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Alan Franciscus
Editor-in-Chief
- Early Virologic Response
(EVR) to Treatment with PEG-Intron (peginterferon alfa-2b)
Plus Rebetol (ribavirin) in Patients with Chronic Hepatitis
C
- Algorithm for HCV RNA Testing
to Identify Patients with Early Virologic Response Treated
with Peginterferon Alfa Plus Ribavirin
- Finding the Right Combination
to Fight Hepatitis C
- Vaccination Guide
- 12-Month Combination Therapy
with Intron A Plus Epivir-HBV Is Effective As Initial Treatment
of Patients with Chronic Hepatitis B
- Kidney Failure a Major
Problem in Transplants
- High body mass index is
a risk factor for nonresponse to treatment in hepatitis
C
- A Summary Review of Steps
in the Management of Chronic Hepatitis C
- Oral piercings can lead
to gum disease, infections and fractures
- Grant targets Southeast
Asian health education
- Operative morbidity of
living liver donors in Japan
- Fibromyalgia, Hepatitis
C Infection and the Cytokine Connection
- Interferon and Ribavirin
Safe for Patients with Hepatitis C-Related Renal Insufficiency
- Hassan Taps His Buddy
List
- S.E.C. Penalizes Schering-Plough
Over a Fair Disclosure Violation
- Hepatitis C virus infection
among drug users in Italy
- Nigeria bans dangerous
relaxant drugs from China
- Life-insurance ban is
unfair for many with HIV: Study
- Prison outreach for the
diagnosis and prevention of hepatitis C
- Warning of disease risk
on body art
- Is It Too Late To Save
Schering? ; CEO Fred Hassan has a hair-raising task: fixing
the drugmaker's problems in the lab, in the plants, and
in the market.
- Hepatitis C Virus; Early
Response to Therapy Allows Accurate Prediction Of Treatment
Success
- New process prolongs
blood platelets' shelf life
- North America's first
supervised heroin injection site opens
- Vancouver Opens Safe-Injection
Site for Addicts
- Variceal hemorrhage in
patients with cirrhosis
- Effective Methadone Dose
Does Not Harm Newborns
- Dude! You Call This Medicine?
- Description of Entecavir
Resistance-associated Mutations
- Hepatic injury in patients
taking the herbal weight loss aids
- Hep C blood 'went untreated'
- Isis Optimistic About
Latest Antisense Compounds
- Resection of hepatocellular
carcinoma in patients eligible for transplantation
- VA Seeks Former POWs
for Possible Benefits
- Cheaper Doesn't Mean Better.
Ask a Canadian
- Matria Healthcare Signs
Strategic Disease Management Agreement with Schering Corporation
- Predictive factors for
early mortality following liver transplantation
- Hepatitis Threatens to
Wipe Out Two Amazon Tribes
- UNICEF hopes to save
two ethnic groups in Peru after hepatitis outbreak
- Insurers issue new rules
on gays
- Molluscs could help fight
cancer
- Hepatitis A Boosters
May Be Unnecessary
- 'Whitey' from 'Leave
It to Beaver' Dies
- Sex with Strangers Dogging
English Parks
- Obesity Predicts Poor
Response to Hepatitis C Treatment
- Ribavirin ANDAs Still
Waiting For FDA; Other Generic Issues Have Priority
- Hepatitis virus could
be passed on by kissing
- State grant provides
Broward fire-rescue workers with free hepatitis C tests
- Hepatitis C seen as 'the
new epidemic'. Virus is four times more common than HIV,
experts say
- Nucleonics Receives NIH
Grant Supporting Research Partnership Aimed at Developing
RNAi Approach to Treatment of Hepatitis B Infections
- Herbal Web sites not
always honest
- Obesity as a risk factor
for cirrhosis-related death or hospitalization
- Transmission of Hepatitis
B and C Viruses in Outpatient Settings—New York, Oklahoma,
and Nebraska, 2000--2002
- Neb. Dr. in Hepatitis
Case Loses License
- Probe Ends in Schering-Plough
Drug Case
September 1st, 2003
Early Virologic
Response (EVR) to Treatment with PEG-Intron (peginterferon
alfa-2b) Plus Rebetol (ribavirin) in Patients with Chronic
Hepatitis C
by hivandhepatitis.com
Hepatitis C virus (HCV) replicates at a
rapid rate, producing between 1010 and 1012 viral particles
per day that have a half-life of only a few hours. Thus, virus
levels decline rapidly when a potent antiviral agent such
as interferon inhibits replication.
Viral kinetic studies have shown that the first phase of viral
decay occurs within 24 to 48 hours after a dose, is rapid,
and results in HCV RNA level reductions of up to 4 logs. However,
this early initial decline in HCV RNA levels correlates poorly
with the eventual response to interferon-based therapy.
Rather, treatment response correlates best with the subsequent
slow, prolonged, and more variable period of viral decline
referred to as phase 2 decay. The rate of phase 2 decay correlates
closely with sustained virologic response (SVR) to interferon-based
treatment regimens. Thus, it might be anticipated that changes
in virus level over the first several weeks of therapy might
correlate closely with the likelihood of ultimate eradication
of HCV.
The aim of this study was to investigate whether early changes
in HCV RNA levels during treatment with pegylated interferon
and ribavirin could be used to accurately predict treatment
response. Because early discontinuation of treatment in nonresponders
could avoid the expense and inconvenience of continuing unnecessary
treatment, the researchers also examined the potential cost
savings of strategies that would use early virologic response
(EVR) to develop early stopping rules for such patients.
Data from the recent international clinical trial reported
by Manns et al. comparing pegylated interferon alfa-2b (PEG-Intron;
Schering Corp., Kenilworth, NJ) plus oral ribavirin (Rebetol;
Schering Corp.) with standard interferon (Intron A; Schering
Corp.) and ribavirin was evaluated retrospectively to determine
whether EVR could predict treatment outcome.
The investigators most closely evaluated treatment responses
in the 511 subjects who were randomized to pegylated interferon
alfa-2b at a dose of 1.5 microgram/kg each week and 800 mg/d
of oral ribavirin (PEG/R) because this regimen was licensed
by the Food and Drug Administration.
However, they also examined the subgroup of patients (n =
174) from the above group who received pegylated interferon
alfa-2b at a dose of 1.5 microgram/kg each week and a dose
of ribavirin that was at least 10.6 mg/kg/d (PEG/R >10.6),
the so-called weight-based dosing regimen, because this is
the approved standard of care outside the United States and
may represent a more optimal dosing regimen.
Finally, the researchers also looked for comparison at the
505 subjects randomized to standard interferon at a dose of
3 million units 3 times per week plus 1,000 to 1,200 mg/d
of ribavirin (1,000 mg/d for a pretreatment weight <75
kg and 1,200 mg for weight >75 kg) (I/R).
All subjects were treated for 48 weeks and provided informed
consent for the study, and the ethics committee at each clinical
site approved the study. The databases for the study were
created and maintained by the study sponsor.
The researchers examined the accuracy of different degrees
of viral inhibition during the early weeks of treatment (early
virologic response [EVR]) with pegylated interferon alfa-2b
and ribavirin (PEG/R) in identifying patients who would not
respond to therapy.
The best definition of EVR was a reduction in hepatitis C
virus (HCV) RNA by at least 2 logs after the first 12 weeks
of treatment compared with baseline. Between 69% and 76% of
patients achieved this threshold, depending on the treatment
regimen, and sustained virologic response (SVR) occurred in
67% to 80% of these patients. Patients who did not reach EVR
did not respond to further therapy.
If treatment had been stopped in patients without EVR, drug
costs would have been reduced by more than 20% [Emphasis
added-Ed].
In conclusion, the authors state, "Early confirmation
of viral reduction following initiation of antiviral therapy
for chronic hepatitis C is worthwhile. It provides a goal
to motivate adherence during the first months of therapy and
a milepost at which to reassess the need for continued treatment.
Most patients who are able to complete the first 12 weeks
of therapy achieve EVR and have a high probability of SVR."
"Patients who fail to achieve EVR will not clear virus
even if additional months of therapy is received. Therapy
can be confidently discontinued in those cases."
