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Week Ending: April 2nd, 2005
Alan Franciscus
Editor-in-Chief
To download pdf version click here
This Issue:
• Safe Drug-Injection Sites Reduce Needle-Sharing, HIV Spread, Study Suggests
• Hepatitis C Antibodies May Be Slow to Appear
• State Probe Fails to Discover Source of Hepatitis C Cases Contamination
• Aethlon for HIV and Hepatitis-C Trials in India
• Heterotopic versus Orthotopic Liver Transplantation for Liver Disease
• U.S. Food and Drug Administration (FDA) Approves BARACLUDE(TM) (entecavir) for Treatment of Chronic Hepatitis B
• Hepatitis Committee Stalled, Chair Says
• Maxygen Announces Achievement of Milestone in Alliance with Roche
• New Protections Proposed for Organ Donors
• Prince to Evict Ill Mum
• County Approves Syringe Program
• Possible AIDS or Hepatitis Exposure at Pittsburgh-Area Hospital
• Smitherman Appoints Hepatitis Committee
• Methadone Programme to Halt Hepatitis C Spread
• Hepatitis C: The Silent Epidemic
March 17th, 2005
Safe Drug-Injection Sites Reduce Needle-Sharing, HIV Spread, Study Suggests
Canadian Press
Sheryl Ubelacker
Intravenous drug users who regularly use Eastside Vancouver s safe-injection site are less likely to share needles than IV drug users who do not use the site, according to a new Canadian report published in the medical journal The Lancet. Launched September 2003, InSite is a space provided for IV drug users to inject drugs. Sterile syringes and water are provided, and a nurse oversees injections to prevent overdoses and deaths and to offer substance abuse counseling and treatment referrals. The site averaged 600 visitors a day during the last 12 months.
Thomas Kerr, of the B.C. Center for Excellence in HIV/AIDS, and colleagues studied the injection habits of 431 IV drug users to see how many shared syringes. About 90 (21 percent) IV drug users reported visiting InSite for some, most or all of their injections, Kerr said. Of them, 70 percent reported being less likely to share syringes than individuals who used the facility only occasionally or not at all, said Kerr. Given the history of HIV and hepatitis C epidemics in Vancouver and in other places in Canada, this finding is significant. About 30 percent of Vancouver IV drug users have HIV/AIDS and 95 percent have hepatitis C.
The 431 participants were in a cohort the researchers have studied since 1996. What s particularly interesting is that the difference in syringe sharing really only emerged after the facility opened, said Kerr.
Safe-injection sites will not decrease needle sharing among injectors across the board, said Benedikt Fischer, senior researcher with the Toronto-based Canadian Center for Addiction and Mental Health. Studies show most IV drug users do not use such services, use them irregularly or only when it is convenient, he said. Rather, the sites can be a small but important part of reducing or stopping IV drug risk-taking, said Fischer.
An accompanying editorial acknowledged that a fraction of IV drug users access InSite. It is generally optimistic to expect a single facility to reduce overdose deaths and infections by blood-borne viruses in the community, even if the facility is shown to reduce risk behaviors in patrons, it stated.
The full report and editorial, Safer Injection Facility Use and Syringe Sharing in Injection Drug Users and Being Realistic About Benefits of Supervised Injecting Facilities, were published March 18 on the early online Lancet Web site (http://image.thelancet.com/extras/04let9110web.pdf and
http://image.thelancet.com/extras/05cmt38web.pdf, respectively).
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March 29th, 2005
Hepatitis C Antibodies May Be Slow to Appear
SourceURL:http://abcnews.go.com
Mar 29, 2005-- NEW YORK (Reuters Health) - The findings of a long-term study of injection drug users newly infected with hepatitis C virus (HCV) show that antibodies to the virus may not appear in the blood until two months after they have been infected.
These results "underscore the importance" of nucleic acid screening of blood donations to prevent HCV transmission, researchers say. The findings also reaffirm the need to follow HCV-positive injection drug users long-term to check for viral persistence.
Among 179 HCV antibody-negative injection drug users followed in the study, an "alarming" 34 percent became infected despite risk reduction counseling, Dr. Andrea L. Cox, from the Johns Hopkins Medical Institutions in Baltimore, Maryland, and colleagues report in the medical journal Clinical Infectious Diseases.
