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Alan Franciscus
Editor-in-Chief
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In This Issue:
• Schering-Plough
Admits to Paying Kickback
• 2,000th
Liver Transplant Marks a Milestone
• Hepatitis
C Drug for Extra 3000
• Liver
Transplant Recipient Posts "Thank You" Billboards
• Nucleic
Acid-Amplification Testing Further Safeguards Nation's Blood
Supply, NHLBI Study Shows
• Probability
of Viremia among Tissue Donors in the United States
August 14th, 2004
Schering-Plough
Admits to Paying Kickback
David Schwab
Source: Star-Ledger
Marking an end to a highly publicized case,
drug maker Schering- Plough formally pleaded guilty yesterday
to a charge of paying an illegal kickback to an HMO to help
bolster sales of its blockbuster allergy medicine, Claritin.
Brent Saunders, the company's senior vice
president for global business compliance and business practices,
entered the guilty plea on behalf of the company during a
hearing in Philadelphia before U.S. District Court Judge Petrese
Tucker.
Petrese said one reason she accepted the
plea Schering-Plough negotiated with federal prosecutors was
that the company had a new management team, including Saunders.
"It appears this is a totally different company,"
she said.
Most of the company's senior executives
have been replaced since Fred Hassan, the former chief executive
officer at Pharmacia, was hired to run Schering-Plough last
year.
Last month, the U.S. Attorney's Office in Philadelphia announced
Schering-Plough had agreed to plead guilty to one criminal
charge and to pay $345 million in criminal penalties and civil
fines to the government.
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August 17th, 2004
2,000th
Liver Transplant Marks a Milestone
Source: PRNewswire
OMAHA, Neb.,17 -- The Nebraska Medical
Center and its partner, the University of Nebraska Medical
Center (UNMC), have reached a milestone shared by only five
other transplant centers in the country by performing more
than 2,000 liver transplants. "It's an extraordinary
milestone," said Alan Langnas, D.O., chief of transplantation
at The Nebraska Medical Center and UNMC professor of surgery.
"It means so much to all of the people
who began the program and those who have worked tirelessly,
investing so much time and energy into making this program
possible."
"I think the same spirit of enthusiasm for getting the
thing started has helped sustain it," said Byers Shaw,
Jr. chief of surgery at The Nebraska Medical Center and professor
and chairman of the UNMC department of surgery.
Dr. Shaw was instrumental in bringing the
program to Omaha nearly 20 years ago. "I remember sitting
on the plane after a visit thinking, 'this would be a place
where you couldn't go wrong in terms of starting something
new like this, when so many people are really enthusiastic
and are invested in making this work,'" he said.
"It's an incredible thing to think
all of the wonderful and heroic patients over the years who
have inspired us to keep doing what we're doing and, of course,
try to do it better all of the time," Dr. Langnas added.
Patients like 2-year-old Cameron Brecka
of Staplehurst, Neb. The once healthy toddler was diagnosed
with hepatoblastoma, a rare type of liver cancer, one day
before his second birthday.
"All I could say was 'Oh my!'"
said Casey Brecka, Cameron's mother. "We realized that
we were dealing with something pretty awful."
Cameron started on chemotherapy, which didn't prove effective
against the tumor; and it couldn't be removed surgically because
the tumor had grown into the blood vessels of the liver. That
left Cameron and the Brecka family in the hands of the liver
transplant team.
"It's hard to watch a stranger take
your child down a long hallway to the operating room for a
liver transplant," Casey said. "But it was easier
knowing that a hand-picked, well-trained and experienced transplant
surgeon was waiting for him."
That surgeon, Debra Sudan, M.D., knew when
she went in to the O.R. that the 2,000th liver transplant
would be performed that night. She didn't know which of the
three patients it would be.
"It turned out to be Cameron and I
was happy for him. He is a very nice little boy and his family
is wonderfully supportive and just a pleasure to care for,"
said Dr. Sudan. "To be No. 2,000 is nice for the family.
For our program, I think it shows that we have a lot of experience
and when it comes to transplantation you can't have too much
experience," Dr. Sudan added.
That experience can be traced back nearly 20 years to the
program's first liver transplant, patient Frank Wood. His
wife, Hazel, remembers the medical team fondly.
