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Alan Franciscus
Editor-in-Chief
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In This Issue:
HIV and HCV Independently
Cause Psychomotor Slowing
Diabetes an "Important" Risk Factor
for Chronic Liver Disease and Liver Cancer
Rising Death Rates From Hepatitis C-Related Chronic
Liver Disease
XTLbio’s HepeX-B Receives Orphan Drug Designation
from the European Agency for the Evaluation of Medicinal Products
(EMEA)
Patients Take Fight Against Hepatitis C into
Their Own Hands
Study Shows Highest Sustained Response Rates
Ever Reported in Patients Infected with Hepatitis C
H3 Pharma Submits New Drug Application To FDA
For Sanvar IR
Body Pain May Hinder Depression Treatment: Study
Approved Injection Sites Create State 'Complicity'
in Drug Abuse: UN Agency
New York Times Profiles Head of New York-Based
Harm Reduction Coalition
New Onset Diabetes Mellitus After Liver Transplantation
Antibiotics After Endoscopic Therapy Prevent
Rebleeding
Ancient Virus May Help HIV Patients Live Longer
Medical Services International Inc. Intensifies
Hepatitis B Testing
FDA Launches New Easy-to-Use Drug Information
Web Site
Valeant Pharmaceuticals International (VRX)
Reports Published 24-Week Data Abstracts For Viramidine
Compensation for Mum Infected by Transfusion
February 25th, 2004
HIV
and HCV Independently Cause Psychomotor Slowing
By David Douglas
Source: Reuters Health
NEW YORK - Whether alone or in co-infection,
both HIV and hepatitis C virus (HCV) can cause central nervous
system (CNS) disturbances, according to researchers at Heinrich
Heine University in Dusseldorf, Germany.
As lead investigator Dr. Hans-Jurgen von
Giesen told Reuters Health, "not only HIV, but also HCV
seems to affect the CNS in otherwise healthy patients, so
that HIV/HCV co-infected patients have to be treated with
a special emphasis on the CNS."
Dr. von Giesen and colleagues came to this
conclusion following a study of 43 HIV-seropositive but HCV-seronegative
patients, 43 HIV/HCV co-infected patients and 44 HIV-negative
but HCV-positive patients.
Using neuropsychologic and electrophysiologic
motor tests, the researchers found that compared to controls,
those in all 3 groups showed significant pathological slowing
of most rapid alternating movements of the right hand. Significantly
prolonged contraction times were also seen in both hands.
In HIV/HCV co-infected patients simple
reaction times were also significantly prolonged.
Given these similar findings, the researchers
believe that there may be similar mechanisms at work in both
diseases.
They suggest that the pathology should
be further clarified by spectroscopic and molecular methods
and, as Dr. von Giesen pointed out, "the long-term consequences
of HCV infection of the brain have to be elucidated."
J Acquir Immune Defic Syndr 2004;35:131-137.
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Diabetes
an "Important" Risk Factor for Chronic Liver Disease
and Liver Cancer
By Megan Rauscher
Source: Reuters Health
NEW YORK - Men with diabetes have about
a two-fold greater risk of developing chronic non-alcoholic
liver disease (CNLD) and hepatocellular carcinoma (HCC) compared
with nondiabetic men, results of a large prospective cohort
study suggest.
"Our study provides evidence that
diabetes is an important risk factor for chronic liver disease
including HCC," Dr. Hashem B. El-Serag from the Houston
VA Medical Center in Texas told Reuters Health.
Using the computerized records of the Department
of Veterans Affairs, investigators reviewed the records of
all patients with a hospital discharge diagnosis of diabetes
between 1985 and 1990 (n=173,643). They matched each diabetic
patient to three nondiabetic patients (n=650,620) and tracked
them through 2000. Most of the subjects were men (98%), most
of the diabetic patients had type 2 diabetes mellitus (99.5%),
and none of them had a recorded history of liver disease prior
to entry.
According to a report in the February issue
of the journal Gastroenterology, the incidences of
CNLD and HCC were significantly higher in diabetic than in
the nondiabetic patients (p < 0.0001 for both).
Diabetes was associated with a hazard ratio
for CLND and HCC of 1.98 and 2.16, respectively. The increased
risk "seems to be independent of age, gender, ethnicity,
or comorbid illnesses, Dr. El-Serag told Reuters Health, and
is higher in patients with diabetes for 10 years of more.
Several previous studies have found a statistically
significant positive association between diabetes and HCC.
"However, it remained unclear until this study whether
diabetes preceded the development of significant chronic liver
disease and HCC as diabetes could be a result (rather than
a cause) of pre-existing severe liver disease," Dr. El-Serag
said.
This study, Dr. Adrian M. Di Bisceglie
from Saint Louis University School of Medicine points out
in an editorial, "provides evidence that long-standing
diabetes is followed by the development of liver disease and
HCC, suggesting a causative role for diabetes mellitus."
The current study supports the team's earlier
findings from the same cohort of patients in which diabetes
conferred a 1.44 relative risk of developing acute liver failure.
(See Reuters Health report July 12, 2002).
In light of the finding, Dr. El-Serag and
colleagues recommend regular testing of liver enzymes in diabetic
patients. "For patients with diabetes who receive oral
medications, there has been a concern about toxicity in the
liver - more reason to test liver enzymes early on and then
periodically thereafter," the researcher said in a statement.
