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Alan Franciscus
Editor-in-Chief
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In This Issue:
Prometheus Laboratories Introduces
FIBROSpect(SM) II
Schering-Plough Announces
Availability of Rebetol Oral Solution for Use in Treating
Pediatric Hepatitis C
Officers Being Monitored
After Being Bitten by Inmates
Colorado Organ and Tissue
Donor Registry Sees Unprecedented Growth
InterMune Announces Results
of Exploratory Phase II Study Of Interferon Gamma-1b in Advanced
Liver Fibrosis
Weight Gain After Transjugular
Intrahepatic Portosystemic Shunt
Occult Hepatitis B Virus
Infection Still Oncologic
Details of Hepatitis C Ex-Gratia
Payment Scheme Announced
FDA Launches Consumer Campaign
on Safe Use of OTC Pain Products
Wisconsin Senate Approves
Tax Deduction for Organ Donors
Scotland: Fury at “abysmal”
level of payouts in blood scandal
January 20th, 2004
Prometheus Laboratories
Introduces FIBROSpect(SM) II
A New Improved Non-Invasive Test for the Detection of
Liver Fibrosis
SAN DIEGO, Calif., Jan. 20 /PRNewswire/
-- Prometheus Laboratories Inc., a specialty pharmaceutical
company, announced today the introduction of FIBROSpect II,
a unique non-invasive diagnostic panel to aid in the detection
of liver fibrosis in patients with chronic hepatitis C. This
simple blood test helps physicians differentiate the presence
of no/mild from significant liver fibrosis without the pain,
anxiety and risk associated with liver biopsy.
"In chronic hepatitis C infection,
liver biopsy has been the favored approach to evaluate the
extent of liver fibrosis and help guide treatment decisions;
however, it is expensive, associated with possible complications,
and limited by sampling error and observer variability,"
stated Dr. F. Fred Poordad, Associate Director, Hepatology
and Liver Transplant at Cedars Sinai Medical Center. "Non-invasive
methods to aid in assessing liver disease severity, such as
FIBROSpect II, provide additional diagnostic options."
FIBROSpect II, an enhanced version of the
original FIBROSpect test, eliminates indeterminate test results
that were occasionally reported with the first generation
test, and improves the ability to accurately differentiate
patients with and without significant liver fibrosis. FIBROSpect
II is based on three extracellular matrix remodeling proteins
utilizing a new algorithm and unique index, thereby providing
physicians with even more clinically useful information.
According to the most recent estimates
by the Centers for Disease Control and Prevention, 3.9 million
people are currently infected with hepatitis C in the U.S.,
with 2.7 million being chronically infected. Worldwide, over
170 million are infected. Chronic hepatitis C varies in its
cause and outcome. At one end of the spectrum are patients
who have no sign of liver disease and for whom the overall
prognosis may be good. At the other end of the spectrum are
patients with chronic hepatitis C and advanced fibrosis that
may ultimately develop end-stage liver disease. The major
consequence of liver disease is the progression to fibrosis
and cirrhosis, which can lead to liver cancer or the need
for a liver transplant. Therefore, early and accurate diagnoses
and staging are critical for proper patient management.
Prometheus Laboratories Inc. is a specialty
pharmaceutical company committed to developing new ways to
help physicians individualize patient care. The Company focuses
on the treatment, diagnosis and detection of gastrointestinal,
autoimmune and inflammatory diseases and disorders. The Company's
strategy includes the marketing and delivery of pharmaceutical
products complemented by its proprietary, high-value diagnostic
testing services. By integrating these therapeutic, diagnostic
and treatment monitoring services, Prometheus addresses the
full continuum of care, thereby providing physicians with
a comprehensive solution to treat chronic diseases. Prometheus'
corporate offices are located in San Diego, California. Additional
information about Prometheus Laboratories Inc. can be found
at www.prometheuslabs.com
CONTACT: Beth Kriegel, Senior Director,
Corporate Communications and
Investor Relations of Prometheus Laboratories Inc., +1-858-410-2516
Web site: http://www.prometheuslabs.com/
Back to top
Schering-Plough
Announces Availability of Rebetol Oral Solution for Use in
Treating Pediatric Hepatitis C
First approved therapy for children with chronic hepatitis
C fills unmet medical need
KENILWORTH, N.J., Jan. 20, 2004 —
Schering-Plough Corporation (NYSE: SGP), the leading innovator
of interferon-based therapies for chronic hepatitis C, today
announced the launch of REBETOL (ribavirin, USP) Oral Solution
for use in combination with INTRON A (interferon alfa-2b,
recombinant) Injection for treating pediatric chronic hepatitis
C. Previously, there was no therapy approved for children
with hepatitis C. An estimated four million people in the
United States are infected with the hepatitis C virus, and
approximately 160,000 of these are children.
