Preliminary study of combination therapy with
interferon-alpha and zinc in chronic hepatitis C patients with
genotype 1b. <br>Nagamine T, Takagi H, Takayama H, Kojima
A, Kakizaki S, Mori M, Nakajima K.
<br><br>Department of Health Science, Gunma University School of
Medicine, Maebashi, Japan. <br><br>We have evaluated the
efficacy of interferon-alpha (IFN-alpha) plus zinc therapy
in hepatitis C patients with genotype 1b, poor
responders for IFN alone. Ten patients were injected with 10
MU of IFN-alpha every day for 4 wk, followed by
three times a week for 20 wk (control group). Nine
patients took 300 mg of zinc sulfate a day orally during
IFN-alpha therapy (zinc sulfate group), and 15 patients
took IFN-alpha and 150 mg of polaprezinc (polaprezinc
group). On the d 8 of IFN therapy, circadian zinc levels
in serum elevated significantly in the polaprezinc
group compared to the zinc sulfate group or control
group. Serum ALT levels normalized in 73.3% of the
polaprezinc group, 55.6% of the zinc sulfate group, and 40.0%
of the control group at 6 mo after the end of IFN
therapy. Sustained eradication for the hepatitis C virus
RNA judged at the end of the 6-mo follow-up period
was higher in the polaprezinc group than in the zinc
sulfate group (53.3% vs 11.1%, p < 0.05) or the
control group (20.0%). No clinical side effects of zinc
were observed at the dose used. The data suggest that
polaprezinc is expected to increase the therapeutic response
of IFN-alpha for chronic hepatitis C with genotype
1b. <br><br>Publication Types: <br>Clinical trial
<br><br>PMID: 11051596 [PubMed - indexed for MEDLINE]
HMOs Required to Explain Denial of Care <br>By
Jordan Rau <br>ALBANY BUREAU CHIEF <br><br>October 17,
2001 <br><br>Albany - Attorney General Eliot Spitzer
yesterday announced a legal <br>agreement requiring seven
of the state's largest HMOs to provide <br>patients
with much more detailed explanations when their
requests for medical care are denied. <br><br>Spitzer said
the agreement was the result of a two-year
investigation <br>that found many HMO claim denials were so
vague or perfunctory that patients could not fashion an
effective appeal. <br><br>"It was very clear we were not
getting adequate information," Spitzer <br>said. <br>The
companies that signed the agreement are: Aetna/U.S. Health
Care, <br>Prudential Health Plan, Group Health
Incorporated, HIP Health Plans, <br>Vytra Health Plans, Oxford
Health Plans and Excellus Health Plans.
<br><br>Together, they serve about 7.5 million New Yorkers. The
companies also <br>agreed to pay $1 million total to cover
the costs of Spitzer's <br>investigation.
<br><br>While Spitzer called the agreement a landmark, the New
York Health Plan Association, an industry group,
downplayed its significance, saying that the attorney
general's investigation raised "technical issues only"
rather than unearthing evidence that patients were
inappropriately denied medical care. <br><br>"In essence, this
reaffirms existing practice, as plans are currently
<br>providing this information to members, as required by New
York's <br>External Appeal Law," Paul Macielak, the
president and chief executive of the association, said in a
statement. "The Attorney General's review of plan documents
involved cases that were at least two years old, predating
this successful law." <br><br>Since 1997, patients
have been allowed to appeal whenever their
<br>insurance company rules that a treatment is experimental or
not medically necessary. <br><br>The first stage of
the appeal is within the company, but under state
<br>law, patients who lose their appeals can then bring
their cases to health care practitioners with no
connection to the insurance company. <br><br>Spitzer said,
however, that appeals have been hampered by excessively
<br>curt HMO explanations. In one case cited by Spitzer's
office, a patient was denied further inpatient care at an
acute rehabilitation facility. The only reason provided
was that the patient could move 200 feet and up and
down 24 steps, both with supervision. <br><br>"The
cognitive functioning training will be long term, and can
be <br>continued as outpatient," the HMO ruled,
according to Spitzer's office. <br><br>Richard Kirsch,
director of Citizen Action of New York, a consumer
<br>group, said: "Many consumers, confused and frustrated by
HMO denial notices in the past, will now be empowered
to appeal. These agreements provide consumers and
their health care provider with a powerful tool."
Although volunteering has long been touted for
its social responsibility and psychological benefits,
it appears to also have some health benefits.
Helping others simply feels good, providing a sense of
purpose and well-being. That in itself can be energizing
and spiritually fulfilling, helping to reduce stress
and possibly boosting the immune system, say some
researchers. <br>But two new studies show that these benefits
may be strongest among retirees, and one speculates
that volunteering may even help seniors live longer.
