Back to News Review
Week Ending: July 15th , 2006
Alan Franciscus
Editor-in-Chief
To download pdf version click
here
This Issue:
Back to top
July 7th, 2006
Researchers Aim to Cut Future Need for Liver Transplants
http://www.sciencedaily.com
University of Edinburgh scientists have identified primitive liver cells –possibly dormant from the earliest developmental stage of a human being – which have the potential to mature into different cells types and help repair a failing liver. Their newly-published findings could pave the way for alternative treatments using cell replacements instead of organ transplants for those with liver failure.
A functioning liver is essential for human survival with liver failure ultimately resulting in death, and liver transplantation is presently the only treatment for acute and chronic liver failure. However, the supply of donor livers is insufficient to meet demand, and in the United Kingdom, 20% of patients waiting for a liver transplant will die from liver failure before a suitable donated organ becomes available.
Head of the group Dr James Ross said: "Potentially, cell replacement therapies could provide alternative treatments that would avoid difficulties associated with obtaining sufficient donor organ transplantation. We have now identified primitive cells with the potential to mature into different cell types within and out with the liver. It is possible that these cells lie dormant in the adult liver and may be the source of repair cells that are activated by severe liver injury."
"The liver is often able to repair and heal itself following injury or damage and this occurs in one of three ways. Firstly, mature liver cells have a well recognized and extensive capacity to divide in response to injury. Secondly, in response to massive loss of functioning liver tissue, a population of primitive liver stem cells may be stimulated to proliferate and develop into mature liver cells. The third mechanism of liver repair involves circulating stem cells originating from other sources, such as the bone marrow, and it is possible that these cells may be recruited into the liver and form new liver cells."
The research team is based in the Department of Surgery and in the Tissue Injury & Repair Group, Centre for Regenerative Medicine, at the University of Edinburgh.
The findings are published in the current edition of The American Journal of Physiology- Gastrointestinal and Liver Physiology.
Back to top
July 8th, 2006
Genes Don't Treat Gender the Same
http://seattlepi.nwsource.com
By LEE BOWMAN
SCRIPPS HOWARD NEWS SERVICE
New UCLA study raises idea of sex-specific drugs
Genetic differences between men and women hardly end at the X and Y chromosomes.
A new study by researchers at UCLA has determined that thousands of human genes behave differently in the corresponding organs of males and females -- even in fat and muscle tissue.
The findings help explain why the same disease often affects men and women differently, and why the effects of some drugs may vary drastically between the sexes.
"This research holds important implications for understanding disorders such as diabetes, heart disease and obesity, and identifies targets for gender-specific therapies," said Jake Lusis, a professor of human genetics at UCLA and a co-author of the report, published in the August issue of the journal Genome Research.
The researchers examined brain, liver, fat and muscle tissue from mice with the goal of finding genetic clues related to mental illness, diabetes, obesity and heart disease in humans. Humans and mice share 99 percent of their genes.
The scientists looked at gene expression -- the process by which a gene's DNA sequence is converted into proteins that carry out various functions inside cells. Working with Seattle-based scientific data management firm Rosetta Inpharmatrics, the team scrutinized more than 23,000 genes to measure their expression levels in male and female tissue.
While each gene basically functioned the same in both sexes, the scientists found a direct correlation between gender and the volume and pace by which proteins were expressed.
"We saw striking and measurable differences in more than half of the genes' expression patterns between males and females," said Dr. Thomas Drake, a professor of pathology at UCLA and a co-investigator. "We didn't expect that."
"At the genetic level, the only difference between men and women is the sex chromosomes," Drake said. "Out of the more than 30,000 genes that make up the human genome, the X and Y chromosomes account for less than 2 percent of the body's genes.
"But when we looked at the gene expression in these four tissues, more than half of the genes differed significantly between the sexes."
Earlier studies had identified about 1,000 sex-influenced genes in the liver and about 60 gender-biased genes in the brain, but that was only about one-tenth of the number that the UCLA team found in those organs. Gender consistently influenced the expression of thousands of genes in liver, fat and muscle tissues, but the effect was actually more limited in the brain, where hundreds, rather than thousands, of genes showed different expression patterns between the sexes.
"Males and females share the same genetic code, but our findings imply that gender regulates how quickly the body can convert DNA to proteins," said Xia Yang, first author of the study and a postdoctoral fellow in cardiology at the David Geffen School of Medicine at UCLA.
Affected genes were typically those most involved in the organ's function, suggesting that gender mainly influences important genes with specialized roles.
"Many of the genes we identified relate to processes that influence common diseases," Yang said. "This is crucial, because once we understand the gender gap in these disease mechanisms, we can create new strategies for designing and testing new sex-specific drugs."
In the liver, for instance, gene expression involved in drug metabolism differed by sex. This implies that while male and female livers function the same, they may work at different rates.
"Our findings in the liver may explain why men and women respond differently to the same drug," Lusis said.
The authors also said their findings show the need for gender-specific clinical trials of drugs. Most dosages for women are based on trials done on men.
Back to top
July 9th, 2006
I Feel Like I'm in a State of Limbo
SourceURL:http://www.sundaylife.co.uk
By John McGurk
"I'm too sick to work, but not sick enough to receive a life-changing organ transplant" - that's the terrible state of limbo being endured by a chronically ill Ulsterman in 2006.
Belfast man, Colin Kirkpatrick is living in a twilight world - unable to leave his home and just a shell of his former self - as he bravely lives with serious liver disease.
The Methodist College IT support officer suffers from the blood-borne virus, hepatitis C - leaving him with cirrhosis of the liver and a number of other debilitating conditions.
The 6ft 1in south Belfast man's weight has plummeted by four stone - to 10st 7lbs - in less than one year.
He feels constantly tired and is often unable to concentrate or remember significant things.
Yet, in spite of this, Colin is NOT one of the 6,700 people currently on the National Health Service's transplant waiting list - because he is not regarded as being sick enough to receive one of the dwindling number of available organs.
However, campaigning Colin and his devoted wife, Lorraine are not pointing the finger of blame at health service bosses for this sad state of affairs.
Instead, he attributes the reason for his agonising wait to join the list to the worrying drop in UK organ donor numbers.
Said Colin: "I don't want this to sound like 'Colin Kirkpatrick, martyr', as there are people worse off than me who are still not on the transplant waiting list either.
"My main concern is the lack of donor organs in the UK. That is what I am trying to highlight by telling my story."
And Colin's story is, as he describes it, without a trace of self-pity, "a bit of a rollercoaster", since his hepatitis C diagnosis in 2001.
It was then that he was shocked to discover that he had been infected by the virus - known as the silent epidemic - after receiving contaminated blood, during a hospital transfusion in 1979.
Said Colin: "I just hadn't been feeling quite right in October 2001. I had noticed a bit of weight loss and had an all over body itch. I remember that I kept on asking Lorraine if she had changed washing powders.
"I went to the GP to see if he could give me an ointment for the itch. But he immediately ordered a blood test instead. The next day, he told me that I had hepatitis C."
Colin was then referred to a specialist at the Royal Victoria Hospital where he was told just how serious the hepatitis C virus can be.
"He spelt out to me that hepatitis C is life-threatening and can be potentially fatal. My father was with me that day and I was just completely stunned. I don't even remember anything else about the rest of that day.
"Before then, I had enjoyed the best of health. I loved riding motorbikes. I played squash, badminton, five-a-side football. I didn't smoke and I didn't drink all that much. I was definitely fit before then.
"Since then, life has been a bit of a rollercoaster - with ups and downs. Having some hope and then no hope at all, good days - but more bad than good.
"Now, in 2006, I just feel like I'm in a state of limbo.
Added Colin: "I definitely don't want to complain about the time I have been waiting, because it is beyond the control of me, the control of my consultants, beyond the control of anybody.
"I would appeal to anyone even thinking about becoming an organ donor to do it. A transplant will give somebody like me a whole new lease of life."
Added Lorraine: "We are 25 years married this year. Obviously, what has happened has brought its difficulties. But, ironically, it has also brought us closer and made us stronger together."
jmcgurk@belfasttelegraph.co.uk
Back to top
Ecosse: A Slice of History
http://www.timesonline.co.uk/
A team of Scottish surgeons is on the brink of carrying out the NHS’s first live liver transplant, an operation that has very real dangers, writes Gillian Bowditch
John Forsythe knows it could happen any day. The call will come to say a liver has been found and the protocol for the momentous operation will swing into action. Ask how he feels and he says: “Excited and daunted in equal measure. I have very mixed emotions about it.” He is not the would-be recipient of a donated liver, but one of Scotland’s most eminent surgeons and part of the team that will carry out the UK’s first live liver transplant on the National Health Service.
The reality of this pioneering procedure can be difficult for outsiders to contemplate. It involves a living person who is prepared to undergo invasive surgery — at no little personal risk — so that part of their healthy liver can be removed and donated to someone else.
Permission to carry out the £50,000 procedure was granted by the Scottish executive three months ago, and since then Forsythe and his colleagues have been preparing, technically and emotionally, for the operation that will propel them into the medical history books.
Sitting in his office in Edinburgh Royal Infirmary — I’ve seen bigger wardrobes — Forsythe, who is clinical director of the Edinburgh liver transplant unit and president of the British Transplant Society, explains just what live transplantation entails. An easy communicator with a reassuring manner, he exudes none of the hauteur for which surgeons are renowned. A son of the manse, he is not so much playing God as facilitating a route out of purgatory for those desperately sick patients who live in the limbo of the transplant list.
