| Back
to News Review
Alan Franciscus
Editor-in-Chief
Risk of HCV-Infected Allografts "Serious
Public Health Threat"
Living Donor Liver Transplants Offer Fewer Complications
Than Cadaveric Organs
Metabasis Therapeutics, Inc. Awarded a Two Year,
$2.4 Million Phase II SBIR Grant to Identify Hepatitis C Drugs
Treatment of Acute HCV Requires Expert Timing
Pregnancy May Have Beneficial Effect on Chronic
HCV Infection
Liver transplant recipients over 60 have lower
survival
State Develops Plan to Battle Hepatitis C
Vertex Pharmaceuticals Reports Six-Month Results
from Phase II Clinical Study of Merimepodib (VX-497) in HCV
Drug Earnings Look A Bit Sickly
Life on the Waiting List: Teacher Bides Precious
Time
Massachusetts Prisons Have High Disease Rate
Schering-Plough Gets EU Ok For New Pegintron
Label
New Mexico Inmates to Get Hepatitis Treatment
Pamela Anderson Says Hepatitis C May Kill Her
in a Decade
Fast-Track Review Speeds Japan Pegasys Approval
Laboratory Corporation of America. (LH) To Offer
Liver Fibrosis Assay HCV FibroSure™ Through Exclusive
Relationship With BioPredictive
Schering-Plough Posts Quarterly Loss, Sales
Fall
Tularik Receives FDA “Fast-Track”
Status
Is Acupuncture A Risk Factor For Hepatitis?
Health Officials Report Rise in Hepatitis C
$25 Million Settlement Offered Over Hepatitis
C Outbreak
Problems at Schering-Plough Run Deeper Than
Hassan Thought
EU Removes Requirement for Liver Biopsy For
Pegintron Patients
Possible Settlement of Lawsuits Reached in Hepatitis
C Outbreak
Schering-Plough Provides Grant Supporting Major
New Hepatitis C Research And Education Initiative By American
Academy of Family Physicians
Response to Standard Hepatitis C Treatment Can
Be Predicted As Early As Week 1
Schering-Plough Reports Novel Investigational
Protease Inhibitor
Researchers Identify Essential Component of
Immunity against the Hepatitis C Virus
New Drug Hope for Millions of Hepatitis C Victims
Shorter Interferon/Ribavirin Course Effective
for Chronic Hepatitis C Types 2 & 3
Study Shows 24 Weeks of Pegintron Combination
Therapy As Effective As 48 Weeks In Genotype 2/3 Hepatitis
C Patients
Efficacy in HCV Genotype 4: Unmet Need
Roche Study May Bring Wider Use of Pegasys Hepatitis
C Drug
New Study Investigates Pegasys and Copegus for
the Treatment Of Chronic Hepatitis C in African Americans
New Study Demonstrates Benefits of Hepatitis
C Therapy among Previously Under-Treated Patient Population
Idun Pharmaceuticals Reports Positive Data for
First Oral Clinical Trial in HCV Patients
Drug Hope for Hepatitis C
Pegasys Found Superior to Current Hepatitis
B Treatments
Cirrhotic Patients with Spontaneous Bacterial
Peritonitis
Cultures Of Human Fetal Hepatocytes
Idenix Pharmaceuticals Presents Positive 1-Year
Data On Telbivudine(LdT) For The Treatment Of Chronic Hepatitis
B
Management Of Hepatocellular Carcinoma Larger
Than 10 Cm
Severe Hepatitis C-Related Liver Damage Following
Liver Transplantation
Health-Related Quality of Life in Long-Term
Liver Transplant Survivors
Survival of Recipients Of Liver Grafts From
Donors Over 80 Years
Virus-Related Muscle Damage Tied To Chronic
Fatigue
Transplant Extends Survival in Liver Cancer
Patients
Designer Transplant Drug Shows Promise In Monkeys
Compound May Block Organ Rejection Without Side-Effects
October 15th, 2003
Risk of HCV-Infected
Allografts "Serious Public Health Threat"
Peggy Peck
Limitations in donor screening combined with outmoded donor
tissue sterilization procedures suggest that about 300 hepatitis
C virus (HCV)-infected musculoskeletal tissue specimens are
distributed by U.S. tissue procurement centers each year,
according to the results of a study presented here at the
41st annual meeting of the Infectious Diseases Society of
America.
Lennox Archibald, MD, medical director
of Regeneration Technologies in Alachua, Florida, said that
the Food and Drug Administration (FDA) currently "has
no approved test for postmortem presence of HCV in donor tissues.
Our research suggests that there could be up to 300 infected
tissue specimens distributed each year in the U.S. The multiple
infections this could cause in the recipient population “and
those who have contact with them — presents a serious
public health threat." Dr. Archibald supervised investigations
of allograft infection outbreaks while serving as a medical
epidemiologist with the Hospital Infections Program at the
Centers for Disease Control and Prevention from 1995 to 2002.
He noted that about 18,000 cadaveric donors
provide 650,000 allografts for transplantation often cartilage
for joint surgeries--each year. Thus, tissue from a single
infected donor could be distributed among dozens of recipients.
Serological tests used to screen tissue
donors for HIV antibody and hepatitis B virus (HBV) surface
antibody are very sensitive, but serology for HCV is not as
sensitive (97%), Dr. Archibald said. This is clinically worrisome
because data from first-time blood donors suggest that the
seroprevalence of HCV is markedly higher, 0.4%, than seroprevalence
of HIV (0.02%) or HBV (0.2%). Thus, he theorized that HCV
prevalence among tissue donors would also be higher. He said
an analysis of data from tissue procurement agencies suggests
that HCV is actually more common almost three times more common--among
tissue donors than among first-time blood donors.
In the study, Dr. Archibald and colleagues
obtained seroprevalence data collected from July 1996 to June
2001 from 39 U.S. tissue procurement agencies. HIV, HBV, and
HCV tests were performed on postmortem blood after standard
donor screening, which included medical/social history, physical
examination, and review of medical records. Positive HIV Ab
was confirmed by Western Blot, HBsAg by neutralization, and
HCV by recombinant immuno-blot assay.
Dr. Archibald used published anti-HCV
sensitivity data for clinical samples to estimate the annual
number of HCV-infected tissue donors that might not be detected
on initial screening.
The 39 agencies performed initial serology
on a total of 19,300 cadaveric tissue donors. That sample
represents about 21% of the tissue donors in the U.S. during
the same period. Seroprevalence rate for HCV Ab was 1.06%
compared with 0.03% for HIV and 0.29% for HBsAg, he said.
Thus, about five HCV-infected tissue donors
would be missed and 180 HCV-infected allografts distributed.
But that estimate does not include the number of tissue donors
that may be in the "window period" during which
serology would not detect infection. So a more accurate estimate,
he said, "is about 300 to 350 infected allografts each
year."
A sterilization procedure that included
viral inactivation would reduce this risk, but Dr. Archibald
noted that the FDA does not currently require that tissue
processors use such procedures.
"The significance of this study
is that, clearly, ongoing testing of cadaveric tissue does
not exist and this unique investigation has determined a significant
rate of hepatitis C infection among donors," Christopher
Woods, MD, director of the microbiology laboratory at the
Durham Veterans Administration Medical Center in North Carolina,
told Medscape. Dr. Woods was not involved in the study.
He added, "We can't underestimate
the importance of making sure that tissues that are being
transplanted into our desperately ill patients are, in fact,
healthy tissues. [This study] is a very important study."
Millions of people have been unknowingly
infected with hepatitis C, some of them from contaminated
blood during transfusions, according to health officials.
"We know that many people are infected
with hepatitis C and are unaware that they have the disease,"
said newly appointed US Surgeon General Dr. David Satcher.
"Unfortunately, many of them cannot
be readily identified because the disease does not cause symptoms
until it is far advanced."
"Many with hepatitis C virus have
no reason to believe they are infected," researchers
say. "Many of those at high risk are average people --
middle-aged housewives who had a cesarean section delivery,
young adults who had transfusions as high-risk babies or middle-aged
men who served in Vietnam."
It is believed that millions are infected
with hepatitis C by transfusions.
Hepatitis C is a potentially deadly disease
that infects the liver, causing extreme fatigue, nausea, loss
of appetite and abdominal pain. It can eventually cause cirrhosis
of the liver and death.
It is considered a silent epidemic because
many people don't develop symptoms for decades. The Centers
for Disease Control and Prevention (CDC) in Atlanta estimates
that 40 to 70 percent of those exposed to tainted blood become
infected with hepatitis C. Symptoms of Hepatitis C are nausea
and vomiting, weakness, fever, muscle and joint pain, yellowing
of eyes and skin, dark urine and tenderness in upper abdomen.
