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Week Ending: February 12th, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Malaysia to Use Vaccine from Cuba
• Youth Delegates Head to Hep C Symposium
• Larger Gains Sought in Hepatitis C Treatment
• Metabasis Announces Publication of an Article that Reports Evidence that HepDirect Prodrugs Represent a Strategy for Targeting Drugs to the Liver
• Group to Fight for Stem Cells
• Union Points to Benefits Of Safer Needles
• GlaxoSmithKline: Hepatitis B Vaccine Fendrix Gets EU OK
• Many Hepatitis C Lawsuits Settled
• Clinic to Offer Heroin, Despite US Needling
• Antiviral Treatment Seems Effective in Some Hepatitis C-Associated NHL
• InterMune's Hepatitis Strategy Gets the Right Response
• Doctors Issue Hepatitis B Warning
• India's Vaccines Come with Risk: Dirty Needles Used for Immunization Can Spread Other Diseases
• MCAVN Fund-Raiser Turns 18
• MIGENIX Inc. (MGI.TO) Releases CEO Message; Provides Update on Major Clinical Programs
• Vancouver Clinic to Offer Heroin on Prescription
• Insurance Help for Transfusion Victims Planned
• Chua: Cuban Medical Success Can Be Emulated
• Hepatitis C, a Silent but Deadly Killer
• Herbal Remedy as Good as Drug for Depression: Study
• Another Javed Suit Is Settled
February 6th, 2005
Malaysia to Use Vaccine from Cuba
SourceURL:http://www.nst.com.my
By Nurjehan Mohamed
Malaysians will be able to benefit from a low-priced Hepatitis B vaccine from Cuba by next month. The cheaper alternative will initially be given to child patients at public hospitals. The vaccine will gradually be made available to more patients.
The vaccine is the latest fruit of the close diplomatic ties between Malaysia and Cuba for 30 years.
Cuban ambassador Pedro Monzon Barata said the two countries would also be furthering cooperation in other fields of science and technology, as well as sports.
He added that there would be different activities throughout the year to celebrate the 30th anniversary of the country's relations with Malaysia.
Among them are art and photography exhibitions to be held in Malacca, Kuala Lumpur and Penang, the screening of Cuban films and exchange programmes among students and businesses.
He said he would like to see improved tourism between the two countries as the industry had suffered setbacks in recent years with the Iraq war and SARS virus threat.
He was speaking at a Press conference after launching the 30th anniversary celebration at Westin Hotel.
Minister of Foreign Affairs Datuk Seri Syed Hamid Albar, who was also at the launch, said while relations between the two countries had grown over the last 30 years, the last five years had seen the greatest growth in bilateral ties.
"Aside from strong political ties, I think what is most important is strong relations in science, education and biotechnology, areas where we could learn from the Cubans."
He said there was a lot of benefit that Malaysia could gain from having very close and strong relationship with Cuba.
"Cuba has done very well under very difficult circumstances. There is much to be learnt from countries who have undergone all sorts of difficulties and survived well," he said.
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Youth Delegates Head to Hep C Symposium SourceURL:http://www.northernlife.ca
BY HEIDI ULRICHSEN
heidi@northernlife.ca
Brian Slegers wants everyone to learn about the risks of hepatitis C. The virus, which is usually transmitted through intravenous drug use or dirty tattoo needles, can cause serious liver damage.
Brian Slegers (middle), national chair for the hepatitis C Youth Planning Committee, is going to the national youth symposium on the disease, along with Renelle Tousignant and Victor Shaganash.
That's why the Slegers, 27, has joined with other youth in organizing the second annual National Youth Symposium on hepatitis C, which is being held in Ottawa Feb. 26-27.
He's bringing eight Sudbury-area youth and one university professor along with him to the government-sponsored conference as delegates, and hopes they in turn will increase awareness of the disease.
The conference is mostly for youth workers wanting to become informed about hepatitis C, but youth at risk of contracting the disease will also be there.
"It is a big problem," says Slegers, who works for Access AIDS and the Sudbury Metis Council. "It’s hard to determine how many are infected because we (just) have the people who have been tested. But a lot of people don't get tested. In Sudbury rates are high and somewhat alarming."
In 2004, the Sudbury & District Health Unit reported 115 cases of hepatitis C, which is probably just a fraction of the actual cases in the community.
Slegers says it's important to learn more about the debilitating disease, because it can be treated with drugs. However, there is no immunization against the virus, unlike related hepatitis A and B.
"A lot of people when you...start talking about hep C, they say, 'I already have the shot for that.' You can't get a shot for hep C. That's hep A and hep B...They don't think it's a deadly disease."
Sympoms of the disease appear slowly after infection, and can include fatigue, jaundice, and severe cirrhosis of the liver.
Aboriginal people are especially at risk of getting hepatitis C, says Slegers, because deficiencies in their health care and educational systems ensure they don't always get enough public health information.
That's why Sudbury Secondary School student Victor Shaganash, 18, is going to the conference. He says he wants to learn more about the disease, and distribute the information among other aboriginal people in his hometown of Hornepayne.
"I myself do not (know anyone with the disease)...but apparently natives have a high population of hepatitis," he says.
Laurentian student Adam Koleman, 21, also has personal reason for attending the conference. One of his family members has hepatitis C.
"It's not just hepatitis C. They also have a lot of other illnesses, so it's hard to see just what hepatitis C is doing to them," he says. "But just with the illnesses that they're dealing with, it's hard for them to hold a job. They have to go on disability."
Koleman, who is Metis, thinks he has a responsibility to help other youth learn about hepatitis C. Youths are more likely to listen to their peers, he says.
"We're kind of like leaders to the community. It sounds like a good way of doing it...You can go back, and if I know someone who uses needles for drug use...I can shine some light for them to prevent it," says Koleman.
"That's the only way a problem like this can be dealt with...Youth on youth is going to work. Who are youth really going to listen to? They don't really want to listen to older people."
Koleman says he's excited about the conference because he'll meet youth from all over Canada, and get the chance to hear the stories of people who live with hepatitis C.
Student nurse Raegan Humphrey, 24, says she became interested in the disease after doing a placement at Access AIDS, where she worked with a hepatitis C support group under Slegers.
"I see, now that I've been exposed to it through Access AIDS, how many people it affects in our community," she says.
"I think this is a great educational opportunity to not only inform people in my immediate surroundings, but also bring that information back to Cambrian and Laurentian students so they also know more about it."
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February 7th, 2005
Larger Gains Sought in Hepatitis C Treatment SourceURL:http://www.ama-assn.org
By Susan J. Landers
Despite some success, the viral disease is still the most common chronic bloodborne infection in the United States.
Washington -- There are still gains to be made in the treatment of hepatitis C, and a recent congressional hearing on the disease as well as a National Institutes of Health workshop to discuss a vaccine to fight this liver-ravaging condition hold out hope for more progress.
"In the last 10 years, we've quadrupled the treatment response rate," said Michael Bernstein, MD, director of the Hepatitis Clinic at Coney Island Hospital in Brooklyn, N.Y.
There is now an overall success rate of about 55%, researchers say. Treatment with long-acting interferon or a combination of interferon and other antiviral drugs has made the difference.
"We are still, however, left with those unfortunate 45% who don't respond," said Adrian M. DiBisceglie, MD, chief of hepatology at Saint Louis University School of Medicine.
And that's a lot of people. Hepatitis C is the most common chronic bloodborne infection in the United States. About 4 million Americans are chronically infected, and most are not even aware of this threat to their health.
Primary care physicians have a major role to play in diagnosing the infection, so that those who can benefit from treatment will receive it in time to prevent extensive liver damage, Dr. Bernstein said. The AMA and the Centers for Disease Control and Prevention have collaborated on materials targeted to doctors and patients to help with early diagnosis.
"Hepatitis C was only identified 15 years ago, so we still have much to learn about this disease," said Rep. Tom Davis, (R, Va.), chair of the House Committee on Government Reform. Davis held a hearing on hepatitis C Dec. 14, 2004.
An NIH workshop on vaccine development was scheduled for Feb. 1 and 2.