Back to top
Algorithm for HCV
RNA Testing to Identify Patients with Early Virologic Response
Treated with Peginterferon Alfa Plus Ribavirin
by hivandhepatitis.com
Following is a new algorithm for HCV RNA testing designed
to identify peginterferon plus ribavirin-treated patients
with an early viral response (EVR) to therapy. These patients
have a high probability of achieving a sustained viral response
(SVR). The algorithm also will identify those treated patients
without EVR in whom treatment justifiably may be discontinued.
Quantitative HCV RNA testing is recommended at baseline and
at week 12 of therapy in patients with genotype 1. EVR (decrease
in HCV RNA > 2 logs compared with baseline or undetectable
by PCR at week 12 of therapy) is associated with a high chance
of response and justifies continuation of treatment.
Those who have at least a 2-log decrease in HCV RNA but remain
HCV RNA positive by PCR should have HCV RNA retested by PCR
at 24 weeks.
Because no patient without at least a 2-log decrease in HCV
RNA at 12 weeks subsequently achieved SVR, the lack of EVR
usually justifies discontinuation of therapy.
Patients with genotypes 2 or 3 have a high chance of achieving
EVR and SVR. Retesting of HCV RNA during treatment is not
cost-effective in these cases.
Back to top
Finding the Right
Combination to Fight Hepatitis C
by Linda Marsa
Just half of the millions of Americans
infected with hepatitis C respond to treatment, while others
who are infected live with the constant threat that their
health could suddenly, and fatally, deteriorate. But a new
drug could help improve these odds.
When used with the antiviral drug interferon,
the drug Zadaxin could help thousands of patients better fight
HCV. "This medication looks promising for people who
don't respond to other drugs," said Dr. Sammy Saab, liver
specialist at UCLA's David Geffen School of Medicine. "It
may also be used as part of a combination drug cocktail for
all hepatitis C sufferers, since it seems to work by a different
mechanism of action than other medications," added Saab.
Current HCV treatment - a combination of interferon and Ribarvirin
- helps only half of those with active infections and less
than a third who are infected with the more prevalent and
more dangerous form of hepatitis C known as genotype 1.
Zadaxin is a synthetic version of thymosin alpha 1, a naturally
occurring protein that stimulates the production of certain
immune system cells. The drug, which has no apparent side
effects, is approved for sale in 30 countries as an antiviral
drug to treat hepatitis B but only in a few countries to fight
hepatitis C.
However, results of a US study using Zadaxin to treat HCV
were encouraging. The test involved 31 patients with high
levels of genotype 1 who had not responded to standard therapy.
Zadaxin, used in combination with interferon, greatly reduced
levels of HCV in up to 36 percent of the patients.
The findings were particularly significant because patients
who do not respond to the initial round of treatment rarely
benefit from subsequent therapy. "We purposely chose
the most difficult of the most-difficult-to-treat patients,"
said researcher Di Bisceglie. Zadaxin is in the final phase
of US trials.
Around 4 million Americans are infected
with HCV, and about 2.7 million of those have an active infection
in which the liver is inflamed. Hepatitis C, which kills 10,000
people a year, is the leading cause for liver transplants
in the United States.
Back to top
September 2nd, 2003
Vaccination Guide
If you're wondering which diseases you should be immunized
against, the University of Southern California offers these
recommendations:
* Tetanus: Everyone should get a booster shot every 10 years.
* Rubella (German Measles): For health care workers and women
of childbearing age.
* Hepatitis A: For people at high risk, including intravenous
drug users, homosexuals, institutionalized people and people
traveling to or living in areas where it is endemic.
* Hepatitis B and C: High-risk adults such as dialysis patients
and health care workers should get the hepatitis B vaccination
and should get tested for hepatitis C, because symptoms often
don't show up for years. There isn't a vaccination for hepatitis
C.
* Pneumonia: For people over 65, plus diabetics and people
who have had their spleens removed or suffer chronic heart,
lung or liver disease.
* Influenza: Annual flu shots are recommended for the same
group of people who should get pneumonia shots.
* Travelers: If you're planning to visit another country,
you should contact its nearest consulate to ask whether specific
vaccinations are recommended or required.
Back to top
September 3rd, 2003
12-Month Combination
Therapy with Intron A Plus Epivir-HBV Is Effective As Initial
Treatment of Patients with Chronic Hepatitis B
by hivandhepatitis.com
Researchers in Turkey studied the
use of prolonged synchronous combination therapy with Intron
A (interferon (IFN)-alfa 2b) and Epivir-HBV (lamivudine) with
the use of IFN alfa-2b monotherapy in patients with untreated
hepatitis B e antigen (HBeAg) positive chronic hepatitis B
virus (HBV) infection.
Thirty-three patients received therapy
with lamivudine (100 mg daily) and IFN alfa-2b (10 million
U 3 times per week) for 12 months; 16 patients received IFN
alfa-2b alone (10 million U 3 times per week for 12 months).
The primary end point was sustained suppression
of HBV DNA and HBeAg seroconversion, which was observed in
15 (45%) of 33 patients treated with combination therapy and
in 3 (19%) of 16 patients treated with monotherapy (P = .133).
Both therapeutic regimens were well tolerated.
Combination therapy increased the rate
of sustained suppression of HBeAg and resulted in significant
improvement in Knodell histologic activity index scores, compared
with monotherapy. However, there was no significant difference
in rates of sustained suppression between the 2 groups at
the end of follow-up.
Discussion
Until now, the short-term use of IFN-alfa alone or in combination
with lamivudine has not been reported to be effective for
treatment of chronic hepatitis B infection. Data on combination
therapy are few and are restricted to studies of courses of
treatment of 4 6 months' duration. Moreover, the 4 published
trials of combination therapy provide little support for the
use of the IFN alfa lamivudine combination.
Also, the design of the initial studies of combination therapy
may not have been optimal for showing the full effects of
combination therapy. On the other hand, in many controlled
trials, it has been shown that there was an increased clearance
of both HBeAg and HBV DNA after prolonged IFN alfa therapy,
compared with treatment for the standard period of 16 weeks.
The current study demonstrates that administration
of combination therapy for 12 months to HBeAg-positive patients
induces rapid inhibition of viral replication, normalization
of liver function, and histologic evidence of improvement
in liver disease.
The study found a high rate of HBeAg seroconversion (54% of
patients) after 12 months of combination therapy, a finding
that is not in accordance with the seroconversion rate of
29% after 16 weeks of combination therapy reported by Schalm
et al., nor with the seroconversion rate of 33% after 24 weeks
of therapy reported by Barbaro et al.
The enhanced efficacy of prolonged treatment was so pronounced
that, in future treatment regimens that include combination
therapy, prolongation of therapy for up to 52 weeks should
be considered.
Unfortunately, despite the impressive HBeAg
seroconversion rates achieved at month 24, the difference
in sustained response rates between the 2 groups remained
non-significant at that time. Viral persistence was observed
after anti-HBeAg seroconversion in 3 patients in the combination
therapy group, and this influenced the level of significance.
Histologic evidence of improvement in liver
disease is a significant marker of biologic improvement after
therapy, especially when the number of patients is low. In
the present study, combination therapy significantly reversed
necroinflammatory activity, compared with IFN alfa mono-therapy.
This large benefit occurred regardless of patients' HBeAg
sero- conversion status and treatment response status in the
combination therapy group.
The 84% rate of improvement in hepatic inflammation observed
in these study patients was higher than the rate of 46% reported
by Barbaro et al., the rate of 56% after 1 year of lamivudine
therapy reported by Lai et al., and the rate of 54% after
a 24-month course of IFN alfa therapy reported by Lampertico
et al. Adding a prolonged course of IFN alfa therapy to a
course of lamivudine therapy seems to double the substantial
beneficial effect of lamivudine on liver disease.
In the present study, both treatment regimens
were safe and well tolerated, and the efficacy of concomitant
IFN alfa and lamivudine therapy appears to be better than
that of IFN alfa monotherapy and the previously studied sequential
administration of IFN and lamivudine.
