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Week Ending: March 24th , 2007
Alan Franciscus
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March 17th , 2007
Doctor Worked on at Hospitals with Serious Liver Disease
http://www.yorkshiretoday.co.uk
By Alexandra Wood
A DOCTOR employed at two busy Yorkshire hospital casualty departments has admitted putting patients at risk by continuing to work despite having hepatitis B.
Congolese Dr Daniel Mutunda, 43, who worked at both Hull Royal Infirmary and Barnsley Hospital accident and emergency departments, pleaded guilty to three charges of deception at Hull Crown Court yesterday.
Police yesterday said the case, which involved a string of health service trusts up and down the country and led to more than 80,000 patient records being checked, revealed "a massive lapse" in the system for checking credentials.
Even if the doctor, who is currently suspended by the General Medical Council (GMC), is struck off, police say he can still go and work at hospitals abroad.
Married Dr Mutunda came to Britain in 1999 and applied for a clinical attachment at a hospital in Barking, Essex, in 2001.
He tested positive for hepatitis B – a potentially fatal liver infection – when he gave a blood sample and was offered another job in clinical psychiatry at the same hospital, but refused.
The virus is transmitted through contact with blood and body fluids and those found carrying the virus are not allowed to work in "exposure-prone" areas and are restricted in what they can undertake.
Despite this the regular churchgoer, of Barking, Essex, who gave 10 per cent of his income to the church, then applied successfully to work at Barnsley Hospital – using a friend's blood sample.
He later worked at hospitals including York Hospital, the Royal Devon and Exeter Hospital, Whittington Hospital in London, West Middlesex University Hospital in Isleworth and Hillingdon Hospital in Uxbridge, at times earning as much as £100 an hour.
He was suspended by the GMC in 2004 after being recognised by a member of staff when he returned to work at the Barking hospital, but went to work as a locum at Hull Royal Infirmary a week later. His activities were finally uncovered when an agency checked with the GMC and found he had been suspended.
NHS trusts where he had worked were alerted and launched their own investigations.
Det Sgt Dave Wescott said Dr Mutunda was "fairly remorseful", adding: "He has exposed numerous patients to unnecessary risks.
"I haven't been informed but I believe we have been lucky and no one has been infected because of this doctor's actions.
"The worrying thing is he can now go abroad and practise even if he is struck off."
Det Sgt Wescott said Dr Mutunda, who despite his earning potential was heavily in debt, had used the same blood test result from 2001 to apply for NHS jobs, which had not been checked.
"If he hadn't been recognised he could have still been practising for all I know," he said.
"He was providing for his family; basically he trained all his life as a doctor and he was suddenly faced with something that ruined his life. He made a conscious decision to carry on."
The doctor admitted three charges of obtaining a financial advantage by deception, by falsely claiming to be medically fit to practice.
The first of the charges related to a period between March 2001 and August 2001 when he worked at Barnsley Hospital, the second a period of less than a month when he worked at Hull Royal Infirmary between May 2004 and June 2004, and finally between November 2004 and February 2005, again at the infirmary. He will be sentenced on April 16.
The GMC said: "Doctors who have been convicted of an offence may be referred to a public hearing in which a panel will make decision about their fitness to practise."
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March 18th, 2007
City at Center of 'Hep C' Epidemic
http://www.nypost.com
By SUSAN EDELMAN
March 18, 2007 -- Hepatitis C has "exploded" into a statewide epidemic, with a doubling of reported cases in the last five years seen as only "the tip of the iceberg," officials told The Post.
"New York City is the epicenter," said Dr. Guthrie Birkhead of the state Health Department.
The agency is sponsoring a conference in Manhattan this week to unveil battle plans to stop "the silent epidemic" - so called because many people infected with the blood-borne virus show no symptoms for 20 or more years.
By then, the chronic infection has developed into deadly liver disease, usually requiring a transplant.
"A lot of people don't know they have it, so they don't get tested," Birkhead said. "The cases we do get reported are probably the tip of the iceberg of what's out there."
According to the most recent statistics, New York City tallied 14,297 new cases of hepatitis C in 2005.
The state is still gathering data from prior years, but officials are bracing for a steep hike, based on other findings.
For instance, the number of new cases in the rest of the state - 7,119 last year - has doubled from the 3,451 in 2001.
"We expect a similar explosion in New York City," said state Health Department spokesman Marc Carey.
Hepatitis C infects nearly three times as many people as AIDS. Like HIV, it is commonly spread via intravenous needles by those who inject heroin, steroids and other illegal drugs.
"The sharing of equipment and needles between people is usually how this virus gets transmitted," Birkhead said.
Having sex with multiple partners also puts people at risk.
Health officials plan to fight the virus' spread by calling on patients who may be at risk and their doctors to ask for tests.
They also want to spread the word that a cure has emerged in the last five years. Interferon injections combined with oral medication can wipe out the virus in more than half of patients, if caught in time, Birkhead said.
susan.edelman@nypost.com
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Scientists Link Hepatitis C Virus, LDL Production
http://www.dallasnews.com
Sue Goetinck Ambrose
The hepatitis C virus is produced in the same part of liver cells as the compound that turns into LDL, the "bad" cholesterol, Dallas scientists have reported. That means that drugs that stop the release of the compound that turns into LDL could be useful to treat hepatitis C infections.
In a study released online this week in the Proceedings of the National Academy of Sciences, researchers from UT Southwestern Medical Center in Dallas describe the experiments that showed how hepatitis C virus particles are produced in liver cells. The researchers, led by cell biologist Jin Ye, isolated tiny vesicles from liver cells that contained virus particles in the process of assembling. In those same vesicles, the scientists found substances needed to form VLDL, which turns into LDL when it reaches the bloodstream.
Interestingly, a drug that blocks release of VLDL from liver cells also blocked release of virus particles. The drug, which has been tested in humans as a cholesterol-lowering medication, was never approved because it had bad side effects when given long term, Dr. Ye said.
But, he said, it's possible that giving the drug short term may be able to thwart hepatitis C infections. Dr. Ye said he and colleagues are in the planning stages of human testing. Other researchers who participated in the study were UT Southwestern's Hua Huang, Fang Sun, David Owen, Weiping Li, Yan Chen and Michael Gale.
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March 19th, 2007
Dumaguing: Aminoleban Nurtures and Heals Sick Livers
http://sunstar.com.ph/
By Dr. Vic Dumaguing
THE liver is the single biggest organ in the body. The liver is a virtual factory, with so many varied functions that contribute to the overall normal functioning of the whole body. Only some of its functions are related to digestive in nature.
The nutrients of food are absorbed into the wall of the intestine, which is supplied with many tiny blood vessels, which flow into veins that join larger veins and eventually enter the liver as the portal vein. This vein splits into tiny vessels inside the livers where the incoming blood van be processed in two ways; bacteria and other foreign particles are removed and many nutrients absorbed from the intestines are further broken down so that they can be used by the body. The liver performs the necessary processes at high speed and passes into blood laden with nutrients into the general circulation. For such an enormous task, the liver is adequately supplied with blood; at any given time, the liver has 1.5 liters of the total five liters of blood that each adult has; one liter is in the portal vein while 500 ml is in the hepatic arteries.
Alcoholic liver disease is damage to the liver that results from excessive drinking of alcohol. Women are more vulnerable to liver damage than men. However, the amount of alcohol that causes liver damage varies from one person to the other. Alcohol may cause three types of liver damage: fat accumulation or fatty liver, alcoholic hepatitis and liver cirrhosis.