It is spread most commonly through intravenous
drug use, blood transfusions and organ transplants. It can
also be spread through sexual contact, although it is a less
likely means of transmission.
Satcher said that those who were infected
from contaminated blood transfusions could be tracked through
hospital and blood bank records.
An estimated 8,000 to 10,000 people die
from hepatitis C each year.
Back to top
Living
Donor Liver Transplants Offer Fewer Complications Than Cadaveric
Organs
by Megan Rauscher
Living donor liver transplantation (LDLT)
is associated with a lower rate of serious complications and
rejection and may have a slightly higher survival than orthotopic
liver transplantation, according to intermediate term morbidity
and mortality data from 92 patients who underwent LDLT at
the University of Rochester in New York between 2001 and 2002.
The study represents the largest single-center
study of LDLT in the U.S., Dr. Parvez S. Mantry told Reuters
Health. He presented the results Monday during the 68th Scientific
Meeting of the American College of Gastroenterology in Baltimore,
Maryland.
"From the donor standpoint, we published
data separately showingthat it is an extremely safe procedure,"
Dr. Mantry told Reuters Health.
In the current study, most recipients tolerated
the procedure "very well," he said, with 86% not
experiencing any significant complications, and the survival
rate was "pretty good," with 92% of patients alive
at 6 months.
"Although I published just the intermediate
term mortality, we are seeing that patients who underwent
LDLT even two or three years ago are for the most part doing
quite well," Dr. Mantry told Reuters Health.
The biliary and vascular complication rate
for the Rochester LDLT cohort (6.7% and 2.2%, respectively)
is lower than that reported nationally (22% and 9.8%, respectively),
the research team notes in a meeting abstract.
"The only condition where we have
to be a little watchful, and again that is evolving, is chronic
hepatitis C," Dr. Mantry said. "These patients may
have a higher morbidity from LDLT although that data is not
yet completely assimilated."
"LDLT, from my perspective as a hematologist,
is a very good alternative to cadaveric liver transplantation
mainly because the shortage of organs is so great," Dr.
Mantry said.
New York State has the largest waiting
list in the country but the least number of organs supplied
from cadavers so there is a "huge gap between supply
and demand," he explained, "which is why we like
to bank on living donor liver transplantation."
Dr. Mantry said he believes that LDLT is
"certainly going to catch on and will definitely be a
large part of liver transplantation in the future."
Back to top
October 16th, 2003
Metabasis
Therapeutics, Inc. Awarded a Two Year, $2.4 Million Phase
II SBIR Grant to Identify Hepatitis C Drugs
Metabasis Therapeutics, Inc. announced
today that it has been awarded a two year Phase II Small Business
Innovation Research (SBIR) grant of up to $2.4 million by
the National Institute of Allergy and Infectious Disease (NIAID)
entitled "Liver-Targeted Prodrugs for the Treatment of
Hepatitis C."
The grant supports research at Metabasis
focused on identifying potent, efficacious and safe drugs
for the treatment of hepatitis C patients using the company's
proprietary HepDirect(TM) technology.
The HepDirect technology is a prodrug technology
developed and patented by Metabasis that enables liver targeting
of the biologically active form of a wide variety of new and
existing drugs. Liver targeting can increase liver drug levels
and reduce peripheral exposure to the active compound and
thereby result in more effective and safe drugs for treating
liver diseases.
It is estimated that greater than 170 million
people are infected with hepatitis C worldwide. Despite recent
improvements in current therapies, a large segment of this
population is still not adequately treated. Nucleosides represent
a class of compounds commonly used to treat viral infections
such as hepatitis C. To date, however, few nucleosides other
than the marketed drug ribavirin have proven effective against
hepatitis C. Poor efficacy is attributed in many cases to
poor conversion of the nucleoside to the corresponding nucleoside
triphosphate, or NTP, which is the active form of the drug.
Metabasis believes its HepDirect technology can overcome this
limitation and lead to higher NTP levels in the liver while
simultaneously decreasing NTP levels outside of the liver,
which in some cases will result in improved safety.
Mark Erion, Executive Vice President of
Research and Development stated, "We are excited to receive
this award from NIAID. We plan to use the funding to expand
our nucleoside and HepDirect prodrug libraries, which we believe
will help us to identify new inhibitors of an enzyme important
for hepatitis C viral replication. The funding will also support
our efforts to further develop a cell-based screen that we
believe will provide information useful for selecting a development
candidate. Our HepDirect prodrug technology is being used
with Metabasis' drug candidates for hepatitis B and primary
liver cancer and we believe it will prove useful for targeting
drugs designed to treat hepatitis C infections to the liver."
Metabasis Therapeutics, Inc. (www.mbasis.com)
is a privately held, biopharmaceutical company that develops
proprietary products principally for the treatment of liver
and liver-related metabolic diseases. Metabasis has expertise
in the fields of nucleoside / nucleotide chemistry and metabolism,
liver biology and liver-specific drug delivery. Metabasis
has discovered and developed a new class of drug candidates
for treating diabetes that act to lower liver glucose production
in diabetic patients. The first drug candidate from this program,
CS-917, is being developed in collaboration with Sankyo Co.,
Ltd. and is currently undergoing clinical testing. Metabasis
has also developed its HepDirect technology that allows liver-specific
delivery of new and existing drugs. Two novel drug candidates
derived from the HepDirect technology are in clinical testing:
a drug for hepatitis B called Hepavir B, developed in collaboration
with Ribapharm, Inc., and a drug for primary liver cancer
called MB7133, to which Metabasis retains exclusive rights.
Back to top
Treatment
of Acute HCV Requires Expert Timing
Peggy Peck
If acute hepatitis C (HCV) is left untreated, a high number
of patients who are asymptomatic after exposure will spontaneously
clear the virus within two to four months of infection, according
to David Oldach, MD, from the University of Maryland School
of Medicine in Baltimore.
Dr. Oldach, who spoke during a symposium
on hepatitis C management controversies at the 41st annual
meeting of the Infectious Diseases Society of America, said
that one recent published report indicated that the clearance
rate in untreated individuals is "as high as 52%."
However, he said that waiting for the virus to clear spontaneously
can be problematic because if treatment is delayed too long,
it is unlikely that the virus will respond to therapy. The
issue boils down to this question, he said: "How early
is too early, and how late is too late?"
Given the high rate of spontaneous clearance,
Dr. Oldach said there are good data that suggest treatment
"before two to four months is probably too early."
He noted that for most patients treatment should follow "a
robust immune response" and he added that HCV-specific
proliferative responses are "necessary, but not always
sufficient for clearance [of HCV]."
He cited an ongoing University of Maryland
study of healthcare workers exposed to HCV through needle-stick,
which suggests that there are some factors that predict spontaneous
clearance of HCV: "Young females with symptomatic infection
are most likely to clear."
Just as treatment before two to four months
is too early, Dr. Oldach said that "if you wait to treat
until six months, you've probably waited too long." Studies
indicate that the likelihood of achieving a viral response
begins to decrease by six months. Thus, he said, treatment
should ideally take place between four and six months after
infection.
Once the patient and physician have agreed
that treatment is indicated, Dr. Oldach said the next issue
is "what therapy should be used?"
Most large studies were conducted in populations
with chronic infection, so there is little evidence to guide
treatment choices, he said.
Citing four studies that were conducted
in acute posttransplant HCV, Dr. Oldach said that high dose
5-10 million IU/day) interferon-alpha monotherapy for two
weeks followed by 24 weeks at standard dose (3 million IU
three times per week) achieved the most robust response. But
"the addition of ribavarin did not affect outcome,"
he said.
Raymond T. Chung, MD, associate professor
of medicine at Harvard Medical School in Boston, Massachusetts,
said that aside from acute HCV, a second difficult treatment
population is made up of patients who have HIV as well as
chronic HCV. With these patients, the clinician needs to determine
not only when and how to treat but also when and how often
to biopsy, because some data suggest that coinfection increases
the progression of fibrosis in the liver.
Dr. Chung said that he tracks fibrosis
by developing a fibrosis index that is based on the change
in fibrosis score between the first and second biopsy, divided
by the time between biopsies. When this index increases, he
recommends initiation of treatment.
Once treatment is initiated in coinfected
persons, Dr. Chung said that patients should be closely monitored
because "early viral response has a strong negative predictive
value. Thus, if the patient fails early, he or she is likely
to fail late."