“Now for the first time, children
with hepatitis C have a treatment option that has been proven
effective and, importantly, the doses may be tailored to a
child’s individual body weight and size,” said
Maureen Jonas, M.D., associate professor of pediatrics at
Harvard Medical School and associate in gastroenterology at
Children’s Hospital Boston. “Combination therapy
is now available for children as young as three years of age,
with the REBETOL dosing made easier by the availability of
the oral solution. This is an important step forward in treating
pediatric hepatitis C, a disease that can cause a myriad of
medical complications and eventually lead to serious liver
damage.”
In a clinical study of previously untreated pediatric patients,
INTRON A and REBETOL combination therapy achieved a sustained
virologic response (SVR) in 46 percent of patients overall,
with an SVR rate of 36 percent in genotype 1 patients and
81 percent in genotype 2 or 3 patients.
In the pediatric population, the combination
of INTRON A and REBETOL is indicated for the treatment of
chronic hepatitis C in patients three years of age and older
with compensated liver disease previously untreated with alpha
interferon. For these patients, individualized combination
therapy is recommended, with REBETOL dosed according to patient
body weight (15 mg/kg daily in divided a.m. and p.m. doses)
and INTRON A dosed according to patient size measured in body
surface area (3 MIU/m2 three times weekly). The recommended
duration of therapy is 24 weeks for pediatric patients with
genotype 2 or 3 virus. The recommended duration of therapy
for pediatric patients with genotype 1 virus is 48 weeks.
Treatment discontinuation should be considered for any patient
who has not achieved a virologic response after 24 weeks of
treatment.
The New Drug Application (NDA) for REBETOL
for pediatric use was reviewed by the U.S. Food and Drug Administration
(FDA) on a priority basis. Priority review status is granted
to drugs that, if approved, would address unmet medical needs
and represent significant advances over existing treatments.
Schering-Plough also noted that FDA has granted orphan-drug
designation to REBETOL for the treatment of chronic hepatitis
C in pediatric patients.
REBETOL Oral Solution represents a new
formulation of ribavirin, USP, and was developed specifically
to meet the needs of pediatric patients. It has a pleasant
bubble gum flavor. REBETOL Capsules also are now approved
for use in combination therapy with INTRON A for the treatment
of chronic hepatitis C in pediatric patients. REBETOL Capsules
were previously approved for use in combination therapy with
INTRON A for the treatment of chronic hepatitis C in patients
18 years of age and older with compensated liver disease previously
untreated with alpha interferon or who have relapsed following
alpha interferon therapy. REBETOL Capsules also are indicated
in combination with PEG-INTRON(peginterferon alfa-2b) Powder
for Injection for the treatment of chronic hepatitis C in
patients with compensated liver disease who have not been
previously treated with interferon and are at least 18 years
of age.
Since the introduction of PEG-INTRON and
REBETOL combination therapy in 2001, more than 300,000 hepatitis
C patients worldwide have received this treatment, including
more than 200,000 U.S. patients.
Approximately 70 percent of patients infected
with the hepatitis C virus (HCV) go on to develop chronic
liver disease, according to the Centers for Disease Control
and Prevention (CDC). Hepatitis C infection contributes to
the deaths of an estimated 8,000 to 10,000 Americans each
year and this toll is expected to triple by the year 2010,
according to the CDC. The CDC has reported that HCV-associated
end-stage liver disease is the most frequent indication for
liver transplantation among adults. It is predicted that direct
U.S. medical costs to treat HCV-related disease will exceed
$13 billion for the years 2010 through 2019, according to
a study published in the American Journal of Public Health.
Commitment to Hepatitis C Patients
Schering-Plough is committed to supporting hepatitis C patients
with education and service programs as well as to help locate
financial assistance for patients in need. The company’s
programs for patients in the United States are among the most
comprehensive in the industry, providing support and guidance
to patients, and ensuring that all eligible patients have
access to the company’s hepatitis C products.
Schering-Plough’s Be In Charge hepatitis
C patient-support program has enrolled approximately 95,000
U.S. patients since its inception in 1997. This U.S. program
is designed to support patients treated with Schering-Plough
hepatitis C products through the use of educational materials
and telephone contact with personal nurse counselors skilled
in the management of hepatitis C.
The company’s Commitment to Care
program is designed to ensure that eligible U.S. patients
have access to Schering-Plough’s hepatitis products,
either by assisting patients in obtaining the reimbursement
or assistance for which they qualify, or by providing products
free of charge to eligible patients. The market value of treatment
provided to hepatitis C patients through this program exceeded
$170 million in 2003.
REBETOL is an oral formulation of ribavirin,
a synthetic nucleoside analog. Schering-Plough has worldwide
rights to market oral ribavirin for hepatitis C through a
licensing agreement with Valeant Pharmaceuticals International
(NYSE: VRX), formally ICN Pharmaceuticals, of Costa Mesa,
Calif.
PEG-INTRON is a longer-acting form of INTRON
A that uses proprietary PEG technology developed by Enzon,
Inc. (NASDAQ: ENZN) of Bridgewater, N.J. Schering-Plough holds
an exclusive worldwide license to PEG-INTRON.
