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Week Ending: September 8th , 2007
Alan Franciscus
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This Issue:
September 1st, 2007
Compensate 'poisoned blood' victims plea
http://www.theboltonnews.co.uk/
By Jeremy Peel
A FATHER who almost died after being given contaminated blood products while being treated for his haemophilia on the NHS is supporting calls for compensation for the thousands of other victims.
David Fielding, aged 51, of Darley Avenue, Farnworth, spoke out after attending the Archer Independent Public Inquiry.
The inquiry is examining the deaths of 1,757 haemophiliacs as a result of exposure the HIV and Hepatitis C.
The inquiry into what has been dubbed the worst treatment disaster in the NHS this week heard how thousands of haemophiliacs were allowed to continue with their treatment in the 1970s and 80s, despite medics being aware it could put them at risk of AIDS.
In light of these revelations, the Haemophilia Society is calling for the Government to compensate the thousands of people and their families affected.
Mr Fielding, who contracted Hepatitis C after being given contaminated blood products, said: "I was a watch and clock repairer, but I was forced to give up work when my liver started to fail.
"As a family, we had to scrimp and save and I have always wanted to work, but was unable to because of what the NHS did to me.
"My children suffered because of this and there are thousands of people who have suffered financial hardship over the years."
Mr Fielding was diagnosed with Hepatitis C after he received tainted blood in 1990.
His condition was diagnosed in 1998, when he was told he had just six months to live unless he received a liver transplant, which he was finally given when he was just days away from death.
But his brother, Brian, was also a haemophiliac and died from an AIDS-related illness after he contracted the virus while being treated for his blood clotting disorder.
In addition to compensation, Mr Fielding is also demanding a formal apology from the Government.
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A tiny cut turns into a close call
http://www.latimes.com
By Linda Reid Chassiakos, Special to The Times
When a doctor gets a needle-prick -- even a tiny one, from a low-risk patient -- it can't be ignored.
My patient's laceration was relatively easy to suture. Only one layer of stitches would be needed, and I could have him on his way in less than 20 minutes. My years working in the emergency room had made me comfortable with minor injuries; the repair looked good, and the scarring would probably be minimal.
I had just come back from maternity leave, and it was nice to be back in the saddle, working at my craft once again. I cleaned and dressed my patient's wound, gave him a tetanus booster, then shook his hand and asked him to return in two to three days for a follow-up to check the healing.
My next patient was waiting, so I quickly gathered the drapes, leftover suture, needles, forceps and other detritus in the exam room to move them to the biohazard bin near the sink. I paid careful attention to avoid contaminating patient areas with blood-borne pathogens such as HIV and hepatitis B and C. Infected blood could transmit the viruses to another patient through mucous membranes or cut skin.
As I picked up the bundle of materials, I heard a clatter and felt a pinch on the top of my foot. I looked down and saw that the sharp scissors I had used to trim the edge of my patient's laceration had bounced off a bare patch on my foot just beyond the edge of my closed-toe shoe.
My initial reaction was irritation. I placed the rest of my package in the cleanup area and came back and picked up the scissors.
I noted -- now with alarm -- that the tips were stained by moist blood. A glance at my foot showed a small amount of bleeding at the puncture site. It was clear that most of the blood on the scissors had been my patient's. There was a small chance that, as they broke my skin, the blades could have infected me with a virus that could cause hepatitis or AIDS.
There were patient charts stacking up in my in-box. I tried to downplay the incident to myself. After all, I had completed my series of hepatitis B vaccinations, my patient was unlikely to have one of these viruses, the almost-dried blood on the scissors was probably no longer contagious, the exposure on my foot was too shallow and too limited to truly be a risk, my own bleeding would wash out any possible contaminants. . . .
Shrugging my shoulders, I intended to continue with my schedule as if nothing had happened. Until the next instant, when I remembered that I was breast-feeding. Any blood-borne infection I might conceivably catch would put not only me but also my baby son at risk. The virus could then be passed on to my child through my breast milk.
Additionally, if I were to get HIV or hepatitis C, God forbid, it would be critical to be aware of my health status and to take precautions to avoid the low risk of passing on the infection to my family -- or patients.
I laid down my charts with a sigh. There was no other choice: I would have to report the incident and get a risk assessment and an infection evaluation -- and my patient would have to get one too. I would also have to, hopefully temporarily, pause breast-feeding until I could be sure that I was not infected and that I didn't need preventive treatment with the antiviral agent AZT.
A recent study in the New England Journal of Medicine reported that more than 80% of surgeons in training had had needle-stick injuries, more than half of which involved patients at high risk of being infected with HIV or a hepatitis virus. However, 51% of these incidents -- 16% involving high-risk patients -- were not reported.
The reason most often given -- lack of time -- was certainly a concern for me. But embarrassment, denial and the often underestimated perception of a patient's risk were also significant excuses -- and ones that had crossed my mind as well.
Asking a colleague to fill in until I returned to my clinic, I rushed to our employee health facility and began the evaluation and laboratory tests needed to establish my baseline status regarding HIV and hepatitis.
We also contacted my patient and asked him to come in for screening tests that could determine if he was infected with blood-borne pathogens.
He was understandably annoyed at the inconvenience but cooperative. To my relief, he provided us with information about his personal and medical history that indicated he was not likely to have been exposed or infected by hepatitis or HIV.
Aware that patient reports may not always be accurate, I weighed the pros and cons of post-exposure prophylaxis (preventive treatment) with AZT and finally opted not to begin the antiviral medicine.
However, until the confirmatory laboratory tests came back a couple of days later, I did use breast milk for my son that I had pumped and frozen before my injury.
To my relief, the tests showed that my patient was not infected with these pathogens. -- as did my own lab results over the ensuing weeks.
I was grateful for the reassuring outcome -- but my scenario is repeated in examination and procedure rooms, operating suites and other healthcare sites every day, often in riskier situations and, sometimes, sadly, with less fortunate results.
At our center, doctors and nurses who are injured by needles or other bloody objects are required to go to an occupational health provider that offers supportive evaluations and preventive treatment.
We also provide regular educational programs that stress the importance of precautions to prevent injury and describe the necessary steps to reduce risk in case of a mishap.
Educating health professionals about the importance of reporting potentially infectious injuries should be part of the baseline of healthcare.
Accidents happen, and reporting the incident, getting an evaluation and, if appropriate, taking post-exposure preventive treatment, are actions we not only owe to ourselves but also to our patients.