When selecting an agent to treat coinfected
individuals, Dr. Chung said he recommends pegylated interferon,
which he said "should now be considered the standard
of care for coinfected individuals."
Eliot W. Godofsky, MD, assistant clinical
professor of medicine at the University of South Florida in
Tampa, said the difficult treatment decisions especially treatment
of coinfected individuals might be eased with "a noninvasive
test for markers of fibrosis." But Dr. Godofksy, who
chaired the HCV controversies symposium, said such tests were
"just in the investigational stage and clearly not ready
for prime time."
Back to top
Pregnancy
May Have Beneficial Effect on Chronic HCV Infection
Medscape
Pregnancy and parturition may enhance the natural resolution
of hepatitis C virus (HCV) RNA in women with chronic HCV infection,
according to a report published in the October issue of the
Journal of Medical Virology (J Med Virol
2003;71:205-211).
The findings are based on a study of 22
pregnant and 120 nonpregnant female patients infected with
HCV. Patients in both groups tested positive for anti-HCV
antibodies and for HCV RNA.
In the pregnant group, two women lost HCV
RNA permanently after parturition and one lost HCV RNA intermittently,
Dr. Masashi Mizokami, from Nagoya City University Graduate
School of Medical Sciences in Japan, and colleagues note.
In contrast, in the control group, one woman lost HCV RNA
permanently and one lost it intermittently (p = 0.03).
At 3 months after parturition, women who
lost HCV RNA were more likely than those with persistent HCV
RNA to have an HCV core protein level < 15 fmol/L (p =
0.02).
"The mechanism by which pregnancy
and delivery influence HCV viremia levels is not well understood,"
the authors note. However, it may be immune-mediated and result
from the post-delivery "rebound of the Th1 response after
Th2 shift during pregnancy."
Taken together, the findings suggest that
"pregnancy and parturition may improve the prognosis
in women with chronic HCV infection," they add.
Back to top
Liver Transplant Recipients over 60
Have Lower Survival
gastrohep.com
Older liver transplant recipients have lower survival than
younger patients, find physicians in the November issue of
the American Journal of Transplantation (Am J
Transplant 2003; 3(11): 1407-12).
Older age is not considered a contraindication
for liver transplantation. However, age-related morbidity
may be a cause of mortality.
In this study, physicians from Spain evaluated
survival and incidence of post-transplant complications in
111 adult liver transplant recipients.
The team divided patients into 2 groups
according to age:
Patients younger than 60 years (n = 54)
Patients older than 60 years (n = 57)
The doctors found that older patients were
more frequently transplanted for hepatitis C and hepatocellular
carcinoma. Their liver disease tended to be less advanced.
Malignancy as the cause of death:
Older patients = 21%
Younger patients = 2%
However, after transplantation these patients had significantly
lower survival, when compared to younger patients.
The team determined that higher age was
independently associated with mortality.
In addition, the incidences of de novo
neoplasia and nonskin neoplasia were
higher in older patients.
In this study, the team found that malignancy
was the cause of death in 2% of patients under 60 years, compared
with 21% of patients over 60 years.
Higher age and smoking were independently
associated with a greater risk of dying of de novo neoplasia.
Dr Ignacio Herreroa's team concluded, "Older
liver transplant recipients have a significantly lower survival
than younger patients".
"Malignancy is responsible for this decreased survival."
Back to top
State Develops Plan to Battle Hepatitis
C
The Hawaii Department of Health is releasing a newly developed
plan that addresses issues of surveillance, education, prevention
and treatment of hepatitis C, health officials said. "Because
of the similar risk factors between viral hepatitis, HIV and
sexually transmitted diseases, we have been working to develop
a program that integrates hepatitis prevention, particularly
hepatitis C, into existing public health department prevention
services and programs," said Peter Whitica, chief of
the department's STD/AIDS Prevention Branch.
Hawaii physicians and laboratories have
reported more than 5,000 cases of HCV since 1997, but since
the virus does not always produce symptoms, as many as 20,000
in the state could be infected, officials said.
Back to top
October 17th, 1003
Vertex Pharmaceuticals
Reports Six-Month Results from Phase II Clinical Study of
Merimepodib (VX-497) in HCV
Merimepodib Demonstrated Proof-of-Mechanism (Tolerability
and Clinical Activity) in Combination with Pegylated Interferon
and Ribavirin - Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX)
today reported encouraging results from a six-month interim
analysis of an ongoing Phase II clinical trial with its novel
drug merimepodib (VX-497) for the treatment of hepatitis C
virus (HCV) infection. This 31-patient study is designed to
evaluate the safety, tolerability and clinical activity of
merimepodib administered in combination with pegylated interferon
(peg-IFN) and ribavirin in HCV patients who were non-responsive
to treatment with a previous course of interferon and ribavirin.
At six months, merimepodib met its primary endpoint of safety
and tolerability and was not associated with any serious adverse
events. At six months, merimepodib also met its secondary
endpoint of clinical activity and demonstrated a statistically
significant antiviral response in combination with pegylated
interferon and ribavirin.
"In this six-month interim analysis, merimepodib was
well tolerated and showed a statistically significant dose-dependent
antiviral effect, suggesting that merimepodib may enhance
the antiviral activity of pegylated interferon and ribavirin,"
stated John J. Alam, M.D., Senior Vice President of Drug Evaluation
and Approval. "Based on the tolerability and clinical
activity of merimepodib observed in the interim analysis of
this study, we believe proof-of-mechanism for merimepodib
in treatment-refractory patients has been obtained. The complete
analysis, which will include 12-month treatment and six-month
post-treatment data, will be used to guide the clinical path
of merimepodib going forward."
"Within the limitations of the size
of this study, we are encouraged by the tolerability and additive
antiviral activity that merimepodib demonstrated in patients
who were non-responsive to previous combination therapy,"
stated Dr. Patrick Marcellin, Professor of Medicine at University
of Paris VII, and the lead investigator for the study. "The
main goal of HCV treatment is to clear the virus
from patients. The addition of merimepodib to a standard-of-care
regimen appears to increase the proportion of treatment-refractory
patients who show a viral response at six months, representing
a clinically important finding. "
Study Design
The Phase II, double-blind, placebo-controlled, randomized
study is designed to evaluate the safety and tolerability
of two dose regimens of merimepodib in combination with peg-IFN
and ribavirin in patients with HCV genotype 1 who were non-responsive
to interferon-alpha and ribavirin therapy. The secondary objective
of the study is to assess the pharmacokinetics and clinical
activity of merimepodib. The study is being conducted in Europe.
Patients enrolled in the
study had previously received a minimum of 12 weeks of IFN
and ribavirin treatment without achieving undetectable viral
RNA (vRNA)at any time point. After the initial six months
of the trial, patients had the option to extend treatment
for an additional six months. Collection of 12-month end-of-treatment
data and six-month post-treatment sustained virologic response
data is continuing.
Vertex anticipates that when the study is complete, the full
trial results will be presented at a medical conference.
Merimepodib is one of several drug candidates
in Vertex's product portfolio that the Company is developing
independently in the areas of infectious disease, autoimmune
disease, inflammation and genetic disorders. Based on results
from ongoing studies, as well as an analysis of market opportunity,
Vertex expects to prioritize two drug candidates from this
portfolio for full development and
commercialization in high-value markets served by specialists.
At the same time, Vertex will continue to pursue strategic
alliances to maximize the near-term and downstream commercial
value of certain research and clinical development programs.
Vertex currently retains all worldwide development and commercial
rights for merimepodib.
About Merimepodib
Merimepodib is a small molecule, orally administered inhibitor
of the enzyme inosine monophosphate dehydrogenase (IMPDH).
IMPDH inhibition leads to a reduction in intracellular guanosine
triphosphate (GTP), a molecule required for DNA and RNA synthesis.
Recent reports in the medical literature
suggest that IMPDH inhibitors such as merimepodib may enhance
the antiviral activity of ribavirin in vitro by depleting
GTP and increasing the rate of incorporation of ribavirin
into viral RNA, rendering the virus nonfunctional (1). These
insights provide a mechanistic interpretation for the antiviral
activity observed clinically when merimepodib is added to
ribavirin-containing HCV therapies. IMPDH inhibition may therefore
represent an attractive strategy for increasing the sustained
viral response rate in HCV patients, the principal goal of
treatment.
