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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: April 9th, 2005

Alan Franciscus
Editor-in-Chief

To download pdf version click here


This Issue:


New Effort Aimed at Tainted-Blood Victims

Hepatitis C Is a Virus Which Can Cause Fatal Liver Problems

Money Left Over in Hepatitis C Account: Smitherman

Hepatitis B: There Is a Safe and Effective Vaccine for Hepatitis B

Bayer Healthcare Receives US FDA Approval for Hepatitis Total Assay

Stealth Disease

Budesonide with Ursodeoxycholic Acid Improves Cirrhosis Liver Histology

Hep-C Compensation Fund Proves Tough to Expand

Med Center Wants to Test 900 More for Hepatitis C

Bill Mandates Free Vaccines for Hepatitis-B

Hepatitis Woman Threw Blood in Doctor's Face

Understanding Natural Killers Could Lead to New Hepatitis Treatments

Prognosis of Hepatocellular Carcinoma Established by Comparing Systems

Hep C Compensation Vote on Hold

Tampa Bay Hepatitis & Liver Disease Support Group Opens Chance Center

Hep C Vote: Liberals Can Right a Wrong

Assessment of Sexual Functions in Patients with Chronic Liver Disease

Transition Therapeutics Receives Approval to Initiate Hepatitis C Phase I/II Clinical Trial

Ban Stymies Blood Probe Clark Backs Papers Secrecy


April 4th, 2005

New Effort Aimed at Tainted-Blood Victims
Source: The Globe and Mail
By ANDRÉ PICARD

The seemingly endless saga that is the tainted-blood scandal will take a big step toward resolution this week as Parliament prepares to extend compensation to the so-called forgotten victims.

A motion being tabled today in the House of Commons by Conservative health critic Steven Fletcher calls for compensation to be extended to everyone who contracted hepatitis C from tainted blood.

Previous legislation led to compensation of victims who contracted HIV-AIDS from contaminated blood and those who were infected with hepatitis C between 1986 and 1990.

But those who were infected prior to 1986, when a screening test became available but was not used, and those infected after 1990 when the test was used to screen blood, have always been denied help, a reality that has been the source of much bitterness.

"Despite tremendous odds, the forgotten victims have fought back and we've just about won," said Michael McCarthy, a hemophiliac who contracted hepatitis C from blood products.

The motion, which will go to a voteon Wednesday, is certain to pass because it has the unanimous support of opposition parties. The motion to extend compensation to all those infected with hepatitis C has twice been introduced before, but died after procedural moves by the Liberals.

This time around, the procedural rules have changed, making a vote mandatory, and the Liberals do not want their minority government to fall on this issue.

"The Liberals have had no qualms about manipulating the system for their own political ends," Mr. Fletcher said.

"They can't get away with such flagrant abuse any longer. Victims of hep C will finally be heard."

Mr. McCarthy said that with victory in sight, the feeling is bittersweet.

"It's kind of sad that it took so long for justice to be done, but we'll take it."

However, there is still one big hurdle to get over before the victims see any compensation money.

The $1.1-billion set aside by government for victims of hepatitis C tainted blood is sitting in a trust fund overseen by the courts and a group of lawyers who settled class-action lawsuits related to infections that occurred in the 1986-90 period.

Those lawyers have vigorously opposed extending compensation to others.

Federal Health Minister Ujjal Dosanjh has said the "right and responsible thing to do" is to compensate all tainted-blood victims equally, but he acknowledged that there are legal issues to be resolved.

Government lawyers have been negotiating with the class-action lawyers, without any resolution. Ottawa will likely commission an actuarial study to determine whether there is enough money to go around.

Frustrated victims have said the whole matter could be resolved easily if Ottawa gave a guarantee that it would cover any shortfall to the trust fund.

There are fewer than 5,000 victims from the 1986-90 period who have made claims. There are approximately the same number of forgotten victims.

Successful claimants do not receive a fixed amount; rather, there is a complex formula that can see them receive annual payments of up to $30,000 plus money for drug therapy not covered by provincial health plans, uninsured medical expenses, loss of income, funeral expenses and loss of services (a catchall category that can cover such things as a child's tuition or paying to have the driveway shovelled because the claimant is too sick to do so.)

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Hepatitis C Is a Virus Which Can Cause Fatal Liver Problems.
SourceURL:http://news.bbc.co.uk

Although some modern treatments can control it in some patients, on the whole it remains an infection which is very hard to treat.

The virus is carried in the blood, and people with the infection can pass it on if their blood gets under the skin or into the bloodstream of another person.

Examples of how this might happen include intravenous drug users sharing syringes, or a surgeon with the infection who is cut while carrying out an operation, with the blood getting into the patient's wound.

It can also be passed on through sexual contact, as the virus can be present in bodily fluids such as semen.

The word hepatitis in general refers to an inflammation of the liver - which can be caused either by the C virus, or by other viruses, drinking too much or even by a condition in which the body's own immune system attacks liver cells.

Symptomless
Some patients - some 20% - manage to get rid of the hepatitis C virus within six months without ever suffering the symptoms of the disease.

In the remainder, the virus can remain in the body, again perhaps not causing any symptoms, for even a period of decades.

However, if the liver inflammation begins to get worse, then symptoms can appear.

These include jaundice, a condition which tells doctors that the liver may not be working properly.

In this the skin turns yellowish, as do the whites of the eyes. It is associated with fatigue.

Other symptoms of hepatitis C include weight loss, alcohol intolerance, vomiting and flu like symptoms.

If severe liver inflammation persists, serious damage may occur.

Tests for hepatitis C
Blood tests may be able to tell doctors if hepatitis C is present. However, as the test is looking for signs that the body's immune system is trying to fight the virus, it may not be positive for a few months after infection.

A doctor may also want to carry out "liver function tests" to see how well the liver is working, or even take a sample of liver tissue - a liver "biopsy" to check for serious damage.

Treatments
Currently, hepatitis C is treated with a combination of two drugs, interferon alpha and ribavirin.

About 40% of patients respond to this "combination" therapy.

In some cases, however, doctors who know a patient has hepatitis C may opt to simply keep an eye on them to check that liver damage is not occurring.

If liver damage is severe, then a transplant may be the only option. The shortage of organs for transplantation is a severe problem - patients may have to wait some time before one becomes available.