“We’ve been ready to go since April,” he explains. “We have had informal approaches from relatives of patients on the waiting list, but so far nobody has come forward in any formal way to say this is what they want to do. “That is the difficulty in starting a programme like this.
”Live liver transplantation is one of the most challenging procedures a surgeon can undertake. When Forsythe’s team receives news of a potential donor, he or she will undergo a series of medical and psychiatric tests as an outpatient. Only when a team of experts is satisfied can the seven-hour procedure begin with the removal of a section of the donor’s healthy liver. In an adjoining theatre, the recipient will be prepared for life-saving surgery.
Once the section of healthy liver has been removed, the transplant takes place immediately. The donor can then expect to spend at least two weeks recuperating in hospital. The liver is an organ with a remarkable ability to regenerate itself. The operation involves taking a portion — typically about 60%, which is about 13cm long — from a live donor and transplanting it into a patient who is so sick that without a transplant he or she would die within months.
In textbook cases, the donor’s liver regenerates itself within 12 weeks, the recipient’s liver grows and they both go on to lead normal lives. The Edinburgh team already routinely carries out “liver resections” — where part of the liver is removed because of a tumour. As for transplanting a partial liver, that also already happens. The organs are in such short supply they are sometimes divided to give two patients the chance of life.
But live liver donation is more than the sum of these parts and carries considerable risks. In 15% to 20% of cases, significant complications such as infection, bile complications, internal bleeding and thrombosis arise. The risk of death to the donor, however, is 0.5%.
The Edinburgh team has been driven to consider increasingly extreme measures because of the acute shortage of donor organs and the rising demand for livers. The team is now even using poor-quality organs that might not have been considered in the past. Thirty people are currently waiting for a liver transplant.
“It might not sound many, but, sadly, there are only two ways off the list,” says Forsythe. “You either have a transplant or die.” In the past 12 months, 13 patients have died waiting. Time spent on the list is also growing. It used to be unusual to spend 12 months on it; now it is not uncommon to be on the list for 15 months, with all the deterioration that implies.
The significance of what he is planning to undertake is not lost on Forsythe. “Live donor transplantation feels different from any other form of surgery,” he says. “The individual over whom you are holding a scalpel with the intention of inserting it into their body doesn’t need that operation. That is true of a live kidney operation, which is a well-established procedure.
“When you look at live liver transplantation, the stakes are considerably higher. The risks of serious complication and death are significantly higher.” For a doctor whose first responsibility is “to do no harm”, the prospect of carrying out such a pioneering procedure in the full glare of the media spotlight could be overwhelming.
Forsythe, a father of three, rationalises it by saying: “If it were a member of my family and I could see them deteriorating while on the transplant list and I knew the hospital had the facilities and expertise to carry out live liver transplantation, I would say: ‘Why not go ahead?’ ” The ideal donor is somebody who is fit and healthy with good liver function, able to process all the information and face surgery with the maximum chance of coming out without complications. Age is a factor, but there is no hard or fast rule. As Forsythe points out, some 60-year-olds are fitter than some 40-year-olds. Livers do not have to be matched in the way bone marrow or kidneys have to be matched. The recipient and the donor should be from the same blood group and their livers need to be of a comparable size.
You cannot transplant a portion of a small woman’s liver into a 16st man. But the relatively broad compatibility of potential donors and recipients raises as many ethical questions as it does opportunities.“The question you then have to ask is who in the family would you do this for?” says Forsythe. “If you are a parent you would lie in front of a bus for your child, so to a certain extent you have to be defended from yourself. But if you are a competent adult and all of the complications are put before you in a very transparent way, and you still want to do it, it would seem reasonable to me.
”He assumes that the first live transplant will be between close relatives, but would have no problems carrying out the procedure on a gay couple or another close partnership. Donors would be offered lifelong follow-up. “We would expect the first approaches from close family partly because of the risk,” he says.
Forsythe, 48, was born in Northern Ireland and grew up during the height of the Troubles. His father was a minister in the Church of Ireland and his sister married her father’s first curate, so religion permeates his family. He knew from an early age that he wanted to be a doctor and it is no coincidence he has pursued a branch of medicine in which moral and ethical dilemmas are so profound. Not everyone who has experience of live liver donation is an enthusiastic advocate. In January 2002, Mike Hurewitz, a 57-year-old newspaper reporter, died in Mount Sinai medical centre, New York, after donating part of his liver to his brother Adam.
The hospital was the leading pro-ponent of live liver transplants in America. After his death, the programme was suspended and an investigation undertaken. “Woefully inadequate” post-operative care was a factor and Hurewitz’s widow, Vickie, has become a vocal campaigner for an end to all live liver donation.
“I look back now,” she says, “and I think, where were we? Why weren’t we asking any questions?” The inscription on her husband’s headstone reads: He died for brotherly love.
“I can understand her concerns,” says Forsythe, who acknowledges that the case had a damaging effect in America. “If you feel rightly or wrongly that you weren’t given enough information and there is a very bad outcome, it’s natural you are going to feel as this lady does. But if you are from a family where an individual is deteriorating and is on the transplant list, you know all the risks and still want to go ahead, do we as surgeons have the authority to say ‘no’ to that individual?
“If the donor wants it and it does have a very good chance of success — way in advance of many of the treatments for cancer — then is that not a reasonable thing to do?” The pressures of the job are immense. The transplant surgeons regularly work 80-hour weeks.
They can spend one night in three and every third weekend on call with no time off. New directives on junior doctors’ hours mean consultants used to be involved in 10% to 15% of organ retrieval — a process Forsythe says invariable straddles midnight.
Now the figure is 90%. “I could write an Egon Ronay guide to the hospitals of Britain,” he says. He prefers to concentrate on the highs rather than the inevitable stresses. “It can be difficult, but when you have a patient who has been so sick and then recovers to such a degree that you don’t even recognise them, the positive effects are huge. The highs in this job tend to be very high.”Live liver donation was pioneered in Japan and South Korea, where the shortage of donor organs is even more acute than it is in the UK.
“All religions back the idea of organ donation, but culturally there is often a gap between people’s willingness to donate,” says Forsythe, who trained in Newcastle. It is now a well-accepted procedure in Europe and America, and has been carried out in King’s College hospital, London, on private patients, mostly from abroad.
Why has Britain come to the procedure so late? “I don’t know,” Forsythe says. “Is it our natural conservatism? People are certainly uncomfortable placing themselves at such significant risk. “I was hoping other centres in the UK would offer the procedure around the same time as us. That hasn’t occurred.
But Scotland was the first to have a dedicated unit for pancreas transplantation and that then happened for the rest of the UK, so I’m hopeful it will happen with live liver donation.” One thing is certain — the need for liver transplantation is growing as hepatitis C and alcoholic liver disease increase. “It is a significant worry,” says Forsythe.
There is a desperate shortage of donors. Initiatives including a programme about transplantation in secondary schools are being piloted. In the past, 30% of relatives refused to donate the organs of a dead loved one. That figure is now 40% to 45%. “Post-Alder Hey, post-Shipman, post-Bristol, there is a slight loss of trust between those who deliver care and those who receive it in the NHS,” says Forsythe.
“If you are approached at a time of great tragedy in your life, when you don’t even want to be asked what you take in your tea, you are going to react in a reflex manner. But we have a duty of care not just to the recipient but also to the donor and the donor’s family. That is very high in our priorities.” He acknowledges the route pioneering surgeons must navigate between informing patients of a new option and pushing them, however gently, towards it. Booklets have been produced explaining the procedure, but it is left to the patients to make the approach.
“We wanted to make people aware of the possibility of this, but at no point do we want people to feel coerced,” he says. “We would anticipate doing the first procedure this year. It must be very difficult if you are a relative and you see your loved one literally deteriorating before your eyes on the transplant list. “It’s a very fine balance. We provide the information and then step away.”
But Forsythe and his team are ready to step back at any time and push the boundaries of modern medicine in an effort to save a life. All it will take is one selfless and courageous relative to step up to the plate.
The NHS Organ Donor Register Hotline is 0845 606 0400. Liver recipient co-ordinators at the Scottish Liver Transplant Unit are on 0131 242 1721.
Back to top
July 10th, 2006
Society Should be Concerned about Prisoners' Health
SourceURL:http://www.louisianaweekly.com/
By Gail C. Christopher, NNPA
The fight to end health disparities in the United States won't succeed unless local, state and federal leaders place more emphasis on improving the healthcare available to inmates in the nation's jails and correctional facilities.
The current situation is appalling. There are nearly 1 million African Americans in jails and prisons today, comprising 44 percent of the 2.2 million prison population. The inadequate healthcare that they receive while incarcerated contributes to the health disparities that are causing African-American men, women and children around the country to be disproportionately diagnosed with a wide range of diseases.
How does the health of prisoners impact our communities?
Data recently released by the Commission on Safety and Abuse in America's Prisons shows that experts conservatively estimate that between 300,000 and 400,000 inmates across the country suffer from some mental illness. They get little treatment while incarcerated, thus they are returned to their communities with mental conditions that are likely to contribute to undesirable behavior.
