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Alan Franciscus
Editor-in-Chief
To download pdf version click here
In This Issue:
Can Treating HCV Prevent
Progression to Cirrhosis?
Hepatitis Link to Pigs May Hit Transplant Hopes
Vermont: Group Wants Needle Exchange to Go Mobile
Par Pharmaceutical Announces Receipt of Approvable
Letter From FDA for Ribavirin Capsules
VA Launches New Web Site on Hepatitis C
Civacir(TM) Phase I/II Trial in Hepatitis C Liver
Transplant Patients Completed, Preliminary Results Encouraging
ViroPharma Initiates Phase 1 Hepatitis C Program
With HCV-086
Lamivudine for Prevention of Chemotherapy-Induced HBV Reactivation
Bad Blood Lingers Over Jail Donors
Do-It-Yourself Tattoos Worry Officials
Peginterferon Alpha 2a versus Interferon Alpha
2b Plus Ribavirin in Chronic Hepatitis C
Schering-Plough, Continuing Cost Cuts, Lays
Off 200
Schering-Plough Sees Tax Refund Over $400M In
'04
Schering-Plough CEO Urges Drug-Subsidy Foundation
Hepatitis Drug-Maker Complaints Reviewed
February 20th, 2004
Can
Treating HCV Prevent Progression to Cirrhosis?
Henry Bodenheimer
Source: www.gastrohep.com
Hepatic fibrosis is a progressive insult
responsible for morbidity and mortality in chronic hepatitis
C infection. Thierry Poynard in his 1999 paper in Hepatology
analyzed a large data set of liver biopsies in patients with
hepatitis C and suggested that liver fibrosis progression
was not uniform in individuals infected with hepatitis C.
Some individuals appear to progress slowly while others rapidly
progressed to cirrhosis. This dichotomy is perhaps most widely
recognized in patients who have under gone liver transplantation.
Patients with recurrent hepatitis C following transplant may
develop cirrhosis in as short an interval as 4 to 5 years
while progression to cirrhosis in a non-transplant setting
typically takes 2, 3 or more decades.
Multiple factors have been identified as
contributing to progression of fibrosis in hepatitis C. Three
of the factors identified deserve highlighting:
Alcohol consumption is a modifiable cofactor
which has been associated with more rapid progression of liver
fibrosis. Although regular consumption of alcohol at levels
more than 50gms of alcohol per day has been linked with rapid
progression of disease, no safe level of alcohol consumption
has been identified. It is wise therefore that patients with
chronic hepatitis C infection avoid alcohol consumption.
A second factor associated with disease
progression is fatty liver. Non-alcoholic fatty liver disease
is increasingly recognized as a co-factor in disease progression
in patients with various underlying liver conditions. This
disorder is difficult to treat and pathogenesis may, in part,
be related to insulin resistance associated with hyperlipidemia,
diabetes and obesity. Hepatitis C infection itself, however,
may contribute to lipid eposition within the infected liver.
It is advisable that modifiable factors such as body weight,
hyperlipidemia and insulin resistance be addressed and treated
in patients with chronic hepatitis C infection.
A third factor which is not able to be
modified but is associated with disease progression is the
acquisition of HCV at an age greater than 40 years. Older
patients appear to have more rapid progression of fibrosis
than younger patients. Such information may be important in
assessing prognosis and need for antiviral treatment.
A major question is whether liver fibrosis
is reversible. Patients with established fibrous septa have
shown gradual resolution of fibrosis with years of effective
control of viral replication. The question remains, whether
decrease in hepatic fibrosis in patients undergoing treatment
for hepatitis C is a direct result of anti-fibrotic effect
of alpha interferon, or is the beneficial effect a consequence
of viral control. A recent report by Poynard in Gastroenterology
2002, addressed this question. Greater than 80% of liver biopsies
evaluated in patients with sustained virologic response showed
improved fibrosis while less than 10% showed a worsening.
In contrast, less than 34% of individuals who showed non-response
to interferon showed improvement in fibrosis while more than
20% showed a worsening. Such data suggest that the primary
mechanism by which fibrosis is diminished in patients treated
with alpha interferon is through control of viral replication.
In summation, chronic hepatitis C infection
is an epidemic infection leading to chronic liver injury with
hepatocyte necrosis subsequent inflammation and stimulation
of hepatic fibrosis. This chronic process gradually leads
to cirrhosis. Fortunately, with control of viral replication
modulation of the intercellular matrix is possible and alpha
interferon treatment regimens generating sustained virologic
response are associated with improvement in hepatic fibrosis
and even resolution of cirrhosis. In the future, assessment
of hepatic fibrosis may be possible with non invasive assays
and direct anti-fibrotic therapy maybe available to be coupled
with inhibitors of viral replication to maximize the resolution
of hepatic injury.
This "Soapbox" was published
as part of the syllabus for the New York Society for Gastrointestinal
Endoscopy 27th Annual Postgraduate Course - Endoscopic Decision
Making 2003, held in New York, NY. 15 and 16 December 2003.
See the NYSGE website.
References
• Castilla A, Prieto J, Fausto N. Transforming growth
factors beta 1 and alpha in chronic liver disease. Effects
of interferon alfa therapy. N Engl J Med1991; 324: 933-40.
• Yano M, Kumada H, Kage M, et al. The long-term pathological
evolution of chronic hepatitis C. Hepatology 1996: 23: 1334-40.
• Poynard T, Dedossa P, Opolon P. Natural history of
liver fibrosis progression in patients with chronic hepatitis
C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet
1997; 349: 825-32.