Dr. Linda Reid Chassiakos is director of the Klotz Student Health Center at Cal State Northridge and a clinical assistant professor of pediatrics at UCLA.
If you work in the health/ medical field and have a story to tell or point of view to share about your work, e-mail your submission (750 words or fewer) to health@latimes.com.
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Hepatitis increase linked to better data
http://www.buffalonews.com/
By Mark Sommer
NEWS STAFF REPORTER
An additional 190 cases of hepatitis C reported last year in Erie County, but health officials caution it may reflect better tracking.
The state began requiring physicians and medical laboratories to report cases of the infectious disease in 2003.
Determining when the disease actually is contracted can be difficult, since carriers often have it for years before detection.
Of the 866 people with hepatitis C in the county, only nine were considered to have been newly infected, according to county health records.
Sixty involved people under the age of 30.
“It could mean people are testing more, becoming more aware of the infection and that more services are being offered to people at risk,” said Heather Lindstrom, an epidemiologist with the county Health Department.
Dr. Anthony Billittier IV, county health commissioner, said the disease mainly is transmitted by dirty needles for intravenous drug use, especially for people younger than 30.
“We know people are going to use drugs, and we need people to stop doing that. But as an intermediate step, we need to at least get them to use clean needles and not share them,” Billittier said.
He said the Health Department is trying to create neighborhood opportunities for drug users to obtain clean needles. Lack of funds limit the programs now in operation, he said.
The increase in reported cases, he added, did not surprise the department.
“It’s not a revelation for us in public health, but I’m hoping it really is a wake-up call for the community,” Billittier said.
msommer@buffnews.com
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Mercy patients fear infection
http://www.gazetteextra.com
By Gina Duwe
gduwe@gazetteextra.com
Wisconsin -- A 79-year-old area woman expected her colonoscopy in April to be routine. Now she's left for months wondering if she might get AIDS or hepatitis.
Mercy Hospital might have exposed the woman and a handful of other patients to HIV and hepatitis by not replacing a colonoscopy scope valve between patients, several patients told The Janesville Gazette.
In a letter to one of the patients obtained by the Gazette, Valerie Johns, vice president of daily operations, wrote: "You recently had a colonoscopy procedure at Mercy Hospital. Following the procedure, we learned that a piece of equipment involved in your procedure may not have been used entirely in accordance with manufacturer's instructions.
"As we explained to you in our telephone calls, there is an extremely small chance that this could pose a risk to your health; the chance is quite remote-less than one in a million," Johns wrote in the letter to Dawn Bowlen of Beloit.
Bowlen said she had a colonoscopy in the spring.
When contacted by the Gazette, Mercy Hospital neither confirmed nor denied the incident, but Johns said in a written statement that a "small number of patients were involved in this situation."
"We know precisely who they are, and we have talked with each of them about the matter," she said in the statement. "Despite the low risk, in an abundance of caution, we elected to follow a testing protocol, at our cost, to eliminate any doubt about health risks."
In her letter to Bowlen, however, Johns described the procedure, saying that tubes and a valve attached to the colonoscopy scope carry liquid a doctor may use as an "irrigation agent" during the procedure.
"Following each colonoscopy, the manufacturer recommends that one of the tubes be discarded, and this was done in your case," Johns wrote in the letter.
"The manufacturer also recommends that the valve also be discarded. In your case, we believe this may not have been done. But as noted, even if the valve was not discarded, the risk to your health is negligible; less than one in a million," he wrote.
Bowlen said she had a colonoscopy in spring and was told of the situation over the phone.
"They told me this, and I broke down in tears," she said.
She went in for a blood test, which came up negative.
Bowlen said Johns told her she might have been exposed to HIV, hepatitis A, hepatitis B and hepatitis C.
She's frustrated, though, because she said doctors haven't contacted her to schedule more blood tests at three and six months like they said they would.
"I've never heard about any of mine," she said. "Obviously they dropped the ball on that."
When she pressed officials for information on how the possible exposure happened, she said "they weren't really forthright" and at first said they weren't comfortable giving her anything in writing. She later received a letter from Mercy documenting the incident, she said.
Mercy told her the problem resulted from a piece of equipment and a misunderstanding during in-service training, Bowlen said.
The probability of any of the patients having health effects is less than one in 1 million, Johns repeated in a statement to the Gazette.
"The risk to patients' health is extremely remote," she said.
But that doesn't stop the worry for the 79-year-old woman, who asked not to be identified because she fears she'll be treated differently by doctors.
"Well, I don't care," she said. "It's the six months that you worry about it, and your husband worries about it, and your family worries about it."
Three weeks after the woman'scolonoscopy, Mercy called her and requested she come in for blood tests, which she did. The situation was explained to her by an infectious disease doctor, and she had another blood test in July.
Her blood tests have been negative, and her last test is scheduled for October.
"We are confident that no patient will experience any adverse health effects," Johns said.
The 79-year-old woman has been talking with a lawyer and may sue after her tests are complete.
"I don't care if it is one in a million, one in a thousand," she said. "I could be that one."
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September 4th, 2007
Hepatitis E In Europe: Are Pigs Or Pork The Problem?
http://www.sciencedaily.com
Science Daily — Hepatitis E virus infections can be fatal in pregnant women, but until recently doctors thought the disease was confined to China, India and developing countries. Now Europeans are also contracting the disease here, according to scientists.
Hepatitis E virus is one of the few viruses which has been shown to be transmitted directly from animals through food. It was recently thought to be confined to developing countries, and although scientists are still unsure exactly how it spreads to people, direct contact with pigs or eating contaminated pork products is a likely route.
"If this proves to be a relevant route for pig to human infection for Hepatitis E in Europe, food safety regulations might need to be adapted accordingly," says Dutch researcher Erwin Duizer. "Where we do find Hepatitis E virus identified in Europe then the strain is usually closely related to the viruses found in pigs in the same country."
Far fewer cases of Hepatitis E virus are reported than actually occur, since doctors currently rarely ask for the relevant diagnostic tests in many industrialized countries. Although they do not yet know the exact route for most infections, the scientists do know that these viruses can infect people if they eat infected pig's livers without cooking them.
Genetic material from Hepatitis E viruses has already been detected in pig livers being offered for sale in Japan, USA and the Netherlands, proving that European pigs are in contact with Hepatitis E. Wild boar products could present a similar risk.