Early warning system
Hepatitis C infection often presents no warning symptoms, and many people could have unknowingly become infected from intravenous drug use years earlier or from contaminated blood or blood products received before widespread screening for the virus began in the early 1990s.
The virus is sometimes only discovered after a patient exhibits signs of serious liver disease, such as cirrhosis or liver cancer, Davis said.
Still, the forward march of treatment has resulted in substantial gains for many of those infected. "We started out treating patients with hepatitis C in the mid-80s with interferon," Dr. DiBisceglie said. At that stage, no more than 5% to 10% of patients had a sustained virologic response, he added.
Treatment refinements made since then include the use of combination therapy with pegylated interferon and ribavirin that extends the life of interferon, thus allowing it to fight the virus longer.
Today's positive outcomes jump even higher for those infected with one of the less common viral genotypes. For those infected with genotype 2 the success rate is probably 90%, and for genotype 3, it's about 70% to 80%, Dr. Bernstein said.
However, treating genotype 1 infections, the most common of the viral types, has not met with as much success. African-Americans, for whom the cure rate is the lowest, are most frequently infected with this genotype.
But it isn't just infection with genotype 1 that is making the difference in this population, Dr. DiBisceglie said. "Even if you account for genotype, the response rate is less than in whites," he said. While about 40% of whites with the genotype respond to treatment, the level drops to 30% to 40% for African-Americans. Studies are under way to examine the possible reasons for the poorer response rate.
A lesson can be drawn from this conundrum, said Stanley M. Lemon, MD, professor of microbiology and immunology at the University of Texas Medical Branch in Galveston and director of the Hepatitis Research Center there.
Overall cure rate for hepatitis C is about 55%.
That lesson is to include all populations in clinical studies, he said. "If you have selected populations that don't really need to be treated by the drug, you are going to lose valuable information."
Work also has been ongoing to develop an effective vaccine, and some candidates are currently being tested. But the complex nature of the virus presents many obstacles.
"The problem is, like the AIDS virus, the envelope proteins you would likely target mutate very quickly," Dr. Bernstein said, which makes it much more difficult to design a vaccine. In contrast, proteins in hepatitis B, for which a successful vaccine has been developed, are much less variable.
Dr. Lemon finds promise in the development of small molecule antiviral inhibitors, which have been shown to cause a sharp drop in hepatitis C viral levels in a short time. Although studies of one such drug were halted because of high toxicity, others could meet with more success. "The importance of those studies, even if that drug never makes it to market, is that small molecule therapy, antivirals like we have for HIV and herpes, are nearing reality and have incredible potential," Dr. Lemon said.
Diagnosing guidelines
The Dept. of Veterans Affairs recommends that patients be tested for hepatitis C if they either have expressed a desire to be tested or have one or more of the following risk factors:
•Vietnam-era military service
•Blood transfusion before 1992
•Current or past use of intravenous drugs
•Unequivocal blood exposure of skin or mucous membranes
•History of multiple sexual partners (more than 10 partners)
•History of hemodialysis
•Tattoos or repeated body piercing
•History of intranasal cocaine use
•Unexplained liver disease
•Intemperate or immoderate use of alcohol
The AMA on viral hepatitis (www.ama-assn.org/ama/pub/category/2326.html)
A physician's tool kit for hepatitis C developed by the AMA and the Centers for Disease Control and Prevention (www.ama-assn.org/ama/pub/category/13688.html)
Veterans' Administration National Hepatitis C program (www.hepatitis.va.gov)
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Metabasis Announces Publication of an Article that Reports Evidence that HepDirect Prodrugs Represent a Strategy for Targeting Drugs to the Liver
SourceURL:http://www.medadnews.com
SAN DIEGO, February 07, 2005 /PRNewswire-FirstCall/ -- Metabasis Therapeutics, Inc. . (NASDAQ:MBRX) , announced today that an article entitled "Liver-Targeted Drug Delivery Using HepDirect Prodrugs" was published in the February issue of The Journal of Pharmacology and Experimental Therapeutics (JPET 312:554-560, 2005). The article presents evidence that HepDirect prodrugs represent a strategy for targeting drugs to the liver and achieving more efficacious therapies to fight chronic liver diseases such as hepatitis B, hepatitis C and primary liver cancer (hepatocellular carcinoma). The publication reports on preclinical results from studies of two of Metabasis' HepDirect prodrugs, pradefovir mesylate (previously known as remofovir, or MB06866) for Hepatitis B, and MB07133 for primary liver cancer. Both drug candidates are currently being clinically tested in patients.
Dr. Mark Erion, Executive Vice President of Research and Development said, "Based on the preclinical work presented in this article together with early clinical trial results, our proprietary HepDirect technology appears to be a very useful tool for developing effective new therapies for a number of very difficult to treat diseases including many metabolic diseases that involve pathways in the liver. The studies reported on in the JPET article provide further insight into the potential effectiveness and safety of the approach. We are continuing to apply the HepDirect technology internally to develop important new products, including our collaboration with Merck where we are applying HepDirect and other technology to drug compounds provided by Merck that have the potential to treat patients with hepatitis C."
The article is currently available online from JPET's website (http://jpet.aspetjournals.org/) under the Fast Forward Articles section.
About Metabasis (http://www.mbasis.com)
Metabasis Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs principally to treat metabolic diseases linked to pathways in the liver and to treat liver diseases. The company has established a broad product pipeline targeting large markets with significant unmet medical needs. Metabasis has three internally discovered, novel product candidates in clinical development: CS-917, pradefovir mesylate (previously known as remofovir) and MB07133, indicated for the treatment of type 2 diabetes, hepatitis B and primary liver cancer, respectively. All three products are being studied in patients and preliminary evidence of efficacy has been demonstrated with CS-917 and pradefovir mesylate. Metabasis has developed several proprietary technologies for use in discovering and optimizing drugs, including the NuMimetic(TM) technology and the HepDirect(TM) technology. The NuMimetic technology was used to discover CS-917, a first-in-class gluconeogenesis inhibitor, and was also used to identify MB07803, a 2nd generation gluconeogenesis inhibitor that is expected to enter the clinic in 2005 for the treatment of type 2 diabetes. The HepDirect technology, a liver-targeting prodrug technology, was used to develop pradefovir mesylate and MB07133 and is also being used in a partnership with Merck to discover new treatments for hepatitis C. Metabasis is continuing to identify and develop new product candidates using its proprietary technologies and know-how.
Forward-Looking Statements:
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to the progress, goals and success of Metabasis' HepDirect technology and/or products that employ Metabasis' HepDirect technology, and the Company's collaboration with Merck to develop new treatments for hepatitis C, as well as other statements about Metabasis' proprietary technologies, product candidates, research programs and collaborations. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause Metabasis' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to the progress and timing of clinical trials for Metabasis' product candidates; the fact that positive results from pre-clinical studies and early clinical trials does not necessarily mean later clinical trials will succeed; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing Metabasis' product candidates; adverse side effects or inadequate efficacy of Metabasis' product candidates or proprietary technologies; Metabasis' dependence on Merck and its other licensees and collaborators for the clinical development and registration of its product candidates including any product candidates yielded in Metabasis' collaboration with Merck, among other things; the scope and validity of intellectual property protection for Metabasis' product candidates, proprietary technologies and their uses; competition from other pharmaceutical or biotechnology companies; Metabasis' ability to obtain additional financing to support its operations; and other factors discussed in the "Risk Factors" section of Metabasis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2004. All forward-looking statements are qualified in their entirety by this cautionary statement. Metabasis is providing this information as of this date of this release and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.
CONTACT: Paul Laikind, Ph.D., of Metabasis Therapeutics, Inc.,+1-858-622-5550; or Susan Neath of Atkins + Associates, +1-858-527-3486, forMetabasis Therapeutics, Inc.
Web site: http://jpet.aspetjournals.org/
Web site: http://www.mbasis.com/
Ticker Symbol: (NASDAQ:MBRX)
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Group to Fight for Stem Cells SourceURL:http://www.marinij.com
By Keri Brenner, IJ reporter
A Marin man and two other North Bay leaders are forming a new stem cell advocacy and education group to create more clout in working with the larger statewide stem cell organization.