• Shiffman ML, Hofmann CM, Contos MJ, et al. A randomized,
controlled trial of maintenance interferon therapy for patients
with chronic hepatitis C virus and persistent viremia. Gastroenterology
1999; 117: 1164-72.
• Wanless IR, Nakashima E, Sherman M. Regression of
human cirrhosis. Morphologic features and genesis of incomplete
septal cirrhosis. Arch Pathol Lab Med 2000; 124(11): 1599-607.
• Alric L, Duffaut M, Selves J, et al. Maintenance therapy
with gradual reduction of interferon dose over one year improves
histological response in patients with chronic hepatitis C
with biochemical response: results of a randomized trial.
J Hepatol 2001; 35: 272-8.
• Poynard T, McHutchinson J, Manns M, et al. Impact
of pegylated interferon alfa-2b and ribavirin on liver fibrosis
in patients with chronic hepatitis C. Gastroenterology 2002;
122: 1303-13.
• Ghany MG, Kleiner DE, Alter H, et al. Progression
of fibrosis in chronic hepatitis C. Gastroenterology 2003;
124: 97-104.
• Dienstag JL, Goldin RD, Heathcote EJ, et al. Histological
outcome during long-term lamivudine therapy. Gastroenterology
2003; 124: 105-17.
Back to top
February 21st, 2004
Hepatitis
Link to Pigs May Hit Transplant Hopes
James Meikle, health correspondent
Source: The Guardian
Britons might be catching hepatitis from
pigs, a hypothesis that could undermine hopes of eventually
using pigs’ organs to cut waiting lists for human transplants,
it emerged yesterday.
Vets investigating the prevalence of the
hepatitis E virus in British herds found its signature looked
like a strain identified in a human. The disease is rare in
Britain, most of the 30 to 40 cases a year being people who
have traveled to developing countries where hygiene is poorer.
It is often endemic in pig herds in such countries.
It is usually mild compared with hepatitis
B and C, which can lead to chronic disease, but it can cause
severe liver failure in pregnant women.
Researchers from the government's Veterinary
Laboratories Agency, writing in the Veterinary Record, have
warned that the disease, which seems to have been well established
in pigs for a decade, might on rare occasions leap from animals
to humans. Pigs appear to carry the virus without symptoms
and many humans may be carriers too, so hepatitis E might
be more widespread than clinical cases suggest.
Xenotransplantation, using animal organs
in humans, is still some years away but experiments between
animal species have been attempted for some time. Pig cells
may help cure diabetes, if experiments using monkeys are any
guide, while scientists have tried to transplant piglets'
hearts to baboons.
But there have long been fears that diseases
harmless to pigs might turn into killer viruses when transferred
to humans, undermining hopes that humans could soon have life-saving
heart, liver or kidney transplants from specially bred GM
pigs. No near-human trials are even near development in Britain.
The virus found in young pigs from farms
in Bedfordshire and Suffolk was very like that found in a
patient from Cornwall who had not traveled outside Britain
for more than four years, according to yesterday's report.
"Further work is needed to establish more precisely the
extent and impact, if any, of infection in pigs and people
in the UK and other countries," it said.
But "limited data" so far suggested
transmission between species could not be ruled out. The presence
of such potential animal-to-human viruses "also has implications
in the field of xenotransplantation."
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February 23rd , 2004
Vermont:
Group Wants Needle Exchange to Go Mobile
Associated Press (02.20.04)
On Feb. 20, the St. Johnsbury Vermont CARES
Community Advisory Board met to review an amendment to the
statewide Organized Community- Based Needle Exchange Program
operating guidelines. The group hopes to get the state health
commissioner to approve a plan for a mobile exchange program
in which peer outreach workers would give out needles in the
community rather than just at approved clinics. The Health
Department approved the concept of a mobile exchange program
last year, but rules need to be established before it can
begin, according to Kendall Farrell, executive director of
Vermont CARES.
Under the terms of the current proposal,
peer outreach workers would receive a stipend and follow a
lengthy list of guidelines before distributing needles. The
well-trained workers would provide drug users with a safe
means of using intravenous drugs while educating them on health
and safety issues such as safe sex. Farrell said there are
many barriers to getting people into a site-based program;
a mobile outreach would bring prevention materials and education
to people who need the service.
St. Johnsbury is one of three Vermont towns
that host exchange clinics. The others are Burlington and
Brattleboro. Farrell said there are already six trained outreach
workers in the St. Johnsbury area ready to bring needles and
education to the streets. The next step is getting the health
commissioner's approval.
Source: AEGIS
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Par Pharmaceutical
Announces Receipt of Approvable Letter From FDA for Ribavirin
Capsules
Source: PRNewswire
SPRING VALLEY, N.Y.-- Par Pharmaceutical,
Inc., the principal subsidiary of Pharmaceutical Resources,
Inc. (NYSE:PRX) , today announced that its marketing partner,
Three Rivers Pharmaceuticals, has received an "approvable"
letter from the U.S. Food and Drug Administration (FDA) for
ribavirin 200 mg capsules. The FDA has completed its review
of Three Rivers' Abbreviated New Drug Application (ANDA) for
ribavirin and has concluded that the application is approvable.
Final approval is subject only to resolution of certain regulatory
issues involving final product labeling.
