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Week Ending: January 15th, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• Researcher Cites "Bias" Toward
Peg-Intron in Trial
• Idenix Reports Interim Analysis of a
Phase IIa Clinical Trial of Valopicitabine (NM283) in Combination
with Pegylated Interferon in Treatment- Naive Hepatitis C
Genotype 1 Patients
• Isis Pharmaceuticals to Slash Work Force
• Gloucester Reaches Out to Those with
Hepatitis C
• No Advantage of Combination Therapy for
Chronic Hep B
• Interferon Slows Hep C Progression: Research
Confirms Low-Dose Therapy Works for Long-Term Maintenance
• 10% of Babies Infected with HCV Via Moms
• Drug Firms Offer
Saving Card for U.S. Uninsured
• Health Dept Requests BTSB Report
• Hersh & Hersh Files Lawsuit Against
Drug Maker Valeant for Brain Injury Sustained by Plaintiff
During Hepatitis C Clinical Drug Trial
• Chronic Hepatitis B and C: Chronic Lack
of Effective Treatment
• Obliteration of Portal-Systemic Shunts
Benefits Patients
• Hepatitis C Caring Ambassadors Program
Releases New, 3rd Edition of Hepatitis C Choices
• Hepatitis Victim Wins Cash Ruling
• Update from Cardinal Health Regarding
Baltimore-Area Hepatitis C Investigation
• Experts Warn against Growth Of Hepatitis
C on LI
• Depression Caused by Common Treatment
for Hepatitis C May Affect Outcome
January 7th, 2005
Researcher
Cites "Bias" Toward Peg-Intron in Trial
http://us.rd.yahoo.com/finance
By Ransdell Pierson
NEW YORK, Jan 7 (Reuters) - A lead researcher for a high-stakes
trial comparing the world's top-selling drugs for hepatitis
C said the study's design could "bias" results in
favor of Schering-Plough Corp.'s product.
"Unfortunately life is not
perfect and this study is not perfect as well," Dr. John
McHutchison, co-lead investigator of the Schering-Plough (SGP.N:
Quote, Profile, Research) trial, told Reuters in an interview
on Thursday.
Schering-Plough's Peg-Intron and Roche
Holding AG's (ROG.VX: Quote, Profile, Research) more popular
rival medicine, Pegasys, are both injectable forms of interferon.
They are used in 48-week treatments with a pill called ribavirin
that helps them eradicate the hepatitis C virus, the biggest
cause of liver transplants.
McHutchison, a Duke University researcher,
said the study's design will probably allow more patients
receiving Peg-Intron to stay on stronger doses of ribavirin
than those taking Pegasys.
"Maintaining the (highest tolerable)
dose of ribavirin, regardless of which interferon is used,
is very important for controlling the virus, particularly
in the early part of treatment," McHutchison said.
Schering-Plough in May launched the 2,880-patient
U.S. trial, called IDEAL, and hopes to unveil results in 2007
that will prove Peg-Intron is superior.
Should it triumph, Schering-Plough aims
to use the data as a marketing weapon to stem lagging sales
of its one-time blockbuster, and help the struggling drugmaker
regain earnings growth.
Peg-Intron and Schering-Plough's brand
of ribavirin had combined third-quarter sales of $184 million,
a fraction of the $703 million they boasted in the same quarter
of 2002.
McHutchison said Peg-Intron patients will
take starting ribavirin doses of 800 milligrams to 1400 milligrams
daily, vs 1,000 to 1,200 milligrams for Pegasys patients.
But Peg-Intron patients who develop anemia
or other side effects from ribavirin will have their daily
dose of the pill reduced by 200 milligrams, with subsequent
200-milligram cuts if necessary.
By contrast, Pegasys patients with side
effects must have their ribavirin cut back to 600 milligrams
in one fell swoop.
"The dose reductions for ribavirin
are not equivalent in the two arms of the study and could
therefore introduce a potential bias" in favor of the
Peg-Intron arm of the trial, McHutchison said.
McHutchison said he expressed his concerns
to Schering-Plough, which in turn relayed them to the U.S.
Food and Drug Administration before the trial began.
However, the FDA insisted that instructions
on the Pegasys drug label be followed -- any ribavirin reductions
must be to 600 milligrams.
"The FDA wouldn't allow it
(smaller cutbacks), and unfortunately that's the way it stands,"
McHutchison said.
However, McHutchison said most doctors
typically reduce ribavirin among Pegasys patients by 200 milligram
increments.
Despite the potential ribavirin dose advantage
to Peg-Intron patients, McHutchison and Schering-Plough said
the study is large enough to demonstrate the true superiority
of either medicine.
The new trial began two years after Roche
launched Pegasys in the United States and ended Peg-Intron's
monopoly for treating the often-fatal disease. An estimated
4 million Americans are believed to be infected by the virus.
Pegasys has leapfrogged Peg-Intron in
sales largely due to its greater convenience. All patients
receive the same injectable dose, whereas Peg-Intron is given
according to body weight.
Pegasys and Roche's own brand of ribavirin
command a 62 percent share of the U.S. market, according to
Verispan LLC, which tracks drug sales for health-care companies.
Back to top
January 10th, 2005
Idenix
Reports Interim Analysis of a Phase IIa Clinical Trial of
Valopicitabine (NM283) in Combination with Pegylated Interferon
in Treatment- Naive Hepatitis C Genotype 1 Patients
SourceURL:http://biz.yahoo.com
Press Release Source: Idenix Pharmaceuticals, Inc.
Patients receiving the combination
treatment achieved a mean viral load reduction of 3.2 log10,
or 99.94 percent, after 12 weeks of treatment
SAN FRANCISCO, Calif., Jan. 10 /PRNewswire-FirstCall/
-- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX - News), a biopharmaceutical
company engaged in the discovery and development of drugs
for the treatment of human viral and other infectious diseases,
today announced interim clinical trial data for valopicitabine
(NM283), the company's lead drug candidate for the treatment
of hepatitis C. In this phase IIa trial, patients are randomized
to one of two treatment arms, valopicitabine (NM283) monotherapy,
or valopicitabine (NM283) plus pegylated interferon. This
interim data analysis includes all 19 patients who have completed
12 weeks of treatment in this trial. The patients receiving
the combination of NM283 and pegylated interferon achieved
a mean reduction of serum HCV RNA of 3.2 log10, or 99.94 percent,
at week 12. These data will be included in the company's presentation
at the JPMorgan Healthcare Conference on Wednesday, January
12, 2005 at 8:30 a.m. in San Francisco.
"In patients infected with
HCV genotype 1 -- a difficult-to-treat strain of hepatitis
C virus and the most prevalent strain in the U.S., Western
Europe and Japan -- virologic response to the current standard
therapy of ribavirin and interferon is inconsistent,"
commented Nathaniel Brown, M.D., Idenix's executive vice president,
clinical development and chief medical officer. "However,
the consistency of response to the combination of valopicitabine
and interferon appears promising: eleven of twelve patients
receiving this combination treatment had significant HCV RNA
reductions of 1.7 to 6.2 log10 by week 12. Based on these
encouraging interim data, we have extended this phase IIa
trial to 6 months in order to investigate longer duration
treatment."
Phase IIa Trial Design and 12 Week Interim
Results: Idenix will enroll a total of 30 patients in the
phase IIa clinical trial, which is designed to assess the
safety, antiviral activity and pharmacokinetics of the combination
of NM283 and pegylated interferon compared to NM283 alone.