Previous Studies of Merimepodib
Merimepodib has been evaluated in two previous short-term
studies in HCV patients. Vertex previously reported data from
a 28-day Phase II study to evaluate the safety, tolerability
and clinical activity of merimepodib combined with interferon-alpha
in treatment-naive HCV patients. The viral load data from
this study showed a trend toward enhanced antiviral activity
in patients treated with merimepodib combined with interferon
as compared to patients receiving interferon alone.
Vertex has also conducted a 28-day Phase
II study of merimepodib administered as a monotherapy to HCV
patients who were non-responsive to prior treatment with interferon-alpha.
Results from this study showed that merimepodib was well tolerated
and appeared to reduce levels of serium alanine aminotransferase
(ALT), a marker of liver inflammation.
About HCV Infection
HCV infection is a serious disease that causes inflammation
of the liver, which may lead to fibrosis and cirrhosis, liver
cancer, and ultimately, liver failure. Chronic hepatitis C
infection afflicts approximately 2.7 million people in the
U.S., many of whom are unaware of their infected status. HCV
may go undetected for up to 20 years following initial infection.
Worldwide, the disease strikes as many as 185 million people.
Each year, 8,000 to 10,000 people in the U.S. die from complications
of HCV. Current treatments have been effective for only 40
to 60 percent of patients chronically infected with genotype
1 HCV, the most difficult viral strain to treat and the most
common form in the U.S. Patients who are non-responsive to
current HCV therapy have limited treatment options, and clinical
experience shows that only a very low proportion of such patients
achieve a sustained viral response with subsequent treatment
regimens.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology
company committed to the discovery and development of breakthrough
small molecule drugs for serious diseases. The Company's strategy
is to commercialize its products both independently and in
collaboration with major pharmaceutical partners. Vertex's
product pipeline is principally focused on viral diseases,
inflammation, autoimmune diseases and cancer. Vertex's first
approved product is the HIV protease inhibitor Agenerase (amprenavir),
which Vertex co-promotes with GlaxoSmithKline.
Vertex Safe Harbor Statement
This press release may contain forward-looking statements,
including statements that i) that merimepodib may enhance
the antiviral activity of pegylated interferon and ribavirin;
ii) that proof-of-mechanism has been obtained based on interim
data from Vertex's clinical study; and iii) that Vertex will
prioritize two drug candidates from its portfolio for independent
development and commercialization in high-value markets served
by specialists. While management makes its best efforts to
be accurate in making forward-looking statements, such statements
are subject to risks and uncertainties that could cause Vertex's
actual results to vary materially. These risks and uncertainties
include, among other things, the risk that i) the six-month
interim analysis of the study may not be indicative of the
12-month analysis; ii) data suggesting proof-of-mechanism
may not be confirmed by 12-month data, or the results of this
small Phase II study of merimepodib may not be indicative
of the results that would be obtained in a larger trial; iii)
Vertex's drug development programs may not proceed as planned
due to partnership, technical or patient enrollment issues,
and other risks listed under Risk Factors in Vertex's form
10-K filed with the Securities and Exchange Commission on
March 31, 2003.
Agenerase is a trademark of the GlaxoSmithKline
group of companies.
(1) Zhou, S. et al. (2003) The effect of
ribavirin and IMPDH inhibitors on hepatitis C virus subgenomic
replicon RNA. Virology 310: 333-342.
Vertex Contacts:
Lynne H. Brum, Vice President, Corporate Development and Communications,
(617) 444-6614
Michael Partridge, Director, Corporate Communications, (617)
444-6108
Jaren Irene Madden, Media Relations Specialist, (617) 444-6750
Back to top
October 17th, 2004
Drug Earnings
Look A Bit Sickly
Ed Silverman
Just a few years ago, drug stocks were treated like gold.
And for good reason.
Since the results of drug companies aren't
tied to economic cycles, the industry was viewed as a nice
hedge against a soft economy. Moreover, billion-dollar sellers
were still streaming out of many labs.
Not anymore.
This year, the pharmaceuticals group is
likely to generate earnings growth of just 0.9 percent, half
of last year's performance, according to Michael Krensavage,
an analyst at Raymond James.
"Many of the big names have been left
behind in the rally since last spring," said Brandon
Carl, an analyst at BB&T Asset Management. "Basically,
a lot of people are worried about competition from generic
drugs."
Investors will get a glimpse of how the
major drug companies are faring this week when Merck, Pfizer,
Schering-Plough, Wyeth and Bristol-Myers Squibb report third-quarter
earnings. Johnson & Johnson last week posted a 20 percent
increase in profit, though it acknowledged it is in a cost-cutting
mode.
Between them, these companies form the
heart of the U.S. drug industry and employ tens of thousands
of people in New Jersey.
The biggest drag on the sector is Schering-Plough,
which last year lost patent protection for Claritin, the allergy
medicine, and faces increased competition for its hepatitis
C treatment. Recently, the Kenilworth drug maker announced
a restructuring.
But the subsequent arrival of cheaper generics
is the big reason the company is expected to report third-quarter
earnings of 10 cents a share, a 66 percent drop compared with
the previous year, Krensavage said.
By the same token, Schering-Plough shares
have been battered for so long that Tim Anderson, an analyst
at Prudential Financial, said he believes the company is undervalued,
at least for the longer term. In particular, he points to
sales potential for Zetia, a cholesterol drug.
Schering-Plough "should be one of
a small handful of pharmaceutical stocks with naturally occurring
revenue and earnings growth," he wrote in a note to clients.
"This growth will likely be driven largely by Zetia,
and a (planned) combination of Zetia and Merck's Zocor."
The outlook for Merck, by contrast, is
less certain. The Whitehouse Station drug maker recently spun
off Medco Health Solutions, the pharmacy-benefits manager,
which means investors will see earnings from Merck reflecting
a pure pharmaceuticals entity.
But Merck faces concern about the prospects
for cholesterol drug Zocor, its biggest-selling medicine.
Year-over-year sales are expected to decline, according to
Anderson. Meanwhile, Zocor faces generics in other countries
and the recent launch of AstraZeneca's Crestor here.
"We remain skeptical on Merck, because
prescription data suggest the company needs accelerated sales
to hit its earnings growth target of 10 percent this year,"
wrote Krensavage, who looks for Merck to report third-quarter
earnings of 83 cents, up 6.4 percent.
He added Merck prescriptions filled through
retail and mail-order pharmacies fell 9.5 percent through
August, and dollar-valued sales rose 1.3 percent, citing data
from NDC Health, a market-research firm.
Similarly, analysts are cautious about
Pfizer, which sells Lipitor, the leading cholesterol treatment,
because of fresh competition. There is also a potential rival
for Viagra, another big seller. Krensavage looks for earnings
of 38 cents, down 4.5 percent from a year ago.
On an upbeat note, Krensavage said he forecasts
Bristol-Myers Squibb will report an 11 percent increase in
earnings, to 41 cents. The performance is mostly due to the
poor showing a year ago, but also strong results from treatments
for HIV and schizophrenia.
Wyeth is expected to report third-quarter
profit of 55 cents, up 17 percent, said Krensavage, whose
forecast is 5 cents less than the consensus of other drug-industry
analysts. The bright spots include rising sales of a heartburn
drug and an anti-depressant.
But declining sales of hormone replacements,
which have been linked to cancer, continue to plague the Madison-based
drug maker. He expects sales of the Premarin product line
to show a sales drop of $285 million, or 32 percent, from
a year ago.
Back to top
Life on
the Waiting List: Teacher Bides Precious Time
by Jack Slater
That Saturday morning was pleasant— almost too pleasant.
It was May 26, 2002. My wife and I were in our kitchen in
Ballard, about to make a batch of gazpacho to welcome the
coming summer. I was holding a tuna-salad sandwich, wrapped
in plastic, which I had just bought at the corner store.
We heard the rattle of the mailbox, so I went downstairs,
sandwich in hand. I opened the mailbox door and there it was—the
letter I had been expecting for almost two months. I pulled
it out and stared at the envelope. It seemed to glow in my
hand. I kissed it and said a quick prayer for the hope it
had to offer. For it to say I had been placed on the waiting
list for a liver transplant.
I HAVE HEPATITIS C, a nasty, blood-borne virus that attacks
the liver,eventually killing it and the person in whom the
liver resides. By that May morning, I had endured six months
of tests in one of life’s more ironic contests: trying
to prove I was healthy enough to earn my place in line for
a donated organ.
The only known treatment for “hep C” involves
daily injections of interferon. The side effects are nasty
and the cure rate is roughly 20 percent. My disease is sufficiently
advanced to make the odds of a cure much lower and the harsh
treatment not worth the odds. Now my only hope is if somebody
out there dies the right kind of death: one that leaves the
liver intact. The person who dies needs to be healthy—and
needs to die when I’m healthy enough to be approved
for, and survive, a grueling surgery. The person needs to
have my blood type, be about my size and have had the foresight
and kindness to register the desire to be an organ donor.