<br><br>At the Institute for Social Research at the
University of Michigan, researchers found that retirees who
volunteered about 40 hours per year had a 30 percent reduced
risk of dying during a seven-year follow-up period
compared with other retirees who didn't volunteer. In
addition, retirees who volunteered for one organization --
regardless of the number of hours -- the reduced risk was
about 40 percent. <br><br>That study, involving 1,211
people who were 65 and older and published in a recent
issue of the Journal of Gerontology: Social Sciences,
showed that the most benefit came from modest
participation in volunteering. "Because of age, these people
may be experiencing health declines and physical
limitations," says Marc Musick, Ph.D., principal author of the
study and now an assistant professor of sociology at
the University of Texas at Austin. "If you take on
too much volunteering, there may be certain stresses
incurred that could offset those positive effects."
<br><br>Meanwhile, another study by Cornell University researchers
found that retirees who volunteered or participated in
community organizations reported feeling happier, more
energetic and have a greater sense of "mastery" over their
lives than other retirees who aren't active in their
community. That study, which involved 762 retirees between
ages 50 and 72, was presented before the American
Sociological Association in Chicago this summer.
<br><br>Although previous studies have shown that volunteering
tends to make most people feel better -- at least about
themselves -- these two studies indicate that perhaps
retirees may reap the most advantages of staying active.
<br><br>"Later in life, volunteering takes on a very special
role," says Dr. Musick. "Whereas for younger adults,
working, taking care of children, those kinds of things
are very important to them in their lives and
volunteering may not be as important. Volunteering may be
helpful to them, but these other things are so pivotal in
people's lives that they may be overriding anything that
volunteering could do." <br><br>Volunteering activities that
involve working with others has the biggest positive
impact on these seniors, says Phyllis Moen, Ph.D., a
professor of human development and sociology involved in
the Cornell study. "The thing we found most related
to health was formal community participation," she
says. "These things gave people a sense of personal
mastery, self-esteem, satisfaction with life and a higher
energy level. It also was related to a sense of lower
depression." <br><br>In the Cornell survey, the benefits
appeared greater for retirees, not older workers. That's
because people with a job already have a sense of
identification and well-being, says Dr. Moen. Because many
retirees often feel cast aside and feel adrift, regular
volunteering gives a sense of purpose and satisfaction.
<br><br>Jaak Panksepp, Ph.D., a distinguished professor of
psychology at Bowling Green State University in Ohio, has
done research on the effects of social interaction on
brain chemicals in laboratory mice. He found that
social interaction similar to volunteering activates the
production of neurochemicals associated with feeling good.
In theory, the same may be happening in humans who
volunteer. However, Dr. Panksepp is cautious about
extrapolating those findings and believes that more research
needs to be done in this area.
<br><a href=http://www.delphi.com/medical/messages/?msg=13975
Hi,<br><br>I just noticed this post and I don't
know this guy at all.<br>Oh, and the site has been
expanded and is now Leona's Hep-C
Haven.<br><a href=http://www.delphi.com/hepcforum1/start
target=new>http://www.delphi.com/hepcforum1/start</a><br>Come join us!<br>We do
our morning thing and evening
is busy too in the chat room. I have made this site
my home for research, postings, and
chatting.<br>Quality and not so much quantity is what we are striving
for, and there are many family of heppers there that
are members that are active.<br>The battle against
the dragon continues, and there's almost not enough
room in cyberspace...lol<br>LOVE<br>Leona
Hi,<br>I'm glad I found this site again, it's
good to see old friends still fighting the
dragon.<br>On this topic I feel real strongly about and created
a page to make the teens think first about what
they are
doing:<br><a href=http://www.bugbear.net/justice/tatpierce.html
target=new>http://www.bugbear.net/justice/tatpierce.html</a><br><br>I know it's
a bit harsh but it's mostly the truth,
I did some research and there are no real