"We want to go in there with great legitimacy and scientific support," said John Ames of Larkspur, executive director of the newly created Pharmacists Stem Cell Council. "It's not a slam-dunk organization."
Ames, a proponent of last year's successful Prop-osition 71 stem cell ballot measure, is joining board members Fred Mayer of San Rafael and Bill Remak of Petaluma in organizing the group.
The new organization will seek to have a voice at public meetings of the 29-member Independent Citizens Oversight Committee, the public arm of the California Institute for Regenerative Medicine. Both entities were formed to administer Proposition 71-approved grants totaling $300 million annually for stem cell research statewide.
On Thursday, officials announced that the California Institute for Regenerative Medicine has leased interim headquarters in Emeryville. The office will be staffed by a new slate of executives and support workers, including some from San Francisco.
"There needs to be visibility and transparency, as well as education for patients and consumers," said Mayer, past president of the Marin County Pharmacists Association and president of San Rafael-based educational nonprofit Pharmacists Planning Services Inc. "That can start with the 6,000 pharmacists in California."
Mayer and the other area leaders say pharmacists can be a stem cell education conduit, because they will ultimately help customers get drugs developed through stem cell research.
"We will work with ICOC to convey information to the public through pharmacists," Ames said. "Also, we will work to advocate for diseases that are not mentioned by name."
Ames said the ICOC had done a "remarkable job getting senior scientists on board" its 29-member committee, but that it was "impossible to cover it all and still have a board that can meet."
Remak, chairman of the California Hepatitis Task Force, said he wants to draw attention to stem cell research's potential to help in cases of liver disease. A hepatitis C sufferer himself, Remak said there is no representation on the ICOC for hepatitis.
"Stem cell research won't deal specifically with hepatitis C virus per se, but it will be able to deal with damage and decay and decompensated liver organs," said Remak, a San Anselmo native who is also chairman of the 21-state National Association of Hepatitis Task Forces. "Hepatitis C is one of the major reasons why people have liver transplants."
Ames got involved in Proposition 71 after his son David, a Corte Madera attorney, contracted ALS, or amyltrophic lateral sclerosis, a degenerative neural disease. His son is in South America seeking treatment.
Ames, Mayer and Remak traveled last week to Washington, D.C., for a three-day conference, Health Action 2005, on grassroots health care movements. Ames, who led a workshop on stem cell research, said there is a need for more education.
"I would estimate that 50 percent of Marin families will at some time experience one of the diseases that stem cell research could help - heart disease, cancer or others," Ames said. "Most of these diseases will level the finances of a house - you think you have a nest egg, you're kidding yourself."
Contact Keri Brenner via e-mail at kbrenner@marinij.com
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Union Points to Benefits Of Safer Needles
CBC News
VANCOUVER - A national union is pushing provinces to adopt safer needles to reduce the injuries from needle-sticks, the generic term for all kinds of sharp medical tools.
Research done by the Service Employees International Union shows that 70,000 Canadian workers get cut or stuck by a needle-stick every year, said Mike McDonald, president of the SEIU local in Burnaby, B.C.
In the worst case, a hospital worker could contract a fatal disease from a used needle-stick. "We've lost one member in Saskatchewan," and others are living in uncertainty, not knowing if they may be infected with a disease like AIDS or hepatitis, he told CBC News Online.
But many of those injuries can be prevented by using needles with built-in safety mechanisms, research from the University of Virginia shows.
The university's International Health Care Worker Safety Center concluded that 60 to 70 per cent of needle-stick injuries can be prevented, B.C.'s Fraser Health said when it adopted a safer sharp policy last year.
"Cost analyses are beginning to indicate that, in the long term, the use of needle-stick prevention devices will be cost-effective, and even more importantly, will save health-care workers the emotional and physical toll associated with needle-stick injuries," David Lawson, Fraser Health's director of materiel management, said in a media release.
Fraser Health, a regional health authority, serves almost 1.5 million people in the Fraser Valley.
But it's one of the few places in Canada that has a policy on safe needle-sticks. The Manitoba government promised one in its throne speech in November, and Saskatchewan said last October that it would make safer needles mandatory.
FROM OCT. 29, 2004: Safer needles for Sask.
Now SEIU is pushing B.C. and other provinces to adopt safety needles.
Switching to the needles could cost B.C. $3.6 million a year, but reduced testing and treatment would save the province more than $8 million a year, McDonald said.
There are 6,800 injuries to B.C. acute-care workers every year, but conventional needles are also a threat to the public at large, he said.
"How many times have you seen needles lying around when walking in parks or playgrounds?"
http://www.cbc.ca/story/science/national
/2005/02/07/safer-needles050207.html
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February 8th, 2005
GlaxoSmithKline: Hepatitis B Vaccine Fendrix Gets EU OK
SourceURL:http://money.iwon.com
Edited Press Release
LONDON -(Dow Jones)- GlaxoSmithKline announced Tuesday it has received European approval for marketing its hepatitis B vaccine, Fendrix, formulated with a novel GSK proprietary adjuvant system, AS04.
Thanks to the combination of GSK Biologicals hepatitis B antigen and the novel adjuvant AS04 developed by GSK, Fendrix prevents hepatitis B in patients with renal insufficiency including specific high-risk groups such as pre- haemodialysis and haemodialysis patients, from 15 years of age onwards.
Haemodialysis patients' immune response is typically lower than in healthy individuals, therefore a need exists in such a vaccine with an improved immunogenicity profile to ensure that they are protected against hepatitis B infections.
Fendrix contains the GSK Bio Hepatitis B antigen and a novel proprietary GSK Bio adjuvant system, AS04 which includes MPL® from Corixa, that had been developed to have a higher potency than other available hepatitis vaccines, resulting in higher, more rapid and longer-lasting seroprotection.
Fendrix has a good safety profile, clinically acceptable local reactions similar to other licensed hepatitis B vaccines.
Adjuvants are formulated compounds that combined with vaccine antigens help to either direct or boost the body's immune system. GSK Bio has for some years led the scientific and vaccine field in this area of research. It focussed on the development of a portfolio of novel and proprietary adjuvant systems capable of either directing the most appropriate immune response or increasing the immune response in order to increase the effectiveness of a vaccine to prevent a particular disease.
The novel adjuvant AS04 is a component of a highly promising HPV vaccine against cervical cancer, that recently showed 100% efficacy against persistent infection with HPV types 16 and 18 . MPL® which is contained in AS04 is a component of GSK Bio's malaria vaccine, which also recently reported breakthrough results in clinical trials in the field . It is also a component of GSK Bio's genital herpes vaccine, which showed excellent efficacy against genital herpes in women in a phase III trial published in 2002 . Other adjuvanted vaccines in GSK Bio's pipeline include a vaccine for the prevention of cervical cancer and a vaccine in Phase I clinical trials against tuberculosis.
Dow Jones Newswires
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Many Hepatitis C Lawsuits Settled SourceURL:http://www.omaha.com
BY NICHOLE AKSAMIT
WORLD-HERALD STAFF WRITER
FREMONT, Neb. - Though settlement details remain private, court records and some involved confirm that more than half the malpractice lawsuits filed against Dr. Tahir Javed and his former Fremont cancer clinic have been settled out of court.
In 2002 and 2003, state health officials linked the reuse of syringes and other unsanitary practices at Javed's clinic to 99 hepatitis C infections.
The clinic closed after Javed returned to his native Pakistan. The state later revoked his medical license and that of his head nurse, Linda Prochaska.
As the first case approaches trial in Dodge County District Court, settlements continue to trickle in.
District Court Clerk Linda Nelson estimated Monday that only 45 cases remained unresolved out of the 93 filed against Javed; the Fremont Cancer Center and some of its nurses; and the Fremont Area Medical Center, the county-owned hospital that leased the clinic its space.
Earl "Chip" Greene estimated the number remaining at 40. Greene is an attorney for the Nebraska Excess Liability Fund. The fund pays damages, up to a cap set by the Legislature, to patients when settlements or court awards exceed malpractice insurance limits.