Even when the liver is replaced, this does not cure the virus - the virus infects the new liver and will eventually start to damage it in the same way.

The operation simply buys some time and improves the general health of the patient.

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Money Left Over in Hepatitis C Account: Smitherman
SourceURL:http://toronto.cbc.ca
CBC News

TORONTO --Ontario's health minister says he will make a new effort to track down hepatitis C sufferers who have not applied to a provincial compensation fund.

The $200-million fund was set up to supplement a federal plan, which only paid those who acquired hepatitis C from tainted blood between 1986 and 1990.

But George Smitherman says the number of people eligible for the provincial grants of up to $25,000 has turned out to be far fewer than expected.

"That fund was established on some actuarial suggestion of the number of people who might have been affected," Smitherman said.

"We have not so far identified that number of people."

As a result, the fund still has $113 million left in it.

Smitherman says he's going to launch a new public awareness campaign to try to find people who still might not know they're eligible for compensation.

However, the head of the government's new hepatitis C task force suggests there might not be a lot of victims still out there.

John Plater says the government could use the remaining money to increase compensation for the people who have already applied.

"Twenty-five thousand dollars in Ontario, compared to what many people experience living with hep C, is not necessarily a lot of money," Plater said.

A spokesperson for Smitherman says increased compensation may be one of the issues for Plater's task force to look at.

The task force was announced six months ago with Plater's appointment.

Its other members were finally appointed last week, after Plater complained that meetings had yet to be scheduled.

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Hepatitis B: There Is a Safe and Effective Vaccine for Hepatitis B
SourceURL:http://news.bbc.co.uk

Hepatitis B is the most common serious liver infection in the world. It is thought to be the leading cause of liver cancer. The World Health Organization estimates that hepatitis B infections lead to more than one million deaths every year.

What causes hepatitis B?
The disease is caused by the hepatitis B virus (HBV) that attacks the liver.

The virus is transmitted through blood and bodily fluids that contain blood.

This can occur through direct blood-to-blood contact, unprotected sex, and illicit drug use.

It can also be passed from an infected woman to her new-born during the delivery process.

Does the virus always pose a health threat?
It is thought that about one in three of the world's population is infected by HBV.

However, about 50% of those who carry the virus never develop any symptoms.

About nine out of ten people infected with HBV will eventually clear the virus from their bodies. But about 5-10% of infected adults will become chronic hepatitis B carriers, often without even knowing it.

What are the symptoms?
The virus can cause a range of problems, including fever, fatigue, muscle or joint pain, loss of appetite, nausea and vomiting.

Chronic carriers have an increased risk of developing liver disease such as cirrhosis or liver cancer, because the hepatitis B virus steadily attacks the liver.

Chronic carriers will usually have on going inflammation of the liver and may eventually develop cirrhosis and liver cancer.

About 1% of people who are infected develop an extreme form of disease called acute fulminant hepatitis.

This condition can be fatal if not treated quickly. Sufferers may collapse with fatigue, have yellowing of the skin and eyes (jaundice) and develop swelling in their abdomen.

How is it treated?
There are several drug treatments available to treat hepatitis B.

Patients may be put on a four month course of injections of the drug interferon.

An alternative treatment is a drug called lamivudine which is taken orally once a day. Treatment is usually for one year. Sometimes lamivudine is combined with interferon.

Chronic patients may require a liver transplant.

Can it be prevented?
Yes, by the use of a safe and effective vaccine.

However, for the 400 million people world-wide who are already carriers of HBV, the vaccine is of no use.

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Bayer Healthcare Receives US FDA Approval for Hepatitis Total Assay
SourceURL:http://www.pharmabiz.com
Leverkusen, Germany

Bayer HealthCare, Diagnostics Division, a member of the Bayer Group has announced the sixth FDA approval for automated assay for hepatitis on its ADVIA Centaur Immunoassay System.

The US Food and Drug Administration approved Bayer HealthCare Diagnostics' assay for Hepatitis A (HAV) Total, an in vitro diagnostic immunoassay for the qualitative determination of total antibodies to the hepatitis A virus in human serum or plasma. The assay can be used by laboratories to aid in the diagnosis of previous or ongoing hepatitis A viral infection or in the identification of HAV-susceptible individuals for vaccination.

The company release says, with this most recent approval, Bayer HealthCare Diagnostics offers one of the most comprehensive test panels for hepatitis testing in United States including two assays for the hepatitis A virus (HAV IgM and Total), three assays for the hepatitis B virus (HBc IgM, anti-HBs and HBc Total), as well as an assay for the detection of the hepatitis C virus (anti-HCV).

Bayer HealthCare Diagnostics offers the HAV Total assay on the ADVIA Centaur immunoassay system, making the hepatitis panel ideal for medium and large volume laboratories. The addition of this assay to the platform allows laboratorians to enhance their level of automation in performing these assays with such features as: software that provides automatic algorithm processing, cascade reflex testing, user-defined panels, automatic repeats of critical samples, and sample and reagent integrity checks, the release claims.

"The approval of the assay for HAV Total brings Bayer HealthCare Diagnostics one step closer to offering the industry's most extensive panel for hepatitis testing. At the same time, this meets our customers' demands for practical assays that enhance the efficiency and value of their laboratories," commented John Nosenzo, Senior VP and general manager of the North America Region for Bayer HealthCare's Diagnostics Division.

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Stealth Disease
SourceURL:http://www.floridatoday.com
BY KING QUILLEN
FLORIDA TODAY

Hepatitis C can lay latent for years before diagnosis

Possible culprit. When Jeff Laraway was 20, he got a snake tattooed on his right arm. Twenty years later, the Melbourne man was diagnosed with hepatitis C, a deadly blood-borne virus. He believes the virus came from the needle used to decorate his arm.

When he was 20, Jeff Laraway wanted a menacing snake tattooed onto his arm. He had no idea a deadly blood-borne virus could flow into his body from the unsterilized needle that had pricked many other people's skin.

Twenty years later, following a routine physical exam and blood tests, Laraway was diagnosed with hepatitis C.

Mary Kraft needed a blood transfusion during emergency surgery in 1988. She, too, had no idea the blood she received that day might carry a dangerous virus. But when she tried to donate blood 11 years later, Kraft was rejected because routine screening tests, perfected in 1992, detected hepatitis C in her blood.

