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News Review

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HCV ADVOCATE WEEKLY NEWS REVIEW:
A Review of HCV, HBV and HIV/HCV Coinfection Related News and Highlights

Week Ending: February 23rd, 2008

Alan Franciscus
Editor-in-Chief

To download pdf version click here

This Issue:

 

February 17th, 2007


Riding the wine wagon
http://thestar.com.my
By Dr Albert Lim Kok Hooi

To your health, cheers, but too much drink and nobody knows your name.

I ENJOY a glass of wine with my food. When the match is right, for example, salmon and Pinot Noir, or a light-bodied Chablis and oysters, the meal becomes an exquisitely enjoyable experience. I enjoy wine with music and art. A glass of champagne does wonders to a romantic evening. Wine adds much to the pursuit of beauty and pleasure.

Over the past decade, more and more Malaysians are drinking wine, especially red wine. 

I initially thought that there was an Epicurean movement in the making. When I saw wine served in Chinese tea glasses at room temperature (over 30C recently) and in a raucous, noisome and odoriferous ambience, I thought again. 

Instead of sipping and savouring, there was gobbling and gulping. It was not for reason of aesthetics that most of them have taken to drinking wine. It was for reasons of health! 

And since the colour red is auspicious and Bin 888 is one of their favourites, courting Lady Luck is another incentive to drink wine!

If only the attainment of health and wealth were so easy and enjoyable!

I discuss the French Paradox, resveratrol – a molecule which resonates with promise – and wine and health, in particular cancer.

In the US in the early 90s, the TV series 60 Minutes aired a report on a phenomenon known as the French Paradox – the fact that the French have a lower rate of heart disease than Americans, despite a diet higher in fat. 

The one thing that the American diet lacks in comparison to the French diet is red wine. Some researchers looked for a link between the consumption of red wine and heart disease and found it! 

In the year following this report, Americans increased their purchase of red wine by 39%. I guess we are not alone in jumping onto the “wine wagon”; it is just that we are almost a decade behind.

Drinking small amounts of alcohol (not necessarily red wine) can reduce your risk of heart disease. Cancer Research UK is one authority that concurs. However, this applies only to men above 40 and women who have been through the menopause.

The maximum amount of alcohol you should be drinking is two units per day for women and three units per day for men. A standard 175ml glass of wine (of 11 to 12% volume) contains two units. A premium pint of beer (5%) contains three units. Beyond that, the harm (heart disease, cancer) outdoes the good.

There is actually some science behind the supposed benefits of red wine. Red wine is rich in resveratrol. It is a part of the plant’s defence system against disease. 

Resveratrol has been shown to reduce tumour incidence in animals. Scientists are studying resveratrol to learn more about its cancer preventive activities in man. This research is in its infancy. 

Even when resveratrol is proven to be anti-cancer, the amount you get in each glass of red wine is so minuscule, you will probably need 100 glasses of wine daily to tap its anticancer properties! In years to come, it may be possible to take a tablet of pure resveratrol. It is certainly more practicable.

Too much alcohol puts you at risk of cancer of the mouth, larynx (voice box), oesophagus (foodpipe), liver, breast and perhaps colon. Smoking and drinking together (de rigueur for a night out with the boys) increases your risk even more.

How does alcohol cause cancer? We are not entirely sure but there are several ideas. 

Alcohol is converted in the body into a chemical called acetaldehyde. This causes cancer by damaging our DNA and preventing it from being repaired. Alcohol can also increase the level of oestrogen in the body and this may be how alcohol causes breast cancer. Alcohol can cause cirrhosis of the liver and this in turn causes liver cancer. 

Finally, alcohol reduces the amount of folate in our blood. Folate is a B vitamin that our cells use to create new DNA correctly. Lack of folate can lead to mistakes in DNA and this may lead to cancer.

Alcoholism is not quite the problem it is in Malaysia the way that smoking is. Nevertheless, with our new affluence and the way we tend to binge, we may soon be on par with the first world. 

The incidence of mouth cancer is high in Malaysia. There is a high incidence of concurrent smoking and drinking alcohol among the victims. Liver cancer is very common in persons infected with hepatitis B or C virus. With alcoholism, the risks will be greater. 

In the UK, a study estimated that alcohol causes 2,000 breast cancer cases a year (out of a total of 44,000 cases). Alcoholism is not a big problem among women in Malaysia at present. However, one can never know what the future holds with the lifestyle trends we are witnessing today.