INTRON A is a recombinant version of naturally
occurring alpha interferon, which has been shown to exert
both antiviral and immunomodulatory effects. Schering-Plough
markets INTRON A for 16 major antiviral and anticancer indications
worldwide.
WARNING
•REBETOL monotherapy is not effective for the
treatment of chronic hepatitis C virus infection and should
not be used alone for this indication. (See WARNINGS.)
•The primary toxicity of ribavirin is hemolytic
anemia. The anemia associated with REBETOL therapy may result
in worsening of cardiac disease that has lead to fatal and
nonfatal myocardial infarctions. Patients with a history of
significant or unstable cardiac disease should not be treated
with REBETOL. (See WARNINGS, ADVERSE REACTIONS, and DOSAGE
AND ADMINISTRATION.)
•Significant teratogenic and/or embryocidal effects
have been demonstrated in all animal species exposed to ribavirin.
In addition, ribavirin has a multiple-dose half-life of 12
days, and so it may persist in nonplasma compartments for
as long as 6 months. Therefore, REBETOL therapy is contraindicated
in women who are pregnant and in the male partners of women
who are pregnant. Extreme care must be taken to avoid pregnancy
during therapy and for 6 months after completion of treatment
in both female patients and in female partners of male patients
who are taking REBETOL therapy. At least two reliable forms
of effective contraception must be utilized during treatment
and during the 6-month post-treatment follow-up period. (See
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS-Information for Patients
and Pregnancy Category X.)
• Alpha interferons, including PEG-INTRON and
INTRON A, may cause or aggravate fatal or life-threatening
neuropsychiatric, autoimmune, ischemic and infectious disorders.
Patients should be monitored closely with periodic clinical
and laboratory evaluations. Patients with persistently severe
or worsening signs or symptoms of these conditions should
be withdrawn from therapy. In many but not all cases these
disorders resolve after stopping therapy with PEG-INTRON or
INTRON A. (See WARNINGS, ADVERSE REACTIONS.)
PEG-INTRON
There are no new adverse events specific to PEG-INTRON as
compared to INTRON A, however, the incidence of some (e.g.,
injection site reactions, fever, rigors, nausea) were higher.
The most common adverse events associated with PEG-INTRON
were “flu-like” symptoms, occurring in approximately
50% of patients, which may decrease in severity as treatment
continues. Application site disorders were common (47%), but
all were mild (44%) or moderate (4%) and no patient discontinued,
and included injection site inflammation and reaction (i.e.,
bruise, itchiness, irritation). Injection site pain was reported
in 2% of patients receiving PEG-INTRON. Alopecia (thinning
of the hair) is also often associated with alpha interferons
including PEG-INTRON.
Psychiatric adverse events, which include
insomnia, were common (57%) with PEG-INTRON, but similar to
INTRON A (58%). Depression was most common at 29%. Suicidal
behavior including ideation, suicidal attempts, and completed
suicides occurred in 1% of patients during or shortly after
completing treatment with PEG-INTRON. PEG-INTRON is contraindicated
in patients with autoimmune hepatitis and decompensated liver
disease.
The following serious or clinically significant
adverse events have been reported at a frequency <1% with
PEG-INTRON or interferon alpha: Severe decreases in neutrophil
or platelet counts, hypothyroidism, hyperglycemia, hypotension,
arrhythmia, ulcerative and hemorrhagic colitis, development
or exacerbation of autoimmune disorders including thyroiditis,
RA, systemic lupus erythematosus, psoriasis, pulmonary disorders
(dyspnea, pulmonary infiltrates, pneumonitis and pneumonia,
some resulting in patient deaths), urticaria, angioedema,
bronchoconstriction, anaphylaxis, retinal hemorrhages and
cotton wool spots.
Renal failure patients should be closely
monitored for signs and symptoms of interferon toxicity and
PEG-INTRON should be used with caution in patients with creatinine
clearance <50 mL/min. Patients on PEG-INTRON therapy should have hematology
and blood chemistry testing before the start of treatment
and then periodically thereafter.
INTRON A
All patients receiving INTRON A therapy experienced mild-to-moderate
side effects. Some patients experienced more severe side effects,
including neutropenia, fatigue, myalgia, headache, fever,
chills and increased SGOT. Other frequently occurring side
effects were nausea, vomiting, depression, alopecia, diarrhea
and thrombocytopenia. DEPRESSION AND SUICIDAL BEHAVIOR, INCLUDING
SUICIDAL IDEATION, SUICIDAL ATTEMPTS, AND COMPLETED SUICIDES,
HAVE BEEN REPORTED IN ASSOCIATION WITH TREATMENT WITH ALFA
INTERFERONS, INCLUDING INTRON A THERAPY.