Cirrhosis is the destruction of normal liver tissue that leaves nonfunctioning scar tissue surrounding areas of functioning liver tissue. Alcoholic abuse is a common cause. Among people aged 45 to 65 years old, cirrhosis is the third most common cause of death, after heart disease and cancer. People with cirrhosis are weak, with poor appetite, feel sick and lose weight. If bile flow is always obstructed, the person has jaundice (yellowish discoloration of eyes and skin), itching and small yellow skin nodules especially around the eyes. Malnutrition commonly results from a poor appetite and the impaired absorption of fats and fat-soluble vitamins.
Malnutrition is associated with increased morbidity (illness) and mortality (death) rates in patients with cirrhosis. These patients have a higher rate of hepatic encephalopathy (coma) infection and variceal bleeding from the esophagus. Intervention in the early stages of malnutrition can improve outcomes. The goal of nutritional therapy is to improve the protein-calorie malnutrition and to correct specific nutrient deficiencies.
How reassuring to know that Aminoleban is here. At the recently concluded annual convention of the Philippine Society of Gastroenterology and induction of the members of the Hepatology Society of the Philippines on March 12-14 at the EDSA Shangrila, different modalities of alleviating the malnourished state of the liver patient were discussed and naturally, the attention gravitated towards Aminoleban, composed of branched-chain amino acid supplementation. It has been proposed that depletion of the branched-chain amino acids might promote the development of hepatic encephalopathy by enhancing or increasing the passage of aromatic amino acids like tryptophan, tyrosine and phenylaline across the blood brain barrier, leading to the formation of false and unwanted neurotransmitters. A 2003 review of 11 randomized trials concluded that indeed, the use of branched-chain amino acids (BCAAs) improved hepatic encephalopathy especially when administered.
A recent multi-centre, randomized study demonstrated that oral supplementation with BCAAs for two years, improved survival, serum albumin concentration and the quality of life in patients with cirrhosis.
Aminoleban comes in two forms, the Parenteral solution for injection, indicated for the treatment of hepatic encephalopathy in patients with acute and chronic liver disease. It is particularly useful and beneficial in patients with hypercatabolic states like surgery, trauma, burns with evidence of negative nitrogen balance.
Aminoleban Oral is an enteral formula containing amino acids (branched-chain), carbohydrates, fats, vitamins, minerals as a dietary supplement especially for patients with liver impairment. The usual dose is 50 grams (one sachet) three times a day. The 50-gram sachet of Aminoleban can be reconstituted with 180 ml of lukewarm water. The 150-gram per day provides 40.5 grams of protein and a total of 630 calories. Occasional nausea and diarrhea may occur.
Thus, if you have liver disease, strictly follow you doctor's advice especially with regard to alcoholic intake. Heed their advice of small frequent five small feedings per day and cap it with a late night snack. And if the need arises, there is always Aminoleban.
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Date Set for NHS Inquiry
http://www.thisislancashire.co.uk/
By Jane Lavender
A CAMPAIGNER who has battled for almost 20 years to discover why haemophilia sufferers became infected with HIV or hepatitis C is delighted a date for a formal inquiry into the tragedy has been set.
David Fielding was given tainted blood products in transfusions by the NHS which gave him hepatitis C and destroyed his liver.
His brother, Brian, also a haemophiliac, contracted AIDS by the same process and died in 1990.
Last month it was announced that Lord Archer of Sandwell would chair the independent inquiry, and it has now been confirmed the inquiry will start on March 27.
Mr Fielding, aged 51, of Darley Avenue, Farnworth, now hopes he will be called to give evidence to the inquiry, which he says should provide much needed answers.
The father-of-three said: "This will at last provide some closure to people. It will heal some of the hurt. It will never fully go away, but it will enable us to get on with what's left of the rest of our lives."
After being treated with contaminated blood during the 1970s and 1980s, 4,670 people were diagnosed with hepatitis C and 1,243 were told they had HIV. Just 2,552 patients with hepatitis C and 361 with HIV are still alive today.
In 1993 Mr Fielding was told he had hepatitis C and by 1995 his liver was riddled with cirrhosis. Just hours from death he was given a life-saving transplant, which has not only cured him of his liver disease, but also his haemophilia.
The inquiry will also be carried out by Lord Tunberg, past president of the Royal College of Physicians, Dr Judith Willets, chief executive officer of the British Society for Immunology and Dr Norman Jones a consultant physician at a London hospital.
It will investigate the circumstances surrounding the tragedy and its consequences.
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March 20th, 2007
Liver Foundation Highlights Cancer, Hepatitis Link
http://www.taipeitimes.com
By Angelica Oung
STAFF REPORTER
A large number of Taiwanese hepatitis B and C carriers are oblivious to their condition, the Liver Disease Prevention and Treatment Research Foundation said yesterday, and this ignorance could carry a heavy price, as the likelihood of a hepatitis sufferer developing liver cancer rises a hundredfold over the years.
The foundation has been testing people for hepatitis B and C since 1996.
Yesterday, it released the aggregate data gathered during the course of its work to raise awareness of the link between hepatitis and cancer, giving a glimpse of the prevalence of what it has dubbed "public-health enemy No. 1."
Hepatitis B and C are viruses that attack the liver, lead to cirrhosis and ultimately liver cancer in some. Until it was surpassed by lung cancer, liver cancer was the nation's deadliest cancer.
According to the foundation's screening of 160,000 Taiwanese above the age of 18 between 1996 and 2005, 17.3 percent of the population is afflicted with hepatitis B, making the disease more than 40 times more prevalent in Taiwan than the in US. Hepatitis C, which is less common in Taiwan and more common in the US, was found in 4.4 percent of the population, more than three times the US rate.
Sheu Jin-chuan (許金川), executive director of the foundation, estimated that more than 90 percent of Taiwanese adults become infected with hepatitis B at some point in their lives, although in many the virus in the body falls below detectable levels.
"With interferon therapy we can depress the level of virus present in patients to minimize the risk of cirrhosis and ultimately hepato-cellular cancer," Sheu said. "Does that mean recovery? No. The virus could still cause mischief in the liver years after it seemed to have disappeared."
"Hepatitis sufferers need to be made aware that they are at an increased risk of liver cancer because there are no nerves inside the liver, meaning that by the time a doctor detects the cancer, it's already way too late," he said.
Since 1975, hepatitis B vaccines have been mandatory for all babies born in Taiwan.
"There is a failure rate for the vaccine, which accounts for why 1.4 percent of children in Taiwan are hepatitis B carriers despite being vaccinated," Sheu said.
Sheu recommended that foreign residents in Taiwan who have not been vaccinated against hepatitis B do so if tests reveal they have not yet been infected.
"Even going to the hairdresser or the dentist could present a risk," Sheu said.
The main means of transmission for the virus include mother-to-child transmission, unclean needles and unprotected sex.
Sun Juei-low (宋瑞樓), professor emeritus at National Taiwan University, has fought hepatitis for 55 years. He attributes Taiwan's widespread hepatitis rates to flawed medical practices such as inadequate sterilization of acupuncture needles.
"I would like to retire, but the virus will not let me," he said.
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Alberta Hospital Closed after Superbug, Sterilization Problems
http://www.cbc.ca/
CBC News
Health officials are reviewing four years of patient records at a rural Alberta hospital after an investigation into a superbug outbreak revealed that hospital equipment wasn't properly sterilized.
Dr. Gerhard Benadé, the region's medical health officer, issued a public health order Friday requiring St. Joseph's General Hospital in Vegreville to halt all admissions and close its sterilization room. The order was not made public until Tuesday.
Benadé discovered the sterilization problem while investigating an outbreak among patients of methicillin resistant staphylococcus aureus, or MRSA.
Seven patients in the 25-bed hospital east of Edmonton contracted the antibiotic-resistant bacterial infection over a one-month period beginning in mid-January.
"These are minor infections, usually skin infections, if any symptoms at all," said Dr. Karen Grimsrud, deputy provincial health officer.
Grimsrud said the bug is generally spread by health-care workers not washing their hands between patients.