Drink by all means and be merry. But drink wisely and be the aesthete, not the alcoholic. 

Dr Albert Lim Kok Hooi is a consultant oncologist. For further information, e-mail starhealth@thestar.com.my.

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February 18th, 2007


Multidose vials rapped
http://www.nydailynews.com/
by Bill Egbert
Daily News staff writer

City and state officials want a national ban against the use of multidose vials, which are blamed for 75 hepatitis infections in New York City alone.

The infections, recorded by the state and city Health departments in 2001, 2002 and 2006, were transmitted during a variety of medical procedures all involving multidose vials.

Different needles are used for each injection, but when giving more than one medication to a single patient, sometimes health workers reuse the syringe, which can transmit traces of blood to one of the multidose vials.

Any patient then injected from that vial - even with a fresh needle and syringe - will be exposed to the infection.

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February 19th, 2007


Amarillo Bioscience Partner, CytoPharm, to Conduct 144 Patient Phase 2 Hepatitis C Trial in Taiwan
http://money.cnn.com

Amarillo Biosciences, Inc.(OTCBB: AMAR) today announced that the U.S. Food and Drug Administration has allowed the Investigational New Drug (IND) application submitted by the Company to test its low dose oral interferon in a Phase 2 hepatitis C clinical trial to go into effect. Accordingly, CytoPharm Inc., the Company's partner in Taiwan, will fund and conduct a clinical trial of 144 chronic hepatitis C patients in Taiwan. The patients will receive one of two different dosages of oral human interferon alpha or placebo.

The aim of the trial is to reduce relapse rate for those patients who have completed the standard combination therapy, consisting of high dose injectable interferon alpha and Ribavirin given orally. Although most patients respond to the standard therapy, up to 40% of those with certain viral genotypes relapse after treatment. The trial is expected to start in the 2nd quarter of 2008.

Approximately 170 million people are chronically infected with hepatitis C virus worldwide. The incidence of cirrhosis in chronic hepatitis C patients is 10% to 20% and 1% to 5% develop liver cancer. Infections are transmitted primarily by direct contact with blood through transfusions not screened for hepatitis C virus, inadequately sterilized needles and syringes, sexual and perinatal transmission. There is no effective vaccine against hepatitis C virus.

In addition to studies on hepatitis C, under the terms of the License and Supply Agreement, CytoPharm will be testing oral interferon in human studies of chronic active hepatitis B and influenza.

About Amarillo Biosciences, Inc.
Amarillo Biosciences, Inc. is a U.S. biotechnology firm operating in global partnership with the Hayashibara Group, which also holds 11% of Amarillo Biosciences shares and has provided over $18 million in loans, grants and equity investments. The Company's primary focus is extensive and ongoing R&D into the use of low-dose, orally administered interferon as a treatment for a variety of conditions, including Sjogren's syndrome, Behcet's disease, and opportunistic infections in patients who are HIV positive. In its 23-year history, the Company has invested nearly $39 million to establish oral interferon as a therapeutic agent. The majority of those funds were invested in clinical trials in an effort to achieve FDA approval for interferon. Additional information is available on the web site at http://www.amarbio.com/.

About CytoPharm
CytoPharm is a closely held company focusing on the development of biopharmaceuticals for virus-infected diseases and cancers. It was founded in 2002 by Ho Tung Chemical, Vita Genomics, and banks and venture capital firms. It acquired core technologies from Gene Trol Therapeutics, Inc., a California based company through M&A. Its product pipelines contain a series of cytokines induced by its proprietary technologies, used for hepatitis, and cancers. Currently, its product is under clinical trials in China. Both CytoPharm and Vita Genomics are affiliates of Ho Tung Chemical Inc., one of the largest petrochemical companies in Taiwan, and a publicly traded company whose 2006 revenues were approximately NTD 39 billion.

Except for the historical information contained herein, the matters discussed in this news release are forward-looking statements that involve risks and uncertainties, including uncertainties related to product development, uncertainties related to the need for regulatory and other government approvals, dependence on proprietary technology, uncertainty of market acceptance of oral interferon or the Company's other product candidates and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission. In particular, see "Item 1. Description of Business" of the Company's Form 10-KSB for the year ended December 31, 2006.