guidelines set up to protect teens. I don't think OSHA is
involved much in it either.<br>I know there are safe
parlors, that practice universal precautions and use
controls on thier autoclaves, but I still don't think
teens think enough about it when they go about doing
these things to themselves.<br>Randi, I hope you are
doing okay, I read your poem in Hep magazine and was
moved to tears.<br>HUGS,LOVE,AND PEACE<br>Leona
Hep chats ;-)<br><br>Looking for someone to talk
to??? Check out these rooms!<br><br>Just a reminder
about the SATURDAY night chat at 10PM EST. Come one
come all to
<a href=http://www.delphi.com/HepCingles
target=new>http://www.delphi.com/HepCingles</a><br>Singles and people who want
to flirt should meet in the
*Hepcat Hideout*<br>><br>There is a second room for
everyone (including married people) to come for support
and darn good company .......It is the *Hep C chat
room for ALL* ... come on by and check it out :-) If
no one is there when you enter....... just hang for
a few and someone will show up
:-)<br>><br>ATTENTION WEB TV USERS!!!!!!!! NEW ROOM!!!!! THURSDAY at
10PM EST!! MEET EACH OTHER THERE!!! and decide on a
regular night ...... no more frustration from NOT being
able to log onto delphi, yahoo, etc.......... you can
TALK
HERE!!!<br><a href=http://jchat.talkcity.com/ChatLauncher?room=hepsingles
target=new>http://jchat.talkcity.com/ChatLauncher?room=hepsingles</a><br><br>You
an also get on IRC to chat. Its a non moderated
chatroom. To connect go to MJ's chat page the url is
below<br><a href=http://www.geocities.com/southbeach/breakers/7277/mjsmirc.html
target=new>http://www.geocities.com/southbeach/breakers/7277/mjsmirc.html</a><br\
><br>There is a Java Applet and a Web TV connection. If
there isn't any one in the hep chatroom just hang out
someone will show up. It is #hepatitis<br><br>Also 24/7
you can go
to<br><a href=http://forums.delphi.com/hepc/start/
target=new>http://forums.delphi.com/hepc/start/</a><br><br>Also a reminder to
web tv users.......... you can all
go to the *old* chatroom at
<a href=http://www.diac.com/~ekwall2/hepchat
target=new>http://www.diac.com/~ekwall2/hepchat</a><br>and talk with each other
there. It IS web tv
accessible :-) AND the robot is there :-) Say the word
*alone* and you won't be :-)<br><br>For a MONDAY night
chat........... go
to<br><a href=http://forums.delphi.com/hepcforum1/start
target=new>http://forums.delphi.com/hepcforum1/start</a><br>It starts about 7PM
EST but you west coasters check
in when you can........<br>they will probably still
be talking!!!<br><br><br><br>If anyone else has a
room and time to add please let me know and
Happy<br>Chatting All....... let's support each other!!!
I just wanted to say thanks to all the GREAT
Heppo's I met in Colo. Sprgs.<br>My son Douglas, my
friend Tim and I had a<br>super time. I wish everyone
the best and have a GREAT
Summer.<br>Glenn<br>akacoloradoprareedog
I hate to appear stupid........ but who is WLB???
and i can say from experience working in a shrinks
office for years...... that even when you lend that ear
and that shoulder it doesn't stop someone from doing
something they are intent on...... so please don't feel any
guilt if this was someone from the lists that you or
others feel that you slighted...... heck..... we all
feel that way from time to time (i think hep makes us
paranoid LOL) anyway, i am sorry to hear someone was
thinking of a permanent solution to a temporary
problem...... just curious if it is someone i know and if he is
all right?? TTYL<br><br>peace and love,<br>pam
guess you know what happened to WLB...he slashed
his wrists.We want people to be tolerant of our
illness yet when someone is suffering from something
other than what we have we trash him...I feel like a
heel for not talking to him.I have to live with
that.But then there were those who laughed because he hurt
himself....cold-hearted.How can we expect to be treated fairly if we do not
do the same....he was hurt and only needed a
shoulder...and I am guilty too.
Randi,<br>Are you gonna continue to keep this
site or is everything gonna be posted at yahoogroups
now?<br><br>I can't keep up with much these days LOLOL<br>so
was just curious if I went ahead and joined the new
one if I could go ahead and unsubscribe from this
one????<br><br>Thanks,<br>Cindy
Randi!!!<br>That is so cute! :):):)<br><br>You
are such a brave trooper!! :)<br>I really admire your
strength & courage!<br><br>Hey...I loved the pictures
too!!! I enjoyed viewing them all and I added a couple
of my own.<br>Michele, you have a sweet little girl!