L. Tim Wagner, director of the Nebraska Insurance Department, which oversees the fund, said 54 cases had been settled, leaving 39.
He declined to disclose settlement amounts, individually or in total, saying that might jeopardize future cases and violate settlement agreements.
Wagner previously had worried that the sheer number of hepatitis C claims would bankrupt the fund and prompt unprecedented special assessments for the health professionals and facilities that now pay into it.
But so far, he said, it's looking like the fund will break even - with about $58.3 million in assets, $63 million in anticipated liabilities, and interest earnings to cover the gap.
Among the more recent cases settled are two that had been set to go to trial this year - those filed by Eleanor Daehnke and the husband of the late Cheryl Gentry.
Jeffrey Welch, attorney for the two and 23 others who settled in December, said he didn't think the settlements would affect the cases that advance to trial.
Nelson said jury selection is to begin in Fremont next week in the first of the cases to go to trial, that of Scot Schlecht.
Attorneys for Schlecht, Javed and the Fremont Area Medical Center did not return phone calls for comment.
According to court documents, Schlecht received chemotherapy at the clinic for brain cancer and later tested positive for hepatitis C.
The jury trial will be held in the federal courthouse in Omaha because of limited space at the Dodge County Courthouse.
It remains unclear which other cases will be up next. But Judge John Samson previously indicated that at least three would go to trial this year.
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Clinic to Offer Heroin, Despite US Needling SourceURL:http://news.yahoo.com
Canada - AFP
VANCOUVER (AFP) - Despite harsh US protests, a government clinic will doll out free heroin to hard-core addicts after it opens on Wednesday, a stone's throw from the US border.
The clinic in Vancouver will test, for the first in North America, whether prescribing heroin can cut overdoses, HIV (news - web sites) and hepatitis infections, and reduce hard-core junkies' dependence on crime to obtain the drug.
Several European countries have run similar studies, but the clinic's proximity, 37 kilometres (23 miles) to the United States, has made Canada's trial especially controversial.
Officials at the US White House anti-drug office have called it unethical and an "inhumane medical experiment."
Others, however, hope the clinic will help desperate addicts free themselves from lives of crime.
"Getting heroin prescribed as a trial is a huge victory," said Ann Livingston, director of an activist organization of drug users in Vancouver.
"My surprise is that we got this through after (US authorities) clearly didn't want it."
"It's a great idea," said Dianne Tobin, an addict for 30 years who supports a 300 dollar a day heroin habit with prostitution, shoplifting and trafficking drugs.
Tobin, 54, hopes to be one of the 158 addicts chosen to participate in the North American Opiate Medications Initiatives, or NAOMI, trial.
The trial is aimed at hard-core addicts aged at least 25, who have used heroin for at least five years. Participants must have tried, and failed, to break their habit using methadone at least twice.
A secondary goal of the study is to find out if it helps addicts wean themselves off heroin.
Lead researcher Dr. Martin Schechter, an HIV/AIDS scientist at the University of British Columbia, said 88 participants will receive pharmaceutical-grade heroin three times every day. The other 70 will take oral methadone. All will receive medical care and counselling.
Similar trials since the mid-1990s in Europe have worked, and a program has continued in Switzerland and the Netherlands. Germany and Spain are now running trials, and another is planned in Britain, said Schechter.
Squalid Downtown Eastside Vancouver is home to nearly 5,000 heroin addicts. Its clinc is one of three planned in Canada. Clinics in Montreal and Toronto are expected to open within the year. Mostly because of US politics, the scientific team abandoned its earlier plan to open three US clinics.
The trial has been approved by Canadian ethics committees and is receiving 8.1 million dollars in government funding.
Schechter, a leading HIV/AIDS researcher, said it would be unethical not to try to treat heroin addicts for whom other methods have failed.
"They are breaking into cars, being hospitalized, having overdoses, getting Hepatitis C and HIV, they're in the sex trade and they're in rough shape," he said.
Even as the trials begin, activists are lobbying for heroin prescriptions to continue if the one-year study proves helpful.
The researchers, however, said their job is to provide scientific evidence, and after the trial is over it will be up to politicians to decide how to use it.
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Antiviral Treatment Seems Effective in Some Hepatitis C-Associated NHL SourceURL:http://www.cancerpage.com
NEW YORK FEB 08, 2005 (Reuters Health) - The largest series to date evaluating antiviral treatment in patients with hepatitis C-related low-grade B-cell non-Hodgkin's lymphoma (NHL) shows it can be helpful in some cases. Anti-HCV treatment produced a complete response in 7 of 12 such patients, and hematological response was closely tied to reduction or clearing of viral load.
HCV has been linked to hepatocellular carcinoma and B-cell NHL, Dr. Daniele Vallisa of G. da Saliceto Hospital in Placenza, Italy, and colleagues note, but it is not clear how the virus might contribute to the disease. Antiviral treatment has shown success in treating cryoglobulinemia and splenic lymphoma, while interferon has shown antitumor effects in lymphoma not associated with HCV infection.
In the current study, the researchers tested a regimen of pegylated interferon and ribavirin in 13 patients with low-grade B-NHL and HCV infection. All had an indolent course of disease, meaning they had no bulky disease and tumor doubling time was a year or longer. Patients were evaluated at six and twelve months.
Patients weighing under 60 kg were given 50 micrograms of pegylated interferon alfa 2-beta subcutaneously once weekly, and took 1,000 mg of ribavirin once daily; heavier patients were given 70 micrograms of interferon and 1,200 mg of ribavirin.
At six months treatment was stopped if complete hematologic response with viral clearance had occurred or if there was no response. If there was partial response, treatment was continued for an additional six months.
Two of the patients had serious adverse effects and had to halt treatment. Treatment could be evaluated in 12 patients. Seven had a complete response, two had a partial response, two had stable disease and one showed progressive disease.
The researchers conclude: "The indolent course of a low-grade B-cell lymphoma in the setting of HCV infection should be an indication for initiation of antiviral treatment, both in genotype 1 and 2, and systemic viremia evaluation may be seen as a predictor of clinical response."
SOURCE: Journal of Clinical Oncology 2005;23:468-473.
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InterMune's Hepatitis Strategy Gets the Right Response
SourceURL:http://www.pharmaceutical-business-review.com
8 Feb 2005, 18:27 GMT - A significant rise in sales of InterMune's hepatitis drug Infergen, from $9.3 million in 2003 to $22.3 million in 2004, is the result of the company's focus on marketing Infergen to HCV non-responders. In targeting this vital patient sub-group, InterMune could gain a useful head start in an area of hepatitis treatment that is set to become fiercely competitive in the years ahead.
Infection with the hepatitis C virus (HCV) is four times more common than HIV infection, and chronic HCV infection (CHC) is associated with considerable morbidity and mortality due to CHC-associated liver cirrhosis and cancer. Between 170-200 million individuals are estimated to be infected worldwide, with a prevalence of approximately 7.5 million in the seven major markets and 2.7 million in the US alone, according to Datamonitor research.
InterMune is a small biopharmaceutical company, primarily focused on pulmonology and hepatology. Although the bulk of InterMune's revenues are derived from Actimmune sales (80% in 2004), the company is shifting its focus to CHC infection. In the past, InterMune's second core product, Infergen, has not gained significant market share for first-line HCV therapy, being prescribed to less than 5% of all CHC patients as first line across the seven major markets according to recent Datamonitor research.
However, given the limited chance of success through retreatment with the current standard of care, pegylated-IFN (peg-IFN) alfa plus ribavirin (RBV) following treatment failure, physicians are now turning to alternative therapies in the hope that these might benefit their non-responder patients. Datamonitor research revealed that IFNs other than unmodified or peg-IFN alfa, are used as monotherapy for second-line therapy in 2.5% of patients and as combination therapy with RBV in up to 17%.
In the absence of an approved second-line therapy and with the limited efficacy of retreatment with peg-IFN and RBV combination therapy, the CHC non-responder pool is becoming an increasingly important target population. Indeed, in the US for example, this sub-group of patients is estimated at 150,000, increasing by up to 50,000 patients per year.
