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March 22nd, 2007
Indian clinics uncover high rate of hepatitis C
http://www.billingsgazette.net
By Diane Cochran
Of the Gazette Staff
An epidemiological study conducted at two Indian Health Service clinics in Montana uncovered a hepatitis C infection rate that is six times higher than is found in the general population.
The finding surprised tribal and state health officials, who responded by creating an educational brochure that targets young American Indians.
The 2005-06 study, authored by IHS epidemiologist Christine Dubray, revealed a 6 percent hepatitis C infection rate among women who went to the clinics for prenatal care.
Only about 1 percent of people in the U.S. population has hepatitis C, Dubray said. "We have an unexpected number of young women with hepatitis C infection," she said. "In the general American population, the prevalence of hepatitis C is much lower in young women."
Hepatitis C is a virus that can lead to serious liver damage and death. It is spread through contact with infected blood and cannot be cured.
"There is a treatment for Hepatitis C," said Dubray, who is based in Albuquerque, N.M. "It doesn't work for everyone, but there is a treatment. It's not hopeless."
During the 13-month period of Dubray's study, 205 women were screened for the virus, and 13 tested positive.
It is thought that the women, who were probably exposed to the virus as teenagers or very young adults, contracted it through intravenous drug use.
The study did not examine what kind of drugs might have been used.
Although the study examined only American Indian women, it is likely that other groups of young Montanans would also have higher than expected hepatitis C infection rates because of drug use, said Laura Baus, hepatitis C coordinator for the state Department of Public Health and Human Services.
"Whether American Indian or Caucasian, there's no division there," Baus said of hepatitis C infection among the state's youth. "We're seeing it in both populations."
Nationwide, the average age at a hepatitis C diagnosis ranges from 40 to 59, Baus said.
"What we're seeing in Montana is we're averaging 15 to 24," she said. "We're seeing them younger."
About 9,000 Montanans are known to have hepatitis C, which the state tracks as a reportable disease. Officials think another 5,000 people are infected but don't know it, Baus said.
Symptoms often do not develop until years, and sometimes decades, after infection occurs.
Between 75 percent and 85 percent of people who are exposed to the virus become what is called chronically infected, according to the Centers for Disease Control and Infection. The rest "clear" the virus.
About 3.2 million Americans are chronically infected with Hepatitis C. Intravenous drug use is the most common infection source.
Tribal and state health officials used Dubray's study for the basis of an educational brochure that will be distributed via Montana IHS clinics and other outlets on the state's reservations.
"After Christine's work, it was obvious we needed to do a public-health initiative," said Jennifer Giroux, an epidemiologist with the Rocky Mountain Tribal Epidemiology Center in Billings.
"If we don't get the information out there to the public, what good is having looked?" Giroux asked.
The brochure, an educational medium favored by CDC, was designed specifically for American Indian consumers, Baus said.
"One size doesn't fit all," she said. "You have to gear it toward your audience."
Contact Diane Cochran at dcochran@billingsgazette.com or 657-1287.
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March 23rd, 2007
Widow vows to fight soldier's last battle
http://www.recordonline.com
By Heather Yakin
Times Herald-Record
Continues struggle for military benefits
At her Middletown home, Lydia Colon displays photos of her late husband, Oscar Colon, and the flag that was used at his funeral. Before he died from liver cancer, he fought for years to try to get a disability pension from the VA.
Oscar Colon served his country proudly. He spent two years in the Army, four in the Army Reserve and 19 in the Army National Guard. He volunteered for Operation Desert Shield, spending five months in Saudi Arabia and other parts of the southwest Asia theater.
His wife, Lydia Colon, believes his time in the Persian Gulf made him sick. His well-documented illness led him into a decade-long fight to collect some kind of military pension. But Oscar Colon, 64, a Middletown resident, died from liver cancer in January, still waiting for progress in his latest attempt to get a service-connected disability pension.
"He made me promise him that I would continue his fight," Lydia Colon says.
Waiting for a military disability ruling is the norm, say reports from the federal General Accounting Office. In 2007, Veterans Affairs had 392,000 claims pending, of which 101,000 had been waiting for six months or longer.
But Colon's case is also colored by the nature of his illness, and the tangles of military bureaucracy.
Certain things are clear
At some time in Colon's life, he contracted Hepatitis C. He developed cirrhosis of the liver in the 1990s, and was diagnosed in 2006 with liver cancer. About 20 percent of people with chronic Hepatitis C will develop cirrhosis after 10 to 20 years, and a small number will go on to develop liver cancer, according to the National Digestive Diseases Information Clearinghouse.
Oscar Colon met Lydia in 1994. They married in 1999. He raised six sons, and she helped raise his four youngest. Despite his illness, they had 14 good years together.
"He was my buddy, my best friend," Lydia Colon says. "We didn't have a lot, but we loved each other very much."
She has an album filled with his photos. He smiles in the desert of Southwest Asia. He smiles from photos where his six sons surround him, with grandchildren, with her.
"It's all I have now," she says, "is memories."
"I am in poor condition"
Throughout Colon's military record, he is described by superior officers as eager to learn, capable and fit. He reached the rank of staff sergeant.
Outside the military, he worked as a carpet installer, carpenter and truck driver. In 1990, Lydia Colon says, he volunteered for Operation Desert Shield.
The soldiers got medical screenings before deployment. Colon's military file shows that his liver enzymes were significantly elevated — a sign of illness — just before he was sent to Saudi Arabia in November 1990. Lydia Colon says doctors didn't tell him that. He served his country in the Saudi theater until late April 1991.
Immediately after his return, records show, he reported joint pain, shortness of breath, chest pain, leg cramps, back pain, sleeping problems and trouble with a recurring rash.
"I am," he wrote at the top of the military health form, "in poor condition." To warrant service-connected disability payments, an illness must be caused or aggravated by military service. Colon's statements on this paperwork could be crucial to the case.
The source of exposure is unknown in about 30 percent of chronic Hepatitis C cases, according to the National Digestive Diseases Information Clearinghouse.
A battle waged for benefits
By 1993, his health failing, Colon left active duty. In 1998, he left military service completely. Times were tough, says Oscar Colon Jr., the youngest of his sons. On top of his illness, the elder Colon was hurt in 1993 while working for the state transportation department. He couldn't work much after that. At times, the family relied on government assistance, his son says.
Army letters show Colon's liver enzymes remained elevated after his return from the desert. Veterans Affairs doctors did a liver scan in July 1991, diagnosing cirrhosis with "mild to moderate liver dysfunction." Hepatitis C was only identified in 1989; the test to detect it became available in 1992. The VA diagnosed Colon in 1994.
Lydia Colon says her husband's health worsened over the years. He was exhausted, forgetful, in pain, depressed.
But when he left the Army National Guard in 1998, he didn't ask for a medical discharge. Instead, Colon campaigned to collect a military retirement pension, helped by the Orange County Veterans Service Agency. The battle helped: He was credited with a total of 19 years, 41 days of service — about 11 months shy of retirement eligibility.
To earn a pension, a guardsman needs 20 years of service, at least eight of them in the reserves. Each year, he must earn 50 points — essentially, days of active service — for a year to count. In 1979 to 1980, Colon fell short, with 47 points.
"Normally, before you retire, they advise you to do a records reconciliation, to make sure you have what you think you have," says Eric Durr of the state Division of Military and Naval Affairs. "If you have 20 years, you get a letter from the military."
Colon never got that letter.
With that door closed, Colon sought a service connection for what he believed was Gulf War Syndrome, to qualify for a disability pension. Many of his symptoms match those described for the poorly understood syndrome, but they also fit chronic Hepatitis C.
Colon got help from the office of Rep. Maurice Hinchey, D-Hurley. It's a cumbersome process, says Hinchey spokesman Jeff Lieberson, and woeful VA understaffing adds to the delays.
"The VA is consistently underfunded by President Bush," Lieberson said, calling past Bush budget cuts for the VA system "entirely inappropriate and disgraceful." Still, Colon met with denials.
In April 2006, Colon was diagnosed with liver cancer. In May 2007, the military agreed to hear his appeal, to reconsider whether his liver disease and the insomnia and memory problems it may have caused were service-connected. Oscar Colon was waiting for more information from the military when he died Jan. 20.
That ended his appeal. Case closed.
The fight rages on
But this fight isn't over. Lydia Colon is working with Anthony Zippo at the Orange County Veterans Service Agency, and with Hinchey's office. She'll likely have to file anew, for survivor's benefits.
"I don't think she's going to lose it," Zippo said. "I personally believe she has a case."
A week before Colon died, he asked his wife to make his favorite meal, rice and beans. They laughed and talked. He got up and danced in the living room.
"And then he went back to bed, and that was it," she said. "He never got up again."