Ribavirin, a synthetic nucleoside analogue
with antiviral activity, is indicated for the treatment of
hepatitis C, a chronic condition suffered by approximately
4 million Americans. Ribavirin is currently marketed by Schering-Plough
Corporation under the brand name Rebetol(R). The U.S. market
for ribavirin products is approximately $600 million annually.
Three Rivers filed an ANDA containing a
paragraph IV certification with the FDA in July 2001 seeking
marketing clearance for its generic version of Rebetol(R).
Under the terms of its agreement with Three Rivers, Par has
exclusive rights to market Three Rivers' ribavirin product.
On July 16, 2003, the United States District
Court for the Central District of California granted summary
judgment of non-infringement regarding ribavirin to Three
Rivers. The district court determined that the Three Rivers'
product does not infringe any of three patents asserted by
ICN Pharmaceuticals in the litigation. Earlier, Three Rivers
reached a settlement of its patent litigation with Schering-Plough,
so this court decision resolved the remaining patent barriers
to FDA approval of Three Rivers' ANDA.
Pharmaceutical Resources, Inc., a holding
company, develops, manufactures, and distributes generic pharmaceuticals
through its wholly owned subsidiary, Par Pharmaceutical. Through
its FineTech unit, PRX also develops and utilizes synthetic
chemical processes to design and develop intermediate ingredients
used in the production of finished products for the pharmaceutical
industry. PRX currently manufactures and distributes over
170 products representing various dosage strengths of 71 drugs.
For press release and other Company information, visit http://www.parpharm.com/.
Certain statements in this press release
constitute "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of
1995. To the extent any statements made in this news release
contain information that is not historical, these statements
are essentially forward-looking and are subject to risks and
uncertainties, including the difficulty of predicting FDA
filings and approvals, acceptance and demand for new pharmaceutical
products, the impact of competitive products and pricing,
new product development and launch, reliance on key strategic
alliances, uncertainty of patent litigation filed against
us, availability of raw materials, the regulatory environment,
fluctuations in operating results and other risks and uncertainties
detailed from time to time in the Company's filings with the
Securities and Exchange Commission, such as the Company's
Form 10-K, Form 10-Q, and Form 8-K reports.
Source: Pharmaceutical Resources, Inc.
CONTACT: Stephen J. Mock, Vice President,
Corporate Affairs of Pharmaceutical Resources, Inc., +1-201-802-4000
Web site: http://www.parpharm.com/
Back to top
VA Launches New Web Site on Hepatitis
C
Source: PRNewswire
WASHINGTON-- A new, comprehensive Web site
on hepatitis C -- www.hepatitis.va.gov -- will be formally
launched Feb. 25 through a collaboration between the Department
of Veterans Affairs (VA) and the University of California
at San Francisco's Center for HIV Information (CHI).
"Hepatitis C is another reminder that veterans rely on
VA to care for a wide variety of illnesses and battlefield
injuries," said Secretary of Veterans Affairs Anthony
J. Principi. "This Web site will help both veterans and
medical practitioners to understand this complex, long-term
illness."
Hepatitis C is the most common blood borne
infection in the United States, affecting 2 percent of the
population. VA cares for more hepatitis C patients than any
other medical system, with more than 200,000 patients since
1996. The department has the largest screening, testing and
care program for hepatitis C in the nation.
The new hepatitis C Web site has a section
for veterans and non-medical employees that includes general
information and links to other Web sites. It also offers information
for health care providers that is searchable by topic and
includes best practices, guidelines and slides.
"Hepatitis C is an important public
health issue for our nation," said Dr. Lawrence Deyton,
VA's chief consultant for public health, who oversees VA's
hepatitis C programs. "VA is pleased to join with CHI,
a world-class medical Web site developer, to provide a user-friendly
resource on hepatitis C for providers, patients and public
health authorities."
CHI, based at the San Francisco VAMC, is
directed by Dr. Laurence Peiperl, a medical staff member of
both the university and the San Francisco VAMC. Dr. Paul A.
Volberding, chief of the medical service at the San Francisco
VAMC, chairs the CHI Advisory Board.
Source: U.S. Department of Veterans
Affairs
CONTACT: U.S. Department of Veterans Affairs, Office of Public
Affairs,
+1-202-273-6000
Web site: http://www.va.gov/
- http://www.hepatitis.va.gov/
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Civacir(TM)
Phase I/II Trial in Hepatitis C Liver Transplant Patients
Completed, Preliminary Results Encouraging
Source: PRNewswire
ROCKVILLE, Md.-- Nabi Biopharmaceuticals
(NASDAQ:NABI) today announced the preliminary results of its
Phase I/II trial with Civacir(TM) [Hepatitis C Immune Globulin
(Human)], an antibody-based therapy being developed to prevent
hepatitis C virus (HCV) re-infection of transplanted livers
in patients with chronic hepatitis C. The Phase I/II trial
was randomized and controlled to evaluate the safety and pharmacokinetics
(the measurement of how Civacir acts within patients) of two
dose levels of Civacir versus a control in a total of 18 patients
who underwent liver transplantation due to hepatitis C-induced
end-stage liver failure.
"The findings from this trial are
an encouraging step forward in the ongoing global battle against
hepatitis C liver disease," said Henrik S. Rasmussen,
MD, Ph.D., Nabi Biopharmaceuticals senior vice president,
clinical, medical and regulatory affairs. "This trial
demonstrated that Civacir was well-tolerated in both the high-
and low-dose treatment arms. Although the study, being a Phase
I/II study, was not powered to pick up significant differences
in effect, it was encouraging to see a trend towards a reduction
in ALT (serum alanine aminotransferase, an important liver
enzyme that measures liver function) levels. Based on these
results, we will now be able to define the continued development
strategy for this agent."