"To improve understanding of this disease, doctors should routinely start asking for Hepatitis E screening tests, even if the patient has not been travelling in India, China or other countries where they might expect to be at risk of infection" says Erwin Duizer. "Once more people are correctly diagnosed with viral Hepatitis E, they can be treated more effectively and we can learn more on the transmission routes. Current rates of diagnosis are up to13% of acute viral hepatitis patients in European countries, but we think the true rate is much higher. Up to 3% of blood donors in Europe show evidence of exposure to the virus through detectable antibodies."
"We also need to quickly work out the local route of infection in Europeans, as knowing if Hepatitis E is directly caused by eating pork meat or liver, or caused by foods or people being in contact with pig faeces, will make it possible to implement effective preventive measures", says Erwin Duizer.
Dr Duizer presented the paper 'Endemic HEV in Europe: prevalence and transmission' at 1445 on 03 September 2007 in the Microbial Infection Group session of the 161st Meeting of the Society for General Microbiology at the University of Edinburgh, 03 - 06 September 2007.
Note: This story has been adapted from a news release issued by Society for General Microbiology.
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Women face tests for hepatitis virus
http://www.spaldingtoday.co.uk
By Victoria Fear
BostonPilgrimHospital ... testing 62 former patients for hepatitis C.
SIXTEEN women from the Spalding area are being tested for hepatitis C after a gynaecologist with the virus was caught operating on a patient.
United Lincolnshire Hospitals NHS Trust is testing 62 women who were treated at Boston Pilgrim Hospital by consultant gynaecologist Ahmed Shaheen.
An investigation was launched into Dr Shaheen after medical staff blew the whistle when he breached guidelines by opening a woman's stomach in July – a procedure he is not allowed to do as a hepatitis C carrier.
He was diagnosed with the virus eight years ago after his patient Joan Bensley, of Thames Road, Spalding, developed hepatitis C after an operation and later died.
The Trust claims there is little chance of the virus being passed on.
George Gough, clinical director for women and children services, said: "I would say there is a very small chance of passing it on with the procedure he was doing and the precaution that he was taking.
"Not withstanding that, he should not have been doing these procedures."
Dr Shaheen's duties were restricted after being diagnosed in 1999 and the investigation will concentrate on the minor surgical procedures he has been conducting between 2000 and July 2007.
As a hepatitis C sufferer Dr Shaheen should not conduct Exposure Prone Procedures – those when the surgeon cannot see his fingers or hands at all times.
Fifty-nine women were treated for incontinence problems but Mr Gough said that the gynaecologist felt that by 'double gloving' it was not an EPP.
Trust deputy chief executive Paul Grant said: "It is worrying that this happened. It is important that we understand what has happened and how that came about."
The Trust says the results of the investigation will be made public and the General Medical Council has been informed.
More to this than they are admitting – patient
ONE of 62 women being recalled for testing says the episode has been handled badly.
The Holbeach woman wants to know facts and feared she was being tested for more than hepatitis C.
United Lincolnshire Hospitals Trust has assigned a team of nurses and counsellors to initially break the news to the women over the phone before being sent a letter.
The Holbeach woman, who is among 16 patients from the Spalding area, went along to Johnson Hospital in Spalding on Thursday for a test and is expecting the results this week.
She was informed by a telephone call the previous day and says that the caller was not prepared for some of her questions.
She said: "They were protecting themselves and I don't think it has been handled very well.
"They have rushed into it and organised it so well that it makes you wonder what is behind it all.
"I am not interested in having someone hold my hand all the time, I would rather have more facts."
The woman went into the Pilgrim Hospital for a bladder operation in 2001 and says she was one of the first people to receive this procedure.
She said she bears the consultant no ill will, describing him as "fantastic", but that this episode highlights the fact that surgeons also place their health at risk when operating.
A spokesman for the Trust has said that the women are only being tested for hepatitis C and added: "We are sorry that the patient is unhappy."
Hepatitis C: The Facts
- Hepatitis C is a blood-borne infection that can lead to liver disease.
- The most common way to get hepatitis C is through drug use. Sexual transmission is relatively rare.
- Some people clear the infection from their system naturally. Some sufferers never develop any symptoms while others can go on to have serious liver damage.
- Reported symptoms include tiredness, weight loss, nausea, abdominal pain and jaundice.
- Treatment of choice is by a combination of drugs, but not everyone can tolerate the effects.
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September 5th, 2007
HCV And HBV Spreading More Slowly Among Injection Drug Users In San Francisco
http://www.sciencedaily.com/
Science Daily — Injection drug users are still at a very high risk of acquiring hepatitis C (HCV) and hepatitis B (HBV); however, needle-sharing is less common, and users do not become infected as quickly as they did in the past, according to a new study.
Both HCV and HBV raise the risk of liver cancer and other life-threatening liver disease and past studies have shown that most injection drug users became infected with both viruses soon after they take up the habit. To address this danger, groups have implemented interventions such as needle exchange programs for at-risk populations.
Recently, researchers sought to determine what effect such interventions may have had, by determining the current prevalence and patterns of acquisition of those diseases among injection drug users. The investigation was led by Fan-Chen Tseng and Thomas R. O'Brien of the National Cancer Institute, and Brian R. Edlin of Weill Cornell Medical College's Center for the Study of Hepatitis C and the former Director of the Urban Health Study at the University of California, San Francisco.
They used data from the Urban Health Study, which recruited injection drug users in the San Francisco Bay area from 1986 to 2005. That study collected demographic information along with blood samples which were analyzed for seroprevalence of blood-borne infections. Tseng and colleagues focused on HCV and HBV antibody prevalence in users who participated between 1998 and 2000 and compared them to those of users who participated in 1987.
Of the 2,296 drug users included in the Urban Health Study between 1998 and 2000, 91 percent had antibody to HCV and 80 percent to HBV. However, those who had recently started injecting drugs had far lower rates. Only 47 percent of participants who had been injecting drugs for less than two years were infected with HCV, compared to 71 percent who had been using for 6-9 years. Comparable rates among the 1987 population were 76 percent and 91 percent.
For HBV, about 5 percent of the population had serologic evidence of vaccination against the virus. Among the others, 41 percent of those who had injected drugs for less than 2 years, and 57 percent of those who had been using for 6-9 years were infected. Comparable rates among the 1987 population were 45 percent and 80 percent.
