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Alan Franciscus
Editor-in-Chief
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In This Issue:
• China’s First
Therapeutic Vaccine of Hepatitis B into Clinical Trials
• Endoscopic Management of Biliary Complications
After Adult Living Donor Liver Transplantation
• Hepatitis No Bar to 2100km Trek
• Health: Effect Routine Vaccination Against
HBV Now, FG Told
• Normal Protein Diet for Episodic Hepatic
Encephalopathy
• Glaxo Given 'Serious' Warning on False
Vaccine Information
• Donald R. Sellers Resigns as President
and CEO of SciClone
• Wits Trying to Inactivate Hepatitis B
Virus
• Schering to Pay $350 Million for Medicaid
Fraud
• Hepatitis C Outbreak Adds a New Woe
to Drug Centers
July 12th, 2004
China’s
First Therapeutic Vaccine of Hepatitis B into Clinic Trial
Source: www.chinaview.cn
BEIJING, (Xinhuanet) -- China’s
first therapeutic Hepatitis B vaccine, which will make possible
for Hepatitis B carriers and patients to be cured, has been
approved for a second phase of clinical trials.
So far 261 patients have successfully overcome the disease
with the help of the therapeutic vaccine. CRIENGLISH.com reported
Monday.
70 percent of patients in the immune clearance phase, which
usually occurs later in life, can be cured if vaccinated on
time.
However, patients in the immune tolerant phase, which usually
takes place at a young age, still show some resistance to
the new treatment.
The therapeutic Hepatitis B vaccine is an albumen vaccine.
Two other potential vaccines, including DNA and polypeptide
types are also being developed and are expected to be ready
for use in five to six years.
(CRIENGLISH.com)
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July 13th, 2004
Endoscopic
Management of Biliary Complications after Adult Living Donor
Liver Transplantation
Source: www.gastrohep.com
Living donor liver transplant is associated
with more biliary complications than cadaveric liver transplant
finds a study in the American Journal of Gastroenterology.
Biliary complications and their management in living donor
liver transplantation (LDLT) are not well characterized, despite
the opposite being the case in adult cadaveric liver transplantation
(CLT).
Janak N. Shah and colleagues have now assessed the role of
endoscopic retrograde cholangiopancreatography (ERCP) in the
diagnosis and management of biliary complications following
LDLT.
They performed a retrospective cohort analysis of all LDLT
recipients with duct-to-duct anastomoses (n = 15).
Specific data they collected included referral for ERCP, diagnosis,
and therapy.
Comparisons were then made to a cohort of 260 CLT recipients.
The research showed that a greater percentage of LDLT recipients
underwent ERCP (73%) than did CLT recipients (25%).
As diagnosed by ERCP, biliary complications were also more
frequent in LDLT recipients than in CLT recipients.
Such complications consisted of leaks and strictures and were
diagnosed in 53% and 12%, and 27% and 5% of LDLT and CLT patients
respectively.
The majority of leaks occurred at T-tube sites (LDLT: 87%;
CLT: 65%).
Diagnosis and therapy of leaks required a median of 2 ERCP
procedures in both groups.
However, bile leaks were successfully treated endoscopically
in 100% and 84% of LDLT and CLT recipients, respectively.
In the case of strictures, diagnosis and treatment occurred
with a median of 1.5 procedures for LDLT recipients and 2
procedures for CLT recipients.
Biliary complications were more common in LDLT recipients
than CLT recipients.-- American Journal of Gastroenterology
The duration of endoscopic therapy was a median of 10 and
14 wk, and success rates were 75% and 62% in LDLT and CLT
groups, respectively.
Commenting on their findings, the researchers said that their
study showed that LDLT is associated with increased biliary
complications as compared to CLT.
They added that, “ERCP is useful for diagnosis, can
successfully treat most LDLT-related biliary complications,
and should be attempted prior to more invasive interventions.”