Investor Relations:
Philippe Niemetz
PAN Consultants, Ltd.
e-mail: p.niemetz@panconsultants.com
Tel: 800-477-7570
212-344-6464
Fax: 212-618-1276
Joseph M. Cummins, DVM, PhD
Amarillo Biosciences, Inc.
e-mail: jcummins@amarbio.com
Tel: 806-376-1741 x 13
Fax: 806-376-9301

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Mum leads fight against hepatitis C
http://www.manchestereveningnews.co.uk/
Paul Britton

A MOTHER-OF-FOUR has become the face of a new national campaign to raise awareness of the potentially fatal liver virus hepatitis C.

Susan Wright, 50, from Deane, Bolton, lived with hepatitis C for almost 30 years.

She was diagnosed with it in 2003 after a routine test when applying for health insurance.

Now, after being given the all clear last week, she is fronting the Department of Health's FaCe It campaign to improve prevention, diagnosis and treatment of the virus.

And Susan, who went through almost a year of treatment, is urging people to educate themselves and have tests.

She said: "Hepatitis C affects people from all walks of life.

"I lived with the virus for years without realising it, so I'm passionate about helping raise awareness so others are diagnosed and treated.

"The virus robbed years of my life but the earlier you get treatment for it the better your chance of beating it."

It is estimated 200,000 people in England carry the virus, with the majority unaware.

It attacks the liver and is spread through blood contact, transfusions, needles or tattoos.

About one-in-four people will get rid of the disease naturally. Chronic infection, however, can lead to cirrhosis, liver failure or cancer. Most people experience no symptoms. Others become jaundiced or just feel unwell.

The disease was identified in 1989 and testing began in 1991.

Susan had injected drugs as a university student in the 1970s.

She said: "I felt I had had hepatitis C since then but no one knew about the disease.

"I must have had it for about 29 years.

"I started to feel very unwell in the last few years before I was diagnosed, and it did not surprise me when I was told I had the virus. I lost a lot of weight and really felt poorly.

"I know it was my fault that I contacted the virus, but the treatment does work."

Dr George Lipscomb, gastroenterologist at the Royal Bolton Hospital, said between 50 to 80 per cent of sufferers can be cured with 12-month drug treatment programmes.

He said: "Nowadays there is a very good chance of cure. It does seem scary but we can now successfully treat people."

For more information on hepatitis C call 0800 451451 or visit www.hepc.nhs.uk

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End Postcode Lottery For Liver Disease Patients
http://www.thisisexeter.co.uk

Campaigners are calling for an end to a "postcode lottery" for hepatitis C treatment at a time when Devon is providing a good level of care.

In a survey looking at different aspects of the service, Devon Primary Care Trust scored eight out of 10 - meaning hepatitis C care in Devon is better than in Somerset, Gloucestershire and Dorset.

Hepatitis C is a virus that can seriously damage the liver and affect its ability to function. It is mainly spread through contact with the blood of a person who is infected.

More than 250 patients with hepatitis C are being seen regularly at the Royal Devon & Exeter Hospital at a specialist liver clinic each week.

And the campaign to ensure that high quality specialist treatment for the disease, like that provided in Exeter and Devon, is available throughout the country is being led by Gordon Roddick, whose late wife Dame Anita Roddick, who founded the Body Shop, revealed she had the disease a year ago.

Mr Roddick said: "For the first year after Anita's diagnosis we really didn't think hep C was serious at all. We just didn't know.

"Anita wanted us to be the best in the world when it came to tackling hep C."

Hep C is dubbed the silent killer, as people can live with it undiagnosed and without symptoms for many years.

Dr Mark Kealy, from the Health Protection Agency, said people who came forward wanting to be screened for hep C would be. But he said: "It's not just a matter of screening people and knowing they're positive, we have to be able to get them into treatment and be confident they'll continue, as it's expensive." He estimated costs of around £3,000 for a six-month course of treatment for one person and added that a lot of drug and alcohol users tended to not turn up regularly. Treatment can cause flu-like symptoms and patients had to be prepared to put up with side effects. He added that if untreated, hep C could lead to cirrhosis and liver cancer, and sufferers would often need a transplant to survive. Hep C can be caused through sex and can be passed from mother to child, but is most commonly caught by drug users injecting intravenously.

A spokeswoman for the RD &E said: "The Royal Devon & Exeter hospital runs a specialist liver clinic with about 250 regular hepatitis C patients coming in for treatment, counselling and advice.

"The patients are aged between 18 and 80 years old and their treatment is very much tailored to their individual health needs because patients can experience different symptoms and health issues. The RD &E is part of a peninsula-wide Hepatology Network which shares good practice."