Further studies are needed to examine the
association between diabetes and liver disease in women and
to clarify the mechanisms behind the link, the authors note.
Gastroenterology 2004;126:460-468,604-605.
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February 27th, 2004
Rising Death
Rates From Hepatitis C-Related Chronic Liver Disease
Source: Reuters Health Information 2004
NEW YORK - Though chronic liver disease
mortality declined slightly, the mortality rates for hepatitis
C-related chronic liver disease more than doubled during the
1990s, according to a report in the February issue of Hepatology.
Chronic liver disease (CLD) is the 10th
most frequent cause of death in the United States, the authors
explain, but the contribution of viral hepatitis to CLD-related
mortality has been elusive.
Dr. Sirenda Vong and Dr. Beth P. Bell from
Centers for Disease Control and Prevention (CDC), Atlanta,
Georgia used an expanded definition of CLD deaths that included
death certificates where CLD, viral hepatitis, or CLD-related
sequelae were reported to calculate overall age-specific and
age-adjusted mortality rates from 1990 through 1998.
The age-adjusted death rate for CLD declined
4.5% (from 12.1 to 11.6/100,000) between 1990 and 1998, the
authors report, though rates were stable from 1995 through
1998.
Between 1993 and 1998, hepatitis C-related
CLD deaths increased 220%, the report indicates, along with
a 45% increase in deaths from unspecified viral hepatitis.
Hepatitis B-related CLD deaths remained unchanged from 1990
through 1998.
During this period, deaths from alcohol-related
CLD fell by 10.5%, the researchers note, whereas death rates
from primary biliary cirrhosis increased by 12.8%.
Age-adjusted death rates in 1998 were highest among American
Indians/Alaska Natives (28.7/100,000), the results indicate,
followed by African Americans (12.9/100,000), whites (11.5/100,000),
and Asians/Pacific Islanders (4.1/100,000). Age-adjusted death
rates were more than 1.5 times higher among Hispanics than
among non-Hispanics.
"In contrast to reported trends,"
the investigators write, "the decline in CLD mortality
observed during previous decades and sustained through the
early 1990s did not continue after 1994, largely because of
increases in hepatitis C-related deaths."
"This analysis highlights large disparities
in CLD mortality, demonstrating the need for social and public
health interventions that target high-risk groups such as
American Indians/Alaska Natives and Hispanic Americans,"
the authors conclude. "Further studies are needed to
evaluate the validity of estimates of the mortality burden
from CLD generated from national mortality data and to characterize
better the causes of CLD deaths."
Hepatology 2004;39:476-483.
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March 1st, 2004
XTLbio’s
HepeX-B Receives Orphan Drug Designation from the European
Agency for the Evaluation of Medicinal Products (EMEA)
Rehovot, Israel, – XTL Biopharmaceuticals Ltd. (XTLbio)
reported today that the European Agency for the Evaluation
of Medicinal Products (EMEA) has granted its investigational
therapeutic product, HepeX-B™, Orphan Drug Designation
(see Notes to Editors) for prevention of hepatitis B infection
in liver transplant patients.
Hepatitis B is the most common form of
hepatitis and one of the world’s leading causes of death.
About 5% of chronic hepatitis B patients will develop end-stage
liver disease, a condition, which necessitates liver transplantation.
During the liver transplantation procedure the diseased liver
is removed and a healthy liver from a donor is transplanted.
Without proper treatment, the newly transplanted liver can
become re-infected by residual virus in the patient’s
serum, leading to rapid disease progression and graft failure
in many cases. The current market for prevention of hepatitis
B infection following liver transplant is estimated to be
worth $100 million.
HepeX-B is a combination of two fully human
monoclonal antibodies acting on the hepatitis B virus surface
antigen, which were selected based on their strong activity
against the virus in XTLbio's pre-clinical Trimera™
model. In a recently reported study, HepeX-B maintained serum
levels similar to or higher than the current first-line treatment
(polyclonal preparation of hepatitis B immunoglobulin), while
using 1,000 times less drug.
Dr. Martin Becker, XTLbio’s Chief
Executive Officer, commented: "The granting of Orphan
Drug Designation in Europe complements well our pre-marketing
efforts for HepeX-B, with a similar status having been granted
in the US last year. HepeX-B is progressing well through Phase
II trials and, as disclosed at our results last week, we are
in discussions with potential partners in order to take the
product through to registration."
Contacts:
XTLbio - Dr. Martin Becker, President and CEO, Tel: +972-8-930-4440
Financial Dynamics; David Yates, Sarah MacLeod, Tel: +44 (0)
20 7831 3113
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Patients
Take Fight Against Hepatitis C into Their Own Hands
Source: Associated Press
According to health officials, as many
as 23,000 Maine residents are infected with hepatitis C (HCV),
the most common blood-borne infection in the United States
and the number-one reason for liver transplants. Yet, resources
to fight the virus are scarce: Last year, Maine used $32,000
in federal block grants and $15,000 in private funds to provide
free HCV testing at 22 sites statewide. CDC provided around
$110,000 to fund the state's viral hepatitis coordinator.
In contrast, Maine last year allocated
$1.9 million in federal and state funds for HIV prevention
programs and about $350,000 for STD control and prevention.