Am J Gastroenterol 2004; 99 (7): 1291 - 1295
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Hepatitis
No Bar to 2100km Trek
Juliet Rowan
Source: Herald Feature: Health
Cycling the length of New Zealand and kayaking
across Cook Strait in the middle of winter are feats even
the hardiest of souls might not attempt, let alone someone
with potentially life-threatening diseases.
But Jack Finn, who suffers from haemophilia and hepatitis
C, wants to show that living with serious medical conditions
does not have to be a barrier to achieving goals.
The 21-year-old Aucklander left Cape Reinga yesterday to cycle
and kayak the 2100km to Bluff.
“The journey is about showing people that you can do
all sorts of things even though you are living with a medical
condition,” he said.
He also hopes to raise awareness of haemophilia and the bad
blood crisis of the early 90s, when he and other haemophiliacs
were infected with hepatitis C or HIV from contaminated blood
products.
Mr Finn, travelling with a support crew of three friends in
a campervan, will cycle from the Far North to Devonport, then
kayak to Mechanics Bay in central Auckland.
He expects a crowd of about 100 people, many supporters from
the haemophilia community, to meet him there on Sunday.
From Auckland, he will make his way down the North Island
to Palmerston North, where he will be joined on the bike ride
by his 78-year-old grandfather, who also has haemophilia and
hepatitis C.
In Wellington, Mr Finn will deliver a letter to Parliament
asking the Government to step up efforts to help the 70 per
cent of haemophiliacs infected with hepatitis C during the
bad blood crisis.
An estimated 700 people contracted the virus, which attacks
the liver and can lead to cancer, in the crisis.
Haemophiliacs were among the worst affected because of their
need for regular transfusions and blood products.
At least four have died from the disease in the last three
years.
In 2000, the Government set aside $7 million to compensate
the 700 infected people after acknowledging it had failed
to introduce screening tests to detect hepatitis C until 1992,
two years after such tests became available. Those applying
for the compensation scheme’s individual payouts of
$44,000 must prove they were infected between February 1990
and July 1992, something very few haemophiliacs have been
able to do.
“It’s an ongoing battle with the Government to
get some form of apology and compensation,” Mr Finn
said.
Overseas, haemophiliacs with hepatitis C or HIV contracted
from bad blood have received up to $460,000 each in Government
compensation.
For Mr Finn, having hepatitis C has meant dealing with symptoms
such as stomach aches and chronic fatigue on top of the bleeding
injuries associated with haemophilia.
Haemophilia is a disorder in which vital clotting agents are
lacking in the blood.
It is a genetic condition, passed down by females to their
sons, and affects about one in 10,000 males born in New Zealand.
Mr Finn suffers from the mild form, which requires treatment
with human or artificial clotting agents when there is injury.
Severe haemophiliacs can get spontaneous bleeds, needing transfusions.
As a child, he endured more than a dozen visits to hospital
every six months for gum bleeds.
Contrary to popular belief, internal bleeding rather than
cuts or scrapes cause the greatest problems for haemophiliacs.
But despite his pain, and having watched fellow haemophiliacs
die of hepatitis C and HIV, Mr Finn refuses to let the condition
hold him back.
This year, he became the first haemophiliac to graduate from
the two-year Diploma in Outdoor Recreation Leadership at Auckland
University of Technology.
Bad blood crisis
An estimated 700 people contracted the hepatitis C virus,
which attacks the liver and can lead to cancer.
At least four have died from the disease
in the last three years.
The Government has set aside $7 million
to compensate infected people after acknowledging it had failed
to introduce screening tests to detect hepatitis C until 1992,
two years after such tests became available.
Overseas, haemophiliacs with hepatitis
C or HIV contracted from bad blood have received up to $460,000
each in Government compensation.
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Health:
Effect Routine Vaccination Against HBV Now, FG Told
Source: Vanguard (Lagos)
The Federal government has been called
upon to effect the inclusion of the hepatitis B vaccination
against the hepatitis B virus (HBV), the commonest cause of
liver cancer in the Nigeria, as part of routine immunisation
schedule in the country. Making the call last week during
a courtesy visit to Vanguard, by a delegation from GlaxoSmithKline
Pharmaceuticals, Head of the Morbid Anatomy Dept. Obafemi
Awolowo University Teaching Hospital (OAUTH), Ile-Ife, Prof.