Key entry criteria for this clinical trial include treatment-naive
patients with HCV genotype 1, baseline viral load greater
than 5 log10 copies/ml and alanine aminotransferase (ALT)
levels less than 5 times the upper limit of normal. In this
phase IIa clinical trial, patients are being randomized to
one of two treatment arms so that 12 patients will receive
NM283 monotherapy and 18 patients will receive NM283 plus
pegylated interferon.
After 12 weeks of treatment, mean HCV
RNA reductions from baseline were 0.9 log10 IU/mL, or 87.4
percent, for the 7 patients in the NM283 monotherapy group,
and 3.2 log10 IU/mL, or 99.94 percent, for the 12 patients
in the combination treatment group. Nine of twelve patients
receiving combination treatment have achieved an early viral
response with a greater than 2 log10 decrease in levels of
HCV RNA at week 12. Tolerance of both treatment regimens has
been satisfactory to date, with no serious adverse events.
Four- week data from these same 19 patients were presented
by Dr. Nezam Afdhal at the American Association for the Study
of Liver Diseases' annual meeting in November 2004.
Hepatitis C Development Program
Idenix's hepatitis C development program is initially
seeking to address the large patient population that has failed
to respond to the current standard treatment, pegylated interferon
plus ribavirin, and for whom no other treatment option is
currently available. Idenix expects to subsequently target
the treatment-naive patient population for whom treatment
with the current standard of care is only successful in approximately
50% of patients.
"Hepatitis C patients confront
many unmet treatment needs, with several hundred thousand
having failed prior treatment with no therapeutic options,
and millions of people infected with difficult to treat strains
of HCV," said Jean-Pierre Sommadossi, Ph.D., Idenix's
chairman and chief executive officer. "Idenix is committed
to rapidly advancing the NM283 clinical program, which seeks
to address the medical needs of all individuals infected with
hepatitis C."
Development for Treatment-failure Patients:
Idenix has initiated a phase IIb clinical trial for NM283
in patients who have previously failed treatment with pegylated-interferon
and ribavirin and expects to begin enrolling patients in this
study in early 2005. The company anticipates that this 6-
month head-to-head trial, comparing the combination of NM283
plus pegylated interferon to the current standard therapy
(ribavirin plus pegylated interferon), will enroll approximately
170 HCV genotype 1 patients who have previously failed at
least 3 months of treatment with current standard therapy.
This phase IIb clinical trial will also include a monotherapy
arm of NM283.
Development for Treatment-naive Patients:
Encouraging results from the ongoing phase IIa clinical
trial, summarized above, will support initiation of a larger
phase IIb clinical trial of valopicitabine (NM283) in combination
with pegylated interferon in treatment-naove patients, the
majority of whom are expected to be infected with HCV genotype
1. Idenix anticipates beginning this trial in mid-2005.
About Valopicitabine (NM283)
Valopicitabine (NM283) is an oral, novel nucleoside analog
that was co- discovered by Idenix and the University of Cagliari
through a cooperative laboratory agreement under the direction
of Dr. Paolo LaColla, Director of the Department of Biomedical
Sciences and Technologies of the University. Valopicitabine
(NM283) is being developed in combination with pegylated interferon.
To date, valopicitabine (NM283) has demonstrated a satisfactory
safety profile with mild to moderate gastrointestinal side
effects and no treatment-related discontinuations.
About Hepatitis C
There are approximately 170 million people worldwide with
chronic HCV infection, of which approximately 2.7 million
are in the United States. Chronic HCV infection accounts for
40 percent of end-stage cirrhosis, 60 percent of liver cancer
and 30 to 40 percent of liver transplants in the United States
and other industrialized countries. Responses to current treatment
options are frequently inadequate due to the inability of
some patients to tolerate these treatments and by their limited
effectiveness, particularly in patients infected with HCV
genotype 1. The genotype 1 strain of HCV is the most treatment-resistant
HCV genotype and is estimated to cause more than 70 percent
of the reported cases of hepatitis C in the U.S. and Japan,
and more than 65% of the reported cases of hepatitis C in
Western Europe.
About Idenix
Idenix Pharmaceuticals, Inc. is a biopharmaceutical company
engaged in the discovery and development of drugs for the
treatment of human viral and other infectious diseases. Idenix's
current focus is on the treatment of infections caused by
hepatitis B virus, hepatitis C virus and human immunodeficiency
virus (HIV). Idenix's headquarters are located in Cambridge,
Massachusetts and it has drug discovery operations in Montpellier,
France and Cagliari, Italy. For further information about
Idenix, please refer to http://www.idenix.com.
Forward-looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Act
of 1995. Statements in this press release other than those
that are historical in nature are "forward- looking statements."
Such forward looking statements, which include statements
with respect to the potential therapeutic benefits and successful
development of the company's drug candidates and the company's
drug discovery, research and clinical development activities,
are subject to numerous factors, risks and uncertainties that
may cause actual events or results to differ materially from
the company's current expectations. These risks and uncertainties
relate to the results of clinical trials and other studies
with respect to the drug candidates that the company has under
development; the timing and success of submission, acceptance
and approval of regulatory filings; the company's dependence
on its collaboration with Novartis Pharma AG; the company's
ability to obtain additional funding required to conduct its
research, development and commercialization activities; the
ability of the company to attract and retain qualified personnel,
and the company's ability to obtain, maintain and enforce
patent and other intellectual property protection for its
drug candidates and its discoveries. These and other risks
are described in greater detail in the "Risk Factors"
section of the company's quarterly report on Form 10-Q for
the quarter ended September 30, 2004 and filed with the Securities
and Exchange Commission and other filings that the company
makes with the Securities and Exchange Commission.
All forward-looking statements reflect
the company's expectations only as of the date of this release
and should not be relied upon as reflecting the company's
views, expectations or beliefs at any date subsequent to the
date of this release. Idenix anticipates that subsequent events
and developments may cause these views, expectations and beliefs
to change. However, while Idenix may elect to update these
forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so.
Idenix Pharmaceuticals' Contacts
617-995-9831
Media: Teri Dahlman
Investors: Amy Sullivan
Source: Idenix Pharmaceuticals, Inc.
Back to top
Isis
Pharmaceuticals to Slash Work Force
SourceURL:http://biz.yahoo.com/
Associated Press
Isis Pharmaceuticals to Slash Work
Force, Focus on Developing Key Drug Candidates
CARLSBAD, Calif. (AP) -- Isis Pharmaceuticals
Inc. said Monday it will reduce its work force by about 40
percent as part of a plan to focus resources on developing
key antisense drug candidates and narrow operating losses.
The company said it aims to develop and
commercialize its alicaforsen enema treatment for ulcerative
colitis and advance its pipeline of second-generation antisense
drugs aimed at treating high cholesterol and type 2 diabetes,
as well as cancer drugs being developed in partnership with
other companies.
Isis said it will record write-downs,
mostly in the fourth quarter, of about $30 million to $40
million of tangible and intangible assets, such as equipment
and patents, "in areas that are non essential to our
current focus." Isis said it will halt development of
its ISIS 14803 drug for hepatitis C and ISIS 104838 treatment
for rheumatoid arthritis.
Before these charges, the company said
it is on target to meet its goal of an operating loss in the
mid-$80 million range, excluding expenses for non-cash compensation.
