diagnosed) liver disease drink in this water over years.

We wonder why their liver disease advances. Maybe it’s time to think outside our environmental box and see that the human liver and the environment are entwined?

Teresa Hanbey
 

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http://www.lasvegassun.com/blogs/ralstons-flash/2008/mar/07/states-epidemiologist-speaks-out-health-scare/

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 This is a blog from www.bizmology.com For links and comments, please visit bizmology and tell Kristi what you think of all the “off labels” marketing that has been going on all these years in the hep community, where the treatment has risks for those with underlying heart problems. Kristi is my nominee for hepheroism of the week.

Another round of questions about Amgen’s anemia drugs

by Kristi Park, March 10th, 2008, 5:28 am

The stakes couldn’t be higher for Amgen this week, as it prepares for yet

 another FDA hearing on Thursday related to anemia drugs Aranesp and Epogen. The two drugs, as well as one sold by Johnson & Johnson subsidiary Ortho Biotech under a license from Amgen, have spent the past year under fire from the scientific and medical communities, and the questioning doesn’t seem likely to stop any time soon.

The drugs are known as erythropoiesis-stimulating agents; they are bioengineered proteins that stimulate red-blood cell production in cancer patients taking chemotherapy or people with chronic kidney disease. (Both classes of patients commonly experience anemia.) And they are blockbuster products, prescribed to some 4 million people since they’ve been on the market and generating a combined $9 billion for Amgen and J&J in 2007.

Problem is, numerous studies published over the last 18 months have questioned the safety of the drugs, especially when used at high doses. Those studies have suggested that Aranesp, Epogen, and Procrit (the Ortho Biotech version of the drug) increase the risk of heart attack, stroke, and death, and even possibly the more rapid growth of tumors in cancer patients. Not good.

Amgen and Ortho Biotech revised the labels on the drugs in 2007 to reflect these risks, but since then, more studies have come out underlining the drugs’ dangers. And so the FDA advisory committee that specializes in cancer drugs has called another meeting to decide their fate, at least in relation to chemotherapy-induced anemia. Several analysts told Bloomberg they expect the FDA to place further restrictions on the drugs, with a slim possibility that they’ll recommend Aranesp and Procrit not be prescribed for cancer patients at all.

Although any bad news coming out of the Thursday meeting will hurt both companies, it would be far more devastating to Amgen, which depends on Aranesp and Epogen for more than $6 billion in sales, about 40% of total revenue. (J&J is obviously far more diversified but still gets about 5% of its revenue from sales of Procrit.)

Amgen has already gone through a round of lay-offs and restructuring in response to lower sales of the drugs, and the company’s stock price has suffered mightily. Both employees and investors will no doubt be paying attention to what happens Thursday. Stay tuned

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I am heartened that the FDA is cracking down on practices related to drug approvals (you know, looking behind the curtain of so-called “research studies.”) and direct to doctor and direct to consumer marketing. I hope it is the harbinger of things to come.

Now comes Mr. Jarvik. He does not know how to row a skull, he is not a cardiologist, and he is not a licensed physician. His ad is being pulled because it is full of ethical issues (lies) He is the tip of the proverbial iceberg. When it comes to pharmaceutical marketing, where you get the information about treatment, choice matters. It also matters who your provider is relying on for information as well. And while television is the least of it, it is what people see.

Pay attention to celebrities who make claims about what drugs they take. You can’t check because their medical information is protected by law. Bear in mind these are PAID actors. Sure, mom or dad may have had so and so disease. MAY have had, or may NOT have had. I have yet to see a celebrity step forward, unpaid, and take on hepatitis  prevention. We have been approached to represent the treatment end by celebrities, as all have. But, we have no money to pay someone to talk about hepatitis C  and they have no real committment to prevention, so it didn’t work out. Selling prevention is really, really hard. So many community members have said that if only a celebrity would come out and speak for this community….

So many doctors are trained by drug reps (who are not doctors, are usually a young female in a black suit and nice to have a free lunch with) and nearly all of the conferences doctors attend are supported by the pharmaceutical industry, it is truly difficult to know what, or who, to believe. I wonder if they even ask themselves, or are they there for the free food?  Did Jarvik? Why do they have all those brochures and fancy posters, seminars (repeat after me: honorarium) in their waiting rooms? Because they are FREE. Otherwise, they might have to TALK to the patient.