Moreover, the Commission's report also found that 1.5 million prisoners are released each year with life threatening, infectious diseases. That means people with HIV, tuberculosis, staph infections and Hepatitis are also returned to their communities where contagious diseases are passed on.
Clearly, our nation has turned its back on the healthcare of prisoners, failing to recognize that most inmates eventually get released, and then bring their health issues back to their families and communities. There are a series of policies in place that are a major hindrance to allowing prisoners to receive proper healthcare.
For instance, it is counterproductive for inmates to lose their Medicare and Medicaid benefits after they are incarcerated. A major hurdle for prison wardens is that even if jails and prisons want to vastly improve healthcare services for prisoners, most lack the resources to do so. The federal government exasperates the problem by taking away Medicare and Medicaid benefits, reimbursements that could be used by jails and prisons to bolster their healthcare services.
Furthermore, this is a shortsighted policy by the government. In many instances, if prisoners received treatment for some of these diseases while they are incarcerated, it would actually reduce the costs associated with their health once they are released. Take Hepatitis C, for instance. Many prisoners don't receive any treatments for this disease. Years later when they are back in their communities, they may need liver transplants, which will cost the government far more than the treatments.
The Commission's extensive report also noted another source of healthcare problems. Many prisons have adopted inmate co-payment systems. The inmates must pay between $2 and $15 to visit the doctor. Such plans were implemented to curtail inmates from making unnecessary doctor requests. But it also has another impact: those who need to see a doctor often don't because they have no funds in their prisoner accounts.
This type of system doesn't seem fair when inmates have little control over whether they get chosen for wage paying jobs while incarcerated. Some have to depend on their families to deposit money in their prison accounts. But many inmates come from low income environments where that is not possible, so they go without healthcare.
Another indication of how our society feels about inmate healthcare is demonstrated by states that issue special licenses for physicians who can only work in jails or prisons. These doctors have failed to display a level of skill and competence that would allow them to treat the general public, yet they are allowed to work on inmates. The Commission report notes that every six or seven days last year, a prisoner died in a California correctional facility from malpractice or inadequate healthcare.
The Commission report discloses evidence of gross neglect regarding healthcare for prisoners. African Americans must realize that with nearly one million blacks behind bars we must advocate for prison reform. Building new correctional facilities should not be a priority; providing humane conditions, including adequate healthcare, should be at the top of the public policy agenda for prisons.
Gail C. Christopher is vice president for health, women and families at the Joint Center for Political and Economic Studies, and director of the Joint Center Health Policy Institute.
Back to top
85% of Rural Chinese HIV-Positives also Have Hepatitis C
SourceURL:http://www.aidsmap.com
Rural Chinese villagers with HIV have high rates of undetected hepatitis C (HCV) infection, and are potentially compromising treatment with antiretroviral drugs, according to a study published in the journal AIDS last month.
In a cross-sectional study done in four villages in Shanxi province, where blood-selling was common practice in the 1990s among farmers needing extra income, a collaborative team of Chinese and American researchers has found that 85% of HIV-infected villagers were co-infected with HCV.
In their report, authors Han-Zhu Qian of the Chinese National Center for AIDS/STD Control and Prevention and Sten Vermund of Vanderbilt University in the United States call on the Chinese government to do more to identify and treat people infected with both HIV and hepatitis C.
"The Chinese government has initiated free ART programs for the infected rural plasma donors since 2003, but these programs do not provide free HCV screening or interferon-based treatments that are expensive and beyond the affordability of these poor farmers", said the report.
"While providing free HIV testing and treatment in these rural communities, Chinese government should make HCV testing available and affordable to these rural residents and consider HCV co-infection in training and patient care."
Among the 3,062 villagers who were tested for both HIV and HCV, after being interviewed about their lifestyles and risk factors, HCV was more prevalent (12.7%) than HIV (1.3%). It is thought this may be so because HCV is transmitted more effectively via injections or unsterilised intravenous therapy equipment. It may also be more prevalent because HCV appeared among Chinese blood donors earlier (in the late 1980s) than HIV.
However the authors also noted that not all villagers participated in the study (85 percent participation rate) because, unlike many studies in China which enjoy close to 100 percent participation rate, the study team only tested those who gave informed consent after attending 'village health camps'. Most of those who did not participate were young - under 35 yeas old - and while most had standard reasons for not participating such as "too busy" or "out-migration for short term employment", some said they were not willing to be tested for HIV because they did not wish to know their status.
While HCV was much more prevalent, a significant number of those with HCV (8.7%) were also infected with HIV. And the majority of villagers with HIV were co-infected with HCV.The study authors said this group of people were likely to do very poorly, less likely to respond well to antiretroviral treatment and more likely to progress rapidly to AIDS.
“HCV may facilitate HIV disease progression, increase the incidence of liver toxicity associated with certain antiretroviral regimens, and represent a leading cause of morbidity and mortality among AIDS patients receiving antiretroviral therapy (ART)” said the report.
Blood and plasma selling was a widespread practice in the largely agricultural central Chinese provinces of Henan and Shanxi in the early 1990s where farmers struggled to earn enough to feed their families. After blood was collected from donors, an injection of pooled packed red cells of the appropriate blood group was given to enable donors to recover quickly between donations. Thus blood collection centres became a potent means of transmitting blood-borne infections such as HCV and HIV.
During the nineties, China moved from a socialist command economy with an extensive welfare system including primary healthcare, to a market economy where services, including healthcare have to be paid for. While average incomes have risen rapidly in China over the past decade, the biggest gains have been among urban Chinese. Rural Chinese have seen their incomes remain static or even drop, while their costs have risen.
Many farmers have sought alternative means of earning a living such as taking short-term factory work, travelling to the cities to work as 'rubbish pickers' for a few weeks after the harvest season, or until recently, selling their blood. In Qian et al's study, 29.5% of participants reported ever having sold blood or plasma to supplement their income.
Private blood collection centres started up in some of China's poorest agricultural provinces such as Henan, Shanxi, Shangdong, Anhui and Hebei in the late 1980s and prospered. Although all such centres have been officially banned, studies like this indicate their legacy, particularly the impact on China's health services, is only now being assessed.
"Our study findings underscore the importance of improved HIV treatment and prevention in rural, former plasma-donation communities, including diagnosis and basic care for HCV co-infection."
References:
Qian, Han Zhu et al. Co-infection with HIV and hepatitis C virus in former plasma/blood donors: challenge for patient care in rural China AIDS 20: 1429-1435, 2006.
Back to top
Pegylated Interferon Aids in Post-Transplant HCV
SourceURL:http://www.medpagetoday.com
By Neil Osterweil, Senior Associate Editor, MedPage Today
Reviewed by Zalman S. Agus, MD; Emeritus Professor at the University of Pennsylvania School of Medicine.
MedPage Today Action Points
Explain to interested patients that this study indicates that patients who have recurrent hepatitis C viral infections following liver transplantation may be able to have good control of the disease with antiviral therapy consisting of a pegylated interferon and ribavirin.
Review
VALENCIA, Spain, July 10 -- With a combination of pegylated interferon and Rebetol (ribavirin), liver transplant recipients with recurrent hepatitis C (HCV) infection respond as well as non-transplant patients, according to researchers here.
One third of patients treated with either standard Intron A (interferon alfa-2b) plus Rebetol, or Rebetol plus a pegylated interferon -- either Pegasys (pegylated interferon alfa-2a) or PegIntron (pegylated interferon alfa-2b) -- had a sustained virologic response, reported Marina Berenguer, M.D., and colleagues of the Hospital Universitari La Fe in Valencia. However 40% of these patients had to halt either the interferon, Rebetol, or both, within 48 weeks because of adverse reactions.
"Our results indicate that response of hepatitis C liver transplant patients to pegylated interferon-ribavirin can closely mirror the response obtained in the non-transplant population," the investigators wrote in the July issue of Liver Transplantation.. "The tolerance though is unsatisfactory, and rejection remains a matter of concern in these patients."
In an accompanying editorial, James R. Burton, Jr., M.D., and Hugo R. Rosen, M.D., of the University of Colorado in Denver said that the study provides important information for the management of patients with recurrent HCV infection following liver transplantation.
"We still need randomized controlled trials of pegylated interferon and ribavirin compared to standard interferon and ribavirin to determine if improved tolerability equates to higher rates of sustained virologic response," the editorialists wrote.
They suggested a potential treatment algorithm until further studies are available. "Assuming the presence of fibrosis in the transplant recipient does not significantly reduce the likelihood of virologic response, we can probably afford to take a 'wait and treat progressive disease' approach, reducing risk of rejection, allowing lower doses of immunosuppression and increasing the likelihood of patient tolerability to therapy," they continued.
Dr. Berenguer and colleagues conducted a retrospective analysis looking at 67 liver transplants patients with recurrent HCV, 92.5% of whom were infected with HCV genotype 1. In all, 51% of the patients had stage 3 fibrosis, and 13% had stage 4 fibrosis.
Forty-six percent of the patients had received standard Intron A with Rebetol, and the remaining 54% were treated with either Pegasys or PegIntron plus Rebetol.
The investigators looked at only those patients for whom at least six months of follow-up data were available following discontinuation of antiviral therapy.
Under the protocol, patients would receive 48 weeks of antiviral therapy with erythropoietin and/or granulocyte colony stimulating factor given as needed.
The primary study endpoint was sustained virologic response, which the investigators defined as HCV RNA negativity on polymerase chain reaction assay at six months after the end of treatment.