Segun Ojo said government had no option other than to fund
the programme.
According to Ojo, who is President of the
Association for the Study of the Liver in Nigeria (ALSN) said:
“HBV vaccination should be part of the routine immunisation
schedule. Although there is government approval that the immunisation
should be routine, it exists only on paper. A lot more needs
to be done, and government should commit more funds to this
programme which should also be part of the employment package
of every employee.”
Further, he noted that currently, prevention
is the best resort in controlling the spread of the virus
in the country. One of the main problems is lack of awareness.
What is required is the right education,” he asserted.
Meanwhile, amidst reports that no fewer
than 75 per cent of Nigerians are exposed to the hepatitis
B virus,the Society holds an international workshop as part
of activities to fight the scourge of the disease in the country
today. Sponsored by multinational pharmaceutical giant, GlaxoSmithKline,
the workshop aims to provide better understanding of the disease
to the various experts and professionals involved in its study
and management.
The event comes up at the NICON-Noga Hilton
Hotel, Abuja and will be attended by experts in the research
and treatment of liver diseases from different parts of the
world. It was preceded yesterday by the national conference
of the association deliberating strategies towards a nation-wide
enlightenment campaign to draw attention of Nigerians to the
HBV scourge.
It is estimated that 40 per cent of Nigerian
children would have been infected by the HBV virus by age
two while as high as 90 per cent would have been infected
by age 10, 20 per cent of who are likely to become chronic
carriers.
“Hepatitis B is responsible for about
80 per of all liver cancer and more cases of liver cirrhosis.
One person in six in the world—mostly in the developing
countries like Nigeria—has been infected with the disease
and approximately 300 million are chronic carriers.
The virus is incurable (although the body
may rid itself of the infection) and is transmitted in similar
ways like HIV. HBV is also transmitted by skin lesions, which
are the main means of transmission in children.
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July 14th, 2004
Normal
Protein Diet for Episodic Hepatic Encephalopathy
Source: www.gastrohep.com
Restricting the protein content of diets
fed to cirrhotic patients during episodes of encephalopathy
has no beneficial effect, suggests a study in the latest issue
of the Journal of Hepatology.
Protein-restricted diets are often prescribed for cirrhotic
patients with hepatic encephalopathy. Yet protein restriction
may lead to a worsening of nutritional status, without leading
to any improvement of hepatic encephalopathy.
Juan Córdoba and fellow researchers from Barcelona,
Spain, have therefore conducted a study to assess the effects
of the amount of protein in the diet on the evolution of episodic
hepatic encephalopathy.
They studied 30 cirrhotic patients admitted to hospital due
to an episode of encephalopathy. The patients were randomized
to receive either a low-protein diet with progressive increments
or a normal diet for 14 days, in addition to standard measures
to treat hepatic encephalopathy.
Protein synthesis and breakdown were then studied at day 2
and day 13 with the glycine-N15 infusion method.
Using this technique the researchers found there was no significant
difference in the outcome of hepatic encephalopathy between
the two treatment groups.
Although protein breakdown was greater in those patients receiving
the low-protein diet, both groups showed similar levels of
protein synthesis, regardless of whether they were fed a low
or a normal protein diet.
The researchers conclude that diets with a normal content
of protein, which are metabolically more adequate, can be
safely administered to cirrhotic patients with episodic hepatic
encephalopathy.
They add that restriction of the content of protein of the
diet does not appear to have any beneficial effect for cirrhotic
patients during an episode of encephalopathy.
J Hepatol 2004; 41 (1): 38 – 43
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Glaxo
Given 'Serious' Warning on False Vaccine Information
Heather Tomlinson
Source: The Guardian
UK drugs company GlaxoSmithKline has been
accused of creating a "serious public health concern"
by regulators over its labelling of hepatitis and flu vaccines
in the US.