How many doctors have donated to our organization?  There have been a few. Mostly, they donate to the foundations (distinct from a charitable organization) with the money to host the fancy parties, “support groups,” newsletters, fundraisers that pay researchers to research the same drugs we know don’t really work. Mostly, foundations and organizations talk to each other and seldom do outreach to other disciplines or groups. This is what we would like to facilitate more of. 

The National Institutes of Health convened a Consensus Management conference on Hepatitis C in 2002. Not one hepatologist could serve on the panel due to conflicts of interest. Did it really make a difference? Most of the presenters were people with some form of tie to the pharmaceutical industry and these presentations formed the basis of the recommendations. Our 3 minute presentation advocating for routine testing is on video somewhere at the NIH but it didn’t make it into the book or meeting summaries. Our volunteer medical director gave the presentation.

It never ceases to amaze me how few doctor have developed critical thinking skills that allows them to connect the dots. Instead I see them with silly cowboy hats on at AASLD parties, accepting drinks from young women dressed as champagne glasses, complete with bubbles made of balloons on their heads. No kidding!

Even the reputable “foundations” are reliant on this same pot of gold. The American Liver Foundation, for example, is the “fundraising arm” of the American Association for the Study of Liver Disease which funds research. The American Association for the Study of Liver Disease is the scientific arm and publisher of the peer reviewed journal Hepatology (the creme de la creme of liver journals)  They also are the hosts of the yearly AASLD “liver meeting” which presents the latest in the “science” regarding liver diseases. Very prestigious to both doctors and patients. At one time, to me too. Until the dots are connected and it leads you behind the curtain at the end of the gold brick road. And you see the same cast of characters at every function and they become a very small circle of people who admit in private what they would never say in public.

The cash cow for several years running has been the treatment for hepatitis C, along with the courtship of the HIV community via HIV/HCV co-infection for the influence and political power that community has come to enjoy. Saavy, smart and well educated in the ways of balancing threatening and back scratching pharmas into submission.

Doctors, particularly gastroenterologists rely on information from these meetings and the journal, as do many policy makers and others. The hepatologists, though mostly university professors, are “jarviks.” They are spokespeople on a higher plain, directed at the medical community. But, it’s the same dynamic. They bring  in the research dollars, get their names in the journals, have status and then become the medical director of a Pharmaceutical company. Sometimes, it is all simultaneously juggled. After all,  it completes  the image of authority.

 Marketing or science? This question has been one I have repeated many times. It’s one that every  medical professional should be asking: is this a medical expert or a drug company spokesperson?  I admit my guilt, too. The only serious funding for organizations such as HCOP  is pharmaceutical money. Or, pharmacetical assisted giving, as I call it. 

Pharmaceutical companies fund pass through grants for specific organizations, thus making it seem to be coming from a different source. This organization has been given small grants once in a while. We have relied on diagnostics money to keep the doors open as this is the basic message of HCOP: get tested. This does not present an ethical dilemma. They have never, not once, asked for quid pro quo. Patients contribute in many ways. It all matters.

It has also lead to running an organization primarily out of my own pocket, which I cannot do for much longer. But I can use the internet.

Same issues are a concern for the off label prescriptions for treating the side effects of a largely ineffective and, potentially dangerous “cure.”  Is this safe?

After all, the vast majority of those with hepatitis C are African Americans with genotype 1.   Treatment success rates are dismally low in this group. And, my efforts to get the attention of the African American community to emphasis prevention has been a complete failure.

The CDC continues its efforts to assure us that IV drug use is the major risk factor. This in spite of years of evidence to the contrary. So, what’s the message there? Where hepatitis C is concerned the CDC (and P?) has been a total failure at control or prevention. But, there they are, presenting at the “liver meeting” and partnering with the pharmaceutical industry to educate you and your doctor about hepatitis C. I’ve done it. I have been part of the machine.  I have paid out honorariums with pharmaceutical money. And, I have received money, too. 

It’s good for the economy but, is it good for you? Ask your doctor AND do your own research. Your doctor does not have the same amount of time and investment in your health that YOU do. And, doctors rely largly on journals and CME seminars for their information, which are funded by….yup, you guessed it!

For those with hepatitis C, this is a particularly important point: how many times have you seen this, or some variation of it, on a TV commercial for a drug? “Tell your doctor if you have liver disease.  Xyz should not be taken by those with liver problems. Tell your doctor if you suffer from liver problems.”