They also looked at biochemical response, defined as normalization of serum alanine aminotransferase and aspartate aminotransferase, and end of treatment virologic response rates.
In all, 46% of patients had an end of treatment response, and 33% had sustained virologic responses. There were significant differences between patients treated with the standard or pegylated interferons, however, with only 13% of patients who received Intron A having a sustained virologic response, compared with 55% of those who received a pegylated interferon (P= 0.001). However, patients who received a pegylated interferon were treated earlier than those receiving standard interferon.
Premature discontinuation of one or both components of the treatment regimen occurred in 40% of patients because of adverse events, which included anemia, rejection episodes, and drug intolerance. An additional 57% of patients had adverse events, mainly anemia, neutropenia, or thrombocytopenia, that required dose reductions of either interferon (in 36% of all patients) or ribavirin (45%).
The ability to achieve a sustained virologic response did not appear to depend either on previous (pre-transplant) antiviral therapy or on the type of immunosuppressant used.
Predictors for sustained virologic response include type of antiviral therapy used, erythropoietin use, compliance, and an early virologic response, defined as a decline in viral load higher than 2 logs from baseline. In multivariate analysis, however, only early virologic response remained as an independent predictor of a sustained response. No difference in sustained virologic response was seen with respect to the presence or absence of significant fibrosis.
There were a total of six episodes of rejection-two chronic, and four acute. Three of the four patients who developed chronic rejection had a sustained virologic response, but neither of the patients with acute rejection had a sustained response.
The lessons of the study, the authors said, are that:
- Pegylated interferons in combination with Rebetol induce a significantly higher rate of HCV clearance in liver transplant recipients.
- A lack of early virologic response at three months can predict treatment failure.
- The type of calcineurin inhibitor used does not determine the outcome of antiviral therapy.
- Prior failure to respond to antivirals does not predict the outcome of antiviral therapy post-transplant.
They also found that "although HCV clearance is achieved in a significant proportion of HCV-1b infected liver transplant recipients treated with pegylated or standard interferon- ribavirin, treatment may be hampered by the development of severe rejection, potentially leading to graft loss."
Additionally, "rejection following the use of interferon pegylated interferon therapy is difficult to predict with current easily obtainable variables, but appears to be more common with the pegylated form of interferon," they wrote.
"The most recent paper from the Valencia group adds to our rapidly evolving understanding of how best to manage patients with HCV, underscoring that some rules apply and others do not," Dr. Burton and Dr. Rosen wrote in their editorial. "We look forward to results from multicenter studies to more fully define the rules for treating these very challenging patients."
Primary source: Liver Transplantation
Source reference:
Berenguer M et al. "Efficacy, Predictors of Response, and Potential Risks Associated With Antiviral Therapy in Liver Transplant Recipients with Recurrent Hepatitis C." Liver Transpl 12:1067-1076
Additional source: Liver Transplantation
Source reference:
Burton Jr., JR and Rosen HR. "Treatment of HCV Recurrence: Do the Pretransplantation Rules Apply?" Liver Transpl 12:1044-1048
Back to top
No Insurance? No Medicare/Medicaid? You Are Less than Half as Likely to Receive Treatment for Hepatitis C than Patients with Private Insurance
SourceURL:http://biz.yahoo.com/
Your Doctor's Hepatitis Case Load Determines Whether You Get Treatment
Treatment Patterns for Hepatitis C to Follow the HIV Model of Maintenance Therapy, According to a New Report from Decision Resources
WALTHAM, Mass., July 10 /PRNewswire/ -- Decision Resources, Inc., one of the world's leading research and advisory firms for pharmaceutical and health care issues, finds that patients without insurance who do not qualify for Medicaid or Medicare are less than half as likely as patients with private insurance to undergo treatment for hepatitis C. Patients reliant upon Medicaid or Medicare are also less likely to undergo treatment than patients with private health insurance.
The new PhysicianForum report entitled Hepatitis C: Are We on the Verge of a Paradigm Shift? Focus on How New Antivirals Will Be Integrated into Medical Practice, also finds that the amount of hepatitis C patients a doctor has affects the treatment process.
"Clinicians with a low hepatitis C patient load appear to be undertreating the disease," said Mary Fletcher-Louis, analyst at Decision Resources. "Clinicians who have a high hepatitis C case load (more than 50 patients per month) say they treat 52% of hepatitis C patients at the time of initial diagnosis. The corresponding estimate by clinicians with a lower case load is only 40% of patients."
New Paradigm Shift?
Surveyed clinicians say emerging oral polymerase and protease inhibitors have the potential to convert the hepatitis C market from fixed duration therapy to a maintenance therapy paradigm, following the HIV model. At least 40% of surveyed clinicians expect to use emerging oral polymerase or protease inhibitors as maintenance therapy. To achieve this usage, emerging agents will need to prove efficacy in long-term suppression of viral load. Because the largest segment of the treated population is aged only 40-60 years, achieving clinician acceptance of long-term maintenance therapy will have huge commercial significance.
About PhysicianForum
PhysicianForum is a primary research service from Decision Resources that offers access to high volume-prescribing physicians, specialists, and managed care organization representatives in the United States; analysis of events and survey participants' responses to them; insight into prescribing patterns; and an examination of the implications of events and issues for the pharmaceutical market.
Hepatitis C: Are We on the Verge of a Paradigm Shift? Focus on How New Antivirals Will Be Integrated into Medical Practice is based on a U.S. survey of 20 managed care pharmacy directors, 102 gastroenterologists, and 33 hepatologists. Their responses were compared to assess similarities and differences of opinion regarding clinical, economic, and scientific factors.
About Decision Resources
Decision Resources, Inc. (http://www.decisionresources.com) is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.
For more information, contact:
Elizabeth Marshall
Decision Resources, Inc.
781-296-2563
emarshall@dresources.com
Back to top
Increased Hepatic Encephalopathy in Diabetes with HCV Cirrhosis
SourceURL:http://www.gastrohep.com
Diabetic patients with Hepatitis C cirrhosis have more severe hepatic encephalopathy than non-diabetic patients, reports July's issue of the American Journal of Gastroenterology.
An increased ammonia level of gut bacterial origin is an important mediator in the pathogenesis of hepatic encephalopathy.
Constipation is a frequent precipitant of hepatic coma.
Diabetes mellitus may be associated with delayed gastrointestinal transit.
Dr Samuel Sigal and colleagues from New York speculated that its presence in patients with Hepatitis C-related cirrhosis would predispose to hepatic encephalopathy.
The investigative team assessed the severity of liver disease and presence of diabetes mellitus in a cross-sectional study.
The team evaluated 65 patients with Hepatitis C-related cirrhosis attending a liver transplantation clinic.
Hepatic encephalopathy was present in 95% with diabetes -- American Journal of Gastroenterology
A modified Child-Pugh score that excluded hepatic encephalopathy was calculated.
The investigators assessed the frequency and severity of hepatic encephalopathy in diabetic and nondiabetic patients.
Clinical severity of cirrhosis and results of neuropsychometric testing in diabetic and nondiabetic patients with hepatic encephalopathy were compared.
The investigators found that 83% had hepatic encephalopathy.
About 30% had diabetes mellitus.
Hepatic encephalopathy was present in 95% of patients with diabetes and 78% patients without diabetes.
The team noted that hepatic encephalopathy was greater in diabetic than in nondiabetic patients.
In both the mild and severe hepatic encephalopathy categories, severity of liver disease in diabetic patients was otherwise milder than in the nondiabetic patients.
Dr Sigal's team commented, "Diabetic patients with Hepatitis C cirrhosis have more severe hepatic encephalopathy."
"Diabetic patients have severe hepatic encephalopathy at earlier stages of biochemical decompensation and portal hypertension compared with nondiabetic patients."
Am J Gastroenterol 2006: 101(7): 1490
Back to top
July 11th, 2006
Safer Needles a Must, Lab Worker Says
SourceURL:http://www.cbc.ca/
CBC News
A lab technician who contracted hepatitis C on the job has thrown his support behind a government plan to introduce safer needles at Nova Scotia hospitals.
Matthew Dubois says the disease has left him too tired and too confused to work, so he's been off the job for three years.
"It's a very devastating disease to have," he told an all-party legislative committee Monday in Halifax.
Dubois believes he caught hepatitis C, -- virus that can seriously damage the liver,-- when he stuck himself while handling a used needle.
He supports a government bill that would make safety engineered needles mandatory in all provincially run health facilities, but said the regulation should also be extended to private clinics.
"If you do have exemptions [and] loopholes, these diseases are going to run right through those loopholes and you're going to have a population of yellow zombies in a decade," Dubois said.
Nova Scotia Nurses Union spokesman Stephen Topshee wants the bill amended to include all workplaces where needle injuries can happen, including schools, jails and municipal waste facilities.
Needle-stick injuries in hospitals alone cost the province at least $2.5 million a year, Topshee told the committee.
Back to top
Justice for Mum
SourceURL:http://www.dailyrecord.co.uk
By Annie Brown
Eileen O'hara died after contracting hepatitis c from infected blood given to her during surgery. Her daughters' fight for answers goes on...
IT'S more than three years since Eileen O'Hara's death and her daughters are still not sure why she died.
They know hepatitis C killed her and that the disease came from an infected blood transfusion but the answers end there.