Several factors may possibly explain this difference:
(1) A synchronous combination regimen is superior to a sequential
combination regimen;
(2) A prolonged course of combination therapy is more effective
than shorter course of combination therapy;
(3) Combination therapy is better than monotherapy; and
(4) Patients enrolled in this study tended to have a higher
mean ALT levels, a higher HAI score, and a lower stage of
fibrosis.
The authors conclude, "We conclude
that IFN alfa and lamivudine combination therapy, in combination
with a longer duration of therapy, appears to be a therapeutic
regimen and might be considered for the initial treatment
of patients with chronic hepatitis B."
Back to top
Kidney Failure
a Major Problem in Transplants
by Ed Edelson
HealthDay Reporter
Kidney failure is a disturbingly high risk for all transplant
patients, says the largest survey ever done.
Ironically, the major cause of those kidney
failures is an unavoidable side effect of the rejection-suppressing
drugs that made transplantation possible, experts say.
"The five-year risk of chronic renal
[kidney] failure after transplantation of a non-renal organ
ranges from 7 to 21 percent, depending on the type of organ
transplanted," says a report in the Sept. 4 issue of
the New England Journal of Medicine by transplant
specialists at the University of Michigan.
Kidney failure in those patients more than
quadruples the risk of death, the researchers say.
"The magnitude of the problem is much
higher than what one would expect based on what we see day-to-day
in the clinic," says study leader Dr. Akinlolu O. Ojo,
an associate professor of medicine at Michigan. "A number
of 20 percent is higher than one would come up with if one
had to make a guess."
The numbers come from a study of nearly
70,000 persons who received other-than-kidney transplants
(liver, heart, lung, heart-lung or intestine) in the United
States in the 1990s. Overall, 11,426 of those patients suffered
kidney failure in the first three years after surgery, an
incidence of 16.5 percent.
"While this report does not specifically
say so, previous work would suggest that the main cause of
kidney disease that arises after transplantation are these
drugs," says Dr. Colin C. Magee, a staff physician in
the renal division of Brigham and Women's Hospital, the teaching
hospital of Harvard Medical School.
Two drugs are the mainstays of efforts
to prevent the immune attack that kills transplanted tissues
-- cyclosporine, whose appearance in the early 1980s revolutionized
transplantation, and tacrolimus, which was introduced later.
"It is important to remember that
these are drugs are lifesaving drugs," Magee says. "Without
these drugs, transplantation would not be possible."
But the high incidence of kidney failure
after transplantation not only worsens the quality of life
but also can translate into a requirement for artificial kidney
treatment or kidney transplants for many thousands of patients,
which can strain medical resources, Magee says. While fewer
than 1 percent of Medicare patients have kidney failure, they
account for almost 6 percent of the Medicare budget, the editorial
says.
There are ways to lessen the problem, Ojo
and Magee say. It might be possible to use lower doses of
cyclosporine and tacrolimus in selected patients, and to use
newer rejection-preventing drugs in those patients, Magee
says. But doctors will be cautious about changing the existing
regimens, because any new dosage schedules might not be as
effective, he says.
Ojo proposes a strategy based on other
findings of the survey — that a number of factors other
than drug therapy contribute to the risk of kidney failure.
Those factors include older age, being a woman, having hepatitis
C infection, high blood pressure and diabetes, the survey
shows. Those factors can be combined in a formula to determine
a patient's overall risk, he says.
"We need a way to stratify people
before they get transplants so that we could reduce the amount
of drugs we use or use the newer drugs in these patients to
avoid toxicity," Ojo says. But he advises caution in
use of the newer drugs, because they may not be as effective
in preventing rejection as the two older medications.
Transplant centers, including the one at
Michigan, are not now using the risk-stratifying strategy
because the risk factors have not been laid out clearly, Ojo
says. The surgery results may help promote the strategy, he
says.
Back to top
September 4th, 2003
High body mass
index is a risk
factor for nonresponse to treatment in hepatitis C
by gastrohep.com
Physicians from Canada find that obesity is an independent
negative predictor of patients' response to hepatitis C treatment.
The aim of this study, published in the
latest issue of Hepatology (Hepatology 2003;
38: 639-44), was to determine whether body mass index (BMI)
predicts response to antiviral therapy for chronic hepatitis
C.
A team of doctors performed a retrospective
review of all patients with chronic hepatitis C treated with
antiviral medication at a single center, between 1989 and
2000.
They defined a sustained response as either
negative hepatitis C virus (HCV) RNA by PCR and/or a normal
alanine aminotransferase (ALT) level 6 months after the completion
of treatment.
The team divided patients into 3 groups
according to their BMI. These were <25 kg/m2 (normal),
25 to 30 kg/m2 (overweight), and >30 kg/m2 (obese).
A total of 253 patients were treated with
either interferon (IFN) monotherapy or IFN in combination
with ribavirin.
Patients were excluded if predetermined
clinical characteristics were unavailable.
Hepatic steatosis was not an independent risk factor for response
to antiviral treatment.
The team used logistic regression to analyze
the data.
After adjusting for several variables,
they found that there were significant differences in the
patients' response to treatment according to BMI group, virus
genotype, and cirrhosis.
Patients with genotypes 2 or 3 had an odds
ratio (OR) for success of 11.7 when compared with those with
genotype 1.
In addition, the team determined that cirrhotic
patients had an OR of 0.15 compared with noncirrhotic patients,
and obese patients had an OR of 0.23 compared with normal
and overweight patients.
However, the researchers did not find that
hepatic steatosis was an independent risk factor for response
to antiviral treatment.
Dr Brian Bressler's team concluded, "Obesity,
only when defined as a BMI greater than 30 kg/m2, is an independent
(of genotype and cirrhosis) negative predictor of response
to hepatitis C treatment.
Back to top
September 5th, 2003
A Summary Review
of Steps in the Management of Chronic Hepatitis C
by hivandhepatitis.com
Treatment options for chronic HCV infection have evolved
significantly over the last few years, and current therapy
with pegylated interferon and ribavirin is effective in 50%
to 60% of patients with previously untreated infection.
Although there is some encouraging progress
in new antiviral drug development for hepatitis C, it will
be several years before any of these novel compounds are available
in clinical practice.
In the interim, pegylated interferon and
ribavirin remain the cornerstone of therapy. Healthcare providers
have an important role in educating and selecting appropriate
patients for therapy, recognizing common side effects, establishing
a team approach to the management of chronic HCV infection,
and keeping abreast of changes in treatment guidelines.
Following are brief excerpts on approaches
to the treatment and management of chronic HCV from an article
by Drs. Keyur Patel and John G. McHutchison.
Before initiating therapy, ensure there
are no contraindications to interferon alfa (or peginterferon)
and ribavirin.
These include:
For Interferon Alfa or Peginterferon Alfa:
* Decompensated liver disease
* Autoimmune hepatitis
* Severe neuropsychiatric illness
* Unstable coronary artery disease
* Unstable epilepsy
* Poorly controlled diabetes
For Ribavirin:
* Anemia (hemoglobin, <11 g/dL)
* Hemoglobinopathies (thalassemia major, sickle cell disease)
* Ischemic heart disease
* Cerebrovascular disease
* Pregnancy
* Refusal to practice barrier contraception
* Chronic renal impairment (creatinine clearance, <50 mL/min)
There are 10 steps with which patient and
physician should move forward:
1. Ensure there are no contraindications to therapy.
2. Assess carefully for comorbid conditions (including depression,
hypothyroidism, cardiac disease, and diabetes) that should
be evaluated and controlled before starting antiviral therapy.
3. Determine HCV genotype and HCV RNA level.
4. Obtain liver biopsy to assess disease severity.
5. Discuss with the patient the side effects and possible
treatment outcomes.
6. If appropriate, start therapy with pegylated interferon
and ribavirin.
a) Determine dose of ribavirin according to genotype and weight.
b) Continue treatment for 24 or 48 weeks, according to genotype.
7. Perform laboratory monitoring.* (see Table 1).
8. Carefully perform a clinical evaluation monthly (or more
often) for depression and other side effects; assess treatment
adherence.
9. For genotype 1 infection, measure HCV RNA level at week
12.
a) Continue treatment for another 36 weeks if the patient
has an early
virologic response.
b) Consider terminating therapy if there is no early virologic
response.