To raise awareness about HCV, some patients
are taking matters into their own hands. "It's time for
someone to come out and for people to understand that over
4 million Americans are infected with this virus and it's
a big epidemic," said Norm Burnell, who thinks he was
exposed to HCV as a medic in the Vietnam War. Burnell has
created a Web site, www.hepatitiscnme.org,
to advocate for patients.
Joelle Leeks, 36, was shocked when she
was diagnosed with HCV in May. She eventually traced her transmission
to a blood transfusion after a 1987 car accident. Leeks and
members of her support group are beginning a grassroots HCV
education campaign aimed at the public and health care practitioners.
"The knowledge about hepatitis C has
expanded," said Geoff Beckett, assistant state epidemiologist.
"Nobody knew what to do about it early on, and that's
changed very dramatically in the last five or six years."
Source: AEGIS
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March 2nd, 2004
Study Shows
Highest Sustained Response Rates Ever Reported in Patients
Infected with Hepatitis C: Combination of Pegasys(R) and Copegus(R)
Yields Response in Over 60 Percent of Patients
Source: PRNewswire
LA JOLLA, Calif.,-- A landmark study examining
the efficacy and safety of the drug combination Pegasys(R)
(peginterferon alfa-2a), a pegylated interferon, with Copegus(R)
(ribavirin), an antiviral medication, has found the most significant
response rates ever achieved in patients infected with hepatitis
C, according to Paul Pockros, M.D., at Scripps Clinic. The
combination treatment yielded a 61 percent sustained virologic
response (SVR), the highest SVR ever reported in a clinical
trial for a pegylated interferon.
SVR refers to a patient's continued undetectable
serum hepatitis C (HCV) RNA levels six months after discontinuation
of treatment. The results of the study were published in this
week's Annals of Internal Medicine.
Hepatitis C is a blood-borne virus that
attacks the liver, causing cirrhosis (liver scarring) and
liver cancer, and is the primary reason many patients undergo
liver transplants in the U.S. An estimated 4 million Americans
are infected with hepatitis C, with 2.7 million chronically
infected.
"The outcome of this study provides
critical insights for treating the 35,000 people being diagnosed
each year with hepatitis C," explained Pockros, a U.S.
investigator in the trial and head of the division of gastroenterology
and hepatology at Scripps Clinic in La Jolla, Calif. "Most
notably, we can now say that the virus can be cured in more
than half of the patients treated."
The study also revealed clinical evidence
that, to achieve optimal results, treatment duration should
be based on hepatitis C virus genotype, rather than on the
traditional, weight-based methodology.
Additionally, the study found a 51 percent
SVR, the highest ever achieved, for patients with genotype
1, the most difficult to treat and most prevalent genotype.
The study also confirms that these patients require a year
of treatment (48 weeks) with Pegasys and the standard dose
of ribavirin (daily 1000mg /1200mg) in order to achieve the
optimal outcome. The success rate was even higher for genotype
non-1 patients, with 78 percent achieving an SVR after only
24 weeks of therapy and a low daily 800mg dose of ribavirin.
"This is the first study to confirm
that for certain patients, we can use a lower dose of therapy
and cut the treatment duration by half without sacrificing
efficacy. Potentially, this can save some patients nearly
six months of unnecessary treatment," said Pockros.
In addition to Scripps Clinic, the randomized,
multi-center study had a total of 99 sites around the world
and included 1,284 patients stratified by genotype into one
of four treatment groups:
- PEGASYS 180 ug qw + ribavirin 800 mg
qd for 24 weeks
- PEGASYS 180 ug qw + ribavirin 1000-1200
mg qd for 24 weeks
- PEGASYS 180 ug qw + ribavirin 800 mg
qd for 48 weeks
- PEGASYS 180 ug qw + ribavirin 1000-1200
mg qd for 48 weeks
In this study, the adverse events were
similar to previous reported trials and included flu-like
symptoms, fatigue and depression.
Founded in 1924, Scripps Clinic is a multi-specialty,
outpatient care facility caring for patients at multiple locations
throughout San Diego County. Scripps Clinic and its physicians
are world-renown for research- driven care and medical specialty
expertise and is an operating unit of Scripps Health, a not-for-profit,
community-based health care delivery network that includes
more than 2,600 affiliated physicians, five acute-care hospitals,
home health care and associated support services. Scripps
Health is one of the largest health care organizations in
San Diego County, drawing from the expertise of more than
10,000 health care professionals.
Source: Scripps Clinic
CONTACT: Johny Hagerman of Scripps Clinic, +1-858-678-6878
Web site: http://www.scrippsclinic.com/
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H3 Pharma
Submits New Drug Application To FDA For Sanvar IR
Source: BioSpace
MONTREAL-PRNewswire- H3 Pharma Inc., a
Montreal-based pharmaceutical Product Development Company,
today announced the submission of a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) in Washington
DC for Sanvar(R) IR. The product candidate is a somatostatin
analog in an immediate-release formulation to be used in acute
treatment of esophageal variceal bleeding (EVB) to stop hemorrhage
prior to endoscopic intervention and to prevent recurring
bleeding during the critical five days following treatment.
EVB is a life-threatening event with a high mortality rate
that accounts for approximately 7% of episodes of gastrointestinal
bleeding in North America and Europe and occurs in approximately
30% of patients with portal vein hypertension caused by cirrhotic
liver disease induced by hepatitis infection. The global market
for somatostatin is expected to reach US$1.5 billion by 2005.