The questions, on the other hand, stretch on forever.
The family, like all of those affected by the hepatitis C scandal, had hoped Health Minister Andy Kerr would decide the debacle of infected transfusions warranted a public inquiry.
But sadly for all those involved he has recently ruled out this option.
It's a huge disappointment for Eileen's daughters Roseleen, 40, Annette, 40 and Eileen, 38, but it didn't surprise them.
Roseleen said: "The response has been one of indifference. Dodging the issue.
"We want answers and then everyone can move on. All it does is raise your suspicions. What are they hiding? Why can't we have an inquiry? Could it happen again?
"We don't even know where that blood came from."
The sisters are also part of a separate 150-strong band who are asking for a judicial review into the deaths of their loved ones.
They would rather grieve than fight but feel they owe it to their mother and the other victims to push on.
Eileen, from Glasgow, had been so frustrated with bureaucratic stonewalling over her infection that she contacted lawyer Frank Maguire who agreed to act on behalf of the hepatitis victims.
She died, aged 72, before she could attend the appointment with him.
Campaigners claim up to 3500 people were infected with hepatitis C between the Seventies and early Nineties, but no one knows for sure because they haven't all been traced.
Roseleen said: "There are people out there who are infected and don't even know it. It's irresponsible. People could be saved. They could be taking precautions to stop them infecting their families."
Recently Frank uncovered a letter from the Scottish National Blood Transfusion Service to the Scottish Office stating a number of infected patients couldn't be tracked down without extra resources.
Ministers claimed everything had already been done to track down infected patients but Eileen was among those in the dark about contracting hepatitis C.
She had one heart operation in 1985 to insert a pig valve and another in 1991 but it's unclear which blood transfusion infected her.
She wasn't diagnosed until 1995 when the hepatitis had caused cirrhosis of the liver. By then she was a dying woman.
She had had symptoms for a couple of years but even now GPs haven't been trained to recognise them.
Eileen didn't smoke or drink and she did everything that the doctors told her to.
Roseleen said: "Everyone loved my mum. She was just a kind, happy person who knew she had been given this chance with the heart valve.
"Whatever a doctor told her to do, she did it to the absolute letter and she never complained."
Even her medical records noted how pleasant she was.
She reluctantly went to her GP in 1993 after months of feeling weak and lethargic.
When blood tests showed her liver function was impaired the doctor started to question how much she was drinking.
Annette said: "My mother was completely teetotal. She just kept asking her 'How much alcohol do you drink?' and my mum kept saying she didn't drink.
"The blood tests would come back and she would say 'Are you sure you're not drinking? You must be'.
"That really upset my mum."
The problem was blamed on her heart valve and Eileen continued to feel so weak that at times she had to use a wheelchair. In early 1995 her stomach was swelling, her liver and spleen was enlarged and the suspicion was that she had lymphoma.
She was admitted to Stobhill Hospital in Glasgow for investigation, and a liver biopsy revealed she had cirrhosis of the liver and hepatitis C.
They were told she had contracted hepatitis fromone of the blood transfusions given to her during a heart operation. Ironically her heart valve was working perfectly.
Annette said: "All she knew was that she had cirrhosis of the liver and that was like a death sentence.
"She was angry and she remained angry about getting hepatitis C until the day she died.
''No one gave us any help and advice. No one told my mother what to do or how to deal with her condition."
It was only because Annette was a nurse that she was able to tell her sisters and her mother to be careful of spreading the infection.
Before the diagnosis Annette was living at home and all the girls had borrowed their mum's earrings, shared nail clippers and tweezers which could have caused cross infection through blood from a nick. Annette had cleaned up Eileen's blood from a urine infection without realising her mother had hepatitis.
Roseleen said: "If my mum had been traced that risk would have been eliminated but even after diagnosis, not one person ever came to tell my mum what and what not to do.
"To me that's scandalous."
Annette called the blood transfusion service but was offered no advice and was told the blood had been given in good faith. Annette had to organise her own hepatitis test which thankfully came back negative.
Eileen was too ashamed to tell her two brothers she had it because of the stigma.
Roseleen said: "In hospital there was a sticker in front of her case notes - 'hepatitis C risk' - and she was mortified, she knew people who worked there."
She was also paranoid that she would get a cut and spread the disease.
Eileen was not told where the blood had come from, only that some batches were from American and Scottish prisoners - a high-risk group.
Roseleen said: "Imagine my mother, a wee woman from Glasgow, being told she might have got blood from American prisoners."
As far as the family are aware, there was no attempt to trace the other recipients of the blood she received. Roseleen said: "The next move should have been to do that. It is incredible that you could be walking about and you don't know you have it until you get liver damage. By then it's too late."
The women say it is impossible to get closure until their questions are answered.
In the meantime their anger remains fresh.
Roseleen said: "I have two children who don't have their grandmother, that person who goes to school plays and surprises them on birthdays and Christmas.
"We were so close to my mum and now we don't have that.
"It's all the little things you miss that mean so much."
FrankMaguire is determined the fight will go on even though Andy Kerr has said no to a public inquiry.
He said: "The minister has said there is not enough new evidence to hold an inquiry but where is the old evidence?
"We still don't know why and how this happened because no one will tell us.
"He says it all happened a long time ago but there are people dying now because of it.
"We still want an inquiry, we want donors and recipients traced and GPs educated about the situation.
"It's a public health issue and we need to know what went wrong, so that it never happens again."
Back to top
City Council to Discuss Controversial Needle Exchange
SourceURL:http://news.yahoo.com
The San Diego City Council will consider Tuesday whether to resume the city's clean needle exchange program, which health officials have said will help prevent the spread of HIV
Mayor Jerry Sanders has pushed for the resumption of the city's needle exchange program, which he called a "vital public health service."
"Statistics show that clean syringe programs greatly help reduce the transmission of hepatitis C and HIV that occurs with the sharing of syringes," the mayor said last week.
Opponents contend that needle exchange programs promote drug use.
San Diego's program was discontinued last July following the resignations of Councilmen Michael Zucchet and Ralph Inzunza, who had supported it. Their votes were needed to sustain a bi-weekly state of emergency declaration by the City Council required to keep the program running.
Under a new state law, the council doesn't have to repeatedly declare a state of emergency to keep the needle exchange program going. It now requires only needs a single, simple majority vote.
According to Dr. Jim Dunford, a UCSD Medical Center physician and the city's medical director, needle exchange programs are an effective way to reduce the transmission of HIV/AIDS and hepatitis C.
Nationwide, injection drug use is responsible for about one-third of all HIV infections and almost two-thirds of hepatitis infections.
If approved, the program will be operated and paid for by Alliance Healthcare Foundation.
Nearly 350,000 used syringes were collected in the city between 2002, when the needle exchange was first initiated, and 2005, when it ceased, according to Alliance Healthcare Foundation officials.
Back to top
Tories to Pledge More Than $1B for Blood Victims
SourceURL:http://www.ctv.ca
Uncompensated victims of the tainted blood scandal will soon receive recompense from a fund of more than $1 billion set up by the Conservative government, an internal government document reveals.
"The government has approved about $1 billion dollars in compensation to about 5,500 Canadians," CTV's Ottawa Bureau Chief Robert Fife reported Tuesday. "The cabinet decision was made last month ... but the Prime Minister wanted to wait for the announcement sometime in July."
The internal communications plan states that Health Minister Tony Clement was supposed to outline "the framework agreement on Hep C" in Toronto last Thursday, The Canadian Press first reported.
It was delayed because Harper wanted to participate in the announcement but couldn't because he was in the U.S. last week.
The new date for the announcement is July 24, CP reports.
Currently, under a 1998 federal-provincial package, financial compensation only went to victims infected with Hepatitis-C between 1986 and 1990.
The Conservatives made it an election pledge that they would equally compensate all victims of the scandal, which took place in the 1980s and 1990s.
"Stephen Harper had made it very clear during the election campaign that if the Conservatives were elected they would compensate the people who had been left out of an original deal to compensate people who contacted Hepatitis C through blood transfusions in hospitals," said Fife.
Initially, the government only compensated those within the four-year block, claiming they could not have prevented the infections that occurred before 1986.
However, that was later rebuffed when officials concluded that blood-screening tests -- which could have prevented infections -- were accessible before 1986.
The new funding will probably exceed the $1.1-billion settlement from 1998 that government distributed to about 10,000 victims, CP reported. The remaining victims make up about 5,500 people.
It is still unclear how government will distribute the money, although 1998's compensation went to victims based on how sick they were. Then, as victims got sicker, the government gave them more money.
Some believe that the government may instead decide to pay victims with lump-sums.
But Jeff Rice, the Hep-C program coordinator for the Canadian Hemophilia Society, argues that victims might not plan for their long-term health care if given the money all at once.
"We're a bit concerned that if people who haven't had any compensation and get the lump sum, they may not use that in the best way," said Rice. "A lot of people will use it to pay off mortgages and stuff, and not realize that they may be OK health-wise now, but down the road people with Hep-C can become more ill."
Rumours of an announcement have been surfacing among victims' groups in recent weeks. Victims'advocate Durhane Wong-Rieger had heard of the upcoming pledge but said many have become skeptical of receiving any compensation.
"It's been so awfully long, that most people's attitude is, 'I'll believe it when I see it'," she said.
