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Week Ending: October 22nd, 2005
Alan Franciscus
Editor-in-Chief
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This Issue:
• East Village Artist Battles Stigma
• Grim Reality of Prison Health Care -- Doctors, Nurses and Inmates Suffer inside Broken System
• Abbott Advances Blood Bank Testing Technology with U.S. Launch of Abbott PRISM®
• 2 Patients Battle AHCCCS over Treatment Denial
• Hepatitis-C Virus Stopped from Multiplying
• Eli Lilly Expands Cymbalta Liver Warning--US FDA
• Low Morbidity with Right Hepatectomy in Living Donors
• Viral Hepatitis Conference to Take Place February 27-28, 2006 in Boston, MA
• Foes: Amendment Hurts Partner Benefits
• Georgia Woman's Personal Journey Brings Her to W-B
• Proposal Allowing Pharmacies to Sell Needles Rejected
• Par's Generic Copegus Gets Tentative OK
• MultiCell and Thomas Jefferson University to Study Potential Hepatitis C Treatment
• Past Illegal Blood Donation in China Linked to Hepatitis C Virus Infection
• Hepatitis C Found More Frequently in Semen of Men Coinfected with HIV/HCV
• Lawsuit Takes State Prisons to Task for Hepatitis C Treatment
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October 13th, 2005
East Village Artist Battles Stigma
http://www.gaycitynews.com
By RONDA KAYSEN
Performer Penny Arcade goes public about living with hepatitis C
Penny Arcade is accustomed to being noticed. The 55-year-old performance artist has been a poster child for the East Village avant-garde art scene since Andy Warhol roamed the city. In recent years, she’s become a vocal proponent for artists struggling to remain residents of the increasingly gentrified neighborhood. So when she was diagnosed with the hepatitis C virus two-and-a-half years ago, it was only natural that she would slip into the role of unofficial spokeswoman for sufferers of a disease that often strikes people living on the margins.
Arcade was diagnosed the blood-borne disease that attacks the liver in the spring of 2003. Less than a year later, her 57-year-old brother-in-law, Guy Gouin, died of HCV. While Gouin lay dying, Arcade scoured literature about the disease they shared as part of a quest to conquer her own illness.
“When you’re confronted with having an illness, you enter into a maze and it’s up to you to make a decision,” she said this week in a telephone interview. “We have to take responsibility for our own treatment. I had to really become an expert on hepatitis C to find out what was the most appropriate thing for me.”
A chronic disease, HCV has widely disparate effects on different people. According to the city’s health department, 10 percent of people clear the virus from their system after contracting it, but 80 to 90 percent become chronic carriers. Anywhere between five and 20 percent of carriers will develop cirrhosis of the liver. Of those with cirrhosis, between one and three percent will develop liver cancer.
HVC has infected a large swath of the American population. About four million Americans have been infected with the virus and 2.7 million are carriers, 8,000 to 10,000 of whom will die this year from complications. That number is expected to balloon to 30,000 per year by 2015.
A small virus that lives in blood, HCV is quite easy to contract and far more prevalent than HIV, the virus that causes AIDS. HCV rates, however, are much higher among people living with HIV than in the general population. In New York City alone, between 200,000 and 300,000 people are infected with HCV, compared with about 90,000 New Yorkers with HIV in 2003, according to the health department.
People who have injected drugs and those who had blood transfusions before 1992, when blood-screening tests improved, are most at risk. But anyone in contact with infected blood, including healthcare workers and infants born to infected mothers, is at risk. Sexual transmission, while considered rare, has not been ruled out as a risk factor.
Since most people don’t develop symptoms or serious liver damage for decades—and some never do at all—few know they carry a contagious disease that might ravage their liver.
“Even though it’s set to be a pandemic in this country, very few people know about it,” said Arcade.
In August, from the stage at Joe’s Pub on Lafayette Street where she performed “The Essential Penny Arcade” as part of the East Village HOWL! Festival, Arcade told her audience she had HCV.
“I want to make people aware,” she said in this week’s interview. “There’s a lot of stigma to illness in this country… I spent a lot of time with people with AIDS and I know how people treat people with contagious diseases.”
Ironically, Allen Ginsberg, author of the poem “Howl” for which the festival was founded, died of complications from HCV. He is not the only ‘60s icon struck by the disease. Phil Lesh of the Grateful Dead received a liver transplant several years ago, as did David Crosby of Crosby, Stills, and Nash; both suffer from HCV. Ken Kesey, author of “One Flew Over the Cuckoo’s Nest” and famous for his drug experimentation with the Merry Pranksters (out of which the Grateful dead formed and chronicled by Tom Wolfe in “The Electric Kool-Aid Acid Test”) died of liver cancer in 2001, after suffering for years from HCV.
Arcade is not sure how she contracted the illness. During her youth in the East Village, she was part of Andy Warhol’s Factory scene, appearing in the 1971 film “Andy Warhol’s Women in Revolt. She also participated in the “the Lower Eastside drug culture of the late 60’s” when she was 17, she wrote in an e-mail follow-up to her interview.
But Arcade also wonders if she might have contracted it during the four years she lived in Spain in the 1970s or while traveling in Thailand, India, and Indonesia in the 1990s. She believes her brother-in-law contracted HCV while serving in Vietnam. A 2002 survey of 597 homeless veterans found that 42 percent were infected with the virus, according to New York’s health department.
Stigma might be part of the reason why HCV is so rarely discussed in the public arena.
“Once there’s a certain level of stigma, it becomes harder to give people accurate information about a disease and that can be really problematic,” said Tracy Swan, co-infection project director for HIV and HCV at the Treatment Action Group, an AIDS advocacy group located at Houston Street and Broadway. “There’s something about human nature where people really wonder: how’d you get that?”
Miles Keaton Andrew, a 52-year-old author who contracted HCV when he experimented with intravenous drugs as a teenager, has kept a blog, mkandrew.com, since 2001 about his experiences battling the virus. His blog has received a million hits in the past year.
“I understand the whole stigma thing,” he said. “There are a lot of people like me who might have experimented with drugs. Some of us got sick from it and it isn’t anything to be ashamed about.”
This week, Arcade began a 24-week-long treatment program in the hopes of curing herself. Already, she is sharing her experience with those in her community. In an Oct. 2 e-mail to the listserv maintained by the Federation of East Village Artists, an organization founded to support the local arts community, Arcade wrote, “I start [treatment] tomorrow and I have no idea how I will feel, as each person is different. Although my understanding is that you feel worse when the drugs build up in your system.”