Hepatitis C is a liver inflammation that can lead to cirrhosis and cancer. It is the No. 1 cause for chronic liver disease and for liver transplantation in the United States, according to the American Liver Foundation and federal estimates.

With early detection, experts say, people with the virus can be monitored, taught to limit other liver irritants and treated, when appropriate.

Long delays between infection and diagnosis, however, are not unusual.

"It's a stealth disease. Most people don't know they have a problem until a routine blood test turns up something," said Barry Inman, an epidemiologist with the Brevard County Department of Health.

Although new infections nationally have declined -- from an average of 240,000 cases in the 1980s to about 30,000 in 2003, according to the Centers for Disease Control and Prevention in Atlanta, the number of those who are chronically infected and newly identified has shot up.

An average of 10 new hepatitis C case reports land on Inman's desk daily. He estimates between 10,000 and 15,000 Brevard residents have the virus, first identified about a decade ago, as do more than 300,000 Floridians and 3 million to 4 million Americans. Most have not been diagnosed.

"The trouble with hepatitis C is once you get it, the disease 99 percent of the time does not manifest itself. The diagnosis is made incidentally 20 to 30 years later," said Dr. Salman Rashid, a Cocoa Beach gastroenterologist.

"What's really important is getting information out about risk factors and getting people tested," said Andi Thomas, executive director of Hep-C ALERT, a national advocacy and support organization in Miami.

"The window of opportunity to identify those most at risk for progressive liver disease is closing," she said, referring to the virus' long latency period. Late diagnosis often renders existing treatments ineffective.

The virus spreads through infected blood and blood products. Blood transfusions received before 1992, a single illegal drug injection or long-term kidney dialysis could put a person at risk of infection.

Tattoos with unsterilized needles, intravenous drug use with shared needles, and sex with multiple partners are leading causes, said Dr. Barry Mills, a gastroenterologist with Melbourne Internal Medicine Associates.

Some patients who become infected can clear the virus on their own, Mills said. The rest become chronically infected.

Hepatitis C can be managed successfully, but it can be deadly, especially if discovered after years of liver damage. That's what happened to Laraway.

When he was diagnosed, his gastroenterologist performed a liver biopsy to check the extent of damage. It proved considerable.

"He noticed a lot of cirrhosis and scar tissue in the liver," Laraway said. "It was pretty much half gone."

Laraway endured three courses of treatment during the next two years, which didn't work. The virus can be difficult to treat.

"Hepatitis C is a chameleon virus, it keeps changing shape. The immune system is always lagging behind," Rashid said.

About 25 percent of nonresponders experience severe complications, said Dr. Ghassan Hammoud, a liver specialist and a clinical assistant professor of medicine with the gastroenterology and hepatology division at the University of Florida, Jacksonville.

Laraway did. The Melbourne resident is being evaluated for a liver transplant.

The demand for liver transplants exceeds the organ availability. While more than 17,000 patients in the United States waited for liver transplants during 2004, only 6,167 received one, according to the United Network for Organ Sharing.

Veterans' risk
When infected individuals are identified in earlier stages of the disease, positive outcomes are considered more likely.

"Life is fantastic now," Bill Semeta of Indian Harbour Beach tells anyone who asks how he's doing. But that wasn't the case when blood bank officials initially told him his blood had tested positive for hepatitis C.

He never had heard of the virus, but saw it described as "deadly" in the next day's paper.

"I broke out in a cold sweat," he said.

Like Laraway, Semeta believes his infection began with a tattoo, which he received while on military duty overseas.

"People were lined up around the block getting tattoos," he recalled. "The guy probably wiped the needle off with a cloth between tattoos."

Veterans seem to be a high-risk group. A study published in the January Hepatology found veterans enrolled in Veterans Health Administration health care had a higher hepatitis C incidence than the general population.

Most at risk were veterans from the Vietnam era and those who used injection drugs, had tattoos or were jailed for more than 48 hours, the Veterans Administration researchers said.

For the past few years, all those receiving any care at veterans' facilities have been screened for hepatitis C. Some 250,000 veterans have tested positive.

When Semeta was diagnosed in 1998, recovery rates were less than 20 percent, but a newly approved combination therapy of interferon and ribavirin promised better results.

He took pills twice a day and injected himself three times a week for 48 weeks.

Six months after treatment ended, he achieved a "sustained viral response," with no virus found.

Semeta's virus turned out to be genotype 1, the most common of six genetic variations identified and the most common form of the virus seen in the United States, according to the University of Florida's Hammoud.

While positive response rates for treatment for genotype 1 range between 40 percent and 50 percent, he said, rates for genotypes 2 or 3 are better and can reach 70 percent.

'Devil's medicine'
JoAnne Walter thinks she contracted the virus during dental surgery while her family traveled in the Middle East on business in 1982.

A checkup when she returned to New York showed elevated liver counts, with the cause only attributed to "non-A, non-B hepatitis." By 1998, more was known about the virus, which had been labeled "C" to clearly distinguish it from hepatitis A and hepatitis B.

Walter, by then a Cocoa resident, entered a clinical trial at the University of Miami Liver Center, with no symptoms and feeling fine before her rigorous treatment began. During treatment, she had fatigue, nausea, hair loss and itching. A year later, she received a "100 percent clean" report.

"The devil's medicine" is what many of Hammoud's patients call treatments, which now include a time-released version of interferon, requiring fewer injections.

"Only about 15 out of 100 (patients) drop out because of side effects," Hammoud said. "After they are on medication four to eight weeks, the body tolerates it."

Although anyone at risk should be screened for hepatitis C, not everyone who tests positive is immediately treated. Some are monitored, cautioned about liver irritants, vaccinated against hepatitis A and B, and advised about precautions to avoid transmitting the virus.

When Kraft was diagnosed, for example, her liver enzymes were normal and she had minimal liver changes. Her periodic test results continue to be normal.

"It's there, but it's not causing problems," she said. "I consider myself very fortunate."

In 1999, Kraft became the facilitator for a local support group that meets monthly at Wuesthoff Medical Center-Rockledge.

Additional support comes from help lines provided by drug manufacturers, such as Schering Corporation's "Be in Charge" program. But, the best support eventually may come through better treatments.

In February, scientists at the National Institute of Diabetes and Digestive and Kidney Diseases reported in the Proceedings of the National Academy of Sciences that they had replicated the virus, which should improve research capabilities.