In addition, the asymptomatic nature of CHC and the long period of viral persistence required for health-threatening disease symptoms to become apparent means there is an anticipated peak of CHC patients requiring antiviral treatment between 2010 and 2020. Consequently, while the CDC reports a sharp decrease of new HCV infections in the past two decades, both big pharma and small biotechs have actively been developing new drugs and strategies to compete for their share in this highly competitive market.
InterMune has been quick to seize on this opportunity, investing in a new Infergen sales force of 31 representatives together with expanded marketing and medical information support. These positive steps are likely to continue in the short term, concomitant with clinical support for the efficacy of Infergen in the key non-responder patient group emerging from InterMune's DIRECT trial. This is a Phase III clinical trial evaluating the use of Infergen in combination with RBV in non-responders to previous peg-IFN-based therapy.
InterMune's strategy is not that unusual, with industry interest in this indication expanding rapidly, as highlighted by the relatively strong HCV pipeline across the pharma sector. Yet InterMune's established HCV market presence should work to its advantage in expanding its indication to a steadily growing patient sub-group that represents a major medical unmet need. Whether this strategy will work out in the long term depends on how successful new HCV drugs will be in treating non-responders. Heavy investment in a strong sales force might prove critical to secure market share before other drugs in the immunomodulator class reach the market.
Source: Datamonitor Expert View
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February 9th, 2005
Doctors Issue Hepatitis B Warning SourceURL:http://www.thisislondon.co.uk/
By Rebecca Smith
Health Correspondent, Evening Standard
Doctors today called for all children to be vaccinated against a potentially fatal liver disease as the number of cases soars.
Unlike many other European countries, the UK does not routinely immunise against hepatitis B which can lead to cirrhosis of the liver, cancer and death.
The World Health Organisation recommended that by 1997 all children should have the jab, even in countries where the number of cases is low. But Government policy is to vaccinate only those "at risk".
Doctors say this is not effective. One laboratory in east London has seen about 302 cases in the last two years, but experts believe there are thousands more who have the disease and don't know it.
Professor Graham Foster, consultant hepatologist at Bart's and the London NHS Trust, said he is seeing large numbers of people with hepatitis B.
The highly infectious virus is passed through bodily fluids including saliva and blood. It can be transmitted easily from mother to baby, among young children playing together, in blood transfusions and through sexual contact.
Adults who catch hepatitis B mostly develop acute disease which tinges the skin yellow. A proportion die quickly. Young children mostly develop the chronic form which goes undetected, but can rot the liver and cause cancer.
Professor Foster said between five and 10 people are diagnosed each week at his clinic. "I am seeing dramatically more people with it than I used to. My colleagues throughout London have told me they are also seeing a lot more."
He said treating people with the disease is expensive and not very effective, so it is "madness" not to vaccinate against it.
It is thought the spread in London is fuelled by tourists to countries with high infection rates, and through ethnic communities. "Young people are dying and it is potentially preventable," said Professor
Foster. "The vast majority of physicians in this area are for routine vaccination."
Dr Sam Everington, deputy chairman of the British Medical Association, said other European countries with similar rates to Britain's are vaccinating children. He added: "There are 350 million carriers worldwide. We should be vaccinating now."
A Department of Health spokesman said: "The UK has one of the lowest prevalences in the world. Expert advice has been we should improve immunisation of groups most at risk of infection, such as babies born to mothers with hepatitis B, injecting drug users and gay and bisexual men, and this is what we have been doing.
"The Joint Committee on Vaccination and Immunisation, is considering whether the programme might need to be strengthened or expanded in future."
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India's Vaccines Come with Risk: Dirty Needles Used for Immunization Can Spread Other Diseases SourceURL:http://www.washingtonpost.com
By Rama Lakshmi
Special to The Washington Post
GUDAMB, India -- As soon as a rural health worker, Jayalakshmi Nair, walked into this village on a recent visit, she began encouraging women to bring their children to receive immunizations against such life-threatening diseases as tuberculosis and leprosy.
But as she set up a makeshift office with a table and chair in the courtyard of an elementary school, she knew that she could be spreading other illnesses.
By the time the mothers reluctantly lined up with wailing children in their arms, Nair had begun using a pot of water that had been heated over a wood fire to clean her reusable syringe. For two hours, Nair dipped used needles in the lukewarm water for a few seconds with her bare hands before re-using them.
"There is no power in the village most of the day. For sterilization we are supposed to carry kerosene and cooking stove with us to the villages," Nair said, capping the needles before she prepared to use them again.
"But for six months there has been no kerosene supply. So I have to make do with whatever I have," she said, acknowledging the risks associated with unsterilized equipment. "For me, immunizing the children is a bigger priority."
For shots against tuberculosis and leprosy, she used the same needle and glass syringe for each child, pausing between patients by briefly dipping the needle in the steel pot. For diphtheria shots, she changed the needle but used the same glass syringe for each injection without any attempt to sterilize the equipment.
Government-run immunization sites such as Nair's in the northern Indian state of Uttar Pradesh are a major danger zone for the spread of blood-borne infections such as Hepatitis B, Hepatitis C and HIV, according to a study funded by the World Bank last year. Nair is a government nurse in the state's Saharanpur district, where only 38 percent of the population has received immunizations, officials said. They have reported outbreaks of measles in the region almost yearly.
Officials said they expected a significant change with the decision to begin introducing auto-disable syringes in all of their immunization programs, starting this year.
The AD syringes, as they are known, are single-use injection devices that work by locking the plunger of the syringe after a dosage has been administered, making re-use impossible.
About 250 million to 300 million immunization injections are given in India every year and the switch from glass to AD syringes is being made despite a significant cost increase in India's immunization program, officials said.
"Protecting children by the right immunization device is central to increasing child survival rates in India," said Marzio Babille of UNICEF, which has used AD syringes in trial programs in India. "Introduction of AD syringes boosted demand for immunization by 20 percent in the villages we work in, because parents see that the shots are painless and safe," Babille said.
According to the World Bank-funded study conducted by a nongovernmental consortium, the Indian Clinical Epidemiology Network, or IndiaCLEN, about 65 percent of all injections in India are unsafe due to improper sterilization, syringe re-use or incorrect injection practices. And 69 percent of injections administered in government-run facilities were found to be unsafe.
Beset with the problems of irregular and inadequate supply of equipment, India's race to increase immunization coverage has often meant taking shortcuts on safety procedures.
"India has one of the largest immunization programs in the world," with tens of thousands of sites, many of which use glass syringes, said Pradeep Haldar, a Health Ministry official. "Monitoring each site is impossible. Injection safety has been compromised because sterilization is a cumbersome, time-consuming process."
The World Health Organization estimates that at least 50 percent of the world's 16 billion injections administered each year are unsafe, posing serious health risks.
"Irrational injections and wrong injection practices are rampant," said Narendra Arora, the team leader of the IndiaCLEN study. "Many give injections over the patient's shirt, touch the injection with their hands or wipe it with a swab." He said training programs against such practices would soon be introduced in medical colleges.
A recent study by a New Delhi-based environment group, Vatavaran, found that about 40,000 plastic syringes were used daily in the capital's hospitals, but only 40 percent were disinfected and destroyed after use. The remainder were picked up from dumping sites, washed, repacked and resold, the report said.
The case of Khursheed Mustaqeem demonstrates the dangers of improper needle use. Mustaqeem, 26, said that her son, Faizan, 5, was diagnosed with HIV two years ago, even though she and her husband tested negative for the virus, which causes AIDS.
"I was shocked when the doctor told me Faizan got it through unsafe needles," she said, patting Faizan to sleep in her tiny one-room home in New Delhi.
Her son has been receiving antiretroviral drugs for a year.
"My son cannot play marbles on the street like other boys. He just watches them from the window," she sighed. "Now I dread all hospitals and all needles. God knows what dangerous disease I will bring back home."
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MCAVN Fund-Raiser Turns 18 SourceURL:http://www.ukiahdailyjournal.com
This year's event hopes to raise $30,000 for local AIDS, Hepatitis C services
"And the beat goes on..."