Only 34 percent of the participants from 1998-2000 said they had shared syringes in the past 30 days, compared to about 59 percent who had done so in 1987.
Although the population examined in this study was not a random sample, and the authors had no way to pinpoint the reasons for the improvements over time, the reductions in infection rates the authors observed coincided with the institution of street-based outreach, HIV counseling and testing, and needle exchange programs.
The findings suggest that there is now a longer window of opportunity for interventions among this at-risk population. To reduce infection rates further, the authors suggest, it is also of paramount importance to reduce the number of people who start injection drug use and to make substance abuse treatment available to those who wish to stop.
The authors conclude, "It is encouraging that the frequency of HCV and HBV appears to have decreased markedly among new initiates to injection drug use in the San Francisco Bay area. If the reductions in the prevalence of these infections can be sustained, the risk of end stage liver disease and liver cancer should decrease in this population."
Reference: "Seroprevalence of Hepatitis C Virus and Hepatitis B Virus Among San Francisco Injection Drug Users, 1998-2000." Tseng, Fan-Chen; O'Brien, Thomas; Zhang, Mingdong; Kral, Alex; Ortiz-Conde, Betty; Lorvick, Jennifer; Busch, Michael P.; Edlin, Brian. Hepatology; September 2007; (DOI: 10.1002/hep.21765).
Note: This story has been adapted from a news release issued by John Wiley & Sons, Inc.
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Govt eyes funds for HCV therapy
http://www.yomiuri.co.jp/
The Yomiuri Shimbun
The government and ruling parties have decided to consider in the budget framework for the next fiscal year the inclusion of funds to offer public help for the notoriously expensive interferon therapy used to cure hepatitis C patients.
The number of people in the nation infected with the virus is estimated at 1.5 million. The government and ruling parties will also consider including funds to help cover treatment for hepatitis B and liver cancer, which often develops from hepatitis.
The meeting of the ruling parties' project team, which discussed measures to help hepatitis patients, opened Wednesday and hammered out plans for the compiling of a draft proposal including the scale of the budget, the range of assistance and specific measures for giving assistance.
According to Jiro Kawasaki, chairman of the team and former health, labor and welfare minister, it may only be a temporary budgetary measure, saying that "We're not seeing a growth in new hepatitis C patients."
According to the ministry, regular interferon treatment works for 60 to 70 percent of those infected with HCV, while particularly effective types of interferon treatment can provide a complete cure for 90 percent of patients.
The annual expense for the therapy is about 3 million yen per person, of which about 800,000 yen is borne by the patient. The high cost often makes patients give up on the therapy.
Kawasaki also commented on a recent series of HCV-related legal decisions in four district courts in Osaka, Fukuoka, Tokyo and Nagoya, in which the government suffered a partial defeat, saying that close attention would be paid to the coming ruling at the Sendai District Court on Friday and that this ruling would be taken into consideration when coming up with a solution to the HCV issue.
"As the ruling coalition, we must pay particular attention to the coming outcome of the Sendai District Court case, since the judgments in the previous [four] rulings were varied," Kawasaki said.
At the end of March, a group of plaintiffs in the HCV-related legal action handed then Deputy Chief Cabinet Secretary Hakubun Shimomura a statement urging Prime Minister Shinzo Abe to make an overall settlement. In June, the group conveyed to then Chief Cabinet Secretary Yasuhisa Shiozaki their demand that the government take urgent measures. Prime Minister Abe instructed the ministry to examine renewed measures and the developments in the legal cases.
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How a City Hospital Won Transplant Title
http://www.nysun.com/article/61882
BY ELIZABETH SOLOMONT - Special to the Sun
Many doctors declined to perform a kidney transplant on the 82-year-old man who contacted Dr. Sandip Kapur two years ago.
Dr. Kapur, a surgeon at NewYork-Presbyterian Hospital, agreed to operate on the man, whom he described as mentally sharp and otherwise physically healthy. Today, the patient is "living a great life," Dr. Kapur said.
Operations such as these have helped NewYork-Presbyterian become the largest transplant center nationwide. In 2006, surgeons there performed 800 transplants, including 562 at the main hospital and another 238 at a center for kidney disease that is affiliated with the hospital, the Rogosin Institute. Nationwide, UCLA Medical Center was the second busiest, with 697 surgeries. In New York, the next largest program was Mount Sinai Medical Center, with 373 surgeries.
In part, NewYork-Presbyterian's patient volume reflects the hospital's size, but transplant surgeons there also described a philosophy that includes the use of "expanded" criteria for transplantation, which ultimately means doctors there will operate on patients whom other doctors may reject as risky. In July, for example, doctors at NewYork-Presbyterian successfully transplanted five organs — a liver, small bowel, pancreas, colon, and stomach — into an 8-month-old baby boy born with congenital abnormalities.
By definition, "expanded" criteria refers to the data points surgeons consider when finding an appropriate organ for transplantation. Expanded donors may be older, and they may include those with prior hepatitis B or C infections, a history of hypertension or diabetes, or unusual anatomy. The term does not include patients who are medically unsuitable for surgery, such as those with active infections or cancer.
The approach, which has gained in popularity over the past five years, comes in part from a nationwide organ shortage. As of August 31, there were 97,125 individuals registered on a national waiting list for organ transplantation that is maintained by the United Network for Organ Sharing. In New York, there were 8,566 transplant candidates on the list, including 1,618 with a projected waiting time of five years or longer.
A new procedure three decades ago, transplantation has become one of the most highly regulated areas of medicine with a waiting list that is determined by a complex algorithm. A patient's place on the list is determined by such factors as blood and tissue type, medical urgency, time on the waiting list, and the transplant center's criteria for accepting organ offers.
While doctors at NewYork-Presbyterian said their emphasis on extended criteria comes from a drive to treat the sickest patients and make research advances, it is clear the missive is also a personal one for the hospital's president and CEO, Dr. Herbert Pardes, whose son has received three liver transplants.
"It's both a personal, medical, scientific, and business priority for the hospital," the chief of transplantation at NewYork-Presbyterian/Columbia University Medical Center, Dr. Jean Emond, said.
In recent years, NewYork-Presbyterian doctors have also worked to reduce immunosuppressive therapy for transplant patients, and they have developed a noninvasive test to predict organ rejection.
According to the Scientific Registry of Transplant Recipients, NewYork-Presbyterian showed statistically higher survival rates for kidney and lung transplant patients as of July 2007.
