LiverHope
VOLUME 6, ISSUE 2 February 2004
LiverHope
VOLUME 6, ISSUE 2 February 2004
Are you newly diagnosed or do you want more
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February 15th, 2003 -
In This Issue
Wisc.
Senate Approves Tax Deduction for Organ Donors
MELD
Scores and Liver Transplants
FDA
Approves Roche’s Pegasys Pre-filled Syringes
"Hep
C Aware" -The Internet Telethon
Actimmune
for Advanced Liver Cirrhosis Fails in Study
Putting
More Life In Your Living
It is with great regret that we pass along to you the news that our friend, Richard (Richie) Dobey, died Christmas Eve, 12-24-03, after having been in a coma for about a week. He’d been in and out of the hospital and nursing homes for some time due to the many complications from his hepatitis C, cirrhosis and end-stage liver failure. He was only 36 years old. One of his friends said it best, “He was a big, goodhearted, loveable kid who battled his own demons, yet tried his best to give friendship and love to all who knew him.” He will be missed by many.
Wisconsin Senate Approves Tax Deduction for Organ Donors
By
Jo Napolitano
New York Times
CHICAGO (January 23, 2004) — The Wisconsin State Senate passed a bill on Thursday calling for a state income tax deduction of up to $10,000 to cover expenses for residents who donate their organs. Supporters say it is the most ambitious move by a state government to increase transplants.
The bill, which was overwhelmingly approved by the State Assembly in November, passed in the Senate by a vote of 28 to 2 and will now go to Gov. James E. Doyle, a Democrat, who has said he will sign it into law.
"I'm very supportive of it," Mr. Doyle said. "This is a big issue in Wisconsin."
The law will allow donors to deduct from their taxable income the costs they incur from donating all or part of a liver, pancreas, kidney, intestine, lung or bone marrow. Eligible expenses include travel, lodging and lost wages, and the maximum deduction is $10,000. The law is expected to cost the state about $115,000 annually, the bill's sponsors say.
Critics of the legislation question whether such a tax credit would violate the 20-year-old National Organ Transplant Act. The federal law bans the purchase or sale of human organs, an industry that spawned organ brokers overseas but that is a crime in the United States punishable by a $50,000 fine and a five-year prison term.
"When you get as high as $10,000 you start to wonder what that means to people and if there is some coercion that goes on with that," said Howard M. Nathan, president and chief executive of the Gift of Life Donor Program, a nonprofit agency in Philadelphia.
But State Representative Steve Wieckert, a Republican from Appleton who sponsored the bill, said it was not intended to offer cash for human organs. Instead, the tax credit would help remove an obstacle that prevents people from donating, he said.
"We want to be very careful that we are not getting into the business of selling organs but to encourage organ donation," Mr. Wieckert said. "No one, rich or poor, would receive any additional money for donating. All they would do is lose less money."
Mr. Wieckert said that the federal ban on payment for organs excludes costs associated with travel, lodging and lost wages, so the law would be within federal guidelines.
One Wisconsin organ donor
says he knows all too well the need for financial reimbursement for the people
who undergo such procedures. The man, Marty Monroe, donated a kidney to his
son, Cody, who was 5 in December 2001 when he suffered kidney failure. Mr.
Monroe, who is married with three children, was out of work for three months
and lost $6,000 in wages after the surgery.
"These days, if you miss a payment on your bills, they call the collection agency and they can repossess your house," said Mr. Monroe, a truck driver who lobbied for passage of the bill. "I think the law is fine. They're not giving money for organs, but helping people survive after giving the gift of life."
State Representative Bob Ziegelbauer, a Democrat from Manitowoc, northeast of Madison, was the only Assembly member to vote against the bill, saying it would needlessly complicate the tax code for a marginal deduction at a time when his state faces a fiscal crisis.
"Why should the government be in the business of handing out rewards to people when they do good things?" he said. "I think we need to keep the tax code simple and understandable."
Wisconsin is not the first state to try to create incentives to increase organ donations. Indiana is considering nearly identical legislation.
The Kansas Legislature
considered approving a tax break for blood and organ donation in 2000, but the
bill stalled in committee after the state's attorney general wrote in an
opinion that federal law prohibited the proposal.
MELD Scores and Liver Transplants
Three articles in the January 2004 issue of Liver Transplantation discuss changes in liver transplant outcomes since the United Network for Organ Sharing (UNOS) implemented a new system of donor liver allocation in early 2002. Under the new system, each liver transplant candidate receives a MELD (Model for End Stage Liver Disease) score based on three laboratory values: bilirubin, prothrombin time/INR (a blood clotting test), and creatinine (an indicator of kidney function). Patients with the highest scores are given priority to receive cadaver livers as they become available. The MELD system replaces an older method that took into account time spent on a waiting list; now, waiting time is only considered when patients have the same MELD score. Subjective factors (such as a doctor’s assessment of symptoms) are no longer considered, and the new system reduces the incentive for doctors to place patients on the list before they have severe liver disease.