That's the theme this year of the annual Event of the Heart dinner-dance to raise money for the Mendocino County AIDS Volunteer Network.
Begun 18 years ago, the event has continued despite hopes early on that the network itself was addressing a crisis, not a couple of decades of work with a disease that has continued to devastate the planet.
MCAVN meets a wide range of needs for both AIDS patients in the county as well as patients with Hepatitis C, a growing problem in the county.
MCAVN carries out the needle exchange program authorized by the county and in 2003-04 alone, the organization handed out 75,000 clean needles to people who might otherwise be sharing hypodermic needles and spreading disease further.
The Event of the Heart is important because it raises funds for MCAVN that can be used without restrictions. The needle exchange program is one of those programs.
MCAVN also gets grants and donations to continue its HIV prevention education, HIV testing, jail outreach, benefits counseling for AIDS patients, Hepatitis C support groups, a drop-in center in Ukiah and a food pantry in cooperation with the Ukiah Food Bank.
The group also helps AIDS patients with housing assistance, utilities assistance, transportation and nutrition assistance, support groups and social work case management.
MCAVN director Cyril Colonius explains that MCAVN is looking at almost 20 years of working with AIDS patients in Mendocino County and has come to the conclusion that "we're here to stay." The organization has in recent years also taken on helping the increasing numbers of Hepatitis C patients in the county.
Some 182 people are living with HIV in the Mendocino County today and thousands are infected with Hepatitis C, which Colonius says is another critical problem.
Hepatitis C hits the body's liver. It is a chronic disease that can linger for a long time, slowly increasing as the patient gets more and more debilitated. Many of those afflicted with the disease do not get the care they should have until they need significant help with day-to-day living.
"At first, Hepatitis C may not be their number one priority, it may be food or shelter. Good medical care tends to be on the lower level of things," he said.
Event organizers hope that The Event of the Heart this year will raise $30,000.
The evening begins at 6:30 p.m. with a sparkling wine reception, followed by dinner at 7 p.m. and dancing at 9:30 p.m. with Charlie and the Nightcats. A raffle for a week's vacation in Hawaii is also part of the fun.
Dinner tickets at $65 per person are going fast, but the public can also attend the dance only for $15 per person or $20 at the door. The Event of the Heart is held at Carl Purdy Hall at the Redwood Empire Fairgrounds in Ukiah.
For more information, call MCAVN at 462-1974.
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February 10th, 2005
MIGENIX Inc. (MGI.TO) Releases CEO Message; Provides Update on Major Clinical Programs SourceURL:http://www.biospace.com
VANCOUVER, BC, and SAN DIEGO, CA, Feb. 9 /PRNewswire-FirstCall/ -- MIGENIX Inc. (TSX: MGI; OTC: MGIFF), a developer of drugs for infectious and degenerative diseases, has issued its 14th Quarterly CEO Message from Jim DeMesa, MD, President & CEO. Today's CEO Message provided updates on the Company's lead clinical programs, specifically:
MX-3253, in development for the treatment of chronic Hepatitis C virus infections, will have data from two clinical trials in calendar year 2005: - Phase II monotherapy results anticipated late second quarter or early third quarter - Phase II combination study to be initiated mid year with data around year-end - MX-4509, in development for the treatment of Alzheimer's disease and other neurodegenerative indications, will complete two clinical trials in calendar year 2005: - Phase I/II study in Alzheimer's patients looking at biomarkers as an indication of activity to be initiated mid year with results anticipated in the fourth quarter - Phase I safety, pharmacokinetic, dose-escalating study in healthy volunteers to be initiated mid year with results expected in the third quarter - MX-226, a product candidate in development for the prevention of catheter-related infections will initiate a pivotal Phase III confirmatory study in 2005. License partner, Cadence Pharmaceuticals, is in the process of obtaining a Special Protocol Assessment from the FDA to begin the Phase III trial mid-year.
To obtain a copy of the complete CEO Message, please visit the MIGENIX web site at http://www.migenix.com/ or contact Investor Relations at 1-800-665-1968, Extension 241.
About MIGENIX
MIGENIX is committed to advancing therapy, improving health, and enriching life by developing and commercializing drugs in the areas of infectious and degenerative diseases. With multiple product opportunities in various stages of clinical and preclinical development, the Company's most advanced clinical programs include drug candidates for the treatment of chronic Hepatitis C infections, the prevention of catheter-related infections, the treatment of Alzheimer's disease and other neurodegenerative diseases, and the treatment of acne. MIGENIX is headquartered in Vancouver, British Columbia, Canada with US operations in San Diego, California. Additional information can be found at http://www.migenix.com/.
CONTACTS Jonathan Burke MIGENIX Inc. Tel: (604) 221-9666 Extension 241 jburke@migenix.com Gino de Jesus or Dian Griesel, Ph.D. The Investor Relations Group Tel: (212) 825-3210 Theproteam@aol.com Renmark Financial Communications John Boidman: jboidman@renmarkfinancial.com Edith English: eenglish@renmarkfinancial.com Media: Cynthia Lane: clane@renmarkfinancial.com Tel: (514) 939-3989 The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.
Certain statements in this CEO Message constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause our actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements in this release include, but are not limited to: results from the MX-3253 Phase II HCV monotherapy trial either late in the second quarter or early in the third quarter of 2005; initiating a MX-3253 Phase II HCV combination study by mid 2005 and having data by the end of 2005; initiating two clinical studies for MX-4509 by mid 2005 and having results by the end of 2005; and Cadence Pharmaceuticals obtaining a Special Protocol Assessment from the FDA for MX-226 and beginning a pivotal Phase III trial by mid 2005. These statements are only predictions and actual events or results may differ materially. Factors that could cause such actual events or results expressed or implied by such forward-looking statements to differ materially from any future results expressed or implied by such statements include, but are not limited to: future capital needs; uncertainty of additional funding; technology and product development; early stage of development; government regulation; no assurance of market acceptance; dependence on and management of current and future corporate collaborations; dependence on proprietary technology and uncertainty of patent protection; intense competition; manufacturing and market uncertainties. These and other factors are described in detail in the Company's Annual Information Form and Annual Report on Form 20-F, forthcoming news releases and other filings with the Canadian securities regulatory authorities and the U.S. Securities & Exchange Commission. Forward-looking statements are based on our current expectations and MIGENIX is not obligated to update such information to reflect later events or developments.
MIGENIX Inc.
CONTACT: Jonathan Burke, MIGENIX Inc., Tel: (604) 221-9666 Extension241, jburke@migenix.com; Gino de Jesus or Dian Griesel, Ph.D., The InvestorRelations Group, Tel: (212) 825-3210, Theproteam@aol.com; Renmark FinancialCommunications: John Boidman: jboidman@renmarkfinancial.com; Edith English:eenglish@renmarkfinancial.com; Media: Cynthia Lane:clane@renmarkfinancial.com, Tel: (514) 939-3989;To request a free copy of this organization's annual report, please go to http://www.newswire.ca/ and click on reports@cnw.
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Vancouver Clinic to Offer Heroin on Prescription SourceURL:http://www.reutershealth.com
By Allan Dowd
VANCOUVER, British Columbia (Reuters) - Vancouver adds prescription heroin for hard-core addicts to its arsenal in the war against drugs this week, despite U.S. criticism that its trial is a sign of Canadian weakness in the battle against illegal drugs.
Medical researchers with the new clinic, North America's first trial of prescription heroin, say their motives are not political. They hope to test if prescribing heroin can help addicts who have not been able to kick their habits through traditional programs like methadone treatment or abstinence.
The clinic starts taking applicants from drug addicts wanting to join the program on Thursday.
Vancouver, on Canada's Pacific coast, is already the focus of a debate over drug treatment policy as the site of North America's first government-sanctioned injection site for drug addicts, which opened in 2003.
The city includes the Downtown Eastside area, one of the poorest and drug-infested neighborhoods in Canada.