Isis said additional charges related to nonessential assets
will be incurred in the first quarter of 2005.
Analysts surveyed by Thomson First Call
are expecting Isis to post losses of 45 cents per share for
the quarter and $1.92 per share for 2004.
Back to top
Gloucester
Reaches Out to Those with Hepatitis C
SourceURL:http://www.ecnnews.com
By Elizabeth Eddy
It's the most prevalent communicable disease
in Gloucester [Mass], with more than 500 cases registered
in the last 10 years. And many other people may be living
with this disease without knowing it.
Spread by contact with blood, hepatitis
C is a serious liver ailment that can remain undetected in
the body for as long as two decades, according to Sunny Robinson,
public health nurse for the Gloucester Health Department.
"One of the central problems with hepatitis C is that
it may leave a person without symptoms for many years, so
early recognition is really important."
"Hepatitis C can remain silent
for even 20 to 25 years before symptoms appear, and since
many people don't know they have it, they are not making healthy
choices now to protect themselves," said Susan Oleksiw,
executive director of the North Shore AIDS Health Project.
"Because hep C can be present in the body many years
before it becomes evident, people can miss a real window of
opportunity for treatment."
Reaching out to those who may unknowingly
have this disease is a public health goal, Robinson said.
"We want people who are at risk to recognize their risk
and get tested."
Testing for the illness is a cornerstone
of good health, Oleksiw added, since many people may have
been exposed to this virus via blood transfusions or organ
transplantation before 1992, when screening for hepatitis
C was instituted. Furthermore, some who received a blood transfusion
or other such product during that period were not informed
of it, so they may not realize they are at risk.
Fortunately, this type of medical treatment
"is no longer a source of infection in this country as
these (products) are now tested for hep C," Robinson
said.
The main route of infection these days,
she continued, is intravenous drug use. This behavior also
can spread HIV. There is also some occupational risk of contracting
hepatitis C through blood exposure for those who work in the
health care, military or correctional fields. Any setting
where blood is present could also pose a risk, such as an
unprofessional tattoo parlor or manicuring station, for example.
These professions are regulated and should conform to public
health standards.
Casual contact does not spread hepatitis
C; it is only carried by blood. It is sometimes transmitted
by sexual contact, especially if the person has multiple partners,
and if any of these people are drug users.
However, people in monogamous relationships
are at low risk, Robinson said.
Educating the local public about hepatitis
C became easier two years ago when the Gloucester Health Department
received a grant from the National Association of City and
County Health Officers. The department was then able to offer
an informational campaign to health and human services agencies,
Robinson said.
And last year, the Health Department and
the North Shore AIDS Health Project collaborated to create
a one-day-a-week support program for people with hepatitis
C. This program, free to participants because of grant money
from Roche Pharmaceuticals, offers clients the same support
model that the AIDS project developed for those with HIV and
AIDS. The project also hopes to expand services with money
from a new federal grant secured through the efforts of Congressman
John Tierney.
The AIDS project recently expanded its
holistic therapies to those with hepatitis C. The drop-in
program is available Mondays from 9 a.m. to 4 p.m. Visitors
can meet with a nurse educator, take advantage of case management
services and advocacy, enjoy a congregate meal and, by appointment,
receive holistic services such as acupuncture and massage.
"In addition, hep C-positive
people offer each other lots of informal support and advice
about how to live well or for dealing with treatment side
effects," Robinson said. "Vaccinations against hepatitis
A and B, strongly recommended for persons with hep C, are
new services that will be added immediately in the new year."
The project is also considering whether
to expand or change hours of service, whether to add more
outreach and prevention efforts, adding testing, reinstituting
a formal support group, and if the service area should be
expanded, according to Robinson.
"It is a warm and caring place
where you can raise concerns about any of your needs and have
someone help you figure them out. Wherever you are in the
continuum of treatment, the project is there to help you,"
Robinson said.
Caring for the mind as well as the body
is an essential part of managing this illness, Robinson said.
"Treatment can be arduous and difficult," she said,
"so you must keep your liver healthy." This involves
the "triumvirate of eating well, living healthily, and
good stress management."
"The quality of food, rest,
exercise and stress management are absolutely central and
absolutely worthwhile for coping with hepatitis C," she
continued. For example, healthy living for those with hepatitis
C includes not drinking alcohol. "The use of alcohol
allows hepatitis C to damage the liver more quickly."
And since the liver metabolizes all medications,
hepatitis C patients "should use acetaminophen (Tylenol,
etc.) in very moderate amounts. It's a very safe drug except
in cases of liver damage."
For more on hepatitis C and services available
to those with the illness, contact the AIDS project at (978)
283-0101 or the Gloucester Health Department at (978) 281-9771.
This article is part of a weekly educational
series provided by the Gloucester Health Department and Addison
Gilbert Hospital.
Back to top
No
Advantage of Combination Therapy for Chronic Hep B
SourceURL:http://www.gastrohep.com
Pegylated interferon alpha-2b is effective
and well tolerated for chronic hepatitis B. Rates of sustained
viral clearance and reduction of viral load are as high as
or higher than those that have previously been reported for
any other therapy
Results of an international study in this
week’s issue of The Lancet suggest that pegylated
interferon alpha offers the best treatment option for people
with chronic hepatitis B infection.
Patients successfully treated for chronic
hepatitis B are less likely to develop cirrhosis, liver failure,
and liver cancer.
Previous research has suggested that treatment—either
with standard interferon a or nucleoside analogues—is
only around 20% effective at best.
Dr Harry Janssen and colleagues from The
Netherlands assessed whether combination treatment with pegylated
interferon alpha-2b and the antiviral agent lamivudine was
more efficacious in treating chronic hepatitis B infection
than pegylated interferon alpha-2b therapy alone.
"Rates of sustained viral
clearance and reduction of viral load are as high as or higher
than that reported for any other therapy"—The Lancet
Around 300 patients from 42 centers in
15 countries who had chronic hepatitis B were assigned combination
therapy or monotherapy for one year.
36% of patients assigned monotherapy and
35% assigned combination therapy had a sustained viral response
(clearance of the hepatitis B e Ag) indicating disease remission
at the end of the half year follow-up period.
The study also highlights the importance
of hepatitis B virus genotype as a predictor of response to
pegylated interferon aloha-2b treatment.
Dr Janssen comments: “Just like
in chronic hepatitis C, the genotype of the hepatitis B virus
will tell us what the likelihood of response is.”
“It will become our best tool
towards individualized treatment for patients with chronic
hepatitis B”.
Dr Janssen concludes: “Pegylated
interferon alpha-2b is effective and well tolerated for chronic
hepatitis B.”
"Rates of sustained viral clearance
and reduction of viral load are as high as or higher than
those that have previously been reported for any other therapy.”
The Lancet; 2005: 365 online
Back to top
January 11th, 2005
Interferon
Slows Hep C Progression: Research Confirms Low-Dose Therapy
Works for Long-Term Maintenance
SourceURL:http://www.medicalpost.com
By Nancy Deutsch
BOSTON--For the first time, a study confirms
what many doctors thought was true: The progression of hepatitis
C can be prevented or delayed by using pegylated interferon
alfa-2b (PEG-Intron) as long-term maintenance therapy in patients
who have not responded to full-dose interferon therapy.