As expected, individuals with early-phase HCV infection were largely without symptoms. Virus in the bloodstream was the earliest sign of HCV infection, preceding the detection of HCV antibodies by 5 to 6 weeks, and in one case, by more than 12 months, the investigators report. However, in all other cases, HCV RNA was detected no more than 63 days before antibodies appeared.
Liver enzyme function measurements were also elevated during early-phase HCV infection, but did not correlate closely with HCV RNA levels or viral persistence. None of the infected patients developed jaundice.
In cases of viral persistence, stable blood levels of HCV RNA were noted in some individuals within 2 months after the virus was first detected in the blood, while in others, it was not apparent until more than 1 year later.
In individuals who cleared the virus from their system, HCV became persistently undetectable as early as 94 days and as late as 620 days after initial infection.
SOURCE: Clinical Infectious Diseases, April 1, 2005.
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State Probe Fails to Discover Source of Hepatitis C Cases Contamination
Associated Press
SourceURL:www.ohio.com/mld/beaconjournal/
BALTIMORE - Health officials remain mystified how a vial of testing solution became infected with the hepatitis C virus and infected 16 people, despite a five-month state probe - although a report summarizing the investigation casts suspicion on a tainted blood sample.
The vial was produced by a Timonium pharmacy run by Cardinal Health, the Dublin, Ohio-based company has said.
All 16 people who received the tracer later tested positive for hepatitis C. One recipient, a 79-year-old retired Brooklyn Park ironworker, died from the disease, his family said. The 16 people were injected with the solution Oct. 15 for routine heart-stress testing.
State epidemiologists noted in a summary of their findings released Monday that the day before the tracer was prepared, pharmacy technicians processed a blood sample that contained hepatitis B, hepatitis C and the human immunodeficiency virus. The pharmacy had been unaware that the blood was infected, the report said.
Tests by the Centers for Disease Control and Prevention in Atlanta showed that the hepatitis C virus in the blood sample was similar to the virus found in the tracer, the report said.
However, the materials used to process the tracer were discarded by the time the cases began to appear. Because of that, investigators said they could not say conclusively that the infected blood contaminated the tracer.
A decision on whether to reopen the pharmacy, which closed following the outbreak, has not been made, a company official said Monday.
State health officials said Monday that no other cases of hepatitis C are expected to be linked to the contaminated tracer.
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Aethlon for HIV and Hepatitis-C Trials in India
SourceURL:www.siliconindia.com
SAN DIEGO: Aethlon Medical, Inc. announced today that it has received Indian government nod for their upcoming HIV and Hepatitis-C trials.
Sandeep Malik, President of Qualtran, said "we are pleased to disclose that Aethlon has received letters of support from both the Government of India and the Confederation of Indian Industry (CII), which is India's premier business association." Malik continued, "Members of Parliament, Ashok Argal and Shripad Naik are personally supportive of Aethlon's HIV trials in India. They believe that if successful, Aethlon's technology could have a profound impact on the condition of HIV patients in India and around the world."
Malik concluded, "HIV infections in India could increase sharply if effective treatment strategies are not widely implemented. This could have devastating effects on the country's economic and social systems. Aethlon's Hemopurifier technology and forthcoming trials have been very well received by key opinion leaders in India."
According to the Gates Foundation, 5.1 million individuals in India were infected with HIV in 2004, a ten-fold increase over the last decade. It is projected that the number of HIV-infected citizens in India could increase to 20-25 million by 2010. Aethlon stated that site selection for the trials is under way, and that patient enrollment should begin in the coming months.
siliconindia News Bureau
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Heterotopic versus Orthotopic Liver Transplantation for Liver Disease
SourceURL:www.gastrohep.com
Heterotopic liver transplantation cannot be recommended as an alternative to orthotopic liver transplantation for any of the indications observed in a study, reports the latest issue of Liver Transplantation.
[Heterotopic liver transplantation – def: This techniques involves placing the implanted liver in the right upper quadrant and leaving the native organ in place. In the event of regeneration of the native organ, immunosuppression may be discontinued and the donor organ removed or allowed to atrophy. This technique might be preferable in patients with fulminant acute liver failure in whom regeneration of the native liver might be expected to occur – cdm.]
There are no studies comparing the long-term survival after heterotopic liver transplantation and orthotopic liver transplantation for chronic liver disease.