'Entirely about patient safety'
While investigating the outbreak, Benadé uncovered the unrelated problem of improper sterilization of medical equipment at the hospital.
Benadé said it was the first time he had been in the sterilization room since he started his job six years ago, and he made the decision to shut the room down as soon as he saw the problem.
He said the risk to patients is low.
"We want to be transparent with this process. It is entirely about patient safety. We will err on the side of caution. We will identify every single individual that might potentially be at risk."
Health officials are now checking records of patients back to April 2003, including those who had surgeries or emergency room procedures. They are sending letters to those exposed to equipment that was inadequately sterilized and advising them to get tested for HIV, as well as hepatitis B and C.
Alberta Health Minister Dave Hancock said although the risk to patients is low, it is prudent to review four years of medical records just in case.
"What we do know is that patients who have had surgical procedures or treatment in the emergency room at St. Joseph's may be at very low risk of exposure to blood-borne pathogens," he said.
Contaminated with tissue, blood
The emergency room alone sees 14,000 people every year.
Grimsrud confirmed that for one biopsy procedure alone — cystoscopy — 80 patients were being contacted. Scopes used during surgery need to be thoroughly sterilized, but that wasn't happening at St. Joseph's, she said.
"There's tissue and blood left from the previous patient in that scope if it was not cleaned thoroughly with a brush and scrubbed and then is put into a sterilizer, so the concern was then the scope used on the next patient may still have material in it that can then transmit either HIV, hep B or hep C."
Benadé said if blood tests show anyone contracted HIV or any other disease at the hospital, officials will search for patients from even earlier dates.
Emergency and acute-care patients at the hospital in east-central Alberta are being sent to other nearby hospitals, and medical equipment requiring sterilization is also being sent to other hospitals.
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March 21st, 2007
Addictive Personalities
Nature Reviews Neuroscience 8, 246 (April 2007)
Leonie Welberg
Drug abuse has long been associated with impulsivity and alterations in the dopamine system, but the question remained of whether these features precede or follow drug use.
A recent study in Science shows that the former is the case: impulsive rats, which had never before been exposed to cocaine, self-administered more of the drug than non-impulsive rats. Moreover, the higher the rats' pre-drug impulsivity levels, the fewer dopamine D2/3 receptors they had in the nucleus accumbens, a brain structure known to have a role in motivation and reward.
Lesley King-Lewis, from Action on Addiction, says the study is interesting because it "has identified a biological basis in rats for some of the behaviours ... and shows how they can lead to drug addiction" (BBC News Online, 1 March 2007).
Some researchers warned against overestimating the predictive power of dopamine receptor levels. They can also be associated with traits like "social phobia, obsessive-compulsive disorder, social detachment and increased age," says Diana Martinez, from Columbia University Medical Center in New York City (Scientific American, 1 March 2007).
However, the study "... identifies a target," says Michael Nader, of Wake Forest University in Winston-Salem, North Carolina, USA. "If you have low D2 levels you're more vulnerable" (Scientific American, 1 March 2007). Gerome Breen of the Institute of Psychiatry in London, UK adds: "we can start to investigate treatments that ... correct this deficit" (BBC News Online).
However, the findings do not mean that people who are impulsive or have lower numbers of D2/D3 receptors are predestined to become addicts. As Gerome Breen observes, "The biggest determinant in who will become an addict is whether they actually take the drug in the first place and whether it is available to them" (The Guardian, 2 March, 2007).
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Give Prison Inmates Free Needles, Agency Suggests to Yukon Gov't
http://www.cbc.ca/
CBC News
Outreach workers have asked the Yukon government to consider providing free needles for inmates at a new prison in Whitehorse, in order to curb the spread of HIV and hepatitis C.
The Blood Ties Four Directions Centre, a Yukon agency for people with HIV and hepatitis C, argues that it makes economic sense to include prevention programs as it looks into redeveloping the Whitehorse Correctional Centre.
Executive director Patricia Bacon said Tuesday that the Yukon government already supports programs such as the outreach van that provides free needles to drug addicts on the streets of Whitehorse. But that support stops when the addicts are in prison, she said.
The territorial government is currently reviewing all aspects of the correctional centre, where Bacon said as many as one in every four inmates already have hepatitis C and are putting others at risk.
"[It's] around the 25 per cent range for hepatitis C in prison systems across Canada" compared to two per cent of the general population, she said.
The government could provide inmates with free needles, condoms and clean tattooing equipment to keep those numbers from rising, Bacon said.
"It's about having courage to take it on and seeing the long-term benefits to society, both economically and in terms of the health of the populace," she said.
"We'd love to see Whitehorse Corrections be perhaps leaders in the correction centres and the corrections field in Canada, in taking on harm reduction programs more thoroughly in the Whitehorse Correction Centre. I think it's really important."
She added that giving an inmate with a drug addiction a free needle would cost about 11 cents, compared to the hundreds of thousands of dollars in health-care system costs in treating an inmate who contracts hepatitis C.
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Fighting for Her Father
By Rachel M. Collins
news@seacoastonline.com
YORK, Maine "" Katie Prouty's desire is simple "" to help find a cure for a disease that has made her father's life a struggle.
After watching her father, Bob, become debilitated by the hepatitis C virus he contracted nearly 30 years ago from a blood transfusion following a military accident, Prouty decided she had to do something.
"She said, ‘What can I do? How can I make a difference?'" said Katie Prouty's mother, Cindy Prouty. "And she wanted to know, ‘How do they cure this?'"
Unfortunately, Katie found out, there is no cure for the most common blood-borne infection in the country.
Rather, in cases like her father's, a patient's liver is ravaged, leaving a liver transplant as the only option for treatment.
After Cindy explained to her daughter that the only way to help may be raising money for research to try to find a cure, Katie was on her way.
"She said, ‘OK,'" Cindy said. "What do you do when your daughter looks at you and says she's going to save the world?"
In this case, Cindy encouraged her daughter to work with others like Robin Cogger, of the York Parks and Recreation Department, to begin organizing a road race in her hometown to raise money for the American Liver Foundation to research hepatitis C.
The first race, held in 2006, brought in $5,000.
The second "" slated for May 20 "" could be even bigger.
That's partly because Katie's efforts recently were highlighted in a national teen magazine, Six78th.
The magazine's profile of Katie focused on her motto that even "kids can make a difference."
"I want kids to know that they do have a voice and they can accomplish something if they try to," said the 15-year-old York High School sophomore.
Certainly, she should know.
Once again, she will be spearheading the Dragonslayer 6K Road Race with the help of the Parks and Recreation Department, York High School, York Police Department and many other individuals and local businesses. The name for the race comes from the nickname for hepatitis C "" the "black dragon" "" because "it waits and builds up all its steam, then blows out all its fire and just destroys the body," Katie said.
"It's a lot of work, but it's worth it in the end," said Katie, who manages to fit in school work, family and more than 20 hours a week at Atlantic Gymnastics in Portsmouth.
She also pushes hepatitis C awareness to the forefront at every opportunity.
For instance, Katie is quick to point out that nearly 4 million Americans have been infected with the disease, yet only about 1 million know it, and it often takes between 20 and 30 years before symptoms "" like jaundice, nausea and fatigue "" appear.
Katie has hit some roadblocks. Last spring, she was asked to speak to hundreds of people at the U.S. Capitol.
"God bless this little 14-year-old getting up in front of all of these people who had denied funding for her father's transplant (through the Veterans Affairs health system)," Cindy said.
Sensing that the audience was not taking her seriously, her daughter told the group, “‘Since you're killing my father with a flick of a pen, which one of you will walk my sister and I down the aisle when we get married?'" Cindy said. "She quieted the room. What do you say when your daughter just gets it?"
Bob Prouty, who many days spends 18 hours sleeping, said he is "amazed" Katie is "trying so hard for me and others who have this disease."