 Isn’t your doctor the one who should be telling you?  Symptomless liver disease, which is very common at every age including (and maybe, particularly) obese children, is not diagnosed without testing for it in advance of prescribing a medication.  That failure could result in liver/heart or other serious or fatal complications. Has your doctor tested you for  hepatitis, which is often symptomless? 

Really, you cannot take anything for granted in business. And healthcare is big business. 

Feel better?

Teresa Hanbey

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I, finally, have more company after 15 years of blowing the whistle about hepatitis C in young people.

Anyone who wants to check on my repeated attempts to draw attention to this can easily do a google search or just ask anyone in the field. It has been an elephant in the room since the beginning of any awareness of heptitis c. This epidemic is multifaceted, risk-wise, and those at risk are not the same group as those being diagnosed. The older generation of patients have been the canaries in the mine. But, instead of learning from the evidence we have, this seems to only be impetus to continue to look at the canaries and not the mine.

 Our message has always been GET TESTED. It opens the door to so many options, protecting self from progressing liver disease, preventing transmissions to others, and the will for this message to get where it absolutely needs to be: in schools, colleges, even primary grades (we have a fully prepared slide set for elementary school made for school nurses and disseminated since 1999)

We have talked about regulating the tattoo industry to make tattooes safer (we do not seek to ban anything; just make it safer) I, personally, have made a presentation with Robert Haley in 2000 to the American Public Health Association in Atlanta and have been invited to make another in 2008. We worked with the University of Wisconsin’s site, whyfiles.com, to put together the information on tattooing and its risk. Then, a new study was presented that found tattooing to be absolutely associated with the practice of commercial tattooing. 

So, now that the evidence is approaching critical mass, what are we going to do about this?

I know, I’ve been asking, begging, for a long long time, but it is never too late to join us and ACT on the information. After all, information is useless until the right people have it and can make personal decisions (and policy decisions) based on it. We have provided postcards to women’s health clinics this year (OHSU and the VA ) targeting young women and their mothers. We could not keep up with demand! Funds were generously provided by Roche Diagnostics Corp, without any strings attached, even putting their name on the poscards.

Our presentation to the National Institutes of Health in 2002 was called “Connecting the Dots.” So, let’s connect them, shall we?

I am surprised that Dr. Shehab (see below) is so surprised at the results of his study. I am also curious to know who funded this study and why it was done. Are we finally making a case for prevention?

 A. Lok, et al. found primary care poviders did not identify risk factors or order tests quite a number of years ago. HCOP has  been talking about that study in presentations for a number of years as evidence of the need to educate doctors as well as the public. In that study, the researchers concluded that patients were not getting tested because they were not reporting risk factors. Huh? If we don’t know what the risk factors are, how are we going to present them? And, if the doctor doesn’t know there are risk factors beyond IV drug use, is the test going to be ordered?

We stand on our position for routine testing as presented to the NIH in 2002 Consensus Management Conference. It did not make it into the the recommendations, however. So, while all the experts hmmm and haww, how about WE start making some major decisions as parents, healthcare consumers and citizens? Do we really need to invest in more studies before we start to protect ourselves and our children? To learn how this affects other health issues, check out the blog below on “Who is really at risk?” and see how this issue crosses into public health on every level, at every age group and on every issue-childhood obesity, organ and tissue transplant and safe blood supply, to name only a few.

Further study? How about just rolling up our sleeves and DOING something? I want to know how much evidence is needed to get serious about this. As you read in prior blog entries, this goes back a long way. The Surgeons General (Koop, Satcher), the CDC (and P!?) the NIH, HCOP, and on and on…have known for years. It’s time we put it all together instead of one researcher at a time discovering this is a real and very serious problem. And, let me assure you this has no relationship to IV drug abusers. If you are one of the few people who still believes this: think again. It may have been true once (though I doubt it) We are well beyond that now.

The fact is, without funding, HCOP and other groups, though few, are always on the precipice of folding up shop. I’ll do what I can but, really, I am only one person. Step up and start getting involved. If you don’t, who will? I do not have the resources for professional fund raisers and grant writers. I have been advised that these will be provided, and have been provided, by some in industry (notably, Schering-Plough) I am not trying to create an industry, I am simply trying to inspire you and others to make this part of your social conscience and consciousness. My role, is to nudge people into action, to include this in every public health message, to make things better and to teach you how to do that.