10. Measure HCV RNA level at end of treatment. If HCV RNA
is still not present at 6 months post-therapy (a sustained
response), long-term eradication is likely to have occurred.
Table 1. A proposed laboratory monitoring schedule during
combination therapy monitoring schedule during combination
therapy for chronic hepatitis C
* Pregnancy tests should continue to be given every month
for 6 months post-therapy.
** Except in patients with genotype 2 or 3 infection.
Back to top
Oral piercings
can lead to gum disease, infections and fractures
by Frank D. Roylance
People who jab gold studs through their lips and pierce their
tongues with silver bars are not usually eager to hear a lecture
on gum disease.
But Dr. John K. Brooks tries anyway: Oral jewelry, the dentist
tells them, can cost you a tooth.
"The patients I've been successful with are the ones
that had pain and infection. They're much more ready to be
convinced," Brooks says.
Brooks and two colleagues at the University of Maryland Dental
School say there is growing clinical evidence that oral piercings
increase the risk of gum disease, painful infections and tooth
loss.
They present their case in the July issue
of the Journal of the American Dental Association. "The
profession does not advocate people wearing piercings,"
Brooks says, "and we want to discourage those people
who wear piercings."
With professors Kenny A. Hooper and Mark
A. Reynolds, Brooks' report on five patients who suffered
gum loss and other dental problems were traced to their lip
and tongue studs.
People who insist on wearing studs in their
mouths "have to maintain exquisite oral hygiene, brushing
and flossing," says Brooks. But even so, "there
is no escaping that they will be at risk for damage to their
gums and their teeth."
One of the subjects, a healthy 19-year-old
with a barbell-shaped stud in her tongue, developed a case
of worsening gum disease where the jewelry rubbed against
the inside of a lower front tooth.
Another patient, a 24-year-old woman, came
to the dental school's clinic complaining of painful teeth.
She has lost a significant amount of the gum in front of her
lower front teeth, next to her lip stud. The dentist also
found related bone loss. Warned of the damage, the woman agreed
to quit wearing the lip jewelry, the journal article says.
Chips and fractures
The JADA paper is the latest of several that have appeared
in medical literature since 1997, raising alarms about the
dental consequences of oral piercing. There have been no large-scale
studies so far, and the warnings are based on reports of a
few dozen individual cases.
The most common injuries are chips and
fractures—in as many as 80 percent of the patients in
one small survey cited by Brooks. Twenty percent of patients
in another small survey had suffered at least some gum loss
adjacent to their studs.
But that's not likely to come as news to many piercees.
"I chipped a tooth on it when I first got it," says
Julia Racicot, 24, who works in the bookstore at the Maryland
Institute College of Art and has worn a barbell in the center
of her tongue since she was 19.
But she removes the stud, cleans it regularly, and goes to
the dentist every six months. "I don't have any gum disease
or anything else," Racicot says
At MICA, where students say you're likely to stand out if
you don't have anything pierced, there are stories of students
who aren't so lucky.
Racicot said she heard of one young man who complained that
his labret (a lip stud) was "pulling down" his gum.
"His dentist told him, 'I'll fix it for you for free
if you'll take (the labret) out,' " Racicot says. The
man took the advice and began warning others about the danger.
Wear and tear on the gums
Reynolds, co-author of the JADA paper and a gum disease specialist,
says the association between oral jewelry and gum disease
seems clear: Gum loss occurs near studs, in places where young
people without the jewelry rarely experience it.
How does this happen?
Brooks says the relentless wear and tear on the gums leads
to chronic inflammation as the body tries to guard against
infection, remodel and repair the tissues. The gum tissue
breaks down and deeper down "you begin to have destruction
of the tissues that hold the gum to the roots," he says.
Bacteria that live naturally in the mouth rush in, and their
chemical byproducts create pockets behind the gums. More food
and bacteria accumulate, adding to the damage. The consequences
are pain, infection and tooth loss.
As if that weren't enough, the medical literature has reported
cases in which oral piercings have led to hepatitis, tetanus,
angina, heart-valve infections, brain and breast abscesses
and inflammation of the sac that surrounds the heart.
Piercing risks
* Infection. Infection
is a possibility with any opening in skin or oral tissues.
Given that the mouth is teeming with bacteria, oral piercing
carries a high potential for infection at the site of the
piercing. Handling the jewelry once it has been placed also
increases infection risk.
* Prolonged bleeding. Damage to the tongue's
blood vessels can cause serious blood loss.
* Swelling. Swelling is common after oral
piercing. Unlike an earlobe that is pierced, the tongue is
in constant motion, which can complicate the healing process.
There have been some reports of tongue swelling serious enough
to block the airway.
* Bloodborne disease transmission. Oral piercing
has been identified by the National Institutes of Health as
a possible factor in transmission of hepatitis B, C, D and
G.
* Endocarditis. Oral piercing carries a potential
risk of endocarditis, a serious inflammation of the heart
valves or tissues. The wound created during oral piercing
provides an opportunity for oral bacteria to enter the bloodstream,
where they can travel to the heart. This presents a risk for
people who have cardiac abnormalities, on which the bacteria
can colonize.
* Injury to gums. Metal jewelry can injure
gums, and if placed so it makes constant contact with the
gums, can cause them to recede.
* Damage to teeth. Contact with the jewelry
can chip or crack teeth. Teeth that have restorations can
be damaged if jewelry strikes them.
* Interference with oral function. Oral jewelry
can stimulate excessive saliva production, impede the ability
to pronounce words clearly, and cause problems with chewing
or swallowing. Metal alloys used to make oral jewelry may
cause allergic contact dermatitis.
* Interference with oral health evaluation.
Jewelry in the mouth can block the transmission of X-rays.
Clear X-rays are essential to a complete oral health evaluation.
Jewelry can prevent an X-ray from revealing abnormalities
such as cysts, abscesses or tumors.
*Aspiration. As with any loose object in
the mouth, jewelry that comes unfastened can be a choking
hazard.
Source: American Dental Association
Back to top
Grant targets
Southeast Asian health education
Barbara Anderson
Southeast Asian immigrants will learn how to prevent and manage
diabetes and hepatitis B under a program that trains lay members
of the community to teach the causes, signs and symptoms of
the diseases.
The Khmer Society of Fresno received a
three-year, $413,235 grant for the Southeast Asian Community
Health Cluster Project from The California Endowment.
The grant will enable the society to hire
three people who are fluent in Southeast Asian languages and
aware of the culture. Sequoia Community Health Foundation
will train the lay health workers on how to provide health
education in family homes.
The Khmer Society of Fresno cites a 2000
Fresno County Southeast Asian Health Promotion Survey that
found Cambodian and Laotian communities have high rates of
diabetes and hepatitis B, yet are unaware of the diseases'
causes and symptoms.
"Most of our folk don't know what is hepatitis B and
what is diabetes," said Tia Lam, executive director of
the Khmer Society of Fresno. "All of a sudden they get
it, and they're not aware of how they get it."
The health cluster project will be the
first time the community will have an opportunity to learn
about the diseases in its own language, she said.
The grant will focus primarily on Cambodian
and Laotian communities, but will be available to any Southeast
Asian in need of the services, Lam said. The goal is to serve
a minimum of 200 adults annually.
The three-year grant will "ensure
that Southeast Asian communities in Fresno have access to
the culturally competent services they need," according
to a statement from The Endowment's program officer, Carole
Chamberlain.
The Endowment, a private statewide
health foundation, will present a check to The Khmer Society
of Fresno on Friday at a traditional Buddhist blessing. The
society is a Cambodian, community-based nonprofit agency that
supports Cambodian and Laotian families in obtaining self-sufficiency
through employment, education and cultural preservation.
Back to top
Operative morbidity
of living liver donors in Japan
In contrast to western countries, no perioperative mortality
has been recorded in living liver donors in Japan, find researchers
in the latest issue of the Lancet (Lancet
2003; 362: 687-90).
Deaths of living liver donors have been
reported in western countries.
However, the morbidity and mortality of living liver donors
in Japan has not been studied.
In this study, a team of physicians reviewed
the operative morbidity and mortality of these donors.