She said that even if government signs a package, victims still have to go through rigorous obstacles -- including tons of paperwork and clearing the settlement in court -- before they actually see any money.
The upcoming package does not involve any provincial participation.
Back to top
Coagulopathy Does Not Prevent Thromboembolism in Cirrhosis
SourceURL:http://www.gastrohep.com/
Low serum albumin strongly predicts the risk for venous thromboembolism, independent of platelet count, find researchers in this month's American Journal of Gastroenterology.
Despite the endogenous coagulopathy of cirrhosis, some patients with cirrhosis experience thrombophilic states.
Dr Patrick Northup and colleagues from Virginia determined the incidence and predictors of venous thromboembolism.
The research team assessed deep vein thrombosis, and pulmonary embolism, in hospitalized patients with cirrhosis.
The team performed a retrospective case-control study in a tertiary-care teaching hospital over an 8-year period.
A total of 113 hospitalized patients with cirrhosis with a documented new venous thromboembolism were compared to controls.
The team determined risk factors for venous thromboembolism using univariate and multivariate statistical analyses.
Less than 1% of all hospitalized patients with cirrhosis had a venous thromboembolism.
Less than 1% of admissions resulted in a thromboembolic event -- American Journal of Gastroenterology
The team found that traditional markers of coagulation such as international normalized ratio, and platelet count did not predict venous thromboembolism.
In the univariate analysis, serum albumin level was significantly lower in cases than controls.
Using multivariate analysis, the researchers noted that serum albumin remained independently predictive of venous thromboembolism, with an odds ratio of about 0.3.
Dr Northup's team concludes, "Approximately 1% of admissions involving cirrhosis patients resulted in a new thromboembolic event."
"Low serum albumin was strongly predictive of increased risk for developing venous thromboembolism, independent of international normalized ratio or platelet count."
"Serum albumin deficiency may indicate low levels of endogenous anticoagulants."
Am J Gastroenterol 2006: 101(7): 1524
Back to top
July 12th, 2006
Sexual Dysfunction Common for Men with Hepatitis C
SourceURL:http://www.reutershealth.com
NEW YORK (Reuters Health) - Men chronically infected with hepatitis C virus often suffer from sexual dysfunction, and it seems to have nothing to do with their age or with underlying depression, new study results suggest.
Dr. Edmund J. Bini and associates recruited 112 men with hepatitis C virus (HCV) infection and a comparison group of 239 "control" subjects treated at the Veterans Affairs New York Harbor Healthcare System in New York City from January 2004 through March 2005.
The subjects completed questionnaires to assess sexual function, depression, and their health-related quality of life.
As reported in the American Journal of Gastroenterology, the researchers found 54 percent of the HCV-infected men reported they were not sexually satisfied compared with 29 percent of the controls.
After adjusting for demographic and clinical factors, the HCV-positive patients were more than three times more likely to report sexual dissatisfaction.
The same pattern was seen for the other areas of male sexual function assessed -- sex drive, erectile function, ejaculation, and sexual problem assessment -- regardless of the men's marital or socioeconomic status or age.
The men with hepatitis also reported worse health-related quality of life. Conversely, only the control subjects showed a link between depression and sexual dysfunction, even though HCV was associated with higher depression scores.
Bini and his team point out that patients with diabetes, kidney failure, prostate cancer, and alcohol abuse were excluded from the study, so those disorders could not be the reason for the findings.
Abnormalities in hormone regulation resulting in low testosterone levels might be responsible for the sexual dysfunction in men with hepatitis C, the investigators suggest.
"Based on these findings," they say, "HCV infection should be considered in the differential diagnosis of sexual dysfunction in men."
SOURCE: American Journal of Gastroenterology, June 2006.
Back to top
Needle Exchange Program to Resume
SourceURL:http://www.signonsandiego.com
By Amy Oakes
UNION-TRIBUNE STAFF WRITER
Clinics in North Park, East Village reinstated
San Diego rejoined scores of cities across the country yesterday when it reinstated a needle exchange program for drug users.
In a 6-1 vote, the City Council brought back the program, abandoned a year ago when it lost political support. Mayor Jerry Sanders, the city's former police chief, led the move to reinstate the mobile clinics in the face of opposition from some residents of North Park and the East Village, where the exchanges take place.
San Diego will again be the county's only city with such a program, which includes drug counseling. It joins eight other cities in the state, along with 14 California counties, to offer such a service. San Diego County supervisors have repeatedly rejected proposals for such programs over the past two decades.
Supporters say the program is key to battling AIDS and hepatitis C, which can be spread by sharing dirty needles. Opponents say the government is, in effect, promoting drug use.
Joel Harrison, who lives a block from the North Park needle exchange site, said he'll be glad to see the program return. At first, he was upset about having drug users near his home. But he said he was swayed after doing research about the rate of hepatitis C and HIV in the neighborhood.
"The mobile clinics are helping get dirty needles off the street," Harrison said after the meeting.
But Luauna Stines, a pastor from Ramona who addressed the City Council, said the money would be better spent on faith-based drug counseling.
"They don't need another needle," she said. "hey need direction."
The City Council first approved a pilot exchange program in November 2001 on a 5-4 vote. Funded by the Alliance Healthcare Foundation and operated by Family Health Centers of San Diego, the program was launched in the East Village the next July.
A trailer was set up on 15th Street just two blocks from police headquarters on Thursday evenings. In February 2003, the program expanded to North Park, where a trailer parked at 31st Street and University Avenue every Friday morning.
In three years, 348,832 dirty syringes were collected and 285,524 clean ones were distributed, according to the city. Most were traded at the East Village location, which had about 34 clients daily, said Dr. James Dunford, medical director for the city's paramedics.
But until this year, local jurisdictions had to declare a state of emergency every two weeks to keep their needle exchange program active. The City Council lost votes to approve a state of emergency in July 2005 when Councilmen Michael Zucchet and Ralph Inzunza resigned. The program ceased that month. However, the trailers continued to provide drug counseling.
In January, Ben Hueso and Kevin Faulconer were elected to replace Inzunza and Zucchet. Also, a new state law allows local jurisdictions to authorize the exchanges without declaring a state of emergency every two weeks.
With a full council and a new mayor, proponents of the program sought to revive it. Alliance Healthcare, a local nonprofit organization, pledged to give $386,400 to pay for supplies and staffing the program for two years.
Voting for the program yesterday were Council President Scott Peters and council members Toni Atkins, Tony Young, Donna Frye, Hueso and Faulconer.
Councilman Brian Maienschein cast the lone vote in opposition. Jim Madaffer, who opposes the program, was absent yesterday.
In remarks before the council vote, Leslie Wade, who represented the East Village Association, praised the exchange program. But, she said, as more people move into the neighborhood, it might be time to consider a new location for the mobile clinic.
Atkins said she hopes to develop a policy for future sites soon. She stressed the need for community input as to where the needle exchange should be allowed.
"These are difficult to site," she said, adding that the North Park location may be the site of a future library.
Patrick Freeman, a heroin user who said he has been clean for 16 months, told the council that the workers at the mobile clinics were the only ones to reach out to him. Although he didn't take advantage, he appreciated their efforts.
"The advice was there," he said. "They tried to help me."
Back to top
July 13th, 2006
USC Center Is Latest with Transplant Woes
http://ktla.trb.com
From the Los Angeles Times
By Charles Ornstein and Tracy Weber, Times Staff Writers
University Hospital has among the nation's highest death rates for those receiving new livers, data show. The state plans to investigate.
The liver transplant program at USC University Hospital in Los Angeles has one of the highest death rates in the nation, with twice as many patients as expected dying after their surgeries, according to data released this week.
The most recent statistics show that 38 USC patients who received new livers from January 2003 to June 2005 died within a year of surgery – 19 more than expected, according to the Scientific Registry of Transplant Recipients. The agency, which analyzes data on behalf of the federal government, determines the expected rate for each center after adjusting for such factors as patient age and condition and organ quality.
The troubles at USC follow scandals that forced the closure of two other liver transplant programs in Southern California last year: at St. Vincent and UCI medical centers. But USC's reach is far greater: It performed 92 transplants last year, about three times as many as St. Vincent and UCI combined did in any recent year.
A review by The Times shows that the one-year survival rate at USC's liver transplant center, the third-largest in the state, steadily dropped since at least 2002, hitting a low of 75.8% in the new report. That is far below the U.S. average of 86.6%.
Just four adult centers nationally had lower survival rates over the same period.
USC's rate also falls below federal and state standards to receive certification and funding from government programs. The Medicare program requires a raw survival rate of 77%, and the Medi-Cal program demands 80%.
Dr. Rick Selby, director of USC's liver transplant program, said patients should not be alarmed by its survival rate.
"It's clearly not because we don't know what we're doing," he said, noting that the transplant team has remained virtually unchanged in recent years. In fact, for a period, USC's survival rate was above the national average.
"We know what we're doing," he said. "We don't want to be painted with a broader brushstroke as an incompetent program."
The California Department of Health Services said Wednesday that it found the newly released statistics "a concern" and will begin investigating. Meanwhile, the U.S. Centers for Medicare and Medicaid Services, already under fire as lax in oversight of transplant programs, is conducting a broad review of all federally funded centers.
After learning of USC's numbers from The Times, Cheryl Rader questioned the treatment her husband, John, received there.