I am speculating that hepatitis C has gotten lost in a sea of awareness of one thing or another. I am concerned about this. Not that it is more important than any other issue, but why are we putting all these concerns in separate efforts and not looking at the whole of things? Is it because much of this is marketing products and not responding to science? Has it gotten to the point that consumers have just turned it all off? If so, what needs to be done about it? My theory is, and has been for years, that we get out of the cycle of hepatitis C groups interacting with one another at conferences and spend time elsewhere, with other organizations (women’s health, childhood obesity, transplant, etc etc) I have stopped attending the big liver meetings. They are costly and an independent voice is unwelcome.  So, my priority has been to spent time where it is welcome, new, and changes what people think they know.  The hepatology/gastroenterolgy community is a closed one. Too bad when so much is at stake. But, then, it took me many years of beating my head against the wall there to learn this. So, who am I to judge?

From day one, we put out free brochures on our website and these have formed the basis of many efforts across the country and been incorporated into VA programs, local support programs, and probably efforts I know nothing about. Good. Take it and use it, please.

Here is the latest thanks to Jim, cfree, our online support moderator:

Newswise — College undergraduates in the United States do not recognize the magnitude of their risk behaviors for contracting Hepatitis C, according to a survey conducted at a large midwestern university. Researchers found that 75 percent of undergraduates in this study had a potential Hepatitis C risk factor, from tattoos to sharing body jewelry. Results of this study were presented at the 71st Annual Scientific Meeting of the American College of Gastroenterology in Las Vegas.

Researchers surveyed 610 college undergraduates on their knowledge of Hepatitis C and their personal experience with traditional (intravenous drug use, blood transfusions) and novel risk factors (sharing of body jewelry, tattoos). Twenty-seven percent didn’t know Hepatitis C Virus (HCV) could be spread through intravenous drug use, while 77 percent of students were unaware HCV could be transmitted by intranasal cocaine use. Furthermore, 53 percent of students reported sharing pierced jewelry.

“We were surprised by the proportion of undergraduates who were inadvertently putting themselves at risk for Hepatitis C,” says Thomas Shehab, M.D. of St. Joseph Mercy Health System and Huron Gastro. “In addition to well documented traditional risk factors, we are concerned about students who may be putting themselves at risk for this serious disease with even something as simple as sharing pierced body jewelry.“

One of the other concerning findings was the low frequency that the undergraduates were asked about viral hepatitis/HIV risk factors when seen by their primary care providers. “The majority of the group had been to the physician for a health care maintenance examination in the last three years, but during that visit most had never been asked about behaviors that put them at risk for serious infection,” says Dr. Shehab. Given the prevalence of these behaviors, researchers say further study should focus on this high-risk age group.

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Once more a person suggested that if only a celebrity came forward and spoke out about hepatitis c, we would advance the cause significantly.

 The “What if it were me?” thought prompts many celebrities to pump up the volume for research into diseases like AIDS, breast and prostate cancer as a prophylactic. However, one hidden killer lags far behind in funding and star power: HEPATITIS C.

So, it got me to thinking. Each of the celebrities listed here has had their condition(s) published. These conditions are public record. I guarantee you that there are many many more who are not willing to share. But, this is about those who have, so here it is.

Add to it if you wish, but do not add anyone who has not been public about it.  The list:

Anita Roddick, founder of the Body Shop,died from a hepatitis C-related brain haemorrhage in September 2007

Marianne Faithful,  Hepatitis C

Ken Watanabe, 46, leukemia  late 1980s,  hepatitis C

Willie Dixon            jazz musician, contracted hepC during heart tranplant

Cliff Arquette, (aka Charley Weaver)   liver transplant s/p hepatitis C

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Four Transplant Recipients Contract H.I.V

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From NY Times:

The Sting of Ignorance
By JERRY AVORN
Boston

LATE on a summer afternoon not long ago, the water at Lucy Vincent
Beach on Martha’s Vineyard was warm, and the toxic jellyfish that had
plagued bathers weeks earlier had floated out to sea. Body-surfing in on my last wave, I suddenly felt as if someone had whacked my leg with a lead pipe studded with nails. On the 1-to-10 pain scale we use with
patients, I would have called it a 14. When I rubbed the area with my
hand, my whole palm stung. Apparently those toxic jellyfish hadn’t all
left.

A crowd of passers-by gathered to offer tips from the tainted well of
conventional wisdom. “Use ammonia.” “Rub in some meat tenderizer.”
“Apply vinegar.”