"I am very pleased that H3 Pharma
has become one of the few companies in Quebec to submit an
NDA and has been able to do so within the tight timeframe
we had planned," said Dr. Loic Maurel, President and
CEO of the Company. "The submission of this NDA moves
us significantly closer to commercialization of this product
candidate. We are now in active discussions with a number
of pharmaceutical companies to conclude commercialization
agreements in the key world markets of the Americas and Europe
this year. The orphan-drug status we have received in the
U.S.A. will give us exclusivity in that market for seven years
following approval and we expect to enter the U.S. market
in 2005," he added.
"I want to thank our dedicated staff
for their enormous efforts to move this product candidate
forward quickly and I want to acknowledge the excellent work
of the team at Debiopharm S.A. in Lausanne, Switzerland, who
advanced the development work so effectively up until our
in-licensing of the product last July," said Dr Maurel.
Sanvar(R) IR is the only somatostatin analog
to demonstrate success versus placebo in the treatment of
acute EVB, in a well powered and designed Phase III clinical
study conducted in 227 patients in 22 centers. Sanvar(R) IR
significantly reduced active bleeding. Survival with hemostasis
at 5 days was achieved significantly (p equal 0.021) more
often with Sanvar(R) IR than with placebo. In patients with
control of bleeding at day 5, Sanvar(R) IR significantly (p
equal 0.006) increased hemostasis and survival through day
42. Sanvar(R) IR will therefore be used valuably in association
with endoscopic treatment to improve hemostasis in emergency
in cirrhotic patients presenting variceal bleeding.
The Sanvar(R) IR formulation was submitted
for registration in Mexico in December 2003. European submission
is planned for late 2004.
Sustained-Release Formulation Also
Under Development in Other Indications
The Company is also developing a three-month
sustained release (SR) formulation of Sanvar(R) for the management
of life-long symptoms of carcinoid tumors and acromegaly for
which it was granted orphan-drug designation by the FDA in
November 2003. The sustained release formulation offers significant
therapeutic advantages over other somatostatin analogues in
the treatment of these diseases. Sanvar(R) has demonstrated
positive effects on the clinical symptoms of Crohn's disease
as well, and further clinical development will begin this
spring. H3 Pharma plans to sign out-licensing agreements for
all Sanvar(R) indications and formulations this year.
About H3 Pharma
H3 Pharma Inc., based in Montreal, is a pharmaceutical Product
Development Company with extensive internal expertise and
world-renowned advisory panels that focuses on products in
both oncology and endocrinology. H3 Pharma bridges the gap
between innovative products and the global pharmaceutical
marketplace by in-licensing the most promising therapeutic
discoveries (post proof-of-concept in humans) and then managing
the clinical development, intellectual property, global registration
and manufacturing planning prior to out-licensing the products
for global commercialization. H3 Pharma Inc. is an international
joint venture between SGF Health, a division of SGF, one of
Canada's largest venture funds, and Debiopharm S.A., a privately
owned company based in Lausanne, Switzerland. To find out
more about the company, visit WWW.H3PHARMA.COM.
All of the statements contained in this
news release, other than statements of fact that are independently
verifiable at the date hereof, are forward-looking statements.
Such statements, based as they are on the current expectations
of management, inherently involve numerous risks and uncertainties,
known and unknown. Some examples of known risks are: the impact
of general economic conditions, general conditions in the
pharmaceutical industry, changes in the regulatory environment
in the jurisdictions in which H3 Pharma does business, stock
market volatility, fluctuations in costs, and changes to the
competitive environment due to consolidation or otherwise.
Consequently, actual future results may differ materially
from the anticipated results expressed in the forward- looking
statements.
H3 PHARMA INC.
CONTACT: For additional information, please contact:Margaret
Bywater-Champagne, Vice President, Business Development &
Licensing,H3 Pharma Inc., mbywater@h3pharma.com,
(514) 842-9976, Fax: (514) 842-5430;Nathalie Bourque, National
Public Relations, nbourque@national.ca,
(514)843-2309, Fax: (514) 843-6976.
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Body Pain
May Hinder Depression Treatment: Study
Source: Reuters Health
Amy Norton
NEW YORK - People who report having physical
pain along with depression may be less likely to respond to
antidepressant drugs, new study findings suggest.
Although more research is needed, the findings
imply that doctors need to address any bodily pain when treating
patients for depression, the study's lead author told Reuters
Health.
Researchers found that among nearly 600
patients treated with antidepressants called selective serotonin
reuptake inhibitors (SSRIs), those who reported recent pain,
such as headaches and back pain, were less likely than the
pain-free patients to show improvement in their depression.
And the more severe the pain, the less
likely depression treatment was to work, Dr. Matthew J. Bair
and his colleagues report in the journal Psychosomatic
Medicine.
They found that patients who reported severe
pain were four times more likely than those with no pain to
show a poor response to antidepressants. Moderate and mild
pain was also linked, to a lesser degree, to poorer treatment
response, according to the report.
The researchers also found that most—69
percent—of the subjects reported pain at the start of
the study. Of these patients, 30 percent reported moderate
pain, 25 percent reported mild pain, and 15 percent said their
pain was severe.
"Pain commonly goes along with depression,"
said Bair, who is with the Roudebush VA Medical Center in
Indianapolis.