He received a new liver at USC in June 2005. The transplant was a chance to regain a life derailed by a progressive liver disease -- but John, 64, died 3 1/2 months later of a post-transplant infection.
"He shouldn't have died," his widow said. "It was a tragedy that he died. It shouldn't have happened."
Selby offered various explanations for the program's record -- including a very sick patient pool -- but studies and transplant experts indicate that the reasons offered cannot account for the results.
Dr. John R. Lake, director of liver transplants at the University of Minnesota Medical Center, said the expected survival rate for each hospital takes into account the severity of illness. He also said that with the large number of transplants performed by USC, the results cannot be attributed to chance.
"You have twice as many deaths as expected," he said. "It's pretty hard to chalk that up to bad luck."
Lake chairs the liver and intestinal organ transplantation committee of the United Network for Organ Sharing, the federal contractor responsible for the safety and equity of the national transplant system.
He and other experts expect the group to immediately demand answers from USC and visit the private hospital in Boyle Heights to investigate.
Dr. Goran Klintmalm, head of the Baylor Regional Transplant Institute in Dallas, said the two top liver surgeons at USC are "very good guys. They know the business."
But "when this happens, what comes to my mind is essentially a question of what the hell is going on?" he said. Outside scrutiny of the numbers "would force the institution to get in line and get their act together."
The troubles at USC University Hospital, owned by the for-profit Tenet Healthcare Corp., only adds to concerns about the performance and oversight of liver centers in the Southland.
St. Vincent in Los Angeles halted its liver program in September after officials admitted that in 2003 its doctors improperly arranged a transplant for one patient using an organ intended for another, higher-priority St. Vincent patient. Staff then falsified records to cover up the situation, officials have said.
UCI in Orange shut down its liver program in November after The Times reported that 32 people awaiting livers died in 2004 and 2005 while the hospital turned down viable organs that might have saved some of them. For more than a year, the hospital had no full-time liver transplant surgeon.
John Rader and others had initially been on the liver transplant waiting list at UCI but were referred to USC by doctors.
Just four adult liver transplant centers, including USC's, are now operating in the region, which covers all of Southern California except for San Diego and Imperial counties.
Although poor survival rates are often the bane of smaller, less-experienced centers, USC is not alone among medium-to-large programs in facing troubles.
The most recent statistics show that Johns Hopkins Hospital in Baltimore, for example, had a survival rate of 76% and that St. Louis University Hospital's was 78.8%, both with nearly twice the number of deaths as expected.
USC's Selby offered two main explanations over the last two days for the low survival rate. First, he theorized that the numbers suffered because of the way the program handles liver patients who are also on kidney dialysis. Selby said other centers routinely perform combined liver-kidney transplants for these patients, who are often very sick. By contrast, USC doctors believe that most of these patients are better served by receiving only liver transplants because they say the kidneys often recover on their own afterward.
Statistics for kidney-liver transplants and liver-only transplants are tracked separately by government contractors.
Selby said he thinks the other centers' survival rates would be lower -- and comparable to his program's -- if the patients who underwent combined transplants were included with the liver-only statistics. He said he had no data to support his hypothesis, but "that's the best explanation I can come up with."
"Maybe I'm wrong, and I need to adjust my own practice," he said. "I don't think so. I'll be surprised."
Research and statistics reviewed by The Times, however, show that Selby's premise appears to be inaccurate.
A presentation given at a transplant conference last year indicated that UCLA Medical Center's one-year survival rate for the 28 patients who had kidney-liver transplants from March 2002 to August 2004 was 86%. UCLA's liver-only patients survived at about the same rate.
Data from the Scientific Registry of Transplant Recipients also showed that in 2003, the most recent year for which statistics are available, patients who underwent kidney-liver transplants had an average survival rate of 81%, still higher than USC's latest survival rate for livers only.
Responding to this information, Selby offered another reason for the poor rate: the high number of extremely ill patients overall who receive transplants at USC.
"For us, the decision is: Do we continue to do patients that are that sick?" he said. "That's the bottom line. I think it's a mistake to run away from them."
If USC is forced to focus solely on survival statistics, he said, "the overall result of that policy will be to drive down the overall number of transplants" and cause some people to die waiting.
But at least one local center that treated a much higher proportion of very sick patients than USC had far better outcomes, according to the latest statistics: Loma Linda University Medical Center's program had a survival rate of 98%.
Some USC liver patients say they have been led to believe that the program is among the best.
When Steven Stone, 55, joined the waiting list in March, he said, a social worker leading an orientation boasted about the program's outcomes. "They made it sound like it was one of the top," said Stone, of Duarte, who suffers from hepatitis C . "I said, 'It sounds good to me.' "
He wants to leave USC's program, not because of its survival rate, but to go to another region where the waiting time for a liver is not so long.
If he leaves, the hospital will still have 318 other patients on its waiting list.
Times staff writer Alan Zarembo contributed to this report.
Tracy Weber can be reached at tracy.weber@latimes.com and Charles Ornstein at charles.ornstein@latimes.com.
Back to top
FDA Panel Advises Approval of Nabi Drug
SourceURL:http://biz.yahoo.com
Nabi Pharmaceuticals Gets FDA Committee Recommendation for Hepatitis B Treatment
BOCA RATON, Fla. (AP) -- Nabi Pharmaceuticals said Thursday a U.S. Food and Drug Administration panel recommended approval of its intravenous hepatitis B treatment candidate.
The drug received a 9 to 2 affirmative vote from the blood products advisory committee to prevent recurrence of hepatitis B in patients who have received liver transplants.
If approved, the company said, the drug would be the only product in use in the United States for the protection of a transplanted liver from hepatitis B, Nabi said.
Shares of Nabi rose 16 cents, or 3.2 percent, to $5.22 in afternoon trading on the Nasdaq. The stock has traded between $3.06 and $15.71 over the past year.
Back to top
Student Interns Assist Hepatitis B Foundation
SourceURL:http://www.zwire.com
By Joan Schultz
As a high school senior, Kevin Rakszawski, first in his class, was interviewed for TV. When asked what he wanted to do in the future, he looked straight at the camera and answered, "I want to open a cancer research center."
The Archbishop Wood grad plotted his course: to pursue an Ivy League degree in bioengineering and chemistry, and eventually go on to medical school.
Following his first year at the University of Pennsylvania, Rakszawski was selected to spend the summer as a lab intern near his home in Warminster, studying viruses that can lead to an increased risk of cancer.
But Rakszawski's plans came to a screeching halt a few months later, when he faced his own head-on encounter with cancer, not as a researcher, but as a patient. Last fall, at the start of his sophomore year at Penn, the 19 year old was diagnosed with Hodgkin's disease.
He missed the fall and spring semesters to undergo treatment, but rallied to accept a second summer intern spot this year. "It's a step toward returning to normal life," he explained.
Chosen from a field of some 50 applicants, Rakszawski is one of six college students hand-picked to work side-by-side with university professors and scientists involved in the latest research designed to develop better ways to detect and treat viral diseases.
Paired one-on-one with a mentor, they put their lab skills to use, attend on-site seminars presented by top professionals, and meet weekly to discuss the latest information presented in scientific journals. At the end of the 10-week session, each student will present a summary of his or her research.
The Hepatitis B Foundation Summer Research Internship Program takes place on the campus of Delaware Valley College (DVC), where the research arm of the Hepatitis B Foundation (HBF), a national non-profit organization located in Doylestown, has partnered with a Drexel University research institute.
HBF President Dr. Timothy Block said that despite advances in providing immunizations against Hepatitis B, there are 400 million people who are not immunized, and he estimated that as many as 2 million Americans may be living with chronic Hepatitis infections that could lead to liver cancer.
"Half of them will die if we don't do something," he said.
The student internship program is part of HBF's mission to find a cure and improve the quality of life for those affected by Hepatitis B worldwide through research, education and patient advocacy.
HBF academic advisor and Drexel faculty member Dr. Pamela Norton explained that each student-mentor pair works on a focused research interest that fits into the broader scope of discovery. "It's a separate small piece of the puzzle," she said.
For example, cells which mimic the human liver are intentionally infected with the Hepatitis virus. The researchers can then measure how the chemicals react with the virus, if at all. Compounds that produce a desirable result may be identified as candidates for further study, and could eventually be developed into new drugs.
Unlike the classroom, the lab provides the students with real-life challenges, and the young researchers know that their work may lead to important discoveries that will improve the diagnosis and monitoring of disease, and maybe provide clues to develop a cure.
That's what motivates student intern Courtney Mills, a 29-year-old Doylestown mother of two, who said she has always been interested in helping people. After serving in the Navy in Kosovo and Iraq, she began her college path as a nursing student, but switched to microbiology, and is now a junior at DVC looking toward a career in anti-bioterrorism.
Mills said she is grateful for the hands-on experience. "In the classroom, you can only get so much. When you're doing it, that's when you really grasp concepts," she said.
Mills tests compounds to determine their effect on three specific proteins. Her research will give the scientific community new information about which chemicals fight disease without destroying liver cells.
She described the summer lab work as mentally challenging and draining, but at the same time pleasurable and rewarding.
And in the evening, when her 4-year-old daughter Bailey asks what Mommy did today, she answers, "I helped sick people."
The Hepatitis B Foundation is located at 700 E. Butler Ave., Doylestown, but will be moving to new facilities later this summer. For information about HBF, call 215-489-4900 or visit www.hepb.org.