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Perlegen and SC Liver Research Consortium to Collaborate on Interferon Response in Hepatitis C Patients
http://www.centredaily.com

MOUNTAIN VIEW, Calif. & SAN DIEGO — Perlegen Sciences, Inc., and the SC Liver Research Consortium (SCLRC), announced today a collaboration to discover genetic variations that predict which patients with hepatitis C (HCV) are most likely to benefit from treatment. The parties will conduct large scale genetic studies on samples from hundreds of patients with HCV who have been treated, successfully and unsuccessfully, with interferon alfa and ribavirin, the current standard of care for this disease.

The cure rate for HCV patients treated with interferon alfa and ribavirin is roughly 50%. Unfortunately, irrespective of efficacy, the treatment results in serious side effects including flu-like symptoms, fatigue, depression, fever and anemia. These symptoms dissuade a large number of patients from undergoing therapy, thus risking far more serious outcomes including progressive liver cirrhosis and hepatocellular carcinoma. The hope of the program is that those patients with genetic signatures indicating a likelihood of positive response will be more likely to undergo treatment, despite the associated side effects.

Perlegen's CEO, Dr. Bryan Walser, noted, "We are pleased to be working with SCLRC in this important pharmacogenomic study, which combines SCLRC's extensive expertise in clinical hepatology with Perlegen's expertise in identifying genetic variations. We hope the findings from this study will significantly improve outcomes for a great many patients with HCV."

Dr. Paul J. Pockros, President of the SCLRC, added, "This is an exciting opportunity to combine the expertise of our consortium's fifty research sites with Perlegen's skills in genetic analysis. The ability to help predict response to therapy could be a vital tool in our effort to cure hepatitis C in millions of patients infected with this virus."

About Perlegen Sciences
Perlegen's mission is to discover and commercialize genetic variations that can make a difference to patients and physicians. The company's expertise is in understanding human genetic variation within and across diverse patient populations and in conducting studies aimed at identifying those variations that are predictive of drug response, both toxicity and efficacy. For more information about the company and its technologies, visit Perlegen's website at www.perlegen.com.

About SC Liver Research Consortium
SC Liver Research Consortium (SCLRC) is an organization of physicians specializing in clinical hepatology and gastroenterology research. The consortium's mission is to team research sponsors and SCLRC's 50 research sites to provide faster, higher-quality research results than the current "conventional" sponsor-site arrangement. This is accomplished by providing streamlined contract and budget negotiations, access to scientific expertise in study design, site selection, and ongoing site evaluation. The SCLRC was formed in 1997 by a group of experienced liver/GI Hepatologists who wanted to advance the current state of liver disease research. Now a 93 member investigator team which includes Infectious Disease specialists who specialize in HIV co-infection, SCLRC has virtually eliminated the hepatitis learning curve by stepping up and authoring liver disease protocols for sponsors.

Perlegen Sciences, Inc. Robert Middlebrook, 650-625-4500 Chief Corporate Development Officer or SCLRC (www.scliver.com) Len LaFebre, 858-587-4440 Contracting Officer

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Research conducted at Duke University, Division of Infectious Diseases has updated our knowledge about hepatitis C virus cell biology
http://www.newsrx.com/

2008 FEB 18 -- Researchers detail in 'Specific polymorphisms in hepatitis C virus genotype 3 core protein associated with intracellular lipid accumulation,' new data in hepatitis C virus. "Steatosis is a common histological finding and a poor prognostic indicator in patients with hepatitis C virus (HCV) infection. In HCV genotype 3-infected patients, the etiology of steatosis appears to be closely correlated with unknown viral factors that increase intracellular lipid levels," scientists in the United States report.

"We hypothesize that specific sequence polymorphisms in HCV genotype 3 core protein may be associated with hepatic intracellular lipid accumulation. Using selected serum samples from 8 HCV genotype 3-infected patients with or without steatosis, we sequenced the HCV core gene to identify candidate polymorphisms associated with increased intracellular lipid levels. Two polymorphisms at positions 182 and 186 of the core protein correlated with the presence (p=.03) and absence (p=.005) of intrahepatic steatosis. Transfected liver cell lines expressing core protein with steatosis-associated polymorphisms had increased intracellular lipid levels compared with non-steatosis-associated core isolates, as measured by oil red O staining (p=.02). Site-specific mutagenesis performed at positions 182 and 186 in steatosis-associated core genes yielded proteins that had decreased intracellular lipid levels in transfected cells (p=.03)," wrote R. Jhaveri and colleagues, Duke University, Division of Infectious Diseases.