"Phase I/II trials are designed to
show that drugs are safe and they generate a measurable pharmacokinetic
effect on patients," stated Gary L. Davis, MD, director,
Division of Hematology and Medical Director, Liver Transplant
Institute, Baylor University Medical Center and lead investigator
for the Civacir trial. "We showed that Civacir is safe
and behaved as anticipated in liver transplant patients. It
was encouraging to see lower ALT levels and a trend to lower
hepatitis C viral levels in liver tissue one month after beginning
Civacir administration."
Detailed results from this study are being
prepared for submission to a peer-reviewed medical journal
and are not available at this time. This clinical trial was
sponsored by the National Institute of Allergy and Infectious
Diseases (NIAID), a part of the National Institutes of Health
(NIH), and was conducted by the NIAID Collaborative Antiviral
Study Group at four study sites in the United States.
About Hepatitis C
Hepatitis C virus (HCV) is a major cause of chronic liver
disease, including cirrhosis and liver cancer, and is the
most common cause of end- stage liver disease leading to liver
transplant in the United States. The World Health Organization
(WHO) estimates that about 170 million people, or three percent
of the world's population are chronically infected with HCV
and three to four million people are newly infected each year.
An estimated 80 percent of acutely infected individuals become
chronic carriers of HCV, a condition that can often result
in insidiously progressive liver disease. The Centers for
Disease Control and Prevention (CDC) report that approximately
five percent of people infected with HCV develop end-stage
liver failure or liver cancer and require a liver transplant
in order to survive. In North America and Europe approximately
30 - 40 percent of liver transplants are due to HCV infection.
Moreover, during surgery and in the period immediately following
transplant, these patients have no treatment options to prevent
re- infection of the transplanted liver. Re-infection of the
transplanted liver is almost inevitable within weeks to months
after surgery and can occur within days of transplantation.
HCV infection also contributes to frequent hospitalizations
and failure of the transplanted liver when it occurs in transplant
patients. Consequently, there is a significant medical need
for new and better treatment options for this patient population.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals applies its knowledge of the human
immune system to commercialize and develop products that address
serious, unmet medical needs. The company's focus is in the
areas of infectious, autoimmune and addictive diseases. In
addition to five marketed products (PhosLo(R), Nabi- HB(R),
WinRho SDF(R), Aloprim(TM), Autoplex(R) T), the company has
several products in various stages of preclinical and clinical
testing. Nabi Biopharmaceuticals has advanced StaphVAX(R)
to Phase III clinical development. StaphVAX is designed to
prevent the most dangerous and prevalent strains of Staph
aureus bacterial infections. Staph aureus bacteria are a major
cause of hospital-acquired infections and are becoming increasingly
resistant to antibiotics. The company's other products in
development include Altastaph(TM), an antibody for prevention
of Staph aureus infections, and NicVAX(TM), a nicotine vaccine,
both in Phase II clinical testing, and Civacir(TM), an antibody
for preventing hepatitis C virus re-infection in liver transplant
patients. For additional information on Nabi Biopharmaceuticals,
please visit our Web site at: www.nabi.com.
This press release contains forward-looking
statements that reflect the company's current expectations
regarding future events. Any such forward- looking statements
are not guarantees of future performance and involve significant
risks and uncertainties. Actual results may differ significantly
from those in the forward-looking statements as a result of
any number of factors, including, but not limited to, risks
relating to the possibility that our confirmatory Phase III
clinical trial for StaphVAX or our plans to commercialize
StaphVAX in the EU may not be successful; the possibility
that we may not realize the value of our acquisition of PhosLo;
the possibility that our rights to three existing biopharmaceutical
products may expire; the company's dependence upon third parties
to manufacture its products; the company's ability to utilize
the full capacity of its manufacturing facility; the impact
on sales of Nabi-HB from patient treatment protocols and the
number of liver transplants performed in HBV-positive patients;
reliance on a small number of customers; the future sales
growth prospects for the company's biopharmaceutical products;
and the company's ability to obtain regulatory approval for
its products in the U.S. or abroad or to successfully develop,
manufacture and market its products. These factors are more
fully discussed in the company's Report on Form 8-K dated
December 10, 2003 filed with the Securities and Exchange Commission.
Source: Nabi Biopharmaceuticals
CONTACT: Mark Soufleris, Vice President, Investor & Public
Relations,
Nabi Biopharmaceuticals, +1-561-989-5800
Web site: http://www.nabi.com/
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February 24th, 2004
ViroPharma
Initiates Phase 1 Hepatitis C Program With HCV-086
Source: ViroPharma Incorporated
EXTON, Pa.,(PRIMEZONE) -- ViroPharma Incorporated
(Nasdaq:VPHM) today announced the initiation of a phase 1
clinical program with HCV-086, a hepatitis C antiviral compound
that the company is co-developing with Wyeth (NYSE:WYE).
Initially, ViroPharma and Wyeth will conduct
an ascending single dose, placebo-controlled study to assess
the safety, tolerability, and pharmacokinetics of HCV-086
administered orally to healthy volunteer subjects. The study
is being conducted at a leading clinical research facility
in the United States. Should those data support further advancement
of the product, the companies plan to initiate a multiple
dose study in patients with chronic hepatitis C virus (HCV)
infection to assess the antiviral activity, safety, tolerability
and pharmacokinetic profile of HCV-086. Overall, the companies
expect to have proof of concept antiviral data from the latter
study in the fall of 2004.