Dr de Rave and colleagues from the Netherlands performed heterotopic liver transplantation in 17 patients with chronic liver disease between 1986 and 1990.
In spite of theoretical advantages and favorable short-term results, the researchers abandoned heterotopic liver transplantation because of doubts about the long-term outcome and the improved results of standard orthotopic liver transplantation.
The investigators performed a case-control study of heterotopic liver transplantation versus orthotopic liver transplantation.
The study provided data from amongst the largest single-center series of heterotopic liver transplantations available.
Long-term outcome of heterotopic liver transplantation was inferior to orthotopic liver transplantation – Liver Transplantation
The investigative team considered long-term patient and graft survival as the main outcome measures.
The team corrected for known confounders and differences in baseline characteristics between heterotopic liver transplantation and orthotopic liver transplantation patients.
At 1 year, 5 of the 17 heterotopic liver transplantation patients had died, compared with 9 of the 34 orthotopic liver transplantation patients.
After the researchers corrected for confounders, the long-term risk of graft failure and of death was higher after heterotopic liver transplantation than after orthotopic liver transplantation.
In addition, the team showed that the main causes of graft loss and death at more than 1 year after heterotopic liver transplantation were de novo malignancies and a variety of biliary complications.
The research team found no significant difference between heterotopic liver transplantation and orthotopic liver transplantation in 1 year survival.
However, the long-term outcome of heterotopic liver transplantation was inferior to orthotopic liver transplantation.
Dr de Rave concludes, "Heterotopic liver transplantation cannot be recommended as an alternative to orthotopic liver transplantation for any of the indications we studied."
"We make this recommendation even though only 1 of the late deaths was definitely related to the heterotopic technique.”
Liver Transpl 2005: 11(4): 396-401
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U.S. Food and Drug Administration (FDA) Approves BARACLUDE(TM) (entecavir) for Treatment of Chronic Hepatitis B
SourceURL:http://biz.yahoo.com
PRINCETON, N.J., March 29 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY - News) announced today that the U.S. Food and Drug Administration (FDA) approved BARACLUDE(TM) (entecavir). BARACLUDE is indicated for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. BARACLUDE is an oral antiviral therapy specifically designed to block the replication of hepatitis B virus (HBV) in the body by interfering with the virus's ability to infect cells. The drug will be available in the United States as early as April 8, 2005.
"With the approval of BARACLUDE, Bristol-Myers Squibb will now be able to address another area of significant unmet medical need, building on our growing presence in fighting cancer, HIV/AIDS, schizophrenia and other diseases," said Peter R. Dolan, chairman and chief executive officer. "BARACLUDE represents the company's fourth new pharmaceutical approved in less than two and a half years, and has the potential to help many adult patients with chronic hepatitis B infection. Developed in our own laboratories, BARACLUDE is an important step forward for patients and our company, as we seek to realize our mission of extending and enhancing human life by focusing on discovering, developing and providing innovative treatments for serious diseases."
"In clinical trials, BARACLUDE demonstrated greater levels of viral suppression compared to lamivudine after 48 weeks of treatment," said Robert Gish, M.D., medical director of the California Pacific Medical Center's Liver Transplant Program. "With today's FDA approval of BARACLUDE, physicians have an important new medication to treat chronic hepatitis B."
Chronic hepatitis B infection is a potentially life-threatening disease. More than half a million people worldwide die each year from primary liver cancer, and up to 80 percent of primary liver cancers are caused by chronic hepatitis B. In the United States, more than one million people have developed chronic hepatitis B infection and more than 5,000 Americans die from hepatitis B and hepatitis B-related liver complications each year.
"Despite these alarming statistics, it is estimated that only a small percent of diagnosed chronic hepatitis B patients in the U.S. are currently receiving treatment for their disease," said Timothy Block, Ph.D., president, Hepatitis B Foundation and professor, Drexel Medical College. "The availability of BARACLUDE is an important development that provides a new option for therapy."
BARACLUDE is a nucleoside analogue with a recommended dosage of a single 0.5-milligram tablet once-daily for chronic hepatitis B patients beginning treatment for the first time (nucleoside-naïve patients), and a single 1- milligram tablet once-daily for patients experiencing resistance to lamivudine (lamivudine-refractory patients).