The food and drug administration, the American
regulatory body, sent a warning letter to the firm over its
actions this month. It said it had given "false and misleading"
information about who should take flu vaccines during the
peak winter season, and also did not detail the risks of taking
the vaccines Engerix-B, against hepatitis B, Havrix (hepatitis
A) and Twinrix (both viruses).
It ordered the firm to correct the information
and send it to all those who had seen the false promotional
material, "because the violations described above are
serious".
The warning letter is particularly embarassing
for the firm at a time when it is being sued by New York state
attorney general Eliot Spitzer over its handling of clinical
trials for Seroxat, the antidepressant. It is alleged that
GSK hid negative information about its safety and effectiveness.
According to the FDA, a summary of information
on hepatitis vaccines distributed by Glaxo said it was safe
to give flu vaccines to children between six months and five
years old and to pregnant women, which is not true. It also
failed to reveal safety information about the hepatitis vaccines,
such as adverse reactions like fatigue and headaches and failed
to warn about potential sensitivity to yeast and the antibiotic
neomycin which is in some of the vaccines.
"The summary [of immunisation information]
creates a serious public health concern because it could lead
to incorrect administration of the live attenuated influenza
vaccine to individuals, including pregnant women with medical
conditions and children from six months to up to five years
old, for whom that product has not been demonstrated to be
safe and effective," the letter said. "In addition,
this summary was distributed during the height of the flu
season with false and misleading in formation regarding the
live attenuated influenza vaccine."
The FDA routinely sends warning letters
to firms in the drugs trade but rarely issues such a strong
rebuke to the big pharmaceuticals firms. In 2002 it issued
a warning to Glaxo over manufacuturing processes in two Puerto
Rican factories, and it is still investigating.
GlaxoSmithKline did not return calls for
comment at the time of going to press.
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Donald
R. Sellers Resigns as President and CEO of SciClone
Source: Business Wire
SAN MATEO, Calif.---SciClone Pharmaceuticals,
Inc. (Nasdaq:SCLN) today announced that Don Sellers has resigned
as President and CEO of the Company after 11 years of service.
Mr. Sellers also has resigned from the Board of Directors.
However, he will continue to act as a consultant to the Company.
The Board of Directors is actively working to identify a successor.
In the interim, Alfred Rudolph, M.D., COO, and Richard Waldron,
CFO, will form an Office of the President to guide the Company
along with the Board's continuing oversight.
Mr. Sellers joined SciClone in 1993 to
help establish the global presence of SciClone. In 1996, he
was appointed President and CEO and elected to the Board of
Directors. Under Mr. Sellers' leadership, SciClone has successfully
established its operations of sales to China, and its international
marketing efforts, introduced its lead product, ZADAXIN(R),
into phase 3 trials, and improved its balance sheet through
a number of financings.
"I am extremely excited about the
future of SciClone and very comfortable that the company will
be in the capable hands of the corporate officers and the
Board of Directors," noted Sellers. He added, "My
years with SciClone have been some of the most interesting
and rewarding of my 30 years in the pharmaceutical industry
and I am proud to have had a role in building a unique and
promising company."
Jere Goyan, Ph.D., SciClone's Chairman
of the Board observed, "Over the years, Don's efforts
have been key to building SciClone into the Company it is
today. His past efforts provide us a strong base from which
to create the Company's future."
SciClone Pharmaceuticals is a biopharmaceutical
company engaged in the development of therapeutics to treat
life-threatening diseases. SciClone is currently evaluating
its lead product ZADAXIN in several clinical trials, including
two phase 3 hepatitis C clinical trials in the U.S., a completed
phase 3 hepatitis B clinical trial in Japan, a phase 2 malignant
melanoma clinical trial in Europe, two phase 2 liver cancer
pilot studies in the U.S., a hepatitis C triple therapy open-label
clinical trial in Mexico, and a hepatitis B combination therapy
trial in Taiwan. SciClone recently announced plans for a ZADAXIN
phase 3 hepatitis C triple therapy clinical trial in Europe.