"I have a great deal of optimism," said Rajen Koshy, hepatitis program officer at the Division of Microbiology and Infectious Diseases at the federal research institute. "Breakthroughs are coming that portend a good future for this kind of research."

In the meantime, the work of identifying and educating those with chronic hepatitis C continues.

"Be an advocate for your own health," Kraft urged. "People could be walking around with it. The danger comes when it goes on for years and years. It's important for people to know if they are at risk."

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April 5th, 2005


Budesonide with Ursodeoxycholic Acid Improves Cirrhosis Liver Histology
SourceURL:http://www.gastrohep.com

Budesonide combined with ursodeoxycholic acid improves liver histology, whereas the effect of ursodeoxycholic acid alone is mainly on laboratory values, finds this month’s Hepatology.

Ursodeoxycholic acid is a safe medical therapy for primary biliary cirrhosis, but its effect on liver histology remains uncertain.

Budesonide is a glucocorticoid with high receptor activity and high first-pass metabolism in liver.

Dr Rautiainen and colleagues from Finland evaluated the combination of budesonide and ursodeoxycholic acid on liver histology compared with ursodeoxycholic acid alone.

The investigative team conducted a 3 year prospective, randomized, open multicenter study.

The team randomized patients with primary biliary cirrhosis (n = 77), at stages I to III into 2 treatment arms.

The first treatment arm (n = 41) received budesonide 6 mg/d and ursodeoxycholic acid 15 mg/kg/d and the second (n = 36) received ursodeoxycholic acid 15mg/kg/d.

The investigators assessed liver histology at the beginning and at the end of the study.

The researchers undertook liver function tests and determined glucose and cortisol values every 4 months.

Paired liver biopsy specimens were available from 69 patients.

The research team found that the stage improved 22% in the first group but deteriorated 20% in the second group.

A mild systemic glucocorticoid effect from budesonide was evident in the combination group – Hepatology

Fibrosis decreased 25% in group 1 but increased 70% in group 2 whilst serum III procollagen decreased significantly in group 1.

The team observed that inflammation decreased in both groups, 34% in group 1, but only 10% in group 2.

In addition, the research team noted that serum liver enzymes decreased significantly in both treatment arms.

Bilirubin values rose in the second group but stayed stable in the first group.

Finally, the researchers also reported that a mild systemic glucocorticoid effect from budesonide was evident after 2 years.

Dr Rautiainen's team concludes, "Budesonide combined with ursodeoxycholic acid improved liver histology, whereas the effect of ursodeoxycholic acid alone was mainly on laboratory values."

Hepatology 2005: 41(4): 747 – 752

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Hep-C Compensation Fund Proves Tough to Expand
SourceURL:http://www.canoe.ca
DENNIS BUECKERT, CP

OTTAWA -- Five months after the federal government said it was willing to compensate the "forgotten victims" of tainted blood, there are indications it may be harder than expected to change the terms of an existing compensation fund set up for victims who were infected from 1986 to 1990. Slow progress on the file was highlighted yesterday when Conservative MP Steven Fletcher introduced a motion demanding immediate compensation for all hepatitis C victims, regardless of when they were infected.

"Will the minister act immediately to help those who need this government's help or will the minister let more people die while he dithers?" Fletcher said in the Commons.

The controversy goes back to the 1990s when Ottawa and the provinces set up a $1.1-billion fund to compensate people infected with hepatitis C through tainted blood from 1986 to 1990.

People infected before 1986 were excluded on the grounds there was no test to screen for the virus before then.

But it has been learned since there were fairly effective tests available.

Meanwhile, fewer 1986-1990 victims than expected came forward to claim help from the fund, leading to calls for any surplus to be distributed to people infected outside the original window of eligibility.

Health Minister Ujjal Dosanjh promised in November to open negotiations to compensate all victims.

However, a lawyer involved in managing the fund says it's not clear there is a surplus.

Harvey Strosberg said it also could be argued any surplus should be used to enhance benefits for the originally designated beneficiaries.

He said a study is underway to determine whether there is a surplus, a difficult question since the money is supposed to last for 80 years.

The result of that study is expected in June but it could take longer, he said.

Junior Health Minister Robert Thibault said he agrees with the spirit of the opposition motion to compensate all victims but said its wording is flawed.

It's not clear what position the Liberals will take when the motion comes to a vote.

Hepatitis C activist Mike McCarthy said the government should compensate all victims no matter where the money comes from.

"We all know there are a number of lawyers involved in that fund that are not easily going to give up that money," he said.

"It's been a cottage industry for the legal community. Upwards of $80 million have gone to legal expenses."

David Harvey, a lawyer representing excluded victims, said everyone is working in good faith, but the issues are complex.

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Med Center Wants to Test 900 More for Hepatitis C
SourceURL:http://www.kvia.com

EL PASO, TX. - Officials at William Beaumont Army Medical Center want to test 900 more people for Hepatitis C. Last fall, 249 patients were thought to have been exposed to the virus by a member of the hospital staff during surgical procedures.

Of those exposed at the Northeast El Paso hospital, 16 patients eventually tested positive for Hepatitis C. Now the hospital wants to test 912 more patients. The new round of testing comes after one patient, who was not thought to have been at risk, tested positive for the virus.

The investigation continues into just how the hospital staffer spread the virus.

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Bill Mandates Free Vaccines for Hepatitis-B
SourceURL:http://news.inq7.net/
Inquirer News Service
Philippine Daily Inquirer

CALAMBA CITY-Despite government programs to control the spread of hepatitis-B virus, more than eight million Filipinos, or about 10 percent of the country's population, are inflicted with the dreaded disease, a Cavite lawmaker Tuesday said.

Given the threat of the spread of the hepatitis virus, Rep. Joseph Emilio Abaya (1st District, Liberal) has filed House Bill No. 3865, which seeks to mandate all medical institutions and health personnel, public or private, to give hepatitis-B immunization to all newborn infants.

Called the "Newborn Hepatitis-B Immunization Act of 2005," the bill also provides for free immunization for babies born in public health institutions. Immunization for babies delivered in private hospitals will be shouldered by parents or guardians.

Abaya said newborns are more prone to contact the disease than grown-ups.

He said there is a 90-percent chance for babies to be infected with the virus if their mothers are potential carriers.

Abaya said one-fourth of infants who were infected at birth die from cancer of the liver.