The BARACLUDE clinical trial program was the largest-ever conducted in chronic hepatitis B, and the first to compare two antivirals, BARACLUDE versus lamivudine (the most commonly used oral antiviral therapy for the treatment of chronic hepatitis B worldwide). In these studies after 48 weeks, BARACLUDE demonstrated statistically significant improvements compared to lamivudine in liver histology, HBV viral load reductions to undetectable levels (defined as less than 300 copies/mL) and normalization of alanine aminotransferase (ALT) levels (less than or equal to 1 times the upper limit of normal), a measure used to determine the degree of liver damage.
In these studies, BARACLUDE demonstrated comparable safety to lamivudine with a favorable resistance profile. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals. Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including BARACLUDE and lamivudine.
The most common side effects of BARACLUDE in clinical studies were headache, tiredness, dizziness, and nausea. Cross resistance has been observed among HBV nucleoside analogues. Lamivudine-resistant patients may not respond as well as nucleoside-naïve patients to BARACLUDE therapy.
Important Information About BARACLUDE(TM) (entecavir) Tablets
BARACLUDE (entecavir) is a prescription medicine for the treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. BARACLUDE does not cure HBV or stop the spread of HBV to others. People should not take BARACLUDE if they are allergic to it or any of its ingredients. BARACLUDE has not been studied in children and is not recommended for anyone less than 16 years of age.
People taking BARACLUDE should tell their healthcare provider right away if they feel very weak or tired, have unusual muscle pain, have trouble breathing, have stomach pain with nausea and vomiting, feel cold - especially in their arms and legs, feel dizzy or lightheaded, or have a fast or irregular heartbeat, as they may be signs of a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity. This may occur with liver enlargement (hepatomegaly) and fat in the liver (steatosis). People should call their healthcare provider right away if they get any of the following signs of liver problems: yellowing (jaundice) of the skin or the white part of the eyes, darkening of the urine, lightening in the color of bowel movements (stools), not feeling like eating food for several days or longer, feeling sick to the stomach (nausea), or having lower stomach pain. Lactic acidosis and hepatotoxicity have happened in some people taking medicines like BARACLUDE.
In some people, hepatitis B symptoms may get worse or become very serious when they stop taking BARACLUDE. People should not stop BARACLUDE without talking to their healthcare provider. Healthcare providers will need to follow their patients and do blood tests to check the liver when BARACLUDE is stopped. People should tell their healthcare provider if they have or develop kidney problems because their healthcare provider may want to do tests to see if a lower dose is needed.
It is not known if BARACLUDE is safe to use during pregnancy. It is not known if BARACLUDE helps to prevent a pregnant mother from passing HBV to her baby. A pregnant woman and her healthcare provider will need to decide if BARACLUDE is right for her. A woman should not breast-feed if she is taking BARACLUDE.
People should discuss with their healthcare provider all prescription and non-prescription medicines, vitamins, herbal supplements, and other health preparations they are taking or plan to take. BARACLUDE may interact with medicines that leave the body through the kidneys. The most common side effects of BARACLUDE in clinical studies were headache, tiredness, dizziness, and nausea. This list of side effects is not complete at this time because BARACLUDE is still under study. People should report any new or continuing symptom to their healthcare provider. BARACLUDE should be taken once daily on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal). To learn more about BARACLUDE and for Full Prescribing Information, including boxed WARNINGS, please visit http://www.bms.com.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb at http://www.bms.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. There can be no guarantee that BARACLUDE will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2004 and in our Quarterly Reports on Form 10-Q. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
BARACLUDE(TM) is a trademark of Bristol-Myers Squibb Company.
Full prescribing information for BARACLUDE is available at http://www.bms.com.
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March 30th, 2005
Hepatitis Committee Stalled, Chair Says
CBC News
TORONTO The chair of a committee intended to look at hepatitis C treatment in Ontario says the government has let the initiative languish for half a year.
Health Minister George Smitherman announced the committee's creation six months ago, after critics said $66 million in federal funds earmarked for hepatitis C sufferers had been absorbed into the province's general health care budget.
Since then, says chair John Plater, the committee has yet to meet even once.
"Obviously with hepatitis C, every day counts," said Plater, who also heads the group Hemophilia Ontario. "Any delay is more days of more people getting sick, and that is very unfortunate.
"Certainly I am frustrated at how long this is taking. I trust and certainly hope that this is not languishing on somebody's desk."
On Tuesday, Smitherman said he was not aware that the committee hadn't begun its work.