DISCLOSURE NOTICE: The information in this
press release includes certain “forward-looking”
statements concerning REBETOL Oral Solution and Capsules in
the United States, the market for drugs to treat hepatitis
C and Schering-Plough’s products. Forward-looking statements
are subject to risks and uncertainties, which may cause actual
results to differ materially. These risks and uncertainties
include product availability, current and future branded,
generic and OTC competition, market acceptance of new products,
timing of trade buying, and patent positions. For further
details and a discussion of these and other risks and uncertainties,
see the company’s Securities and Exchange Commission
filings, including the third quarter 2003 Form 10-Q.
Schering-Plough is a research-based company
engaged in the discovery, development, manufacturing and marketing
of pharmaceutical products worldwide.
Back to top
January 21st, 2004
Officers
Being Monitored After Being Bitten by Inmates
OKLAHOMA CITY (AP) -- Officials are monitoring
two Oklahoma County detention officers after they were bitten
by an inmate who tested positive for hepatitis C.
The guards, whose names have not been released,
were bitten by a female inmate about 3 p.m. Sunday.
The officers returned to work hours later,
Capt. Kelly Marshall said.
The virus is spread by contact with the
blood of an infected person.
It takes three or more months for symptoms
to appear and some people with the disease never develop symptoms.
"We will continue to monitor them
for at least a year and longer if the physicians tell us to,"
Marshall said.
The 25-year-old inmate was arrested earlier
in the day on complaints of driving without a license and
having no insurance verification.
After being denied usage of an office phone,
the inmate, whose name has not been released, told an officer
asked to be returned to her cell.
"She raised her hand to assault the
officer and then threw herself to the ground to resist being
placed in her cell," Marshall said.
The inmate bit officers and said she had
AIDS. The inmate did not test positive for AIDS, but she did
have hepatitis C, a disease that can affect the liver.
An inmate has assaulted an officer with
a bodily fluid at least 10 times in past year, Marshall said.
Bites are less common and so far an officer
has never developed a disease after an attack.
The inmate could face assault and battery
charges.
Information from: The Daily Oklahoman
Back to top
Colorado
Organ and Tissue Donor Registry Sees Unprecedented Growth
Public Education Efforts and Increased Awareness Credited
for the Most Significant Increase of Willing Donors to Date
DENVER, Jan. 21, 2004 /PRNewswire/ -- Less than three years
after the State legislature's creation of the Colorado Organ
and Tissue Donor Registry, an unprecedented number of Coloradans
have signed up through Driver License Offices (DLOs) statewide
to be listed on the Donor Registry as potential organ and
tissue donors.
The Donor Registry is a confidential database
of individuals throughout the state who have documented their
decision to be organ and tissue donors at the time of death.
Statistics on the success of the Donor
Registry are from 2003 data reported by Donor Awareness Council,
a non-profit coalition formed to increase organ and tissue
donation through education and awareness in Colorado and Wyoming.
The organization, which oversees the public awareness program
run at DLOs, reports that in 2003 more than 55 percent of
all Coloradans who applied for or renewed their driver licenses
or who got identification cards at DLOs last year signed up
for the Donor Registry. In 2002, 43.9 percent of Colorado's
population signed up through DLOs. This year's figures mark
an unparalleled 11.1 percent increase over 2002 and a 20.4
percent increase since the Donor Registry was created in 2000.
"These numbers are the highest we've
seen since the creation of the Donor Registry. They mark a
real milestone that we believe is the result of a cumulative
impact of seven years of public awareness efforts," explained
Marlene Murphy, executive director of Donor Awareness Council.
"The positive messages put forth by all of our coalition
partners as well as through our public outreach efforts, including
the driver license office program, have helped more Coloradans
than ever understand the importance of donation and to take
action."
As one example of that success, the Rocky
Mountain Lions Eye Bank, which facilitates the recovery, evaluation
and placement of donated eye tissues and is a Donor Awareness
Council coalition partner, reports that 52 percent of all
eye tissue donors in Colorado last year came from the Donor
Registry, which equated to 1,114 sight-restorative transplants.
The remainder of the eye tissue transplants conducted last
year came from decisions to donate made by families at the
time of family members' deaths.
Underscoring the importance of the Donor
Registry, Edmund Jacobs, the Eye Bank's Executive Director,
said the Registry is a source of solace for families. "By
signing up for the Donor Registry in life, these people were
able to give sight to others in death.
Many families tell us they find comfort
in knowing that their loved ones not only wanted to be a donor,
but that his or her wishes could now be followed, rather than
second guessed or assumed," Jacobs said.
Prior to the Donor Registry's creation,
organ and tissue donation information was located on the driver
license document, with no other way to verify a person's decision
at the time of death. This left many families with the responsibility
to make the decision for their loved ones. The Donor Registry
now allows organ and tissue recovery agencies, including the
Rocky Mountain Lions Eye Bank, to verify the donor's decision.
This spares the next-of-kin from having to make the decision
to donate at a difficult time.
In the legislation that created the Donor
Registry, potential donors are also given the ability to sign
up at public events and over the Internet, as well as through
driver license offices. It also allowed those under 18 years
of age to be included in the Donor Registry, with the consent
of a parent or legal guardian.