A book Hospice gave her says that people with terminal illnesses can get a burst of energy, near the end.
"That's their way of saying goodbye," Lydia Colon says.
Even to the end, he was a soldier. He told her that if he could, he would go back and fight for his country.
Now it's her turn.
"I'm going to fight this to the end," Lydia Colon says. "This is going to be my mission now."
hyakin@th-record.com
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Live-donor procedures performed early raise risk factor
http://www.pittsburghlive.com
By Andrew Conte and Brian Bowling
Tribune-Review
The University of Pittsburgh Medical Center's practice of transplanting livers into less-critically ill patients extends into its adult live-donor program, which has led the country in number of transplants four of the past five years.
Live-donor liver transplants in patients who are still relatively well not only can hurt the recipient's survival odds, but unnecessarily risk the lives of the donors, said Dr. Goran B. Klintmalm, chief of the Baylor University Regional Transplant Institute in Texas.
"This is not a benign process," he said. "The recipient has to be sick enough to warrant the risk that you pose to the donor."
Evidence suggests that some transplant centers across the country are performing live-donor liver transplants "earlier than what might be considered optimal," said Dr. Mark S. Roberts, chief of Decision Sciences and Clinical Systems Modeling at the University of Pittsburgh School of Medicine.
He and Andrew Schaefer, a researcher in the department of industrial engineering, have been trying to determine the best time for patients with liver disease to accept a live-donor transplant. Liver patients are ranked by a blood test score called MELD, for Model End-stage Liver Disease, which ranges from 6 for the least ill to 40 for the sickest.
Patients who have cancer or severe quality-of-life issues can apply for exception points to have a low score raised. In rare cases, transplants in patients with low-MELD scores may be necessary even if the person does not qualify for exception points.
The optimal MELD score for live-donor transplantation varies by the type of disease and the patient's location in the country, but ranges from 14 to 20, Roberts said.
Since 2003, UPMC has performed 91 live-donor liver transplants in adults who scored MELD 13 or lower.
With 46 cases, Northwestern Memorial Hospital in Chicago had the second-highest total of live-donor transplant recipients with MELD scores of 13 or lower in that same period.
"There's no question, people who get a transplant need a transplant," said Dr. Michael M. Abecassis, Northwestern's chief of transplantation. "The question is, when?"
Overall, UPMC has performed 165 live-donor liver transplants since 2000. It has never had a donor die.
A year after surgery, 88 percent of UPMC's live-donor recipients are still alive, according to data from the Scientific Registry of Transplant Recipients, an agency based in Ann Arbor, Mich., under federal contract to track and analyze data involving transplants. That rate is within the medical center's "expected" survival rate as defined by the registry.
Nationwide, nearly 91 percent of live-donor recipients remain alive a year after transplant.
In live-donor operations, surgeons take a section of healthy liver from a living donor and transplant it to replace the recipient's failing liver. Under ideal circumstances, both livers grow to normal size within two months.
UPMC said this month that it has initiated a review of complications among patients in its live-donor liver transplant program. It has pulled together a team of experts, some from outside the United States, to review its practices. The study will be peer-reviewed, with findings published in a scientific journal, UPMC spokesman Paul Wood said.
Dr. Amadeo Marcos, who came to Pittsburgh in 2002 as a pioneer in using live donors, resigned as UPMC's transplant chief this month. He said at the time that he was stepping down for personal reasons and not anything related to the review.
As more live-donor liver transplants have been performed, transplant surgeons have become "impressed by the frequency of complications -- not necessarily lethal -- but complications," Baylor's Klintmalm said.
The number of live-donor liver transplants across the country peaked at 411 nationally in 2001, and declined to 198 last year. By comparison, the nation's 127 liver programs performed 5,851 transplants with organs from deceased donors in 2006.
The number of adult live-donor transplants at UPMC sharply dropped to 19 in 2007 from 36 each in 2005 and 2006. The medical center has performed just four such transplants since September, according to data from UPMC and from the United Network for Organ Sharing, an agency contracted by the federal government to oversee transplant policy. The UNOS data includes exception points.
"The volume of transplants has nothing to do with our ongoing study of living-donor liver transplants," Wood said.
UPMC has been doing fewer adult live-donor liver transplants because of factors such as the needs of patients on the waiting list and the willingness of people to be donors, said spokeswoman Maureen McGaffin. Also, Marcos frequently traveled to UPMC's transplant facility in Palermo, Italy, in 2007, she said.
UPMC follows federal UNOS guidelines for liver transplants, McGaffin said.
"UPMC accepts patients solely on what is in the best interest of the patients, consistent with the UNOS guidelines," she said. "MELD scores for our patients are in line with those at other major transplant institutions."
Concerns over live-donor transplants in less-critically ill patients are separate, but similar, to those for deceased-donor transplants, surgeons said.
The Tribune-Review reported this month that hundreds of patients nationwide each year undergo liver transplants from deceased donors when they don't need the surgeries. One in ten dies.
UPMC and three other liver programs have led the country in doing deceased-donor liver transplants among less-critically ill patients since 2005.
Patients with scores of 14 or lower face a greater risk of dying within a year if they undergo a liver transplant from a deceased donor than if they continue waiting, according to the scientific registry's research, which did not look at live-donor transplants.
UPMC performed 12 live-donor liver transplants in patients with MELD scores of 13 or lower last year, compared to 23 each in 2006 and 2005.
Nationwide, about 88 percent of patients with one of two types of liver disease -- primary biliary cirrhosis or primary sclerosing cholangitis -- who undergo live-donor transplants do so before reaching an optimal MELD score, Roberts said. The research, he said, takes into account only length of life, not quality of life.
Researchers involved in an ongoing U.S. National Institutes of Health study have found that live-donor liver transplants work about as well as those using whole organs from deceased donors in nine centers, not including UPMC. A year after surgery, 81 percent of the partial livers from live donors in the study were still working for patients. Grafts of whole livers from deceased donors continue working a year later about 82 percent of the time.
Still, the use of live donors for liver transplants has never lived up to its promise of easing the demand for organs from deceased donors.
In 1999, Dr. John Lake, director of liver transplants at the University of Minnesota Medical Center, predicted live-donor transplants might rival or exceed those from deceased donors.
"I was dead wrong," he said this past week.
A high-profile donor death in 2002 soured some centers on performing the transplants; implementation of the MELD scoring system that year reduced the need for live donors, and estimates about rising demand from patients with Hepatitis C never materialized, he said.
Lake's program was one of two that surpassed UPMC in 2007 by performing 24 live-donor liver transplants. Lahey Clinic Medical Center in Burlington, Mass., performed the most live-donor liver transplants at 26, compared with 19 for the same time frame at UPMC.
Lake's program did just four in patients with MELD scores of 13 or lower. Minnesota's patients with low-MELD scores typically get live-donor transplants only if they have cancer but do not qualify for exception points, Lake said.
"When we talk about doing live donors, they're almost invariably MELD 15 to 25," Lake said. "Fifteen, because that's when we're convinced patients get a survival benefit."
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Study: State skimps on pay for public service workers
http://www.miamiherald.com
By Brent Kallestad
Associated Press Writer
TALLAHASSEE, Fla. -- Eight years ago Kelvin Haywood needed surgery for a dislocated spine after being choked unconscious by an inmate at the state hospital where he works. He's still being tested for HIV and hepatitis after being bitten on his upper arm by another inmate a year ago.
His pay for dealing with dangerous inmates: $24,000 a year.
"A lot of families, husbands and wives, put their paychecks together to make ends meet," said Haywood, who protects doctors and other professional staff at the state hospital in Chattahoochee.
Haywood, 47, is among thousands of low-paid state workers with dangerous jobs and has little hope of a raise this year. That's in a state that spends less per capita on its work force than any other, according to a recent study by the Pew Center on the States and Governing.
"Over the past 10 years we have fallen farther and farther behind," said Doug Martin, legislative and communications director for the Florida branch of the American Federation of State, County and Municipal Employees. "Now when the budget turns down the public servants are the ones who have to suffer."
Although Pew gave the state a B-minus overall for its across-the-board governing performance in a recent analysis, it was dead last in the investment made in state employees.
"A travesty," responded state Rep. Lorranne Ausley, who blames much of that poor ranking on former Gov. Jeb Bush. "All they did was take away all the protections for state employees. There were two years during the Bush administration where they got no raises at all."
Ausley, a Tallahassee Democrat, contends that pay and benefits improvements for state workers should be lawmakers' top priority and not the last. But with lawmakers now slashing the budget with the economy in tatters, the outlook isn't a lot brighter.
Elva McCaig of Milton has been a licensed practical nurse for more than eight years at a Panhandle prison where she earns less than $30,000 annually and must use vacation time and spend her own money to maintain her professional credentials.