Although the relation between the two is
not fully understood, it's thought that people with depression
might be more sensitive to bodily pain, Bair explained in
an interview.
Much of the research on pain and depression
has focused on the role of chronic pain in the development
of depression. What's been unclear, Bair's team notes in the
report, is whether pain hinders depression treatment.
To investigate, they looked at data from
a U.S. study of 573 adults treated with one of three SSRIs:
fluoxetine (Prozac), paroxetine (Paxil) or sertraline (Zoloft).
For that study, participants completed surveys on health-related
quality of life, which included questions on pain before and
after starting treatment.
Most of the study participants were women
and most were white, and the average age was 46 years.
The current work was funded by Prozac maker
Eli Lilly and Co.
Although most patients in the study improved
within three months of starting drug therapy, one quarter
were deemed "poor responders." Those who reported
pain at the study's start were at greater risk of a poor response.
Bair said the findings suggest "we
should be assessing both pain and depression." If both
are present but only the depression is treated, response to
depression therapy might be compromised, he noted.
Bair cautioned, though, that his study
was retrospective, and based on a trial whose primary focus
was not pain.
What's needed now, he pointed out, is a
study to look at whether pain medication given along with
antidepressants makes a difference in patients' treatment
response.
SOURCE: Psychosomatic Medicine, January/February 2004.
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Approved
Injection Sites Create State 'Complicity' in Drug Abuse: UN
Agency
LISA SCHLEIN
Source: Canadian Press
GENEVA (CP) - A UN organization has expressed
concerns to Canada over Vancouver's safe injection site for
addicts, saying the approach violates international agreements
on ways to control drug abuse.
In a report released Wednesday, the International
Narcotics Control Board says the establishment of the drug-injection
site in Vancouver last year - the first in North America -
"is not in line with the international drug-control treaties
to which Canada is a party." The board is part of the
UN International Drug Control Program based in Vienna. It
notes that governments have agreed to use prevention and treatment
to deal with drug abuse.
The report says the board has on numerous
occasions spoken out against the operation of drug injection
rooms "where persons can inject drugs acquired with impunity
on the illicit market."
Herbert Schaepe, secretary of the board,
says board members have expressed concerns to the Canadian
government, as well as several European governments that have
approved drug injection sites or are thinking of establishing
them.
"When drug abusers can acquire illicit
drugs and can take these illicit drugs into premises which
are managed by the state or the town, then there is definitely
complicity and we cannot accept that under the international
drug control convention," he says.
Health Canada announced last June it would
provide $1.5 million over four years for the pilot project
in Vancouver to determine whether a supervised injection site
can reduce harm to addicts and improve their health prospects.
Schaepe dismisses arguments put forth by
government authorities, notably Switzerland, that rooms where
heroin addicts can safely inject themselves under medical
supervision have reduced crime, improved the lives of addicts
and persuaded many to check into rehabilitation centres.
"We can achieve exactly the same through
other methods," Schaepe says. "We think that we
should stick to the international conventions which call for
prevention and for treatment."
The report also calls cannabis "the
most abused drug in North America" and says it continues
to be produced in large quantities in Canada, the United States
and Mexico.
The board says it is troubling that more
lenient legislation on marijuana is being considered, saying
it is "concerned that the revisions could contribute
to the mistaken perception that cannabis is a harmless substance."
Schaepe says cannabis is involved in 25
per cent of all drug addicts who ask for treatment in the
European Union. "So, cannabis is not so inoffensive as
it often is claimed to be in many of the articles you can
find in the worldwide media."
In other areas, the board says Canada has
made welcome improvements.
It approves of the new regulations Canada
has implemented for internationally controlled psychotropic
substances and the introduction of better control over precursor
chemicals used in the manufacture of cocaine, heroin and synthetic
drugs such as methamphetamines.
Schaepe says the introduction of a law
to control the movement of these chemicals has improved co-operation
between United States and Canada in preventing such transactions.
"On the Canadian side that was not
possible before the law came into force," Schaepe says.
"Now that the people can be put to the court, that has
improved very much this last year."
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March 3rd, 2004
New York
Times Profiles Head of New York-Based Harm Reduction Coalition
Source: Kaiser Daily HIV/AIDS Report
The New York Times on Wednesday profiled
Allan Clear, executive director of the New York City-based
Harm Reduction Coalition, a not-for-profit group that promotes
needle-exchange programs to help reduce harm, including possible
HIV infection, linked to injection drug use. Clear, who was
formerly associated with the AIDS advocacy group ACT UP, was
"involved in underground needle exchange years before
the state ... provided waivers to some community groups to
do it legally," the Times reports. In 1995, he was hired
to run the coalition -- which also develops public policy
and trains social workers -- and he moved the group's headquarters
from San Francisco to New York City. The group is currently
working with state and city officials to help establish a
needle-exchange program in Queens that would be administered
by the AIDS Center of Queens County. There are currently no
needle-exchange programs in Queens, and there is "some
resistance" to starting such programs, according to the
Times. Clear said, "Harm reduction is not making drug
use solely acceptable, but it's accepting that people use."
He added, "Being an advocate for the health of drug users
is not a popular thing. But I wouldn't do this if I wasn't
overly optimistic" (Richardson, New York Times, 3/3).