Equally as important, earlier legislation
provided the opportunity for driver license and identification
card applicants to make a financial contribution to the Colorado
Organ and Tissue Donation Awareness Fund. The monies contributed
to the Fund are allocated to the Donor Awareness Council for
donor awareness activities throughout Colorado. The Donation
Awareness Fund also helped to create the Donor Registry.
"While, again, we are very encouraged
by the number of people saying yes to help save lives through
organ tissue donation and to those who have contributed to
the Donation Awareness Fund, there are still major challenges
that remain," Murphy explained. "With more than
1,400 people in Colorado awaiting life-saving organ transplants
and nearly 83,000 people waiting across the country, it remains
critical that we continue to have the means to reach the 45
percent of Coloradans who have yet to say yes."
More information on organ and tissue donation
as well as the Colorado Donor Registry can be found at www.ColoradoDonorRegistry.org.
About Donor Awareness Council
Donor Awareness Council is a non-profit coalition formed in
1989 to increase organ and tissue donation though public education
and awareness in communities across Colorado and Wyoming.
Its vision is to help the public understand the benefits of
organ and tissue donation so that every potential transplant
recipient has the opportunity for an increased quality of
life.
Donor Awareness Council Coalition Partners
include AlloSource; American Liver Foundation; American Transplant
Association, Rocky Mountain Chapter; Black Transplants Action
Committee; Centura Health -- Porter Transplant Service; ClinImmune
Labs; Donor Alliance; Laboratories at Bonfils/Bonfils Blood
Center; National Kidney Foundation of Colorado, Idaho, Montana
& Wyoming; Presbyterian St. Luke's Medical Center; Rocky
Mountain Lions Eye Bank; The Children's Hospital; University
of Colorado Hospital.
Please visit www.donor-awareness.org
or call (303) 388-8605 or (888) 388-8605 to request a brochure
or to learn how to contribute to the Donation Awareness Fund.
For more information, please contact Caitlin
Jenney of GBSM,
+1-303-825-3380, caitlinjenney@gbsm.com,
for Donor Awareness Council.
SOURCE: Donor Awareness
Council
Back to top
InterMune
Announces Results of Exploratory Phase II Study Of Interferon
Gamma-1b in Advanced Liver Fibrosis
BRISBANE, Calif., Jan 21, 2004 /PRNewswire-FirstCall
via COMTEX/ -- InterMune, Inc. (Nasdaq: ITMN) today announced
results of an exploratory Phase II clinical trial evaluating
interferon gamma-1b for the potential treatment of advanced
liver fibrosis, or cirrhosis, caused by hepatitis C virus
(HCV) in patients who have failed standard antiviral therapy.
The objectives of the study were to evaluate safety and the
ability of interferon gamma-1b treatment to reverse fibrosis
in chronic hepatitis C patients with advanced liver disease
when administered for 48 weeks. The primary endpoint of the
study, reversal of liver fibrosis as determined by the Ishak
histology scoring system, was not met. Interferon gamma-1b
was generally well tolerated and side effects were consistent
with those seen in previous experiences.
"We have learned from this study that
interferon gamma-1b is generally well tolerated in this patient
population," said James Pennington, M.D., Executive Vice
President of Medical and Scientific Affairs at InterMune.
"We believe that earlier intervention in milder patients
over a longer period of time may be necessary to demonstrate
efficacy."
About interferon gamma-1b (Actimmune(R))
Interferon gamma is a naturally occurring protein that stimulates
the immune system. InterMune markets Actimmune for the treatment
of two life-threatening congenital diseases: chronic granulomatous
disease and severe, malignant osteopetrosis. Presently, InterMune
is conducting a Phase III study of interferon gamma-1b in
idiopathic pulmonary fibrosis (IPF), and a Phase III study
of interferon gamma-1b in ovarian cancer. The most commonly
observed side effects are flu-like symptoms, including fever,
headache and chills. Physicians and patients can obtain additional
prescribing information regarding Actimmune, including the
product's safety profile, by visiting www.actimmune.com.
About InterMune
InterMune is a biopharmaceutical company focused on the applied
research, development and marketing of life-saving therapies
for pulmonary and hepatic diseases. For additional information
about InterMune, please visit www.intermune.com.
SOURCE: InterMune,
Inc.
For Investors, Myesha Edwards of InterMune,
Inc.415-466-2242, or ir@intermune.com
For Media, Ian McConnell of WeissCom Partners, Inc., +1-415-362-5018,
or ian@weisscom.net,
for InterMune, Inc.
http://www.actimmune.com
SourceURL: http://www.gastrohep.com/news
/news.asp?id=2493
Back to top
Weight Gain
After Transjugular Intrahepatic Portosystemic Shunt
www.gastrohep.com
Increased body cell and muscle mass contributes
to the weight gain after TIPS in malnourished patients with
cirrhosis and hypermetabolism, find researchers in the February
issue of the Journal of Hepatology.