"I am extremely grateful to those
who took care of Frank. They allowed us many more happy years
together," Hazel said. Frank Wood, transplanted in 1985,
passed away from Alzheimer's disease in October 2002 at the
age of 71.
"I know Frank would have been very pleased to hear about
the 2,000th transplant. He'd be pleased to know how far they've
come," said Hazel.
Only five other transplant centers have reached 2,000 liver
transplants. They are: UCLA, Pittsburgh, Jackson Memorial
Hospital in Miami, Baylor, and Mt. Sinai in New York.
Laurie Williams, R.N., helped care for Frank after he was
transplanted.
She continues her work with the transplant team and says even
after 2,000 patients nothing is routine.
"We may have been a bit more 'nervous' for the first
transplant and how everything would fit together and we might
now be a bit more adept at anticipating problems and finding
solutions, but every patient and family situation is unique
and challenging," Williams said. "It's having the
ability, knowledge and skill to help preserve life and the
caring and thoughtfulness to form unforgettable relationships
that keeps us all coming back day after day."
The impact of the transplant team's emotional
investment is immeasurable.
The economic impact, however, tops a half
billion dollars. Since the program first began in July 1985,
liver transplantation has brought approximately
$578.6 million into the state of Nebraska,
including the Omaha metropolitan area.
"Most importantly, having done 2,000 transplants is a
tribute to the many donor families that have given the gift
of life in their time of tragedy," said Dr. Sudan. "The
recipients have no way to repay this gift, but are very grateful
that there are so many generous people here in our country."
"I am forever indebted to these people,"
said Casey Brecka. "I don't even have the words to express
how grateful I am. They saved my son's life."
"We are lucky to have brilliant surgeons,
extraordinary caseworkers, nurses, psychologists and child
specialists who grab on to the challenge of transplant,"
said Dr. Langnas. "When you really get down to it, it's
because we're in Nebraska. Special people live here. I think
that it's the Nebraskans and the Nebraskan approach to the
world that has allowed us to become what we are -- a world-class
transplant center committed to serious medicine and extraordinary
care."
With a history dating back to 1869, The
Nebraska Medical Center, known for excellence, innovation
and quality patient care is listed as one of America's Top
Hospitals by US NEWS & WORLD REPORT. As the teaching hospital
for the University of Nebraska Medical Center, this 735 licensed
bed facility has an international reputation for providing
solid organ and bone marrow transplantation services and is
well known nationally and regionally for its oncology, neurology
and cardiology programs. The Nebraska Medical Center can be
found online at http://www.nebraskamed.com
UNMC is the only public health science
center in the state. Its educational programs are responsible
for training more health professionals practicing in Nebraska
than any other institution. Through its commitment to education,
research, patient care and outreach, UNMC has established
itself as one of the country's leading centers in cancer,
transplantation biology, bioterrorism preparedness, neurodegenerative
diseases, cardiovascular diseases, genetics, biomedical technology,
opthalmology and arthritis.
UNMC's research funding from external sources is now more
than $68 million annually.
SOURCE Nebraska Medical Center
Web Site: http://www.nebraskamed.com
Photo Notes: NewsCom:
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August 19th, 2004
Hepatitis
C Drug for Extra 3000
Source: New Zealand News
Pharmac, the Government's pharmaceutical management agency,
has decided to extend the funding of a drug that can cure
hepatitis C.
From next month, the funding of Pegasys
(peginterferon alfa-2a) will be extended to patients with
chronic genotype 2 or 3 hepatitis C who also have bridging
fibrosis or liver cirrhosis.
Hepatitis C is a serious virus carried
in the blood that can damage the liver, leading to cirrhosis
(scarring), liver failure and liver cancer.
About 30,000 New Zealanders have hepatitis
C, about half of them genotype 2 or 3, and about 20 per cent
of those will have cirrhosis.
Patients with cirrhosis due to hepatitis
C have a high chance of dying from progressive liver disease.
Pegasys has been funded for chronic genotype 1 hepatitis C
since March.
Manufacturer Roche says Pegasys is a new
therapy for hepatitis C that is normally used with another
antiviral agent, ribavirin.
It offered patients with hepatitis C and
cirrhosis the best chance of a cure when compared with standard
interferon therapy, the company said.