"This is coming slightly as news to me," he said. "I have had correspondence with John Plater on the subject of hepatitis C … but a lot of stuff goes across my desk."
A spokesperson for Smitherman later said additional members for the committee would be appointed soon.
Hepatitis C is a viral infection that attacks the liver.
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Maxygen Announces Achievement of Milestone in Alliance with Roche
SourceURL:http://biz.yahoo.com
- On Track to File IND in 2006 for an Improved Interferon Alpha to Treat Hepatitis C
REDWOOD CITY, Calif., March 30 /PRNewswire-FirstCall/ -- Maxygen, Inc. (Nasdaq: MAXY - News) announced today that it has earned a significant milestone in its collaboration with Roche to develop improved interferon alpha protein therapeutics to treat hepatitis C virus (HCV) and hepatitis B virus (HBV) infections. Maxygen and Roche are currently completing late stage preclinical studies and GMP manufacturing and are on track to file an Investigational New Drug application in preparation for Phase I clinical trials in 2006.
In May 2003, Maxygen established a $230 million strategic alliance with Roche in which Roche licensed worldwide commercialization rights to specific novel interferon product candidates developed by Maxygen for HCV and HBV. The agreement provides for Maxygen to receive development funding, milestone payments and royalties on sales of any product resulting from the collaboration. In addition, Maxygen has the option prior to initiation of Phase III clinical trials to co-develop in the United States any product to which Roche acquires a license in exchange for an increased royalty rate or profit sharing.
"Our improved version of interferon alpha is one of our leading products and Maxygen stands to receive significant value from the program," said Russell Howard, Ph.D., CEO of Maxygen. "Roche has an outstanding track record as the world leader in the treatment of hepatitis C and is the best partner to advance this program towards commercialization."
"Working with partners gives Roche access to outstanding science and innovation," said Peter Hug, Head of Roche Pharma Partnering. "Maxygen's improved version of interferon alpha is an important part of our product portfolio and contributes to Roche's strong position in virology."
The alliance also provides the companies with the option to expand the collaboration to develop other novel interferon alpha products specifically tailored for indications outside of HCV and HBV, including oncology, autoimmune diseases, inflammatory diseases, and other infectious diseases such as HIV. Maxygen retains the right to develop such products while Roche may elect to acquire worldwide license and commercialization rights to these product candidates.
The Interferon Alpha Market
Total global interferon alpha sales (including ribavirin) for all indications including hepatitis B, C and several cancers were in excess of $3 billion in 2003. Analysts estimate that sales of interferon alpha products may reach approximately $5.8 billion by 2010.
About Hepatitis C
Hepatitis C is a serious blood-born viral infection that attacks the liver, and in many patients it leads to liver disease, cirrhosis and cancer. It is the leading cause of liver transplantation. Only identified in 1989, the HCV virus has infected more than 170 million people world-wide, making it more common than the HIV virus.
About Hepatitis B
Hepatitis B is a blood-born virus that attacks the liver and is the most common serious liver infection in the world. The HBV virus is highly contagious and is relatively easy to transmit from one infected individual to another. It is 100 times more infectious than the HIV virus.
About Maxygen
Maxygen, Inc., headquartered in Redwood City, California, is focused on creating novel products using its integrated proprietary technologies for human therapeutics. Maxygen's technologies bring together advances in molecular biology and protein modification to create novel biotechnology products.
Forward-Looking Statements
This news release contains forward-looking statements about our research and business prospects, including those relating to: the timing of the filing of any IND for our interferon alpha product candidates; the timing of advancement of our alpha product candidates into clinical development; our ability to receive significant value from our interferon alpha product candidates; and forecasted worldwide sales of interferon alpha products; and the potential impact of our interferon alpha product candidates on the treatment of hepatitis C or hepatitis B virus infection. Such statements involve risks and uncertainties that may cause results to differ materially from those set forth in these statements. Among other things these risks and uncertainties include, but are not limited to: changing research and business priorities of Maxygen and/or Roche; the inherent uncertainties of clinical research and development; the ability to develop human therapeutic drugs in an increasingly competitive biotechnology industry; the uncertain timing of such development, and the ability of competitors to produce superior products. These and other risk factors are more fully discussed in our Form 10-K for the year ended December 31, 2004, including under the caption "Risk Factors," and in our other periodic SEC reports, all of which are available from Maxygen at www.maxygen.com. Maxygen disclaims any obligation to update or revise any forward-looking statement contained in this release as a result of new information or future events or developments. Maxygen is a registered trademark of Maxygen, Inc. The Maxygen logo is a trademark of Maxygen, Inc.