"HCV-086 is a member of a new chemical
series, and our preclinical data demonstrate that it is significantly
more potent than other inhibitors that we have studied in
the past," said Dr. Stephen Villano, ViroPharma's Chief
Clinical Officer. "We also believe that HCV-086 will
have improved pharmacological attributes in humans that we
hope will translate into clinical benefit for HCV-infected
patients."
ViroPharma and Wyeth are engaged in a collaboration
to develop and commercialize antiviral compounds to treat
hepatitis C (HCV). In addition to HCV-086, the companies are
continuing to advance an additional HCV antiviral compound
through preclinical testing.
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the development and
commercialization of products that address serious diseases
treated by physician specialists and in hospital settings.
ViroPharma is currently focused on drug development activities
in viral diseases including cytomegalovirus (CMV) and hepatitis
C (HCV).
Certain statements in this press release
contain forward-looking statements that involve a number of
risks and uncertainties, including those relating to:
• ViroPharma's belief that HCV-086
will have improved pharmacological attributes in humans;
• whether HCV-086 will provide clinical benefit for
HCV-infected patients; and
• ViroPharma's plans to receive proof of concept, antiviral
data from its current phase 1 HCV studies in the fall of 2004.
Our actual results could differ materially
from those results expressed in, or implied by, these forward-looking
statements. There can be no assurance that that any of the
forward-looking statements identified in this press release
will occur. Conducting clinical trials for investigational
pharmaceutical products are subject to risks and uncertainties.
There can be no assurance that planned clinical trials can
be initiated, that planned or ongoing clinical trials can
be successfully concluded or concluded in accordance with
ViroPharma's anticipated schedule, or that HCV-086 will achieve
proof of concept. These factors, and other factors, including,
but not limited to those described in ViroPharma's most recent
annual report on Form 10-K and quarterly report on Form 10-Q
filed with the Securities and Exchange Commission, could cause
future results to differ materially from the expectations
expressed in this press release. The forward-looking statements
contained in this press release may become outdated over time.
ViroPharma does not assume any responsibility for updating
any forward-looking statements.
CONTACT:
ViroPharma Incorporated
Kori Beer, Director, Corporate Communications
(610) 321-6288
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Lamivudine
for Prevention of Chemotherapy-Induced HBV Reactivation
Source: www.gastrohep.com
Prophylactic lamivudine treatment in hepatitis
B virus carriers receiving chemotherapy prevents virus reactivation,
find doctors in the latest issue of the Journal of Viral
Hepatitis.
Hepatitis B virus (HBV) reactivation in
carriers undergoing immunosuppressive therapy is well documented.
However, the efficacy of antiviral prophylaxis
in these patients is unclear.
In this study, doctors from Turkey and
the United States assessed lamivudine prophylaxis in HBV carriers
with hemato/oncological malignancies, who received chemotherapy.
The team evaluated 18 HBV carriers with
malignancy. Of these, 8 patients were enrolled for prophylactic
lamivudine therapy. The remaining 10 controls did not receive
prophylactic therapy.
The team began lamivudine treatment on the same day as the
patient received chemotherapy. Lamivudine was maintained for
a year after chemotherapy was discontinued.
The team did not find any HBV-related mortality
in either group. 50% of the control group experienced HBV
reactivation.
They identified no evidence of HBV reactivation
in the lamivudine group. However, 50% of the control group
experienced a reactivation of HBV infection.
The reactivation occurred during chemotherapy
in 4 patients.
No lamivudine-related major adverse effects
were observed.
Dr Idilman's team concluded, "Prophylactic
lamivudine treatment in HBV carriers with hemato/oncological
malignancy receiving chemotherapy prevents chemotherapy-induced
HBV reactivation".
J Viral Hepatitis 2004; 11(2): 141-7
Back to top
Bad Blood
Lingers Over Jail Donors
By Gerard Ryle
The Australian Red Cross collected blood
from prisoners for more than a decade after some other countries
declared the practice unsafe, a Senate inquiry into hepatitis
C has been told.
Canada banned blood collection in prisons
in the 1970s because it was "too dangerous", a victims
group has claimed.
But until 1983 in Victoria and Tasmania,
mobile blood collection units were sent to prisons to collect
blood from inmates.
According to the Red Cross, collections
from NSW prisons ceased in the mid-1970s and in South Australia
in 1975. No specific date, other than the early 1980s, was
given for when they stopped in Western Australia.
The Red Cross said it was "now intending
to respond to this fully during the inquiry process in relation
to the historical context of the decision-making at the time".
In its submission to the inquiry, it admits
it has no way of knowing how many Australians have been infected
through blood or blood products. It estimates there may be
about 3400 people infected who are still alive.
"To put these figures into context,
in the past 20 years blood services in Australia have issued
in excess of 30 million blood products," the submission
says.
The Tainted Blood Product Action Group,
which campaigned for the inquiry, says collecting blood from
prisoners was inconsistent with a voluntary blood donation
system that relied on the honesty of donors.
"Scientific and medical knowledge in the 1970s was advanced
enough to understand the threat of hepatitis and the increased
dangers of encouraging and accepting blood . . . from prison
inmates," its submission says.
The group said thousands of Australian
hospital patients have been infected with hepatitis C through
blood products.
The Medical Error Action Group, a victims
support group, has told the inquiry that tainted blood "represents
one of the worst medical disasters" in Australian history.