Of course, I wish you a long and happy life. But if that doesn’t
happen, well, someone out there could use your lungs, heart,
valves, eyes, skin, bone, tendons, kidneys and liver. It’s
an amazing world we live in.
I HAD NO SYMPTOMS when I was diagnosed with hep C in 1997.
That same year I was hired to teach history at Seattle’s
Franklin High School, a job that brought my life full circle.
I learned the gift of gab selling men’s shoes at my
father’s store in West Palm Beach, Fla. I was a history
and education major in college and taught adult ed for a year
before I hit the road, Jack Kerouac style. I stumbled into
acting, which I did for 20 years: movies, television, commercials,
a bit of stand-up political humor. It was fun while it lasted,
but no way for a grown man to live. I had long harbored this
notion of moving to Seattle, where I could drink good beer
at the Virginia Inn and play softball at Green Lake. And in
1991, I did just that, after falling in love with the woman
who has been both my dream and my wife for 12 years. After
teaching at the King County Jail and as a substitute teacher
in the Seattle schools, I landed this great gig at Franklin.
Teenagers are fun and exasperating and bored by un-hip education.
Reading is slow; computer games brilliantly quick. It doesn’t
help that many parents are chronically broke or that many
teachers are close to broke.
But teaching has its perks. It feels righteous to chaperone
the prom. We hear great concerts by the jazz band and see
wonderful stage productions. We see talented kids mature and
add a few inches from year to year. We miss them when they
graduate.
Teaching history has been made even more exciting by world
events. Each day, it seems, the front page offers earthshaking
news that can be connected to the culture, social movements
and wars of the past, that connects people in the Middle East,
Korea and Texas. Every chance I got, I taught African-American
history. It’s in our face every day. We must learn it
well. All of us.
So when I was told I had hep C, I quit drinking ‘doctor’s
order’ and poured myself into teaching. For almost five
years, I was happy and symptom-free.
THEN, IN LATE 2001, I GREW TIRED. Impossibly tired. School
starts at 7:45 a.m.; I had trouble getting out of bed in time.
Driving home after school, I found myself dozing at red lights.
A medication I was taking sent me on frequent trips to the
bathroom; it’s not cool to be late for class or to leave
in the middle.
By May 2002, I had to stop working. I was calling in sick
too often to be any good to my students. I had trouble reading.
Grading papers took more energy than I could muster. I had
grown pale and thin and suffered bouts of encephalopathy:
toxins, not processed by my failing liver, lodged in my brain,
resulting in bizarre behavior, like peeing on the floor, and
ambulance trips to the hospital of which I have no memory.
My muscles began to atrophy. I was no longer the mighty force
on my over-40 softball team or a dazzling dinner-and-dance
partner.
I excused myself from a dinner party once to lie down for
a bit. When my friends woke me four hours later, I didn’t
know where I was and barely knew who they were, so they took
me to the hospital, where the doctors gave me some medicine
and asked if I could name the president and my wife’s
birthday. I insisted—wrongly—that her birthday
was the same as mine. But as a way-left liberal, I am obsessed
with George W. Bush, so the president question was a no-brainer
even for a person temporarily deprived of his brain.
For five years, my condition had seemed little more than background
noise. Now it reared up as what it really was: end-stage liver
disease. I experienced nausea, cellulitis (which turned my
lower left leg black), severe fatigue, swollen abdomen, legs
and groin. Not all at the same time, and not in any pattern
I could predict. The only thing predictable about the course
of hep C is that it’s downward.
I figured I was an excellent candidate for a transplant. I
am not a smoker. I had negative colonoscopies and endoscopies.
I breezed through the blood tests, CAT scans, DEXA scans and
echocardiograms. I presented myself to the hospital’s
social worker as an emotionally stable person with a wife
and friends who would provide round-the-clock care for two
to three months after the surgery. And I have insurance: Transplant
surgery costs upward of $350,000. There would be a light at
the end of this very dark tunnel. I was in a hurry to get
to it.
SO IT WAS THAT WARM MORNING IN MAY 2002, standing at the mailbox,
tuna sandwich in one hand, my future clutched in the other.
The letter fairly vibrated in my hand. I opened it slowly
as I made my gimpy way back upstairs to the kitchen. The refrigerator
door stood open and my wife stood over a mound of minced tomatoes.
I read the first line.
“We regret to inform you ... “
I flung the letter at my wife and let out a roar like unto
death itself. I threw the sandwich into the refrigerator as
hard as I could. I wanted—needed—the atavistic
thrill of exploding tuna.
But I was denied even that small satisfaction. The sandwich
shot past the bottles and jars and Tupperware and landed neatly
in its plastic wrap. I should count myself lucky, because
once you start wiping up great wads of tuna salad from the
walls of your refrigerator you might as well clean the whole
dang box. That’s too wretched a task even on the best
day of your life. I wanted to pick up the refrigerator itself
and hurl it out the window. Maybe I could hire three or four
guys from the Millionair Club to heave it through the window
for me. Nothing less would express how rotten I felt. I was
dying of a monster blood virus and I didn’t want anything
but my rightful place in line for some poor, dead guy’s
liver that would otherwise go to waste.
Maybe I should go to Spain where there are no motorcycle-helmet
laws and livers aplenty. The waiting list here is very long.
Whenever a state decides to make motorcycle helmets mandatory,
organ donations plummet. Other things conspiring against me:
a drop in gang violence, lower speed limits in Montana, people
mellowing out through meditation and yoga, automobile air
bags and the Department of Homeland Security.
This kind of thinking leads to madness. Let it go, let it
go. I PICKED UP THE LETTER. It said I was not good transplant
material because, over the course of my life, my use of alcohol
was considered excessive.
What? I hadn’t had a drink in five years. Even in my
younger, wilder days, booze wasn’t a big deal. Sure,
I enjoyed my beer. But beer with pizza after a ballgame isn’t
drinking, it’s a picnic. Wine with dinner? Of course.
But never had a DUI. Never had an accident.
I asked the transplant folks to define “excessive.”
Their answer: Drinking more than one glass of wine a week,
smoking or using any illegal drug was a sign of chemical dependency.
I begged to differ, so I was sent to a specialist who determined
that, in fact, I was not chemically dependent. I now have
an official paper stating that I am not an alcoholic or a
drug addict. Do you? I’m like the guy who gets released
from the mental hospital and is given a paper saying that
he is no longer “mental.” He has proof he’s
not crazy. Do you?
It made no difference to hospital officials. They asked that
I attend Alcoholics Anonymous meetings for six months and
submit to random urine tests to see if I could “handle
this pressure-packed time without resorting to drinking, smoking
or using illicit drugs.” I felt like they were robbing
six months of my life—and daring me to fail.
But they have their rules. And I have this lousy liver. So
I went to AA. It was pretty good. The people I met there were
caring, thoughtful and intensely honest. When I finally gathered
the courage to speak at a meeting, I suggested that part of
the reason we drink is because we are awash in media fairy
tales of relentlessly happy couples sipping cocktails on virgin
beaches or of beautiful women who will be your pal for the
night if you just drink the right beer.
I was shouted down. In AA, there are no excuses. Just tell
your story and sit down.
That’s what I did. And on the day before Thanksgiving
wonder of wonders and hallelujah!—I was welcomed onto
the transplant waiting list.
They gave me a pager. I felt halfway cured.
IT’S BEEN ALMOST A YEAR. There is no way to know when
a liver will show up with my name on it. I need to be good
to go at all times. Think about it: I could be talking on
the phone with my parents in Florida and—beep! beep!—my
pager goes off and life changes forever. They’ll just
have to hold their breath, take a long walk and pray until
the next phone call.
A few hours later, I will emerge with a pre-owned liver and
a regimen of expensive medicine, frequent hospital visits
and unpleasant complications.
Everyone has complications. And I will always have hep C,
but my new liver will buy me some time before it, too, becomes
diseased. The oddsmakers give me an 85 percent chance to make
it a year; 67 percent to make it five years.
But that all presumes I survive surgery.
What if there’s a problem with the anesthesia or an
infection or some simple mistake? Maybe I should write in
permanent marker on my stomach—LIVER RECIPIENT!, along
with my Social Security number and blood type—just in
case.
What if my body rejects the liver? What if people bring me
balloons with Tweety Bird on them?