Pegasys cured 43 per cent of patients across
all genotypes with cirrhosis, compared with 33 per cent for
standard interferon.
Another study showed 75 per cent of genotype 2 and 3 patients
with advanced liver disease or fibrosis were cured by Pegasys
treatment in combination with ribavirin, the company said.
"Extended funding of Pegasys ensures
more New Zealanders living with chronic hepatitis C have a
greater chance of being cured of the disease," said Roche
Products (NZ) managing director Rob Mitchell.
Common side-effects from Pegasys can include
flu-like symptoms, nausea, difficulty sleeping, poor concentration,
temporary hair loss, loss of appetite, diarrhoea, itchiness,
irritability, dizziness, depression or anxiety, and reaction
at the injection site.
Rare and more serious side-effects can
include severe chest pain, suicidal thoughts, persistent cough,
trouble breathing, irregular heart beat, vision problems,
severe stomach pain, confusion, unusual bleeding or bruising,
fever or chills, tingling fingers and toes.
- NZPA
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Liver
Transplant Recipient Posts "Thank You" Billboards
Source: Associated Press
HOUSTON Todd Krampitz got his new liver
through a billboard-and-Internet appeal.
Now, the 32-year-old Houston man's family
has posted a new billboard to send out a big "thank you"
for the liver donation that saved his life.
An out-of-state donor family specified
that the liver go to Krampitz, who was diagnosed with liver
cancer in May.
Krampitz was discharged Monday from The
Methodist Hospital on Monday after getting the transplant
late last week.
The Houston Chronicle reports the billboard
went up yesterday on the Southwest Freeway near Bellfort.
It bears Krampitz's picture and says -- quote -- "Thank
you! Give the gift of life. Become an organ donor."
On the Web:
Krampitz site: http://www.DonateLife.net
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Nucleic
Acid-Amplification Testing Further Safeguards Nation's Blood
Supply, NHLBI Study Shows
State-of-the-art testing systems to screen donated blood have
improved the safety of the nation’s blood supply by
preventing the transmission of potentially deadly viruses,
according to a new study funded by the National Heart, Lung,
and Blood Institute (NHLBI), a component of the National Institutes
of Health. Nucleic acid-amplification testing (NAT) has helped
prevent the transmission of approximately five HIV-1 infections
and 56 hepatitis C virus (HCV) infections each year since
it began being used in the United States as an investigational
screening test in mid-1999. The study is published in the
August 19 issue of the New England Journal of Medicine.
“Risks to blood recipients from transfusion-transmitted
viruses such as HIV and hepatitis are already extremely low,
in part because of increased surveillance and improved testing,”
said Barbara Alving, M.D., NHLBI acting director. “NAT
enhances the safety of the nation’s blood supply by
further reducing these risks.”
The study is the first and only one of
its scope to show the effectiveness of the NAT assay system
nationally. All major blood donation laboratories in the United
States participated, accounting for more than 98 percent of
tested blood donations. Many organizations collaborated on
the research, including the American Red Cross, Blood Systems
Research Institute, America’s Blood Centers, the Food
and Drug Administration (FDA) and the Centers for Disease
Control and Prevention.
The study investigators analyzed all donations
that detected ribonucleic acid (RNA) from HIV-1 and HCV by
NAT between 1999 and 2002. The researchers then looked to
see which of these infected donations had been missed by tests
to detect viral antibodies or antigens (proteins from the
virus), the types of screening previously used. They concluded
that NAT reduced the risk of HIV-1 and HCV infections associated
with blood transfusion to approximately 1 in 2 million blood
units. In comparison, other blood screening tests are associated
with rates of 1 in 1.5 million for HIV-1 and 1 in 276,000
for HCV.
Blood donors have been tested for evidence
of HIV infection since 1985 and for evidence of HCV infection
since 1990. Although increasingly sensitive tests to detect
HIV and HCV antibodies and HIV antigen were implemented during
the past decade, in rare instances infections in donors have
been missed. This is due to the “window period”
during which a donor can be infected but still test negative
on screening tests.
The NAT system, which was approved for
use in 2002 by the FDA, can detect HIV and HCV infections
in blood donors earlier than other screening tests because
it detects viral genes rather than antibodies or antigens.
The appearance of antibodies requires time for the donor to
develop an immune response, and detection of antigens requires
time for a higher level of virus to appear in the bloodstream.