A few days later, she wrote the group, “Tonight’s [FEVA] meeting is supposed to be about health insurance. I am not attending as I have started serious medicine for hepatitis C and do not feel well enough to go out.”
Arcade plans to keep a diary of her treatment, which can cause extreme flu-like symptoms that Arcade compared to those from chemotherapy. “I want to write about it,” she said.
Arcade suffers from a strain of HCV that is less common in the United States and more easily treatable, she said, adding that people with her strain have an 88 percent cure rate after treatment. The typical treatment for most American strains ranges from a three-month to a two-year drug therapy program. Treatment does not eradicate the virus in all cases. Some people, however, do not need drug therapy at all.
“Before you go on Interferon”—a drug commonly used to treat HCV—“you try to imagine the sickest you’ve ever been and you figure you’ll be that sick, but the truth is you can’t imagine how sick you’ll be,” said Andrew. “For a year it completely consumes your life.”
Arcade has lived in the East Village since the beginning of the AIDS crisis—she moved there when she was 17—and remembers a time when there was little information about the disease that ravaged her community. “A lot of us thought we were going to get it [AIDS] and we didn’t get it,” she said. “Ten years later to find out that you have a potentially fatal disease is a huge shock.”
Arcade’s self-anointed emergence as East Village HCV spokeswoman coincided with the July launch of an ad campaign by Hoffman La Roche, a pharmaceutical company. The campaign—plastered throughout the city’s subways, in magazines and in newspapers—depicts a man’s face, severely beaten and bruised. The text reads: “If Hep. C was attacking your face instead of your liver, you’d do something about it. Ready to fight back?”
The startling image of a brutalized face has not received a warm welcome from the HCV healthcare community.
“It’s rude and cruel and horrible and stupid,” said Dr. David Ores, a general practitioner on Clinton Street on the Lower East Side. Several of his patients suffer from the virus.
“What if you don’t have insurance?” Ores asked. “What if you have no access to care? You can’t even get tested. Whoever put up those posters, are they offering free healthcare?”
“It’s extremely alarming, from a purely feminist perspective; could you imagine that ad with a woman who’d been beaten black and blue?” said Swan, adding that not all people living with HCV need treatment or develop serious liver damage. “If you had hep C and you saw that, wouldn’t you think ‘Oh my God?’ ”
The ad was intended to alarm, said Bob Madison, a spokesman for Hoffman La Roche. “We really wanted to break through the clutter and do something to separate us from the noise; that’s why it’s such a distinctive campaign,” he said, acknowledging that some response has been negative. “This is a very dramatic call to action.”
Arcade has a publicity campaign of her own in the works. She is currently working with the Lower East Side Biography Project, a media-training program, on a series of public service announcements she hopes will run on cable TV in the spring. For those working in the healthcare industry, Arcade’s decision to go public comes as a welcome voice in a silent arena.
“It’s extremely useful and it’s great that she’s doing this,” said Swan. “Like with the HIV activist model, it’s important to have people in the community sharing information about their experience.”
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October 16th, 2005
Grim Reality of Prison Health Care -- Doctors, Nurses and Inmates Suffer inside Broken System
SourceURL:http://www.sfgate.com
James Sterngold, Chronicle Staff Writer
Soledad, Monterey County -- As the medical staff at the Correctional Training Facility prison gathered recently for its morning meeting, doctors and nurses let loose with another day's frustrations.
A team of guards had shown up unannounced and cleared the infirmary of all black inmates that morning, to avoid fistfights with several Latinos coming in for X-rays. Racial violence has been growing in the badly crowded prison, which was built for 2,815 inmates but holds 7,000. The incursion worsened an already severe appointment backlog.
Then there was the local hospital that wanted to send back an inmate dying of liver disease. The prison didn't have facilities to care for him -- the reason he'd been sent to the hospital twice before, at a cost to taxpayers of $50,877.75 for just 11 days. The staff was scrambling to find a prison that could take him.
Last, the head nurse explained that the infirmary had signed a contract for a mobile CAT scan to come to the prison, instead of transporting inmates to hospitals at high cost. But four months later, it had yet to make a visit because of a dispute over how it would be guarded. (Resolving the problem took several more weeks.)
"They are making one costly error after another, and the problems just get more monstrous," said Dr. Michael Friedman, the chief medical officer. "They keep taking away our tools and telling us to do more."
The infirmary at Soledad, the state's largest prison, provides far from the worst level of medical care. But a day there offered insight into why a federal judge ruled this year that the health care in California's prison system is so bad it violates inmates' constitutional protection against cruel and unusual punishment.
Repairing years of mismanagement by the Corrections Department could cost hundreds of millions of dollars, over the $1.1 billion a year taxpayers already spend on prison health care.
Because of substance abuse problems, violence and often impoverished backgrounds, prison inmates are among the sickest people in the state.
The staff at Soledad treats inmates who have high levels of chronic diseases such as diabetes, asthma and hypertension and near-epidemic levels of infectious diseases like hepatitis C, and who suffer violent injuries as prison crowding stokes tensions.
As courts hand down longer sentences under "three strikes'' and other tough laws, medical staffs also see a growing number of geriatric inmates, many of whom require expensive treatments, even organ transplants.
But the staff also faces the constraints of prison conditions and the bureaucratic failures of the Corrections Department. In prison after prison, the result is critical shortages of doctors and nurses, plummeting morale and growing numbers of preventable deaths.
When inmates aren't properly treated, they return to their communities with costly ailments or carrying communicable diseases.
Unlike most Americans, however, inmates are guaranteed adequate health care. California's prison system has not only failed to provide that minimal level of care, it also has failed repeatedly, in spite of many court mandates and numerous promises of improvements.
Now a federal district judge, Thelton Henderson, is taking control of what is one of the largest health care systems in the country, providing medical treatment for the state's 165,000 inmates.
He is expected to appoint a receiver soon to make changes that experts say could end up costing taxpayers billions over the next decade to do everything from repairing filthy and inadequate facilities to computerizing medical records to paying bonuses to attract qualified professionals.
"By all accounts, the California prison medical care system is broken beyond repair," Henderson wrote in issuing his order this month.
"The harm already done in this case to California's prison inmate population could not be more grave, and the threat of future injury and death is virtually guaranteed in the absence of drastic action."