This story was found at: http://www.smh.com.au/articles/2004/
02/23/1077497517470.html
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February 25th, 2004
Do-It-Yourself
Tattoos Worry Officials
Martha Irvine, AP National Writer
Source: Seattle Post-Intelligencer
MINNEAPOLIS -- Erik Hansen rolls up his
left sleeve to reveal a roughly drawn skull-and-crossbones-tattoo.
A friend did it for him a few weeks ago, using a needle and
ink at what Hansen calls a "poke and stick party"
- a growing trend among young people as tattoos and piercings
have surged in popularity. Body art between friends can be
a rite of passage, a backroom ritual often done on the sly.
Teens talk about school athletes doing tattoos or piercings
for one another as an initiation. "It's more fun to have
a friend do it - and it was free," says Hansen, a 20-year-old
from Minneapolis. But officials where he lives - and in other
places nationwide - are worried.
In Hennepin County, which includes Minneapolis,
they've started a poster campaign in schools and neighborhood
hangouts to encourage young people to have their tattoos and
piercings done by licensed professionals. "Get the good
design, not a bad disease!" says one poster about tattooing.
Another features a photo of an upper lip piercing with warnings
about the risk of infections, blood-borne diseases and nerve
damage.
The Oregon Health Licensing Office has
a similar Web-based campaign, begun after several young people
from the town of Klamath Falls got serious upper ear infections
from piercings done at a jewelry kiosk with lax sterilization
procedures. The cases - and resulting disfiguration - were
documented in Wednesday's Journal of the American Medical
Association.
Meanwhile, the Texas Department of Health
library offers a video for teens and young adults titled "Tattooing
and Body Piercing: Thinking Smart About Body Art." And
Connecticut is among states with a brochure that has similar
information. The biggest concerns include the potential spread
of tetanus and hepatitis B or C if people share tattooing
needles or whatever sharp objects - pins and nails included
- they use to do their piercing. "It's just not something
you can do in your garage," says Shahn Anderson, a licensed
tattooist and president of the Alliance of Professional Tattooists,
who helped design the Hennepin County campaign. Eighteen-year-old
Katie Klaren thinks posting the information is a good idea.
"Anything but ears, I would want a professional to do,"
the high school senior from Roseville, Minn., says as she
waits at a licensed piercing studio in Minneapolis with her
friend, Leslie Barker. The fresh-faced teens were there to
have their nipples pierced - a procedure that's become trendy
since Janet Jackson's Super Bowl flash. "It's an on-the-edge
kind of thing," Barker says, adding that both waited
until they didn't have to have written parental permission
- required in Hennepin County since last summer. Several states
have laws that prohibit minors from getting tattoos or "body
art" regardless of who's holding the needle. And others,
such as Wyoming, are considering bans.
Often, licensed piercers and tattooists
have even stricter standards than states or cities, requiring
a parent to be present or, in some cases, setting their own
age limits for certain procedures. Some youth think that banning
them from having work done, or requiring parental permission,
is only causing more minors to do the piercing themselves
or seek out unlicensed amateurs, known in the industry as
"scratchers." "You can't just outlaw things,"
says Hansen, who says he could not have afforded a professional
tattoo even if he'd wanted one. "It's like prohibition;
it doesn't work." Gail Dorfman - the Hennepin County
commissioner whose age-limits ordinance prompted the safety
campaign - disagrees. "We're not telling kids they shouldn't
get tattoos or piercings," says Dorfman, who's also the
mother of five teenagers. "We're just saying, 'Be smart
about it.'" She says doctors and nurses at the county's
hospital have seen a spike in young people with infections
caused by amateur work, sometimes done by friends or unlicensed
operators. She also notes the case of a 19-year-old woman
who pleaded guilty to a misdemeanor for doing piercings in
a vehicle near a Minneapolis high school and another in suburban
Wayzata last year.
Jesika Bornsen, a professional piercer
at a shop called Saint Sabrina's in Minneapolis, agrees that
the campaign can only help educate teens and parents. "It's
saying, 'Talk to your parents about it,'" says Bornsen,
a member of Association of Professional Piercers who's worked
in the field for eight years. She says parents also might
be pleasantly surprised if they checked out licensed piercing
and tattoo facilities, which increasingly look more like spas
than darkened back rooms. In the end, she says, "Parents
have to pick their battles." "Do you want your kid
to have a healthy piercing?" she asks. "Or the safety
pin in their eyebrow?"
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Peginterferon
Alpha 2a versus Interferon Alpha 2b Plus Ribavirin in Chronic
Hepatitis C
Source: www.gastrohep.com
Treatment with peginterferon alpha 2a minimizes
the adverse impact of therapy on health-related quality of
life in patients with chronic hepatitis C, find physicians
in the Journal of Viral Hepatitis.
In this study, physicians from the United
States assessed the effect of 2 interferon-based therapies
on the health-related QOL, work productivity and resource
utilization in patients with chronic hepatitis C.
The team randomized 412 patients to either
peginterferon alpha (pegIFN) 2a mono-therapy (n = 206) or
interferon alpha (IFN) 2b plus ribavirin (RBV) (n = 206).
The team administered the PegIFN 2a subcutaneously
at a dose of 180 g once weekly for 48 weeks. The IFN 2b/RBV
was administered at doses of 3 MU thrice weekly subcutaneously
and 1000-1200 mg/day orally.
The physicians used the SF-36 Health Survey
Questionnaire and additional generic and specific scales to
evaluate the patients.