The study, led by Dr. Nezam Afdhal of
the Beth Israel Deaconess Medical Centre here, is not yet
complete, but the results are promising.
The study includes 550 chronic hepatitis
C patients with advanced fibrosis who have failed interferon
therapy to eradicate the virus. The patients, enrolled in
the COPILOT (Colchicine versus PEG-INTRON long-term) study,
have completed two years of the four-year study. The study
is testing low-dose PEG-interferon alpha-2b against colchicine,
an anti-inflammatory and antifibrotic medication.
Those patients receiving PEG-interferon
alfa-2b have experienced a 50% reduced chance of reaching
a clinical endpoint, such as liver failure or liver transplantation,
compared with patients in the colchicine group.
"It's a totally different approach"
from trying to eradicate the virus with full-dose interferon,
Dr. Afdhal said in an interview. In patients for whom interferon
does not eradicate the virus, many die of complications from
the disease, he said.
"Why not try to lower the dose
(to 0.5 mcg/kg/week) to prevent complications" and see
what would happen, he said he thought before beginning the
study.
The drug does not appear to become less
effective with time, and patients experience much fewer complications
on 0.5 mcg/kg/week, about one-third the regular dose, he said.
Since many patients on interferon fail to complete therapy
due to side-effects, this is an important outcome.
The mid-study results, which Dr. Afdhal
presented at the annual meeting of the American Association
for the Study of Liver Diseases here, showed that of the 550
patients enrolled, 59 had reached a clinical verified endpoint
so far: 39 in the colchicine group (taking 0.6 mg orally twice
a day), but only 20 in the PEG-interferon alfa-2b group.
"This study shows an option
for high-risk patients with advanced liver disease,"
Dr. Afdhal said.
"I think it's important information,"
said Dr. Kelly Kaita, director of the viral hepatitis unit
at the University of Manitoba in Winnipeg. "A lot of
us assumed it would be true, but this proves it to be true."
Dr. Kaita has given patients who did not
have the virus eradicated with full-dose interferon this alternate
regimen of PEG-interferon for about four years now, he said.
"This validates my rationale for using this," he
said. "This is the first large study that gives us a
glimpse into how effective it is."
Back to top
10%
of Babies Infected with HCV Via Moms
SourceURL:http://www.yomiuri.co.jp
/newse/20050111wo71.htm
Yomiuri Shimbun
About 10 percent of babies in the nation
born to mothers who are suffering from hepatitis C are infected
with the hepatitis C virus, according to the findings of a
study by a health ministry team.
For some time now, it has been known that
HCV is transmitted from mothers to children, but this is the
first time that the number of those infected has been established.
The Health, Labor and Welfare Ministry
research team, led by Kazuo Shiraki, professor emeritus of
Tottori University, surveyed a total of 421 pregnant women
suffering from hepatitis C at five medical institutions until
fiscal 2003.
Forty-one of their babies were found to
have been infected with HCV. The infection rate ranged from
7.5 percent to 11.9 percent depending on the type of hospital,
which included university hospitals. The average rate stood
at 9.7 percent, researchers said.
Later this month, Shiraki's team will
issue to hospital doctors a guideline for conducting an HCV
test on pregnant women with due consideration to adverse psychological
effects it may have on them in the event it is confirmed that
they are infected.
While mother-to-child transmission of
hepatitis B is very rare if children are vaccinated against
the disease soon after birth, no vaccine has yet been developed
against HCV, and no methods yet exist to prevent transmission
of the virus from mother to child.
Furthermore, unlike HBV, an HCV test on
pregnant women is not mandatory. As a result, no numerical
data have been available to date on the exact percentage of
HCV transmission from mothers to children, and little is known
about how HCV infection affects children's health.
The research team said it found that mother-to-child
transmission occurred in the case of mothers infected with
large quantities of the virus. There were no cases of infection
when mothers delivered babies by cesarean section, and the
team did not encounter any case of HCV transmission through
breast feeding.
The researchers also found that HCV in
the bloodstreams of about 30 percent of the infected infants
vanished naturally by the age of 3.
While HCV often causes adults to develop
cirrhosis and liver cancer, the HCV-infected children surveyed
by the research team had not suffered liver problems such
as cirrhosis during childhood.
Another health ministry research team
reported that about 40 percent of children who remained HCV-infected
at the age of 4 or later were cured when they were given doses
of interferon.
Shiraki's team shortly will compile a
guideline to instruct doctors to sufficiently brief pregnant
women on HCV issues; carry out an HCV test on pregnant women,
with their consent, if they have received a blood transfusion
or undergone surgery; and check quantities of the virus in
the bloodstreams of both mothers and babies on a regular basis.
The health ministry plans to send the
team's guideline to all relevant hospitals and clinics.
Shiraki told The Yomiuri Shimbun: "Early
discovery of HCV infection can lead to effective treatments
for both mothers and infants. What each doctor has to do is
allay the patient's fears first and keep a close eye on her
condition."
The health ministry is expected to launch
a full-fledged study on countermeasures for hepatitis C by
inviting specialists to form an ad hoc council that will utilize
the findings of the Shiraki team's research.
HCV is transmitted through blood-to-blood
contact. The rate of infection among pregnant women is estimated
at 0.4 to 0.7 percent, or four to seven in every 1,000 pregnant
women.
HCV is a disease that can eventually cause
cirrhosis or liver cancer even though a patient may display
few or no symptoms in the early stages of the disease. Across
the country, more than 1.5 million people are infected with
HCV due to transfusions of tainted blood 10 years ago or more,
repeated use of contaminated needles by drug users, or mother-to-child
transmission.
In December, the health ministry disclosed
a list of medical facilities believed to have received the
HCV-tainted blood product fibrinogen from the defunct Green
Cross Corp. in the 20 years to 2001.
Back to top
Drug
Firms Offer Saving Card for U.S. Uninsured
SourceURL:http://www.reutershealth.com
WASHINGTON (Reuters) - Top pharmaceutical companies launched
a new prescription drug savings card on Tuesday in an attempt
to help reduce costs for the roughly 45 million Americans
without health insurance.
The free card, called Together RX Access,
gives patients access to discounts at pharmacies on brand-name
and generic medicines starting next month for poorer patients
who are too young for Medicare coverage.
To qualify, individual patients without
health insurance must earn no more than $30,000 and be younger
than 65 and a legal U.S. resident. Income requirements are
adjusted based on family size; for example, a family of four
must earn no more than $60,000.
While some health-care groups praised
the new card, others said it highlighted the growing problem
of uninsured Americans, who make up about 15.6 percent of
the population according to the U.S. Census Bureau.
Ron Pollack, head of the liberal-leaning
health care policy group Families USA, said the Together RX
Access card "would offer some important help" but
that U.S. President George W. Bush and Congress needed to
make expanded health care coverage a priority.
Without insurance, patients may be able
to save on prescriptions with special cards but "they
won't even see a doctor to prescribe the medicines they need,"
Pollack said.
The card is similar to another called
Together RX that is offered to Medicare beneficiaries as part
of new prescription drug benefits but includes more participating
firms.
The new card offers uninsured patients
discounts on more than 275 brand-name drugs, compared to 155
drugs for the card for the elderly. Both cards tout savings
of between 20 and 40 percent on brand-name drugs.