:)<br><br>I don't post much to you all but I read most all
the informational things you & others
post!<br>Wonderful information....I really appreciate
it!<br><br>When I first saw the picture of Andi & others that
said Central City...I thought wow! Wonder if that is
Central City, KY then I saw the one of you & George and
it said the same thing so I knew then there was
another CC.<br><br>I don't know much, not much happening
around here...just was checking the latest news...I see
a post about the site moving???<br>Haven't read it
yet but I will here in a bit!<br><br>God bless you
Randi; you are looking well! I hope you're feeling
rather well also! <br>Take peace &
strength!!<br><br>HUGS!<br>Cindy
Hi, I'm so happy you stopped in... I've just
recently moved so please note the new address. The Yahoo
groups allow me to post a long message without having to
do it in more than one post. Plus this will also
combine my site with my mailing list. Please come on over
to:<br><a href=http://groups.yahoo.com/group/HepRandiSupportForHepatitis
target=new>http://groups.yahoo.com/group/HepRandiSupportForHepatitis</a><br><br>\
Sure hope to see you there.<br><br>Peace/Love<br>Randi
Hepatology January 2001 (Volume 33, Number
1)<br>The Role of Liver Biopsy in Chronic Hepatitis<br>C
Saadeh S, Cammell G, Carey WD, Younossi Z, Barnes
D,<br>Easley K Hepatology. 2001;33:196-200Hepatitis C is
a<br>leading cause of chronic liver disease
worldwide.<br>While over 80% of those patients who are
acutely<br>infected will subsequently develop chronic
disease,<br>only 20% to 25% will progress to end-stage
liver<br>disease and its complications. The diagnosis of
hepatitis<br>C is confirmed by positive hepatitis C
virus<br>(HCV) serologies -- anti-HCV antibodies
or<br>detectable HCV RNA. In the high-risk individual
with<br>elevated serum aminotransferases, anti-HCV tests have<br>a
positive predictive value of <br>greater
than<br>95%. These studies may be complemented with
HCV-RNA<br>testing to make the diagnosis of chronic hepatitis
C<br>with viremia. However, at present, there are
no<br>accurate noninvasive markers of disease activity
and<br>fibrosis. In this setting, liver biopsy has been used<br>to
exclude other liver diseases <br>and to
determine<br>the histologic stage of disease. Although data
from<br><br>sequential liver biopsies can provide important
information<br>regarding prognosis and potentially help guide
the<br>management of patients with chronic <br>disease,
liver<br>biopsy is still an invasive procedure with
associated<br>morbidity, mortality, and high cost. Therefore, Saadeh
and<br>colleagues conducted this study to evaluate the
utility<br>of liver biopsy in patients with
chronic<br>hepatitis C, and also calculated a cirrhosis
discriminant<br>score to predict cirrhosis in this
population.<br>Records of patients infected with HCV seen at
the<br>Cleveland Clinic Department of Gastroenterology
between<br>January 31, 1990 and February 1, 1997 were
assessed<br>for the following inclusion criteria: (1)<br>abnormal
alanine aminotransferase level (defined as ><br>40
IU/L on at least 2 separate occasions);
(2)<br>positive enzyme-linked immunosorbent assay antibody<br>for
HCV; and (3) had liver biopsy performed
after<br>serologic testing. One hundred twenty-six patients
met<br>inclusion criteria and were enrolled in
the<br>study.Overall, results reaffirmed the value of liver
biopsy<br>in patients with chronic liver disease.
Findings<br>suggest that after serologic testing indicates
HCV<br>infection, liver biopsy still has an
important,<br>adjunctive role in determining the stage of disease.
Data<br>from liver biopsies showed that there were
no<br>alternative diagnoses (0/126) and that
additional<br>diagnoses were rare (3/126; all of which were variants
of<br>nonalcoholic steatohepatitis). These investigators
also<br>confirmed that liver biopsy was superior to
the<br>discriminant score in predicting cirrhosis. The most
frequent<br>complication of liver biopsy observed in these patients
was<br>pain (generally mild).As these study
authors<br>conclude, until accurate and indirect markers
of<br>fibrosis (ie, noninvasive) are developed and
validated,<br>liver biopsy remains important in the management
of<br>most hepatitis C patients.
Help Available for Depression Triggered by
Interferon <br>Antidepressants Make This Cancer, Hepatitis C
Therapy More Bearable <br>By L.A. McKeown <br>WebMD
Medical News <br>Reviewed by Dr. Jacqueline Brooks
<br>March 29, 2001 -- For some people with hepatitis,
certain cancers, and <br>multiple sclerosis, drugs
designed to extend life also can spoil its quality.
<br>Interferon alpha, a drug used to fight these diseases, can
cause a crippling <br>depression. New research now
shows that taking an antidepressant for a few
<br>weeks, before starting treatment, can reduce this
likelihood. <br>When people with the skin cancer malignant
melanoma were given the <br>antidepressant Paxil for two
weeks before they started chemotherapy with
<br>high-dose interferon, only 11% developed depression
compared with 45% of <br>those who did not receive Paxil
before interferon therapy. <br>Depression associated
with high doses of interferon is very common, but
<br>patients shouldn't have to suffer through it or accept it
as part of their <br>treatment. <br>Andrew H.
Miller, MD, of the department of psychiatry and
behavioral sciences <br>at Emory University School of
Medicine in Atlanta, says doctors have assumed <br>for
years that depression associated with cancer is
psychological. But his <br>small study of 40 patients is further
proof that the therapies themselves can <br>induce
depression. <br>"About 33% of patients who started on the
interferon had to stop because the <br>depression was so
severe," says Miller, lead author of the research, which
<br>appears in the March 29 issue of The New England Journal
of Medicine. "We <br>tend to ... have patients grin
and bear it. We also have a tendency to expect
<br>people to be depressed because they have cancer."