I had polio when I was 6. We were living in Chicago then,
and I was sent to a hospital for what seemed like months.
I remember thinking the nurse, Miss Tripp, was mean and that
hospitals were such sad places.
They still feel sad to me: the matter-of-fact doctors and
their eager interns; the janitors who scrub the floors and
don’t make eye contact; the guy in the next bed who
watches dopey TV shows; the awkward visits by his relatives
and minister. We, the sick, look at those who are not as if
they won the lottery and we won the wheelchair. Even the floor-moppers
have it better than we do. Oh, to be able to mop the floor.
For months after I got sick, I divided the world into those
who have hep C—namely, me—and the rest of the
world. I felt bitter, alone and alienated from all that is
fun, beautiful and tender. It must be how combat veterans
feel. They know things that they don’t want to talk
about and we don’t really want to know. I live in my
own little combat zone and I am the walking wounded.
It took months before I told more than five or six friends.
This disease is common among drug addicts who use needles.
I could imagine minds at work, speculating, judging. I really
am not certain how I got it. And once you have it, the how
doesn’t much matter. So now I tell everybody. Let them
speculate. Let them judge. As if one dying man is more tragic
than another.
PEOPLE SAY I AM BRAVE, and ask how I manage. I have no good
answer.
I accept that I am living and dying on the edge of limited
time. Aren’t we all? But I have made no pledge forswearing
self-pity, anxiety, anger or depression. Expressions of love
from my wife get me through the hard days. Being sick and
alone has got to be the worst. I urge you to visit, write
a note or make a call to the sick and shut-in. Just to say
hi. Someday you will be grateful for the same.
All my life, I’ve been blessed with a light heart and
a positive attitude. I love James Thurber, P.G. Wodehouse,
Mark Twain and the cartoons in The New Yorker. I love Laurel
and Hardy, Erma Bombeck, Monty Python, Lenny Bruce, Richard
Pryor, Bill Cosby and “Catch-22.” I own a whoopee
cushion, a red nose and a beanie with a bicycle horn glued
on top. I once worked as a street clown with a group called
Free Public Laughs in Chicago.
Every time I laugh, I feel my guts being bathed in milk and
honey and my mother’s chicken soup. Sometimes I’ll
bump into one of my wise-guy friends and he’ll say,
“Hey! You’re not dead yet?” It’s OK.
I laugh. I laugh at this rotten disease and curse it, rip
out its throat and kick it down the stairs. And then I laugh
some more. Laughter is strong and it heals. There is scientific
proof. Read Norman Cousins’ “Head First: The Biology
of Hope and the Healing Power of the Human Spirit.”
Read “Laughter is the Best Medicine” in Reader’s
Digest. Need I say more?
My wife and I are blessed with friends who overwhelm us with
their generosity. They help pay insurance premiums and bring
us homemade meals on wheels. They give us tickets to the opera
and ballgames. Two friends work through our combined Rolodexes
each month, encouraging small gifts of cash and time. Former
students send wall-sized sheets of paper scribbled with good
wishes and poems. One student wrote “To Mr. Slater.
R.I.P.” He wants me to Rest. In Peace. If it sounds
right to him, it sounds right to me.
I was never one to send teddy bears, books or blankets in
the wake of hurricanes, earthquakes or bombings. Bless those
who do. I shall join their ranks. For this is my earthquake.
I must take the pills, exercise, rest, laugh frequently and
start sending those teddy bears, and whatever else the Red
Cross says it needs. LIKE YOU, I’M NOT READY TO DIE.
And this wasn’t supposed to happen to me.
If there was any justice in the world, surviving polio should
have given me a pass on dramatic diseases for the rest of
my life. It left me with a slight limp, but it exempted me
from the draft during the Vietnam War. I’ve lived an
active life but am not a thrill-seeker. A comfortable chair
and a good book are always preferred over activities requiring
helmets, snowshoes or even golf clubs. And in 1997, when I
was 51, I did the right thing and got my over-50 physical.
Two days later, the doctor called to order a follow-up visit.
I imagined a stern talking-to about prostate cancer and cholesterol
levels. Turns out those things were fine. But my blood and
enzyme numbers showed I had end-stage liver disease. Then
the doctor explained what “end-stage” means.
Here I was doing all the right things—teaching school,
building community, staying healthy, getting a physical—and
I get a fetid pie thrown in my face.
I left the office and drove to Alki Beach. It was raining,
and I was grateful for that. A beautiful day would have been
like a slap in the face. I remember the gloriously wretched
smell of low tide. I sucked in the smell of the rotting sea
world. Misery loves wretchedness.
So this is how it’s going to happen for me. A long,
daily death. I’ve had a few friends die of AIDS, a few
of cancer, a couple by suicide and one from hang gliding.
Now it’s my turn?
A SLOW-MOTION DEATH IS NOT HOW I IMAGINED my life would be,
or cease to be. It allows for too much contemplation. I prefer
to “be here now.” Big questions of cosmology and
cosmogony are best left alone. But these days, I can become
obsessed by death. I could die on the surgery slab, an actor’s
last scene in an operating “theater.” Or l could
be one of the 2,500 sick folks who die each year waiting for
a new liver.
And of course there’s still time to be run over by a
truck. At Alki that day, and many times since, I have found
myself confused, sad and defeated, alone with my whoopee cushion
and James Thurber. I imagine conversations that go like this:
Say, Leroy, did you hear that Slater died?
No kiddin’? Man, Slater was a real stand-up guy.
Yes, he was good people. I’ll miss him.
Yeah, me too. Listen, I’m kinda hungry. You wanna get
somethin’ to eat?
Yeah, sure. Let’s go.
That’s how it is and how it’s always been. How
soon they forget. So I imagine my funeral and hope that people
tell the best stories about me and describe me well in all
my complexity. I think the wake should continue for about
a week. If I have any money left, I’ll leave it for
the catering. Lay me in a hammock with my arms folded behind
my head and the ballgame on the radio. Or bury me in a plain
box under some rosebushes to atone for my sometimes lazy approach
to recycling.
My brother says he plans to defy the maxim that says you can’t
take it with you. He wants me to dig a big hole and put him
and all his possessions in together. I will do it for him
if he gets run over by that truck before I do.
I don’t care much about material things. But what about
all my book learning, street smarts, good intentions, the
search for meaning, the love received? It seems like such
a waste to have it thrown in the grave with me. Any love I
have given I know will last forever. There is comfort in that.
Too much time at the office? Not I. I was dancing, singing,
having dinner parties, making art, planting a garden.
So why me? Is there a cosmic reason? Or is it just my time
to get out of the way and free up a parking space?
The answer is there is no answer. Just suffering and, if you
are lucky, meaningful work, good friends, a few opportunities
to love and time to plant tomatoes.
IF I SOUND HOPELESS AND GRIM, keep in mind this is not some
treatable case of prostate cancer. This is me falling down
on the sidewalk and bleeding to death because my blood will
no longer coagulate (highly unlikely except in my overworked
imagination). I look for hope, laughter and love in the neighborhood
of my heart, but I live in the shadow of the valley of death.
I look at my neighbors in Ballard, and they give me joy and
tuna casseroles. About a week after Sept. 11, 2001, I was
scanning the shelves of the Elliott Bay Book Co. Few of the
titles seemed relevant to this new world reality. How could
I buy a book about the Civil War or the flowers of the Sahara?
Here we were, alive in Seattle, trying to understand why some
3,000 of us were dead in New York. A generation of war was
soon to come and attention must be paid. We are on red alert
every day.
In some ways, this world in turmoil has taken the pressure
off me. Now we all have a dis-ease. We are all targeted. Every
lone lunch bucket on the sidewalk warrants a call for the
bomb squad. I feel the same way every time I have a nosebleed.
LAST YEAR, MY DOCTOR TOLD ME I HAD TWO TO THREE YEARS LEFT
to live
with my diseased liver. I said, “WHAT?” He said
three years is a long time. He is from a country where the
average life expectancy is 57 years.
I am 57.
My doctor is a good man and I have come to like him enormously.
I reminded him that in this country, we spend billions on
medical research and have the best of everything at least
those of us with insurance and expect to live very long lives.
I said that in three years, this country will see a whirlwind
of change and I want to be there for it. I want to see if
they discover weapons of mass destruction in Iraq. I want
to see the Mariners win it all someday. I have planted a small
star jasmine whose vine will grow slowly and produce enough
blossoms that will waft sweet springtime delight into our
bedroom. That will take at least six to seven years. The doctor
smiled and said, “I understand. But you have hepatitis
C.”