Richard Freeman, MD, and colleagues — members of the UNOS/OPTN Liver and Intestine Transplantation Committee — reported results from the first year of the new allocation method. Since the MELD system was implemented on February 27, 2002, new liver transplant list registrations have fallen by 12%. The rate of death while on the list decreased by 3.5%, and the transplantation rate increased by 10.2%. The decrease in mortality and increase in transplantation were evenly distributed across all demographic groups. Although sicker individuals received more transplants, early patient and graft survival remained unchanged. “The new system has been associated with reduced registrations and improved transplantation rates without increased mortality rates for individual groups of waiting candidates or changes in early transplant survival rates,” the authors concluded.
In the same issue,
Pratima Sharma, MD, from the Mayo Clinic and colleagues reported on the impact
of the MELD system on liver transplants due to hepatocellular carcinoma (HCC).
A review of the UNOS database revealed that the transplantation rate for
patients with HCC tripled after the implementation of the new system. Waiting
time decreased from 2.28 years to about 0.69 years, with 87% of HCC patients
receiving a new liver within three months. The 5-month survival rate of
patients on the waiting list increased from about 90% to more than 95%. Since
MELD was implemented, “significantly higher proportions of candidates listed
with the diagnosis of HCC are receiving a deceased donor liver transplant,”
said Dr. Sharma. Paul H. Hayashi, MD, and colleagues from the University of
Colorado Health Sciences Center reported that the proportion of patients at
their center receiving a liver transplant due to HCC increased from 12% to 35%.
But they concluded that “a small but significant portion” of cadaver livers
went to patients misdiagnosed with HCC (that is, after transplantation, no
cancer was found in the old liver)—organs that otherwise could have gone to
patients with more serious liver disease related to
other causes. Due to concerns that the new system might be giving people with
HCC an unfair advantage at the expense of individuals with liver damage from
other causes, UNOS slightly modified the MELD policy in January 2003; the
effects of these changes are not yet known.
Finally,
because the MELD system allocates available livers to the sickest patients
first, there has been some concern that donated livers might be given to
patients
who
are too ill to survive a transplant. In the January 15, 2004 issue of Transplantation,
Niraj Desai, MD, of Washington University School of Medicine and colleagues
reported that while the MELD score accurately predicts pre-transplant
mortality, it is a poor predictor of post-transplant survival. The authors
determined a set of four variables — age, use of mechanical ventilation, kidney
dialysis, and need for re-transplantation — that they suggest might be used “to
identify futile cases in which expected outcome is too poor to justify
transplantation.”
The February 2004 issue of the Reader’s Digest has a cover story titled ”10 Diseases Doctors Miss.” Hepatitis C is listed as number one. Hopefully this article will prompt many, many more requests for the Hepatitis C antibody test to be done resulting in patients being accurately diagnosed.
Friday, January 09, 2004 - Roche announced today that the U.S. Food and Drug Administration (FDA) has approved pre-filled syringes of Pegasys (Peginterferon alfa-2a) which will be more convenient for patients to use during treatment for chronic hepatitis C.
Pegasys, a pegylated alpha interferon, and Copegus (ribavirin, USP) were approved by the FDA in December 2002 for use in combination for the treatment of adults with chronic hepatitis C who have compensated liver disease and have not previously been treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis.
Roche expects Pegasys pre-filled syringes to be available in pharmacies by the end of the month. Pre-filled syringes will be packaged four per box. Pegasys is currently available in vials as a pre-mixed solution.
Pegasys is dosed at 180mcg as a subcutaneous injection taken once a week. Copegus is available as a 200mg tablet, and is administered orally two times a day as a split dose.
"Taking a medication by self-injection can be challenging for some people," said Dr. David Bernstein, Director of Hepatology, North Shore University Hospital. "Reducing the number of steps involved can make the process less intimidating for patients and reduce the risk of errors."
The introduction of pre-filled syringes is yet another way in which Roche is working to add value to the management of hepatitis C, including:
1. developing approaches to reduce the duration of treatment with Pegasys and Copegus and the dose of Copegus therapy for certain patients
2. formulating Pegasys as a pre-mixed solution requiring no reconstitution prior to self-injection
Hepatitis C is a blood-borne infectious disease of the liver and the leading cause of cirrhosis and liver cancer and the number one reason for liver transplants in the U.S.
NYC Hospital
Resumes Liver Transplants
January 15,
2004
NEW YORK (AP) - The Mount Sinai Hospital - one of the world's top live-donor liver transplant centers - has resumed transplants between adults two years after the death of a man who gave part of his liver to his brother, a hospital spokesman said Thursday.
This week, a 66-year-old woman received part of her daughter's liver.
The patient, Therese Lee Mallon of Mahopac, N.Y., was battling liver cancer and was in urgent need of a transplant, which was performed Wednesday. Since no cadaver donor was immediately available, her 41-year-old daughter, Rose Anne Mallon, offered part of her organ.
Mount Sinai had voluntarily suspended its adult-to-adult liver donation program in January 2002, after the death of Michael Hurewitz, a 57-year-old Albany Times-Union reporter who succumbed to a post-surgical infection. He was the first living liver donor to die at the hospital.
State health officials said Hurewitz had received "woefully inadequate" care. The state found other lapses, including a first-year surgical resident left alone with 34 patients in the transplant unit, and fined Mount Sinai the maximum $48,000 on 18 violations.