They studied 1853 donors of 1852 living
liver transplants at 46 centers.
These donors were registered in the database of the Japanese
Liver Transplantation Society.
Overall, the team analyzed the data of
1841 donors for 8 donor-related factors of morbidity and mortality.
Complications were significantly higher
in right lobe donors.
No perioperative mortality was recorded between the inception
of the liver transplantation program in 1989 and 2002.
The researchers found that there were 244
postoperative complications were reported in 228 donors.
They determined that complications were
significantly higher in right lobe donors, compared to those
involving the lateral segment, and the left lobe.
Furthermore, postoperative hospital stay
was significantly longer in right lobe donors.
The doctors found that re-operation, related
to donor hepatectomy, occurred in 23 donors.
Dr Koji Umeshita's team concluded, "By
contrast with western countries, no perioperative mortality
was recorded in living liver donors in Japan".
"However, a proportion of these donors
developed serious complications".
"This morbidity should be reduced
to maintain zero mortality in living liver donors".
Back to top
Fibromyalgia,
Hepatitis C Infection and the Cytokine Connection
by hivandhepatitis.com
Fibromyalgia and chronic hepatitis C infection
share many clinical features including prominent somatic complaints
such as musculo-skeletal pain and fatigue. There is a growing
body of evidence supporting a link between cytokines and somatic
complaints.
This review by researchers in the Division
of Arthritis and Rheumatic Diseases, Oregon Health & Science
University, discusses alterations of cytokines in fibromyalgia,
including increased serum levels of interleukin (IL)-2, IL-2
receptor, IL-8, IL-1 receptor antagonist; increased IL-1 and
IL-6 produced by stimulated peripheral blood mononuclear cell
in patients with FM for longer than 2 years.
Other cytokine alterations discussed include:
* increased gp130, which is a neutrophil cytokine transducing
protein;
* increased soluble IL-6 receptor and soluble IL-1 receptor
antagonist only in patients with fibromyalgia who are depressed;
and
* IL-1 beta, IL-6, and TNF-a by reverse transcriptase-polymerase
chain reaction in skin biopsies of some patients with fibromyalgia.
In addition, this review describes the
mechanism by which alterations in cytokines in fibromyalgia
and chronic hepatitis C infection can produce hyperalgesia
and other neurally mediated symptoms through the presence
of cytokine receptors on glial cells and opiate receptors
on lymphocytes and the influence of cytokines on the hypothalamus-pituitary-adrenal
axis such as IL-1, IL-6, and TNF-a activating and IL-2 and
IFN-a down-regulating the HPA axis, respectively.
The association between chronic hepatitis
C infection and fibromyalgia is discussed, including a description
of key cytokine changes in chronic hepatitis C infection.
Future studies are encouraged to further characterize these
immunologic alterations with potential pathophysiologic and
therapeutic implications.
Back to top
September 8th, 2003
Interferon and
Ribavirin Safe for Patients with Hepatitis C-Related Renal
Insufficiency
By Emma Hitt, PhD
Interferon and ribavirin appear to be safe for use in patients
with hepatitis C virus (HCV)-related vasculitis and glomerulonephritis,
irrespective of renal function, a small study published in
Nephrol Dial Transplant 2003;18:1573-1580 suggests.
Hepatitis C virus (HCV) infection is associated
with kidney problems, including glomerulonephritis and focal
segmental glomerulosclerosis. HCV is generally treated with
interferon and ribavirin, but ribavirin is contraindicated
in patients with renal insufficiency due to concerns with
side effects.
Annette Bruchfeld, MD, with the Department
of Clinical Science at the Karolinska Institute, Sweden, and
colleagues treated 7 patients with a combination of interferon
(2 of whom received pegylatedinterferon) and ribavirin (average
daily dose of 200 to 800 mg).
Two of the patients had cryoglobulinaemia,
vasculitic manifestations, and glomeru-lonephritis; 4 had
membrano-proliferative glomerulonephritis; and 1 had focal
segmental glomerulosclerosis. All had renal insufficiency,
with a glomerular filtration rate (GFR) between 10 and 65
mL/min. One patient had HCV genotype 1, the rest had HCV genotype
2 and 3. Patients were treated for 6 to 12 months depending
on genotype.
Six of the patients became HCV-RNA-PCR
negative, and 4 out of 7 maintained both virological and renal
remission, while 1 patient maintained virological and partial
renal remission. One patient did not tolerate interferon but
achieved renal remission with low-dose ribavirin. One vasculitis
patient went into complete remission, but relapsed virologically
and had a minor vasculitic flare after 9 months.
"Only one patient with vasculitis
had low-dose immunosuppression in addition to anti-viral therapy,"
the researchers note. In addition, ribavirin-induced anaemia
was managed in 5 of the 7 patients with low-dose iron and
erythropoietin.
"In our experience it is reasonably
safe to use interferon and ribavirin in HCV-related vasculitis
and GN irrespective of renal function," Dr. Bruchfeld
and colleagues conclude. "However, the use of ribavirin
in renal insufficiency should be used with caution and ribavirin
plasma monitoring as well as surveillance of side effects
is recommended," they add.
They suggest that implementing interferon
and ribavirin treatment could improve treatment options for
HCV-related renal disease "and form a foundation for
controlled clinical studies in the field."
Back to top
Hassan Taps His
Buddy List
by Matthew Herper
Several weeks after Schering-Plough slashed its dividend by
68% and announced plans to trim 1,000 jobs through an early
retirement program, Chief Executive Fred Hassan says that
the Kenilworth, N.J.-based company continues to lose market
share for its top four drugs. But he still hopes to affect
a turnaround, just as he did at his last company, Peapack,
N.J.-based Pharmacia. To do that, he is calling in some help.
Hassan announced this morning that he has
tapped Michael J. DuBois to run global licensing at Schering.
Like Carrie Cox, who is global head of pharmaceuticals at
Schering, he held the exact same position at Pharmacia before
it was bought by Pfizer for $60 billion in April. DuBois will
report directly to Hassan.
His job will be an important one. Schering's
top sellers are hobbled. Hassan noted that sales of Claritin,
once the world's best-selling allergy pill, have "evaporated."
Patients have not switched to a very similar follow-up, Clarinex,
as quickly as Schering hoped. Its hepatitis C medicines, Rebetol
and Peg-Intron, are facing tough competition from a new entrant
from Roche, a Basel, Switzerland-based drug giant. Nasonex,
a steroidal nasal spray used to treat allergies, is also losing
market share, although Hassan hopes he can turn that around.
There are three ways for Schering to grow.
First, it can introduce new medicines. Hassan said he sees
a promising pipeline, but developing new drugs can take a
long time. Second, the company has lot riding on Zetia, a
cholesterol medicine that Schering is co-developing with Merck.
If the two companies can show that a combination of Zetia
and Merck's Zocor is safer or more effective than existing
cholesterol medicines, the combination could become a mega-blockbuster.
But it could take years to convince doubters that the combination
clears arteries or prevents heart attacks as well as existing
drugs.
In the meantime, there is the third path:
find new drugs being developed by other companies or academic
labs, and license the right to sell them for a cut of the
profits. But the competition for such deals is fierce. This
morning, French drug giant Aventis announced that it will
pay up to $510 million to Regeneron Pharmaceuticals for a
drug that is only in the first of three stages of clinical
trials. And Schering looks weak right now, which may not make
it exactly the partner of choice.
DuBois could face a tough task finding
new medicines to license. His boss could face an even tougher
task getting Schering on course.
Back to top
September 10th, 2003
S.E.C. Penalizes
Schering-Plough Over a Fair Disclosure Violation
by Floyd Norris
Using inside information, institutional investors were able
to save tens of millions of dollars by selling stock before
the public found out how badly profits were deteriorating
at Schering-Plough, the Securities and Exchange Commission
said yesterday.
The commission brought administrative proceedings
against the drug company and its former chief executive, Richard
J. Kogan. It issued cease-and-desist orders barring future
violations of Regulation FD, for fair disclosure. But it took
no action against the institutions that profited from the
inside information.
Schering-Plough agreed to pay a $1 million penalty, the largest
imposed for a violation of the fair disclosure regulation.