Participating companies for the new card
include Abbott Laboratories Inc., AstraZeneca, Bristol-Myers
Squibb, GlaxoSmithKline, Johnson & Johnson, Novartis AG,
Pfizer Inc. Inc., Sanofi-Aventis, and Takeda Pharmaceuticals
North America, Inc..
Drug makers also offer free or discounted
drugs to certain poorer patients through their patient assistance
programs, though such offers vary between companies. Critics
say the programs can be too difficult to enroll in and do
not serve enough needy patients.
Patients can enroll in the new card or
find more information on the Web site www.TogetherRxAccess.com
or by calling 1-800-444-4106.
Back to top
January 12th, 2005
Health
Dept Requests BTSB Report
SourceURL:http://www.rte.ie
The Department of Health and Children has said that it would
like to see the publication of a report by the Blood Transfusion
Service into why 34 donors were not informed they were infected
with the Hepatitis C virus.
The board of the Irish Blood Transfusion
Service is meeting to discuss the report.
RTE News has learned that the 50-page
report by independent German specialist, Dr Bernard Kubanek,
says that close to 100 people initially tested positive for
the virus in the early 1990s, but were not informed at the
time.
Confirmatory testing later reduced the
number infected to 34 people.
The donors were not told for several years
they had the virus and were only informed in 2002 that the
Blood Bank had known about their diagnosis much earlier.
Service faces legal action
The service is facing a series of actions from those
affected who claim they could have been treated earlier had
they known about their infection at the time, and could have
ensured family members were not exposed to the risk of infection.
A spokesperson for the service confirmed
it had received the report, but added that no decision had
been taken on whether it would be published.
The controversy involves the Munster Blood
Centre and its Regional Director, Dr Joan Power. Dr Power
told RTE News she had not seen the report.
She said she had repeatedly called for
a full public inquiry into all matters surrounding her finding
of the Hepatitis C contamination of Anti-D product.
Dr Power said she had submitted a report
to the Taoiseach Bertie Ahern last year and awaited his response.
At the 1997 Finlay Blood Tribunal, Dr
Power admitted an error in not immediately informing a donor
of the test results and was criticised in the report for this.
Back to top
Hersh
& Hersh Files Lawsuit Against Drug Maker Valeant for Brain
Injury Sustained by Plaintiff During Hepatitis C Clinical
Drug Trial
SourceURL:http://biz.yahoo.com
Neither Valeant nor California Pacific Medical Center
Staff Disclosed Harmful Side Effects of Viramidine & Pegasys
Interferon Drug Combination to Patient
SAN FRANCISCO, CA--(MARKET WIRE)--Jan
12, 2005 -- Product liability law firm Hersh & Hersh (www.hershlaw.com)
today announced that it has filed a lawsuit in San Francisco
Superior Court on behalf of plaintiff Linda Iacovetta against
Valeant (NYSE:VRX - News), a Southern California drug company,
and California Pacific Medical Center (CPMC) in San Francisco.
Hersh & Hersh attorneys claim that as a result of participating
in Valeant's clinical trial to test the effects of the combination
of viramidine and pegylated interferon for treating hepatitis
C, Iacovetta developed brain damage and has become permanently
disabled.
CPMC physicians who conducted the clinical
trials are denying they were agents of Valeant and are not
culpable under product liability law. They have requested
a hearing which will take place on Friday, January 14 in San
Francisco Superior Court.
The San Francisco medical lawsuit ties
into the recent barrage of high-profile drug controversies
ignited by the stunning discovery that Vioxx , Celebrex and
even Aleve are now known to cause heart attacks and strokes.
Drug companies have come under fire for over-marketing their
products to doctors while withholding negative findings of
their for-profit clinical trials to the U.S. Food & Drug
Administration, and for paying doctors large sums of money
to enlist their patients in these studies.
According to Nancy Hersh of Hersh &
Hersh, "It is widely known that drug companies turn to
physicians for access to patient volunteers to participate
in studies and that they in turn receive fees for each patient
enrolled. We can show that the CPMC physicians involved in
the hepatitis C drug treatment study did accept payment for
providing patients while knowing their patients would be at
risk of the drug combination's side effects.
"Ms. Iacovetta has been rendered
mentally incapacitated by the fraudulent actions of Valeant
and the CPMC physicians. They are part of the latest scourge
against the drug industry and medical community."
Hepatitis C is the most common blood-borne
viral infection in the U.S., which can inflame and cause irreversible
damage to the liver. It is typically treated with interferon,
often used in combination with anti-viral drug ribavirin,
also manufactured by Valeant. However one of the major side
effects of ribavirin is anemia, a deficiency of the red blood
cells. If anemia is severe patients are forced to take a lesser
dose and ribavirin's effectiveness is sharply diminished.
Valeant began clinical trials of viramidine
in 2003 in combination with pegylated interferon with the
goal of decreasing the occurrence of anemia. But, according
to Hersh & Hersh attorneys, the drug maker and CPMC physicians
failed to appropriately warn users of the dangerous risks
of taking these two drugs together and Iacovetta suffered
the consequences.
Iacovetta originally sought treatment
for hepatitis C at CPMC and was encouraged to participate
in the clinical trial study to test the use of viramidine
and pegylated interferon taken together. She was put on a
regimen of 800 miligrams of viramidine twice daily and 180
micrograms of pegylated interferon once a week, from March
2003 through August 2003.
As a result of the six-month course of
drug therapy, Iacovetta now suffers from brain damage and
cognitive deficits, including memory loss, inability to concentrate,
depression and migraine headaches. Hersh & Hersh attorneys
claim that Valeant and the medical staff of CPMC knew the
threat of neurological damage that this drug combination posed
and concealed it from Iacovetta.
About Hersh & Hersh
Hersh & Hersh is a San Francisco-based law firm dedicated
to protecting the safety and rights of consumers. The law
firm represents clients both on an individual level and in
class and multi-district litigation, and has pursued and won
a wide range of civil suits, from product liability, medical
malpractice and insurance bad faith to sexual harassment and
employee discrimination.
For the past 32 years, Hersh & Hersh
has been committed to using the law to protect individuals
by making sure companies exercise due diligence in manufacturing
their products and operate in good faith in delivering their
services.
Contact:
Hersh & Hersh Press Contact:
Shelly Gordon
650/856-1607
sgordon@g2comm.com
Source: Hersh & Hersh
Back to top
Chronic
Hepatitis B and C: Chronic Lack of Effective Treatment
SourceURL:http://www.medadnews.com
LONDON, Jan. 12, 2005--The World Health
Organization (WHO) estimates that one-third of the entire
world’s population has been exposed to hepatitis B (HBV)
resulting in an estimated 350-400million chronically infected
patients globally. Most of these patients reside in Southeast
Asia and Sub-Saharan Africa and in most cases are infected
at birth. However the seven major pharmaceutical markets*
(including the USA) are estimated to harbour up to seven million
chronic carriers, with transmission occurring primarily through
sexual contact during adulthood. Additionally, while Hepatitis
C (HCV) infection is less common, the WHO estimates the numbers
of chronically infected individuals at a further 200m. Perhaps
most frightening of all however, is that less than one third
of patients with either chronic hepatitis B or C (CHB or CHC)
are actually receiving treatment.
Viral hepatitis --“ a significant
public health problem”
Globally, HCV infection is less common than HBV infection.