They found that the IFN 2b/RBV patients
score less well for all SF-36 summary and Hepatitis Quality
of Life Questionnaire (HQLQ)-specific scales than the pegIFN
2a group. These differences were pronounced during the first
24 weeks of treatment.
The pegIFN group also scored better on
all measures of work functioning and productivity at each
visit.
Dr Perrillo's team concluded that, "Treatment
with pegIFN 2a relative to IFN 2b/RBV minimizes the adverse
impact of therapy on health-related QOL".
"Patients randomized to pegIFN 2a
had improved work productivity, less activity impairment,
decreased need for prescription drugs to treat adverse effects,
and better adherence to therapy".
J Viral Hepatitis 2004; 11(2): 157-65
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Schering-Plough,
Continuing Cost Cuts, Lays Off 200
Linda A. Johnson
Source: Assoicated Press
TRENTON, N.J. (AP) --Drug maker Schering-Plough Corp., struggling
to turn around amid plunging revenues and mounting losses,
is laying off 200 U.S. workers and freezing hiring under its
ongoing plan to slash payroll costs. The layoffs come after
only 900 U.S. employees, including 600 in New Jersey, signed
up for the Kenilworth-based company's voluntary early retirement
package late last year. "We are temporarily suspending
hiring worldwide for the next several months," company
spokeswoman Rosemarie Yancosek said Wednesday.
Schering-Plough, which makes allergy and
hepatitis C medications, announced a restructuring, including
the voluntary retirement plan and suspension of executive
bonuses, last August. In December, executives said they planned
to reduce by at least 10 percent all payroll expenses, including
employee salaries and benefits and costs for contractors,
temporary workers and consultants.
"We're definitely getting there,"
said Yancosek, who would not specify what percentage of the
job cuts have been completed.
She said Schering-Plough already has cut
about 200 positions outside the United States, including 170
at an Irish manufacturing plant that makes the company's top
seller, Peg-Intron for hepatitis C.
The new layoffs include 110 workers in
New Jersey, mostly at company headquarters in Kenilworth and
a manufacturing and office site in nearby Union; a handful
are at company locations in Berkeley Heights, Cranford, Lafayette,
Madison and Springfield, Union County. Another 90 workers
in other states also are getting pink slips.
"The vast majority were notified last
week,'' Yancosek said. Neither the job cuts nor the hiring
freeze affect some key job categories: the sales force or
production workers and staff working on manufacturing plant
upgrades ordered by the Food and Drug Administration because
of long-standing deficiencies.
Increased competition in the hepatitis
C market, loss of most of allergy medicine Claritin's $3 billion
in annual revenues due to generic and nonprescription competitors
and a scarcity of promising new drugs have added to chief
executive officer Fred Hassan's problems. Since the turnaround
whiz took over last April, Schering-Plough has posted losses
in the last two quarters, the first in the company's 34 years.
Schering-Plough shares were down 16 cents
at $17.94 in afternoon trading on the New York Stock Exchange.
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February 26th, 2004
Schering-Plough
Sees Tax Refund Over $400M In '04
Source: Dow Jones
WASHINGTON --Schering-Plough Corp. (SGP)
expects to receive a tax refund of more than $400 million
in 2004.
The Kenilworth, N.J., drug company said
it had $600 million of cash available in the U.S. as of Dec.
31 to pay down commercial paper balances or fund its U.S.
operations, according to its annual report filed with the
Securities and Exchange Commission.
In 2003, the company's U.S. operations
generated tax losses, primarily due to the decline in sales
of its Claritin product and the continued investment in research
and development, the filing said. For 2003, all of the company's
U.S. tax losses will be used to recoup taxes paid in previous
years as a carryback benefit, the filing said.
The company said it also expects its U.S.
operations will generate tax losses in 2004, but only some
of the losses are expected to be used to recoup taxes paid
in previous years. The amount of the expected 2004 loss that
is more than what is used to recoup taxes paid in previous
years becomes available to reduce taxable income in the future,
according to the filing.
Schering-Plough said its U.S. operations
have a deficit of $1.4 billion, but it anticipates that to
decline in 2004.
For 2004, the company expects its foreign
operations to generate cash and its U.S. operations to have
cash needs.
If the company's current cash management
strategy and capital structure remain unchanged beyond 2004,
Schering-Plough said, it expects both the cash held by the
foreign-based subsidiaries and the debt owed by the U.S.-based
subsidiaries to increase.
The company said it is evaluating whether
the present strategies and structure are the most appropriate
in light of the increasing debt levels and the changing portfolio
of the company's products.
Schering-Plough said it believes it has
sufficient financial resources to meet all of its financial
needs. The company's non-U.S. subsidiaries hold more than
$4 billion in cash and cash equivalents and short-term investments,
the filing said.
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Schering-Plough
CEO Urges Drug-Subsidy Foundation
Ransdell Pierson
Source: Reuters
NEW YORK - The chief executive of Schering-Plough
Corp. on Thursday called for creation of an independent U.S.
foundation through which drugmakers could together offer free
or cut-rate medicines to the uninsured, without raising antitrust
concerns.
Fred Hassan, who took the helm of the Kenilworth,
New Jersey-based drugmaker last year, outlined his plan in
a speech to the National Medicare Prescription Drug Congress
in Washington.
Hassan said recently enacted Medicare reforms
should double to 40 million the number of senior citizens
and disabled whose drugs will at least partially be reimbursed
by the federal insurance program. Another 175 million Americans
are covered by employer-based insurance programs.