And to make things even more difficult for some workers, new hires are often paid more because starting salaries have increased since many long-time employees were hired. Those increased salaries weren't given to those already working.
"It does seem like a slap in the face when you have to train somebody with absolutely no experience that makes more money than you do," McCaig said.
State workers are looking at a second straight year without an across-the-board pay increase, although Gov. Charlie Crist has $94 million in his budget recommendation targeted for increasing salary in critical, high turnover jobs. The specific jobs, however, were not detailed in the appropriation.
"It's important to compensate people fairly," said Crist, conceding, "difficult budgetary times. The less you're making the harder it is, no questions about that."
Haywood knows that and says "anything would help" as far as a pay raise. He doesn't see it happening any time soon, though.
"I'll believe it when I see it," Haywood said.
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March 24th, 2007
More Conflicts and Clinic Violations in Hepatitis C Investigation
http://www.injuryboard.com
Posted by Jane Akre
Increasingly what happens in Las Vegas is not staying in Las Vegas.
As Nevada comes close to completing the inspection of 50 clinics for safety violations that may have put patients in danger—seven clinics have been found to have “major infection control problems, such as the reuse of single-dose vials” says Governor Jim Gibbons in a release from his office.
Among the 50 clinics, some had sterilization issues and 17 reportedly had minor problems. The rest had no safety violations.
Corrections to the violations were required to be made immediately while the inspectors were on the premises, according to the Governor’s office in all but one of the clinics.
Two clinics remain to be inspected. One is undergoing remodeling and the other was not operating.
So far there are six confirmed cases of hepatitis C, the contagious blood borne liver disease that resulted from shoddy public health practices at the Endoscopy Center of Southern Nevada.
And this week another case was confirmed from a patient at the Desert Shadow Endoscopy Center, a facility also co-owned by Dr. Dipak Desai.
All six of his clinics have been shut down or are restricted in practice and Dr. Desai has agreed not to practice medicine in Nevada while an investigation is ongoing. The results of tests on 40,000 former patients at the clinic will take months to complete.
Three doctors, friends and business associates of Dr. Desai have been asked by the governor to step down from the state Board of Medical Examiners and so far have refused.
Gibbons says he may forcefully remove them for “cause”.
In an usual twist, one of the Nevada Board of Medical Examiners who was asked to step down, Dr. Daniel McBride, has instead resigned as the chairman and director of an insurance firm that provides doctors coverage against medical malpractice claims.
The Las Vegas Review- Journal reprints the letter: "Please accept my resignation as chairman and director of Nevada Mutual Insurance Company effective immediately. I will remain as a one of the over 1,500 members of the finest physician owned insurance companies in the State of Nevada."
The company, Nevada Mutual, provides liability coverage to doctors in the state to protect them against medical malpractice lawsuits by patients.
The Board of Medical Examiners is supposed to investigate medical malpractice complaints by patients in the state.
"You can't be working for Nevadans on medical malpractice questions and for a medical malpractice insurance company at the same time," Assemblywoman Sheila Leslie, D-Reno, told the Las Vegas Review-Journal.
In February, 40,000 former patients of the Endocsopy Center of Southern Nevada were told they may have been exposed to hepatitis strains B and C and should be tested for the blood diseases as well as be tested for HIV. Federal health officials call this the largest public health notification of its kind in U.S. history.
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Bexar County awaits AG opinion on needle-exchange program
http://www.dallasnews.com
By Karen Brooks / The Dallas Morning News
kbrooks@dallasnews.com
Project to prevent spread of disease legal only in Bexar, yet isn't
SAN ANTONIO – Bill Day uses his shoe to brush aside a couple of used needles littering the ground near a concrete arroyo in a seedy west side neighborhood.
The 73-year-old lay chaplain said he used to work with drug addicts at this spot all the time. He'd park the white minivan paid for in part by St. Mark's Episcopal Church and throw open the trunk.
Sickly and desperate and dying, they'd swarm him as he directed them to places to get help and gave them clean needles in an effort to keep them from spreading HIV and hepatitis C.
Now, the red-haired retiree, himself living with AIDS for the last decade, is awaiting word on whether he'll land in jail for a year for administering a program that has been legalized in every state in the nation but Texas.
Here's the irony: Bexar County is the only place in Texas that has a law on the books intended to authorize a syringe-exchange program. It's also the only major metropolitan area, Dallas included, where churches or nonprofits aren't operating one anyway, with the tacit approval of law enforcement.
But because prosecutors don't believe the 2007 law was written properly, it's now up to Texas Attorney General Greg Abbott to decide whether the law is valid.
Mr. Abbot's opinion is due today. Meanwhile, the needle-swap program is on hold, and the addicts have drifted back into the shadows, sharing needles, dropping them on the ground in parks and playgrounds and neighborhood arroyos, Mr. Day said.
"The epidemic continues, and the misery continues," Mr. Day said. "People are suffering, and it really makes me angry that we have to stop for this."
Mr. Day and two others initially were ticketed for possession of drug paraphernalia. But they could wind up facing stiffer charges of distribution if Bexar County District Attorney Susan Reed moves forward with the case.
Ms. Reed has come under intense public fire since word of the Day bust – which started as a charge similar to a traffic ticket but was upgraded to a Class A misdemeanor by the time it made it to Ms. Reed's office – spread across the nation and brought on editorials and articles from as far away as Los Angeles hammering the Republican DA.
Officials from the district attorney's office said Thursday that they'd wait for the attorney general's opinion to decide how to handle the case but insisted their interest is not a political statement by an office bent on fighting such programs of any kind, as critics have suggested.
"We did not go out looking for this," First Assistant District Attorney Crag Herberg said. "This was not on top of anybody's agenda in this office."
Needle-exchange programs are widely considered by government leaders, law-enforcement officers, church groups and health officials – including the national Centers for Disease Control and Prevention – as highly effective in stemming the spread of HIV and hepatitis C.
Politically, the programs tend to get bipartisan support as a way to save on health-care costs. Advocates also see the programs as a way to maintain contact with addicts and sex workers, with the hope that eventually they'll seek treatment.
But opponents say it condones drug use and sends mixed messages in an anti-drug society. Proponents argue that addicts will use drugs whether they've got clean needles or not.
Mr. Day and other members of the Bexar Area Harm Reduction Coalition, a nonprofit 501c3 group, had been trying for years to get off the ground but had difficulty recruiting people.
The exchange idea had worked in other places. Mr. Day, a retired real-estate appraiser, got the idea from Dallas private investigator Jack Taylor, who runs a similar church-sanctioned program – Dallas Area Needle Syringe Exchange – that's been around for two decades. Austin and Houston have similar programs, run largely underground.
Finally, last summer, Mr. Day's group got funding – largely from churches and grant foundations that support the programs in other states – and began collecting dirty needles and passing out clean ones.
Around the same time, San Antonio Rep. Ruth Jones McClendon drew up legislation creating a pilot program for Bexar County. It passed the Legislature with the help of Republican Sen. Bob Deuell, a Greenville physician, and the support of Sen. Jeff Wentworth, R-San Antonio.
But as the law was about to take effect last fall, prosecutors argued that the law discriminates against other counties by legalizing the program in Bexar but nowhere else and therefore could not be enacted.
The Bexar County district attorney's office warned police and county officials that the law wouldn't hold up in court and that distributing needles was still a crime that would be prosecuted. Any county workers who tried to pass out needles could be arrested.
Mr. Wentworth asked for an opinion from Mr. Abbott to clear up the confusion once and for all.
County commissioners, supporting the program anyway, gave health officials permission to create the Bexar County Harm Reduction Program – similar in name but separate from Mr. Day's group – and to train workers in anticipation of Mr. Abbott's ruling.
If the law is struck down, Ms. McClendon said, she will try again in 2009.
"I frankly do not believe that what Bill Day is doing is against the law," she said. "I believe he and St. Mark's Church are both doing God's work. He is a person that we as Christians ought to be very, very proud of."
Needle exchanges
HOW PREVALENT: Needle-exchange programs are legal in 49 states , either through government-run programs or sanctioned programs run by churches or nonprofits. Texas is the only state without a law legalizing the program, with the exception of the law creating the pilot program in Bexar County currently under review by the Texas attorney general.
WHO SUPPORTS THEM: Church groups, politicians in both parties, and health officials, including the national Centers for Disease Control and Prevention.
WHAT SUPPORTERS SAY: The programs are widely known to be effective in slowing the spread of HIV, Hepatitis C and other diseases among addicts and sex workers. The programs also keep addicts in contact with health care professionals or church workers who could help them. Addicts, they say, will use drugs whether they have clean needles or dirty ones and will share them if they have to.