The Company's other principal drug development candidate is
SCV-07, a potentially orally available therapeutic to treat
viral and infectious diseases.
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July 15th, 2004
Wits
Trying to Inactivate Hepatitis B Virus
Source: www.iol.co.za
Wits University is hoping to pinpoint the
gene sequences that inactivate the virus that causes hepatitis
B, an illness carried by over 380 million people worldwide,
the university said on Thursday.
In a statement ahead of hepatitis Day on Friday, Wits said
that it is using new technology to try to stop hepatitis B
from recurring in the body and had already submitted some
of the aspects of the study for patenting.
According to Professor Patrick Arbuthnot,
head of the Wits hepatitis B virus (HBV) research programme,
approximately 25 percent of the world's chronic carriers of
the virus will develop liver cancer.
"HBV is endemic to sub-Saharan Africa,
east and south east Asia and the western Pacific islands where
it is one of the key environmental risk factors that predisposes
chronic carriers to liver cancer and cirrhosis.
"When compared, the link between hepatitis
B and liver cancer is at least as strong as that between smoking
and lung cancer," he said in a statement.
He said it was accepted that the virus
alters the gene properties in human liver cells to cause cancer
- in South Africa this usually develops during early adulthood
and has a particularly grave prognosis.
Most patients die within three months of
diagnosis of the malignancy.
"There is definitely a need for the
development of a new treatment of HBV to prevent the serious
complications of chronic infection with the virus."
About five percent of babies born in sub-Saharan
Africa are vaccinated against the virus but it is not effective
for people already infected.
He said existing drugs were largely ineffective
in sub-Saharan Africa because they are designed to treat patients
in whom the virus replicates rapidly and in sub-Saharan Africa,
the rate of replication of the virus is slower.
"The ultimate goal is to find an effective
treatment for hepatitis B for people living in sub-Saharan
Africa," Arbuthnot said.
The team expects to know within about two
years whether the therapy will work or not. - Sapa
Published on the Web by IOL on 2004-07-15
09:48:01
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July 16th, 2004
Schering
to Pay $350 Million for Medicaid Fraud
Source: www.NJ.com
Schering-Plough, the struggling Kenilworth-based
drug maker, has agreed to pay $350 million in fines and plead
guilty to criminal charges in connection with a federal investigation
into Medicaid fraud, according to a published report.
A settlement is expected to be announced
next week by federal prosecutors in Philadelphia, according
to an account in the New York Times.
Last year, Schering-Plough raised to $500
million the amount it has set aside to settle federal investigations
in Massachusetts and Pennsylvania into its marketing practices.
Earlier this year, Schering-Plough agreed
to pay $27 million to settle lawsuits filed by the federal
government and the state of Texas alleging the drug maker
overcharged Medicaid, the government health program for the
poor, for prescription medicines.
The overcharging occurred from 1995 to
2001.
Two years ago, Schering-Plough agreed to
pay a $500 million fine as part of a settlement with the Food
and Drug Administration involving manufacturing problems at
its plants in New Jersey and Puerto Rico. Schering-Plough,
best known for the allergy medicine Claritin, has been hurt
by declining sales of key products and a series of government
investigations.
Last year, the company hired a new chairman
and chief executive officer, Fred Hassan, who has been trying
to engineer a turnaround.
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July 17, 2004
Hepatitis
C Outbreak Adds a New Woe to Drug Centers
Alan Feuer
Source: New York Times
As one of the largest residential drug treatment centers in
the city, Palladia Starhill cares for people already suffering
from a raft of problems: drug addiction, mental illness, lack
of education, H.I.V. infection, sometimes full-blown AIDS.
Now, officials at the Bronx center say,
a new crisis is beginning to complicate, even endanger, their
work: treating hepatitis C.
In the last year, hepatitis C, an insidious
illness that destroys the liver, has been diagnosed in 114
of Palladia Starhill's 400 patients.
The outbreak, officials say, has left drug
abusers unable to concentrate on the hard work of breaking
their addiction. It has also cost the short-of-cash center
nearly $500,000. One staff member has died of the disease.