He said existing laws that mandate hepatitis immunization for babies are not enough to prevent the spread of the virus.

He said Republic Act 7846 only orders immunization for infants whose mothers were found to be carrying the hepatitis virus.

He said the country needs a law that would strictly instruct health personnel to administer hepatitis immunization to newborns whether their mothers are positive or not.

The bill said babies should be given immunization within 12 hours after delivery.

It said infants should be administered with the second dose one month after the first shot and be given with the third dose six months after birth.

The bill said the second and third shots should be given at the local health centers where the infant resides. Marlon Ramos, PDI Southern Luzon Bureau

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Hepatitis Woman Threw Blood in Doctor's Face
SourceURL:http://www.themercury

A WOMAN who was angry after being refused drugs flicked blood into a doctor's face and told him she had hepatitis.

Lisa Anne Dennison, 23, pleaded guilty in the Supreme Court in Hobart yesterday to aggravated assault.

The court heard that in October Dennison went to a North Hobart surgery suffering the effects of drug withdrawal.

Her lawyer, Philippa Grace, said Dennison had not filled her methadone prescription with her doctor at Kingston because her regular lift had not been available.

She said Dennison became angry after a female doctor at the North Hobart surgery was only prepared to give her three valium.

Dennison shouted and swore until a male doctor tried to get her to leave.

She kicked and broke a glass side panel of a door and ran away when the doctor tried to make a citizen's arrest.

The doctor chased her until she became exhausted and stopped at a coffee shop.

While the doctor stood with Dennison, she realised her hand was bleeding and flicked it at the doctor's face saying: "Take that you dog. I've got hep."

Prosecutor Jackie Hartnett said the doctor understood Dennison to mean she had hepatitis.

The court heard Dennison had hepatitis C.

The doctor had a three-month wait for the results of blood tests which showed he had not contracted the disease.

Ms Grace said Dennison felt "terrible" for her actions and asked that her apologies be passed on to the doctor.

Justice Shan Tennent sentenced Dennison to five months in jail.

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Understanding Natural Killers Could Lead to New Hepatitis Treatments
SourceURL:http://www.hhmi.org

Researchers have discovered that natural killer T (NKT) cells, the immune system's sentinels, patrol the labyrinthine blood vessels of the liver for invaders or signs of tissue damage and demonstrate a dogged behavior not seen before in other T cells.

The new studies show that NKT cells crawl along vessel walls, even upstream against blood flow. They halt only when they receive a chemical signal to unleash an immune-system assault on marauding microbes, other invaders or damaged tissue.

"In general, these NKT cells could have an important inflammatory role, particularly in the case of chronic hepatitis." --Dan R. Littman

The findings offer a new way of thinking about this important class of immune cell, which is responsible for the inflammation and cell death in the liver due to hepatitis. Hepatitis can be a reaction to viruses, parasites such as malaria or other infections. Learning to “call off” the NKT cell's pursuit and attack could offer a treatment for hepatitis and associated complications.

Natural Killer T Cells
The researchers, led by Dan Littman, a Howard Hughes Medical Institute investigator at New York University (NYU) School of Medicine, published their findings online on April 5, 2005, in the Public Library of Science Biology. Lead authors on the paper were Frederick Geissman in Littman's laboratory and Thomas Cameron in the laboratory of co-author Michael L. Dustin, also of NYU. Other co-authors were from the La Jolla Institute for Allergy and Immunology and Millennium Pharmaceuticals in Cambridge, Mass.

Although it was known that NKT cells were more prevalent in the liver than in any other organ, said Littman, it was not known how they accomplish the Herculean task of immune surveillance in the liver. The liver detoxifies and removes waste products from the blood. Inside the liver, vascular passages, or “sinusoids,” are filled with a witches' brew of nutrients, toxins, proteins, lipids and other chemicals. Thus, immune guardians that patrol the liver must tolerate many foreign molecules, yet respond readily to infection.

“It wasn't clear how NKT cells survey (tissue), or even if they survey at all,” said Littman. To visualize the activity of NKT cells in the liver, Geissman used mice in which NKT cells were tagged with a fluorescent marker. This was accomplished by replacing the gene encoding a characteristic NKT cell surface receptor called CXCR6 with the gene for green fluorescent protein. Although the CXCR6 receptor is known to be central to the function of NKT cells, its overall role was not known, said Littman.

Working with Geissman, Cameron adapted a technique called intravital fluorescence microscopy that enabled them to observe in real time the behavior of the tagged cells in the livers of mice.

“The startling discovery was that these NKT cells just move within the sinusoids intravascularly,” said Littman. By contrast, he said, immune cells in the lymph nodes and spleen perform their surveillance ensconced within specialized compartments shielded from the turmoil of the bloodstream. “In this case, it looks like NKT cells are doing their surveillance from within the vessels,” he said.

The observations revealed that the NKT cells crawl randomly within the sinusoids, even against blood flow, passing one another and even changing direction, said Littman. “It is very different from the kind of classical mechanism of lymphocytes rolling through vessels with the blood flow and when they are activated coming to a stop and then crossing through vessel walls in response to a signal.”

The researchers observed that the roving NKT cells stopped their movement when alerted by a foreign protein, called an antigen, “We think this is a reflection of their normal function of searching for antigen,” said Littman. “Whenever there is detection of antigen reflecting some kind of damage or local infection, the cell would stop in the vicinity of that signal and provide cytokine signals that would attract other inflammatory cells that destroy the invading microorganism and may also facilitate repair of the damage.”

In other experiments, the researchers explored the role of the CXCR6 receptor in the NKT cell's behavior. Receptors are protein sensors that nestle in the membranes of cells and detect external signaling molecules called ligands. When ligands are bound by the receptor, a specific chemical signal is transmitted to the interior of the cell.

In the case of NKT cells, the researchers found that the mice genetically rendered deficient in CXCR6 showed reduced survival of their NKT cells, but no change in the speed or pattern of their patrolling. The studies showed that the presence of CXCR6 prolonged the NKT cells' survival. The researchers also found that the NKT cells of CXCR6-deficient mice showed a reduced patrolling, as well as a decreased severity of artificially induced hepatitis.

“So, all the evidence we can obtain so far points to CXCR6 being involved in promoting survival of these NKT cells when they get into the environment of the liver, and that's how the cells tend to accumulate there,” said Littman.” Our data don't support a critical role of CXCR6 in crawling behavior of the cells.”