"I never imagined that a child of mine could do so much and make such a difference in the world," he said.
Yet Katie is not alone. Her 10-year-old brother, Matthew, was featured in a Washington, D.C., newspaper for his fight to save his dad with legislation he wrote with his class, and her 8-year-old sister Rebecca helps where she can, especially on race day.
"If you don't tell them they can't," said Cindy, "then, of course, they can."
Go & Do
WHAT: Dragonslayer 6K Road Race and fun run
WHEN: May 20 at 10 a.m.
WHERE: Starting at York High School (fun run on Ocean Avenue after the 6K).
COST: 6K registration is $12 in advance or $15 on race day; fun run is $5
WEB: Register or find details at www.dragonslayer6K.org
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No Risk from Hepatitis C Dentist
http://news.bbc.co.uk
There is no evidence that a dentist suffering from hepatitis C infected any patients, a report by the National Public Health Service for Wales says.
Half of the 5,000 patients at the unidentified Gwynedd dental practice were tested for the virus.
Eleven patients did return positive results, but all had different types of hepatitis C from the dentist.
However, the report found some gaps in the system, which it asked the Welsh Assembly Government to review.
On Wednesday, a 77-page report was published on the findings of the team set up to investigate any possible risk from the dentist since he tested positive in October 2005.
The National Public Health Service (NPHS) in Wales, working with the Gwynedd Local Health Board (LHB), referred the finding to the United Kingdom Advisory Panel where experts decided what action should be taken.
They recommended the matter be investigated because there was "concern about infection control practices" where the dentist worker worked.
According to Dr Sandra Payne, regional director of public health for the NPHS, it was a "belt and braces approach."
She said the results of the report - which does not identify the worker or confirm he is a dentist - were as they expected.
She added:"We have found no evidence of anyone being infected with hepatitis C by the healthcare worker or at the healthcare worker's place of work.
"The numbers of patients who tested positive for hepatitis B and C are what we would expect in a population of this size.
"There is no evidence of a single patient being infected with hepatitis by blood-to-blood contact with another of the health care worker's patients.
'No greater risk
"Overall, the evidence shows that patients of the healthcare worker are at no greater risk of infection than the wider population. As such, there is not need for any further action."
Dr Payne said the incident management team behind the investigation has recommended the assembly government to consider its findings.
"There are issues around the inspection and regulation of healthcare workers in private practice and around the occupational health services available to such workers," she added.
She said gaps in the system leave certain types of private healthcare "beyond inspection and regulation and where there is no support to the healthcare worker".
Grace Lewis-Parry, chief executive of Gwynedd LHB, said 100 staff worked on the "look-back" exercise.
Letters to patients, with staff overtime and telephone calls, were estimated to have cost between £10,000 and £12,000.
The laboratory costs for blood tests was around £50,000.
She said it was impossible to measure the staff costs, because employees stopped doing other work and "concentrated on priorities".
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Chinese Worker Loses His Job because He Has Hepatitis and Takes His Life
http://www.asianews.it
Beijing (AsiaNews) – A worker from the central province of Hubei hung himself shortly after he was rejected employment because he had hepatitis B. Southern Metropolitan News said Li Zhimin killed himself in his home next to the Zhongshan factory after discovering he had not been hired.
According to the report, Li had been to an interview at the Galanz (household appliance factory) and had passed all the preliminary phases of the interview. Before obtaining the job, however, a medical exam revealed the presence of the disease and the worker was denied employment.
Before dying, Li had told a friend he would have been ashamed to return home without money.
The Maxin police, who was responsible for the investigation, confirmed that it was a suicide. But an official explained “ it is difficult to say how much the rejection influenced his decision to take his life since we did not find a suicide letter.”
The human resources department at Galanz confirmed denying Li the job claiming the virus was “in active reproduction phase, and he could have transmitted the virus to other workers”. Yet, medical research has proven that hepatitis cannot be transmitted through normal human contact. Zhou Litai, attorney, claims the factory violated the labor law and Li’s rights, however, they cannot be held legally responsible for his death.
Similar cases in China involving hepatitis patients are currently being debated. In addition, the national press spoke to a Henan university graduate that filed a lawsuit against Nokia’s Dongguan branch for having dismissed him due to the fact that he was carrying the virus. A similar situation applies to a worker from Hubei, who brought VTech Holdings to court on the grounds of discrimination.
China has 130 million carriers of the hepatitis B virus and over 30 million are infected. The discrimination towards these people is common, in particular against those who are seeking work.
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Vertex Shareholders Stay Vexed
http://www.thestreet.com
By Adam Feuerstein
Senior Writer
New clinical data from Vertex Pharmaceuticals (VRTX - Cramer's Take - Stockpickr - Rating) regarding its hepatitis C drug telaprevir, expected at a medical meeting next month, seem to have investors on edge.
Shares of the Cambridge, Mass.-based biotech firm continue show weakness on worries that telaprevir won't live up to expectations when new phase II data are presented at the European Association for the Study of Liver Disease meeting on April 11-15.
I last wrote about telaprevir in early February with Vertex shares at $35, at the time down from a recent high of $44. On Tuesday, the stock closed up 20 cents at $27.85.
Like then, there doesn't seem to be a specific nugget of negative information about telaprevir forcing Vertex lower (at least not that I've been able to pick up). Instead, there's a general uneasiness -- even confusion -- about the telaprevir data that Vertex will bring to the EASL meeting and how it will be interpreted by hepatitis C experts and investors.
At the risk of coming off a bit too wonky, I want to preview Vertex's upcoming EASL presentation. It may not dispel any fears, but with any hope it will make interpreting next month's data easier.
The most highly anticipated news will come from what is known as "Arm D" of Vertex's Prove 1 study. In this arm, 20 treatment-naive hepatitis C patients (those who have never taken anti-hepatitis C drugs) were given a triple combination of telaprevir plus interferon alpha and ribavirin (the latter two drugs representing the current, standard hepatitis C treatment.) Patients in this arm of the study were treated with all three drugs for 12 weeks, then all treatment was stopped.
Twelve weeks after stopping treatment, patients are being analyzed to see whether the hepatitis C virus in their system remains at undetectable levels. In hepatitis C circles, this is what's known as a "sustained virologic response," or SVR. Since SVR, in this case, is being measured 12 weeks after treatment ends, the data that Vertex will share at the EASL meeting will be SVR12 (from Arm D of the Prove 1 trial, to be exact.)
"This will be the first time in a clinical trial that any [hepatitis C] infected patient will have systematically been stopped at 12 weeks to see whether or not they can achieve SVR or not," explained Vertex's Chief Medical Officer John Alam at an investor conference last week.
What makes these data so intriguing is that they represent Vertex's home-run strategy with regard to telaprevir, because 12 weeks on a drug would be the shortest treatment ever conceived for hepatitis C patients. Currently, hep C patients, like those enrolled in Prove 1, need to be treated for 48 weeks with interferon and ribavirin before they can be cured.
Naturally, an aggressive stab at a 12-week treatment schedule is a risky strategy for Vertex, so the other arms of the study are exploring different treatment regimens: all dose telaprevir for 12 weeks like in Arm D, but they also extend interferon-ribavirin treatment for longer periods.
Believe it or not, that's the easy part of understanding the upcoming data. Now, we get to the complexities.
If all 20 patients in Arm D of the study were to make it through 12 weeks of treatment and 12 weeks of observation, interpreting the SVR12 data would be relatively easy. We'd just take the number of patients with undetectable virus and divide by 20 to come up with an answer.
Unfortunately, it's very possible (and probably likely) that not all 20 patients in Arm D make it through 12 weeks of treatment. (And remember, these patients are getting telaprevir, interferon alpha and ribavirin.)