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New Onset
Diabetes Mellitus After Liver Transplantation
Source: www.gastrohep.com
De novo diabetes is common in liver transplant
recipients, find doctors in the March issue of Liver Transplantation.
Epidemiological studies suggest an association
between diabetes mellitus (DM) and chronic hepatitis C virus
(HCV) infection.
Both of these conditions are common in
liver transplant recipients. In this study, doctors from San
Francisco, California, evaluated a cohort of 555 liver transplant
recipients without preexisting diabetes. Patients were from
3 US centers.
The team followed patients for a median
of 5 years. De novo diabetes developed in 38% of patients.
They defined de novo diabetes by the use
of antidiabetic medications.
The team found that de novo diabetes developed
in 38% of patients.
Of these, 28% had transient-DM (T-DM) and
9% had persistent-DM (P-DM).
The doctors found that in the HCV-infected
transplant recipients, de novo T-DM and P-DM developed in
26% and 14%, respectively. They established that HCV was predictive
of P-DM but not of T-DM.
The team also found that older age and
tacrolimus use were independent predictors of P-DM.
Dr Mandana Khalili's team concluded, "De novo diabetes
is common in transplant recipients, but is typically transient
in nature".
"However, among those developing de
novo persistent diabetes, HCV is one of the most important
risk factors".
"This adds further support to the
epidemiological data linking HCV and diabetes".
Liver Transpl 2004; 10: 349-55
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Antibiotics
After Endoscopic Therapy Prevent Rebleeding
Source: www.gastrohep.com
Antibiotic prophylaxis can prevent infection
and rebleeding in patients with acute gastroesophageal variceal
bleeding following endoscopic treatment, find physicians in
the March issue of Hepatology.
Bacterial infection may adversely affect
the hemostasis of patients with gastroesophageal variceal
bleeding (GEVB).
In this study, physicians from Taiwan evaluated
patients with acute GEVB but without evidence of bacterial
infection over a 25 month period.
Patients were randomized to receive either
prophylactic antibiotics (n=59) or antibiotics only when infection
became evident (n=61) (on-demand group).
The team performed endoscopic therapy for
GEVB immediately after infection work-up and randomization.
The physicians found that antibiotic prophylaxis
significantly decreased infections.
In addition, they determined that the actuarial
probability of rebleeding was higher in patients without prophylactic
antibiotics.
The team established that the difference
in rebleeding was mainly due to early rebleeding within 7
days. They calculated that the relative hazard of rebleeding
within 7 days was 5.078.
They found that bacterial infection (relative
hazard 3.85) and hepatocellular carcinoma (relative hazard
2.46) were independent predictors of rebleeding.
The need for blood transfusion for rebleeding
was reduced in the prophylactic group.
The physicians found no difference in survival
between the 2 groups.
Dr Ming-Chih Hou and colleagues concluded,
"Antibiotic prophylaxis can prevent infection and rebleeding
as well as decrease the amount of blood transfused for patients
with acute GEVB following endoscopic treatment".
Hepatology 2004; 39(3): 746-53
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Ancient
Virus May Help HIV Patients Live Longer: Apparently harmless
germ related to hepatitis seems to boost immune system
Randy Dotinga
Source: HealthDay Reporter
Researchers think they've confirmed the
unlikely notion that a seemingly harmless viral infection
helps people with HIV live longer.
The workings of the virus are far from
clear, and scientists can't guarantee it's utterly benign.
But study findings seem to suggest it somehow strengthens
the immune systems of these patients.
"This puts the final nail in the coffin
of people who doubted this effect because it's so odd,"
says Dr. Roger Pomerantz, director of the Center for Human
Virology and Biodefense at Thomas Jefferson University in
Philadephia. He wrote a commentary about the new study that
appears in the March 4 issue of the New England Journal
of Medicine.
Although it's apparently an ancient germ,
GBV-C — also known simply as "virus G" —
was only discovered in the mid-1990s. At first, scientists
thought the virus was responsible for one of the potentially
deadly liver diseases known as hepatitis. Later, they realized
it didn't seem to cause any symptoms, even when the body's
immune system failed to clear it away. But it still seems
related to hepatitis.
Like hepatitis B, the virus is spread through
exposure to blood and sexual contact. Research among healthy
blood donors suggests it infects about 1.5 percent to 2 percent
of the population, and about 13 percent have had it in the
past, says study co-author Dr. Jack Stapleton, director of
the University of Iowa HIV Program.
"The majority of healthy people who
get this infection clear it and develop antibodies, much like
many other viral infections like measles and hepatitis A,"
Stapleton says. Antibodies are the immune system's specialized
soldiers in waiting, trained to attack certain kinds of germs.
Over the past several years, scientists
have linked the presence of virus G to longer lifespans in
those infected with HIV. In the new study, the most extensive
of its kind, scientists examined the medical records of 271
men who became HIV-positive while they were taking part in
a large American research project before the advent of powerful
AIDS drugs nearly a decade ago.
Eighty-five percent of the men showed signs
of virus G infection. And the men who didn't were 2.78 times
more likely to die after five to six years than those who
were persistently infected with the virus.
"If you have G virus, you're less
likely to progress [to end-stage AIDS]," Pomerantz says.
"It doesn't mean you won't progress. It means you'll
be less likely to."
Those who had been infected with virus
G but cleared it were even more likely to die, Stapleton says.