However in the west, HCV (7.5m chronic carriers in the seven
major markets) is more common than HBV. Historically this
has been due to transmission through contaminated blood or
blood products and is currently a result of shared utensils
used for intravenous drug use.
Recently completed research by independent
market analyst Datamonitor** has revealed that despite increasing
HBV and HCV disease awareness and diagnosis, treatment rates
of patients with chronic viral hepatitis remain low, and despite
the large pool of CHB and CHC patients, less than one-third
of these are currently receiving medical treatment. One underlying
reason is the low rate of disease diagnosis, on average 54%
for HBV and 40% for HCV, says Datamonitor infectious diseases
analyst Brigitte de Lima. “Chronic liver disease (CLD)
is a long-term consequence of HBV and HCV and commonly leads
to liver cirrhosis or hepatic decompensation within 10-40
years following primary infection.”
“Furthermore, long-term CHB
and CHC cause a type of liver cancer known as hepatocellular
carcinoma (HCC). Both diseases combined account for over 80%
of HCC cases and almost half a million lives annually. Once
diagnosed, prognosis for HCC can be as low as six to eight
months.”
Diagnosis and treatment -- still
sub-optimal in the seven major markets
Although HCV diagnosis rates are lower than those for HBV,
they have increased considerably in the past two years, while
those for HBV have remained flat. Key to the enhanced identification
of new patients among both high-risk groups and the general
population has been education and awareness campaigns organized
by both the private and the public sector, de Lima says.
“In addition to the low rates
of diagnosis, inadequate therapies also account for the sub-optimal
treatment levels. Although up to 80% of CHC patients with
the easy-to-treat viral genotypes 2 and 3 can currently be
cured, the larger prevalence of the less responsive genotype
1 translates into only half of the total patient pool achieving
virus eradication.”
“In the case of CHB the scenario
is even worse, with viral eradication occurring in less than
5% of all patients. Current CHB therapy therefore focuses
on long-term suppression of virus replication rather than
virus clearance. Similar to CHC, the proportion of patients
less responsive to treatment, namely those infected with the
HBeAg-negative variant of HBV, is increasing globally.”
Sub-optimal current first-line therapies
for CHB and CHC are unable to benefit the already predominant
and increasing pools of difficult-to-treat patients, leaving
ample scope for opportunistic manufacturers willing to invest
in potent, tolerable drugs in a market largely driven by therapy
cost, de Lima says.
Prescription choice -- largely
driven by cost-considerations
The pharmaceutical HBV market is currently dominated by two
antivirals, GlaxoSmithKline (GSK)’s Zeffix (lamivudine,
LAM) and Gilead’s Hepsera (adefovir dipivoxil, ADV).
Datamonitor’s research reveals that the preference of
the former for first-line therapy is predominantly cost-driven,
as the price of Zeffix is substantially lower than that of
Hepsera, de Lima says. “ADV is commonly reserved for
second-line therapy following the development of resistance
to LAM, which can occur in up to 67% of patients after four
years of therapy. For CHC, the standard of care is now pegylated
interferon (pegIFN) and ribavirin (RBV) combination therapy.”
“Similarly, the HCV market
consists of two major players; Schering-Plough, who markets
PegIntron and Rebetol, and Roche, with its drugs Pegasys and
Copegus. The lack of clinical differentiation between the
two rival pegIFNs and the absence of any alternative anti-HCV
drugs has led to physician prescription choice being driven
almost exclusively by cost and special deals provided by the
manufacturers.”
Current therapies -- compromise
is necessary
Current therapies for either disease are far from being perfect
solutions. None of the HBV drugs cure the disease and long-term
therapy with LAM is associated with development of resistance,
while ADV entails a high financial expenditure. Pegylated
IFN combination therapy might be effective in some forms of
CHC disease, but it is also a therapy dreaded by most patients
due to the injectable mode of delivery and the high incidence
of severe side effects elicited over the entire course of
the treatment, de Lima says.
“Given the clear limitations
of the current HBV and HCV therapies, major players in both
pharmaceutical markets have developed different strategies
aimed at increasing treatment rates. In the case of CHC, these
focus on treating patients with normal alanine aminotransferase
(ALT) levels, prolonging treatment for slow responders and
maintaining non-responders on pegIFN monotherapy. The main
strategy for CHB patients is the extension of therapy, especially
for HBeAg-negative patients, as most patients relapse following
cessation of therapy.”
The current stalemate in the CHB and CHC
treatment markets is only susceptible to being broken with
the launch of new developmental drugs, which will have to
combine high potency and good tolerability at a reasonable
cost. Crucially, new drugs are more likely to gain market
share if, in addition to winning the battles against the more
responsive variants of the diseases, they are also effective
in the difficult-to-treat CHB and CHC patients. Drugs with
high potency in the latter patients are the key to meeting
the growing therapeutic needs and consequently boosting treatment
rates, de Lima says.
“The future viral hepatitis
treatment landscape is predicted to follow the HIV precedent,
in that drug monotherapy is likely to become obsolete and
novel, potent drugs will be administered simultaneously as
part of a combination. Furthermore, the focus needs to shift
from patients with easily treatable variants of the disease
to those that obtain little benefit from current therapies,
as these are steadily accumulating in the total patient pools.
New strategies are awaited to take the lead in this long-standing
battle against the hepatitis viruses.”
Notes for editors
*The seven major pharmaceutical markets
are the USA, the UK, France, Germany, Italy, Spain and Japan
**Stakeholder Insight: Hepatitis B and C
Brigitte de Lima, Datamonitor infectious
disease analyst and report author is available for comment
To arrange an interview or for further
details regarding the report contact Matthew Dick in the Datamonitor
Press Officer on + 44 20 7675 7824, or email mdick@datamonitor.com
For US, please call on +1 212 652 5387
For Asia-Pacific, please call Denis Mason on +61 2 9006 1526.
Datamonitor plc (DTM.L) is a premium business
information company specialising in industry analysis. We
help our clients, 5000 of the world's leading companies, to
address complex strategic issues. Through our proprietary
databases and wealth of expertise, we provide clients with
unbiased expert analysis and in-depth forecasts for six industry
sectors: Automotive, Consumer Markets, Energy, Financial Services,
Healthcare, Technology. Datamonitor maintains its headquarters
in London and has regional offices in New York, San Francisco,
Sydney, Tokyo, Frankfurt, Shanghai and Hong Kong. See www.datamonitor.com
for further details. To unsubscribe, please send an email
to: unsubscribe-27168@emaillabs.com
with the address: editorial@engelpub.com
in the subject line.Datamonitor Charles House, 108-110 Finchley
Road London, NW3 5JJ
Back to top
January 13th, 2005
Obliteration
of Portal-Systemic Shunts Benefits Patients
SourceURL:http://www.gastrohep.com
Obliteration of portal-systemic shunts followed by partial
splenic artery embolization benefit patients with portal-systemic
encephalopathy, reports the most recent issue of The American
Journal of Gastroenterology.
Dr Yoshida and colleagues from Japan undertook
a study in order to evaluate the long-term results of angiographic
partial splenic artery embolization (PSE) as a supplemental
treatment of portal-systemic encephalopathy.
The researchers enrolled a total of 25
patients with portal-systemic encephalopathy and then divided
them into 2 groups.
The first group of 14 patients underwent
transportal obliteration and/or balloon-occluded retrograde
transvenous obliteration (BRTO) of portal-systemic shunts
(PSS), followed by portal-systemic encephalopathy (PSE(+)
group).