Inside the prisons, doctors are intensely frustrated not only with their working conditions, but by their feeling that corrections officials in Sacramento have been shifting the blame to them.
Court-appointed experts have issued a stream of reports detailing poor care and shoddy facilities; the bureaucracy and top officials have gone unexamined. Corrections officials have made no effort to defend overburdened medical staff.
J.P. Tremblay, chief spokesman for the Department of Corrections and Rehabilitation, said the judgments came from outside experts, so the department had no basis for countering the findings.
"The system, in my view, is completely corrupted," Friedman, Soledad's medical director, said. "Nonmedical staff are making medical decisions, because everything is about security, not how we look after the inmates.
"And too much power has been taken back to people in Sacramento, who then refuse to make decisions. I have lost my contracts with outside hospitals here because of them, and we cannot hire to fill our vacancies."
Even before remedial programs are in place, costs have been rocketing upward in the prison system; out of a total adult prison budget of $5.3 billion in the coming fiscal year, the state will spend $1.1 billion on health care, double the level seven years ago.
The costs per inmate are among the highest in the nation, yet, according to three court-appointed medical experts, there may be as many as 64 preventable deaths a year because of neglect and malfeasance.
Doctors throughout the system say that while there are certainly some bad doctors, the real problem is weak administration.
"It's obscene to blame the doctors," said Dr. Joseph Bick, chief medical officer at the prison system's health care flagship, the California Medical Facility in Vacaville. "You hear about waste, but waste is not the biggest problem. It's administration, hiring and management."
Bick, himself a court-appointed monitor for a troubled prison in Alabama, said that one-third of his doctor positions are vacant now, double the level a year ago, and that nursing vacancies are now at 54 percent.
At Soledad, the infirmary looks much like any small clinic, neat and well lighted. There is a single guard at the heavy metal entry door.
The waiting room is a series of benches inside a heavy chain-link fence. And the inmates, who show up for appointments right after breakfast, come prepared to wait, most bringing lunches stuffed into clear plastic bags.
Inmates can enter the infirmary only with a special permission slip, called a ducat, and they say the politics of getting those precious slips is a time-consuming game.
The wait hints at the underlying issue: overcrowding. The prison holds 21/2 times as many inmates as it was designed for, and it shows.
A few yards down a corridor from the infirmary is what was once a gym. Now 120 bunk beds are bolted to the floor. All the day rooms along the corridor have been filled with bunks, too.
The infirmary, meanwhile, has been shrinking. Jim Anderson, 63, a longtime nurse who is officially retired but was brought back as a consultant, said that when he started work at Soledad in 1980, the infirmary had 32 beds for a population of less than 3,000; now, for 7,000 inmates, there are 16 beds.
After the morning meeting, Friedman headed to his large, cluttered office. The first thing that greeted him was a pile of inmate lawsuits on his desk.
The lawsuit that brought about court intervention is called Plata vs. Schwarzenegger. It was originally settled several years ago, but because the state consistently failed to meet goals for phased-in improvements, inmates have filed a wave of new suits alleging poor care.
A few years ago, Friedman said, he received requests from state lawyers to respond to one or two suits a month; now, he receives around four a week. On this day there were eight.
At times, he said, just finding patient records can be a burden. All records are kept on paper, not computers, and because of a flood of paperwork, it can take technicians weeks to get all the documents in the proper folders.
Indeed, one thing a visitor notices are the many stacks of paper. The only records kept electronically involve prescriptions. The few computers in the infirmary are used principally for keeping work schedules.
"We're drowning in paper," said Regina Price-Williams, a medical technical assistant.
Late in the morning, Friedman and some of his staff met with the Men's Advisory Council, an elected inmate group. The three inmates, wearing the required chambray shirts and jeans, took their seats in Friedman's office and began working their way through an agenda. No guards were present.
First, the inmates complained about the guards' clearing blacks out of the infirmary that morning.
When the reason for the sweep was explained -- Latino inmates had been attacking blacks, and guards wanted to avoid trouble -- they expressed understanding.
But they insisted that the dislocations could have been avoided with a simple advance phone call. Some of the black inmates had lost appointments for which they had waited months.
The discussion then moved to overcrowding, and emotions began to rise.
The inmates said that because it can take so long to get medical appointments, and because the queues at the infirmary are so long, many inmates refused to go. That meant greater costs later as some illnesses -- everything from asthma or infections to hypertension -- went untreated.
"I can tell you, there's so little space and such a strain on the system, people don't want to come in," said John Thibeault, a council member who is serving a life sentence for murder.
He nodded toward the jammed waiting room.
"That cage is like a dog kennel," he said. "The guy next to you could have something infectious. Some disabled guy has to climb over everyone to get out. Nobody wants to go through that."
Friedman, who joined the facility in 1999 and previously spent 15 years as a military doctor, responded firmly that the crowding was a fact of life.
In short, he said, he was seeking more space, but there was nothing to be done in the short term, and he warned that inmates using stratagems to see doctors early would just make the waits longer for other inmates.
"It's not up to the inmate population to come up with solutions," said Rafael Maldonado, another council member. "You're always going to have frivolous complaints, frivolous litigation and so on. That's not the problem. The problem is severe overcrowding and understaffing."
He added, "We have the largest lifer population of any prison. The inmates shouldn't die before they have a chance for parole. They shouldn't be given a life sentence because they can't get health care."
One service that doesn't suffer from the same problems is mental health care. In response to an earlier class-action lawsuit, the state has spent more on treatment. But the success has proven a mixed blessing.
Bill Zika, the head of mental health care at Soledad, said that because the state has closed so many mental hospitals, prisons are receiving a flood of inmates with serious disorders. Just that morning, he said, a new inmate had showed up intensely psychotic.
"The usual medications have no effect," he said. "Frankly, we see that a fair amount."
The result is that inmates who need treatment for lesser problems, such as anger management and borderline personality disorders, rarely get it. That contributes to the great stress within the prison, and it frustrates inmates' opportunities for parole.
Boyd Hall III, Loyd Beasley and Trenton Powell are all lifers who work as technicians in the infirmary, a privilege. They said that when they have gone before parole boards, they have been praised for their behavior, but they are always asked if they are getting therapy to prepare for the stresses of life outside.
They said they have explained that there are never openings because of the demands of the seriously ill, leaving them stuck.