The researchers concluded: "We have identified polymorphisms in HCV core protein genotype 3 that produce increased intracellular lipid levels and thus may play a significant role in lipid metabolism or trafficking, contributing to steatosis."

Jhaveri and colleagues published their study in the Journal of Infectious Diseases (Specific polymorphisms in hepatitis C virus genotype 3 core protein associated with intracellular lipid accumulation. Journal of Infectious Diseases, 2008;197(2):283-91).

For more information, contact R. Jhaveri, Dept. of Pediatrics, Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina 27710 USA..

Publisher contact information for the Journal of Infectious Diseases is: University Chicago Press, 1427 E 60th St., Chicago, IL 60637-2954, USA.

This article was prepared by NewsRx editors from staff and other reports.

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February 20th, 2007


Pharsight to Host Webinar on Hepatitis C Virus (HCV) and HIV Drug-Disease Modeling
http://www.prnewswire.com

Dr. Bill Poland Will Discuss Best Practices in HCV and HIV Drug-Disease Modeling and Simulation to Support Clinical Drug Development Decision Making

MOUNTAIN VIEW, Calif., Feb. 20 /PRNewswire-FirstCall/ -- Pharsight Corporation (Nasdaq: PHST), a leading provider of software, strategic consulting, and regulatory services for optimizing clinical drug development, today announced that Bill Poland, Ph.D., vice president and lead scientist, Strategic Consulting Services, will speak to members of the pharmaceutical and biotechnology industries via web conference on HCV/HIV drug-disease modeling on Thursday, February 28, 2008, at 1:00 p.m. Eastern Standard Time (10:00 a.m. PST).

Dr. Poland's presentation, entitled "Portable Concepts for HCV and HIV Drug-Disease Modeling and Simulation" will discuss the use and strategic value of quantitative modeling and simulation to design, predict and improve clinical trial outcomes for HCV and HIV drugs. Applied case examples will illustrate that despite important differences between HCV and HIV, such as the potential to cure HCV and faster HCV dynamics, HCV trial outcomes, like those for HIV, can be predicted and improved by model-informed design. More information about this event is available at http://www.pharsight.com/events/events_home.php .

"HCV and HIV present special therapeutic challenges to drug development teams, including the emergence of resistance, complex pharmacokinetics, and patient compliance," said Shawn O'Connor, president, CEO and chairman of Pharsight. "To support planning and quantitative decision-making for antiviral development, it is important to leverage synergies wherever possible in the complexities of viral dynamics modeling. HIV and HCV drug development programs can benefit from Pharsight's predictive modeling methods and extensive knowledge of the competitive treatment landscape. Model-based approaches can lead to enhanced clinical trial designs and in developing strategies to optimize tradeoffs such as that between patient compliance and dosing regimen, as well as inform better clinical program investment decisions."

About Pharsight Corporation
Pharsight Corporation develops and markets integrated products and services that enable pharmaceutical and biotechnology companies to achieve significant and enduring improvements in the development and use of therapeutic products. Pharsight's goal is to help customers reduce the time, cost and risk of drug development, as well as optimize the post-approval marketing and use of pharmaceutical products.

Pharsight's approach enhances the fundamental element of drug development success: strong decision-making. By adopting the Pharsight approach, customers acquire a new decision-making process with the potential to systematically improve every level and phase of their business and scientific processes. Pharsight Corporation is headquartered in Mountain View, California. Information about Pharsight is available at http://www.pharsight.com.

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February 21st, 2007


Mother, daughter head to Florida in search of liver transplant
http://www.wickedlocal.com
By Daniel DeMaina
ddemaina@cnc.com

Melrose - Ann Linehan is speaking on the phone from her new two-bedroom apartment in Jacksonville, Fla. when she abruptly stops in mid-sentence, asking, “Can you hold on?” and leaving the conversation without waiting for an answer.

She returns to the phone moments later, unnecessarily apologizing.

“My phone started to ring and it could have been the hospital. God, I never want to miss that call,” she says. “Every time the phone rings, I jump out of my skin.”

With each chirp of the telephone, Linehan hopes to receive the news that led her and her daughter, Laura, to move to Jacksonville from Melrose on Jan. 4 — that Laura has a liver donor.