Soon a small army of bronzed youths in official-looking tank tops
arrived carrying enormous medical kits. One poured sterile water on the sting area; another rubbed it with an ice pack. A third worked an
alcohol-based anesthetic into the wound. Each treatment made the pain worse.

Eventually our group attracted the attention of a nurse strolling down the beach. A year-round Vineyard resident, she had seen her share of vacation-related medical emergencies. “You’ve removed the tentacle,
haven’t you?” she asked matter-of-factly. No one, including the
medical-professor patient, had thought of this. She took a piece of gauze and pulled off a slimy, transparent string laced with
neurotoxins. It had continued to send those toxins into my leg for the first 20 minutes of my care. They are particularly activated, I would
later learn, by distilled water, by mechanical pressure (as from an ice pack), and by alcohol-based topical medicines - all the treatments I
had so earnestly been given.

Now the pain began to abate. I drove home and reached for three of the
most useful medicines I know: aspirin, acetaminophen (Tylenol) and the
Internet. As the first two began to take effect, the third revealed a
study published in February in The Medical Journal of Australia.

The clever Aussies (whose beaches are also infested by toxic jellyfish)
had conducted a clinical trial that randomly assigned sting victims to
application of hot water (to deactivate the poison) or icepacks. The
trial was stopped halfway through because the hot-water group did so
much better that it would have been unethical to continue. I didn’t
discover this through any proprietary medical search engines. I used
Google and Wikipedia, and it took about two minutes.

Coincidentally, much of my work is about defining which medications
work best for which conditions, and how to close the gap between that knowledge and the care patients typically receive. My research group
constantly comes across effective treatments that are underused, and
poor-choice drugs that are widely prescribed. Even when good clinical
trial data on a regimen or medicine exist, no coherent system ensures that the message gets out to doctors and patients. As a result, many
treatment choices are driven by habit, old information or glitzy promotional campaigns.

My aquatic encounter was a small example of what millions of patients confront daily, in much more serious circumstances. The nation faces two yawning medical information gaps. First, we need more studies
comparing treatments to each other, as that simple Australian trial did. Drug companies don’t usually do such tests, preferring to evaluate their new products by comparing them to placebos. (The drugs usually
win.)

The National Institutes of Health, facing its first real-dollar budget cut in generations, isn’t likely to expand its mandate in this direction. But what about the insurers, private and governmental, who pay such a large share of the nation’s $220 billion annual drug bill? They could support such studies with the rounding error of their annual
budgets - and then save billions if the findings were put into practice.

The second problem is that much of the knowledge we do have is not
communicated to the people who need it. Drug companies are adept at barraging doctors and patients with slick messages touting their most
expensive products - even if they are no better than older, more
affordable standbys. Maybe if Merck held the patent on hot water, my
well-intentioned beach squad would have known all about the Australian study. But that’s a poor way to ensure that patients receive the right care.

We need an unbiased, efficient system to get the word out to practitioners on what works best. My colleagues and I have done pro
bono research aimed at developing such an approach. Because the drug industry is so adept at changing beliefs and practices, we’ve taken a few leaves from its book.

In a program financed by the Commonwealth of Pennsylvania, called the
Independent Drug Information Service, we scan the medical literature for the best evidence on how to treat a given medical problem (like
high cholesterol or arthritis), boil it down into user-friendly packets of information, and then send nurses and pharmacists out to doctors’
offices to recommend optimal treatments. The information we provide is
unbiased and noncommercial, and we don’t offer free trips to golf
resorts. The resulting savings from more cost-effective prescribing
could more than cover the costs of programs like this.

The approach has been adopted in several Canadian provinces, and
Australia runs a continent-sized program to update its primary care
doctors (though I don’t know if it addresses jellyfish injuries). The
government covers expenses, but scientific content is determined by
nonprofit professional organizations. Their recommendations are transmitted in person by “outreach educators,” in concise newsletters, and electronically to doctors, health workers and patients.

If the Vineyard beach first responders had known of the latest research
results, they wouldn’t have done everything they could to transfer
toxin from the jellyfish tentacle to my leg. All of us need access to
current, noncommercial medical information. Besides helping to contain our runaway medication expenditures, programs of this kind could prevent a lot of needless suffering - by patients and doctors alike.

Jerry Avorn, a professor at Harvard Medical School, is the author of
“Powerful Medicines: The Benefits, Risks and Costs of Prescription
Drugs.”

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