"Everything bad that happens here is because of the overcrowding," Hall said.
The numbers
- 4 lawsuits per week alleging poor care at the Soledad Correctional Training Facility
- 16 infirmary beds for inmate population of 7,000 at the Soledad prison
- 64 estimate of inmate deaths that could be prevented each year in California prisons
E-mail James Sterngold at jsterngold@sfchronicle.com.
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October 17th, 2005
Abbott Advances Blood Bank Testing Technology with U.S. Launch of Abbott PRISM®
http://www.medicalnewstoday.com
Abbott announced today that the first, fully-automated blood screening instrument, Abbott PRISM® System and a test for hepatitis B, will be available to blood banks across the United States, marking a major step forward in blood bank testing technology. Before a blood donation can enter the blood supply, it is tested for evidence of exposure to viruses that might cause disease. This screening process involves numerous assays, multiple test instruments and many manual steps. The PRISM instrument consolidates much of this testing into a single system, reducing the risk of accidents, errors and tampering by automating the manual testing procedures and steps currently used to screen blood.
"Abbott has a strong history and commitment to ensuring the safety of the world's blood supply. Now, the PRISM system's advanced screening technology will be available to U.S. blood banks for hepatitis core screening, helping to make America's blood supply as safe as possible," said Joseph M. Nemmers, senior vice president, Diagnostic Operations, Abbott. "PRISM's automated technology will minimize the potential for manual errors and allow donated blood to be quickly tested and verified before being released into the blood supply."
Outside the United States, the PRISM system is used in more than 30 countries. Nearly half of these countries rely on PRISM to screen 100 percent of their blood donations.
"Prior to acquiring the PRISM system, infectious disease testing was a very labor intensive process involving numerous steps and requiring more time to test blood before it could enter the blood supply," said Graham Sher, M.D., chief executive officer, Canadian Blood Services, a non-profit organization that manages the blood supply at 42 sites in Canadian provinces and territories outside of Quebec. "The PRISM technology has not only allowed us to enhance the safety of the blood supply by eliminating this manual intervention, but also our organization is able to easily process the sudden increase in collections that are occasionally required during emergencies."
PRISM features a built-in quality control system that monitors critical functions and verifies proper processing of each sample. Blood banks across the U.S. have been eager to bring the PRISM system into their labs due to its ability to handle a high number of tests with very little manual intervention. A mistake made during the screening process may produce a false result that might unnecessarily defer a donor or allow an infected unit of blood to be made available for transfusion.
"Even though donated blood is screened following rigorous protocol to ensure a safe blood supply, there are still a number of manual steps performed in the testing process," said Louis M. Katz, M.D., executive vice president, medical affairs, Mississippi Valley Regional Blood Center. "The PRISM instrument is a completely closed system so there is very little, if any, chance for operator errors during sample processing."
A hepatitis B test, PRISM® HBcore, is the first test approved by the U.S. Food and Drug Administration (FDA) for use on the PRISM system. Additional hepatitis and retrovirus screening tests, which includes a test for HIV, are currently under FDA review. Abbott also has other PRISM assays in development.
According to the American Association of Blood Banks (AABB), approximately eight million volunteers donate about 15 million units of whole blood each year. Each donated unit of blood is tested for infectious diseases including hepatitis, HIV and other retroviruses.
On any given day, approximately 38,000 units of red blood cells are needed. Donated blood is used to treat accident victims, people undergoing surgery and patients receiving treatment for leukemia, cancer or other diseases such as sickle cell disease and thalassemia.
About Abbott PRISM System
Fast and efficient, the PRISM system can run 160 samples per hour or up to 800 tests, making it possible to test more than 1,200 samples per eight hour shift. Numerous safety features built into the system help track and monitor each sample throughout the testing process providing documentation and quality control for testing facilities. Additionally, PRISM's testing methodology, Chemiluminescent Immunoassay (ChLIA), allows the system to better detect infectious agents or antibodies which may be present in a sample.
About Abbott
Abbott is a leader in ensuring the safety of the world's blood supply. In 1985, Abbott developed the world's first HIV blood screening test. Concentrating efforts in hepatitis and retrovirus detection, Abbott continues to set the standards of excellence in blood screening.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 60,000 people and markets its products in more than 130 countries.
abbott.com/news
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2 Patients Battle AHCCCS over Treatment Denial
SourceURL:http://www.dailystar.com
By Howard Fischer
CAPITOL MEDIA SERVICES
PHOENIX - Two people who will die without certain medical treatments are challenging the state's indigent health-care system for refusing to provide that care.
In one case, the Arizona Health Care Cost Containment System denied a liver transplant to a 49-year-old Phoenix woman solely because she has HIV. That follows a written AHCCCS policy saying those infected with the virus are ineligible for state-financed transplants.
The other case involves a 3-year-old girl with a rare form of eye cancer. AHCCCS has refused to pay for a procedure using the child's own stem cells, saying the state health-insurance program does not cover experimental treatments.
In both cases, attorneys for the patients say AHCCCS policies ignore medical evidence.
AHCCCS spokeswoman Elizabeth Olson said she can't discuss individual cases because of patient privacy concerns. But Olson said the state is simply following policies.
In the first case, Brenda Gwin was diagnosed with end-stage liver disease, the result, according to attorney Jen Stinton, of hepatitis C. By June, her doctors determined she met the criteria for a liver transplant.
But Stinton said the request for AHCCCS funding was rejected solely because of HIV. She said that is not only unfair but medically wrong.
"There is no valid scientific evidence that indicates that people who have HIV fare any worse than anyone else who needs an organ transplant," Stinton said. She cited a 2003 Johns Hopkins Medical Center report that noted the one-year survival rate for HIV-infected liver-transplant recipients is more than 80 percent - only about 5 percentage points below the average for all patients.
The other issue deals with a different AHCCCS policy, barring the use of state dollars for experimental treatments. That is defined as any for which there have not been peer-reviewed medical studies.
But attorney Jennifer Nye said that condemns 3-year-old Linda Moreno to death because there are fewer than 15 people a year in the whole country who contract this specific type of cancer, too few to have the kind of clinical trials necessary.
Nye said doctors believe the process, which involves harvesting stem cells from Linda's blood and reinjecting them, is the girl's only chance of being cured.
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Hepatitis-C Virus Stopped from Multiplying
SourceURL:http://www.rednova.com
A Japanese research team says it has found a method that prevents the hepatitis-C virus from multiplying.