On the drive home, I threw up. It wouldn’t be the last
time.
Jack Slater is on a medical leave from the Seattle Public
Schools, where he teaches history. He was born in Chicago,
graduated from Calvin College in Michigan and worked for 20
years as an actor and humorist. He has been a community and
political activist and is an avid artist and gardener. He
lives in Ballard with his wife, Deborah Swets, the executive
director of CityClub. You can reach him at jslater@sseattletimes.com
*Seattle Times photographer Alan Berner can be reached at
206-464-8133 or aberner@seattletimes.com
*To reach an editor about this project, contact Jacqui Banaszynski
at 206-464-8212 or jbanaszynski@seattletimes.com
Copyright 2003 The Seattle Times Company
Back to top
October 20, 2003
Massachusetts
Prisons Have High Disease Rate
Massachusetts prisoners have some of the highest rates of
infectious disease in the country, according to a study slated
to be released next week.
Citing a study from the Massachusetts Public Health Association,
The Boston Globe reported that Massachusetts inmates have
the seventh-highest rate of HIV infections in the nation.
And 44 percent of women and 27 percent of men were diagnosed
with Hepatitis C according to the report.
Disease specialists theorized that the higher rate of intravenous
drug use in the Northeast could be part of the cause, the
Globe reported.
Researchers and others have called for health care improvements
for parolees so that they will not infect the communities
they return to after serving their sentences.
Much of the problem is related to substance abuse, Dr. Alfred
DeMaria, the state's director of communicable disease control,
said.
"Substance abuse is clearly the predominant risk factor,"
DeMaria said.
"And if you look at the pattern of imprisonment in this
country over the years, drug crimes are drawing longer and
longer sentences."
Back to top
October 21st, 2003
Schering-Plough
Gets EU Ok For New Pegintron Label
Schering-Plough Corp. said Tuesday that the European drugs
regulator has approved a new label for chronic hepatitis C
treatment PegIntron Injection.
Schering-Plough Europe said that the European Agency for the
Evaluation of Medicinal Products, or EMEA, has approved a
new label for PegIntron (peginterferon alfa-2b) Injection,
the most-prescribed interferon treatment for chronic hepatitis
C.
As noted in the new label, patients are no longer required
to undergo liver biopsy to confirm diagnosis of hepatitis
C and to indicate the potential for treatment impact.
Traditionally, liver biopsy in patients with chronic hepatitis
C has influenced treatment decisions and has been used during
treatment to determine whether the disease has stabilized
or progressed. The revised PegIntron label clarifies for physicians
that a biopsy may not be necessary if a decision to treat
has already been made based on other factors.
For example, the EMEA noted that, since the viral eradication
rate is high (88 percent) for patients with hepatitis C genotype
2/3 virus taking PegIntron and Rebetol (ribavirin) combination
therapy, treatment is often indicated even if the biopsy turns
out to be benign. “Many patients have been put off by
the idea of undergoing an invasive procedure like liver biopsy,”
said Thierry Poynard M.D, Ph.D., Professor of Medicine, Groupe
Hospitalier Pitie-Salpetrier, France. “The new PegIntron
label eliminates a barrier to treating patients at risk for
hepatitis C. This is an important step in fighting this serious
disease.” PegIntron is a longer-acting form of Intron
A (interferon alfa-2b, recombinant) Injection that uses proprietary
PEG technology developed by Enzon, Inc. of Bridgewater, N.J.,
USA.
PegIntron, recombinant interferon alfa-2b linked to a 12,000
dalton polyethylene glycol (PEG) molecule, is a once-weekly
therapy dosed according to patient body weight that is designed
to achieve an effective balance between antiviral activity
and elimination half-life. Schering-Plough holds an exclusive
worldwide license to PegIntron. Rebetol is an oral formulation
of ribavirin, a synthetic nucleoside analog with broad-spectrum
antiviral activity.
It is approved worldwide for use in combination with PegIntron
or Intron A for the treatment of adult patients with chronic
hepatitis C. Schering-Plough has rights to market oral ribavirin
for hepatitis C in all major world markets through a licensing
agreement with ICN Pharmaceuticals Inc. of Costa Mesa, Calif.,
USA.
Chronic hepatitis C is estimated to affect more than 10 million
people in major world markets. In Europe, chronic hepatitis
C is a leading cause of chronic liver disease and one of the
most common reasons for liver transplant.
Schering-Plough Europe, based in Brussels, Belgium, is
a country operation of Schering-Plough Corporation of Kenilworth,
N.J., USA.
Back to top
New Mexico
Inmates to Get Hepatitis Treatment
AP
New Mexico for the first time will began treating prisoners
for hepatitis C, a virus that infects about a third of the
state's 6,200 inmates.
A new generation of medicines that can effectively treat the
virus was not developed until about two years ago, said Dr.
Frank Pullara, medical director for the state Corrections
Department.
Hepatitis C, often contracted through intravenous drug use,
can destroy the liver in a small percentage of those who get
it.
Treatment can range from $15,000 to $30,000 per patient. However,
Pullara said that's only a fraction of the $500,000 price
tag of a liver transplant which the state likely would have
to pay for if an inmate needed it.
"What we want is to catch those people who are going
to have significant damage to their livers if we don't treat
them,'' Pullara said. "If we don't intervene now, sooner
or later, they're going to get into trouble."
A small group of inmates will begin a regimen of pills and
shots, Pullara said.
Four will be undergoing treatment by next week, said Pullara,
a University of New Mexico School of Medicine liver disease
specialist who along with other medical experts developed
a protocol for treating inmates for hepatitis C.
Most people with hepatitis C don't become seriously ill. Pullara
said many with the virus don't even know they have it. There
often are no symptoms. Others feel tired or have mild flu-like
symptoms.
However, 20 percent to 25 percent of those who contract a
chronic infection develop serious complications. They can
develop liver cancer or cirrhosis or their livers ultimately
can stop working.
Pullara said there is no way to tell at the start of the disease
who might develop complications.
Inmates with hepatitis C now have their blood tested periodically
to see whether their liver function is deteriorating.
If a series of those tests reveals an inmate is likely to
suffer liver damage over time, that inmate is referred to
a treatment review committee and their liver functions are
monitored more closely. The committee decides for which inmates
the medication would be appropriate.
Prisoners can decide against treatment. Pullara said side
effects are "horrendous" and include nausea, vomiting
and possibly severe depression.
"If I had 100 people sitting in this room who have hepatitis
C I could only probably convince 10 to take the treatment,"
he said. "This is a fairly brutal treatment."
Back to top
Pamela
Anderson Says Hepatitis C May Kill Her in a Decade
Pamela Anderson says hepatitis C, which she was diagnosed
with in 2001, will probably kill her in a decade.
"I think I've got a good 10 years left in me, which is
sad, too. Maybe 15, if I'm lucky," Anderson tells Us
Weekly magazine in a first-person story for the Nov. 3 issue.
"It's scary, but lately I've been feeling great. For
some reason, my liver keeps getting healthier."
Hepatitis C causes inflammation of the liver, which can lead
to cirrhosis, liver cancer and liver failure. About 3.9 million
Americans have the disease. Anti-viral drugs are a standard
treatment, and therapy is successful about half the time.
But Anderson isn’t taking interferon,
the injectable drug hepatitis patients often use. Her homeopathic
doctor, Wendy Hewland, tells the magazine she "made a
single remedy specifically for Pam" that Anderson is
using as an alternative form of medicine.
The 36-year-old actress, who starred in
the TV shows "Baywatch" and "V.I.P.,"
also says she's no longer planning to marry singer Kid Rock,
to whom she got engaged in April 2002.
"We're not engaged anymore. Our relationship
is not really something you put a label on," she says.
"He wanted to buy me a house in Malibu, Calif., (in August),
but the thing is, I really just need to be with my kids and
work on their relationship with their father."
That would be former Motley Crue drummer Tommy Lee, with whom
she resolved an ugly custody battle in January. The couple
married in 1995 and divorced three tumultuous years later.
"There's definitely a lot of love and history between
Tommy and me, that's for sure. It doesn't matter whether we're
together or not. We're crazy about each other always have
been, always will be,'' Anderson says.
"I'm just happy that my kids (Dylan and Brandon) are
having a healthier, better relationship with their dad. Now
we spend a lot of time together as a family we go to movies,
we cook dinner, everything."