Source: Maxygen, Inc.
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New Protections Proposed for Organ Donors
SourceURL:http://abcnews.go.com/
By LAURA MECKLER
The Associated Press
Federal Government Proposing the First Legal Protections for Living Organ Donors
Mar. 30, 2005 - Hospitals would be required to tell prospective living organ donors of the risks of donating a kidney or a slice of liver under proposed government rules that seek to protect those donors and ensure quality care at transplant centers.
While many living donors suffer no problems, others fight pain after surgery and other complications, and a few die. Hospitals vary widely in what they tell potential donors and how they screen them.
The new rules would require hospitals to spell out the risks. Those that fail to comply could lose Medicare payments, a powerful tool aimed at ensuring that centers are providing quality care and looking out for living donors, whose numbers have soared amid an acute shortage of organs from the dead.
"That's really going to get people's attention," said Rhonda Boone of Burnsville, N.C., whose husband died in 1999 after donating a piece of liver to his half brother. "When you dip into their pocketbooks, they start paying attention."
The proposed regulation touches on a wide set of transplantation issues. Several aspects mirror guidelines already used by the United Network for Organ Sharing, a private group that runs the nation's transplant system under a government contract.
But federal regulations carry more weight. Medicare now pays for more than half of kidney transplants done each year and a smaller portion of other transplants. Beyond that, if Medicare drops a program, private insurance companies sometimes follow suit.
The proposal, which would subject transplant centers to more scrutiny, is getting a mixed reaction. Some say the government has no business trying to judge medical practice; others contend the oversight is overdue.
The Department of Health and Human Services is seeking comments on the regulations, published last month. Officials expect it will be two years before they are put in place.
For hospitals, the biggest change would require organ donor programs to be certified by the government every three years.
In doing so, HHS officials would compare the number of transplant recipients who survive one year and the number of transplanted organs that last a year with the numbers expected given various medical factors such as how sick the patient was before the transplant. If statistical tests show the difference was not just due to chance, the hospital could lose Medicare reimbursements.
Using the proposed criteria, 10 percent of 541 existing adult heart, kidney, liver and lung transplant programs would fail the test, as would 2 percent of 309 pediatric transplant centers, the government said. It did not name the centers.
Programs that fail to meet the standard would be subject to a more extensive review and would be given the opportunity to improve before Medicare cut them off, said Marcia Newton, a senior policy analyst at the Center for Medicare and Medicaid Services.
"The goal is to assist the transplant center in determining where the problem is and what needs to be done," she said.
Still, some doctors object to the government stepping in to regulate a field that has been self-policed. The last time HHS tried to regulate transplantation specifically, how organs were distributed it led to a yearslong battle.
Dr. Richard Freeman, a liver surgeon at Tufts University, noted the proposed standards were developed by the private transplant network, which does its own, more collegial review of transplant programs. He fears the government will automatically conclude there are problems when a detailed inquiry might find none.
"Maybe the quality is just fine," he said.
Boone, whose husband died after donating part of his liver, rejects that argument, saying, "Any transplant center of excellence that's doing a good job will not be afraid of accountability."
Many say federal oversight is particularly essential to protect living organ donors, who agree to undergo a procedure that has risks without medical rewards.
Kidney and sometimes liver transplant patients are now routinely urged by their physicians to seek living donors after being told it will take years before they reach the top of the waiting list, which now numbers more than 87,000 for all organs. Relatives and friends could feel pressured to say yes.
Last year, there were nearly 7,000 living organ donors more than double the number a decade ago. Most gave a kidney; about 300 gave a liver lobe, and 28 donated a piece of lung.
The proposed Medicare rules would include requirements that transplant centers "fully inform" potential donors about their right to opt out at any point, as well as the "medical or psychosocial risks to the donor."
Additionally, centers would have to tell would-be donors that future health problems related to the donation may not be covered by their insurance and that their ability to obtain health, disability or life insurance may be affected.
Even so, that wouldn't guarantee that potential donors would know the risks, because little national data exist on long-term medical effects on living donors. An HHS advisory committee has recommended a long-term registry of donor health and welfare, but it has not been implemented.