However, it is sometimes a precarious line to walk. Drawing on the example of treating an older patient, the chief of nephrology and transplantation at NewYork-Presbyterian's Weill Cornell Medical Center, Dr. Manikkam Suthanthiran, said: "These are the challenges when you're taking a scarce resource."
"You'd say, there are young people, why don't you put the kidney in them? This is where the challenge of utility versus social justice comes in," he said.
There are those who feel that using expanded criteria increases the chances of complications.
The director of transplantation at NYU Medical Center, Dr. Lewis Teperman, said using expanded criteria is a medically accepted practice. "The question is, how expanded are you willing to go? In certain individuals, these are going to work fine," he said. "On the other hand, if you put a 70-year-old liver into someone who had Hepatitis C, it would come back quicker in the older organ in the new recipient."
At Mount Sinai, the chief of the hospital's Transplantation Institute, Dr. Jonathan Bromberg, said expanded criteria donors are "not optimal."
"Their initial function is not as great as a standard criteria donor," he said. However, he painted a bleak picture of what a patient might otherwise face during an extended waiting period for a better organ. Sometimes, Dr. Bromberg said, "I'd like to get them a kidney, any kidney."
NewYork-Presbyterian doctors expressed a similar sentiment, saying the waiting list for organs has grown so large in recent years that the mortality rate is sometimes greater than the risk associated with receiving an organ that is less than perfect. Nationally, about 6,000 people a year die while waiting for transplants.
"We try to focus on the relative risk," the medical director of NewYork-Presbyterian/Columbia University Medical Center's Division for Liver Disease and Transplantation, Dr. Robert Brown, said.
"There's a big difference between perfect, acceptable, and unacceptable. And for any given individual, it's about a risk benefit decision," he said. Transplanting a 70-year-old liver into a 70-year-old recipient may be acceptable, although that same liver would not be acceptable for a reasonably stable baby, he said. "If the baby is critically ill in the ICU, that 70-year-old liver is starting to look a little bit better," he said.
In the New York metropolitan area, the number of organ donors increased by 47% between 2003 and 2006, according to the New York Organ Donor Network. However, those numbers are still too low to meet the demand, the group's president and CEO, Elaine Berg, said. "The limiting factor is organ donors," she said. In 2005, 319 individuals donated organs, up from 217 in 2003, she said.
But only about 1.5% to 2% of deaths are viable donors, she said. In New York, middle-age stroke patients are the most frequent donors.
"If there's a young person who dies, those people are generally healthier. They die healthier than older people, they are better organ donors," Ms. Berg said. However, she added, "Doctors like those at Columbia and New York-Presbyterian have really, really pushed the envelope because the need is becoming so great, and you can't wait for that young donor."
Some have proposed financial incentives to promote organ donations. "A regulated system that creates incentives for donors, whatever those incentives may be, would save lives, reduce the shortages that promote the black market, and level the playing field," the associate director of the American Council on Science and Health, Jeff Stier, wrote in the New York Post last month.
Ms. Berg rejected that proposal: "I think there are things we can try as a society before we turn the human body into a commodity."
Dr. Kapur said difficult cases don't necessarily translate into poor outcomes. In the case of the 82-year-old patient, he said: "Someone who is 70 or 75 doesn't need 15 years. They need maybe five or six years of quality life off dialysis, preventing some of their secondary conditions from progressing. That's an ideal situation to match extended donor organs."
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Public Communication - Health Canada Endorsed Important Safety Information on Ketek (telithromycin)
http://pharmalive.com
UPDATED INFORMATION on the antibiotic KETEK(R) (telithromycin)
LAVAL, QC, Sept. 5 /CNW Telbec/ - Sanofi-aventis Canada Inc., in consultation with Health Canada, would like to inform Canadian consumers of important new changes regarding the antibiotic KETEK(R) (telithromycin).
Do not take the antibiotic KETEK(R) to treat bronchitis, sinusitis, tonsillitis or pharyngitis (sore throat).
Upon review of the available safety information, including reported cases of severe liver problems, Health Canada has determined that the antibiotic KETEK(R) should no longer be prescribed or used to treat bronchitis, sinusitis, tonsillitis/pharyngitis (sore throat). If you are prescribed KETEK(R) for any of these conditions, ask your doctor about using other antibiotics instead.
KETEK(R) can still be used to treat community-acquired pneumonia ("CAP"). Before taking KETEK(R), discuss the possible side effects with your doctor, such as liver injury, fainting and difficulty seeing properly.
You should not take KETEK(R) if you have myasthenia gravis (a disease involving muscle weakness) or if you have had jaundice, hepatitis, or other signs of liver injury while or after taking KETEK(R) or macrolide antibiotics (such as clarithromycin (Biaxin(R)), azithromycin (Zithromax(TM)) or erythromycin).
Complete product information will be available in the official Canadian Product Monograph for KETEK(R) (see Part III: CONSUMER INFORMATION). The revised Product Monograph will be posted at www.sanofi-aventis.ca as soon as it is available.
Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious liver-related problems, exacerbations of myasthenia gravis, visual disturbances, fainting or other serious or unexpected adverse reactions in patients receiving KETEK(R) should be reported to sanofi-aventis Canada Inc. or Health Canada at the following
addresses:
Any suspected adverse reaction can be reported to:
sanofi-aventis Canada Inc.:
Toll-free telephone: 1-800-265-7927
Internet: www.sanofi-aventis.ca
Regular mail:
sanofi-aventis Canada Inc.
2150 St. Elzear Blvd. West
Laval, Quebec
H7L 4A8
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: (613) 957-0337 or Fax: (613) 957-0335
To report an Adverse Reaction, consumers and health professionals may
call toll free:
Tel: 866 234-2345
Fax: 866 678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/form/ar-ei_form_e.html
http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/guide/ar-ei_guide-ldir_e.html
Sincerely,
original signed by
Franca Mancino, M. Sc.
Senior Director, Regulatory Affairs & Pharmacovigilance
sanofi-aventis Canada Inc.