<br>The good news, he says, is Paxil and other
antidepressants not only help <br>alleviate the depression that
could cause people to stop treatment, but also <br>help
in other ways. Study participants who took Paxil
before undergoing 12 <br>weeks of interferon treatment
reported less pain and fewer stomach problems. <br>They
also reported less confusion, distractibility, or
memory problems and <br>slightly less fatigue than
people who didn't get the antidepressants. <br>"I think
patients should be aware of this, and they should think
long and <br>hard about whether they want to take
advantage of a treatment that may keep <br>them in a state
where they will still feel like being with family and
friends <br>and still functioning at some level while
[undergoing therapy]," Miller says. <br>"Depression is not
just sadness. People can become irritable -- they
become <br>difficult, ... that can cause tension within
the family."
Friday April 27 3:09 PM ET<br>Enzon Up After
Setback for Roche Drug <br><br>By Ransdell
Pierson<br><br>NEW YORK (Reuters) - A regulatory setback for a
hepatitis C drug developed by Roche Holding AG (ROCZg.S)
spelled good news on Friday to tiny rival drugmaker Enzon
Inc. (NasdaqNM:ENZN - news), whose shares surged on
the news.<br><br>Swiss drugs group Roche on Friday
said the U.S. Food and Drug Administration had
requested more information about clinical trials of its
experimental treatment, Pegasys.<br><br>That created concern
among investors that Roche's expected U.S. approval for
Pegasys late this year might be delayed, giving
Piscataway, N.J.-based Enzon and partner Schering-Plough
Corp. (NYSE:SGP - news) that much more time to make
inroads with their recently launched new therapy called
Peg-Intron.<br><br>``This is very good news for Schering-Plough and Enzon,
because it could extend their advantage of having the
first product to market,'' said Ivonne Marondel, a
biotech analyst for Gerard Klauer Mattison & Co. who
added that clinical trial results have previously
suggested that Peg-Intron and Pegasys have similar safety
and efficacy.<br><br>``The FDA has asked questions
about Roche's clinical designs and details which were
never asked of Schering-Plough,'' she said, which
suggests Pegasys could suffer regulatory delays as Roche
strives to satisfy the unspecified FDA
concerns.<br><br>Shares of Enzon were up $6.49 or 12.88 percent to $56.87
in afternoon activity on the Nasdaq. It has traded
in the past year in a range between $24.62 and
$84.12.<br><br>Schering-Plough, unlike Enzon, has a wide line of other
prescription drugs. Its shares edged up 11 cents to $38.90 on
the New York Stock Exchange.<br><br>About 4 million
Americans are believed to be infected with the hepatitis C
virus, which quietly attacks and can seriously damage
the liver for decades before symptoms occur. It is
the biggest cause of liver transplants in the United
States and only an estimated 100,000 Americans are now
being treated for the nation's most common serious
blood-borne infection.<br><br>Enzon is best known for its
``pegylation'' technology, in which drugs are linked to the
chemical polyethylene glycol (PEG) in order to make them
last longer in the bloodstream -- thereby reducing the
frequency of needed doses.<br><br>New Jersey-based
Schering-Plough has licensed Enzon's technology to create a
longer-acting ``pegylated'' form of Schering-Plough's
interferon drug, Intron A, that it has recently begun
selling under the name Peg-Intron as a stand-alone
treatment for hepatitis C.<br><br>Enzon is entitled to
receive a 7.5 percent royalty from Schering-Plough on all
Peg-Intron sales, according to some analyst
estimates.<br><br>Injections of Peg-Intron, approved in January by the FDA,
are only needed once a week rather than the
thrice-weekly regimen for Schering-Plough's older
Intron-A.<br><br>One of Schering-Plough's biggest products, Rebetron,
is a combination product for hepatitis C that
combines Intron-A with an antiviral pill called ribavarin.