Dr. Martin Schechter, lead researcher for the North American Opiate Medication Initiative, said the new government-funded study is not designed to promote the legalization of heroin. The study is expected to last 21 and 24 months.
"We're not an advocacy group. We're researchers looking at a medical and scientific question," Schechter said.
"If and when politicians and other decision makers have to look at the question of offering medically prescribed heroin, we'd like them to make that based on evidence not based on emotion."
Schechter said heroin studies have already been conducted in Europe so this study could only be considered "radical" as the first in North America. The group will also open heroin clinics in Toronto and Montreal.
Officials in the White House's Office of Drug Policy have dismissed the Canadian experiment as an example of what governments should not do to treat heroin addiction, and they advocate sticking with methadone treatment, where addicts are prescribed methadone as a substitute for heroin.
The study has the guarded backing of police officials in Vancouver, who hope for a reduction in the crime and health problems associated with injection drug use.
The researchers hope to enroll about 157 participants in Vancouver and 470 nationally.
Addicts will administer the drugs themselves under medical supervision, with half receiving pharmaceutical-grade heroin and half in a control group using methadone, a medicine that blocks heroin craving and prevents withdrawal symptoms.
The group receiving heroin will eventually be moved into the methadone treatment, and researchers will study which treatment method addicts are willing to stick with as well as their physical and mental health during the study.
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Insurance Help for Transfusion Victims Planned Ireland Online
The Government is to fund a special scheme to help people infected with Hepatitis C and HIV through the state's blood transfusion service to obtain mortgages and insurance, it emerged tonight.
Minister for Health Mary Harney said the Cabinet had agreed to her proposal to establish a mechanism to address insurance difficulties experienced by those infected through contaminated blood and blood products.
"I am pleased to announce the establishment of this scheme which will provide reasonable access to the insurance market for those for whom the cost is prohibitive or cover is unavailable," she said.
Under the scheme, anyone seeking insurance will now pay the average basic premium, which an uninfected person of the same age/gender would pay, with the State paying the additional risk premium or assuming cover on the life where the assuror deems the person uninsurable.
Ms Harney said the scheme will cover all standard life assurance policies offered by life assurors who are authorised to trade in Ireland and who opt to participate in the scheme.
A scheme to cover travel insurance loadings will also be devised, she added.
The main components of the scheme are:
Life assurance to age 75, with a maximum life assurance cover of €400,000 or seven times the earned income of the eligible participant or his/her partner up to a maximum of €500,000. These sums will be indexed in accordance with the Consumer Price Index.
Mortgage protection cover up to age 75 on purchasing or changing the primary residence, up to a maximum of the average house price in Dublin plus 25% or €375,000, indexed in accordance with TSB/ESRI (Dublin) House Price Inflation.
For an initial period of 12 months (or, if later, three years from the date Hepatitis C/HIV is diagnosed) all persons with Hepatitis C/HIV will be entitled to apply for cover under the scheme. Thereafter, a waiting period to apply, during which full cover would be phased in over two years for the under-50s and three years for over-50s).
There will be an open period for young people who are not able to avail of insurance/mortgage protection at this time, until the date of their 30th birthday.
The Tánaiste thanked Dr Elizabeth Kenny, chairman of the Consultative Council on Hepatitis C, and the executive members of Positive Action, Transfusion Positive, the Irish Haemophilia Society and the Irish Kidney Association for their co-operation and assistance in devising the scheme.
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Chua: Cuban Medical Success Can Be Emulated News
The Star Online
http://thestar.com and http://groups.yahoo.com/group/hepcan/
KUALA LUMPUR: Cuba's successful battle against the dengue epidemic and infectious Hepatitis C disease needs to be studied and, if possible, emulated in Malaysia.
Health Minister Datuk Dr Chua Soi Lek said that during a recent visit to Cuba he had learned that the country's methods were very effective in combating the two diseases.
"I will inform the Government about Cuba's ability to combat dengue and Hepatitis C disease so that we can observe how they did it," he told reporters at the MCA Chinese New Year open house here on Wednesday.
Even Singapore, with its strict laws on cleanliness, could not protect itself from the dengue epidemic, he said, adding that 120 countries around the world were grappling with dengue.
Chua also said that the number of Malaysians having Hepatitis C was on the rise.
Below is a vaccine project they are working on;
http://gndp.cigb.edu.cu/Profiles/
04%20CIGB%20Hepetitis%20c%20virus.htm
Centro de Ingenieria Genetica y Biotecnologia
BUSINESS DEVELOPMENT GROUP
Hepatitis C virus
Development of therapeutic vaccine against Hepatitis C virus
Therapeutic area: Infectious diseases
GOAL
The development of a vaccine formulation to generate a therapeutic response and a wide range of protective immunity against the Hepatitis C virus
DESCRIPTION
According to recent WHO statistics, there are 170 millions people infected with hepatitis C virus. HCV infection is chronic in more than 80% of infected persons. There is no currently available prophylactic vaccine against this pathogen and most studies are in pre-clinical phase. Antiviral treatments in use are aggressive, expensive and generally effective in less than 50 % of cases.
At CIGB, the structural region of the major circulating genotype 1b strain of HCV in Cuba has been cloned and it is the base of the vaccine candidates under investigation. Variants of HCV core, E1 and E2 proteins have been obtained from recombinant microorganisms. Immunogenicity studies with formulations based on these recombinant proteins is currently under research in different animal models. The strong humoral and cellular immune responses elicited in mice with these formulations support the near evaluation of this approach in non-human primates.
The most advance approach is a DNA vaccine formulation based in a construct comprising the genes for the three main structural antigens of the virus plus the HCV core protein, as an immunopotentiator molecule. This DNA vaccine formulation induces broad, strong and sustained humoral and cellular immune responses, in different animal models, including protection in mice against the challenge with a recombinant vaccinia virus expressing the core, E1 and E2 genes. Last year, we have advanced in product development up to production of lots for stability and pre-clinical evaluation. Additionally, bio-distribution results obtained so far are really promising with respect to functionality and safety . These encouraging elements confirmed the feasibility to evaluate the DNA vaccine formulation in humans with prophylactic and/or therapeutic purposes.
PATENT STATUS
Patent filed in PCT.
PROJECT STATUS
Development and Preclinical.
TYPE OF COLLABORATION REQUESTED
Corporate partnership for joint development
COMPETITIVE ADVANTAGES MILESTONES (2004)
Experience in vaccine research and highly skilled staff and self-reliant laboratories.
After a Phase I clinical trial in health volunteers in the second semester of 2004, a therapeutic clinical trial phase I/II in patients with the new vaccine formulations should be conducted by the end of year 2005. Two years more should be required for the conclusion of the phase III. The vaccine could be ready for registration by year 2007.
HOST INSTITUTION
Center for Genetic Engineering and Biotechnology (CIGB). Ave 31, e/158 y 190 Cubanacán, Playa. PO Box 6996, Havana, 10600, Cuba. Tel. (53-7) 2712397; 2716022. Fax. (53-7) 336008; 2718070.
Email: ernesto.lopez@cigb.edu.cu . Web site: http://gndp.cigb.edu.cu
Project code: BIO/CIGB/2004-04
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February 11th, 2005
Hepatitis C, a Silent but Deadly Killer SourceURL:http://www.orovillemr.com
By Mary Weston/Staff Writer
Approximately 3.9 million persons in the U.S. are infected with Hepatitis C virus, and 2.7 million will go on to have persistent infection. Up to 8,000 people in Butte County California could have the virus.
It is the most common chronic blood borne infection in the U.S., but most people don't know they have it in their system. Hep C is a virus carried in the blood that causes liver inflammation and can lead to cirrhosis, liver cancer and death.
The good news is there's an effective treatment. The bad news is about 75 to 85 percent of newly infected people don't exhibit symptoms in the acute phase, so most of them don't seek treatment.
Dr. Abdullah Al-Dwairi, of the Oroville Family Health Center, internal medicine and infectious diseases, said the Del Norte clinics screen patients through confidential questionnaires and recommend testing for those at high risk for contacting the virus.
"People at risk should be tested," Al-Dwairi said.