It seems like an incredible burden to transplant a complete life, even temporarily, 1,000 miles away just to receive something as relatively common as an organ transplant. Even more incredible is that move is away from Boston — a city well renowned for its hospitals  — but Linehan stresses that her family is fortunate, even blessed.

“This is my miracle that I found Jacksonville,” she said. “We’re the lucky ones, that we were able to have the means to get down here and we found it.”

Laura, 20, received a liver transplant at the age of 2, over a year after doctors discovered she had tyrosinemia, a metabolic disorder where the body cannot effectively break down the amino acid tyrosine, inhibiting proper development and possibly leading to liver and kidney failure, nervous system problems and an increased risk of liver cancer.

After the transplant, life continued as normal for Laura — until a letter arrived from Children’s Hospital just as she finished the fifth grade.

Laura had been given blood from donors infected with hepatitis C. She would need to be tested.

“Sure enough, she had hepatitis C,” her mother said.

Laura twice underwent treatment consisting of a regimen of injections and oral medications, which her mother called “horrible” and likened to chemotherapy.

“It’s supposed to be 40 percent effective. It didn’t work either time,” Linehan said.

“Hepatitis C typically takes anywhere from 20 to 40 years to become active. It’s a very slow disease. But because she’s immune suppressed, it kicked in faster with her. It has destroyed her transplanted liver, making it necessary for her to have another transplant.”

So Laura began waiting again for a transplant, her name put on the liver transplant waiting list on Oct. 10, 2006.

Two months later, on Dec. 22, one of Laura’s best friends, who was extremely sick and also needed a second transplant for a different reason, was lying in the operating room after finally finding a donor.

She died on the operating table.

“After watching her friend die, her mother had always talked about giving Laura a piece of her liver and they couldn’t do it,” Linehan said. “She got so sick that she couldn’t make it through the surgery. I just knew that after that happened that we had to find another solution.”

Discovering Florida
Coincidentally, a friend of the family originally from Rhode Island was visiting his parents when he came across an article in the Providence Journal, written by Los Angeles Times reporter Alan Zarembo, titled “Life or death depends on where you live.”

The article detailed how the U.S. has 58 territories for organ transplants. Most organs donated in those territories are only used for patients waiting in those areas, even if patients with a more immediate, critical need are outside that territory.

The article also told the story of a New York man who had been waiting four years for liver and kidney transplants. He moved to Jacksonville and received both in two weeks.

Linehan brought the article up to Laura’s doctors at Children’s Hospital, who confirmed the inequity in the organ transplant system and said they would “highly” recommend moving elsewhere to get a transplant more rapidly.

“They also said if anybody on this team needed a transplant we would send them to Jacksonville,” Linehan said. “We did the research that was necessary, the referrals, and came down here last spring. The doctors here [at the Mayo Clinic] said yes, she was a candidate, but wasn’t quite sick enough. They wanted us to wait until she got a little bit sicker and then come back.”

Transplant candidates are beholden to their MELD score — the Model for End-Stage Liver Disease that measures how effectively the liver excretes bile; the liver’s ability to make blood clotting factors; and creatinine levels which measure kidney function, often associated with severe liver disease.

The MELD scores range from 6 to 40 and have four categories: a score up to 10, scores between 11 to 18, scores between 19 to 24 and a score above 25, those in most severe need.

Laura’s score is currently 19, Linehan said.

“She probably sleeps 20 hours a day. She is holding about 35 to 30 pounds of fluid. She has no life,” she said. “She’s just waiting for the phone to ring. She’s very uncomfortable, she’s in a lot of pain, she’s exhausted and she’s not living like any other 20-year-old that I know. But she never complains and she feels terrible that she has disrupted our family. We would just do anything for her.”

While Laura’s current condition has obviously worsened and her MELD score is up to 19, staying in Boston still meant a long wait for a transplant.

“In Jacksonville, because they have so many more organs, they can transplant typically between the score of 15 and say 19 to 20,” Linehan said. “In Boston, they’re transplanting in the low 30s, 30 to 35. The patients are so sick by the time they get a transplant they either they die waiting, they don’t make it through the surgery or there’s a much greater risk of a successful transplant recovery, especially the second time around.”

Massachusetts versus Florida
According to the Organ Procurement and Transplantation Network’s Web site, optn.org., currently 1,553 registrations are listed for liver transplants in Massachusetts, while in Florida 2,941 registrations are listed.