The combo, considered the current ``gold standard''
of treatment, had estimated global sales over $1
billion in 2000 and Schering-Plough is now awaiting FDA
approval for an improved combination that would pair
Peg-Intron with ribavarin.<br><br>The improved combo
therapy, which lasted longer and was more effective than
Rebetron in clinical trials, could be approved by August
and become the new standard of treatment. It could
generate annual sales of $3 billion within five years, by
some estimates.<br><br>But Roche has been hot on
Schering-Plough's heels, aiming to cash in on the lucrative and
expanding hepatitis C area by selling Pegasys, its
different pegylated form of interferon.<br><br>``Enzon may
really benefit because this is a race for time, and to
the winner go the spoils. This is a huge product area
and whoever gets on the market first will dominate
it, not only in the short term but in the long
term,''
"The problem is we don't know exactly which
issues have been raised. We <br>only know it is not a
safety issue, which is good news," said Birgit
<br>Kulhoff at Lombard Odier. <br><br>She said Roche told
analysts it can respond to the issues by "summer," so
<br>the best-case scenario is still for a rollout late
this year and the worst <br>case is the second quarter
of 2002. <br><br>Denise Anderson at Bank Julius Baer
said Roche must have known all along <br>that some
issues were still open or else it would have not have
forecast a <br>fourth-quarter launch for a drug expected
to get FDA approval by May. She <br>stuck to her
forecast the drug would generate 900 million francs in
sales <br>by 2004. <br><br>It is the latest in a series
of late-stage problems for Roche drugs. <br><br>It
halted developing a promising Alzheimer's drug in 1999
when some <br>patients had liver problems during
trials. In 1998 it had to pull heart <br>drug Posicor and
sharply restrict sales of Parkinson's drug Tasmar amid
<br>concerns about side effects. <br><br>"If it's a company
where everything is going along more or less OK, a
<br>well-oiled machine, something like this is frankly part of
doing <br>business," Anderson said. <br><br>"If you
have a company like Roche where this is a vital launch
-- if this <br>launch doesn't go well the company is
totally dead -- then there is a lot <br>of psychological
impact." <br><br>But she said the problem did not put more
pressure on Roche to do a big <br>deal unless the drug
flops when it is launched. <br><br>Kulhoff said the
focus now was on data Roche is set to present in May on
<br>the efficacy of Pegasys in combination with
ribovirin. This is important <br>because Schering-Plough
Corp is already on the market with its monotherapy
<br>pegylated interferon and has already filed combination
data. <br><br>"With this delay Roche has a chance to
get meaningful market share only if <br>the
combination data are good," she said. <br><br>07:25 04-27-01
<br>Copyright 2001 Reuters Limited. All rights reserved.
"The problem is we don't know exactly which
issues have been raised. We <br>only know it is not a
safety issue, which is good news," said Birgit
<br>Kulhoff at Lombard Odier. <br><br>She said Roche told
analysts it can respond to the issues by "summer," so
<br>the best-case scenario is still for a rollout late
this year and the worst <br>case is the second quarter
of 2002. <br><br>Denise Anderson at Bank Julius Baer
said Roche must have known all along <br>that some
issues were still open or else it would have not have
forecast a <br>fourth-quarter launch for a drug expected
to get FDA approval by May. She <br>stuck to her
forecast the drug would generate 900 million francs in
sales <br>by 2004. <br><br>It is the latest in a series
of late-stage problems for Roche drugs. <br><br>It
halted developing a promising Alzheimer's drug in 1999
when some <br>patients had liver problems during
trials. In 1998 it had to pull heart <br>drug Posicor and
sharply restrict sales of Parkinson's drug Tasmar amid
<br>concerns about side effects. <br><br>"If it's a company
where everything is going along more or less OK, a
<br>well-oiled machine, something like this is frankly part of
doing <br>business," Anderson said. <br><br>"If you
have a company like Roche where this is a vital launch
-- if this <br>launch doesn't go well the company is
totally dead -- then there is a lot <br>of psychological
impact." <br><br>But she said the problem did not put more
pressure on Roche to do a big <br>deal unless the drug
flops when it is launched. <br><br>Kulhoff said the
focus now was on data Roche is set to present in May on
<br>the efficacy of Pegasys in combination with
ribovirin. This is important <br>because Schering-Plough
Corp is already on the market with its monotherapy
<br>pegylated interferon and has already filed combination
data. <br><br>"With this delay Roche has a chance to
get meaningful market share only if <br>the
combination data are good," she said. <br><br>07:25 04-27-01
<br>Copyright 2001 Reuters Limited. All rights reserved.
By Michael Shields <br> <br>ZURICH, April 27
(Reuters) - Roche Holding AG's patchy reputation in
<br>bringing new drugs to market was dealt a fresh blow on
Friday after U.S. <br>regulators sought more information
on clinical trials for a key new drug. <br><br>The
company said it still hoped to launch hepatitis C
medicine Pegasys on <br>schedule, but could not rule out a
delay. <br><br>The stock market reacted poorly to news
of a potential stumble in rolling <br>out the Swiss
drug and diagnostics group's most important new
medicine <br>this year. <br><br>Traders said the news
could add pressure on Roche to do a major
<br>acquisition or merger to bolster its weak product pipeline,
but financial <br>analysts argued it was too early to
hit the panic button until the problem <br>with
Pegasys was clearer. <br><br>Roche certificates, which
have been fallen as much as 30 percent this year
<br>amid slack sales at Roche's flagship drugs division,
fell 4.4 percent to <br>11,750 Swiss francs before
recovering somewhat to 12,045 in a generally <br>weaker
market. <br><br>"We hope that (a delay) is not going to
happen. This depends on the <br>quality of the questions.