"It's one more thing for us to deal with and focus on,"
said James Hollywood, senior director of the center, on Macombs
Road in the Mount Eden section of the Bronx. "People
come here to deal with their addictions, but they end up dealing
with this serious medical issue as well."
To confront the hepatitis C cases, Palladia
Starhill has begun working with a medical clinic at the center,
Project Samaritan Health Services, to establish an unusual
program. Palladia Starhill has gone beyond its role as a drug
treatment center and now screens each patient for hepatitis
C and helps those afflicted pursue a long-term cure - a process
that can take up to 48 weeks.
"We are one of the very few drug treatment providers
around that has such a comprehensive program," said Marguerite
Gebhardt, Project Samaritan's executive director.
The program was established last year,
said Ms. Gebhardt, soon after the State Office of Alcoholism
and Substance Abuse Services published a report on hepatitis
C, recommending that drug treatment centers begin testing
patients.
Jennifer Farrell, a spokeswoman for the
office, said it has confronted the prevalence of viral hepatitis
at drug treatment centers by establishing a task force called
the Addiction Medicine Unit. She said the office also holds
symposiums, teleconferences and other events to educate the
public about hepatitis C.
Ms. Gebhardt said that Project Samaritan
had independently concluded that hepatitis C was a growing
problem because so many addicts at Palladia Starhill had complained
of symptoms of the disease.
She added that hepatitis C, which is often
spread through intravenous drug use, has long been a problem
among addicts but that treatment centers are just beginning
to understand how extensive it has become.
"It's been there all along, but it's
been a silent problem," Ms. Gebhardt said. "We realized
that we were on the cusp of a brand-new epidemic that was
potentially larger than H.I.V."
Currently, between 20 and 25 percent of
patients at Palladia Starhill are infected with hepatitis
C, compared with 30 percent infected with H.I.V., Mr. Hollywood
said. But hepatitis C infections could easily overtake H.I.V.
infections among drug users, he added, because drug use can
expedite its spread.
Complicating matters is the fact that 70
percent of Palladia Starhill's patients have spent time in
the state prison system, which is rife with hepatitis C. According
to prison officials, about 9,250 state inmates have hepatitis
C. About 5,500 inmates are H.I.V.-positive.
Juan Vega, 52, discovered that he had hepatitis
C two years ago while living at Palladia Starhill. He had
gone there to fight off heroin addiction. Suddenly, he found
himself fighting off disease.
His drug treatment, which included hours
of group therapy and performing odd jobs, was hampered by
the side effects of his hepatitis medication. There were headaches,
nausea, depression and fatigue. "It was difficult,"
Mr. Vega said. "The drugs didn't even come into play
in my mind. I had to focus on my liver."
Palladia Starhill treats hepatitis C with
a regime of 50 pills and an injection of a drug called interferon
every week. But some addicts are loath to take the injections,
officials said, because the needles are frighteningly reminiscent
of their days of taking drugs.
"We've had clients who used to shoot
up, and the injections give them flashbacks," said Otilia
Phillips-Drakes, the center's medical director.
Drug treatment centers have long been places
where societal problems collect. In the 1970's and 80's, Mr.
Hollywood said, Palladia Starhill established a mental-illness
counseling program to replace the city's program, which was
slowly dismantled. When the AIDS epidemic occurred, he said,
the treatment center set up medical and support programs to
deal with that disease.
Now, Mr. Hollywood said, hepatitis C has
emerged, and it is distracting the staff of the treatment
center from its primary job: helping people get off drugs.
"By design, we're not set up as a
medical facility," Mr. Hollywood said, "but we're
dealing with an ever-increasing medical problem."
Ms. Gebhardt, for one, says that drug treatment
centers should seize the chance to treat people infected with
hepatitis C. Where else, she said, could doctors and nurses
find people, in a controlled environment, sick with a fatal
but curable disease?
"In some ways," she added,
"this is such a golden opportunity."
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