According to criteria built into the Prove 1 study design, Arm D patients have to achieve undetectable levels of virus at four weeks and 10 weeks of treatment in order to stop treatment altogether at 12 weeks. If a patient doesn't meet this interim efficacy hurdle, doctors will order patients to continue receiving interferon and ribavirin for an extended period beyond 12 weeks.
Since these "nonresponding" patients will still be receiving treatment for their hepatitis C, Vertex won't be able to analyze them for SVR12 response. The denominator for the Arm D analysis, therefore, will be something less than 20 patients.
And this is where investors will have to pay close attention to how Vertex reports the data. Here's why:
Let's assume that Vertex tells us that 13 patients in Arm D achieved an SVR 12 weeks after stopping treatment with telaprevir, interferon and ribavirin. Furthermore, Vertex tells us that four patients were deemed "nonresponders" and are therefore still being treated with interferon-ribavirin beyond 12 weeks.
What's the SVR12 result for Arm D of the study? Using the most generous analysis, the SVR12 would be a robust 81% (13/16 patients). But using a stricter calculus, the SVR12 would be a less rosy 65% (13/20 patients).
For this reason, pay attention to both the numerator and the denominator used to analyze the upcoming telaprevir data. There are pros and cons for using either calculation, which go a long way toward explaining why there's so much uncertainty about the upcoming presentation. (And I did warn you that this column would get wonky.)
Other things to keep in mind about the upcoming data:
Pay attention to the side-effect profile of telaprevir and the reporting of any toxicities or adverse events that might have caused patients to discontinue treatment.
The SVR12 data will be a good measure of telaprevir's efficacy, but it's not enough. For a hepatitis C drug to receive FDA approval, patients must have undetectable virus for 24 weeks, or six months, following the end of treatment. Generally speaking, about 50% of treatment-naive hepatitis C patients are cured (achieve SVR24) on the currently marketed drugs.
If Vertex doesn't succeed with its home-run strategy of treating patients for only three months, the game is far from over. As I said above, the majority of patients in the Prove 1 study are being treated with three months of telaprevir in combination with either 24 or 48 weeks of interferon and ribavirin.
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Outpatient Medication Errors Common among Transplant Patients
www.eurekalert.org/
Medication errors appear to be common, often hidden and associated with adverse events among patients receiving outpatient care after an organ transplant, according to a report in the March issue of Archives of Surgery, one of the JAMA/Archives journals. The health care system is involved with nearly one-third of these errors.
Medication use is increasingly common - more than 60 percent of U.S. adults ages 45 to 64 reported using at least one prescription drug during the previous month when surveyed from 1999 to 2000, according to background information in the article. Medication errors are common as well, with adverse drug events reported among 6.5 percent of hospitalized patients. "It seems logical that the additional degrees of freedom introduced in the outpatient setting by the patient, caretaker, outside pharmacy or third-party payer will result in greater confusion and error," the authors write. "Examples of the types of serious errors anecdotally reported to date in this setting include mix-ups between sound-alike and look-alike drugs, similar looking packaging and inappropriate dosing."
Amy L. Friedman, M.D., and colleagues at the Yale University School of Medicine, New Haven, Conn., documented medication errors that occurred among all recipients of liver, kidney and pancreas transplants who were tracked by the Yale New Haven Organ Transplantation Center between April 1, 2004, and March 31, 2005. "At every encounter, the home medication regimen is reviewed with the patient by a nurse-coordinator, physician associate or physician and compared with the regimen prescribed at the last interaction with the patient," the authors write. Encounters include outpatient or emergency department visits, admission to the hospital or phone conversations.
During the study period, the researchers identified 149 medication errors in 93 patients, who were taking an average of 10.9 medications each. The most frequent type of error (56 percent of all errors) was patient error. An additional 13 percent of the errors were prescription errors; 13 percent were delivery errors; 10 percent were availability errors, when a patient did not have at least a 24-hour supply of a medication; and 8 percent were reporting errors, which occurred when a patient could not give the researchers enough information to identify the type, dosage, or frequency of a medication. Adverse events were associated with 48 (32 percent) of the errors, including 17 hospitalizations, three outpatient procedures, nine episodes of rejection and six failed transplants.
The researchers also pinpointed the root causes of the errors. "The root cause was defined as a specific underlying cause that can reasonably be identified, that is in the control of the transplant team to fix and for which effective recommendations for preventing recurrences could be generated," the authors write. The root causes were identified as the patient in 68 percent of the errors, financial issues in 5 percent and health care providers in 27 percent, including 10 percent caused by the transplant team itself.
Understanding the root causes of medication errors, which often stem from communication failures, should help remove the judgmental lens through which non-adherence to drug therapies is often viewed, the authors conclude. "We should strive to continue to eliminate health care system - based errors through centralized records and other streamlining methods to improve processes. In doing so, it seems likely that our patients will gain confidence in us and our ability to help them navigate a complex and confusing system." This will both improve patient safety and facilitate the shift from a culture of blame to a culture of prevention, they note.
(Arch Surg. 2007;142:278-283.)
This research was funded under a grant from the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
Contact: Jacqueline Weaver
JAMA and Archives Journals
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March 22nd, 2007
Finding Dirty Needles
http://www.registerguard.com/
A Register-Guard Editorial
If appreciative citizens have not yet presented HIV Alliance volunteer Joe Ferguson - the best used-syringe retriever money didn't have to buy - with a couple of pairs of needle-proof gloves, it must be because they missed reporter Jack Moran's story in last Sunday's Register-Guard.
Moran introduced readers to local hero Ferguson, a 38-year-old former Marine reconnaissance swimmer who spends hours of his free time each week searching for and disposing of used needles that have been discarded by drug users. He works barehanded with a "garbage grabber" tool to snag dirty needles.
With an estimated 10,000 injection drug users in Lane County shooting heroin and methamphetamine - often several times a day - Ferguson has his work cut out for him. He and his helpers on the Sana Neighborhood Needle Awareness Program cleanup crews have picked up and safely disposed of about 600 dirty needles since January. Each used needle is a potential carrier of deadly blood-borne diseases such as hepatitis C and HIV.
That might seem like a lot of hazardous waste being scattered throughout the parks, alleys and homeless camps in the Eugene-Springfield area. In reality, Ferguson retrieves just a fraction of what could be out there if it weren't for the enormously successful needle exchange programs offered by HIV Alliance and the Lane County Public Health Department.
HIV Alliance distributed 540,000 needles to injection drug users last year. About 98 percent were returned and exchanged for clean syringes. Such exchange programs play a major role in preventing the spread of HIV and hepatitis C that would result from drug users sharing dirty needles.
Not only do the programs reduce the spread of infection without increasing illegal drug use, they also provide an increasingly important avenue for addicts to learn about treatment options. Research confirms that outreach to drug users through needle exchange programs helps users reduce risky behaviors, inject drugs less often and enter substance abuse treatment.
Hepatitis C leads to chronic liver disease in 70 percent of those infected. An estimated 50 percent to 80 percent of injection drug users in the United States are infected with hepatitis C within five years of first injecting drugs. Treating a single case of HIV - the virus that causes AIDS - can cost upward of $200,000.
That makes the HIV Alliance's $145,000 a year needle exchange program a bargain that Lane County can't afford to pass up. But the Alliance's bare-bones funding doesn't leave a cent left over to pay for its needle cleanup program.
Ferguson and his fellow volunteers are making Lane County's parks and public areas safer for everyone, especially children.
Citizens could make the work safer for these volunteers by donating needle-proof gloves, biohazard containers or the money to purchase them.
To learn more, to volunteer or to report discarded needles, call the HIV Alliance's Neighborhood Needle Awareness Program at 510-1058. Few programs offer so much to so many for so little.