Our experts are looking into this now," a Roche
<br>spokesman said. <br><br>"I would not say there is an
immediate delay to the whole thing. This <br>cannot be
completely ruled out, but there is not an immediate
indication <br>for that," he added. <br><br>This depended in
part on when talks with the U.S. Food and Drug
<br>Administration could take place. <br><br>Roche had applied last
May for U.S. marketing authorisation of Pegasys, a
<br>longer-lasting version of its interferon drug Roferon-A that was
expected <br>to be one of its key sales drivers at a time
of listless pharmaceutical <br>turnover growth.
<br><br>It had expected to start selling the drug in the
U.S. market in the fourth <br>quarter of 2001.
Analysts have estimated the drug could have annual sales
<br>of close to a billion francs by 2004.
<br><br>Commerzbank said in a research note that it was downgrading
Roche to <br>"accumulate" from "buy" and cutting its
price target to 14,000 francs from <br>15,500 given a
development that it said could well result in a roughly
<br>six-month launch delay. <br><br>The Roche spokesman said an
FDA review panel had raised questions about
<br>clinical trial data for Pegasys, which uses a molecule
developed and <br>produced by U.S.-based Shearwater Corp.
<br><br>"As is expected in these filings and reviews they are
coming up with some <br>additional questions on the
clinical data. This is quite usual for such an
<br>application. We will provide additional information and the
procedure goes <br>on," he said. <br><br>LIBERATING BLOW?
<br><br>The stock market buzzed with speculation Roche would
strike a liberating <br>blow from its current pipeline
woes by making a big acquisition, perhaps <br>of
Germany's Schering AG. <br><br>They cited Roche's $12
billion cash pile that company officials have said <br>it
will not hoard forever but eventually use to bolster
its core <br>businesses. <br><br>"Now Roche is really
under pressure finally to do something," one share
<br>trader said. <br><br>But Roche executives have also said
they will not do a big deal just to <br>spur sluggish
drug sales, and analysts said the jury was still out
on how <br>bad the Pegasys problem was.
} Sharps Compliance Offers New Safe Disposal
System for Home Users of<br>Needles, Syringes; Users in
8% of U.S. Homes Create Hazards
for<br>Community-Wide Infection<br><br><br> April 27,
2001<br><br><br><br> HOUSTON--(BUSINESS WIRE)--April 26, 2001 via
NewsEdge<br>Corporation -<br><br> Sharps Compliance Corp. (OTCBB:SCOM)
has completed an<br>agreement with Waste Management,
Inc. (NYSE:WMI) to begin a pilot program to<br>provide
safe disposal systems for individuals who use needles
or syringes in<br>their home. Under the program,
Waste Management will make the Sharps<br>Disposal by
Mail(TM) System available to Waste Management customers
in<br>Orange County, Calif., Denver, and Orlando, Fla.<br><br>
"The primary focus of this program is to
help<br>self-injectors handle these hazards safely in the home," said
Dr. Burt<br>Kunik, president and CEO of Sharps
Compliance Corp. "The system is designed<br>to protect
family members, neighbors and others from injury and
infection."<br><br> More than three percent of the U.S. population
and<br>individuals in eight percent of households use "sharps" --
syringes,<br>needles, lancets, sutures, catheter needles, or any item
that can puncture<br>the skin -- in treating
conditions like diabetes, multiple
sclerosis,<br>infertility, migraines, allergies and hemophilia. Under the
new program,<br>these individuals can order the
disposal system through Waste Management.<br>When the
sharps container is full, it is secured and placed in a
postage<br>pre-paid return box and sent through the U.S. Mail
directly to a resource<br>recovery facility operated by
Sharps Environmental Services of Texas,
Inc.<br>Certified proof of the destruction is then sent to the
individual.<br><br> "This initiative is invaluable for the education
of the<br>public on the safety issue of protecting
others," said Kathy J. Berkowitz,<br>president-elect of
the American Association of Diabetes Educators.
"Each<br>day, our diabetes educators are asked by patients how
to handle used needles<br>safely."<br><br> The
Sharps Disposal by Mail(TM) System is easy to use
and<br>meets all state and federal regulations. For more
information on the system,<br>call 1-877-WASTEMD.<br><br>
Waste Management, Inc. is its industry's leading
provider<br>of comprehensive waste management services. Based in
Houston, the Company<br>serves municipal, commercial,
industrial and residential customers<br>throughout North
America.<br><br> Headquartered in Houston, Sharps Compliance Corp.
is the<br>nation's leader in designing
cost-effective, regulatory-compliant systems<br>for containment,
transportation, destruction, and tracking of medical
waste<br>generated in the home health care setting. Sharps
Compliance Corp.'s common<br>stock trades on the OTC
Bulletin Board under the symbol SCOM. For
further<br>information, visit the Sharps Web site at
www.sharpsinc.com.<br><br> Any forward-looking statements in this release
are made<br>pursuant to the "safe harbor" provisions
of the Private Securities<br>Litigation Act of 1995.