Weight gain has been repeatedly observed in cirrhotic patients
following portosystemic shunting.
In this study, researchers from Germany
examined the changes in body composition and energy metabolism
associated with this procedure.
The team prospectively evaluated 21 patients
before and 6 and 12 months after transjugular intrahepatic
portosystemic shunt (TIPS).
They assessed patients' body cell mass
using 2 separate methods:
• Total body potassium counting (BCMTBP).
• Bioelectric impedance analysis (BCMBIA).
They also assessed muscle mass, resting
energy expenditure, and nutritional intake.
The researchers determined that the TIPS
patients were hypermetabolic and their body cell mass was
lower.
Following TIPS body cell mass (BCMBIA)
increased to 23.5 and 25.7 kg at 6 and 12 months, respectively.
This increase was confirmed by total potassium counting (BCMTBP).
The researchers found that hypermetabolism
persisted throughout the study period.
They also determined that energy intake
increased by 26% and protein intake by 33%.
Dr Mathias Plauth's team concluded, "An
increase of prognostically relevant variables body cell and
muscle mass contributes to the weight gain after TIPS in malnourished
patients with cirrhosis and hypermetabolism".
Source: J Hepatol
2004; 40(2): 228-33
Back to top
Occult
Hepatitis B Virus Infection Still Oncologic
NEW YORK (Reuters Health) Jan 22 - The
findings from a new study suggest that infection with hepatitis
B virus (HBV) promotes oncogenesis even in the absence of
circulating surface antigen.
Known as occult HBV infection, this type
of infection occurs when HBV is detectable in liver tissues
but not in the blood. Whether occult infection, like standard
infection, is associated with hepatocellular carcinoma (HCC)
has been unclear.
To investigate, Dr. Teresa Pollicino, from
the University of Messina in Italy, and colleagues tested
for HBV in liver tissue obtained from 107 patients with HCC
and 192 patients with chronic liver disease. All of the patients
tested negative for hepatitis B surface antigen.
The researchers' findings are reported
in the January issue of Gastroenterology.
Tissue HBV DNA was detected in 63.5% of
HCC patients compared with just 32.8% of control patients
(p < 0.0001). Moreover, the link between tissue HBV and
cancer held true after accounting for age, sex, and concomitant
hepatitis C virus infection.
The authors found that patients with occult
infection harbored both integrated viral DNA and covalently
closed circular HBV genomes. In addition, the presence of
free genomes was tied to persistent viral transcription and
replication.
"Our study definitively shows that
HBV also maintains its oncogenic role in the case of occult
infection," the researchers state. Therefore, surface
antigen-negative patients with progressive liver disease should
probably be tested for tissue HBV to assess their risk of
HCC.
In a related editorial, Dr. Jorge A. Marrero
and Dr. Anna S. F. Lok, from the University of Michigan in
Ann Arbor, comment that "it is premature to advocate
testing all hepatitis B surface antigen-negative patients
with HCC for occult HBV infection." Further studies are
also needed, they add, to determine the role occult infection
plays with HCC: innocent bystander, cofactor, or culprit.
Source: Gastroenterology
2004;126:102-110, 347-350
Back to top
January 23rd, 2004
Details of
Hepatitis C Ex-Gratia Payment Scheme Announced
London, GNN
DEPARTMENT OF HEALTH News Release (2004/0025) issued by the
Government News Network on 23 January 2004
Health Secretary John Reid today announced
a scheme by which, people infected with Hepatitis C from NHS
blood or blood products will be eligible to receive ex-gratia
payments from the Department of Health.
Every person in the UK who was alive on
the 29 August 2003 and whose Hepatitis C infection is found
to be attributable to NHS treatment with blood or blood products
before September 1991 will be eligible for the payments.
The ex-gratia payment scheme means that:
• people infected with Hepatitis C will receive
initial lump sum payments of £20,000.
• those developing more advanced stages of the
illness - such as cirrhosis or liver cancer - will get a further
£25,000; and
• people who contracted Hepatitis C through someone
infected with the disease will also qualify for payment
Mr Reid said:
“I'm pleased to be able to announce the details of this
scheme today.”
“I felt it was important that English
Hepatitis C patients should receive these payments on compassionate
grounds. It's clear that providing assistance is the right
thing to do.”
“I believe that these are fair and
reasonable payments and I hope that they will help alleviate
some of the problems people who have been affected in this
way are experiencing. I'm also glad that people who receive
awards from the scheme won't have the worry of losing their
social security benefits as a result.”
In addition to people currently infected
with Hepatitis C the scheme will also include people who have
cleared the virus as a result of treatment. Those infected
as a result of the virus being transmitted from someone who
was infected from blood or blood products will also be eligible
to receive payment as will people who were infected with HIV
as well as Hepatitis C.
The Department is currently setting up
the independent body that will administer the scheme and arranging
for the necessary benefit legislation to be amended. It is
hoped that the scheme will start operating in April this year.
Payments to eligible claimants will follow soon after that.