Back to top
Fast-Track
Review Speeds Japan Pegasys Approval
A fast-track review helped Chugai/Roche's Pegasys (recombinant
peg-interferon alfa-2a) gain Japanese approval for chronic
hepatitis C less than a year after filing. The submission
was made in mid-November 2002, resulting in a final clearance
last week. It is the first pegylated interferon approved in
Japan, where around 1.5 million people have chronic hepatitis
C, of whom 30-40,000 are receiving conventional interferon
therapy.
Pegasys's single once-weekly injection regimen (a fixed 180ug
subcutaneously) will considerably simplify treatment, which
should lead to rapid adoption, the firms predict. Local trials
(24 weeks of monotherapy) gave an overall sustained virological
response of 36%, higher than standard interferon, Chugai noted.
90 micro g and 180 micro g injection formulations have been
approved and should be price-listed and launched late this
year, into an interferon market which has grown by 13% on
average over the last four years.
Laboratory
Corporation of America. (LH) To Offer Liver Fibrosis Assay
HCV FibroSure™
PRNewswire
Through Exclusive Relationship With BioPredictive Laboratory
Corporation of America Holdings (LabCorp®) and BioPredictive,
a French diagnostics firm, today announced an exclusive partnership
that combines LabCorp’s expertise in infectious disease
testing with BioPredictive’s noninvasive, predictive
testing technology to quantitatively determine the amount
of liver fibrosis, and the rate of its progression, in hepatitis
C (HCV) patients. HCV FibroSURE™ is expected to be broadly
available in the U.S., only through LabCorp, beginning in
the first quarter of 2004.
This partnership gives U.S. physicians greater options when
assessing their HCV patients for liver fibrosis. As leaders
in their fields, both BioPredictive and LabCorp bring a rare
scientific expertise to the relationship that will benefit
U.S. physicians in search of the most up-to-date and effective
treatment options for HCV.
HCV FibroSURE™ is a noninvasive blood test, which uses
a combination of six serum biochemical markers in a patented
algorithm to predict fibrosis and necroinflammatory activity
in the liver. The extent of fibrosis and necroinflammatory
activity in the liver is a key component of assessing the
need for therapy in HCV infected patients and of predicting
the likelihood of progression to cirrhosis.
The current standard of care for assessing liver fibrosis
and necroinflammatory activity in HCV patients has been a
liver biopsy. However, a liver biopsy is an invasive medical
procedure that carries with it a risk of serious adverse events
due to bleeding and/or other complications.
Using the patented algorithm analysis of results from six
serum biochemical markers, HCV FibroSURE™ has been shown
in several studies to lead to a quantitative and reproducible
assessment of fibrogenic and necrotic activity in the liver
of HCV patients. The blood sample can be readily collected
in minutes and results can be returned to the physician within
days. The innovative, highly sensitive HCV FibroSURE™
assay provides an easily accessible alternative to a liver
biopsy in HCV infected patients.
“The type of scientific and corporate partnership we
have with BioPredictive is a key component of LabCorp’s
strategy to bring the latest in diagnostic technology to the
medical community,” said Myla P. Lai-Goldman, M.D.,
LabCorp executive vice president, chief scientific officer
and medical director. “As the only U.S. clinical laboratory
offering BioPredictive’s groundbreaking technology,
physicians now have additional assessment options for their
HCV patients. We are pleased to add this test to our broad
menu of clinical assays for this disease.”
“When biotechnology companies need a clinical laboratory
partner, they look for a company with a proven business strategy,
as well as scientific and technological expertise,”
said Dr. Thierry Poynard, a world-renowned hepatologist, head
of Hepato-Gastrotroenterology department in Pitie- Salpetriere
Hospital in Paris, researcher and founder of BioPredictive.
“We are excited to be working with LabCorp because they
are leaders in the world of hepatitis testing, and have a
keen understanding of the importance of new technology to
improve the management of HCV patients.”
About BioPredictive
BioPredictive is a young French start-up
of Paris-University, created in 2002, whose main purpose is
studying, designing, and developing biological tests. The
concept is to improve the management of disease by replacing
invasive strategies with noninvasive strategies. The first
step has been the discovery and development of biochemical
markers of chronic liver disease. Fibrotest is a biochemical
marker of liver fibrosis and Actitest is a marker of inflammation
and necrosis of the liver. BioPredictive is the company licensed
by Assistance Public-Hopitaux de Paris (AP-HP) to use and
sell the FibroTest and ActiTest noninvasive tests. These tests
will be available exclusively from LabCorp in the U.S. under
the name HCV FibroSURE™.
One year after FibroTest-ActiTest commercial launch, BioPredictive
performs over 2,000 tests per month and services 150 private
and 12 public hospital laboratories in France, Switzerland,
Portugal, Morocco and Mexico. Our partners are Paris Biotech,
AP-HP, CNRS, Universites Paris 5 and Paris 6. BioPredictive
was rewarded by the French research ministry at the Fourth
National Contest of innovative companies. To learn more about
BioPredictive, visit the web site at: http://www.biopredictive.com/
About LabCorp
Laboratory Corporation of America®
Holdings is a pioneer in commercializing new diagnostic technologies
and the first in its industry to embrace genomic testing.
With annual revenues of $2.5 billion in 2002, over 24,000
employees nationwide, and more than 200,000 clients, LabCorp
offers over 4,000 clinical assays ranging from blood analyses
to HIV and genomic testing. LabCorp combines its expertise
in innovative clinical testing technology with its Centers
of Excellence: The Center for Molecular Biology and Pathology,
in Research Triangle Park, NC; National Genetics Institute,
Inc. in Los Angeles, CA; ViroMed Laboratories, Inc. based
in Minneapolis, MN;
The Center for Esoteric Testing in Burlington, NC; and DIANON
Systems, Inc. based in Stratford, CT. LabCorp clients include
physicians, government agencies, managed care organizations,
hospitals, clinical labs, and pharmaceutical companies. To
learn more about our growing organization, visit our web site
at: http://www.labcorp.com/.
Each of the above forward-looking statements is subject to
change based on various important factors, including without
limitation, competitive actions in the marketplace and adverse
actions of governmental and other third-party payors. Actual
results could differ materially from those suggested by these
forward-looking statements. Further information on potential
factors that could affect LabCorp’s financial results
is included in the Company’s Form 10-K for the year
ended December 31, 2002 and subsequent SEC filings.
Laboratory Corporation of America Holdings
CONTACT: Pamela Sherry of Laboratory Corporation of AmericaHoldings,
+1-336-436-4855, or shareholder direct, +1-800-LAB-0401, orCompany
Information, http://www.labcorp.com/
Web site: http://www.biopredictive.com/
Web site: http://www.labcorp.com/
Back to top
October 22nd, 2003
Schering-Plough
Posts Quarterly Loss, Sales Fall
Bill Berkrot and Ransdell Pierson
Struggling drug maker Schering-Plough Corp. Wednesday reported
a third-quarter loss as sales fell and it increased reserves
for litigation related to investigations into its sales and
marketing practices.
Schering-Plough shares were off nearly 6 percent to near a
seven-year low as it battles a host of problems, especially
evaporation of Claritin sales. The former $3 billion a year
allergy drug went off patent last year and the company began
selling it over-the-counter at a fraction of its former price.
Chief Executive Fred Hassan, hired earlier this year to turn
the company around after bringing Pharmacia Corp. back to
financial health, promised no quick fixes.
“You really need to like both challenges and adventure
to work at Schering-Plough right now,” Hassan said on
a conference call with investors and analysts. “It is
a long process and for many of us it could be a painful process,
but you will see a new Schering-Plough emerge.”
The Kenilworth, New Jersey-based company said it lost $265
million, or 18 cents per share, compared with a profit of
$429 million, or 29 cents, a year ago.
Revenue fell 16 percent to $2.0 billion from $2.4 billion,
reflecting declining sales of its hepatitis C drugs and the
company’s former flagship medicine Claritin.
Excluding the 24 cents a share from the litigation charge,
Schering-Plough earned 6 cents a share—shy of the 10
cents a share Wall Street was expecting.
NO FORECASTS
Hassan declined to provide any future earnings projections,
citing uncertainty over when one of the company’s hepatitis
drugs may face cheaper generic competition and other factors.
“It’s not productive to give lot of numbers which
can be changed overnight,” Hassan said.
The company did provide one number that appeared to unsettle
investors—the addition of $350 million to litigation
reserves for ongoing investigations in Massachusetts and Pennsylvania.
The company said the reserves were an estimate and that actual
legal costs could be less. But it cautioned that costs could
also “materially exceed” the liability reserves
Schering-Plough has set aside.
“We still have a long, hard road ahead on legal front,”
Hassan said.
Meanwhile, sa
|