Investors are cautioned that actual results may<br>differ
substantially from such forward-looking statements.
Forward-looking<br>statements involve risks and uncertainties including, but
not limited to,<br>continued acceptance of the
Company's products and services in the<br>marketplace,
competitive factors, new products and technological
changes,<br>dependence upon third-party vendors, customer relations,
government<br>supervision and regulation, changes in industry practices,
changes in<br>third-party expense reimbursement
procedures, and other risks detailed in<br>the Company's
periodic filings with the Securities and Exchange
Commission.<br><br><br> CONTACT: Sharps Compliance Corp., Houston | Burt
Kunik,<br>800/772-5657 | or | Sommers & Associates, Houston | Tom
Sommers or Melanie<br>Fahey, 713/222-1600
Blood test for hepatitis C devised<br><br>From
AFP<br>22apr01<br><br>01.40 (AEST) A SIMPLE blood test could in future be
used to determine the <br>seriousness<br>of hepatitis
C and avoid liver biopsies that cause many to
refuse treatment <br>of the disease, a<br>French doctor
said today. <br><br>An estimated 200 million people
worldwide are infected with the hepatitis C <br>virus,
which<br>is transmitted through blood or body fluids.
<br><br>Professor Thierry Poynard told the 36th European congress
of the association <br>for liver<br>studies that his
new test analyses five proteins that are present in
large <br>quantities in the<br>blood and which make up
the "memory" of the mechanisms that lead to scarring
<br>of the<br>liver.<br><br>The main effect of hepatitis
C, cirrhosis of the liver, results from the
<br>scarring, or fibrosis,<br>of the liver. Chronic liver
disease affects about two-thirds of those <br>afflicted
with hepatitis<br>C.<br><br>Poynard, who works at the
Pitie-Salpetriere Hospital in Paris, said the test <br>could also
be<br>used in the treatment of other diseases, such as the
milder hepatitis B or <br>alcoholism.<br><br>At present,
the only method of determining the extent of the
fibrosis is <br>through a biopsy,<br>which involves
doctors taking a tissue sample from the liver using a
long <br>needle.<br><br>Poynard said the biopsy causes
major pain in about 30 per cent of those <br>undergoing
the<br>procedure, and results in serious accidents in three per
cent and in death in <br>about three out<br>of 10,000
patients.<br><br>He quoted a recent study that said about 50 per cent
of hepatitis C sufferers <br>refuse<br>biopsies.
This fear of biopsies explains why so few of those
stricken with <br>the disease seek<br>treatment, Poynard
said.
<br><br><a
href=http://news.com.au/common/story_page/0,4057,1919039%255E1702,00.html
target=new>http://news.com.au/common/story_page/0,4057,1919039%255E1702,00.html<\
/a>
Pegylated Interferon, Better Molecular Tools
Improve Outcomes <br><br>April 23, 2001 <br><br>Treatment
and outcomes for patients with chronic hepatitis
(HCV) continue to improve with the recent approval of
pegylated interferon. <br><br>An expert panel, convened by
the American College of Gastroenterology (ACG) on
April 6, 2001, met in Dallas, Texas, to discuss the
most recent data in the field of hepatitis diagnosis
and treatment. <br><br>With a huge expansion in
scientific knowledge relating to diagnosis and treatment of
hepatitis B and C, the ACG symposium brought together
experts on hepatitis and liver disease. The prime
objective of the symposium was to prepare treatment
approaches and recommendations, reflecting the latest
scientific advances that could be applied by individual
gastroenterologists as they encounter patients with hepatitis in
their day-to-day practice. <br><br>The panel of 16
experts presented the most recent data on a number of
recent developments relating to hepatitis. <br><br>The
recent conference compiled critical treatment data
spanning new developments: * on molecular tools to measure
response to therapy for hepatitis C (e.g., TMA diagnostic
test recently available through Bayer Diagnostics); *
on two new pegylated interferons (Roche's Pegasys
and Schering's PEG Intron); and * ways to optimize
treatment outcomes for patients treated for chronic
hepatitis C (i.e., Procrit for ribavirin induced hemolytic
anemia). <br><br>Because of the critical advances in these
new diagnostic and therapeutic advances, which it is
believed may increase success rates by at least 30%, the
results of the meeting will be sent to all 7,500 ACG
member physicians in the form of a CD-ROM, with other
follow-up educational materials in the works. <br><br>This
article was prepared by Hepatitis Weekly editors from
staff and other reports. <br><br>To see more of the
NewsRx.com, or to subscribe, go to <a href=http://www.newsrx.com
target=new>http://www.newsrx.com</a> .