With the use of NAT for HCV, the window
period is reduced by approximately 57 days (from an average
of 82 days to 25 days). For HIV-1, the average window period
with antibody is approximately 22 days. This is reduced to
approximately 11 days with the NAT tests used in this study.
The use of NAT has allowed blood banks to discontinue two
less effective screening tests — HIV-1 antigen testing
and a test for a nonspecific marker for HCV. Blood donations
continue to be screened with antibody tests for HIV, HCV,
and other viruses, which helps ensure the safety of the blood
supply.
“NAT not only improves the safety
of our already safe blood supply, but the technology can be
quickly adapted to screen for emerging viruses,” said
George Nemo, Ph.D., project officer of the study and group
leader of the Transfusion Medicine and Cell Therapies Scientific
Research Group at NHLBI.
For example, last year, screening for West
Nile virus was implemented in less than nine months with the
collaboration of the CDC and FDA and the rapid development
of NAT by manufacturers. Nearly 1,000 blood donors with West
Nile virus infection were identified by NAT and their donations
discarded.
“These findings also reflect an unprecedented, national
cooperative effort by blood collection centers, industry,
and federal agencies, which greatly enhances the ability of
blood donation centers to rapidly incorporate new tests as
needed,” added Nemo. “This collaboration also
facilitates our ability to conduct ongoing and timely surveillance
of the nation’s blood supply.”
NAT also makes it possible to identify
persons in the very early stages of HIV-1 and HCV infection.
This information may help the medical community better understand
risk factors associated with viral infection and the natural
history, disease progression, and treatment for these infections.
One of the NAT systems used in the study
was first developed in the mid-1990s by Gen-Probe Incorporated,
in collaboration with Chiron Corporation, with support for
research and development provided by NHLBI. Results of screening
by the NAT system manufactured by Roche Molecular Systems
were also included in the study.
NHLBI is part of the National Institutes
of Health (NIH), the Federal Government's primary agency for
biomedical and behavioral research. NIH is a component of
the U.S. Department of Health and Human Services. NHLBI press
releases and fact sheets can be found online at http://www.nhlbi.nih.gov.
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August 20th, 2004
Probability
of viremia among tissue donors in the United States
Source: www.gastrohep.com
The estimated probability of undetected
viremia at the time of tissue donation is higher among tissue
donors than among first-time blood donors, find researchers
in the latest issue of the New England Journal of Medicine.
Tissue-banking organizations have introduced
various review and testing procedures to reduce the risk of
the transmission of viral infections from tissue grafts.
In this study, researchers from the United
States estimated the current probability of undetected viremia
in tissue donors. They examined hepatitis B virus (HBV), hepatitis
C virus (HCV), human immunodeficiency virus (HIV), and human
T-lymphotropic virus (HTLV).
The team evaluated 11,391 donors at 5 tissue
banks in the United States.
They determined the rates of prevalence
of hepatitis B surface antigen
(HBsAg) and antibodies against HIV (anti-HIV), HCV (anti-HCV),
and HTLV (anti-HTLV).
The researchers then compared the data
with those of first-time blood donors to generate estimated
incidence rates among tissue donors.
They calculated the probability of viremia
undetected by screening at the time of tissue donation on
the basis of the incidence estimates and the window periods
for these infections.
The researchers found that the prevalence
of confirmed positive tests among tissue donors was 0.093%
for anti-HIV, 0.229% for HBsAg, 1.091% for anti-HCV, and 0.068%
for anti-HTLV.
They estimated the incidence rates to be
30.118, 18.325, 12.380, and 5.586 per 100,000 person-years,
respectively.
Furthermore, the estimated probability
of viremia at the time of donation was 1 in 55,000, 1 in 34,000,
1 in 42,000, and 1 in 128,000, respectively.
Dr Shimian Zou and colleagues concluded,
"The prevalence rates of HBV, HCV, HIV, and HTLV infections
are lower among tissue donors than in the general population".
"However, the estimated probability
of undetected viremia at the time of tissue donation is higher
among tissue donors than among first-time blood donors."
"The addition of nucleic acid-amplification
testing to the screening of tissue donors should reduce the
risk of these infections among recipients of donated tissues."
N Engl J Med 2004; 351(8): 751-9
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