However, Massachusetts only has one organ procurement organization (OPO) to nine transplant centers, while Florida has four OPOs to 10 transplant centers. The OPOs become involved when a patient is identified as brain dead — organs need to come from people whose hearts are still beating — and are therefore potential donors. The organization then coordinates between the potential donor’s family, the transplant center and the waiting transplant candidate.

Linehan said she was “absolutely blown away” when she visited Jacksonville last spring and asked the doctors about exploring using a partial transplant from a living donor.

“They said, ‘We think that’s a great idea, a great surgery, but we don’t do them here because we don’t need to. We don’t have a shortage of organs,” she said. “I just couldn’t believe my ears. They have five times as many organs as Massachusetts General Hospital, and they have a much larger region.”

The multiple OPOs in Florida are one reason for the surplus, Linehan said, adding she believes they are more aggressive at identifying and getting organ donors in Florida.

“Mass. General did 42 transplants last year and the Mayo did 200, and the Mayo’s number is down a little bit because a new center opened,” she said. “They are transplanting when the patients are healthier.”

Linehan also said there is no motorcycle helmet law in Florida and, given their climate, there are frankly more accidents resulting in potential donors.

She said her problem with the organ donor-transplant network is that not everyone has the wherewithal to simply move across the country to get a transplant.

“The big issue for me is the system is broken. They need to fix this,” Linehan said.

“There’s no reason why they can’t transport the organs around the country. Families should not have to completely disrupt their lives and move to another part of the country to get another organ. It’s just not right. Aside from the fact there’s just not enough emphasis put on donor awareness.”

Keeping connected to Melrose
Donor awareness is one way Linehan’s friends back in Melrose are supporting the family. Those friends have formed a group called “Random Acts of Kindness for the Lovely Laura Linehan” and are running a organ donor awareness campaign, running up to National Organ Donor Awareness month in April.

“They really want to put Melrose on the map for donor awareness,” Linehan said.

The group is also asking people in Melrose to donate airline miles and whatever else they can to help the Linehan family. The airline miles in particular are helpful, as they allow Laura’s father, Jim, and sisters Cara and Drew to visit regularly.

“It’s really hard to accept the help, but we are so, so grateful,” Linehan said. “I have to tell you, between giving up my business and paying rent, signing a year’s lease, shipping my car down, hiring a moving company, the list goes on and on. We’re supporting two households.”

In addition, now that they are out-of-state, Laura’s supplemental health insurance no longer takes care of the co-pays for medication — she is currently taking 20 different medications — although the family’s Blue Cross Blue Shield insurance will still cover the transplant itself.

Of course, beyond the logistics of the situation, the heart of the situation is being separated from family and friends. Linehan said she feels like “I’m in the witness protection program” and called Jacksonville “the land of the planned community,” filled with the same chains, retail stores and restaurants over and over.

“It’s amazing, I’ve been trying so hard to meet some neighbors and nobody talks to each other!” she exclaimed. “I think my only friend is Art the mailman, because I see him every day to go down and get my Random Act of Kindness.”

Linehan said she receives something almost every day from her friends back home.

One recent “Random Act of Kindness” sent by Linehan’s friends was bringing their Sunday coffee to Linehan. The women videotaped their Sunday coffee get together and spoke to the camera as if it were Linehan in the room with them. The videotape arrived in Jacksonville shortly thereafter, along with pastries and other goodies enjoyed at the get together.

“Oh my gosh, I cried for two days. It was unbelievable,” Linehan said. “I always knew I had a lot of friends, but I never knew how much they loved us, how much they cared about us and what they would do to help us. The sense of community has been unbelievable.”

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Lack of inmate treatment costs state $8M in lawsuit
http://www.jg-tc.com
By HERB MEEKER, Staff Writer
hmeeker@jg-tc.com  

Four prisoners each receive $2M

MATTOON — A federal jury in Urbana this week awarded $8 million to four state prisoners who claimed they were not treated for hepatitis C under Department of Corrections policies, a Mattoon attorney said Thursday.

H. Kent Heller of Mattoon said he filed the case on behalf of Coles County resident Ed Roe and three other inmates housed at Logan Correctional Center in Lincoln in 2005 after confirming state policy prevented treatment of the disease for prisoners with less than 18 months remaining on their sentences. Treatment for hepatitis C can extend several months or two years.