The Health Secretary said:
"We have ensured throughout our negotiations that the
scheme would be easily accessible for eligible patients. It's
important that people making a claim are not going to be bogged
down with bureaucracy.
"We are pressing forward with the
essential work that remains to be done in finalising the scheme,
including how the application process will work for awards.
We will be working with organisations such as the Haemophilia
Society and Hepatitis C Trust on this to help ensure the procedures
are as user friendly as possible."
A publicity campaign is being planned with
the relevant organisations to ensure that eligible claimants
know how to make an application to the scheme.
Source: DEPARTMENT
OF HEALTH
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FDA Launches
Consumer Campaign on Safe Use of OTC Pain Products
ROCKVILLE, Md., Jan. 22, 2004 - The Food and Drug Administration
(FDA) today launched a national education campaign to provide
advice on the safe use of over-the-counter (OTC) pain relief
products.
"Pain relievers and fever reducers
are safe drugs when used as directed, but they can cause serious
problems when used by people with certain conditions or those
who are taking specific medicines," said FDA Commissioner
Mark B. McClellan M.D., Ph.D. "We want to remind consumers
who take these products that it's important to follow current
dosing and label directions carefully."
FDA's nationwide campaign focuses on the
OTC pain and fever reducers that contain acetaminophen and
non-steroidal anti-inflammatory drugs (NSAIDs), which include
products such as aspirin, ibuprofen, naproxen sodium and ketoprofen.
"'Read labels carefully, be sure you
are getting the proper dose, and check with your doctor or
pharmacist to be sure that you can use these drugs safely,"
said Dr. McClellan.
Many OTC medicines sold for different uses
have the same active ingredient. For example, a cold-and-cough
remedy may have the same active ingredient as a headache remedy
or a prescription pain-reliever. To minimize the risks of
an accidental overdose, consumers should avoid taking multiple
medications that contain the same active ingredient at the
same time.
Acetaminophen is an active ingredient found
in more than 600 OTC and prescription medicines, such as pain
relievers, cough suppressants and cold medications. It is
safe and effective when used correctly, but taking too much
can lead to liver damage, and even death. The risk for liver
damage may be increased in consumers who drink three or more
alcoholic beverages per day while using acetaminophen-containing
medicines.
NSAIDs are common pain relievers that are
also used to relieve fever and minor aches and pains. Examples
of NSAIDs are aspirin, ibuprofen, naproxen sodium, and ketoprofen.
These products can cause stomach bleeding with an increased
risk in consumers who are over 60, are taking prescription
blood thinners, are taking steroids or have a history of stomach
bleeding. NSAIDS may also increase the risk of reversible
kidney problems in consumers with preexisting kidney disease,
or who are taking a diuretic (water pill).
The FDA's consumer educational campaign
will include: 1) an OTC pain reliever brochure to be distributed
in pharmacies, and by health care providers, 2) a "matte
release" newspaper article to be distributed to 10,000
community papers across the country, 3) a reprint of "Use
Caution With Pain Relievers", an FDA Consumer magazine
article that will be distributed at national healthcare conferences
and available for reprinting in health related publications
and 4) two print public service ads that will be sent to approximately
100 major magazines. All of these materials are available
on the web at http://www.fda.gov/cder/drug/
analgesics/default.htm.
The campaign will provide advice on how
to avoid inadvertently taking more than the recommended doses
of these medicines and outline underlying health conditions
that increase risk.
In September 2002, FDA's Non-Prescription
Drug Advisory Committee recommended changes to labeling of
certain OTC drug products, including acetaminophen and NSAIDS.
They advised that these changes are needed to better inform
consumers about the ingredients in these products and possible
side effects caused by improper use. In addition to this new
consumer outreach effort, FDA will consider changing the labeling
of these products to further bolster their safe use. FDA is
reviewing various changes to labeling for these ingredients
that better reflect the latest scientific knowledge about
OTC oral pain relievers.
The FDA recommends that consumers talk
with healthcare professionals or pharmacists if they have
questions about using an OTC medicine and especially before
using them in combination with dietary supplements or OTC
or prescription medicines. To learn more, call 1-888-INFO-FDA
or visit www.fda.gov/cder.
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
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Wisconsin
Senate Approves Tax Deduction for Organ Donors
JO NAPOLITANO NY Times
CHICAGO, Jan. 22 - The Wisconsin State Senate passed a bill
on Thursday calling for a state income tax deduction of up
to $10,000 to cover expenses for residents who donate their
organs. Supporters say it is the most ambitious move by a
state government to increase transplants.
The bill, which was overwhelmingly approved
by the State Assembly in November, passed in the Senate by
a vote of 28 to 2 and will now go to Gov. James E. Doyle,
a Democrat, who has said he will sign it into law.
"I'm very supportive of it,"
Mr. Doyle said. "This is a big issue in Wisconsin."