This may be because HIV robbed the virus of immune cells to
target.
So what's at work with virus G? The germ
could somehow prime the immune system to effectively tackle
the AIDS virus, Pomerantz says. Or perhaps something else,
yet to be discovered, is at work, he adds.
However, Pomerantz doesn't think those
infected with HIV should run out and try to get infected with
virus G. "That's a real leap and asking for trouble,
especially since we have no idea how it works," he says.
The next step: Figure out what's happening
with virus G and, if possible, replicate it, Stapleton says.
"If we could figure out a way to maintain [virus G] infection,
then potentially we would have a disease-modifying treatment
or vaccine."
More information
Virus G seems to be related to the various types of hepatitis;
to learn more about hepatitis A, check with the U.S. Centers
for Disease Control and Prevention. To get details about federal
guidelines regarding AIDS treatment, visit AIDSinfo - http://www.aidsinfo.nih.gov/.
SOURCES: Jack Stapleton, M.D., director,
University of Iowa HIV Program, Iowa City; Roger Pomerantz,
M.D., F.A.C.P., chief, Center for Human Virology and Biodefense,
Thomas Jefferson University, Philadelphia; March 4, 2004,
New England Journal of Medicine.
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Medical
Services International Inc. Intensifies Hepatitis B Testing
Source: PRNewswire
Medical Services International Inc. (Pinksheets:
MSITF) is pleased to announce that at the request of regulatory
authorities in the People's Republic of China that it has
increased the rate of testing of its VScan rapid test kit
for Hepatitis B. Based on the results obtained from independent
and regulatory testing to date, Medical Services has been
asked to ship enough Hepatitis B VScan test kits to China
to immediately begin the approval process. The appropriate
number of Hepatitis B test kits for the regulatory testing
will be shipped by March 5, 2004. The Company has been assured
that the testing will be given priority. The infection rate
for Hepatitis B in China exceeds 30%. The Company has received
the same request from other countries over the last several
weeks. The results obtained to date show that the accuracy
of the Hepatitis B test kit is greater than 99%.
About VScan
The VScan rapid test kit is a single use, disposable, accurate
(greater than 99%), cost effective, easy to use, test for
rapid screening of HIV 1&2 and subgroup O, Hepatitis B&C,
Tuberculosis (TB) and West Nile. The kits cannot be sold in
Canada.
Medical Services International Inc. trades
in the United States on the NQB Pinksheets under the symbol
"MSITF". For further information, please contact
Robert Talbot at (780) 430 6363 or Bill Whitehead Jr. at (416)
822 5883 or http://www.medicalservicesintl.com/.
NOTE: Certain statements
in this press release are "forward-looking statements"
within the meaning of the Private Securities Act of 1995.
Such statements involve known and unknown risks, uncertainties
and other factors that may cause results to differ materially.
Such risks, uncertainties and other factors include but are
not limited to new economic conditions, risk in product technology
development, market acceptance of new products and continuing
product demand, level of competition and other factors described
in Company reports and other filings with regulatory bodies.
Medical Services International Inc.
CONTACT: Robert Talbot, +1-780-430-6363, or Bill
Whitehead Jr.,+1-416-822-5883, both of Medical Services International
Inc.
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FDA Launches
New Easy-to-Use Drug Information Web Site
ROCKVILLE, MD --- As part of its continuing
efforts to see that patients and consumers have the information
they need to make informed choices, the Food and Drug Administration
(FDA) today launched a new easy-to-use web site to help consumers
and health professionals find information about FDA-approved
drug products more quickly and efficiently.
The new interface, Drugs@FDA
- http://www.accessdata.fda.gov
/scripts/cder/drugsatfda/ is a searchable database that includes
information on approved prescription drugs, some over-the-counter
drugs, and discontinued drugs. Located on the web page of
FDA's Center for Drug Evaluation and Research (CDER), it is
the first web resource to offer a comprehensive overview of
a drug product's approval history. "Better information
for consumers and health care practitioners is one of this
agency's top priorities," said FDA Commissioner Mark
B. McClellan M.D., Ph.D. "Consumers, health care professionals,
and product developers will now be able to locate the complete
profile of a product with just a few easy clicks."
Drugs@FDA makes all drug approval information
available on one site so that users no longer have to visit
several web pages for information on brand name and generic
drugs. The database incorporates information from all parts
of CDER's website, including Consumer Information Sheets,
Medication Guides, labeling, and other information for patients.
Eventually information on recalls, warnings, and drug shortages
will also be included.
Users can easily search or browse this
site by drug name or active ingredient to retrieve a complete
approval history and accompanying documents for a particular
drug product. Users can also find out if therapeutic equivalents
exist including generics for brand name drugs. For example
users can:
• Get the latest FDA information,
including consumer-focused information like Medication Guides,
for drugs they have been prescribed or that their doctor is
considering.
• Identify therapeutically equivalent drugs for prescription
medicines, and alternative OTC drugs with the same active
ingredient, to help them identify the medicine that is best
for them.
• Determine whether generic equivalents exist for their
brand name drugs.
Source: The Food and Drug Administration.