Mr. Kogan, who has retired from the company, agreed to pay
$50,000. He is the first individual to be penalized for violating
Regulation FD, which was adopted more than two years ago.
Neither admitted nor denied the accusations.
''Fair disclosure means creating a level playing field for
all investors,'' said Stephen M. Cutler, the commission's
director of enforcement. ''Bestowing an informational advantage
on a select few at the expense of others undermines investor
confidence and cannot be tolerated.''
Schering-Plough shares closed at $21.32 on Sept. 30, 2002,
before beginning a fall that cut 17.6 percent from the share
price over three days without the company making any public
announcement. That came as Mr. Kogan met with executives of
four institutional investors on the evening of Sept. 30 and
during the day Oct. 1, and then met with a larger group of
analysts on Oct. 3.
Late on Oct. 3, after the stock had fallen
to $17.64, the company put out a news release giving some
of the bad news, the S.E.C. said. The shares opened the next
day at $16.10, as public investors sent in sell orders.
The stock rallied above $23 in January, but the share price
has since declined. Yesterday, the shares rose 45 cents, to
$16.
According to the S.E.C., Mr. Kogan provided a litany of negative
information, in what he said and in his manner, in meetings
with the institutional investors.
''Providing guidance to a select few through a combination
of spoken language, tone, emphasis and demeanor, is precisely
the kind of unfair advantage that the S.E.C. wants to prevent,''
said Paul R. Berger, the associate director of enforcement
at the commission.
On the evening of Sept. 30, Mr. Kogan met
with executives from Wellington Management. That firm's drug
analyst maintained her buy rating after the meeting, but the
next day several of the firm's portfolio managers sold, the
S.E.C. said. The price of the stock ranged from $19.45 to
$21.80 that day.
On the morning of Oct. 1, Mr. Kogan met
with executives of Massachusetts Financial Services, a unit
of Sun Life Financial, and then with Fidelity Investments,
a unit of FMR, and Putnam Investments, a unit of Marsh &
McLennan. The M.F.S. analyst was already cautious on the stock,
and that firm owned few shares. But the Fidelity and Putnam
analysts, who had been supporters of the stock, turned negative,
issuing sell or underperform recommendations the next morning.
Fidelity and Putnam each sold more than
10 million shares from Oct. 1 through Oct. 3, the S.E.C. said,
accounting for more than 30 percent of the trading volume
in the period. Compared with the prices immediately after
the public disclosure, they saved at least $2 a share.
The shares fell further on Oct. 3, during the meeting with
other analysts. At that meeting, the S.E.C. said, Mr. Kogan
said earnings in 2003 would be ''terrible.''
One Putnam portfolio manager who attended
the meeting and sold shares said in a telephone conversation
with a Putnam trader, which was recorded, that the meeting
had made it clear Schering-Plough would not meet profit expectations.
''It's certainly why we are selling,''
he said, adding that he was at a health conference where other
investors were speculating about the weakness in Schering-Plough.
''So, the larger community, anyone who
didn't meet with them over the last couple days, doesn't have
a clue as to what's going on,'' the Putnam portfolio manager
said.
Nancy Fisher, a spokeswoman for Putnam,
declined to comment directly about the recorded statements,
but said the firm had started selling days before the meeting
and that the firm's analyst had indicated that he planned
to downgrade the stock.
Anne Crowley, a spokeswoman for Fidelity,
said, ''We complied with all rules and regulations in our
meeting with Schering-Plough and in our conduct thereafter.''
A call to Wellington Management was not returned.
Under federal law, it is often viewed as
insider trading when a trader receives a tip from a company
executive about material nonpublic information. But to bring
such charges the commission would have to prove that the money
managers knew the information was confidential and should
not be disclosed. S.E.C. officials would not comment, but
there is no indication that any action is contemplated against
the institutional investors.
A lawyer for Mr. Kogan, Stanley Sporkin,
said: ''There is no evidence that Kogan profited from this.
He did not buy or sell stock.''
Mr. Sporkin, a former federal judge and before that the director
of enforcement for the S.E.C., added: ''The real message is
that C.E.O.'s of companies have to be very careful when they
go one-on-one with analysts.''
Schering-Plough announced the S.E.C. settlement
but did not comment on it.
Chart: ''For Big Investors, Advance
Warning''
Schering-Plough and its former chief executive, Richard J.
Kogan, agreed yesterday to pay penalties for what the S.E.C.
said were violations of the commissions fair disclosure regulation
last fall. At that time the company gave bad news to selected
institutional investors before disclosing it to the public
.
SEPT. 30 -- Mr. Kogan briefs officials
of Wellington Management in the evening.
OCT. 1 -- Mr. Kogan meets with officials of Massachusetts
Financial Services, Fidelity Investments and Putnam Investments.
OCT. 2 -- Analysts at Fidelity and Putnam advise managers
to sell the stock before trading begins.
OCT. 3 -- Mr. Kogan meets with more analysts and says profits
in 2003 will be terrible. At 10:45 p.m., company discloses
part of what was told to analysts.
Back to top
Hepatitis C virus
infection among drug users in Italy
by gastrohep.com
Anti-HCV status is independently associated with drug use
duration and route of administration, find doctors in the
September issue of the Journal of Viral Hepatitis
(J Viral Hepatitis 2003; 10(5): 394-400).
This study, conducted by researchers from
Italy and the United States, assessed the rates and predictors
of hepatitis C virus (HCV) infection in drug users receiving
treatment for opiate addiction.
The team evaluated a cohort of 1095 participants
in 16 centers for drug users in north-eastern Italy.
They collected data using standardized
face-to-face interviews in 2001. 74% were HCV seropositive.
The team found that, of 1095 participants,
74% were HCV seropositive.
They determined that anti-HCV status was
independently associated with drug use duration >10 years,
injecting, as well as hepatitis B (HBV) and HIV seropositivity.
The physicians analyzed subjects further,
based on duration of heroin use (greater or less than 10 years).
They found that both the route of drug
administration and HBV status were associated with HCV seropositivity
in both groups. However, less education was associated with
HCV in the shorter term drug users.
Both HIV status and having a sexual partner
with a history of drug use were associated with HCV seropositivity
in longer term drug users.
Dr Quaglio's team concluded, "Half
of the short-term heroin users were still HCV seronegative
when starting treatment, suggesting opportunities for reducing
new HCV infections."
"Remarkable was the relationship between
vaccination for hepatitis B and HCV serostatus."
"Being HBV seropositive was strongly
associated with being HCV seropositive."
"But heroin users who had been vaccinated
for HBV were not significantly more likely to be HCV seropositive
than heroin users who were HBV
seronegative."
"HBV vaccination does not provide
biological protection against HCV; however, vaccinating heroin
users against HBV may help to create a stronger pro-health
attitude among heroin users, leading to a reduction in HCV
risk
behavior."
Back to top
September 12th, 2002
Nigeria bans dangerous
relaxant drugs from China
The Nigerian government has banned a family of relaxant drugs
imported from China, said to have possible serious side-effects
including hepatitis, cirrhosis and liver failure, an official
statement said.
The National Agency for Food and Drug Administration and Control
(NAFDAC), the state-run regulatory agency for all drugs in
the country, warned Nigerians of the harmful effects of products
containing kava-kava and kavaine, said the statement.
Such products, which are easily obtainable on the Nigerian
market, are used in the treatment of conditions such as nervous
anxiety, stress and restlessness, and to treat the symptoms
of menopause, the NAFDAC statement said.
But the drugs—banned by most drug regulatory authorities
worldwide and the World Health Organization—have been
implicated in serious liver diseases, including hepatitis,
cirrhosis and liver failure, it also said.
A top NAFDAC official told AFP Friday that the dangerous drugs
have been in circulation in Nigeria for the past three years.
Efforts have been stepped up to withdraw them from the market.
Drug importers and the Chinese embassy in Nigeria are cooperating
with NAFDAC to enforce the ban, said the official who declined
to be named.
Back to top
Life-insurance
ban is unfair for many with HIV: Study
A ban on life insurance for people with the AIDS virus is
in many cases unjustified, according to the first study to
provide hard actuarial evidence about the benefits of anti-retroviral
drugs.