WHAT OPPONENTS SAY: The programs send the wrong message in an anti-drug society that the government condones drug use. They encourage drug users to continue using drugs if they can get clean needles.
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Risk of Hepatitis C from tattoo art not sharply defined, experts say
http://www.union-bulletin.com
By Sheila Hagar of the Walla Walla Union-Bulletin
While there is a dearth of strong evidence of a link between getting a tattoo and becoming infected with hepatitis C, the potential is there, said Wendy Dillon, coordinator for the state’s adult viral hepatitis prevention program.
“Here’s what I say,” she said at a recent meeting about safe tattooing. “If there is blood-to-blood contact, there is potential.”
While hepatitis A and B are vaccine preventable, no such treatment yet exists for hepatitis C. And no vaccine is likely to show up soon, Dillon said. “The virus mutates so quickly.”
- Hepatitis C is a virus that causes inflammation of the liver and the most common blood-borne infection in the United States.
- Hepatitis C infection can lead to cirrhosis of the liver and liver cancer. After alcohol, it’s the most common cause of chronic liver disease, and the most frequent reason for a liver transplant.
- About 115,000 people are infected with the disease in Washington. It’s spread by exposure to infected blood, but not through food or water, sharing eating utensils or casual contact.
- Symptoms of hepatitis C include loss of appetite, stomach pain, nausea and vomiting, which may occur 40-180 days after contact. Most people, however, never experience symptoms so are unaware they are infected.
- Anyone considering a tattoo or body piercing should consider the health risks. Infection can occur if tools used have someone else’s blood on them and if the artist or the person doing the piercing doesn’t follow appropriate infection control practices.
According to Dillon, the Centers for Disease Control’s position on tattooing is that although some studies have found an association between tattooing and hepatitis C infection in very selected populations, it is not known if this can be generalized to the whole population. No data exist in the United States indicating that persons with exposures to tattooing alone are at increased risk for the virus.
In the last 20 years, less than one percent of persons with newly acquired hepatitis C reported to the CDC had been tattooed.
Educated consumers are their own best advocates, Dillon said. “Knowing what questions to ask and being sure to ask them.”
For more on hepatitis C, contact the state hepatitis hotline at 1-866-917-4HEP. On the Web, visit www.doh.wa.gov/cfh/hepatitis, or the Centers for Disease Control and Prevention at www.cdc.gov/hepatitis.
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Study: Dramatic rise in hepatitis C-related deaths in the United States
http://www.physorg.com
Hepatitis C-related deaths in the United States increased by 123 percent from 1995 through 2004, the most recent year for which data are available. Mortality rates peaked in 2002, then declined slightly overall, while continuing to rise among people 55 to 64 years old. These findings appear in the April issue of Hepatology, a journal of the American Association for the Study of Liver Diseases (AASLD).
Hepatitis C virus (HCV) is the most common blood-borne infection in the United States, affecting about 1.3 percent of the population. Up to one-in-five sufferers develop liver cirrhosis, and up to one-in-20 develop liver cancer. HCV is the top reason for liver transplantation, and the 16th leading cause of premature death in the country. Recent evidence has suggested that disease burden and mortality from chronic HCV infection may increase in the coming years, as the number of persons with longstanding infections continues to rise.
To update estimates of trends and demographics of hepatitis C-related mortality in the U.S., a team of researchers led by Matthew Wise of UCLA and including researchers from the CDC and the Los Angeles County Department of Public Health analyzed mortality rates derived from U.S. Census and multiple-cause-of-death data from 1995-2004. They included 56,409 HCV related deaths, including those for which the disease was the underlying cause; those for which chronic liver disease was the underlying cause and hepatitis C was a contributing cause; and those for which HIV was the underlying cause and chronic liver disease and hepatitis C were contributing causes.
During the study period, HCV-related mortality rates increased from 1.09 deaths per 100,000 persons in 1995 to 2.57 per 100,000 in 2002, before declining slightly to 2.44 per 100,000 in 2004. Average annual increases were smaller during 2000-2004 than 1995-1999. The most dramatic age-specific increases were observed among 45 to 54 year olds who had an increase of 376 percent, and 55 to 64 year olds who had an increase of 188 percent. For the latter group, rates rose for the entire duration of the study.
“The highest mortality rates were observed among males, persons aged 45-54 and 55-64 years, Hispanics, non-Hispanic blacks and non-Hispanic Native American/Alaska Natives,” the authors report. They suggest that demographic differences are related to prevalence among the various populations.
The observed increases likely reflect both true increases in mortality and the growing use of serologic tests for HCV, the authors say. “As such, true increases in hepatitis C-related mortality during 1995-1999 were likely more gradual than the observed trends, and differences in mortality patterns between the time periods are difficult to interpret.” While the study was limited by possible inaccuracies in death certificate data, the authors believe that this more likely lead to an underestimate of the true number of hepatitis C-related deaths.
“In summary, substantial increases in overall hepatitis-C-related mortality rates have occurred since 1995,” the authors conclude. “The relatively young age of persons dying from hepatitis C-related liver disease has made hepatitis C-related disease a leading infectious cause of years of potential life lost as well as an important cause of premature mortality overall.” They point out the ongoing need for measures to prevent progression of liver disease among those infected with HCV, and the need for ongoing analysis of mortality trends.
Source: Blackwell Publishing
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BARACLUDE data show low resistance over 5 years in nucleoside-naive hepatitis B patients
http://www.eurekalert.org
Data indicate pre-existing lamivudine resistance predisposes patients to higher rates of BARACLUDE resistance
(PRINCETON, NJ, March 24, 2008) – New BARACLUDE® (entecavir) data presented today demonstrated a continued low incidence of resistance in nucleoside-naïve patients through five years of treatment. In the nucleoside-naïve chronic hepatitis B patients analyzed, no additional patient developed resistance in the fifth year (n=108). Through five years of treatment, the cumulative probability of developing mutations in the virus that confer resistance to BARACLUDE (also called genotypic resistance) was 1.2 percent. Bristol-Myers Squibb Company (NYSE: BMY) announced the results at the 18th Conference of the Asia-Pacific Association for the Study of the Liver (APASL) in Seoul, Korea.
In lamivudine-refractory patients who received BARACLUDE after treatment with lamivudine failed, the cumulative probability of genotypic BARACLUDE resistance was 51 percent through the fifth year. This finding is consistent with prior observations that the pre-existence of lamivudine-resistant mutations results in an increase in the rate of BARACLUDE resistance.
“Many chronic hepatitis B patients require long-term treatment. Unfortunately, the initial benefits of therapy can be lost after the development of resistance. These five-year BARACLUDE data that demonstrate long-term minimal resistance at 1.2 percent in nucleoside-naive patients can be of great importance for patients,” said Professor Ching-Lung Lai, Chief, Division of Gastroenterology and Hepatology, University of Hong Kong.
Drug resistance occurs when the hepatitis B virus (HBV) mutates, thereby avoiding the effects of the medication. This can decrease the efficacy of the current medication and may compromise future treatment options. To date, studies have shown that multiple mutations are required to develop BARACLUDE® (entecavir) resistance.
“These long-term BARACLUDE data continue to support the observations seen in the first years of treatment and are reflective of BARACLUDE’s high genetic barrier to resistance,” said Helena Brett-Smith, M.D., Group Director of Clinical Research at Bristol-Myers Squibb. “More importantly, we believe the data support BARACLUDE as an important initial treatment choice for chronic hepatitis B, which is a disease that results in a large global health burden.”
About the Analysis
More than 700 patients across six studies initiated therapy on BARACLUDE and were monitored for treatment response and resistance. The year five analysis expands upon previous analyses, adding in information on patients who received treatment with BARACLUDE during the fifth year of follow-up (n=108 for patients in nucleoside-naïve studies and n=33 for patients in lamivudine-refractory studies).
In this comprehensive analysis, all patients enrolled in Bristol-Myers Squibb clinical trials ETV-014, -015, -022, -027, -026 and -901 who experienced a virologic breakthrough1 or whose virus had not yet reached undetectable levels2 at weeks 48, 96, 144, 192, 240 or end of dosing, were sequenced to determine if any changes occurred in the genetic code of the virus that would result in resistance or loss of effectiveness of BARACLUDE.
Nucleoside-naïve patients in this analysis were initially treated with BARACLUDE 0.5 mg in studies ETV-022 and -027 and continued treatment with BARACLUDE 1 mg by enrolling in study ETV-901 with a treatment gap of less than or equal to 35 days. Lamivudine-refractory patients in this analysis initiated therapy on BARACLUDE 1 mg in studies ETV-014, -015, and -026 and continued treatment in study ETV-901 with a treatment gap of less than or equal to 35 days.
1. Virologic breakthrough is defined as a greater than or equal to 1 log increase in HBV DNA from nadir, as measured by the polymerase chain reaction or PCR assay.