Evidence for the role of CXCR6 in the survival of NKT cells “as well as the cells' involvement in triggering hepatitis” suggests a possible clinical implication of the findings, said Littman. “In general, these NKT cells could have an important inflammatory role, particularly in the case of chronic hepatitis,” he said. “If that is the case, we speculate that it may be possible to manipulate the NKT cell, perhaps by interfering with CXCR6 function, to ameliorate the inflammatory process,” he said.

Still unknown, said Littman, is which antigens alert NKTs to infections, as well as the nature of the regulatory machinery of crawling and stopping. The chemical the researchers used in their experiment is a general immune activator and does not reflect what occurs during an actual infection, he noted. Such knowledge would offer important insights into the mechanism of inflammation and liver damage due to infections, he said.

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April 6th, 2005


Prognosis of Hepatocellular Carcinoma Established by Comparing Systems
SourceURL:http://www.gastrohep.com

April’s issue of Hepatology shows that performance status, tumor extent, liver function, and treatment are independent predictors of survival mostly in patients with cirrhosis and hepatocellular carcinoma.

Currently there is no consensus as to which staging system is best in predicting the survival of patients with hepatocellular carcinoma.

Dr Marrero and colleagues from Michigan conducted a study to identify independent predictors of survival and to compare 7 available prognostic staging systems in patients with hepatocellular carcinoma.

The investigators included a total of 239 consecutive patients with cirrhosis and hepatocellular carcinoma between 2000 and 2003.

The team determined demographic, laboratory, and tumor characteristics and performance status at diagnosis and before therapy.

Predictors of survival were identified using the Kaplan-Meir test and the Cox model.

The Barcelona Clinic Liver Cancer staging system had the best independent predictive power for survival – Hepatology

The investigators reported that 62% of patients had hepatitis C, 56% had more than 1 tumor nodule, 24% had portal vein thrombosis, and 29% did not receive any cancer treatment.

The researchers also noted that at the time of censorship, 63% patients had died and the 1 and 3 year survival of the entire cohort was 58% and 29%, respectively.

The independent predictors of survival were performance status, Model End Stage Liver Disease score greater than 10, portal vein thrombosis, and tumor diameter greater than 4 cm.

The research team showed that treatment of hepatocellular carcinoma was related to overall survival.

Furthermore, the researchers found that the Barcelona Clinic Liver Cancer staging system had the best independent predictive power for survival when compared with the other 6 prognostic systems.

Dr concluded, “Performance status, tumor extent, liver function, and treatment were independent predictors of survival mostly in patients with cirrhosis and hepatocellular carcinoma.”

“The Barcelona Clinic Liver Cancer staging system includes aspects of all of these elements and provided the best prognostic stratification for our cohort of patients with hepatocellular carcinoma.”

Hepatology 2005: 41(4): 707 – 715

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Hep C Compensation Vote on Hold
Canadian Press

Ottawa — A motion calling for compensation of "forgotten victims" of hepatitis C was prevented from going to a vote this week because officials wouldn't extend the Commons business day by two minutes.

The vote had been expected Wednesday, but now will be delayed for another 10 sitting days because of what critics say was a deliberate ploy to prevent another government embarrassment.

"This is absolute cruel, inhumane, cynical and full of hypocrisy on behalf of the federal Liberal government," victim Mike McCarthy said Wednesday.

The motion calls on the Commons to concur with the Commons health committee's recommendation on compensation of people infected with hepatitis C by tainted blood before 1986 or after 1990.

Those victims were excluded from a federal-provincial compensation deal for reasons now generally recognized as specious.

Under recently adopted Commons rules, a motion of concurrence receives a maximum of three hours' debate, and is voted on the following Wednesday.

Conservative MP Steven Fletcher, who put forward the motion on Monday, said the debate had just two minutes to go at 6:30 p.m., the normal end of the Commons business day. He said the session is usually extended briefly in such situations but in this case there was no extension.

"It's just maddening and frustrating, but the Liberals know the rules," said Mr. Fletcher. "If they know anything it's the rules, and they've used them continuously for their advantage."

A spokeswoman for government House Leader Tony Valeri denied there was any inflexibility.

"The rules were applied as they normally would apply in this situation," said Al Toulin. "I think the suggestion that we're inflexible or not trying to play by the rules is wrong."

It's not the first time a motion calling for compensation of the forgotten victims has been thwarted. Mr. Fletcher introduced a similar motion last fall that never came to a vote because the Liberals staged a filibuster.

Under the revised rules it is no longer possible to use that tactic and the vote will take place in about two weeks.

Several years ago a motion calling for compensation of the forgotten victims was defeated after then prime minister Jean Chrétien declared it to be a matter of confidence.

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Tampa Bay Hepatitis & Liver Disease Support Group Opens Chance Center

The Tampa Bay Hepatitis & Liver Disease Support Group Inc., a local 501c3 organization, is proud to announce the opening of The Chance Center, an education and resource center for people living with hepatitis & other liver diseases.

The Chance Center is named in honor Leroy Choina, of one of Tampa Bay Hepatitis & Liver Disease Support Group's members who passed away in 2002 from complications of Hepatitis B & C. Leroy was unable to get the medical care he needed in time to save his liver, and his disease progressed to cancer. Leroy's grandson, Chance, also has hepatitis C, as does his daughter, mother, and several other relatives. We hope that by increasing awareness of this epidemic, Chance (the grandson) and all others will be able to receive the treatment, medical care, and support needed to fight this disease.

With over 36,000 people affected by Hepatitis c in Hillsborough and Pinellas alone, the Chance Center will be able to help many of these people educate themselves about their illness, offer support, and network with others to find affordable medications & medical care for the uninsured and working poor. The typical treatment for hepatitis C is a chemotherapy-like drug that is taken for a year. The medication is expensive; average costs are between $25,000-30,000 for a year, and people without insurance are not given the opportunity to effectively battle this illness due to the prohibitive costs. The Chance Center will give these people a chance to win the battle against this silent killer, regardless of insurance or income.

The center is run completely by volunteers. The center's director, Debbie Barnes, is a transplant recipient who found out she had Hepatitis C after a blood transfusion. The founder of the Tampa Bay Support Group, Don Vauiso, is a liver transplant recipient whose transplant was performed 12 years ago on the date of the center's opening. The group relies on fundraising and donations to keep the center in operation.