For further information: Health Canada: Marketed Health Products
Directorate (MHPD), MHPD_DPSC@hc-sc.gc.ca , (613) 954-6522, Fax: (613) 952-7738/
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InterMune Announces Approval of Clinical Trial Authorization for Phase 1b Trial of ITMN-191
http://www.therapeuticsdaily.com
BRISBANE, Calif., Sept. 4 /PRNewswire-FirstCall/ -- InterMune, Inc. today announced that the amended Clinical Trial Authorization (CTA) related to the Phase 1b clinical trial of ITMN-191 (Roche-R7227) has been approved by the appropriate European regulatory authorities. InterMune also has received approval from the Ethics Committee of the institutions that will conduct the Phase 1b study. ITMN-191 is an orally available hepatitis C virus (HCV) protease inhibitor in development by InterMune and its partner, Roche.
InterMune expects that the Phase 1b multiple ascending dose (MAD) study will begin this month and expects to announce initial top-line viral kinetic and safety results from the first three dose cohorts of the MAD study in the first quarter of 2008.
Dan Welch, President and Chief Executive Officer of InterMune, said, "InterMune and Roche are pleased to announce that we have successfully secured the required regulatory approvals that enable us to initiate our very important Phase 1b multiple ascending dose study. By amending the Phase 1b protocol, we believe we have enhanced our ability to deliver the most robust Phase 1b results possible which we expect will place us in a stronger position to begin our Phase 2 trials."
In early May, InterMune announced that it would amend the CTA to take into consideration new information on competitive protease inhibitors, in-vitro and preclinical data on ITMN-191 and pharmacokinetic observations from a Phase 1a study that was completed in May of 2007. In that study, a higher than anticipated exposure of ITMN-191 in plasma was observed in subjects dosed with food, suggesting that ITMN-191 may be administered in subsequent clinical studies at lower doses than were previously estimated.
The Phase 1b study is designed to assess the effect on viral kinetics, viral resistance, pharmacokinetics, safety and tolerability of multiple ascending doses of ITMN-191 given as a monotherapy. InterMune plans to administer ITMN-191 for a period of 14 days to three ascending dose cohorts of treatment-naive chronic hepatitis C patients infected with HCV genotype 1. Twice per day (BID) and three-times per day (TID) dose regimens will be studied. In addition, a single cohort of non-responder patients will be studied. If results of the first three dose cohorts indicate that more information would be desirable to fully inform the Phase 2 program, the Phase 1b study will be expanded to additional cohorts.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 within the Roche research and development programs) in Phase 1a, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com/.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated product development timelines. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the SEC on March 30, 2007 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the long, expensive and uncertain clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues or delays in anticipated timing of the regulatory approval process; (ii) risks related to failure to achieve the clinical trial results required to commercialize our product candidates; and (iii) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at http://www.intermune.com/.
InterMune, Inc.
CONTACT: Jim Goff of InterMune, Inc., +1-415-466-2228,
jgoff@intermune.com
Web site: http://www.intermune.com/
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Research on hepatitis genetics detailed by scientists at Tokyo Women's Medical University
http://www.therapeuticsdaily.com
Hepatitis Weekly - Sep. 03, 2007
New investigation results, "Possible involvement of cytokine gene polymorphisms in fulminant hepatitis," are detailed in a study published in Journal of Gastroenterology and Hepatology. "Host genetic factors have been reported as influencing the progress to fulminant hepatitis (FH). Our previous data showed the serum level of tumor necrosis factor (TNF)-alpha influenced by gene polymorphisms to be markedly increased," scientists writing in the Journal of Gastroenterology and Hepatology report.
"It was investigated whether polymorphisms in the IL-10 gene, in addition to TNF-alpha and -beta gene polymorphisms, might contribute to the pathogenesis of FH. We analyzed 42 patients with FH, 78 patients with acute hepatitis (AH), and 149 healthy subjects (control). IL-10 polymorphism sites at promoter regions -1028, -819, -592; TNF-alpha polymorphism sites at promoter regions -1031, -863, -857, -308, -238; and TNF-beta first intron Nco1 sites were studied. IL-10 gene polymorphisms were classified into three groups: low IL-10-producing haplotypes (ATA/ATA), intermediate haplotypes (ATA or CCA/CCA), and high haplotypes (ATA/ATG or CCG). The allelic frequency of B2 in the TNF-beta gene was significantly higher in FH patients compared with the control group. The three groups showed no differences in polymorphisms of positions -1031, -863, -857, -308 and -238 in the TNF-alpha gene. The frequency of low IL-10-producing haplotypes tended to be higher in FH patients compared with control and that of high IL-10-producing haplotype tended to be lower in FH patients compared with control," wrote M. Takakura and colleagues, Tokyo Women's Medical University.
The researchers concluded: "The carrier rate with both the IL-10 haplotype and the TNF-beta gene B2/B2 was significantly higher than control. Variations of cytokine polymorphisms including IL-10 and TNF-beta genes may be attributable to the pathogenesis of FH."
Takakura and colleagues published their study in the Journal of Gastroenterology and Hepatology (Possible involvement of cytokine gene polymorphisms in fulminant hepatitis. Journal of Gastroenterology and Hepatology, 2007;22(8):1271-7).
Additional information can be obtained by contacting M. Takakura, Tokyo Women's Medical University, Dept. of Internal Medicine and Gastroenterology, School of Medicine, Tokyo, Japan.
The publisher of the Journal of Gastroenterology and Hepatology can be contacted at: Blackwell Publishing Asia, 54 University St., PO Box 378, Carlton, Victoria 3053, Australia.
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September 6th, 2007
Hep C hope hovers on the horizon
http://www.biopharma-reporter.com
By Kirsty Barnes
06/09/2007 - Hope may be on the horizon in the quest for a preventative hepatitis C virus (HCV) vaccine after scientists said they have been able to identify and characterise the antibody responses to the virus.
A research team from Nottingham University presented new data this week claiming they have pinpointed monoclonal antibodies (mAbs) that can successfully prevent HCV infection - of numerous different strains - in vitro.
In laboratory models the scientists were able to use these mAbs to neutralise a receptor molecule on the surface of healthy cells in the body, that certain glycoprotieins (E1 and E2) on the surface of the HCV attach to, in order to infiltrate and infect the cells.
Neutralising this receptor molecule effectively renders the HCV powerless to enter and infect the healthy cells, the researchers found.
The findings were presented on Tuesday in a paper titled: 'Human antibodies to hepatitis C virus - potential for vaccine design' at the annual Meeting of the Society for General Microbiology, held at the University of Edinburgh.
Based on these findings, the researchers are now working on developing vaccine candidates against the HCV and said such a vaccine could potentially be available within ten years.