2. Undetectable viral load is defined as HBV DNA levels less than 300 copies/mL, as measured by PCR assay.
Viral load reduction in chronic hepatitis B patients treated with BARACLUDE® (entecavir) in nucleoside-naïve and lamivudine-refractory studies was also evaluated.
Data Results
Results from these studies prior to this year five analysis were previously announced on April 14, 2007.
Nucleoside-naïve data
- The incidence of BARACLUDE resistance in patients in nucleoside-naïve studies over time is low, with a cumulative probability of genotypic BARACLUDE resistance of 1.2 percent through five years.
- No nucleoside-naive patient developed resistance (n=108) in year five.
- 93 percent of the nucleoside-naive patients taking BARACLUDE were able to achieve and maintain an undetectable viral load (HBV DNA < 300 copies/mL) through year five (n=108).
Lamivudine-refractory data
- The results in lamivudine-refractory patients in years one through five were consistent with the finding that the pre-existence of lamivudine-resistant substitutions resulted in an increase in the emergence of BARACLUDE resistance, with a cumulative probability of genotypic resistance of 51 percent through five years.
- In year five, 43 percent of lamivudine-refractory patients had virologic breakthrough with BARACLUDE resistance (n=33).
- During this resistance monitoring program, 72 of the 187 lamivudine-refractory patients achieved undetectable viral load ( < 300 copies/mL) and of these, three patients subsequently developed genotypic resistance to BARACLUDE.
Indication and Important Safety Information About BARACLUDE® (entecavir) 0.5 mg/1 mg Tablets
BARACLUDE® (entecavir) is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults where the virus is multiplying and damaging the liver. 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.
For people taking BARACLUDE who have or get HIV (the virus that can cause AIDS) and are not taking medicines for HIV at the same time, some HIV treatments that they may take in the future may be less likely to work. People are advised to get an HIV test before starting to take BARACLUDE and anytime that there is a chance they were exposed to HIV. BARACLUDE will not help HIV infection.
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.
Because BARACLUDE® (entecavir) is removed from the body through the kidneys, a dose adjustment may be required. Healthcare providers may want to perform tests to determine whether a patient needs a lower dose or should take BARACLUDE less often than once a day.
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 breastfeed 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 safety and effectiveness of BARACLUDE in liver transplant recipients is unknown. 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 two hours after a meal and two 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 biopharmaceutical and related health care products company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb at www.bms.com.
BARACLUDE® (entecavir) is a trademark of Bristol-Myers Squibb Company.
Full prescribing information for BARACLUDE, including boxed WARNINGS, is available at http://www.bms.com/.
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March 25th, 2007
Hundreds demand action from state legislators over hepatitis scare
http://www.krnv.com
Hundreds of people packed into a Las Vegas hearing room Monday night to share their concerns over the Hepatitis C scare in Southern Nevada. More than a dozen others joined the meeting via teleconference from Carson City.
Members of the public addressed the legislative committee on health care and Governor Jim Gibbons who joined the meeting on the phone from Carson City. Many demanded action, with some of them requesting that the doctors and nurses accused in the health scare be arrested and others asking for the Governor to be recalled.
Many of those who spoke said they were treated at one of the 50 surgical centers now under investigation. Some say they are still waiting for test results to see if they've contracted Hepatitis C or HIV. Others say they already know their fate.
"Today, I just got the results for me and my wife and one of us is positive," one speaker said.
The speakers questioned the actions of the doctors and nurses who put their health in jeopardy.
One person said, "These guys have committed crimes against 40,000 people that we know of."
Another said "We're supposed to look up to these people and they're ripping us off."
The legislative committee says it will consider all the comments made at Monday's public hearing. They will decide whether to mandate tougher and more frequent inspections of Nevada's medical centers. The committee will hold its next meeting in April.
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March 26th, 2007
Hepatitis C cases expected to soar in a decade
http://www.newsday.com
By Delthia Ricks | delthia.ricks@newsday.com
Cases of hepatitis C, already at epidemic proportions in New York, are expected to jump explosively in the coming decade, increasing the need for liver transplants and fueling a rise in the liver-related death rate, experts said yesterday.
Speaking at a daylong conference on hepatitis C convened by the New York State Health Department, doctors painted a dreary picture of a silent epidemic in which many of those affected are unaware of their condition - until it is too late. The problem is exacerbated by too few doctors and other health care providers capable of rendering expert care to infected patients, said Dr. David Bernstein, chief of the Digestive Disease Institute at North Shore University Hospital in Manhasset, who addressed an array of concerns.
"This is the most common blood-borne infection in the United States," he said yesterday during the meeting at the Graduate Center of the City University of New York in Manhattan.
State health officials estimate that 1 in 24 New Yorkers are infected with hepatitis C, accounting for an estimated 340,000 infections statewide. Nearly 15,000 cases are estimated in Nassau and Suffolk.
New York is in the vanguard of a rising epidemic expected to peak in 2015 when cases of the infection will increase fourfold nationwide, driving a 528 percent jump in the need for liver transplants and a 223 percent leap in the liver-related death rate, experts underscored yesterday.
State health officials hope the focus on hepatitis C will spur more people to be tested. Symptoms are often vague and can be flu-like, typified by extreme fatigue.
Bernstein noted the good news about hepatitis C is that it is curable, and that an estimated one-third of patients clear the infection on their own.
Doctors largely blamed the explosive number of cases on intravenous drug use, but noted the infection, which is transmitted through blood-to-blood contact, can be spread in a variety of ways, ranging from unhygienic tattooing to needle-stick injuries that affect health care providers. Contaminated medical equipment has been a focus on Long Island in the wake of a scare caused by Dr. Harvey Finkelstein last fall.
State lawmakers are considering a measure that would prevent doctors such as Finkelstein from relying on multiuse medication vials in which syringes can be dipped numerous times, potentially spreading viruses from patient to patient.
Dr. Melissa Palmer, a Plainview liver specialist, said Long Islanders are still reeling from the Finkelstein debacle because the Plainview pain specialist double-dipped syringes in multiuse medication vials, forcing more than 600 to be tested for hepatitis C and other blood-borne viruses.
"I know that situations like that can scare people, but getting infected that way is rare," Palmer said. "Most of the cases we are finding are people who have had it for 10, 20, even 30 years and have not known it."
Facts on hepatitis C
- The infection is diagnosed more frequently in men, possibly because there are more male intravenous drug users.
- Women are 45 percent more likely to eradicate the infection on their own; men have only a 15 percent chance. Doctors are uncertain why the disparity exists.
- Interferon, an immune booster, and Ribavirin, an antiviral drug, can cure the infection in some patients.
- About 80 percent of patients with hepatitis C have no symptoms.
Source: New York State Health Department and Plainview physician Melissa Palmer.
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Senior Lookout: Hepatitis C becoming more common in elder population
http://www.gloucestertimes.com
By Anne Springer
Special to the Times
As Baby Boomers age, elder care professionals can expect to see a rise in the number of consumers who have viral diseases that may have been incurred as the result of activity such as intravenous drug use.
In that cohort, illnesses such as bipolar disorder or schizophrenia were often not diagnosed early enough to intervene with therapies that could have prevented a young person from turning to alcohol or drugs to self-medicate. Mental illness was swept under the rug, as if it were somehow not the same as having diabetes or arthritis or any other medical condition.
Veterans of the Vietnam era often came back from the horrors of that war with a drug habit. In the 1980s, cocaine was the cool drug — until it hooked people so badly that a few sniffs up a straw turned into smoking crack from a pipe, or shooting it into one's veins.
Polite society often wants to turn its back on these issues, and assumes that the fault for certain illnesses lies with the individual. But, if a person received blood products as the result of a transfusion, or surgery, prior to the early 1990s, they are also at risk for blood-borne pathogens.
Even when a person acquires an illness as the result of risky behavior, he or she still needs to be cared for with respect. We have come a long way, but have further to go — and it's up to health professionals to lead the way.
HIV/AIDS gets a lot of publicity, but there is another disease lurking in our population. In fact, 80 percent of those infected have no idea that they have it.
Hepatitis C (HCV), in its early stages, often causes no noticeable symptoms at all. The Centers for Disease Control estimate that approximately 4.1 million (1.6 percent) Americans have been infected with HCV, of whom 3.2 million are chronically infected. Of those infected, 75 percent to 85 percent will have chronic infection and up to 20 percent of those people may progress to cirrhosis or cancer of the liver. One percent to 5 percent of those chronically infected may die of their disease. Symptoms of HCV are fatigue, dark urine, abdominal pain, loss of appetite, nausea and jaundice. Those with advanced disease may also suffer from cirrhosis, ascites (fluid build-up), a reversed sleep pattern (sleeping during day, awake at night), hepatic encephalopathy (confusion, and other symptoms, from accumulation of toxins in the brain), malnutrition, muscle wasting, or clotting difficulties.