The Chance Center is located at 5702 Gulfport Blvd. , Gulfport FL. For more information, please contact Cindy Runyon, Vice President, or Debbie Barnes, Center Director at 727-384-1024.

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Hep C Vote: Liberals Can Right a Wrong
Source: Windsor Star

Seven years ago this month, Jean Chretien's Liberal government endorsed a tainted-blood compensation package that excluded as many as 6,000 sick and dying hepatitis C victims.

Now Paul Martin's Liberal government has a chance to right that wrong. It's expected the House of Commons will vote today on a Conservative motion to extend full compensation to sufferers infected outside a four-year window designated in 1998.

With all three opposition parties backing it, the motion is expected to pass no matter how the Liberals vote. And the motion itself carries no legal weight.

But that doesn't matter. The motion carries so much moral weight the Liberals should vote in its favour then act to extend compensation immediately.

To their credit, the Liberals announced in November plans to re-open negotiations with lawyers for the uncompensated victims. But little seems to have transpired since then.

What are the Liberals waiting for? Forgotten hepatitis C victims are getting sicker, even dying, as precious time wastes away.

In 1998, the Chretien Liberals created a $1.1-billion compensation fund for victims of the tainted-blood tragedy. It limited access to the pot to Canadians infected between 1986 and 1990 on the grounds an available test to detect what was then called non-A, non-B hepatitis wasn't used in Canada during that period.

American blood banks started ordering the tests in 1986, but, as the 1997 Krever report on the blood scandal concluded, Canadian federal, provincial and Red Cross bureaucrats quibbled over the efficacy of the tests and their $10-million-a-year price tag until 1990.

When Chretien's government approved the compensation package, it insisted there was no way to detect non-A, non-B hepatitis – or hepatitis C, as it was officially labelled in 1989 -- before 1986.

So amidst wildly exaggerated claims that compensating all victims would "bankrupt" medicare, the Chretien government limited compensation to the period during which it and the Canadian Red Cross were unquestionably at fault.

It later added a $300-million "care instead of cash" fund for victims infected outside the window. That money was apparently transferred to the provinces, but victims say they've yet to receive a cent.

Critics rightly slammed the Liberals' approach as heartless. Bad blood transfusions left thousands of innocent Canadians with a debilitating, sometimes deadly, liver disease. Even if the government wasn't legally liable, it should have compensated pre-1986 victims. It was the right thing to do.

That said, evidence has emerged since 1998 that an indirect test for non-A, non-B hepatitis was available as early as 1981. Called the ALT test, it detected abnormally high levels of a liver enzyme and predicted the presence of the new hepatitis strain roughly 30 per cent of the time.

A panel of U.S. experts, including representatives of the National Institutes of Health and the American Association of Blood Banks, recommended in 1981 that all donated blood be subjected to the ALT test. No Canadians were at the meeting, but documents obtained by the Kansas City Star in 2003 reveal Canadian Red Cross brass were well aware of its conclusions.

This new evidence, combined with word the $1.1-billion compensation is still flush with cash, should spur the Liberals to act immediately. They can still do the right thing.

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April 8th, 2005


Assessment of Sexual Functions in Patients with Chronic Liver Disease
SourceURL:http://www.gastrohep.com

The most recent release of the International Journal of Impotence Research finds that sexual functions do not appear to be affected by stable chronic liver disease.

Dr Aslan and colleagues from Turkey determined sexual problems and the prevalence of erectile dysfunction in patients with chronic liver disease by means of International Index of Erectile Function.

The investigative team included a total of 81 patients with stable chronic liver disease.

The team grouped the patients as mild to moderate (n=10), with chronic Hepatitis B, C and D (n=28) and Hepatitis carriers (n=43) according to the type of their chronic liver disease.

The prevalence of any erectile dysfunction was 51% for all patients – International Journal of Impotence Research

The researchers asked all patients to complete a questionnaire including International Index of Erectile Function and demographics.

The International Index of Erectile Function domain scores were calculated and erectile dysfunction grading was determined on erectile function domain.

The investigators compared the International Index of Erectile Function domain scores between these groups.

The mean age of the patients was 55 years.

Using the International Index of Erectile Function, the researchers established that the prevalence of any erectile dysfunction was 51% for all patients, and 50%, 50%, and 51% for cirrhosis, chronic hepatitis and carriers, respectively.

Dr Aslan concludes, "The International Index of Erectile Function domain scores were not significantly different among the patient groups."

"Sexual functions did not appear to be affected by the stable chronic liver disease."

Int J Impot Res 2005; doi:10.1038/sj.ijir.3901316

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Transition Therapeutics Receives Approval to Initiate Hepatitis C Phase I/II Clinical Trial
SourceURL:http://www.newswire.ca

TORONTO, April 7 /CNW/ - Transition Therapeutics Inc. ("Transition") (TSX: TTH) announced today that it has received approval from Health Canada for a Phase I/II clinical trial in hepatitis C patients with its Interferon Enhancing Therapy, HCV-I.E.T.

The clinical trial is designed to evaluate HCV-I.E.T.'s ability to produce a positive therapeutic response in patients who have failed to respond to previous treatment with the current "gold standard" hepatitis C therapies consisting of interferon and ribavirin. This population of hepatitis C patients currently has no treatment alternatives and is estimated to represent nearly 45% of all hepatitis C patients.

"Our HCV-I.E.T. therapy is designed to treat hepatitis C patients who currently have no form of treatment available. This patient population is predisposed to life-threatening complications of severe liver damage, potentially requiring liver transplantation in the future." said Dr. Tony Cruz, Chairman and CEO of Transition "An effective therapy for this patient population would be of great value."

HCV-I.E.T. combines Transition's interferon enhancer, EMZ702, with the current standard of care for hepatitis C, a combination therapy of interferon alpha and ribavirin. EMZ702 has an excellent safety profile and the combination of EMZ702 with interferon and ribavirin in surrogate models for hepatitis C has demonstrated a two to three fold increase in anti-viral potency compared to interferon and ribavirin alone. This potency was sufficient to rapidly advance EMZ702's clinical development into hepatitis C patients.

The Phase I/II study will be conducted in centres across Canada. Patients will receive twice-weekly treatments of EMZ702 administered in combination with standard interferon-alpha and ribavirin therapy for a period of 12 weeks.