While state health officials reviewed the case and other adult-to-adult transplant procedures, the hospital continued its adult-to-child live-donor liver transplants.
Bill Van Slyke, a spokesman for the state Department of Health, said Thursday that the hospital has corrected the problems. "We have confidence that they're providing excellent care," he said.
Since 1988, Mount Sinai physicians have performed more than 2,300 liver transplants, including more than 180 involving living donors.
"Hep C Aware" -The Internet Telethon
Saturday,
Feb 7, 2004
Noon-
Midnight PST
www.HepCCoalition.com
Kelly Z, the National Spokesperson for the Hepatitis C Coalition and comedian Courtney Cronin will host a live 12-hour telethon of music and comedy on Saturday, Feb. 7, 2004 from Noon-Midnight PST on www.HepCCoalition.com to raise awareness about Hepatitis C and to raise funds for The Hepatitis C Caring Ambassadors Program. This marathon concert event will feature live performances, music videos and comedy from a wide range of stellar performers and entertainers. Hepatitis C infects 1 in 50 American adults, is four times more prevalent than HIV, and is the #1 reason for liver transplants in the U.S. Deaths from the disease are projected to triple in the next 10-15 years. For more info visit www.HepCCoalition.com
Contact: Kelly Z
(818)769-2701
HepatitisCAware@aol.com
Actimmune for Advanced Liver Cirrhosis Fails in Phase II Study
News Release – 1/21/04 -InterMune announced this week that a Phase II clinical trial of Actimmune (interferon gamma) for treatment of advanced liver fibrosis, or cirrhosis had failed to meet a primary endpoint.
The study evaluated the drug for use in patients with chronic hepatitis C with cirrhosis who had failed standard treatment (interferon alfa plus ribavirin).
The objectives of the study were to evaluate safety and the ability of Actimmune treatment to reverse fibrosis in chronic hepatitis C patients with advanced liver disease when administered for 48 weeks. The primary endpoint of the study, reversal of liver fibrosis as determined by the Ishak histology scoring system, was not met.
Interferon gamma was generally well tolerated and side effects were consistent with those seen in previous experiences.
“We have learned from this study that interferon gamma-1b is generally well tolerated in this patient population," said James Pennington, M.D., Executive Vice President of Medical and Scientific Affairs at InterMune. "We believe that earlier intervention in milder patients over a longer period of time may be necessary to demonstrate efficacy."
Actimmune (Interferon gamma 1b) is a naturally occurring protein that stimulates the immune system.
Source: InterMune, Inc. www.intermune.com.
Putting More Life In Your Living
By Steve Goodier C 2003
A mother eagerly opened a thick envelope from her
son, who had recently
moved to a small town in rural Texas. He wrote:
"Hi, Mom,
Just wanted to let you know everything that's been
going on around here.”
The next four pages were blank.
Of course, he'll likely change his attitude about
his new home once he begins making friend unless he learns a negative
outlook so well that
he keeps it on into adulthood. For many unhappy people, their despondency springs from no more
than the fact that they have simply learned apathy and unlearned enthusiasm.
Have you heard of the four W's? These are words
most of us use. Some of these words we use often; some not often enough.
Here they are:
1.
Wait.
We use this word when we want to hold off on something new or risky or unusual.
2.
Why
not? We say this when we're ready to move ahead.
3.
Wow.
Unlike "wait" and "why not," this word is used far
too infrequently.
It denotes a deep sense of awe, an emotion linked to gratitude and wonder.
4.
Whoopee!
Used rarely, "whoopee" expresses unrestrained joy and
enthusiasm. Those adults
who have learned to say "Whoopee!" know something about great living.
When they retire at the end of the day, they often feel as if that day were lived to its fullness.
We can be so busy living life that we never put
life in our living.
Note how often you use these four words (or words like them): "Wait," "Why not?", "Wow" and "Whoopee!" As you put more life in your living, you'll find that you are living life more fully!
Co-Facilitators
Email: info@liverhope.com
Fax: (763) 566-0589
Website: www.liverhope.com
Helen: (952) 933-0932 – helen@liverhope.com
Pat:
(763) 566-3839 – pat@liverhope.com
[1]
John Lake, M.D., is Medical
Director of the Liver Transplant Program at Fairview-University Medical Center
in Minneapolis, MN. Dr. Lake has served as the Medical/Scientific Organ Representative
of the UNOS Board Directors, as well as a member of the Liver Review Board and
the Liver Disease Severity Scale and Liver/Intestine Transplantation
Committees. Outside of UNOS, Dr. Lake
serves on the ASTP Education Committee and the Board of Directors to the
Minnesota Chapter of the American Liver Foundation. He has served on numerous community and national committees. He is a member of numerous societies, including
the American Federation for Clinical Research and International Liver Transplantation
Society. He was named “One of the Best
Doctors in the U.S.” in 1996 by Modern Medicine Magazine and won ASTP’s Young
Investigator Awards in 1997. He has
published numerous scientific papers in professional journals. He earned his M.D. degree from the
University of Minnesota Medical School.