The law will allow donors to deduct from
their taxable income the costs they incur from donating all
or part of a liver, pancreas, kidney, intestine, lung or bone
marrow. Eligible expenses include travel, lodging and lost
wages, and the maximum deduction is $10,000. The law is expected
to cost the state about $115,000 annually, the bill's sponsors
say.
Critics of the legislation question whether
such a tax credit would violate the 20-year-old National Organ
Transplant Act. The federal law bans the purchase or sale
of human organs, an industry that spawned organ brokers overseas
but that is a crime in the United States punishable by a $50,000
fine and a five-year prison term.
"When you get as high as $10,000 you
start to wonder what that means to people and if there is
some coercion that goes on with that," said Howard M.
Nathan, president and chief executive of the Gift of Life
Donor Program, a nonprofit agency in Philadelphia.
But State Representative Steve Wieckert,
a Republican from Appleton who sponsored the bill, said it
was not intended to offer cash for human organs. Instead,
the tax credit would help remove an obstacle that prevents
people from donating, he said.
"We want to be very careful that we
are not getting into the business of selling organs but to
encourage organ donation," Mr. Wieckert said. "No
one, rich or poor, would receive any additional money for
donating. All they would do is lose less money."
Mr. Wieckert said that the federal ban
on payment for organs excludes costs associated with travel,
lodging and lost wages, so the law would be within federal
guidelines.
One Wisconsin organ donor says he knows
all too well the need for financial reimbursement for the
people who undergo such procedures. The man, Marty Monroe,
donated a kidney to his son, Cody, who was 5 in December 2001
when he suffered kidney failure. Mr. Monroe, who is married
with three children, was out of work for three months and
lost $6,000 in wages after the surgery.
"These days, if you miss a payment
on your bills, they call the collection agency and they can
repossess your house," said Mr. Monroe, a truck driver
who lobbied for passage of the bill. "I think the law
is fine. They're not giving money for organs, but helping
people survive after giving the gift of life."
State Representative Bob Ziegelbauer, a Democrat from Manitowoc,
northeast of Madison, was the only Assembly member to vote
against the bill, saying it would needlessly complicate the
tax code for a marginal deduction at a time when his state
faces a fiscal crisis.
"Why should the government be in the
business of handing out rewards to people when they do good
things?" he said. "I think we need to keep the tax
code simple and understandable."
Wisconsin is not the first state to try
to create incentives to increase organ donations. Indiana
is considering nearly identical legislation.
The Kansas Legislature considered approving
a tax break for blood and organ donation in 2000, but the
bill stalled in committee after the state's attorney general
wrote in an opinion that the proposal was prohibited by federal
law.
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January 23rd, 2004
Scotland:
Fury at “abysmal” level of payouts in blood scandal
James Meikle, health correspondent
Saturday January 24, 2004
The Guardian
Haemophiliacs and others infected with
hepatitis C through contaminated blood products expressed
outrage last night at the level of government ex gratia payments
and the exclusion of widows and families from help.
Payments of up to £45,000 were said
to be barely a tenth of some awards in Ireland. Well over
200 Britons have already died from liver cancer or other illnesses
caused by the hepatitis infection.
About 7,000 people may benefit from payouts
later this year - many of them haemophiliacs infected by clotting
factors before a satisfactory test for detecting the virus
was introduced in 1991. The government accepts no responsibility
for the infections and wants to settle the long-running dispute
on compassionate grounds.
Many clotting factors were imported from
America, but some people were infected from transfusions carried
out in this country before 1991.
Others who can prove they contracted hepatitis
C through close contact - such as sharing toothbrushes or
having sex - with a person infected in this way will also
receive payments, which in many cases will not exceed £20,000.
But widows and dependants will not receive any aid otherwise.
One widow, Harriet Bullock, said: “This
is unbelievable. If I was a farmer and my husband was a sheep,
I would have been compensated. I am so angry.”
Ken Bullock died five years ago, leaving
three children and three grandchildren. He had continued to
work as a civil engineer despite failing health.
"The disease left him exhausted almost all the time,"
said his widow. “He couldn't play with the children
or go for walks at the weekend.”
Other campaigners pointed out that some
carers had given up jobs or could not start them because they
were caring for sick patients. Haemophilia is a condition
that affects only men. Those with families did get higher
awards in the early 1990s when a similar scheme was announced
for those accidentally infected with HIV.
About 500 people are co-infected with the
two diseases.
Carol Grayson, a spokeswoman for Haemophilia
Action UK whose husband Peter is one of these, said: “This
is abysmal. It is a terrible illness and those women who gave
up a career to care for their husbands are being treated in
a disgusting manner.”
Karin Pappenheim, the Haemophilia Society's
chief executive, said the exclusion of bereaved families was
“a bitter blow to those who surely have suffered the
worst harm from this tragic treatment disaster”.
The payments, announced by John Reid,
the health secretary, amount to £20,000 per person plus
£25,000 for those living with advanced stages of the
disease. This falls short of the £50,000 recommended
by a Scottish inquiry and is far less than the average £140,000
suggested by the society, based on a scheme in Canada.
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