The method deals with cells infected with the virus, not the virus itself, meaning drugs could be developed to stop the multiplication process while preventing the virus from becoming resistant, the researchers said.
It is still unknown how hepatitis-C virus multiplies once inside infected cells. But researchers know once the virus enters the cell, it develops a platform for multiplication by combining itself with a certain lipid, an organic compound.
Masayuki Sudo and colleagues at the Chugai Pharmaceutal Co. in Tokyo used the lipid to pinpoint the platform inside cells where the HCV had combined itself with the lipid. Without the platform, the HCV is unable to duplicate itself, the researchers said.
Using human liver cells, the team added a substance to the lipid that prevented it from combining with the HCV. Thus, the platform for multiplication could not synthesize, the researchers said.
If we can target the mechanism of virus-infected cells, it could prompt the development of more effective drugs, Sudo said.
The team's report appears on the Web site of the journal Nature Chemical Biology.
Source: United Press International
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Eli Lilly Expands Cymbalta Liver Warning--US FDA
SourceURL:http://news.yahoo.com
WASHINGTON (Reuters) - Eli Lilly and Co. has expanded its warning about possible liver-related problems with its depression drug, Cymbalta, and cautioned doctors against its use in chronic liver disease patients, U.S. health regulators said on Monday.
A new label for the antidepressant, known generically as duloxetine, also includes reports of hepatitis, jaundice and other liver-related problems in patients using the drug, the U.S. Food and Drug Administration
"Some of these reports indicate that patients with preexisting liver disease who take duloxetine may have an increased risk for further liver damage," the company said in letter to doctors dated October 5.
Cymbalta, which is also approved to treat a type of nerve damage caused by diabetes, has been known to cause liver problems. The label earlier warned against using the drug with alcohol.
"Cymbalta should ordinarily not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease," according to the new label, which was also posted online.
A spokeswoman for the drugmaker could not be immediately reached for comment.
The letter and new label are posted online at http://www.fda.gov/medwatch/safety
/2005/safety05.htm#Cymbalta.
Lilly shares fell $1.04, or 2 percent, to $51.58 in afternoon trade on the New York Stock Exchange
New York Stock Exchange. The American Stock Exchange Pharmaceutical Index of large U.S. and European drugmakers was off 1.1 percent.
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October 18th, 2005
Low Morbidity with Right Hepatectomy in Living Donors
SourceURL:http://www.gastrohep.com
With careful donor selection and specialized patient care, low morbidity rates can be achieved after right hepatectomy for living donor liver transplantation, finds the latest issue of the American Journal of Transplantation.
The shortage of deceased organ donors has created a need for right lobe living donor liver transplantation in adults.
Concerns regarding donor safety, however, necessitate continuous assessment of donor acceptance criteria and documentation of donor morbidity.
Dr Mark Cattral and colleagues report on the outcomes of the first 101 donors who underwent right lobectomy between 2000 and 2004.
The cohort comprised 58 men and 43 women with a median age of 38 years and a median follow-up of 24 months.
The middle hepatic vein was taken with the graft in 55 donors.
The overall morbidity rate was 37% – American Journal of Transplantation
The research team recorded all complications prospectively and stratified them by grade according to Clavien's classification.
The team noted that the overall morbidity rate was 37%.
All complications were either grade 1 or 2, and the majority occurred during the first 30 days after surgery.
The research team observed that the removal of the middle hepatic vein did not affect morbidity rate.
There were significantly fewer complications in the later half of our experience.
The researchers reported that all donors are well and have returned to full activities.
Dr Cattral's team concludes, "With careful donor selection and specialized patient care, low morbidity rates can be achieved after right hepatectomy for living donor liver transplantation."
Am J Transplant 2005: 5(11): 2764
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Viral Hepatitis Conference to Take Place February 27-28, 2006 in Boston, MA
SourceURL:http://biz.yahoo.com
BOSTON, Oct. 18 /PRNewswire/ -- Chronic hepatitis C (HCV) and B (HBV) are the most common causes of chronic viral hepatitis in the United States, posing serious risks for long-term medical complications, especially if left untreated. HBV affects over 2 billion people in the world today while HCV affects approximately 4 million people each year. Strategic Research Institute announces the "2nd Annual Viral Hepatitis Drug Discovery & Development Summit" scheduled to take place February 27-28, 2006 in Boston, MA.
By attending this industrial and networking conference you will be able to interact with many of the leading research scientists and decision-makers from the pharmaceutical/biotech industry, public health, and academic communities working in the area of viral hepatitis of North America and internationally. The conference will focus primarily on Hepatitis C Virus and Hepatitis B Virus topics. Some of the topics covered include nucleoside and non-nucleoside polymerase inhibitors, protease inhibitors, other antiviral initiatives such as direct antiviral and immune approaches, HCV vaccines, etc.
To request a copy of the conference agenda, please contact the conference organizer Glenn Pascual of Strategic Research Institute at gpascual@srinstitute.com or 212.967.0095, ext. 245. Please include full contact information.
To become a media partner, please contact Cheryl-Kahan Radhuber at ckahan-radhuber@srinstitute.com.
For more information on sponsorship & exhibition opportunities, please contact Glenn Pascual at gpascual@srinstitute.com.
Source: Strategic Research Institute
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October 19th, 2005
Foes: Amendment Hurts Partner Benefits
SourceURL:http://www.tucsoncitizen.com
PHOENIX - Amy Price says she and her partner, Kathy Hopkins, struggled to afford the $600 to $700 monthly cost of Hopkins' hepatitis C medication when Hopkins was covered by her private employer's health plan.
"It was going to break us," Price said. "It was just an astronomical amount."
If there's ever another need for that kind of treatment, the cost will be much less now that Hopkins receives domestic-partner health-care benefits through Price's job as a radio installer for the city of Phoenix.
But whether Phoenix and other local governments in Arizona would be able to continue to provide benefits to couples such as Price and Hopkins is an early focus of debate concerning a proposed state constitutional amendment to define marriage as a union between one man and one woman.
Opponents of the Protect Marriage Amendment proposed for Arizona's November 2006 ballot say employees and partners would lose their partner benefits under wording that prohibits the state and local governments from granting marriage-like "legal status" to unmarried people.
Arizona governments providing medical benefits to domestic partners include Pima County, Pima Community College, the Sunnyside and Tucson unified school districts and the cities of Phoenix, Scottsdale, Tempe and Tucson.