The highest transmission rate comes via infected needles with IV drug use, but other activities that can involve sharing blood also carry a risk of infection.
About 15 percent of patients who acquire an acute Hepatitis C infection will clear the virus from their blood within six months, but for some it may take 24 months. Those who clear the virus will no longer have it in their system. Others will continue to carry infection.
"About 85 percent of infected patients will continue to have persistent infection for life if not treated," Al-Dwairi said.
This 85 percent that go on to carry chronic infection might not have symptoms for the next 20 years or in their lifetime, or the disease can progress infecting the liver and causing cirrhosis or liver cancer.
Hepatitis C progresses slowly. The first acute symptoms could be fatigue, fever, nausea, abdominal pain, jaundice and dark urine, Al-Dwairi said. These symptoms usually resolve over weeks before the patient goes into a chronic phase.
During the chronic phase, general fatigue may be the only symptom. If the disease progresses affecting the liver, the patient might come back 20 years later with manifestations of late liver disease, he said.
Those symptoms might include jaundice, yellowing of the skin and eyes, and they can have fluid retention and distention of the abdomen.
Liver cancer and cirrhosis can be detected with imaging technology and liver biopsy, although some cases of cancer can be missed on liver biopsy, he said. Screening for a tumor marker in the blood can help in detecting early liver cancer.
Other symptoms outside of liver involvement include kidney disease, skin lesions, arthritis, and inflammation that involves small blood vessels.
And as long as the virus is in the blood, it can be spread to others. Although not 100 percent effective, tests can detect antibodies to the virus in the blood.
However, recent treatments have effectively cleared the virus from the blood, with patients remaining Hepatitis free in 10-year follow-up tests.
Since 2001, a combination treatment of pegylated Interferon and Ribavirin has more effectively cleared the virus from the blood and liver in six to 12 months and in 12 to 18 months in patients also carrying HIV. Still, the side effects profile remains almost the same as with the old therapy with regular interferon.
Most patients will suffer side affects from the treatment ranging from flu-like symptoms to psychosis and depression. However, these symptoms usually subside after two to four weeks of starting therapy, and patients will be monitored and treated for side effects.
The treatment also carries the risk of birth defects, so pregnant women can't undergo therapy.
Jeannie Maes, a communicable disease nurse for the Butte County Department of Public Health, said statistics indicate between two and four percent of the population nationwide are infected with Hepatitis C.
Maes, who is also on the Butte County Hepatitis Task Force said to those estimates; up to 8,000 people in Butte County could be infected, many of whom do not know they have the disease, and all of whom would benefit from treatment. The disease is under reported in Butte County because people don't recognize symptoms.
However, Maes said the disease behaves differently in individuals, and some people don't need treatment, but up to 60 percent can be treated successfully. About three to five percent of patients will have such severe disease that they will eventually need a liver transplant, but most people affected have no disease or mild liver disease, Maes said.
Prevention includes not sharing needles and not sharing items contaminated by blood such as tooth brushes, body piercing items and nail clippers. Also get tattoos at professional parlors, don't share drug paraphernalia and use blood barriers such as condoms and gloves.
Dr. Mark Lundberg, Butte County Health Officer, chairs the task force. The focus of this collaborative project includes prevention, early detection, and treatment using best practices. By sharing information and resources, the task force seeks to better serve those infected with Hep C throughout the county.
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Herbal Remedy as Good as Drug for Depression: Study
SourceURL:http://www.reutershealth.com/
LONDON (Reuters) - An extract of the herbal remedy St. John's wort is as effective as a commonly prescribed drug for people with moderate-to-severe depression, researchers reported this week Friday.
They compared the extract called WS 5570, which is made by the German company Dr. Willmar Schwabe Pharmaceuticals, and the antidepressant paroxetine sold by GlaxoSmithKline Plc under the brand name Paxil or Seroxat.
St. John's wort is also known as hypericum perforatum.
"In the treatment of moderate to severe major depression, hypericum extract WS 5570 is at least as effective as paroxetine and is better tolerated," Professor Armin Szegedi of the Charite-Universitatsmedizin, part of the University of Berlin, said in a report published online by the British Medical Journal.
In a study funded by the German company, the researchers compared the treatments in 251 patients, between 18 and 70 years of age, for six weeks. Half of the patients taking the extract reported an improvement, compared with one third taking paroxetine.
Patients taking the extract also reported fewer side effects, such as stomach disorders, according to the researchers.
Paroxetine belongs to a class of drugs known as selective serotonin re-uptake inhibitors (SSRIs). British and European health authorities have voiced concern that these antidepressants may increase the risk of suicide in young people.
"Our results support the use of hypericum extract WS 5570 as an alternative to standard antidepressants in moderate-to-severe depression, especially as it is well tolerated," Szegedi added.
St. John's wort has been called nature's alternative to Prozac, but researchers have warned that it can interfere with hormone treatment, antibiotics and chemotherapy.
Earlier studies have shown the herbal remedy is also effective for treating patients with mild depression.
The researchers called for further studies to confirm their findings.
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Another Javed Suit Is Settled
SourceURL:http://www.omaha.com
BY NICHOLE AKSAMIT
WORLD-HERALD STAFF WRITER
Of dozens of civil lawsuits related to a hepatitis C outbreak in Fremont, Neb., Scot Schlecht's was to be the first to go to trial.
The Scribner, Neb., man allegedly contracted hepatitis C while receiving chemotherapy for brain cancer at Dr. Tahir Ali Javed's former Fremont clinic.
Jury selection was set for Wednesday; the Dodge County District Court trial was to begin Friday. Several witnesses already had been subpoenaed.
But a week before the trial's scheduled start date, it seems the case has been settled.
Reservations for a courtroom at the federal courthouse in Omaha were canceled Friday morning. Dodge County District Court Clerk Linda Nelson confirmed Friday afternoon that the Schlecht trial was off.
"The judge indicated to me that the attorneys had settled the case," Nelson said. "But there's nothing in writing yet."
Attorneys contacted said they either didn't know or couldn't comment about the settlement.
State health officials have linked 99 cases of hepatitis C to the reuse of syringes and other unsanitary practices at Javed's clinic.
To date, 122 lawsuits have been filed in relation to the outbreak. Some are duplicate filings by the same party. Consolidated, those against Javed total 92. Of those, court records show that at least 52 besides Schlecht's have been settled out of court.
Javed and his head nurse have lost their Nebraska medical licenses. No one else - including other medical staff named in some lawsuits or the Fremont Area Medical Center, which leased Javed space for his clinic - has been publicly deemed liable for the outbreak.
Friday's development, the latest in a flurry of settlements since early December, begs the question: Will any of the three dozen or so cases remaining make it to trial?
Four other cases have been identified as possible next-ups, but even those have been double-booked for trial dates in August and October.
Attorneys for the parties involved are under a gag order not to discuss ongoing negotiations or actual settlements.
Patrick Borchers, dean and professor of law at the Creighton University School of Law in Omaha, said it wouldn't surprise him if all the cases settled.
"Cases tend to settle when the attorneys' estimate of the value of the cases is close enough that there's no point in burning further resources pursuing it," he said.
For example, he said, if one attorney thinks the case is worth $100,000, another thinks it's worth $120,000, and it's going to cost more than $20,000 to litigate, the case likely will settle.
Borchers said it's also not unusual for cases to settle so close to the start of a trial - or even during it.
"Cases either tend to settle really early, when there's still a lot of cost way out there," he said. "Or they tend to settle quite late, when everyone knows pretty much everything there is to know about each other's case. My guess . . . is that probably neither side thinks that there's a whole lot of factual issues left."
Borchers said settlements can be good for the courts and the parties involved.
"It means the Dodge County District Court isn't going to be tied up in trial over these things," he said. "And both sides hopefully can have some closure."
He said few plaintiffs actually want to go to trial, but it's possible that some of the cases could proceed that far if plaintiffs feel strongly about having their day in court.
"People sometimes feel like they want to make their point," he said. "My guess is that they did. I'd be very surprised if there were ever a repeat of anything like this (outbreak) as long as any of the relative participants are still alive."
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