Fortunately, the estimated number of new infections per year has declined from an average of 240,000 in the 1980s to about 19,000 in 2006.
Currently, a combination of drugs such as Interferon, Ribavirin and Actigall are the treatment of choice in those individuals who can handle the therapy. These drugs are contraindicated in some patients and are not always successful in eradicating the virus. HCV infection is the leading reason for liver transplantation in the United States, but there are far more infected individuals than donor livers. Lahey Clinic in Burlington has a live donor transplantation program, but not all patients are eligible for such partial liver transplantation and must wait for a cadaver liver.
A new therapeutic DNA vaccine known as ChronVac-C is now in clinical trials, and there is evidence of its ability to invoke the desired immune response against Hepatitis C.
Inovio Biomedical Corp. (AMEX:INO) announced that its partner, Tripep AB of Sweden, has reported preliminary results from the first patient to complete treatment delivered using Inovio's electroporation-based DNA delivery system. In the clinical study, the treatment has so far been safe and tolerable.
Until better treatments or a preventive vaccine is fully available, however, universal precautions that keep workers safe should be stressed in both medical and social service environments, victims should be treated with respect regardless of how they acquired the infection (which often takes 20 years or more to progress to the point where symptoms become problematic), and people with risk factors for blood-borne illness, and hepatitis C in particular, should be encouraged to get tested, both to access treatment at the earliest possible juncture and to be proactive about warning the people in their lives to take precautions against infection as well. No one should share toothbrushes, razors or be tattooed by anyone who is not educated in safe practices.
To learn more about hepatitis C, visit
www.nlm.nih.gov/medlineplus/hepatitisc.html.
For information about universal precautions:
www.who.int/injection_safety/toolbox/docs
/AM_HCW_Safety.pdf
For more information on all liver diseases:
www.liverfoundation.org .
Anne Springer is the public relations director for SeniorCare Inc., which serves Beverly, Essex, Gloucester, Hamilton, Ipswich, Manchester, Rockport, Topsfield and Wenham. Its mission is to provide and coordinate services to elders, enabling them to live independently and remain part of their community.
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Cangene’s Anti-hepatitis B Product Gets Orphan-drug Exclusive Approval From FDA
http://www.rttnews.com
Cangene Corp. (CGNOF.PK, CNJ.TO) said its HepaGam B, Hepatitis B Immune Globulin Intravenous, received orphan-drug exclusive approval from the United States Food and Drug Administration, or FDA, for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen positive liver transplant patients.
The company noted that this approval gives HepaGam B seven years of market exclusivity, while facilitates the recovery of certain regulatory filing fees.
Once a product receives orphan-drug exclusive approval for use in the disease or condition, FDA would not approve another sponsor's product for that use for seven years.
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Patient turns harsh light on clinics reusing syringes
http://www.usatoday.com/
By Janet Kornblum, USA TODAY
When Evelyn McKnight was diagnosed with breast cancer in 2000, she knew she was facing the fight of her life. What she couldn't know was that the people treating her cancer would cause another life-threatening illness.
In 2002, McKnight, 53, an audiologist from Fremont, Neb., found out she had been infected with hepatitis C a year earlier at the clinic where she went to get chemotherapy. It turned out the clinic was reusing syringes and spreading infections.
She was one of 99 people at the clinic in Fremont, population 25,000, to be infected with the liver disease often associated with IV drug users, the Centers for Disease Control and Prevention says.
"I went to the doctor to be healed, and I came away with a life-threatening illness," McKnight says. "There is a huge sense of betrayal."
To keep that from happening elsewhere, last fall she co-founded a patient advocacy group, HONOReform, that uses advocacy and education to stop the kind of medical errors by which blood-borne diseases are transmitted.
So when she heard about the latest outbreak, which came to light late last month in Las Vegas, "I just felt sick to my stomach. This shouldn't still be happening. This should not be going on in a first-world country in 2008."
But it is.
Though the vast majority of medical professionals practice safely and cleanly, 31 outbreaks of viral hepatitis associated with unsafe medical practices, including those in Fremont and Las Vegas, have occurred since 1999, the CDC says. An outbreak is defined by two or more people being infected.
Letters to 40,000 people
In the case in Las Vegas, seven people with acute hepatitis C were found to be infected at two related endoscopy centers, according to the Southern Nevada Health District.
Health officials have sent letters to about 40,000 people who were treated between March 2004 and Jan. 11, urging them to be tested for hepatitis C, hepatitis B and HIV. Officials may not know for several more months how many people are infected, says Brian Labus, senior epidemiologist for the Southern Nevada Health District.
Though most people know sharing needles is unsafe, sharing or reusing syringes can be equally dangerous.
During an injection, a tiny amount of blood is often inadvertently drawn back into the syringe. Most of the time, that doesn't make a difference because it is common practice to use a new syringe and a new needle for each injection.
But in some cases, practitioners may change the needle but not the syringe, says Michael Bell, CDC associate director for infection control.
They then use that dirty syringe to draw more medicine from a vial. By doing so, the small amount of blood that was in the dirty syringe inadvertently flows back into the vial, contaminating the entire vial.
Getting the word out
In Las Vegas, health practitioners giving patients anesthesia were reusing syringes routinely, Labus says. "This wasn't something that just occurred on one day. They were basically doing something that was a dangerous practice over an extended period of time."
That specifically runs contrary to commonly accepted medical protocol, Bell says. That it's happening in more than one place "is very concerning," Bell says. "And we want to make sure that the word gets out as quickly and as completely as possible that these are unacceptable errors in practice."
For McKnight, that word can't travel fast enough.
McKnight says HONOReform has helped her heal emotionally. Her group has called for congressional hearings as well as more spending to study the problem and improve education.
But she still must deal with the everyday reality of her illness.
Symptoms of hepatitis C can range dramatically from one person to the next. About 20% immediately develop acute infections with symptoms ranging from jaundice and fatigue to abdominal pain, and 80% don't develop signs or symptoms, according to the CDC. However, 75% to 85% may develop a chronic infection but may not exhibit symptoms for many years. Of those with chronic infections, 20% may develop cirrhosis, and 1% to 5% may die as a result of liver disease.
There is no vaccination for hepatitis C and no one universal cure, although treatments can work for many.
For McKnight, whose cancer is in remission, chronic hepatitis C "is like having the flu 24/7. I'm fatigued. I have body aches. It certainly is compromising the quality of my life."
McKnight is careful to keep her razor and toothbrush separate from her husband's, and if she does cut herself shaving, she has to dispose of any bloody tissues safely.
'It's needless suffering'
The other day she tripped while walking from the pool to the hot tub at the YMCA. She scraped her toe, and it was bleeding. Several people instinctively rushed to help her. "I said, 'Don't touch me. Don't touch me. I have hepatitis C. Don't touch me.' "
Her husband, a family physician, helped her while the lifeguard used yellow biohazard tape to cordon off the area. All for a scraped toe.
"It was embarrassing," she says. "Everybody was trying to help me, but it just drew a lot of attention to an unpleasant thing in my life.
"I don't want that to happen to anybody else anywhere in the United States again. It's needless suffering."
HOW REUSE OF SYRINGES CAN PASS ON INFECTION
One way that a hepatitis C virus (HCV) infection can spread is through reuse of syringes combined with use of single-dose vials for multiple patients undergoing anesthesia. The syringe doesn't have to be used on multiple patients for this to occur.
1. A clean syringe and needle are used to draw a sedative from a new vial.
2. The sedative is then injected into a patient who has a hepatitis C infection. Backflow into the syringe contaminates the syringe with HCV.
3. The needle is replaced, but the syringe is reused to draw additional sedative from the same vial for the same patient, which contaminates the vial with HCV.
4. A clean needle and syringe are used for a second patient, but the contaminated vial is reused. Subsequent patients are now at risk for infection.
Source: The Southern Nevada Health District
THOUSANDS NOTIFIED
In the past year, five incidents of syringe reuse have resulted in patients being notified that they had to be tested for hepatitis B, hepatitis C and HIV.
- New York City Endoscopy 4,500
- Long Island, N.Y. Pain management 10,400
- Michigan Dermatologist (fraud investigation) 13,000
- Long Island, N.Y. OB/GYN (influenza vaccination) 35
- Nevada Endoscopy 40,000
Source: Centers for Disease Control and Prevention
For more information, visit www.honoreform.org and www.cdc.gov/ncidod/diseases/hepatitis/index.htm.