Initiative supporters say the domestic partner issue is a smoke screen and that the proposed 58-word measure is solely intended to protect marriage. They say the "legal status" language is meant to keep activist judges from legalizing civil unions.
"What we can say at this point is that the amendment is to identify and define marriage as between one man and one woman," said Nathan Sproul, a consultant for the initiative campaign. "That is all that this is trying to accomplish."
While some Protect Marriage Arizona supporters previously said domestic partner benefits provided by governments would be prohibited, Sproul declined to explicitly state during an interview whether the amendment would affect those benefits.
"Ultimately that's going to have to be up to the judicial system to figure out what the implications of the definition are," said Sproul, a Republican political operative recently hired by the initiative campaign.
However, United Families Arizona, a group belonging to the pro-amendment coalition, flatly said government-provided benefits for domestic partners would not be affected because they stem from employment, not marriage.
Arizona Together, a coalition opposing the initiative, is focusing much of its early efforts on the domestic-partner benefits issue.
Accordingly, coalition members welcomed a recent Arizona State University poll that found strong opposition among registered Arizona voters toward the initiative and a ban on domestic-partner benefits offered by state and local governments.
A big majority said they would oppose an amendment that would ban both same-sex marriages and domestic-partner benefits for unmarried government employees.
A large number also said they would oppose a ban on just domestic-partners benefits.
"That's the part that people don't like because people don't want to hurt people and take away their existing benefits," said state Rep. Kyrsten Sinema, a Phoenix Democrat and chairwoman of Arizona Together. "I think I give a speech about this every single day."
PROPOSED AMMENDMENT
TEXT OF PROPOSED AMENDMENT: "To preserve and protect marriage in this state, only a union between one man and one woman shall be valid or recognized as a marriage by this state or its political subdivisions and no legal status for unmarried persons shall be created or recognized by this state or its political subdivisions that is similar to that of marriage."
SIGNATURE REQUIREMENT: Supporters need to file the signatures of at least 183,917 registered voters by July 6 to qualify the initiative for the November 2006 state ballot.
DOMESTIC PARTNER BENEFITS: Local governments providing medical benefits to domestic partners include Pima County, Pima Community College, the Sunnyside and Tucson unified school districts and the cities of Phoenix, Scottsdale, Tempe and Tucson.
OTHER STATES: Marriage amendments were approved by all 11 states where such measures were on the November 2004 ballot: Arkansas, Georgia, Kentucky, Michigan, Mississippi, Montana, North Dakota, Oklahoma, Ohio, Oregon and Utah. A measure similar to the one approved by Ohio and proposed in Arizona is on this November's ballot in Texas.
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Georgia Woman's Personal Journey Brings Her to W-B
http://www.citizensvoice.com/
By Denise Allabaugh, Staff Writer
Deborah Simone, who has walked and bicycled more than 9,000 miles in her effort to educate the public about hepatitis C, pedaled through Wilkes-Barre Wednesday.
For Simone, it's personal. Her husband, Paul, died last year after a 25-year battle with the disease.
Simone, a 44-year-old Augusta, Ga., resident, carries a 20-pound pack containing pamphlets about hepatitis C, a chronic viral disease of the liver that infests about 5 million people in the United States each year.
"This is a national issue. This is a global issue. It is a growing epidemic, and it is one of the most underpublicized health issues of our time," Simone said. "When you're not a celebrity or a household name, you have to go through extreme measures to spotlight a disease."
Pennsylvania marked the 38th state Simone visited since she and her late husband started their public awareness campaign in 2002.
Her late husband contracted the disease from a blood transfusion during a surgical procedure in 1979. It began to take a devastating toll on his health in 1993, Simone said.
Simone's husband died Nov. 12, 2004, one day after their 12th anniversary. She continued their mission alone. The journey has had its share of ups and downs.
"I broke my back and couldn't walk long distances anymore, so I'm finishing the job on my bike. I had thrills and spills. I wiped out coming out of Ohio. I hit gravel and it banged me up pretty bad," Simone said. "Slowly but surely, I will get the job done."
Simone's goal is to continue through 48 states and end her journey in Washington D.C., where she hopes to convince senators about the need for more public information about hepatitis C.
According to information she presented from the Centers for Disease Control, hepatitis C can cause cirrhosis, liver failure and liver cancer. It is the leading cause of liver transplantation in the United States and accounts for 8,000 to 12,000 deaths each year. There is no vaccination against hepatitis C and there is no cure.
"The number of people that are going to be infected in the next 10 to 15 years is going to triple," Simone said. "I want people to be aware of the risks involved with the disease and the need to be tested."
The most common modes of transmission for hepatitis C are IV drug use, cocaine use, needle-stick injuries, tattooing, body piercing and manicures, she said.
Simone is the president of the non-profit organization Journey of Hope. Its mission is to significantly impact the progression of hepatitis C through public education.
She and her late husband sold their home to purchase a recreational vehicle to aid them with their public awareness campaign.
"I will do everything in my power to try to combat this disease," Simone said. "I'm fortunate people were placed in my path who have come to my rescue and who have urged me to continue."
dallabaugh@citizensvoice.com
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Proposal Allowing Pharmacies to Sell Needles Rejected
SourceURL:http://www.sanluisobispo.com
SACRAMENTO, Calif. - Sacramento County supervisors have rejected a proposal that would allow pharmacies to sell adults hypodermic needles without prescriptions.
A new law allows pharmacies to sell as many as 10 needles at a time to adults, but only if the local government approves the program.
The board voted 3-2 Tuesday to reject the plan. The vote followed testimony by several health officials, including the county's public health officer, who said allowing needle sales without a prescription would reduce the transmission of diseases such as HIV and hepatitis C among drug users.
Law enforcement officials had asked the county to reject the proposal. They said it would lead to more discarded needles, which would put the public at risk.
"We can do better than this program," Supervisor Roberta MacGlashan said.
Supervisor Roger Dickinson disagreed, noting that having clean needles available would decrease the spread of disease. He said he didn't believe that allowing addicts to buy needles would encourage illicit drug use.
"When we say each and every day that we value life but we refuse to take steps that can save lives, what is the mixed message then?" he asked.
A dozen California counties have approved needle sales without a prescription, according to the state Department of Health Services.