That committee also recommended that an independent advocate be established at each transplant center to look out for donors' interests without regard to the would-be recipient's health or the surgeons' interests.
It's essential, argued Vickie Hurewitz, whose husband Mike died in New York City after giving a piece of liver to his brother.
"An advocate must follow the donor from the time he walks in the door until discharge," she said. "Somebody has to protect the donor from himself."
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Prince to Evict Ill Mum
By Geoffrey Lakeman
http://www.mirror.co.uk/
PRINCE Charles is threatening to evict a seriously ill single mum-of-five after increasing her rent by 66 per cent.
Julie May, 50, who has hepatitis C, was paying £450-a-month rent.
But the prince's Duchy of Cornwall Estate - which earns £12million a year - put it up to £750 in February 2004 and she fell behind with payments.
Mrs May now claims all but £960 of her £4,000 rent arrears for the cottage in St Columb Minor, near Newquay, have been paid by Restormel council.
But Duchy Estate officials have instructed a solicitor to "proceed with possession".
Mrs May, who lives on £180-a-week benefits, said: "I have laid in bed and cried for days on end. The Duchy is throwing us out on the street."
An estate spokesman said it was a "private" and refused to comment.
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County Approves Syringe Program
Oakland Tribune
Rebecca Vesely
On Tuesday, the Alameda County Board of Supervisors unanimously approved a resolution allowing pharmacists to sell or give away 10 syringes at any one time without a prescription to anyone 18 or older.
The resolution stems from the September passage of SB1159, which approved over-the-counter sales of syringes in California. The law aims to stymie the spread of blood-borne diseases like HIV and hepatitis C among injection drug users. "When injection drug users are unable to buy clean syringes, they resort to sharing dirty ones," said Dr. Anthony Iton, Alameda County's public health officer. "This law will prevent many cases of HIV and hepatitis C infection and ultimately will save many lives."
Under the new program, county pharmacists must register with the local health department and must certify that they will provide syringe purchasers with written or verbal information about drug treatment programs and proper disposal of used needles. The Alameda County Office on AIDS Administration will maintain a list of participating pharmacies and provide the pharmacies with information to distribute. Board President Keith Carson said the county will work with pharmacies to ensure proper disposal of needles as is required under the law, which makes it a crime to improperly dispose of used needles in certain public areas.
Alameda is one of four counties statewide to adopt resolutions implementing SB1159. Iton said about a quarter of all AIDS cases in Alameda are linked to sharing dirty syringes. The county reports that of its 36,000 hepatitis C-infected residents, at least 26,000 were exposed through needle sharing for injection drug use.
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March 31st, 2005
Possible AIDS or Hepatitis Exposure at Pittsburgh-Area Hospital
SourceURL:http://www.kron4.com
MONROEVILLE, Pa. A hospital outside Pittsburgh is tracking down some 200 people who recently got colonoscopies.
Forbes Regional Hospital in Monroeville, Pennsylvania, says the patients may have been exposed to hepatitis or AIDS because the instruments used may not have been fully disinfected.
The patients involved got colonoscopies between October 28th and February 26th. A hospital spokesman says about 70 have called in so far.
They'll be given free H-I-V and hepatitis screenings now, and again in six months. Hospital officials say the chances they became infected with anything are low.
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Smitherman Appoints Hepatitis Committee
SourceURL:http://ottawa.cbc.ca
CBC News
TORONTO -- Health Minister George Smitherman says he has now kept a months-old promise to set up a task force on the treatment and prevention of hepatitis C.
On Wednesday, CBC News reported that half a year had passed with no action since Smitherman promised to create the committee.
FROM MARCH 30, 2005: Hepatitis committee stalled, chair says
Committee chair John Plater said there had been no meetings, and that he feared the matter was "languishing on somebody's desk."
Smitherman said the appointments were made Tuesday evening, after CBC News questioned him about the matter.
"It has taken longer than I might have preferred," Smitherman said.
"Those names will be public within the next few days, and I fully expect that, under John Plater's leadership, a committee meeting will be able to take place in four [weeks], six weeks at the outside."
Smitherman announced the committee's creation last fall, after critics said $66 million in federal funds earmarked for hepatitis-C sufferers had been absorbed into the province's general health-care budget.