Among many endpoints, the primary efficacy endpoint will be the reduction of HCV RNA viral load, a clinical endpoint indicative of positive response to therapy. Transition expects to have interim data in the fourth quarter of 2005.

Interferon Enhancing Therapy is a key development initiative for Transition and has resulted in the discovery and development of two drug products: MS-I.E.T. for multiple sclerosis ("MS"), which is currently in phase II studies in patients with MS, and HCV-I.E.T. for hepatitis C, which has been approved for a Phase I/II clinical trial. Transition's interferon enhancers have demonstrated more potent anti-viral and anti-proliferative effects than interferon alone and may also have application in various forms of cancer and in hepatitis B. Worldwide sales of interferon products are estimated to be in excess of US$ 5 billion annually.

About Hepatitis C
Hepatitis C is a progressive disease of the liver caused by the hepatitis C virus. Currently, it is estimated there are about 170 million people worldwide who are infected with the hepatitis C virus, and 4 million of those are in the United States. Up to 80% of individuals infected with the virus are symptom-free initially, as the infection is typically mild in its early stages. As a result, diagnosis does not usually take place until liver damage has already occurred. Long-term effects of chronic hepatitis C infection include cirrhosis, liver failure and liver cancer. Current treatments for hepatitis C, including combination therapies, can eliminate the virus in approximately 55% of hepatitis cases.

About Transition
Transition is a product-focused biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include regenerative therapies E1-I.N.T.(TM) and GLP1-I.N.T.(TM) for the treatment of diabetes, MS-I.E.T. for the treatment of multiple sclerosis and HCV-I.E.T. for the treatment of hepatitis C. Transition has commenced a Phase II clinical trial for MS-I.E.T. in patients with multiple sclerosis, has received clearance to initiate exploratory Phase IIa clinical trials to evaluate efficacy, safety, and tolerability of E1-I.N.T.(TM) in both type I and type II diabetes patients and has received approval to commence a Phase I/II clinical trial for HCV-I.E.T. in patients with hepatitis C.

Transition's shares are listed on the Toronto Stock Exchange under the symbol "TTH".

Notice to Readers: Information contained in our press releases should be considered accurate only as of the date of the release and may be superseded by more recent information we have disclosed in later press releases, filings with the OSC or otherwise. Press releases may contain forward-looking statements based on the expectations of our management as of the date of the release. Actual results may materially differ based on many factors, including those described in the press releases.

For further information: on Transition, visit www.transitiontherapeutics.com or contact:

Dr. Tony Cruz, Chief Executive
Officer, Transition Therapeutics Inc., Phone: (416) 260-7770, x.223,
tcruz@transitiontherapeutics.com;

Catherine Auld, Chief Financial Officer,
Transition Therapeutics Inc., Phone: (416) 260-7770, x.224,
cauld@transitiontherapeutics.com

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April 9th, 2005


Ban Stymies Blood Probe Clark Backs Papers Secrecy
By YVONNE MARTIN

Haemophiliacs investigating the "bad blood scandal" of the 1990s have been stymied by a 30-year embargo placed on sensitive documents from Prime Minister Helen Clark's time as health minister.

The discovery was made when the Haemophilia Foundation tried to access documents through Archives New Zealand last month.

Foundation spokesman Mike Carnahan found documents dating back to Clark's time as minister (1989-90), and beyond, were embargoed until January 1, 2020. Others were restricted for Clark's lifetime.

A spokesman for Clark says it is standard practice for such documents to be classified and that would continue.

But Carnahan, who is unsatisfied with the secrecy surrounding the archives, wants the embargo lifted.

"You have to wonder why the documents have such restrictions placed on them," he said.

"The haemophilia community has had to cope with scares about HIV, CJD and hepatitis C. We are always cautious about the next virus and this attempt to cover up the facts tells me our concern is wholly justified."

Before blood screening was introduced, more than 170 haemophiliacs contracted hepatitis C after using products made from donated blood.

Blood screening was commercially available in 1990, but not introduced in New Zealand for another two years.

Hepatitis C is a potentially fatal virus that attacks the liver, leading in chronic cases to cirrhosis (scarring) and cancer.

Carnahan wants access to politicians' documents, including those of Clark and National's Simon Upton who replaced her as minister, to unravel the truth behind the tainted blood saga.

The foundation plans to write to Clark, asking her reasons for the embargo and requesting it to be lifted for nominated persons. The Health Ministry had been unable to answer many of the foundation's questions because it lacked access to records, said Carnahan.

"We need to have a look at the papers because what we are trying to do throughout all this is to understand what happened," he said.

"Above all, we don't want to tread the same path again."

A spokesman for Clark said Archives New Zealand encouraged senior politicians to store their material for historical purposes.

"I am told it is standard practice for access to such material to be restricted either for 25 years or for the lifetime of the politician," he said. "Such restrictions apply to all Helen Clark's papers, and will continue to do so."

A request to lift the embargo would be refused, he said.

In contrast, Labour's Mike Moore, who was Opposition leader in the early 90s, has granted Carnahan permission to view his documents from that era. Moore said in 1992 that the delays in screening blood for hepatitis C would prove to be the biggest medical scandal in New Zealand's history.

Upton has yet to respond to a request to open his files.

The limited access to documents is the latest blow for the haemophiliac community, which was badly hit by the hepatitis C virus.

An investigation by The Weekend Press a year ago found that despite the high infection rate, the haemophilia community has been effectively barred from a Government compensation offer because of difficulties proving when they were infected.

To qualify for $44,000 compensation, claimants must prove infection between 1990 and July 1992, when testing began.

Little has changed in the last year, said Carnahan. Of 171 haemophiliacs with hepatitis C, fewer than five have qualified for the Government's offer.

Similarly, only 40 per cent of those affected have qualified for ACC cover.

Recompense will be high on the agenda when haemophiliacs meet for their national conference in Wellington next weekend.

International speakers will be World Haemophilia Federation president Brian O'Mahony, a bio-chemist who played a key role in victory for compensation for Irish haemophiliacs infected with HIV and hepatitis C.

An Irish medical compensation expert, Raymond Bradley, will also speak.

The conference will update members on treatments. Until recently, few haemophiliacs who became infected with hepatitis C before 1992, had been offered treatment.

The Press revealed last month that Canterbury's most expensive patient was a haemophiliac who cost $2.1 million in 21 months.

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