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October 21st, 2005
Par's Generic Copegus Gets Tentative OK
SourceURL:http://biz.yahoo.com
Par Says FDA Grants Tentative Approval to Generic Version of Roche Hepatitis C Drug
SPRING VALLEY, N.Y. (AP) -- Par Pharmaceutical Cos. said Thursday that the Food and Drug Administration granted tentative approval to its generic version of a hepatitis C treatment sold by Roche Holding Ltd. under the Copegus brand.
The FDA grants tentative approvals to drugs that it cannot immediately approve because of existing patents or exclusive selling rights for similar products. Par said it expects final approval for the tablets after Roche's exclusivity expires on Dec. 3.
Par and partner Three Rivers Pharmaceuticals have agreed to co-market the product, which it will sell in 200 milligram, 400 milligram and 600 milligram doses.
Par shares closed earlier down 47 cents at $23.38 on the New York Stock Exchange.
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MultiCell and Thomas Jefferson University to Study Potential Hepatitis C Treatment
SourceURL:http://www.masshightech.com
MultiCell Technologies Inc. has entered into a research collaboration with Thomas Jefferson University, a medical and health sciences university in Philadelphia, to evaluate the company's immortalized human liver cells as model systems to identify new drugs to treat hepatitis C viral (HCV) infection.
No financial details of the collaboration deal were announced.
There are an estimated 170 million people chronically infected with HCV (hepatitis C virus) worldwide who are at high risk for the development of chronic hepatitis, cirrhosis, and liver cancer, according to officials from Lincoln, R.I.-based MultiCell. The lack of cell-based models capable of supporting infection and replication of HCV has hampered the identification of new drugs to treat HCV related diseases.
According to MultiCell's chief science officer, Ron Faris, the studies will lead to the development of new high speed drug testing kits to screen for antiviral drugs using the company's proprietary immortalized human liver cells.
MultiCell Technologies stock, which trades on the Over the Counter Bulletin Board, was selling at mid-morning for 50 cents, unchanged from its close yesterday.
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Past Illegal Blood Donation in China Linked to Hepatitis C Virus Infection
SourceURL:http://www.docguide.com
ALEXANDRIA, VA -- October 20, 2005 -- Research in a rural province of central China has documented that illegal blood donation practices led to high hepatitis C virus (HCV) infection rates in blood and plasma donors during the 1980s and early 1990s, and that failure to screen for HCV in transfusion recipients increased their risk of infection as well, according to an article in the November 15 issue of The Journal of Infectious Diseases, now available online.
Some blood donation facilities in rural China illegally pooled blood and reinfused compatible red blood cells to permit more frequent donations. Although government action has markedly curtailed such practices since the late 1990s, blood collection and banking methods in such settings still need to be monitored and improved, the article noted.
Researchers from the United States and China, including Han-zhu Qian, MD, PhD, of the University of Alabama at Birmingham, conducted a survey in 2003 among a random sample of 538 adult residents from 12 former commercial plasma-donating villages in Shanxi Province.
Structured questionnaires were administered and blood samples tested for HCV antibodies. HCV rates were 8% in all participants, 28% in former plasma/blood donors, and about 3% in non-donors. Selling blood or plasma was the strongest independent predictor for HCV-positive findings. Receiving a blood transfusion was also independently associated with HCV; villagers who received blood transfusion had about 8 times the risk of HCV infection than those who had no history of blood transfusion.
Among the 538 villagers, 22% had a history of selling blood or plasma; from village to village, the rates ranged from 9% to 49%. The most common reasons for the practice were a need for money and being talked into it by other people. Villagers began to sell blood as early as in 1973 and as late as 1998; the main reasons for stopping were improved economic status, concern about health effects of blood drawing, abnormal liver function tests or hepatitis, and shut-down of the illegal blood center.
The investigators concluded that unhygienic plasma donation and receipt of blood transfusion are strong risk factors for HCV infection in rural central China, and that improved blood collection and blood banking practices remain an urgent health priority. "Technical support and drugs are needed to assist these central Chinese provinces cope with the care and treatment needs of HCV patients," the investigators added.
In an accompanying editorial, Roger Y. Dodd, PhD, of the American Red Cross noted that the study is "a snapshot of past events and should not be taken to define the present circumstances." Nevertheless, it illustrates that "short cuts, shoddy practice, pursuit of the bottom line, and lack of oversight can have devastating outcomes, not only for patients but also for donors."
SOURCE: Infectious Diseases Society of America
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Hepatitis C Found More Frequently in Semen of Men Coinfected with HIV/HCV
http://www.aidsmap.com
Hepatitis C virus is found significantly more frequently in the semen of men who are coinfected with HIV than in the semen of men who are only infected with hepatitis C (HCV), according to research published in the November 4th edition of AIDS. Sexual transmission of hepatitis C virus has recently been observed in HIV-positive gay men and the investigators write, “our results partly illustrate how the recent increase in sexually transmitted hepatitis C virus in homosexual men could arise.”
The investigators also found that hepatitis C virus in semen originated in the blood with no evidence of hepatitis C replication in the genitals.
Sexual transmission of hepatitis C is a controversial subject. There is little evidence of transmission of the virus between heterosexual couples and large studies involving HIV-negative gay men have failed to find any evidence of sexual transmission of hepatitis C. In recent years there have been a number of studies reporting sexual transmission of hepatitis C amongst HIV-positive gay men, with evidence from the UK, Switzerland and France suggesting that unprotected anal sex, concurrent sexually transmitted infections, and “hard” sex which may involve trauma are risk factors.
To further understand the sexual transmission of hepatitis C, French investigators compared the prevalence of hepatitis C virus in the semen of men who were coinfected with HIV and hepatitis C virus and men who were infected only with hepatitis C. They also wished to see if hepatitis C was reproducing in the genital tract of men.
A total of 120 men with hepatitis C were included in the investigators’ analysis. In addition to being infected with hepatitis C, 82 of the men were also HIV-positive.
Paired blood and semen samples were obtained from each of the men. Repeat semen samples were obtained from 45 men (35 of whom were coinfected). The blood and semen samples were tested for hepatitis C viral load.
None of the men were receiving anti-hepatitis C treatment. The HIV-positive individuals had a median CD4 cell count of 524 cells and a median viral load of below 50 copies/ml. All but seven HIV-positive patients were taking antiretroviral therapy.
A total of 191 semen samples were tested for hepatitis C and overall 27% were positive. In all, 32% of men provided at least one semen sample which was positive for hepatitis C.