Hepatitis C is a viral infection that attacks the liver.
Thousands of Canadians were infected with hepatitis and HIV, the virus that causes AIDS, when tainted blood was distributed throughout the country in the 1980s.
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April 1st, 2005
Methadone Programme to Halt Hepatitis C Spread
SourceURL:http://www.nzherald.co.nz
Methadone maintenance therapy for injecting drug users saves lives and is a cost-effective way of treating New Zealand's growing and expensive hepatitis C health problem, researchers say.
Policies aimed at controlling the spread of the debilitating hepatitis C virus were needed urgently, lead investigator Dr Ian Sheerin from Otago University's Christchurch School of Medicine and Health Sciences said in a statement today.
Of an estimated 19,000 injecting drug users in the country, 84 per cent had hepatitis C, but few of whom were receiving treatment for the virus, the statement said.
Nationally 30,000 people were estimated to have the virus, a figure expected to double by 2010.
Dr Sheerin, from the school's department of public health and general practice, said if the virus spread it would have rapidly escalating health and social welfare costs as sufferers became more debilitated, needed constant health care, and their livers failed.
Those costs had been estimated to rise to between $166 million and $400 million over the next 30 years unless adequate treatment and disease control was provided, he said.
It made more sense to invest in hepatitis C treatment at an early stage, than wait until people needed a liver transplant.
"There's a tendency in New Zealand to see this as just a drug users' problem, therefore why worry. That's ignoring the fact that hepatitis C is a growing and expensive health issue, which won't go away," Dr Sheerin said.
"The existence of a large pool of untreated infectious disease is a potential threat to everyone."
Because the hepatitis C virus was slow in its progression, there had been limited recognition of it as a public health issue and New Zealand was losing ground by about 1300 new infections every year.
The Christchurch school's research found that excess mortality from drug overdoses was reduced by 75 per cent among people on methadone maintenance.
Ninety-eight per cent of the participants stopped injecting drugs, reported large improvements in their health and also reductions in drug-related crime, the statement said.
There was evidence large numbers of drug users wanted treatment for hepatitis C, but did not get it. Meanwhile, there were also long waiting lists for methadone maintenance treatment.
Dr Sheerin said policies aimed at controlling the spread of the hepatitis C virus should include needle exchanges, education about risky behaviours, blood awareness, access to drug and alcohol services, as well as hepatitis C treatment.
"The size of the health problem is not being matched by government investment in communicable disease control. The policy documents say the right things, but the commitment has not been made to address the issue adequately," he said.
The Government had taken an important step in 2004 when it funded combination medication for hepatitis C, which had been found to be effective, curing 80 per cent of cases of some types of the virus.
Although hepatitis C medication was expensive, the courses were short and would prevent 39 per cent of future health costs.
- NZPA
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Hepatitis C: The Silent Epidemic
SourceURL:http://www.roanoke.com
Ricardo Valdivieso and Yolanda Puyana
ROANOKE.COM COLUMNISTS
Two weeks ago I wrote about the HIV/AIDS epidemic, but the fact is that the story is not complete if we do not talk about hepatitis C.
Hepatitis C is an inflammation of the liver that can result in cirrhosis or cancer. It is transmitted mainly by contact with contaminated blood.
People at high risk include anyone who received a blood transfusion or organ transplant before July 1992. Others at risk include those who have injected illegal drugs, even single-time users.
Recent statistics estimate that about 70 million people worldwide are infected. The same statistics estimate that there are 8,000 deaths annually in the United States as a result of hepatitis C.
The most serious problem created by the hepatitis C epidemic, according to the Centers for Disease Control and Prevention is that the majority of chronically infected persons do not know they are infected because the symptoms are not visible. They are carriers and contagious up to two decades after the initial infection.
Debbie Delgado, founder and director of LOLA (Latin Organization of Liver Awareness), an organization dedicated to inform and educate the public about liver disease and its treatment, has indicated that hepatitis C is the third cause of death among Hispanic Americans in the United States.
It is estimated that one of every 50 persons of Hispanic American origin is infected.
Recently the agency that regulates food and drugs in the United States – the FDA – approved a treatment that combines a series of medicines in one injection and is three times more effective than the previous single drug treatment.
If you think you have been exposed to hepatitis C, visit a doctor or call LOLA toll free at (888) 367-5652. Bilingual assistance is available.
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