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Exhibition Promotes Blood Disease Awareness
http://www.mk-news.co.uk
BREAKING NEWS
An exhibition of three metre high portraits of hepatitis C sufferers were on display at thecentre:mk this week as part of a campaign to raise awareness about the blood-borne virus.
The display was opened by Milton Keynes sufferer Dean Coffey on Thursday in Queens Court.
The awareness campaign supports implementation of the Government's Hepatitis C Action Plan for England which aims to improve the prevention, diagnosis and treatment of the virus.
It is estimated about 200,000 people in England have chronic hepatitis C infection, the majority of whom are probably unaware of the condition which can cause serious liver damage.
The three-metre high portraits on display are of people from across the country, all of whom have lived with hepatitis C, including Mr Coffey.
They were taken by photographer Michele Martinoli, who has herself been successfully treated for the virus.
Mr Coffey said: "I'm proud to put my face and name to such an important campaign which through raising awareness of hepatitis C, should help to prevent new infections and encourage those who have been at risk of infection to get tested.
"I also hope that a better awareness of hepatitis C will ensure people get the care and support they need if they are affected."
Consultant Gastroenterologist at Milton Keynes General Hospital Dr Ravi Madhotra said: "We are delighted this awareness event has come to Milton Keynes.
"As hepatitis C very often has no symptoms, it's crucial that people know about the disease and how it's transmitted so that new infections can be prevented and those at risk of infection can seek testing, as effective treatment is available."
Hepatitis C is usually spread by the transfer of blood from person-to-person, for example through medical treatment abroad in countries in which it is common and infection control measures may be inadequate or by sharing of needles or syringes when injecting drugs.
Those at risk include people who have had a blood transfusion before screening for hepatitis C was introduced in the UK in 1991.
The virus can also be spread through unprotected sex or tattoos and body piercings where unsterile equipment is used.
The Hepatitis C Information Line is 0800 451 451 (textphone 0800 0850859) and open from 7am-11pm, 7 days a week for confidential information and advice. Further information on hepatitis C is also available at: The NHS Hepatitis C website
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The American Liver Foundation Urges Cautious Optimism about CDC Report on Declining Acute Hepatitis Infection Rates
http://sev.prnewswire.com
Focus Must Remain on the Millions Still Suffering from Chronic Hepatitis B and C
NEW YORK, March 21 /PRNewswire/ -- The Centers for Disease Control and Prevention (CDC) has reported that significant decline in the rates of new acute hepatitis infections in the United States in the last 10 years, reflecting the success of hepatitis A and B vaccination programs. The American Liver Foundation wants to highlight these positive results, but remind people that chronic hepatitis B and C are very serious diseases that affect over five million Americans and that the prevalence of chronic hepatitis C infection is actually increasing. This is in response to the article "Surveillance for Acute Viral Hepatitis -- United States, 2005," published by the CDC in their publication Morbidity and Mortality Weekly Report.
Acute, or short-term, infections are more common with hepatitis A and B and less likely to cause serious health problems than a chronic, or long-term, infection. Hepatitis A does not cause chronic infections. Only five percent of all adults infected with hepatitis B develop chronic infection, although 90 percent of infants infected with hepatitis B do develop chronic hepatitis B. On the other hand, hepatitis C becomes a chronic infection for 70-80% percent of those exposed to the virus.
"I was very pleased to read this report about the decline in acute hepatitis infections," said Dr. James Boyer, Chair of the Board of the American Liver Foundation and Director of the Liver Center at the Yale University Medical School. "But this good news must not let us forget the millions of Americans suffering with chronic hepatitis. Without diagnosis and treatment these people are in serious risk of developing cirrhosis and liver cancer. Much more work needs to be done to combat hepatitis in this country."
With nearly two percent of Americans infected with the hepatitis C virus, the costs of this disease to the health care system is severe. A study conducted in 2002 estimated total medical expenditures for people with hepatitis C at $15 billion per year. The projected direct and indirect costs of hepatitis C, if infection rates do not continue to drop significantly, will be $85 billion for the years 2010-2019 as the number of people chronically infected will continue to increase.
Facts about hepatitis
- There are five distinct types of hepatitis: A, B, C, D, and E. All cause inflammation of the liver
- The hepatitis B virus is 100 times more infectious than HIV
- It is estimated that there are 1.4 million Americans with chronic hepatitis B
- Hepatitis B and C can lead to liver cancer
- There are vaccines for hepatitis A and B. There is no vaccine for hepatitis C
- Hepatitis C is the most common blood-borne infection in the United States
- Almost 4 million Americans, or 1.8 percent of the U.S. population, are or have been infected with hepatitis C
- Recent studies suggest that approximately 40 percent of the 2.2 million people in America's prison system are infected with hepatitis C
About the American Liver Foundation
The American Liver Foundation is the nation's leading nonprofit organization promoting liver health and disease prevention. ALF provides research, education and advocacy for those affected by liver-related diseases including hepatitis. Please visit the American Liver Foundation's Web site at http://www.liverfoundation.org/
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Peregrine Pharmaceuticals Completes Patient Enrollment in Bavituximab Combination Therapy Trial in Advanced Cancer Patients
http://www.redorbit.com
TUSTIN, Calif., March 22 /PRNewswire-FirstCall/ -- Peregrine Pharmaceuticals, Inc. , a clinical stage biopharmaceutical company developing targeted therapeutics for the treatment of cancer and hepatitis C virus (HCV) infection, today announced that enrollment of the planned 12 evaluable patients in its Phase lb cancer trial has been completed. This trial at clinical sites in India is designed to assess the safety of bavituximab in combination with common chemotherapy agents in advanced cancer patients with metastatic disease who had failed prior therapy. Data from this study are expected to support the initiation of Phase II cancer trials later this year.
To date, the safety profile of bavituximab in combination with chemotherapy appears similar to that seen in advanced cancer patients undergoing chemotherapy treatment alone. Nine patients have completed their course of therapy and have been assessed for tumor response at the eight week scheduled MRI or CT scan. Of these, more than half of the patients achieved either disease stabilization or an objective tumor response. "Disease stabilization" is defined as less than a 20% increase in the size of the tumor up to a 30% reduction in tumor size, while "objective response" is defined as greater than a 30% reduction in tumor size. Both stable disease and objective response are considered potential signs of anti-tumor activity. Patients demonstrating either an objective tumor response or stable disease have been offered continued treatment with the combination regimen on a compassionate use basis.
"We are encouraged by the results seen to date in this first test of bavituximab in combination with common chemotherapy regimens," said Steven W. King, president and CEO of Peregrine. "Achieving stable disease and objective responses in these very ill advanced cancer patients is a promising sign, and we look forward to reporting top-line results as soon as patient follow-up and data analysis are complete. We are optimistic that these results, in combination with data from our ongoing U.S. Phase l cancer trial, will support advancing bavituximab into more extensive combination therapy cancer trials later this year."
The Phase Ib open label trial is designed to characterize the safety, tolerability and pharmacokinetics of bavituximab given in combination with standard chemotherapy regimens including docetaxel, gemcitabine and carboplatin/paclitaxel. These regimens are commonly used for treating major solid cancers, and the enrolled patients include those with breast, ovarian and lung cancers. Study patients are considered enrolled and evaluable for safety analysis after completing four of the planned eight weekly doses of bavituximab in combination with chemotherapy. The chemotherapy agent was administered for up to eight weeks on its standard prescribed administration schedule. Patients are also being evaluated for tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) parameters, receiving CT or MRI scans prior to therapy and at week eight, although this assessment is not a formal endpoint of the study.
Study participants are being followed for an additional four weeks after their last dose of bavituximab. Patients with stable or improved disease may continue with chemotherapy and bavituximab on a compassionate use basis. The trial is being conducted according to International Conference on Harmonization (ICH) and Good Clinical Practices (GCP) guidelines.