Hepatitis C was detected with significantly greater frequency in the semen of HIV-positive men (38%) than HIV-negative men (18%, p = 0.033).
Amongst the HIV-positive men, neither CD4 cell count nor viral load were significantly associated with having detectable hepatitis C in semen.
Blood samples tested positive for hepatitis C in all 120 men. The investigators found that men who had detectable hepatitis C in their semen had hepatitis C viral loads in their blood. This difference was statistically significant for coinfected men (median 6.22 log10IU/ml versus 5.95 log10IU/ml, p = 0.038).
Samples of blood and semen were further studies in two men (one HIV-positive and one HIV-negative) to see if there was any evidence of hepatitis C reproduction in the genitals. No evidence was found of hepatitis C replication in the genitals with hepatitis C in semen being genetically similar to hepatitis C in the blood.
“In this study, hepatitis C virus RNA was more frequently found in the semen of HIV/hepatitis C virus coinfected men than in the semen of non-coinfected men”, write the investigators. They note that even in men who had hepatitis C in their semen, detection of the virus was intermittent and “close to the detection threshold.”
The investigators also observe that hepatitis C viral load was higher in the blood of coinfected men than in HIV-negative men (p = 0.017) and they believe that “this may partly explain why the coinfected men had a higher prevalence of hepatitis C in their semen.”
Rather than reproducing in the genitals, the investigators believe that hepatitis C was “transferring” between blood and semen.
Reference
Briat A et al. Hepatitis C virus in the semen of men coinfected with HIV-1: prevalence and origin. AIDS 19: 1827 1853, 2005.
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Lawsuit Takes State Prisons to Task for Hepatitis C Treatment
SourceURL:http://www.macon.com/
By Don Schanche Jr. TELEGRAPH STAFF WRITER
In April 2001, prison inmate Winston K. Goforth tested positive for hepatitis C. Despite his repeated requests for treatment, it was two years before state prison officials ordered a liver biopsy to determine the progression of his illness, according to a complaint filed in federal court.
A prison system gastroenterologist prescribed an expensive drug to treat his disease, a viral infection of the liver that can be fatal. But the prison system's medical director countermanded the decision, according to the complaint.
To this day, according to his suit, Goforth has received no other treatment besides periodic blood tests. And his time may be running out.
"This is an action to compel the Georgia Department of Corrections to provide Mr. Goforth with adequate treatment, without which he may suffer further liver damage and die," his lawsuit says.
Sarah Geraghty, a staff attorney for the Atlanta-based Southern Center for Human Rights, said the center has heard from numerous prison inmates like Goforth who have been denied treatment for hepatitis C. And those people are not going to leave their disease behind when they get out of prison, she said.
"The uncontrolled hepatitis C within the prison system is not just going to affect people in prison," Geraghty said. "It's going to affect everybody. Almost everybody who comes into prison is going to get out of prison."
State prison officials say about 2,800 inmates have been diagnosed with hepatitis C. But testing is voluntary, so the total number of cases is unknown.
"Consequently, descriptions on whether the disease prevalence is increasing, stable or decreasing are only estimates. The hepatitis C prevalence appears stable at this time," Department of Corrections spokeswoman Peggy Chapman said in an e-mail.
She declined to comment on Goforth's suit because it is pending litigation. In a court filing, the Department of Corrections said Goforth's medical treatment in prison was "reasonable and proper."
Goforth, serving a 10-year drug sentence at Men's State Prison in Hardwick, filed a pauper's lawsuit in March 2002 in U.S. District Court in Macon to force the state to treat him. He got nowhere until this year, when the 11th U.S. Circuit Court of Appeals ruled that he had been denied access to his medical records. In May, the Southern Center took on his case. Last week, U.S. Magistrate Claude Hicks reopened the discovery process, allowing lawyers to take depositions and examine the medical records.
"(Goforth) contacted us at a time when we were investigating the treatment provided by the Georgia Department of Corrections for this particular illness," Geraghty said.
Prisons spokeswoman Chapman said via e-mail that hepatitis C treatments are about 40 percent effective, and the strain of hepatitis C prevalent in Georgia prisons is highly resistant to treatment.
"The consequence of these medical facts is that practitioners must consider the odds very carefully with their patients, balancing the likelihood of a failure versus the possibility of ongoing liver damage for untreated patients," she said. "Treatment is offered to those with disease sufficiently advanced to warrant a try with the imperfect therapies available today and who have sufficient time left in their sentence to complete the treatment and follow up testing."
Goforth's suit contends that prison officials denied him treatment because he has cirrhosis, a liver disorder. But his lawyer said his cirrhosis has not progressed to the point where treatment would no longer help.
She also cited a Federal Bureau of Prisons guideline that says hepatitis C patients with cirrhosis should be considered "priority candidates for treatment."
Goforth's suit also says he was denied because officials said he may be paroled before the treatment is up.
Madie Lamarre, a nurse practitioner and former clinical services manager in the office of health services for the Georgia prison system, said hepatitis C is one of several diseases that typically shows up at a higher-than-normal rate in prison.
She said hepatitis C is spread by blood-to-blood contact. Among drug abusers, who represent a large percentage of prison inmates, that typically stems from shared hypodermic needles. Inside prison, she said, hepatitis C is commonly spread when inmates get tattoos. She also said as many as 25 percent of people who get hepatitis C get rid of the infection on their own without treatment. Eight out of 10 people with hepatitis C do not develop cirrhosis.
"As a general comment, prisons house people with a much higher incidence of communicable diseases than is in the general population," Lamarre said. "That's well-documented. If the prison systems don't do a good job of controlling communicable diseases in prison, most inmates are released to the community, and it increases the risk to the public health. That's why it's very important that prison systems all over the United States cooperate and collaborate with public health to do things to take steps to reduce the risk of communicable diseases in prison.
"I think the Georgia Department of Corrections historically has done pretty well at collaborating with public health, but there's a lot more to be done."
She said prison systems should consider providing sterile settings for prisoners to do their tattooing. She also said the spread of hepatitis B and HIV could be slowed if prisons acknowledged the reality of prison sex, and distributed condoms.
"It's been done in other states," she said. "It's done in Europe, it's done in Australia, it's done in Canada. It should be done because it's the right thing to do for public health. People get upset because they think it's about condoning sex. That's not what it's about. It's the right thing to do for protecting public health."
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