The second group of 11 patients underwent
only transportal obliteration and/or balloon-occluded retrograde
transvenous obliteration of portal-systemic shunts (PSE()
group).
Grades of encephalopathy were higher
at pretreatment than at 1 wk posttreatment in both groups—The
American Journal of Gastroenterology
The researchers found that portal venous
pressures pretreatment was similar to posttreatment in the
PSE(+) group, but lower than posttreatment in the PSE() group.
The research team found that serum ammonia
levels were higher at pretreatment than at 1 wk posttreatment
in both groups.
The researchers noted that the levels in
the 2 groups were similar at pretreatment, 1 wk, 3 months,
3 yr, 4 yr, and 5 yr posttreatment.
However, serum ammonia levels were lower
in the PSE(+) group than in the PSE() group 6 months, 9 months,
1 yr, and 2 yr posttreatment.
The researchers found that the grades of
encephalopathy were higher at pretreatment than at 1 wk posttreatment
in both groups, but the levels in the 2 groups were similar
at pretreatment, 1 wk, 2 yr, 3 yr, 4 yr, and 5 yr posttreatment.
However, the research team also noted that
grades of encephalopathy were lower in the PSE(+) group than
in the PSE() group 3 months, 6 months, 9 months, and 1 yr
posttreatment.
Dr Yoshida concluded, "Obliteration
of PSS followed by PSE benefit patients with portal-systemic
encephalopathy."
The American Journal of Gastroenterology;
2005: 100 (1): 43-47
Back to top
Hepatitis C
Caring Ambassadors Program Releases New, 3rd Edition of Hepatitis
C Choices
OREGON CITY, Ore.--(BUSINESS WIRE)--Jan.
13, 2005--The Hepatitis C Caring Ambassadors Program (HCCAP)
proudly announces the Internet release of the newly updated
3rd edition of Hepatitis C Choices: Distinctive Viewpoints
on Choices for Your Hepatitis C Journey. The book is
authored by a team of 20 leading medical experts and patient
advocates. Hepatitis C Choices presents an objective review
of conventional and alternative treatment options for the
more than four million Americans currently infected with the
hepatitis C virus (HCV). It is the only book of its kind currently
available.
Hepatitis C Choices thoroughly
reviews conventional (western) treatment along with naturopathic,
Ayurvedic, homeopathic, and traditional Chinese medicine management
approaches. Other important topics such as disease progression,
nutrition, laboratory testing, and health care consumer information
are also included. In addition to extensive updates, the 3rd
edition of Hepatitis C Choices has two new chapters on integrative
medicine and immunology. According to Dr. Robert Gish, Medical
Director of the Liver Transplant Program at California Pacific
Medical Center in San Francisco, "Hepatitis C Choices
provides not only choices on treatment for hepatitis C, it
delivers a detailed overview of background information for
patients seeking answers to key facts on why their specific
treatment pathway is correct for them."
Hepatitis C is the most common blood-borne,
chronic viral infection in the United States. An estimated
three to five million Americans are currently infected with
HCV, an infection spread by blood-to-blood contact. HCV is
the leading cause of chronic liver disease in the U.S. and
the most common indication for liver transplantation. The
hepatitis C epidemic was the subject of a recent oversight
hearing conducted by the Congressional House Government Reform
Committee.
The Hepatitis C Caring Ambassadors Program
is a national, nonprofit organization dedicated to increasing
awareness about the hepatitis C epidemic and improving the
lives of those afflicted with the disease. HCCAP produced
Hepatitis C Choices as part of its mission to educate
the public and health care community about HCV. HCCAP believes
it is vitally important for people with hepatitis C to equip
themselves with information about the illness and all available
treatment options. Education is essential for making informed
choices and taking charge of one's health.
The 3rd edition of Hepatitis C Choices
is available for free download at the Hepatitis C Caring Ambassadors
Program Internet site at www.hepcchallenge.org.
For additional information about Hepatitis
C Choices or the Hepatitis C Caring Ambassadors Program,
contact Lorren Sandt at 1-877-737-4372.
Back to top
Hepatitis
Victim Wins Cash Ruling
Source: http://www.thestar.com/
TRACEY TYLER
LEGAL AFFAIRS REPORTER
Provincial employee infected at work Due
more than $100,000 for suffering
An appeals tribunal has ordered the Ontario
government to compensate a former counsellor who was infected
with hepatitis C while working at a provincially-run institution
for the disabled.
It's the first time in Ontario an employee's
exposure to hepatitis C - in a case that doesn't involve needles
or blood transfusions - has been found to constitute a workplace
injury, said Michael Pretsell, a lawyer who represented the
man.
Pretsell said his client, who wishes to
remain anonymous, is "extremely happy" but concerned
that several hundred other employees of the former Prince
Edward Heights institution in Picton may have been exposed
to the disease and should be tested.
"He's concerned that other people
may be infected but may be asymptomatic and don't know it,"
he said yesterday, adding the provincial government has so
far refused requests to warn former employees of a possible
risk.
It also spent 10 years denying his client
was infected at work, Pretsell said.
A spokeperson for Community and Social
Services Minister Sandra Pupatello, whose ministry managed
the institution, promised to look into the issue but did not
call back yesterday.
Pretsell's client worked at the institution
from 1980 to 1995, caring for mentally disabled adults, including
attending to their personal hygiene. He didn't know he was
infected until he went to give blood in 1994 and was tested.
A specialist later confirmed the condition.
In March, 1995, after suffering an emotional
breakdown, he applied to the Workplace Safety and Insurance
Board for benefits, but a resolutions officer turned him down.
He appealed the decision to the Workplace Safety and Insurance
Appeals Tribunal and eventually won.
In a decision released late last year,
a three-member panel said while there was no medical or scientific
proof as to how the man was infected, the evidence was sufficient
to support his theory he was exposed to hepatitis C in the
workplace. His condition, in turn, contributed to his later
mental stress, the tribunal said.
It ordered the province to pay him health
care benefits, compensation for five to six years of lost
wages and an award similar to damages for pain and suffering.
It's now up to the board to determine the
exact amount but it will probably be about $110,000 to $120,000,
said Pretsell.
Pretsell said his client's evidence "was
just bulletproof" and accepted by the board verbatim.
"He was the perfect client for this
case. He didn't use intravenous drugs or have extramarital
affairs, so they couldn't argue he got it (hepatitis C) some
other way and was just trying to scoop up some cash by blaming
the employer."
A major source of distress for his client,
who donated blood regularly prior to 1994, is that he may
have been passing along tainted blood up until the time he
was tested, he said.
What makes the case unusual, he added,
is that other instances of workers infected with hepatitis
C have tended to stem from a workplace injury that requires
surgery. In those cases, the disease has usually been passed
on from a blood transfusion related to the operation.
Pretsell's client testified that he had
been scratched many times and bitten on at least one occasion.
His duties regularly involved the "intimate personal
care" of disabled residents and exposure to vomit, feces
and blood, the tribunal said, adding that nine of 16 residents
he cared for had been exposed to hepatitis B.
While they had not been tested for hepatitis
C, there was evidence that their exposure to hepatitis B made
it more likely that they had both diseases, according to medical
evidence given to the tribunal. That increased the risk for
employees at the institution, the tribunal found.