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March 5th, 2004
Valeant
Pharmaceuticals International (VRX) Reports Published 24-Week
Data Abstracts For Viramidine
Source: PRNewswire
COSTA MESA, Calif.-- Valeant Pharmaceuticals
today reported that a portion of its 24-week data from the
Viramidine(TM) Phase 2 clinical trial was published by the
European Association for the Study of the Liver (EASL) on
its Web site. Valeant had submitted the 24-week data for presentation
at the upcoming EASL Conference in Berlin, Germany. Valeant
is developing Viramidine, a nucleoside (guanosine) analog,
in oral form for the treatment of hepatitis C in conjunction
with a pegylated interferon.
The 24-week data shows that Viramidine
demonstrated antiviral activity comparable to that of ribavirin,
when used in combination with peginterferon alfa-2a in treatment
naïve patients, but with a significantly lower incidence
of anemia.
Specifically, the portion of the data released
by EASL shows that following 24 weeks of treatment, there
was no significant difference between Viramidine (800-1600
mg/day) versus ribavirin in the proportion of patients with
greater than or equal to 2 log10 reduction or non-detectable
HCV RNA (83 percent versus 83 percent, respectively). There
were also significantly fewer patients in the Viramidine groups
with anemia (hemoglobin < 10g/dL) when compared with the
ribavirin arm (2 percent versus 24 percent; p < 0.001).
Among patients receiving the 400 mg BID and 600 mg BID doses
of Viramidine, there were no cases of defined anemia. Other
adverse events were similar among treatment groups.
The full 24-week data for the Phase 2 clinical
trial will be presented at the EASL Conference.
A Phase 3 clinical trial of Viramidine
compared to ribavirin in combination with pegylated interferon
was initiated in the fourth quarter of 2003.
About Valeant
Valeant Pharmaceuticals International is a global, publicly
traded, research-based specialty pharmaceutical company that
discovers, develops, manufactures and markets a broad range
of pharmaceutical products. More information about Valeant
can be found at http://www.valeant.com/.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of the federal securities laws relating to expectations,
plans or prospects for Valeant Pharmaceuticals, including
funding and conducting clinical trials and expected research
and development expenses. These statements are based upon
the current expectations and beliefs of Valeant Pharmaceuticals'
management and are subject to certain risks and uncertainties
that could cause actual results to differ materially from
those described in the forward- looking statements. These
risks and uncertainties include market conditions and other
factors beyond Valeant Pharmaceuticals' control, the company's
success in identifying and enrolling patients in the clinical
trials program, the absence of adverse events that would require
the clinical trials to be prematurely terminated, clinical
results that indicate continuing clinical and commercial pursuit
of Viramidine is advisable, and the risk factors and other
cautionary statements discussed in Valeant Pharmaceuticals'
filings with the U.S. Securities and Exchange Commission.
For further information please contact: Jeff Misakian of Valeant
Pharmaceuticals, +1-714-545-0100, ext. 3309.
Valeant Pharmaceuticals
CONTACT: Jeff Misakian of Valeant Pharmaceuticals,
+1-714-545-0100, ext.3309
Web site: http://www.valeant.com/
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Compensation
for Mum Infected by Transfusion
Natalie Paris
Source: http://www.suttonguardian.co.uk/
A mother who contracted Hepatitis C from
a blood transfusion has scored a victory in her fight for
compensation more than 30 years after she was infected.
Gill Pearson, 58, of Clifton Road, Wallington, believes she
contracted the illness at St Helier Hospital when she was
given blood after losing five pints following the birth of
her daughter in 1971.
Government health chiefs had previously
insisted only current sufferers would benefit from compensation
but the scheme has now been extended to include those who
have cleared the virus.
Delighted Mrs Pearson, who is on the road
to recovery, told the Comet of her joy this week after learning
she could receive a £20,000 lump sum to compensate decades
of suffering.
She has been fighting for compensation
for more than four years with the help of MP Tom Brake.
He said: "The extension of the eligibility
criteria to those who have recovered from the disease is a
triumphant step towards getting people the compensation they
deserve and holding the Department of Health (DoH) responsible
for aiding those affected by the disease under NHS care.
"This compensation should go towards
alleviating the suffering of Hepatitis C victims."
Mrs Pearson is now in the last month of
treatment for the virus, which is passed on through direct
contact with blood.
In its advanced stage, Hepatitis C causes
cirrhosis or liver cancer.
Despite suffering with muscle fatigue and
even being told by one GP her liver resembled that of an alcoholic's,
Mrs Pearson's condition was not diagnosed until 1999.
She said: "It is normally 20 or 30
years before the symptoms show and I had all that time with
various illnesses, and I didn't know why.
"My GP had the shock of his life when
he found out.
"He asked me whether I had ever done
drugs and I said no', so he asked if I had had a blood transfusion
and I said yes' and he said it must have been that."
Although Mrs Pearson is fairly sure her
daughter has not been infected, the years spent raising her
while being unaware of her condition put her at risk.
A spokesman for St Helier Hospital, where
Mrs Pearson says she contracted the disease, said it could
not trace the individual case, but confirmed Hepatitis C was
not discovered until 1989 and a test was introduced in 1991
two decades after Mrs Pearson's blood transfusion.
The spokesman added blood supplied to all
NHS trusts comes from the National Blood Service, which screens
for transfusion-transmitted diseases.
According to the DoH, every person
whose infection is found to be attributable to NHS treatment
before September 1991 will be eligible for the payments, including
those contracting the disease from someone already infected.
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