Back to top
July 14th, 2006
Time to Help All Hep C Victims
http://www.thesudburystar.com
Editorial - Thursday, July 13, 2006
There is a line somewhere between legal and moral obligations that is often hard to define. Such is the case in compensating people who contracted hepatitis C from tainted-blood transfusions before 1986 and after 1990.
Reports indicate the federal government is prepared to cross what it believes is its legal safe ground onto the moral high ground by compensating people who contracted the disease in the pre-86/post-90 Timeframe.
It is a worthy step, and a significant one for people suffering from the disease.
Hepatitis C cannot be cured. It is a lifelong sentence. Symptoms range from mild discomfort to extreme fatigue to cirrhosis or even cancer. It is fatal for up to 20 per cent of those who contract the disease.
Sudbury's Ernie Zivny and Cathy Kutchaw know the symptoms well. They are suffering from cirrhosis of the liver and are in need of liver transplants. The eight extra years of waiting for compensation has been punishing, and in Zivny's case, it prompted a passionate and public fight for justice.
Compensation will not make hepatitis C victims rich. It will not cure them, but it may make dealing with the disease, which they contracted through no fault of their own, a little more comfortable. In 1998, the federal government provided $1.1 billion in compensation for people who contracted hepatitis C before 1986, when no screening tests were used in Canada (although they were available), and after 1990, when it claimed its liability ended. The years-long wait was due in part because of the potentially massive expense involved. It was first thought that up to 40,000 people might qualify for compensation, but less than 10,000 payouts have been made.
The 5,500 people in the pre-86/post-90 group have waited while those who contracted the disease the same way and suffered the same symptoms were compensated. It must have been intensely frustrating. And while they waited, many died. About 3,000 payouts have been made to estates and family members in the group that received compensation. The Hepatitis C Compassion Umbrella of Canada - a coalition of advocacy and support groups - produced a study with evidence of people losing their jobs and even being forced into bankruptcy to pay for medication.
Canada's health-care system is supposed to provide for people in need, especially those in desperate need, but the forgotten victims of hepatitis C were left behind.
A government document made public by the Canadian Press says Health Minister Tony Clement is prepared to announce a $1.1-billion compensation package later this month. No denial has been issued by Clement's office. We hope this is a sign that people like Zivny and Kutchaw will finally see the compensation they need and deserve.
Still, hepatitis C advocates point out that even with compensation, victims face a long wait because they must produce endless documentation about how they contracted the disease and the settlement must be cleared by the courts.
When Clement makes his announcement, we hope he also introduces a streamlined process for people who need help now. Waiting on legal safe ground once more would be worthless to them.
What do you think? Send us your opinion in a Letter to the Editor at 33 MacKenzie St., Sudbury, P3C 4Y1, or fax it to 674-6834 or e-mail it to letters@thesudburystar.com
Back to top
July 15th, 2006
BioMosaics Announces Products for Detection of the Glypican-3 Biomarker in Human Tissue and Serum
http://biz.yahoo.com/
BURLINGTON, Vt., July 14 /PRNewswire/ -- BioMosaics Inc., a cancer biomarker development company, announced today that it has launched its proprietary products for the identification of Glypican-3 (GPC3) in human tissues and serum. The products are based on the monoclonal antibody clone 1G12, originally developed in the laboratory of Dr. Jorge Filmus, of Sunnybrook and Women's College Health Sciences Centre and the University of Toronto, Canada. The products include the monoclonal antibody pre-diluted for immunohistochemistry (IHC) and an enzyme-linked immunosorbant assay (ELISA) for detection of GPC3 in serum. The products are sold directly by BioMosaics, and are distributed by Funakoshi Co., Ltd. in Japan and Vitro, S.A. in Europe.
GPC3 is a member of the glypican family of glycosyl phosphatidylinositol-anchored cell-surface heparan sulfate proteoglycans. The 1G12 monoclonal antibody has been used to assess GPC3 expression in malignant and non-malignant liver tissue samples and for ELISA detection of GPC3 in the serum. Capurro et al. have shown that GPC3 is expressed at the protein level by immunohistochemistry in most cases of primary liver cancer including small tumors, but is undetectable in normal liver and benign hepatic lesions [Gastroenterology, 2003; 125:89-97]. In addition, the authors found that GPC3 is significantly elevated in the serum of a large proportion of patients with Primary Liver Cancer.
Primary Liver Cancer, or Hepatocellular Carcinoma (HCC), is one of the most common and aggressive malignant tumors worldwide, causing an estimated one million deaths annually. Over 430,000 new cases of HCC are diagnosed each year. The main causative agents are hepatitis B virus (HBV), hepatitis C virus (HCV), as well as alcoholic cirrhosis and non-alcoholic steatohepatitis (NASH) which is associated with obesity and diabetes. The incidence of HCC has been steadily increasing over the past ten years and is expected to continue to rise over the next decade. The concern over the increasing significance of liver disease and associated primary liver cancer in the U.S. is reflected in the creation of a new NIH Liver Disease Research Branch charged with the implementation of an Action Plan for Liver Disease Research. It is also apparent by the introduction in the U.S. Congress of the National Hepatitis B Act, H.R. 4550 and S. 3558, which specifically identifies liver cancer as a potentially fatal disease whereby regular monitoring can lead to the early detection at a stage where cure is still possible.
"Because many liver cancer deaths may be prevented with early detection and prompt treatment, BioMosaics recognizes the importance of developing new diagnostic tests that could more effectively target a specific type of cancer in the early stages. Preliminary clinical research studies indicate that detection of GPC3 may provide good sensitivity and specificity as a tumor marker, and may ultimately contribute to fulfilling unmet medical diagnostic needs for a devastating cancer," said Ronald D. Guttmann MD, Executive Vice President of Clinical Development.
About BioMosaics
BioMosaics is a biotechnology company located in Burlington VT engaged in the development and commercialization of innovative products for the early diagnosis, prediction, and monitoring of cancer.
Contacts:
BioMosaics Inc.
Mark Allegretta PhD; m.allegretta@biomosaics.com
Ronald D. Guttmann MD; r.guttmann@biomosaics.com
Note: Statements in this news release, that are not historical facts, are "forward-looking statements" within the meaning given to that term in the Private Securities Litigation Reform Act of 1995. The Company intends that such forward-looking statements be subject to the safe harbors created thereby. Since these statements involve risks and uncertainties and are subject to change at any time, the Company's actual results could differ materially from expected results.
Source: BioMosaics Inc.
Back to top
News of Compensation Welcomed
http://www.herald.ns.ca/
By KELLY SHIERS Staff Reporter
PM expected to announce aid soon
A Lower Sackville man greeted news that federal compensation may soon be available to all victims of the tainted blood scandal with relief Wednesday.
"It’s about time, that was my first reaction," said Bruce DeVenne who has waged a long-fought battle to help others like him, who were infected with hepatitis C in the 1980s and 90s through Canada’s blood supply.
"It’s time the government started to take responsibility."
On Tuesday, The Canadian Press quoted an unnamed source who said the Conservative government will announce later this month more than $1 billion in funding for hepatitis C victims who were ineligible for compensation under an earlier $1.1-billion package.
While no amount of money can make up for their suffering, financial help for the victims will make a difference, said Mr. DeVenne.
"It’s a lot better to have money to pay bills than it is . . . to have all that pressure on you on top of your illness. You still have to live."
Although unaware of what the package may include, Mr. DeVenne said he’s known a deal has been in the works "for quite a while" to address the unfairness of the earlier deal that gave financial aid to some, and closed the door to others.
Under that earlier federal-provincial package, only people infected with the liver-attacking virus between 1986 and 1990 have been awarded money. The compensation varies on a sliding scale according to factors such as how much money the person previously earned and how sick he or she is.
Mr. DeVenne was infected by the liver-attacking virus in 1986 when he was undergoing treatment with a clotting agent for a blood disease.
Forty at that time, it was 10 years later before he learned that it wasn’t age, but hepatitis C that was draining his energy and preventing him from doing so many things, he said.
Mr. DeVenne received compensation under the initial deal, but said he’s never stopped speaking out on behalf of those who didn’t qualify for the help. He said he still finds it hard to understand how the federal Liberal government of that day could have been so "mean-spirited and cold-hearted" to leave them out.
"Believe me, that was an imaginary window," he said, even though the government initially insisted it could have done nothing to prevent infections that occurred outside that period.
"This was their attitude: We cleaned it up after the fact, and there was nothing we could have done before (1986)," he said.
But Mr. DeVenne said there is evidence that screening tests that could have prevented the infections were available before 1986. One such blood screening test was first used and documented in the 1950s, he said.
According to The Canadian Press, 10,000 people received compensation under the initial deal and another 5,500 could be eligible for compensation under the new plan.
But Mr. DeVenne said he doubts those figures. "No. 1, the farther back you go, the people are dead, either of hepatitis C or other problems," he said. "And, would you ever be able to prove it (after someone dies)?"
Mr. DeVenne said he hopes any new deal is easier to understand and requires less paperwork from the victims than the original package.
"You had to produce a whack of paperwork," he said. "They just assumed everyone lives like the government with a room full of paper shufflers keeping track of all the papers."
(kshiers@herald.ca)
‘It’s about time, that was my first reaction. It’s time the government started to take responsibility.’
Back to top
Back to News Review
|