Bavituximab is a monoclonal antibody that targets and binds to a phospholipid called phosphatidylserine, which is located on the inside of normal cells but which becomes exposed on the outside of the cells that line the blood vessels of tumors, creating a specific target for anti-cancer treatments. Bavituximab is currently in clinical trials in the U.S. and India for the treatment of solid tumors and in the U.S. as a treatment for chronic hepatitis C infection. Extensive preclinical data demonstrate good anti-tumor activity in a variety of tumor types, especially when bavituximab is administered in combination with chemotherapy or radiation.
About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio of innovative product candidates in clinical trials for the treatment of cancer and hepatitis C virus (HCV) infection. The company is pursuing five separate clinical trials in cancer and HCV infection in the U.S. and India with its lead product candidates bavituximab and Cotara(R). Peregrine also has in-house manufacturing capabilities through its wholly owned subsidiary Avid Bioservices, Inc. (http://www.avidbio.com/), which provides development and bio-manufacturing services for both Peregrine and outside customers. Additional information about Peregrine can be found at http://www.peregrineinc.com/.
SafeHarbor Statement:
Statements in this press release which are not purely historical, including statements regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements involve risks and uncertainties including, but not limited to, the risk that bavituximab will not work as well in other chemotherapy regimes and the risk that the results of future larger trials will not correlate to the results of this smaller Phase Ib trial. It is important to note that the company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, uncertainties associated with completing preclinical and clinical trials for our technologies; the early stage of product development; the significant costs to develop our products as all of our products are currently in development, preclinical studies or clinical trials; obtaining additional financing to support our operations and the development of our products; obtaining regulatory approval for our technologies; anticipated timing of regulatory filings and the potential success in gaining regulatory approval and complying with governmental regulations applicable to our business. Our business could be affected by a number of other factors, including the risk factors listed from time to time in the Company's SEC reports including, but not limited to, the annual report on Form 10-K for the year ended April 30, 2006, and the quarterly report on Form 10-Q for the quarter ended January 31, 2007. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release.
Contacts:
GendeLLindheim BioCom Partners Investors Media info@peregrineinc.com
Barbara Lindheim (800) 987-8256 (212) 918-4650
Peregrine Pharmaceuticals, Inc.
CONTACT:
Investors, info@peregrineinc.com, 1-800-987-8256, or Media,Barbara Lindheim, +1-212-918-4650, both of GendeLLindheim BioCom Partners, forPeregrine Pharmaceuticals, Inc.
Web site: http://www.peregrineinc http://www.avidbio.com/
Source: PRNewswire-FirstCall
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Saliva Tests Making Their Way to Routine Care
http://www.washingtonpost.com
By Alan Mozes
HealthDay Reporter
THURSDAY, March 22 (HealthDay News) -- Simple, cheap diagnostic tests based on the analysis of saliva are within spitting distance of development, says a consortium of American researchers.
Scientists say the novel protocol could be available as a standard of care as early as 2011 to screen for a variety of major diseases.
"The ability to detect and monitor diseases through noninvasive means is a highly desirable goal in health care," said Dr. David T. Wong, director of the Dental Research Institute at the University of California, Los Angeles. "Saliva, a totally noninvasive fluid, holds this ability but is not currently used in (the) mainstream. All of this is just about to change."
Wong was scheduled to describe the new tests Thursday at the International Association for Dental Research annual meeting, in New Orleans.
To develop the saliva-based screens, Wong has teamed up with researchers at the U.S. National Institute of Dental and Craniofacial Research; the University of California, San Francisco; and the Scripps Research Institute.
Together, the team is engaged in a painstaking mapping of so-called "diagnostic alphabets" present in saliva. Identifying the components of such alphabets is key to "reading" the signs of disease.
So far, two such alphabets are substantially decoded: one based on salivary proteins and another based on salivary messenger RNAs (mRNA) -- molecules integral to the formation of proteins.
More than 1,500 salivary proteins have been identified, the authors noted, alongside about 3,000 mRNAs.
Based on their detective work, Wong's group announced that their research has already uncovered indicators pointing the way toward diagnosing both oral cancer and an autoimmune illness called Sjogren's syndrome.
He noted that oral cancer can be identified in saliva by screening for five specific proteins and four mRNAs that form a unique diagnostic signature in more than 90 percent of cases.
Similarly, a small subset of proteins and mRNAs appears to serve as markers for Sjogren's syndrome.
Early detection of oral cancer via saliva testing could potentially help boost survival rates among the more than 31,000 Americans that the American Cancer Society estimates are currently diagnosed with some form of oral cancer each year. Approximately 7,000 men and women die from the disease annually.
An even larger patient pool now combats Sjogren's syndrome, a disorder in which white blood cells attack moisture-producing glands, causing dry eyes and dry mouth. The syndrome affects upwards of 4 million Americans.
The potential of the work now under way by Wong and his team is supported by experts at the American Association for Dental Research. They believe that saliva, like blood and urine, can be viewed as a repository of important information on illness and exposure to environmental substances.
Already, new tests are being developed that use saliva to detect measles, mumps, rubella, hepatitis (A, B and C), breast cancer, Alzheimer's disease, and cystic fibrosis.
In 2004, the U.S. Food and Drug Administration (FDA) approved a saliva-based test for HIV, the virus that causes AIDS. Future diagnostic tests may also ultimately rely on saliva for indications of unhealthful exposure to lead, as well as to monitor abuse of drugs or alcohol.
Wong said that the objective is to place easy-to-use saliva-screening technologies in the hands of physicians, dentists and nurses as quickly as possible.
"This is truly an exciting and revolutionary goal," he said, adding that current efforts aim "to establish the scientific credibility and clinical utilities of saliva."
Dr. Robert Genco is a distinguished professor of oral biology and microbiology in the Schools of Dentistry and Medicine at the State University of New York in Buffalo. He agreed that saliva-based diagnostics show real promise.
"The field is very exciting, and the quest for such diagnostics is important," he said. "Because if you can take a simple sample like saliva and then do a test to diagnose disease -- particularly for diseases that don't show themselves very well -- you can perhaps have some information before the situation gets too serious."
"The key issue is what is the predictive value or reliability of such a test in an individual. And that's a very high barrier to overcome," he cautioned. "But I think the cutting-edge approach these researchers are using is sensible and holds a great deal of promise."
More information
For more on saliva diagnostics, visit the American Association for Dental Research.
SOURCES: David T. Wong, M.D., director, Dental Research Institute, University of California, Los Angeles; Robert Genco, DDS, Oh.D., distinguished professor of oral biology, School of Dentistry, and professor of microbiology, School of Medicine, State University of New York at Buffalo, N.Y., March 21-24, 2007, General Session of the International Association for Dental Research, New Orleans.
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March 23rd, 2007
Gov't Again Ordered to Pay Damages over Hepatitis C Virus Infection
http://www.therapeuticsdaily.com
Japan Economic Newswire
TOKYO, March 23_(Kyodo) _ The Tokyo District Court joined two other district courts Friday in ordering the government to pay damages to people infected with the hepatitis C virus after being treated with tainted blood products.
Presiding Judge Atsuo Nagano, acting on a 1,353 million yen damages suit, ordered the state of Japan and three drugmakers to pay a total of 259 million yen to 13 out of the 21 plaintiffs.
Last year, the Osaka and Fukuoka district courts ruled similarly, saying the government failed to implement necessary regulations against infections.
Hepatitis C is a blood-borne, infectious viral disease. The hepatitis C virus can cause liver inflammation that is often asymptomatic, but ensuing chronic hepatitis can result later in cirrhosis and liver cancer. An estimated 2 million people have been infected with the hepatitis C virus.