Although 43 million Americans have no insurance,
those with sufficiently low incomes are eligible for a crazy
quilt of different assistance programs offered by major drugmakers.
But Hassan said only 6 million uninsured
patients took advantage of those industry programs last year,
largely because of difficulty applying for multiple programs
and sorting out differences among them.
"Currently, each company must run
its own separate program, each with its own eligibility, application
procedures, renewal requirements and restrictions,'' Hassan
said.
He said individual drugmakers would like
to band together and offer a more-uniform and accessible program
but are barred from doing so by antitrust laws, which are
designed to prevent price-fixing and other forms of collusion
among rival companies.
He called for creation of an independent
National Charitable Medicines Foundation that would work with
participating drugmakers to create a "single point of
entry and eligibility'' for all company patient assistance
programs for the uninsured.
“It would do so, without raising
antitrust concerns,” he said.
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February 27th, 2004
Hepatitis
Drug-Maker Complaints Reviewed Federal Health Officials Review
Complaints That Hepatitis Drug-Maker Chiron Blocks Research
Source: The Associated Press
SAN FRANCISCO—Industry scientists
have complained for years that Chiron Corp. has hindered the
fight against hepatitis by creating a virtual commercial monopoly
over drug research. Now, federal health officials are reviewing
the 14-year-old government agreement that gave Chiron so much
control over research that seeks to help the 170 million people
afflicted with the disease.
Chiron holds 100 patents in 20 countries
related to hepatitis C. Competitors complain they've abandoned
plans to enter the field because Chiron demands too much money
to access its technology. Chiron has successfully sued many
companies for infringing its patents related to the virus.
Those patents credit Chiron scientists
with discovering the hepatitis C virus despite the fact that
a scientist from the Centers for Disease Control and Prevention
contributed much to the original research.
But the CDC signed away to Chiron most
of the commercial control of the virus for a little more than
$2.2 million in 1990.
"There have been a number of individuals
in the scientific community that are involved in the prevention,
treatment and research of hepatitis C that have said the agreement
is having an impact on the scientists' ability to address
hepatitis C," said CDC spokesman Tom Skinner. "We
are looking into whether or not the agreement we have in place
with Chiron is having an impact and, if so, what kind of impact."
Skinner couldn't provide any names of complaining
scientists, details of what was being reviewed or what projects
may be affected. He said he was unsure if the CDC's inquiry
would ever expand beyond informal discussions.
Skinner's not even sure what recourse the
CDC may have 14 years after signing the contact and said other
CDC officials weren't available to comment.
What's more, many companies involved in
hepatitis C research are reluctant to publicly discuss Chiron's
tactics. Most have been sued at one time or another by Chiron,
and several have settled their lawsuits in recent months and
say they just want to get on with the research.
Still, the CDC concern highlight the ongoing
tension between the U.S. patent system and free scientific
inquiry.
The CDC inquiry also illustrates how sophisticated
the government and universities have become in the last decade
with intellectual property originating in their labs.
The CDC, for instance, claims ownership
of the SARS virus and its entire genetic content after its
researchers helped map the bug's genome. Rather than try to
profit from it, the CDC wants to prevent others from monopolizing
the field the way Chiron does with hepatitis C.
"The intellectual property was pretty
new and at that time everybody was learning how to deal with
it," said former CDC official Walter Dowdle, one of three
government officials to sign the Chiron deal. "This was
very early in the intellectual property business between companies
and government."
Though academic scientists say they've
encountered few problems working with the company, they still
can't turn their discoveries into drugs without industry help.
Chiron said the CDC hasn't notified it of any review and defended
its handling of its patents. Spokesman John Gallagher said
the Emeryville- based company has deals with 13 competitors
that allow them to pursue hepatitis C drugs with Chiron's
patented technology.
Gallagher said Chiron makes its technology
freely available to nonprofit research scientists, many of
whom credit the company with funding hepatitis C science meetings
and supporting academic endeavors.
"I would challenge anyone to show
us anyone who has done as much as Chiron has," Gallagher
said.
Hepatitis C is a blood-borne virus, often
contacted by sharing needles, and can lead to chronic liver
disease and liver cancer. Disease rates have fallen in the
United States but are on the rise in developing nations.
Chiron's scientists in 1987 developed a
technique to clone multiple versions of the elusive hepatitis
C virus, which allows researchers to easily generate billions
of viruses to research. Chiron received a patent for the discovery
three years later.
The CDC filed a competing patent application,
listing government scientist Dan Bradley as a co-discoverer.
But in 1990, the government and Bradley withdrew their claims
as co-inventors and renounced all rights after Chiron paid
the CDC $1.9 million and Bradley $337,500.
In 1994, Bradley unsuccessfully sued Chiron
in an attempt to undo the deal. He dropped his quest after
losing a federal appeal four years later. Bradley, who has
left the CDC, couldn't be reached through his lawyer.
"I have always thought Dan Bradley
got a raw deal by being excluded from the patent," Scripps
Research Institute researcher Dr. Frank Chisari said in an
e-mail interview. "That dispute was settled a long time
ago after a great deal of pressure by Chiron lawyers."
While Chisari said he had no problems
personally with Chiron, he added: "I believed then and
I believe now that Chiron scientists wouldn't have cloned
the viral genome when they did if Dan Bradley and his colleagues
at the CDC hadn't provided them with meticulously pedigreed
material containing the genome."
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