"If the antibodies we have discovered can be reproduced by vaccination, control of the disease might be possible…The clinical potential of this work cannot be overstated", said Dr Alexander Tarr from Nottingham University's Virus Research Group.
"Identifying regions of the virus that are able to induce broadly reactive neutralising antibodies is a significant milestone in the development of a HCV vaccine…and could also help us design vaccines for other chronic viral diseases such as HIV."
HCV is a major cause of chronic liver disease and 170m people worldwide carry the disease. In 2006 worldwide sales of HCV therapies totalled €3.5bn. However, although these drugs can potentially cure HCV, half of patients remain unresponsive to current treatments.
No preventative drugs have yet been developed, however, vaccines are now the focus of a lot of current research into improving the treatment and prevention of this potentially deadly disease.
"Historically, successful vaccines against viruses have required the production of antibodies, and this is likely to be the case for hepatitis C virus", said Dr Tarr.
The scientists from Nottingham are not alone in their quest to develop HCV vaccines. Novartis in particular is active in this cutting-edge area of drug development.
A biologic the vaccines giant is co-developing with Human Genome Sciences (HGS) to treat chronic HCV cleared Phase II trials in April.
The drug, Albuferon (albinterferon alfa-2b), is a novel long-acting form of interferon alpha - an approved treatment of HCV - and is created by genetically fusing it to human albumin, which has the effect of decreasing the clearance and prolonging the half-life of the therapeutic protein.
Meanwhile, Novartis is also in co-development with Intercell for a peptide-based vaccine against chronic HCV, which has recently shown promise in interim Phase II trial data.
The vaccine (IC41) comprises of eight T-cell antigens, combined with its first-generation poly-arginine adjuvant (IC30). It is designed to stimulate T-cell responses against HCV protein structures and reduce viral load.
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Pharmasset and Roche to Present R7128 Data at the 14th International Symposium on Hepatitis C Virus and Related Viruses
http://biz.yahoo.com
PRINCETON, N.J., Sept. 6 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS - News) and Roche (OTC: RHHBY - News) announced today that four scientific presentations related to R7128 for the treatment of chronic hepatitis C virus (HCV) will be made at the 14th International Symposium on Hepatitis C Virus and Related Viruses being held from September 9-13, 2007 in Glasgow, Scotland. R7128, a prodrug of PSI-6130, is an oral cytidine nucleoside analog polymerase inhibitor of HCV that is being developed through Pharmasset's collaboration with Roche. In addition, Pharmasset will present data on proprietary phosphoramidate HCV RNA inhibitors. The conference abstract information is listed below, and the poster presentations will be available in the "Events & Presentations" section of Pharmasset's website at http://www.pharmasset.com on September 10, 2007.
"The presentations at the HCV Symposium represent our growing knowledge about R7128's preclinical properties, clinical safety and pharmacokinetics," stated Dr. Michael Otto, Pharmasset's Executive Vice President, Pharmaceutical Research. "In addition, Pharmasset's internal HCV discovery efforts have identified additional proprietary compounds that may have complementary or improved properties. We will carefully evaluate these molecules for potential advancement toward future development."
Poster presentations at the 14th International Symposium on Hepatitis C Virus and Related Viruses will include:
- Abstract P-268: Pharmacokinetics, Safety, and Tolerability of R7128, a Novel Nucleoside Polymerase Inhibitor for HCV Following Single, Ascending Oral Doses in Healthy Volunteers. Otto MJ, Robson R, Rodriguez CA, Beard A, Symonds WT, Hill G and Berrey MM (Pharmasset, Christchurch Clinical Studies Trust and Roche Palo Alto).
- Abstract P-262: The Mechanism of Action of Beta-D-2'-Deoxy-2'-fluoro-2'-C-methylcytidine Involves a Second Metabolic Pathway Leading to Beta-D-2'-Deoxy-2'-fluoro-2'-C-methyluridine 5'-Triphosphate, a Potent Inhibitor of the HCV RNA-Dependent RNA Polymerase. Murakami E, Niu C, Bao H, Micolochick Steuer HM, Otto MJ and Furman PA (Pharmasset).
- Abstract P-265: The Nucleoside Inhibitors R1479, PSI-6130, and NM107 have a Higher Genetic Barrier to Resistance than the Non-nucleoside Inhibitor HCV-796 and the Protease Inhibitor VX-950. McCown M, Rajyaguru S, Symons J, Cammack N and Najera I (Roche Palo Alto).
- Abstract P-263: In Vitro Selection and Characterization of HCV Replicons Resistant to PSI-6130. Ali S, Leveque V, LePogam S, Ma H, Philipp F, Najera I, Klumpp K, Symons J, Cammack N and Jiang WR (Roche Palo Alto).
- Abstract P-259: Beta-D-2'-Deoxy-2'-fluoro-2'-C-methyluridine Phosphoramidates: Potent and Selective Inhibitors of HCV RNA Replication. Sofia MJ, Wang P, Du J, Micolochick Steuer HM, Niu C, Furman PA and Otto MJ (Pharmasset).
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is expected to enter Phase 3 clinical trials for registration in the Americas and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals under the brand name Levovir. R7128, an oral treatment for chronic HCV infection, is in a Phase 1 clinical trial through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.
About R7128
R7128 is being developed for the treatment of chronic hepatitis C. R7128 is a prodrug of PSI-6130, which demonstrated potency in preclinical studies. PSI-6130 is a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase, an enzyme that is necessary for hepatitis C viral replication. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.
R7128 Phase 1 Study Overview
The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study to investigate the pharmacokinetics, pharmacodynamics, safety, tolerability and food effect of R7128 in healthy volunteers and in patients chronically infected with HCV genotype 1. This Phase 1 study is comprised of two parts:
- Part 1 is a single ascending dose study of R7128 conducted in 46 healthy volunteers. The primary objective of Part 1 is to assess the safety, tolerability and pharmacokinetics of R7128 following single ascending doses under fasting conditions. The secondary objective of Part 1 is to explore the effect of food on the pharmacokinetics of R7128. Preliminary data from the single ascending dose portion of the study indicate:
- All doses of R7128 studied were generally safe and well-tolerated.
- All patients completed the study, and none experienced gastrointestinal adverse events or serious adverse events during the study.
- No hematological or laboratory abnormalities of clinical significance were noted.