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Laser Ablation Safe, Effective for Small Hepatocellular Tumors
www.medscape.com
NEW YORK (Reuters Health) Mar 13 - Percutaneous laser ablation is a safe and effective treatment for small hepatocellular carcinoma (HCC) nodules, researchers from Italy report in the March issue of Radiology.
Dr. Vincenzo Arienti and colleagues from Maggiore Hospital in Bologna reviewed liver tumor databases from nine treatment centers. They identified 520 men and women who underwent percutaneous laser ablation between 1996 and 2004 for a total of 647 HCC nodules of any size (small, 0-3 cm; intermediate, 3-5 cm; large, greater than 5 cm; mean diameter, 3.2 cm).
The primary effectiveness rate - defined as the percentage of HCCs completely ablated after percutaneous laser ablation - was 60% in all HCCs and 81% in HCCs smaller than 3 cm, the team reports.
Major complications occurred in 15 (1.5%) of 1004 percutaneous laser ablation sessions and were associated with technical or anatomic factors, but not HCC diameter or patient characteristics.
In multivariate analysis, the likelihood of a major complication was estimated to be 22-times higher in patients with a deep nodule compared with patients with a superficial nodule, and 32-times higher if the laser energy level exceeded 7200 J, regardless of nodule size.
Minor complications -- mainly asymptomatic perihepatic fluid collection or minimal subcapsular hematoma -- occurred in 62 (6.2%) of 1004 laser ablation sessions and were associated with lower prothrombin time, higher mean bilirubin and excess energy, according to the investigators.
In this study, neither needle track seeding nor unexpected tumor spreading was observed.
Four of the 520 patients died, resulting in a mortality rate of 0.8%, which "may be comparable with the rates reported for other ablation techniques," Dr. Arienti and colleagues say. "It is important to note," they add, that all four deaths occurred in patients with advanced liver disease (cirrhosis and/or HCC) and only during the initial period (1996 to 2000) "when patients with Child-Pugh grade C, coagulation deficit, or large HCC nodules were not always excluded from treatment," they note.
Dr. Arienti and colleagues conclude that percutaneous laser ablation can be considered an alternative option to percutaneous ethanol injection and radiofrequency, "owing to its low number of complications and its primary effectiveness rate in small HCCs."
Radiology 2008;246:947-955.
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Gene therapy breakthrough is 'tip of iceberg'
http://www.telegraph.co.uk
By Nic Fleming, Science Correspondent
Scientists have developed an innovative way to manipulate genes, leading to hopes of new treatments for a wide range of diseases including cancers, heart disease and diabetes.
Researchers have revealed a breakthrough that could allow them to boost production of chemicals in the body that are depleted in many illnesses.
Just three injections of a new drug reduced cholesterol levels in mice and monkeys by 30 per cent, as well as preventing hepatitis C infection.
It is the first time the technique, called microRNA inhibition, has been successfully used on non-human primates.
Keith McCullagh, chief executive of Denmark-based Santaris Pharma, which carried out the research: "This is just the tip of the iceberg.
"When things start to go wrong in diabetes, heart disease and cancers, one of the first things to change is the microRNA. It's the genetic mechanism by which the proteins change in disease.
"This field is going to be hugely important for understanding disease and developing new treatments."
The instructions that control cells are contained in DNA. Many biological processes including healthy tissue maintenance and damage caused by disease are triggered by the copying of DNA to produce ribonucleic acid (RNA), which is used to form proteins.
Two forms of RNA either boost or suppress protein production, and scientists have in recent years discovered this system is central to a range of illnesses, including cancers, viral infections, cardiovascular disease and neurological disorders.
Previous attempts to manipulate this process have failed because the drug molecules used were too large to get to the target cells.
Now scientists at Santaris Pharma have developed smaller compounds that can cross cell membranes and intercept the microRNA molecules that usually put a brake on protein production.
Dr Joacim Elmen, of Sanatris, and colleagues, whose study was published in the journal Nature, successfully used the method to manipulate gene activity in mice and monkeys.
Mice on a high fat diet were given three injections of a drug to block miRNA-122, a compound in the liver that controls cholesterol levels.
Those given the highest dose had 30 per cent lower cholesterol levels than those given placebo injections, and the effects lasted three weeks after the last injection.
Similar effects were demonstrated in African green monkeys - the first successful demonstration of miRNA inhibition in non-human primates.
Laboratory tests also showed that blocking miRNA-122 also prevented the hepatitis C virus replicating.
Human trails of a drug to treat hepatitis C will begin next year and scientists are using the method to develop a treatment to combat blood cancers.
Santaris predicts new therapies will be ready for use by patients within five years if trials go well.
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State to be sued by hepatitis B carriers, who top 1 million
http://www.japantimes.co.jp
By AKEMI NAKAMURA
Staff writer
Infected Via Mandatory Group Vaccinations
In the wake of the recent ground-breaking out-of-court settlement with people who contracted hepatitis C from tainted blood products, the government will face a fresh legal battle waged by hepatitis B carriers.
People who are believed to have contracted hepatitis B through mandatory vaccination against infectious diseases, including polio, measles and influenza, plan to file a series of damages lawsuits nationwide against the government.
Spearheading the move, several hepatitis B carriers will file suit Friday with the Sapporo District Court, demanding the state pay each plaintiff from ¥15 million to ¥60 million in compensation and take relief measures to help them treat the disease.
"I believe there are a lot of hepatitis B patients who have faced discrimination" due to the public misconception that the virus can be easily transmitted, said a 34-year-old Ibaraki Prefecture woman with hepatitis B who plans to join the Sapporo suit. "There must be many patients who have been struggling with the disease (alone).
"I hope that this legal battle makes the public recognize that the main cause of the infection was vaccination" and that anyone could have contracted it in this manner.
With proper understanding of the disease, hepatitis B patients can at last talk about it freely, she said.
According to the Health, Labor and Welfare Ministry, there are more than 1 million hepatitis B carriers in Japan.
Hepatitis B or C is a serious disease that weakens the liver. Its symptoms include fatigue, poor appetite and nausea, but they can be so mild that carriers of either disease may be unaware of their infection. The carriers can develop chronic hepatitis, which can progress into cirrhosis and then liver cancer.
About 10 percent to 15 percent of hepatitis B carriers develop chronic hepatitis, but the corresponding figure for hepatitis C carriers rises to 65 percent to 70 percent.
A majority of hepatitis B carriers in Japan probably contracted the virus through group vaccinations, said Shinsho Yoshiba, a professor of gastroenterological medicine at Showa University Fujigaoka Hospital in Yokohama.
Mandatory vaccinations helped prevent infectious diseases from spreading after the end of World War II. The diseases targeted included typhoid, diphtheria, smallpox, polio, influenza and measles.
Until the mid-1970s, however, when disposable needles and syringes became available, sharing syringes and needles with others had been a common practice during group vaccinations at public health centers and clinics, according to Yoshiba, an expert on hepatitis.
The Ibaraki woman may be one of the unfortunate cases who contracted hepatitis B through a group vaccination. She was diagnosed with the disease over a decade ago when she received an annual medical checkup as a university student in Sapporo.
Her doctor told her she probably contracted the virus via a group vaccination she received as an infant because she had never suffered from a serious disease or had injuries requiring a blood transfusion and her mother is not a hepatitis B carrier.
She has fortunately not experienced serious symptoms to date, but has suffered from the psychological strain of being a carrier of the disease.
She needs to take care not to work too hard because an excessive workload could lead to severe hepatitis B symptoms. She is also advised to get a regular medical checkup once every three months. In addition, her husband and two children have been vaccinated against the disease, she said.
Hepatitis B is not transmitted through ordinary social contact. Mother-child transmission can be treated by vaccinating newborns to prevent them from becoming carriers. It is also possible for infection to take place through sexual intercourse. When a hepatitis B carrier marries, the spouse is advised to receive a vaccination to avoid infection.
Professor Yoshiba blamed the government for spreading hepatitis B among the population, noting authorities could have taken action earlier to prevent the infections, because the World Health Organization warned in 1953 that hepatitis viruses can be contracted by sharing syringes or needles, he said.
"The government was directly involved in the mandatory vaccinations and bears a heavy responsibility for spreading the infections," Yoshiba said.
The argument has been supported by the Supreme Court. In 2006, the top court recognized that five hepatitis B carriers, who filed a damages lawsuit with the Sapporo District Court in 1989, contracted the virus through group vaccinations and ordered the state to pay ¥5.5 million in compensation to each plaintiff.
Yoshiba said that it is natural to presume that there are other hepatitis B carriers who contracted it through mandatory group vaccinations.
But a health ministry official said that the ruling only applies to the five plaintiffs and the ministry needs to examine each case on its merits if more hepatitis B carriers file similar suits.