Back to top
January 14th, 2005
Update
from Cardinal Health Regarding Baltimore-Area Hepatitis C
Investigation
PRNewswire
Source: Cardinal Health, Inc.
DUBLIN, Ohio, Jan. 13, 2005 -- Cardinal
Health today provided the following update regarding recent
Hepatitis C infections in the Baltimore area. First and foremost,
we want to reiterate that our thoughts and sympathies continue
to be with the patients and families affected. Our overriding
priority remains protecting the safety and welfare of the
patients who use the products we supply.
As previously reported, Cardinal Health
voluntarily closed its Timonium, Md., pharmacy on Dec. 6,
2004, immediately after learning the facility might be involved
in several reported cases of Hepatitis C in the greater Baltimore
area. Today, the Maryland Board of Pharmacy also formally
suspended operations at the pharmacy. We would like to underscore
that this suspension order does not represent any change in
what Cardinal Health has been doing since first learning of
the reported cases of Hepatitis C and the resulting investigation.
While the cause of the infection is still
unknown, the DHMH is focusing its inquiry on the possible
cross contamination of a single vial of a tracer agent from
a specific blood labeling procedure at the Timonium pharmacy.
The department has stated that the investigation points to
a unique event and not an ongoing public health risk. We will
continue to work with the DHMH on this investigation and with
the Maryland Board of Pharmacy on its interim observations
in the suspension order.
During the past 20 years, Cardinal Health’s
radiopharmacies have prepared more than 100 million doses
of radiopharmaceuticals without similar incident. The company
has long-standing policies to protect patient safety that
have set the highest standards for quality in our industry,
meeting and often exceeding federal, state and local procedural
requirements. Throughout the course of this investigation
and upon its conclusion, we will continue to ensure that the
training, safeguards and procedures in place at each of our
radiopharmacies uphold these standards.
We are deeply concerned for the patients affected in this
matter. Cardinal Health remains committed to doing whatever
is necessary to protect patient safety, maintain the trust
of our customers and support the patients they serve.
As we assist state authorities in the timely
resolution of this matter, we will continue to update customers
and patients of ongoing developments via http://www.cardinalhealth.com/
.
Media:
Angela Gardner Jim Mazzola
(614) 757-6250 (614) 757-3690
angela.gardner@cardinal.com
jim.mazzola@cardinal.com
Back to top
January 15th, 2005
Experts
Warn against Growth Of Hepatitis C on LI
Newsday
BY DELTHIA RICKS
STAFF WRITER
The growing prevalence of hepatitis C on
Long Island could pose a greater threat than the emergence
of HIV two decades ago, a health expert said Friday.
Doctors, researchers, community activists
and people with the blood-borne infection testified in Manhattan
before members of two state Assembly committees asking legislators
to take action. The disease can cause irrevocable liver damage.
Experts predict an epidemic could overwhelm health systems
and overload waiting lists for transplantable livers.
"This is just the start of a tidal
wave that is going to hit in 2015 to 2020," said Dr.
Alain Litwin, an infectious disease expert from Albert Einstein
School of Medicine in the Bronx.
Many hepatitis C infections resulted from
transfusions in the 1970s, before the virus was screened in
the blood supply.
But health experts Friday spoke of a more
recent wave of infections driven by a craze over the street
drug crystal methamphetamine. Shared needles and other drug
paraphernalia has touched off a spate of new infections in
the state.
Jayne Green of the Nassau County Department
of Drug and Alcohol Addiction, said while hepatitis C infections
on Long Island come nowhere near the proportion in the city,
the virus is becoming increasingly problematic here.
"Hepatitis C has a potential to be
a greater threat than HIV in the 1980s and 1990s," on
Long Island, she told legislators. Unlike other forms, hepatitis
C takes up to 20 years to manifest. When detected early, it
can be effectively controlled.
"There has been a problem with non-compliance,"
Green said. "All clients testing positive are referred
to Nassau University Medical Center. But many don't go because
they are unable to pay," she said.
While there are no firm hepatitis C prevalence
figures on Long Island, Green said her agency is seeing more
cases and of the 326 people counseled recently about the virus
at her agency, 56 percent tested positive. An additional trend,
she said, is the growing percentage co-infected with HIV.
Crystal methamphetamine has attracted a
growing number of users in urban and suburban areas. Its link
to hepatitis C is undeniable, experts say.
The Centers for Disease Control and Prevention
estimates that within a decade there will be a 279 percent
increase in the incidence of liver damage nationwide due to
hepatitis C, a 528 percent increase in the need for transplants
and a 223 percent increase in the liver-related death rate.
Hepatitis C is one in a family of infectious
viruses that attack the liver. Hepatitis A and B, whose prevalence
also is rising in New York, are preventable through vaccines.
All three viruses can be transmitted through
the blood -- by sharing needles for example. Hepatitis C and
B also can be transmitted sexually. Hepatitis A is noteworthy
as a contaminant of food and water.
Back to top
Depression
Caused by Common Treatment for Hepatitis C May Affect Outcome
Emory University Health Sciences Center
An article appearing in the January 2005
issue of Brain, Behavior and Immunity suggests that
developing depression while on interferon-alpha plus ribavirin
may impact how well the medications work.
In a study conducted in the Department
of Psychiatry and Behavioral Sciences at Emory University
School of Medicine, Charles L. Raison, MD, Andrew Miller,
MD, and colleagues, observed that patients who develop depressive
symptoms during interferon-alpha plus ribavirin therapy were
significantly less likely to have cleared the hepatitis C
virus from their blood following six months of treatment.
"Hepatitis C infection affects three
to five million Americans, and is the leading cause of liver
transplantation," said Dr. Raison. "With advances
in treatment, 40-50 percent of patients can be cleared of
the virus. Unfortunately, however, the current treatment for
hepatitis C - interferon-alpha plus ribavirin - produces a
high rate of psychiatric side effects that have long been
recognized as impediments to successful antiviral therapy.
In the past we primarily worried that depression interfered
with quality of life, or would cause patients to stop taking
the medicine. These new data suggest that even if patients
stay on treatment, they are less likely to have a good outcome
if they develop depression."
The study examined 103 participants who
received pegylated interferon-alpha-2b plus ribavirin (PEG
IFN/ribavirin). All participants were psychiatrically evaluated
prior to initiation of the medication and at 4, 8, 12 and
24 weeks of PEG IFN/ribavirin treatment.
Only 34% of the patients who had a significant
increase in depression cleared the hepatitis C virus from
their blood at 24 weeks, as compared to 59%-69% of patients
with milder increases in depression. The effect of depression
on viral clearance persisted even after adjusting for factors
known to affect treatment outcome, such as viral genotype,
or whether medications had to be reduced.
"The findings of this study provide
preliminary evidence that baseline mood state should be assessed
in patients prior to commencing treatment," said Dr.
Raison. "Significant deviations from this state may increase
the likelihood of treatment failure. Moreover, these findings
provide further support that the development of depression
can have a negative impact on health outcomes in medically
ill subjects."
Researchers from the Rollins School of
Public Health, Emory University and the Department of Medicine,
Gasteroenterology and Hepatology, Weill Medical College of
Cornell University were also involved in the study. The study
was supported by grants from the National Institute of Mental
Health, Schering-Plough, and the Centers for Disease Control
and Prevention.
Kathi Baker
kobaker@emory.edu
404-727-9371
Emory University Health Sciences Center
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