The defendants in the suit were the state, Mitsubishi Pharma Corp., its subsidiary Benesis Corp. and Nihon Pharmaceutical Co. Mitsubishi Pharma is the successor to the now-defunct major blood product maker, Green Cross Corp.
The three-judge panel at the Tokyo court found that the plaintiffs were given hepatitis C virus-tainted blood products -- fibrinogen, christmassin or PPSB-Nichiyaku -- from 1980 to 1988 to stop bleeding when they underwent surgical operations or gave birth to babies.
Fifteen of the 21 plaintiffs were given fibrinogen, four christmassin and the remaining two PPSB-Nichiyaku. Three of them developed cancer, of whom two have died.
Of the remaining 18, 13 people have been suffering from chronic liver inflammation while the other five have yet to develop any diseases.
During the court battle, the plaintiffs argued that the government failed to take any regulatory measures after approving the production of the tainted blood products which they said were useless and dangerous.
The defendants contended that the blood products were useful and that the 20-year statute of limitations has run out for the plaintiffs to demand damages.
A total of about 160 people have filed damages suits against the state and drugmakers at Tokyo, Osaka, Nagoya, Fukuoka and Sendai district courts seeking a combined 9.8 billion yen.
In June last year, the Osaka District Court ordered the state and drugmakers to pay a total of 256 million yen in damages to nine out of 13 plaintiffs.
Two months later, the Fukuoka District Court ordered the defendants to pay a combined 168 million yen in damages to 11 of 18 plaintiffs.
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Research from Japan, the People's Republic of China and the United States Provide New Insights into Hepatitis B Virus
www.therapeuticsdaily.com
Hepatitis Weekly - Mar. 26, 2007
2007 MAR 26 - (NewsRx.com) -- Studies from Japan, the People's Republic of China and the United States have provided new hepatitis B virus data.
Study 1: Scientists discuss in "Clinical characteristics of NonBNonC- HCC: Comparison with HBV and HCV related HCC" new findings in hepatitis B virus. In this recent report, researchers in Osaka, Japan conducted a study "To clarify the frequency and trends of both HBsAg and HCVAb negative hepatocellular carcinoma (NonBNonC-HCC) in all HCC, to clarify the etiology of NonBNonC-HCC, and to elucidate the clinical characteristics of NonBNonC-HCC compared with those of HBsAg-positive HCC (B-HCC) and HCVAb-positive HCC (C-HCC). A total of 2,542 patients with HCC examined at three institutions between 1991 and 2004 were categorized based on their serum viral antigen/antibody positivities, and compared between groups for the etiology, annual trend of the incidence, and clinical characteristics."
"For the etiology, C-HCC was most prevalent, followed by B-HCC, NonBNonC-HCC, and both HBsAg and HCVAb-positive HCC (BC-HCC) in order. For survival, C-HCC had the most favorable prognosis, followed by NonBNonC-HCC, and B-HCC patients had the poorest prognosis in the three groups (C-HCC, B-HCC, and NonBNonC-HCC). In tumor-node metastasis (TNM) stages I+II, however, NonBNonC-HCC patients took the most favorable clinical course. The incidence of NonBNonC-HCC in all HCC was 5-8% from 1991 to 1998, and has increased to 10-12% since 1999. Additionally, the incidence of HBcAb-positive HCC in NonBNonC-HCC declined each year. Among NonBNonC-HCC patients, the morbidity of diabetic complications was significantly higher in HBcAb-negative patients than in HBcAb-positive patients. Although the incidence of NonBNonC-HCC among all HCC has an increasing trend recently, the incidence of HBcAb-positive HCC in NonBNonC-HCC has a tendency of decreasing. This fact suggest its etiology might be changing from occult HBV related HCC to unknown etiology such as nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) related HCC," wrote K. Hatanaka and colleagues, Kinki University.
The researchers concluded: "The prognosis of NonBNonC-HCC was fairly good if the HCC was found in its early stage."
Hatanaka and colleagues published their study in Intervirology (Clinical characteristics of NonBNonC- HCC: Comparison with HBV and HCV related HCC. Intervirology, 2007;50(1):24-31).
For additional information, contact K. Hatanaka, Kinki University School of Medicine, Dept. of Gastroenterology and Hepatology, Osaka, Japan.
Study 2: In a recent study, researchers from the People's Republic of China reported that hepatitis B virus X (HBx) protein enhances invasive potential of hepatocellular carcinoma cells.
D.P. Ou and colleagues, Central South University, wrote that the study was done "to establish a sustaining hepatitis B virus X protein expressed Chang liver cell line and to explore their biological behaviours of invasive potential induced by hepatitis B virus X protein."
"Polymerase chain reaction was used to amplify the HBx gene front the whole hepatitis B virus genome. The gene was then subcloned into the eukaryotic expression vector pcDNA3.1 to construct the pcDNA3.1-HBx plasmid.
"Gene transfection mediated by lipofectamine was used to introduce the plasmid into the human liver cell line Chang, and stable expression of the HBx gene was detected. HBx gene was cloned from the transfected Chang liver cells by reverse transcription-polymerase chain reaction, and confirmed by electrophoresis," wrote the researchers.
"The stably transfected Chang cells expressing HBx with malignant characteristics were verified and compared with control cells in terms of their growth curves, clonogenicity, wound healing abilities, migration and metastasis," the scientists continued.
They concluded, "The stabilizing human liver cell lines Chang liver containing HBx gene expression have been established successfully. The invasive potential of Chang cells was conditionally enhanced by HBx transfection."
Ou and colleagues published their study in Digestive and Liver Disease (Hepatocellular carcinoma cells containing hepatitis B virus X protein have enhanced invasive potential conditionally. Dig Liver Dis, 2006;38(4):262-267).
For additional information, contact L.Y. Yang, Central South University, Xiangya Hospital, Department of Surgery, Liver Cancer Laboratory, Changsha 410008, Hunan, People's Republic of China.
Study 3: According to recently published research from the United States, hepatitis B virus surface antigen (HbsAg)-negative foci and hepatocellular carcinomas (HCCs) originate separately in transgenic HBsAg (Alb/psx) mice.
"We have examined the development and transgene expression in liver lesions of transgenic mice bearing the HBsAg gene of hepatitis B virus under the control of the albumin promoter (alb/psx) to study liver regeneration and HCC associated with hepatitis B virus infection," wrote D.R. Crawford and colleagues, New York State Department of Health.
"Storage of the HBsAg in the endoplasmic reticulum. precedes loss of liver cells and regenerative hyperplastic nodules that do not express HbsAg. Histological analysis indicated that HBsAg-negative foci and nodules arose from liver progenitor cells in the portal zone and lacked mRNA expression.
"Genomic DNA from eight of nine HBsAg-negative laser capture-excised liver foci showed loss of part of the alb/psx gene, whereas no loss of the actin gene was observed. The alb/psx DNA was intact in adjacent HBsAg-positive tissue," the authors reported.
"Sequencing of polymerase chain reaction products suggested that alterations in the HBsAg transgene in HBsAg-negative foci occurred via large-scale deletions as opposed to single-site mutations. Southern blot analysis of HCC from 2-year-old transgenic HBsAg mice, however, revealed an intact alb/psx gene," the investigators wrote.
"Thus," they concluded, "HBsAg-negative progenitor cells with deletions in the transgene appear to be responsible for compensatory regeneration of the liver, whereas HCCs arise from clonal expansion of hepatocytes with intact alb/psx transgenes."
Crawford and colleagues published their study in American Journal of Pathology (Separate origins of hepatitis B virus surface antigen-negative foci and hepatocellular carcinomas in transgenic HBsAg (Alb/psx) mice. Am J Pathol, 2006;169(1):223-232).
For additional information, contact S. Sell, New York State Department of Health, Wadsworth Center, Albany, NY 12208, USA.
This article was prepared by Hepatitis Weekly editors from staff and other reports.
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