Life insurance companies, scared by the
mortality rates seen in the early years of the AIDS epidemic,
routinely deny insurance to people with the human immunodeficiency
virus (HIV ) and this can cause big problems for those individuals,
in their business and personal lives.
But a Swiss study says the automatic ban fails to take into
account the success of antiretrovirals—the drug "cocktail"
that emerged in the mid-1990s and which, for many people with
HIV, has otherwise prolonged their survivability.
People who respond well to HIV and who do not have hepatitis
C have a short-term mortality rate that can be even lower
than people who have been successfully treated for cancer
and who are usually able to get life insurance, the study
says.
Amongst the HIV group, the excess death
rate—a figure that compares patients to people without
the disease—was below five per thousand patient-years.
Amongst the cancer group, the rate varied from five to 20
per thousand patient-years.
The study, published in this Saturday's issue of the British
medical weekly The Lancet, "provides preliminary
evidence that life coverage could be considered under specific
conditions," the authors say.
However, short-term mortality was significantly higher among
HIV patients who had failed to respond to antiretrovirals
or who had hepatitis C, a disease linked to intravenous drug
use.
The research was led by Bernard Hirschel of Geneva University
Hospital, and drew on figures from a six-year-old, ongoing
study of Swiss patients with HIV and from national mortality
statistics.
Antiretrovirals contain the spread of HIV virus so that the
body's immune system remains intact and does not reach the
stage of full-blown AIDS, when death can be caused by opportunistic
diseases.
These drugs are not a cure, however, and
can have toxic side effects.
Their cost, too, is a barrier to
treatment. Only recently has the price been lowered sufficiently
for developing countries to contemplate distributing the treatment
on a wide scale.
Back to top
Prison outreach
for the diagnosis and prevention of hepatitis C
by gastrohep.com
Prison outreach clinics are effective in delivering health
education, but have a limited effect in eradicating hepatitis
C virus in prisoners, finds a team of physicians in the October
issue of Gut (Gut 2003; 52: 1500-4).
Hepatitis C virus (HCV) infection is a major public health
problem
A prison environment provides the opportunity for healthcare
workers to focus on traditionally hard to reach patients.
In this study, researchers from Southampton,
England, assessed the prevalence of HCV infection in a prison
cluster. They also evaluated the effectiveness of a prison
outreach service for hepatitis C.
The team established a nurse specialist-led
clinic within the prisons. This offered health education on
hepatitis C, advice on harm minimization, and HCV testing.
Any prisoners infected with HCV were offered
access to treatment.
30% of the prisoners tested had active HCV infection.
The research team measure the level of
service uptake, and diagnosis and treatment of hepatitis C.
Overall, the team found that 9% of 1618
prisoners in this study accepted testing. They found that
30% of these prisoners had active HCV infection.
However, most prisoners were ineligible
for treatment due to psychiatric illness, or did not receive
treatment for logistic reasons.
The researchers determined that injecting
drug use was the major risk factor in all cases.
The team also found that only 7% of HCV
polymerase chain amplification positive inmates received treatment
while in prison.
Dr Skipper's team concluded, "There
is a large pool of HCV infected prisoners at risk of complications,
constituting a source of infection during their sentence and
after discharge."
"A prison outreach clinic and care
pathway was perceived as effective in delivering health education,
reducing the burden on prison and hospital services."
"It provided an opportunity for intervention
but had a limited effect in eradicating HCV in prisoners and
it remains unclear how this might be achieved."
Back to top
September 14th, 2003
Warning of disease
risk on body art
by Mark Gould
Once the preserve of fetish clubs and tribal groups, body
art has fought its way into mainstream culture as tattoos
and piercings have become the must-have adornment for the
young and famous.
David Beckham's body artwork has undermined
tattoos' reputation as symbols of rebellion, while Madonna's
pierced belly button and Zara Phillips's tongue stud have
given body-piercing a more respectable public image. The craze
has even reached the aisles of Selfridges, which opened a
tattoo and body-piercing concession earlier this year called
Metal Morphosis.
But doctors are now warning such fashion accessories could
be fatal. Tattoos and body-piercing could lead to a risk of
contracting the liver disease hepatitis B, which can be passed
on via infected needles.
The Royal College of General Practitioners is urging the fashion-conscious
to avoid piercing altogether and opt for stick-on tattoos
because hepatitis B rates have doubled in the past 10 years.
Dr George Kassianos, a GP and spokesman for the RCGP, said:
'The risk is too great that the (tattoo) parlour has cut corners
by re-using tattoo needles or not sterilising equipment. If
you want to decorate your body get a transfer - they are usually
better quality anyway."
In December last year Sheffield teenager
Daniel Hindle, 17, died when he contracted blood poisoning
after having his lip pierced. In June a tattoo and piercing
parlour in Dundee was closed down amid fears of a hepatitis
B infection when health officials found equipment and skin
cream contaminated with blood. Public health doctors have
found no evidence of hepatitis B but are screening more than
60 customers. The disease can be passed from mothers to newborn
babies, and by using infected needles, razors, or toothbrushes
and by having unprotected sex.
The risk of passing on the infection is
so great that blood donors are banned from donating for 12
months after they have been tattooed or pierced. The National
Blood Agency says that one in 10 donors are turned away on
any one day because of a new piercing or tattoo.
Last month local authority inspection and hygiene rules previously
restricted to body art parlours in London were extended across
England in a bid to crack down on infections and botched piercings.
But the doctors' warning prompted a sharp response from body
artists. Curly, a tattooist from the Tattoo Club of Great
Britain, in Oxford, thought the RCGP's advice was 'unbelievable.'
'What kind of moron says a thing like that?
As long as you take sensible hygiene precautions it's perfectly
safe. People have been doing it for thousands of years. Twenty
or 30 years ago we used the same needle all day without sterilising
it and nobody got hepatitis. Now I have got an autoclave where
I sterilise the needles and I keep a record of the temperatures
they are heated to. I just think people are taking this health
and safety thing a bit too far.'
Metal Morphosis 'director and celebrity
piercer' David Potasnick said he set up the International
School of Body Piercing to raise standards of skill and safety.
'I would like to see stricter regulations placed on piercing
to ensure better quality of service through out the industry
and I would urge anyone considering getting a piercing to
fully research the studio beforehand to ensure that they are
in the hands of a licensed professional,' Potasnick said.
There are around 180,000 people with hepatitis B in the UK.
But Public Health Laboratory Service figures show that in
the past decade the number of new cases has doubled from 400
to more than 800 a year with many new cases in refugees and
asylum-seekers.
Kassianos said official fig ures mask a
larger group who don't know they have the disease. 'It's estimated
there are around 800 new cases a year but there could be as
many as 3,500 people newly infected who don't know it and
are passing it on.'
The problem is becoming so acute that the
government's Joint Committee on Vaccination and Immunisation
is considering setting up a 2childhood hepatitis B immunisation
programme.
Kassianos wants immunisation introduced
as soon as possible. 'This is not a racist measure or anti-refugee
- the fact that we can all move about the world so easily
means that hepatitis B is a problem for the whole population
of the UK.'
Last year the prestigious Mayo Clinic
carried out the only scientific research on the extent of
body art in an unnamed American university. It found that
half of all the undergraduates had some form of body piercing.
One in five suffered injury or prolonged bleeding and one
in 10 had a bacterial infection.
Back to top
September 15th, 2003
Is It Too Late
To Save Schering? ; CEO Fred Hassan has a hair-raising task:
fixing the drugmaker's problems in the lab, in the plants,
and in the market.
John Simons
Fred Hassan talks like a professional therapist. Not in a
cooing, I-feel-your-pain, Oprah sort of way, but with a gentle
authority that, no matter how harsh the pronouncement, is
still soothing. Schering-Plough needs such treatment. Since
taking over as CEO of the troubled pharmaceutical company
four months ago, Hassan has had to fire senior managers, cut
salaries, and shut down research. At the same time, he is
campaigning to restore morale within the company and trust
outside it. It's a tricky prescription, but his verbal balm
is soothing.