“Under the Eighth Amendment we claimed this was a form of cruel and unusual punishment because the state was showing a deliberate indifference to medical care for the prisoners,” Heller said of the case decided during a two-day jury trial in the federal court building in Urbana this week.

Heller said the state’s policy could prove lethal because hundreds of Illinois prison inmates are infected with the disease that can lead to liver failure. But Heller showed only a small fraction of the infected prisoners were receiving treatment, based on evidence presented during the trial through of records from the state and an out-of-state medical firm working with Department of Corrections.

“The inmates are not able to sue the state for negligence so this increased our burden of proof. So we had to show deliberate indifference on the part of state,” Heller said.

According to a Web site sponsored by Cedars-Sinai Health System in New York City, hepatitis C is a leading cause of cirrhosis and liver cancer and the most common reason for liver transplants in the United States. Blood-to-blood contact can cause transmission of the disease from different sources including injected drug use, improper needlesticks, tattoos or body piercings with unclean needles and multiple-partner sexual activity.

“Three of the four inmates have reported swelling in their abdomens, back pain and flu-like symptoms. They believe they are suffering from inflammation of the liver,” Heller said.

The judgment of $8 million for punitive damages was evenly divided among the plaintiffs, and included $20,000 each for actual damages reflecting the state’s cost per inmate Hepatitis C treatment. The plaintiffs’ case claimed the state saved $38 million by not treating up to 1,900 inmates for the disease.

Heller, adding this was the largest monetary judgment he has won for any client, explained the case went before a federal court because it involved litigation on civil rights. U.S. District Judge Harold A. Baker presided over the trial.

The Chicago Daily Law Bulletin contributed to this story.
Contact Herb Meeker at hmeeker@jg-tc.com or 238-6869

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University of Sydney researchers find new evidence linking kava to liver damage
http://www.eurekalert.org

In recent years, serious concerns about the dangers of kava and the effects on the liver have resulted in regulatory agencies, such as the US Food and Drug Administration and Australia's Therapeutic Goods Administration, banning or restricting the sale of kava and kava products.

Originally from Fiji, where kava drinking is common, Professor Iqbal Ramzan, Dean of Pharmacy at the University of Sydney, Australia, had previously published articles on the adverse effects of kava, and wanted to investigate further the effects kava had on the liver.

His findings are published in the January 28, 2008 edition of the World Journal of Gastroenterology. Leading a team of researchers from the University of Sydney, Professor Ramzan spent one year investigating the cellular effects of kava on the liver. Kava has been used in ceremonies and for recreational and social purposes in the South Pacific since ancient times, much like alcohol, tea or coffee is in other societies today.

In the 1980s other medicinal uses for kava began to emerge and it was marketed in herbal form as a natural way to treat conditions such as anxiety, insomnia, tension and restlessness, particularly in Europe and North America.

More recently, evidence began to emerge about the adverse affect kava could have on the liver.

To test these theories, the University of Sydney study focused on the major kavalactone (the ingredient in kava believed to affect the liver) -- kavain -- and investigated the effects it had on the ultrastructure (or biological structure) of the liver.

This required the use of electron microscopes (which enable the examination of the interior of cells) provided by the Australian Key Centre for Microscopy and Microanalysis at the University of Sydney under the direction of its Deputy Director, Professor Filip Braet.

The study found that following kavain treatment the liver tissue displayed an overall change in structure, including the narrowing of blood vessels, the constriction of blood vessel passages and the retraction of the cellular lining.

Interestingly, kavain also adversely affected certain cells which function in the destruction of foreign antigens (such as bacteria and viruses), which make up part of the body's immune system.

In other words, the kavain treatment disturbed the basic structure of the liver, consequently seriously impacting the normal functioning of the liver.

The results of the University of Sydney's study clearly support earlier literature observations on kava's adverse affects on the functioning of the liver in general.

However, additional investigations into the effects of other major kavalactones on the liver, as well as studies on whether the effects of kava are reversible, are urgently needed.

###
Reference: Fu S, Korkmaz E, Braet F, Ngo Q, Ramzan I. Influence of kavain on hepatic ultrastructure. World J Gastroenterol 2008 January 28; 14(4): 541-546
http://www.wjgnet.com/1007-9327/14/541.aps

Correspondence to: Professor Iqbal Ramzan, Faculty of Pharmacy, The University of Sydney, NSW 2006, Australia.
dean@pharm.usyd.edu.au
Telephone: +61-2-93512077 Fax: +61-2-93516950

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