Takahiro Okuizumi, one of the lawyers for the hepatitis B plaintiffs, said the planned lawsuits will put pressure on the government to take relief measures to support victims of group vaccinations as it agreed in January with hepatitis C plaintiffs who contracted the disease from tainted blood clotting agents.
The hepatitis B plaintiffs will demand that the government shoulder medical expenses that they have to pay for treatment and provide financial assistance to patients who cannot work due to the disease, he said.
The infections could have been prevented if the government strictly regulated the sterilization of syringes and needles each time by, for instance, boiling them, Okuizumi said.
"There must be a great number of potential hepatitis B carriers" who contracted the disease through mandatory vaccinations, he said. "The problem is that the government has not taken any measures to help them."
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March 27th, 2007
Blood Tests Suggested in Hepatitis Scare
http://ap.google.com
NEWPORT NEWS, Va. (AP) — A Virginia hospital has asked more than 300 former patients to come in for blood tests because a nurse suspected of infecting patients with hepatitis in Texas worked there last year.
Retired Army Capt. Jon Dale Jones, 45, was arrested this month in Miami on federal charges of assaulting three patients and possession of a controlled substance by fraud.
Federal prosecutors said they believe Jones spread hepatitis in 2004 at an El Paso military hospital by diverting fentanyl — a powerful painkiller often used for anesthesia — from patients to himself.
At least 15 military service members or their relatives are believed to have been infected.
Officials at Riverside Regional Medical Center in Newport News said Jones worked there from July through December. Staff members have identified 310 patients who came into contact with Jones and asked them to return for tests for hepatitis C.
Hepatitis C is a blood-borne disease that can lead to cirrhosis of the liver or liver cancer. It is treatable, but there is no cure. Symptoms vary but can include nausea, vomiting, diarrhea, fatigue, pain and jaundice.
It's not clear exactly how the patients in El Paso were infected. Jones, 45, has denied using dirty needles. He has pleaded not guilty and was released on bond.
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Providing hope for hepatitis C victims
http://www.thisisthenortheast.co.uk
By Barry Nelson
PHOTOGRAPHS of a North-East man will be on show throughout the region today as part of a campaign to raise awareness about hepatitis C and to save lives.
Jeff Temple, 54, from Carrville, near Durham City, discovered he had hepatitis C when he went to donate blood in 1994.
He allowed his image to be used as part of an NHS travelling exhibition designed to encourage more people to come forward for hepatitis testing and treatment.
Today, that exhibition is in the Market Place, Durham City.
Hepatitis C is a blood-borne virus that can cause chronic infection and lead to serious liver damage, including cirrhosis and primary liver cancer.
It is estimated that about 200,000 people are infected with hepatitis C and the majority are probably unaware of their infection.
While there is no vaccine, effective anti-viral drug treatment is available from the NHS.
"I just hope it encourages people to get themselves tested. Hopefully, by raising awareness of hepatitis C in this way it could save a few lives," said Mr Temple, who will be available to answer questions during the day.
A large drum-shaped display featuring photographic portraits of people from all over the UK who are living with hepatitis C will be on display.
One of the portraits is of Michele Martinoli, a Swiss photographer who was diagnosed with hepatitis C in May 2003.
Initially told that she had advanced liver damage, she began a successful course of injections which cleared up the virus.
Mr Temple recently started a course of injections to cure him of hepatitis.
When he was first diagnosed there was little treatment and even in recent years, when an antiviral drug was developed, it was so expensive that it was only used for patients who had become very ill.
"That has all changed and now it is accepted that the best thing is to get treatment at the early stages of the disease," he said.
"The message is, treatment can clear up the virus, so don't be afraid of getting help by calling the hepatitis C information line, your doctor or nurse."
The exhibition will also be attended by Ms Martinoli and Dr Deborah Wilson, consultant in communicable disease control at County Durham and Tees Valley health protection unit.
The Hepatitis C Trust helpline is 0845- 233-4424.
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Allmans scrap shows as singer fights hepatitis C
http://nz.entertainment.yahoo.com
LOS ANGELES (Reuters) - Veteran southern rock group the Allman Brothers Band said Thursday it postponed 15 shows scheduled for May at New York's Beacon Theatre while singer Gregg Allman recovers from treatment for hepatitis C.
The virus has been "eradicated" from Allman's system after a six-month treatment program, but it has left him tired, according to a statement.
"I need to be at 110% to do the shows the way we do them," said Allman, aged 60.
The annual Beacon run was scheduled for May 5-24; rescheduled dates will be announced soon. The band has also pulled out of the annual Wanee Festival, set for April 11-12 in Love Oak, Fla. But a 12-concert run planned for August will go on as scheduled, the statement said.
The Allman Brothers Band, put together in 1968 by Gregg's late brother, Duane, is best known for such classic-rock anthems as "Ramblin' Man," "Midnight Rider" and the epic "Whipping Post." (Reporting by Dean Goodman)
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March 28th, 2007
Government of Canada Funds Research to Address Hepatitis C Virus in Central Alberta
http://www.marketwire.com
RED DEER, ALBERTA--(Marketwire - March 28, 2008) - MP Bob Mills, Member of Parliament for Red Deer, today announced on behalf of Health Minister Tony Clement, a $10,000 contribution to the Central Alberta AIDS Network Society (CAANS) to fund a project that aims to reduce the incidence of hepatitis C virus (HCV) in Central Alberta by assessing the health needs of those most at-risk of becoming infected.
The project, entitled Street Smarts Outreach: Rural Needs Assessment in Central Alberta, will determine the health needs of drug users in the region and the capacity of rural communities to increase HCV awareness and prevention initiatives.
"For our government, protecting the health and safety of Canadians is paramount" said Member of Parliament Bob Mills, "That's why we are pleased to be investing in this initiative which will help prevent hepatitis C infection and chronic liver disease, and will also help people to better manage their health."
HCV is spread through contact with infected blood and causes an inflammation of the liver that can lead to cirrhosis and liver cancers. Approximately 250,000 people in Canada are living with HCV and approximately 3,200 newly acquired infections are diagnosed each year. Conditions caused by HCV (e.g. cirrhosis or inflammation of the liver) progress slowly, and symptoms may not show for up to 20 years; therefore, approximately 35 per cent of those persons living with the virus are unaware that they are infected.
"This project allows us to examine the factors that put people at risk of becoming infected with HCV in our community," said Jennifer Vanderschaeghe, Executive Director of CAANS. "By gaining a better understanding of the health interventions that at-risk populations need, and the capacity our healthcare providers have to meet that demand, we will gain valuable insight into what measures are appropriate to reduce the spread of HCV in our region."
The most common risk factors for HCV infections include:
- Sharing needles or other drug-related equipment;
- Getting a tattoo, body piercing or acupuncture from an operator who does not use sterilized equipment or techniques;
- Being born to a mother with HCV;
- Being exposed to infected blood in the workplace, such as needle stick injuries, or any other incident where inflected blood comes in contact with broken skin; and
- Sharing personal items (like a razor or toothbrush) with an infected person.
Persons who were exposed to contaminated blood, blood products or organ transplantation prior to 1992 may also be at risk.
The Government of Canada recognizes that hepatitis C is a serious public health issue, which is why in 2006 the Prime Minister of Canada set aside nearly $1 billion in a special settlement fund to provide compensation to those who were infected with Hepatitis C through the blood system prior to January 1, 1986 and after July 1, 1990.
For more information about HCV, visit:
http://www.phac-aspc.gc.ca/hepc/faq_e.html
http://www.hc-sc.gc.ca/iyh-vsv/diseases-maladies/hepc_e.html
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Hepatitis C Investigation Creating Doctor Shortage
http://www.ktnv.com
Health experts estimate the Hepatitis C scare is taking a toll on gastroenterologists in the Valley.
Officials found staff at the Endoscopy Center of Southern Nevada reused syringes on patients, putting thousands of people who visited the Shadow Lane office at risk for various viruses.
Before the health scare, there were about 46 GI doctors practicing in Southern Nevada.
Now, there may only be about 18 practicing.
Action News reporter Tania Reyes explains how it is affecting patient care.
The Clark County Medical Society says there is a possibility many of the doctors involved in the Hepatitis scare may not be practicing since some of the clinics closed their doors.
Action News talked to one local gastroenterologist who says within the last month or so his work load has increased significantly.
"This event has been terrible disruption of health care and a terrible ordeal for patients," explained Dr. Frank Nemec.
Doctor Nemec is a gastroenterologist along with five other doctors practice at the Southern Hills hospital.
He says lately there has been a change in the amount of patients coming in.
"The volume has gone up considerably," explained Dr. Nemec.
This doctor speculates he is starting to see patients from the centers which have closed.
The Clark County Medical Society estimates the Gastroenterology Center of Nevada performed about 60% of these type of procedures in Southern Nevada.
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