On a Friday in July, Hassan is doing it again, this time in
a small meeting room on the grounds of Schering's sprawling
Kenilworth, N.J., headquarters. Eleven midlevel researchers
are seated around the table eating cold cuts and potato salad.
Hassan has called them together to hear their opinions on
what ails Schering. A computer technician speaks up, arguing
that new drug applications go through too many hoops before
going to the Food and Drug Administration. "I'm sensing
that because we made mistakes in the past, 'speed' is a bad
word around here," says Hassan in his mild Pakistani
accent. "Am I right?" Everyone nods. The technician,
as if waiting for years for someone to utter those words,
lets out a long "yessss."
His management style may seem soft and
fuzzy, but Hassan insists that it is the stuff of which great
CEOs are made. Doing well in business, he says, is about "getting
to the hearts of people—that's something you don't learn
in business school. Can you teach someone to engender trust?
That separates leaders from managers."
All that's nice. But no one will really
care unless it means Hassan can fix Schering. With annual
sales of $10.1 billion, it is the country's ninth-largest
drug firm. It specializes in allergy and respiratory drugs
and anti-infection, cancer, and cardiovascular treatments.
The company is best known for Claritin, the breakthrough allergy
medicine that didn't make users drowsy. Schering also produces
such respiratory drugs as Afrin and Nasonex; foot-care products
like Dr. Scholl's insoles; antifungal medicines Lotrimin and
Tinactin; Coppertone and Bain de Soleil sunscreen products;
and animal health treatments.
Until recently investors loved Schering-Plough, and it's easy
to see why. In 2000 the company posted its 15th consecutive
year of double-digit growth in earnings per share and raised
its dividend for the 17th time since 1986. During the 1990s
its shares soared 978%.
But Big Pharma is suffering through difficult
times. Since 2000 the S&P pharmaceuticals index has fallen
19%, while the S&P 500 is off 13%, and the drug industry
has not recovered as fast. While every drug company faces
serious challenges in one or two areas, Schering has problems
in all of them—sales, marketing, research, and manufacturing.
Take a look at sales. The most important thing to know is
that revenues are dwindling--fast. At its peak in 2001, Claritin
generated $3.2 billion, almost a third of Schering's total
revenues. Since Claritin lost its patent protection last year,
cheaper knockoffs have cut its sales by 97%, and management
bungled the introduction of its successor, Clarinex. Schering's
next- largest franchise, the Intron family of hepatitis C
medicines (sales in 2002: $2.7 billion), is also losing ground.
In the labs Schering is mediocre at turning R&D investment
into patents (see chart). The single bright spot is Zetia,
a cholesterol- lowering drug developed as a joint venture
with Merck. Zetia could generate $711 million for Schering
by 2006.
The manufacturing division is even more
troubled. Executives entered a consent agreement in May 2002
in response to the FDA's accusations of unsafe manufacturing
practices, such as the production of defective tablets and
asthma inhalers (see "Bitter Medicine," on fortune.com).
The FDA imposed its largest fine ever-- $500 million--and
forced Schering to bolster its oversight of production, which
is proving costly.
Schering is also the subject of a separate FDA criminal investigation
into whether company officials knowingly distributed faulty
products. In addition, the attorneys general of Massachusetts
and Pennsylvania are investigating allegations that the sales
division marketed certain drugs for unapproved or "off
label" uses. And the SEC is looking into a charge of
selective disclosure of financial information.
Put it all together, and it is no surprise
that Schering's net income for the first half of 2003 dropped
71%, to $355 million, from $1.2 billion the previous year.
The stock has lost almost 75% of its value since November
2000 (see chart) and could drop further after the recent announcement
of a sharp cut in the dividend. Hassan did not help matters
when he failed to participate in an Aug. 21 conference call
to explain the decision. Even friendly analysts were piqued
by his absence.
Ducking the analysts was uncharacteristic for Hassan. What
sets him apart from other CEOs in the industry is that he
is, first and foremost, a communicator. Sure, he's been known
to stand at a podium flipping slides while droning on about
"seamless product flow." And he isn't exactly Mr.
Flair. His suits range in color from slate to charcoal. His
ties run the gamut from red to maroon. His shirts are white.
It's a safe bet that his base annual salary of $1.5 million
(through 2006), plus stock and options worth $14 million,
will not be spent on frippery.
His formal demeanor, however, is not a forbidding one. Hassan
likes to talk tactics with salespeople and show off his scientific
background with the techies. In the numerous large town-hall
meetings and smaller roundtables he has held to engage workers,
people are not afraid to say tough things. One evening in
early August, for example, he's having dinner with salespeople
from the New York--New Jersey region. He has barely stuck
a fork into his roasted chicken when the complaints start:
The staff wants more products to sell and is tired of fending
off rants about the company's problems. The main question:
Is he planning to do away with the 60-40 salary-commission
split? Hassan gives it to them straight. "The problem,"
he says, is that the commission is "just too high."
The industry standard is 30%.
After each meeting, Hassan answers employees
via e-mail. As with the salespeople, he cannot always tell
employees what they want to hear. Still, the fact that he
is trying to communicate comes across loud and clear. After
one roundtable, a researcher comments, "I couldn't tell
you what the former CEO [Richard Jay Kogan] looked like. We
got an e-mail from him once a year. That was it."
One asset Hassan can count on is that Schering's
30,000 employees haven't given up. "When I leave here
sometimes around seven at night, I still see many cars in
the parking lot. That's a good sign," he says. "Now,
whether they're waiting for traffic on the New Jersey Turnpike
to clear up is another question."
Farid Hassan (his original name) left Pakistan at age 17 to
study chemical engineering at the University of London. He
stumbled into business when he returned to Pakistan in 1967
and began a painfully boring job at a fertilizer plant. In
the meantime he met his wife, Noreen, whom he credits with
helping him recognize his aptitude for management. By the
summer of 1970 the newly married Hassan was off to Harvard
Business School. After graduation he took a job with Sandoz
Pharmaceutical Corp. (now Novartis). It was there that he
began pulling off a string of turnarounds. In 1975, Sandoz
executives sent Hassan to Lincoln to reorganize a marketing
unit in disarray. He did. Five years later he went back to
Pakistan to run the company's then-miserable operations. Within
three years the unit went from the No. 15 drug seller to No.
4. By 1987, Hassan had become CEO of Sandoz. He left to take
the top job at Wyeth in 1989. In 1997, he became CEO of Pharmacia,
two years into a disastrous merger of Sweden's Pharmacia and
Upjohn Co. of Kalamazoo, Mich.
Cultural differences were at the heart
of the problem. In one case Pharmacia's European managers—who
ran their own marketing and research operations—ignored
a promising antibiotic known as Zyvox simply because it had
been developed in Kalamazoo. Rather than fight one cultural
battle after another, Hassan moved the company's headquarters
from England to northern New Jersey. That consolidated the
company in new territory. He also merged the various marketing
and research efforts.
On Hassan's watch Pharmacia's revenues
grew from $8.9 billion to $14 billion, while earnings per
share tripled. In 2000 he orchestrated a merger with Monsanto,
which brought in Celebrex, the company's top-selling arthritis
pain reliever (sales last year: $3 billion). Pfizer took notice,
paying $60 billion to acquire Pharmacia in 2002. Critics say
that a genuine turnaround would have enabled Pharmacia to
stay independent. That is a debate for the business schools:
The fact is, Hassan put himself out of a job— and made
Pharmacia shareholders very happy.
If he can turn around Schering, Hassan could become one of
the most influential pharma executives in the country. True
to his orderly ways, he ticks off a plan: "One, stabilize;
two, repair; three, turn around; four, build the base; and
five, break out." For the past few months he has tackled
the first and second steps: investigating problems, looking
at the books, and figuring out where to cut costs. In late
August he announced plans to eliminate nearly $200 million
in annual spending. A thousand jobs will go, as well as the
company jet, merit salary increases, the executive dining
room, and bonuses (including his own). In an e-mail to employees
Hassan reinforced the new tenor of austerity. "We must
attack our cost structure with a renewed sense of urgency,"
he wrote. "Each person in our organization must think
like an owner." The most draconian measure was to cut
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