- Part 2 is a multiple ascending dose study of R7128 conducted in 40 patients chronically infected with HCV genotype 1 who have previously failed interferon therapy. The primary objective of Part 2 is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days. The secondary objective is to assess antiviral efficacy by measuring the change in HCV RNA.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and liver transplants. The WHO estimates that nearly 180 million people worldwide, or approximately 3% of the world's population, are infected with hepatitis C virus (HCV). The CDC has reported that almost four million people in the United States have been infected with HCV, of whom 2.7 million are chronically infected.
Contact
Alan Roemer, Vice President
Investor Relations & Corporate Communications
alan.roemer@pharmasset.com
Office: (609) 613-4125
Forward-Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are "forward-looking statements" that involve risks and uncertainties, including without limitation the risk that there will be a delay in the presentation of R7128 data at upcoming conferences, the risk that the R7128 data to be presented at upcoming conferences is not accurate or representative, the risk that the preliminary data from the R7128 Phase 1 Study is not accurate or representative, the risk that our collaboration with Roche will not continue or will not be successful, the risk that the on-going or anticipated clinical trials for any one or more of our product candidates will not be successful, the risk that any one or more of our product candidates will not be successfully developed and commercialized, and the risk that our proprietary compounds will not be successfully developed into product candidates or commercialized. For a discussion of these risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 filed with the Securities and Exchange Commission entitled "Risk Factors" and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.
Source: Pharmasset, Inc.
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September 7th, 2007
State cleared in hepatitis C suit
http://www.asahi.com
THE ASAHI SHIMBUN
SENDAI--In a ruling that surprised both plaintiffs and health officials, the district court here said Friday the state was not to blame for a spate of hepatitis C infections from tainted blood products.
The Sendai District Court's decision was the first ruling that did not hold the state responsible in any way for the widespread hepatitis C infections from medical treatment with such hemostatic agents as fibrinogen.
The court rejected most of the plaintiffs' claims that the negligence of three drug makers and the state had caused their sufferings.
The court partially acknowledged the drug makers' responsibility, awarding only one of the six plaintiffs 11 million yen in compensation.
Citing the effectiveness of fibrinogen, Presiding Judge Yoshiko Hatanaka said the fact the state did not order its manufacturer to warn against risks was "within (a health minister's) discretion."
In the preceding four rulings, the district courts in Osaka, Fukuoka, Tokyo and Nagoya found the government responsible to varying degrees.
Plaintiffs and their supporters called Friday's ruling "unfair."
"I can't believe what happened because we were confident we would win," said Michiko Yamaguchi, who represents a group of 171 patients who filed the suits. "It's so regrettable that our victories in the four earlier rulings and surges of public opinions did not reach the judges."
Yamaguchi, 51, a plaintiff in the Fukuoka suit, caught the virus from fibrinogen when she gave birth in 1987.
The Sendai court's ruling surprised health ministry officials as well.
Health minister Yoichi Masuzoe only said he will comment after studying the ruling.
But he said earlier that the government will try to swiftly work out relief measures for all patients regardless of the litigation outcome.
A ruling coalition panel recently decided on a plan to subsidize expensive interferon treatment.
At the Sendai court, four women and two men, in their 40s to 70s, had demanded a total of 300 million yen in damages from the state and three makers: Mitsubishi Pharma Corp.; its subsidiary Benesis Corp.; and Nihon Pharmaceutical Co.
Mitsubishi Pharma is the successor to now-defunct Green Cross Corp.'s fibrinogen and christmassin business.
Nihon Pharmaceutical produced and sold PPSB-Nichiyaku.
The plaintiffs had argued that the risks of tainted blood products should have been foreseen from research results as far back as 1964, when production of fibrinogen was approved.
The ruling, however, said Green Cross should have been aware of fibrinogen's risks in April 1987, and that the company was responsible for failing to warn against the risks of side effects only after that time.
The negligence continued until February 1988, when it sent out warning messages, the court said.
The court thus ordered Mitsubishi Pharma and Benesis to compensate one plaintiff who was apparently infected from fibrinogen given during that period.
But since the risks of infections "were not positively recognized" during that time, the government cannot be held responsible, it said.(IHT/Asahi: September 8,2007).
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Innogenetics abandons E1 hepatitis C vaccine development
http://www.sharewatch.com
BRUSSELS (Thomson Financial) - Belgian drug company Innogenetics said it has abandoned the development of its E1-based viral hepatitis C vaccine as clinical trials failed to show the drug slows down liver tissue damage.
The company said in a statement it has decided to discontinue further investment in the vaccine in favour of other drugs in the pipeline.
Chief executive Frank Morich said in a statement: "Despite this setback, we intend to pursue the development of our next generation of immune therapeutics through our soon-to-be spun-off Therapeutics entity." phil.mccomish@thomson.com
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September 20, UAB Liver Center To Host Viral Hepatitis Forum
http://main.uab.edu/
Media Contact:
Troy Goodman
(205) 934-8938
E-mail: tdgoodman@uab.edu
BIRMINGHAM, Ala. – UAB Liver Center will host a public forum, ‘ABC’s of Viral Hepatitis,’ in Hoover this month.
The free two-hour forum will give adults and children interested in or diagnosed with viral hepatitis a chance to listen to experts and ask questions about the disease.
“Liver disease continues to be a challenging problem for patients and their loved ones,” said UAB Liver Center Director Joseph Bloomer, M.D., a professor of medicine and genetics. “One of our missions is to provide an education program for newly diagnosed and chronically affected patients and their families, and provide efforts aimed at preventing the spread of viral hepatitis among children and teens.”
The forum will be Thursday Sept. 20 from 2-4 p.m. at The Wynfrey Hotel, 1000 Riverchase Galleria, Hoover. For more information call the Liver Center at (205) 975-5676, e-mail at LiverCenter@uab.edu or visit www.dom.uab.edu/gastro/livercenter .
The purpose of the Thursday forum is to provide a comprehensive picture of viral hepatitis, including hepatitis A, B and C. Discussion topics will focus on available hepatitis therapies, clinical research and how to live with the disease.
The forum will also mark the kick-off of the Liver Center’s new patient and caregiver support network, the UAB Liver Disease Support Group.
The Liver Disease Support Group is open to anyone, and is scheduled to meet monthly at The Kirklin Clinic. The support group’s first regular meeting is set for Oct. 9, 6 p.m. in The Kirklin Clinic’s first-floor learning center.
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